Providing for Consideration of the Bill (H.R. 4176), the Bill (H.R. 5585) and the Bill (H.R. 7666)
Summary
House Report 117–381 is a report of the Committee on Rules, submitted by Ms. Ross, referred to the House Calendar and ordered to be printed June 21, 2022, on House Resolution 1191. The Committee, by a record vote of 9 to 4, reports the resolution with the recommendation that it be adopted. The resolution provides for consideration of H.R. 4176, the LGBTQI+ Data Inclusion Act, H.R. 5585, to establish the Advanced Research Projects Agency-Health, and H.R. 7666, to reauthorize certain mental health and substance use disorder programs, each under a structured rule. For H.R. 4176 it provides one hour of general debate and makes in order only amendments printed in the report.
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“Providing for Consideration of the Bill (H.R. 4176), the Bill (H.R. 5585) and the Bill (H.R. 7666).”
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117TH CONGRESS REPORT
" HOUSE OF REPRESENTATIVES !
2d Session 117–381
PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 4176) TO IMPROVE
FEDERAL POPULATION SURVEYS BY REQUIRING THE COLLECTION OF
VOLUNTARY, SELF-DISCLOSED INFORMATION ON SEXUAL ORIENTATION
AND GENDER IDENTITY IN CERTAIN SURVEYS, AND FOR OTHER PUR-
POSES; PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 5585) TO ES-
TABLISH THE ADVANCED RESEARCH PROJECTS AGENCY-HEALTH, AND
FOR OTHER PURPOSES; PROVIDING FOR CONSIDERATION OF THE BILL
(H.R. 7666) TO AMEND THE PUBLIC HEALTH SERVICE ACT TO REAU-
THORIZE CERTAIN PROGRAMS RELATING TO MENTAL HEALTH AND
SUBSTANCE USE DISORDERS, AND FOR OTHER PURPOSES; AND FOR
OTHER PURPOSES
JUNE 21, 2022.—Referred to the House Calendar and ordered to be printed
Ms. ROSS, from the Committee on Rules,
submitted the following
R E P O R T
[To accompany H. Res. 1191]
The Committee on Rules, having had under consideration House
Resolution 1191, by a record vote of 9 to 4, report the same to the
House with the recommendation that the resolution be adopted.
SUMMARY OF PROVISIONS OF THE RESOLUTION
The resolution provides for consideration of H.R. 4176, the
LGBTQI+ Data Inclusion Act, under a structured rule. The resolu-
tion provides one hour of general debate equally divided and con-
trolled by the chair and ranking minority member of the Com-
mittee on Oversight and Reform or their designees. The resolution
waives all points of order against consideration of the bill. The res-
olution provides that an amendment in the nature of a substitute
consisting of the text of Rules Committee Print 117–52, modified
by the amendment printed in part A of this report, shall be consid-
ered as adopted and the bill, as amended, shall be considered as
read. The resolution waives all points of order against provisions
in the bill, as amended.
The resolution makes in order only those further amendments to
H.R. 4176 printed in part B of this report. Each such amendment
may be offered only in the order printed in this report, may be of-
fered only by a Member designated in this report, shall be consid-
ered as read, shall be debatable for the time specified in the report
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equally divided and controlled by the proponent and an opponent,
29–008
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2
shall not be subject to amendment, and shall not be subject to a
demand for division of the question. The resolution waives all
points of order against the amendments printed in part B of the
report. The resolution provides for one motion to recommit. The
resolution provides for consideration of H.R. 5585, the Advanced
Research Projects Agency—Health Act, under a structured rule.
The resolution provides one hour of general debate on the bill
equally divided and controlled by the chair and ranking minority
member of the Committee on Energy and Commerce or their des-
ignees. The resolution waives all points of order against consider-
ation of the bill. The resolution provides that the amendment in
the nature of a substitute recommended by the Committee on En-
ergy and Commerce now printed in the bill shall be considered as
adopted and the bill, as amended, shall be considered as read. The
resolution waives all points of order against provisions in the bill,
as amended. The resolution makes in order the further amendment
to H.R. 5585 printed in part C of this report, if offered by the Mem-
ber designated in this report, which shall be considered as read,
shall be debatable for the time specified in the report equally di-
vided and controlled by the proponent and an opponent, and shall
not be subject to a demand for division of the question. The resolu-
tion waives all points of order against the amendment printed in
part C of this report. The resolution provides one motion to recom-
mit. The resolution also provides for consideration of H.R. 7666, the
Restoring Hope for Mental Health and Well-Being Act of 2022,
under a structured rule. The resolution provides one hour of gen-
eral debate on the bill equally divided and controlled by the chair
and ranking minority member of the Committee on Energy and
Commerce or their designees. The resolution waives all points of
order against consideration of the bill. The resolution provides that
an amendment in the nature of a substitute consisting of the text
of Rules Committee Print 117–51, modified by the amendment
printed in part D of this report, shall be considered as adopted and
the bill, as amended, shall be considered as read. The resolution
waives all points of order against provisions in the bill, as amend-
ed. The resolution provides that following debate, each further
amendment printed in part E of this report not earlier considered
as part of amendments en bloc pursuant to section 6 shall be con-
sidered only in the order printed in this report, may be offered only
by a Member designated in this report, shall be considered as read,
shall be debatable for the time specified in this report equally di-
vided and controlled by the proponent and an opponent, may be
withdrawn by the proponent at any time before the question is put
thereon, shall not be subject to amendment, and shall not be sub-
ject to a demand for division of the question. Section 6 of the reso-
lution provides that at any time after debate the chair of the Com-
mittee on Energy and Commerce or his designee may offer amend-
ments en bloc consisting of further amendments printed in part E
this report not earlier disposed of. Amendments en bloc shall be
considered as read, shall be debatable for 20 minutes equally di-
vided and controlled by the chair and ranking minority member of
the Committee on Energy and Commerce or their designees, shall
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not be subject to amendment, and shall not be subject to a demand
for division of the question. The resolution waives all points of
order against the amendments printed in part E of this report and
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3
amendments en bloc described in section 6 of the resolution. The
resolution provides one motion to recommit. The resolution pro-
vides that House Resolution 188, agreed to March 8, 2021 (as most
recently amended by House Resolution 1170, agreed to June 14,
2022), is amended by striking ‘‘June 22, 2022’’ each place it appears
and inserting (in each instance) ‘‘July 13, 2022’’. The resolution
provides that proceedings may be postponed through July 15, 2022,
on measures that were the object of motions to suspend the rules
on the legislative days of June 21, 2022, June 22, 2022, June 23,
2022, or June 24, 2022, and on which the yeas and nays were or-
dered.
EXPLANATION OF WAIVERS
The waiver of all points of order against consideration of H.R.
4176 includes a waiver of clause 3(d)(1) of rule XIII of the Congres-
sional Budget Act, which requires the inclusion of committee cost
estimate in a committee report. A CBO cost estimate on H.R. 4176
was not available at the time the Committee on the Oversight and
Reform filed its report.
Although the resolution waives all points of order against provi-
sions in H.R. 4176, as amended, the Committee is not aware of any
points of order. The waiver is prophylactic in nature.
Although the resolution waives all points of order against the
amendments to H.R. 4176 printed in part B of this report, the
Committee is not aware of any points of order. The waiver is pro-
phylactic in nature.
Although the resolution waives all points of order against consid-
eration of H.R. 5585, the Committee is not aware of any points of
order. The waiver is prophylactic in nature.
The waiver of all points of order against provisions in H.R. 5585,
as amended, includes a waiver of clause 4 of rule XXI, which pro-
hibits reporting a bill carrying an appropriation from a committee
not having jurisdiction to report an appropriation.
Although the resolution waives all points of order against the
amendment to H.R. 5585 printed in part C of this report, the Com-
mittee is not aware of any points of order. The waiver is prophy-
lactic in nature.
The waiver of all points of order against consideration of H.R.
7666 includes waivers of the following:
—Clause 10 of rule XXI, which prohibits consideration of a meas-
ure that has a net effect of increasing the deficit or reducing the
surplus over the five- or 10-year period; however, the budgetary ef-
fects of the bill are fully offset over the 10-year period.
—Section 302(f) of the Congressional Budget Act, which prohibits
consideration of a bill if it has the net effect of increasing manda-
tory spending over the five- or ten-year period.
The waiver of all points of order against provisions in H.R. 7666,
as amended, includes waivers of the following:
—Clause 4 of rule XXI, which prohibits reporting a bill carrying
an appropriation from a committee not having jurisdiction to report
an appropriation.
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—Clause 5(a) of rule XXI, which prohibits a bill or joint resolu-
tion carrying a tax or tariff measure from being reported by a com-
mittee not having jurisdiction to report tax or tariff measures.
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Although the resolution waives all points of order against the
amendments to H.R. 7666 printed in part E of this report and
amendments en bloc described in section 6 of the resolution, the
Committee is not aware of any points of order. The waiver is pro-
phylactic in nature.
COMMITTEE VOTES
The results of each record vote on an amendment or motion to
report, together with the names of those voting for and against, are
printed below:
Rules Committee record vote No. 240
Motion by Mr. Cole to add language to the rule that would elimi-
nate the ability to vote remotely by proxy. Defeated: 4–9
Majority Members Vote Minority Members Vote
Mrs. Torres ....................................................... Nay Mr. Cole ........................................................... Yea
Mr. Perlmutter .................................................. Nay Mr. Burgess ..................................................... Yea
Mr. Raskin ........................................................ Nay Mr. Reschenthaler ............................................ Yea
Ms. Scanlon ...................................................... Nay Mrs. Fischbach ................................................ Yea
Mr. Morelle ....................................................... Nay
Mr. DeSaulnier .................................................. Nay
Ms. Ross ........................................................... Nay
Mr. Neguse ....................................................... Nay
Mr. McGovern, Chairman ................................. Nay
Rules Committee record vote No. 241
Motion by Mr. Burgess to amend the rule to H.R. 5585 to make
in order amendment #2, offered by Rep. Burgess (TX), which would
ensure that nothing in this Act or the amendments made by this
Act shall be construed to impede or interfere in any way with the
innovation, development, or distribution of transformative health
technologies, including diagnostic tests for early disease detection
and intervention. Defeated: 4–9
Majority Members Vote Minority Members Vote
Mrs. Torres ....................................................... Nay Mr. Cole ........................................................... Yea
Mr. Perlmutter .................................................. Nay Mr. Burgess ..................................................... Yea
Mr. Raskin ........................................................ Nay Mr. Reschenthaler ............................................ Yea
Ms. Scanlon ...................................................... Nay Mrs. Fischbach ................................................ Yea
Mr. Morelle ....................................................... Nay
Mr. DeSaulnier .................................................. Nay
Ms. Ross ........................................................... Nay
Mr. Neguse ....................................................... Nay
Mr. McGovern, Chairman ................................. Nay
Rules Committee record vote No. 242
Motion by Ms. Ross to report the rule. Adopted: 9–4
Majority Members Vote Minority Members Vote
Mrs. Torres ....................................................... Yea Mr. Cole ........................................................... Nay
Mr. Perlmutter .................................................. Yea Mr. Burgess ..................................................... Nay
Mr. Raskin ........................................................ Yea Mr. Reschenthaler ............................................ Nay
Ms. Scanlon ...................................................... Yea Mrs. Fischbach ................................................ Nay
Mr. Morelle ....................................................... Yea
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Mr. DeSaulnier .................................................. Yea
Ms. Ross ........................................................... Yea
Mr. Neguse ....................................................... Yea
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Majority Members Vote Minority Members Vote
Mr. McGovern, Chairman ................................. Yea
SUMMARY OF THE AMENDMENT TO H.R. 4176 IN PART A CONSIDERED
AS ADOPTED
1. Maloney, Carolyn (NY): Adds a finding and makes technical
and conforming changes to the bill.
SUMMARY OF THE AMENDMENTS TO H.R. 4176 IN PART B MADE IN
ORDER
1. Jackson Lee (TX): Requires a report to Congress from the
Comptroller General about the impact of the implementation of
this Act on the provision of services to persons according to their
gender identity, sexual orientation, and variations in sex character-
istics. (10 minutes)
2. Maloney, Sean (NY): Clarifies that when applicable, federal
surveys should gather information from a knowledgeable proxy of
a deceased LGBTQI+ individual. (10 minutes)
3. Tlaib (MI): Requires agencies collecting information through a
covered survey to establish data standards and protocols for
anonymizing data collected and destroying personally-identifiable
information at the appropriate time, which cannot be later than 3
years after the date that the information was collected. (10 min-
utes)
SUMMARY OF THE AMENDMENT TO H.R. 5585 IN PART C MADE IN
ORDER
1. Eshoo (CA), Guthrie (KY): Clarifies organizational structure of
offices within ARPA–H, limits the amount of administrative fund-
ing that may be used to operate ARPA–H to 15%, removes the re-
quirement of Senate confirmation of Director, and clarifies ARPA–
H’s leasing authority. (10 minutes)
SUMMARY OF THE AMENDMENT TO H.R. 7666 IN PART D CONSIDERED
AS ADOPTED
1. Pallone (NJ), McMorris Rodgers (WA): Makes technical
changes and adds provisions from H.R. 7233 as reported out of the
Committee on Energy and Commerce. Includes provisions to in-
crease transparency of pharmacy benefit managers for plan spon-
sors related to prescription drug spending and requires NIH to ex-
amine the effects of modern technology and multimedia on youth.
SUMMARY OF THE AMENDMENTS TO H.R. 7666 IN PART E MADE IN
ORDER
1. Bera (CA), Fitzpatrick (PA): Adds the House passed Helping
Emergency Responders Overcome (HERO) Act, which establishes a
series of programs relating to the behavioral health of law enforce-
ment officers, first responders, 9–1–1 operators, and other public
safety officers and health care providers. (10 minutes)
2. Davis, Rodney (IL), Bilirakis (FL), O’Halleran (AZ), Wagner
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(MO), Kuster (NH): Adds the text of HR 2355, the Opioid Prescrip-
tion Verification Act of 2021, which encourages the expanded use
of electronic prescribing for opioids similar to the mandate for
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6
Medicare Part D opioid prescriptions under current law. Incentivize
states to maintain and fully utilize prescription drug monitoring
programs (PDMP) and requires the U.S. Department of Health and
Human Services (HHS) to work with the CDC, DEA, and FDA to
offer materials and guidance to pharmacists on how to verify the
identity patients to help facilitate safe and responsible opioid pre-
scriptions. (10 minutes)
3. Dean (PA), Spartz (IN), Scanlon (PA), Fitzpatrick (PA): In-
creases the time limit for health care providers to use and hold
long-acting injectable (LAI) buprenorphine, if received through a
specialty pharmacy, from 14 to 60 days. (10 minutes)
4. Demings (FL): Requires a report on the available mental
health and stress related resources or programs that are available
to law enforcement officers. The report shall include additional leg-
islative tools and authorities that may be helpful or necessary to
assist in assessing, monitoring, and improving the mental health of
law enforcement officers. (10 minutes)
5. Feenstra (IA): Requires the Behavioral Health Crisis Coordi-
nating Office to include the Veterans Crisis Line as an entity to
provide rapid post-crisis follow-up care. (10 minutes)
6. Ferguson (GA), Burgess (TX), Pappas (NH), Carter, Buddy
(GA), Costa (CA), Fitzpatrick (PA), McBath (GA): Requires the De-
partment of Health and Human Services (HHS) to develop best
practices for establishing behavioral intervention teams in edu-
cational settings. (10 minutes)
7. Gottheimer (NJ): Includes veterans as an eligible group for
mental health and substance abuse care. (10 minutes)
8. Griffith (VA): Sets January 1, 2024 as date of applicability for
Sec. 262 to allow states time to review and update state law, if de-
sired. (10 minutes)
9. Joyce, David (OH): Requires the Department of Defense to
carry out a two-year pilot program aimed at preventing suicides
amongst active duty members of the Armed Forces by pre-
downloading resources onto smart devices issued to members of the
Armed Forces and to provide training on the use of these resources.
(10 minutes)
10. Katko (NY), Napolitano (CA), Beyer (VA), Raskin (MD),
Cárdenas (CA), Fitzpatrick (PA): Adds the House-passed Suicide
Prevention Lifeline Improvement Act, which includes enhanced
funding for the National Suicide Prevention Lifeline, authorization
for HHS to develop and implement an enhanced quality assurance
plan for the suicide prevention hotline, improved data sharing with
the CDC, and a pilot program for innovative technologies for sui-
cide prevention. (10 minutes)
11. Kim (NJ), Davids (KS): Adds the text of the Synthetic Opioid
Danger Awareness Act, which requires HHS to conduct a public
education campaign about synthetic opioids (including fentanyl and
its analogues), disseminate information about synthetic opioids to
health care providers, and develop a training guide and webinar for
first responders and other individuals at high risk of exposure to
synthetic opioids that details measures to prevent exposure. (10
minutes)
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12. McKinley (WV), Dingell (MI): Amends the Controlled Sub-
stances Act to clarify the process for registrants to exercise due
diligence upon discovering a suspicious order. (10 minutes)
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7
13. Moore (WI): Add appropriate state, local, and tribal public of-
ficials administering programs that serve low-income pregnant and
postpartum individuals to the list of entities that the Secretary
should consult with in operating and maintaining the maternal
mental health hotline. (10 minutes)
14. Napolitano (CA), Katko (NY): Revises Project AWARE, which
is administered by the Substance Abuse and Mental Health Serv-
ices Administration, to provide comprehensive school-based mental
health services, including screening, treatment, and outreach pro-
grams. (10 minutes)
15. Pressley (MA): Requires HHS to administer a report to study
rates of suicidal behaviors among children and adolescents with
chronic illnesses, including substance use disorders, autoimmune
disorders and heritable blood disorders and to submit a report to
Congress on findings. (10 minutes)
16. Reschenthaler (PA), Morelle (NY), Wild (PA), Dean (PA): Re-
quires a study to determine the true costs of untreated serious
mental illness on families, health care systems, public housing, and
law enforcement in America. (10 minutes)
17. Trone (MD), Armstrong (ND), Sherrill (NJ): Authorizes State
Opioid Response (SOR) Grants and Tribal Opioid Response (TOR)
Grants for 5 years at $1.75 billion per year, with a 5% set-aside
for TOR. (10 minutes)
PART A—TEXT OF AMENDMENT TO H.R. 4176 CONSIDERED AS ADOPTED
Page 2, after line 2, insert the following:
(5) The integrity of the Federal statistical system relies on
the ability of agencies to determine the content of their statis-
tical surveys based on considerations of relevance, timeliness,
accuracy, objectivity, and ability to maintain confidentiality.
Page 2, line 9, insert ‘‘for statistical purposes’’ after ‘‘survey’’.
Page 2, beginning on line 11, strike ‘‘existing data sets to deter-
mine in which data sets’’ and insert ‘‘covered surveys to determine
in which surveys’’.
Page 2, line 24 insert ‘‘for any survey identified in paragraph (1)’’
after ‘‘sex characteristics’’.
Page 3, strike lines 13 through 16 and insert the following:
(2) WAIVER.—The statistical official (as described in section
314 of title 5, United States Code) of each agency, or the head
of the agency, for any agency that does not have a statistical
official, may waive the requirement under paragraph (1), on a
case-by-case basis, if the standards and policies in subsection
(c) can not be met, or if adding such information to the survey
would impair the ability of the agency to preserve the utility,
accuracy, or objectivity of the survey while also generating rel-
evant evidence about the LGBTQI+ community.
Page 3, beginning on line 22, strike ‘‘(d) APPLICABILITY.—’’ and
all that follows through ‘‘(1) CONSTRUCTION.—’’ and insert ‘‘(d) CON-
STRUCTION.—’’.
Page 4, strike lines 3 through 9.
Page 4, line 13, after ‘‘any individual’’ insert the following: ‘‘, or
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that is inconsistent with disclosure limitations established in any
other law’’.
Page 5, line 16, strike ‘‘observation or’’.
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PART B—TEXT OF AMENDMENTS TO H.R. 4176 MADE IN ORDER
1. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE JACKSON
LEE OF TEXAS OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES
Page 4, after line 9, insert the following (and redesignate the
subsequent subsections accordingly):
(e) REPORT.— Not later than 2 years after the date of the enact-
ment of this Act, the Comptroller General shall provide a report to
Congress on the implementation of the requirements of this Act by
agencies, including how the implementation of such requirements
by agencies affected the provision of services to persons according
to the gender identity, sexual orientation, and variations in sex
characteristics of the persons.
2. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE MALONEY
OF NEW YORK OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
Page 4, line 22, insert after ‘‘proxy’’ the following: ‘‘(including a
proxy of a deceased individual, if applicable)’’.
3. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE TLAIB OF
MICHIGAN OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES
Page 2, line 20, insert after ‘‘confidentiality’’ the following: ‘‘, in-
cluding protocols for anonymizing data collected and destroying
personally-identifiable information at the appropriate time and not
later than three years after the date on which the information is
collected’’.
PART C—TEXT OF AMENDMENT TO H.R. 5585 MADE IN ORDER
1. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE ESHOO OF
CALIFORNIA OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES
Page 3, line 13, strike ‘‘There is established’’ and insert the fol-
lowing:
(1) IN GENERAL.—There is established
Page 3, after line 23, insert the following:
(2) ORGANIZATION.—
(A) IN GENERAL.—There shall be within ARPA–H—
(i) an Office of the Director;
(ii) not more than 6 program offices; and
(iii) such special project offices as the Director may
establish.
(B) PROGRAM OFFICES DEDICATED TO RESEARCH AND DE-
VELOPMENT.—Not fewer than two-thirds of the program of-
fices of ARPA–H shall be exclusively dedicated to research
and development.
Page 6, line 16, strike ‘‘with the advice and consent of the Sen-
ate,’’.
Page 14, strike line 19, and all that follows through page 16, line
6, and insert the following:
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‘‘(3) UTILIZATION OF LEASE FUNDS.—The Director shall de-
posit amounts of cash consideration received for a lease en-
tered into under this subsection in the ‘Advanced Research
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9
Projects Agency for Health’ account as discretionary offsetting
collections, and such amounts shall be available only to the ex-
tent and in the amounts provided in advance in appropriations
Acts—
‘‘(A) to cover the full costs to ARPA–H in connection with
the lease;
‘‘(B) for maintenance, capital revitalization, and improve-
ments of the real property assets and related personal
property under the jurisdiction of the Director; and
‘‘(C) for maintenance, capital revitalization, and improve-
ments of the real property assets and related personal
property at the respective center or facility of ARPA–H en-
gaged in the lease, subject to the concurrence of the Direc-
tor.’’.
Page 26, lines 15 through 19, amend paragraph (3) to read as fol-
lows:
‘‘(3) not award any grants, cooperative agreements, contracts,
prizes, and other transactions to nondomestic recipients orga-
nized under the laws of a covered foreign country (as defined
in section 119C of the National Security Act of 1947); and
Page 34, lines 23 and 24, strike ‘‘There is authorized’’ and insert
the following:
(1) IN GENERAL.—To carry out this section, there is author-
ized
Page 35, after line 2 (but before the close quotation mark and
second period) insert the following:
(2) ADMINISTRATIVE EXPENSES.—Not more than 15 percent of
the amounts made available to carry out this section for any
fiscal year may be used for administrative expenses to operate
ARPA–H.
PART D—TEXT OF AMENDMENT TO H.R. 7666 CONSIDERED AS ADOPTED
Amend section 263 to read as follows:
SEC. 263. REQUIRING PRESCRIBERS OF CONTROLLED SUBSTANCES
TO COMPLETE TRAINING.
Section 303 of the Controlled Substances Act (21 U.S.C. 823) is
amended by adding at the end the following:
‘‘(l) REQUIRED TRAINING FOR PRESCRIBERS.—
‘‘(1) TRAINING REQUIRED.—As a condition on registration
under this section to dispense controlled substances in sched-
ule II, III, IV, or V, the Attorney General shall require any
qualified practitioner, beginning with the first applicable reg-
istration for the practitioner, to meet the following:
‘‘(A) If the practitioner is a physician (as defined under
section 1861(r) of the Social Security Act), the practitioner
meets one or more of the following conditions:
‘‘(i) The physician holds a board certification in ad-
diction psychiatry or addiction medicine from the
American Board of Medical Specialties.
‘‘(ii) The physician holds a board certification from
the American Board of Addiction Medicine.
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‘‘(iii) The physician holds a board certification in ad-
diction medicine from the American Osteopathic Asso-
ciation.
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10
‘‘(iv) The physician has, with respect to the treat-
ment and management of patients with opioid or other
substance use disorders, or the safe pharmacological
management of dental pain and screening, brief inter-
vention, and referral for appropriate treatment of pa-
tients with or at risk of developing opioid or other sub-
stance use disorders, completed not less than 8 hours
of training (through classroom situations, seminars at
professional society meetings, electronic communica-
tions, or otherwise) that is provided by—
‘‘(I) the American Society of Addiction Medicine,
the American Academy of Addiction Psychiatry,
the American Medical Association, the American
Osteopathic Association, the American Dental As-
sociation, the American Association of Oral and
Maxillofacial Surgeons, the American Psychiatric
Association, or any other organization accredited
by the Accreditation Council for Continuing Med-
ical Education (commonly known as the ‘ACCME’)
or the Commission on Dental Accreditation;
‘‘(II) any organization accredited by a State
medical society accreditor that is recognized by
the ACCME or the Commission on Dental Accredi-
tation;
‘‘(III) any organization accredited by the Amer-
ican Osteopathic Association to provide continuing
medical education; or
‘‘(IV) any organization approved by the Assist-
ant Secretary for Mental Health and Substance
Abuse, the ACCME, or the Commission on Dental
Accreditation.
‘‘(v) The physician graduated in good standing from
an accredited school of allopathic medicine, osteopathic
medicine, dental surgery, or dental medicine in the
United States during the 5-year period immediately
preceding the date on which the physician first reg-
isters or renews under this section and has success-
fully completed a comprehensive allopathic or osteo-
pathic medicine curriculum or accredited medical resi-
dency or dental surgery or dental medicine curriculum
that included not less than 8 hours of training on—
‘‘(I) treating and managing patients with opioid
and other substance use disorders, including the
appropriate clinical use of all drugs approved by
the Food and Drug Administration for the treat-
ment of a substance use disorder; or
‘‘(II) the safe pharmacological management of
dental pain and screening, brief intervention, and
referral for appropriate treatment of patients with
or at risk of developing opioid and other substance
use disorders.
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‘‘(B) If the practitioner is not a physician (as defined
under section 1861(r) of the Social Security Act), the prac-
titioner meets one or more of the following conditions:
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11
‘‘(i) The practitioner has completed not fewer than 8
hours of training with respect to the treatment and
management of patients with opioid or other sub-
stance use disorders (through classroom situations,
seminars at professional society meetings, electronic
communications, or otherwise) provided by the Amer-
ican Society of Addiction Medicine, the American
Academy of Addiction Psychiatry, the American Med-
ical Association, the American Osteopathic Associa-
tion, the American Nurses Credentialing Center, the
American Psychiatric Association, the American Asso-
ciation of Nurse Practitioners, the American Academy
of Physician Associates, or any other organization ap-
proved or accredited by the Assistant Secretary for
Mental Health and Substance Abuse or the Accredita-
tion Council for Continuing Medical Education.
‘‘(ii) The practitioner has graduated in good standing
from an accredited physician assistant school or ac-
credited school of advanced practice nursing in the
United States during the 5-year period immediately
preceding the date on which the practitioner first reg-
isters or renews under this section and has success-
fully completed a comprehensive physician assistant or
advanced practice nursing curriculum that included
not fewer than 8 hours of training on treating and
managing patients with opioid and other substance
use disorders, including the appropriate clinical use of
all drugs approved by the Food and Drug Administra-
tion for the treatment of a substance use disorder.
‘‘(2) ONE-TIME TRAINING.—
‘‘(A) IN GENERAL.—The Attorney General shall not re-
quire any qualified practitioner to complete the training
described in clause (iv) or (v) of paragraph (1)(A) or clause
(i) or (ii) of paragraph (1)(B) more than once.
‘‘(B) NOTIFICATION.—Not later than 90 days after the
date of the enactment of the Restoring Hope for Mental
Health and Well-Being Act of 2022, the Attorney General
shall provide to qualified practitioners a single written,
electronic notification of the training described in clauses
(iv) and (v) of paragraph (1)(A) or clauses (i) and (ii) of
paragraph (1)(B).
‘‘(3) RULE OF CONSTRUCTION.—Nothing in this subsection
shall be construed to preclude the use, by a qualified practi-
tioner, of training received pursuant to this subsection to sat-
isfy registration requirements of a State or for some other law-
ful purpose.
‘‘(4) DEFINITIONS.—In this section:
‘‘(A) FIRST APPLICABLE REGISTRATION.—The term ‘first
applicable registration’ means the first registration or re-
newal of registration by a qualified practitioner under this
section that occurs on or after the date that is 180 days
after the date of enactment of the Restoring Hope for Men-
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tal Health and Well-Being Act of 2022.
‘‘(B) QUALIFIED PRACTITIONER.—In this subsection, the
term ‘qualified practitioner’ means a practitioner who—
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12
‘‘(i) is licensed under State law to prescribe con-
trolled substances; and
‘‘(ii) is not solely a veterinarian.’’.
Page 150, after line 5, insert the following:
SEC. 312. REAUTHORIZATION OF MINORITY FELLOWSHIP PROGRAM.
Section 597(c) of the Public Health Service Act (42 U.S.C.
290ll(c)) is amended by striking ‘‘$12,669,000 for each of fiscal
years 2018 through 2022’’ and inserting ‘‘$25,000,000 for each of
fiscal years 2023 through 2027’’.
At the end of title IV, add the following new subtitle:
Subtitle D—Media and Mental Health
SEC. 431. STUDY ON THE EFFECTS OF SMARTPHONE AND SOCIAL
MEDIA USE ON ADOLESCENTS.
(a) IN GENERAL.—Not later than 1 year after the date of enact-
ment of this Act, the Secretary of Health and Human Services shall
conduct or support research on—
(1) smartphone and social media use by adolescents; and
(2) the effects of such use on—
(A) emotional, behavioral, and physical health and devel-
opment; and
(B) any disparities in the mental health outcomes of
rural, minority, and other underserved populations.
(b) REPORT.—Not later than 5 years after the date of enactment
of this Act, the Secretary of Health and Human Services shall sub-
mit to the Congress, and make publicly available, a report on the
findings of research under this section.
SEC. 432. RESEARCH ON THE HEALTH AND DEVELOPMENT EFFECTS
OF MEDIA ON INFANTS, CHILDREN, AND ADOLESCENTS.
Subpart 7 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285g et seq.) is amended by adding at the end the fol-
lowing:
‘‘SEC. 452H. RESEARCH ON THE HEALTH AND DEVELOPMENT EFFECTS
OF MEDIA ON INFANTS, CHILDREN, AND ADOLESCENTS.
‘‘(a) IN GENERAL.—The Director of the National Institutes of
Health, in coordination with or acting through the Director of the
Institute, shall conduct and support research and related activities
concerning the health and developmental effects of media on in-
fants, children, and adolescents, which may include the positive
and negative effects of exposure to and use of media, such as social
media, applications, websites, television, motion pictures, artificial
intelligence, mobile devices, computers, video games, virtual and
augmented reality, and other media formats as they become avail-
able. Such research shall attempt to better understand the rela-
tionships between media and technology use and individual dif-
ferences and characteristics of children and shall include longitu-
dinally designed studies to assess the impact of media on youth
over time. Such research shall include consideration of core areas
of child and adolescent health and development including the fol-
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lowing:
‘‘(1) COGNITIVE.—The role and impact of media use and expo-
sure in the development of children and adolescents within
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13
such cognitive areas as language development, executive func-
tioning, attention, creative problem solving skills, visual and
spatial skills, literacy, critical thinking, and other learning
abilities, and the impact of early technology use on develop-
mental trajectories.
‘‘(2) PHYSICAL.—The role and impact of media use and expo-
sure on children’s and adolescent’s physical development and
health behaviors, including diet, exercise, sleeping and eating
routines, and other areas of physical development.
‘‘(3) SOCIO-EMOTIONAL.—The role and impact of media use
and exposure on children’s and adolescents’ social-emotional
competencies, including self-awareness, self-regulation, social
awareness, relationship skills, empathy, distress tolerance, per-
ception of social cues, awareness of one’s relationship with the
media, and decision-making, as well as outcomes such as viola-
tions of privacy, perpetration of or exposure to violence, bul-
lying or other forms of aggression, depression, anxiety, sub-
stance use, misuse or disorder, and suicidal ideation/behavior
and self-harm.
‘‘(b) DEVELOPING RESEARCH AGENDA.—The Director of the Na-
tional Institutes of Health, in consultation with the Director of the
Institute, other appropriate national research institutes, acad-
emies, and centers, the Trans-NIH Pediatric Research Consortium,
and non-Federal experts as needed, shall develop a research agen-
da on the health and developmental effects of media on infants,
children, and adolescents to inform research activities under sub-
section (a). In developing such research agenda, the Director may
use whatever means necessary (such as scientific workshops and
literature reviews) to assess current knowledge and research gaps
in this area.
‘‘(c) RESEARCH PROGRAM.—In coordination with the Institute and
other national research institutes and centers, and utilizing the
National Institutes of Health’s process of scientific peer review, the
Director of the National Institutes of Health shall fund an ex-
panded research program on the health and developmental effects
of media on infants, children, and adolescents.
‘‘(d) REPORT TO CONGRESS.—Not later than 1 year after the date
of enactment of this Act, the Director of the National Institutes of
Health shall submit a report to Congress on the progress made in
gathering data and expanding research on the health and develop-
mental effects of media on infants, children, and adolescents in ac-
cordance with this section. Such report shall summarize the grants
and research funded, by year, under this section.’’.
At the end of the bill, add the following new titles:
TITLE V—MEDICAID AND CHIP
SEC. 501.
MEDICAID AND CHIP REQUIREMENTS FOR HEALTH
SCREENINGS AND REFERRALS FOR ELIGIBLE JUVENILES
IN PUBLIC INSTITUTIONS.
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(a) MEDICAID STATE PLAN REQUIREMENT.—Section 1902 of the
Social Security Act (42 U.S.C. 1396a) is amended—
(1) in subsection (a)(84)—
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14
(A) in subparagraph (A), by inserting ‘‘, subject to sub-
paragraph (D),’’ after ‘‘but’’;
(B) in subparagraph (B), by striking ‘‘and’’ at the end;
(C) in subparagraph (C), by adding ‘‘and’’ at the end; and
(D) by adding at the end the following new subpara-
graph:
‘‘(D) beginning on the first day of the first calendar quar-
ter that begins two years after the date of enactment of
this subparagraph, in the case of individuals who are eligi-
ble juveniles described in subsection (nn)(2), are within 30
days of the date on which such eligible juvenile is sched-
uled to be released from a public institution following adju-
dication, the State shall have in place a plan to ensure,
and in accordance with such plan, provide—
‘‘(i) for, in the 30 days prior to the release of such
an eligible juvenile from such public institution (or not
later than one week after release from the public insti-
tution), and in coordination with such institution—
‘‘(I) any screening or diagnostic service which
meets reasonable standards of medical and dental
practice, as determined by the State, or as indi-
cated as medically necessary, in accordance with
paragraphs (1)(A) and (5) of section 1905(r); and
‘‘(II) a mental health or other behavioral health
screening that is a screening service described
under section 1905(r)(1), or a diagnostic service
described under paragraph (5) of such section, if
such screening or diagnostic service was not other-
wise conducted pursuant to this clause;
‘‘(ii) for, not later than one week after release from
the public institution, referrals for such eligible juve-
nile to the appropriate care and services available
under the State plan (or waiver of such plan) in the
geographic region of the home or residence of such eli-
gible juvenile, based on such screenings; and
‘‘(iii) for, following the release of such eligible juve-
nile from such institution, not less than 30 days of tar-
geted case management services furnished by a pro-
vider in the geographic region of the home or resi-
dence of such eligible juvenile.’’; and
(2) in subsection (nn)(3), by striking ‘‘(30)’’ and inserting
‘‘(31)’’.
(b) AUTHORIZATION OF FEDERAL FINANCIAL PARTICIPATION.—The
subdivision (A) of section 1905(a) of the Social Security Act (42
U.S.C. 1396d(a)) following paragraph (31) of such section is amend-
ed by inserting ‘‘, or in the case of an eligible juvenile described in
section 1902(a)(84)(D) with respect to the screenings, diagnostic
services, referrals, and case management required under such sub-
paragraph (D)’’ after ‘‘(except as a patient in a medical institution’’.
(c) CHIP CONFORMING AMENDMENTS.—
(1) Section 2103(c) of the Social Security Act (42 U.S.C.
1397cc(c)) is amended by adding at the end the following new
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paragraph:
‘‘(12) REQUIRED COVERAGE OF SCREENINGS, DIAGNOSTIC SERV-
ICES, REFERRALS, AND CASE MANAGEMENT FOR CERTAIN INMATES
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15
PRE-RELEASE.—With respect to individuals described in section
2110(b)(7), the State shall provide screenings, diagnostic serv-
ices, referrals, and case management otherwise covered under
the State child health plan (or waiver of such plan) during the
period described in such section with respect to such
screenings, services, referrals, and case management.’’.
(2) Section 2110(b) of the Social Security Act (42 U.S.C.
1397jj(b)) is amended—
(A) in paragraph (2)(A), by inserting ‘‘except as provided
in paragraph (7),’’ before ‘‘a child who is an inmate of a
public institution’’; and
(B) by adding at the end the following new paragraph:
‘‘(7) EXCEPTION TO EXCLUSION OF CHILDREN WHO ARE IN-
MATES OF A PUBLIC INSTITUTION.—A child shall not be consid-
ered to be described in paragraph (2)(A) if such child is an eli-
gible juvenile (as described in section 1902(a)(84)(D)) with re-
spect to the screenings, diagnostic services, referrals, and case
management otherwise covered under the State child health
plan (or waiver of such plan) during the period with respect to
which such screenings, services, referrals, and case manage-
ment is respectively required under such section.’’.
SEC. 502. GUIDANCE ON REDUCING ADMINISTRATIVE BARRIERS TO
PROVIDING HEALTH CARE SERVICES IN SCHOOLS.
(a) IN GENERAL.—Not later than 12 months after the date of en-
actment of this Act, the Secretary of Health and Human Services
shall issue guidance to State Medicaid agencies, elementary and
secondary schools, and school-based health centers on reducing ad-
ministrative barriers to such schools and centers furnishing med-
ical assistance and obtaining payment for such assistance under ti-
tles XIX and XXI of the Social Security Act (42 U.S.C. 1396 et seq.,
1397aa et seq.).
(b) CONTENTS OF GUIDANCE.—The guidance issued pursuant to
subsection (a) shall—
(1) include revisions to the May 2003 Medicaid School-Based
Administrative Claiming Guide, the 1997 Medicaid and Schools
Technical Assistance Guide, and other relevant guidance in ef-
fect on the date of enactment of this Act;
(2) provide information on payment under titles XIX and XXI
of the Social Security Act (42 U.S.C. 1396 et seq., 1397aa et
seq.) for the provision of medical assistance, including such as-
sistance provided in accordance with an individualized edu-
cation program or under the policy described in the State Med-
icaid Director letter on payment for services issued on Decem-
ber 15, 2014 (#14-006);
(3) take into account reasons why small and rural local edu-
cation agencies may not provide medical assistance and pro-
vide information on best practices to encourage such agencies
to provide such assistance; and
(4) include best practices and examples of methods that
State Medicaid agencies and local education agencies have
used to pay for, and increase the availability of, medical assist-
ance.
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(c) DEFINITIONS.—In this Act:
(1) INDIVIDUALIZED EDUCATION PROGRAM.—The term ‘‘indi-
vidualized education program’’ has the meaning given such
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16
term in section 602(14) of the Individuals with Disabilities
Education Act (20 U.S.C. 1401(14)).
(2) SCHOOL-BASED HEALTH CENTER.—The term ‘‘school-based
health center’’ has the meaning given such term in section
2110(c)(9) of the Social Security Act (42 U.S.C. 1397jj(c)(9)),
and includes an entity that provides Medicaid-covered services
in school-based settings for which Federal financial participa-
tion is permitted.
SEC. 503. GUIDANCE TO STATES ON SUPPORTING PEDIATRIC BEHAV-
IORAL HEALTH SERVICES UNDER MEDICAID AND CHIP.
Not later than 18 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall issue guidance
to States on how to expand the provision of, and access to, behav-
ioral health services, including mental health services, for children
covered under State plans (or waivers of such plans) under title
XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or State
child health plans (or waivers of such plans) under title XXI of
such Act (42 U.S.C. 1397aa et seq.), including a description of best
practices for—
(1) expanding access to such services;
(2) expanding access to such services in underserved commu-
nities;
(3) flexibilities that States may offer for pediatric hospitals
and other pediatric behavioral health providers to expand ac-
cess to services; and
(4) recruitment and retention of providers of such services.
SEC. 504. ENSURING CHILDREN RECEIVE TIMELY ACCESS TO CARE.
(a) GUIDANCE TO STATES ON FLEXIBILITIES TO ENSURE PROVIDER
CAPACITY TO PROVIDE PEDIATRIC BEHAVIORAL HEALTH, INCLUDING
MENTAL HEALTH, CRISIS CARE.—Not later than 18 months after
the date of enactment of this Act, the Secretary of Health and
Human Services shall provide guidance to States on existing flexi-
bilities under State plans (or waivers of such plans) under title XIX
of the Social Security Act (42 U.S.C. 1396 et seq.), or State child
health plans under title XXI of such Act (42 U.S.C. 1397aa et seq.),
to support children experiencing a behavioral health crisis or in
need of intensive behavioral health, including mental health, serv-
ices.
(b) ENSURING CONSISTENT REVIEW AND STATE IMPLEMENTATION
OF EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT
SERVICES.—Section 1905(r) of the Social Security Act (42 U.S.C.
1396d(r)) is amended by adding at the end the following: ‘‘Not later
than January 1, 2025, and every 5 years thereafter, the Secretary
shall review implementation of the requirements of this subsection
by States, including such requirements relating to services pro-
vided by managed care organizations, prepaid inpatient health
plans, prepaid ambulatory health plans, and primary care case
managers, to identify and disseminate best practices for ensuring
comprehensive coverage of services, to identify gaps and defi-
ciencies in meeting Federal requirements, and to provide guidance
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to States on addressing identified gaps and disparities and meeting
Federal coverage requirements in order to ensure children have ac-
cess to health services.’’.
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17
SEC. 505. STRATEGIES TO INCREASE ACCESS TO TELEHEALTH UNDER
MEDICAID AND CHIP.
Not later than 1 year after the date of the enactment of this Act,
and in the event updates are available, once every five years there-
after, the Secretary of Health and Human Services shall update
guidance issued by the Centers for Medicare & Medicaid Services
to States, the State Medicaid & CHIP Telehealth Toolkit, or any
successor guidance, to describe strategies States may use to over-
come existing barriers and increase access to telehealth services
under the Medicaid program under title XIX of the Social Security
Act (42 U.S.C. 1396 et seq.) and the Children’s Health Insurance
Program under title XXI of such Act (42 U.S.C. 1397aa et seq.).
Such updated guidance shall include examples of and promising
practices regarding—
(1) telehealth delivery of covered services;
(2) recommended voluntary billing codes, modifiers, and
place-of-service designations for telehealth and other virtual
health care services;
(3) strategies States can use for the simplification or align-
ment of provider credentialing and enrollment protocols with
respect to telehealth across States, State Medicaid plans under
title XIX, State child health plans under title XXI, Medicaid
managed care organizations, prepaid inpatient health plans,
prepaid ambulatory health plans, and primary care case man-
agers, including during national public health emergencies;
and
(4) strategies States can use to integrate telehealth and
other virtual health care services into value-based health care
models.
SEC. 506. REMOVAL OF LIMITATIONS ON FEDERAL FINANCIAL PAR-
TICIPATION FOR INMATES WHO ARE ELIGIBLE JUVE-
NILES PENDING DISPOSITION OF CHARGES.
(a) MEDICAID.—
(1) IN GENERAL.—The subdivision (A) of section 1905(a) of
the Social Security Act (42 U.S.C. 1396d(a)) following para-
graph (31) of such section, as amended by section 501(b), is fur-
ther amended by inserting ‘‘, or, at the option of the State, for
an individual who is an eligible juvenile (as defined in section
1902(nn)(2)), while such individual is an inmate of a public in-
stitution (as defined in section 1902(nn)(3)) pending disposition
of charges’’ after ‘‘or in the case of an eligible juvenile described
in section 1902(a)(84)(D) with respect to the screenings, diag-
nostic services, referrals, and case management required under
such subparagraph (D)’’.
(2) CONFORMING.—Section 1902(a)(84)(A) of the Social Secu-
rity Act (42 U.S.C. 1396a(a)(84)(A)) is amended by inserting
‘‘(or in the case of a State electing the option described in the
subdivision (A) following paragraph (31) of section 1905(a),
during such period beginning after the disposition of charges
with respect to such individual)’’ after ‘‘is such an inmate’’.
(b) CHIP.—Section 2110(b)(7) of the Social Security Act (42
U.S.C. 13977jj(b)(7)), as added by section 501(c)(2)(B), is further
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amended by inserting ‘‘or, at the option of the State, for an indi-
vidual who is a juvenile, while such individual is an inmate of a
public institution pending disposition of charges’’ after ‘‘if such
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18
child is an eligible juvenile (as described in section 1902(a)(84)(D))
with respect to screenings, diagnostic services, referrals, and case
management otherwise covered under the State child health plan
(or waiver of such plan)’’.
(c) EFFECTIVE DATE.—The amendments made by this section
shall take effect on the first day of the first calendar quarter that
begins after the date that is 18 months after the date of enactment
of this Act and shall apply to items and services furnished for peri-
ods beginning on or after such date.
TITLE VI—MISCELLANEOUS
PROVISIONS
SEC. 601. DETERMINATION OF BUDGETARY EFFECTS.
The budgetary effects of this Act, for the purpose of complying
with the Statutory Pay-As-You-Go Act of 2010, shall be determined
by reference to the latest statement titled ‘‘Budgetary Effects of
PAYGO Legislation’’ for this Act, submitted for printing in the Con-
gressional Record by the Chairman of the House Budget Com-
mittee, provided that such statement has been submitted prior to
the vote on passage.
SEC. 602. OVERSIGHT OF PHARMACY BENEFIT MANAGER SERVICES.
(a) PHSA.—Title XXVII of the Public Health Service Act (42
U.S.C. 300gg et seq.) is amended—
(1) in part D (42 U.S.C. 300gg–111 et seq.), by adding at the
end the following new section:
‘‘SEC. 2799A–11. OVERSIGHT OF PHARMACY BENEFIT MANAGER SERV-
ICES.
‘‘(a) IN GENERAL.—For plan years beginning on or after January
1, 2024, a group health plan or health insurance issuer offering
group health insurance coverage or an entity or subsidiary pro-
viding pharmacy benefits management services on behalf of such a
plan or issuer shall not enter into a contract with a drug manufac-
turer, distributor, wholesaler, subcontractor, rebate aggregator, or
any associated third party that limits the disclosure of information
to plan sponsors in such a manner that prevents the plan or issuer,
or an entity or subsidiary providing pharmacy benefits manage-
ment services on behalf of a plan or issuer, from making the re-
ports described in subsection (b).
‘‘(b) REPORTS.—
‘‘(1) IN GENERAL.—For plan years beginning on or after Janu-
ary 1, 2024, not less frequently than once every 6 months, a
health insurance issuer offering group health insurance cov-
erage or an entity providing pharmacy benefits management
services on behalf of a group health plan or an issuer providing
group health insurance coverage shall submit to the plan spon-
sor (as defined in section 3(16)(B) of the Employee Retirement
Income Security Act of 1974) of such group health plan or
health insurance coverage a report in accordance with this sub-
section and make such report available to the plan sponsor in
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a machine-readable format. Each such report shall include,
with respect to the applicable group health plan or health in-
surance coverage—
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19
‘‘(A) as applicable, information collected from drug man-
ufacturers by such issuer or entity on the total amount of
copayment assistance dollars paid, or copayment cards ap-
plied, that were funded by the drug manufacturer with re-
spect to the participants and beneficiaries in such plan or
coverage;
‘‘(B) a list of each drug covered by such plan, issuer, or
entity providing pharmacy benefit management services
that was dispensed during the reporting period, including,
with respect to each such drug during the reporting pe-
riod—
‘‘(i) the brand name, chemical entity, and National
Drug Code;
‘‘(ii) the number of participants and beneficiaries for
whom the drug was filled during the plan year, the
total number of prescription fills for the drug (includ-
ing original prescriptions and refills), and the total
number of dosage units of the drug dispensed across
the plan year, including whether the dispensing chan-
nel was by retail, mail order, or specialty pharmacy;
‘‘(iii) the wholesale acquisition cost, listed as cost per
days supply and cost per pill, or in the case of a drug
in another form, per dose;
‘‘(iv) the total out-of-pocket spending by participants
and beneficiaries on such drug, including participant
and beneficiary spending through copayments, coin-
surance, and deductibles; and
‘‘(v) for any drug for which gross spending of the
group health plan or health insurance coverage ex-
ceeded $10,000 during the reporting period—
‘‘(I) a list of all other drugs in the same thera-
peutic category or class, including brand name
drugs and biological products and generic drugs or
biosimilar biological products that are in the same
therapeutic category or class as such drug; and
‘‘(II) the rationale for preferred formulary place-
ment of such drug in that therapeutic category or
class, if applicable;
‘‘(C) a list of each therapeutic category or class of drugs
that were dispensed under the health plan or health insur-
ance coverage during the reporting period, and, with re-
spect to each such therapeutic category or class of drugs,
during the reporting period—
‘‘(i) total gross spending by the plan, before manu-
facturer rebates, fees, or other manufacturer remu-
neration;
‘‘(ii) the number of participants and beneficiaries
who filled a prescription for a drug in that category or
class;
‘‘(iii) if applicable to that category or class, a descrip-
tion of the formulary tiers and utilization mechanisms
(such as prior authorization or step therapy) employed
SSpencer on DSK126QN23PROD with REPORTS
for drugs in that category or class;
‘‘(iv) the total out-of-pocket spending by participants
and beneficiaries, including participant and bene-
VerDate Sep 11 2014 05:11 Jun 22, 2022 Jkt 029008 PO 00000 Frm 00019 Fmt 6659 Sfmt 6602 E:\HR\OC\HR381.XXX HR381
20
ficiary spending through copayments, coinsurance, and
deductibles; and
‘‘(v) for each therapeutic category or class under
which 3 or more drugs are included on the formulary
of such plan or coverage—
‘‘(I) the amount received, or expected to be re-
ceived, from drug manufacturers in rebates, fees,
alternative discounts, or other remuneration—
‘‘(aa) that has been paid, or is to be paid, by
drug manufacturers for claims incurred dur-
ing the reporting period; or
‘‘(bb) that is related to utilization of drugs,
in such therapeutic category or class;
‘‘(II) the total net spending, after deducting re-
bates, price concessions, alternative discounts or
other remuneration from drug manufacturers, by
the health plan or health insurance coverage on
that category or class of drugs; and
‘‘(III) the net price per course of treatment or
single fill, such as a 30-day supply or 90-day sup-
ply, incurred by the health plan or health insur-
ance coverage and its participants and bene-
ficiaries, after manufacturer rebates, fees, and
other remuneration for drugs dispensed within
such therapeutic category or class during the re-
porting period;
‘‘(D) total gross spending on prescription drugs by the
plan or coverage during the reporting period, before re-
bates and other manufacturer fees or remuneration;
‘‘(E) total amount received, or expected to be received, by
the health plan or health insurance coverage in drug man-
ufacturer rebates, fees, alternative discounts, and all other
remuneration received from the manufacturer or any third
party, other than the plan sponsor, related to utilization of
drug or drug spending under that health plan or health in-
surance coverage during the reporting period;
‘‘(F) the total net spending on prescription drugs by the
health plan or health insurance coverage during the re-
porting period; and
‘‘(G) amounts paid directly or indirectly in rebates, fees,
or any other type of remuneration to brokers, consultants,
advisors, or any other individual or firm who referred the
group health plan’s or health insurance issuer’s business
to the pharmacy benefit manager.
‘‘(2) PRIVACY REQUIREMENTS.—Health insurance issuers of-
fering group health insurance coverage and entities providing
pharmacy benefits management services on behalf of a group
health plan shall provide information under paragraph (1) in
a manner consistent with the privacy, security, and breach no-
tification regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996,
SSpencer on DSK126QN23PROD with REPORTS
and shall restrict the use and disclosure of such information
according to such privacy regulations.
‘‘(3) DISCLOSURE AND REDISCLOSURE.—
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21
‘‘(A) LIMITATION TO BUSINESS ASSOCIATES.—A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates of
such plan as defined in section 160.103 of title 45, Code of
Federal Regulations (or successor regulations).
‘‘(B) CLARIFICATION REGARDING PUBLIC DISCLOSURE OF
INFORMATION.—Nothing in this section prevents a health
insurance issuer offering group health insurance coverage
or an entity providing pharmacy benefits management
services on behalf of a group health plan from placing rea-
sonable restrictions on the public disclosure of the informa-
tion contained in a report described in paragraph (1), ex-
cept that such issuer or entity may not restrict disclosure
of such report to the Department of Health and Human
Services, the Department of Labor, the Department of the
Treasury, or applicable State agencies.
‘‘(C) LIMITED FORM OF REPORT.—The Secretary shall de-
fine through rulemaking a limited form of the report under
paragraph (1) required of plan sponsors who are drug
manufacturers, drug wholesalers, or other direct partici-
pants in the drug supply chain, in order to prevent anti-
competitive behavior.
‘‘(4) REPORT TO GAO.—A health insurance issuer offering
group health insurance coverage or an entity providing phar-
macy benefits management services on behalf of a group health
plan shall submit to the Comptroller General of the United
States each of the first 4 reports submitted to a plan sponsor
under paragraph (1) with respect to such coverage or plan, and
other such reports as requested, in accordance with the privacy
requirements under paragraph (2), the disclosure and redisclo-
sure standards under paragraph (3), the standards specified
pursuant to paragraph (5), and such other information that the
Comptroller General determines necessary to carry out the
study under section 602(d) of the Restoring Hope for Mental
Health and Well-Being Act of 2022.
‘‘(5) STANDARD FORMAT.—Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for
health insurance issuers and entities required to submit re-
ports under paragraph (4) to submit such reports in a standard
format.
‘‘(c) ENFORCEMENT.—
‘‘(1) IN GENERAL.—The Secretary, in consultation with the
Secretary of Labor and the Secretary of the Treasury, shall en-
force this section.
‘‘(2) FAILURE TO PROVIDE TIMELY INFORMATION.—A health in-
surance issuer or an entity providing pharmacy benefit man-
agement services that violates subsection (a) or fails to provide
information required under subsection (b), or a drug manufac-
turer that fails to provide information under subsection
(b)(1)(A) in a timely manner, shall be subject to a civil mone-
tary penalty in the amount of $10,000 for each day during
which such violation continues or such information is not dis-
SSpencer on DSK126QN23PROD with REPORTS
closed or reported.
‘‘(3) FALSE INFORMATION.—A health insurance issuer, entity
providing pharmacy benefit management services, or drug
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22
manufacturer that knowingly provides false information under
this section shall be subject to a civil money penalty in an
amount not to exceed $100,000 for each item of false informa-
tion. Such civil money penalty shall be in addition to other
penalties as may be prescribed by law.
‘‘(4) PROCEDURE.—The provisions of section 1128A of the So-
cial Security Act, other than subsection (a) and (b) and the first
sentence of subsection (c)(1) of such section shall apply to civil
monetary penalties under this subsection in the same manner
as such provisions apply to a penalty or proceeding under sec-
tion 1128A of the Social Security Act.
‘‘(5) WAIVERS.—The Secretary may waive penalties under
paragraph (2), or extend the period of time for compliance with
a requirement of this section, for an entity in violation of this
section that has made a good-faith effort to comply with this
section.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall be
construed to permit a health insurance issuer, group health plan,
or other entity to restrict disclosure to, or otherwise limit the ac-
cess of, the Department of Health and Human Services to a report
described in subsection (b)(1) or information related to compliance
with subsection (a) by such issuer, plan, or entity.
‘‘(e) DEFINITION.—In this section, the term ‘wholesale acquisition
cost’ has the meaning given such term in section 1847A(c)(6)(B) of
the Social Security Act.’’; and
(2) in section 2723 (42 U.S.C. 300gg–22)—
(A) in subsection (a)—
(i) in paragraph (1), by inserting ‘‘(other than sub-
sections (a) and (b) of section 2799A–11)’’ after ‘‘part
D’’; and
(ii) in paragraph (2), by inserting ‘‘(other than sub-
sections (a) and (b) of section 2799A–11)’’ after ‘‘part
D’’; and
(B) in subsection (b)—
(i) in paragraph (1), by inserting ‘‘(other than sub-
sections (a) and (b) of section 2799A–11)’’ after ‘‘part
D’’;
(ii) in paragraph (2)(A), by inserting ‘‘(other than
subsections (a) and (b) of section 2799A–11)’’ after
‘‘part D’’; and
(iii) in paragraph (2)(C)(ii), by inserting ‘‘(other than
subsections (a) and (b) of section 2799A–11)’’ after
‘‘part D’’.
(b) ERISA.—
(1) IN GENERAL.—Subtitle B of title I of the Employee Retire-
ment Income Security Act of 1974 (29 U.S.C. 1021 et seq.) is
amended—
(A) in subpart B of part 7 (29 U.S.C. 1185 et seq.), by
adding at the end the following:
‘‘SEC. 726. OVERSIGHT OF PHARMACY BENEFIT MANAGER SERVICES.
‘‘(a) IN GENERAL.—For plan years beginning on or after January
1, 2024, a group health plan (or health insurance issuer offering
SSpencer on DSK126QN23PROD with REPORTS
group health insurance coverage in connection with such a plan) or
an entity or subsidiary providing pharmacy benefits management
services on behalf of such a plan or issuer shall not enter into a
VerDate Sep 11 2014 05:11 Jun 22, 2022 Jkt 029008 PO 00000 Frm 00022 Fmt 6659 Sfmt 6602 E:\HR\OC\HR381.XXX HR381
23
contract with a drug manufacturer, distributor, wholesaler, subcon-
tractor, rebate aggregator, or any associated third party that limits
the disclosure of information to plan sponsors in such a manner
that prevents the plan or issuer, or an entity or subsidiary pro-
viding pharmacy benefits management services on behalf of a plan
or issuer, from making the reports described in subsection (b).
‘‘(b) REPORTS.—
‘‘(1) IN GENERAL.—For plan years beginning on or after Janu-
ary 1, 2024, not less frequently than once every 6 months, a
health insurance issuer offering group health insurance cov-
erage or an entity providing pharmacy benefits management
services on behalf of a group health plan or an issuer providing
group health insurance coverage shall submit to the plan spon-
sor (as defined in section 3(16)(B)) of such group health plan
or group health insurance coverage a report in accordance with
this subsection and make such report available to the plan
sponsor in a machine-readable format. Each such report shall
include, with respect to the applicable group health plan or
health insurance coverage—
‘‘(A) as applicable, information collected from drug man-
ufacturers by such issuer or entity on the total amount of
copayment assistance dollars paid, or copayment cards ap-
plied, that were funded by the drug manufacturer with re-
spect to the participants and beneficiaries in such plan or
coverage;
‘‘(B) a list of each drug covered by such plan, issuer, or
entity providing pharmacy benefit management services
that was dispensed during the reporting period, including,
with respect to each such drug during the reporting pe-
riod—
‘‘(i) the brand name, chemical entity, and National
Drug Code;
‘‘(ii) the number of participants and beneficiaries for
whom the drug was filled during the plan year, the
total number of prescription fills for the drug (includ-
ing original prescriptions and refills), and the total
number of dosage units of the drug dispensed across
the plan year, including whether the dispensing chan-
nel was by retail, mail order, or specialty pharmacy;
‘‘(iii) the wholesale acquisition cost, listed as cost per
days supply and cost per pill, or in the case of a drug
in another form, per dose;
‘‘(iv) the total out-of-pocket spending by participants
and beneficiaries on such drug, including participant
and beneficiary spending through copayments, coin-
surance, and deductibles; and
‘‘(v) for any drug for which gross spending of the
group health plan or health insurance coverage ex-
ceeded $10,000 during the reporting period—
‘‘(I) a list of all other drugs in the same thera-
peutic category or class, including brand name
SSpencer on DSK126QN23PROD with REPORTS
drugs and biological products and generic drugs or
biosimilar biological products that are in the same
therapeutic category or class as such drug; and
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24
‘‘(II) the rationale for preferred formulary place-
ment of such drug in that therapeutic category or
class, if applicable;
‘‘(C) a list of each therapeutic category or class of drugs
that were dispensed under the health plan or health insur-
ance coverage during the reporting period, and, with re-
spect to each such therapeutic category or class of drugs,
during the reporting period—
‘‘(i) total gross spending by the plan, before manu-
facturer rebates, fees, or other manufacturer remu-
neration;
‘‘(ii) the number of participants and beneficiaries
who filled a prescription for a drug in that category or
class;
‘‘(iii) if applicable to that category or class, a descrip-
tion of the formulary tiers and utilization mechanisms
(such as prior authorization or step therapy) employed
for drugs in that category or class;
‘‘(iv) the total out-of-pocket spending by participants
and beneficiaries, including participant and bene-
ficiary spending through copayments, coinsurance, and
deductibles; and
‘‘(v) for each therapeutic category or class under
which 3 or more drugs are included on the formulary
of such plan or coverage—
‘‘(I) the amount received, or expected to be re-
ceived, from drug manufacturers in rebates, fees,
alternative discounts, or other remuneration—
‘‘(aa) that has been paid, or is to be paid, by
drug manufacturers for claims incurred dur-
ing the reporting period; or
‘‘(bb) that is related to utilization of drugs,
in such therapeutic category or class;
‘‘(II) the total net spending, after deducting re-
bates, price concessions, alternative discounts or
other remuneration from drug manufacturers, by
the health plan or health insurance coverage on
that category or class of drugs; and
‘‘(III) the net price per course of treatment or
single fill, such as a 30-day supply or 90-day sup-
ply, incurred by the health plan or health insur-
ance coverage and its participants and bene-
ficiaries, after manufacturer rebates, fees, and
other remuneration for drugs dispensed within
such therapeutic category or class during the re-
porting period;
‘‘(D) total gross spending on prescription drugs by the
plan or coverage during the reporting period, before re-
bates and other manufacturer fees or remuneration;
‘‘(E) total amount received, or expected to be received, by
the health plan or health insurance coverage in drug man-
SSpencer on DSK126QN23PROD with REPORTS
ufacturer rebates, fees, alternative discounts, and all other
remuneration received from the manufacturer or any third
party, other than the plan sponsor, related to utilization of
VerDate Sep 11 2014 05:11 Jun 22, 2022 Jkt 029008 PO 00000 Frm 00024 Fmt 6659 Sfmt 6602 E:\HR\OC\HR381.XXX HR381
25
drug or drug spending under that health plan or health in-
surance coverage during the reporting period;
‘‘(F) the total net spending on prescription drugs by the
health plan or health insurance coverage during the re-
porting period; and
‘‘(G) amounts paid directly or indirectly in rebates, fees,
or any other type of remuneration to brokers, consultants,
advisors, or any other individual or firm who referred the
group health plan’s or health insurance issuer’s business
to the pharmacy benefit manager.
‘‘(2) PRIVACY REQUIREMENTS.—Health insurance issuers of-
fering group health insurance coverage and entities providing
pharmacy benefits management services on behalf of a group
health plan shall provide information under paragraph (1) in
a manner consistent with the privacy, security, and breach no-
tification regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of 1996,
and shall restrict the use and disclosure of such information
according to such privacy regulations.
‘‘(3) DISCLOSURE AND REDISCLOSURE.—
‘‘(A) LIMITATION TO BUSINESS ASSOCIATES.—A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates of
such plan as defined in section 160.103 of title 45, Code of
Federal Regulations (or successor regulations).
‘‘(B) CLARIFICATION REGARDING PUBLIC DISCLOSURE OF
INFORMATION.—Nothing in this section prevents a health
insurance issuer offering group health insurance coverage
or an entity providing pharmacy benefits management
services on behalf of a group health plan from placing rea-
sonable restrictions on the public disclosure of the informa-
tion contained in a report described in paragraph (1), ex-
cept that such issuer or entity may not restrict disclosure
of such report to the Department of Health and Human
Services, the Department of Labor, the Department of the
Treasury, or applicable State agencies.
‘‘(C) LIMITED FORM OF REPORT.—The Secretary shall de-
fine through rulemaking a limited form of the report under
paragraph (1) required of plan sponsors who are drug
manufacturers, drug wholesalers, or other direct partici-
pants in the drug supply chain, in order to prevent anti-
competitive behavior.
‘‘(4) REPORT TO GAO.—A health insurance issuer offering
group health insurance coverage or an entity providing phar-
macy benefits management services on behalf of a group health
plan shall submit to the Comptroller General of the United
States each of the first 4 reports submitted to a plan sponsor
under paragraph (1) with respect to such coverage or plan, and
other such reports as requested, in accordance with the privacy
requirements under paragraph (2), the disclosure and redisclo-
sure standards under paragraph (3), the standards specified
pursuant to paragraph (5), and such other information that the
SSpencer on DSK126QN23PROD with REPORTS
Comptroller General determines necessary to carry out the
study under section 602(d) of the Restoring Hope for Mental
Health and Well-Being Act of 2022.
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26
‘‘(5) STANDARD FORMAT.—Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for
health insurance issuers and entities required to submit re-
ports under paragraph (4) to submit such reports in a standard
format.
‘‘(c) ENFORCEMENT.—
‘‘(1) IN GENERAL.—The Secretary, in consultation with the
Secretary of Health and Human Services and the Secretary of
the Treasury, shall enforce this section.
‘‘(2) FAILURE TO PROVIDE TIMELY INFORMATION.—A health in-
surance issuer or an entity providing pharmacy benefit man-
agement services that violates subsection (a) or fails to provide
information required under subsection (b), or a drug manufac-
turer that fails to provide information under subsection
(b)(1)(A) in a timely manner, shall be subject to a civil mone-
tary penalty in the amount of $10,000 for each day during
which such violation continues or such information is not dis-
closed or reported.
‘‘(3) FALSE INFORMATION.—A health insurance issuer, entity
providing pharmacy benefit management services, or drug
manufacturer that knowingly provides false information under
this section shall be subject to a civil money penalty in an
amount not to exceed $100,000 for each item of false informa-
tion. Such civil money penalty shall be in addition to other
penalties as may be prescribed by law.
‘‘(4) PROCEDURE.—The provisions of section 1128A of the So-
cial Security Act, other than subsection (a) and (b) and the first
sentence of subsection (c)(1) of such section shall apply to civil
monetary penalties under this subsection in the same manner
as such provisions apply to a penalty or proceeding under sec-
tion 1128A of the Social Security Act.
‘‘(5) WAIVERS.—The Secretary may waive penalties under
paragraph (2), or extend the period of time for compliance with
a requirement of this section, for an entity in violation of this
section that has made a good-faith effort to comply with this
section.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall be
construed to permit a health insurance issuer, group health plan,
or other entity to restrict disclosure to, or otherwise limit the ac-
cess of, the Department of Labor to a report described in subsection
(b)(1) or information related to compliance with subsection (a) by
such issuer, plan, or entity.
‘‘(e) DEFINITION.—In this section, the term ‘wholesale acquisition
cost’ has the meaning given such term in section 1847A(c)(6)(B) of
the Social Security Act.’’; and
(B) in section 502(b)(3) (29 U.S.C. 1132(b)(3)), by insert-
ing ‘‘(other than section 726)’’ after ‘‘part 7’’.
(2) CLERICAL AMENDMENT.—The table of contents in section
1 of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting after the item re-
lating to section 725 the following new item:
SSpencer on DSK126QN23PROD with REPORTS
‘‘Sec. 726. Oversight of pharmacy benefit manager services.’’.
(c) IRC.—
VerDate Sep 11 2014 05:11 Jun 22, 2022 Jkt 029008 PO 00000 Frm 00026 Fmt 6659 Sfmt 6602 E:\HR\OC\HR381.XXX HR381
27
(1) IN GENERAL.—Subchapter B of chapter 100 of the Inter-
nal Revenue Code of 1986 is amended by adding at the end the
following:
‘‘SEC. 9826. OVERSIGHT OF PHARMACY BENEFIT MANAGER SERVICES.
‘‘(a) IN GENERAL.—For plan years beginning on or after January
1, 2024, a group health plan or an entity or subsidiary providing
pharmacy benefits management services on behalf of such a plan
shall not enter into a contract with a drug manufacturer, dis-
tributor, wholesaler, subcontractor, rebate aggregator, or any asso-
ciated third party that limits the disclosure of information to plan
sponsors in such a manner that prevents the plan, or an entity or
subsidiary providing pharmacy benefits management services on
behalf of a plan, from making the reports described in subsection
(b).
‘‘(b) REPORTS.—
‘‘(1) IN GENERAL.—For plan years beginning on or after Janu-
ary 1, 2024, not less frequently than once every 6 months, an
entity providing pharmacy benefits management services on
behalf of a group health plan shall submit to the plan sponsor
(as defined in section 3(16)(B) of the Employee Retirement In-
come Security Act of 1974) of such group health plan a report
in accordance with this subsection and make such report avail-
able to the plan sponsor in a machine-readable format. Each
such report shall include, with respect to the applicable group
health plan—
‘‘(A) as applicable, information collected from drug man-
ufacturers by such entity on the total amount of copay-
ment assistance dollars paid, or copayment cards applied,
that were funded by the drug manufacturer with respect
to the participants and beneficiaries in such plan;
‘‘(B) a list of each drug covered by such plan or entity
providing pharmacy benefit management services that was
dispensed during the reporting period, including, with re-
spect to each such drug during the reporting period—
‘‘(i) the brand name, chemical entity, and National
Drug Code;
‘‘(ii) the number of participants and beneficiaries for
whom the drug was filled during the plan year, the
total number of prescription fills for the drug (includ-
ing original prescriptions and refills), and the total
number of dosage units of the drug dispensed across
the plan year, including whether the dispensing chan-
nel was by retail, mail order, or specialty pharmacy;
‘‘(iii) the wholesale acquisition cost, listed as cost per
days supply and cost per pill, or in the case of a drug
in another form, per dose;
‘‘(iv) the total out-of-pocket spending by participants
and beneficiaries on such drug, including participant
and beneficiary spending through copayments, coin-
surance, and deductibles; and
‘‘(v) for any drug for which gross spending of the
group health plan exceeded $10,000 during the report-
SSpencer on DSK126QN23PROD with REPORTS
ing period—
‘‘(I) a list of all other drugs in the same thera-
peutic category or class, including brand name
VerDate Sep 11 2014 05:11 Jun 22, 2022 Jkt 029008 PO 00000 Frm 00027 Fmt 6659 Sfmt 6602 E:\HR\OC\HR381.XXX HR381
28
drugs and biological products and generic drugs or
biosimilar biological products that are in the same
therapeutic category or class as such drug; and
‘‘(II) the rationale for preferred formulary place-
ment of such drug in that therapeutic category or
class, if applicable;
‘‘(C) a list of each therapeutic category or class of drugs
that were dispensed under the health plan during the re-
porting period, and, with respect to each such therapeutic
category or class of drugs, during the reporting period—
‘‘(i) total gross spending by the plan, before manu-
facturer rebates, fees, or other manufacturer remu-
neration;
‘‘(ii) the number of participants and beneficiaries
who filled a prescription for a drug in that category or
class;
‘‘(iii) if applicable to that category or class, a descrip-
tion of the formulary tiers and utilization mechanisms
(such as prior authorization or step therapy) employed
for drugs in that category or class;
‘‘(iv) the total out-of-pocket spending by participants
and beneficiaries, including participant and bene-
ficiary spending through copayments, coinsurance, and
deductibles; and
‘‘(v) for each therapeutic category or class under
which 3 or more drugs are included on the formulary
of such plan—
‘‘(I) the amount received, or expected to be re-
ceived, from drug manufacturers in rebates, fees,
alternative discounts, or other remuneration—
‘‘(aa) that has been paid, or is to be paid, by
drug manufacturers for claims incurred dur-
ing the reporting period; or
‘‘(bb) that is related to utilization of drugs,
in such therapeutic category or class;
‘‘(II) the total net spending, after deducting re-
bates, price concessions, alternative discounts or
other remuneration from drug manufacturers, by
the health plan on that category or class of drugs;
and
‘‘(III) the net price per course of treatment or
single fill, such as a 30-day supply or 90-day sup-
ply, incurred by the health plan and its partici-
pants and beneficiaries, after manufacturer re-
bates, fees, and other remuneration for drugs dis-
pensed within such therapeutic category or class
during the reporting period;
‘‘(D) total gross spending on prescription drugs by the
plan during the reporting period, before rebates and other
manufacturer fees or remuneration;
‘‘(E) total amount received, or expected to be received, by
SSpencer on DSK126QN23PROD with REPORTS
the health plan in drug manufacturer rebates, fees, alter-
native discounts, and all other remuneration received from
the manufacturer or any third party, other than the plan
VerDate Sep 11 2014 05:11 Jun 22, 2022 Jkt 029008 PO 00000 Frm 00028 Fmt 6659 Sfmt 6602 E:\HR\OC\HR381.XXX HR381
29
sponsor, related to utilization of drug or drug spending
under that health plan during the reporting period;
‘‘(F) the total net spending on prescription drugs by the
health plan during the reporting period; and
‘‘(G) amounts paid directly or indirectly in rebates, fees,
or any other type of remuneration to brokers, consultants,
advisors, or any other individual or firm who referred the
group health plan’s business to the pharmacy benefit man-
ager.
‘‘(2) PRIVACY REQUIREMENTS.—Entities providing pharmacy
benefits management services on behalf of a group health plan
shall provide information under paragraph (1) in a manner
consistent with the privacy, security, and breach notification
regulations promulgated under section 264(c) of the Health In-
surance Portability and Accountability Act of 1996, and shall
restrict the use and disclosure of such information according to
such privacy regulations.
‘‘(3) DISCLOSURE AND REDISCLOSURE.—
‘‘(A) LIMITATION TO BUSINESS ASSOCIATES.—A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates of
such plan as defined in section 160.103 of title 45, Code of
Federal Regulations (or successor regulations).
‘‘(B) CLARIFICATION REGARDING PUBLIC DISCLOSURE OF
INFORMATION.—Nothing in this section prevents an entity
providing pharmacy benefits management services on be-
half of a group health plan from placing reasonable restric-
tions on the public disclosure of the information contained
in a report described in paragraph (1), except that such en-
tity may not restrict disclosure of such report to the De-
partment of Health and Human Services, the Department
of Labor, the Department of the Treasury, or applicable
State agencies.
‘‘(C) LIMITED FORM OF REPORT.—The Secretary shall de-
fine through rulemaking a limited form of the report under
paragraph (1) required of plan sponsors who are drug
manufacturers, drug wholesalers, or other direct partici-
pants in the drug supply chain, in order to prevent anti-
competitive behavior.
‘‘(4) REPORT TO GAO.—An entity providing pharmacy benefits
management services on behalf of a group health plan shall
submit to the Comptroller General of the United States each
of the first 4 reports submitted to a plan sponsor under para-
graph (1) with respect to such plan, and other such reports as
requested, in accordance with the privacy requirements under
paragraph (2), the disclosure and redisclosure standards under
paragraph (3), the standards specified pursuant to paragraph
(5), and such other information that the Comptroller General
determines necessary to carry out the study under section
602(d) of the Restoring Hope for Mental Health and Well-Being
Act of 2022.
‘‘(5) STANDARD FORMAT.—Not later than June 1, 2023, the
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Secretary shall specify through rulemaking standards for enti-
ties required to submit reports under paragraph (4) to submit
such reports in a standard format.
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30
‘‘(c) ENFORCEMENT.—
‘‘(1) IN GENERAL.—The Secretary, in consultation with the
Secretary of Labor and the Secretary of Health and Human
Services, shall enforce this section.
‘‘(2) FAILURE TO PROVIDE TIMELY INFORMATION.—An entity
providing pharmacy benefit management services that violates
subsection (a) or fails to provide information required under
subsection (b), or a drug manufacturer that fails to provide in-
formation under subsection (b)(1)(A) in a timely manner, shall
be subject to a civil monetary penalty in the amount of $10,000
for each day during which such violation continues or such in-
formation is not disclosed or reported.
‘‘(3) FALSE INFORMATION.—An entity providing pharmacy
benefit management services, or drug manufacturer that know-
ingly provides false information under this section shall be
subject to a civil money penalty in an amount not to exceed
$100,000 for each item of false information. Such civil money
penalty shall be in addition to other penalties as may be pre-
scribed by law.
‘‘(4) PROCEDURE.—The provisions of section 1128A of the So-
cial Security Act, other than subsection (a) and (b) and the first
sentence of subsection (c)(1) of such section shall apply to civil
monetary penalties under this subsection in the same manner
as such provisions apply to a penalty or proceeding under sec-
tion 1128A of the Social Security Act.
‘‘(5) WAIVERS.—The Secretary may waive penalties under
paragraph (2), or extend the period of time for compliance with
a requirement of this section, for an entity in violation of this
section that has made a good-faith effort to comply with this
section.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall be
construed to permit a group health plan or other entity to restrict
disclosure to, or otherwise limit the access of, the Department of
the Treasury to a report described in subsection (b)(1) or informa-
tion related to compliance with subsection (a) by such plan or enti-
ty.
‘‘(e) DEFINITION.—In this section, the term ‘wholesale acquisition
cost’ has the meaning given such term in section 1847A(c)(6)(B) of
the Social Security Act.’’.
(2) CLERICAL AMENDMENT.—The table of sections for sub-
chapter B of chapter 100 of the Internal Revenue Code of 1986
is amended by adding at the end the following new item:
‘‘Sec. 9826. Oversight of pharmacy benefit manager services.’’.
(d) GAO STUDY.—
(1) IN GENERAL.—Not later than 3 years after the date of en-
actment of this Act, the Comptroller General of the United
States shall submit to Congress a report on—
(A) pharmacy networks of group health plans, health in-
surance issuers, and entities providing pharmacy benefit
management services under such group health plan or
group or individual health insurance coverage, including
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networks that have pharmacies that are under common
ownership (in whole or part) with group health plans,
health insurance issuers, or entities providing pharmacy
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31
benefit management services or pharmacy benefit adminis-
trative services under group health plan or group or indi-
vidual health insurance coverage;
(B) as it relates to pharmacy networks that include
pharmacies under common ownership described in sub-
paragraph (A)—
(i) whether such networks are designed to encourage
enrollees of a plan or coverage to use such pharmacies
over other network pharmacies for specific services or
drugs, and if so, the reasons the networks give for en-
couraging use of such pharmacies; and
(ii) whether such pharmacies are used by enrollees
disproportionately more in the aggregate or for specific
services or drugs compared to other network phar-
macies;
(C) whether group health plans and health insurance
issuers offering group or individual health insurance cov-
erage have options to elect different network pricing ar-
rangements in the marketplace with entities that provide
pharmacy benefit management services, the prevalence of
electing such different network pricing arrangements;
(D) pharmacy network design parameters that encour-
age enrollees in the plan or coverage to fill prescriptions
at mail order, specialty, or retail pharmacies that are
wholly or partially-owned by that issuer or entity; and
(E) the degree to which mail order, specialty, or retail
pharmacies that dispense prescription drugs to an enrollee
in a group health plan or health insurance coverage that
are under common ownership (in whole or part) with group
health plans, health insurance issuers, or entities pro-
viding pharmacy benefit management services or phar-
macy benefit administrative services under group health
plan or group or individual health insurance coverage re-
ceive reimbursement that is greater than the median price
charged to the group health plan or health insurance
issuer when the same drug is dispensed to enrollees in the
plan or coverage by other pharmacies included in the phar-
macy network of that plan, issuer, or entity that are not
wholly or partially owned by the health insurance issuer
or entity providing pharmacy benefit management serv-
ices.
(2) REQUIREMENT.—The Comptroller General of the United
States shall ensure that the report under paragraph (1) does
not contain information that would allow a reader to identify
a specific plan or entity providing pharmacy benefits manage-
ment services or otherwise contain commercial or financial in-
formation that is privileged or confidential.
(3) DEFINITIONS.—In this subsection, the terms ‘‘group
health plan’’, ‘‘health insurance coverage’’, and ‘‘health insur-
ance issuer’’ have the meanings given such terms in section
2791 of the Public Health Service Act (42 U.S.C. 300gg–91).
SEC. 603. MEDICARE IMPROVEMENT FUND.
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Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ‘‘$5,000,000’’ and inserting
‘‘$1,029,000,000’’.
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32
SEC. 604. LIMITATIONS ON AUTHORITY.
In carrying out any program of the Substance Abuse and Mental
Health Services Administration whose statutory authorization is
enacted or amended by this Act, the Secretary of Health and
Human Services shall not allocate funding, or require award recipi-
ents to prioritize, dedicate, or allocate funding, without consider-
ation of the incidence, prevalence, or determinants of mental health
or substance use issues, unless such allocation or requirement is
consistent with statute, regulation, or other Federal law.
PART E—TEXT OF AMENDMENTS TO H.R. 7666 MADE IN ORDER
1. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE BERA OF
CALIFORNIA OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
After section 331, insert the following new subtitle:
Subtitle E—Improving Emergency Depart-
ment Mental Health Access, Services,
and Responders
SEC. 341. HELPING EMERGENCY RESPONDERS OVERCOME.
(a) DATA SYSTEM TO CAPTURE NATIONAL PUBLIC SAFETY OFFICER
SUICIDE INCIDENCE.—The Public Health Service Act is amended by
inserting before section 318 of such Act (42 U.S.C. 247c) the fol-
lowing:
‘‘SEC. 317V. DATA SYSTEM TO CAPTURE NATIONAL PUBLIC SAFETY OF-
FICER SUICIDE INCIDENCE.
‘‘(a) IN GENERAL.—The Secretary, in coordination with the Direc-
tor of the Centers for Disease Control and Prevention and other
agencies as the Secretary determines appropriate, may—
‘‘(1) develop and maintain a data system, to be known as the
Public Safety Officer Suicide Reporting System, for the pur-
poses of—
‘‘(A) collecting data on the suicide incidence among pub-
lic safety officers; and
‘‘(B) facilitating the study of successful interventions to
reduce suicide among public safety officers; and
‘‘(2) integrate such system into the National Violent Death
Reporting System, so long as the Secretary determines such in-
tegration to be consistent with the purposes described in para-
graph (1).
‘‘(b) DATA COLLECTION.—In collecting data for the Public Safety
Officer Suicide Reporting System, the Secretary shall, at a min-
imum, collect the following information:
‘‘(1) The total number of suicides in the United States among
all public safety officers in a given calendar year.
‘‘(2) Suicide rates for public safety officers in a given cal-
endar year, disaggregated by—
‘‘(A) age and gender of the public safety officer;
‘‘(B) State;
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‘‘(C) occupation; including both the individual’s role in
their public safety agency and their primary occupation in
the case of volunteer public safety officers;
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33
‘‘(D) where available, the status of the public safety offi-
cer as volunteer, paid-on-call, or career; and
‘‘(E) status of the public safety officer as active or re-
tired.
‘‘(c) CONSULTATION DURING DEVELOPMENT.—In developing the
Public Safety Officer Suicide Reporting System, the Secretary shall
consult with non-Federal experts to determine the best means to
collect data regarding suicide incidence in a safe, sensitive, anony-
mous, and effective manner. Such non-Federal experts shall in-
clude, as appropriate, the following:
‘‘(1) Public health experts with experience in developing and
maintaining suicide registries.
‘‘(2) Organizations that track suicide among public safety of-
ficers.
‘‘(3) Mental health experts with experience in studying sui-
cide and other profession-related traumatic stress.
‘‘(4) Clinicians with experience in diagnosing and treating
mental health issues.
‘‘(5) Active and retired volunteer, paid-on-call, and career
public safety officers.
‘‘(6) Relevant national police, and fire and emergency med-
ical services, organizations.
‘‘(d) DATA PRIVACY AND SECURITY.—In developing and maintain-
ing the Public Safety Officer Suicide Reporting System, the Sec-
retary shall ensure that all applicable Federal privacy and security
protections are followed to ensure that—
‘‘(1) the confidentiality and anonymity of suicide victims and
their families are protected, including so as to ensure that data
cannot be used to deny benefits; and
‘‘(2) data is sufficiently secure to prevent unauthorized ac-
cess.
‘‘(e) REPORTING.—
‘‘(1) ANNUAL REPORT.—Not later than 2 years after the date
of enactment of the Restoring Hope for Mental Health and
Well-Being Act of 2022, and biannually thereafter, the Sec-
retary shall submit a report to the Congress on the suicide in-
cidence among public safety officers. Each such report shall—
‘‘(A) include the number and rate of such suicide inci-
dence, disaggregated by age, gender, and State of employ-
ment;
‘‘(B) identify characteristics and contributing cir-
cumstances for suicide among public safety officers;
‘‘(C) disaggregate rates of suicide by—
‘‘(i) occupation;
‘‘(ii) status as volunteer, paid-on-call, or career; and
‘‘(iii) status as active or retired;
‘‘(D) include recommendations for further study regard-
ing the suicide incidence among public safety officers;
‘‘(E) specify in detail, if found, any obstacles in collecting
suicide rates for volunteers and include recommended im-
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provements to overcome such obstacles;
‘‘(F) identify options for interventions to reduce suicide
among public safety officers; and
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34
‘‘(G) describe procedures to ensure the confidentiality
and anonymity of suicide victims and their families, as de-
scribed in subsection (d)(1).
‘‘(2) PUBLIC AVAILABILITY.—Upon the submission of each re-
port to the Congress under paragraph (1), the Secretary shall
make the full report publicly available on the website of the
Centers for Disease Control and Prevention.
‘‘(f) DEFINITION.—In this section, the term ‘public safety officer’
means—
‘‘(1) a public safety officer as defined in section 1204 of the
Omnibus Crime Control and Safe Streets Act of 1968; or
‘‘(2) a public safety telecommunicator as described in detailed
occupation 43–5031 in the Standard Occupational Classifica-
tion Manual of the Office of Management and Budget (2018).
‘‘(g) PROHIBITED USE OF INFORMATION.—Notwithstanding any
other provision of law, if an individual is identified as deceased
based on information contained in the Public Safety Officer Suicide
Reporting System, such information may not be used to deny or re-
scind life insurance payments or other benefits to a survivor of the
deceased individual.’’.
(b) PEER-SUPPORT BEHAVIORAL HEALTH AND WELLNESS PRO-
GRAMS WITHIN FIRE DEPARTMENTS AND EMERGENCY MEDICAL
SERVICE AGENCIES.—
(1) IN GENERAL.—Part B of title III of the Public Health
Service Act (42 U.S.C. 243 et seq.) is amended by adding at the
end the following:
‘‘SEC. 320C. PEER-SUPPORT BEHAVIORAL HEALTH AND WELLNESS
PROGRAMS WITHIN FIRE DEPARTMENTS AND EMER-
GENCY MEDICAL SERVICE AGENCIES.
‘‘(a) IN GENERAL.—The Secretary may award grants to eligible
entities for the purpose of establishing or enhancing peer-support
behavioral health and wellness programs within fire departments
and emergency medical services agencies.
‘‘(b) PROGRAM DESCRIPTION.—A peer-support behavioral health
and wellness program funded under this section shall—
‘‘(1) use career and volunteer members of fire departments or
emergency medical services agencies to serve as peer coun-
selors;
‘‘(2) provide training to members of career, volunteer, and
combination fire departments or emergency medical service
agencies to serve as such peer counselors;
‘‘(3) purchase materials to be used exclusively to provide
such training; and
‘‘(4) disseminate such information and materials as are nec-
essary to conduct the program.
‘‘(c) DEFINITION.—In this section:
‘‘(1) The term ‘eligible entity’ means a nonprofit organization
with expertise and experience with respect to the health and
life safety of members of fire and emergency medical services
agencies.
‘‘(2) The term ‘member’—
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‘‘(A) with respect to an emergency medical services agen-
cy, means an employee, regardless of rank or whether the
employee receives compensation (as defined in section
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35
1204(7) of the Omnibus Crime Control and Safe Streets
Act of 1968); and
‘‘(B) with respect to a fire department, means any em-
ployee, regardless of rank or whether the employee re-
ceives compensation, of a Federal, State, Tribal, or local
fire department who is responsible for responding to calls
for emergency service.’’.
(2) TECHNICAL CORRECTION.—Effective as if included in the
enactment of the Children’s Health Act of 2000 (Public Law
106–310), the amendment instruction in section 1603 of such
Act is amended by striking ‘‘Part B of the Public Health Serv-
ice Act’’ and inserting ‘‘Part B of title III of the Public Health
Service Act’’.
(c) HEALTH CARE PROVIDER BEHAVIORAL HEALTH AND WELLNESS
PROGRAMS.—Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.), as amended by subsection (b)(1), is further
amended by adding at the end the following:
‘‘SEC. 320D. HEALTH CARE PROVIDER BEHAVIORAL HEALTH AND
WELLNESS PROGRAMS.
‘‘(a) IN GENERAL.—The Secretary may award grants to eligible
entities for the purpose of establishing or enhancing behavioral
health and wellness programs for health care providers.
‘‘(b) PROGRAM DESCRIPTION.—A behavioral health and wellness
program funded under this section shall—
‘‘(1) provide confidential support services for health care pro-
viders to help handle stressful or traumatic patient-related
events, including counseling services and wellness seminars;
‘‘(2) provide training to health care providers to serve as peer
counselors to other health care providers;
‘‘(3) purchase materials to be used exclusively to provide
such training; and
‘‘(4) disseminate such information and materials as are nec-
essary to conduct such training and provide such peer coun-
seling.
‘‘(c) DEFINITIONS.—In this section, the term ‘eligible entity’
means a hospital, including a critical access hospital (as defined in
section 1861(mm)(1) of the Social Security Act) or a dispropor-
tionate share hospital (as defined under section 1923(a)(1)(A) of
such Act), a Federally-qualified health center (as defined in section
1905(1)(2)(B) of such Act), or any other health care facility.’’.
(d) DEVELOPMENT OF RESOURCES FOR EDUCATING MENTAL
HEALTH PROFESSIONALS ABOUT TREATING FIRE FIGHTERS AND
EMERGENCY MEDICAL SERVICES PERSONNEL.—
(1) IN GENERAL.—The Secretary of Health and Human Serv-
ices shall develop and make publicly available resources that
may be used by the Federal Government and other entities to
educate mental health professionals about—
(A) the culture of Federal, State, Tribal, and local career,
volunteer, and combination fire departments and emer-
gency medical services agencies;
(B) the different stressors experienced by firefighters
and emergency medical services personnel, supervisory
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firefighters and emergency medical services personnel, and
chief officers of fire departments and emergency medical
services agencies;
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36
(C) challenges encountered by retired firefighters and
emergency medical services personnel; and
(D) evidence-based therapies for mental health issues
common to firefighters and emergency medical services
personnel within such departments and agencies.
(2) CONSULTATION.—In developing resources under para-
graph (1), the Secretary of Health and Human Services shall
consult with national fire and emergency medical services or-
ganizations.
(3) DEFINITIONS.—In this subsection:
(A) The term ‘‘firefighter’’ means any employee, regard-
less of rank or whether the employee receives compensa-
tion, of a Federal, State, Tribal, or local fire department
who is responsible for responding to calls for emergency
service.
(B) The term ‘‘emergency medical services personnel’’
means any employee, regardless of rank or whether the
employee receives compensation, as defined in section
1204(7) of the Omnibus Crime Control and Safe Streets
Act of 1968 (34 U.S.C. 10284(7)).
(C) The term ‘‘chief officer’’ means any individual who is
responsible for the overall operation of a fire department
or an emergency medical services agency, irrespective of
whether such individual also serves as a firefighter or
emergency medical services personnel.
(e) BEST PRACTICES AND OTHER RESOURCES FOR ADDRESSING
POSTTRAUMATIC STRESS DISORDER IN PUBLIC SAFETY OFFICERS.—
(1) DEVELOPMENT; UPDATES.—The Secretary of Health and
Human Services shall—
(A) develop and assemble evidence-based best practices
and other resources to identify, prevent, and treat
posttraumatic stress disorder and co-occurring disorders in
public safety officers; and
(B) reassess and update, as the Secretary determines
necessary, such best practices and resources, including
based upon the options for interventions to reduce suicide
among public safety officers identified in the annual re-
ports required by section 317V(e)(1)(F) of the Public
Health Service Act, as added by subsection (a).
(2) CONSULTATION.—In developing, assembling, and updating
the best practices and resources under paragraph (1), the Sec-
retary of Health and Human Services shall consult with, at a
minimum, the following:
(A) Public health experts.
(B) Mental health experts with experience in studying
suicide and other profession-related traumatic stress.
(C) Clinicians with experience in diagnosing and treat-
ing mental health issues.
(D) Relevant national police, fire, and emergency med-
ical services organizations.
(3) AVAILABILITY.—The Secretary of Health and Human
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Services shall make the best practices and resources under
paragraph (1) available to Federal, State, and local fire, law
enforcement, and emergency medical services agencies.
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37
(4) FEDERAL TRAINING AND DEVELOPMENT PROGRAMS.—The
Secretary of Health and Human Services shall work with Fed-
eral departments and agencies, including the United States
Fire Administration, to incorporate education and training on
the best practices and resources under paragraph (1) into Fed-
eral training and development programs for public safety offi-
cers.
(5) DEFINITION.—In this subsection, the term ‘‘public safety
officer’’ means—
(A) a public safety officer as defined in section 1204 of
the Omnibus Crime Control and Safe Streets Act of 1968
(34 U.S.C. 10284); or
(B) a public safety telecommunicator as described in de-
tailed occupation 43–5031 in the Standard Occupational
Classification Manual of the Office of Management and
Budget (2018).
2. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE DAVIS OF
ILLINOIS OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
At the end of title II, add the following new subtitle:
Subtitle G—Opioid Epidemic Response
SEC. 271. OPIOID PRESCRIPTION VERIFICATION.
(a) MATERIALS FOR TRAINING PHARMACISTS ON CERTAIN CIR-
CUMSTANCES UNDER WHICH A PHARMACIST MAY DECLINE TO FILL
A PRESCRIPTION.—
(1) UPDATES TO MATERIALS.—Section 3212(a) of the SUP-
PORT for Patients and Communities Act (21 U.S.C. 829 note)
is amended by striking ‘‘Not later than 1 year after the date
of enactment of this Act, the Secretary of Health and Human
Services, in consultation with the Administrator of the Drug
Enforcement Administration, Commissioner of Food and
Drugs, Director of the Centers for Disease Control and Preven-
tion, and Assistant Secretary for Mental Health and Substance
Use, shall develop and disseminate’’ and inserting ‘‘The Sec-
retary of Health and Human Services, in consultation with the
Administrator of the Drug Enforcement Administration, Com-
missioner of Food and Drugs, Director of the Centers for Dis-
ease Control and Prevention, and Assistant Secretary for Men-
tal Health and Substance Use, shall develop and disseminate
not later than 1 year after the date of enactment of this Act,
and update periodically thereafter’’.
(2) MATERIALS INCLUDED.—Section 3212(b) of the SUPPORT
for Patients and Communities Act (21 U.S.C. 829 note) is
amended—
(A) by redesignating paragraphs (1) and (2) as para-
graphs (2) and (3), respectively; and
(B) by inserting before paragraph (2), as so redesignated,
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the following new paragraph:
‘‘(1) pharmacists on how to verify the identity of the pa-
tient;’’.
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38
(3) MATERIALS FOR TRAINING ON PATIENT VERIFICATION .—
Section 3212 of the SUPPORT for Patients and Communities
Act (21 U.S.C. 829 note) is amended by adding at the end the
following new subsection:
‘‘(d) MATERIALS FOR TRAINING ON VERIFICATION OF IDENTITY.—
Not later than 1 year after the date of enactment of this sub-
section, the Secretary of Health and Human Services, after seeking
stakeholder input in accordance with subsection (c), shall—
‘‘(1) update the materials developed under subsection (a) to
include information for pharmacists on how to verify the iden-
tity the patient; and
‘‘(2) disseminate, as appropriate, the updated materials.’’.
(b) INCENTIVIZING STATES TO FACILITATE RESPONSIBLE, IN-
FORMED DISPENSING OF CONTROLLED SUBSTANCES.—
(1) IN GENERAL.—Section 392A of the Public Health Service
Act (42 U.S.C. 280b–1) is amended—
(A) by redesignating subsections (c) and (d) as sub-
sections (d) and (e), respectively; and
(B) by inserting after subsection (b) the following new
subsection:
‘‘(c) PREFERENCE.—In determining the amounts of grants award-
ed to States under subsections (a) and (b), the Director of the Cen-
ters for Disease Control and Prevention may give preference to
States in accordance with such criteria as the Director may specify
and may choose to give preference to States that—
‘‘(1) maintain a prescription drug monitoring program;
‘‘(2) require prescribers of controlled substances in schedule
II, III, or IV to issue such prescriptions electronically, and
make such requirement subject to exceptions in the cases listed
in section 1860D–4(e)(7)(B) of the Social Security Act; and
‘‘(3) require dispensers of such controlled substances to enter
certain information about the purchase of such controlled sub-
stances into the respective State’s prescription drug monitoring
program, including—
‘‘(A) the National Drug Code or, in the case of com-
pounded medications, compound identifier;
‘‘(B) the quantity dispensed;
‘‘(C) the patient identifier; and
‘‘(D) the date filled.’’.
(2) DEFINITIONS.—
(A) IN GENERAL.—Subsection (d) of section 392A of the
Public Health Service Act (42 U.S.C. 280b–1), as redesig-
nated by paragraph (1)(A), is amended to read as follows:
‘‘(d) DEFINITIONS.—In this section:
‘‘(1) CONTROLLED SUBSTANCE.—The term ‘controlled sub-
stance’ has the meaning given that term in section 102 of the
Controlled Substances Act.
‘‘(2) DISPENSER.—The term ‘dispenser’ means a physician,
pharmacist, or other person that dispenses a controlled sub-
stance to an ultimate user.
‘‘(3) INDIAN TRIBE.—The term ‘Indian Tribe’ has the meaning
given that term in section 4 of the Indian Self-Determination
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and Education Assistance Act.’’.
(B) CONFORMING CHANGE.—Section 392A of the Public
Health Service Act (42 U.S.C. 280b–1) is amended by
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39
striking ‘‘Indian tribes’’ each place it appears and inserting
‘‘Indian Tribes’’.
3. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE DEAN OF
PENNSYLVANIA OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES
After section 263, insert the following new section:
SEC. 264. INCREASE IN NUMBER OF DAYS BEFORE WHICH CERTAIN
CONTROLLED SUBSTANCES MUST BE ADMINISTERED.
Section 309A(a)(5) of the Controlled Substances Act (21 U.S.C.
829a(a)(5)) is amended by striking ‘‘14 days’’ and inserting ‘‘60
days’’.
4. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE DEMINGS
OF FLORIDA OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES
At the end of title III, add the following new subtitle:
Subtitle E—Other Provisions
SEC. 341. REPORT ON LAW ENFORCEMENT MENTAL HEALTH AND
WELLNESS.
(a) IN GENERAL.—Not later than 270 days after the date of enact-
ment of this Act, the Attorney General, in consultation with the Di-
rector of the Federal Bureau of Investigation, the Director of the
National Institute for Justice, and the Assistant Secretary for Men-
tal Health and Substance Abuse, shall submit to the Committee on
Health, Education, Labor, and Pensions and the Committee on the
Judiciary of the Senate and the Committee on Energy and Com-
merce and the Committee on the Judiciary of the House of Rep-
resentatives a report on—
(1) the types, frequency, and severity of mental health and
stress-related responses of law enforcement officers to aggres-
sive actions or other trauma-inducing incidents against law en-
forcement officers;
(2) mental health and stress-related resources or programs
that are available to law enforcement officers at the Federal,
State, and local level, including peer-to-peer programs;
(3) the extent to which law enforcement officers use the re-
sources or programs described in paragraph (2);
(4) the availability of, or need for, mental health screening
within Federal, State, and local law enforcement agencies; and
(5) recommendations for Federal, State, and local law en-
forcement agencies to improve the mental health and wellness
of their officers.
(b) DEVELOPMENT.—In developing the report required under sub-
section (a), the Attorney General, the Director of the Federal Bu-
reau of Investigation, the Director of the National Institute of Jus-
tice, and the Assistant Secretary for Mental Health and Substance
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Abuse shall consult relevant stakeholders, including—
(1) Federal, State, Tribal and local law enforcement agencies;
and
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40
(2) nongovernmental organizations, international organiza-
tions, academies, or other entities.
5. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE FEENSTRA
OF IOWA OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
Page 5, after line 21, insert the following new subparagraph (and
redesignate the subsequent subparagraphs accordingly):
‘‘(B) the Veterans Crisis Line;
6. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE FERGUSON
OF GEORGIA OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
At the end of subtitle A of title IV, add the following new section:
SEC. 403. BEST PRACTICES FOR BEHAVIORAL INTERVENTION TEAMS.
The Public Health Service Act is amended by inserting after sec-
tion 520H of such Act, as added by section 151, the following new
section:
‘‘SEC. 520I.BEST PRACTICES FOR BEHAVIORAL INTERVENTION
TEAMS.
‘‘(a) IN GENERAL.—The Secretary shall identify and facilitate the
development of best practices to assist elementary schools, sec-
ondary schools, and institutions of higher education in establishing
and using behavioral intervention teams.
‘‘(b) ELEMENTS.—The best practices under subsection (a)(1) shall
include guidance on the following:
‘‘(1) How behavioral intervention teams can operate effec-
tively from an evidence-based, objective perspective while pro-
tecting the constitutional and civil rights of individuals.
‘‘(2) The use of behavioral intervention teams to identify con-
cerning behaviors, implement interventions, and manage risk
through the framework of the school’s or institution’s rules or
code of conduct, as applicable.
‘‘(3) How behavioral intervention teams can, when assessing
an individual—
‘‘(A) access training on evidence-based, threat-assess-
ment rubrics;
‘‘(B) ensure that such teams—
‘‘(i) have trained, diverse stakeholders with varied
expertise; and
‘‘(ii) use cross validation by a wide-range of indi-
vidual perspectives on the team; and
‘‘(C) use violence risk assessment.
‘‘(4) How behavioral intervention teams can help mitigate—
‘‘(A) inappropriate use of a mental health assessment;
‘‘(B) inappropriate limitations or restrictions on law en-
forcement’s jurisdiction over criminal matters;
‘‘(C) attempts to substitute the behavioral intervention
process in place of a criminal process, or impede a criminal
process, when an individual’s behavior has potential crimi-
nal implications;
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‘‘(D) endangerment of an individual’s privacy by failing
to ensure that all applicable Federal and State privacy
laws are fully complied with; or
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41
‘‘(E) inappropriate referrals to, or involvement of, law en-
forcement when an individual’s behavior does not warrant
a criminal response.
‘‘(c) CONSULTATION.—In carrying out subsection (a)(1), the Sec-
retary shall consult with—
‘‘(1) the Secretary of Education;
‘‘(2) the Director of the National Threat Assessment Center
of the United States Secretary Service;
‘‘(3) the Attorney General and the Director of the Bureau of
Justice Assistance;
‘‘(4) teachers and other educators, principals, school adminis-
trators, school board members, school psychologists, mental
health professionals, and parents of students;
‘‘(5) local law enforcement agencies and campus law enforce-
ment administrators;
‘‘(6) privacy experts; and
‘‘(7) other education and mental health professionals as the
Secretary deems appropriate.
‘‘(d) PUBLICATION.—Not later than 2 years after the date of en-
actment of this section, the Secretary shall publish the best prac-
tices under subsection (a)(1) on the internet website of the Depart-
ment of Health and Human Services.
‘‘(e) TECHNICAL ASSISTANCE.—The Secretary shall provide tech-
nical assistance to institutions of higher education, elementary
schools, and secondary schools to assist such institutions and
schools in implementing the best practices under subsection (a).
‘‘(f) DEFINITIONS.—In this section:
‘‘(1) The term ‘behavioral intervention team’ means a team
of qualified individuals who—
‘‘(A) are responsible for identifying and assessing indi-
viduals exhibiting concerning behaviors, experiencing dis-
tress, or who are at risk of harm to self or others;
‘‘(B) develop and facilitate implementation of evidence-
based interventions to mitigate the threat of harm to self
or others posed by an individual and address the mental
and behavioral health needs of individuals to reduce risk;
and
‘‘(C) provide information to students, parents, and school
employees on recognizing behavior described in this sub-
section.
‘‘(2) The terms ‘elementary school’, ‘parent’, and ‘secondary
school’ have the meanings given to such terms in section 8101
of the Elementary and Secondary Education Act of 1965.
‘‘(3) The term ‘institution of higher education’ has the mean-
ing given to such term in section 102 of the Higher Education
Act of 1965.
‘‘(4) The term ‘mental health assessment’ means an evalua-
tion, primarily focused on diagnosis, determining the need for
involuntary commitment, medication management, and on-
going treatment recommendations.
‘‘(5) The term ‘violence risk assessment’ means a broad deter-
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mination of the potential risk of violence based on evidence-
based literature.’’.
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42
7. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE
GOTTHEIMER OF NEW JERSEY OR HIS DESIGNEE, DEBATABLE FOR
10 MINUTES
Page 9, line 22, insert ‘‘veterans,’’ after ‘‘minorities,’’.
8. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE GRIFFITH
OF VIRGINIA OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
Page 130, after line 3, insert the following:
(c) APPLICABILITY.—The amendments made by this section shall
not apply until January 1, 2024.
9. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE JOYCE OF
OHIO OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
At the end of title I, add the following new subtitle:
Subtitle G—Military Suicide Prevention in
the 21st Century
SEC. 155. PILOT PROGRAM ON PRE-PROGRAMMING OF SUICIDE PRE-
VENTION RESOURCES INTO SMART DEVICES ISSUED TO
MEMBERS OF THE ARMED FORCES.
(a) IN GENERAL.—Commencing not later than 120 days after the
date of the enactment of this Act, the Secretary of Defense shall
carry out a pilot program under which the Secretary—
(1) pre-downloads the Virtual Hope Box application of the
Defense Health Agency, or such successor application, on
smart devices individually issued to members of the Armed
Forces;
(2) pre-programs the National Suicide Hotline number and
Veterans Crisis Line number into the contacts for such devices;
and
(3) provides training, as part of training on suicide aware-
ness and prevention conducted throughout the Department of
Defense, on the preventative resources described in paragraphs
(1) and (2).
(b) DURATION.—The Secretary shall carry out the pilot program
under this section for a two-year period.
(c) SCOPE.—The Secretary shall determine the appropriate scope
of individuals participating in the pilot program under this section
to best represent each Armed Force and to ensure a relevant sam-
ple size.
(d) IDENTIFICATION OF OTHER RESOURCES.—In carrying out the
pilot program under this section, the Secretary shall coordinate
with the Director of the Defense Health Agency and the Secretary
of Veterans Affairs to identify other useful technology-related re-
sources for use in the pilot program.
(e) REPORT.—Not later than 30 days after completing the pilot
program under this section, the Secretary shall submit to the Com-
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mittee on Armed Services of the Senate and the Committee on
Armed Services of the House of Representatives a report on the
pilot program.
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43
(f) VETERANS CRISIS LINE DEFINED.—In this section, the term
‘‘Veterans Crisis Line’’ means the toll-free hotline for veterans es-
tablished under section 1720F(h) of title 38, United States Code.
10. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE KATKO OF
NEW YORK OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
After section 102, insert the following new section:
SEC. 103. SUICIDE PREVENTION LIFELINE IMPROVEMENT.
(a) SUICIDE PREVENTION LIFELINE.—
(1) PLAN.—Section 520E–3 of the Public Health Service Act
(42 U.S.C. 290bb–36c) is amended—
(A) by redesignating subsection (c) as subsection (e); and
(B) by inserting after subsection (b) the following:
‘‘(c) PLAN.—
‘‘(1) IN GENERAL.—For purposes of maintaining the suicide
prevention hotline under subsection (b)(2), the Secretary shall
develop and implement a plan to ensure the provision of high-
quality service.
‘‘(2) CONTENTS.—The plan required by paragraph (1) shall
include the following:
‘‘(A) Quality assurance provisions, including—
‘‘(i) clearly defined and measurable performance in-
dicators and objectives to improve the responsiveness
and performance of the hotline, including at backup
call centers; and
‘‘(ii) quantifiable timeframes to track the progress of
the hotline in meeting such performance indicators
and objectives.
‘‘(B) Standards that crisis centers and backup centers
must meet—
‘‘(i) to participate in the network under subsection
(b)(1); and
‘‘(ii) to ensure that each telephone call, online chat
message, and other communication received by the
hotline, including at backup call centers, is answered
in a timely manner by a person, consistent with the
guidance established by the American Association of
Suicidology or other guidance determined by the Sec-
retary to be appropriate.
‘‘(C) Guidelines for crisis centers and backup centers to
implement evidence-based practices including with respect
to followup and referral to other health and social services
resources.
‘‘(D) Guidelines to ensure that resources are available
and distributed to individuals using the hotline who are
not personally in a time of crisis but know of someone who
is.
‘‘(E) Guidelines to carry out periodic testing of the hot-
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line, including at crisis centers and backup centers, during
each fiscal year to identify and correct any problems in a
timely manner.
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44
‘‘(F) Guidelines to operate in consultation with the State
department of health, local governments, Indian tribes,
and tribal organizations.
‘‘(3) INITIAL PLAN; UPDATES.—The Secretary shall—
‘‘(A) not later than 6 months after the date of enactment
of the Restoring Hope for Mental Health and Well-Being
Act of 2022, complete development of the initial version of
the plan required by paragraph (1), begin implementation
of such plan, and make such plan publicly available; and
‘‘(B) periodically thereafter, update such plan and make
the updated plan publicly available.’’.
(2) TRANSMISSION OF DATA TO CDC.—Section 520E–3 of the
Public Health Service Act (42 U.S.C. 290bb–36c) is amended by
inserting after subsection (c) of such section, as added by para-
graph (1), the following:
‘‘(d) TRANSMISSION OF DATA TO CDC.—The Secretary shall for-
malize and strengthen agreements between the National Suicide
Prevention Lifeline program and the Centers for Disease Control
and Prevention to transmit any necessary epidemiological data
from the program to the Centers, including local call center data,
to assist the Centers in suicide prevention efforts.’’.
(3) AUTHORIZATION OF APPROPRIATIONS.—Subsection (e) of
section 520E–3 of the Public Health Service Act (42 U.S.C.
290bb–36c) is amended to read as follows:
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) IN GENERAL.—To carry out this section, there are au-
thorized to be appropriated $101,621,000 for each of fiscal
years 2023 through 2027.
‘‘(2) ALLOCATION.—Of the amount authorized to be appro-
priated by paragraph (1) for each of fiscal years 2023 through
2027—
‘‘(A) at least 80 percent shall be made available to crisis
centers; and
‘‘(B) not more than 10 percent may be used for carrying
out the pilot program in section 103(b)(1) of the Restoring
Hope for Mental Health and Well-Being Act of 2022.’’.
(b) PILOT PROGRAM ON INNOVATIVE TECHNOLOGIES.—
(1) IN GENERAL.—The Secretary of Health and Human Serv-
ices, acting through the Assistant Secretary for Mental Health
and Substance Use, shall carry out a pilot program to research,
analyze, and employ various technologies and platforms of
communication (including social media platforms, texting plat-
forms, and email platforms) for suicide prevention in addition
to the telephone and online chat service provided by the Sui-
cide Prevention Lifeline.
(2) REPORT.—Not later than 24 months after the date on
which the pilot program under paragraph (1) commences, the
Secretary of Health and Human Services, acting through the
Assistant Secretary for Mental Health and Substance Use,
shall submit to the Congress a report on the pilot program.
With respect to each platform of communication employed pur-
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suant to the pilot program, the report shall include—
(A) a full description of the program;
(B) the number of individuals served by the program;
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45
(C) the average wait time for each individual to receive
a response;
(D) the cost of the program, including the cost per indi-
vidual served; and
(E) any other information the Secretary determines ap-
propriate.
(c) HHS STUDY AND REPORT.—Not later than 24 months after the
Secretary of Health and Human Services begins implementation of
the plan required by section 520E–3(c) of the Public Health Service
Act, as added by subsection (a)(1)(B), the Secretary shall—
(1) complete a study on—
(A) the implementation of such plan, including the
progress towards meeting the objectives identified pursu-
ant to paragraph (2)(A)(i) of such section 520E–3(c) by the
timeframes identified pursuant to paragraph (2)(A)(ii) of
such section 520E–3(c); and
(B) in consultation with the Director of the Centers for
Disease Control and Prevention, options to expand data
gathering from calls to the Suicide Prevention Lifeline in
order to better track aspects of usage such as repeat calls,
consistent with applicable Federal and State privacy laws;
and
(2) submit a report to the Congress on the results of such
study, including recommendations on whether additional legis-
lation or appropriations are needed.
(d) GAO STUDY AND REPORT.—
(1) IN GENERAL.—Not later than 24 months after the Sec-
retary of Health and Human Services begins implementation of
the plan required by section 520E–3(c) of the Public Health
Service Act, as added by subsection (a)(1)(B), the Comptroller
General of the United States shall—
(A) complete a study on the Suicide Prevention Lifeline;
and
(B) submit a report to the Congress on the results of
such study.
(2) ISSUES TO BE STUDIED.—The study required by paragraph
(1) shall address—
(A) the feasibility of geolocating callers to direct calls to
the nearest crisis center;
(B) operation shortcomings of the Suicide Prevention
Lifeline;
(C) geographic coverage of each crisis call center;
(D) the call answer rate of each crisis call center;
(E) the call wait time of each crisis call center;
(F) the hours of operation of each crisis call center;
(G) funding avenues of each crisis call center;
(H) the implementation of the plan under section 520E–
3(c) of the Public Health Service Act, as added by sub-
section (a)(1)(B), including the progress towards meeting
the objectives identified pursuant to paragraph (2)(A)(i) of
such section 520E–3(c) by the timeframes identified pursu-
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ant to paragraph (2)(A)(ii) of such section 520E–3(c); and
(I) service to individuals requesting a foreign language
speaker, including—
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46
(i) the number of calls or chats the Lifeline receives
from individuals speaking a foreign language;
(ii) the capacity of the Lifeline to handle these calls
or chats; and
(iii) the number of crisis centers with the capacity to
serve foreign language speakers, in house.
(3) RECOMMENDATIONS.—The report required by paragraph
(1) shall include recommendations for improving the Suicide
Prevention Lifeline, including recommendations for legislative
and administrative actions.
(e) DEFINITION.—In this section, the term ‘‘Suicide Prevention
Lifeline’’ means the suicide prevention hotline maintained pursu-
ant to section 520E–3 of the Public Health Service Act (42 U.S.C.
290bb–36c).
11. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE KIM OF
NEW JERSEY OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
At the end of title II, add the following new subtitle:
Subtitle G—Opioid Epidemic Response
SEC. 271. SYNTHETIC OPIOID DANGER AWARENESS.
(a) SYNTHETIC OPIOIDS PUBLIC AWARENESS CAMPAIGN.—Part B of
title III of the Public Health Service Act is amended by inserting
after section 317U (42 U.S.C. 247b–23) the following new section:
‘‘SEC. 317V. SYNTHETIC OPIOIDS PUBLIC AWARENESS CAMPAIGN.
‘‘(a) IN GENERAL.—Not later than one year after the date of the
enactment of this section, the Secretary shall provide for the plan-
ning and implementation of a public education campaign to raise
public awareness of synthetic opioids (including fentanyl and its
analogues). Such campaign shall include the dissemination of infor-
mation that—
‘‘(1) promotes awareness about the potency and dangers of
fentanyl and its analogues and other synthetic opioids;
‘‘(2) explains services provided by the Substance Abuse and
Mental Health Services Administration and the Centers for
Disease Control and Prevention (and any entity providing such
services under a contract entered into with such agencies) with
respect to the misuse of opioids, particularly as such services
relate to the provision of alternative, non-opioid pain manage-
ment treatments; and
‘‘(3) relates generally to opioid use and pain management.
‘‘(b) USE OF MEDIA.—The campaign under subsection (a) may be
implemented through the use of television, radio, internet, in-per-
son public communications, and other commercial marketing
venues and may be targeted to specific age groups.
‘‘(c) CONSIDERATION OF REPORT FINDINGS.—In planning and im-
plementing the public education campaign under subsection (a), the
Secretary shall take into consideration the findings of the report re-
quired under section 7001 of the SUPPORT for Patients and Com-
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munities Act (Public Law 115–271).
‘‘(d) CONSULTATION.—In coordinating the campaign under sub-
section (a), the Secretary shall consult with the Assistant Secretary
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47
for Mental Health and Substance Use to provide ongoing advice on
the effectiveness of information disseminated through the cam-
paign.
‘‘(e) REQUIREMENT OF CAMPAIGN.—The campaign implemented
under subsection (a) shall not be duplicative of any other Federal
efforts relating to eliminating the misuse of opioids.
‘‘(f) EVALUATION.—
‘‘(1) IN GENERAL.—The Secretary shall ensure that the cam-
paign implemented under subsection (a) is subject to an inde-
pendent evaluation, beginning 2 years after the date of the en-
actment of this section, and every 2 years thereafter.
‘‘(2) MEASURES AND BENCHMARKS.—For purposes of an eval-
uation conducted pursuant to paragraph (1), the Secretary
shall—
‘‘(A) establish baseline measures and benchmarks to
quantitatively evaluate the impact of the campaign under
this section; and
‘‘(B) conduct qualitative assessments regarding the effec-
tiveness of strategies employed under this section.
‘‘(g) REPORT.—The Secretary shall, beginning 2 years after the
date of the enactment of this section, and every 2 years thereafter,
submit to Congress a report on the effectiveness of the campaign
implemented under subsection (a) towards meeting the measures
and benchmarks established under subsection (e)(2).
‘‘(h) DISSEMINATION OF INFORMATION THROUGH PROVIDERS.—The
Secretary shall develop and implement a plan for the dissemination
of information related to synthetic opioids, to health care providers
who participate in Federal programs, including programs adminis-
tered by the Department of Health and Human Services, the In-
dian Health Service, the Department of Veterans Affairs, the De-
partment of Defense, and the Health Resources and Services Ad-
ministration, the Medicare program under title XVIII of the Social
Security Act, and the Medicaid program under title XIX of such
Act.’’.
(b) TRAINING GUIDE AND OUTREACH ON SYNTHETIC OPIOID EXPO-
SURE PREVENTION.—
(1) TRAINING GUIDE.—Not later than 18 months after the
date of the enactment of this Act, the Secretary of Health and
Human Services shall design, publish, and make publicly avail-
able on the internet website of the Department of Health and
Human Services, a training guide and webinar for first re-
sponders and other individuals who also may be at high risk
of exposure to synthetic opioids that details measures to pre-
vent that exposure.
(2) OUTREACH.—Not later than 18 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall also conduct outreach about the availability of
the training guide and webinar published under paragraph (1)
to—
(A) police and fire managements;
(B) sheriff deputies in city and county jails;
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(C) ambulance transport and hospital emergency room
personnel;
(D) clinicians; and
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48
(E) other high-risk occupations, as identified by the As-
sistant Secretary for Mental Health and Substance Use.
12. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE MCKIN-
LEY OF WEST VIRGINIA OR HIS DESIGNEE, DEBATABLE FOR 10
MINUTES
After section 263, insert the following new section:
SEC. 264. BLOCK, REPORT, AND SUSPEND SUSPICIOUS SHIPMENTS.
(a) CLARIFICATION OF PROCESS FOR REGISTRANTS TO EXERCISE
DUE DILIGENCE UPON DISCOVERING A SUSPICIOUS ORDER.—Para-
graph (3) of section 312(a) of the Controlled Substances Act (21
U.S.C. 832(a)) is amended to read as follows:
‘‘(3) upon discovering a suspicious order or series of orders,
and in a manner consistent with the other requirements of this
section—
‘‘(A) exercise due diligence as appropriate;
‘‘(B) establish and maintain (for not less than a period
to be determined by the Administrator of the Drug En-
forcement Administration) a record of the due diligence
that was performed;
‘‘(C) decline to fill the order or series of orders if the due
diligence fails to dispel all of the indicators that give rise
to the suspicion that, if the order or series of orders is
filled, the drugs that are the subject of the order or series
of orders are likely to be diverted; and
‘‘(D) notify the Administrator of the Drug Enforcement
Administration and the Special Agent in Charge of the Di-
vision Office of the Drug Enforcement Administration for
the area in which the registrant is located or conducts
business of—
‘‘(i) each suspicious order or series of orders discov-
ered by the registrant; and
‘‘(ii) the indicators giving rise to the suspicion that,
if the order or series of orders is filled, the drugs that
are the subject of the order or series of orders are like-
ly to be diverted.’’.
(b) RESOLUTION OF SUSPICIOUS INDICATORS.—Section 312 of the
Controlled Substances Act (21 U.S.C. 832) is amended—
(1) by redesignating subsection (b) and (c) as subsections (c)
and (d), respectively; and
(2) by inserting after subsection (a) the following:
‘‘(b) RESOLUTION OF SUSPICIOUS INDICATORS.—If a registrant re-
solves all of the indicators giving rise to suspicion about an order
or series of orders under subsection (a)(3)—
‘‘(1) notwithstanding subsection (a)(3)(C), the registrant may
choose to fill the order or series of orders; and
‘‘(2) notwithstanding subsection (a)(3)(D), the registrant may
choose not to make the notification otherwise required by such
subsection.’’.
(c) REGULATIONS.—Not later than 1 year after the date of enact-
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ment of this Act, for purposes of subsections (a)(3) and (b) of section
312 of the Controlled Substances Act, as amended or inserted by
subsection (a), the Attorney General of the United States shall pro-
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49
mulgate a final regulation specifying the indicators that give rise
to a suspicion that, if an order or series of orders is filled, the drugs
that are the subject of the order or series of orders are likely to be
diverted.
(d) APPLICABILITY.—Subsections (a)(3) and (b) of section 312 of
the Controlled Substances Act, as amended or inserted by sub-
section (a), shall apply beginning on the day that is 1 year after
the date of enactment of this Act. Until such day, section 312(a)(3)
of the Controlled Substances Act shall apply as such section
312(a)(3) was in effect on the day before the date of enactment of
this Act.
13. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE MOORE
OF WISCONSIN OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES
Page 20, line 4, strike ‘‘and’’.
Page 20, line 9, strike the period at the end and insert ‘‘; and’’.
Page 20, after line 9, add the following:
‘‘(4) consult with appropriate State, local, and Tribal public
health officials, including officials that administer programs
that serve low-income pregnant and postpartum individuals.’’.
14. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE NAPOLI-
TANO OF CALIFORNIA OR HER DESIGNEE, DEBATABLE FOR 10 MIN-
UTES
After section 402, insert the following new section:
SEC. 403. SCHOOL-BASED MENTAL HEALTH; CHILDREN AND ADOLES-
CENTS.
(a) TECHNICAL AMENDMENTS.—The second part G (relating to
services provided through religious organizations) of title V of the
Public Health Service Act (42 U.S.C. 290kk et seq.) is amended—
(1) by redesignating such part as part J; and
(2) by redesignating sections 581 through 584 as sections 596
through 596C, respectively.
(b) SCHOOL-BASED MENTAL HEALTH AND CHILDREN.—Section 581
of the Public Health Service Act (42 U.S.C. 290hh) (relating to chil-
dren and violence) is amended to read as follows:
‘‘SEC. 581. SCHOOL-BASED MENTAL HEALTH; CHILDREN AND ADOLES-
CENTS.
‘‘(a) IN GENERAL.—The Secretary, in consultation with the Sec-
retary of Education, shall, through grants, contracts, or cooperative
agreements awarded to eligible entities described in subsection (c),
provide comprehensive school-based mental health services and
supports to assist children in local communities and schools (in-
cluding schools funded by the Bureau of Indian Education) dealing
with traumatic experiences, grief, bereavement, risk of suicide, and
violence. Such services and supports shall be—
‘‘(1) developmentally, linguistically, and culturally appro-
priate;
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‘‘(2) trauma-informed; and
‘‘(3) incorporate positive behavioral interventions and sup-
ports.
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50
‘‘(b) ACTIVITIES.—Grants, contracts, or cooperative agreements
awarded under subsection (a), shall, as appropriate, be used for—
‘‘(1) implementation of school and community-based mental
health programs that—
‘‘(A) build awareness of individual trauma and the inter-
generational, continuum of impacts of trauma on popu-
lations;
‘‘(B) train appropriate staff to identify, and screen for,
signs of trauma exposure, mental health disorders, or risk
of suicide; and
‘‘(C) incorporate positive behavioral interventions, family
engagement, student treatment, and multigenerational
supports to foster the health and development of children,
prevent mental health disorders, and ameliorate the im-
pact of trauma;
‘‘(2) technical assistance to local communities with respect to
the development of programs described in paragraph (1);
‘‘(3) facilitating community partnerships among families, stu-
dents, law enforcement agencies, education agencies, mental
health and substance use disorder service systems, family-
based mental health service systems, child welfare agencies,
health care providers (including primary care physicians, men-
tal health professionals, and other professionals who specialize
in children’s mental health such as child and adolescent psy-
chiatrists), institutions of higher education, faith-based pro-
grams, trauma networks, and other community-based systems
to address child and adolescent trauma, mental health issues,
and violence; and
‘‘(4) establishing mechanisms for children and adolescents to
report incidents of violence or plans by other children, adoles-
cents, or adults to commit violence.
‘‘(c) REQUIREMENTS.—
‘‘(1) IN GENERAL.—To be eligible for a grant, contract, or co-
operative agreement under subsection (a), an entity shall be a
partnership that includes—
‘‘(A) a State educational agency, as defined in section
8101 of the Elementary and Secondary Education Act of
1965, in coordination with one or more local educational
agencies, as defined in section 8101 of the Elementary and
Secondary Education Act of 1965, or a consortium of any
entities described in subparagraph (B), (C), (D), or (E) of
section 8101(30) of such Act; and
‘‘(B) at least 1 community-based mental health provider,
including a public or private mental health entity, health
care entity, family-based mental health entity, trauma net-
work, or other community-based entity, as determined by
the Secretary (and which may include additional entities
such as a human services agency, law enforcement or juve-
nile justice entity, child welfare agency, agency, an institu-
tion of higher education, or another entity, as determined
by the Secretary).
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‘‘(2) COMPLIANCE WITH HIPAA.—Any patient records devel-
oped by covered entities through activities under the grant
shall meet the regulations promulgated under section 264(c) of
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51
the Health Insurance Portability and Accountability Act of
1996.
‘‘(3) COMPLIANCE WITH FERPA.—Section 444 of the General
Education Provisions Act (commonly known as the ‘Family
Educational Rights and Privacy Act of 1974’) shall apply to any
entity that is a member of the partnership in the same manner
that such section applies to an educational agency or institu-
tion (as that term is defined in such section).
‘‘(d) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure
that grants, contracts, or cooperative agreements under subsection
(a) will be distributed equitably among the regions of the country
and among urban and rural areas.
‘‘(e) DURATION OF AWARDS.—With respect to a grant, contract, or
cooperative agreement under subsection (a), the period during
which payments under such an award will be made to the recipient
shall be 5 years, with options for renewal.
‘‘(f) EVALUATION AND MEASURES OF OUTCOMES.—
‘‘(1) DEVELOPMENT OF PROCESS.—The Assistant Secretary
shall develop a fiscally appropriate process for evaluating ac-
tivities carried out under this section. Such process shall in-
clude—
‘‘(A) the development of guidelines for the submission of
program data by grant, contract, or cooperative agreement
recipients;
‘‘(B) the development of measures of outcomes (in accord-
ance with paragraph (2)) to be applied by such recipients
in evaluating programs carried out under this section; and
‘‘(C) the submission of annual reports by such recipients
concerning the effectiveness of programs carried out under
this section.
‘‘(2) MEASURES OF OUTCOMES.—The Assistant Secretary shall
develop measures of outcomes to be applied by recipients of as-
sistance under this section to evaluate the effectiveness of pro-
grams carried out under this section, including outcomes re-
lated to the student, family, and local educational systems sup-
ported by this Act.
‘‘(3) SUBMISSION OF ANNUAL DATA.—An eligible entity de-
scribed in subsection (c) that receives a grant, contract, or co-
operative agreement under this section shall annually submit
to the Assistant Secretary a report that includes data to evalu-
ate the success of the program carried out by the entity based
on whether such program is achieving the purposes of the pro-
gram. Such reports shall utilize the measures of outcomes
under paragraph (2) in a reasonable manner to demonstrate
the progress of the program in achieving such purposes.
‘‘(4) EVALUATION BY ASSISTANT SECRETARY.—Based on the
data submitted under paragraph (3), the Assistant Secretary
shall annually submit to Congress a report concerning the re-
sults and effectiveness of the programs carried out with assist-
ance received under this section.
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‘‘(5) LIMITATION.—An eligible entity shall use not more than
20 percent of amounts received under a grant under this sec-
tion to carry out evaluation activities under this subsection.
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52
‘‘(g) INFORMATION AND EDUCATION.—The Secretary shall dissemi-
nate best practices based on the findings of the knowledge develop-
ment and application under this section.
‘‘(h) AMOUNT OF GRANTS AND AUTHORIZATION OF APPROPRIA-
TIONS.—
‘‘(1) AMOUNT OF GRANTS.—A grant under this section shall be
in an amount that is not more than $2,000,000 for each of the
first 5 fiscal years following the date of enactment of the Re-
storing Hope for Mental Health and Well-Being Act of 2022.
The Secretary shall determine the amount of each such grant
based on the population of children up to age 21 of the area
to be served under the grant.
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—There is author-
ized to be appropriated to carry out this section, $130,000,000
for each of fiscal years 2023 through 2027.’’.
(c) CONFORMING AMENDMENT.—Part G of title V of the Public
Health Service Act (42 U.S.C. 290hh et seq.), as amended by sub-
section (b), is further amended by striking the part designation and
heading and inserting the following:
‘‘PART G—SCHOOL-BASED MENTAL HEALTH’’.
15. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE PRESSLEY
OF MASSACHUSETTS OR HER DESIGNEE, DEBATABLE FOR 10 MIN-
UTES
After section 402, insert the following new section:
SEC. 403. CO-OCCURRING CHRONIC CONDITIONS AND MENTAL
HEALTH IN YOUTH STUDY.
Not later than 12 months after the date of enactment of this Act,
the Secretary of Health and Human Services shall—
(1) complete a study on the rates of suicidal behaviors among
children and adolescents with chronic illnesses, including sub-
stance use disorders, autoimmune disorders, and heritable
blood disorders; and
(2) submit a report to the Congress on the results of such
study, including recommendations for early intervention serv-
ices for such children and adolescents at risk of suicide, the
dissemination of best practices to support the emotional and
mental health needs of youth, and strategies to lower the rates
of suicidal behaviors in children and adolescents described in
paragraph (1) to reduce any demographic disparities in such
rates.
16. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE
RESCHENTHALER OF PENNSYLVANIA OR HIS DESIGNEE, DEBAT-
ABLE FOR 10 MINUTES
At the end of subtitle C of title I, add the following new section:
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SEC. 124. STUDY ON THE COSTS OF SERIOUS MENTAL ILLNESS.
(a) IN GENERAL.—The Secretary of Health and Human Services,
in consultation with the Assistant Secretary for Mental Health and
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53
Substance Use, the Assistant Secretary for Planning and Evalua-
tion, the Attorney General of the United States, the Secretary of
Labor, and the Secretary of Housing and Urban Development, shall
conduct a study on the direct and indirect costs of serious mental
illness with respect to—
(1) nongovernmental entities; and
(2) the Federal Government and State, local, and Tribal gov-
ernments.
(b) CONTENT.—The study under subsection (a) shall consider
each of the following:
(1) The costs to the health care system for health services,
including with respect to—
(A) office-based physician visits;
(B) residential and inpatient treatment programs;
(C) outpatient treatment programs;
(D) emergency room visits;
(E) crisis stabilization programs;
(F) home health care;
(G) skilled nursing and long-term care facilities;
(H) prescription drugs and digital therapeutics; and
(I) any other relevant health services.
(2) The costs of homelessness, including with respect to—
(A) homeless shelters;
(B) street outreach activities;
(C) crisis response center visits; and
(D) other supportive services.
(3) The costs of structured residential facilities and other
supportive housing for residential and custodial care services.
(4) The costs of law enforcement encounters and encounters
with the criminal justice system, including with respect to—
(A) encounters that do and do not result in an arrest;
(B) criminal and judicial proceedings;
(C) services provided by law enforcement and judicial
staff (including public defenders, prosecutors, and private
attorneys); and
(D) incarceration.
(5) The costs of serious mental illness on employment.
(6) With respect to family members and caregivers, the costs
of caring for an individual with a serious mental illness.
(7) Any other relevant costs for programs and services ad-
ministered by the Federal Government or State, Tribal, or local
governments.
(c) DATA DISAGGREGATION.—In conducting the study under sub-
section (a), the Secretary of Health and Human Services shall (to
the extent feasible)—
(1) disaggregate data by—
(A) costs to nongovernmental entities, the Federal Gov-
ernment, and State, local, and Tribal governments;
(B) types of serious mental illnesses and medical chronic
diseases common in patients with a serious mental illness;
and
(C) demographic characteristics, including race, eth-
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nicity, sex, age (including pediatric subgroups), and other
characteristics determined by the Secretary; and
(2) include an estimate of—
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54
(A) the total number of individuals with a serious men-
tal illness in the United States, including in traditional
and nontraditional housing; and
(B) the percentage of such individuals in—
(i) homeless shelters;
(ii) penal facilities, including Federal prisons, State
prisons, and county and municipal jails; and
(iii) nursing facilities.
(d) REPORT.—Not later than 2 years after the date of the enact-
ment of this Act, the Secretary of Health and Human Services
shall—
(1) submit to the Congress a report containing the results of
the study conducted under this section; and
(2) make such report publicly available.
17. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE TRONE OF
MARYLAND OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES
At the end of title II, add the following new subtitle:
Subtitle I—Opioid Epidemic Response
SEC. 271. GRANT PROGRAM FOR STATE AND TRIBAL RESPONSE TO
OPIOID AND STIMULANT USE AND MISUSE.
Section 1003 of the 21st Century Cures Act (42 U.S.C. 290ee–3
note) is amended to read as follows:
‘‘SEC. 1003. GRANT PROGRAM FOR STATE AND TRIBAL RESPONSE TO
OPIOID AND STIMULANT USE AND MISUSE.
‘‘(a) IN GENERAL.—The Secretary of Health and Human Services
(referred to in this section as the ‘Secretary’) shall carry out the
grant program described in subsection (b) for purposes of address-
ing opioid and stimulant use and misuse, within States, Indian
Tribes, and populations served by Tribal organizations and Urban
Indian organizations.
‘‘(b) GRANTS PROGRAM.—
‘‘(1) IN GENERAL.—Subject to the availability of appropria-
tions, the Secretary shall award grants to States, Indian
Tribes, Tribal organizations, and Urban Indian organizations
for the purpose of addressing opioid and stimulant use and
misuse, within such States, such Indian Tribes, and popu-
lations served by such Tribal organizations and Urban Indian
organizations, in accordance with paragraph (2).
‘‘(2) MINIMUM ALLOCATIONS; PREFERENCE.—In determining
grant amounts for each recipient of a grant under paragraph
(1), the Secretary shall—
‘‘(A) ensure that each State receives not less than
$4,000,000; and
‘‘(B) give preference to States, Indian Tribes, Tribal orga-
nizations, and Urban Indian organizations whose popu-
lations have an incidence or prevalence of opioid use dis-
orders or stimulant use or misuse that is substantially
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higher relative to the populations of other States, other In-
dian Tribes, Tribal organizations, or Urban Indian organi-
zations, as applicable.
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55
‘‘(3) FORMULA METHODOLOGY.—
‘‘(A) IN GENERAL.—Before publishing a funding oppor-
tunity announcement with respect to grants under this
section, the Secretary shall—
‘‘(i) develop a formula methodology to be followed in
allocating grant funds awarded under this section
among grantees, which includes performance assess-
ments for continuation awards; and
‘‘(ii) not later than 30 days after developing the for-
mula methodology under clause (i), submit the formula
methodology to—
‘‘(I) the Committee on Energy and Commerce
and the Committee on Appropriations of the
House of Representatives; and
‘‘(II) the Committee on Health, Education,
Labor, and Pensions and the Committee on Appro-
priations of the Senate.
‘‘(B) REPORT.—Not later than two years after the date of
the enactment of the Restoring Hope for Mental Health
and Well-Being Act of 2022, the Comptroller General of
the United States shall submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the House of
Representatives a report that—
‘‘(i) assesses how grant funding is allocated to States
under this section and how such allocations have
changed over time;
‘‘(ii) assesses how any changes in funding under this
section have affected the efforts of States to address
opioid or stimulant use or misuse; and
‘‘(iii) assesses the use of funding provided through
the grant program under this section and other simi-
lar grant programs administered by the Substance
Abuse and Mental Health Services Administration.
‘‘(4) USE OF FUNDS.—Grants awarded under this subsection
shall be used for carrying out activities that supplement activi-
ties pertaining to opioid and stimulant use and misuse, under-
taken by the State agency responsible for administering the
substance abuse prevention and treatment block grant under
subpart II of part B of title XIX of the Public Health Service
Act (42 U.S.C. 300x–21 et seq.), which may include public
health-related activities such as the following:
‘‘(A) Implementing prevention activities, and evaluating
such activities to identify effective strategies to prevent
substance use disorders.
‘‘(B) Establishing or improving prescription drug moni-
toring programs.
‘‘(C) Training for health care practitioners, such as best
practices for prescribing opioids, pain management, recog-
nizing potential cases of substance use disorders, referral
of patients to treatment programs, preventing diversion of
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controlled substances, and overdose prevention.
‘‘(D) Supporting access to health care services, includ-
ing—
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56
‘‘(i) services provided by federally certified opioid
treatment programs;
‘‘(ii) outpatient and residential substance use dis-
order treatment services that utilize medication-as-
sisted treatment, as appropriate; or
‘‘(iii) other appropriate health care providers to treat
substance use disorders.
‘‘(E) Recovery support services, including—
‘‘(i) community-based services that include peer sup-
ports;
‘‘(ii) mutual aid recovery programs that support
medication-assisted treatment; or
‘‘(iii) services to address housing needs and family
issues.
‘‘(F) Other public health-related activities, as the State,
Indian Tribe, Tribal organization, or Urban Indian organi-
zation determines appropriate, related to addressing sub-
stance use disorders within the State, Indian Tribe, Tribal
organization, or Urban Indian organization, including di-
recting resources in accordance with local needs related to
substance use disorders.
‘‘(c) ACCOUNTABILITY AND OVERSIGHT.—A State receiving a grant
under subsection (b) shall include in reporting related to substance
use disorders submitted to the Secretary pursuant to section 1942
of the Public Health Service Act (42 U.S.C. 300x–52), a description
of—
‘‘(1) the purposes for which the grant funds received by the
State under such subsection for the preceding fiscal year were
expended and a description of the activities of the State under
the grant;
‘‘(2) the ultimate recipients of amounts provided to the State;
and
‘‘(3) the number of individuals served through the grant.
‘‘(d) LIMITATIONS.—Any funds made available pursuant to sub-
section (i)—
‘‘(1) shall not be used for any purpose other than the grant
program under subsection (b); and
‘‘(2) shall be subject to the same requirements as substance
use disorders prevention and treatment programs under titles
V and XIX of the Public Health Service Act (42 U.S.C. 290aa
et seq., 300w et seq.).
‘‘(e) INDIAN TRIBES, TRIBAL ORGANIZATIONS, AND URBAN INDIAN
ORGANIZATIONS.—The Secretary, in consultation with Indian
Tribes, Tribal organizations, and Urban Indian organizations, shall
identify and establish appropriate mechanisms for Indian Tribes,
Tribal organizations, and Urban Indian organizations to dem-
onstrate or report the information as required under subsections
(b), (c), and (d).
‘‘(f) REPORT TO CONGRESS.—Not later than September 30, 2024,
and biennially thereafter, the Secretary shall submit to the Com-
mittee on Health, Education, Labor, and Pensions of the Senate
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and the Committee on Energy and Commerce of the House of Rep-
resentatives, and the Committees on Appropriations of the House
of Representatives and the Senate, a report that includes a sum-
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57
mary of the information provided to the Secretary in reports made
pursuant to subsections (c) and (e), including—
‘‘(1) the purposes for which grant funds are awarded under
this section;
‘‘(2) the activities of the grant recipients; and
‘‘(3) for each State, Indian Tribe, Tribal organization, and
Urban Indian organization that receives a grant under this
section, the funding level provided to such recipient.
‘‘(g) TECHNICAL ASSISTANCE.—The Secretary, including through
the Tribal Training and Technical Assistance Center of the Sub-
stance Abuse and Mental Health Services Administration, shall
provide States, Indian Tribes, Tribal organizations, and Urban In-
dian organizations, as applicable, with technical assistance con-
cerning grant application and submission procedures under this
section, award management activities, and enhancing outreach and
direct support to rural and underserved communities and providers
in addressing substance use disorders.
‘‘(h) DEFINITIONS.—In this section:
‘‘(1) INDIAN TRIBE.—The term ‘Indian Tribe’ has the meaning
given the term ‘Indian tribe’ in section 4 of the Indian Self-De-
termination and Education Assistance Act (25 U.S.C. 5304).
‘‘(2) TRIBAL ORGANIZATION.—The term ‘Tribal organization’
has the meaning given the term ‘tribal organization’ in such
section 4.
‘‘(3) STATE.—The term ‘State’ has the meaning given such
term in section 1954(b) of the Public Health Service Act (42
U.S.C. 300x–64(b)).
‘‘(4) URBAN INDIAN ORGANIZATION.—The term ‘Urban Indian
organization’ has the meaning given such term in section 4 of
the Indian Health Care Improvement Act.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(1) IN GENERAL.—For purposes of carrying out the grant
program under subsection (b), there is authorized to be appro-
priated $1,750,000,000 for each of fiscal years 2023 through
2027, to remain available until expended.
‘‘(2) FEDERAL ADMINISTRATIVE EXPENSES.—Of the amounts
made available for each fiscal year to award grants under sub-
section (b), the Secretary shall not use more than 20 percent
for Federal administrative expenses, training, technical assist-
ance, and evaluation.
‘‘(3) SET ASIDE.—Of the amounts made available for each fis-
cal year to award grants under subsection (b) for a fiscal year,
the Secretary shall—
‘‘(A) award 5 percent to Indian Tribes, Tribal organiza-
tions, and Urban Indian organizations; and
‘‘(B) of the amount remaining after application of sub-
paragraph (A), set aside up to 15 percent for awards to
States with the highest age-adjusted rate of drug overdose
death based on the ordinal ranking of States according to
the Director of the Centers for Disease Control and Pre-
vention.’’.
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Æ
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