HHS Office of Inspector General Semiannual Report to Congress (April 1, 2024, through September 30, 2024)
Summary
The Office of Inspector General of the Department of Health and Human Services reports to Congress on its work for the 6-month period ending on September 30, 2024, under Inspector General Christi A. Grimm. For April 1, 2024 through September 30, 2024, OIG says its investigative and audit work identified $4.36 billion in expected recoveries and receivables, that it issued 53 audits and 22 evaluations, and that enforcement produced more than 836 civil and criminal actions; for fiscal year 2024 the figure was $7.13 billion. Investigative receivables for the period total $3,936,240,673, and the appendix counts 401 criminal actions resulting from investigations. A case example describes pharmacy owners sentenced in an $18 million COVID-19 health care fraud who used emergency override billing codes to bill for cancer medications that were not prescribed or dispensed.
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Contents
A Message From the Inspector General .................................................................... i
At a Glance: OIG Accomplishments ......................................................................... iii
Introduction .............................................................................................................. 1
1 | Public Health ....................................................................................................... 2
2 | Financial Integrity ................................................................................................ 5
3 | Medicare and Medicaid ...................................................................................... 8
4 | Beneficiary Safety.............................................................................................. 11
5 | Data and Technology Security ........................................................................... 13
Appendix A: Audits and Evaluations ....................................................................... 14
Appendix B: Investigative Actions ........................................................................... 19
Appendix C: Audit Details ....................................................................................... 20
Appendix D: Safe Harbor Proposals ........................................................................ 21
Appendix E: Peer Reviews ....................................................................................... 24
Appendix F: Reporting Requirements ..................................................................... 25
Stay in Touch .......................................................................................................... 26
Report Fraud, Waste, and Abuse ............................................................................ 27
A Message From
the Inspector General
I am pleased to submit this Semiannual Report to Congress summarizing the
activities of the Department of Health and Human Services (HHS or the
Department), Office of Inspector General (OIG) for the 6-month period
ending on September 30, 2024.
OIG provides independent, objective oversight for HHS’s more than $2
trillion in annual expenditures and more than 100 health and human services
programs. OIG’s investigators, auditors, evaluators, attorneys, data
scientists, and other professionals focus on identifying improper payments,
ensuring high-quality and safe care, and holding wrongdoers accountable.
Our work helps ensure that taxpayers are getting good value for their
investments in HHS programs.
OIG’s dedicated workforce continues to deliver exceptional results for the American public in achieving the
mission set for us by Congress: to detect and prevent fraud, waste, and abuse and to promote the economy,
efficiency, and effectiveness of HHS programs. For fiscal year 2024, OIG identified $7.13 billion in expected
recoveries and receivables through our investigative and audit work. OIG achieved 1,548 civil and criminal
results and excluded 3,234 individuals and entities from participating in Federal health care programs.
OIG is the Nation’s leading health care fraud investigative agency. In June, OIG participated in the 2024
National Health Care Fraud Enforcement Action with the Department of Justice and other Federal, State, and
local law enforcement partners. This Enforcement Action resulted in criminal charges against 193 defendants
in 32 Federal districts for alleged participation in fraud schemes, including kickbacks and fraudulent billing for
expensive amniotic wound grafts and addiction treatment, unlawful distribution of stimulants over the
internet, distribution of adulterated and misbranded HIV medication, and fraudulent telemedicine and genetic
testing schemes. The conduct charged involved approximately $2.75 billion in intended losses to Government
programs and taxpayers.
In this reporting period, OIG continued to tackle the most pressing and complex issues facing the
Department’s programs using our full range of authorities and resources. We use a risk-based approach to
identify, prioritize, and mitigate evolving threats and maximize the return on American taxpayers’ investment
in OIG. We endeavor to prevent fraud before people and programs can be harmed. We use sophisticated
data analytics and modern investigative techniques to detect fraud and stop it faster. Our audits and
evaluations uncover program vulnerabilities and make recommendations for meaningful improvements to
reduce risk and improve program operations.
For example, OIG has continued to prioritize investigations in areas particularly vulnerable to criminal
schemes, such as durable medical equipment. During this reporting period, our investigators worked with the
Department of Justice to prosecute two brothers who used aggressive telemarketing strategies and bribed
doctors to order unnecessary durable medical equipment. The brothers were sentenced to jail and ordered to
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pay more than $424 million in restitution. We also excluded a nurse practitioner who had been convicted of a
$192 million durable medical equipment fraud scheme from participating in Federal health care programs.
Additionally, our audit work identified key vulnerabilities in CMS’s oversight of durable medical equipment
and recommended actions CMS should take to reduce risks of fraud, waste, and abuse and protect the health
of Medicare enrollees.
HHS is the Federal Government’s largest grant-making agency and the fourth largest contracting agency.
During this reporting period, OIG published a Strategic Plan titled Safeguarding the Integrity of HHS Grants and
Contracts that describes our strategy for vigorous oversight using data and advanced analytics to safeguard
taxpayer dollars, hold poor performers accountable, and protect the people that HHS programs serve. We
also identified gaps in the Department’s oversight of grants and contracts that allowed HHS funds to be
misspent and put people at risk. For example, OIG pursued bad actors who diverted funds from a Substance
Abuse and Mental Health Services Administration grant intended to prevent youth substance abuse. Our
actions helped protect Federal grant dollars and ensured that the program could better serve this population.
OIG’s innovative, data-driven, technology-savvy workforce produces outsized impacts for the American
people. OIG’s work consistently yields a positive health care return on investment of around $10 returned for
every $1 invested, including expected and actual recoveries of funds to HHS programs. As evidenced by this
report, our work identifies misspent taxpayer funds, stops fraud, and finds opportunities to improve the
quality and efficiency of HHS programs. OIG stands ready to do even more. With additional resources, we
have in place the infrastructure and expertise to deliver even greater results for the American people.
We appreciate the continued support of Congress and HHS for OIG’s important work.
Christi A. Grimm
Inspector General
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At a Glance: OIG Accomplishments
The Department of Health and Human Services (HHS or the Department), Office of Inspector General (OIG)
oversees more than 100 health and human services programs to ensure that more than $2.5 trillion in
taxpayer funds are responsibly spent and that the more than 150 million Americans who rely on those
programs are well served. OIG focuses on the most significant and high-risk issues in health care and human
services. OIG also remains at the forefront of the Nation’s efforts to fight fraud in HHS programs and hold
wrongdoers accountable for their actions. The graphic below features a few of our fiscal year (FY) 2024
accomplishments.
Reporting Period Specific Accomplishments
During the semiannual reporting period of April 1, 2024, through September 30, 2024 (reporting period), our
investigative and audit efforts identified $4.36 billion in expected recoveries and receivables. We also issued
53 audits and 22 evaluations to HHS in which we identified systemic weaknesses and opportunities for
improvement. See Appendix A for a full list of these audits and evaluations, including the identified
questioned costs, funds put to better use, and unsupported costs.
The scope of our work extended beyond identifying concerns; during the reporting period, we issued 239 new
recommendations that, if implemented, will foster sustainable program improvements and safeguard
taxpayer funds. Further, HHS and non-HHS entities implemented 187 recommendations to address problems
we identified in previous audits and evaluations. Our enforcement efforts through our investigative and
counsels’ offices resulted in more than 836 civil and criminal actions during this reporting period, which
includes settlements resulting from using OIG’s civil monetary penalty authorities and criminal convictions.
Additionally, we identified and excluded 1,439 bad actors from participation in Federal health care programs
during this reporting period, ensuring that untrustworthy actors don't receive Federal health care program
payment.
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Introduction
The Inspector General Act of 1978 (Public Law 95-452), as amended, requires that the Inspector General
report semiannually to the head of the Department and to Congress on the activities of the office. The
semiannual reports are intended to keep the Secretary and Congress fully informed of significant current
findings and recommendations.
Semiannual Report Restructure
Beginning with the Spring 2024 semiannual report, we have restructured these reports based on recent
congressional reforms that streamline and modernize reporting requirements and allow inspectors general to
focus on the most significant activities and critical issues facing the departments they oversee. This revised
semiannual report highlights OIG’s oversight work completed during the reporting period focused on the most
significant issues facing HHS. OIG identifies these significant issues every year in its Top Management and
Performance Challenges Facing HHS (TMCs). OIG identified five TMCs in its 2024 report:
1) Public Health
2) Financial Integrity
3) Medicare and Medicaid
4) Beneficiary Safety
5) Data and Technology Security
Having identified these TMCs for the Department, OIG makes its own investments, using its suite of oversight
and enforcement tools and authorities, to better understand and address these issues. Our mission is to
protect the integrity of HHS programs as well as the health and welfare of the people they serve. We do that,
in part, by strategically focusing our efforts on the areas of greatest vulnerability. The summaries of OIG’s
work in this semiannual report identify key findings, information, and recommendations that could help the
Department address the TMCs and fulfill its mission to enhance the health and well-being of all Americans.
In addition to highlighting OIG’s work related to the TMCs, this report includes a comprehensive overview of
all OIG's work completed in this semiannual reporting period. This overview can be found in six appendices
that provide detailed information on OIG’s oversight, including a full list of OIG audits and evaluations issued
to each HHS operating division during the reporting period. Changes to streamline this semiannual report are
consistent with statutory amendments for inspector general reporting requirements. Appendix F lists each of
the current reporting requirements and the location within this semiannual report where they are met.
Additional Resources
OIG’s website offers additional resources to understand the full scope of OIG’s oversight and enforcement
work, including all reports available by issue area and HHS agency; OIG recommendations to improve
Department programs and reduce vulnerabilities, including the status of those recommendations and those
OIG has identified as top unimplemented recommendations; and OIG enforcement actions. Additional
information on how OIG’s work has a positive financial impact on Medicare and Medicaid can be found in the
annual Health Care Fraud and Abuse Control Program Report.
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1 | Public Health
Opioid Epidemic
HHS funds a wide range of programs to address the opioid epidemic by increasing access to treatment and
reducing overdose-related deaths. OIG’s oversight and enforcement related to the opioid epidemic helps
foster access to treatment, promote compliance with Federal and State requirements, and deter bad actors
from opioid-related drug diversion. Significant OIG work completed during this reporting period related to the
opioid epidemic is detailed below.
Access to Treatment
OIG found that hundreds of counties with high needs for medication
for opioid use disorder (MOUD) services lacked office-based
buprenorphine providers and opioid treatment programs
(i.e., MOUD providers). Even in counties where MOUD providers did
practice, they often did not treat any Medicare or Medicaid
enrollees. Factors that may influence MOUD providers’ ability and
willingness to treat Medicare and Medicaid enrollees include
Medicare Advantage prior authorization requirements, low Medicaid
reimbursement rates, and inadequate public information about
MOUD provider locations (OEI-BL-23-00160).
See OIG’s interactive map for additional detail about these counties (OEI-BL-23-00161).
Oversight of Treatment Programs
OIG found that opioid treatment programs (OTPs) in Washington and Massachusetts did not fully comply with
Federal and State requirements for providing and documenting opioid treatment services. Failure to comply
with these requirements may lead to poor treatment outcomes for individuals, including relapses, overdoses,
or deaths. Specifically, OIG found that Washington OTPs did not adequately document enrollee admissions,
treatment plans, opioid treatment services, the results of drug screens, checks of Washington’s prescription
drug monitoring program data, and enrollee assessments (A-09-21-02001). Additionally, OIG found that OTPs
in Massachusetts met many, but not all, Federal and State requirements and that the State could improve its
oversight of OTPs. Specifically, OIG found OTPs did not review treatment plans every 3 months and did not
document counseling services as required (A-01-23-00002).
Oversight of Opioid Grant Programs
OIG found that West Virginia did not comply with Federal regulations regarding oversight and reporting
requirements for its Opioid State Targeted Response and State Opioid Response (SOR) grants. Specifically,
West Virginia could not support its annual progress reports and did not adequately monitor subrecipient
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spending, nor did it have adequate procedures in place to determine whether it met SOR grant program goals
(A-06-22-01005).
Enforcement Actions
OIG excluded multiple bad actors from federally funded health care programs for opioid-related drug
diversion. For example, OIG excluded a former advanced nurse practitioner for a minimum period of 56 years
following her conviction for illegally prescribing and dispensing opioids outside of the scope of legitimate
medical practice, which resulted in the deaths of five people between 2014 and 2019. She was sentenced to
30 years in prison.
In another example of OIG’s and other law enforcement partners’ work, Endo Health Solutions Inc. (EHSI), an
opioid manufacturer, was ordered to pay $1.54 billion in criminal fines and forfeiture, the second-largest set of
criminal financial penalties ever levied against a pharmaceutical company, for violations of the Federal Food,
Drug, and Cosmetic Act related to the distribution of the opioid medication Opana ER. Specifically, EHSI sales
representatives marketed Opana ER to prescribers by touting the drug’s purported abuse deterrence and
tamper and crush resistance despite a lack of clinical data supporting those claims. EHSI also pled guilty to one
misdemeanor count of introducing misbranded drugs into interstate commerce. This was part of a global
criminal and civil resolution that included a False Claims Act settlement resolving allegations that EHSI’s false
marketing scheme caused the submission of false claims for Opana ER to Federal health care programs.
Maternal Health
U.S. rates of pregnancy and postpartum complications exceed those of any other high-income nation.
Medicaid finances more than 40 percent of all U.S. births and more than half of pregnancies and deliveries in
rural and low-income communities. Most State Medicaid programs require managed care enrollment during
pregnancy and use provider coverage rules and network adequacy standards (i.e., requirements that managed
care organizations [MCOs] include enough providers in their networks) to help ensure adequate access to
care.
OIG found that States could better leverage MCO provider coverage requirements and network adequacy
standards to promote access to maternal health care (OEI-05-22-00330). Specifically, OIG found that:
Beyond obstetrician/gynecologist (OB/GYN) physicians and hospitals, many States reported they do
not require MCOs to cover important types of maternal health providers and professionals, some of
whose services are federally required.
Some States are not using network adequacy standards to address important dimensions of maternal
health care access. For example, some measure access to specific provider types such as OB/GYNs, but
many do not. Some tailor their standards to maternal health care needs (e.g., by varying appointment
wait time requirements by pregnancy stage), while others do not.
All States reported monitoring MCOs’ compliance with network adequacy standards, but they may lack
data on the standards’ impact on access to maternal health care.
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Food Safety
The Food and Drug Administration (FDA) is responsible for maintaining the safety of the Nation’s food supply.
The FDA develops policies and procedures to hold food manufacturers accountable for the safety of the foods
they grow, make, and sell—including infant formula. In response to a recall of certain Abbott Laboratories
powdered infant formula products and related congressional concerns, OIG conducted work that found that
FDA lacked or had inadequate policies and procedures to identify risks to infant formula and respond
effectively through its complaint, inspection, and recall processes. For example, FDA had not developed an
organizational structure or assigned responsibilities to handle whistleblower complaints in an efficient and
effective manner and took more than 15 months to address a February 2021 Abbott facility whistleblower
complaint. OIG also found that FDA did not have policies and procedures to establish timeframes for the
initiation of mission-critical inspections, nor did it have sufficient policies and procedures on how to initiate an
infant formula recall under its FDA-required recall authority (A-01-22-01502).
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2 | Financial Integrity
OIG’s oversight identifies and reduces improper payments, promotes efficient and effective ways to address
costs, and ensures good financial stewardship by recommending program improvements. In addition, OIG
recognizes the importance of identifying and holding accountable those who defraud Medicare, Medicaid,
other HHS programs, enrollees, and taxpayers. Significant OIG work completed during this reporting period
related to improper payments, cost effectiveness, and program integrity in all HHS programs is detailed below.
Improper Payments
OIG found Medicare improperly paid hospitals an estimated $79 million realted to mechanical ventilation.
Hospitals attributed the improper billing to incorrectly counting the hours that enrollees had received
mechanical ventilation or clerical errors in selecting procedure or diagnosis codes (A-09-22-03002).
CASE EXAMPLE
Pharmacy Owners Sentenced for $18 Million COVID-19 Health Care Fraud and Money
Laundering
As a result of OIG’s and other law enforcement partners’ work, Peter Khaim and his brother Arkadiy
Khaimov were sentenced to 8 years and 6 years in prison, respectively, for using pharmacies to
submit millions of dollars in fraudulent claims to Medicare and for money laundering. Khaim was
ordered to pay more than $18 million in restitution and to forfeit more than $2.7 million. Khaimov
was ordered to pay more than $18 million in restitution and to forfeit more than $9.6 million. The
brothers and their co-conspirators used COVID-19 related emergency override billing codes to
submit claims for cancer medications that were not prescribed or dispensed. They funneled money
to shell companies. The funds were then typically sent to companies in China for distribution to
individuals in Uzbekistan. The defendants received cash from a co-conspirator, minus a
commission. At other times, the funds were sent from the sham companies to the brothers, their
relatives, or their designees via certified cashier’s checks and cash. The brothers used the proceeds
of the scheme to purchase real estate and other luxury items.
Enforcement Action
OIG excluded an unlicensed individual posing as a physican for a minimum of 49 years for his role in a home
health care fraud scheme. The individual acted in the role of a physician to qualify patients for home health
services. He was convicted in a jury trial of conspiracy to commit health care fraud, ordered to pay more than
$11 million in restitution, and sentenced to 168 months in prison. His co-conspirator, an owner of numerous
home health agencies, was also convicted of conspiracy to commit health care fraud, excluded for a minimum
of 45 years, ordered to pay more than $27 million in restitution, and sentenced to 60 months in prison.
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Cost Effectiveness
OIG found that Medicare and some enrollees paid 80 percent In 2021, the annual cost per enrollee
more when Stelara injections, a high-cost prescription biologic for Stelara was 80% more under Part D
approved to treat certain autoimmune diseases, were covered than Part B
under Part D (i.e., self-administered) versus under Part B (i.e.,
administered by a physician). However, given recent coverage
changes, enrollees who once opted to receive Stelara injections in
their doctors’ offices (i.e., through Part B) must now obtain Stelara
through a pharmacy (i.e., through Part D), where they will
potentially face much higher out-of-pocket costs. Our findings
illustrate how differences in the methods used to set drug payment
amounts under Part B (i.e., manufacturers’ sales prices) versus under Part D (i.e., negotiations between plan
sponsors, manufacturers, pharmacy benefit managers, and pharmacies) result in widely different payment
amounts for the same drugs (OEI-BL-19-00500).
Program Integrity
Contracts Administration
Closing contracts is generally the last chance for the Government to detect and recover improper contract
payments. A delayed closeout poses a financial risk to agency funds. OIG found the National Institutes of
Health (NIH) did not always close contracts in accordance with Federal regulations and HHS policies and
procedures. Specifically, OIG reviewed 30 judgmentally selected contracts totaling $2.1 billion and found that
for 29 of the contracts, NIH did not meet one or more administrative closeout requirements (e.g., performing
a contract audit) (A-04-23-03585).
Medicare Rules and Compliance
OIG identified three weaknesses in the Centers for Medicare & Medicaid Services’ (CMS’s) established
program safeguards for preventing and detecting improper payments for short inpatient stays and recovering
overpayments. Specifically, for claims at risk for noncompliance with the two-midnight rule, CMS did not
have: (1) adequate information to identify short inpatient stays, (2) prepayment edits, or (3) adequate policies
and procedures to review these claims and recover overpayments (A-09-21-03022).
Service Oversight
OIG identified the need for additional oversight of remote patient monitoring services in Medicare to ensure
that it is being used and billed appropriately. The number of Medicare enrollees who received remote patient
monitoring was more than 10 times higher in 2022 than in 2019. OIG found Medicare lacks key information
for oversight, including who ordered monitoring services for enrollees. The use of remote patient monitoring
has the potential to continue expanding in the Medicare population. As a result, there is an increasing need to
know how remote patient monitoring is being used, including who is receiving it and for what conditions, as
well as a need to identify any vulnerabilities that may limit the oversight of these services (OEI-02-23-00260).
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SPOTLIGHT ON ORTHOTIC BRACES
In calendar year 2023, Medicare paid approximately $485 million for orthotic
braces provided to Medicare enrollees. Medicare remains vulnerable to fraud,
waste, and abuse related to these orthotic braces, which may result in
improper payments and impact the health of enrollees. Orthotic braces are
consistently among the top 20 durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS) items with the highest improper payment
rates. For example, in 2023, the improper payment rate for orthotic braces
was between 36 and 41 percent.
OIG WORK THIS REPORTING PERIOD
OIG identified vulnerabilities related to OIG excluded an advanced registered nurse
off-the-shelf orthotic braces (A-09-21-03019). practitioner for 97 years.
• Providers ordered braces for enrollees for whom OIG excluded Elizabeth Hernandez, an advanced
there was no history of a treating relationship. registered nurse practitioner, for 97 years based on her
• New suppliers started doing business in geographic conviction for her role in a scheme to defraud Medicare
areas with known fraud. by submitting more than $192 million in claims for
• Medicare paid more than private payers for orthotic braces and other items patients did not need
off-the-shelf braces. and telemedicine visits that did not occur. Hernandez
• Suppliers used prohibited solicitation to contact was ordered to pay approximately $111 million in
enrollees. restitution and was sentenced to 20 years in prison.
OIG worked with the Department of Justice to prosecute bad actors for defrauding Medicare by
submitting false claims and paying kickbacks to physicians.
Charles Burruss and Ardalaan “Armani” Adams were charged with defrauding Burruss and Adams were
Medicare through the submission of claims for medically unnecessary durable sentenced to 42 months
medical equipment (DME), mostly braces. Burruss and Adams paid millions in and 30 months in prison,
kickbacks and bribes to acquire the DME claims, which were generated using respectively, and ordered
aggressive telemarketing strategies in concert with fraudulent telemedicine to pay more than
involving bribed doctors who rarely spoke to the beneficiaries for whom the DME $424 million jointly in
was ordered. Burruss, Adams, and their co-conspirators submitted the illegal restitution. Each also had
DME claims to Medicare and other programs through a conglomerate of a forfeiture judgment
fraudulently established DME companies. The defendants pled guilty before the issued against them for
U.S. District Court and the Southern District of California to one count of more than $424 million.
conspiracy to commit wire fraud, conspiracy to commit healthcare fraud, and
conspiracy to violate the anti-kickback statute.
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3 | Medicare and Medicaid
Nursing Homes
According to recent CMS data, more than 1.2 million people reside in the approximately 15,000 Medicare and
Medicaid certified nursing homes nationwide. Improving nursing home quality of care is a top priority for OIG.
To protect residents, OIG continually assesses nursing home performance and oversight and uses our
enforcement tools to address misconduct. Significant OIG work completed during this reporting period
related to nursing home quality and safety is detailed below.
Infection Prevention and Control
OIG reviewed 100 for-profit nursing homes nationwide and
found that 24 potentially did not meet Federal requirements
pertaining to infection preventionists. Infection preventionists
are responsible for facility infection prevention and control.
Based on our sample results, OIG estimates that 2,568
(approximately 1 in 4) for-profit nursing homes nationwide may
not have complied with Federal requirements for infection
preventionists during our review period. As a result, there may
be increased health and safety risks for the residents and staff of
these nursing homes (A-01-22-00001).
Enforcement Actions
OIG excluded a certified nursing aide (CNA) for a minimum of 25 years based on his conviction for injuring a
nursing home resident, who ultimately died, and tampering and fabricating physical evidence. The resident
fell and suffered a head wound and two broken ribs after the CNA tied him to his wheelchair using a bedsheet.
The CNA was sentenced to 5 years in prison.
CASE EXAMPLE
Strauss Ventures, LLC To Pay $21.3 Million in a False Claims Act Settlement for Fraudulent
Rehabilitation Therapy Services
Strauss Ventures LLC, doing business as The Grand Health Care System, and 12 affiliated skilled
nursing facilities agreed to pay $21.3 million in a False Claims Act settlement with the United
States. The settlement resolved allegations that, from January 1, 2014, through September 30,
2019, twelve of Strauss Ventures’ skilled nursing facilities submitted false claims to Medicare Part A
and TRICARE for medically unnecessary, unskilled, or not provided rehabilitation therapy. As part
of the settlement, Strauss Ventures entered into a 5-year corporate integrity agreement with OIG.
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In another example of OIG’s work, Supportive Care Holdings, LLC, its related healthcare companies, and its
CEO agreed to pay more than $4.5 million in a False Claims Act settlement with the United States. The
settlement resolved allegations that between 2019 and 2023, Supportive Care Holdings, LLC, and its CEO
fraudulently and improperly billed Medicare and Connecticut Medicaid for telehealth services provided to
nursing home residents that should only have been billed by the nursing homes. The settlement also resolved
allegations that Supportive Care Holdings, LLC, and its CEO submitted false claims for psychological services for
nursing home residents who did not actually reside in a nursing home.
Medicaid
OIG oversight of Medicaid ensures that CMS and States comply with Federal requirements, ensures program
integrity, and identifies improper payments. Significant OIG work completed during this reporting period
related to Medicaid payments, enrollment data, and eligibility actions is detailed below.
Payment Accuracy
OIG found that State agencies generally did not comply with Federal Medicaid requirements for invoicing
manufacturers for rebates for physician-administered drugs. In the aggregate, State agencies could have
invoiced and obtained rebates from the manufacturers for $225.7 million (Federal share) for physician-
administered drugs reimbursed on a fee-for-service basis. States also should have collected additional rebates
associated with $236.2 million (Federal share) for physician-administered drugs administered to Medicaid
MCO enrollees (A-07-23-06111).
Additionally, OIG found New Mexico performed reconciliations of capitated payments for community benefit
(CB) services as required under its contracts with MCOs. However, it did not recoup $139.2 million in
overpayments for enrollees who did not use CB services within 90 calendar days of their approval for CB
services and, as a result, did not return the related Federal share of $98.6 million. Additionally, New Mexico
did not provide support that the enrollees on whose behalf MCOs received $35.2 million in capitated
payments at the higher nursing facility level-of-care rate were eligible for services at that rate. As a result, it
claimed $29.4 million in overpayments for those enrollees and inappropriately received $20.5 million in
Federal share for those overpayments (A-06-20-09001).
Enrollment Data Accuracy
State agencies are required to verify the State of residency for enrollees; however, OIG estimates that
California incurred costs of approximately $19.9 million ($15.5 million Federal share) for August 2021
capitation payments made on behalf of enrollees who were residing and concurrently enrolled in a Medicaid
managed care program in another State (A-05-23-00008). Additionally, OIG found California improperly
claimed $52.7 million in Federal Medicaid reimbursement for capitation payments made on behalf of
noncitizens with unsatisfactory immigration status (A-09-22-02004).
Eligibility Actions
States ensured most Medicaid enrollees were continuously enrolled for Medicaid benefits during the COVID-
19 public health emergency. When the continuous enrollment condition period ended, States had to conduct
a variety of Medicaid eligibility actions such as redetermining eligibility status for enrollees during a period
known as unwinding. OIG audited four States and determined that all four—Ohio (A-05-23-00019), Utah (A-
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07-24-07013), California (A-09-24-02001), and Massachusetts (A-02-24-01001)—generally completed the
actions in accordance with Federal and State requirements.
Medicaid Fraud Control Units
Medicaid Fraud Control Units (MFCUs) are key partners with OIG in the fight against fraud, waste, and abuse
in State Medicaid programs. OIG has oversight responsibility for MFCUs and administers grants that provide
Federal funding for their operations. MFCUs investigate and prosecute Medicaid provider fraud, as well as
abuse or neglect of residents in health care facilities and board and care facilities and of Medicaid enrollees in
noninstitutional or other settings. During the reporting period, OIG and MFCUs worked together on
1,329 joint investigations. Additionally, our joint work resulted in 237 civil settlements or Civil Monetary
Penalty Law outcomes and 426 criminal adjudications. For information about MFCU accomplishments, see
our FY 2023 MFCU Annual Report. Additionally, during the reporting period, OIG revised its MFCU
performance standards to further support MFCUs operations, performance, and program integrity efforts.
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4 | Beneficiary Safety
Access to Services
Access to services is a principle of federally funded health care programs, including Medicaid. Enrollees should
have access to providers who administer safe, effective, and equitable screenings and care in a thorough,
timely, and efficient manner. Significant OIG work completed during this reporting period related to access to
screenings and care is detailed below.
OIG found that Medicaid enrollees may not be screened for intimate partner violence (IPV)—which includes
physical, sexual, and psychological abuse perpetrated by a spouse or partner. Primary care clinicians who
serve Medicaid enrollees reported a range of challenges to screening for IPV. The most frequently reported
challenge was time constraints; other barriers included concerns
about patient privacy and safety and inadequate training. Among
primary care clinicians who screened patients for IPV, additional
challenges hindered their ability to make referrals, such as
limitations with IPV support resources for patients who screen
positive (OEI-03-21-00310).
OIG identified systemic and operational challenges that hinder
efforts to ensure HIV care for Medicaid enrollees. Specifically,
States and plans reported that two systemic issues—unmet health-
related social needs and provider shortages—impact enrollees’
abilities to maintain their care and limit States’ and plans’ abilities
to address resulting gaps in care. Further, States and plans
reported that two operational challenges—limited access to data
and insufficient administrative staff—impact States’ and plans’
efforts to monitor enrollees’ care needs and take action to connect
enrollees to care (OEI-05-22-00242).
Children in Foster Care
HHS provides or funds services to children through programs such as foster care. OIG oversees these
programs to ensure that children receive appropriate services in safe environments free from potential harm.
Significant OIG work completed during this reporting period related to the health and safety of children in
foster care is detailed below.
OIG found that many State child welfare agencies lack information to monitor maltreatment in residential
facilities for children in foster care. States reported missing or incomplete information in the following key
areas that could support enhanced oversight of residential facilities for children, although collecting and
sharing this information is not required by Federal law (OEI-07-22-00530):
11
Nearly one-third of States could not identify patterns of maltreatment in residential facilities within
their State.
States had limited awareness of maltreatment that occurred across chains of residential facilities
operating in multiple States.
States reported challenges monitoring the safety of children placed in out-of-State residential facilities.
Thirteen States did not consistently report to the national maltreatment database whether children
who experienced maltreatment were living in a residential facility.
Additionally, OIG found that most children in foster care, who are vulnerable to identity theft, did not receive
federally required credit checks and assistance in interpreting and resolving any inaccuracies identified.
Specifically, more than half of the children in foster care who should have received credit checks did not
receive any credit checks in FY 2021. Further, for 4 percent of children who received at least one credit check,
they rarely received assistance in interpreting or resolving credit reports, as required (OEI-07-22-00510).
12
5 | Data and Technology
Security
HHS faces persistent cybersecurity threats that exacerbate the challenges associated with data and
technologies used to carry out the Department’s vital health and human services missions. OIG oversight
helps ensure that HHS’s cybersecurity is effective by auditing the Department’s systems and operations along
with the systems and operations of contractors and others that work with HHS. Significant OIG work
completed during this reporting period related to securing data and technology is detailed below.
Cybersecurity Compliance
OIG audits aim to further cybersecurity compliance for HHS programs, grantees, and contractors. For
example, OIG found through the annual audit of the Department’s compliance with the Federal Information
Security Modernization Act of 2014 that HHS’s information security program was not effective. However,
large disparities exist between the maturity levels at individual operating and staff divisions (A-18-23-11200).
In another example, OIG found that despite some identified gaps and deficiencies, the evaluations of seven
Medicare Administrative Contractors were adequate in scope and sufficiency (A-18-24-11300).
Sensitive Data
OIG oversight work ensures the confidentiality, integrity, and availability of sensitive data. For example, OIG
reviewed HHS’s cloud information system inventory and its policies and procedures in 2022 and found that
not all of its cloud systems had been accurately identified and inventoried in accordance with HHS security
requirements. Additionally, several key security controls were not effectively implemented in accordance with
Federal requirements and guidelines. These issues occurred because System Security Officers do not always
have the skill sets or experience necessary to adequately perform their roles and responsibilities. HHS
concurred with our recommendations and is taking steps to implement them (A-18-22-08018). In one audit of
State Medicaid information systems, OIG reviewed Illinois’s systems for Medicaid eligibility determinations
and claims processing and information retrieval, which store protected health information and other sensitive
information. OIG found that, although the State’s security controls were adequate, its security controls could
be improved. Illinois stated it is taking action to make improvements (A-18-22-09009).
13
Appendix A: Audits and Evaluations
The following table summarizes OIG’s audit and evaluation reports issued during the reporting period, including, if applicable, the associated
questioned costs, funds put to better use, unsupported costs, and whether a management decision was made during the reporting period. (OIG
has not yet received management decisions for most reports listed below because those decisions are not due to OIG until 6 months following the
issuance of a report.) OIG issued two nonpublic audits during this reporting period. See Appendix C for more detail about reports with questioned
costs and funds put to better use.
Questioned Funds Put to Unsupported Management
Report
Costs Better Use Costs Decision Made
Administration for Children and Families (ACF)
Many States Lack Information To Monitor Maltreatment in Residential Facilities for Children
- - - -
in Foster Care (OEI-07-22-00530), June 2024
Most Children in Foster Care Did Not Receive Credit Checks and Assistance (OEI-07-22-00510),
- - - -
September 2024
Administration for Community Living (ACL)
Missouri May Not Have Used All CARES Act Funds for the Older Americans Act Nutrition
Services Program in Accordance With Federal and State Requirements (A-07-22-04130), - - - -
April 2024
2023 Performance Data for the Senior Medicare Patrol Projects (OEI-02-24-00260), June 2024 - - - -
Administration for Strategic Preparedness and Response (ASPR)
Fiscal Year 2018 and 2019 Biomedical Advanced Research and Development Authority
Appropriations May Not Have Been Used for Their Intended Purpose in Accordance With - - - -
Federal Requirements (A-03-20-03002), April 2024
ASPR Did Not Consistently Comply With Federal Requirements for Awarding Research and
$28,000 - $14,000 -
Development Contracts (A-03-20-03003), July 2024*
ASPR Established Adequate Controls for Maintaining Physical Security Over Stockpile Site A,
- - - -
but Some Inventory Discrepancies Were Identified (A-04-24-02044), September 2024
Centers for Disease Control and Prevention (CDC)
Selected CDC Racial and Ethnic Approaches to Community Health Program Recipients
Generally Complied With Federal Requirements but Did Not Meet All Targets and Charged $1,613,612 - - -
Some Unallowable Costs (A-02-22-02001), May 2024
Heluna Health May Not Have Used California’s CDC COVID-19 Funds in Accordance With
$3,585,834 $366,850,858 - -
Award Requirements (A-04-22-02037), July 2024
14
Questioned Funds Put to Unsupported Management
Report
Costs Better Use Costs Decision Made
CDC Provided Oversight and Assistance, but Recipients Faced Challenges in Implementing a
- - - -
COVID-19 Vaccine Confidence Strategy (A-06-22-04004), July 2024
Centers for Medicare & Medicaid Services (CMS)
Medicaid Enrollees May Not Be Screened for Intimate Partner Violence Because of Challenges
- - - -
Reported by Primary Care Clinicians (OEI-03-21-00310), April 2024
New York Generally Identified and Corrected Duplicate Children’s Health Insurance Plan
- - - -
Payments Made to Managed Care Organizations (A-02-23-01017), April 2024
Alabama Claimed Federal Medicaid Reimbursement for Millions of Dollars in Targeted Case
Management Services That Did Not Comply With Federal and State Requirements (A-07-22- $5,039,433 - - Yes
03253), April 2024
CMS Could Improve Its Procedures for Setting Medicare Clinical Diagnostic Laboratory Test
Rates Under the Clinical Laboratory Fee Schedule for Future Public Health Emergencies (A-01- - - - -
21-00506), April 2024
Ohio Generally Completed Medicaid Eligibility Actions During the Unwinding Period in
- - - -
Accordance With Federal and State Requirements (A-05-23-00019), April 2024
Florida Ensured That Nursing Homes Complied With Federal Background Check Requirements
- - - -
(A-04-23-08100), April 2024
Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Fourth
- - - -
Quarter of 2023 (OEI-03-24-00060), May 2024
Medicaid Managed Care: States Do Not Consistently Define or Validate Paid Amount Data for
- - - -
Drug Claims (OEI-03-20-00560), May 2024
California Generally Completed Medicaid Eligibility Actions During the Unwinding Period in
- - - -
Accordance With Federal and State Requirements (A-09-24-02001), May 2024
New Mexico Should Refund Almost $120 Million to the Federal Government for Medicaid
$119,118,308 - - Yes
Nursing Facility Level-of-Care Managed Care Capitated Payments (A-06-20-09001), May 2024
Potential Vulnerabilities in CMS Oversight of Medicare Add-on Payments for COVID-19 Tests
- - - -
Show That Oversight of Incentive Payments Could Be Improved (A-09-22-03015), May 2024
State Agencies Could Be Obtaining Hundreds of Millions in Additional Medicaid Rebates
- - - -
Associated With Physician-Administered Drugs (A-07-23-06111), May 2024
Colorado Did Not Report and Refund the Correct Federal Share of Medicaid-Related
Overpayments for Some Cases Identified by the State’s Program Integrity Section (A-07-19- $673,686 - - Yes
02816), May 2024
California Improperly Claimed $52.7 Million in Federal Medicaid Reimbursement for
Capitation Payments Made on Behalf of Noncitizens With Unsatisfactory Immigration Status $52,652,689 - - Yes
(A-09-22-02004), May 2024
Medicare Remains Vulnerable to Fraud, Waste, and Abuse Related to Off-the-Shelf Orthotic
Braces, Which May Result in Improper Payments and Impact the Health of Enrollees (A-09-21- - - - -
03019), May 2024
Washington Medicaid Fraud Control Unit: 2023 Inspection (OEI-09-23-00230), June 2024 - - - -
15
Questioned Funds Put to Unsupported Management
Report
Costs Better Use Costs Decision Made
CMS Could Strengthen Program Safeguards To Prevent and Detect Improper Medicare
- - - -
Payments for Short Inpatient Stays (A-09-21-03022), June 2024
North Carolina Did Not Report and Return All Medicaid Overpayments for the State’s
$20,134,402 - - Yes
Medicaid Fraud Control Unit Cases (A-06-23-04004), June 2024
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Independent Health
$646,217 - - Yes
Association, Inc. (Contract H3362) Submitted to CMS (A-07-19-01194), June 2024
Part D Plans Generally Include Drugs Commonly Used by Dual-Eligible Enrollees: 2024 (OEI-05-
- - - -
24-00210), July 2024
West Virginia Medicaid Fraud Control Unit: 2023 Inspection (OEI-09-23-00390), July 2024 - - - -
Alaska Medicaid Fraud Control Unit: 2023 Inspection (OEI-07-23-00240), July 2024 - - - -
California Made Capitation Payments for Enrollees Who Were Concurrently Enrolled in a
Medicaid Managed Care Program in Another State (A-05-23-00008), July 2024
- - - -
Medicare and Some Enrollees Paid Substantially More When Stelara Was Covered Under Part
D Versus Part B (OEI-BL-19-00500), August 2024
- - - -
Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the First
Quarter of 2024 (OEI-03-24-00070), August 2024
- - - -
Opioid Treatment Programs in Washington State Did Not Fully Comply With Federal and State
Requirements, Which May Have Put Medicaid Enrollees at Risk for Poor Treatment Outcomes - - - -
(A-09-21-02001), August 2024
Medicare Improperly Paid Hospitals an Estimated $79 Million for Enrollees Who Had Received
$382,032 $79,354,175 - -
Mechanical Ventilation (A-09-22-03002), August 2024
Massachusetts Generally Completed Medicaid Eligibility Actions During the Unwinding Period
- - - -
in Accordance With Federal and State Requirements (A-02-24-01001), August 2024
Medicare Advantage Compliance Audit of Diagnosis Codes That MMM Healthcare, LLC,
$165,312 - - Yes
(Contract H4003) Submitted to CMS (A-04-20-07090), August 2024
Illinois MMIS and E&E System Had Adequate Security Controls in Place, but Some
- - - -
Improvements Are Needed (A-18-22-09009), August 2024
Certain For-Profit Nursing Homes May Not Have Complied With Federal Requirements
- - - -
Regarding the Infection Preventionist Position (A-01-22-00001), August 2024
Kansas’s Implemented Electronic Visit Verification System Could Be Improved (A-07-23-
- - - -
03255), August 2024
New Mexico Did Not Ensure Attendants Were Qualified To Provide Personal Care Services,
- - - -
Putting Medicaid Enrollees at Risk (A-06-22-02000), August 2024
Utah Generally Completed Medicaid Eligibility Actions During the Unwinding Period in
- - - -
Accordance With Federal and State Requirements (A-07-24-07013), August 2024
South Carolina Did Not Always Invoice Rebates to Manufacturers for Physician-Administered
Drugs Dispensed to Enrollees of Medicaid Managed-Care Organizations (A-07-22-07010), $14,151,294 - - -
August 2024
Massachusetts Opioid Treatment Program Services Met Many of the Federal and State
- - - -
Requirements (A-01-23-00002), August 2024
16
Questioned Funds Put to Unsupported Management
Report
Costs Better Use Costs Decision Made
Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2022 Average Sales
- - - -
Prices (OEI-03-24-00080), September 2024
Medicare and Medicaid Enrollees in Many High-Need Areas May Lack Access to Medications
- - - -
for Opioid Use Disorder (OEI-BL-23-00160), September 2024
OIG Companion Product: Medicare and Medicaid Enrollees in Many High-Need Areas May
- - - -
Lack Access to Medications for Opioid Use Disorder (OEI-BL-23-00161), September 2024
Additional Oversight of Remote Patient Monitoring in Medicare Is Needed (OEI-02-23-00260),
- - - -
September 2024
Systemic and Operational Challenges Hinder Efforts to Ensure HIV Care for Medicaid Enrollees
- - - -
(OEI-05-22-00242), September 2024
States Could Better Leverage Coverage and Access Requirements To Promote Maternal Health
- - - -
Care Access in Medicaid Managed Care (OEI-05-22-00330), September 2024
Novitas Solutions, Inc., Reopened and Corrected Cost Report Final Settlements With Obvious
Errors To Collect Overpayments Made to Medicare Providers (A-06-23-05001), - - - -
September 2024
CMS Recovered Medicare Payments to Providers Under the COVID-19 Accelerated and
Advance Payments Program in Compliance With Federal Requirements (A-05-23-00005), - - - -
September 2024
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That Humana Health Plan,
$6,777,385 - - -
Inc., (Contract H2649) Submitted to CMS (A-02-22-01001), September 2024
Medicare Advantage Compliance Audit of Specific Diagnosis Codes That HealthAssurance
$4,256,568 - - -
Pennsylvania, Inc. (Contract H5522) Submitted to CMS (A-05-22-00020), September 2024
Medicare Advantage Compliance Audit of Diagnosis Codes That EmblemHealth (Contract
$551,917 - - -
H3330) Submitted to CMS (A-06-18-02001), September 2024
Review of Medicare Administrative Contractor Information Security Program Evaluations for
- - - -
Fiscal Year 2023 (A-18-24-11300), September 2024
Food and Drug Administration (FDA)
The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To
Ensure the Safety of the Infant Formula Supply (A-01-22-01502), June 2024 - - - -
Health Resources and Services Administration (HRSA)
A Review of Pandemic Relief Funding and How It Was Used in Six U.S. Communities:
Springfield, Massachusetts (OEI-06-22-00440), May 2024 - - - -
A Review of Pandemic Relief Funding and How It Was Used in Six U.S. Communities: Coeur
d'Alene, Idaho (OEI-06-22-00450), July 2024 - - - -
A Review of Pandemic Relief Funding and How It Was Used in Six U.S. Communities: Sheridan
County, Nebraska (OEI-06-22-00460), September 2024 - - - -
Indian Health Service (IHS)
17
Questioned Funds Put to Unsupported Management
Report
Costs Better Use Costs Decision Made
Gallup Indian Medical Center—an IHS-Operated Health Facility—Did Not Timely Conduct
Required Background Checks of Staff and Supervise Certain Staff (A-02-23-02006), - - - -
September 2024
National Institutes of Health (NIH)
Plans and Enrollment Often Fell Short for Underrepresented Groups in a Sample of NIH-
Funded Clinical Trials (OEI-01-21-00320), May 2024 - - - -
New York Medical College Claimed Unallowable Grant Costs and Did Not Meet Certain
Financial Conflict of Interest Requirements (A-04-20-03583), May 2024 $7,542,821 - - -
NIH Did Not Close Contracts in Accordance With Federal Requirements, Resulting in the
Increased Risk of Fraud, Waste, and Abuse (A-04-23-03585), June 2024* - - - -
The National Institutes of Health Has Made Progress but Could Further Improve Its Closeout
Process for Grants and Similar Awards (A-04-23-08097), June 2024 - - - -
The National Institutes of Health Administered Superfund Appropriations During Fiscal Year
2023 in Accordance With Federal Requirements (A-04-24-02045), August 2024 - - - -
Office of the Secretary (OS)
The Office of Intergovernmental and External Affairs’ Purchase Card Program Did Not Comply
With Federal and HHS Requirements (A-03-22-00500), April 2024 - - - -
Department of Health and Human Services Met Many Requirements, but It Did Not Fully
Comply With the Payment Integrity Information Act of 2019 and Applicable Improper - - - -
Payment Guidance for Fiscal Year 2023 (A-17-24-52000), May 2024
Review of the Department of Health and Human Services' Compliance With the Federal
Information Security Modernization Act of 2014 for Fiscal Year 2023 (A-18-23-11200), - - - -
June 2024
HHS Office of the Secretary Needs to Improve Key Security Controls To Better Protect Certain
Cloud Information Systems (A-18-22-08018), July 2024 - - - -
Substance Abuse and Mental Health Services Administration (SAMHSA)
West Virginia Lacked Effective Oversight of Its Opioid Response Grants (A-06-22-01005),
- - - -
April 2024
Total Reports: 73 $237,319,510 $446,205,033 $14,000 -
*Contract audit per NDAA 2008 Section 845
OIG issued no investigative reports, which are reports that identify or bring renewed attention to systemic weaknesses or vulnerabilities within HHS programs and recommend
administrative, procedural, policy, regulatory, or legislative change to correct or minimize the problems. Additionally, OIG issued no non-public evaluation reports.
18
Appendix B: Investigative Actions
The following table summarizes OIG’s investigative activities during the reporting period.
Description
Investigative Receivables
Total $3,936,240,673
Amount due to HHS $2,513,086,238
Amount due to non-HHS entities $1,423,154,435
Investigative Results
Criminal actions resulting from investigations 1 401
Civil or Civil Monetary Penalty Law actions resulting from investigations 435
Investigations closed 896
Referrals 2
Total 1,553
Made to DOJ 1,307
Indictments and criminal informations resulting from referrals made prior to and during the 350
reporting period
Made to State and local authorities 246
Indictments and criminal informations resulting from referrals made prior to and during the 78
reporting period
Related to Trafficking in Persons (FY 2024)
Suspected violations reported 14
Investigations 10
Criminal actions resulting from investigations 3
Recommendations 0
Related to Senior Government Employees
Investigations conducted 5
Allegations substantiated 0
Resulted in a nonpublic report 0
Description of investigation Substantiated Non-public report
OIG investigated two senior Government employees (SES) for allegedly requesting a N N
purchase card transaction to pay for a training that did not occur.
OIG investigated a senior Government employee (GS-15) for allegedly misusing their N N
personal email to conduct Government business in order to circumvent Freedom of
Information Act requirements and for deliberately destroying emails to avoid
production according to Federal regulations.
OIG investigated a senior Government employee (SES) for allegedly sexually N N
assaulting a subordinate employee during international Government travel. The
senior Government employee retired from Federal service.
OIG investigated a senior Government employee (GS-15) for allegedly being charged N N
with criminal trespass and entering or remaining unlawfully in a dwelling.
OIG investigated a senior Government employee (GS-15) for allegedly having a N N
physical altercation with a subordinate employee.
1 Convictions are included among criminal actions.
2 Referrals are presentations of OIG subjects to Federal, State, or local prosecuting jurisdictions for prosecutorial consideration.
19
Appendix C: Audit Details
The table below summarizes potential cost savings that OIG identified during the reporting period including
questioned costs and funds put to better use, as well as OIG’s Single Audit oversight.
No. of Dollar Value Dollar Value
Description
Reports Questioned Unsupported
Audit Reports With Questioned Costs
Section 1
Reports for which no management decisions had been made by the
beginning of the reporting period 24 $1,253,840,000 $376,695,000
Reports issued during the reporting period 16 $237,320,000 $14,000
Total Section 1 40 $1,491,160,000 $376,709,000
Section 2
Reports for which management decisions were made during the reporting period
Disallowed costs 13 $425,424,000* -
Costs not disallowed 5 $741,151,000 $376,695,000
Total Section 2 18 $1,166,575,000 $376,695,000
Section 3
Reports for which no management decisions had been made by the end of
the reporting period (Section 1 – Section 2) 22 $324,585,000 $14,000
Section 4
Reports for which no management decisions were made within 6 months of 13 $285,695,000 -
issuance
* Audit receivables (expected recoveries)
Audit Reports With Funds Put to Better Use
Section 1
Reports for which no management decisions had been made by the
7 - $16,489,698,000
beginning of the reporting period
Reports issued during the reporting period 2 - $446,205,000
Total Section 1 9 - $16,935,903,000
Section 2
Reports for which management decisions were made during the reporting period
Value of recommendations agreed to by management
Based on proposed management action - - -
Based on proposed legislative action - - -
Value of recommendations not agreed to by management 5 - $1,440,253,000
Total Section 2 5 - $1,440,253,000
Section 3
Reports for which no management decisions had been made by the end of
4 - $15,495,650,000
the reporting period (Section 1 – Section 2)
OIG Also Oversees Single Audits To Monitor How Recipients Use Federal Funds for HHS Programs
Single Audit reports reviewed 286 -
Amount of audited costs covered in reviewed reports - $3,100,000,000,000
Amount of Federal dollars covered in reviewed reports - $891,000,000,000
Amount of HHS funds covered in reviewed reports - $479,000,000,000
Read more on OIG’s Single Audits website.
20
Appendix D: Safe Harbor Proposals
OIG annually solicits proposals for developing new and modifying existing safe harbors to the Federal anti-
kickback statute, section 1128B(b) of the Social Security Act, and for developing special fraud alerts. In
December 2023, OIG published its annual solicitation in the Federal Register. Below we summarize the
14 proposals OIG received and OIG’s response.
Proposal OIG Response
Modifications to, and guidance regarding, the group OIG is not adopting these suggestions. We may consider this
purchasing organization (GPO) safe harbor, 42 C.F.R. § topic in future rulemaking or in future guidance. OIG has
1001.952(j), to address comments and concerns regarding the published a response in the Frequently Asked Questions section
manner in which GPOs, pharmacy benefit managers (PBMs), of our website explaining the potential application of the GPO
and similar entities may be using such safe harbor to protect safe harbor to remuneration paid by pharmaceutical
certain purportedly abusive arrangements and to clarify manufacturers to PBMs. Moreover, there is a statutory
whether and under what circumstances the GPO safe harbor exception addressing GPOs at section 1128B(b)(3)(C) of the
applies to PBMs and PBM-operated GPOs. Social Security Act.
New safe harbor to protect arrangements for data analytics OIG is not adopting this suggestion. We believe that existing
provided by a drug, biologic, or device manufacturer (or its safe harbors may be utilized to support these types of
agent) to other parties in the health care coverage, delivery, or arrangements, including, for example, the safe harbor for
patient care chain. personal services and management contracts and outcomes-
based payment arrangements, 42 C.F.R. § 1001.952(d).
New safe harbor for, and guidance regarding, pharmaceutical OIG is not adopting this suggestion. We continue to evaluate the
manufacturer-sponsored patient engagement and product ways in which pharmaceutical manufacturers may be able to
support activities and related tools, outside of the value-based contribute to the coordination of care and the overall delivery of
enterprise framework, to facilitate patient support activities. high-value care; however, we continue to have concerns about
the offer of remuneration by pharmaceutical manufacturers to
Federal health care program enrollees, which raises many of the
traditional fraud and abuse risks under the Federal anti-kickback
statute. We may consider this topic in future rulemaking.
New safe harbors to protect certain remuneration from a OIG is not adopting these suggestions. OIG appreciates the goal
clinical trial sponsor to a patient who participates in the of improving diversity among clinical trial subjects. However, we
sponsor’s clinical trial. The proposed safe harbors would have longstanding concerns regarding the routine waiver or
protect the sponsor’s subsidization of certain costs patients subsidy of cost-sharing obligations and the provision of other
incur due to their participation in a trial, including: (1) cost- incentives to Federal health care program enrollees. We may
sharing obligations and (2) indirect costs such as travel, consider this topic in future rulemaking.
lodging, childcare expenses, and lost wages. According to the
proposals, protecting the subsidization of these costs through
safe harbors could contribute to increased diversity, equity,
and inclusion in clinical trials.
21
New safe harbor to protect: (1) value-based price-adjustment OIG is not adopting this suggestion. We appreciate learning
arrangements that are dependent on the achievement of a about ways in which pharmaceutical manufacturers, medical
measurable clinical or cost outcome associated with the value device manufacturers, and DMEPOS entities believe that they
of a seller’s reimbursable items or services and (2) the could contribute to the coordination of care and the overall
provision of value-based services, such as services that enable delivery of high-value care for Federal health care program
parties to evaluate outcome measures associated with value- enrollees. However, we continue to have concerns about the
based price-adjustment arrangements. offer of remuneration by these entities, which raises many of the
traditional fraud and abuse risks under the Federal anti-kickback
statute. We may consider this topic in future rulemaking.
New safe harbors for: (1) travel, lodging, and associated OIG is not adopting these suggestions at this time. We may
expenses and (2) fertility preservation services furnished in consider this topic in future rulemaking.
connection with cellular and gene therapy treatments.
New safe harbors to protect value-based purchasing OIG is not adopting this suggestion. We continue to evaluate the
arrangements between pharmaceutical manufacturers and ways in which pharmaceutical manufacturers may be able to
payors. contribute to the coordination of care and the overall delivery of
high-value care through value-based arrangements, and we may
consider this topic in future rulemaking.
Modification to the patient engagement and support safe OIG is not adopting this suggestion, as we believe this safe
harbor, 42 C.F.R. § 1001.952(hh), to remove the requirement harbor offers sufficient flexibility to address the needs of various
that the availability of a tool or support not be determined in a patient populations (e.g., by providing a tool or support to
manner that takes into account the type of insurance coverage primarily a Medicaid population). In the 2020 OIG rulemaking
of the patient in order to address a perception that the establishing this safe harbor, Medicare and State Health Care
existing safe harbor does not sufficiently allow for the Programs: Fraud and Abuse; Revisions to Safe Harbors Under the
promotion of health equity or improvement in health Anti-Kickback Statute, and Civil Monetary Penalty Rules
outcomes for different patient populations. Regarding Beneficiary Inducements (the 2020 OIG Rulemaking),
we stated that: (1) it is possible that a particular tool or support
if offered on a neutral basis unrelated to payor type could result
in the provision of tools and supports primarily to Federal health
care program beneficiaries and (2) a value-based enterprise
could define its target patient population—and therefore limit
the scope of potential recipients of tools and supports—based
on individual or family income, which might overlap substantially
with Medicaid or dual-eligible populations but would not be
strictly determined based on an individual’s enrollment in
Medicaid or as dually eligible for both Medicare and Medicaid. 3
New safe harbor for Indian Health Care Providers (IHCPs) OIG is not adopting this suggestion. We may consider this topic
similar to the safe harbor for federally qualified health centers in future rulemaking. Although not specific to IHCPs, OIG
at 42 C.F.R. § 1001.952(w). believes existing regulations, and in particular, the new and
modified safe harbors that were finalized in the 2020 OIG
Rulemaking, may offer sufficient regulatory flexibility and can
facilitate innovative value-based and care coordination
arrangements for IHCPs.
3
OIG, “Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and
Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” 85 Fed. Reg. 77,684, 77,804 (Dec. 2, 2020).
22
Modifications to the safe harbors for value-based OIG is not adopting this suggestion. As explained in the 2020
arrangements, including the safe harbors for value-based OIG Rulemaking, remuneration exchanged by pharmaceutical
arrangements with substantial downside financial risk and full manufacturers and, in certain cases, DMEPOS entities, is not
financial risk, 42 C.F.R. § 1001.952(ff) and (gg), to protect the eligible for protection under the value-based arrangement safe
exchange of remuneration by entities that currently cannot harbors due to (among other reasons) concerns that such
use one or more of these safe harbors (e.g., pharmaceutical entities could use the safe harbors to protect arrangements that
manufacturers, manufacturers of a device or medical supply, are intended to market their products or inappropriately tether
entities or individuals that sell or rent DMEPOS [other than a clinicians to the use of a particular product. 4
pharmacy; a medical device or supply manufacturer that also
sells or rents DMEPOS; or a physician, provider, or other entity
that primarily furnishes services, all of whom remain eligible]).
Modifications to value-based arrangement safe harbors to OIG is not adopting this suggestion for modifications to the
provide greater clarity in the definitions, including the existing applicable safe harbors and definitions. The existing
definition of “value-based purpose.” regulations are intended to provide health care stakeholders
regulatory flexibility for certain value-based arrangements that
meet each element of an applicable safe harbor. In the event
additional clarity is needed, the advisory opinion process
remains available for parties to obtain a formal opinion on the
application of the Federal anti-kickback statute and safe harbor
provisions to a particular arrangement.
Modify the safe harbor for care coordination arrangements to OIG is not adopting these suggestions. We believe the safe
improve quality, health outcomes, and efficiency, 42 C.F.R. § harbor provides sufficient flexibility while balancing against fraud
1001.952(ee), to: (1) eliminate the requirement that and abuse risk.
remuneration be in-kind, (2) eliminate the requirement for
commercial reasonableness, (3) provide greater flexibility
regarding outcome measures, and (4) eliminate the 15 percent
contribution requirement.
Modify the full financial risk safe harbor to allow for OIG is not adopting this suggestion. The advisory opinion
protections when entities assume full financial risk for a subset process remains available for parties to obtain a formal opinion
of services or items. on the application of the Federal anti-kickback statute and safe
harbor provisions to a particular arrangement, including those
involving a subset of services or items.
New safe harbor for items and services furnished to address OIG is not adopting this suggestion. We may consider this topic
social determinants of health and to facilitate compliance with in future rulemaking. OIG recognizes the potential benefits that
Internal Revenue Service community benefit requirements for social determinants of health have for health and well-being.
not-for-profit hospitals. Existing regulations, including the safe harbor for arrangements
for patient engagement and support to improve quality, health
outcomes, and efficiency at 42 C.F.R. § 1001.952(hh), provide
regulatory flexibility for in-kind remuneration to enrollees to
address social determinants of health. Moreover, the advisory
opinion process remains available for parties to obtain a formal
opinion on the application of the anti-kickback statute and safe
harbor provisions to a particular arrangement involving items
and services furnished to address social determinants of health.
4
Id. at 77,782.
23
Appendix E: Peer Reviews
Peer reviews are conducted by member organizations of the Council of the Inspectors General on Integrity and
Efficiency (CIGIE). The CIGIE peer review program provides OIGs and their stakeholders with an assessment of
the OIG’s compliance with relevant quality standards and its quality control systems (e.g., policies and
procedures).
Office of Audit Services
During the reporting period, OIG’s Office of Audit Services (OAS) did not receive a peer review. The most
recent peer review OAS received was conducted by the Department of Housing and Urban Development
(HUD) OIG, the final report of which was issued in March 2024. In that review, OAS received a “pass” rating
and HUD-OIG issued no recommendations. OAS has no outstanding peer review recommendations. OAS
conducted a peer review of the Department of Defense (DOD) OIG during the reporting period, the final report
of which was issued September 2024.
Office of Evaluation and Inspections
During the reporting period, OIG’s Office of Evaluation and Inspections (OEI) did not receive a peer review.
The most recent peer review OEI received was conducted by the Department of Energy (DOE) OIG, the final
report of which was issued in February 2023. In that review, DOE-OIG determined that OEI’s policies and
procedures and the four reports reviewed generally were consistent and complied with the CIGIE Blue Book
standards. OEI has no outstanding peer review recommendations. OEI did not conduct a peer review during
the reporting period. The most recent per review OEI conducted was of the Special Inspector General for
Afghanistan Reconstruction OIG, the final report of which was issued in March 2023.
Office of Investigations
During the reporting period, the United States Postal Service (USPS) OIG conducted a peer review of OIG’s
Office of Investigations (OI), the final report of which is not yet issued as of December 2024. OI has no
outstanding peer review recommendations. OI did not conduct a peer review during the reporting period.
The most recent per review OI conducted was of the DOD-OIG, the final report of which was issued in
February 2023.
24
Appendix F: Reporting
Requirements
The National Defense Authorization Act (NDAA) of Fiscal Year 2023, section 5273, amended the Inspector
General Act of 1978 and the Inspector General Empowerment Act of 2016 to streamline semiannual reporting
requirements for offices of inspectors general, which now appear in the note of 5 U.S.C. § 405. The following
table presents the new NDAA requirements and other remaining requirements, along with the location of the
information in this report.
Section Requirement Location
U.S.C. § 405 (note)
5(a)(1) Significant problems, abuses, and deficiencies Throughout this report
5(a)(2) Recommendations for which corrective action has not been Introduction and OIG’s
completed Recommendations Tracker
5(a)(3) Significant investigations closed during the reporting period Throughout this report
5(a)(4) Convictions during the reporting period Appendix B: Investigative Actions
5(a)(5) Information regarding reports issued during the reporting period Appendix A: Audits and Evaluations
5(a)(6) Information regarding any management decision made during
the reporting period with respect to any report issued during a At a Glance: OIG Accomplishments
previous reporting period and OIG’s Recommendations Tracker
5(a)(7) Information required by the Federal Financial Management None this reporting period
Improvement Act of 1996
5(a)(8) Results of peer reviews of HHS-OIG conducted by other OIGs Appendix E: Peer Reviews
5(a)(9) Outstanding recommendations from peer reviews of HHS-OIG Appendix E: Peer Reviews
conducted by other OIGs
5(a)(10) Peer reviews of other OIGs conducted by HHS-OIG Appendix E: Peer Reviews
5(a)(11) Investigative statistical tables Appendix B: Investigative Actions
5(a)(12) Metrics description for investigative statistical tables Appendix B: Investigative Actions
5(a)(13) Investigations of senior Government employees Appendix B: Investigative Actions
5(a)(14) Description of whistleblower retaliation instances None this reporting period
5(a)(15) Description of attempts to interfere with OIG independence None this reporting period
5(a)(16) Descriptions of investigations of senior Government employees Appendix B: Investigative Actions
5(a)(16) Descriptions of nonpublic reports Appendix A: Audits and Evaluations
Other Requirements
NDAA 2008 section Significant contract audits Appendix A: Audits and Evaluations
845
Health Insurance Public proposals for new and modified safe harbors Appendix D: Safe Harbor Proposals
Portability and
Accountability Act
American Recovery Retaliation complaint investigations OIG decided not to conduct None this reporting period
and Reinvestment Act or continue during the period
section 1553
Executive Order 14074 No-knock entries None this reporting period
Trafficking Victims Investigations relating to trafficking in persons Appendix B: Investigative Actions
Prevention and
Protection
Reauthorization Act of
2022
25
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Report Fraud, Waste,
and Abuse
OIG Hotline Operations accepts tips and complaints from all sources about
potential fraud, waste, abuse, and mismanagement in HHS programs. Hotline
tips are incredibly valuable, and we appreciate your efforts to help us stamp
out fraud, waste, and abuse.
TIPS.HHS.GOV
Phone: 1-800-447-8477
TTY: 1-800-377-4950
Who Can Report?
Anyone who suspects fraud, waste, and abuse should report their concerns
to the OIG Hotline. OIG addresses complaints about misconduct and
mismanagement in HHS programs, fraudulent claims submitted to Federal
health care programs such as Medicare, abuse or neglect in nursing homes,
and many more. Learn more about complaints OIG investigates.
How Does It Help?
Every complaint helps OIG carry out its mission of overseeing HHS programs
and protecting the individuals they serve. By reporting your concerns to the
OIG Hotline, you help us safeguard taxpayer dollars and ensure the success of
our oversight efforts.
Who Is Protected?
Anyone may request confidentiality. The Privacy Act, the Inspector General
Act of 1978, and other applicable laws protect complainants. The Inspector
General Act states that the Inspector General shall not disclose the identity of
an HHS employee who reports an allegation or provides information without
the employee’s consent, unless the Inspector General determines that
disclosure is unavoidable during the investigation. By law, Federal employees
may not take or threaten to take a personnel action because of
whistleblowing or the exercise of a lawful appeal, complaint, or grievance
right. Non-HHS employees who report allegations may also specifically
request confidentiality.
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