783 
clause (iii) and other information, data, 
and records relevant to the audit to such 
auditor within 6 months of the initiation of 
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 
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such pharmacy benefit manager, that such 
pharmacy benefit manager or affiliate re-
imburse the PDP sponsor for any civil 
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 
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785 
basis, alleged violations of paragraph (1)(A) or 
subparagraph (C). 
‘‘(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— 
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‘‘(A) prohibiting flat dispensing fees or re-
imbursement or payment for ingredient costs 
(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, 
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787 
or a pharmacy under this subsection that is not 
otherwise publicly available or available for pur-
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 
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788 
(section 406 of title 5, United States 
Code), and other applicable statutes. 
‘‘(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— 
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789 
‘‘(i) owns or is owned by, controls or 
is controlled by, or is otherwise related in 
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— 
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790 
‘‘(i) drug price, such as wholesale ac-
quisition cost or drug benchmark price 
(such as average wholesale price); 
‘‘(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-
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791 
essing of drug prior authorization requests, the 
adjudication of appeals or grievances related to 
the prescription drug benefit, contracting with 
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)), as 
amended by section 6223(d)(2), is amended by add-
ing at the end the following new subparagraph: 
‘‘(G) 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 
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792 
Centers for Medicare & Medicaid Services Pro-
gram Management Account, out of any money 
in the Treasury not otherwise appropriated, 
$113,000,000 for fiscal year 2026, 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 2026, 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-
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793 
perts, to the extent available, with respect to the fol-
lowing: 
(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– 
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794 
PD plans regarding pharmacy bene-
fits; or 
(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-
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795 
scription drug price-related compensation struc-
tures, such as the potential for fees or other 
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. 
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796 
(G) Other issues determined to be relevant 
and appropriate by the Comptroller General. 
(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, 
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797 
and other figures for the types of informa-
tion submitted; 
(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 2026, to remain available 
until expended, to carry out this subsection. 
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798 
SEC. 6225. 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, 2028, 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 National Provider Identifier 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 
status attestation that such department is 
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799 
compliant with the requirements described 
in section 413.65 of title 42, Code of Fed-
eral Regulations (or a successor regula-
tion), which, until the Secretary establishes 
the process described in subparagraph (B), 
may include an attestation submitted in 
accordance with paragraph (b)(3) of such 
section (as in effect on the date of enact-
ment of this paragraph); 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.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall, through notice and comment rule-
making, establish a process for each pro-
vider with an off-campus outpatient de-
partment of a provider to submit an initial 
and subsequent attestation pursuant to 
clauses (ii) and (iii), respectively, of sub-
paragraph (A), and for the Secretary to re-
view each such attestation and determine, 
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800 
through site visits, remote audits, or other 
means (as determined appropriate by the 
Secretary), whether such department is 
compliant with the requirements described 
in such subparagraph. 
‘‘(ii) 
FUNDING.—In 
addition 
to 
amounts otherwise available, there is ap-
propriated to the Centers for Medicare & 
Medicaid Services Program Management 
Account for fiscal year 2026, out of any 
amounts in the Treasury not otherwise ap-
propriated, $20,000,000, to remain avail-
able until expended, for purposes of car-
rying out this subparagraph. 
‘‘(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 
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801 
‘‘(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. 
SEC. 6226. REVISING PHASE-IN OF MEDICARE CLINICAL 
LABORATORY TEST PAYMENT CHANGES. 
(a) REVISED PHASE-IN OF REDUCTIONS FROM PRI-
VATE
PAYOR
RATE
IMPLEMENTATION.—Section 
1834A(b)(3) of the Social Security Act (42 U.S.C. 
1395m–1(b)(3)) is amended— 
(1) in subparagraph (A), by striking ‘‘2028’’ 
and inserting ‘‘2029’’; and 
(2) in subparagraph (B)— 
(A) in clause (ii), by striking ‘‘2025 and 
for the period beginning on January 1, 2026, 
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802 
and ending on January 30, 2026’’ and inserting 
‘‘2026’’; and 
(B) in clause (iii), by striking ‘‘the period 
beginning on January 31, 2026, and ending on 
December 31, 2026, and for each of 2027 and 
2028’’ and inserting ‘‘each of 2027 through 
2029’’. 
(b) REVISED DATA COLLECTION PERIOD FOR RE-
PORTING OF PRIVATE SECTOR PAYMENT RATES FOR ES-
TABLISHMENT OF MEDICARE PAYMENT RATES.—Section 
1834A(a)(4)(B) of the Social Security Act (42 U.S.C. 
1395m–1(a)(4)(B)) is amended by striking ‘‘2019’’ each 
place it appears and inserting ‘‘2025’’ in each such place. 
(c) REVISED REPORTING PERIOD FOR REPORTING 
OF PRIVATE SECTOR PAYMENT RATES FOR ESTABLISH-
MENT
OF
MEDICARE
PAYMENT
RATES.—Section 
1834A(a)(1)(B) of the Social Security Act (42 U.S.C. 
1395m–1(a)(1)(B)) is amended— 
(1) in clause (i), by striking ‘‘January 31’’ and 
inserting ‘‘April 30’’; and 
(2) in clause (ii), by striking ‘‘February 1, 
2026, and ending April 30, 2026’’ and inserting 
‘‘May 1, 2026, and ending July 31, 2026’’. 
(d) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human 
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803 
Services may implement the amendments made by this 
section by program instruction or otherwise. 
SEC. 6227. 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 for such 
fiscal year.’’; 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 5 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 7 months in 
which such order is effective for such fiscal 
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804 
year, the payment reduction shall be 0 per-
cent.’’. 
SEC. 6228. MEDICARE IMPROVEMENT FUND. 
Section 1898(b)(1) of the Social Security Act (42 
U.S.C. 
1395iii(b)(1)) 
is 
amended 
by 
striking 
‘‘$1,403,000,000’’ and inserting ‘‘$2,062,000,000’’. 
TITLE III—HUMAN SERVICES 
SEC. 6301. 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 ‘‘2025, and for the pe-
riod beginning on October 1, 2025, and 
ending on January 30, 2026’’ and insert-
ing ‘‘2026, and for the period beginning on 
October 1, 2026, and ending on December 
31, 2026’’; and 
(ii) by striking ‘‘fiscal year 2026’’ and 
inserting ‘‘fiscal year 2027’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘through 2025’’ 
and inserting ‘‘through 2026’’; and 
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(II) by striking ‘‘fiscal year 
2026’’ each place it appears and in-
serting ‘‘fiscal year 2027’’; and 
(ii) in subparagraph (B)(i), by strik-
ing ‘‘2026’’ and inserting ‘‘2027’’; and 
(2) in subsection (f)(1) by striking ‘‘2025, and 
for the period beginning on October 1, 2025, and 
ending on January 30, 2026, an amount equal to 
the pro rata portion of the amount appropriated for 
the corresponding period for fiscal year 2025’’ and 
inserting ‘‘2026, and for the period beginning on Oc-
tober 1, 2026, and ending on December 31, 2026, 
an amount equal to the pro rata portion of the 
amount appropriated for the corresponding period 
for fiscal year 2026’’. 
SEC. 6302. 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), by striking ‘‘2025, and for 
the period beginning on October 1, 2025, and 
ending on January 30, 2026’’ and inserting 
‘‘2026, and for the period beginning on October 
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1, 2026, and ending on December 31, 2026’’; 
and 
(B) in subparagraph (B)(i), by striking 
‘‘fiscal years 2024 and 2025, and for the period 
beginning on October 1, 2025, and ending on 
January 30, 2026’’ and inserting ‘‘fiscal years 
2025 and 2026, and for the period beginning 
on October 1, 2026, and ending on December 
31, 2026’’; 
(2) in subsection (c)(3), by striking ‘‘2026’’ and 
inserting ‘‘2027’’; and 
(3) in subsection (f), by striking ‘‘2025, and for 
the period beginning on October 1, 2025, and ending 
on January 30, 2026, an amount equal to the pro 
rata portion of the amount appropriated for the cor-
responding period for fiscal year 2025’’ and insert-
ing ‘‘2026, and for the period beginning on October 
1, 2026, and ending on December 31, 2026, an 
amount equal to the pro rata portion of the amount 
appropriated for the corresponding period for fiscal 
year 2026’’. 
SEC. 6303. EXTENSION OF FUNDING FOR FAMILY-TO-FAM-
ILY HEALTH INFORMATION CENTERS. 
Section 501(c)(1)(A) of the Social Security Act (42 
U.S.C. 701(c)(1)(A)) is amended— 
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(1) in clause (viii), by striking ‘‘for fiscal year 
2025’’ and inserting ‘‘for each of fiscal years 2025 
and 2026’’; and 
(2) in clause (ix), by striking ‘‘October 1, 2025, 
and ending on January 30, 2026, an amount equal 
to the pro rata portion of the amount appropriated 
for fiscal year 2025’’ and inserting ‘‘October 1, 
2026, and ending on December 31, 2026, an amount 
equal to the pro rata portion of the amount appro-
priated for fiscal year 2026’’. 
SEC. 6304. EXTENSION OF THE TEMPORARY ASSISTANCE 
FOR NEEDY FAMILIES PROGRAM. 
Activities authorized by part A of title IV of the So-
cial Security Act (other than under section 403(c) or 418 
of such Act) and section 1108(b) of the Social Security 
Act shall continue through December 31, 2026, in the 
manner authorized for fiscal year 2025, and out of any 
money in the Treasury of the United States not otherwise 
appropriated, there are hereby appropriated such sums as 
may be necessary for such purpose. 
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TITLE IV—PUBLIC HEALTH AND 
OTHER EXTENDERS 
Subtitle A—Extensions 
SEC. 6401. 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 amended 
by striking subparagraphs (H), (I), (J), and (K) and in-
serting the following: 
‘‘(H) $4,236,712,328 for fiscal year 2024; 
‘‘(I) $4,295,287,671 for fiscal year 2025; 
‘‘(J) $4,600,000,000 for fiscal year 2026; 
and 
‘‘(K) $1,159,452,055 for the period begin-
ning on October 1, 2026, and ending on De-
cember 31, 2026; and’’. 
(b) EXTENSION FOR THE NATIONAL HEALTH SERV-
ICE CORPS.—Section 10503(b)(2) of the Patient Protec-
tion and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) 
is amended by striking subparagraphs (I), (J), (K), and 
(L) and inserting the following: 
‘‘(I) $341,208,605 for fiscal year 2024; 
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‘‘(J) $349,736,600 for fiscal year 2025; 
‘‘(K) $350,000,000 for fiscal year 2026; 
and 
‘‘(L) $88,219,178 for the period beginning 
on October 1, 2026, and ending on December 
31, 2026.’’. 
(c) TEACHING HEALTH CENTERS THAT OPERATE 
GRADUATE MEDICAL EDUCATION PROGRAMS.—Section 
340H(g)(1) of the Public Health Service Act (42 U.S.C. 
256h(g)(1)) is amended by striking subparagraphs (D), 
(E), (F), and (G) and inserting the following: ‘‘ 
‘‘(D) $168,915,878 for fiscal year 2024; 
‘‘(E) $181,563,574 for fiscal year 2025; 
‘‘(F) $225,000,000 for fiscal year 2026; 
‘‘(G) $250,000,000 for fiscal year 2027; 
‘‘(H) $275,000,000 for fiscal year 2028; 
and 
‘‘(I) $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 118–47 for funds for programs authorized under sec-
tions 330 through 340 of the Public Health Service Act 
(42 U.S.C. 254b et seq.). 
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(e) 
CONFORMING
AMENDMENTS.—Section 
3014(h)(4) of title 18, United States Code, is amended 
by striking ‘‘and section 6101(d) of the Continuing Appro-
priations, Agriculture, Legislative Branch, Military Con-
struction and Veterans Affairs, and Extensions Act, 
2026’’ and inserting ‘‘section 6101(d) of the Continuing 
Appropriations, Agriculture, Legislative Branch, Military 
Construction and Veterans Affairs, and Extensions Act, 
2026, and section 6401(d) of the Consolidated Appropria-
tions Act, 2026’’. 
SEC. 6402. 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 by striking subparagraphs (E), (F), (G), and (H) and 
inserting the following: 
‘‘(E) $155,619,196 for fiscal year 2024, to 
remain available until expended; 
‘‘(F) $159,228,188 for fiscal year 2025, to 
remain available until expended; 
‘‘(G) $200,000,000 for fiscal year 2026, to 
remain available until expended; and 
‘‘(H) $50,410,959 for the period beginning 
on October 1, 2026, and ending on December 
31, 2026, to remain available until expended.’’. 
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(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 by striking subparagraphs (E), (F), (G), and 
(H) and inserting the following: 
‘‘(E) $155,619,196 for fiscal year 2024, to 
remain available until expended; 
‘‘(F) $159,228,188 for fiscal year 2025, to 
remain available until expended; 
‘‘(G) $200,000,000 for fiscal year 2026, to 
remain available until expended; and 
‘‘(H) $50,410,959 for the period beginning 
on October 1, 2026, and ending on December 
31, 2026, to remain available until expended.’’. 
SEC. 6403. EXTENSION OF NATIONAL HEALTH SECURITY 
PROGRAMS. 
(a) Section 319(e)(8) of the Public Health Service 
Act (42 U.S.C. 247d(e)(8)) is amended by striking ‘‘Janu-
ary 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(b) Section 319L(e)(1)(D) of the Public Health Serv-
ice Act (42 U.S.C. 247d–7e(e)(1)(D)) is amended by strik-
ing ‘‘January 30, 2026’’ and inserting ‘‘December 31, 
2026’’. 
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(c) Section 319L–1(b) of the Public Health Service 
Act (42 U.S.C. 247d–7f(b)) is amended by striking ‘‘Jan-
uary 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(d) Section 2811A(g) of the Public Health Service 
Act (42 U.S.C. 300hh–10b(g)) is amended by striking 
‘‘January 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(e) Section 2811B(g)(1) of the Public Health Service 
Act (42 U.S.C. 300hh–10c(g)(1)) is amended by striking 
‘‘January 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(f) Section 2811C(g)(1) of the Public Health Service 
Act (42 U.S.C. 300hh–10d(g)(1)) is amended by striking 
‘‘January 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(g) Section 2812(c)(4)(B) of the Public Health Serv-
ice Act (42 U.S.C. 300hh–11(c)(4)(B)) is amended by 
striking ‘‘January 30, 2026’’ and inserting ‘‘December 31, 
2026’’. 
SEC. 6404. NO SURPRISES ACT IMPLEMENTATION. 
Section 118(a) of division BB of the Consolidated 
Appropriations Act, 2021 (Public Law 116–260) is 
amended— 
(1) in paragraph (1), by striking ‘‘January 30, 
2026’’ and inserting ‘‘December 31, 2026’’; and 
(2) in paragraph (2)— 
(A) by striking ‘‘$14,000,000’’ and insert-
ing ‘‘$42,100,000’’; and 
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(B) by striking ‘‘January 30, 2026’’ and 
inserting ‘‘December 31, 2026’’. 
Subtitle B—World Trade Center 
Health Program 
SEC. 6411. 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 1.07; 
multiplied by 
‘‘(II) the ratio of— 
‘‘(aa) the total number of 
individuals enrolled in the AC 
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 the 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); and 
(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 XXIII 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—PUBLIC HEALTH 
PROGRAMS 
SEC. 6501. PREVENTING MATERNAL DEATHS. 
(a) MATERNAL MORTALITY REVIEW COMMITTEES.— 
Section 317K(d) of the Public Health Service Act (42 
U.S.C. 247b–12(d)) is amended— 
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(1) in paragraph (1)(A), by inserting ‘‘(includ-
ing obstetricians and gynecologists)’’ after ‘‘clinical 
specialties’’; and 
(2) in paragraph (3)(A)(i)— 
(A) in subclause (I), by striking ‘‘as appli-
cable’’ and inserting ‘‘if available’’; and 
(B) in subclause (III), by striking ‘‘, as ap-
propriate’’ and inserting ‘‘and coordinating with 
individuals responsible for certifying deaths to 
improve the collection and quality of death 
record reports, including by amending errors 
and missing or incomplete information to cause- 
of-death information on a death certificate, as 
appropriate’’. 
(b) MATERNAL MORTALITY.—Section 317K of the 
Public Health Service Act (42 U.S.C. 247b–12) is amend-
ed— 
(1) by redesignating subsections (e) and (f) as 
subsections (f) and (g), respectively; and 
(2) by inserting after subsection (d) the fol-
lowing: 
‘‘(e) BEST PRACTICES RELATING TO THE PREVEN-
TION OF MATERNAL MORTALITY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
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Control and Prevention, shall, in consultation with 
the Administrator of the Health Resources and Serv-
ices Administration, identify and disseminate to 
health care providers, relevant professional societies, 
and perinatal quality collaboratives, best practices 
related to preventing maternal morbidity and mor-
tality, taking into consideration any relevant find-
ings from other Federal maternal health programs. 
‘‘(2) 
FREQUENCY.—The 
Secretary, 
acting 
through the Director of the Centers for Disease 
Control and Prevention, shall disseminate the best 
practices referred to in paragraph (1) not less than 
once per fiscal year.’’. 
(c) AUTHORIZATION
OF
APPROPRIATIONS.—Sub-
section (g) of section 317K of the Public Health Service 
Act (42 U.S.C. 247b–12), as redesignated by subsection 
(b)(1), is amended by striking ‘‘$58,000,000 for each of 
fiscal 
years 
2019 
through 
2023’’ 
and 
inserting 
‘‘$100,000,000 for each of fiscal years 2026 through 
2030’’. 
SEC. 6502. ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK. 
Section 372 of the Public Health Service Act (42 
U.S.C. 274) is amended— 
(1) in subsection (b)(2)— 
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(A) by moving the margins of subpara-
graphs (M) through (O) 2 ems to the left; 
(B) in subparagraph (A)— 
(i) in clause (i), by striking ‘‘, and’’ 
and inserting ‘‘; and’’; and 
(ii) in clause (ii), by striking the 
comma at the end and inserting a semi-
colon; 
(C) in subparagraph (C), by striking 
‘‘twenty-four-hour telephone service’’ and in-
serting ‘‘24-hour telephone or information tech-
nology service’’; 
(D) in each of subparagraphs (B) through 
(M), by striking the comma at the end and in-
serting a semicolon; 
(E) in subparagraph (N), by striking 
‘‘transportation, and’’ and inserting ‘‘transpor-
tation;’’; 
(F) in subparagraph (O), by striking the 
period and inserting a semicolon; and 
(G) by adding at the end the following: 
‘‘(P) encourage the integration of electronic 
health records systems through application program-
ming interfaces (or successor technologies) among 
hospitals, organ procurement organizations, and 
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transplant centers, including the use of automated 
electronic hospital referrals and the grant of remote, 
electronic access to hospital electronic health records 
of potential donors by organ procurement organiza-
tions, in a manner that complies with the privacy 
regulations promulgated under the Health Insurance 
Portability and Accountability Act of 1996, at part 
160 of title 45, Code of Federal Regulations, and 
subparts A, C, and E of part 164 of such title (or 
any successor regulations); and 
‘‘(Q) consider establishing a dashboard to dis-
play the number of transplants performed, the types 
of transplants performed, the number and types of 
organs that entered the Organ Procurement and 
Transplantation Network system and failed to be 
transplanted, and other appropriate statistics, which 
should be updated more frequently than annually.’’; 
and 
(2) by adding at the end the following: 
‘‘(d) REGISTRATION FEES.— 
‘‘(1) IN GENERAL.—The Secretary may collect 
registration fees from any member of the Organ 
Procurement and Transplantation Network for each 
transplant candidate such member places on the list 
described in subsection (b)(2)(A)(i). Such registra-
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tion fees shall be collected and distributed only to 
support the operation of the Organ Procurement 
and Transplantation Network. Such registration fees 
are authorized to remain available until expended. 
‘‘(2) COLLECTION.—The Secretary may collect 
the registration fees under paragraph (1) directly or 
through awards made under subsection (b)(1)(A). 
‘‘(3) DISTRIBUTION.—Any amounts collected 
under this subsection shall— 
‘‘(A) be credited to the currently applicable 
appropriation, account, or fund of the Depart-
ment of Health and Human Services as discre-
tionary offsetting collections; and 
‘‘(B) be available, only to the extent and in 
the amounts provided in advance in appropria-
tions Acts, to distribute such fees among 
awardees described in subsection (b)(1)(A). 
‘‘(4) TRANSPARENCY.—The Secretary shall— 
‘‘(A) promptly post on the website of the 
Organ Procurement and Transplantation Net-
work— 
‘‘(i) the amount of registration fees 
collected under this subsection from each 
member of the Organ Procurement and 
Transplantation Network; and 
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‘‘(ii) a list of activities such fees are 
used to support; and 
‘‘(B) update the information posted pursu-
ant to subparagraph (A), as applicable for each 
calendar quarter for which fees are collected 
under paragraph (1). 
‘‘(5) GAO REVIEW.—Not later than 2 years 
after the date of enactment of this subsection, the 
Comptroller General of the United States shall, to 
the extent data are available— 
‘‘(A) conduct a review concerning the ac-
tivities under this subsection; and 
‘‘(B) submit to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Finance of the Senate and the Com-
mittee on Energy and Commerce of the House 
of Representatives, a report on such review, in-
cluding related recommendations, as applicable. 
‘‘(6) SUNSET.—The authority to collect reg-
istration fees under paragraph (1) shall expire on 
the date that is 3 years after the date of enactment 
of the Consolidated Appropriations Act, 2026.’’. 
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SEC. 6503. HONOR OUR LIVING DONORS. 
(a) NO CONSIDERATION OF INCOME OF ORGAN RE-
CIPIENT.—Section 377 of the Public Health Service Act 
(42 U.S.C. 274f) is amended— 
(1) by redesignating subsections (c) through (f) 
as subsections (d) through (g), respectively; 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) NO CONSIDERATION OF INCOME OF ORGAN RE-
CIPIENT.—The recipient of a grant under this section, in 
providing reimbursement to a donating individual through 
such grant, shall not give any consideration to the income 
of the organ recipient.’’; and 
(3) in subsection (f), as so redesignated— 
(A) in paragraph (1), by striking ‘‘sub-
section 
(c)(1)’’ 
and 
inserting 
‘‘subsection 
(d)(1)’’; and 
(B) in paragraph (2), by striking ‘‘sub-
section 
(c)(2)’’ 
and 
inserting 
‘‘subsection 
(d)(2)’’. 
(b) REMOVAL OF EXPECTATION OF PAYMENTS BY 
ORGAN
RECIPIENTS.—Section 377(e) of the Public 
Health Service Act (42 U.S.C. 274f(e)), as redesignated 
by subsection (a)(1), is amended— 
(1) in paragraph (1), by adding ‘‘or’’ at the 
end; 
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(2) in paragraph (2), by striking ‘‘; or’’ and in-
serting a period; and 
(3) by striking paragraph (3). 
(c) ANNUAL REPORT.—Section 377 of the Public 
Health Service Act (42 U.S.C. 274f), as amended by sub-
sections (a) and (b), is amended by adding at the end the 
following: 
‘‘(h) ANNUAL REPORT.—Not later than December 31 
of each year, beginning in fiscal year 2027, the Secretary 
shall— 
‘‘(1) prepare, submit to the Congress, and make 
public a report on whether grants under this section 
provided adequate funding during the preceding fis-
cal year to reimburse all donating individuals par-
ticipating in the grant program under this section 
for all qualifying expenses; and 
‘‘(2) include in each such report— 
‘‘(A) the estimated number of all donating 
individuals participating in the grant program 
under this section who did not receive reim-
bursement for all qualifying expenses during 
the preceding fiscal year; and 
‘‘(B) the total amount of funding that is 
estimated to be necessary to fully reimburse all 
donating individuals participating in the grant 
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program under this section for all qualifying ex-
penses.’’. 
SEC. 6504. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
Section 409I(d)(1) of the Public Health Service Act 
(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘section,’’ 
and all that follows through the period at the end and 
inserting ‘‘section, $25,000,000 for each of fiscal years 
2026 through 2028.’’. 
SEC. 6505. SICKLE CELL DISEASE PREVENTION AND TREAT-
MENT. 
(a) IN GENERAL.—Section 1106(b) of the Public 
Health Service Act (42 U.S.C. 300b–5(b)) is amended— 
(1) in paragraph (1)(A)(iii), by striking ‘‘pre-
vention and treatment of sickle cell disease’’ and in-
serting ‘‘treatment of sickle cell disease and the pre-
vention and treatment of complications of sickle cell 
disease’’; 
(2) in paragraph (2)(D), by striking ‘‘preven-
tion and treatment of sickle cell disease’’ and insert-
ing ‘‘treatment of sickle cell disease and the preven-
tion and treatment of complications of sickle cell dis-
ease’’; 
(3) in paragraph (3)— 
(A) in subparagraph (A), by striking 
‘‘enter into a contract with’’ and inserting 
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‘‘make a grant to, or enter into a contract or 
cooperative agreement with,’’; and 
(B) in subparagraph (B), in each of 
clauses (ii) and (iii), by striking ‘‘prevention 
and treatment of sickle cell disease’’ and insert-
ing ‘‘treatment of sickle cell disease and the 
prevention and treatment of complications of 
sickle cell disease’’; and 
(4) in paragraph (6), by striking ‘‘$4,455,000 
for each of fiscal years 2019 through 2023’’ and in-
serting ‘‘$8,205,000 for each of fiscal years 2026 
through 2030’’. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that further research should be undertaken to ex-
pand the understanding of the causes of, and to find cures 
for, heritable blood disorders, including sickle cell disease. 
SEC. 6506. LIFESPAN RESPITE CARE. 
(a) DEFINITION OF FAMILY CAREGIVER.—Section 
2901(5) of the Public Health Service Act (42 U.S.C. 
300ii(5)) is amended by striking ‘‘unpaid adult’’ and in-
serting ‘‘unpaid individual’’. 
(b) FUNDING.—Section 2905 of the Public Health 
Service Act (42 U.S.C. 300ii–4) is amended by striking 
‘‘fiscal years 2020 through fiscal year 2024’’ and inserting 
‘‘fiscal years 2026 through 2030’’. 
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SEC. 6507. PREEMIE. 
(a) RESEARCH RELATING TO PRETERM LABOR AND 
DELIVERY AND THE CARE, TREATMENT, AND OUTCOMES 
OF PRETERM AND LOW BIRTHWEIGHT INFANTS.— 
(1) IN
GENERAL.—Section 3(e) of the Pre-
maturity Research Expansion and Education for 
Mothers who deliver Infants Early Act (42 U.S.C. 
247b–4f(e)) is amended by striking ‘‘fiscal years 
2019 through 2023’’ and inserting ‘‘fiscal years 
2026 through 2030’’. 
(2) TECHNICAL CORRECTION.—Effective as if 
included in the enactment of the PREEMIE Reau-
thorization Act of 2018 (Public Law 115–328), sec-
tion 2 of such Act is amended, in the matter pre-
ceding paragraph (1), by striking ‘‘Section 2’’ and 
inserting ‘‘Section 3’’. 
(b) INTERAGENCY WORKING GROUP.—Section 5(a) 
of the PREEMIE Reauthorization Act of 2018 (Public 
Law 115–328) is amended by striking ‘‘The Secretary of 
Health and Human Services, in collaboration with other 
departments, as appropriate, may establish’’ and inserting 
‘‘Not later than 18 months after the date of the enactment 
of the Consolidated Appropriations Act, 2026, the Sec-
retary of Health and Human Services, in collaboration 
with other departments, as appropriate, shall establish’’. 
(c) STUDY ON PRETERM BIRTHS.— 
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(1) IN GENERAL.—The Secretary of Health and 
Human Services shall enter into appropriate ar-
rangements 
with 
the 
National 
Academies 
of 
Sciences, Engineering, and Medicine under which 
the National Academies shall— 
(A) not later than 30 days after the date 
of enactment of this Act, convene a committee 
of experts in maternal health to study pre-
mature births in the United States; and 
(B) upon completion of the study under 
subparagraph (A)— 
(i) approve by consensus a report on 
the results of such study; 
(ii) include in such report— 
(I) an assessment of each of the 
topics listed in paragraph (2); 
(II) the analysis required by 
paragraph (3); and 
(III) the raw data used to de-
velop such report; and 
(iii) not later than 24 months after 
the date of enactment of this Act, transmit 
such report to— 
(I) the Secretary of Health and 
Human Services; 
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(II) the Committee on Energy 
and Commerce of the House of Rep-
resentatives; and 
(III) the Committee on Finance 
and the Committee on Health, Edu-
cation, Labor, and Pensions of the 
Senate. 
(2) ASSESSMENT TOPICS.—The topics listed in 
this subsection are each of the following: 
(A) The financial costs of premature birth 
to society, including— 
(i) an analysis of stays in neonatal in-
tensive care units and the cost of such 
stays; 
(ii) long-term costs of stays in such 
units to society and the family involved 
post-discharge; and 
(iii) health care costs for families 
post-discharge from such units (such as 
medications, therapeutic services, co-pay-
ments for visits, and specialty equipment). 
(B) The factors that impact preterm birth 
rates. 
(C) Opportunities for earlier detection of 
premature birth risk factors, including— 
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830 
(i) opportunities to improve maternal 
and infant health; and 
(ii) opportunities for public health 
programs to provide support and resources 
for parents in-hospital, in non-hospital set-
tings, and post-discharge. 
(3) ANALYSIS.—The analysis required by this 
subsection is an analysis of— 
(A) targeted research strategies to develop 
effective drugs, treatments, or interventions to 
bring at-risk pregnancies to term; 
(B) State and other programs’ best prac-
tices with respect to reducing premature birth 
rates; and 
(C) precision medicine and preventative 
care approaches starting early in the life course 
(including during pregnancy) with a focus on 
behavioral and biological influences on pre-
mature birth, child health, and the trajectory of 
such approaches into adulthood. 
SEC. 6508. DR. LORNA BREEN HEALTH CARE PROVIDER 
PROTECTION. 
(a) DISSEMINATION OF BEST PRACTICES.—Section 
2 of the Dr. Lorna Breen Health Care Provider Protection 
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831 
Act (Public Law 117–105) is amended by striking ‘‘2 
years’’ and inserting ‘‘5 years’’. 
(b) EDUCATION AND AWARENESS INITIATIVE EN-
COURAGING USE OF MENTAL HEALTH AND SUBSTANCE 
USE DISORDER SERVICES BY HEALTH CARE PROFES-
SIONALS.—Section 3 of the Dr. Lorna Breen Health Care 
Provider Protection Act (Public Law 117–105) is amend-
ed— 
(1) in subsection (b), by inserting ‘‘and annu-
ally thereafter,’’ after ‘‘of this Act,’’; and 
(2) in subsection (c), by striking ‘‘2022 through 
2024’’ and inserting ‘‘2026 through 2030’’. 
(c) PROGRAMS
TO
PROMOTE
MENTAL
HEALTH 
AMONG THE HEALTH PROFESSIONAL WORKFORCE.—The 
second section 764 of the Public Health Service Act (42 
U.S.C. 294t), as added by section 4 of the Dr. Lorna 
Breen Health Care Provider Protection Act (Public Law 
117–105), is amended— 
(1) by redesignating such section 764 as section 
764A; 
(2) in subsection (a)(3)— 
(A) by striking ‘‘to eligible entities in’’ and 
inserting ‘‘to eligible entities that— 
‘‘(A) are in’’; 
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832 
(B) by striking the period and inserting ‘‘; 
or’’; and 
(C) by adding at the end the following: 
‘‘(B) have a focus on the reduction of ad-
ministrative burden on health care workers.’’; 
(3) in subsection (c), by inserting ‘‘not less 
than’’ after ‘‘period of’’; and 
(4) in subsection (f), by striking ‘‘2022 through 
2024’’ and inserting ‘‘2026 through 2030’’. 
TITLE VI—FOOD AND DRUG 
ADMINISTRATION 
Subtitle A—Mikaela Naylon Give 
Kids a Chance Act 
SEC. 6601. RESEARCH INTO PEDIATRIC USES OF DRUGS; 
ADDITIONAL AUTHORITIES OF FOOD AND 
DRUG ADMINISTRATION REGARDING MOLEC-
ULARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
(1) ADDITIONAL ACTIVE INGREDIENT FOR AP-
PLICATION DRUG; LIMITATION REGARDING NOVEL- 
COMBINATION
APPLICATION
DRUG.—Section 
505B(a)(3) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(3)) is amended— 
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(A) by redesignating subparagraphs (B) 
and (C) as subparagraphs (C) and (D), respec-
tively; and 
(B) by striking subparagraph (A) and in-
serting the following: 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the investigation described in this 
paragraph is a molecularly targeted pediatric 
cancer investigation of— 
‘‘(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or 
‘‘(ii) such drug or biological product 
used in combination with— 
‘‘(I) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(j) 
under this Act or under section 
351(k) of the Public Health 
Service Act is in effect; and 
‘‘(bb) that is determined by 
the Secretary, after consultation 
with the applicant, to be part of 
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834 
the standard of care for treating 
a pediatric cancer; or 
‘‘(II) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(b) 
of this Act or section 351(a) of 
the Public Health Service Act to 
treat an adult cancer is in effect 
and is held by the same person 
submitting the application under 
paragraph (1)(B); and 
‘‘(bb) that is directed at a 
molecular target that the Sec-
retary determines to be substan-
tially relevant to the growth or 
progression of a pediatric cancer. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) DESIGN
OF
INVESTIGATION.—A 
molecularly targeted pediatric cancer inves-
tigation referred to in subparagraph (A) 
shall be designed to yield clinically mean-
ingful pediatric study data that is gathered 
using appropriate formulations for each 
age group for which the study is required, 
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835 
regarding dosing, safety, and preliminary 
efficacy to inform potential pediatric label-
ing. 
‘‘(ii) LIMITATION.—An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological 
product for which the application referred 
to in paragraph (1)(B) contains either— 
‘‘(I) a single new active ingre-
dient; or 
‘‘(II) more than one active ingre-
dient, if an application for the com-
bination of active ingredients has not 
previously been approved but each ac-
tive ingredient is in a drug product 
that has been previously approved to 
treat an adult cancer. 
‘‘(iii) RESULTS
OF
ALREADY-COM-
PLETED PRECLINICAL STUDIES OF APPLI-
CATION DRUG.—With respect to an inves-
tigation required pursuant to paragraph 
(1)(B), the Secretary may require the re-
sults of any completed preclinical studies 
relevant to the initial pediatric study plan 
be submitted to the Secretary at the same 
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836 
time that the initial pediatric study plan 
required under subsection (e)(1) is sub-
mitted. 
‘‘(iv) RULE
OF
CONSTRUCTION
RE-
GARDING
INACTIVE
INGREDIENTS.—With 
respect to a combination of active ingredi-
ents referred to in subparagraph (A)(ii), 
such subparagraph shall not be construed 
as addressing the use of inactive ingredi-
ents with such combination.’’. 
(2) DETERMINATION OF APPLICABLE REQUIRE-
MENTS.—Section 505B(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 
amended by adding at the end the following: ‘‘The 
Secretary shall determine whether subparagraph (A) 
or (B) of subsection (a)(1) applies with respect to an 
application before the date on which the applicant is 
required to submit the initial pediatric study plan 
under paragraph (2)(A).’’. 
(3) 
CLARIFYING
APPLICABILITY.—Section 
505B(a)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(1)) is amended by 
adding at the end the following: 
‘‘(C) RULE OF CONSTRUCTION.—No appli-
cation that is subject to the requirements of 
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837 
subparagraph (B) shall be subject to the re-
quirements of subparagraph (A), and no appli-
cation (or supplement to an application) that is 
subject to the requirements of subparagraph 
(A) shall be subject to the requirements of sub-
paragraph (B).’’. 
(4) 
CONFORMING
AMENDMENTS.—Section 
505B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)) is amended— 
(A) in paragraph (3)(C), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘investigations described in this para-
graph’’ and inserting ‘‘investigations referred to 
in subparagraph (A)’’; and 
(B) in paragraph (3)(D), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘the assessments under paragraph 
(2)(B)’’ and inserting ‘‘the assessments re-
quired under paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall— 
(1) not later than 12 months after the date of 
enactment of this Act, issue draft guidance on the 
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838 
implementation of the amendments made by sub-
section (a); and 
(2) not later than 12 months after closing the 
comment period on such draft guidance, finalize 
such guidance. 
(c) APPLICABILITY.—The amendments made by this 
section apply with respect to any application under section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)) and any application under section 351(a) 
of the Public Health Service Act (42 U.S.C. 262(a)), that 
is submitted on or after the date that is 3 years after the 
date of enactment of this Act. 
(d) REPORTS TO CONGRESS.— 
(1) SECRETARY OF HEALTH AND HUMAN SERV-
ICES.—Not later than 6 years after the date of en-
actment of this Act, the Secretary of Health and 
Human Services shall submit to the Committee on 
Energy and Commerce of the House of Representa-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the 
Secretary’s efforts, in coordination with industry, to 
ensure implementation of the amendments made by 
subsection (a). 
(2) GAO STUDY AND REPORT.— 
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839 
(A) STUDY.—Not later than 8 years after 
the date of enactment of this Act, the Comp-
troller General of the United States shall con-
duct a study of the effectiveness of requiring 
assessments and investigations described in sec-
tion 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C.355c), as amended by sub-
section (a), in the development of drugs and bi-
ological products for pediatric cancer indica-
tions, including consideration of any benefits to, 
or burdens on, pediatric cancer drug develop-
ment. 
(B) FINDINGS.—Not later than 10 years 
after the date of enactment of this Act, the 
Comptroller General shall submit to the Com-
mittee on Energy and Commerce of the House 
of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the 
Senate a report containing the findings of the 
study conducted under subparagraph (A). 
SEC. 6602. ENSURING COMPLETION OF PEDIATRIC STUDY 
REQUIREMENTS. 
(a) EQUAL ACCOUNTABILITY FOR PEDIATRIC STUDY 
REQUIREMENTS.—Section 505B(d) of the Federal Food, 
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840 
Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amend-
ed— 
(1) in paragraph (1), by striking ‘‘Beginning 
270’’ and inserting ‘‘NONCOMPLIANCE
LETTER.— 
Beginning 270’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘The drug or’’ and insert-
ing ‘‘EFFECT OF NONCOMPLIANCE.—The drug 
or’’; and 
(B) by striking ‘‘(except that the drug or 
biological product shall not be subject to action 
under section 303)’’ and inserting ‘‘(except that 
the drug or biological product shall be subject 
to action under section 303 only if such person 
demonstrated a lack of due diligence in satis-
fying the applicable requirement)’’; and 
(3) by adding at the end the following: 
‘‘(3) LIMITATION.—The Secretary shall not 
issue enforcement actions under section 303 for fail-
ures under this subsection in the case of a drug or 
biological product that is no longer marketed.’’. 
(b) DUE DILIGENCE.—Section 505B(d) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), 
as amended by subsection (a), is further amended by add-
ing at the end the following: 
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841 
‘‘(4) DUE
DILIGENCE.—Before the Secretary 
may conclude that a person failed to submit or oth-
erwise meet a requirement as described in the mat-
ter preceding paragraph (1), the Secretary shall— 
‘‘(A) issue a noncompliance letter pursuant 
to paragraph (1); 
‘‘(B) provide such person with a 45-day 
period beginning on the date of receipt of such 
noncompliance letter to respond in writing as 
set forth in such paragraph; and 
‘‘(C) after reviewing such written response, 
determine whether the person demonstrated a 
lack of due diligence in satisfying such require-
ment.’’. 
(c) 
CONFORMING
AMENDMENTS.—Section 
303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333(f)(4)(A)) is amended by striking ‘‘or 505– 
1’’ and inserting ‘‘505–1, or 505B’’. 
(d) TRANSITION RULE.—The Secretary of Health 
and Human Services may take enforcement action under 
section 303 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333) only for failures described in section 
505B(d) of such Act (21 U.S.C. 355c(d)) that occur on 
or after the date that is 180 days after the date of enact-
ment of this Act. 
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842 
SEC. 6603. FDA REPORT ON PREA ENFORCEMENT. 
Section 508(b) of the Food and Drug Administration 
Safety and Innovation Act (21 U.S.C. 355c–1(b)) is 
amended— 
(1) in paragraph (11), by striking the semicolon 
at the end and inserting ‘‘, including an evaluation 
of compliance with deadlines provided for in defer-
rals and deferral extensions;’’; 
(2) in paragraph (15), by striking ‘‘and’’ at the 
end; 
(3) in paragraph (16), by striking the period at 
the end and inserting ‘‘; and’’; and 
(4) by adding at the end the following: 
‘‘(17) a listing of penalties, settlements, or pay-
ments under section 303 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353) for failure to 
comply with requirements under such section 505B, 
including, for each penalty, settlement, or payment, 
the name of the drug, the sponsor thereof, and the 
amount of the penalty, settlement, or payment im-
posed.’’. 
SEC. 6604. EXTENSION OF AUTHORITY TO ISSUE PRIORITY 
REVIEW VOUCHERS TO ENCOURAGE TREAT-
MENTS FOR RARE PEDIATRIC DISEASES. 
(a) EXTENSION.—Paragraph (5) of section 529(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
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360ff(b)) is amended by striking ‘‘December 20, 2024, un-
less’’ and all that follows through the period at the end 
and inserting ‘‘September 30, 2029.’’. 
(b) USER FEE PAYMENT.—Section 529(c)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(c)(4)) is amended by striking subparagraph (A) and 
inserting the following: 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
upon the submission of a human drug applica-
tion under section 505(b)(1) or section 351(a) 
of the Public Health Service Act for which the 
priority review voucher is used. All other user 
fees associated with the human drug application 
shall be due as required by the Secretary or 
under applicable law.’’. 
(c) GAO REPORT ON EFFECTIVENESS OF RARE PE-
DIATRIC
DISEASE
PRIORITY
VOUCHER
AWARDS
IN 
INCENTIVIZING RARE PEDIATRIC DISEASE DRUG DEVEL-
OPMENT.— 
(1) GAO STUDY.— 
(A) STUDY.—The Comptroller General of 
the United States shall conduct a study of the 
effectiveness of awarding rare pediatric disease 
priority vouchers under section 529 of the Fed-
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eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff), as amended by subsection (a), in the de-
velopment of human drug products that treat or 
prevent rare pediatric diseases (as defined in 
such section 529). 
(B) CONTENTS OF STUDY.—In conducting 
the study under subparagraph (A), the Comp-
troller General shall examine the following: 
(i) The indications for each drug or 
biological product that— 
(I) is the subject of a rare pedi-
atric disease product application (as 
defined in section 529 of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 360ff)) for which a priority re-
view voucher was awarded; and 
(II) was approved under section 
505 of the Federal Food, Drug, and 
Cosmetic Act (42 U.S.C. 355) or li-
censed under section 351 of the Pub-
lic Health Service Act (42 U.S.C. 
262). 
(ii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was 
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met through the approval or licensure of 
such a drug or biological product. 
(iii) The size of the company to which 
a priority review voucher was awarded 
under section 529 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360ff) 
for such a drug or biological product. 
(iv) The value of such priority review 
voucher if transferred. 
(v) Identification of each drug for 
which a priority review voucher awarded 
under such section 529 was used. 
(vi) The size of the company using 
each priority review voucher awarded 
under such section 529. 
(vii) The length of the period of time 
between the date on which a priority re-
view voucher was awarded under such sec-
tion 529 and the date on which it was 
used. 
(viii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was 
met through the approval under section 
505 of the Federal Food, Drug, and Cos-
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846 
metic Act (42 U.S.C. 355) or licensure 
under section 351 of the Public Health 
Service Act (42 U.S.C. 262) of a drug for 
which a priority review voucher was used. 
(ix) Whether, and to what extent, 
companies were motivated by the avail-
ability of priority review vouchers under 
section 529 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360ff) to at-
tempt to develop a drug for a rare pedi-
atric disease. 
(x) Whether, and to what extent, pedi-
atric review vouchers awarded under such 
section were successful in stimulating de-
velopment and expedited patient access to 
drug products for treatment or prevention 
of a rare pediatric disease that wouldn’t 
otherwise take place without the incentive 
provided by such vouchers. 
(xi) The impact of such priority re-
view vouchers on the workload, review 
process, and public health prioritization ef-
forts of the Food and Drug Administra-
tion. 
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847 
(xii) Any other incentives in Federal 
law that exist for companies developing 
drugs or biological products described in 
clause (i). 
(2) REPORT ON FINDINGS.—Not later than 5 
years after the date of the enactment of this Act, the 
Comptroller General of the United States shall sub-
mit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a report containing the findings of the study 
conducted under paragraph (1). 
SEC. 6605. LIMITATIONS ON EXCLUSIVE APPROVAL OR LI-
CENSURE OF ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
tion’’ and inserting ‘‘same approved use or indica-
tion within such rare disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ 
and inserting ‘‘same approved use or indication 
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848 
for which such 7-year period applies to such al-
ready approved or licensed drug’’; and 
(B) in paragraph (1), by inserting ‘‘, relat-
ing to the approved use or indication,’’ after 
‘‘the needs’’; 
(3) in subsection (c)(1), by striking ‘‘same rare 
disease or condition as the already approved drug’’ 
and inserting ‘‘same use or indication for which the 
already approved or licensed drug was approved or 
licensed’’; and 
(4) by adding at the end the following: 
‘‘(f) APPROVED USE OR INDICATION DEFINED.—In 
this section, the term ‘approved use or indication’ means 
the use or indication approved under section 505 of this 
Act or licensed under section 351 of the Public Health 
Service Act for a drug designated under section 526 for 
a rare disease or condition.’’. 
(b) APPLICATION OF AMENDMENTS.—The amend-
ments made by subsection (a) shall apply with respect to 
any drug designated under section 526 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-
less of the date on which the drug was so designated, and 
regardless of the date on which the drug was approved 
under section 505 of such Act (21 U.S.C. 355) or licensed 
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849 
under section 351 of the Public Health Service Act (42 
U.S.C. 262). 
Subtitle B—United States-Abraham 
Accords Cooperation and Security 
SEC. 6611. ESTABLISHMENT OF ABRAHAM ACCORDS OF-
FICE WITHIN FOOD AND DRUG ADMINISTRA-
TION. 
(a) IN GENERAL.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall establish with-
in the Food and Drug Administration an office, to be 
known as the Abraham Accords Office, to be headed by 
a director. 
‘‘(b) OFFICE.—Not later than 2 years after the date 
of enactment of this section, the Secretary shall— 
‘‘(1) in consultation with the governments of 
Abraham Accords countries, as well as appropriate 
United States Government diplomatic and security 
personnel— 
‘‘(A) select the location of the Abraham 
Accords Office in an Abraham Accords country; 
and 
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‘‘(B) establish such office; and 
‘‘(2) assign to such office such personnel of the 
Food and Drug Administration as the Secretary de-
termines necessary to carry out the functions of 
such office. 
‘‘(c) DUTIES.—The Secretary, acting through the Di-
rector of the Abraham Accords Office, shall— 
‘‘(1) after the Abraham Accords Office is estab-
lished— 
‘‘(A) as part of the Food and Drug Admin-
istration’s work to strengthen the international 
oversight of regulated commodities, provide 
technical assistance to regulatory partners in 
Abraham Accords countries on strengthening 
regulatory oversight and converging regulatory 
requirements for the oversight of regulated 
products, including good manufacturing prac-
tices and other issues relevant to manufacturing 
medical products that are regulated by the 
Food and Drug Administration; and 
‘‘(B) facilitate interactions between the 
Food and Drug Administration and interested 
parties in Abraham Accords countries, including 
by sharing relevant information regarding 
United States regulatory pathways with such 
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851 
parties, and facilitate feedback on the research, 
development, and manufacturing of products 
regulated in accordance with this Act; and 
‘‘(2) carry out other functions and activities as 
the Secretary determines to be necessary to carry 
out this section. 
‘‘(d) ABRAHAM ACCORDS COUNTRY DEFINED.—In 
this section, the term ‘Abraham Accords country’ means 
a country identified by the Department of State as having 
signed the Abraham Accords Declaration. 
‘‘(e) NATIONAL SECURITY.—Nothing in this section 
shall be construed to require any action inconsistent with 
a national security recommendation provided by the Fed-
eral Government.’’. 
(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 shall submit to the 
Congress a report on the Abraham Accords Office, 
including— 
(A) an evaluation of how the Office has ad-
vanced progress toward conformance with Food 
and Drug Administration regulatory require-
ments by manufacturers in the Abraham Ac-
cords countries; 
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852 
(B) a numerical count of parties that the 
Office has helped facilitate interactions or feed-
back pursuant to section 1015(c)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (as 
added by subsection (a)); 
(C) a summary of technical assistance pro-
vided to regulatory partners in Abraham Ac-
cords countries pursuant to subparagraph (A) 
of such section 1015(c)(1); and 
(D) recommendations for increasing and 
improving coordination between the Food and 
Drug Administration and entities in Abraham 
Accords countries. 
(2) ABRAHAM ACCORDS COUNTRY DEFINED.— 
In this subsection, the term ‘‘Abraham Accords 
country’’ has the meaning given such term in section 
1015(d) of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a)). 
TITLE VII—LOWERING 
PRESCRIPTION DRUG COSTS 
SEC. 6701. OVERSIGHT OF PHARMACY BENEFIT MANAGE-
MENT SERVICES. 
(a) PUBLIC HEALTH SERVICE ACT.—Title XXVII of 
the Public Health Service Act (42 U.S.C. 300gg et seq.) 
is amended— 
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853 
(1) in part D (42 U.S.C. 300gg–111 et seq.), 
by adding at the end the following new section: 
‘‘SEC. 2799A–11. OVERSIGHT OF ENTITIES THAT PROVIDE 
PHARMACY BENEFIT MANAGEMENT SERV-
ICES. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after the date that is 30 months after the date of enact-
ment of this section (referred to in this subsection and 
subsection (b) as the ‘effective date’), a group health plan 
or a health insurance issuer offering group health insur-
ance coverage, or an entity providing pharmacy benefit 
management services on behalf of such a plan or issuer, 
shall not enter into a contract, including an extension or 
renewal of a contract, entered into on or after the effective 
date, with an applicable entity unless such applicable enti-
ty agrees to— 
‘‘(1) not limit or delay the disclosure of infor-
mation to the group health plan (including such a 
plan offered through a health insurance issuer) in 
such a manner that prevents an entity providing 
pharmacy benefit management services on behalf of 
a group health plan or health insurance issuer offer-
ing group health insurance coverage from making 
the reports described in subsection (b); and 
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854 
‘‘(2) provide the entity providing pharmacy ben-
efit management services on behalf of a group health 
plan or health insurance issuer relevant information 
necessary to make the reports described in sub-
section (b). 
‘‘(b) REPORTS.— 
‘‘(1) IN GENERAL.—For plan years beginning 
on or after the effective date, in the case of any con-
tract between a group health plan or a health insur-
ance issuer offering group health insurance coverage 
offered in connection with such a plan and an entity 
providing pharmacy benefit management services on 
behalf of such plan or issuer, including an extension 
or renewal of such a contract, entered into on or 
after the effective date, the entity providing phar-
macy benefit management services on behalf of such 
a group health plan or health insurance issuer, not 
less frequently than every 6 months (or, at the re-
quest of a group health plan, not less frequently 
than quarterly, and under the same conditions, 
terms, and cost of the semiannual report under this 
subsection), shall submit to the group health plan a 
report in accordance with this section. Each such re-
port shall be made available to such group health 
plan in plain language, in a machine-readable for-
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855 
mat, and as the Secretary may determine, other for-
mats. Each such report shall include the information 
described in paragraph (2). 
‘‘(2) INFORMATION DESCRIBED.—For purposes 
of paragraph (1), the information described in this 
paragraph is, with respect to drugs covered by a 
group health plan or group health insurance cov-
erage offered by a health insurance issuer in connec-
tion with a group health plan during each reporting 
period— 
‘‘(A) in the case of a group health plan 
that is offered by a specified large employer or 
that is a specified large plan, and is not offered 
as health insurance coverage, or in the case of 
health insurance coverage for which the election 
under paragraph (3) is made for the applicable 
reporting period— 
‘‘(i) a list of drugs for which a claim 
was filed and, with respect to each such 
drug on such list— 
‘‘(I) the contracted compensation 
paid by the group health plan or 
health insurance issuer for each cov-
ered drug (identified by the National 
Drug Code) to the entity providing 
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856 
pharmacy benefit management serv-
ices or other applicable entity on be-
half of the group health plan or health 
insurance issuer; 
‘‘(II) the contracted compensa-
tion paid to the pharmacy, by any en-
tity providing pharmacy benefit man-
agement services or other applicable 
entity on behalf of the group health 
plan or health insurance issuer, for 
each covered drug (identified by the 
National Drug Code); 
‘‘(III) for each such claim, the 
difference between the amount paid 
under subclause (I) and the amount 
paid under subclause (II); 
‘‘(IV) the proprietary name, es-
tablished name or proper name, and 
the National Drug Code; 
‘‘(V) for each claim for the drug 
(including original prescriptions and 
refills) and for each dosage unit of the 
drug for which a claim was filed, the 
type of dispensing channel used to 
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857 
furnish the drug, including retail, mail 
order, or specialty pharmacy; 
‘‘(VI) with respect to each drug 
dispensed, for each type of dispensing 
channel (including retail, mail order, 
or specialty pharmacy)— 
‘‘(aa) whether such drug is a 
brand name drug or a generic 
drug, and— 
‘‘(AA) in the case of a 
brand name drug, the whole-
sale acquisition cost, listed 
as cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(BB) in the case of a 
generic drug, the average 
wholesale price, listed as 
cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(bb) the total number of— 
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858 
‘‘(AA) 
prescription 
claims 
(including 
original 
prescriptions and refills); 
‘‘(BB) participants and 
beneficiaries for whom a 
claim for such drug was 
filed through the applicable 
dispensing channel; 
‘‘(CC) dosage units and 
dosage units per fill of such 
drug; and 
‘‘(DD) days supply of 
such drug per fill; 
‘‘(VII) the net price per course of 
treatment or single fill, such as a 30- 
day supply or 90-day supply to the 
plan or coverage after rebates, fees, 
alternative discounts, or other remu-
neration received from applicable enti-
ties; 
‘‘(VIII) the total amount of out- 
of-pocket spending by participants 
and beneficiaries on such drug, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not 
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859 
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage, or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(IX) the total net spending on 
the drug; 
‘‘(X) the total amount received, 
or expected to be received, by the plan 
or issuer from any applicable entity in 
rebates, fees, alternative discounts, or 
other remuneration; 
‘‘(XI) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
counts, or other remuneration from 
such entities— 
‘‘(aa) for claims incurred 
during the reporting period; and 
‘‘(bb) that is related to utili-
zation of such drug or spending 
on such drug; and 
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860 
‘‘(XII) to the extent feasible, in-
formation on the total amount of re-
muneration for such drug, including 
copayment assistance dollars paid, co-
payment cards applied, or other dis-
counts provided by each drug manu-
facturer (or entity administering co-
payment assistance on behalf of such 
drug manufacturer), to the partici-
pants and beneficiaries enrolled in 
such plan or coverage; 
‘‘(ii) a list of each therapeutic class 
(as defined by the Secretary) for which a 
claim was filed under the group health 
plan or health insurance coverage during 
the reporting period, and, with respect to 
each such therapeutic class— 
‘‘(I) the total gross spending on 
drugs in such class before rebates, 
price 
concessions, 
alternative 
dis-
counts, or other remuneration from 
applicable entities; 
‘‘(II) the net spending in such 
class after such rebates, price conces-
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861 
sions, alternative discounts, or other 
remuneration from applicable entities; 
‘‘(III) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
counts, or other remuneration from 
such entities— 
‘‘(aa) for claims incurred 
during the reporting period; and 
‘‘(bb) that is related to utili-
zation of drugs or drug spending; 
‘‘(IV) the average net spending 
per 30-day supply and per 90-day 
supply by the plan or by the issuer 
with respect to such coverage and its 
participants and beneficiaries, among 
all drugs within the therapeutic class 
for which a claim was filed during the 
reporting period; 
‘‘(V) the number of participants 
and beneficiaries who filled a prescrip-
tion for a drug in such class, includ-
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862 
ing the National Drug Code for each 
such drug; 
‘‘(VI) if applicable, a description 
of the formulary tiers and utilization 
mechanisms (such as prior authoriza-
tion or step therapy) employed for 
drugs in that class; and 
‘‘(VII) the total out-of-pocket 
spending under the plan or coverage 
by participants and beneficiaries, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not 
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(iii) with respect to any drug for 
which gross spending under the group 
health plan or health insurance coverage 
exceeded $10,000 during the reporting pe-
riod or, in the case that gross spending 
under the group health plan or coverage 
exceeded $10,000 during the reporting pe-
riod with respect to fewer than 50 drugs, 
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863 
with respect to the 50 prescription drugs 
with the highest spending during the re-
porting period— 
‘‘(I) a list of all other drugs in 
the same therapeutic class as such 
drug; 
‘‘(II) if applicable, the rationale 
for the formulary placement of such 
drug in that therapeutic category or 
class, selected from a list of standard 
rationales established by the Sec-
retary, in consultation with stake-
holders; and 
‘‘(III) any change in formulary 
placement compared to the prior plan 
year; and 
‘‘(iv) in the case that such plan or 
issuer (or an entity providing pharmacy 
benefit management services on behalf of 
such plan or issuer) has an affiliated phar-
macy or pharmacy under common owner-
ship, including mandatory mail and spe-
cialty home delivery programs, retail and 
mail auto-refill programs, and cost sharing 
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864 
assistance incentives funded by an entity 
providing pharmacy benefit services— 
‘‘(I) an explanation of any ben-
efit design parameters that encourage 
or require participants and bene-
ficiaries in the plan or coverage to fill 
prescriptions at mail order, specialty, 
or retail pharmacies; 
‘‘(II) the percentage of total pre-
scriptions dispensed by such phar-
macies to participants or beneficiaries 
in such plan or coverage; and 
‘‘(III) a list of all drugs dis-
pensed by such pharmacies to partici-
pants or beneficiaries enrolled in such 
plan or coverage, and, with respect to 
each drug dispensed— 
‘‘(aa) the amount charged, 
per dosage unit, per 30-day sup-
ply, or per 90-day supply (as ap-
plicable) to the plan or issuer, 
and to participants and bene-
ficiaries; 
‘‘(bb) the median amount 
charged to such plan or issuer, 
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865 
and the interquartile range of the 
costs, per dosage unit, per 30- 
day supply, and per 90-day sup-
ply, including amounts paid by 
the 
participants 
and 
bene-
ficiaries, when the same drug is 
dispensed by other pharmacies 
that are not affiliated with or 
under common ownership with 
the entity and that are included 
in the pharmacy network of such 
plan or coverage; 
‘‘(cc) the lowest cost per 
dosage unit, per 30-day supply 
and per 90-day supply, for each 
such drug, including amounts 
charged to the plan or coverage 
and to participants and bene-
ficiaries, that is available from 
any pharmacy included in the 
network of such plan or coverage; 
and 
‘‘(dd) the net acquisition 
cost per dosage unit, per 30-day 
supply, and per 90-day supply, if 
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866 
such drug is subject to a max-
imum price discount; and 
‘‘(B) with respect to any group health 
plan, including group health insurance coverage 
offered in connection with such a plan, regard-
less of whether the plan or coverage is offered 
by a specified large employer or whether it is a 
specified large plan— 
‘‘(i) a summary document for the 
group health plan that includes such infor-
mation described in clauses (i) through (iv) 
of subparagraph (A), as specified by the 
Secretary through guidance, program in-
struction, or otherwise (with no require-
ment of notice and comment rulemaking), 
that the Secretary determines useful to 
group health plans for purposes of select-
ing pharmacy benefit management serv-
ices, such as an estimated net price to 
group health plan and participant or bene-
ficiary, a cost per claim, the fee structure 
or reimbursement model, and estimated 
cost per participant or beneficiary; 
‘‘(ii) a summary document for plans 
and issuers to provide to participants and 
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867 
beneficiaries, which shall be made available 
to participants or beneficiaries upon re-
quest to their group health plan (including 
in the case of group health insurance cov-
erage offered in connection with such a 
plan), that— 
‘‘(I) contains such information 
described in clauses (iii), (iv), (v), and 
(vi), as applicable, as specified by the 
Secretary through guidance, program 
instruction, or otherwise (with no re-
quirement of notice and comment 
rulemaking) that the Secretary deter-
mines useful to participants or bene-
ficiaries in better understanding the 
plan or coverage or benefits under 
such plan or coverage; 
‘‘(II) contains only aggregate in-
formation; and 
‘‘(III) states that participants 
and beneficiaries may request specific, 
claims-level information required to be 
furnished under subsection (c) from 
the group health plan or health insur-
ance issuer; and 
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868 
‘‘(iii) with respect to drugs covered by 
such plan or coverage during such report-
ing period— 
‘‘(I) the total net spending by the 
plan or coverage for all such drugs; 
‘‘(II) the total amount received, 
or expected to be received, by the plan 
or issuer from any applicable entity in 
rebates, fees, alternative discounts, or 
other remuneration; and 
‘‘(III) to the extent feasible, in-
formation on the total amount of re-
muneration for such drugs, including 
copayment assistance dollars paid, co-
payment cards applied, or other dis-
counts provided by each drug manu-
facturer (or entity administering co-
payment assistance on behalf of such 
drug manufacturer) to participants 
and beneficiaries; 
‘‘(iv) amounts paid directly or indi-
rectly in rebates, fees, or any other type of 
compensation 
(as 
defined 
in 
section 
408(b)(2)(B)(ii)(dd)(AA) of the Employee 
Retirement Income Security Act) to bro-
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869 
kerage firms, brokers, consultants, advi-
sors, or any other individual or firm, for— 
‘‘(I) the referral of the group 
health plan’s or health insurance 
issuer’s business to an entity pro-
viding pharmacy benefit management 
services, including the identity of the 
recipient of such amounts; 
‘‘(II) consideration of the entity 
providing pharmacy benefit manage-
ment services by the group health 
plan or health insurance issuer; or 
‘‘(III) the retention of the entity 
by the group health plan or health in-
surance issuer; 
‘‘(v) an explanation of any benefit de-
sign parameters that encourage or require 
participants and beneficiaries in such plan 
or coverage to fill prescriptions at mail 
order, specialty, or retail pharmacies that 
are affiliated with or under common own-
ership with the entity providing pharmacy 
benefit management services under such 
plan or coverage, including mandatory mail 
and specialty home delivery programs, re-
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870 
tail and mail auto-refill programs, and 
cost-sharing assistance incentives directly 
or indirectly funded by such entity; and 
‘‘(vi) total gross spending on all drugs 
under the plan or coverage during the re-
porting period. 
‘‘(3) OPT-IN FOR GROUP HEALTH INSURANCE 
COVERAGE OFFERED BY A SPECIFIED LARGE EM-
PLOYER OR THAT IS A SPECIFIED LARGE PLAN.—In 
the case of group health insurance coverage offered 
in connection with a group health plan that is of-
fered by a specified large employer or is a specified 
large plan, such group health plan may, on an an-
nual basis, for plan years beginning on or after the 
date that is 30 months after the date of enactment 
of this section, elect to require an entity providing 
pharmacy benefit management services on behalf of 
the health insurance issuer to submit to such group 
health plan a report that includes all of the informa-
tion described in paragraph (2)(A), in addition to 
the information described in paragraph (2)(B). 
‘‘(4) PRIVACY REQUIREMENTS.— 
‘‘(A) IN
GENERAL.—An entity providing 
pharmacy benefit management services on be-
half of a group health plan or a health insur-
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871 
ance issuer offering group health insurance cov-
erage shall report information under paragraph 
(1) in a manner consistent with the privacy reg-
ulations promulgated under section 13402(a) of 
the Health Information Technology for Eco-
nomic and Clinical Health Act and consistent 
with the privacy regulations promulgated under 
the Health Insurance Portability and Account-
ability Act of 1996 in part 160 and subparts A 
and E of part 164 of title 45, Code of Federal 
Regulations (or successor regulations) (referred 
to in this paragraph as the ‘HIPAA privacy 
regulations’) and shall restrict the use and dis-
closure of such information according to such 
privacy regulations and such HIPAA privacy 
regulations. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) IN
GENERAL.—An entity pro-
viding pharmacy benefit management serv-
ices on behalf of a group health plan or 
health insurance issuer offering group 
health insurance coverage that submits a 
report under paragraph (1) shall ensure 
that such report contains only summary 
health information, as defined in section 
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872 
164.504(a) of title 45, Code of Federal 
Regulations (or successor regulations). 
‘‘(ii) RESTRICTIONS.—In carrying out 
this subsection, a group health plan shall 
comply with section 164.504(f) of title 45, 
Code of Federal Regulations (or a suc-
cessor regulation), and a plan sponsor shall 
act in accordance with the terms of the 
agreement described in such section. 
‘‘(C) RULE OF CONSTRUCTION.— 
‘‘(i) Nothing in this section shall be 
construed to modify the requirements for 
the creation, receipt, maintenance, or 
transmission of protected health informa-
tion under the HIPAA privacy regulations. 
‘‘(ii) Nothing in this section shall be 
construed to affect the application of any 
Federal or State privacy or civil rights law, 
including the HIPAA privacy regulations, 
the Genetic Information Nondiscrimination 
Act of 2008 (Public Law 110–233) (in-
cluding the amendments made by such 
Act), the Americans with Disabilities Act 
of 1990 (42 U.S.C. 12101 et seq.), section 
504 of the Rehabilitation Act of 1973 (29 
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873 
U.S.C. 794), section 1557 of the Patient 
Protection and Affordable Care Act (42 
U.S.C. 18116), title VI of the Civil Rights 
Act of 1964 (42 U.S.C. 2000d), and title 
VII of the Civil Rights Act of 1964 (42 
U.S.C. 2000e). 
‘‘(D) WRITTEN NOTICE.—Each plan year, 
group health plans, including with respect to 
group health insurance coverage offered in con-
nection with a group health plan, shall provide 
to each participant or beneficiary written notice 
informing the participant or beneficiary of the 
requirement for entities providing pharmacy 
benefit management services on behalf of the 
group health plan or health insurance issuer of-
fering group health insurance coverage to sub-
mit reports to group health plans under para-
graph (1), as applicable, which may include in-
corporating such notification in plan documents 
provided to the participant or beneficiary, or 
providing individual notification. 
‘‘(E) LIMITATION
TO
BUSINESS
ASSOCI-
ATES.—A group health plan receiving a report 
under paragraph (1) may disclose such informa-
tion only to the entity from which the report 
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874 
was received or to that entity’s business associ-
ates as defined in section 160.103 of title 45, 
Code of Federal Regulations (or successor regu-
lations) or as permitted by the HIPAA privacy 
regulations. 
‘‘(F) CLARIFICATION REGARDING PUBLIC 
DISCLOSURE
OF
INFORMATION.—Nothing in 
this section shall prevent an entity providing 
pharmacy benefit management services on be-
half of a group health plan or health insurance 
issuer offering group health insurance coverage, 
from placing reasonable restrictions on the pub-
lic disclosure of the information contained in a 
report described in paragraph (1), except that 
such plan, issuer, or entity may not— 
‘‘(i) restrict disclosure of such report 
to the Department of Health and Human 
Services, the Department of Labor, or the 
Department of the Treasury; or 
‘‘(ii) prevent disclosure for the pur-
poses of subsection (c), or any other public 
disclosure requirement under this section. 
‘‘(G) LIMITED
FORM
OF
REPORT.—The 
Secretary shall define through rulemaking a 
limited form of the report under paragraph (1) 
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channel (including retail, mail order, 
or specialty pharmacy)— 
‘‘(aa) whether such drug is a 
brand name drug or a generic 
drug, and— 
‘‘(AA) in the case of a 
brand name drug, the whole-
sale acquisition cost, listed 
as cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(BB) in the case of a 
generic drug, the average 
wholesale price, listed as 
cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(bb) the total number of— 
‘‘(AA) 
prescription 
claims 
(including 
original 
prescriptions and refills); 
‘‘(BB) participants and 
beneficiaries for whom a 
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