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fide service fees, attributable to 
the drug and retained by the 
pharmacy benefit manager and 
any affiliate of such pharmacy 
benefit manager. 
‘‘(II) In the case of a pharmacy 
benefit manager that has an affiliate 
that is a retail, mail order, or spe-
cialty pharmacy, with respect to drugs 
covered by such plan that were dis-
pensed, the following information: 
‘‘(aa) The percentage of 
total prescriptions that were dis-
pensed by pharmacies that are an 
affiliate of the pharmacy benefit 
manager for each drug. 
‘‘(bb) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
ees, per dosage unit, per course 
of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are not an affiliate of the 
pharmacy benefit manager and 
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that are included in the phar-
macy network of such plan. 
‘‘(cc) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
ees, per dosage unit, per course 
of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are an affiliate of the phar-
macy benefit manager and that 
are included in the pharmacy 
network of such plan. 
‘‘(dd) The lowest total com-
bined cost paid by the plan and 
plan enrollees, per dosage unit, 
per course of treatment, per 30- 
day supply, and per 90-day sup-
ply, for each drug that is avail-
able from any pharmacy included 
in the pharmacy network of such 
plan. 
‘‘(ee) The difference between 
the average acquisition cost of 
the affiliate, such as a pharmacy 
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or other entity that acquires pre-
scription drugs, that initially ac-
quires the drug and the amount 
reported under subclause (I)(jj) 
for each drug. 
‘‘(ff) A list inclusive of the 
brand name, generic or non-pro-
prietary 
name, 
and 
National 
Drug Code of covered part D 
drugs subject to an agreement 
with a covered entity under sec-
tion 340B of the Public Health 
Service Act for which the phar-
macy benefit manager or an affil-
iate of the pharmacy benefit 
manager had a contract or other 
arrangement with such a covered 
entity in the service area of such 
plan. 
‘‘(III) Where a drug approved 
under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (re-
ferred to in this subclause as the ‘list-
ed drug’) is covered by the plan, the 
following information: 
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‘‘(aa) A list of currently 
marketed generic drugs approved 
under section 505(j) of the Fed-
eral Food, Drug, and Cosmetic 
Act pursuant to an application 
that references such listed drug 
that are not covered by the plan, 
are covered on the same for-
mulary tier or a formulary tier 
typically associated with higher 
cost-sharing than the listed drug, 
or are subject to utilization man-
agement that the listed drug is 
not subject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the listed drug. 
‘‘(cc) Where a generic drug 
listed under item (aa) is on a for-
mulary tier typically associated 
with higher cost-sharing than the 
listed drug, the estimated aver-
age cost-sharing that a bene-
ficiary would have paid for a 30- 
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day supply of each of the generic 
drugs described in item (aa), had 
the plan provided coverage for 
such drugs on the same for-
mulary tier as the listed drug. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the listed drug than the 
generic drugs described in item 
(aa). 
‘‘(ee) The number of cur-
rently marketed generic drugs 
approved under section 505(j) of 
the Federal Food, Drug, and 
Cosmetic Act pursuant to an ap-
plication that references such 
listed drug. 
‘‘(IV) Where a reference product 
(as defined in section 351(i) of the 
Public Health Service Act) is covered 
by the plan, the following information: 
‘‘(aa) A list of currently 
marketed 
biosimilar 
biological 
products licensed under section 
351(k) of the Public Health 
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Service Act pursuant to an appli-
cation that refers to such ref-
erence product that are not cov-
ered by the plan, are covered on 
the same formulary tier or a for-
mulary tier typically associated 
with higher cost-sharing than the 
reference product, or are subject 
to utilization management that 
the reference product is not sub-
ject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the reference product. 
‘‘(cc) Where a biosimilar bi-
ological product listed under item 
(aa) is on a formulary tier typi-
cally associated with higher cost- 
sharing than the reference prod-
uct, the estimated average cost- 
sharing that a beneficiary would 
have paid for a 30-day supply of 
each of the biosimilar biological 
products described in item (aa), 
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had the plan provided coverage 
for such products on the same 
formulary tier as the reference 
product. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the reference product 
than the biosimilar biological 
products described in item (aa). 
‘‘(ee) The number of cur-
rently marketed biosimilar bio-
logical products licensed under 
section 351(k) of the Public 
Health Service Act, pursuant to 
an application that refers to such 
reference product. 
‘‘(V) Total gross spending on 
covered part D drugs by the plan, not 
net of rebates, fees, discounts, or 
other direct or indirect remuneration. 
‘‘(VI) The total amount retained 
by the pharmacy benefit manager or 
an affiliate of such pharmacy benefit 
manager in revenue related to utiliza-
tion of covered part D drugs under 
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that plan, inclusive of bona fide serv-
ice fees. 
‘‘(VII) The total spending on cov-
ered part D drugs net of rebates, fees, 
discounts, or other direct and indirect 
remuneration by the plan. 
‘‘(VIII) An explanation of any 
benefit design parameters under such 
plan that encourage plan enrollees to 
fill prescriptions at pharmacies that 
are an affiliate of such pharmacy ben-
efit manager, such as mail and spe-
cialty home delivery programs, and re-
tail and mail auto-refill programs. 
‘‘(IX) The following information: 
‘‘(aa) A list of all brokers, 
consultants, advisors, and audi-
tors that receive compensation 
from the pharmacy benefit man-
ager or an affiliate of such phar-
macy benefit manager for refer-
rals, 
consulting, 
auditing, 
or 
other services offered to PDP 
sponsors related to pharmacy 
benefit management services. 
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‘‘(bb) The amount of com-
pensation provided by such phar-
macy benefit manager or affiliate 
to each such broker, consultant, 
advisor, and auditor. 
‘‘(cc) The methodology for 
calculating the amount of com-
pensation provided by such phar-
macy benefit manager or affil-
iate, for each such broker, con-
sultant, advisor, and auditor. 
‘‘(X) A list of all affiliates of the 
pharmacy benefit manager. 
‘‘(XI) A summary document sub-
mitted in a standardized template de-
veloped by the Secretary that includes 
such information described in sub-
clauses (I) through (X). 
‘‘(ii) WRITTEN EXPLANATION OF CON-
TRACTS OR AGREEMENTS WITH MANUFAC-
TURERS.— 
‘‘(I) IN
GENERAL.—The phar-
macy benefit manager shall, not later 
than 30 days after the finalization of 
any contract or agreement between 
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such pharmacy benefit manager or an 
affiliate of such pharmacy benefit 
manager and a manufacturer (or sub-
sidiary, agent, or entity affiliated with 
such manufacturer) that makes re-
bates, discounts, payments, or other 
financial incentives related to one or 
more covered part D drugs or other 
prescription drugs, as applicable, of 
the manufacturer directly or indirectly 
contingent upon coverage, formulary 
placement, or utilization management 
conditions on any other covered part 
D drugs or other prescription drugs, 
as applicable, submit to the PDP 
sponsor a written explanation of such 
contract or agreement. 
‘‘(II) REQUIREMENTS.—A writ-
ten explanation under subclause (I) 
shall— 
‘‘(aa) include the manufac-
turer subject to the contract or 
agreement, all covered part D 
drugs 
and 
other 
prescription 
drugs, as applicable, subject to 
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the contract or agreement and 
the manufacturers of such drugs, 
and a high-level description of 
the terms of such contract or 
agreement and how such terms 
apply to such drugs; and 
‘‘(bb) be certified by the 
Chief Executive Officer, Chief Fi-
nancial Officer, or General Coun-
sel of such pharmacy benefit 
manager, or affiliate of such 
pharmacy benefit manager, as 
applicable, or an individual dele-
gated with the authority to sign 
on behalf of one of these officers, 
who reports directly to the offi-
cer. 
‘‘(III) DEFINITION
OF
OTHER 
PRESCRIPTION DRUGS.—For purposes 
of this clause, the term ‘other pre-
scription drugs’ means prescription 
drugs covered as supplemental bene-
fits under this part or prescription 
drugs paid outside of this part. 
‘‘(D) AUDIT RIGHTS.— 
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HR 7148 PCS
‘‘(i) IN GENERAL.—Not less than once 
a year, at the request of the PDP sponsor, 
the pharmacy benefit manager shall allow 
for an audit of the pharmacy benefit man-
ager to ensure compliance with all terms 
and conditions under the written agree-
ment described in this paragraph and the 
accuracy of information reported under 
subparagraph (C). 
‘‘(ii) AUDITOR.—The PDP sponsor 
shall have the right to select an auditor. 
The pharmacy benefit manager shall not 
impose any limitations on the selection of 
such auditor. 
‘‘(iii) PROVISION OF INFORMATION.— 
The pharmacy benefit manager shall make 
available to such auditor all records, data, 
contracts, and other information necessary 
to confirm the accuracy of information re-
ported under subparagraph (C), subject to 
reasonable restrictions on how such infor-
mation must be reported to prevent re-
disclosure of such information. 
‘‘(iv) TIMING.—The pharmacy benefit 
manager must provide information under 
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HR 7148 PCS
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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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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HR 7148 PCS
‘‘(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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HR 7148 PCS
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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HR 7148 PCS
(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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HR 7148 PCS
‘‘(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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HR 7148 PCS
‘‘(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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HR 7148 PCS
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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HR 7148 PCS
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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HR 7148 PCS
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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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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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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(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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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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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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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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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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‘‘(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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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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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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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 WTC 
Program on July 1 of such pre-
vious fiscal year; to 
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‘‘(bb) the total number of 
individuals so enrolled on July 1 
of the fiscal year prior to such 
previous fiscal year; and’’. 
(b) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sub-
section as the ‘‘Secretary’’) shall conduct an assess-
ment of anticipated budget authority and outlays of 
the World Trade Center Health Program (referred 
to in this subsection as the ‘‘Program’’) through the 
duration of the Program and submit a report sum-
marizing such assessment to— 
(A) the Speaker and minority leader of the 
House of Representatives; 
(B) the majority and minority leaders of 
the Senate; 
(C) the Committee on Health, Education, 
Labor, and Pensions and 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 XXXIII of the 
Public Health Service Act (42 U.S.C. 300mm et seq.) is 
amended— 
(1) in section 3352(d) (42 U.S.C. 300mm– 
62(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’; 
(2) in section 3353(d) (42 U.S.C. 300mm– 
63(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’; and 
(3) in section 3354(d) (42 U.S.C. 300mm– 
64(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’. 
TITLE V—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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(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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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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(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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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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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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