I 
118TH CONGRESS 
2D SESSION 
H. R. 8261 
To amend title XVIII of the Social Security Act to extend certain flexibilities 
and payment adjustments under the Medicare program, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 7, 2024 
Mr. SCHWEIKERT (for himself and Mr. THOMPSON of California) introduced 
the following bill; which was referred to the Committee on Ways and 
Means, and in addition to the Committee on Energy and Commerce, for 
a period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend title XVIII of the Social Security Act to extend 
certain flexibilities and payment adjustments under the 
Medicare program, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Preserving Telehealth, 
Hospital, and Ambulance Access Act’’. 
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TITLE 
I—PRESERVING 
PA-
TIENTS’ ACCESS TO CARE IN 
THE HOME 
SEC. 101. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILI-
TIES. 
(a) REMOVING GEOGRAPHIC REQUIREMENTS
AND 
EXPANDING
ORIGINATING
SITES
FOR
TELEHEALTH 
SERVICES.—Section 1834(m) of the Social Security Act 
(42 U.S.C. 1395m) is amended— 
(1) in paragraph (2)(B)(iii), by striking ‘‘end-
ing December 31, 2024’’ and inserting ‘‘ending De-
cember 31, 2026’’; and 
(2) in paragraph (4)(C)(iii), by striking ‘‘ending 
on December 31, 2024’’ and inserting ‘‘ending on 
December 31, 2026’’. 
(b) EXPANDING PRACTITIONERS ELIGIBLE TO FUR-
NISH TELEHEALTH SERVICES.—Section 1834(m)(4)(E) 
of the Social Security Act (42 U.S.C. 1395m(m)(4)(E)) 
is amended by striking ‘‘ending on December 31, 2024’’ 
and inserting ‘‘ending on December 31, 2026’’. 
(c) EXTENDING TELEHEALTH SERVICES FOR FED-
ERALLY
QUALIFIED
HEALTH
CENTERS
AND
RURAL 
HEALTH CLINICS.—Section 1834(m)(8)(A) of the Social 
Security Act (42 U.S.C. 1395m(m)(8)(A)) is amended by 
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striking ‘‘ending on December 31, 2024’’ and inserting 
‘‘ending on December 31, 2026’’. 
(d) DELAYING
THE
IN-PERSON
REQUIREMENTS 
UNDER MEDICARE
FOR MENTAL HEALTH SERVICES 
FURNISHED
THROUGH
TELEHEALTH
AND
TELE-
COMMUNICATIONS TECHNOLOGY.— 
(1) DELAY
IN
REQUIREMENTS
FOR
MENTAL 
HEALTH
SERVICES
FURNISHED
THROUGH
TELE-
HEALTH.—Section 1834(m)(7)(B)(i) of the Social 
Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is 
amended, in the matter preceding subclause (I), by 
striking ‘‘on or after’’ and all that follows through 
‘‘described in section 1135(g)(1)(B))’’ and inserting 
‘‘on or after January 1, 2027’’. 
(2) MENTAL
HEALTH
VISITS
FURNISHED
BY 
RURAL HEALTH CLINICS.—Section 1834(y)(2) of the 
Social Security Act (42 U.S.C. 1395m(y)(2)) is 
amended by striking ‘‘January 1, 2025’’ and all that 
follows through the period at the end and inserting 
‘‘January 1, 2027.’’. 
(3) MENTAL
HEALTH
VISITS
FURNISHED
BY 
FEDERALLY QUALIFIED HEALTH CENTERS.—Section 
1834(o)(4)(B) of the Social Security Act (42 U.S.C. 
1395m(o)(4)(B)) is amended by striking ‘‘January 
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enrolled under section 1866(j) and is not an opt-out 
physician or practitioner (as defined in section 
1802(b)(6)(D))’’ before the semicolon. 
(g) PROGRAM INSTRUCTION AUTHORITY.—The Sec-
retary of Health and Human Services may implement the 
amendments made by this section through program in-
struction or otherwise. 
SEC. 102. GUIDANCE ON FURNISHING SERVICES VIA TELE-
HEALTH TO INDIVIDUALS WITH LIMITED 
ENGLISH PROFICIENCY. 
(a) IN GENERAL.—Not later than 1 year after the 
date of the enactment of this section, the Secretary of 
Health and Human Services, in consultation with 1 or 
more entities from each of the categories described in 
paragraphs (1) through (7) of subsection (b), shall issue 
and disseminate, or update and revise as applicable, guid-
ance for the entities described in such subsection on the 
following: 
(1) Best practices on facilitating and inte-
grating use of interpreters during a telemedicine ap-
pointment. 
(2) Best practices on providing accessible in-
structions on how to access telecommunications sys-
tems (as such term is used for purposes of section 
1834(m) of the Social Security Act (42 U.S.C. 
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1395m(m)) for individuals with limited English pro-
ficiency. 
(3) Best practices on improving access to dig-
ital patient portals for individuals with limited 
English proficiency. 
(4) Best practices on integrating the use of 
video platforms that enable multi-person video calls 
furnished via a telecommunications system for pur-
poses of providing interpretation during a telemedi-
cine appointment for an individual with limited 
English proficiency. 
(5) Best practices for providing patient mate-
rials, communications, and instructions in multiple 
languages, including text message appointment re-
minders and prescription information. 
(b) ENTITIES DESCRIBED.—For purposes of sub-
section (a), an entity described in this subsection is an 
entity in 1 or more of the following categories: 
(1) Health information technology service pro-
viders, including— 
(A) electronic medical record companies; 
(B) remote patient monitoring companies; 
and 
(C) telehealth or mobile health vendors and 
companies. 
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(2) Health care providers, including— 
(A) physicians; and 
(B) hospitals. 
(3) Health insurers. 
(4) Language service companies. 
(5) Interpreter or translator professional asso-
ciations. 
(6) Health and language services quality certifi-
cation organizations. 
(7) Patient and consumer advocates, including 
such advocates that work with individuals with lim-
ited English proficiency. 
SEC. 103. ESTABLISHMENT OF MODIFIER FOR RECERTIFI-
CATIONS OF HOSPICE CARE ELIGIBILITY 
CONDUCTED THROUGH TELEHEALTH. 
Section 1814(a)(7)(D)(i)(II) of the Social Security 
Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)), as amended by sec-
tion 101(f), is further amended by inserting ‘‘, provided 
that, in the case of such an encounter occurring on or 
after the date that is 2 years after the date of the enact-
ment of the ‘Preserving Telehealth, Hospital, and Ambu-
lance Access Act’, such physician or nurse practitioner in-
cludes in any claim for such encounter one or more modi-
fiers or codes specified by the Secretary to indicate that 
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such encounter was furnished through telehealth’’ after 
‘‘as determined appropriate by the Secretary’’. 
SEC. 104. EXTENDING ACUTE HOSPITAL CARE AT HOME 
WAIVER FLEXIBILITIES. 
Section 1866G of the Social Security Act (42 U.S.C. 
1395cc–7) is amended— 
(1) in subsection (a)(1), by striking ‘‘2024’’ and 
inserting ‘‘2029’’; and 
(2) in subsection (b)— 
(A) in the header, by striking ‘‘STUDY AND 
REPORT’’ and inserting ‘‘STUDIES
AND RE-
PORTS’’; 
(B) in paragraph (1)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘The Secretary’’ 
and inserting ‘‘Not later than September 
30, 2024, and again not later than Sep-
tember 30, 2028, the Secretary’’; 
(ii) in clause (vi), by striking ‘‘and’’ at 
the end; 
(iii) in clause (vii), by striking the pe-
riod and inserting ‘‘; and’’; and 
(iv) by adding at the end the following 
new clause: 
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‘‘(viii) in the case of the second study 
conducted under this paragraph, the qual-
ity of care, outcomes, costs, quantity and 
intensity of services, and other relevant 
metrics between individuals who entered 
into the Acute Hospital Care at Home ini-
tiative directly from an emergency depart-
ment compared with individuals who en-
tered into the Acute Hospital Care at 
Home initiative directly from an existing 
inpatient stay in a hospital.’’; and 
(C) in paragraph (2)— 
(i) in the header, by striking ‘‘RE-
PORT’’ and inserting ‘‘REPORTS’’; and 
(ii) by inserting ‘‘and again not later 
than September 30, 2028,’’ after ‘‘2024,’’; 
and 
(iii) by striking ‘‘on the study con-
ducted under paragraph (1).’’ and insert-
ing the following: ‘‘on— 
‘‘(A) with respect to the first report sub-
mitted under this paragraph, the first study 
conducted under paragraph (1); and 
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‘‘(B) with respect to the second report sub-
mitted under this paragraph, the second study 
conducted under paragraph (1).’’. 
SEC. 105. REPORT ON WEARABLE MEDICAL DEVICES. 
Not later than 18 months after the date of the enact-
ment of this Act, the Comptroller General of the United 
States shall conduct a technology assessment of, and sub-
mit to Congress a report on, the capabilities and limita-
tions of wearable medical devices used to support clinical 
decision-making. Such report shall include a description 
of— 
(1) the potential for such devices to accurately 
prescribe treatments; 
(2) an examination of the benefits and chal-
lenges of artificial intelligence to augment such ca-
pabilities; and 
(3) policy options to enhance the benefits and 
mitigate potential challenges of developing or using 
such devices. 
SEC. 106. ENHANCING CERTAIN PROGRAM INTEGRITY RE-
QUIREMENTS FOR DME UNDER MEDICARE. 
(a) 
DURABLE
MEDICAL
EQUIPMENT.—Section 
1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) 
is amended by adding at the end the following new para-
graph: 
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‘‘(23) MASTER LIST INCLUSION AND CLAIM RE-
VIEW FOR CERTAIN ITEMS.— 
‘‘(A) MASTER
LIST
INCLUSION.—Begin-
ning January 1, 2026, for purposes of the Mas-
ter List described in section 414.234(b) of title 
42, Code of Federal Regulations (or any suc-
cessor regulation), an item for which payment 
may be made under this subsection shall be 
treated as having aberrant billing patterns (as 
such term is used for purposes of such section) 
if the Secretary determines that, without ex-
planatory contributing factors (such as fur-
nishing emergent care services), a substantial 
number of written orders for such items under 
this subsection are from an ordering physician 
or applicable practitioner with whom the indi-
vidual involved does not have a prior relation-
ship, as determined on the basis of prior pay-
ment experience. 
‘‘(B) CLAIM
REVIEW.—With respect to 
items furnished on or after January 1, 2026 
that are included on the Master List pursuant 
to subparagraph (A), if such an item is not sub-
ject to a determination of coverage in advance 
pursuant to paragraph (15)(C), the Secretary 
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may conduct prepayment review of claims for 
payment for such item.’’. 
(b) REPORT ON IDENTIFYING CLINICAL DIAGNOSTIC 
LABORATORY TESTS AT HIGH RISK FOR FRAUD AND EF-
FECTIVE MITIGATION MEASURES.—Not later than Janu-
ary 1, 2026, the Inspector General of the Department of 
Health and Human Services shall submit to Congress a 
report assessing fraudulent claims for clinical diagnostic 
laboratory tests for which payment may be made under 
section 1834A of the Social Security Act (42 U.S.C. 
1395m–1) and effective tools for reducing such fraudulent 
claims. The report shall include— 
(1) which, if any, clinical diagnostic laboratory 
tests are identified as being at high risk of fraudu-
lent claims, and an analysis of the factors that con-
tribute to such risk; 
(2) with respect to a clinical diagnostic labora-
tory test identified under subparagraph (A) as being 
at high risk of fraudulent claims— 
(A) the amount payable under such section 
1834A with respect to such test; 
(B) the number of such tests furnished to 
individuals enrolled under part B of title XVIII 
of the Social Security Act (42 U.S.C. 1395j et 
seq.); 
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(C) whether an order for such a test was 
more likely to come from a provider with whom 
the individual involved did not have a prior re-
lationship, as determined on the basis of prior 
payment experience; and 
(D) the frequency with which a claim for 
payment under such section 1834A included the 
payment modifier identified by code 59 or 91; 
and 
(3) suggested strategies for reducing the num-
ber of fraudulent claims made with respect to tests 
so identified as being at high risk, including— 
(A) an analysis of whether the Centers for 
Medicare & Medicaid Services can detect aber-
rant billing patterns with respect to such tests 
in a timely manner; 
(B) any strategies for identifying and mon-
itoring the providers who are outliers with re-
spect to the number of such tests that such pro-
viders order; and 
(C) targeted education efforts to mitigate 
improper billing for such tests. 
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TITLE II—SUSTAINING ACCESS 
TO 
HOSPITAL 
AND 
EMER-
GENCY SERVICES 
SEC. 201. EXTENSION OF INCREASED INPATIENT HOSPITAL 
PAYMENT ADJUSTMENT FOR CERTAIN LOW- 
VOLUME HOSPITALS. 
(a) IN GENERAL.—Section 1886(d)(12) of the Social 
Security Act (42 U.S.C. 1395ww(d)(12)) is amended— 
(1) in subparagraph (B), by striking ‘‘during 
the portion of fiscal year 2025 beginning on January 
1, 2025, and ending on September 30, 2025, and’’; 
(2) in subparagraph (C)(i)— 
(A) in the matter preceding subclause 
(I)— 
(i) by striking ‘‘or portion of a fiscal 
year’’; and 
(ii) by striking ‘‘2024 and the portion 
of fiscal year 2025 beginning on October 1, 
2024, and ending on December 31, 2024’’ 
and inserting ‘‘2025’’; 
(B) in subclause (III), by striking ‘‘2024 
and the portion of fiscal year 2025 beginning 
on October 1, 2024, and ending on December 
31, 2024’’ and inserting ‘‘2025’’; and 
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(C) in subclause (IV), by striking ‘‘the por-
tion of fiscal year 2025 beginning on January 
1, 2025, and ending on September 30, 2025, 
and’’; and 
(3) in subparagraph (D)— 
(A) in the matter preceding clause (i), by 
striking ‘‘2024 or during the portion of fiscal 
year 2025 beginning on October 1, 2024, and 
ending on December 31, 2024’’ and inserting 
‘‘2025’’; and 
(B) in clause (ii), by striking ‘‘ 2024 and 
the portion of fiscal year 2025 beginning on Oc-
tober 1, 2024, and ending on December 31, 
2024’’ and inserting ‘‘2025’’. 
(b) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human 
Services may implement the provisions of, including the 
amendments made by, this section by program instruction 
or otherwise. 
SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOS-
PITAL PROGRAM. 
(a) IN GENERAL.—Section 1886(d)(5)(G) of the So-
cial Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amend-
ed— 
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(1) in clause (i), by striking ‘‘January 1, 2025’’ 
and inserting ‘‘October 1, 2025’’; and 
(2) in clause (ii)(II), by striking ‘‘January 1, 
2025’’ and inserting ‘‘October 1, 2025’’. 
(b) CONFORMING AMENDMENTS.— 
(1) EXTENSION OF TARGET AMOUNT.—Section 
1886(b)(3)(D) of the Social Security Act (42 U.S.C. 
1395ww(b)(3)(D)) is amended— 
(A) in the matter preceding clause (i), by 
striking ‘‘January 1, 2025’’ and inserting ‘‘Oc-
tober 1, 2025’’; and 
(B) in clause (iv), by striking ‘‘2024 and 
the portion of fiscal year 2025 beginning on Oc-
tober 1, 2024, and ending on December 31, 
2024’’ and inserting ‘‘2025’’. 
(2) PERMITTING HOSPITALS TO DECLINE RE-
CLASSIFICATION.—Section 13501(e)(2) of the Omni-
bus Budget Reconciliation Act of 1993 (42 U.S.C. 
1395ww note) is amended by striking ‘‘2024, or the 
portion of fiscal year 2025 beginning on October 1, 
2024, and ending on December 31, 2024’’ and in-
serting ‘‘2025’’. 
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SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBU-
LANCE SERVICES. 
(a) IN GENERAL.—Section 1834(l) of the Social Se-
curity Act (42 U.S.C. 1395m(l)) is amended— 
(1) in paragraph (12)(A), by striking ‘‘January 
1, 2025’’ and inserting ‘‘October 1, 2025’’; and 
(2) in paragraph (13), by striking ‘‘January 1, 
2025’’ in each place it appears and inserting ‘‘Octo-
ber 1, 2025’’ in each such place. 
(b) PROGRAM INSTRUCTION AUTHORITY.—Notwith-
standing any other provision of law, the Secretary of 
Health and Human Services may implement the provisions 
of, including amendments made by, this section through 
program instruction or otherwise. 
TITLE III—OFFSETS 
SEC. 301. REVISING PHASE-IN OF MEDICARE CLINICAL LAB-
ORATORY 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 ‘‘2027’’ 
and inserting ‘‘2028’’; and 
(2) in subparagraph (B)— 
(A) in clause (ii), by striking ‘‘2024’’ and 
inserting ‘‘2025’’; and 
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(B) in clause (iii), by striking ‘‘2025 
through 2027’’ and inserting ‘‘2026 through 
2028’’. 
(b) 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 ‘‘2024’’ and insert-
ing ‘‘2025’’; and 
(2) in clause (ii), by striking ‘‘2025’’ each place 
it appears and inserting ‘‘2026’’. 
(c) IMPLEMENTATION.—The Secretary of Health and 
Human Services may implement the amendments made by 
this section by program instruction or otherwise. 
SEC. 302. ARRANGEMENTS WITH PHARMACY BENEFIT MAN-
AGERS WITH RESPECT TO PRESCRIPTION 
DRUG PLANS AND MA–PD PLANS. 
(a) IN GENERAL.— 
(1) 
PRESCRIPTION
DRUG
PLANS.—Section 
1860D–12 of the Social Security Act (42 U.S.C. 
1395w–112) is amended by adding at the end the 
following new subsection: 
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‘‘(h) REQUIREMENTS RELATING TO PHARMACY BEN-
EFIT MANAGERS.—For plan years beginning on or after 
January 1, 2027: 
‘‘(1) AGREEMENTS WITH PHARMACY BENEFIT 
MANAGERS.—Each contract entered into with a 
PDP sponsor under this part with respect to a pre-
scription drug plan offered by such sponsor shall 
provide that any pharmacy benefit manager acting 
on behalf of such sponsor has a written agreement 
with the PDP sponsor under which the pharmacy 
benefit manager, and any affiliates of such phar-
macy benefit manager, as applicable, agree to meet 
the following requirements: 
‘‘(A) NO INCOME OTHER THAN BONA FIDE 
SERVICE FEES.— 
‘‘(i) IN
GENERAL.—The pharmacy 
benefit manager and any affiliate of such 
pharmacy benefit manager shall not derive 
any remuneration with respect to any serv-
ices provided on behalf of any entity or in-
dividual, in connection with the utilization 
of covered part D drugs, from any such en-
tity or individual other than bona fide serv-
ice fees, subject to clauses (ii) and (iii). 
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‘‘(ii) INCENTIVE PAYMENTS.—For the 
purposes of this subsection, an incentive 
payment paid by a PDP sponsor to a phar-
macy benefit manager that is performing 
services on behalf of such sponsor shall be 
deemed a ‘bona fide service fee’(even if 
such payment does not otherwise meet the 
definition of such term under paragraph 
(7)(B)) if such payment is a flat dollar 
amount, is consistent with fair market 
value (as specified by the Secretary), is re-
lated to services actually performed by the 
pharmacy benefit manager or affiliate of 
such pharmacy benefit manager, on behalf 
of the entity making such payment, in con-
nection with the utilization of covered part 
D drugs, and meets additional require-
ments, if any, as determined appropriate 
by the Secretary. 
‘‘(iii) CLARIFICATION
ON
REBATES 
AND DISCOUNTS USED TO LOWER COSTS 
FOR COVERED PART D DRUGS.—Rebates, 
discounts, and other price concessions re-
ceived by a pharmacy benefit manager or 
an affiliate of a pharmacy benefit manager 
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from manufacturers, even if such price 
concessions are calculated as a percentage 
of a drug’s price, shall not be considered a 
violation of the requirements of clause (i) 
if they are fully passed through to a PDP 
sponsor and are compliant with all regu-
latory and subregulatory requirements re-
lated to direct and indirect remuneration 
for manufacturer rebates under this part, 
including in cases where a PDP sponsor is 
acting as a pharmacy benefit manager on 
behalf of a prescription drug plan offered 
by such PDP sponsor. 
‘‘(iv) EVALUATION OF REMUNERATION 
ARRANGEMENTS.—Components of subsets 
of remuneration arrangements (such as 
fees or other forms of compensation paid 
to or retained by the pharmacy benefit 
manager or affiliate of such pharmacy ben-
efit manager), as determined appropriate 
by the Secretary, between pharmacy ben-
efit managers or affiliates of such phar-
macy benefit managers, as applicable, and 
other entities involved in the dispensing or 
utilization of covered part D drugs (includ-
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ing PDP sponsors, manufacturers, phar-
macies, and other entities as determined 
appropriate by the Secretary) shall be sub-
ject to review by the Secretary, in con-
sultation with the Office of the Inspector 
General of the Department of Health and 
Human Services, as determined appro-
priate by the Secretary. The Secretary, in 
consultation with the Office of the Inspec-
tor General, shall review whether remu-
neration under such arrangements is con-
sistent with fair market value (as specified 
by the Secretary) through reviews and as-
sessments of such remuneration, as deter-
mined appropriate. 
‘‘(v) DISGORGEMENT.—The pharmacy 
benefit manager shall disgorge any remu-
neration paid to such pharmacy benefit 
manager or an affiliate of such pharmacy 
benefit manager in violation of this sub-
paragraph to the PDP sponsor. 
‘‘(vi) ADDITIONAL REQUIREMENTS.— 
The pharmacy benefit manager shall— 
‘‘(I) enter into a written agree-
ment with any affiliate of such phar-
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macy benefit manager, under which 
the affiliate shall identify and disgorge 
any remuneration described in clause 
(v) to the pharmacy benefit manager; 
and 
‘‘(II) attest, subject to any re-
quirements determined appropriate by 
the Secretary, that the pharmacy ben-
efit manager has entered into a writ-
ten agreement described in subclause 
(I) with any relevant affiliate of the 
pharmacy benefit manager. 
‘‘(B) TRANSPARENCY REGARDING GUARAN-
TEES
AND
COST
PERFORMANCE
EVALUA-
TIONS.—The pharmacy benefit manager shall— 
‘‘(i) define, interpret, and apply, in a 
fully transparent and consistent manner 
for purposes of calculating or otherwise 
evaluating pharmacy benefit manager per-
formance against pricing guarantees or 
similar cost performance measurements re-
lated to rebates, discounts, price conces-
sions, or net costs, terms such as— 
‘‘(I) ‘generic drug’, in a manner 
consistent with the definition of the 
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‘‘(C) PROVISION OF INFORMATION.— 
‘‘(i) IN
GENERAL.—Not later than 
July 1 of each year, beginning in 2027, the 
pharmacy benefit manager shall submit to 
the PDP sponsor, and to the Secretary, a 
report, in accordance with this subpara-
graph, and shall make such report avail-
able to such sponsor at no cost to such 
sponsor in a format specified by the Sec-
retary under paragraph (5). Each such re-
port shall include, with respect to such 
PDP sponsor and each plan offered by 
such sponsor, the following information 
with respect to the previous plan year: 
‘‘(I) A list of all drugs covered by 
the plan that were dispensed includ-
ing, with respect to each such drug— 
‘‘(aa) the brand name, ge-
neric or non-proprietary name, 
and National Drug Code; 
‘‘(bb) the number of plan 
enrollees for whom the drug was 
dispensed, the total number of 
prescription claims for the drug 
(including original prescriptions 
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and refills, counted as separate 
claims), and the total number of 
dosage units of the drug dis-
pensed; 
‘‘(cc) the number of pre-
scription claims described in item 
(bb) by each type of dispensing 
channel through which the drug 
was dispensed, including retail, 
mail order, specialty pharmacy, 
long term care pharmacy, home 
infusion pharmacy, or other types 
of pharmacies or providers; 
‘‘(dd) the average wholesale 
acquisition cost, listed as cost per 
day’s supply, cost per dosage 
unit, and cost per typical course 
of treatment (as applicable); 
‘‘(ee) the average wholesale 
price for the drug, listed as cost 
per day’s supply, cost per dosage 
unit, and cost per typical course 
of treatment (as applicable); 
‘‘(ff) the total out-of-pocket 
spending by plan enrollees on 
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such drug after application of 
any benefits under the plan, in-
cluding plan enrollee spending 
through copayments, coinsurance, 
and deductibles; 
‘‘(gg) total rebates paid by 
the manufacturer on the drug as 
reported under the Detailed DIR 
Report (or any successor report) 
submitted by such sponsor to the 
Centers for Medicare & Medicaid 
Services; 
‘‘(hh) all other direct or in-
direct remuneration on the drug 
as reported under the Detailed 
DIR Report (or any successor re-
port) submitted by such sponsor 
to the Centers for Medicare & 
Medicaid Services; 
‘‘(ii) the average pharmacy 
reimbursement amount paid by 
the plan for the drug in the ag-
gregate and disaggregated by dis-
pensing channel identified in item 
(cc); 
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‘‘(jj) the average National 
Average Drug Acquisition Cost 
(NADAC); and 
‘‘(kk) total manufacturer-de-
rived revenue, inclusive of bona 
fide service fees, attributable to 
the drug and retained by the 
pharmacy benefit manager and 
any affiliate of such pharmacy 
benefit manager. 
‘‘(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 
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of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are not an affiliate of the 
pharmacy benefit manager and 
that are included in the phar-
macy network of such plan. 
‘‘(cc) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
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 
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in the pharmacy network of such 
plan. 
‘‘(ee) The difference between 
the average acquisition cost of 
the affiliate, such as a pharmacy 
or other entity that acquires pre-
scription drugs, that initially ac-
quires the drug and the amount 
reported under subclause (I)(jj) 
for each drug. 
‘‘(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. 
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‘‘(cc) Where a generic drug 
listed under item (aa) is on a for-
mulary tier typically associated 
with higher cost-sharing than the 
listed drug, the estimated aver-
age cost-sharing that a bene-
ficiary would have paid for a 30- 
day supply of each of the generic 
drugs described in item (aa), had 
the plan provided coverage for 
such drugs on the same for-
mulary tier as the listed drug. 
‘‘(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. 
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‘‘(IV) Where a reference product 
(as defined in section 351(i) of the 
Public Health Service Act) is covered 
by the plan, the following information: 
‘‘(aa) A list of currently 
marketed 
biosimilar 
biological 
products licensed under section 
351(k) of the Public Health 
Service Act pursuant to an appli-
cation that refers to such ref-
erence product that are not cov-
ered by the plan, are covered on 
the same formulary tier or a for-
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 
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(aa) is on a formulary tier typi-
cally associated with higher cost- 
sharing than the listed drug, the 
estimated average cost-sharing 
that a beneficiary would have 
paid for a 30-day supply of each 
of the biosimilar biological prod-
ucts described in item (aa), had 
the plan provided coverage for 
such products on the same for-
mulary tier as the reference prod-
uct. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the reference product 
than the biosimilar biological 
product described in item (aa). 
‘‘(ee) The number of cur-
rently marketed biosimilar bio-
logical products licensed under 
section 351(k) of the Public 
Health Service Act, pursuant to 
an application that refers to such 
reference product. 
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‘‘(V) Total gross spending on 
covered part D drugs by the plan, not 
net of rebates, fees, discounts, or 
other direct or indirect remuneration. 
‘‘(VI) The total amount retained 
by the pharmacy benefit manager or 
an affiliate of such pharmacy benefit 
manager in revenue related to utiliza-
tion of covered part D drugs under 
that plan, inclusive of bona fide serv-
ice fees. 
‘‘(VII) The total spending on cov-
ered part D drugs net of rebates, fees, 
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: 
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‘‘(aa) A list of all brokers, 
consultants, advisors, and audi-
tors that receive compensation 
from the pharmacy benefit man-
ager or an affiliate of such phar-
macy benefit manager for refer-
rals, 
consulting, 
auditing, 
or 
other services offered to PDP 
sponsors related to pharmacy 
benefit management services. 
‘‘(bb) The amount of com-
pensation provided by such phar-
macy benefit manager or affiliate 
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-
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veloped by the Secretary that includes 
such information described in sub-
clauses (I) through (X). 
‘‘(ii) WRITTEN EXPLANATION OF CON-
TRACTS
OR
AGREEMENTS
WITH
DRUG 
MANUFACTURERS.— 
‘‘(I) IN
GENERAL.—The phar-
macy benefit manager shall, not later 
than 30 days after the finalization of 
any contract or agreement between 
such pharmacy benefit manager or an 
affiliate of such pharmacy benefit 
manager and a drug manufacturer (or 
subsidiary, agent, or entity affiliated 
with such drug manufacturer) that 
makes rebates, discounts, payments, 
or other financial incentives related to 
one or more covered part D drugs or 
other prescription drugs, as applica-
ble, of the manufacturer directly or 
indirectly contingent upon coverage, 
formulary placement, or utilization 
management conditions on any other 
covered part D drugs or other pre-
scription drugs, as applicable, submit 
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to the PDP sponsor a written expla-
nation of such contract or agreement. 
‘‘(II) REQUIREMENTS.—A writ-
ten explanation under subclause (I) 
shall— 
‘‘(aa) include the manufac-
turer subject to the contract or 
agreement, all covered part D 
drugs 
and 
other 
prescription 
drugs, as applicable, subject to 
the contract or agreement and 
the manufacturers of such drugs, 
and a high-level description of 
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, 
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who reports directly to the offi-
cer. 
‘‘(III) DEFINITION
OF
OTHER 
PRESCRIPTION DRUGS.—For purposes 
of this clause, the term ‘other pre-
scription drugs’ means prescription 
drugs covered as supplemental bene-
fits under this part or prescription 
drugs paid outside of this part. 
‘‘(D) AUDIT RIGHTS.— 
‘‘(i) IN GENERAL.—Not less than once 
a year, at the request of the PDP sponsor, 
the pharmacy benefit manager shall allow 
for an audit of the pharmacy benefit man-
ager to ensure compliance with all terms 
and conditions under the written agree-
ment and the accuracy of information re-
ported 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 
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available to such auditor all records, data, 
contracts, and other information necessary 
to confirm the accuracy of information 
provided under subparagraph (C), subject 
to reasonable restrictions on how such in-
formation must be reported to prevent re-
disclosure of such information. 
‘‘(iv) TIMING.—The pharmacy benefit 
manager must provide information under 
clause (iii) and other information, data, 
and records relevant to the audit to such 
auditor within 6 months of the initiation of 
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) that is owned or 
held by an affiliate of such pharmacy ben-
efit manager. 
‘‘(2) ENFORCEMENT.— 
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‘‘(A) IN
GENERAL.—Each PDP sponsor 
shall— 
‘‘(i) disgorge to the Secretary any 
amounts disgorged to the PDP sponsor by 
a pharmacy benefit manager under para-
graph (1)(A)(v); 
‘‘(ii) require, in a written agreement 
with any pharmacy benefit manager acting 
on behalf of such sponsor or affiliate of 
such pharmacy benefit manager, that such 
pharmacy benefit manager or affiliate re-
imburse the PDP sponsor for any civil 
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 
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with the requirements applicable under 
paragraph (1). 
‘‘(B) REPORTING
OF
ALLEGED
VIOLA-
TIONS.—The Secretary shall make available and 
maintain a mechanism for manufacturers, PDP 
sponsors, pharmacies, and other entities that 
have contractual relationships with pharmacy 
benefit managers or affiliates of such pharmacy 
benefit managers to report, on a confidential 
basis, alleged violations of paragraph (1)(A) or 
subparagraph (C). 
‘‘(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 (in a time and 
manner specified by the Secretary) an annual 
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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 prohibiting pay-
ments related to reimbursement for ingredient costs 
to any entity that acquires prescription drugs, such 
as a pharmacy or wholesaler. 
‘‘(5) STANDARD FORMATS.— 
‘‘(A) IN GENERAL.—Not later than June 
1, 2026, 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 
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a pharmacy benefit manager, a PDP sponsor, 
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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(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 any entity that is owned by, controlled 
by, or related under a common ownership struc-
ture with a pharmacy benefit manager or PDP 
sponsor, or that acts as a contractor or agent 
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to such pharmacy benefit manager or PDP 
sponsor, insofar as such contractor or agent 
performs any of the functions described under 
subparagraph (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) for a bona fide, itemized service ac-
tually performed on behalf of an entity, that the 
entity would otherwise perform (or contract for) 
in the absence of the service arrangement and 
that is not passed on in whole or in part to a 
client or customer, whether or not the entity 
takes title to the drug. Such fee must be a flat 
dollar amount and shall not be directly or indi-
rectly based on, or contingent upon— 
‘‘(i) drug price, such as wholesale ac-
quisition cost or drug benchmark price 
(such as average wholesale price); 
‘‘(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); 
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‘‘(iii) coverage or formulary placement 
decisions or the volume or value of any re-
ferrals or business generated between the 
parties to the arrangement; or 
‘‘(iv) any other amounts or meth-
odologies prohibited by the Secretary. 
‘‘(C) PHARMACY BENEFIT MANAGER.—The 
term ‘pharmacy benefit manager’ means any 
person or entity that, either directly or through 
an intermediary, acts as a price negotiator or 
group purchaser on behalf of a PDP sponsor or 
prescription drug plan, or manages the pre-
scription drug benefits provided by such spon-
sor or plan, including the processing and pay-
ment of claims for prescription drugs, the per-
formance of drug utilization review, the proc-
essing of drug prior authorization requests, the 
adjudication of appeals or grievances related to 
the prescription drug benefit, contracting with 
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 
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of whether such person or entity calls itself a 
‘pharmacy benefit manager’.’’. 
(2) MA–PD PLANS.—Section 1857(f)(3) of the 
Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(F) REQUIREMENTS RELATING TO PHAR-
MACY BENEFIT MANAGERS.—For plan years be-
ginning on or after January 1, 2027, section 
1860D–12(h).’’. 
(3) NONAPPLICATION OF PAPERWORK REDUC-
TION ACT.—Chapter 35 of title 44, United States 
Code, shall not apply to the implementation of this 
subsection. 
(4) FUNDING.— 
(A) SECRETARY.—In addition to amounts 
otherwise available, there is appropriated to the 
Centers for Medicare & Medicaid Services Pro-
gram Management Account, out of any money 
in the Treasury not otherwise appropriated, 
$113,000,000 for fiscal year 2025, to remain 
available until expended, to carry out this sub-
section. 
(B) OIG.—In addition to amounts other-
wise available, there is appropriated to the In-
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spector General of the Department of Health 
and Human Services, out of any money in the 
Treasury 
not 
otherwise 
appropriated, 
$20,000,000 for fiscal year 2025, to remain 
available until expended, to carry out this sub-
section. 
(b) GAO STUDY AND REPORT ON CERTAIN REPORT-
ING REQUIREMENTS.— 
(1) STUDY.—The Comptroller General of the 
United States (in this subsection referred to as the 
‘‘Comptroller General’’) shall conduct a study on 
Federal and State reporting requirements for health 
plans and pharmacy benefit managers related to the 
transparency of prescription drug costs and prices. 
Such study shall include an analysis of the following: 
(A) Federal statutory and regulatory re-
porting requirements for health plans and phar-
macy benefit managers related to prescription 
drug costs and prices. 
(B) Selected States’ statutory and regu-
latory reporting requirements for health plans 
and pharmacy benefit managers related to pre-
scription drug costs and prices. 
(C) The extent to which the statutory and 
regulatory reporting requirements identified in 
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subparagraphs (A) and (B) overlap and con-
flict. 
(D) The resources required by health plans 
and pharmacy benefit managers to comply with 
the reporting requirements described in sub-
paragraphs (A) and (B). 
(E) Other items determined appropriate by 
the Comptroller General. 
(2) REPORT.—Not later than 2 years after the 
date on which information is first required to be re-
ported under section 1860D–12(h)(1)(C) of the So-
cial Security Act, as added by subsection (a)(1), the 
Comptroller General shall submit to Congress a re-
port containing the results of the study conducted 
under paragraph (1), together with recommenda-
tions for legislation and administrative actions that 
would streamline and reduce the burden associated 
with the reporting requirements for health plans and 
pharmacy benefit managers described in paragraph 
(1). 
(c) MEDPAC REPORTS
ON AGREEMENTS WITH 
PHARMACY BENEFIT MANAGERS WITH RESPECT TO PRE-
SCRIPTION DRUG PLANS
AND MA–PD PLANS.—The 
Medicare Payment Advisory Commission shall submit to 
Congress the following reports: 
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(1) Not later than March 31, 2028, a report re-
garding agreements with pharmacy benefit managers 
with respect to prescription drug plans and MA–PD 
plans. Such report shall include— 
(A) a description of trends and patterns, 
including relevant averages, totals, and other 
figures for each of the types of information sub-
mitted; 
(B) an analysis of any differences in agree-
ments and their effects on plan enrollee out-of- 
pocket spending and average pharmacy reim-
bursement, and any other impacts; and 
(C) any recommendations the Commission 
determines appropriate. 
(2) Not later than March 31, 2030, a report de-
scribing any changes with respect to the information 
described in paragraph (1) over time, together with 
any recommendations the Commission determines 
appropriate. 
SEC. 303. EXTENDING THE ADJUSTMENT TO THE CALCULA-
TION OF HOSPICE CAP AMOUNTS UNDER THE 
MEDICARE PROGRAM. 
Section 1814(i)(2)(B) of the Social Security Act (42 
U.S.C. 1395f(i)(2)(B)) is amended— 
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