257 
shall be paid as a Federally qualified 
health center service or rural health clinic 
service (as applicable) under the prospec-
tive payment system established under sec-
tion 1834(o) or the methodology for all-in-
clusive rates established under section 
1833(a)(3), respectively. 
‘‘(ii) TREATMENT
OF
COSTS.—Costs 
associated with the furnishing of telehealth 
services by a Federally qualified health 
center or rural health clinic on or after 
January 1, 2025, and before January 1, 
2027, shall be considered allowable costs 
for purposes of the prospective payment 
system established under section 1834(o) 
and the methodology for all-inclusive rates 
established under section 1833(a)(3), as 
applicable. 
‘‘(iii) REQUIRING
MODIFIERS.—Not 
later than July 1, 2025, the Secretary 
shall establish requirements to include 1 or 
more codes or modifiers, as determined ap-
propriate by the Secretary, in the case of 
claims for telehealth services furnished to 
an eligible telehealth individual by a Feder-
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258 
ally qualified health center or rural health 
clinic.’’. 
(d) DELAYING
THE
IN-PERSON
REQUIREMENTS 
UNDER MEDICARE
FOR MENTAL HEALTH SERVICES 
FURNISHED
THROUGH
TELEHEALTH
AND
TELE-
COMMUNICATIONS TECHNOLOGY.— 
(1) DELAY
IN
REQUIREMENTS
FOR
MENTAL 
HEALTH
SERVICES
FURNISHED
THROUGH
TELE-
HEALTH.—Section 1834(m)(7)(B)(i) of the Social 
Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is 
amended, in the matter preceding subclause (I), by 
striking ‘‘on or after April 1, 2025’’ and inserting 
‘‘on or after January 1, 2027’’. 
(2) MENTAL
HEALTH
VISITS
FURNISHED
BY 
RURAL HEALTH CLINICS.—Section 1834(y)(2) of the 
Social Security Act (42 U.S.C. 1395m(y)(2)) is 
amended by striking ‘‘April 1, 2025’’ and inserting 
‘‘January 1, 2027’’. 
(3) MENTAL
HEALTH
VISITS
FURNISHED
BY 
FEDERALLY QUALIFIED HEALTH CENTERS.—Section 
1834(o)(4)(B) of the Social Security Act (42 U.S.C. 
1395m(o)(4)(B)) is amended by striking ‘‘April 1, 
2025’’ and inserting ‘‘January 1, 2027.’’. 
(e) ALLOWING FOR THE FURNISHING OF AUDIO- 
ONLY TELEHEALTH SERVICES.—Section 1834(m)(9) of 
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259 
the Social Security Act (42 U.S.C. 1395m(m)(9)) is 
amended by striking ‘‘ending on March 31, 2025’’ and in-
serting ‘‘ending on December 31, 2026’’. 
(f) EXTENDING USE OF TELEHEALTH TO CONDUCT 
FACE-TO-FACE ENCOUNTER PRIOR TO RECERTIFICATION 
OF
ELIGIBILITY
FOR
HOSPICE
CARE.—Section 
1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 
1395f(a)(7)(D)(i)(II)) is amended— 
(1) by striking ‘‘ending on March 31, 2025’’ 
and inserting ‘‘ending on December 31, 2026’’; and 
(2) by inserting ‘‘, except that this subclause 
shall not apply in the case of such an encounter with 
an individual occurring on or after January 1, 2025, 
if such individual is located in an area that is sub-
ject to a moratorium on the enrollment of hospice 
programs under this title pursuant to section 
1866(j)(7), if such individual is receiving hospice 
care from a provider that is subject to enhanced 
oversight under this title pursuant to section 
1866(j)(3), or if such encounter is performed by a 
hospice physician or nurse practitioner who is not 
enrolled under section 1866(j) and is not an opt-out 
physician or practitioner (as defined in section 
1802(b)(6)(D))’’ before the semicolon. 
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260 
(g) REQUIRING MODIFIERS FOR TELEHEALTH SERV-
ICES IN CERTAIN INSTANCES.—Section 1834(m) of the 
Social Security Act (42 U.S.C. 1395m(m)) is amended by 
adding at the end the following new paragraph: 
‘‘(10) REQUIRED USE OF MODIFIERS IN CER-
TAIN INSTANCES.—Not later than January 1, 2026, 
the Secretary shall establish requirements to include 
1 or more codes or modifiers, as determined appro-
priate by the Secretary, in the case of— 
‘‘(A) claims for telehealth services under 
this subsection that are furnished through a 
telehealth virtual platform— 
‘‘(i) by a physician or practitioner 
that contracts with an entity that owns 
such virtual platform; or 
‘‘(ii) for which a physician or practi-
tioner has a payment arrangement with an 
entity for use of such virtual platform; and 
‘‘(B) claims for telehealth services under 
this subsection that are furnished incident to a 
physician’s or practitioner’s professional serv-
ice.’’. 
(h) PROGRAM INSTRUCTION AUTHORITY.—The Sec-
retary of Health and Human Services may implement the 
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261 
amendments made by this section through program in-
struction or otherwise. 
SEC. 210. REQUIRING MODIFIER FOR USE OF TELEHEALTH 
TO 
CONDUCT 
FACE-TO-FACE 
ENCOUNTER 
PRIOR TO RECERTIFICATION OF ELIGIBILITY 
FOR HOSPICE CARE. 
Section 1814(a)(7)(D)(i)(II) of the Social Security 
Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)), as amended by sec-
tion 209(f) of the Health Improvements, Extenders, and 
Reauthorizations Act, is further amended by inserting ‘‘, 
but only if, in the case of such an encounter occurring 
on or after January 1, 2026, any hospice claim includes 
1 or more modifiers or codes (as specified by the Sec-
retary) to indicate that such encounter was conducted via 
telehealth’’ after ‘‘as determined appropriate by the Sec-
retary’’. 
SEC. 211. EXTENDING ACUTE HOSPITAL CARE AT HOME 
WAIVER FLEXIBILITIES. 
Section 1866G of the Social Security Act (42 U.S.C. 
1395cc–7) is amended— 
(1) in the section heading, by inserting ‘‘THE 
THOMAS
R. CARPER, TIM
SCOTT, BRAD
R. 
WENSTRUP, D.P.M., AND EARL BLUMENAUER’’ 
after ‘‘EXTENSION OF’’; 
(2) in subsection (a)— 
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262 
(A) in paragraph (1)— 
(i) by striking ‘‘March 31, 2025’’ and 
inserting ‘‘December 31, 2029’’; and 
(ii) by striking ‘‘in the Acute Hospital 
Care at Home initiative of the Secretary’’ 
and inserting ‘‘in the Thomas R. Carper, 
Tim Scott, Brad R. Wenstrup, D.P.M., 
and Earl Blumenauer Acute Hospital Care 
at Home initiative of the Secretary (in this 
section referred to as the ‘Acute Hospital 
Care at Home initiative’)’’; 
(B) in paragraph (2), by striking ‘‘of the 
Secretary’’; and 
(C) in paragraph (3)(E), by adding at the 
end the following new flush sentence: 
‘‘The Secretary may require that such data and 
information be submitted through a hospital’s 
cost report, through such survey instruments as 
the Secretary may develop, through medical 
record information, or through such other 
means as the Secretary determines appro-
priate.’’; 
(3) in subsection (b)— 
(A) in the subsection heading, by striking 
‘‘STUDY’’ and inserting ‘‘INITIAL STUDY’’; 
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263 
(B) in paragraph (1)(A), by striking ‘‘of 
the Secretary’’; and 
(C) in paragraph (3), by inserting ‘‘or sub-
section (c)’’ before the period at the end; 
(4) by redesignating subsections (c) and (d) as 
subsections (d) and (e), respectively; and 
(5) by inserting after subsection (b) the fol-
lowing new subsection: 
‘‘(c) SUBSEQUENT STUDY AND REPORT.— 
‘‘(1) IN GENERAL.—Not later than September 
30, 2028, the Secretary shall conduct a study to— 
‘‘(A) analyze, to the extent practicable, the 
criteria established by hospitals under the Acute 
Hospital Care at Home initiative to determine 
which individuals may be furnished services 
under such initiative; and 
‘‘(B) analyze and compare (both within 
and between hospitals participating in the ini-
tiative, and relative to comparable hospitals 
that do not participate in the initiative, for rel-
evant parameters such as diagnosis-related 
groups)— 
‘‘(i) quality of care furnished to indi-
viduals with similar conditions and charac-
teristics in the inpatient setting and 
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264 
through the Acute Hospital Care at Home 
initiative, including health outcomes, hos-
pital readmission rates (including readmis-
sions both within and beyond 30 days post- 
discharge), hospital mortality rates, length 
of stay, infection rates, composition of care 
team (including the types of labor used, 
such as contracted labor), the ratio of 
nursing staff, transfers from the hospital 
to the home, transfers from the home to 
the hospital (including the timing, fre-
quency, and causes of such transfers), 
transfers and discharges to post-acute care 
settings (including the timing, frequency, 
and causes of such transfers and dis-
charges), and patient and caregiver experi-
ence of care; 
‘‘(ii) clinical conditions treated and di-
agnosis-related groups of discharges from 
inpatient settings relative to discharges 
from the Acute Hospital Care at Home ini-
tiative; 
‘‘(iii) costs incurred by the hospital 
for furnishing care in inpatient settings 
relative to costs incurred by the hospital 
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265 
for furnishing care through the Acute Hos-
pital Care at Home initiative, including 
costs relating to staffing, equipment, food, 
prescriptions, and other services, as deter-
mined by the Secretary; 
‘‘(iv) the quantity, mix, and intensity 
of services (such as in-person visits and 
virtual contacts with patients and the in-
tensity of such services) furnished in inpa-
tient settings relative to the Acute Hospital 
Care at Home initiative, and, to the extent 
practicable, the nature and extent of family 
or caregiver involvement; 
‘‘(v) socioeconomic information on in-
dividuals treated in comparable inpatient 
settings relative to the initiative, including 
racial and ethnic data, income, housing, 
geographic proximity to the brick-and-mor-
tar facility and whether such individuals 
are dually eligible for benefits under this 
title and title XIX; and 
‘‘(vi) the quality of care, outcomes, 
costs, quantity and intensity of services, 
and other relevant metrics between individ-
uals who entered into the Acute Hospital 
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266 
Care at Home initiative directly from an 
emergency department compared with indi-
viduals who entered into the Acute Hos-
pital Care at Home initiative directly from 
an existing inpatient stay in a hospital. 
‘‘(2) SELECTION
BIAS.—In conducting the 
study under paragraph (1), the Secretary shall, to 
the extent practicable, analyze and compare individ-
uals who participate and do not participate in the 
initiative controlling for selection bias or other fac-
tors that may impact the reliability of data. 
‘‘(3) REPORT.—Not later than September 30, 
2028, the Secretary of Health and Human Services 
shall post on a website of the Centers for Medicare 
& Medicaid Services a report on the study conducted 
under paragraph (1). 
‘‘(4) FUNDING.—In addition to amounts other-
wise available, there is appropriated to the Centers 
for Medicare & Medicaid Services Program Manage-
ment Account for fiscal year 2025, out of any 
amounts in the Treasury not otherwise appropriated, 
$6,000,000, respectively, to remain available until 
expended, for purposes of carrying out this section.’’. 
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267 
SEC. 212. ENHANCING CERTAIN PROGRAM INTEGRITY RE-
QUIREMENTS FOR DME UNDER MEDICARE. 
(a) DURABLE MEDICAL EQUIPMENT.— 
(1) IN GENERAL.—Section 1834(a) of the So-
cial Security Act (42 U.S.C. 1395m(a)) is amended 
by adding at the end the following new paragraph: 
‘‘(23) MASTER LIST INCLUSION AND CLAIM RE-
VIEW FOR CERTAIN ITEMS.— 
‘‘(A) MASTER
LIST
INCLUSION.—Begin-
ning January 1, 2028, for purposes of the Mas-
ter List described in section 414.234(b) of title 
42, Code of Federal Regulations (or any suc-
cessor regulation), an item for which payment 
may be made under this subsection shall be 
treated as having aberrant billing patterns (as 
such term is used for purposes of such section) 
if the Secretary determines that, without ex-
planatory contributing factors (such as fur-
nishing emergent care services), a substantial 
number of claims for such items under this sub-
section are for such items ordered by a physi-
cian or practitioner who has not previously 
(during a period of not less than 24 months, as 
established by the Secretary) furnished to the 
individual involved any item or service for which 
payment may be made under this title. 
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‘‘(B) CLAIM
REVIEW.—With respect to 
items furnished on or after January 1, 2028, 
that are included on the Master List pursuant 
to subparagraph (A), if such an item is not sub-
ject to a determination of coverage in advance 
pursuant to paragraph (15)(C), the Secretary 
may conduct prepayment review of claims for 
payment for such item.’’. 
(2) CONFORMING
AMENDMENT
FOR
PROS-
THETIC DEVICES, ORTHOTICS, AND PROSTHETICS.— 
Section 1834(h)(3) of the Social Security Act (42 
U.S.C. 1395m(h)(3)) is amended by inserting ‘‘, and 
paragraph (23) of subsection (a) shall apply to pros-
thetic devices, orthotics, and prosthetics in the same 
manner as such provision applies to items for which 
payment may be made under such subsection’’ be-
fore the period at the end. 
(b) REPORT ON IDENTIFYING CLINICAL DIAGNOSTIC 
LABORATORY TESTS AT HIGH RISK FOR FRAUD AND EF-
FECTIVE MITIGATION MEASURES.—Not later than Janu-
ary 1, 2026, the Inspector General of the Department of 
Health and Human Services shall submit to Congress a 
report assessing fraud risks relating to claims for clinical 
diagnostic laboratory tests for which payment may be 
made under section 1834A of the Social Security Act (42 
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269 
U.S.C. 1395m–1) and effective tools for reducing such 
fraudulent claims. The report may include information re-
garding— 
(1) which, if any, clinical diagnostic laboratory 
tests are identified as being at high risk of fraudu-
lent claims, and an analysis of the factors that con-
tribute to such risk; 
(2) with respect to a clinical diagnostic labora-
tory test identified under paragraph (1) as being at 
high risk of fraudulent claims— 
(A) the amount payable under such section 
1834A with respect to such test; 
(B) the number of such tests furnished to 
individuals enrolled under part B of title XVIII 
of the Social Security Act (42 U.S.C. 1395j et 
seq.); 
(C) whether an order for such a test was 
more likely to come from a provider with whom 
the individual involved did not have a prior re-
lationship, as determined on the basis of prior 
payment experience; and 
(D) the frequency with which a claim for 
payment under such section 1834A included the 
payment modifier identified by code 59 or 91; 
and 
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(3) suggested strategies for reducing the num-
ber of fraudulent claims made with respect to tests 
so identified as being at high risk, including— 
(A) an analysis of whether the Centers for 
Medicare & Medicaid Services can detect aber-
rant billing patterns with respect to such tests 
in a timely manner; 
(B) any strategies for identifying and mon-
itoring the providers who are outliers with re-
spect to the number of such tests that such pro-
viders order; and 
(C) targeted education efforts to mitigate 
improper billing for such tests; and 
(4) such other information as the Inspector 
General determines appropriate. 
SEC. 213. GUIDANCE ON FURNISHING SERVICES VIA TELE-
HEALTH TO INDIVIDUALS WITH LIMITED 
ENGLISH PROFICIENCY. 
(a) IN GENERAL.—Not later than 1 year after the 
date of the enactment of this section, the Secretary of 
Health and Human Services, in consultation with 1 or 
more entities from each of the categories described in 
paragraphs (1) through (7) of subsection (b), shall issue 
and disseminate, or update and revise as applicable, guid-
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271 
ance for the entities described in such subsection on the 
following: 
(1) Best practices on facilitating and inte-
grating use of interpreters during a telemedicine ap-
pointment. 
(2) Best practices on providing accessible in-
structions on how to access telecommunications sys-
tems (as such term is used for purposes of section 
1834(m) of the Social Security Act (42 U.S.C. 
1395m(m)) for individuals with limited English pro-
ficiency. 
(3) Best practices on improving access to dig-
ital patient portals for individuals with limited 
English proficiency. 
(4) Best practices on integrating the use of 
video platforms that enable multi-person video calls 
furnished via a telecommunications system for pur-
poses of providing interpretation during a telemedi-
cine appointment for an individual with limited 
English proficiency. 
(5) Best practices for providing patient mate-
rials, communications, and instructions in multiple 
languages, including text message appointment re-
minders and prescription information. 
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272 
(b) ENTITIES DESCRIBED.—For purposes of sub-
section (a), an entity described in this subsection is an 
entity in 1 or more of the following categories: 
(1) Health information technology service pro-
viders, including— 
(A) electronic medical record companies; 
(B) remote patient monitoring companies; 
and 
(C) telehealth or mobile health vendors and 
companies. 
(2) Health care providers, including— 
(A) physicians; and 
(B) hospitals. 
(3) Health insurers. 
(4) Language service companies. 
(5) Interpreter or translator professional asso-
ciations. 
(6) Health and language services quality certifi-
cation organizations. 
(7) Patient and consumer advocates, including 
such advocates that work with individuals with lim-
ited English proficiency. 
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273 
SEC. 214. IN-HOME CARDIOPULMONARY REHABILITATION 
FLEXIBILITIES. 
(a) IN GENERAL.—Section 1861(eee)(2) of the Social 
Security Act (42 U.S.C. 1395x(eee)(2)) is amended— 
(1) in subparagraph (A)(ii), by inserting ‘‘(in-
cluding, with respect to items and services furnished 
through audio and video real-time communications 
technology (excluding audio-only) on or after April 
1, 2025, and before January 1, 2027, in the home 
of an individual who is an outpatient of the hos-
pital)’’ after ‘‘outpatient basis’’; and 
(2) in subparagraph (B), by inserting ‘‘(includ-
ing, with respect to items and services furnished 
through audio and video real-time communications 
technology on or after April 1, 2025, and before 
January 1, 2027, the virtual presence of such physi-
cian, physician assistant, nurse practitioner, or clin-
ical nurse specialist)’’ after ‘‘under the program’’. 
(b) PROGRAM INSTRUCTION AUTHORITY.—Notwith-
standing any other provision of law, the Secretary of 
Health and Human Services may implement the amend-
ments made by this section by program instruction or oth-
erwise. 
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274 
SEC. 215. INCLUSION OF VIRTUAL DIABETES PREVENTION 
PROGRAM SUPPLIERS IN MDPP EXPANDED 
MODEL. 
(a) IN GENERAL.—Not later than January 1, 2026, 
the Secretary shall revise the regulations under parts 410 
and 424 of title 42, Code of Federal Regulations, to pro-
vide that, for the period beginning January 1, 2026, and 
ending December 31, 2030— 
(1) an entity may participate in the MDPP by 
offering only online MDPP services via synchronous 
or asynchronous technology or telecommunications if 
such entity meets the conditions for enrollment as 
an 
MDPP 
supplier 
(as 
specified 
in 
section 
424.205(b) of title 42, Code of Federal Regulations 
(or a successor regulation)); 
(2) if an entity participates in the MDPP in the 
manner described in paragraph (1)— 
(A) the administrative location of such en-
tity shall be the address of the entity on file 
under the Diabetes Prevention Recognition Pro-
gram; and 
(B) in the case of online MDPP services 
furnished by such entity to an MDPP bene-
ficiary who was not located in the same State 
as the entity at the time such services were fur-
nished, the entity shall not be prohibited from 
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275 
submitting a claim for payment for such serv-
ices solely by reason of the location of such ben-
eficiary at such time; and 
(3) no limit is applied on the number of times 
an individual may enroll in the MDPP. 
(b) DEFINITIONS.—In this section: 
(1) MDPP.—The term ‘‘MDPP’’ means the 
Medicare Diabetes Prevention Program conducted 
under section 1115A of the Social Security Act (42 
U.S.C. 1315a), as described in the final rule pub-
lished in the Federal Register entitled ‘‘Medicare 
and Medicaid Programs; CY 2024 Payment Policies 
Under the Physician Fee Schedule and Other 
Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; 
Medicare Advantage; Medicare and Medicaid Pro-
vider and Supplier Enrollment Policies; and Basic 
Health Program’’ (88 Fed. Reg. 78818 (November 
16, 2023)) (or a successor regulation). 
(2) REGULATORY TERMS.—The terms ‘‘Diabe-
tes Prevention Recognition Program’’, ‘‘full CDC 
DPRP recognition’’, ‘‘MDPP beneficiary’’, ‘‘MDPP 
services’’, and ‘‘MDPP supplier’’ have the meanings 
given each such term in section 410.79(b) of title 
42, Code of Federal Regulations. 
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276 
(3) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
SEC. 216. MEDICATION-INDUCED MOVEMENT DISORDER 
OUTREACH AND EDUCATION. 
Not later than January 1, 2026, the Secretary shall 
use existing communications mechanisms to provide edu-
cation and outreach to physicians and appropriate non- 
physician practitioners participating under the Medicare 
program under title XVIII of the Social Security Act (42 
U.S.C. 1395 et seq.) with respect to periodic screening for 
medication-induced movement disorders that are associ-
ated with the treatment of mental health disorders in at- 
risk patients, as well as resources related to clinical guide-
lines and best practices for furnishing such screening serv-
ices through telehealth. Such education and outreach shall 
include information on how to account for such screening 
services in evaluation and management code selection. The 
Secretary shall, to the extent practicable, seek input from 
relevant stakeholders to inform such education and out-
reach. Such education and outreach may also address 
other relevant screening services furnished through tele-
health, as the Secretary determines appropriate. 
SEC. 217. REPORT ON WEARABLE MEDICAL DEVICES. 
Not later than 18 months after the date of the enact-
ment of this Act, the Comptroller General of the United 
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States shall conduct a technology assessment of, and sub-
mit to Congress a report on, the capabilities and limita-
tions of wearable medical devices used to support clinical 
decision-making. Such report shall include a description 
of— 
(1) the potential for such devices to accurately 
prescribe treatments; 
(2) an examination of the benefits and chal-
lenges of artificial intelligence to augment such ca-
pabilities; and 
(3) policy options to enhance the benefits and 
mitigate potential challenges of developing or using 
such devices. 
SEC. 218. EXTENSION OF TEMPORARY INCLUSION OF AU-
THORIZED ORAL ANTIVIRAL DRUGS AS COV-
ERED PART D DRUGS. 
Section 1860D–2(e)(1)(C) of the Social Security Act 
(42 U.S.C. 1395w–102(e)(1)(C)) is amended by striking 
‘‘March 31, 2025’’ and inserting ‘‘December 31, 2025’’. 
SEC. 219. EXTENSION OF ADJUSTMENT TO CALCULATION 
OF HOSPICE CAP AMOUNT. 
Section 1814(i)(2)(B) of the Social Security Act (42 
U.S.C. 1395f(i)(2)(B)) is amended— 
(1) in clause (ii), by striking ‘‘2033’’ and in-
serting ‘‘2034’’; and 
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(2) in clause (iii), by striking ‘‘2033’’ and in-
serting ‘‘2034’’. 
SEC. 220. MULTIYEAR CONTRACTING AUTHORITY FOR 
MEDPAC AND MACPAC. 
Section 3904 of title 41, United States Code, is 
amended by adding at the end the following new sub-
sections: 
‘‘(i) THE MEDICARE PAYMENT ADVISORY COMMIS-
SION.—The Medicare Payment Advisory Commission may 
use available funds to enter into contracts for the procure-
ment of severable services for a period that begins in one 
fiscal year and ends in the next fiscal year and may enter 
into multiyear contracts for the acquisition of property 
and services to the same extent as executive agencies 
under the authority of sections 3902 and 3903 of this 
title. 
‘‘(j) THE MEDICAID AND CHIP PAYMENT AND AC-
CESS COMMISSION.—The Medicaid and CHIP Payment 
and Access Commission may use available funds to enter 
into contracts for the procurement of severable services 
for a period that begins in one fiscal year and ends in 
the next fiscal year and may enter into multiyear contracts 
for the acquisition of property and services to the same 
extent as executive agencies under the authority of sec-
tions 3902 and 3903 of this title.’’. 
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SEC. 
221. 
CONTRACTING 
PARITY 
FOR 
MEDPAC 
AND 
MACPAC. 
In fiscal year 2025 and thereafter, for all contracts 
for goods and services to which the Medicare and Payment 
Advisory Commission or the Medicaid and CHIP Payment 
and Access Commission is a party, the following Federal 
Acquisition Regulation (FAR) clauses will apply: FAR 
52.232–39 and FAR 52.233–4 (or a successor clause). 
SEC. 222. ADJUSTMENTS TO MEDICARE PART D COST-SHAR-
ING REDUCTIONS FOR LOW-INCOME INDIVID-
UALS. 
Section 1860D–14(a) of the Social Security Act (42 
U.S.C. 1395w–114(a)) is amended— 
(1) in paragraph (1)(D)(ii), by striking ‘‘that 
does not exceed $1 for’’ and all that follows through 
the period at the end and inserting ‘‘that does not 
exceed— 
‘‘(I) for a plan year before 
2027— 
‘‘(aa) for a generic drug or a 
preferred drug that is a multiple 
source drug (as defined in section 
1927(k)(7)(A)(i)), $1 or, if less, 
the copayment amount applicable 
to an individual under clause 
(iii); and 
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‘‘(bb) for any other drug, $3 
or, if less, the copayment amount 
applicable to an individual under 
clause (iii); and 
‘‘(II) for plan year 2027 and 
each subsequent plan year— 
‘‘(aa) for a generic drug, $0; 
‘‘(bb) for a preferred drug 
that is a multiple source drug (as 
defined 
in 
section 
1927(k)(7)(A)(i)), 
the 
dollar 
amount applied under this clause 
for such a drug for the preceding 
plan year, increased by the an-
nual percentage increase in the 
consumer price index (all items; 
U.S. city average) as of Sep-
tember of such preceding year, 
or, if less, the copayment amount 
applicable to an individual under 
clause (iii); and 
‘‘(cc) for a drug not de-
scribed in either item (aa) or 
(bb), the dollar amount applied 
under this clause for such a drug 
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for the preceding plan year, in-
creased in the manner specified 
in item (bb), or, if less, the co-
payment amount applicable to an 
individual under clause (iii). 
Any amount established under item (bb) or 
(cc) of subclause (II), that is based on an 
increase of $1 or $3, that is not a multiple 
of 5 cents or 10 cents, respectively, shall 
be rounded to the nearest multiple of 5 
cents or 10 cents, respectively.’’; and 
(2) in paragraph (4)(A)(ii), by inserting ‘‘(be-
fore 2027)’’ after ‘‘a subsequent year’’. 
SEC. 223. REQUIRING ENHANCED AND ACCURATE LISTS OF 
(REAL) HEALTH PROVIDERS ACT. 
(a) IN GENERAL.—Section 1852(c) of the Social Se-
curity Act (42 U.S.C. 1395w–22(c)) is amended— 
(1) in paragraph (1)(C)— 
(A) by striking ‘‘plan, and any’’ and insert-
ing ‘‘plan, any’’; and 
(B) by inserting the following before the 
period at the end: ‘‘, and, in the case of a speci-
fied MA plan (as defined in paragraph (3)(C)), 
for plan year 2027 and subsequent plan years, 
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the information described in paragraph (3)(B)’’; 
and 
(2) by adding at the end the following new 
paragraph: 
‘‘(3) PROVIDER DIRECTORY ACCURACY.— 
‘‘(A) IN GENERAL.—For plan year 2027 
and subsequent plan years, each MA organiza-
tion offering a specified MA plan (as defined in 
subparagraph (C)) shall, for each such plan of-
fered by the organization— 
‘‘(i) maintain, on a publicly available 
internet website, an accurate provider di-
rectory that includes the information de-
scribed in subparagraph (B); 
‘‘(ii) not less frequently than once 
every 90 days (or, in the case of a hospital 
or any other facility determined appro-
priate by the Secretary, at a lesser fre-
quency specified by the Secretary but in no 
case less frequently than once every 12 
months), verify the provider directory in-
formation of each provider listed in such 
directory and, if applicable, update such 
provider directory information; 
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‘‘(iii) if the organization is unable to 
verify such information with respect to a 
provider, include in such directory an indi-
cation that the information of such pro-
vider may not be up to date; and 
‘‘(iv) remove a provider from such di-
rectory within 5 business days if the orga-
nization determines that the provider is no 
longer a provider participating in the net-
work of such plan. 
‘‘(B) PROVIDER
DIRECTORY
INFORMA-
TION.—The information described in this sub-
paragraph is information enrollees may need to 
access covered benefits from a provider with 
which such organization offering such plan has 
an agreement for furnishing items and services 
covered under such plan such as name, spe-
cialty, contact information, primary office or fa-
cility address, whether the provider is accepting 
new patients, accommodations for people with 
disabilities, cultural and linguistic capabilities, 
and telehealth capabilities. 
‘‘(C) SPECIFIED MA PLAN.—In this para-
graph, the term ‘specified MA plan’ means— 
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‘‘(i) a network-based plan (as defined 
in subsection (d)(5)(C)); or 
‘‘(ii) a Medicare Advantage private 
fee-for-service plan (as defined in section 
1859(b)(2)) that meets the access stand-
ards under subsection (d)(4), in whole or 
in part, through entering into contracts or 
agreements as provided for under subpara-
graph (B) of such subsection.’’. 
(b) ACCOUNTABILITY
FOR PROVIDER DIRECTORY 
ACCURACY.— 
(1) COST SHARING FOR SERVICES FURNISHED 
BASED ON RELIANCE ON INCORRECT PROVIDER DI-
RECTORY
INFORMATION.—Section 1852(d) of the 
Social Security Act (42 U.S.C. 1395w–22(d)) is 
amended— 
(A) in paragraph (1)(C)— 
(i) in clause (ii), by striking ‘‘or’’ at 
the end; 
(ii) in clause (iii), by striking the 
semicolon at the end and inserting ‘‘, or’’; 
and 
(iii) by adding at the end the fol-
lowing new clause: 
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‘‘(iv) the services are furnished by a 
provider that is not participating in the 
network of a specified MA plan (as defined 
in subsection (c)(3)(C)) but is listed in the 
provider directory of such plan on the date 
on which the appointment is made, as de-
scribed in paragraph (7)(A);’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(7) COST SHARING FOR SERVICES FURNISHED 
BASED ON RELIANCE ON INCORRECT PROVIDER DI-
RECTORY INFORMATION.— 
‘‘(A) IN GENERAL.—For plan year 2027 
and subsequent plan years, if an enrollee is fur-
nished an item or service by a provider that is 
not participating in the network of a specified 
MA plan (as defined in subsection (c)(3)(C)) 
but is listed in the provider directory of such 
plan (as required to be provided to an enrollee 
pursuant to subsection (c)(1)(C)) on the date 
on which the appointment is made, and if such 
item or service would otherwise be covered 
under such plan if furnished by a provider that 
is participating in the network of such plan, the 
MA organization offering such plan shall ensure 
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that the enrollee is only responsible for the less-
er of— 
‘‘(i) the amount of cost sharing that 
would apply if such provider had been par-
ticipating in the network of such plan; or 
‘‘(ii) the amount of cost sharing that 
would otherwise apply (without regard to 
this subparagraph). 
‘‘(B) NOTIFICATION REQUIREMENT.—For 
plan year 2027 and subsequent plan years, each 
MA organization that offers a specified MA 
plan shall— 
‘‘(i) notify enrollees of their cost-shar-
ing protections under this paragraph and 
make such notifications, to the extent 
practicable, by not later than the first day 
of an annual, coordinated election period 
under section 1851(e)(3) with respect to a 
year; 
‘‘(ii) include information regarding 
such cost-sharing protections in the pro-
vider directory of each specified MA plan 
offered by the MA organization.; and 
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‘‘(iii) notify enrollees of their cost- 
sharing protections under this paragraph 
in an explanation of benefits.’’. 
(2) REQUIRED
PROVIDER
DIRECTORY
ACCU-
RACY ANALYSIS AND REPORTS.— 
(A) IN GENERAL.—Section 1857(e) of the 
Social Security Act (42 U.S.C. 1395w–27(e)) is 
amended by adding at the end the following 
new paragraph: 
‘‘(6) PROVIDER
DIRECTORY
ACCURACY
ANAL-
YSIS AND REPORTS.— 
‘‘(A) IN GENERAL.—Beginning with plan 
years beginning on or after January 1, 2027, 
subject to subparagraph (C), a contract under 
this section with an MA organization shall re-
quire the organization, for each specified MA 
plan (as defined in section 1852(c)(3)(C)) of-
fered by the organization to annually do the fol-
lowing: 
‘‘(i) Conduct an analysis estimating 
the accuracy of the provider directory in-
formation of such plan using a random 
sample of providers included in such pro-
vider directory as follows: 
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‘‘(I) Such a random sample shall 
include a random sample of each spe-
cialty of providers with a high inaccu-
racy rate of provider directory infor-
mation relative to other specialties of 
providers, as determined by the Sec-
retary. 
‘‘(II) For purposes of subclause 
(I), one type of specialty may be pro-
viders specializing in mental health or 
substance use disorder treatment. 
‘‘(ii) Submit to the Secretary a report 
containing the results of the analysis con-
ducted under clause (i), including an accu-
racy score for such provider directory in-
formation (as determined using a plan 
verification method specified by the Sec-
retary under subparagraph (B)(i)). 
‘‘(B) 
DETERMINATION
OF
ACCURACY 
SCORE.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall specify plan verification methods, 
such as using telephonic verification or 
other approaches using data sources main-
tained by an MA organization or using 
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publicly available data sets, that MA orga-
nizations may use for estimating accuracy 
scores of the provider directory information 
of specified MA plans offered by such or-
ganizations. 
‘‘(ii) 
ACCURACY
SCORE
METHOD-
OLOGY.—With respect to each such meth-
od specified by the Secretary as described 
in clause (i), the Secretary shall specify a 
methodology for MA organizations to use 
in estimating such accuracy scores. Each 
such methodology shall take into account 
the administrative burden on plans and 
providers and the relative importance of 
certain provider directory information on 
enrollee ability to access care. 
‘‘(C) EXCEPTION.—The Secretary may 
waive the requirements of this paragraph in the 
case of a specified MA plan with low enrollment 
(as defined by the Secretary). 
‘‘(D) 
TRANSPARENCY.—Beginning 
with 
plan years beginning on or after January 1, 
2028, the Secretary shall post accuracy scores 
(as reported under subparagraph (A)(ii)), in a 
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machine readable file, on the internet website of 
the Centers for Medicare & Medicaid Services.’’. 
(B) PROVISION
OF
INFORMATION
TO 
BENEFICIARIES.—Section 1851(d)(4) of the So-
cial Security Act (42 U.S.C. 1395w–21(d)(4)) 
is amended by adding at the end the following 
new subparagraph: 
‘‘(F) PROVIDER
DIRECTORY.—Beginning 
with plan years beginning on or after January 
1, 2028, the accuracy score of the plan’s pro-
vider directory (as reported under section 
1857(e)(6)(A)(ii)) listed prominently on the 
plan’s provider directory.’’. 
(C) FUNDING.—In addition to amounts 
otherwise available, there is appropriated to the 
Centers for Medicare & Medicaid Services Pro-
gram Management Account, out of any money 
in the Treasury not otherwise appropriated, 
$4,000,000 for fiscal year 2025, to remain 
available until expended, to carry out the 
amendments made by this paragraph. 
(3) GAO STUDY AND REPORT.— 
(A) ANALYSIS.—The Comptroller General 
of the United States (in this paragraph referred 
to as the ‘‘Comptroller General’’) shall conduct 
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a study of the implementation of the amend-
ments made by paragraphs (1) and (2). To the 
extent data are available and reliable, such 
study shall include an analysis of— 
(i) the use of cost-sharing protections 
required under section 1852(d)(7)(A) of 
the Social Security Act, as added by para-
graph (1); 
(ii) the trends in provider directory in-
formation accuracy scores under section 
1857(e)(6)(A)(ii) of the Social Security 
Act (as added by paragraph (2)(A)), both 
overall and among providers specializing in 
mental health or substance use disorder 
treatment; 
(iii) provider response rates by plan 
verification methods; 
(iv) administrative costs to providers 
and Medicare Advantage organizations; 
and 
(v) other items determined appro-
priate by the Comptroller General. 
(B) REPORT.—Not later than January 15, 
2032, the Comptroller General shall submit to 
Congress a report containing the results of the 
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study conducted under subparagraph (A), to-
gether with recommendations for such legisla-
tion and administrative action as the Comp-
troller General determines appropriate. 
(c) GUIDANCE
ON MAINTAINING ACCURATE PRO-
VIDER DIRECTORIES.— 
(1) STAKEHOLDER MEETING.— 
(A) IN
GENERAL.—Not later than 3 
months after the date of enactment of this Act, 
the Secretary of Health and Human Services 
(referred to in this subsection as the ‘‘Sec-
retary’’) shall hold a public meeting to receive 
input on approaches for maintaining accurate 
provider directories for Medicare Advantage 
plans under part C of title XVIII of the Social 
Security Act (42 U.S.C. 1395w–21 et seq.), in-
cluding input on approaches for reducing ad-
ministrative burden, such as data standardiza-
tion, and best practices to maintain accurate 
provider directory information. 
(B) PARTICIPANTS.—Participants of the 
meeting under subparagraph (A) shall include 
representatives from the Centers for Medicare & 
Medicaid Services and the Assistant Secretary 
for Technology Policy and Office of the Na-
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tional Coordinator for Health Information 
Technology. Such meeting shall be open to the 
public. To the extent practicable, the Secretary 
shall include health care providers, companies 
that specialize in relevant technologies, health 
insurers, and patient advocates. 
(2) GUIDANCE TO MEDICARE ADVANTAGE OR-
GANIZATIONS.—Not later than 12 months after the 
date of enactment of this Act, the Secretary shall 
issue guidance to Medicare Advantage organizations 
offering Medicare Advantage plans under part C of 
title XVIII of the Social Security Act (42 U.S.C. 
1395w–21 et seq.) on maintaining accurate provider 
directories for such plans, taking into consideration 
input received during the stakeholder meeting under 
paragraph (1). Such guidance may include the fol-
lowing, as determined appropriate by the Secretary: 
(A) Best practices for Medicare Advantage 
organizations on how to work with providers to 
maintain the accuracy of provider directories 
and reduce provider and Medicare Advantage 
organization burden with respect to maintaining 
the accuracy of provider directories. 
(B) Information on data sets and data 
sources with information that could be used by 
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Medicare Advantage organizations to maintain 
accurate provider directories. 
(C) Approaches for utilizing data sources 
maintained by Medicare Advantage organiza-
tions and publicly available data sets to main-
tain accurate provider directories. 
(D) Information to be included in provider 
directories that may be useful for Medicare 
beneficiaries to assess plan networks when se-
lecting a plan and accessing providers partici-
pating in plan networks during the plan year. 
(3) GUIDANCE
TO
PART
B
PROVIDERS.—Not 
later than 12 months after the date of enactment of 
this Act, the Secretary shall issue guidance to pro-
viders of services and suppliers who furnish items or 
services for which benefits are available under part 
B of title XVIII of the Social Security Act (42 
U.S.C. 1395j et seq.) on when to update the Na-
tional Plan and Provider Enumeration System for 
information changes. 
SEC. 224. MEDICARE COVERAGE OF MULTI-CANCER EARLY 
DETECTION SCREENING TESTS. 
(a) COVERAGE.—Section 1861 of the Social Security 
Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
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(A) by striking the semicolon at the end of 
subparagraph (JJ) and inserting ‘‘; and’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(KK) multi-cancer early detection screen-
ing tests (as defined in subsection (nnn));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(nnn) MULTI-CANCER EARLY DETECTION SCREEN-
ING TESTS.— 
‘‘(1) IN
GENERAL.—The term ‘multi-cancer 
early detection screening test’ means a test fur-
nished to an individual for the concurrent detection 
of multiple cancer types across multiple organ sites 
on or after January 1, 2029, that— 
‘‘(A) is cleared under section 510(k), clas-
sified under section 513(f)(2), or approved 
under section 515 of the Federal Food, Drug, 
and Cosmetic Act; 
‘‘(B) is— 
‘‘(i) a genomic sequencing blood or 
blood product test that includes the anal-
ysis of cell-free nucleic acids; or 
‘‘(ii) a test based on samples of bio-
logical material that provide results com-
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parable to those obtained with a test de-
scribed in clause (i), as determined by the 
Secretary; and 
‘‘(C) the Secretary determines is— 
‘‘(i) reasonable and necessary for the 
prevention or early detection of an illness 
or disability; and 
‘‘(ii) appropriate for individuals enti-
tled to benefits under part A or enrolled 
under part B. 
‘‘(2) NCD PROCESS.—In making determina-
tions under paragraph (1)(C) regarding the coverage 
of a new test, the Secretary shall use the process for 
making national coverage determinations (as defined 
in section 1869(f)(1)(B)) under this title.’’. 
(b) PAYMENT AND STANDARDS FOR MULTI-CANCER 
EARLY DETECTION SCREENING TESTS.— 
(1) IN GENERAL.—Section 1834 of the Social 
Security Act (42 U.S.C. 1395m) is amended by add-
ing at the end the following new subsection: 
‘‘(aa) PAYMENT AND STANDARDS FOR MULTI-CAN-
CER EARLY DETECTION SCREENING TESTS.— 
‘‘(1) 
PAYMENT
AMOUNT.—The 
payment 
amount for a multi-cancer early detection screening 
test (as defined in section 1861(nnn)) is— 
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‘‘(A) with respect to such a test furnished 
before January 1, 2031, equal to the payment 
amount in effect on the date of the enactment 
of this subsection for a multi-target stool 
screening DNA test covered pursuant to section 
1861(pp)(1)(D); and 
‘‘(B) with respect to such a test furnished 
on or after January 1, 2031, equal to the lesser 
of— 
‘‘(i) the amount described in subpara-
graph (A); or 
‘‘(ii) the payment amount determined 
for such test under section 1834A. 
‘‘(2) LIMITATIONS.— 
‘‘(A) IN GENERAL.—No payment may be 
made under this part for a multi-cancer early 
detection screening test furnished during a year 
to an individual if— 
‘‘(i) such individual— 
‘‘(I) is under 50 years of age; or 
‘‘(II) as of January 1 of such 
year, has attained the age specified in 
subparagraph (B) for such year; or 
‘‘(ii) such a test was furnished to the 
individual during the previous 11 months. 
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‘‘(B) AGE
SPECIFIED.—For purposes of 
subparagraph (A)(i)(II), the age specified in 
this subparagraph is— 
‘‘(i) for 2029, 65 years of age; and 
‘‘(ii) for a succeeding year, the age 
specified in this subparagraph for the pre-
ceding year, increased by 1 year. 
‘‘(C) STANDARDS
FOLLOWING
USPSTF 
RATING OF A OR B.—In the case of a multi-can-
cer early detection screening test that is rec-
ommended with a grade of A or B by the 
United States Preventive Services Task Force, 
beginning on the date on which coverage for 
such test is provided pursuant to section 
1861(ddd)(1), the preceding provisions of this 
paragraph shall not apply.’’. 
(2) CONFORMING AMENDMENTS.— 
(A) Section 1833 of the Social Security 
Act (42 U.S.C. 1395l) is amended— 
(i) in subsection (a)— 
(I) in paragraph (1)(D)(i)(I), by 
striking ‘‘section 1834(d)(1)’’ and in-
serting ‘‘subsection (d)(1) or (aa) of 
section 1834’’; and 
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(II) in paragraph (2)(D)(i)(I), by 
striking ‘‘section 1834(d)(1)’’ and in-
serting ‘‘subsection (d)(1) or (aa) of 
section 1834’’; and 
(ii) in subsection (h)(1)(A), by strik-
ing ‘‘section 1834(d)(1)’’ and inserting 
‘‘subsections (d)(1) and (aa) of section 
1834’’. 
(B) Section 1862(a)(1)(A) of the Social 
Security Act (42 U.S.C. 1395y(a)(1)(A)) is 
amended— 
(i) by striking ‘‘or additional preven-
tive services’’ and inserting ‘‘, additional 
preventive services’’; and 
(ii) by inserting ‘‘, or multi-cancer 
early detection screening tests (as defined 
in section 1861(nnn))’’ after ‘‘(as de-
scribed in section 1861(ddd)(1))’’. 
(c) RULE OF CONSTRUCTION RELATING TO OTHER 
CANCER SCREENING TESTS.—Nothing in this section, in-
cluding the amendments made by this section, shall be 
construed— 
(1) in the case of an individual who undergoes 
a multi-cancer early detection screening test, to af-
fect coverage under part B of title XVIII of the So-
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cial Security Act for other cancer screening tests 
covered under such title, such as screening tests for 
breast, cervical, colorectal, lung, or prostate cancer; 
or 
(2) in the case of an individual who undergoes 
another cancer screening test, to affect coverage 
under such part for a multi-cancer early detection 
screening test or the use of such a test as a diag-
nostic or confirmatory test for a result of the other 
cancer screening test. 
SEC. 225. MEDICARE COVERAGE OF EXTERNAL INFUSION 
PUMPS 
AND 
NON-SELF-ADMINISTRABLE 
HOME INFUSION DRUGS. 
(a) IN GENERAL.—Section 1861(n) of the Social Se-
curity Act (42 U.S.C. 1395x(n)) is amended by adding 
at the end the following new sentence: ‘‘Beginning with 
the first calendar quarter beginning on or after the date 
that is 1 year after the date of the enactment of this sen-
tence, an external infusion pump and associated home in-
fusion drug (as defined in subsection (iii)(3)(C)) or other 
associated supplies that do not meet the appropriate for 
use in the home requirement applied to the definition of 
durable medical equipment under section 414.202 of title 
42, Code of Federal Regulations (or any successor to such 
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regulation) shall be treated as meeting such requirement 
if each of the following criteria is satisfied: 
‘‘(1) The prescribing information approved by 
the Food and Drug Administration for the home in-
fusion drug associated with the pump instructs that 
the drug should be administered by or under the su-
pervision of a health care professional. 
‘‘(2) A qualified home infusion therapy supplier 
(as defined in subsection (iii)(3)(D)) administers or 
supervises the administration of the drug or biologi-
cal in a safe and effective manner in the patient’s 
home (as defined in subsection (iii)(3)(B)). 
‘‘(3) The prescribing information described in 
paragraph (1) instructs that the drug should be in-
fused at least 12 times per year— 
‘‘(A) intravenously or subcutaneously; or 
‘‘(B) at infusion rates that the Secretary 
determines would require the use of an external 
infusion pump.’’. 
(b) COST SHARING NOTIFICATION.—The Secretary 
of Health and Human Services shall ensure that patients 
are notified of the cost sharing for electing home infusion 
therapy compared to other applicable settings of care for 
the furnishing of infusion drugs under the Medicare pro-
gram. 
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302 
SEC. 226. ASSURING PHARMACY ACCESS AND CHOICE FOR 
MEDICARE BENEFICIARIES. 
(a) IN GENERAL.—Section 1860D–4(b)(1) of the So-
cial Security Act (42 U.S.C. 1395w–104(b)(1)) is amend-
ed by striking subparagraph (A) and inserting the fol-
lowing: 
‘‘(A) IN GENERAL.— 
‘‘(i) PARTICIPATION OF ANY WILLING 
PHARMACY.—A PDP sponsor offering a 
prescription drug plan shall permit any 
pharmacy that meets the standard contract 
terms and conditions under such plan to 
participate as a network pharmacy of such 
plan. 
‘‘(ii) CONTRACT TERMS AND CONDI-
TIONS.— 
‘‘(I) 
IN
GENERAL.—Notwith-
standing any other provision of law, 
for plan years beginning on or after 
January 1, 2028, in accordance with 
clause (i), contract terms and condi-
tions offered by such PDP sponsor 
shall be reasonable and relevant ac-
cording to standards established by 
the Secretary under subclause (II). 
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‘‘(II) 
STANDARDS.—Not 
later 
than the first Monday in April of 
2027, the Secretary shall establish 
standards for reasonable and relevant 
contract terms and conditions for pur-
poses of this clause. 
‘‘(III) REQUEST
FOR
INFORMA-
TION.—Not later than April 1, 2026, 
for purposes of establishing the stand-
ards under subclause (II), the Sec-
retary shall issue a request for infor-
mation to seek input on trends in pre-
scription drug plan and network phar-
macy contract terms and conditions, 
current prescription drug plan and 
network pharmacy contracting prac-
tices, whether pharmacy reimburse-
ment and dispensing fees paid by 
PDP sponsors to network pharmacies 
sufficiently cover the ingredient and 
operational costs of such pharmacies, 
the use and application of pharmacy 
quality measures by PDP sponsors for 
network pharmacies, PDP sponsor re-
strictions or limitations on the dis-
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pensing of covered part D drugs by 
network pharmacies (or any subsets of 
such pharmacies), PDP sponsor au-
diting practices for network phar-
macies, areas in current regulations or 
program guidance related to con-
tracting between prescription drug 
plans and network pharmacies requir-
ing clarification or additional speci-
ficity, factors for consideration in de-
termining the reasonableness and rel-
evance of contract terms and condi-
tions between prescription drug plans 
and network pharmacies, and other 
issues as determined appropriate by 
the Secretary.’’. 
(b) 
ESSENTIAL
RETAIL
PHARMACIES.—Section 
1860D–42 of the Social Security Act (42 U.S.C. 1395w– 
152) is amended by adding at the end the following new 
subsection: 
‘‘(e) ESSENTIAL RETAIL PHARMACIES.— 
‘‘(1) IN GENERAL.—With respect to plan years 
beginning on or after January 1, 2028, the Sec-
retary shall publish reports, at least once every 2 
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years until 2034, and periodically thereafter, that 
provide information, to the extent feasible, on— 
‘‘(A) trends in ingredient cost reimburse-
ment, dispensing fees, incentive payments and 
other fees paid by PDP sponsors offering pre-
scription drug plans and MA organizations of-
fering MA–PD plans under this part to essen-
tial retail pharmacies (as defined in paragraph 
(2)) with respect to the dispensing of covered 
part D drugs, including a comparison of such 
trends between essential retail pharmacies and 
pharmacies that are not essential retail phar-
macies; 
‘‘(B) trends in amounts paid to PDP spon-
sors offering prescription drug plans and MA 
organizations offering MA–PD plans under this 
part by essential retail pharmacies with respect 
to the dispensing of covered part D drugs, in-
cluding a comparison of such trends between 
essential retail pharmacies and pharmacies that 
are not essential retail pharmacies; 
‘‘(C) trends in essential retail pharmacy 
participation in pharmacy networks and pre-
ferred pharmacy networks for prescription drug 
plans offered by PDP sponsors and MA–PD 
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essential retail pharmacies, including informa-
tion on any patterns or trends in such compari-
son specific to certain types of covered part D 
drugs, such as generic drugs or drugs specified 
as specialty drugs by a PDP sponsor under a 
prescription drug plan or an MA organization 
under an MA–PD plan; and 
‘‘(G) a comparison of the information de-
scribed in subparagraphs (A) through (F) be-
tween essential retail pharmacies that are net-
work pharmacies for prescription drug plans of-
fered by PDP sponsors under this part and es-
sential retail pharmacies that are network phar-
macies for MA–PD plans offered by MA organi-
zations under this part. 
‘‘(2) DEFINITION OF ESSENTIAL RETAIL PHAR-
MACY.—In this subsection, the term ‘essential retail 
pharmacy’ means, with respect to a plan year, a re-
tail pharmacy that— 
‘‘(A) is not a pharmacy that is an affiliate 
as defined in paragraph (4); and 
‘‘(B) is located in— 
‘‘(i) a medically underserved area (as 
designated 
pursuant 
to 
section 
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308 
330(b)(3)(A) of the Public Health Service 
Act); 
‘‘(ii) a rural area in which there is no 
other retail pharmacy within 10 miles, as 
determined by the Secretary; 
‘‘(iii) a suburban area in which there 
is no other retail pharmacy within 2 miles, 
as determined by the Secretary; or 
‘‘(iv) an urban area in which there is 
no other retail pharmacy within 1 mile, as 
determined by the Secretary. 
‘‘(3) LIST
OF
ESSENTIAL
RETAIL
PHAR-
MACIES.— 
‘‘(A) PUBLICATION OF LIST OF ESSENTIAL 
RETAIL PHARMACIES.—For each plan year (be-
ginning with plan year 2028), the Secretary 
shall publish, on a publicly available internet 
website of the Centers for Medicare & Medicaid 
Services, a list of pharmacies that meet the cri-
teria described in subparagraphs (A) and (B) of 
paragraph (2) to be considered an essential re-
tail pharmacy. 
‘‘(B) REQUIRED SUBMISSIONS FROM PDP 
SPONSORS.—For each plan year (beginning 
with plan year 2028), each PDP sponsor offer-
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ing a prescription drug plan and each MA orga-
nization offering an MA–PD plan shall submit 
to the Secretary, for the purposes of deter-
mining retail pharmacies that meet the criterion 
specified in subparagraph (A) of paragraph (2), 
a list of retail pharmacies that are affiliates of 
such sponsor or organization, or are affiliates of 
a pharmacy benefit manager acting on behalf of 
such sponsor or organization, at a time, and in 
a form and manner, specified by the Secretary. 
‘‘(C) REPORTING BY PDP SPONSORS AND 
MA ORGANIZATIONS.—For each plan year be-
ginning with plan year 2027, each PDP sponsor 
offering a prescription drug plan and each MA 
organization offering an MA–PD plan under 
this part shall submit to the Secretary informa-
tion on incentive payments and other fees paid 
by such sponsor or organization to pharmacies, 
insofar as any such payments or fees are not 
otherwise reported, at a time, and in a form 
and manner, specified by the Secretary. 
‘‘(D) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may 
implement this paragraph by program instruc-
tion or otherwise. 
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‘‘(E) NONAPPLICATION
OF
PAPERWORK 
REDUCTION
ACT.—Chapter 35 of title 44, 
United States Code, shall not apply to the im-
plementation of this paragraph. 
‘‘(4) DEFINITION
OF
AFFILIATE; PHARMACY 
BENEFIT MANAGER.—In this subsection, the terms 
‘affiliate’ and ‘pharmacy benefit manager’ have the 
meaning given those terms in section 1860D– 
12(h)(7).’’. 
(c) ENFORCEMENT.— 
(1) IN
GENERAL.—Section 1860D–4(b)(1) of 
the Social Security Act (42 U.S.C. 1395w– 
104(b)(1)) is amended by adding at the end the fol-
lowing new subparagraph: 
‘‘(F) ENFORCEMENT OF STANDARDS FOR 
REASONABLE AND RELEVANT CONTRACT TERMS 
AND CONDITIONS.— 
‘‘(i) ALLEGATION SUBMISSION PROC-
ESS.— 
‘‘(I) IN
GENERAL.—Not later 
than January 1, 2028, the Secretary 
shall establish a process through 
which a pharmacy may submit to the 
Secretary an allegation of a violation 
by a PDP sponsor offering a prescrip-
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tion drug plan of the standards for 
reasonable 
and 
relevant 
contract 
terms and conditions under subpara-
graph (A)(ii), or of subclause (VIII) 
of this clause. 
‘‘(II) FREQUENCY
OF
SUBMIS-
SION.— 
‘‘(aa) IN GENERAL.—Except 
as provided in item (bb), the alle-
gation submission process under 
this clause shall allow pharmacies 
to submit any allegations of vio-
lations described in subclause (I) 
not more frequently than once 
per plan year per contract be-
tween a pharmacy and a PDP 
sponsor. 
‘‘(bb) ALLEGATIONS RELAT-
ING
TO
CONTRACT
MODIFICA-
TIONS.—In the case where a con-
tract between a pharmacy and a 
PDP sponsor is modified fol-
lowing the submission of allega-
tions by a pharmacy with respect 
to such contract and plan year, 
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the allegation submission process 
under this clause shall allow such 
pharmacy to submit an additional 
allegation related to those modi-
fications with respect to such 
contract and plan year. 
‘‘(III) ACCESS
TO
RELEVANT 
DOCUMENTS
AND
MATERIALS.—A 
PDP sponsor subject to an allegation 
under this clause— 
‘‘(aa) shall provide docu-
ments or materials, as specified 
by the Secretary, including con-
tract offers made by such spon-
sor to such pharmacy or cor-
respondence related to such of-
fers, to the Secretary at a time, 
and in a form and manner, speci-
fied by the Secretary; and 
‘‘(bb) shall not prohibit or 
otherwise limit the ability of a 
pharmacy to submit such docu-
ments or materials to the Sec-
retary for the purpose of submit-
ting an allegation or providing 
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313 
evidence for such an allegation 
under this clause. 
‘‘(IV) 
STANDARDIZED
TEM-
PLATE.—The Secretary shall establish 
a standardized template for phar-
macies to use for the submission of al-
legations described in subclause (I). 
Such template shall require that the 
submission include a certification by 
the pharmacy that the information in-
cluded is accurate, complete, and true 
to the best of the knowledge, informa-
tion, and belief of such pharmacy. 
‘‘(V) PREVENTING
FRIVOLOUS 
ALLEGATIONS.—In the case where the 
Secretary determines that a pharmacy 
has submitted frivolous allegations 
under this clause on a routine basis, 
the Secretary may temporarily pro-
hibit such pharmacy from using the 
allegation submission process under 
this clause, as determined appropriate 
by the Secretary. 
‘‘(VI) EXEMPTION
FROM
FREE-
DOM OF INFORMATION ACT.—Allega-
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tions submitted under this clause shall 
be exempt from disclosure under sec-
tion 552 of title 5, United States 
Code. 
‘‘(VII) 
RULE
OF
CONSTRUC-
TION.—Nothing in this clause shall be 
construed as limiting the ability of a 
pharmacy to pursue other legal ac-
tions or remedies, consistent with ap-
plicable Federal or State law, with re-
spect to a potential violation of a re-
quirement described in this subpara-
graph. 
‘‘(VIII) ANTI-RETALIATION
AND 
ANTI-COERCION.—Consistent with ap-
plicable Federal or State law, a PDP 
sponsor shall not— 
‘‘(aa) retaliate against a 
pharmacy for submitting any al-
legations under this clause; or 
‘‘(bb) 
coerce, 
intimidate, 
threaten, or interfere with the 
ability of a pharmacy to submit 
any such allegations. 
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315 
‘‘(ii) INVESTIGATION.—The Secretary 
shall investigate, as determined appro-
priate by the Secretary, allegations sub-
mitted pursuant to clause (i). 
‘‘(iii) ENFORCEMENT.— 
‘‘(I) IN GENERAL.—In the case 
where the Secretary determines that a 
PDP sponsor offering a prescription 
drug plan has violated the standards 
for reasonable and relevant contract 
terms and conditions under subpara-
graph (A)(ii), the Secretary may use 
authorities under sections 1857(g) 
and 1860D–12(b)(3)(E) to impose 
civil monetary penalties or other inter-
mediate sanctions. 
‘‘(II) 
APPLICATION
OF
CIVIL 
MONETARY
PENALTIES.—The provi-
sions of section 1128A (other than 
subsections (a) and (b)) shall apply to 
a civil monetary penalty under this 
clause in the same manner as such 
provisions apply to a penalty or pro-
ceeding under section 1128A(a).’’. 
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(2) 
CONFORMING
AMENDMENT.—Section 
1857(g)(1) of the Social Security Act (42 U.S.C. 
1395w–27(g)(1)) is amended— 
(A) in subparagraph (J), by striking ‘‘or’’ 
after the semicolon; 
(B) by redesignating subparagraph (K) as 
subparagraph (L); 
(C) by inserting after subparagraph (J), 
the following new subparagraph: 
‘‘(K) fails to comply with the standards for 
reasonable and relevant contract terms and con-
ditions under subparagraph (A)(ii) of section 
1860D–4(b)(1); or’’; 
(D) in subparagraph (L), as redesignated 
by subparagraph (B), by striking ‘‘through (J)’’ 
and inserting ‘‘through (K)’’; and 
(E) in the flush matter following subpara-
graph (L), as so redesignated, by striking ‘‘sub-
paragraphs (A) through (K)’’ and inserting 
‘‘subparagraphs (A) through (L)’’. 
(d) ACCOUNTABILITY OF PHARMACY BENEFIT MAN-
AGERS FOR VIOLATIONS OF REASONABLE AND RELEVANT 
CONTRACT TERMS AND CONDITIONS.— 
(1) IN GENERAL.—Section 1860D–12(b) of the 
Social Security Act (42 U.S.C. 1395w–112) is 
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317 
amended by adding at the end the following new 
paragraph: 
‘‘(9) ACCOUNTABILITY OF PHARMACY BENEFIT 
MANAGERS FOR VIOLATIONS OF REASONABLE AND 
RELEVANT
CONTRACT
TERMS
AND
CONDITIONS.— 
For plan years beginning on or after January 1, 
2028, each contract entered into with a PDP spon-
sor under this part with respect to a prescription 
drug plan offered by such sponsor shall provide that 
any pharmacy benefit manager acting on behalf of 
such sponsor has a written agreement with the PDP 
sponsor under which the pharmacy benefit manager 
agrees to reimburse the PDP sponsor for any 
amounts paid by such sponsor under section 1860D– 
4(b)(1)(F)(iii)(I) to the Secretary as a result of a 
violation described in such section if such violation 
is related to a responsibility delegated to the phar-
macy benefit manager by such PDP sponsor.’’. 
(2) MA–PD PLANS.—Section 1857(f)(3) of the 
Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(F) 
ACCOUNTABILITY
OF
PHARMACY 
BENEFIT MANAGERS FOR VIOLATIONS OF REA-
SONABLE AND RELEVANT CONTRACT TERMS.— 
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318 
For plan years beginning on or after January 
1, 2028, section 1860D–12(b)(9).’’. 
(e) BIENNIAL
REPORT
ON
ENFORCEMENT
AND 
OVERSIGHT OF PHARMACY ACCESS REQUIREMENTS.— 
Section 1860D–42 of the Social Security Act (42 U.S.C. 
1395w–152), as amended by subsection (b), is amended 
by adding at the end the following new subsection: 
‘‘(f) BIENNIAL REPORT
ON ENFORCEMENT
AND 
OVERSIGHT OF PHARMACY ACCESS REQUIREMENTS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of this subsection, and 
at least once every 2 years thereafter, the Secretary 
shall publish a report on enforcement and oversight 
actions and activities undertaken by the Secretary 
with respect to the requirements under section 
1860D–4(b)(1). 
‘‘(2) LIMITATION.—A report under paragraph 
(1) shall not disclose— 
‘‘(A) identifiable information about individ-
uals or entities unless such information is oth-
erwise publicly available; or 
‘‘(B) trade secrets with respect to any enti-
ties.’’. 
(f) FUNDING.—In addition to amounts otherwise 
available, there is appropriated to the Centers for Medi-
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care & Medicaid Services Program Management Account, 
out of any money in the Treasury not otherwise appro-
priated, $188,000,000 for fiscal year 2025, to remain 
available until expended, to carry out this section. 
SEC. 227. MODERNIZING AND ENSURING PBM ACCOUNT-
ABILITY. 
(a) IN GENERAL.— 
(1) 
PRESCRIPTION
DRUG
PLANS.—Section 
1860D–12 of the Social Security Act (42 U.S.C. 
1395w–112) is amended by adding at the end the 
following new subsection: 
‘‘(h) REQUIREMENTS RELATING TO PHARMACY BEN-
EFIT MANAGERS.—For plan years beginning on or after 
January 1, 2028: 
‘‘(1) AGREEMENTS WITH PHARMACY BENEFIT 
MANAGERS.—Each contract entered into with a 
PDP sponsor under this part with respect to a pre-
scription drug plan offered by such sponsor shall 
provide that any pharmacy benefit manager acting 
on behalf of such sponsor has a written agreement 
with the PDP sponsor under which the pharmacy 
benefit manager, and any affiliates of such phar-
macy benefit manager, as applicable, agree to meet 
the following requirements: 
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320 
‘‘(A) NO INCOME OTHER THAN BONA FIDE 
SERVICE FEES.— 
‘‘(i) IN
GENERAL.—The pharmacy 
benefit manager and any affiliate of such 
pharmacy benefit manager shall not derive 
any remuneration with respect to any serv-
ices provided on behalf of any entity or in-
dividual, in connection with the utilization 
of covered part D drugs, from any such en-
tity or individual other than bona fide serv-
ice fees, subject to clauses (ii) and (iii). 
‘‘(ii) INCENTIVE PAYMENTS.—For the 
purposes of this subsection, an incentive 
payment (as determined by the Secretary) 
paid by a PDP sponsor to a pharmacy 
benefit manager that is performing serv-
ices on behalf of such sponsor shall be 
deemed a ‘bona fide service fee’ (even if 
such payment does not otherwise meet the 
definition of such term under paragraph 
(7)(B)) if such payment is a flat dollar 
amount, is consistent with fair market 
value (as specified by the Secretary), is re-
lated to services actually performed by the 
pharmacy benefit manager or affiliate of 
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such pharmacy benefit manager, on behalf 
of the PDP sponsor making such payment, 
in connection with the utilization of cov-
ered part D drugs, and meets additional 
requirements, if any, as determined appro-
priate by the Secretary. 
‘‘(iii) CLARIFICATION
ON
REBATES 
AND DISCOUNTS USED TO LOWER COSTS 
FOR COVERED PART D DRUGS.—Rebates, 
discounts, and other price concessions re-
ceived by a pharmacy benefit manager or 
an affiliate of a pharmacy benefit manager 
from manufacturers, even if such price 
concessions are calculated as a percentage 
of a drug’s price, shall not be considered a 
violation of the requirements of clause (i) 
if they are fully passed through to a PDP 
sponsor and are compliant with all regu-
latory and subregulatory requirements re-
lated to direct and indirect remuneration 
for manufacturer rebates under this part, 
including in cases where a PDP sponsor is 
acting as a pharmacy benefit manager on 
behalf of a prescription drug plan offered 
by such PDP sponsor. 
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‘‘(iv) EVALUATION OF REMUNERATION 
ARRANGEMENTS.—Components of subsets 
of remuneration arrangements (such as 
fees or other forms of compensation paid 
to or retained by the pharmacy benefit 
manager or affiliate of such pharmacy ben-
efit manager), as determined appropriate 
by the Secretary, between pharmacy ben-
efit managers or affiliates of such phar-
macy benefit managers, as applicable, and 
other entities involved in the dispensing or 
utilization of covered part D drugs (includ-
ing PDP sponsors, manufacturers, phar-
macies, and other entities as determined 
appropriate by the Secretary) shall be sub-
ject to review by the Secretary, in con-
sultation with the Office of the Inspector 
General of the Department of Health and 
Human Services, as determined appro-
priate by the Secretary. The Secretary, in 
consultation with the Office of the Inspec-
tor General, shall review whether remu-
neration under such arrangements is con-
sistent with fair market value (as specified 
by the Secretary) through reviews and as-
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sessments of such remuneration, as deter-
mined appropriate. 
‘‘(v) DISGORGEMENT.—The pharmacy 
benefit manager shall disgorge any remu-
neration paid to such pharmacy benefit 
manager or an affiliate of such pharmacy 
benefit manager in violation of this sub-
paragraph to the PDP sponsor. 
‘‘(vi) ADDITIONAL REQUIREMENTS.— 
The pharmacy benefit manager shall— 
‘‘(I) enter into a written agree-
ment with any affiliate of such phar-
macy benefit manager, under which 
the affiliate shall identify and disgorge 
any remuneration described in clause 
(v) to the pharmacy benefit manager; 
and 
‘‘(II) attest, subject to any re-
quirements determined appropriate by 
the Secretary, that the pharmacy ben-
efit manager has entered into a writ-
ten agreement described in subclause 
(I) with any relevant affiliate of the 
pharmacy benefit manager. 
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‘‘(B) TRANSPARENCY REGARDING GUARAN-
TEES
AND
COST
PERFORMANCE
EVALUA-
TIONS.—The pharmacy benefit manager shall— 
‘‘(i) define, interpret, and apply, in a 
fully transparent and consistent manner 
for purposes of calculating or otherwise 
evaluating pharmacy benefit manager per-
formance against pricing guarantees or 
similar cost performance measurements re-
lated to rebates, discounts, price conces-
sions, or net costs, terms such as— 
‘‘(I) ‘generic drug’, in a manner 
consistent with the definition of the 
term under section 423.4 of title 42, 
Code of Federal Regulations, or a suc-
cessor regulation; 
‘‘(II) ‘brand name drug’, in a 
manner consistent with the definition 
of the term under section 423.4 of 
title 42, Code of Federal Regulations, 
or a successor regulation; 
‘‘(III) ‘specialty drug’; 
‘‘(IV) ‘rebate’; and 
‘‘(V) ‘discount’; 
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‘‘(ii) identify any drugs, claims, or 
price concessions excluded from any pric-
ing guarantee or other cost performance 
measure in a clear and consistent manner; 
and 
‘‘(iii) where a pricing guarantee or 
other cost performance measure is based 
on a pricing benchmark other than the 
wholesale acquisition cost (as defined in 
section 1847A(c)(6)(B)) of a drug, cal-
culate and provide a wholesale acquisition 
cost-based equivalent to the pricing guar-
antee or other cost performance measure. 
‘‘(C) PROVISION OF INFORMATION.— 
‘‘(i) IN
GENERAL.—Not later than 
July 1 of each year, beginning in 2028, the 
pharmacy benefit manager shall submit to 
the PDP sponsor, and to the Secretary, a 
report, in accordance with this subpara-
graph, and shall make such report avail-
able to such sponsor at no cost to such 
sponsor in a format specified by the Sec-
retary under paragraph (5). Each such re-
port shall include, with respect to such 
PDP sponsor and each plan offered by 
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such sponsor, the following information 
with respect to the previous plan year: 
‘‘(I) A list of all drugs covered by 
the plan that were dispensed includ-
ing, with respect to each such drug— 
‘‘(aa) the brand name, ge-
neric or non-proprietary name, 
and National Drug Code; 
‘‘(bb) the number of plan 
enrollees for whom the drug was 
dispensed, the total number of 
prescription claims for the drug 
(including original prescriptions 
and refills, counted as separate 
claims), and the total number of 
dosage units of the drug dis-
pensed; 
‘‘(cc) the number of pre-
scription claims described in item 
(bb) by each type of dispensing 
channel through which the drug 
was dispensed, including retail, 
mail order, specialty pharmacy, 
long term care pharmacy, home 
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infusion pharmacy, or other types 
of pharmacies or providers; 
‘‘(dd) the average wholesale 
acquisition cost, listed as cost per 
day’s supply, cost per dosage 
unit, and cost per typical course 
of treatment (as applicable); 
‘‘(ee) the average wholesale 
price for the drug, listed as price 
per day’s supply, price per dos-
age unit, and price per typical 
course of treatment (as applica-
ble); 
‘‘(ff) the total out-of-pocket 
spending by plan enrollees on 
such drug after application of 
any benefits under the plan, in-
cluding plan enrollee spending 
through copayments, coinsurance, 
and deductibles; 
‘‘(gg) total rebates paid by 
the manufacturer on the drug as 
reported under the Detailed DIR 
Report (or any successor report) 
submitted by such sponsor to the 
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Centers for Medicare & Medicaid 
Services; 
‘‘(hh) all other direct or in-
direct remuneration on the drug 
as reported under the Detailed 
DIR Report (or any successor re-
port) submitted by such sponsor 
to the Centers for Medicare & 
Medicaid Services; 
‘‘(ii) the average pharmacy 
reimbursement amount paid by 
the plan for the drug in the ag-
gregate and disaggregated by dis-
pensing channel identified in item 
(cc); 
‘‘(jj) the average National 
Average Drug Acquisition Cost 
(NADAC); and 
‘‘(kk) total manufacturer-de-
rived revenue, inclusive of bona 
fide service fees, attributable to 
the drug and retained by the 
pharmacy benefit manager and 
any affiliate of such pharmacy 
benefit manager. 
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‘‘(II) In the case of a pharmacy 
benefit manager that has an affiliate 
that is a retail, mail order, or spe-
cialty pharmacy, with respect to drugs 
covered by such plan that were dis-
pensed, the following information: 
‘‘(aa) The percentage of 
total prescriptions that were dis-
pensed by pharmacies that are an 
affiliate of the pharmacy benefit 
manager for each drug. 
‘‘(bb) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
ees, per dosage unit, per course 
of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are not an affiliate of the 
pharmacy benefit manager and 
that are included in the phar-
macy network of such plan. 
‘‘(cc) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
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ees, per dosage unit, per course 
of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are an affiliate of the phar-
macy benefit manager and that 
are included in the pharmacy 
network of such plan. 
‘‘(dd) The lowest total com-
bined cost paid by the plan and 
plan enrollees, per dosage unit, 
per course of treatment, per 30- 
day supply, and per 90-day sup-
ply, for each drug that is avail-
able from any pharmacy included 
in the pharmacy network of such 
plan. 
‘‘(ee) The difference between 
the average acquisition cost of 
the affiliate, such as a pharmacy 
or other entity that acquires pre-
scription drugs, that initially ac-
quires the drug and the amount 
reported under subclause (I)(jj) 
for each drug. 
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‘‘(ff) A list inclusive of the 
brand name, generic or non-pro-
prietary 
name, 
and 
National 
Drug Code of covered part D 
drugs subject to an agreement 
with a covered entity under sec-
tion 340B of the Public Health 
Service Act for which the phar-
macy benefit manager or an affil-
iate of the pharmacy benefit 
manager had a contract or other 
arrangement with such a covered 
entity in the service area of such 
plan. 
‘‘(III) Where a drug approved 
under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (re-
ferred to in this subclause as the ‘list-
ed drug’) is covered by the plan, the 
following information: 
‘‘(aa) A list of currently 
marketed generic drugs approved 
under section 505(j) of the Fed-
eral Food, Drug, and Cosmetic 
Act pursuant to an application 
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that references such listed drug 
that are not covered by the plan, 
are covered on the same for-
mulary tier or a formulary tier 
typically associated with higher 
cost-sharing than the listed drug, 
or are subject to utilization man-
agement that the listed drug is 
not subject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the listed drug. 
‘‘(cc) Where a generic drug 
listed under item (aa) is on a for-
mulary tier typically associated 
with higher cost-sharing than the 
listed drug, the estimated aver-
age cost-sharing that a bene-
ficiary would have paid for a 30- 
day supply of each of the generic 
drugs described in item (aa), had 
the plan provided coverage for 
such drugs on the same for-
mulary tier as the listed drug. 
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‘‘(dd) A written justification 
for providing more favorable cov-
erage of the listed drug than the 
generic drugs described in item 
(aa). 
‘‘(ee) The number of cur-
rently marketed generic drugs 
approved under section 505(j) of 
the Federal Food, Drug, and 
Cosmetic Act pursuant to an ap-
plication that references such 
listed drug. 
‘‘(IV) Where a reference product 
(as defined in section 351(i) of the 
Public Health Service Act) is covered 
by the plan, the following information: 
‘‘(aa) A list of currently 
marketed 
biosimilar 
biological 
products licensed under section 
351(k) of the Public Health 
Service Act pursuant to an appli-
cation that refers to such ref-
erence product that are not cov-
ered by the plan, are covered on 
the same formulary tier or a for-
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mulary tier typically associated 
with higher cost-sharing than the 
reference product, or are subject 
to utilization management that 
the reference product is not sub-
ject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the reference product. 
‘‘(cc) Where a biosimilar bi-
ological product listed under item 
(aa) is on a formulary tier typi-
cally associated with higher cost- 
sharing than the reference prod-
uct, the estimated average cost- 
sharing that a beneficiary would 
have paid for a 30-day supply of 
each of the biosimilar biological 
products described in item (aa), 
had the plan provided coverage 
for such products on the same 
formulary tier as the reference 
product. 
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‘‘(dd) A written justification 
for providing more favorable cov-
erage of the reference product 
than the biosimilar biological 
product described in item (aa). 
‘‘(ee) The number of cur-
rently marketed biosimilar bio-
logical products licensed under 
section 351(k) of the Public 
Health Service Act, pursuant to 
an application that refers to such 
reference product. 
‘‘(V) Total gross spending on 
covered part D drugs by the plan, not 
net of rebates, fees, discounts, or 
other direct or indirect remuneration. 
‘‘(VI) The total amount retained 
by the pharmacy benefit manager or 
an affiliate of such pharmacy benefit 
manager in revenue related to utiliza-
tion of covered part D drugs under 
that plan, inclusive of bona fide serv-
ice fees. 
‘‘(VII) The total spending on cov-
ered part D drugs net of rebates, fees, 
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discounts, or other direct and indirect 
remuneration by the plan. 
‘‘(VIII) An explanation of any 
benefit design parameters under such 
plan that encourage plan enrollees to 
fill prescriptions at pharmacies that 
are an affiliate of such pharmacy ben-
efit manager, such as mail and spe-
cialty home delivery programs, and re-
tail and mail auto-refill programs. 
‘‘(IX) The following information: 
‘‘(aa) A list of all brokers, 
consultants, advisors, and audi-
tors that receive compensation 
from the pharmacy benefit man-
ager or an affiliate of such phar-
macy benefit manager for refer-
rals, 
consulting, 
auditing, 
or 
other services offered to PDP 
sponsors related to pharmacy 
benefit management services. 
‘‘(bb) The amount of com-
pensation provided by such phar-
macy benefit manager or affiliate 
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to each such broker, consultant, 
advisor, and auditor. 
‘‘(cc) The methodology for 
calculating the amount of com-
pensation provided by such phar-
macy benefit manager or affil-
iate, for each such broker, con-
sultant, advisor, and auditor. 
‘‘(X) A list of all affiliates of the 
pharmacy benefit manager. 
‘‘(XI) A summary document sub-
mitted in a standardized template de-
veloped by the Secretary that includes 
such information described in sub-
clauses (I) through (X). 
‘‘(ii) WRITTEN EXPLANATION OF CON-
TRACTS
OR
AGREEMENTS
WITH
DRUG 
MANUFACTURERS.— 
‘‘(I) IN
GENERAL.—The phar-
macy benefit manager shall, not later 
than 30 days after the finalization of 
any contract or agreement between 
such pharmacy benefit manager or an 
affiliate of such pharmacy benefit 
manager and a drug manufacturer (or 
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subsidiary, agent, or entity affiliated 
with such drug manufacturer) that 
makes rebates, discounts, payments, 
or other financial incentives related to 
one or more covered part D drugs or 
other prescription drugs, as applica-
ble, of the manufacturer directly or 
indirectly contingent upon coverage, 
formulary placement, or utilization 
management conditions on any other 
covered part D drugs or other pre-
scription drugs, as applicable, submit 
to the PDP sponsor a written expla-
nation of such contract or agreement. 
‘‘(II) REQUIREMENTS.—A writ-
ten explanation under subclause (I) 
shall— 
‘‘(aa) include the manufac-
turer subject to the contract or 
agreement, all covered part D 
drugs 
and 
other 
prescription 
drugs, as applicable, subject to 
the contract or agreement and 
the manufacturers of such drugs, 
and a high-level description of 
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the terms of such contract or 
agreement and how such terms 
apply to such drugs; and 
‘‘(bb) be certified by the 
Chief Executive Officer, Chief Fi-
nancial Officer, or General Coun-
sel of such pharmacy benefit 
manager, or affiliate of such 
pharmacy benefit manager, as 
applicable, or an individual dele-
gated with the authority to sign 
on behalf of one of these officers, 
who reports directly to the offi-
cer. 
‘‘(III) DEFINITION
OF
OTHER 
PRESCRIPTION DRUGS.—For purposes 
of this clause, the term ‘other pre-
scription drugs’ means prescription 
drugs covered as supplemental bene-
fits under this part or prescription 
drugs paid outside of this part. 
‘‘(D) AUDIT RIGHTS.— 
‘‘(i) IN GENERAL.—Not less than once 
a year, at the request of the PDP sponsor, 
the pharmacy benefit manager shall allow 
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for an audit of the pharmacy benefit man-
ager to ensure compliance with all terms 
and conditions under the written agree-
ment described in this paragraph and the 
accuracy of information reported under 
subparagraph (C). 
‘‘(ii) AUDITOR.—The PDP sponsor 
shall have the right to select an auditor. 
The pharmacy benefit manager shall not 
impose any limitations on the selection of 
such auditor. 
‘‘(iii) PROVISION OF INFORMATION.— 
The pharmacy benefit manager shall make 
available to such auditor all records, data, 
contracts, and other information necessary 
to confirm the accuracy of information 
provided under subparagraph (C), subject 
to reasonable restrictions on how such in-
formation must be reported to prevent re-
disclosure of such information. 
‘‘(iv) TIMING.—The pharmacy benefit 
manager must provide information under 
clause (iii) and other information, data, 
and records relevant to the audit to such 
auditor within 6 months of the initiation of 
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the audit and respond to requests for addi-
tional information from such auditor with-
in 30 days after the request for additional 
information. 
‘‘(v) INFORMATION
FROM
AFFILI-
ATES.—The pharmacy benefit manager 
shall be responsible for providing to such 
auditor information required to be reported 
under subparagraph (C) or under clause 
(iii) of this subparagraph that is owned or 
held by an affiliate of such pharmacy ben-
efit manager. 
‘‘(2) ENFORCEMENT.— 
‘‘(A) IN
GENERAL.—Each PDP sponsor 
shall— 
‘‘(i) disgorge to the Secretary any 
amounts disgorged to the PDP sponsor by 
a pharmacy benefit manager under para-
graph (1)(A)(v); 
‘‘(ii) require, in a written agreement 
with any pharmacy benefit manager acting 
on behalf of such sponsor or affiliate of 
such pharmacy benefit manager, that such 
pharmacy benefit manager or affiliate re-
imburse the PDP sponsor for any civil 
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money penalty imposed on the PDP spon-
sor as a result of the failure of the phar-
macy benefit manager or affiliate to meet 
the requirements of paragraph (1) that are 
applicable to the pharmacy benefit man-
ager or affiliate under the agreement; and 
‘‘(iii) require, in a written agreement 
with any such pharmacy benefit manager 
acting on behalf of such sponsor or affil-
iate of such pharmacy benefit manager, 
that such pharmacy benefit manager or af-
filiate be subject to punitive remedies for 
breach of contract for failure to comply 
with the requirements applicable under 
paragraph (1). 
‘‘(B) REPORTING
OF
ALLEGED
VIOLA-
TIONS.—The Secretary shall make available and 
maintain a mechanism for manufacturers, PDP 
sponsors, pharmacies, and other entities that 
have contractual relationships with pharmacy 
benefit managers or affiliates of such pharmacy 
benefit managers to report, on a confidential 
basis, alleged violations of paragraph (1)(A) or 
subparagraph (C). 
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‘‘(C) ANTI-RETALIATION AND ANTI-COER-
CION.—Consistent with applicable Federal or 
State law, a PDP sponsor shall not— 
‘‘(i) retaliate against an individual or 
entity for reporting an alleged violation 
under subparagraph (B); or 
‘‘(ii) coerce, intimidate, threaten, or 
interfere with the ability of an individual 
or entity to report any such alleged viola-
tions. 
‘‘(3) CERTIFICATION OF COMPLIANCE.— 
‘‘(A) IN
GENERAL.—Each PDP sponsor 
shall furnish to the Secretary (at a time and in 
a manner specified by the Secretary) an annual 
certification of compliance with this subsection, 
as well as such information as the Secretary de-
termines necessary to carry out this subsection. 
‘‘(B) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may 
implement this paragraph by program instruc-
tion or otherwise. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed as— 
‘‘(A) prohibiting flat dispensing fees or re-
imbursement or payment for ingredient costs 
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(including customary, industry-standard dis-
counts directly related to drug acquisition that 
are retained by pharmacies or wholesalers) to 
entities that acquire or dispense prescription 
drugs; or 
‘‘(B) modifying regulatory requirements or 
sub-regulatory program instruction or guidance 
related to pharmacy payment, reimbursement, 
or dispensing fees. 
‘‘(5) STANDARD FORMATS.— 
‘‘(A) IN GENERAL.—Not later than June 
1, 2027, the Secretary shall specify standard, 
machine-readable formats for pharmacy benefit 
managers to submit annual reports required 
under paragraph (1)(C)(i). 
‘‘(B) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may 
implement this paragraph by program instruc-
tion or otherwise. 
‘‘(6) CONFIDENTIALITY.— 
‘‘(A) IN GENERAL.—Information disclosed 
by a pharmacy benefit manager, an affiliate of 
a pharmacy benefit manager, a PDP sponsor, 
or a pharmacy under this subsection that is not 
otherwise publicly available or available for pur-
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chase shall not be disclosed by the Secretary or 
a PDP sponsor receiving the information, ex-
cept that the Secretary may disclose the infor-
mation for the following purposes: 
‘‘(i) As the Secretary determines nec-
essary to carry out this part. 
‘‘(ii) To permit the Comptroller Gen-
eral to review the information provided. 
‘‘(iii) To permit the Director of the 
Congressional Budget Office to review the 
information provided. 
‘‘(iv) To permit the Executive Direc-
tor of the Medicare Payment Advisory 
Commission to review the information pro-
vided. 
‘‘(v) To the Attorney General for the 
purposes of conducting oversight and en-
forcement under this title. 
‘‘(vi) To the Inspector General of the 
Department of Health and Human Serv-
ices in accordance with its authorities 
under the Inspector General Act of 1978 
(section 406 of title 5, United States 
Code), and other applicable statutes. 
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‘‘(B) RESTRICTION ON USE OF INFORMA-
TION.—The Secretary, the Comptroller General, 
the Director of the Congressional Budget Of-
fice, and the Executive Director of the Medicare 
Payment Advisory Commission shall not report 
on or disclose information disclosed pursuant to 
subparagraph (A) to the public in a manner 
that would identify— 
‘‘(i) a specific pharmacy benefit man-
ager, affiliate, pharmacy, manufacturer, 
wholesaler, PDP sponsor, or plan; or 
‘‘(ii) contract prices, rebates, dis-
counts, or other remuneration for specific 
drugs in a manner that may allow the 
identification of specific contracting parties 
or of such specific drugs. 
‘‘(7) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) AFFILIATE.—The term ‘affiliate’ 
means, with respect to any pharmacy benefit 
manager or PDP sponsor, any entity that, di-
rectly or indirectly— 
‘‘(i) owns or is owned by, controls or 
is controlled by, or is otherwise related in 
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any ownership structure to such pharmacy 
benefit manager or PDP sponsor; or 
‘‘(ii) acts as a contractor, principal, or 
agent to such pharmacy benefit manager 
or PDP sponsor, insofar as such con-
tractor, principal, or agent performs any of 
the functions described under subpara-
graph (C). 
‘‘(B) BONA FIDE SERVICE FEE.—The term 
‘bona fide service fee’ means a fee that is reflec-
tive of the fair market value (as specified by the 
Secretary, through notice and comment rule-
making) for a bona fide, itemized service actu-
ally performed on behalf of an entity, that the 
entity would otherwise perform (or contract for) 
in the absence of the service arrangement and 
that is not passed on in whole or in part to a 
client or customer, whether or not the entity 
takes title to the drug. Such fee must be a flat 
dollar amount and shall not be directly or indi-
rectly based on, or contingent upon— 
‘‘(i) drug price, such as wholesale ac-
quisition cost or drug benchmark price 
(such as average wholesale price); 
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‘‘(ii) the amount of discounts, rebates, 
fees, or other direct or indirect remunera-
tion with respect to covered part D drugs 
dispensed to enrollees in a prescription 
drug plan, except as permitted pursuant to 
paragraph (1)(A)(ii); 
‘‘(iii) coverage or formulary placement 
decisions or the volume or value of any re-
ferrals or business generated between the 
parties to the arrangement; or 
‘‘(iv) any other amounts or meth-
odologies prohibited by the Secretary. 
‘‘(C) PHARMACY BENEFIT MANAGER.—The 
term ‘pharmacy benefit manager’ means any 
person or entity that, either directly or through 
an intermediary, acts as a price negotiator or 
group purchaser on behalf of a PDP sponsor or 
prescription drug plan, or manages the pre-
scription drug benefits provided by such spon-
sor or plan, including the processing and pay-
ment of claims for prescription drugs, the per-
formance of drug utilization review, the proc-
essing of drug prior authorization requests, the 
adjudication of appeals or grievances related to 
the prescription drug benefit, contracting with 
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network pharmacies, controlling the cost of cov-
ered part D drugs, or the provision of related 
services. Such term includes any person or enti-
ty that carries out one or more of the activities 
described in the preceding sentence, irrespective 
of whether such person or entity calls itself a 
‘pharmacy benefit manager’.’’. 
(2) MA–PD PLANS.—Section 1857(f)(3) of the 
Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(F) REQUIREMENTS RELATING TO PHAR-
MACY BENEFIT MANAGERS.—For plan years be-
ginning on or after January 1, 2028, section 
1860D–12(h).’’. 
(3) NONAPPLICATION OF PAPERWORK REDUC-
TION ACT.—Chapter 35 of title 44, United States 
Code, shall not apply to the implementation of this 
subsection. 
(4) FUNDING.— 
(A) SECRETARY.—In addition to amounts 
otherwise available, there is appropriated to the 
Centers for Medicare & Medicaid Services Pro-
gram Management Account, out of any money 
in the Treasury not otherwise appropriated, 
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$113,000,000 for fiscal year 2025, to remain 
available until expended, to carry out this sub-
section. 
(B) OIG.—In addition to amounts other-
wise available, there is appropriated to the In-
spector General of the Department of Health 
and Human Services, out of any money in the 
Treasury 
not 
otherwise 
appropriated, 
$20,000,000 for fiscal year 2025, to remain 
available until expended, to carry out this sub-
section. 
(b) GAO STUDY AND REPORT ON PRICE-RELATED 
COMPENSATION ACROSS THE SUPPLY CHAIN.— 
(1) STUDY.—The Comptroller General of the 
United States (in this subsection referred to as the 
‘‘Comptroller General’’) shall conduct a study de-
scribing the use of compensation and payment struc-
tures related to a prescription drug’s price within 
the retail prescription drug supply chain in part D 
of title XVIII of the Social Security Act (42 U.S.C. 
1395w–101 et seq.). Such study shall summarize in-
formation from Federal agencies and industry ex-
perts, to the extent available, with respect to the fol-
lowing: 
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(A) The type, magnitude, other features 
(such as the pricing benchmarks used), and 
prevalence of compensation and payment struc-
tures related to a prescription drug’s price, 
such as calculating fee amounts as a percentage 
of a prescription drug’s price, between inter-
mediaries in the prescription drug supply chain, 
including— 
(i) pharmacy benefit managers; 
(ii) PDP sponsors offering prescrip-
tion drug plans and Medicare Advantage 
organizations offering MA–PD plans; 
(iii) drug wholesalers; 
(iv) pharmacies; 
(v) manufacturers; 
(vi) pharmacy services administrative 
organizations; 
(vii) brokers, auditors, consultants, 
and other entities that— 
(I) advise PDP sponsors offering 
prescription drug plans and Medicare 
Advantage organizations offering MA– 
PD plans regarding pharmacy bene-
fits; or 
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(II) review PDP sponsor and 
Medicare Advantage organization con-
tracts with pharmacy benefit man-
agers; and 
(viii) other service providers that con-
tract with any of the entities described in 
clauses (i) through (vii) that may use 
price-related compensation and payment 
structures, such as rebate aggregators (or 
other entities that negotiate or process 
price concessions on behalf of pharmacy 
benefit managers, plan sponsors, or phar-
macies). 
(B) The primary business models and com-
pensation structures for each category of inter-
mediary described in subparagraph (A). 
(C) Variation in price-related compensation 
structures between affiliated entities (such as 
entities with common ownership, either full or 
partial, and subsidiary relationships) and unaf-
filiated entities. 
(D) Potential conflicts of interest among 
contracting entities related to the use of pre-
scription drug price-related compensation struc-
tures, such as the potential for fees or other 
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payments set as a percentage of a prescription 
drug’s price to advantage formulary selection, 
distribution, or purchasing of prescription drugs 
with higher prices. 
(E) Notable differences, if any, in the use 
and level of price-based compensation struc-
tures over time and between different market 
segments, such as under part D of title XVIII 
of the Social Security Act (42 U.S.C. 1395w– 
101 et seq.) and the Medicaid program under 
title XIX of such Act (42 U.S.C. 1396 et seq.). 
(F) The effects of drug price-related com-
pensation structures and alternative compensa-
tion structures on Federal health care programs 
and program beneficiaries, including with re-
spect to cost-sharing, premiums, Federal out-
lays, biosimilar and generic drug adoption and 
utilization, drug shortage risks, and the poten-
tial for fees set as a percentage of a drug’s 
price to advantage the formulary selection, dis-
tribution, or purchasing of drugs with higher 
prices. 
(G) Other issues determined to be relevant 
and appropriate by the Comptroller General. 
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(2) REPORT.—Not later than 2 years after the 
date of enactment of this section, the Comptroller 
General shall submit to Congress a report containing 
the results of the study conducted under paragraph 
(1), together with recommendations for such legisla-
tion and administrative action as the Comptroller 
General determines appropriate. 
(c) MEDPAC REPORTS
ON AGREEMENTS WITH 
PHARMACY BENEFIT MANAGERS WITH RESPECT TO PRE-
SCRIPTION DRUG PLANS AND MA–PD PLANS.— 
(1) IN GENERAL.—The Medicare Payment Ad-
visory Commission shall submit to Congress the fol-
lowing reports: 
(A) INITIAL REPORT.—Not later than the 
first March 15 occurring after the date that is 
2 years after the date on which the Secretary 
makes the data available to the Commission, a 
report regarding agreements with pharmacy 
benefit managers with respect to prescription 
drug plans and MA–PD plans. Such report 
shall include, to the extent practicable— 
(i) a description of trends and pat-
terns, including relevant averages, totals, 
and other figures for the types of informa-
tion submitted; 
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(ii) an analysis of any differences in 
agreements and their effects on plan en-
rollee out-of-pocket spending and average 
pharmacy reimbursement, and other im-
pacts; and 
(iii) any recommendations the Com-
mission determines appropriate. 
(B) FINAL
REPORT.—Not later than 2 
years after the date on which the Commission 
submits the initial report under subparagraph 
(A), a report describing any changes with re-
spect to the information described in subpara-
graph (A) over time, together with any rec-
ommendations the Commission determines ap-
propriate. 
(2) FUNDING.—In addition to amounts other-
wise available, there is appropriated to the Medicare 
Payment Advisory Commission, out of any money in 
the 
Treasury 
not 
otherwise 
appropriated, 
$1,000,000 for fiscal year 2025, to remain available 
until expended, to carry out this subsection. 
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356 
SEC. 228. REQUIRING A SEPARATE IDENTIFICATION NUM-
BER AND AN ATTESTATION FOR EACH OFF- 
CAMPUS OUTPATIENT DEPARTMENT OF A 
PROVIDER. 
(a) IN GENERAL.—Section 1833(t) of the Social Se-
curity Act (42 U.S.C. 1395l(t)) is amended by adding at 
the end the following new paragraph: 
‘‘(23) USE OF UNIQUE HEALTH IDENTIFIERS; 
ATTESTATION.— 
‘‘(A) IN GENERAL.—No payment may be 
made under this subsection (or under an appli-
cable payment system pursuant to paragraph 
(21)) for items and services furnished on or 
after January 1, 2026, by an off-campus out-
patient department of a provider (as defined in 
subparagraph (C)) unless— 
‘‘(i) such department has obtained, 
and such items and services are billed 
under, a standard unique health identifier 
for health care providers (as described in 
section 1173(b)) that is separate from 
such identifier for such provider; 
‘‘(ii) such provider has submitted to 
the Secretary, during the 2-year period 
ending on the date such items and services 
are so furnished, an initial provider-based 
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357 
status attestation that such department is 
compliant with the requirements described 
in section 413.65 of title 42, Code of Fed-
eral Regulations (or a successor regula-
tion); and 
‘‘(iii) after such provider has sub-
mitted an attestation under clause (ii), 
such provider has submitted a subsequent 
attestation within the timeframe specified 
by the Secretary. 
‘‘(B) PROCESS FOR SUBMISSION AND RE-
VIEW.—Not later than 1 year after the date of 
enactment of this paragraph, the Secretary 
shall, through notice and comment rulemaking, 
establish a process for each provider with an 
off-campus outpatient department of a provider 
to submit an initial and subsequent attestation 
pursuant to clauses (ii) and (iii), respectively, of 
subparagraph (A), and for the Secretary to re-
view each such attestation and determine, 
through site visits, remote audits, or other 
means (as determined appropriate by the Sec-
retary), whether such department is compliant 
with the requirements described in such sub-
paragraph. 
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‘‘(C) OFF-CAMPUS
OUTPATIENT
DEPART-
MENT OF A PROVIDER DEFINED.—For purposes 
of this paragraph, the term ‘off-campus out-
patient department of a provider’ means a de-
partment of a provider (as defined in section 
413.65 of title 42, Code of Federal Regulations, 
or any successor regulation) that is not lo-
cated— 
‘‘(i) on the campus (as defined in such 
section) of such provider; or 
‘‘(ii) within the distance (described in 
such definition of campus) from a remote 
location of a hospital facility (as defined in 
such section).’’. 
(b) HHS OIG ANALYSIS.—Not later than January 
1, 2030, the Inspector General of the Department of 
Health and Human Services shall submit to Congress— 
(1) an analysis of the process established by the 
Secretary of Health and Human Services to conduct 
the reviews and determinations described in section 
1833(t)(23)(B) of the Social Security Act, as added 
by subsection (a) of this section; and 
(2) recommendations based on such analysis, as 
the Inspector General determines appropriate. 
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359 
SEC. 229. MEDICARE SEQUESTRATION. 
Section 251A(6) of the Balanced Budget and Emer-
gency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) is 
amended— 
(1) in subparagraph (D), by striking ‘‘such 
that,’’ and all that follows and inserting ‘‘such that 
the payment reduction shall be 2.0 percent.’’; and 
(2) by adding at the end the following: 
‘‘(F) On the date on which the President sub-
mits the budget under section 1105 of title 31, 
United States Code, for fiscal year 2033, the Presi-
dent shall order a sequestration of payments for the 
Medicare programs specified in section 256(d), effec-
tive upon issuance, such that, notwithstanding the 2 
percent limit specified in subparagraph (A) for such 
payments— 
‘‘(i) with respect to the first 2 months in 
which such order is effective for such fiscal 
year, the payment reduction shall be 2.0 per-
cent; and 
‘‘(ii) with respect to the last 10 months in 
which such order is effective for such fiscal 
year, the payment reduction shall be 0 per-
cent.’’. 
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360 
TITLE III—OTHER MATTERS 
SEC. 301. SEXUAL RISK AVOIDANCE EDUCATION EXTEN-
SION. 
Section 510 of the Social Security Act (42 U.S.C. 
710) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1)— 
(i) by striking ‘‘and for the period’’ 
and inserting ‘‘for the period’’; 
(ii) by striking ‘‘March 31, 2025’’ and 
inserting ‘‘September 30, 2025’’; 
(iii) by inserting ‘‘and for the period 
beginning on October 1, 2025, and ending 
on December 31, 2025,’’ before ‘‘allot to 
each State’’; and 
(iv) by striking ‘‘for fiscal year 2024 
or 2025’’ and inserting ‘‘for fiscal year 
2024, 2025, or 2026’’; and 
(B) in paragraph (2), by striking ‘‘or 
2025’’ each place it appears and inserting ‘‘, 
2025, or 2026’’; and 
(2) in subsection (f)(1)— 
(A) by striking ‘‘and for the period’’ and 
inserting ‘‘for the period’’; 
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361 
(B) by striking ‘‘March 31, 2025’’ and in-
serting ‘‘September 30, 2025’’; and 
(C) by inserting ‘‘, and for the period be-
ginning on October 1, 2025, and ending on De-
cember 31, 2025, an amount equal to the pro 
rata portion of the amount appropriated for the 
corresponding period for fiscal year 2025’’ after 
‘‘corresponding period for fiscal year 2024’’. 
SEC. 302. PERSONAL RESPONSIBILITY EDUCATION EXTEN-
SION. 
Section 513 of the Social Security Act (42 U.S.C. 
713) is amended— 
(1) in subsection (a)(1)— 
(A) in subparagraph (A), in the matter 
preceding clause (i)— 
(i) by striking ‘‘and for the period’’ 
and inserting ‘‘for the period’’; 
(ii) by striking ‘‘March 31, 2025’’ and 
inserting ‘‘September 30, 2025’’; and 
(iii) by inserting ‘‘and for the period 
beginning on October 1, 2025, and ending 
on December 31, 2025,’’ before ‘‘the Sec-
retary shall allot’’; and 
(B) in subparagraph (B)(i)— 
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(i) by striking ‘‘and for the period’’ 
and inserting ‘‘for the period’’; 
(ii) by striking ‘‘March 31, 2025’’ and 
inserting ‘‘September 30, 2025’’; and 
(iii) by inserting ‘‘, and for the period 
beginning on October 1, 2025, and ending 
on December 31, 2025’’ before the period; 
(2) in subsection (c)(3), by striking ‘‘fiscal year 
2024 or 2025’’ and inserting ‘‘fiscal year 2024, 
2025, or 2026’’; and 
(3) in subsection (f)— 
(A) by striking ‘‘and for the period’’ and 
inserting ‘‘for the period’’; 
(B) by striking ‘‘March 31, 2025’’ and in-
serting ‘‘September 30, 2025’’; and 
(C) by inserting ‘‘, and for the period be-
ginning on October 1, 2025, and ending on De-
cember 31, 2025, an amount equal to the pro 
rata portion of the amount appropriated for the 
corresponding period for fiscal year 2025’’ after 
‘‘corresponding period for fiscal year 2024’’. 
SEC. 303. EXTENSION OF FUNDING FOR FAMILY-TO-FAMILY 
HEALTH INFORMATION CENTERS. 
Section 501(c)(1)(A)(viii) of the Social Security Act 
(42 U.S.C. 701(c)(1)(A)(viii)) is amended— 
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363 
(1) by striking ‘‘$3,000,000’’ and inserting 
‘‘$7,500,000’’; and 
(2) by striking ‘‘for the portion of fiscal year 
2025 before April 1, 2025’’ and inserting ‘‘for the 
period beginning on October 1, 2024, and ending on 
December 31, 2025’’. 
TITLE IV—PUBLIC HEALTH 
EXTENDERS 
Subtitle A—Extensions 
SEC. 401. EXTENSION FOR COMMUNITY HEALTH CENTERS, 
NATIONAL HEALTH SERVICE CORPS, AND 
TEACHING HEALTH CENTERS THAT OPERATE 
GME PROGRAMS. 
(a) EXTENSION
FOR COMMUNITY HEALTH CEN-
TERS.—Section 10503(b)(1) of the Patient Protection and 
Affordable Care Act (42 U.S.C. 254b–2(b)(1)) is amend-
ed— 
(1) in subparagraph (H), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (I), by striking the period 
at the end and inserting a semicolon; and 
(3) by adding at the end the following: 
‘‘(J) $2,315,342,466 for the period begin-
ning on April 1, 2025, and ending on Sep-
tember 30, 2025; and 
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‘‘(F) $112,849,315 for the period begin-
ning on April 1, 2025, and ending on Sep-
tember 30, 2025; 
‘‘(G) $225,000,000 for fiscal year 2026; 
‘‘(H) $250,000,000 for fiscal year 2027; 
‘‘(I) $275,000,000 for fiscal year 2028; 
and 
‘‘(J) $300,000,000 for fiscal year 2029.’’. 
(d) APPLICATION OF PROVISIONS.—Amounts appro-
priated pursuant to the amendments made by this section 
shall be subject to the requirements contained in Public 
Law 117–328 for funds for programs authorized under 
sections 330 through 340 of the Public Health Service Act 
(42 U.S.C. 254b et seq.). 
(e) CONFORMING AMENDMENT.—Section 3014(h)(4) 
of title 18, United States Code, is amended by striking 
‘‘and section 3101(d) of the Health Extensions and Other 
Matters Act, 2025’’ and inserting ‘‘section 3101(d) of the 
Health Extensions and Other Matters Act, 2025, and sec-
tion 401 of the Lower Costs for Everyday Americans Act’’. 
SEC. 402. EXTENSION OF SPECIAL DIABETES PROGRAMS. 
(a) EXTENSION OF SPECIAL DIABETES PROGRAMS 
FOR TYPE I DIABETES.—Section 330B(b)(2) of the Pub-
lic Health Service Act (42 U.S.C. 254c–2(b)(2)) is amend-
ed— 
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(1) in subparagraph (E), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (F), by striking the period 
at the end and inserting a semicolon; and 
(3) by adding at the end the following: 
‘‘(G) $110,327,296 for the period begin-
ning on April 1, 2025, and ending on Sep-
tember 30, 2025, to remain available until ex-
pended; and 
‘‘(H) $200,000,000 for fiscal year 2026, to 
remain available until expended.’’. 
(b) EXTENDING FUNDING FOR SPECIAL DIABETES 
PROGRAMS
FOR INDIANS.—Section 330C(c)(2) of the 
Public Health Service Act (42 U.S.C. 254c–3(c)(2)) is 
amended— 
(1) in subparagraph (E), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (F), by striking the period 
at the end and inserting a semicolon; and 
(3) by adding at the end the following: 
‘‘(G) $110,327,296 for the period begin-
ning on April 1, 2025, and ending on Sep-
tember 30, 2025, to remain available until ex-
pended; and 
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‘‘(H) $200,000,000 for fiscal year 2026, to 
remain available until expended.’’. 
Subtitle B—World Trade Center 
Health Program 
SEC. 411. 9/11 RESPONDER AND SURVIVOR HEALTH FUND-
ING CORRECTIONS. 
(a) IN GENERAL.—Section 3351(a)(2)(A) of the 
Public 
Health 
Service 
Act 
(42 
U.S.C. 
300mm– 
61(a)(2)(A)) is amended— 
(1) in clause (x), by striking ‘‘; and’’ and insert-
ing a semicolon; 
(2) by redesignating clause (xi) as clause (xii); 
and 
(3) by inserting after clause (x), the following: 
‘‘(xi) for each of fiscal years 2026 
through 2040— 
‘‘(I) 
the 
amount 
determined 
under this subparagraph for the pre-
vious fiscal year multiplied by 1.05; 
multiplied by 
‘‘(II) the ratio of— 
‘‘(aa) the total number of 
individuals enrolled in the WTC 
Program on July 1 of such pre-
vious fiscal year; to 
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‘‘(bb) the total number of 
individuals so enrolled on July 1 
of the fiscal year prior to such 
previous fiscal year; and’’. 
(b) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sub-
section as the ‘‘Secretary’’) shall conduct an assess-
ment of anticipated budget authority and outlays of 
the World Trade Center Health Program (referred 
to in this subsection as the ‘‘Program’’) through the 
duration of the Program and submit a report sum-
marizing such assessment to— 
(A) the Speaker and minority leader of the 
House of Representatives; 
(B) the majority and minority leaders of 
the Senate; 
(C) the Committee on Health, Education, 
Labor, and Pensions and Committee on the 
Budget of the Senate; and 
(D) the Committee on Energy and Com-
merce and the Committee on the Budget of the 
House of Representatives. 
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(2) INCLUSIONS.—The report required under 
paragraph (1) shall include— 
(A) a projection of Program budgetary 
needs on a per-fiscal year basis through fiscal 
year 2090; 
(B) a review of Program modeling for each 
of fiscal years 2017 through the fiscal year 
prior to the fiscal year in which the report is 
issued to assess how anticipated budgetary 
needs compared to actual expenditures; 
(C) an assessment of the projected budget 
authority and expenditures of the Program 
through fiscal year 2090 by comparing— 
(i) such projected authority and ex-
penditures resulting from application of 
section 3351(a)(2)(A) of the Public Health 
Service 
Act 
(42 
U.S.C. 
300mm– 
61(a)(2)(A)), as amended by subsection 
(a); 
(ii) such projected authority and ex-
penditures that would result if such section 
were amended so that the formula under 
clause (xi) of such section, as amended by 
subsection (a), were to be extended 
through fiscal year 2090; and 
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(D) any recommendations of the Secretary 
to make changes to the formula under such sec-
tion 3351(a)(2)(A), as so amended, to fully off-
set anticipated Program expenditures through 
fiscal year 2090. 
(c) TECHNICAL AMENDMENTS.—Title XXXIII of the 
Public Health Service Act (42 U.S.C. 300mm et seq.) is 
amended— 
(1) in section 3352(d) (42 U.S.C. 300mm– 
62(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’; 
(2) in section 3353(d) (42 U.S.C. 300mm– 
63(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’; and 
(3) in section 3354(d) (42 U.S.C. 300mm– 
64(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’. 
TITLE V—SUPPORT ACT 
REAUTHORIZATION 
SEC. 501. SHORT TITLE. 
This title may be cited as the ‘‘SUPPORT for Pa-
tients and Communities Reauthorization Act of 2025’’. 
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Subtitle A—Prevention 
SEC. 511. PRENATAL AND POSTNATAL HEALTH. 
Section 317L(d) of the Public Health Service Act (42 
U.S.C. 247b–13(d)) is amended by striking ‘‘such sums 
as may be necessary for each of the fiscal years 2019 
through 2023’’ and inserting ‘‘$4,250,000 for each of fis-
cal years 2025 through 2029’’. 
SEC. 512. MONITORING AND EDUCATION REGARDING IN-
FECTIONS ASSOCIATED WITH ILLICIT DRUG 
USE AND OTHER RISK FACTORS. 
Section 317N(d) of the Public Health Service Act (42 
U.S.C. 247b–15(d)) is amended by striking ‘‘fiscal years 
2019 through 2023’’ and inserting ‘‘fiscal years 2025 
through 2029’’. 
SEC. 513. PREVENTING OVERDOSES OF CONTROLLED SUB-
STANCES. 
(a) IN GENERAL.—Section 392A of the Public 
Health Service Act (42 U.S.C. 280b–1) is amended— 
(1) in subsection (a)(2)— 
(A) in subparagraph (C), by inserting ‘‘and 
associated risks’’ before the period at the end; 
and 
(B) in subparagraph (D), by striking 
‘‘opioids’’ and inserting ‘‘substances causing 
overdose’’; and 
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(2) in subsection (b)(2)— 
(A) in subparagraph (B), by inserting ‘‘, 
and associated risk factors,’’ after ‘‘such 
overdoses’’; 
(B) in subparagraph (C), by striking ‘‘cod-
ing’’ and inserting ‘‘monitoring and identi-
fying’’; 
(C) in subparagraph (E)— 
(i) by inserting a comma after ‘‘public 
health laboratories’’; and 
(ii) by inserting ‘‘and other emerging 
substances related’’ after ‘‘analogues’’; and 
(D) in subparagraph (F), by inserting 
‘‘and associated risk factors’’ after ‘‘overdoses’’. 
(b) ADDITIONAL GRANTS.—Section 392A(a)(3) of 
the Public Health Service Act (42 U.S.C. 280b–1(a)(3)) 
is amended— 
(1) in the matter preceding subparagraph (A), 
by striking ‘‘and Indian Tribes—’’ and inserting 
‘‘and Indian Tribes for the following purposes:’’; 
(2) by amending subparagraph (A) to read as 
follows: 
‘‘(A) To carry out innovative projects for 
grantees to detect, identify, and rapidly respond 
to controlled substance misuse, abuse, and 
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overdoses, and associated risk factors, including 
changes in patterns of such controlled sub-
stance use. Such projects may include the use 
of innovative, evidence-based strategies for de-
tecting such patterns, such as wastewater sur-
veillance, if proven to support actionable pre-
vention strategies, in a manner consistent with 
applicable Federal and State privacy laws.’’; 
and 
(3) in subparagraph (B), by striking ‘‘for any’’ 
and inserting ‘‘For any’’. 
(c) AUTHORIZATION OF APPROPRIATIONS.—Section 
392A(e) of the Public Health Service Act (42 U.S.C. 
280b–1(e)) is amended by striking ‘‘$496,000,000 for 
each of fiscal years 2019 through 2023’’ and inserting 
‘‘$505,579,000 for each of fiscal years 2025 through 
2029’’. 
SEC. 514. SUPPORT FOR INDIVIDUALS AND FAMILIES IM-
PACTED BY FETAL ALCOHOL SPECTRUM DIS-
ORDER. 
(a) IN GENERAL.—Part O of title III of the Public 
Health Service Act (42 U.S.C. 280f et seq.) is amended 
to read as follows: 
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‘‘PART O—FETAL ALCOHOL SYNDROME 
PREVENTION AND SERVICES PROGRAM 
‘‘SEC. 399H. FETAL ALCOHOL SPECTRUM DISORDERS PRE-
VENTION, INTERVENTION, AND SERVICES DE-
LIVERY PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish or 
continue activities to support a comprehensive fetal alcohol 
spectrum disorders (referred to in this section as ‘FASD’) 
education, prevention, identification, intervention, and 
services delivery program, which may include— 
‘‘(1) an education and public awareness pro-
gram to support, conduct, and evaluate the effective-
ness of— 
‘‘(A) 
educational 
programs 
targeting 
health professions schools, social and other sup-
portive services, educators and counselors and 
other service providers in all phases of child-
hood development, and other relevant service 
providers, concerning the prevention, identifica-
tion, and provision of services for infants, chil-
dren, adolescents and adults with FASD; 
‘‘(B) strategies to educate school-age chil-
dren, including pregnant and high-risk youth, 
concerning FASD; 
‘‘(C) public and community awareness pro-
grams concerning FASD; and 
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‘‘(D) strategies to coordinate information 
and services across affected community agen-
cies, including agencies providing social services 
such as foster care, adoption, and social work, 
agencies providing health services, and agencies 
involved in education, vocational training and 
civil and criminal justice; 
‘‘(2) supporting and conducting research on 
FASD, as appropriate, including to— 
‘‘(A) develop appropriate medical diag-
nostic methods for identifying FASD; and 
‘‘(B) develop effective culturally and lin-
guistically appropriate evidence-based or evi-
dence-informed interventions and appropriate 
supports for preventing prenatal alcohol expo-
sure, which may co-occur with exposure to other 
substances; 
‘‘(3) building State and Tribal capacity for the 
identification, treatment, and support of individuals 
with FASD and their families, which may include— 
‘‘(A) utilizing and adapting existing Fed-
eral, State, or Tribal programs to include 
FASD identification and FASD-informed sup-
port; 
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‘‘(B) developing and expanding screening 
and diagnostic capacity for FASD; 
‘‘(C) developing, implementing, and evalu-
ating targeted FASD-informed intervention 
programs for FASD; 
‘‘(D) providing training with respect to 
FASD for professionals across relevant sectors; 
and 
‘‘(E) 
disseminating 
information 
about 
FASD and support services to affected individ-
uals and their families; and 
‘‘(4) an applied research program concerning 
intervention and prevention to support and conduct 
service demonstration projects, clinical studies and 
other research models providing advocacy, edu-
cational and vocational training, counseling, medical 
and mental health, and other supportive services, as 
well as models that integrate and coordinate such 
services, that are aimed at the unique challenges fac-
ing individuals with Fetal Alcohol Syndrome or 
Fetal Alcohol Effect and their families. 
‘‘(b) GRANTS AND TECHNICAL ASSISTANCE.— 
‘‘(1) IN GENERAL.—The Secretary may award 
grants, cooperative agreements and contracts and 
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provide technical assistance to eligible entities to 
carry out subsection (a). 
‘‘(2) ELIGIBLE ENTITIES.—To be eligible to re-
ceive a grant, or enter into a cooperative agreement 
or contract, under this section, an entity shall— 
‘‘(A) be a State, Indian Tribe or Tribal or-
ganization, local government, scientific or aca-
demic institution, or nonprofit organization; 
and 
‘‘(B) prepare and submit to the Secretary 
an application at such time, in such manner, 
and containing such information as the Sec-
retary may require, including a description of 
the activities that the entity intends to carry 
out using amounts received under this section. 
‘‘(3) ADDITIONAL
APPLICATION
CONTENTS.— 
The Secretary may require that an eligible entity in-
clude in the application submitted under paragraph 
(2)(B)— 
‘‘(A) a designation of an individual to 
serve as a FASD State or Tribal coordinator of 
activities such eligible entity proposes to carry 
out through a grant, cooperative agreement, or 
contract under this section; and 
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‘‘(B) a description of an advisory com-
mittee the entity will establish to provide guid-
ance for the entity on developing and imple-
menting a statewide or Tribal strategic plan to 
prevent FASD and provide for the identifica-
tion, treatment, and support of individuals with 
FASD and their families. 
‘‘(c) DEFINITION OF FASD-INFORMED.—For pur-
poses of this section, the term ‘FASD-informed’, with re-
spect to support or an intervention program, means that 
such support or intervention program uses culturally and 
linguistically informed evidence-based or practice-based 
interventions and appropriate resources to support an im-
proved quality of life for an individual with FASD and 
the family of such individual. 
‘‘SEC. 399I. STRENGTHENING CAPACITY AND EDUCATION 
FOR 
FETAL 
ALCOHOL 
SPECTRUM 
DIS-
ORDERS. 
‘‘(a) IN
GENERAL.—The Secretary shall award 
grants, contracts, or cooperative agreements, as the Sec-
retary determines appropriate, to public or nonprofit pri-
vate entities with demonstrated expertise in the field of 
fetal alcohol spectrum disorders (referred to in this section 
as ‘FASD’). Such awards shall be for the purposes of 
building local, Tribal, State, and nationwide capacities to 
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prevent the occurrence of FASD by carrying out the pro-
grams described in subsection (b). 
‘‘(b) PROGRAMS.—An entity receiving an award 
under subsection (a) may use such award for the following 
purposes: 
‘‘(1) Developing and supporting public edu-
cation and outreach activities to raise public aware-
ness of the risks associated with alcohol consumption 
during pregnancy. 
‘‘(2) Acting as a clearinghouse for evidence- 
based resources on FASD prevention, identification, 
and culturally and linguistically appropriate best 
practices to help inform systems of care for individ-
uals with FASD across their lifespan. 
‘‘(3) Increasing awareness and understanding 
of efficacious, evidence-based screening tools and 
culturally and linguistically appropriate evidence- 
based intervention services and best practices, which 
may include improving the capacity for State, Trib-
al, and local affiliates. 
‘‘(4) Providing technical assistance to recipients 
of grants, cooperative agreements, or contracts 
under section 399H, as appropriate. 
‘‘(c) APPLICATION.—To be eligible for a grant, con-
tract, or cooperative agreement under this section, an enti-
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ty shall submit to the Secretary an application at such 
time, in such manner, and containing such information as 
the Secretary may require. 
‘‘(d) SUBCONTRACTING.—A public or private non-
profit entity may carry out the following activities required 
under this section through contracts or cooperative agree-
ments with other public and private nonprofit entities with 
demonstrated expertise in FASD: 
‘‘(1) Resource development and dissemination. 
‘‘(2) Intervention services. 
‘‘(3) Training and technical assistance. 
‘‘SEC. 399J. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated to carry out 
this part $12,500,000 for each of fiscal years 2025 
through 2029.’’. 
(b) REPORT.—Not later than 4 years after the date 
of enactment of this Act, and every year thereafter, the 
Secretary of Health and Human Services shall prepare 
and 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 containing— 
(1) a review of the activities carried out pursu-
ant to sections 399H and 399I of the Public Health 
Service Act, as amended, to advance public edu-
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cation and awareness of fetal alcohol spectrum dis-
orders (referred to in this section as ‘‘FASD’’); 
(2) a description of— 
(A) the activities carried out pursuant to 
such sections 399H and 399I to identify, pre-
vent, and treat FASD; and 
(B) methods used to evaluate the outcomes 
of such activities; and 
(3) an assessment of activities carried out pur-
suant to such sections 399H and 399I to support in-
dividuals with FASD. 
SEC. 515. PROMOTING STATE CHOICE IN PDMP SYSTEMS. 
Section 399O(h) of the Public Health Service Act (42 
U.S.C. 280g–3(h)) is amended by adding at the end the 
following: 
‘‘(5) PROMOTING STATE CHOICE.—Nothing in 
this section shall be construed to authorize the Sec-
retary to require States to use a specific vendor or 
a specific interoperability connection other than to 
align with nationally recognized, consensus-based 
open standards, such as in accordance with sections 
3001 and 3004.’’. 
SEC. 516. FIRST RESPONDER TRAINING PROGRAM. 
Section 546 of the Public Health Service Act (42 
U.S.C. 290ee–1) is amended— 
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(1) in subsection (a), by striking ‘‘tribes and 
tribal’’ and inserting ‘‘Tribes and Tribal’’; 
(2) in subsections (a), (c), and (d)— 
(A) by striking ‘‘approved or cleared’’ each 
place it appears and inserting ‘‘approved, 
cleared, or otherwise legally marketed’’; and 
(B) by striking ‘‘opioid’’ each place it ap-
pears; 
(3) in subsection (f)— 
(A) by striking ‘‘approved or cleared’’ each 
place it appears and inserting ‘‘approved, 
cleared, or otherwise legally marketed’’; 
(B) in paragraph (1), by striking ‘‘opioid’’; 
(C) in paragraph (2)— 
(i) by striking ‘‘opioid and heroin’’ 
and inserting ‘‘opioid, heroin, and other 
drug’’; and 
(ii) by striking ‘‘opioid overdose’’ and 
inserting ‘‘overdose’’; and 
(D) in paragraph (3), by striking ‘‘opioid 
and heroin’’; and 
(4) in subsection (h), by striking ‘‘$36,000,000 
for each of fiscal years 2019 through 2023’’ and in-
serting ‘‘$56,000,000 for each of fiscal years 2025 
through 2029’’. 
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383 
SEC. 517. DONALD J. COHEN NATIONAL CHILD TRAUMATIC 
STRESS INITIATIVE. 
(a) TECHNICAL AMENDMENT.—The second part G of 
title V of the Public Health Service Act (42 U.S.C. 290kk 
et seq.), as added by section 144 of the Community Re-
newal Tax Relief Act (Public Law 106–554), is amend-
ed— 
(1) by redesignating such part as part J; and 
(2) by redesignating sections 581 through 584 
as sections 596 through 596C, respectively. 
(b) IN GENERAL.—Section 582 of the Public Health 
Service Act (42 U.S.C. 290hh–1) is amended— 
(1) in the section heading, by striking ‘‘VIO-
LENCE RELATED STRESS’’ and inserting ‘‘TRAU-
MATIC EVENTS’’; 
(2) in subsection (a)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘tribes and tribal’’ and inserting 
‘‘Tribes and Tribal’’; and 
(B) in paragraph (2), by inserting ‘‘and 
dissemination’’ after ‘‘the development’’; 
(3) in subsection (b), by inserting ‘‘and dissemi-
nation’’ after ‘‘the development’’; 
(4) in subsection (d)— 
(A) by striking ‘‘The NCTSI’’ and insert-
ing the following: 
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‘‘(1) COORDINATING
CENTER.—The NCTSI’’; 
and 
(B) by adding at the end the following: 
‘‘(2) NCTSI GRANTEES.—In carrying out sub-
section (a)(2), NCTSI grantees shall develop 
trainings and other resources, as applicable and ap-
propriate, to support implementation of the evi-
dence-based practices developed and disseminated 
under such subsection.’’; 
(5) in subsection (e)— 
(A) by redesignating paragraphs (1) and 
(2) as subparagraphs (A) and (B), respectively, 
and adjusting the margins accordingly; 
(B) in subparagraph (A), as so redesig-
nated, by inserting ‘‘and implementation’’ after 
‘‘the dissemination’’; 
(C) by striking ‘‘The NCTSI’’ and insert-
ing the following: 
‘‘(1) COORDINATING
CENTER.—The NCTSI’’; 
and 
(D) by adding at the end the following: 
‘‘(2) NCTSI 
GRANTEES.—NCTSI grantees 
shall, as appropriate, collaborate with other such 
grantees, the NCTSI coordinating center, and the 
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Secretary in carrying out subsections (a)(2) and 
(d)(2).’’; 
(6) by amending subsection (h) to read as fol-
lows: 
‘‘(h) APPLICATION AND EVALUATION.—To be eligible 
to receive a grant, contract, or cooperative agreement 
under subsection (a), a public or nonprofit private entity 
or an Indian Tribe or Tribal organization shall submit to 
the Secretary an application at such time, in such manner, 
and containing such information and assurances as the 
Secretary may require, including— 
‘‘(1) a plan for the evaluation of the activities 
funded under the grant, contract, or agreement, in-
cluding both process and outcomes evaluation, and 
the submission of an evaluation at the end of the 
project period; and 
‘‘(2) a description of how such entity, Indian 
Tribe, or Tribal organization will support efforts led 
by the Secretary or the NCTSI coordinating center, 
as applicable, to evaluate activities carried out under 
this section.’’; and 
(7) by amending subsection (j) to read as fol-
lows: 
‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section— 
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‘‘(1) $93,887,000 for fiscal year 2025; 
‘‘(2) $95,000,000 for fiscal year 2026; 
‘‘(3) $97,000,000 for fiscal year 2027; 
‘‘(4) $100,000,000 for fiscal year 2028; and 
‘‘(5) $100,000,000 for fiscal year 2029.’’. 
SEC. 518. PROTECTING SUICIDE PREVENTION LIFELINE 
FROM CYBERSECURITY INCIDENTS. 
(a) NATIONAL SUICIDE PREVENTION LIFELINE PRO-
GRAM.—Section 520E–3(b) of the Public Health Service 
Act (42 U.S.C. 290bb–36c(b)) is amended— 
(1) in paragraph (4), by striking ‘‘and’’ at the 
end; 
(2) in paragraph (5), by striking the period at 
the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(6) taking such steps as may be necessary to 
ensure the suicide prevention hotline is protected 
from cybersecurity incidents and eliminates known 
cybersecurity vulnerabilities.’’. 
(b) REPORTING.—Section 520E–3 of the Public 
Health Service Act (42 U.S.C. 290bb–36c) is amended— 
(1) by redesignating subsection (f) as sub-
section (g); and 
(2) by inserting after subsection (e) the fol-
lowing: 
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‘‘(f) CYBERSECURITY REPORTING.— 
‘‘(1) NOTIFICATION.— 
‘‘(A) IN
GENERAL.—The program’s net-
work administrator receiving Federal funding 
pursuant to subsection (a) shall report to the 
Assistant Secretary, in a manner that protects 
personal privacy, consistent with applicable 
Federal and State privacy laws— 
‘‘(i) 
any 
identified 
cybersecurity 
vulnerabilities to the program within a rea-
sonable amount of time after identification 
of such a vulnerability; and 
‘‘(ii) any identified cybersecurity inci-
dents to the program within a reasonable 
amount of time after identification of such 
incident. 
‘‘(B) LOCAL AND REGIONAL CRISIS CEN-
TERS.—Local and regional crisis centers par-
ticipating in the program shall report to the 
program’s network administrator identified 
under subparagraph (A), in a manner that pro-
tects personal privacy, consistent with applica-
ble Federal and State privacy laws— 
‘‘(i) 
any 
identified 
cybersecurity 
vulnerabilities to the program within a rea-
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sonable amount of time after identification 
of such vulnerability; and 
‘‘(ii) any identified cybersecurity inci-
dents to the program within a reasonable 
amount of time after identification of such 
incident. 
‘‘(2) NOTIFICATION.—If the program’s network 
administrator receiving funding pursuant to sub-
section (a) discovers, or is informed by a local or re-
gional crisis center pursuant to paragraph (1)(B) of, 
a cybersecurity vulnerability or incident, within a 
reasonable amount of time after such discovery or 
receipt of information, such entity shall report the 
vulnerability or incident to the Assistant Secretary. 
‘‘(3) CLARIFICATION.— 
‘‘(A) OVERSIGHT.— 
‘‘(i) LOCAL
AND
REGIONAL
CRISIS 
CENTERS.—Except as provided in clause 
(ii), local and regional crisis centers par-
ticipating in the program shall oversee all 
technology each center employs in the pro-
vision of services as a participant in the 
program. 
‘‘(ii) NETWORK
ADMINISTRATOR.— 
The program’s network administrator re-
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ceiving Federal funding pursuant to sub-
section (a) shall oversee the technology 
each crisis center employs in the provision 
of services as a participant in the program 
if such oversight responsibilities are estab-
lished in the applicable network participa-
tion agreement. 
‘‘(B) SUPPLEMENT, NOT SUPPLANT.—The 
cybersecurity incident reporting requirements 
under this subsection shall supplement, and not 
supplant, cybersecurity incident reporting re-
quirements under other provisions of applicable 
Federal law that are in effect on the date of the 
enactment of the SUPPORT for Patients and 
Communities Reauthorization Act of 2025.’’. 
(c) STUDY.—Not later than 180 days after the date 
of the enactment of this Act, the Comptroller General of 
the United States shall— 
(1) conduct and complete a study that evaluates 
cybersecurity risks and vulnerabilities associated 
with the 9–8–8 National Suicide Prevention Lifeline; 
and 
(2) submit a report on the findings of such 
study to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
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mittee on Energy and Commerce of the House of 
Representatives. 
SEC. 519. BRUCE’S LAW. 
(a) YOUTH PREVENTION AND RECOVERY.—Section 
7102(c) of the SUPPORT for Patients and Communities 
Act (42 U.S.C. 290bb–7a(c)) is amended— 
(1) in paragraph (3)(A)(i), by inserting ‘‘, 
which may include strategies to increase education 
and awareness of the potency and dangers of syn-
thetic opioids (including drugs contaminated with 
fentanyl) and, as appropriate, other emerging drug 
use or misuse issues’’ before the semicolon; and 
(2) in paragraph (4)(A), by inserting ‘‘and 
strategies to increase education and awareness of 
the potency and dangers of synthetic opioids (includ-
ing drugs contaminated with fentanyl) and, as ap-
propriate, emerging drug use or misuse issues’’ be-
fore the semicolon. 
(b) INTERDEPARTMENTAL SUBSTANCE USE DIS-
ORDERS COORDINATING COMMITTEE.—Section 7022 of 
the SUPPORT for Patients and Communities Act (42 
U.S.C. 290aa note) is amended— 
(1) by striking subsection (g) and inserting the 
following: 
‘‘(g) WORKING GROUPS.— 
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‘‘(1) IN GENERAL.—The Committee may estab-
lish working groups for purposes of carrying out the 
duties described in subsection (e). Any such working 
group shall be composed of members of the Com-
mittee (or the designees of such members) and may 
hold such meetings as are necessary to carry out the 
duties delegated to the working group. 
‘‘(2) 
ADDITIONAL
FEDERAL
INTERAGENCY 
WORK GROUP ON FENTANYL CONTAMINATION OF IL-
LEGAL DRUGS.— 
‘‘(A) ESTABLISHMENT.—The Secretary, 
acting through the Committee, shall establish a 
Federal Interagency Work Group on Fentanyl 
Contamination of Illegal Drugs (referred to in 
this paragraph as the ‘Work Group’) consisting 
of representatives from relevant Federal depart-
ments and agencies on the Committee. 
‘‘(B) CONSULTATION.—The Work Group 
shall consult with relevant stakeholders and 
subject matter experts, including— 
‘‘(i) State, Tribal, and local subject 
matter experts in reducing, preventing, and 
responding to drug overdose caused by 
fentanyl contamination of illicit drugs; and 
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‘‘(ii) family members of both adults 
and youth who have overdosed by fentanyl- 
contaminated illicit drugs. 
‘‘(C) DUTIES.—The Work Group shall— 
‘‘(i) examine Federal efforts to reduce 
and prevent drug overdose by fentanyl-con-
taminated illicit drugs; 
‘‘(ii) identify strategies to improve 
State, Tribal, and local responses to over-
dose by fentanyl-contaminated illicit drugs; 
‘‘(iii) coordinate with the Secretary, as 
appropriate, in carrying out activities to 
raise public awareness of synthetic opioids 
and other emerging drug use and misuse 
issues; 
‘‘(iv) make recommendations to Con-
gress for improving Federal programs, in-
cluding with respect to the coordination of 
efforts across such programs; and 
‘‘(v) make recommendations for edu-
cating youth on the potency and dangers of 
drugs contaminated by fentanyl. 
‘‘(D) ANNUAL REPORT TO SECRETARY.— 
The Work Group shall annually prepare and 
submit to the Secretary, the Committee on 
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Health, Education, Labor, and Pensions of the 
Senate, and the Committee on Energy and 
Commerce and the Committee on Education 
and the Workforce of the House of Representa-
tives, a report on the activities carried out by 
the Work Group under subparagraph (C), in-
cluding recommendations to reduce and prevent 
drug overdose by fentanyl contamination of ille-
gal drugs, in all populations, and specifically 
among youth at risk for substance misuse.’’; 
and 
(2) by striking subsection (i) and inserting the 
following: 
‘‘(i) SUNSET.—The Committee shall 
terminate on September 30, 2029.’’. 
SEC. 520. GUIDANCE ON AT-HOME DRUG DISPOSAL SYS-
TEMS. 
(a) IN GENERAL.—Not later than one 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, shall publish 
guidance to facilitate the use of at-home safe disposal sys-
tems for applicable drugs. 
(b) CONTENTS.—The guidance under subsection (a) 
shall include— 
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(1) recommended standards for effective at- 
home drug disposal systems to meet applicable re-
quirements enforced by the Food and Drug Adminis-
tration; 
(2) recommended information to include as in-
structions for use to disseminate with at-home drug 
disposal systems; 
(3) best practices and educational tools to sup-
port the use of an at-home drug disposal system, as 
appropriate; and 
(4) recommended use of licensed health pro-
viders for the dissemination of education, instruc-
tion, and at-home drug disposal systems, as appro-
priate. 
SEC. 521. ASSESSMENT OF OPIOID DRUGS AND ACTIONS. 
(a) IN GENERAL.—Not later than one year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall publish on the website of the Food and 
Drug Administration (referred to in this section as the 
‘‘FDA’’) a report that outlines a plan for assessing opioid 
analgesic drugs that are approved under section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) that addresses the public health effects of such opioid 
analgesic drugs as part of the benefit-risk assessment and 
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the activities of the FDA that relate to facilitating the de-
velopment of nonaddictive medical products intended to 
treat pain or addiction. Such report shall include— 
(1) an update on the actions taken by the FDA 
to consider the effectiveness, safety, benefit-risk pro-
file, and use of approved opioid analgesic drugs; 
(2) a timeline for an assessment of the potential 
need, as appropriate, for labeling changes, revised or 
additional postmarketing requirements, enforcement 
actions, or withdrawals for opioid analgesic drugs; 
(3) an overview of the steps that the FDA has 
taken to support the development and approval of 
nonaddictive medical products intended to treat pain 
or addiction, and actions planned to further support 
the development and approval of such products; and 
(4) an overview of the consideration by the 
FDA of clinical trial methodologies for analgesic 
drugs, including the enriched enrollment randomized 
withdrawal methodology, and the benefits and draw-
backs associated with different trial methodologies 
for such drugs, incorporating any public input re-
ceived under subsection (b). 
(b) PUBLIC INPUT.—In carrying out subsection (a), 
the Secretary shall provide an opportunity for public input 
concerning the regulation by the FDA of opioid analgesic 
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drugs, including scientific evidence that relates to condi-
tions of use, safety, or benefit-risk assessment (including 
consideration of the public health effects) of such opioid 
analgesic drugs. 
SEC. 522. GRANT PROGRAM FOR STATE AND TRIBAL RE-
SPONSE TO OPIOID USE DISORDERS. 
The activities carried out pursuant to section 
1003(b)(4)(A) of the 21st Century Cures Act (42 U.S.C. 
290ee–3a(b)(4)(A)) may include facilitating access to 
products used to prevent overdose deaths by detecting the 
presence of one or more substances, such as fentanyl and 
xylazine test strips, to the extent the purchase and posses-
sion of such products is consistent with Federal and State 
law. 
Subtitle B—Treatment 
SEC. 531. RESIDENTIAL TREATMENT PROGRAM FOR PREG-
NANT AND POSTPARTUM WOMEN. 
Section 508 of the Public Health Service Act (42 
U.S.C. 290bb–1) is amended— 
(1) in subsection (d)(11)(C), by striking ‘‘pro-
viding health services’’ and inserting ‘‘providing 
health care services’’; 
(2) in subsection (g)— 
(A) by inserting ‘‘a plan describing’’ after 
‘‘will provide’’; and 
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(B) by adding at the end the following: 
‘‘Such plan may include a description of how 
such applicant will target outreach to women 
disproportionately impacted by maternal sub-
stance use disorder.’’; and 
(3) in subsection (s), by striking ‘‘$29,931,000 
for each of fiscal years 2019 through 2023’’ and in-
serting ‘‘$38,931,000 for each of fiscal years 2025 
through 2029’’. 
SEC. 532. IMPROVING ACCESS TO ADDICTION MEDICINE 
PROVIDERS. 
Section 597 of the Public Health Service Act (42 
U.S.C. 290ll) is amended— 
(1) in subsection (a)(1), by inserting ‘‘diag-
nosis,’’ after ‘‘related to’’; and 
(2) in subsection (b), by inserting ‘‘addiction 
medicine,’’ after ‘‘psychiatry,’’. 
SEC. 533. MENTAL AND BEHAVIORAL HEALTH EDUCATION 
AND TRAINING GRANTS. 
Section 756(f) of the Public Health Service Act (42 
U.S.C. 294e–1(f)) is amended by striking ‘‘fiscal years 
2023 through 2027’’ and inserting ‘‘fiscal years 2025 
through 2029’’. 
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398 
SEC. 534. LOAN REPAYMENT PROGRAM FOR SUBSTANCE 
USE DISORDER TREATMENT WORKFORCE. 
Section 781(j) of the Public Health Service Act (42 
U.S.C. 295h(j)) is amended by striking ‘‘$25,000,000 for 
each of fiscal years 2019 through 2023’’ and inserting 
‘‘$40,000,000 for each of fiscal years 2025 through 
2029’’. 
SEC. 535. DEVELOPMENT AND DISSEMINATION OF MODEL 
TRAINING PROGRAMS FOR SUBSTANCE USE 
DISORDER PATIENT RECORDS. 
Section 7053 of the SUPPORT for Patients and 
Communities Act (42 U.S.C. 290dd–2 note) is amended 
by striking subsection (e). 
SEC. 536. TASK FORCE ON BEST PRACTICES FOR TRAUMA- 
INFORMED IDENTIFICATION, REFERRAL, AND 
SUPPORT. 
Section 7132 of the SUPPORT for Patients and 
Communities Act (Public Law 115–271; 132 Stat. 4046) 
is amended— 
(1) in subsection (b)(1)— 
(A) by redesignating subparagraph (CC) as 
subparagraph (DD); and 
(B) by inserting after subparagraph (BB) 
the following: 
‘‘(CC) The Administration for Community 
Living.’’; 
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(2) in subsection (d)(1), in the matter pre-
ceding subparagraph (A), by inserting ‘‘, develop-
mental disability service providers’’ before ‘‘, individ-
uals who are’’; and 
(3) in subsection (i), by striking ‘‘2023’’ and in-
serting ‘‘2029’’. 
SEC. 537. GRANTS TO ENHANCE ACCESS TO SUBSTANCE 
USE DISORDER TREATMENT. 
Section 3203 of the SUPPORT for Patients and 
Communities Act (21 U.S.C. 823 note) is amended— 
(1) by striking subsection (b); and 
(2) by striking ‘‘(a) IN GENERAL.—The Sec-
retary’’ and inserting the following: ‘‘The Sec-
retary’’. 
SEC. 538. STATE GUIDANCE RELATED TO INDIVIDUALS 
WITH SERIOUS MENTAL ILLNESS AND CHIL-
DREN WITH SERIOUS EMOTIONAL DISTURB-
ANCE. 
(a) REVIEW OF USE OF CERTAIN FUNDING.—Not 
later than 1 year after the date of enactment of this Act, 
the Secretary of Health and Human Services (referred to 
in this section as the ‘‘Secretary’’), acting through the As-
sistant Secretary for Mental Health and Substance Use, 
shall conduct a review of State use of funds made available 
under the Community Mental Health Services Block 
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Grant program under subpart I of part B of title XIX 
of the Public Health Service Act (42 U.S.C. 300x et seq.) 
(referred to in this section as the ‘‘block grant program’’) 
for first episode psychosis activities. Such review shall con-
sider the following: 
(1) How States use funds for evidence-based 
treatments and services according to the standard of 
care for individuals with early serious mental illness 
and children with a serious emotional disturbance. 
(2) The percentages of the State funding under 
the block grant program expended on early serious 
mental illness and first episode psychosis, and the 
number of individuals served under such funds. 
(b) REPORT AND GUIDANCE.— 
(1) REPORT.—Not later than 180 days after 
the completion of the review under subsection (a), 
the Secretary shall submit to the Committee on 
Health, Education, Labor, and Pensions and the 
Committee on Appropriations of the Senate and the 
Committee on Energy and Commerce and the Com-
mittee on Appropriations of the House of Represent-
atives a report describing— 
(A) the findings of the review under sub-
section (a); and 
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(B) any recommendations for changes to 
the block grant program that would facilitate 
improved outcomes for individuals with serious 
mental illness and children with serious emo-
tional disturbance. 
(2) GUIDANCE.—Not later than 1 year after 
the date on which the report is submitted under 
paragraph (1), the Secretary shall update the guid-
ance provided to States under the block grant pro-
gram on coordinated specialty care and other evi-
dence-based mental health care services for individ-
uals with serious mental illness and children with a 
serious emotional disturbance, based on the findings 
and recommendations of such report. 
SEC. 539. REVIEWING THE SCHEDULING OF APPROVED 
PRODUCTS CONTAINING A COMBINATION OF 
BUPRENORPHINE AND NALOXONE. 
(a) SECRETARY OF HHS.—The Secretary of Health 
and Human Services shall, consistent with the require-
ments and procedures set forth in sections 201 and 202 
of the Controlled Substances Act (21 U.S.C. 811, 812)— 
(1) review the relevant data pertaining to the 
scheduling of products containing a combination of 
buprenorphine and naloxone that have been ap-
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proved under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355); and 
(2) if appropriate, request that the Attorney 
General initiate rulemaking proceedings to revise the 
schedules accordingly with respect to such products. 
(b) ATTORNEY GENERAL.—The Attorney General 
shall review any request made by the Secretary of Health 
and Human Services under subsection (a)(2) and deter-
mine whether to initiate proceedings to revise the sched-
ules in accordance with the criteria set forth in sections 
201 and 202 of the Controlled Substances Act (21 U.S.C. 
811, 812). 
Subtitle C—Recovery 
SEC. 541. BUILDING COMMUNITIES OF RECOVERY. 
Section 547(f) of the Public Health Service Act (42 
U.S.C. 290ee–2(f)) is amended by striking ‘‘$5,000,000 
for each of fiscal years 2019 through 2023’’ and inserting 
‘‘$16,000,000 for each of fiscal years 2025 through 
2029’’. 
SEC. 542. PEER SUPPORT TECHNICAL ASSISTANCE CEN-
TER. 
Section 547A of the Public Health Service Act (42 
U.S.C. 290ee–2a) is amended— 
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(1) in subsection (b)(4), by striking ‘‘building; 
and’’ and inserting the following: ‘‘building, such 
as— 
‘‘(A) professional development of peer sup-
port specialists; and 
‘‘(B) making recovery support services 
available in nonclinical settings; and’’; 
(2) by redesignating subsections (d) and (e) as 
subsections (e) and (f), respectively; 
(3) by inserting after subsection (c) the fol-
lowing: 
‘‘(d) REGIONAL CENTERS.— 
‘‘(1) IN GENERAL.—The Secretary may estab-
lish one regional technical assistance center (referred 
to in this subsection as the ‘Regional Center’), with 
existing resources, to assist the Center in carrying 
out activities described in subsection (b) within the 
geographic region of such Regional Center in a man-
ner that is tailored to the needs of such region. 
‘‘(2) EVALUATION.—Not later than 4 years 
after the date of enactment of the SUPPORT for 
Patients and Communities Reauthorization Act of 
2024, the Secretary shall evaluate the activities of 
the Regional Center and submit to the Committee 
on Health, Education, Labor, and Pensions of the 
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Senate and the Committee on Energy and Com-
merce of the House of Representatives a report on 
the findings of such evaluation, including— 
‘‘(A) a description of the distinct roles and 
responsibilities of the Regional Center and the 
Center; 
‘‘(B) available information relating to the 
outcomes of the Regional Center under this 
subsection, such as any impact on the oper-
ations and efficiency of the Center relating to 
requests for technical assistance and support 
within the region of such Regional Center; 
‘‘(C) a description of any gaps or areas of 
duplication relating to the activities of the Re-
gional Center and the Center within such re-
gion; and 
‘‘(D) recommendations relating to the 
modification, expansion, or termination of the 
Regional Center under this subsection. 
‘‘(3) TERMINATION.—This subsection shall ter-
minate on September 30, 2029.’’; and 
(4) in subsection (f), as so redesignated, by 
striking ‘‘$1,000,000 for each of fiscal years 2019 
through 2023’’ and inserting ‘‘$2,000,000 for each 
of fiscal years 2025 through 2029’’. 
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SEC. 543. COMPREHENSIVE OPIOID RECOVERY CENTERS. 
Section 552 of the Public Health Service Act (42 
U.S.C. 290ee–7) is amended— 
(1) in subsection (d)(2)— 
(A) in the matter preceding subparagraph 
(A), by striking ‘‘and in such manner’’ and in-
serting ‘‘, in such manner, and containing such 
information and assurances, including relevant 
documentation,’’; and 
(B) in subparagraph (A), by striking ‘‘is 
capable of coordinating with other entities to 
carry out’’ and inserting ‘‘has the demonstrated 
capability to carry out, through referral or con-
tractual arrangements’’; 
(2) in subsection (h)— 
(A) 
by 
redesignating 
paragraphs 
(1) 
through (4) as subparagraphs (A) through (D), 
respectively, and adjusting the margins accord-
ingly; 
(B) by striking ‘‘With respect to’’ and in-
serting the following: 
‘‘(1) IN GENERAL.—With respect to’’; and 
(C) by adding at the end the following: 
‘‘(2) ADDITIONAL REPORTING FOR CERTAIN EL-
IGIBLE ENTITIES.—An entity carrying out activities 
described in subsection (g) through referral or con-
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tractual arrangements shall include in the submis-
sions required under paragraph (1) information re-
lated to the status of such referrals or contractual 
arrangements, including an assessment of whether 
such referrals or contractual arrangements are sup-
porting the ability of such entity to carry out such 
activities.’’; and 
(3) in subsection (j), by striking ‘‘2019 through 
2023’’ and inserting ‘‘2025 through 2029’’. 
SEC. 544. YOUTH PREVENTION AND RECOVERY. 
Section 7102(c) of the SUPPORT for Patients and 
Communities Act (42 U.S.C. 290bb–7a(c)) (as amended 
by section 110(a)) is amended— 
(1) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) in clause (i)— 
(I) by inserting ‘‘, or a consor-
tium of local educational agencies,’’ 
after ‘‘a local educational agency’’; 
and 
(II) by striking ‘‘high schools’’ 
and inserting ‘‘secondary schools’’; 
and 
(ii) in clause (vi), by striking ‘‘tribe, 
or tribal’’ and inserting ‘‘Tribe, or Tribal’’; 
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(B) by amending subparagraph (E) to read 
as follows: 
‘‘(E) INDIAN
TRIBE; TRIBAL
ORGANIZA-
TION.—The terms ‘Indian Tribe’ and ‘Tribal 
organization’ have the meanings given such 
terms in section 4 of the Indian Self-Deter-
mination and Education Assistance Act (25 
U.S.C. 5304).’’; 
(C) by redesignating subparagraph (K) as 
subparagraph (L); and 
(D) by inserting after subparagraph (J) 
the following: 
‘‘(K) SECONDARY
SCHOOL.—The term 
‘secondary school’ has the meaning given such 
term in section 8101 of the Elementary and 
Secondary Education Act of 1965 (20 U.S.C. 
7801).’’; 
(2) in paragraph (3)(A), in the matter pre-
ceding clause (i)— 
(A) by striking ‘‘and abuse’’; and 
(B) by inserting ‘‘at increased risk for sub-
stance misuse’’ after ‘‘specific populations’’; 
(3) in paragraph (4)— 
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(A) in the matter preceding subparagraph 
(A), by striking ‘‘Indian tribes’’ and inserting 
‘‘Indian Tribes’’; 
(B) in subparagraph (A), by striking ‘‘and 
abuse’’; and 
(C) in subparagraph (B), by striking ‘‘peer 
mentoring’’ and inserting ‘‘peer-to-peer sup-
port’’; 
(4) in paragraph (5), by striking ‘‘tribal’’ and 
inserting ‘‘Tribal’’; 
(5) in paragraph (6)(A)— 
(A) in clause (iv), by striking ‘‘; and’’ and 
inserting a semicolon; and 
(B) by adding at the end the following: 
‘‘(vi) a plan to sustain the activities 
carried out under the grant program, after 
the grant program has ended; and’’; 
(6) in paragraph (8), by striking ‘‘2022’’ and 
inserting ‘‘2027’’; and 
(7) by amending paragraph (9) to read as fol-
lows: 
‘‘(9) AUTHORIZATION
OF
APPROPRIATIONS.— 
To carry out this subsection, there are authorized to 
be appropriated— 
‘‘(A) $10,000,000 for fiscal year 2025; 
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‘‘(B) $12,000,000 for fiscal year 2026; 
‘‘(C) $13,000,000 for fiscal year 2027; 
‘‘(D) $14,000,000 for fiscal year 2028; 
and 
‘‘(E) $15,000,000 for fiscal year 2029.’’. 
SEC. 545. CAREER ACT. 
(a) IN GENERAL.—Section 7183 of the SUPPORT 
for Patients and Communities Act (42 U.S.C. 290ee–8) 
is amended— 
(1) in the section heading, by inserting ‘‘; 
TREATMENT, 
RECOVERY, 
AND
WORKFORCE 
SUPPORT GRANTS’’ after ‘‘CAREER ACT’’; 
(2) in subsection (b), by inserting ‘‘each’’ before 
‘‘for a period’’; 
(3) in subsection (c)— 
(A) in paragraph (1), by striking ‘‘the 
rates described in paragraph (2)’’ and inserting 
‘‘the average rates for calendar years 2018 
through 2022 described in paragraph (2)’’; and 
(B) by amending paragraph (2) to read as 
follows: 
‘‘(2) RATES.—The rates described in this para-
graph are the following: 
‘‘(A) The highest age-adjusted average 
rates of drug overdose deaths for calendar years 
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2018 through 2022 based on data from the 
Centers for Disease Control and Prevention, in-
cluding, if necessary, provisional data for cal-
endar year 2022. 
‘‘(B) The highest average rates of unem-
ployment for calendar years 2018 through 2022 
based on data provided by the Bureau of Labor 
Statistics. 
‘‘(C) The lowest average labor force par-
ticipation rates for calendar years 2018 through 
2022 based on data provided by the Bureau of 
Labor Statistics.’’; 
(4) in subsection (g)— 
(A) in each of paragraphs (1) and (3), by 
redesignating subparagraphs (A) and (B) as 
clauses (i) and (ii), respectively, and adjusting 
the margins accordingly; 
(B) 
by 
redesignating 
paragraphs 
(1) 
through (3) as subparagraphs (A) through (C), 
respectively, and adjusting the margins accord-
ingly; 
(C) in the matter preceding subparagraph 
(A) (as so redesignated), by striking ‘‘An enti-
ty’’ and inserting the following: 
‘‘(1) IN GENERAL.—An entity’’; and 
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(D) by adding at the end the following: 
‘‘(2) TRANSPORTATION
SERVICES.—An entity 
receiving a grant under this section may use not 
more than 5 percent of the funds for providing 
transportation for individuals to participate in an ac-
tivity supported by a grant under this section, which 
transportation shall be to or from a place of work 
or a place where the individual is receiving voca-
tional education or job training services or receiving 
services directly linked to treatment of or recovery 
from a substance use disorder. 
‘‘(3) LIMITATION.—The Secretary may not re-
quire an entity to, or give priority to an entity that 
plans to, use the funds of a grant under this section 
for activities that are not specified in this sub-
section.’’; 
(5) in subsection (i)(2), by inserting ‘‘, which 
shall include employment and earnings outcomes de-
scribed in subclauses (I) and (III) of section 
116(b)(2)(A)(i) of the Workforce Innovation and 
Opportunity Act (29 U.S.C. 3141(b)(2)(A)(i)) with 
respect to the participation of such individuals with 
a substance use disorder in programs and activities 
funded by the grant under this section’’ after ‘‘sub-
section (g)’’; 
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(6) in subsection (j)— 
(A) in paragraph (1), by inserting ‘‘for 
grants awarded prior to the date of enactment 
of the SUPPORT for Patients and Commu-
nities Reauthorization Act of 2025’’ after 
‘‘grant period under this section’’; and 
(B) in paragraph (2)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘2 years after sub-
mitting the preliminary report required 
under paragraph (1)’’ and inserting ‘‘Sep-
tember 30, 2029’’; and 
(ii) in subparagraph (A), by striking 
‘‘(g)(3)’’ and inserting ‘‘(g)(1)(C)’’; and 
(7) in subsection (k), by striking ‘‘$5,000,000 
for each of fiscal years 2019 through 2023’’ and in-
serting ‘‘$12,000,000 for each of fiscal years 2025 
through 2029’’. 
(b) REAUTHORIZATION OF THE CAREER ACT; RE-
COVERY HOUSING PILOT PROGRAM.— 
(1) IN GENERAL.—Section 8071 of the SUP-
PORT for Patients and Communities Act (42 
U.S.C. 5301 note; Public Law 115–271) is amend-
ed— 
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(A) by striking the section heading and in-
serting ‘‘CAREER ACT; RECOVERY HOUSING 
PILOT PROGRAM’’; 
(B) in subsection (a), by striking ‘‘through 
2023’’ and inserting ‘‘through 2029’’; 
(C) in subsection (b)— 
(i) in paragraph (1), by striking ‘‘not 
later than 60 days after the date of enact-
ment of this Act’’ and inserting ‘‘not later 
than 60 days after the date of enactment 
of SUPPORT for Patients and Commu-
nities Reauthorization Act of 2025’’; and 
(ii) in paragraph (2)(B)(i)— 
(I) in subclause (I)— 
(aa) by striking ‘‘for cal-
endar years 2013 through 2017’’; 
and 
(bb) by inserting ‘‘for cal-
endar years 2018 through 2022’’ 
after ‘‘rates of unemployment’’; 
(II) in subclause (II)— 
(aa) by striking ‘‘for cal-
endar years 2013 through 2017’’; 
and 
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(bb) by inserting ‘‘for cal-
endar years 2018 through 2022’’ 
after ‘‘participation rates’’; and 
(III) by striking subclause (III) 
and inserting the following: 
‘‘(III) The highest age-adjusted 
average rates of drug overdose deaths 
for calendar years 2018 through 2022 
based on data from the Centers for 
Disease Control and Prevention, in-
cluding, if necessary, provisional data 
for calendar year 2022.’’; and 
(D) in subsection (f), by striking ‘‘For the 
2-year period following the date of enactment of 
this Act, the’’ and inserting ‘‘The’’. 
(2) CONFORMING AMENDMENT.—Subtitle F of 
title VIII of the SUPPORT for Patients and Com-
munities Act (Public Law 115–271; 132 Stat. 4095) 
is amended by striking the subtitle heading and in-
serting the following: ‘‘Subtitle F—CAREER 
Act; Recovery Housing Pilot Program’’ . 
(c) CLERICAL AMENDMENTS.—The table of contents 
in section 1(b) of the SUPPORT for Patients and Com-
munities Act (Public Law 115–271; 132 Stat. 3894) is 
amended— 
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(1) by striking the item relating to section 7183 
and inserting the following: 
‘‘Sec. 7183. CAREER Act; treatment, recovery, and workforce support 
grants.’’; 
(2) by striking the item relating to subtitle F 
of title VIII and inserting the following: 
‘‘Subtitle F—CAREER Act; Recovery Housing Pilot Program’’; and 
(3) by striking the item relating to section 8071 
and inserting the following: 
‘‘Sec. 8071. CAREER Act; Recovery Housing Pilot Program.’’. 
SEC. 546. ADDRESSING ECONOMIC AND WORKFORCE IM-
PACTS OF THE OPIOID CRISIS. 
Section 8041(g)(1) of the SUPPORT for Patients 
and Communities Act (29 U.S.C. 3225a(g)(1)) is amended 
by striking ‘‘2023’’ and inserting ‘‘2029’’. 
Subtitle D—Miscellaneous Matters 
SEC. 551. DELIVERY OF A CONTROLLED SUBSTANCE BY A 
PHARMACY 
TO 
A 
PRESCRIBING 
PRACTI-
TIONER. 
Section 309A(a) of the Controlled Substances Act 
(21 U.S.C. 829a(a)) is amended by striking paragraph (2) 
and inserting the following: 
‘‘(2) the controlled substance is a drug in 
schedule III, IV, or V to be administered— 
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‘‘(A) by injection or implantation for the 
purpose of maintenance or detoxification treat-
ment; or 
‘‘(B) subject to a risk evaluation and miti-
gation strategy pursuant to section 505–1 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355–1) that includes elements to assure 
safe use of the drug described in subsection 
(f)(3)(E) of such section, including a require-
ment for post-administration monitoring by a 
health care provider.’’. 
SEC. 552. TECHNICAL CORRECTION ON CONTROLLED SUB-
STANCES DISPENSING. 
Effective as if included in the enactment of Public 
Law 117–328— 
(1) section 1252(a) of division FF of Public 
Law 117–328 (136 Stat. 5681) is amended, in the 
matter being inserted into section 302(e) of the Con-
trolled Substances Act, by striking ‘‘303(g)’’ and in-
serting ‘‘303(h)’’; 
(2) section 1262 of division FF of Public Law 
117–328 (136 Stat. 5681) is amended— 
(A) in subsection (a)— 
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(i) in the matter preceding paragraph 
(1), by striking ‘‘303(g)’’ and inserting 
‘‘303(h)’’; 
(ii) in the matter being stricken by 
subsection (a)(2), by striking ‘‘(g)(1)’’ and 
inserting ‘‘(h)(1)’’; and 
(iii) in the matter being inserted by 
subsection (a)(2), by striking ‘‘(g) Practi-
tioners’’ and inserting ‘‘(h) Practitioners’’; 
and 
(B) in subsection (b)— 
(i) in the matter being stricken by 
paragraph (1), by striking ‘‘303(g)(1)’’ 
and inserting ‘‘303(h)(1)’’; 
(ii) in the matter being inserted by 
paragraph (1), by striking ‘‘303(g)’’ and 
inserting ‘‘303(h)’’; 
(iii) in the matter being stricken by 
paragraph (2)(A), by striking ‘‘303(g)(2)’’ 
and inserting ‘‘303(h)(2)’’; 
(iv) in the matter being stricken by 
paragraph (3), by striking ‘‘303(g)(2)(B)’’ 
and inserting ‘‘303(h)(2)(B)’’; 
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(v) in the matter being stricken by 
paragraph (5), by striking ‘‘303(g)’’ and 
inserting ‘‘303(h)’’; and 
(vi) in the matter being stricken by 
paragraph (6), by striking ‘‘303(g)’’ and 
inserting ‘‘303(h)’’; and 
(3) section 1263(b) of division FF of Public 
Law 117–328 (136 Stat. 5685) is amended— 
(A) by striking ‘‘303(g)(2)’’ and inserting 
‘‘303(h)(2)’’; and 
(B) by striking ‘‘(21 U.S.C. 823(g)(2))’’ 
and inserting ‘‘(21 U.S.C. 823(h)(2))’’. 
SEC. 553. REQUIRED TRAINING FOR PRESCRIBERS OF CON-
TROLLED SUBSTANCES. 
(a) IN GENERAL.—Section 303 of the Controlled 
Substances Act (21 U.S.C. 823) is amended— 
(1) by redesignating the second subsection des-
ignated as subsection (l) as subsection (m); and 
(2) in subsection (m)(1), as so redesignated— 
(A) in subparagraph (A)— 
(i) in clause (iv)— 
(I) in subclause (I)— 
(aa) by inserting ‘‘the Amer-
ican Academy of Family Physi-
cians, the American Podiatric 
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(B) in subparagraph (A), by inserting ‘‘, 
including requests from State or Tribal health 
officials’’ before the semicolon; 
(4) in paragraph (7)(A), by striking ‘‘tribal or-
ganization’’ and inserting ‘‘Tribal organization’’; and 
(5) in paragraph (8), by striking ‘‘March 31, 
2025’’ and inserting ‘‘December 31, 2026’’. 
SEC. 612. PUBLIC HEALTH EMERGENCY PREPAREDNESS 
PROGRAM. 
Section 319C–1 of the Public Health Service Act (42 
U.S.C. 247d–3a) is amended— 
(1) in subsection (b)(2)— 
(A) in subparagraph (A)(ii), by striking 
‘‘influenza’’ and inserting ‘‘response planning’’; 
and 
(B) in subparagraph (H), by inserting ‘‘, 
such as community-based organizations, includ-
ing faith-based organizations, and other public 
and private entities’’ after ‘‘stakeholders’’; 
(2) in subsection (g)— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by inserting ‘‘and the 
ability of each entity receiving an award under 
subsection (a) to respond to all-hazards 
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and submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives a coordinated strategy for medical 
countermeasures to address chemical, biological, ra-
diological, and nuclear threats, informed by the re-
quirements 
developed 
pursuant 
to 
subsection 
(b)(3)(B). Not later than 180 days after the submis-
sion of such strategy to such committees, the Assist-
ant Secretary for Preparedness and Response shall 
submit an accompanying implementation plan to 
such committees. In developing such a strategy and 
plan, the Assistant Secretary for Preparedness and 
Response shall consult with the Public Health Emer-
gency Medical Countermeasures Enterprise estab-
lished under section 2811–1. Such strategy and plan 
shall be known as the Public Health Emergency 
Medical Countermeasures Enterprise Strategy and 
Implementation Plan.’’; and 
(B) in paragraph (2), in the matter pre-
ceding subparagraph (A), by inserting ‘‘strategy 
and’’ before ‘‘plan’’; and 
(3) in subsection (f)— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by inserting ‘‘, includ-
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