IB 

Union Calendar No. 786 

118TH CONGRESS 

2D SESSION H. R. 8261 

[Report No. 118–891, Part I] 

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 committee concerned 

DECEMBER 17, 2024 

Reported from the Committee on Ways and Means with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

DECEMBER 17, 2024 

Referral to the Committee on Energy and Commerce extended for a period 

ending not later than December 19, 2024 

DECEMBER 19, 2024 

Committee on Energy and Commerce discharged; committed to the Committee 

of the Whole House on the State of the Union and ordered to be printed 

[For text of introduced bill, see copy of bill as introduced on May 7, 2024] 


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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. 


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1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Preserving Telehealth, 

5 Hospital, and Ambulance Access Act’’. 

6 TITLE I—PRESERVING PA7 TIENTS’ ACCESS TO CARE IN 

8 THE HOME 

9 SEC. 101. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILI10 TIES. 

11 (a) REMOVING GEOGRAPHIC REQUIREMENTS AND EX12 PANDING ORIGINATING SITES FOR TELEHEALTH SERV13 ICES.—Section 1834(m) of the Social Security Act (42 

14 U.S.C. 1395m(m)) is amended— 

15 (1) in paragraph (2)(B)(iii), by striking ‘‘ending 

16 December 31, 2024’’ and inserting ‘‘ending December 

17 31, 2026’’; and 

18 (2) in paragraph (4)(C)(iii), by striking ‘‘ending 

19 on December 31, 2024’’ and inserting ‘‘ending on De20 cember 31, 2026’’. 

21 (b) EXPANDING PRACTITIONERS ELIGIBLE TO FUR22 NISH TELEHEALTH SERVICES.—Section 1834(m)(4)(E) of 

23 the Social Security Act (42 U.S.C. 1395m(m)(4)(E)) is 

24 amended by striking ‘‘ending on December 31, 2024’’ and 

25 inserting ‘‘ending on December 31, 2026’’. 


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1 (c) EXTENDING TELEHEALTH SERVICES FOR FEDER2 ALLY QUALIFIED HEALTH CENTERS AND RURAL HEALTH

3 CLINICS.—Section 1834(m)(8)(A) of the Social Security 

4 Act (42 U.S.C. 1395m(m)(8)(A)) is amended by striking 

5 ‘‘ending on December 31, 2024’’ and inserting ‘‘ending on 

6 December 31, 2026’’. 

7 (d) DELAYING THE IN-PERSON REQUIREMENTS

8 UNDER MEDICARE FOR MENTAL HEALTH SERVICES FUR9 NISHED THROUGH TELEHEALTH AND TELECOMMUNI10 CATIONS TECHNOLOGY.— 

11 (1) DELAY IN REQUIREMENTS FOR MENTAL

12 HEALTH SERVICES FURNISHED THROUGH TELE13 HEALTH.—Section 1834(m)(7)(B)(i) of the Social Se14 curity Act (42 U.S.C. 1395m(m)(7)(B)(i)) is amend15 ed, in the matter preceding subclause (I), by striking 

16 ‘‘on or after’’ and all that follows through ‘‘described 

17 in section 1135(g)(1)(B))’’ and inserting ‘‘on or after 

18 January 1, 2027’’. 

19 (2) MENTAL HEALTH VISITS FURNISHED BY

20 RURAL HEALTH CLINICS.—Section 1834(y)(2) of the 

21 Social Security Act (42 U.S.C. 1395m(y)(2)) is 

22 amended by striking ‘‘January 1, 2025’’ and all that 

23 follows through the period at the end and inserting 

24 ‘‘January 1, 2027.’’. 


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1 (3) MENTAL HEALTH VISITS FURNISHED BY FED2 ERALLY QUALIFIED HEALTH CENTERS.—Section 

3 1834(o)(4)(B) of the Social Security Act (42 U.S.C. 

4 1395m(o)(4)(B)) is amended by striking ‘‘January 1, 

5 2025’’ and all that follows through the period at the 

6 end and inserting ‘‘January 1, 2027.’’. 

7 (e) ALLOWING FOR THE FURNISHING OF AUDIO-ONLY

8 TELEHEALTH SERVICES.—Section 1834(m)(9) of the Social 

9 Security Act (42 U.S.C. 1395m(m)(9)) is amended by strik10 ing ‘‘ending on December 31, 2024’’ and inserting ‘‘ending 

11 on December 31, 2026’’. 

12 (f) EXTENDING USE OF TELEHEALTH TO CONDUCT

13 FACE-TO-FACE ENCOUNTER PRIOR TO RECERTIFICATION

14 OF ELIGIBILITY FOR HOSPICE CARE.—Section 

15 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 

16 1395f(a)(7)(D)(i)(II)) is amended— 

17 (1) by striking ‘‘ending on December 31, 2024’’ 

18 and inserting ‘‘ending on December 31, 2026’’; and 

19 (2) by inserting ‘‘, except that this subclause 

20 shall not apply in the case of such an encounter with 

21 an individual occurring on or after January 1, 2025, 

22 if such individual is located in an area that is subject 

23 to a moratorium on the enrollment of hospice pro24 grams under this title pursuant to section 1866(j)(7), 

25 if such individual is receiving hospice care from a 


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1 provider that is subject to enhanced oversight under 

2 this title pursuant to section 1866(j)(3), or if such en3 counter is performed by a hospice physician or nurse 

4 practitioner who is not enrolled under section 1866(j) 

5 and is not an opt-out physician or practitioner (as 

6 defined in section 1802(b)(6)(D))’’ before the semi7 colon. 

8 (g) PROGRAM INSTRUCTION AUTHORITY.—The Sec9 retary of Health and Human Services may implement the 

10 amendments made by this section through program instruc11 tion or otherwise. 

12 SEC. 102. GUIDANCE ON FURNISHING SERVICES VIA TELE13 HEALTH TO INDIVIDUALS WITH LIMITED 

14 ENGLISH PROFICIENCY. 

15 (a) IN GENERAL.—Not later than 1 year after the date 

16 of the enactment of this section, the Secretary of Health and 

17 Human Services, in consultation with 1 or more entities 

18 from each of the categories described in paragraphs (1) 

19 through (7) of subsection (b), shall issue and disseminate, 

20 or update and revise as applicable, guidance for the entities 

21 described in such subsection on the following: 

22 (1) Best practices on facilitating and integrating 

23 use of interpreters during a telemedicine appoint24 ment. 


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1 (2) Best practices on providing accessible in2 structions on how to access telecommunications sys3 tems (as such term is used for purposes of section 

4 1834(m) of the Social Security Act (42 U.S.C. 

5 1395m(m)) for individuals with limited English pro6 ficiency. 

7 (3) Best practices on improving access to digital 

8 patient portals for individuals with limited English 

9 proficiency. 

10 (4) Best practices on integrating the use of video 

11 platforms that enable multi-person video calls fur12 nished via a telecommunications system for purposes 

13 of providing interpretation during a telemedicine ap14 pointment for an individual with limited English 

15 proficiency. 

16 (5) Best practices for providing patient mate17 rials, communications, and instructions in multiple 

18 languages, including text message appointment re19 minders and prescription information. 

20 (b) ENTITIES DESCRIBED.—For purposes of subsection 

21 (a), an entity described in this subsection is an entity in 

22 1 or more of the following categories: 

23 (1) Health information technology service pro24 viders, including— 

25 (A) electronic medical record companies; 


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1 (B) remote patient monitoring companies; 

2 and 

3 (C) telehealth or mobile health vendors and 

4 companies. 

5 (2) Health care providers, including— 

6 (A) physicians; and 

7 (B) hospitals. 

8 (3) Health insurers. 

9 (4) Language service companies. 

10 (5) Interpreter or translator professional associa11 tions. 

12 (6) Health and language services quality certifi13 cation organizations. 

14 (7) Patient and consumer advocates, including 

15 such advocates that work with individuals with lim16 ited English proficiency. 

17 SEC. 103. ESTABLISHMENT OF MODIFIER FOR RECERTIFI18 CATIONS OF HOSPICE CARE ELIGIBILITY 

19 CONDUCTED THROUGH TELEHEALTH. 

20 Section 1814(a)(7)(D)(i)(II) of the Social Security Act 

21 (42 U.S.C. 1395f(a)(7)(D)(i)(II)), as amended by section 

22 101(f), is further amended by inserting ‘‘, provided that, 

23 in the case of such an encounter occurring on or after the 

24 date that is 2 years after the date of the enactment of the 

25 ‘Preserving Telehealth, Hospital, and Ambulance Access 


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1 Act’, such physician or nurse practitioner includes in any 

2 claim for such encounter one or more modifiers or codes 

3 specified by the Secretary to indicate that such encounter 

4 was furnished through telehealth’’ after ‘‘as determined ap5 propriate by the Secretary’’. 

6 SEC. 104. EXTENDING ACUTE HOSPITAL CARE AT HOME 

7 WAIVER FLEXIBILITIES. 

8 Section 1866G of the Social Security Act (42 U.S.C. 

9 1395cc–7) is amended— 

10 (1) in subsection (a)(1), by striking ‘‘2024’’ and 

11 inserting ‘‘2029’’; and 

12 (2) in subsection (b)— 

13 (A) in the header, by striking ‘‘STUDY AND

14 REPORT’’ and inserting ‘‘STUDIES AND RE15 PORTS’’; 

16 (B) in paragraph (1)— 

17 (i) in the matter preceding subpara18 graph (A), by striking ‘‘The Secretary’’ and 

19 inserting ‘‘Not later than September 30, 

20 2024, and again not later than September 

21 30, 2028, the Secretary’’; 

22 (ii) in clause (iv), by striking ‘‘and’’ at 

23 the end; 

24 (iii) in clause (v), by striking the pe25 riod and inserting ‘‘; and’’; and 


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1 (iv) by adding at the end the following 

2 new clause: 

3 ‘‘(vi) in the case of the second study 

4 conducted under this paragraph, the quality 

5 of care, outcomes, costs, quantity and inten6 sity of services, and other relevant metrics 

7 between individuals who entered into the 

8 Acute Hospital Care at Home initiative di9 rectly from an emergency department com10 pared with individuals who entered into the 

11 Acute Hospital Care at Home initiative di12 rectly from an existing inpatient stay in a 

13 hospital.’’; and 

14 (C) in paragraph (2)— 

15 (i) in the header, by striking ‘‘RE16 PORT’’ and inserting ‘‘REPORTS’’; and 

17 (ii) by inserting ‘‘and again not later 

18 than September 30, 2028,’’ after ‘‘2024,’’; 

19 and 

20 (iii) by striking ‘‘on the study con21 ducted under paragraph (1).’’ and inserting 

22 the following: ‘‘on— 

23 ‘‘(A) with respect to the first report sub24 mitted under this paragraph, the first study con25 ducted under paragraph (1); and 


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1 ‘‘(B) with respect to the second report sub2 mitted under this paragraph, the second study 

3 conducted under paragraph (1).’’. 

4 SEC. 105. REPORT ON WEARABLE MEDICAL DEVICES. 

5 Not later than 18 months after the date of the enact6 ment of this Act, the Comptroller General of the United 

7 States shall conduct a technology assessment of, and submit 

8 to Congress a report on, the capabilities and limitations 

9 of wearable medical devices used to support clinical deci10 sion-making. Such report shall include a description of— 

11 (1) the potential for such devices to accurately 

12 prescribe treatments; 

13 (2) an examination of the benefits and challenges 

14 of artificial intelligence to augment such capabilities; 

15 and 

16 (3) policy options to enhance the benefits and 

17 mitigate potential challenges of developing or using 

18 such devices. 

19 SEC. 106. ENHANCING CERTAIN PROGRAM INTEGRITY RE20 QUIREMENTS FOR DME UNDER MEDICARE. 

21 (a) DURABLE MEDICAL EQUIPMENT.—Section 

22 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) 

23 is amended by adding at the end the following new para24 graph: 


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1 ‘‘(23) MASTER LIST INCLUSION AND CLAIM RE2 VIEW FOR CERTAIN ITEMS.— 

3 ‘‘(A) MASTER LIST INCLUSION.—Beginning 

4 January 1, 2027, for purposes of the Master List 

5 described in section 414.234(b) of title 42, Code 

6 of Federal Regulations (or any successor regula7 tion), an item for which payment may be made 

8 under this subsection shall be treated as having 

9 aberrant billing patterns (as such term is used 

10 for purposes of such section) if the Secretary de11 termines that, without explanatory contributing 

12 factors (such as furnishing emergent care serv13 ices), a substantial number of claims for such 

14 items under this subsection are from an ordering 

15 physician or practitioner with whom the indi16 vidual involved does not have a prior relation17 ship, as determined on the basis of claims. 

18 ‘‘(B) CLAIM REVIEW.—With respect to items 

19 furnished on or after January 1, 2027 that are 

20 included on the Master List pursuant to sub21 paragraph (A), if such an item is not subject to 

22 a determination of coverage in advance pursuant 

23 to paragraph (15)(C), the Secretary may conduct 

24 prepayment review of claims for payment for 

25 such item.’’. 


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1 (b) REPORT ON IDENTIFYING CLINICAL DIAGNOSTIC

2 LABORATORY TESTS AT HIGH RISK FOR FRAUD AND EF3 FECTIVE MITIGATION MEASURES.—Not later than January 

4 1, 2026, the Inspector General of the Department of Health 

5 and Human Services shall submit to Congress a report as6 sessing fraudulent claims for clinical diagnostic laboratory 

7 tests for which payment may be made under section 1834A 

8 of the Social Security Act (42 U.S.C. 1395m–1) and effec9 tive tools for reducing such fraudulent claims. The report 

10 shall include— 

11 (1) which, if any, clinical diagnostic laboratory 

12 tests are identified as being at high risk of fraudulent 

13 claims, and an analysis of the factors that contribute 

14 to such risk; 

15 (2) with respect to a clinical diagnostic labora16 tory test identified under subparagraph (A) as being 

17 at high risk of fraudulent claims— 

18 (A) the amount payable under such section 

19 1834A with respect to such test; 

20 (B) the number of such tests furnished to 

21 individuals enrolled under part B of title XVIII 

22 of the Social Security Act (42 U.S.C. 1395j et 

23 seq.); 

24 (C) whether an order for such a test was 

25 more likely to come from a provider with whom 


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1 the individual involved did not have a prior re2 lationship, as determined on the basis of prior 

3 payment experience; and 

4 (D) the frequency with which a claim for 

5 payment under such section 1834A included the 

6 payment modifier identified by code 59 or 91; 

7 and 

8 (3) suggested strategies for reducing the number 

9 of fraudulent claims made with respect to tests so 

10 identified as being at high risk, including— 

11 (A) an analysis of whether the Centers for 

12 Medicare & Medicaid Services can detect aber13 rant billing patterns with respect to such tests in 

14 a timely manner; 

15 (B) any strategies for identifying and mon16 itoring the providers who are outliers with re17 spect to the number of such tests that such pro18 viders order; and 

19 (C) targeted education efforts to mitigate 

20 improper billing for such tests. 


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1 TITLE II—SUSTAINING ACCESS 

2 TO HOSPITAL AND EMER3 GENCY SERVICES 

4 SEC. 201. EXTENSION OF INCREASED INPATIENT HOSPITAL 

5 PAYMENT ADJUSTMENT FOR CERTAIN LOW6 VOLUME HOSPITALS. 

7 (a) IN GENERAL.—Section 1886(d)(12) of the Social 

8 Security Act (42 U.S.C. 1395ww(d)(12)) is amended— 

9 (1) in subparagraph (B), by striking ‘‘during the 

10 portion of fiscal year 2025 beginning on January 1, 

11 2025, and ending on September 30, 2025, and’’; 

12 (2) in subparagraph (C)(i)— 

13 (A) in the matter preceding subclause (I)— 

14 (i) by striking ‘‘or portion of a fiscal 

15 year’’; and 

16 (ii) by striking ‘‘2024 and the portion 

17 of fiscal year 2025 beginning on October 1, 

18 2024, and ending on December 31, 2024’’ 

19 and inserting ‘‘2025’’; 

20 (B) in subclause (III), by striking ‘‘2024 

21 and the portion of fiscal year 2025 beginning on 

22 October 1, 2024, and ending on December 31, 

23 2024’’ and inserting ‘‘2025’’; and 

24 (C) in subclause (IV), by striking ‘‘the por25 tion of fiscal year 2025 beginning on January 1, 


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1 2025, and ending on September 30, 2025, and’’; 

2 and 

3 (3) in subparagraph (D)— 

4 (A) in the matter preceding clause (i), by 

5 striking ‘‘2024 or during the portion of fiscal 

6 year 2025 beginning on October 1, 2024, and 

7 ending on December 31, 2024’’ and inserting 

8 ‘‘2025’’; and 

9 (B) in clause (ii), by striking ‘‘ 2024 and 

10 the portion of fiscal year 2025 beginning on Oc11 tober 1, 2024, and ending on December 31, 

12 2024’’ and inserting ‘‘2025’’. 

13 (b) IMPLEMENTATION.—Notwithstanding any other 

14 provision of law, the Secretary of Health and Human Serv15 ices may implement the provisions of, including the amend16 ments made by, this section by program instruction or oth17 erwise. 

18 SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOS19 PITAL PROGRAM. 

20 (a) IN GENERAL.—Section 1886(d)(5)(G) of the Social 

21 Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amended— 

22 (1) in clause (i), by striking ‘‘January 1, 2025’’ 

23 and inserting ‘‘October 1, 2025’’; and 

24 (2) in clause (ii)(II), by striking ‘‘January 1, 

25 2025’’ and inserting ‘‘October 1, 2025’’. 


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1 (b) CONFORMING AMENDMENTS.— 

2 (1) EXTENSION OF TARGET AMOUNT.—Section 

3 1886(b)(3)(D) of the Social Security Act (42 U.S.C. 

4 1395ww(b)(3)(D)) is amended— 

5 (A) in the matter preceding clause (i), by 

6 striking ‘‘January 1, 2025’’ and inserting ‘‘Octo7 ber 1, 2025’’; and 

8 (B) in clause (iv), by striking ‘‘2024 and 

9 the portion of fiscal year 2025 beginning on Oc10 tober 1, 2024, and ending on December 31, 

11 2024’’ and inserting ‘‘2025’’. 

12 (2) PERMITTING HOSPITALS TO DECLINE RE13 CLASSIFICATION.—Section 13501(e)(2) of the Omni14 bus Budget Reconciliation Act of 1993 (42 U.S.C. 

15 1395ww note) is amended by striking ‘‘2024, or the 

16 portion of fiscal year 2025 beginning on October 1, 

17 2024, and ending on December 31, 2024’’ and insert18 ing ‘‘2025’’. 

19 SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBU20 LANCE SERVICES. 

21 (a) IN GENERAL.—Section 1834(l) of the Social Secu22 rity Act (42 U.S.C. 1395m(l)) is amended— 

23 (1) in paragraph (12)(A), by striking ‘‘January 

24 1, 2025’’ and inserting ‘‘October 1, 2025’’; and 


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1 (2) in paragraph (13), by striking ‘‘January 1, 

2 2025’’ in each place it appears and inserting ‘‘Octo3 ber 1, 2025’’ in each such place. 

4 (b) PROGRAM INSTRUCTION AUTHORITY.—Notwith5 standing any other provision of law, the Secretary of 

6 Health and Human Services may implement the provisions 

7 of, including amendments made by, this section through 

8 program instruction or otherwise. 

9 TITLE III—OFFSETS 

10 SEC. 301. REVISING PHASE-IN OF MEDICARE CLINICAL LAB11 ORATORY TEST PAYMENT CHANGES. 

12 (a) REVISED PHASE-IN OF REDUCTIONS FROM PRI13 VATE PAYOR RATE IMPLEMENTATION.—Section 

14 1834A(b)(3) of the Social Security Act (42 U.S.C. 1395m– 

15 1(b)(3)) is amended— 

16 (1) in subparagraph (A), by striking ‘‘2027’’ and 

17 inserting ‘‘2028’’; and 

18 (2) in subparagraph (B)— 

19 (A) in clause (ii), by striking ‘‘2024’’ and 

20 inserting ‘‘2025’’; and 

21 (B) in clause (iii), by striking ‘‘2025 

22 through 2027’’ and inserting ‘‘2026 through 

23 2028’’. 

24 (b) REVISED REPORTING PERIOD FOR REPORTING OF

25 PRIVATE SECTOR PAYMENT RATES FOR ESTABLISHMENT


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1 OF MEDICARE PAYMENT RATES.—Section 1834A(a)(1)(B) 

2 of the Social Security Act (42 U.S.C. 1395m–1(a)(1)(B)) 

3 is amended— 

4 (1) in clause (i), by striking ‘‘2024’’ and insert5 ing ‘‘2025’’; and 

6 (2) in clause (ii), by striking ‘‘2025’’ each place 

7 it appears and inserting ‘‘2026’’. 

8 (c) IMPLEMENTATION.—The Secretary of Health and 

9 Human Services may implement the amendments made by 

10 this section by program instruction or otherwise. 

11 SEC. 302. ARRANGEMENTS WITH PHARMACY BENEFIT MAN12 AGERS WITH RESPECT TO PRESCRIPTION 

13 DRUG PLANS AND MA–PD PLANS. 

14 (a) IN GENERAL.— 

15 (1) PRESCRIPTION DRUG PLANS.—Section 

16 1860D–12 of the Social Security Act (42 U.S.C. 

17 1395w–112) is amended by adding at the end the fol18 lowing new subsection: 

19 ‘‘(h) REQUIREMENTS RELATING TO PHARMACY BEN20 EFIT MANAGERS.—For plan years beginning on or after 

21 January 1, 2027: 

22 ‘‘(1) AGREEMENTS WITH PHARMACY BENEFIT

23 MANAGERS.—Each contract entered into with a PDP 

24 sponsor under this part with respect to a prescription 

25 drug plan offered by such sponsor shall provide that 


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1 any pharmacy benefit manager acting on behalf of 

2 such sponsor has a written agreement with the PDP 

3 sponsor under which the pharmacy benefit manager, 

4 and any affiliates of such pharmacy benefit manager, 

5 as applicable, agree to meet the following require6 ments: 

7 ‘‘(A) NO INCOME OTHER THAN BONA FIDE

8 SERVICE FEES.— 

9 ‘‘(i) IN GENERAL.—The pharmacy ben10 efit manager and any affiliate of such phar11 macy benefit manager shall not derive any 

12 remuneration with respect to any services 

13 provided on behalf of any entity or indi14 vidual, in connection with the utilization of 

15 covered part D drugs, from any such entity 

16 or individual other than bona fide service 

17 fees, subject to clauses (ii) and (iii). 

18 ‘‘(ii) INCENTIVE PAYMENTS.—For the 

19 purposes of this subsection, an incentive 

20 payment paid by a PDP sponsor to a phar21 macy benefit manager that is performing 

22 services on behalf of such sponsor shall be 

23 deemed a ‘bona fide service fee’(even if such 

24 payment does not otherwise meet the defini25 tion of such term under paragraph (7)(B)) 


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1 if such payment is a flat dollar amount, is 

2 consistent with fair market value (as speci3 fied by the Secretary), is related to services 

4 actually performed by the pharmacy benefit 

5 manager or affiliate of such pharmacy ben6 efit manager, on behalf of the entity making 

7 such payment, in connection with the utili8 zation of covered part D drugs, and meets 

9 additional requirements, if any, as deter10 mined appropriate by the Secretary. 

11 ‘‘(iii) CLARIFICATION ON REBATES AND

12 DISCOUNTS USED TO LOWER COSTS FOR

13 COVERED PART D DRUGS.—Rebates, dis14 counts, and other price concessions received 

15 by a pharmacy benefit manager or an affil16 iate of a pharmacy benefit manager from 

17 manufacturers, even if such price conces18 sions are calculated as a percentage of a 

19 drug’s price, shall not be considered a viola20 tion of the requirements of clause (i) if they 

21 are fully passed through to a PDP sponsor 

22 and are compliant with all regulatory and 

23 subregulatory requirements related to direct 

24 and indirect remuneration for manufac25 turer rebates under this part, including in 


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1 cases where a PDP sponsor is acting as a 

2 pharmacy benefit manager on behalf of a 

3 prescription drug plan offered by such PDP 

4 sponsor. 

5 ‘‘(iv) EVALUATION OF REMUNERATION

6 ARRANGEMENTS.—Components of subsets of 

7 remuneration arrangements (such as fees or 

8 other forms of compensation paid to or re9 tained by the pharmacy benefit manager or 

10 affiliate of such pharmacy benefit manager), 

11 as determined appropriate by the Secretary, 

12 between pharmacy benefit managers or af13 filiates of such pharmacy benefit managers, 

14 as applicable, and other entities involved in 

15 the dispensing or utilization of covered part 

16 D drugs (including PDP sponsors, manu17 facturers, pharmacies, and other entities as 

18 determined appropriate by the Secretary) 

19 shall be subject to review by the Secretary, 

20 in consultation with the Office of the In21 spector General of the Department of Health 

22 and Human Services, as determined appro23 priate by the Secretary. The Secretary, in 

24 consultation with the Office of the Inspector 

25 General, shall review whether remuneration 


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1 under such arrangements is consistent with 

2 fair market value (as specified by the Sec3 retary) through reviews and assessments of 

4 such remuneration, as determined appro5 priate. 

6 ‘‘(v) DISGORGEMENT.—The pharmacy 

7 benefit manager shall disgorge any remu8 neration paid to such pharmacy benefit 

9 manager or an affiliate of such pharmacy 

10 benefit manager in violation of this sub11 paragraph to the PDP sponsor. 

12 ‘‘(vi) ADDITIONAL REQUIREMENTS.— 

13 The pharmacy benefit manager shall— 

14 ‘‘(I) enter into a written agree15 ment with any affiliate of such phar16 macy benefit manager, under which the 

17 affiliate shall identify and disgorge 

18 any remuneration described in clause 

19 (v) to the pharmacy benefit manager; 

20 and 

21 ‘‘(II) attest, subject to any re22 quirements determined appropriate by 

23 the Secretary, that the pharmacy ben24 efit manager has entered into a written 

25 agreement described in subclause (I) 


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1 with any relevant affiliate of the phar2 macy benefit manager. 

3 ‘‘(B) TRANSPARENCY REGARDING GUARAN4 TEES AND COST PERFORMANCE EVALUATIONS.— 

5 The pharmacy benefit manager shall— 

6 ‘‘(i) define, interpret, and apply, in a 

7 fully transparent and consistent manner for 

8 purposes of calculating or otherwise evalu9 ating pharmacy benefit manager perform10 ance against pricing guarantees or similar 

11 cost performance measurements related to 

12 rebates, discounts, price concessions, or net 

13 costs, terms such as— 

14 ‘‘(I) ‘generic drug’, in a manner 

15 consistent with the definition of the 

16 term under section 423.4 of title 42, 

17 Code of Federal Regulations, or a suc18 cessor regulation; 

19 ‘‘(II) ‘brand name drug’, in a 

20 manner consistent with the definition 

21 of the term under section 423.4 of title 

22 42, Code of Federal Regulations, or a 

23 successor regulation; 

24 ‘‘(III) ‘specialty drug’; 

25 ‘‘(IV) ‘rebate’; and 


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1 ‘‘(V) ‘discount’; 

2 ‘‘(ii) identify any drugs, claims, or 

3 price concessions excluded from any pricing 

4 guarantee or other cost performance calcula5 tion or evaluation in a clear and consistent 

6 manner; and 

7 ‘‘(iii) where a pricing guarantee or 

8 other cost performance measure is based on 

9 a pricing benchmark other than the whole10 sale acquisition cost (as defined in section 

11 1847A(c)(6)(B)) of a drug, calculate and 

12 provide a wholesale acquisition cost-based 

13 equivalent to the pricing guarantee or other 

14 cost performance measure in the written 

15 agreement. 

16 ‘‘(C) PROVISION OF INFORMATION.— 

17 ‘‘(i) IN GENERAL.—Not later than July 

18 1 of each year, beginning in 2027, the phar19 macy benefit manager shall submit to the 

20 PDP sponsor, and to the Secretary, a re21 port, in accordance with this subparagraph, 

22 and shall make such report available to 

23 such sponsor at no cost to such sponsor in 

24 a format specified by the Secretary under 

25 paragraph (5). Each such report shall inVerDate Sep 11 2014 20:14 Dec 27, 2024 Jkt 059200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6203 E:\BILLS\H8261.RH H8261

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1 clude, with respect to such PDP sponsor 

2 and each plan offered by such sponsor, the 

3 following information with respect to the 

4 previous plan year: 

5 ‘‘(I) A list of all drugs covered by 

6 the plan that were dispensed including, 

7 with respect to each such drug— 

8 ‘‘(aa) the brand name, ge9 neric or non-proprietary name, 

10 and National Drug Code; 

11 ‘‘(bb) the number of plan en12 rollees for whom the drug was dis13 pensed, the total number of pre14 scription claims for the drug (in15 cluding original prescriptions and 

16 refills, counted as separate 

17 claims), and the total number of 

18 dosage units of the drug dis19 pensed; 

20 ‘‘(cc) the number of prescrip21 tion claims described in item (bb) 

22 by each type of dispensing chan23 nel through which the drug was 

24 dispensed, including retail, mail 

25 order, specialty pharmacy, long 


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1 term care pharmacy, home infu2 sion pharmacy, or other types of 

3 pharmacies or providers; 

4 ‘‘(dd) the average wholesale 

5 acquisition cost, listed as cost per 

6 day’s supply, cost per dosage unit, 

7 and cost per typical course of 

8 treatment (as applicable); 

9 ‘‘(ee) the average wholesale 

10 price for the drug, listed as cost 

11 per day’s supply, cost per dosage 

12 unit, and cost per typical course 

13 of treatment (as applicable); 

14 ‘‘(ff) the total out-of-pocket 

15 spending by plan enrollees on 

16 such drug after application of any 

17 benefits under the plan, including 

18 plan enrollee spending through co19 payments, coinsurance, and 

20 deductibles; 

21 ‘‘(gg) total rebates paid by 

22 the manufacturer on the drug as 

23 reported under the Detailed DIR 

24 Report (or any successor report) 

25 submitted by such sponsor to the 


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1 Centers for Medicare & Medicaid 

2 Services; 

3 ‘‘(hh) all other direct or indi4 rect remuneration on the drug as 

5 reported under the Detailed DIR 

6 Report (or any successor report) 

7 submitted by such sponsor to the 

8 Centers for Medicare & Medicaid 

9 Services; 

10 ‘‘(ii) the average pharmacy 

11 reimbursement amount paid by 

12 the plan for the drug in the aggre13 gate and disaggregated by dis14 pensing channel identified in item 

15 (cc); 

16 ‘‘(jj) the average National 

17 Average Drug Acquisition Cost 

18 (NADAC); and 

19 ‘‘(kk) total manufacturer-de20 rived revenue, inclusive of bona 

21 fide service fees, attributable to the 

22 drug and retained by the phar23 macy benefit manager and any 

24 affiliate of such pharmacy benefit 

25 manager. 


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1 ‘‘(II) In the case of a pharmacy 

2 benefit manager that has an affiliate 

3 that is a retail, mail order, or spe4 cialty pharmacy, with respect to drugs 

5 covered by such plan that were dis6 pensed, the following information: 

7 ‘‘(aa) The percentage of total 

8 prescriptions that were dispensed 

9 by pharmacies that are an affil10 iate of the pharmacy benefit man11 ager for each drug. 

12 ‘‘(bb) The interquartile range 

13 of the total combined costs paid 

14 by the plan and plan enrollees, 

15 per dosage unit, per course of 

16 treatment, per 30-day supply, and 

17 per 90-day supply for each drug 

18 dispensed by pharmacies that are 

19 not an affiliate of the pharmacy 

20 benefit manager and that are in21 cluded in the pharmacy network 

22 of such plan. 

23 ‘‘(cc) The interquartile range 

24 of the total combined costs paid 

25 by the plan and plan enrollees, 


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1 per dosage unit, per course of 

2 treatment, per 30-day supply, and 

3 per 90-day supply for each drug 

4 dispensed by pharmacies that are 

5 an affiliate of the pharmacy ben6 efit manager and that are in7 cluded in the pharmacy network 

8 of such plan. 

9 ‘‘(dd) The lowest total com10 bined cost paid by the plan and 

11 plan enrollees, per dosage unit, 

12 per course of treatment, per 30- 

13 day supply, and per 90-day sup14 ply, for each drug that is avail15 able from any pharmacy included 

16 in the pharmacy network of such 

17 plan. 

18 ‘‘(ee) The difference between 

19 the average acquisition cost of the 

20 affiliate, such as a pharmacy or 

21 other entity that acquires pre22 scription drugs, that initially ac23 quires the drug and the amount 

24 reported under subclause (I)(jj) 

25 for each drug. 


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1 ‘‘(ff) A list inclusive of the 

2 brand name, generic or non-pro3 prietary name, and National 

4 Drug Code of covered part D 

5 drugs subject to an agreement 

6 with a covered entity under sec7 tion 340B of the Public Health 

8 Service Act for which the phar9 macy benefit manager or an affil10 iate of the pharmacy benefit man11 ager had a contract or other ar12 rangement with such a covered en13 tity in the service area of such 

14 plan. 

15 ‘‘(III) Where a drug approved 

16 under section 505(c) of the Federal 

17 Food, Drug, and Cosmetic Act (referred 

18 to in this subclause as the ‘listed drug’) 

19 is covered by the plan, the following 

20 information: 

21 ‘‘(aa) A list of currently 

22 marketed generic drugs approved 

23 under section 505(j) of the Federal 

24 Food, Drug, and Cosmetic Act 

25 pursuant to an application that 


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1 references such listed drug that 

2 are not covered by the plan, are 

3 covered on the same formulary 

4 tier or a formulary tier typically 

5 associated with higher cost-shar6 ing than the listed drug, or are 

7 subject to utilization management 

8 that the listed drug is not subject 

9 to. 

10 ‘‘(bb) The estimated average 

11 beneficiary cost-sharing under the 

12 plan for a 30-day supply of the 

13 listed drug. 

14 ‘‘(cc) Where a generic drug 

15 listed under item (aa) is on a for16 mulary tier typically associated 

17 with higher cost-sharing than the 

18 listed drug, the estimated average 

19 cost-sharing that a beneficiary 

20 would have paid for a 30-day 

21 supply of each of the generic drugs 

22 described in item (aa), had the 

23 plan provided coverage for such 

24 drugs on the same formulary tier 

25 as the listed drug. 


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1 ‘‘(dd) A written justification 

2 for providing more favorable cov3 erage of the listed drug than the 

4 generic drugs described in item 

5 (aa). 

6 ‘‘(ee) The number of cur7 rently marketed generic drugs ap8 proved under section 505(j) of the 

9 Federal Food, Drug, and Cosmetic 

10 Act pursuant to an application 

11 that references such listed drug. 

12 ‘‘(IV) Where a reference product 

13 (as defined in section 351(i) of the 

14 Public Health Service Act) is covered 

15 by the plan, the following information: 

16 ‘‘(aa) A list of currently 

17 marketed biosimilar biological 

18 products licensed under section 

19 351(k) of the Public Health Serv20 ice Act pursuant to an applica21 tion that refers to such reference 

22 product that are not covered by 

23 the plan, are covered on the same 

24 formulary tier or a formulary tier 

25 typically associated with higher 


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1 cost-sharing than the reference 

2 product, or are subject to utiliza3 tion management that the ref4 erence product is not subject to. 

5 ‘‘(bb) The estimated average 

6 beneficiary cost-sharing under the 

7 plan for a 30-day supply of the 

8 reference product. 

9 ‘‘(cc) Where a biosimilar bio10 logical product listed under item 

11 (aa) is on a formulary tier typi12 cally associated with higher cost13 sharing than the listed drug, the 

14 estimated average cost-sharing 

15 that a beneficiary would have 

16 paid for a 30-day supply of each 

17 of the biosimilar biological prod18 ucts described in item (aa), had 

19 the plan provided coverage for 

20 such products on the same for21 mulary tier as the reference prod22 uct. 

23 ‘‘(dd) A written justification 

24 for providing more favorable cov25 erage of the reference product than 


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1 the biosimilar biological product 

2 described in item (aa). 

3 ‘‘(ee) The number of cur4 rently marketed biosimilar bio5 logical products licensed under 

6 section 351(k) of the Public 

7 Health Service Act, pursuant to 

8 an application that refers to such 

9 reference product. 

10 ‘‘(V) Total gross spending on cov11 ered part D drugs by the plan, not net 

12 of rebates, fees, discounts, or other di13 rect or indirect remuneration. 

14 ‘‘(VI) The total amount retained 

15 by the pharmacy benefit manager or 

16 an affiliate of such pharmacy benefit 

17 manager in revenue related to utiliza18 tion of covered part D drugs under 

19 that plan, inclusive of bona fide service 

20 fees. 

21 ‘‘(VII) The total spending on cov22 ered part D drugs net of rebates, fees, 

23 discounts, or other direct and indirect 

24 remuneration by the plan. 


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1 ‘‘(VIII) An explanation of any 

2 benefit design parameters under such 

3 plan that encourage plan enrollees to 

4 fill prescriptions at pharmacies that 

5 are an affiliate of such pharmacy ben6 efit manager, such as mail and spe7 cialty home delivery programs, and re8 tail and mail auto-refill programs. 

9 ‘‘(IX) The following information: 

10 ‘‘(aa) A list of all brokers, 

11 consultants, advisors, and audi12 tors that receive compensation 

13 from the pharmacy benefit man14 ager or an affiliate of such phar15 macy benefit manager for refer16 rals, consulting, auditing, or other 

17 services offered to PDP sponsors 

18 related to pharmacy benefit man19 agement services. 

20 ‘‘(bb) The amount of com21 pensation provided by such phar22 macy benefit manager or affiliate 

23 to each such broker, consultant, 

24 advisor, and auditor. 


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1 ‘‘(cc) The methodology for 

2 calculating the amount of com3 pensation provided by such phar4 macy benefit manager or affiliate, 

5 for each such broker, consultant, 

6 advisor, and auditor. 

7 ‘‘(X) A list of all affiliates of the 

8 pharmacy benefit manager. 

9 ‘‘(XI) A summary document sub10 mitted in a standardized template de11 veloped by the Secretary that includes 

12 such information described in sub13 clauses (I) through (X). 

14 ‘‘(ii) WRITTEN EXPLANATION OF CON15 TRACTS OR AGREEMENTS WITH DRUG MANU16 FACTURERS.— 

17 ‘‘(I) IN GENERAL.—The pharmacy 

18 benefit manager shall, not later than 

19 30 days after the finalization of any 

20 contract or agreement between such 

21 pharmacy benefit manager or an affil22 iate of such pharmacy benefit manager 

23 and a drug manufacturer (or sub24 sidiary, agent, or entity affiliated with 

25 such drug manufacturer) that makes 


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1 rebates, discounts, payments, or other 

2 financial incentives related to one or 

3 more covered part D drugs or other 

4 prescription drugs, as applicable, of 

5 the manufacturer directly or indirectly 

6 contingent upon coverage, formulary 

7 placement, or utilization management 

8 conditions on any other covered part D 

9 drugs or other prescription drugs, as 

10 applicable, submit to the PDP sponsor 

11 a written explanation of such contract 

12 or agreement. 

13 ‘‘(II) REQUIREMENTS.—A written 

14 explanation under subclause (I) 

15 shall— 

16 ‘‘(aa) include the manufac17 turer subject to the contract or 

18 agreement, all covered part D 

19 drugs and other prescription 

20 drugs, as applicable, subject to the 

21 contract or agreement and the 

22 manufacturers of such drugs, and 

23 a high-level description of the 

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1 ment and how such terms apply 

2 to such drugs; and 

3 ‘‘(bb) be certified by the Chief 

4 Executive Officer, Chief Financial 

5 Officer, or General Counsel of 

6 such pharmacy benefit manager, 

7 or affiliate of such pharmacy ben8 efit manager, as applicable, or an 

9 individual delegated with the au10 thority to sign on behalf of one of 

11 these officers, who reports directly 

12 to the officer. 

13 ‘‘(III) DEFINITION OF OTHER

14 PRESCRIPTION DRUGS.—For purposes 

15 of this clause, the term ‘other prescrip16 tion drugs’ means prescription drugs 

17 covered as supplemental benefits under 

18 this part or prescription drugs paid 

19 outside of this part. 

20 ‘‘(D) AUDIT RIGHTS.— 

21 ‘‘(i) IN GENERAL.—Not less than once 

22 a year, at the request of the PDP sponsor, 

23 the pharmacy benefit manager shall allow 

24 for an audit of the pharmacy benefit man25 ager to ensure compliance with all terms 


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1 and conditions under the written agreement 

2 and the accuracy of information reported 

3 under subparagraph (C). 

4 ‘‘(ii) AUDITOR.—The PDP sponsor 

5 shall have the right to select an auditor. The 

6 pharmacy benefit manager shall not impose 

7 any limitations on the selection of such 

8 auditor. 

9 ‘‘(iii) PROVISION OF INFORMATION.— 

10 The pharmacy benefit manager shall make 

11 available to such auditor all records, data, 

12 contracts, and other information necessary 

13 to confirm the accuracy of information pro14 vided under subparagraph (C), subject to 

15 reasonable restrictions on how such infor16 mation must be reported to prevent redisclo17 sure of such information. 

18 ‘‘(iv) TIMING.—The pharmacy benefit 

19 manager must provide information under 

20 clause (iii) and other information, data, 

21 and records relevant to the audit to such 

22 auditor within 6 months of the initiation of 

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1 in 30 days after the request for additional 

2 information. 

3 ‘‘(v) INFORMATION FROM AFFILI4 ATES.—The pharmacy benefit manager 

5 shall be responsible for providing to such 

6 auditor information required to be reported 

7 under subparagraph (C) that is owned or 

8 held by an affiliate of such pharmacy ben9 efit manager. 

10 ‘‘(2) ENFORCEMENT.— 

11 ‘‘(A) IN GENERAL.—Each PDP sponsor 

12 shall— 

13 ‘‘(i) disgorge to the Secretary any 

14 amounts disgorged to the PDP sponsor by a 

15 pharmacy benefit manager under para16 graph (1)(A)(v); 

17 ‘‘(ii) require, in a written agreement 

18 with any pharmacy benefit manager acting 

19 on behalf of such sponsor or affiliate of such 

20 pharmacy benefit manager, that such phar21 macy benefit manager or affiliate reimburse 

22 the PDP sponsor for any civil money pen23 alty imposed on the PDP sponsor as a re24 sult of the failure of the pharmacy benefit 

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1 ments of paragraph (1) that are applicable 

2 to the pharmacy benefit manager or affil3 iate under the agreement; and 

4 ‘‘(iii) require, in a written agreement 

5 with any such pharmacy benefit manager 

6 acting on behalf of such sponsor or affiliate 

7 of such pharmacy benefit manager, that 

8 such pharmacy benefit manager or affiliate 

9 be subject to punitive remedies for breach of 

10 contract for failure to comply with the re11 quirements applicable under paragraph (1). 

12 ‘‘(B) REPORTING OF ALLEGED VIOLA13 TIONS.—The Secretary shall make available and 

14 maintain a mechanism for manufacturers, PDP 

15 sponsors, pharmacies, and other entities that 

16 have contractual relationships with pharmacy 

17 benefit managers or affiliates of such pharmacy 

18 benefit managers to report, on a confidential 

19 basis, alleged violations of paragraph (1)(A) or 

20 subparagraph (C). 

21 ‘‘(C) ANTI-RETALIATION AND ANTI-COER22 CION.—Consistent with applicable Federal or 

23 State law, a PDP sponsor shall not— 


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1 ‘‘(i) retaliate against an individual or 

2 entity for reporting an alleged violation 

3 under subparagraph (B); or 

4 ‘‘(ii) coerce, intimidate, threaten, or 

5 interfere with the ability of an individual 

6 or entity to report any such alleged viola7 tions. 

8 ‘‘(3) CERTIFICATION OF COMPLIANCE.— 

9 ‘‘(A) IN GENERAL.—Each PDP sponsor 

10 shall furnish to the Secretary (in a time and 

11 manner specified by the Secretary) an annual 

12 certification of compliance with this subsection, 

13 as well as such information as the Secretary de14 termines necessary to carry out this subsection. 

15 ‘‘(B) IMPLEMENTATION.—Notwithstanding 

16 any other provision of law, the Secretary may 

17 implement this paragraph by program instruc18 tion or otherwise. 

19 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 

20 subsection shall be construed as prohibiting payments 

21 related to reimbursement for ingredient costs to any 

22 entity that acquires prescription drugs, such as a 

23 pharmacy or wholesaler. 

24 ‘‘(5) STANDARD FORMATS.— 


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1 ‘‘(A) IN GENERAL.—Not later than June 1, 

2 2026, the Secretary shall specify standard, ma3 chine-readable formats for pharmacy benefit 

4 managers to submit annual reports required 

5 under paragraph (1)(C)(i). 

6 ‘‘(B) IMPLEMENTATION.—Notwithstanding 

7 any other provision of law, the Secretary may 

8 implement this paragraph by program instruc9 tion or otherwise. 

10 ‘‘(6) CONFIDENTIALITY.— 

11 ‘‘(A) IN GENERAL.—Information disclosed 

12 by a pharmacy benefit manager, an affiliate of 

13 a pharmacy benefit manager, a PDP sponsor, or 

14 a pharmacy under this subsection that is not 

15 otherwise publicly available or available for pur16 chase shall not be disclosed by the Secretary or 

17 a PDP sponsor receiving the information, except 

18 that the Secretary may disclose the information 

19 for the following purposes: 

20 ‘‘(i) As the Secretary determines nec21 essary to carry out this part. 

22 ‘‘(ii) To permit the Comptroller Gen23 eral to review the information provided. 


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1 ‘‘(iii) To permit the Director of the 

2 Congressional Budget Office to review the 

3 information provided. 

4 ‘‘(iv) To permit the Executive Director 

5 of the Medicare Payment Advisory Commis6 sion to review the information provided. 

7 ‘‘(v) To the Attorney General for the 

8 purposes of conducting oversight and en9 forcement under this title. 

10 ‘‘(vi) To the Inspector General of the 

11 Department of Health and Human Services 

12 in accordance with its authorities under the 

13 Inspector General Act of 1978 (section 406 

14 of title 5, United States Code), and other 

15 applicable statutes. 

16 ‘‘(B) RESTRICTION ON USE OF INFORMA17 TION.—The Secretary, the Comptroller General, 

18 the Director of the Congressional Budget Office, 

19 and the Executive Director of the Medicare Pay20 ment Advisory Commission shall not report on 

21 or disclose information disclosed pursuant to 

22 subparagraph (A) to the public in a manner that 

23 would identify— 


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1 ‘‘(i) a specific pharmacy benefit man2 ager, affiliate, pharmacy, manufacturer, 

3 wholesaler, PDP sponsor, or plan; or 

4 ‘‘(ii) contract prices, rebates, discounts, 

5 or other remuneration for specific drugs in 

6 a manner that may allow the identification 

7 of specific contracting parties or of such 

8 specific drugs. 

9 ‘‘(7) DEFINITIONS.—For purposes of this sub10 section: 

11 ‘‘(A) AFFILIATE.—The term ‘affiliate’ 

12 means any entity that is owned by, controlled 

13 by, or related under a common ownership struc14 ture with a pharmacy benefit manager or PDP 

15 sponsor, or that acts as a contractor or agent to 

16 such pharmacy benefit manager or PDP sponsor, 

17 insofar as such contractor or agent performs any 

18 of the functions described under subparagraph 

19 (C). 

20 ‘‘(B) BONA FIDE SERVICE FEE.—The term 

21 ‘bona fide service fee’ means a fee that is reflec22 tive of the fair market value (as specified by the 

23 Secretary) for a bona fide, itemized service actu24 ally performed on behalf of an entity, that the 

25 entity would otherwise perform (or contract for) 


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1 in the absence of the service arrangement and 

2 that is not passed on in whole or in part to a 

3 client or customer, whether or not the entity 

4 takes title to the drug. Such fee must be a flat 

5 dollar amount and shall not be directly or indi6 rectly based on, or contingent upon— 

7 ‘‘(i) drug price, such as wholesale ac8 quisition cost or drug benchmark price 

9 (such as average wholesale price); 

10 ‘‘(ii) the amount of discounts, rebates, 

11 fees, or other direct or indirect remunera12 tion with respect to covered part D drugs 

13 dispensed to enrollees in a prescription drug 

14 plan, except as permitted pursuant to para15 graph (1)(A)(ii); 

16 ‘‘(iii) coverage or formulary placement 

17 decisions or the volume or value of any re18 ferrals or business generated between the 

19 parties to the arrangement; or 

20 ‘‘(iv) any other amounts or methodolo21 gies prohibited by the Secretary. 

22 ‘‘(C) PHARMACY BENEFIT MANAGER.—The 

23 term ‘pharmacy benefit manager’ means any 

24 person or entity that, either directly or through 

25 an intermediary, acts as a price negotiator or 


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1 group purchaser on behalf of a PDP sponsor or 

2 prescription drug plan, or manages the prescrip3 tion drug benefits provided by such sponsor or 

4 plan, including the processing and payment of 

5 claims for prescription drugs, the performance of 

6 drug utilization review, the processing of drug 

7 prior authorization requests, the adjudication of 

8 appeals or grievances related to the prescription 

9 drug benefit, contracting with network phar10 macies, controlling the cost of covered part D 

11 drugs, or the provision of related services. Such 

12 term includes any person or entity that carries 

13 out one or more of the activities described in the 

14 preceding sentence, irrespective of whether such 

15 person or entity calls itself a ‘pharmacy benefit 

16 manager’.’’. 

17 (2) MA–PD PLANS.—Section 1857(f)(3) of the 

18 Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 

19 amended by adding at the end the following new sub20 paragraph: 

21 ‘‘(F) REQUIREMENTS RELATING TO PHAR22 MACY BENEFIT MANAGERS.—For plan years be23 ginning on or after January 1, 2027, section 

24 1860D–12(h).’’. 


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1 (3) NONAPPLICATION OF PAPERWORK REDUCTION

2 ACT.—Chapter 35 of title 44, United States Code, 

3 shall not apply to the implementation of this sub4 section. 

5 (4) FUNDING.— 

6 (A) SECRETARY.—In addition to amounts 

7 otherwise available, there is appropriated to the 

8 Centers for Medicare & Medicaid Services Pro9 gram Management Account, out of any money in 

10 the Treasury not otherwise appropriated, 

11 $113,000,000 for fiscal year 2025, to remain 

12 available until expended, to carry out this sub13 section. 

14 (B) OIG.—In addition to amounts other15 wise available, there is appropriated to the In16 spector General of the Department of Health and 

17 Human Services, out of any money in the Treas18 ury not otherwise appropriated, $20,000,000 for 

19 fiscal year 2025, to remain available until ex20 pended, to carry out this subsection. 

21 (b) GAO STUDY AND REPORT ON CERTAIN REPORTING

22 REQUIREMENTS.— 

23 (1) STUDY.—The Comptroller General of the 

24 United States (in this subsection referred to as the 

25 ‘‘Comptroller General’’) shall conduct a study on FedVerDate Sep 11 2014 20:14 Dec 27, 2024 Jkt 059200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6203 E:\BILLS\H8261.RH H8261

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1 eral and State reporting requirements for health 

2 plans and pharmacy benefit managers related to the 

3 transparency of prescription drug costs and prices. 

4 Such study shall include an analysis of the following: 

5 (A) Federal statutory and regulatory re6 porting requirements for health plans and phar7 macy benefit managers related to prescription 

8 drug costs and prices. 

9 (B) Selected States’ statutory and regu10 latory reporting requirements for health plans 

11 and pharmacy benefit managers related to pre12 scription drug costs and prices. 

13 (C) The extent to which the statutory and 

14 regulatory reporting requirements identified in 

15 subparagraphs (A) and (B) overlap and conflict. 

16 (D) The resources required by health plans 

17 and pharmacy benefit managers to comply with 

18 the reporting requirements described in subpara19 graphs (A) and (B). 

20 (E) Other items determined appropriate by 

21 the Comptroller General. 

22 (2) REPORT.—Not later than 2 years after the 

23 date on which information is first required to be re24 ported under section 1860D–12(h)(1)(C) of the Social 

25 Security Act, as added by subsection (a)(1), the 


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1 Comptroller General shall submit to Congress a report 

2 containing the results of the study conducted under 

3 paragraph (1), together with recommendations for leg4 islation and administrative actions that would 

5 streamline and reduce the burden associated with the 

6 reporting requirements for health plans and phar7 macy benefit managers described in paragraph (1). 

8 (c) MEDPAC REPORTS ON AGREEMENTS WITH PHAR9 MACY BENEFIT MANAGERS WITH RESPECT TO PRESCRIP10 TION DRUG PLANS AND MA–PD PLANS.—The Medicare 

11 Payment Advisory Commission shall submit to Congress the 

12 following reports: 

13 (1) Not later than March 31, 2028, a report re14 garding agreements with pharmacy benefit managers 

15 with respect to prescription drug plans and MA–PD 

16 plans. Such report shall include— 

17 (A) a description of trends and patterns, in18 cluding relevant averages, totals, and other fig19 ures for each of the types of information sub20 mitted; 

21 (B) an analysis of any differences in agree22 ments and their effects on plan enrollee out-of23 pocket spending and average pharmacy reim24 bursement, and any other impacts; and 


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1 (C) any recommendations the Commission 

2 determines appropriate. 

3 (2) Not later than March 31, 2030, a report de4 scribing any changes with respect to the information 

5 described in paragraph (1) over time, together with 

6 any recommendations the Commission determines ap7 propriate. 

8 SEC. 303. EXTENDING THE ADJUSTMENT TO THE CALCULA9 TION OF HOSPICE CAP AMOUNTS UNDER THE 

10 MEDICARE PROGRAM. 

11 Section 1814(i)(2)(B) of the Social Security Act (42 

12 U.S.C. 1395f(i)(2)(B)) is amended— 

13 (1) in clause (ii), by striking ‘‘2033’’ and insert14 ing ‘‘2034’’; and 

15 (2) in clause (iii), by striking ‘‘2033’’ and in16 serting ‘‘2034’’. 


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Union Calendar No. 786 

118TH CONGRESS 

2D SESSION H. R. 8261 

[Report No. 118–891, Part I] 

A BILL 

To amend title XVIII of the Social Security Act to 

other purposes. ments under the Medicare program, and for extend certain flexibilities and payment adjustDECEMBER 19, 2024 

Committee on Energy and Commerce discharged; comState of the Union and ordered to be printed mitted to the Committee of the Whole House on the 


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