Court filing
Table of Exhibits — United States v. Agnello (Dkt. 24-1, E.D.N.Y.)
Summary
Table of exhibits filed March 11, 2026 as Document 24-1 in United States v. Agnello, Case 2:24-cr-00366-NJC, in the Eastern District of New York, listing Exhibits A through X. Exhibits A to C are statements from Victoria Gotti, Kyrie Davis and Gary Davis. The rest include an inspection of the Federal Bureau of Prisons' Federal Medical Center Devens, a People article reporting that John Gotti's daughter Victoria would undergo a kidney transplant with her son as donor, medical studies of live kidney donation and dialysis, news reports of prisoners released under kidney-donation arrangements, and law review articles on the economic loss guideline and criminal deterrence. Exhibit A is a letter from Victoria Gotti to Judge Nasret Chudury about her son Carmine, whom she calls her 'Miracle Child.'
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Filed March 11, 2026 in Agnello; one of 1 filings from this case.
Record facts
| Court | U.S. District Court for the Eastern District of New York |
|---|---|
| Filed | 2026-03-11 |
Cite this document
“Table of Exhibits — United States v. Agnello (Dkt. 24-1, E.D.N.Y.).”
U.S. District Court for the Eastern District of New York, No. 2:24-cr-00366, Doc. 24-1, filed 2026-03-11. Archived at Pandemic Darlings, https://pandemicdarlings.com/court-filings/us-v-agnello/2026-03-11-table-of-exhibits-dkt-24-1/
, SHA-256 97f018f5f5de186ff812ac07da90187a36368ce1db147313ab4da3ad4da38af5.Full text
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 1 of 569 PageID #:
195
TABLE OF EXHIBITS
US V. AGNELLO, 2:24-CR-00366
Exhibit A……………………………………………… Victoria Gotti Statement
Exhibit B……………………………………………… Kyrie Davis Statement
Exhibit C……………………………………………… Gary Davis Statement
Exhibit D……………………………………………… Inspection of the Federal
Bureau of Prisons’
Federal Medical Center
Devens
Exhibit E……………………………………………… Sue Carswell, People:
John Gotti's Daughter
Victoria to
Undergo Kidney
Transplant with Her Son
as Donor, (11.25.2025)
Exhibit F……………………………………………… Author Manuscript PMC:
Risk of End Stage Renal
Disease Following Live
Kidney Donation,
(2.12.2014)
Exhibit G……………………………………………… JAMA: Perioperative
Mortality and Long-term
Survival of Live Kidney
Donation, (3.10.2010)
Exhibit H……………………………………………… US v. Lumiere, June 14,
2017 Minutes
Exhibit I……………………………………………… Law360: Risk of End
Stage Renal Disease
Following Live Kidney
Donation
Exhibit J……………………………………………… PMC: Risks of Living
Kidney Donation,
(3.11.2019)
Page i of iii
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 2 of 569 PageID #:
196
Exhibit K……………………………………………… American Journal of
Transplantation, M.
Tonelli: Systemic Review
Kidney Transplantation
Compared with Dialysis,
(6.14.2011)
Exhibit L……………………………………………… KDIGO 2017 Clinical
Practice Guideline on the
Evaluation and Care of
Living Kidney Donors
Exhibit M……………………………………………… Dr. Victor Gura, What is
the Life Expectancy of a
Person on Kidney
Dialysis, (7.14.2025)
Exhibit N……………………………………………… CBS News: Sisters Leave
Prison Under Kidney
Sharing Deal, (1.7.2011)
Exhibit O……………………………………………… Christopher Burkle MD,
Mayo Clinic Proceedings:
Mississippi Decision
Changing Parole for
Kidney Donation, (May
2011)
Exhibit P……………………………………………… Melissa Nelson Gabriel,
AP News: Women
Released from Mississippi
Prison Make Life in
Florida, (7.23.2018)
Exhibit Q……………………………………………… Kaley Johnson, The
Marshall Project: At a
Federal Prison in Texas,
Women Say Dialysis Is
Killing Them,
(12.16.2025)
Page ii of iii
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 3 of 569 PageID #:
197
Exhibit R……………………………………………… Mark Memmott, NCPR
News: Barbour was
Moving on Sisters’ Case
Before Controversial
Comments, (12.30.2010)
Exhibit S……………………………………………… National Kidney
Foundation: Kidney
Donation_ Recovery,
Health, and Life After
Surgery, (12.16.2024)
Exhibit T……………………………………………… Barry Boss and Kara
Kapp, Ohio State Journal
of Criminal State: How
the Economic Loss
Guideline Lost its Way,
(2021)
Exhibit U……………………………………………… Jaclyn Tayabji, Boston
University Law Review:
Rehabilitation Under the
Rehabilitation Act, (2021)
Exhibit V……………………………………………… OPTN Ethics: Ethical
Evaluation of Multiple
Listing, (June 2023)
Exhibit W……………………………………………… A. von Hirsch, A. E.
Bottoms, E. Burney and
P-O. Wikström, Alberta
Law Review: Criminal
Deterrence and Sentence
Severity_ An Analysis of
Recent Research, (1999)
Exhibit X……………………………………………… Gary Kleck et al., The
Missing Link In General
Deterrence Research
(2005)
Page iii of iii
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 4 of 569 PageID #:
198
EXHIBIT A
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0001
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 5 of 569 PageID #:
199
Honorable Judge Nasret Chudury
U.S. District Court Judge for the Eastern District of New York
100 Federal Plaza
Central Islip, NY 11722
Dear Honorable Nasret Chudury,
I am writing to you with a heavy heart—given the circumstances.
At twenty years of age I gave birth to my daughter, Justine. She died shortly after birth.
Doctors told my husband and I, “the chances of conceiving a child were slim and none—even
after an operation to clear my left tube (my right was lost to an ectopic pregnancy just before
Justines death).”
After the death of my daughter, I went into a DEEP depression. I wouldn’t leave my
home, unplugged my phones and locked the room door and slept on the floor of what would have
been her nursery. In what I STILL deem a miracle—I was taken to the hospital by ambulance for
“severe dehydration.” Imagine my surprise and joy when the doctor came out to announce I
WAS yet again pregnant. I spent the entire seven months on complete bedrest—as per my
doctors orders and my own fear something would again go wrong.
Carmine, premature by seven weeks, at a mere four pounds and a bevy of serious
ailments, was born. Underweight, born with strabismus (an eye condition infants are born with
where all nerves are detached from his eye, a broken leg and severely clubbed foot, his liver
function severely impaired and underdeveloped and his heart impacted by a highly audible
gallop—later diagnosed as leakage of his mitral valve. After two unsuccessful (one nearly killed
him) surgeries of his eye he was deemed “legally blind in that eye. His right leg was broken
several times and reset with only a slight improvement. His liver was carefully watched over the
next few years as was his heart. For these two conditions there was little they could do to
improve. At three years old Carmine developed strep throat and given the usual course of
antibiotics, fever reducing medications and bedrest Day three he was rushed to the hospital at
3am with “sepsis,”—a life threatening illness that nearly killed him. For fourteen hours I laid in
the infant hospital crib with him—praying throughout the night. Narrowly, I was spared the
horror of losing him. Within two weeks he was back home, but under a pediatric cardiologists
cautious care until he was eighteen years of age and then moved to an adult cardiologist.
Through ALL of his ailments he fought and fought, while I prayed. I deemed him “My
Miracle Child” from that point on.
As a single mother of three sons the most difficult part of raising them was to sacrifice
EVERY dream and ideal I had for myself, to be sure each would grow up to be intelligent, kind,
compassionate respectful and hardworking men. I sacrificed my life, socially and somewhat
professionally at a young age, 37 to give raising my boys my ALL. Three jobs as a newspaper
columnist, Author and editor, took over so my sons could thrive. I have absolutely no regrets
C.Agnello SE 0002
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 6 of 569 PageID #:
200
Not one son has ever given me trouble—mainly Carmine. He was as most teachers and
peers would say, “The perfect child—The teachers pet.”
As an infant till the age of seven, Carmine never left my side. In a crowded room with
other children he would constantly look up for me—constantly needing reassurance I was
nearby. His teachers referred to Carmine as “The peacemaker—The perfect student who had a
pensity for calming down other arguing students by coming up with a desirable middle ground.”
,
Your honor, you want to know what kind of a young man Carmine is? I am sure every
parent would say that if asked about their child, “oh, he or she is the best.” —but on my life, my
upcoming transplant, THAT is the kind of young man my son is. He is there to help anyone. He
is kind and generous to a fault. He is giving me the GIFT OF LIFE. He will give his last dollar to
anyone in need. This entire event never made much sense to me from the start. My son, Carmine
would never do anything he KNEW was wrong. He did not fill out the application this seems to
revolve around—a professional did it for him. Carmine answered ALL questions via text and
phone to the best of his knowledge. There was NO attempt to defraud anyone or any institution
on his part. He was in trouble only once in his entire life—and it was MY fault. It had to do with
work and business records filed. I owned the property Carmine and his brothers had their
business on. At MY property lawyers suggestion, then he asked “why are ALL your investment
properties in one LLC?” I was just learning Myself, so I had each property changed to a different
LLC. I did not know it was imperative I change all leases to each new LLC. Carmine renewed
his business license in the old entity.
The day all of that happened I was utterly sick inside! Getting back to defrauding—he did
not. He did not know back then and that small blunder turned into a fine and sealed. Filling out
an application recently—again he answered every question honestly and openly and has texts
and phone records to prove such. The loan was to pay the DEC (department of environmental
conservation) for a business matter—a work order passed down to the then operating business(as
a result it is no longer in operation) the cost of re cementing the work space was 96 thousand
C.Agnello SE 0003
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 7 of 569 PageID #:
201
dollars alone—not counting other work the DEC wanted done; Ripping up an old scale from
underground, hauling away barrels of soil, testing of such soil and clean-up of anything
underground. Total cost so far, 496 thousand dollars. Carmine was desperately trying to save a
business, that he and his brothers started 14 years earlier during covid. Of course also keeping his
workers paid and all overhead paid. I KNOW I am the person that lent him the money before he
even knew about any such loan. I am SURE, he is MOST remorseful of ANY wrongdoing on his
part. He is not made that way to be deliberately deceitful or fraudulent. I, and many others
notated that in court the day he took a plea. That’s always been his way. If something points out
a mistake he has made he will owe up to it and he does have much remorse.
Carmine is a NON violent person, respectful to women, family and his peers. He would
never willingly harm anyone or do anything he believes is wrong. To be perfectly honest, your
honor, I don’t even believe my son knows what’s been done here? We speak about it everyday
and quite frankly, there was no malice or criminal intent—he simply would NOT know how.
I am a mother, absolutely sick and devastated my son is in this position. This is NOT the
way he was raised! Carmine walks around since this has happened in a literal “fog.” My loving,
helpful, giving son has been replaced by a young man filled with confusion and MUCH remorse
for something he is trying to figure out. I, as his parent, am MOST disturbed at all the promises
he was made by the U.S. “Pay back all the money and all will go away" Later I was told “NO
That was never said or promised.” Being a Journalist for nearly 27 years with my own front page
cover every Sunday—and the most popular weekly column at the NYPost, I have the proof of
this conversation. I was just a bit confused when my son was asked if he was promised anything
in return? To which he replied “No.” Confused? I was mystified to say the least. Carmine later
informed me, “He was instructed to say this” As I told my son, “You NEVER say anything you
do not understand especially if not written and signed in a plea agreement.” I had absolutely no
knowledge of this your honor. Though I make it my business to not advise those I love of
something I would have to live with—I would NOT have let him get into something he did not
“fully understand” especially when he had ALL bills and worksheets to prove all?
I recall the day we stood in front of you your honor and just by YOUR expression and
kind yet thorough and professional demeanor it seemed as though you too were confused as to
“why Carmine waived his right to a grand jury—and was pleading on an information.” I do not
know much about the law, but three semesters of St Johns Law school taught me the basics. (I
dropped out shortly after my doctor informed me to start a family asap if I ever intended to have
one as by age 25 I would require a full hysterectomy” I chose family and suffered much
heartache and while lying bedridden for 6 months decided to write legal thrillers—6 all of which
became NYTimes bestsellers. I followed up with writing a medical text about women and heart
disease as I was suffering from it and two family oriented cookbooks while traveling through
Italy with my children.
C.Agnello SE 0004
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 8 of 569 PageID #:
202
out of his own stupidity. (This Was Not acceptable to me) My kids ALWAYS came first—and
with much deliberation and considering the kids upbringing, I came to my decision. His money
and success meant nothing to me. I worked my way back on my own with the help of NO ONE.
It wasn’t until a year before my divorce I learned my ex-husband had been teaching my
sons to gamble—“a recreational hobby” he’d later explain to have “a common bond he would
share with the boys then barely teens to help them grow closer.” Naturally I flipped. It was the
beginning of the end. I had a few close members of my family who were gamblers one or two
lost all including their happy marriages and families. I would NOT stand for it! It caused MUCH
trouble and after the divorce I believed all of that stopped; football games, and horse racing and
other sports. To my dismay I was wrong. Unfortunately Carmine had taken the habit and
exchanged it for a connection to his dad. Sadly, once I divorced his father, my ex, in turn was so
upset about the divorce he took it out on our three young sons, then just teens. Working hard and
always on top of his bills Carmine kept all his finances in check. I had NO reason to suspect
ANY gambling was still going on—especially horse racing, a favorite past time of his Fathers.
But as God as my witness when all this came to light I put my foot down immediately and
enrolled him in a program. He has been diligent and extremely serious about the program and I
can see he learned a VERY valuable lesson. He, as I mentioned sold his house/home, he
practically renovated by himself brick by brick. He used ALL profit to pay back what he owes
and this he did of his own volition. He didn’t come crying to mommy or anyone and to date he is
well over a year paid in advance re loan.
Yes, I would do anything for my son. A gift from God I will always treasure. To say
Carmine does much much more good living his life; helping others, mentoring young men who
do not have a hands on dad, helping anyone he can financially, emotionally and compassionately
is an understatement. If my son Carmine was to be detained in a facility, I fear ALL I did raising,
C.Agnello SE 0005
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 9 of 569 PageID #:
203
teaching and instilling in him would do more harm than good. This young man doesn’t have a
violent, mean bone in his body or mind.
Fondly,
Victoria Gotti
C.Agnello SE 0006
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 10 of 569 PageID #:
204
EXHIBIT B
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0007
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 11 of 569 PageID #:
205
C.Agnello SE 0008
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 12 of 569 PageID #:
206
C.Agnello SE 0009
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 13 of 569 PageID #:
207
EXHIBIT C
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0010
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 14 of 569 PageID #:
208
C.Agnello SE 0011
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 15 of 569 PageID #:
209
C.Agnello SE 0012
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 16 of 569 PageID #:
210
EXHIBIT D
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0013
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 17 of 569 PageID #:
211
Inspection of the Federal Bureau of Prisons’
Federal Medical Center Devens
E VA L U AT I O N A N D I N S P E C T I O N S D I V I S I O N
25-009
DECEMBER 2024
C.Agnello SE 0014
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 18 of 569 PageID #:
212
Executive Summary
Our unannounced inspection identified several serious issues
at FMC Devens related to staffing, inmate healthcare quality,
infrastructure, inmate programming, failure to complete
rounds, and radio system deficiencies. Notably, substantial
shortages of healthcare employees and Correctional
Officers—which is an issue at many BOP institutions but
particularly problematic for a medical institution—have
The DOJ OIG’s Inspections Program created widespread and troubling operational challenges at
FMC Devens that substantially affect the health, welfare, and
Between Monday, April 22, and Friday April 26,
safety of employees and inmates.
2024, the U.S. Department of Justice (DOJ)
Office of the Inspector General (OIG)
Particularly concerning, we found that FMC Devens’s
conducted an unannounced, on-site
inspection of Federal Medical Center (FMC)
Correctional Services Department had only 161 of
Devens, an administrative-security medical 201 authorized positions filled (80 percent) and the Health
center housing inmates with serious medical Services Department had only 113 of 149 positions filled
or mental health conditions, in Massachusetts. (about 76 percent) at the time of our inspection. Also
The institution is composed of two sub- concerning, during the on-site portion of our inspection and
facilities: a federal medical center and a shortly thereafter, the medical institution had only 1 physician
minimum-security prison camp. Both facilities and the Clinical Director (who is also a physician) to manage
house male inmates.
the care of the entire inmate population of approximately
This was the fifth unannounced inspection of a 941 inmates: 2 of the institution’s 6 physicians were on
Federal Bureau of Prisons (BOP) institution under extended leave without pay, and 3 other physician positions
the OIG’s on-site inspections program. The first were vacant. The Clinical Director, who leads the provision of
four institutions we inspected, FCI Waseca, FCI preventive health services and provides standing orders for
Tallahassee, FCI Sheridan, and FCI Lewisburg, did
nurses, retired in June 2024; the position remained vacant as
not have a medical mission. We selected FMC
of October 5, leaving FMC Devens without this critical medical
Devens as the site of our fifth inspection to better
understand and assess the conditions of role filled and only one physician at the institution to provide
confinement at an FMC. daily patient care. Other vacancies within the Health Services
Department included approximately half of the institution’s
In this report, we make 11 recommendations
pharmacy positions, approximately a quarter of its nursing
to the BOP to ensure effective operations at
FMC Devens and safe conditions of
positions, and its Chief Dental Officer and Deputy Chief
confinement for the inmates housed there. Psychologist positions. Only 20 of 33 positions (61 percent) in
Ten recommendations relate to the quality of the Psychology Services Department were filled. We are
healthcare provided to inmates and the concerned that the staffing crisis at FMC Devens has cascading
medical care issues we identified, and one effects on its ability to care for its inmates and limits the
addresses issues at FMC Devens that we also quality and quantity of medical services it can provide,
identified in prior BOP oversight and for which including for inmates who were transferred there expressly
we have made BOP-wide recommendations.
for its specific medical programs.
We also identified concerns related to the quality of
healthcare provided to inmates, including potentially dangerous medication distribution, lack of preventive
healthcare screening, inappropriate placement of inmates in the Memory Disorder Unit (MDU), and
inconsistent processes for requesting and accessing care. Specifically, we observed BOP employees
providing buprenorphine and naloxone—controlled substances for which the BOP requires direct
supervision for the duration of medication administration and consumption to prevent diversion—to Camp
i
C.Agnello SE 0015
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 19 of 569 PageID #:
213
inmates without directly supervising them. We also found that 57 outside medical appointments for
inmates were yet to be scheduled and were on average 53 days overdue at the time of our inspection due to
outside medical providers canceling appointments and a lack of FMC Devens employees to escort inmates
to scheduled appointments while maintaining coverage of necessary posts. We also were concerned to find
that FMC Devens lacked oversight of its contracted company that manages outside medical records. This
resulted in delays in outside medical records being submitted to FMC Devens following outside office visits
and caused a significant discrepancy between the number of pending outside medical records that the
company indicated it needed to send to FMC Devens and the number of outside medical records that FMC
Devens was waiting to receive. This lack of oversight could lead to fragmented and delayed follow-up
inmate care and could exacerbate conditions that inmates were sent to outside providers to address.
We found inconsistencies regarding inmates’ access to medical care and routine screening of inmates over
age 50 for preventive healthcare and cognitive impairment, including an apparent inconsistency in how FMC
Devens nursing employees determined what constituted a need for sick call and how that need was tracked.
This inconsistency may limit an inmate’s ability to be seen and receive medication in a timely manner, which
could negatively affect their overall health. Additionally, we reviewed the medical records of a random
sample of 21 inmates over age 50 to determine whether they were receiving preventive healthcare
screenings; less than half had received a preventive health screening, and none had received a cognitive
impairment screening as part of their preventive healthcare during the previous year. Further, not all
inmates with a diabetes diagnosis were tested within required BOP guidelines and not all healthcare
provider credential files were verified as directed by BOP policy. We also found that a quarter of the
inmates were not appropriately housed in the MDU, the BOP’s only unit designed specifically for inmates
with dementia. Finally, we found that some inmates serving as medical companions were not eligible to
participate in the program and some performed duties that were both outside the scope of the program
and prohibited by the BOP. These concerns cumulatively carry multiple risks for the institution’s ability to
provide adequate, continuous, and follow-up care to inmates with medical needs.
We also identified concerning issues affecting safety and security, inmate programming, and infrastructure.
First, Correctional Officers failed to complete about half of the required inmate-monitoring rounds in the
housing units that hold vulnerable inmates at the highest medical and mental health care levels, many of
whom are at increased risk for medical-related emergencies, self-harm, and suicide. Second, we found
multiple deficiencies in the institution’s radio system, including “dead zones” where employee radios do not
receive radio signals, namely in the hospital areas, and some radios were beyond their serviceable dates.
Nonworking radios impede employees’ response to medical and nonmedical emergencies, thus
jeopardizing inmates’ and employees’ safety. Regarding inmate programming, because of staffing
shortages, many psychology and education-based programs offered to inmates have large waitlists, with
over 100 inmates, and only 1 skills-based vocational program with 10 inmates enrolled and 70 inmates on
the waitlist was offered to inmates at the time of our inspection. Additionally, due to lack of staffing, the
FMC Devens LifeSkills Laboratory, a space designed for inmates with serious mental illnesses to practice
routine skills—which received $150,000 in FIRST STEP Act (FSA) funds—had yet to be used for programming
since its construction 3 years prior to our inspection. Lastly, FMC Devens had serious infrastructure issues
with many unfunded repair projects, including roof repairs and replacement of cooling and heating systems,
which it estimated would cost $15 million. The OIG noted the effects of water intrusion throughout the
institution, including within housing units, employee offices, and rooms with optometry and dialysis
equipment. If repairs are not made soon, equipment and infrastructure failures could exacerbate repair
costs and negatively affect inmates’ conditions of confinement.
ii
C.Agnello SE 0016
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 20 of 569 PageID #:
214
Report Highlights
We found serious issues with FMC Devens’s provision of healthcare to its inmates:
• Significant and widespread staffing shortages in the Health Services Department compromise
FMC Devens’s ability to provide adequate healthcare to inmates.
• Concerning healthcare practices include:
potentially dangerous practices related to the distribution of buprenorphine and naloxone;
a backlog of outside medical visits that had yet to be scheduled and a discrepancy in the
number of pending inmate medical records;
inconsistent access to medical care for routine conditions;
Inmate inconsistent routine screening of inmates over age 50 for preventive healthcare or cognitive
Healthcare impairment;
not all inmates with a diabetes diagnosis being tested within required timeframes;
not all healthcare provider credential files being verified according to BOP policy;
improper placement of some inmates in the MDU; and
some medical inmate companions not meeting the BOP’s eligibility criteria and some performing
duties outside the scope of a medical inmate companion, which is prohibited by the BOP.
Two safety and security issues affect the safety of institution operations:
• Correctional Officers did not complete all inmate-monitoring rounds as required by policy, leaving
vulnerable inmates unobserved for multiple hours each night.
Safety and • Employee radios did not receive a signal in some parts of the institution, namely the hospital and
Security areas below ground, and radios were beyond their serviceable dates, rendering many radios
unrepairable.
Staffing shortages limit opportunities for inmates to participate in programs designed to prepare
them for successful reentry:
• Psychology Services Department employees must prioritize programming for inmates with higher
mental health care levels, leaving inmates with lower mental health care levels with a lack of
programming and resources.
• Shortages of Education Department employees limited FMC Devens from offering General
Inmate Education Diploma courses, the Commercial Driver’s License program at the Camp, and the
Programming Certified Nursing Assistant program at the FMC.
• In fiscal year (FY) 2021, FMC Devens received $150,000 in FSA funds as one of three BOP
institutions selected to pilot the initial implementation of the FSA LifeSkills Laboratory program.
However, as of FY 2025, FMC Devens had yet to enroll inmates in this program.
FMC Devens has several unfunded major infrastructure and equipment repair projects that present
safety and security issues:
• Many of the institution’s systems are approaching the end of their projected lifespan, and the
roofs need repair.
Infrastructure
• Officials estimated the cost of this work to be $15 million.
iii
C.Agnello SE 0017
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 21 of 569 PageID #:
215
Table of Contents
Introduction .............................................................................................................................................................. 1
FMC Devens ...............................................................................................................................................................2
FMC Devens Medical and Mental Health Missions ...............................................................................................2
Inspection Results .................................................................................................................................................... 7
Staffing Challenges ....................................................................................................................................................7
Inmate Healthcare .................................................................................................................................................. 15
Safety and Security................................................................................................................................................. 25
Inmate Programming............................................................................................................................................. 27
Physical Conditions and Infrastructure ............................................................................................................... 30
Conclusion and Recommendations ...................................................................................................................... 35
Conclusion ............................................................................................................................................................... 35
Recommendations ................................................................................................................................................. 37
Appendix 1: Purpose, Scope, and Methodology ................................................................................................. 39
Standards ................................................................................................................................................................ 39
Purpose and Scope ................................................................................................................................................ 39
Inspection Methodology........................................................................................................................................ 39
Appendix 2: DOJ OIG and Other Oversight Agency Related Work ..................................................................... 41
Appendix 3: BOP Policies and Clinical Guidance Cited ....................................................................................... 43
Appendix 4: The BOP’s Response to the Draft Report ........................................................................................ 45
Appendix 5: OIG Analysis of the BOP’s Response ............................................................................................... 57
iv
C.Agnello SE 0018
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 22 of 569 PageID #:
216
Introduction
This report details the results of the U.S. Department of Justice (DOJ) Office of the Inspector General’s (OIG)
unannounced inspection of a Federal Bureau of Prisons (BOP) prison, Federal Medical Center (FMC) Devens,
located in the town of Ayer, Massachusetts, which is
approximately 39 miles west of Boston. FMC
Devens is within the BOP’s Northeast Region and is
Federal Prison Oversight Act
composed of two facilities, an administrative-
security medical center, housing inmates with On July 25, 2024, the Federal Prison Oversight Act (FPOA)
serious medical or mental health conditions, and an was signed into law. The FPOA requires the OIG to
adjacent minimum-security prison camp. In this conduct periodic inspections of BOP facilities based on
the OIG’s assessment of risk factors at BOP
report, we refer to the overall institution as “FMC
facilities. Prior to the FPOA’s enactment, the OIG
Devens,” the administrative-security prison as the
identified FMC Devens for inspection based on our
“FMC,” and the minimum-security prison camp as assessment of risk factors at the institution. Consistent
the “Camp.” with the FPOA’s requirements, we are reporting the
findings from our inspection of FMC Devens, and our
recommendations to the BOP, publicly and to the U.S.
This is the fifth report of an unannounced Congress.
inspection the OIG has conducted of a BOP
Source: Federal Prison Oversight Act, Pub. L. No. 118-71,
institution pursuant to its on-site inspections
138 Stat. 1492 (2024) (codified at 5 U.S.C. § 101 (note))
program. We previously issued separate reports
detailing our inspections of Federal Correctional
Institution (FCI) Waseca and FCI Tallahassee, both of
which housed female inmates. The former is in the
BOP’s North Central Region; the latter is in the
BOP’s Southeast Region. We also issued our report
on the inspection of FCI Sheridan, an institution
housing male inmates, which is in the BOP’s
Western Region. Most recently, we issued a report
on the inspection of FCI Lewisburg, an institution
housing male inmates in the BOP’s Northeast
Region. We selected FMC Devens as the site of our
fifth inspection to better understand and assess the
conditions of confinement for male inmates at a
Federal Medical Center.
FMC Devens Main Entrance
The OIG conducted its inspection of FMC Devens
Source: OIG, April 2024
between Monday, April 22, and Friday, April 26,
2024. While on site, we made physical
observations; interviewed employees and inmates;
reviewed security camera footage; and collected records related to inmate medical and mental healthcare,
inmate programming and education, institution staffing levels, conditions of confinement, and allegations of
employee and inmate misconduct. We also made follow-up requests for additional data, interviews, and
documents from the institution and the BOP’s Central Office, which we used to further inform our
inspection (see Appendix 1 for more details on the methodology).
1
C.Agnello SE 0019
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 23 of 569 PageID #:
217
FMC Devens
FMC Devens: Institution Profile
As of April 22, 2024, the FMC housed
861 inmates, about 76 percent of its physical Location
capacity of 1,137. It has six general population Ayer, MA
housing units, four mental health units, four
medical (hospital) units, and one Special Medical Care Level
Housing Unit (SHU). The general population 4 of 4
housing units are a combination of cells and
open-concept living spaces with inmate bunk Mental Health Care Level
beds and communal areas for bathrooms, 4 of 4
showers, and recreation. The mental health
units vary based on the mental healthcare Employees
needs of inmates. Generally, the mental Total Positions: 533
health units have single- and double- On Board: 432
occupancy cells containing single beds with a 101 Vacancies
sink and toilet. Showers may be located in
FMC Camp
single-occupancy cells or in communal
Population Population
bathroom areas. Similarly, the hospital units
Physical Capacity: Physical Capacity:
vary based on the medical care needs of
inmates. Within the medical housing units, 1,137 122
there are inmate patient beds separated by Actual Headcount: Actual Headcount:
curtains or walls, as well as inmate patient
861 80
rooms containing up to four beds. The SHU
~76% Capacity ~66% Capacity
houses inmates who need to be separated
from the general population, and it generally Security Level Security Level
contains double-occupancy cells with a Administrative Minimum
shower, sink, and toilet. Inmates remain
locked in SHU cells except when they are Housing Units Housing Units
escorted to recreation areas, medical 6 General Population 1 Building with Open-
appointments, visitation, and the law library. Units, 4 Mental Health Concept Living Spaces
Units, 4 Medical Units,
and 1 SHU
At the time of our inspection, the Camp housed
80 inmates, approximately 66 percent of its Employee totals are as of April 21, 2024. Inmate population
physical capacity of 122. Camp inmates live in totals are as of April 22, 2024.
one housing building that has open-concept
Source: FMC Devens documentation
living spaces. Each living space contains bays
with inmate bunk beds, as well as communal
areas for bathrooms, showers, and recreation.
FMC Devens Medical and Mental Health Missions
FMC Devens is one of seven BOP Federal Medical Centers that house inmates of all medical and mental
health care levels. Similar to other BOP institutions, FMC Devens provides 24-hour, 7-day medical services,
such as suicide prevention, and individualized treatment plans and medication. As a Federal Medical
Center, FMC Devens also has several ongoing medical and mental health missions to provide specialized
inmate patient care, such as inpatient services, dialysis treatment, behavioral monitoring, and specialized
2
C.Agnello SE 0020
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 24 of 569 PageID #:
218
psychiatric care to inmates with the most severe needs. Inmate medical and mental health care levels are
determined by the inmate’s medical and mental health needs and are based primarily on chronicity,
complexity, intensity, and frequency of interventions and services that are required, as well as an inmate’s
functional capability (see Table 1 below). Medical and mental health care levels are not synonymous and
can increase or decrease over time based on the inmate’s medical and mental health conditions. For
example, an inmate could have cancer that is in partial remission (Medical Health Care Level 3) and show no
significant level of functional mental impairment (Mental Health Care Level 1).
Table 1
BOP Medical and Mental Health Care Levels
Medical Health Care Level Descriptions and Examples Mental Health Care Level Descriptions
Inmates are less than 70 years of age and are generally
Inmates show no significant level of functional
healthy; they may have limited medical needs that can be
1 easily managed by clinicians every 6–12 months.
Mild asthma, diet-controlled diabetes, well-controlled
impairment associated with mental illness and
demonstrate no need for regular mental
health interventions.
hypertension, etc.
Inmates require routine outpatient mental
Inmates require clinical evaluations monthly to every
2
healthcare on an ongoing basis and/or brief,
6 months; their medical conditions can be managed through
crisis-oriented mental healthcare of significant
routine, regularly scheduled appointments.
intensity (e.g., placement on suicide watch or
Medication-controlled diabetes, epilepsy, or emphysema
behavioral observation status).
Inmates have complex, and usually chronic, medical
conditions and require frequent clinical contact to maintain
control or stability of their conditions or to prevent Inmates require enhanced outpatient mental
3 hospitalizations or complications; inmates may require
assistance with some activities of daily living that can be
accomplished with inmate companions.a
healthcare (i.e., weekly mental health
interventions) or residential mental healthcare
(i.e., placement in a residential Psychology
Cancer in partial remission, advanced human Treatment Program).
immunodeficiency virus disease, severe mental illnesses, or
end-stage liver disease
Inmates have acute medical or chronic mental health
Inmates require acute care in a psychiatric
conditions, may be severely impaired, and may require 24-
4 hour skilled nursing care or nursing assistance.
Cancer on active treatment, dialysis, quadriplegia, stroke,
hospital, are gravely disabled, and cannot
function in general population in an enhanced
outpatient environment.
major surgical treatment
a An inmate companion is part of the inmate work program and receives specialized training to assist and support
other inmates unable to independently perform one or more activities of daily living.
Note: Conditions generally classified as serious mental illnesses include schizophrenia spectrum and other psychotic
disorders, bipolar and related disorders, major depressive disorder, anxiety disorders, obsessive-compulsive and
related disorders, trauma and stressor-related disorders, intellectual disabilities and autism spectrum disorders,
major neurocognitive disorders, personality disorders.
Source: BOP Care Level Classification for Medical and Mental Health Conditions or Disabilities, May 2019
3
C.Agnello SE 0021
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 25 of 569 PageID #:
219
As stated above, inmates can be assigned a medical care level independent of their mental health care level,
and vice versa, as the two are not always synonymous. At the time of our inspection, FMC Devens had the
inmate composition depicted in Figure 1 below.
Figure 1
Percentages of FMC Devens Inmates by Medical Care Level and Mental Health Care Level, April 2024
13% (122)
Care Level 4
18% (171)
2% (20)
Care Level 3
13% (127)
6% (56)
Care Level 2
26% (241)
79% (743)
Care Level 1
43% (402)
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
Mental Health Care Level Medical Care Level
Source: FMC Devens documentation
As a Federal Medical Center, FMC Devens has several ongoing medical missions to provide specialized
inmate patient care:
• Inpatient Services: The inpatient medical unit has a 12-bed capacity, including 1 airborne isolation
room. This unit provides health and personal care services to chronically ill, aged, physically
disabled, or developmentally disabled inmates on a long-term basis, including 24-hour, 7-day
nursing care. Additionally, this unit may provide short-term care for inmate patients who require
medical care beyond the capabilities of the outpatient clinic but do not meet requirements for
transfer to an outside hospital.
• Outpatient Services: FMC Devens is responsible for addressing urgent care needs, as they arise, for
all inmates in the institution, as well as for providing routine care through clinics and separate
preventive health services based on policy requirements, risk profiles, recommended screening
intervals, and results of screening tests. Such services may include physical examinations, infectious
disease screening, cancer screening, chronic disease screening, and immunizations.
4
C.Agnello SE 0022
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 26 of 569 PageID #:
220
• Dialysis Unit: The Dialysis Treatment Center provides treatment for inmates with end-stage renal
failure. The BOP has only four institutions with a dialysis unit: FMC Devens, FMC Butner, FMC
Carswell, and U.S. Medical Center for Federal Prisoners Springfield.
• Transplant Coordination Services: FMC Devens provides access to organ transplants, including liver
and kidney transplants, through its comprehensive medical contract with a community transplant
center. FMC Devens was the first BOP institution to provide its inmates donor transplant services.
• Rehabilitation Services: The Physical Therapy Department provides a full range of services for
inmates referred with orthopedic, neurologic, and general medical conditions.
• Memory Disorder Unit (MDU): The MDU provides 24-hour nursing care to inmates who have
dementia. FMC Devens maintains the only MDU within the BOP. 1
FMC Devens also has several primary mental health missions:
• Forensic Evaluation Site: In accordance with 18 U.S.C. §§ 4241–4248, FMC Devens conducts court-
ordered psychological evaluations and direct psychological care for defendants and inmates
referred from all parts of the United States. Specifically, psychological evaluations can be conducted
to assess and restore competency for criminal proceedings; weigh criminal responsibility in light of
mitigating and aggravating mental or behavioral disorders; and monitor persons found to be
dangerous, sexually or otherwise.
• Restorative Care: FMC Devens provides specialized, limited inpatient evaluation and psychiatric
care—including the involuntary administration of psychiatric medication—to pretrial detainees who
have been judged incompetent to stand trial. The limit on initial commitment for a pretrial detainee
who has been court ordered to undergo restorative care is not to exceed 4 months; however,
additional time can be ordered if it is likely that the individual will be restored to competency.
• Civil Commitments: FMC Devens provides inpatient psychiatric care for pretrial and sentenced
inmates who have been civilly committed due to incompetence, assignment as sexually dangerous
under the Sex Offender Registration and Notification Act, or through a determination by the
institution’s Risk Assessment Panel, which reviews all mentally ill inmates (convicted or not guilty by
reason of insanity) annually and prior to their release. 2
• Serious Mental Illness: FMC Devens provides continuous care for inmates with severe mental
illnesses, such as schizophrenia spectrum disorders, bipolar disorder, major depressive disorder,
1 Dementia is a condition characterized by the loss of cognitive function—the ability to think, remember, or reason—to
the extent that it interferes with memory, language skills, visual perception, problem solving, self-management, and
basic activities of daily living. See National Institute of Neurological Disorders and Stroke, “Dementias,”
www.ninds.nih.gov/health-information/disorders/dementias?search-term=dementia#toc-the-basics-of-dementia-and-
cognitive-impairment (accessed October 2, 2024).
2 See Appendix 3 (Certification and Civil Commitment of Sexually Dangerous Persons).
5
C.Agnello SE 0023
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 27 of 569 PageID #:
221
and other psychotic disorders. Inmates experiencing serious mental illness are housed in either the
Secure Mental Health Unit (SMHU) or a transitional Mental Health Unit. Inmates may be admitted to
the SMHU if they have a severe mental illness and a significant history of violence or are at
heightened risk for suicide. The SMHU has 24-hour, 7-day care and offers treatment plans that
include interventions and services from various departments at FMC Devens, with the goal of
moving SMHU inmates to a transitional Mental Health Unit. The transitional Mental Health Units are
considered step-down units from the SMHU and offer intermediate levels of care for inmates with
serious mental illness. The goal of the transitional Mental Health Units is to minimize relapse and to
prepare inmates for integration into general population housing units and society at large.
• Sex Offender Management Program (SOMP) and Residential Sex Offender Treatment Program
(SOTP-R): The SOMP is a moderate-intensity management program designed for low-to-moderate-
risk sexual offenders. The program includes psychoeducational groups and individual
psychotherapy. Within the SOMP, FMC Devens facilitates the SOTP-R, a voluntary, high-intensity
program designed for high-risk sexual offenders in a residential treatment unit. The program
includes cognitive-behavioral based psychotherapy groups.
• Substance Abuse Treatment: FMC Devens provides a Non-Residential Drug Abuse Program that is a
moderate-intensity cognitive-behavioral treatment program. FMC Devens also provides Medication
Assisted Treatment, which is the use of medication in combination with drug education classes,
counseling, and/or behavioral therapy to treat inmates diagnosed with Opioid Use Disorder.
In addition to the mental health missions at FMC Devens, the institution participates in a predoctoral
internship program, accredited by the American Psychological Association, through which students assist
with the mental healthcare of inmates at the institution while completing their doctorate.
6
C.Agnello SE 0024
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 28 of 569 PageID #:
222
Inspection Results
Staffing Challenges
As described extensively in previous Figure 2
OIG oversight products, staffing
shortages and employee allocations are
among the chief and long-standing FMC Devens Staffing Level Overview
operational challenges facing the BOP
enterprise-wide. Our inspection of FMC
Filled
Devens found significant staffing Vacant
shortages at the institution, as well as 500
101
substantial disparities in BOP estimates
of the staffing levels necessary for the
institution to execute its missions 400
successfully. FMC Devens employees
noted that many of its existing positions
were vacant, which they believed 300
hampered their ability to achieve
effective operations. As described in
432
greater detail below, FMC Devens 200
40
Executive Leadership’s perspective
about additional staffing needs is in 36
contrast with estimates developed by 100
161
an outside contractor hired by the BOP 113
to calculate appropriate staffing levels 13
0 20
for each institution through a recently
deployed staffing projection tool. Overall (81%) Correctional Health Psychology
Services (80%) Services (76%) Services (61%)
At the time of our inspection, FMC Notes: Here and throughout the report, “Health Services” includes BOP
Devens had a total of 533 positions Health Services employees and employees of the U.S. Public Health
composed of 506 BOP positions Service, a branch of the uniformed services that supports public health
authorized specifically for FMC Devens and helps fill health services roles within federal agencies and
in the Departments of Correctional programs. “Psychology Services” includes Psychology Services
Services, Health Services, Psychology employees, employees from the Drug Abuse Program, and employees
Services, and others; 24 positions from the Sex Offender Management Program.
supported through the U.S. Public Source: FMC Devens staffing data as of April 2024
Health Service; and 3 supplemental
staffing allocations from DOJ. We found
that 81 percent (432 of 533) of FMC Devens’ total positions were filled. Specifically, there were 40 vacancies
in the Correctional Services Department, 36 vacancies in the Health Services Department, and 13 vacancies
7
C.Agnello SE 0025
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 29 of 569 PageID #:
223
in the Psychology Services Department. 3 To alleviate staffing shortages, the BOP spent approximately
$4 million on retention bonuses; $176,000 on recruitment incentives; and $60,000 on student loan
repayments at FMC Devens. Yet, we found these incentives to be somewhat ineffective due to the high cost
of living and better paying jobs across the state of Massachusetts, which some employees left FMC Devens
to attain. BOP Director Colette Peters testified before the U.S. House of Representatives’ Subcommittee on
Crime and Federal Government Surveillance that a Correctional Officer left their position at FMC Devens for
a position with a better wage at a local grocery store. According to the BOP and the Department of Justice,
physicians at FMC Devens earn approximately $282,480 per year whereas a physician at a nearby hospital
emergency department earns about $415,300. Similarly, mid-level practitioners at FMC Devens earn a
salary between $72,182 and $123,528 whereas mid-level practitioners at a nearby hospital earn an average
salary of $141,120. 4 Additionally, we found that the annual median wage for Correctional Officers in state
and local prisons across the state of Massachusetts was $78,810 and the annual median wage for nurses
was $99,730. These discrepancies illustrate that positions at FMC Devens are not competitive within the
surrounding area, which could hinder FMC Devens’s ability to retain and hire qualified employees. 5
We also found that upcoming retirements of employees may exacerbate FMC Devens’s staffing crisis. At the
time of our inspection, at least 70 employees were eligible for retirement and an additional 11 employees
were scheduled to retire by the end of calendar year 2024. Of the 70 employees eligible to retire, 41
percent (29) worked in the Correctional Services Department.
Relevant Prior OIG Work and Related Recommendations: BOP Staffing Levels
A 2021 Government Accountability Office (GAO) report recommended that the BOP develop and implement a reliable
method for calculating staffing levels at BOP institutions. The DOJ OIG made a similar recommendation in a 2023
report examining the BOP’s strategies to identify, communicate, and remedy operational issues. In response to these
recommendations, the BOP hired an outside contractor in 2021 to help it calculate staffing levels for each BOP
institution, using a staffing projection tool.
Both the GAO’s and the OIG’s recommendations remain open, but we note that the BOP has made progress in
developing the staffing projection tool, which we discuss in greater detail in the sections below.
See Appendix 2, Items V and XIV, for more information about these reports.
3 We report these vacancies as reflected on the BOP’s internal staffing report; however, the BOP’s count of vacancies
differs. The BOP considers five Health Services Department positions to be “aligned” under the Psychology Services
Department.
4 This data is included in a document submitted by DOJ to the U.S. Senate Committee on the Judiciary on November 7,
2024, titled “A Funding Proposal to Address Critical Safety Needs Across the Federal Prison System.”
5 At the time of our inspection, at FMC Devens the entry-level salaries were $55,138 for Correctional Officers and
$62,672 for nurses. After receiving a draft of this report, the BOP noted that not all Correctional Officers and nurses
were paid at the minimum entry-level rate. In addition, the BOP told us that it submitted two nationwide Special Salary
Rate requests to the U.S. Office of Personnel Management for Correctional Officer and nursing positions in an effort to
offer more competitive salaries. The BOP discusses these Special Salary Rate requests in its response to the draft report
(Appendix 4), and the OIG mentions the requests in its analysis of the BOP’s response (Appendix 5).
8
C.Agnello SE 0026
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 30 of 569 PageID #:
224
Correctional Services Staffing Shortages
Staffing shortages at FMC Devens have particularly affected the Correctional Services Department, which is
composed primarily of Correctional Officer positions. Correctional Officers are vital to the safety and
security of the institution, as they are responsible for providing round-the-clock supervision of inmates.
Specifically, FMC Devens had only 80 percent of its Correctional Services positions filled at the time of our
inspection (see Figure 2 above). To compensate for vacancies in these critical positions, institution
management has adopted two stopgap measures used widely across the BOP to maintain coverage of
correctional posts: (1) mandated and voluntary overtime and (2) temporary assignment of non-Correctional
Officer personnel into Correctional Officer positions, a practice known as augmentation. 6 Through these
measures, FMC Devens employees performed about 98,000 hours of work covering Correctional Officer
posts—equivalent to approximately 47 full-time positions—from January 2023 through April 2024. The BOP
noted that the majority of the 98,000 hours includes the use of an FMC Devens mutual agreement whereby
Correctional Officers can earn and utilize compensatory time within their 40-hour work week. 7
Even if the FMC Devens Correctional Services Department filled all of its vacancies, we question whether it
would be able to appropriately staff the FMC and the Camp without the continued use of overtime and/or
augmentation. At the time of our inspection, 161 of 201 Correctional Services Department positions had
been filled, which amounts to 40 vacancies. However, in the year prior to our inspection, FMC Devens
management used overtime, augmentation, and compensatory time to fill the equivalent of approximately
47 of these full-time positions. 8 Given that the extent of staffing gaps the institution covered through
overtime, augmentation, and compensatory time represents 7 positions greater than its official number of
vacancies less than a year later, we believe that the 201 positions officially allocated to the Correctional
Services Department may be too low.
When we discussed staffing levels with the FMC Devens Warden, he believed that 201 authorized positions
for the Correctional Services Department was sufficient. However, this figure differs significantly from the
calculation produced by the BOP contractor’s staffing projection tool, which as of July 2024 projected that
FMC Devens needed only 189 authorized positions in its Correctional Services Department. Moreover, the
staffing projection tool estimate of 189 employees is below the number of Correctional Services employees
6 The OIG described the BOP’s use of mandatory overtime and augmentation in our inspection reports of FCI Sheridan
and FCI Lewisburg and in broader OIG work on BOP inmate deaths in custody. In the latter report, we found that all
three BOP sites we visited (U.S. Penitentiary Thomson, Federal Transfer Center Oklahoma City, and Federal Correctional
Complex Hazelton) used mandatory overtime to compensate for staffing shortages. See Appendix 2, Items III, IV, and VI,
for more information on these reports and Item VII for our 2020 Management Advisory Memorandum on the BOP’s use
of overtime in 2019.
7 After receiving a draft of this report, the BOP told us that overtime, augmentation, and compensatory time do not
directly correlate to workforce needs.
8 The U.S. Office of Management and Budget calculates the total number of work and leave hours that a full-time
equivalent employee records during a year at 2,080. Because those 2,080 hours include annual, sick, and other leave
that an employee may use during the year, our calculation understates the number of full-time employees that would
be needed to cover those 98,000 hours of overtime. However, because annual leave granted to an employee each year
is based on the employee’s seniority, it would be impracticable for us to calculate with precision the number of full-time
equivalent employees that the 98,000 hours of overtime represents.
See past OIG work on the BOP’s use of overtime at Appendix 2, Item VII.
9
C.Agnello SE 0027
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 31 of 569 PageID #:
225
currently on board combined with the OIG’s calculation of the amount of overtime and augmentation FMC
Devens employees worked to cover Correctional Services needs. Table 2 below depicts the differences in
current and projected staffing needs in the Correctional Services Department.
Table 2
FMC Devens Correctional Services Department Position Totals and Projected Needs, April 2024
Filled Positions Plus
Positions Filled via Estimate of Necessary Staffing Projection Tool
Filled Authorized
Overtime, Compensatory Positions Made by FMC Estimate of Necessary
Positions Positions
Time Earned, or Devens’s Warden Positions
Augmentation
161 201 208 (161+47) 201 189
Notes: The OIG calculated positions filled via overtime for FMC Devens’s Correctional Services Department by dividing
employee overtime, compensatory time, and augmentation hours worked in Correctional Services (approximately
98,000) by the total number of work and leave hours (2,080) the U.S. Office of Management and Budget calculates that a
full-time equivalent employee records during a year. Positions filled via overtime numbers are rounded.
Sources: FMC Devens staffing data, FMC Devens Executive Leadership, and the BOP contractor’s staffing projection tool
Relevant Prior OIG Work and Related Recommendations: Correctional Officer Shortages
Affecting Safety and Security
The OIG’s June 2023 report on its investigation and review of the BOP’s custody, care, and supervision of Jeffrey
Epstein at Metropolitan Correctional Center New York found that staffing deficiencies at the institution contributed to
the failure of its employees to perform inmate-monitoring rounds during the evening of Epstein’s death. A 2024 OIG
report on inmate deaths in custody also found that the failure to appropriately complete inmate-monitoring rounds
was a factor contributing to 86 BOP inmate deaths, including Epstein’s, between 2014 and 2021.
To address the effects of staffing shortages on institution safety, in the Epstein report the OIG recommended that the
BOP continue to develop and implement plans to address staffing shortages at its prisons. As of the publication of
this report on FMC Devens, this recommendation remains open.
See Appendix 2, Items VI and VIII, for more information about these reports.
Health Services Staffing Shortages
At the time of our inspection, FMC Devens’s Health Services Department was staffed at 76 percent, with 113
of 149 positions filled. However, this low staffing percentage does not reflect the true staffing crisis the
Health Services Department is experiencing. We provide examples below:
• Two of the institution’s six physicians were on extended leave without pay, and three physician
positions were vacant, leaving one physician and the Clinical Director (who is also a physician) to
10
C.Agnello SE 0028
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 32 of 569 PageID #:
226
manage the care of the entire inmate population. The Clinical Director retired in June 2024; the
position remained vacant as of October 5, 2024, leaving FMC Devens without this critical medical
role filled and only one physician at the institution.
• The Chief Pharmacist, the Chief Psychiatrist, and the Director of Nursing have also retired since our
inspection; these positions remained vacant as of October 5, 2024. Further, both the Chief Dental
Officer and Deputy Chief Psychologist positions were vacant.
• Other vacancies at the time of our inspection include 24 percent of nurse positions (10 of 42 filled)
and 45 percent of pharmacist positions (5 of 11 filled).
• During calendar year 2024, eight additional employees, including medical records employees,
technicians, and nurses, became eligible to retire.
Yet, despite the substantial number of vacancies, some employees in the FMC Devens Health Services
Department are required to participate in augmentation. 9 Of the 113 employees in the department,
38 percent (43) are required to participate in augmentation to Correctional Officer posts or nursing posts.
At the time of our inspection, 33 employees, including administrative employees, health information
technicians, dietitians, and laboratory employees, were augmented to Correctional Officer posts and
10 Health Services Department employees with a nursing background were augmented to nursing posts.
We believe that FMC Devens’s Health Services Department is in a staffing crisis due to the overall staffing
numbers and the augmentation requirements of employees within this department. We are concerned that
the staffing crisis could limit medical services provided to inmates and negatively affect the institution’s
ability to care for inmates, including inmates who may have been transferred to FMC Devens expressly for
specific medical programs, such as dialysis, transplant, or the Memory Disorder Unit (MDU).
Illustrative of our concerns, due to the systemic shortage of nurses and physical therapists, FMC Devens had to
limit the transfers of inmates from other BOP institutions for placement in the MDU or for orthopedic care. In
January 2024, the FMC Devens Warden requested a pause in inmate admissions to the MDU until October 25,
2024; the request was granted in April 2024, during our inspection. As stated in the Medical and Mental
Health Missions section of this report, the MDU at FMC Devens is the only MDU within the BOP to provide the
specialized care those inmates need. Similarly, FMC Devens paused accepting new orthopedic cases from
March 13 until December 3, 2024, because only one physical therapist and one occupational therapist were
treating the large inmate population with orthopedic needs. According to the Chief Physical Therapist, the
institution had been operating with only one physical therapist since August 2023 and there was a growing
waitlist of inmates needing physical therapy services. We believe that the pause in accepting inmates from
other institutions into the MDU and for orthopedic care could negatively affect the continuity of inmate care;
could require inmates to stay at institutions without necessary memory disorder or orthopedic care, which
9 After receiving a draft of this report, the BOP told us that Health Services employees who provide direct patient care
are not augmented to Correctional Officer posts. However, some FMC Devens employees, including mental health and
medical social workers, who provide one-on-one care for inmates, were augmented to Correctional Officer posts during
the prior year. FMC Devens Executive Leadership explained that the Health Services and Correctional Services
Departments collaborate to ensure that augmentation does not result in a Health Services Department closure or a
delay in medical services; specific employees may be exempt from augmentation.
11
C.Agnello SE 0029
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 33 of 569 PageID #:
227
may exacerbate these conditions; and could lead to costly placement in community care facilities if proper
care is not available within the BOP.
Further, on May 10, 2024, FMC Devens requested a temporary pause in accepting Medical Care Level 4
inmates, who require advanced medical care and daily living assistance, from other BOP institutions due to
the Health Services Department staffing crisis. According to the Warden, any more inmates requiring
advanced medical care and daily living assistance without adequate employee coverage would leave the
already high-risk inmate population at a greater risk of medical-related emergencies. On June 5, the BOP’s
Central Office reviewed and approved FMC Devens’s request, granting a moratorium for Medical Care
Level 4 inmates who require assistance with activities of daily living until December 3, 2024. We find this
pause in accepting Medical Care Level 4 inmates concerning because restricting the transfer of inmates with
advanced medical care needs to a Federal Medical Center could negatively affect the health and care of
those inmates. Those inmates may be required to remain at an institution that lacks advanced medical
care, which could exacerbate an inmate’s medical condition and require the BOP to incur significant costs
for outside care.
In addition to their concern with the institution’s Correctional Services staffing levels, Executive Leadership
expressed concern about their ability to meet mission needs with the current medical and mental
healthcare staffing levels. They also expressed concerns related to their ability to hire qualified medical and
mental health employees, noting that the state of Massachusetts has an abundance of medical and mental
health employment opportunities and that those positions pay more than FMC Devens can. They believed
that more competitive pay would help them recruit and hire qualified candidates, and, in order to address
FMC Devens’s responsibilities as a Federal Medical Center, the Warden reported that FMC Devens would
need approximately 250 employees in the Health Services Department. In addition, Health Services
Department employees told us that morale within the department is low, due to the low staffing levels, as
the department struggles to manage its daily responsibilities. Low morale within the department may cause
employees to leave FMC Devens to work elsewhere, which would exacerbate the effects of low staffing.
In contrast to the reduced Correctional Officer staffing estimate produced by the BOP contractor’s staffing
projection tool, discussed above, the tool recommended increasing the number of positions for the Health
Services Department. The tool recommended 304 positions for the Health Services Department, a far
greater number than Institution management told us they could use. Specifically, although FMC Devens’s
Executive Leadership believed that they needed far more than the current 149 positions, they said that the
institution did not have the space or equipment to accommodate 304 employees and that it would be
difficult to fill over 100 vacancies. Table 3 below shows the differences in current and projected staffing
needs for the Health Services Department.
12
C.Agnello SE 0030
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 34 of 569 PageID #:
228
Table 3
FMC Devens Health Services Department Position Totals and Projected Needs, April 2024
Actual Filled Positions and
Positions Covered by Estimate of Necessary Staffing Projection Tool
Filled Authorized
Overtime, Compensatory Positions Made by FMC Estimate of Necessary
Positions Positions
Time Earned, and Devens’s Warden Positions
Augmentation
113 149 N/A 250 304
Notes: We included one supplemental staffing allocation in the Health Services Department authorized positions.
Although some Health Services employees are eligible to earn compensatory time and overtime, not all Health Services
employees are augmented to Correctional Officer posts; therefore, the OIG did not include in this calculation positions
filled via compensatory time, overtime, and augmentation.
Sources: FMC Devens staffing data, FMC Devens Executive Leadership, and the BOP contractor’s staffing projection tool
When we discussed discrepancies between FMC Devens’s and the staffing projection tool’s estimates with the
BOP’s Assistant Director for the Human Resource Management Division at Central Office and the contract
employees who developed the tool, they explained that the staffing projection tool includes a variety of
factors in its algorithm to generate staffing estimates for institutions and that those estimates reflect the
needs of an institution under ideal circumstances. However, the contract employees told us that the existing
infrastructure within the institution and its square footage were not considered when the tool recommended
increasing the number of positions within FMC Devens’s Health Services Department.
Relevant Prior OIG Work: Medical Personnel Shortages
Medical personnel shortages have been a long-standing challenge for the BOP. In a March 2016 report, we found
that medical personnel positions were filled at only 83 percent across the BOP. As we observed during our inspection
of FMC Devens, the BOP’s medical personnel shortages persist. According to a September 2023 Pandemic Response
and Accountability Committee report to which the DOJ OIG contributed, at that time the BOP’s medical personnel
shortage stood at 69 percent. That report detailed a variety of contributing factors, including noncompetitive pay,
limited career advancement opportunities, and the additional stressors and responsibilities associated with working
in a correctional setting compared to those associated with working in the community. The report also detailed how
these shortages contributed to decreases in patient satisfaction and delays in routine and preventive care during the
coronavirus disease 2019 pandemic. As noted previously in this report, the OIG’s Epstein report recommended that
the BOP continue to develop and implement plans to address staffing shortages at its prisons, including medical
staffing shortages, and, as of the publication of this report on FMC Devens, that recommendation remains open.
See Appendix 2, Items VIII, XI, and XII, for more information about these reports.
Psychology Services Staffing Shortages
At the time of our inspection, FMC Devens’s Psychology Services Department was staffed at only 61 percent
(20 filled positions out of 33), with vacancies including the only authorized staff psychologist; both advanced
13
C.Agnello SE 0031
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 35 of 569 PageID #:
229
care psychologists; two sex offender program psychologists; and all three specialty treatment program
specialists, who provide individual and group therapy to inmates. Because BOP policy requires the
institution to prioritize the treatment of inmates with higher mental health care levels over the needs of
inmates with lower mental health care levels, FMC Devens’s Psychology Services Department devotes much
of its staff resources to its varied inmate specialty groups like the Sex Offender Treatment Program and
inmates with serious mental illness, as the Medical and Mental Health Missions section of this report
described. Consequently, Psychology Services Department staffing shortages exacerbate the issue of
limited treatment, such as individual or group treatment and psychology-led programming, available to
inmates without a serious mental disorder. In the Inmate Programming section of this report, we further
discuss how staffing issues affect inmate programming.
Additionally, at the time of our inspection, only one employee was overseeing both the Drug Abuse Program
and the Medication Assisted Treatment (MAT) program. Psychology Services Department employees told us
that, without a MAT-focused psychologist, their ability to screen inmates and begin MAT programming was
limited. Similarly, at the time of our inspection, while both Forensics Unit psychologist positions were filled,
as of June 2024, one of the Forensics Unit psychologists went on extended leave, leaving the institution with
only one Forensics Unit psychologist. Due to the volume and demands of the Forensics Unit psychologists’
caseloads at FMC Devens, during the summer of 2024 the BOP’s Central Office dispatched temporary
evaluators to assist with the caseloads and prepare for incoming inmates who require forensic psychologist
review. Psychology Services Department management expressed that, while these efforts helped the
institution avoid delays in completing forensic evaluations, they were concerned that the day-to-day care
and oversight of the 52 forensic evaluation inmates at FMC Devens fell on one Forensics Unit psychologist.
We believe that the use of temporary employees is a provisional solution to the more systemic staffing crisis
that FMC Devens faces.
At the time of our inspection in April 2024, the BOP’s contractor was still developing the staffing projection
tool’s recommended number of positions for FMC Devens’s Psychology Services Department and, therefore,
did not have a recommended staffing number. When the tool was finalized and released on October 1,
2024, after our fieldwork ended, it recommended increasing the total number of positions from 34 to 45 for
the Psychology Services Department. We note that the staffing tool references 34 rather than 33 positions
(as we described above) because it included in its count a staff psychologist position that is listed under the
Health Services Department on the FMC Devens staffing report. Since the Psychology Services Department
projection was not available during our inspection, we report these numbers for informational purposes; we
did not discuss the Psychology Services Department recommendation with FMC Devens employees or
Executive Leadership. After receiving a draft of this report, the Warden stated that FMC Devens would need
48 positions in the Psychology Services Department, which differs from the staffing projection tool’s
recommended 45 positions.
Given the long-standing challenges the BOP has experienced in determining appropriate staffing levels for
institutions, and the efforts it has thus far taken to align staffing levels with mission needs, we are
concerned that FMC Devens Executive Leadership’s assessment of the institution’s staffing needs differs
significantly with preliminary staffing projection tool estimates. Therefore, we recommend that the BOP:
1. Ensure that FMC Devens Executive Leadership and the Central Office’s Human Resource
Management Division discuss the staffing projection tool methodology and how it compares with
14
C.Agnello SE 0032
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 36 of 569 PageID #:
230
FMC Devens Executive Leadership’s understanding of its current and potential future mission needs
to ensure greater alignment between stakeholder staffing projections.
Inmate Healthcare
In addition to the Health Services and Psychology Services Department staffing challenges discussed in the
Staffing Challenges section above, we identified eight other areas of concern related to the provision of
healthcare to FMC Devens inmates:
1. potentially dangerous practices related to the distribution of buprenorphine and naloxone when we
observed the distribution of medication to inmates at the Camp;
2. a backlog of outside medical visits that had yet to be scheduled and a discrepancy in the number of
pending medical records between a company contracted by FMC Devens to facilitate outside
medical records and FMC Devens;
3. inconsistencies in inmates’ access to medical care for routine conditions;
4. inconsistencies in routine screening of inmates over age 50 for preventive healthcare or cognitive
impairment;
5. not all inmates with a diabetes diagnosis being tested within the required timeframes;
6. not all healthcare provider credential files being verified according to BOP policy;
7. improper placement of some inmates in the MDU; and
8. some medical inmate companions not meeting the BOP’s eligibility criteria and some performing
duties outside the scope of a medical inmate companion and prohibited by the BOP.
Potentially Dangerous Medication Distribution Practices
We identified a number of potentially dangerous practices, in violation of BOP policy and guidance, when we
observed the distribution of buprenorphine and naloxone medication to inmates at the Camp; the process
of distributing medications to inmates is known as “pill line.” Buprenorphine and naloxone are controlled
substances for which the BOP requires direct supervision for the duration of medication administration and
consumption. According to the BOP’s Opioid Use Disorder Guidance, institutions should consider how to
reduce diversion of controlled substances during pill line operations, which may include establishing
separate pill lines for observations of controlled substances. 10 To minimize the risk of diversion, BOP clinical
guidance states that the pill line for buprenorphine and naloxone should include direct supervision for the
duration of medication administration and consumption and a mouth check prior to administration and at
10BOP Opioid Use Disorder Guidance, January 2024. The BOP does not make this clinical guidance publicly available.
See Appendix 3 for the BOP policies and clinical guidance cited in this report.
15
C.Agnello SE 0033
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 37 of 569 PageID #:
231
the conclusion of the medication observation period. Diversion, which is defined as the illicit transfer or
sharing of controlled medications with others to whom the medication was not prescribed or dispensed,
can be particularly dangerous in a correctional setting: these medications have contraband value, as they
can sometimes result in a high. Diversion of these medications can also lead to altercations and violence
when the redistributed medications do not have the sought-after effects.
We found the following concerning pill line
practices for controlled substances among Health
Medications Used to Treat Opioid Use Disorder
Services Department employees at the Camp:
Buprenorphine and naloxone are medications that can
be combined and ingested orally through pills or
• They administered buprenorphine and dissolvable strips. When used appropriately, they can
naloxone to inmates during the routine help treat opioid use disorder by helping patients
morning medication administration, along manage withdrawal symptoms and reduce cravings.
with other inmates receiving daily Though the “high” is less intense than the high from
medications, without directly supervising opioids, the medication can still produce a euphoric
inmates who received buprenorphine and effect, as it still acts on the same opioid receptors in the
brain and creates a flood of dopamine in the brain.
naloxone for the duration of the medication
administration and consumption. Sources: BOP Opioid Use Disorder Guidance and
National Institutes of Health
• They did not conduct mouth checks before
or after administering buprenorphine and
naloxone to ensure that diversion did not occur or that the strip had fully dissolved.
We determined that buprenorphine and naloxone administration issues were neither limited to the period
of our inspection nor unknown to Health Services Department management. We reviewed quarterly
reports generated by department employees and circulated to department leadership and found that,
between January 2023 and April 2024, the department self-identified multiple medication administration
errors, including an inmate receiving a buprenorphine and naloxone sublingual film and a buprenorphine
injection on the same day.
In addition to noncompliance with policy and guidance, we observed a serious security concern during
medication administration at the Camp. Specifically, we observed that the door to enter the medication
room was not secured during medication administration. When the door is left unsecured, inmates may
gain access to prescription medications, which could endanger the safety and security of employees and
inmates at the institution. Further, we observed an employee administering medications permitting
inmates to enter the medication room to weigh themselves with little to no direct supervision from a BOP
employee, increasing the safety and security concerns.
To minimize the risk of medication errors, we recommend that the BOP:
2. Ensure that FMC Devens follows BOP guidance for buprenorphine and naloxone administration and
observation and that all FMC Devens employees who administer medication receive training on BOP
guidance and policies for medication administration.
16
C.Agnello SE 0034
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 38 of 569 PageID #:
232
Backlog of Outside Medical Visits and Medical Records
When inmates require nonemergency medical treatment in areas such as ophthalmology, neurology, and
radiology, which cannot be performed at FMC Devens, or they are admitted to an outside hospital, they
must be scheduled to see an outside medical provider. To help schedule and manage medical treatment
for inmates outside FMC Devens, the institution has a contract with a comprehensive medical services
company. Once a medical visit is scheduled by the contracted comprehensive medical services company,
FMC Devens employees escort the inmate to and from the appointment and supervise the inmate during
the appointment. After an outside medical visit or hospital stay is complete, the company is responsible for
securing the inmate’s medical records and, pursuant to the contract, submitting the records to FMC Devens
within 10 business days of the medical appointment or hospital discharge. When FMC Devens receives the
medical records, Health Services Department employees upload the records to the Bureau Electronic
Medical Records System (BEMR). Medical records typically include details regarding the circumstances of
the visit, the treatment plan, and follow-up care.
At the time of our inspection, BOP medical records indicated that 57 outside medical appointments that had
been ordered for inmates were yet to be scheduled; these outside medical appointments were overdue by
an average of 53 days. We also found a significant backlog in the number of outside medical records
pending receipt from the contracted company, as well as a discrepancy between the BOP and the
contracted company on the number of outside medical records that remained outstanding. The lack of
timely receipt of medical records can negatively affect physicians’ ability to provide necessary follow-up care
and could lead to serious health implications if FMC Devens medical employees do not know the
recommended treatment for inmates.
We identified two contributing factors for the scheduling backlog for outside medical trips: first, outside
medical providers canceled appointments; second, FMC Devens lacked enough employees to escort inmates
to scheduled appointments while maintaining coverage of necessary posts at the institution. While inmate
medical escort responsibilities are not reserved exclusively for Correctional Officers, they are the employees
at FMC Devens who are most commonly assigned to serve as medical escorts. FMC Devens employees
repeatedly expressed the strain that medical trips place on the Correctional Services Department and the
broader institution as the institution must use mandated overtime and augmentation to fill vacant custody
posts for Correctional Officers serving as medical escorts. In an effort to ease the staffing challenges of
outside hospital trips, FMC Devens established an agreement with a separate contracted company that can
accompany minimum- and low-security inmates to outside hospital admissions. We found that, in March
2024, 43 of these contracted employees provided 3,095 total hours of services at a cost of over $125,000 to
the institution. This need to use contract employees as a temporary and more costly solution further
demonstrates the importance of addressing the systemic staffing crisis that FMC Devens faces.
We also found a significant backlog in the number of pending medical records that the contracted company
indicated it needed to send to FMC Devens. According to the contract terms, outside medical records
should be provided to FMC Devens within 10 days of the outside medical appointment. As of September
2024, the contracted company’s backlog totaled 397 medical records that had not been sent to the BOP
within 10 days for inclusion in inmates’ medical files. In contrast, FMC Devens’s backlog totaled 237 medical
records. Of the contracted company’s 397 backlogged medical records; 6 were from 2019; 85 were from
2020; 18 were from 2021; 22 were from 2022; 71 were from 2023; and 195 were from January 2024 to
September 2024. The types of medical records that had yet to be entered into BEMR included outside
medical visits such as emergency room visits, transplant care, oncology consultations, and radiology
17
C.Agnello SE 0035
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 39 of 569 PageID #:
233
consultations. We found that the discrepancy in the medical record backlog was attributable to different
tracking methods and systems. Additionally, we believe that FMC Devens contract management employees
had not had consistent communication with the contracted company. As of September 30, 2024, FMC
Devens contract management employees had not reconciled the backlog with the contracted company. A
physician at FMC Devens expressed frustration with the backlog of medical records, explaining that delayed
medical records hinder their ability to provide adequate, continuous, and follow-up care to inmates with
medical needs.
Lastly, we reviewed 53 inmate medical files that were listed by FMC Devens as backlogged and found that
72 percent (38 of 53) contained the outside medical record in the inmate files. FMC Devens employees had
not properly indicated that the medical record had been received during its upload into BEMR, which caused
the record to remain on FMC Devens’s backlog list even though the record was in the inmate’s file and
accessible by physicians and nurses. Additionally, FMC Devens Health Services Department management
had not completed quality control checks of the inmate medical record receipt and upload process as of
September 30, 2024. We believe that the lack of oversight of outside medical records could lead to
fragmented inmate care and could exacerbate conditions that inmates were sent to outside providers to
address.
Relevant Prior OIG Work and Related Recommendations: Canceling and Rescheduling Outside Medical Visits
In a March 2022 audit report on the BOP’s use of comprehensive medical services contracts to facilitate outside
medical care for inmates, we found that, due to the limited availability of employees to escort inmates, the BOP was
not always able to transport inmates to scheduled outside medical appointments. BOP officials also told us that
appointments are rescheduled for other, unanticipated reasons, such as inmate refusal to attend the appointment,
illness of the inmate, or rescheduling required by the medical provider. During our audit, we found that the BOP
does not adequately track canceled or rescheduled inmate appointments, and we were unable to determine the
effect these cancelations and rescheduling had on the delivery of timely medical care to inmates. As a result, we
recommended that the BOP implement a reliable, consistent process throughout all BOP facilities to monitor and
analyze wait times for outside inmate appointments and the causes for canceled or rescheduled appointments in
order to ensure that inmates receive timely medical care. As of the publication of this report, this recommendation
remains open.
See Appendix 2, Item XIII, for more information about this report.
To ensure that medical records are received in a timely manner and to assist medical providers with
diagnosing and treating their patients, we recommend that the BOP:
3. Implement a plan to address the medical record backlog at FMC Devens.
4. Ensure that FMC Devens develops a consistent and accurate medical record tracking procedure with
the contracted company that includes regular and recurring reconciliation of outside inmate medical
records between FMC Devens and the contracted company.
18
C.Agnello SE 0036
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 40 of 569 PageID #:
234
Inconsistent Processes for Requesting and Accessing Care
We found that, due to a variety of reasons, FMC Devens inmates may have difficulty accessing medical
care for routine conditions. The most common way FMC inmates access medical care is by visiting the walk-
in clinic; Camp inmates submit a request-to-be-seen form. Both processes are known as “sick call.” BOP
policy dictates that all medical processes, including sick call and patient care, treatment, and services, be
logged and tracked within BEMR. At the time of our inspection, we found that FMC Devens was not always
following BOP policy regarding the use of BEMR. For example, we found that many nursing employees were
using a paper logbook or paper forms to document and track sick call, whereby they entered an inmate’s
name, register number, complaint, and appointment date and time. We also learned that paper forms were
not entered into BEMR and were later shredded, making it difficult to track sick call records. When we
discussed this inconsistency with FMC Devens Health Services Department management, we were told that
all nursing employees should use BEMR and that nurses used the tracking logbook only as a back-up. We
believe that there is a lack of communication between Health Services Department management and
nursing employees and that a lack of direct supervision of nursing duties by nursing supervisors caused this
discrepancy, which we believe is concerning and creates a risk that inmate care will be delayed.
Additionally, there appeared to be inconsistency in how FMC Devens nursing employees determined what
constituted a need for sick call. According to BOP policy, “Sick call is defined as an inmate-initiated request
for care.” One inmate told us that when they went to sick call they were turned away by nursing employees
because their request for care did not comport with how the nurse defined a sick call visit. We found that
this issue also related to the lack of communication and oversight by FMC Devens’s Health Services
Department management. More alarming, we found that not all nurse managers at FMC Devens knew what
constituted a need for sick call. One nurse manager told us that inmates who show up for medication refills
should not report to sick call; rather, they should talk to Health Services Department supervisors during
meal services, email the Health Services Department, or stop by the pharmacy to have their issues
addressed. However, the FMC Devens Admission and Orientation Handbook given to inmates upon
admission states that, “if there are no refills remaining, it is the inmate’s responsibility to sign up for sick call
to have the prescription renewed in adequate time.” The inconsistency between actual practice and inmate
guidance may limit an inmate’s ability to be seen and receive medication in a timely manner, which could
negatively affect their overall health.
Further, we found, through our review of inmate medical records, that 13 percent (2 of the 16 inmates who
were evaluated for sick call complaints) did not have a sick call or triage note documented in BEMR. FMC
Devens procedures require the nurse, licensed practical nurse, or medic to complete a triage or sick call
note in BEMR to include inmate complaint, history, vital signs, physical findings, and disposition. Triage
allows truly urgent conditions to be addressed adequately on the same day, while also allowing more
routine conditions or concerns to be addressed at a scheduled appointment. Failure to triage inmates may
limit FMC Devens’s ability to prioritize inmate healthcare and further diagnose and treat urgent conditions.
To ensure that all inmates can request and have access to care, we recommend that the BOP:
5. Ensure that FMC Devens follows the BOP Patient Care Policy for sick call and provides training to all
FMC Devens Health Services Department employees on the policy, as well as on FMC Devens sick call
procedures.
19
C.Agnello SE 0037
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 41 of 569 PageID #:
235
Lack of Preventive Healthcare Screenings
The BOP Clinical Practice Guidelines (CPG) for
Preventive Healthcare Screening states that
Preventive Healthcare Screening Requirements for
periodic prevention visits are an effective way to Inmates Over Age 50
provide preventive healthcare services for all
The BOP CPG for Preventive Healthcare Screening states
inmate patients but especially those that are not
that preventive healthcare services for inmate patients
routinely seen for other medical needs such as
incorporates targeted patient counseling and
chronic medical conditions. 11 The BOP encourages
immunizations, as well as screening for infectious diseases,
prevention visits annually for inmates 50 years and cancer, cognitive impairment, and chronic diseases. It also
older. According to the BOP CPG for Preventive includes recommendations for disease screening based on
Health Care Screening: age, sex, clinical indication, and risk factors. Current
preventive health requirements for male inmates over age
50, based on risk factors, include colon cancer, lung cancer,
• Clinical Directors are responsible for serving
diabetes, hypertension, cholesterol, cardiovascular disease,
as role models and leaders in delivering abdominal aortic aneurysm, and cognitive screening.
preventive health services; providing Additionally, the BOP encourages annual prevention visits
standing orders for nurses; providing staff for inmate patients 50 years and older.
education; developing Improving
Source: Appendix 3 (Preventive Health Care, Colorectal
Organizational Performance measures; and
Cancer, and Cognitive Impairment Screening)
working with the Health Services
Administrator to ensure that adequate
staffing, supplies, and materials are
available for successful implementation of the local preventive healthcare program.
• All members of the healthcare team should take part in preventive healthcare in some capacity,
under the collaborative leadership of the Health Services Administrator and the Clinical Director.
• Health Service Administrators, Clinical Directors, and the Director of Nursing should develop a
process and outline the implementation of a local preventive healthcare program.
At the time of our inspection, we found that a senior medical official was not using the CPG for Preventive
Healthcare Screening and was not instructing the physicians at FMC Devens to use the CPG for Preventive
Healthcare Screening. A physician told us that he had not received training or guidance related to
preventive health. We also found no evidence that FMC Devens had established a local preventive
healthcare program. We find it concerning that a Federal Medical Center does not have a local preventive
healthcare program and that a senior medical official was not using the CPG for Preventive Healthcare
Screening.
To determine whether inmates over age 50 were receiving preventive healthcare screenings, we reviewed a
random sample of 5 percent (21 of 413) of the medical records for inmates over age 50. We found that only
48 percent (10 of 21) of the inmates had received a preventive health screening during the previous year.
We further determined that all 48 percent of inmates who had received a preventive health screening
received their screening in conjunction with a chronic care clinic, for which they were already enrolled, and
11 Appendix 3 (Preventive Health Care, Colorectal Cancer, and Cognitive Impairment Screening).
20
C.Agnello SE 0038
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 42 of 569 PageID #:
236
the screening was performed by a physician. Chronic care clinics are defined as a means for inmates with
ongoing medical needs to be tracked and seen by a healthcare provider at clinically appropriate intervals.
For the 52 percent of inmates whose records we reviewed who had not received a preventive health
screening during the previous year, 73 percent (8 of 11) were enrolled in a chronic care clinic but had not
received a preventive health screening and 27 percent (3 of 11) were not enrolled in any chronic care clinics.
Regarding preventive health screenings, a physician told us, “If a person is not in a chronic care clinic, they
could be here for years and never be seen.” 12 We find this concerning because the lack of preventive
healthcare screening could potentially delay the care of inmates over age 50, which could negatively affect
their overall health and result in the need for more costly treatment.
Further, we found that none of the 21 inmates over age 50, including the 10 who had a preventive health
screening, had received a cognitive impairment screening as part of their preventive healthcare. According to
the BOP CPG for Preventive Healthcare Screening, inmates 50 years old or older, without recognized signs or
symptoms of cognitive impairment, should be screened for cognitive impairment using a “Mini-Cog”
screening tool. The BOP uses the Mini-Cog tool as a fast and simple screening test to help detect dementia in
its early stages. We find the lack of cognitive impairment screening at FMC Devens concerning because, at
the time of our inspection, 44 percent of its inmate population was over age 50 and should receive this
screening for appropriate healthcare monitoring. FMC Devens is one of only seven Federal Medical Centers
and, as such, should prioritize inmate healthcare. In addition, because FMC Devens houses the BOP’s only
MDU, it should be properly screening inmates for cognitive impairment (discussed in the Memory Disorder
Unit section below).
Additionally, the BOP CPG for Preventive Healthcare Screening states that inmates between ages 45 and 75
at average risk for colorectal cancer should receive an annual screening to detect potential signs of colon
cancer. 13 If the results of that screening indicate potential signs of colon cancer, the BOP CPG for Preventive
Healthcare Screening states that the inmate should receive a colonoscopy. 14 As of April 2024, FMC Devens
had 371 inmates at average risk for colorectal cancer, 93 percent of whom were offered screening (the
scope of this inspection did not include analyzing the institution’s compliance in providing colonoscopies to
eligible inmates). Preventive colorectal cancer screenings are important because early disease detection can
improve health outcomes and mitigate the need for more costly treatments. Given the importance of
ensuring that inmates at risk of colon cancer have access to preventive screenings, in April 2024 we initiated
12 After receiving a draft of this report, the BOP noted that it educates inmates about how to access medical care for
chronic care diagnoses and preventive health visits for routine, age-appropriate assessments and screenings and
informs inmates that they are entitled to no-cost preventive health visits at appropriate intervals (recommended to
occur every 3–5 years but as often as annually based on age and health risk factors) but the onus is on the inmates to
seek and request this care. The BOP added that some inmates may elect to not request medical services or to refuse
medical services.
13 Appendix 3 (Preventive Health Care, Colorectal Cancer, and Cognitive Impairment Screening).
14 If an inmate is determined to be at increased risk for colorectal cancer, the BOP’s CPG for Preventive Healthcare
Screening (see Appendix 3 (Preventive Health Care, Colorectal Cancer, and Cognitive Impairment Screening)) refers
providers to cancer prevention organizations’ recommendations for colorectal cancer early detection. Factors that
increase an individual’s risk for colon cancer include a history of polyps, past diagnosis of colorectal cancer, family
history of and genetic predisposition to colon cancer, and inflammatory bowel disease.
21
C.Agnello SE 0039
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 43 of 569 PageID #:
237
a broader evaluation of inmate colorectal cancer screening practices and clinical follow-up on colorectal
cancer screening results across the BOP.
To ensure that inmates receive appropriate preventive healthcare screenings, we recommend that the BOP:
6. Ensure that FMC Devens follows the BOP’s Clinical Practice Guidelines for Preventive Healthcare
Screening to establish a local preventive healthcare program and utilize all members of the
healthcare team in preventive healthcare.
7. Ensure that all FMC Devens inmates over age 50 are receiving preventive healthcare screenings,
including cognitive impairment screening.
Management of Diabetes
According to the BOP CPG for Preventive
Healthcare Screening, an A1C level should be A1C Testing
obtained every 3 months for a diabetic inmate with
An A1C level is obtained by testing an individual’s blood
an A1C level above their individualized target, which
to determine the average amount of sugar in their blood
is generally 7–7.5 percent. 15 The guidelines further over the preceding 3 months.
provide that an A1C level should be obtained every
A1C testing helps clinicians and patients manage diabetes
6 months for a diabetic inmate with an A1C level
effectively by providing clinicians information to make
below 7 percent. We reviewed the medical records
timely adjustments to patient treatment plans and to
of 20 FMC Devens inmates with a diabetes recommend lifestyle modifications and prevention
diagnosis and found that all 20 were enrolled in a strategies.
diabetes chronic care clinic and had been evaluated
Source: Appendix 3 (Management of Diabetes)
by a physician annually. However, we found that 5
of the 20 diabetic inmates (25 percent) we reviewed
with A1C levels above 7.5 percent had not had an
A1C test every 3 months, as outlined by the BOP CPG for Preventive Healthcare Screening, preceding our
inspection; the remaining 15 inmates did have A1C testing as provided for in the guidelines.
Insufficient Oversight of Healthcare Provider Credential Files
According to BOP policy, each Health Services Unit should verify the professional credentials of all institution
healthcare providers. 16 Providers include BOP employees, Public Health Service employees, part-time
employees, contract and consultant employees, and those who provide a diagnosis or treatment using
telehealth. BOP policy also requires those who are working under a practice agreement (or a collaborative
practice agreement for pharmacists) to have at least one routine peer review every 2 years, which may be
conducted by a peer reviewer at a BOP institution. 17 (See the text box below for definitions of these terms.)
15 Appendix 3 (Management of Diabetes).
16 Appendix 3 (Credential Verification and Peer Review).
17 Appendix 3 (Credential Verification and Peer Review).
22
C.Agnello SE 0040
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 44 of 569 PageID #:
238
We reviewed 23 credential files (17 percent) of the
138 employees at FMC Devens required to have
Peer Review, Practice Agreements, and Collaborative
credentials, which included physicians, nurses,
Practice Agreements
advance practice providers, a pharmacist, a physical
therapist, and a psychiatrist. 18 We found that FMC Peer review is the routine function used to review the
Devens failed to verify a credential file for the current knowledge and skills of BOP healthcare
providers. A peer review includes evaluating the
psychiatrist and to conduct a peer review of the
professional care the provider gives and providing
pharmacist providing inmate care through a
comment on areas such as clinical performance,
collaborative practice agreement. The credential appropriate utilization of resources, clinical judgment,
file reviewer at FMC Devens told us that they were and technical skills.
unaware that the psychiatrist was providing
Practice agreements detail specific clinical or dental
telepsychiatry services to FMC Devens inmates.
duties for employees who work under a licensed
independent practitioner within BOP institutions.
Therefore, the credential file reviewer had not A collaborative practice agreement describes a specific
verified the psychiatrist’s credential file prior to the plan or arrangement or a specific sequence of orders,
psychiatrist providing telepsychiatry services. We steps, or procedures to be followed in providing patient
care services.
have concerns with FMC Devens’s credential file
accountability and verification given that the Source: Appendix 3 (Credential Verification and Peer Review)
credential file reviewer was unaware of who was
practicing telehealth and whether their credentials
were valid. We believe that, without verifying a
provider’s license, knowledge, or skills, FMC Devens is unable to ensure the quality and efficiency of care
delivered to inmates.
Similarly, the BOP requires routine peer reviews to ensure that healthcare providers have the appropriate
knowledge and skills to offer healthcare to inmates. We believe that the failure to conduct peer reviews in
accordance with BOP policy could compromise the quality of healthcare delivered to inmates at FMC Devens
and could also increase safety and liability risks for the BOP.
To ensure that the professional credentials of all FMC Devens healthcare providers meet BOP requirements,
we recommend that the BOP:
8. Ensure that FMC Devens verifies the credential files of all providers prior to allowing them to administer
care to inmates, and ensure that FMC Devens completes peer reviews in accordance with BOP policy.
Inappropriate Inmate Placement in the Memory Disorder Unit
We reviewed the medical records of all 16 inmate patients in the MDU at the time of our inspection and
determined that 25 percent (4 of 16) of those inmates were not appropriately housed in the MDU based on the
criteria established by FMC Devens. The criteria state that inmates admitted to the MDU must have been
diagnosed with dementia and not be prone to violence. We identified one inmate without a dementia
diagnosis, one inmate who both lacked a dementia diagnosis and was prone to violence, and two inmates who
18As of August 2024, FMC Devens maintained eight credential files for employees who were working there as a
temporary duty location. We did not include those eight files in our review.
23
C.Agnello SE 0041
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 45 of 569 PageID #:
239
had a dementia diagnosis but were prone to violence. Specifically, one inmate had a diagnosis of Huntington’s
disease, which may result in dementia; but at the time of the inspection he did not have a dementia diagnosis.19
The second inmate had a non-dementia neurocognitive diagnosis and was also prone to violence. He had been
approved for transfer to another institution in February 2024 due to violent behavior but remained at FMC
Devens at the time of our inspection. Additionally, two inmates in the MDU had a dementia diagnosis but were
prone to violence. FMC Devens employees expressed concern with the appropriateness of inmates receiving
care in the unit. Those employees told us that, at times, FMC Devens uses the MDU as a housing unit for
inmates who have behavioral issues and cannot be housed elsewhere in the institution, further stating that
some of those inmates are incredibly violent and aggressive toward other inmates and MDU employees.
Housing inmates without a dementia diagnosis in the MDU results in the misuse of the bed space in this unit
and limits the BOP’s ability to house inmates with dementia at FMC Devens (the only MDU within the BOP).
As described in the Health Services Staffing Shortages section of this report, due to the shortage of
healthcare staff, FMC Devens requested a pause in inmate admissions to the MDU, which BOP Central Office
approved in April 2024. Additionally, housing violent inmates in the MDU poses a safety risk to other MDU
inmates and employees, potentially exacerbates staffing issues, and can create liability issues for the BOP.
To ensure that the BOP’s only MDU houses only those inmates who meet FMC Devens’s criteria, we
recommend that the BOP:
9. Ensure that inmates admitted to and housed in the Memory Disorder Unit are appropriately placed
in accordance with FMC Devens’s established criteria.
Potentially Dangerous Medical Inmate Companion Program Practices
FMC Devens operates a medical inmate companion program to assist and support inmates who are unable
to independently perform one or more activities of daily living, such as brushing teeth, combing hair, or
putting on shoes. Inmate companions also assist with escorting inmates to medical appointments and pill
lines and encourage compliance with medical treatment. The BOP prohibits medical inmate companions
from assisting with toileting, bathing, and changing undergarments and incontinence products; viewing or
touching genitalia; and performing certain medical activities such as taking vital signs and administering
medications. To become a medical inmate companion, inmates must apply, and, if hired, are trained by
institution employees. According to BOP eligibility criteria, medical inmate companions must not have had a
significant incident report in the prior 12 months; a history of perpetrating sexual abuse, predatory
behaviors, and violent crimes; medical restrictions; or physical limitations that could impede their ability to
complete inmate companion tasks. At the time of our inspection, FMC Devens had 22 medical inmate
companions working in the medical housing units.
We found that some medical inmate companions at FMC Devens did not meet the BOP’s eligibility criteria and
some were performing prohibited duties. Of the 22 medical inmate companions at FMC Devens, we found
that 14 percent (3 of 22) had committed a sexual offense, 36 percent (8 of 22) had committed a violent offense,
19 Huntington’s disease is an inherited disorder that causes nerve cells in parts of the brain to gradually break down and
die. National Institute of Neurological Disorders and Stroke, “Huntington’s Disease,” www.ninds.nih.gov/health-
information/disorders/huntingtons-disease#:~:text=What%20is%20Huntington’s%20disease%3F,as%20well%20
as%20other%20areas (accessed July 19, 2024).
24
C.Agnello SE 0042
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 46 of 569 PageID #:
240
and 27 percent (6 of 22) were Medical Care Level 4 inmates with medical restrictions. These companions
should have been prohibited from becoming a medical inmate companion based on the BOP’s eligibility
criteria. When we asked Health Services Department employees what duties medical inmate companions
were performing at FMC Devens, they said that some medical inmate companions were performing duties
outside the roles and responsibilities of an inmate companion due to the Health Services Department staffing
crisis and nurse shortages. These duties included assisting with showers and cleaning genitalia because they
were told by Health Services Department employees that they needed to perform those duties due to nursing
vacancies. We are concerned that FMC Devens is not following the BOP’s medical inmate companion program
criteria, which we believe may place inmates requiring companion assistance at an increased risk for violence,
abuse, victimization, or improper medical care; may put employees at increased safety and liability risks; and
may have medical inmate companions performing duties that they are not qualified to perform or being
placed in situations that could expose them to allegations of abuse and misconduct.
To ensure that medical inmate companions are appropriately selected for their roles and not engaging in
prohibited duties, we recommend that the BOP:
10. Ensure that FMC Devens adheres to BOP policy on medical inmate companion screening and hiring
and that FMC Devens employees screening and hiring these companions are trained on the policies
and procedures.
11. Ensure that FMC Devens evaluates the roles and responsibilities of medical inmate companions to
ensure that they are not performing duties outside the scope of the inmate companion program.
Safety and Security
In addition to our concerns about staff availability and the effect that low staffing can have on the safety of
institution operations, as described in the Staffing Challenges section of this report, we identified two other
safety and security issues at FMC Devens during our inspection. First, we found that Correctional Officers
failed to complete about half of the required inmate-monitoring rounds in the housing units that hold
inmates at the highest medical and mental health care levels. Second, we found multiple deficiencies in the
institution’s radio system, including “dead zone” areas that lack adequate radio reception, as well as
outdated radios. We describe both of these safety and security issues in greater detail below.
Failure to Complete Rounds
FMC Devens Correctional Officers are required to adhere to housing unit-monitoring instructions, also
known as post orders, which state that Correctional Officers must complete irregularly timed rounds within
each 30-minute block of time while working a post in a housing unit. However, after reviewing 280 hours of
overnight security camera footage, we found that collectively only half of the required rounds (53 percent)
were completed in the MDU, hospital unit, and transitional mental health step-down unit, leaving vulnerable
inmates unobserved for multiple hours each night. This is a significant concern because inmates housed in
these units pose an increased risk not only for self-harm and suicide, but also for medical-related
emergencies such as seizures and falls. Given that rounds are essential checks to verify inmate well-being, a
manager in FMC Devens’s Correctional Services Department expressed frustration at the lack of rounds
completed by Correctional Officers we observed during the portion of the video footage we reviewed while
25
C.Agnello SE 0043
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 47 of 569 PageID #:
241
on site. Our observations of incomplete inmate-monitoring rounds are consistent with findings in prior
work, including two of our previous inspections (see the text box below).
Relevant Prior OIG Work and Related Recommendations: Inmate-Monitoring Rounds
The OIG’s June 2023 report on its investigation and review of the BOP’s custody, care, and supervision of Jeffrey Epstein at
Metropolitan Correctional Center New York found many inmate-accountability deficiencies. For example, the OIG’s
investigation determined that staff failed to conduct mandatory rounds and inmate counts, resulting in Epstein being
unobserved for hours before his death. As such, the OIG recommended that the BOP evaluate its methods of accounting
for inmate whereabouts and well-being and make changes, as appropriate, to improve those methods through policy,
training, or other measures. As of the publication of this report on FMC Devens, this recommendation remains open.
Our February 2024 report that evaluated issues surrounding BOP inmate homicide, suicide, accidental, and unknown
deaths found that BOP staff did not sufficiently conduct required rounds or counts of inmates, which are important
opportunities to monitor inmate well-being, in over a third of the inmate suicides during the scope of the evaluation.
Such deficiencies helped foster conditions in which inmates were able to advance their suicidal ideations and created
increased opportunities for them to die by suicide. The number of inmate suicides increased each year from fiscal
year (FY) 2019 to FY 2021, the most recent years in the evaluation scope, and FY 2021 had the highest number (31) of
suicides in a single year during the scope. While this report did not make any recommendations regarding inmate-
monitoring rounds, it did encourage the BOP to take swift action to address our 2023 Epstein report
recommendations to evaluate inmate-accountability methods.
Our inspections of FCI Tallahassee and FCI Sheridan found that Correctional Officers did not always conduct inmate-
monitoring rounds in housing units. At FCI Tallahassee, during our on-site review of video footage, we found that a
staff member failed to make required rounds during two consecutive overnight shifts in the male detention center,
leaving inmates unobserved for multiple hours each night. Our finding was consistent with findings of the BOP
Program Review Division’s August 2022 Correctional Services program review, conducted by staff external to FCI
Tallahassee, which found that staff were not always conducting rounds in the Special Housing Units consistent with
BOP policy. At FCI Sheridan, we found that, during an evening just prior to our inspection, Correctional Officers
conducted less than half of the required twice-hourly rounds in three housing units between 9:30 p.m. and 6 a.m.
Further, we learned that on certain evenings the sole employee assigned to supervise the Camp at FCI Sheridan may
need to respond to the medium-security prison or detention center in the event of an emergency. When this
happens, Camp inmates are left unsupervised. Although we did not collect evidence to determine the exact number
of times this has occurred, FCI Sheridan employees told us that it happens regularly.
See Appendix 2, Items II, III, VI, and VIII, for more information about these reports.
Ongoing Camera Upgrades and Persistent Radio Deficiencies
The OIG has repeatedly identified deficiencies in the BOP’s security camera system that affect institutional
safety and security across the BOP. Our previous findings related to security camera deficiencies (see
Appendix 2, Items IX and X) contributed to the Prison Camera Reform Act of 2021, which required the BOP
to address these deficiencies and make necessary upgrades to security camera systems BOP-wide.
Additionally, as described in the text box below, the Prison Camera Reform Act required the BOP to address
radio system deficiencies at all BOP institutions. At the time of our inspection, fiberoptic cable was being
installed at FMC Devens to upgrade analog security cameras to digital and 100 additional security cameras
were being installed to cover blind spots.
However, we are concerned that radio system deficiencies were not being addressed at FMC Devens. At the time of
our inspection, we found the following deficiencies with FMC Devens’s radio system:
26
C.Agnello SE 0044
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 48 of 569 PageID #:
242
• Employee radios did not receive radio signals
in some parts of the institution, namely the Prison Camera Reform Act of 2021: Radio System
hospital and areas below ground. The lack of Upgrades
radio reception in the hospital areas could The Prison Camera Reform Act of 2021 required the BOP
impede the medical team’s ability to respond Director to address deficiencies and make necessary
to a medical emergency and call for additional upgrades to radio systems to ensure the health and safety
assistance, if needed, and could inhibit the of employees and inmates. Specifically, the Act required
response of Correctional Officers during the BOP to identify and plan how to address radios that
nonmedical emergencies, jeopardizing the lack an emergency notification feature, known as a “man
safety of employees and inmates. down” function, which automatically sends an alert and
transmits the location of that radio in the event the wearer
is in a prone position. Additionally, the Prison Camera
• Employee radios were beyond their Reform Act required the BOP Director to ensure that BOP
serviceable dates, rendering many radios facilities have security camera coverage and capabilities
unrepairable. Institution management told necessary to ensure the documentation and accessibility
us that the battery life of the radios has of video evidence pertaining to misconduct, maltreatment,
degraded to the point that radios lack or criminal activity within correctional facilities.
sufficient battery life to last the length of an Source: Prison Camera Reform Act of 2021
employee’s shift. The outdated radios also
lack a “man down” function, as described in
the text box.
FMC Devens employees repeatedly expressed concern and frustration with the radios, informing us that
these deficiencies are a life safety risk. After receiving a draft of this report, the BOP told us that repairs
were made to FMC Devens’s radio signal system to improve radio reception in the hospital building. We did
not return to FMC Devens to assess the updates to the system.
Inmate Programming
As required by the FIRST STEP Act of 2018 (FSA), BOP institutions conduct a needs assessment on all
sentenced inmates entering their custody to identify specific Evidence-Based Recidivism Reduction
programs and Productive Activities that will best prepare the inmates for their reentry into society. 20 We
found that FMC Devens offered various psychology-based and educational programs to its inmates.
However, employee shortages in the Psychology Services and Education Departments, as well as the
augmentation of non-custody employees into Correctional Officer posts, created significant backlogs for
these programs. As a cumulative result of these issues, waitlists for many inmate programs exceeded
100 names, only 1 skills-based vocational program was offered, and the FSA-funded LifeSkills Laboratory
program was completely unused.
On average, FSA programs offered by the Psychology Services Department had the longest waitlists across
the institution, with the waitlist for the Anger Management course holding 237 inmates (25 percent of FMC
Devens’s inmate population) at the time of our inspection. Psychology Services Department employees
attributed the long waitlists to staffing challenges and the lack of available psychologists to facilitate
programs at FMC Devens (as described in the Psychology Services Staffing Shortages section of this report).
20 18 U.S.C. § 3632(a).
27
C.Agnello SE 0045
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 49 of 569 PageID #:
243
Due to staffing challenges, the Psychology Services Department also had to prioritize programming for
inmates with higher mental health care levels, leaving inmates with lower mental health care levels with a
lack of programming and resources.
Similarly, insufficient staffing levels in the Education Department limited FMC Devens from offering General
Education Diploma courses, the Commercial Driver’s License program at the Camp, and the Certified Nursing
Assistant program at the FMC. As a result, the equipment and materials for these courses sat unused.
We also found that FMC Devens has only one vocational program offered for the entire institution; this was
its Culinary Arts Program, which included a Barista Program. Moreover, this program had space for only
10 inmates to participate and had 70 inmates on a waitlist. The Culinary Arts Program is designed to train
inmates to be better equipped to obtain jobs in the food services industry upon release from prison, and
the food and beverages prepared by inmates are made available to FMC Devens employees for purchase.
See the photographs below for examples of the Culinary Arts Program.
Left, Culinary Arts Program Weekly Menu Board, Right, Culinary Arts Program Barista Program Bar
Source: OIG, April 2024 (Left Image Employee Faces Blurred and Right Image Product Names and Logos Blurred)
Left, Culinary Arts Program “Surf and Turf” Lunch, Right, Culinary Arts Program Dessert
Source: OIG, April 2024
28
C.Agnello SE 0046
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 50 of 569 PageID #:
244
LifeSkills Laboratory
The LifeSkills Laboratory is a BOP-wide initiative started in 2020 to help inmates with serious mental
illnesses be better prepared upon release from prison to practice routine daily life skills, including health
and hygiene, budgeting and shopping, manners and self-advocacy, cleaning and clothing care, and cooking.
A BOP institution’s LifeSkills Laboratory space includes a model store with a banking area, laundry room,
and kitchen; see the photographs below for the space at FMC Devens.
Left, LifeSkills Laboratory Kitchen, Right, LifeSkills Laboratory Laundry Room
Source: OIG, April 2024 (Left and Right Image Product Names Blurred)
Left and Right, LifeSkills Laboratory Store
Source: OIG, April 2024 (Left and Right Image Product Names Blurred)
In FY 2021 FMC Devens received $150,000 of FSA funds as one of three BOP institutions selected to pilot the
initial implementation of the FSA LifeSkills Laboratory program. With those funds, the institution renovated
available Psychology Services Department space to create a brand new LifeSkills Laboratory, which was
completed in FY 2023. However, as of FY 2025, FMC Devens had yet to enroll inmates in this program
because it had not been allotted a Specialty Treatment Program Specialist position to oversee the program
29
C.Agnello SE 0047
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 51 of 569 PageID #:
245
until FY 2024 and had not filled the vacant position as of the beginning of FY 2025. We are concerned that,
3 years after FMC Devens received funding to be a pilot site, the LifeSkills Laboratory there is not
operational and inmates are not benefiting from this program. As of June 25, 2024, 10 BOP institutions,
including FMC Devens, had been approved and had received FSA funding for a LifeSkills Laboratory.
However, only one institution, U.S. Penitentiary Allenwood, had been fully activated. Given the importance
of FSA programming, in November 2024 we initiated a broader evaluation of the BOP’s implementation and
operation of FSA programming.
Physical Conditions and Infrastructure
As we have observed at other BOP institutions, we found that FMC Devens has several unfunded major
infrastructure and equipment repair projects that present safety and security issues. As of February 2024,
FMC Devens management estimated that the total cost to complete those projects was $15 million. We are
concerned that, if these repairs are not made soon, equipment will fail, which would not only negatively
affect the conditions of confinement for inmates but would also cause repair and replacement costs to
exceed current estimates. This issue is not unique to FMC Devens. The BOP found that weakened roofs
across its institutions contributed to damaged security systems due to water intrusion. 21 The BOP estimated in
January 2024 that it had a $3 billion backlog of infrastructure maintenance and repairs across all of its
institutions.
FMC Devens Facilities Department employees told us that many of the institution’s systems are approaching
the end of their projected lifespan and need to be updated and that roofs need repair. The costliest
proposed repair project at FMC Devens, estimated at $8 million, is to replace the FMC’s heating and cooling
systems. Additionally, repairs to the FMC’s roofs are estimated at $4 million. FMC Devens requested funds
to address these issues through its Regional Office; however, due to the BOP’s limited budgetary resources
for infrastructure repair and replacement, the request was unfunded at the time of our inspection.
During our inspection, we saw evidence of significant water intrusion caused by compromised roofs throughout
the FMC, including multiple housing units, employee offices, the chapel, the optometry examination room, and the
dialysis unit. In one instance, an employee moved an inmate to a different cell due to water intrusion. Another
employee expressed concern that water intrusion in the FMC’s optometry examination room would damage
expensive equipment and was also a slip hazard. See the photographs below for evidence of water damage
throughout the institution.
21This data is included in a document submitted by DOJ to the U.S. Senate Committee on the Judiciary on November 7,
2024, titled “A Funding Proposal to Address Critical Safety Needs Across the Federal Prison System.”
30
C.Agnello SE 0048
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 52 of 569 PageID #:
246
Left, Water Damage to the Ceiling in the Medical Office Area; Middle, Equipment in the Optometry Examination Room
Covered to Prevent Damage from Water Intrusion; Right, Buckets Used to Catch Water and Covers over the
Optometry Equipment to Prevent Water Damage
Source: OIG, April 2024 (Middle Image Darkened to Highlight Its Subject and Right Image Product Names and Logos
Blurred)
Left, Ceiling Tiles Missing above a Bed; Middle, Water Damage to a Housing Unit’s Ceiling; Right, Buckets in Front of
Cells below a Water-damaged Ceiling
Source: OIG, April 2024 (Right Image Faces Blurred)
31
C.Agnello SE 0049
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 53 of 569 PageID #:
247
Left, Water Damage to the Ceiling in the Chapel; Middle, Ceiling in an Employee’s Office Showing Signs of Water
Intrusion above the Computer and Desk Chair; Right, Trash Can Used to Catch Water Leaking from the Ceiling near an
Employee’s Office
Source: OIG, April 2024 (Middle Image Darkened to Highlight Its Subject and Product Names and Logos Blurred)
Although not identified by the BOP as in need of significant repair or replacement, we found three
additional areas of concern: inoperable showers in medical housing units, shower floor mats in the medical
housing units that were misaligned and could cause falls, and missing mortar in the Special Housing Unit’s
(SHU) recreation walls. Specifically, we found that some of the inmate shower stalls inside the medical
housing units were not working, which required inmates in those areas to use shared shower stalls in the
hallways rather than in their own cells. The shared shower stalls were limited to four stalls in each housing
unit, and only one shower stall in each housing unit was designated as handicap accessible. As this is an
area that houses Medical Care Level 3 and 4 inmates, the lack of handicap-accessible showers and the
inability of inmates to use their own, individual stalls could make it more difficult to shower for those with
disabilities and for those who have medical equipment they need to use or clean in the shower.
We also found, as shown in the photograph below, that the nonslip shower mats in the communal shower
stalls in one medical housing unit did not fully cover the shower floors and were misaligned. Inmates in this
housing unit were concerned that the shower mats presented a slipping risk to inmates with disabilities.
When we discussed this concern with FMC Devens management, they said that they would address the
issue. After the on-site portion of our inspection, FMC Devens reported that it had repainted the majority of
the shower stall flooring in the medical housing units with abrasive flooring paint, as shown in the
photograph below, and repositioned mats under shower chairs in the shower stalls.
32
C.Agnello SE 0050
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 54 of 569 PageID #:
248
Left, Two of the Shared Shower Stalls in a Medical Housing Unit’s Hallway, Right, an Inoperable Shower Stall in an
Inmate’s Cell That the Inmate Was Using for Storage, Located in a Medical Housing Unit
Source: OIG, April 2024
Left, Medical Housing Unit’s Shower Stall with Misaligned Mats That Were a Tripping Hazard, Right, Housing Unit’s
Shower Stall Sprayed With an Abrasive Flooring Paint After the On-site Portion of Our Inspection
Sources: Left, OIG, April 2024, Right, FMC Devens Employee, July 2024
33
C.Agnello SE 0051
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 55 of 569 PageID #:
249
We also found multiple areas of missing mortar between bricks in the SHU recreation yard, which serves as
a barrier between the SHU’s separate outdoor recreation area and a sidewalk used by inmates in the
general population (see the photographs below). We believe that there are safety and security risks
associated with the missing mortar due to the dual accessibility. For example, inmates could pass messages
and contraband through the holes. We are also concerned that inmates could further damage the mortar
by chipping away at the damaged locations to enlarge the access points.
Left, a Hole in the Mortar of the SHU’s Recreation Yard Wall, Right, Signs of Degraded Mortar on the SHU’s Recreation
Yard Wall
Source: OIG, April 2024
Relevant Prior OIG Work and Related Recommendations: Infrastructure
In May 2023, the OIG reported that BOP institutions had a large and growing list of unfunded modernization and
repair needs and that the BOP was unable to address these needs because it lacked a strategy to do so. Further, we
found that the BOP had historically failed to request funding to address its infrastructure needs.
To address this issue, the OIG recommended that the BOP develop an infrastructure strategy to increase the overall
effectiveness of facilities management and to develop and implement key performance indicators to track whether
the BOP is meeting its infrastructure goals. As of the publication of this report on FMC Devens, these
recommendations remain open.
See Appendix 2, Item XV, for more information about this report.
34
C.Agnello SE 0052
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 56 of 569 PageID #:
250
Conclusion and Recommendations
Conclusion
Our unannounced inspection at FMC Devens identified several serious issues related to staffing, inmate
healthcare quality, failure to complete rounds, infrastructure, inmate programming, and radio system
deficiencies. Most significantly, substantial shortages of Correctional Officers and healthcare employees—
which is an issue at many BOP institutions but raises particularly serious concerns at a medical institution—
have created widespread and troubling operational challenges at FMC Devens that substantially affect the
health, welfare, and safety of employees and inmates.
Particularly concerning, we found that FMC Devens’s Correctional Services Department had only 161 of
201 authorized positions filled (80 percent) and the Health Services Department had only 113 of 149
positions filled (about 76 percent) at the time of our inspection. Also concerning, during the on-site portion
of our inspection and shortly thereafter, the medical institution had 1 physician and the Clinical Director (who
is also a physician) to manage the care of the entire inmate population (approximately 941 inmates): 2 of the
institution’s 6 physicians were on extended leave without pay and 3 other physician positions were vacant.
The Clinical Director, who leads the provision of preventive health services and provides standing orders for
nurses, retired in June 2024; the position remained vacant as of October 5, leaving the FMC without this
critical medical role filled and only one physician at the institution to provide daily patient care. Other
vacancies within the Health Services Department included approximately half of the institution’s pharmacy
positions, approximately a quarter of its nursing positions, and its Chief Dental Officer and Deputy Chief
Psychologist positions. Only 20 of 33 positions (61 percent) in the Psychology Services Department were
filled. We are concerned that the staffing crisis at FMC Devens has cascading effects on its ability to care for
its inmates and limits the quality and quantity of medical services it can provide, including for inmates who
were transferred there expressly for its specific medical programs.
We also identified concerns related to the quality of healthcare provided to inmates, including potentially
dangerous medication distribution practices, lack of preventive healthcare screening, inappropriate
placement of inmates in the Memory Disorder Unit (MDU), insufficient oversight of healthcare provider
credential files, and inconsistent processes for requesting and accessing care. Specifically, we observed BOP
employees providing buprenorphine and naloxone to inmates at the Camp during the routine morning
medication administration, along with other inmates receiving daily medications, rather than in separate pill
lines. The employees also did not directly supervise inmates who received buprenorphine and naloxone for
the duration of the medication administration and consumption and did not conduct mouth checks before
or after administration to ensure that diversion did not occur, which presents a diversion risk. We also
found that 57 outside medical appointments that had been ordered for inmates were an average of 53 days
overdue from being scheduled at the time of our inspection due to outside medical providers canceling
appointments and a lack of employees at FMC Devens to escort inmates to scheduled appointments while
maintaining coverage of necessary posts at the institution.
We were also concerned to find that FMC Devens lacked oversight of its contracted company that manages
outside medical records, which caused the delayed receipt of outside medical care records following an
inmate’s visit to an outside physician and resulted in a significant discrepancy between the number of
pending outside medical records that the contracted company indicated it needed to send to FMC Devens
35
C.Agnello SE 0053
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 57 of 569 PageID #:
251
and the number of outside medical records that FMC Devens was waiting to receive. After an outside
medical visit or hospital stay is complete, the company is responsible for securing the inmate’s medical
records and, pursuant to the contract, submitting the records to FMC Devens within 10 business days of the
medical appointment or hospital discharge. We believe that the lack of oversight of outside medical records
could lead to fragmented inmate care and a lack of prompt follow-up care by the institution that could
exacerbate conditions that inmates were sent to outside providers to address.
Subsequently, we found inconsistencies regarding both inmates’ access to medical care and routine
screening of inmates over age 50 for preventive healthcare and cognitive impairment. There appeared to
be inconsistency in how FMC Devens nursing employees determined what constituted a need for sick call
and how that need was tracked. The inconsistency in practice and procedure may limit an inmate’s ability to
be seen and receive medication in a timely manner, which could negatively affect their overall health.
Additionally, we reviewed the medical records of 21 inmates over age 50 to determine whether they were
receiving preventive healthcare screenings and found that only 48 percent (10 of 21) of the inmates had
received a preventive health screening and none of the 21 inmates over age 50 had received a cognitive
impairment screening as part of their preventive healthcare during the previous year. We also determined
that not all inmates with a diabetes diagnosis were tested within required BOP guidelines and not all
healthcare provider credential files were verified as directed by BOP policy. Further, we found that a
quarter of the inmates were not appropriately housed in the MDU, the BOP’s only unit designed specifically
for inmates with dementia. Finally, the OIG found that some inmates serving as medical companions were
not eligible to participate in the program and some performed duties that were both outside the scope of
the program and prohibited by the BOP. The combination of these concerns carries multiple risks for the
institution’s ability to provide adequate, continuous, and follow-up care to inmates.
Further, we identified two issues concerning the institution’s safety and security. First, Correctional Officers
failed to complete about half of the required inmate-monitoring rounds in the housing units that hold
vulnerable inmates at the highest medical and mental health care levels (the MDU, hospital unit, and
transitional mental health step-down unit). This is notable because inmates housed in these units pose an
increased risk for medical-related emergencies, self-harm, and suicide. Second, we found multiple
deficiencies in the institution’s radio system, including “dead zones” where employee radios do not receive
radio signals, namely the hospital areas, and we discovered that some radios were beyond their serviceable
dates, rendering them outdated. Nonworking radios impede employees’ response to medical and
nonmedical emergencies, thus jeopardizing inmates’ and employees’ safety.
We also noted concerning findings pertaining to the lack of sufficient inmate programming. Namely,
because of staffing shortages, many psychology and education-based programs offered to inmates have
large waitlists, with over 100 inmates, and only 1 skills-based vocational program was offered to inmates at
the time of our inspection. Moreover, the one vocational training program had only 10 slots available and a
waitlist of 70 inmates. Additionally, the institution’s LifeSkills Laboratory, a space designed for inmates with
serious mental illnesses to practice routine skills—which received $150,000 in FIRST STEP Act funds—had yet
to be used for programming since its construction 3 years prior to our inspection.
Lastly, FMC Devens had serious infrastructure issues, with many unfunded repair projects, including roof
repairs and replacement of cooling and heating systems, which it estimated would cost $15 million. The OIG
noted the effects of water intrusion throughout the institution, including within housing units, employee
36
C.Agnello SE 0054
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 58 of 569 PageID #:
252
offices, and rooms with optometry and dialysis equipment. If the repairs are not made soon, equipment and
infrastructure failure could exacerbate repair costs and negatively affect inmates’ conditions of confinement.
Recommendations
To ensure effective operations at FMC Devens and safe conditions of confinement for the inmates housed
there, we recommend that the BOP:
1. Ensure that FMC Devens Executive Leadership and the Central Office’s Human Resource
Management Division discuss the staffing projection tool methodology and how it compares with
FMC Devens Executive Leadership’s understanding of its current and potential future mission needs
to ensure greater alignment between stakeholder staffing projections.
2. Ensure that FMC Devens follows BOP guidance for buprenorphine and naloxone administration and
observation and that all FMC Devens employees who administer medication receive training on BOP
guidance and policies for medication administration.
3. Implement a plan to address the medical record backlog at FMC Devens.
4. Ensure that FMC Devens develops a consistent and accurate medical record tracking procedure with
the contracted company that includes regular and recurring reconciliation of outside inmate medical
records between FMC Devens and the contracted company.
5. Ensure that FMC Devens follows the BOP Patient Care Policy for sick call and provides training to all
FMC Devens Health Services Department employees on the policy, as well as on FMC Devens sick
call procedures.
6. Ensure that FMC Devens follows the BOP’s Clinical Practice Guidelines for Preventive Healthcare
Screening to establish a local preventive healthcare program and utilize all members of the
healthcare team in preventive healthcare.
7. Ensure that all FMC Devens inmates over age 50 are receiving preventive healthcare screenings,
including cognitive impairment screening.
8. Ensure that FMC Devens verifies the credential files of all providers prior to allowing them to
administer care to inmates, and ensure that FMC Devens completes peer reviews in accordance with
BOP policy.
9. Ensure that inmates admitted to and housed in the Memory Disorder Unit are appropriately placed
in accordance with FMC Devens’s established criteria.
10. Ensure that FMC Devens adheres to BOP policy on medical inmate companion screening and hiring
and that FMC Devens employees screening and hiring these companions are trained on the policies
and procedures.
37
C.Agnello SE 0055
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 59 of 569 PageID #:
253
11. Ensure that FMC Devens evaluates the roles and responsibilities of medical inmate companions to
ensure that they are not performing duties outside the scope of the inmate companion program.
38
C.Agnello SE 0056
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 60 of 569 PageID #:
254
Appendix 1: Purpose, Scope, and Methodology
Standards
The DOJ OIG conducted this inspection in accordance with the Council of the Inspectors General on Integrity
and Efficiency’s Quality Standards for Inspection and Evaluation (December 2020).
Purpose and Scope
The OIG has determined that it can enhance the effectiveness of its oversight, as well as its ability to alert
the BOP of concerns, by conducting short-notice and unannounced inspections of BOP facilities, as
appropriate. Pursuant to the OIG’s planned procedures for initiating an inspection, which we had previously
shared with the BOP, the OIG notified FMC Devens at approximately 8 a.m. on April 22, 2024, that it would
be initiating an inspection beginning at noon that day. The OIG team, which consisted of 10 OIG employees
and 3 medical subject matter experts contracted by the OIG, conducted the on-site inspection Monday,
April 22, through Friday, April 26, 2024. The focus of our inspection was the state of institution operations at
the time of our inspection; although, for certain portions of our analysis, our scope included roughly the
year that preceded our inspection, beginning around April 2023.
We selected FMC Devens as the site of our fifth inspection to better understand and assess the conditions of
confinement for male inmates at a Federal Medical Center. The scope of this inspection did not include
specialized testing to definitively determine, for example, the potential presence of mold or other hazardous
substances.
Inspection Methodology
To better understand FMC Devens’s operations, we toured the institution, interviewed inmates and
employees, and reviewed its operational records.
Observations
We toured the interior and exterior of the administrative-security institution and its adjacent minimum-
security prison camp, including general population inmate housing units; Psychology Services Department
housing units; Health Services Department housing units; the Special Housing Units; Health Services
Department spaces; front lobby employee entrances and screening areas; programming areas used by the
Psychology, Education, and Recreation Departments; the mail room; the commissary; laundry areas; the
evidence storage area; the visitation room; inmate intake and screening areas; Facilities Department areas;
food storage warehouses; and food preparation and dining areas.
We also reviewed security camera footage, as well as the functionality of the security camera system.
Further, we tested ambient temperatures throughout the institution, as well as the functionality of showers,
sinks, and toilets in inmate housing areas.
39
C.Agnello SE 0057
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 61 of 569 PageID #:
255
Interviews
We conducted on-site interviews with FMC Devens inmates who were housed in the general population and
medical and mental health care units, as well as on-site interviews with institution employees. Employees
we interviewed included the Warden; Associate Wardens, one of whom serves as the institution’s Prison
Rape Elimination Act Coordinator; supervisory and nonsupervisory Correctional Officers; healthcare
providers, managers, and employees; case managers; psychologists; food service employees; and
employees responsible for institution safety, facilities management, human resources, and the trust fund
program. Following our on-site work at FMC Devens, we conducted virtual follow-up interviews with select
FMC Devens employees and select employees at the BOP’s Central Office, as well as with the institution’s
contracted comprehensive medical services company.
General Document Review and Analysis
We reviewed FMC Devens records related to facilities management, staffing levels, use of overtime and
augmentation, use of restrictive housing, provision of inmate healthcare, inmate mental healthcare, food
service, inmate discipline, employee misconduct, sexual abuse reporting and tracking, inmate programming,
and FIRST STEP Act implementation.
Healthcare-related Review and Analysis
We reviewed FMC Devens’s operational documentation related to the provision, access, and quality of
inmate medical and mental healthcare services provided. Specifically, our review included the
implementation of the BOP’s Clinical Practice Guidelines in areas of preventive healthcare screening,
cognitive impairment screening, tuberculosis screening, medication administration, and management of
diabetes; procedures for inmate placement in medical and mental healthcare housing units; management
of inmate medical records and requests for care; scheduling of specialty appointments for medical services
offered on site and in the community; and healthcare staff credentials, including licensure requirements,
privileges, and practice agreements. Additionally, we conducted several case studies on inmate mortalities
and continuity of care concerns.
External Subject Matter Experts Assisting the OIG
To assist the OIG in its efforts to assess the provision of healthcare to FMC Devens inmates, the OIG
contracted the services of three healthcare subject matter experts: one physician and two registered
nurses.
40
C.Agnello SE 0058
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 62 of 569 PageID #:
256
Appendix 2: DOJ OIG and Other Oversight Agency Related Work
I. For the FCI Waseca inspection report, see DOJ OIG, Inspection of the Federal Bureau of Prisons’ Federal
Correctional Institution Waseca, Evaluation and Inspections (E&I) Report 23-068 (May 2023),
oig.justice.gov/reports/inspection-federal-bureau-prisons-federal-correctional-institution-waseca.
II. For the FCI Tallahassee inspection report, see DOJ OIG, Inspection of the Federal Bureau of Prisons’
Federal Correctional Institution Tallahassee, E&I Report 24-005 (November 2023), oig.justice.gov/
reports/inspection-federal-bureau-prisons-federal-correctional-institution-tallahassee.
III. For the FCI Sheridan inspection report, see DOJ OIG, Inspection of Federal Bureau of Prisons’ Federal
Correctional Institution Sheridan, E&I Report 24-070 (May 2024), oig.justice.gov/reports/inspection-
federal-bureau-prisons-federal-correctional-institution-sheridan.
IV. For the FCI Lewisburg inspection report, see DOJ OIG, Inspection of Federal Bureau of Prisons’ Federal
Correctional Institution Lewisburg, E&I Report 24-113 (September 2024), oig.justice.gov/reports/
inspection-federal-bureau-prisons-federal-correctional-institution-lewisburg.
V. For prior Government Accountability Office (GAO) reporting on BOP staffing levels, see GAO, Bureau of
Prisons: Opportunities Exist to Better Analyze Staffing Data and Improve Employee Wellness Programs,
GAO Report 21-123 (February 2021), gao.gov/products/gao-21-123 (accessed November 6, 2024).
VI. For prior OIG reporting on BOP inmate deaths in custody, see DOJ OIG, Evaluation of Issues Surrounding
Inmate Deaths in Federal Bureau of Prisons Institutions, E&I Report 24-041 (February 2024),
oig.justice.gov/reports/evaluation-issues-surrounding-inmate-deaths-federal-bureau-prisons-institutions.
VII. For prior OIG reporting on the BOP’s use of overtime, see DOJ OIG, Management Advisory: Analysis of
the Federal Bureau of Prisons’ Fiscal Year 2019 Overtime Hours and Costs, Audit Report 21-011
(December 2020), oig.justice.gov/reports/management-advisory-analysis-federal-bureau-prisons-fiscal-
year-2019-overtime-hours-and.
VIII. For additional prior OIG reporting on the BOP’s staffing challenges, see DOJ OIG, Investigation and Review
of the Federal Bureau of Prisons’ Custody, Care, and Supervision of Jeffrey Epstein at the Metropolitan
Correctional Center in New York, New York, Investigations Report 23-085 (June 2023), oig.justice.gov/
reports/investigation-and-review-federal-bureau-prisons-custody-care-and-supervision-jeffrey.
IX. For prior OIG reporting on the insufficiency of the BOP’s security camera systems and contraband
introduction at BOP institutions, see DOJ OIG, Review of the Federal Bureau of Prisons’ Contraband
Interdiction Efforts, E&I Report 16-05 (June 2016), oig.justice.gov/reports/review-federal-bureau-prisons-
contraband-interdiction-efforts.
41
C.Agnello SE 0059
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 63 of 569 PageID #:
257
X. For additional prior OIG reporting on the insufficiency of the BOP’s security camera systems, see DOJ
OIG, Management Advisory Memorandum: Notification of Needed Upgrades to the Federal Bureau of
Prisons’ Security Camera System, E&I Report 22-001 (October 2021), oig.justice.gov/reports/management-
advisory-memorandum-notification-needed-upgrades-federal-bureau-prisons-security.
XI. For prior OIG reporting on the BOP’s medical staffing challenges, see DOJ OIG, Review of the Federal
Bureau of Prisons’ Medical Staffing Challenges, E&I Report 16-02 (March 2016), oig.justice.gov/reports/
review-federal-bureau-prisons-medical-staffing-challenges.
XII. For additional prior OIG reporting on the BOP’s medical staffing challenges, see Pandemic Response
Accountability Committee, Review of Personnel Shortages in Federal Health Care Programs During the
COVID-19 Pandemic (September 2023), oversight.gov/sites/default/ files/oig-reports/PRAC/healthcare-
staffing-shortages-report.pdf (accessed November 6, 2024).
XIII. For prior OIG reporting on the BOP’s scheduling of outside medical visits, see DOJ OIG, Audit of the
Federal Bureau of Prisons Comprehensive Medical Services Contracts Awarded to the University of
Massachusetts Medical School, Audit Report 22-052 (March 2022), oig.justice.gov/reports/audit-federal-
bureau-prisons-comprehensive-medical-services-contracts-awarded-university.
XIV. For prior OIG reporting on BOP staffing levels, see DOJ OIG, Limited-Scope Review of the Federal Bureau
of Prisons’ Strategies to Identify, Communicate, and Remedy Operational Issues, E&I Report 23-065 (May
2023), oig.justice.gov/reports/limited-scope-reviewfederal-bureau-prisons-strategies-identify-
communicate-and-remedy.
XV. For prior OIG reporting on the BOP’s infrastructure management challenges, see DOJ OIG, The Federal
Bureau of Prisons’ Efforts to Maintain and Construct Institutions, Audit Report 23-064 (May 2023),
oig.justice.gov/reports/federal-bureau-prisons-efforts-maintain-and-construct-institutions.
XVI. For prior reporting on the BOP’s aging inmate population, see DOJ OIG, Review of the Impact of an Aging
Inmate Population on the Federal Bureau of Prisons, E&I Report 15-05 (May 2015), oig.justice.gov/
reports/review-impact-aging-inmate-population-federal-bureau-prisons.
42
C.Agnello SE 0060
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 64 of 569 PageID #:
258
Appendix 3: BOP Policies and Clinical Guidance Cited
Topic Discussed in Report Relevant Program Statement Link
5538.08
www.bop.gov/policy/progstat/5538.08.pdf
Escorted Trips Escorted Trips
(accessed July 8, 2024)
April 8, 2024
6027.02
Health Care Provider Credential www.bop.gov/policy/progstat/6027_002.pdf
Credential Verification
Verification, Privileges, and Practice
and Peer Review (accessed May 8, 2024)
Agreement Program
October 12, 2016
6360.02
www.bop.gov/policy/progstat/6360_002.pdf
Pharmacy Services Pharmacy Services
(accessed May 22, 2024)
October 24, 2024
Preventive Health Care, www.bop.gov/resources/pdfs/preventive_heal
Colorectal Cancer, and Preventive Health Care Screening
th_care_cg_2022.pdf
Cognitive Impairment July 2022
Screening (accessed April 3, 2024)
www.bop.gov/resources/pdfs/201703_diabetes.
Management of Diabetes
Management of Diabetes pdf
March 2017
(accessed April 12, 2024)
5310.17
www.bop.gov/policy/progstat/5310_017.pdf
Psychology Services Psychology Services Manual
(accessed July 8, 2024)
August 25, 2016
5335.01
Secure Mental Health www.bop.gov/policy/progstat/5335.01.pdf
Secure Mental Health Units
Units (accessed May 7, 2024)
January 23, 2023
5270.12
www.bop.gov/policy/progstat/5270.012.pdf
Special Housing Units Special Housing Units
(accessed March 7, 2024)
March 5, 2024
5324.10
www.bop.gov/policy/progstat/5324_010.pdf
Sex Offender Programs Sex Offender Programs
(accessed July 25, 2024)
February 15, 2013
6031.05
www.bop.gov/policy/progstat/6031.05.pdf
Patient Care Patient Care
(accessed July 30, 2024)
May 14, 2024
43
C.Agnello SE 0061
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 65 of 569 PageID #:
259
5394.01
Certification and Civil
Certification and Civil Commitment www.bop.gov/policy/progstat/5394.01.pdf
Commitment of Sexually
of Sexually Dangerous Persons (accessed September 30, 2024)
Dangerous Persons
February 1, 2016
BOP Opioid Use Disorder BOP Opioid Use Disorder Guidance Not applicable. The BOP does not make this
Guidance January 1, 2024 policy publicly available.
44
C.Agnello SE 0062
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 66 of 569 PageID #:
260
Appendix 4: The BOP’s Response to the Draft Report
U. S. Department of Justice
Federal Bureau of Prisons
Central Office
Office of theDirector Washington, DC 20534
December 6, 2024
MEMORANDUM FOR JAN HAMM, CHIEF INSPECTOR,
EVALUATIONS AND INSPECTIONS
FROM: Colette S. Peters, Director
SUBJECT: Response to the Office of Inspector General's(OIG) Draft Report.
lils]ection ofthe Federal Bureau of Prisons' Federal Medical Center
Devens., Assignment Number A-2024-004
The Federal Bureau ofPrisons (FBOP) appreciates the opportunityto formally respondto the Officeof
the Inspector General's (OIG) draft report: Inspection of the Federal Bureau of Prisons' Federal
Medical CenterDevens (the Report). Thank you for your thorough and thoughtful evaluation.
The FBOP appreciates the level of attentionand detail that went into the Report. FBOP has taken
Agency-wide action to address the staffing and infrastructure challenges identified in this report. In
addition, the FederalMedical Center (FMC)Devens is actively addressing the recommendations from
the Report
Agency-wideActions to Address Staffing and Infrastructure Challenges
This inspection report is one of several that have highlighted FBOP' s staffing shortages and
infrastructure challenges. Th.e FBOP agrees that staffing shortages and crumbling infrastructure
can create dangerous conditions in our institutions and compromise the health and security of
FBOP employees and those in our care and custody.. Addressing these challenges are among our
top priorities. To that end, we are working closely with the Department to make the case for
additional pay authorities and funding to ensure that we can fully effectuate our mission to safely
house adults in custody (AIC's) and prepare them for successful reentry into our communities.
Recently, the Department shared with Congress A funding proposal to address critical safety
needs across the federal prison svstem. ("'Funding Proposal"). That document sets out a 5-year
plan to address FBOP' s staffing and modernization and repair (M&R) challenges. The key
elements of that plan are:
45
C.Agnello SE 0063
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 67 of 569 PageID #:
261
• Funding to implement a Special Salary Rate (SSR). FBOP has been workng closely with
DOJ and the Office of Personnel Management (OPM) to obtain approval for a nationwide
SSR for corrections officers and nurses. We anticipate a decision from OPM in early
2025. However, FBOP will be unable to implement an SSR without additional funding.
Toe Funding Proposal seeks $1,000,730,000 over the next five years to cover SSRs for
the FBOP' s current authorized levels of corrections officers and covered nurses.
• Additional funding and positions to increase CO and nurse staffing levels. The Funding
Plan seeks an increase of 4,500 CO positions and 200 nurses along with $1,570,000,000
to fund those positions. The increase in positions is based on projections from the newly
launched Automated Staffing Tool.
• Additional funding of$1,835,861,000 over five years to address critical M&R needs.
Toe proposal is based on a Five-Year Capital Investment Plan (Capital Investment Plan)
that FBOP developed in collaboration with the Justice Management Division (JMD) and
the Office of Management and Budget (OMB).
As FBOP works to obtain adddional pay authorities and resources, it continues to make progress
on recruitment, retention, and M&R
Recruitment and Retention
As of mid-September 2024, FBOP had a net increase of almost 900 employees since January 1,
2024. In Fiscal Year (FY) 2024, FBOP increased new hires by approximately 14 percent and
decreased separations by 19 percent. Additionally, as of pay period 22, there are 25 FBOP
institutions with CO staffing levels at or above 95%.
Our success has extended to FSA and medical positions, FSA onboard positions nearly doubled
in FY 2024. FBOP hired 331 new FSA positions, increasing total onboard from 338 positions at
the end of FY 2023 to 669 positions at the end of FY 2024. In addition, FBOP achieved a 5.88%
year-over-year increase in registered nurse hires and a 28.96% decrease in nurse vacancies
(October 2024 vs October 2023). There was also a year-over-year increase in eligible applicants
for several medical positions, including physician assistant and clinical psychologist.
We attribute our increased staffing levels to several factors, including:
• 2024 hiring initiatives In February 2024, the Director issued a memorandum for Chief
Executive Officers focused on: (1) a renewed commitment to extemal hiring to expand
the applicant pool to the greatest extent possible; (2) authorizing wardens to over hire for
custody, medical, psychology, and FSA positions when an institution had more qualified
applicants than allocated positions; and, (3) establishment of regional team of employees,
determined through an application process, to serve as a "travel response team" to
support institutions with the highest vacancies within their regions.
• Nationwide Direct Hire Authority (DHA) for COs: Direct hire authority offers a
streamlined approach to federal hiring. In May 2024, OPM approved nationwide DHA
for correctional officers. Previously, FBOP had direct hire authority for COs at a few
institutions The nationwideDHA has resulted in a dramatic increase in direct hire
appointments. The FBOP has had 64 2 direct hires appointments inFY 2024 compared to
2
46
C.Agnello SE 0064
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 68 of 569 PageID #:
262
83 in FY 2022 and 196 in FY 2023.
• Ongoing focus by our National Recruitment Office (NRO): NRO continues to focus
recruitment efforts on our most difficult to fill positions, including COs and medical.
Finally, on October 1, 2024, FBOP rolled out its Automated Staffing Tool (AST) The AST,
which is applicable to all employee disciplines, calculates staffing levels. for every kind of
employee at each institution based on it s unique mission and staffing guidel ines. The AST
calculates the optimal number of positions at each institution using standard metrics across the
BOP. While this tool will not solve the staffing crisis, FBOP will use AST data to inform
recruitment and retention efforts and to support Congressional budget requests. (Please see
below for additional information. regarding the AST.)
M&R
FBOP continues to make strides in developing strategic approaches to address its M&R backlog.
As noted above, FBOP worked with DOJ and OMB to develop the Capital lnvestment Plan. The
plan establishes a rationale and timeline for making significant repairs required at institutions
across the Agency. The plan would require $1,8.35,861 ,000 to execute, which is FBOP's
assessment of what it can pract ically accomplish over the next five years. This funding need is
included in the Funding Plan that has already been shared by Congress. In addition, FBOP plans
to use the Capital Investment Plan as the basis for future Congressional budget requests.
The Capital Investment Plan is structured to ensure that all critical needs are systematically
addressed. The plan is categorized into several key repair categories, each focusing on specific
aspects of infrastructure and facility maintenance. By breaking down the repair needs into these
specific categories, the plan aims to methodically tackle each area, ensuring that all necessary
repairsand upgrades are compJeted in a timely and efficient manner. This structured approach
not only addresses immediate repair needs but also supports p lanning for future maintenance,
thereby promoting the long-term sustainability and functionality of the facilities. The
prioritization of the five-year capital improvement plan projects is based on the following
criteria:
• Safety system projects ( e.g., as fire alarm, sprinkler replacement, fire pump, and duress
systems projects). These projects are necessary to create a safe environment for both
employees and AICs.
• Security projects. These projects are necessary to maintain secure institutions to confine
offenders and protect the public.
• Infrastructure projects. These projects ensure maximumefficiency of the FBOP's
physical plants resulting in safe, humane, and secure institutions.
• Bedspace impact projects. These proj ects are crucial to managing the AIC population by
identifying and resolving offline bedspace.
Additionally, in August 2023, the FBOP hired a contractor, Guidehouse, to develop a long-term
strategy to align infrastructure decisions with the FBOP' s mission, including methodologies for
allocating resources using short, medium, and long-range planning goals The contractor has
compJeted three of four deliverables (Current State Assesment; Industry Leading Practices;
Develop M&R Strategic Framework) and is on track to complete the fourth deliverable
3
47
C.Agnello SE 0065
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 69 of 569 PageID #:
263
(Integration of Framework Report) by March 31, 2025. The FBOP anticipates using an
application developed by the contractor in Spring 2025 as the regional priority lists are received
by the Chiefof Resource Management.
Automated Staffing Tool (AST)
The FBOP provides the following general response regarding the AST and the steps that it is
taking to ensure that AST accurately projects institution staffing needs.
Criteria and Validadon. The selection and weighting of criteria and sub-criteria for the AST
calculations are determined by a three-part methodology. First, a contractor hired by FBOP
identified the drivers that have the most impact on FBOP' s staffing needs, using methodologies
and best practices from the industry and similar federal agencies. Second, FBOP's executive-
approved staffing guidelines were analyzed, in conjunction withinterviews with SMEs within
these disciplines. The expertise and on-the-ground experience of the SMEs guide the AST
calculations by identifying and appropriately weighting the most relevant criteria. For example,
in custody, these criteria were determined to be age and size of the institution, distance to the
hospital, mental health and medical care level, UNICOR presence, security level, facility type,
and bed audit capacity.
External validation and independent research were conducted through similar agencies to affirm
the validity of the criteria and align them with current industry standards, while identifying
emerging trends that may warrant adjustments. In fact, over 400 subject matter experts were
consulted in developing the AST This comprehensive approach results in the AST providing
credible and justified data-driven insights. Importantly, FBOP continues to wolk with
institutions including FMC Devens, to reconcile any disparate staffing projections. (See below
FBOP response to Recommendation 1).
Calculation of medical positions. The AST projects medical positions needed to provide
appropriate levels of medical care to those in our care and custody. The projections are based on
patient care needs. As discussed during the FBOP' s demonstration of the AST for OIG earlier
this year, square footage of an institution ( e.g . to accommodate office space) is not a factor in
determining needed Health Services positions. FBOP Executive Leadership recognizes that
additional office space will be needed at some institutions to support the AST's projections. We
are evaluating the use of modular buildings or other cost-efficient options to accommodate office
space needs for additional personnel.
Institution input .i nto AST development.FBOP has provided all institutions and regions with
multiple opportunities to discuss the AST's projections and methodology. Beginning in June
2023, with the rollout of eachdepartment, all institutions were given the opportunity to provide
input and concerns regarding the position recommendations for their institution. Regarding the
Correctional Services Department, HRMD participated in regional calls organized by the
contractor to discuss methodology and familiarize users with the AST. In addition, all wardens
and institution Human Resource Managers have user access to the AST and have been
encouraged to raise questions directly to the contractor.
4
48
C.Agnello SE 0066
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 70 of 569 PageID #:
264
Further, at the Central Office level, each division designated one or more subject matter experts
to work directly with the contractor to provide input into the appropriate criteria for departments
under their area of responsibilyty. Each Assistant Director reviewed and confirmed the criteria
prior to adopting it for use in the AST position calculations.
In August 2024, HRMD asked all Wardens to complete a survey to provide specific input on the
AST position recommendations. Each Wardens was asked to confirmor provide concerns with
the AST recommendations for their institutions. A significant majority of wardens agreed with
the proj ections for their respective institution. HRMD has compiled survey results and shared
them with each Regional Director to confirm any issues noted by institution leadership.
Although the goal of the AST is to standardize the methodology for calculating recommended
positions, there wi.11 inevitably be outliers to the global criteria that will require individualized
solutions. HRMD and the contractor have been working with wardens to ensure that they
understand the AST's methodology and resolve questions and concerns to the extent possible.
We note that the AST is designed to address the need for approved permanent institution staffing
levels.
Action Steps Taken bv Fl\IC DevensSince the Site Inspection
Importantly, since the time of the FMC Devens site inspection, FMC Devens has taken the
below-noted actions.
Staffing
FMCDevens has hired several new employees:
• Doctors: Hired one additional Medical Doctor (MD), with two other MD candidates in
the hiring process.
• Psychiatrist: Hired psychiatrist who is scheduled to be on site at FMC Devens during
pay period 24.
• Advanced Care Level Psychologists: Hired three Advanced Care Level Psychologists
at FMC Devens. They started at FMC Devens on August 11, 2024, October 6, 2024, and
N ove:mber 17, 2024.
• Physical Therapy employees: Two additional physical therapy employees started on
N ovember 3, 2024.
• Treatment Specialist: A LifeSkills Lab Treatment Specialist started at FMC Devens on
N ove:mber 3, 2024. The Treatment Specialist is receiving training to initiate
programming, and assessments have begun for AICs who were referred for programming
to determine levels of support each AIC will need.
• Corrections Officers: FMC Devens has hired 12 COs hired since April 2024. Six (6)
additional COs are scheduled to start on December 1, 2024.
Programming
Regarding OIG's concern that staffing shortages have affected FMC Devens' ability to offer
5
49
C.Agnello SE 0067
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 71 of 569 PageID #:
265
programming, FMC Devens has noted that current staffing levels in the FMC Devens Education
Department does not limit FMC Devens from offering GED courses; nor do staffing levels limit
provision of CDL programming at the camp. Devens had 14 GED completions in FY 2024 and
already has six in FY 2025. FMC Devens is establishing an MOU with the Massachusetts
Registry of Motor V ehicles in order to begin the CDL program; staffing shortages are not
precluding the program.
fmcDevens Psychology Services maintains a comprehensive approach to AIC care.
Psychology Services prioritizes programming for inmates with higher mental health care needs,
while also providingresources and programs for those with lower mental health care levels.
Furthermore, as noted above, FMC Devens has hired three new psychologists, including one
Staff Psychologist who offers evidence-based practice groups and First Step Act (FSA) groups to
individuals with lower mental health care leveJs.
The FMC Devens Education Department is working to bolster meaningful and marketable skill
programming at the camp. The FMC Devens Supervisor of Education (SOE) has directed one
employee in the coming calendar year to specifically address needs at the camp.. This employee
will oversee the literacy program. as well as the newly established Dog Training program. This
dog training program will bring an opportunity for AICs to earn Dog Training Apprenticeships,
which is a nationally recognized certificate offered by the Department of Labor. The SOE has
also been working closely with Mount Wachusett College to bring the Pell Grant to Devens at
the end of calendar year 2025, with the goaJ of offering college course work both inside the
institution and at the camp. This partnership will aJso open the opportunity to partner with the
college on vocational college credit hour earning programs.
Safety & Security
1n the Report, OIG noted a concern that employee radios did not receive a signal in some parts of
the institution, namely the hospital and areas below ground, and radios were beyond their
serviceable dates, rendering many radios unrepairable.
Since the time of OIG's site inspection, a repeater for the radio system at FMC Devens was
repaired in May 2024. FMC Devens currently reports no "dead zones" or issues with the radio
system. Moreover, FMC Devens is scheduled to receive new radios in FY 2025.
The Report also states that per post orders, "CorrectionalOfficers must complete irregularlytimed
rounds within each 30-minute block oftime while working a post in a housing unit." However, 0IG
found that "collectivelyonly half the required rounds (53 percent) were completed in the [Memory
Disorder Unit] MDU, hospital unit, and transitional mental health step--dmlin unit, leaving vulnerable
inmates unobserved for multiple hours each night''
FMC Devens understands the importance of assuring the welfare of all AICs and employees and
continues to strive to ensure policy is being followed. FMC Devens employees are required to
adhere to current policy requiring that they conduct 30-minute rounds not to exceed 40-minutes
in all areas housing AICs in a continuous lockdown status (such as the Special Housing Unit, JA
andJB and all housing units inN-building.) Employees assigned to the P building (hospital) are
6
50
C.Agnello SE 0068
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 72 of 569 PageID #:
266
required to conduct irregular rounds as those units are not in a continuous lock down status.
Currently, FMC Devens leadership is conducting periodic reviews of video footage from. the
Special Housing Unit to ensure adherence to policy requirements. ln addition, FMC Devens
leadership will conduct periodic reviews of additional video footage from random housing unit s
on random. shifts. Further, FMC Devens leadership is sending reminders to employees about the
importance of conducting rounds, as well as the requirement to read, be familiar with, and sign
the post orders which detail all the required duties, including conducting rounds.
Infrastructure
In the Report, OIGfound that FMC Devens has :several unfunded major infrastructure and
equipment repair projects that present safety and security issues , that many facility systems are
approaching the end of their projected lifespan, and that the roofs need repair.
Shortly after the site inspection, shower stall flooring in medical housing units were replaced
with abrasive flooring paint, and mats were repositioned under shower chairs in the shower
stalls. Additionally, FB0P has includedthe following FMC Devens M&R projects in its Capital
Investment Plan. The FY 2024 replacement generator project is funded. The remaining M&R
proj ects are awaiting sufficient funding.
Estimated Months to
Fiscal Project Project Total Project Complete
Year Region Name City State Category Description Cost $000's Estimate
Replace
Em ergency
FMC Utility Sta ndby
FY24 NER Devens Ayer MA Infrastructure Gen erator $1,008 18
FMC
FY29 NER Devens Ayer MA Roofing Replace Roofs $3,900 18
FMC
FY29 NER Devens Ayer MA Roofin g Repair Roofs $504 18
FMC Genera l
FY29 NER Devens Ayer MA Improvement Repair Asphalt $2,100 12
FMC Replace Control
FY29 NER Devens Ayer MA Security PLC $500 12
FMC Utllity Replace Boiler
FY29 NER Devens Ayer MA Infrastructurere Burners $3,000 12
FMC Replace Cooling
FY30 NER Devens Ayer MA Cli m ate Cont rol Tower $1,575 18
In addition to the above, FBOP offers the following responses to the Report Recommendations.
R ecommendation 1: Ensure that FMC Devens Executive L eadership and the Central
Office'sHuman Resources Management Division discuss the staffing projectiontool
methodology and how it compares withFMC Devens Executive Leadership's
understanding of its current ancl potentilal futuremissionneeds to ensure greater alignment
7
51
C.Agnello SE 0069
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 73 of 569 PageID #:
267
between stakeholder staffing proj ections .
FBOP Response: FBOP concurs with this recommendation. FMC Devens Executive
Leadership is continuing ongoing communications with FBOP's Human Resource Management
Division (HRMD) regarding the AST methodology and the proper staffing leveJs for FMC
Devens.
The warden at FMC Devens completed the AST survey in August 2024 . In September, FMC
Devens's Executive Team, Regional Office Executive leadership, and the contract or discussed
the staffing projection tool methodology.
The feedback from Executive Leadership at FMC Devens included the following:
• Number of authorizedCorrectional Services positions (201) should remain at current
levels. This request was supported by new information related to the closure of a local
hospital and the resulting need for additional positions to support hospital trips.
• Seven additional positions for Psychology.
• Decrease of 123 positions for Health Services.
• Agreement with AST projections for all other disciplines.
HRMD is continuing conversations with FMC Devens to ensure that it understands the
methodology for the recommendations. In addition, HRMD and divisional SMEs will continue
to engage with the institution and regional leadership to address the feedback above as well as
any additional criteria or outlier issues that can be addressed for FMC Devens.
Recommendation 2: Ensure that FMC Devens follows BOP guidance for buprenorphine
and naloxoneadministration and observation and that all FMC Devens employees who
administer medication receive training on BOP guidance ancl policies for medication
administration.
FBOP Response: FBOP concurs with this recommendation. Since the inspection, FMC Devens
has ensured rou tine observation by Nurse Supervisors of the process for buprenorphine and
oaloxone administration and will continue to monitor the process closely and correct as needed.
Guidance was sent via email to all Devens Nursing Employees on April 26, 2024, regarding this
medication administration at the camp facility. On May 2, 2024, FMC Devens Health Services
Supervisory Clinical Nurse conducted an observational review of the FMC Devens camp MAT
pill line. This review resulted in the creation of a document articulating issues and corrective
actions for nursing related items on May 6, 2024. Specifically, it was noted in the review that not
all nurses were conducting the MAT line and morning pill line separately and that there was not
a second person available to observe during MAT administration. The review recommended that
re-training be completed for nursing staff regarding the separation of MAT administration with
the pill line. Additionally, the nurse manager communicated with the captain to require a camp
officer to observe during the MAT pill line, including conducting mouth checks.
Subsequently, another email was sent on November 13, 2024, by the Acting Director of Nursing
52
C.Agnello SE 0070
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 74 of 569 PageID #:
268
at FMC Devens, again reminding all FMC Devens nursing employees of the relevant guidance
and requirements. Additionally, all employees who administer medication will receive additional
training durin g FMC Devens next Health Services Monthly meeting in December 2024.
Recommendation 3: Implement a plan to address the medical record backlog at FM C
Devens.
FBOP Response: FBOP concurs with this rerommendation, and FMC Devens Health Services
Leadership has reconciled their list of pending reports and has ensured that all reports received
from the comprehensiv e contract have been scanned into the electronic medical record and
removed from the pending report list FMC Devens continues to provide a monthly list of
pending reports to the comprehensive contract representatives and will engage contract
representatives more frequently to seek any time-sensitiv e reports .
FMC Devens Health Services Leadership and FMC Devens Contracting Specialists will continue
to meet monthly and as needed to communicate expectations related to any past due pending
reports. The contract representatives will complete a weekly reconciliation with FMC medical
records staff until any pending reports are received.
Recommendation 4: Ensurethat FMC Devens develops a consistent and accurate medical
r ecor d tracking procedure with the contracted company that includes regular and
recurring reconciliation of outside inmate medical recor ds between FMC Devens and the
contracted company.
FBOP Response: FBOP concurs with this recommendation.. As stated in response to
Recommendation 3, above, FMC Devens continues to provide a monthly list of pending reports
to the comprehensive contract representatives and wi.11 engage contract representatives more
frequently to :seek any time-sensit ive reports. FMC Devens Health Services Leadership and FMC
Devens Contracting Specialists will continue to meet monthly and as needed to comnnmicate
expectations related to any past due pending reports. The contract representatives wi.11 complete a
w eekly reconciliation with FMC medical records staff until any pending reports are received
Recommendation 5: Ensure that FMC Devens follows the BOP Patient Care Policy for
sick call and provides training to all FMC Devens Health Services Department employees
ou the policy, as well as on FMC Devens sick call procedures.
FBOP Response: FBOP concurs with this recommendation. FMC Devens has already taken
action to implement this recommendation. Since May 2024, nurse supervisors have been present
in the ou tpatient clinic during sick call times to provide on-the-spot corrections to health services
department -employees as needed. Further, on November 21 , the FMC Devens Assistant Health
Services Administrator sent an email to all health services staff on sick call procedures with
specific reminders about sick call procedures and attaching the local procedures document FMC
Devens will provide more educationfor all health services department staff at the next monthly
health services meeting in December 2024.
Additionally, FMC Devens provided training to its nursing employees on the policy and FMC
9
53
C.Agnello SE 0071
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 75 of 569 PageID #:
269
Devens sick call procedures in May 2024, after OIG' s site inspection. Subsequently, the FMC
Devens Supervisory Clinical Nurse directed all FMC Devens nursing employees to require the
following:
• Since July 1, 2024, AICs have been required to sign into a check-in logbook during sick
call, between 7:30 and 8:30 a.m., even if the issue presented is non-sick-call related.
• The logbook must indicate the date, the AIC's last name and register number, and reason
for visit.
• Sick Call Forms have been centrally placed for ease of use, and each AIC must complete
the form prior to being seen.
• Sick Call Forms and the tracking log must be maintained for 60 days.
• Nurses must schedule follow-up appointments for providers using the sick call guidelines
inputting the time and adding the appointment into the scheduler application directly
from their clinical encounter, so that there is a time stamp maintained of appointment
scheduling.
• The charge nurse will review the tracking log before the end of each day and verify that
each entry was either seen the same day, does not require follow-up, or has an
appointment entered into the scheduler, and notates that into the tracking log.
Recommendation 6: Ensure that FMC Devens follows the BO P's Clinical Practice
Guidelines for Preventive Healthcare Screening to establish a local preventive
health
program ancl utilize all members of the healthcare team in preventivehealthcare.
FBOP Response: FBOP concurs with this recommendation. FMC Devens estaiblisheda
collaborative local preventative health program in August 2024 which follows the current
preventative health guidance recommendations in the FBOP' s Clinical Practice Guidelines for
Preventative Healthcare Screening, the United States Preventative Task Force guidance and the
subscription service, UptoDate.
Recommendation 7: Ensure that all FMC Devens inmates over age 50 are receiving
preventivehealthcare screenings,, includingcognitive impairment screening.
FBOP Response: FBOP concurs with this recommendation and notes that during the exit
conference, OIG clarified that this recommendation pertains specifically to all AlCs over age 50
at FMC Devens. As stated in the response to Recommendation 6, FMC Devens established a
collaborative local preventative health program in August 2024 which follows the current
preventative health guidance recommendations for all inmates over age 50 in the FBOP's
Clinical Practice Guidelines for Preventative Healthcare Screening, the United States
Preventative Task Force guidance and the subscription service, UptoDate..
Included in the Standard Operating Procedures for the Implementation of the Preventative Health
Care Clinical Practice Guidelines at FMC Devens, issued August 26, 2024, are requirements for:
• A thorough chart review to determine what tests and evaluations are indicated by the
AIC'sage, sex, and risk factors...
• Interviews of AICs to assess risk factors and recommend/order specific health screens
and interventions.
10
54
C.Agnello SE 0072
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 76 of 569 PageID #:
270
• Instructing AlCs about prevention measures.
• Administering immunizations.
• Referring abnormal results for follow-up to a physician.
• Scheduling AICs for preventative health baseline visits at intake or within the first six
months of incarceration.
• Scheduling periodic visits every three years for AICs under age 50 and annually for those
aged 50 or older.
• Clearly documenting preventative Health Periodic Visits as such.
Recommendation 8: Ensure that FMC Devens verifies the credentialfiles of all providers
prior to allowingthem to administer care to inmates and ensure that FMC Devens.
completes peer reviewsin accordancewithBOP policy.
FBOP Response: FBOP concurs with this recommendation. Currently, FMC Devens verifies
the credential files of all health services employees at FMC Devens, prior to hiring and upon
license renewal. FMC Devens Health Services Leadership, and FBOP Health Services Division
are working together to complete necessary peer reviews and privilegesin accordance with
FBOP's Program Statement 6027.02 Health Care Provider Credential Verification, Privileges,
and Practice Agreement Pro gram.
Regarding two specific types of health services providers, telepsychiatrists and pharmacists:
Any credential files completed by FBOP Health Services Division for telepsychiatry providers
will also be locally maintained at FMC Devens and added to the FMC Devens credentialing
tracker, ensuring that active privileges and peer reviews for telepsychiatry providers are in
accordance with FBOP policy. Additionally, two pharmacist peer reviews at FMC Devens were
submitted in September 2024 and the remaining three are scheduled to be completed and
submitted upon their Collaborative Practice Agreement (CPA) renewal in 2025.
lt is important to note that, in addressing the peer reviews for clinical pharmacistswith a
collaborative practice agreement, past practice and current policy distinguish between providers
working under practice agreements, such as physician assistants and nurse practitioners, and
pharmacist working under a CPA. While some institutions chose to apply the policy to both
types, peer reviews for pharmacists working under collaborative practice agreements had not
been explicitly required in P.S. 6027.02.
However, recognizing the need for clarification, FBOP Central Office Health Services Divisions
issued a memo in February 2024 to clearly define and require peer reviews for all pharmacists
working under a CPA to be completed, and submitted at the time of CPA renewal.
Recommendation 9: Ensure that inmates admitted to and housed in the Memory Disorder
Unit are appropriatelyplaced in accordance withFMC Devens'sestablished criteria.
FBOP Response: FBOP concurs with this recommendation. To ensure that AICs admitted to
and housed in the Memory Disorder Unit (MDU) are appropriately placed, FMC Devens Health
Services Leadership reviewed each MDU resident in May 2024. Additionally, the Regional
Medical Director reviewed ,each MDU resident again during tbe week of November 11, 2024, to
11
55
C.Agnello SE 0073
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 77 of 569 PageID #:
271
ensure that each resident has a diagnosis involving dementia or chronic memory impairment
FMC Devens has a temporary moratorium approved for admissions to the MDU at this time.
FMC Devens Health Services Leadership, with guidance from FBOP Health Services Division,
are in the process of reviewing and revising the established admission criteria to be inclusive of
diagnoses that include dementia and chronic memory impairment as a symptom of the disorder.
Once the admission criteria are revised, the moratorium will be discontinued Further updates
will be provided as that revision occurs.
Recommendation 10: Ensure that FMC Denns adheres to BOP policy on medical inmate
companion screening ancl hiring and that FMC Devensemployeesscreening ancl hiring
these companions aretrained on the policies and procedures.
FBOP Response: FBOP concurs with this recommendation. To ensure adherence to FBOP' s
Program Statement 6010.05Health Services Administration, Section 5 (Inmate HSU Workers),
FMC Devens Nurse Supervisor reviewed the AIC Companion roster during the week of
November 11, 2024. This review resulted in a finding that there were two companions deemed
ineligible and these AICs were terminated from their positionson November 18 and 19, 2024.
Tue Nurse Supervisor responsible for hiring medical inmate companions now ensures that all
medical AIC companions currently meet the eligibility criteria.
Additionally, starting July 2024, the Nurse Manager has sent monthly emails to Nursing Staff
reminding them of the duties and responsibilities of inmate medical companions. Also, in
September 2024, education and training were provided to medical inmate companions and all
FMC Devens employees who supervise inmate companions. Thistraining covered the technical
guidance for the Medical Inmate Companion Program, companion qualifications / eligibility, and
roles and responsibilit ies of inmate companions..
Recommendation 11: Ensure that FMC Devensevaluates the roles and responsibilities of
medical inmate companions to ensure that they are not performing duties outside the scope
of the inmate companion program.
FBO P Response: FBOP concurs with this recommendation. As indicated in the response to
Recommendation 10, FMC Devens Nurse Supervisor reviewed the AIC Companion roster
during the week of November 11, 2024, to ensure adherence to FBOP' s Program Statement
6010.05 Health Services Administration, Section 5 (Inmate HSU Workers}. Additionally,
education and training were provided to medical inmate companions as described in the response
to recommendation 10, above, to ensure that companions do not perform duties outside the scope
of the inmate companion program.
12
56
C.Agnello SE 0074
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 78 of 569 PageID #:
272
Appendix 5: OIG Analysis of the BOP’s Response
The OIG provided a draft of this report to the BOP for its comment. The BOP’s response is included in
Appendix 4 to this report.
In its formal response, the BOP acknowledged the issues identified in this report and described actions that
it has already taken to rectify the findings. The BOP’s response to this report was notably comprehensive in
describing both agency-wide actions it has taken to address long-standing staffing and infrastructure
challenges, as well as institution-level actions that FMC Devens has taken and planned to address each
recommendation. The BOP provided a separate set of responses from FMC Devens (not included in this
appendix) describing those specific actions, along with relevant documentation demonstrating the steps
taken. FMC Devens has been proactive in its corrective actions and in the provision of documentation
addressing the OIG’s recommendations. The OIG acknowledges the BOP’s ongoing efforts, planned actions,
and responsiveness to our recommendations.
The BOP agreed that staffing shortages and crumbling infrastructure can create dangerous conditions in its
institutions and compromise the health and security of employees and inmates. Addressing these
challenges is among the BOP’s top priorities, and it is working closely with the Department of Justice
(Department) to obtain additional pay authorities and funding to ensure that it can fully effectuate its
mission, the BOP reported. The BOP cited the Department’s funding proposal, which contains a 5-year plan
to address the BOP’s staffing and modernization and repair challenges, submitted to Congress on
November 7, 2024. The funding proposal (referenced in our report) names as key elements a nationwide
Special Salary Rate for Correctional Officers and nurses; additional funding and positions to increase
Correctional Officer and nurse staffing; and more than $1.8 billion over 5 years to address critical
infrastructure needs, based on a 5-year Capital Investment Plan that the BOP developed with the
Department and the Office of Management and Budget. The BOP listed the FMC Devens modernization and
repair projects that are included in the Capital Investment Plan.
The BOP described agency-wide recruitment and retention progress achieved through hiring initiatives in
2024; nationwide direct hire authority for Correctional Officers approved in May 2024, resulting in 642 direct
hires in FY 2024; and a continued focus on recruiting Correctional Officers and medical positions. In
FY 2024, for example, the BOP stated that it increased new hires by approximately 14 percent and nearly
doubled its FIRST STEP Act onboard positions. Citing the October 2024 rollout of its staffing projection tool,
the BOP described its efforts to ensure that the tool accurately projects institution staffing needs, including
an August 2024 Wardens survey to collect input on position recommendations.
The BOP reported that since our inspection FMC Devens has hired new employees, including an additional
medical doctor and three new psychologists, and the institution plans to bolster programming at the Camp
with the Commercial Driver’s License program and a new dog training program. FMC Devens acknowledged
the need for employees to follow policy on conducting rounds and stated that its leadership will conduct
periodic reviews of video footage from random housing units. Finally, FMC Devens now reports no “dead
zones” or issues with the radio system, with new radios expected in FY 2025, the BOP stated.
The OIG’s analysis of the BOP’s response regarding specific recommendations and the actions necessary to
close them are discussed below. Please respond to all recommendations by March 11, 2025.
57
C.Agnello SE 0075
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 79 of 569 PageID #:
273
Recommendation 1
Ensure that FMC Devens Executive Leadership and the Central Office’s Human Resource Management
Division discuss the staffing projection tool methodology and how it compares with FMC Devens Executive
Leadership’s understanding of its current and potential future mission needs to ensure greater alignment
between stakeholder staffing projections.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and stated that FMC Devens Executive
Leadership is continuing ongoing communications with the BOP’s Human Resource Management Division
(HRMD) regarding the automated staffing tool methodology and the proper staffing levels for FMC Devens.
The BOP noted that the FMC Devens Warden completed the staffing tool survey in August 2024 and that in
September 2024 FMC Devens’s Executive Leadership, Regional Office Executive Leadership, and the
contractor discussed the staffing projection tool methodology. The BOP stated that feedback from FMC
Devens Executive Leadership included maintaining the number of authorized Correctional Services
positions (201), adding 7 additional positions to the Psychology Services Department, and decreasing the
number of Health Services positions to 123. The BOP stated that the HRMD is continuing conversations with
FMC Devens to ensure that it understands the methodology for the tool’s recommendations and that it will
continue addressing the FMC Devens feedback, as well as any additional criteria or outlier issues.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide documentation
demonstrating that FMC Devens Executive Leadership, BOP Regional Office Executive Leadership, BOP
Central Office HMRD personnel, and contractor personnel have discussed the staffing projection tool
methodology and identified any additional criteria and outlier issues for FMC Devens. Please describe any
additional progress made to achieve greater alignment between stakeholders on staffing projections.
Recommendation 2
Ensure that FMC Devens follows BOP guidance for buprenorphine and naloxone administration and
observation and that all FMC Devens employees who administer medication receive training on BOP
guidance and policies for medication administration.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and stated that, since the inspection, FMC
Devens has ensured that nurse supervisors routinely observe the process for buprenorphine and naloxone
administration and will continue to monitor the process closely. On April 26, 2024 (during our inspection), a
nursing supervisor emailed to all FMC Devens nurses relevant guidance regarding this medication
administration at the Camp facility. The BOP also noted that an FMC Devens Health Services Department
manager conducted an observational review of the Camp Medication Assisted Treatment (MAT) pill line on
May 2, 2024. According to the BOP, the review noted that not all nurses were conducting the MAT pill line
and morning pill line separately and there was not a second person available to observe during MAT
administration; the review recommended that retraining be completed for nursing employees regarding the
separation of MAT administration with the morning pill line. This review resulted in the creation of a
document on May 6, 2024, articulating issues and corrective actions. The BOP further noted that FMC
58
C.Agnello SE 0076
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 80 of 569 PageID #:
274
Devens had a Correctional Officer at the Camp observe during the MAT pill line, including conducting mouth
checks. The BOP also told us that on November 13, 2024, a nursing supervisor reinforced relevant guidance
and requirements through an email. The BOP noted that all employees who administer medication will
receive additional training during FMC Devens’s next Health Services monthly meeting in December 2024.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Since the inspection, FMC Devens
has twice reminded its nursing employees via email of the medication administration guidance and a Health
Services Department manager conducted a review of the MAT pill line that resulted in relevant corrective
actions. These corrective actions included a training session for nursing employees on conducting pill line,
nurse managers notifying the institution’s Food Service Manager of the need for food services to remain
open until nursing employees clear the last inmate from the MAT line, and nurse managers notifying the
institution’s Captain of the need for a Camp Correctional Officer to assist in observing for diversion during
the MAT pill line. Please provide: (1) training materials and documentation of training completion for all
FMC Devens employees who administer medication, as referenced with respect to the December 2024
monthly Health Services Department meeting, and (2) documentation of the nurse manager’s
communication to the Captain regarding assistance during the MAT pill line.
Recommendation 3
Implement a plan to address the medical record backlog at FMC Devens.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and stated that in early November 2024 FMC
Devens reconciled its list of pending reports and ensured that all reports received from the contracted
company had been scanned into the Bureau Electronic Medical Records System (BEMR) and removed from
the pending report list. FMC Devens continues to provide a monthly list of pending reports to the
comprehensive contract representatives and plans to engage contract representatives more frequently to
seek any time-sensitive reports. The BOP stated that FMC Devens Health Services leadership and FMC
Devens contracting specialists will continue to meet monthly and as needed to communicate expectations
related to any past due pending reports. Further, the BOP told us that contract representatives will
complete a weekly reconciliation with FMC Devens Health Services Department employees until any
pending reports are received.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide documentation
that all pending reports have been scanned into BEMR and removed from the pending report list.
Additionally, please provide the list of pending medical records and describe progress made by FMC Devens
toward reducing the backlog.
Recommendation 4
Ensure that FMC Devens develops a consistent and accurate medical record tracking procedure with the
contracted company that includes regular and recurring reconciliation of outside inmate medical records
between FMC Devens and the contracted company.
Status: Resolved.
59
C.Agnello SE 0077
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 81 of 569 PageID #:
275
BOP Response: The BOP concurred with this recommendation and provided a similar response to that for
Recommendation 3.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide the procedure that
includes regular and recurring reconciliation of outside medical records between FMC Devens and the
contracted company. Please also describe how FMC Devens will ensure the accurate tracking of its outside
medical records with the contracted company.
Recommendation 5
Ensure that FMC Devens follows the BOP Patient Care Policy for sick call and provides training to all FMC
Devens Health Services Department employees on the policy, as well as on FMC Devens sick call procedures.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and reported that FMC Devens has already
taken action to implement this recommendation. In May 2024, following our inspection, FMC Devens
provided training to its nursing employees on BOP policy and FMC Devens sick call procedures. The BOP
reported that FMC Devens directed all nursing employees to adhere to a variety of sick call guidelines,
including ensuring that the logbook is up-to-date with inmates’ information and that nurses must schedule
follow-up appointments. Since May 2024, the BOP reported that FMC Devens nurse supervisors have been
present in the outpatient clinic during sick call times to provide on-the-spot corrections to Health Services
Department employees as needed. On November 21, 2024, FMC Devens Health Services Department
management sent an email to all Health Services Department employees with specific reminders about
sick call procedures; the local procedures document was attached to the email.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide documentation
showing that nurse supervisors have been present at the outpatient clinic during sick call times since May
2024. Please also provide the training materials and documentation of training completion for all FMC
Devens Health Services Department employees, as referenced with respect to the December 2024 monthly
Health Services Department meeting. Lastly, please describe how FMC Devens will continue to ensure that
sick call procedures are followed by its employees.
Recommendation 6
Ensure that FMC Devens follows the BOP’s Clinical Practice Guidelines for Preventive Healthcare Screening
to establish a local preventive healthcare program and utilize all members of the healthcare team in
preventive healthcare.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and noted that in August 2024 FMC Devens
established a collaborative local preventive health program, which follows the current preventive health
guidance recommendations in the BOP’s Clinical Practice Guidelines (CPG) for Preventive Healthcare
Screening; the BOP provided a copy of the FMC Devens collaborative local preventive health program.
60
C.Agnello SE 0078
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 82 of 569 PageID #:
276
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide the
implementation plan for the collaborative local preventive health program.
Recommendation 7
Ensure that all FMC Devens inmates over age 50 are receiving preventive healthcare screenings, including
cognitive impairment screening.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and, as in its response to
Recommendation 6, noted that in August 2024 FMC Devens established a collaborative local preventive
health program, which follows the current BOP CPG for Preventive Healthcare Screening. Within the
collaborative local preventive health program, the BOP stated that FMC Devens is required to schedule
annual preventive health visits for inmates over age 50.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide the number of FMC
Devens inmates over age 50 who have received preventive healthcare screenings, including cognitive
impairment screenings, and supporting documentation to demonstrate that such screenings have occurred.
For inmates over age 50 who have yet to receive annual preventive healthcare screenings, including
cognitive impairment screenings, please provide documentation demonstrating when the screening is
scheduled to occur. Additionally, please provide documentation on the progress of each requirement in the
collaborative local preventive health program.
Recommendation 8
Ensure that FMC Devens verifies the credential files of all providers prior to allowing them to administer
care to inmates, and ensure that FMC Devens completes peer reviews in accordance with BOP policy.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and stated that FMC Devens verifies the
credential files of all Health Services employees at FMC Devens prior to hiring and upon license renewal.
The BOP also stated that FMC Devens is working to complete peer reviews and renew clinical privileges in
accordance with the BOP’s guidelines. The BOP reported that any credential files completed by its Health
Services Division for telepsychiatry providers will also be maintained at FMC Devens and added to the FMC
Devens credentialing tracker, in accordance with BOP policy. Two pharmacist peer reviews at FMC Devens
were submitted in September 2024 and the remaining three are scheduled to be completed and submitted
in 2025, the BOP reported. Finally, BOP Central Office issued a memorandum in February 2024 to define
and require peer reviews for all pharmacists working under a collaborative practice agreement to be
completed and submitted at the time of collaborative practice agreement renewal.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide documentation
that FMC Devens maintains the active privileges and peer reviews for telepsychiatry providers. Additionally,
please provide the results of the peer reviews of the FMC Devens pharmacists.
61
C.Agnello SE 0079
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 83 of 569 PageID #:
277
Recommendation 9
Ensure that inmates admitted to and housed in the Memory Disorder Unit are appropriately placed in
accordance with FMC Devens’s established criteria.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and reported that FMC Devens Health
Services Department management reviewed each Memory Disorder Unit (MDU) resident in May 2024 and
the Regional Medical Director reviewed them in November 2024. These reviews were intended to ensure
that inmates admitted to and housed in the MDU are appropriately placed following a diagnosis involving
dementia or chronic memory impairment. FMC Devens Health Services Department management, with
guidance from the BOP Health Services Division, is reviewing and revising the established admission criteria;
the temporary moratorium on MDU admissions will be discontinued once admission criteria are revised, the
BOP stated.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide copies of the May
and November 2024 assessments of each inmate housed in the MDU and the revised admission criteria for
the MDU once it is completed.
Recommendation 10
Ensure that FMC Devens adheres to BOP policy on medical inmate companion screening and hiring and that
FMC Devens employees screening and hiring these companions are trained on the policies and procedures.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and stated that FMC Devens Health Services
Department management reviewed the inmate companion roster in November 2024 and found that two
companions were ineligible; the ineligible inmates were subsequently terminated from their positions. The
BOP reported that the FMC Devens Health Services Department employees responsible for hiring medical
inmate companions now ensure that all medical inmate companions meet the eligibility criteria. In
September 2024, the institution provided training covering companion qualifications, eligibility, roles, and
responsibilities to both medical inmate companions and all FMC Devens employees who supervise inmate
companions, the BOP reported.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide documentation
demonstrating how FMC Devens will monitor future inmate companion eligibility, including how it will
adhere to BOP policy on medical inmate companion screening and hiring to ensure that all medical inmate
companions meet the eligibility criteria. As stated in this report, we found that multiple medical inmate
companions should have been prohibited from becoming a medical inmate companion based on the BOP’s
eligibility criteria (3 had committed a sexual offense, 8 had committed a violent offense, and 6 were Medical
Care Level 4 inmates with medical restrictions). Additionally, please provide the training plan and curriculum
for the FMC Devens Health Services Department employees responsible for hiring medical inmate
companions and the roster of trained FMC Devens employees and medical inmate companions.
62
C.Agnello SE 0080
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 84 of 569 PageID #:
278
Recommendation 11
Ensure that FMC Devens evaluates the roles and responsibilities of medical inmate companions to ensure
that they are not performing duties outside the scope of the inmate companion program.
Status: Resolved.
BOP Response: The BOP concurred with this recommendation and, as in its response to
Recommendation 10, stated that FMC Devens Health Services Department management reviewed the
inmate companion roster in November 2024 to ensure adherence to the BOP’s policy and the institution
provided training to medical inmate companions to ensure that they do not perform duties outside the
scope of the medical inmate companion program.
OIG Analysis: The BOP’s actions are responsive to the recommendation. Please provide documentation
demonstrating that all medical inmate companions have received the required training and describe how
FMC Devens will monitor and ensure that future inmate companions do not perform duties outside the
scope of the program.
63
C.Agnello SE 0081
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 85 of 569 PageID #:
279
EXHIBIT E
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0082
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 86 of 569 PageID #:
280
SUBSCRIBE
Advertisement
i
Ad
John Gotti's Daughter Victoria to
Undergo Kidney Transplant with Her
Son as Donor (Exclusive)
Victoria Gotti, the former 'Growing Up Gotti' star and mother of three, will undergo
a kidney transplant, with her son, Carmine, as her donor
By Sue Carswell | Published on November 25, 2025 04:05PM EST
57 COMMENTS
Victoria Gotti.
Credit : Jim Spellman/WireImage
S K I P TO C O N T E N T
C.Agnello SE 0083
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 87 of 569 PageID #:
281
N E E D TO K N OW
SUBSCRIBE
Victoria Gotti is to undergo a kidney transplant after learning
over the summer that she has chronic kidney disease
Her son, Carmine Agnello, will be her kidney donor
"Victoria feels her son is giving her a brand-new life," a family
source tells PEOPLE
Victoria Gotti, the daughter of infamous mob boss John Gotti, is scheduled
to have a kidney transplant in NYC at NYU Langone Health Transplant in
the upcoming weeks, PEOPLE has learned exclusively. Her eldest son,
Carmine Gotti Agnello, 39 (with ex-husband Carmine Agnello), has met
the medical qualifications to become her donor.
"She has three sons (John, 38, and Frank, 35), and all along, Carmine
insisted," said a Gotti family source. "'It's got to be me,' Carmine said.
'That's all.' Victoria feels her son is giving her a brand-new life."
S K I P TO C O N T E N T
C.Agnello SE 0084
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 88 of 569 PageID #:
282
SUBSCRIBE
Victoria Gotti at her 2019 biopic premiere in LA.
Credit: Rich Fury/Getty
Our new app is here! Free, fun and full of
exclusives. Scan to download now!
S K I P TO C O N T E N T
C.Agnello SE 0085
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 89 of 569 PageID #:
283
Gotti, 63, a best-selling novelist and former reality TV star and the
SUBSCRIBE
centerpiece of Growing Up Gotti (2004 - 2005), who later wrote and
produced the Lifetime biopic Victoria Gotti: My Father’s Daughter (2019),
has kept a low-key public profile in recent years.
Her health issues started in her 20s when she was put on blood thinners
due to a heart mitral valve prolapse (MVP) diagnosis and later a
heightened leaky valve. Her blood levels became elevated around five
years ago, says the source.
Over the summer, Gotti learned she had chronic kidney disease (CKD).
After the transplant, Gotti is expected to be recovering at home for up to
three months, while Carmine will be recovering at home for about two to
three weeks.
Victoria Gotti and son Carmine Gotti Agnello Jr. in Boca Raton in 2017.
Credit: Victoria Gotti/Instagram
S K I P TO C O N T E N T
C.Agnello SE 0086
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 90 of 569 PageID #:
R E L AT E D284S T O R I E S
SUBSCRIBE
Her Son Died at 13 Years Old After Mom Loses
Transplant Complications. How Other 13-Year-Old
Grieving Moms Are Helping Her Heal
(Exclusive) Son After
Kidney Transplants: Woman Starts Facebook Image
Matching Program
According to the United Network for Organ Sharing (UNOS), as reported
in January 2025, approximately 90,000 people are on the national kidney
transplant waiting list, with 15% of Americans facing chronic kidney
disease.
While deceased donor kidneys are most commonly used in transplants, it
can take up to three to five years to receive a match, but that timing could
be "shorter or longer," per the UNOS.
The Mayo Clinic states: "Living-donor transplantation offers an alternative
to waiting for a deceased-donor organ to become available for people in
need of an organ transplant. In addition, living-donor organ transplants
are associated with fewer complications than are deceased-donor
transplants and, overall, a longer survival of the donor organ."
S K I P TO C O N T E N T
C.Agnello SE 0087
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 91 of 569 PageID #:
285
ICTORIA GOTTI AND SONS ( GROWING UP GOTTI). A & E TELEVISION
SUBSCRIBE
NETWORK'S UPFRONT EVENT 11 Sep 2001
Victoria Gotti with sons, from left, Frank, John and Carmine Agnello in NYC (2005).
Credit: Andrea Renault/ZUMA Press Wire/Shutterstock
Never miss a story — sign up for PEOPLE's free daily newsletter to stay
up-to-date on the best of what PEOPLE has to offer, from celebrity
news to compelling human interest stories.
Gotti has always been close to her sons, attending soccer games even
when she was promoting her mystery novels and cookbooks. "Carmine
would do anything for his mother," says the family source. "But this truly
tops it."
To learn more about becoming a donor, visit the National Kidney
Registration.
L E AV E A C O M M E N T
Read more: L I F E STY L E H E A LT H C E L E B R I TY H E A LT H
S K I P TO C O N T E N T
C.Agnello SE 0088
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 92 of 569 PageID #:
286
SUBSCRIBE
You Might Like
Bethenny Frankel
Bethenny Frankel Says She Has Stage 2 Chronic Kidney Disease: 'Go Get All
Your Bloodwork Done'
Lifestyle • January 22, 2026
Teddi Mellencamp arrives at Kate Gosselin Celebrates First Time
Caesars Forum in Las Vegas, NV on Walking in Public Unassisted Since Leg
Friday November 14, 2025 Injury
Teddi Mellencamp Insists Her Cancer Kate Gosselin Celebrates First Time
Hasn't Returned After Dad John Walking Unassisted in Public Since Leg
S K I P TO C O N T E N T Injury: 'I Did It!'
C.Agnello SE 0089
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 93 of 569 PageID #:
Mellencamp Says She Was 'Really
287Lifestyle January 15, 2026 •
Sick' SUBSCRIBE
Lifestyle • 6 days ago
All comments are subject to our Community Guidelines. PEOPLE does not endorse the opinions
and views shared by readers in our comment sections.
Related Articles
C E L E B R I TY H E A LT H
Bethenny Frankel Says She Has Stage 2 Chronic
Kidney Disease: 'Go Get All Your Bloodwork Done'
By Cara Lynn Shultz 53
C E L E B R I TY H E A LT H
Teddi Mellencamp Insists Her Cancer Hasn't
Returned After Dad John Mellencamp Says She
Was 'Really Sick'
By Cara Lynn Shultz 13
C E L E B R I TY H E A LT H
Kate Gosselin Celebrates First Time Walking
Unassisted in Public Since Leg Injury: 'I Did It!'
By Cara Lynn Shultz
C E L E B R I TY H E A LT H
Dancehall Star Spice Underwent 7 Surgeries After
a Near-Death Experience: 'My Body Was
Becoming Poisonous' (Exclusive)
By Latoya Gayle
S K I P TO C O N T E N T
C.Agnello SE 0090
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 94 of 569 PageID #:
288
C E L E B R I TY H E A LT H SUBSCRIBE
Channing Tatum Shares Hospital Photos of
'Separated Shoulder' Being Screwed Back
Together After Surgery
By Kirsty Hatcher
C E L E B R I TY H E A LT H
Nicole 'Snooki' Polizzi Reveals Doctors Found
Cancerous Cells in Her Cervix: ‘I’m Scared’
By Vanessa Etienne
C E L E B R I TY H E A LT H
Guy Fieri Shares Health Update Following
Accident That Left Him in a Wheelchair: 'Worst
Thing I've Been Through in the Last 20 Years’
(Exclusive)
By Emily Rella
C E L E B R I TY H E A LT H
Ali Fedotowsky-Manno Shares 'Unsettling' Update
on Husband Kevin's Thyroid Cancer Nearly 1 Year
After Becoming 'Cancer Free'
By Charna Flam
C E L E B R I TY H E A LT H
Derek Hough Reveals the First Thing Wife Hayley
Asked Doctors After Her Emergency Craniectomy 2
Years Ago (Exclusive)
By Brianne Tracy
S K I P TO C O N T E N T
C.Agnello SE 0091
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 95 of 569 PageID #:
289
C E L E B R I TY H E A LT H SUBSCRIBE
The Traitors' Ron Funches Reveals Autism
Diagnosis After Experiencing 'Cruel Drama' from
Show: 'A Victory Worth Sharing'
By Brenton Blanchet
C E L E B R I TY H E A LT H
Savannah Guthrie Tried to Embrace Her 'Sexy
Demi Moore' Voice Before Vocal Surgery But
'Couldn't Ignore It Anymore' (Exclusive)
By Alex Ross
C E L E B R I TY H E A LT H
Katie Thurston Reveals Her Mom’s Breast Cancer
Diagnosis Nearly 1 Year After Bachelor Star Was
Diagnosed Herself
By Ingrid Vasquez
C E L E B R I TY H E A LT H
Pawn Stars' Corey Harrison Says He'll Miss Dad
Rick's Wedding After 11 Breaks in Rib Cage
By Brenton Blanchet
C E L E B R I TY H E A LT H
Octavia Spencer and Sofía Vergara Team Up for
New 'Empowering' Health Campaign: 'We're on a
Mission' (Exclusive)
By Vanessa Etienne
C E L E B R I TY H E A LT H
Jamie-Lynn Sigler Says Playing a Doctor with MS
on 'Grey's Anatomy' Meant She 'Didn't Have to
Hide' (Exclusive)
By Eileen Finan
S K I P TO C O N T E N T
C.Agnello SE 0092
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 96 of 569 PageID #:
290
C E L E B R I TY H E A LT H SUBSCRIBE
Serena Williams Is 'Healthiest' on GLP-1s, Jokes
She 'Would've Been Amazing' If She Had Them
During Pro Tennis (Exclusive)
By Vanessa Etienne
GET MORE IN OUR FREE APP
N E W S L E TT E R S
Follow Us
NEWS E N T E R TA I N M E N T
R OYA L S L I F E STY L E
STY L E WATC H SHOPPING
About Us PEOPLE Tested
Editorial Policy Careers
S K I P TO C O N T E N T
C.Agnello SE 0093
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 97 of 569 PageID #:
Privacy Policy 291Contact Us
SUBSCRIBE
Terms of Service Advertise
Your Privacy Choices
PEOPLE is part of the People Inc. publishing family.
C.Agnello SE 0094
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 98 of 569 PageID #:
292
EXHIBIT F
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0095
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 99 of 569 PageID #:
HHS Public Access 293
Author manuscript
JAMA. Author manuscript; available in PMC 2015 April 28.
Author Manuscript
Published in final edited form as:
JAMA. 2014 February 12; 311(6): 579–586. doi:10.1001/jama.2013.285141.
Risk of End-Stage Renal Disease Following Live Kidney
Donation
Abimereki D. Muzaale, MD, MPH, Allan B. Massie, PhD, Mei-Cheng Wang, PhD, Robert A.
Montgomery, MD, DPhil, Maureen A. McBride, PhD, Jennifer L. Wainright, PhD, and Dorry
L. Segev, MD, PhD
Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland
Author Manuscript
(Muzaale, Massie, Montgomery, Segev); Department of Biostatistics, Johns Hopkins Bloomberg
School of Public Health, Baltimore, Maryland (Wang, Segev); United Network for Organ Sharing,
Richmond, Virginia (McBride, Wainright); Department of Epidemiology, Johns Hopkins Bloomberg
School of Public Health, Baltimore, Maryland (Segev)
Abstract
Importance—Risk of end-stage renal disease (ESRD) in kidney donors has been compared with
risk faced by the general population, but the general population represents an unscreened, high-
risk comparator. A comparison to similarly screened healthy nondonors would more properly
estimate the sequelae of kidney donation.
Objectives—To compare the risk of ESRD in kidney donors with that of a healthy cohort of
nondonors who are at equally low risk of renal disease and free of contraindications to live
Author Manuscript
donation and to stratify these comparisons by patient demographics.
Copyright 2014 American Medical Association. All rights reserved.
Corresponding Author: Dorry L. Segev, MD, PhD, Department of Transplant Surgery, Johns Hopkins Medical Institutions, 720
Rutland Ave, Ross 771B, Baltimore, MD 21205 (dorry@jhmi.edu).
Author Contributions: Dr Muzaale had full access to all of the data in the study and takes responsibility for the integrity of the data
and the accuracy of the data analysis. Drs Muzaale and Massie contributed equally to this article.
Study concept and design: Muzaale, Massie, Segev.
Acquisition of data: Muzaale, McBride, Wainright, Segev.
Analysis and interpretation of data: Muzaale, Massie, Wang, Montgomery, Wainright, Segev.
Drafting of the manuscript: Muzaale, Massie, Segev.
Critical revision of the manuscript for important intellectual content: Muzaale, Massie, Wang, Montgomery, McBride, Wainright,
Segev.
Statistical analysis: Muzaale, Massie, Wang, McBride, Wainright, Segev.
Author Manuscript
Obtained funding: Segev.
Administrative, technical, and material support: Massie, Wainright.
Study supervision: Segev.
Supplemental content at jama.com
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of
Interest. Dr Wainright reported that she is an employee of the United Network for Organ Sharing. Dr Segev reported institutional grant
support from the National Institutes of Health. No other disclosures were reported.
Additional Contributions: United Network for Organ Sharing staff, including Dr Wainright, performed all Social Security number
linkages to Social Security Death Master File and Centers for Medicare & Medicaid Services data to ensure confidentiality of Social
Security number data provided to the OPTN. Likewise, Research Data Center staff at the National Center for Health Statistics
performed all NHANES social security number linkages to Centers for Medicare and Medicaid Services data.
Disclaimer: The analyses described herein are the responsibility of the authors alone and do not necessarily reflect the views or
policies of the US Department of Health and Human Services, nor does the mention of trade names, commercial products, or
organizations imply endorsement by the US government.
C.Agnello SE 0096
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 100 of 569 PageID #:
294
Muzaale et al. Page 2
Design, Settings, and Participants—A cohort of 96 217 kidney donors in the United States
Author Manuscript
between April 1994 and November 2011 and a cohort of 20 024 participants of the Third National
Health and Nutrition Examination Survey (NHANES III) were linked to Centers for Medicare &
Medicaid Services data to ascertain development of ESRD, which was defined as the initiation of
maintenance dialysis, placement on the waiting list, or receipt of a living or deceased donor kidney
transplant, whichever was identified first. Maximum follow-up was 15.0 years; median follow-up
was 7.6 years (interquartile range [IQR], 3.9-11.5 years) for kidney donors and 15.0 years (IQR,
13.7-15.0 years) for matched healthy nondonors.
Main Outcomes and Measures—Cumulative incidence and lifetime risk of ESRD.
Results—Among live donors, with median follow-up of 7.6 years (maximum, 15.0), ESRD
developed in 99 individuals in a mean (SD) of 8.6 (3.6) years after donation. Among matched
healthy nondonors, with median follow-up of 15.0 years (maximum, 15.0), ESRD developed in 36
nondonors in 10.7 (3.2) years, drawn from 17 ESRD events in the unmatched healthy nondonor
Author Manuscript
pool of 9364. Estimated risk of ESRD at 15 years after donation was 30.8 per 10 000 (95% CI,
24.3-38.5) in kidney donors and 3.9 per 10 000 (95% CI, 0.8-8.9) in their matched healthy
nondonor counterparts (P < .001). This difference was observed in both black and white
individuals, with an estimated risk of 74.7 per 10 000 black donors (95% CI, 47.8-105.8) vs 23.9
per 10 000 black nondonors (95% CI, 1.6-62.4; P < .001) and an estimated risk of 22.7 per 10 000
white donors (95% CI, 15.6-30.1) vs 0.0 white nondonors (P < .001). Estimated lifetime risk of
ESRD was 90 per 10 000 donors, 326 per 10 000 unscreened nondonors (general population), and
14 per 10 000 healthy nondonors.
Conclusions and Relevance—Compared with matched healthy nondonors, kidney donors
had an increased risk of ESRD over a median of 7.6 years; however, the magnitude of the absolute
risk increase was small. These findings may help inform discussions with persons considering live
Author Manuscript
kidney donation.
Every year in the United States, approximately 6000 healthy adults accept the risks of donor
nephrectomy to help family members, friends, or even strangers improve survival and
quality of life.1 It is imperative that the transplant community, in due diligence to donors,
understands the risk of donation to the fullest extent possible and communicates known risks
to those considering donation.2,3 To date, studies have shown that perioperative death is
extremely rare and subsequent survival rates are comparable with healthy nondonors.4-6
However, physiologic sequelae resulting from kidney donation remain less well
characterized. Recent single-center7-9 and nationwide10 studies suggest that live donors do
not have increased risk of end-stage renal disease (ESRD) compared with the general
population; however, the general population is unscreened and, as such, at higher inherent
Author Manuscript
risk of ESRD than carefully screened donors. Limited by small sample sizes and lack of a
healthy comparison group, previous studies have been unable to compare the risk of ESRD
that a healthy individual faces after donation with the risk that individual would have faced
had he or she not donated.11 Also, although studies show higher risk of ESRD in donor
subgroups including black donors10 compared with nonblack donors and male donors8,9
compared with female donors, these studies comparing donors with other donors cannot
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0097
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 101 of 569 PageID #:
295
Muzaale et al. Page 3
account for the fact that race and sex are associated with ESRD (and chronic kidney disease)
Author Manuscript
in nondonors as well.12-16
The goal of this study was to better understand the risk of ESRD following live donation by
comparing the incidence of ESRD in live donors with their healthy nondonor counterparts.
Methods
Live Kidney Donors
By national mandate, all kidney donations in the United States are reported to the Organ
Procurement and Transplantation Network (OPTN). Through this reporting, all adult live
donors between April 1, 1994, and November 30, 2011, were included in this study. End-
stage renal disease outcomes were ascertained by linkage to the Centers for Medicare &
Medicaid Services' (CMS's) medical evidence Form 2728 (certification of ESRD), the
Author Manuscript
transplant network's kidney waiting list transplant databases (including records through
November 30, 2011) using a combination of Social Security number, last name, first, middle
name, or all 3; date of birth; and sex. End-stage renal disease was defined as the initiation of
maintenance dialysis, placement on the waiting list, or receipt of a living or deceased donor
kidney transplant, whichever was identified first.
Matched Nondonors
The matched nondonor population was drawn from the Third National Health and Nutrition
Examination Survey (NHANES III). In this cohort, medical information was obtained from
patient self-report, physical examination, and radiologic and laboratory test results at
NHANES III enrollment between 1988 and 1994. A healthy, screened nondonor population
was derived from adult NHANES III participants by excluding those with identified
Author Manuscript
contraindications to kidney transplantation (eAppendix 1 in the Supplement). Nondonors
were individually matched with replacement to live donors using iterative expanding radius
matching.6,17-20 Matching was based on age, sex, self-identified race, educational
background, body mass index (BMI), smoking history, and systolic blood pressure
(eAppendix 2 in the Supplement). Similar to the process outlined above for live donors,
ESRD outcomes were ascertained by linkage to the CMS medical evidence Form 2728 and
to the CMS patient profile and death notification Form 2746 (including records through
September 30, 2008).
Cumulative Incidence of ESRD
Kaplan-Meier methods were used to estimate cumulative incidence of ESRD, with a time
scale of years since study entry (time of donation for donors, and enrollment into NHANES
Author Manuscript
for nondonors).21 Participants were censored at death or at the end of the study (November
30, 2011, for donors, and September 30, 2008, for nondonors).
Estimated Lifetime Risk of ESRD
Kaplan-Meier methods were used to estimate lifetime risk of ESRD, with a time scale of age
in years and left truncation of age prior to study entry. Time at risk was accrued from age at
donation for live donors and from age at enrollment into NHANES for nondonors.22 In other
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0098
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 102 of 569 PageID #:
296
Muzaale et al. Page 4
words, we estimated risk of ESRD across the life scale by splicing together observed
Author Manuscript
incidence at younger ages (accrued by individuals who were young while they were part of
the study population) with observed incidence at older ages (accrued by individuals who
were older while they were part of the study population). For example, an individual who
donated a kidney at age 45 years and was followed up for 7 years contributed to the estimate
of ESRD accrued by donors ages 45 years to 52 years. Lifetime risk was estimated for 3
populations: live donors; matched healthy nondonors; and demographically matched
unscreened nondonors (general population).
Absolute Risk Increase
The difference in cumulative incidence between the live donors (ie, those exposed to donor
nephrectomy) and the nondonor comparator populations was reported as the absolute risk
increase.
Author Manuscript
Statistical Analysis
Donor and nondonor characteristics at baseline were compared using ordinary least squares
regression for continuous variables and logistic regression for categorical variables. The P
values were estimated using bootstrap methods to account for resampling of participants in
the nondonor population necessitated by the difference in sample size between the donor and
nondonor cohorts. Risk of ESRD within live donor subgroups was compared using log-rank
tests. Risk of ESRD between live donors and healthy nondonors was compared using
bootstrap procedures tailored to the structure of our data.23 We calculated 95% confidence
intervals for ESRD incidence using separate bootstraps for the live donors and healthy
nondonors. For assessment of effect-modification by race/ ethnicity, we calculated 83.4%
confidence intervals for ESRD incidence to arrive at a type I error probability of 5%.24 Each
Author Manuscript
bootstrap repetition for the live donors and healthy nondonors drew with replacement from
the original population. However, the probability that a given record would be drawn was
proportional to the number of times it appeared in the data set, and, if drawn, all copies of
that record were added to the bootstrapped sample. Selection continued in this way until the
bootstrapped sample was the size of the original sample. All analyses were performed using
Stata 12.0/MP for Linux (Stata Corp). All hypothesis tests were 2 sided (α = .05).
Results
Study Populations
Among 96 217 live donors, 78.3% were younger than 50 years, 59.0% were women, 74.6%
were white, and 63.7% had attended college at some point; 67.6% of live donors were
Author Manuscript
biologically related to their recipient, 25.2% were obese (BMI>30, calculated as weight in
kilograms divided by height in meters squared), 9.0% had a systolic blood pressure greater
than 140 mm Hg, and 24.2% smoked cigarettes at the time of donation. Among 20 024
unscreened adult NHANES III participants, 9364 (47%) had no identified contraindication
to kidney donation and were matched 1:1 to donors to create a healthy nondonor cohort of
96 217 (Table 1).
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0099
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 103 of 569 PageID #:
297
Muzaale et al. Page 5
Frequency and Timing of ESRD
Author Manuscript
Among live donors, with median follow-up of 7.6 years (maximum, 15.0 years), ESRD
developed in 99 individuals in a mean (SD) of 8.6 (3.6) years after donation. Of donors who
subsequently developed ESRD, 50 were 18 to 39 years old at the time of donation, 57 were
men, 50 were white, and 83 were biologically related to the recipient (Table 2). By contrast,
among matched healthy nondonors, with median follow-up of 15.0 years (maximum, 15.0
years), ESRD developed in 17 individuals among the 9364 individuals in the nondonor pool,
resulting in 36 ESRD events in matched nondonors in a mean (SD) of 10.7 (3.2) years after
enrollment.
Absolute Risk Increase
Estimated cumulative incidence of ESRD at 15 years after donation was 30.8 per 10 000
(95% CI, 24.3-38.5) in donors and 3.9 per 10 000 (95% CI, 0.8-8.9) in healthy nondonors (P
Author Manuscript
< .001; Figure 1A). Absolute risk of ESRD was highest among both black donors at 74.7 per
10 000 (95% CI, 47.8-105.8) and black nondonors at 23.9 per 10 000 (95% CI, 1.6-62.4),
and the absolute risk increase was also highest in this race group (50.8 per 10 000, P < .001).
Risk among Hispanic donors was 32.6 per 10 000 (95% CI, 17.9-59.1) and for Hispanic
nondonors, it was 6.7 per 10 000 (95% CI, 0.0-15.0), for an absolute risk increase of 25.9
per 10 000 (P = .002). Absolute risk was lowest among both white donors at 22.7 per 10 000
(95% CI, 15.6-30.1) and white nondonors at 0.0 per 10 000 (95% CI, 0.0-0.0), and absolute
risk increase was also lowest in this group (22.7 per 10 000; P < .001; Figure 1B).
Cumulative Incidence by Subgroup
Although low among live donors, cumulative incidence of ESRD per 10 000 at 15 years
varied significantly by age: 29.4 (95% CI, 21.4-40.2) among those aged 18 through 39
Author Manuscript
years; 17.4 (95% CI, 10.1-30.0) among those 40 through 49 years; 54.6 (95% CI, 34.8-85.4)
among those 50 through 59 years; and 70.2 (95% CI, 30.4-161.8) among those 60 years or
older (P < .001; Figure 2A) and differed per 10 000 at 15 years by race and sex: 96.0 (95%
CI, 58.0-158.8) among black men vs 58.5 (95% CI, 34.2-100.0) among black women and
34.0 (95% CI, 22.7-51.0) among white men vs 14.6 (95% CI, 8.8-24.2) among white women
(P < .001; Figure 2B). The difference in ESRD incidence per 10 000 at 15 years between
biologically related and unrelated donors was not statistically significant: 34.1 (95% CI,
26.9-43.3) for biologically related donors vs 15.1 (95% CI, 8.7-26.3) for biologically
unrelated donors (P = .15; Figure 2C). There was no observed temporal trend in risk of
ESRD between 1994 and 2011 (trend P = .92; Figure 2D).
Estimated Lifetime Risk
Author Manuscript
Live donors had a higher estimated risk of ESRD than healthy nondonors across all ages
(Figure 3). Those who had donated at some point before the age of 30 years had an
estimated risk of 5 per 10 000 compared with healthy nondonors who had estimated risk of 0
per 10 000. Similarly, by age 50 years, estimated risk in donors was 28 per 10 000 vs 1 per
10 000 in nondonors, and by age 80 years, the estimated risk was 90 per 10 000 in donors vs
14 per 10 000 in nondonors, representing an estimated lifetime absolute risk increase of 76
per 10 000. Nevertheless, live donors had much lower estimated lifetime risk of ESRD than
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0100
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 104 of 569 PageID #:
298
Muzaale et al. Page 6
did the general population by age 80 years, 90 per 10 000 in donors vs 326 per 10 000 in the
Author Manuscript
general population.
Discussion
In this national study of 96 217 live kidney donors linked to CMS data for reliable
ascertainment of ESRD, we estimated that approximately 23 white, 33 Hispanic, and 75
black donors per 10 000 developed ESRD after kidney donation; however, ESRD occurred
in 23 white, 26 Hispanic, and 51 black individuals because they donated a kidney, whereas
the remaining cases resulted from the inherent risk of ESRD. We also determined that
kidney donors had a somewhat higher estimated risk of developing ESRD throughout their
lifetimes (90 per 10 000) than similarly healthy individuals who did not donate (14 per 10
000), but still a much lower risk than the general population (326 per 10 000).
Author Manuscript
Our findings reaffirm the prevailing belief that lifetime risk of ESRD in live donors is no
higher than in the general demographics-matched US population,7,8,10 and our estimate of
population-based risk of ESRD (derived from unscreened NHANES III participants) was
comparable with a recent estimate of 360 per 10 000 in the general US population.25
Although, to our knowledge, no association between donor nephrectomy and risk of ESRD
has been reported before, this association in our study was strong and was statistically
significant within each race/ethnicity stratum. Our findings are an extension of those by
Ibrahim et al7 who observed a decline in renal reserve in as many as 1400 per 10 000
carefully selected white donors, from a mean (SD) predonation glomerular filtration rate
(GFR) of 84 (9.2) mL/min/1.73 m2 to a post-donation GFR of less than 60 mL/min/1.73 m2
(a decline of greater than 24 mL/min/1.73 m2) in 12.2 (9.2) years after donation. Ibrahim et
al further noted development of ESRD in 30 per 10 000 of these donors 22.5 (10.4) years
Author Manuscript
after donation.
The primary strengths of our approach were the inclusion of every kidney donor in the
United States over nearly 2 decades, the highly reliable linkage-based ESRD ascertainment,
and the comparison with a healthy nondonor cohort matched on a wide range of
demographic and clinical variables. Because of the large sample size of our study
populations, we were able to estimate the incidence of a relatively rare event and to make
inferences specific to race/ethnicity subgroups, providing critical information not only for
those considering donation but also for the nearly 100 000 individuals in the United States
living after a donor nephrectomy. An additional strength of our approach was the inclusion
of an unscreened nondonor population demographically matched to the donor population. In
showing that risk of ESRD in donors was no higher (and, in fact, much lower) than in this
unscreened nondonor population, our findings are consistent with previous reports of risk of
Author Manuscript
ESRD in donors.7-10
Despite these strengths, some limitations of this study are important to note. First, our
inferences were based on 2 cohorts of healthy individuals from the United States and may
generalize imperfectly to donors in other countries.26 Second, donors are meticulously
screened, and it is possible that the donors were healthier than the healthy nondonors, even
after screening by NHANES history, physical, and laboratory testing. Third, the follow-up
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0101
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 105 of 569 PageID #:
299
Muzaale et al. Page 7
in our study, although long enough to identify a risk of ESRD in donors, was limited to 15
Author Manuscript
years and may not have permitted us to fully understand the long-term risk of donation;
however, our lifetime risk estimates enable inferences generalizable to individuals of all
ages irrespective of the number of years after donation.
It is also worth noting that the donors in this study donated between 1994-2011, whereas the
nondonors to whom they were matched entered NHANES III between 1988-1994. With
increasing incidence of ESRD over the last 2 decades,27 one might wonder if the more
recent cohort (ie, donors) had a higher risk of ESRD just by virtue of these secular trends.
However, secular trends in the general population were mediated by conditions such as
morbid obesity, diabetes, and hypertension28; these conditions have increased substantially
over the last 2 decades in the general population, but much less so in carefully screened
donors, for whom many of these conditions are contraindications to donation. As such, not
surprisingly, the ESRD rate in donors did not change over time. Furthermore, our study
Author Manuscript
screened for more than 30 medical conditions, thereby attenuating the possibility that the
increased rates of ESRD in donors were attributable to secular trends rather than to donation.
Conclusion
Compared with a matched cohort of healthy nondonors, kidney donors had an increased risk
of ESRD; however, the magnitude of the absolute risk increase was small. These findings
may help inform discussions with persons considering live kidney donation.
Supplementary Material
Refer to Web version on PubMed Central for supplementary material.
Author Manuscript
Acknowledgments
Funding/Support: This study was supported by grant R01DK096008 from the Health Resources and Services
Administration contract 234-2005-370011C.
Role of the Sponsors: The sponsors had no role in the design and conduct of the study; collection, management,
analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit
the manuscript for publication.
References
1. [Accessed April 17, 2013] Organ Procurement and Transplant Network website. http://
optn.transplant.hrsa.gov/latestData/step2.asp
2. Delmonico FL, Dew MA. Living donor kidney transplantation in a global environment. Kidney Int.
2007; 71(7):608–614. [PubMed: 17290291]
Author Manuscript
3. Poggio ED, Braun WE, Davis C. The science of stewardship: due diligence for kidney donors and
kidney function in living kidney donation— evaluation, determinants, and implications for
outcomes. Clin J Am Soc Nephrol. 2009; 4(10):1677–1684. [PubMed: 19713294]
4. Bia MJ, Ramos EL, Danovitch GM, et al. Evaluation of living renal donors: the current practice of
US transplant centers. Transplantation. 1995; 60(4):322–327. [PubMed: 7652758]
5. Matas AJ, Bartlett ST, Leichtman AB, Delmonico FL. Morbidity and mortality after living kidney
donation, 1999-2001: survey of United States transplant centers. Am J Transplant. 2003; 3(7):830–
834. [PubMed: 12814474]
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0102
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 106 of 569 PageID #:
300
Muzaale et al. Page 8
6. Segev DL, Muzaale AD, Caffo BS, et al. Perioperative mortality and long-term survival following
live kidney donation. JAMA. 2010; 303(10):959–966. [PubMed: 20215610]
Author Manuscript
7. Ibrahim HN, Foley R, Tan L, et al. Long-term consequences of kidney donation. N Engl J Med.
2009; 360(5):459–469. [PubMed: 19179315]
8. Fehrman-Ekholm I, Nordén G, Lennerling A, et al. Incidence of end-stage renal disease among live
kidney donors. Transplantation. 2006; 82(12):1646–1648. [PubMed: 17198252]
9. Wafa EW, Refaie AF, Abbas TM, et al. End-stage renal disease among living-kidney donors: single-
center experience. Exp Clin Transplant. 2011; 9(1):14–19. [PubMed: 21605018]
10. Cherikh WS, Young CJ, Kramer BF, Taranto SE, Randall HB, Fan PY. Ethnic and gender related
differences in the risk of end-stage renal disease after living kidney donation. Am J Transplant.
2011; 11(8):1650–1655. [PubMed: 21672160]
11. Garg AX, Muirhead N, Knoll G, et al. Donor Nephrectomy Outcomes Research (DONOR)
Network. Proteinuria and reduced kidney function in living kidney donors: a systematic review,
meta-analysis, and meta-regression. Kidney Int. 2006; 70(10):1801–1810. [PubMed: 17003822]
12. Eriksen BO, Ingebretsen OC. The progression of chronic kidney disease: a 10-year population-
based study of the effects of gender and age. Kidney Int. 2006; 69(2):375–382. [PubMed:
Author Manuscript
16408129]
13. Hsu CY, Iribarren C, McCulloch CE, Darbinian J, Go AS. Risk factors for end-stage renal disease:
25-year follow-up. Arch Intern Med. 2009; 169(4):342–350. [PubMed: 19237717]
14. Brancati FL, Whittle JC, Whelton PK, Seidler AJ, Klag MJ. The excess incidence of diabetic end-
stage renal disease among blacks: a population-based study of potential explanatory factors.
JAMA. 1992; 268(21):3079–3084. [PubMed: 1433738]
15. Klag MJ, Whelton PK, Randall BL, Neaton JD, Brancati FL, Stamler J. End-stage renal disease in
African-American and white men: 16-year MRFIT findings. JAMA. 1997; 277(16):1293–1298.
[PubMed: 9109467]
16. Lentine KL, Schnitzler MA, Xiao H, et al. Racial variation in medical outcomes among living
kidney donors. N Engl J Med. 2010; 363(8):724–732. [PubMed: 20818874]
17. Montgomery RA, Lonze BE, King KE, et al. Desensitization in HLA-incompatible kidney
recipients and survival. N Engl J Med. 2011; 365(4):318–326. [PubMed: 21793744]
18. Berger JC, Muzaale AD, James N, et al. Living kidney donors ages 70 and older: recipient and
Author Manuscript
donor outcomes. Clin J Am Soc Nephrol. 2011; 6(12):2887–2893. [PubMed: 22034505]
19. Muzaale AD, Dagher NN, Montgomery RA, Taranto SE, McBride MA, Segev DL. Estimates of
early death, acute liver failure, and long-term mortality among live liver donors. Gastroenterology.
2012; 142(2):273–280. [PubMed: 22108193]
20. Van Arendonk KJ, Orandi BJ, James NT, Segev DL, Colombani PM. Living unrelated renal
transplantation: a good match for the pediatric candidate? J Pediatr Surg. 2013; 48(6):1277–1282.
[PubMed: 23845618]
21. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc.
1958; 53(282):25.
22. Vasan RS, Beiser A, Seshadri S, et al. Residual lifetime risk for developing hypertension in
middle-aged women and men: the Framingham Heart Study. JAMA. 2002; 287(8):1003–1010.
[PubMed: 11866648]
23. Efron B. Bootstrap methods: another look at the jackknife. Ann Stat. 1979; 7(1):1–27.
24. Knol MJ, Pestman WR, Grobbee DE. The (mis)use of overlap of confidence intervals to assess
effect modification. Eur J Epidemiol. 2011; 26(4):253–254. [PubMed: 21424218]
Author Manuscript
25. Grams ME, Chow EK, Segev DL, Coresh J. Lifetime incidence of CKD stages 3-5 in the United
States. Am J Kidney Dis. 2013; 62(2):245–252. [PubMed: 23566637]
26. Horvat LD, Shariff SZ. Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network.
Global trends in the rates of living kidney donation. Kidney Int. 2009; 75(10):1088–1098.
[PubMed: 19225540]
27. US Renal Data Systems. USRDS 2006 Annual Data Report: Atlas of End-Stage Renal Disease in
the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases; 2007.
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0103
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 107 of 569 PageID #:
301
Muzaale et al. Page 9
28. Coresh J, Selvin E, Stevens LA, et al. Prevalence of chronic kidney disease in the United States.
JAMA. 2007; 298(17):2038–2047. [PubMed: 17986697]
Author Manuscript
Author Manuscript
Author Manuscript
Author Manuscript
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0104
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 108 of 569 PageID #:
302
Muzaale et al. Page 10
Author Manuscript
Author Manuscript
Author Manuscript
Figure 1. Cumulative Incidence of End-Stage Renal Disease in Live Kidney Donors and Matched
Healthy Nondonors
A, The shaded areas indicate 95% confidence intervals obtained by bootstrapping. Matched
healthy nondonors were identified among participants in the third National Health and
Nutrition Examination Survey and were drawn with replacement in light of a larger
population of donors compared with healthy nondonors by bootstrapping (see the Methods
section).
Author Manuscript
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0105
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 109 of 569 PageID #:
303
Muzaale et al. Page 11
Author Manuscript
Author Manuscript
Author Manuscript
Figure 2. Cumulative Incidence of End-Stage Renal Disease in Live Kidney Donors
Estimates obtained using Kaplan-Meier methods and compared using log-rank tests. The y-
axis scale shown in blue indicates the range from 0 to 40 events per 10 000.
Author Manuscript
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0106
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 110 of 569 PageID #:
304
Muzaale et al. Page 12
Author Manuscript
Author Manuscript
Figure 3. Estimated Lifetime Risk of End-Stage Renal Disease in Matched But Unscreened
Nondonors, Live Kidney Donors, and Matched Healthy Nondonors
Nondonors were identified among participants in the third National Health and Nutrition
Examination Survey. Healthy nondonors were a subset of unscreened nondonors.
Comparisons were made by bootstrapping.
Author Manuscript
Author Manuscript
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0107
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 111 of 569 PageID #:
305
Muzaale et al. Page 13
Table 1
Characteristics of Live Kidney Donors in the United States at the Time of Donation and
Matched Healthy Nondonors in the United States at the Time of NHANES Enrollment
Author Manuscript
Characteristicsa Live Kidney Donors, % (n = 96 217) Matched Healthy Nondonors, % (n
P Value
= 96 217)b
Age, mean (SD), y 40.2 (11.1) 40.2 (11.1) .90
18-39 48.2 48.0
40-49 30.1 29.8
.70
50-59 17.5 17.9
≥60 4.2 4.3
Women 59.0 59.0 >.99
Race/ethnicityc
White/other 74.6 74.6
Author Manuscript
Black 12.9 12.9 >.99
Hispanic 12.5 12.5
Educational statusd
≤High school 36.3 42.5
Attended college 28.4 25.8
<.001
College graduate 25.1 21.0
Post college 10.2 10.7
BMIe
Mean (SD) 26.7 (7.5) 26.2 (4.8) <.001
<24 33.0 40.1
25-29 41.8 38.6 <.001
Author Manuscript
≥30 25.2 21.3
Blood pressure, mm Hgf
Systolic
Mean (SD) 121.0 (16.3) 119.2 (12.5) <.001
<120 44.3 51.1
120-139 46.7 43.0 <.001
≥140 9.0 5.9
Diastolic
Mean (SD) 73.6 (11.5) 75.5 (10.2) <.001
<80 69.0 62.1
80-89 26.6 30.3 <.001
Author Manuscript
≥90 4.4 7.6
Smokerg 24.2 10.4 <.001
Creatinine, mean (SD), mg/dL 0.9 (0.2) 1.0 (0.2) <.001
eGFR, mL/min/1.73 m2,h
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0108
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 112 of 569 PageID #:
306
Muzaale et al. Page 14
Characteristicsa Live Kidney Donors, % (n = 96 217) Matched Healthy Nondonors, % (n
P Value
= 96 217)b
Author Manuscript
Mean (SD) 100.7 (23.7) 86.4 (24.6) <.001
<80 22.1 41.1
80-89 7.2 10.2 <.001
≥90 70.7 48.7
Urine albumin:creatinine ratio, mean (SD), μg/mg 0.04 (0.6)
Biologically related to recipienti 67.6
Year of donation
1994-1997 13.8
1998-2001 21.5
2002-2005 26.9
2006-2009 25.8
Author Manuscript
2010-2011 12.0
Abbreviations: Blank cells, not applicable; BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; eGFR,
estimated glomerular filtration rate; NHANES, National Health and Nutrition Examination Survey.
SI conversion: To convert creatinine from mg/dL to μmol/L, multiply by 88.4.
a
Characteristics at the time of donation (April 1994-November 2011) and at enrollment (January 1988-December 1994) are shown; age, sex, and
race/ethnicity were available throughout the study period.
b
Matched healthy nondonors were identified among participants in the NHANES III survey and were drawn with replacement in light of a larger
population of donors than of healthy nondonors. Participants with missing data were excluded from this study.
c
For race/ethnicity, the category of “Other” included American Indian, Native Hawaiian, Alaskan Native, Pacific Islander, and multiracial.
d
For donors, education was only available after 1998 (42% missing between 2000-2004; 21% missing between 2005-2009, 9% missing
2010-2011).
e
Author Manuscript
Body mass index was only available after 2003 (33% missing between 2005-2009; 19% missing between 2010-2011).
f
Blood pressure was only available after 1999 (24% missing between 2000-2004; 8% missing between 2005-2009; 4% missing between
2010-2011).
g
Smoking status was only available after 2004 (5% missing between 2005-2009; 1% missing between 2010-2011).
h
Creatinine and eGFR (estimated using the chronic kidney disease– epidemiology collaboration equation) were only available after 1997 (34%
missing between 1998-2001; 5% missing between 2002-2005; 1% missing after 2006).
i
The Relationship to recipient was missing for 0.25% records between 1994-2011.
Author Manuscript
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0109
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 113 of 569 PageID #:
307
Muzaale et al. Page 15
Table 2
Development of End-Stage Renal Disease in Subgroups of Live Kidney Donors in the
United States, 1994-2011
Author Manuscript
No. of Donors Cases of ESRD Cumulative Incidence of ESRD at 15 Years per 10 000 (95% CI)
All donorsa 96 217 99 30.8 (24.3-38.5)
Age at donation, y
18-39 46 344 50 29.4 (21.4-40.2)
40-49 28 994 17 17.4 (10.1-30.0)
50-59 16 840 25 54.6 (34.8-85.4)
≥60 4039 7 70.2 (30.4-161.8)
Sex
Women 56 775 42 21.1 (14.9-29.9)
Men 39 442 57 44.1 (32.9-59.1)
Author Manuscript
Race
White/other 71 769 50 22.7 (15.6-30.1)
Black 12 387 36 74.7 (47.8-105.8)
Hispanic 12 061 13 32.6 (17.9-59.1)
Relationship to recipientb
Biological 64 897 83 34.1 (26.9-43.3)
Nonbiological 31 081 16 15.1 (08.7-26.3)
a
In a mean (SD) of 8.6 (3.6) years after donation, 99 donors who were aged 50 (13) years developed end-stage renal disease (ESRD).
b
Relationship to recipient was missing for 0.25% of the records between 1994-2011.
Author Manuscript
Author Manuscript
JAMA. Author manuscript; available in PMC 2015 April 28.
C.Agnello SE 0110
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 114 of 569 PageID #:
308
EXHIBIT G
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0111
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 115 of 569 PageID #:
309
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
Home | JAMA | Vol. 303, No. 10
Original Contribution
Perioperative Mortality and Long-term Survival Following
Live Kidney Donation
Dorry L. Segev, MD, PhD; Abimereki D. Muzaale, MD, MPH; Brian S. Caffo, PhD ; et al
Author Affiliations | Article Information
Cite Permissions Metrics
JAMA
Published Online: March 10, 2010
2010;303;(10):959-966.
doi:10.1001/jama.2010.237
Abstract
Context More than 6000 healthy US individuals every year undergo nephrectomy for the purposes of live
donation; however, safety remains in question because longitudinal outcome studies have occurred at sin-
gle centers with limited generalizability.
Objectives To study national trends in live kidney donor selection and outcome, to estimate short-term
operative risk in various strata of live donors, and to compare long-term death rates with a matched cohort
of nondonors who are as similar to the donor cohort as possible and as free as possible from contraindica-
tions to live donation.
C.Agnello SE 0112
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 116 of 569 PageID #:
310
Design, Setting, and Participants Live donors were drawn from a mandated national registry of 80 347 live
donors in the United
States between
RELATED ARTICLES
kidney FIGURES SUPPLEMENTAL CONTENT
April 1, 1994, and March 31, 2009. Median (interquartile
range) follow-up was 6.3 (3.2-9.8) years. A matched cohort was drawn from 9364 participants of the third
National Health and Nutrition Examination Survey (NHANES III) after excluding those with contraindica-
tions to kidney donation.
Main Outcome Measures Surgical mortality and long-term survival.
Results There were 25 deaths within 90 days of live kidney donation during the study period. Surgical
mortality from live kidney donation was 3.1 per 10 000 donors (95% confidence interval [CI], 2.0-4.6) and
did not change during the last 15 years despite differences in practice and selection. Surgical mortality was
higher in men than in women (5.1 vs 1.7 per 10 000 donors; risk ratio [RR], 3.0; 95% CI, 1.3-6.9; P = .007),
in black vs white and Hispanic individuals (7.6 vs 2.6 and 2.0 per 10 000 donors; RR, 3.1; 95% CI, 1.3-7.1;
P = .01), and in donors with hypertension vs without hypertension (36.7 vs 1.3 per 10 000 donors; RR,
27.4; 95% CI, 5.0-149.5; P < .001). However, long-term risk of death was no higher for live donors than for
age- and comorbidity-matched NHANES III participants for all patients and also stratified by age, sex, and
race.
Conclusion Among a cohort of live kidney donors compared with a healthy matched cohort, the mortality
rate was not significantly increased after a median of 6.3 years.
With a significant organ shortage in the United States and with minimal expansions of the deceased donor
pool in recent decades, many patients with end-stage renal disease are turning to live donor kidney trans-
plantation to improve survival and quality of life.1-5 Although many healthy adults are eager and willing to
accept the risk of donor nephrectomy to help their loved ones, the responsibility lies within the medical
community to quantify these risks as best as possible and to make this information available to those con-
sidering donation.
Evidence to date suggests that live kidney donation is safe.3,6-14 In fact, some studies show that live
donors have better outcomes than their population counterparts.1,3 But inferences have thus far been lim-
ited by lack of generalizability, restrictive sample size, and inappropriate comparison groups. Most studies
that have evaluated live donor outcomes have been conducted at single academic centers with carefully
selected, primarily white individuals who receive close follow-up and are often involved in funded research
studies. Furthermore, although some single centers have studied as many as 3700 donors,3 the event rate
for long-term death in live donors is so low that the power to detect differences in outcomes is limited
with these sample sizes. Finally, comparison groups for long-term outcomes have been limited to pub-
lished population-based life tables or heavily confounded reference populations and as such lack the abil-
ity to select healthy controls in a manner comparable with the screening process for kidney donors.
C.Agnello SE 0113
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 117 of 569 PageID #:
311
The goal of our study was to extend previous studies of live donor outcomes to a large generalizable co-
of all live kidney donors
hort
RELATED ARTICLES in the
FIGURES SUPPLEMENTAL CONTENT
United States during a 15-year period, to study national trends in live
kidney donor selection and outcome, to estimate short-term operative risk in various strata of live donors,
and to improve the long-term comparison group by identifying a matched cohort of nondonors who are as
similar to the donor cohort as possible and as free as possible from contraindications to live donation.
Methods
Study Population
Live Donors. By national mandate, all live kidney donors are reported to the Organ Procurement and
Transplantation Network through the United Network for Organ Sharing (UNOS). A total of 80 347 live
kidney donors between April 1, 1994, and March 31, 2009, were included in this study, excluding only 24
donors where age was not recorded and 12 donors where age was recorded as younger than 18 years. All
donor characteristics are reported by the transplant centers to UNOS and are shown as entered on the
donor registration form. Postdonation death was ascertained by linking donors to the Social Security Death
Master File as of March 31, 2009, using the social security number and confirming with 1 or more of the
following identifiers: first name, last name, middle initial, and date of birth, as has been previously re-
ported in other studies of live donors.3
Matched Cohort. Potential comparison patients were identified from among participants of the third
National Health and Nutrition Examination Survey (NHANES III) conducted between 1988 and 1994.
NHANES III was a national household survey conducted by the National Center for Health Statistics of the
Centers for Disease Control and Prevention using a complex oversampled multistage sample design.
Baseline comorbidities and other medical information was obtained through home interviews, physical ex-
aminations, and radiographic and laboratory test results. Death among NHANES III participants was simi-
larly ascertained by linkage as described above for the live donors, allowing for a reasonable comparison of
death rates. Of 20 024 adults in the NHANES III, 9458 with recorded comorbidities or other factors that
would have deemed them ineligible at most transplant centers were excluded. Exclusion comorbidities in-
cluded kidney disease, diabetes, heart disease, and hypertension. Although some transplant programs ac-
cept donors with hypertension, the degree of hypertension is not recorded in either data set, and it is likely
that donors with hypertension are well-controlled; therefore, for the sake of a reference group, donors
with hypertension were held to the comparison standard of controls without hypertension.
Additional exclusion factors included answering “yes” to any of the questions listed in the eTable. Finally,
NHANES III participants who were missing information on kidney disease, diabetes, heart disease, or hyper-
tension could not serve as part of a comparison cohort and were thus excluded (n = 1228). A total of 9364
NHANES III participants remained who were without contraindications to live donation; 1 matched control
for each live kidney donor was selected from this remaining NHANES III population with replacement, as
fully delineated in the eMethods.
C.Agnello SE 0114
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 118 of 569 PageID #:
312
Statistical Analysis
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
Mortality estimates were obtained by Kaplan-Meier curve methods, with administrative censoring at the
time of linkage to the Social Security Death Master File. For live donors, time at risk was accrued from the
date of donation. For NHANES III controls, time at risk was accrued from the date of enrollment into the
study. Early postsurgical (3-month and 12-month) death rates were calculated per 10 000 donors with
95% confidence intervals (CIs) derived using Poisson exact intervals. Differences in early postsurgical
deaths across donor characteristics were analyzed by using χ2 tests of independence. Associations be-
tween donor characteristics and long-term death (all deaths including early deaths) were analyzed using
nested Cox proportional hazards regression models. Long-term death rates between live kidney donors
and the matched cohort were compared using log-rank tests. Based on the number of patients for whom
we had 10-year follow-up and a 10-year survival of 97%, we had 80% power to detect a difference of 1%;
in other words, if live donor survival at 10 years was 96% or lower and matched cohort survival was 97%,
we would anticipate having the power to detect this difference. All analyses were performed by using mul-
tiprocessor Stata version 11.0/MP for Linux (StataCorp, College Station, Texas), with α = .05. When applica-
ble, all hypothesis tests were 2-sided.
Results
Donor Demographics
There was a significant increase in live donor kidney transplants in the United States during the last 15
years (from 3009 in 1994 to 5968 in 2008). Donor age changed considerably over time, with 13.9% of
donors older than 50 years in 1994 compared with 22.8% in 2008. A total of 58 683 live kidney donors
(73.1%) were white, 10 505 (13.1%) were black, and 9846 (12.3%) were Hispanic (Table 1). Educational
backgrounds varied, with 38.4% of live kidney donors educated at grade school or high school level,
28.0% with some college, and 33.6% with a bachelor's degree or postcollege. Of donors where body mass
index (BMI, calculated as weight in kilograms divided by height in meters squared) information was avail-
able (after 2003), 22.6% were obese (BMI ≥30). Very few individuals (1.8%) were categorized as having
hypertension in the same era.
Table 1. Demographic and Predonation Characteristics of Live Kidney Donorsa
View Large Download
Table 1. Demographic and Predonation Characteristics of Live Kidney Donorsa
C.Agnello SE 0115
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 119 of 569 PageID #:
313
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
C.Agnello SE 0116
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 120 of 569 PageID #:
314
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
C.Agnello SE 0117
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 121 of 569 PageID #:
315
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
Early Postsurgical Death
In general, the risk of death in the first 90 days following live donor nephrectomy was 3.1 per 10 000
donors in the first 90 days (95% CI, 2.0-4.6) (Table 2). Although more conservative than the commonly
used 30-day perioperative mortality metric, death in the first 90 days seemed a good measure of surgical
mortality, because this rate greatly exceeded the risk of death in the first 90 days for the NHANES III
matched cohort (0.4 per 10 000 donors; 95% CI, 0.1-1.1; P < .001) compared with live donors. By 1 year
following nephrectomy, risk of death in the matched cohort was similar (4.6 per 10 000 donors; 95% CI,
C.Agnello SE 0118
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 122 of 569 PageID #:
316
3.2-6.3; vs 6.5 per 10 000 donors; 95% CI, 4.8-8.5; P = .11) to the live donor cohort, likely representing
attributable to
RELATED ARTICLES
deaths than surgical mortality.
FIGURES
comorbidity rather
SUPPLEMENTAL CONTENT
Table 2. Death Within 3 and 12 Months of Live Donor Nephrectomya
View Large Download
Table 2. Death Within 3 and 12 Months of Live Donor Nephrectomya
Surgical mortality did not change during the 15-year period, despite differences in surgical practice and
donor selection (Table 2). Men had a statistically significantly higher surgical mortality than women did (5.1
per 10 000 donors; 95% CI, 3.0-8.2; vs 1.7 per 10 000 donors; 95% CI, 0.7-3.4; risk ratio [RR], 3.0; 95%
CI, 1.3-6.9, P = .007), as did black individuals vs white and Hispanic individuals (7.6 per 10 000 donors;
95% CI, 3.3-15.0; vs 2.6 per 10 000 donors; 95% CI, 1.4-4.2; and 2.0 per 10 000 donors; 95% CI, 0.2-7.3;
RR, 3.1; 95% CI, 1.3-7.1; P = .01 vs nonblack individuals). Donors with hypertension also had a statistically
significantly higher surgical mortality than did donors without hypertension (36.7 per 10 000 donors; 95%
CI, 4.4-132.6; vs 1.3 per 10 000 donors; 95% CI, 0.4-3.4; RR, 27.4; 95% CI, 5.0-149.5; P < .001), although
this was based on only 2 deaths among 545 donors with hypertension; therefore, as indicated by the wide
C.Agnello SE 0119
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 123 of 569 PageID #:
317
CI, the magnitude of the excess surgical risk remains quite uncertain. No statistically significant difference
surgical mortality was
in
RELATED ARTICLES observed by
age, smoking status, BMI, or systolic blood pressure (SBP).
FIGURES SUPPLEMENTAL CONTENT
Long-term Donor Survival
Similar associations were observed when studying long-term mortality after live kidney donation as were
shown in postsurgical death rates. When analyzing the entire cohort of live donors, individuals aged 50 to
59 years (hazard ratio [HR], 3.3; 95% CI, 2.6-4.1; unadjusted 3.5% 12-year mortality for this subgroup vs
1.3% 12-year mortality for those adults younger than 40 years), aged 60 years or older (HR, 9.4; 95% CI,
7.3-12.1; unadjusted 9.4% 12-year mortality for this subgroup), male sex (HR, 1.7; 95% CI, 1.5-2.0; unad-
justed 2.7% 12-year mortality for men vs 1.9% 12-year mortality for women), and black race (HR, 1.3; 95%
CI, 1.0-1.6; unadjusted 2.8% 12-year mortality for black individuals vs 1.7% 12-year mortality for white indi-
viduals) were associated with higher rates of long-term death (model 1 in Table 3). These associations were
also observed in the cohort of donors between 2000 and 2009, where information about SBP was also
available (model 2 in Table 3). In this cohort, SBP of 140 mm Hg or higher was also associated with a higher
rate of death (HR, 1.7; 95% CI, 1.1-2.9; unadjusted 4.0% 9-year mortality vs 1.4% 9-year mortality for SBP
of <120 mm Hg) (model 2 in Table 3).
Table 3. Characteristics Associated with Survival Among Live Donorsa
View Large Download
Table 3. Characteristics Associated with Survival Among Live Donorsa
Table 3. Characteristics Associated with Survival Among Live Donorsa
Missing covariate data resulted in a cohort limited to donors between 2004 and 2009 when studying the
effect of smoking and hypertension (model 3 in Table 3). This cohort was one-fourth the size of the full co-
hort, with about one-third of the follow-up time (median [interquartile range], 2.1 [1.0-3.1] years; vs 6.3
[3.2-9.8] years for the full cohort), and many of the associations observed in the larger cohorts with longer
follow-up were not detected in this model. In fact, the only statistically significant associations were SBP
of 140 mm Hg or higher (HR, 3.3; 95% CI, 1.1-9.7; unadjusted 4% 9-year mortality vs 1% 9-year mortality
for SBP of <120 mm Hg) and smoking (HR, 5.3; 95% CI, 2.6-10.8; unadjusted 1.0% 4-year mortality vs
0.7% 4-year mortality for nonsmokers), while hypertension was not associated with increased risk of death
(HR, 0.9; 95% CI, 0.1-6.6; unadjusted 0.7% 3-year mortality vs 0.5% 3-year mortality for those donors
without hypertension).
Matched NHANES III Cohort
C.Agnello SE 0120
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 124 of 569 PageID #:
318
Although 90-day death rates were higher for live kidney donors (Table 2), long-term mortality was similar
lower for live kidney
or
RELATED ARTICLES
donors than
FIGURES SUPPLEMENTAL CONTENT
for the matched NHANES III cohort throughout the 12-year period of
follow-up (5-year follow-up: 0.4% vs 0.9% and 12-year follow-up: 1.5% vs 2.9%; P < .001 by log-rank
test) (Figure 1). Similar patterns were observed when comparing live kidney donors with matched controls
stratified by age (Figure 2), sex (Figure 3), and race (Figure 3) (P < .001 for all comparisons by log-rank
test).
View Large Download
Figure 1. Kaplan-Meier Curves Comparing Cumulative Mortality of Live Kidney Donors and Matched
Controls for the Entire Cohort of Live Donors
Figure 1. Kaplan-Meier Curves Comparing Cumulative Mortality of Live Kidney Donors and Matched
Controls for the Entire Cohort of Live Donors
Matched controls were identified among participants in the third National Health and Nutrition Examination
Survey.
View Large Download
Figure 2. Kaplan-Meier Curves Comparing Cumulative Mortality of Live Kidney Donors and Matched
Controls by Age Category
Figure 2. Kaplan-Meier Curves Comparing Cumulative Mortality of Live Kidney Donors and Matched
Controls by Age Category
Matched controls were identified among participants in the third National Health and Nutrition Examination
Survey.
View Large Download
Figure 3. Kaplan-Meier Curves Comparing Cumulative Mortality of Live Kidney Donors and Matched
Controls by Sex and Race
Figure 3. Kaplan-Meier Curves Comparing Cumulative Mortality of Live Kidney Donors and Matched
Controls by Sex and Race
Matched controls were identified among participants in the third National Health and Nutrition Examination
Survey.
C.Agnello SE 0121
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 125 of 569 PageID #:
319
Comment
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
The benefits of live donation for the recipient in terms of reduction in waitlist mortality and longevity after
transplantation have been well demonstrated. It is incumbent on the transplantation community to show
that these lives are not saved at the cost of placing the donors at risk for excess perioperative or long-term
mortality. In our study of all live donors during a 15-year period in the United States, 25 of 80 347 donors
died within 3 months of donation, for an estimated surgical mortality of 3.1 per 10 000 cases. This com-
pares with reported surgical mortality of approximately 18 per 10 000 cases for laparoscopic
cholecystectomy15 and approximately 260 per 10 000 cases for nondonor nephrectomy.16 Although the
proportion of donors older than 50 years nearly doubled, the death rate did not change over time.
Similarly, although more than 20% of live donors were obese (BMI ≥30), surgical mortality was not associ-
ated with obesity. Although it is possible that surgical mortality was higher for older adults, this difference
was also not statistically detectable. Surgical mortality was demonstrably higher for men (RR, 3.0), black
individuals (RR, 3.1), and those reported to have hypertension (RR, 27.4), consistent with higher rates of
death after other surgical procedures for these subgroups.17-21 These factors were also associated with
higher risk of long-term death, consistent with known population factors associated with vulnerability to
mortality. Most importantly, long-term death rates were no higher for live donors than for the matched co-
hort of NHANES III participants selected to most closely resemble live donors.
The strength of our study lies in its generalizability, sample size, and choice of comparison group. This is
the first longitudinal survival study to our knowledge that draws from the entire population of live US
donors during a 15-year period. The use of a complete national population is critical, as most single-center
studies to date have involved white donors without hypertension from large-volume transplant centers.
For example, the largest longitudinal study of donors to date (3700 live donors at the University of
Minnesota), although important and informative, is limited to a population that is nearly 100% white.3
However, we have shown that 26% of US donors are nonwhite and outcomes differ by race/ethnicity, with
higher surgical and long-term mortality in black individuals. With more than 10 000 black individuals in
our study, we were also able to compare survival of these donors with their NHANES III controls; this com-
parison has not been possible in previous studies.
The large sample size of more than 80 000 live donors allows for more robust inferences about surgical
mortality, which is a rare event (3.1 per 10 000 cases overall), and for comparison of death rates by various
strata, including age, sex, race/ethnicity, BMI, SBP, and smoking. This is particularly relevant in terms of
donor counseling, because risk awareness is the essence of informed consent when a healthy person em-
barks on a major operation. Previous surgical mortality estimates have been based mostly on self-report
and literature review, with the risk of reporting bias, recall bias, and publication bias. Estimates currently
quoted to candidate donors range from 0.03% based on a self-reported survey of members of a profes-
sional society conducted in 19928 to 0.06% based on a study of 8200 live donors drawn from the litera-
ture and a self-reported survey conducted in 1987.22 Surgical mortality in the recent era has not been esti-
C.Agnello SE 0122
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 126 of 569 PageID #:
320
mated in general or for any stratified populations. The 15-year period included in our study is inclusive of
transition from the
the
RELATED ARTICLES of the open nephrectomy to the laparoscopic nephrectomy.23,24
FIGURES
predominance
SUPPLEMENTAL CONTENT
Although not statistically significant, it is entirely possible that the increase in surgical mortality between
1994-1997 and 1998-2005, and the subsequent reduction thereafter, reflects the learning curve with new
technology.12 If this is true, a mortality between 1.5 per 10 000 donors (from 1994-1997) and 2.0 per
10 000 donors (from 2006-2009) may be more representative as live donor nephrectomy moves forward.
Long-term live donor survival has traditionally been compared with population-based survival estimates.
For example, Fehrman-Ekholm et al6 compared live donor survival to expected survival using national
mortality rates. Recently, Ibrahim et al3 compared live donor survival with general population life tables
from the National Center for Health Statistics. However, clearly live donors are very carefully selected and
an appropriate comparison group should be selected in a similar manner. In applying our exclusion criteria,
which were based on standard live donor candidate workup4 as best ascertained by NHANES III data, more
than half of the NHANES III cohort were found to be ineligible for live donation, illustrating the bias that is
inherent in population-based comparison groups. Our matched cohort was thus carefully constructed to
represent (within the limitations of the data) potential candidates for live donation and oversampled to
represent the demographic distribution of the live donor cohort. Despite these efforts, unmeasured con-
founding still likely explains the lower observed survival among the matched cohort, given that candidate
live donors are very carefully screened by multidisciplinary teams and significant laboratory and radio-
graphic testing, while we were only able to exclude a proportion of the NHANES III controls based on ap-
proximately 30 screening questions.
Our study is limited by availability of data, duration of follow-up, and statistical artifacts resulting from an
oversampled matched cohort. Of the 80 347 donors registered by national mandate through UNOS, all had
information about age, sex, race/ethnicity, and vital status throughout the study period. However, more
granular information about education, BMI, SBP, hypertension, and smoking was only available in the later
periods. As a result, our ability to estimate early surgical mortality stratified by these factors was limited to
a smaller (yet still very large and nationally representative) subset of donors (n = 22 745-47 695).
Furthermore, our ability to make inferences about the effects of SBP, hypertension, or smoking on long-
term survival was limited by shorter follow-up (maximum follow-up, 4.3-9.3 years vs 15.1 years for those
donors with only age, sex, and race/ethnicity information).
Although NHANES III is a large, representative, and commonly studied population of potential comparison
patients, this cohort was one-eighth the size of the live donor cohort after appropriate exclusions. As a re-
sult, in generating a matched cohort based on these patients, we had to sample with replacement (some
patients were used more than once in the matched cohort). Although this accounted for confounding by
making the matched cohort similar in demographics to the live donor cohort, the oversampling caused an
artificially larger sample size for the purposes of standard error estimates. Of all statistical analyses per-
formed in our study, the only one affected was the statistical comparison of the live donor survival with the
C.Agnello SE 0123
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 127 of 569 PageID #:
321
matched cohort survival, where we found that live donors had a statistically significantly better survival
their NHANES III counterparts.
than
RELATED ARTICLES
FIGURES SUPPLEMENTAL CONTENT
Although it is unlikely that this substantial difference was driven by
the artificial increase in sample size, we can still safely conclude that live donors did not have statistically
significantly worse survival than their NHANES III counterparts.
We have shown that live kidney donation is safe and free from significant long-term excess mortality.
Although perioperative mortality is low (3.1 of 10 000 cases), some subgroups seem to be at higher risk
and individuals from these demographic groups should be counseled accordingly. Importantly, although
selection criteria have changed over time and more adults older than 50 years are donating, we found no
evidence that these adults are at higher risk of surgical mortality and no evidence that surgical mortality is
changing over time. This suggests that current screening practices, even in older age groups, still result in
a well-selected group of healthy adults.
Regardless of what physiologic changes might occur in a healthy adult after kidney donation, our findings
of similar long-term survival between donors and healthy comparison patients suggest that these physio-
logic changes do not result in premature death. Although additional studies are clearly needed to better
understand the physiologic changes after kidney donation, the current practice of live kidney donation
should continue to be considered a reasonable and safe modality for addressing the profound shortage in
deceased donor organs.
Article Information
Corresponding Author: Dorry L. Segev, MD, PhD, Department of Surgery, Johns Hopkins Medical
Institutions, 720 Rutland Ave, Ross 771B, Baltimore, MD 21205 (dorry@jhmi.edu).
Author Contributions: Dr Segev had full access to all of the data in the study and takes responsibility for
the integrity of the data and the accuracy of the data analysis.
Study concept and design: Segev.
Acquisition of data: Segev, Taranto, McBride.
Analysis and interpretation of data: Segev, Muzaale, Caffo, Mehta, Singer, Taranto, Montgomery.
Drafting of the manuscript: Segev, Muzaale.
Critical revision of the manuscript for important intellectual content: Segev, Muzaale, Caffo, Mehta, Singer,
Taranto, McBride, Montgomery.
Statistical analysis: Segev, Muzaale, Caffo, Mehta, McBride.
Administrative, technical, or material support: Montgomery.
C.Agnello SE 0124
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 128 of 569 PageID #:
322
Study supervision: Segev.
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
Financial Disclosures: None reported.
Funding/Support: The Organ Procurement and Transplantation Network (OPTN) is supported by Health
Resources and Services Administration contract 234-2005-370011C. To ensure confidentiality of Social
Security number data provided to the OPTN, the Social Security number linkages to Social Security Death
Master File were performed solely by United Network for Organ Sharing staff (including Dr McBride and Ms
Taranto).
Disclaimer: The analyses described herein are the responsibility of the authors alone and do not necessar-
ily reflect the views or policies of the US Department of Health and Human Services, nor does the mention
of trade names, commercial products, or organizations imply endorsement by the US government.
Additional Contributions: Katarina Linden (United Network for Organ Sharing, Richmond, Virginia) pro-
vided advice and data support for the manuscript. Ms Linden did not receive any compensation.
References
1. Poggio ED, Braun WE, Davis C. The science of stewardship: due diligence for kidney donors and kid-
ney function in living kidney donation—evaluation, determinants, and implications for
outcomes. Clin J Am Soc Nephrol. 2009;4(10):1677-168419713294
PubMed | Google Scholar | Crossref
2. Delmonico FL, Dew MA. Living donor kidney transplantation in a global environment. Kidney
Int. 2007;71(7):608-61417290291
PubMed | Google Scholar | Crossref
3. Ibrahim HN, Foley R, Tan L, et al. Long-term consequences of kidney donation. N Engl J
Med. 2009;360(5):459-46919179315
PubMed | Google Scholar | Crossref
4. Delmonico F.Council of the Transplantation Society. A report of the Amsterdam forum on the care
of the live kidney donor: data and medical guidelines. Transplantation. 2005;79(6):(suppl) S53-
S6615785361
PubMed | Google Scholar | Crossref
5. United Network for Organ Sharing Web site. http://www.unos.org. Accessed February 5, 2010
6. Fehrman-Ekholm I, Elinder CG, Stenbeck M, Tyden G, Groth CG. Kidney donors live
longer. Transplantation. 1997;64(7):976-9789381544
PubMed | Google Scholar | Crossref
C.Agnello SE 0125
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 129 of 569 PageID #:
323
7. Garg AX, Muirhead N, Knoll G, et al; Donor Nephrectomy Outcomes Research (DONOR)
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
Network. Proteinuria and reduced kidney function in living kidney donors: a systematic review,
meta-analysis, and meta-regression. Kidney Int. 2006;70(10):1801-181017003822
PubMed | Google Scholar | Crossref
8. Najarian JS, Chavers BM, McHugh LE, Matas AJ. 20 years or more of follow-up of living kidney
donors. Lancet. 1992;340(8823):807-8101357243
PubMed | Google Scholar | Crossref
9. Goldfarb DA, Matin SF, Braun WE, et al. Renal outcome 25 years after donor nephrectomy. J
Urol. 2001;166(6):2043-204711696703
PubMed | Google Scholar | Crossref
10. Okamoto M, Akioka K, Nobori S, et al. Short- and long-term donor outcomes after kidney donation:
analysis of 601 cases over a 35-year period at Japanese single
center. Transplantation. 2009;87(3):419-42319202449
PubMed | Google Scholar | Crossref
11. Andersen B, Hansen JB, Jorgensen SJ. Survival after nephrectomy. Scand J Urol
Nephrol. 1968;2(2):91-945734267
PubMed | Google Scholar | Crossref
12. Friedman AL, Peters TG, Jones KW, Boulware LE, Ratner LE. Fatal and nonfatal hemorrhagic compli-
cations of living kidney donation. Ann Surg. 2006;243(1):126-13016371747
PubMed | Google Scholar | Crossref
13. Johnson EM, Remucal MJ, Gillingham KJ, Dahms RA, Najarian JS, Matas AJ. Complications and risks
of living donor nephrectomy. Transplantation. 1997;64(8):1124-11289355827
PubMed | Google Scholar | Crossref
14. Matas AJ, Bartlett ST, Leichtman AB, Delmonico FL. Morbidity and mortality after living kidney do-
nation, 1999-2001: survey of United States transplant centers. Am J Transplant. 2003;3(7):830-
83412814474
PubMed | Google Scholar
15. Steiner CA, Bass EB, Talamini MA, Pitt HA, Steinberg EP. Surgical rates and operative mortality for
open and laparoscopic cholecystectomy in Maryland. N Engl J Med. 1994;330(6):403-4088284007
PubMed | Google Scholar | Crossref
16. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United
States. N Engl J Med. 2002;346(15):1128-113711948273
PubMed | Google Scholar | Crossref
C.Agnello SE 0126
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 130 of 569 PageID #:
324
17. Lucas FL, Stukel TA, Morris AM, Siewers AE, Birkmeyer JD. Race and surgical mortality in the United
RELATED ARTICLES FIGURES SUPPLEMENTAL CONTENT
States. Ann Surg. 2006;243(2):281-28616432363
PubMed | Google Scholar | Crossref
18. Nathan H, Frederick W, Choti MA, Schulick RD, Pawlik TM. Racial disparity in surgical mortality after
major hepatectomy. J Am Coll Surg. 2008;207(3):312-31918722934
PubMed | Google Scholar | Crossref
19. Sheikh K, Jiang Y, Bullock CM. Effect of comorbid and fatal coexistent conditions on sex and race dif-
ferences in vascular surgical mortality. Ann Vasc Surg. 2007;21(4):496-50417628266
PubMed | Google Scholar | Crossref
20. Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in el-
derly patients. J Am Coll Surg. 2006;203(6):865-87717116555
PubMed | Google Scholar | Crossref
21. Nguyen GC, Laveist TA, Segev DL, Thuluvath PJ. Race is a predictor of in-hospital mortality after
cholecystectomy, especially in those with portal hypertension. Clin Gastroenterol
Hepatol. 2008;6(10):1146-115418928940
PubMed | Google Scholar | Crossref
22. Bay WH, Hebert LA. The living donor in kidney transplantation. Ann Intern Med. 1987;106(5):719-
7273551714
PubMed | Google Scholar | Crossref
23. Schulam PG, Kavoussi LR, Cheriff AD, et al. Laparoscopic live donor nephrectomy: the initial 3
cases. J Urol. 1996;155(6):1857-18598618273
PubMed | Google Scholar | Crossref
24. Ratner LE, Kavoussi LR, Schulam PG, Bender JS, Magnuson TH, Montgomery R. Comparison of la-
paroscopic live donor nephrectomy versus the standard open approach. Transplant Proc. 1997;29(1-
2):138-1399122930
PubMed | Google Scholar | Crossref
View Full Text | Download PDF
C.Agnello SE 0127
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 131 of 569 PageID #:
325
EXHIBIT H
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0128
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 132 of 569
1 of 35PageID 1
#:
H6EHLUMS 326
1 UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
2 ------------------------------x
3 UNITED STATES OF AMERICA,
4 v. 16 Cr. 483 (JSR)
5
STEFAN LUMIERE,
6
Sentence
7 Defendant.
8 ------------------------------x
9 New York, N.Y.
June 14, 2017
10 9:40 a.m.
11
Before:
12
HON. JED S. RAKOFF,
13
District Judge
14
APPEARANCES
15
JOON H. KIM
16 Acting United States Attorney for the
Southern District of New York
17 IAN McGINLEY
DAMIAN WILLIAMS
18 Assistant United States Attorney
19 JONATHAN HALPERN
JONATHAN FRIEDMAN
20 Attorneys for Defendant
21
22
23
24
25
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0129
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 133 of 569
2 of 35PageID 2
#:
H6EHLUMS 327
1 (Case called)
2 THE COURT: Good morning. All right. So the parties
3 have stipulated to a gain amount. This is a stipulation "for
4 sentencing purposes only," whatever that may mean. That a
5 reasonable estimate of the gains resulting from the fraud is
6 between 1.5 million and 3.1 million. I've reviewed that
7 calculation and the basis for it. I find that it is a
8 reasonable calculation. The government also still asserts the
9 possibility of a loss, a larger loss calculation. I've
10 reviewed that calculation, and I don't find it sufficiently
11 adequately supported to adopt. So I will adopt the gain
12 calculation, which means that to the base offense level of
13 seven, there is added an enhancement of 16 points. The parties
14 still disagree as to the other enhancements, the two-point
15 enhancement for ten or more victims and the four-point
16 enhancement for associations with an investment adviser.
17 I'm persuaded by the government's arguments, and so I
18 will add those two enhancements for a total offense level of
19 29, for a guideline range of 87 to 108 months in prison.
20 However, if I did not add those enhancements and adopted the
21 defense position, the total offense level would be 23, and the
22 guideline range would be 46 to 57 months. Excuse me. Sit
23 down, counsel. And my sentence, which is going to be below
24 either of the guideline ranges, would be exactly the same
25 whether those enhancements were added or not. They are totally
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0130
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 134 of 569
3 of 35PageID 3
#:
H6EHLUMS 328
1 irrelevant, as is the gain calculation. It is, of course,
2 relevant how much this was a serious crime, which it clearly
3 was, but all this number-crunching gibberish that constitutes
4 the irrational guidelines is of little or no consequence to
5 this Court. So we will proceed now to hear argument on factors
6 under Section 3553(a).
7 MR. HALPERN: Your Honor, if I may just be heard on
8 the last, on the guidelines point. In conversations with --
9 THE COURT: You would rather my not give a
10 nonguideline sentence?
11 MR. HALPERN: No, your Honor.
12 THE COURT: So let's spend more time on the
13 guidelines, because even though I'm going to give a sentence
14 well below the guidelines, counsel for both sides seem to be of
15 the view, even though I've made that clear repeatedly, that
16 they should spend all their efforts on what is of little or no
17 relevance to this Court. But go ahead, counsel.
18 MR. HALPERN: Your Honor, I well understand that. I
19 well appreciate it, and I understand very well your Honor's
20 point and the tenor of your Honor's comments. They come
21 through loud and clear. I also recognize, as your Honor does,
22 that there is an obligation under the law to do a calculation.
23 THE COURT: I've done it.
24 MR. HALPERN: Yes. And what I wanted to say is that
25 in light of our stipulation, in conversations with the
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0131
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 135 of 569
4 of 35PageID 4
#:
H6EHLUMS 329
1 government yesterday, the government advised that the
2 calculation for the two-level enhancement for greater than ten
3 investors was not applicable and was not pressing. I just put
4 that for --
5 THE COURT: I presided over the trial. I think it is
6 admissible, but it makes absolutely no difference to my
7 sentence.
8 MR. HALPERN: Understood. I just wanted to raise that
9 for your Honor. I hope you'll forgive me for doing what I
10 thought I had an obligation to bring an issue to your Honor's
11 attention.
12 THE COURT: So noted.
13 MR. HALPERN: Thank you, your Honor.
14 On behalf of defendant Stefan Lumiere, we'd like to
15 address several of the 3553(a) factors, including the history
16 and characteristics, the role of the offense, and the special
17 circumstances in the treatment, that we respectfully request
18 the mercy of the Court a lenient sentence.
19 Mr. Lumiere is here and supported by his family, many
20 friends, former colleagues, his parents, and at least one
21 cousin and an aunt and a sibling, his significant other. And
22 your Honor has been witness to the scores of letters -- it's
23 approximately 80 or more now -- of those witnesses who know
24 Mr. Lumiere the longest and the best. And as your Honor is
25 aware that that presentation, that composite portrayal, is very
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0132
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 136 of 569
5 of 35PageID 5
#:
H6EHLUMS 330
1 different from the presentation through the lens of the prism
2 that was presented at trial. I wasn't here for trial, as your
3 Honor is aware, but that's a very different portrait of a man.
4 I understand that -- I know your Honor has commented on the
5 formidable responsibility of imposing a sentence on a fellow
6 human being, and that sentence is imposed based on the whole
7 life of a human being as an individual uniquely, unprecedented
8 to any other matter, with the objective set forth in 3553(a)
9 and the balancing and competing acts.
10 Those witnesses essentially have testified to your
11 Honor. They come from all walks of his life not only his
12 close-knit, loving, embracing family who has instilled in
13 Mr. Lumiere key values that are reflected in the letters of his
14 friends, his former colleagues, his former classmates in Costa
15 Rica at business school.
16 THE COURT: There's absolutely no question that he has
17 wonderful friends. He has a great many people who have
18 attested to the positive side of his character, and I'm going
19 to factor that in in a substantial way in the sentence that I
20 impose. But in some ways that makes his deviation from those
21 characteristics all the more telling. There's really no
22 excuse, because he knew what he was doing was wrong, and that
23 is the Court's calculation -- or, excuse me, determination and
24 also was clearly the jury's. The broader aspects of his
25 characteristics are very important to this Court and, as I say,
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0133
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 137 of 569
6 of 35PageID 6
#:
H6EHLUMS 331
1 favor leniency, but in an ironic way, it also does pinpoint the
2 intentionality and willfulness of his misconduct.
3 MR. HALPERN: I understand your Honor's views. I'm
4 going to turn to those. And, obviously, we're not here to
5 re-litigate the issues or argue inferences from the evidence,
6 and we acknowledge the jury's verdict. And, obviously, that's
7 the reason we're here today in court, and the defendant stands
8 humbly before you for sentencing. We'll turn to that.
9 I just want to identify some of those traits and
10 characteristics that come through and, I agree with your Honor,
11 that stand in very stark contrast to the presentation of the
12 conduct at trial, and they are ones of not only industriousness
13 but integrity, faithfulness, and loyalty. The perception,
14 often too often, that's characterized of Wall Street and the
15 greed of that is completely inapplicable to Mr. Lumiere. And
16 one example that comes through in the letters, and I'm sure
17 your Honor is aware of it, of all things of his character when
18 he had a long history of employment in Wall Street, but when he
19 went with a team, it was the Spears Leeds Kellogg Group,
20 investment group, a team with him that was taken over by
21 Goldman Sachs. And after a couple of years, Goldman Sachs said
22 that Mr. Lumiere so excelled, his diligence, his hard work, his
23 nose to the grindstone, that they were going to offer
24 Mr. Lumiere solely the position, and he declined that without
25 Goldman Sachs taking on his group. Goldman Sachs declined to
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0134
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 138 of 569
7 of 35PageID 7
#:
H6EHLUMS 332
1 do that, and Mr. Lumiere, as character standing up for his team
2 at great self-sacrifice, declined that offer and went on. And
3 had he accepted that offer, we may very well have been before
4 your Honor today.
5 I appreciate that also the picture that you have of
6 Mr. Lumiere, who has so dedicated to his profession, to the
7 industry, to financial world, that's lost, that's forfeited.
8 And with all of that that comes clear is that he, like other
9 human beings, is flawed. Mr. Lumiere himself has many troubled
10 issues, a number of exceptional issues that your Honor is aware
11 of through the presentence report, through some of the letters,
12 Exhibit B and Exhibit C to the defendant's sentencing
13 submission. They warrant serious attention and treatment, and
14 so that's part of the entire picture of the human being,
15 someone who your Honor has recognized has a whole life of hard
16 work --
17 THE COURT: I certainly take account of the special
18 circumstances that you're alluding to. I assume you don't want
19 to get into that in more detail here in the record.
20 MR. HALPERN: I think that's right. I make allusion
21 to it. They're extensive. I won't go beyond that, but they're
22 very serious.
23 THE COURT: I just want to make note, for the record,
24 that I have taken that into account, but unless you want to, I
25 don't see the need to elaborate on that.
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0135
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 139 of 569
8 of 35PageID 8
#:
H6EHLUMS 333
1 MR. HALPERN: I'll go into a little more detail later,
2 but that's right, your Honor.
3 Also what comes through is the scrupulousness of
4 Mr. Lumiere in other positions, of his former colleagues and
5 friends who attested to his work. So I agree with your Honor's
6 assessment that there's a disconnect from the evidence, the
7 conduct that was portrayed and presented. One of the authors
8 of the letter characterized Mr. Lumiere as scrupulous in his
9 behavior. So I respectfully submit to your Honor, in
10 considering the sentence to fashion, that Mr. Lumiere is not
11 and does not represent or reflect the unflattering picture that
12 too often we unfairly and reflexively have the common view of
13 the caricature and stereotype of someone working at a hedge
14 fund or in Wall Street.
15 THE COURT: I agree with you. I don't share that
16 stereotype. Every case is individual, and every person who
17 works in any field of endeavor, there are good folks and bad
18 folks, and people in between. But what I think is
19 unquestionable, and I know you maintain your position, but just
20 so that the record's clear, this Court totally agrees with the
21 jury's verdict. In the Court's view, the proof was
22 overwhelming that the defendant committed the crimes he's
23 convicted of. And that's not so unusual. You see again and
24 again otherwise good people who, for one reason or another,
25 succumb to temptations and commit serious crimes. It's
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0136
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 Filed
Document 115 03/11/26 PagePage
Filed 06/27/17 140 of 569
9 of 35PageID 9
#:
H6EHLUMS 334
1 important to remember the broader aspects of their life, all
2 the laudable characteristics that you have so eloquently
3 referred to, but I don't want anyone to be under the
4 misimpression that I had any view of the misconduct here other
5 than that it was willful, intentional, and proven
6 overwhelmingly.
7 MR. HALPERN: I understand your Honor's view. And,
8 again, we're not engaging in this. We're preserving all
9 rights.
10 THE COURT: Of course.
11 MR. HALPERN: Obviously, your Honor is aware of the
12 appeal, and I appreciate your Honor's comments.
13 Before I go on to the role and what I think is the
14 total disconnect between a full life of this human being and
15 what was portrayed at trial, I just would want to say that this
16 lifetime where Mr. Lumiere on his own, great sacrifice,
17 generosity, jumping in, interceding in positions where he had
18 no obligation to do so, his devotion as a member of his family,
19 close to his parents and to his nieces, that he has just
20 voluntarily taken on this role with great relish, and he has
21 been in his life in so many ways a role model in so many
22 different traits and characteristics. He's a good soul, an
23 honorable soul. I'll move on to the role in the offense.
24 When I had the good fortune of sitting in the
25 government's chair for, really, 15 years --
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0137
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 141 10
of 569 PageID #:
of 35 10
H6EHLUMS 335
1 THE COURT: But you've repressed all that.
2 MR. HALPERN: I'm sorry?
3 THE COURT: But you've repressed all that.
4 MR. HALPERN: No, I've hopefully incorporated and
5 softened and moderated and tempered my views. One of the
6 things I continue to appreciate and I learned when I was in the
7 office is that for investigations of fraud, white-collar crime,
8 and other crimes, but especially white collar is you follow the
9 money. You look for the trail of the money. Where does it
10 lead, who's benefiting the most, and who is it, who's
11 exploited, who's taken advantage? Even if a jury will find
12 that there was criminal culpability, there are misjudgments
13 that are made. I'm not -- I acknowledge the jury's verdict and
14 I understand your Honor's comments, but you follow the money
15 and that's what you look to.
16 For Mr. Lumiere's role in this offense, first, it's
17 absolutely clear Mr. Lumiere was not portfolio manager of the
18 credit fund of Visium. Full stop. He was, along with
19 something like a dozen others, a portfolio manager of the
20 global fund which had nothing to do with the charges in the
21 trial in the case before your Honor. Mr. Lumiere was an
22 analyst in the credit fund, and he was from time to time on an
23 ad hoc basis asked to perform various duties. And he had
24 expertise in restructuring --
25 THE COURT: I'm not sure any of this is relevant, but
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0138
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 142 11
of 569 PageID #:
of 35 11
H6EHLUMS 336
1 for what it's worth, I think there is evidence that he
2 functionally served as a portfolio manager regardless of
3 whatever title may have been involved. But it's all, in my
4 view secondary. He played, intentionally played, a role in
5 falsifying net asset value, in falsifying what was presented as
6 being the reality of the situation. And it's relevant what
7 level he did that at, but it's more relevant that he did it.
8 MR. HALPERN: I understand your Honor's view of the
9 conduct. I take that. I do think it's relevant because he was
10 exploited. It was Chris Plaford who was the only one,
11 functionally or not, who ran that fund. It was Chris Plaford,
12 by his own testimony, who interacted with investors. That's
13 what the focus of the criminal activity was with a claim that
14 investors were misled. It was Mr. Plaford who said that it
15 wasn't Mr. Lumiere who had anything to do with investors. In
16 fact, Mr. Plaford said he didn't trust Mr. Lumiere to do
17 anything. He was the one who directed Mr. Lumiere with the
18 quotes. It was Mr. Plaford who prepared the overrides. I
19 mean, just going down, down, down. Yes, Mr. Lumiere was
20 exploited. He was used.
21 The conduct was before your Honor, but I think context
22 is important; relativity is important. Following the money,
23 Mr. Lumiere received a fraction of the compensation. His
24 annual salary, enviable for most of America, in this context
25 was relatively small at $200,000. Mr. Plaford --
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0139
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 143 12
of 569 PageID #:
of 35 12
H6EHLUMS 337
1 THE COURT: I don't think you can have it both ways
2 with Mr. Plaford's testimony. He testified that Lumiere was "a
3 senior analyst/portfolio manager on the credit team" and that
4 Lumiere managed on average "over $100 million." Thorell also
5 testified that Lumiere was "a portfolio manager in charge of a
6 section or subsection of the credit fund with a certain
7 strategy specific to him." Now, I don't have to adopt those
8 specific items of testimony because, as I tried to express to
9 you a minute ago, I think this is somewhat a peripheral issue.
10 But I don't think you can say: Oh, accept Plaford's testimony
11 for point X, but don't accept it for point Y.
12 MR. HALPERN: Well, your Honor, I do recognize
13 Mr. Plaford pled guilty to seven felonies and is a cooperating
14 witness with the government on behalf of the government, and
15 Mr. Thorell had immunized testimony and struggled to
16 acknowledge certain of his conduct and what was the import of
17 that at that time. I will say I'm aware -- I don't know if the
18 Court still gives this instruction -- but elsewhere, you know,
19 you evaluate the testimony of the witness, and sometimes it's
20 like a slice of burnt toast. Sometimes you toss the whole
21 burnt toast away, and other times you're going to carve out the
22 toast. So I think it can be appropriate to --
23 THE COURT: I haven't used that analogy, but I'll
24 certainly keep it in mind for the future. But I understand
25 your point.
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0140
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 144 13
of 569 PageID #:
of 35 13
H6EHLUMS 338
1 MR. HALPERN: You don't have to be wholesale. In any
2 event, I vigorously contest the notion that Mr. Lumiere
3 functioned as anything like a credit fund portfolio manager
4 given what he was actually doing.
5 Again, back to the money, Plaford had something like
6 ten times as much compensation as Mr. Lumiere. It was Plaford
7 along with Jake Gottlieb, the CIO of the fund, who determined
8 bonus, and Plaford admitted that he received no bonus. It was
9 his base $200,000 salary. The disconnect is this, your Honor:
10 It's that Mr. Lumiere had no motivation to do what the jury
11 found, what was presented, and what your Honor inferred. There
12 was no financial motivation. He received no bonus. He was in
13 an untenable situation in especially these times. His sister
14 at the time was married to Mr. Gottlieb. They were going
15 through a deterioration in their relationship which led to a
16 vitriolic and contentious divorce. Mr. Lumiere was not
17 well-respected, was not well-treated, was not valued. He was
18 exploited. He had no future there. There was no direct bonus
19 or compensation from the scheme. He received no gain from the
20 offense in this. It was coconspirators who received the gain
21 through fees, performance fees, that came in.
22 I know your Honor sometimes refers to indirect
23 benefits. That, well, he didn't receive compensation or a
24 bonus in year one or year two, but there was a long-term
25 prospect that if he did well, it would promote the well-being
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0141
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 145 14
of 569 PageID #:
of 35 14
H6EHLUMS 339
1 of the firm, and he would receive incidental or derivative
2 benefits. Not happened in this case. He had no future there.
3 It was a completely untenable position to be there. He
4 couldn't wait to get out, and he got out.
5 When he left in April or May of 2013, did the scheme,
6 as the government charged, proved, stop? Not at all. It
7 continued unabated. It didn't miss a beat. It didn't miss
8 Mr. Lumiere. So I think that is very important. He was a
9 hapless soul. He was, as we said, someone who was a working
10 stiff. We understand what the conduct showed to your Honor and
11 to the jury. We respectfully submit, you know, the defense
12 we're not going to argue here. We have those issues. It was
13 not presented, and the government even argued that it was just
14 argument. So we acknowledge the jury's verdict and respect
15 your Honor's views, but in the context of what happened, he was
16 the low person, and he was taken advantage of.
17 I'd like to turn to the last section, given that
18 Mr. Lumiere essentially forfeited his career that he worked
19 very hard for, studying for an MBA, learning a second language
20 in a foreign country, earning that master's degree in a foreign
21 language. He's given that up. His role in the securities
22 world is over. It's finished. He will be deterred, and
23 there's no issue as to whether this will recur. He's not a
24 danger to society by any stretch, and so there's no further
25 deterrence that way. I would just like --
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0142
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 146 15
of 569 PageID #:
of 35 15
H6EHLUMS 340
1 THE COURT: Well, the main issue in white-collar cases
2 is often general deterrence, and there is a body of literature
3 largely ignored by the sentencing commission but which suggests
4 that, on the one hand, heavy sentences do not serve added
5 deterrent effect in white-collar cases, but that, on the other
6 hand, some meaningful prison time does serve a major deterring
7 effect in white-collar cases because it sends the message to
8 others similarly situated that you can't buy your way out of
9 this.
10 MR. HALPERN: I understand that's a factor.
11 Certainly, that's to be considered, along with the seriousness
12 of the offense and other objectives. Under these really
13 extraordinary circumstances for Mr. Lumiere personally,
14 individually, those other factors that make some reference to
15 that, when your Honor considers that, whatever punishment your
16 Honor imposes is going to be disproportionately harsh because
17 of the circumstances Mr. Lumiere finds himself in as outlined
18 in the PSR, including paragraphs 119 and 120.
19 THE COURT: Based on my own assessment of some of the
20 materials you presented in that regard, I think one could
21 quibble here or there. I essentially accept the basic picture
22 that's been portrayed there. So I don't think we need to get
23 into that in great detail, unless you want to. So I understand
24 the argument that you're making there.
25 MR. HALPERN: I would just say he is, because of those
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0143
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 147 16
of 569 PageID #:
of 35 16
H6EHLUMS 341
1 conditions, more vulnerable as a potential inmate. And given
2 the circumstances, that there are triggers that could generate
3 dire, even life-threatening conditions, as your Honor is aware,
4 and --
5 THE COURT: That's true. On the other hand, depending
6 on the sentence imposed, if he were sentenced, he would
7 probably serve his time in a facility where those kinds of
8 pressures would be less than they would be in a more onerous
9 prison facility.
10 MR. HALPERN: For example, a community house, halfway
11 house, would have -- serve those --
12 THE COURT: Actually, I'm not sure. This is really
13 getting off the subject and not worth talking about it, but
14 there are community houses and community houses. Some of them
15 are actually worse than the low-level prisons that are offered
16 usually to white-collar offenders because they are populated
17 often by serious street criminals, violent street criminals who
18 are on their way back to society and who, in fairness, are
19 being given the opportunity to serve the last portion of their
20 sentence in a halfway house but are not really the best company
21 for someone situated like your client.
22 MR. HALPERN: That's an argument for a probationary
23 sentence in this case.
24 THE COURT: Or for a prison facility of a low level.
25 MR. HALPERN: I understand your Honor's point.
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0144
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 148 17
of 569 PageID #:
of 35 17
H6EHLUMS 342
1 Finally, in closing -- and, actually, your Honor, with
2 respect, I hate to revert to this, but could we mark as a court
3 exhibit the agreed stipulation between the parties --
4 THE COURT: Sure.
5 MR. HALPERN: -- on the gain?
6 THE COURT: Yes.
7 MR. HALPERN: Thank you, your Honor.
8 THE COURT: You want to hand that up. Just give it to
9 my courtroom deputy. She'll mark it as Court Exhibit 1 to
10 today's proceeding.
11 MR. HALPERN: Thank you.
12 So on all of those factors and the need for, I think I
13 would say, tempering the deterrence and other factors,
14 including respect for the law, just punishment, the seriousness
15 of the offense, with the specific and general deterrence that
16 apply here, the other factors that pertain to the defendant,
17 including that a sentence in custody would expose him to
18 vulnerabilities, including physical issues that have been
19 identified, that they would only exacerbate him, and, as I
20 said, it would be disproportionate. And I know your Honor will
21 take that into account in fashioning an appropriate sentence.
22 I would just close on this part, your Honor, by saying
23 here is a good soul. He has been a role model. The life that
24 has at least been portrayed in the 80-or-so witness portrayals
25 before your Honor points to a very decent and loving and
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0145
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 149 18
of 569 PageID #:
of 35 18
H6EHLUMS 343
1 devoted, son, sibling, friend, colleague, and he has a lot to
2 offer society. He's given up his chosen career. And we just
3 ask that his opportunities, to the extent possible by your
4 Honor, be permitted to grow, to flourish, and not snuff out --
5 the opportunities snuffed out so he receives the attention and
6 the treatment to get back on his feet, not appear before your
7 Honor in any like circumstances, but be really a beacon and a
8 model for others and to show that, you know, his life can make
9 a difference.
10 So with respect, your Honor, I would humbly seek the
11 Court's leniency and mercy in imposing a sentence on
12 Mr. Lumiere.
13 THE COURT: Thank you very much.
14 Let me hear from the government.
15 MR. McGINLEY: Thank you, your Honor. Your Honor
16 presided over this trial, and you have our submission, so I
17 won't belabor the points. I'll note just a few things. It is
18 important to remember that this crime was the defendant's
19 brainchild. It started when his investments started to tank,
20 and he then reached out. He got his friends -- there's no
21 dispute about that, Vandersnow and Brook. They were the
22 defendant's friends -- he got them involved in the scheme, and
23 it started.
24 THE COURT: And the motivation, you would suggest, is
25 that he saw that his own business acumen was being questioned
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0146
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 150 19
of 569 PageID #:
of 35 19
H6EHLUMS 344
1 and that his position, in effect, was not living up to his past
2 performance, and so that's what led him to commit the crime.
3 Is that your view?
4 MR. McGINLEY: That's fair, your Honor. There are
5 other reasons, right, to maintain his reputation, and there was
6 plenty of testimony that but for this, the defendant would have
7 been fired. So I would just note that, your Honor, the crime
8 went on for years, deceptive act after deceptive act. The
9 defendant sent thumb drives to the brokers. He had them
10 communicate on personal cell phones to avoid detection.
11 I would also note, your Honor, there are recordings in
12 this case that your Honor's heard. I'll bring attention to
13 two. The first on his knowledge of the scheme is when he talks
14 to his friend PB as the scheme is ending, and he says, "By the
15 way, don't tell anyone about the F'ing mismarking of the book."
16 He knew exactly what was going on because he started the
17 scheme. The other, and I think this goes to a number of points
18 that defense counsel just made, is that chilling recording
19 where he shows just how much he knows the scheme is wrong and
20 the magnitude of it because he says -- and again, this is
21 Government Exhibit 1222. Thorell tells him, "Well, what do you
22 want to do with this information we have about the crime?"
23 And he says, "Well, first, we can extort it. I'd love
24 to be able to go to him and say, 'Listen, Jake, Chris. Give us
25 a hundred million between the both of you.'"
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0147
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 151 20
of 569 PageID #:
of 35 20
H6EHLUMS 345
1 Now, that, your Honor, is not a hapless soul. That's
2 not a working stiff. That is a man who knows exactly what he
3 did, and he's trying to figure out a way for him to even gain
4 from that crime. That is what he was thinking then.
5 Hopefully, this experience has changed him, but that was the
6 real Stefan Lumiere you heard in those recordings too.
7 THE COURT: Let me ask a more technical question. Do
8 you agree that under the Honeycutt case that came down a few
9 days ago, that forfeiture is no longer appropriate in this
10 case?
11 MR. McGINLEY: Your Honor, I've consulted with my
12 office on that. Main justice is still formulating a guidance
13 on that. Honeycutt, I've read it. It's a drug case. We're
14 not seeking forfeiture under the drug statutes. What I would
15 ask, and, obviously, your Honor will do what your Honor does,
16 is to have you calculate -- we advance two positions on
17 forfeiture. That, at the very least, he should forfeit his
18 salary, but the other position is that he's jointly and
19 severally liable for the performance fees. And what we would
20 ask is your Honor to make a finding on both and to delay a
21 final pronouncement.
22 THE COURT: Well, I wonder how much -- again, as a
23 practical matter, one of my many, many, many problems with the
24 guidelines is they are so calculated in the abstract without
25 reference to the particulars of a given situation, whereas I
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0148
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 152 21
of 569 PageID #:
of 35 21
H6EHLUMS 346
1 think most judges prefer to be practical. So Honeycutt does
2 not affect restitution, does it?
3 MR. McGINLEY: It does not.
4 THE COURT: Which is, what, 23 million-plus in this
5 case? We may want to argue about the amount, but it's some
6 large amount.
7 MR. McGINLEY: Well, if we go by gain, your Honor --
8 THE COURT: It would be 3 million, or whatever.
9 MR. McGINLEY: It would be, but we don't have the
10 identified victims.
11 THE COURT: What about do I not have the ability to
12 impose a fine of up to $5 million?
13 MR. McGINLEY: You do, your Honor.
14 THE COURT: OK. Anyway, anything else you wanted to
15 say?
16 MR. McGINLEY: Just two very quick points. To your
17 Honor's point on general deterrence, I think that is very
18 applicable here. These are crimes are very hard to detect.
19 The crime here was simple, but the underlying conduct, the
20 underlying business, very complex, very hard to make these
21 cases. And for that reason, we think a stronger sentence is
22 necessary.
23 THE COURT: Let me hear from defense counsel and then
24 from the defendant if he wishes to be heard.
25 MR. HALPERN: Thank you, your Honor. Your Honor, the
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0149
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 153 22
of 569 PageID #:
of 35 22
H6EHLUMS 347
1 Honeycutt forfeiture is inapplicable here. They say it's a
2 narcotics statute, but the principle applies that there should
3 be no joint and several liability here. Mr. Lumiere
4 received --
5 THE COURT: Let's assume I agree with you on that.
6 What do you think is the right calculation of restitution?
7 MR. HALPERN: The right restitution, the right
8 calculation of restitution -- first of all, separate concept --
9 but zero, and that's because there are no actual victims.
10 There's no actual loss. He stipulated to gain. That's an
11 inappropriate measure for restitution, period.
12 THE COURT: All right. So assuming I were to agree
13 with you on that and assuming that you persuaded me that less
14 prison time than might otherwise be appropriate should be
15 imposed, does not that argue for a substantial fine?
16 MR. HALPERN: In lieu of the forfeiture?
17 THE COURT: No, no, not in lieu of the forfeiture.
18 It's a separate issue.
19 MR. HALPERN: OK.
20 THE COURT: But the issue is you've been eloquently
21 arguing to me that, in effect, prison would be particularly
22 difficult in his case because of vulnerabilities that he has,
23 and so forth. I don't want you to be under a misimpression.
24 There's going to be some prison time in this case. But
25 assuming that I were to reduce it from what I otherwise would
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0150
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 154 23
of 569 PageID #:
of 35 23
H6EHLUMS 348
1 impose, punishment is still an important function, and should I
2 therefore not consider a substantial fine?
3 MR. HALPERN: I agree, punishment is obviously a
4 factor, but I disagree with a substantial fine. It's also with
5 respect to this defendant's finances. He's not been working
6 other than what he's trying to cobble together in the
7 construction renovation --
8 THE COURT: A fine would be imposed prospectively,
9 that is to say, a certain amount now, but a certain amount as a
10 percentage of future earnings.
11 MR. HALPERN: Well, I understand that, but given the
12 relative and comparative role that he had, and he earned
13 $200,000 when others were earning millions of dollars from
14 Mr. Plaford, I don't think that's appropriate as to this
15 defendant.
16 THE COURT: No, now you're confusing restitution and
17 fine. The fine has nothing to do with how much he earned. The
18 fine has to do -- it's a form of punishment, and it seems to me
19 that if I buy into your argument that there should be less
20 prison time for all the factors you've mentioned, then it's
21 important that I temper that with a less onerous but still
22 meaningful punishment in the form of a substantial fine.
23 MR. HALPERN: I understand, your Honor, that a
24 criminal fine is part of the sentence your Honor can impose,
25 but I must say I don't think that you can give with one hand
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0151
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 155 24
of 569 PageID #:
of 35 24
H6EHLUMS 349
1 and take away with the other. I think it should be
2 treated that there are separate interests for custody, and I
3 understand this is a crime of fraud and there's a financial
4 component to it --
5 THE COURT: I'm sorry. It's obviously not some sort
6 of formula, but the same section 3553(a) factors that operate
7 in connection with prison also operate in connection with a
8 fine, and missing from a fine calculation are some of the
9 mitigating factors that you've argued for because vulnerability
10 becomes irrelevant. So applying the Section 3553(a) factors to
11 the fine, is it not the case that there's an argument for a
12 substantial fine?
13 MR. HALPERN: We disagree with "substantial fine"
14 because I think your Honor has to look also at the financial
15 condition of the defendant, which is apart from --
16 THE COURT: I don't understand that argument if the
17 fine is calculated as a percentage of his gross monthly income.
18 So if he remains impecunious, he pays very little, and if he
19 hits it rich, he pays a lot. So what does his present economic
20 state have to do with it?
21 MR. HALPERN: As I understood the imposition of the
22 fine, that that is a factor, when a fine is imposed, it's at
23 the time of sentence and a kind of snapshot.
24 THE COURT: Well, that's if the fine is you must pay
25 it now, but I'm talking about another.
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0152
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 156 25
of 569 PageID #:
of 35 25
H6EHLUMS 350
1 MR. HALPERN: I appreciate what your Honor's saying.
2 I just don't think that -- I understand an appropriate but a
3 small fine, given all of the factors that we've identified,
4 would be appropriate, including his role relatively and the
5 conduct that your Honor saw.
6 THE COURT: All right. Let me hear from the defendant
7 if he wishes to speak.
8 MR. HALPERN: I'm sorry. On the forfeiture, though,
9 am I correct, your Honor, that --
10 THE COURT: I'm not going to impose forfeiture, so you
11 don't need to argue it.
12 MR. HALPERN: Thank you, your Honor.
13 THE DEFENDANT: Your Honor, thank you for hearing me
14 today, and I just --
15 THE COURT: You need to bring that microphone a little
16 closer to you.
17 THE DEFENDANT: Can you hear me? Yeah, I prefer to
18 read this if I may.
19 THE COURT: You might as well sit down so you can get
20 right up to that microphone.
21 THE DEFENDANT: Thank you. I understand I've been
22 convicted. I understand the process involved in the
23 sentencing, including the Court's role in determining a
24 punishment. I respectfully ask your Honor consider these other
25 factors about me when you decide what kind of sentence to
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0153
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 157 26
of 569 PageID #:
of 35 26
H6EHLUMS 351
1 administer.
2 I'm blessed with the support of my friends and family,
3 many of whom are here today. Others who were not able to
4 attend today have written letters to your Honor and offer their
5 views about my character and the type of person I am. I
6 appreciate the time that your Honor has taken in reviewing my
7 submissions and the time your Honor has taken in reviewing my
8 character letters from family and friends who know me best, and
9 in so doing, you're able to see a more full picture of who I am
10 as a person than the way I was presented in the trial.
11 I've studied long and hard to enter the field of
12 finance, pursuing an MBA in a foreign language. I participated
13 and passed my CFA program, which is a long process. To achieve
14 this, I operate on very little sleep, countless hours, and now
15 in one fell swoop all of my studies and work and
16 accomplishments are for nothing. The career path that I had
17 chosen has been shuttered; and, most importantly, the
18 reputation that I worked so hard for to build is ruined. My
19 dreams of running my own investment company are over, but I
20 know I need to adapt and I need to be determined to find a way
21 to rebuild myself.
22 I entered into the field of real estate and
23 construction, since I was unable to return to my field of
24 choice. I'm just getting started in this and hope to be able
25 to return to this career and go on with my life and hopefully
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0154
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 158 27
of 569 PageID #:
of 35 27
H6EHLUMS 352
1 have the opportunity to start a family someday.
2 What hurts me most about this experience is the
3 traumatic impact on my family, especially my mother who is sick
4 and has to deal with her health issues as well as my situation;
5 my father, a practicing physician in New York who was raised in
6 a small town in Georgia called Dalton and worked hard his whole
7 life just to be deeply embarrassed in having his family name
8 dragged through the mud in a very public setting. Most of all
9 I'm saddened by the pain my sister has been suffering while
10 dealing with a never-ending and contentious divorce and its
11 ultimate impact on her children.
12 I've always considered myself to be a family man, a
13 strong man, a rock in the family. I always said it was my
14 mission to be available for my family no matter what and
15 whatever they needed of me. At my father's birthday party last
16 night, I promised my niece I would continue to be there for
17 her. I hope I will be able to keep my promise to her, continue
18 to be there for my family and friends, just as they have been
19 here for me in support during this most trying time in my life.
20 As I stand before -- or sit before your Honor with
21 humbleness and respect, I ask for the Court's mercy and
22 leniency in deciding the sentence. Thank you, your Honor.
23 THE COURT: Thank you very much.
24 Let me begin on one sort of side note, but I can't
25 help but noting that this case once again demonstrates the
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0155
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 159 28
of 569 PageID #:
of 35 28
H6EHLUMS 353
1 absurdity of the sentencing guidelines. The sentence is driven
2 largely by the gain amount, but there are other adjustments of
3 a more technical nature. And under the adjustments that the
4 government originally argued for and I think are so supported
5 by the evidence, the guideline sentence would have been eight
6 years or more, which is just ridiculous, absurd, barbaric in
7 some respects in connection with someone like Mr. Lumiere. But
8 even under the defense view of those adjustments or the middle
9 position that apparently was acceded to by the government,
10 though not by the Court, you still are talking about four to
11 five years under the guidelines.
12 These draconian penalties bear no relationship, in the
13 Court's view, to any of the factors set forth in Section
14 3553(a): just punishment, the nature of the person's offense,
15 and the nature of the person's character, the need for specific
16 and general deterrence or not, and so forth. It is a terrible
17 thing that this country's criminal legal system has become so
18 punitive. I mean, Mr. Lumiere is lucky that he's a
19 white-collar defendant when one considers the kinds of
20 sentences that courts are often forced to impose by mandatory
21 minimums, and the like, on people who have none of his
22 advantages, but even as to him, these guideline sentences would
23 be much more typical of a brutal regime than of a proud
24 American legal system.
25 Now, having gotten that off my chest, so to speak,
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0156
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 160 29
of 569 PageID #:
of 35 29
H6EHLUMS 354
1 let's turn to the individual before the Court. So counsel for
2 the defendant has eloquently, both in his oral presentation and
3 in his excellent papers, made a good case for the claim that in
4 many respects Mr. Lumiere has led a laudable life, one of which
5 he and the many people who are here to support him can be
6 proud, and also that he suffers from certain psychological
7 vulnerabilities that would make him particularly -- that would
8 raise certain possible dangers or hardships associated with
9 prison time that would not necessarily be true of other
10 similarly situated individuals. The Court accepts all that.
11 More than accepts it, takes that very much into account.
12 But, on the other hand, the Court cannot ignore the
13 fact that, as the government I think so correctly points out,
14 Mr. Lumiere embraced this fraudulent scheme, was a highly
15 significant part of the scheme, and did so not aberrationally
16 one day or one week, but for years, for months. And even when
17 he was on the verge of being caught, sought ways to turn the
18 scheme to his further advantage through that attempt at
19 blackmail. This is not the Mr. Lumiere that the people who
20 have come to support him know. They, for the most part, or
21 perhaps all, were not present to hear the testimony, but the
22 testimony and the tapes and the evidence was overwhelming and
23 showed a Mr. Lumiere who had no compunctions about lying and
24 cheating, and that's very much the Mr. Lumiere who exists side
25 by side with the Mr. Lumiere who has so many positive traits.
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0157
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 161 30
of 569 PageID #:
of 35 30
H6EHLUMS 355
1 So there is no doubt in the Court's mind that not only
2 as a matter of general deterrence but also just as a matter of
3 just punishment that prison time is required here. I came into
4 the Court this morning thinking that even after giving all
5 deference to all the many positive factors that defense counsel
6 had raised, that a sentence of two years was the right
7 sentence, but counsel has convinced me that a slightly less
8 sentence is called for here. So the sentence of the Court is
9 that the defendant is sentenced to a year and a half, to 18
10 months, in prison, concurrent on all counts. No forfeiture
11 will be imposed. Restitution in the amount of his salary which
12 was, what, 300,000? Someone have that exact figure here?
13 MR. McGINLEY: 200,000.
14 THE COURT: 200,000. Restitution in the amount of
15 200,000 will be imposed, and a fine of $1 million to be paid as
16 15 percent of his gross monthly income beginning with the
17 second month after he is released from prison. He will also be
18 sentenced to three years of supervised release to follow
19 imprisonment.
20 The terms of supervised release are, first, the
21 mandatory conditions that he will not commit another federal,
22 state, or local crime; that he will not unlawfully possess a
23 controlled substance; that he will cooperate in the collection
24 of DNA; and that he will make restitution in accordance with
25 the schedule just set. The drug testing condition, however,
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0158
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 162 31
of 569 PageID #:
of 35 31
H6EHLUMS 356
1 will be suspended based on the Court's determination that he
2 poses a low risk of future substance abuse.
3 There will also be imposed the standard conditions of
4 supervision 1 through 13. They appear on the face of the
5 judgment and will be gone over with the defendant by the
6 probation officer when he reports to begin his period of
7 supervised release, which he must do within 72 hours of his
8 release from prison, and he will be supervised by the district
9 of his residence. There are other special conditions
10 recommended by the probation office, but I don't think they're
11 necessary. Finally, there's a special assessment of $300 which
12 is mandatory and must be paid.
13 Now, before I advise the defendant of his right of
14 appeal, anything else that counsel wants to raise for the
15 Court? First, anything from the government?
16 MR. McGINLEY: No, your Honor.
17 THE COURT: Anything from the defense?
18 MR. HALPERN: I'm sorry, your Honor, respectfully, if
19 I just may be heard with respect to restitution, and I
20 apologize to your Honor if I misheard. I had thought your
21 Honor was saying earlier in response to my inquiry there was
22 going to be zero restitution. It's also, I would respectfully
23 submit, not applicable here because of gain and not actual loss
24 and identifiable victims. So --
25 THE COURT: No, that's not a frivolous position.
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0159
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 163 32
of 569 PageID #:
of 35 32
H6EHLUMS 357
1 What's the government's position?
2 MR. McGINLEY: Your Honor, I think, just to be safe,
3 the government would forgo the restitution.
4 THE COURT: So no --
5 MR. McGINLEY: If I just --
6 THE COURT: Not impose the restitution.
7 MR. McGINLEY: And if I just may, just for the record,
8 because sometimes these proceedings wind up in other
9 proceedings, the government does not concede that there was no
10 actual loss to these victims, but it has not been finally
11 determined.
12 THE COURT: The government's position, as was very
13 eloquently put forth in its many submissions, was that there
14 was huge loss, but I have not been persuaded that the
15 methodology is sufficiently accurate to permit that
16 calculation, but the government fully maintains its rights.
17 And with respect to forfeiture, I understand the government, if
18 not in this case but certainly in some cases, is going to try
19 to narrow Honeycutt, and all your rights are preserved. So
20 we'll just leave it with the fine so far as the financial
21 aspects of this sentence are concerned.
22 Anything else?
23 MR. HALPERN: Yes, your Honor, if I may, two things --
24 three things. First thing, if I may, in terms of reporting
25 recommendation, if I could request your Honor, understanding
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0160
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 164 33
of 569 PageID #:
of 35 33
H6EHLUMS 358
1 that it's limited, but would request that your Honor recommend
2 that Mr. Lumiere report to FCI Otisville given the proximity to
3 his family.
4 THE COURT: Yes, I will recommend that. As you
5 understand, I'm sure he understands, I can't order that; I can
6 only recommend it. Otisville is frequently sought by many
7 similarly situated defendants, and they can't accommodate
8 everyone who wants to go there. But I certainly think it would
9 be appropriate in his case, and I will recommend it.
10 MR. HALPERN: And also because of the relatively fewer
11 strictures that may not trigger some of the conditions that we
12 referred to.
13 THE COURT: Agree.
14 MR. HALPERN: And this may be out of order, but I do
15 have an application for bail pending appeal. But also if there
16 is reporting, would request that that date be Tuesday,
17 September 12, in light of the various factors we discussed.
18 THE COURT: I have no trouble with Tuesday,
19 September 12, as the reporting date, 2:00 p.m. on September 12
20 to the designated institution.
21 The government's not seeking remand at this time, are
22 you?
23 MR. McGINLEY: We're not seeking remand now, but we do
24 oppose bail pending appeal. I don't know that that's ripe
25 right now.
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0161
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 165 34
of 569 PageID #:
of 35 34
H6EHLUMS 359
1 THE COURT: No, I don't think it's ripe either. So
2 when it becomes ripe, it will ripen.
3 MR. HALPERN: I'm sorry. Your Honor's not willing to
4 hear argument at this point on that issue, bail pending appeal;
5 do I understand that?
6 THE COURT: Correct.
7 MR. HALPERN: Would it be possible to set a schedule
8 with your Honor when we can make those arguments?
9 THE COURT: First thing you have to do is file your
10 notice of appeal. The second thing is you're going to have to
11 be in a position to tell me what your arguments are on appeal.
12 So when you're ready to do all that -- he's free till then.
13 He's free until he reports to the prison unless I order
14 otherwise. So when you're ready, convene a call with the
15 prosecutor, and we'll set a schedule.
16 MR. HALPERN: Thank you, your Honor.
17 THE COURT: All right.
18 MR. HALPERN: One other, in terms of conditions of
19 bail, I take it that there wouldn't be any less restrictive
20 measures with respect to travel?
21 THE COURT: The bail conditions will be the same as
22 they are now.
23 MR. HALPERN: Your Honor, last point, a little bit of
24 housekeeping note. I just raise this. We weren't trial
25 counsel, and we've worked with the good graces of our
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0162
Case 2:24-cr-00366-NJC Document
Case 1:16-cr-00483-JSR 24-1 115
Document Filed 03/11/26 PagePage
Filed 06/27/17 166 35
of 569 PageID #:
of 35 35
H6EHLUMS 360
1 predecessor, Mr. Creizman's office, to obtain discovery from
2 the government. It's been a long process. We've identified a
3 number of government productions that we just do not have, and
4 so I've spoken with Mr. McGinley. I understand that
5 Mr. McGinley is undertaking to provide us with those copies
6 that had previously been provided to Mr. Creizman. I just
7 wanted to raise that with the Court. We hope that your Honor
8 would have jurisdiction over that matter as well. I don't
9 anticipate any resistance, but look forward to the production
10 from the government.
11 THE COURT: All right. So, Mr. Lumiere, you have a
12 right to appeal the sentence. Do you understand that?
13 THE DEFENDANT: I do, your Honor.
14 THE COURT: If you can't afford counsel for the
15 appeal, the Court will appoint one for you free of charge. Do
16 you understand that?
17 THE DEFENDANT: Yes.
18 THE COURT: All right. Very good.
19 (Adjourned)
20
21
22
23
24
25
SOUTHERN DISTRICT REPORTERS, P.C.
(212) 805-0300
C.Agnello SE 0163
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 167 of 569 PageID #:
361
EXHIBIT I
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0164
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 168 of 569 PageID #:
Browse all sections 362
Banking
Bankruptcy
Class Action
Competition
Employment
Energy
Expert Analysis
Insurance
Intellectual Property
Product Liability
Securities
Beta Tools
Track docs
Track attorneys
Track judges
Site Menu
Join the Law360 team
Search legal jobs
Learn more about Law360
Read testimonials
Contact Law360
Sign up for our newsletters
Law360 Company
About Law360 Authority
Resource Library
Site Map
Help
Intellectual Property Securities Bankruptcy Competition Employment White Collar Legal Industry Artificial
Intelligence Law360 UK Pulse || See all sections || TAKE A FREE TRIAL
How satisfied are you with your job?
Click here to take the Law360 survey
Expert Analysis - Opinion
Cannabis Fraud Decision Shows Need For
Sentencing Reform
We use cookies that are necessary to make our site work. We may also use additional
cookies to analyze, improve, and personalize our content and your digital experience.
By Lloyd Liu and Hilary LoCicero · Listen to article
You can manage your cookie preferences using the Cookie Settings link and opt out
of personalized advertising via Ad Choices. For more information, see our Cookie
Law360
Policy.(October 5, 2021, 3:42 PM EDT) -- White collar lawyers around the country
closely monitored the recent case of U.S. v. Akhavan in the U.S. District Court for the
Southern District of New York, for several reasons, not the least of which was the
cutting-edge subject matter in the growing area of cannabis law.
C.Agnello SE 0165
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 169 of 569 PageID #:
363
The prosecutors' novel theory of the case — that the defendant was criminally
responsible for convincing banks to unwittingly process cannabis-related transactions —
colored the case from start to finish.
During the sentencing phase in August, U.S. District Judge Jed Rakoff of the Southern
District of New York refused to treat the entire $156 million in transactions facilitated by
the defendant as the relevant loss.
This decision is notable because it highlights from a unique angle the way that U.S.
Lloyd Liu
sentencing laws place an outsized emphasis on financial elements of criminal activity
even when they have a tenuous relationship with a defendant's criminal intent.
Hamid "Ray" Akhavan was convicted in March 2021 on one count of conspiracy to
commit bank fraud. Akhavan was charged with deceiving banks so that they would
process $156 million or so in payments to marijuana retailers, despite the fact that the
banks had internal compliance policies that forbade such services. There was no
allegation that Akhavan had obtained any of the processed funds himself; he was simply
a middleman.
In advance of sentencing, the parties extensively briefed the issue of loss under U.S.
Sentencing Guidelines Section 2B1.1, which was complicated by the fact that no party Hilary LoCicero
had actually lost any money as a result of the transactions. Because of that unusual posture, Judge Rakoff
directed the parties to provide briefing on the impact of Section 2B1.1, Note 3(b), which provides that "[t]he
court shall use the gain that resulted from the offense as an alternative measure of loss only if there is a loss but
it reasonably cannot be determined."[1]
The government argued that the entire $156 million the banks had been "tricked into releasing" was a reasonably
determinable loss amount and should be used in the guidelines calculation, and thus, that it was not necessary to
calculate the defendant's gain.[2] The government adopted a fallback position that, because Akhavan had gained
at least $17 million in processing fees through the criminal scheme, that figure also could be deemed the loss
amount.[3]
Counsel for Akhavan urged the court to conclude that, because there was no loss whatsoever, Comment 3(b) to
Section 2B1.1, which directed the court to consider gain only if there is a loss was not applicable.[4]
Ultimately, Judge Rakoff imposed a sentence of 30 months incarceration, after finding that there was, in fact, no
loss that had resulted from Akhavan's conduct. At sentencing, Judge Rakoff observed, "It appears to me that
there's never been a case where the guidelines were more irrational, silly and ridiculous than in this case."[5]
The government's arguments about how the loss amount should be calculated under Section 2B1.1 nevertheless
carried over to its position on forfeiture. The government sought the entire $156 million in forfeiture or,
alternatively, the $17 million in fees that Akhavan had received. Akhavan argued that forfeiture could not be
ordered because he had not obtained any of the money in question, as is required under the forfeiture laws, and
that a forfeiture order would violate the Eighth Amendment's prohibition against excessive fines.[6]
WeRakoff
Judge use cookies that are
found thatnecessary to make oursufficiently
the government site work. Weestablished
may also use additional
that Akhavan had obtained $17 million for
purposes of forfeiture under Title 18 of the U.S. Code,your
cookies to analyze, improve, and personalize our content and Section
digital982(a)(2).[7]
experience. He concluded, however, that a
forfeiture
You canof $17 your
manage million would
cookie constitute
preferences using an excessive
the Cookie fine in
Settings violation
link and opt outof the Eighth Amendment and reduced
the of
amount to advertising
approximately
personalized $100,000.
via Ad Choices. For more information, see our Cookie
Policy.
Relying on the U.S. Supreme Court's 1998 decision in U.S. v. Bajakajian, Judge Rakoff concluded that a fine of
$17 million would be "grossly disproportional to the gravity of [Akhavan's] offense." The court explained its
reasoning as follows:
C.Agnello SE 0166
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 170 of 569 PageID #:
364
As laid out above, there was no articulable loss to any party as a result of Akhavan's crime and a $17
million forfeiture order is seventeen times the maximum fine and 170 times the actual fine imposed in this
case.[8]
This outcome makes sense both practically and equitably. It would be difficult to reconcile a conclusion that
Akhavan's term of incarceration should be determined based on a loss amount far less than the $17 million, and
yet he should be subject to forfeiture in that amount.
Judge Rakoff's analysis may be useful precedent for defense counsel in future white collar prosecutions, even
after accounting for the unique facts of Akhavan's case.[9] Loss amounts play, by far, the largest part in
calculating recommended sentences in federal criminal cases involving fraud and property crimes.
While most white collar criminal cases involve some loss as a result of the criminal conduct, there is an
important subset of cases that result in defendants being held accountable for loss amounts greatly
disproportionate to their culpability. Cases in which defendants are charged and convicted of criminal conspiracy
despite playing a minor role in the events at issue, are commonplace and not far removed from the facts of
Akhavan.
These cases have been a deep source of frustration for defense lawyers who represent lesser offenders in
conspiracy cases yet must defend against the possibility of an enormous loss amount.[10] Judge Rakoff's
decision begs the question: If a sentence in Akhavan based on a $17 million loss amount was so untethered to the
defendant's conduct as to be unsupportable — and unconstitutional, as concerns forfeiture — is it not equally
unfair to adopt such an expansive view in conspiracy cases?
Section 2B1.1 of the Sentencing Guidelines has been the subject of debate — and derision — for decades, for
this reason and others. As Barry Boss and Kara Kapp note in "How the Economic Loss Guideline Lost its Way,
and How to Save It"[11]:
The current loss table is ... a poor proxy for relative culpability in many cases. For example, the loss
calculation fails to account for the extent to which the offender personally profited from the offense.
Indeed, each offender is responsible for the total reasonably foreseeable loss attributable to all co-
defendants, regardless of how much each offender personally profited from that amount.[12]
The facts of Akhavan illustrate this conundrum.
There already has been significant judicial pushback against the unjustified impact of Section 2B1.1. Courts
depart or vary below the guidelines in the majority of cases to which Section 2B1.1 applies.[13]
However, the government and presentence report writers still adhere closely to Section 2B1.1, as was the case in
Akhavan. And, troublingly, the pushback is not consistent throughout the U.S. While Boss and Kapp note that
from 2015 through 2019, "more than 50 percent of sentences issued to fraud offenders were below the guideline
range," a significant percentage of sentences were not, and as Boss and Kapp further note, the guidelines
nevertheless have a "significant anchoring effect."[14]
Defendants who are similarly situated but convicted in different judicial districts thus can receive markedly
We use cookies
different sentencesthat—
area result
necessarythat
to is
make our site work.
anathema We may
to the also use
purpose additional
of the guidelines.
cookies to analyze, improve, and personalize our content and your digital experience.
BossYou
andcanKapp
managehave
youracookie
modest proposal
preferences thatthemight
using Cookiehave alleviated
Settings link and aopt
lotoutof the controversy in Akhavan: to narrow
the of
concept of loss
personalized under via
advertisingSection 2B1.1 to
Ad Choices. Foramore
consideration
information, of actual
see our loss. This starting point would provide a
Cookie
better sense of the defendant's relative culpability, a focus that is becoming increasingly necessary as the U.S.
Policy.
Department of Justice continues to seek indictments under increasingly tangential theories of culpability.
This would not, of course, restrict a court from considering intended loss altogether, given that the guidelines are
C.Agnello SE 0167
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 171 of 569 PageID #:
365 loss is completely irrelevant to sentencing in all cases.
purely permissive. And none of this is to say that intended
It has a place where, for example, scheme is thwarted before it has a chance to succeed, though even that line of
analysis is fraught.
But the central question that policymakers in the U.S. should be contemplating is how these factors should weigh
upon a sentencing judge's mind and influence the outcome of his or her decision. Despite the undoubtedly
excellent judgment of jurists like Judge Rakoff, who have seen firsthand, and vowed to combat,
overcriminalization in this country,[15] the guidelines remain the predominant anchor point to sentencing.[16]
Akhavan exemplifies the Section 2B1.1 loss amounts mentality that reverberates beyond crafting a sentence. No
guidance can be perfect, and there is always bound to be fuzziness at the edges. However, Akhavan is only just
another of a legion of cases that show the too-often untethered results that stem from the Section 2B1.1
framework. The time for reform is now.
Lloyd Liu is a partner and Hilary Holt LoCicero is a founding partner at Bennett LoCicero & Liu LLP.
The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients
or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information
purposes and is not intended to be and should not be taken as legal advice.
[1] U.S. v. Akhavan, 20-CR-188 (JSR) (S.D.N.Y. August 2021). Docket Entry No. 315 at 1.
[2] DE 318 at 5.
[3] Id. at 3-4.
[4] DE 317 at 4.
[5] Stewart Bishop, "Businessmen Get Prison For Cannabis Bank Processing Con," Law360, June 18, 2021,
https://www.law360.com/articles/1395688/businessmen-get-prison-for-cannabis-bank-processing-con.
[6] DE 317 at 13.
[7] DE 352 at 11-13.
[8] Id. at 19.
[9] Judge Rakoff has been outspoken about his concerns with respect to current sentencing framework. See Why
The Innocent Plead Guilty and the Guilty Go Free, at 23 ("[T[he guidelines, like the mandatory minimums,
provide prosecutors with weapons to bludgeon defendants into effectively coerced plea bargains.").
[10] David Debold and Matthew Benjamin provide an illustrative example in "'Losing Ground' – In Search of a
Remedy for the Overemphasis on Loss and Other Culpability Factors in the Sentencing Guidelines for Fraud and
Theft," 160 U. Penn. Law Rev. PENNumbra 141, 152-53.
We use cookies that are necessary to make our site work. We may also use additional
Takecookies
an accountant at a public
to analyze, improve, and company
personalize who is deliberately
our content ignorant
and your digital of a subordinate's improper bookkeeping.
experience.
Assume that
You can this your
manage defendant
cookie turns a blind
preferences eye
using because he
the Cookie is link
Settingsafraidandthe company might miss its earnings target, and
opt out
he isofunder great advertising
personalized pressure via
notAd
to let that For
Choices. happen
more in light of the
information, negative
see our Cookiereaction the year before when his honest
reporting
Policy. of a bookkeeping mistake caused the company to fall short. With a public company that issues millions
of shares, even small inflation in the price of a stock can add up to tens of millions of dollars in loss. Even if this
defendant never sold any stock, and therefore never realized a penny of gain from the fraud, the guidelines
would treat him the same as a career con man who creates a phony company, runs it as a Ponzi scheme, pockets
C.Agnello SE 0168
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 172 of 569 PageID #:
366the country. Motive, intent, and personal gain are all
tens of millions in proceeds for his own benefit, and flees
important offense characteristics that do not get accounted for in the guidelines.
[11] Barry Boss and Kara Kapp, "How the Economic Loss Guideline Lost its Way, and How to Save It," 18 Ohio
St. J. Crim. L. 605 (Spring 2021).
[12] How the Economic Loss Guideline Lost its Way at 617.
[13] Id. at 621, n. 75.
[14] Id. at 621-2.
[15] More broadly, when discussing the overall phenomenon of our criminal justice system, Judge Rakoff
himself has suggested that, "If there were the political will to do so, we could eliminate mandatory minimums,
eliminate sentencing guidelines, and dramatically reduce the severity of our sentencing regimes in general." Why
The Innocent Plead Guilty and the Guilty Go Free, at 30.
[16] See "Why the Innocent Plead Guilty and the Guilty Go Free" at 24 ("But what really puts the prosecutor in
the driver's seat is the fact that the prosecutor – because of mandatory minimums, sentencing guidelines, and
simply his ability to shape whatever charges are brought – can effectively dictate the sentence by how he drafts
the indictment. [ . . . ]. [I]t is the prosecutor, not the judge, who effectively exercises the sentencing power, albeit
cloaked as a charging decision.").
For a reprint of this article, please contact reprints@law360.com.
More Expert Analysis
Submit A Rebuttal
Attached Documents
Opinion
Useful Tools & Links
Add to Briefcase
Save to PDF & Print
Rights/Reprints
Editorial Contacts
Related Sections
Banking
California
Cannabis
We use cookies that are necessary to make our site work. We may also use additional
Criminal Practice
cookies
NewtoYork
analyze, improve, and personalize our content and your digital experience.
YouRetail
can manage your cookie preferences using the Cookie Settings link and opt out
& E-Commerce
of Trials
personalized advertising via Ad Choices. For more information, see our Cookie
White Collar
Policy.
Law Firms
C.Agnello SE 0169
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 173 of 569 PageID #:
367
EXHIBIT J
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0170
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 174 of 569 PageID #:
368
As a library, NLM provides access to scientific literature. Inclusion in an NLM database does
not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of
Health.
Learn more: PMC Disclaimer | PMC Copyright Notice
Clin J Am Soc Nephrol. 2019 Mar 11;14(4):597–608. doi: 10.2215/CJN.11220918
Risks of Living Kidney Donation
Current State of Knowledge on Outcomes Important to Donors
Krista L Lentine 1,2,✉, Ngan N Lam 3, Dorry L Segev 4,5,✉
Author information Article notes Copyright and License information
PMCID: PMC6450354 PMID: 30858158
See commentary "Commentary on Risks of Living Kidney Donation" on page 609.
Abstract
In the past decade, there have been increasing efforts to better define and quantify the short- and
long-term risks of living kidney donation. Recent studies have expanded upon the previous
literature by focusing on outcomes that are important to potential and previous donors, applying
unique databases and/or registries to follow large cohorts of donors for longer periods of time, and
comparing outcomes with healthy nondonor controls to estimate attributable risks of donation.
Leading outcomes important to living kidney donors include kidney health, surgical risks, and
psychosocial effects of donation. Recent data support that living donors may experience a small
increased risk of severe CKD and ESKD compared with healthy nondonors. For most donors, the
15-year risk of kidney failure is <1%, but for certain populations, such as young, black men, this
risk may be higher. New risk prediction tools that combine the effects of demographic and health
factors, and innovations in genetic risk markers are improving kidney risk stratification. Minor
C.Agnello SE 0171
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 175 of 569 PageID #:
369
perioperative complications occur in 10%–20% of donor nephrectomy cases, but major
complications occur in <3%, and the risk of perioperative death is <0.03%. Generally, living kidney
donors have similar or improved psychosocial outcomes, such as quality of life, after donation
compared with before donation and compared with nondonors. Although the donation process
should be financially neutral, living kidney donors may experience out-of-pocket expenses and lost
wages that may or may not be completely covered through regional or national reimbursement
programs, and may face difficulties arranging subsequent life and health insurance. Living kidney
donors should be fully informed of the perioperative and long-term risks before making their
decision to donate. Follow-up care allows for preventative care measures to mitigate risk and
ongoing surveillance and reporting of donor outcomes to inform prior and future living kidney
donors.
Keywords: Living donation; outcomes; Patient-centered care; Living Donors; Health Expenditures;
Aftercare; quality of life; Kidney Failure, Chronic; kidney; Renal Insufficiency, Chronic; Insurance;
Health; Registries; Nephrectomy; Salaries and Fringe Benefits
Introduction
Since the inception of the successful practice of living donor kidney transplantation in 1954,
>150,000 living persons in the United States have donated a kidney to help a family member, a
friend, or even a stranger (1). Worldwide, >35,000 living donor kidney transplants are performed
each year (2). Living donors derive no medical benefit from donation, nor do they expect to, but
living donors do deserve transparent information on the short- and long-term outcomes of
donation to support informed decision-making, follow-up, and care (3). The risks of living donation
are accepted as sufficiently low to justify the practice, but notably, much of the available evidence
has been limited by short observation periods, a high proportion of donors lost to follow-up,
insufficient power to quantify rare events, and limited racial diversity (4–6). Furthermore, until
recently, most studies compared donors with the unscreened general population. Recognition of
these deficiencies, and the vital need to address them, prompted a growing body of research over
the past decade that has helped advance understanding of donor risks (7). The study
methodologies include construction of multicenter cohorts (8,9), integration of national donor
registries with other data sources to acquire longer-term information for a broader spectrum of
outcomes (10–19), and assembly of healthy nondonor controls for estimation of donation-
attributable risks (20–25). The resulting evidence suggests small donation-related increases in the
risk of kidney failure that have affected policy requirements and guidelines for the informed
consent and care of living donors (26,27). Efforts to establish larger living donor consortia and
registries with long-term follow-up are also being planned and pilot-tested (28,29).
C.Agnello SE 0172
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 176 of 569 PageID #:
370
The recent 2017 Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline on
the Evaluation and Care of Living Kidney Donors focuses on risk assessment as a foundational theme. A
central framework of the guideline is promotion of “consistent, transparent and defensible
decision-making” on the basis of comparisons of individualized, quantitative estimates of donor
risks “to a transplant program’s acceptable risk threshold” (Figure 1) (27). Although robust data
necessary to ground risk thresholds for many outcomes are lacking, this conceptual framework
provides a new structure for the consideration of available data by patients and providers, and a
roadmap for design of future studies to address evidence gaps. Kidney donation is a decision with
lifelong implications that can span dimensions of medical and psychosocial health. A new study
found that “living kidney donors prioritized a range of outcomes, with the most important being
kidney health and the surgical, lifestyle, functional, and psychosocial effects of donation” (30). In
this review, we summarize the current state of evidence related to these outcomes important to
donors, and suggest next steps to advance the evidence base for donor risk estimation and
application with a transparent, consistent framework of shared decision-making.
C.Agnello SE 0173
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 177 of 569 PageID #:
371
Figure 1.
🔍
Open in a new tab
The KDIGO framework to accept or decline donor candidates compares projected
lifetime risk of kidney (quantified as the aggregate of risk related to demographic
and health profile and donation-attributable risks) to a transplant program's
threshold of acceptable risk. Reproduced from reference 27, with permission.
Kidney Health
Assessment of living kidney donor values and perceptions at three centers in Australia and Canada
by Hanson et al. (30) identified kidney function as the highest ranked outcome important to living
donors, underpinned by fear of developing kidney failure. Although many donors felt they had
ruled out the risk of kidney failure during evaluation, some were uncertain whether their
glomerular filtration rate (GFR) after donation was “normal” and how to protect their long-term
C.Agnello SE 0174
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 178 of 569 PageID #:
372
kidney function (e.g., by lifestyle or dietary modifications) (30). Similarly, a new study of 193 living
kidney donors in the United States, assessed at 1, 6, 12, and 24 months postdonation, found that
21% (n=32) reported an emergence of anxiety about kidney injury or loss at one or more
postdonation assessments, but this anxiety dissipated in 35% (11 out of 32) (31). In an interview-
based study of 50 living donors at one center (assessed at a median 9 years after donation), 22%
reported concern for failure of the remaining kidney before donation, whereas 12% endorsed this
concern postdonation (32).
After donor nephrectomy there is compensatory hyperfiltration in the remaining kidney, such that
the net reduction in GFR early after donation is only approximately 30% (25%–40%; i.e.,
decrement in GFR of 25–40 ml/min per 1.73 m2) (33–36). One long-term study of glomerular
hemodynamics after kidney donation observed that the adaptive hyperfiltration mostly resulted
from compensatory glomerular hypertrophy and hyperperfusion in the remaining kidney, rather
than pathologic glomerular hypertension (37). In a prospective study of 182 predominantly
(94.6%) white kidney donors and paired healthy nondonors, GFR measured by iohexol clearance
declined 0.36 ml/min per year in nondonor controls but increased 1.47 ml/min per year in donors
between 6 and 36 months of follow-up (33,35). The trajectory of change in GFR beyond 36 months
postdonation, and associations with risk for ESKD, requires examination in larger, demographically
diverse samples. A recent study of 2002 predominantly white living donors followed for up to 20
years at one center did not support an association of postdonation estimated glomerular filtration
rate (eGFR) trajectory and ESKD risk (38). Nevertheless, there is concern that adaptive
hyperfiltration might result in faster progression of de novo kidney disease that could accelerate
deterioration to low levels of kidney function or kidney failure (39).
Clinically important kidney end points include progression to advanced stages of CKD, injury
markers such as proteinuria, and most importantly, ESKD. One study of 3956 predominantly white
kidney donors found that 36% had eGFR<60 ml/min per 1.73 m2 (corresponding to CKD stage 3 or
higher) at a median time of 9.2 years postdonation, and 2.6% had eGFR<30 ml/min per 1.73 m2
(corresponding to CKD stage 4 or higher) at a median of 23.9 years (40). Postdonation proteinuria
was higher in men (adjusted hazard ratio [aHR], 1.56; 95% confidence interval [95% CI], 1.18 to
2.05; P<0.001) and those with higher body mass index (BMI) (aHR, 1.10 per unit; P<0.001) (40). A
meta-analysis found that after an average of 10 years of follow-up, 12% of donors had a GFR in the
30–59 ml/min range whereas only 0.2% had a GFR in the <30 ml/min range; further, most donors
did not have a progressive GFR loss after the initial reduction postdonation (36). As in the general
population, risk of kidney complications varies by baseline donor traits, such as race. For example,
a study of 4650 donors in the United States found that by 7 years postdonation, after adjustment
for age and sex, a greater proportion of black donors compared with white donors had kidney-
C.Agnello SE 0175
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 179 of 569 PageID #:
373
related diagnoses: CKD (12.6% versus 5.6%; aHR, 2.32), proteinuria (5.7% versus 2.6%; aHR, 2.27;
95% CI, 1.48 to 3.62), and nephrotic syndrome (1.3% versus 0.1%; aHR, 15.7; 95% CI, 2.97 to 83.0)
(17).
Although the risk of ESKD after kidney donation does not exceed ESKD rates in the general
population (41–43), two recent studies comparing donors with healthy nondonors for estimation
of donation-attributable risk found that donation is associated with a small but significant
increase in the risk of ESKD. In comparing 1901 kidney donors with 32,621 healthy,
demographically matched controls in Norway, Mjøen et al. (22) found that nine donors (0.47%)
developed ESKD versus 22 healthy nondonors (0.07%) (aHR, 11.9; 95% confidence interval [95%
CI], 4.4 to 29.6). On the basis of linking data for 96,217 living donors from the United States donor
registry and healthy participants drawn from National Health and Nutrition Examination Survey
III to national ESKD reporting forms, Muzaale et al. (21) reported that the cumulative incidence of
ESKD at 15 years was 30.8 per 10,000 in donors compared with 3.9 per 10,000 in matched donors
(risk attributable to donation of 26.9 per 10,000). Considered by race, black living donors had the
highest absolute risk of ESKD postdonation as well as the highest risk attributable to donation.
Although the risk increase is small, details have been debated (44), and absolute postdonation risk
is low overall, these data have appropriately shaped informed consent policies in the interest of
transparent disclosure, such that United States transplant programs are now required to disclose
the possibility of donation-attributable increase in ESKD risk (26), and similar disclosure is
recommended for international practice by the 2017 KDIGO guideline (27).
Some information is available on ESKD causes after donation. A linkage of national donor registry
data to ESKD registry data for 125,427 living donors found that early postdonation ESKD was
predominantly reported as due to glomerulnephritis (GN), whereas late postdonation ESKD was
more frequently reported as due to diabetes or hypertensive kidney disease, the latter two
consistent with the leading causes of ESKD in the United States general population (45). In a
single-center study of 3956 predominantly white living donors, 48% of ESKD events with known
causes (n=12 out of 25) were related to hypertension or diabetes (46). Although the pathways from
predonation metabolic and genetic risk factors to postdonation ESKD are not yet well defined,
these data emphasize the importance of careful evaluation to identify kidney risk factors,
counseling regarding known and unknown risks, and engagement in postdonation follow-up,
especially for higher-risk groups, so that any signs of early postdonation kidney problems can be
recognized and managed.
To help ground a quantitative framework for living donor candidate evaluation, the 2017 KDIGO
guideline development methodology included collaboration with the CKD Prognosis Consortium
C.Agnello SE 0176
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 180 of 569 PageID #:
374
to develop a tool to project the 15-year and lifetime incidence of kidney failure in the absence of
donation on the basis of demographic and health characteristics at the time of evaluation (47). The
risk model uses meta-analysis of data from nearly 5,000,000 healthy persons identified from seven
general population cohorts who are similar to kidney donor candidates, calibrated to annual ESKD
incidence in the United States healthy population (47), and the resulting online tool is available
online (www.transplantmodels.com ). Projected ESKD risk was higher in the presence of a lower
estimated GFR, higher albuminuria, hypertension, current or former smoking history, diabetes
mellitus, and obesity. In the model-based lifetime projections, the risk of ESKD in the absence of
donation was highest among persons in the youngest age group, particularly among young black
men. Importantly, a central principle of the approach and tool is risk assessment on the basis of
simultaneous consideration of a profile of demographic and clinical characteristics, rather than
individual factors in isolation (e.g., risk related to high BP or BMI alone), and comparison of
integrated risk to a threshold of acceptable risk (Figure 1).
Other tools are available. Using a cohort of 3956 white donors, Ibrahim et al. (40) developed a
calculator for eGFR<30 ml/min per 1.73 m2 or ESKD on the basis of risk relationships for older
age (hazard ratio [HR], 1.07; 95% CI, 1.05 to 1.09 P<0.001), higher BMI (HR, 1.08; 95% CI, 1.04 to
1.13; P<0.001), and higher systolic BP (HR, 1.02; 95% CI, 1.00 to 1.04; P=0.01). Another recent tool
estimates postdonation risk on the basis of national United States registry and ESKD data for
133,824 living donors. ESKD risk after donation in this model is higher with male sex, black race,
higher BMI, and biologic relationship to recipient (48). Because of the lack of available data, the
model does not incorporate clinical or laboratory variables, such as the use of antihypertensive
medications and urine albumin excretion. A key finding in this study was that although the 20-year
predicted ESKD risk was very small in the average (median) donor (34 in 10,000), in a small
subgroup of donors (1%) the risk was substantially higher than the median (256 in 10,000) (48).
Recent studies of kidney outcomes in living donors, including ESKD, reduced GFR/CKD, and
proteinuria, are summarized in Table 1.
C.Agnello SE 0177
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 181 of 569 PageID #:
375
Table 1.
Summary of recent studies of kidney outcomes in living donors, according to risk
perspective
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
ESKD
Gibney et al. • Linkage of • Transplant waitlist • Descriptive • 102 LKD
(87) OPTN LKD registrations among waitlisted at
Transplantation registration prior LKD as a median 17.6 yr
2007 (1993–2005) and measure of ESKD postdonation
transplant • Between • Among listed
waitlist donors LKD, 44% were
registration data black (compared
(1993–2005) for with 14% total
8889 United black donors;
States LKD P<0.0001) and
40% were white
(compared with
14% total black
donors;
P<0.0001)
Ibrahim et al. • Cohort study of • ESKD requiring • LKD versus • 11 LKD
(41) N Engl J 3698 LKD at one dialysis or general developed ESKD,
Med 2009 center in transplantation on population at an average of
Minnesota, the basis of the 22.5±10.4 yr
United States report of the LKD or (180 cases
(1963–2007); recipient PMPY)
98% white race • ESKD in LKD
did not exceed
national ESRD
rate for white
C.Agnello SE 0178
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 182 of 569 PageID #:
376
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
Americans (268
cases PMPY)
Cherikh et al. • Linkage of • ESKD defined by • LKD versus • ESKD was
(88) Am J OPTN LKD CMS Medical general significantly
Transplant 2011 registration Evidence Form 2728 population higher in black
(1987–2003) and compared with
national kidney white LKD:
replacement 0.423 versus
treatment (1987– 0.086 per 1000
2009) for 56,458 yr at risk (RR,
United States LKD 4.92; P<0.05).
• Mean follow-up 9.8 • ESKD in LKD
yr did not exceed
national reports
for general
United States
population, by
race (0.998 and
0.273 per 1000
for black and
white
Americans,
respectively)
Mjøen et al. • Linkage of • ESKD reported in • LKD versus • ESKD was
(22) Kidney Int transplant the national registry healthy higher among
2014 registry data for nondonors LKD compared
1901 Norwegian with healthy
LKD with national nondonors (302
kidney versus 100
replacement PMPY; aHR,
treatment records 11.38; P<0.001)
• Healthy controls • Median and
from HUNT-1 maximum donor
survey (1984–
C.Agnello SE 0179
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 183 of 569 PageID #:
377
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
1987) after follow-up: 15.2 and
screening for 44 yr, respectively
health exclusions
to donation, then
matched by
demographic and
clinical factors
• Median and
maximum control
follow-up: 25 and 26
yr, respectively
Muzaale et al. • Linkage of • ESKD reported in • LKD versus • ESKD was
(21) JAMA 2014 OPTN LKD national registries healthy higher among
registration (initiation of nondonors LKD compared
(1994–2011) and maintenance dialysis, with healthy
national kidney waitlist placement, or nondonors (3.9
replacement transplant) versus 30.8 per
treatment records 10,000 over 15
for 96,217 United yr; P<0.001)
States LKD
• “Healthy” • Median and • Black LKD had
controls drawn maximum LKD highest
from NHANES III, follow-up, 7.6 and 15 cumulative
after screening for yr, respectively incidence of
health exclusions ESKD and
to donation, then highest absolute
matched by risk increase
demographic and (donation-
clinical factors attributable
increase per
10,000 over 15
yr by race: 50.8
in black, 25.9 in
Hispanic, and
C.Agnello SE 0180
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 184 of 569 PageID #:
378
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
22.9 in white
LKD)
• Median and
maximum control
follow-up: 15 yr
Ibrahim et al. • Cohort study of • Composite of ESKD • Between • Cumulative
(40) J Am Soc 3956 white LKD (on the basis of donors incidence of
Nephrol 2016 at one center in report of the LKD or ESKD per 10,000
Minnesota, recipient), or at 15, 30, and 40
United States eGFR<30 ml/min per yr was 13.5,
(1963–2013) 1.73 m2 68.7, and 78.7,
respectively
• Mean and • Composite end
maximum follow-up: point was
16.6 and 51 yr, associated with
respectively older age (aHR,
1.07 per yr;
P<0.001), higher
BMI (aHR, 1.08
per kg/m2;
P<0.01), and
higher systolic
BP (aHR, 1.02
per mm Hg;
P<0.01) at
baseline.
Locke et al. • Linkage of • ESKD reported in • Between • Cumulative
(89) Kidney Int OPTN LKD national registries, as donors incidence of
2016 registration per (21) ESKD at 20 yr
(1987–2013) and was 93.9 per
national kidney 10,000 in obese
replacement compared with
treatment records 39.7 per 10,000
in nonobese LKD
C.Agnello SE 0181
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 185 of 569 PageID #:
379
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
for 119,769 • Median and • Covariate-
United States LKD maximum follow-up: adjusted ESKD
10.7 and 20 yr, risk was 86%
respectively higher in
compared versus
nonobese LDK
(aHR, 1.86;
P=0.04)
• Each 1-unit
increase in
BMI>27 kg/m2
was associated
with 7% higher
ESKD risk (aHR,
1.07; P=0.004)
Anjum et al. • Linkage of • ESKD reported in • Between • Cumulative
(45) Am J OPTN LKD national registries, as donors incidence of
Transplant 2016 registration per (21) ESKD increased
(1987–2014) and from 10 per
national kidney 10,000 at 10 yr
replacement to 85 per 10,000
treatment records at 25 yr
for 125,427 • ESKD causes from • Early (within
United States LKD CMS Medical 10 yr)
Evidence Form 2728, postdonation
categorized as ESKD was
hypertension/large predominantly
vessel disease, attributed to GN,
diabetes, or GN whereas later
predominantly
reported as
diabetic and
hypertensive
(later versus
C.Agnello SE 0182
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 186 of 569 PageID #:
380
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
early IRR, 7.7
and 2.6,
respectively)
• Median and • Time-
maximum follow-up: dependent
11 and 25 yr, increase did not
respectively occur for GN
(IRR, 0.7)
Massie et al. • Linkage of • ESKD defined by the • Between • ESKD risk was
(48) J Am Soc OPTN LKD CMS Medical donors significantly
Nephrol 2017 registration Evidence Form 2728 (P<0.01) higher
(1987–2015) and with black race
national kidney (aHR, 2.96),
replacement male sex (aHR,
treatment records 1.88), higher
for 133,842 BMI (aHR, 1.61
United States LKD per 5 kg/m2),
and first-degree
relationship to
recipient (aHR,
1.70)
• Among
nonblack LKD,
ESKD risk
increased with
older age (aHR,
1.40 per decade)
• Among black
LKD, older age
was not
significantly
associated with
ESKD risk (HR,
0.88; P=0.3)
C.Agnello SE 0183
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 187 of 569 PageID #:
381
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
Matas et al. • Cohort study of • ESKD on the basis • Between • 39 developed
(46) Am J 4030 LKD at one of the report of the donors ESKD at mean of
Transplant 2018 center in LKD or recipient as in 27±9.8 yr
Minnesota, (41), or return to
United States center
(1963–2015) • Mean and • 48% of ESKD
maximum follow-up: events with
18.0 and 15 yr, known causes
respectively (n=12/25) were
attributed to
hypertension or
diabetes (alone
or in
combination)
Serrano et al. • Cohort study of • ESKD on the basis • Between • No difference
(90) Am J 3752 LKD at one of the report of the donors in ESKD at end of
Transplant 2018 center in LKD or recipient as in study in obese
Minnesota, (41), or return to and nonobese
United States center donors (0.5%
(1975–2014); • End of follow-up versus 0.6%;
98% white not reported P=0.46)
Wainright et • Linkage of • ESKD reported in • Between • 218 developed
al. (91) Am J OPTN LKD national registries, as donors ESKD, at a
Transplant 2018 registration per (21) median of 11 yr
(1994–2016) and • Median follow-up: • ESKD risk was
national kidney 10.3 yr significantly
replacement (P<0.01) higher
treatment records with male sex
for 123,526 (aHR, 1.75),
United States LKD higher BMI (aHR,
1.34 per 5
kg/m2), first-
degree
relationship to
C.Agnello SE 0184
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 188 of 569 PageID #:
382
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
recipient (aHR,
2.01), lower
predonation
eGFR (aHR, 0.89
per 10 ml/min
per 1.73 m2
increase), and
lower SES
neighborhood at
donation
• Among white
LKD, ESKD risk
increased with
older age (aHR,
1.26 per decade)
• Among black
LKD, ESKD risk
decreased with
older age (aHR,
0.75 per decade)
Reduced GFR/CKD, proteinuria, and other kidney
complications
Lentine et al. • Linkage of • CKD diagnosis over • Descriptive • Overall, CKD
(10) N Engl J OPTN data for median 7.7 yr follow- was reported in
Med 2010 4650 LKD in up 5.2% at 5 yr
1987–2007 with
administrative
billing claims
from a private
health insurer
(2000–2007
claims)
• Stage-specific • Between • Adjusted CKD
CKD coding donors risk was twice as
C.Agnello SE 0185
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 189 of 569 PageID #:
383
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
examined a likely among
subgroup of 2307 black (aHR, 2.32;
LKD P<0.001) or
Hispanic (aHR,
1.90; P<0.001)
compared with
white LKD
• CKD stage 3
was higher in
black (aHR, 3.60;
P=0.009) or
Hispanic (aHR,
4.2; P=0.006)
versus white
LKD
Lentine et al. • Linkage of • CKD and • Descriptive • At 5 yr, CKD
(15) OPTN data proteinuria was reported in
Transplantation (starting 1987) diagnoses 5.2% of the
2013 with privately insured
administrative and 21.8% of the
billing claims for Medicare-
4650 privately insured LKD, and
insured (2000– proteinuria in
2007 claims) and 2% and 5%,
4007 Medicare- respectively
insured (2000– • Median follow-up • Between • Adjusted CKD
2008 claims) LKD 7.7 yr for the donors risk was higher
privately insured and for black LKD in
6 yr for the Medicare- the privately
insured samples insured (aHR,
2.32; P<0.001)
and Medicare
(aHR, 1.84;
C.Agnello SE 0186
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 190 of 569 PageID #:
384
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
P<0.001)
samples
• Adjusted
proteinuria risk
was higher for
black LKD in
privately insured
(aHR, 2.27;
P<0.05) and
Medicare (aHR,
2.44; P<0.001)
samples
Lentine et al. • Linkage of • CKD diagnosis over • Descriptive • At 7 yr,
(17) OPTN data for median 7.7 yr follow- significantly
Transplantation 4650 LKD with up more (P<0.05)
2015 private insurance black compared
medical claims, as with white LKD
above (10) had kidney
condition
diagnoses: CKD
• Between (12.6% versus
donors 5.6%; aHR,
2.32),
proteinuria
(5.7% versus
2.6%; aHR,
2.27), nephrotic
syndrome, (1.3%
versus 0.1%;
aHR, 15.7), and
any kidney
condition
(14.9% versus
9.0%; aHR, 1.72)
C.Agnello SE 0187
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 191 of 569 PageID #:
385
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
Kasiske et al. • Prospective • GFR measured by • LKD versus • GFR declined
(35) Am J Kidney study of 182 LKD plasma iohexol healthy 0.36±7.55
Dis 2015 (94.6% white) clearance, from 6 to nondonors ml/min per yr in
30 mo postdonation controls but
increased
1.47±5.02
ml/min per yr in
LKD (P for
difference in
change =0.005)
• Paired controls • Proteinuria and • Albuminuria
meeting donor albuminuria increased
selection criteria modestly in LKD
(3.6–4.2 mg/g)
but not in
controls (4.7–4.7
mg/g) (P for
difference in
change <0.001)
• Proteinuria did
not increase in
LKD or controls
Ibrahim et al. • Cohort study of • Urinary AER >30 • Between • Proteinuria
(40) J Am Soc 3956 white LKD mg/g donors was identified in
Nephrol 2016 at one center in 6.1% at median
Minnesota, 18 yr
United States Creatinine, 24-h • Proteinuria
(1963–2013) urinary protein >200 was associated
mg/d, ≥2+on urine with higher BMI
dipstick tests, self- (aHR, 1.10 per
report kg/m2; P<0.001)
and male sex
(aHR, 1.56;
P<0.01), and less
C.Agnello SE 0188
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 192 of 569 PageID #:
386
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
common in
donors related
to their recipient
(aHR, 0.58;
P=0.03)
• Mean and
maximum follow-up:
16.6 and 51 yr,
respectively
Matas et al. • Cohort study of • eGFR by CKD • Between • Average eGFR
(38) Am J 2002 white LKD Epidemiology donors increased
Transplant 2018 at one center in Collaboration steadily until
Minnesota, equation donors reached
United States age 70 yr: 1.12
(1990–2014) ml/min per 1.73
m2 per yr
between 6 wk
and 5 yr
postdonation,
0.24 ml/min per
1.73 m2 per yr
between 5 and
10 yr
postdonation,
and 0.07 ml/min
per 1.73 m2 per
yr between 10
and 20 yr
postdonation
• Donors contacted at • After age 70,
6, 12, 24, and 36 mo, eGFR declined
then every 3 yr
• Includes request to • eGFR
contact local clinics trajectories did
C.Agnello SE 0189
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 193 of 569 PageID #:
387
Author, yr Data Outcome Measure Risk Findings
Source/Design and Follow-Up Perspective
for laboratory tests not explain ESKD
risk
Open in a new tab
Adapted and updated from reference 7, with permission. OPTN, Organ Procurement and
Transplantation Network; LKD, living kidney donors; PMPY, per million per year; CMS,
Centers for Medicare & Medicaid Services; RR, relative risk; HUNT-1, Nord-Trøndelag Health
Study; aHR, adjusted hazard ratio; NHANES, National Health and Nutrition Examination
Survey; GN, glomerulonephritis; BMI, body mass index; IRR, incidence rate ratio; HR,
hazard ratio; SES, socioeconomic status; AER, albumin excretion rate.
Surgical Risks
In the study by Hanson et al. (30), avoiding catastrophic consequences such as surgical mortality
and morbidity was important to donors, particularly during decision-making, because they were
the “most serious” outcomes and would also affect their family. Some participants ranked time to
recovery, surgical complications, and pain highly because they felt “deeply disappointed” and
“resentful” about enduring a more debilitating and protracted recovery than they had been “led to
expect.” (30) In a multicenter, prospective study of 228 living donors, perioperative complications,
not surprisingly, were associated with clinically and statically significant reductions in measures
of health-related quality of life (49). Other studies have noted that a minority of donors have
reported slower than expected recovery (50). However, aside from capture of length of initial
hospital stay and time to return to work in some clinical trials (typically comparisons of different
operative techniques) (51,52) and single-center reports, data on postdonation recovery are not
systematically captured.
Fortunately, the risk of morbidity and mortality after living donor nephrectomy is low. A United
States study linking the national donor registry for 80,347 donors to the Social Security Death
Master Index reported the 90-day mortality to be 3.1 per 10,000 (20). Consistent rates have also
been reported in other studies (53). Administrative data have been used to identify perioperative
complications in large samples of living kidney donors, independent of center or surgeon
reporting. Using a composite outcome of cardiac, respiratory, digestive, urinary, procedural,
C.Agnello SE 0190
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 194 of 569 PageID #:
388
hemorrhage, or infectious complications, one United States study estimated the incidence of
perioperative complications as 7.9% and noted a decrease over time, from 10.1% in 1998 to 7.6%
in 2010 (54). Limitations of this study include the lack of confirmation of donor status through
patient-level linkages to the national registry, and use of weighting schemes to draw inferences for
a “represented” sample of all United States donors on the basis of a stratified sample of 20% of
acute care hospitalizations (55). A subsequent study integrated national United States donor
registry data as a source of verified living donor status with administrative records from a
consortium of 98 academic hospitals (2008–2012, n=14,964). In this study, 16.8% of donors
experienced any perioperative complication, most commonly gastrointestinal (4.4%), bleeding
(3.0%), respiratory (2.5%), and surgical/anesthesia-related injuries (2.4%) (18). Major
complications, defined as Clavien grading system for surgical complications level 4 or 5 (56),
affected 2.5% of donors. Similarly, a Norwegian registry-based study of 1022 living kidney
donations performed between 1997 and 2008 reported 18% minor and 2.9% major complications
by Clavien grading (57). The 2017 KDIGO guideline and the European Association of Urology
Guidelines on Renal Transplantation: Update 2018 present these estimates as information for donor
counseling (27,58). Given the low incidence of major perioperative complications, estimates for
predonation characteristics that alter the risk are imprecise. Efforts to capture granular
complications data, such as through large, national registries, including development and
validation of patient-centered recovery measures, are needed to support contemporary estimates
of the risk of perinephrectomy complications according to an individualized profile of predonation
characteristics (27).
Psychosocial Outcomes
Quality of Life
Although living donors derive no personal medical benefit from donation, they may experience
psychosocial benefits related to the altruistic act of improving the health and wellbeing of another
person. A systematic review assessing psychosocial health in living kidney donors found that the
majority of donors scored high on health-related quality-of-life measurements (59). Psychosocial
health was unchanged or improved after donation and overall, and was similar or better than the
general population. A minority of donors experienced negative psychosocial outcomes such as
depression, anxiety, stress, and lower-quality relationships. Reassuringly, most donors did not
regret their decision to donate and would undergo the process again, even in the rare
circumstances when the recipient experiences a poor outcome (9). However, recipient graft loss
and death have been associated with increased risk of depression treatment after donation in some
studies (12).
C.Agnello SE 0191
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 195 of 569 PageID #:
389
Recently, Rodrigue et al. (31) reported on psychosocial measures assessed pre- and postdonation
among 193 living kidney donors and 20 healthy controls. Donors experience minimal to no
dysfunction in mood, body image, fear of kidney failure, life satisfaction, and decisional stability up
to 2 years postdonation, and their outcomes did not differ significantly from the healthy nondonor
controls. The overall incidence of new-onset mood disturbance (16%), fear of kidney failure (21%),
body image concerns (13%), and life dissatisfaction (10%) after donation was low. Donors with
preexisting concerns were at the highest risk of the same outcomes postdonation. Thus, although
donors have generally favorable psychosocial outcomes postdonation, the small risk of adverse
psychosocial functioning should be discussed with all living kidney donor candidates.
Financial Risks
Although the study by Hanson et al. (30) found that some donors had financial assistance to help
them absorb out-of-pocket expenses and replace lost income as a result of donation, other
participants ranked financial concerns highly because they believed that lost income and out-of-
pocket expenses were unfair barriers to donors. For younger donors, single parents, and one donor
who was not a resident and uninsured, the costs were “a big hit” and, for one, “an absolute
destruction.” (30) The leave required for recovery caused some donors to lose their jobs (30). A
recent survey of 51 United States donors found that perceived financial burden was highest among
those with predonation cost concerns and with an income <$60,000 (60).
Although it is widely accepted that living donation should be a financially neutral act,
unfortunately, financial risks are a reality in current practice. Even in countries where the
donation-related medical expenses are paid by the recipient’s insurance or the health care system,
it has been documented that donor candidates may incur many types of direct and indirect costs in
the donation process, including for travel, medications, lost time from work, and dependent care
(61–63). In one United States study, 92% of living kidney donors incurred direct costs (median
$433, range $6–$10,240) and more than one third (36%) reported lost wages in the first year after
donation (median $2712, range $546–$19,728) (62). Similarly, a multicenter, Canadian cohort
found that 98% of living kidney donors incurred donation-related costs, with median (seventh
percentile) out-of-pocket costs of $1254 ($2598) (Canadian dollars); among 30% who experienced
unpaid time off work, median lost income was $5534, and total costs exceeded $5500 in 25% of
the cohort (64). A single-center, retrospective survey of living donors who were working for
compensation at the time of donation (2005–2015) found that increased length of time to return to
work was a significant predictor of financial burden, and that donors in manual/skilled trade
occupations experienced greatest financial burden for each week away from work (65). Older age
at donation and nondirected (versus directed) donation were associated with significantly
C.Agnello SE 0192
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 196 of 569 PageID #:
390
decreased financial burden (65). Living donation may also affect ability to obtain life, disability,
and health insurance (66–68).
The National Organ Transplant Act has been clarified, to explicitly state that “reasonable payments
associated with… the expenses of travel, housing, and lost wages incurred by the donor” are legal
(69). Many states have enacted legislation to offer tax deductions or credits, or other benefits, to
living organ donors (70). These programs vary state by state, are underused, and have not been
studied with regard to effect on financial burden of donation. Trials of replacement of lost wages in
the donation process are being pilot-tested (71,72).
A 2016 convenience sample of informed consent forms for living donor and transplant candidate
evaluation from nine geographically diverse programs in the United States identified
misconceptions about defraying donation-related costs, reinforced by ambiguous language or
omissions in the donor informed consent documents (73). Living donor candidates should receive
counseling about financial costs and risks before donation, information about the availability of
legal cost replacement programs, and assistance in accessing legitimate cost replacement
programs. In 2016, the American Society of Transplantation launched an online financial toolkit to
help donor candidates learn about the finances of being a living organ donor; this dynamic
resource will be expanded and updated over time (74). An American Society of Transplantation
Living Donor Community of Practice work group has developed guidance to help transplant
centers maximize donor coverage and minimize financial consequences to donors (75).
Summary and Future Directions
The practice of living donation relies on the ethical principles of beneficence and nonmaleficence
(where the benefits to the recipient are great whereas the risks to the donor are justifiably low) as
well as donor autonomy after informed consent (where risks and uncertainties are fully disclosed)
(76). Understanding risks related to kidney health, surgical complications, and psychosocial
outcomes is vital for donors and their care providers, and defining knowns and unknowns can
inform future research and policy development priorities (Figure 2). However, focus on these key
outcomes important to donors is not intended to be comprehensive, and other outcomes (e.g.,
pregnancy risks, hypertension, metabolic conditions, and effect on relationships, family dynamics,
and lifestyle) are discussed elsewhere (13,14,19,24,77–85). Some adverse outcomes may only be
fully appreciated after decades of follow-up of large cohorts of donors with diverse demographic
characteristics. Ongoing commitment to strengthen the evidence base for donor candidate
evaluation, selection, and counseling, including longer follow-up in representative cohorts, well
designed use of integrated data sources (55), long-term registries (28), and advancement of tools
C.Agnello SE 0193
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 197 of 569 PageID #:
391
for tailored risk estimation (7,47,76,86,49), should remain a leading priority for researchers,
practitioners, and policymakers.
Figure 2.
🔍
Open in a new tab
Applying knowledge on outcomes important to donors can inform current counseling
and next steps for research and policy. Infographic prepared for this perspective by
Heather Hunt, JD, in collaboration with Alvin Thomas, MSPH.
Disclosures
None.
Acknowledgments
Heather Hunt, JD, and Alvin Thomas, MSPH, collaborated in preparing the original infographic for
this article and grant permission for its use. Ms. Hunt is president of LIVE ON Organ Donation, Inc.,
C.Agnello SE 0194
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 198 of 569 PageID #:
392
a nonprofit organization that raises money to support living organ donors’ nonmedical expenses,
and is vice chair of the Organ Procurement and Transplantation Network (OPTN)/United Network
for Organ Sharing (UNOS) Living Donor Committee. Mr. Thomas is a student in the Department of
Epidemiology at the University of North Carolina at Chapel Hill.
Footnotes
Published online ahead of print. Publication date available at www.cjasn.org .
See related Commentary, “Commentary on Risks of Living Kidney Donation: Current State of
Knowledge on Core Outcomes Important to Donors,” on pages 609–610.
References
1. OPTN (Organ Procurement and Transplantation Network)/UNOS (United Network for
Organ Sharing): National Data Reports, Donors Recovered in the U.S. by Donor Type, Latest
Data. Available at: https://optn.transplant.hrsa.gov/data/view-data-reports/national-
data/ . Accessed July 27, 2018
2. Global Observatory on Donation and Transplantation: Kidney Transplants (Year 2016).
Available at: http://www.transplant-observatory.org/countkidney/ . Accessed August 18,
2018
3. Gordon EJ: Living organ donors’ stories: (unmet) Expectations about informed consent,
outcomes, and care. Narrat Inq Bioeth 2: 1–6, 2012 [DOI ] [PubMed] [Google Scholar ]
4. Ommen ES, Winston JA, Murphy B: Medical risks in living kidney donors: Absence of
proof is not proof of absence. Clin J Am Soc Nephrol 1: 885–895, 2006 [DOI ] [PubMed]
[Google Scholar ]
5. Lentine KL, Patel A: Risks and outcomes of living donation. Adv Chronic Kidney Dis 19:
220–228, 2012 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
6. Lentine KL, Segev DL: Health outcomes among non-caucasian living kidney donors:
Knowns and unknowns. Transpl Int 26: 853–864, 2013 [DOI ] [PubMed] [Google
Scholar ]
C.Agnello SE 0195
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 199 of 569 PageID #:
393
7. Lentine KL, Segev DL: Understanding and communicating medical risks for living kidney
donors: A matter of perspective. J Am Soc Nephrol 28: 12–24, 2017 [DOI ] [PMC free
article] [PubMed] [Google Scholar ]
8. Gross CR, Messersmith EE, Hong BA, Jowsey SG, Jacobs C, Gillespie BW, Taler SJ, Matas AJ,
Leichtman A, Merion RM, Ibrahim HN; RELIVE Study Group: Health-related quality of life in
kidney donors from the last five decades: Results from the RELIVE study. Am J Transplant
13: 2924–2934, 2013 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
9. Clemens K, Boudville N, Dew MA, Geddes C, Gill JS, Jassal V, Klarenbach S, Knoll G,
Muirhead N, Prasad GV, Storsley L, Treleaven D, Garg AX; Donor Nephrectomy Outcomes
Research (DONOR) Network: The long-term quality of life of living kidney donors: A
multicenter cohort study. Am J Transplant 11: 463–469, 2011 [DOI ] [PubMed] [Google
Scholar ]
10. Lentine KL, Schnitzler MA, Xiao H, Saab G, Salvalaggio PR, Axelrod D, Davis CL, Abbott
KC, Brennan DC: Racial variation in medical outcomes among living kidney donors. N Engl J
Med 363: 724–732, 2010 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
11. Lentine KL, Schnitzler MA, Xiao H, Davis CL, Axelrod D, Abbott KC, Salvalaggio PR,
Burroughs TE, Saab G, Brennan DC: Associations of recipient illness history with
hypertension and diabetes after living kidney donation. Transplantation 91: 1227–1232,
2011 [DOI ] [PubMed] [Google Scholar ]
12. Lentine KL, Schnitzler MA, Xiao H, Axelrod D, Davis CL, McCabe M, Brennan DC, Leander
S, Garg AX, Waterman AD: Depression diagnoses after living kidney donation: Linking U.S.
Registry data and administrative claims. Transplantation 94: 77–83, 2012 [DOI ] [PMC free
article] [PubMed] [Google Scholar ]
13. Lentine KL, Vijayan A, Xiao H, Schnitzler MA, Davis CL, Garg AX, Axelrod D, Abbott KC,
Brennan DC: Cancer diagnoses after living kidney donation: Linking U.S. Registry data and
administrative claims. Transplantation 94: 139–144, 2012 [DOI ] [PMC free article]
[PubMed] [Google Scholar ]
14. Lentine KL, Schnitzler MA, Garg AX, Xiao H, Axelrod D, Tuttle-Newhall JE, Brennan DC,
Segev DL: Understanding antihypertensive medication use after living kidney donation
through linked national registry and pharmacy claims data. Am J Nephrol 40: 174–183,
2014 [DOI ] [PubMed] [Google Scholar ]
C.Agnello SE 0196
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 200 of 569 PageID #:
394
15. Lentine KL, Schnitzler MA, Xiao H, Axelrod D, Garg AX, Tuttle-Newhall JE, Brennan DC,
Segev DL: Consistency of racial variation in medical outcomes among publicly and privately
insured living kidney donors. Transplantation 97: 316–324, 2014 [DOI ] [PMC free article]
[PubMed] [Google Scholar ]
16. Lentine KL, Lam NN, Schnitzler MA, Garg AX, Xiao H, Leander SE, Brennan DC, Taler SJ,
Axelrod D, Segev DL: Gender differences in use of prescription narcotic medications among
living kidney donors. Clin Transplant 29: 927–937, 2015 [DOI ] [PMC free article]
[PubMed] [Google Scholar ]
17. Lentine KL, Schnitzler MA, Garg AX, Xiao H, Axelrod D, Tuttle-Newhall JE, Brennan DC,
Segev DL: Race, relationship and renal diagnoses after living kidney donation.
Transplantation 99: 1723–1729, 2015 [DOI ] [PMC free article] [PubMed] [Google
Scholar ]
18. Lentine KL, Lam NN, Axelrod D, Schnitzler MA, Garg AX, Xiao H, Dzebisashvili N, Schold
JD, Brennan DC, Randall H, King EA, Segev DL: Perioperative complications after living
kidney donation: A national study. Am J Transplant 16: 1848–1857, 2016 [DOI ] [PubMed]
[Google Scholar ]
19. Lentine KL, Lam NN, Schnitzler MA, Hess GP, Kasiske BL, Xiao H, Axelrod D, Garg AX,
Schold JD, Randall H, Dzebisashvili N, Brennan DC, Segev DL: Predonation prescription
opioid use: A novel risk factor for readmission after living kidney donation. Am J Transplant
17: 744–753, 2017 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
20. Segev DL, Muzaale AD, Caffo BS, Mehta SH, Singer AL, Taranto SE, McBride MA,
Montgomery RA: Perioperative mortality and long-term survival following live kidney
donation. JAMA 303: 959–966, 2010 [DOI ] [PubMed] [Google Scholar ]
21. Muzaale AD, Massie AB, Wang M-C, Montgomery RA, McBride MA, Wainright JL, Segev
DL: Risk of end-stage renal disease following live kidney donation. JAMA 311: 579–586,
2014 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
22. Mjøen G, Hallan S, Hartmann A, Foss A, Midtvedt K, Øyen O, Reisæter A, Pfeffer P, Jenssen
T, Leivestad T, Line PD, Øvrehus M, Dale DO, Pihlstrøm H, Holme I, Dekker FW, Holdaas H:
Long-term risks for kidney donors. Kidney Int 86: 162–167, 2014 [DOI ] [PubMed] [Google
Scholar ]
23. Garg AX, Nevis IF, McArthur E, Sontrop JM, Koval JJ, Lam NN, Hildebrand AM, Reese PP,
Storsley L, Gill JS, Segev DL, Habbous S, Bugeja A, Knoll GA, Dipchand C, Monroy-Cuadros M,
C.Agnello SE 0197
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 201 of 569 PageID #:
395
Lentine KL; DONOR Network: Gestational hypertension and preeclampsia in living kidney
donors. N Engl J Med 372: 124–133, 2015 [DOI ] [PMC free article] [PubMed] [Google
Scholar ]
24. Lam NN, McArthur E, Kim SJ, Prasad GV, Lentine KL, Reese PP, Kasiske BL, Lok CE,
Feldman LS, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network; Donor
Nephrectomy Outcomes Research DONOR Network: Gout after living kidney donation: A
matched cohort study. Am J Kidney Dis 65: 925–932, 2015 [DOI ] [PubMed] [Google
Scholar ]
25. Lam N, Huang A, Feldman LS, Gill JS, Karpinski M, Kim J, Klarenbach SW, Knoll GA,
Lentine KL, Nguan CY, Parikh CR, Prasad GV, Treleaven DJ, Young A, Garg AX; Donor
Nephrectomy Outcomes Research (DONOR) Network: Acute dialysis risk in living kidney
donors. Nephrol Dial Transplant 27: 3291–3295, 2012 [DOI ] [PMC free article] [PubMed]
[Google Scholar ]
26. Organ Procurement and Transplantation Network/United Network for Organ Sharing:
Policy 14: Living Donation, 2018. Available at:
http://optn.transplant.hrsa.gov/governance/policies/ . Accessed July 27, 2018
27. Lentine KL, Kasiske BL, Levey AS, Adams PL, Alberú J, Bakr MA, Gallon L, Garvey CA,
Guleria S, Li PK, Segev DL, Taler SJ, Tanabe K, Wright L, Zeier MG, Cheung M, Garg AX:
KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors.
Transplantation 101[Suppl 1]: S1–S109, 2017 [DOI ] [PMC free article] [PubMed] [Google
Scholar ]
28. Kasiske BL, Asrani SK, Dew MA, Henderson ML, Henrich C, Humar A, Israni AK, Lentine
KL, Matas AJ, Newell KA, LaPointe Rudow D, Massie AB, Snyder JJ, Taler SJ, Trotter JF,
Waterman AD; Living Donor Collective Participants: The living donor collective: A scientific
registry for living donors. Am J Transplant 17: 3040–3048, 2017 [DOI ] [PubMed] [Google
Scholar ]
29. Suwelack B, Wö rmann V, Berger K, Gerß J, Wolters H, Vitinius F, Burgmer M; German
SoLKiD Consortium: Investigation of the physical and psychosocial outcomes after living
kidney donation - a multicenter cohort study (SoLKiD - safety of Living Kidney Donors).
BMC Nephrol 19: 83, 2018 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
30. Hanson CS, Chapman JR, Gill JS, Kanellis J, Wong G, Craig JC, Teixeira-Pinto A, Chadban
SJ, Garg AX, Ralph AF, Pinter J, Lewis JR, Tong A: Identifying outcomes that are important to
C.Agnello SE 0198
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 202 of 569 PageID #:
396
living kidney donors: A nominal group technique study. Clin J Am Soc Nephrol 13: 916–926,
2018 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
31. Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan
B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group: Mood, body image, fear of
kidney failure, life satisfaction, and decisional stability following living kidney donation:
Findings from the KDOC study. Am J Transplant 18: 1397–1407, 2018 [DOI ] [PMC free
article] [PubMed] [Google Scholar ]
32. Ruck JM, Van Pilsum Rasmussen SE, Henderson ML, Massie AB, Segev DL: Interviews of
living kidney donors to assess donation-related concerns and information-gathering
practices. BMC Nephrol 19: 130, 2018 [DOI ] [PMC free article] [PubMed] [Google
Scholar ]
33. Kasiske BL, Anderson-Haag T, Ibrahim HN, Pesavento TE, Weir MR, Nogueira JM, Cosio
FG, Kraus ES, Rabb HH, Kalil RS, Posselt AA, Kimmel PL, Steffes MW: A prospective
controlled study of kidney donors: Baseline and 6-month follow-up. Am J Kidney Dis 62:
577–586, 2013 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
34. Pabico RC, McKenna BA, Freeman RB: Renal function before and after unilateral
nephrectomy in renal donors. Kidney Int 8: 166–175, 1975 [DOI ] [PubMed] [Google
Scholar ]
35. Kasiske BL, Anderson-Haag T, Israni AK, Kalil RS, Kimmel PL, Kraus ES, Kumar R, Posselt
AA, Pesavento TE, Rabb H, Steffes MW, Snyder JJ, Weir MR: A prospective controlled study of
living kidney donors: Three-year follow-up. Am J Kidney Dis 66: 114–124, 2015 [DOI ]
[PMC free article] [PubMed] [Google Scholar ]
36. Garg AX, Muirhead N, Knoll G, Yang RC, Prasad GV, Thiessen-Philbrook H, Rosas-Arellano
MP, Housawi A, Boudville N; Donor Nephrectomy Outcomes Research (DONOR) Network:
Proteinuria and reduced kidney function in living kidney donors: A systematic review, meta-
analysis, and meta-regression. Kidney Int 70: 1801–1810, 2006 [DOI ] [PubMed] [Google
Scholar ]
37. Lenihan CR, Busque S, Derby G, Blouch K, Myers BD, Tan JC: Longitudinal study of living
kidney donor glomerular dynamics after nephrectomy. J Clin Invest 125: 1311–1318, 2015
[DOI ] [PMC free article] [PubMed] [Google Scholar ]
38. Matas AJ, Vock DM, Ibrahim HN: GFR ≤25 years postdonation in living kidney donors
with (vs. without) a first-degree relative with ESRD. Am J Transplant 18: 625–631, 2018
C.Agnello SE 0199
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 203 of 569 PageID #:
397
[DOI ] [PMC free article] [PubMed] [Google Scholar ]
39. Miller PL, Rennke HG, Meyer TW: Glomerular hypertrophy accelerates hypertensive
glomerular injury in rats. Am J Physiol 261: F459–F465, 1991 [DOI ] [PubMed] [Google
Scholar ]
40. Ibrahim HN, Foley RN, Reule SA, Spong R, Kukla A, Issa N, Berglund DM, Sieger GK, Matas
AJ: Renal function profile in white kidney donors: The first 4 decades. J Am Soc Nephrol 27:
2885–2893, 2016 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
41. Ibrahim HN, Foley R, Tan L, Rogers T, Bailey RF, Guo H, Gross CR, Matas AJ: Long-term
consequences of kidney donation. N Engl J Med 360: 459–469, 2009 [DOI ] [PMC free
article] [PubMed] [Google Scholar ]
42. Fehrman-Ekholm I, Duné r F, Brink B, Tydé n G, Elinder CG: No evidence of accelerated
loss of kidney function in living kidney donors: Results from a cross-sectional follow-up.
Transplantation 72: 444–449, 2001 [DOI ] [PubMed] [Google Scholar ]
43. Fournier C, Pallet N, Cherqaoui Z, Pucheu S, Kreis H, Mé jean A, Timsit MO, Landais P,
Legendre C: Very long-term follow-up of living kidney donors. Transpl Int 25: 385–390,
2012 [DOI ] [PubMed] [Google Scholar ]
44. Gill JS, Tonelli M: Understanding rare adverse outcomes following living kidney
donation. JAMA 311: 577–579, 2014 [DOI ] [PubMed] [Google Scholar ]
45. Anjum S, Muzaale AD, Massie AB, Bae S, Luo X, Grams ME, Lentine KL, Garg AX, Segev
DL: Patterns of end-stage renal disease caused by diabetes, hypertension, and
glomerulonephritis in live kidney donors. Am J Transplant 16: 3540–3547, 2016 [DOI ]
[PMC free article] [PubMed] [Google Scholar ]
46. Matas AJ, Berglund DM, Vock DM, Ibrahim HN: Causes and timing of end-stage renal
disease after living kidney donation. Am J Transplant 18: 1140–1150, 2018 [DOI ]
[PubMed] [Google Scholar ]
47. Grams ME, Sang Y, Levey AS, Matsushita K, Ballew S, Chang AR, Chow EK, Kasiske BL,
Kovesdy CP, Nadkarni GN, Shalev V, Segev DL, Coresh J, Lentine KL, Garg AX; Chronic Kidney
Disease Prognosis Consortium: Kidney-failure risk projection for the living kidney-donor
candidate. N Engl J Med 374: 411–421, 2016 [DOI ] [PMC free article] [PubMed] [Google
Scholar ]
C.Agnello SE 0200
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 204 of 569 PageID #:
398
48. Massie AB, Muzaale AD, Luo X, Chow EKH, Locke JE, Nguyen AQ, Henderson ML, Snyder
JJ, Segev DL: Quantifying postdonation risk of ESRD in living kidney donors. J Am Soc
Nephrol 28: 2749–2755, 2017 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
49. Hosseini K, Omorou AY, Hubert J, Ngueyon Sime W, Ladriere M, Guillemin F:
Nephrectomy complication is a risk factor of clinically meaningful decrease in health utility
among living kidney donors. Value Health 20: 1376–1382, 2017. [DOI ] [PubMed]
50. Rodrigue JR, Vishnevsky T, Fleishman A, Brann T, Evenson AR, Pavlakis M, Mandelbrot
DA: Patient-reported outcomes following living kidney donation: A single center experience.
J Clin Psychol Med Settings 22: 160–168, 2015 [DOI ] [PMC free article] [PubMed] [Google
Scholar ]
51. Wilson CH, Sanni A, Rix DA, Soomro NA: Laparoscopic versus open nephrectomy for live
kidney donors. Cochrane Database Syst Rev (11): CD006124, 2011 [DOI ] [PubMed]
[Google Scholar ]
52. Yuan H, Liu L, Zheng S, Yang L, Pu C, Wei Q, Han P: The safety and efficacy of
laparoscopic donor nephrectomy for renal transplantation: An updated meta-analysis.
Transplant Proc 45: 65–76, 2013 [DOI ] [PubMed] [Google Scholar ]
53. Matas AJ, Bartlett ST, Leichtman AB, Delmonico FL: Morbidity and mortality after living
kidney donation, 1999-2001: Survey of United States transplant centers. Am J Transplant 3:
830–834, 2003 [PubMed] [Google Scholar ]
54. Schold JD, Goldfarb DA, Buccini LD, Rodrigue JR, Mandelbrot DA, Heaphy EL, Fatica RA,
Poggio ED: Comorbidity burden and perioperative complications for living kidney donors in
the United States. Clin J Am Soc Nephrol 8: 1773–1782, 2013 [DOI ] [PMC free article]
[PubMed] [Google Scholar ]
55. Lentine KL, Segev DL: Better understanding live donor risk through big data. Clin J Am
Soc Nephrol 8: 1645–1647, 2013 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
56. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañ es E,
Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M:
The clavien-dindo classification of surgical complications: Five-year experience. Ann Surg
250: 187–196, 2009 [DOI ] [PubMed] [Google Scholar ]
57. Mjøen G, Øyen O, Holdaas H, Midtvedt K, Line PD: Morbidity and mortality in 1022
consecutive living donor nephrectomies: Benefits of a living donor registry. Transplantation
C.Agnello SE 0201
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 205 of 569 PageID #:
399
88: 1273–1279, 2009 [DOI ] [PubMed] [Google Scholar ]
58. Rodríguez Faba O, Boissier R, Budde K, Figueiredo A, Taylor CF, Hevia V, Lledó García E,
Regele H, Zakri RH, Olsburgh J, Breda A: European association of urology guidelines on
renal transplantation: Update 2018. Eur Urol Focus 4: 208–215, 2018 [DOI ] [PubMed]
[Google Scholar ]
59. Wirken L, van Middendorp H, Hooghof CW, Rovers MM, Hoitsma AJ, Hilbrands LB, Evers
AW: The course and predictors of health-related quality of life in living kidney donors: A
systematic review and meta-analysis. Am J Transplant 15: 3041–3054, 2015 [DOI ]
[PubMed] [Google Scholar ]
60. Ruck JM, Holscher CM, Purnell TS, Massie AB, Henderson ML, Segev DL: Factors
associated with perceived donation-related financial burden among living kidney donors.
Am J Transplant 18: 715–719, 2018 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
61. Clarke KS, Klarenbach S, Vlaicu S, Yang RC, Garg AX; Donor Nephrectomy Outcomes
Research (DONOR) Network: The direct and indirect economic costs incurred by living
kidney donors-a systematic review. Nephrol Dial Transplant 21: 1952–1960, 2006 [DOI ]
[PubMed] [Google Scholar ]
62. Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan
B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group: Predonation direct and
indirect costs incurred by adults who donated a kidney: Findings from the KDOC study. Am J
Transplant 15: 2387–2393, 2015 [DOI ] [PMC free article] [PubMed] [Google Scholar ]
63. Klarenbach S, Gill JS, Knoll G, Caulfield T, Boudville N, Prasad GV, Karpinski M, Storsley L,
Treleaven D, Arnold J, Cuerden M, Jacobs P, Garg AX; Donor Nephrectomy Outcomes
Research (DONOR) Network: Economic consequences incurred by living kidney donors: A
Canadian multi-center prospective study. Am J Transplant 14: 916–922, 2014 [DOI ] [PMC
free article] [PubMed] [Google Scholar ]
64. Przech S, Garg AX, Arnold JB, Barnieh L, Cuerden MS, Dipchand C, Feldman L, Gill JS,
Karpinski M, Knoll G, Lok C, Miller M, Monroy M, Nguan C, Prasad GVR, Sarma S, Sontrop JM,
Storsley L, Klarenbach S; Donor Nephrectomy Outcomes Research (DONOR) Network:
Financial costs incurred by living kidney donors: A prospective cohort study. J Am Soc
Nephrol 29: 2847–2857, 2018. [DOI ] [PMC free article] [PubMed]
65. Larson DB, Wiseman JF, Vock DM, Berglund DM, Roman AM, Ibrahim HN, Matas AJ:
Financial burden associated with time to return to work after living kidney donation. Am J
C.Agnello SE 0202
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 206 of 569 PageID #:
400
Transplant 19: 204–207, 2018 [DOI ] [PubMed] [Google Scholar ]
66. Yang RC, Thiessen-Philbrook H, Klarenbach S, Vlaicu S, Garg AX; Donor Nephrectomy
Outcomes Research (DONOR) Network: Insurability of living organ donors: A systematic
review. Am J Transplant 7: 1542–1551, 2007 [DOI ] [PubMed] [Google Scholar ]
67. Yang RC, Young A, Nevis IF, Lee D, Jain AK, Dominic A, Pullenayegum E, Klarenbach S,
Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network: Life insurance for
living kidney donors: A Canadian undercover investigation. Am J Transplant 9: 1585–1590,
2009 [DOI ] [PubMed] [Google Scholar ]
68. Boyarsky BJ, Massie AB, Alejo JL, Van Arendonk KJ, Wildonger S, Garonzik-Wang JM,
Montgomery RA, Deshpande NA, Muzaale AD, Segev DL: Experiences obtaining insurance
after live kidney donation. Am J Transplant 14: 2168–2172, 2014 [DOI ] [PMC free article]
[PubMed] [Google Scholar ]
69. Lapointe Rudow D, Cohen D: Practical approaches to mitigating economic barriers to
living kidney donation for patients and programs. Curr Transpl Rep 4: 24–31, 2017 [Google
Scholar ]
70. Lacetera N, Macis M, Stith SS: Removing financial barriers to organ and bone marrow
donation: The effect of leave and tax legislation in the U.S. J Health Econ 33: 43–56, 2014
[DOI ] [PubMed] [Google Scholar ]
71. Hays R: Informed consent of living kidney donors: Pitfalls and best practices. Curr
Transplant Rep 2: 29–34, 2015 [Google Scholar ]
72. Rodrigue JR, Fleishman A, Carroll M, Evenson AR, Pavlakis M, Mandelbrot DA, Baliga P,
Howard DH, Schold JD: The living donor lost wages trial: Study rationale and protocol. Curr
Transplant Rep 5: 45–54, 2018 [PMC free article] [PubMed] [Google Scholar ]
73. Mittelman M, Thiessen C, Chon WJ, Clayville K, Cronin DC, Fisher JS, Fry-Revere S, Gross
JA, Hanneman J, Henderson ML, Ladin K, Mysel H, Sherman LA, Willock L, Gordon EJ:
Miscommunicating NOTA can Be costly to living donors. Am J Transplant 17: 578–580, 2017
[DOI ] [PubMed] [Google Scholar ]
74. American Society of Transplantation: Live Donor Toolkit: Resources for Those
Consdiering Live Donation - Financial Toolkit, 2017. Available at:
http://www.livedonortoolkit.com/financial-toolkit . Accessed July 30, 2018
C.Agnello SE 0203
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 207 of 569 PageID #:
401
75. Tietjen A, Hays R, McNatt G, Howey R, Lebron-Banks U, Thomas CP, Lentine KL: Billing
for living kidney donor care: Balancing cost recovery, regulatory compliance, and minimized
donor burden. Curr Transplant Rep 2019, in press [DOI ] [PMC free article] [PubMed]
[Google Scholar ]
76. Thiessen C, Gordon EJ, Reese PP, Kulkarni S: Development of a donor-centered approach
to risk assessment: Rebalancing nonmaleficence and autonomy. Am J Transplant 15: 2314–
2323, 2015 [DOI ] [PubMed] [Google Scholar ]
77. Lam NN, Garg AX, Segev DL, Schnitzler MA, Xiao H, Axelrod D, Brennan DC, Kasiske BL,
Tuttle-Newhall JE, Lentine KL: Gout after living kidney donation: Correlations with
demographic traits and renal complications. Am J Nephrol 41: 231–240, 2015 [DOI ] [PMC
free article] [PubMed] [Google Scholar ]
78. Garg AX, McArthur E, Lentine KL; Donor Nephrectomy Outcomes Research (DONOR)
Network: Gestational hypertension and preeclampsia in living kidney donors. N Engl J Med
372: 1469–1470, 2015 [DOI ] [PubMed] [Google Scholar ]
79. Garg AX, Pouget J, Young A, Huang A, Boudville N, Hodsman A, Adachi JD, Leslie WD,
Cadarette SM, Lok CE, Monroy-Cuadros M, Prasad GV, Thomas SM, Naylor K, Treleavan D;
Donor Nephrectomy Outcomes Research (DONOR) Network: Fracture risk in living kidney
donors: A matched cohort study. Am J Kidney Dis 59: 770–776, 2012 [DOI ] [PubMed]
[Google Scholar ]
80. Garg AX, Meirambayeva A, Huang A, Kim J, Prasad GV, Knoll G, Boudville N, Lok C,
McFarlane P, Karpinski M, Storsley L, Klarenbach S, Lam N, Thomas SM, Dipchand C, Reese
P, Doshi M, Gibney E, Taub K, Young A; Donor Nephrectomy Outcomes Research Network:
Cardiovascular disease in kidney donors: Matched cohort study. BMJ 344: e1203, 2012
[DOI ] [PMC free article] [PubMed] [Google Scholar ]
81. Slinin Y, Brasure M, Eidman K, Bydash J, Maripuri S, Carlyle M, Ishani A, Wilt TJ: Long-
term outcomes of living kidney donation. Transplantation 100: 1371–1386, 2016 [DOI ]
[PubMed] [Google Scholar ]
82. Clemens KK, Thiessen-Philbrook H, Parikh CR, Yang RC, Karley ML, Boudville N, Ramesh
Prasad GV, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network:
Psychosocial health of living kidney donors: A systematic review. Am J Transplant 6: 2965–
2977, 2006 [DOI ] [PubMed] [Google Scholar ]
C.Agnello SE 0204
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 208 of 569 PageID #:
402
83. Ralph AF, Butow P, Hanson CS, Chadban SJ, Chapman JR, Craig JC, Kanellis J, Luxton G,
Tong A: Donor and recipient views on their relationship in living kidney donation: Thematic
synthesis of qualitative studies. Am J Kidney Dis 69: 602–616, 2017 [DOI ] [PubMed]
[Google Scholar ]
84. Thys K, Schwering KL, Siebelink M, Dobbels F, Borry P, Schotsmans P, Aujoulat I,
Donation EPO; ELPAT Pediatric Organ Donation and Transplantation Working Group:
Psychosocial impact of pediatric living-donor kidney and liver transplantation on recipients,
donors, and the family: A systematic review. Transpl Int 28: 270–280, 2015 [DOI ]
[PubMed] [Google Scholar ]
85. Lam NN, Lentine KL, Levey AS, Kasiske BL, Garg AX: Long-term medical risks to the
living kidney donor. Nat Rev Nephrol 11: 411–419, 2015 [DOI ] [PubMed] [Google
Scholar ]
86. Steiner RW: Risk appreciation for living kidney donors: Another new subspecialty? Am J
Transplant 4: 694–697, 2004 [DOI ] [PubMed] [Google Scholar ]
87. Gibney EM, King AL, Maluf DG, Garg AX, Parikh CR: Living kidney donors requiring
transplantation: Focus on african Americans. Transplantation 84: 647–649, 2007 [DOI ]
[PubMed] [Google Scholar ]
88. Cherikh WS, Young CJ, Kramer BF, Taranto SE, Randall HB, Fan PY: Ethnic and gender
related differences in the risk of end-stage renal disease after living kidney donation. Am J
Transplant 11: 1650–1655, 2011 [DOI ] [PubMed] [Google Scholar ]
89. Locke JE, Reed RD, Massie A, MacLennan PA, Sawinski D, Kumar V, Mehta S, Mannon RB,
Gaston R, Lewis CE, Segev DL: Obesity increases the risk of end-stage renal disease among
living kidney donors. Kidney Int 91: 699–703, 2017 [DOI ] [PMC free article] [PubMed]
[Google Scholar ]
90. Serrano OK, Sengupta B, Bangdiwala A, Vock DM, Dunn TB, Finger EB, Pruett TL, Matas
AJ, Kandaswamy R: Implications of excess weight on kidney donation: Long-term
consequences of donor nephrectomy in obese donors. Surgery 164: 1071–1076, 2018
[DOI ] [PubMed] [Google Scholar ]
91. Wainright JL, Robinson AM, Wilk AR, Klassen DK, Cherikh WS, Stewart DE: Risk of ESRD
in prior living kidney donors. Am J Transplant 18: 1129–1139, 2018 [DOI ] [PubMed]
[Google Scholar ]
C.Agnello SE 0205
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 209 of 569 PageID #:
403
Articles from Clinical Journal of the American Society of Nephrology : CJASN are provided here
courtesy of American Society of Nephrology
C.Agnello SE 0206
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 210 of 569 PageID #:
404
EXHIBIT K
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0207
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 211 of 569 PageID #:
405 2011 The Authors
American Journal of Transplantation 2011; 11: 2093–2109 C
Wiley Periodicals Inc. 2011 The American Society of
Journal compilation C
Transplantation and the American Society of Transplant Surgeons
doi: 10.1111/j.1600-6143.2011.03686.x
Systematic Review: Kidney Transplantation Compared
With Dialysis in Clinically Relevant Outcomes
M. Tonellia,∗ , N. Wiebea , G. Knollb , A. Belloa , survey; SIP, sickness impact profile; TTO, time trade
S. Brownec , D. Jadhavb , S. Klarenbacha off; WHO-QoL, World Health Organization quality of
life; 15D, Finnish 15 dimensions.
and J. Gillc
Received 27 April 2011, revised 02 June 2011 and
a
Department of Medicine, University of Alberta, accepted for publication 14 June 2011
Edmonton, Alberta, Canada
b
Department of Medicine, University of Ottawa, Ottawa,
Ontario, Canada
c
Department of Medicine, University of British Columbia, Introduction
Vancouver, British Columbia, Canada
*Corresponding author: Marcello Tonelli, Available treatments for end-stage renal disease (ESRD)
no_reprints@med.ualberta.ca include dialysis and kidney transplantation (1,2). Increasing
prevalence of ESRD, together with stable or declining rates
Individual studies indicate that kidney transplantation of organ donation have led to a critical shortage of kidneys
is associated with lower mortality and improved qual- available for transplantation (3,4). The median interval be-
ity of life compared with chronic dialysis treatment. tween placement on a transplant waiting list and receipt of
We did a systematic review to summarize the bene- a kidney transplant from a deceased donor has dramatically
fits of transplantation, aiming to identify characteris- increased in recent years, and currently ranges between 3
tics associated with especially large or small relative and 7 years for North American patients with kidney failure,
benefit. Results were not pooled because of expected depending on region of residence (5). At the same time,
diversity inherent to observational studies. Risk of bias
the age and comorbidity of patients who are treated with
was assessed using the Downs and Black checklist
and items related to time-to-event analysis techniques. dialysis continues to increase (6).
MEDLINE and EMBASE were searched up to February
2010. Cohort studies comparing adult chronic dialysis Individual studies indicate that kidney transplantation is as-
patients with kidney transplantation recipients for clin- sociated with lower mortality and improved quality of life
ical outcomes were selected. We identified 110 eligible compared with chronic dialysis treatment (7,8). However,
studies with a total of 1 922 300 participants. Most factors that are associated with greater or lesser bene-
studies found significantly lower mortality associated fit from transplantation are poorly described. In addition,
with transplantation, and the relative magnitude of there has been little or no systematic exploration of how
the benefit seemed to increase over time (p < 0.001). the relative benefits of transplantation (compared to dialy-
Most studies also found that the risk of cardiovascu-
sis) have varied over time, given that contemporary dialysis
lar events was significantly reduced among transplant
recipients. Quality of life was significantly and sub- patients are older and sicker (6), but must wait longer to
stantially better among transplant recipients. Despite receive a kidney transplant than those in previous years
increases in the age and comorbidity of contemporary (3,9).
transplant recipients, the relative benefits of transplan-
tation seem to be increasing over time. These find- We did a systematic review to summarize the antici-
ings validate current attempts to increase the num- pated clinical benefit associated with kidney transplanta-
ber of people worldwide that benefit from kidney tion (compared with dialysis) in the current era. We also
transplantation. aimed to identify characteristics associated with especially
large or small relative benefit, compared to dialysis.
Key words: Cardiovascular events, dialysis, hospital-
ization, kidney transplantation, mortality, quality of life
Materials and Methods
Abbreviations: ESRD, end-stage renal disease; EQ-
5D, European quality of life-5 dimensions; GHQ, gen- Data sources and searches
eral health questionnaire; HR, hazard ratio; HUI, health This systematic review is reported according to published guidelines (10).
utility index; KDQoL, kidney disease quality of life; An expert librarian conducted a comprehensive search to identify all rel-
QoL, quality of life; SES, socio-economic status; SF- evant studies regardless of publication status. Nonenglish articles were
36, Medical Outcomes Study 36-item short-form health included where an appropriate translator was available. Three electronic
2093
C.Agnello SE 0208
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 212 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
406
Tonelli et al.
databases, MEDLINE (1950–February 25, 2010), EMBASE (1980–February to statistically combine results. To facilitate comparison, we present indi-
25, 2010), and all evidence-based medicine reviews (September 7, 2007) vidual study summary statistics in unpooled metagraphs using R software.
were searched. The detailed search strategies are included in the Sup- Dichotomous outcomes (e.g. mortality) are summarized using the unad-
porting Information. A content expert and a methodologist screened each justed risk ratio and all available adjusted ratios (i.e. hazard ratio [HR], risk
citation or abstract. Any study considered potentially relevant by at least ratio, odds ratio, rate ratio; depending on what was reported). Continuous
one reviewer was recovered for further review. outcomes (e.g. QoL) are summarized using the mean difference. Given
the presence of large heterogeneity, we did not formally assess for the
presence of publication bias (12).
Study selection
The full text of each potentially relevant study was independently assessed
We planned a priori to examine the following subgroups for evidence of ef-
by two reviewers for inclusion in the review using predetermined eligibil-
fect modification on the association between transplantation and mortality:
ity criteria on a preprinted form. Studies were eligible for inclusion if they
diabetic patients, elderly patients, patients with chronic infections (human
reported important clinical outcomes (mortality, cardiovascular events, hos-
immunodeficiency virus, hepatitis B or hepatitis C) and patients with cardio-
pitalization and quality of life [QoL]) in both a chronic dialysis population and
vascular disease. We were primarily interested in the results of formal tests
a kidney transplantation population. Pediatric studies (age < 16 years) and
for effect modification in the primary studies. Unfortunately, we did not iden-
studies including multi-organ transplantation were excluded. Studies had to
tify eligible studies for all of these subgroups. However, using multivariable
include at least 30 participants in each relevant treatment modality group.
meta-regression models (weighted least squares linear regression), we ex-
This minimum sample size was set to improve the efficiency of the work
amined whether era (midyear of the interval for inclusion of participants),
without an appreciable loss of power and to minimize bias (robust calcu-
restricting analyses to dialysis patients who were active on the kidney trans-
lations of standard deviation and to prevent small study bias). Multigroup
plantation waiting list, or elements of study design (prospective, retrospec-
cohort studies were included; crossover, case-control and cross-sectional
tive or registry) modified the relationship between unadjusted mortality
studies were excluded with one exception—we included cross-sectional
and modality. To minimize participant overlap (and ensure independence of
studies when QoL was reported. Disagreements were resolved by dis-
data) between studies in our meta-regression analyses, we restricted our
cussion and consultation with a third party. Reviewers agreed on study
pool of studies to unique combinations of region (or registry) and era of
selection for 89% of the articles (j = 0.66).
accrual. More current studies were given precedence; studies with special
populations were excluded (e.g. hepatitis positive).
Data extraction and risk of bias assessment
We assessed and reported risk of bias in included studies using items from
the Downs and Black checklist (11). These include items of study design (se- Results
lection of participants, allocation of participants and outcome definitions),
statistical analysis (calculation of sample size and adjustment for potential
Search yield
confounding) and results (losses to follow up). Post hoc, we included three
items specifically relevant to the time-to-event analyses in these studies:
From 32 166 identified citations, 732 articles were recov-
(1) selected time of origin (e.g. dialysis initiation or transplantation) and des- ered for detailed evaluation (Figure 1). Of these, 110 stud-
tination (e.g. modality failure, death), (2) adjustment for prior time spent on ies were eligible for inclusion in this review (Table 1). Study
renal replacement therapy and (3) modeling time-dependency of modality sample sizes ranged from 39 to 468 681 (median 501);
(i.e. attributing the time on dialysis for eventual transplant recipients and enrolment of study participants ranged from 1960 to 2006
graft failure patients to the dialysis hazard). Two reviewers independently and maximum duration of follow up ranged from 6 months
assessed each included study, and resolved disagreements with the aid of to 19 years.
a third party.
The following properties were extracted from each study: characteristics
Populations studied
(country, data source, era of accrual, duration of follow-up, special sub- Dialysis modalities considered in eligible studies in-
groups or populations, sample size and setting), participants (age, gender, cluded in-center hemodialysis, satellite hemodialysis,
race, body mass index, socio-economic status and comorbidities), renal home hemodialysis, nocturnal dialysis, peritoneal dialy-
replacement modality (living or deceased donor, hemodialysis, peritoneal sis and multiple modalities (populations including both
dialysis, etc.) and results (both unadjusted and adjusted, covariates, inter- hemodialysis and peritoneal dialysis). Transplantation used
actions and subgroups). The following outcomes were considered: all-cause allografts from deceased and living donors.
mortality, cardiac events (limited to myocardial infarction, stroke, heart fail-
ure and to the aggregate of any cardiac event), hospitalization (incidence,
Mean age of transplant recipients in the included stud-
rate, mean counts; limited to infection and all-cause) and QoL. Specifi-
ies ranged from 30 to 68 years (median 44); the major-
cally, the following QoL instruments were included: European quality of
life-5 dimensions (EQ-5D), time trade off (TTO), standard gamble, health
ity of patients were male (median 62%). We collected
utility index (HUI), Finnish 15 dimensions (15D), Medical Outcomes Study data on the proportion of patients in each group who
36-Item Short-Form Health Survey (SF-36), kidney disease quality of life had diabetes, coronary artery disease, hypertension, heart
(KDQoL), Karnofsky, sickness impact profile (SIP), general health question- failure, stroke, lung disease, peripheral vascular disease,
naire (GHQ), and World Health Organization quality of life (WHO-QoL). A malignancy, infectious disease and smoking status. Unfor-
second reviewer checked the data for accuracy. tunately, these data were reported very infrequently and so
are not reported here. Characteristics that were explored
Data synthesis and analysis by the included studies as potential determinants of the
Because identified studies were expected to be observational and, there- benefit of transplantation were hepatitis B and/or hepatitis
fore, both methodologically and clinically diverse, we decided a priori not C virus serostatus of the recipient (13,14) and donor (15),
2094 American Journal of Transplantation 2011; 11: 2093–2109
C.Agnello SE 0209
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 213 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
407
Systematic Review of Kidney Transplantation
Potentially relevant records identified through database searching (n=42714 )
and through other sources (n=26)
Duplicated records (n=10574 )
Potentially relevant records identified and screened for retrieval (n=32166 )
Records excluded (n=31434 )
Not relevant (n=31367 )
No translator found * (n=61)
Not retrievable (n=6)
Articles retrieved for detailed evaluation (n=732)
Articles excluded (n=621 )
No relevant comparison (n=212 )
No relevant outcome (n=171)
Not original research (n=117)
Sample size group <30 (n=45)
No usable data (n=35)
Pediatric (n=16)
Study design (n=13)
No ESRD (n=9)
Multiple publication (n=4)
*20 German, 6 Czech, 5 Dutch, Italian, Polish, Russian,
3 Japanese, 2 Chinese, Hungarian, Portugese, and 1 of
Studies included in the systematic review (n=110) the following: Croatian, Danish, Hebrew, Norwegian,
Serbian, and Yugoslavian
Figure 1: PRISMA flow diagram. PRISMA = preferred reporting items for systematic reviews and meta-analyses); ESRD = end-stage
renal disease. Details of the search strategies including data sources are in the Supporting Information.
extended-criteria donor (16,17), primary cause of ESRD of included studies is reported in Table S2 and summarized
(18–23), findings of coronary angiography (24,25), coronary in Figure 2.
artery bypass surgery (26), a low-protein diet (27), cancer
(28), diabetes (22,29–34), obesity (35), employment (36), Mortality
race (37–42) and age (7,43–47). In all, 163 cohorts (77 studies; 1 800 119 participants)
reported unadjusted comparisons of mortality associated
with transplantation as compared with dialysis. Of these,
Risk of bias assessment 76% found a significantly lower risk of death associated
All eligible studies used a cohort design: 26% were with transplantation and 7% found a significantly lower
prospective, 36% were based on registries with prospec- risk of death associated with dialysis (Figure S1).
tively collected data, 2% were ambispective (both prospec-
tive and retrospective data collection), 18% were retro- Six studies (7,38,46,48–50; 19 945 participants) reported
spective and 13% did not specify the relative timing of adjusted relative hazards for all-cause mortality in discrete
hypothesis generation and data collection. The risk of bias time periods (Figure 3). During the period immediately
American Journal of Transplantation 2011; 11: 2093–2109 2095
C.Agnello SE 0210
2096 Table 1: Clinical and demographic characteristics of included studies
Maximum
Author Accrual follow-up Sample Mean age Percent Percent
and year Country Source era (years) Population Treatment size (years) male diabetic
Tonelli et al.
Bayat (43) 2010 France Regional registry 1997–2003 7 60–80 years Tx/D 54/940 63 57 41
<60 years 280/221 62 21
Ansell (96) 2009 UK UKRR 1997–2006 1 − Tx/D 17,545/22, 115 − − −
Buturovic-Ponikvar (65) Slovenia ERA-EDTA 1998–2006 9 − Tx/HD; PD 461/1271; 103 52/65; 532 57/55; 59 14/24; 21
2009
Chauveau (27) 2009 France − 1985–2000 111 Low protein diet Tx/HD 101/102 42/62 52/- −
Griva (88) 2009 UK Two sites − None6 − Tx/HD; PD 117/77; 68 50/50 60/65 5/17
Jain (37) 2009 UK Multiple sites 1996–2000 42 White; Black; Tx/HD; PD 157/598 622 63 25
South Asian
Case 2:24-cr-00366-NJC
Kramer (70) 2009 Europe ERA-EDTA 1997–2006 10 − CTx; LTx/ HD; PD 20, 321; 2965/398, 46/63 63/61 12/22
871; 46, 524
Martin Navarro (16) Spain − 2000–2005 22 WL; nWL; ECD CTx/WL HD 31/164 68/74 64 35/20
2009
Pauly (59) 2009 Canada; USA USRDS; Regional 1994–2006 42 − CTx; LTx/Night 531; 531/177 47; 44/46 58; 57/65 14; 14/144
registry
Stel (97) 2009 Europe ERA-EDTA 2000–2004 2 − CTx; LTx/HD; PD 13,753; − − −
3505/7,137
Patel (98) 2008 UK Single site 2002–2005 32 − CTx/WL HD; PD 80/142 [78] 51 [54] 64 19 [39]
[nWL HD; PD]
Visnja (14) 2008 Serbia Single site 1987–2001 17 HBV+; Tx/WL HD 67/128 35/50 75/58 0/84
Document 24-1
HCV+; 39/83 36/55 69/48 5/8
C.Agnello Hep– 278/192 33/50 68/53 2/5
Chavers (52) 2007 USA USRDS 1996–2001 3 − Tx/HD; PD 31,663/333,453 <65/65–742 60/53 29/454
Gill (77) 2007 USA USRDS 1995–2003 − − CTx; LTx[GF]/WL D 47,433 [5,461]/41, 49 [48]/50 62 [61]/60 30 [25]/364
769 Filed 03/11/26
Sorenson (30) 2007 Denmark ERA-EDTA; 1994–2005 71 DM; nDM Tx/WL HD; PD [WL 1,239/517 [4,737] 41/49 [66] − 17/22 [24]
Multi-national HD; PD]
registry
SE 0211 Cheawchanwattana Thailand Single site 2005 None − Tx/HD; PD 133/107; 62 45/45; 57 65/60; 55 23/18; 47
(81) 2006
2
408
Snyder (31) 2006 USA USRDS 1995–2003 − DM; Tx/WL D 11,418/19,107 50–64 60/59 100
nDM 32,009/34,202 35–49 60/59 0
Yildirim (92) 2006 Turkey Multiple sites 2004–2005 None − Tx/HD; PD 356/104; 186 44/55; 46 56/46; 53 −
Zimmerman (55) 2006 Brazil Single site 1996–1997 None3 − Tx/HD 64/40 45 55 −
Borentain (25) 2005 France Single site 1995–2001 4 PTCA Tx/D 37/75 52/61 95/69 11/32
Buturovic-Ponikvar (99) Slovenia Multiple sites 2003 1 − Tx/HD; PD 374/1171; 116 − − −/19
2005
Ho (68) 2005 China Regional registry 1995–2004 7 − Tx/HD; PD 3,174/1,119; 5,149 49–552 ∼59/52; 49 12/23; 39
Lee (83) 2005 Wales Single site 2002 None − Tx/HD; PD 209/99; 74 53/63; 59 60/61; 51 −
Massad (26) 2005 USA Single site 1992–2004 − CABG Tx/HD; PD 32/62 58/58 59/63 50/76
Merion (17) 2005 USA National registry 1995–2002 10 ECD; CTx; LTx/D 7,790 [41,052]; 40–59 [40–59]; 62 [61]; −/58 27 [22];
nECD 15,203/45,082 −/40–592 −/354
Niu (100) 2005 Taiwan Two sites 2002 None − Tx/HD; PD 80/80; 80 43/55; 51 44/40; 43 −
Oniscu (49) 2005 UK Multiple regional 1989–1999 3 − CTx/WL HD; PD 1,095/641 43/53 61/62 12/194
registries
Schaubel (101) 2005 USA National registry 1999 3 − CTx; LTx/D 7,773/8,011 − − −
Continued.
American Journal of Transplantation 2011; 11: 2093–2109
Page 214 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Table 1: Continued
Maximum
Author Accrual follow-up Sample Mean age Percent Percent
and year Country Source era (years) Population Treatment size (years) male diabetic
Abbott (15) 2004 USA USRDS 1995–2000 6 HCV+donor; CAD/WL D 389; 51; 46/50 75; 63/60 30; 34/404
HCV–donor 16,495/17,044
Moe (102) 2004 USA Single site − 2 − Tx/HD 38/30 45/55 76/61 37/94
Oniscu (46) 2004 UK Multiple regional 1989–1999 11 ≥60 years Tx/HD; PD 128/197 64/66 65/59 13/16
registries
Schon (103) 2004 Sweden National registry 1991–2002 12 − CTx; LTx/HD; PD 721/3,052; 1,294 − − 17/33; 35
Sezer (13) 2004 Turkey Single site <1996 5 nDM: HCV+ HCV– CTx; LTx/HD CTx; 116/136 34/43 71/60 0
LTx/HD
Abbott (104) 2003 USA USRDS 1994–1997 − − Tx/HD; PD 19,033/16,182 43/47 61/58 31/364
Brunkhorst (19) 2003 Germany Regional registry 1978–1996 19 ESRD-DM; DM1 DM1; DN 46/46 43/45 69/69 100
Case 2:24-cr-00366-NJC
Glanton (35) 2003 USA USRDS 1995–1999 7 Obese CTx; LTx/HD; PD 1,719; 552/5,172 48 54 40
nObese CTx; LTx/HD; PD 4,795;
1,528/16,896
McDonald (40) 2003 Australia; New ANZDATA 1991–2000 9 nIndigenous; ATSI; Tx/HD; PD 12,984 602 59 174
Zealand
Pacific; 1,061 48 43 47
Maori 502 51 48 55
935 44 57 63
Tomasz (105) 2003 Poland Two sites − None − Tx/HD 83/61 43/58 52/56 −
Baiardi (80) 2002 Italy Single site 1997–1999 None3 − Tx/HD; PD 34/171; 30 44/62; 64 65/63; 63 3/6; 7
American Journal of Transplantation 2011; 11: 2093–2109
McDonald (48) 2002 A Australia; New ANZDATA 1991–2001 10 − CTx/WL HD; PD 2,362/2,782 44/46 [53] 63/58 [53] 89/75 [50]
Document 24-1
Zealand [nWL HD; PD] [5,052]
C.Agnello McDonald (106) 2002 Australia; New ANZDATA 2000 1 Australia; New Tx/HD; PD 1,764 417 − − −
B Zealand Zealand
Piccoli (107) 2002 Italy Regional registry 1995–1999 None nDM Tx;GF/HD; PD 92; 40/56 51; 52/60 59; 73/54 0
Abbott (18) 2001 USA USRDS 1994–1997 21 ESRD-DM Tx/HD; PD 5,683/5,686 47 60 100
Filed 03/11/26
Bakewell (39) 2001 UK Single site 1998 None South Asian; White Tx/HD; PD 40/40; 40 46/53; 49 70/65; 70 10/30; 30
Rebollo (45) 2001 Spain Multiple sites − None <65 years Tx/HD 213/116 49/56 66/58 7/10
Schmidt (24) 2001 Austria Single site 1994–1998 5 PTCA Tx/HD 42/42 59/57 81/76 17/26
Staathof-Galema (79) Netherlands Two sites 1990–1996 7 − CTx; LTx/HD 54/102 50/48 61/63 3/3
SE 0212
2001 409
Choi (32) 2000 South Korea Single site − 0.5 DM; nDM Tx/PD 71/101 59/58 − 30/18
Fujisawa (82) 2000 Japan Two sites − None − CTx; LTx/WL HD 117/49 [65] 44/46 [46] 43/76 [69] 4/4[5]
[nWL HD]
Johnson (44) 2000 Australia Single site 1993–1997 6 >60 years CTx/D 67/107 66/66 49/41 8/20
Rabbat (50) 2000 Canada CORR 1990–1994 6 − CTx/D 722/1,156 44 63/62 18/224
Rebollo (86) 2000 Spain Multiple sites 1996 None − CTx/HD 210/170 51/67 67/51 7/124
Ward (20) 2000 USA USRDS 1987–1994 32 Females: Tx/D 946/3,431 36/40 0 −
ESRD-Lupus
ESRD 5,173/66,202 41/61 1004
ESRD 12,733/100,980 43/62 −
Mazzuchi (53) 1999 Uruguay Multiple sites 1981–1998 10 − Tx/HD 460/695 37/60 67/63 7/17
Wolfe (62) 1999 USA USRDS 1991–1996 7 − CTx/D 23,275/22,889 40–59/40–592 63/58 31/354
Lim (73) 1998 Malaysia National registry 1992–1995 4 − Tx/HD[Home]; PD 909/1,260; 307 34/42; 46 57/66; 54 9/26; 34
Schnuelle (8) 1998 Germany Regional registry 1989–1997 8 − Tx/HD 144/167 48/44 60/62 5/14
Segoloni (78) 1998 Italy Single site 1992–1996 5 − Tx/WL D 344/916 45/46 60/64 1/24
Spencer (41) 1998 Australia − 1978–1996 18 Indigenous; Tx/D 56/158 45 46 41
nIndigenous
Continued.
Systematic Review of Kidney Transplantation
2097
Page 215 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Table 1: Continued
2098 Maximum
Author Accrual follow-up Sample Mean age Percent Percent
and year Country Source era (years) Population Treatment size (years) male diabetic
Wight (87) 1998 UK Single site 1995 None − Tx/HD; PD; Home; 228/100; 109; 42; 40–49/50–59; 62/56; 57; 69; 10/11; 22; 0;
Tonelli et al.
Sat 41 50–59; 59 204
40–49;
60–692
Bonal (56) 1997 Spain Regional registry 1984–1993 10 − CTx/HD 157/395 62/61 58/62 04
Lui (108) 1997 China Regional registry 1995–1996 1 − CTx; LTx/HD; PD 957/495; 1,885 41/48; 57 57/52; 50 6/11; 24
Ozminkowski (85) USA National registry 1992–1995 None − Tx/D 211/304 45–592 54 294
1997
Boni (63) 1996 Brazil Single site − 3 − CTx; LTx/HD; PD 36/36 33/33 67/61 3/34
Agodoa (109) 1995 USA USRDS 1980–1990 − − CTx; LTx/HD; 9,065/121,987 60–642 622 30
Case 2:24-cr-00366-NJC
Home; Self; PD
Disney (66) 1995 Australia ANZDATA 1983–1992 3 − Tx/HD; PD 4,381/6,635 −/45–642 −/54–602 8–264
Locatelli (61) 1995 Italy Regional registry 1983–1992 − − Tx/HD; PD 1,450/6,823 57 58 3–74
Schaubel (54) 1995 Canada CORR 1987–1993 7 − Tx/D 284/6,116 60–69/60–692 66/58 12/22
Teraoka (110) 1995 Japan Multiple society 1964–2002 9 − CTx; LTx/HD; 6,367/123,926 − − −
registries Home; Night; PD
Cowie (21) 1994 USA Regional registry 1974–1983 9 <65 years: Tx/D 129/117 35 62 100
ESRD-DM1; 50/298 55 49 100
ESRD-DM2
El-Reshaid (111) 1994 Kuwait Multiple sites 1986–1990 5 − CTx; LTx/HD; PD 289/358 452 64 154
Ojo (38) 1994 USA Multiple regional 1984–1989 6 Black CTx/D 236/554 40/40 66/66 25/24
Document 24-1
registries
C.Agnello Pugh (42) 1994 USA Regional registry 1975–1985 − nHispanic White; Tx/HD; Home; PD 649/4,731 50–592 − 224
Mexican-Amercian; 264/2,898 50–59 44
Black 261/3,160 50–59 20
Del Pilar Garofano Spain Multiple sites − None − Tx/HD 45/111 38/54 56/50 0/74 Filed 03/11/26
Plazas (112) 1993
Port (7) 1993 USA Multiple regional 1984–1989 6 <65 years CTx/WL D [nWL D] 799/770 [3,451] − 60 [−]
registries
SE 0213 Brunori (113) 1992 Italy Single site 1981–1990 10 − CTx/HD; PD 228/188; 232 36/53 − −
Alamartine (57) 1991 France Single site 1973–1987 15 − Tx/D 120/158 45 38/51 − 410
Julius (114) 1989 USA Regional registry 1981–1984 None − CTx; LTx/HD; PD 83; 80/171; 125 41–60; 20– 52; 61/49; 54 25; 34/26; 174
40/41–60;
41–602
Kjellstrand (115) 1989 USA Two sites 1963–1985 − − Tx/D 2,579/2,004 − − −
Petrie (116) 1989 New Zealand Single site − None − CTx/HD; PD 30/75 39/43 67/55 −.
Silins (75) 1989 Canada National registry 1981–1986 5 − Tx/D 2,436/5,996 45–642 61 184
Fauchald (67) 1988 Norway Multiple sites 1981–1985 6 − CTx; LTx/WL D 122/127 [119] 66/66 [70] 69 −
[nWL D]
Morris (117) 1988 UK Single site − None − Tx/HD; Home; PD 69/69 49/54 40/34 −
Burton (51) 1987 UK Single site 1974–1985 11 − CTx; LTx/HD; PD 183/276; 158 38/42; 51 64/63; 58 5/4; 124
Churchill (118) 1987 Canada Single site − None3 − Tx/HD; Home; PD 79/42; 42; 31 − − −
Khauli (22) 1986 USA Single site 1976–1982 8 ESRD-DM; DM1 CTx; LTx/D 52/48 34/41 − 100
Khauli (33) 19865 USA Single site 1976–1982 8 DM CTx; LTx/HD; PD 48/52 33/42 − 100
Evans (119) 1985 USA Multiple sites − None − CTx; LTx/HD; 144/347; 287; 81 37/52; 47; 50 48/50; 64; 46 8/10; 8; 16
Home; PD
Garcia-Garcia (58) 1985 USA Single site 1973–1981 9 − CTx; LTx/D 103/238 47 45 28/29
Minetti (120) 1985 Italy − 1972–1985 14 − CTx/HD WL 284/211 − − −
Continued.
American Journal of Transplantation 2011; 11: 2093–2109
Page 216 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Table 1: Continued
Maximum
Author Accrual follow-up Sample Mean age Percent Percent
and year Country Source era (years) Population Treatment size (years) male diabetic
Hellerstedt (121) 1984 USA Multiple sites 1978–1983 6 − CTx; LTx/HD; 1,187/1,999 21–45/46–602 62/55 −
Home; PD
Zimmerman (34) 1984 USA Two sites 1971–1983 − DM CTx; LTx/HD; PD 36; 37/66 37; 31/48 − 100
Krakauer (69) 1983 USA National registry 1977–1980 − − CTx; LTx/D 7,595; 31–40; 63; 60/56 7; 8/94
3,491/65,270 21–30/>502
Kramer (23) 1983 Europe EDTA-ERA 1976–1981 − ESRD-Lupus; Tx; GF/D 120; 48/815 − − −
ESRD-PCKD 1,085; 407/6,293
Vollmer (60) 1983 USA Multiple sites 1960–1979 19 − CTx; LTx/D 255/594 45–542 55 114
Case 2:24-cr-00366-NJC
Cestero (122) 1980 USA Multiple sites 1967–1978 − − Tx/HD; Home 150/299; 109 43–48 − −
Nicholls (123) 1980 UK − 1968–1978 10 − CTx/D 48/50 37 − −
Avram (124) 1979 USA Single site 1973–1978 5 − CTx; LTx/DM D 69/122 [482] − 75/63 [57] 6/100 [0]
[nDM D]
Dumler (125) 1979 USA Single site 1972–1978 6 − CTx: LTx/HD 140/443 40/62 − 0
Hull (126) 1979 USA Single site ≥1970 5 − CTx; LTx/D 248/605 − 56 −
Bonney (127) 1978 USA Multiple sites 1967–1975 8 − CTx/HD; Home 84/328; 41 30/43; 46 − 0/30; 24
Golper (128) 1978 USA Single site 1971–1977 7 >45 years CTx/D 30/51 51/51 − 3
Kreis (71) 1978 France Single site 1962–1976 7 − CTx/HD; Home 272/440; 210 30/<50 − −
Price (74) 1978 Canada Single site 1964–1976 12 − CTx/HD; Home; PD 305 38 67 −
American Journal of Transplantation 2011; 11: 2093–2109
Cantaluppi (76) 1977 Italy Single site ≥1972 5 − CTx; LTx/HD; 66/61 34/37 71/66 −
Document 24-1
Home
C.Agnello Higgins (129) 1977 Canada Single site 1962–1975 − − Tx/HD 87/55 31 62 24
Rao (29) 1977 USA Single site 1972–1976 5 DM CTx; LTx/HD 160/60 35/40 64/57 100
Bonomini (64) 1975 Italy Single site 1966–1974 9 − CTx; LTx/D 39/113 − − −
Krumlovsky (72) 1975 USA Single site 1970–1974 5 − CTx; LTx/HD 85/92 − − −
Filed 03/11/26
Lowrie (130) 1973 USA − 1964–1972 9 − CTx; LPTx; 112; 93; 79/125 38; 24; 36/44 62; 71; 58/73 1; 1; 0/54
LSTx/Home
SE 0214 USA = United States of America; GOV = government; UK = United Kingdom; UKRR = United Kingdom Renal Registry; ERA-EDTA = European Renal Association-European
Dialysis and Transplant Association; USRDS = United States Renal Data System; ANZDATA = Australia and New Zealand Dialysis and Transplant Registry; CORR = Canadian Organ 411
Replacement Register; WL = waitlisted; nWL = not waitlisted; ECD = extended-criteria donor; HBV+ = hepatitus B virus positive; HCV+ = hepatitis C virus positive; Hep– =
hepatitis negative; DM = diabetes mellitus; nDM = no diabetes mellitus; PTCA = percutaneous transluminal coronary angioplasty; CABG = coronary artery bypass graft; nECD =
not expanded criteria donor; HCV+ donor = hepatitis C virus donor; HCV– donor = hepatitis C virus negative donor; HCV– = hepatitus C virus negative; ESRD-DM = end-stage
renal disease caused by diabetes mellitus; DM1 = diabetes mellitus type 1; nObese = not obese; nIndigenous = non-indigenous; ATSI = aboriginal and Torres strait islander;
ESRD-Lupus end-stage renal disease caused by lupus; ESRD-Other = end-stage renal disease caused by something other than diabetes mellitus or lupus; ESRD-DM2 = end-stage
renal disease caused by diabetes mellitus type 2; nHispanic = non-Hispanic; ESRD-PCKD = end-stage renal disease caused by polycystic kidney disease; CTx = cadaveric donor
transplantation; LTx = living donor transplantation; HD = hemodiaylsis; PD = peritoneal dialysis; Tx = trasnplantation; GF = graft failure dialysis; Home = home hemodialysis; Self =
self hemodialysis; Sat = dialysis at a satellite unit; Night = nocturnal hemodialysis; D = dialysis; LPTx = living parent donor transplantation; LSTx = living sibling donor transplantation.
The studies are sorted by year and the first author’s last name.
1 Mean.
2 Median.
3 There was a second interview.
4 Cause of end-stage renal disease.
5 This study used the same transplantation group as the other Khauli 1986 study.
6 Quality-of-life studies were not excluded if they had cross-sectional designs.
Systematic Review of Kidney Transplantation
2099
Page 217 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 218 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
412
Tonelli et al.
Study design?
Waitlisted?
Contemparaneous groups?
Population described?
Model adjustment?
0 20 40 60 80 100
percent
Prospective/Yes
Registry/Unclear/Partial
Retrospective/No
Figure 2: Risk of bias of included studies. The responses for each question in this risk of bias tool are represented by different colors,
segmented along a horizontal bar. Light gray depicts the percent of studies responding with the smallest risk of bias. Medium gray depicts
the percent of studies responding with the greatest risk of bias. Dark gray indicates a moderate or unclear risk of bias. The responses to
“Study design?” are prospective, registry and retrospective. The responses to “Waitlisted?” and “Contemporaneous groups?” are yes,
unclear and no. The responses to “Population described?” and “Model adjustment?” are yes, partial and no.
after transplantation (five studies reported a time period respectively). However, given the small number of stud-
of <30 days and one <3 months [48]), mortality tended to ies, no firm conclusions can be drawn from these results.
be significantly greater in transplant recipients (HR range
0.9–5.03). These studies also reported the relative haz-
ard of mortality at 1 year after transplantation, which in all Evidence of effect modification for mortality
cases, was significantly lower among transplant recipients In multivariable meta-regression of 20 studies (13,27,51–
(HR range 0.19–0.49). 55,63–74; 865 208 participants), we found that the unad-
justed relative risk of mortality associated with transplan-
Thirty-eight cohorts (8,15,17,19,21,30,31,35,37,42–44,51– tation (compared with dialysis) was lower in more recently
61; 23 studies; 904 610 participants) reported adjusted performed studies (p < 0.001; Figure 4, panel A). Results
relative hazards, rates or odds for mortality during total were similar when a subset of 10 studies (7,19,46,56,76–
follow-up after transplantation (maximum follow up ranged 79), including only 97 873 dialysis patients who had been
6–19 years; Figure 3). Seventy-nine percent of these placed on the transplant waiting list, were considered
results significantly favored lower mortality in the trans- (p = 0.12; Figure 4, panel B). Variables assessing risk
plantation groups (HR range 0.16–0.76) and 21% were of bias (i.e. study design [prospective, registry, etc.], ad-
nonsignificant (HR range 0.33–1.12). These studies also equate description of population, prevalent vs. incident pa-
included perioperative deaths, and thus, demonstrate that tients, censoring at modality switch and funding) were not
the higher short-term risk of death associated with kid- significantly associated with the benefit of transplantation
ney transplantation is more than offset by the lower risk in meta-regression. Other variables were not tested as
of mortality during subsequent follow up. In the subset of they were not relevant to the unadjusted mortality results
studies including only waitlisted participants (10 studies; (e.g. outcome definitions, adjusted model) or they did not
474 522 participants), 94% of comparisons significantly fa- sufficiently differ in value (e.g. contemporaneous groups).
vored lower mortality for transplant recipients (15 of 16
comparisons; HR range 0.16–0.73). Limited information was available on characteristics mod-
ifying the association between transplantation and mor-
Three studies (35,58,60) reported relative hazards sepa- tality. One study (60) tested whether age, the number of
rately for living donor transplantation and for deceased associated diseases and dialysis vintage affected the asso-
donor transplantation, and found that the relative hazards ciation between transplantation and mortality, but found no
of transplantation, compared to dialysis, tended to be lower significant evidence of effect modification. Another study
for analyses of living donors (HR 0.23, 0.33 and 0.55) than (61) also tested the association between age and the mor-
for analyses of deceased donors (0.39, 1.12 and 1.01, tality benefit of transplantation, but found no significant
2100 American Journal of Transplantation 2011; 11: 2093–2109
C.Agnello SE 0215
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 219 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
413
Systematic Review of Kidney Transplantation
0.1 0.5 1 2 10
Study ID Adj HR (95% CI)
< 30 days
Transplant vs Dialysis
Oniscu 2005* 0.91 (0.22, 3.70)
Oniscu 2004* 5.03 (1.43, 17.73)
McDonald 2002* † 2.00 (1.50, 2.70)
Rabbat 2000* 2.91 (1.34, 6.32)
Ojo 1994* 3.30 P0 0.03
Port 1993* 2.43 P0 0.01
> 1 year
Transplant vs Dialysis
Oniscu 2005* 0.28 (0.20, 0.39)
Oniscu 2004* 0.27 (0.14, 0.52)
McDonald 2002* 0.19 (0.15, 0.24)
Rabbat 2000* 0.25 (0.14, 0.42)
Ojo 1994* 0.49 P0 0.03
Port 1993* 0.36 P0 0.001
Full follow-up
Transplant vs Dialysis
Bayat 2010 60 y 0.23 (0.13, 0.42)
Bayat 2010 60 y 0.22 (0.10, 0.45)
Jain 2009 0.20 (0.11, 0.34)
Sorensen 2007 nDM 0.40 (0.30, 0.55)
Sorensen 2007 DM 0.21 (0.13, 0.34)
Snyder 2006 nDM/nPAD* 0.73 (0.68, 0.79)
Snyder 2006 DM/nPAD* 0.57 (0.52, 0.62)
Snyder 2006 nDM/PAD* 0.47 (0.40, 0.56)
Snyder 2006 DM/PAD* 0.36 (0.31, 0.41)
Merion 2005 ECD* 0.40 (0.37, 0.44)
Merion 2005* 0.28 (0.27, 0.30)
Abbott 2004 HCV+donor 0.76 (0.60, 0.96)
Abbott 2004 HCV-donor 0.47 (0.44, 0.50)
Brunkhorst 2003* 0.29 (0.12, 0.70)
Glanton 2003 nObese* 0.39 (0.35, 0.43)
Glanton 2003 Obese* 0.39 (0.33, 0.47)
0.1 0.5 1 2 10
Fav ours Transplant Fav ours Dialy sis
Figure 3: Adjusted ratio of all-cause mortality by time period. ∗ Indicate waitlisted dialysis groups. † 0–3 months of follow-up. Tx =
transplant; D = dialysis; nDM = no diabetes mellitus; DM2 = type 2 diabetes mellitus; HepCdonor = hepatitis C donor; nDM/nPAD =
no diabetes mellitus/no peripheral arterial disease; DM/nPAD = diabetes mellitus/no peripheral arterial disease; DM1 = type 1 diabetes
mellitus; nDM/PAD = no diabetes mellitus/peripheral arterial disease; HCV + donor = hepatitis C donor; HCV – donor = hepatitis C negative
donor; nDM = no diabetes mellitus; ECD = extended criteria donor; nObese = not obese; DM/PAD = diabetes mellitus/peripheral arterial
disease; DM = diabetes mellitus; Adj HR = adjusted hazard ratio; Adj OR = adjusted odds ratio; CI = confidence interval; NS = not
significant; ESRD = end-stage renal disease; RRT = renal replacement therapy. Oniscu 2005 adjusted for age, gender, ESRD cause, social
deprivation, time on RRT and comorbidities. Oniscu 2004 adjusted for age, gender, ESRD cause, social deprivation, dialysis modality
and distance to center. MacDonald 2002 adjusted for age and comorbidities. Rabbat 2000 adjusted for age, gender, race, time on RRT
and ESRD cause. Ojo 1994 adjusted for age, gender and ESRD cause. Port 1993 adjusted for age, gender, race, ESRD cause and era.
Bayat 2010 adjusted for age, BMI, comorbidities, albumin and urgent first dialysis session. Jain 2009 adjusted for age, race, ESRD cause,
comorbidities, dialysis modality and time on RRT. Pauly 2009 adjusted for age, gender, comorbidities, era; matched on race, DM and
time on RRT. Sorenson 2007 adjusted for age, gender and era. Synder 2006 adjusted for age, gender, race, ethnicity, BMI, ESRD cause,
comorbidities and time on RRT. Merion 2005 adjusted for age, gender, race, ethnicity, blood type, ESRD cause, comorbidities at waitlist,
era, panel reactive antibody values, dialysis modality, time from first RRT to waitlist and donation service area for the organ procurement
organization. Abbott 2004 adjusted for age, race, BMI, smoking, ESRD cause, comorbidities, era, albumin and access complications.
Brunkhorst 2003 matched for age, gender, era, time on RRT and time with DM. Glanton 2003 adjusted for age, race, BMI, cause of
ESRD, comorbidities, era and albumin. Johnson 2000 adjusted for time on RRT. Mazzuchi 1999 adjusted for age, gender, alcoholism and
comorbidities. Wolfe 1999 adjusted for age, sex, race, ESRD cause, era and time from first RRT to waitlist. Schnuelle 1998 adjusted for
age, gender, BMI, comorbidities, residual urine volume, number of previous transplants performed and time on RRT. Bonal 1997 adjusted
age, gender and comorbidities. Schaubel 1995 matched on age, ESRD cause and number of comorbidities. Cowie 1994 adjusted for age,
gender, weight, era, comorbidities and blood pressure. Pugh 1994 adjusted for age, race, ESRD cause and center size. Garcia-Garcia
1985 adjusted for age, gender, race, ESRD cause, comorbidities, era, age of DM onset, insurance and age at transplantation. Vollmer
1983 adjusted for age, number of comorbidities and era. Burton 1987 did not report what they adjusted for. Chavers 2007 adjusted for
age, gender, race, era, ESRD cause and time on RRT. Zimmerman 2006 adjusted for age and gender.
American Journal of Transplantation 2011; 11: 2093–2109 2101
C.Agnello SE 0216
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 220 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
414
Tonelli et al.
0.1 0.5 1 2 10
Study ID Adj HR (95% CI)
Full follow-up
Tranplant vs Dialysis
Johnson 2000* 0.16 (0.06, 0.42)
Mazzuchi 1999 nDM 0.97 (0.61, 1.52)
Mazzuchi 1999 DM 0.35 (0.15, 0.83)
Wolfe 1999* 0.32 (0.30, 0.35)
Schnuelle 1998* 0.37 (0.14, 0.97)
Bonal 1997* 0.51 P=0.02
Schaubel 1995 0.47 (0.33, 0.67)
Cowie 1994 DM2 0.89 (0.60, 1.34)
Cowie 1994 DM1 0.50 (0.36, 0.70)
Pugh 1994 0.37 P<0.001
Alamartine 1991 0.52 P=NS
Burton 1987 1.09 P=NS
Garcia-Garcia 1985 1.12 P=NS
Vollmer 1983 1.01 (0.59, 1.73)
Tranplant vs Home dialysis
Pauly 2009* 0.87 (0.50, 1.51)
Living donor transplant vs Dialysis
Glanton 2003 Obese* 0.23 (0.16, 0.34)
Garcia-Garcia 1985 0.33 P=NS
Vollmer 1983 0.55 (0.32, 0.93)
Living donor transplant vs Home dialysis
Pauly 2009* 0.51 (0.28, 0.91)
Adj Rate Ratio (95% CI)
Transplant vs Dialysis
Chavers 2007 0.25 (0.23, 0.27)
Transplant vs Peritoneal dialysis
Chavers 2007 0.33 (0.30, 0.36)
Adj OR (95% CI)
Transplant vs Dialysis
Zimmerman 2006 0.20 (0.07, 0.59)
0.1 0.5 1 2 10
Fav ours Transplant Fav ours Dialy sis Figure 3: Continued.
effect modification. A third study (31) found that the re- tude of the mortality reduction associated with trans-
duction in mortality associated with transplantation was plantation. However, the benefits of transplantation
greater among patients with peripheral arterial disease seemed less pronounced in the subset of studies that
than in those without. We found no evidence that the as- were restricted to patients who were waitlisted for
sociation between transplantation and mortality was mod- transplantation.
ified by dialytic modality.
Meta-regression did not identify factors that significantly
Overall, there was no consistent association be- modified the association between transplantation and clin-
tween markers of study risk of bias and the magni- ical outcomes other than mortality.
Figure 4: Meta-regression line for year of study publica-
5 5 tion and mortality risk ratio associated with transplan-
tation, compared with dialysis patients. The mortality
risk ratio is plotted against the year of study publication.
2 2
Circles are the observed estimates; size is based on the
Mortality RR
inverse of the standard error of each study. The three lines
1 1
are the fitted and the upper and lower bounds of the 95%
confidence intervals. Panel (A) compares transplant patients
0.5 0.5 with dialysis patients who may or may not have been active
on the transplant waiting list and panel (B) compares trans-
plant patients with dialysis patients who had been placed on
0.2 0.2
the transplant waiting list. The era of study publication was
significantly associated with the risk of mortality associated
0.1 0.1
with transplantation, indicating that the relative magnitude
1970 1980 1990 2000 2010 1970 1980 1990 2000 2010
of the benefit increased over time (panel A, p < 0.001). A
Era Era similar trend was shown in Panel B (p = 0.12). RR, risk ratio.
2102 American Journal of Transplantation 2011; 11: 2093–2109
C.Agnello SE 0217
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 221 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
415
Systematic Review of Kidney Transplantation
Ratio
Any cardiac event
Heart failure
Figure 5: Ratios of cardiac events and hospitaliza-
tions among transplant recipients, compared to
dialysis patients. The small solid diamonds repre- Ischemic heart disease
sent the ratios (risk, hazard, rate) of cardiac events
and hospitalizations between transplant patients and
either hemodialysis and/or peritoneal dialysis patients Myocardial infarction
(for each individual study). The black-colored diamonds
are adjusted ratios; the gray-colored diamonds are un-
Any hospitalization
adjusted ratios. The shaded gray region denotes values
between 0.80 and 1.25. Data points outside the gray
region represent large differences between transplant Hospitalization - infection
patients and dialysis patients (ratio ≥ 20% reduction
or improvement). Some studies contributed more than 0.1 0.2 0.4 0.8 1.25 2.5
one cohort (datapoint) to analyses. Favours Transplant Favours Dialysis
Cardiovascular events and hospitalization for unadjusted and adjusted analyses comparing QoL as-
In unadjusted analyses, four of six cohorts (19,20,25,33; sessed using other instruments including EQ-5D, Karnof-
four studies; 189 769 participants) found that transplanta- sky Performance Index, SIP, GHQ, WHO-QoL, 15D and TTO
tion significantly reduced the risk of myocardial infarction; (data not shown).
two of five cohorts (19,20,56; three studies; 190 109 partic-
ipants) found that transplantation significantly reduced the
risk of stroke and two further studies found that transplan-
Discussion
tation significantly reduced the risk of heart failure (11 369
participants [18]) and the incidence of ischemic heart dis-
In this systematic review of 110 studies including a to-
ease (552 participants [56]). Only two studies reported ad-
tal of 1 961 904 participants with kidney failure, kidney
justed analyses for cardiac events. One (19; 92 participants)
transplantation was associated with reduced risk of mor-
found that transplantation from a deceased donor signifi-
tality and cardiovascular events as well as better QoL
cantly reduced the rate of cardiac events by 76% (relative
than treatment with chronic dialysis. Results were con-
rate 0.24, 95% CI: 0.07–0.81) and the other (18; 11 369
sistent for different dialysis modalities, for transplanta-
participants) found no association between transplantation
tion from both deceased and living donors and across
and heart failure. The risk of infection-related hospitaliza-
countries with differing health care systems. These re-
tion seemed to be significantly decreased among trans-
sults confirm that kidney transplantation is the preferred
plant recipients, with both cohorts (one study; 336 986
modality of treatment for chronic kidney failure, and justi-
participants) favoring transplantation. Results for all-cause
fies current attempts to increase the number of patients
hospitalization were more equivocal, with only 5 of 10 co-
worldwide who benefit from kidney transplantation—by
horts (six studies; 354 256 participants) significantly favor-
increasing rates of deceased and living kidney donation,
ing transplantation. Results of these analyses are summa-
expanding the pool of potential donors and recipients and
rized in Figure 5.
reducing the likelihood that potentially viable organs are
discarded.
Quality of life
In unadjusted analyses comparing QoL using the SF-36 be- As expected, mortality among transplant recipients in-
tween transplant recipients and dialysis patients, 47–100% creased sharply as compared with those remaining on
of cohorts (55,80–87; depending on the domain consid- dialysis during the perioperative period (62). Thereafter,
ered), significantly favored the transplantation groups and mortality among transplant recipients significantly declined
none significantly favored the dialysis groups. Three co- such that cumulative mortality associated with transplan-
horts (80,88; two studies; 497 participants) reported the tation was significantly lower than among patients treated
adjusted association between transplantation and SF-36 with dialysis (62,89). Contemporary dialysis patients have
scores as compared with dialysis. The vast majority of anal- more comorbidity and must wait longer for transplanta-
yses significantly favored transplantation over hemodial- tion than patients awaiting kidney transplantation in pre-
ysis. One small cohort (80; 64 participants) comparing vious years (6). Despite this, our results suggest that
transplantation to peritoneal dialysis was not significantly the relative benefit of transplantation may have signifi-
different for any of the domains reported. These findings cantly increased over time, compared to remaining on dial-
are summarized in Figure 6. Results were broadly similar ysis. For example, the unadjusted relative risk of mortality
American Journal of Transplantation 2011; 11: 2093–2109 2103
C.Agnello SE 0218
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 222 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
416
Tonelli et al.
MD
Physical functioning
Figure 6: Mean differences in domains of the short
Role - physical form health survey (SF-36) among transplant re-
Bodily pain
cipients, compared to dialysis patients. The small
solid gray diamonds represent the mean difference in
Mental health SF-36 domains between transplant patients and either
hemodialysis and/or peritoneal dialysis patients (for each
Role - emotional
individual study). The black-colored diamonds are ad-
Social functioning justed mean differences; the gray-colored diamonds are
unadjusted mean differences. The shaded gray region
Vitality denotes the minimal clinical important difference for SF-
General health 36 domains; Samsa et al. (131) found that a difference
between 3 and 5 was clinically important. Data points
Physical summary outside the gray region represent large differences be-
tween transplant patients and dialysis patients (mean
Mental summary
difference ≥5). Some studies contributed more than one
-30 -20 -10 0 10 20 30 40 50 60 cohort (datapoint) to analyses. SF-36, short form health
Favours Dialysis Favours Transplant survey-36 items; MD, mean difference.
associated with transplantation (compared with dialysis) were at lower risk of all-cause hospitalization than dialysis
decreased from 0.44 in 1985 to 0.17 in 2005. This find- patients, perhaps because allograft recipients require hos-
ing may relate to use of more potent immunosuppression, pitalization for transplantation itself as well as any surgical
better management of comorbid medical conditions, more complications.
careful selection of transplant recipients or perhaps, to
highe mortality in more recent years among the compara- We found consistent and clinically relevant improvements
tor pool of patients remaining on dialysis (89–91). How- in QoL associated with kidney transplantation (78,86,92).
ever, because our study did not identify the explanation These results were consistent across a variety of settings,
for this finding, these suggestions are speculative. Alter- were preserved in adjusted analyses, and were observed
natively, because the apparently greater benefit of trans- for a broad range of QoL instruments (78,86,92,93). Be-
plantation in more recent years was based on unadjusted cause markedly reduced QoL is a hallmark of kidney fail-
analyses, it is possible that confounding by comorbidity or ure, these improvements may be the most important ben-
other characteristics wholly or partially explains this find- efit of kidney transplantation, compared with remaining on
ing. Finally, we used the median year of each study’s ac- dialysis.
crual period as a proxy for era of transplantation—which
may have led to the ecological fallacy. Therefore, although Although one of the major objectives of our study was
appealing, our conclusion that the relative benefit of trans- to examine factors that modified the clinical benefits
plantation has increased over time should be viewed with of transplantation (as compared to dialysis), we identi-
caution. fied few data addressing this objective. However, find-
ings from a single study (with 96 736 participants)
Immunosuppressive medications used in transplant recipi- suggested that the mortality reduction associated with
ents may cause anemia, hypertension, glucose intolerance transplantation was more pronounced in patients with pe-
and dyslipidemia (91). Despite this, in analyses based on a ripheral arterial disease. Meta-regression was unhelpful for
total of 10 studies (333 881 patients), we found that trans- identifying factors that modified the association between
plantation was associated with significantly lower risk of transplantation and outcomes other than mortality.
cardiovascular events compared to treatment with dialysis
(18–20,25,33,56). Although this finding might be partially To our knowledge, this is the most comprehensive and
because of selection of healthier patients for transplan- up-to-date summary of the potential benefits of kidney
tation, results were similar in analyses restricted to dial- transplantation, as compared with dialysis. We used a
ysis patients who were active on the transplant waiting carefully designed literature search and rigorous meth-
list—which should minimize the effect of such bias. Al- ods to capture and synthesize the results of 110 studies,
though immunosuppressive medications can predispose published over a period of more than four decades. Our
to infection, our results suggest that transplantation is as- results clearly illustrate the clinical benefits of kidney trans-
sociated with reduced risk of hospitalization for infection— plantation. Together with the dismal outcomes associated
emphasizing the high risk of sepsis associated with vas- with dialysis and the dramatic worldwide increases in pro-
cular and peritoneal access required to perform dialysis. jected waiting times for kidney transplantation among pa-
We did not find clear evidence that transplant recipients tients with kidney failure, these findings emphasize the
2104 American Journal of Transplantation 2011; 11: 2093–2109
C.Agnello SE 0219
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 223 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
417
Systematic Review of Kidney Transplantation
urgent need to increase rates of deceased and living kidney spite increases in the age and comorbidity of contempo-
donation (94). rary transplant recipients, the relative benefits of trans-
plantation (as compared to remaining on dialysis) seem
As with all systematic reviews, the strength of our con- to be increasing over time. Given the current organ short-
clusions is dependent on the analysis of aggregate (study- age, these findings validate current attempts to increase
level) data and the quality and availability of studies. In addi- the number of people worldwide that benefit from kidney
tion to assessing studies for bias using items from Downs transplantation.
and Black (11), we added specific items of bias pertinent
to our question. Second, we found a significant increase in
the benefit of kidney transplantation over time, perhaps be- Acknowledgments
cause of improvements in the care of transplant recipients.
Unfortunately, despite our best efforts, we were unable to The authors sincerely thank Ellen Crumley for librarian support, Ghenette
identify patient-level or study-level factors that were asso- Houston for administrative support, Mohammad Karkhaneh, Natasha Krahn
and Sophanny Tiv for additional reviewer support.
ciated with greater or lesser benefit from transplantation.
Third, although we sought to determine a summary esti-
Funding source: This study was funded by the Canadian Institutes of Health
mate of the benefit of kidney transplantation for clinically
Research. Drs. Tonelli and Klarenbach were supported by salary awards from
relevant outcomes, there was substantial heterogeneity in the Alberta Heritage Foundation for Medical Research. Dr. Tonelli was also
all pooled analyses (I2 ≥ 97%), making the validity of meta- supported by a Government of Canada Research Chair in the optimal care
analysis questionable. Despite use of meta-regression, we of people with chronic kidney disease. Drs. Tonelli and Klarenbach were
were unable to explain the source of this heterogeneity— supported by a joint initiative between Alberta Health and Wellness and the
which may be because of the wide range of renal replace- Universities of Alberta and Calgary. Dr. Gill was supported by a salary award
ment modalities we included, to the observational nature from the Michael Smith Foundation. Dr. Knoll is supported by a University
of the various studies, to the ecological fallacy (95) or to the of Ottawa Chair in Clinical Transplantation Research.
fact that some (but not all) studies included dialysis patients
who were not eligible for transplantation (selection bias). Authors’ contributions
However, the magnitude and consistency of the benefit M.T., G.K., S.K., J.G. and Ms. N.W. contributed to the de-
associated with transplantation across analyses leave little sign of the study. N.W. performed the statistical analyses
doubt that transplantation is beneficial as compared with and managed the project. M.T. wrote the first draft of the
dialysis, even if this benefit cannot be easily conveyed in a manuscript. All authors contributed to data acquisition, the
single summary measure. Finally, because multiple stud- interpretation of results and critical revision of the article
ies from certain countries were captured by our search, it for intellectually important content.
is possible that a small minority of patients were included
in more than one study. Because we did not statistically
pool results across studies and because results were con- Disclosure
sistent for all analyses, this is unlikely to have affected our
The authors of this manuscript have no conflicts of inter-
results.
est to disclose as described by the American Journal of
Transplantation.
Given the scarcity of renal allografts, future studies should
explicitly seek to identify patient-level factors associated
with the benefit of transplantation for outcomes other
References
than mortality. For some outcomes (such as cardiovascular
1. Levey AS, Atkins R, Coresh J, et al. Chronic kidney disease as a
events or all-cause hospitalization), this could be achieved
global public health problem: Approaches and initiatives—A posi-
by patient-level meta-analysis (perhaps of registry data
tion statement from kidney disease improving global outcomes.
from different countries), which would increase statisti- Kidney Int 2007; 72: 247–259.
cal power and also reduce the risk of the ecological fal- 2. Suthanthiran M, Strom TB. Renal transplantation. N Engl J Med
lacy. Other outcomes (such as QoL) will require detailed 1994; 331: 365–376.
prospective study, perhaps in conjunction with data col- 3. Wolfe RA, Roys EC, Merion RM. Trends in organ donation and
lected to determine candidacy for transplantation. Because transplantation in the United States, 1999–2008. Am J Transplant
statistical adjustment for potential confounders will be crit- 2010; 10(4 Pt 2): 961–972.
ical for the success of such initiatives, consensus on the 4. United States Renal Data System (USRDS). [cited 10 March
best way to measure and adjust for comorbidity, accruing 2011]. Available at: http://www.usrds.org/2008/view/esrd_07.asp
5. Mathur AK, Ashby VB, Sands RL, Wolfe RA. Geographic variation
after wait-listing for transplantation, would be an important
in end-stage renal disease incidence and access to deceased
next step.
donor kidney transplantation. Am J Transplant 2010; 10 (4 Pt 2):
1069–1080.
In summary, we found that (as compared with dialysis), 6. Himmelfarb J, Ikizler TA. Hemodialysis. N Engl J Med 2010; 363:
kidney transplantation is associated with substantial re- 1833–1845.
ductions in the risk of mortality and cardiovascular events, 7. Port FK, Wolfe RA, Mauger EA, Berling DP, Jiang K. Comparison
as well as clinically relevant improvements in QoL. De- of survival probabilities for dialysis patients vs cadaveric renal
American Journal of Transplantation 2011; 11: 2093–2109 2105
C.Agnello SE 0220
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 224 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
418
Tonelli et al.
transplant recipients [see comment]. JAMA 1993; 270: 1339– 25. Borentain M, Le Feuvre C, Helft G, et al. Long-term outcome
1343. after coronary angioplasty in renal transplant and hemodialysis
8. Schnuelle P, Lorenz D, Trede M, Van Der Woude FJ. patients. J Interv Cardiol 2005; 18: 331–337.
Impact of renal cadaveric transplantation on survival in 26. Massad MG, Kpodonu J, Lee J, et al. Outcome of coronary artery
end-stage renal failure: Evidence for reduced mortality risk com- bypass operations in patients with renal insufficiency with and
pared with hemodialysis during long-term follow-up. J Am Soc without renal transplantation. Chest 2005; 128: 855–862.
Nephrol 1998; 9: 2135–2141. 27. Chauveau P, Couzi L, Vendrely B, et al. Long-term outcome on
9. Waitlist and Transplant Activity for Liver (Kidney, Heart, and Lung renal replacement therapy in patients who previously received
also in full set of slides) 1999–2008 [cited 10 March 2011]. Avail- a keto acid-supplemented very-low-protein diet. Am J Clin Nutr
able at: http://www.ustransplant.org/fastfacts.aspx 2009; 90: 969–974.
10. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observa- 28. Jacobs C, Brunner FP, Brynger H, et al. Malignant diseases in
tional studies in epidemiology: A proposal for reporting. Meta- patients treated by dialysis and transplantation in Europe. Trans-
analysis Of Observational Studies in Epidemiology (MOOSE) plant Proc 1981; 13(1 Pt 2): 729–732.
group. JAMA 2000; 283: 2008–2012. 29. Rao KV, Sutherland D, Kjellstrand CM, Najarian JS, Shapiro FL.
11. Downs SH, Black N. The feasibility of creating a checklist for the Comparative results between dialysis and transplantation in dia-
assessment of the methodological quality both of randomised betic patients. Trans Am Soc Artif Intern Organs 1977; 23: 427–
and non-randomised studies of health care interventions. J Epi- 432.
demiol Community Health 1998; 52: 377–384. 30. Sorensen VR, Mathiesen ER, Heaf J, Feldt-Rasmussen B. Im-
12. Song F, Eastwood AJ, Gilbody S, Duley L, Sutton AJ. Publication proved survival rate in patients with diabetes and end-stage renal
and related biases. Health Technol Assess 2000; 4: 1–115. disease in Denmark. Diabetologia 2007; 50: 922–929.
13. Sezer S, Ozdemir FN, Akcay A, Arat Z, Boyacioglu S, Haberal 31. Snyder JJ, Kasiske BL, Maclean R. Peripheral arterial disease and
M. Renal transplantation offers a better survival in HCV-infected renal transplantation. J Am Soc Nephrol 2006; 17: 2056–2068.
ESRD patients. Clin Transplant 2004; 18: 619–623. 32. Choi KH, Kim SI, Shin SK, et al. Renal replacement therapies
14. Visnja L, Milan S, Jelena M, Vanja R, Ljubica D. Hepatitis B and in the elderly: Renal transplantation and continuous ambulatory
hepatitis C virus infection and outcome of hemodialysis and kid- peritoneal dialysis. Transplant Proc 2000; 32: 1814.
ney transplant patients. Ren Fail 2008; 30: 81–87. 33. Khauli RB, Novick AC, Steinmuller DR, et al. Comparison of renal
15. Abbott KC, Lentine KL, Bucci JR, Agodoa LY, Peters TG, Schnitzler transplantation and dialysis in rehabilitation of diabetic end-stage
MA. The impact of transplantation with deceased donor hepatitis renal disease patients. Urology 1986; 27: 521–525.
C-positive kidneys on survival in wait-listed long-term dialysis 34. Zimmerman SW, Glass N, Sollinger H, Miller D, Belzer F. Treat-
patients. Am J Transplant 2004; 4: 2032–2037. ment of end-stage diabetic nephropathy: Over a decade of expe-
16. Martin Navarro J, Ortega M, Gutierrez MJ, et al. Survival of pa- rience at one institution. Medicine (Baltimore) 1984; 63: 311–317.
tients older than 60 years with kidneys transplanted from Spanish 35. Glanton CW, Kao T-C, Cruess D, Agodoa LYC, Abbott KC. Impact
expanded criteria donors versus patients continued on hemodial- of renal transplantation on survival in end-stage renal disease
ysis. Transplant Proc 2009; 41: 2376–2378. patients with elevated body mass index. Kidney Int 2003; 63:
17. Merion RM, Ashby VB, Wolfe RA, et al. Deceased-donor charac- 647–653.
teristics and the survival benefit of kidney transplantation. [see 36. Blake C, Codd MB, Cassidy A, O’Meara YM. Physical function,
comment]. JAMA 2005; 294: 2726–2733. employment and quality of life in end-stage renal disease. J
18. Abbott KC, Hypolite IO, Hshieh P, et al. The impact of renal Nephrol 2000; 13: 142–149.
transplantation on the incidence of congestive heart failure in 37. Jain P, Cockwell P, Little J, et al. Survival and transplantation
patients with end-stage renal disease due to diabetes. J Nephrol in end-stage renal disease: A prospective study of a multiethnic
2001; 14: 369–376. population. Nephrol Dial Transplant 2009; 24: 3840–3846.
19. Brunkhorst R, Lufft V, Dannenberg B, Kliem V, Tusch G, Pichlmayr 38. Ojo AO, Port FK, Wolfe RA, Mauger EA, Williams L, Berling
R. Improved survival in patients with type 1 diabetes mellitus DP. Comparative mortality risks of chronic dialysis and cadaveric
after renal transplantation compared with hemodialysis: A case- transplantation in black end-stage renal disease patients. Am J
control study. Transplantation 2003; 76: 115–119. Kidney Dis 1994; 24: 59–64.
20. Ward MM. Cardiovascular and cerebrovascular morbidity and 39. Bakewell AB, Higgins RM, Edmunds ME. Does ethnicity influ-
mortality among women with end-stage renal disease at- ence perceived quality of life of patients on dialysis and following
tributable to lupus nephritis. Am J Kidney Dis 2000; 36: 516– renal transplant? Nephrol Dial Transplant 2001; 16: 1395–1401.
525. 40. McDonald SP, Russ GR. Current incidence, treatment patterns
21. Cowie CC, Port FK, Rust KF, Harris MI. Differences in survival and outcome of end-stage renal disease among indigenous
between black and white patients with diabetic end-stage renal groups in Australia and New Zealand. Nephrology 2003; 8:42–
disease. Diabetes Care 1994; 17: 681–687. 48.
22. Khauli RB, Steinmuller DR, Novick AC, et al. A critical look at 41. Spencer JL, Silva DT, Snelling P, Hoy WE. An epidemic of renal
survival of diabetics with end-stage renal disease. Transplan- failure among Australian Aboriginals. Med J Aust 1998; 168: 537–
tation versus dialysis therapy. Transplantation 1986; 41: 598– 541.
602. 42. Pugh JA, Tuley MR, Basu S. Survival among Mexican-Americans,
23. Kramer P, Broyer M, Brunner FP, et al. Combined report on regu- non-Hispanic whites, and African-Americans with end-stage re-
lar dialysis and transplantation in Europe, XII, 1981. Proc Eur Dial nal disease: The emergence of a minority pattern of increased
Transplant Assoc 1983; 19: 4–59. incidence and prolonged survival. Am J Kidney Dis 1994; 23:
24. Schmidt A, Stefenelli T, Schuster E, Mayer G. Informational contri- 803–807.
bution of noninvasive screening tests for coronary artery disease 43. Bayat S, Kessler M, Brianon S, Frimat L. Survival of transplanted
in patients on chronic renal replacement therapy. Am J Kidney and dialysed patients in a French region with focus on outcomes
Dis 2001; 37: 56–63. in the elderly. Nephrol Dial Transplant 2010; 25: 292–300.
2106 American Journal of Transplantation 2011; 11: 2093–2109
C.Agnello SE 0221
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 225 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
419
Systematic Review of Kidney Transplantation
44. Johnson DW, Herzig K, Purdie D, et al. A comparison of the 62. Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in
effects of dialysis and renal transplantation on the survival of all patients on dialysis, patients on dialysis awaiting transplanta-
older uremic patients. Transplantation 2000; 69: 794–799. tion, and recipients of a first cadaveric transplant. [see comment].
45. Rebollo P, Ortega F, Baltar JM, Alvarez-Ude F, Alvarez Navascues N Engl J Med 1999; 341: 1725–1730.
R, Alvarez-Grande J. Is the loss of health-related quality of life 63. Boni RC, Soares VA, Caramori JC, Balbi AL, Correa LA, Carvalho
during renal replacement therapy lower in elderly patients than in MF. Comparative study of infection in renal allograft recipients
younger patients? Nephrol Dial Transplant 2001; 16: 1675–1680. and patients in regular dialysis treatment. Transplant Proc 1996;
46. Oniscu GC, Brown H, Forsythe JLR. How great is the survival 28: 3376.
advantage of transplantation over dialysis in elderly patients? 64. Bonomini V, Vangelista A, Albertazzi A, Stefoni S. Survival and
Nephrol Dial Transplant 2004; 19: 945–951. ‘true’ rehabilitation after dialysis and transplantation: A 7-year
47. Macrae J, Friedman AL, Friedman EA, Eggers P. Live and de- follow-up. Proc Eur Dial Transplant Assoc 1975; 11: 256–260.
ceased donor kidney transplantation in patients aged 75 years 65. Buturovic-Ponikvar J. Slovenian renal replacement therapy reg-
and older in the United States. Int Urol Nephrol 2005; 37: 641– istry G. Slovenian renal replacement therapy registry: Excerpts
648. from the 2006 annual report. Ther Apher Dial 2009; 13: 258–
48. McDonald SP, Russ GR. Survival of recipients of cadaveric kidney 263.
transplants compared with those receiving dialysis treatment in 66. Disney AP. Demography and survival of patients receiving treat-
Australia and New Zealand, 1991–2001. Nephrol Dial Transplant ment for chronic renal failure in Australia and New Zealand: Re-
2002; 17: 2212–2219. port on dialysis and renal transplantation treatment from the Aus-
49. Oniscu GC, Brown H, Forsythe JLR. Impact of cadaveric renal tralia and New Zealand Dialysis and Transplant Registry. Am J
transplantation on survival in patients listed for transplantation. J Kidney Dis 1995; 25: 165–175.
Am Soc Nephrol 2005; 16: 1859–1865. 67. Fauchald P, Albrechtsen D, Leivestad T, Pfeffer P, Talseth T, Flat-
50. Rabbat CG, Thorpe KE, Russell JD, Churchill DN. Comparison of mark A. Renal replacement therapy in patients over 60 years of
mortality risk for dialysis patients and cadaveric first renal trans- age. Transplant Proc 1988; 20: 432–433.
plant recipients in Ontario, Canada. J Am Soc Nephrol 2000; 11: 68. Ho YW, Chau KF, Leung CB, et al. Hong Kong registry report
917–922. 2004. Hong Kong J Nephrol 2005; 7: 38–46.
51. Burton PR, Walls J. Selection-adjusted comparison of life- 69. Krakauer H, Grauman JS, McMullan MR, Creede CC. The recent
expectancy of patients on continuous ambulatory peritoneal dial- U.S. experience in the treatment of end-stage renal disease by
ysis, haemodialysis, and renal transplantation. [erratum appears dialysis and transplantation. N Engl J Med 1983; 308: 1558–
in Lancet 1987; 1: 1330]. Lancet 1987; 1: 1115–1119. 1563.
52. Chavers BM, Solid CA, Gilbertson DT, Collins AJ. Infection- 70. Kramer A, Stel V, Zoccali C, et al. An update on renal replacement
related hospitalization rates in pediatric versus adult patients with therapy in Europe: ERA-EDTA Registry data from 1997 to 2006.
end-stage renal disease in the United States. J Am Soc Nephrol Nephrol Dial Transplant 2009; 24: 3557–3566.
2007; 18: 952–959. 71. Kreis H. Selection of hemodialysis versus cadaveric transplanta-
53. Mazzuchi N, Gonzalez-Martinez F, Carbonell E, Curi L, Fernandez- tion. Kidney Int Suppl 1978: S91–S94.
Cean J, Orihuela S. Comparison of survival for haemodialysis 72. Krumlovsky FA, del Greco F, Simon NM, Roguska J. Morbidity
patients vs renal transplant recipients treated in Uruguay. Nephrol and mortality of chronic hemodialysis compared to renal trans-
Dial Transplant 1999; 14: 2849–2854. plantation. Trans Am Soc Artif Intern Organs 1975; 21: 102–
54. Schaubel D, Desmeules M, Mao Y, Jeffery J, Fenton S. Survival 107.
experience among elderly end-stage renal disease patients. A 73. Lim TO, Lim YN, Tan CC, Lee DG, Morad Z. Malaysian dialysis
controlled comparison of transplantation and dialysis. Transplan- and transplant registry report. Nephrology 1998; 4: 123–126.
tation 1995; 60: 1389–1394. 74. Price JD, Ashby KM, Reeve CE. Results of 12 years’ treatment
55. Zimmermann PR, Camey SA, Mari JdJ. A cohort study to assess of chronic renal failure by dialysis and transplantation. Can Med
the impact of depression on patients with kidney disease. Int J Assoc J 1978; 118: 263–266.
Psychiatry Med 2006; 36: 457–468. 75. Silins J, Fortier L, Mao Y, et al. Mortality rates among patients
56. Bonal J, Cleries M, Vela E. Transplantation versus haemodialy- with end-stage renal disease in Canada, 1981–1986. CMAJ 1989;
sis in elderly patients. Renal Registry Committee. Nephrol Dial 141: 677–682.
Transplant 1997; 12: 261–264. 76. Cantaluppi A, Ponticelli C, Frontini A, Licini R, Tarantino A, Mecca
57. Alamartine E, Leroy G, Toulon J, et al. Influence of dialysis and G. Dialysis versus integrated programme of dialysis and trans-
kidney transplantation on the survival of patients with end-stage plantation. Proc Eur Dial Transplant Assoc 1977; 14: 593–595.
chronic kidney failure. A multifactorial analysis. Presse Med 1991; 77. Gill JS, Rose C, Pereira BJ, Tonelli M. The importance of tran-
20: 21–24. sitions between dialysis and transplantation in the care of end-
58. Garcia-Garcia G, Deddens JA, D’Achiardi-Rey R, et al. Results of stage renal disease patients. Kidney Int 2007; 71: 442–447.
treatment in patients with end-stage renal disease: A multivariate 78. Segoloni GP, Messina M, Tognarelli G, et al. Survival probabilities
analysis of risk factors and survival in 341 successive patients. for renal transplant recipients and dialytic patients: A single center
Am J Kidney Dis 1985; 5: 10–18. prospective study. Transplant Proc 1998; 30: 1739–1741.
59. Pauly RP, Gill JS, Rose CL, et al. Survival among nocturnal home 79. Straathof-Galema L, van Saase JL, Verburgh CA, de Fijter JW,
haemodialysis patients compared to kidney transplant recipients. Schut NH, van Dorp WT. Morbidity and mortality during renal re-
Nephrol Dial Transplant 2009; 24: 2915–2919. placement therapy: Dialysis versus transplantation. Clin Nephrol
60. Vollmer WM, Wahl PW, Blagg CR. Survival with dialysis and trans- 2001; 55: 227–232.
plantation in patients with end-stage renal disease. N Engl J Med 80. Baiardi F, Degli Esposti E, Cocchi R, et al. Effects of clinical and in-
1983; 308: 1553–1558. dividual variables on quality of life in chronic renal failure patients.
61. Locatelli F, Marcelli D, Conte F, et al. 1983 to 1992: Report on J Nephrol 2002; 15: 61–67.
regular dialysis and transplantation in Lombardy. Am J Kidney Dis 81. Cheawchanwattana A, Limwattananon C, Gross C, et al. The va-
1995; 25: 196–205. lidity of a new practical quality of life measure in patients on
American Journal of Transplantation 2011; 11: 2093–2109 2107
C.Agnello SE 0222
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 226 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
420
Tonelli et al.
renal replacement therapy. J Med Assoc Thai 2006; 89(suppl 2): 102. Moe SM, O’Neill KD, Reslerova M, Fineberg N, Persohn S, Meyer
S207–S17. CA. Natural history of vascular calcification in dialysis and trans-
82. Fujisawa M, Ichikawa Y, Yoshiya K, et al. Assessment of health- plant patients. [see comment][erratum appears in Nephrol Dial
related quality of life in renal transplant and hemodialysis patients Transplant. 2004; 19: 2933 Note: Resterova, Martina [corrected
using the SF-36 health survey. Urology 2000; 56: 201–206. to Reslerova, Martina]]. Nephrol Dial Transplant 2004; 19: 2387–
83. Lee AJ, Morgan CL, Conway P, Currie CJ. Characterisation and 2393.
comparison of health-related quality of life for patients with renal 103. Schon S, Ekberg H, Wikstrom B, Oden A, Ahlmen J. Renal re-
failure. Curr Med Res Opin 2005; 21: 1777–1783. placement therapy in Sweden. Scand J Urol Nephrol 2004; 38:
84. Overbeck I, Bartels M, Decker O, Harms J, Hauss J, Fangmann 332–339.
J. Changes in quality of life after renal transplantation. Transplant 104. Abbott KC, Hshieh P, Cruess D, et al. Hospitalized valvular heart
Proc 2005; 37: 1618–1621. disease in patients on renal transplant waiting list: Incidence,
85. Ozminkowski RJ, White AJ, Andrea Hassol MSPH, Michael Mur- clinical correlates and outcomes. Clin Nephrol 2003; 59: 79–
phy BS. General health of end stage renal disease program ben- 87.
eficiaries. Health Care Financ Rev 1997; 19: 121–144. 105. Tomasz W, Piotr S. A trial of objective comparison of quality of life
86. Rebollo P, Ortega F, Baltar JM, et al. Health related quality of life between chronic renal failure patients treated with hemodialysis
(HRQoL) of kidney transplanted patients: Variables that influence and renal transplantation. Ann Transplant 2003; 8: 47–53.
it. Clin Transplant 2000; 14: 199–207. 106. McDonald SP, Russ GR, Kerr PG, et al. ESRD in Australia and
87. Wight JP, Edwards L, Brazier J, Walters S, Payne JN, Brown CB. New Zealand at the end of the millennium: A report from the
The SF36 as an outcome measure of services for end stage renal ANZDATA registry. Am J Kidney Dis 2002; 40: 1122–1131.
failure. [see comment]. Qual Health Care 1998; 7: 209–221. 107. Piccoli GB, Mezza E, Anania P, et al. Patients on renal replace-
88. Griva K, Jayasena D, Davenport A, Harrison M, Newman SP. ment therapy for 20 or more years: A clinical profile. Nephrol Dial
Illness and treatment cognitions and health related quality of life Transplant 2002; 17: 1440–1449.
in end stage renal disease. Br J Health Psychol 2009; 14(Pt 1): 108. Lui SF. 1996 Hong Kong renal registry report: Central Renal Com-
17–34. mitee. Nephrology 1997; 3: 577–581.
89. Hariharan S, Johnson CP, Bresnahan BA, Taranto SE, McIntosh 109. Agodoa LY, Eggers PW. Renal replacement therapy in the United
MJ, Stablein D. Improved graft survival after renal transplantation States: Data from the United States Renal Data System. Am J
in the United States, 1988 to 1996. N Engl J Med 2000; 342: Kidney Dis 1995; 25: 119–133.
605–612. 110. Teraoka S, Toma H, Nihei H, et al. Current status of renal replace-
90. Gill JS. Cardiovascular disease in transplant recipients: Current ment therapy in Japan. Am J Kidney Dis 1995; 25: 151–164.
and future treatment strategies. Clin J Am Soc Nephrol 2008; 111. El-Reshaid K, Johny KV, Sugathan TN, Hakim A, Georgous M,
3(Suppl 2): S29–S37. Nampoory MR. End-stage renal disease and renal replacement
91. Halloran PF. Immunosuppressive drugs for kidney transplanta- therapy in Kuwait—Epidemiological profile over the past 4 1/2
tion. N Engl J Med 2004; 351: 2715–2729. years. Nephrol Dial Transplant 1994; 9: 532–538.
92. Yildirim A. The importance of patient satisfaction and health- 112. Del Pilar Garofano Plazas M, Morales MM, Extremera BG, Al-
related quality of life after renal transplantation. Transplant Proc hama JS. Quality of life in patients with end-stage renal disease.
2006; 38: 2831–2834. Study of 156 cases. Eur J Intern Med 1993; 4: 301–310.
93. Segey DL. Renal allograft survival: Getting better all the time. Am 113. Brunori G, Camerini C, Cancarini G, et al. Hospitalization: CAPD
J Transplant 2011; 11: 422–423. versus hemodialysis and transplant. Adv Perit Dial 1992; 8: 71–
94. Segey DL. Evaluating options for utility-based kidney allocation. 74.
Am J Transplant 2009; 9: 1513–1518. 114. Julius M, Hawthorne VM, Carpentier-Alting P, Kneisley J, Wolfe
95. Reade MC, Delaney A, Bailey MJ, Angus DC. Bench-to-bedside RA, Port FK. Independence in activities of daily living for end-
review: Avoiding pitfalls in critical care meta-analysis—Funnel stage renal disease patients: Biomedical and demographic corre-
plots, risk estimates, types of heterogeneity, baseline risk and lates. Am J Kidney Dis 1989; 13: 61–69.
the ecologic fallacy. Crit Care 2008; 12: 220. 115. Kjellstrand CM, Fryd D, Najarian JS. Late deaths on dialysis and
96. Ansell D, Roderick P, Hodsman A, Ford D, Steenkamp R, Tom- transplantation therapy. Contrib Nephrol 1989; 70: 64–74.
son C. UK renal registry 11th annual report (December 2008): 116. Petrie K. Psychological well-being and psychiatric disturbance in
Chapter 7 survival and causes of death of UK adult patients on dialysis and renal transplant patients. Br J Med Psychol 1989;
renal replacement therapy in 2007: National and centre-specific 62(Pt 1): 91–96.
analyses. Nephron Clin Pract 2009; 111(Suppl 1): c113–c139. 117. Morris PL, Jones B. Transplantation versus dialysis: A study of
97. Stel VS, Kramer A, Zoccali C, Jager KJ. The 2006 ERA-EDTA quality of life. Transplant Proc 1988; 20: 23–26.
registry annual report: A precis. J Nephrol 2009; 22: 1–12. 118. Churchill DN, Torrance GW, Taylor DW, et al. Measurement of
98. Patel RK, Mark PB, Johnston N, et al. Prognostic value of car- quality of life in end-stage renal disease: The time trade-off ap-
diovascular screening in potential renal transplant recipients: A proach. Clin Invest Med 1987; 10: 14–20.
single-center prospective observational study. Am J Transplant 119. Evans RW, Manninen DL, Garrison LP Jr., et al. The quality of
2008; 8: 1673–1683. life of patients with end-stage renal disease. N Engl J Med 1985;
99. Buturovic-Ponikvar J. Expert group for dialysis in S. Renal re- 312: 553–559.
placement therapy in Slovenia: 2003 annual report. Ther Apher 120. Minetti L, Civati G, Brando B. A comparison between main-
Dial 2005; 9: 196–201. tenance hemodialysis and transplantation in the treatment of
100. Niu S-F, Li IC. Quality of life of patients having renal replacement end-stage renal disease. Transplant Proc 1985; 17(suppl 2): 28–
therapy. J Adv Nurs 2005; 51: 15–21. 31.
101. Schaubel DE, Cai J. Analysis of clustered recurrent event data 121. Hellerstedt WL, Johnson WJ, Ascher N, et al. Survival rates
with application to hospitalization rates among renal failure pa- of 2,728 patients with end-stage renal disease. Mayo Clin Proc
tients. Biostatistics 2005; 6: 404–419. 1984; 59: 776–783.
2108 American Journal of Transplantation 2011; 11: 2093–2109
C.Agnello SE 0223
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 227 of 569 PageID #:
16006143, 2011, 10, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1600-6143.2011.03686.x by Test, Wiley Online Library on [04/02/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
421
Systematic Review of Kidney Transplantation
122. Cestero RV, Jacobs MO, Freeman RB. A regional end-stage re- 131. Samsa G, Edelman D, Rothman ML, Williams GR, Lipscomb J,
nal disease program: Twelve years’ experience. Ann Intern Med Matchar D. Determining clinically important differences in health
1980; 93: 494–498. status measures: A general approach with illustration to the
123. Nicholls AJ, Catto GR, Edward N, Engeset J, Macleod M. Accel- Health Utilities Index Mark II. Pharmacoeconomics 1999; 15:
erated atherosclerosis in long-term dialysis and renal-transplant 141–155.
patients: Fact or fiction? Lancet 1980; 1: 276–278.
124. Avram MM, Slater PA, Fein PA, Altman E. Comparative survival
of 673 patients with chronic uremia treated with renal transplan- Supporting Information
tation (RT) and maintenance hemodialysis (MD). Trans Am Soc
Artif Intern Organs 1979; 25: 391–393. Additional supporting information may be found in the on-
125. Dumler F, Levin NW, Santiago G, Cruz C, Cortes P, Dienst S.
line version of this article.
End-stage renal disease in diabetics: Dialysis or transplantation?
Lancet 1979; 2: 412–413.
126. Hull A, Peters P, Dickerman R, et al. Comparisons of dialysis Table S1: Literature search strategies
and transplant results from one center. Transplant Proc 1979; 11:
125–126.
Table S2: Quality assessment of included studies
127. Bonney S, Finkelstein FO, Lytton B, Schiff M, Steele TE. Treat-
ment of end-stage renal failure in a defined geographic area. Arch
Intern Med 1978; 138: 1510–1513.
Table S3: Length of hospital stay among transplant recipi-
128. Golper TA, Barry JM, Bennett WM, Porter GA. Primary cadaver ents, compared with dialysis patients
kidney transplantation in older patients: Survival equal to dialysis.
Trans Am Soc Artif Intern Organs 1978; 24: 282–287. Figure S1: Unadjusted risk ratio of all-cause mortality
129. Higgins MR, Grace M, Dossetor JB. Survival of patients treated
for end-stage renal disease by dialysis and transplantation. Can Please note: Wiley-Blackwell is not responsible for the con-
Med Assoc J 1977; 117: 880–883. tent or functionality of any supporting materials supplied
130. Lowrie EG, Lazarus JM, Mocelin AJ, et al. Survival of patients un- by the authors. Any queries (other than missing material)
dergoing chronic hemodialysis and renal transplantation. N Engl should be directed to the corresponding author for the ar-
J Med 1973; 288: 863–867. ticle.
American Journal of Transplantation 2011; 11: 2093–2109 2109
C.Agnello SE 0224
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 228 of 569 PageID #:
422
EXHIBIT L
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0225
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 229 of 569 PageID #:
423
Supplement
KDIGO Clinical Practice Guideline on the
Evaluation and Care of Living Kidney Donors
Krista L. Lentine, MD, PhD,1 Bertram L. Kasiske, MD,2 Andrew S. Levey, MD,3 Patricia L. Adams, MD,4
Josefina Alberú, MD,5 Mohamed A. Bakr, MD,6 Lorenzo Gallon, MD,7 Catherine A. Garvey, RN,8
Sandeep Guleria, MBBS, MS, DNB,9 Philip Kam-Tao Li, MD,10 Dorry L. Segev, MD, PhD,11 Sandra J. Taler, MD,12
Kazunari Tanabe, MD, PhD,13 Linda Wright, MHSc, MSW,14 Martin G. Zeier, MD,15 Michael Cheung, MA,16
and Amit X. Garg, MD, PhD17
Abstract: The 2017 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline on the Evaluation and Care
of Living Kidney Donors is intended to assist medical professionals who evaluate living kidney donor candidates and provide care
before, during and after donation. The guideline development process followed the Grades of Recommendation Assessment, De-
velopment, and Evaluation (GRADE) approach and guideline recommendations are based on systematic reviews of relevant stud-
ies that included critical appraisal of the quality of the evidence and the strength of recommendations. However, many
recommendations, for which there was no evidence or no systematic search for evidence was undertaken by the Evidence Review
Team, were issued as ungraded expert opinion recommendations. The guideline work group concluded that a comprehensive ap-
proach to risk assessment should replace decisions based on assessments of single risk factors in isolation. Original data analyses
were undertaken to produce a “proof-in-concept” risk-prediction model for kidney failure to support a framework for quantitative risk
assessment in the donor candidate evaluation and defensible shared decision making. This framework is grounded in the si-
multaneous consideration of each candidate's profile of demographic and health characteristics. The processes and frame-
work for the donor candidate evaluation are presented, along with recommendations for optimal care before, during, and
after donation. Limitations of the evidence are discussed, especially regarding the lack of definitive prospective studies
and clinical outcome trials. Suggestions for future research, including the need for continued refinement of long-term risk pre-
diction and novel approaches to estimating donation-attributable risks, are also provided.
(Transplantation 2017;101(8S): S1–S109)
In citing this document, the following format should be used: Kidney Disease: Improving Global Outcomes (KDIGO) Living Kidney
Donor Work Group. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation 2017;
101(Suppl 8S):S1–S109.
Received 10 February 2017.
17
Accepted 20 March 2017. Western University London, Canada.
1
Saint Louis University School of Medicine, St. Louis, MO. Guideline Cochairs, K.L.L, A.X.G., contributed equally.
2
Hennepin County Medical Center, Minneapolis, MN. This Clinical Practice Guideline is based upon systematic literature searches last
3
conducted in September 2014 supplemented with additional evidence through
Tufts Medical Center, Boston, MA. January 2017. It is designed to assist decision making. It is not intended to define
4
Wake Forest School of Medicine, Winston-Salem, NC. a standard of care, and should not be interpreted as prescribing an exclusive
5
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico. course of management. Variations in practice will inevitably and appropriately
6
occur when considering the needs of individual patients, available resources, and
Mansoura University Mansoura, Egypt. limitations unique to an institution or type of practice. Healthcare professionals
7
Northwestern University, Chicago, IL. using these recommendations should decide how to apply them to their own
8
University of Minnesota, Minneapolis, MN. clinical practece.
9
Indraprastha Apollo Hospitals, New Delhi, India. Kidney Disease: Improving Global Outcomes (KDIGO) makes every effort to avoid
10
any actual or reasonably perceived conflicts of interest that may arise from an
Chinese University of Hong Kong, Hong Kong, China. outside relationship or a personal, professional, or business interest of a member
11
Johns Hopkins University, School of Medicine, Baltimore, MD. of the work group. All members of the work group are required to complete, sign,
12
Mayo Clinic, Rochester, MN. and submit a disclosure and attestation form showing all such relationships that
13
might be perceived as or are actual conflicts of interest. This document is updated
Tokyo Women's Medical University, Tokyo, Japan. annually and information is adjusted accordingly. All reported information is published in
14
University of Toronto, Toronto, Canada. its entirety at the end of the document and is kept on file at KDIGO.
15
University Hospital Heidelberg, Heidelberg, Germany. Disclosure and funding information can be found in the Appendix on page S106.
16
KDIGO, Brussels, Belgium. Correspondence: Krista L. Lentine, MD, PhD (lentinek@slu.edu).
C.Agnello SE 0226
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 230 of 569 PageID #:
S8 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 424 www.transplantjournal.com
Supplemental digital content (SDC) is available for this article. Direct URL citations (CCBY-NC-ND), where it is permissible to download and share the work provided it
appear in the printed text, and links to the digital files are provided in the HTML is properly cited. The work cannot be changed in any way or used commercially
text of this article on the journal’s Web site (www.transplantjournal.com). without permission from the journal.
Copyright © 2017 KDIGO. This is an open-access article distributed under the terms ISSN: 0041-1337/17/10108-00S1
of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 DOI: 10.1097/TP.0000000000001769
SUMMARY OF RECOMMENDATION STATEMENTS above the transplant program’s acceptable risk thresh-
All recommendation statements are not graded unless speci- old, the risk is not acceptable for donation. If a donor
candidate’s postdonation risk is below the transplant
fied otherwise.
program’s acceptance threshold, the candidate makes
the decision whether or not to proceed with donation.
CHAPTER 1: GOALS OF EVALUATION, FRAMEWORK 1.14: If a donor candidate is not acceptable, the transplant
FOR DECISION-MAKING, AND ROLES AND program should explain the reason for nonacceptance
RESPONSIBILITIES to the donor candidate.
1.15: Transplant programs should protect donor candidate’s
Goals and Principles of Evaluation privacy regarding the evaluation, including all consider-
ations in the decision to donate or not.
1.1: The donor candidate’s willingness to donate a kidney vol-
untarily without undue pressure should be verified. Roles and Responsibilities
1.2: The benefits and risks of kidney donation should be
assessed for each donor candidate. 1.16: A multidisciplinary transplant program team knowl-
1.3: The decision to accept or exclude a donor candidate edgeable in kidney donation and transplantation should
should follow transplant program policies. evaluate, care for, and formulate a plan for donor care
1.4: Donor candidate decision-making should be facilitated including long-term follow-up.
through education and counseling on individualized 1.17: Transplant programs should minimize conflict of interest
risks and benefits, methods to minimize risks, and the by providing at least one key team member not involved
need for postdonation follow-up. in the care or evaluation of the intended recipient who
1.5: For an accepted donor candidate, a plan for donation evaluates the donor candidate and participates in the de-
care and follow-up should be formulated to minimize termination of donor acceptance.
risks of donation. 1.18: Transplant programs should conduct as efficient a do-
1.6: For an excluded donor candidate, a plan for any needed nor evaluation as possible, meeting the needs of donor
care and support should be formulated. candidates, intended recipients and transplant programs.
Framework for Decision-Making
CHAPTER 2: INFORMED CONSENT
1.7: The donor candidate, the intended recipient, and the
transplant program must all agree with the decision to Process of Informed Consent
proceed with donation in concordance with transplant
program policies and informed consent. 2.1: Informed consent for donation should be obtained from
1.8: Transplant program policies must be defensible based on the donor candidate in the absence of the intended recip-
current understanding of the risks and benefits of kidney ient, family members and other persons who could influ-
donation, and should apply to all donor candidates eval- ence the donation decision.
uated at the center.
1.9: Each transplant program should establish policies de- Capacity for Decision Making
scribing psychosocial criteria that are acceptable for dona- 2.2: The donor candidate’s capacity to provide informed con-
tion, including any program constraints on acceptable sent (ie, ability to understand the risks, benefits and
relationships between the donor candidate and the consequences of donation) should be confirmed before
intended recipient. proceeding with evaluation and donation.
1.10: All donor candidates should be evaluated using the same 2.3: Substitute decision makers should not be used on behalf
criteria, regardless of whether donation is directed to- of a donor candidate who lacks the capacity to provide
wards a designated recipient. informed consent (eg, children or those who are mentally
1.11: Each transplant program should establish policies de- challenged), except under extraordinary circumstances
scribing medical criteria that are acceptable for dona- and only after ethical and legal review.
tion, addressing when possible, numeric thresholds for
short-term and long-term postdonation risks above Content of Disclosure
which the transplant program will not proceed with do-
nation. Risks should be expressed as absolute rather 2.4: Protocols should be followed to provide each donor can-
than relative risks. didate with information on:
1.12: When possible, transplant programs should provide each
donor candidate with individualized quantitative esti- • The processes of evaluation, donor acceptance, and follow-up
mates of short-term and long-term risks from donation, • The types of information that may be discovered dur-
including recognition of associated uncertainty, in a man- ing the evaluation, and what the transplant program
ner that is easily understood by donor candidates. will do with such information
1.13: Transplant programs should evaluate donor candidate • Individualized risks, benefits and expected outcomes of the
risks in comparison to predetermined thresholds for ac- donor evaluation, donation, and postdonation health, in-
ceptance. If a donor candidate’s postdonation risk is cluding a discussion of the uncertainty in some outcomes
C.Agnello SE 0227
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 231 of 569 PageID #:
KDIGO Living Kidney Donor Work Group S9
425
• Treatment alternatives available to transplant candi- 4.2: Donor candidates who smoke should be advised to quit at
dates, and average expected outcomes least 4 weeks before donation to reduce their risk of peri-
• How personal health information will be handled operative complications, and commit to lifelong absti-
• Availability of transplant program personnel for support nence to prevent long-term complications.
Comprehension of Disclosed Information CHAPTER 5: PREDONATION KIDNEY FUNCTION
2.5: The donor candidate’s understanding of the relevant in- Evaluation
formation on the risks and benefits of donation should
be confirmed before proceeding with donation. 5.1: Donor kidney function should be expressed as glomerular fil-
tration rate (GFR) and not as serum creatinine concentration.
Voluntarism 5.2: Donor GFR should be expressed in mL/min per 1.73 m2
rather than mL/min.
2.6: Donor candidates should have adequate time to consider 5.3: Donor glomerular filtration rate (GFR) should be esti-
information relevant to deciding whether they wish to do- mated from serum creatinine (eGFRcr) for initial assessment,
nate or not. following recommendations from the KDIGO 2012 CKD
2.7: A donor candidate’s decision to withdraw at any stage of guideline.
the evaluation process should be respected and supported 5.4: Donor GFR should be confirmed using one or more of the
in a manner that protects confidentiality. following measurements, depending on availability:
2.8: A donor candidate who decides not to donate and has dif-
ficulty communicating that decision to the intended re- • Measured GFR (mGFR) using an exogenous filtration
cipient should be assisted with this communication by marker, preferably urinary or plasma clearance of inu-
the transplant program. lin, urinary or plasma clearance of iothalamate, uri-
nary or plasma clearance of 51Cr-EDTA, urinary or
plasma clearance of iohexol, or urinary clearance of
99m
Tc-DTPA
CHAPTER 3: COMPATIBILITY TESTING,
INCOMPATIBLE TRANSPLANTATION, AND PAIRED • Measured creatinine clearance (mCrCl)
DONATION • Estimated GFR from the combination of serum creati-
nine and cystatin C (eGFRcr-cys) following recommen-
Evaluation dations from the KDIGO 2012 CKD guideline
• Repeat estimated GFR from serum creatinine (eGFRcr)
3.1: Donor ABO blood typing should be performed twice be-
fore donation to reduce the risk of unintended blood type
incompatible transplantation. 5.5: If there are parenchymal, vascular or urological abnor-
3.2: Donor blood group A subtype testing should be per- malities or asymmetry of kidney size on renal imaging,
formed when donation is planned to recipients with single kidney GFR should be assessed using radionuclides
anti-A antibodies. or contrast agents that are excreted by glomerular filtra-
3.3: Human leukocyte antigen (HLA) typing for major histo- tion (eg, 99mTc-DTPA).
compatibility complex (MHC) Class I (A, B, C) and Class
II (DP, DQ, DR) should be performed in donor candidates Selection
and their intended recipients, and donor-specific anti-
HLA antibodies should be assessed in intended recipients. 5.6: GFR of 90 mL/min per 1.73 m2 or greater should be consid-
ered an acceptable level of kidney function for donation.
Counseling 5.7: The decision to approve donor candidates with GFR 60
to 89 mL/min per 1.73 m2 should be individualized based
3.4: Donor candidates who are ABO blood group or HLA in- on demographic and health profile in relation to the
compatible with their intended recipient should be informed transplant program’s acceptable risk threshold.
of availability, risks, and benefits of treatment options, in- 5.8: Donor candidates with GFR less than 60 mL/min per
cluding kidney paired donation and incompatibility man- 1.73 m2 should not donate.
agement strategies. 5.9: When asymmetry in GFR, parenchymal abnormalities,
3.5: If a donor candidate and their intended recipient are blood vascular abnormalities, or urological abnormalities are
type or crossmatch incompatible, transplantation should present but do not preclude donation, the more severely
be performed only with an effective incompatibility man- affected kidney should be used for donation.
agement strategy.
3.6: Nondirected donor candidates should be informed of Counseling
availability, risks and benefits of participating in kidney
paired donation. 5.10: We suggest that donor candidates be informed that the fu-
ture risk of developing kidney failure necessitating treat-
ment with dialysis or transplantation is slightly higher
because of donation; however, average absolute risk in
CHAPTER 4: PREOPERATIVE EVALUATION the 15 years following donation remains low. (2C)
AND MANAGEMENT
4.1: Donor candidates should receive guideline-based evalua-
CHAPTER 6: PREDONATION ALBUMINURIA
tion and management used for other noncardiac surgeries
to minimize risks of perioperative complications, includ- Evaluation
ing a detailed history and examination to assess risks for car-
diac, pulmonary, bleeding, anesthesia-related and other 6.1: Donor proteinuria should be measured as albuminuria,
perioperative complications. not total urine protein.
C.Agnello SE 0228
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 232 of 569 PageID #:
S10 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S426 www.transplantjournal.com
6.2: Initial evaluation of donor albuminuria (screening) should CHAPTER 9: HYPERURICEMIA, GOUT, AND
be performed using urine albumin-to-creatinine ratio MINERAL AND BONE DISEASE
(ACR) in a random (untimed) urine specimen.
6.3: Donor albuminuria should be confirmed using: Evaluation
• Albumin excretion rate (AER, mg/day [mg/d]) in a
timed urine specimen 9.1: Donor candidates should be asked about prior epi-
sodes of gout.
• Repeat ACR if AER cannot be obtained
Counseling
Selection
9.2: Donor candidates may be informed that donation is as-
6.4: Urine AER less than 30 mg/d should be considered an ac- sociated with an increase in serum uric acid concentra-
ceptable level for donation. tion, which may increase the risk for gout.
6.5: The decision to approve donor candidates with AER 30 9.3: Donor candidates and donors with prior episodes of
to 100 mg/d should be individualized based on demo- gout should be informed of recommended methods to
graphic and health profile in relation to the transplant reduce their risk of future episodes of gout.
program’s acceptable risk threshold.
6.6: Donor candidates with urine AER greater than 100 mg/d
should not donate.
CHAPTER 10: PREDONATION BLOOD PRESSURE
Evaluation
CHAPTER 7: PREDONATION HEMATURIA 10.1: Blood pressure should be measured before donation on at
Evaluation least 2 occasions by clinical staff trained in accurate measure-
ment technique, using equipment calibrated for accuracy.
7.1: Donor candidates should be assessed for microscopic 10.2: When the presence or absence of hypertension in a do-
hematuria. nor candidate is indeterminate based on history and
7.2: Donor candidates with persistent microscopic hematuria clinic measurements (eg, blood pressure is high normal
should undergo testing to identify possible causes, which or variable), blood pressure should be further evaluated
may include: using ambulatory blood pressure monitoring (ABPM) or
• Urinalysis and urine culture to assess for infection repeated using standardized blood pressure measurements.
• Cystoscopy and imaging to assess for urinary tract
malignancy Selection
• 24-hour urine stone panel to assess for nephrolithiasis 10.3: Normal blood pressure, as defined by guidelines for the
and/or microlithiasis general population in the country or region where dona-
• Kidney biopsy to assess for glomerular disease (eg, thin tion is planned, is acceptable for donation.
basement membrane nephropathy, IgA nephropathy, 10.4: Donor candidates with hypertension that can be con-
Alport syndrome) trolled to systolic blood pressure less than 140 mm Hg
and diastolic blood pressure less than 90 mm Hg using
Selection 1 or 2 antihypertensive agents, who do not have evi-
7.3: Donor candidates with hematuria from a reversible cause dence of target organ damage, may be acceptable for do-
that resolves (eg, a treated infection) may be acceptable nation. The decision to approve donor candidates with
for donation. hypertension should be individualized based on demo-
7.4: Donor candidates with IgA nephropathy should not donate. graphic and health profile in relation to the transplant
program’s acceptable risk threshold.
CHAPTER 8: KIDNEY STONES Counseling
Evaluation 10.5: Donor candidates should be counseled on lifestyle inter-
ventions to address modifiable risk factors for hyperten-
8.1: Donor candidates should be asked about prior kidney sion and cardiovascular disease, including healthy diet,
stones, and related medical records should be reviewed smoking abstinence, achievement of healthy body weight,
if available. and regular exercise according to guidelines for the gen-
8.2: The imaging performed to assess anatomy before donor eral population. These measures should be initiated be-
nephrectomy (eg, computed tomography angiogram) fore donation and maintained lifelong.
should be reviewed for the presence of kidney stones. 10.6: We suggest that donor candidates should be informed
8.3: Donor candidates with prior or current kidney stones that blood pressure may rise with aging, and that dona-
should be assessed for an underlying cause. tion may accelerate a rise in blood pressure and need for
Selection antihypertensive treatment over expectations with nor-
mal aging. (2D)
8.4: The acceptance of a donor candidate with prior or cur-
rent kidney stones should be based on an assessment of
stone recurrence risk and knowledge of the possible CHAPTER 11: PREDONATION METABOLIC AND
consequences of kidney stones after donation. LIFESTYLE RISK FACTORS
Counseling Identification of Metabolic and Lifestyle Risk Factors
8.5: Donor candidates and donors with current or prior kid- 11.1: Risk factors for kidney and cardiovascular disease
ney stones should follow general population, evidence- should be identified before donation and addressed
based guidelines for the prevention of recurrent stones. by counseling to promote long-term health.
C.Agnello SE 0229
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 233 of 569 PageID S11
KDIGO Living Kidney Donor Work Group
#:
427
Obesity 12.2: Donor candidates should be assessed for factors asso-
ciated with an increased likelihood of endemic or unex-
11.2: Body mass index (BMI) should be computed based on pected infections, including geographic, seasonal,
weight and height measured before donation, and classi- occupational, animal and environmental exposures.
fied based on World Health Organization (WHO) criteria 12.3: Donor candidates should complete a urinalysis and testing
for the general population or race-specific categories. for HIV, HBV, HCV, cytomegalovirus (CMV), Epstein-
11.3: The decision to approve donor candidates with obesity Barr virus (EBV), and Treponema pallidum (syphilis).
and BMI >30 kg/m2 should be individualized based on 12.4: If indicated by regional epidemiology or individual history,
demographic and health profile in relation to the trans- donor candidates should complete testing for Mycobacte-
plant program’s acceptable risk threshold. rium tuberculosis, Strongyloides, Trypanosoma cruzi,
11.4: Donor candidates who have had bariatric surgery West Nile virus, Histoplasmosis, and/or Coccidiomycosis.
should be assessed for risk of nephrolithiasis. 12.5: Transplant programs should develop protocols to screen
donor candidates for emerging infections in consultation
Glucose Intolerance with local public health specialists.
11.5: Donor candidates should be asked about prior diagno- 12.6: In general, donor infection risk factor and microbiological
sis of diabetes mellitus, gestational diabetes, and family assessments should be performed or updated as close in
history of diabetes. time to donation as possible. For HIV, HBV and HCV,
11.6: Glycemia should be assessed by fasting blood glucose screening should be current within 28 days of donation.
and/or glycated hemoglobin (HbA1c) before donation.
11.7: 2-hour glucose tolerance or HbA1c testing should be Selection
performed in donor candidates with elevated fasting
12.7: If a donor candidate is found to have a potentially trans-
blood glucose, history of gestational diabetes, or family
missible infection, then the donor candidate, intended
history of diabetes in a first-degree relative, and results
recipient and transplant program team should weigh
should be used to classify diabetes or prediabetes status
the risks and benefits of proceeding with donation.
using established criteria for the general population.
11.8: Donor candidates with type 1 diabetes mellitus should
not donate.
11.9: The decision to approve donor candidates with predia- CHAPTER 13: CANCER SCREENING
betes or type 2 diabetes should be individualized based
Evaluation
on demographic and health profile in relation to the
transplant program’s acceptable risk threshold. 13.1: Donor candidates should undergo cancer screening con-
11.10: Donor candidates with prediabetes or type 2 diabetes sistent with clinical practice guidelines for the country or
should be counseled that their condition may progress region where the donor candidate resides. Transplant
over time and may lead to end-organ complications. programs should ensure that screening is current accord-
ing to guideline criteria at the time of donation.
Dyslipidemias
11.11: Fasting lipid profile (including total cholesterol, LDL-C, Selection
HDL-C and triglycerides) should be measured as part of
13.2: In general, donor candidates with active malignancy
an overall cardiovascular risk assessment before donation.
should be excluded from donation. In some cases of ac-
11.12: The decision to approve donor candidates with dyslip-
tive malignancy with low transmission risk, a clear man-
idemia should be individualized based on demographic
agement plan and minimal risk to the donor, donation
and health profile in relation to the transplant pro-
may be considered.
gram’s acceptable risk threshold.
13.3: A kidney with a small simple (Bosniak I) cyst can be left
Tobacco Use in the donor, particularly if there are compelling reasons
for donating the contralateral kidney.
11.13: The use of tobacco products should be assessed before 13.4: Donation of a kidney with a Bosniak II renal cyst should
donation. proceed only after assessment for the presence of solid
11.14: Donor candidates who use tobacco products should be components, septations, and calcifications on the preop-
counseled on the risks of perioperative complications, erative computed tomography scan (or magnetic reso-
cancer, cardio-pulmonary disease and kidney failure, nance imaging) to avoid accidental transplantation of a
should be advised to abstain from use of tobacco prod- kidney with cystic renal cell carcinoma.
ucts, and should be referred to a tobacco cessation sup- 13.5: Donor candidates with high grade Bosniak renal cysts (III
port program if possible. or higher) or small (T1a) renal cell carcinoma curable by
11.15: The decision to approve donor candidates who are ac- nephrectomy may be acceptable for donation on a case-
tive tobacco users should be individualized based on by-case basis.
demographic and health profile in relation to the trans- 13.6: Donor candidates with a history of treated cancer that has
plant program’s acceptable risk threshold. a low risk of transmission or recurrence may be accept-
able for donation on a case-by-case basis.
CHAPTER 12: PREVENTING INFECTION
TRANSMISSION CHAPTER 14: EVALUATION OF GENETIC
KIDNEY DISEASE
Evaluation
Evaluation
12.1: Risk for human immunodeficiency virus (HIV), hepatitis
B virus (HBV), and hepatitis C virus (HCV) infections 14.1: Donor candidates should be asked about their family
should be assessed before donation. history of kidney disease, and when present, the type
C.Agnello SE 0230
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 234 of 569 PageID #:
S12 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 428 www.transplantjournal.com
of disease, time of onset, and extra-renal manifestations mother and child, and should include anesthesia and
associated with the disease. analgesia planning for nursing mothers.
14.2: When the intended recipient is genetically related to the
donor candidate, the cause of the intended recipient’s kid- Counseling
ney failure should be determined whenever possible. The
intended recipient should consent to share this medical in- 15.8: Women with childbearing potential should be informed
formation with the donor evaluation team, and with the of the need to avoid becoming pregnant from the time of
donor candidate if it could affect the decision to donate. approval for donation to the time of recovery after ne-
phrectomy; a quantitative human chorionic gonadotro-
Selection pin (β-hCG) pregnancy test should be performed and
confirmed as negative immediately before donation.
14.3: Donor candidates found to have a genetic kidney disease
15.9: We suggest that women with childbearing potential be
that can cause kidney failure should not donate.
counseled about the effects donation may have on future
Counseling pregnancies, including the possibility of a greater likeli-
hood of being diagnosed with gestational hypertension
14.4: Donor candidates must provide informed consent for ge- or preeclampsia. (2C)
netic testing if indicated as part of their evaluation. Donor 15.10: Women with a prior hypertensive disorder of pregnancy
candidates should be informed of the possible effects of re- should be informed about their long-term risks.
ceiving a diagnosis of a genetic kidney disease, such as any 15.11: Women with childbearing potential who proceed with
impact on their ability to obtain health or life insurance. donation should be counseled on how to reduce the risk
14.5: In cases where it remains uncertain whether the donor of complications in future pregnancies.
candidate has a genetic kidney disease and whether the
disease can cause kidney failure, donation should pro- CHAPTER 16: PSYCHOSOCIAL EVALUATION
ceed only after informing the donor candidate of the
risks of donation if the disease manifests later in life. Evaluation
Autosomal Dominant Polycystic Kidney 16.1: Donor candidates should receive in-person psychoso-
Disease (ADPKD) cial evaluation, education and planning from health
professionals experienced in the psychosocial concerns
14.6: Donor candidates with ADPKD should not donate. of donor candidates and donors.
14.7: Donor candidates with a family history of ADPKD in a 16.2: To ensure voluntariness, at least a portion of the psy-
first-degree relative may be acceptable for donation if chosocial evaluation of the donor candidate should
they meet age-specific imaging or genetic testing criteria be performed in the absence of the intended recipient,
that reliably exclude ADPKD. family members and other persons who could influ-
ence the donation decision.
Apolipoprotein L1 (APOL1) Risk Alleles 16.3: Whenever possible, the psychosocial evaluation of the
donor candidate should be performed by health pro-
14.8: Apolipoprotein L1 (APOL1) genotyping may be offered fessionals not involved in the care of the intended
to donor candidates with sub-Saharan African ances- recipient.
tors. Donor candidates should be informed that having 16.4: Transplant programs should follow protocols for assessing
2 APOL1 risk alleles increases the lifetime risk of kidney the donor candidate’s psychosocial suitability, avail-
failure but that the precise kidney failure risk for an able support, preparation and concerns for donation.
affected individual after donation cannot currently
be quantified.
Selection
CHAPTER 15: PREGNANCY 16.5: Transplant programs should follow protocols defining
psychosocial factors that either exclude donation, or
Evaluation prevent further evaluation until resolution.
15.1: Female donor candidates should be asked about future Disclosures and Support
childbearing plans.
15.2: Female donor candidates should be asked about prior 16.6: We suggest that donor candidates be informed that donors
hypertensive disorders of pregnancy (eg, gestational hy- usually have good quality of life after donation (2D).
pertension, preeclampsia, or eclampsia). 16.7: Transplant programs should assist donor candidates
15.3: Local guidelines should be followed to confirm the ab- and donors in receiving psychosocial or psychiatric
sence of pregnancy before performing radiologic tests, support as needed.
including abdominal computed tomography (with io-
dinated contrast) or nuclear medicine GFR testing.
CHAPTER 17: ACCEPTABLE SURGICAL
Selection APPROACHES FOR DONOR NEPHRECTOMY
15.4: Women should not donate while pregnant. 17.1: Renal imaging (eg, computed tomographic angiogra-
15.5: Women should not be excluded from donation solely phy) should be performed in all donor candidates to
because they desire to conceive children after donation. assess renal anatomy before nephrectomy.
15.6: Women with a prior hypertensive disorder of preg- 17.2: The surgeon should have adequate training and experience
nancy may be acceptable for donation if their long- for the surgical approach used for the donor nephrectomy.
term postdonation risks are acceptable. 17.3: We suggest that “mini-open” laparoscopy or hand-
15.7: A decision to proceed with donation in the year after assisted laparoscopy by trained surgeons should be of-
childbirth should consider the psychological needs of fered as optimal approaches to donor nephrectomy.
C.Agnello SE 0231
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 235 of 569 PageID S13
KDIGO Living Kidney Donor Work Group
#:
429
However, in some circumstances, such as for donors policy on contact with the recipient and other paired do-
with extensive previous surgery and/or adhesions, nation participants at all stages in the donation process.
and at centers where laparoscopy is not routinely per- 18.10: Transplant programs should disclose the extent of the
formed, open nephrectomy (flank or laparotomy) may be expected postdonation program-patient relationship
acceptable. (2D) before donation, including whether the donor can seek
17.4: Robotic, single-port, and natural orifice transluminal medical care at the transplant center after donation.
nephrectomy should generally not be used for donor 18.11: Regional policies should ensure access to kidney re-
nephrectomy. placement therapy (dialysis and/or transplantation)
17.5: Nontransfixing clips, (eg, Weck Hem-o-lok) should not for donors who develop kidney failure.
be used to ligate the renal artery in donor nephrectomy;
instead, renal artery transfixation by suture ligature or
anchor staple within the vessel wall should be used.
CHAPTER 19: POSTDONATION FOLLOW-UP CARE
17.6: In the absence of reasons to procure the right kidney
(vascular, urological or other abnormalities), the left 19.1: A personalized postdonation care plan should be pro-
kidney should be procured in laparoscopic donor ne- vided before donation to clearly describe follow-up
phrectomy because of the relative technical ease associ- care recommendations, who will provide the care,
ated with a longer venous pedicle. and how often.
17.7: We suggest laparoscopic procurement of the right rather 19.2: The following should be performed at least annually
than the left living donor kidney may be performed if the postdonation:
surgeon has adequate training and experience. (2D)
17.8: Procurement of a living donor kidney with 3 or more ar- • Blood pressure measurement
teries should only be undertaken by surgeons with ade- • BMI measurement
quate experience. • Serum creatinine measurement with GFR estimation
17.9: A donor candidate with atherosclerotic renal artery dis- • Albuminuria measurement
ease or fibromuscular dysplasia involving the orifices of • Review and promotion of a healthy lifestyle including reg-
both renal arteries should not donate. ular exercise, healthy diet and abstinence from tobacco
• Review and support of psychosocial health and well-being
19.3: Donors should be monitored for CKD, and those meeting
CHAPTER 18: ETHICAL, LEGAL AND POLICY criteria for CKD should be managed according to the
CONSIDERATIONS 2012 KDIGO CKD Guideline.
19.4: Donors should receive age-appropriate healthcare main-
Ethical and Legal Framework
tenance, and management of clinical conditions and
18.1: Local laws and regulations on living donation should be health risk factors according to clinical practice guide-
followed and explained as needed to donor candidates. lines for the regional population.
18.2: Where local laws or policies impede the ethical practice
of living donation, avenues to advocate for change
should be explored. METHODS FOR GUIDELINE DEVELOPMENT
18.3: Autonomy (self-determination) in the willingness or not
to be considered as a living donor should be respected AIM
during all phases of the evaluation and donation pro- The overall aim of this project was to develop an evidence-
cesses. Transplant programs should support autonomy based clinical practice guideline on the evaluation and care
through a fully informed consent process. of living kidney donors. The guideline consists of recom-
mendation statements and supporting rationale, including
Policies for Donor Candidate Identification
summaries of systematically generated evidence on relevant
18.4: Public awareness of opportunities for living donation predefined clinical topics. The general Kidney Disease: Im-
should be increased through education, donor advocacy, proving Global Outcomes (KDIGO) guideline development
evaluation efficiencies, and removal of disincentives. method is described at: http://www.kdigo.org/home/guide-
18.5: Transplant candidates should be assisted in identify- lines/development, and unique considerations for application
ing living donor candidates, as long as these efforts re- to the current guideline are discussed below.
spect donor autonomy and do not exert undue pressure
to donate.
18.6: Donor candidates should be informed of the dangers PROCESS
of transplant tourism. The development of the KDIGO Clinical Practice
18.7: Transplant programs should define and disclose their Guideline on the Evaluation and Care of Living Kidney
policies for the acceptance of donor candidates identi- Donors included:
fied through public solicitation.
• Appointing work group (WG) members and the Evidence Re-
Financial Support
view Team (ERT)
18.8: Donor candidates should be informed of the availability • Discussing guideline development processes and methods
of legitimate financial assistance for expenses from eval- • Developing guideline scope of work, including submission of
uation and donation. proposed topics for public comment, and refining topics based
on public feedback
Communication of Policies • Identifying populations, interventions, risk factors, and out-
comes of interest
18.9: Nondirected donors and donors participating in paired • Selecting topics for systematic evidence review and conducting
donation should be informed of the transplant program’s the literature review by:
C.Agnello SE 0232
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 236 of 569 PageID #:
S14 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 430 www.transplantjournal.com
◯ Developing and implementing literature search strategies Establishing the Process for Guideline Development
◯ Screening abstracts and retrieving full-text articles based on The ERT performed a systematic literature search and or-
predefined eligibility criteria
ganized abstract and article screening. The ERT also coordi-
◯ Creating data extraction forms
◯ Extracting data from individual studies
nated the methodological and analytical processes and
◯ Standardizing methodology for evidence quality assessment
defined and standardized the methodology for performing
◯ Tabulating data from individual studies into summary tables literature searches, data extraction, and summarizing the ev-
and performing critical appraisal of the literature idence. The WG wrote the recommendation statements and
◯ Grading quality of evidence for each outcome across studies, supporting rationale, in consultation with the ERT. For rec-
and assessing the overall quality of evidence across outcomes ommendations with available evidence in the systematic re-
with the aid of evidence profiles view, the ERT reviewed draft recommendation statements
• Where applicable, grading recommendation strength and their corresponding grades for consistency with the con-
based on the quality of evidence and other considerations clusions of the evidence systematic review.
for recommendations with available evidence in the sys-
tematic review Formulating Questions of Interest
• Using de novo evidence generation, WG consensus and prior The KDIGO WG developed a scoping document to de-
KDIGO Guidelines to develop recommendations on topics scribe topics to be covered by the guideline. To inform the
not assigned to formal systematic review, but deemed impor- WG’s initial work, the ERT searched for and identified
tant for the guideline
existing clinical practice guidelines related to living kidney
• Developing supporting rationale and finalizing guideline
recommendations donation. The ERT extracted recommendations from prior
• Distributing the guideline draft for public review from November guidelines on the identified topics of interest for the current
to December 2015 guideline and provided a summary table of this information.
• Editing the guideline based on public feedback, and creating This document was distributed to the WG in 2013. Certain
the point-by-point response topics within the scoping document were considered relevant
to the systematic review based on importance and feasibility,
The WG cochairs, KDIGO cochairs and ERT met to re- and the ERT developed key research questions to address these
view the guideline development process, evidence review topics (Table 1). The Population, Intervention, Comparator,
topics, and systematic review process. After this, 2 in- Outcome, study Design, and Duration of follow-up
person meetings were held May 2014 and September 2014 (PICODDs) criteria for the systematic review (Table 2) are de-
with the WG, ERT, KDIGO cochairs and KDIGO support scribed in detail in an accompanying publication.3 Outcomes
staff to review the available evidence, formulate recommen- were selected and ranked by assessing patient-centeredness.
dation statements and their rationale. Details of each chapter Risk assessment periods were defined as perinephrectomy/
were discussed by teleconference between the WG cochairs, postnephrectomy (within 90 days of donation), and longer-
WG members and support staff before each in-person meet- term (after 90 days postdonation until the end of available
ing, and by email. The WG cochairs, ERT, and support staff follow-up). Long-term outcomes were based on a mean
also held regular calls until completion of the evidence review follow-up of at least 5 years.
and systematic review report, and the WG cochairs, KDIGO
Chair and support staff met by regular teleconferences until Ranking of Outcomes
guideline completion. The WG ranked outcomes of interest based on their im-
portance for informing clinical decision making, as “critical”,
Commissioning of the WG and the ERT
TABLE 1.
The KDIGO cochairs appointed the WG cochairs, who
then assembled the WG to include individuals with exper- Key questions defining the evidence review
tise in nephrology, organ donation, transplantation, sur- Key Question 1: What is the incidence of perinephrectomy/postnephrectomy
gery, bioethics, psychology, epidemiology and public policy. outcomes among living kidney donors undergoing different types
The University of Minnesota Veterans Administration Center of nephrectomy procedures?
for Chronic Disease Outcomes Research in Minneapolis, Key Question 2: Does the incidence of perinephrectomy/postnephrectomy
Minnesota was contracted to conduct systematic evidence re- outcomes vary by demographic subgroup (age, race, sex)?
view and provided expertise in guideline development meth- Key Question 3: Does the incidence of perinephrectomy/postnephrectomy
odology. The ERT was led by guideline methodologists and outcomes vary by the presence of donor IMAs (ie, obesity,
clinicians with expertise in nephrology and evidence-based hypertension, glucose intolerance)?
clinical practice guideline development. Key Question 4: What is the incidence of long-term health outcomes for living
kidney donors compared with healthy nondonors?
Defining the Scope and Topics Key Question 5: Does the incidence of long-term living kidney donor outcomes
The WG cochairs and the ERT defined the scope and goals vary by demographic subgroup (age, race, sex)?
of the guideline (including a list of critical and important out- Key Question 6: Does the incidence of long-term living kidney donor outcomes
comes) and drafted a preliminary list of topics and key clini- vary by the presence of donor IMAs (ie, obesity, hypertension, glucose
cal questions. The project scope was submitted for public intolerance)?
comment in October 2013 and refined based on the feed- Key Question 7: What is the incidence of maternal and fetal outcomes
back. The WG and ERT further developed and refined each among female living kidney donors who become pregnant after donation
topic and specified screening criteria, literature search strate- compared with healthy nondonors?
gies, and data extraction forms. IMA, isolated medical abnormality.
C.Agnello SE 0233
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 237 of 569 PageID S15
KDIGO Living Kidney Donor Work Group
#:
431
TABLE 2.
Systematic review screening criteria
Living kidney donor outcomes
Perinephrectomy/postnephrectomy Long-term
Population Living kidney donors Living kidney donors
Living kidney donors—demographic subgroup (age, sex, race)
Living kidney donors with specific IMAs
Donors related to recipient or with known family history of kidney disease
Women with postdonation pregnancy
Intervention Nephrectomy performed post-1994 Living kidney donation
Nephrectomy in donors with IMAs
Comparator Nephrectomy with different types of surgery; Healthy nondonors a (ie, nondonor with medical characteristics
Nephrectomy in donors without IMAs suggesting they meet living donor criteria))
Living kidney donors—demographic subgroups (age, sex, race)
Healthy nondonors a—demographic subgroups (age, sex, race)
Living kidney donors—without specific IMAs
Healthy nondonors a—with specific IMAs
Donors with unrelated recipient and no family history of kidney disease
Donors with predonation pregnancy
Healthy nondonors with pregnancy
Outcomes Critical: all-cause mortality Critical: all-cause mortality, CVD event, kidney failure, fetal death
High Importance: CVD event High importance: psychosocial outcomes, major pregnancy complications
Moderate Importance: perinephrectomy/postnephrectomy Moderate importance: fragility fractures, gastrointestinal bleeding,
complications; time to return to usual activities kidney stones, minor pregnancy complications
Intermediate Outcomes: blood loss; length Intermediate outcomes: kidney function, proteinuria, hypertension
of hospital stay
Study design Systematic reviews, randomized controlled Systematic reviews, randomized controlled trials, and observational studies
trials, and observational studies Full-text screening identified studies with total sample sizes (donor and
comparator combined) more than 50; studies with
total sample sizes more than 100 were extracted
Duration of follow-up Systematic reviews with outcomes measured up Full-text screening identified studies with outcomes measured 1 y
to 90 d postnephrectomy were extracted or later postdonation; studies with a mean duration of 5 y or more
Full-text screening identified studies with outcomes postdonation were extracted
measured up to 1 y postdonation for extraction
a
“Healthy” nondonor comparison groups must have matched or controlled for demographic and health characteristics. CVD, cardiovascular disease; IMA, isolated medical abnormality.
“high” or “moderate.” The hierarchy of perinephrectomy/ full text screening. Two investigators independently screened
postnephrectomy and long-term outcomes is noted in Table 2. full text to determine if PICODD criteria were met. A third
“Intermediate outcomes” are defined as events on the path- investigator resolved discrepancies. The ERT documented
way to clinical outcomes of interest. the inclusion and exclusion status of citations undergoing
full-text screening. The ERT often revisited the screening pro-
Literature Searches and Article Selection cess as the WG identified new outcomes or subgroups not in-
The ERT searched Ovid Medline, Ovid EMBASE, and the cluded in the original PICODDs. Screening criteria were
Cochrane Library to identify previous systematic reviews, liberal. The ERT did not extract data from all eligible studies.
randomized controlled trials (RCTs), and observational stud- To capture the highest quality and most relevant and mean-
ies published and indexed in bibliographic databases through ingful data as efficiently as possible, the ERT extracted data
September 2014. The ERT search strategy included relevant only from previous systematic reviews for perinephrectomy/
medical subject headings and natural language terms for the postnephrectomy outcomes Key Questions (KQ1-3) and
concept of living kidney donation (Supplemental Appendix from systematic reviews and select observational studies for
A, SDC, http://links.lww.com/TP/B432). These terms were long-term outcomes (KQ 4-7). The ERT extracted long-
combined with filters to select RCTs, systematic reviews, term outcomes data from observational studies with sample
and observational studies. Bibliographic database searches sizes over 100 and mean follow-up time of at least 5 years.
were supplemented with citation searches of highly relevant Explicit recognition of perspectives of comparison is criti-
systematic reviews. cal for drawing inferences about donor health outcomes
Two independent investigators reviewed titles and abstracts (eg, estimation of predonation risk, absolute postdonation
of search results published after 2003 to identify systematic risk, and donation-attributable risk)4 (Figure 1), and types
reviews, trials and observational studies relevant to the key of comparison were a critical consideration throughout the
questions. The ERT relied on citation searching of relevant sys- development of this guideline, including the design and
tematic reviews to identify relevant studies published before conduct of the evidence review. Studies reporting long-term
2004. Citations deemed eligible by either investigator underwent outcomes were required to include a nondonor comparison
C.Agnello SE 0234
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 238 of 569 PageID #:
S16 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 432 www.transplantjournal.com
FIGURE 1. Perspectives of risk in living kidney donation. These perspectives provide a framework for assessment of donor outcomes, inter-
pretation of observations, patient communication, and future research design. LKD, living kidney donors. Adapted with permission from Lentine
KL, Segev DL. Understanding and communicating medical risks for living kidney donors: a matter of perspective. J Am Soc Nephrol.
2017;28:12-24.4
group with baseline health characteristics similar to kidney Reviews (AMSTAR) criteria.5 The ERT assessed risk of bias
donors. Studies comparing living kidney donors to the for observational studies using an instrument developed
general population were not eligible. based on the Research Triangle Institute Item Bank for
assessing risk of bias and confounding in observational stud-
Data Extraction and Summary Tables ies of interventions or exposures.6 In this instrument, overall
For perinephrectomy/postnephrectomy outcomes defined summary risk of bias is based upon the collective risk of bias
in the search criteria, the ERT extracted data from relevant inherent in each domain and confidence that results are be-
comparisons in recent systematic reviews rather than perform- lievable given study limitations. The ERT used overall sum-
ing a de novo extraction process. The ERT extracted relevant mary risk of bias assessments when grading evidence
narrative information from systematic reviews that did not quality as described below.
provide meta-analyses. For long-term outcomes defined in the
search criteria, the ERT extracted data from observational stud- Evidence Profiles
ies and extracted pooled results from previous meta-analyses. The structured GRADE approach was used to grade the
One investigator extracted relevant study, population de- quality of the overall evidence (Table 3). Evidence profiles
mographic, and outcomes data from studies eligible for full consisting of tables examining all relevant outcomes,
extraction. Data fields extracted included author, year of including a summary of the results and judgments about
publication, setting, donor and comparison populations, in- the certainty and quality of the evidence, were used to
clusion and exclusion criteria, donor and comparison charac- facilitate this process. The GRADE approach is prescriptive
teristics, follow-up duration, descriptions, and results of in how evidence quality is assessed. The study design
outcomes. Relevant data were extracted into tables for de- suggests the initial quality of evidence: high for RCTs and
scriptive analysis. In several cases, many comparisons were low for observational studies. Of note for the current guide-
made within the same published study. In these cases, the line, most studies of outcomes in living kidney donation are
ERT extracted relevant comparisons but did not extract inel- not ethically or practically amenable to randomized con-
igible comparisons. trolled designs, limiting the possible quality rating based on
the nature of possible study designs. Evidence quality is then
Assessment of Prior Systematic Review Quality and lowered by one level if the studies in the evidence base for a
Individual Study Risk of Bias comparison have serious risk of bias, and by 2 levels is the ev-
The ERT assessed the quality of eligible systematic reviews idence base has very serious risk of bias. Evidence quality is
using modified A Measurement Tool to Assess Systematic also lowered when results across studies are inconsistent or
C.Agnello SE 0235
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 239 of 569 PageID S17
KDIGO Living Kidney Donor Work Group
#:
433
TABLE 3.
Evidence quality assessment criteria
Study design Quality of evidence Lower if Higher if
Randomized trial High Risk of Bias Large effect
−1 Serious +1 Large
−2 Very serious +2 Very Large
Moderate Inconsistency +1 If all plausible confounding would reduce a demonstrated effect or
−1 Serious +1 If all plausible confounding would suggest a spurious
−2 Very serious effect when results show no effect
Observational study Low Indirectness
−1 Serious
−2 Very serious
Imprecision
−1 Serious
−2 Very serious
Very Low Publication bias
−1 Likely
very inconsistent, if the relationship between the interven- been published separately as part of this guideline systematic
tion and the outcome is indirect, or if the outcome does not review.3
directly influence patient well-being. Additionally, evidence
quality is downgraded when estimates are imprecise and Results of the Systematic Review
publication bias is likely. Evidence quality improves with a The ERT’s search identified 4530 citations, of which 414
large effect size. A large effect size includes a relative risk met criteria for full text review after title and abstract screen-
(RR) confidence interval (CI) lower limit of at least 2; a very ing. The ERT identified an additional 70 references via
large effect size includes a RR CI lower limit of 5. Evidence supplemental citation searching, yielding a total of 484 ref-
quality is also increased when an effect is demonstrated after erences for full text review (Figure 2). Studies excluded
all plausible confounding has been addressed. Complete evi- after full-text review and exclusion reasons are listed in
dence profiles for KQs 1-7 can be found in the Supplemental Supplemental Appendix B, SDC, http://links.lww.com/
Evidence Report: Outcomes of Living Kidney Donation: TP/B432, of the evidence review publication.
A Systematic Review for a Clinical Practice Guideline by The ERT extracted study characteristics, conducted system-
the Kidney Diseases Improving Global Outcomes (KDIGO), atic review quality assessments and risk-of-bias assessments,
SDC, http://links.lww.com/TP/B434. Evidence on long-term and extracted relevant outcomes into evidence tables for all
outcomes as reviewed and appraised by the ERT has also studies eligible for extraction (Supplemental Appendix C, SDC,
FIGURE 2. Literature flow diagram. SR, systematic review.
C.Agnello SE 0236
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 240 of 569 PageID #:
S18 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 434 www.transplantjournal.com
http://links.lww.com/TP/B432 for perioperative/postoperative Grading the Strength of the Recommendations
studies; Supplemental Appendix D, SDC, http://links.lww. The strength of a recommendation is graded as level 1 or
com/TP/B432 for long-term outcomes studies of the evi- level 2. Table 4 shows the KDIGO nomenclature for grading
dence review publication; Evidence Report, SDC, http:// the strength of a recommendation and the implications of
links.lww.com/TP/B434). Results were grouped by Key Question. each level for patients, clinicians, and policy makers. Recom-
mendations can be for or against doing something. Each rec-
De Novo Evidence Generation ommendation includes an explicit link between the quality of
In developing the current guideline, the WG concluded the available evidence and the strength of that recommenda-
that the framework for assessing the acceptability of candi- tion. However, the strength of a recommendation is deter-
dates for living kidney donation needed to be restructured mined not only by the quality of the evidence, but also by
to include a comprehensive determination of risk to the do- other, often complex judgments regarding the size of the net
nor, based on simultaneous consideration of a composite medical benefit (potential risks vs benefit), values, and prefer-
profile of risk factors. No previous guidelines have advocated ences, and costs (Table 5). Formal decision analyses including
for this approach to the evaluation of living donor candi- cost analysis were not conducted.
dates, and there is a paucity of data to demonstrate its feasi-
bility and applicability. The WG therefore collaborated with
Grading the Overall Quality of Evidence
the Chronic Kidney Disease-Prognosis Consortium (CKD-PC)
to conduct a meta-analysis to produce a comprehensive risk- The quality of the overall body of evidence was then deter-
prediction model for end-stage kidney disease (ESKD) applica- mined on the basis of the quality grades for all outcomes of
ble to donor candidates. The development and application of interest, taking into account explicit judgments about the rel-
this clinical prediction tool are described in chapter 1 (Frame- ative importance of each outcome. The resulting 4 final cate-
work) of this guideline and in a separate publication.7 gories for the quality of overall evidence were: “A,” “B,”
To inform choice of methods for kidney function estimation “C,” or “D” (Table 6).
in the donor candidate evaluation, a web-based calculator was
developed to compute posttest probabilities for measured glo- Ungraded Statements
merular filtration rate (mGFR) above or below threshold This category was designed to allow the WG to issue advice
probabilities for decision-making based on estimated glomer- on topics not explicitly addressed in the systematic review. The
ular filtration rate (eGFR). The development and application current guideline is notable in that many clinically important
of this clinical tool are described in chapter 5 (Kidney Func- topics in living donation are not ethically or practically amena-
tion) of this guideline and in a separate publication.8 ble to randomized controlled study designs and have not been
not addressed in controlled observational studies. Thus, many
Grading the Quality of Evidence and the Strength of recommendations were generated on topics deemed important
Guideline Recommendations for the care of living donors that were not addressed by eligi-
A structured approach, based on GRADE1,9,10 and facili- ble studies in the systematic evidence review. These recom-
tated by the use of evidence profiles, was used to grade the mendations were developed using other literature and WG
quality of the overall evidence and the strength of recommen- consensus, and are therefore ‘ungraded.’
dations. For each topic with recommendations informed by As a result, very few of the guideline recommendations
the systematic review, the discussion of grading evidence were rated for strength of the recommendation and quality
quality was led by the ERT, and the discussion regarding the of the evidence. This is not to say that there was no evi-
strength of the recommendations was led by the WG cochairs. dence for such “ungraded” guideline recommendations,
The “strength of a recommendation” indicates the extent to but the WG and ERT only graded recommendations that
which one can be confident that adherence to the recommen- were included as part of the ERT’s systematic review and
dation will do more good than harm. The “quality of a body fulfilled the a priori search inclusion criteria. The WG felt that
of evidence” refers to the extent to which confidence in an es- such “good practice statements” were necessary to address im-
timate of effect is sufficient to support a recommendation. portant aspects of donor care, and their preponderance may
TABLE 4.
KDIGO nomenclature and description for grading recommendations
Implications
a
Grade Patients Clinicians Policy
Level 1 ‘We recommend’ Most people in your situation would want Most patients should receive the The recommendation can be evaluated as
the recommended course of action and recommended course of action a candidate for developing a policy or a
only a small proportion would not performance measure
Level 2 ‘We suggest’ The majority of people in your situation Different choices will be appropriate for The recommendation is likely to require
would want the recommended course different patients. Each patient needs help substantial debate and involvement of
of action, but many would not to arrive at a management decision consistent stakeholders before policy can
with her or his values and preferences be determined
a
The additional category ‘Not Graded’ is used, typically, to provide guidance based on common sense or where the topic does not allow adequate application of evidence. The most common examples include
recommendations regarding monitoring intervals, counseling, and referral to other clinical specialists. Ungraded recommendations are generally written as simple declarative statements, but are not meant to be
interpreted as being stronger recommendations than Level 1 or 2 recommendations.
C.Agnello SE 0237
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 241 of 569 PageID S19
KDIGO Living Kidney Donor Work Group
#:
435
TABLE 5.
Determinants of strength of a recommendation
Factors Comments
Balance between desirable and undesirable effects The larger the difference between the desirable and undesirable effects, the more likely a strong recommendation
is warranted. The narrower the gradient, the more likely a weak recommendation is warranted
Quality of the evidence The higher the quality of evidence, the more likely a strong recommendation is warranted
Values and preferences The more variability in values and preferences, or the more uncertainty in values and preferences, the more likely a
weak recommendation is warranted. Values and preferences were obtained from the literature where possible.
or were assessed in the judgment of the work group where robust evidence was not identified
Costs (resource allocation) The higher the costs of an intervention—that is, the more resources consumed—the less likely a strong
recommendation is warranted
be attributed to numerous reasons as stated in Table 7.11 Limitations of Systematic Review Approach
When the WG determined that there was evidence for a rec- Although the literature searches were intended to be com-
ommendation that was outside the scope of the ERT review, prehensive, they were not exhaustive. Hand searches of
this was indicated in the rationale for that recommendation. journals were not performed, and review articles and text-
It is also important to note that when recommendations from book chapters were not systematically searched. However,
other KDIGO WGs were modified for the purpose of this any important studies known to domain experts that were
guideline, the prior grading was provided in the rationale missed by the electronic literature searches were added to re-
but the adapted recommendations were not graded so as to trieved articles and reviewed by the WG.
limit grading only to statements derived from the de novo
systematic review performed for this guideline.
Review of Guideline Development Process
Developing the Recommendations Several tools and checklists have been developed to assess
the quality of the methodological process for systematic re-
Draft recommendation statements were developed by the
view and guideline development. These include the Appraisal
WG cochairs and WG members with input from all WG
of Guidelines for Research and Evaluation (AGREE 2) cri-
members. The health risks and benefits associated with each
teria,12 the Conference on Guideline Standardization (COGS)
recommendation were considered when formulating the
checklist,13 and the Institute of Medicine’s recent Standards
guideline, as well as information on patient preferences when
for Systematic Reviews14 and Clinical Practice Guidelines
available. Recommendation statements were revised in a
We Can Trust.15 Table 8 displays the criteria which corre-
multi-step process during teleconferences and 2 face-to-
spond to the COGS checklist and how each one is addressed
facemeetings, as well as in subsequent emails. All WG mem-
in this guideline.
bers provided feedback on initial and final drafts of the
recommendations.
Public Comment and Revision
Format for Recommendations A draft of the guideline was distributed for open public re-
Each chapter contains one or more specific recommenda- view in November 2015. The guideline was revised into final
tions. When pertinent evidence was available in the system- form by WG cochairs and members. A point-by-point re-
atic review, the strength of recommendation is indicated as sponse to all public comments is available online (Supple-
level 1 or level 2 and the quality of the supporting evidence mental Appendix E, SDC, http://links.lww.com/TP/B433).
is shown as A, B, C, or D. When the ERT search parameters All WG members approved the final version of the guideline.
did not identify evidence from eligible studies pertinent to a
recommendation, the statement is ungraded. In all cases, rec-
ommendation statements and grades (if applicable) are CHAPTER 1: GOALS OF EVALUATION,
followed by rationale text summarizing the key points of FRAMEWORK FOR DECISION-MAKING,
the evidence base and the judgments supporting the recom- AND ROLES AND RESPONSIBILITIES
mendations. Research recommendations for future work to The ERT search parameters did not identify evidence from el-
help resolve current uncertainties are also outlined at the con- igible studies pertinent to the recommendations in chapter 1 and
clusion of each chapter. therefore the following recommendations are “Not Graded.”
TABLE 6.
Final grade for overall quality of evidence
Grade Quality of evidence Meaning
A High We are confident that the true effect lies close to that of the estimate of the effect
B Moderate The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
C Low The true effect may be substantially different from the estimate of the effect
D Very low The estimate of effect is very uncertain, and often will be far from the truth
C.Agnello SE 0238
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 242 of 569 PageID #:
S20 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 436 www.transplantjournal.com
TABLE 7.
Reasons why many ungraded recommendations are issued in this guideline
The ERT’s inclusion criteria (Table 2) are necessarily stringent given the limited time and resources for collecting and summarizing available evidence. As such,
ungraded recommendations are issued:
• For topics that are not part of the ERT’s inclusion criteria or when evidence lies outsides ERT’s search yield
• In areas where the work group does not believe evidence is available (eg, recommendations grounded in ethics) or for which no there is no reasonable
alternative (ie, based on common sense). Such recommendations may be deemed necessary because the work group considers such “good practice
statements” essential especially when net benefit is great and unequivocal.
• In areas for which systematic review is not applicable (eg, monitoring intervals, counseling)
• Based on indirect evidence (eg, extrapolation of evidence from studies in general population)
• When adaped from prior KDIGO guidelines and extrapolated from different populations of interest (eg, general population or CKD population from KDIGO CKD Guideline)
CKD, chronic kidney disease; ERT, evidence review team; KDIGO, Kidney Disease: Improving Global Outcomes.
Goals and Principles of Evaluation candidate’s postdonation risk is below the transplant
program’s acceptable risk threshold, the candidate makes
1.1: The donor candidate’s willingness to donate a kidney the decision whether or not to proceed with donation.
voluntarily without undue pressure should be verified. 1.14: If a donor candidate is not acceptable, the transplant
1.2: The benefits and risks of kidney donation should be program should explain the reason for nonacceptance
assessed for each donor candidate. to the donor candidate.
1.3: The decision to accept or exclude a donor candidate 1.15: Transplant programs should protect donor candidate’s
should follow transplant program policies. privacy regarding the evaluation, including all consider-
1.4: Donor candidate decision-making should be facilitated ations in the decision to donate or not.
through education and counseling on individualized
risks and benefits, methods to minimize risks, and the Roles and Responsibilities
need for postdonation follow-up.
1.5: For an accepted donor candidate, a plan for donation 1.16: A multidisciplinary transplant program team knowl-
care and follow-up should be formulated to minimize edgeable in kidney donation and transplantation should
risks of donation. evaluate, care for, and formulate a plan for donor care
1.6: For an excluded donor candidate, a plan for any needed including long-term follow-up.
care and support should be formulated. 1.17: Transplant programs should minimize conflict of inter-
est by providing at least one key team member not in-
Framework for Decision-Making volved in the care or evaluation of the intended
recipient who evaluates the donor candidate and partic-
1.7: The donor candidate, the intended recipient, and the trans- ipates in the determination of donor acceptance.
plant program must all agree with the decision to proceed 1.18: Transplant programs should conduct as efficient a donor
with donation in concordance with transplant program evaluation as possible, meeting the needs of donor candi-
policies and informed consent. dates, intended recipients and transplant programs.
1.8: Transplant program policies must be defensible based
on current understanding of the risks and benefits of
kidney donation, and should apply to all donor candi- RATIONALE
dates evaluated at the center.
1.9: Each transplant program should establish policies de- Goals and Principles of Donor Evaluation
scribing psychosocial criteria that are acceptable for Evaluation of candidates for living kidney donation re-
donation, including any program constraints on ac- quires balancing ethical principles of autonomy, benefi-
ceptable relationships between the donor candidate cence, nonmaleficence, voluntarism and justice.16 Determining
and the intended recipient. acceptability or nonacceptability of donor candidates re-
1.10: All donor candidates should be evaluated using the same quires an assessment of their potential risks and anticipated
criteria, regardless of whether donation is directed to-
benefits of donation, independent of intended recipient is-
wards a designated recipient.
1.11: Each transplant program should establish policies de- sues. Donation must be voluntary (autonomous), and the
scribing medical criteria that are acceptable for donation, motivation for donation must be altruistic – to satisfy a
addressing when possible, numeric thresholds for short- well-considered desire to help another person. There must
term and long-term postdonation risks above which the be protection from undue pressure or coercion at every step
transplant program will not proceed with donation. Risks in the evaluation and donation process, including the option
should be expressed as absolute rather than relative risks. to confidentially withdraw from the evaluation or to decline
1.12: When possible, transplant programs should provide to donate at any time with the full support of the transplant
each donor candidate with individualized quantitative program.17 In addition to these ethical principles, protection
estimates of short-term and long-term risks from dona- of patient privacy must be ensured. However, information re-
tion, including recognition of associated uncertainty, in
garding donor lifestyle, exposures or medical history that in-
a manner that is easily understood by donor candidates.
1.13: Transplant programs should evaluate donor candidate crease the risk for transmission of disease may need to be
risks in comparison to predetermined thresholds for ac- disclosed to the intended recipient for donation and trans-
ceptance. If a donor candidate’s postdonation risk is plantation to proceed; donor candidates should be given
above the transplant program’s acceptable risk thresh- the opportunity to withdraw if they do not consent to sharing
old, the risk is not acceptable for donation. If a donor relevant personal health information in such circumstances.
C.Agnello SE 0239
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 243 of 569 PageID S21
KDIGO Living Kidney Donor Work Group
#:
437
TABLE 8.
The Conference on Guideline Standardization (COGS)13 checklist for reporting clinical practice guidelines
Discussed in KDIGO Clinical Practice Guideline on the
Topic Description Evaluation and Care of Living Kidney Donors
(1) Overview material Provide a structured abstract that includes the guideline’s Abstract and Methods for Guideline Development
release date, status (original, revised, updated), and print
and electronic sources
(2) Focus Describe the primary disease/condition and intervention/ This guideline seeks to formalize the framework for decision making
service/technology that the guideline addresses and evaluation process for living kidney donor candidates and
Indicate any alternative preventative, diagnostic or to define the optimal postdonation follow-up care
therapeutic interventions that were considered during
development
(3) Goal Describe the goal that following the guideline is expected This Clinical Practice Guideline is intended to assist the practitioner
to achieve, including the rationale for development of a in evaluating living kidney donor candidates and optimizing the
guideline on this topic care for donors and their quality of life
(4) User/setting Describe the intended users of the guideline (eg, provider Target audience is practicing nephrologists, transplant physicians
types, patients) and the settings in which the guideline is and other allied health professionals who work in the setting
intended to be used of living kidney transplantation
(5) Target population Describe the patient population eligible for guideline Living kidney donors
recommendations and list any exclusion criteria
(6) Developer Identify the organization(s) responsible for guideline Organization: KDIGO
development and the names/credentials/potential Names/credentials/potential conflicts of interest of individuals
conflicts of interest of individuals involved in the involved in the guideline’s development are disclosed in the
guideline’s development Biographic and Disclosure Information
(7) Funding source/sponsor Identify the funding source/sponsor and describe its role This guideline is supported by KDIGO with contributions from
in developing and/or reporting the guideline Canadian Blood Services, Canadian Society of Nephrology,
Disclose potential conflict of interest Minneapolis Medical Research Foundation, and The
Transplantation Society
(8) Evidence collection Describe the methods used to search the scientific Topics were triaged either to a) systematic review, b) systematic
iterature, including the range of dates and databases search followed by narrative summary (eg, prior living kidney
searched, and criteria applied to filter the retrieved evidence donor guidelines), or c) narrative summary. The search was
updated through September 2014 and supplemented by articles
identified by work group members through January 2017.
We also searched for pertinent existing guidelines and
systematic reviews
(9) Recommendation Describe the criteria used to rate the quality of evidence Quality of evidence and strength of recommendations were graded
grading criteria that supports the recommendations and the system for following the GRADE approach (Tables 4 and 6). The work group
describing the strength of the recommendations. could provide general guidance in ungraded statements
Recommendation strength communicates the importance
of adherence to a recommendation and is based on both
the quality of the evidence and the magnitude of
anticipated benefits and harms
(10) Method for Describe how evidence was used to create recommendations, For systematic review topics, summary tables and evidence
synthesizing evidence eg, evidence tables, meta-analysis, decision analysis profiles were generated
(11) Prerelease review Describe how the guideline developer reviewed and/or tested The guideline had undergone external public review in
the guidelines before release November to December 2015. Public review comments
were compiled and fed back to the work group, which
considered the comments in its revision of the guideline
(12) Update plan State whether or not there is a plan to update the guideline The requirement for an update will be assessed on an ongoing
and, if applicable, an expiration date for this version basis from the publication date for potential important new
of the guideline evidence that may lead to changes to the recommendations
(13) Definitions Define unfamiliar terms and those critical to correct application Abbreviations and Acronyms
of the guideline that might be subject to misinterpretation
(14) Recommendations State the recommended action precisely and the specific This guideline contains recommendations for evaluation of
and rationale circumstances under which to perform it kidney donor candidates and postdonation follow-up care.
Justify each recommendation by describing the linkage Each recommendation builds on a supporting rationale with
between the recommendation and its supporting evidence evidence tables if available. The strength of the recommendation
Indicate the quality of evidence and the recommendation and the quality of evidence are provided in parenthesis within
strength, based on the criteria described in Topic 9 each recommendation, where applicable
Continued next page
C.Agnello SE 0240
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 244 of 569 PageID #:
S22 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 438 www.transplantjournal.com
TABLE 8. (Continued)
Discussed in KDIGO Clinical Practice Guideline on the
Topic Description Evaluation and Care of Living Kidney Donors
(15) Potential benefits Describe anticipated benefits and potential risks associated The benefits and harm for each recommendation are provided in
and harms with implementation of guideline recommendations summary tables and summarized in evidence profiles where
applicable. The estimated balance between potential benefits and
harm was considered when formulating the recommendations
(16) Patient preferences Describe the role of patient preferences when a The inclusion of patient values and preferences is clearly
recommendation involves a substantial element of articulated where appropriate
personal choice or values
(17) Algorithm Provide (when appropriate) a graphical description of the No overall algorithm
stages and decisions in clinical care described by
the guideline
(18) Implementation Describe anticipated barriers to application of the Review criteria were not suggested because implementation with
considerations recommendations prioritization and development of review criteria must proceed
Provide reference to any auxiliary documents for providers locally. Furthermore, most recommendations are discretionary,
or patients that are intended to facilitate implementation requiring substantial discussion among stakeholders before they
Suggest review criteria for measuring changes in care can be adopted as review criteria
when the guideline is implemented Research recommendations were also outlined to address current
gaps in the evidence base
GRADE, Grading of Recommendations Assessment, Development, and Evaluation; KDIGO, Kidney Disease: Improving Global Outcomes.
Preservation of donor candidate autonomy and minimiza- decision making between donor candidates and their trans-
tion of short-term and long-term risks are high priorities in plant professionals.16,19-21
the practice of living donation. The transplant program has An important advance is quantification of the combined im-
the responsibility to disclose anticipated risks and benefits pact of all of a donor candidate’s predonation demographic
to the donor candidate and intended recipient, tailored when (eg, age, sex, and race) and health characteristics at the time
possible for the characteristics of each donor candidate.18 of evaluation (eg, kidney function, blood pressure [BP], body
The donor candidate must have adequate time to make an in- mass index [BMI], and so on) on the risk of serious adverse
formed decision and must accept the need for long-term outcomes after donation. Serious postdonation adverse out-
follow-up. The transplant program must offer support for comes can be surgical, medical or psychosocial, and may oc-
decision-making through education and the informed consent cur during the perinephrectomy period, in a fixed period of
process, and has a responsibility to confirm that the donor long-term follow-up (eg, 15 years after donation), or for the
candidate understands the likely risks and benefits of dona- remaining lifespan of the donor.
tion. The transplant program makes the final determination As described within this overall framework, a transplant
of acceptance of the donor candidate, based on the program’s program can use various methods to establish its threshold
policies. The transplant program must have a mechanism for for acceptable outcomes after kidney donation. For example,
resolving disagreement among team members regarding ac- if a transplant program decides a lifetime postdonation risk
ceptability of donor candidates that avoids conflicts of interest. of kidney failure of up to 5% is acceptable, and if a candi-
date’s projected risk is estimated to be above this threshold,
A Quantitative Framework for Equitable the program should decline this candidate as a donor. Donor
Decision Making candidate autonomy does not overrule medical judgment
There will always be risks to living kidney donation. A and transplant professionals are ethically justified to decline
central objective of donor candidate evaluation and selection a donor candidate when they believe the risk of poor
is to minimize risks of short-term and long-term adverse postdonation outcomes is too high.22 A poor outcome can
outcomes after donation, and to ensure the risks are ac- have a very negative impact on the donor, on their recipient,
ceptable. Consistent, transparent and defensible decision- and on public opinions about living donation.
making to accept or decline a living kidney donor candidate Each transplant program should strive to develop and
has been limited by the lack of an evidence-based means communicate a quantitative threshold of “acceptable risk”
to provide individualized, quantitative estimates of post- for each serious postdonation adverse outcome it wishes to
donation risk. Prior living kidney donor guidelines describe avoid. Thresholds should be both evidence-based and
postdonation risk in relation to single predonation charac- consensus-based, and there are various sources of evidence
teristics assessed in isolation, and generally agree on the sin- and processes by which consensus can be achieved. Once
gle predonation characteristics that are associated with established, a threshold should be applied consistently
higher risks of poor postdonation outcomes. However, and transparently for all donor candidates evaluated by a
prior guidelines often differ on the recommended specific program (unless subsequently revised). When a donor candi-
threshold for a characteristic that should be used to accept date’s estimated risk is below the acceptable risk threshold,
or decline living donor candidates, and are unclear about the transplant program should accept a donor candidate,
how values above or below the threshold alter the risk of and it should be the candidate’s decision whether or not to
postdonation outcomes. There have been several calls to im- proceed with living kidney donation after being informed
prove the current status quo, and to support better shared of the risks. When a candidate’s estimated risk is above the
C.Agnello SE 0241
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 245 of 569 PageID S23
KDIGO Living Kidney Donor Work Group
#:
439
acceptable threshold, the transplant program is justified in 60 to 85 years at donation) did not differ statistically from
declining the candidate and can ground its decision in a a group of younger donors in their operative time, intraop-
quantitative framework (Figure 3). erative blood loss, and length of hospital stay.26 In both re-
During the development of this guideline we have ad- views, groups of selected obese donors (mean BMI of
vanced concepts and analyses to support this framework 34.5 kg/m2; range 32-39 kg/m2) did not differ statistically
and approach. Here we discuss certain serious adverse out- from groups of nonobese donors in their rates of perioper-
comes and their amenability to quantitative risk estimation. ative complications, operative time, blood loss and length
We focus particularly on the postdonation development of of hospital stay.26,27
kidney failure requiring dialysis or transplantation because Since then a large US study examined predonation charac-
it is a central outcome of a donor candidate’s long-term risk. teristics associated with a higher risk of donor nephrectomy-
Finally, we describe the path for future work necessary to related complications (as assessed through administrative
strengthen this framework, which includes the need for addi- data rather than adjudication, using a composite outcome
tional data. of digestive, respiratory, procedural, urinary, hemorrhage,
infectious or cardiac complications).28 In this study, where
Perinephrectomy Outcomes each donor candidate characteristic was considered by itself
The incidence of perioperative death after living kidney (rather than as a combination of characteristics), complica-
donation is low. The 90-day all-cause mortality in a recent tion rates were higher in men versus women (9.6% vs
United States (US) study of 80 347 donors was reported to 7.2%); among African Americans (10.4%) and whites
be approximately 1 in 3000 (0.03%) based on 25 deaths.23 (8.7%) compared with other racial groups (6.3%); among
Similar rates have also been reported in other studies.24,25 donors without private insurance (8.5%) compared with
Given the low incidence of perioperative mortality, estimates those who had private insurance (7.3%); and among donors
for predonation characteristics that alter the risk of perioper- with hypertension (17.7%) compared with those without hy-
ative death are imprecise. For example, in this same study,23 a pertension (7.9%).
predonation history of hypertension was associated with a 1 A subsequent study integrated national US donor registry
in 270 risk of 90-day mortality. However, this estimate was data from 2008 to 2012 with administrative records from a
based only on 2 observed deaths, and the estimate would consortium of 98 academic hospitals and found that 16.8%
have substantially changed if 1 more or less death was ob- of donors experienced a diagnosis or procedure for a
served; the 95% CI for the estimate was also wide, ranging perinephrectomy complication, most commonly gastroin-
from 1 in 75 to 1 in 2220. Thus, even if a transplant program testinal (4.4%), bleeding (3.0%), respiratory (2.5%), and
defines an acceptable risk threshold for perinephrectomy surgical/anesthesia-related injuries (2.4%).29 Major compli-
mortality (for example, an incidence less than 1 in 1000), it cations, defined as Clavien severity level 4 or 5, were identi-
will be difficult at this time to reliably determine a given do- fied in 2.5% of donors. After adjustment for demographic,
nor candidate’s estimated risk of this outcome according to clinical (including comorbidities), procedure, and center
their profile of predonation characteristics. factors, compared with white donors, African Americans
With respect to perioperative complications, the ERT iden- had significantly higher risks (P < 0.05) of experiencing
tified 2 systematic reviews that examined perinephrectomy any complication (18.2% vs 15.5%) and of experienc-
outcomes in relation to demographic and health character- ing major complications (3.7% vs 2.2%). Other significant
istics of accepted donors. The ERT rated the quality of this correlates of major complications included obesity, pre-
evidence as very low (Evidence Report Tables 6 and 7, donation blood disorders, psychiatric conditions, and ro-
SDC, http://links.lww.com/TP/B434). In one review, a botic nephrectomy, while greater annual hospital volume
group of selected older donors (mean age, 66 years; range, predicted lower risk.
FIGURE 3. Framework to accept or decline donor candidates based on a transplant program’s threshold of acceptable postdonation risk. The
decision by the transplant program to accept or decline a donor candidate is grounded on whether an individual’s estimated postdonation risk
is above or below the threshold set (dotted line) by the transplant program. The threshold may vary across transplant programs, but the same
threshold should apply to all donor candidates at each program. For example, candidate A (green) would be acceptable because the estimated
projected postdonation risk is far below the threshold. Candidate B (yellow) could be accepted with caution because the estimated projected
postdonation risk is close but below the threshold, and candidate C (red) would be unacceptable because the estimated postdonation
projected risk is far above the threshold.
C.Agnello SE 0242
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 246 of 569 PageID #:
S24 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 440 www.transplantjournal.com
As future data become available, it may become possible less than 2 decades rather than for their lifetime).30 The risk
for transplant programs to estimate the risk of well-defined, of kidney failure after donation is nonlinear, and is expected
serious perioperative complications according to a donor to be higher later (≥10 years) than earlier (<10 years) after
candidate’s individual profile of baseline characteristics, donation.31 When the WG was convened, 2 recent studies
and to compare these estimates to a threshold of acceptable reported that the risk of kidney failure is higher in donors
risk to inform donor acceptance decisions. compared with risk among nondonors with similar base-
line demographics. The ERT assessed the quality of evi-
Long-term Outcomes dence from these 2 studies as moderate (Table 2 of Slinin
Donating a kidney is a decision with lifetime implications et al3).30,32 Available data suggest that the average donation-
for the donor. While there are many outcomes to consider af- attributable risk of kidney failure is approximately 27 per
ter kidney donation, a central outcome directly related to 10 000 (0.3%) at 15 years,30 but there is substantial uncer-
having one kidney removed is the long-term risk of develop- tainty in the estimate, and there are not sufficient data to pro-
ing kidney failure requiring dialysis or transplantation, com- ject lifetime donation-attributable risk. Furthermore, the
monly referred to as ESKD. Donor candidates often have a extent to which donation-attributable risk varies according
good understanding of the health effects of kidney failure, to individual health characteristics is not known,33,34 al-
as their reason to donate is to treat the kidney failure of their though available evidence suggests there is higher donation-
intended recipient. For these reasons, we have grounded a attributable risks in some subgroups, such African Americans
quantitative framework for medical evaluation and accep- compared with white donors.30
tance of donor candidates on the long-term risk of post- Existing large population-based studies can help estimate
donation kidney failure. the long-term risk of treated kidney failure in the absence of
Each donor candidate has a long-term risk (cumulative donation, based on a candidate’s predonation health char-
incidence) of developing kidney failure that is influenced by acteristics. Furthermore, if the risk of kidney failure attrib-
the combination of risks conferred by their demographic utable to donation becomes more precisely understood
and health characteristics at the time of evaluation plus risk in relation to an individual’s profile of baseline characteris-
attributable to donation (Figure 4). Demographic character- tics, then demographic-related, health status related, and
istics include age, sex, and race. Health characteristics in- donation-attributable risks can be aggregated to project in-
clude glomerular filtration rate (GFR), albuminuria, BMI, dividualized estimates of long-terms risks of postdonation
BP, diabetes status, smoking history, family history of kidney kidney failure.
disease, and other factors. The risk attributable to donation To help advance this paradigm, we enlisted the help of the
may also vary according to demographic and health char- CKD-Prognosis Consortium (CKD-PC) to develop a tool to
acteristics. Minimizing the lifetime risk of kidney failure in project the 15-year and lifetime incidence of kidney failure
accepted donors is important to safeguard the practice, re- in the absence of donation based on demographic and health
gardless of the degree to which it can be established that characteristics at the time of evaluation in low-risk persons
donation contributed to the risk of kidney failure. from large population cohorts. CKD-PC is a research group
Challenges to determining the postdonation lifetime risk of composed of investigators who analyze large cohort data
kidney failure based on current studies include limitations of and perform collaborative meta-analyses. The methods and
study follow-up (the largest studies followed most donors for results of these analyses are reviewed briefly here and
FIGURE 4. Framework to accept or decline donor candidates based on a transplant program’s threshold of acceptable projected lifetime risk
of kidney failure, quantified as the aggregate of risk related to demographic and health profile and donation-attributable risks. The decision by
the transplant program whether to accept or decline a donor candidate is grounded on the candidate's estimated postdonation lifetime risk,
including estimated risk in the absence of donation (risk related to demographic and health characteristics as denoted in blue and beige, re-
spectively) and estimated risk attributable to donation (brown). BMI, body mass index; GFR, glomerular filtration rate.
C.Agnello SE 0243
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 247 of 569 PageID S25
KDIGO Living Kidney Donor Work Group
#:
441
presented in expanded form in a separate publication.7 To limitations in precision of risk estimates and uncertainty in
project the estimated long-term incidence of kidney failure donation-attributable risk. These models should be refined
among persons who do not donate a kidney according to through further research to improve the precision and gener-
10 demographic and health characteristics, risk associations alizability of predonation risk estimates and to incorporate
were derived from a meta-analysis of 7 general population estimates of indivdualized risk attributable to donation.
cohorts. Relative risks were calibrated to the population-level We endorse a quantitative framework for donor candi-
annual incidence of ESKD in the United States, derived from date evaluation and acceptance centered on lifetime risk of
actual ESKD incidence and mortality data collected by the US postdonation kidney failure (Table 9). For example, if a
Renal Data System and overall mortality data from the US transplant program sets the acceptable lifetime post-
Census.35 Fifteen-year projections were compared with the donation ESKD risk threshold at 5%, and assumes a donation-
observed risk among 52 998 living kidney donors in the attributable RR of 3.5 to 5.3 according to sex and race, then
United States. For estimation of relative risks related to the acceptable predonation lifetime ESKD risk threshold
health characteristics, a total of 4 933 314 participants from would be approximately 1.0-1.5. This strategy enables
7 cohorts were followed for a median of 4 to 16 years. For a decision-making based on a more comprehensive and inte-
40-year-old person with health characteristics similar to grated assessment of risk factors than is currently practiced,
those of age-matched kidney donors, the 15-year projec- but application of the currently available online tool at this
tions of ESKD risk in the absence of donation varied accord- time requires clinician insight and interpretation.37 Cur-
ing to race and sex; the risk was 0.24% among black men, rently, there remains uncertainty in lifetime risk estimates,
0.15% among black women, 0.06% among white men, particularly for younger donor candidates, donors from de-
and 0.04% among white women. Risk projections were veloping countries, and ethnicities other than black or white
higher in the presence of lower eGFR, higher albuminuria, race. At this time, transplant programs and donor candidates
hypertension, current or former smoking, diabetes, and obe- may consider other factors in their acceptance criteria for
sity. In the model-based lifetime projections, the risk of living kidney donation in addition to quantitative risk esti-
ESKD was highest among persons in the youngest age mates. We see this work as starting point, and advocate
group, particularly among young black persons. The strongly for continued efforts to improve the precision, tai-
15-year observed postdonation risks among kidney donors loring and generalizability of predonation and postdonation
in the United States were 3.5 to 5.3 times as high as the risk estimates. Quantifying donation-attributable risk ac-
projected risks in healthy persons in the absence of dona- cording to predonation demographic and health profile is a
tion, according to sex and race. leading priority for future research, and we will update the
This study has important limitations.36 First, the projec- online tool once estimates are available.
tions were calibrated to historical incidence rates of ESKD In summary, we advocate for a quantitative paradigm
from US population data. Annual incidence was derived with wherein transplant programs accept or decline donor candi-
the use of life-table methods, which assume a constant age-, dates using the strongest evidence-based criteria currently
sex-, and race-specific incidence of ESKD over periods of de- available to simultaneously consider a profile of risk factors
cades and a static population substructure. Second, informa- (demographic and health characteristics at evaluation and
tion on certain health characteristics of interest was not risk attributable to donation) and support consistent, trans-
available, including heritable and environmental factors. parent and defensible decisions. Ongoing efforts are needed
The estimates reflect population averages for unmeasured to strengthen and advance this paradigm, including incor-
characteristics. Donor candidates with a family history of poration of data from cohorts observed for longer periods
kidney disease (especially younger candidates with such his- of time (ideally over the lifetime) and from diverse coun-
tory) would be expected to have a higher risk of ESKD than tries; estimation of risks related to genetic and familial fac-
projected. Third, the relative risk estimates were based on tors; and quantification of donation-attributable risks
low-risk cohorts followed for a median of 4 to 16 years,
based on an assumption of proportional hazards and after
testing for nonproportionality. The analysis does not in- TABLE 9.
clude untreated low GFR as an outcome, a condition that Approaches to implementation of a quantitative framework
is more common among older persons, nor did it assess for donor candidate medical evaluation and acceptance
the risk of other outcomes, such as hypertension or pre- centered on lifetime risk of kidney failure
eclampsia, that have been linked to kidney donation. Fi-
nally, the analysis did not estimate the age at which ESKD (1) Use the online tool (http://www.transplantmodels.com/esrdrisk/) to estimate
would be expected develop in a donor candidate or the du- the projected lifetime risk of kidney failure in the absence of donation
ration of ESKD before death. according to baseline demographic and health characteristics included
The resulting risk models were incorporated into an online in the online tool
risk prediction tool for 15-year and lifetime ESKD risk (2) Multiply the projected predonation risk by the best available estimate
(http://www.transplantmodels.com/esrdrisk/). Although the for donation-attributable risk to obtain the projected postdonation risk.
risk tool was developed specifically for the United States, For example, Grams et al7 report a relative risk of 3.5 to 5.3 for 15-y
the methods used may be adapted to other countries with end-stage kidney disease risk, according to sex and race
the availability of local data sources. The WG endorses (3) Compare the projected risk estimate to the program’s postdonation
use of the online tool as the foundation for a new evalua- threshold of acceptable risk
tion framework centered on simultaneous consideration (4) Exercise caution when there is concern that the individual has risk factors
of multiple demographic and health characteristics to predict not captured in the online tool (eg, familial or genetic risk) and for
long-term risk of an important outcome, while recognizing younger candidates
C.Agnello SE 0244
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 248 of 569 PageID #:
S26 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 442 www.transplantjournal.com
TABLE 10.
Roles and responsibilities of participants in donor candidate identification, evaluation, care, and follow-up
Entity Responsibilities
General nephrologist/dialysis unit/advanced chronic • Educate recipient candidates regarding early referral, preemptive and living donor
kidney disease clinic transplantation options and resources for identifying donor candidates
Transplant program • Educate recipient candidates regarding early referral, preemptive and living donor
transplantation options
• Educate donor candidates regarding all phases of the donation process including evaluation,
surgery, postdonation follow-up, expected risks and outcomes, and existing uncertainties
Recipient candidate health insurance carrier • Provide coverage for costs related to recipient candidate evaluation and transplantation,
including coverage of donor candidate evaluation and treatment costs
Donor/donor candidate health insurance carrier • Educate donor candidates regarding any anticipated out-of-pocket expenses related
to evaluation and donation processes
• Educate donor candidates regarding coverage for postdonation complications, both short-term
and long-term after donation
Donor/donor candidate primary care physician • Support donor candidates in their desire for information to make informed decisions
• Participate in predonation and early postdonation care as needed
• Participate in long-term care after donation
Donor/donor candidate physician/nephrologist • Evaluate donor candidates without influence from recipient considerations
• Oversee evaluation testing
• Provide education regarding all phases of the donation process including postdonation follow-up
• Participate in donor candidate selection
• As needed, participate in care during the surgical hospitalization, in the early postdonation period,
and long-term after donation, including serving as resource for primary providers
Donor surgeon • Evaluate donor candidates for surgical risks and plan surgical approach
• Provide education on the surgical procedure, risks and expected recovery
• Participate in donor candidate selection
• Provide care during surgery and perioperative period, and as needed postdonation
Nurse coordinator • Educate donor candidates on recipient candidate treatment options and phases of the
donation process
• Facilitate and oversee completion of the evaluation
• Assist with arranging surgery and inpatient care
• Arrange and oversee postoperative care, and coordinate a plan for postdonation follow-up
Dietitian • Review dietary habits and metabolic status including measures of obesity when needed
• Provide guidance for nutritional treatment if indicated, including recommendations to address obesity
Social worker/psychologist/psychiatrist • Perform donor candidate psychosocial evaluation including assessment of motivation
• Educate donor candidates on recipient candidate treatment options
• Provide donor candidates with information and support services related to donation, including
information on resources that may be available to assist with donation-related expenses
• Discuss potential adverse outcomes including loss of income because of donation, donation-related
complications, or failure of the transplant. Assess the ability of donor candidates to cope with
adverse outcomes
• Support informed donation decisions
• Assist donors with planning support around the time of donation and creation of a long-term
follow-up plan
Independent living donor advocate a • Verify that donor candidates have information needed to make a voluntary and informed decision
on whether or not to donate
• Verify consent for donation
• Function independently from the recipient candidate’s team
• Advocate for the rights of donor candidates and donors
Regulatory and oversight agencies • Create policies for minimum standards of donor candidate informed consent, evaluation,
care and donor follow-up
Donor/donor candidate • Agree to required psychosocial and medical evaluation
• Agree to disclosure of required personal health information to intended recipient with regard
to risk of disease transmission when necessary, or to withdraw from donation
• Agree to required lifestyle modifications to reduce risks of donation and promote long-term good health
• Agree to participate in postdonation follow-up
a
The role of the independent donor advocate may be served by another team member as long as criteria for independence and advocacy functions are satisfied.
C.Agnello SE 0245
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 249 of 569 PageID S27
KDIGO Living Kidney Donor Work Group
#:
443
according to multiple predonation health characteristics. CHAPTER 2: INFORMED CONSENT
The scope of the current guideline is focused on donor
The ERT search parameters did not identify evidence from
safety, and excludes consideration of recipient outcomes
eligible studies pertinent to the recommendations in chapter 2
based on donor characteristics. However, we appreciate
and therefore the following recommendations are “Not
that a donor candidate’s profile of predonation character-
Graded.”
istics may also have important impacts on posttransplant
recipient outcomes, and that topic also warrants future Process of Informed Consent
consideration.
2.1: Informed consent for donation should be obtained from
the donor candidate in the absence of the intended recip-
Roles and Responsibilities ient, family members and other persons who could influ-
Transplant programs bear the primary responsibility for ence the donation decision.
evaluation, care and follow up of living kidney donor candi-
dates and donors. The main responsibilities of the transplant Capacity for Decision Making
program are to establish and maintain policies and a team of 2.2: The donor candidate’s capacity to provide informed con-
professionals to provide care according to policies. However, sent (ie, ability to understand the risks, benefits and
many other entities share in these responsibilities (Table 10). consequences of donation) should be confirmed before
The decision to donate should be regarded as a shared re- proceeding with evaluation and donation.
sponsibility between the donor candidate, the donor can- 2.3: Substitute decision makers should not be used on behalf
didate’s primary physician, and the transplant program. of a donor candidate who lacks the capacity to provide
Transplant programs and the organizations that regulate informed consent (eg, children or those who are mentally
transplant practice should: challenged), except under extraordinary circumstances
and only after ethical and legal review.
• Evaluate and disclose risks to the best of currently available
knowledge Content of Disclosure
• Respect the donor candidate’s autonomy, including auton-
2.4: Protocols should be followed to provide each donor can-
omy to take risk, within a program’s/regulators’ upper bound
didate with information on:
of acceptable risk
• Embrace a long-term relationship with the donor, because • The processes of evaluation, donor acceptance, and
some risks are uncertain or evolving follow-up
• The types of information that may be discovered during
the evaluation, and what the transplant program will do
RESEARCH RECOMMENDATIONS with such information
• Individualized risks, benefits and expected outcomes
• Strengthen and refine estimates of long-term projected pre- of the donor evaluation, donation, and postdonation
donation and postdonation risks of kidney failure, including health, including a discussion of the uncertainty in some
incorporation of data from cohorts observed for longer pe- outcomes
riods of time (ideally over the lifetime), from different coun- • Treatment alternatives available to transplant candi-
tries and regions, and estimates of risk related to familial, dates, and average expected outcomes
genetic (eg, apolipoprotein L1 [APOL1]), and other factors • How personal health information will be handled
(eg, birth weight). • Availability of transplant program personnel for support
• Engage in consensus-building activities among transplant pro-
fessionals, donors and recipients to help establish uniform Comprehension of Disclosed Information
threshold of unacceptable risk. Strategies that may help in-
form consensus include: 2.5: The donor candidate’s understanding of the relevant in-
◯ Estimate the long-term risk of kidney failure among previ- formation on the risks and benefits of donation should
ously accepted donors, such as those captured in large na- be confirmed before proceeding with donation.
tional databases.
◯ Estimate long-term risk of kidney failure based on donor ac- Voluntarism
ceptance criteria specified in prior guidelines.
◯ Evaluate implications of racial variation in long-term risk of 2.6: Donor candidates should have adequate time to consider
kidney failure exceeding possible thresholds for acceptable information relevant to deciding whether they wish to do-
risk on opportunities for living donation. Develop strategies nate or not.
to promote equitable access to kidney transplantation with- 2.7: A donor candidate’s decision to withdraw at any stage of
out placing certain donors at unacceptable risk. the evaluation process should be respected and supported
in a manner that protects confidentiality.
• Determine the best methods of communicating individualized
2.8: A donor candidate who decides not to donate and has
risks to donor candidates and their intended recipients so
difficulty communicating that decision to the intended
that the information is understood and supports patient
recipient should be assisted with this communication
decision-making.
by the transplant program.
• Explore application of individualized risk estimates to guide
predonation support and counseling (eg, target predonation
BMI levels) to minimize the risk of adverse postdonation
RATIONALE
outcomes.
• Develop tools to predict risks of adverse short- and long-term Obtaining informed consent to be evaluated as a living
psychosocial outcomes and a broader spectrum of medical kidney donor candidate, and informed consent to undergo
outcomes according to predonation characteristics. living kidney donation, are processes rather than a discreet
C.Agnello SE 0246
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 250 of 569 PageID #:
S28 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 444 www.transplantjournal.com
event. The transplant program has a responsibility to estab- and is able to communicate their decisions based on accurate
lish that the donor candidate is capable of understanding comprehension of the information disclosed to them.2,18
the relevant information (capacity), is adequately informed Local laws and guidelines should be followed regarding
of the likely risks and benefits of the donation, and of the alter- minimum age criteria to become a living kidney donor.53
native treatment options available to the recipient (disclo- For example, prior guidelines indicate that persons who are
sure), understands this information (understanding), and younger than 18 years or who lack the mental capacity to
is acting voluntarily (voluntarism). This chapter provides provide informed consent should not become living kidney
recommendations to ensure satisfaction of the informed donors with the assistance of substitute decision-makers,
consent requirements for the living kidney donor candidate. and that donation in such a setting only be considered in
The reader should also refer to chapter 1 for related discus- highly exceptional circumstances (eg, young parent to child)
sions on the framework for decision-making and chapter 18 after ethical and legal review.18,38,47,48,51,54,55
on the ethical, legal, and policy framework of living dona-
tion. Details of specific donation-related surgical, medical, Content of Disclosure
and psychosocial risks are provided in other chapters (3-17) Transplant programs must have a process to communicate
of the guideline. relevant information to donor candidates that enables informed
decision making.18 Some prior guidelines have suggested use of
Process of Informed Consent a standardized checklist to ensure that all items are disclosed.50
Transplant programs must establish a defensible process For US programs, the Organ Procurement and Transplantation
to ensure that the requirements of informed consent are Network (OPTN) has developed an informed consent checklist
met.18,38-41 To date, donor candidate informed consent pro- for programs to support compliance with policy requirements56
cesses have been shown to vary widely across transplant pro- and a patient resource (English and Spanish translations) to ex-
grams worldwide, with discrepancies noted in standards, plain the process in lay language for donor candidates.57
consistency and implementation.39,40,42-45 It has been recom- The donor candidate needs to be informed from the onset
mended that the informed consent structure and process be of what is involved in the donor evaluation, including the re-
the same for donor candidates regardless of relationship (or quired assessments and anticipated timelines. In general, edu-
lack thereof for nondirected donation ) between the donor cation about the process and potential outcomes of living
candidate and their intended recipient.39,46,47 donation should be introduced in a manner conducive to
Transplant programs must assure a donor candidate is act- learning and understanding. Prior guidelines and policy
ing voluntarily and not yielding to pressure or coercion. It is statements have recommended that discussions be provided
best if evaluations of the donor candidate and the intended in a language that enables meaningful dialogue between the
recipient are performed by separate teams to mitigate poten- donor candidate and transplant program staff, using com-
tial conflict of interest. A recommendation that the donor munication strategies and materials that are culturally sensi-
candidate be evaluated by a team that is independent of the tive.47,49 The information should also be presented in a
evaluation of the intended recipient is also recommended in sympathetic environment, using simple language, allowing
several past guidelines.47-51 The process of informed consent time for questions, with information that is appropriate to
with a living kidney donor candidate should include discus- a candidate’s understanding and experience, at a pace deter-
sions with a healthcare professional skilled and knowledgeable mined by their needs.49 Repetition of key information, and
in organ donation and in evaluating a person’s comprehen- use of approaches that foster adult learning, are prudent.58
sion of the information. In the United States, to minimize The information to be disclosed to the donor candidate
conflict of interest, living donor recovery hospitals must des- is described in many prior guidelines and policy state-
ignate and provide each donor candidate with an Indepen- ments.47,48,51,54,59 Some regulations require minimum con-
dent Living Donor Advocate who is independent of the tent elements that must be disclosed in the informed consent
intended recipient’s evaluation and the decision to trans- process,51 and these requirements should be respected when
plant the intended recipient. This person seeks to ensure locally applicable. The donor candidate must also provide
that the rights of the donor candidate are protected, that all consent for some tests performed during the evaluation, such
the requirements of informed consent are met, and that the as consent to receive intravenous contrast for renal imaging. In
donation decision is made voluntarily.51 Other countries this guideline, we present a list of the content of recommended
may use other strategies such as an external review of disclosures during the donor candidate evaluation, consider-
planned donations to ensure that independence, advocacy ing these prior guidelines and policies (Table 11). Candidates
for the donor’s rights, and voluntarism are respected.52 should also be reminded that they can only donate a kidney
While avoidance of conflict of interest is a central principle, as a living person once, even though they may know some-
it also remains important that healthcare professionals in one else who may need a kidney transplant in the future.
the teams evaluating the donor candidate and intended recip- Treatment alternatives available to transplant candidates
ient work together to ensure effective communication and co- (in general terms, not with specific recipient medical informa-
ordination of the donation and transplant processes. For tion) should be disclosed to the donor candidate (Table 11).
example, it would be inefficient to fully evaluate a donor can- Donor candidates who are biologically incompatible with
didate if their intended recipient does not meet eligibility an intended recipient should be informed of the availability
criteria for transplantation. desensitization protocols and kidney paired donation (KPD),
and the considerations related to pursuit of these treatment op-
Capacity for Decision Making tions. Logistics, outcomes and risks specific to KPD and
The transplant team has a duty to confirm that the donor planned incompatible transplantation are discussed in chap-
candidate has the capacity to provide informed consent, ter 3 of this guideline. Participation in KPD and incompatible
C.Agnello SE 0247
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 251 of 569 PageID S29
KDIGO Living Kidney Donor Work Group
#:
445
TABLE 11.
Recommended content of disclosure during the evaluation of living donor candidates
Type of disclosure Information disclosed to the donor candidate
Handling of donor candidate’s personal • Personal health information collected during the donor candidate evaluation is confidential and
health information protected under privacy law, similar to other personal health information
• The transplant program will only disclose a donor candidate’s personal health information to the
intended recipient or other parties with the donor candidate’s permission
• The donor candidate may be asked for permission to disclose certain personal health information to
their intended recipient. This information may include the donor candidate’s identity, immunonlogical
compatibility, and medical history affecting the risk of disease transmission
Risks of discovery of donor health information • The program’s policy for disclosing information and arranging follow-up care for each of the following:
◯ A health condition that may require further medical intervention
◯ A health condition that could affect the donor candidate’s ability to obtain insurance (eg, life, medical,
disability), or the cost of insurance
◯ An infectious disease that must be reported to public health authorities
◯ A misattributed biological relationship between the donor candidate and intended recipient (such as
misattributed paternity in a father-child relationship) discovered through blood group and immune
compatibility testing
Risk and expected outcomes of donation • The anticipated medical, surgical, psychosocial, and economic risks and outcomes of donation (for specific
details see other chapters of this guideline), and the uncertainty in estimating risk and outcomes
Treatment alternatives available to transplant • Treatment options for kidney failure, including dialysis and deceased donor kidney transplantation, and their
candidates average expected outcomes compared with living kidney donor transplantation
Process of transplant candidate selection and when • Transplant candidate evaluation teams determine eligibility to receive a kidney transplant based on
the intended recipient’s personal health information program criteria and clinical judgment
is shared with the donor candidate • Personal health information collected during the transplant candidate’s evaluation is confidential, protected
under privacy law, and is not generally shared with the donor candidate unless: 1) the transplant program
determines the donor candidate requires such information to make an informed decision about proceeding
with donation, and 2) the intended recipient gives permission for this information to be shared with
the donor candidate
Processes of donor candidate evaluation, candidacy • Separate consents may be needed for some tests
determination, and follow-up • Programs and personnel available to help donors with the financial burden of donation
• It may be a crime to receive any valuable consideration (money, property) for donation
• A description of what will happen if the candidate decides not to donate, emphasizing the right of the
candidate to decline to donate at any time with the full support of the transplant program
• The transplant program decides if the donor candidate is eligible for donation based on the results of
their evaluation
• If excluded from donation, information on why the donor candidate does not meet the program’s criteria
for donation and how the transplant program will support the candidate
• The program’s recommendations for follow-up care, including the timing and financial impacts of care and
the need for regular, ongoing healthcare maintenance and healthy lifestyle choices
• The program’s need to collect ongoing personal health information after donation to inform the care of the
recipient, and to guide the care of the donor
• The program’s policy about providing care to the donor after evaluation and donation
• The availability of national and regional policies to assure prompt access to dialysis and transplantation
for living donors who develop kidney failure
transplantation requires specific informed consent, and min- that requires referral for further care, discovery of a health
imum content elements may be specified by paired donation condition that could affect the donor candidate’s insurability
programs.60,61 The transplant program should inform the or cost of insurance, or discovery of an infectious disease for
donor candidate of policies regarding confidentiality and an- which there is a reporting requirement to public health au-
onymity in KPD and nondirected donation, and should en- thorities. Transplant programs should establish policies for
sure donor acceptance of these policies before donation.62 managing such discoveries, and share these policies with
Some programs now permit biologically compatible pairs the donor candidate as part of the informed consent process
to participate in KPD; when this option is discussed, donor for evaluation. Testing a donor candidate and intended re-
candidates who are biologically compatible with their in- cipient in a family for the purpose of assessing immune com-
tended recipient should voluntarily decide whether or not patibility may identify misattributed biological relationships
to pursue this option.63-65 as an incidental finding. For example, misattributed paternity
Participating in donor evaluation includes risks of discov- is estimated to occur in approximately 1 to 3% of father-
ery. These risks include possible discovery of a health condition child living kidney donor-recipient pairs, or approximately
C.Agnello SE 0248
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 252 of 569 PageID #:
S30 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 446 www.transplantjournal.com
0.25% to 0.5% of all living kidney donation evaluations.66 with the recipient after donation, such as in the rare circum-
Transplant programs should establish a policy on how or stance where soon after transplant (ie, within 1-2 years) it is
whether this information is disclosed.67,68 discovered the donor has evidence of a serious infectious dis-
The donor candidate should be informed of donation- ease or malignancy.51
related surgical, medical, and psychosocial outcomes and It is possible that the intended recipient has health infor-
risks as provided in other chapters of this guideline, individu- mation that could impact transplant outcomes, and which
alized whenever possible for donor characteristics, and includ- the transplant team believes could affect the donor candi-
ing the uncertainty of estimates. As described in chapter 1, date’s decision making. For example, some donor candidates
90-day all-cause mortality after donation in a US study of may want to know if the recipient lost a previously transplanted
80 347 donors (1994-2009) based on registry data and na- kidney due to medication nonadherence.72 Knowledge of a
tional death records was approximately 1 in 3000 (0.03%).23 Sim- genetic kidney disease in an intended recipient may be impor-
ilar rates have also been reported in other studies.24,25 Given tant for the evaluation and care of a genetically related donor
the low incidence of perinephrectomy mortality, estimates for candidate. As for the health information of donor candi-
predonation characteristics that alter the risk of perioperative dates, personal health information collected during the trans-
death are imprecise. plant candidate’s evaluation is protected under privacy law,
The donor candidate should be informed of anticipated re- and can only be shared with permission of the intended re-
cipient outcomes associated with living donor transplanta- cipient. Prior guidelines, such as those of the British Trans-
tion (such as 1-year, 5-year and median recipient graft and plantation Society and policy of the US OPTN, recommend
patient survival), and with available treatment alternatives disclosure of relevant information about the intended recipient
including deceased kidney donor transplantation and differ- to the donor candidate if the intended recipient has given
ent types of dialysis. US policy requires that donor candidates consent48,51; the British Transplantation Society also recom-
are provided with current national and program-specific mends that donation and transplant not proceed unless the
1-year transplant recipient patient and allograft survival sta- relevant information is shared.48 The criteria for relevant in-
tistics, and that donor candidates are also informed that any formation beyond the determination that the intended recipi-
transplant candidate may have risk factors for increased like- ent is approved as a suitable transplant candidate by their
lihood of adverse outcomes (including graft failure, complica- evaluation team are currently undefined. Ongoing efforts are
tions, mortality) that exceed local or national averages.51 warranted to develop standardized criteria for the identification
Many regions have legislation that protects the confidenti- and disclosure of recipient risk factors for adverse transplant
ality of personal health information, and the same protec- outcomes that may be relevant to donor decision making,
tions apply to information collected during the donor and when donation and transplant should not proceed in
candidate evaluation. The donor candidate should know that the absence of disclosure, weighing considerations of privacy
their personal health information will only be disclosed to law, ethics, and the concerns of donor and recipient candi-
their intended recipient or other parties if they provide per- dates (see Research Recommendations).
mission to do so. The donor candidate should also know that Donor candidates should be informed of transplant pro-
it is likely they will be asked for permission to disclose certain gram resources and personnel available to offer support.
personal health information to their intended recipient so Such support can include psychological support in the setting
that the intended recipient can provide informed consent of a poor recipient outcome after transplantation or donor
for the transplant to occur.69,70 For example, in directed do- complications, or financial reimbursement programs for
nation, while a donor candidate may wish to keep their act of out-of-pocket expenses incurred during the evaluation and
donor evaluation initially confidential, if the transplant pro- donation process. The donor candidate should understand
gram does not permit anonymous directed donation, or if what is required of them after donation, including the likely
the intended recipient does not wish to proceed with anony- timing and financial impacts of donation-related recom-
mous directed donation, there may be a need for the donor mended lifelong healthcare. The donor candidate should also
candidate to provide permission for their identity to be understand how this care will be provided after donation,
disclosed to the intended recipient so that the intended recip- and the transplant program’s policy for providing any health-
ient can make an informed decision about proceeding with care (and what types of healthcare) after donation. In the US
the transplant. Similarly, donor candidates and intended re- transplant programs are required to collect and report
cipients need to provide permission to make each other follow-up data on donors for 2 years after donation.73
aware whether they are biologically compatible or not. Dur- In nearly all places in the world it is a crime to knowingly
ing the donor evaluation process, it may be recognized that a acquire or obtain any human organ for valuable consider-
donor candidate has additional health information that ation (ie, for anything of value such as money or property).
could impact the transplant outcome. For example, despite Some prior guidelines recommend the donor candidate sign
negative serological testing, a donor candidate may have a a statement attesting that they are not donating a kidney
higher risk of specific infectious diseases based on his/her be- for monetary gain46,74; in the United States, such attestation
havioral history. Some jurisdictions require standardized be- is required for donation to proceed.51 The donor candidate
havioral screening71 during the evaluation and consent should understand the withdrawal process from evaluation,
from the donor candidate to inform the intended recipient and their right to withdraw at any time before donation with
of behavior associated with increased risk of certain infec- the full support of the transplant program (described further
tions, so that the intended recipient can provide informed below in this guideline chapter). Finally, while transplant
consent for the transplant to proceed.51 Before donation the programs respect the autonomy of a donor candidate to pro-
transplant program should also inform the donor candidate ceed with donation based on their preferences, needs and
of requirements to share certain personal health information values, programs remain ethically justified to decline a donor
C.Agnello SE 0249
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 253 of 569 PageID S31
KDIGO Living Kidney Donor Work Group
#:
447
candidate who does not meet their eligibility criteria for do- their participation in evaluation and personal health informa-
nation (ie, when the donation is deemed to incur unaccept- tion is confidential, to be shared with the intended recipient
able risks).22 A donor candidate should understand the only with their approval. This enables the donor candidate
transplant program makes the final determination of whether to speak openly about their health and donation choices.
the donor candidate is eligible for donation or not based on For the purposes of donor candidacy, ‘not deciding’ about
the results of their evaluation. If the donor candidate does donation should be considered the same as ‘deciding not to’
not meet the transplant program’s criteria for donation, the proceed, as may occur in cases of ambivalent donor candidates
program should inform the donor candidate of the decision who have not decided to proceed, but who also have not
and reason. Being told they do not meet a transplant pro- elected to formally withdraw from the donation process.39
gram’s acceptance criteria is distressing for some donor can- Transplant programs should support donor candidates
didates.75 The donor candidate should be informed how the who decide to withdraw from the evaluation process or de-
transplant program will support them if they do not meet cline to donate in a way that is respectful and confidential.81
criteria for donation. Such support may include assistance So-called ‘medical alibis,’ provision of a false medical reason
in communicating the decision to the intended recipient; on- to justify unsuitability as a living donor, are discouraged as
going follow-up communication with the evaluation team; untruthful statements may undermine trust in the transplant
counseling related to the outcome of the evaluation; alterna- program and the patient/physician relationship.81 Thiessen
tive ways of helping the intended recipient; and the possibility et al recommend that all donor candidates be offered a gen-
of referral to another program for a second opinion if the do- eral statement regarding ‘unsuitability to donate’ at any time;
nor candidate does not accept the noneligibility decision. there is controversy about whether the transplant program
should assist the donor candidate with wording that includes
Comprehension of Disclosed Information factual medical findings which may or may not preclude do-
Donor candidates should have adequate time to consider the nation (such as mildly elevated BP or risk factors for meta-
information they are provided during the evaluation process, as bolic syndrome).82 Understandably, a donor candidate who
this is required for informed consent. The duration of adequate decides not to donate may have difficulty communicating this
time is not well defined, and may vary according to donor char- decision to the intended recipient or others; in such circum-
acteristics. Some, but not all transplant programs, require all do- stances the transplant program should assist with this com-
nor candidates to exercise a minimal period for this adequate munication, which may involve communication through
consideration, referred to as a ‘cooling-off’ period.44 the recipient evaluation team to the transplant candidate.
In current routine care, an assessment of a donor candi-
date’s knowledge and comprehension of the possible out-
comes of donation is typically done through discussions RESEARCH RECOMMENDATIONS
with healthcare professionals. Optimal methods to assess
understanding in living donor candidates are not well de- • Determine the best methods to achieve informed consent
fined,39,58 but general techniques for comprehension assess- from living kidney donor candidates, including what
ment may include use of “teach-back,” in which patients are methods are most useful to impart information including
asked to "teach back" what they have learned during their risks and outcomes and what methods are most useful to
assess comprehension.42
visit.76 An instrument for assessing comprehension during
• Through focus groups and/or surveys, develop standardized
informed consent for living liver donation has been pilot criteria for circumstances under which intended recipients
tested,77 and provides a model for developing similar instru- should be asked for permission to disclose certain personal
ments for comprehension assessment in living kidney donor health information to the living kidney donor candidate
candidates. It is common for many donor candidates to voice (such as loss of a prior graft due to medication nonadher-
no concerns during the evaluation process about the dona- ence), so that donor candidates can make an informed de-
tion, as they are using an emotional rather than deliberative cision about whether to proceed with donation or not.
decision-making process. Some donors have an exaggerated ◯ Develop standardized criteria for when donation and
sense of the true benefit of donation to their intended recipi- transplant should not proceed in the absence of disclo-
ent, while others underappreciate the amount of postopera- sure, weighing considerations of privacy law, ethics,
and the concerns of donor and recipient candidates.
tive physical pain they may experience or the time needed
• Perform postdonation surveys to measure donors’ assess-
to fully recover after surgery.78 ments of the quality of standardized informed consent
processes, including if the information provided before
The Voluntary Nature of Kidney Donation donation met the donor’s needs and prepared them for
Voluntarism is established when a transplant program en- the donation.83
sures the donor candidate is free from undue pressure or co- • Compare experiences of donors who donated before
ercion in deciding whether or not to donate.79 Voluntarism and after the implementation of country-specific regula-
should be respected by all members of the transplant team; tions for better informed consent processes for the prac-
as discussed above, additional safeguards may include use tice of living donation.
of Independent Living Donor Advocates or external reviews • Evaluate appropriate circumstances for and approaches to
substitute decision making and use of surrogate consent,
of planned donations.51,52 Special groups such as prisoners
including definition of the necessary supporting ethical
have unique considerations.80 Interviewing the donor can- framework for particular scenarios.
didate without the intended recipient, family members and • Develop ethically-grounded, practical strategies to consider
other persons who could influence the donation decision is im- and manage evaluation of living kidney donor candidates
portant in the assessment of voluntarism. Trust is maintained identified by the intended recipient or their representatives
when the transplant program assures a donor candidate that through mass advertising and social media.84
C.Agnello SE 0250
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 254 of 569 PageID #:
S32 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 448 www.transplantjournal.com
CHAPTER 3: COMPATIBILITY TESTING, Counseling Regarding Transplant Options
INCOMPATIBLE TRANSPLANTATION, and Expected Outcomes
AND PAIRED DONATION Biological incompatibility remains a significant barrier
The ERT search parameters did not identify evidence from to living donor kidney transplantation. Estimates based on
eligible studies pertinent to the recommendations in chapter 3 blood group prevalence in the United States suggest that more
and therefore the following recommendations are “Not than 35% of willing, healthy potential living donors are blood
Graded.” group incompatible with their intended recipients.90 Options
for transplant candidates whose only willing, healthy donor
Evaluation is ABO or HLA incompatible include: KPD, planned incom-
3.1: Donor ABO blood typing should be performed twice be- patible transplantation (with preconditioning/desensitization
fore donation to reduce the risk of unintended blood type treatment of the intended recipient as needed), attempting to
incompatible transplantation. find a different living donor, or waiting for a compatible de-
3.2: Donor blood group A subtype testing should be per- ceased donor organ.91-93 While evaluation and management
formed when donation is planned to recipients with of the transplant recipient is not within the scope of this pro-
anti-A antibodies. ject, outcomes of recipients after various forms of transplant
3.3: Human leukocyte antigen (HLA) typing for major histo- or waiting are relevant to living kidney donor candidate edu-
compatibility complex (MHC) Class I (A, B, C) and Class cation. Perspectives of risk and benefit for counseling of the
II (DP, DQ, DR) should be performed in donor candidates intended recipient and donor candidate include outcomes
and their intended recipients, and donor-specific anti-HLA
after compatible versus incompatible transplantation, out-
antibodies should be assessed in intended recipients.
comes after incompatible transplantation versus dialysis, and
Counseling the likelihood of transplantation with options including KPD
programs. Donor candidates who are ABO or HLA incom-
3.4: Donor candidates who are ABO blood group or HLA in- patible with their intended recipient should be informed of
compatible with their intended recipient should be in- expected patient and graft survival for KPD and incompati-
formed of availability, risks, and benefits of treatment ble transplantation, as compared with compatible living do-
options, including kidney paired donation and incompat- nor transplantation and deceased donor transplantation, as
ibility management strategies.
well as expected patient survival on dialysis, based on best
3.5: If a donor candidate and their intended recipient are
blood type or crossmatch incompatible, transplantation available information.
should be performed only with an effective incompatibil-
ity management strategy.
Kidney Paired Donation
3.6: Nondirected donor candidates should be informed of
availability, risks and benefits of participating in kidney KPD has emerged as a successful approach to address
paired donation. ABO blood group and HLA incompatibilities for those who
have a willing, but incompatible living donor candidate.
RATIONALE The fastest growing modality for living donor transplanta-
tion is KPD, rising from 2 cases in 2000 to approximately
Evaluation: Blood Type and Histocompatibility Testing 700 cases reported to the US OPTN in 2013.94 In 2004, the
ABO blood typing should be performed in living donor Netherlands instituted a paired exchange system in all their
candidates before donation, including routine duplicate test- transplant centers, which may explain the recent increase in
ing, to reduce the risk of unintended blood type-incompatible living kidney donation in that country.95
transplantation. Unintended ABO-incompatible (ABOi) Donor candidates who are ABO or HLA incompatible with
transplantation should be avoidable with ABO typing of their intended recipient should be informed of the availability of
the donor and the recipient; however, human errors have KPD, and the considerations related to pursuit of this treatment
led to cases of accidental ABOi organ transplantation in con- option. Participation in KPD requires KPD program-specific
temporary practice.85 ABO-subtype testing should be per- informed consent60,61 (Please see also chapter 2: Informed
formed when donation is planned to recipients with anti-A Consent for details). The transplant program should inform
antibodies.86 Human leukocyte antigen (HLA) typing for the donor candidate of policies regarding confidentiality
major histocompatibility complex (MHC) class I (A, B, and anonymity in KPD and nondirected donation, and
C) and class II (DP, DQ, DR) should be obtained in living do- should ensure donor acceptance of these policies before
nor candidates for recipient candidates with anti-HLA anti- donation.62 Some programs now permit biologically compat-
bodies, as part of the assessment of compatibility during ible pairs to participate in KPD; when this option is discussed,
preoperative planning; there is an association between the donor candidates who are biologically compatible with their
presence of HLA-C and/or HLA-DP and DQ and a higher in- intended recipient should voluntarily decide whether or not
cidence of graft rejection.87,88 While recipient care is out of to pursue this option.63-65
the scope of this guideline, it is important to emphasize that Donor candidates participating in KPD should be in-
recipient candidates should undergo antidonor antibody ex- formed of the risks and benefits of kidney transport, possible
aminations, including complement-dependent cytotoxicity organ redirection due to unforeseen circumstances, the in-
or flow cytometry crossmatching and Luminex (Bio-Rad ability to provide information on the ultimate recipient of
Laboratories, Inc., Hercules, CA) assays to determine the his- their organ, as well as nonexchange donation options.60 Liv-
tory of sensitization,89 and this testing should be current be- ing donors participating in exchanges should have the option
fore proceeding with donor nephrectomy and living donor to travel to the recipient center; however, experience from
transplantation. countries with well-developed KPD programs suggests that
C.Agnello SE 0251
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 255 of 569 PageID S33
KDIGO Living Kidney Donor Work Group
#:
449
transport of living donor kidneys can be accomplished safely management including B-cell-depleting treatments (eg, anti-CD
without adversely impacting transplant outcomes, obviating 20 antibody, rituximab) and/or splenectomy and/or intravenous
the need for donor travel. In a survey of 30 US programs immunoglobulin, but increased risk of early rejection remains,
transporting 56 living donor kidneys (2007-2010), the creat- requiring additional immunosuppression and attendant risks
inine nadir was less than 2.0 mg/dL (<177 μmol/L) in all re- to the recipient. Nonetheless, while allograft survival after
cipients but one, and there were no cases of delayed graft HLA-incompatible living donor kidney transplantation is inferior
function as defined by the need for dialysis in the first week.96 to compatible transplantation, incompatible transplantation after
Continued feasible and safe transport of living donor kidneys desensitization may offer a substantial survival benefit compared
in the United States has been reported.97 with dialysis or waiting for a deceased donor kidney; however,
Nondirected donors (donor without an identified recipi- there are few high-quality studies testing this hypothesis. A recent
ent) have the unique potential to expand the donor pool study compared 1025 recipients of HLA-incompatible living do-
through chains of kidney exchanges.98 Nondirected donor nor kidney transplants at 22 US medical centers with matched
candidates should be informed of opportunities for donating controls who remained on waiting lists or waited and re-
into a chain or KPD program, if available. ceived a transplant from a compatible deceased donor. After
Participation in KPD should be considered preferable to 8 years, 76.5% of those who received an incompatible living
incompatible transplantation if participation is deemed to donor transplant were still alive, compared with 62.9% who
have “reasonable” likelihood of yielding a compatible or remained on the waiting list or received a deceased donor
lower-immunologic risk match for the donor candidate’s transplant and only 43.9% who remained on the waiting list
intended recipient. Despite the expansion of KPD, blood but were never transplanted.109 HLA-incompatible transplan-
group O candidates continue to have much lower rates of tation does confer additional costs compared with compatible
success on KPD lists than their non–O counterparts, particu- transplantation, but may be cost-effective compared with dial-
larly in circumstances of broad HLA sensitization.86 Thus, ysis; formal cost effectiveness evaluations are needed.110
for some transplant candidates, incompatible transplantation
What Prior Guidelines Recommend
may offer their best option for transplantation without pro-
longed waiting times. In contrast with our recommendations, the European
Renal Best Practice (ERBP) guideline for kidney donor and
Blood Type-Incompatible Living Donor Transplantation recipient evaluation recommends performing HLA-DQ,
While incompatible transplantation without preconditioning/ HLA-DP and HLA-C typing of the donor only when the
desensitization treatment of the recipient may lead to hyper- intended recipient has HLA antibodies against those anti-
acute rejection and allograft loss, predetermined incompati- gens.50 The ERBP does not recommend routine typing for
bility management protocols have been developed in recent MHC Class I-related chain-A and other non-HLA antigens
decades. In 1987, successful ABOi living donor transplantation in either recipient or donor. Similar to our recommendations,
was introduced in Japan using pretransplant antibody depletion, the ERBP recommends establishing programs to select a
to expand access to transplantation in the absence of legal recog- donor towards whom the recipient does not produce anti-
nition of brain death.99-101 Since that time, ABOi transplantation bodies through KPD, and recommends transplanting pa-
evolved into routine practice and constituted nearly 14% of living tients with donor-specific antibodies only if this cannot
donor transplant procedures performed in Japan in 2011. be accomplished by KPD.50 Details of testing and clinical
Recipient and donor candidates interested in ABOi living management associated with HLA and non-HLA antibod-
donor transplantation should be informed of possible com- ies in transplantation are out of the scope of the current
plications and expected outcomes. US studies have reported guideline, but consensus-based recommendations from a
higher rates of perioperative complications including hemor- 2012 Transplantation Society work group are available.89
rhage, infections, and early graft loss compared with ABO- In 2012, the American Society of Transplantation (AST)/
compatible (ABOc) transplantation.91,102 In contrast, some American Society of Transplant Surgeons (ASTS) held a con-
European and Asian studies have found no increases in early sensus conference directed at overcoming barriers to the
or longer-term complications after ABOi transplantation,103-106 adoption of KPD that produced recommendations related
possibly reflecting differences in preconditioning manage- to KPD donor evaluation and care, guidelines for KPD histo-
ment protocols. Even in the US experience, after an early re- compatibility testing, and recommended policies to overcom-
duction in graft survival relative to blood ABOc living donor ing geographic barriers to KPD.60
kidney transplant recipients,91 the average long-term graft
survival in ABOi living donor transplant recipients is not in- RESEARCH RECOMMENDATIONS
ferior to, and often exceeds, that of ABOc deceased donor
transplant recipients.91,107 In the United States, recipients of • Define mediators of clinical outcomes and optimal manage-
ABOi living donor kidney transplants also appear to incur ment of ABO and HLA incompatible living donor transplan-
tation to support donor and recipient selection, understanding
higher costs of care before, during, and after transplant, al- of transplant utility and informed consent, including:
though these costs increases are offset by avoiding long-
◯ Standardized, controlled comparisons of preconditioning/
term dialysis and its associated morbidity and costs.108 desensitization and posttransplant immunosuppressive pro-
tocols for incompatible transplantation
HLA-Incompatible Living Donor Transplantation ◯ Elucidation of the mechanisms of antibody production and
HLA-incompatible transplantation remains the most diffi- long-term impact on the allograft
cult hurdle in achieving successful transplant outcomes. Flow • Develop a long-term, appropriately powered RCT to compare
cytometry crossmatching + or Luminex +/complement de- the outcomes and cost effectiveness of options for highly sen-
pendent cytotoxicity- incompatibility may be acceptable with sitized candidates including participation in KPD with varying
C.Agnello SE 0252
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 256 of 569 PageID #:
S34 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S450 www.transplantjournal.com
waiting times versus living donor transplantation after various to the national registry, and use of weighting schemes to draw
desensitization protocols. inferences for a “represented” sample of all US donors based
on a stratified sample of 20% of acute care hospitalizations.
CHAPTER 4: PREOPERATIVE EVALUATION A subsequent study integrated national US donor registry
AND MANAGEMENT data as a source of verified living donor status with adminis-
The ERT search parameters did not identify evidence from trative records from a consortium of 98 academic hospitals
eligible studies pertinent to the recommendations in chapter 4 (2008 to 2012, n = 14 964), and found that 16.8% of donors
and therefore the following recommendations are “Not experienced any perioperative complication, most commonly
Graded.” gastrointestinal (4.4%), bleeding (3.0%), respiratory (2.5%),
and surgical/anesthesia-related injuries (2.4%).29 Major
4.1: Donor candidates should receive guideline-based evalua- complications, defined as Clavien grading system for surgical
tion and management used for other noncardiac surgeries complications level 4 or 5,111 affected 2.5% of donors. The
to minimize risks of perioperative complications, includ- limitations of administrative database studies, including pos-
ing a detailed history and examination to assess risks sible coding biases, highlight the need for prospective collec-
for cardiac, pulmonary, bleeding, anesthesia-related and tion of granular clinical data on living donor perioperative
other perioperative complications. outcomes. A Norwegian registry-based study of 1022 living
4.2: Donor candidates who smoke should be advised to quit kidney donations performed between 1997 and 2008 re-
at least 4 weeks before donation to reduce their risk of
perioperative complications, and commit to lifelong ab-
corded 30 (2.9%) major complications and 184 (18%) mi-
stinence to prevent long-term complications. nor complications by Clavien grading.112
Readmission after surgery is commonly used as a measure
RATIONALE of care quality and healthcare utilization. A recent study ex-
amined postnephrectomy readmission using integrated US
Evaluation living donor registry data, records from a nationwide phar-
The goals of the general preoperative evaluation are to macy claims warehouse, and administrative records from
assess a donor candidate’s risk of perioperative complica- an academic hospital consortium (N = 14 959 donors,
tions according to their profile of predonation characteristics 2008-2012).113 Overall, 2.9% of donors were readmitted
assessed through a careful medical history, physical examina- to hospital within 90 days of donation. 11.3% donors filled
tion and testing; to determine if this risk is acceptable to pro- 1 or greater opioid prescription in the year before donation,
ceed with donation; and to counsel the donor candidate on and those with the highest level predonation opioid use were
how to minimize their risk of perioperative complications more than twice as likely as nonusers to be readmitted within
(eg, stop smoking, lose weight if obese). The donor then re- 90 days postdonation (6.8% vs 2.6%; adjusted odds ratio
ceives care during the perioperative period to minimize their [OR]; 95% lower CI [OR] 95% upper CI 1.742.493.58). Adjusted re-
risk of complications, so that they can return to their level of admission risk was also significantly (P < 0.05) higher for
presurgical function as quickly as possible. Recommendations women (adjusted OR = 1.25), African Americans (adjusted
on how to achieve these outcomes with good preoperative OR = 1.45), spouses (adjusted OR = 1.42), exchange partic-
evaluation and management are sparse in prior living kidney ipants (adjusted OR = 1.46), uninsured donors (adjusted
donor guidelines, other than a description of elements of the OR = 1.40), donors with predonation eGFR <60 mL/min
detailed history required before donation (eg, prior surgeries, per 1.73 m2 (adjusted OR = 2.68), donors with
anesthesia-related reactions and bleeding disorders).51 Asso- predonation pulmonary disease (adjusted OR = 1.54), and
ciations of donation-specific surgical techniques with periop- after robotic nephrectomy (adjusted OR = 1.68). Continued
erative outcomes are described elsewhere (see chapter 17). efforts to identify and prevent modifiable causes of postopera-
tive complications in all donors are warranted to maximize
Risks of Perinephrectomy Complications safety of the donation procedure.
Living kidney donor nephrectomy is an elective surgical Readers are encouraged to refer to chapter 17 for discus-
procedure that carries a low risk for complications as com- sion of acceptable surgical approaches to donor nephrec-
pared with other types of surgical procedures. As described tomy and anticipated outcomes. As discussed in the
in chapter 1, the 90-day all-cause mortality in a US study of Framework for this guideline (chapter 1), the transplant pro-
integrated donor registry data and national death records gram team should provide the donor candidate with individu-
(80 347 donors, 1994-2009) was approximately 1 in 3000 alized quantitative estimates of short-term and long-term risks
(0.03%) based on 25 deaths.23 Similar rates have also been from kidney donation to the extent possible, including recog-
reported in other studies.24,25 Given the low incidence of peri- nition of associated uncertainty, in a manner that is easily un-
operative mortality, estimates for predonation characteristics derstood by donor candidates.
that alter the risk of perioperative death are imprecise.
A US study recently described the incidence of periopera- Preoperative and Perioperative Management to
tive complications in a large sample of living kidney donors Minimize the Risk of Perinephrectomy Complications
from 1998 to 2010.28 Outcomes were assessed through ad- Guidelines for evaluation and management before noncar-
ministrative data, using a composite outcome of digestive, re- diac surgery in the general population have been thoroughly
spiratory, procedural, urinary, hemorrhage, infectious or reviewed and summarized.114 There is no evidence to sug-
cardiac complications. The incidence of perioperative com- gest that additional preoperative testing beyond guideline-
plications was 7.9% and decreased from 1998 to 2010 (from based evaluation and management strategies used for other
10.1% to 7.6%). Limitations of this study include the lack of noncardiac surgeries results in a reduced incidence of periop-
confirmation of donor status through patient level-linkages erative complications in kidney donors.
C.Agnello SE 0253
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 257 of 569 PageID S35
KDIGO Living Kidney Donor Work Group
#:
451
Some transplant programs routinely perform preoperative spirometry, or selective use of a nasogastric tube (as needed
noninvasive cardiac testing in older living kidney donor can- for postoperative nausea or vomiting, inability to tolerate
didates (eg, stress electrocardiogram, nuclear stress test), but oral intake, or symptomatic abdominal distention). The
this practice is not supported by existing evidence. Recent US utility and difficulties of the preoperative evaluation for
guidelines for the general population do not recommend car- the potential identification of obstructive sleep apnea is de-
diac testing for those undergoing noncardiac surgery with no scribed elsewhere.122
active symptoms of heart disease who have reasonable func- There have been 6 RCTs that enrolled smokers (ranging
tional capacity (defined as at least 4 metabolic energy equiv- from 47 to 213 patients) to receive a smoking cessation inter-
alents, which represents the ability to walk 2 blocks on vention or not before surgery (procedures other than donor
ground level or carry 2 bags of groceries up one flight of stairs nephrectomy)123 and found that smoking cessation reduced
without symptoms).115 Outside the context of perioperative the risk of perioperative complications.
evaluation, other guidelines recommended against noninva-
sive cardiac testing for asymptomatic coronary artery dis-
ease, or conclude that there is insufficient evidence to RESEARCH RECOMMENDATIONS
warrant such testing.116 • Develop contemporary estimates of 5.10, the risk of peri-
Recent guidelines on the assessment of bleeding risk before nephrectomy complications according to an individual-
surgery or invasive procedures describe the following117: ized profile of predonation characteristics, accounting
(i) Routine coagulation screening before surgery to predict for changes in baseline comorbidity burdens.
postoperative bleeding in unselected patients is not recom- • Assess the predictive value of novel risk factors for perioper-
mended; (ii) bleeding history assessment should include de- ative complications and readmission after donor nephrec-
tails of a family history of bleeding, previous excessive tomy, including use of opioids and other pharmaceuticals.113
posttraumatic or postsurgical bleeding, and current use of an- • Perform RCTs to formally assess the efficacy of evaluation
and perioperative management techniques to minimize
tithrombotic drugs; (iii) if the bleeding history is negative, no the risk of perioperative complications after living donor
further coagulation testing is indicated; (iv) comprehensive nephrectomy.
coagulation testing is warranted if the bleeding history is pos-
itive. Although evidence in the context of donor nephrectomy
is lacking, current OPTN policy for living donor evaluation CHAPTER 5: PREDONATION KIDNEY FUNCTION
in the United States requires assessment of bleeding and clotting Except in the case of Recommendation 5.10, the ERT search
disorders in the medical history, and performance of coagula- parameters did not identify evidence from eligible studies perti-
tion testing,51 and other prior living donor evaluation guide- nent to the recommendations in chapter 5 and therefore the
lines have recommended blood coagulation testing.54,118 following recommendations are “Not Graded.” Some of the
In a recent multicenter randomized trial of 10 010 patients recommendations extrapolated from the 2012 KDIGO CKD
undergoing noncardiac surgery, the use of aspirin before sur- Guideline (Section 1.4.3)124 were not part of the ERT review
gery and throughout the early postsurgical period had no sig- for this guideline and as such they are also “Not Graded.”
nificant effect on the risk of death or nonfatal myocardial
infarction but increased the risk of major bleeding.119 The Evaluation
trial authors recommend aspirin not be started before sur-
gery, and for those chronically taking aspirin to hold it at 5.1: Donor kidney function should be expressed as glomerular fil-
least 3 days before surgery. tration rate (GFR) and not as serum creatinine concentration.
Recent guidelines for the prevention of perioperative ve- 5.2: Donor GFR should be expressed in mL/min per 1.73 m2
nous thromboembolism (ie, deep vein thrombosis and pul- rather than mL/min.
monary embolism) describe the use of a risk score (Rogers 5.3: Donor glomerular filtration rate (GFR) should be esti-
mated from serum creatinine (eGFR cr) for initial assess-
or Caprini score) to determine which of early ambulation,
ment, following recommendations from the KDIGO
mechanical prophylaxis or perioperative unfractionated 2012 CKD guideline.
heparin (or low-molecular-weight heparin) is warranted to 5.4: Donor GFR should be confirmed using one or more of
reduce risk.120 Factors associated with a higher risk of peri- the following measurements, depending on availability:
operative venous thromboembolism include older age,
obesity, and the use of oral contraceptive or hormone re- • Measured GFR (mGFR) using an exogenous filtration
marker, preferably urinary or plasma clearance of in-
placement therapy. Many donors will be at low risk (<2%)
ulin, urinary or plasma clearance of iothalamate, uri-
of perioperative venous thromboembolism, and some guide- nary or plasma clearance of 51Cr-EDTA, urinary or
lines suggest early ambulation is all that is required in indi- plasma clearance of iohexol, or urinary clearance of
viduals at low risk of such events. 99m
Tc-DTPA
Guidelines to reduce the risk of perioperative pulmo- • Measured creatinine clearance (mCrCl)
nary complications recommend a careful assessment of • Estimated GFR from the combination of serum creati-
risk factors for postoperative pulmonary complications nine and cystatin C (eGFRcr-cys) following recommen-
(conditions such as chronic obstructive pulmonary disease dations from the KDIGO 2012 CKD guideline
or congestive heart failure which will be absent in almost • Repeat estimated GFR from serum creatinine (eGFRcr)
all donors).121 Preoperative spirometry and chest radiog- 5.5: If there are parenchymal, vascular or urological abnor-
raphy are not recommended as routine tests to predict the malities or asymmetry of kidney size on renal imaging,
risk for postoperative pulmonary complications. Patients single kidney GFR should be assessed using radionu-
at higher risk for postoperative pulmonary complications clides or contrast agents that are excreted by glomerular
may benefit from deep breathing exercises or incentive filtration (eg, 99mTc-DTPA).
C.Agnello SE 0254
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 258 of 569 PageID #:
S36 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 452 www.transplantjournal.com
Selection
• We recommend that clinicians (Recommendation 1.4.3.3,
5.6: GFR of 90 mL/min per 1.73 m2 or greater should be Grade 1B):
considered an acceptable level of kidney function for ◯ Use a GFR estimating equation to derive GFR from se-
donation. rum creatinine (eGFRcr) rather than relying on the se-
5.7: The decision to approve donor candidates with GFR 60 rum creatinine concentration alone.
to 89 mL/min per 1.73 m2 should be individualized ◯ Understand clinical settings in which eGFRcr is less accurate.
based on demographic and health profile in relation to • We recommend that clinical laboratories should (Recom-
the transplant program’s acceptable risk threshold. mendation 1.4.3.4, Grade 1B):
5.8: Donor candidates with GFR less than 60 mL/min per ◯ Measure serum creatinine using a specific assay with
1.73 m2 should not donate. calibration traceable to the international standard
5.9: When asymmetry in GFR, parenchymal abnormalities, reference materials and minimal bias compared to
vascular abnormalities, or urological abnormalities are isotope-dilution mass spectrometry (IDMS) reference
present but do not preclude donation, the more severely methodology.
affected kidney should be used for donation. ◯ Report eGFRcr in addition to the serum creatinine con-
centration in adults and specify the equation used
Counseling whenever reporting eGFRcr.
◯ Report eGFRcr in adults using the 2009 CKD Epidemiology
5.10: We suggest that donor candidates be informed that Collaboration (CKD-EPI) creatinine equation. An alter-
the future risk of developing kidney failure necessi- native creatinine-based GFR estimating equation is ac-
tating treatment with dialysis or transplantation is ceptable if it has been shown to improve accuracy of
slightly higher because of donation; however, average GFR estimates compared to the 2009 CKD-EPI creati-
absolute risk in the 15 years following donation re- nine equation.
mains low. (2C)
• When reporting serum creatinine:
RATIONALE ◯ We recommend that serum creatinine concentration be
reported and rounded to the nearest whole number when
Evaluation expressed as standard international units (μmol/L) and
rounded to the nearest 100th of a whole number when
The goals of the evaluation of kidney function in living donor expressed as conventional units (mg/dL).
candidates are to: • When reporting eGFRcr:
• Provide accurate assessment of level of GFR and predic- ◯ We recommend that eGFRcr should be reported and
tion of long-term risk of ESKD (in the absence of and af- rounded to the nearest whole number and relative to
ter donation) based on level of predonation GFR and a body surface area of 1.73 m2 in adults using the units
other factors. mL/min per 1.73 m2.
◯ We recommend eGFRcr levels less than 60 mL/min per
• Allow identification and exclusion of donor candidates
whose postdonation risks are expected to exceed the accept- 1.73 m2 should be reported as “decreased.”
able risk threshold established by the transplant program. • If cystatin C is measured, we suggest that health profes-
sionals (Recommendation 1.4.3.6, Grade 2C):
• Provide counseling regarding level of risk for donor can- ◯ Use a GFR estimating equation to derive GFR from se-
didates whose long-term risks for ESKD are expected to rum cystatin C rather than relying on the serum cystatin
be below the acceptable risk established by the transplant C concentration alone.
program. ◯ Understand clinical settings in which eGFRcys and
• Provide counseling regarding the need for follow-up of eGFRcr-cys are less accurate.
decreased GFR after donation. • We recommend that clinical laboratories that measure
cystatin C should (Recommendation 1.4.3.7, Grade 1B):
For this section, recommendations related to measurement
◯ Measure serum cystatin C using an assay with calibra-
of kidney function are based on physiological principles tion traceable to the international standard reference
and recommendations for general clinical practice from the material.
KDIGO 2012 CKD guideline.124 These recommendations ◯ Report eGFR from serum cystatin C in addition to the
were based on a systematic review of the literature, which in- serum cystatin C concentration in adults and specify
cluded some studies of donors before and after kidney dona- the equation used whenever reporting eGFRcys and
tion.125 There is no evidence to suggest that living kidney eGFRcr-cys.
donor candidates or kidney donors differ from other popula- ◯ Report eGFRcys and eGFRcr-cys in adults using the 2012
tions regarding these recommendations. CKD-EPI cystatin C and 2012 CKD-EPI creatinine-
cystatin C equations, respectively, or alternative cystatin
C-based GFR estimating equations if they have been
shown to improve accuracy of GFR estimates compared
Box 1. Key recommendations from the KDIGO to the 2012 CKD-EPI cystatin C and 2012 CKD-EPI
2012 CKD guideline regarding GFR estimation.124 creatinine-cystatin C equations.
• We recommend using serum creatinine and a GFR estimat- • When reporting serum cystatin C:
ing equation for initial assessment (Recommendation ◯ We recommend reporting serum cystatin C concentra-
1.4.3.1, Grade 1A). tion rounded to the nearest 100th of a whole number
• We suggest using additional tests (such as cystatin C or a when expressed as conventional units (mg/L).
clearance measurement) for confirmatory testing in specific • When reporting eGFRcys and eGFRcr-cys:
circumstances when eGFR based on serum creatinine is ◯ We recommend that eGFRcys and eGFRcr-cys be re-
less accurate (Recommendation 1.4.3.2: Grade 2B). ported and rounded to the nearest whole number and
C.Agnello SE 0255
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 259 of 569 PageID S37
KDIGO Living Kidney Donor Work Group
#:
453
The eGFR based on serum creatinine (eGFRcr) is the rec-
relative to a body surface area of 1.73 m2 in adults ommended initial test. Serum creatinine assays should be
using the units mL/min per 1.73 m2. traceable to the international reference standard. In North
◯ We recommend eGFRcys and eGFRcr-cys levels less America, Europe, and Australia, the 2009 CKD CKD-EPI
than 60 mL/min per 1.73 m2 should be reported as creatinine equation should be used unless other equations
“decreased.” have been shown to be more accurate. eGFRcr using the
• We suggest measuring GFR using an exogenous filtration
2009 CKD-EPI creatinine equation has minimal bias at nor-
marker under circumstances where more accurate as-
certainment of GFR will impact on treatment decisions mal GFR; however, it is imprecise (Figure 5), thus it is most
(Recommendation 1.4.3.8, Grade 2B). useful for an initial evaluation.128 In regions other than
North America, Europe, and Australia, the 2009 CKD-EPI
creatinine equation is less accurate. In these regions, other
equations are recommended if they are more accurate than
GFR as an Index of Kidney Function the 2009 CKD-EPI creatinine equation.
The level of GFR is widely accepted as the best overall GFR estimating equations are developed using regression
index of kidney function in health and disease. The foun- methodologies to relate the mGFR to steady state serum cre-
dations for this acceptance are the well-known relation- atinine concentration and a combination of demographic
ships of alterations in kidney structure and GFR in kidney and clinical variables as surrogates of the non-GFR determi-
disease, and well known pathophysiologic relationships nants of serum creatinine. By definition, GFR estimates using
of kidney disease complications to decreased GFR. Nor- serum creatinine concentration are more accurate in estimat-
mative levels of GFR are expressed per 1.73 m2 because ing mGFR than the serum creatinine concentration alone in
GFR is proportional to kidney size, which is proportional the study population in which they were developed. Sources
to body size. Adjusting GFR to body surface area (BSA) re- of error in GFR estimation from serum creatinine concentra-
duces the variability in GFR in healthy individuals, allowing tion include nonsteady-state conditions, nonGFR determi-
communication of GFR threshold for decision-making that nants of serum creatinine, measurement error at higher GFR,
can applied to most donors across the usual distribution of and interferences with the creatinine assays (Table 12). GFR
body size. estimates are less precise at higher GFR levels than at lower
Based on a large body of evidence, mean GFR in healthy levels. The clinician should remain aware of caveats for any
young adult white individuals is approximately 125 mL/min creatinine-based estimating equation which may influence
per 1.73 m2, with a wide range.126 There is some evidence the accuracy in a given individual.
that the normal level of GFR varies among ethnic groups.127 A variety of confirmatory tests for GFR are available. In
GFR is affected by numerous physiologic and pathologic the general population, the 2012 KDIGO guideline suggests
conditions and varies with time of day, dietary protein in- confirmation of GFR with either GFR estimation using
take, exercise, age, pregnancy, obesity, hyperglycemia, cystatin C or a clearance measurement in specific circum-
use of antihypertensive drugs, surfeit or deficit of extracel- stances when eGFR based on serum creatinine is less accurate
lular fluid, and acute and chronic kidney disease. Despite (Box 1, 2012 CKD Recommendation 1.4.3.2). KDIGO further
these limitations, no other measure has been proposed as
an overall index of kidney function in the general popula-
tion or in kidney donor candidates. Thus, it is important
that the evaluation of kidney function in kidney donor
candidates take into account factors that can affect GFR.
Measurement Methods
It is not possible to directly measure GFR in humans; thus,
the “true” GFR cannot be known with certainty. GFR can be
measured indirectly as the clearance of exogenous filtration
markers or estimated from serum levels of endogenous filtra-
tion markers, but both measured GFR (mGFR) and esti-
mated GFR (eGFR) are associated with error in their
determination. We recommend that the transplant program
use the best available method to assess GFR in donor candi-
dates, recognizing that at many centers, more than one
method may be available. The accuracy of various methods
for measuring and estimating GFR is not known with suffi-
cient certainty to define specific threshold for each method.
The KDIGO 2012 CKD guidelines for GFR evaluation in FIGURE 5. Performance of the CKD-EPI equation in estimating
measured GFR. The figure shows the difference between measured
the general population recommend expressing kidney func- and estimated GFR (bias) versus estimated GFR in an external valida-
tion as GFR and not as serum creatinine concentration, and tion dataset (N = 3896). A smoothed regression line is shown with
recommend expressing GFR in mL/min per 1.73 m2 rather the 95% CI. CI, confidence interval; CKD-EPI, Chronic Kidney Dis-
than mL/min.124 The guidelines recommend 2-stage testing ease Epidemiology Collaboration; GFR, glomerular filtration rate.
Copyright © 2009 American College of Physicians and reprinted with
(initial testing followed by confirmatory testing as necessary). permission from Levey AS, Stevens LA, Schmid CH, et al. A new
The WG concluded that these general recommendations equation to estimate glomerular filtration rate. Ann Intern Med.
were applicable to living kidney donor candidates. 2009;150:604-612.128
C.Agnello SE 0256
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 260 of 569 PageID #:
S38 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 454 www.transplantjournal.com
TABLE 12.
Sources of error in GFR estimation using creatinine
Source of error Example
Non–steady state AKI
Non-GFR determinants of SCr that differ from study populations
in which equations were developed
• Factors affecting creatinine generation Race/ethnicity other than United States and European black and white
Extremes of muscle mass
Extremes of body size
Diet and nutritional status
• High protein diet
• Creatinine supplements
Muscle wasting diseases
Ingestion of cooked meat
• Factors affecting tubular secretion of creatinine Decrease by drug-induced inhibition
• Trimethoprim
• Cimetidine
• Fenofibrate
• Factors affecting extra-renal elimination of creatinine Dialysis
Decrease by inhibition of gut creatininase by antibiotics
Increased by large volume losses of extracellular fluid
Higher GFR Higher biological variability in non-GFR determinants relative to GFR
• Higher measurement error in SCr and GFR
Interference with creatinine assay Spectral interferences (eg, bilirubin, some drugs)
Chemical interferences (eg, glucose, ketones, bilirubin, some drugs)
AKI, acute kidney injury; GFR, glomerular filtration rate; SCr, serum creatinine.
Adapted with permission from Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease.
Kidney Int 2013:1–150.124
suggests measuring GFR using an exogenous filtration marker performance for eGFR using serum creatinine (eGFRcr) or the
under circumstances where more accurate ascertainment of combination of creatinine and cystatin C (eGFRcr-cys). Very high
GFR will impact treatment decisions (Box 1, 2012 CKD Rec- posttest probabilities provide reassurance that mGFR is above
ommendation 1.4.3.8), including the evaluation of living or- the threshold level for decision-making, while very low posttest
gan donors). Based on these recommendations, the WG probabilities provide reassurance that mGFR is below the
concluded that confirmation of GFR using the most accurate threshold levels for decision-making. Transplant programs
method available at the transplant center. In the United can determine what posttest probabilities are sufficient for
States, OPTN policy requires a clearance measurement (mea- clinical decision-making in the absence of mGFR and mCrCl.
sured creatinine clearance [mCrCl] or mGFR) for confirma- One study validating these computations in donor candidates
tion of GFR. has been reported.131 Future studies should address prediction
Many methods for mGFR determination using exogenous accuracy among racial and ethnic groups for whom the accu-
filtration markers and clearance calculations are available, racy of eGFR is less certain (eg, nonblack, nonwhite persons).
with variable accuracy. Recommendations for specific methods In general eGFRcys is not more accurate then eGFRcr;
are based on a recent systematic review.129 mGFR is not however using 2 filtration markers improves precision of
available at all centers, so other alternatives are acceptable. GFR estimates compared with using either marker alone;
mCrCl is less accurate than mGFR,129 but it is acceptable thus eGFRcr-cys is generally recommended over eGFRcr or
if mGFR is not available. mCrCl overestimates mGFR due eGFRcys.132,133 Advantages of cystatin C compared with cre-
to creatinine secretion.130 The magnitude of overestimation atinine are that cystatin C is not affected by muscle mass and
is 15% or more at normal GFR, based on older data using current equations do not require specification of race. There-
nonstandardized serum creatinine assays. The magnitude fore, eGFRcys maybe more accurate than eGFRcr-cys in people
of overestimation may be higher using standardized assays. with very large or very small muscle mass, very high or very
In principle, mCrCl is available worldwide, however, in low meat intake, or race-ethnicity other than black (African
some donor candidates, mCrCl may not be available due American or African European) or white. If cystatin C is
to logistical difficulties in collecting or transporting a timed measured, cystatin C assays should be traceable to interna-
urine collection. tional reference standard (which is in the early stages of im-
A recent study suggests that eGFR may be sufficiently ac- plementation) and the 2012 CKD-EPI eGFRcys equation or
curate for decision-making without the need for mGFR in eGFRcr-cys equation should be used unless other equations
many cases.8 A web-based calculator is available to compute have been shown to be more accurate. If cystatin C is not
posttest probabilities for mGFR above or below threshold available, eGFRcr can be used for decision-making. As with
probabilities for decision-making: http://ckdepi.org/equations/ creatinine, sources of error in GFR estimation from serum
donor-candidate-gfr-calculator/. Post-test probabilities are cystatin C concentration include non–steady-state conditions,
computed from pretest probabilities for mGFR and test nonGFR determinants of serum cystatin C, measurement
C.Agnello SE 0257
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 261 of 569 PageID S39
KDIGO Living Kidney Donor Work Group
#:
455
TABLE 13.
Sources of error in GFR estimation using cystatin C
Source of error Example
Non–steady state AKI
Non-GFR determinants of SCysC that differ from study populations in which
equations were developed
• Factors affecting cystatin C generation Race/ethnicity other than United States and European black and white
Disorders of thyroid function
Administration of corticosteroids
Other hypothesized factors based on epidemiologic associations
(diabetes, adiposity)
• Factors affecting tubular reabosrption of cystatin C None identified
• Factors affecting extra-renal elimination of cystatin C Increased by severe decrease in GFR
Higher GFR Higher biological variability in non-GFR determinants relative to GFR
Higher measurement error in SCysC and GFR
Interference with cystatin C assay Heterophilic antibodies
AKI, acute kidney injury; GFR, glomerular filtration rate; SCysC, serum cystatin C.
Adapted with permission from Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease.
Kidney Int 2013:1–150.124
error at higher GFR, and interferences with the cystatin C compared with the usual level for young adults, but does not
assays (Table 13). meet the KDIGO criterion for CKD.
Single (“divided” or “split”) kidney GFR can be assessed GFR declines with age, although the cause of decline is not
by radionuclide imaging, but is not required in all kidney known and the rate of decline appears widely variable. Most
donor candidates. However, all kidney donor candidates data are based on cross-sectional studies, in which mean GFR
undergo kidney imaging to detect parenchymal, vascular or is lower in older populations than in young populations. Other
urologic abnormalities, and asymmetry in kidney size sug- kidney functions are also lower in older populations (eg, renal
gests asymmetry in kidney function. plasma flow, maximal urinary concentration) and kidney struc-
ture is altered in older populations (eg, cortical atrophy, global
Selection: Criteria for Acceptable Predonation GFR
glomerulosclerosis, nephrosclerosis). There is debate about
GFR in the General Population whether abnormalities in kidney function and structure in
GFR in young men and women of 90 mL/min per 1.73 m2 older people represents normal aging or disease.
or greater is generally considered normal.124 GFR between Decreased GFR in the general population is associated
60 and 89 mL/min per 1.73 m2 is considered to be decreased with a higher risk of complications of CKD, including ESKD,
FIGURE 6. Complications of CKD according to baseline eGFR and albuminuria. The data above were derived using creatinine-based eGFR
(eGFRcr) estimated with the MDRD Study equation.135 Comparable data are not available for mGFR. However, studies using more accurate
GFR estimates confirm these results. For the outcomes of ESKD, all-cause mortality and cardiovascular mortality, any given reduced level of eGFR
is associated with a greater increase in the risk of these outcomes if the 2009 CKD-EPI equation is used to estimate eGFRcr.136 The increase in risk
is even greater if cystatin C is used to estimate GFR, either with or without creatinine (eGFRcr-cys or eGFRcys), compared with eGFRcr137 The 3 lines
represent severe, moderate, and normal/mild albuminuria (top to bottom, respectively). CKD, chronic kidney disease; CKD-EPI, Chronic Kidney
Disease Epidemiology Collaboration; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; GFR, glomerular filtration
rate. MDRD, Modification of Diet in Renal Disease. Reprinted with permission from Levey AS, de Jong PE, Coresh J, et al. The definition, clas-
sification, and prognosis of chronic kidney disease: a KDIGO Controversies Conference report. Kidney Int. 2011;80:17-28.135
C.Agnello SE 0258
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 262 of 569 PageID #:
S40 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 456 www.transplantjournal.com
cardiovascular disease (CVD) and death. In general popula- and 8). This analysis demonstrates that lower eGFR is associ-
tions, compared with a reference eGFR of 95 mL/min per ated with increased lifetime risk for ESKD in all demographic
1.73 m2, the RR for complications related to decreased eGFR subgroups. For eGFR of 90 mL/min per 1.73 m2 or greater
is apparent between 60 and 75 mL/min per 1.73 m2 and is and other optimal characteristics (see above), lifetime risk for
exponentially higher at lower eGFR.134 Similar relation- white men and white women was less than 1% at all ages, but
ships of lower eGFR with adverse outcomes have been ob- was higher among young black men and women (Figure 8).
served in subgroups including patients with known CKD Lifetime risk for eGFR 60 to 89 mL/min per 1.73 m2 was less
(Figure 6).134-137 KDIGO 2012 guideline defines GFR less than 1% at ages older than 60 years. While these displays
than 60 mL/min per 1.73 m2 for 3 months or more as are useful for visualizing the impact of baseline eGFR on
satisfying the criteria for CKD. GFR 15 to 30 mL/min per ESKD risk, we endorse consideration of eGFR as part of the
1.73 m2 is defined as severely reduced, and GFR less than assessment of predicted long-term ESKD risk based on a do-
15 mL/min per 1.73 m2 is defined as kidney failure. However, nor candidate’s complete demographic and health profile (as
the association of lower eGFR with a higher risk of adverse opposed to consideration of single risk factors in isolation).
outcomes may be related to other conditions that co-occur
with low GFR, such as hypertension, diabetes and CVD. GFR after Kidney Donation
Lower GFR in older people is associated with increased risk GFR declines after kidney donation. A person with a
for CKD outcomes, including ESKD, CVD and death. The predonation GFR of at least 90 mL/min per 1.73 m2 would
RR for these outcomes in older people with lower eGFR be expected to have a 1-year postdonation GFR of at least
compared with the reference eGFR is less than the RR in 60 mL/min per 1.73 m2. In general, a donor immediately
younger people, however the increment in absolute risk is loses approximately 50% of renal mass, but there is rapid
higher in older people than in younger people.138 compensatory hyperfiltration leading to a net reduction in
A recent meta-analysis based on data from nearly 5 million GFR of approximately 30% (25% to 40%) after donation
healthy persons identified from 7 general population cohorts (decrement in GFR of 25 to 40 mL/min per 1.73 m2).139-141
who are similar to kidney donor candidates found that lower In prior guidelines a GFR level of 80 mL/min is frequently
GFR (in the absence of donation) is associated with an in- cited as the minimal threshold for an acceptable level of kid-
creased risk for ESKD over median cohort follow-up of 4 ney function for donation.38,142 Limited data show a higher
to 16 years.7 After calibration to annual ESKD incidence in risk for lower GFR after donation among kidney donors with
the US healthy population, variations in the projected lower predonation GFR.3 (Evidence Report Table 16, SDC,
15-year and lifetime risks of ESKD based on level of eGFR http://links.lww.com/TP/B434, and Supplemental Appendix
were generated according to age, sex, and race for healthy Table D13, SDC, http://links.lww.com/TP/B432).
persons (assuming systolic BP (SBP) 120 mm Hg, urine There is theoretical justification for concern about de-
albumin-to-creatinine ratio (ACR) 4 mg/g [0.4 mg/mmol], velopment of kidney disease after nephrectomy. In experi-
BMI 26 kg/m2, and absence of diabetes mellitus) (Figures 7 mental animals, hemodynamic alterations associated with
FIGURE 7. Estimated 15-year incidence (%) of ESKD in the United States according to baseline eGFR and demographic profile from the CKD-PC.
*The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages 20, 30, 40, 50, 60,
70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no diabetes mellitus or antihyper-
tensive medication use. These were selected as being representative of recent US living kidney donors where, with the exception of eGFR,
there was little variation in health characteristics by age. ACR, albumin-to-creatinine ratio; BMI, body mass index; CKD-PC, Chronic Kidney
Disease-Prognosis Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; SBP, systolic blood pressure.
Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor candidate. N Engl J Med.
2016;374:411-421.7
C.Agnello SE 0259
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 263 of 569 PageID S41
KDIGO Living Kidney Donor Work Group
#:
457
FIGURE 8. Estimated lifetime incidence (%) of ESKD in the United States according to baseline eGFR and demographic profile from the CKD-PC.
*The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages 20, 30, 40, 50, 60,
70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no diabetes mellitus or antihyperten-
sive medication use. These were selected as being representative of recent US living kidney donors where, with the exception of eGFR, there
was little variation in health characteristics by age. Lifetime risk projections are based on 15 years of follow-up data and calibrated to the inci-
dence of ESKD in the low-risk population, and thus are likely imprecise. ACR, albumin-to-creatinine ratio; BMI, body mass index; CKD-PC,
Chronic Kidney Disease-Prognosis Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; SBP, systolic
blood pressure. Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor candidate. N Engl
J Med. 2016;374:411-421.7
hyperfiltration after reduction in renal mass are followed by matched donors (risk attributable to donation of 26.9 per
development of structural and functional abnormalities asso- 10 000).30 In this study, the incidence of ESKD was higher
ciated with kidney disease. In general, the severity of reduc- in individuals who are older versus younger at the time of do-
tion in renal mass is directly associated with the rate of nation, in men versus women, in blacks versus whites, and in
development of subsequent kidney disease. A recent study biologically related versus unrelated donors, but risk based
in humans documents similar hemodynamic alterations asso- on predonation eGFR was not reported. Based on these find-
ciated with hyperfiltration after kidney donation.143,144 ings, the likelihood of a small increase in ESKD risk should
The risk of ESKD after kidney donation does not exceed be discussed with donor candidates; such counseling is en-
ESKD risk in the general population.140,145,146 An analysis dorsed by a 2015 AST Live Donor Community of Practice
of living kidney donors in the United States between 1994 consensus statement,148 and is required in the US by the
and 2003 quantified a postdonation ESKD rate of 0.134 OPTN Informed Consent Policy beginning in 2017.51
per 1000 person-years over an average follow-up of 9.8 years,
which was not higher than the ESKD rate in the general pop- Single Kidney GFR
ulation, even though GFR is lower.147 However, the general Many factors determine the preferred kidney to remove
population is a limited comparison group given that donors for transplantation. If GFR is acceptable, but there are paren-
undergo careful medical evaluation and selection.4 The chymal, vascular or urological abnormalities or asymmetry
ERT identified 2 recent studies suggesting that donation is as- in kidney function, it is preferable to transplant the more se-
sociated with an increase in the risk of ESKD compared to verely affected kidney or the kidney with lesser function (see
risk in nondonors selected for baseline good health, although also chapter 16).
the risk increase is small and the absolute postdonation risk On average, kidney function and size are correlated. The
remains low (Supplemental Appendix Table D5, SDC, average length and volume of a single kidney in healthy
http://links.lww.com/TP/B432). The quality of this evidence adults are approximately 11 cm and 150 mL, respectively,
was rated as moderate. In comparing 1901 kidney donors but vary based on age, sex, and body size.149-151 On average
with 32 621 healthy, demographically matched controls, the normal right kidney is approximately 5% smaller than
Mjøen et al reported that 0.47% of donors (n=9) developed the normal left kidney. Asymmetry in kidney size is generally
ESKD versus 0.07% of healthy nondonors (n=22) over a me- considered as a difference in kidney size greater than 10%
dian 15.2-year follow-up.32 Based on linking 96 217 donors (for example, a difference in kidney length > 1.1 cm or kid-
from the US donor registry and healthy participants drawn ney volume > 15 mL). An equivalent difference in kidney
from the National Health and Nutrition Examination Survey function would be greater than 10% (>55% vs <45% in
III to national ESKD reporting forms, Muzzale et al estimated split kidney function). Based on low quality evidence, 1
that the cumulative incidence of ESKD at 15 years was 30.8 prior guideline suggested considering a radionuclide imag-
per 10 000 in donors compared with 3.9 per 10 000 in ing study if the difference between kidney lengths is greater
C.Agnello SE 0260
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 264 of 569 PageID #:
S42 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 458 www.transplantjournal.com
than 2 cm, and that a difference in function of 10% or Evaluation
greater between the kidneys may be considered signifi-
cant.48 No studies were found meeting criteria for review 6.1: Donor proteinuria should be measured as albuminuria,
not total urine protein.
by the ERT.
6.2: Initial evaluation of donor albuminuria (screening) should
What Prior Guidelines Recommend be performed using urine albumin-to-creatinine ratio (ACR)
in a random (untimed) urine specimen.
Some guidelines recommend that GFR of 80 mL/min or 6.3: Donor albuminuria should be confirmed using:
greater is acceptable for donation, based on the level of
• Albumin excretion rate (AER, mg/day [mg/d]) in a timed
GFR in the donor (not adjusted for BSA) that was associated urine specimen
with acceptable outcomes in the recipient, not the donor.152
• Repeat ACR if AER cannot be obtained.
Alternatively, some guidelines recommend a GFR level within
2 standard deviations of normal for age and sex. In general, Selection
the guidelines do not specify the GFR measurement method
to be used, whether the threshold value should be adjusted 6.4: Urine AER less than 30 mg/d should be considered an ac-
for BSA, or provide standardized reference values based on ceptable level for donation.
sex, race, and age.153 6.5: The decision to approve donor candidates with AER 30
to 100 mg/d should be individualized based on demo-
A 2007 survey of practices by transplant programs in the
graphic and health profile in relation to the transplant
United States revealed that approximately 90% of pro- program’s acceptable risk threshold.
grams used mCrCl to measure kidney function, while the 6.6: Donor candidates with urine AER greater than 100 mg/d
other 10% of programs used the clearance of an exogenous should not donate.
filtration marker, and that approximately 67% of trans-
plant programs used a threshold of 80 mL/min or more to RATIONALE
accept donors, while 25% used a threshold based on age
and sex.154 Evaluation
In our view, there is not sufficient evidence to justify a sin- The goals of the evaluation of albuminuria in living donor
gle threshold value of 80 mL/min not adjusted for BSA, nor candidates are to:
age-specific thresholds. In contrast, our recommendations
are more consistent with accepted measurement methods • Provide an accurate assessment of the amount of albuminuria and
and thresholds in general clinical practice, and acknowledge long-term risk of ESKD based on albuminuria and other factors.
that there is variation in GFR measurement methods and un- • Exclude donor candidates whose postdonation risk is ex-
certainty in the appropriate threshold to accept or decline do- pected to exceed the acceptable risk threshold for ESKD estab-
nor candidates. For this reason, we recommend GFR lished by the transplant program.
• Provide counseling regarding level of risk for donor candidates
measurement by urinary or plasma clearance of specific
whose long-term risk for ESKD is expected to be below the ac-
exogenous filtration markers, which are known to be more ceptable risk threshold established by the transplant program.
accurate than mCrCl, but allow other methods. We recom- • Provide counseling regarding follow-up of albuminuria after
mend a higher threshold value of GFR (≥90 mL/min per donation.
1.73 m2) to routinely accept a donor candidate, and lower
threshold value of GFR (<60 mL/min per 1.73 m2) to rou- In this section, recommendations are based on physio-
tinely decline a donor candidate, and a wide intermediate logical principles and recommendations for general clinical
range of GFR (60-89 mL/min per 1.73 m2) in which trans- practice from the 2012 KDIGO CKD guideline.124 There is
plant programs can individualize decisions based on other no evidence to suggest or a reason to think that kidney
risk factors. Of note, this intermediate range would gener- donors differ from the general population regarding these
ally include a mCrCl of 80 mL/min as well as previously recommendations.
recommended age and sex thresholds for mGFR.
Proteinuria as a Marker of Kidney Damage
RESEARCH RECOMMENDATIONS Urine protein is composed of small amounts of high molec-
ular weight proteins (principally albumin) that are not nor-
• Evaluate the accuracy of eGFRcr, eGFRcys and eGFRcr-cys for mally filtered, low molecular weight serum proteins that are
the prediction of mGFR in the evaluation and selection of liv- normally filtered by the glomeruli and reabsorbed by the tu-
ing donor candidates. bules, and proteins secreted by the urinary tract.
• Evaluate long-term risks, including lifetime risk of ESKD, in Increased urinary protein is generally considered a marker
living donor candidates and living donors according to
of kidney damage: albuminuria reflects increased permeabil-
predonation GFR.
ity of the glomeruli (glomerular proteinuria), and low molecu-
lar weight proteinuria reflects decreased tubular reabsorption
CHAPTER 6: PREDONATION ALBUMINURIA (tubular proteinuria). CKD due to either glomerular or
The ERT search parameters did not identify evidence tubulointerstitial diseases is generally associated with both glo-
from eligible studies pertinent to the recommendations in merular and tubular proteinuria (albuminuria and low molec-
chapter 6 and therefore the following recommendations ular weight proteinuria). Some tubulointerstitial diseases may
are “Not Graded.” Some of the recommendations extrapo- cause predominantly tubular proteinuria, including Dent dis-
lated from the 2012 KDIGO CKD Guideline124 were not ease, toxicity due to heavy metals (eg, cadmium and lead) or
part of the ERT review for this guideline and as such they aristolochic acid (Balkan and Chinese herb) nephropathy,
are also “Not Graded.” Sjogren syndrome, multiple myeloma or hereditary diseases
C.Agnello SE 0261
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 265 of 569 PageID S43
KDIGO Living Kidney Donor Work Group
#:
459
associated with Fanconi syndrome, and acute tubular necro- 10-fold among individuals and during the day. The KDIGO
sis. Conditions other than kidney disease can also cause pro- CKD guideline therefore recommends that clinical laboratories
teinuria: low molecular weight proteinuria may also reflect measure creatinine when albumin is requested, and express the
overproduction (eg, light chain proteinuria in lymphoprolif- results as ACR in addition to albumin concentration. Indexing
erative disorders) and high and low molecular weight pro- urine albumin by urine creatinine concentration overcomes
teins may arise from increased secretion of urinary tract variation due to urine concentration and dilution, but intro-
proteins (due to lower urinary tract diseases). duces variation by creatinine generation.
Urine albumin is the preferred measure of urine protein for Recently, some investigators have proposed estimating cre-
assessment of kidney damage. Tests for total urine protein can- atinine excretion rate and multiplying this quantity by ACR
not be standardized because they are not traceable to a standard to estimate AER.155 The lower limit of detection for urine albu-
reference material due to the varying composition of urine pro- min in the clinical laboratory where the test is performed can
tein. Current efforts to standardize albuminuria assessment be used for computation of urine ACR if the clinical laboratory
are directed to establishing traceability of tests for urine albu- reports “below the detectable limit.” Factors affecting urine
min to standardized reference material for serum albumin. ACR in addition to kidney disease are shown in Table 14.
Other urine proteins are less well standardized than albumin. One study reported excellent performance of ACR to detect
The albumin loss rate (hereafter referred to as albumin ex- AER of 30 mg/d. The area under the receiver operator curve
cretion rate, AER) is not regulated in health and is widely ac- was 0.93.156 An ACR threshold of ≥10 mg/g was associated
cepted as a marker of kidney damage. Increased AER is with sensitivity and specificity of 88% each for detecting AER
associated with a wide range of complications and increased ≥30 mg/d. There was minor variation in area under the receiver
AER is one of the criteria for the definition of CKD. In dia- operator curve based on age, sex, race, and body weight.
betic kidney disease and other glomerular diseases, increased
AER generally occurs before the decline in GFR. Urine Protein-to-Creatinine Ratio (PCR)
Tests for total urine protein cannot substitute for tests for
Measurement Methods urine albumin. PCR is less sensitive than ACR, so even nega-
The KDIGO 2012 CKD guideline for the evaluation of albu- tive tests must be confirmed by tests for albumin. Increased
minuria in the general population recommends 2-stage testing PCR suggests increased ACR, but nonalbumin protein can
(initial testing followed by confirmatory testing).124 The current cause a positive test, so positive tests should be confirmed
living donor guideline WG concluded that these general rec- by tests for albumin. Patients with elevated PCR and negative
ommendations were applicable to kidney donor candidates. tests for albumin may have tubular proteinuria, light chain
Initial tests, in order of preference, and the rationale are de- proteinuria or urinary tract disease. Specific assays are avail-
scribed below. In all cases an early morning urine sample is able for α1-microglobulin, β2 microglobulin, monoclonal
preferred as it minimizes variation due to diurnal variation heavy or light chains.
in albumin excretion and urine concentration.
Reagent Strip Urinalysis for Total Protein with
Urine Albumin-to-Creatinine Ratio (ACR) Automated Reading
The rationale for preferring ACR to albumin concentration Reagent strips allow point-of-care, semi-quantitative as-
is that urine concentration and dilution can vary by more than sessment of total urine protein concentration. Reagent strips
TABLE 14.
Factors affecting urinary ACR
Factor Examples of effect
Preanalytical factors
• Transient elevation in albuminuria Menstrual blood contamination
Symptomatic UTI
Exercise
Upright posture (orthostatic proteinuria)
Other conditions increasing vascular permeability (eg, septicemia)
• Intraindividual variability Intrinsic biological variability
Genetic variability
• Preanalytical storage conditions Degradation of albumin before analysis
• Nonrenal causes of variability in creatinine excretion Age (lower in children and older people)
Race (lower in white than black people)
Muscle mass (eg, lower in people with amputations, paraplegia, muscular dystrophy)
Gender (lower in women)
• Changes in creatinine excretion Non–steady state for creatinine (AKI)
Analytical factors
• Antigen excess (“prozone”) effect Samples with very high albumin concentrations may be falsely reported as low or
normal using some assays
ACR, albumin-to-creatinine ratio; AKI, acute kidney injury; UTI, urinary tract infection.
Adapted with permission from Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease.
Kidney Int 2013:1–150.124
C.Agnello SE 0262
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 266 of 569 PageID #:
S44 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 460 www.transplantjournal.com
(“dipsticks”) are more sensitive to albumin than other pro- relationships of high albuminuria with adverse outcomes
teins, but lack specificity. Automated readers are more accu- have been observed in subgroups including patients
rate than manual reading of reagent strips. with known CKD (Figure 6).134-137 KDIGO 2012 CKD
guideline defines AER >30 mg/d for 3 months or more as
Reagent Strip Urinalysis for Total Protein with Manual satisfying the criteria for CKD. AER less than 30 mg/d in
Reading, if the Above Measures are not Available young men and women is considered normal to mildly
Because of variability in urine ACR and its relationship to increased, with 10 to 29 mg/d considered as “high
urine AER, the WG recommends confirmation in all cases. normal”; AER 30 to 300 mg/d is defined as moderately
The preferred confirmatory test is urine AER, expressed as increased compared with the young adult level; and AER
mg/d. If urine AER is not available, a repeat ACR is accept- greater than 300 mg/d is defined as severely increased
able. Consistent with the 2012 KDIGO CKD guideline, test- compared with the young adult level. Approximate ranges
ing for specific urine proteins such as α1-microglobulin, β2 for other measures of urine protein are as shown in
microglobulin, monoclonal heavy or light chains (also Table 15. The association of higher albuminuria with higher
known as “Bence Jones” proteins) can be undertaken if sig- risk of adverse outcomes may be related to other conditions
nificant nonalbumin proteinuria is suspected. These assays that co-occur with high albuminuria, such as hypertension,
can be performed at the same time as tests for albuminuria. diabetes and CVD. The RR for these adverse CKD out-
comes (ESKD, CVD, death) in older people with higher
Selection: Criteria for Acceptable Predonation urine ACR compared with the reference urine ACR is less
Albuminuria than the RR in younger people; however the increment in
absolute risk in older people is higher in older people than
AER in the General Population in younger people.138
The normal level of AER in healthy young men and A recent meta-analysis based on data from nearly 5 million
women is less than 10 mg/d. The coefficient of variation for healthy persons identified from 7 general population cohorts
repeated measurements is approximately 30%.157 Because found that each 10-fold increase in urinary ACR was associ-
of the high coefficient of variation, repeated measurements ated with 3 times the risk of ESKD over median cohort
are preferred for assessment of albuminuria. follow-up of 4 to 16 years, although the finding was not
AER rises with age, although the cause of rise is not statistical significant (95% Lower Confidence Limit adjusted haz-
known and the rate of rise appears widely variable. Most ard ratio [aHR] 95% Upper Confidence Limit; 0.992.948.75).7 Af-
data are based on cross-sectional studies and mean AER is ter calibration to annual ESKD incidence in the US healthy
higher in older populations than in young populations. As population, variations in the projected 15-year and lifetime
discussed in chapter 5, there are often abnormalities in kid- risks of ESKD based on urine ACR were generated according
ney function and structure in the elderly and there is debate to age, sex, and race for healthy persons (assuming age-
about whether higher AER in older people represents nor- specific eGFR, SBP 120 mm Hg, BMI 26 kg/m2, and absence
mal aging or disease. of diabetes mellitus; Figures 9 and 10). This analysis demon-
Higher albuminuria in the general population is associated strates that higher albuminuria is associated with higher life-
with a higher risk of complications of CKD, including ESKD, time risk of ESKD in all subgroups, with higher risk in men
CVD and death. In general populations, compared with a ref- than women and blacks than whites. For urine ACR less than
erence ACR of 5 mg/g (0.5 mg/mmol), the RR for complica- 10 mg/g and other optimal risk factors (see above), lifetime
tions related to increased ACR rises at higher ACR, without risk for white men and white women was less than 1% at all
an apparent threshold when expressed on the log scale.134 ages, but exceeded 2% for black men younger than 40
The risk of higher ACR is independent of the eGFR. Similar (Figure 10). For urine ACR less than 30 mg/g, the lifetime
TABLE 15.
Relationship among categories for albuminuria and proteinuria
Categories
Measure Normal to mildly increased (A1) Moderately increased (A2) Severely increased (A3)
AER (mg/24 h) <30 30-300 >300
PER (mg/24 h) <150 150-500 >500
ACR
(mg/mmol) <3 3-30 >30
(mg/g) <30 30-300 >300
PCR
(mg/mmol) <15 15-50 >50
(mg/g) <150 150-500 >500
Protein reagent strip Negative to trace Trace to + + or greater
Albuminuria and proteinuria can be measured using excretion rates in timed urine collections, ratio of concentrations to creatinine concentration in spot urine samples, and reagent strips in spot urine
samples. Relationships among measurement methods within a category are not exact. For example, the relationships between AER and ACR and between PER and PCR are based on the assumption that
average creatinine excretion rate is approximately 1.0 g/d or 10 mmol/d. The conversions are rounded for pragmatic reasons. (For an exact conversion from mg/g of creatinine to mg/mmol of creatinine,
multiply by 0.113.) Creatinine excretion varies with age, sex, race, and diet; therefore the relationship among these categories is approximate only. ACR less than 10 mg/g (<1 mg/mmol) is considered
normal; ACR 10 to 30 mg/g (1-3 mg/mmol) is considered “high normal.” ACR greater than 2200 mg/g (>220 mg/mmol) is considered “nephrotic range.” The relationship between urine reagent strip results
and other measures depends on urine concentration. ACR, albumin-to-creatinine ratio; AER albumin excretion rate; PCR, protein-to-creatinine ratio; PER, protein excretion rate. Adapted with permission
from Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int 2013:1–150.124
C.Agnello SE 0263
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 267 of 569 PageID S45
KDIGO Living Kidney Donor Work Group
#:
461
FIGURE 9. Estimated 15-year incidence (%) of ESKD in the United States according to baseline albumin-to-creatinine ratio (ACR, mg/g) and
demographic profile from the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per
1.73 m2 for ages 20, 30, 40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no
diabetes mellitus or antihypertensive medication use. These were selected as being representative of recent US living kidney donors where, with
the exception of eGFR, there was little variation in health characteristics by age. BMI, body mass index; CKD-PC, Chronic Kidney Disease-Prognosis
Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; SBP, systolic blood pressure. Reprinted from Grams ME,
Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor candidate. N Engl J Med. 2016;374:411-421.7
risk was less than 1% in white men at age >50 years, black as part of the assessment of predicted long-term ESKD risk
men at age >70, and black women at age >60. While these based on a donor candidate’s complete demographic and
displays are useful for visualizing the associations of base- health profile (as opposed to consideration of single risk
line ACR with ESKD risk, we endorse consideration of ACR factors in isolation).
FIGURE 10. Estimated lifetime incidence (%) of ESKD in the United States according to baseline albumin-to-creatinine ratio (ACR, mg/g) and
demographic profile from the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per
1.73 m2 for ages 20, 30, 40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no
diabetes mellitus or antihypertensive medication use. These were selected as being representative of recent US living kidney donors where,
with the exception of eGFR, there was little variation in health characteristics by age. Lifetime risk projections are based on 15 years of follow-up
data and calibrated to the incidence of ESKD in the low-risk population, and thus are likely imprecise. BMI, body mass index; CKD-
PC, Chronic Kidney Disease-Prognosis Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease;
SBP, systolic blood pressure. Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor
candidate. N Engl J Med. 2016;374:411-421.7
C.Agnello SE 0264
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 268 of 569 PageID #:
S46 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 462 www.transplantjournal.com
found that approximately 76% of programs used a PER in a
24-hour urine collection for donor evaluation, and that 36%
used PER > 150 mg/d as a threshold for donor exclusion (un-
less proteinuria is postural), while 44% reported higher ex-
clusion thresholds of 300-1000 mg/d.154
By comparison, our recommendations are more consistent
with the recently accepted criterion standard, measurement
methods and thresholds in general clinical practice, but ac-
knowledge that there is variation in ascertainment of albu-
minuria for screening and uncertainty in the appropriate
threshold to accept or decline donor candidates. For these
reasons, we recommend measurement of albumin rather than
total protein, and AER in a timed urine collection rather than
ACR in a spot urine specimen if possible. We recommend an
AER threshold of less than 30 mg/d to routinely accept a do-
nor candidate, which corresponds to normal to mildly in-
creased. We recommend an intermediate range of AER 30
to 100 mg/d corresponding to the lower range for moderately
increased AER, in which to individualize decisions based
FIGURE 11. Proteinuria after kidney donation. Solid line, regression on other risk factors. We acknowledge that AER of 30 to
line; dotted line: 95% confidence interval. Reprinted with permission 100 mg/d meets the criteria for CKD, and past recommen-
of the Massachusetts Medical Society from Ibrahim HN, Foley R, dations have strived to exclude donor candidates with
Tan L, et al. Long-term consequences of kidney donation. N Engl J CKD. We have not excluded candidates solely on the basis
Med. 2009;360:459-469.140
of AER 30 to 100 mg/d because estimated projected
predonation lifetime risk of ESKD in older persons with
Proteinuria after Kidney Donation ACR in this range is very low in the absence of decreased
Some but not all studies demonstrate donors have an in- GFR and other health risk factors.7 Thus, we concluded that
crease in proteinuria compared with nondonor control universal exclusion would not be consistent with a Frame-
groups (Figures 11 to 12).139-141 In prior guidelines a protein work that would allow donation from other candidates with
excretion rate (PER) <150 mg/d was frequently cited as similar risk due to other clinical risk factors.
acceptable for donation.48,50,158,159 This level corresponds We do not require tests of total urine protein in addition to
roughly to AER less than 30 mg/d, which includes normal albumin because there are no accepted normal ranges for
and mildly increased (Table 15).124 However, the risk urine nonalbumin protein excretion; disorders associated
associated with albuminuria in kidney donors is uncertain. with predominant tubular proteinuria (tubulointerstitial kid-
There is theoretical justification for concern about devel- ney disease) and overproduction proteinuria (plasma cell or
opment of kidney disease after nephrectomy. First, in experi- B-lymphocyte disorders) are uncommon, and patients with
mental animals, reduction in renal mass is associated with these disorders usually have other clinical abnormalities that
increased glomerular permeability to albumin followed by would be discovered during the donor evaluation.
other structural and functional abnormalities associated with
kidney disease. Second, given that GFR declines after kidney
donation, the filtered load of albumin would be expected to RESEARCH RECOMMENDATIONS
decline. Unchanged or higher albuminuria after donation • Assess the accuracy of urine ACR compared with AER for
suggests increased albumin filtration per nephron. evaluation and selection of living donor candidates.
In a prior systematic review, the incidence of clinical protein- • Evaluate the association of urine albumin with other kidney
uria after donation was quantified in 42 studies, that followed measures (eg, GFR and kidney size) at the time of donor eval-
4793 living donors for an average of 7 years (range, 2-25 uation and with kidney measures and outcomes (eg, GFR
years).141 There was significant heterogeneity between the stud- change, ESKD, survival) after donation.
ies (P < 0.0001). Some studies reported an incidence of protein-
uria over 20%, whereas in others the incidence was less than
5%. The pooled incidence of proteinuria was 12% (95% CI, CHAPTER 7: PREDONATION HEMATURIA
8-16%). These results were similar in a supplementary analysis The ERT search parameters did not identify evidence from
limited to 9 studies which consistently defined proteinuria as eligible studies pertinent to the recommendations in chapter 7
greater than 300 mg/d based on 24-hour urine. The pooled in- and therefore the following recommendations are “Not
cidence of proteinuria among these 9 studies, which followed a Graded.”
total of 1799 donors for 7 years, was 10% (95% CI, 7-12%). Evaluation
What Prior Guidelines Recommend 7.1: Donor candidates should be assessed for microscopic
Some guidelines recommend that accepted living donor hematuria.
candidates have a PER less than 150 to 300 mg per day, 7.2: Donor candidates with persistent microscopic hematuria
based on the usually accepted normal range, generally with- should undergo testing to identify possible causes, which
out reference to measurement methods. A survey of practices may include:
by transplant programs in the United States reported in 2007 • Urinalysis and urine culture to assess for infection
C.Agnello SE 0265
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 269 of 569 PageID S47
KDIGO Living Kidney Donor Work Group
#:
463
FIGURE 12. Meta-analysis of proteinuria after kidney donation. Controlled studies of proteinuria after kidney donation. The size of each square
is inversely proportional to the variability of the study estimate. *Studies are arranged by the average number of years after donation.
‡Microalbuminuria was assessed by 24-hour urine. †Mathematically pooled results are not presented graphically because of statistical hetero-
geneity between studies. CI, confidence interval. Reprinted with permission from Garg AX, Muirhead N, Knoll G, et al. Proteinuria and reduced
kidney function in living kidney donors: a systematic review, meta-analysis, and meta-regression. Kidney Int. 2006;70:1801-1810.141
• Cystoscopy and imaging to assess for urinary tract 7.4: Donor candidates with IgA nephropathy should not
malignancy donate.
• 24-hour urine stone panel to assess for nephrolithiasis
and/or microlithiasis RATIONALE
• Kidney biopsy to assess for glomerular disease (eg,
thin basement membrane nephropathy, IgA nephropa- Evaluation and Definitions
thy, Alport syndrome) Persistent microscopic hematuria is most often defined as
more than 2 to 5 red blood cells per high-power field of
Selection urinary sediment on 2 to 3 separate occasions, unrelated
7.3: Donor candidates with hematuria from a reversible cause that to exercise, trauma, sexual activity or menstruation.160-163
resolves (eg, a treated infection) may be acceptable for donation. Consensus-based guidelines of the American Urological
C.Agnello SE 0266
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 270 of 569 PageID #:
S48 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 464 www.transplantjournal.com
Association state that while a positive dipstick reading war- automated analyzer has a broad a range of sensitivities
rants microscopic examination to confirm the diagnosis of (32% to 100%) and specificities (from 33% to 100%) for
asymptomatic microhematuria, a positive dipstick alone glomerular causes of microhematuria.161 The presence of
does not define microhematuria, and evaluation should be dysmorphic red blood cells or cellular urinary casts and other
based solely on findings from microscopic examination of clinical information can be used to prioritize the evaluation
urinary sediment.161 Causes of a positive dipstick reading for glomerular causes of hematuria. However, the presence
in the absence of red blood cells in the urine include hemo- of dysmorphic red blood cells does not exclude underlying
globinuria, myoglobinuria, a dilute urine sample, or simply urologic disease.161
a false-positive test. Although isolated microscopic hematuria in young per-
The estimated prevalence of microscopic hematuria varies sons is often considered “benign,” a recent population-
widely from 0.18% to 16%.160 A recent population study of based study of 1.2 million Israeli persons aged 16 to
1.2 million persons aged 16 to 25 years in Israel identified 25 years with up to 35 years of follow-up identified small
prevalent asymptomatic persistent microscopic hematuria but significant increase in long-term renal risk associated
in 0.3% of individuals.163 Persistent microscopic hematuria with persistent asymptomatic isolated microscopic hematu-
may be associated with urologic abnormalities (eg, stones, tu- ria, with ESKD rates of 34.0 versus 2.05 per 100 000
mors) or glomerular disease. The most common glomerular person-years among those with versus without persistent mi-
causes of persistent isolated microscopic hematuria are IgA croscopic hematuria (adjusted HR, 12.418.527.6).163 While
nephropathy, thin basement membrane nephropathy (TBMN) participants were required to have serum creatinine values
and Alport syndrome.164-167 “within the normal range” and 24-hour urine protein less
There are consensus-based guidelines for the evaluation of than 200 mg, this study does not provide information on
asymptomatic microhematuria in the general population. For ESKD risk after comprehensive evaluation and selection in-
example, the 2012 recommendations from the American cluding measured kidney function.
Urological Association161 include assessment of risk factors
for urinary tract malignancies (eg, irritative voiding symptoms, Selection
current or past tobacco use, chemical exposures), radiological The sequence of the evaluation for microscopic hematuria,
evaluation (eg, multiphasic computed tomography urography, like other testing in this guideline, is designed to perform less
without and with intravenous contrast, or magnetic resonance invasive/expensive tests before more invasive/expensive tests,
urography), and cystoscopy in patients age 35 years or older re- and only if the less invasive/expensive tests do not preclude
gardless of history of use of anticoagulation therapy. Urine cy- donation (Figure 13).168 Reversible causes of microscopic
tology and urine biomarkers are not recommended as a part hematuria, for example, treatable urinary tract infection,
of the routine evaluation of asymptomatic microhematuria. should generally not preclude donation. In the absence of a
The presence of dysmorphic urinary red blood cells detected family history suggesting possible TBMN or Aport disease,
by conventional microscopy, phase-contrast microscopy, or additional testing to rule out these causes is generally not
FIGURE 13. Sequential evaluation of microscopic hematuria in living kidney donor candidates. In general, lower risk and less expensive tests
should be performed first, and at each step additional testing should only be performed if necessary. Boxes indicate stopping points in the do-
nor candidate hematuria evaluation. AER, albumin excretion rate; GFR, glomerular filtration rate; hpf, high-power field; RBC, red blood cell.
C.Agnello SE 0267
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 271 of 569 PageID S49
KDIGO Living Kidney Donor Work Group
#:
465
necessary. Please refer to chapter 14 for a related discussion deposition to be relatively common in healthy Japanese
on genetic testing in the donor candidate. living donors, present in 16.1% of living donor allograft
Epidemiological studies of TBMN suggest increased risks biopsies.177 Mesangial IgA deposition was associated with
of hypertension and proteinuria compared with the general a mild degree of microhematuria, mesangial proliferation
population over time, but progression to ESKD is rare and and glomerular macrophage infiltration in some of the af-
thought to require an additional insult.169 Data on outcomes fected individuals, especially with C3 deposition.
of living kidney donor evaluation and donation in persons Persistent hematuria without defined renal histopathology
with TBMN are limited to small series with short-term has been associated with proteinuria after kidney donation.
follow-up.170,171 A series of 512 consecutive donors at a US In a series of 242 living kidney donors at one center in
center identified asymptomatic, microscopic hematuria for Japan, persistent predonation hematuria was identified in
at least 1 month in 2.7% (n = 14). Hematuria resolved after 8.3% (18.6% vs 6% in those with vs without family history
treatment for urinary tract infection in 2. Kidney biopsy of IgA nephropathy or Alport syndrome).178 95% of those
was performed in 10/12, and showed: TBMN (5/12); normal with persistent predonation hematuria continued to have
(2/12); nonhomogeneous basement membrane abnormalities persistent hematuria after donation over median 27 month
(1/12); IgA nephropathy (1/12); and greater than 20% follow-up (compared with 28% of those with predonation
glomerulosclerosis in a patient with a family history of occasional hematuria and 5% without predonation hematu-
Schimke's syndrome (immune-osseous dysplasia). Two of ria). Predonation hematuria was associated with increased
the 4 with TBMN, aged 44 and 53 years, proceeded with likelihood of persistent proteinuria (dipstick ≥ 1+) after do-
donation; after 15 months follow-up, donors were free of nation (without dysmorphic red blood cells: adjusted OR
hypertension, proteinuria, and recipients had “excellent” 3.8; with dysmorphic red blood cells: adjusted OR 12.3).
graft function.170 A Korean series including 5 living do- Predonation hematuria was not associated with postdonation
nors with TBMN defined by predonation biopsy reported GFR, but persistent postdonation hematuria with dysmorphic
favorable short-term outcomes, including mean serum cre- red blood cells was associated with significant GFR decline
atinine 0.94 ± 0.32 mg/dL (83 ± 28.3 μmol/L) and no cases over the study period.
of new-onset hypertension or proteinuria over mean
follow-up period of 34.7 ± 42.5 months.171 What Prior Guidelines Recommend
Notably, TMBN is often defined based on pathological de- Previous guidelines recommend that evaluation of donor
scription rather than as a distinct clinical entity. Carrier states candidates for causes of hematuria include urine culture
for Alport mutations may present as TBMN. High rates of and imaging,48 cystoscopy if older than 40 years,48 urine cytol-
proteinuria (75%) and ESKD (8-30%) have been reported ogy and “complete” urological evaluation.54 A recent Canadian
in female carriers of X-linked Alport syndrome muta- protocol recommends tests of urine culture, urine cytology,
tions.172 A recent study identified adverse kidney outcomes 24-hour urine calcium, metabolic stone workup, and then if
in 234 Alport carriers (including 29 autosomal recessive the cause of hematuria is undetermined, cystoscopy and a na-
and 205 X-linked mutation carriers): ESKD developed in tive kidney biopsy.179 In the absence of an identified cause,
17.5% at a median age of 49 years, and outcomes includ- evaluation by kidney biopsy has been advised if hematuria is
ing ESKD, proteinuria and impaired kidney function were >1 + 48 or possibly caused by glomerular disease38,54
similar in X-linked and autosomal recessive carriers,173 al- While a number of prior living donor guidelines recom-
though the number of autosomal recessive carriers was small. mend kidney biopsy as part of the evaluation of persistent
Among 6 female Alport carriers (5 X-linked, 1 autosomal re- microhematuria before donation,48,180 few articulate criteria
cessive) who donated to their children at several European for donor selection. The 2011 British Transplantation Society
centers and were followed for an average 6.7 years, 3 devel- guidelines offer a “moderate quality” recommendation that
oped new-onset hypertension and 2 developed new-onset of “glomerular pathology precludes donation, with the possible
proteinuria.174 Creatinine clearance remained greater than exception of thin basement membrane disease.”48 Canadian
40 mL/min in all donors after up to 14 years. Thus, while data Blood Service’s protocol for KPD defines IgA nephropathy
are limited, female carriers of X-linked Alport syndrome (ie, and Alport syndrome (including carrier status) as exclusions
COL4A5 mutation) should be discouraged from kidney dona- to donation.179
tion because of their own increased risk of hypertension and The 2013 “Expert Guidelines for the Management of
adverse kidney outcomes even in the absence of donation. Alport Syndrome and Thin Basement Membrane Nephropa-
IgA nephropathy that presents with hematuria and mini- thy” include several consensus-based recommendations re-
mal proteinuria is often a progressive disease.175 In one series lated to living donation selection181: A) “Individuals with
in Hong Kong, 72 consecutive patients with IgA nephropathy TBMN may be kidney donors if they have normal BP,
presenting as hematuria and minimal proteinuria (0.4 g/day or proteinuria, and renal function” and if a biopsy is done
less) were followed for a median of 84 months; 33% devel- and Alport syndrome is excluded.” Close monitoring
oped proteinuria, 26% became hypertensive, and 7% and use of nephroprotective strategies are advised; B) “In-
developed impaired kidney function.176 The presence of dividuals from families with autosomal recessive Alport
hematuria and glomerular IgA deposition is associated syndrome who have only one of the causative mutations
with increased risk of progressive kidney disease even in (parents, offspring, some siblings) may be kidney donors
the absence of other clinical findings.175 For this reason, if they have normal BP, proteinuria levels, and renal func-
there is broad consensus that people with known IgA tion; if coincidental kidney disease has been excluded by
nephropathy should not donate a kidney. Examination of kidney biopsy; and if X-linked Alport syndrome has been
a series of 510 implantation biopsies at a large center in Tokyo excluded by genetic testing.” The document recommends
(including 446 living donors) found latent mesangial IgA “discouraging affected mothers of males with X-linked
C.Agnello SE 0268
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 272 of 569 PageID #:
S50 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 466 www.transplantjournal.com
Alport syndrome from renal donation because of their and any prior investigations or treatments. The frequency
own risk of kidney failure.” of kidney stones varies by sex, race and climate. The over-
all prevalence of kidney stones is approximately 6 to 9% in
RESEARCH RECOMMENDATIONS men, and 3 to 4% in women, and most stones are com-
posed of calcium oxalate.183 Living kidney donors without
• Perform long-term follow-up studies of living donors with in- a predonation history of kidney stones have no difference
frequent clinical conditions including:
in the risk of developing kidney stones after donation, or
◯ Alport female “carrier” state in receiving a urologic procedure for kidney stones after
◯ TBMN donation, compared with selected nondonors matched
◯ Incidental IgA deposition in glomeruli and isolated hematuria for similar baseline health.184
◯ Nephrolithiasis
• These studies should include appropriate controls and exam-
ine endpoints including CKD and kidney failure, premature Asymptomatic Kidney Stones Seen on Imaging
death, and health-related quality of life. Approximately 5% of individuals have evidence of an
asymptomatic kidney stone on CT angiography performed
CHAPTER 8: KIDNEY STONES as part of the donor evaluation.185 Such CT scans may de-
tect very small calcifications in the kidneys in patients who
The ERT search parameters did not identify evidence are asymptomatic and have no history of a clinically recog-
from eligible studies pertinent to the recommendations in nized kidney stone; very small 1 to 2 mm calcifications in
chapter 8 and therefore the following recommendations the renal papillae found on CT scans are referred to as
are “Not Graded.” Randall’s plaques. These plaques have uncertain prognos-
Evaluation tic significance.
8.1: Donor candidates should be asked about prior kidney
stones, and related medical records should be reviewed Evaluation of Donor Candidates and Donors with Prior
if available. or Current Kidney Stones
8.2: The imaging performed to assess anatomy before donor Donor candidates and donors with current or prior kidney
nephrectomy (eg, computed tomography angiogram) stones should have an evidence-based evaluation of nephrolithiasis.
should be reviewed for the presence of kidney stones. For example, the 2014 American Urological Association
8.3: Donor candidates with prior or current kidney stones
should be assessed for an underlying cause.
Guideline provides comprehensive consensus and evidence-
based recommendations for the evaluation of adult patients
Selection with kidney stones186:
8.4: The acceptance of a donor candidate with prior or current 1. A clinician should perform a screening evaluation consisting
kidney stones should be based on an assessment of stone of a detailed medical and dietary history, serum chemistries
recurrence risk and knowledge of the possible conse- and urinalysis on a patient newly diagnosed with kidney or
quences of kidney stones after donation. ureteral stones. (clinical principle)
2. Serum intact parathyroid hormone (PTH) concentration
Counseling should be obtained as part of the screening evaluation if pri-
mary hyperparathyroidism is suspected. (clinical principle)
8.5: Donor candidates and donors with current or prior kid- 3. When a stone is available, a stone analysis should be per-
ney stones should follow general population, evidence- formed at least once. (clinical principle)
based guidelines for the prevention of recurrent stones. 4. Clinicians should obtain or review available imaging studies
to quantify stone burden. (clinical principle)
5. Additional metabolic testing should be performed in high-risk
RATIONALE
or interested first-time stone formers and recurrent stone for-
Evaluation mers. (moderate evidence)
6. Metabolic testing should consist of one or two 24-hour urine
Transplant programs typically assess donor candidates
collections obtained on a random diet and analyzed at mini-
with past or present, symptomatic or asymptomatic kidney mum for total volume, pH, calcium, oxalate, uric acid, citrate,
stones. In a cohort of approximately 2000 living kidney do- sodium, potassium and creatinine. (expert opinion)
nor candidates who underwent computed tomography (CT)
angiograms/urograms at a large US center (mean age, Similarly, the 2016 European Association of Urology guide-
43 years; 92% white; 58% women), 3% of candidates had line also provides comprehensive expert and evidence-based
past symptomatic kidney stones, and 11% had evidence of recommendations on the evaluation of adults with kidney
stones on renal imaging.182 stones,187 as do the Caring for Australians with Renal Impair-
A kidney stone in an individual with a solitary kidney can ment (CARI) guidelines.183
potentially obstruct the ureter, leading to acute kidney injury,
and may result in urgent hospital attention and even surgi-
cal intervention. Donor candidates should have a detailed Risk Factors for Recurrent Stones
evaluation including a careful history and medical record Prospective studies have shown the median recurrence rate
review of any prior or current kidney stones. In the case of kidney stones is 15 per 100 person-years.188 However, the
of a prior history of stones, additional details that should risk of recurrence after a single stone is difficult to predict in
be assessed include the time and location of prior episodes, an individual. Compared with older adults, younger adults
C.Agnello SE 0269
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 273 of 569 PageID S51
KDIGO Living Kidney Donor Work Group
#:
467
have more remaining years to live, and so have a higher life- recurrent kidney stones. Recent systematic reviews and clini-
time chance of kidney stone recurrence. cal practice guidelines summarize this evidence.194,195 For ex-
Characteristics associated with a higher lifetime risk of ample, there is low-strength evidence that increased fluid
stone recurrence include183: intake to achieve a urine output of at least 2 liters per day
• Younger age (<40 years) (vs normal fluid intake) and reduced soft-drink consumption
• A family history of kidney stones lowers the risk of recurrent stones. In patients with multiple
• Frequent, recurrent kidney stones past calcium stones, most of whom increased their fluid in-
Characteristics associated with a lower lifetime risk of stone take, there is moderate-strength evidence that thiazide di-
recurrence include: uretics, citrate supplements, and allopurinol each further
• Older age (≥40 years) reduce the risk of future stones compared with placebo or
• No prior symptoms of kidney stones control, although the benefit from allopurinol seemed limited
• A kidney stone that is less than 15 mm, solitary and to patients with baseline hyperuricemia or hyperuricosuria.
unilateral What Prior Guidelines Recommend
Selection and Management Several prior guidelines and US policy requirements describe
The acceptance of a donor candidate with prior or current evaluation methods and/or acceptance criteria for donor
kidney stones should be based on an assessment of stone re- candidates with prior or current kidney stones.38,48,51,55,179
currence risk and knowledge of the possible consequences Generally, most prior guidelines recommend complete meta-
of kidney stones after donation. bolic testing (serum PTH, 24-urine collection for calcium,
As recommended in chapter 5 (Predonation Kidney Func- phosphate, oxalate, citrate, urate, creatinine and sodium),
tion), when asymmetry in GFR, parenchymal abnormalities and one guideline recommends all such candidates be
(including stones), vascular abnormalities, or urological ab- assessed by a urologist.179 Several prior guidelines recom-
normalities are present but do not preclude donation, the mend the current presence of bilateral kidney stones, mul-
more affected kidney should be used for donation. tiple stones, or nephrocalcinosis precludes donation, while
a current small single stone may be eligible to proceed with
Possible Consequences of Kidney Stones donation.38,54,55,179,196
Kidney stones may be associated with a higher risk of CKD
and ESKD, with possible mechanisms including obstructive RESEARCH RECOMMENDATIONS
uropathy or pyelonephritis, crystal plugs at tips of the renal • Perform follow-up studies of approved donors with current
papilla and parenchymal injury from treatments such as stones, risk factors for recurrent stones, or small calcifications
shockwave lithotripsy.183,189 One or more episodes of kidney discovered on imaging to determine impact of these factors on
stones were associated with a 2-fold higher risk of ESKD in long-term outcomes compared to donors without these char-
one population-based study from Alberta, Canada.190 The acteristics, and also compared to nondonors with similar risk
association was stronger in patients with 2 or more episodes factors.
of kidney stones versus a single episode of kidney stones. A • Develop a tool to estimate the risk of postdonation kidney stones
National Health and Nutrition Examination Survey also re- according to predonation clinical and demographic factors.
ported that a history of kidney stones was associated with
CKD and ESKD, however the effect was largely confined to CHAPTER 9: HYPERURICEMIA, GOUT, AND
women.191 Among 10 678 patients in the Atherosclerosis Risk MINERAL AND BONE DISEASE
in Communities study, nephrolithiasis history was associ- The ERT search parameters did not identify evidence from
ated with a 29% (HR, 1.071.291.54) higher risk of CKD in eligible studies pertinent to the recommendations in chapter 9
demographic-adjusted analyses, but the association was no and therefore the following recommendations are “Not
longer statistically significant after multivariable adjustment Graded.”
(HR, 0.901.091.32;).192 To inform this guideline, CKD-PC ana-
lyzed multiple cohorts (see chapter 1).7 They found the associ- Evaluation
ation between a prior history of kidney stones and ESKD was
not significant in the meta-analysis; for this reason a history of 9.1: Donor candidates should be asked about prior episodes
kidney stones does not appear as a characteristic in the online of gout.
tool to predict the 15-year and lifetime chance of kidney failure
in the absence of donation.7 Counseling
9.2: Donor candidates may be informed that donation is asso-
Ex-vivo Removal of Kidney Stones ciated with an increase in serum uric acid concentration,
There are reports of nephrolithiasis-related adverse which may increase the risk for gout.
events for recipients of an allograft with a stone left in 9.3: Donor candidates and donors with prior episodes of gout
situ.193 There are also reports on the safety and success should be informed of recommended methods to reduce
of ex vivo ureteroscopy to remove stones from explanted their risk of future episodes of gout.
donor kidneys before transplantation.185
RATIONALE
Counseling
Donors and donor candidates who develop kidney stones Hyperuricemia and Gout
should follow general population evidence-based guidelines High serum uric acid concentration is a potent risk factor
for dietary and pharmacologic-based strategies to prevent for gout, for which the 10-year incidence is estimated to be
C.Agnello SE 0270
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 274 of 569 PageID #:
S52 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 468 www.transplantjournal.com
1%, 5%, and 49% for uric acid levels of < 7.0, 7.0-8.9, and should probably be used cautiously in patients with de-
≥ 9.0 mg/L respectively.197,198 A decline in GFR results in creased kidney function including living kidney donors. The
less uric acid excretion and a higher serum uric acid concen- treatment of choice for acute gout is colchicine, however
tration.199,200 These changes are evident with the 25% to the dose of colchicine should be reduced in patients with de-
40% reduction in GFR that occurs after living kidney dona- creased kidney function.
tion.139,201,202 For example, one prospective US cohort study
Metabolic Bone Disease
found that at 6 months after nephrectomy, donors versus
healthy nondonor controls had 8.2% higher serum uric acid The effect of the modest decrease in GFR on the develop-
level [mean values of 5.3 ± 1.1 mg/dL (315.2 ± 65.4 µmol/L; ment of metabolic bone disease among kidney donors is not clear.
standard deviation) vs 4.9 ± 1.2 mg/dL (291.5 ± 71.4 µmol/L); Several recent studies describe changes in measures of bone min-
P < 0.001], that persisted over 36 months of follow-up.139,201 eral metabolism in kidney donors. These changes include a de-
Another study found donors to have 20% higher serum uric cline in the serum concentration of 1, 25-dihydroxyvitamin D
acid concentrations at a mean of 7 years after nephrectomy and phosphate, a decline in tubular phosphate reabsorption,
compared with predonation.203 and a rise in the concentration of serum PTH.139,201,202,208 For
In a study of 1988 living kidney donors from Ontario, example, one study showed that kidney donors had higher serum
Canada, who were followed for a median of 8.8 years (max- concentrations of fibroblast growth factor-23 and greater frac-
imum, 20.8 years), living kidney donors were more likely to tional excretion of inorganic phosphate compared with
be diagnosed with gout compared to matched nondonors nondonor controls.209 The Assessing Long Term Outcomes
with similar baseline health, although the absolute risk re- of Living Donation prospective cohort study found a 23%
mained low (3.5 vs 2.1 events per 1000 person-years; HR higher PTH concentration among 206 donors assessed at
203 6 months postdonation compared with concentrations among
1.21.62.1;). At 8 years, the cumulative incidence of gout
was 1.4% higher in donors compared to nondonors 198 healthy controls (52.7 vs 42.8 pg/mL, respectively)201 that
(3.4% vs 2.0%).203 This report was not reviewed by the persisted at 36-month follow-up.139 Similarly, the Chronic Re-
ERT but would be expected to have a moderate risk of bias nal Impairment in Birmingham study of 68 donors at 2 United
similar to other reported outcomes from this cohort. Based Kingdom centers reported larger increases in serum fibroblast
on this report, some transplant teams may decide to inform do- growth factor-23 and parathyroid hormone concentrations
nor candidates that donation is associated with an increase in compared with prospective changes in these parameters
serum uric acid concentration, which may increase the risk of among healthy nondonors.202
gout. However, the authors of the primary report suggested The long-term effects of these changes on the risk of fractures,
the finding first be corroborated in other studies. In this guide- CVD, or other outcomes important to donors is uncertain,
line we endorse that donor candidates be asked about prior therefore the WG made no recommendations for managing
gout episodes, but given the limitations of existing information, mineral and bone disorders that would differ from guidelines
we did not propose measuring uric acid as a standard part of for the general population. The ERT identified a single study
evaluation or follow-up processes at this time. The risk of gout of fractures in kidney donors (moderate risk of bias, with only
after kidney donation may vary based on demographic charac- a single study the quality of evidence was deemed very low; Ev-
teristics. A study of 4650 kidney donors from the US including idence Report Table 8, SDC, http://links.lww.com/TP/B434;
13.1% African Americans, found that, by 7 years, African Supplemental Appendix Table D5 SDC, http://links.lww.com/
Americans were almost twice as likely to develop gout as white TP/B432). In this study, 2015 kidney donors in Ontario,
donors (4.4% vs 2.4%; adjusted HR, 1.01.83.2).204 Postdona- Canada, experienced no increase in the risk of non–trauma-
tion gout risk also increased with older age at donation and related upper- or lower-extremity fractures compared with
was nearly 3-times higher in men compared with women.204 healthy nondonors.210
In nondonor populations hyperuricemia is associated with What Prior Guidelines Recommend
a higher risk of CVD and new-onset CKD.203,205 However, As many of the studies on hyperuricemia, gout and min-
the prognostic significance of hyperuricemia in living kidney eral and bone disease in living kidney donors are recent, these
donors is currently uncertain and warrants additional study. issues have generally not been addressed in prior donor
In the US cohort study mentioned above, compared with guidelines. The British Transplantation Society describes the
matched donors without gout, donors with gout had more importance assessing a history of gout as part of the candi-
frequent diagnoses of acute kidney injury, CKD, and other date evaluation.48 Amsterdam Forum and Spanish Society
disorders of the kidney. of Nephrology and Spanish National Transplant Organisa-
Donor candidates and donors with prior episodes of gout tion guidelines describe serum uric acid as a standard test in
should be informed of recommended methods to reduce their the evaluation of all living kidney donor candidates.38,54
risk of future episodes of gout. Previous clinical practice
guidelines cite modest to low evidence for certain diet and
lifestyle measures (eg, avoiding excessive alcohol, and avoid- RESEARCH RECOMMENDATIONS
ing ingestion of organ meats high in purine content) and pos- • Determine the effects of hyperuricemia in living kidney donor
sibly pharmacological therapies.206 The prevention and candidates and donors on the incidence of gout and CVD.
treatment of hyperuricemia and gout may be complicated by • Perform long-term follow-up of donors and healthy
decreased kidney function. The dose of allopurinol, which is nondonor controls to determine the impact of kidney do-
frequently used to treat increased serum uric acid and prevent nation on gout recurrence.
gout, should be adjusted in patients with decreased kidney • Perform long-term follow-up of donors and healthy
function. Dose reductions may not be necessary with newer nondonor controls to determine the impact of kidney do-
uricosuric agents.207 Nonsteroidal anti-inflammatory drugs nation (if any) on fracture risk.
C.Agnello SE 0271
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 275 of 569 PageID S53
KDIGO Living Kidney Donor Work Group
#:
469
CHAPTER 10: PREDONATION BLOOD PRESSURE predonation BP on several occasions,212,213 and/or consider-
Except in the case of Recommendation 10.6, the ERT ation of ABPM in donor candidates with elevated office read-
search parameters did not identify evidence from eligible ings, receiving antihypertensive therapy, or who are older at
studies pertinent to the recommendations in chapter 10 and evaluation.38,50,51,196,214,215
therefore the following recommendations are “Not Graded.” Hypertension is defined by office readings of systolic SBP
of 140 mm Hg or greater or diastolic BP (DBP) of 90 mm
Evaluation Hg or greater, out-of-office daytime mean ABPM or home
10.1: Blood pressure should be measured before donation on measurements of SBP of 135 mm Hg or greater or DBP of
at least 2 occasions by clinical staff trained in accurate 85 mm Hg or greater,213 or the need for medication to con-
measurement technique, using equipment calibrated trol BP. Note that some antihypertensive agents may be used
for accuracy. for indications other than BP treatment (eg, diuretics for
10.2: When the presence or absence of hypertension in a do- edema or beta-blockers for migraine headache preven-
nor candidate is indeterminate based on history and tion), and that the indication for the prescribed medica-
clinic measurements (eg, blood pressure is high normal tions should be determined as part of the evaluation.
or variable), blood pressure should be further evalu- White coat hypertension is defined as hypertension by of-
ated using ambulatory blood pressure monitoring fice BP measurements with normal out of office measure-
(ABPM) or repeated using standardized blood pressure
ments by ABPM or home readings. Individuals with white
measurements.
coat hypertension have lower cardiovascular risk than per-
Selection sons with hypertension, but may carry increased risk for fu-
ture hypertension.212,216 Population-based studies suggest
10.3: Normal blood pressure, as defined by guidelines for the
that 20-25% of adults may have white coat hypertension.216
general population in the country or region where dona-
tion is planned, is acceptable for donation. Individuals with treated hypertension may also have a “white
10.4: Donor candidates with hypertension that can be con- coat effect,” such that elevated BP is recorded in the medical
trolled to systolic blood pressure less than 140 mm Hg environment even when treated BP is controlled by ABPM or
and diastolic blood pressure less than 90 mm Hg using home readings.
1 or 2 antihypertensive agents, who do not have evidence Masked hypertension is defined as normal BP by office
of target organ damage, may be acceptable for donation. measurements with hypertension by ABPM or home read-
The decision to approve donor candidates with hyperten- ings. Like sustained hypertension, masked hypertension is ac-
sion should be individualized based on demographic and companied by increased risk for hypertensive target organ
health profile in relation to the transplant program’s ac- damage, and thus treatment is warranted if identified.
ceptable risk threshold.
Population-based studies suggest that 10-30% of adults may
have masked hypertension.216,217 Masked hypertension can-
Counseling
not be identified in donor candidates in whom BP is measured
10.5: Donor candidates should be counseled on lifestyle inter- by office readings alone, but the implications of requiring
ventions to address modifiable risk factors for hyperten- ABPM or home readings to screen for masked hypertension
sion and cardiovascular disease, including healthy diet, in donor candidates (eg, outcomes, cost, efficiency) are not
smoking abstinence, achievement of healthy body weight, defined.
and regular exercise according to guidelines for the gen-
eral population. These measures should be initiated be-
fore donation and maintained lifelong. Hypertension Risk Factors and Counseling
10.6: We suggest that donor candidates should be informed
that blood pressure may rise with aging, and that dona- Potentially modifiable risk factors for hypertension include
tion may accelerate a rise in blood pressure and need for use of certain medications (eg, nonsteroidal anti-inflammatory
antihypertensive treatment over expectations with nor- agents, decongestants, stimulants) and presence of certain life-
mal aging. (2D) style factors (eg, excess alcohol intake, high sodium diet,
use of dietary supplements, or smoking).218-220 Nonmod-
RATIONALE ifiable hypertension risk factors include a family history of
hypertension, race, and age. Additional considerations in-
Evaluation and Definitions
clude women with a history of preeclampsia or gestational
BP Measurement and Classification hypertension. In this setting we suggest predonation counsel-
It is important to use an accurate, well-calibrated device ing on the potential for increased cardiovascular risk and em-
and an appropriately sized BP cuff based on arm length and phasis on healthy behaviors to reduce cardiovascular risk.
circumference. An overly small cuff will overestimate and Risk factors for hypertension by themselves do not constitute
an excessively large cuff will underestimate true BP levels. contraindications to donation in a normotensive person.
The donor candidate should be seated quietly with back sup- Consistent with recommendations for the general popula-
ported, feet on the floor and arm supported at heart level for tion,221 British Transplantation Society and Renal Associa-
the measurements. It is advisable to measure BP on at least tion guidelines48 recommend lifestyle measures in kidney
2 separate occasions by trained staff, or on one occasion plus donors to reduce the risk of hypertension and its conse-
ambulatory BP monitoring (ABPM) to minimize anxiety ef- quences, including frequent exercise, smoking cessation,
fects in donor candidates.211 Automated serial BP measure- and weight loss where appropriate.
ments can also eliminate a “white coat” effect.212 Multiple Target organ damage may be manifest as prior occurrence
prior guidelines and policies for the evaluation and care of of a cardiovascular event such as myocardial infarction or
living kidney donor candidates recommend assessment of stroke, urine AER greater than 30 mg/d (ACR > 30 mg/g or
C.Agnello SE 0272
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 276 of 569 PageID #:
S54 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S
470 www.transplantjournal.com
3 mg/mmol), reduced kidney function (eg, GFR < 60 mL/min Table D10, SDC, http://links.lww.com/TP/B432). Further-
per 1.73 m2), hypertensive retinopathy, and/or evidence of left more, many donors in this study were unaware of their hy-
ventricular hypertrophy.213 pertension. Associations of age at donation and sex with
Lifestyle modification can effectively treat hypertension postdonation hypertension have been inconsistent (Supple-
without medication or with fewer medications and lower mental Appendix Tables D7 and D9, SDC, http://links.lww.
dosages required to achieve BP control.221 Lifestyle modifica- com/TP/B432).
tions include healthy diet, smoking cessation, weight loss if Based on these data, we suggest that donor candidates should
overweight, regular exercise, and discontinuation of poten- be informed that BP may rise with aging, and that donation
tial contributing medications according to guidelines for the may accelerate the rise in BP and the need for antihypertensive
general population. Follow-up of patents with hypertension treatment over that expected with normal aging, especially if BP
is critical for monitoring of control in relation to targets is high-normal before donation and among African American
and for monitoring and management of complications. The donor candidates. Furthermore, antihypertensive medication is
importance of access to healthcare and regular follow-up more likely to be prescribed after donation.
have also been emphasized in the selection and care of hyper-
tensive donor candidates in 2 prior guidelines,38,54 whereas Hypertension as a Cause of CKD in the General
the Spanish Society of Nephrology and Spanish National
Population
Transplant Organisation guidelines specify “reasonable Hypertension is a contributing cause of CKD in the gen-
guarantee that the donor will follow the check-up period eral population, although in many cases, CKD may be the
and treatment indefinitely” among the criteria for acceptance cause of hypertension. A recent meta-analysis based on data
of a hypertensive donor candidate.54 from nearly 5 million healthy persons identified from 7 gen-
eral population cohorts found that every 20 mm Hg increase
Selection in SBP was associated with a 42% increase (adjusted HR,
Impact of Reduced GFR on BP in the General Population 1.271.421.58) in the risk of ESKD over median cohort
and After Donation follow-up of 4 to 16 years. Use of antihypertensive medica-
Reduced kidney function may cause or worsen hyperten- tions was also associated with increased ESKD risk (adjusted
sion in the general population.222 While it is documented that HR, 1.011.351.82 over cohort follow-up).7 After calibration to
BP often rises with aging,223 GFR reduction from kidney do- annual ESKD incidence in the US healthy population, varia-
nation may accelerate the risk or progression of hypertension tions in the projected 15-year and lifetime risks of ESKD
over time to a greater extent than expected from normal aging, based on level of SBP from this analysis were generated ac-
possibly due to physiological alterations (eg, hyperfiltration cording to age, sex, and race for healthy persons (assuming
in the remaining kidney, changes in vascular tone and renin- age-specific GFR, urine ACR 4 mg/g [0.4 mg/mmol], BMI
angiotensin-aldosterone regulation) and/or heightened de- 26 kg/m2, and absence of diabetes mellitus; (Figures 14 and
tection at donor follow-up.224,225 Existing retrospective 15). While these figures are useful for visualizing the impact
studies examining the impact of kidney donation on hyper- of higher SBP on increased ESKD risk, we endorse consider-
tension risk have been limited by short follow-up times, high ation of BP as part of the assessment of predicted long-term
rates of loss to follow-up, lack of controls and/or compari- ESKD risk based on a donor candidate’s complete demo-
sons to unselected general rather than healthy populations. graphic and health profile (as opposed to consideration of sin-
Use of antihypertensive medications was lower in a cohort gle risk factors in isolation).
of privately-insured donors compared with age- and sex- Clinical consequences of hypertension vary by race in the
matched unscreened beneficiaries in the same insurance general population. Treating mild-to-moderate primary hy-
plan.226 In contrast, a systematic review including data for pertension may not halt kidney disease progression in non-
5145 predominantly white donors estimated 6 mm Hg diabetic African Americans, whereas hypertension control
higher weighted mean SBP and 4 mm Hg higher weighted appears to slow kidney disease progression in European
mean DBP in donors compared with controls after an aver- Americans.230-234 Recent literature supports that at least a por-
age of 7 years224 (Supplemental Appendix Tables D1 and tion of kidney failure previously attributed to hypertensive
D2, SDC, http://links.lww.com/TP/B432). An administrative nephrosclerosis in persons of African descent may be genetically
claims linkage study of 1278 (primarily white race) living do- mediated by coding variants in the gene for APOL1 and not
nors in Ontario, Canada followed for a mean of 6 years modifiable by antihypertensive therapy (see chapter 14).235-238
(range, 1-16 years) found a higher incidence of claims-based
hypertension diagnoses (16.3% vs 11.9%; HR, 1.21.41.7) Predonation Hypertension as a Risk Factor for Adverse
among living donors compared with matched controls who Outcomes after Kidney Donation
were also screened for the absence of baseline comorbidities Living donor candidates undergo a rigorous evaluation
through administrative claims.225 process which includes measurement of kidney function
Among more recent donor cohorts, higher rates of post- and urine protein, but subtle scarring of the kidney from
donation hypertension and antihypertensive medication use hypertensive nephrosclerosis may not be detected by these
in African American compared with white donors have been tests.239 Compensatory hyperfiltration in the remaining kid-
reported.226-228 While these patterns parallel hypertension ney is normal after nephrectomy240,241; however, subclinical
prevalence differences in the general population,228 one small pathology or aging processes may impair compensation and
study found higher rates of postdonation hypertension reduce postdonation GFR.240,242
among 103 African American donors compared with race- The ERT identified 3 studies, rated as very low quality in
matched “healthy” nondonor controls (41% vs 18% at an reporting postdonation outcomes according to predonation
average of 6.8 years postdonation)229 (Supplemental Appendix BP or hypertension status (Evidence Report Table 19, SDC,
C.Agnello SE 0273
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 277 of 569 PageID S55
KDIGO Living Kidney Donor Work Group
#:
471
FIGURE 14. Estimated 15-year incidence (%) of ESKD in the United States according to baseline systolic blood pressure (SBP) and demo-
graphic profile from the CKD-PC. SBP mm Hg without (black) and with (red) antihypertension medication. *The base-case scenario is de-
fined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages 20, 30, 40, 50, 60, 70, and 80 years, respectively),
SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no diabetes mellitus or antihypertensive medication use. These were
selected as being representative of recent US living kidney donors where, with the exception of eGFR, there was little variation in health char-
acteristics by age. ACR, albumin-to-creatinine ratio; BMI, body mass index; CKD-PC, Chronic Kidney Disease-Prognosis Consortium, eGFR,
estimated glomerular filtration rate; ESKD, end-stage kidney disease. Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk
projection for the living kidney-donor candidate. N Engl J Med. 2016;374:411-421.7
http://links.lww.com/TP/B434, and Supplemental Appendix Norway, each 1 mm Hg increase in SBP was associated with a
Table D16, SDC, http://links.lww.com/TP/B432). In a com- small increase in cardiovascular death and ESKD during up to
bined cohort of donors and matched healthy nondonors in 25 years of follow-up.32 A study of only 6 hypertensive donors
FIGURE 15. Estimated lifetime incidence (%) of ESKD in the United States according to baseline systolic blood pressure (SBP) and demographic
profile from the CKD-PC. SBP mm Hg without (black) and with (red) antihypertension medication. *The base-case scenario is defined as:
age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages 20, 30, 40, 50, 60, 70, and 80 years, respectively), SBP
120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no diabetes mellitus or antihypertensive medication use. These were se-
lected as being representative of recent US living kidney donors where, with the exception of eGFR, there was little variation in health charac-
teristics by age. Lifetime risk projections are based on 15 years of follow-up data and calibrated to the incidence of ESKD in the low-risk
population, and thus are likely imprecise. ACR, albumin-to-creatinine ratio; BMI, body mass index; CKD-PC, Chronic Kidney Disease-Progno-
sis Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease. Reprinted from Grams ME, Sang Y, Levey AS, et al.
Kidney-failure risk projection for the living kidney-donor candidate. N Engl J Med. 2016;374:411-421.7
C.Agnello SE 0274
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 278 of 569 PageID #:
S56 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S
472 www.transplantjournal.com
reported CKD in 4 (67%) compared with 22% of non- there is limited evidence from the donor population to make
hypertensive donors during an average of 5.4 years follow- recommendations for donor acceptance based on hyperten-
up.243 A third study of 16 hypertensive donors was deemed sion status alone. Rather we endorse adherence to the general
at high risk of bias.244 A systematic review by Young et al framework that compares predicted individual long-term
concluded that results from this and 2 additional studies ESKD risk according to baseline profile of demographic
were substantially heterogeneous and thus results were not and health characteristics including BP to the transplant
pooled.26 program’s acceptable risk threshold.
Additional studies that did not meet criteria for the ERT
evidence review include a large study based on linkage of RESEARCH RECOMMENDATIONS
the US Transplant Registry with national death records that
found higher perioperative mortality among donors with ver- • Define optimal strategies for measuring BP during the donor
sus without predonation hypertension (36.7 vs 1.3 per candidate evaluation.
10 000).23 While reported baseline hypertension was not as- • Determine optimal strategies for treatment of hypertension in
sociated with long-term mortality, SBP of 140 mm Hg or kidney donor candidates before donation, and in accepted do-
nors after donation.
greater at donor registration was associated with 3-times
• Quantify the impact of living kidney donation on hyperten-
the adjusted RR of death over 12 years compared to SBP less sion risk, as well as the impact of hypertension before and af-
than 120 mm Hg (adjusted HR 1.13.39.7). A single-center ter donation on clinical outcomes including CVD and lifetime
study of 24 white, older (mean age, 53 years) donors with ESKD risk.
predonation hypertension (awake ABPM > 135/85 mm Hg • Evaluate possible variation in the risk and consequences of hy-
and clinic/nurse-measured BP > 140/90 mm Hg) that was pertension at donation according to other characteristics, in-
not included in the evidence review based on sample size cluding baseline demographic and other clinical factors.
found similar postdonation GFR reduction and urine protein
excretion as in normotensive donors, and no increase in uri-
nary protein excretion compared with predonation values CHAPTER 11: PREDONATION METABOLIC AND
over a mean 282 days of follow-up.245 A recent US registry LIFESTYLE RISK FACTORS
study found that ESKD among donors was more likely to The ERT search parameters did not identify evidence from
be attributed to hypertension if the duration of follow-up eligible studies pertinent to the recommendations in chapter
was more than 10 years compared with less than 10 years.31 11 and therefore the following recommendations are “Not
The WG concluded that the decision to approve donation Graded.”
in candidates with hypertension should be individualized
based on demographic and health profile in relation to the Identification of Metabolic and Lifestyle Risk Factors
transplant program’s acceptable risk threshold. Donor candi-
11.1: Risk factors for kidney and cardiovascular disease
dates with hypertension should be treated according to should be identified before donation and addressed
guidelines for the general population in the country or region by counseling to promote long-term health.
where donation will occur. BP control should be confirmed
by standardized BP measurements over at least several weeks Obesity
before donation. Donor candidates with hypertension should
11.2: Body mass index (BMI) should be computed based
be informed that donation may accelerate the rise in BP and
on weight and height measured before donation,
the need for antihypertensive treatment over expectations and classified based on World Health Organization
with normal aging, and that uncontrolled hypertension may (WHO) criteria for the general population or race-
cause target organ damage to their remaining kidney, and specific categories.
be counseled on the importance of maintaining a healthy life- 11.3: The decision to approve donor candidates with obesity
style and BP control before and after donation. and BMI >30 kg/m2 should be individualized based on
demographic and health profile in relation to the trans-
plant program’s acceptable risk threshold.
What Prior Guidelines Recommend 11.4: Donor candidates who have had bariatric surgery
Multiple prior guidelines for the evaluation and care of liv- should be assessed for risk of nephrolithiasis.
ing kidney donor candidates identify hypertensive end-organ
Glucose Intolerance
damage (eg, proteinuria, microalbuminuria, left ventri-
cular hypertrophy, and hypertensive retinopathy), as rela- 11.5: Donor candidates should be asked about prior diagno-
tive contraindications or exclusion criteria for kidney sis of diabetes mellitus, gestational diabetes, and family
donation.38,48,50,54,55,196,214,215 Other relative contraindi- history of diabetes.
cations or exclusion criteria for donation defined in prior 11.6: Glycemia should be assessed by fasting blood glucose
guidelines include uncontrolled hypertension48,55,196,214; and/or glycated hemoglobin (HbA1c) before donation.
need for more than 1,54 or more than 2 antihypertensive 11.7: 2-hour glucose tolerance testing or HbA1c testing
agents214,215 for adequate control; hypertension and age should be performed in donor candidates with elevated
fasting blood glucose, history of gestational diabetes,
younger than 50 years at evaluation196; non-white or
or family history of diabetes in a first-degree relative,
African American race54,196; or the presence of several co- and results should be used to classify diabetes or predi-
morbidities or cardiovascular risk factors.50,196,214 We con- abetes status using established criteria for the general
cur that uncontrolled hypertension or hypertension with population.
target organ damage should be exclusions to kidney donation. 11.8: Donor candidates with type 1 diabetes mellitus should
However, based on our evidence review, we also conclude that not donate.
C.Agnello SE 0275
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 279 of 569 PageID S57
KDIGO Living Kidney Donor Work Group
#:
473
11.9: The decision to approve donor candidates with predia- obesity may differ from WHO standards in non-whites,
betes or type 2 diabetes should be individualized based and race-specific thresholds have been proposed. Measure-
on demographic and health profile in relation to the ment of waist circumference and/or waist-to-hip ratios may
transplant program’s acceptable risk threshold. also be considered to characterize the distribution of adiposity
11.10: Donor candidates with prediabetes or type 2 diabetes
in obese persons.251
should be counseled that their condition may progress
over time and may lead to end-organ complications. Multiple prior guidelines and policies for the evaluation
and care of living donors recommend measurement of fasting
Dyslipidemias plasma glucose and consideration of oral glucose tolerance
testing and/or glycated hemoglobin (HbA1c) as part of the
11.11: Fasting lipid profile (including total cholesterol, LDL-C, donor evaluation.38,48,51,196,252 The WHO defines diabetes
HDL-C and triglycerides) should be measured as
mellitus as: fasting plasma glucose of 7.0 mmol/L or greater
part of an overall cardiovascular risk assessment be-
fore donation. (≥126 mg/dL), random plasma glucose of 11.1 mmol/L or
11.12: The decision to approve donor candidates with dyslip- greater (≥200 mg/dL), or plasma glucose concentration of
idemia should be individualized based on demographic 11.1 mmol/L or greater (≥200 mg/dL) 2 hours after a 75-g
and health profile in relation to the transplant pro- anhydrous glucose load in an oral glucose tolerance test.
gram’s acceptable risk threshold. A 2011 addendum included recognition of HbA1c of
48 mmol/mol or greater (6.5%) as an additional criterion
Tobacco Use for diagnosing diabetes if assays are standardized to criteria
11.13: The use of tobacco products should be assessed before aligned with international reference values, but also indi-
donation. cated that HbA1c less than 48 mmol/mol (6.5%) does not ex-
11.14: Donor candidates who use tobacco products should be clude diabetes diagnosed using glucose tests.246
counseled on the risks of perioperative complications, The WHO defines Impaired Glucose Tolerance as fasting
cancer, cardio-pulmonary disease and kidney failure, plasma glucose less than 7.0 mmol/L (<126 mg/dL) or
should be advised to abstain from use of tobacco prod- 2-hour post–load plasma glucose of 7.8 or greater and less
ucts, and should be referred to a tobacco cessation sup- than 11.1 mmol/L (≥140 and < 200 mg/dL), while Impaired
port program if possible. Fasting Glucose is defined as fasting plasma glucose 6.1 to
11.15: The decision to approve donor candidates who are ac-
6.9 mmol/L (110 to 125 mg/dL) or 2-hour post–load plasma
tive tobacco users should be individualized based on
demographic and health profile in relation to the trans- glucose less than 7.8 mmol (<140 mg/dL).253 Currently there
plant program’s acceptable risk threshold. are various definitions of prediabetes and the equivalent term
used by WHO, intermediate hyperglycemia, is defined by
RATIONALE fasting plasma glucose of 6.1 to 6.9 mmol/L (110-125 mg/dL)
and 1-hour post–load plasma glucose of 7.8-11.0 mmol/L
Goals of Evaluation and Definitions (140-199 mg/dL).254
This section addresses the evaluation and management of Dyslipidemias are classified based on elevations in total cho-
metabolic and lifestyle risk factors associated with ESKD, lesterol and low-density lipoprotein cholesterol (LDL-C), and
CVD and/or all-cause mortality, as applicable to the care of low concentrations of high-density lipoprotein cholesterol
donor candidates. Some of the factors considered do not have (HDL-C). Hypertriglyceridemia is an independent CVD risk
currently known associations with ESKD risk, but are rele- factor.255
vant to a comprehensive predonation health assessment.
Even if donation does not increase the risk, traditional Obesity
CVD risk factors are expected to have at least the same effect Increased risk of perioperative complications including
in donors as in the general population. Attention to these risk wound and surgical site infections in obese patients is well es-
factors is intended to prevent or delay the onset and progres- tablished in the general surgical literature.256 The ERT report
sion of comorbid diseases, kidney disease, and CVD. All risk identified 2 systematic reviews that examined perioperative
factors considered in this section are potentially modifiable outcomes after donor nephrectomy according to BMI, with
by lifestyle and/or medical care. quality of source studies rated as low. Among 8 studies
According to World Health Organization (WHO), the pre- reporting operative time, all but one found a modest increase
valence of diabetes mellitus increased from 108 million people in operative time (mean difference of 16.9 minutes) among
worldwide in 1980 to 422 million in 2014.246 The rising prev- donors with BMI of 30 or greater compared to those with
alence of diabetes is linked with the obesity epidemic and 2.1 BMI less than 30 kg/m2 (Supplemental Appendix Table C7,
billion adults worldwide were estimated to be overweight or SDC, http://links.lww.com/TP/B432). While warm ischemia
obese in 2013.247 Underlying causes of the obesity epidemic times were reported to be longer for obese donors in all but
may be modifiable, and include sedentary lifestyles, high-fat one study, this difference was not significant on meta-analysis.
and energy-dense diets, and increased urbanization.248-250 Pooled results showed no differences in blood loss or length
The WHO defines obesity based on thresholds of BMI, of stay among obese compared with normal weight donors.
a measure of weight scaled for height, as: underweight In the general population, obesity has been identified as a
(<18.5 kg/m2), normal weight (18.5-24.9 kg/m2), overweight risk factor for diabetes mellitus and it may also be a risk fac-
(25-29.9 kg/m2), obese (30-34.9 kg/m2), and morbidly obese tor for kidney disease, particularly obesity-related glomeru-
(>35 kg/m2).248 While BMI is recognized to be an imperfect lopathy.257 The ERT identified 5 studies comparing long-
measure of body composition, the components of BMI are term outcomes among donors by predonation BMI, rated
easily measured, recorded, and followed over time, and have as low quality, with follow-up ranging from 6.7 to 15.1 years
prognostic implications. Optimal BMI-based thresholds for (Supplemental Appendix Table D12, SDC, http://links.lww.
C.Agnello SE 0276
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 280 of 569 PageID #:
S58 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 474 www.transplantjournal.com
com/TP/B432). One study found that BMI was associated systemic review found a stronger association of higher BMI at
with cardiovascular mortality but not all-cause mortal- donation with postdonation ESKD risk over 20 years than the
ity.32 In contrast, another registry study found no associa- predonation risk relationship observed in the general population
tion between BMI and death over 12 years.23 A few studies cohorts.260 We endorse consideration of BMI as part of the
of variable quality examined associations between BMI assessment of predicted long-term risk based on a donor
and intermediate outcomes.140,244,258 candidate’s complete demographic and health profile (as
Multiple prior guidelines for the evaluation and care of liv- opposed to consideration of single risk factors in isolation).
ing kidney donor candidates recommend BMI greater than Findings from the recent US study260 suggests more uncer-
35 kg/m2 as an absolute or relative contraindication to dona- tainty when drawing inferences about long-term postdonation
tion.38,48,50,54,196,215,259 and other guidelines recommend risk in obese donor candidates, and the need to develop indi-
careful evaluation for other comorbidities in donor candi- vidualized postdonation risk estimates according to demo-
dates with BMI greater than 30 kg/m2.48,54 With regard to graphic and health profile. Acceptance thresholds for donor
other metrics of obesity aside from BMI, the Spanish Society candidate BMI can incorporate perinephrectomy complications
of Nephrology and Spanish National Transplant Organisa- along with long-term risks of ESKD and other complications as
tion guidelines define waistline greater than 82 cm in women data become available.
or greater than 102 cm in men as additional relative contra- We agree with prior recommendations that obese donor
indications to donation.54 CARI guidelines advise mea- candidate should be counseled about the long-term risks of
surement of waist circumference within the assessment of obesity, advised to pursue weight loss before donation, and
overweight and obese donor candidates,259 and a US Joint to maintain a healthy body weight after donation.38,48,50,215
Societies work group consensus statement includes abdomi-
nal circumference as part of the definition of metabolic syn- Glucose Intolerance
drome.196 In contrast, the ERT concluded that there is Type 2 diabetes is a leading cause of CKD worldwide and
limited evidence from the donor population to make recom- accounts for approximately 50% of acquired, adult-onset
mendations for donor acceptance based on BMI alone ESKD.261,262 Patients with diabetes mellitus are commonly
among obese donor candidates. excluded from living kidney donation. One report of 71 do-
A recent meta-analysis based on data from nearly 5 million nors with baseline glucose intolerance including 27 older pa-
healthy persons identified from 7 general population cohorts tients (mean age, 58 years) with diabetes defined by 2-hour
found a modest association of BMI greater than 30 kg/m2 glucose tolerance testing found no ESKD events and similar
with increased risk of ESKD over median cohort follow-up survival compared to donors without glucose intolerance
of 4 to 16 years (adjusted HR, 1.041.161.29).7 Projected over a mean follow-up of 88 months (Supplemental Appen-
15-year and lifetime risks of ESKD for healthy persons varied dix Table D14, SDC, http://links.lww.com/TP/B432).263
according to BMI and age, sex, and race (Figures 16 and 17). A recent meta-analysis based on data from nearly 5 million
A recent study of 119 769 US donors published after the ERT persons identified from 7 general population cohorts found
FIGURE 16. Estimated 15-year incidence (%) of ESKD in the United States according to baseline body mass index (BMI) and demographic pro-
file from the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages 20,
30, 40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no diabetes mellitus or an-
tihypertensive medication use. These were selected as being representative of recent US living kidney donors where, with the exception of eGFR, there
was little variation in health characteristics by age. ACR, albumin-to-creatinine ratio; CKD-PC, Chronic Kidney Disease-Prognosis Consortium, eGFR,
estimated glomerular filtration rate; ESKD, end-stage kidney disease; SBP, systolic blood pressure. Reprinted from Grams ME, Sang Y, Levey
AS, et al. Kidney-failure risk projection for the living kidney-donor candidate. N Engl J Med. 2016;374:411-421.7
C.Agnello SE 0277
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 281 of 569 PageID S59
KDIGO Living Kidney Donor Work Group
#:
475
FIGURE 17. Estimated lifetime incidence (%) of ESKD in the United States according to baseline body mass index (BMI) and demographic profile
from the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages 20,
30, 40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no diabetes mellitus or
antihypertensive medication use. These were selected as being representative of recent US living kidney donors where, with the exception of
eGFR, there was little variation in health characteristics by age. Lifetime risk projections are based on 15 years of follow-up data and calibrated
to the incidence of ESKD in the low-risk population, and thus are likely imprecise. ACR, albumin-to-creatinine ratio; CKD-PC, Chronic Kidney
Disease-Prognosis Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; SBP, systolic blood pressure.
Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor candidate. N Engl J Med.
2016;374:411-421.7
that, compared with nondiabetic persons, those with type (adjusted HR, 1.913.014.74).7 The 15-year and lifetime risks
2 diabetes but otherwise good health had 3-times the risk of of ESKD for healthy persons varied by type 2 diabetes and
ESKD over median cohort follow-up of 4 to 16 years age, sex, and race (Figures 18 and 19). Multiple prior
FIGURE 18. Estimated 15-year incidence (%) of ESKD in the United States according to non–insulin-dependent diabetes mellitus status and
demographic profile from the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min
per 1.73 m2 for ages 20, 30, 40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2,
and no diabetes mellitus or antihypertensive medication use. These were selected as being representative of recent US living kidney donors
where, with the exception of eGFR, there was little variation in health characteristics by age. ACR, albumin-to-creatinine ratio; BMI, body mass
index; CKD-PC, Chronic Kidney Disease-Prognosis Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease;
SBP, systolic blood pressure. Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor can-
didate. N Engl J Med. 2016;374:411-421.7
C.Agnello SE 0278
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 282 of 569 PageID #:
S60 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 476 www.transplantjournal.com
FIGURE 19. Estimated lifetime incidence (%) of ESKD in the United States according to non–insulin-dependent diabetes mellitus status and
demographic profile from the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per
1.73 m2 for ages 20, 30, 40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no
diabetes mellitus or antihypertensive medication use. These were selected as being representative of recent US living kidney donors where,
with the exception of eGFR, there was little variation in health characteristics by age. Lifetime risk projections are based on 15 years of follow-up
data and calibrated to the incidence of ESKD in the low-risk population, and thus are likely imprecise. ACR, albumin-to-creatinine ratio; BMI, body
mass index; CKD-PC, Chronic Kidney Disease-Prognosis Consortium, eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney dis-
ease; SBP, systolic blood pressure. Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney-donor
candidate. N Engl J Med. 2016;374:411-421.7
guidelines for the evaluation and care of kidney donors A small cohort study found that carefully screened predia-
recommend that diabetic persons be excluded from kidney betic living kidney donors may revert to normal fasting glucose
donation.38,54,179,196,215,252 However, the European Best and did not have an increased risk of impaired kidney function
Practice Guideline qualifies an exception of “exceptional in the short term267 (Evidence Report Table 17, SDC, http://
circumstances”215 and the British Transplantation Society links.lww.com/TP/B434; Supplemental Appendix Table D14,
recommends that “diabetics can be considered for kidney SDC, http://links.lww.com/TP/B432). However, quality of this
donation after a thorough assessment of the lifetime risk of study was very low. A recent study linking US national donor
cardiovascular and progressive renal disease in the presence registry data to ESKD registry data for 125 427 living donors
of a single kidney.”48 The WG concluded that persons with examined causes of ESKD after donation.31 The finding that
type 1 diabetes should be excluded from kidney donation. early postdonation ESKD was predominantly reported as due
However, consistent with the framework of integrated to glomerulonephritis while late postdonation ESKD was more
risk assessment, we endorse individualizing the decision frequently reported as diabetic-ESKD and hypertensive-ESKD
to approve donation in persons with prediabetes or type 2 could be consistent with an effect of donation on diabetes and
diabetes based on the severity of illness and predicted long- hypertension as causes for ESKD. These findings emphasize
term risk (considering complete demographic and health the importance of counseling donor candidates with prediabetes
profile) in relation to the transplant program’s acceptable regarding their increased lifetime risk for progression to diabetes
risk threshold. The WG considers that older candidates with and subsequent end-organ complications, and the importance
type 2 diabetes with well-controlled glycemia, not requiring of healthy lifestyle behaviors to reduce risks. Those who are ap-
insulin and without end-organ damage, might be considered proved to donate should be counseled on the importance of reg-
for donation. ular medical follow-up after donation including surveillance for
Prediabetes represents an intermediate category of hyper- hyperglycemia and kidney function for many decades after do-
glycemia, which poses increased risks for future type 2 diabe- nation, and prompt institution of appropriate management.
tes mellitus and CVD.261 Important risk factors for diabetes Prior recommendations regarding candidacy of persons with
and prediabetes in the general population include increasing prediabetes for kidney donation are conflicting. The European
age, high-risk ethnicity or race, obesity, and history of diabe- Best Practice Guideline states that impaired glucose tolerance
tes in a first degree relative. Approximately 5-10% of individ- is not an absolute contraindication to donation50,215; other
uals with prediabetes progress to diabetes per year264 but the guidelines consider prediabetes a relative contraindication54,196
risk of progression can be reduced with lifestyle changes and or a condition warranting careful consideration,48 while CARI
weight loss.265 The younger the individual with risk factors considers prediabetes as well as past history of gestational di-
for prediabetes, the higher the likelihood that diabetes and abetes to be absolute contraindications.252 Given the lack of
subsequent kidney disease will develop in that person’s re- current data specific to the donor population, we endorse in-
maining lifetime.266 dividualizing the decision to approve donation in persons with
C.Agnello SE 0279
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 283 of 569 PageID S61
KDIGO Living Kidney Donor Work Group
#:
477
prediabetes based on their predicted long-term risk in relation Tobacco Use
to the transplant program’s acceptable risk threshold. Cigarette smoking is a strong, modifiable risk factor for
CVD (as well as other adverse health outcomes such as lung
Dyslipidemias disease and cancer); smoking may also cause direct renal
Dyslipidemia is a modifiable risk factor for CVD, and damage through microvascular injury and promotion of ath-
hypertriglyceridemia and low HDL-C are components of erosclerosis, and has been associated with CKD in the general
the metabolic syndrome. With regard to associations of lipid population.268,269 A recent meta-analysis based on data from
levels with outcomes after donation, one study identified by nearly 5 million persons identified from 7 general population
the ERT compared kidney function and albuminuria at 5 years cohorts found that, compared with nonsmokers over median
among donors with versus without predonation metabolic cohort follow-up of 4 to 16 years, current smokers had a
syndrome (Evidence Report Table 18, SDC, http://links. 76% increase in the risk of ESKD (adjusted HR, 1.291.762.41)
lww.com/TP/B434; Supplemental Appendix Table D15, and past smokers had a 45% increase in risk (adjusted
SDC, http://links.lww.com/TP/B432). Although small differ- HR, 1.231.451.71).7 After calibration to annual ESKD inci-
ences in the outcomes were suggested, statistical comparisons dence in the US healthy population, variations in the
were not performed. No studies were identified comparing projected 15-year and lifetime risks of ESKD based on
postdonation outcomes based on lipid status alone. A recent smoking status were generated according to age, sex, and
meta-analysis based on data from nearly 5 million persons race for healthy persons (assuming age-specific GFR, urine
identified from 7 general population cohorts found no asso- ACR 4 mg/g [0.4 mg/mmol], SBP 120 mmHg, BMI 26 kg/m2,
ciations of total cholesterol or LDL-C with ESKD risk over and absence of diabetes mellitus; Figures 20 and 21).
median cohort follow-up of 4 to 16 years.7 Although data on the outcomes associated with smoking
Several prior guidelines recommend fasting lipid profiling as among living kidney donors are limited, an analysis of
part of the donor evaluation,51,54,59,196 but do not define donor linked US transplant registry and national death records
selection criteria based on lipid levels alone. A US Joint Societies found that while smoking was not significantly associated
work group consensus statement recognizes hypertriglyc- with perinephrectomy mortality, donors who smoked had
eridemia and low HDL-C as components of the metabolic syn- approximately 5-times the adjusted mortality over 12 years
drome, and considers impaired fasting glucose and other compared with nonsmoking donors.23 See chapter 4 (Preop-
components of metabolic syndrome to be relative contraindica- erative Evaluation) for a discussion of the smoking-related
tions to donation in persons younger than age 50 years.196 We risks before general surgery.
endorse individualizing the decision to approve donation in Some prior guidelines for the evaluation and care of living
persons with dyslipidemia based on their predicted long-term donors advise assessment of smoking, but make no recom-
risk (considering complete demographic and health profile) in mendations concerning smoking in the selection of do-
relation to the transplant program’s acceptance threshold. nors.51,196 Others advise encouraging smoking cessation
FIGURE 20. Estimated 15-year incidence (%) of ESKD in the United States according to baseline smoking status and demographic profile
from the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages
20, 30, 40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI, 26 kg/m2; and no diabetes
mellitus or antihypertensive medication use. These were selected as being representative of recent US living kidney donors where, with the ex-
ception of eGFR, there was little variation in health characteristics by age. Smoking status, current (Cur), former (For), and Never (Nev). ACR,
albumin-to-creatinine ratio; BMI, body mass index; CKD-PC, Chronic Kidney Disease-Prognosis Consortium, eGFR, estimated glomerular fil-
tration rate; ESKD, end-stage kidney disease; SBP, systolic blood pressure. Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-failure
risk projection for the living kidney-donor candidate. N Engl J Med. 2016;374:411-421.7
C.Agnello SE 0280
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 284 of 569 PageID #:
S62 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 478 www.transplantjournal.com
FIGURE 21. Estimated lifetime incidence (%) of ESKD in the United States according to baseline smoking status and demographic profile from
the CKD-PC. *The base-case scenario is defined as: age-specific eGFR (114, 106, 98, 90, 82, 74, and 66 mL/min per 1.73 m2 for ages 20, 30,
40, 50, 60, 70, and 80 years, respectively), SBP 120 mm Hg, urine ACR 4 mg/g [0.4 mg/mmol], BMI 26 kg/m2, and no diabetes mellitus or
antihypertensive medication use. These were selected as being representative of recent US living kidney donors where, with the exception of
eGFR, there was little variation in health characteristics by age. Lifetime risk projections are based on 15 years of follow-up data and calibrated to
the incidence of ESKD in the low-risk population, and thus are likely imprecise. Smoking status, current (Cur), former (For), and Never (Nev).
ACR, albumin-to-creatinine ratio; BMI, body mass index; CKD-PC, Chronic Kidney Disease-Prognosis Consortium, eGFR, estimated glomer-
ular filtration rate; ESKD, end-stage kidney disease; SBP, systolic blood pressure. Reprinted from Grams ME, Sang Y, Levey AS, et al. Kidney-
failure risk projection for the living kidney-donor candidate. N Engl J Med. 2016;374:411-421.7
without defining an exclusion criterion.48,50,215 Two guide- Study [HUNT] I).32 Mortality was similar in donors versus
lines recommend smoking cessation 4 weeks before do- nondonors over the first 15 years, but at 25 years after dona-
nor nephrectomy,38,54 and guidelines from the Spanish tion, cumulative all-cause mortality was approximately 18%
Society of Nephrology and Spanish National Transplant among donors versus 13% among healthy nondonors (ad-
Organisation emphasize long-term abstinence.54 The justed HR 1.11.31.5). Limitations of this study include differ-
2000 National Kidney Foundation (NKF)/AST guidelines rec- ences in accrual periods and in baseline characteristics
ommend considering acceptance of donor candidates who (including age) between the donors and nondonors.271,272
smoke only if they abstain form use of tobacco products for Continued study is needed to assess the impact of donation
6 months and have normal pulmonary studies.18 We endorse on long-term survival in large, representative cohorts.
individualizing the decision to approve donation in active Limited data are available on the impact of donation on
smokers based on their predicted long-term risk (considering the pathophysiology of CVD. The Chronic Renal Impair-
complete demographic and health profile) in relation to the ment in Birmingham (CRIB)-Donor study included 68 do-
transplant program’s acceptance threshold. nors at 2 United Kingdom centers (2011 to 2014), of whom
90% were white, and prospectively examined changes in left
Impact of Donation on Cardiac Risk ventricular mass and other CVD surrogate markers at
The ERT identified 2 studies comparing cardiovascular 12 months postdonation versus predonation, compared with
events in donors versus healthy nondonors (very low quality changes in these parameters in healthy nondonors.202 Donors
of evidence; Evidence Report Table 8, SDC, http://links.lww. had a greater increase in left ventricular mass (+7 ± 10 vs
com/TP/B434; Supplemental Appendix Table D5, SDC, −3 ± 8 g; P < 0.001) and mass:volume ratio (+0.06 ± 0.12 vs
http://links.lww.com/TP/B432). In a study comparing 2028 −0.01 ± 0.09 g/mL; P < 0.01), but decreased aortic distensiblity;
living kidney donors in Ontario, Canada (1992 to 2009) with donors were also more likely than controls to develop detect-
20 280 healthy, demographically matched nondonors, the risk able highly sensitive troponin T levels. The increase in left ven-
of death or major cardiovascular events over a median 7 years tricular mass among donors was independently associated
follow-up (maximum, 18 years) was lower in donors than in with the magnitude of decrease in mGFR. These pilot obser-
healthy nondonors (2.8 vs 4.1 events per 1000 person-years, vations warrant replication efforts in larger cohorts with lon-
adjusted HR, 0.480.660.90).270 The risk of death-censored ma- ger follow-up to better define the impacts of donation on
jor cardiovascular events was similar among donors and CVD surrogates and clinical events.
nondonors (1.7 vs 2.0 events per 1000 person-years).
A study with longer follow-up compared cardiovascular
RESEARCH RECOMMENDATIONS
and all-cause mortality in 1901 kidney donors with a group
of 32 621 healthy, matched controls selected from a • Evaluate the outcomes of donors with metabolic and lifestyle
population-based survey in Norway (Nord-Trøndelag Health risk factors for CVD, including perinephrectomy complications,
C.Agnello SE 0281
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 285 of 569 PageID S63
KDIGO Living Kidney Donor Work Group
#:
479
long-term mortality, CVD events, CKD/proteinuria and ESKD. as close in time to donation as possible. For HIV,
Develop integrated risk assessment tools tailored for demo- HBV and HCV, screening should be current within
graphic and health profiles. 28 days of donation.
• Quantify the direct effects of donation on CVD risk.
• Assess effectiveness of predonation interventions including Selection
counseling and weight or lifestyle changes on long-term donor 12.7: If a donor candidate is found to have a potentially
outcomes. transmissible infection, then the donor candidate,
• Assess the impact of the duration and durability of predonation intended recipient and transplant program team
weight loss on donor acceptance and postdonation outcomes in should weigh the risks and benefits of proceeding
those who proceed to donation. with donation.
CHAPTER 12: PREVENTING INFECTION
TRANSMISSION RATIONALE
The ERT search parameters did not identify evidence from Goals of Evaluation and Definitions
eligible studies pertinent to the recommendations in chapter The goals of infection screening in donor candidates are
12 and therefore the following recommendations are “Not to identify illnesses that may affect the donor candidate or
Graded.” the intended recipient.273-276 Evaluation of donor candi-
Evaluation dates to reduce the risk of transmissible infections should
include assessment of the individual’s history of past infec-
12.1: Risk for human immunodeficiency virus (HIV), hepati- tions and infectious disease risk factors (eg, risk of local en-
tis B virus (HBV), and hepatitis C virus (HCV) infec- demic infections or travel to endemic areas), awareness of
tions should be assessed before donation. current patterns of geographically endemic infections, and
12.2: Donor candidates should be assessed for factors as- focused microbiological screening.
sociated with an increased likelihood of endemic or un- Donor-derived infections can be classified as “expected”
expected infections, including geographic, seasonal, versus “unexpected.”274,276 The risks of “expected”
occupational, animal and environmental exposures. donor-derived infection transmission are defined by donor
12.3: Donor candidates should complete a urinalysis and and recipient screening, such as in high-risk scenarios for
testing for HIV, HBV, HCV, cytomegalovirus (CMV),
transmission of cytomegalovirus (CMV), Epstein-Barr virus
Epstein-Barr virus (EBV), and Treponema pallidum
(EBV) or toxoplasmosis from a seropositive donor to a sero-
(syphilis).
12.4: If indicated by regional epidemiology or individual negative recipient. “Expected” transmissions occur frequently
history, donor candidates should complete testing and are managed by surveillance and/or prophylaxis strategies
for Mycobacterium tuberculosis, Strongyloides, in the recipient after transplantation.277-282 “Unexpected”
Trypanosoma cruzi, West Nile virus, Histoplasmo- donor-derived infections arise despite routine donor screen-
sis, and/or Coccidiomycosis. ing, such as human immunodeficiency virus (HIV) or hepati-
12.5: Transplant programs should develop protocols to tis C virus (HCV) transmission due to false negative serologic
screen donor candidates for emerging infections testing or infection in a “window period.” The 2013 US Public
in consultation with local public health specialists. Health Service (PHS) Guideline provides an evidence-based ins-
12.6: In general, donor infection risk factor and microbio- trument to screen for behavioral factors associated with recent
logical assessments should be performed or updated HIV, hepatitis B virus (HBV), or HCV infection (Table 16).71
TABLE 16.
US Public Health Service (PHS) 2013 Screening for factors associated with increased likelihood of recent HIV, HBV, or HCV infection
• Donors who meet one or more of the following criteria should be identified as being at increased risk for recent HIV, HBV, and HCV infections.
• Each factor listed reflects increased risk of all 3 pathogens as an aggregate, as there is overlap of associated risk, even though each factor does not convey
risk from all pathogens equally.
• The first 6 factors address sexual contact; the definition of “had sex” refers to any method of sexual contact, including vaginal, anal and oral contact.
1. Have you had sex with a person known or suspected to have HIV, HBV, or HCV infections in the preceding 12 mo?
2. If male: Have you had sex with another man in the preceding 12 mo?
3. If female: Have you had sex with a man with a history of male-sex-with-male behavior in the preceding 12 mo?
4. Have you had sex in exchange for money or drugs in the preceding 12 mo?
5. Have you had sex with a person that has injected drugs (by intravenous, intramuscular, or subcutaneous route) for nonmedical reasons in the preceding
12 mo?
6. Have you injected drugs (by intravenous, intramuscular, or subcutaneous route) for nonmedical reasons in the preceding 12 mo?
7. Have you been in lockup, jail, prison, or a juvenile correctional facility for more than 72 h in the preceding 12 mo?
8. Have you been newly diagnosed with or have been treated for syphilis, gonorrhea, Chlamydia, or genital ulcers in the preceding 12 mo?
• Donors who meet the following criterion should be identified as being at increased risk for recent HCV infection only:
9. Have you been on hemodialysis in the preceding 12 mo?
US PHS risk factors also include: 10. A child who is ≤ 18 months of age and born to a mother known to be infected with, or at increased risk for HIV, HBV, or HCV infection. 11. A child who has been breastfed
within the preceding 12 months and the mother is known to be infected with, or at increased risk for, HIV infection. HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; PHS, Public
Health Service. Adapted with permission from Seem DL, Lee I, Umscheid CA, et al. Excerpt from PHS guideline for reducing HIV, HBV and HCV transmission through organ transplantation. Am J Transplant.
2013;13:1953–1962.71
C.Agnello SE 0282
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 286 of 569 PageID #:
S64 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S480 www.transplantjournal.com
“Unexpected” infectious disease transmissions through organ antiviral HBV treatment of the recipient and posttransplant
transplantation are rare, but may result in serious morbidity and monitoring. Kidney transplant recipients from anti-HBcAb
mortality.274,283 Although most “unexpected” disease trans- +/HBsAg-/HBV DNA- donors appear to have little risk of ac-
missions have involved deceased donors, cases of HIV and quiring active HBV infection.275,292 HBV NAT testing
HCV transmissions from living donors have been re- should be performed in donor candidates with isolated
ported.283,284 Notably, while reporting of suspected or docu- HBcAb+ status to further define risk of transmission. If the
mented donor-derived infection transmissions is required in donor is anti-HBc + and HBV DNA-, the risk of transmission
the United States, reporting is voluntary in many other coun- is negligible,293 especially if the recipient is anti-HBsAb + or
tries, and thus true incidence may be underestimated. has been effectively immunized against HBV. Still, the recipient
Infection transmission events may also be categorized ac- should be informed of the small potential risk of disease trans-
cording to the certainty that the donor is the origin of the in- mission, and posttransplant monitoring should be performed.
fection, as opposed to reactivation or de novo infection in the
recipient.285 Consensus-based definitions have been offered Hepatitis C Virus
to standardize categorization as: “proven,” “probable,” Evaluation of donor candidates should include US PHS
“possible,” “unlikely,” “excluded,” “intervened upon with- risk factor screening for increased risk of HCV infection.71
out documented transmission,” and “positive assay without Additional HCV risk factors identified by the US Centers
apparent disease transmission” events.285 “Proven” denotes for Disease Control for the general public (not specific to or-
clear evidence of the same infectious disease in the donor gan donation) include: persistently abnormal alanine amino-
and at least one of the recipients, while “probable” is based transferase concentrations, receipt of blood transfusion or
on strong evidence suggesting but not proving a disease trans- blood components before 1992, receipt of clotting factor
mission. Use of standardized nomenclature may facilitate concentrates produced before 1987, recognized exposure
global tracking and study of such infectious disease transmis- among healthcare workers, and children born from HCV+
sions as well as the comparison of data between published mothers.294 Regardless of past risk factors, all donor candi-
studies and reports collected globally.285 dates should undergo testing for HCV infection as close as
The risk of donor-derived disease transmission can be mit- possible to the date of the organ recovery, but within no
igated by the donor evaluation, including history taking (clin- longer than 28 days before donation.71 Thus, behavioral risk
ical, social/behavioral, travel) and microbiological testing. factor assessment is used to inform pretest probability for in-
While microbiological testing should be performed in all do- terpretation of microbiological test results and to guide
nors for some pathogens [HIV, HBV, HCV, CMV, EBV, syph- counseling to avoid infection after testing, not to determine
ilis], focusing testing for other pathogens based on regional which donor candidates should be tested. Approximately
epidemiology and individual clinical, social or geographic 15% of people with anti-HCV antibodies will not have de-
risk factors should reduce the likelihood of procuring an tectable HCV-RNA in the serum. The 2013 US PHS guideline
organ that could transmit infection, while preserving op- recommends that all living donor candidates should be tested
portunities for donation (avoiding false-positive test results) for both anti-HCV antibody and for HCV RNA by NAT.71
(Table 17). Approaches to screening should consider the Before the advent of new direct-acting antiviral agents, ac-
virulence of a particular pathogen, available testing assays, tive HCV infection in a donor candidate was considered a
and residual window periods for transmission despite contraindication to living donation, not only because of the
screening283,286 as discussed according to specific patho- risk of transmitting HCV to the recipient but also because
gen below.71,273,275,276,286-291 Risks versus benefit must be of the risk of glomerular disease in the donor.295 HCV has
balanced in the decision to use organs from infected donors, been transmitted to naïve organ recipients from infected liv-
incorporating predonation treatment and recipient prophy- ing and deceased donors.296 Organ transplantation from an
laxis where appropriate. It is also necessary to inform the re- HCV+ donor is associated with significant risk of HCV
cipient and their care team of any known risks from the transmission, especially to HCV- recipients.297 However,
potential donated kidney. how to handle the situation when an otherwise suitable living
kidney donor is HCV+ may evolve in the era of effective
Hepatitis B Virus treatment with direct-acting antiviral agents. It is of course
Evaluation of donor candidates should include US PHS best to use a living donor who is not HCV+. However, if
risk factor screening for increased risk of HBV infection.71 research protocols are developed to assess living kidney do-
All donor candidates should undergo testing for IgG hepatitis nation from HCV+ persons, then regardless of the HCV sta-
B core antibody (anti-HBcAb) and hepatitis B surface antigen tus of the recipient it would make sense that protocols require
(HBsAg).71,273,275 HBV DNA nucleic acid testing (NAT) can donor treatment with direct-antiviral agents for at least
further stratify transmission risk in donor candidates from 12 weeks, the treatment duration when most studies show
HBV endemic areas who are anti-HBcAb+, those with possi- sustained virologic response, before donating a kidney.298
ble mutant HBV infections, and those with abnormal liver
function tests or a past history of liver disease of unknown Human Immunodeficiency Virus
etiology. Testing for HBV should be performed as close as Evaluation of donor candidates should include US PHS
possible to the date of the organ recovery, but within no risk factor screening for increased risk of HIV infection.71
longer than 28 days before donation.71 All donor candidates should undergo microbiological testing
Transplantation of kidneys from HBsAg+ donors is con- for HIV infection as close as possible to the date of the organ
traindicated for HBV- recipients, but may be considered recovery, but within no longer than 28 days before dona-
for HBsAg+ recipients or recipients with HBV protective tion.71,275 HIV infection is a contraindication to organ dona-
immunity,275 with informed consent of the recipient, possible tion to HIV- recipients as the transmission of HIV by organ
C.Agnello SE 0283
TABLE 17.
Microbiological screening to reduce the risk of living donor-derived infection transmission
© 2017 Wolters Kluwer
Target population Confirmatory/ Implications of positive test for
Pathogens for testing Screening tests additional tests Timing of testing donation and management
HIV (1/2) All donor candidates Anti-HIV-1/2 Ab HIV NAT or HIV Ag/Ab At initial screening and • Donation from HIV+ persons contraindicated unless as part of an
or Ag/Ab combination assay within no longer than approved research protocol for HIV+ recipients
combination assay 28 d before donation
Case 2:24-cr-00366-NJC
HBV All donor candidates Anti-HBcAb and HBsAg HBV NAT At initial screening and • Donation from HBsAg + persons contraindicated for HBV− recipients,
within no longer than but may be considered for HBsAg+ recipients or recipients with HBV
28 d before donation protective immunity,275 with informed consent of the recipient, possible
antiviral HBV treatment of the recipient and posttransplant monitoring
• Donation from isolated HBcAb+ persons may be considered with
informed consent of the recipient and posttransplant monitoring;
consider HBV immunoglobulin and anti-HBV antiviral treatment
in nonimmune recipients
HCV All donor candidates Anti-HCV Ab At initial screening and • Donation from HCV+ persons contraindicated unless as part of an
Document 24-1
HCV NAT also recommended within no longer than approved research protocol for HCV+ recipients
C.Agnello in all donors71 28 d before donation
CMV All donor candidates Anti-CMV IgG Ab At initial screening • Use to guide posttransplant antiviral prophylaxis and monitoring in the
recipient, based on recipient serology and program protocol
EBV All donor candidates Anti-EBV IgG Ab (antiviral capsid At initial screening • Use to guide assessment for and monitoring of risk of posttransplant
antigen and/or lymphoproliferative disorder, especially in EBV-negative pediatric recipients
SE 0284 antinuclear antigen)
Treponema All donor candidates Rapid plasma reagin (RPR) Anti–T. pallidum Ab Perform or update • Donation from persons with latent syphilis may be considered after
pallidum (Syphilis) as close in time treatment of the donor candidate before donation, informed consent
to donation as of the recipient, and recipient monitoring after transplant
possible
Filed 03/11/26 #:
Mycobacterium Persons with any of the following Chest radiograph (may be Acid-fast bacilli Perform or update • Donation contraindicated from persons with active TB infection.
tuberculosis (TB) risk factors: suggestive but not diagnostic) staining, culture as close in time Consideration of donation after treatment of active TB should be
• Lived in endemic regions Tuberculin skin testing (TST) and/or NAT to donation as individualized
• Social or environmental risk factors or Interferon gamma release testing for active possible • Donation may be considered from persons with latent TB infection after
KDIGO Living Kidney Donor Work Group
such as: working in healthcare, assay (IGRA) infection initiation of chemoprophylaxis in the donor candidate before donation,
Page 287 of 569 PageID S65
jail/prison exposure, known TB informed consent of the recipient, and recipient monitoring after
exposure, homelessness, alcohol transplant
or other substance abuse
Continued next page
481
TABLE 17. (Continued) S66
Target population Confirmatory/ Implications of positive test for
Pathogens for testing Screening tests additional tests Timing of testing donation and management
Strongyloides Persons with any of the following Anti-Strongyloides IgG Ab Perform or update • Donation may proceed after treatment of the donor with an appropriate
risk factors: Serologic Ab testing as close in time antiparasitic agent such as ivermectin
• Born in or lived in tropical/subtropical preferred to stool to donation as
countries with substandard examination, as stool possible
sanitation screening tests may
• Significant exposure to soil in the be negative in asymptomatic
Appalachia or the Southeastern chronic infection286
United States including walking
Case 2:24-cr-00366-NJC
barefoot
• Unexplained eosinophilia and travel
to an endemic area
• Prior history of Strongyloides infection
Trypanosoma Persons with any of the following Anti-T. cruzi Ab T. cruzi NAT is insensitive Perform or update • Donation may be considered from persons with chronic Chagas disease
cruzi (Chagas) risk factors: (EIA or IFA test) for chronic phase as close in time after treatment of the donor candidate before donation, informed
• Born or lived in endemic areas of disease due to low to donation as consent of the recipient, and recipient monitoring after transplant
Mexico, Central and South America levels of parasitemia possible
• Children of women who lived in
Document 24-1
Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S
endemic area
C.Agnello • Recipients of blood transfusion in
endemic areas
• Prior history of Chagas Filed 03/11/26
WNV Persons with history of mosquito Anti-WNV IgM Ab is WNV NAT Within 7-14 d of • Donation should be delayed for 28 d when WNV NAT screening is
exposure or blood transfusions available, but WNV donation when positive, followed by repeat NAT and WNV IgM Ab testing, with further
SE 0285 • Risk varies by geography NAT advised in initial testing is indicated decisions based on combined results
and season screening 482
Histoplasmosis Persons who were born or lived in Chest radiograph Urine or serum Perform or update • Donation may be considered from persons with pulmonary-limited
endemic regions (eg, Midwestern (may be suggestive antigen testing as close in time histoplasmosis after treatment of the donor candidate before
United States, Mississippi or but not diagnostic) to donation as donation, resolution of clinical signs/symptoms and of antigenuria/
Ohio River valleys, St. Lawrence Anti-Histoplasmosis Ab possible antigenemia (if present at diagnosis), informed consent of the
River Valley in Canada, (complement fixation, recipient, and recipient monitoring after transplant
Gangetic West Bengal in India) immunodiffusion or EIA)
Coccidiomycosis Persons who were born or lived in Chest radiograph (may Urine or serum Perform or update • Donation may be considered from persons with Coccidiomycosis
desert areas of the Southwestern be suggestive but not antigen testing as close in time after treatment of the donor candidate before donation, resolution
United States diagnostic) to donation as of clinical signs/symptoms and of antigenuria/antigenemia
Anti-Coccidioides Ab possible (if present at diagnosis), informed consent of the recipient,
(complement fixation, and recipient monitoring after transplant
immunodiffusion or EIA)
Source: References71,273,275,276,286-291
Ab, antibody; Ag, antigen; CMV, cytomegalovirus; EBV, Epstein-Barr virus; EIA, enzyme immunoassay; HBcAb, hepatitis B core antibody; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; IFA, immunofluorescent antibody; IgG, immunoglobulin G; IgM, immunoglobulin M; NAT, nucleic
acid testing; WNV, West Nile Virus.
Page 288 of 569 PageID #:
www.transplantjournal.com
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 289 of 569 PageID S67
KDIGO Living Kidney Donor Work Group
#:
483
transplantation is well documented. Tests to detect HIV in- for HIV as close to the time of organ recovery as possible,
clude antibodies generated against HIVantigens, direct detec- using sensitive tests for both chronic and acute infections,
tion of viral nucleic acid (NAT testing) or HIV antigen p24. namely, antibody and NAT testing.284
Currently, antibodies against HIV antigens remain the most In 2013, the US PHS updated their “Guideline for Reduc-
commonly used method for detection of HIV. The period ing HIV, HBVand HCV Transmission through Organ Trans-
from HIV exposure to the development of HIV antibodies is plantation,” including recommended risk factor assessment in
approximately 22 days, but can be up to 6 months. Thus all donor candidates (Table 16).71 Living donor candidates
the donor may be seronegative while potentially infec- with behaviors associated with increased risk of acquiring
tious.283 NAT testing can reduce the window period for HIV, HBV or HCV identified during evaluation should receive
HIV to between 5.6 and 10.2 days.299 individualized counseling on specific strategies to prevent
In contrast to undetected donor disease transmission, med- exposure to these viruses during the period before dona-
ical advancements in HIV antiviral therapy have led to con- tion surgery. Recommendations regarding microbiological
sideration of planned kidney transplantation from HIV+ testing include:
donors to HIV+ recipients, such as recent experience described • All potential organ donors (living or deceased) should be
in South Africa.300 In the United States, the National Organ tested for antibodies to HIV (ie, anti-HIV 1/2 Ab or HIV
Transplant Act (NOTA) of 1984 prohibited the knowing antigen/antibody [Ag/Ab] combination assay). All potential
procurement or transplantation of organs from an HIV infected organ donors identified as being at increased risk for HIV
donor, but in 2013 the HIV Organ Policy Equity (HOPE) infection should also be tested for HIV RNA by NAT or HIV
Act repealed this prohibition and authorized the OPTN to antigen (eg, HIVAg/Ab combination assay). Donor blood spec-
develop standards for use of organs from known HIV infected imens should be obtained before procurement. Ab or Ag/Ab test
results should be made available before transplantation.
individuals in HIV infected recipients. At this time, such
donations and transplantation should occur only within the • All potential organ donors (living or deceased) should be
tested for both anti-HCV Ab and for HCV RNA by NAT.
context of research protocols; protocols in the United States
Donor blood specimens should be obtained before procure-
were developed by the National Institutes of Health (NIH).301 ment. Antibody test results should be made available before
transplantation.
Increased Risk Donors and Window Periods for HBV,
• All potential organ donors (living or deceased) should be
HCV and HIV
tested for anti-HBcAb and for HBsAg. Donor blood speci-
Serological testing for infections has been highly effective mens should be obtained before procurement. Ag/Ab test
in reducing the risks of donor-derived disease transmission. results should be made available before transplantation.
However, seroconversion requires the elaboration of anti- • As noted above, the guideline recommends that all living do-
bodies against a specific pathogen and could be delayed for nor candidates should be tested for HIV, HBV and HCV as
several weeks after infectious exposure. Testing during the close as possible to the date of the organ recovery operation,
window period for seroconversion may generate false- but within no longer than 28 days before surgery.
negative test results and could lead to inadvertent infection
transmissions. Cases of donor-derived infection transmis- Whether retesting closer to the time of transplantation (eg,
sions related to window period infections missed by serologic within 7 to 10 days before donation) is warranted to detect
screening of donors have been reported.274,283 The period new infections and reduce the window period, overall or among
from HIV exposure to the development of HIV antibodies is high-risk donor candidates, remains controversial.303,304 A
22 days on average, but can be up to 6 months.274 HBsAg survey of living donor transplant programs in New York
enzyme-linked immunosorbent assays (ELISAs) have a win- State in 2012 found that most responding programs had pol-
dow period of 38.3 to 49.7 days, while the time from HBV icies to retest living donors within 14 days of donation and
exposure to positive NAT testing ranges from 20.4 to 25.7 while there were rare cases of delays in donation associated
days. The window period for detection of HCV infection by with repeat testing, no cancellations occurred.305
ELISA is 38 to 94 days, but the duration of the window is
substantially reduced to 6.1 to 8.7 days by the use of NAT.274
In 2007 in the United States, a previously uninfected de- Epstein Barr Virus
ceased donor kidney transplant recipient tested positive for The presence of anti-EBV antibodies signifies prior donor
HIV and HCV infection. Routine donor serologic screening infection, with potential for reactivation of the latent virus
for HIV and HCV infection was negative; the donor's only and subsequent infection of the immunosuppressed recipient.
known risk factor for HIV was having sex with another While detection of the EBV in the living donor generally will
man. Four organs (2 kidneys, liver and heart) were not preclude donation, knowing that the kidney comes with
transplanted to 4 recipients. NAT of donor sera and latent EBV infection may be important in posttransplant re-
posttransplant sera from all recipients were positive for cipient care.306 Infection with EBV manifests as a spectrum
HIV and HCV.302 This case highlighted the potential for do- of diseases ranging from asymptomatic viremia to infectious
nors to harbor HIV and HCV infection during the window mononucleosis to posttransplant lymphoproliferative dis-
period, when infection cannot be detected by antibody order (PTLD).307 EBV disease and associated PTLD are more
screening. frequently seen when primary EBV infection occurs after
In 2009, a case of unexpected HIV transmission from a liv- transplant, a common scenario in EBV- pediatric solid organ
ing organ donor in New York City was also reported.284 transplant recipients who receive a kidney from an EBV+ do-
Based on this case, it was suggested that to reduce the risk nor. In the United States, the cumulative 1- and 5-year inci-
for transmission of HIV through living donor organ trans- dence of PTLD in 2010 was reported to be 1.3% and
plantation, transplant programs should screen living donors 2.4%, respectively, for pediatric kidney recipients but less
C.Agnello SE 0286
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 290 of 569 PageID #:
S68 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 484 www.transplantjournal.com
than 0.2% and 0.6% respectively, for adult recipients.307 As there are multiple available syphilis assays providing
When the donor is EBV+ and the recipient is EBV-, particu- different types of information, no single blood assay can con-
larly in pediatric recipients, clinical vigilance is required after clusively define an individual’s disease status. For donor can-
transplantation to detect PTLD.308 Intensity of EBV viral didate testing, specimen collection and the time available to
load and immunosuppressive therapies influence the risk perform testing must be considered in choosing an appropri-
for PTLD.307 ate donor screening assay.313 Living donor candidate evalua-
tion is less time constrained than the screening of deceased
Cytomegalovirus donors, and thus screening with nontreponemal assays
Cytomegalovirus disease may result from reactivation of followed by confirmation with treponemal assays is preferred
latent infection or primary infection transmitted by a kidney if feasible.
from a CMV+ donor. The laboratory methods for CMV di- Transmission of syphilis has been reported in the United
agnosis are serology, culture, antigenemia, and molecular Kingdom to 2 recipients from a deceased donor with a past
methods such as CMV NAT, which is most commonly per- history of treated disease, supporting recommendations of
formed using real-time polymerase chain reaction.309 The penicillin for treatment of recipients of deceased donor or-
main clinical utility of CMV serology is stratification of a gans from serologically reactive donors.312 Donation from
transplant recipient’s risk of CMV disease based on donor living persons with latent syphilis may be considered after
and recipient status.279,280,310 treatment of the donor candidate before donation (eg, with
The presence of anti-CMVantibodies in a donor candidate penicillin), informed consent of the recipient, and recipient
indicates prior infection, with the potential that the latent vi- monitoring after transplant.
rus will reactivate and cause infection, particularly in the
CMV- recipient. The detection of anti-CMV antibodies does Tuberculosis (TB)
not preclude donation, and infection risk can be anticipated
The incidence of posttransplant TB varies substantially de-
and managed. Primary CMV infection is generally more se-
pending on the local prevalence of TB infection, which ranges
vere than reactivation and recipients at highest risk are those
from 1% in Germany to nearly 14% in India.290 Studies in
who are CMV seronegative and receive a kidney transplant
the United States and Europe have estimated that 0.35% to
from a CMV seropositive donor. Matching CMV seronega-
6.6% of transplant recipients develop TB (across organ and
tive recipients with CMV seronegative donors is an effective
donor types), and that 4% posttransplant TB cases are
strategy for reducing the risk of CMV infection but is rarely
donor-derived.290,315 TB is one of the more common bacte-
practical in the context of living donor kidney transplanta-
rial causes of donor-derived infection in the United States.316
tion. CMV seropositive recipients may develop disease reac-
Consensus-based recommendations for the diagnosis and
tivation or donor-related infection. Thus organ donors and
management of TB in organ donors include:288,290,317
recipients should be tested for prior (latent) CMV infection
using anti-CMVantibody for risk stratification and guidance • Risk stratification of all donor candidates, according to:
of appropriate surveillance and/or antiviral prophylaxis after
◯ Place of birth, residence or travel to a geographically endemic
transplantation.311 region, with increased risk defined by residence greater than
3 months or relief work in a high prevalence region
Syphilis ◯ Social risk factors including working in healthcare, prison
Transmission of syphilis by organ transplantation has exposure/incarceration, known TB contact, homelessness,
been documented.312 In the United States, all assays currently alcohol or other substance abuse
FDA-approved for detecting evidence of T. pallidum infection ◯ Medical risk factors including history of untreated TB or ra-
in organ and tissue donors are serologic assays.313 There are diographic evidence of prior TB; underweight BMI and dia-
2 types of serologic assays: nontreponemal and treponemal. betes have also been correlated with increased TB risk
Nontreponemal assays use a combination of cardiolipin, cho- • Chest radiograph in all donor candidates
lesterol, and other lipid substances released from damaged • Consideration of urinalysis with microscopy, genitourinary
cells as the antigenic source to detect antibodies against imaging, urine acid-fast bacilli smear and culture in living do-
nor candidates from countries with intermediate to high TB
cardiolipin, which circulates in the sera of individuals infected
prevalence
with syphilis and may also be present in individuals with a va-
• Consideration of immune-based diagnostic testing by tuber-
riety of other conditions. Reactivity to cardiolipin generally culin skin testing (TST) or the interferon-gamma release assay
disappears within a year or 2 after successful treatment of (IGRA)
syphilis.313 Treponemal assays detect T. pallidum antibodies, ◯ Diagnostic tests for latent TB infection are limited in sensi-
which tend to remain elevated for life. Therefore, treponemal tivity and have a relatively low predictive value for develop-
assays cannot distinguish between recent, remote, and previ- ment of active TB.318 The specificity of TST is related to the
ously treated infection. Donors are screened for serological ev- burden of TB in that region or country, and IGRA has supe-
idence of syphilis with a nontreponemal assay such as the rior specificity in populations where use of Bacillus
rapid plasma reagin (RPR) or venereal disease research labora- Calmette-Guérin vaccination is common based on use of
tory (VDRL) test, which should be confirmed later with a trep- specific antigens absent in Bacillus Calmette-Guérin strains
◯ Immune testing of all donor candidates or selective testing
onemal Ab immunoassay. A recent study found that current
based on risk profile are considered acceptable options
screening of deceased organ donors by RPR yields a significant
◯ Persons with positive immune-based TB testing who are
number of false-positive results. Use of alternative tests or the asymptomatic and do not have signs of active TB are con-
routine use of confirmatory tests may reduce the frequency sidered to have latent TB infection
of false-positive syphilis results in potential deceased and living • Donation from persons with active TB is contraindicated.
organ donors.314 Risk of transmission from donors with prior appropriately
C.Agnello SE 0287
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 291 of 569 PageID S69
KDIGO Living Kidney Donor Work Group
#:
485
treated active TB appears to decline with longer time from TABLE 18.
treatment. Donation may be considered with informed con-
Social and clinical factors associated with increased
sent of the recipient, consideration of recipient chemopro-
phylaxis under the guidance of an infectious disease specialist, likelihood of geographically endemic infections and infections
and recipient monitoring after transplant. related to specific exposures
• Living donor candidates with latent TB infection should be
offered chemoprophylaxis according to local or national Geographic risks (including duration of time spent in a location)
guidelines. Donation may be considered from persons with la- • Home country/region
tent TB infection with informed consent of the recipient and • Place of birth (outside vs inside home region)
recipient monitoring after transplant. As there are no data • Prolonged residence outside home region (recent or distant)
on optimal duration of treatment before donation, individ- • Occupational or recreational travel to other countries and/or regions
ualization of the timing of donation in relation to start of • Countries of origin for close family members
donor chemoprophylaxis is recommended. Chemoprophy- • Ingestion of well water
laxis of recipients from donors with latent TB infection Occupational risks
should also be considered, especially if the donor did not • Healthcare workers
complete chemoprophylaxis before donation.317
• Veterinarians, animal care workers
• Landscapers, park rangers, and other outdoor workers
A recent study in Korea, a country with an intermediate • Occupations with international travel, such as Peace Corps,
prevalence of TB, prospectively evaluated living donors using international journalists
the TST and Mycobacterium tuberculosis-specific enzyme- • Medical mission trips (consider a 3-mo washout period before
linked immunosorbent spot (ELISPOT) IGRA.319 Among donation to allow identification of subclinical disease)
the 205 living donors, 31% had a positive TST and 47% Seasonal risks
had a positive ELISPOT. Based on the high rate of suspected • Warm weather and insect exposure—eg, local West Nile Virus,
latent TB infection detected by screening living donors using dengue, Chikungunya virus, local rickettsial infections, Lyme disease
TST and ELISPOT in a country with a TB intermediate prev- Hobbies
alence, the authors recommended further study of the cost ef- • Hunting/dressing game, taxidermy
fectiveness of recipient TB chemoprophylaxis.319 • Time living outdoors including camping, swimming in lakes,
drinking stream water, insect exposures
Urine Culture • Adventure sports
Urine should be sent for culture from all donor candidates • Gardening
at evaluation, and ideally repeated close to the time of dona- Significant animal exposure (wild and/or domestic)
tion (eg, within the preceding 2 weeks). Acute symptomatic • Large numbers of cats or dogs or any unusual pets, including
urinary tract infection is a reason to postpone donation. whether pets reside mainly indoors or outdoors
However, detection of asymptomatic bacteriuria is not infre- • Laboratory/research animals
quent, especially in female donors. A history of urinary tract • Veterinarian/veterinarian assistant
infection in a donor candidate, particularly if there is a family Family members and close contacts with potential risk factors
history of reflux nephropathy, or in a male, requires detailed • Geographic or seasonal infections previously diagnosed in close
imaging of the kidneys (eg, assessment for cortical scarring). family members or other contacts may predict risk for subclinical
Any active bacterial or fungal infection in the donor should infection in donor candidate
be treated and, ideally, resolved before donation and trans- Personal history of seasonal or geographic infection in donor candidate,
plantation.283 Antibiotic prophylaxis should be given to the even if remote
recipient if resolution of infection is not confirmed before do- Adapted from OPTN Ad Hoc Disease Transmission Advisory Committee287
nation, as a positive urine culture early after transplantation,
even when asymptomatic, may be associated with increased
risk of acute rejection in the recipient.320,321 informed consent of the recipient, as well as recipient monitor-
ing and possible prophylaxis after transplant (Table 19).
Seasonal and Geographically Endemic Infections Strongyloidiasis typically occurs only in the setting of specific
The donor candidate evaluation should include assessment of environmental exposures. Donor-derived Strongyloides hyper-
place of residence, travel, seasonal, occupational, and recreational infection cases with high associated mortality have been
risks, as well as prior infections in the donor candidate and fam- reported, including from kidney transplantation.322-324
ily members (Table 17). A number of geographically endemic Consensus-based recommendations of the 2013 AST Infec-
and seasonal diseases have been transmitted through organ tious Diseases Community of Practice work group and the
donors including: Strongyloides, Trypanosoma cruzi (Chagas OPTN Ad Hoc Disease Transmission Advisory Committee
disease), West Nile virus, histoplasmosis, coccidiomycosis, (DTAC) support screening for Strongyloides in the following
Aspergillus, toxoplasmosis, malaria, Creutzfeldt–Jacob potential organ donors286,287:
disease, human T-cell lymphotrophic virus infection, and
• Persons who were born in or lived in tropical or subtropical
schistosomiasis.273,275,286 Other viral, fungal, bacterial and
countries where sanitation conditions are substandard, in-
parasitic pathogens recognized as sources of organ donor- cluding candidates with prior military service in endemic
derived infection transmissions are listed in Table 18. Living areas. The WHO emphasizes a correlation between improved
donation affords sufficient time for microbiological testing, sanitation and human waste disposal with the disappearance
donor treatment and deferral of donation and transplantation of Strongyloidiasis.325 Strongyloidiasis has occurred in most
until resolution of infection. Organ donation may be possible countries with the exception of Canada, Japan and Northern
after treatment of the donor candidate before donation, Europe.
C.Agnello SE 0288
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 292 of 569 PageID #:
S70 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 486 www.transplantjournal.com
TABLE 19. • Those who were born in or lived in an endemic region in
Mexico, Central or South America
Recognized organ donor-derived infection transmissions
• Children of women who lived in endemic regions and whose
Viruses Bacteria T. cruzi infection status is positive or unknown
Adenovrius Mycobacterium tuberculosis • Persons who received a blood transfusion in endemic regions
• Persons reporting a prior history of Chagas disease
BK polyoma virus Nocardia spp.
Cytomegalovius Rickettsia rickettsii (Rocky
Epstein-Barr virus Mountain Spotted Fever) Assessment of outcomes of 32 transplant recipients who
Herpes simplex virus Treponema pallidum (syphillis) received organs from 14 T. cruzi seropositive donors in the
HIV Borrelia (Lyme disease) United States from 2001 to 2011 confirmed transmission
HBV in 9 recipients from 6 donors, including 2 of 15 (13%) kid-
HCV ney recipients, 2 of 10 (20%) liver recipients and 3 of 4 (75%)
Hepatitis E virus heart recipients.326 Recommended monitoring posttransplant
Human T-cell lymphotropic comprised regular testing by polymerase chain reaction, hemo-
virus 1 and 2 culture, and serologic testing. Thirteen recipients had no or
Influenza A/B incomplete monitoring; transmission was confirmed in 5 of
Lymphocytic choriomeningitis virus these recipients; 4 of the 5 recipients had symptomatic disease
Parvovirus B19 and all 4 died, although death was directly related to Chagas
Rabies disease in only one. Nineteen recipients had partial or com-
West Nile virus plete monitoring for T. cruzi infection with weekly testing by
Fungi Parasites polymerase chain reaction, hemoculture and serologic testing;
Aspergillus spp. Babesia microti transmission was confirmed in 4 of the 19 recipients with
Candida spp. Balamuthia mandrillaris no cases of symptomatic disease. Based on such evidence, re-
Coccidioides immitis Malaria spp. cent guidelines support consideration of kidney donation
Cryptococcus neoformans Naegleria fowleri from donors with T. cruzi infection on an individual basis
Histoplasma capsulatum Toxoplasma gondii with consent of the recipient.286,287,289 Recipients must be in-
Scopulariopsis brevicaulis Trypanosoma cruzi formed of the need for participation in close monitoring and
Zygomycetes (Mucor) Schistosoma spp. the available therapeutic interventions in the event of infec-
Strongyloides stercoralis tion, as the medications available for treatment are not
FDA-approved and are generally only available through
HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus. Adapted by permis-
sion from Macmillan Publishers Ltd: Fishman JA, Grossi PA. Donor-derived infection—the challenge for specific protocols. Consideration of the recipient’s access to
transplant safety. Nat Rev Nephrol. 2014;10:663–672.274 testing and monitoring is imperative, as geographic concerns
may impact the ability to follow the recipient closely.
• Persons with significant exposure to soil in Appalachia or the West Nile Virus is a flavivirus that is transmitted by mos-
Southeastern United States, including walking barefoot.
quitoes in an enzootic cycle with birds. When testing is indi-
• Persons with unexplained eosinophilia and travel to endemic
area. cated, screening living donor candidates by West Nile virus
• Persons reporting a prior history of Strongyloides infection. NAT within 7 to 14 days of donation has been recom-
mended.273,291 Proposed strategies for when to begin testing
Serologic Ab testing is the preferred screening test for living donor candidates for West Nile virus include when re-
Strongyloides infection, as the sensitivity of stool testing is lim- gional blood banks start performing NAT screening or testing
ited and multiple stool screening tests may be negative in asymp- during a defined period of time that reflects the peak of local
tomatic chronic infection.286 Strongyloides IgG antibody testing West Nile virus infection.291 The 2013 AST Infectious Diseases
(ELISA-based) is available in many reference labs. Community of Practice work group recommended delaying do-
Infected donor candidates should be treated with a mini- nation for 28 days when NAT screening is positive, followed by
mum of 2 doses of ivermectin before donation (200 µg/kg repeat NAT and immunoglobulin M (IgM) Ab testing with the
orally daily on 2 consecutive days)286,287 Because of the poten- following management pathways based on the results273:
tial for persistence of migrating larvae and eggs in the tissues,
• NAT+: Defer donation for at least 120 days. Donation
some experts recommend repeating this treatment 2 weeks deemed likely to be safe if clearance of viremia demonstrated
later to cover an autoinfection cycle. After treatment, follow- by NAT testing after 120 days
up laboratory testing of the donor candidate before donation • NAT-/IgM Ab−: Consider initial NAT testing to reflect a false
to confirm cure has been deemed unnecessary, unless reexpo- positive result. Donation may be considered after infectious
sure has occurred286,287 disease consult
Chagas disease is transmitted through contact with in- • NAT-/IgM Ab+: Suggests infection with clearance of viremia.
fected triatomine “kissing” bugs, and residents of poorly con- Donation may be considered after infectious disease consult
structed housing where these insects reside are at greatest risk
of acquiring infection. Transmission has also been reported Emerging Infections
from mother to infant, through blood transfusion, and through Transplant programs must maintain awareness of new
organ transplantation. Consensus-based recommendations of and emerging infections that may be transmissible through
the 2011 Chagas in Transplant Working Group, the 2013 organ donation. Availability of microbiological testing for
AST Infectious Diseases Community of Practice work group, new infections may be limited or available only at specialized
and OPTN DTAC support screening in the following poten- laboratories, emphasizing the importance of careful assess-
tial organ donors286,287,289: ment of exposure history in the donor candidate evaluation.
C.Agnello SE 0289
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 293 of 569 PageID S71
KDIGO Living Kidney Donor Work Group
#:
487
For example, during the Ebola virus outbreak of 2014, the and risk factors for possible exposure. Also, since the Spanish
OPTN DTAC recommended that evaluation of candidates Society of Nephrology and Spanish National Transplant Or-
for organ donation should include screening for travel and ganization guidelines were published in 2010,54 new research
epidemiologic risk factors for Ebola exposure, including327: published above supports revision of some categories of [a]
‘Donation is contraindicated with positive results.’
• Travel to a country where an Ebola outbreak occurred within
the past 21 days
• Contact with blood, other body fluids, or human remains of a RESEARCH RECOMMENDATIONS
patient known or suspected to have Ebola
• Exposure as a healthcare worker to patients known to have • Define the incidence of donor-derived disease transmission
Ebola through improved monitoring and reporting. This is critical
• Direct handling of bats or nonhuman primates from disease- since determining the relative importance of specific patho-
endemic areas gens and risk mitigation strategies requires collection of global
data.
If risk factors for Ebola are identified, the OPTN DTAC • Develop and validate risk assessment questionnaires and pro-
recommends aborting the evaluation process and excluding tocols for living donor-derived infections, taking into consid-
donation. eration behavioral, occupational, hobby-related, geographic
Zika virus is a mosquito-borne pathogen that gained at- and seasonal exposures.
• Optimize and standardize methods of microbiological assays
tention in association with an outbreak of primary micro-
for donor infection screening and diagnosis.
cephaly among children born to infected mothers in Brazil • Assess results of planned US NIH studies of transplantation
in 2015, followed by rapid geographic spread across the from HIV+ donors to HIV+ recipients to develop guidance
Americas, prompting recognition as a global health emer- on appropriate consideration of such transplants in clinical
gency.328 Other complications of Zika virus infection include practice.
acute autoimmune neuropathies such as Guillain-Barré syn- • Determine, through clinical trials or observational protocols
drome. Guidance from the OPTN DTAC, the AST, and the with informed consent, whether kidney donation and trans-
ASTS recommend considering donor deferral if there is his- plantation can be performed with acceptable safety and out-
tory of travel to Zika-endemic areas in the 28 days before do- comes for the donor and recipient in the following scenarios:
nation.329 In the case of potential living donors with Zika ◯ Donation from HCV+ living donors to HCV+ recipients after
infection, donation should be deferred where possible. antiviral treatment of the donor
Transplant programs should develop and maintain screen- ◯ Donation from HBsAg + living donors to HBsAg + recipients
ing protocols to address emerging infections, including aware- or recipients with HBV
ness of evolving geographic exposure patterns in consultation
with local public health specialists. Current information on CHAPTER 13: CANCER SCREENING
global health outbreaks are reported by organizations such The ERT search parameters did not identify evidence from
as the US Centers for Disease Control.330 eligible studies pertinent to the recommendations in chapter
13 and therefore the following recommendations are “Not
What Prior Guidelines Recommend Graded.”
US OPTN Policy for Medical Evaluation Requirements for
Living Donors mandates similar screening tests as recom- Evaluation
mended in our current guideline: anti-CMV Ab, anti-EBV 13.1: Donor candidates should undergo cancer screening con-
Ab, anti-HIV 1,2 Ag/Ab, HBsAg, anti-HBcAb, anti-HCV sistent with clinical practice guidelines for the country or
Ab, and syphilis testing.51 US transplant programs are re- region where the donor candidate resides. Transplant
quired to determine whether the donor has TB exposure risk programs should ensure that screening is current accord-
factors and to test accordingly. US programs are also re- ing to guideline criteria at the time of donation.
quired to develop protocols to determine who to screen
for geographically endemic and seasonal infections such Selection
as Strongyloides, Trypanosoma cruzi and West Nile virus.
13.2: In general, donor candidates with active malignancy
The British Transplantation Society has also recom-
should be excluded from donation. In some cases of ac-
mended testing for HBV, HCV, EBV, CMV and HIV as part tive malignancy with low transmission risk, a clear man-
of donor candidate evaluation.48 The Spanish Society of agement plan and minimal risk to the donor, donation
Nephrology and Spanish National Transplant Organization may be considered.
recommendations for living donor kidney transplantation in- 13.3: A kidney with a small simple (Bosniak I) cyst can be left
cluded the following as routine tests in the donor candidate in the donor, particularly if there are compelling reasons
evaluation: HIV [a], Hepatitis B: HBsAg [a], anti-HBcAb for donating the contralateral kidney.
IgM/IgG [b], HBsAb, HBV DNA in plasma if anti-HbcAb+, 13.4: Donation of a kidney with a Bosniak II renal cyst should
Hepatitis C (ELISA and polymerase chain reaction) [a], proceed only after assessment for the presence of solid
CMV IgG/IgM [b], EBV IgG/IgM [b], Toxoplasma test, components, septations, and calcifications on the preop-
erative computed tomography scan (or magnetic reso-
Syphilis (RPR- fluorescent treponemal antibody) [b], Bru-
nance imaging) to avoid accidental transplantation of
cella [b]. Here, [a] stands for ‘Donation is contraindicated a kidney with cystic renal cell carcinoma.
with positive results’ and [b] stands for ‘Donors and/or recip- 13.5: Donor candidates with high grade Bosniak renal cysts
ients have to undergo treatment with positive results’.54 (III or higher) or small (T1a) renal cell carcinoma cur-
In contrast to this recommendation, we believe that testing able by nephrectomy may be acceptable for donation
for Toxoplasma and Brucella should be guided by geography on a case-by-case basis.
C.Agnello SE 0290
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 294 of 569 PageID #:
S72 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S
488 www.transplantjournal.com
13.6: Donor candidates with a history of treated cancer that registry studies describing the outcomes of kidney transplant
has a low risk of transmission or recurrence may be ac- recipients with donor-derived cancer transmission published
ceptable for donation on a case-by-case basis. through December 2012.335 Among 104 donor-transmitted
cancer cases identified from 69 studies, the most common
RATIONALE transmitted cancer types were renal cancer (n = 20, 19%),
followed by melanoma (n = 18, 17%), lymphoma (n = 15,
Goals of Evaluation 14%) and lung cancer (n = 9, 9%). Recipients with transmit-
The goals of malignancy screening are two-fold. First, it is ted renal cancers had the best outcomes, with more than
necessary to identify cancers to protect the health of the do- 70% of recipients surviving for at least 24 months after trans-
nor candidate. Reduced kidney function may compromise plantation. Patients with melanoma and lung cancers had the
long-term health outcomes in individuals requiring cancer worst prognosis, with less than 50% of recipients surviving
treatments with nephrotoxic or cardiovascular side effects beyond 24 months from transplantation. While these data
(eg, some chemotherapies or radiation treatments). Potential support that donor-derived cancer transmission is uncom-
psychosocial stresses of living donation may also be prohibi- mon, potential reporting-bias prevents accurate incidence es-
tive in individuals faced with stress of an active cancer diag- timates. This report highlights the high mortality associated
nosis and treatment. Second, the evaluation must mitigate with donor-derived melanoma and lung cancer transmission.
risks of donor-derived malignancy transmission to the trans- A history of melanoma is particularly concerning when
plant recipient. evaluating a living donor candidate. Aside from the potential
for late recurrence and subsequent complications in the do-
General Population Cancer Screening and Incidence nor, melanoma transmission to transplant recipients has been
Most jurisdictions have regional recommendations for reported after apparent dormancy in the donor for decades,
which members of the general population should be screened supporting the ability of melanoma cells to remain dormant
for common cancers, including frequency of screening and at distant sites for decades and then reactivate upon exposure
acceptable testing modalities. These include screening recom- to immunosuppression,336,337 and transmission can be fatal.
mendations for colon, breast, cervical, prostate, and lung The Israel Penn International Transplant Tumor Registry, a
cancer.331-333 There are potential harms associated with can- voluntary registry of more than 250 cases of organs
cer screening, as with any form of screening, if additional transplanted from donors with a history of malignancy that
testing and procedures are undertaken in patients who ulti- captures tumor histology, donor risk factors, method of tu-
mately do not have cancer. These risks should be included mor presentation and recipient outcome, described 13 do-
in the consent for evaluation of the living donor candidate. nors with a history of melanoma (but deemed free of the
Transplant programs in countries without local clinical prac- disease at donation) who provided organs to 28 recipi-
tices guidelines can refer to guidelines from countries or re- ents.338,339 Melanoma transmission occurred in 21 recipients
gions most similar to their population.331-333 (75%), of whom 13 (62%) died from metastatic disease. The
The limited available data on cancer diagnoses after living time to diagnosis ranged from 2.5 to 42 months (median,
kidney donation support that donor evaluation and selection 10.5 months), and the only patients who survived were those
practices reduce the incidence of postdonation cancer below who underwent nephrectomy and cessation of immunosup-
that of general population controls, although risk reduction pression. While some prior general population guidelines
may dissipate with time after donation.334 However, cases such as the US Preventative Services Task Force state that
of cancer diagnoses including melanoma and uterine cancer there is insufficient evidence to recommend routine whole
within less than 1 year of donation have been reported,334 body skin exam screening among general adults,340 skin ex-
emphasizing the need for up-to-date assessment for malig- aminations for donor candidates with increased recreational
nancy before donation. or occupational exposure to sunlight, family or personal his-
tory of skin cancer, or clinical evidence of precursor lesions
may be warranted. Pathology reports of living donor candi-
Recurrence Risk after Treated Cancer
dates with a prior history of skin cancer resection should be
Recurrence rates after treated cancer from the general pop- reviewed to ensure that the cancer was not a melanoma be-
ulation may be used to guide observation periods after cancer fore approving donation.
treatment before considering organ donation. Average times
to recurrence vary by cancer type. Consideration of living do- Selection
nation from a person with a history of treated cancer should In 2011, the OPTN DTAC Malignancy Subcommittee
include consultation with the donor candidate’s oncologist to published a classification of 6 risk categories for donor-
confirm that individual case factors are associated with derived malignancy transmission and suitability of organ
“low” (eg, less than 1%) risks of both lifetime recurrence donation from persons with active or prior malignancy
and disease transmission, and that long-term surveillance will histories341; this was also recently reviewed in Kirchner
not require frequent imaging that may be restricted by re- et al.273 Classification was based on review of cancer regis-
duced GFR (eg, CT scans with iodinated contrast or magnetic try reports, published literature, and data submitted to the
resonance imaging (MRI) scans requiring gadolinium). OPTN. This article did not differentiate between cancer
transmissions from living compared with deceased donors
Donor-Derived Malignancy Transmission due to limited data.
Cases of malignancy transmission from deceased or living
organ donors to recipients have been reported. A recent sys- • “No significant risk” was defined as benign tumors where ma-
tematic review examined all case reports, case series and lignancy has been excluded.
C.Agnello SE 0291
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 295 of 569 PageID S73
KDIGO Living Kidney Donor Work Group
#:
489
• “Minimal risk” was defined as tumors with 0% to 0.1%
A benign simple cyst with a hairline thin wall that does not contain septa, calcifications, or solid components. It measures water density and does not enhance
transmission events per organ transplanted from donors with
the specific tumor, and includes nonmelanoma skin cancers,
noninvasive carcinoma of the bladder (for nonrenal transplants
only), small papillary or follicular carcinoma of the thyroid and
A benign cyst that may contain a few hairline thin septa in which “perceived” enhancement may be present. Fine calcification or a short segment of slightly thickened calcification
solitary, well-differentiated (≤1 cm) renal cell carcinoma.
• “Low risk” (0.1-1% transmission events per organ transplanted
from affected donors) includes small renal cell carcinoma
(1-2.5 cm), low grade central nervous system (CNS) tu-
mors, primary CNS mature teratoma, solitary papillary
thyroid carcinoma (0.5-2.0 cm), minimally invasive follicu-
lar carcinoma (1.0-2.0 cm), and history of treated non-CNS
may be present in the wall or septa. Uniformly high attenuation lesions < 3 cm (so-called high-density cysts) that are well marginated and do not enhance are included in this group.
malignancy (≥5 years prior) with greater than 99% proba-
bility of cure.
• “Intermediate risk” (1-10% transmission events per organ
transplanted from affected donors) includes breast and colon
carcinoma in situ, resected well differentiated renal cell carci-
noma (4-7 cm) and history of treated non-CNS malignancy
Cysts in this category do not require further evaluation
(≥5 years prior) with probability of cure between 90-99%.
• “High risk” (>10% transmission events per organ transplanted
from affected donors) includes current or past history of mela-
noma, leukemia/lymphoma or neuroendocrine tumors, breast
or colon cancer stage 1 or higher, choriocarcinoma, any CNS
Cysts that may contain multiple hairline thin septa or minimal smooth thickening of their wall or septa. Perceived enhancement of their septa or wall may be present. Their wall or septa
tumor with vetriculoperitoneal or ventriculoarterial shunt, me-
tastasis or high grade (III/IV) histology, metastatic carcinoma,
sarcoma, lung cancer Stage I-IV, and renal cell carcinoma
greater than 7 cm. The high risk category also included any
treated non-CNS malignancy with insufficient follow-up to pre-
dict behavior, incurable or with <90% probability of cure, or
Description may contain calcification that may be thick and nodular, but no measurable contrast enhancement is present. These lesions are generally well marginated. Totally intrarenal nonenhancing
any other active cancer not previously classified.
• Tumors of “unknown risk” were defined as a final category.
The authors suggested that donors in the “no significant
risk” category are standard, and that organs from donors
Reprinted with permission from Israel GM, Bosniak MA. An update of the Bosniak renal cyst classification system. Urology. 2005;66:484–488.343
with “minimal risk” malignancies may be used for transplan-
high-attenuation renal lesions > 3 cm are also included in this category. These lesions require follow-up studies to prove benignity
tation based on clinical judgment with informed consent of
the recipient. The authors also proposed that organs from do-
nors with “intermediate risk” malignancies could be consid-
ered for transplantation with informed consent for recipients
“Indeterminate” cystic masses that have thickened irregular or smooth walls or septa in which measurable enhancement is present. These are surgical lesions, although some will prove to be benign
who face substantial mortality without transplantation. This
classification scheme should be updated with new informa-
tion as data become available.
Considerations Related to Renal Cysts and Renal
Cell Carcinoma
(eg, hemorrhagic cysts, chronic infected cysts, and multiloculated cystic nephroma), some will be malignant, such as cystic renal cell carcinoma and multiloculated cystic renal cell carcinoma
The development of kidney cancer in a patient with a sin-
gle kidney is very concerning because the surgical treatment of
renal tumors may result in loss of function of the remaining
kidney. The age-stratified lifetime cumulative incidence of
kidney cancer is low. In a matched cohort study of 2119 do-
These are clearly malignant cystic masses that can have all the criteria of category III, but also contain enhancing soft-tissue components adjacent to, but independent of, the wall or septum.
nors in Ontario Canada (1992-2010) and 21 190 nondonors
Bosniak renal cyst classification system
from the general population with similar baseline health, no
living kidney donor in the cohort received a partial or total
nephrectomy of their remaining kidney during follow-up.342
The decision to approve donation in a person with kidney
These lesions include cystic carcinomas and require surgical removal
cysts depends on radiographic characteristics (Tables 20 and
21). Because simple (Bosniak I) renal cysts are not associated
with increased risk of complications, organ dysfunction, or
cancer, simple cysts are not contraindications to kidney
donation. Cases of back table excision of small renal cell
IIF (F for follow-up)
carcinomas after donor nephrectomy, followed by use of
TABLE 20.
the kidney for transplantation have been reported.345-348
Based on review of cancer registry reports, published
Category
literature and disease transmission cases reported to the
OPTN, a 2011 OPTN DTAC Malignancy Subcommittee I
II III IV
C.Agnello SE 0292
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 296 of 569 PageID #:
S74 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 490 www.transplantjournal.com
TABLE 21.
International TNM staging system for renal cell carcinoma
T: Primary tumor
TX Primary tumor cannot be assessed
T0 No evidence of primary tumor
T1a Tumor ≤ 4.0 cm and confined to the kidney
T1b Tumor > 4.0 cm and ≤ 7.0 cm and confined to the kidney
T2a Tumor > 7.0 cm and ≤ 10.0 cm and confined to the kidney
T2b Tumor > 10.0 cm and confined to the kidney
T3a Tumor grossly extends into the renal vein or its segmental (muscle-containing) branches, or tumor
invades perirenal and/or renal sinus fat but not beyond Gerota fascia
T3b Tumor grossly extends into the vena cava below the diaphragm
T3c Tumor grossly extends into the vena cava above the diaphragm or invades the wall of the vena cava
T4 Tumor invades beyond Gerota fascia (including contiguous extension into the ipsilateral adrenal gland)
N: Regional lymph nodes
NX Regional lymph nodes cannot be assessed
N0 No regional lymph nodes metastasis
N1 Metastasis in regional lymph node(s)
M: Distant metastases
MX Distant metastasis cannot be assessed
M0 No distant metastasis
M1 Distant metastasis present
Stage grouping
Stage I T1 N0 M0
Stage II T2 N0 M0
Stage III T1 or T2 N1 M0
T3 Any N M0
Stage IV T4 Any N M0
Any T Any N M1
Reprinted from Campbell SC, Lane BR. Chapter 57: Malignant renal tumors. In: Campbell-Walsh Urology, 11th Edn. Wein AJ, Kavoussi LR, Partin AW, et al. (eds). Elsevier, pp. 1314–1364, 2016.344
concluded, from a disease-transmission perspective, that “… or higher cysts should not be left in the donor but such de-
kidneys with small, solitary, well differentiated renal cell cision should be individualized.
carcinoma may be usable for transplantation provided the
lesion itself is completely resected."341 While partial (rather What Prior Guidelines Recommend
than complete) nephrectomy is often the treatment choice Prior guidelines and policies for the evaluation and care of
for small renal cell carcinomas for the purpose of nephron- living donors recommend history, clinical examination, and
sparing with comparable cure rates in affected individuals, investigation to exclude occult malignancy before donation,
persons planning kidney donation intend to undergo com- especially in those older than 50 years or with risk factors includ-
plete nephrectomy. Thus, the decision to proceed with donor ing family history.38,48,51 The Amsterdam Forum recognized that
nephrectomy in an individual with a high grade Bosniak risks of specific cancers may vary across countries.38 “Active ma-
cysts or suspected kidney cancer based on predonation im- lignancy” is commonly cited as a contraindication to living
aging should incorporate considerations of the anticipated kidney donation,38,48,51 although exceptions were noted for
risk of future carcinoma in the donor’s contralateral kidney, low-grade nonmelanoma skin cancer.38 Renal cell carcinoma
risk of disease transmission to the recipient (including was considered a contraindication to donation in some prior
whether the lesion is amenable to complete back table exci- guidelines,38,48 but is currently permissible under US policy
sion), chances of possible discard without transplantation in selected cases.51
after nephrectomy. Donation of a kidney with a Bosniak II Past cancers considered to be an absolute contraindication
renal cyst should proceed only after assessment for the pres- to donation in prior guidelines include melanoma, testicular
ence of solid components, septations, and calcifications on cancer, choriocarcinoma, hematological malignancy, mono-
the preoperative computed tomography scan (or magnetic clonal gammopathy, bronchial cancer, and metastatic can-
resonance imaging) to avoid accidental transplantation of a cer.38,48 Breast cancer is included, although the European
kidney with cystic renal cell carcinoma. Procurement and Association of Urology qualifies the restriction to “ad-
transplantation of living donor kidneys with Bosniak (III vanced” disease.55 Criteria for which donation may be ac-
or higher) renal cysts or small (T1a) renal cell carcinoma ceptable despite a prior history of malignancy articulated in
curable in the donor by nephrectomy and amenable to prior guidelines include that the specific cancer is curable
complete excision before implantation should proceed and the potential transmission of the cancer can reasonably
only after detailed informed consent of donor and recipi- be excluded (eg, colon cancer (Dukes A, > 5 years ago),
ent, and donor and recipient understanding and accep- nonmelanoma skin cancer, or carcinoma in situ of the cer-
tance of these risks. In most circumstances, Bosniak IIF vix).38,48 The Amsterdam Forum defined additional criteria
C.Agnello SE 0293
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 297 of 569 PageID S75
KDIGO Living Kidney Donor Work Group
#:
491
for approving donation in a person with prior cancer to in- they meet age-specific imaging or genetic testing criteria
clude that prior treatment of the malignancy did not decrease that reliably exclude ADPKD.
renal reserve, place the donor at increased risk for ESKD, or
increase the operative risk of nephrectomy.38 Apolipoprotein L1 (APOL1) Risk Alleles
RESEARCH RECOMMENDATIONS 14.8: Apolipoprotein L1 (APOL1) genotyping may be offered
to donor candidates with sub-Saharan African ancestors.
• Improve quantification of the incidence of donor-derived dis- Donor candidates should be informed that having 2
ease transmission according to cancer type, clinical features APOL1 risk alleles increases the lifetime risk of kidney fail-
and duration since treatment, through improved monitoring ure but that the precise kidney failure risk for an affected in-
and reporting. Support and expand efforts such as the “Notify dividual after donation cannot currently be quantified.
Project,”349 a consortium of global experts who gather didac-
tic information on documented types of adverse outcomes in RATIONALE
transplantation to identify general principles for detection
and investigation. Goals of Evaluation
• Develop systematic monitoring of long-term donor and recip- Genetic kidney diseases include autosomal dominant poly-
ient outcomes in the case of kidney transplantation from living cystic kidney disease (ADPKD), APOL1-related kidney disease,
donors with small (T1a) renal cell carcinoma to better inform atypical hemolytic uremic syndrome (aHUS), Alport syndrome,
guidance for when donation and transplantation may or may
Fabry disease, familial focal segmental glomerulosclerosis (FSGS),
not be acceptable.
and autosomal dominant tubulointerstitial kidney disease
(ADTKD). A family history of a genetic kidney disease with an
CHAPTER 14: EVALUATION OF GENETIC autosomal recessive mode of inheritance (such as cystinosis or
KIDNEY DISEASE some forms of familial FSGS) is usually not a contraindication
The ERT search parameters did not identify evidence for living kidney donation, although long-term follow-up data
from eligible studies pertinent to the recommendations in are not available in the literature.
chapter 14 and therefore the following recommendations All donor candidates should be asked detailed questions
are “Not Graded.” about a possible family history of hereditary kidney disease,
Evaluation and all reasonable measures should be taken by health profes-
sionals caring for the intended recipient to determine the cause
14.1: Donor candidates should be asked about their family of kidney failure in the setting of possible hereditary kidney dis-
history of kidney disease, and when present, the type ease. With permission of the intended recipient, information
of disease, time of onset, and extra-renal manifestations about the intended recipient’s cause of kidney failure should
associated with the disease. be reviewed carefully by the donor evaluation team and shared
14.2: When the intended recipient is genetically related to the with the donor candidate if it could affect the decision to donate.
donor candidate, the cause of the intended recipient’s
Some donor candidates have a family history of genetic
kidney failure should be determined whenever possible.
The intended recipient should consent to share this kidney disease.350 Some of these diseases first manifest later
medical information with the donor evaluation team, in life and are not identified when donor evaluation occurs
and with the donor candidate if it could affect the deci- at a younger age. Donation could increase the lifetime risk
sion to donate. of kidney failure in such a candidate. For this reason, it is im-
portant that transplant programs have a strategy for evaluat-
Selection ing for inherited kidney disease in donor candidates when
there is a family history of kidney failure and the recipient’s
14.3: Donor candidates found to have a genetic kidney dis-
ease that can cause kidney failure should not donate. cause of kidney failure is uncertain.
Many of the standard tests done as part of the donor eval-
uation should be interpreted with special consideration in the
Counseling setting of a family history of genetic kidney disease. Examples
14.4: Donor candidates must provide informed consent for ge- include renal imaging in the setting of family history of
netic testing if indicated as part of their evaluation. Do- ADPKD, or hematuria testing in the setting of a family his-
nor candidates should be informed of the possible effects tory of Alport syndrome (see also chapter 7).
of receiving a diagnosis of a genetic kidney disease, such Ideally, the estimation of long-term postdonation risk in a
as any impact on their ability to obtain health or life donor candidate should account for their family history of
insurance. genetic kidney disease, but there are currently no tools that
14.5: In cases where it remains uncertain whether the donor incorporate family history of genetic kidney disease with a
candidate has a genetic kidney disease and whether donor candidate’s other demographic and health characteristics
the disease can cause kidney failure, donation should to estimate long-term risk. Living donors who are biologically
proceed only after informing the donor candidate of
related versus unrelated to a recipient may have a higher inci-
the risks of donation if the disease manifests later in life.
dence of ESKD. In a large study from the United States, the
15-year cumulative incidence of ESKD was 0.34% in living do-
Autosomal Dominant Polycystic Kidney
nors who were biologically related to a recipient versus 0.15%
Disease (ADPKD)
in unrelated donors (a two-fold increase in relative terms, al-
14.6: Donor candidates with ADPKD should not donate. though difference was not statistically significant (P = 0.15).30
14.7: Donor candidates with a family history of ADPKD in a Donor candidates must provide informed consent to have
first-degree relative may be acceptable for donation if genetic testing if indicated as part of their evaluation. Donor
C.Agnello SE 0294
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 298 of 569 PageID #:
S76 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 492 www.transplantjournal.com
candidates should be informed of the possible effects of re- African descent may be genetically mediated or accelerated by
ceiving a diagnosis of a genetic kidney disease, such as any ef- coding variants in the APOL1 gene. Having at least one
fects on their ability to obtain health or life insurance. In cases APOL1 risk allele confers resistance to lethal Trypanosoma
where despite a normal evaluation at the time of donor can- brucei infections, and these variant alleles are observed in popu-
didate evaluation it remains uncertain whether the candidate lations of African descent but essentially absent among white
has a genetic kidney disease, donation should proceed only persons. Regionally, APOL1 risk variants are common in per-
after a full discussion with the donor candidate of the risks sons from West Africa and South Africa (sub-Saharan African
of donation if the disease manifests later in life. descent), and uncommon in North Africa. Approximately
With advances in genetic medicine and the implications of 13% of African Americans carry 2 APOL1 risk alleles.358
new risk alleles such as APOL1, there is likely to be rapidly Among African Americans in the general population, carrying
evolving knowledge that may influence future donor candi- 2 APOL1 risk alleles has been associated with FSGS359 and
date evaluations. However, at this time the testing for several HIV-associated nephropathy histopathologies, proteinuria,
genetic conditions is imperfect. This uncertainty should reduced GFR, younger age at dialysis and more rapid
prompt a discussion with all relevant stakeholders to achieve progression of kidney disease.235-238 The presence of 2 APOL1
consensus on proceeding with donation or not. risk alleles in a deceased donor associates with 2-to-4-times
higher RR of graft loss in the recipient, compared with
Autosomal Dominant Polycystic Kidney 0 or 1 risk alleles.360,361 Case reports of possible APOL1-
Disease (ADPKD) mediated adverse donor and recipient outcomes after
Recent studies and a KDIGO Controversies Conference living kidney donation among siblings of African ancestry
summarize diagnostic criteria for ADPKD.351,352 Simple were recently described.359,362
cysts occur more frequently with increasing age in the general Routine use of APOL1 genotyping and related counsel-
population. Kidney disease from PKD2 presents later in life ing within evaluation protocols has been advocated by
than PKD1. Age-dependent imaging criteria for diagnosis some,358,363-365 while others raise concerns.366 The utility
and disease exclusion have been established for at-risk adults of APOL1 testing has not been addressed in prior living do-
with unknown ADPKD gene type (PKD1 or PKD2).353 For nor guidelines. The impact of APOL1 screening on donor
example, for candidates 40 years or older with a first degree candidate exclusion, and the impact of test results on
relative with ADPKD, the finding of normal kidneys or a sin- postdonation outcomes and graft outcomes in living donor
gle cyst seen in one kidney with no cysts seen in the other kid- transplant recipients are yet to be defined.367 Nevertheless,
ney reliably rules out the presence of ADPKD.354 However, given APOL1-related risks identified in the general popu-
the utility of ultrasound to rule out ADPKD in younger do- lation and among deceased donor transplant recipients, as
nor candidates is more limited, where an absent or limited well as known higher risk of renal complications among
number of cysts on CT or MRI can be considered to rule African American compared with white donors,368 we
out ADPKD.352 DNA testing can also sometimes help diag- recommend considering APOL1 genotyping in donor can-
nose or exclude the condition.355 Linkage-based genetic diag- didates with sub-Saharan African ancestors. The implica-
noses of ADPKD using polymorphic markers flanking the tions of having 2 APOL1 risk alleles likely differ in younger
2 disease genes is now rarely performed. Rather, direct muta- versus older donor candidates, and whether the genetically re-
tion screening (by Sanger or next-generation sequencing) is lated intended recipient has the same alleles. The implications
now commonly used for molecular diagnosis of ADPKD.356,357 of having 2 APOL1 risk alleles may also be influenced by the
Up to 15% of patients with suspected ADPKD have a nega- results of kidney function testing done at the time of donor
tive comprehensive mutation screen. The first-degree relative candidate evaluation.
with ADPKD should undergo PKD1 and PKD2 mutation A 2016 AST Expert Conference opined that pending more
screening (using an acceptable technique), and if a patho- evidence, at this time all African American living donor can-
genic mutation is successfully identified, the donor candidate didates should be informed about the associations of APOL1
can be tested for this same mutation. However, when muta- risk alleles with CKD/ESKD risk in the general population
tion screening in the first-degree relative with ADPKD is nega- and offer genetic testing as part of the evaluation (including
tive, DNA testing including molecular diagnostics is unhelpful coverage of testing costs) to candidates who wish to know
in determining whether the donor candidate does or does not their APOL1 status.369 The WG also recommended counsel-
have ADPKD. ing donor candidates that precise ESKD risk for an affected
The criteria to diagnose ADPKD in patients with no family individual cannot currently be quantified, and that genetic
history of ADPKD is less certain (a family history is absent in testing may post psychological stress. Finally, the authors
10-15% of patients with ADPKD). A patient with bilaterally advised that use of APOL1 risk allele status should be inte-
enlarged kidneys with innumerable cysts most likely has grated with the donor candidate’s full profile of demo-
ADPKD, although the presence of other cystic kidney dis- graphic and health characteristics in determining donor
eases should also be considered.351 candidacy.
Apolipoprotein L1 (APOL1) Risk Alleles Alport Syndrome (See also Chapter 7)
The use of APOL1 genotyping in the donor evaluation is Alport syndrome is a genetic disease that alters collagen
currently grounded primarily in evidence extrapolated from biosynthesis. Collagen is an important structural component
nondonor populations. Recent literature supports that at of the basement membranes in the kidney, inner ear and eye,
least a portion of kidney failure previously attributed to hy- and the clinical manifestations of Alport syndrome include
pertensive nephrosclerosis or other diseases (eg, FSGS, lupus persistent microscopic hematuria, early onset bilateral senso-
nephritis, HIV nephropathy, sickle cell disease) in persons of rineural hearing loss, and ocular anterior lenticonus and
C.Agnello SE 0295
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 299 of 569 PageID S77
KDIGO Living Kidney Donor Work Group
#:
493
retinal flecks. The combination of a detailed family history clinical course with variable clinical manifestations owing
assessment and a kidney biopsy helps establish the diagnosis, to random X chromosome inactivation. Renal manifesta-
where electron microscopy demonstrates areas of irregular tions include microscopic hematuria and the presence of
glomerular basement membrane thickness with lamellation, white blood cells in the urine; less than 1% of heterozygous
splitting and sometimes characteristic “basket-weave appear- females develop kidney failure in their lifetime. A presump-
ances.”370 The presence of Alport syndrome can be con- tive clinical diagnosis of Fabry disease can be made on the
firmed by genetic testing, and next-generation sequence basis of a family history and signs and symptoms, with con-
panels provide opportunities to genetically screen for colla- firmatory testing for deficient α-galactosidase A enzyme ac-
gen mutations.371 Alport syndrome is primarily an X-linked tivity in plasma and leukocytes (this deficiency is evident in
disorder (approximately 80% of families), but can also be males with the disease), and genetic testing.377
inherited in an autosomal recessive (approximately 15% of There is very little information on the outcomes of hetero-
families) and autosomal dominant fashion (very rare).372,373 zygous females with Fabry disease who proceeded with
Most women who are heterozygotes for X-linked Alport syn- kidney donation.378 As with heterozygous Alport syndrome
drome exhibit hematuria (95% of women in one European carriers, if donation is entertained, considerations should in-
cohort). Of note, collagen (COL4A) mutations are present clude the age of the woman and careful deliberation of all
in families with Alport syndrome (85% of Alport syndrome other treatment options for the intended recipient.
is caused by mutations of COL4A5), and are also present
in some families with familial FSGS, sporadic FSGS, and thin Familial Focal Segmental Glomerulosclerosis (FSGS)
basement membrane disease.374,375 Overall, the severity of In recent years, many inheritable genetic forms of FSGS
nephropathy in Alport syndrome is variable. Many males have been described, caused by mutations in a number of
with X-linked Alport syndrome will develop ESKD before genes for proteins that are important for podocyte function
the age of 40 years. Most female carriers of X-linked Alport or glomerular basement membrane assembly.374,379 FSGS
syndrome will not develop kidney failure in their lifetime al- can follow both recessive and dominant inheritance pat-
though cases of ESKD do occur.370,373 terns.380 Of note, other clinical terms are used to describe
There is little information on the outcomes of such hetero- the same or similar diseases based on age of onset or response
zygotes who proceeded with kidney donation (after confirm- to therapy (eg, congenital nephrotic syndrome, steroid resis-
ing the absence of proteinuria, hypertension, low GFR and tant nephrotic syndrome).381
other manifestations of the disease such as sensorineural There are case reports of individuals who have developed
hearing loss). Gross et al174 described 6 mothers with Alport FSGS, proteinuria and kidney failure after donating a kidney
syndrome (across several European centers) who donated to a sibling with kidney failure from FSGS.382 The role of ge-
kidneys to their children with the disease. Five mothers with netic testing in relatives with a family history of kidney failure
X-linked Alport syndrome donated to their sons and one from FSGS is yet to be determined.
mother who was a carrier of autosomal recessive Alport syn-
drome donated to her daughter; kidney function declined Atypical Hemolytic Uremic Syndrome (aHUS)
25% to 60% in 4 of the 6 donors over the observed 2 to There are case reports of individuals who donated a kid-
14 years after nephrectomy, although no donor's creatinine ney to a relative with kidney failure from Atypical Hemolytic
clearance was less than 40 mL/min at the time of follow-up Uremic Syndrome (aHUS), where the donor developed aHUS
evaluation; 4 of the 6 developed microalbuminuria or pro- in the year after donation.383 A high chance of graft failure
teinuria, and hypertension was diagnosed in 4 of 6 donors. from aHUS reoccurrence in the recipient has also been de-
There are often several considerations in evaluating a mother scribed (>80% with some aHUS mutations). Current genetic
with X-linked Alport syndrome for donation to a son with testing is imperfect in excluding the presence of aHUS in a do-
kidney failure, including her desire to care for her child and nor candidate even when the mutation is known in the recip-
the possible guilt associated with passing on a genetic kid- ient. For these reasons some suggest never to proceed with
ney disease.376 Alternative treatment options should be living kidney donation in the setting of a related recipient
considered (including other living donors), as should the with aHUS. Others suggest assessing whether a donor candi-
age of the woman (older women have had more time to date shares a genetic susceptibility factor to aHUS to deter-
manifest kidney disease, so normal testing at the time of mine whether or not they may be an acceptable donor.384
their evaluation is more reassuring than similar results in
a younger woman). Autosomal Dominant Tubulointerstitial Kidney
Disease (ADTKD)
Fabry Disease ADTKD is a heterogeneous genetic disorder. Individual
Fabry disease is an X-linked lysosomal storage disease families may have a large number of affected individuals.
caused by deficiency of the lysosomal hydrolase, α- Mutations in at least 4 genes are implicated: MUC1 gene
galactosidase A (α-Gal A), which results in systemic accumu- which encodes mucin 1 (MCKD1), REN gene which encodes
lation of trihexosylceramide (globotriaosylceramide [GL-3]) renin, UMOD gene which encodes uromodulin (MCKD2)
in the lysosomes of the vascular endothelium in multiple and the HNF1B gene which encodes hepatocyte nuclear
organs. Clinical features include neuropathic pain and factor-1β.385,386 Similar to other autosomal dominant dis-
angiokeratoma, proteinuria, CKD, left ventricular hypertro- eases, there is 50% probability that each child will inherit
phy, arrhythmia and stroke. Symptoms generally appear in the disease from their affected parent. Both HNF1B and
childhood, although some go unrecognized until adulthood. MUC1 mutations can arise de novo without a prior family
Many affected males develop ESKD by the time they are 35 history of disease. Donor candidates may be offered target
to 45 years of age. Heterozygous females have a different mutation screening to assess whether the disease is present,
C.Agnello SE 0296
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 300 of 569 PageID #:
S78 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 494 www.transplantjournal.com
if they are biologically related to a patient with kidney failure • Better define the implications of sickle cell trait on long-term
who has evidence of the pathogenic mutation. kidney function and implications for donor selection.
Sickle Cell Trait CHAPTER 15: PREGNANCY
Approximately 8% of black Americans have sickle trait, Except in the case of Recommendation 15.9, the ERT
and the trait is also common among patients with Mediterra- search parameters did not identify evidence from eligible
nean or Indian subcontinent heritage.387,388 Many affected studies pertinent to the recommendations in chapter 15 and
persons may be unaware that they carry the trait. The preva- therefore the following recommendations are “Not Graded.”
lence of sickle trait among potential and actual kidney donors
is not known. Renal abnormalities in the presence of sickle Evaluation
cell trait range from isosthenuria to hematuria, to rare pre-
sentations with acute kidney injury in the context of severe 15.1: Female donor candidates should be asked about future
physical stress, such as military training or pregnancy.389 childbearing plans.
The manifestations of sickle cell trait depend on the individ- 15.2: Female donor candidates should be asked about prior
ual’s overall hemoglobin genotype and exposure to environ- hypertensive disorders of pregnancy (eg, gestational hy-
mental stressors.389,390 An increased incidence of medullary pertension, preeclampsia, or eclampsia).
15.3: Local guidelines should be followed to confirm the ab-
renal carcinoma has also been reported among persons with
sence of pregnancy before performing radiologic tests,
sickle cell trait. A prior survey of US transplant programs including abdominal computed tomography (with io-
(2005, 54% response rate) demonstrated substantial varia- dinated contrast) or nuclear medicine GFR testing.
tion in screening and exclusion practices, such that 83%
(113/137) of responding programs did not have a policy to
screen donors for sickle cell trait.391 Among the programs Selection
reporting related exclusion practices, 18% (19/105) reported 15.4: Women should not donate while pregnant.
always excluding donor candidates with sickle cell trait 15.5: Women should not be excluded from donation solely
whereas 16% (17/105) indicated they never exclude. because they desire to conceive children after donation.
15.6: Women with a prior hypertensive disorder of preg-
What Prior Guidelines Recommend nancy may be acceptable for donation if their long-
Prior guidelines and policies for the practice of living kid- term postdonation risks are acceptable.
ney donation discuss genetic considerations in the evaluation, 15.7: A decision to proceed with donation in the year after
although not to the extent presented in the current guideline. childbirth should consider the psychological needs of
Current OPTN policy requires that US transplant programs mother and child, and should include anesthesia and
establish and follow a protocol for screening for ADPKD analgesia planning for nursing mothers.
and other inherited kidney diseases as guided by family his-
tory.51 Several guidelines including those from the British Counseling
Transplantation Society describe imaging criteria used to ex-
clude the presence of ADPKD.48 15.8: Women with childbearing potential should be informed
of the need to avoid becoming pregnant from the time of
approval for donation to the time of recovery after ne-
RESEARCH RECOMMENDATIONS phrectomy; a quantitative human chorionic gonadotro-
pin (β-hCG) pregnancy test should be performed and
• Determine how a genetic predisposition to various kidney dis- confirmed as negative immediately before donation.
eases relates to outcomes after donation. Use genetic information 15.9: We suggest that women with childbearing potential be
along with other candidate characteristics to estimate the long- counseled about the effects donation may have on fu-
term risk of ESKD in the absence and presence of donation.7 ture pregnancies, including the possibility of a greater
• Develop better strategies and tools to screen donor candidates for likelihood of being diagnosed with gestational hyper-
genetic kidney diseases that consider the accuracy, efficiency and tension or preeclampsia. (2C)
costs of testing, including assessment of targeted gene panels for 15.10: Women with a prior hypertensive disorder of pregnancy
known mutations implicated in kidney diseases.392 should be informed about their long-term risks.
• Develop reliable imaging criteria to exclude ADPKD in donor 15.11: Women with childbearing potential who proceed with
candidates based on the results of the CT angiogram, which is donation should be counseled on how to reduce the risk
frequently used to assess the renal vasculature as a routine of complications in future pregnancies.
part of the donor evaluation.
• Define the role APOL1 genotyping in the evaluation of donor
candidates of sub-Saharan African ancestry.369 Acquire ade- RATIONALE
quate data to assess rare outcomes such as ESKD in donors
Evaluation and Selection
from national registries incorporating biospecimens and
long-term outcomes information. Female donor candidates should be asked about their fu-
ture childbearing plans and potential, which is determined
◯ For example, in December 2016 the NIH announced 2 re- by the candidate’s age, history of menopause, and any prior
quests for applications to form the APOL1 Long-term
history of sterilization. This information has implications
Kidney Transplantation Outcomes (APOLLO) Network
consortium directed at designing and conducting multi- for counseling and the need to confirm the absence of preg-
center, prospective, longitudinal studies to determine the nancy at the time of donor nephrectomy.
impact of APOL1 genetic variants on outcomes after liv- When evaluating donor candidates, knowledge about a
ing kidney donation/transplantation and deceased donor prior history of hypertensive disorder during pregnancy and
kidney transplantation.393,394 its severity is important, as when such a history is present
C.Agnello SE 0297
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 301 of 569 PageID S79
KDIGO Living Kidney Donor Work Group
#:
495
(vs absent) it is associated with a higher risk of ESKD.395 One With regard to prior guidelines, the 2004 Amsterdam Fo-
meta-analysis concluded that women were at greater risk of rum concluded that donor nephrectomy is not detrimental
albuminuria after a preeclamptic pregnancy compared with to the prenatal course or outcome of future pregnancies. At
a normal pregnancy (5- to 10-year incidence of 31% vs the time, the participants concluded there were no data to
7%).396 This meta-analysis was, however, restricted by small suggest that hyperfiltration associated with the combination
studies of variable quality that focused often on women with of unilateral nephrectomy and pregnancy leads to significant
severe preeclampsia or underlying diseases such as diabetes hypertension, proteinuria, change in GFR, or abnormalities
mellitus. A population-based study from Norway suggested of the urinary sediment.38 Some transplant programs have
that women were at greater risk of ESKD if they developed historically not disclosed any potential postdonation preg-
preeclampsia during pregnancy than if they did not (approx- nancy risks as part of the informed consent process. How-
imate 30-year cumulative incidence after a woman’s first ever, 3 recent studies provided new information on this
pregnancy of 0.4% vs 0.1%)397 The risk remained evident risk. Two retrospective cohort studies, one from the United
after excluding women with a prepregnancy history of States and the other from Norway, reported an increased risk
known kidney disease, diabetes or hypertension. A study of gestational hypertension and preeclampsia after kidney
from Taiwan also described a greater risk of ESKD in preg- donation, based on comparisons of pregnancies before and
nant women who developed a hypertensive disorder during after donation within donors (Evidence Report Table 21,
pregnancy compared with a normal pregnancy (approximate SDC, http://links.lww.com/TP/B434, and Supplemental Appen-
12-year cumulative incidence after pregnancy of 0.6% vs < dix Table D18, SDC, http://links.lww.com/TP/B432).402,403
0.1%)398 In general, characteristics associated with a lower Another recent retrospective cohort study from Canada dem-
long-term risk of ESKD after a history of hypertension in preg- onstrated gestational hypertension or preeclampsia was
nancy include: i) a mild (vs severe) hypertensive event during more likely to be diagnosed in kidney donors than matched
pregnancy; ii) more than 10 years since last hypertension event nondonors with similar indicators of baseline health
in pregnancy; iii) no evidence of hypertension, albuminuria or (11% vs 5%).401 The 2 groups did not differ significantly
low GFR in the current donor evaluation; and iv) no wish for with respect to other maternal or fetal outcomes (Caesar-
future pregnancies. ean section, postpartum hemorrhage, preterm birth with ges-
Gestational diabetes is a strong risk factor for subsequent tation less than 37 weeks, low birth weight < 2500 g), and
diabetes mellitus. A history of gestational diabetes mellitus there were no maternal deaths, stillbirths, or neonatal deaths
is also associated with a higher risk of ESKD.399 For recom- in either group (however, the CIs for the estimates were wide,
mendations related to gestational diabetes see Recommen- meaning that a clinically important risk among donors was
dations 11.5 and 11.7. not excluded). Most women in these cohorts were white
Because a fetus may be harmed by radiation and/or or (Table 22).
radiocontrast, local guidelines should be followed to confirm
the absence of pregnancy before performing certain tests as Counseling
part of the donor candidate evaluation, such as an abdominal Based on the new information, our guideline suggests that
CT (with iodinated contrast) or a nuclear GFR test. Some women who are capable of conceiving children after dona-
guidelines suggest that it may be reasonable to proceed with- tion be counseled about the possible impact donation may
out a quantitative human chorionic gonadotropin (β-hCG) have on future pregnancies. This suggestion agrees with a
pregnancy test if a woman’s menstrual period is not overdue 2015 AST Live Donor Community of Practice consensus
and there is an absence of pregnancy symptoms.400 conference conclusion that information on postdonation
A woman should not donate while pregnant. Women pregnancy risk should be shared in the informed consent pro-
with childbearing potential should be informed about the cess for donor candidates with reproductive potential.148 Be-
need to avoid becoming pregnant from the time she is approved ginning in 2017, OPTN Informed Consent Policy requires
for donation to the time she has recovered after nephrectomy. that US transplant programs inform donor candidates that
Approximately 1% of patients develop postoperative venous the risks of preeclampsia or gestational hypertension are in-
thromboembolism after donor nephrectomy and the risk of creased in pregnancies after donation.51 The ERT found the
using estrogen-based oral contraceptive medications before sur- evidence for a higher likelihood of being diagnosed with ges-
gery should be balanced against harms. Barrier birth control tational hypertension or preeclampsia after donation to be
can be an appropriate option in the weeks before surgery. consistent across the 3 studies, but of low quality.3
Women with childbearing potential should be supported Women with childbearing potential who proceed with do-
by transplant programs to make a well-informed donation nation should be educated on recommended evidence-based
decision. Transplant programs should enable donation when methods to reduce the risk of complications in postdonation
they estimate a candidate’s long-term postdonation risks are pregnancies. For example, in the nondonor population, sev-
acceptable. In other words, motivated well-informed women eral dietary and lifestyle interventions including interventions
should not be excluded from donation solely on the basis of a to reduce or prevent obesity have the potential to reduce the
desire to conceive children after donation. Most women with risk of preeclampsia.404,405
access to recommended pregnancy care have good maternal
and fetal outcomes in their postdonation pregnancies.401 We
advocate that recommended postdonation pregnancy care be RESEARCH RECOMMENDATIONS
available to all women worldwide, including any treatments • Investigate the precision of estimated, individualized preg-
needed for pregnancy complications. A decision to proceed nancy outcomes among donors through expanded monitoring
with donation in the year after delivery should carefully con- and reporting, including capture of more detailed clinical infor-
sider the needs of the mother and her baby. mation such as BP and kidney function.
C.Agnello SE 0298
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 302 of 569 PageID #:
S80 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 496 www.transplantjournal.com
TABLE 22.
Donor characteristics and maternal and fetal outcomes in postdonation pregnancies from 3 studies: Norway, Minnesota (United
States), and Ontario (Canada)
Norway Minnesota, United States Ontario, Canada
Donor characteristics
No. women 69 239 85
Years of donation 1967 to 2002 1963 to 2007 1992 to 2009
Family history of kidney failure (%) NR 96% 65%
Mean predonation GFR, mL/min per 1.73 m2 NR 91 114
White race (%) 98% 97% 70%
Number of postdonation pregnancies 106 490 131
Mean age at donation, y 27 26 29
Mean age at pregnancy, y 32 29 32
No. women with at least one predonation pregnancy (%) NR 98 (41%) 25 (29%)
Mean or median time from donation to postdonation pregnancies, y 5 5 4
Outcomes after donation
Postdonation maternal outcomes
Gestational hypertension or preeclampsia 9/106 (8%) 55/490 (11%) 15/131 (11%)
Gestational hypertension 3/106 (3%) 28/490 (6%) 7/131 (5%)
Preeclampsia 6/106 (6%) 27/490 (6%) 8/131 (6%)
Maternal death NR NR 0
Postdonation fetal outcomes
Preterm birth (<37 wk gestation) 10/106 (9%) 35/490 (7%) 10/131 (8%)
Low birth weight (<2500 g) 9/106 (8%) NR 8/131 (6%)
Stillbirth 3/106 (3%) 2/490 (<1%) 0
Neonatal death (<28 days after birth) 0 (0.0%) NR 0
GFR, glomerular filtration rate; NR, not reported. Modified with permission from Garg AX et al.401
◯ Develop individualized estimates for women who differ in 16.3: Whenever possible, the psychosocial evaluation of the
race/ethnicity, family history of kidney disease, and their donor candidate should be performed by health pro-
healthcare system. fessionals not involved in the care of the intended
• Determine whether the risks of complications in postdonation recipient.
pregnancies vary according to the side of nephrectomy. Preg- 16.4: Transplant programs should follow protocols for assessing
nancy may be associated with ureteral obstruction and dila- the donor candidate’s psychosocial suitability, available
tion, particularly of the right kidney.37,406,407 support, preparation and concerns for donation.
• Define the clinical sequelae of gestational hypertension and Selection
preeclampsia that develop in postdonation pregnancies,
including effects on long-term kidney outcomes. 16.5: Transplant programs should follow protocols defining
• Explore perceptions of pregnancy risk information by women psychosocial factors that either exclude donation, or
with different characteristics to improve education, counsel- prevent further evaluation until resolution.
ing, and informed consent processes.
Disclosures and Support
16.6: We suggest that donor candidates be informed that do-
CHAPTER 16: PSYCHOSOCIAL EVALUATION nors usually have good quality of life after donation (2D).
Except in the case of Recommendation 16.7, the ERT 16.7: Transplant programs should assist donor candidates and
search parameters did not identify evidence from eligible donors in receiving psychosocial or psychiatric support
studies pertinent to the recommendations in chapter 16 as needed.
and therefore the following recommendations are “Not
Graded.” RATIONALE
Evaluation Evaluation
The psychosocial evaluation of the living kidney donor
16.1: Donor candidates should receive in-person psychosocial candidate serves many functions. This evaluation helps deter-
evaluation, education and planning from health profes- mine if a candidate is psychologically fit for donation, for ex-
sionals experienced in the psychosocial concerns of do-
ample, by assessing if the donor candidate’s motivations are
nor candidates and donors.
16.2: To ensure voluntariness, at least a portion of the psycho- appropriate and identifying psychosocial risk factors for
social evaluation of the donor candidate should be per- poor outcomes. The evaluation also helps address any donor
formed in the absence of the intended recipient, family candidate concerns, and ensures potential psychosocial risks
members and other persons who could influence the do- and benefits of kidney donation are disclosed and under-
nation decision. stood. The psychosocial evaluation can also be used to
C.Agnello SE 0299
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 303 of 569 PageID S81
KDIGO Living Kidney Donor Work Group
#:
497
develop a tailored plan to support the donor candidate in In What Setting Should the Evaluation Be Performed?
having a positive psychosocial experience throughout the While the initial screening may be performed by telephone,
evaluation and donation processes. We recommend that particularly for donor candidates living far from the trans-
all donor candidates, irrespective of their relationship plant center, the main psychosocial evaluation should be
with the intended recipient, should be evaluated using conducted as a face-to-face interview, as has also been recom-
uniform criteria. mended in several prior reports.408 Third parties should
A recent systematic review of living kidney and liver donor not be present during at least a portion of the interview, to
candidates summarized 34 publications (guidelines, consen- maintain confidentiality and minimize the effect of ex-
sus statements and transplant program clinical protocols) ternal influences on the donor candidate’s responses. This
on the content of the psychosocial evaluation (including the suggestion is consistent with some prior reports.408 In other
elements to be considered and acceptance criteria) and the reports the presence of a relative or significant other during
process of the psychosocial evaluation (including who should a portion of the interview (as long as they are not the
be evaluated, how the evaluation should be performed, and intended recipient) is cited as potentially beneficial to the do-
the timing of the evaluation).408 The authors concluded that, nor candidate and the assessment process, in that such partic-
at present, there is little good evidence, concrete guidance or ipation may promote reliability of the information reported
consensus on what to screen for, how to handle psychosocial and provide information about support the donor candidate
problems, or how to perform the psychosocial evaluation. will need during the donation and recovery periods.408
These findings confirmed that there is substantial practice
variation in regard to psychosocial evaluations. The authors
concluded that, consistent with prior systematic reviews,20 Who Should Perform the Psychosocial Evaluation?
most recommendations in prior publications are based on ex- Our recommendations are similar to many prior guidelines
pert opinions (via consensus conference) and individual and national policies that recommend performance of the
transplant program experiences. The ERT assessed evidence psychosocial evaluation by various healthcare professionals
related to psychosocial outcomes after donation. (eg, psychiatrist, psychologist, clinical social worker, or a
psychiatric nurse) who meet qualifications of appropriate
training, knowledge and skill in mental health and the psy-
Should all Donors have a Psychosocial Evaluation? chosocial concerns of transplantation.51,54 As with prior rec-
Our recommendations are consistent with several prior ommendations we suggest that the psychosocial evaluation
guidelines and policies in some countries, which indicate that should be performed by an individual who is not involved
psychosocial assessment is a necessary part of the evaluation in the care of the intended recipient to reduce conflicts of in-
of each donor candidate.38,48,50,51,54,55,409 terest in evaluating the donor candidate.50
TABLE 23.
Recommended processes and content of the psychosocial evaluation
Process Content element
Assessment of suitability and preparation The following should be assessed in each donor candidate:
• Motivation for donation
• Expectations of the outcomes of donation, including impacts on their future relationship
with the recipient. The donor candidate should be counseled if these expectations appear to be unrealistic.
• History of current or past psychiatric disorders
• History of current or past substance abuse or dependence (eg, use of alcohol, illicit drugs or prescription drugs)
• Support system, including available family, friends and workplace supports, and coping strategies
(including available programs) to minimize any negative impacts from donation
• Preparation for the possible medical impact of donation, and any expected impact on their activities
after donation
• Preparation for the possible emotional impacts of donation (both positive and negative)
• Preparation for the possible financial impacts of donation, including potential impact on employment status
and wages, expenses for medical care, travel and dependent care, and any effects on insurability or rates
• Understanding and acceptance of their responsibility for making good health choices after donation,
including the need to organize and adhere to recommended routine medical follow-up
• Behaviors that increase the risk of a donor transmitting an infectious disease to the recipient
Education • The process and requirements of informed consent should be reviewed (see chapter 2 of this guideline for
complete details)
• Concerns about medical, emotional and financial impacts of donation should be elicited and addressed with
appropriate education and/or referral to a knowledgeable member of the transplant team
• Donor candidates can be told that most prior donors have experienced good psychosocial outcomes,
although some people experience psychosocial difficulties after donation
Planning and support • An individualized plan to support the donor candidate in having a positive psychosocial experience throughout
the evaluation and donation processes should be developed for each candidate, guided by donor candidate
concerns and psychosocial risk factors that can be managed without excluding donation
C.Agnello SE 0300
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 304 of 569 PageID #:
S82 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 498 www.transplantjournal.com
Protocols for Assessing the Donor Candidate’s residual ambivalence about donation (ie, no lingering hesita-
Psychosocial Suitability tion or uncertainty), more education, an absence of
It is important for transplant programs to follow pre- predonation psychiatric diagnoses, an absence of feeling mor-
determined protocols in evaluating each donor candidate’s ally obligated to donate, more social support, lower
psychosocial suitability equitably. The protocol should include predonation expectations of health consequences after dona-
a comprehensive list of the processes and content of the psy- tion, less financial burden, and the feeling of having received
chosocial evaluation (Table 23). Recommended components adequate attention from the transplant team.415-419 A system-
of the psychosocial evaluation specified in prior guidelines atic review of prospective studies of postdonation health-
include mental health history,47,48,51,54,196,409 substance use related quality-of-life (HRQoL) published after completion
history,47,48,51,54,409 understanding of risks,47,51,55 ability to of the ERT's systematic review for this guideline found that,
make an informed choice,51 coping capacity,47,51,409 social among 9 studies examining risk factors for impaired HRQoL,
support,47,48,51,409 risk factors for poor psychosocial low psychological functioning before donation was the most
outcomes (details unspecified),51,409 motivation and common predictor.420
voluntariness,47,51,409 and donor-recipient relationship.47,48
What Psychosocial Criteria Should Exclude Donation?
Considerations for Nondirected Donor Candidates Psychosocial elements that should be reviewed with the
Practice patterns related to the psychosocial evaluation of donor candidate and the psychosocial criteria that either ex-
nondirected donors vary considerably worldwide.410-412 clude donation, or prevent further evaluation of the donor
Our opinion is that candidacy criteria should be similar candidate until the issue is resolved, are summarized in
whether an individual is being assessed for directed or nondi- Table 24. Donation should not occur when there is evidence
rected donation, recognizing that some elements of the in- of, or expectation of, unreasonable secondary gain. The Dec-
formed consent may vary, including those related to how laration of Istanbul endorses measures to protect individuals
the intended recipient is selected, time frames for donation, from the unregulated sale of organs.421 At least 18 prior re-
travel requirements, and opportunities or prohibitions about ports have described relative and absolute psychosocial con-
contact with the recipient after donation and transplant. traindications to donation.408
Selection Disclosures and Support
Which Predonation Characteristics are Associated What Should Donor Candidates be told about their
with a Greater Chance of Poor Psychosocial Outcomes Likely Psychosocial Outcomes after Donation?
after Donation? The psychosocial evaluation provides an opportunity to
The ERT identified 2 studies examining whether the asso- share what emotions the donor candidate might experience
ciation between donation (donors vs healthy nondonors) and after donation, and the anticipated short- and long-term psy-
long-term psychological outcomes were modified by an individ- chosocial outcomes after donation.
ual’s baseline characteristics (Evidence Report Tables 9 and 11, Kidney donation has a profound and multifaceted impact
SDC, http://links.lww.com/TP/B434; Supplemental Appendix on the lives of many donors and influences their identity,
Tables D6 and D8, SDC, http://links.lww.com/TP/B432). The roles and relationships. Two recent systematic reviews
quality of this evidence was graded as very low. In one study summarize qualitative data about donor experiences after
the association between donation (donors vs nondonors) and donation.422,423 On average, donors experienced increased
long-term mental quality of life score was not modified by self-esteem, empowerment, and community awareness, but
age.413 In the other study, the cumulative incidence of re-
corded depression diagnoses was lower in donors compared
TABLE 24.
with matched beneficiaries in the same insurance system,
Recommendations for psychosocial factors that either
among both men and in women.414
exclude donation, or prevent further evaluation
The ERT summarized the results of several studies wherein
until resolution
donors with a characteristic were compared to donors with-
out the characteristic, to see if the 2 groups differed on the Psychosocial contraindications to donation
chance of a poor psychosocial outcome. The quality of this
evidence was graded as low to very low. These results are • A wish not to donate or marked ambivalence about donating
challenging to interpret because: many studies reported dif- • Evidence of, or high suspicion of, undue pressure
ferent psychosocial outcomes that were not directly compara- • Evidence of, or high suspicion of, unreasonable or illegal secondary gain
ble; the effects were not always seen across all psychosocial (such as an unregulated financial transaction)
outcomes measured within a study; the results of characteris- • A failure to meet the requirements of informed consent (see chapter 2).
tics associated with outcomes were inconsistent across the This includes a donor candidate, who despite counseling, continues to have
studies; and the likelihood a donor with the characteristic unrealistic expectations about the donation experience or
would experience the outcome was often reported in relative potential outcomes
rather than absolute terms (see Evidence Report Tables 10, • Psychiatric conditions that can be treated to improve the donor candidate’s
predonation mental fitness and chance of a good postdonation outcome
12, 14, 15, 20, SDC, http://links.lww.com/TP/B434; Supple-
mental Appendix Tables D7, D9, D11, D12, D17, SDC, • Past or present substance use disorder
http://links.lww.com/TP/B432). • A psychosocial profile that predicts a level of postdonation risk that exceeds
a transplant program’s acceptable risk threshold. Such a profile may include
In some studies, predonation characteristics that were as-
sociated with reduced chance of poor psychosocial outcomes an active substance use disorder, or the absence of needed psychosocial
(ie, with a better psychosocial prognosis) included a lack of or financial support
C.Agnello SE 0301
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 305 of 569 PageID S83
KDIGO Living Kidney Donor Work Group
#:
499
some also described a lack of emotional support. A subse- What Should Donors Be Told About How Donation May
quent systematic review of 34 prospective studies of Impact Them Financially?
postdonation HRQoL (1990 to 2014) found that, after mild Donor candidates and living kidney donors incur personal
reductions early after nephrectomy, HRQoL returned to direct and indirect expenses as part of the evaluation and do-
baseline or was slightly reduced by 3 to 12 months, particu- nation processes, even in countries where the donor’s medical
larly for fatigue, but was still comparable with general popu- expenses are paid by the recipient’s insurance or the health-
lation norms.420 care system. Major costs include transportation, accommo-
In general, donors demonstrate good quality of life and dation, child care, lost income (or vacation time), and
have low rates of donation regret. That said, living donation missed time from work.426,427 In a prospective Canadian
is not without psychosocial risk, and some donors have expe- follow-up study, the mean cost associated with donation
rienced psychosocial difficulties after donation (eg, depression, was $3268 (Canadian dollars); however for 15% of donors,
anxiety, stress, worries about health), and such problems have costs exceeded $8000.428 The expenses incurred during the
impacted their functioning and ability to return to work. predonation evaluation are also described in another recent
One study was identified by the ERT that reported psycho- study from the United States.429 These findings have led to rec-
social outcomes in a group of donors compared with healthy ommendations that living donor candidates receive counseling
nondonors, and the evidence quality was graded as very low about financial costs before donation, and have fostered gov-
(Evidence Report Table 8, SDC, http://links.lww.com/TP/ ernmental and other programs in multiple countries to reim-
B434; Supplemental Appendix Table D5, SDC, http://links. burse donors for their legitimate expenses and attempt to
lww.com/TP/B432).413 In the reviewed multicenter study, av- maintain financial neutrality.430-432
erage values of 3 HRQoL scores among donors (a median of However, there are limitations to many current cost mit-
6 years after donation) were similar to a group of nondonors igation programs. In the United States, the National Living
and population norms. There was also no significant differ- Donor Assistance Center (NLDAC) (via a Health Re-
ence between the 2 groups in marital status, mental health sources and Services Administration grant) offers grants to
visits and psychotropic medication use. offset travel and lodging costs for living donors and an ac-
A report of 2455 living donors from 3 large US centers companying person during the evaluation, donation and
known as the Renal and Lung Living Donors Evaluation follow-up, but reimbursement eligibility is means tested
Study (RELIVE) cohort (93% white race, 72% biologically and is based on the incomes of both the living donor candi-
related to recipient) found that HRQoL scores in living date and recipient; further, nondirected donors have limited
donors in the decades after donation were similar or better access because they cannot provide recipient income infor-
than the US population.415 However, 9% of RELIVE study mation. In the United States, many states have enacted legis-
respondents reported one or more of the following poor psy- lation to offer tax deductions or credits, or other benefits, to
chosocial outcomes: “fair” or “poor” overall donor experi- living organ donors.433 These programs vary state by state,
ence, financial burden, regret or discomfort with decision to are underused, and have not been studied with regard to
donate, or psychological difficulties since donation.424 Recipi- impact on financial burden of donation. Several studies
ent graft failure was the only identified predictor of reporting have considered whether kidney donation affects one’s
one or more of these poor psychosocial outcomes, and was ability to obtain life, disability and health insurance.434-436
associated with 77% higher risk (OR, 1.331.772.34). Another These issues are country-specific, and should be considered
report of 4650 privately insured living kidney donors in the in donor candidate counseling and support.
United States described lower rates of depression diagnoses A 2016 convenience sample of informed consent forms for
after donation compared with rates among age- and sex- living donor and transplant candidate evaluation from 9 geo-
matched beneficiaries in the same insurance system.414 A sys- graphically diverse US programs identified misconceptions
tematic review published in 2006 summarized 51 studies de- about defraying donation-related costs, reinforced by ambig-
scribing 5139 donors who were assessed on average 4 years uous language or omissions in the donor informed consent
after donation.425 Most donors who participated in follow- documents.437 Donor candidates should receive clear, accu-
up reported no depression or anxiety, with questionnaire rate education on how to access available financial support
scores similar to the general population. The majority re- as well as the limitations of available resources. In 2016,
ported no change or an improved relationship with their re- the AST launched an online financial toolkit to help donor
cipient, spouse, family members and nonrecipient children. candidates learn about the finances of being a living organ
Some experienced an increase in self-esteem. A majority donor; this dynamic resource will be expanded and updated
expressed no change in their attractiveness. Most donors over time.438 Although developed from the perspective of
(96%) did not regret their donation decision. US-based policies and resources, the information may be
Based on these data, we suggest that donor candidates be helpful to donor candidates in other countries. See chapter
informed that in general, donors demonstrate good quality 18 for a discussion of policy related to financial support
of life after donation. However, donor candidates should and removal of economic disincentives to donation.
also be informed that some people experience psychosocial
difficulties after donation (eg, depression, anxiety, a negative How Should Transplant Programs Help Donor
change in their relationship with the recipient, more pain Candidates and Donors in Need of Psychosocial Support?
than expected, a recovery time that is slower than expected, Tailored plans to support each donor candidate in hav-
a decline in their vitality, unexpected expenses related to do- ing a positive psychosocial experience throughout the
nation recovery, anticipated benefits that were short-lived or evaluation and donation processes should be developed,
not met at all) or anxiety related to worries about their health guided by donor candidate concerns and psychosocial risk
(including a fear of kidney failure).78,425 factors that can be managed without excluding donation.
C.Agnello SE 0302
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 306 of 569 PageID #:
S84 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S500 www.transplantjournal.com
Candidates ultimately excluded from living donation for any anxiety disorder); iii) available social resources (eg, social
reason may experience feelings of emotional distress, disap- support, workplace support); and iv) information disclo-
pointment and guilt, frustration from inability to control sure, understanding and risk processing (eg, elements of in-
formed consent).447
one’s own body and health, and in the case of planned dona-
tion to a spouse or dependent, caregiver burden or ongoing • Determine which components of the psychosocial interview
impact of the intended recipient’s illness on the donor’s life- should be structured to cover relevant material while address-
ing the unique needs and questions of a given donor candidate.
style.75 The transplant program should assist excluded donor
• Perform clinical trials to compare evaluation approaches, ac-
candidates who have difficulty accepting their candidacy de- ceptance criteria, and interventions to minimize the risk of
cision in receiving needed psychosocial support or psychiat- poor postdonation psychological outcomes.
ric help.
In approximately 5% of living kidney donor transplants ◯ For example, in a recent randomized trial of 113 potential
kidney donors with some evidence of residual ambiva-
the recipient or their graft does not survive the first year. Un-
lence to donation, it was suggested that motivational in-
derstandably, poor recipient outcomes can be a source of terviews (vs additional health education or standard
stress and disappointment to the donor, and the transplant care) reduced ambivalence to donation, anxiety symptoms,
program should provide postdonation psychosocial support unexpected family-related problems, and the risk of negative
at such times. In some studies, but not others, poor recipient physical symptoms after donation.417
outcomes have been associated with poor psychosocial
outcomes in donors.413,414,439-443 In one study, most of CHAPTER 17: ACCEPTABLE SURGICAL APPROACHES
the adverse recipient events were beyond the first year FOR DONOR NEPHRECTOMY
posttransplant.414 Most donors will not experience poor Except in the case of Recommendations 17.3 and 17.7, the
short- or long-term medical or psychosocial outcomes after ERT search parameters did not identify evidence from eligible
donation, but for those who do, the transplant program studies pertinent to the recommendations in chapter 17 and
should participate to ensure that the donor receives psycho- therefore the following recommendations are “Not Graded.”
social support or psychiatric help. The responsibility to
ensure that donors receive psychological support when out- 17.1: Renal imaging (eg, computed tomographic angiography)
comes are poor is also described in a prior guideline.409 The should be performed in all donor candidates to assess re-
Declaration of Istanbul states that all donors should be nal anatomy before nephrectomy.
offered psychosocial services as a standard component of 17.2: The surgeon should have adequate training and experience
follow-up,421 and the CARI guideline recommends follow-up for the surgical approach used for the donor nephrectomy.
of the psychosocial impact of living kidney donation for every 17.3: We suggest that “mini-open” laparoscopy or hand-assisted
living donor during the first year after donation.409 Incomplete laparoscopy by trained surgeons should be offered as opti-
or inconsistent follow-up after the early postdonation period mal approaches to donor nephrectomy. However, in
may lead to under-recognition of donation-related psychoso- some circumstances, such as for donors with extensive
previous surgery and/or adhesions, and at centers where
cial problems in the longer-term. Models for the collection of
laparoscopy is not routinely performed, open nephrec-
long-term psychosocial outcomes after donation exist inter- tomy (flank or laparotomy) may be acceptable. (2D)
nationally, including the European Living Donation and 17.4: Robotic, single-port, and natural orifice transluminal nephrec-
Public Health (EULID) project, an 11-nation registry that tomy should generally not be used for donor nephrectomy.
uses an online tool for reporting follow-up information in- 17.5: Nontransfixing clips (eg, Weck Hem-o-lok) should not
cluded psychosocial and socioeconomic outcomes.444 The be used to ligate the renal artery in donor nephrectomy;
national Swiss Living Donor Health Registry (SOL-DHR) instead, renal artery transfixation by suture ligature or
follows donors lifelong and includes an 8-Item Short-Form anchor staple within the vessel wall should be used.
(SF-8) and social-status questionnaire.445 17.6: In the absence of reasons to procure the right kidney
(vascular, urological or other abnormalities), the left
kidney should be procured in laparoscopic donor ne-
RESEARCH RECOMMENDATIONS phrectomy because of the relative technical ease associ-
ated with a longer venous pedicle.
• Better define the optimal processes and content of the psycho- 17.7: We suggest laparoscopic procurement of the right rather
social evaluation. For example, there are emerging efforts to than the left living donor kidney may be performed if the
help standardize the psychosocial evaluation through the develop- surgeon has adequate training and experience. (2D)
ment of semi-structured evaluation tools.446 17.8: Procurement of a living donor kidney with 3 or more
arteries should only be undertaken by surgeons with
◯ Duerinckz et al,408 on behalf of the Ethical Legal Psycholog-
adequate experience.
ical Aspects of Transplantation Organization, summarized
17.9: A donor candidate with atherosclerotic renal artery dis-
surveys or tools used for psychometric testing in the donor
ease or fibromuscular dysplasia involving the orifices of
candidate evaluation from prior guidelines, consensus state-
both renal arteries should not donate.
ments and transplant program protocols such as mood ques-
tionnaires, personality interviews and drug abuse screening.
The type, number and content of tools described in prior
guidelines were variable. RATIONALE
◯ The same group also recently provided a conceptual frame- The choice of surgical approach and the organ for procure-
work for the key elements in the psychosocial evaluation ment (left vs right kidney) should take into consideration the
of living kidney donor candidates, including assessment of: experience of the surgeon as well as any renal functional, pa-
i) motivation (eg, coercion, ambivalence); ii) the presence renchymal, vascular or urological abnormalities. Relevant
of psychopathology (eg, cognitive disturbance, mood or outcomes to consider in comparing surgical approaches
C.Agnello SE 0303
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 307 of 569 PageID S85
KDIGO Living Kidney Donor Work Group
#:
501
include: mortality; perioperative complications (eg, bleeding, Warm Ischemia Time
reoperation, incisional hernias); quality of life, including pain Data regarding warm ischemia times with laparoscopic
and wound cosmesis; recovery time; and graft outcomes in versus open nephrectomy are conflicting. In 9 of the 11 pub-
the recipient. Studies often report operative time as a surro- lications evaluated by Fonouni et al,448 longer warm ischemia
gate measure for risks of anesthesia-related complications. times were reported in the laparoscopic nephrectomies com-
The ERT identified 4 recently published systematic reviews de- pared with open nephrectomies. Similarly, all included
scribing perioperative outcomes after living donor nephrec- studies in the review by Wilson et al450 found longer warm
tomy.448-450 ischemia times in the laparoscopic groups, with differences
ranging from 2 to 17 minutes. In contrast, based on data
from 15 trials including data for 1598 donors, Yuan et al
Laparoscopic versus Open Nephrectomy identified a small, significant decrease in warm ischemia
The ERT identified 3 systematic reviews comparing out- time with laparoscopic compared with open nephrectomy
comes after laparoscopic versus open nephrectomy448,450,451 (mean difference, −1.8 minutes; 95% CI, 1.3-2.2); warm
(Evidence Report Table 3, SDC, http://links.lww.com/TP/ ischemia time also trended lower for hand-assisted lapa-
B434; Supplemental Appendix Table C3, SDC, http://links. roscopy compared with open nephrectomy (mean differ-
lww.com/TP/B432). Collectively, these reviews provide very ence, 0.4 minutes; 95% CI, −0.2 to 1.0), but this
low to high quality evidence for several outcomes, including difference was not statistically significant. Overall, there
operative time, blood loss, warm ischemia time, reoperation, were no clinically important differences in warm ischemia
length of hospital stay, and return to work. Overall, laparo- times with laparoscopic versus open donor nephrectomies.
scopic and open donor nephrectomies have comparable out- Wilson et al450 found no significant differences between lap-
comes with regard to donor safety and graft function. Simple aroscopic and open nephrectomy for early graft loss (RR,
open (flank subcostal retroperitoneal) donor nephrectomy is 0.060.311.48;), delayed graft function (RR, 0.521.092.30), acute
generally performed with shorter operative times than lapa- rejection (RR, 0.871.412.27), ureteric complications (RR,
roscopic nephrectomy but may incur slightly higher blood 0.691.51 3.31;), donor kidney function at 1 year (standardized
loss. Open nephrectomy is no longer considered the standard mean difference, 0.15; 95% CI, 0.11 to 0.41) or graft loss
of care due to a longer incision and generally longer asso- at 1 year (RR, 0.150.763.85).
ciated hospital stay, higher analgesia requirements, and
longer convalescence period. By 2013, almost all living Reoperation
donor nephrectomies in the United States were performed
Fonouni et al448 included 7 publications (both trials and
laparoscopically, and, with increasing experience, few are
meta-analyses with unreported donor sample sizes) reporting
converted to open procedures.94 However, in unusual circum-
reoperation rates, and found mixed results. Although 4 of the
stances, such as for donors with extensive previous surgery
publications found no difference between the groups, 3
and/or adhesions, and at centers where laparoscopy is not rou-
found higher reoperation rates in the laparoscopic compared
tine, open nephrectomy (flank or laparotomy) may be justi-
with the open group. Based on data from 6 studies, Wilson
fied. Of note, as for most surgical procedures, experience is
et al450 found fewer reoperations with open nephrectomy
likely to be an important determinant of outcomes, and trials
compared with laparoscopic nephrectomy, but this difference
and observational series were generally performed at experi-
was not statistically different (RR, 0.090.573.64).
enced centers by limited numbers of surgeons.
Operative Time Length of Hospital Stay
Fonouni et al448 reported a trend towards longer average Among 9 publications (with unreported donor sample
operative time for laparoscopic compared with open donor sizes) reviewed by Fonouni et al,448 4 of the 9 found no differ-
nephrectomy, and Yuan et al and Wilson et al confirmed lon- ence in length of hospital stay between the groups, while the
ger operative times for laparoscopic procedures.450,451 Meta- remaining 5 found longer length of stay with open versus
analysis by Yuan et al451 estimated that laparoscopic ne- laparoscopic nephrectomy. Meta-analysis of 16 studies (in-
phrectomy requires an average of 51 minutes longer surgical cluding 1681 donors) by Yuan et al451 identified significantly
time (95% CI, 33-68 minutes). Surgery times averaged 2 to shorter length of hospital stay after laparoscopic compared
3 hours for open nephrectomy and 3 to 4 hours for laparo- with open nephrectomy (mean difference, −1.3 days; 95%
scopic nephrectomy. CI, −1.7 to −0.8).451 Significant trends toward shorter length
of stay were found with standard laparoscopic (mean differ-
ence, −1.3 days; 95% CI, −1.9 to −0.7) and hand-assisted
Blood Loss
laparoscopic (mean difference, −1.3 days; 95% CI, −2.1 to
Five of the 8 publications included in the review by −0.5) compared with open nephrectomy.450
Fonouni et al448 reported less perioperative blood loss with
laparoscopic nephrectomy, while the other 3 found no signif-
icant differences in blood loss between the approaches. Meta- Return to Work
analysis by Yuan et al,451 including 12 studies with 917 The time to return to work was reported in one systematic
donors, found a small but statistically significantly increase review based on pooled data from 9 studies capturing
in perioperative blood loss with open vs laparoscopic ne- 1016 donors. Laparoscopic nephrectomy was associated
phrectomy (mean difference, −99.6 mL; 95% CI, −165.9 to with a statistically significant and clinically meaningful re-
−33.4) or open versus hand-assisted laparoscopy (−112.8 mL; duction in time to return to work (mean difference,
95% CI, −169.1 to −56.0).451 −16.4 days; 95% CI, −23.0 to −9.7).451
C.Agnello SE 0304
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 308 of 569 PageID #:
S86 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S502 www.transplantjournal.com
Pain and Physical Functioning et al451 found no significant differences in blood loss with
Among 6 studies describing analgesia requirements in the standard compared with hand-assisted laparoscopic nephrec-
review by Wilson et al,450 4 reported significant reductions tomy (mean difference, −20.7 mL; 95% CI, −43.9 to 2.6).
in morphine requirements with laparoscopic versus open
neprhrectomy. One study showed that donors who underwent Warm Ischemia Time
laparoscopic nephrectomy required fewer days of analgesia Yuan et al451 found a small, statistically significant reduc-
postdischarge (3.3 vs 7.8 days, P < 0.001), while another re- tion in warm ischemia time with hand-assisted compared
ported a nonsignificant reduction in visual analogue pain scale with standard laparoscopy (mean difference, −1.0 minutes;
scores after laparoscopic nephrectomy. The meta-analysis by 95% CI, −1.4 to −0.6), but this small difference does not
Yuan et al451 of 3 studies including 306 donors showed supe- appear to be clinically meaningful.
rior 36-item Medical Outcomes Study Short Form (SF-36)
physical functioning (mean difference, 6.6; 95% CI, 2.3-
Length of Hospital Stay
10.8; P = 0.002) and bodily pain scores (mean difference,
5.9; 95% CI, 1.6-10.3; P = 0.007) with laparoscopic com- Based on 6 studies comprising 320 donors, donors under-
pared with open nephrectomy. going standard laparoscopic nephrectomy had a slight reduc-
tion in average length hospital stay compared to those
What Prior Guidelines Recommend undergoing hand-assisted laparoscopic nephrectomy (mean
difference, 0.3 days; 95% CI, 0.1-0.6),451 although the differ-
Other guidelines have also recommended laparoscopic or
ence (less than 1 day) appears to be modest.
minimally surgical invasive approaches for living donor ne-
A clinical trial at 2 centers published after these systematic
phrectomy48,50,54,452 based on evidence supporting lower
reviews described 190 donors randomized to hand-assisted
morbidity, less pain and analgesia requirements, and earlier
or standard laparoscopy for left donor nephrectomy.454
return to normal activity compared with open nephrectomy.
Hand-assisted laparoscopy resulted in shorter operative time
CARI notes equivalent rates of major complications with
(mean, 159 vs 188 minutes; P = 0.001) and a small reduction
laparoscopic versus open nephrectomy (with complications
in warm ischemia time (2 vs 5 minutes; P < 0.001). Intraop-
after laparoscopy largely due to catastrophic bleeding due
erative complication rate (5% vs 11%, P = 0.12), length of
to failure of intraoperative securing of the vascular pedicle),
stay (both 3 days; P = 0.14), postoperative complication rate
larger resource requirements for laparoscopy, but advantages
(8% vs 8%; P = 1.00), potential graft-related complications
with laparoscopy in terms of reduced analgesia requirements
(6% vs 13%; P = 0.14), and physical function at 1 month
and faster return to normal activity.453 The European Associ-
follow-up (P = 0.55) did not significantly differ between
ation of Urology concludes that laparoscopy offers equiva-
the groups.
lent complication rates and graft outcomes as open
nephrectomy but shorter convalescence and better cosmetic
results.55 The Japanese Society of Endourology emphasizes Novel Minimally-Invasive Nephrectomy Approaches
the importance of experience, recommending that institu- In recent years, innovations in laparoscopic surgery have
tions commencing laparoscopic living donor nephrectomy provided transplant surgeons with a range of techniques and
should do so under the direction of an accredited minimally invasive instruments. Robotic-assisted, total robotic,
laparoscopist.452 and single port nephrectomies have been described in case re-
ports, small series, and small trials at experienced centers.455-459
A systematic review and meta-analysis published after the
Minimally Invasive Nephrectomy Approaches: ERT’s systematic review for this guideline examined 190 ar-
Standard Laparoscopic Versus Hand-Assisted ticles published through March 2016 reporting short-term
Laparoscopic Nephrectomy complications after minimally invasive donor nephrec-
Three systematic reviews presented evidence comparing tomy460; of these, outcomes from 41 articles that compared
standard living donor laparoscopic nephrectomy and hand- 2 or more minimally invasive nephrectomy approaches were
assisted laparoscopic living donor nephrectomy, and summa- included in a meta-analysis. Publication dates of identified ar-
rize very low to low quality evidence supporting similar ticles ranged from 2000 to 2015; most studies were retro-
outcomes across these approaches448,450,451 (Evidence Report spective case series. Although the sample included some
Table 4, SDC, http://links.lww.com/TP/B434; Supplemental prospective series, there were only 16 RCTs. The distribution
Appendix Table C4, SDC, http://links.lww.com/TP/B432). of 32 038 donors according to operative technique was: lap-
aroscopic, 57.4%; hand-assisted laparoscopic, 25.3%; mini-
Operative Time open, 4.5%; hand-assisted retroperitoneoscopic, 3.8%;
Yuan et al451 reviewed 7 trials including 387 donors that retroperitoneoscopic, 3.7%; single-port laparoscopic (ie, lapa-
compared hand-assisted laparoscopic nephrectomy to stan- roscopic single-site surgery [LESS]), 3.8%; and robotic-
dard laparoscopic nephrectomy, and found no statistical assisted laparoscopic, 1.3%. Overall, conversion rate to tra-
difference in operating time by meta-analysis (mean differ- ditional open nephrectomy was 1.1%. Intraoperative compli-
ence, −24.6 minutes; 95% CI, −50.8 to 1.7). cation rate was 2.3%, most commonly bleeding (1.5%).
Postoperative complications occurred in 7.3% of donors, in-
Blood Loss cluding infectious complications in 2.6% (mainly wound in-
Wilson et al450 reported varying results for blood loss across fections, 1.6%) and bleeding in 1.0%. Reported mortality
the studies of standard laparoscopic and hand-assisted ne- rate was 0.01%.
phrectomy included in their review, but overall found no Among 7 studies (2 RCTs, 2 prospective, and 3 retrospective)
significant differences between the groups. Similarly, Yuan comparing laparoscopic (n = 1159) with retroperitoneoscopic
C.Agnello SE 0305
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 309 of 569 PageID S87
KDIGO Living Kidney Donor Work Group
#:
503
(n = 311) techniques, there were no significant differences in quality evidence for similar operative times, blood loss, warm
rates of conversion, overall intraoperative or perioperative ischemia times, and length of stay at experienced centers (Evi-
complications.460 Based on 8 studies (3 RCTs, 5 prospective) dence Report Table 5, SDC, http://links.lww.com/TP/B434;
comparing mini-open (n = 322) to endoscopic (n = 288) tech- Supplemental Appendix Table C5, SDC, http://links.lww.
niques (ie, laparoperitoneoscopic, retroperitoneoscopic, with com/TP/B432). Although complication rates of minimally in-
or without hand assistance), intraoperative complications vasive surgery are generally low with experienced surgeons,
were more frequently seen in endoscopic procedures (8.2% complications can be life threatening, and therefore proper
vs 3.4%; RR 1.132.455.35; P = 0.02). This difference was training and experience is critical.
mostly due to intraoperative organ damage, which demon-
strated a trend in favor of open procedures (0% vs 2.8%; Operative Time
RR 0.915.1829.35; P = 0.06). The postoperative complication
Among 14 studies including 2656 donors with available
rate was comparable after mini-open versus laparoscopic do-
data, operative times were similar with left and right laparo-
nor nephrectomy. Ten studies (3 RCTs, 1 prospective study, 6
scopic nephrectomy (weighted mean difference, 1.4 minutes;
retrospective series) compared single-port (n = 764) with
95% CI, −11.7 to 14.4).449
multiport laparoscopic (n = 1214) procedures, among which
pulmonary complications were more frequently reported af-
ter LESS donor nephrectomy (1.5% vs 0%; RR 1.257.5144.94; Blood Loss
P = 0.03). The slightly higher incidence of postoperative Based on data from 15 studies including 3033 donors,
pain after LESS compared with multiport nephrectomy was blood loss was similar between donors who underwent left
not statistically significant (2.7% vs 0.8%; RR 0.903.5614.11; versus right nephrectomy (weighted mean difference, 4.4 mL;
P = 0.07). 95% CI, −19.8 to 28.6).449
Limitations of this systematic review460 include the
varying study designs, outcome definitions and ascertain- Warm Ischemia Time
ment methodologies. A Cochrane review of RCTs published Among 18 studies including 3516 donors, warm ischemia
through January 2016 comparing LESS donor nephrectomy time was also similar among donors undergoing left versus
with laparoscopic donor nephrectomy identified 3 studies in- right nephrectomy (weighted mean difference, −0.02 minutes;
cluding 179 patients, and concluded that data were insuffi- 95% CI, −0.4 to 0.05).449
cient for drawing inferences on outcomes.461 At the present
time, given the current limited experience and lack of robust
safety and outcomes data, robotic, single-port, and natural
Length of Hospital Stay
orifice transluminal nephrectomies are not currently stan- The mean length of hospital stay in 11 studies including
dard of care approaches to living donor nephrectomy and 1370 donors was similar between those undergoing left
should only be performed by surgeons with adequate train- versus right nephrectomy (weighted mean difference, 0.05 days;
ing and experience, and after informed consent. 95% CI, −0.08 to 0.02).449
A subsequent study of 58 599 living donor nephrecto-
mies from a US registry, including 13.9% right nephrecto-
What Prior Guidelines Recommend
mies, found statistically significant but numerically small
The ERBP also recommends that the choice between min- differences in outcomes after right versus left donor nephrec-
imal invasive and standard laparoscopic procedure should be tomy, including higher rates of conversion from laparoscopic
based on the local expertise.50 No other guidelines recom- to open nephrectomy (1.9% vs 0.95%, P ≤ 0.00001; OR
mend a preference for standard laparoscopy versus hand-
1.162.022.52), delayed allograft function (5.7% vs 4.2%,
assisted or other minimally invasive approaches. P < 0.0001; HR 1.241.381.53) and early graft thrombosis
(1.1% vs 0.79%, P = 0.006; HR1.181.481.86).462 The authors
Left Versus Right Laparoscopic Nephrectomy concluded that the laterality of donor nephrectomy should
In the absence of reasons to procure the right kidney (eg, be based on surgeon preference and experience.
vascular or urological abnormalities), the left kidney should
be procured in laparoscopic living donor nephrectomy be-
cause of the relative technical ease associated with a longer Laparoscopic Procedure Type for Right Nephrectomy
venous pedicle. However, the choice of which kidney to pro- Use of hand-assisted laparoscopy over standard laparos-
cure should be made to minimize short-term and long-term copy for right donor nephrectomy is controversial, as some
complications in the donor. Thus, the presence of renal pa- authors report caudal position of the liver that limits the
renchymal, vascular or urological abnormalities which are working space for the hand assisted approach.463 A trial at
not contraindications to donation may favor the use of a referral center with longstanding expertise in the standard
an abnormal right kidney for donation and transplantation, laparoscopic right nephrectomy explored the safety and
for the goal of leaving the donor with the “more normal” feasibility of right hand-assisted approach by randomly
kidney and/or to minimize complications related to multiple assigning 40 donors to either approach.464 As compared
vascular pedicles. Recent evidence supports safe laparoscopic with laparoscopic right nephrectomy, hand-assisted right
procurement of the right kidney without increased risk of ad- nephrectomy resulted in slightly shorter warm ischemia
verse outcomes compared with procurement of the left kidney, time (2.8 vs 3.9 minutes; P < 0.001) and increased blood
although the evidence is weak. The ERT examined one system- loss (187 vs 50 mL, P < 0.001), while operative time, com-
atic review by Liu et al449 comparing right with left laparo- plication rate, pain, hospital stay and 1 year quality of life
scopic living donor nephrectomy, and identified very low scores were not significantly different between the groups.
C.Agnello SE 0306
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 310 of 569 PageID #:
S88 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S
504 www.transplantjournal.com
Multiple Renal Arteries the current guideline, we recommend that nontransfixing
Kidneys with multiple renal arteries are common. A study clips should never be used to ligate the renal artery in donor
of CT scan results performed during living donor evaluation nephrectomy.
reported a prevalence of 18% to 30% for multiple renal ar-
teries, with up to 15% bilateral involvement.465-467 Multiple
RESEARCH RECOMMENDATIONS
renal arteries may adversely affect donor safety and recipient
outcome. Multiple renal arteries may lead to intraoperative • Define the incidence of perioperative outcomes in representa-
technical difficulties and complications, such as increased op- tive donor samples (ie, not limited to experienced centers with
erative time, complicated dissection, or bleeding. Further- a limited number of surgeons) according to nephrectomy sur-
more, either arterial reconstructions need to be created after gical approach and side.
procurement or multiple arterial anastomoses are needed in • Define outcomes of nephrectomy surgical approaches accord-
the recipient, both of which may be associated with compli- ing to baseline donor characteristics (eg, BMI, renal vascular
anatomy).
cations. A small accessory artery that supplies a minor part
• Define the outcomes of novel minimally invasive approaches
of the upper pole (subjectively assessed using predonation to donor nephrectomy to guide future recommendations and
CT scans) can often be safely sacrificed. However, an acces- appropriate use of these techniques.
sory artery that vascularizes the lower pole and the proximal • Determine the optimal training and experience levels necessary
ureter must be saved and reconstructed after nephrectomy. In to define proficiency with donor nephrectomy approaches.472
the case of a complex venous anatomy, there is usually only
one domain vein, and the remaining veins can be tied off. A
systemic review by Ahmadi et al468 capturing reports of out- CHAPTER 18: ETHICAL, LEGAL AND POLICY
comes associated with vascular multiplicity in living donors CONSIDERATIONS
in the past decade concluded that renal arterial multiplicity The ERT search parameters did not identify evidence from
(up to 3 renal arteries) and venous anomalies should not eligible studies pertinent to the recommendations in chapter
be a contraindication to living kidney donation. Vascular 18 and therefore the following recommendations are “Not
anomalies require longer operative times to manage, but Graded.”
were not associated with significant negative impact on do-
nor or graft outcomes with modern surgical techniques Ethical and Legal Framework
and high surgical skills. As most living donors with multiple
18.1: Local laws and regulations on living donation should
renal arteries in the reported studies had a maximum of 3 be followed and explained as needed to donor candidates.
renal arteries, conclusions cannot be drawn for donors 18.2: Where local laws or policies impede the ethical practice
with 4 or more arteries. Prior guidelines have also con- of living donation, avenues to advocate for change
cluded that multiple arteries is generally not a contraindi- should be explored.
cation to living kidney donation.48,54,55 18.3: Autonomy (self-determination) in the willingness or not
to be considered as a living donor should be respected
Nontransfixing Vascular Clips during all phases of the evaluation and donation pro-
cesses. Transplant programs should support autonomy
Hemorrhagic deaths of living kidney donors from failure through a fully informed consent process.
of nontransfixing vascular clips (eg, Weck Hem-o-lok;
Teleflex Medical, Bannockburn, IL) used to ligate the donor Policies for Donor Candidate Identification
renal artery were first documented in 2006.469,470 Despite a
Class II recall of the Hem-o-lok clip for laparoscopic donor 18.4: Public awareness of opportunities for living donation
nephrectomy by the US FDA in 2006, and a FDA Black Box should be increased through education, donor advocacy,
Warning that use of the Weck Hem-o-lok hemostatic clip to evaluation efficiencies, and removal of disincentives.
ligate the renal artery in living donor nephrectomy is contra- 18.5: Transplant candidates should be assisted in identifying
living donor candidates, as long as these efforts respect do-
indicated, use of these clips is still reported. A 2011 ASTS
nor autonomy and do not exert undue pressure to donate.
survey reported that Hem-o-lok or other clips are still used 18.6: Donor candidates should be informed of the dangers of
by some surgeons as sole means of arterial control in laparo- transplant tourism.
scopic donor nephrectomy.469 Subsequently, in a 2013 survey 18.7: Transplant programs should define and disclose their
of 645 members of the European Society for Organ Transplan- policies for the acceptance of donor candidates identi-
tation, 20% of respondents reported use of clips (locking and fied through public solicitation.
nonlocking) to close the arterial stump.471 Of the 121 re-
ported hemorrhagic events, slippage and dislodgement of Financial Support
clips occurred in at least 58 (47.9%).471 All surgeons operat-
18.8: Donor candidates should be informed of the availability
ing on a living organ donor should select vascular control
of legitimate financial assistance for expenses from eval-
techniques that entail tissue transfixion and assure a safe op- uation and donation.
erative recovery. The Hem-o-lok and other surgical clips
should not be used to ligate the donor renal artery. Communication of Policies
18.9: Nondirected donors and donors participating in paired
What Prior Guidelines Recommend donation should be informed of the transplant pro-
The CARI guideline states that the use of a nontransfixing gram’s policy on contact with the recipient and other
technique for securing the renal artery is not recommended, paired donation participants at all stages in the dona-
particularly with laparoscopic donor nephrectomy.453 In tion process.
C.Agnello SE 0307
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 311 of 569 PageID S89
KDIGO Living Kidney Donor Work Group
#:
505
18.10: Transplant programs should disclose the extent of the Policies for Donor Candidate Identification
expected postdonation program-patient relationship be-
fore donation, including whether the donor can seek People may not be aware of or have accurate knowledge of
medical care at the transplant center after donation. living donation.480 Recipient candidates may not feel com-
18.11:Regional policies should ensure access to kidney replace- fortable sharing their need for an organ donor with their so-
ment therapy (dialysis and/or transplantation) for do- cial network for reasons including not knowing how to ask,
nors who develop kidney failure. misunderstanding of risks, and fear for harm to the donor
candidate.481,482 A 2015 AST Live Donor Community of
Practice consensus statement on “Best Practices in Live Kid-
RATIONALE ney Donation” deemed implementation of approaches to
Ethical and Legal Framework for Living Donation empower transplant candidates and their loved one in their
search for a living donor to be a high priority.148,483 Develop-
Living kidney donation must be practiced within a frame-
ing effective methods to address the growing organ shortage,
work of the laws and regulations of each country and its
including through living donor transplantation, is the highest
governing or regulatory bodies. The legal framework gives
stated priority in the 2015 US OPTN Strategic Plan484 and
legitimacy to living donation and provides some protection
was endorsed in a June 2016 White House Summit on Organ
to the donor.473 All practitioners in transplant programs
Donation.485 Appropriate strategies for promoting living
should be aware of relevant laws and regulations that pertain
donation might include education (public, clinic-based,
to the living donor transplant program.474 Ethical tenets and
home-based), use of advocated (eg, “live donor champions”),
specific transplant program processes are applied to mini-
efficiencies in the evaluation of donor candidates (eg, use of
mize donor risk. See chapter 1 for discussion of the concep-
new information technology) and the removal of disincen-
tual framework for decision-making related to donor
tives.486-490 Effective interventions may include participation
acceptance, and roles and responsibilities in donation-
of family and friends of the transplant candidate to increase
related care, and chapter 2 for details on the processes and
knowledge and awareness of living donation within the pa-
content of informed consent.
tient's social network. The evidence supporting use of social me-
When there is opportunity to identify needs for policy
dia tools to enable transplant candidates to share their need for
and legal changes to improve the practice of living dona-
a living donor with their social network is at an early stage,491
tion, transplant programs should actively participate in the
but given the growing use of the internet and devices such as
review and process to update or change laws, regulations
smartphones globally, application of technology to donor
and policies as needed.475 Laws to regulate donation include,
identification is anticipated to grow and was referenced by
but are not limited to, those that: a) protect the vulnerable
the White House Office of Science and Technology Policy.492
(eg, the cognitively impaired, young people, dependent per-
The ethical appropriateness of strategies for promoting
sons)53,476,477; b) respect autonomy (eg, require informed con-
living donation may vary with the entity employing the
sent); c) prohibit incentives to donate that may create undue
strategy.493 For example, direct promotion of donation
influence (eg, payment for organs in money or in kind).430
by transplant programs may raise ethical concerns for con-
Other relevant laws and policies related to donor protections
flict of interest and risk eroding public trust and the quality
include insurability criteria related to donation status, state
of donor decision-making, but training and support of advo-
tax credits for donation-related expenses, and access to med-
cated (eg, “live donor champions”) can be an appropriate al-
ical leave after donation.
ternative if employed conscientiously, including the careful
Transplant professionals have an ethical duty to act in
use of anticoercion training. Nonprofit groups separate from
the best interests of donor candidates and donors. Self-
transplant programs may have more freedom in promoting
determination related to the donation decision reflects a
donation without challenging ethical norms underlying the
view of people as autonomous agents.478 Donor autonomy
physician-patient relationship, but still bear ethical responsi-
in the willingness to be considered as a donor candidate or
bilities to present evidence-based information and maintain
to withdraw should be respected during all phases of the
public trust. Development of “best practices” related to use
evaluation and donation process. Programs should sup-
of well-designed, evidence-based approaches including tech-
port autonomy through a fully informed consent process
nology to efficiently and ethically expand opportunities for
(chapter 2). Balancing risks and benefits to the donor as well
willing, well-informed patients and potential donors to pursue
as respecting the donor’s wishes for donation addresses the
living donor transplantation and living donation is an impor-
principle of beneficence.
tant priority. All strategies for living donor identification
In the United States, concern that kidney paired donation
must respect donor autonomy and cannot exert undue
could be construed as violating the prohibition of NOTA
pressure to donate. Critically, a wish not to donate must al-
to transfers of organs for valuable consideration was ad-
ways be respected.494
dressed with a specific amendment (“Norwood Act” of
2007) that explicitly defined paired donation as exempt Some people respond to public solicitations by offering to
from NOTA violation.479 Although nonsimultaneous chains be a kidney donor.495 By evaluating these donor candidates,
initiated by nondirected donors do not technically fall within transplant programs are enabling donation.496 In this setting,
the exemption for kidney paired donation, there is arguably the standard evaluation needs to address additional issues re-
no need for an exemption with respect to chains initiated lated to the parties’ limited knowledge of each other, and the
by nondirected donors because they are designed as a series potential for exploitation.497 Recently, the Canadian Society
of gifts, rather than as an exchange of valuable consideration. of Transplantation issued a position paper that addressed is-
See chapter 3 for discussion of clinical and educational issues sues such as privacy, informed consent, and donor follow-up
related to paired donation. associated with public donor solicitation.84
C.Agnello SE 0308
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 312 of 569 PageID #:
S90 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 506 www.transplantjournal.com
Financial Support for Living Donors and Removal kidney to a transplant center to allocate, as they do not have
of Economic Disincentives an identified recipient. Nondirected donors may also donate
Financial support for living kidney donors can be divided by participating in a KPD program or as part of a series of
into cost replacement and financial gain. Living donor candi- matched donor and recipient pairs allowing for a chain of
dates have the right to be informed of available legitimate multiple transplants. Some nondirected living donors and
cost-replacements programs for evaluation and donation- their recipients may request contact with each other
related expenses.430,432 Initiatives to remove financial disincen- postdonation. Clarification before donation of the center’s
tives to kidney donation (ie, replacement of costs incurred policy on such contacts enables participants to adjust their
during the evaluation and donation such as lost income, expectations after donation.511
travel costs, accommodation costs; avoidance of insurance The extent of the physician-patient relationship after do-
discrimination) are acceptable as an issue of justice.430 Mul- nation should be communicated before donation, including
tiple prior living donation guidelines and viewpoints endorse whether the donor can seek medical care at the transplant
reimbursement for out-of-pocket expenses incurred during center after the donation. See chapter 19 for discussion of
the evaluation and donation processes, independent of the postdonation follow-up recommendations.
final decision to proceed with donation.47-49,498-500 Kidney failure is a rare event after living kidney donation,
In the United States, the prohibition of organ exchange but fatal in the absence of kidney replacement therapy. Fed-
for “valuable consideration” in NOTA has been clarified as erally funded programs to assure access to dialysis and
not prohibiting “reasonable payments associated with… transplantation can be promoted as a strategy to protect
the expenses of travel, housing, and lost wages incurred by the safety of living donors if the remaining kidney fails after
the donor of a human organ in connection with the donation donation. Payment for dialysis services, payment for living
of the organ.”501 To date, developing programs for wage re- or deceased donor transplantation, and allocation priority
imbursement has posed the most challenges internationally, for deceased donor kidney transplantation are examples of
including the need for accepted definition of lost wages and such programs. Many countries provide substantial assis-
the potentially large cost of reimbursing very high-income tance for dialysis and transplantation as part of public
donors.502 In December 2016, New Zealand passed legisla- health services. For example in the United States, prior living
tion to provide 100% of a donor's earnings for up to donors receive additional priority points for deceased donor
12 weeks after donation plus childcare assistance for donors kidney transplants,512 which has been associated with higher
who need it while they recover.503 Also in December 2016, transplant rates, shorter time to transplant, and receipt of
the US NLDAC, which to date has provided funds to higher quality allografts compared to candidates with other-
reimburse donation-related travel and lodging costs, an- wise similar clinical profiles.513-515 However, the transplant
nounced that it will conduct an RCT to assess the impact of center must report prior donor status for the patient to re-
interventions intended to remove financial barriers to living ceive priority.516 Priority for prior living donors can also be
organ donation through wage reimbursement.504 Recom- incorporated in KPD matching algorithms.61 In Israel, when
mendations to offer life and disability and/or health insur- a living donor develops ESKD subsequent to the donation,
ance for living donors, or to pass legislation to offer tax the living donor can designate a family member to receive
credits and ensure employment and insurability protections priority on the deceased donor transplant waitlist.517 The
to donors, have also been advanced.55,432,500,505-508 purpose is to reduce the disincentive to current donation
In 2016, the AST launched an online financial toolkit to based on concern that a family member may need a kidney
help donor candidates learn about the finances of being transplant in the future. The impact of this priority on the na-
a living organ donor; this dynamic resource will be ex- tional allocation system and on attitudes and concerns
panded and updated over time.438 Although developed about living donation warrants further study.518
from the perspective of United States-based policies and re-
sources, the information may be helpful to donor candidates RESEARCH RECOMMENDATIONS
in other countries. See chapter 16 for a discussion of the
• Explore approaches to and impact of strengthening partner-
potential financial impact of living donation.
ships between general nephrologists, dialysis providers, and
Financial Incentives for Donation transplant centers regarding living donor kidney transplant
education, access and disparities.483
Payment for a kidney is illegal in almost all parts of the world. • Examine the impact of patient and public education on in-
Suggestions to provide financial incentives for donation elicit creasing donation from living donors.483,490,519
some fears that vulnerable people such as the poor will be • Develop “best practices” related to use of well-designed,
exploited, and that public views of donation and transplantation evidence-based approaches to efficiently and ethically expand
will be damaged.509 The Declaration of Istanbul asserts that opportunities for willing, well-informed patients and potential
because transplant commercialism targets impoverished and donors to pursue living donor transplantation and living
otherwise vulnerable donors, it leads inexorably to inequity and in- donation.492,496,497 Research on strategies to promote living
justice and should be prohibited.421 However, the debate on the donation should evaluate not only efficacy in increasing dona-
tion but also effects on attitudes, quality of donor decision-
acceptability of incentives continues and a formal examination
making, and informed consent.493
of donor incentives within clinical trials has been proposed.509,510 • Examine the experiences of individuals exposed to different
forms of “nonargumentative” influences promoting living do-
Communication of Policies and Postdonation
nation (ie, approaches to shaping behavior that do not at-
Follow-Up Care tempt to persuade through reason, such as appeals to
Living anonymous donors are also referred to as nondi- emotion, messenger effects, and social norms) and whether ex-
rected living donors.411 These are living donors who offer a posed individuals feel the influence was appropriate.493
C.Agnello SE 0309
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 313 of 569 PageID S91
KDIGO Living Kidney Donor Work Group
#:
507
• Examine strategies for reducing financial barriers to living principles and clinical needs to support the practice of living
donation, with particular attention to impact on current donation, including:
disparities in living donor kidney transplantation.432,502
• Determine optimal approaches to allowing or restricting con-
tact between nondirected kidney donors and their recipients.511 • The need to provide accurate outcomes information to do-
• Evaluate the outcomes of incentivizing organ donation via nor candidates and their recipients as a basis for informed
ethically and legally acceptable methods.520,521 consent, especially regarding trends in outcomes and incre-
mental hazards that may be associated with race/ethnicity,
baseline comorbidity, changes in surgical approaches and
management strategies.
CHAPTER 19: POSTDONATION FOLLOW-UP CARE • The need to acquire more robust outcomes data to im-
The ERT search parameters did not identify evidence prove the evaluation process and to provide reliable
from eligible studies pertinent to the recommendations in counseling for donor candidates tailored for demographic
chapter 19 and therefore the following recommendations and health profile.
are “Not Graded.” • The possibility of identification of individual donor clinical
problems through surveillance at a time when intervention
19.1: A personalized postdonation care plan should be pro- is possible.
vided before donation to clearly describe follow-up care • Provision of program-specific feedback to guide quality as-
recommendations, who will provide the care, and how often. surance and performance improvement.
19.2: The following should be performed at least annually • Recognition of the professional obligation of the trans-
postdonation: plant community to continue to collect and monitor infor-
mation on living donor outcomes.
• Blood pressure measurement
• BMI measurement
• Serum creatinine measurement with GFR estimation Similarly, the “European Standards of Quality and Safety
• Albuminuria measurement of Organs Intended for Transplantation” states that ade-
• Review and promotion of a healthy lifestyle including
quate follow-up is part of internationally recognized mea-
regular exercise, healthy diet and abstinence from sures aimed at protecting living kidney donors and ensuring
tobacco the quality and safety of organ donation.524
• Review and support of psychosocial health and well-
being Content of Follow-Up
19.3: Donors should be monitored for CKD, and those Follow-up care after kidney donation should focus on the
meeting criteria for CKD should be managed accord- monitoring and maintenance of general and kidney health in-
ing to the 2012 KDIGO CKD Guideline. cluding reinforcement of healthy lifestyle practices (eg,
19.4: Donors should receive age-appropriate healthcare healthy dietary habits, maintenance of healthy weight, regu-
maintenance, and management of clinical conditions lar aerobic exercise), avoidance of potentially nephrotoxic
and health risk factors according to clinical practice
exposures (eg, tobacco use, nonsteroidal anti-inflammatory
guidelines for the regional population.
drugs, nephrotoxic medications), prevention of diseases that
may cause CKD (eg, hypertension, diabetes mellitus, CVD),
RATIONALE and timely management of such diseases if they develop after
donation. As discussed in chapter 10, hypertension is diag-
Rationale for Postdonation Follow-Up nosed more commonly in kidney donors than in persons with
The living donor evaluation should be regarded as the ini- comparable baseline health, although this may in part reflect
tial stages of a long-term, collaborative relationship between greater monitoring and earlier recognition.224,229 Early de-
2 parties, the donor candidate and the transplant pro- tection and treatment of medical conditions that may subse-
gram.196 The donor enters the relationship with an interest quently affect GFR may protect the donor from further loss
in offering an altruistic and life-extending gift of an organ of GFR or other deterioration in health. Such conditions
for transplantation if he or she is healthy enough to donate should be managed according to clinical practice guidelines
and meets the transplant center’s acceptance criteria. Grounded either by the donor’s primary care provider, or at the trans-
in primary concern for the well-being of the donor, the trans- plant center if appropriate care is available.
plant center should promote the donor’s autonomy, safety Because many donors develop low GFR that meets
and long-term health throughout all phases of care including criteria for diagnosis of CKD and the risk of someday devel-
evaluation, donation surgery, long-term follow-up and oping kidney failure needing treatment with dialysis or
donation-related care. Early postdonation follow-up care is transplantation is slightly higher as a result of donation
routinely practiced as part of postoperative care. In contrast, (see chapter 5),30,32 postdonation monitoring for kidney
responsibility for the coordination and performance of long- disease and CKD risk factors is warranted. Living kidney
term donor follow-up has raised controversies regarding fi- donors should be monitored for CKD and managed ac-
nancial and time burden on both transplant centers and do- cording to the 2012 KDIGO CKD Guideline.124 Donors
nors, especially in countries without universal health should also receive age-appropriate healthcare maintenance,
insurance.522 Monitoring incurs costs and may provide only and management of clinical conditions and health risk fac-
limited information for the majority of donors who may tors according to clinical practice guidelines for the local or
demonstrate stable clinical status and well-being. However, regional population.
as articulated in a 2011 consensus conference report,523 Assessment of psychosocial metrics such as HRQoL have
these concerns are outweighed by fundamental ethical been recommended as part of postdonation follow-up to
C.Agnello SE 0310
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 314 of 569 PageID #:
S92 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S508 www.transplantjournal.com
monitor general well-being,525 and to help transplant centers and frequent loss-to-follow-up.73,530-532 Follow-up defi-
identify donors at risk for poor psychosocial out- ciencies have correlated with patient factors including
comes.414,526 Quality of life measures are collected as part younger donor age, black race, lack of insurance, lower edu-
of standard postdonation follow-up in some donor regis- cational attainment, and greater distance to the transplant
tries.445,527 Guidelines for metric thresholds indicating pres- center.528,530,531 Lack of health insurance had been more
ence of an impairment that would prompt more attention common among living kidney donors in the United States
by the clinician are not specifically defined in donors, but than in the general US population, although that disparity
could be based on existing test standards (eg, scores below has not been present in recent years, perhaps due to changes
0.50 standard deviation of the normative mean on the “Short in the economy and policy changes including the Patient Pro-
Form” (SF) class of measure, SF-36, 12, or 8). tection and Affordable Care Act (ACA).533,534 Lack of insur-
ance and lower educational attainment may pose lesser
Follow-Up Timing and Processes obstacles to follow-up in other countries where national
As part of the informed consent process for donation, healthcare is available. Among US centers in 2008 to 2012,
transplant centers should educate donor candidates on the large annual living donation volumes were also associated
importance of follow-up, disclose donor responsibilities and with increased rates of follow-up deficiencies.530 However,
potential costs of follow-up participation, and develop a per- implementation of mandatory thresholds for collection of
sonalized follow-up plan. Because donors in many countries postdonation clinical and laboratory data in the United
report regular follow-up with a primary provider,528 donor States in 2013 with regulatory implications has led to im-
follow-up and care may be appropriately performed by a pri- proved rates of early follow-up data collection, and high
mary care provider to preserve convenience for the donor. levels of follow-up have been achieved by programs across
However, communication of follow-up information back to the volume spectrum.530,535
the transplant center is necessary for centers to be aware of There is a real need for comprehensive, long-term (lifetime)
the health status of their donors, to comply with reporting follow-up of living donors. Short-term follow-up may detect
mandates (when applicable), and to direct additional care if severe adverse outcomes early after donation but cannot de-
needed. The role of a primary care provider in a donor’s tect gradual, progressive complications that occur late after
follow-up plan should be established before donation. The donation. Clinically important events that may develop in
transplant center should always be available as a resource the intermediate to long-term after donation include hyper-
for the donor’s primary care provider. Documentation of a tension, CKD, metabolic conditions (eg, diabetes mellitus,
donor’s acknowledgement of their responsibility to partici- hyperlipidemia) and CVD, which in turn may increase
pate in follow-up through a signed care plan has been pro- the risk of kidney failure and mortality.
posed as part of education,525 although efficacy in achieving Transplant programs achieve high rates of postdonation
follow-up participation has not been formally evaluated. follow-up have practices that appear to be grounded in: 1) pro-
Particular attention should be given to donors with risk gram conviction that follow-up is essential for donor safety
factors for follow-up deficiencies and to those with baseline and well-being; 2) emphasis on building and maintaining a
factors associated with increased risk of CKD over time. relationship with each donor; 3) use of a systematic approach
Donor education before and at the time of donation is crit- to follow-up; and 4) efforts to minimize the burden on do-
ical to support an informed donation decision, but there is a nors.525 Open-ended, qualitative interviews of US programs
need to continue education on health promoting practices as found that programs with high rates of successful follow-up
the donor recovers and ages. A donor in the midst of making endorsed all 4 of these concepts.525 Recent single-center ex-
a decision to donate or dealing with the early outcomes of do- perience supports that institution of follow-up performance
nation such as postoperative pain and financial pressures improvement initiatives with dedicated program resources
may not absorb all the information on long-term issues. is financially feasible and can result in more accurate and
The establishment of standardized follow-up at serial time complete follow-up after donation.536
points provides a pattern for follow-up care that the donor
may be more likely to continue on regular, yearly preventive Donor Registries
healthcare visits.529 Regular contact between the transplant When national or regional donor registries exist, capture
center and the donor and/or the donor’s primary care physi- of donor follow-up information, either through center
cian also increases familiarity of staff with issues that develop reporting or direct donor contacts, facilitates data aggrega-
after donation, providing an opportunity to modify educa- tion, assessment and dissemination of current donor out-
tion materials or processes to better manage these situations comes data. Informed consent for collection of follow-up
for future donors. While regular healthcare maintenance is information for registry reporting should be requested during
important over the lifetime after donation, data collection the consent for donor evaluation. In countries where regis-
at regular time points by transplant centers should be perti- tries do not exist, efforts should be made to establish and
nent to donation, attainable, and not overly burdensome on maintain a donor registry to support ongoing monitoring of
the donor or the transplant center. postdonation outcomes, as the characteristics of accepted do-
Early follow-up of donors by transplant centers is man- nors and care practices may evolve over time.
dated in some countries including the United States, Some countries have instituted systematic approaches to
Canada and Australia.47,49,73 In the United States, the coun- longer-term living donor follow-up and registry reporting.
try that performs the largest volume of living donor kidney The EULID project began with an 11-nation assessment of
transplants per year, follow-up reporting by centers to living donation practices in Europe that recommended man-
the national transplant registry is limited to 2 years post- datory living donor registration and follow-up data collec-
donation, and has historically suffered from missing data tions through a centralized donor database system, and
C.Agnello SE 0311
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 315 of 569 PageID S93
KDIGO Living Kidney Donor Work Group
#:
509
mandatory regulatory audits at the national and center What Prior Guidelines Recommend
level.444 An online registry is used for reporting of informa- The British Transplantation Society and The Renal As-
tion on donor health status, quality of informed consent, sociation UK Guidelines for Living Donor Kidney Trans-
and psychosocial and socioeconomic outcomes. The plantation state that:48,499
European Living Donor Psychosocial Follow-Up (ELIPSY),
a study conducted in 6 centers of different European coun- • Life-long follow-up is recommended after donor nephrectomy.
tries (Spain, Germany, France, Portugal, Sweden and For donors who are resident in the United Kingdom, this
Turkey) in 2009 to 2012, focused on monitoring donor psy- should be offered locally or at the transplant center according
chosocial well-being and quality of life.527 to the wishes of the donor, but such arrangements must facili-
The SOL-DHR provides a model for involvement of pri- tate the collection of data for submission to the UK Living Do-
nor Registry on long-term morbidity and mortality. Donors
mary care physicians to achieve short- and long-term
from overseas who travel to the United Kingdom to donate
follow-up of donor health and well-being.445 In 1993, a na- are not entitled to follow-up in the United Kingdom but should
tional protocol was initiated for all Swiss transplant cen- be given advice about appropriate follow-up before returning
ters to organize lifelong follow-up after donation at 1, 3, 5, to their country of origin (C1).
7, 10 years, and biennially thereafter, by sending a package • Arrangements must be made to ensure that the unsuitable
to the donor asking the donor to make an appointment with donor, who is unable to proceed to donation, is appropri-
the family physician of their choice. The package contains ately followed up and referred for further investigation
brief information for the donor and the family physician, a and management (B1).
health questionnaire, tubes for blood and urine samples, • National Health Service Blood and Transplant has given a for-
and a prepaid envelope for sending the samples at room tem- mal undertaking that any living kidney donor who develops
kidney failure in the perioperative period as a consequence
perature to the central laboratory. The basic biennial follow-up
of donation will receive priority for a deceased donor kidney
questionnaire is completed by the family physician. In 2002, transplant (not graded).
requests were added for completion an additional 8-Item
Short-Form (SF-8) and social-status questionnaire by the do- Although it was not a specific guideline recommendation
nor. Nonresponses are followed by contacting the recipient, and no evidence was cited, the Amsterdam Forum suggested
the donor’s health insurance and public registries to identify that “As in the general population, based on age and other
whether the donor has died and, if so, the cause of death. medical risk factors (eg, hypertension, proteinuria, hyperlip-
Lifelong follow-up of the living donor’s health status by cen- idemia, impaired glucose tolerance test), kidney donors
ters is required by the Swiss Transplant Law. Although donors should undergo regular long-term follow-up of body weight,
may choose to stop participating, compliance is promoted by BP, blood glucose, serum creatinine, and urinalysis.”38 In the
informing donors about the aims of the protocol and the reg- United States, OPTN policy enacted in 2013 requires trans-
istry before their donation. Similarly, in Norway, donor plant centers to collect and report the following information
follow-up includes initial contacts at weeks 3 to 4, month on their donors to the national registry at 6 months, 1 year,
3, then yearly monitoring for 5 years, and then lifelong con- and 2 years postdonation: serum creatinine, urine protein
tacts every fifth year thereafter. Clinical assessment of donors and a set of clinical outcomes (eg, kidney complications, need
including BP, blood tests and urinalysis examinations is per- for maintenance dialysis, development of hypertension or di-
formed by local county hospitals. Durability of follow-up abetes, loss of insurance due to donation).73 Other guidelines
has been demonstrated as 99, 95, 84, and 77% of donors also suggest postdonation follow-up for at least 1 year49 or
are still seen by local nephrologists at 1, 5, 10, and 15 years lifelong47,55 and provision of donation-related psychosocial
follow-up, respectively (Dr. Hallvard Holdaas, personal services as needed during follow-up have also been pro-
communication). posed.47,409,498 As discussed in chapter 18 (Policy), living do-
In 2017, the US Scientific Registry of Transplant Recipi- nors who develop ESKD in the United States receive priority
ents began planning and transplant program enrollment for for deceased donor kidney allocation.512
a Health Services Research Administration “Living Donor
Collective” pilot project that seeks to achieve life-long living RESEARCH RECOMMENDATIONS
donor follow-up through direct contacts by staff and novel
data linkages. A notable feature of the Collective is a plan to col- • Develop communication and integrated care models to:
lect long-term outcomes data on all persons who present for ◯ Examine electronic tools such as websites or portals to
donor candidate evaluation to provide information on donor maintain contact with donors, facilitate data collection,
exclusion practices and identify a set of healthy controls (eg, and provide messaging to disseminate educational informa-
approved donors who do not donate due to recipient exclusions.) tion to donors.522
◯ Formulate strategies for using inter-institution-compatible
If successful, the goal is to expand to national participation.537
Given the current limited scope and duration of donor electronic medical records to facilitate transmission of do-
nor follow-up information, such as clinical data from care
registries in many countries, and the possibility that some encounters, directly to national registries.531
donors as independent decision makers may choose not ◯ Formulate and assess the outcomes of center-based initiatives
to stay in contact with their transplant center, collection to provide long-term donor follow-up and support through
of outcome data in dedicated, funded research studies, integrated laboratory and clinical monitoring, expansion of
and integration of donor registry data with other informa- preventive health strategies, and fostering of peer education
tion sources such as health administrative data, ESKD and through social support networks between past, current and
mortality registries are also important additional priorities future donors.539
for advancing understanding of long-term health out- • Establish, improve and integrate national/international donor
comes after donation.538 registries to facilitate capture and analysis of long-term
C.Agnello SE 0312
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 316 of 569 PageID #:
S94 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S510 www.transplantjournal.com
outcomes information for large representative samples of liv- Diane Brockington; Patricia Campbell; Marcelo Cantarovich;
ing donors to: (1) address knowledge gaps related to the Jianghua Chen; Xingxing Cheng; Attasit Chokechanachaisakul;
long-term consequences of donation, (2) provide data to in- Rolando Claure-Del Granado; Shandie Covington; Ana
form donor selection criteria, (3) support quality assurance Cusumano; Declan de Freitas; Goffredo Del Rosso; Francis
and program improvement at transplant centers, and 4) sus-
Delmonico; Mary Amanda Dew; Nida Dincel; Christine
tain and strengthen public confidence in the practice of liv-
ing donation.523,531 Dipchand; Edmar Elcarte; Josette Eris; Stephen Fadem; Peter
• Develop HRQoL metric thresholds to identify the presence Ferenci; Sandro Feriozzi; Sebastião Ferreira-Filho; Frances
of an impairment in postdonation psychosocial well-being Flinter; Sue Gagne; Alvaro Garcia Garcia; Mike Germain;
warranting closer attention by the clinician Christiane Geuer; Osama Gheith; Matthias Girndt; Richard
• Improve and assess the efficacy of educational resources to Glassock; Paul Goodyer; Elisa Gordon; William Gourlay;
promote sustained healthy lifestyle choices and behaviors, Jared Grantham; Rebecca Hays; Darlene Heisler; Macey Hen-
and participation in regular postdonation follow-up and care, derson; Seyed M Hosseini-Moghaddam; Osama Hrith;
such as via newsletters, links to transplant center health rec- Salwa Ibrahim; Ikponmwosa Iyawe; Anthony Jevnikar;
ommendations or national guideline website documents. Chandra Mauli Jha; Vivek Jha; Malek Kamoun; Nada
• Develop and assess strategies for communicating new infor-
Kanaan; Clifford Kashtan; Thomas Kelly; Bryce Kiberd;
mation that differs from what a donor was told before dona-
tion, to past donors and their physicians. Hyoung Tae Kim; David Klassen; Nine Knoers; Dirk
Kuypers; David Landsberg; Po Chang Lee; Edgar Lerma;
Marie Ludlow; Mitra Mahdavi-Mazdeh; Martin Mai; Shafi
ACKNOWLEDGMENTS Malik; Francesca Mallamaci; Carlos Marroquin; Jennifer
A special debt of gratitude is owed to the KDIGO cochairs, Martin; Thomas McGregor; Dianne McKay; Enisa Mesic;
David C. Wheeler and Wolfgang C. Winkelmayer, and the Piergiorgio Messa; Renzo Mignani; Euclides Briones Mo-
KDIGO Executive Committee for their invaluable guidance rales; Eugen Mota; Mark Murphy; Abimereki Muzaale;
throughout the development of this guideline. In particu- Charles Newstead; Abdou Niang; Maurizio Nordio;
lar, the authors thank the ERT members for their substantial Uday Nori; Philip O’Connell; Juha Peräsaari; André
contribution to the rigorous assessment of the available evi- Pereira; Gerson Marques Pereira Jr; Ronald Perrone; Carlos
dence. The authors are also especially grateful to the WG Poli-de-Figueiredo; Claudio Ponticelli; Pradeep Kumar Rai;
members for their expertise throughout the entire process Harun Rashid; Praveen Ratanasrimetha; Cibele Rodrigues;
of literature review, meeting participation, the critical writing Jacques Rottembourg; Shaifali Sandal; Richard Sandford;
and editing of the statements and rationale, which made the Craig Schmidt; Silvi Shah; Deepak Sharma; Risa Simon;
publication of this guideline possible. The generous gift of Neeraj Singh; Habib Skhiri; Robert Steiner; Sylvia Stracke;
their time and dedication is greatly appreciated. KDIGO Rodrigo Tagle; Seng Hoe Tan; Ekamol Tantisattamo;
gratefully acknowledges the valuable contributions from Mihály Tapolyai; Gabor Telkes; Christie Thomas; Lee
CKD-Prognosis Consortium and its members for their Anne Tibbles; Vali Toth; Nico Tronchet; Teresa Trottman;
meta-analyses which serve as the basis for the donor selection Yusuke Tsukamoto; Albertien M. van Eerde; Evgueniy
framework presented in this report: Josef Coresh, MD, PhD, Vazelov; Anitha Vijayan; Rafael Weissheimer; Kerstin
Morgan E. Grams, MD, PhD, Yingying Sang, MS, Kunihiro Westman; Christine White; Jean-Luc Wolff; Mai-Szu Wu;
Matsushita, MD, PhD, Shoshana Ballew, PhD, Alex R. Chulwoo Yang; Jane Zill; Carmine Zoccali.
Chang, MD, Eric K. H, Chow MSc, Csaba P. Kovesdy, MD, Participation in the review does not necessarily constitute
Girish N. Nadkarni, MD, MPH, Varda Shalev, MD, MPA. endorsement of the content of this report by the above indi-
KDIGO also thanks the following individuals who provided viduals, or the organization or institution they represent.
valuable feedback: Daniel C. Brennan, MD, Mary Amanda
Dew, PhD, Robert Gaston, MD, Elisa J. Gordon, PhD, MPH,
Rebecca Hays, MSW, Peter C. Harris, PhD, York Pei, MD, Amit X. Garg, MD, PhD
Emilio Poggio, MD, Peter P. Reese, MD, MSCE, Robert Krista L. Lentine, MD, PhD
Steiner, MD, Christie P. Thomas, MD, Roser Torra, MD, Work Group Cochairs
PhD, Vicente E. Torres, MD, PhD, and Matthew Weir, MD.
KDIGO also thanks Josep M. Campistol, MD, PhD, José REFERENCES
Osmar Medina Pestana, MD, PhD, and Faissal A. Shaheen, 1. Uhlig K, Macleod A, Craig J, et al. Grading evidence and recommenda-
MD for their initial contributions to the guideline scope. tions for clinical practice guidelines in nephrology. A position statement
Finally, and on behalf of the WG, the authors gratefully from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int.
2006;70:2058–2065.
acknowledge the careful assessment of the draft guideline by 2. Ethics Committee of the Transplantation Society. The consensus state-
external reviewers. The WG considered all of the valuable ment of the Amsterdam Forum on the Care of the Live Kidney Donor.
comments made and, where appropriate, suggested changes Transplantation 2004;78:491–492.
were incorporated into the final publication. The following 3. Slinin Y, Brasure M, Eidman K, et al. Long-term outcomes of living
kidney donation. Transplantation. 2016;100:1371–1386.
individuals provided feedback during the public review of 4. Lentine KL, Segev DL. Understanding and communicating medical risks
the draft guideline: Mario Abbud-Filho; Sadiq Abdul Baqi; for living kidney donors: a matter of perspective. J Am Soc Nephrol.
ML Aguera; Abdulnaser Alabadi; Bülent Altun; Alesssandro 2017;28:12–24.
Amore; Andrea Angioi; Mariano Arriola; Nancy Ascher; 5. White CM, Ip S, McPheeters M, et al. Using existing systematic reviews
Gloria Ashuntantang; Phillippa Bailey; Peter Barany; Zunaid to replace de novo processes in conducting comparative effectiveness
reviews. In: Methods Guide for Effectiveness and Comparative Effec-
Barday; André Barreto Pereira; Rashad Barsoum; Rommel tiveness Reviews [Internet]. Rockville (MD): Agency for Healthcare Re-
Bataclan; Don Batisky; Leticia Belmont-Martinez; Roberta search and Quality (US); 2008-.AHRQ Methods for Effective Health
Billman; Annie-Claude Blouin; Yassine Bouatou; Neil Boudville; Care; 2009.
C.Agnello SE 0313
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 317 of 569 PageID S95
KDIGO Living Kidney Donor Work Group
#:
511
6. Viswanathan M, Berkman ND, Dryden DM, et al. Assessing risk of bias 33. Lam NN, Lentine KL, Garg AX. End-stage renal disease risk in live kidney
and confounding in observational studies of interventions or exposures: donors: what have we learned from two recent studies? Curr Opin
further development of the RTI item bank. AHRQ Methods for Effective Nephrol Hypertens. 2014;23:592–596.
Health Care: Rockville (MD); 2013. 34. Lam NN, Lentine KL, Levey AS, et al. Long-term medical risks to the
7. Grams ME, Sang Y, Levey AS, et al. Kidney-failure risk projection for the living kidney donor. Nat Rev Nephrol. 2015;11:411–419.
living kidney-donor candidate. N Engl J Med. 2016;374:411–421. 35. Kiberd BA, Clase CM. Cumulative risk for developing end-stage
8. Huang N, Foster MC, Lentine KL, et al. Estimated GFR for living kidney renal disease in the US population. J Am Soc Nephrol. 2002;13:
donor evaluation. Am J Transplant. 2016;16:171–180. 1635–1644.
9. Guyatt GH, Oxman AD, Kunz R, et al. Going from evidence to recom- 36. Steiner RW. The risks of living kidney donation. N Engl J Med. 2016;
mendations. BMJ. 2008;336:1049–1051. 374:479–480.
10. Atkins D, Best D, Briss PA, et al. Grading quality of evidence and strength 37. Grams ME, Garg AX, Lentine KL. Kidney-failure risk projection for the
of recommendations. BMJ. 2004;328:1490. living kidney-donor candidate. N Engl J Med. 2016;374:2094–2095.
11. Guyatt GH, Schunemann HJ, Djulbegovic B, et al. Guideline panels 38. Delmonico F, Council of the Transplantation Society. A report of the
should not GRADE good practice statements. J Clin Epidemiol. 2015; Amsterdam forum on the care of the live kidney donor: data and medical
68:597–600. guidelines. Transplantation. 2005;79:S53–S66.
12. AGREE Collaboration. Development and validation of an international ap- 39. Hays RE. Informed consent of living kidney donors: pitfalls and best
praisal instrument for assessing the quality of clinical practice guidelines: practice. Curr Transpl Rep. 2015;2:29–34.
the AGREE project. Qual Saf Health Care 2003;12:18–23. 40. Thiessen C, Kim YA, Formica R, et al. Written informed consent for living
13. Shiffman RN, Shekelle P, Overhage JM, et al. Standardized reporting of kidney donors: practices and compliance with CMS and OPTN require-
clinical practice guidelines: a proposal from the Conference on Guideline ments. Am J Transplant. 2013;13:2713–2721.
Standardization. Ann Intern Med. 2003;139:493–498. 41. Valapour M, Kahn JP, Bailey RF, et al. Assessing elements of informed
14. Institute of Medicine. Finding what works in health care: Standards consent among living donors. Clin Transplant. 2011;25:185–190.
for systematic reviews. The National Academies Press: Washington, 42. Gordon EJ. Informed consent for living donation: a review of key empiri-
DC, 2011. cal studies, ethical challenges and future research. Am J Transplant.
15. Institute of Medicine. Clinical practice guidelines we can trust. The Na- 2012;12:2273–2280.
tional Academies Press: Washington, DC, 2011. 43. Housawi AA, Young A, Boudville N, et al. Transplant professionals vary
16. Thiessen C, Gordon EJ, Reese PP, et al. Development of a donor- in the long-term medical risks they communicate to potential living kid-
centered approach to risk assessment: rebalancing nonmaleficence ney donors: an international survey. Nephrol Dial Transplant. 2007;22:
and autonomy. Am J Transplant. 2015;15:2314–2323. 3040–3045.
17. Sixty-Third World Health Assembly. WHA63.22. Agenda item 11.21, 21 44. Rodrigue JR, Pavlakis M, Danovitch GM, et al. Evaluating living kidney
May 2010 Human organ and tissue transplantation. Available at: http:// donors: relationship types, psychosocial criteria, and consent processes
apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R22-en.pdf. (Accessed: at US transplant programs. Am J Transplant. 2007;7:2326–2332.
September 7, 2016). 45. Gordon EJ, Butt Z, Jensen SE, et al. Opportunities for shared decision
18. Abecassis M, Adams M, Adams P, et al. Consensus statement on the making in kidney transplantation. Am J Transplant. 2013;13:1149–1158.
live organ donor. JAMA. 2000;284:2919–2926. 46. Dew MA, Jacobs CL, Jowsey SG, et al. Guidelines for the psychosocial
19. Tong A, Chapman JR, Wong G, et al. Living kidney donor assessment: evaluation of living unrelated kidney donors in the United States. Am J
challenges, uncertainties and controversies among transplant nephrolo- Transplant. 2007;7:1047–1054.
gists and surgeons. Am J Transplant. 2013;13:2912–2923. 47. Canadian Council for Donation and Transplantation. Enhancing living
20. Tong A, Chapman JR, Wong G, et al. Screening and follow-up of living donation: a Canadian forum—report and recommendations, February
kidney donors: a systematic review of clinical practice guidelines. Trans- 9-12, 2006, Vancouver, British Columbia.
plantation. 2011;92:962–972. 48. The British Transplantation Society and The Renal Association. The
21. Cozzi E, Biancone L, López-Fraga M, et al. long-term outcome of liv- United Kingdom guidelines for living donor kidney transplanta-
ing kidney donation: position paper of the European Committee on tion. Third Edition, 2011. Available at: https://bts.org.uk/wp-con-
Organ Transplantation, Council of Europe. Transplantation. 2016;100: tent/uploads/2016/09/19_BTS_RA_Living_Donor_Kidney-1.pdf.
270–271. (Accessed: September 7, 2016).
22. Reese PP, Caplan AL, Kesselheim AS, et al. Creating a medical, ethical, 49. National Health and Medical Research Council. Organ and tissue donation
and legal framework for complex living kidney donors. Clin J Am Soc by living donors. Guidelines for ethical practice for health professionals,
Nephrol. 2006;1:1148–1153. 2007. Available at: https://www.nhmrc.gov.au/guidelines-publications/
23. Segev DL, Muzaale AD, Caffo BS, et al. Perioperative mortality and long- e75. (Accessed: September 7, 2016).
term survival following live kidney donation. JAMA. 2010;303:959–966. 50. Abramowicz D, Cochat P, Claas FH, et al. European Renal Best Practice
24. Matas AJ, Bartlett ST, Leichtman AB, et al. Morbidity and mortality after Guideline on kidney donor and recipient evaluation and perioperative
living kidney donation, 1999-2001: survey of United States transplant care. Nephrol Dial Transplant. 2015;30:1790–1797.
centers. Am J Transplant. 2003;3:830–834. 51. OPTN (Organ Procurement and Transplantation Network)/UNOS (United
25. Hadjianastassiou VG, Johnson RJ, Rudge CJ, et al. 2509 living donor Network for Organ Sharing). OPTN Policies, Policy 14: Living Donation.
nephrectomies, morbidity and mortality, including the UK introduction http://optn.transplant.hrsa.gov/governance/policies/. (Accessed: June 28, 2017).
of laparoscopic donor surgery. Am J Transplant. 2007;7:2532–2537. 52. Gesetz über die Spende, Entnahme und Übertragung von Organen.
26. Young A, Storsley L, Garg AX, et al. Health outcomes for living kidney do- [Legislation on the donation, harvesting and transplantation of organs]
nors with isolated medical abnormalities: a systematic review. Am J (Transplantationsgesetz - TPG) From November 5, 1997 (Bundesgesetzblatt
Transplant. 2008;8:1878–1890. I page 2631).
27. Lafranca JA, Hagen SM, Dols LF, et al. Systematic review and meta- 53. Campbell M, Wright L, Greenberg RA, et al. How young is too young to
analysis of the relation between body mass index and short-term donor be a living donor? Am J Transplant. 2013;13:1643–1649.
outcome of laparoscopic donor nephrectomy. Kidney Int. 2013;83:931–939. 54. Spanish Society of Nephrology (S.E.N.) and Spanish Transplant Organi-
28. Schold JD, Goldfarb DA, Buccini LD, et al. Comorbidity burden and peri- sation (ONT). Recommendations for living-donor kidney transplantation.
operative complications for living kidney donors in the United States. Clin Nefrologia 2010;30:1–105.
J Am Soc Nephrol. 2013;8:1773–1782. 55. Kälble T, Lucan M, Nicita G, et al. EAU guidelines on renal transplantation.
29. Lentine KL, Lam NN, Axelrod D, et al. Perioperative complications after
Eur Urol. 2005;47:156–166.
living kidney donation: a national study. Am J Transplant. 2016;16:
56. Living Donor Informed Consent Checklist. Available at: https://optn.
1848–1857.
transplant.hrsa.gov/resources/living-donation. (Accessed: June 29, 2017).
30. Muzaale AD, Massie AB, Wang MC, et al. Risk of end-stage renal dis-
57. Plain language informed consent policy summary (English and Spanish).
ease following live kidney donation. JAMA. 2014;311:579–586.
31. Anjum S, Muzaale AD, Massie AB, et al. Patterns of end-stage renal dis- Available at: https://optn.transplant.hrsa.gov/resources/living-donation.
ease caused by diabetes, hypertension, and glomerulonephritis in live (Accessed: June 29, 2017).
kidney donors. Am J Transplant. 2016;16: 3540–3547. 58. Tan JC, Gordon EJ, Dew MA, et al. Living donor kidney transplantation:
32. Mjoen G, Hallan S, Hartmann A, et al. Long-term risks for kidney donors. facilitating education about live kidney donation—recommendations from
Kidney Int. 2014;86:162–167. a consensus conference. Clin J Am Soc Nephrol. 2015;10:1670–1677.
C.Agnello SE 0314
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 318 of 569 PageID #:
S96 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 512 www.transplantjournal.com
59. European Best Practice Guidelines for Renal Transplantation. Section II: 84. Fortin MC, Buchman D, Wright L, et al. Public solicitation of anonymous
Evaluation and selection of donors. Nephrol Dial Transplant 2000;15:39–51. organ donors: a position paper by the Canadian Society of Transplanta-
60. Melcher ML, Blosser CD, Baxter-Lowe LA, et al. Dynamic challenges tion. Transplantation. 2017;101:17–20.
inhibiting optimal adoption of kidney paired donation: findings of a con- 85. Cook RI, Wreathall J, Smith A, et al. Probabilistic risk assessment of
sensus conference. Am J Transplant. 2013;13:851–860. accidental ABO-incompatible thoracic organ transplantation before
61. OPTN (Organ Procurement and Transplantation Network)/UNOS (United and after 2003. Transplantation. 2007;84:1602–1609.
Network for Organ Sharing). OPTN Policies, Policy 13: Kidney paired do- 86. Gloor JM, Lager DJ, Moore SB, et al. ABO-incompatible kidney trans-
nation (KPD). Available at: http://optn.transplant.hrsa.gov/governance/ plantation using both A2 and non-A2 living donors. Transplantation.
policies. (Accessed: June 28, 2017). 2003;75:971–977.
62. Mamode N, Lennerling A, Citterio F, et al. Anonymity and live-donor 87. Bachelet T, Martinez C, Del Bello A, et al. Deleterious impact of donor-
transplantation: an ELPAT view. Transplantation. 2013;95:536–541. specific anti-HLA antibodies toward HLA-Cw and HLA-DP in kidney
63. Bingaman AW, Wright FH Jr, Kapturczak M, et al. Single-center kidney transplantation. Transplantation. 2016;100:159–166.
paired donation: the Methodist San Antonio experience. Am J Trans- 88. Filippone EJ, Farber JL. Humoral immune response and allograft function
plant. 2012;12:2125–2132. in kidney transplantation. Am J Kidney Dis. 2015;66:337–347.
64. Hendren E, Gill J, Landsberg D, et al. Willingness of directed living donors 89. Tait BD, Süsal C, Gebel HM, et al. Consensus guidelines on the testing
and their recipients to participate in kidney paired donation programs. and clinical management issues associated with HLA and non-HLA an-
Transplantation. 2015;99:1894–1899. tibodies in transplantation. Transplantation. 2013;95:19–47.
65. Cuffy MC, Ratner LE, Siegler M, et al. Equipoise: ethical, scientific, and 90. Segev DL, Gentry SE, Melancon JK, et al. Characterization of waiting
clinical trial design considerations for compatible pair participation in kidney times in a simulation of kidney paired donation. Am J Transplant. 2005;
exchange programs. Am J Transplant. 2015;15:1484–1489. 5:2448–2455.
66. Young A, Kim SJ, Gibney EM, et al. Discovering misattributed paternity 91. Montgomery JR, Berger JC, Warren DS, et al. Outcomes of ABO-
in living kidney donation: prevalence, preference, and practice. Trans- incompatible kidney transplantation in the United States. Transplanta-
plantation. 2009;87:1429–1435. tion. 2012;93:603–609.
67. Ross LF. Good ethics requires good science: why transplant programs 92. Montgomery RA, Lonze BE, King KE, et al. Desensitization in HLA-
should not disclose misattributed parentage. Am J Transplant. 2010; incompatible kidney recipients and survival. N Engl J Med. 2011;365:
10:742–746. 318–326.
68. Wright L, MacRae S, Gordon D, et al. Disclosure of misattributed pater- 93. Segev DL, Gentry SE, Warren DS, et al. Kidney paired donation and
nity: issues involved in the discovery of unsought information. Semin Dial. optimizing the use of live donor organs. JAMA. 2005;293:1883–1890.
94. Matas AJ, Smith JM, Skeans MA, et al. OPTN/SRTR 2013 Annual Data
2002;15:202–206.
69. Mataya L, Meadow J, Thistlethwaite JR Jr, et al. Disclosing health and Report: kidney. Am J Transplant. 2015;15(Suppl 2):1–34.
95. de Klerk M, Haase-Kromwijk BJ, Witvliet M, et al. [Favourable results of
health behavior information between living donors and their recipients.
the first 2 years of the Dutch paired, living donor, kidney exchange pro-
Clin J Am Soc Nephrol. 2015;10:1609–1616.
gramme]. Ned Tijdschr Geneeskd. 2007;151:130–133.
70. Hizo-Abes P, Young A, Reese PP, et al. Attitudes to sharing personal
96. Segev DL, Veale JL, Berger JC, et al. Transporting live donor kidneys for
health information in living kidney donation. Clin J Am Soc Nephrol.
kidney paired donation: initial national results. Am J Transplant. 2011;11:
2010;5:717–722.
71. Seem DL, Lee I, Umscheid CA, et al. Excerpt from PHS guideline for re- 356–360.
ducing HIV, HBV and HCV transmission through organ transplantation. 97. Treat EG, Miller ET, Kwan L, et al. Outcomes of shipped live donor kidney
Am J Transplant. 2013;13:1953–1962. transplants compared with traditional living donor kidney transplants.
72. Rodrigue JR, Ladin K, Pavlakis M, et al. Disclosing recipient information Transpl Int. 2014;27:1175–1182.
to potential living donors: preferences of donors and recipients, before 98. Melcher ML, Leeser DB, Gritsch HA, et al. Chain transplantation: initial
and after surgery. Am J Transplant. 2011;11:1270–1278. experience of a large multicenter program. Am J Transplant. 2012;12:
73. OPTN (Organ Procurement and Transplantation Network)/UNOS (United 2429–2436.
Network for Organ Sharing). OPTN Policies, Policy 18: Data submission 99. Aikawa A, Kawamura T, Shishido S, et al. ABO-incompatible living-
requirements. http://optn.transplant.hrsa.gov/governance/policies/. (Accessed: donor pediatric kidney transplantation in Japan. Clinics (Sao Paulo).
June 28, 2017). 2014;69(Suppl 1):22–27.
74. Danovitch GM, Chapman J, Capron AM, et al. Organ trafficking 100. Aikawa A, Saito K, Takahashi K. Trends in ABO-incompatible kidney
and transplant tourism: the role of global professional ethical transplantation. Exp Clin Transplant. 2015;13(Suppl 1):18–22.
standards—the 2008 Declaration of Istanbul. Transplantation. 101. Takahashi K, Saito K, Takahara S, et al. Excellent long-term outcome of
2013;95:1306–1312. ABO-incompatible living donor kidney transplantation in Japan. Am J
75. Allen MB, Abt PL, Reese PP. What are the harms of refusing to allow liv- Transplant. 2004;4:1089–1096.
ing kidney donation? An expanded view of risks and benefits. Am J 102. Lentine KL, Axelrod D, Klein C, et al. Early clinical complications after
Transplant. 2014;14:531–537. ABO-incompatible live-donor kidney transplantation: a national study of
76. Agency for Healthcare Research and Quality: The SHARE Medicare-insured recipients. Transplantation. 2014;98:54–65.
Approach—Using the Teach-Back technique: A reference guide for health 103. Ishikawa N, Yagisawa T, Kimura T, et al. Kidney transplantation of living
care providers. http://www.ahrq.gov/professionals/education/ unrelated and ABO-incompatible donor-recipient combinations. Trans-
curriculum-tools/shareddecisionmaking/tools/tool-6/index.html (Access plant Proc. 2013;45:1242–1244.
date: May 4, 2016). 104. Kong JM, Ahn J, Park JB, et al. ABO incompatible living donor kidney
77. Gordon EJ, Mullee J, Butt Z, et al. Optimizing informed consent in living transplantation in Korea: highly uniform protocols and good medium-
liver donors: evaluation of a comprehension assessment tool. Liver term outcome. Clin Transplant. 2013;27:875–881.
Transpl. 2015;21:1270–1279. 105. Montgomery RA, Locke JE, King KE, et al. ABO incompatible renal
78. Rodrigue JR, Vishnevsky T, Fleishman A, et al. Patient-reported out- transplantation: a paradigm ready for broad implementation. Transplan-
comes following living kidney donation: a single center experience. J Clin tation. 2009;87:1246–1255.
Psychol Med Settings. 2015;22:160–168. 106. Opelz G, Morath C, Süsal C, et al. Three-year outcomes following 1420
79. Faden RR, Beauchamp T. A history and theory of informed consent. ABO-incompatible living-donor kidney transplants performed after ABO
New York: Oxford University Press; 1986.
antibody reduction: results from 101 centers. Transplantation. 2015;
80. Millis MA, Simmerling M. Prisoners as organ donors: is it worth the
99:400–404.
effort? Is it ethical? Transplant Proc. 2009;41:23–24.
107. OPTN (Organ Procurement and Transplantation Network)/UNOS
81. Ross LF. What the medical excuse teaches us about the potential living
(United Network for Organ Sharing). National Data Reports. https://optn.
donor as patient. Am J Transplant. 2010;10:731–736. transplant.hrsa.gov/data/view-data-reports/national-data/. (Accessed
82. Thiessen C, Kim YA, Formica R, et al. Opting out: confidentiality and June 28, 2017).
availability of an 'alibi' for potential living kidney donors in the USA. 108. Axelrod D, Segev DL, Xiao H, et al. Economic impacts of ABO-
J Med Ethics. 2015;41:506–510. incompatible live donor kidney transplantation: A national study
83. Maple NH, Hadjianastassiou V, Jones R, et al. Understanding risk in living of Medicare-insured recipients. Am J Transplant. 2016;16:
donor nephrectomy. J Med Ethics. 2010;36:142–147. 1465–1473.
C.Agnello SE 0315
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 319 of 569 PageID S97
KDIGO Living Kidney Donor Work Group
#:
513
109. Orandi BJ, Luo X, Massie AB, et al. Survival benefit with kidney trans- 132. Fan L, Inker LA, Rossert J, et al. Glomerular filtration rate estimation using
plants from HLA-incompatible live donors. N Engl J Med. 2016;374: cystatin C alone or combined with creatinine as a confirmatory test.
940–950. Nephrol Dial Transplant. 2014;29:1195–1203.
110. Axelrod D, Lentine KL, Schnitzler MA, et al. The incremental cost of in- 133. Inker LA, Schmid CH, Tighiouart H, et al. Estimating glomerular fil-
compatible living donor kidney transplant: A national cohort analysis. tration rate from serum creatinine and cystatin C. N Engl J Med.
Am J Transpl. 2017. ePub ahead of print. 2012;367:20–29.
111. Clavien PA, Barkun J, de Oliveira ML, et al. The Clavien-Dindo classifica- 134. Matsushita K, van der Velde M, Astor BC, et al. Association of estimated
tion of surgical complications: five-year experience. Ann Surg. 2009;250: glomerular filtration rate and albuminuria with all-cause and cardiovascu-
187–196. lar mortality in general population cohorts: a collaborative meta-analysis.
112. Mjøen G, Øyen O, Holdaas H, et al. Morbidity and mortality in 1022 con- Lancet. 2010;375:2073–2081.
secutive living donor nephrectomies: benefits of a living donor registry. 135. Levey AS, de Jong PE, Coresh J, et al. The definition, classification, and
Transplantation. 2009;88:1273–1279. prognosis of chronic kidney disease: a KDIGO Controversies Confer-
113. Lentine KL, Lam NN, Schnitzler MA, et al. Predonation prescription opi- ence report. Kidney Int. 2011;80:17–28.
oid use: a novel risk factor for readmission after living kidney donation. 136. Matsushita K, Mahmoodi BK, Woodward M, et al. Comparison of
Am J Transplant. 2017;17:744–753. risk prediction using the CKD-EPI equation and the MDRD study equation
114. Cohn SL. Preoperative evaluation for noncardiac surgery. Ann Intern for estimated glomerular filtration rate. JAMA. 2012;307:1941–1951.
Med. 2016;165:ITC81–ITC96. 137. Shlipak MG, Matsushita K, Arnlov J, et al. Cystatin C versus creatinine in
115. Fleisher LA, Beckman JA, Brown KA, et al. ACC/AHA 2007 guidelines determining risk based on kidney function. N Engl J Med. 2013;369:
on perioperative cardiovascular evaluation and care for noncardiac sur- 932–943.
gery: a report of the American College of Cardiology/American Heart As- 138. Hallan SI, Matsushita K, Sang Y, et al. Age and association of kidney
sociation Task Force on Practice Guidelines (Writing Committee to measures with mortality and end-stage renal disease. JAMA. 2012;
Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation 308:2349–2360.
for Noncardiac Surgery): developed in collaboration with the American 139. Kasiske BL, Anderson-Haag T, Israni AK, et al. A prospective controlled
Society of Echocardiography, American Society of Nuclear Cardiology, study of living kidney donors: three-year follow-up. Am J Kidney Dis.
Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, So- 2015;66:114–124.
ciety for Cardiovascular Angiography and Interventions, Society for Vas- 140. Ibrahim HN, Foley R, Tan L, et al. Long-term consequences of kidney
cular Medicine and Biology, and Society for Vascular Surgery. Circulation. donation. N Engl J Med. 2009;360:459–469.
2007;116:e418–499. 141. Garg AX, Muirhead N, Knoll G, et al. Proteinuria and reduced kidney
116. Ferket BS, Genders TS, Colkesen EB, et al. Systematic review of guide- function in living kidney donors: a systematic review, meta-analysis,
lines on imaging of asymptomatic coronary artery disease. J Am Coll and meta-regression. Kidney Int. 2006;70:1801–1810.
Cardiol. 2011;57:1591–1600. 142. Cohney S, Kanellis J, Howell M. The CARI guidelines. Donor renal func-
117. Chee YL, Crawford JC, Watson HG, et al. Guidelines on the assessment tion. Nephrology (Carlton). 2010;15(Suppl 1):S137–S145.
of bleeding risk prior to surgery or invasive procedures. British Commit- 143. Blantz RC, Steiner RW. Benign hyperfiltration after living kidney donation.
tee for Standards in Haematology. Br J Haematol. 2008;140:496–504. J Clin Invest. 2015;125:972–974.
118. Fernández Fresnedo G, de la Oliva Valentín M, Cruzado JM, et al. 144. Lenihan CR, Busque S, Derby G, et al. Longitudinal study of living kidney
[Objectives and methodology of S.E.N-ONT guidelines for living donor donor glomerular dynamics after nephrectomy. J Clin Invest. 2015;125:
kidney transplantation]. Nefrologia. 2010;30(Suppl 2):1–2. 1311–1318.
119. Devereaux PJ, Mrkobrada M, Sessler DI, et al. Aspirin in patients under- 145. Fehrman-Ekholm I, Duner F, Brink B, et al. No evidence of accelerated
going noncardiac surgery. N Engl J Med. 2014;370:1494–1503. loss of kidney function in living kidney donors: results from a cross-
120. Guyatt GH, Akl EA, Crowther M, et al. Executive summary: Antithrom- sectional follow-up. Transplantation. 2001;72:444–449.
botic Therapy and Prevention of Thrombosis, 9th ed: American College 146. Fournier C, Pallet N, Cherqaoui Z, et al. Very long-term follow-up of living
of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. kidney donors. Transpl Int. 2012;25:385–390.
2012;141:7S–47S. 147. Cherikh WS, Young CJ, Kramer BF, et al. Ethnic and gender related dif-
121. Qaseem A, Snow V, Fitterman N, et al. Risk assessment for and strate- ferences in the risk of end-stage renal disease after living kidney dona-
gies to reduce perioperative pulmonary complications for patients under-
tion. Am J Transplant. 2011;11:1650–1655.
going noncardiothoracic surgery: a guideline from the American College
148. LaPointe Rudow D, Hays R, Baliga P, et al. Consensus confer-
of Physicians. Ann Intern Med. 2006;144:575–580.
ence on best practices in live kidney donation: recommendations
122. American Society of Anesthesiologists Task Force on Perioperative Man-
to optimize education, access, and care. Am J Transplant. 2015;15:
agement of patients with obstructive sleep apnea. Practice guidelines for
914–922.
the perioperative management of patients with obstructive sleep apnea:
an updated report by the American Society of Anesthesiologists Task 149. Wang X, Vrtiska TJ, Avula RT, et al. Age, kidney function, and risk factors
Force on Perioperative Management of patients with obstructive sleep associate differently with cortical and medullary volumes of the kidney.
apnea. Anesthesiology 2014;120:268–286. Kidney Int. 2014;85:677–685.
123. Mills E, Eyawo O, Lockhart I, et al. Smoking cessation reduces postop- 150. Glodny B, Unterholzner V, Taferner B, et al. Normal kidney size and its
erative complications: a systematic review and meta-analysis. Am J influencing factors—a 64-slice MDCT study of 1.040 asymptomatic
Med. 2011;124:144–154 e148. patients. BMC Urol. 2009;9:19.
124. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work 151. Emamian SA, Nielsen MB, Pedersen JF, et al. Kidney dimensions at so-
Group. KDIGO 2012 clinical practice guideline for the evaluation and nography: correlation with age, sex, and habitus in 665 adult volunteers.
management of chronic kidney disease. Kidney Int 2013:1–150. AJR Am J Roentgenol. 1993;160:83–86.
125. Earley A, Miskulin D, Lamb EJ, et al. Estimating equations for glomerular 152. Norden G, Lennerling A, Nyberg G. Low absolute glomerular filtration
filtration rate in the era of creatinine standardization: a systematic review. rate in the living kidney donor: a risk factor for graft loss. Transplantation.
Ann Intern Med. 2012;156:785–795. 2000;70:1360–1362.
126. Wesson L. Physiology of the Human Kidney. New York: Grune & 153. Zaky ZS, Gebreselassie S, Poggio ED. Evaluation of kidney function and
Stratton; 1969. structure in potential living kidney donors: implications for the donor and
127. Jafar TH, Islam M, Jessani S, et al. Level and determinants of kidney recipient. Curr Transpl Rep. 2015;2:15–21.
function in a South Asian population in Pakistan. Am J Kidney Dis. 154. Mandelbrot DA, Pavlakis M, Danovitch GM, et al. The medical evaluation
2011;58:764–772. of living kidney donors: a survey of US transplant centers. Am J Trans-
128. Levey AS, Stevens LA, Schmid CH, et al. A new equation to estimate plant. 2007;7:2333–2343.
glomerular filtration rate. Ann Intern Med. 2009;150:604–612. 155. Inker LA. Albuminuria: time to focus on accuracy. Am J Kidney Dis.
129. Soveri I, Berg UB, Bjork J, et al. Measuring GFR: a systematic review. Am 2014;63:378–381.
J Kidney Dis. 2014;64:411–424. 156. Gansevoort RT, Verhave JC, Hillege HL, et al. The validity of screen-
130. Ognibene A, Grandi G, Lorubbio M, et al. KDIGO 2012 clinical practice ing based on spot morning urine samples to detect subjects with
guideline CKD classification rules out creatinine clearance 24 hour urine microalbuminuria in the general population. Kidney Int Suppl. 2005:
collection? Clin Biochem. 2016;49:85–89. S28–35.
131. Gaillard F, Flamant M, Lemoine S, et al. Estimated or measured GFR in 157. Mogensen CL. Microalbuminuria and kidney function: notes on
living kidney donors work-up? Am J Transplant. 2016;16:3024–3032. methods, interpretation and classification. NY: Wiley; 1986.
C.Agnello SE 0316
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 320 of 569 PageID #:
S98 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 514 www.transplantjournal.com
158. Boudville N, Kanellis J. The CARI guidelines. Donors at risk: proteinuria. 185. Olsburgh J, Thomas K, Wong K, et al. Incidental renal stones in potential
Nephrology (Carlton). 2010;15(Suppl 1):S106–S110. live kidney donors: prevalence, assessment and donation, including role
159. Kasiske BL, Ravenscraft M, Ramos EL, et al. The evaluation of living of ex vivo ureteroscopy. BJU Int. 2013;111:784–792.
renal transplant donors: clinical practice guidelines. Ad Hoc Clinical 186. Pearle MS, Goldfarb DS, Assimos DG, et al. Medical management of
Practice Guidelines Subcommittee of the Patient Care and Education kidney stones: AUA guideline. J Urol. 2014;192:316–324.
Committee of the American Society of Transplant Physicians. J Am 187. Türk C, Petřík A, Sarica K, et al. EAU guidelines on diagnosis and conser-
Soc Nephrol. 1996;7:2288–2313. vative management of urolithiasis. Eur Urol. 2016;69:468–474.
160. Cohen RA, Brown RS. Clinical practice. Microscopic hematuria. N 188. Ferraro PM, Curhan GC, D'Addessi A, et al. Risk of recurrence of
Engl J Med. 2003;348:2330–2338. idiopathic calcium kidney stones: analysis of data from the literature.
161. Davis R, Jones JS, Barocas DA, et al. Diagnosis, evaluation and J Nephrol. 2017;30:227–233.
follow-up of asymptomatic microhematuria (AMH) in adults: AUA guideline. 189. Rule AD, Krambeck AE, Lieske JC. Chronic kidney disease in kidney
J Urol. 2012;188:2473–2481. stone formers. Clin J Am Soc Nephrol. 2011;6:2069–2075.
162. Sutton JM. Evaluation of hematuria in adults. JAMA. 1990;263:2475–2480. 190. Alexander RT, Hemmelgarn BR, Wiebe N, et al. Kidney stones and
163. Vivante A, Afek A, Frenkel-Nir Y, et al. Persistent asymptomatic isolated kidney function loss: a cohort study. BMJ. 2012;345:e5287.
microscopic hematuria in Israeli adolescents and young adults and risk 191. Shoag J, Halpern J, Goldfarb DS, et al. Risk of chronic and end stage kid-
for end-stage renal disease. JAMA. 2011;306:729–736. ney disease in patients with nephrolithiasis. J Urol. 2014;192:1440–1445.
164. Chow KM, Kwan BC, Li PK, et al. Asymptomatic isolated microscopic 192. Kummer AE, Grams M, Lutsey P, et al. Nephrolithiasis as a risk factor for
haematuria: long-term follow-up. QJM. 2004;97:739–745. CKD: the Atherosclerosis Risk in Communities Study. Clin J Am Soc
165. Kovacevic Z, Jovanovic D, Rabrenovic V, et al. Asymptomatic mi- Nephrol. 2015;10:2023–2029.
croscopic haematuria in young males. Int J Clin Pract. 2008;62: 193. Strang AM, Lockhart ME, Amling CL, et al. Living renal donor allograft
406–412. lithiasis: a review of stone related morbidity in donors and recipients.
166. Lee YM, Baek SY, Kim JH, et al. Analysis of renal biopsies performed in J Urol. 2008;179:832–836.
children with abnormal findings in urinary mass screening. Acta Paediatr. 194. Fink HA, Wilt TJ, Eidman KE, et al. Medical management to prevent
2006;95:849–853. recurrent nephrolithiasis in adults: a systematic review for an American
167. Park YH, Choi JY, Chung HS, et al. Hematuria and proteinuria in a mass College of Physicians Clinical Guideline. Ann Intern Med. 2013;158:
school urine screening test. Pediatr Nephrol. 2005;20:1126–1130. 535–543.
168. Lam NN, Lentine KL, Garg AX, et al. Renal and cardiac assessment of 195. Qaseem A, Dallas P, Forciea MA, et al. Dietary and pharmacologic man-
living kidney donor candidates. Nat Rev Nephrol. 2017;13:420–428. agement to prevent recurrent nephrolithiasis in adults: a clinical practice
169. Savige J, Rana K, Tonna S, et al. Thin basement membrane nephropa- guideline from the American College of Physicians. Ann Intern Med.
thy. Kidney Int. 2003;64:1169–1178. 2014;161:659–667.
170. Koushik R, Garvey C, Manivel JC, et al. Persistent, asymptomatic, 196. AST/ASTS/NATCO/UNOS Joint Societies Work Group. Evaluation
microscopic hematuria in prospective kidney donors. Transplantation. of the Living Kidney Donor—a Consensus Document from the AST/
2005;80:1425–1429. ASTS/NATCO/UNOS Joint Societies Work Group.
171. Choi SR, Sun IO, Hong YA, et al. The role of kidney biopsy to determine 197. Campion EW, Glynn RJ, DeLabry LO. Asymptomatic hyperuricemia.
donation from prospective kidney donors with asymptomatic urinary ab- Risks and consequences in the Normative Aging Study. Am J Med.
normalities. Transplant Proc. 2012;44:11–13. 1987;82:421–426.
172. Jais JP, Knebelmann B, Giatras I, et al. X-linked Alport syndrome: natural 198. Zhang W, Doherty M, Pascual E, et al. EULAR evidence based recom-
history and genotype-phenotype correlations in girls and women belong- mendations for gout. Part I: Diagnosis. Report of a task force of the
ing to 195 families: a “European Community Alport Syndrome Concerted Standing Committee for International Clinical Studies Including Thera-
Action” study. J Am Soc Nephrol. 2003;14:2603–2610. peutics (ESCISIT). Ann Rheum Dis. 2006;65:1301–1311.
173. Temme J, Peters F, Lange K, et al. Incidence of renal failure and 199. Lipkowitz MS. Regulation of uric acid excretion by the kidney. Curr
nephroprotection by RAAS inhibition in heterozygous carriers of Rheumatol Rep. 2012;14:179–188.
X-chromosomal and autosomal recessive Alport mutations. Kidney Int. 200. Krishnan E. Reduced glomerular function and prevalence of gout:
2012;81:779–783. NHANES 2009-10. PLoS One. 2012;7:e50046.
174. Gross O, Weber M, Fries JW, et al. Living donor kidney transplantation 201. Kasiske BL, Anderson-Haag T, Ibrahim HN, et al. A prospective con-
from relatives with mild urinary abnormalities in Alport syndrome: trolled study of kidney donors: baseline and 6-month follow-up. Am J
long-term risk, benefit and outcome. Nephrol Dial Transplant. 2009; Kidney Dis. 2013;62:577–586.
24:1626–1630. 202. Moody WE, Ferro CJ, Edwards NC, et al. Cardiovascular effects of
175. D'Amico G. Natural history of idiopathic IgA nephropathy and factors unilateral nephrectomy in living kidney donors. Hypertension. 2016;
predictive of disease outcome. Semin Nephrol. 2004;24:179–196. 67:368–377.
176. Szeto CC, Lai FM, To KF, et al. The natural history of immunoglobulin a 203. Lam NN, McArthur E, Kim SJ, et al. Gout after living kidney donation: a
nephropathy among patients with hematuria and minimal proteinuria. matched cohort study. Am J Kidney Dis. 2015;65:925–932.
Am J Med. 2001;110:434–437. 204. Lam NN, Garg AX, Segev DL, et al. Gout after living kidney donation:
177. Suzuki K, Honda K, Tanabe K, et al. Incidence of latent mesangial correlations with demographic traits and renal complications. Am J
IgA deposition in renal allograft donors in Japan. Kidney Int. 2003;63: Nephrol. 2015;41:231–240.
2286–2294. 205. Braga F, Pasqualetti S, Ferraro S, et al. Hyperuricemia as risk factor
178. Kido R, Shibagaki Y, Iwadoh K, et al. Persistent glomerular hematuria in for coronary heart disease incidence and mortality in the general pop-
living kidney donors confers a risk of progressive kidney disease in do- ulation: a systematic review and meta-analysis. Clin Chem Lab Med.
nors after heminephrectomy. Am J Transplant. 2010;10:1597–1604. 2016;54:7–15.
179. Richardson R, Connelly M, Dipchand C, et al. Kidney paired donation 206. Khanna D, Fitzgerald JD, Khanna PP, et al. 2012 American College of
protocol for participating donors 2014. Transplantation. 2015;99:S1–S88. Rheumatology guidelines for management of gout. Part 1: systematic
180. Ierino F, Kanellis J, CARI. The CARI guidelines. Donors at risk:
nonpharmacologic and pharmacologic therapeutic approaches to hy-
haematuria. Nephrology (Carlton). 2010;15(Suppl 1):S111–S113.
peruricemia. Arthritis Care Res (Hoboken). 2012;64:1431–1446.
181. Savige J, Gregory M, Gross O, et al. Expert guidelines for the manage-
207. van Echteld IA, van Durme C, Falzon L, et al. Treatment of gout pa-
ment of Alport syndrome and thin basement membrane nephropathy.
tients with impairment of renal function: a systematic literature review.
J Am Soc Nephrol. 2013;24:364–375.
J Rheumatol Suppl. 2014;92:48–54.
182. Lorenz EC, Lieske JC, Vrtiska TJ, et al. Clinical characteristics of potential
kidney donors with asymptomatic kidney stones. Nephrol Dial Trans- 208. Kasiske BL, Kumar R, Kimmel PL, et al. Abnormalities in biomarkers of
plant. 2011;26:2695–2700. mineral and bone metabolism in kidney donors. Kidney Int. 2016;90:
183. Hughes P, Caring for Australians with Renal Impairment (CARI). The CARI 861–868.
guidelines. Kidney stones epidemiology. Nephrology (Carlton). 2007; 209. Young A, Hodsman AB, Boudville N, et al. Bone and mineral metab-
12(Suppl 1):S26–S30. olism and fibroblast growth factor 23 levels after kidney donation. Am J
184. Thomas SM, Lam NN, Welk BK, et al. Risk of kidney stones with Kidney Dis. 2012;59:761–769.
surgical intervention in living kidney donors. Am J Transplant. 2013; 210. Garg AX, Pouget J, Young A, et al. Fracture risk in living kidney donors: a
13:2935–2944. matched cohort study. Am J Kidney Dis. 2012;59:770–776.
C.Agnello SE 0317
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 321 of 569 PageID S99
KDIGO Living Kidney Donor Work Group
#:
515
211. Textor SC, Taler SJ, Larson TS, et al. Blood pressure evaluation among 236. Kanji Z, Powe CE, Wenger JB, et al. Genetic variation in APOL1 associ-
older living kidney donors. J Am Soc Nephrol. 2003;14:2159–2167. ates with younger age at hemodialysis initiation. J Am Soc Nephrol.
212. O'Brien E, Parati G, Stergiou G, et al. European Society of Hypertension 2011;22:2091–2097.
position paper on ambulatory blood pressure monitoring. J Hypertens. 237. Kopp JB, Nelson GW, Sampath K, et al. APOL1 genetic variants in focal
2013;31:1731–1768. segmental glomerulosclerosis and HIV-associated nephropathy. J Am
213. Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint Soc Nephrol. 2011;22:2129–2137.
National Committee on prevention, detection, evaluation, and treatment 238. Parsa A, Kao WH, Xie D, et al. APOL1 risk variants, race, and progres-
of high blood pressure. Hypertension. 2003;42:1206–1252. sion of chronic kidney disease. N Engl J Med. 2013;369:2183–2196.
214. Ierino F, Boudville N, Kanellis J. The CARI guidelines. Donors at risk: hy- 239. Meguid El Nahas A, Bello AK. Chronic kidney disease: the global chal-
pertension. Nephrology (Carlton). 2010;15(Suppl 1):S114–S120. lenge. Lancet. 2005;365:331–340.
215. Pascual J, Abramowicz D, Cochat P, et al. European renal best practice 240. Poggio ED, Braun WE, Davis C. The science of stewardship: due
guideline on the management and evaluation of the kidney donor and re- diligence for kidney donors and kidney function in living kidney
cipient. Nefrologia. 2014;34:293–301. donation—evaluation, determinants, and implications for outcomes. Clin
216. Stergiou GS, Asayama K, Thijs L, et al. Prognosis of white-coat and J Am Soc Nephrol. 2009;4:1677–1684.
masked hypertension: International Database of HOme blood pres- 241. Oh CK, Jeon KO, Kim HJ, et al. Metabolic demand and renal mass sup-
sure in relation to Cardiovascular Outcome. Hypertension. 2014;63: ply affecting the early graft function after living donor kidney transplanta-
675–682. tion. Kidney Int. 2005;67:744–749.
217. Hanninen MR, Niiranen TJ, Puukka PJ, et al. Target organ damage and 242. Rook M, Bosma RJ, van Son WJ, et al. Nephrectomy elicits impact
masked hypertension in the general population: the Finn-Home study. of age and BMI on renal hemodynamics: lower postdonation reserve
J Hypertens. 2013;31:1136–1143. capacity in older or overweight kidney donors. Am J Transplant. 2008;
218. Aljadhey H, Tu W, Hansen RA, et al. Comparative effects of non- 8:2077–2085.
steroidal anti-inflammatory drugs (NSAIDs) on blood pressure in patients 243. Lee JH, Kim SC, Han DJ, et al. Risk factors for MDRD-GFR of less than
with hypertension. BMC Cardiovasc Disord. 2012;12:93. 60 mL/min per 1.73 m2 in former kidney donors. Nephrology (Carlton).
219. Elliott WJ. Drug interactions and drugs that affect blood pressure. J Clin 2007;12:600–606.
Hypertens (Greenwich). 2006;8:731–737. 244. Gracida C, Espinoza R, Cedillo U, et al. Kidney transplantation with living
220. Snowden S, Nelson R. The effects of nonsteroidal anti-inflammatory donors: nine years of follow-up of 628 living donors. Transplant Proc.
drugs on blood pressure in hypertensive patients. Cardiol Rev. 2011; 2003;35:946–947.
19:184–191. 245. Textor SC, Taler SJ, Driscoll N, et al. Blood pressure and renal function
221. Eckel RH, Jakicic JM, Ard JD, et al. 2013 AHA/ACC guideline on lifestyle after kidney donation from hypertensive living donors. Transplantation.
management to reduce cardiovascular risk: a report of the American 2004;78:276–282.
College of Cardiology/American Heart Association Task Force on Prac- 246. World Health Organization (WHO). Global Report on Diabetes. Executive
tice Guidelines. J Am Coll Cardiol. 2014;63:2960–2984. Summary. Available at: http://apps.who.int/iris/bitstream/10665/
222. Young JH, Klag MJ, Muntner P, et al. Blood pressure and decline in 204874/1/WHO_NMH_NVI_16.3_eng.pdf. (Accessed: July 31, 2016).
kidney function: findings from the Systolic Hypertension in the Elderly 247. Ng M, Fleming T, Robinson M, et al. Global, regional, and national prev-
Program (SHEP). J Am Soc Nephrol. 2002;13:2776–2782. alence of overweight and obesity in children and adults during
223. Vasan RS, Beiser A, Seshadri S, et al. Residual lifetime risk for developing 1980–2013: a systematic analysis for the Global Burden of Disease
hypertension in middle-aged women and men: the Framingham Heart Study 2013. Lancet. 2014;384:766–781.
Study. JAMA. 2002;287:1003–1010. 248. World Health Organization. Obesity: Preventing and managing global
224. Boudville N, Prasad GV, Knoll G, et al. Meta-analysis: risk for hyperten- epidemic. WHO Technical Report Series No 894, 2000.
sion in living kidney donors. Ann Intern Med. 2006;145:185–196. 249. Padwal RS. Obesity, diabetes, and the metabolic syndrome: the global
225. Garg AX, Prasad GV, Thiessen-Philbrook HR, et al. Cardiovascular scourge. Can J Cardiol. 2014;30:467–472.
disease and hypertension risk in living kidney donors: an analysis of 250. Zobel EH, Hansen TW, Rossing P, et al. Global changes in food supply
health administrative data in Ontario, Canada. Transplantation. 2008; and the obesity epidemic. Curr Obes Rep. 2016;5:449–455.
86:399–406. 251. World Health Organization. Waist Circumference and Waist–Hip Ratio.
226. Lentine KL, Schnitzler MA, Garg AX, et al. Understanding antihyper- Report of a WHO Expert Consultation. Geneva, 8–11 2008.
tensive medication use after living kidney donation through linked na- 252. Boudville N, Isbel N. The CARI guidelines. Donors at risk: impaired glucose
tional registry and pharmacy claims data. Am J Nephrol. 2014;40: tolerance. Nephrology (Carlton). 2010;15(Suppl 1):S133–S136.
174–183. 253. World Health Organization. Global Report on Diabetes. 2016.
227. Lentine KL, Schnitzler MA, Xiao H, et al. Consistency of racial variation in 254. Makaroff LE. The need for international consensus on prediabetes.
medical outcomes among publicly and privately insured living kidney do- Lancet Diabetes Endocrinol. 2017;5:5–7.
nors. Transplantation. 2014;97:316–324. 255. Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guide-
228. Lentine KL, Schnitzler MA, Xiao H, et al. Racial variation in medical out- line on the treatment of blood cholesterol to reduce atherosclerotic
comes among living kidney donors. N Engl J Med. 2010;363:724–732. cardiovascular risk in adults: a report of the American College of
229. Doshi MD, Goggins MO, Li L, et al. Medical outcomes in African Cardiology/American Heart Association Task Force on Practice
American live kidney donors: a matched cohort study. Am J Transplant. Guidelines. J Am Coll Cardiol. 2014;63:2889–2934.
2013;13:111–118. 256. DeMaria EJ, Carmody BJ. Perioperative management of special popula-
230. Lv J, Ehteshami P, Sarnak MJ, et al. Effects of intensive blood pressure tions: obesity. Surg Clin North Am. 2005;85:1283–1289.
lowering on the progression of chronic kidney disease: a systematic re- 257. D'Agati VD, Chagnac A, de Vries AP, et al. Obesity-related glomerulopa-
view and meta-analysis. CMAJ. 2013;185:949–957. thy: clinical and pathologic characteristics and pathogenesis. Nat Rev
231. Lewis EJ, Hunsicker LG, Bain RP, et al. The effect of angiotensin- Nephrol. 2016;12:453–471.
converting-enzyme inhibition on diabetic nephropathy. The Collaborative 258. von Zur-Muhlen B, Berglund D, Yamamoto S, et al. Single-centre long-
Study Group. N Engl J Med. 1993;329:1456–1462. term follow-up of live kidney donors demonstrates preserved kidney
232. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal function but the necessity of a structured lifelong follow-up. Ups J Med
and cardiovascular outcomes in patients with type 2 diabetes and ne- Sci. 2014;119:236–241.
phropathy. N Engl J Med. 2001;345:861–869. 259. Isbel N, CARI guidelines. The CARI guidelines. Donors at risk: obesity.
233. Appel LJ, Wright JT Jr, Greene T, et al. Long-term effects of renin- Nephrology (Carlton). 2010;15(Suppl 1):S121–S132.
angiotensin system-blocking therapy and a low blood pressure goal on 260. Locke JE, Reed RD, Massie A, et al. Obesity increases the risk of
progression of hypertensive chronic kidney disease in African Americans. end-stage renal disease among living kidney donors. Kidney Int. 2017;
Arch Intern Med. 2008;168:832–839. 91:699–703.
234. Appel LJ, Wright JT Jr, Greene T, et al. Intensive blood-pressure control in 261. Narayan KM, Boyle JP, Thompson TJ, et al. Lifetime risk for diabetes
hypertensive chronic kidney disease. N Engl J Med. 2010;363:918–929. mellitus in the United States. JAMA. 2003;290:1884–1890.
235. Friedman DJ, Kozlitina J, Genovese G, et al. Population-based risk 262. Plantinga LC, Crews DC, Coresh J, et al. Prevalence of chronic kidney
assessment of APOL1 on renal disease. J Am Soc Nephrol. 2011;22: disease in US adults with undiagnosed diabetes or prediabetes. Clin
2098–2105. J Am Soc Nephrol. 2010;5:673–682.
C.Agnello SE 0318
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 322 of 569 PageID #:
S100 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 516 www.transplantjournal.com
263. Okamoto M, Suzuki T, Fujiki M, et al. The consequences for live kidney 288. OPTN (Organ Procurement and Transplantation Network)/UNOS (United
donors with preexisting glucose intolerance without diabetic compli- Network for Organ Sharing) Ad Hoc Disease Transmission Advisory
cation: analysis at a single Japanese center. Transplantation. 2010;89: Committee (DTAC). Guidance for Identifying Risk Factors for Mycobacte-
1391–1395. rium tuberculosis (MTB) During Evaluation of Potential Living Kidney
264. Tabak AG, Herder C, Rathmann W, et al. Prediabetes: a high-risk state Donors. Available at: https://optn.transplant.hrsa.gov/resources/
for diabetes development. Lancet. 2012;379:2279–2290. guidance/guidance-for-identifying-risk-factors-for-mycobacterium-
265. Ferrannini E. Definition of intervention points in prediabetes. Lancet tuberculosis-mtb-during-evaluation-of-potential-living-kidney-donors/.
Diabetes Endocrinol. 2014;2:667–675. (Accessed September 7, 2016).
266. Ligthart S, van Herpt TT, Leening MJ, et al. Lifetime risk of developing im- 289. Chin-Hong PV, Schwartz BS, Bern C, et al. Screening and treatment of
paired glucose metabolism and eventual progression from prediabetes Chagas disease in organ transplant recipients in the United States: rec-
to type 2 diabetes: a prospective cohort study. Lancet Diabetes Endocrinol. ommendations from the Chagas in transplant working group. Am J
2016;4:44–51. Transplant. 2011;11:672–680.
267. Chandran S, Masharani U, Webber AB, et al. Prediabetic living 290. Morris MI, Daly JS, Blumberg E, et al. Diagnosis and management of
kidney donors have preserved kidney function at 10 years after donation. tuberculosis in transplant donors: a donor-derived infections consensus
Transplantation. 2014;97:748–754. conference report. Am J Transplant. 2012;12:2288–2300.
268. Zammit AR, Katz MJ, Derby C, et al. Metabolic syndrome and smoking 291. OPTN (Organ Procurement and Transplantation Network)/UNOS (United
are associated with future development of advanced chronic kidney Network for Organ Sharing) Ad Hoc Disease Transmission Advisory
disease in older adults. Cardiorenal Med. 2016;6:108–115. Committee (DTAC). Identifying Risk Factors for West Nile Virus (WNV)
269. Young BA, Katz R, Boulware LE, et al. Risk factors for rapid kidney func- During Evaluation of Potential Living Donors. Available at: https://optn.
tion decline among African Americans: the Jackson Heart Study (JHS). transplant.hrsa.gov/resources/guidance/identifying-risk-factors-
Am J Kidney Dis. 2016;68:229–239. for-west-nile-virus-wnv-during-evaluation-of-potential-living-donors/.
270. Garg AX, Meirambayeva A, Huang A, et al. Cardiovascular disease in (Accessed September 7, 2016).
kidney donors: matched cohort study. BMJ. 2012;344:e1203. 292. Feng S, Buell JF, Cherikh WS, et al. Organ donors with positive viral se-
271. Kaplan B, Ilahe A. Quantifying risk of kidney donation: the truth is not rology or malignancy: risk of disease transmission by transplantation.
out there (yet). Am J Transplant. 2014;14:1715–1716. Transplantation. 2002;74:1657–1663.
272. Amer H, Prieto M, Heimbach JK, et al. Increasing mortality by living 293. Ouseph R, Eng M, Ravindra K, et al. Review of the use of hepatitis B core
antibody-positive kidney donors. Transplant Rev (Orlando). 2010;24:
kidney donation? The devil is in the details. Kidney Int. 2014;85:1469.
167–171.
273. Kirchner VA, Liu PT, Pruett TL. Infection and cancer screening in potential
294. Centers for Disease Control and Prevention (CDC). Testing recommen-
living donors: best practices to protect the donor and recipient. Curr
dations for hepatitis C virus infection. Available at: http://www.cdc.
Transpl Rep. 2015;2:35–43.
gov/hepatitis/hcv/guidelinesc.htm. (Accessed: September 7, 2016).
274. Fishman JA, Grossi PA. Donor-derived infection—the challenge for
295. Johnson RJ, Gretch DR, Yamabe H, et al. Membranoproliferative glo-
transplant safety. Nat Rev Nephrol. 2014;10:663–672.
merulonephritis associated with hepatitis C virus infection. N Engl J
275. Len O, Garzoni C, Lumbreras C, et al. Recommendations for screening
Med. 1993;328:465–470.
of donor and recipient prior to solid organ transplantation and to mini-
296. Natov SN. Transmission of viral hepatitis by kidney transplantation: donor
mize transmission of donor-derived infections. Clin Microbiol Infect.
evaluation and transplant policies (Part 2: hepatitis C virus). Transpl Infect
2014;20(Suppl 7):10–18.
Dis. 2002;4:124–131.
276. Morris MI, Fischer SA, Ison MG. Infections transmitted by transplanta-
297. Abbott KC, Lentine KL, Bucci JR, et al. The impact of transplantation
tion. Infect Dis Clin North Am. 2010;24:497–514.
with deceased donor hepatitis C-positive kidneys on survival in wait-
277. Bohl DL, Brennan DC, Ryschkewitsch C, et al. BK virus antibody titers
listed long-term dialysis patients. Am J Transplant. 2004;4:2032–2037.
and intensity of infections after renal transplantation. J Clin Virol. 2008;
298. European Association for the Study of the Liver. EASL recommendations
43:184–189.
on treatment of hepatitis C 2016. J Hepatol 2017;66:153–194.
278. Bohl DL, Storch GA, Ryschkewitsch C, et al. Donor origin of BK virus
299. Busch MP, Glynn SA, Stramer SL, et al. A new strategy for estimating
in renal transplantation and role of HLA C7 in susceptibility to sustained
risks of transfusion-transmitted viral infections based on rates of detec-
BK viremia. Am J Transplant. 2005;5:2213–2221. tion of recently infected donors. Transfusion. 2005;45:254–264.
279. Mwintshi K, Brennan DC. Prevention and management of cytomegalovi-
300. Muller E, Kahn D, Mendelson M. Renal transplantation between HIV-
rus infection in solid-organ transplantation. Expert Rev Anti Infect Ther.
positive donors and recipients. N Engl J Med. 2010;362:2336–2337.
2007;5:295–304.
301. U.S. Federal Register. Human Immunodeficiency Virus (HIV) Organ Pol-
280. Andrews PA, Emery VC, Newstead C. Summary of the British Transplan-
icy Equity (HOPE) Act Safeguards and Research Criteria for Transplanta-
tation Society guidelines for the prevention and management of CMV
tion of Organs Infected With HIV. A Notice by the National Institutes of
disease after solid organ transplantation. Transplantation. 2011;92:
Health on 06/18/2015. Available at: https://www.federalregister.gov/
1181–1187.
articles/2015/06/18/2015-15034/human-immunodeficiency-virus-
281. Brennan DC, Agha I, Bohl DL, et al. Incidence of BK with tacrolimus ver-
hiv-organ-policy-equity-hope-act-safeguards-and-research-criteria-for.
sus cyclosporine and impact of preemptive immunosuppression reduc-
(Accessed September 7, 2016).
tion. Am J Transplant. 2005;5:582–594.
302. Ison MG, Llata E, Conover CS, et al. Transmission of human immunode-
282. Spinner ML, Saab G, Casabar E, et al. Impact of prophylactic versus pre-
emptive valganciclovir on long-term renal allograft outcomes. Transplan- ficiency virus and hepatitis C virus from an organ donor to four transplant
tation. 2010;90:412–418. recipients. Am J Transplant. 2011;11:1218–1225.
283. Ison MG, Grossi P, AST Infectious Diseases Community of Practice. 303. Blumberg EA, Ison MG, Pruett TL, et al. Optimal testing of the live organ
donor for blood-borne viral pathogens: the report of a consensus confer-
Donor-derived infections in solid organ transplantation. Am J Transplant.
ence. Am J Transplant. 2013;13:1405–1415.
2013;13(Suppl 4):22–30.
304. Ison MG, Abecassis M, Blumberg E, et al. Achieving consensus on in-
284. HIV transmitted from a living organ donor-New York City, 2009. Am J
creased risk donors to improve access to organ transplantation.
Transplant. 2011;11:1334–1337.
Northwestern Agency for Healthcare Research and Quality-funded Con-
285. Garzoni C, Ison MG. Uniform definitions for donor-derived infectious dis-
sensus Conference, presented to the Advisory Committee on Organ Trans-
ease transmissions in solid organ transplantation. Transplantation. 2011;
plantation of the U.S. Department of Health and Human Services, August 2,
92:1297–1300.
2012. Available at: http://www.feinberg.northwestern.edu/sites/transplant/
286. Levi ME, Kumar D, Green M, et al. Considerations for screening live docs/conference/FinalReport.pdf. (Accessed September 7, 2016).
kidney donors for endemic infections: a viewpoint on the UNOS policy. 305. Echenique IA, Cohen D, Rudow DL, et al. Impact of repeat testing of
Am J Transplant. 2014;14:1003–1011. living kidney donors within 14 days of the transplant procedure: a multi-
287. OPTN (Organ Procurement and Transplantation Network)/UNOS center retrospective survey. Transpl Infect Dis. 2014;16:403–411.
(United Network for Organ Sharing). Recognizing Seasonal and 306. Brennan DC, Aguado JM, Potena L, et al. Effect of maintenance immu-
Geographically Endemic Infections in Organ Donors: Consider- nosuppressive drugs on virus pathobiology: evidence and potential
ations during Living Donor Evaluation. 2014 (http://optn.trans- mechanisms. Rev Med Virol. 2013;23:97–125.
plant.hrsa.gov/media/1138/seasonal_disease_guidance.pdf). (Accessed: 307. Green M, Michaels MG. Epstein-Barr virus infection and posttransplant
September 7, 2016). lymphoproliferative disorder. Am J Transplant. 2013;13(Suppl 3):41–54.
C.Agnello SE 0319
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 323 of 569 PageIDS101
KDIGO Living Kidney Donor Work Group
#:
517
308. Morton M, Coupes B, Roberts SA, et al. Epstein-Barr virus infection in 332. American Cancer Society. Guidelines for the Early Detection of
adult renal transplant recipients. Am J Transplant. 2014;14:1619–1629. Cancer. Available at: http://www.cancer.org/healthy/findcancerearly/
309. Beam E, Razonable RR. Cytomegalovirus in solid organ transplantation: epide- cancerscreeningguidelines/american-cancer-society-guidelines-for-the-
miology, prevention, and treatment. Curr Infect Dis Rep. 2012;14:633–641. early-detection-of-cancer. (Accessed: September 7, 2016).
310. Preiksaitis JK, Brennan DC, Fishman J, et al. Canadian Society of Trans- 333. United Kindgom (UK) National Screening Committee (UK NSC). Current
plantation consensus workshop on cytomegalovirus management UK NSC recommendations. Available at: http://legacy.screening.nhs.uk/
in solid organ transplantation final report. Am J Transplant. 2005; screening-recommendations.php. (Accessed: September 7, 2016).
5:218–227. 334. Lentine KL, Vijayan A, Xiao H, et al. Cancer diagnoses after living kidney
311. Hodson EM, Ladhani M, Webster AC, et al. Antiviral medications for donation: linking U.S. Registry data and administrative claims. Trans-
preventing cytomegalovirus disease in solid organ transplant recipients. plantation. 2012;94:139–144.
Cochrane Database Syst Rev. 2013;2:CD003774. 335. Xiao D, Craig JC, Chapman JR, et al. Donor cancer transmission in kidney
312. Cortes NJ, Afzali B, MacLean D, et al. Transmission of syphilis by solid transplantation: a systematic review. Am J Transplant. 2013;13:2645–2652.
organ transplantation. Am J Transplant. 2006;6:2497–2499. 336. Kauffman HM, Cherikh WS, McBride MA, et al. Deceased donors with a
313. Cortez KJ, Greenwald MA. Current trends in donor testing to detect past history of malignancy: an organ procurement and transplantation
syphilis infection. Curr Infect Dis Rep. 2014;16:423.
network/united network for organ sharing update. Transplantation.
314. Theodoropoulos N, Jaramillo A, Penugonda S, et al. Improving syphilis
2007;84:272–274.
screening in deceased organ donors. Transplantation. 2015;99:438–443.
337. Strauss DC, Thomas JM. Transmission of donor melanoma by organ
315. Meije Y, Piersimoni C, Torre-Cisneros J, et al. Mycobacterial infections in
transplantation. Lancet Oncol. 2010;11:790–796.
solid organ transplant recipients. Clin Microbiol Infect. 2014;20(Suppl 7):
338. Penn I. Malignant melanoma in organ allograft recipients. Transplanta-
89–101.
tion. 1996;61:274–278.
316. Ison MG, Nalesnik MA. An update on donor-derived disease transmis-
339. Buell JF, Beebe TM, Trofe J, et al. Donor transmitted malignancies. Ann
sion in organ transplantation. Am J Transplant. 2011;11:1123–1130.
317. Aguado JM, Torre-Cisneros J, Fortún J, et al. Tuberculosis in solid-organ Transplant. 2004;9:53–56.
340. Bibbins-Domingo K, Grossman DC, Curry SJ, et al. Screening for skin
transplant recipients: consensus statement of the group for the study
of infection in transplant recipients (GESITRA) of the Spanish Society cancer: US preventive services task force recommendation statement.
of Infectious Diseases and Clinical Microbiology. Clin Infect Dis. 2009; JAMA. 2016;316:429–435.
48:1276–1284. 341. Nalesnik MA, Woodle ES, Dimaio JM, et al. Donor-transmitted malignan-
318. Subramanian AK. Tuberculosis in solid organ transplant candidates cies in organ transplantation: assessment of clinical risk. Am J Trans-
plant. 2011;11:1140–1147.
and recipients: current and future challenges. Curr Opin Infect Dis. 2014;
342. Ordon M, Welk B, McArthur E, et al. Risk of nephrectomy in previous
27:316–321.
living kidney donors. Transplantation. 2016;100:1313–1317.
319. Moon SM, Park IA, Kim SM, et al. Living donor and recipient screening
343. Israel GM, Bosniak MA. An update of the Bosniak renal cyst classification
for latent tuberculosis infection by tuberculin skin test and interferon-
system. Urology. 2005;66:484–488.
gamma releasing assay in a country with an intermediate burden of tu-
344. Campbell SC, Lane BR. Chapter 57: Malignant renal tumors. In:
berculosis. J Infect Chemother. 2013;19:1009–1013.
Campbell-Walsh Urology, 11th Edn. Wein AJ, Kavoussi LR, Partin AW,
320. Ariza-Heredia EJ, Beam EN, Lesnick TG, et al. Impact of urinary tract in-
et al. (eds). Elsevier, p. 1314–1364, 2016.
fection on allograft function after kidney transplantation. Clin Transplant. 345. Musquera M, Pérez M, Peri L, et al. Kidneys from donors with incidental
2014;28:683–690. renal tumors: should they be considered acceptable option for trans-
321. Lee JR, Bang H, Dadhania D, et al. Independent risk factors for urinary plantation? Transplantation. 2013;95:1129–1133.
tract infection and for subsequent bacteremia or acute cellular rejection: 346. Valente M, Furian L, Rigotti P. Organ donors with small renal cancer:
a single-center report of 1166 kidney allograft recipients. Transplanta- report of 3 cases. Transplant Proc. 2012;44:1846–1847.
tion. 2013;96:732–738. 347. Sener A, Uberoi V, Bartlett ST, et al. Living-donor renal transplantation of
322. Abdalhamid BA, Al Abadi AN, Al Saghier MI, et al. Strongyloides grafts with incidental renal masses after ex-vivo partial nephrectomy.
stercoralis infection in kidney transplant recipients. Saudi J Kidney Dis BJU Int. 2009;104:1655–1660.
Transpl. 2015;26:98–102. 348. Ghafari A. Transplantation of a kidney with a renal cell carcinoma after
323. Le M, Ravin K, Hasan A, et al. Single donor-derived strongyloidiasis in living donation: a case report. Transplant Proc. 2007;39:1660–1661.
three solid organ transplant recipients: case series and review of the liter- 349. Notify Library. The global vigilence and surveillance database for medical
ature. Am J Transplant. 2014;14:1199–1206. products of human origin. Available at: http://www.notifylibrary.org/.
324. Roseman DA, Kabbani D, Kwah J, et al. Strongyloides stercoralis trans- (Accessed: September 7, 2016).
mission by kidney transplantation in two recipients from a common do- 350. Kuppachi S, Smith RJH, Thomas CP. Evaluation of genetic renal dis-
nor. Am J Transplant. 2013;13:2483–2486. eases in potential living kidney donors. Curr Transpl Rep. 2015;2:1–14.
325. World Health organization (WHO). Strongyloidiasis Epidemiology. 351. Chapman AB, Devuyst O, Eckardt KU, et al. Autosomal-dominant poly-
Available at: http://www.who.int/intestinal_worms/epidemiology/ cystic kidney disease (ADPKD): executive summary from a Kidney Dis-
strongyloidiasis/en/. (Accessed: September 7, 2016). ease: Improving Global Outcomes (KDIGO) Controversies Conference.
326. Huprikar S, Bosserman E, Patel G, et al. Donor-derived Trypanosoma Kidney Int. 2015;88:17–27.
cruzi infection in solid organ recipients in the United States, 2001-2011. 352. Pei Y, Hwang YH, Conklin J, et al. Imaging-based diagnosis of autosomal
Am J Transplant. 2013;13:2418–2425. dominant polycystic kidney disease. J Am Soc Nephrol. 2015;26:746–753.
327. OPTN (Organ Procurement and Transplantation Network)/UNOS (United 353. Kanaan N, Devuyst O, Pirson Y. Renal transplantation in autosomal dom-
Network for Organ Sharing) Ad Hoc Disease Transmission Advisory inant polycystic kidney disease. Nat Rev Nephrol. 2014;10:455–465.
Committee (DTAC). Guidance regarding Ebola virus disease. Available 354. Pei Y, Obaji J, Dupuis A, et al. Unified criteria for ultrasonographic diagno-
at: https://optn.transplant.hrsa.gov/news/guidance-regarding-ebola- sis of ADPKD. J Am Soc Nephrol. 2009;20:205–212.
virus-disease/. (Accessed: September 7, 2016). 355. Simms RJ, Travis DL, Durkie M, et al. Genetic testing in the assessment
328. World Health organization (WHO). Zika virus fact sheet (Updated 2 June of living related kidney donors at risk of autosomal dominant polycystic
2016). Available at: http://www.who.int/mediacentre/factsheets/zika/ kidney disease. Transplantation. 2015;99:1023–1029.
en/. (Accessed: September 7, 2016). 356. Audrezet MP, Cornec-Le Gall E, Chen JM, et al. Autosomal dominant
329. OPTN (Organ Procurement and Transplantation Network)/UNOS (United polycystic kidney disease: comprehensive mutation analysis of PKD1
Network for Organ Sharing) Ad Hoc Disease Transmission Advisory Com- and PKD2 in 700 unrelated patients. Hum Mutat. 2012;33:1239–1250.
mittee (DTAC). Guidance on Zika virus. Available at: https://optn.transplant. 357. Rossetti S, Consugar MB, Chapman AB, et al. Comprehensive molecu-
hrsa.gov/news/guidance-on-zika-virus/. (Accessed: September 7, 2016). lar diagnostics in autosomal dominant polycystic kidney disease. J Am
330. Centers for Disease Control and Prevention (CDC). Global Health. Soc Nephrol. 2007;18:2143–2160.
Available at: http://www.cdc.gov/globalhealth/index.html. (Accessed: 358. Riella LV, Sheridan AM. Testing for high-risk APOL1 alleles in potential liv-
September 7, 2016). ing kidney donors. Am J Kidney Dis. 2015;66:396–401.
331. US Preventative Services Task Force. USPSTF Published recommendations 359. Zwang NA, Shetty A, Sustento-Reodica N, et al. APOL1-associated
for cancer screening. Available at: http://www.uspreventiveservicestaskforce. end-stage renal disease in a living kidney transplant donor. Am J Trans-
org/BrowseRec/Index. (Accessed: September 7, 2016). plant. 2016;16:3568–3572.
C.Agnello SE 0320
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 324 of 569 PageID #:
S102 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 518 www.transplantjournal.com
360. Reeves-Daniel AM, DePalma JA, Bleyer AJ, et al. The APOL1 gene and 388. Nagar R, Sinha S, Raman R. Haemoglobinopathies in eastern Indian
allograft survival after kidney transplantation. Am J Transplant. 2011;11: states: a demographic evaluation. J Community Genet. 2015;6:1–8.
1025–1030. 389. Key NS, Derebail VK. Sickle-cell trait: novel clinical significance. Hematol-
361. Freedman BI, Pastan SO, Israni AK, et al. APOL1 genotype and kidney ogy Am Soc Hematol Educ Program. 2010;2010:418–422.
transplantation outcomes from deceased African American donors. 390. Gebreselassie S, Simmons MN, Montague DK. Genitourinary manifesta-
Transplantation. 2016;100:194–202. tions of sickle cell disease. Cleve Clin J Med. 2015;82:679–683.
362. Kofman T, Audard V, Narjoz C, et al. APOL1 polymorphisms and devel- 391. Reese PP, Hoo AC, Magee CC. Screening for sickle trait among potential
opment of CKD in an identical twin donor and recipient pair. Am J Kidney live kidney donors: policies and practices in US transplant centers.
Dis. 2014;63:816–819. Transpl Int. 2008;21:328–331.
363. Cohen DM, Mittalhenkle A, Scott DL, et al. African American living-kidney 392. Thomas CP, Mansilla MA, Sompallae R, et al. Screening of living kidney
donors should be screened for APOL1 risk alleles. Transplantation. donors for genetic diseases using a comprehensive genetic testing strat-
2011;92:722–725. egy. Am J Transplant. 2017;17:401–410.
364. Lentine KL, Segev DL. Health outcomes among non-Caucasian living 393. Department of Health and Human Services. APOL1 Long-term Kidney
kidney donors: knowns and unknowns. Transpl Int. 2013;26:853–864. Transplantation Outcomes Network (APOLLO) Clinical Centers (Collabo-
365. Ross LF, Thistlethwaite JR Jr. Introducing genetic tests with uncertain im- rative U01). https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-16-
plications in living donor kidney transplantation: ApoL1 as a case study. 025.html. Accessed January 24, 2017.
Prog Transplant. 2016;26:203–206. 394. Department of Health and Human Services. APOL1 Long-term Kidney
366. Chandraker A. The real world impact of APOL1 variants on kidney trans- Transplantation Outcomes Network Scientific and Data Research Center
plantation. Transplantation. 2016;100:16–17. (APOLLO SDRC) (Collaborative U01). https://grants.nih.gov/grants/
367. Freedman BI, Julian BA. Should kidney donors be genotyped for APOL1 guide/rfa-files/RFA-DK-16-024.html. Accessed January 24, 2017.
risk alleles? Kidney Int. 2015;87:671–673. 395. Vikse BE. Pre-eclampsia and the risk of kidney disease. Lancet. 2013;
368. Lentine KL, Schnitzler MA, Garg AX, et al. Race, relationship and renal diag- 382:104–106.
noses after living kidney donation. Transplantation. 2015;99:1723–1729. 396. McDonald SD, Han Z, Walsh MW, et al. Kidney disease after preeclampsia: a sys-
369. Newell KA, Formica RN, Gill JS, et al. Integrating APOL-1 gene vari- tematic review and meta-analysis. Am J Kidney Dis. 2010;55:1026–1039.
ants into renal transplantation: considerations arising from the 397. Vikse BE, Irgens LM, Leivestad T, et al. Preeclampsia and the risk of
end-stage renal disease. N Engl J Med. 2008;359:800–809.
American Society of Transplantation expert conference. Am J Trans-
398. Wang IK, Muo CH, Chang YC, et al. Association between hypertensive
plant. 2017;17:901–911.
disorders during pregnancy and end-stage renal disease: a population-
370. Chan MM, Gale DP. Isolated microscopic haematuria of glomerular ori-
based study. CMAJ. 2013;185:207–213.
gin: clinical significance and diagnosis in the 21st century. Clin Med
399. Beharier O, Shoham-Vardi I, Pariente G, et al. Gestational diabetes
(Lond). 2015;15:576–580.
mellitus is a significant risk factor for long-term maternal renal disease.
371. Miner JH, Baigent C, Flinter F, et al. The 2014 international workshop on
J Clin Endocrinol Metab. 2015;100:1412–1416.
Alport syndrome. Kidney Int. 2014;86:679–684.
400. The Royal College of Radiologists and the College of Radiographers.
372. Niaudet P. Living donor kidney transplantation in patients with hereditary
Protection of Pregnant Patients during Diagnostic Medical Exposures
nephropathies. Nat Rev Nephrol. 2010;6:736–743.
373. Heidet L, Gubler MC. The renal lesions of Alport syndrome. J Am Soc to Ionising Radiation Advice from the Health Protection Agency. Docu-
Nephrol. 2009;20:1210–1215. ments of the Health Protection Agency Radiation, Chemical and Environ-
374. Gast C, Pengelly RJ, Lyon M, et al. Collagen (COL4A) mutations are mental Hazards, 2009. https://www.rcr.ac.uk/sites/default/files/
the most frequent mutations underlying adult focal segmental publication/HPA_preg_2nd.pdf. (Accessed on September 8 2015).
glomerulosclerosis. Nephrol Dial Transplant. 2016;31:961–970. 401. Garg AX, Nevis IF, McArthur E, et al. Gestational hypertension and pre-
375. Weber S, Strasser K, Rath S, et al. Identification of 47 novel mutations in eclampsia in living kidney donors. N Engl J Med. 2015;372:124–133.
patients with Alport syndrome and thin basement membrane nephropa- 402. Reisaeter AV, Roislien J, Henriksen T, et al. Pregnancy and birth after kidney
thy. Pediatr Nephrol. 2016;31:941–955. donation: the Norwegian experience. Am J Transplant. 2009;9:820–824.
376. Kashtan CE. Women with Alport syndrome: risks and rewards of kidney 403. Ibrahim HN, Akkina SK, Leister E, et al. Pregnancy outcomes after kidney
donation. Nephrol Dial Transplant. 2009;24:1369–1370. donation. Am J Transplant. 2009;9:825–834.
377. Favalli V, Disabella E, Molinaro M, et al. Genetic screening of Anderson- 404. Thangaratinam S, Rogozińska E, Jolly K, et al. Interventions to reduce or
Fabry disease in probands referred from multispecialty clinics. J Am Coll prevent obesity in pregnant women: a systematic review. Health Technol
Cardiol. 2016;68:1037–1050. Assess. 2012;16:iii–iv 1-191.
378. Popli S, Molnar ZV, Leehey DJ, et al. Involvement of renal allograft by 405. Allen R, Rogozinska E, Sivarajasingam P, et al. Effect of diet- and lifestyle-
Fabry's disease. Am J Nephrol. 1987;7:316–318. based metabolic risk-modifying interventions on preeclampsia: a meta-
379. Rood IM, Deegens JK, Wetzels JF. Genetic causes of focal segmental analysis. Acta Obstet Gynecol Scand. 2014;93:973–985.
glomerulosclerosis: implications for clinical practice. Nephrol Dial Trans- 406. Rasmussen PE, Nielsen FR. Hydronephrosis during pregnancy: a litera-
plant. 2012;27:882–890. ture survey. Eur J Obstet Gynecol Reprod Biol. 1988;27:249–259.
380. Pollak MR. Familial FSGS. Adv Chronic Kidney Dis. 2014;21:422–425. 407. Garg AX, McArthur E, Lentine KL, et al. Gestational hypertension
381. Sadowski CE, Lovric S, Ashraf S, et al. A single-gene cause in 29.5% of and preeclampsia in living kidney donors. N Engl J Med. 2015;372:
cases of steroid-resistant nephrotic syndrome. J Am Soc Nephrol. 2015; 1469–1470.
26:1279–1289. 408. Duerinckx N, Timmerman L, Van Gogh J, et al. Predonation psychoso-
382. Winn MP, Alkhunaizi AM, Bennett WM, et al. Focal segmental cial evaluation of living kidney and liver donor candidates: a systematic
glomerulosclerosis: a need for caution in live-related renal transplanta- literature review. Transpl Int. 2014;27:2–18.
tion. Am J Kidney Dis. 1999;33:970–974. 409. van Hardeveld E, Tong A. The CARI guidelines. Psychosocial care
383. Donne RL, Abbs I, Barany P, et al. Recurrence of hemolytic uremic syn- of living kidney donors. Nephrology (Carlton). 2010;15(Suppl 1):
drome after live related renal transplantation associated with subsequent S80–S87.
de novo disease in the donor. Am J Kidney Dis. 2002;40:E22. 410. Henderson AJ, Landolt MA, McDonald MF, et al. The living anonymous
384. Zuber J, Fakhouri F, Roumenina LT, et al. Use of eculizumab for atypical kidney donor: lunatic or saint? Am J Transplant. 2003;3:203–213.
haemolytic uraemic syndrome and C3 glomerulopathies. Nat Rev 411. Sharif A. Unspecified kidney donation—a review of principles, practice
Nephrol. 2012;8:643–657. and potential. Transplantation. 2013;95:1425–1430.
385. Hart TC, Gorry MC, Hart PS, et al. Mutations of the UMOD gene are re- 412. Tong A, Craig JC, Wong G, et al. “It was just an unconditional gift.” Self
sponsible for medullary cystic kidney disease 2 and familial juvenile reflections of non-directed living kidney donors. Clin Transplant. 2012;
hyperuricaemic nephropathy. J Med Genet. 2002;39:882–892. 26:589–599.
386. Kirby A, Gnirke A, Jaffe DB, et al. Mutations causing medullary cystic 413. Clemens K, Boudville N, Dew MA, et al. The long-term quality of life of
kidney disease type 1 lie in a large VNTR in MUC1 missed by massively living kidney donors: a multicenter cohort study. Am J Transplant.
parallel sequencing. Nat Genet. 2013;45:299–303. 2011;11:463–469.
387. Ojodu J, Hulihan MM, Pope SN, et al. Incidence of sickle cell trait— 414. Lentine KL, Schnitzler MA, Xiao H, et al. Depression diagnoses after living
United States, 2010. MMWR Morb Mortal Wkly Rep. 2014;63: kidney donation: linking U.S. Registry data and administrative claims.
1155–1158. Transplantation. 2012;94:77–83.
C.Agnello SE 0321
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 325 of 569 PageIDS103
KDIGO Living Kidney Donor Work Group
#:
519
415. Gross CR, Messersmith EE, Hong BA, et al. Health-related quality of life 441. Haljamae U, Nyberg G, Sjostrom B. Remaining experiences of living kid-
in kidney donors from the last five decades: results from the RELIVE ney donors more than 3 yr after early recipient graft loss. Clin Transplant.
study. Am J Transplant. 2013;13:2924–2934. 2003;17:503–510.
416. de Groot IB, Stiggelbout AM, van der Boog PJ, et al. Reduced quality of 442. Johnson EM, Anderson JK, Jacobs C, et al. Long-term follow-up of
life in living kidney donors: association with fatigue, societal participation living kidney donors: quality of life after donation. Transplantation.
and pre-donation variables. Transpl Int. 2012;25:967–975. 1999;67:717–721.
417. Dew MA, DiMartini AF, DeVito Dabbs AJ, et al. Preventive intervention for 443. Weizer N, Weizman A, Shapira Z, et al. Suicide by related kidney donors
living donor psychosocial outcomes: feasibility and efficacy in a random- following the recipients' death. Psychother Psychosom. 1989;51:216–219.
ized controlled trial. Am J Transplant. 2013;13:2672–2684. 444. Manyalich M, Ricart A, Martinez I, et al. EULID project: European living
418. Jowsey SG, Jacobs C, Gross CR, et al. Emotional well-being of living donation and public health. Transplant Proc. 2009;41:2021–2024.
kidney donors: findings from the RELIVE Study. Am J Transplant. 445. Thiel GT, Nolte C, Tsinalis D. Prospective Swiss cohort study of living-
2014;14:2535–2544. kidney donors: study protocol. BMJ Open. 2011;1:e000202.
419. Messersmith EE, Gross CR, Beil CA, et al. Satisfaction with life among 446. Iacoviello BM, Shenoy A, Braoude J, et al. The live donor assessment
living kidney donors: a RELIVE study of long-term donor outcomes. tool: a psychosocial assessment tool for live organ donors. Psychoso-
Transplantation. 2014;98:1294–1300. matics. 2015;56:254–261.
420. Wirken L, van Middendorp H, Hooghof CW, et al. The course and pre- 447. Ismail SY, Duerinckx N, van der Knoop MM, et al. Toward a conceptual-
dictors of health-related quality of life in living kidney donors: a systematic ization of the content of psychosocial screening in living organ donors:
review and meta-analysis. Am J Transplant. 2015;15:3041–3054. an ethical legal psychological aspects of transplantation consensus.
421. The Declaration of Istanbul on organ trafficking and transplant tourism. Transplantation. 2015;99:2413–2421.
Transplantation 2008;86:1013–1018. 448. Fonouni H, Mehrabi A, Golriz M, et al. Comparison of the laparoscopic
422. Thys K, Schwering KL, Siebelink M, et al. Psychosocial impact of pediat- versus open live donor nephrectomy: an overview of surgical complica-
ric living-donor kidney and liver transplantation on recipients, donors, tions and outcome. Langenbecks Arch Surg. 2014;399:543–551.
and the family: a systematic review. Transpl Int. 2015;28:270–280. 449. Liu N, Wazir R, Wang J, et al. Maximizing the donor pool: left versus right
423. Tong A, Chapman JR, Wong G, et al. The motivations and experiences laparoscopic live donor nephrectomy—systematic review and meta-
of living kidney donors: a thematic synthesis. Am J Kidney Dis. 2012; analysis. Int Urol Nephrol. 2014;46:1511–1519.
60:15–26. 450. Wilson CH, Sanni A, Rix DA, et al. Laparoscopic versus open nephrectomy
424. Jacobs CL, Gross CR, Messersmith EE, et al. Emotional and finan- for live kidney donors. Cochrane Database Syst Rev. 2011:CD006124.
cial experiences of kidney donors over the past 50 Years: The RELIVE 451. Yuan H, Liu L, Zheng S, et al. The safety and efficacy of laparoscopic do-
study. Clin J Am Soc Nephrol. 2015;10:2221–2231. nor nephrectomy for renal transplantation: an updated meta-analysis.
425. Clemens KK, Thiessen-Philbrook H, Parikh CR, et al. Psychosocial Transplant Proc. 2013;45:65–76.
health of living kidney donors: a systematic review. Am J Transplant. 452. Tanaka M, Ono Y, Matsuda T, et al. Guidelines for urological laparoscopic
2006;6:2965–2977. surgery. Int J Urol. 2009;16:115–125.
426. Clarke KS, Klarenbach S, Vlaicu S, et al. The direct and indirect eco- 453. Gibbons N, Nicol D, CARI. The CARI guidelines. Surgical techniques in
nomic costs incurred by living kidney donors—a systematic review. living donor nephrectomy. Nephrology (Carlton). 2010;15(Suppl 1):S88–S95.
Nephrol Dial Transplant. 2006;21:1952–1960. 454. Dols LF, Kok NF, d'Ancona FC, et al. Randomized controlled trial com-
427. Rodrigue JR, Schold JD, Morrissey P, et al. Direct and indirect costs paring hand-assisted retroperitoneoscopic versus standard laparo-
following living kidney donation: findings from the KDOC study. Am J scopic donor nephrectomy. Transplantation. 2014;97:161–167.
Transplant. 2016;16:869–876. 455. Cohen AJ, Williams DS, Bohorquez H, et al. Robotic-assisted laparo-
428. Klarenbach S, Gill JS, Knoll G, et al. Economic consequences incurred scopic donor nephrectomy: decreasing length of stay. Ochsner J.
by living kidney donors: a Canadian multi-center prospective study. 2015;15:19–24.
Am J Transplant. 2014;14:916–922. 456. Laplace B, Ladriere M, Claudon M, et al. Robotic assisted laparoscopic
429. Rodrigue JR, Schold JD, Morrissey P, et al. Predonation direct and living donor nephrectomy: preoperative assessment and results of 100
indirect costs incurred by adults who donated a kidney: findings from cases. Prog Urol. 2014;24:288–293.
the KDOC study. Am J Transplant. 2015;15:2387–2393. 457. Tzvetanov I, Bejarano-Pineda L, Giulianotti PC, et al. State of the art of ro-
430. Delmonico FL, Martin D, Dominguez-Gil B, et al. Living and deceased botic surgery in organ transplantation. World J Surg. 2013;37:2791–2799.
organ donation should be financially neutral acts. Am J Transplant. 458. Kaouk JH, Khalifeh A, Laydner H, et al. Transvaginal hybrid natural orifice
2015;15:1187–1191. transluminal surgery robotic donor nephrectomy: first clinical application.
431. Sickand M, Cuerden MS, Klarenbach SW, et al. Reimbursing live Urology. 2012;80:1171–1175.
organ donors for incurred non-medical expenses: a global perspective 459. Alcaraz A, Musquera M, Peri L, et al. Feasibility of transvaginal natural
on policies and programs. Am J Transplant. 2009;9:2825–2836. orifice transluminal endoscopic surgery-assisted living donor nephrec-
432. Tushla L, Rudow DL, Milton J, et al. Living-donor kidney transplantation: tomy: is kidney vaginal delivery the approach of the future? Eur Urol.
reducing financial barriers to live kidney donation-recommendations from 2011;59:1019–1025.
a Consensus Conference. Clin J Am Soc Nephrol. 2015;10:1696–1702. 460. Kortram K, Ijzermans JN, Dor FJ. Perioperative events and complica-
433. Lacetera N, Macis M, Stith SS. Removing financial barriers to organ and tions in minimally invasive live donor nephrectomy: a systematic review
bone marrow donation: the effect of leave and tax legislation in the U.S. and meta-analysis. Transplantation. 2016;100:2264–2275.
J Health Econ. 2014;33:43–56. 461. Gupta A, Ahmed K, Kynaston HG, et al. Laparoendoscopic single-site
434. Boyarsky BJ, Massie AB, Alejo JL, et al. Experiences obtaining insurance donor nephrectomy (LESS-DN) versus standard laparoscopic donor ne-
after live kidney donation. Am J Transplant. 2014;14:2168–2172. phrectomy. Cochrane Database Syst Rev. 2016:CD010850.
435. Yang RC, Thiessen-Philbrook H, Klarenbach S, et al. Insurability of living
462. Khalil A, Mujtaba MA, Taber TE, et al. Trends and outcomes in right vs.
organ donors: a systematic review. Am J Transplant. 2007;7:1542–1551.
left living donor nephrectomy: an analysis of the OPTN/UNOS database
436. Yang RC, Young A, Nevis IF, et al. Life insurance for living kidney do-
of donor and recipient outcomes—should we be doing more right-sided
nors: a Canadian undercover investigation. Am J Transplant. 2009;9:
nephrectomies? Clin Transplant. 2016;30:145–153.
1585–1590.
463. Dols LF, Kok NF, Alwayn IP, et al. Laparoscopic donor nephrectomy: a
437. Mittelman M, Thiessen C, Chon WJ, et al. Miscommunicating NOTA can
plea for the right-sided approach. Transplantation. 2009;87:745–750.
be costly to living donors. Am J Transplant. 2017;17:578–580.
438. American Society of Transplantation (AST). Live Donor Financial Toolkit. 464. Klop KW, Kok NF, Dols LF, et al. Can right-sided hand-assisted
Available at: https://www.myast.org/patient-information/live-donor- retroperitoneoscopic donor nephrectomy be advocated above standard
toolkit. (Accessed: September 7, 2016). laparoscopic donor nephrectomy: a randomized pilot study. Transpl Int.
439. Frade IC, Fonseca I, Dias L, et al. Impact assessment in living kidney do- 2014;27:162–169.
nation: psychosocial aspects in the donor. Transplant Proc. 2008;40: 465. Apisarnthanarak P, Suvannarerg V, Muangsomboon K, et al. Renal vas-
677–681. cular variants in living related renal donors: evaluation with CT angiogra-
440. Giessing M, Reuter S, Schönberger B, et al. Quality of life of living kidney phy. J Med Assoc Thai. 2012;95:941–948.
donors in Germany: a survey with the Validated Short Form-36 and 466. Roza AM, Perloff LJ, Naji A, et al. Living-related donors with bilateral mul-
Giessen Subjective Complaints List-24 questionnaires. Transplantation. tiple renal arteries. A twenty-year experience. Transplantation. 1989;47:
2004;78:864–872. 397–399.
C.Agnello SE 0322
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 326 of 569 PageID #:
S104 Transplantation ■ August 2017 ■ Volume 101 ■ Number 8S 520 www.transplantjournal.com
467. Flechner SM, Sandler CM, Houston GK, et al. 100 living-related kidney 491. Kumar K, King EA, Muzaale AD, et al. A smartphone app for increasing
donor evaluations using digital subtraction angiography. Transplantation. live organ donation. Am J Transplant. 2016;16:3548–3553.
1985;40:675–678. 492. Erickson J, Barbero R, Brewster M. A call to action to help reduce the
468. Ahmadi AR, Lafranca JA, Claessens LA, et al. Shifting paradigms in eligi- waiting list for organ transplants. 2016. Available at: https://www.
bility criteria for live kidney donation: a systematic review. Kidney Int. whitehouse.gov/blog/2016/09/01/call-action-help-reduce-waiting-list-
2015;87:31–45. organ-transplants. (Accessed: September 7, 2016).
469. Friedman AL, Peters TG, Ratner LE. Regulatory failure contributing to 493. Allen MB, Reese PP. The ethics of promoting living kidney donation using
deaths of live kidney donors. Am J Transplant. 2012;12:829–834. nonargumentative influence: applications, concerns, and future direc-
470. Friedman AL, Peters TG, Jones KW, et al. Fatal and nonfatal hemor- tions. Am J Transplant. 2016;16:3378–3384.
rhagic complications of living kidney donation. Ann Surg. 2006;243: 494. Wright L, Faith K, Richardson R, et al. Ethical guidelines for the evaluation
126–130. of living organ donors. Can J Surg. 2004;47:408–413.
471. Janki S, Verver D, Klop KW, et al. Vascular management during live donor 495. Frunza M, Van Assche K, Lennerling A, et al. Dealing With public solicita-
nephrectomy: an online survey among transplant surgeons. Am J Trans- tion of organs from living donors—an ELPAT view. Transplantation.
plant. 2015;15:1701–1707. 2015;99:2210–2214.
472. Serrano OK, Bangdiwala AS, Vock DM, et al. Defining the tipping point in 496. Wright L. Ethical controversies in public solicitations for organs. Trans-
surgical performance for laparoscopic donor nephrectomy among trans- plant Rev (Orlando). 2008;22:184–186.
plant surgery fellows: a risk-adjusted cumulative summation learning 497. Neidich EM, Neidich AB, Cooper JT, et al. The ethical complexities of on-
curve analysis. Am J Transplant. 2017;17:1868–1878. line organ solicitation via donor-patient websites: avoiding the “beauty
473. European Union. Toolbox Living Kidney Donation. Developed by experts of contest.” Am J Transplant. 2012;12:43–47.
the working group on living donation nominated by their National Competent 498. International Summit on Transplant Tourism and Organ Trafficking. The
Authorities (CAs) established by Directive 2010/53/EU)]. 2014. Available at: Declaration of Istanbul on organ trafficking and transplant tourism. Kid-
http://ec.europa.eu/health/blood_tissues_organs/docs/eutoolbox_living_ ney Int 2008;74:854–859.
kidney_donation_en.pdf. (Accessed: September 7, 2016). 499. Andrews PA, Burnapp L, Manas D, et al. Summary of the British Trans-
474. Lopp L. Regulations Regarding Living Organ Donation in Europe. Possi- plantation Society/Renal Association U.K. guidelines for living donor kid-
bilities of Harmonisation. Springer-Verlag Berlin Heidelberg; 2013. ney transplantation. Transplantation. 2012;93:666–673.
475. Lennerling A, Lovén C, Dor FJ, et al. Living organ donation practices in 500. Hays R, Rodrigue JR, Cohen D, et al. Financial neutrality for living organ
Europe—results from an online survey. Transpl Int. 2013;26:145–153. donors: reasoning, rationale, definitions, and implementation strategies.
476. Thys K, Van Assche K, Nobile H, et al. Could minors be living kidney do- Am J Transplant. 2016;16:1973–1981.
nors? A systematic review of guidelines, position papers and reports. 501. NOTA. National Organ Transplant Act. 42 U.S.C. § 273 §274. 1984.
Transpl Int. 2013;26:949–960. https://history.nih.gov/research/downloads/PL98-507.pdf. Accessed
477. Van Assche K, Genicot G, Sterckx S. Living organ procurement from the January 24, 2017.
mentally incompetent: the need for more appropriate guidelines. Bioeth- 502. LaPointe Rudow D, Cohen D. Practical approaches to mitigating eco-
ics. 2014;28:101–109. nomic barriers to living kidney donation for patients and programs. Curr
478. Veatch R. Transplantation Ethics. Chapter 12: Live Donor Transplant. Transpl Rep. 2017;4:24–31.
Georgetown University Press; 2000. 503. Radio New Zealand. New law gives financial assistance to organ donors.
479. Tenenbaum EM. Bartering for a compatible kidney using your incompat- http://www.radionz.co.nz/news/political/319407/new-law-gives-finan-
ible, live kidney donor: legal and ethical issues related to kidney chains. cial-assistance-to-organ-donors. (Accessed on Jan 14, 2017).
Am J Law Med. 2016;42:129–169. 504. American Society of Transplant Surgeons. Lost Wages Reimburse-
480. Tong A, Ralph A, Chapman JR, et al. Public attitudes and beliefs about ment for Living Organ Donors Trial Announced. https://asts.org/news-
and-publications/asts-news/article/2016/12/21/lost-wages-reim-
living kidney donation: focus group study. Transplantation. 2014;97:
bursement-for-living-organ-donors-trial-announced#WHqB1H05BQp.
977–985.
(Accessed January 14, 2017).
481. Young A, Karpinski M, Treleaven D, et al. Differences in tolerance for
505. Gaston RS, Danovitch GM, Epstein RA, et al. Limiting financial disincen-
health risk to the living donor among potential donors, recipients, and
tives in live organ donation: a rational solution to the kidney shortage. Am
transplant professionals. Kidney Int. 2008;73:1159–1166.
J Transplant. 2006;6:2548–2555.
482. Rodrigue JR, Cornell DL, Kaplan B, et al. Patients' willingness to talk to
506. Joshi S, Kupin W. Reciprocating living kidney donor generosity: tax
others about living kidney donation. Prog Transplant. 2008;18:25–31.
credits, health insurance and an outcomes registry. Clin Kidney J.
483. Waterman AD, Morgievich M, Cohen DJ, et al. Living donor kidney trans-
2016;9:168–171.
plantation: Improving education outside of transplant centers about live
507. Congressional Research Service. Summaries for the Living Donor Pro-
donor transplantation—recommendations from a consensus confer-
tection Act of 2016. Available at: https://www.govtrack.us/congress/
ence. Clin J Am Soc Nephrol. 2015;10:1659–1669. bills/114/hr4616/summary. (Accessed: September 7, 2016).
484. OPTN (Organ Procurement and Transplantation Network)/UNOS (United 508. Gill JS, Delmonico F, Klarenbach S, et al. Providing coverage for the
Network for Organ Sharing): OPTN 2015 Strategic Plan. Available unique lifelong health care needs of living kidney donors within the frame-
at: http://optn.transplant.hrsa.gov/governance/strategic-plan/. (Accessed: work of financial neutrality. Am J Transplant. 2017;17:1176–1181.
September 7, 2016).
510. Matas AJ. The rationale for incentives for living donors: an international
485. Taylor M. White House gets major commitments on organ transplants,
perspective? Curr Transpl Rep. 2015;2:44–51.
donations. June 13, 2016. Available at: http://medcitynews.com/2016/
511. Wright L, Anstey A. Contact Between Living Anonymous Donors and
06/white-house-organ-transplants/. (Accessed: September 7, 2016). Recipients: Ethical Issues. Ethical, Legal and Psychological Aspects
486. Garonzik-Wang JM, Berger JC, Ros RL, et al. Live donor champion: find- of Transplantation. Global Issues, Local Solutions. (Weimar W, Bos MA,
ing live kidney donors by separating the advocate from the patient. van Busschbach JJ: eds.). Lengerich, Germany: Pabst Publishers; 2014.
Transplantation. 2012;93:1147–1150.
512. OPTN (Organ Procurement and Transplantation Network)/UNOS (United
487. Rodrigue JR, Pavlakis M, Egbuna O, et al. The “House Calls” trial: a Network for Organ Sharing). OPTN Policies, Policy 8: Allocation of Kid-
randomized controlled trial to reduce racial disparities in live donor neys. Available at: http://optn.transplant.hrsa.gov/governance/policies.
kidney transplantation: rationale and design. Contemp Clin Trials. (Accessed: June 28, 2017).
2012;33:811–818. 513. Muzaale AD, Massie AB, Kucirka LM, et al. Outcomes of live kidney
488. Rodrigue JR, Cornell DL, Lin JK, et al. Increasing live donor kidney trans- donors who develop end-stage renal disease. Transplantation. 2016;
plantation: a randomized controlled trial of a home-based educational in- 100:1306–1312.
tervention. Am J Transplant. 2007;7:394–401. 514. Potluri V, Harhay MN, Wilson FP, et al. Kidney transplant outcomes for
489. Ismail SY, Luchtenburg AE, Timman R, et al. Home-based family inter- prior living organ donors. J Am Soc Nephrol. 2015;26:1188–1194.
vention increases knowledge, communication and living donation rates: 515. Stewart DE, Kucheryavaya AY, Klassen DK, et al. Changes in deceased
a randomized controlled trial. Am J Transplant. 2014;14:1862–1869. donor kidney transplantation one year after KAS implementation. Am J
490. Waterman AD, Robbins ML, Peipert JD. Educating prospective kidney Transplant. 2016;16:1834–1847.
transplant recipients and living donors about living donation: practical 516. Wainright JL, Klassen DK, Kucheryavaya AY, et al. Delays in prior living
and theoretical recommendations for increasing living donation rates. kidney donors receiving priority on the transplant waiting list. Clin J Am
Curr Transplant Rep. 2016;3:1–9. Soc Nephrol. 2016;11:2047–2052.
C.Agnello SE 0323
Case 2:24-cr-00366-NJC
© 2017 Wolters Kluwer
Document 24-1 Filed 03/11/26 Page 327 of 569 PageIDS105
KDIGO Living Kidney Donor Work Group
#:
521
517. Lavee J, Ashkenazi T, Gurman G, et al. A new law for allocation of donor 528. Weng FL, Reese PP, Waterman AD, et al. Health care follow-up by live
organs in Israel. Lancet. 2010;375:1131–1133. kidney donors more than three yr post-nephrectomy. Clin Transplant.
518. Lavee J, Ashkenazi T, Stoler A, et al. Preliminary marked increase 2012;26:E300–E306.
in the national organ donation rate in Israel following implementa- 529. Reith P. Adapting the selective periodic health exam to a college-aged
tion of a new organ transplantation law. Am J Transplant. 2013;13: population. Joint American Preventive Services Task Force. Canadian Task
780–785. Force on Health Care Screening. J Am Coll Health. 1989;38:109–113.
519. Tumin M, Rasiah R, Noh A, et al. Living kidney donation: the importance 530. Schold JD, Buccini LD, Rodrigue JR, et al. Critical factors associated
of public education. Clin Transplant. 2014;28:423–427. with missing follow-up data for living kidney donors in the United
520. Salomon DR, Langnas AN, Reed AI, et al. AST/ASTS workshop on in- States. Am J Transplant. 2015;15:2394–2403.
creasing organ donation in the United States: creating an “arc of change” 531. Ommen ES, LaPointe Rudow D, Medapalli RK, et al. When good inten-
from removing disincentives to testing incentives. Am J Transplant. tions are not enough: obtaining follow-up data in living kidney donors.
2015;15:1173–1179. Am J Transplant. 2011;11:2575–2581.
521. Tong A, Chapman JR, Wong G, et al. Perspectives of transplant 532. Davis CL. Living kidney donor follow-up: state-of-the-art and future di-
physicians and surgeons on reimbursement, compensation, and rections. Adv Chronic Kidney Dis. 2012;19:207–211.
incentives for living kidney donors. Am J Kidney Dis. 2014;64: 533. Casagrande LH, Collins S, Warren AT, et al. Lack of health insurance in
622–632. living kidney donors. Clin Transplant. 2012;26:E101–E104.
522. Mandelbrot DA, Pavlakis M, Karp SJ, et al. Practices and barriers in long- 534. Rodrigue JR, Fleishman A. Health insurance trends in United States living
term living kidney donor follow-up: a survey of U.S. transplant centers. kidney donors (2004 to 2015). Am J Transplant. 2016;16:3504–3511.
Transplantation. 2009;88:855–860. 535. Wainright J, McBride M, Dew MA, et al. Follow-up reporting for living
523. Leichtman A, Abecassis M, Barr M, et al. Living kidney donor follow-up: kidney donors. Abstr 195. Am J Transplant. 2013;13:90.
state-of-the-art and future directions, conference summary and recom- 536. Keshvani N, Feurer ID, Rumbaugh E, et al. Evaluating the Impact
mendations. Am J Transplant. 2011;11:2561–2568. of performance improvement initiatives on transplant center reporting
524. Van Assche K, Sterckx S, Lennerling A, et al. The relevance of Directive compliance and patient follow-up after living kidney donation. Am J
2010/53/EU for living organ donation practice: an ELPAT view. Trans- Transplant. 2015;15:2126–2135.
plantation. 2015;99:2215–2222. 537. Scientific Registry of Transplant Recipients. The Living Donor Collective:
525. OPTN/UNOS Living Donor Committee. Procedures to collect post- SRTR to Launch a Pilot Project to Create a Registry of Living Donors.
donation follow-up data from living donors. Available at: https://optn. https://www.srtr.org/news-media/news/news-items/news/. (Accessed
transplant.hrsa.gov/resources/guidance/procedures-to-collect-post-donation- June 28, 2017).
follow-up-data-from-living-donors/. (Accessed: Septebmer 7, 2015). 538. Lentine KL, Segev DL. Better understanding live donor risk through big
526. Litwin MS. Editorial comment: the psychosocial impact of donating a data. Clin J Am Soc Nephrol. 2013;8:1645–1647.
kidney. J Urol. 1997;157:1600–1601. 539. Kulkarni S, Thiessen C, Formica RN, et al. The long-term follow-up
527. Manyalich M, Menjivar A, Yucetin L, et al. Living donor psychosocial and support for living organ donors: A center-based initiative
assessment/follow-up practices in the partners' countries of the ELIPSY founded on developing a community of living donors. Am J Transplant.
project. Transplant Proc. 2012;44:2246–2249. 2016;16:3385-3391.
C.Agnello SE 0324
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 328 of 569 PageID #:
522
EXHIBIT M
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0325
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 329 of 569 PageID #:
523
SEGUNDA OPINIÓN BOOK ONLINE
What Is the Life Expectancy
of a Person on Kidney
Dialysis?
H O M E . W H AT I S T H E L I F E E X P EC TA N C Y O F A P E R S O N O N K I D N E Y
D I A LY S I S ?
C.Agnello SE 0326
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 330 of 569 PageID #:
524
July 14, 2025 by admin
If you or someone you care about is facing kidney dialysis, this question is
probably weighing heavily on your mind. It’s completely natural to want to
understand what lies ahead, and any kidney specialist will tell you that while
the statistics provide a framework, every person’s situation is unique. The
reality is that kidney dialysis has helped millions of people live longer, more
fulfilling lives, though life expectancy depends on many individual factors.
Understanding the Numbers
The statistics around dialysis life expectancy can seem overwhelming at first.
According to recent data, the average five-year survival rate for dialysis
patients is approximately 35-40%. This means that about 4 out of 10 people
on dialysis are still alive five years after starting treatment.
C.Agnello SE 0327
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 331 of 569 PageID #:
525
Age plays a significant role in these statistics. Younger patients typically have
much better outcomes than older patients. For instance, someone in their
30s starting dialysis has a very different prognosis than someone in their 80s.
Age Makes a Substantial
Difference
Younger patients on dialysis often have survival rates that are much more
encouraging. People under 45 who start dialysis have a five-year survival rate
of about 85%. This drops to around 60% for those between 45-64 and
continues to decline with advancing age.
This doesn’t mean older patients can’t do well on dialysis—many do. But it
does highlight why your kidney specialist will consider your age, along with
other factors, when discussing your prognosis and treatment options.
Other Health Conditions
Impact Outcomes
Your overall health status when starting dialysis significantly affects your life
expectancy. Diabetes and heart disease are the two most common
conditions that accompany kidney failure, and both can complicate your
prognosis.
People with diabetes who require dialysis typically have shorter life
expectancies than those without diabetes. Similarly, existing heart problems
can make dialysis more challenging and affect long-term outcomes.
However, proper management of these conditions can improve your
prognosis substantially.
C.Agnello SE 0328
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 332 of 569 PageID #:
Type of Dialysis Treatment
526
Matters
There are two main types of dialysis: hemodialysis and peritoneal dialysis.
Hemodialysis is typically performed at a dialysis center three times per week,
while peritoneal dialysis can often be done at home daily.
Some studies suggest that peritoneal dialysis may offer survival advantages,
particularly in the first few years of treatment. However, the best type of
kidney dialysis for you depends on your specific medical situation, lifestyle,
and personal preferences.
Quality of Life Considerations
While survival statistics are important, quality of life is equally significant.
Many people on dialysis continue to work, travel, and maintain active social
lives. The key is finding the right balance between treatment and living your
life.
The Importance of Compliance
One of the biggest factors affecting life expectancy on dialysis is how well
you follow your treatment plan. This includes showing up for all scheduled
dialysis sessions, taking prescribed medications, and following dietary
restrictions.
Skipping dialysis sessions or not following your fluid restrictions can lead to
serious complications and a shorter life expectancy. Your kidney specialist
and dialysis team will work with you to make compliance as manageable as
possible.
C.Agnello SE 0329
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 333 of 569 PageID #:
527
Transplant as a Game Changer
For many people, a kidney transplant represents the best long-term option.
The life expectancy for someone with a successful kidney transplant is
significantly better than staying on dialysis long-term.
However, not everyone is a candidate for transplant, and the waiting list for
donor kidneys can be long. Your kidney specialist will evaluate whether you’re
a good transplant candidate and help you navigate the process if appropriate.
Lifestyle Factors That Help
Several lifestyle factors can improve your outcomes on dialysis. Maintaining
good nutrition, staying as active as possible, managing stress, and keeping up
with preventive medical care all contribute to better health and longer life
expectancy.
Regular exercise, performed within the limits set by your healthcare team, can
improve your energy levels and overall health. Mental health support is also
crucial, as depression and anxiety are common among dialysis patients and
can affect treatment outcomes.
The Role of Your Healthcare
Team
Your kidney specialist and dialysis team play crucial roles in your long-term
success. Regular monitoring, adjusting treatment as needed, and addressing
complications early all contribute to better outcomes.
C.Agnello SE 0330
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 334 of 569 PageID #:
528
Do not hesitate to ask questions about your treatment or express concerns
about how you’re feeling. Open communication with your healthcare team is
essential for optimizing your care.
What To Expect
While facing kidney dialysis can feel overwhelming, remember that treatment
continues to improve. New technologies, better understanding of patient
needs, and improved medications are constantly enhancing outcomes for
dialysis patients.
If you have questions about kidney dialysis, schedule a consultation with our
kidney doctor today.
Dialysis
dialysis, dialysis faqs, quality of life
Does Hypertension Cause Headaches?
Can Acute Kidney Injuries Lead to Chronic Disease?
Recent Posts
How End-Stage Renal Disease Affects the Entire Body
Causes of Proteinuria: When Should You Be Concerned?
Can Exercise Lower Blood Pressure?
Lifestyle Changes That Help Manage Diabetes Long-Term
Can Acute Kidney Injuries Lead to Chronic Disease?
C.Agnello SE 0331
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 335 of 569 PageID #:
529
Beverly Hills
310.550.6240
50 North La Cienega Boulevard, Suite 310,
Beverly Hills, CA 90211
Follow Us
C.Agnello SE 0332
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 336 of 569 PageID #:
530
P R I VACY P O L I CY | T E R M S & CO N D I T I O N S | H I PA A P R I VACY P O L I CY | CO N TAC T U S
CO PY R I G H T © 2 02 6 V I C TO R G U R A , M . D.
C.Agnello SE 0333
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 337 of 569 PageID #:
531
EXHIBIT N
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0334
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 338 of 569 PageID #:
532
C.Agnello SE 0335
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 339 of 569 PageID #:
533
C.Agnello SE 0336
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 340 of 569 PageID #:
534
C.Agnello SE 0337
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 341 of 569 PageID #:
535
C.Agnello SE 0338
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 342 of 569 PageID #:
536
C.Agnello SE 0339
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 343 of 569 PageID #:
537
C.Agnello SE 0340
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 344 of 569 PageID #:
538
C.Agnello SE 0341
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 345 of 569 PageID #:
539
C.Agnello SE 0342
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 346 of 569 PageID #:
540
EXHIBIT O
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0343
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 347 of 569 PageID #:
541
COMMENTARY
MISSISSIPPI DECISION EXCHANGING PAROLE FOR KIDNEY DONATION
The Mississippi Decision Exchanging Parole for Kidney Donation:
Is This the Beginning of Change for Altruistic-Based Human Organ
Donation Policy in the United States?
Christopher M. Burkle, MD, JD
G overnor Haley Barbour’s recent decision to indefinite-
ly suspend the life sentences of 2 Mississippi sisters
convicted of a 1994 armed robbery drew considerable me-
able as to tissue compatibility or other potential limitations
to the prospect of a medically optimized transplant. Al-
though the governor has yet to publically announce whether
dia attention worldwide.1-3 Jamie and Gladys Scott were he will require the sisters to return to prison in the event of
reported to be traveling in a car with 2 men. When Jamie a failure to proceed with the conditioned kidney transplant,
feigned illness, the driver of the car pulled over to the side NAACP (National Association for the Advancement of Col-
of the road, at which point 3 men who had been following ored People) President Benjamin Jealous stated that, during
in a car behind robbed the 2 men at gunpoint. The 3 men his meeting with the governor, he was told that Gladys will
who were arrested along with the Scott sisters pled guilty not go back to prison if her kidney is not a match.5
and were sentenced to shorter prison terms in exchange for The purpose of this article is to evaluate the recent de-
testifying against Jamie and Gladys. That the women were cision made by Mississippi state officials in the context
black, living in the South, and sentenced to what many of current organ transplant legislation. A brief description
thought a harsh prison term for a crime netting a mere $11 of the theoretical concepts that involve criminal punish-
prompted critical social examination. Health care profes- ment and parole affords a better appreciation of whether
sionals and bioethicists alike were further drawn to an ele- the Mississippi decision aligns with the traditional goals
ment of Governor Barbour’s decision that crossed into the established by the criminal justice system. The crimi-
realm of long-standing organ transplant policy. At the time nal justice market and the market for human organs are
of the suspension, Jamie was undergoing dialysis treat- compared. Examining prior legislative efforts assists in
ment at an annual cost to the state of $200,000 and was unmasking the potential conflict introduced by combined
scheduled for early release because of her need for a kid- decisions involving the criminal justice system and human
ney transplant. According to the governor’s office, in her organ transplant donation. Finally, this article argues that,
petition to the Mississippi parole board for early release in although the State of Mississippi decision, and any further
2010, Gladys voluntarily offered to donate her kidney to public reaction that follows, may offer some preliminary
her incarcerated sister.4 The governor explained that, after insight as to a willingness to deviate from purely altruis-
the sisters’ request for early release, the Mississippi parole tic motives regulating solid organ donation in the United
board recommended against either a pardon or a commuted States, it will likely fail as the first true test of a criterion
sentence. On further review of the sisters’case, the board for change.
determined that the Scotts were no longer a threat to society
and granted an indefinite suspension of their sentences.4 THEORIES OF CRIMINAL PUNISHMENT
Gladys’ indefinite suspension, which state officials de- Theories justifying punishment of criminal activity fall into
scribe as equivalent to parole, requires her to donate her kid- 2 broad categories of thought: retribution and utilitarian.6
ney to her 36-year-old sister within 1 year after her release. Retributivists base their rationalization for punishment on
The governor reportedly has said that the kidney donation the principle that people who commit crimes deserve to be
“should be scheduled with urgency.”4 At the time of the punished (“an eye for an eye”).6,7 It is a backward look-
sisters’ release from the Mississippi Department of Correc- ing approach of punishing what has already been commit-
tions facility on January 7, 2011, no information was avail- ted.6 The goal of retribution is to counter the advantage the
criminal has seized by refusing to live within the laws of
society.6 Popularized by Immanuel Kant during the 18th
From the Department of Anesthesiology, Mayo Clinic, Rochester, MN.
century, retribution notions strongly influenced the draft-
An earlier version of this article appeared Online First.
ers of the US Constitution.6,7 With the retribution theory,
Individual reprints of this article are not available. Address correspondence
to Christopher M. Burkle, MD, JD, Department of Anesthesiology, Mayo Clinic,
behavior while incarcerated, future risk of criminal acts,
200 First St SW, Rochester, MN 55905 (burkle.christopher@mayo.edu). and plans for activities after release are all made irrelevant
© 2011 Mayo Foundation for Medical Education and Research to the choice of punishment.7 Retribution, or “just des-
414 .BZP$MJO1SPDr.BZ rEPJNDQrXXXNBZPDMJOJDQSPDFFEJOHTDPN
C.Agnello
For personal use. Mass reproduce only SE 0344from a
with permission Mayo Clinic Proceedings.
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 348 of 569 PageID #:
542
MISSISSIPPI DECISION EXCHANGING PAROLE FOR KIDNEY DONATION
serts,” was a popular method of criminal punishment until are either plentiful or regenerated with reasonable ease
the 1980s, as reflected by lengthy prison terms and limited (eg, hair, sperm, eggs, and blood). Blood donation must
chance for parole.7 On the basis of a backward looking ap- occur on a volunteer and uncompensated basis, whereas
proach model, retribution could place a temporal length on sperm and egg donors may receive payment in exchange
punishment without the need for future term adjustment for their product. Interestingly, some egg and sperm do-
through parole processes. nors may benefit from a graduated payment system based
In contrast to retribution bases for criminal punishment, on intelligence and beauty traits.9
utilitarian theories use a forward looking approach.6 Utili- The human organ market involves a product that
tarians validate the need for punishment by referring to the is scarce and vital to continued life. As such, it is more
alleged benefits that accrue after implementation.6 Three regulated and therefore better described by closed market
fundamental paradigms are within the boundaries of utili- theories. The first piece of federal action impacting human
tarian punishment theory.6 General deterrence acts on the organ donation in the United States was the Uniform Ana-
assumption that a person’s awareness of the risk of pun- tomical Gift Act (UAGA) of 1968.8-10 Despite its title, the
ishment after a crime will reduce the likelihood that he or UAGA could not be classified as either an act or legisla-
she will commit a future crime. Incapacitation restricts a tion.11 Instead, it was meant to serve as a model on which
criminal’s ability to commit a future crime against society states could base their own statutes. Until that time, state
by removing him or her from the public forum. Finally, and laws varied in the handling of organ procurement prac-
perhaps of most interest to the public, the goal of utilitarian tices.11 Passage of the UAGA helped to reduce differences
theory is to use punishment as a means of reform. Simi- in state laws while simplifying the process with which
lar in some respect to utilitarian incapacitation concepts, people could become organ donors.9-11 Although the body
reform efforts act to protect the public by changing the of the text of the UAGA did not expressly address human
mindset of the criminal, rather than simply removing the organ sales, some have argued that the term HJGUused in its
criminal from the victim-rich environment. Because pun- title was intended to prohibit monetary or other types of
ishment works to mitigate the risk that the criminal pre- exchanges for organ donation.8,11 In 1987, the UAGA was
sents to society, utilitarian theory offers a better association amended to expressly prohibit the sale or purchase of hu-
with truncating prison terms through parole measures than man body organs removed after death but did not address
does its retribution counterpart.7 living organ donation.8,10,11 No similar commercial restric-
tion was addressed by the updated UAGA for living organ
MARKET CONCEPTS donor exchange.11 Unlike the earlier version of the UAGA
Market concepts have been used to describe both the crimi- that had been approved by all 50 states and the District of
nal justice sentencing system and human organ transplant Columbia, the 1987 UAGA has been adopted in only 26
programs.8,9 In her 2009 law review article, Lee9 explained states.11
how exchanges of guilty pleas for mitigated sentence terms After the antirejection drug cyclosporine was approved
could equate to market practices. Prosecutors are awarded by the US Food and Drug Administration in 1983, human
ease of conviction in return for proposing truncated sen- organ transplantation increased considerably.8,11-13 A more
tence terms. Criminals benefit from shorter incarceration equitable means of linking supply with demand for living
terms in exchange for giving up both their right to trial by organ donation was needed.8,11 The 1984 passage of the
jury and their constitutional protections involving self-in- National Organ Transplant Act (NOTA) was the first fed-
crimination. Lee9 classifies the criminal justice market as eral legislation promulgated to regulate human organ trans-
an “open” market because it allows for public oversight plants. The champion of the bill, Representative Al Gore,
and accountability. Because most judges and public pros- Jr, of Tennessee, initially considered that future incentives
ecutors who formulate terms of incarceration are voted into may be necessary if organ supplies based on altruistic dona-
office, the public may refuse to reelect them if dissatisfied tion alone were short of demand.11 However, during contin-
with their decisions. Criminal justice markets require less ued congressional debate over NOTA, fears that incentives
fixed regulatory oversight because they are visible, or open, may actually decrease organ supplies, lessen the quality of
to public scrutiny. the organs, and possibly exploit the poor led to the addi-
In contrast to the criminal justice sentencing market, tion of Section 301 to the bill.11 Labeled as “Prohibition of
the human body parts market often requires substantial Organ Purchases,” Section 301 made it “...unlawful for any
regulatory oversight.8,9 The degree of openness in the hu- person to knowingly acquire, receive, or otherwise transfer
man body market varies on the basis of the scarcity of the any human organ for WBMVBCMFDPOTJEFSBUJPO for use in hu-
body part being exchanged.9 Some of the more common man transplantation if the transfer affects interstate com-
exchanges involving human body parts include those that merce [italics added].”11,14 With passage of NOTA, federal
.BZP$MJO1SPDr.BZ rEPJNDQrXXXNBZPDMJOJDQSPDFFEJOHTDPN 415
C.Agnello
For personal use. Mass reproduce only with SE 0345 from a
permission Mayo Clinic Proceedings.
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 349 of 569 PageID #:
543
MISSISSIPPI DECISION EXCHANGING PAROLE FOR KIDNEY DONATION
criminal legislation now exists that prohibits any exchange eligibility for parole or probation.9,16 Although the laws in
of living or deceased donor human organs for valuable the 9 states differ to a degree, they remain consistent by
consideration. authorizing castration only after criminal activity involving
some form of sexual victimization. Such a procedural pro-
RECENTLY PROPOSED LEGISLATION cess ensures a natural association between the crime and
In an attempt to increase the number of available human the punishment.9 Given that the proposed goal of castration
organs for transplant, South Carolina lawmakers intro- is to help protect society from future harms, this type of
duced Senate Bill 480 (SB 480) in 2007.9 The core of the punishment best falls within the framework established by
bill was to trim 180 days from a prisoner’s sentence in ex- utilitarian views.
change for donation of a kidney.9 Although SB 480 did not
move past initial legislative procedural barriers, its intro- WHY THE SCOTT SISTERS’ PAROLE ARRANGEMENT MAY FAIL
duction stimulates concern over possible conflicts that may In her 2009 writing, Lee9 argued that plea bargaining prac-
arise when attempts are made to mesh the criminal justice tices function under a market theory construct. Parole pro-
markets with the human body part markets. If SB 480 had cesses that truncate prison terms likely follow a similar
been passed by the South Carolina legislature, it likely market-based schema. Public officials regulate both initial
would have survived legal scrutiny inherent in a criminal sentencing decisions (plea bargaining) and eligibility for
justice sentencing open market concept. As the proponent early release (parole). Public satisfaction with government
of the bill, Senator Ralph Anderson worked to reassure the decisions that involve criminal incarceration is measured
public that government officials would ensure that prison- through voter actions. Like their plea bargaining counter-
ers’ decisions were voluntary and made only after receiving part, parole decisions that involve exchange of human or-
all the information they required.9 gans for transplant are likely legal under criminal justice
The barriers confronting the legitimacy of SB 480 re- standards.9 NOTA’s strict prohibition against a market ex-
sulted from its conflict with human organ market limi- change of human organs for valuable consideration is why
tations, rather than open market criminal justice restric- the Mississippi state government’s decision to truncate the
tions.9 As the language of NOTA’s legislation prescribes, sisters’ sentence terms in exchange for Gladys’ assurance
human organs may not be transferred in exchange for may fail to meet legal muster. Analogous to the arguments
valuable consideration. At its foundation, contract law presented during discussion of South Carolina’s failed
requires an exchange of “consideration,” or a promise to SB 480 legislation attempt, parole board decisions that
provide something of value to one party in exchange for involve a prisoner’s freedom from incarceration may be
his or her promise to provide something of value in re- equated to valuable consideration.
turn.15 In the case of SB 480, South Carolina government A further ethical blow to the state of Mississippi’s
officials proposed offering a 180-day reduction in sen- agreement with the Scott sisters arises from the lack of
tencing. In exchange, prisoners would be required to do- clear connection between the donation of a human body
nate a kidney. Although state officials were not suggest- part and the theoretical goals of criminal punishment and
ing tendering money as valuable consideration, they were parole. Although castration has been suggested to serve a
offering freedom or liberty from incarceration. As both utilitarian role of protecting society from a criminal’s ac-
the Fifth and Fourteenth Amendments of the US Consti- tions, no similar association can be drawn with the dona-
tution hold that liberty cannot be taken away without due tion of a kidney by Gladys.
process, there can be little doubt that liberty equates to The purpose of this article is not to offer my opinion
valuable consideration in a free society.9 In the context as to whether the current laws that restrict compensation
of a prison inmate, freedom from incarceration may be for donor organs should be amended. However, reactions
an especially important element of value.9 Although ex- of the public, bioethicists, and health care professionals to
changes of prison time for human organs may meet legal the decision by the governor’s office and the Mississippi
muster under criminal justice law open market sentenc- parole board may provide insight into society’s willingness
ing concepts, strict compliance with NOTA’s regulations to favor future legislation that allows “payment” for organ
would restrict such arrangements.9 donation. Many academics have written about the poten-
tial risks involved with compensation of donors through a
IN PLACE LEGISLATION: TRADING PRISON TIME FOR free market system.8,11 Examples of these concerns include
INVASION OF BODY coercion of donors, lack of adequate informed consent
Nine states have passed legislation that authorizes chemi- among donors, donors’ misrepresentation of the health of
cal or physical castration of convicted criminals.9,16 In most their potentially donated organs, the poor disproportionally
of those states, consent to castration impacts an offender’s donating to the rich in need of an organ, financial suffer-
416 .BZP$MJO1SPDr.BZ rEPJNDQrXXXNBZPDMJOJDQSPDFFEJOHTDPN
C.Agnello
For personal use. Mass reproduce only SE 0346from a
with permission Mayo Clinic Proceedings.
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 350 of 569 PageID #:
544
MISSISSIPPI DECISION EXCHANGING PAROLE FOR KIDNEY DONATION
ing of the poor donor with increased health costs, and the as a fiscally acceptable means of cutting future state in-
potential for a decrease in overall organs donated if those carceration costs. According to Mississippi Corrections
who would otherwise offer organs for altruistic reasons be- Commissioner Christopher Epps, the State of Mississippi
come disenchanted by the commercial nature of the mar- spent $50 million on inmate health care in 2010 alone.4
ket.11,17,18 Whether these are tangible risks or the product Given this annual expense, one could argue that the con-
of common myths further propagated by well-publicized ditional release of Gladys may serve a utilitarian purpose
stories in foreign countries of “organs for money” schemes by benefiting Mississippi’s populus through economic sav-
is a topic for separate discussion. Many have argued that a ings. With the threat of continued criminal activity abated
well-structured and supervised free market for organs may and the cost of continued confinement extreme, the ques-
offer an ethical and practical means of helping resolve the tion of whether the conditions placed on Gladys’ indefinite
ongoing shortage of available human body organs supplied suspension collide with transplant ethics may not be that
by altruistic donor pools.19-21 The conditions involved with important to the public.
the indefinite suspension of Gladys' prison term stimulate Time will tell whether it will be written that the gov-
concern that such an exchange of valuable consideration ernor’s office, the Mississippi State parole board, and
for consent to organ donation violates the restrictions im- the Scott sisters were instrumental in initiating change
posed by NOTA. to domestic human organ transplant policy. Although the
Although the Mississippi decision has the potential of unique aspects of this case may limit public debate on the
stirring public debate over the future viability of a struc- topic of nonaltruistic organ donation, others more closely
tured compensation exchange program for human organ associated with the ethical and administrative components
donation, the unique features of the Scott sisters’ case make of transplant medicine may argue the merits and future
it unlikely that any settled consensus will be met. Of note, impact of Mississippi’s decision for some time. Although
Gladys is said to have voluntarily offered to donate her kid- the true intent behind the decision to release Gladys from
ney to her sister Jamie. When describing her willingness to prison remains under debate, the condition requiring or-
donate her kidney to her sister after her release on January gan donation remains authenticated in the legal records
7, 2011, Gladys is reported to have said that “[the Gover- and history of the state of Mississippi. Individuals or state
nor] didn’t even have to put that in the order ‘cause I was authorities seeking to promote nonaltruistic organ dona-
going to do that anyway.’”22 Whether these reports are an tion policies will likely reference the Scott case as a posi-
accurate assessment of Gladys’ altruistic motives is not a tive or “shining” example of such a policy in action. In ad-
topic that I feel at liberty to question. dition, while appreciating the unique features of the Scott
Had the State of Mississippi initiated a negotiation that case, parties to future arrangements that involve solid or-
offered Gladys an indefinite suspension in exchange for a gan exchange may still benefit when studying the reaction
kidney donation, public reaction might be viewed as reflec- it caused, or did not cause, as they test the boundaries of
tive of acceptance or rejection of potentially coerced agree- change.
ments. Further limiting possible public outcry is that the
Scott sisters had already served 16 years for an $11 crime
and that the Mississippi parole board concluded that they REFERENCES
were no longer a threat to society. If instead Gladys had 1. Herbert B. For two sisters, the end of an ordeal. /FX:PSL5JNFT Decem-
recently been imprisoned and remained a danger to soci- ber 31, 2010. Web site. http://www.nytimes.com/2011/01/01/opinion/01herbert
.html?_r=1. Accessed March 24, 2011.
ety, the public’s response to her release could more clearly 2. In Miss. Sisters’ parole depends on kidney donation. "MM5IJOHT $PO
signal society’s willingness to accept the introduction of TJEFSFE NPR Web site. December 30, 2010. http://www.npr.org/2010/12/30
valuable consideration into transplant policy. Perhaps the /132488858/In-Miss-Sisters-Parole-Contingent-On-Kidney-Donation. Accessed
March 24, 2011.
greatest limitation in using the Scotts’ case as a test case 3. Gabbatt A. Sisters granted parole in return for kidney donation. Guardian.
stems from the fact that Gladys’ indefinite suspension may co.uk Web site. December 31, 2010. http://www.guardian.co.uk/world/2010/dec
in fact not truly be conditioned on her consent to donate a /31/mississippi-sisters-parole-kidney. Accessed March 24, 2011.
4. Social and political pressure brought about freedom for the Scott sisters?
kidney. Although the governor remains elusive in his an- &638FC Web site. December 30, 2010. http://www.blackwebportal.com/wire
swers as to what may occur if the Scott sisters are not an /DA.cfm?ArticleID=7515. Accessed March 24, 2011.
acceptable tissue match, NAACP reports suggest that the 5. Thompson K. ‘Conditioned on’ kidney donation, sisters’ prison release
prompts ethics debate. 8BTIJOHUPO1PTUWeb site. December 30, 2010. http://www
governor’s office had already decided early on to forgo any .washingtonpost.com/wp-dyn/content/article/2010/12/30/AR2010123002930
requirement that Gladys return to prison.5 .html?wprss=rss_nation. Accessed March 24, 2011.
With the Mississippi State government running at deficit 6. Dressler J. $BTFTBOE.BUFSJBMTPO$SJNJOBM-BX. 3rd ed. St. Paul, MN:
Thomson West; 2003.
levels, allowing the release of not only Jamie but also her 7. Burke PB. $VSSFOU *TTVFT JO 1BSPMF %FDJTJPONBLJOH 6OEFSTUBOEJOH
potential kidney transplant donor Gladys could be viewed UIF1BTU4IBQJOHUIF'VUVSF. Washington, DC: US Dept of Justice, National
.BZP$MJO1SPDr.BZ rEPJNDQrXXXNBZPDMJOJDQSPDFFEJOHTDPN 417
C.Agnello
For personal use. Mass reproduce only with SE 0347 from a
permission Mayo Clinic Proceedings.
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 351 of 569 PageID #:
545
MISSISSIPPI DECISION EXCHANGING PAROLE FOR KIDNEY DONATION
Institute of Corrections;1988. http://nicic.gov/pubs/pre/007017.pdf. Accessed 14. National Organ Transplantation Act. http://livingdonorassistance.org/
March 24, 2011. documents/NOTA.pdf. Accessed March 24, 2011.
8. Hughes JA. You get what you pay for?: Rethinking U.S. organ pro- 15. Knapp CL, Crystal NM, Prince HG. 3VMFTPG$POUSBDU-BX
curement policy in light of foreign models. 7BOEFSCJMU+5SBOTOBUJPOBM-BX New York, NY: Aspen Publishers; 2005.
2009;42:351-381. http://media.web.britannica.com/ebsco/pdf/603/36865603 16. Scott CL, Holmberg T. Castration of sex offenders: prisoners’ rights ver-
.pdf. Accessed March 24, 2011. sus public safety. +"N"DBE1TZDIJBUSZ-BX. 2003;31:502-509.
9. Lee EC. Trading kidney for prison time: when two contradictory legal 17. Goyal M, Mehta RL, Schneiderman LJ, Sehgal AR. Economic and health
traditions intersect, which one has the right-of-way? 6OJW4BO'SBODJTDP-BX consequences of selling a kidney in India. +".". 2002;288:1589-1593.
3FW. 2009;43:507-557. http://usf.usfca.edu/law/academic/journals/lawreview 18. Jha V. Paid transplants in India: the grim reality. /FQISPM %JBM5SBOT
/printissues/v43i3/Lee.pdf. Accessed March 24, 2011. QMBOU. 2004;19:541-543.
10. King PA, Areen J, Gostin LO. -BX .FEJDJOFBOE&UIJDT. New York, NY: 19. Halpern SD, Raz A, Kohn R, Rey M, Asch DA, Reese P. Regulated pay-
Foundation Press; 2006. ments for living kidney donation: an empirical assessment of the ethical con-
11. Satel S. 8IFO"MUSVJTN*TOU&OPVHI5IF$BTFGPS$PNQFOTBUJOH,JE cerns. "OO*OUFSO.FE. 2010;152:358-365.
OFZ%POPST Washington, DC: The AEI Press; 2008. http://www.sallysatelmd 20. Hippen BE. In defense of a regulated market in kidneys from living ven-
.com/html/aeibookflyer.pdf. Accessed March 24, 2011. dors. +.FE1IJMPT. 2005;30:593-626.
12. Linden PK. History of solid organ transplantation and organ donation. 21. Taylor JS. Black markets, transplant kidneys and interpersonal coercion.
$SJU$BSF$MJO. 2009;25:165-184, ix. +.FE&UIJDT. 2006;32:698-701.
13. Ruth RJ, Wyszewianski L, Campbell DA. The future of kidney trans- 22. Donate kidney—jailed Mississippi sisters freed. Nonprofit News Web site.
plantation: the effect of improvements in survival rate on the shortage of do- January 17, 2011. http://www.onlinecardonation.org/charitynews/archives/142.
nated kidneys. .FE$BSF. 1987;25:238-249. Accessed March 24, 2011.
418 .BZP$MJO1SPDr.BZ rEPJNDQrXXXNBZPDMJOJDQSPDFFEJOHTDPN
C.Agnello
For personal use. Mass reproduce only SE 0348from a
with permission Mayo Clinic Proceedings.
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 352 of 569 PageID #:
546
EXHIBIT P
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0349
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 353 of 569 PageID #:
547
AdADVERTISEMENT
removed.
Show details
LIVE Mickey Lolich dies at 85 Anthony Davis trade Savannah Guthrie’s mom Winter Olympics 2026
Trump administration
Women released from Mississippi prison make life in Florida
BY MELISSA NELSON GABRIEL
Updated 5:34 PM GMT-3, July 23, 2018
PENSACOLA, Fla. (AP) — Serving double life sentences for taking part in a 1993 armed robbery that netted
$11, sisters Jamie and Gladys Scott hit bottom at different points.
It happened to Gladys six months after she entered the Central Mississippi Correctional Facility in Pearl,
Mississippi, two months after she gave birth to a baby girl that she was not allowed to raise.
“I tried to commit suicide because it bothered me so bad. I fell into a bad depression. I cut myself with a razor
blade, but God wasn’t ready for me,” she said.
It happened to Jamie in 2003 when she learned her father died.
“I felt like something inside me died. I think he died of a broken heart because he couldn’t get us out of
prison,” she said. “I saved up pills because I wanted to end my life, I couldn’t see my life keep being in that
place.”
Guards found the pills and confiscated them during an unannounced search of her cell.
ADVERTISEMENT
This Month's Top Offers
360 PERFORMANCE
SAVINGS
• No fees
3.30
• No minimums
% • Open in about 5 min
APY
As of 01/08/2026 | Member FDIC OPEN ACCOUNT
360 CHECKING
Member FDIC
Earn a $250 bonus with 360
Checking. No fees, no OPEN ACCOUNT
minimums. Terms apply.
“I took that as a message from God that he didn’t want me to die,” she said.
Seven years after the Scott sisters made national headlines following then-Mississippi Gov. Haley Barbour’s
unusual agreement to release them from prison, the women have fought to build a life for themselves in
Pensacola.
C.Agnello SE 0350
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 354 of 569 PageID #:
It hasn’t been easy. 548
Barbour indefinitely suspended the sisters’ sentences on the condition that Gladys donate a kidney to Jamie,
who was on dialysis and in failing health. Legal scholars questioned whether Mississippi could put such
conditions on the sister’s release, but both sisters agreed to the deal.
The sisters’ original sentences drew widespread condemnation from Civil Rights leaders and others. The
women were 19 and 21 and had no prior criminal convictions when they were arrested and charged with
orchestrating the Christmas Eve armed robbery of two men in Forest, Mississippi.
Prosecutors said they led the men, who were hit on the back of their heads with shotguns, into an ambush.
Three male teenagers charged in the case testified against the sisters in exchange for lighter sentences.
ADVERTISEMENT
This Month's Top Offers
360 PERFORMANCE
SAVINGS
• No fees
3.30
• No minimums
% • Open in about 5 min
APY
As of 01/08/2026 | Member FDIC OPEN ACCOUNT
E*TRADE PREMIUM
SAVINGS
For a limited time, earn a
3.35
cash bonus up to $2,000.
% Terms apply.*
APY
Member FDIC GET STARTED
The sisters maintain their innocence and are seeking a full pardon from Mississippi Gov. Phil Bryant so they
can be released from parole requirements. Bryant has so far declined to issue pardons in the case.
The women moved to Pensacola after their release from prison because that is where their mother, Evelyn
Rasco, was living. Rasco died in 2013 at the age of 65 from diabetes and other health complications.
“You cannot measure a mother’s love. She did everything to fight for us, including letting her health go down.
When we came home, her health was already failing and she was tired. But the three years I had with her
were the best of my life,” Gladys said during a recent interview from her sister’s west Pensacola home.
Jamie has yet to receive her desperately needed kidney transplant and spends nearly four hours, three days a
week on dialysis.
She had lost 61 pounds following weight-loss surgery. She was also working and taking classes at Pensacola
State College.
Everything changed April 9, 2017, when an intoxicated driver struck the car she was driving and caused her to
crush her ankle while attempting to press the brakes to keep her car from spinning out of control.
A
D
V
C.Agnello SE 0351
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 355 of 569 PageID #:
549
E
R
T
IS
E
M
E
N
T
Surgeons amputated her right foot in late May after seven unsuccessful surgeries.
“It was a hard decision, and I wasn’t going to do it at first but Gladys started crying and told me that she
would rather have me here with one leg than not have me here at all. Eventually I knew it was what I had to do
so that I could live,” Jamie said.
The two sisters are incredibly close.
“I used to ask my mom whether we were twins because we had such a close connection,” Gladys said.
“People are always saying that when you see one of us, you see both us.”
After the amputation, Gladys took Jamie to a nail salon for a manicure.
The sisters laughed because the salon charged Jamie the same for manicuring one foot as for manicuring
both feet.
“They didn’t even give me a discount for having one foot,” Jamie said, laughing.
The sisters’ tight bond helped them make it through 16 years in prison. They shared a cell for much of the
first 10 years before the state of Mississippi ordered that relatives could not be housed together.
A
D
V
E
R
T
IS
E
M
E
N
T
In the seven years since their release, they have relied on each other like never before. Gladys now works full-
time as runner for the Michaels and Booth law firm.
C.Agnello SE 0352
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 356 of 569 PageID #:
550
“She is the only one who really knows what I have been through,” Gladys said. “We have seen things (in
prison) shouldn’t no one have to see.”
Gladys wakes up in the middle of the night with her inmate number — 19142 — going through her head.
“You don’t have a name when you are in there, just a number and sometimes you don’t believe it is real that
you are out. You think that if you close your eyes it will all go away,” she said.
Greater Little Rock Baptist Church Pastor Lonnie Wesley III has become close friends with Gladys and Jamie
in the last seven years.
A
D
V
E
R
T
IS
E
M
E
N
T
“They have taught me a lot about what the newly released from prison person goes through. People don’t
realize the stigma that they have to fight while simultaneously trying to play catch up,” he said.
Despite all the women have been through, “not one time have they complained,” Wesley said.
“Our prayer is that they won’t let the fight get the best of them and they can keep on fighting,” he said.
Although Mississippi prison officials said Gladys was a match to donate a kidney to Jamie, the Mayo Clinic in
Jacksonville needs to do more tests. If Gladys is a compatible donor, the women will have to spend weeks in
Jacksonville before and after the transplant. Because of her amputated foot, Jamie will not be able stay
without someone to help her.
The sisters are worried about the expenses associated with the trip and about whether their parole
conditions with the state of Mississippi will allow them to be away from home for so long.
“It’s discouraging because I will have to stay in a hotel there for a long time even after I am released from the
hospital,” Jamie said. “And we have to be able to leave here very quickly when the time comes for the
transplant.”
Jamie’s son, 24-year-old Richard Scott, is close with both women. Richard has watched his mother and aunt
try to adapt after 16 years behind bars.
“You cannot get back that time that was lost. When I was younger, it created some anger in me,” said Richard,
an Army soldier who will deploy to Afghanistan later this year. “If you stay back on grudges, you are never
C.Agnello SE 0353
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 357 of 569 PageID #:
going to move forward.” 551
He laughs about the women’s unfamiliarity with cellphones and other technology. The trio joke about how he
tried to Face Time them on a recent deployment.
“You could just see Gladys’ nose,” he laughed.
The women collaborated on the 2016 book, “The Scott Sisters: Revealing the Truth, Exposing Injustice and
Trusting God.” They donated all proceeds to help women released from prison adapt to life outside.
“It was scary reliving some of the things we saw in prison to write the book, but it was like you releasing
something with every chapter. It was therapeutic,” Gladys said.
The state of Mississippi prohibited the women from traveling to some book signings in that state because of
the conditions of their parole.
“We are not through with our fight,” said Jamie, who added that the parole stipulations mean that she and
her sister are not truly free.
“We haven’t come this far, 16 years and 32 days, to give up,” Gladys said.
C.Agnello SE 0354
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 358 of 569 PageID #:
552
ADVERTISEMENT
E*TRADE PREMIUM
SAVINGS
For a limited time, earn a
3.35
cash bonus up to $2,000.
% Terms apply.*
APY
Member FDIC GET STARTED
INVESTING ACCOUNT
Investing involves risk
New Customer Offer: get up
to $1,500 with a qualifying GET STARTED
deposit. Terms apply.
BROKERAGE ACCOUNT
Trade on your time and your
terms. Get a free stock for LEARN MORE
signing up. Terms apply.
MOST READ
HIGH YIELD SAVINGS
1 Ex-leader Harper says Canada should make ‘any sacrifice necessary’ toGrow
preserve independence from US
your savings faster
with Bread's competitive
4.00 % APY. Easy to open online.
2 SBA says legal permanent residents will be ineligible for itsAPY
loan program, effective March 1
Member FDIC | Terms Apply OPEN ACCOUNT
3 Every Homeland Security officer in Minneapolis is now being issued a body-worn camera, Noem says
360 CHECKING
4 Judge seems skeptical of legal justification for Pentagon’s punishment of Sen. Mark
Member FDICKelly
Earn a $250 bonus with 360
OPEN ACCOUNT
5 What to know about the disappearance of Nancy Guthrie,
Checking. No fees, mother
no of ‘Today’
minimums. Terms apply.
show’s Savannah Guthrie
Sponsors of Advertiser Disclosure
C.Agnello SE 0355
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 359 of 569 PageID #:
553
SUGGESTED FOR YOU
This Month's Top Offers
360 PERFORMANCE
SAVINGS
• No fees
3.30
• No minimums
% • Open in about 5 min
APY
As of 01/08/2026 | Member FDIC OPEN ACCOUNT
360 CHECKING
Member FDIC
Earn a $250 bonus with 360
Checking. No fees, no OPEN ACCOUNT
minimums. Terms apply.
Leverage a powerful platform designed for
self-directed traders.
Advertisement: TradeStation
Level Up with a Georgetown Master's in
Supply Chain Management
Advertisement: Georgetown University
C.Agnello SE 0356
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 360 of 569 PageID #:
554
Earnings Season: What to Watch
Advertisement: Charles Schwab
ADVERTISEMENT
C.Agnello SE 0357
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 361 of 569 PageID #:
555
EXHIBIT Q
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0358
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 362 of 569 PageID #:
556
FILED 6:00 a.m. EST
12.16.2025
FEATURE
Women Are Sent to This Federal Prison for
Dialysis. They Say It’s Killing Them.
Patients at Carswell medical prison in Texas describe unsanitary conditions,
missed treatments and substandard care.
HOKYOUNG KIM FOR THE MARSHALL PROJECT
By KALEY JOHNSON
Evangelina Perez lost count of the number of times her mother, Martha Perez, called her from
federal prison, gasping for breath because she had missed dialysis treatments for her kidney
failure.
At 59, Martha Perez also had diabetes and congestive heart failure. She had been in various federal
prisons since 2005 on money laundering and drug convictions. In 2018, the Bureau of Prisons sent
her to the Federal Medical Center Carswell in Fort Worth, the country’s only federal medical prison
for women.
C.Agnello SE 0359
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 363 of 569 PageID #:
557
The bureau houses some of the sickest women at Carswell, and it’s the only federal women’s prison
with in-patient dialysis — a critical, life-sustaining treatment for people with kidney failure.
But in court documents she filed pleading for release, Perez described her worsening health and
her fear of dying at Carswell. In May 2022, another incarcerated person had to help her write a final
request because of her poor vision. Just over a year later, Perez died in a Fort Worth hospital. No
family was with her.
“I understand the circumstances, but initially, like there is a care that they should have been
providing,” Evangelina Perez said. “It got to the point where she started retaining fluid on her chest,
and she ended up passing away from a heart attack.”
This article was published Perez had serious illnesses that required consistent care. But
in partnership with the Carswell does not adequately provide the dialysis care that the
Fort Worth Star-Telegram.
Bureau of Prisons claims it does, according to lawyers, medical
experts, former bureau officials, along with court and medical
records. Women at Carswell describe missed treatments, poor education for patients, dialysis
machines that break down mid-treatment or that lacked enough clean water, and other routine
problems.
A photo of Martha Perez is found in a bin of family photos at the Perez’s home in
Prescott Valley, Arizona, on March 9, 2025. COURTNEY PEDROZA FOR THE MARSHALL PROJECT
Doctors who reviewed the women’s court filings and allegations say the problems described would
put dialysis patients in serious danger. Legal filings by prisoners, medical records and expert court
testimony raise flags about preventable — and potentially fatal — conditions arising from
C.Agnello SE 0360
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 364 of 569 PageID #:
558
substandard care. The Bureau of Prisons, which is supposed to fix those problems, operates with
little to no external oversight over its medical care.
A federal judge overseeing a dialysis patient’s compassionate release case said testimony from
seven women on dialysis was “concerning,” but said he could not approve the release. Doing so, the
judge said, could imply the entire Bureau of Prisons provides ineffective dialysis care.
Michele Deitch, director of the Prison and Jail Innovation Lab at the University of Texas in Austin,
said people in prison “have a constitutional right to receive medical care for their serious medical
needs. And dialysis is certainly an example of that.”
If the federal government “cannot take care of people and meet their needs as required by the
Constitution,” Deitch said, “then we have no business locking them up.”
The Bureau of Prisons declined requests for an interview. In answers to emailed questions,
spokespersons wrote that the agency provides adequate dialysis care, including sufficient staffing
and education for patients.
“At present, there have been no reports or claims concerning the quality of the dialysis care being
provided at FMC Carswell,” wrote spokesman Donald Murphy.
Carswell has been the subject of numerous investigations calling into question its treatment of
incarcerated people. In 2020 and 2021, women at the facility described negligent medical care and
malicious treatment as COVID spread through the prison. In 2023, a Fort Worth Star-Telegram
investigation highlighted a pattern of sexual abuse by staff. In response, a state representative
called for a congressional inquiry into the prison, though none were launched.
W
hen she died in June 2023, Perez was one of about 15 women at Carswell receiving
dialysis. The treatment uses a surgically-installed port to connect a patient to a machine
that filters their blood, removing toxins the kidneys no longer can process, before
pumping the cleaned blood back into the patient. The process takes 3 to 5 hours and is
usually needed three times a week — or patients may risk serious complications and death.
Kidney failure can be caused by a multitude of issues, most commonly diabetes, high blood
pressure and chronic kidney disease. Perez had all three. In June 2021, Perez started dialysis after
C.Agnello SE 0361
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 365 of 569 PageID #:
559
she had a stroke.
Federal medical prisons, despite their name, are not hospital-like facilities: They keep incarcerated
people with medical needs, but in many cases, do not provide all of their care in-house. Carswell,
which houses approximately 1,200 people, contracts with the University of North Texas Health
Science Center for much of its medical care. The Health Science Center, in turn, subcontracts
dialysis services to the private provider U.S. Renal Care of West Fort Worth, according to the Bureau
of Prisons. Under Carswell’s contract with the Health Science Center, the bureau is still responsible
for providing all dialysis equipment.
U.S. Renal Care confirmed it provides dialysis at Caswell, but did not respond to several interview
requests and other emailed questions about its services there.
Dialysis is only part of the treatment for people with kidney failure. They also need a strict diet and
water intake monitoring, and blood work to closely check various chemical levels. A patient’s port
must be kept extremely clean to avoid sepsis, a life-threatening infection.
According to Bureau of Prisons mortality reviews from 2015 to April 2020, at least three women
undergoing dialysis at Carswell died in that time period. All three women had been transferred to
Carswell specifically to receive medical treatment, and all three developed sepsis prior to their
death, according to the mortality reviews. Reason Magazine obtained the documents through a
records request and provided them to The Marshall Project.
Sepsis is far less common if staff follow the proper contamination protocols for dialysis machines,
said Dr. Charles Howard, who for 13 years was a medical officer at the FMC Devens in
Massachusetts, which includes a large dialysis unit. Howard occasionally worked as acting medical
director at the prison.
There are no publicly available records of deaths in federal prisons. The Bureau of Prisons has yet to
fulfill records requests for mortality reviews or the number of dialysis patients who have died at
Carswell.
When asked how many Carswell dialysis patients have died since 2020, a bureau spokesman
initially said “zero.” When asked specifically about Perez, who died in 2023, spokesman Scott Taylor
said that no one “had passed away as a result of their condition that required dialysis.” Regarding
Perez’s death, Taylor said “there was no correlation between the need for dialysis and the cause of
death.”
C.Agnello SE 0362
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 366 of 569 PageID #:
560
F
ive current or former dialysis patients at Carswell spoke with The Marshall Project and
also detailed in court records the dialysis conditions there. Four others described dialysis
treatments in compassionate release pleas or other court records. The women said their
treatment included severe cramping during dialysis, treatment sessions cut short or
missed, and poor machine maintenance, such as broken parts, discolored tubing, and machine
settings that were set incorrectly. Four women said pipes in the water room would break
frequently, and the machines would sit in puddles of water.
“The truth lies in the consistency of the women’s statements,” said Amber Rabon, a lawyer in one of
the women’s cases, who has been a federal criminal defense attorney since 2008.
Evangelina Perez, Martha Perez’s daughter, said her mother told her she frequently missed dialysis
treatments prior to her death in 2023.
“I can’t even keep track of how many times that occurred where they wouldn’t complete the
dialysis on them. And that was an issue, and she would call me, she would call me panicking
because she knows how she would get if she skipped one,” Evangelina Perez said. “She would be so
short of breath that her stomach would be tight from all the fluid she was retaining.”
C.Agnello SE 0363
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 367 of 569 PageID #:
561
Evangelina Perez holds a photo of her mother, Martha Perez, down the street from her
home in Prescott Valley, Arizona, on March 9, 2025. COURTNEY PEDROZA FOR THE MARSHALL PROJECT
Members of the Perez family pose for a portrait near their home in Prescott Valley,
Arizona, on March 9, 2025. From left are Francisco Perez, Francisco Perez IV, Daniel
Perez, Gabriella Perez, Evangelina Perez, Cecilia Perez, and Angelica Perez. COURTNEY
PEDROZA FOR THE MARSHALL PROJECT
She said her mother would tell staff that something was wrong, but they “said ‘She was fine, she’s
fine,’ until there was fluid literally coming out of her belly button,” Perez said.
Missing a dialysis session is dangerous for patients, said Dr. Rebecca Ahdoot, a kidney specialist at
the University of California Irvine. Without rigorous dialysis, toxins can build up, and the person
can die.
Alicia Elliott, who was on dialysis at Carswell for 15 months while incarcerated on drug charges,
said in court records and interviews that she was forced to miss appointments or had her treatment
cut short multiple times. In late 2022 and twice in early 2023, Elliot emailed Carswell’s associate
C.Agnello SE 0364
Case 2:24-cr-00366-NJC Document 24-1
Filed 03/11/26 Page 368 of 569 PageID #:
562
warden for medical to complain about being taken off dialysis early. In one case, she said staff
wanted to leave early because of ice on the roads.
Sanjuana Garcia-Ramirez started dialysis at Carswell in November 2023. She said she had been on
dialysis for two years before incarceration; comparatively, she said treatments at Carswell are less
consistent and the machines are poorly managed.
“I have four kids I have to get back home to, and it frightens me that I might not make it out of here
because of the way they run dialysis,” said Garcia-Ramirez, who is serving a 6-year sentence on a
drug conviction.
Successful dialysis goes hand-in-hand with proper nutrition plans, said Howard.
“A patient has to be their own advocate, and they have to be very, very, very much aware of what
they need and what they have to do to manage their condition,” Howard said. If they're not able to
do it or they’re not properly educated, he said, “they will not do well on dialysis.”
But Stephanie Williams, who said she was on dialysis at Carswell for 11 months, said women would
start dialysis and get no education on nutrition. Some women did not know that people with
kidney problems have to monitor their potassium, sodium, fluid and phosphorus levels, for
example, or they risk possibly fatal complications.
“Them girls, when I said phosphorus, they said, ‘What is phosphorus?’ And [I was] like, ‘What are
you doing?’” Williams said.
She also said in interviews and court records that women were not told how to keep their port
clean — or the importance of doing so. Women would shower without covering up their ports and
get them wet, which increases the risk for infection, she said.
“It’s a lack of education. It’s not the girls’ fault. But it's killing them.”
W
hile U.S. Renal Care oversees dialysis treatments and a nephrologist — a kidney specialist
— visits once a month, patients rely on Carswell staff at all other times for medical needs.
Doctors, lawyers and the Bureau of Prisons’ own budget proposal this year questioned
whether Carswell has the ability and resources to provide that care.
C.Agnello SE 0365
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 369 of 569 PageID #:
563
Understaffing and a depleted budget have sapped federal prisons of resources over the last few
years. In a 2024 report, the Office of the Inspector General identified providing adequate medical
care as one of the primary challenges the bureau faces.
In the bureau’s 2025 budget submission to Congress, the agency lamented its difficulties in hiring
and maintaining medical staff. The budget cited a 2016 Office of Inspector General report, which
declared recruitment of medical professionals to be “one of the Bureau’s greatest challenges.”
Carswell is no exception. In 2022, Carswell then-staff union leader Jennifer Howard filed a
whistleblower complaint about COVID-19 guidance and staff shortages at the facility. At the time,
Howard told the Fort Worth Star-Telegram that staffing levels were “unacceptable for a medical
facility.”
The entrance to the Federal Medical Center Carswell in Fort Worth, Texas. YFAT YOSSIFOR/KERA
Despite understaffing, the bureau may face further cuts. In February, the agency announced it
would reduce or eliminate retention pay for correctional officers, a decision that American
Federation of Government Employees said would “exacerbate staffing shortages and make working
conditions less safe.”
A former bureau warden and administrator, Jason Terris, questioned Carswell’s ability to care for
dialysis patients as part of his declaration cited in a compassionate release case for Feliza Renteria,
a 45-year-old dialysis patient at the facility.
Renteria arrived at Carswell in 2021. But the dialysis treatments have made her sicker, she argued
in court records. In an interview, she described excruciating pain during treatment. “I did not
C.Agnello SE 0366
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 370 of 569 PageID #:
564
experience what a cramp was before I was incarcerated —- I did dialysis a year before this and
never had cramps,” she said.
Dialysis patients should not have constant cramping, Ahdoot said. Cramps can be a sign that too
much fluid is being pulled out of the body too quickly, she said, and treatment should be adjusted.
Patients “certainly shouldn’t be on dialysis and suffering,” said Ahdoot, who has been a
nephrologist for 12 years. “If you are having crazy cramps all the time, then there is certainly a
problem.”
Carswell’s contract with the Health Science Center says a kidney doctor will be available to patients
once a month for up to four hours. Ideally, Ahdoot said, a nephrologist should see patients once a
week to ensure the right amount of fluid is being pulled off during dialysis.
In his declaration for Renteria’s suit, Terris wrote that he did not know if the staff at Carswell could
handle the “logistical and care-related challenges” Renteria’s condition presented due to staffing
shortages and a lack of resources.
But those statements are part of the reason U.S. District Judge Anthony Battaglia, in California’s
Southern District, denied Renteria’s compassionate release. When he denied the request in a
September 2023 hearing, Battaglia said granting her motion could have implications beyond
Renteria’s case because of the message it would send about the bureau’s care.
“I mean, granting relief here, does that mean that every dialysis patient in the Bureau of Prisons
should be similarly accommodated because the quality of care is, perhaps, ineffective?” Battaglia
said, according to a court transcript. “I'm looking at sort of the greater picture here. Because some
of the accounts, from some of the people, is concerning.”
Last year, the Ninth Court of Appeals denied Renteria’s appeal for compassionate release.
T
here is no third-party agency currently monitoring dialysis treatments at Carswell.
Multiple outside agencies that used to evaluate the Bureau of Prisons’ medical care no
longer do so.
C.Agnello SE 0367
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 371 of 569 PageID #:
565
Carswell’s contract with the Joint Commission, which provided the facility's accreditation as a
healthcare organization, expired in October 2020 and was not renewed, according to the Bureau of
Prisons spokesperson. The American Correctional Association ended its audits of the agency in
2023, after the Office of Inspector General found the Bureau of Prisons was “in effect, paying ACA
to affirm [the bureau’s] own findings,” and as a result, there was “no real certification or action for
improvement.”
The state of Texas does not monitor Carswell either. Oversight rules are built into Carswell’s
contract with the Health Science Center, but neither the Sciences Center nor Carswell have
responded to requests for monitoring records.
According to its contract with the bureau, the Health Science Center is supposed to send quarterly
reports about dialysis treatment at Carswell to a bureau administrator. But Health Science Center
spokeswoman Paula Cobler said the hospital does not have those records; she said U.S. Renal Care
is responsible for them and provides Carswell with copies. Another Health Science Center
spokesman, Andy North, said the dialysis reports include “patient-care specific problems
experienced during the quarter,” but declined to answer questions about what those problems
entailed.
U.S. Renal Care did not provide those records to The Marshall Project. The bureau has not fulfilled a
records request for those quarterly reports.
The Office of the Inspector General found evidence that the bureau’s contracts are not always
monitored adequately. A 2023 audit found the bureau’s contract evaluations were often untimely,
incomplete, or for the wrong time period. This may result in the agency not getting the best
services, the report noted.
In 2024, then-President Joe Biden signed the Federal Prison Oversight Act to increase independent
inspections of prisons, but Congress has not approved money for the inspections. Deitch, of the
Prison and Jail Innovation Lab, said the priority now is for the act to be fully funded “to provide the
critical oversight role that is needed."
C.Agnello SE 0368
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 372 of 569 PageID #:
A
566
s her fears of dying inside prison grew, Perez filed requests for a reduced sentence or
compassionate release five times between 2012 and 2022. A judge had not ruled on her
final release request when she died in July 2023.
Compassionate release is a way to address deficiencies in care for some incarcerated people, but it
is seldom granted. Judges look for evidence that a prison can’t provide the necessary treatment,
said Marc Stern, the court-appointed monitor for the State of Arizona Department of Corrections.
Without that proof, most motions will be denied. Out of the nine dialysis patients at Carswell that
The Marshall Project identified, eight filed for sentence reduction or compassionate release since
2022. Seven were denied. In the remaining case, a judge initially denied the request, but reversed
the decision and released the woman in 2020, citing “the abominable COVID-19 statistics at FMC
Carswell.” The judge said the facility’s inaccurate data suggested the bureau could not be trusted to
care for someone with complicated health conditions.
A photo of Martha Perez is found in a bin of family photos at the Perez’s home in
Prescott Valley, Arizona, on March 9, 2025. COURTNEY PEDROZA FOR THE MARSHALL PROJECT
In a compassionate release request for one woman, who asked not to be named due to fear of
retaliation, her lawyer wrote that Carswell frequently missed her dialysis treatments, forcing her to
go five to six days without. The woman’s former physician wrote a letter in November 2023 in
support of her release request, saying that “continued incarceration would be severely detrimental”
to her health due to her complex medical issues.
Williams, the former Carswell patient, described Perez’s deteriorating condition as “the scariest
thing I’ve seen.”
C.Agnello SE 0369
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 373 of 569 PageID #:
567
“She was bad off,” said Williams, who was released in November 2023. “The week she died, she
said, ‘I need to see a doctor right now.’”
In the days before Perez’s death, her family said, the bureau did not tell them that her condition
had worsened or that she was in the hospital. She was admitted to John Peter Smith Hospital in
Fort Worth on July 2, 2023, for low blood pressure after a dialysis treatment, medical records show.
Her admission records at the hospital indicated she had had a serious heart attack and, on July 6,
she was transferred to Medical City Fort Worth Hospital for surgery.
Medical staff tried to reverse the damage and stabilize Perez, but on July 7, she lost her pulse. For
one hour, staff tried to bring Perez back. A prison guard finally called the family to ask if they
wanted them to continue to try to resuscitate Perez. Her daughter said the decision fell to her father
as Perez’s next of kin. He told them to stop.
In a letter to the family, the Bureau of Prisons said Perez died from cardiac arrest; she also had
coronary artery disease. Seven months later, Evangelina Perez got her mother’s death certificate
from the state of Texas. The cause of death is listed as “pending investigation.”
Kaley Johnson is a reporter based in Texas. She can be reached at kaleyalyssajohnson@gmail.com.
Correction: An earlier version of this story incorrectly identified Dr. Charles Howard's former roles in
the Bureau of Prisons. He was a medical officer at FMC Devens in Massachusetts, occasionally
serving as acting medical director. He later was medical director at the Federal Detention Center
Miami.
C.Agnello SE 0370
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 374 of 569 PageID #:
568
EXHIBIT R
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0371
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 375 of 569 PageID #:
(/) 569 Podcasts Schedule Donate Listen
(https://ra
interactiv
(https://ncpr.secureallegiance.com/ncpr/WebModule/Dona
P=WEBSITE&PAGETYPE=PLG&CHECK=Bhp4yZNb2aeYC2D
Barbour Was Moving On Sisters' Case
Before Controversial Comments
(https://www.northcountrypublicradio
was-moving-on-sisters-case-before-
controversial-comments)
BY MARK MEMMOTT (HTTPS://WWW.NPR.ORG/PEOPLE/104192887/MARK-MEMMOTT) — DEC 30, 2010 11:50AM
(NPR)
The news from Mississippi that Republican Gov. Haley Barbour has suspended
the life sentences (http://www.npr.org/templates/story/story.php?
storyId=132451849) of two sisters convicted in 1994 for their roles in an armed
robbery that netted $11 has naturally led to questions from reporters about
whether the decision would have been made if Barbour hadn't gotten himself into
controversy (http://www.npr.org/blogs/itsallpolitics/2010/12/21/132232306/haley-
barbour-explains-he-wasnt-praising-racist-group) two weeks ago with comments
that at first blush seemed to praise a 1960s-era supremacist group.
The sisters, Jamie and Gladys Scott, are African-American and their cause has
been taken up by civil rights activists in recent years.
C.Agnello SE 0372
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 376 of 569 PageID #:
For its part, the NAACP is praising Barbour's
570 decision
(http://www.naacp.org/news/entry/breaking-news-scott-sisters-coming-home-at-
last/). And on CNN moments ago, NAACP President and CEO Ben Jealous was
asked whether he thinks Barbour's decision was accelerated by the comments
controversy.
"We don't know" for sure, he said. "There certainly has been a lot of conjecture"
about a connection.
But, "the reality is that we've been going back and forth with [Barbour's] office"
about the sisters' case "for a very long time. ... And we were anticipating this
[decision] weeks ago."
Barbour, Jealous said, "has show interest for a long time" in freeing the Scott
sisters.
Jamie Scott, 38, needs regular dialysis. Gladys, 35, has offered to give her sister a
kidney -- and their release is conditioned on her going through tests to determine
whether that's possible, and surgery to do it if it is.
© 2026 NPR (http://www.npr.org/sections/thetwo-way/2010/12/30/132477213/barbour-was-moving-on-sisters-
case-before-controversial-comments)
NCPR is supported by:
More from NPR
Researchers say no evidence of
TikTok censorship, but they remain AI chatbots upended their lives.
wary (/news/npr/nx-s1- Then they turned to each other
5701409/researchers-say-no- (/news/npr/nx-s1-5699470/ai-
(https://www.lakeplacidclub.com/)
evidence-of-tiktok-censorship-but- chatbots-upended-their-lives-then-
they-remain-wary) C.Agnellothey-turned-to-each-other)
SE 0373
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 377 of 569 PageID #:
571
Newly released court records reveal
misconduct inquiry into federal
judge (/news/npr/nx-s1- Will the U.S. withdraw military
5699462/newly-released-court- forces from Syria? (/news/npr/nx-
records-reveal-misconduct-inquiry- s1-5701418/will-the-u-s-withdraw-
into-federal-judge) military-forces-from-syria)
(https://www.beardsley.com/)
Moltbook is the newest social The Supreme Court lets California
media platform — but it's just for use its new, Democratic-friendly
AI bots (/news/npr/nx-s1- congressional map (/news/npr/nx-
5697392/moltbook-is-the-newest- s1-5691890/the-supreme-court-lets-
social-media-platform-but-it-s-just- california-use-its-new-democratic-
for-ai-bots) friendly-congressional-map)
Search for Nancy Guthrie, mother
of 'Today' show host Savannah
Guthrie, enters 4th day
Reporter's notebook: A peek inside (/news/npr/nx-s1-5699399/search-
the Olympic Village (/news/npr/nx- for-nancy-guthrie-mother-of-today-
s1-5699473/reporter-s-notebook-a- show-host-savannah-guthrie-
peek-inside-the-olympic-village) enters-4th-day)
C.Agnello SE 0374
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 378 of 569 PageID #:
572
Greetings from Kyiv, where candles
are the last option during wartime
blackouts (/news/npr/g-s1- Bezos orders deep job cuts at
108433/greetings-from-kyiv-where- 'Washington Post' (/news/npr/nx-
candles-are-the-last-option-during- s1-5699328/bezos-orders-deep-job-
wartime-blackouts) cuts-at-washington-post)
Congress faces tight deadline to
Photos: Scenes from the 150th fund DHS. And, Ryan Routh faces
Westminster Dog Show sentencing (/news/npr/g-s1-
(/news/npr/nx-s1-5698120/photos- 108639/congress-faces-tight-
scenes-from-the-150th- deadline-to-fund-dhs-and-ryan-
westminster-dog-show) routh-faces-sentencing)
Contact NCPR
(/contact.html) Radio
(/programs/grid.html)
North Country Public Radio Schedule
(http://www.stlawu.edu) St. Lawrence (/programs/grid.html)
University (http://www.stlawu.edu) FM Frequencies
Canton, New York 13617 (/about/coverage.html)
1-877-388-6277 • radio@ncpr.org NCPR Shows
(mailto:radio@ncpr.org) (/programs/localpro.html)
NCPR is a proud affiliate of: News/Talk
National Public Radio (/programs/newspro.html)
(http://www.npr.org) Music/Arts
American Public Media (/programs/artspro.html)
(http://americanpublicmedia.publicradio.org) Podcasts
Public Radio International (/programs/podcasts.html)
(http://www.pri.org)
C.Agnello SE 0375
CasePublic Radio Exchange Document 24-1
2:24-cr-00366-NJC Filed 03/11/26 Page 379 of 569 PageID #:
(http://www.prx.org)
© 2026 North Country Public Radio
573
About
(/about.html)
Award-winning NCPR
(/about/awards.html)
Our Staff
(/about/staff.html)
News Team
(/news/reporters)
Contact NCPR
(/contact.html)
Comments
(/contact/comment.html)
Submissions
(/contact/submissions.html)
Subscriptions
(/contact/newsletter.html)
Jobs at NCPR (/hiring.html)
Station Governance
(/about/stationgovernance.html)
Executive Council
(/about/ec.html)
FCC Public Inspection Files
(/about/stationgovernance.html#PIFs)
FCC Applications
(/about/stationgovernance.html#FCCApps)
Support NCPR
(/support)
Donate
(https://donate.nprstations.org/ncpr/donate)
Donate via PayPal
(https://www.paypal.com/cgi-
bin/webscr?cmd=_s-
xclick&hosted_button_id=6FT565C8NJTAN)
MemberCard
(http://www.membercard.com/ncpr/)
Sponsorship
(http://ncpr.org/underwriting)
Planned Giving
(http://northcountrypublicradio.plannedgiving.org/)
Endowment
(/support/endowment.html)
C.Agnello SE 0376
NCPR
Case Funders
2:24-cr-00366-NJC Document 24-1 Filed 03/11/26
574
Page 380 of 569 PageID #:
(/support/whopays.html)
Vehicle Donation
(https://www.cardonationwizard.com/north-
country-public-
radio/info/car-donation-
canton-ny.html)
C.Agnello SE 0377
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 381 of 569 PageID #:
575
EXHIBIT S
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0378
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 382 of 569 PageID #:
576
What to Expect After Donation
Last updated: December 16, 2024
Medically reviewed by: NKF Patient Education Team
Life doesn’t change much after donating. After recovering from surgery, donors are able to
return to work, physical activity and are able to eat a regular diet.
About Life After Donating a Kidney
For most living donors, life after donating a kidney isn’t too different than before you donated.
You can return to work a couple of weeks after you recover from surgery, return to physical
activity, and eat a normal, well-balanced diet. Your risks of long-term problems like kidney
failure are very low.
Recovering From Surgery
Usually, living donors stay in the hospital 1 to 2 nights after surgery. How long you’ll stay in the
hospital depends on if you’re in pain, when your doctors feel that you’re ready to go home, and
how close you live. Most donors who live close by can return home after 1-2 nights. If you live
far away, the team will ask you to stay in the area for about one week, just in case you need to
go back to the hospital for any reason.
The two most common types of surgery (laparoscopic and robotic) are non-invasive, meaning
they allow the surgeon to remove your kidney safely while making the least number of incisions
to allow your body to recover more quickly.
Right after surgery and a few weeks into recovery, you may feel:
Bloated and constipated, which are normal symptoms after any surgery.
Itching and some pain around the incisions (cuts) as they heal.
C.Agnello SE 0379
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 383 of 569 PageID #:
Fatigue (feeling tired). 577
Some discomfort from the gas that you’ll receive during surgery that allows the surgeons to
see inside your body to remove the kidney.
Shoulder pain after donating as any gas that is left over moves up the body.
Most living donors make a full recovery four to six weeks after surgery.
Becoming a Living Donor
Free, self-paced online videos about
donating a kidney.
Eating and Drinking After Donating
There are no limits on what you can eat and drink after you donate. You should follow a
healthy, well-balanced diet to take good care of your body and your one kidney.
You can drink alcohol after donating in moderation. Drinking too much alcohol is dangerous,
and there is a greater risk for dehydration with one kidney. Make sure you drink enough water
throughout the day to take care of your kidney and to stay hydrated.
Getting Pregnant after Donating
Pregnancy after donation is possible. It is usually recommended to wait at least six months to
one year after donating. Your body will need time to adjust to living with one kidney.
C.Agnello SE 0380
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 384 of 569 PageID #:
Generally, living kidney donors do well with 578
pregnancy after they donate. However, you may be
at a slightly higher risk for gestational diabetes (diabetes during pregnancy), gestational
hypertension (high blood pressure during pregnancy), and preeclampsia (health condition
causing swelling, headaches and protein in your urine). If you’re a female donor, you should talk
to your OBGYN doctor and transplant team before trying to get pregnant.
Length of Life After Donating Your Kidney
Donating your kidney doesn’t change your life expectancy (how long you’ll live). In fact, some
studies have shown that living donors live longer than the average person. This is because
donors are in very good health and get a full medical evaluation before being approved to
donate.
Keeping Up with Your Health
It’s important to see your primary care provider (the doctor you see for yearly check-ups) each
year to have your urine (pee), blood pressure, and kidney function (GFR) checked. While living
donors are healthier than the average person and only have a slightly higher risk of developing
kidney disease than someone who does not donate, it’s still important to go to your annual
doctor visits to keep an eye on your overall health.
You won’t have to take any special medicines because you donated your kidney. You'll only
need pain medicine and stool softeners for a few weeks after surgery.
Returning to Work, Sports, and Physical Activity
You should be able to return to normal activities four to six weeks after surgery. If you have a
physical job, and need to return to work before six weeks, you can ask your employer if you can
do paperwork or other work that involves little to no physical activity. You shouldn't lift anything
heavier than a jug of milk for about six weeks after surgery.
You also may not be able to drive for up to two weeks, which is why your transplant team will
talk to you about having a care partner (caregiver) or someone to rely on for a week or two after
surgery.
C.Agnello SE 0381
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 385 of 569 PageID #:
It’s a good idea to avoid contact sports where 579
your kidney could get hurt. Wearing protective
gear such as padded vests under clothing can help protect your kidney during sports. Talk with
your transplant team before returning to exercise or playing any type of sports.
Emotional Health After Donating
During your donation journey, you may experience a mix of both positive and negative
emotions, including the excitement of waiting to see if you’re approved to donate. Then, once
you donate and the emotional buildup ends, you may experience uncomfortable emotions,
including feeling "down" and not like yourself for a short period of time. This is something that
happens to a lot of living donors, but it’s important to remember that these feelings only last
while you’re recovering and during the first few weeks after surgery. Living donors are also
typically very healthy, active people so having the down time during recovery can sometimes
add to these unpleasant feelings.
As long as you're aware of the possibility of feeling down, you can take some steps to help you
feel better if you do experience them, including:
Talking with another living donor before or after you donate. You can ask your transplant team
to connect you with someone at their center, or contact NKF Peers, a mentoring program
where you can talk to a living donor (by phone or video) about their experience and ask
questions.
Talk with a close friend or family member about how you're feeling for emotional support. Try
scheduling a time every day or week so that you have something to look forward to while you
recover.
If you have and enjoy certain hobbies that involve little to no physical activity, try to continue
them.
Taking walks or other light physical activity can help you feel better (when your transplant
team says it’s okay).
Most people who have donated a kidney report having a positive experience overall, with 90-
95% of donors saying that they would make the decision to donate again, if they could.
Long-Term Risks of Living Donation
While donating a kidney is generally very safe, it’s important to know about the possible long-
C.Agnello SE 0382
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 386 of 569 PageID #:
term health issues that you could be at risk for580
later in life, including high blood pressure.
Needing a Kidney Transplant After Donation
Your transplant team will talk to you about anything related to your health that may put you at a
higher risk of developing kidney disease and be very thoughtful before approving you to
donate. In rare cases, people who donate a kidney may have kidney failure and need a
transplant later in life.
Less than 1% of people who donate develop End Stage Kidney Disease and need a kidney
transplant. If you end up needing a kidney transplant after donating, you will be given a higher
priority on the deceased donor waitlist.
If you donate through a National Kidney Registry (NKR) program, you’ll be given priority for a
living donor kidney. As of 2024, NKR has had 6,000 people donate through their programs, and
none of these donors have needed a kidney transplant.
Questions for your Health Care team
How soon will I be able to go home after surgery based on where I live?
Are there any sports that I should avoid after I donate? Can we talk about the activities I care
about and how donating might affect them?
Can you connect me with someone who has donated at your center?
More resources
Talk to someone who has donated (NKF Peers)
Ask questions and get help finding a transplant center (NKF CARES)
This content is provided for informational use only and is not intended as medical advice or as a substitute for the
medical advice of a healthcare professional.
C.Agnello SE 0383
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 387 of 569 PageID #:
© 2026 National Kidney Foundation, Inc. 581
C.Agnello SE 0384
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 388 of 569 PageID #:
582
EXHIBIT T
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0385
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 389 of 569 PageID #:
583
How the Economic Loss Guideline Lost its Way, and
How to Save It
Barry Boss* and Kara Kapp**
TABLE OF CONTENTS
I. INTRODUCTION .................................................................................................. 605
A. History of the Guidelines ............................................................................. 607
1. Overview and Purpose of the Sentencing Guidelines .............................. 607
2. History and Evolution of the Economic Loss Guideline ......................... 608
II. SECTION 2B1.1 TODAY .................................................................................... 614
A. The Loss Guideline Has Lost its Way .......................................................... 614
B. A Judicial Consensus Has Emerged that the Section 2B1.1 Loss Guideline is
Unduly Harsh ................................................................................................... 618
III. EMPIRICAL DATA SHOWS THAT SECTION 2B1.1 IS NOT FOLLOWED IN THE
MAJORITY OF CASES, AND HAS NOT PREVENTED WIDESPREAD SENTENCING
DISPARITIES .......................................................................................................... 620
IV. REFORM OF SECTION 2B1.1’S LOSS TABLE IS URGENTLY NEEDED ............... 628
I. INTRODUCTION
This Article revisits a stubborn problem that has been explored by
commentators repeatedly over the past thirty years, but which remains unresolved
to this day. The economic crimes Guideline, Section 2B1.1 of the United States
Sentencing Manual, routinely recommends arbitrary, disproportionate, and often
* Co-Chair of Commercial Litigation Department and White Collar Defense & Investigations
Practice at Cozen O’Connor. Former Co-Chair of the U.S. Sentencing Commission’s Practitioner’s
Advisory Group and former Co-Chair of the American Bar Association’s Criminal Justice Section
Sentencing Committee. J.D., George Washington University Law School, 1985; B.A., Bates College,
1982.
** Partner at Cozen O’Connor in the White Collar Defense & Investigations Practice, J.D.,
Stanford Law School, 2010; B.A. Dartmouth College, 2006. Deepest thanks to Dean Erwin
Chemerinsky and Judge Bruce Black for their wisdom and patient mentorship over the years and their
invaluable comments on this article. Special thanks also to Sara Frank for her excellent edits and
support. We also wish to express our profound gratitude to the staff of the Ohio State Journal of
Criminal Law for their thoughtful and excellent edits.
605
C.Agnello SE 0386
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 390 of 569 PageID #:
584
606 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
draconian sentences to first-time offenders of economic crimes.1 These
disproportionate sentences are driven primarily by Section 2B1.1’s current loss
table, which has an outsized role in determining the length of an economic crime
offender’s sentence. Moreover, this deep flaw in the Guideline’s design has led
many judges to lose confidence entirely in the Guideline’s recommended sentences,
leading to a wide disparity of sentences issued to similarly situated economic crime
offenders across the country.2 Accordingly, this Guideline has failed to address the
primary problem it was designed to solve—unwarranted disparities among similarly
situated offenders. Worse still, it not only has failed to prevent such unwarranted
disparities, its underlying design actively exacerbates them.
In the wake of the United States Sentencing Commission’s recent launch of its
Interactive Data Analyzer in June 2020, the authors have identified new evidence
that this pernicious problem continues to persist.3 In Part I, we review the history
and purposes of the Sentencing Guidelines, generally, and the economic crimes
Guideline specifically. In Part II, we explain how the current version of the economic
crimes Guideline operates in practice, the extraordinarily high sentences it
recommends in high-loss cases, and the resulting overemphasis on loss that
overstates offenders’ culpability. In Part III, we analyze data made available through
the Commission’s Interactive Data Analyzer and discuss our findings. In Part IV,
we offer a series of reforms designed to restore the judiciary’s and practitioners’
respect for this Guideline so that it may serve its animating purpose—to reduce
unwarranted sentencing disparities among similarly situated offenders.
1 Section 2B1.1 provides the sentencing framework for the following crimes, all of which are
referred to hereinafter as “economic crimes”: fraud and deceit, forgery, larceny, embezzlement, theft,
offenses involving stolen property, property damage or destruction, and counterfeiting crimes. U.S.
SENT’G GUIDELINES MANUAL § 2B1.1 (U.S. SENT’G COMM’N 2018). The Section 2B1.1 loss table is
also specifically incorporated into Section 2C.1.1, which covers bribery offenses, certain extortion
offenses, and honest services fraud. U.S. SENT’G GUIDELINES MANUAL § 2C1.1(b)(2) (U.S. SENT’G
COMM’N 2015). Accordingly, these additional offenses are likewise grouped in for purposes of the
analysis that follows with the Section 2B1.1 offenses as “economic crimes.”
2 Letter from Jonathan Wroblewski, Dir., Dep’t of Just. Off. of Pol’y and Legis., to Hon.
William K. Sessions III, Chair of the Sent’g Comm’n 2, 4–5 (June 28, 2010).
3 While this is not the first article to address this question based on a review of empirical data
of sentences issued to fraud offenders, the most recent scholarship addressing this issue analyzed data
that is now almost a decade old, from 2002–2012. See, e.g., Jillian Hewitt, Note, 50 Shades of Gray:
Sentencing Trends in Major White-Collar Cases, 125 YALE L.J. 1018, 1038 (2016) (reviewing data
from S.D.N.Y. cases between 2002–2012); see also U.S. SENT’G COMM’N, U.S. SENT’G AND GUIDELINE
APPLICATION INFO. FOR § 2B1.1 OFFENDERS (2013), (reviewing national data between 2003–2012)
https://www.ussc.gov/sites/default/files/pdf/research-and-publications/research-projects-and-
surveys/economic-crimes/20130918-19-symposium/Sentencing_Guideline_Application_Info.pdf.
C.Agnello SE 0387
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 391 of 569 PageID #:
585
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 607
A. History of the Guidelines
1. Overview and Purpose of the Sentencing Guidelines
Before 1984, federal judges sentencing economic crime offenders had
unfettered discretion to impose any sentence up to the statutory maximum and were
not required to consider any specific factors or explain their reasoning for the
sentence imposed.4 In 1984, Congress passed the Sentencing Reform Act (SRA) and
created the United States Sentencing Commission (the Commission), in an effort to
reduce unwarranted sentencing disparities.5 In doing so, Congress instructed the
Commission to promulgate Sentencing Guidelines and to use the average sentences
issued to offenders for each type of crime as an anchor in creating these uniform
guidelines.6 The Commission grounded most of the Sentencing Guidelines (the
Guidelines) in empirical data, anchoring the promulgated ranges in historic judicial
practice for similarly situated offenders.7 Under the SRA, as passed in 1984, the
imposed Guidelines were binding on federal judges, unless a recognized basis for a
departure under the Guidelines applied.8
In 2005, in United States v. Booker, the Supreme Court struck down the
provisions of the SRA that made the Guidelines mandatory.9 It reasoned that a
mandatory Guidelines system effectively resulted in mandatory increased sentences
on the basis of judicial fact-finding in violation of the Sixth Amendment.10 To avoid
this constitutional infirmity, the Court rendered the Guidelines advisory.11
At bottom, Congress commissioned the Guidelines to make federal criminal
sentences fairer by addressing a central problem—wildly disparate sentences issued
4 See Mistretta v. United States, 488 U.S. 361, 363–64 (1989).
5 Sentencing Reform Act of 1984, Pub. L. No. 98–473, 98 Stat. 1987; Kenneth R. Feinberg,
Federal Criminal Sentencing Reform: Congress and the United States Sentencing Commission, 28
WAKE FOREST L. REV. 291, 295–96 (1993).
6 28 U.S.C. § 994(m).
7 U.S. SENT’G GUIDELINES MANUAL ch. 1, pt. A, at 4 (U.S. SENT’G COMM’N 2009) (“In its
initial set of guidelines, the Commission sought to solve both the practical and philosophical problems
of developing a coherent sentencing system by taking an empirical approach that used as a starting
point data estimating pre-guidelines sentencing practice. It analyzed data drawn from 10,000
presentence investigations, the differing elements of various crimes as distinguished in substantive
criminal statutes, the United States Parole Commission’s guidelines and statistics, and data from other
relevant sources in order to determine which distinctions were important in pre-guidelines practice.
After consideration, the Commission accepted, modified, or rationalized these distinctions.”). Note,
however, that the Commission deviated from this approach with respect to crafting the economic
crimes Guideline. See infra Part I.B.
8 United States v. Booker, 543 U.S. 220, 233–34 (2005) (citing 18 U.S.C. § 3553(b)(1), which
provided that federal courts “shall impose a sentence of the kind, and within the range” established by
the Sentencing Guidelines).
9 Id. at 227.
10 Id. at 232–34.
11 Id. at 245.
C.Agnello SE 0388
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 392 of 569 PageID #:
586
608 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
to similarly situated offenders. In reaction to this problem, it tasked the Commission
with drafting Guidelines that would present a uniform baseline from which all judges
would start. While Booker restored to federal judges the ability to exercise their
discretion as to whether to apply the Guideline range in a given case, the Court has
emphasized the Guidelines’ continued importance as a uniform “starting point and
the initial benchmark” from which all judges should begin their analysis.12
Thus, the Guidelines, even post-Booker, remain a foundational anchor in which
all federal sentences are grounded. Past scholarship has documented that the
Guidelines’ function as an anchor has been largely effective in practice.13 As Judge
Jed Rakoff explains, the Guidelines “create[] a kind of psychological presumption
from which most judges are hesitant to deviate too far.”14 For an anchoring Guideline
to in fact promote fairness in sentencing, however, it must in fact be fair and
reasonable in its recommendations. While some Guidelines may serve this purpose
faithfully, the economic crimes Guideline manifestly does not.15
2. History and Evolution of the Economic Loss Guideline
The sentencing calculation for federal economic crimes include an
enhancement under the Section 2B1.1 economic loss table in any case where the
government can show an intended or actual loss. The calculations in this loss table
are extraordinarily important because the magnitude of the enhancement can single-
handedly drive the severity of sentences issued to economic crime offenders,
especially in large-loss cases. This outcome, moreover, is by design. The loss table
was, in fact, designed (and redesigned) by the Commission to drive the severity of
sentences for fraud offenders based primarily on the magnitude of the loss. As the
Guidelines explain, “the Commission has determined that, ordinarily, the sentences
of defendants convicted of federal offenses should reflect the nature and magnitude
of the loss caused or intended by their crimes.”16
The initial fraud Guideline was located at Section 2F1.1, while the initial theft
Guideline was located at Section 2B1.1. In drafting these two Guidelines, the
Commission was tasked, as with the Guidelines generally, to collect data on past
sentencing practices for fraud and theft cases and draw on that data in crafting the
relevant guidelines. In preparing the initial loss table in Section 2F1.1, the
Commission did in fact review presentence reports from 10,000 prior cases in
12 Gall v. United States, 552 U.S. 38, 49 (2007).
13 Hewitt, supra note 3, at 1022; Mark W. Bennett, Confronting Cognitive “Anchoring Effect”
and “Blind Spot” Biases in Federal Sentencing: A Modest Solution for Reforming a Fundamental
Flaw, 104 J. CRIM. L. & CRIMINOLOGY 489, 492–93 (2014); Jed S. Rakoff, Why the Federal Sentencing
Guidelines Should Be Scrapped, 26 FED. SENT’G REP. 226, 228 (2013); David M. Isaacs, Note, Baseline
Framing in Sentencing, 121 YALE L.J. 426, 439–41 (2011).
14 Rakoff, supra note 13, at 228.
15 See infra Parts I.B, II, & III.
16 18 U.S.C. app. § 2B1.1 background (2018).
C.Agnello SE 0389
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 393 of 569 PageID #:
587
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 609
1984.17 However, after reviewing the empirical data, the Commission deviated from
its standard practice of anchoring the recommended sentencing ranges in the
empirical data.18 First, the Commission chose to exclude from its analysis fifty
percent of the total data—every sentence in which a judge had issued a sentence of
probation.19 In addition, even after excluding half of the relevant data, it chose to
recommend more severe sentences than the mean sentences of incarceration
reflected in the remaining 50 percent of empirical data it considered.20
The Commission deviated from the empirical data for two reasons. First, the
Commission sought to encourage judges to issue sentences of incarceration for fraud
offenders.21 In addition, the Commission aimed to equalize sentences for “white
collar” fraud and “blue collar” theft offenses, in contrast to past practices, in which
theft offenders had received more severe sentences than fraud offenders.22
The resulting loss table for fraud offenses topped out at $5 million, with
enhancements increasing by one point for every loss bracket. The original table was
as follows:
Loss Amount Applicable
Enhancement
More than $2,000 +1
More than $5,000 +2
More than $10,000 +3
More than $20,000 +4
More than $50,000 +5
More than $100,000 +6
More than $200,000 +7
More than $500,000 +8
More than $1,000,000 +9
More than $2,000,000 +10
More than $5,000,000 +11
17 Mark Osler & Mark W. Bennett, A “Holocaust in Slow Motion?”: America’s Mass
Incarceration and the Role of Discretion, 7 DEPAUL J. FOR SOC. JUST. 117, 140–41 (2014); Mark H.
Allenbaugh, “Drawn from Nowhere”: A Review of the U.S. Sentencing Commission's White-Collar
Sentencing Guidelines and Loss Data, 26 FED. SENT’G REP. 19, (2013).
18 James E. Felman, The Need to Reform the Federal Sentencing Guidelines for High-Loss
Economic Crimes, 23 FED. SENT’G REP. 138, 138 (2010); U.S. SENT’G GUIDELINES MANUAL ch. 1, pt.
A (U.S. SENT’G COMM’N 2009) (recognizing that while the Commission generally anchored its
Guidelines in empirical data, it departed from the empirical data in crafting guidelines for economic
crimes); Stephen Breyer, The Federal Sentencing Guidelines and the Key Compromises Upon Which
They Rest, 17 HOFSTRA L. REV. 1, 7, 23 (1988).
19 Mark W. Bennett et al., Judging Federal White-Collar Fraud Sentencing: An Empirical
Study Revealing the Need for Further Reform, 102 IOWA L. REV. 939, 950 n.48 (2017).
20 Osler & Bennett, supra note 17, at 141.
21 Bennett et al., supra note 19, at 951.
22 Bennett et al., supra note 19, at 950–51.
C.Agnello SE 0390
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 394 of 569 PageID #:
588
610 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
Under this table, a first-time fraud offender involved in a $1 million+ fraud
scheme, with no applicable enhancements other than loss, would have faced an
Offense Level of 15 and a Guideline range of 18–24 months.23 Likewise, a first-time
fraud offender involved in a $20 million+ fraud scheme, with no applicable
enhancements other than loss, would have faced an Offense Level of 17 and a
Guideline range of 24-30 months.24 The Commission’s initial deviations from the
underlying empirical data thus resulted in modest increases in the severity of
sentences, but these initial ranges were far from the arbitrary, disproportionate, and
at times draconian sentences produced under today’s loss table.
Indeed, the Commission’s initial deviations from the empirical data, and the
resulting Guideline ranges, were modest in comparison to the distortions caused by
subsequent amendments. Specifically, since the initial loss Guideline was
promulgated, there have been three significant amendments that dramatically
increased the severity of the loss table.
In 1989, in the wake of the savings and loan fraud crisis, the Commission
increased the severity for offenses greater than $40,000 and extended the loss table
by four brackets from losses greater than $5 million to losses greater than $80
million.25 The resulting loss table was as follows:
Loss Amount Applicable
Enhancement
More than $2,000 +1
More than $5,000 +2
More than $10,000 +3
More than $20,000 +4
More than $40,000 +5
More than $70,000 +6
More than $120,000 +7
More than $200,000 +8
More than $350,000 +9
More than $500,000 +10
More than $800,000 +11
More than $1,500,000 +12
More than $2,500,000 +13
More than $5,000,000 +14
More than $10,000,000 +15
More than $20,000,000 +16
23 See U.S. SENT’G GUIDELINES MANUAL ch. 5, pt. A (U.S. SENT’G COMM’N 1987),
https://www.ussc.gov/sites/default/files/pdf/guidelines-manual/1987/manual-pdf/Chapter_5.pdf.
24 See id.
25 18 U.S.C. app. §§ 99, 154 (1989).
C.Agnello SE 0391
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 395 of 569 PageID #:
589
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 611
More than $40,000,000 +17
More than $80,000,000 +18
Under the revised table, the enhancement for offenses between $500,000 and
$10 million generally increased by 2–3 levels each. However, the enhancements for
high-loss frauds, those greater than $10 million, increased at even steeper
increments—ranging from a 4-level additional enhancement for frauds between $10
and $20 million to a 7-level additional enhancement for frauds over $80 million.
Under this revised table, a first-time fraud offender involved in a $1 million+ fraud
scheme, with no applicable enhancements other than loss, would face an Offense
Level of 17 and a Guideline range of 24–30 months (previously reserved for a $20
million fraud offender).26 Further, a first-time fraud offender involved in a $20
million+ fraud scheme, with no applicable enhancements other than loss, would face
an Offense Level of 22 and a Guideline range of 41–51 months.27 At the highest end,
just two-years after the initial Guidelines took effect, a first-time fraud offender
involved in an $100+ million fraud scheme would face an Offense Level of 24 and
a Guideline range of 51–63 months, more than double the range from the original
loss table.
Subsequent amendments caused the loss table to become further untethered
from any empirical grounding. In 2001, as part of the Commission’s “Economic
Crime Package,” the Commission merged three guidelines, 2F1.1 (fraud), 2B1.1
(theft/embezzlement), and 2B3.1 (property destruction) into one Guideline, Section
2B1.1.28 The new Guideline contained an even harsher loss table, which used two-
level increments instead of the former one-level increase for each loss bracket.29 The
amendment additionally increased the severity even more stiffly for losses greater
than $400,000, ranging from 4–5 levels for losses over $1 million to an increase of
8 levels for losses greater than $100 million.30 The resulting loss table was as
follows:
26
See U.S. SENT’G GUIDELINES MANUAL ch. 5, pt. A (U.S. SENT’G COMM’N 1989),
https://www.ussc.gov/sites/default/files/pdf/guidelines-manual/1989/manual-pdf/Chapter_5.pdf.
27 Id.
28 18 U.S.C. app. § 617 (2001).
29 Id. This series of amendments was influenced in part by a desire by some to equalize
sentences for drug crimes and fraud crimes. See, e.g., Barry Boss & Jude Wikramanayake, Sentencing
in White Collar Cases: Time Does Not Heal All Wounds, 13 FED. SENT’G. REP. 15, 16–17 (2000). As
these commentators observed, however, inflating the loss tables on this basis would “not only
artificially and unnecessarily increas[e] the sentences in these economic crime cases, but also
legitimiz[e] as a sentencing baseline the draconian and irrational sentencing scheme in drug cases.” Id.
at 17.
30 Id.
C.Agnello SE 0392
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 396 of 569 PageID #:
590
612 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
Loss Amount Applicable
Enhancement
More than $5,000 +2
More than $10,000 +4
More than $30,000 +6
More than $70,000 +8
More than $120,000 +10
More than $200,000 +12
More than $400,000 +14
More than $1,000,000 +16
More than $2,500,000 +18
More than $7,000,000 +20
More than $20,000,000 +22
More than $50,000,000 +24
More than $100,000,000 +26
Taking again the example of a first-time fraud offender involved in a $1
million+ fraud scheme, under this new table, with no applicable enhancements other
than loss, the offender would face an Offense Level of 22 (5 levels higher) and a
Guideline range of 41–51 months (previously reserved for a $20 million fraud
offender).31 Further, a first-time fraud offender involved in a $20 million+ fraud
scheme, with no applicable enhancements other than loss, would face an Offense
Level of 28 and a Guideline range of 78–97 months (6.5–8 years), nearly double the
previously applicable range.32 At the highest end, a first-time fraud offender
involved in an $100+ million fraud scheme, with no other enhancements, would face
an Offense Level of 32 and a Guideline range of 121–151 months (10–12.5 years),
more than double the range from the original loss table.33
The final series of significant enhancements came just two years later, in 2003,
after the passage of the Sarbanes-Oxley Act. The Commission again amended
Section 2B1.1, this time by increasing the base offense level from 6 to 7 for fraud
offenses carrying a statutory maximum penalty of 20 years or more.34 Additionally,
the loss table was further extended by two additional brackets, making the highest
loss bracket greater than $400 million.35 At the $400 million+ level, an offender
would receive a 30-level increase.36 For a $400 million+ first-time fraud offender,
31 See U.S. SENT’G GUIDELINES MANUAL ch. 5, pt. A (U.S. SENT’G COMM’N 2001),
https://www.ussc.gov/sites/default/files/pdf/guidelines-manual/2001/manual/CHAP5.pdf.
32 See id.
33 See id.
34 18 U.S.C. app. §§ 647, 653 (2003).
35 Id.
36 Id.
C.Agnello SE 0393
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 397 of 569 PageID #:
591
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 613
this enhancement alone would translate to an Offense Level of 37, with a Guideline
range of 210–262 months (17.5–21.8 years).37
In 2015, the Commission issued amendments to Section 2B1.1 that modestly
addressed concerns previously raised about the operation of the loss table.38 Most
significantly, this amendment adopted a narrower (subjective) interpretation for
intended loss, defining intended loss as “the pecuniary harm that the defendant
purposely sought to inflict.”39 However, this amendment in no way corrected the
underlying problem—that the loss table has become entirely divorced from the
empirical data that informed its creation. Rather, with respect to the loss table itself,
the Commission maintained the same number of brackets and adjusted the ranges
upward for inflation. For example, the “more than $5000” bracket became a “more
than $6,500” bracket, the “more than $10,000” bracket became a “more than
$15,000” bracket, and so on. However, it simultaneously increased the scale of
attendant penalties, thus doubling-down on the draconian punishments that
correspond to high-loss economic offenses.
In combination, this series of amendments resulted in a loss table today that
recommends sentences for economic crimes that are orders of magnitude greater
than the same sentence for the same crime back in the mid-1980s. For example, as
Judge Rakoff explains, while a typical fraud in 1987 would have produced a
guideline range of 30–37 months, by 2003, that same case would result in a
recommended sentence of 151–188 months, an increase of more than 500 percent.40
This gulf between the recommended Guideline sentences and any grounding in
empirical data fundamentally undermines the Guideline’s ability to fulfill its key
function of “reflect[ing] a rough approximation of sentences that might achieve §
3553(a)’s objectives.”41 For this reason, the Supreme Court has held that courts have
broad discretion to vary from the Guidelines, even in a run-of-the-mill case, where
the particular Guideline provision is not anchored in “empirical data and [past]
national experience,” as is the case with Section 2B1.1.42
37 See U.S. SENT’G GUIDELINES MANUAL ch. 5, pt. A (U.S. SENT’G COMM’N 2003),
https://www.ussc.gov/sites/default/files/pdf/guidelines-manual/2003/manual/2003guid.pdf.
38 For a full description and analysis of these amendments, see James E. Felman, Reflections
on the United States Sentencing Commission’s 2015 Amendments to the Economic Crimes Guideline,
27 FED. SENT’G REP. 288 (2015).
39 U.S. SENT’G GUIDELINES MANUAL APP. C § 792 (2015).
40 United States v. Gupta, 904 F. Supp. 2d 349, 351 (S.D.N.Y. 2012), aff'd, 747 F.3d 111 (2d
Cir. 2014).
41 Kimbrough v. United States, 552 U.S. 85, 109 (2007) (quoting Rita v. United States, 551
U.S. 338, 350 (2007)).
42 Id. at 109–110 (quoting United States v. Pruitt, 502 F.3d 1154, 1171 (2007)).
C.Agnello SE 0394
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 398 of 569 PageID #:
592
614 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
II. SECTION 2B1.1 TODAY
A. The Loss Guideline Has Lost its Way
As discussed below, the economic crimes Guideline, Section 2B1.1, has failed
in its mission and, in its current form, cannot be justified by the policy concerns
animating its dysfunctional design. Under today’s Section 2B1.1 loss table, the loss
calculation is often the determining factor in the severity of an economic crime
offender’s sentence. As the size of the loss increases, particularly at the higher end
of the loss table, penalties escalate in magnitude, especially in conjunction with the
sentencing table. Today’s loss table is as follows:
Loss Amount Applicable
Enhancement
More than $6,500 +2
More than $15,000 +4
More than $40,000 +6
More than $95,000 +8
More than $150,000 +10
More than $250,000 +12
More than $550,000 +14
More than $1,500,000 +16
More than $3,500,000 +18
More than $9,500,000 +20
More than $25,000,000 +22
More than $65,000,000 +24
More than $150,000,000 +26
More than $250,000,000 +28
More than $550,000,000 +30
At the highest end, under today’s loss table, a loss of $550 million+ results in
an Offense Level of 37, with a corresponding Guideline range of 210–262 months
(17.5–21.8 years).43 Notably, this is the minimum applicable Guideline range at this
loss level, which would only apply to an offender who was not a leader, supervisor,
or even manager within the scheme.44 Rather, this 17–21 year sentence range would
apply to the participants with the least responsibility for the scheme. In combination
with other potentially applicable enhancements, such as a 4-level leadership
enhancement and a 2-level sophisticated means enhancement, a first-time offender’s
43 See U.S. SENT’G GUIDELINES MANUAL ch. 5, pt. A (U.S. SENT’G COMM’N 2016),
https://www.ussc.gov/sites/default/files/pdf/guidelines-manual/2016/GLMFull.pdf.
44 See U.S. SENT’G GUIDELINES MANUAL § 3B1.1 (U.S. SENT’G COMM’N 2018) (providing for
2-, 3-, or 4-level enhancements for offenders who were leaders, organizers, managers, or supervisors
in a scheme).
C.Agnello SE 0395
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 399 of 569 PageID #:
593
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 615
Offense Level can reach or exceed 43, which corresponds to a sentence of life
imprisonment.45 Thus, as a result of these amendments, the economic crimes
Guideline in high loss cases recommends staggering sentences otherwise reserved
for violent crimes—regularly sentences of life imprisonment—even for defendants
with no prior criminal history.
Such extraordinarily stiff penalties could only be justified by compelling policy
concerns that these draconian penalties directly address and resolve. The purpose of
Section 2B1.1’s focus on the magnitude of the loss is to serve as a proxy for both
the seriousness of the offense and for the offender’s relative culpability. As the
Guideline explains, “[L]oss serves as a measure of [both] the seriousness of the
offense and the defendant’s relative culpability and is a principal factor in
determining the offense level under this guideline.”46 However, the current loss
Guideline performs poorly on both fronts.
To begin with, the calculated loss amount often serves as a poor proxy for either
metric because the manner in which loss is calculated in economic crimes cases is
often necessarily imprecise. Section 2B1.1 defines “loss” as the greater of actual or
intended loss attributable to the entire group of co-defendants. “Actual loss” is
defined as “the reasonably foreseeable pecuniary harm that resulted from the
offense.”47 Many factors make it difficult to accurately calculate this sum. Courts
must, among other things, separate out the loss attributable to an economic crime
from other complicating causal factors, such as independent market events.48 Thus,
loss calculations are not often a particularly precise metric of the actual magnitude
of harm caused. Indeed, courts have recognized that calculating loss is “more an art
than a science”49 and courts are “not required to compute the loss resulting from a
fraud offense ‘with precision.’”50 Accordingly, the inherent impreciseness of many
loss calculations calls into question the fairness of using this metric alone to
overwhelmingly drive the magnitude of sentences imposed on economic crime
offenders.
As to the loss calculation’s “fit” as a proxy for seriousness of the offense, the
current loss enhancement serves as a poor proxy for this factor for two additional
reasons. First, the loss calculation ignores a critical consideration—the extent to
45 See United States v. Adelson, 441 F. Supp. 2d 506, 509 (S.D.N.Y. 2006); see also United
States v. Parris, 573 F. Supp. 2d 744, 754 (E.D.N.Y. 2008) (“[W]e now have an advisory guideline
regime where, as reflected by this case, any officer or director of virtually any public corporation who
has committed securities fraud will be confronted with a guidelines calculation either calling for or
approaching lifetime imprisonment.”).
46 U.S. SENT’G GUIDELINES MANUAL § 2B1.1 background (U.S. SENT’G COMM’N 2018).
47 Id. at § 2B1.1 cmt. 3.
48 Peter J. Henning, White Collar Crime Sentences after Booker: Was the Sentencing of Bernie
Ebbers Too Harsh?, 37 MCGEORGE L. REV. 757, 763 (2006).
49 United States v. Deleon, 704 F.3d 189, 193–94 (1st Cir. 2013) (quoting United States v.
Rostoff, 53 F.3d 398, 407 (1st Cir. 1995)).
50 United States v. Kumar, 617 F.3d 612, 632 (2d Cir. 2010) (quoting United States v. Jacobs,
117 F.3d 82, 95 (2d Cir. 1997)).
C.Agnello SE 0396
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 400 of 569 PageID #:
594
616 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
which individuals suffered any actual loss. For example, if a group of offenders
dreamt up a $600 million scheme, but caused $0 in actual loss, each offender will be
sentenced under Section 2B1.1 as if he caused a $600 million loss to actual victims,
which would correspond to a minimum Guideline range—if no other enhancements
apply—of 210–262 months (17.5–21.8 years). This is so even if the intended loss
was “impossible or unlikely to occur.”51 In contrast, an offender who caused $50
million in actual losses to actual victims would correspond to Offense Level 29 and
a Guideline range of 87–108 months (7.25–9 years)—a sentence over ten years
smaller. The loss table produces this absurd result despite the fact that a crime that
causes $0 in actual loss is, in reality, substantially less harmful to society than a
crime causing $50 million in actual losses to individuals. Yet, the loss table is
entirely blind to this factor in the degree of punishment it recommends.
Second, even where the calculation is based on actual (rather than intended)
loss, that calculation often does not correspond with the degree of losses in fact
suffered by the victims. It seems axiomatic that a crime in which individuals were
deprived of a needed good or service or suffered out-of-pocket losses is more severe
than one causing only a diffuse loss of revenue to the government. Yet, the loss table
is entirely insensitive to these significant distinctions in the relative seriousness of
an offense. In fact, there are many tax, healthcare, and other fraud offenses with high
loss amounts resulting from a diffuse loss of government revenue, but where no
individual was deprived of any good or service or suffered a loss of any kind.52
Third, using the steep ladder of loss enhancements as a proxy for seriousness
of the offense results in unfair double counting. The reliance on loss as a proxy for
seriousness of the offense is rooted in an assumption that larger loss frauds tend to
be more sophisticated, affect a larger number of victims, result in greater illicit gains,
and involve an abuse of one’s position of power. However, other specific
enhancements in Section 2B1.1 already cover many of these same characteristics.
For example, Section 2B1.1 contains specific and separate enhancements for
whether the offense involved (i) sophisticated means,53 (ii) a large number of
51 U.S. SENT’G GUIDELINES MANUAL § 2B1.1 application n. 3(A)(ii) (U.S. SENT’G COMM’N
2018).
52 See, e.g. Farha v. United States, Dkt. 16-888, Petition for Certiorari at 9, 26 (Jan. 2017),
https://www.scotusblog.com/wp-content/uploads/2017/02/16-888-cert-petition.pdf (noting in a health
care fraud case with an $11 million intended loss that the entity involved in the fraud conviction “was
no sham corporation; it was a nationally accredited [organization] that provided services exceeding
[state agency] standards” and that the case “involves no fake patients, unnecessary treatments, or
substandard care”); United States v. Free, 839 F.3d 308, 309, 315 (3d Cir. 2016) (in a bankruptcy fraud
case with a $1.83 million loss, all creditors were paid in full); United States v. Woods, No. 1:18-cr-
00390-DLF, Doc. 24, at 17–18 (D.D.C. Dec. 13, 2019) (observing that defendant in $500,000 honest
services fraud scheme “did not obtain payment for any fake services, but rather provided the contracted
training services for which the D.C. Government paid”); United States v. Bernard, No. 2:17-cr-00061-
SPC-MRM, Doc. 59, at 10–11 (M.D. Fl. Jan. 23, 2018) (noting that in a tax fraud scheme with a $42
million loss, “there is no victim who inevitably has or will suffer a pecuniary loss” and the only harm
was a $4.3 million loss of tax revenue to the government).
53 U.S. SENT’G GUIDELINES MANUAL § 2B1.1(b)(10) (U.S. SENT’G COMM’N 2018).
C.Agnello SE 0397
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 401 of 569 PageID #:
595
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 617
victims,54 (iii) a loss to a Government health care program over $1 million, $7
million, or $20 million,55 (iv) gross receipts of more than $1 million from financial
institutions,56 (v) a violation of securities or commodities law where the defendant
was an officer or director of a publicly traded company, a registered broker or dealer,
or an investment adviser,57 or (vi) certain misappropriations of trade secrets.58
Accordingly, the severe increases in the loss table, coupled with these independent
enhancements, result in deeply unfair double counting, which in high loss cases
often results in the extreme and disproportionate recommendation of life
imprisonment.59
The current loss table is likewise a poor proxy for relative culpability in many
cases. For example, the loss calculation fails to account for the extent to which the
offender personally profited from the offense. Indeed, each offender is responsible
for the total reasonably foreseeable loss attributable to all co-defendants,60 regardless
of how much each offender personally profited from that amount. Accordingly, an
offender who saw no profit at all or a nominal amount of profit will be sentenced
just as harshly under the loss table as the mastermind who received the greatest share
of the profits. This calculation thus fails to fairly account for relative culpability
among offenders and results in disproportionately high sentences for more marginal
co-conspirators.61
Further, the loss tables are entirely insensitive to motive—the reason why an
offender committed the crime.62 As explained in United States v. Ranum, “the
guidelines treat a person who steals $100,000 to finance a lavish lifestyle the same
as someone who steals the same amount to pay for an operation for a sick
child . . . [F]rom the victim’s perspective the loss is the same no matter why it
occurred. But from the standpoint of personal culpability, there is a significant
difference.”63 The loss table’s insensitivity to these considerations makes it a highly
imperfect proxy for both seriousness of the offense and the offender’s relative
54 Id. at § 2B1.1(b)(2).
55 Id. at § 2B1.1(b)(7).
56 Id. at § 2B1.1(b)(17)(A).
57 Id. at § 2B1.1(b)(20).
58 Id. at § 2B1.1(b)(14).
59
See Daniel S. Guarnera, A Fatally Flawed Proxy: The Role of “Intended Loss” in the U.S.
Sentencing Guidelines for Fraud, 81 MO. L. REV. 716, 743–44 (2016).
60 U.S. SENT’G GUIDELINES MANUAL §§ 1B1.3(a)(1), 2B1.1 application n. 3(A)(i) (U.S. SENT’G
COMM’N 2018) (“‘Actual loss’ means the reasonably foreseeable pecuniary harm that resulted from the
offense.”).
61 See United States v. Watt, 707 F. Supp. 2d 149, 155 (D. Mass. 2010) (relying on the Third
Circuit for the proposition that, as to peripheral defendants, the loss table can “overstate both the degree
of [defendant’s] criminality and his need to be corrected” (quoting United States v. Stuart, 22 F.3d 76,
82 (3d Cir. 1994))).
62 See United States v. Dikiara, 50 F. Supp. 3d 1029, 1032 (E.D. Wis. 2014) (noting that “the
[loss] guideline fails to take into account other relevant factors, including motive and culpability”).
63 353 F. Supp. 2d 984, 990 (E.D. Wis. 2005).
C.Agnello SE 0398
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 402 of 569 PageID #:
596
618 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
culpability. In short, the calculation of loss often fails to directly address the
underlying policy concerns justifying reliance on this factor. Accordingly, the
current loss table, which is often the determining factor in an economic crime
offender’s sentence, has an outsized role in influencing such sentences.
B. A Judicial Consensus Has Emerged that the Section 2B1.1 Loss Guideline is
Unduly Harsh
As a result of these problems with the design and operation of the loss table, a
broad judicial consensus has developed that Section 2B1.1’s loss table overstates
culpability in a great many cases.64 For instance, New York federal courts, which
handle some of the highest volumes of fraud cases in the country,65 have repeatedly
criticized the grossly disproportionate nature of the loss tables. They have called the
loss tables “patently absurd”66 and “a black stain on common sense”67 that rely upon
a “flawed methodology for tabulating white-collar sentences[.]”68 Accordingly,
courts have concluded that imposing sentences corresponding to the loss tables
would “effectively guarantee[] that many such sentences would be irrational on their
face.”69 An array of white collar scholars and commentators have likewise echoed
these concerns.70
64 See, e.g., United States v. Moody, 2013 U.S. Dist. LEXIS 109506, at *14 (D. Colo. Aug. 5,
2013) (adopting view that the loss guidelines are “fundamentally flawed”); see also United States v.
Corsey, 723 F.3d 366, 378 (2d Cir. 2013) (Underhill, J., concurring); Bennett et al., supra note 19, at
941–44 (“[A]s the guidelines have become harsher and crimes both more complex and involving larger
loss amounts, judges regularly sentence economic criminals well below the minimum guideline in all
but the smallest of loss cases.”); United States v. Johnson, 2018 U.S. Dist. LEXIS 71257 at *11–12
(E.D.N.Y. Apr. 26, 2018) (reasoning that the “loss-enhancement numbers do not result from any
reasoned determination of how the punishment can best fit the crime, nor any approximation of the
moral seriousness of the crime”); United States v. Gupta, 904 F. Supp. 2d 349, 351 (S.D.N.Y. 2012);
United States v. Parris, 573 F. Supp. 2d 744, 745, 747–48 (E.D.N.Y. 2008) (finding that application of
18-point loss enhancement was “patently absurd” and varying downward 17 points for defendant with
$2.5 million loss (quoting United States v. Adelson, 441 F. Supp. 2d 506, 515 (S.D.N.Y. 2006))).
65 See U.S. D. Cts., Criminal Defendants Pending, by Offense—During the 12-Month Periods
Ending September 30, 2017 and 2018, JUDICIAL BUSINESS tbl. D-8 (2018),
https://www.uscourts.gov/sites/default/files/data_tables/jb_d8_0930.2018.pdf.
66 Adelson, 441 F. Supp. 2d at 515.
67 Parris, 573 F. Supp. 2d at 754.
68 Johnson, 2018 U.S. Dist. LEXIS 71257, at *14.
69 Gupta, 904 F. Supp. 2d at 351.
70 See, e.g., Hewitt, supra note 3, at 1022; David Debold & Matthew Benjamin, Essay, “Losing
Ground”—In Search of a Remedy for the Overemphasis on Loss and Other Culpability Factors in the
Sentencing Guidelines for Fraud and Theft, 160 U. PA. L. REV. ONLINE 141, 154–55 (2011); Alan Ellis
et al., At a “Loss” for Justice: Federal Sentencing for Economic Offenses, 25 CRIM. JUST. 34, 35 (2011);
Felman, supra note 18, at 139; Derick R. Vollrath, Note, Losing the Loss Calculation: Toward a More
Just Sentencing Regime in White-Collar Criminal Cases, 59 DuKE L.J. 1001, 1001 (2010); Frank O.
Bowman III, Sentencing High-Loss Corporate Insider Frauds After Booker, 20 FED. SENT’G REP. 167,
C.Agnello SE 0399
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 403 of 569 PageID #:
597
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 619
Especially as the loss amount increases into the millions, the sentences
recommended by the loss table are widely viewed as unduly severe, increasingly
arbitrary, and manifestly disproportionate to the non-violent nature of the underlying
economic crimes.71 For example, a first-time fraud offender convicted of wire fraud
with a calculated loss over $3.5 million, with no other applicable enhancements,
would face an Offense Level of 25 and a Guideline range of 57–71 months. Yet,
under the Guidelines, such an offense level would advise a prison term comparable
to that recommended for arson, aggravated assault or robbery involving serious
bodily injury, and transmission of biological weapons causing serious bodily
injury.72 Likewise, a first-time fraud offender convicted of an offense with a loss
exceeding $9.5 million would face an Offense Level of 27—with no other
enhancements—and a Guideline range of 70–87 months. Again, under the
Guidelines, this sentence is comparable to that recommended for several serious,
violent offenses, including attempted murder, arson, and assault with intent to
commit murder.73 These severe sentences, moreover, are recommended equally to
offenders who caused $9.5 million in losses to actual individuals and to offenders
who caused little or no actual economic harm to any persons.
Further, the magnitude of the scaled loss enhancements far exceeds that of other
enhancements designed to capture similar concerns for culpability and seriousness
of the offense. By way of comparison, another enhancement designed to measure
relative culpability—the leader-organizer enhancement—has only 4 levels of
enhancement, ranging from 2 levels for a manager of a small group to 4 levels for
the most culpable senior leader of a larger group. In contrast, the loss table has 16
brackets, ranging from 2 levels to 30 levels of possible enhancement.
169 (2008); Ellen S. Podgor, Throwing Away the Key, 116 YALE L.J. POCKET PART 279, 280 (2007)
(describing how reliance on “mathematical computation of loss” can result in “exorbitant sentences”
for white-collar defendants); Andrew Weissmann & Joshua A. Block, White-Collar Defendants and
White-Collar Crimes, 116 YALE L.J. POCKET PART 286, 286 (2007); Boss, supra note 29, at 15.
71 See supra, notes 63–68.
72 U.S. SENT’G GUIDELINES MANUAL § 2A2.2 (U.S. SENT’G COMM’N 2018) (aggravated assault
involving a firearm and serious bodily injury to a victim, OL 24 (14 + 5 +5)); Id. § 2B3.1 (robbery
involving firearm, OL 25 (20 + 5)); Id. § 2B3.2 (extortion by force with the threat of death and
brandishing of a firearm, OL 25 (18 + 2 + 5)); Id. § 2K1.4 (arson knowingly creating a serious risk of
death or bodily injury, OL 24); Id. § 2M3.3 (unauthorized disclosure of classified national defense
information to a foreign government, OL 24); Id. § 2M6.1 (transmitting biological weapons causing
serious bodily injury to a victim, OL 24 (20 + 2 + 2)); Id. § 2N1.1 (tampering with consumer products
involving risk of death or bodily injury, OL 25).
73 Id. § 2A2.1 (attempted murder); Id. § 2A2.1 (assault with intent to commit murder); Id. §
2B3.2 (extortion by force with the threat of death and use of a firearm); Id. § 2D1.10 (endangering
human life while illegally manufacturing methamphetamine); Id. § 2K1.4 (arson creating a serious risk
of death or bodily injury).
C.Agnello SE 0400
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 404 of 569 PageID #:
598
620 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
III. EMPIRICAL DATA SHOWS THAT SECTION 2B1.1 IS NOT FOLLOWED IN THE
MAJORITY OF CASES, AND HAS NOT PREVENTED WIDESPREAD SENTENCING
DISPARITIES
As discussed above in Part II.B, the economic loss Guideline has lost respect
among jurists because of its unjustified harshness. Based on its arbitrariness and the
disproportionately severe sentences it often recommends, courts routinely conclude
that these Guidelines do not serve as a reliable proxy for culpability and issue
sentences below the Guideline range.74
This trend has been confirmed by data recently released by the Commission
through its Interactive Data Analyzer. The Interactive Data Analyzer shows that
judges are more likely to vary below the Guideline range in Section 2B1.1 cases
than the average federal criminal case. Specifically, as shown in the last row of
Figure 1, federal judges on average tend to grant non-government sponsored
downward variances to first-time (Category I) offenders in 18 to 20 percent of all
federal criminal cases. In contrast, as shown in the last row of Figure 2, in sentencing
first-time offenders under Section 2B1.1, federal judges, on average, grant non-
74 See, e.g., United States v. Musgrave, 647 Fed. App’x 529, 530, 538 (6th Cir. 2016) (affirming
downward variance for defendant with offense level of 25 and a $1.7 million loss to a sentence of one
day of imprisonment, reasoning that “because the loss Guidelines were not developed using an
empirical approach based on data about past sentencing practices, it is particularly appropriate for
variances.”); Johnson, 2018 U.S. Dist. LEXIS 71257, at *16–20 (finding that application of the 16-
point loss enhancement corresponding to $3.1 million gain would result in a sentence “well out of
proportion to [an] appropriate sentence” and imposing a sentence of 24 months on defendant with total
offense level of 29); Judgment at 2, 8 & Sentencing Transcript at 59, United States v. Murray, No.
1:16-cr-00176-RDM (D.D.C. Feb. 2017), ECF No. 25, 27 (varying downward because loss overstated
culpability and sentencing defendant with loss between $250,000 and $550,000 to 6 months
imprisonment); Minutes & Transcript at 91–92, United States v. Farha, No. 8:11-cr-00115-JSM-MAP
(M.D. Fl. May 19, 2014), ECF No. 882, 885, 888, 891, 903 at 91–2 (varying downward by up to 16.5
years as to defendants convicted at trial of an $11 million fraud from Guideline ranges of 97–293
months (at offense levels 30, 37, and 38), issuing sentences between 12–36 months); United States v.
Suarez-Reyes, No. 8:12-cr-67, 2012 U.S. Dist. LEXIS 178771, at *1, *18, *21 (D. Neb. Dec. 18, 2012)
(finding that the application of a 14-point loss enhancement would “exaggerate [defendant’s]
culpability and would not be an accurate measure of his blameworthiness,” varying downward to
sentence of one day imprisonment for defendant with $693,000 loss); Gupta, 904 F. Supp. 2d at 353,
355 (issuing 24-month sentence to defendant in case involving $5 million gain and offense level of 28);
United States v. Lenagh, No. 8:07-cr-346, 2009 U.S. Dist. LEXIS 9226, at *17–18 (D. Neb. Feb. 6,
2009) (issuing 24-month sentence in a case involving $1.4 million fraud and affording the fraud
Guidelines “less deference” because they are not empirically grounded and as such are “not always a
reliable proxy for the culpability of an individual defendant”); Judgment at 3,5, United States v. Kohll,
No. 8:04-cr-00409-TDT (D. Neb. Nov. 16, 2004), ECF No. 22 (one year of probation for a mail fraud
scheme involving loss of $500,000); United States v. Redemann, 295 F. Supp. 2d 887, 898, 901 (E.D.
Wis. 2003) (issuing sentence of 12 months to defendant in $2.5 million fraud involving false and
inflated invoices, concluding that the amount of loss “under the guidelines substantially exceeded any
fair measure of [defendant’s] culpability”); see also Bennett et al., supra note 19, at 943–44 (“[A]s the
guidelines have become harsher and crimes both more complex and involving larger loss amounts,
judges regularly sentence economic criminals well below the minimum guideline in all but the smallest
of loss cases.”).
C.Agnello SE 0401
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 405 of 569 PageID #:
599
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 621
government sponsored downward variances about 10 percent more frequently, in
about 28 to 30 percent of cases.75
Indeed, courts depart or vary below the Guidelines in the majority of cases to
which the Section 2B1.1 loss enhancement applies. For example, from 2015 through
2019, more than 50 percent of sentences issued to fraud offenders were below the
75 Interactive Data Analyzer, U.S. SENT’G COMM’N, https://ida.ussc.gov fig. 1 & 2. For
purposes of this comparison, we focused on first-time offenders (identified as Category I) because the
loss Guidelines are particularly disproportionately harsh with respect to this specific group.
C.Agnello SE 0402
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 406 of 569 PageID #:
600
622 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
Guideline range.76 The downward variances given to such offenders, moreover, are
typically significant. The mean sentences imposed on fraud offenders in 2018 and
2019 were 21 and 20 months respectively, more than 50 percent below the low end
of the Guideline range.77 Likewise, the median sentences imposed on fraud offenders
in 2015 through 2019 were 12, 15, and 16 months, a 45 to 50 percent below the low
end of the Guideline range.78 This is so despite the significant anchoring effect of
the Guidelines, and despite the fact that scholarship suggests that anchors influence
the judgment of decision makers even when an anchor is incomplete, inaccurate, or
otherwise unreliable.79
The degree of downward variances issued to fraud offenders, moreover, are
typically more substantial than the downward variances issued generally under the
Guidelines. The median sentences from 2015 through 2019 across all crimes were
between 35 and 37 percent below the low end of the Guideline range, as compared
to the 45 through 50 percent downward variances given under Section 2B1.1.80 This
significant trend of substantial downward variances under Section 2B1.1,
accordingly, underscores the substantial degree to which this particular Guideline
has lost judicial confidence. This data thus provides further evidence that the Section
2B1.1 Guideline overstates the judicial assessment of culpability and the seriousness
of these offenses.
While the national data shows that courts vary below the Guideline range under
2B1.1 with higher frequency than in general, and, in so doing, grant substantial
variances downward, there are significant variations across jurisdictions in the
degree to which courts grant downward variances under this Guideline. A review of
all first-time offenders sentenced for economic crimes, by circuit, reveals a
76 U.S. SENT’G COMM’N, 2015 SOURCEBOOK OF FEDERAL SENTENCING STATISTICS tbl.27A
(2015) [hereinafter 2015 SOURCEBOOK]; U.S. SENT’G COMM’N, 2016 SOURCEBOOK OF FEDERAL
SENTENCING STATISTICS tbl.27A [hereinafter 2016 SOURCEBOOK]; U.S. SENT’G COMM’N, 2017
SOURCEBOOK OF FEDERAL SENTENCING STATISTICS tbl.27A [hereinafter 2017 SOURCEBOOK]; U.S.
SENTENCING COMM’N, 2018 SOURCEBOOK OF FEDERAL SENTENCING STATISTICS tbl.31 [hereinafter 2018
SOURCEBOOK]; U.S. SENT’G COMM’N, 2019 SOURCEBOOK OF FEDERAL SENTENCING STATISTICS tbl.31
[hereinafter 2019 SOURCEBOOK]. Notably, the 2015–2019 USSC Sourcebooks provided no statistics
on the number of below-Guideline sentences issued to fraud offenders based on the applicable loss
calculation.
77 2018 SOURCEBOOK, supra note 76, at tbl.40; 2019 SOURCEBOOK, supra note 76, at tbl.40.
78 2015 SOURCEBOOK, supra note 76, at tbl.31C (50% decrease); 2016 SOURCEBOOK, supra note
76, at tbl.31C (50% decrease); 2017 SOURCEBOOK, supra note 76, at tbl.31C (47.8% decrease); 2018
SOURCEBOOK, supra note 76, at tbl.40 (46.7% decrease); 2019 SOURCEBOOK, supra note 76, at tbl.40
(48.9% decrease).
79 See Felman, supra note 18, at 138. Further note that these findings are consistent with
scholarship analyzing earlier data sets. See, e.g., Hewitt, supra note 3, at 1038 (analyzing data from
sentencings in the Southern District of New York between 2002–2012); U.S. SENT’G COMM’N 2013,
supra note 3 (analyzing national data between 2003–2012).
80 2015 SOURCEBOOK, supra note 76, at tbl.31C (36.8% decrease); 2016 SOURCEBOOK, supra
note 76, at tbl.31C (36.4% decrease); 2017 SOURCEBOOK, supra note 76, at tbl.31C (34.9% decrease);
2018 SOURCEBOOK, supra note 76, at tbl.40 (34.8% decrease); 2019 SOURCEBOOK, supra note 76, at
tbl.40 (34.8% decrease).
C.Agnello SE 0403
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 407 of 569 PageID #:
601
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 623
difference of more than 20 percent among the circuits in the degree to which courts
have granted downward variances under Section 2B1.1 over the past 5 years (Figure
3).81
Figure 3
Average Percentage of Non-Government Sponsored
Downward Variances Under § 2B1.1 By Circuit (2015-2019)
45 42.6
41
40
35 30.5 30.5 30.5 29.2
30 26 27 27
25 22.9 22.5
20.5
20
15
10
5
0
1st 2d 3d 4th 5th 6th 7th 8th 9th 10th 11th DC
Circuit Circuit Circuit Circuit Circuit Circuit Circuit Circuit Circuit Circuit Circuit Circuit
Average Percentage of Non-Government Sponsored Downward Variances Under Section 2B1.1 from 2015-2019
The disparities among courts in sentencing first-time economic crime offenders
under Section 2B1.1 are even more substantial when the data is reviewed at a more
granular level, by state.
81 U.S. SENT’G COMM’N, supra note 75, fig. 3. We filtered the Interactive Data Analyzer’s data
down to Category I offenders of economic crimes sentenced under Section 2B1.1 and reviewed the
data, by circuit, from 2015–2019, generated under the “Sentence Imposed Relative to Guideline Range”
table within the Guideline Application tab. We then averaged, for each circuit, the percentages of non-
government sponsored downward variances across the five-year span. We chose to focus on non-
government sponsored below-Guideline sentences for purposes of this comparison to exclude cases in
which judges granted downward variances or departures based on cooperation with the government.
Because cooperation provides a strong reason for a court to grant a below-Guideline sentence
independent of the judges’ assessment of whether the Guideline range is inappropriately high relative
to the offender’s culpability, these cases were excluded from consideration.
C.Agnello SE 0404
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 408 of 569 PageID #:
602
624 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
Figure 4
Average Percentage of Non-Government Sponsored
Downward Variances Under § 2B1.1 By State (2015-2019)
0 10 20 30 40 50 60
Alabama 24.4
Alaska 22.4
Arizona 15.5
Arkansas 26
California 23.9
Colorado 21
Connecticut 40.9
DC 29
Delaware 46.4
Florida 35
Georgia 16
Hawaii 23
Idaho 20.6
Illinois 43.2
Indiana 40
Iowa 20.7
Kansas 13.6
Kentucky 29.7
Louisiana 33.5
Maine 36
Maryland 24.3
Massachusetts 30.5
Michigan 38.7
Minnesota 42.8
Mississippi 24.3
Missouri 36.6
Montana 54.5
Nebraska 39.3
Nevada 20.3
New Hampshire 18
New Jersey 26.2
New Mexico 27.9
New York 41.2
North Carolina 23
North Dakota 13.3
Ohio 26
Oklahoma 33.7
Oregon 32.7
Pennsylvania 28.3
Rhode Island 52
South Carolina 25.7
South Dakota 20.9
Tennessee 24
Texas 15.9
Utah 21.5
Vermont 50.3
Virginia 34
Washington 24.5
West Virginia 32.4
Wisconsin 42
Wyoming 26.5
Average Percentage of Non-Government Sponsored Downward Variances Under Section 2B1.1 from…
C.Agnello SE 0405
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 409 of 569 PageID #:
603
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 625
Figure 5
Average Percentage of Sentences At or Above Guideline
Range Under § 2B1.1 By State (2015-2019)
0 10 20 30 40 50 60 70 80
Alabama 52.8
Alaska 55.5
Arizona 39.2
Arkansas 67.4
California 34.2
Colorado 58.7
Connecticut 25.4
DC 39.7
Delaware 12.9
Florida 47.5
Georgia 40.9
Hawaii 73.5
Idaho 67.3
Illinois 28.8
Indiana 38.9
Iowa 64.6
Kansas 54.8
Kentucky 51.4
Louisiana 51.7
Maine 47
Maryland 31.4
Massachusetts 26.6
Michigan 31
Minnesota 37.4
Mississippi 68.6
Missouri 44.6
Montana 42.9
Nebraska 42.4
Nevada 41
New Hampshire 60.6
New Jersey 33
New Mexico 50.7
New York 28.5
North Carolina 48
North Dakota 52.2
Ohio 41
Oklahoma 61.6
Oregon 23.6
Pennsylvania 40.5
Rhode Island 25
South Carolina 48.3
South Dakota 64
Tennessee 37.6
Texas 61.9
Utah 36.9
Vermont 20.5
Virginia 48.5
Washington 42.3
West Virginia 59.2
Wisconsin 35.3
Wyoming 38.3
Average Percentage of Sentences At or Above Guideline Range Under Section 2B1.1 from 2015-2019
C.Agnello SE 0406
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 410 of 569 PageID #:
604
626 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
Figure 6
Sentences Relative to the Guideline Range Under § 2B1.1
By State (2015-2019)
0 10 20 30 40 50 60 70 80
Alabama 24.4 52.8
22.4 55.5
Arizona 15.5 39.2
26 67.4
California 23.9 34.2
21 58.7
Connecticut 40.9
25.4 29
39.7
Delaware 12.9 46.4
35
16 47.5
Georgia 40.9
23
20.6 73.5
Idaho 67.3
43.2
28.8 40
Indiana 38.9
20.7
64.6
Kansas 13.6 54.8
29.7
51.4
Louisiana 33.5 51.7
36 47
Maryland 2…
31.4
26.6 30.5
Michigan 38.7
31 42.8
24.3 37.4
Mississippi 68.6
36.6 44.6
Montana 42.9 54.5
39.3 42.4
Nevada 20.3 41
18 60.6
New Jersey 26.2
33
27.9 50.7
New York 41.2
23 28.5 48
North Dakota 13.3 52.2
26 41
33.7
Oklahoma 61.6
23.6 28.3 32.7
Pennsylvania 40.5
25 25.7 52
South Carolina 48.3
20.9 64
Tennessee 24 37.6
15.9
21.5 61.9
Utah 36.9
20.5 50.3
34
Virginia 48.5
24.5 42.3
West Virginia 32.4 59.2
35.3 42
Wyoming 26.5
38.3
Average Percentage of Non-Government Sponsored Downward Variances Under Section 2B1.1 from 2015-2019
Average Percentage of Sentences At or Above Guideline Range Under Section 2B1.1 from 2015-2019
C.Agnello SE 0407
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 411 of 569 PageID #:
605
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 627
A review of all first-time economic crime offenders, by state, reveals a
difference of more than 40 percent among various states in the degree to which they
have granted non-government sponsored downward variances under Section 2B1.1
over the past 5 years (Figure 4).82 As Figure 4 demonstrates, in some states, such as
North Dakota and Kansas, courts rarely grant downward variances under Section
2B1.1. In contrast, in other states, such as Montana, Rhode Island, and Vermont,
downward variances are granted in more than half of all cases under Section 2B1.1.
This data thus illustrates that the willingness of courts to grant non-government
sponsored downward variances under Section 2B1.1 can vary dramatically by state
and region. Figure 5 further shows that the extent to which federal courts hew to
Section 2B1.1’s recommended sentences continues to vary dramatically despite the
fact that Section 2B1.1, as with the Guidelines generally, was designed to minimize
unwarranted disparities among similarly situated offenders.83 Courts in some states,
like Arkansas, Hawaii, Mississippi, and South Carolina issue Guideline (or higher)
sentences in more than 60 percent of all cases under Section 2B1.1. In contrast,
courts in other states, like Delaware or Vermont, issue Guideline (or higher)
sentences under Section 2B1.1 in only 10 to 20 percent of cases. There is a gulf of
greater than 50 percent dividing the courts at either end of this spectrum. Further, as
Figure 6 shows, the courts less likely to issue non-government sponsored downward
variances are, as a corollary, more likely to issue Guideline-length sentences.
As this data underscores, deep disparities remain in the extent to which
economic crime offenders are sentenced to Guideline-length sentences under
Section 2B1.1. Moreover, the gap in the relative lengths of sentences issued to 2B1.1
offenders is also likely deep, given that courts granting downward variances under
Section 2B1.1 tend to vary substantially, close to 50 percent below the Guideline
range.84 In fact, these disparities are a direct byproduct of the loss table’s design. As
discussed in Part I.B, Section 2B1.1 was designed to drive the severity of sentences
for economic crime offenders based primarily on the magnitude of the loss.85 Yet, it
is precisely these excessive penalties attendant to high-loss offenses that have driven
many courts to vary deeply below the Guideline range.86 Accordingly, it is the very
design of the loss table itself that perpetuates this deep chasm in sentencing practice
82 We filtered the Interactive Data Analyzer data down to Category I offenders sentenced under
Section 2B1.1 and reviewed the data, by state, from 2015–2019, generated under the “Sentence
Imposed Relative to Guideline Range” table within the Guideline Application tab. For each state, we
then averaged the percentages of non-government sponsored downward variances across the five-year
span.
83 In preparing Figure 5, we filtered the Interactive Data Analyzer data down to Category I
offenders sentenced under Section 2B1.1 and reviewed the data, by state, from 2015–2019, generated
under the “Sentence Imposed Relative to Guideline Range” table within the Guideline Application tab.
For each state, we then averaged the percentages of Guideline sentences and upward departures and
variances across the five-year span.
84 See U.S. SENT’G COMM’N, supra notes 76–77;
85 See supra Part I.B; 18 U.S.C. app. § 2B1.1, supra note 16.
86 See supra Part II.B; supra note 73.
C.Agnello SE 0408
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 412 of 569 PageID #:
606
628 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
under Section 2B1.1. The gulf between the economic crimes Guideline and the
average sentences issued under this Guideline results in particularly unfair
punishment for offenders sentenced by “Guidelines” judges who do not, absent
government cooperation or extraordinary circumstances, vary or depart downward,
and who do not vary downward based on the harshness of the loss tables. As a result,
similarly situated offenders sentenced in different jurisdictions can receive wildly
divergent sentences, despite the fact that this is precisely the problem the Guidelines
were meant to address and correct.
IV. REFORM OF SECTION 2B1.1’S LOSS TABLE IS URGENTLY NEEDED
As detailed above, Section 2B1.1’s loss enhancement is entirely untethered
from its empirical roots,87 fails to effectively address the policy concerns animating
this deviation from prior judicial practice,88 and has lost the confidence of a great
many jurists.89 As a result, the loss enhancement exacerbates, rather than corrects,
the underlying problem of unwarranted sentencing disparities that the Guidelines
were designed to solve.90 Moreover, the loss enhancement results, at times, in
draconian sentences for non-violent offenders that strain our correction facilities and
do nothing to rehabilitate offenders. This cannot and should not be. The time for
reform is now.
Meaningful reform has many facets, but we focus on just two that would make
the greatest impact in restoring proportionality to Section 2B1.1. First, to increase
the reliability of the loss calculation as a proxy for the seriousness of the offense, the
loss calculation should be based on actual loss, not intended loss. The seriousness
of a non-violent offense should generally be measured by the harm actually caused
to society, not by the harm an offender fantasizes about causing. Basing the loss
calculation on actual loss removes the risk of offenders being sentenced to draconian
terms of imprisonment based on an intended loss that was impossible or unlikely to
occur.91 To account for the relatively higher culpability of an offender who intended
a substantially greater loss than that which occurred, the Commission could add a
separate intended-loss enhancement ranging from 2–4 levels, similar to the
aggravating-role enhancement. A separate enhancement would serve as a more
proportional proxy for relative culpability than the current Guideline—which is
entirely indifferent to whether a given economic offense caused any harm at all as
long as a loss was intended.
Alternatively, should the Commission keep intended loss as a basis for the loss
calculation, it should require the Government to prove that the defendant not only
87 See supra Part I.B.
88 See supra Part II.A.
89 See supra Part II.B.
90 See supra Part III.
91 See 18 U.S.C. app. § 2B1.1 application note 3(A)(ii) (defining “intended loss” to include
“intended pecuniary harm that would have been impossible or unlikely to occur”).
C.Agnello SE 0409
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 413 of 569 PageID #:
607
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 629
“purposely sought to inflict” the loss at issue,92 but also that the total intended loss
was substantially likely to occur. Such an amendment would, importantly, ensure a
closer relationship between the evidence of intended loss and the seriousness of the
offense conduct.
In addition, the loss table should be anchored in empirical data. As the Supreme
Court recognized in Kimbrough, Guidelines that reflect empirical data of prior
judicial practice serve a critical institutional role to the courts—offering insight into
national sentencing practice to help courts avoid unwarranted sentencing
disparities.93 The only Guideline loss table that comes close to reflecting prior
judicial practice is the 1987 table, even though that table increased the proposed
sentences beyond what the empirical data demonstrated. In an effort to return this
Guideline to a firm foundation in empirical data untainted by the anchoring influence
of the disproportionate loss Guideline, the Commission should restore the original
loss table from 1987, with adjustments for inflation. It could reasonably add
additional brackets for higher levels of loss than were accounted for in 1987, but
should follow the enhancement pattern established in the 1987 loss table, which
relied on 1-level enhancements for each additional bracket. As adjusted for
inflation,94 our proposed loss table could look as follows:
Loss Amount Applicable
Enhancement
More than $5,000 +1
More than $10,000 +2
More than $20,000 +3
More than $50,000 +4
More than $100,000 +5
More than $225,000 +6
More than $450,000 +7
More than $1,000,000 +8
More than $2,250,000 +9
More than $4,500,000 +10
More than $10,000,000 +11
More than $50,000,000 +12
More than $100,000,000 +13
More than $250,000,000 +14
More than $550,000,000 +15
92 18 U.S.C. app. § 792 (2015).
93 552 U.S. 85, 108–09 (2007).
94 To adjust for inflation, we relied on the Bureau of Labor Statistics consumer price index,
under which prices in 2020 are 125% higher than average prices in 1987. CPI Inflation Calculator,
U.S. BUREAU OF LABOR STATISTICS, https://www.bls.gov/data/inflation_calculator.htm. We then
rounded each figure up or down to a round figure.
C.Agnello SE 0410
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 414 of 569 PageID #:
608
630 OHIO STATE JOURNAL OF CRIMINAL LAW Vol: 18.2:605
Notably, in April 2013 the American Bar Association’s Criminal Justice
Section assembled a Task Force on the Reform of Federal Sentencing for Economic
Crimes to draft a model economic crime guideline that would reflect the chorus of
concerns raised by judges and commentators.95 The Task Force consisted of five
professors,96 three judges,97 six practitioners,98 two organizational representatives,99
and observers from the Department of Justice and the Federal Defenders.100 The
group arrived at a consensus final proposal for the Commission’s consideration in
November 2014.101 Our proposal herein aligns significantly with the loss table
recommendations made by this Task Force.102 While our proposed loss table has
more levels, the enhancements at each loss level closely correspond with those
proposed by the Task Force.103 Further, while the Task Force’s proposed loss table
95 A Report on Behalf of the ABA Criminal Justice Section, Task Force on the Reform of Federal
Sentencing for Economic Crimes, Final Draft, AMERICAN BAR ASS’N 8 (Nov. 10, 2014),
https://www.americanbar.org/content/dam/aba/publications/criminaljustice/economic_crimes.pdf.
96 Stephen Salzburg (George Washington University Law School), Sara Sun Beale (Duke
University School of Law), Nancy Gertner (Harvard Law School), Jane Ann Murray (University of
Minnesota Law School), and Kate Stith (Yale Law School). AMERICAN BAR ASS’N, supra note 95, at
8.
97 The Honorable John Gleeson (Eastern District of New York), the Honorable Gerard Lynch
(Second Circuit), and the Honorable Jed Rakoff (Southern District of New York). AMERICAN BAR
ASS’N, supra note 95, at 8.
98 James Felman (Kynes, Markman & Felman), Reporter to the Task Force, Barry Boss (Cozen
O’Connor) (author herein), David Debold (Gibson Dunn & Crutcher), Gary Lincenberg (Bird, Marella,
Boxer, Wolpert, Nessim, Brooks & Lincenberg), Marjorie Peerce (Ballard Spahr), and Neal Sonnett
(Neal R. Sonnett, P.A.). AMERICAN BAR ASS’N, supra note 95, at 8.
99 Kyle O’Dowd (National Association of Criminal Defense Lawyers) and Mary Price
(Families against Mandatory Minimums). AMERICAN BAR ASS’N, supra note 95, at 8.
100 A.J. Kramer (District of Columbia) and Jonathan Wroblewski (DOJ Office of Policy and
Legislation). AMERICAN BAR ASS’N, supra note 95, at 8.
101 AMERICAN BAR ASS’N, supra note 95, at 9.
102 We recognize that the ABA proposed guideline focused not solely on loss, as our proposal
does, but rather also incorporated enhancements based on relative culpability and victim impact. We
appreciate the benefit of this approach and the loss table proposed herein is not offered as a criticism
of that more holistic approach. Rather, it is offered as a recognition that the ABA proposed guideline
would require a complete overhaul of Section 2B1.1 and has not mustered sufficient support to foment
meaningful change to the current Guideline. As our more modest proposal works within the structure
of the existing Guideline and would simply restore the loss table to its empirical roots, our hope is that
this proposal could generate broader support for meaningful reform.
103 For example, the ABA Task Force proposed a 4-level increase for a $20,000 loss, compared
with our proposed 3-level increase for the same. The Task Force proposed a 6-level increase for a
$100,000 loss, compared with our proposed 5-level increase for the same. Likewise, the Task Force
proposed an 8-level increase for a $1 million loss, which is the same recommendation contained in our
table. The Task Force likewise proposed a 10-level increase for a $5 million loss, which is the same as
our recommendation for a $4.5 million loss. Our table, however, adds a few additional increments at
the end to incorporate the highest loss levels reflected in the most recent version of the Section 2B1.1
loss table. AMERICAN BAR ASS’N, supra note 95, at 1.
C.Agnello SE 0411
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 415 of 569 PageID #:
609
2021 HOW THE ECONOMIC LOSS GUIDELINE LOST ITS WAY 631
was not anchored in empirical data,104 its proposed loss enhancements correspond
closely to those in our table, which is anchored in the empirically based 1987 loss
table. Importantly, the Task Force applied its proposed loss table—with similar
enhancement levels to our own—to a number of case scenarios, which reassured the
Task Force that the proposed loss enhancements “placed appropriate weight on the
consideration[] of loss . . . .”105
The Commission’s recent launch of the Interactive Data Analyzer presents a
unique opportunity to revisit those Guidelines not anchored in empirical data and
analyze the degree to which such Guidelines result in unwarranted sentencing
disparities. The findings contained in this Article reveal troubling sentencing
disparities under Section 2B1.1 and provide a compelling reason for the Commission
to re-evaluate the design of Section 2B1.1’s loss table. We believe that similar
analyses should be undertaken with respect to the drug offense Guidelines, which
were likewise not anchored in empirical data.106 The release of this new data,
moreover, presents an important opportunity for the Commission to revisit the Task
Force’s 2014 recommendations for Section 2B1.1, as well as those offered herein
and by other commentators. Should the release of the Interactive Data Analyzer
serve as a catalyst for meaningful reform, the Commission will have the opportunity
to rebuild the judiciary’s faith in Section 2B1.1. If it succeeds in doing it, it may
finally restore the loss Guideline’s fidelity to its animating purpose of minimizing
unwarranted sentencing disparities.
104 AMERICAN BAR ASS’N, supra note 95, at 9.
105 AMERICAN BAR ASS’N, supra note 95, at 9.
106 See, e.g., Kimbrough v. United States, 552 U.S. 85, 96 (2007).
C.Agnello SE 0412
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 416 of 569 PageID #:
610
EXHIBIT U
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0413
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 417 of 569 PageID #:
611
Boston University Law Review
🔎
Rehabilitation Under the
Rehabilitation Act: The Case
for Medication-Assisted
Treatment in Federal
Correctional Facilities
Jaclyn S. Tayabji*
101 B.U. L. Rev. Online 79 (2021)
PDF
Abstract
Incarcerated individuals are situated at the cross section of two destructive and deadly
epidemics: mass incarceration and the opioid epidemic. The continuing legacy of the war on
drugs is readily apparent in correctional facilities, where the incarcerated population
disproportionately exhibits signs of substance use disorder. More than half of the incarcerated
population meets the diagnostic criteria for drug dependence. Thus, after decades of racialized
and punitive antidrug policies, the most vulnerable individuals, those with opioid use disorder
(“OUD”), are behind bars, where they are blocked from the rest of society and from the most
effective forms of medical treatment. Although medication-assisted treatment (“MAT”) is a
proven effective treatment for OUD, incarcerated individuals are often denied access to such
C.Agnello SE 0414
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 418 of 569 PageID #:
612
medication as a matter of prison policy, putting them at increased risks of recidivism, relapse,
and overdose death upon release.
This Note argues the United States Bureau of Prisons (“BOP”) is violating Section 504 of the
Rehabilitation Act of 1973 (“Rehab Act”) by discriminating on the basis of disability. BOP largely
prohibits the use of MAT for the long-term treatment of OUD for nonpregnant individuals, and it
fails to conduct an individualized assessment into whether an accommodation to provide MAT
is reasonable. These policies and practices deprive incarcerated individuals with OUD
meaningful access to the prison’s medical services on the basis of their disabilities. Although it
appears that BOP is taking steps to implement a voluntary MAT program, its rollout is far too
slow and lacks the key planning details necessary to provide MAT in an effective and timely
manner to eligible incarcerated individuals. The number of individuals receiving MAT in BOP
custody still drastically trails the number of incarcerated individuals in need of this medication,
and it is still uncertain who will be eligible to receive it. Accordingly, BOP’s current and
foreseeable failure to provide reasonable accommodations to incarcerated individuals with OUD
violates the Rehab Act and directly conflicts with Department of Justice initiatives to combat
discriminatory barriers to treatment for OUD.
The failure to provide MAT to treat OUD is not only a disability justice issue but also a criminal
justice issue, a public health issue, and a racial justice issue. It is crucial to hold BOP to the
standards espoused in the Rehab Act and to advocate for broader policy changes regarding
incarcerated individuals with OUD before more lives are needlessly lost to this treatable disease.
Introduction[1]
People are dying from a treatable disease. In 2018, more than 68,000 people in the United
States lost their lives to drug overdoses.[2] In 2019, this number rose to nearly 71,000 people,
[3] with over 70% of overdose deaths involving an opioid.[4] These are not just statistics;
every day, 136 people in the United States die from opioid overdoses.[5] These high death tolls
contributed to a lower life expectancy in the United States for three years in a row,[6] even
before the 2019 novel coronavirus disease (“COVID-19”) devastated communities of color[7]
and resulted in the greatest single-year drop in life expectancy in at least forty years.[8] The
COVID-19 pandemic exacerbated the existing opioid epidemic,[9] healthcare disparities,[10]
and other systemic inequities.[11] As a result, in the United States, May 2019 to May 2020 saw
C.Agnello SE 0415
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 419 of 569 PageID #:
613
the highest number of overdose deaths ever recorded in a twelve-month period: over 81,000.
[12]
The drop in life expectancy during the COVID-19 pandemic correlates with structural inequity,
affecting individuals with marginalized identities the most: life expectancy decreased 3 years
for Latinx people, 2.1 years for Black people, and 0.68 years for White people.[13] Racial
inequity and increased susceptibilities to the COVID-19 pandemic are perhaps most apparent
in the country’s overcrowded jails and prisons,[14] where the COVID-19 pandemic has
exacerbated poor conditions, taxed resources, and placed incarcerated individuals at
heightened risk of overdose death upon release.[15] Incarcerated individuals are situated at
the cross section of the opioid epidemic and mass incarceration. It is crucial to address
incarcerated individuals’ heightened vulnerabilities before more lives are needlessly lost.
Mass incarceration is the inevitable aftermath of decades of prosecuting people of color,
particularly Black individuals,[16] under the “war on drugs.”[17] Although its practices
continue to the present day, the phrase war on drugs commonly refers to a series of racialized
and punitive antidrug policies[18] from the 1970s to the 1990s that purported to address the
overall drug problem in the United States but instead focused on “mass hysteria over crack
cocaine” in communities of color.[19] War on drugs legislation classified substances into
different “schedules” under the Controlled Substances Act,[20] imposed and lengthened
mandatory minimum sentences for drug offenses,[21] and expanded federal drug regulatory
agencies like the Drug Enforcement Administration (“DEA”),[22] directly targeting only
communities of color.[23] Some of the most devastating policies from the war on drugs
involved the criminalization of drug use during pregnancy,[24] which uniquely oppressed
Black women because of the intersection of their identities as Black people and as women.[25]
The plight of people of color as a result of the drug crisis of the 1980s did not elicit the same
levels of public sympathy as the perceived White opioid crisis has today,[26] nor has it
resulted in the same recovery support social services.[27] Instead of receiving such support,
Black people were incarcerated for drug offenses. As Michelle Alexander notes, “[m]ore
African American adults are under correctional control today—in prison or jail, on probation or
parole—than were enslaved in 1850, a decade before the Civil War began.”[28]
The war on drugs met its goal; the number of people incarcerated for drug offenses increased
from 40,900 to 430,926 between 1980 and 2019.[29] The United States now has the highest
incarceration rate in the world,[30] with people of color and individuals with other
C.Agnello SE 0416
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 420 of 569 PageID #:
614
marginalized identities disproportionately represented in this population.[31] Today, the
incarcerated population includes the most vulnerable amongst individuals with opioid use
disorder (“OUD”) because they are blocked from the rest of society and, in fact, from the most
effective forms of medical treatment.
Although medication-assisted treatment (“MAT”) is a proven effective treatment for OUD,[32]
as of 2018 only 20% of those with OUD received specialty addiction treatment like MAT.[33]
People of color have historically had even less access to MAT, with one study finding Black
patients had a 77% lower chance of receiving buprenorphine, a specific type of MAT,
compared to White patients.[34] Instead of receiving treatment, many OUD patients are
incarcerated,[35] where they are denied access to MAT as a matter of prison policy and
without any individualized risk assessment.[36] Upon entering custody, OUD patients who
were previously prescribed MAT are often forced to abruptly stop their prescribed
medications, which jeopardizes their long-term recovery, health, safety, and lives by increasing
the risk of relapse—including overdose deaths—and recidivism upon release.[37] The potential
damage from discontinuing treatment is compounded by the other social, health, physical, and
emotional factors prevalent within correctional facilities,[38] rendering rehabilitation-focused
intervention crucial at such a vulnerable time. Potentially thousands of individuals with OUD in
federal custody[39] lack access to prescription medications to treat their OUD or are
prohibited from continuing their treatment. These policies fail to account for individuals’
disabilities and refuse them the concomitant protections and reasonable accommodations
they should be offered.
Many advocates have urged the removal of discriminatory barriers to MAT.[40] This includes
the United States Department of Justice (“DOJ”), which created an entire initiative to target
disability discrimination against individuals with OUD and “to ensure that individuals who have
completed, or are participating in, treatment for [OUD] do not face unnecessary and
discriminatory barriers to recovery.”[41] Section 504 of the Rehabilitation Act of 1973 (“Rehab
Act”)[42] was enacted to prevent disability discrimination by the federal government.[43]
However, disability discrimination is still widespread against individuals with OUD despite
decades of Rehab Act enforcement. The DOJ, and the federal agencies under its control,
including the United States Bureau of Prisons (“BOP”), have not lived up to the ideals
espoused by their representatives[44] or the legal requirements codified in the Rehab Act.[45]
C.Agnello SE 0417
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 421 of 569 PageID #:
615
This Note argues the BOP policies prohibiting the use of MAT for long-term treatment of OUD
violate the Rehab Act by depriving inmates of reasonable accommodations for their
disabilities. Part I will address the severity of this problem, the prevalence of OUD in
correctional facilities, and MAT’s availability as an effective treatment method for OUD. Part II
will summarize case law under the federal Rehab Act and its state and local counterpart, the
Americans with Disabilities Act (“ADA”),[46] addressing some of the counterarguments in
response to reasonable accommodations. Finally, Part III will argue that BOP’s policies are
unlawful as a matter of U.S. federal statutory law under the Rehab Act and that BOP’s policies
must account for individualized assessments of incarcerated individuals with OUD.[47] With
such a high death toll, urgent legal intervention is necessary to hold correctional facilities
accountable and to ensure individuals with OUD receive medical care for their disabilities.
1. The Ongoing Failure to Respond to OUD in Correctional Facilities
A. The Opioid Epidemic and Correctional Facilities
The continuing legacy of the war on drugs is readily apparent in correctional facilities, where
the incarcerated population disproportionately exhibits signs of substance use disorder. More
than half of the incarcerated population meets the diagnostic criteria for drug dependence.
[48] Although the chain of causation is unclear, and a multitude of other factors are at play,
there is also a strong correlation between substance use and criminal activity.[49] For
example, statistics show that nearly two-thirds of nonviolent offenders discharged from
prisons indicated they had been using illegal drugs in the month preceding the offense, and
about 40% reported using drugs at the time of the offense.[50] This link between illicit
substances and crime is especially pertinent when looking at incarceration for drug offenses in
federal correctional facilities. As of December 2017, 46% of the 155,233 federal prisoners in
BOP custody were incarcerated for drug offenses.[51] The impact has not been borne equally;
in 1999, 46% of individuals charged with a federal drug offense were Latinx, and by 2001 over
80% of federal defendants facing crack cocaine charges were Black.[52] Federal prisoners
also generally have longer periods of incarceration than their state counterparts, “reflect[ing]
the higher proportion of trafficking offenders and the more serious drug distribution crimes
that fall under Federal jurisdiction.”[53]
The disproportionate representation of substance use disorder within both state and federal
correctional facilities highlights the need for robust institutional changes to address the
C.Agnello SE 0418
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 422 of 569 PageID #:
616
medical needs of incarcerated individuals, whatever the circumstances of their offense and the
conditions of their incarceration. This disease deserves to be treated like any other chronic
medical condition, including through the provision of effective medical treatment where
reasonable accommodations so warrant.
B. Medication-Assisted Treatment
1. MAT Is a Critical Part of the Solution to the Opioid Epidemic
Recent clinical studies have demonstrated that MAT is an effective treatment method for OUD.
[54] The two forms of MAT addressed in this Note, methadone and buprenorphine,[55] are
“opioid agonists”—opioids that bind to the brain’s opioid receptors, preventing the uptake of
other opioid particles, such as from heroin or fentanyl.[56] These medications allow patients
to pursue normal activities of daily living without the debilitating drug cravings or negative
repercussions of illicit drug use.[57] An overwhelming consensus in the medical community
endorses MAT as an effective treatment method for OUD, and several renowned organizations
and government officials have recommended its use in correctional facilities.[58]
Regulations and guidelines governing MAT recognize that the best practices for the treatment
of OUD involve individualized assessments into each patient’s needs, including their medical
histories, other medications, and complicating factors.[59] As such, a “formulaic policy
generically applied to all patients meeting specific criteria or in specific situations without
evaluation by a physician or other qualified healthcare provider” is unacceptable.[60] This
individualized assessment suggests certain individuals may be on MAT for several years or
indefinitely, “just as persons with other chronic medical conditions, like diabetes, may need to
take medication regularly throughout their lives.”[61] Longer-term MAT treatment also
renders successful treatment outcomes more likely.[62] However, despite this guidance,
correctional facilities often categorically prohibit MAT as a long-term treatment method for
incarcerated individuals.
2. Correctional Facilities Fail to Provide MAT for OUD
a. Institutional Policies
C.Agnello SE 0419
Case 2:24-cr-00366-NJC Document 24-1Filed 03/11/26 Page 423 of 569 PageID #:
617
Despite evidence suggesting that methadone and buprenorphine are some of the most
effective treatment methods for OUD in correctional facilities,[63] treatment programs for
incarcerated individuals rarely include MAT. Rather, out of the nation’s 5,100 jails and prisons,
“fewer than 30, according to the federal Bureau of Justice Assistance, offer opioid users the
most proven method of recovery: administering methadone or buprenorphine.”[64] BOP
facilities provide substance use treatment through drug education courses, nonresidential
“drug abuse treatment,”[65] residential “drug abuse treatment,”[66] and community
transition treatment.[67] More than half of BOP facilities[68] operate a residential drug
treatment program, in which eligible incarcerated individuals are separated from the general
prison population and provided a therapeutic model of treatment based on cognitive
behavioral therapy.[69] However, for the most part, MAT is not offered as part of this
treatment program.[70]
BOP policies only enumerate “three approved uses” in which methadone is permitted within
federal correctional facilities[71]: (1) longer-term treatment of opiate addicted pregnant
inmates,[72] (2) short-term detoxification of opiate addicted inmates,[73] and (3) treatment
of severe pain.[74] Correctional facilities that administer methadone for opioid treatment,
including pregnancy and detoxification, must abide by federal standards.[75] On a positive
note, BOP has recently launched a MAT trial program for incarcerated individuals, and recent
litigation against BOP has forced its hand in settlement agreements.[76] However, this
piecemeal and defensive response fails to move the needle toward protecting all individuals
with OUD incarcerated in its prisons.
b. Obstacles to Policy Change
Courts have also been slow to make changes affecting incarcerated individuals’ medical needs
and substance use disorder in particular, and several obstacles impede challenging
correctional facilities’ prohibitions of MAT as disability discrimination. Section II of this Note
addresses legal issues that disability discrimination claims under the Rehab Act face.[77]
However, there are several nonlegal obstacles that render policy change more difficult.
First, there is a cultural view that prisoners should be punished and lose their rights during
incarceration. In this view, “[l]awful incarceration brings about the necessary withdrawal or
limitation of many privileges and rights, a retraction justified by the considerations underlying
our penal system.”[78] Second, courts often defer to prison administrations to formulate
C.Agnello SE 0420
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 424 of 569 PageID #:
618
policies within correctional facilities,[79] as the “complex and intractable” problems in
correctional facilities are “not readily susceptible of resolution by decree.”[80] This means
that “courts will accept patently absurd justifications for practices like isolation, and will give
medical evidence far less weight in prison cases than in cases outside the prison context.”[81]
Lastly, MAT is a relatively new area of research, and there is widespread misunderstanding
about MAT and the nature of OUD as a disease.[82] Accordingly, prison officials at various
levels of the institution often harbor misguided stereotypes[83] about MAT and its role in
treating OUD.[84] These individuals may be averse to MAT out of principle.
3. 3. Recent Shifts in Thinking About MAT
a. In Prisons
MAT is “inching its way into jails and prisons,”[85] although this change is slow and with
significant limitations. For example, state prisons and jails have paved the way for MAT
programs treating incarcerated individuals with OUD[86]—including individuals who were
previously prescribed MAT and who first received MAT during incarceration. Additionally,
Massachusettslaunched a pilot program to provide MAT in select jails and prisons across the
state.[87] Massachusetts is also home to the first jail to become a licensed opioid treatment
program (“OTP”) in the country[88]: “I think it’s working,” correctional officer Lee Terrell said
about the in-jail OTP program.[89] “I think violence in the facility has gone down. We used to
get a lot [of medication] through the mail; there used to be a lot of contraband. That has come
to minimal, if anything.”[90] Initial research looking at some of these state initiatives
demonstrates its success.[91]
Outside of its approved uses, BOP has begun to explore the use of MAT for longer-term
treatment. BOP began this inquiry by providing naltrexone[92] as an inmate is transitioned
back to the community.[93] In fiscal year 2018, BOP planned to expand this trial MAT program
for approximately 160 offenders released in the Boston, Massachusetts area,[94] and BOP
officials have said that, as of January 2020, “eligible inmates incarcerated in all of BOP’s
institutions have access to naltrexone.”[95] However, naltrexone has traditionally had lower
success rates than buprenorphine and methadone,[96] and, despite the importance of
providing MAT in a “patient-centered” manner,[97] BOP’s inquiry into other forms of MAT has
been far too late, limited, and slow to implement. Fortunately, in fiscal year 2019, BOP
implemented a new voluntary MAT program for incarcerated individuals with OUD,[98] which
C.Agnello SE 0421
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 425 of 569 PageID #:
619
combines cognitive behavioral therapy with methadone, buprenorphine, and naltrexone
treatment.[99] However, despite goals to expand the program, BOP “lacks key planning
elements to ensure this significant expansion is completed in a timely and effective
manner.”[100] Accordingly, the author operates under the assumption that BOP facilities will
not see a widespread MAT program for several years.
b. In Courts
Recent litigation and investigative efforts under the ADA[101] and Rehab Act evidence shifts in
legal thought, suggesting that the failure to provide MAT in correctional facilities may
constitute disability discrimination. Although enacted later, the ADA was modeled after the
Rehab Act and is interpreted in similar ways.[102] Therefore, legal shifts under both disability
discrimination statutes evidence the likelihood of success in future Rehab Act litigation, even
though none have yet to affirmatively recognize a violation of the ADA or Rehab Act.
First, at least two trial courts have granted preliminary injunctions requiring correctional
facilities to provide MAT where plaintiffs brought ADA claims for disability discrimination
based on refusal to provide the medication.[103] Importantly, the legal standard for
preliminary injunction requires a sufficient likelihood of success on the merits of the claim,
combined with both a strong balance of harms and a public interest in favor of the plaintiff.
[104] Both courts found a sufficient likelihood of success on the merits of the disability
discrimination claim.[105]
Second, the DOJ launched an initiative to remove discriminatory barriers to treatment for
individuals with OUD, under which “[t]he [ADA] provides one of the many tools that the [DOJ]
can and does use to expand access to recovery for individuals addicted to opioids.”[106]
Under this initiative, the DOJ reached successful settlement agreements against employers
and businesses that discriminated against individuals using MAT.[107] As part of these
agreements, the facilities adopted nondiscrimination policies, agreeing “not [to] deny services
on the basis of disability, including opioid use disorder, or apply standards or criteria that
screen out individuals with disabilities.”[108] Although both agreements settled claims under
Title III of the ADA in the context of public accommodations, these agreements provide
important examples of disability discrimination against MAT users and show the DOJ’s explicit
position on this issue.
C.Agnello SE 0422
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 426 of 569 PageID #:
620
In 2018, the U.S. Attorney’s Office for the District of Massachusetts also began an investigation
into whether the Massachusetts Department of Corrections’ failure to provide MAT was a
possible ADA violation.[109] The investigation noted that “all individuals in treatment for OUD,
regardless of whether they are inmates or detainees, are already protected by the ADA, and
that the [Massachusetts Department of Corrections] has existing obligations to accommodate
this disability.”[110] Although the U.S. Attorney’s Office has not concluded whether the
Massachusetts Department of Corrections violated the ADA, the mere existence of this
investigation suggests movement in the legal landscape surrounding disability discrimination
against MAT users.
Third, lawsuits alleging disability discrimination for a correctional facility’s failure to provide
MAT have resulted in favorable settlements requiring the defendant to provide MAT. In Smith
v. Fitzpatrick,[111] the plaintiff had been in recovery using physician-prescribed MAT for over
five years prior to his incarceration, and the correctional facility’s policy prohibiting MAT would
have forced him into acute withdrawal when he reported to prison.[112] Under the settlement
agreement, the Maine Department of Corrections agreed to continue providing Smith with
medication while in state custody.[113]
BOP has not been immune from disability discrimination litigation. BOP recently settled three
separate lawsuits to provide MAT to incarcerated individuals and allowed the plaintiffs to
continue MAT while incarcerated.[114] Although settlements do not necessarily admit to a
statutory violation, BOP officials acknowledged that its new MAT program began in part as a
response to “several lawsuits regarding the provision of MAT to federal inmates.”[115] Clearly,
disability discrimination litigation has spurred policy shifts that will continue to benefit more
incarcerated individuals with OUD as the MAT program is expanded. However, until every
eligible incarcerated individual with OUD can receive MAT, BOP is discriminating on the basis
of disability and jeopardizing the lives and well-being of its incarcerated population.
C. MAT in Correctional Facilities Is Crucial
BOP has a “responsibility to provide inmates with opportunities to participate in programs that
can afford them the skills they need to lead crime-free lives after release. The BOP’s
philosophy is that release preparation begins the first day of imprisonment.”[116]
Policymakers on both sides of the ideological spectrum embrace successful prisoner reentry
as a “rational policy goal” for decision-making within correctional facilities.[117] However,
C.Agnello SE 0423
Case 2:24-cr-00366-NJC Document 24-1Filed 03/11/26 Page 427 of 569 PageID #:
621
BOP’s current treatment programs for substance use disorder fail to live up to this
responsibility.[118] BOP’s failure to provide MAT renders an incarcerated individual further
vulnerable to recidivism and overdose death upon release,[119] among other risks.[120] This
also affects the broader community; because substance use disorder devastates communities
everywhere,[121] albeit in different ways,[122] adequate medical care within prisons will lead
to better health outcomes in the community.[123] As such, “we cannot speak of the health of
the nation without also addressing the health of individuals in prisons, jails and other
institutions.”[124] It is crucial to intervene in the correctional facility context and treat OUD
using scientifically proven pharmacological treatment methods.[125]
Failure to provide MAT in correctional facilities reduces incarcerated individuals’ potential to
successfully reintegrate into the community and renders them more likely to relapse to illicit
substance use and criminal activity. Incarcerated individuals already exhibit high recidivism
rates.[126] However, given the large proportion of incarcerated individuals with substance use
disorder or dependence and the correlation between illicit substance use and criminal activity,
[127] there is likely a connection between relapse to substance use and recidivism after
release. This is especially apparent where an individual was already on the path to recovery
through the use of MAT prior to their incarceration but was forced to stop their prescribed
medication.[128] On the other hand, providing MAT within correctional facilities would allow
the most effective treatment method to reach those in need and would give them the
opportunity to build upon a period of recovery prior to release. This medical intervention
places an individual in a position to most successfully reenter the community without
returning to criminal activity after release.[129]
The failure to provide MAT in correctional facilities also increases an incarcerated individual’s
likelihood of overdose death. Overdose is already the leading cause of death for individuals
recently released from prison.[130] Recently released individuals are significantly more likely
to die from an overdose or related fatality in the first two weeks following release from prison,
compared to the general population.[131] This is because, after a period of forced abstinence
without adequate medical treatment, an incarcerated individual who returns to the community
will have a significantly lower tolerance to substances and be susceptible to other factors
affecting overdose risk. On the other hand, MAT is correlated with a reduced risk of mortality in
the weeks following release,[132] and prisoners who continue their previously prescribed MAT
throughout incarceration have better outcomes than those who are forced to discontinue MAT
C.Agnello SE 0424
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 428 of 569 PageID #:
622
during incarceration.[133] Providing MAT in jails and prisons saves lives. Fortunately, the
movement to offer MAT in correctional facilities is only growing stronger.[134]
1. II. Disability Discrimination Under the Rehab Act
A. The Rehab Act
The Rehab Act protects against disability discrimination in a range of contexts. It states that
“[n]o otherwise qualified individual with a disability” shall, “solely by reason of her or his
disability, be excluded from the participation in, be denied the benefits of, or be subjected to
discrimination” by any program receiving federal funding or conducted by a federal Executive
agency.[135] To establish a claim under the Rehab Act, an individual must establish that they
are (1) an “individual with a disability,” (2) who is “otherwise qualified,” (3) and “excluded from
the participation in, . . . denied the benefits of, or . . . subjected to discrimination,” (4) “solely by
reason of her or his disability.”[136] In assessing the elements of this legal claim, case law
“under the Rehab[] Act [is] precedent for cases under the ADA, and vice-versa,”[137] because
the statutes are interpreted in similar ways and generally provide the same statutory rights,
procedures, and remedies to covered individuals.[138] These rights, procedures, and remedies
are available for “prisoners who bring litigation concerning access to medical care . . . .”[139]
For purposes of the Rehab Act, an individual has a disability if he or she “has a physical or
mental impairment that substantially limits one or more major life activities, has a record of
such an impairment, or is regarded as having such an impairment.”[140] Although individuals
currently engaging in illegal drug use are excluded,[141] an individual is still entitled to
protection under the Rehab Act if they are no longer engaging in illegal drug use, including if
they participate in a supervised rehabilitation program.[142] Additionally, an argument can be
made that individuals currently engaging in illicit drug use should still qualify for reasonable
accommodations for medical treatment. The Rehab Act specifically prohibits discrimination on
the basis of current illegal drug use for purposes of programs and activities providing health
services if the individual is otherwise entitled to such services.[143]
An individual with a disability is otherwise qualified for a program, service, or activity “who is
able to meet all of a program’s requirements in spite of his [disability].”[144] The DOJ’s
regulations reinforce this holding by articulating that an otherwise qualified individual is one
“who meets the essential eligibility requirements [with respect to any DOJ program, service, or
C.Agnello SE 0425
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 429 of 569 PageID #:
623
activity] and who can achieve the purpose of the program or activity” without “fundamental
alteration[s].”[145] The ADA and Rehab Act apply to correctional facilities,[146] and this
guarantee of indiscriminate service includes medical care provided to the incarcerated
population.[147]
There appears to be a circuit split as to whether an individual can bring a claim for reasonable
accommodation for medical services, where the medical services would be for the disabling
condition itself.[148] Second, Seventh, and Tenth Circuit cases suggest an individual cannot
bring such a claim; in this view, they are not “otherwise qualified” because they would not be
eligible for the medical services absent the disability.[149] However, these cases invoke the
disavowed idea that a person with a disability can only demonstrate discrimination through
comparison to a person without a disability,[150] and they predate the Supreme Court’s
important decision in United States v. Georgia.[151]
In Georgia, a paraplegic prison inmate alleged disability discrimination based on the state
prison’s deliberate refusal to accommodate his disability-related needs.[152] The Court said
that “it is quite plausible that the alleged deliberate refusal of prison officials to accommodate
[plaintiff’s] disability-related needs in such fundamentals as . . . medical care . . . constituted
[an ADA violation].”[153] However, the issue was whether the plaintiff’s claims under Title II of
the ADA against the state prison could abrogate state sovereign immunity. The Court held that
abrogation of state sovereign immunity was valid, because the Title II claims alleged deliberate
indifference to accommodate the plaintiff and would independently violate the Eighth
Amendment, as incorporated against the states by the Fourteenth Amendment.[154]
However, the Court also noted in dicta that the plaintiff could potentially assert Title II claims
“premised on conduct that does not independently violate the Fourteenth Amendment” by
rising to the Eighth Amendment’s deliberate indifference standard.[155] Although abrogation
of state sovereign immunity is not at issue when challenging BOP practices, Georgia is
important because the Court explicitly voiced that an ADA violation may be based on
discrimination in a prison’s medical care.[156]
In Kiman v. New Hampshire Department of Corrections,[157] the First Circuit took a different
approach from the aforementioned circuits and cited Georgia to reach its conclusion.[158] In
Kiman, a former state inmate alleged that prison officials had violated the ADA by failing to
properly treat his amyotrophic lateral sclerosis or provide reasonable accommodations for his
disability.[159] The First Circuit found there was a triable issue of fact as to the ADA claim
C.Agnello SE 0426
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 430 of 569 PageID #:
624
where the prison officials failed to provide prescription medication on a regular basis,
suggesting the denial of medical services or medication may constitute a plausible legal claim
for discrimination.[160]
Thus, Kiman likely demonstrates that failure to provide medical care post-Georgia is a
legitimate basis for a disability claim under the ADA.[161] Accordingly, a prisoner bringing a
reasonable accommodation claim based on medical services to treat the prisoner’s underlying
disability should be “otherwise qualified” for such services. Because “[a]ccess to prescription
medications is part of a prison’s medical services,” it is a service covered by the ADA.[162]
An otherwise-qualified individual with a disability may be discriminated against in a number of
ways,[163] including through intentional discrimination, disparate impact, and failure to make
a reasonable accommodation.[164] An entity discriminates by failing to make a reasonable
accommodation if they know of an individual’s disability[165] and they fail to implement
reasonable accommodations to their policies, practices, and procedures that otherwise
deprive an individual of “meaningful access” to the program or activity.[166] For example, an
individual may be deprived of meaningful access to prison medical services if they lack access
to effective treatment, including if they are denied access to “the only form of treatment
shown to be effective at managing [the individual’s] disability.”[167] An ADA or Rehab Act
claim based on the failure to provide a reasonable medical accommodation must go beyond
mere disagreement with a particular course of treatment or inadequate medical care but must
demonstrate that the policy amounts to discrimination.[168] With regards to prescription
medications, some courts have indicated that the complete denial of access to medications is
not “a medical ‘judgment’ subject to differing opinion—it is an outright denial of medical
services.”[169]
Lastly, discrimination may be based on an individual’s disability if it rests on stereotypes about
the disabled and is not based on “an individualized inquiry into the patient’s condition.”[170]
Pesce v. Coppinger[171] highlights that per se rejections of treatment options may violate the
ADA because they lack the requisite individualized analysis.[172] In Pesce, the plaintiff had
achieved two years of recovery from his OUD using methadone and sought an injunction to
continue this medication during incarceration at Essex County Jail. Prior to methadone, Pesce
had unsuccessfully tried other treatment methods for his OUD,[173] and his physician warned
that he was not yet ready to taper off of his medication.[174] The court found the jail’s policy
prohibiting opioids like buprenorphine and methadone precluded an individualized assessment
C.Agnello SE 0427
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 431 of 569 PageID #:
625
or consideration of Pesce’s specific medical needs.[175] Therefore, the court found Pesce was
likely to succeed on the merits of his disability discrimination claim and granted a preliminary
injunction allowing Pesce to continue MAT in jail.[176]
This is distinguishable from Kiman, where the court found defendants’ decisions regarding
Kiman’s medical treatment did not violate the ADA because “prison medical staff sought
[Kiman’s] medical records” and “arranged an outside specialist consultation” before
determining the “types of treatment and physical therapy that they thought were appropriate
in his case.”[177] Accordingly, prison officials did conduct an individualized assessment into
Kiman’s medical needs, and they had latitude to decide how to treat his conditions. Thus, both
Pesce and Kiman highlight the need for an individualized assessment when a reasonable
accommodation request pertains to medical services.
B. Affirmative Defenses to a Rehab Act Claim
A covered entity does not need to take any and all actions to accommodate individuals with
disabilities. For example, a covered entity is required only to make accommodations that are
reasonable, depending on the specific individual, context, and type of accommodation
requested. Additionally, a covered entity does not need to make changes that would cause a
“fundamental alteration in the nature of a program or activity.”[178]
Southeastern Community College v. Davis[179] first interpreted the Rehab Act and articulated
an entity’s obligation to modify policies, practices, or procedures through a reasonable
accommodation.[180] Davis dealt with whether the Rehab Act’s prohibition on discrimination
against an otherwise qualified individual with a disability forbade a professional school from
imposing physical qualifications for admission to its clinical training programs.[181] The Court
found that, due to the nature of the respondent’s disability, “nothing less than close, individual
attention by a nursing instructor would be sufficient to ensure patient safety if respondent
took part in the clinical phase of the nursing program.”[182] Further, respondent’s absence
from the clinical program would require the College to implement vast curricular changes, with
little benefit to respondent.[183] Accordingly, the Court held that “[s]uch a fundamental
alteration in the nature of a program is far more than the ‘modification’ the regulation
requires.”[184]
C.Agnello SE 0428
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 432 of 569 PageID #:
626
Therefore, the Rehab Act’s prohibition of disability discrimination against an otherwise
qualified individual with a disability by a federally funded program does not extend to an
individual who, in order to meet reasonable eligibility standards, needs program or policy
modifications that would fundamentally alter the nature of the entity’s program. Although
institutions are still required to make reasonable accommodations based on an individualized
inquiry,[185] drawing a line before changes cause fundamental alterations preserves the
“balance between the statutory rights of the [individual with a disability] to be integrated into
society and the legitimate interests of federal grantees in preserving the integrity of their
programs.”[186]
A covered entity is also spared from making accommodations that would pose “undue
financial and administrative burdens.”[187] The entity must demonstrate the expected
financial and administrative burdens render an accommodation unreasonable, rather than
merely speculating about foreseeable challenges.[188]
Lastly, a covered entity does not need to make accommodations for an individual that poses a
“direct threat” or “significant health and safety risks” to others, because an individual who
poses a direct threat would not be otherwise-qualified for the service or activity.[189] This
direct threat analysis must be individualized and grounded in current medical or other
objective scientific knowledge, rather than generalizations or stereotypes about the disability.
[190] In the prison context, prison administrators undoubtedly face “unique circumstances
and challenges” that contribute to overall safety and security considerations.[191] Pertinent
security concerns include fear of drug diversion and prisoner safety.[192]
Because of these unique safety and security concerns, prison officials may infringe on
prisoners’ constitutional rights as long as the discriminatory policies are “reasonably related to
legitimate penological interests” in safety and security.[193] Turner v. Safley[194] examined
these circumstances to determine whether two prison policies infringing prisoners’
constitutional rights were permissible or whether they represented an “exaggerated response
to the claimed security objectives.”[195] Although striking down a regulation infringing the
fundamental right to marry, the Court upheld a regulation prohibiting correspondence
between inmates that was logically connected to the prison’s security concerns.[196] The
Court deferred to prison officials’ implementation of such a policy, paying particular attention
to the balance between prisoners’ rights and corresponding threats to the prison’s core
functions.[197]
C.Agnello SE 0429
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 433 of 569 PageID #:
627
Turner focused on constitutional rights, and the scope of statutory rights were not at issue. It
is unclear whether Turner’s analysis for balancing legitimate penological interests applies to
statutory rights like those under the Rehab Act in the same way as constitutional rights.[198]
However, some courts have still considered variables from Turner in determining whether
infringement of prisoners’ statutory rights are permissible in furtherance of safety and
security interests.[199] These variables include “security and cost”[200] and
“maintaining . . . order[,] and operating an institution in a manageable fashion.”[201]
At the very least, the direct threat analysis in the correctional facility context must identify
“specific” security concerns that arise when an individual requests an accommodation.[202]
This analysis cannot rely on past instances of concern, “generalizations or scientifically
unsupported assumptions about MAT or persons who receive MAT for [OUD].”[203] Where
there are no “medical or individualized security considerations underlying the decision to deny
access to medically necessary treatment,” a discriminatory policy is either “‘arbitrary or
capricious-as to imply that it was the pretext for some discriminatory motive’ or
‘discriminatory on its face.’”[204]
III. The BOP’s Current Practices
Violate the Rehab Act
The Rehab Act applies to BOP because DOJ regulations expressly prohibit disability
discrimination in programs or activities conducted by the DOJ.[205] Because there is
uncertainty about the long-term plans for BOP’s new MAT program, the precise contours of a
Rehab Act claim are unclear.
BOP purports that its MAT program will provide MAT “based on individuals’ needs” and as
clinically determined by a health care professional,[206] presumably affording individualized
assessments to incarcerated individuals with OUD. However, while BOP has provided
naltrexone to all eligible incarcerated individuals in BOP institutions as of December 2019, its
expansion to include methadone and buprenorphine is far too slow and underinclusive. The
number of individuals receiving methadone and buprenorphine[207] still drastically trails the
number of incarcerated individuals in need of this medication. Accordingly, BOP’s current and
foreseeable failure to provide reasonable accommodations for incarcerated individuals
violates the Rehab Act.
C.Agnello SE 0430
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 434 of 569 PageID #:
628
Additionally, while BOP is taking steps to provide methadone and buprenorphine, it is
uncertain who will be eligible to receive it. BOP officials expect these medications to be
provided “on a case-by-case basis—generally, if an inmate is already receiving either
medication upon entering BOP custody.”[208] This limitation seems to be a practical response
to the liability BOP has faced through its categorical denial of medical care, and, as of January
2020, BOP had not finalized draft clinical guidance for the MAT program. Accordingly, while
the author is encouraged by BOP’s policy shifts and its apparent recognition that OUD is a
disease deserving of—and requiring—adequate medical care, litigators in this space may soon
need to refocus their attention. Future advocacy must include the urgent need for BOP to
provide MAT to all incarcerated individuals with OUD who want the treatment, regardless of
whether they were previously prescribed MAT prior to incarceration.
A. Challenging BOP Policies Under the Rehab Act
Federally incarcerated individuals with OUD are clearly individuals with a disability under the
Rehab Act.[209] As additional evidence, the aforementioned trial court cases and settlement
agreements alleging discrimination against MAT users do not contest that the plaintiffs are
qualified individuals under the ADA.[210] Although individuals are not covered on the basis of
“psychoactive substance use disorders resulting from current illegal use of drugs,”[211]
individuals fall within the Rehab Act’s protection once they are no longer using illegal drugs.
[212]
Incarcerated individuals who were not previously prescribed MAT will have to overcome the
statutory hurdle to establish that they are not currently using illegal substances. The Rehab
Act excludes from its protections only individuals who are currently using illegal substances
“when a covered entity acts on the basis of such use.”[213] Circuits differ as to how long a
plaintiff must abstain from substance use to regain the protection of disability discrimination
statutes—in other words, how much time is needed to believe that the plaintiff is no longer
using illicit substances and is thus worthy, in the legislature’s view, of statutory protection.
[214]
It is worth considering the various options: (1) an individual may seek MAT immediately upon
entering the facility, or (2) they may wait a period of time and seek MAT during the term of
their incarceration. The first option would prevent the needless pain and suffering that results
from forced withdrawal from substances. However, the individual may have a harder time
C.Agnello SE 0431
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 435 of 569 PageID #:
629
establishing that they have “been rehabilitated successfully and [are] no longer engaging in
such use.”[215] An individual’s progress toward achieving sobriety, if any, may suffice to show
they have made efforts at drug rehabilitation,[216] but many individuals with OUD will likely
use illicit substances up until the point of incarceration. For those individuals, the Rehab Act
provides that, notwithstanding the exception for individuals currently engaging in illegal drug
use, “an individual shall not be excluded from the benefits of such programs or activities
[providing health services and services provided under Titles I, II, and III] on the basis of his or
her current illegal use of drugs if he or she is otherwise entitled to such services.”[217] Courts
have not yet interpreted how this provision will apply when individuals with OUD seek medical
care.[218]
Incarcerated individuals with OUD are otherwise qualified for medical services, including
prescription medication.[219] Although the existing circuit split may lead to different
outcomes,[220] the First Circuit’s approach in Kiman suggests an individual with OUD can
bring a Rehab Act claim when they are denied medical treatment for their disability.[221] This
need is particularly acute when an individual with OUD is completely denied access to
prescription medications they otherwise would have received in the community,[222] and
when MAT has been shown to be the only effective treatment method.[223] An incarcerated
individual’s MAT prescription should be treated like other prescription medications in a
correctional facility[224]: “If they’re sick with kidney or heart disease, we give them the
treatment and medication. If they’re sick with addiction, we should give them the treatment
and medication for that.”[225] Just like other inmates receive necessary treatment for their
medical conditions, eligible incarcerated individuals with OUD should receive MAT as a
reasonable accommodation during their incarceration, regardless of their treatment status
prior to incarceration.
However, BOP precludes “meaningful access” to a prison’s medical services when it fails to
conduct an individualized inquiry into a reasonable accommodation to provide MAT.[226] For
individuals who were previously prescribed MAT, BOP becomes aware of their disability upon
intake into the prison at which time BOP learns about the individual’s prescription
medications.[227] Although BOP does allow MAT prescription for short-term detoxification,
[228] BOP’s policies largely deny medication for long-term treatment of OUD for nonpregnant
individuals.[229] These individuals would otherwise be able to receive long-term MAT
treatment in the community, and this may be the only effective treatment method for their
OUD.[230] A request for a reasonable accommodation to receive MAT while incarcerated does
C.Agnello SE 0432
Case 2:24-cr-00366-NJC Document 24-1Filed 03/11/26 Page 436 of 569 PageID #:
630
not suggest mere disagreement with BOP’s substance treatment programs; it challenges the
complete denial of this scientifically proven treatment method for incarcerated individuals.
[231] This is especially crucial for incarcerated individuals, like the plaintiff in Pesce, who have
previously tried, unsuccessfully, other treatment methods for their OUD.[232] For other
incarcerated individuals, it is crucial to provide meaningful access to BOP’s medical services in
order to intervene in the cycle of relapse, recidivism, and overdose death.[233]
BOP’s policies discriminate on the basis of an incarcerated individual’s OUD because, while
other individuals are provided necessary medical care, those who suffer from OUD potentially
lack any opportunity to treat their disease while incarcerated, and BOP fails to make an
individualized assessment into whether an accommodation to provide MAT is reasonable.
[234] This need for individualized assessment applies to whether MAT is allowed, the proper
dosage, the duration of treatment, the types of medication, and other factors inherent in a
complicated medical decision. BOP’s failure to conduct an individualized inquiry precludes
individual consideration of an inmate’s specific medical needs[235] and indicates that BOP
likely bases this policy decision on stereotypes about MAT and individuals with OUD. As such,
BOP’s policy—without an individualized assessment for all incarcerated individuals with OUD—
constitutes discrimination on the basis of disability.[236]
B. Affirmative Defenses to Rehab Act Claim Do Not Justify BOP Policies
BOP’s progress toward a MAT program demonstrates that reasonable accommodations are
feasible. However, the slow rollout of BOP’s MAT program and its uncertain future mean that
BOP’s current practices continue to categorically deny MAT to incarcerated individuals. BOP
must also expand the scope of its individualized assessments to include individuals who were
not previously prescribed MAT prior to incarceration to avoid future disability discrimination
litigation.
An accommodation to provide MAT to incarcerated individuals would not cause a fundamental
alteration to BOP medical services. One of the most common reasons that correctional
facilities do not provide MAT is preference for “drug-free treatment.”[237] However, BOP’s
policy requiring MAT for pregnant incarcerated individuals, allowing facilities to provide MAT
for detoxification, and its plans to provide MAT for longer-term treatment demonstrate that
drug-free treatment is not a core aspect of BOP’s program. Further, the requisite
individualized inquiry into whether an accommodation is reasonable tends to screen out cases
C.Agnello SE 0433
Case 2:24-cr-00366-NJC Document 24-1
Filed 03/11/26 Page 437 of 569 PageID #:
631
where the requested accommodation would fundamentally alter the nature of the prison
program.[238] Therefore, accommodations to allow MAT treatment in BOP correctional
facilities would not fundamentally alter the nature of BOP’s programs or services. To the
contrary, such treatment would actually advance BOP’s purposed policy goals to promote
rehabilitation and reentry into the community.[239]
Additionally, an accommodation to provide MAT to incarcerated individuals would not cause
an undue financial or administrative burden. MAT is a cost-efficient method to treat OUD.[240]
This treatment method also reduces recidivism, which will lead to reduced prison populations
and costs associated with incarceration.[241] Programs with a smaller number of inmates
receiving MAT will have higher per-patient costs.[242] However, BOP has a large number of
federal inmates who will qualify for reasonable accommodations, which is already motivating
large-scale policy changes to ensure staff training, proper medication storage, and a
streamlined process. Additionally, BOP’s approved uses of methadone suggest there are likely
policies and procedures already in place to guarantee its safe storage and registration
requirements,[243] and BOP is taking steps to further streamline its procedures to dispense
MAT. BOP’s MAT program is possible in part because of recent legislative and policy initiatives
that provide funds to implement MAT programs.[244] The continuing availability of these
funds moving forward will alleviate any short-term financial burden for BOP to implement the
policies and practices to provide MAT to all incarcerated individuals with OUD. Overall, while
providing MAT will involve an upfront investment, this necessary shift will pay off in the long
run as recidivism decreases and widespread policies become more normalized.
Lastly, incarcerated individuals do not pose a sufficient direct threat to safety and security that
would justify this failure to make a reasonable accommodation. One of the biggest
counterarguments in response to MAT is fear of diversion—passing on prescription medication
to other individuals—within the correctional facility.[245] However, this fear underlying BOP’s
prohibitory policy is not realistic and is often based on stereotypes about MAT and those with
substance use disorder. For example, in Cudnik v. Kreiger,[246] an illicit market for methadone
in the jail was “at best highly remote” because the jail administered methadone according to
strict regulations and in liquid form, under the supervision of a licensed clinician.[247]
Additionally, the plaintiff’s request in Smith v. Aroostook County[248] to continue MAT during
her incarceration “was not unreasonable, as evidenced by the fact that the Defendants
previously provided the same accommodation to a pregnant inmate without issue and by the
Defendants’ acknowledgement that they could grant the requested exemption in a way that
C.Agnello SE 0434
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 438 of 569 PageID #:
632
would obviate any security concerns.”[249] Additionally, correctional facilities around the
country demonstrate that MAT treatment programs are feasible without significant safety
concerns.[250]
BOP provides MAT to pregnant incarcerated individuals and for extended periods to treat
severe pain, and now to treat certain incarcerated individuals with OUD. These medications
may be stored in bulk with other controlled substances,[251] or incarcerated individuals may
continue to be driven outside of the correctional facility to receive MAT. As such, proper
security measures will prevent the diversion of prescription medications.[252] Even where
there are legitimate concerns, assessment of risks undercutting an accommodation request
must be made on an individualized basis for all incarcerated individuals affected by this
disease.[253]
Conclusion
BOP’s violation of the Rehab Act directly conflicts with the DOJ’s stated initiative to combat
discriminatory barriers to treatment for OUD.[254] BOP’s discriminatory barriers to treatment
“[u]nlawfully deny[] services to individuals with disabilities because of their medical
conditions” and “subject[] these individuals to unwarranted stigma and harm.”[255] Although
Assistant Attorney General Eric Dreiband said these discriminatory barriers “will not be
tolerated by the Department of Justice,”[256] DOJ’s complicity in discriminatory practices
against federally incarcerated individuals with OUD suggests otherwise.
Even with BOP’s new MAT program in the works, the legal community should effectuate the
purpose underlying the Rehab Act by recognizing widespread disability discrimination against
incarcerated individuals with OUD. Many state and local correctional institutions still prohibit
MAT as a matter of policy. Additionally, the future of BOP’s MAT program is uncertain. It is
unclear who will receive MAT under BOP’s new MAT program and when they will receive it. If
the legal community does not enforce the Rehab Act in this context, we also run the risk that
BOP may, at some point in the future, walk back its policies and practices with changing
leadership. Fortunately, for now, it appears that BOP is in the process of applying for and
receiving certification to dispense MAT at its facilities,[257] although correctional facilities
may take several possible routes to provide MAT that differ in the level of planning and
licensing requirements.[258]
C.Agnello SE 0435
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 439 of 569 PageID #:
633
The failure to provide MAT to incarcerated individuals is disability discrimination. It is also a
criminal justice issue, a public health issue, and a racial justice issue. If BOP truly serves a
rehabilitative purpose, as purported by its policies, its failure to provide MAT to incarcerated
individuals with OUD is far from ideal. Rather, the limited availability of MAT threatens
incarcerated individuals’ ability to maintain recovery during incarceration and build necessary
life skills to maintain post-release recovery. Current substance treatment options in federal
prisons fail BOP’s mandate to prepare individuals for release by precluding the use of
medically effective pharmacological treatment without an individualized assessment.
As we address the effects of the war on drugs, it is especially important to account for the
drastically disproportionate burden borne by communities and individuals of color throughout
the history of drug use prosecutions. Otherwise, any policy to address the opioid epidemic will
continue to marginalize those whose suffering is compounded by other forms of oppression
and discrimination. Thus, “the problem of race and opioids cannot stop with expansion of
access to treatment.”[259] Any policies that only provide reasonable accommodations for
individuals who were previously prescribed MAT before incarceration will likely exclude people
of color who already face barriers to recovery. Outside of correctional facilities, policymakers
can only effectively address the opioid epidemic by considering the ways in which culture,
resources, stigma, and interactions with other systems, such as the criminal justice system,
affect an individual’s experiences with OUD and the pathways to recovery that are available to
them.[260]
Any and all improvements to the treatment of incarcerated individuals with OUD are crucial.
The author hopes that lawyers and courts will continue to pressure BOP to effectuate policy
changes by recognizing the failure to provide MAT as the disability discrimination it is. From
there, advocacy must continue to address the vulnerabilities and needs of all individuals with
OUD in light of the disproportionate criminalization of people of color for drug offenses, the
inequitable access to community-based treatment, and the history of racialized responses to
drug crises in this country. The only way to meaningfully address the opioid crisis is to reach
those most in need and to specifically account for the multitude of ways substance use
disorder is treated differently depending on one’s identity, resources, and location. By
addressing OUD in correctional facilities, policymakers have the opportunity to reach those
who are most physically isolated from community-based treatment and who
disproportionately come from underresourced communities. We must urgently shift
C.Agnello SE 0436
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 440 of 569 PageID #:
634
perspectives and responses before the death toll continues to climb, leaving in its wake the
memory of those whom this country’s institutions, laws, and policies have failed.
*J.D., Boston University School of Law, 2021; B.A. International Studies and African Studies,
Emory University, 2016. My deepest gratitude goes to Professor Robyn Powell for her guidance
throughout the Note process and to Professor Naomi Mann, Kelsey Scarlett, Lexi Weyrick,
Muhammad Mustafa, Julia Sakamoto, Sarah Kula, and the Boston University Law Review
editorial team—especially Kaela Dunn and Emily Rothkin—for their advice, support, and
commitment to improving this Note. I am humbled by this opportunity and recognize how
many miracles it took to get here. This Note is dedicated to all those who fight the disease of
addiction one day at a time and in memory of those for whom social progress comes too late.
[1]Given the “increasing evidence of a close relationship between the use of language and the
perpetuation of stigma,” the author uses the language “medication-assisted treatment”
(“MAT”) and “opioid use disorder” (“OUD”), rather than “substance abuse.” Daniel Z.
Buchman, Pamela Leece & Aaron Orkin, The Epidemic as Stigma: The Bioethics of Opioids, 45
J.L. Med. & Ethics 607, 608 (2017). At the time of writing, these terms are generally accepted
as medically accurate and nonstigmatizing terms. However, there have been and likely will
continue to be significant shifts in acceptable terminology. The author welcomes the
continuing progress towards nonstigmatizing, medically accurate, and person-first language
when discussing substance use. See Sean M. Robinson, “Alcoholic” or “Person with Alcohol Use
Disorder”? Applying Person-First Diagnostic Terminology in the Clinical Domain, 38 Substance
Abuse 9, 9 (2017).
[2]See Abby Goodnough, Josh Katz & Margot Sanger-Katz, Drug Overdose Deaths Drop in U.S.
for First Time Since 1990, N.Y. Times (July 17, 2019),
https://www.nytimes.com/interactive/2019/07/17/upshot/drug-overdose-deaths-fall.html.
With 68,557 overdose deaths in the United States, 2018 saw the first decline in annual
overdose deaths since 1990. See id. However, “[t]he decline was due almost entirely to a dip in
deaths from prescription opioid painkillers, the medicines that set off the epidemic of
addiction that has lasted nearly two decades. Fatal overdoses involving other drugs,
particularly fentanyl and methamphetamine, continued to rise.” Id. Additionally, research
shows that official statistics could underrepresent the true opioid death toll by at least 20%,
C.Agnello SE 0437
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 441 of 569 PageID #:
635
suggesting these are conservative estimates. See Christopher J. Ruhm, Geographic Variation
in Opioid and Heroin Involved Drug Poisoning Mortality Rates, 53 Am. J. Preventive Med. 745,
745 (2017) (finding corrected opioid and heroin involved mortality rates were 24% and 22%
greater, respectively, than reported statistics).
[3]Understanding the Epidemic, CDC (Mar. 17, 2020), https://www.cdc.gov/drugoverdose/
epidemic/index.html [https://perma.cc/SN6T-PJPP].
[4]Id.
[5]Id.
[6]Jessica Pishko, The Repurposing of the American Jail, Atlantic (Nov. 19, 2019),
https://www.theatlantic.com/politics/archive/2019/11/going-jail-substance-abuse-
treatment/602206/.
[7]See Maria Godoy & Daniel Wood, What Do Coronavirus Racial Disparities Look Like State by
State?, NPR (May 30, 2020, 6:00 AM), https://www.npr.org/sections/health-
shots/2020/05/30/865413079/what-do-coronavirus-racial-disparities-look-like-state-by-
state [https://perma.cc/QT2J-H3RC]. Not only are Black, Latinx, and Native people more
likely to contract COVID-19, but they are also 2.4, 1.5, and 1.5 times more likely to die from
COVID-19 than White people, respectively. See Daniel Wood, As Pandemic Deaths Add Up,
Racial Disparities Persist—and in Some Cases Worsen, NPR (Sept. 23, 2020, 1:01 PM),
https://www.npr.org/sections/health-shots/2020/09/23/914427907/as-pandemic-deaths-
add-up-racial-disparities-persist-and-in-some-cases-worsen [https://perma.cc/KU2D-XHKS].
[8]Robert Glatter, Life Expectancy in the U.S. Sees Largest Decline in Decades After Covid-19,
Forbes (Jan. 24, 2021, 12:04 PM), https://www.forbes.com/sites/robertglatter
/2021/01/24/life-expectancy-in-the-us-sees-largest-decline-in-decades-after-covid-19/?
sh=40719663706f.
[9]Press Release, CDC, Overdose Deaths Accelerating During COVID-19 (Dec. 17, 2020),
https://www.cdc.gov/media/releases/2020/p1218-overdose-deaths-covid-19.html
[https://perma.cc/6546-6NYY]; see also Hilary Swift & Abby Goodnough, ‘The Drug Became
His Friend’: Pandemic Drives Hike in Opioid Deaths, N.Y. Times (July 14, 2021),
https://www.nytimes.com/2020/09/29/health/coronavirus-opioids-addiction.html
C.Agnello SE 0438
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 442 of 569 PageID #:
636
(describing impact of COVID-19 pandemic, including isolation, barriers to seeking medication-
assisted treatment, lack of social support services, and economic insecurity, as contributing to
spike in overdose deaths); Emma Goldberg, ‘Relapsing Left and Right’: Trying to Overcome
Addiction in a Pandemic, N.Y. Times (Jan. 4, 2021), https://www.nytimes.com/2021/01/04
/nyregion/addiction-treatment-coronavirus-new-york-new-jersey.html (describing shutdown
of treatment facilities for substance use disorder during COVID-19 pandemic).
[10]See Keon L. Gilbert, Ruqaiijah Yearby, Amber Johnson & Kira Banks, Opinion, For Black
Americans, Covid-19 Is a Reminder of the Racism of US Healthcare, Guardian (Feb. 22, 2021,
4:42 PM), https://www.theguardian.com/commentisfree/2021/feb/22/black-americans-
covid-19-racism-us-healthcare. Failures in our healthcare system have contributed to the
opioid epidemic. See Nicolas P. Terry, Structural Determinism Amplifying the Opioid Crisis: It’s
the Healthcare, Stupid!, 11 Ne. U. L. Rev. 315, 371 (2019) (“[I]t is not difficult to suggest some
relevant flaws that rise to the level of structural determinants [of the opioid epidemic]: access
and benefit stratification, the changing role of Medicaid, problems associated with
fragmentation of care (the lack of behavioral health services integrated into our primary care
systems cannot be overemphasized), and the lack of wraparound services.”).
[11]See Gina Kolata, Social Inequities Explain Racial Gaps in Pandemic, Studies Find, N.Y. Times
(July 27, 2021), https://www.nytimes.com/2020/12/09/health/coronavirus-black-
hispanic.html (noting systemic inequities that contribute to disproportionate impact of COVID-
19 pandemic on communities of color include greater workplace exposure in lower-income
jobs, multigenerational housing, reduced access to healthcare, and elevated rates of
underlying health conditions); Sabrina Strings, Opinion, It’s Not Obesity. It’s Slavery., N.Y.
Times (May 25, 2020), https://www.nytimes.com/2020/05/25/opinion/coronavirus-race-
obesity.html (describing how slavery “set in motion” systemic inequities that continue today).
[12]See CDC, supra note 9. Preliminary data for 2020 as a whole are even more stark; over
93,000 people died from drug overdoses in the U.S. in 2020, a jump of approximately 30%
from the preceding year. See Bill Chappell, Drug Overdoses Killed a Record Number of
Americans in 2020, Jumping by Nearly 30%, NPR (July 14, 2021, 6:53 PM),
https://www.npr.org/2021/07/14/1016029270/drug-overdoses-killed-a-record-number-of-
americans-in-2020-jumping-by-nearly-30 [https://perma.cc/PG36-N3H8].
[13]Chappell, supra note 12.
C.Agnello SE 0439
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 443 of 569 PageID #:
637
[14]See Beth Schwartzapfel, Katie Park & Andrew DeMillo, 1 in 5 Prisoners in the U.S. Has Had
COVID-19, Marshall Project (Dec. 18, 2020, 6:00 AM),
https://www.themarshallproject.org/2020/12/18/1-in-5-prisoners-in-the-u-s-has-had-covid-
19 [https://perma.cc/P6MQ-M3TX] (noting positive test rate for COVID-19 in prisons is more
than four times higher than positive test rate of general population).
[15]See Joseph Longley, As Overdoses Spike During Coronavirus, Treating Addiction in Prisons
and Jails Is a Matter of Life and Death, ACLU: News & Comment. (July 22, 2020),
https://www.aclu.org/news/prisoners-rights/as-overdoses-spike-during-coronavirus-
treating-addiction-in-prisons-and-jails-is-a-matter-of-life-and-death/
[https://perma.cc/MS7A-TU4G].
[16]See Dorothy E. Roberts, The Social and Moral Cost of Mass Incarceration in African
American Communities, 56 Stan. L. Rev. 1271, 1274-76 (2004). The unique experiences of
Black women, who are disproportionately represented in jails and prisons, are often
overlooked in conversations about mass incarceration. See Priscilla A. Ocen, Unshackling
Intersectionality, 10 Du Bois Rev. 471, 472 (2013) (“The growth in the prison population has
been led by the incarceration of Black women, who are three times as likely as White women to
be incarcerated, often for nonviolent, drug-related offenses. The impact wrought by the mass
incarceration of Black women cannot be overstated.”).
[17]See A Brief History of the Drug War, Drug Pol’y All.,
http://www.drugpolicy.org/issues/brief-history-drug-war [https://perma.cc/JE3Y-793M]
(last visited Sept. 1, 2021). Because of war on drugs policies, the total prison population
increased from fewer than 300,000 people in the early 1970s to more than 2.2 million
incarcerated and 4.5 million more on probation or parole in 2019. See Bryan Stevenson,
Slavery Gave America a Fear of Black People and a Taste for Violent Punishment. Both Still
Define Our Criminal-Justice System., N.Y. Times Mag. (Aug. 14, 2019),
https://www.nytimes.com
/interactive/2019/08/14/magazine/prison-industrial-complex-slavery-racism.html. The war
on drugs has also cost the United States more than $1 trillion. See German Lopez, The War on
Drugs, Explained, Vox (May 8, 2016, 1:21 PM),
https://www.vox.com/2016/5/8/18089368/war-on-drugs-marijuana-cocaine-heroin-meth.
Additionally, despite probation and parole being viewed as alternatives to incarceration, these
“alternative” sentences are feeding mass incarceration. In 2018, 28% of state and federal
C.Agnello SE 0440
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 444 of 569 PageID #:
638
prison admissions stemmed from violations of parole and probation. See Revoked: How
Probation and Parole Feed Mass Incarceration in the United States, Hum. Rts. Watch (July 31,
2020), https://www.hrw.org/report/2020/07/31/revoked/how-probation-and-parole-feed-
mass-incarceration-united-states [https://perma.cc/AP9R-WL24]. People of color are
disproportionately represented in the population of individuals on probation; in particular,
Black people account for 30% of adult probationers, despite comprising only 13% of the U.S.
population. See Jesse Jannetta, Justin Breaux, Helen Ho & Jeremy Porter, Urb. Inst.,
Examining Racial and Ethnic Disparities in Probation Revocation 1 (Apr. 2014),
https://www.urban.org/sites/default/files/publication/22746/413174-Examining-Racial-and-
Ethnic-Disparities-in-Probation-Revocation.PDF [https://perma.cc/PST2-8EXH]. The risk of
incarceration through probation revocation directly impacts individuals with OUD, as
substance-free probation requirements often view relapse as a violation of their terms. See,
e.g., Commonwealth v. Eldred, 101 N.E.3d 911, 921-22, 924-25 (Mass. 2018) (holding that,
although “relapse is a part of recovery,” trial judge did not abuse discretion by concluding
defendant’s relapse was “wilful” violation of drug-free probation).
[18]See Courtney Lauren Anderson, Opioids Are the New Black, 69 DePaul L. Rev. 55, 69-70
(2019) (describing how “mass hysteria over crack cocaine” fueled targeted policies in inner-
city Black communities).
[19]See id. at 66-68, 70 (describing epidemic of crack and cocaine use in 1980s and racist
origins of criminalizing drug use). However, at the same time, these policies did not target a
simultaneous rise in cocaine use in affluent White communities. See ACLU, Cracks in the
System: Twenty Years of the Unjust Federal Crack Cocaine Law i-ii (2006) (discussing stark
100-to-1 sentencing disparity between crack, which was more accessible to poor and Black
Americans, and powder cocaine, which was more commonly used by affluent White
Americans, despite current scientific understanding that crack is no more harmful than
powder cocaine).
[20]See German Lopez, The Federal Drug Scheduling System, Explained, Vox (Aug. 11, 2016,
9:05 AM), https://www.vox.com/2014/9/25/6842187/drug-schedule-list-marijuana.
[21]See Opposing Mandatory Minimums, Equal Just. Under L.,
https://equaljusticeunderlaw.org/mandatory-minimums-1 [https://perma.cc/X69X-B4V6]
(last visited Sept. 1, 2021).
C.Agnello SE 0441
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 445 of 569 PageID #:
639
[22]See Thirty Years of America’s Drug War, PBS: Frontline,
https://www.pbs.org/wgbh/pages/frontline/shows/drugs/cron/ [https://perma.cc/7788-
GSK2] (last visited Sept. 1, 2021).
[23]Racial Double Standard in Drug Laws Persists Today, Equal Just. Initiative (Dec. 9, 2019),
https://eji.org/news/racial-double-standard-in-drug-laws-persists-today/
[https://perma.cc/UNB3-QKLN]. The statistics tell the story of the disproportionate impact
on communities of color. See Aaron Williams, The Full Story of the 1980’s Crack Epidemic Is
Still Yet to Be Told, Uproxx (June 26, 2017), https://uproxx.com/hiphop/snowfall-1980s-
crack-epidemic/ [https://perma.cc/8F2A-XHPR] (comparing statistics that, in 1991, 15% of
crack users were Black but 79% of sentenced crack offenders were Black, whereas 52% of
crack users were White but only 10% of sentenced crack offenders were White); see also
Keturah James & Ayana Jordan, Law and the Opioid Crisis: An Inter-Disciplinary Examination:
The Opioid Crisis in Black Communities, 46 J.L. Med. & Ethics 203, 410 (2018) (discussing
harsher sentencing penalties for crack use compared to powder cocaine use).
[24]See Khiara M. Bridges, Race, Pregnancy, and the Opioid Epidemic: White Privilege and the
Criminalization of Opioid Use During Pregnancy, 133 Harv. L. Rev. 770, 815-21 (2020)
(discussing disproportionate prosecutions of Black women for substance use during
pregnancy, which “began in earnest during the crack cocaine scare in the 1980s”).
[25]See Julie B. Ehrlich, Breaking the Law by Giving Birth: The War on Drugs, the War on
Reproductive Rights, and the War on Women, 32 N.Y.U. Rev. L. & Soc. Change 381, 387 (2008)
(“[T]he War on Drugs became a war on women of color, with prosecutions of pregnant women
focusing on those women who used crack cocaine, a drug predominantly found in low-income
communities of color.”). However, today, arrest and prosecution trends for women who use
substances while pregnant track the demographics of the opioid epidemic as a whole: “[A]s
white people predominate among those struggling with opioid use, misuse, and dependence,
white women predominate among those who have faced criminal charges for opioid use during
pregnancy.” See Bridges, supra note 24, at 776 (footnote omitted) (arguing that White privilege
failed to protect White women who have been prosecuted for opioid use during pregnancy
“because these women possess a compromised, marginalized, ‘not-quite’ whiteness—a
corrupted whiteness that has yielded to them a reduced racial privilege”).
C.Agnello SE 0442
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 446 of 569 PageID #:
640
[26]See German Lopez, The Deadliness of the Opioid Epidemic Has Roots in America’s Failed
Response to Crack, Vox (Oct. 5, 2017, 9:45 AM),
https://www.vox.com/identities/2017/10/2/16328342/opioid-epidemic-racism-addiction
(comparing differences between media response of today and that of the 1980s and 1990s).
The current opioid crisis has affected significantly more White and affluent individuals than
previous iterations of drug crises, and “the narrative around the opioid epidemic has
emphasized th[ese] high numbers of white casualties across the nation” to the detriment of
people of color. James & Jordan, supra note 23, at 406; see Julie Netherland & Helena B.
Hansen, The War on Drugs That Wasn’t: Wasted Whiteness, “Dirty Doctors,” and Race in Media
Coverage of Prescription Opioid Misuse, 40 Culture Med. Psychiatry 664, 674 (2016)
(comparing media portrayal of opioid crisis depicting Black and Latinx individuals as using
heroin and White individuals as using prescription opioid painkillers, thus “leav[ing] the [White
individuals] blameless or at least sympathetic to the reader”); Jasmine Drake, Creaque
Charles, Jennifer W. Bourgeois, Elycia S. Daniel & Melissa Kwende, Exploring the Impact of the
Opioid Epidemic in Black and Hispanic Communities in the United States, Drug Sci. Pol’y & L.,
2020 at 1 (2020) (“Although there have been significant increases in the number of opioid-
related overdose deaths in Black and Hispanic communities, the media narrative for this
epidemic is often portrayed as a White, Non-Hispanic rural and suburban crisis.”). However,
the opioid epidemic is still the largest drug epidemic in U.S. history for all racial groups. See
James & Jordan, supra note 23, at 405.
[27]See Katharine Q. Seelye, In Heroin Crisis, White Families Seek Gentler War on Drugs, N.Y.
Times (Oct. 30, 2015), https://www.nytimes.com/2015/10/31/us/heroin-war-on-drugs-
parents.html (“When the nation’s long-running war against drugs was defined by the crack
epidemic and based in poor, predominantly black urban areas, the public response was
defined by zero tolerance and stiff prison sentences. But today’s heroin crisis is different.”).
[28]Michelle Alexander, The New Jim Crow, 9 Ohio St. J. Crim. L. 7, 9 (2011).
[29]The Sent’g Project, Trends in U.S. Corrections 3 (2021),
https://www.sentencingproject.org/wp-content/uploads/2021/07/Trends-in-US-
Corrections.pdf [https://perma.cc/SDF6-WQV6]; see also Sarah E. Wakeman & Josiah D.
Rich, Addiction Treatment Within U.S. Correctional Facilities: Bridging the Gap Between Current
Practice and Evidence-Based Care, 34 J. Addictive Diseases 220, 220 (2015) (“This epidemic of
incarceration is largely due to the ‘War on Drugs,’ which has resulted in criminalization of the
C.Agnello SE 0443
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 447 of 569 PageID #:
641
disease of addiction.”); Fed. Bureau of Prisons, U.S. DOJ, FY 2019 Performance Budget 6
[hereinafter Performance Budget] (noting “changes in interdiction and sentencing [in 1980s
and 1990s] changed the population’s composition” to include greater proportion of drug
offenders).
[30]See Stevenson, supra note 17. Despite accounting for only 4% of the world’s population,
the United States accounts for 22% of the world’s imprisoned population. Id.
[31]For information about U.S. incarceration rates by race and ethnicity, see Leah Sakala,
Breaking Down Mass Incarceration in the 2010 Census: State-by-State Incarceration Rates by
Race/Ethnicity, Prison Pol’y Initiative (May 28, 2014), https://www.prisonpolicy.org
/reports/rates.html [https://perma.cc/8QDP-NLGP]. For information on incarceration rates
of women by race and ethnicity, see Aleks Kajstura, Women’s Mass Incarceration: The Whole
Pie 2019, Prison Pol’y Initiative (Oct. 29, 2019), https://www.prisonpolicy.org
/reports/pie2019women.html [https://perma.cc/M8YR-EB7M]. Additionally, transgender
people are disproportionately incarcerated at rates double those of the general population,
and incarceration rates are even higher for transgender individuals of color and low-income
transgender individuals. See Nat’l Ctr. for Transgender Equal., LGBTQ People Behind Bars 5
(2018), https://transequality.org/sites/default/files/docs/resources
/TransgenderPeopleBehindBars.pdf [https://perma.cc/3VJ4-STAL]. Although this Note
considers “incarcerated individuals” without reference to their particular identities, it is
essential that policies account for individuals’ lived experiences at the intersection of various
identities. See Kimberle Crenshaw, Demarginalizing the Intersection of Race and Sex: A Black
Feminist Critique of Antidiscrimination Doctrine, Feminist Theory and Antiracist Politics, 1989
U. Chi. Legal F. 139, 140 (1989) (“Th[e] focus on the most privileged group members
marginalizes those who are multiply-burdened and obscures claims that cannot be understood
as resulting from discrete sources of discrimination.”).
[32]See Sally Friedman & Melissa Trent, Defense Lawyers and the Opioid Epidemic: Advocating
for Addiction Medication, Champion, Aug. 2018, at 21. See generally Effective Treatments for
Opioid Addiction, Nat’l Inst. on Drug Abuse (Nov. 2016),
https://www.drugabuse.gov/publications/effective-treatments-opioid-addiction/effective-
treatments-opioid-addiction [https://perma.cc/Z83P-WCTD] (“Medications should be
combined with behavioral counseling for a ‘whole patient’ approach, known as Medication
Assisted Treatment.”).
C.Agnello SE 0444
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 448 of 569 PageID #:
642
[33]Elinore F. McCance-Katz, U.S. Dep’t of Health & Hum. Servs., An Update on the Opioid
Crisis 2 (2018), https://www.samhsa.gov/sites/default/files/aatod_2018_final.pdf
[https://perma.cc/2WJ9-TRRP].
[34]Pooja A. Lagisetty, Ryan Ross, Amy Bohnert, Michael Clay & Donovan T. Maust, Research
Letter, Buprenorphine Treatment Divide by Race/Ethnicity and Payment, 76 JAMA Psychiatry
979, 979-80 (2019) (finding growth in buprenorphine to treat OUD “is concentrated among
white persons and those with private insurance or use self-pay”). Several factors may
contribute to disproportionate access to MAT, including cost, access to health care and
insurance, implicit bias, and stigma. See Drake et al., supra note 26, at 8 (“Although each drug
is available only by Rx, for the uninsured, costs may be an issue, particularly with
buprenorphine, as insurances plans often do not cover this drug for opioid abuse disorder.”);
John F. Kelly, Sarah E. Wakeman & Richard Saitz, Editorial, Stop Talking ‘Dirty’: Clinicians,
Language, and Quality of Care for the Leading Cause of Preventable Death in the United States,
128 Am. J. Med. 8, 8 (2015) (describing impact of stigmatizing language on clinical care); Noa
Krawczyk, Kenneth A. Feder, Michael I. Fingerhood & Brendan Saloner, Racial and Ethnic
Differences in Opioid Agonist Treatment for Opioid Use Disorder in a U.S. National Sample, 178
Drug & Alcohol Dependence 512, 513 (2017) (“[B]lack and Hispanic clients have historically
experienced greater barriers to care, less support services and lower quality of care in
substance use services than white clients.”).
[35]See Jennifer Bronson, Jessica Stroop, Stephanie Zimmer & Marcus Berzofsky, U.S. DOJ,
Special Report: Drug Use, Dependence, and Abuse Among State Prisoners and Jail Inmates,
2007-2009, at 1 (2017).
[36]See infra Parts I.A, B.1-2.
[37]See infra Part I.C.
[38]See, e.g., Danielle Wallace & Xia Wang, Does In-Prison Physical and Mental Health Impact
Recidivism?, SSM—Population Health, Aug. 2020, at 1, 1 (discussing impact of physical and
mental health in prison on recidivism rates); Craig Haney, The Psychological Impact of
Incarceration: Implications for Post-Prison Adjustment 2 (Dec. 2001) (unpublished
manuscript) (available at https://aspe.hhs.gov/basic-report/psychological-impact-
incarceration-implications-post-prison-adjustment#III) (describing prisoners’ psychological
C.Agnello SE 0445
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 449 of 569 PageID #:
643
changes as result of “modern prison life” in which “prisons have become more difficult places
in which to adjust and survive over the last several decades”); Nick De Viggiani, Surviving
Prison: Exploring Prison Social Life as a Determinant of Health, 2 Int’l J. Prisoner Health 71, 85
(2006) (“Attitudes and behaviours of prisoners and prison officers commonly reflected
majority values associated with reputation, gender, race and age, which manifested, for
instance, through competitiveness, machismo, violence, heterosexism, homophobia and
racism.”).
[39]As of December 14, 2017, there were 155,233 federal prisoners in BOP custody. See
Performance Budget, supra note 29, at 3.
[40]Some scholars have argued that withholding MAT may even violate the Eighth
Amendment’s prohibition of cruel and unusual punishment. See, e.g., Michael Linden, Sam
Marullo, Curtis Bone, Declan T. Barry & Kristen Bell, The Opioid Epidemic, Medication-Assisted
Treatment, and the Eighth Amendment, 46 J.L. Med. & Ethics 252, 263 (2018); Melissa Koppel,
Note, Medication-Assisted Treatment: Statutory Schemes & Civil Rights Implications, 27
Cardozo J. Equal Rts. & Soc. Just. 145, 162 (2020). Other scholars have argued that
withholding MAT may violate international human rights norms. See, e.g., Shianne Bowlin,
Note, Resolving the Overlooked Tragedy in Correctional Facilities: Medication Assisted
Treatment Access for Inmates, 8 Lincoln Mem’l U. L. Rev. 358, 360 (2020); R. Douglas Bruce &
Rebecca A. Schleifer, Ethical and Human Rights Imperatives to Ensure Medication-Assisted
Treatment for Opioid Dependence in Prisons and Pre-Trial Detention, 19 Int’l J. Drug Pol’y 17, 19-
21 (2008).
[41]Eric Dreiband, Assistant Att’y Gen., U.S. DOJ, Remarks at the Epstein Becker and Green
38th Annual Workforce Management Briefing (Oct. 7, 2019),
https://www.justice.gov/opa/speech/assistant-attorney-general-eric-dreiband-delivers-
remarks-epstein-becker-and-green-38th [https://perma.cc/XWR9-8XZF].
[42]29 U.S.C. § 794(a).
[43]See, e.g., Sanders ex rel. Sanders v. Marquette Pub. Schs., 561 F. Supp. 1361, 1369 (W.D.
Mich. 1983) (“The basic purpose of the Rehabilitation Act is to ensure that handicapped
persons are not discriminated against by recipients of federal funds solely on the basis of their
handicaps. This is plainly stated in 29 U.S.C. § 794 itself.”).
C.Agnello SE 0446
Case 2:24-cr-00366-NJC Document 24-1Filed 03/11/26 Page 450 of 569 PageID #:
644
[44]See supra note 41 and accompanying text.
[45]29 U.S.C. § 794(a).
[46]42 U.S.C. §§ 12101-12111.
[47]Fortunately, BOP is developing and implementing new policies to provide more federally
incarcerated individuals with MAT. See infra notes 92-100 and accompanying text. However,
there are serious concerns with the timing and effectiveness of such a program. U.S. Gov’t
Accountability Off., GAO-20-423, Improved Planning Would Help BOP Evaluate and Manage Its
Portfolio of Drug Education and Treatment Programs 31-34 (2020) [hereinafter Improved
Planning]. Accordingly, the author operates under the assumption that a widespread MAT
program in BOP facilities is still several years away, if at all, and that BOP’s current policies
violate the Rehab Act.
[48]Bronson et al., supra note 35, at 1 (finding 63% of sentenced jail inmates and 58% of state
prisoners met criteria specified in Diagnostic and Statistical Manual of Mental Disorders for
drug dependence or substance use disorder, whereas approximately 5% of adults in general
population met criteria) (citing Am. Psychiatric Ass’n, Diagnostic and Statistical Manual of
Mental Disorders (4th ed., text rev. 2000)).
[49]See Matthew R. Durose & Christopher J. Mumola, U.S. DOJ, Profile of Nonviolent
Offenders Exiting State Prisons 3 tbl.5 (2004) (noting 55.1% of nonviolent offenders had used
either alcohol or drugs at time of offense in 1997). The greater percentage of individuals with
substance use disorder within correctional facilities is not meant to suggest these individuals
are particularly prone to criminal activity or less worthy of protection from disability
discrimination. Rather, these statistics raise questions about whether greater proportions of
incarcerated individuals with substance use disorder suggest that more individuals are using
drugs and committing crimes, or that law enforcement efforts disproportionately target, or
inadequately respond to, individuals with substance use disorder. See Shayla Love, Police Are
the First to Respond to Mental Health Crises. They Shouldn’t Be, Vice (June 23, 2020, 10:00
AM), https://www.vice.com/en/article/3azkeb/police-are-the-first-to-respond-to-mental-
health-crises-they-shouldnt-be; Joseph Goldstein, Undercover Officers Ask Addicts to Buy
Drugs, Snaring Them but Not Dealers, N.Y. Times (Apr. 4, 2016),
https://www.nytimes.com/2016/04/05/nyregion/undercover-officers-ask-addicts-to-buy-
C.Agnello SE 0447
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 451 of 569 PageID #:
645
drugs-snaring-them-but-not-dealers.html. It is also worth mentioning that, despite many Good
Samaritan laws, individuals can face criminal charges for seeking medical care for an
overdose, or, conversely, for fearing criminal charges and not seeking medical care. See Drug
Overdose Immunity and Good Samaritan Laws, Nat’l Conf. State Legislatures (June 5, 2017),
https://www.ncsl.org/research/civil-and-criminal-justice/drug-overdose-immunity-good-
samaritan-laws.aspx [https://perma.cc/RZA4-X2LM]; Tommy Simmons, Case of Ada Man
Who Reported Friend’s Overdose Shows Limits of Idaho’s Good Samaritan Law, Idaho Press
(Sept. 10, 2019), https://www.idahopress.com/news/local/case-of-ada-man-who-reported-
friends-overdose-shows-limits-of-idahos-good-samaritan-law/article_9e495d3b-f8e4-59ce-
99b9-d77b3bfd7adb.html (relating anecdote of man sentenced up to ten years in prison after
reporting friend’s overdose); News Release, U.S. DOJ, Illinois Man Who Removed Evidence
from Opioid Overdose Death Scene Instead of Calling 911 Sentenced to Federal Prison (Aug.
28, 2020), https://www.justice.gov/usao-ndia/pr/illinois-man-who-removed-evidence-opioid-
overdose-death-scene-instead-calling-911 [https://perma.cc/AY8C-MJGD] (announcing
twenty-one-month prison sentence for individual who removed heroin from location of
overdose to prevent law enforcement from finding it). Fortunately, organizations like the Police
Assisted Addiction & Recovery Initiative are changing perspectives on policing and working
with law enforcement to better support, rather than criminalize, individuals with substance use
disorder. See About Us, Police Assisted Addiction & Recovery Initiative,
https://paariusa.org/about-us/ [https://perma.cc/F33Y-FVXD] (last visited Sept. 1, 2021).
[50]Durose & Mumola, supra note 49, at 3 tbl.5.
[51]Performance Budget, supra note 29, at 3-4. Substance use disorder among federal
inmates generally follows the same patterns as state and local counterparts, although drug
offenders are only slightly more likely to show signs of drug dependence than those
incarcerated for other crimes. See Bronson et al., supra note 35, at 3, 3 tbl.2.
[52]See Fatema Gunja, Race and the War on Drugs, ACLU (May 2003),
https://www.aclu.org/other/race-war-drugs?redirect=drug-law-reform/race-war-drugs
[https://perma.cc/YHK5-RKPD].
[53]Christopher J. Mumola & Jennifer C. Karberg, U.S. DOJ, Drug Use and Dependence, State
and Federal Prisoners, 2004, at 4 (2006), https://bjs.ojp.gov/content/pub/pdf/dudsfp04.pdf
[https://perma.cc/S6T6-YPJF].
C.Agnello SE 0448
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 452 of 569 PageID #:
646
[54]See Friedman & Trent, supra note 32, at 21 (summarizing research studies and stating
“[d]ozens of studies have shown that medication-assisted treatment reduces drug use,
disease rates, overdose deaths, and criminal activity among people with opioid use disorder”).
[55]See 42 C.F.R. § 8.2 (2021) (defining use of MAT for long-term maintenance as “the
dispensing of an opioid agonist treatment medication at stable dosage levels for a period in
excess of 21 days in the treatment of an individual for opioid use disorder”). Methadone and
pharmaceutical products containing buprenorphine are opioid agonists approved by the Food
and Drug Administration to treat OUD. See Substance Abuse & Mental Health Servs. Admin.,
Federal Guidelines for Opioid Treatment Programs 4 (2015) [hereinafter Federal Guidelines].
Methadone is usually dispensed in liquid form as a daily dose taken under observation, and it
can only be dispensed to treat substance use disorder at a licensed facility. See Friedman &
Trent, supra note 32, at 21. Buprenorphine, commonly referred to by the brand name
Suboxone, is usually taken as a sublingual strip that dissolves in the mouth, and an individual
usually obtains a thirty-day prescription by specially trained physicians. See id. at 20.
[56]See Friedman & Trent, supra note 32, at 21.
[57]See, e.g., Pesce v. Coppinger, 355 F. Supp. 3d 35, 41 (D. Mass. 2018) (describing
improvement in plaintiff’s quality of life through use of methadone to maintain recovery from
opioid addiction).
[58]See Kyle Kampman & Margaret Jarvis, The American Society of Addiction Medicine
(ASAM) National Practice Guideline for the Use of Medications in the Treatment of Addiction
Involving Opioid Use, 9 J. Addiction Med. 358, 365 (2015) (explicitly recommending MAT
during incarceration); Substance Use Disorder Treatment for Adults and Adolescents, Nat’l
Comm’n on Corr. Health Care (Oct. 23, 2016), https://www.ncchc.org/substance-use-
disorder-treatment-for-adults-and-adolescents [https://perma.cc/WWL9-58HT] (calling for
“continuation of prescribed medications for substance use disorders” within correctional
facilities”). In 2017, President Trump’s Commission on Combating Drug Addiction and the
Opioid Crisis also called for offering MAT in jails and prisons. President’s Comm’n on
Combating Drug Addiction & the Opioid Crisis, Final Report 73 (2017).
[59]See, e.g., 42 C.F.R. § 8.2 (defining MAT as “use of medication in combination with
behavioral health services to provide an individualized approach to the treatment of substance
C.Agnello SE 0449
Case 2:24-cr-00366-NJC Document 24-1Filed 03/11/26 Page 453 of 569 PageID #:
647
use disorder” (emphasis added)); Medication-Assisted Treatment (MAT), Substance Abuse &
Mental Health Servs. Admin. (Jan. 4, 2021), https://www.samhsa.gov/medication-assisted-
treatment [https://perma.cc/DZ9W-WPQL] (defining MAT as use of FDA-approved
medications “in combination with counseling and behavioral therapies, to provide a ‘whole-
patient’ approach to the treatment of substance use disorders” (emphasis added)). 42 C.F.R.
§§ 8.1-.34 (2021) sets federal standards for opioid treatment programs (“OTPs”) and the
Substance Abuse and Mental Health Services Administration’s (“SAMHSA”) Guidelines. See
42 C.F.R. § 8.2; Federal Guidelines, supra note 55 (elaborating on these standards). Although
federal regulation has not changed since its adoption, SAMHSA’s Guidelines suggest how the
regulation should be applied in the context of changing opioid use, healthcare delivery, and
problems impacting public health. Federal Guidelines, supra note 55, at 4-5. The most recent
2015 Guidelines reflect the obligation of OTPs to deliver care consistent with the “patient-
centered, integrated, and recovery-oriented standards of addiction treatment and medical
care in general.” Id. at 6.
[60]Federal Guidelines, supra note 55, at 51.
[61]Letter from Joon H. Kim, Acting U.S. Att’y, S. Dist. of New York, to New York State Off. of
the Att’y Gen. at 4 (Oct. 3, 2017), https://lac.org/wp-content/uploads/2018/02/DOJ-SDNY-
ltr-to-OCA-10.3.17.pdf [https://perma.cc/66L2-SQCM] (citing Substance Abuse & Mental
Health Servs. Admin., Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment
Programs: A Treatment Improvement Protocol 113-17 (2005) [hereinafter Treatment
Improvement Protocol], which recommends “possibly years of treatment” and “optional”
tapering off of medication).
[62]See Wakeman & Rich, supra note 29, at 222 (describing study finding that longer duration
and methadone doses greater than 60 mg are “necessary to see significant health and social
improvement”).
[63]See id. (describing international evidence and precedent supporting MAT treatment
programs at all stages of incarceration). See generally Michael S. Gordon, Timothy W. Kinlock
& Patrice M. Miller, Medication-Assisted Treatment Research with Criminal Justice Populations:
Challenges of Implementation, 29 Behav. Scis. & L. 829 (2011) (surveying studies of MAT’s
effectiveness in correctional facilities).
C.Agnello SE 0450
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 454 of 569 PageID #:
648
[64]Timothy Williams, Opioid Users Are Filling Jails. Why Don’t Jails Treat Them?, N.Y. Times
(Aug. 4, 2017), https://www.nytimes.com/2017/08/04/us/heroin-addiction-jails-methadone-
suboxone-treatment.html. MAT is largely unavailable at all levels of the criminal justice system,
including jails and drug courts. See Friedman & Trent, supra note 32, at 22 (describing 2014
surveys showing half of U.S. drug courts did not permit methadone and other prescription
medications to treat OUD); Christine Vestal, New Momentum for Addiction Treatment Behind
Bars, Pew (Apr. 4, 2018), https://www.pewtrusts.org/en/research-and-
analysis/blogs/stateline/2018/04/04/new-momentum-for-addiction-treatment-behind-bars
(stating that only twenty-two of nation’s 3,300 local jails offer methadone). However, there
have been some changes in the context of drug courts. See U.S. DOJ, Adult Drug Court
Discretionary Grant Program 12 (2018) (requiring drug courts seeking federal grant to permit
MAT).
[65]See supra note 1 and accompanying text (discussing importance of nonstigmatizing
language).
[66]Id.
[67]Performance Budget, supra note 29, at 8.
[68]A full list of BOP prison locations can be found at https://www.bop.gov
/about/facilities/federal_prisons.jsp [https://perma.cc/9GG4-HTXC] (last visited Sept. 1,
2021).
[69]Performance Budget, supra note 29, at 10. In fiscal year 2017, 16,641 prisoners
participated in BOP’s residential drug treatment program. Id.
[70]I specifically chose BOP as the subject of this Note because I was struck by the tension
between DOJ’s opioid initiative and the discriminatory practices within an agency under its
control. DOJ has explicitly endorsed OUD as a disease. See Memorandum from Loretta E.
Lynch, Att’y Gen., Off. of the Att’y Gen., to Heads of Dep’t Components 7 (Sept. 21, 2016),
https://www.justice.gov/opioidawareness/file/896776/download [https://perma.cc/K8QB-
FKY7]. DOJ has also stated that failure to provide MAT may constitute disability
discrimination. See Letter from Andrew E. Lelling, U.S. Att’y, Dist. of Massachusetts, to David
Solet, Gen. Couns., Exec. Off. of Pub. Safety & Sec., and Jesse Caplan, Gen. Couns., Exec. Off.
C.Agnello SE 0451
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 455 of 569 PageID #:
649
of Health & Hum. Servs. 2 (Mar. 16, 2018),
http://d279m997dpfwgl.cloudfront.net/wp/2018/03/20180322172953624.pdf
[https://perma.cc/LW9T-7SAM]. BOP has only started exploring the use of MAT in response
to recent litigation. See Improved Planning, supra note 47, at 23 n.36.
[71]Fed. Bureau of Prisons, U.S. DOJ, Pharmacy Services 37 (2005) [hereinafter Pharmacy
Services], https://www.bop.gov/policy/progstat/6360_001.pdf [https://perma.cc
/HGJ8-Z73A].
[72]Fed. Bureau of Prisons, U.S. DOJ, Patient Care 43 (2014) [hereinafter Patient Care],
https://www.bop.gov/policy/progstat/6031_004.pdf [https://perma.cc/9VE4-DN6S]
(noting inmate should only be detoxified from medication after delivery); see also Substance
Use Disorder Treatment for Adults and Adolescents, supra note 58 (“Opioid withdrawal in
pregnancy can lead to miscarriage, preterm birth, stillbirth, and other adverse outcomes.
Therefore, withdrawal, including medically assisted withdrawal, must be avoided through the
use of MAT.”). Any institution that could “conceivably house pregnant inmates” must have a
“contingency” in place to provide MAT. See Patient Care, supra.
[73]Id. at 25 (giving discretion to local institutions to manage details for detoxifying
incarcerated individuals).
[74]Pharmacy Services, supra note 71, at 39 (noting methadone prescription for severe pain
management does not require methadone license).
[75]Id. at 37; see also 42 C.F.R. § 8.11 (2021) (requiring current valid accreditation, SAMHSA
certification, and DEA registration to dispense opioid drugs for treatment of opioid addiction).
[76]Improved Planning, supra note 47, at 23. BOP officials acknowledged that they started the
MAT program in part because of lawsuits. Id.; see, e.g., ACLU-WA Lawsuit Settled: Federal
Prison System Agrees to Provide Medication-Assisted Treatment for Opioid Use Disorder, ACLU
(Dec. 11, 2019), https://www.aclu.org/press-releases/aclu-wa-lawsuit-settled-federal-prison-
system-agrees-provide-medication-assisted [https://perma.cc/6LLA-SLUQ]; German Lopez,
How America’s Prisons and Jails Perpetuate the Opioid Epidemic, Vox (Jan. 31, 2020, 4:20 PM),
https://www.vox.com/policy-and-politics/2020/1/30/21078618/prison-opioid-epidemic-
buprenorphine-suboxone-methadone.
C.Agnello SE 0452
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 456 of 569 PageID #:
650
[77]See infra Part II.
[78]Price v. Johnston, 334 U.S. 266, 285 (1948), overruled on other grounds by McCleskey v.
Zant, 499 U.S. 467 (1991).
[79]See Andrew Brunsden, Note, Hepatitis C in Prisons: Evolving Toward Decency Through
Adequate Medical Care and Public Health Reform, 54 UCLA L. Rev. 465, 467 (2006) (noting
courts “are hesitant to order expanded access to medical care” in prisons); see also Overton v.
Bazzetta, 539 U.S. 126, 132 (2003) (“We must accord substantial deference to the
professional judgment of prison administrators, who bear a significant responsibility for
defining the legitimate goals of a corrections system and for determining the most appropriate
means to accomplish them.”).
[80]Procunier v. Martinez, 416 U.S. 396, 405 (1974), overruled by Thornburgh v. Abbott, 490
U.S. 401 (1989).
[81]Scott Burris, Prisons, Law and Public Health: The Case for a Coordinated Response to
Epidemic Disease Behind Bars, 47 U. Mia. L. Rev. 291, 324 (1992) (describing court deference
relating to HIV in correctional facilities).
[82]See Peter D. Friedmann, Randall Hoskinson Jr., Michael Gordon, Robert Schwartz,
Timothy Kinlock, Kevin Knight, Patrick M. Flynn, Wayne N. Welsh, Lynda A. R. Stein, Stanley
Sacks, Daniel J. O’Connell, Hannah K. Knudsen, Michael S. Shafer, Elizabeth Hall & Linda K.
Frisman, Medication-Assisted Treatment in Criminal Justice Agencies Affiliated with the
Criminal Justice-Drug Abuse Treatment Studies (CJ-DATS): Availability, Barriers, and
Intentions, 33 Substance Abuse 9, 14 (2012) (showing majority of surveyed sites that did not
provide MAT indicated MAT programs would be possible if evidence showed MAT improved
criminal justice outcomes). Prisons tend to implement policies addressing public health
concerns that have been established and documented for longer periods of time. See
Brunsden, supra note 79, at 472.
[83]There are several harmful stereotypes associated with OUD and MAT. For example, some
think that “addiction is a moral failing, not a medical condition, so public resources shouldn’t
go to treating it.” Lopez, supra note 76. There is also a “myth that [MAT] medications are
simply ‘replacing one drug with another.’” Id. The stigma surrounding OUD is incredibly
C.Agnello SE 0453
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 457 of 569 PageID #:
651
harmful and undermines an individual’s ability to recover and seek medical care, even outside
of the correctional facility context. See Kelly et al., supra note 34. See generally Learn About
Stigma, Shatterproof, https://www.shatterproof.org/our-work/ending-addiction-
stigma/understanding-addiction-stigma [https://perma.cc/A6JU-9H79] (last visited Sept. 1,
2021).
[84]Wakeman & Rich, supra note 29, at 221 (recognizing correctional facilities offering
substance treatment generally provide nonpharmacological options because of antipathy
towards opioid agonists); see also Smith v. Aroostook Cnty., 376 F. Supp. 3d 146, 160 (D. Me.
2019), aff’d, 922 F.3d 41 (1st Cir. 2019) (“The Defendants’ statements and actions
[demonstrating their general attitude towards OUD] suggest the kind of ‘apathetic attitude’
towards individuals with disabilities that the ADA intends to remedy.”).
[85]Friedman & Trent, supra note 32, at 23.
[86]See, e.g., Behavioral Health Services, State R.I. Dep’t of Corr.,
http://www.doc.ri.gov/rehabilitative/healthcare/behavioral/ [https://perma.cc/Q6X2-VARV]
(last visited Sept. 1, 2021) (describing program in Rhode Island Department of Corrections);
Lopez, supra note 76 (describing program in Vermont); Matthew Reisen, BernCo Jail Offers
Methadone Program to Inmates, Albuquerque J. (Nov. 18, 2017, 10:45 PM),
https://www.abqjournal.com/1094949/county-jail-fights-opioid-addiction-from-the-inside-
out.html [https://perma.cc/4K9C-4RKP] (describing program in scenic Bernalillo County,
New Mexico); Christine Vestal, Opioid Treatment at Rikers Island Is a Long-Standing Success,
but Few Jails Adopt It, PBS NewsHour (May 23, 2016, 2:50 PM),
https://www.pbs.org/newshour/nation/opioid-treatment-at-rikers-island-is-a-long-standing-
success-but-few-jails-adopt-it [https://perma.cc/W3JT-GHSC] (describing program in Rikers
Island, New York).
[87]Press Release, Off. of Governor Charlie Baker, Governor Baker Signs Second Major Piece
of Legislation to Address Opioid Epidemic in Massachusetts (Aug. 14, 2018),
https://www.mass.gov/news/governor-baker-signs-second-major-piece-of-legislation-to-
address-opioid-epidemic-in [https://perma.cc/JP69-JB3P].
[88]See Deborah Becker, Franklin County Jail Is the First Jail in the State That’s Also a Licensed
Methadone Treatment Provider, WBUR (Nov. 12, 2019),
C.Agnello SE 0454
Case 2:24-cr-00366-NJC Document 24-1
Filed 03/11/26 Page 458 of 569 PageID #:
652
https://www.wbur.org/commonhealth/2019/11/12/franklin-county-jail-methadone
[https://perma.cc/6UAF-UJSJ].
[89]Id.
[90]Id.
[91]See Traci C. Green, Jennifer Clarke, Lauren Brinkley-Rubinstein, Brandon D. L. Marshall,
Nicole Alexander-Scott, Rebecca Boss & Josiah D. Rich, Research Letter, Postincarceration
Fatal Overdoses After Implementing Medications for Addiction Treatment in a Statewide
Correctional System, 75 JAMA Psychiatry 405, 406 (2018) (finding in preliminary study “a
large and clinically meaningful reduction in postincarceration deaths from overdose among
inmates released from incarceration after implementation of a comprehensive MAT program
in a [Rhode Island] statewide correctional facility—a reduction contributing to overall
population-level declines in overdose deaths”). When this MAT program was introduced, the
proportion of overdose deaths of formerly incarcerated individuals decreased from 14.5% to
5.7% of total overdose deaths. See id.
[92]Naltrexone is similar to methadone and buprenorphine in that it attaches to the brain’s
opioid receptors and blocks other opioid particles, but it is not an opioid itself. See Friedman &
Trent, supra note 32, at 21. Naltrexone is often known by the brand name Vivitrol and is usually
delivered through a monthly injection by a physician. Id.
[93]Performance Budget, supra note 29, at 21 (describing field trial conducted by BOP and
White House Office of National Drug Control Policy).
[94]See id.
[95]Improved Planning, supra note 47, at 29.
[96]Treatment Improvement Protocol, supra note 61, at 30-31.
[97]Federal Guidelines, supra note 55, at 6.
[98]Improved Planning, supra note 47, at 27.
C.Agnello SE 0455
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 459 of 569 PageID #:
653
[99]Id. at 23. In 2019, only forty-one incarcerated individuals in BOP facilities received MAT
through this program. Id. However, only “four inmates received methadone and six inmates
received buprenorphine.” Id. at 23 n.38.
[100]Id. at 31. For example, BOP currently lacks documentation on how it will determine the
number of additional agency personnel needed to support the MAT program expansion; how it
plans to recruit and onboard these personnel; and when BOP will complete the expansion and
meet other relevant time frames and target goals. Id. at 40.
[101]42 U.S.C. §§ 12101-12111 (protecting against disability discrimination by state and local
government).
[102]See Zukle v. Regents of Univ. of Cal., 166 F.3d 1041, 1045 n.11 (9th Cir. 1999) (“There is no
significant difference in analysis of the rights and obligations created by the ADA and the
Rehabilitation Act.”); Armstrong v. Wilson, 124 F.3d 1019, 1023 (9th Cir. 1997) (“Congress has
directed that the ADA and [Rehab Act] be construed consistently.”).
[103]Smith v. Aroostook Cnty., 376 F. Supp. 3d 146, 160 (D. Me. 2019) (granting preliminary
injunction providing buprenorphine as prescribed by plaintiff’s physician during forty-day jail
incarceration), aff’d, 922 F.3d 41 (1st Cir. 2019); Pesce v. Coppinger, 355 F. Supp. 3d 35, 49 (D.
Mass. 2018) (granting preliminary injunction providing methadone as prescribed by plaintiff’s
physician). In at least one case where the judge denied the motion for preliminary injunction on
mootness grounds, the jail subsequently agreed to provide methadone to the plaintiff. See
Sally Friedman & Rebekah Joab, Finnigan v. Mendrick et. al., Legal Action Ctr. (Feb. 2021),
https://www.lac.org/resource/finnigan-v-mendrick [https://perma.cc/4QKF-7B74];
Supplemental Declaration of Nury Marcelo, Finnegan v. Mendrick, No. 1:21-cv-00341 (N.D. Ill.
filed Feb. 26, 2021) (available at https://www.lac.org/assets/files/Dkt-71-D-rpt-to-Ct-
2.26.21.pdf [https://perma.cc/WA6L-G9LF]).
[104]See Corp. Techs., Inc. v. Harnett, 731 F.3d 6, 9 (1st Cir. 2013).
[105]See Smith, 376 F. Supp. 3d at 158-61; Pesce, 355 F. Supp. 3d at 45-47.
[106]Eric Dreiband, Assistant Att’y Gen., U.S. DOJ, Remarks at the National Disability Rights
Network 2019 Annual Conference (June 6, 2019),
https://www.justice.gov/opa/speech/assistant-attorney-general-eric-dreiband-delivered-
C.Agnello SE 0456
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 460 of 569 PageID #:
654
remarks-national-disability-rights [https://perma.cc/R8ZX-3NMY] (stating ADA applies to
individuals taking MAT). In a letter providing guidance to New York State about the ADA’s
application to individuals on MAT, specific examples where the prohibition of MAT could violate
the ADA included “deny[ing] a parent visitation with her child by reason of the
parent’s . . . current use of MAT. . . . Nor could a court impose a blanket rule requiring parents
to stop participating in MAT in order to gain custody of their children.” Letter from Joon H. Kim
to New York State Off. of the Att’y Gen., supra note 61, at 1.
[107]See Press Release, U.S. DOJ, Justice Department Reaches Settlement with Selma
Medical Associates Inc. to Resolve ADA Violations (Jan. 31, 2019) [hereinafter Justice
Department Reaches Settlement with Selma], https://www.justice.gov/opa/pr/justice-
department-reaches-settlement-selma-medical-associates-inc-resolve-ada-violations
[https://perma.cc/JB4C-DE8P] (describing settlement under Title III of ADA against private
medical clinic that refused to accept prospective new patient taking Suboxone); Press Release,
U.S. DOJ, U.S. Attorney’s Office Settles Disability Discrimination Allegations at Skilled Nursing
Facility (May 10, 2018) [hereinafter U.S. Attorney Settles Disability Discrimination Allegations],
https://www.justice.gov/usao-ma/pr/us-attorney-s-office-settles-disability-discrimination-
allegations-skilled-nursing [https://perma.cc/J4A8-297R] (describing settlement under Title
III of ADA against Charlwell House, a skilled nursing facility that refused to accept patient
receiving buprenorphine).
[108]Justice Department Reaches Settlement with Selma, supra note 107; see also U.S.
Attorney Settles Disability Discrimination Allegations, supra note 107.
[109]See Letter from Andrew E. Lelling to David Solet, supra note 70.
[110]Id.
[111]Complaint, Smith v. Fitzpatrick, 2019 WL 1387682 (D. Me. July 26, 2018) (No. 1:18-cv-
00288) (available at https://www.aclumaine.org/sites/default/files/smith_v._fitzpatrick
_complaint.pdf [https://perma.cc/3S7H-XN2H]).
[112]See id. at 1, 2.
[113]See Smith v. Fitzpatrick, et al., ACLU Me. (Sept. 28, 2018),
https://www.aclumaine.org/en/cases/smith–v–fitzpatrick–et–al [https://perma.cc/J9P9-
C.Agnello SE 0457
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 461 of 569 PageID #:
655
ULV2]. A settlement proposal from April 2019 in Kortlever v. Whatcom County provides
another example. See News Release, ACLU Washington, Whatcom County Jail to Provide
Medications Necessary to Treat Opioid Addiction in Landmark Settlement Proposed in Civil
Rights Lawsuit (Apr. 30, 2019), https://www.aclu-wa.org/news/whatcom-county-jail-provide-
medications-necessary-treat-opioid-addiction-landmark-settlement [https://perma.cc
/A56Z-EABR] (discussing proposed class action settlement for nonpregnant individuals with
OUD incarcerated at Whatcom County Jail); see also Complaint, Kortlever v. Whatcom Cnty.,
No. 2:18-cv-00823 (W.D. Wash. filed June 6, 2018) (available at https://www.aclu-
wa.org/docs/complaint-kortlever-et-al-v-whatcom-county).
[114]See ACLU-WA Lawsuit Settled: Federal Prison System Agrees to Provide Medication-
Assisted Treatment for Opioid Use Disorder, ACLU (Dec. 11, 2019),
https://www.aclu.org/press-releases/aclu-wa-lawsuit-settled-federal-prison-system-agrees-
provide-medication-assisted [https://perma.cc/JA5A-SHJB]; Settlement Agreement at 2,
DiPierro v. Hurwitz, No. 1:19-cv-10495 (D. Mass. filed June 7, 2019), available at
https://www.aclum.org/sites/default/files/20190607_dipierro_settlement.pdf; Crews v.
Sawyer, ACLU Kan., https://www.aclukansas.org/en/cases/crews-v-sawyer
[https://perma.cc/93J3-SM6L] (last visited Sept. 1, 2021) (noting parties reached temporary
settlement).
[115]Improved Planning, supra note 47, at 23 n.36.
[116]Performance Budget, supra note 29, at 7.
[117]Brunsden, supra note 79, at 470.
[118]See supra notes 65-70 and accompanying text (describing BOP’s treatment programs for
substance use disorder). However, 77% of formerly incarcerated individuals with OUD relapse
to opioid use within three months of release even if involved with a counseling program, like
BOP’s, while incarcerated. See Substance Abuse & Mental Health Servs. Admin., Medication-
Assisted Treatment (MAT) in the Criminal Justice System: Brief Guidance to the States 1
(2019).
[119]See infra notes 126-34 and accompanying text.
C.Agnello SE 0458
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 462 of 569 PageID #:
656
[120]Painful withdrawal symptoms may impair an incarcerated individual’s capacity to make
informed legal decisions or calculate the risk of sharing needles. See Bruce & Schleifer, supra
note 40, at 19. These withdrawals also create unnecessary suffering, a potential interruption of
life-sustaining medical treatments for other conditions, an exacerbation or masking of other
medical conditions, and sometimes death. See Substance Use Disorder Treatment for Adults
and Adolescents, supra note 58. See generally Curtis Bone, Lindsay Eysenbach, Kristen Bell &
Declan T. Barry, Our Ethical Obligation to Treat Opioid Use Disorder in Prisons: A Patient and
Physician’s Perspective, 46 J.L. Med. & Ethics 268 (2018) (arguing that failure to bring
treatment into criminal justice systems will result in otherwise preventable disease and death
among incarcerated people). MAT would reduce some of these external harms, including the
risk of infectious diseases. See Substance Use Disorder Treatment for Adults and Adolescents,
supra note 58 (noting effective substance treatment in correctional facilities, including long-
term MAT, reduces spread of blood-borne infections through needle sharing).
[121]See supra note 26 and accompanying text (discussing how opioid epidemic affects all
racial groups); see also Friedmann et al., supra note 82, at 10 (“[S]tate budget crises provide
impetus for evidence-based interventions such as MAT to reduce the costs of rearrests and
reincarceration as well as the societal, human, and health care costs associated with chronic
substance dependence.”); Wakeman & Rich, supra note 29, at 220 (estimating cost of
untreated alcohol and illicit drug use on health care, productivity, crime, incarceration, and
drug enforcement is $366 billion per year).
[122]See supra note 9-11 and accompanying text (discussing healthcare and other systemic
inequities in context of COVID-19 pandemic); supra note 52 and accompanying text
(discussing rates of mass incarceration for drug offenses by race); James & Jordan, supra note
23, at 413 (recognizing that lack of access to treatment for substance use disorder is more
pronounced in minority communities than in general population).
[123]See Brunsden, supra note 79, at 470 (“[M]edical care and public health interventions for
prisoners are considered tantamount to better health outcomes for the general
population . . . .”); Wallace & Wang, supra note 38, at 10-11 (“[T]he link between incarceration
and health, and now recidivism, suggests that if we are to lower the high rates of recidivism, we
can no longer ignore the health of justice-involved individuals, whether these individuals are
incarcerated or have been released.”); see also infra notes 126-34 and accompanying text
(discussing how providing MAT would reduce rates of recidivism and overdose deaths).
C.Agnello SE 0459
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 463 of 569 PageID #:
657
[124]Nat’l Comm’n on Aids, HIV Disease in Correctional Facilities 36 (1991) (discussing need
to respond to HIV in prisons); see also Brunsden, supra note 79, at 470 (“If left unidentified,
untreated, and uneducated about the disease, HCV-infected inmates reentering society
present a transmission risk to the community and are less likely to achieve successful
reintegration.”).
[125]See supra notes 48-51 and accompanying text (discussing disproportionate
representation of substance use disorder amongst incarcerated population). See generally
Burris, supra note 81 (arguing public health crises, like HIV and substance use disorder, can be
addressed through critical medical treatment provided behind bars).
[126]See Durose & Mumola, supra note 49, at 4 (showing within 3 years of release from state
prison, about 69.1% of nonviolent releasees were rearrested for new crime, 48.4% were
reconvicted, and 26.7% returned to prison).
[127]See supra notes 48-51 and accompanying text.
[128]Smith v. Aroostook Cnty., 376 F. Supp. 3d 146, 150 (D. Me. 2019), aff’d, 922 F.3d 41 (1st
Cir. 2019) (describing plaintiff’s withdrawal from Suboxone while incarcerated in jail as “the
worst pain she has ever endured” and leading to “suicidal thoughts for the first time in her
life”); Jeronimo A. Maradiaga, Shadi Nahvi, Chinazo O. Cunningham, Jennifer Sanchez, Aaron
D. Fox, “I Kicked the Hard Way. I Got Incarcerated.” Withdrawal from Methadone During
Incarceration and Subsequent Aversion to Medication Assisted Treatments, 62 J. Substance
Abuse Treatment 49, 52 (2016) (noting that severe withdrawal symptoms when MAT is
abruptly stopped lead to incarcerated individual’s reluctance to obtain future MAT).
[129]See Wallace & Wang, supra note 38, at 7 (finding prisoners with good mental health while
incarcerated had lowest rates of recidivism); Verner S. Westerberg, Barbara S. McCrady,
Mandy Owens & Paul Guerin, Community-Based Methadone Maintenance in a Large Detention
Center Is Associated with Decreases in Inmate Recidivism, 70 J. Substance Abuse Treatment 1,
4-5 (2016) (finding inmates in jail-based methadone treatment program exhibited significantly
longer time until rearrest compared with control groups, including those detoxified in jail).
Public health experts felt similar outrage about Hepatitis C, which is often directly linked to
substance use, because “[i]f left unidentified, untreated, and uneducated about the disease,
HCV-infected inmates reentering society . . . are less likely to achieve successful reintegration.”
C.Agnello SE 0460
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 464 of 569 PageID #:
658
Brunsden, supra note 79, at 470. For an argument that prisons should become centers of
public health works, and prisoners’ rights advocates should partner with health agencies—
both public and voluntary—to coordinate efforts to meet patients’ needs within correctional
facilities, see Burris, supra note 81 (recognizing framework for coordinated approach applies
to both communicable diseases and drug use treatment within correctional facilities).
[130]See Friedman & Trent, supra note 32, at 20.
[131]See Ingrid A. Binswanger, Marc F. Stern, Richard A. Deyo, Patrick J. Heagerty, Allen
Cheadle, Joann G. Elmore & Thomas D. Koepsell, Release from Prison—A High Risk of Death for
Former Inmates, 356 New Eng. J. Med. 157, 157 (2007) (noting that individuals in Washington
are 129 times more likely to die than general population); Becker, supra note 88 (noting
individuals in Massachusetts are 120 times more likely to die than general population).
[132]See Final Report, supra note 58, at 72 (citing John Marsden, Garry Stillwell, Hayley Jones,
Alisha Cooper, Brian Eastwood, Michael Farrell, Tim Lowden, Nino Maddalena, Chris Metcalfe,
Jenny Shaw & Matthew Hickman, Does Exposure to Opioid Substitution Treatment in Prison
Reduce the Risk of Death After Release? A National Prospective Observational Study in England,
112 Addiction 1408, 1415 (2017) (finding individuals receiving MAT in prison were 85% less
likely to die of drug poisoning in first month after release)).
[133]See Josiah D. Rich, Michelle McKenzie, Sarah Larney, John B. Wong, Liem Tran, Jennifer
Clarke, Amanda Noska, Manasa Reddy & Nickolas Zaller, Methadone Continuation Versus
Forced Withdrawal on Incarceration in a Combined US Prison and Jail: A Randomised, Open-
Label Trial, 386 Lancet 350, 355-56 (2015) (finding group of prisoners who continued
methadone treatment during incarceration had lower rates of drug use and fewer overdoses
than prisoners whose methadone treatment discontinued during incarceration).
[134]See supra Part I.B.3.
[135]29 U.S.C. § 794(a).
[136]Id.
[137]Cash v. Smith, 231 F.3d 1301, 1305 n.2 (11th Cir. 2000); see also Kiman v. N.H. Dep’t of
Corr., 451 F.3d 274, 285 n.10 (1st Cir. 2006).
C.Agnello SE 0461
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 465 of 569 PageID #:
659
[138]See Zukle v. Regents of Univ. of Cal., 166 F.3d 1041, 1045 n.11 (9th Cir. 1999) (“There is no
significant difference in analysis of the rights and obligations created by the ADA and the
Rehabilitation Act.”); Armstrong v. Wilson, 124 F.3d 1019, 1023 (9th Cir. 1997) (“Congress has
directed that the ADA and [Rehab Act] be construed consistently.”).
[139]Elizabeth O’Connor Tomlinson, 152 Am. Jur. Trials, Litigation of Prisoners’ Access to
Medical Care § 9, Westlaw (database updated 2021) (noting courts consider claims made
under both statutes identically, unless “subtle distinctions” are pertinent to case).
[140]28 C.F.R. § 39.103 (2021); see also 29 U.S.C. § 705(9)(B) (defining disability under Rehab
Act by “the meaning given it in [the ADA]”). The determination about whether an impairment
substantially limits a major life activity is made without regard to the effect of medication or
other ameliorating measures. See 42 U.S.C. § 12102(4)(E)(i).
[141]29 U.S.C. § 705(20)(C)(i).
[142]Id. § 705(20)(C)(ii) (noting individuals not excluded who use drugs under supervision by
licensed health care professional or for other uses authorized by law).
[143]See id. § 705(20)(C)(iii).
[144]Se. Cmty. Coll. v. Davis, 442 U.S. 397, 406 (1979).
[145]28 C.F.R. § 39.103.
[146]See Pierce v. Cnty. of Orange, 526 F.3d 1190, 1214 (9th Cir. 2008).
[147]See Pa. Dep’t of Corr. v. Yeskey, 524 U.S. 206, 210 (1998) (“Modern prisons provide
inmates with . . . medical ‘services,’ . . . which at least theoretically ‘benefit’ the prisoners (and
any of which disabled prisoners could be ‘excluded from participation in’).” (quoting 42 U.S.C.
§ 12132)); see also Clark v. California, 739 F. Supp. 2d 1168, 1230 (N.D. Cal. 2010) (“Daily living
activities, including . . . the receipt of medication, constitute ‘services, programs, or activities’
under the ADA and [Rehab Act].”).
[148]See Bilal v. N.Y. City Dep’t of Corr., No. 08-cv-06664, 2010 WL 1875731, at *5 (S.D.N.Y.
May 10, 2010) (comparing First Circuit’s approach to Seventh and Tenth Circuits’ approach on
C.Agnello SE 0462
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 466 of 569 PageID #:
660
this issue, and noting that “[t]here appears to be a split in authority on this question”).
[149]See, e.g., Grzan v. Charter Hosp. of Nw. Ind., 104 F.3d 116, 120 (7th Cir. 1997) (“An
otherwise qualified person is one who is able to meet all of a program’s requirements in spite
of [her] handicap.” (quoting Se. Cmty. Coll. v. Davis, 442 U.S. 397, 406 (1979))); Johnson v.
Thompson, 971 F.2d 1487, 1493-94 (10th Cir. 1992) (finding no Rehab Act claim where plaintiff
“would not need the medical treatment” in absence of disability); United States v. Univ. Hosp.,
729 F.2d 144, 156 (2d Cir. 1984) (“[S]ection 504 prohibits discrimination against a
handicapped individual only where the individual’s handicap is unrelated to, and thus improper
to consideration of, the services in question . . . [W]here medical treatment is at issue, it is
typically the handicap itself that gives rise to, or at least contributes to, the need for
services.”).
[150]See Olmstead v. L.C., 527 U.S. 581, 598 n.10 (1999) (stating plaintiff can demonstrate
disability discrimination under ADA through comparison to other members of protected class
or non-handicapped individuals); e.g., Grzan, 104 F.3d at 121-22 (“We agree with Johnson and
University Hospital that section 504 is ill suited for bringing claims of discriminatory medical
treatment against a facility when the plaintiff is comparing her treatment (medical or non-
medical) to the treatment afforded other handicapped individuals.”).
[151]546 U.S. 151, 151 (2006).
[152]See id. at 153-55.
[153]Id. at 157.
[154]See id. at 159-60 (remanding for plaintiff to amend complaint and create more
substantial factual record to determine whether State violated ADA).
[155]Id. at 159; see id. at 161 (Stevens, J., concurring) (“[T]he history of mistreatment leading
to Congress’ decision to extend Title II’s protections to prison inmates was not limited to
violations of the Eighth Amendment.”). For an argument that the failure to provide MAT
violates inmates’ Eighth Amendment rights, see Linden et al., supra note 40.
[156]See Georgia, 546 U.S. at 157.
C.Agnello SE 0463
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 467 of 569 PageID #:
661
[157]451 F.3d 274 (1st Cir. 2006).
[158]See id. at 284 (citing Georgia, 546 U.S. at 157).
[159]See id. at 276.
[160]Id. at 286-87.
[161]However, the circuit split has not been affirmatively resolved and deserves more attention
beyond the scope of this Note. Although it has been recognized that Olmstead v. L.C., 527 U.S.
581 (1999), abrogates Grzan v. Charter Hospital of Northwestern Indiana, 104 F.3d 116 (7th Cir.
1997), see Amundson v. Wis. Dep’t of Health Servs., 721 F.3d 871, 874 (7th Cir. 2013)
(“Olmstead indeed supersedes Grzan . . . .”), the other cited cases remain good law.
[162]See Kiman, 451 F.3d at 286-87; see also Lonergan v. Fla. Dep’t of Corr., 623 F. App’x 990,
994 (11th Cir. 2015) (finding plaintiff pled prima facie ADA discrimination claim based on
“failure of the prison to give the Plaintiff the treatment prescribed by his dermatologist”);
McKissick v. Cnty. of York, No. 1:09-cv-01840, 2010 WL 1930132, at *7 (M.D. Pa. Mar. 19,
2010), report and recommendation adopted, No. 1:09-cv-01840, 2010 WL 1930144 (M.D. Pa.
May 13, 2010) (finding plaintiff pled facts sufficient to survive motion to dismiss where plaintiff
alleged corrections officers and prison medical officials denied access to his prescribed
methadone for OUD, “which disrupted his ability to derive benefit from other life-preserving
treatment” for other medical conditions).
[163]28 C.F.R. § 39.130 (2021) (listing DOJ’s prohibited practices, including “[d]eny[ing] a
qualified handicapped person the opportunity to participate in or benefit from the aid, benefit,
or service”); see, e.g., Pierce v. Cnty. of Orange, 526 F.3d 1190, 1221 (9th Cir. 2008) (“[A]n
inmate cannot be categorically excluded from a beneficial prison program based on his or her
disability alone.”).
[164]See Fulton v. Goord, 591 F.3d 37, 43 (2d Cir. 2009).
[165]See Kiman, 451 F.3d at 283 (stating ADA’s reasonable accommodation rule requires that
either plaintiff make request for accommodation or that their need for accommodation is
obvious).
C.Agnello SE 0464
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 468 of 569 PageID #:
662
[166]Alexander v. Choate, 469 U.S. 287, 301 (1985) (“The benefit itself, of course, cannot be
defined in a way that effectively denies otherwise qualified handicapped individuals the
meaningful access to which they are entitled; to assure meaningful access, reasonable
accommodations in the grantee’s program or benefit may have to be made.”).
[167]Smith v. Aroostook Cnty., 376 F. Supp. 3d 146, 160 (D. Me. 2019) (noting Suboxone was
only form of treatment effective at managing plaintiff’s OUD, and failure to accommodate
Suboxone use therefore denies plaintiff meaningful access to medical services), aff’d, 922 F.3d
41 (1st Cir. 2019); see also Mitchell v. Williams, No. 6:15-cv-00093, 2016 WL 723038, at *4
(S.D. Ga. Feb. 22, 2016) (finding plaintiff’s complaint under ADA not frivolous where plaintiff
was denied medical treatment for Hepatitis C because of high costs, whereas inmates with
less costly conditions received treatment).
[168]See Lonergan v. Fla. Dep’t of Corr., 623 F. App’x 990, 994 (11th Cir. 2015) (recognizing
plaintiff’s claim based on failure to provide dermatologist-prescribed treatment constituted
“more than the mere disagreement with his medical treatment” and was thus sufficient under
ADA).
[169]Kiman, 451 F.3d at 287; see also McKissick v. Cnty. of York, No. 1:09-cv-01840, 2010 WL
1930132, at *7 (M.D. Pa. Mar. 19, 2010), report and recommendation adopted, No. 1:09-cv-
01840, 2010 WL 1930144, at *1 (M.D. Pa. May 13, 2010) (finding plaintiff’s allegations survived
motion to dismiss where prison officials denied access to prescribed methadone to treat OUD
and Kayexalate to treat rising potassium levels).
[170]Kiman, 451 F.3d at 285 (quoting Lesley v. Chie, 250 F.3d 47, 55 (1st Cir. 2001)).
[171]355 F. Supp. 3d 35 (D. Mass. 2018).
[172]See id. at 47.
[173]See id. at 40-41.
[174]See id. at 41.
[175]See id. at 45 (“Defendants, in lieu of conducting an individualized assessment of Pesce’s
medical needs or his physician’s recommendation, would require Pesce to participate in a
C.Agnello SE 0465
Case 2:24-cr-00366-NJC Document 24-1Filed 03/11/26 Page 469 of 569 PageID #:
663
treatment program that bares strong resemblance to the methods that failed Pesce for five
years . . . .”).
[176]See id. at 46 (distinguishing from Kiman, where there was individualized assessment of
plaintiff’s medical needs, to reach different conclusion).
[177]Kiman v. N.H. Dep’t of Corr., 451 F.3d 274, 285 (1st Cir. 2006).
[178]28 C.F.R. § 39.150(a)(2) (2020); see Se. Cmty. Coll. v. Davis, 442 U.S. 397, 410 (1979)
(finding plaintiff’s requested accommodations for full-time supervision during patient visits
and elimination of all clinical programs constituted fundamental alteration in nature of nursing
program).
[179]442 U.S. 397 (1979).
[180]Id.
[181]Id. at 400, 402.
[182]Id. at 409.
[183]Id.
[184]Id. at 410.
[185]For example, in Harris v. Thigpen, 941 F.2d 1495 (11th Cir. 1991), the plaintiff challenged a
prison policy segregating HIV–positive prisoners from the general incarcerated population.
The court found “the prison’s choice of blanket segregation should [not] alone insulate the
[Alabama Department of Corrections] from its affirmative obligation under the [ADA] to
pursue and implement such alternative, reasonable accommodations as are possible for HIV-
positive prisoners.” Id. at 1527 (footnote omitted).
[186]Alexander v. Choate, 469 U.S. 287, 300 (1985).
[187]28 C.F.R. § 39.150(a)(2) (2021); see Alexander, 469 U.S. at 308 (recognizing
administrative costs associated with eliminating durational limitations on inpatient Medicaid
C.Agnello SE 0466
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 470 of 569 PageID #:
664
coverage “would be far from minimal” and are “well beyond the accommodations that are
required”).
[188]See Disabled in Action v. Bd. of Elections in N.Y., 752 F.3d 189, 204 (2d Cir. 2014)
(“Without more than conclusory claims that complying with the remedial order may be
challenging, we are not persuaded that the accommodations will fundamentally alter [the
Board of Elections’] voting program or impose an undue burden on its operation.”).
[189]Sch. Bd. of Nassau Cnty. v. Arline, 480 U.S. 273, 289 (1987) (stating school teacher fired
for susceptibility to Tuberculosis would not be “otherwise qualified” for activity under Rehab
Act if they pose direct threat to others); see also 29 U.S.C. § 705(20)(D) (excluding individuals
who constitute “direct threat to the health or safety of other individuals” by reason of
contagious disease or infection from Rehab Act’s coverage in employment context). The Arline
Court articulated “basic factors” to determine whether the carrier of a contagious disease
posed a direct threat:
[Findings of] facts, based on reasonable medical judgments given the state of medical
knowledge, about (a) the nature of the risk (how the disease is transmitted), (b) the duration of
the risk (how long is the carrier infectious), (c) the severity of the risk (what is the potential
harm to third parties) and (d) the probabilities the disease will be transmitted and will cause
varying degrees of harm.
Arline, 480 U.S. at 288 (quoting Brief of the Am. Med. Ass’n as Amicus Curiae in Support of
Petitioners at 19, Arline, 480 U.S. 273 (No. 85-1277), 1985 WL 669434, at *19).
[190]See id. at 287 (noting that individualized “inquiry is essential if [the Rehab Act] is to
achieve its goal of protecting [individuals with disabilities] from deprivations based on
prejudice, stereotypes, or unfounded fear.”); see also Bragdon v. Abbott, 524 U.S. 624, 649
(1998) (“[P]etitioner had the duty to assess the risk of infection based on the objective,
scientific information available to him and others in his profession. His belief that a significant
risk existed, even if maintained in good faith, would not relieve him from liability.”); Samuel R.
Bagenstos, The Americans with Disabilities Act as Risk Regulation, 101 Colum. L. Rev. 1479,
1490 (2001) (positing “direct threat” doctrine arose in response to “tension between the
imperative of public safety and the obligation to eliminate unfounded stereotypes [that] arises
repeatedly in disability rights law”).
C.Agnello SE 0467
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 471 of 569 PageID #:
665
[191]Havens v. Colo. Dep’t of Corr., 897 F.3d 1250, 1269 n.11 (10th Cir. 2018).
[192]See Inmates of Allegheny Cnty. Jail v. Pierce, 612 F.2d 754, 761 (3d Cir. 1979) (recognizing
jail’s apparent security concerns about drug use within facility because “[t]he potential for jail
or prison disruption caused by the presence of drugs is well-known”); Felice J. Freyer, State
Crime Bills Would Expand Inmates’ Access to Addiction Treatment, Bos. Globe (Nov. 20, 2017,
6:59 PM), https://www.bostonglobe.com/metro/2017/11/20/state-crime-bills-would-
expand-inmates-access-addiction-treatment/7TI2SCOz5FNEZgmrEnIl2O/story.html%3e
(describing concerns for MAT-recipient’s well-being). Christopher Mitchell, assistant deputy
commissioner of reentry for the Massachusetts Department of Correction, noted the value of
buprenorphine and, consequentially, “it’s causing people to be assaulted. It’s causing people
to have hits put on them. . . . People have to go into protective custody because of debts
they’ve acquired. In a prison environment, whatever the contraband is, it’s life and death.” Id.
[193]Turner v. Safley, 482 U.S. 78, 89 (1987); see also Casey v. Lewis, 4 F.3d 1516, 1521 (9th
Cir. 1993) (finding prohibition against HIV-positive inmates having contact visitation with
attorneys was reasonably related to legitimate penological interests).
[194]482 U.S. 78 (1987).
[195]Id. at 79, 98.
[196]See id. at 91.
[197]See id. at 92-93 (noting prison officials’ decision “should not be lightly set aside by the
courts” when “exercise of a right requires this kind of tradeoff” between rights and security).
[198]Compare Onishea v. Hopper, 171 F.3d 1289, 1300 (11th Cir. 1999) (en banc) (“Turner does
not, by its terms, apply to statutory rights.”), with Gates v. Rowland, 39 F.3d 1439, 1447 (9th
Cir. 1994) (finding Turner “equally applicable to the statutory rights created by the [ADA]” in
the prison context).
[199]Havens v. Colo. Dep’t of Corr., 897 F.3d 1250, 1269 n.11 (10th Cir. 2018) (“[W]e believe
that—at the very least—it is appropriate and prudent to take these variables into account in
attempting to discern under [the Rehab Act] whether a prisoner’s access to prison services
C.Agnello SE 0468
Case 2:24-cr-00366-NJC Document 24-1
Filed 03/11/26 Page 472 of 569 PageID #:
666
and programs was meaningful and whether the prison reasonably accommodated the
prisoner’s disability.”).
[200]Onishea, 171 F.3d at 1300.
[201]Castle v. Eurofresh, Inc., 731 F.3d 901, 911 (9th Cir. 2013).
[202]See Pesce v. Coppinger, 355 F. Supp. 3d 35, 46 (D. Mass. 2018) (finding defendants only
“identified legitimate, but generalized, safety and security reasons for prohibiting the use of
opioids in their facilities,” but did not identify “specific security concerns relevant to Pesce’s
proposed methadone intake”).
[203]Letter from Joon H. Kim to New York State Off. of the Att’y Gen., supra note 61, at 1.
[204]Pesce, 355 F. Supp. 3d at 47 (quoting Kiman v. N.H. Dep’t of Corr., 451 F.3d 274, 284 (1st
Cir. 2006)).
[205]29 U.S.C. § 794(a) (“The head of each such agency shall promulgate such regulations as
may be necessary . . . .”); see also 28 C.F.R. § 39.102 (2021) (applying Rehab Act to DOJ).
[206]Improved Planning, supra note 47, at 9.
[207]Id. at 23 n.38 (“In fiscal year 2019, four inmates received methadone and six inmates
received buprenorphine.”).
[208]Id. at 23.
[209]See 28 C.F.R. § 36.105(b)(2) (2021) (defining physical or mental impairment to include
“drug addiction”); Letter from Andrew E. Lelling to David Solet, supra note 70 (“Individuals in
treatment for OUD [requiring MAT prior to confinement] are protected by the ADA.”). OUD
substantially limits several major life activities, including everyday activities and biological
functions. See 42 U.S.C. § 12102(2)(A) (caring for oneself, learning, concentrating, thinking,
communicating); id. § 12102(B) (operation of neurological and brain functions); see also id.
§ 12102(4)(D) (“An impairment that is . . . in remission is a disability if it would substantially
limit a major life activity when active.”).
C.Agnello SE 0469
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 473 of 569 PageID #:
667
[210]See Pesce v. Coppinger, 355 F. Supp. 3d 35, 45 (D. Mass. 2018) (recognizing parties did
not dispute that plaintiff with OUD is “qualified individual[] with disabilities” under ADA
(alteration in original)); U.S. Attorney Settles Disability Discrimination Allegation, supra note
107 (“Individuals receiving treatment for OUD are generally considered disabled under the
ADA . . . .”).
[211]29 U.S.C. § 705(20)(F)(iii).
[212]See supra notes 141-42 and accompanying text.
[213]29 U.S.C. § 705(20)(C)(i) (emphasis added); cf. A.B. ex rel. Kehoe v. Hous. Auth. of S.
Bend, No. 3:11-cv-00163, 2012 WL 1877740, at *5 (N.D. Ind. May 18, 2012) (finding that tenant
“was not disabled at the time [the housing authority] sent the eviction notice” because
eviction notice was sent because of tenant’s cocaine use).
[214]See, e.g., Mauerhan v. Wagner Corp., 649 F.3d 1180, 1188-89 (10th Cir. 2011) (finding one
month of abstention insufficient); Brown v. Lucky Stores, Inc., 246 F.3d 1182, 1186 (9th Cir.
2001) (requiring abstention from drugs for “a significant period of time”); United States v. S.
Mgmt. Corp., 955 F.2d 914, 919 (4th Cir. 1992) (finding one year of abstention sufficient).
[215]29 U.S.C. § 705(20)(C)(ii)(I).
[216]See Kehoe, 2012 WL 1877740, at *4 (“The point is that it is perfectly permissible for an
entity—an employer, a public housing authority etc.—to take an adverse action against
someone who is caught using drugs. But what an entity cannot do is discriminate against
someone for past drug use or for their efforts at drug rehabilitation.” (second emphasis
added)).
[217]29 U.S.C. § 705(20)(C)(iii).
[218] The ADA does say someone currently using drugs illegally is not considered an
“individual with a disability”—that term generally applies to a person in recovery—but the law
also says that even current users cannot be denied health care. But much of how the ADA
applies in these situations is open to interpretation and has not been tested in the courts.
C.Agnello SE 0470
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 474 of 569 PageID #:
668
Beth Schwartzapfel, How the Americans with Disabilities Act Could Change the Way the
Nation’s Jails and Prisons Treat Addiction, ABA J. (Feb. 8, 2019, 6:30 AM),
https://www.abajournal.com/news/article/how_the_ada_could_change_jails_prisons_addiction_
[https://perma.cc/GM37-CDN8].
[219]See Pa. Dep’t of Corr. v. Yeskey, 524 U.S. 206, 210 (1998); Kiman v. N.H. Dep’t of Corr.,
451 F.3d 274, 286-87 (1st Cir. 2006).
[220]See supra notes 148-49 and accompanying text.
[221]See supra notes 157-62 and accompanying text.
[222]See Kiman, 451 F.3d at 286-87. But see George v. Cnty. of Jefferson, No. 2:10-cv-03389,
2013 WL 5519509, at *10 (N.D. Ala. Sept. 30, 2013) (distinguishing from Kiman where plaintiff
“received medications during his incarceration and medication services while on detoxification
regimen”).
[223]See Smith v. Aroostook Cnty., 376 F. Supp. 3d 146, 160 (D. Me. 2019), aff’d, 922 F.3d 41
(1st Cir. 2019). The increasing body of scientific evidence that MAT is an effective treatment
method renders this a relevant concern for individuals who have not previously been
prescribed MAT, as well.
[224]See Freyer, supra note 192 (describing statement by Maryanne Frangules, executive
director of advocacy group Massachusetts Organization for Addiction Recovery: “You wouldn’t
stop insulin if somebody had diabetes”).
[225]Becker, supra note 88 (quoting statements by Franklin County Sheriff Christopher J.
Donelan). Franklin County Jail was the first jail in Massachusetts to provide buprenorphine as a
treatment method for OUD. See id.
[226]Smith, 376 F. Supp. 3d at 160.
[227]See Improved Planning, supra note 47, at 6 (describing Psychology Services Intake
Questionnaire to determine incarcerated individuals’ “potential drug treatment and mental
health needs”).
C.Agnello SE 0471
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 475 of 569 PageID #:
669
[228]See Patient Care, supra note 72, at 24-25.
[229]See supra notes 70-76 and accompanying text.
[230]See Smith, 376 F. Supp. 3d at 160.
[231]See Kiman v. N.H. Dep’t of Corr., 451 F.3d 274, 287 (1st Cir. 2006).
[232]See Pesce v. Coppinger, 355 F. Supp. 3d 35, 45 (D. Mass. 2018).
[233]See, e.g., id. (remarking that plaintiff’s doctor “explained that Pesce risks severe physical
and mental illness, relapse into opioid addiction and death if he is denied access to methadone
and subjected to Defendants’ treatment program”).
[234]See Kiman, 451 F.3d at 284-85 (“[A] plaintiff may argue that her physician’s decision was
discriminatory on its face, because it rested on stereotypes of the disabled . . . .” (quoting
Lesley v. Chie, 250 F.3d 47, 55 (1st Cir. 2001)).
[235]See Smith, 376 F. Supp. 3d. at 159-60.
[236]See id. (“The Defendants’ out-of-hand, unjustified denial of the Plaintiff’s request for her
prescribed, necessary medication—and the general practice that precipitated that denial—is
so unreasonable as to raise an inference that the Defendants denied the Plaintiff’s request
because of her disability.”).
[237]Friedmann et al., supra note 82, at 12. Preference for drug-free treatment varies by
agency type; prisons tended to cite a preference for drug-free treatment as a greater factor in
their decisions to use MAT than drug courts, jails, and probation or parole agencies. See id.
[238]See Smith, 376 F. Supp. 3d at 161 n.19 (“All that is before me is the request to ensure
MAT access for Ms. Smith, an individual who has successfully managed her opioid use disorder
with MAT for the last decade.”). For example, the individualized inquiry will look different for an
incarcerated individual who was on MAT for ten years, compared to someone who started two
weeks prior to incarceration, or for someone who was previously prescribed MAT, compared to
someone who would be introduced to MAT in prison.
C.Agnello SE 0472
Case 2:24-cr-00366-NJC Document 24-1
Filed 03/11/26 Page 476 of 569 PageID #:
670
[239]See supra notes 116-17 and accompanying text; see also Letter from William P. Barr, Att’y
Gen., Off. of Att’y Gen., in U.S. DOJ, The First Step Act of 2018: Risk and Needs Assessment
System iv, v (July 19, 2019), https://www.bop.gov/inmates/fsa/docs/the-first-step-act-of-
2018-risk-and-needs-assessment-system.pdf [https://perma.cc/6H93-KWJP] (“Our
communities are safer when we do a better job of rehabilitating offenders in [DOJ] custody and
preparing them for a successful transition to life after incarceration. The [DOJ] remains
committed to this important aim and will continue to work to make America’s communities
safer.”).
[240]See Emanuel Krebs, Darren Urada, Elizabeth Evans, David Huang, Yih-Ing Hser & Bohdan
Nosyk, The Costs of Crime During and After Publicly Funded Treatment for Opioid Use
Disorders: A Population-Level Study for the State of California, 112 Addiction 838, 846 (2016)
(finding that methadone or buprenorphine treatment for individuals involved in criminal justice
system saved nearly $18,000 per person over six months, compared to detoxification alone).
BOP estimates that its new MAT program “costs about $500 per month for an inmate to
receive medication, therapy, and urinalysis screening at an opioid treatment program.”
Improved Planning, supra note 47, at 24. BOP officials also estimate needing $76.2 million
across fiscal years 2020 and 2021. See id. at 27. For a comparison, between fiscal years 2015
through 2019, BOP spent an average of $116.9 million per year on its other drug education and
treatment programs. Id. at 24.
[241]See Bone et al., supra note 120, at 269 (stating that agonist therapy returns $12-14 for
every $1 spent); Rebecca Boucher, Note, The Case for Methadone Maintenance Treatment in
Prisons, 27 Vt. L. Rev. 453, 458 (2003) (noting in 2003, methadone treatment cost about
$4,000 per person each year, whereas prison incarceration on average cost $22,279 each
year).
[242]See Brady P. Horn, Xiaoxue Li, Saleh Mamun, Barbara McCrady & Michael T. French, The
Economic Costs of Jail-Based Methadone Maintenance Treatment, 44 Am. J. Drug & Alcohol
Abuse 611, 614 (2018) (studying methadone program in 39th largest jail in U.S., where weekly
economic cost per client of methadone treatment was $115). Although BOP facilities would
likely have a smaller per–patient cost, this reduction would be offset by the longer
incarcerations in federal facilities.
C.Agnello SE 0473
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 477 of 569 PageID #:
671
[243]BOP is supposedly pursuing certification to provide MAT in its facilities. See Improved
Planning, supra note 47, at 30 n.50.
[244]See Letter from William P. Barr, supra note 239 (“I directed that existing resources [in
BOP] be reallocated in FY2019 to . . . increase the availability of Medication Assisted
Treatment . . . .”); see also CREATE Opportunities Act, S. 1983, 116th Cong. § 2(c) (2019)
(proposing federal grants to: (1) develop MAT programs, (2) reduce the risk of overdose to
participants after release from incarceration, and (3) reduce rate of reincarceration). BOP
“plan[s] to use $37.1 million in appropriated funds that BOP received to implement the First
Step Act of 2018 (First Step Act) on MAT program expansion efforts during fiscal year 2020.”
See Improved Planning, supra note 47, at 27-28.
[245]See Bruce & Schleifer, supra note 40, at 18.
[246]392 F. Supp. 305 (N.D. Ohio 1974).
[247]Id. at 312 (reasoning that there are other ways for jail to ensure safety besides just
prohibiting methadone).
[248]376 F. Supp. 3d 146 (D. Me. 2019), aff’d, 922 F.3d 41 (1st Cir. 2019).
[249]Id. at 160-61; see also Pesce v. Coppinger, 355 F. Supp. 3d 35, 46 (D. Mass. 2018)
(“Defendants have not explained why they cannot safely and securely administer prescription
methadone in liquid form to Pesce under the supervision of medical staff, especially given that
this is a common practice in institutions across the United States and in two facilities in
Massachusetts.”). In fact, one study found that 70% of surveyed sites that did not currently
provide MAT indicated it would be possible to introduce methadone and buprenorphine if there
were available evidence that MAT improved criminal justice outcomes, and 63% of sites that
already provided MAT said they would consider expanding their methadone, buprenorphine, or
naltrexone programs if they had such evidence. See Friedmann et al., supra note 82, at 14.
These statistics demonstrate that implementing a MAT program is feasible and that the real
hostility towards a MAT program likely stems from misperceptions about MAT.
[250]See notes 85-91 and accompanying text. “‘The process we do [in Franklin County Jail],
it’s almost impossible [to divert MAT],’ [one inmate] says. ‘There’s no way. I mean if you
attempt it you’re just dumb.’” Becker, supra note 88. Although this example comes from a
C.Agnello SE 0474
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 478 of 569 PageID #:
672
state jail, it indicates that initial assumptions about the risk of diversion and other safety
concerns are not always accurate.
[251]See Pharmacy Services, supra note 71, at 39.
[252]See Bruce & Schleifer, supra note 40, at 20 (stating that correctional settings should be
the easiest in which to implement methadone treatment “[b]ecause correctional systems are
already well designed to offer the security surrounding storage of opioids, such as methadone,
and the supervision regarding dosing”).
[253]For example, the risk of diversion and safety concerns vary based on the type of
correctional facility, type of MAT at issue, and specific makeup of the prison population. BOP
operates prisons at four levels of security, and they vary in size and other factors. See U.S.
Performance Budget, supra note 29, at 4. Accordingly, each level and prison poses its own
unique circumstances to consider when making reasonable accommodations.
[254]See notes 41, 70, 106-08 and accompanying text.
[255]Justice Department Reaches Settlement with Selma, supra note 107 (quoting Assistant
Attorney General Eric Dreiband).
[256]Id.
[257]Improved Planning, supra note 47, at 30 n.50.
[258]See Nat’l Comm’n on Corr. Health Care, supra note 58 (listing various means for
correctional facilities to provide incarcerated individuals with access to MAT). BOP facilities
that provide MAT to pregnant incarcerated individuals or to detoxing individuals likely adhere
to various registration requirements already.
[259]Netherland & Hansen, supra note 26, at 680 (recognizing need for advocates to address
institutional racism embedded in media coverage of opioid epidemic in order to dismantle
racial exclusions in drug interventions).
[260]For arguments that policymakers must provide culturally competent support to address
the opioid epidemic, see James & Jordan, supra note 23, at 404, which recognizes the need for
C.Agnello SE 0475
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 479 of 569 PageID #:
673
“culturally targeted programs to benefit Black communities in the opioid crisis. Such programs
include the use of faith-based organizations to deliver substance use prevention and treatment
services, the inclusion of racial impact assessments in the implementation of drug policy
proposals, and the formal consideration of Black people’s interaction with the criminal justice
system in designing treatment options.” See also Drake et al., supra note 26, at 1 (recognizing
current “intervention strategies and policies have failed, both, to assess the severity of the
problem in minority communities and to offer culturally sensitive preventative and treatment
solutions”).
Share this:
Rehabilitation Under the Rehabilitation Act: The Case for
Medication-Assisted Treatment in Federal Correctional
Facilities
Posted 4 years ago on Thursday, October 7th, 2021
Boston University School of Law
765 Commonwealth Avenue, Boston, Massachusetts 02215
RSS
C.Agnello SE 0476
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 480 of 569 PageID #:
674
EXHIBIT V
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0477
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 481 of 569 PageID #:
675
Briefing to the OPTN Board of Directors on
Ethical Evaluation of Multiple Listing
OPTN Ethics Committee
Prepared by: Stryker-Ann Vosteen, MPA and Cole Fox, MPA
UNOS Policy and Community Relations Department
Contents
Executive Summary 2
Purpose 3
Background 3
Overall Sentiment from Public Comment 5
White Paper for Consideration 12
Compliance Analysis 12
Conclusion 13
Ethical Evaluation of Multiple Listing 14
Appendix A: Data Requests 30
Addendum to “Ethical Evaluation of Multiple Listing: A Comprehensive Response to Public Comment” 39
C.Agnello SE 0478
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 482 of 569 PageID #:
676
Ethical Evaluation of Multiple Listing
Sponsoring Committee: Ethics
Public Comment Period: January 19, 2023 – March 18, 2023
Board of Directors Meeting: June 26, 2023
Executive Summary
Multiple listing as a policy permits patients to be listed at multiple transplant programs and accept organ
offers from more than one transplant program simultaneously. The purpose of the Ethical Evaluation of
Multiple Listing white paper is to provide an analysis of multiple listing in relation to equity (including
distributive justice and procedural justice), autonomy, and utility, which are the foundation of an ethical
transplant system. In addition to the ethical analysis, the OPTN Ethics Committee (hereafter, the
Committee) examined data regarding the prevalence of multiple listing, whether it confers an advantage
in likelihood of transplant, and the sociodemographic patterns of utilization of multiple listing.
Since multiple listing tends to be used by patients with higher socioeconomic status and is associated
with higher transplant rates compared to single listed candidates, it may exacerbate existing disparities
with equitable access to transplant. 1 The Committee affirms in its ethical analysis that:
• There is a need for optimizing access to multiple listing for pediatric patients, candidates who
list at Veterans Affairs (VA) hospitals and highly sensitized candidates
• Providing better financial support and more consistent information about multiple listing and
multiple evaluations for patients may reduce inequities
• Not allowing transplant programs to deny listing a patient because they want to be multiply
listed would ensure more consistent treatment for all patients
1 Katrina Gauntt, Keighly Bradbrook, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Kidney and Liver
Candidates by Geography,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee,
September 14, 2022.
2 Briefing Paper
C.Agnello SE 0479
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 483 of 569 PageID #:
677
Purpose
The purpose of this white paper is to conduct an ethical analysis of multiple listing and the implications
of how the practice impacts the transplant system. The Committee conducted two data requests to
examine the prevalence of multiple listing, whether it confers an advantage in likelihood of transplant,
and examined the sociodemographic patterns of utilization of multiple listing. The purpose of reviewing
these data was to complement the ethical analysis and provide feedback to the Board that is most
relevant and grounded in current evidence. Ultimately, this white paper answers the question “What are
the ethical implications of permitting patients to be listed at multiple transplant programs?”
Background
Policy
This ethical analysis was conducted in consideration of the existing multiple listing policies. Multiple
listing is established by OPTN Policy 3.4.F: Multiple Transplant Program Registrations, which permits
transplant candidates to register for an organ at multiple transplant programs. 2 Additionally, OPTN
Policy 3.2: Notifying Patients of Their Options requires transplant programs to inform the patient that
they have the option to register at multiple transplant programs, and whether that transplant program
accepts patients with multiple registrations. 3 Although current policy requires that patients be informed
of this option, compliance with the requirement is not actively monitored, so it is difficult to ascertain
the degree to which transplant programs comply with this policy. It is also difficult to assess the degree
to which patients understand and can act on the knowledge of multiple listing.
Since the OPTN Board of Directors last considered modifying multiple listing policy in 2003, the practice
has continued to generate controversy regarding its potential impact, equity, and benefit. 4,5,6,7,8 While
changes to the multiple listing policy have been considered by the Board previously, the ethical
implications of the policy have not. 9,10,11 The history of OPTN consideration of changing multiple listing
policy is extensively reviewed in the January 2023 multiple listing public comment proposal. 12
The white paper uses the following definitions in reference to the ethical principles of transplant:
2 OPTN Policy 3.4.F Multiple Transplant Program Registrations, 2022.
3 OPTN Policy 3.2 Notifying Patients of Their Options, 2022.
4 OPTN/UNOS Board of Directors Meeting Minutes, November 20-21, 2003, Richmond, Virginia
5 Nino Dzebisashvili et al., “Following the Organ Supply: Assessing the Benefit of Inter-DSA Travel in Liver Transplantation,”
Transplantation 95, 2 (Jan 2013). https://doi.org/ 10.1097/TP.0b013e3182737cfb.
6 Eitan Neidich et al., “Consumerist Response to Scarcity of Organs for Transplant,” AMA Journal of Ethics 15, 11 (Nov 2013):
966-972. https://doi.org/10.1001/virtualmentor.2013.15.11.pfor2-1311.
7 Konrad Hoetzenecker, “Commentary: The Ethical Dilemma of Multiple Listing,” Seminars in Thoracic and Cardiovascular
Surgery 34, 1 (March 2022): 336. https://doi.org/10.1053/j.semtcvs.2021.04.045.
8 Gebhard Waegener, “Multiple Listings: Good for a Few, but No Solution for the Organ Shortage,” Transplantation 104, 4 (Apr
2020). https://doi.org/10.1097/TP.0000000000002966.
9 United Network for Organ Sharing Board of Directors Meeting, March 21, 1988, Washington D. C.
10 United Network for Organ Sharing Board of Directors Meeting Transcript, March 1-2, 1995, New Orleans, Louisiana.
11 OPTN/UNOS Board of Directors Meeting Minutes, November 20-21, 2003, Richmond, Virginia
12 OPTN Ethics Committee, Ethical Evaluation of Multiple Listing Public Comment Proposal, pg 3-5. January 2023,
https://optn.transplant.hrsa.gov/media/l5odohtm/ethical-evaluation_multiple-listing_white-paper_ethics_pc-winter-2023.pdf
3 Briefing Paper
C.Agnello SE 0480
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 484 of 569 PageID #:
678
Ethical Principles
•
Equity “refers to fairness in the pattern of distribution of the benefits and burdens of an organ
procurement and allocation program.” 13
o
Distributive justice in organ allocation is defined as dictating “fairness in the distribution
of scarce resources so that similarly needy patients have an equal opportunity to benefit
from transplantation.” 14
o “Procedural justice refers to appraisal of the fairness of how decisions are made.” 15
•
“The concept of respect for autonomy holds that actions or practices tend to be right insofar as
they respect or reflect the exercise of self-determination.” 16 Notably, autonomy of one
individual cannot impair the autonomy of another individual.
•
“The principle of utility, applied to the allocation of organs, thus specifies that allocation should
maximize the expected net amount of overall good (that is, good adjusted for accompanying
harms), thereby incorporating the principle of beneficence (do good) and the principle of non-
maleficence (do no harm).” 17
These ethical principles are the foundation of an ethical transplant system and require thoughtful
deliberation to ensure the system continues to operate as intended. Each of the above-mentioned
principles is detailed in the analysis and its connection to multiple listing is emphasized. In this revised
draft, the role of autonomy is clarified and explained in further detail, as it was a focus of public
comment feedback.
Review of Data
To review current evidence relevant to the ethical implications of multiple listing, the Committee
submitted two data requests which depict patient access and geographic variability in multiple
listing. 18,19 The intent of these data requests was to better understand the accessibility of multiple listing
and did not review the outcomes of patients who were single versus multiple listed. The data
supplements the ethical analysis by depicting the connection between the theoretical and the practical.
The Committee examined data regarding multiple listing to consider whether patients can equally utilize
the practice and whether it confers an advantage in the likelihood of obtaining a transplant.
13 OPTN Ethics Committee, Ethical Principles in the Allocation of Human Organs, June 2015,
https://optn.transplant.hrsa.gov/professionals/by-topic/ethical-considerations/ethical-principles-in-the-allocation-of-human-
organs/.
14 OPTN Ethics Committee, Manipulation of the Organ Allocation System Waitlist Priority through the Escalation of Medical
Therapies, June 2018, https://optn.transplant.hrsa.gov/media/2500/ethics_whitepaper_201806.pdf.
15 Mark Fondacaro, Bianca Frogner, and Rudolf Moos, “Justice in Health Care Decision-Making: Patients’ Appraisals of Health
Care Providers and Health Plan Representatives,” Social Justice Research 18, 1 (Mar 2005): 63-81.
https://doi.org/10.1007/s11211-005-3393-3.
16 OPTN Ethics Committee, Ethical Principles, June 2015.
17 Ibid.
18 Keighly Bradbrook, Katrina Gauntt, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Candidates By Organ
Type,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee, May 11, 2022.
19 Katrina Gauntt, Keighly Bradbrook, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Kidney and Liver
Candidates by Geography,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee,
September 14, 2022.
4 Briefing Paper
C.Agnello SE 0481
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 485 of 569 PageID #:
679
Findings
The data analysis and ensuing discussions by the Ethics Committee indicate that multiple listing may
conflict with improving equity in access to transplant. Multiple listed kidney and liver candidates have
higher transplant rates compared to single listed candidates, while these multiple listed liver and kidney
candidates are less likely to be on Medicaid, more likely to have private insurance, and less likely to
report lower education levels. 20 This implies that while the current multiple listing policy complies with
formal equality of opportunity by being available to all patients, it does not demonstrate fair equality of
opportunity, which requires that all have a genuine and similar opportunity to achieve a particular
end. 21 In the case of multiple listing, this would mean that all patients can similarly demonstrate and
meet criteria necessary for multiple listing, as opposed to just being informed that multiple listing is
permissible. Thus, the data suggest that multiple listing provides an advantage that not all patients can
equally exercise.
Overall Sentiment from Public Comment
The proposal was released for public comment from January 19, 2023 to March 18, 2023. It received 274
comments out of a total of 2,735 comments received on all projects out for public comment this cycle.
Respondents were able to participate through in-person/virtual regional meetings, committee meetings,
and a form on the OPTN website. Demographic information was collected from all respondents,
including state of origin and stakeholder association. 22 The comments received represented at least 35
states across the country and all member types, with the greatest participation coming from organ
procurement organizations and transplant hospitals. 23 It is important to consider the demographics
participating in the public comment relevant to this proposal thereby ensuring that the ultimate
recommendation to the Board represents all stakeholders, even those whose volume of participation
may be lower.
The sentiments collected reflected a mixture of support and opposition, as indicated by a Likert score of
3.1. 24 There were concerns about restricting patient autonomy related to the recommendation to limit
multiple listing policy to difficult to match patients. Another area of feedback was potential unintended
consequences of restricting access to multiple listing to difficult to match patients, and questions about
how a limited multiple listing policy would work. Continuous distribution was noted as potentially
mitigating the impact of inequity in multiple listing, as well as negating the potential need to use
multiple listing (and the need to address its inequity by limiting its access). However, strong support was
20 Multiple listed kidney patients were one-third as likely to be on Medicaid compared to single listed kidney patients(4.8%
versus 13.2%), and multiple listed liver patients were a quarter as likely to be on Medicaid compared to singly listed liver
patients. Multiple listed kidney and liver transplant patients were disproportionately more likely to have private insurance or
private pay compared to single listed kidney transplant patients 53.5% versus 43.3%) and liver patients (68.8% versus 50.8%),
respectively. Multiple listed kidney and liver candidates were less likely to have reported an education level of grade school or
less compared to single listed kidney (3.5% versus 8%) and liver (3.4% versus 7.5%) candidates, respectively. Multiple listed
kidney and liver candidates were also less likely to have reported an education level High School or GED to single listed kidney
(30.1% versus 37.2%) and liver (27.3% versus 35.8%) candidates, respectively.
21 Barry Goldman and Russell Cropanzano, “”Justice” and “fairness” are not the same thing,” Journal of Organizational Behavior
31, 2 (Feb 2015): 313-318. https://doi.org/10.1002/job.1956.
22 Respondents at regional meetings represent the perspective of an institution, therefore their demographic information
represents that of the institution and not the individual submitting the comment.
23 Most attendees at regional meetings are transplant programs which accounts for the large volume of sentiment scores from
transplant programs.
24 Sentiment was collected on a 5-point Likert scale from strongly oppose to strongly support (1-5).
5 Briefing Paper
C.Agnello SE 0482
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 486 of 569 PageID #:
680
also expressed for the Committee’s effort to address inequities resulting from multiple listing and to
strengthen trust in the transplant system, even when members did not support all of the
recommendations in the original public comment draft.
The white paper was not supported by most of the stakeholders who provided feedback (the exception
being the International Society for Heart and Lung Transplantation (ISHLT), which considered the white
paper a good resource even if continuous distribution solved most of the issues with multiple listing).
Stakeholders expressing concerns included the American Society of Nephrology (ASN), Transplant
Families, American Society of Transplant Surgeons (ASTS), North American Transplant Coordinators
Organization (NATCO), American Society of Transplantation (AST), American Nephrology Nurses
Association (ANNA), and the Society of Pediatric Liver Transplantation (SPLIT). Most concerns from these
stakeholders centered around discomfort with imposing limitations on multiple listing as an option that
patients may pursue. Some stakeholders (ANNA, ASN, and NATCO in particular) noted support for the
efforts of the white paper to enhance equity but still expressed concern about the potential impact of
trying to limit the application of multiple listing. SPLIT identified living donor transplants as an important
option for pediatric candidates, a vulnerable population, and stressed the importance of leaving
multiple listing as an option for candidates such as these that seek living donation but should still have
the option to list elsewhere for a deceased donor organ.
Several OPTN Committees considered the white paper – Kidney, Liver, Patient Affairs, Minority Affairs,
Transplant Coordinators (TCC), Transplant Administrators (TAC), Lung, Pediatric, and Histocompatibility.
Many of these groups had mixed feedback – applauding the Ethics Committee for addressing inequities
in the system, while expressing concerns about how the proposed changes, if adopted by the Board,
would actually be applied. The comments mirrored those in the community: concern about unintended
consequences, support for addressing barriers in access to transplant for those with low socioeconomic
status, and questions about overlap with continuous distribution.
6 Briefing Paper
C.Agnello SE 0483
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 487 of 569 PageID #:
681
Figure 1 shows sentiment by member type. All member types were represented, with the highest
number of comments from transplant hospitals. Support was stronger among patients and the general
public compared to stakeholder organizations and transplant hospitals, which had the lowest support
for the white paper.
Figure 1: Sentiment by Member Type
7 Briefing Paper
C.Agnello SE 0484
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 488 of 569 PageID #:
682
Figure 2 shows sentiment by region. The white paper was supported most strongly in regions 6 and 10.
Regions 7 and 9 were also overall supportive, and regions 1, 2, 5, 8, and 11 were mixed in their
sentiment. Regions 3 and 4 were opposed.
Figure 2: Sentiment by Region
8 Briefing Paper
C.Agnello SE 0485
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 489 of 569 PageID #:
683
Public Comment Themes
Feedback from the community varied by region and by stakeholder type, and perspectives differed
greatly within these categories as well. However, three themes were present consistently in public
comment discussions of the multiple listing white paper: 1) concerns about the impact on patient
autonomy, 2) the potential for unintended consequences of removing multiple listing as an option from
policy for all patients except those difficult to match, and 3) support for the importance of tackling
equity issues in the transplant system. These themes and the Committee’s responses are reviewed
below.
Patient Autonomy
The white paper issued for public comment recommended that the Board remove policy allowing
multiple listing as an option except for difficult to match patients. There was a considerable amount of
feedback during public comment concerned about this recommendation and its potential impact on
patient autonomy. Commenters identified that challenges with insurance are imbedded in discussions of
socioeconomic disparities and the recommendations limiting access would not address those challenges
and suggested that acting on the recommendations in the white paper would restrict patient autonomy
without addressing or solving the inequity identified. Concerns about patient autonomy were raised by
almost all the stakeholder organizations, most of the regions, Board members, and some of the
committees that reviewed the proposal as well. 25
These comments were discussed at length during the Ethics Committee’s in person meeting in deciding
what changes would be appropriate to make post-public comment. The Committee noted that
autonomy is defined in the paper and the particular issue of restricting access was addressed in the
white paper as well. Specifically, the white paper identified that limitations on autonomy may be
warranted if doing so acts as redress to perpetuating inequities in access to transplant. The Committee
identified that greater clarity regarding what exactly is meant by ‘autonomy’ – and what is not meant –
could be potentially helpful in addressing public comment feedback.
The Committee considered that simply not being able to address all inequities (insurance,
socioeconomic barriers, etc.) is not a reason to not address potential inequity in access to multiple
listing. The Committee also discussed at their in-person meeting that multiple listing is often brought up
as a perceived inequity, as well as an actual one, and may impact public trust in the transplant system.
Therefore, much of the substance of the ethical analysis within the white paper was retained as
reflecting relevant implications about equity and public trust that the transplant community should
consider.
The Committee acknowledged that there are various ways the Board could optimize multiple listing and
consider impacts on autonomy. Therefore, the Committee removed its recommendations, while still
highlighting the most important findings from the analysis for any next steps that the Board considers
appropriate to pursue. The Committee also added an addendum to the paper for further clarity
regarding questions raised during public comment, including those focused on patient autonomy.
25 Importantly, these concerns were shared by the Patient Affairs and Minority Affairs Committees, two important stakeholders
to consider in terms of equity in access for patients and implications of socioeconomic disparities.
9 Briefing Paper
C.Agnello SE 0486
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 490 of 569 PageID #:
684
Unintended Consequences
Another theme heard during public comment was concern about unintended consequences if the
recommendations in the white paper were adopted. Commenters questioned restricting multiple listing
to difficult to match patients when other patient groups may benefit from it, and highlighted that
implementation efforts of continuous distribution allocation frameworks may address some of the
inequities associated with multiple listing. These concerns about unintended consequences are detailed
below, along with Committee responses.
Restricting Access to Multiple Listing to Difficult to Match Patients
Some commenters discussed the potential unintended consequences of limiting patient access to
multiple listing. Public comment feedback provided a variety of instances in which multiple listing may
be beneficial to many different types of candidates:
• Veterans 26 who list at VA centers not near them as well as local center
• Pediatrics while they seek living donors
• Patients that may age out of center waitlisting practices
• Patients who may have socioeconomic access barriers but have family in another place who
could take care of them
• Patients who may be more comfortable with the team at one center but encouraged by the
center to list elsewhere if other centers are more aggressive or have different criteria; in these
cases, they may be reluctant to sever ties with the center with which they’ve worked most
closely
• Those living in medically underserved or rural areas may have better access through multiple
listing
• Those seeking living donation may still seek access to a deceased donor organ and should not be
restricted for doing so
The Committee acknowledged that the impact on vulnerable populations such as pediatrics and
candidates who list at VA hospitals should be incorporated in any effort to optimize multiple listing as a
practice, and the relevant conclusion about improving access to multiple listing for certain vulnerable
populations was modified accordingly.
How Limiting Multiple Listing Would Work
Community members expressed concerns with limiting multiple listing to difficult to match patients
without identifying who these patients would be. Similarly, feedback included questions regarding how
the logistics of implementing limitations to multiple listing would work; some comments noted the
challenges of limiting access to multiple listing when patient behavior may reflect changing
26 It was noted post-public comment that veterans may not be the only people who list at Veterans Affairs hospitals, and the
final white paper was updated to refer to “candidates who list at Veterans Affairs hospitals.” Details about the types of people
eligible to receive care at VA hospitals can be found at the VA website (see: https://www.va.gov/health-care/eligibility/) and is
also described in Code of Federal Regulations in the Civilian Health and Medical Program of the Department of Veterans Affairs
(CHAMPVA) - Medical Care for Survivors and Dependents of Certain Veterans (Code of Federal Regulations, Civilian Health and
Medical Program of the Department of Veterans Affairs (CHAMPVA) - Medical Care for Survivors and Dependents of Certain
Veterans, 87 FR 41600, July 13, 2022)
10 Briefing Paper
C.Agnello SE 0487
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 491 of 569 PageID #:
685
knowledge/comfort level of the transplant system and the patient’s own understanding of what would
be in their best interest.
Although the white paper gave examples of difficult to match patients (such as highly sensitized
candidates), the Committee declined to define the term in the white paper because it was beyond
scope. The Committee similarly identified in the white paper that how implementation of changes to
policy would occur is beyond scope and would be identified by other OPTN committees. The Committee
affirmed these stances as reflecting appropriate limitations of Ethics Committee purview in post-public
comment review.
Continuous Distribution
Another logistical concern was the overlap with efforts to implement continuous distribution. Some
members suggested delaying the recommendations of the Committee while continuous distribution was
being developed, since the continuous distribution effort specifically aims to improve equity in the
system, thus potentially negating the need for multiple listing. Another member suggested incorporating
attributes into upcoming continuous distribution efforts to prioritize access instead of limiting multiple
listing.
The white paper submitted for public comment in January acknowledged the potential impact of
continuous distribution and noted that the ongoing effort to move all allocation policy frameworks to
continuous distribution does not negate the importance of considering the ethical implications of
multiple listing in the current policy landscape. The Committee confirmed post-public comment that the
language was appropriate in expressing the current importance of evaluating the implications of
multiple listing while acknowledging it may be appropriate to re-evaluate in the future.
Support for Addressing Equity in Access
While there were concerns about the impact on patients if certain recommendations within the white
paper were enacted, others expressed strong support for the Ethics Committee directly addressing an
inequity in the transplant system. One member specifically noted the enhanced trust that the white
paper generates for donor families skeptical of the transplant system by acknowledging and providing
ideas for addressing inequities. In another example, a TAC member shared anecdotal feedback how
support for multiple listing can erode the longer that an individual works in transplant, because of
seeing firsthand who gets access to this option (namely that multiply listed candidates tend to be
wealthier and more educated). One comment shared that prioritizing highly sensitized candidates would
also positively impact access for non-White women, who face greater barriers in access to transplant
compared to other groups. 27
This feedback affirmed the Committee’s approach in exploring potential inequities implied by multiple
listing and highlighted the importance of the ethical analysis provided within the white paper.
27 Am J Transplantation. 2006;6:2556-2562. 2. Tambur AR, Campbell P, Claas FH, et al. Sensitization in transplantation:
assessment of risk (STAR) 2017 working group meeting report. Am J Transplant. 2018;18:1604-1614. 3. Tambur AR, Campbell P,
Chong AS, et al. Sensitization in transplantation: assessment of risk (STAR) 2019 working group meeting report. Am J Transplant.
2020;20:2652-2668.
11 Briefing Paper
C.Agnello SE 0488
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 492 of 569 PageID #:
686
White Paper for Consideration
The Committee modified the white paper in several key respects: to provide additional clarity regarding
the discussion of patient autonomy; to include additional vulnerable populations for consideration in
optimizing access to multiple listing (specifically, pediatrics and candidates who list at VA hospitals); and
to remove specific recommendations regarding policy. The Committee kept the ethical analysis intact, in
affirmation of its importance in exploring implications of equity within the transplant system, and
highlighting relevant findings identified from the analysis:
• There is a need for optimizing access to multiple listing for pediatric patients, candidates who
list at VA hospitals and highly sensitized candidates
• Providing better financial support and more consistent information about multiple listing and
multiple evaluations for patients may reduce inequities
• Not allowing transplant programs to deny listing a patient because they want to be multiply
listed to ensure more consistent treatment for all patients
The Committee also provided to the white paper an addendum highlighting common questions and
pertinent answers for enhanced readability.
Compliance Analysis
NOTA and OPTN Final Rule
This white paper is proposed under the authority of NOTA, which requires the OPTN to establish "a
national list of individuals who need organs" 28 and the Final Rule, which requires every transplant
program to "assure that individuals are placed on the waiting list as soon as they are determined to be
candidates for transplantation." 29 The Ethics Committee offers the proposed white paper to provide the
OPTN Board and committees with the ethical implications of multiple listing practices.
OPTN Strategic Plan
This white paper is in alignment with the following aspect of the OPTN Strategic Plan:
Improve equity in access to transplants:
This white paper analyzes the practice of multiple listing and its impact on equity in access to transplant.
Multiple listed candidates have higher transplant rates than single listed candidates, indicating a
potential advantage in access to transplant. At the same time, multiple listed candidates are more likely
to reflect socioeconomic advantages in insurance and education. 30 Together, these trends suggest
multiple listing may be perpetuating an inequity. Analyzing potential inequities and exploring the
implications serve the ultimate goal of improving equity in access to transplant.
28 42 U.S.C. §274(b)(2)(A)(i)
29 42 C.F.R. §121.5(b)
30 Katrina Gauntt, Keighly Bradbrook, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Kidney and Liver
Candidates by Geography,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee,
September 14, 2022.
12 Briefing Paper
C.Agnello SE 0489
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 493 of 569 PageID #:
687
Conclusion
The Ethical Evaluation of Multiple Listing white paper identifies that multiple listing may perpetuate
inequities and that there are opportunities for optimizing access to the practice, providing better
support for those who may most need access to it, and considering the impact of transplant programs
being able to deny listing to patients who wish to be multiply listed. This white paper was modified in
response to public comment to expand relevant populations who should be considered in optimizing
access to multiple listing, to clarify the extent of patient autonomy and its implications within the paper,
to remove recommendations in acknowledgement of the OPTN Board’s purview over next steps to
address potential inequities in the transplant system, and to add an addendum answering common
questions about the analysis.
13 Briefing Paper
C.Agnello SE 0490
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 494 of 569 PageID #:
688
Ethical Evaluation of Multiple Listing
1 Introduction
2 Multiple listing is an opportunity for transplant candidates to be registered at and receive offers from
3 more than one transplant hospital simultaneously, which has raised ethical questions throughout the
4 last three decades but has not undergone a formal analysis by the Ethics Committee (hereafter ‘the
5 Committee’). Policy permitting multiple listings was initially passed by the OPTN Board of Directors in
6 1987, but faced repeal attempts in 1988, 1994, and 2001 associated with the concern that permitting
7 multiple listings favored wealthy patients who had the means to travel while disadvantaging those who
8 did not. 31,32,33,34 In response to these repeal attempts, multiple listing was prohibited from January to
9 March 1988, but has been a permanent component of OPTN policy since that time. 35 Currently, OPTN
10 Policy 3.4 Multiple Transplant Program Registrations allows patients to be registered for an organ at
11 multiple transplant programs and allows transplant programs to determine whether or not to accept a
12 candidate who is listed at multiple transplant programs for an organ. 36 Additionally, OPTN Policy 3.2
13 Notifying Patients on their Options requires transplant programs to inform patients that they are able to
14 pursue listing at multiple programs. 37 While this practice is formally referred to as multiple registrations
15 in policy, the practice is more colloquially known as multiple listing, which is how it will be referred to
16 throughout this white paper.
17 The concerns evident in literature today echo arguments made in past debates. Historically, those
18 opposed to multiple listing believed the practice would be utilized by individuals with the financial
19 resources to fly across the country to obtain a transplant, thereby disadvantaging other patients and
20 exacerbating inequities. 38,39 Alternatively, those in support of multiple listing championed the use of the
21 policy for highly sensitized or medically urgent patients and recommended educating patients about the
22 option and informing patients if a program does not multiple list. 40,41,42 Ultimately, policy repeals have
23 failed in the past due to the agreement that patient access should not be limited, despite the disparities
24 that may persist. 43,44 An Addendum (page 26) covers the concerns received during the most recent
25 public discussions of multiple listing and Ethics Committee responses to these objections. This
26 endeavors to address, one by one, each of the issues members raised during public comment, hopefully
27 allaying any misgivings they might initially have had about the paper.
28 Justice in a system of organ donation and allocation is upheld by ensuring that allocation rules are
29 applied equitably and consistently. Although system-level allocation priorities and practices promote a
30 just and balanced distribution of benefits and burdens across all stakeholders, individual stakeholders
31 United Network for Organ Sharing Board of Directors Meeting, August 10, 1987, Atlanta, Georgia.
32 United Network for Organ Sharing Board of Directors Meeting, March 21, 1988, Washington D. C.
33 United Network for Organ Sharing Board of Directors Meeting, November 2-3, 1994, Atlanta, Georgia.
34 Report of the OPTN Patient Affairs Committee to the Board of Directors, November 15-16, 2001, Alexandria, Virginia.
35 UNOS Board of Directors Meeting, March 1988.
36 OPTN Policy 3.4.F Multiple Transplant Program Registrations, 2022.
37 OPTN Policy 3.2 Notifying Patients of Their Options, 2022.
38 United Network for Organ Sharing Board of Directors Meeting Transcript, March 1-2, 1995, New Orleans, Louisiana.
39 Report of the OPTN/Patient Affairs Committee to the Board of Directors, November 15-16, 2001, Alexandria, Virginia.
40 Report of the OPTN/Patient Affairs Committee to the Board of Directors, November 20-21, 2003, Alexandria, Virginia.
41 Richard J. Glassock, “National Kidney Foundation Response to UNOS Policy Proposal Statement Regarding the Listing of
Patients on Multiple Transplant Waiting Lists,” March 14, 1988.
42 Jack W. Owen, “American Hospital Association Comments on the Multiple Listing of Transplant Candidates,” March 17, 1988.
43 United Network for Organ Sharing Board of Directors Meeting, March 21, 1988, Washington D. C.
44 OPTN/UNOS Board of Directors Meeting Minutes, November 20-21, 2003, Richmond, Virginia.
14 Briefing Paper
C.Agnello SE 0491
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 495 of 569 PageID #:
689
31 may pursue non-standard and less accessible approaches of moving from one center to another or
32 listing at multiple centers to increase chances of transplantation. Although it may be understandable
33 why individuals may take actions to pursue lifesaving treatment, policies governing organ allocation at a
34 national level must consider potential for systemic inefficiencies and inequalities introduced when a
35 small set of individuals self-select to list at multiple centers, increasing their chances of transplantation
36 relative to others who do not, or cannot, multiple lists. For that reason, it is imperative to examine how
37 multiple listing impacts all patients, not just individually. This white paper considers the ethical
38 implication of permitting patients to receive organ offers, simultaneously, from more than one
39 transplant program, thus, potentially receiving more organ offers. This white paper aims to answer the
40 question, ‘What are the ethical implications of permitting patients to be listed at multiple programs?’
41 The Committee conducts this ethical analysis within the scope, purview, and mission to “to guide the
42 policies and practices of the OPTN related to organ donation, procurement, distribution, allocation, and
43 transplantation so they are consistent with ethical principles.” 45 The Committee must consider the
44 ethical principles described below as they pertain to the transplant community broadly: equity
45 (including distributive and procedural justice), utility, and autonomy.
46
Patient Autonomy and Access to Transplant
Autonomy entails that “actions or practices tend to be right insofar as they respect or reflect the
exercise of self-determination”, while not impairing the autonomy of another individual. 46
Equity “refers to fairness in the pattern of distribution of the benefits and burdens of an organ
procurement and allocation program.” 47
Distributive justice in organ allocation is defined as dictating “fairness in the distribution of scarce
resources so that similarly needy patients have an equal opportunity to benefit from
transplantation.” 48
“Procedural justice refers to appraisal of the fairness of how decisions are made.” 49
Efforts to protect autonomy may come into conflict with equity and distributive justice. The OPTN
supports a balance of ethical principles within the transplant system, which implies that limits to
patient autonomy exist. Similarly, efforts to address equity or justice cannot be considered in a
vacuum but are considered within the overall balance of ethical principles that support a robust and
transparent transplant system.
In the context of multiple listing, it is important to fully account for all the ethical principles that
support trust in the transplant system, and not just autonomy.
47
45 Ethics Committee, OPTN, accessed December 3, 2022. https://optn.transplant.hrsa.gov/about/committees/ethics-
committee/.
46 OPTN Ethics Committee, Ethical Principles in the Allocation of Human Organs, June 2015,
https://optn.transplant.hrsa.gov/professionals/by-topic/ethical-considerations/ethical-principles-in-the-allocation-of-human-
organs/
47 Ibid.
48 OPTN Ethics Committee, Manipulation of the Organ Allocation System Waitlist Priority through the Escalation of Medical
Therapies, June 2018, https://optn.transplant.hrsa.gov/media/2500/ethics_whitepaper_201806.pdf.
49 Mark Fondacaro, Bianca Frogner, and Rudolf Moos, “Justice in Health Care Decision-Making: Patients’ Appraisals of Health
Care Providers and Health Plan Representatives,” Social Justice Research 18, 1 (Mar 2005): 63-81.
https://doi.org/10.1007/s11211-005-3393-3.
15 Briefing Paper
C.Agnello SE 0492
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 496 of 569 PageID #:
690
48 The core ethical concern associated with multiple listing involves ensuring equitable access to
49 transplantation and examining the level of advantage multiple listing provides over single listing. Recent
50 national reports and requests for information by Centers for Medicare & Medicaid Services (CMS) have
51 emphasized the importance of ensuring equitable access to transplant and removing or modifying
52 policies that perpetuate disparities experienced by structurally minoritized persons. 5051 Although
53 formally available to all, in practice, multiple listing is viewed as only being accessible for those with the
54 means and influence to seek an advantage in obtaining access to transplantation. 52 In order to pursue
55 multiple listing, the patient and their caregiver may need to travel to additional transplant programs for
56 transplant evaluation, attain lodging, receive time off work, and potentially pay for the additional
57 transplant evaluation if not covered by insurance. Media coverage of high-profile cases has raised
58 concerns over the use of multiple listing by exceptionally wealthy individuals that may be harmful to
59 public perception and imply that wealth and private transportation provide a disproportionate
60 advantage to accessing transplant. 53,54 Public trust is the basis for a successful transplant system, and
61 deterioration of trust may impact individual and donor family willingness to donate. A commitment to
62 balancing ethical principles and upholding public trust requires an ethical analysis of the multiple listing
63 policy.
64 The Committee supports greater transparency in transplant evaluation criteria and strongly supports
65 patients in their ability to pursue evaluation and listing at the transplant program that best aligns with
66 their needs, preferences, and clinical characteristics. Approaching multiple centers and completing
67 multiple evaluations in an attempt to find one that best supports patients’ needs is not considered
68 multiple listing as defined and discussed in this white paper. 55 As described in the Transparency in
69 Program Selection white paper, programs may vary significantly in their evaluation practices, donor
70 acceptance practices, and utilization of marginal organs, among other factors. 56 Some of these factors
71 may be known and understood by patients at the point of evaluation and listing, while other factors may
72 become apparent only after listing at a given program. Access to multiple evaluations and ensuring that
73 waiting time follows patients to any program upholds patient autonomy and efficiency. This encourages
74 patients to find transplant program that best meet their goals and preferences and supports transplant
75 programs in efforts to improve transparency about their evaluation and listing process.
76 The overarching question, ‘What are the ethical implications of permitting patients to be listed at
77 multiple centers?,’ will be answered by analyzing the ethical principles of equity (including distributive
78 and procedural justice), autonomy, and utility as they pertain to multiple listing. Each ethical principle
79 was analyzed, practically applied to multiple listing, and the relevant data considered OPTN data
50 National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The
National Academies Press. https://doi.org/10.17226/26364.
51 “Request for Information: Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and
End-Stage Renal Disease Facilities.” Centers for Medicare & Medicaid Services (CMS). Dec. 03, 2021. Available at:
https://www.federalregister.gov/documents/2021/12/03/2021-26146/request-for-information-health-and-safety-
requirements-for-transplant-programs-organ-procurement
52 Eitan Neidich et al., “Consumerist Response to Scarcity of Organs for Transplant,” AMA Journal of Ethics 15, 11 (Nov 2013):
966-972. https://doi.org/10.1001/virtualmentor.2013.15.11.pfor2-1311.
53 Denise Grady and Barry Meier, “A Transplant That Is Raising Many Questions,” The New York Times, June 22, 2009.
54 Marilynn Marchione, “Organ transplant lists in the US favor the rich, according to new study,” Associated Press, Nov 9, 2015.
55 The OPTN Ethics Committee is a proponent of patients exercising their autonomy through the transplant evaluation process
by identifying the transplant program that best aligns with their needs, preferences, and values to assist their decisions-making
in the transplant program selection process. See: OPTN Ethics Committee, Transparency in Program Selection, August 2022,
https://optn.transplant.hrsa.gov/media/05elwuzv/bp_transparency-in-program-selection_ethics.pdf.
56 Ibid.
16 Briefing Paper
C.Agnello SE 0493
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 497 of 569 PageID #:
691
80 pertaining to each principle. The white paper will show that inequities perpetuated by multiple listing
81 may conflict with the guiding principles of equity and utility. 57 The Committee recognizes the following:
82 • There is a need for optimizing access to multiple listing for pediatric patients, candidates who
83 list at Veterans Affairs (VA) hospitals 58 and difficult to match candidates through multiple listing
84 • Providing better financial support and more consistent information about multiple listing and
85 multiple evaluation for patients may reduce inequities
86 • Not allowing transplant programs to deny listing a patient because they want to be multiply
87 listed would ensure more consistent treatment for all patients
88 Review of Relevant Data
89 Utilization of Multiple Listing, February 4, 2020 – March 31, 2022
90 In congruence with the ethical analysis, OPTN data were reviewed to better understand patient access
91 and the implications of multiple listing for improving the likelihood of transplantation. 59,60 As previously
92 mentioned, the Committee defined multiple listing as “being on the transplant wait-list for a particular
93 organ type at more than one transplant program simultaneously,” as opposed to identifying patients
94 who had ever been listed at more than one program. 61 During this two-year period, the sample size of
95 patients who are multiple listed is relatively small, with only 6.4% of registered candidates listed at two
96 or more transplant hospitals for the same organ on December 31, 2021. 62 Kidney had the largest
97 percentage of candidates multiple listed at 7.2%, liver at 1.5%, and thoracic organs were less than 1%
98 each. 63
99 First, the Committee reviewed the demographics and geography of patients who were single and
100 multiple listed. This analysis used patients waitlisted on December 31, 2021, as a representative sample
101 of what the waitlist could look like on a given day. 64 The Committee examined the utilization of multiple
102 listing across all organ types, individual-level demographics (age, sex, race/ethnicity, insurance status,
103 education, blood type) and geocoded zip code level demographics (median household income, poverty
104 percent). Registration-level data, depicting region, time to transplant, medical urgency status, time
105 between primary and secondary listing hospital, distance between primary and secondary listing
106 hospital, and location of most common primary, secondary, and tertiary listings, were also assessed. 65
57 OPTN Ethics Committee, Ethical Principles in the Allocation of Human Organs, June 2015,
https://optn.transplant.hrsa.gov/resources/ethics/ethical-principles-in-the-allocation-of-human-organs/.
58 Details about the types of people eligible to receive care at VA hospitals can be found at the VA website (see:
https://www.va.gov/health-care/eligibility/) and is also described in Code of Federal Regulations in the Civilian Health and
Medical Program of the Department of Veterans Affairs (CHAMPVA) - Medical Care for Survivors and Dependents of Certain
Veterans (Code of Federal Regulations, Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) -
Medical Care for Survivors and Dependents of Certain Veterans, 87 FR 41600, July 13, 2022)
59 Keighly Bradbrook, Katrina Gauntt, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Candidates By Organ
Type,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee, May 11, 2022.
60 Katrina Gauntt, Keighly Bradbrook, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Kidney and Liver
Candidates by Geography,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee,
September 14, 2022.
61 Decoteau et al., “The Advantage.”
62 Bradbrook, “Data Request,” May 11, 2022.
63 Ibid.
64 Bradbrook, “Data Request,” May 11, 2022.
65 Heart and lung were combined into one group, thoracic, due to small sample size. Primary listings are defined as the initial
transplant center a patient listed at, while secondary listings are as the second transplant hospital that a given patient was
listed for transplant at.
17 Briefing Paper
C.Agnello SE 0494
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 498 of 569 PageID #:
692
107 Further analysis included a review of multiple listing practices between February 4, 2020, and December
108 31, 2021 for liver patients and March 15, 2021 to December 31, 2021 for kidney patients. 66 In particular,
109 transplant rates, calculated as the number of transplants per 100 inactive and active years waiting, were
110 analyzed for cohorts post-acuity circles and stratified by whether the multiple listing occurred in the
111 same donor service area (DSA), outside the DSA but in the first priority circle, or outside of the first
112 priority circle. Transplant rates were used to further illuminate any shifts in allocation from DSA to acuity
113 circles in order to consider the role that changing allocation systems has had on multiple listing
114 practices. Additionally, transplant rates were calculated based on an ever-waiting cohort from
115 implementation of acuity circles to March 31, 2022. For liver this was candidates ever waiting between
116 February 4th, 2020, to March 31, 2022 and for kidney this was candidates ever waiting between March
117 15, 2021 to March 31st, 2022. 67 Candidates were indicated as ever multiple listed if at any point in the
118 cohort time frame the candidate had two or more listings at multiple programs simultaneously.
119 Candidate waiting time was considered by taking the time in days from the first listing date to either the
120 date of transplant or the date of candidate removal from all listings from the waitlist, including both
121 active and inactive waiting time for the candidate. 68
122 It is important to note that as allocation changes, the role and impact of multiple listing evolves in
123 tandem. 69 OPTN data reflects changes in listing behavior and the subsequent impact of multiple listing
124 as allocation shifted from DSA to acuity circles. It is fair to hypothesize that the development of
125 continuous distribution, an allocation framework that deemphasizes geography, will continue to affect
126 the role, benefit, and prevalence of multiple listing. The relevant themes from the data will be analyzed
127 in juxtaposition to the ethical principles of equity (including distributive and procedural justice), utility,
128 and autonomy.
129 Limitations to the analysis: It is important to note that zip code data, which were utilized to depict the
130 median household income and poverty levels for single and multiple listed kidney, liver, and thoracic
131 patients, have limitations. Aggregated environmental factors are not always good descriptors of an
132 individual’s access, situation, barriers, and personal situation, as these individual-level situations often
133 attenuate any disadvantage that may be conferred by one’s environment. While zip code data offers
134 comparisons of multiple and single listed patients on aggregate, it falls short in providing the level of
135 granularity that would be provided by candidate-level socio-economic measures, which are not available
136 in OPTN data as patient addresses are not collected. Future analyses would benefit from incorporating
137 third-party data with OPTN data to look at the effect of multiple listing on equity and access to
138 transplant, adjusting for individual level socio-economic factors. Thoracic sample sizes are small and
139 future analyses would benefit from using a larger cohort when more data are available. Further
140 limitations include data quality for self-reported information, such as zip code, and the occurrence of
141 patients being listed at two programs on the same day, which were excluded from the analysis. 70,71
66 Gauntt, “Data Request,” September 14, 2022.
67 “Ever waiting” is inclusive of candidates who spent any time waiting during the time period described - whether the
candidate was on the waiting list the entire time period or a shorter subset
68 Additional details about the methods can be found in Appendix A.
69 Decoteau et al., “The Advantage.”
70 Arline T. Geronimus, John Bound & Lisa J. Neidert, “On the Validity of Using Census Geocode Characteristics to Proxy
Individual Socioeconomic Characteristics,” Journal of the American Statistical Association, 91 (1996): 529-537.
https://doi.org/10.1080/01621459.1996.10476918.
71 Bradbrook, “Data Request,” May 11, 2022.
18 Briefing Paper
C.Agnello SE 0495
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 499 of 569 PageID #:
693
142 Data Analysis Pertaining to Equity in Multiple Listing
143 To examine whether utilization is socially patterned in ways consistent with structural discrimination,
144 three variables (race/ethnicity, insurance status, and education) were explored. Table 1-1 depicts the
145 percentages of single and multiple listed kidney and liver patients by race/ethnicity, insurance status,
146 and education. 72,73,74
147 Table 1-1 (Race/Ethnicity, Insurance Status, and Education for Single and Multiple Listed Kidney and
148 Liver Patients)
Kidney – Kidney – Liver – Single Liver –
Single listed Multiple listed listed patient Multiple
patient patient listed patient
Race/ White, Non- 35.8% 36.3% 66.5% 72.2%
Ethnicity Hispanic
Black, Non-Hispanic 30.9% 36.1% 7% 5.7%
Hispanic/Latino 21.5% 16.3% 19.5% 15.9%
Asian, Non-Hispanic 9.2% 9.5% 5.1% 5.1%
Insurance Private or self pay 43.3% 53.5% 50.8% 68.8%
Status Medicaid 13.2% 4.8% 20.1% 5.7%
Medicare 75 40.3% 35.9% 23.6% 17.1%
Department of VA 1.6% 4.1% 2.1% 7.4%
Public or charity, 1.2% 1.4% 3.1% 1.1%
other 76
Education Grade school or less 8% 3.5% 7.5% 3.4%
High school or GED 37.2% 30.1% 35.8% 27.3%
Attended College/ 25% 26.1% 24.3% 26.7%
Technical School
Associate/Bachelor 19.1% 25.1% 19.9% 22.7%
Degree
Post-College 7.1% 12.0% 7.4% 11.9%
Graduate Degree
Unknown 3.3% 3.1% 3.5% 6.2%
149
150 Although there were fewer candidates reporting a Hispanic/Latino ethnicity in the multiple listed kidney
151 group there were more candidates reporting Black, Non-Hispanic ethnicity in the multiple listed kidney
152 group but fewer for liver, and very little difference among candidates reporting White, Non-Hispanic. 77
153 It is important to note that data reflect the patients who are successfully listed for transplant and
154 successfully multiple listed. It does not include those who have yet to be registered on the waitlist or
155 have been unsuccessful in their attempts to multiple lists, which could account for racial breakdown
156 highlighted above, or those who have successfully multiple listed and received a transplant.
72 Additional options for race/ethnicity are available for patients to self-identify and select, however, this Table 1-1 only reflects
patient responses with more than 5%.
73 Bradbrook, “Data Request,” May 11, 2022.
74 The full demographic comparison can be found in Appendix A, Table 1.
75 This includes both “Medicare FFS (Fee for Service)” and “Medicare & Choice” insurance options.
76 This includes all other public insurance or charity options, including: “CHIP (Children’s Health Insurance Program,” “Other
government,” “Donation,” “Free care,” and “Foreign Government, specify.”
77 Bradbrook, “Data Request,” May 11, 2022.
19 Briefing Paper
C.Agnello SE 0496
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 500 of 569 PageID #:
694
157 Multiple listed patients kidney patients were one-third as likely to be on Medicaid compared to single
158 listed kidney patients (4.8% versus 13.2%), and multiple listed liver patients were a quarter as likely to
159 be on Medicaid compared to singly listed liver patients. Multiple listed kidney and liver transplant
160 patients were disproportionately more likely to have private insurance or private pay compared to
161 single listed kidney transplant patients 53.5% versus 43.3%) and liver patients (68.8% versus 50.8%),
162 respectively. 78
163 Multiple listed kidney and liver candidates were less likely to have reported an education level of
164 grade school or less compared to single listed kidney (3.5% versus 8%) and liver (3.4% versus 7.5%)
165 candidates, respectively. Multiple listed kidney and liver candidates were also less likely to have
166 reported an education level High School or GED to single listed kidney (30.1% versus 37.2%) and liver
167 (27.3% versus 35.8%) candidates, respectively. 79
168 Some studies have shown that health literacy and higher socioeconomic status, sometimes proxied
169 through higher educational attainment or private insurance, have been associated with higher likelihood
170 of being referred to transplant, completing the transplant evaluation successfully, being waitlisted, and
171 obtaining a transplant. 80,81,82,83 When considering the benefits of private insurance, for example,
172 research shows that individuals with private insurance are more likely to be referred for liver transplant
173 when compared to publicly insured patients. 84 OPTN data clearly depict patients with private insurance
174 as comprising a larger proportion of multiple listed patients. This trend aligns with structural disparities
175 and questions of potentially unequal access between patients with private versus public insurance.
176 Navigating the transplant system is challenging and those with higher level of education are often more
177 successful in maneuvering these complexities to be successfully listed, and multiple listed, for
178 transplant. OPTN data confirm this by showing that those with advanced education are more likely to be
179 multiple listed when compared to single listed patients across all organ types. 85,86 Higher levels of
180 education often correspond with greater health literacy, while lower levels of health literacy are
181 negatively correlated with access to transplant. 87,88 Transplant candidates are a particularly vulnerable
182 population as the stress, anxiety, and general experience of not feeling well while living with an end
183 stage disease may contribute to a decreased ability to understand important information. The
184 complexity of the transplant evaluation and listing process and the high levels of digital health literacy
185 required to navigate multiple listing may further disadvantage marginalized and vulnerable groups. 89
78 Ibid.
79 Ibid.
80 Marie A. Chisholm-Burns, Christina A. Spivey, and Logan R. Pickett, “Health literacy in solid-organ transplantation: A model to
improve understanding,” Patient Preference and Adherence 12 (Nov 2018): 2325-2338. https://doi.org/10.2147/PPA.S183092.
81 Christine Park et al., “A scoping review of inequities in access to organ transplant in the United States,” International Journal
for Equity in Health 21, 22 (Feb 2022). https://doi.org/10.1186/s12939-021-01616-x.
82 K. Bartolomeo et al., “Factors Considered by Nephrologists in Excluding Patients from Kidney Transplant Referral,”
International Journal of Organ Transplantation Medicine 10, 3 (2019): 101-107.
83 Jerry McCauley et al., “Factors determining the rate of referral, transplantation, and survival on dialysis in women with
ESRD.” American Journal of Kidney Diseases 30, 6 (Dec 1997): 739-48. https://doi.org/10.1016/s0272-6386(97)90077-9.
84 Julius M. Wilder et al., “Role of patient factors, preferences and distrust in health care and access to liver transplantation and
organ donation,” Liver Transplantation 22, 7 (Mar 2016): 895-905. https://doi.org/10.1002/lt.24452.
85 Bradbrook, “Data Request,” May 11, 2022.
86 Decoteau, “The Advantage,” 2021.
87 Marie A. Chisholm-Burns, Christina A. Spivey, and Logan R. Pickett, “Health literacy in solid-organ transplantation: A model to
improve understanding,” Patient Preference and Adherence 12 (Nov 2018): 2325-2338. https://doi.org/10.2147/PPA.S183092.
88 Christine Park et al., “A scoping review of inequities in access to organ transplant in the United States,” International Journal
for Equity in Health 21, 22 (Feb 2022). https://doi.org/10.1186/s12939-021-01616-x.
89 Dominic M. Taylor et al., “Limited health literacy in advanced kidney disease,” Clinical Investigation 90, 3 (Sept 2016): 685-
695. https://doi.org/10.1016/j.kint.2016.05.033
20 Briefing Paper
C.Agnello SE 0497
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 501 of 569 PageID #:
695
186 Patients with high levels of digital literacy are more successful at navigating the complexities of the
187 healthcare system than those with limited internet access and health literacy. 90 To obtain the maximum
188 benefit from the vast amounts of information publicly available regarding the performance of organ
189 procurement organizations (OPO) and transplant programs, patients must have the tools and skills to
190 locate available information, understand and make use of the complex information available to them in
191 a way that impacts their health, and network with transplant professionals and other recipients who can
192 provide additional insight. 91 Beyond making an informed decision to seek out multiple listing, and at
193 which program(s), patients may need to self-advocate with their health care provider team and third-
194 party payer.
195 For example, digital literacy rates are three times lower for Hispanic adults when compared to white
196 adults, 92 which may influence the finding that Hispanic patients are less likely to be multiple listed
197 compared to single listed Hispanic patients seeking a kidney or liver transplant. 93 In contrast, Black
198 adults are twice as likely to be digitally illiterate than white adults, and yet black patients accounted for
199 nearly an equal percentage of kidney multiple listings as white patients. 94,95 While the findings for
200 Hispanic patients are consistent with the continued disparities in access to transplant for Hispanic
201 patients across the U.S., the findings for Black patients depict an increase in the proportion of Black
202 patients pursuing multiple listing for kidney compared to single listed Black kidney patients. 96 Health
203 literacy is essential for accessing transplant and without the relevant information, or the ability to
204 understand it, patients with a lower health literacy will continue to face barriers to equitable access.
205 Ultimately, the current policy allowing multiple listing complies with formal equality of opportunity by
206 being available to all patients, but as it currently is formulated it cannot alone promote fair equality of
207 opportunity. The data reviewed indicate that not all patients can equally exercise the option to multiple
208 lists, despite having equal access to multiple lists.
209 Ethical Analysis
210 Background
211 The Committee adopts Decoteau et al.’s definition of multiple listing, “being on the transplant wait-list
212 for a particular organ type at more than one transplant program simultaneously.” 97 The Committee
213 assessed whether multiple listing confers an advantage in terms of likelihood of transplantation;
214 whether this is equitably distributed; and whether any ethical principles would support widespread use
215 of multiple listing for any candidate who wishes to pursue it.
90 Kathy Harris, Gloria Jacobs, and Julie Reeder, “Health Systems and Adult Basic Education: A Critical Partnership in Supporting
Digital Health Literacy,” Health Literacy Research and Practice 3, 3 (Jul 2019): S33-S36. https://doi.org/10.3928/24748307-
20190325-02.
91 Chisholm-Burns, “Health,” 2018.
92 U.S. Department of Education, A Description of U.S. Adults Who Are Not Digitally Literate, Saida Mamedova and Emily
Pawlowski. NCES 2018-161, Washington, D.C.: 2018, https://nces.ed.gov/pubs2018/2018161.pdf (accessed Nov 4, 2022).
93 Bradbrook, “Data Request,” May 11, 2022.
94 U.S. Department of Education, A Description, 2018.
95 Bradbrook, “Data Request,” May 11, 2022.
96 Cristina M. Arce et al., “Differences in Access to Kidney Transplantation between Hispanic and Non-Hispanic Whites by
Geographic Location in the United States,” Clinical Journal of the American Society of Nephrology 8 (Dec 2013): 2149-2157.
https://doi.org/ 10.2215/CJN.01560213.
97 Mary A. Decoteau et al., ‘The Advantage of Multiple Listing Continues in the Kidney Allocation System Era,” Transplantation
Proceedings 53, 2 (Mar 2021): 569-580. https://doi.org/10.1016/j.transproceed.2020.10.036.
21 Briefing Paper
C.Agnello SE 0498
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 502 of 569 PageID #:
696
216 Equity
217 Concerns about multiple listing relate largely to promoting equitable access to transplantation, as
218 required by the Final Rule. 98 The concept of equity as it pertains to multiple listing may be understood as
219 one of fair versus formal equality of opportunity. Although frequently described in the context of
220 competitive advantage for the purposes of obtaining jobs and offices, the concept of fair versus formal
221 equity underscores the difference between a policy merely allowing a benefit to be available to all
222 (formal), versus one that requires that all are equally able to be considered for and have access to the
223 benefit (fair). 99 Corresponding to the idea of reducing the competitive advantages that favorable social
224 circumstances confer on some individuals in the context of job seeking, Rawls suggests “fair equality of
225 opportunity.” 100 Fair equality of opportunity requires that any individuals who have the same native
226 talent and the same ambition (or in the case of transplant, the same need and willingness to pursue
227 multiple listing) will have the same prospects of success in circumstances where success determines
228 future long term benefit (in this case access to life-saving treatment). 101,102
229 Formal equality of opportunity follows the notion that official rules should not exclude or disadvantage
230 individuals from achieving certain goals by making reference to personal characteristics, such as race,
231 socioeconomic status, gender, religion, gender identity, and sexuality, among other criteria. While
232 formal equality of opportunity speaks to equal consideration of all people, the challenge is that it is
233 merely formal, and formal equity is insufficient in achieving equality of opportunity because it is
234 conditional on people being able to fairly access the option and be considered. Instead, fair equality of
235 opportunity requires that all have a genuine and similar opportunity to achieve a particular end. In the
236 case of multiple listing, this would mean that all patients can similarly demonstrate and meet criteria
237 necessary for multiple listing, as opposed to just being informed that multiple listing is permissible.
238 Here too, the distinction between “equality” and “equity” or “formal” and “fair” becomes important. To
239 promote equitable access to transplantation, patients that face disproportionate challenges to being
240 matched for transplant may need to be listed at multiple programs to ensure that their likelihood of
241 transplantation is comparable to other patients on the waitlist. Although much public attention has
242 been focused on concerns of affluent patients receiving an unfair advantage by being waitlisted at
243 multiple locations, less attention has been paid to the equally important issue: the benefits of multiple
244 listing to patients who are disproportionately difficult to match, due to pre-sensitization, extreme size
245 matching, or relative contraindications.
246 If the goal is to ensure equitable access to transplantation, patients who are hardest to match with a
247 deceased-donor organ may require multiple listing to “level the playing field,” or have a similar
248 likelihood of receiving a transplant as other patients. This would reduce disparities in transplantation by
249 equalizing the likelihood of obtaining a transplant, particularly for populations that have reduced access
250 to transplant such as non-white women who are highly sensitized. 103 Similarly, optimizing access to
251 multiple listing for pediatric candidates and candidates who list at VA hospitals may be supported by
98 42 U.S.C. §274.
99 Barry Goldman and Russell Cropanzano, “”Justice” and “fairness” are not the same thing,” Journal of Organizational Behavior
31, 2 (Feb 2015): 313-318. https://doi.org/10.1002/job.1956.
100 John Rawls, A Theory of Justice: Revised Edition (Cambridge, Massachusetts: Harvard University Press, 1999), 57-64.
101 Ibid.
102 John Rawls, Justice as Fairness: A Restatement (Cambridge, Massachusetts: Harvard University Press, 2001), 42-50.
103 Am J Transplantation. 2006;6:2556-2562. 2. Tambur AR, Campbell P, Claas FH, et al. Sensitization in transplantation:
assessment of risk (STAR) 2017 working group meeting report. Am J Transplant. 2018;18:1604-1614. 3. Tambur AR, Campbell P,
Chong AS, et al. Sensitization in transplantation: assessment of risk (STAR) 2019 working group meeting report. Am J Transplant.
2020;20:2652-2668.
22 Briefing Paper
C.Agnello SE 0499
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 503 of 569 PageID #:
697
252 these groups being particularly vulnerable populations that require additional ethical considerations in
253 their access to transplant. Pediatric candidates often use multiple listing when pursuing the potential of
254 a living donor transplant, which may be offered at fewer centers, farther from their home when
255 compared to adult transplant centers. Veterans and sometimes their family members may list at
256 Veterans Affairs (VA) hospitals in addition to local centers, indicating there are structural issues in access
257 to transplant that imply multiple listing may be a necessary process for these candidates to pursue.
258 Distributive Justice
259 Numerous theories of distributive justice require us to consider the concerns of the worst-off, those
260 whom the existing allocation system and organ supply may not serve as well. 104,105,106 Patients who are
261 exceptionally difficult to match for reasons outside of their control may be unlikely to benefit from
262 organ transplantation without multiple listing and could be harmed if this policy were to constrain their
263 ability to access transplantation. Patients pursuing transplant, including patients on dialysis in need of a
264 kidney transplant, are doing their best to obtain the in dire need of life-saving treatment they are in dire
265 need of. Their individual reasons for pursuing multiple listing do not reflect these systemic moral
266 considerations about distributive justice. However, while transplantation cannot resolve or rectify all
267 existing social disparities, this fact does not absolve the transplant community from remediating the
268 policies that exacerbate disparities within transplantation. Optimizing multiple listing to support access
269 for difficult to match patients may help to mitigate a barrier impeding equitable access to
270 transplantation. Differences in program practices, selection practices, organ acceptance rates, and risk
271 aversion are reasons to justify multiple evaluations, but not necessarily multiple listing (the ability to
272 receive multiple offers simultaneously from different programs).
273 Procedural Justice
274 Procedural justice approaches are concerned with treating like with like, in other words, treating
275 persons of similar needs consistently, transparently, and predictably. 107 To uphold procedural justice,
276 transplant programs must notify patients of their ability to multiple list, which is a current requirement
277 when registering a patient on the waitlist. 108 Despite it being a requirement, how, when, and the
278 consistency with which transplant programs convey this information may vary. 109 Moreover, it remains
279 unclear how well patients understand this information. Finally, the degree to which programs are willing
280 to evaluate and list patients who are already listed at other programs varies, which can lead to
281 inconsistent practices for patients to navigate. 110
104 Distributive justice in organ allocation is defined as dictating “fairness in the distribution of scarce resources so that similarly
needy patients have an equal opportunity to benefit from transplantation.” See: OPTN Ethics Committee, Manipulation of the
Organ Allocation System Waitlist Priority through the Escalation of Medical Therapies, June 2018,
https://optn.transplant.hrsa.gov/media/2500/ethics_whitepaper_201806.pdf.
105 Paul Farmer, Pathologies of Power: Health, Human Rights, and the New War on the Poor, (Berkeley, California: University of
California Press, 2003).
106 National Research Council, “Realizing the Promise of Equity in the Organ Transplantation System,” 2022, Washington, DC:
The National Academies Press. https://doi.org/10.17226/26364.
107 OPTN Ethics Committee, Transparency.
108 OPTN Policy 3.2 Notifying Patients of Their Options, 2022.
109 While OPTN policy requires transplant hospitals to inform patients about multiple listing, policy does not dictate how this
must be done which introduces variability in presenting this information to patients. The subcommittee shared anecdotes of
how their respective centers inform patients of multiple listing, which confirmed the variability that policy allows.
110 OPTN Policy 3.4.F Multiple Transplant Program Registrations, 2022.
23 Briefing Paper
C.Agnello SE 0500
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 504 of 569 PageID #:
698
282 Application of Equity to Multiple Listing
283 In the case of multiple listing, formal equity exists through the requirement to inform patients about the
284 opportunity to multiple lists despite the possibility that this may not occur consistently. 111 Formally
285 providing notification that patients are able to be multiple listed does not equally result in patients
286 successfully multiple listing. Fair equality of opportunity would require additional assistance be provided
287 to those less able to act on this information, either those with less ability to multiple lists, or those less
288 able to understand the information about multiple listing and use that information to navigate multiple
289 listing. Fair equality of opportunity might include: the ability to understand and follow the steps
290 required to meet criteria for multiple programs; the resources (financial, time, transportation, support
291 person) to meet residency requirements at more than one location; complete evaluations; the ability
292 to arrive in time for a transplant; and the insurance coverage to allow for multiple evaluations.
293 There may be a variety of steps needed to ensure such fair equality of opportunity to those patients at a
294 disadvantage. Patient navigation or more accessible education materials can be made available for
295 patients with limited health literacy. Some possible solutions to help those with limited means to meet
296 criteria for multiple listing include greater education, providing scholarships to cover housing or other
297 expenses, redistributing resources to promote with health literacy, waiving residency criteria, and
298 lobbying insurers to cover additional transplant evaluations, and ensuring that multiple listing is
299 encouraged especially for patients who face greater difficulty in being matched with an organ. As more
300 is done to provide opportunities that enable persons from any social group to meet multiple listing
301 criteria, the objection that none but the financially, educationally, or socially better off may benefit from
302 multiple listing is overcome. At some point, depending on the availability of such resources, sufficient
303 opportunities to achieve multiple listing may be achieved, and fair equality of opportunity would prevail.
304 However, the transplant community should consider whether merely ensuring formal equality of
305 opportunity is sufficient, or whether it is necessary but insufficient to achieve the goals of promoting
306 equitable access to transplantation for all persons of similar need.
307 Although many of these factors are structural concerns embedded in the fabric of society and beyond
308 the scope of the transplant community to fix entirely, the transplant community should not be
309 dissuaded from making improvements towards improving distributive justice, even if greater,
310 harmonized efforts are needed to achieve the systemic improvements desired at the public health
311 level.
312 Autonomy
313 The concept of respect for autonomy holds that actions or practices tend to be ethical insofar as they
314 respect or reflect the exercise of self-determination as long as the decisions do not impose harm to
315 others. 112 113 We consider implications of autonomy for multiple listing. 114
316 Ensuring that patients can select the transplant program that best meets their needs is paramount to
317 preserving patient autonomy and may help negate the need for multiple listing. Importantly, this ability
318 is preserved when patients are able to select a transplant program that aligns with their preferences,
111 This sentiment has been shared anecdotally during subcommittee discussions. While there is not literature to substantiate
this comment, it highlights a variation in how patients are informed.
112 OPTN Ethics Committee, Ethical Principles in the Allocation of Human Organs, June 2015, accessed November 18, 2022,
https://optn.transplant.hrsa.gov/professionals/by-topic/ethical-considerations/ethical-principles-in-the-allocation-of-human-
organs/.
113 Ibid.
114 Sanjay Kulkarni and Keren Ladin, “Leveling-up versus leveling-down to address health disparities in transplantation,”
American Journal of Transplantation 21, 3 (Mar 2021): 917-918. https://doi.org/10.1111/ajt.16458.
24 Briefing Paper
C.Agnello SE 0501
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 505 of 569 PageID #:
699
319 and meets their needs in terms of approach, location, cost, support programs, et cetera. For patients to
320 truly realize this opportunity, there must be transparent and accessible information about transplant
321 programs that would allow patients to seek care at the program that is most appropriate for them. 115
322 As the definition of autonomy holds that an action is right insofar as it does not impose undue burden to
323 others, the principle of autonomy raises some concerns with the practice of multiple listing, especially if
324 it is not equally available to all. Optimizing multiple listing for patients who disproportionately need this
325 option owing to their difficulty to benefit from the existing system, would uphold autonomy.
326 Application of Autonomy to Multiple Listing
327 When analyzing multiple listing, autonomy is exhibited in a challenging dichotomy wherein patients,
328 transplant programs, and insurance providers can exercise autonomy in a way that infringes on the
329 autonomy of others. At the center of these considerations are the patients who are informed at
330 evaluation that they are eligible to pursue multiple listing. 116 In theory, this should allow patients the
331 independence to determine what is in their best interest and consider whether to pursue multiple
332 listing. Realistically, patients face a litany of barriers to accessing transplant that can explicitly impact
333 their ability to pursue listing at a secondary or tertiary transplant program. 117 In an effort to overcome
334 barriers to access, shared decision-making between transplant programs and patients could be better
335 utilized to inform and empower patients to exercise their autonomy and determine if they would like to
336 pursue multiple listing. 118
337 However, patients who have decided to pursue multiple listing face additional obstacles in their quest.
338 Policy allows transplant programs to determine if they will accept candidates with multiple registrations
339 or allow candidates to transfer wait time to their transplant program. 119 Thus, a patient may determine
340 they want to pursue multiple listing, but both their current program and their intended program may
341 limit their ability to do so. If the patient’s primary listing program permits them to pursue multiple
342 listings, the patient is still eligible to consider alternative programs. However, their time and other
343 resources may be depleted if they were used at a program that ends up not accepting the patient as a
344 secondary listing. If the patient’s primary listing program does not permit them to pursue multiple
345 listings, then the patient’s autonomy is overruled in favor of the transplant program. In both instances,
346 patient autonomy is infringed upon, yet the latter can place total limitations on the patient’s choice to
347 be multiple listed.
348 Lastly, patients are beholden to the decision of their insurance provider to enable them to pursue
349 multiple listing. In some instances, insurance providers will only cover care when performed by certain
350 institutions, such as Centers of Excellence, which limit patient choice and restrict patient autonomy. 120
351 In other instances, payers will only cover one transplant evaluation per year thus inhibiting a patient’s
115 OPTN Ethics Committee, Transparency in Program Selection, August 2022,
https://optn.transplant.hrsa.gov/media/05elwuzv/bp_transparency-in-program-selection_ethics.pdf.
116 OPTN Policy 3.2.
117 Teri Browne et al., “Everybody needs a cheerleader to get a kidney transplant: a qualitative study of the patient barriers and
facilitators to kidney transplantation in the Southeastern United States,” BMC Nephrology 17, 208 (July 2016).
https://doi.org/10.1186/s12882-016-0326-3.; George Cholankeril et al., “Trends in Liver Transplantation Multiple Listing
Practices Associated With Disparities in Donor Availability: An Endless Pursuit to Implement the Final Rule,” Gastroenterology
151, 3 (Sept 2016): 382-386. https://doi.org/10.1053/j.gastro.2016.07.026.
118 Elisa J. Gordon et al., “Opportunities for Shared Decision Making in Kidney Transplantation,” American Journal of
Transplantation 13, 5 (May 2013): 1149-1158. https://doi.org/10.1111/ajt.12195.; OPTN Ethics, Transparency.
119 OPTN Policy 3.2 and 3.4.F.
120 Roger W. Evans, “Public and Private Insurer Designation of Transplantation Programs,” Transplantation 53, 5 (May 1992):
1041-1046.
25 Briefing Paper
C.Agnello SE 0502
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 506 of 569 PageID #:
700
352 ability to make decisions that align with their preferences and priorities. 121 Worst case, patients in need
353 of organ transplantation may never have the opportunity to exercise their autonomy if they are
354 uninsured and unable to access transplantation. 122
355 In considering the overlapping complexities associated with a patient’s successful secondary waitlist
356 registration, transplant programs and insurance providers should not be the limiting factor for patients
357 to pursue life-saving organ transplantation. While autonomy exists individually between the three actors
358 described above, patient autonomy ought not to be overshadowed by program or payer preferences.
359 Utility
360 Utility could be positively impacted if patients are able to be transplanted expediently or if an increased
361 number of transplants occur (e.g. if multiple listed patients accept more marginal organ offers), but
362 there are currently insufficient data to establish this. There are important tradeoffs to consider. Clinical
363 continuity was originally developed as a concept to include a patient’s primary care team in all relevant
364 medical decisions impacting care delivery. 123,124 Pre-transplant care is a complex, multilevel process that
365 requires coordinated communication to optimize patient care. For example, a patient listed for kidney
366 transplantation accesses care through their dialysis units, primary care provider, specialty referrals such
367 as cardiology, and the transplant program. It is evident that care coordination between these
368 stakeholders is not optimal at baseline and there are several proposed care and reimbursement models
369 to improve care coordination of the pre-transplant kidney patient. 125 The challenge of clinical continuity
370 and care coordination is clearly increased by multiple listing, where several of the key elements
371 providing pre-transplant care are susceptible to fracture by geography, differing care pathways, and
372 suboptimal communication. If a waitlisted patient experiences an ER visit for chest pain, it is unclear if
373 this will effectively be communicated to all transplant programs at which they are listed. By negatively
374 impacting clinical continuity, the ability for patients to receive optimum care can decrease as their care
375 is managed in a disjointed way.
376 Multiple listing can provide challenges for transplant programs as their list management strategies focus
377 on patient preparedness to accept an organ for transplantation. In circumstances where a listed patient
378 may choose to list at multiple transplant programs, the patient may be subject to different testing
379 requirements, waitlist clinical pathways, and potential duplicate testing. These factors have the
380 potential to increase costs prior to transplant, causing the patient, transplant program, and payer to all
381 incur a cost thus increasing the overall healthcare cost.
382 Because organ transplantation is a zero-sum situation, increasing the chances of any given patient by
383 allowing them multiple chances in different regions by definition decreases the relative chances of
384 another patient in the regions in which they list, yet it improves the chances of a patient in the region
385 they left.
121 Rachel E. Patzer et al., “A population Health Approach to Transplant Access: Challenging the Status Quo,” American Journal
of Kidney Disease 80, 3 (Feb 2022): 406-415. https://doi.org/ 10.1053/j.ajkd.2022.01.422.
122 Andrew A. Herring, Steffie Woolhandler, and David U. Himmelstein, “Insurance Status of U.S. Organ Donors and Transplant
Recipients: The Uninsured Give, but Rarely Receive,” International Journal of Health Services 38, 4 (Oct 2008): 641-652.
https://doi.org/10.2190/HS.38.4.d.
123 Michael D. Cabana and Sandra H. Jee, “Does continuity of care improve patient outcomes?” Journal of Family Practice 53, 12
(Dec 2004): 974-980.
124 Martin Gulliford, Smriti Naithani, and Myfanwy Morgan, “What is ‘continuity of care’?” Journal of Health Services Research &
Policy 11, 4 (Oct 2006). https://doi.org/10.1258/135581906778476490.
125 Marie Dirix et al., “Timing of the pre-transplant workup for renal transplantation: is there room for improvement?” Clinical
Kidney Journal 15, 6 (Jan 2022): 1100-1108. https:/doi.org/10.1093/ckj/sfac006.
26 Briefing Paper
C.Agnello SE 0503
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 507 of 569 PageID #:
701
386 On par, the principle of utility is inconclusive and highlights a number of considerations related to
387 multiple listing, including systemic concerns related to efficiency. Although sometimes in tension, in this
388 case, the principles of equity and utility both suggest that multiple listing, if broadly used, would violate
389 the basic premises of justice and efficiency. However, using multiple listing to address the
390 disproportionate needs of potentially underserved groups would allow both equity and utility to occur.
391 Data Analysis Pertaining to Utility in Multiple Listing
392 While multiple listing may appeal to patients with the possibility of decreased time to transplant, OPTN
393 data found that multiple listed kidney and liver recipients had a higher median waiting time when
394 compared to single listed kidney and liver recipients. 126 Despite the benefits of early transplant
395 described above, it is not clearly shown that multiple listing leads to a decreased time on the waitlist. It
396 is possible that the increased wait time accounts for patients who are hard to match or pre-sensitized;
397 however, additional research is needed to establish those conclusions.
398 OPTN data found that most often patients are multiple listed at locations that are within driving
399 distance of their home. However, kidney candidates who listed closer to home (under 250 nautical
400 miles) were less likely to be benefit from multiple listing compared to those listing outside of the 250
401 NM range. 127 This finding expands upon prior literature, and differs by analyzing the role of multiple
402 listing within the same acuity circle as the primary listing program. 128,129,130,131 For kidney transplant
403 candidates, 77% of the secondary listing programs were located within 250 nautical miles, the initial
404 acuity circle used to allocate kidneys, of the primary transplant program, compared to 52% of multiple
405 listed liver candidates who pursued their secondary listing at a program that was within 150 nautical
406 miles, the initial acuity circle used to allocate livers, from the primary transplant program. 132
407 While the close proximity of the secondary listing program makes the case for increased access to
408 multiple listing, the close proximity calls into question what the added benefit of multiple listing may be.
409 The current allocation framework prioritizes patients within a given nautical mile radius and by only
410 minimally expanding the radius one is eligible to receive offers from, the benefit of multiple listing is
411 likely reduced. The practice of multiple listing inside the initial circle suggests that some of the benefits
412 may be more attributable to program practices such as offer acceptance patterns rather than
413 geographic differences in donor availability.
414 Since acuity circles are a relatively newer allocation model, multiple listing within acuity circles has not
415 been reviewed, thus this analysis differs from contemporary literature, which considers instances of a
416 patient pursuing secondary listing outside of their primary transplant program’s acuity circle. 133 The
417 Committee hypothesized that the prevalence of patients multiple listed close to their primary listing
418 program is likely a lingering result of the transition from allocating within donor service areas (DSAs) to
419 acuity circles.
126 Gauntt, “Data Request,” September 14, 2022.
127 Gauntt, “Data Request,” September 9, 2022.
128 Sara Brown et al., “Multiple Regional Listing Increases Liver Transplant Rates for Those With Model for End-stage Liver
Disease Score <15,” Transplantation 104, 4 (Apr 2020):762-769. https://doi.org/10.1097/TP.0000000000002965.
129 Decoteau, “The Advantage,” 2021.
130 Zahara Gharibi and Michael Hahsler, “A Simulation-Based Optimization Model to Study the Impact of Multiple-Region Listing
and Information Sharing on Kidney Transplant Outcomes,” International Journal of Environmental Research and Public Health
18, 873 (Jan 2021). https://doi.org/10.3390/ijerph18030873.
131 Appendix A, Figures 1-3 Distances Between Primary and Secondary Listing Transplant Hospitals for Multiple Listed Kidney,
Liver, and Thoracic Candidates on December 31, 2021.
132 Bradbrook, “Data Request,” May 11, 2022
133 Decoteau et al., “The Advantage.”
27 Briefing Paper
C.Agnello SE 0504
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 508 of 569 PageID #:
702
420 Additionally, recent allocation changes impact transplant wait times with differences noted between
421 organs. Kidney allocation changed from DSA to acuity circles and has seen a decrease in kidney multiple
422 listings, while liver patients experienced the inverse. 134 However, it is important to note that the sample
423 size for multiple listed liver patients was much smaller than kidney patients and covered a shorter length
424 of time since the transition from DSA to acuity circles. Additionally, due to the difference in wait time
425 between kidney and liver patients, it may be fair to assume that the proportion of liver patients seeking
426 multiple listing has not increased, but the liver patients who had multiple listed prior to the change in
427 allocation were transplanted. The overall trend after allocation change from DSAs to acuity circles was a
428 net decline in organ multiple listings. 135
429 Lastly, the myriad of regional variation in transplant rates for patients who are multiple listed cannot be
430 clearly captured in the data analysis but requires consideration. Potential contributors to regional
431 variation include density and practices of organ procurement organizations (OPOs) and transplant
432 programs, regional practice differences (regional practice of splitting livers), population density,
433 population health, and attitudes towards transplant. 136,137 These factors, some of which are not clearly
434 known by patients seeking transplant, can lead to longer wait times based on transplant center
435 selection. As such, multiple listing could help to correct disparities caused by differences in program
436 practices that may inadvertently lengthen a patient’s time to transplant. Examples of program practices
437 that affect wait time include offer acceptance patterns, such as DCD organ utilization, HCV positive
438 organ utilization, and pulsatile preservation utilization to maximize transplantable organs.
439 Conclusions
440 Multiple listing has an extensive history in transplant policy, but not without controversy both within the
441 transplant community and in the public at large. Any future project to revise this longstanding policy
442 would require significant empirical analysis to review utilization patterns, as well as ethical analysis to
443 inform whether the policy is justified, given the patient access and usage. It is with humility,
444 compassion, and a commitment to uphold the goals of the OPTN that the Committee approaches the
445 ethical analysis of multiple listing. Because transplant is a zero-sum system, our analysis provides
446 concerning evidence about the legitimacy of being able to simultaneously receive multiple organ offers
447 for some people, while others in the same system are unable to exercise that benefit.
448 Data analyzed for this paper demonstrates a nuanced picture, one of existing disparities by payer,
449 education, and race/ethnicity, mirroring existing disparities in health access and a less clear picture by
450 geocoded level income and poverty level. Moreover, removing the practice of multiple listing overall
451 may resolve some disparities, but could exacerbate others, particularly for patients with medical
452 complexity, those who are already sensitized to potential donors, or otherwise difficult to match; also,
453 for pediatric candidates and candidates who list at VA hospitals. Although multiple listing is narrowly
454 utilized, in the context of the transplant community’s commitment to equity, policies governing access
455 to transplantation should ensure and promote the transplant community’s commitment to equitable
134 Gauntt, “Data Request,” September 14, 2022.
135 Ibid.
136 Kristen L. King et al., “Major Variation across Local Transplant Centers in Probability of Kidney Transplant for Wait-Listed
Patients,” Journal of the American Society of Nephrology 31, 20 (Dec 2020): 2900-2911.
https://doi.org/10.1681/ASN.2020030335.
137 George Cholankeril et al., “Disparities in Liver Transplantation Resulting From Variations in Regional Donor Supply and
Multiple Listing Practices,” Clinical Gastroenterology and Hepatology 15, 2 (Feb 2017): 313-315.
https://doi.org/10.1016/j.cgh.2016.08.036.
28 Briefing Paper
C.Agnello SE 0505
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 509 of 569 PageID #:
703
456 access to care. Although the transplant community cannot resolve all public health disparities, it must
457 strongly consider revising policies that entrench them and continue efforts to rectify these.
458 Ethical principles, including equity and utility, validate concerns over the widespread use of multiple
459 listing, however, they uphold the import of multiple listing in certain cases, including patients who are
460 difficult to match. As such, multiple listing should be retained and used to increase equitable access to
461 transplantation for patients that are difficult to match.
462 The Committee notes that multiple listing is different from multiple evaluation, wherein a patient can be
463 evaluated at multiple programs if they are dissatisfied with their treatment at a given program at any
464 time. Increased transparency at the outset would help minimize patients selecting programs that do not
465 align with their goals.
466 The transplant community cannot by itself resolve the socioeconomic factors that contribute to inequity
467 in healthcare. While true, this fact does not absolve the community from remediating the policies that
468 exacerbate disparities within transplantation that are consistent with social patterning of privilege.
469 The ethical analysis of multiple listing strongly supports the use of this policy for patients that are
470 difficult to match, pediatric candidates and candidates who list at VA hospitals. The Committee also
471 recognizes that the multiple listing policy is valued by many, and many centers and patients are
472 accustomed to having this option. Although recommendations are beyond the scope of this analysis,
473 greater efforts ensuring that all patients are informed of this option and have the ability to exercise
474 are crucial to ensuring that it promotes the goals of the OPTN. These may include improving patient-
475 centered education about multiple listing; financial support such as scholarships or other resources to
476 support multiple listing for patients in need where possible; prohibiting programs from refusing multiple
477 listed patients; and increasing transparency in evaluation, listing, and organ acceptance practices to help
478 patients choose a primary program that best fits their needs.
29 Briefing Paper
C.Agnello SE 0506
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 510 of 569 PageID #:
704
Appendix A: Data Requests
479 Appendix A details the methods of the two data requests performed at request of the Ethics
480 Committee. 138, 139
481 Methods – 1st Data Request
482 The first data request borrowed the definition of multiple listing used in the Decoteau et al. article. 140
483 Multiple listing was defined as any candidate who is on the transplant waitlist for a particular organ at
484 more than one program simultaneously. A candidate was be considered multiple listed regardless of the
485 time between first listing and subsequent listing. In this way, the multiple listing definition captured all
486 candidates who both intended to multiple lists from the outset and those who for whatever reason
487 made the decision further into their waitlist tenure (potentially due to frustration or inability to secure a
488 quality offer). All of the following metrics were be calculated based on a recent snapshot of candidates
489 waiting on the heart, liver, lung and kidney waitlist as of December 31, 2021. All metrics were presented
490 by organ type (kidney, liver, and thoracic – heart and lung were combined due to small sample size) and
491 compare multiple listed and single listed candidates, unless otherwise stated. Note that candidates
492 could have been listed for multiple organs. Candidates, for example, who were listed for a heart and
493 kidney appeared in both the heart and kidney counts but are only counted once in overall totals.
494 Candidate Demographics: The following candidate demographics are summarized by organ type for
495 multiple and single listed candidates:
496 • Age at snapshot date (years)
497 • Race/Ethnicity (American Indian or Alaska Native, Black or African American, Native Hawaiian or
498 other Pacific Islander, Asian, Hispanic or Latino, White)
499 • Insurance Status (private/public) at registration
500 • Education level (None, Grade School or less, High School or GED, College or Technical, Associate
501 or Bachelor Degree, Post-College Graduate Degree)
502 • Blood Type (AB, A, B, O)
503 • MELD/PELD (Liver Only)
504 • Heart Status (Heart Only)
505 • LAS (Lung Only)
506 • Medically Urgent (Kidney Only)
507 • Annual Household Income* (based on candidate zip code and using census data)
508 • Annual Household Income* by Insurance level
509 • Poverty Percent (based on candidate zip code and using census data)
510 • Region (11 OPTN regions)
511 Note: The committee expressed interest in looking at indicators of socioeconomic status and correlates
512 of social determinants of health, such as annual household income. In order to do this OPTN data was
513 linked to Census data via candidate’s primary zip code at listing, which was found on the transplant
514 candidate registration (TCR) form. It is important to note that there are several limitations in the use of
138 Keighly Bradbrook, Katrina Gauntt, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Candidates By Organ
Type,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee, May 11, 2022.
139 Katrina Gauntt, Keighly Bradbrook, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Kidney and Liver
Candidates by Geography,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee,
September 14, 2022.
140 Mary A. Decoteau et al., ‘The Advantage of Multiple Listing Continues in the Kidney Allocation System Era,” Transplantation
Proceedings 53, 2 (Mar 2021): 569-580. https://doi.org/10.1016/j.transproceed.2020.10.036.
30 Briefing Paper
C.Agnello SE 0507
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 511 of 569 PageID #:
705
515 candidate zip codes from OPTN data and the usage of environment level factors like annual household
516 income in describing patient level determinants of health. Candidate zip codes are not validated in OPTN
517 data and so data entry problems are likely to exist, and the linkage is not perfect and can often result in
518 zip codes that do not link to census data. Further, research shows that family income or annual
519 household income at the aggregated geography level (county, state) are not always good descriptors of
520 an individual’s access, situation, or barriers. Often, for individuals who may be better off than what the
521 aggregated data would suggest, their own personal situation attenuates any disadvantage that might be
522 conferred by their environment.
523 Poverty percent is the percent of people living in poverty within a ZCTA within a year (zip code
524 tabulation areas) and is based on the Census data.
525 Demographics were summarized as count and percent for categorical variables and mean and standard
526 deviation for continuous covariates, in tabular form. Distributions of candidate characteristics were
527 plotted by organ type.
528 Metrics for Multiple listed candidates only: The subcommittee was also interested in describing
529 characteristics of multiple listed candidates at the time of first multiple listing. The following metrics
530 describe the distribution of time between primary listing and secondary listing where primary listing is
531 defined as the first registration to occur in time and secondary listings those occurring after the primary
532 (i.e. the second, third, fourth or fifth listing locations). Only first and secondary listings were considered.
533 The following metrics were calculated using a subset of multiple listed candidates from December 31,
534 2021, snapshot data by organ type:
535 • Distribution of age, medical urgency status and hospitalization at secondary listing
536 • Distribution of time between initial listing and secondary listing for multiple listed candidates
537 • Distance from primary transplant program to secondary (or additional transplant programs)
538 These metrics will be presented in tabular form as min, max, median, mean and IQR and graphed.
539 Geography: The subcommittee was also interested in looking at the geography of multiple listings. All
540 secondary listings were included in these analyses. Results were de-identified with regard to transplant
541 program. The following metrics were calculated using a subset of multiple listed candidates from the
542 December 31, 2021, snapshot data by organ type:
543 • The percent of multiple listed candidates at each program – do a majority of multiple listings
544 occur at a handful of programs?
545 • Percent of multiple listings by state and OPTN region (based on transplant program location, not
546 candidate location)
547 Methods – 2nd Data Request
548 Methods
549 Similar to the first data request, this follow-up request borrowed the definition of multiple listing used in
550 the Decoteau et al. article. Multiple listing was defined as any candidate who is on the transplant waitlist
551 for a particular organ at more than one program simultaneously. A candidate was considered multiple
552 listed regardless of the time between first listing and subsequent listing. In this way, the multiple listing
553 definition captured all candidates who both intended to multiple lists from the outset and those who for
554 whatever reason made the decision further into their waitlist tenure (potentially due to frustration or
555 inability to secure a quality offer). All of the following metrics were calculated based on waitlist data. A
556 recent snapshot of candidates waiting on December 31, 2021, was used for all metrics with the
31 Briefing Paper
C.Agnello SE 0508
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 512 of 569 PageID #:
706
557 exception of transplant rates. The metrics focused on liver and kidney candidates unless otherwise
558 stated. Thoracic was excluded at the request of the subcommittee.
559 The committee requested the median time to transplant by listing status, due to limitations in data the
560 median time to transplant could only be provided for those that had received a transplant. In order to
561 provide more insight to the question of equity in access the workgroup sought to evaluate, the
562 transplant rate was provided calculated as transplant per 100 inactive and active patient-years. The
563 transplant rates were calculated based on an ever-waiting cohort from implementation of acuity circles
564 to March 31, 2022. For liver this was candidates ever waiting 141 between February 4th, 2020, to March
565 31, 2022, and for kidney this was candidates ever waiting between March 15, 2021 to March 31st, 2022.
566 Candidates were indicated as ever multiple listed if at any point in the cohort time frame the candidate
567 had two or more listings at multiple programs that overlapped. Candidate waiting time was considered
568 by taking the time in days from the first listing date to either the date of transplant or the date of
569 candidate removal from all listings from the waitlist, including both active and inactive waiting time for
570 the candidate.
571 Additional Metrics
572 • Number/percent of candidates listed (primary listing) before the removal of DSA policy on
573 March 15, 2021, by organ type
574 • Number/percent of Kidney and Liver multiple listed candidates whose (first) secondary listing
575 was outside of the DSA from primary listing
576 • Number/percent of Kidney and Liver multiple listed candidates whose (first) secondary listing
577 was outside of the priority circle (250NM for Kidney and 150 NM for Liver)
578 • Number/percent of Kidney and Liver multiple listed candidates who had any secondary listing
579 outside of the DSA from primary listing
580 • Number/percent of Kidney and Liver multiple listed candidates who had any secondary listing
581 outside of the priority circle (250NM for Kidney and 150 NM for Liver)
582 • Transplant rate per 100 patient-years by multiple listing status, geography (pending sample
583 size), and multiple listing and geography for Kidney and Liver candidates, separately
584
141 “Ever waiting” is inclusive of candidates who spent any time waiting during the time period described - whether
the candidate was on the waiting list the entire time period or a shorter subset
32 Briefing Paper
C.Agnello SE 0509
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 513 of 569 PageID #:
707
585 Table 1
33 Briefing Paper
C.Agnello SE 0510
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 514 of 569 PageID #:
708
586 Figure 1
587 Figure 1, below, shows the distribution in nautical miles (NM) between first listing hospital and second
588 listing hospital for multiple listed kidney candidates. The media distance between listing hospitals for
589 kidney candidates that multiple listed was 89 NM.
590
591 Figure 1. Distance Between Primary and Secondary Listing Transplant Hospitals for Multiple Listed
592 Kidney Candidates on December 31, 2021
593
594
595
596 *There were 193 Multiple Listed candidates that had secondary regiatrations at a transplant hospital that
597 exceeded 1,250 NM in distance from the hospital they were primarily listed at.
598
599 The red line shows the median distance from primary to secondary listing.
600
Candidates Minimum 25th-Quantile Mean Median 75th-Quantile Maximum
6525 0 32 213.65 89 199 4186
601
34 Briefing Paper
C.Agnello SE 0511
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 515 of 569 PageID #:
709
602 Figure 2
603 Figure 2, below, shows the distribution in nautical miles (NM) between first listing hospital and second
604 listing hospital for multiple listed liver candidates. The media distance between listing hospitals for liver
605 candidates that multiple listed was 103.5 NM.
606
607 Figure 2. Distance Between Primary and Secondary Listing Transplant Hospitals for Multiple Listed
608 Liver Candidates on December 31, 2021
609
610 *There were 10 Multiple Listed candidates that had secondary regiatrations at a transplant hospital that
611 exceeded 1,250 NM in distance from the hospital they were primarily listed at.
612
613 The red line shows the median distance from primary to secondary listing.
614
Candidates Minimum 25th-Quantile Mean Median 75th-Quantile Maximum
176 0 29 300.77 103.5 362.5 3378
615
35 Briefing Paper
C.Agnello SE 0512
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 516 of 569 PageID #:
710
616 Figure 3
617 Figure 2, below, shows the distribution in nautical miles (NM) between first listing hospital and second
618 listing hospital for multiple listed thoracic candidates. The media distance between listing hospitals for
619 liver candidates that multiple listed was 161 NM.
620
621 Figure 3. Distance Between Primary and Secondary Listing Transplant Hospitals for Multiple Listed
622 Thoracic Candidates on December 31, 2021
623
624 *A single Multiple Listed candidate that had a secondary regiatrations at a transplant hospital that
625 exceeded 1,250 NM in distance from the hospital they were primarily listed at.
626
627 The red line shows the median distance from primary to secondary listing.
628
Candidates Minimum 25th-Quantile Mean Median 75th-Quantile Maximum
37 11 75 300.86 161 273 2129
629
36 Briefing Paper
C.Agnello SE 0513
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 517 of 569 PageID #:
711
630 Figure 4
631 Figure 4 shows the transplant rate by listing status and secondary listing location for both kidney and
632 liver candidates every waiting from circle allocation implementation to March 31, 2022 broken out by
633 organ. For kidney, singly listed candidates had a lower transplant rate than both of the multiple listing
634 categories, with multiple listed outside of the circle having the highest transplant rate. Single listed
635 kidney candidates had a transplant rate of 20.01 per 100 patient-years vs. 30.07 per 100-patient years
636 for multiple listed kidney candidates inside of the circle and 36.01 per 100 patient-years for multiple
637 listed kidney candidates outside of the circle. For liver, multiple listed liver candidates outside of the
638 circle had the lowest transplant rate at 57.27 transplants per 100 patient-years, and multiple listed liver
639 candidates inside of the circle had the highest transplant rate at 95.24 transplants per 100 patient-years.
640
641 Figure 4. Transplant Rate by Listing Status and Secondary Listing Location for Kidney and Liver
642 Candidates Ever Waiting from Circle Allocation Implementation by Organ to March 31, 2022
643
644
37 Briefing Paper
C.Agnello SE 0514
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 518 of 569 PageID #:
712
645 Table 2
646 Table 2. Transplant Rate by Listing Status for Kidney and Liver Candidates Ever Waiting from Circle
647 Allocation Implementation by Organ to March 31, 2022
38 Briefing Paper
C.Agnello SE 0515
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 519 of 569 PageID #:
713
Addendum to “Ethical Evaluation of Multiple Listing: A
Comprehensive Response to Public Comment”
648 Public Comment Overview
649 The Ethics Committee deeply values feedback shared during the public comment period, which exists in
650 service of giving stakeholders in the transplantation community the opportunity to share their
651 perspectives. In response, the committee offers this addendum to “Ethical Evaluation of Multiple
652 Listing” in hopes of responding thoughtfully and thoroughly to the well-taken objections that have been
653 shared with us.
654
655 The Ethics Committee would first like to note that the public comment period revealed that overall,
656 there was considerable support for the white paper, and in particular for its attempt to uphold an
657 equitable and efficient system of organ allocation. This support was displayed even by members who
658 raised concerns. Indeed, many in public comment acknowledged that candidates who multiply list tend
659 to be individuals of more means, education, and resources with which to travel, having family, friends,
660 and other forms of support in more than one geographic region that make them more likely to receive a
661 transplantation than others on the waiting list who lack these resources.
662
663 This noted, there were seven general categories of criticism the Ethics Committee felt merited focused
664 responses. These include: (1) The white paper singles out organ transplantation as inequitable, but our
665 whole healthcare system suffers from inequity, something we will not solve simply by calling attention
666 to organ allocation policy. Why, then, single out inequity in organ allocation in this particular instance?
667 (2) Despite equity concerns, doesn’t the principle of autonomy provide a larger justification for the
668 practice of multiple listing? (3) An ethic of care not only permits, but also requires, us to do every and
669 anything in our power to help our loved ones who are desperate for a bodily organ. Should not anybody
670 similarly circumstanced do whatever they could to help find their loved ones the organ they needed? (4)
671 Does the effort to undo the practice of multiple listing sufficiently take into account the logistical
672 realities of transplantation in different regions of the country? (5) The Ethics Committee supports the
673 practice of multiple listing in the case of difficult to match patients, but how does it propose to establish
674 thresholds which separate difficult to match patients? And (6) is the Ethics Committee acting within its
675 scope?
676
677 The Ethics Committee is grateful for the opportunity to respond to each of these thoughtful objections.
678
679 (1) We are not likely to fix disparities in the whole healthcare system. Why should we focus
680 exclusively on one practice, multiple listing, within one facet of healthcare, organ
681 transplantation? And why problematize multiple listing while still allowing for multiple
682 evaluations?
683
684 The Ethics Committee acknowledges that there is no shortage of examples of inequitable treatment in
685 the United States, where those with means experience disproportionate benefit and access to care.
686 However, that a large system is problematic doesn’t alleviate the burden of trying to fix some part of it.
687 In focusing on the practice of multiple listing, the Ethics Committee examined what was proposed to be
688 the legitimate rationale for this policy, and to question, if that rationale could not be clearly identified,
39 Briefing Paper
C.Agnello SE 0516
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 520 of 569 PageID #:
714
689 whether it could continue to be supported. Thus, the Ethics Committee did not seek to “single out” the
690 practice of multiple listing for attention. The Committee reviews all policies to assess their ethical
691 implications and how they balance ethical principles underpinning the organ transplant system. The
692 multiple listing policy has been scrutinized for many years and has never undergone ethical analysis. As
693 such, this was a priority for the OPTN and the Committee.
694
695 Under the assumption that organ transplantation is zero-sum, when it comes to those on the waiting
696 list, if one person receives an organ, then that is one organ another does not receive. Ensuring fairness
697 as a value in itself, and also promoting the utility end of preserving the perception of fairness of the
698 transplant system is imperative. For these reasons, the Ethics Committee felt that our attention to
699 decreasing disparities in multiple listing was worth our attention and effort, particularly in light of the
700 recently issued National Academies of Sciences, Engineering and Medicine (NASEM) report which
701 instructs all stakeholders in the transplantation community to try to make organ allocation more
702 equitable. 142
703
704 Some members additionally raised the issue that by calling attention to the practice of multiple listing,
705 but not multiple evaluation, we were essentially deferring the problem of inequity within
706 transplantation, not solving it. In response, the Ethics Committee notes, as described in the
707 “Transparency” white paper, seeking evaluations at multiple centers supports patient-centered care and
708 autonomy, without negatively impacting others. In contrast, when one multiply lists, at that moment in
709 time one becomes the beneficiary of having more than one avenue towards transplantation, accruing an
710 advantage well beyond determining what transplant center represents the right fit.
711
712 (2) Why would the Ethics Committee try to curtail patient autonomy, which would seem to
713 permit multiple listing?
714
715 Autonomy is a critical principle in medical ethics, and in transplantation ethics specifically, but autonomy
716 is not an absolute right, absolved from the burden of being placed in balance with other ethical
717 principles. In addition, a tacit but indispensable constraint on the autonomy of one person is that it can’t
718 lead to the curtailment of the autonomy (and flourishing) of another. But retaining a policy of multiple
719 listing across the board would do just this. In specific, it would curtail the autonomy of marginalized and
720 structurally disadvantaged individuals among us. Lower levels of insurance, education, and at times
721 race/ethnicity (particularly in the case of liver) limit access to transplant. Since it is also true that
722 multiple listing is associated with higher likelihood of transplant, in the status quo the privileged would
723 be gaining an advantage at the expense of the underprivileged.
724
725 Currently, multiple listing is not a practice that all patients are able to exercise or utilize. The use of
726 multiple listing is patterned in a way that exacerbates existing disparities in access to transplant and
727 healthcare. For example, patients with less than a high school education are 50% less likely to be
728 multiple listed for a kidney or liver transplant, while those with a post-college graduate degree are 60%
729 more likely to be multiple listed for liver and kidney transplant. Patients with Medicaid are at least three
730 times less likely to be multiple listed than those with private insurance for kidney and liver transplant. 143
731
142 National Research Council. 2022. Realizing the Promise of Equity in the Organ Transplantation System. Washington, DC: The
National Academies Press. https://doi.org/10.17226/26364.
143 Katrina Gauntt, Keighly Bradbrook, and Jesse Howell, “Data Request – Characteristics of Multiple Listed Kidney and Liver
Candidates by Geography,” OPTN, Descriptive Data Request for the Ethics Committee Multiple Listing Subcommittee,
September 14, 2022.
40 Briefing Paper
C.Agnello SE 0517
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 521 of 569 PageID #:
715
732 Limiting multiple listing would reduce an advantage that aligns with socioeconomic disparities in access
733 to transplant, thereby creating more of a level playing field with regard to ensuring everyone’s ability to
734 exercise their autonomy. This calls attention to one of the ways in which organ transplantation is
735 perhaps distinctive, for unlike other areas of healthcare, as mentioned above, transplant is a zero-sum
736 game. When one patient is able to accept an organ offer from multiple centers simultaneously, another
737 patient’s likelihood to receive an organ decreases. In this respect, the Ethics Committee sees itself in the
738 end as upholding the principle of autonomy, despite that an analysis undertaken without taking into
739 account social disparities might lead one to draw the opposite conclusion.
740
741 (3) Why would the Ethics Committee get in the way of individuals doing whatever they can to
742 help the ones they love? Shouldn’t we support policies that defend the loving impulses of the
743 families of those in desperate situations?
744
745 The Ethics Committee acknowledges and has a great deal of sympathy for this objection, which is
746 compelling because we can all imagine how we would feel if we were in the shoes of one, or those of a
747 family member of one, who needed an organ. In responding, it is critical to make a distinction between
748 the perspective from the ethics of care, which operates at the level of the individual, and the ethics of
749 systems of allocation, which must always consider justice at the population-level. The Ethics Committee
750 acknowledges explicitly in our white paper that on an individual level the current policy on multiple
751 listing can open up a precious extra option for those facing desperate circumstances. However, this
752 individual level of analysis does not easily translate into a policy meant to determine the fair allocation
753 of scarce resources, which by definition is a public enterprise. There are many actions (e.g. paying for
754 organs) that, although they may promote the benefit of an individual in pursuing an organ transplant,
755 are not permissible at the population/societal-level.
756
757 (4) Does the Ethics Committee’s attention to the practice of multiple listing fully capture the
758 logistical realities of transplantation in different regions of the country, and does it cohere
759 with concurrent initiatives underway of Continuous Distribution?
760
761 Some present a compelling objection by stating that multiple listing solves a larger disparity in organ
762 transplantation by shifting patients from areas with long waitlists to areas with shorter waitlists. They
763 acknowledge that, while this may lengthen the waitlist in areas where patients are secondarily listed, it
764 relieves the burden from regions disproportionately experiencing long waits. Moreover, they note that
765 allowing patients to retain their primary listing, which is most commonly near their primary residence,
766 allows patients to keep relationships with transplant teams, which patients and centers value highly.
767
768 The Committee acknowledges that use of multiple listing as a workaround to smooth differences in
769 waiting times is appealing and understandable at the individual level. However, the Committee notes
770 that organ allocation policies are created to ensure a balance of ethical principles of utility, justice, and
771 respect for persons for all stakeholders and operate at the health-system level. Geographic differences
772 in waiting times should be resolved by policies governing the system as a whole, including new
773 initiatives to continuous distribution, and not through individual workarounds which are likely to benefit
774 some but not all. Similar to arguments made in the white paper on manipulating waitlist priority,
775 individual-level manipulation of waitlist priority through interventions or multiple listing increases a
776 transplant candidate’s priority on the waitlist relative to others, undermines the legitimacy and balance
777 of ethical principles of the organ allocation system as a whole.
778
41 Briefing Paper
C.Agnello SE 0518
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 522 of 569 PageID #:
716
779 (5) The Ethics Committee supports the ethical justification for multiple listing in the case of
780 difficult to match patients, but how can we distinguish these patients?
781
782 The Ethics Committee is aware that in response to our white paper members seek more specific
783 guidance regarding medically complex or difficult to match patients. What is the definition, some asked,
784 of “medically complex?”
785
786 Our response is that simply in acknowledging that there is a category of prospective organ recipients
787 who are biologically uncommonly difficult to match, we do not at the same time fail to recognize that
788 physicians and other clinical staff at specific transplant centers are the ones best positioned to make the
789 determinations about who falls into this category on a case-by-case basis. By identifying the category of
790 patients who are difficult to match, the Ethics Committee is merely staking out a weaker position than
791 might be suggested in other analyses which recommend the abolishment of the practice of multiple
792 listing altogether. The Ethics Committee leaves it to organ-specific committees and other committees to
793 arrive at standards for what constitutes “difficult to match,” and hopes only that these might be applied
794 consistently and transparently across the board. Significantly, the Ethics Committee acknowledges a
795 qualitative difference between non-medical criteria like privilege and material advantage, which should
796 not bear on one’s place on the waiting list, and sensitization, which arguably should. That the Ethics
797 Committee acknowledges this category as exceptional does not imply that the Ethics Committee sees
798 itself as the adjudicator of eligibility for it.
799
800 (6) Is the Ethics Committee out of scope?
801
802 The concern that the Ethics Committee has somehow veered out of its proverbial lane is one we are
803 pressed to address in different contexts from time to time. We want to emphasize that we serve only in
804 a guidance capacity to transplantation policy. The mission and scope of the Ethics Committee is:
805
806 “The Ethics Committee aims to guide the policies and practices of the OPTN related to organ donation,
807 procurement, distribution, allocation, and transplantation so they are consistent with ethical principles.
808 The Committee makes recommendations to Board of Directors for changing, creating, or eliminating
809 policies if warranted by ethical concerns. The Committee also provides written guidance pertaining to
810 ethical considerations to OPTN members, after approval by the Board of Directors. The Committee does
811 not address individual patient issues or disputes.” 144
812
813 The Ethics Committee leaves it to others to make actionable recommendation that might be inferred
814 from our analysis. The Ethics Committee hopes that stakeholders bear in mind the mandate issued in
815 the NASEM report to improve equity in transplantation policy, which implies improving access for
816 patients to match who have the least means at their disposal. This noted, this white paper does not
817 change the existing policies allowing multiple listing. It reviews the ethical considerations and
818 preliminary data of the practice of multiple listing and undertakes an ethical analysis based on these
819 findings.
#
144 “Ethics Committee." OPTN: Organ Procurement and Transplantation Network - OPTN. Accessed April 7, 2023.
https://optn.transplant.hrsa.gov/about/committees/ethics-committee/. Charter is listed at the top of this webpage.
42 Briefing Paper
C.Agnello SE 0519
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 523 of 569 PageID #:
717
EXHIBIT W
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0520
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 524 of 569 Pag
718
C.Agnello SE 0521
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 525 of 569 Pag
719
C.Agnello SE 0522
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 526 of 569 Pag
720
C.Agnello SE 0523
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 527 of 569 Pag
721
C.Agnello SE 0524
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 528 of 569 Pag
722
C.Agnello SE 0525
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 529 of 569 Pag
723
C.Agnello SE 0526
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 530 of 569 Pag
724
C.Agnello SE 0527
:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 531 of 569 Pag
725
C.Agnello SE 0528
Case 2:24-cr-00366-NJC Document 24-1 Filed 03/11/26 Page 532 of 569 PageID #:
726
EXHIBIT X
Metcalf & Metcalf, P.C.
99 Park Avenue, Suite 810
New York, NY 10016
646.253.0514 (Phone)
646.219.2012 (Fax)
C.Agnello SE 0529
THE MISSING LINK IN GENERAL DETERRENCE RESEARCH*
Gary Kleck; Brion Sever; Spencer Li; Marc Gertz
Criminology; Aug 2005; 43, 3; Criminal Justice Periodicals
NJC
pg. 623 Document 24-1 Filed 03/11/26 Page
727
C.Agnello SE 0530
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
728
C.Agnello SE 0531
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
729
C.Agnello SE 0532
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
730
C.Agnello SE 0533
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
731
C.Agnello SE 0534
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
732
C.Agnello SE 0535
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
733
C.Agnello SE 0536
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
734
C.Agnello SE 0537
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
735
C.Agnello SE 0538
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
736
C.Agnello SE 0539
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
737
C.Agnello SE 0540
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
738
C.Agnello SE 0541
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
739
C.Agnello SE 0542
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
740
C.Agnello SE 0543
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
741
C.Agnello SE 0544
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
742
C.Agnello SE 0545
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
743
C.Agnello SE 0546
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
744
C.Agnello SE 0547
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
745
C.Agnello SE 0548
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
746
C.Agnello SE 0549
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
747
C.Agnello SE 0550
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
748
C.Agnello SE 0551
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
749
C.Agnello SE 0552
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
750
C.Agnello SE 0553
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
751
C.Agnello SE 0554
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
752
C.Agnello SE 0555
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
753
C.Agnello SE 0556
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
754
C.Agnello SE 0557
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
755
C.Agnello SE 0558
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
756
C.Agnello SE 0559
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
757
C.Agnello SE 0560
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
758
C.Agnello SE 0561
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
759
C.Agnello SE 0562
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
760
C.Agnello SE 0563
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
761
C.Agnello SE 0564
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
762
C.Agnello SE 0565
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
NJC Document 24-1 Filed 03/11/26 Page
763
C.Agnello SE 0566
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.File and source
- File
- 24-att1-97f018f5.pdf
- Size
- 37,126,859 bytes
- SHA-256
- 97f018f5f5de186ff812ac07da90187a36368ce1db147313ab4da3ad4da38af5
- Our copy
- 24-att1-97f018f5.pdf