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 committee 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. 

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’’. 


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1 TITLE I—PRESERVING PA2 TIENTS’ ACCESS TO CARE IN 

3 THE HOME 

4 SEC. 101. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILI5 TIES. 

6 (a) REMOVING GEOGRAPHIC REQUIREMENTS AND

7 EXPANDING ORIGINATING SITES FOR TELEHEALTH

8 SERVICES.—Section 1834(m) of the Social Security Act 

9 (42 U.S.C. 1395m) is amended— 

10 (1) in paragraph (2)(B)(iii), by striking ‘‘end11 ing December 31, 2024’’ and inserting ‘‘ending De12 cember 31, 2026’’; and 

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

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

15 December 31, 2026’’. 

16 (b) EXPANDING PRACTITIONERS ELIGIBLE TO FUR17 NISH TELEHEALTH SERVICES.—Section 1834(m)(4)(E) 

18 of the Social Security Act (42 U.S.C. 1395m(m)(4)(E)) 

19 is amended by striking ‘‘ending on December 31, 2024’’ 

20 and inserting ‘‘ending on December 31, 2026’’. 

21 (c) EXTENDING TELEHEALTH SERVICES FOR FED22 ERALLY QUALIFIED HEALTH CENTERS AND RURAL

23 HEALTH CLINICS.—Section 1834(m)(8)(A) of the Social 

24 Security Act (42 U.S.C. 1395m(m)(8)(A)) is amended by 


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1 striking ‘‘ending on December 31, 2024’’ and inserting 

2 ‘‘ending on December 31, 2026’’. 

3 (d) DELAYING THE IN-PERSON REQUIREMENTS

4 UNDER MEDICARE FOR MENTAL HEALTH SERVICES

5 FURNISHED THROUGH TELEHEALTH AND TELE6 COMMUNICATIONS TECHNOLOGY.— 

7 (1) DELAY IN REQUIREMENTS FOR MENTAL

8 HEALTH SERVICES FURNISHED THROUGH TELE9 HEALTH.—Section 1834(m)(7)(B)(i) of the Social 

10 Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is 

11 amended, in the matter preceding subclause (I), by 

12 striking ‘‘on or after’’ and all that follows through 

13 ‘‘described in section 1135(g)(1)(B))’’ and inserting 

14 ‘‘on or after January 1, 2027’’. 

15 (2) MENTAL HEALTH VISITS FURNISHED BY

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

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

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

19 follows through the period at the end and inserting 

20 ‘‘January 1, 2027.’’. 

21 (3) MENTAL HEALTH VISITS FURNISHED BY

22 FEDERALLY QUALIFIED HEALTH CENTERS.—Section 

23 1834(o)(4)(B) of the Social Security Act (42 U.S.C. 

24 1395m(o)(4)(B)) is amended by striking ‘‘January 


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1 1, 2025’’ and all that follows through the period at 

2 the end and inserting ‘‘January 1, 2027.’’. 

3 (e) ALLOWING FOR THE FURNISHING OF AUDIO4 ONLY TELEHEALTH SERVICES.—Section 1834(m)(9) of 

5 the Social Security Act (42 U.S.C. 1395m(m)(9)) is 

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

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

8 (f) EXTENDING USE OF TELEHEALTH TO CONDUCT

9 FACE-TO-FACE ENCOUNTER PRIOR TO RECERTIFICATION

10 OF ELIGIBILITY FOR HOSPICE CARE.—Section 

11 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 

12 1395f(a)(7)(D)(i)(II)) is amended— 

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

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

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

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

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

18 if such individual is located in an area that is sub19 ject to a moratorium on the enrollment of hospice 

20 programs under this title pursuant to section 

21 1866(j)(7), if such individual is receiving hospice 

22 care from a provider that is subject to enhanced 

23 oversight under this title pursuant to section 

24 1866(j)(3), or if such encounter is performed by a 

25 hospice physician or nurse practitioner who is not 


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1 enrolled under section 1866(j) and is not an opt-out 

2 physician or practitioner (as defined in section 

3 1802(b)(6)(D))’’ before the semicolon. 

4 (g) PROGRAM INSTRUCTION AUTHORITY.—The Sec5 retary of Health and Human Services may implement the 

6 amendments made by this section through program in7 struction or otherwise. 

8 SEC. 102. GUIDANCE ON FURNISHING SERVICES VIA TELE9 HEALTH TO INDIVIDUALS WITH LIMITED 

10 ENGLISH PROFICIENCY. 

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

12 date of the enactment of this section, the Secretary of 

13 Health and Human Services, in consultation with 1 or 

14 more entities from each of the categories described in 

15 paragraphs (1) through (7) of subsection (b), shall issue 

16 and disseminate, or update and revise as applicable, guid17 ance for the entities described in such subsection on the 

18 following: 

19 (1) Best practices on facilitating and inte20 grating use of interpreters during a telemedicine ap21 pointment. 

22 (2) Best practices on providing accessible in23 structions on how to access telecommunications sys24 tems (as such term is used for purposes of section 

25 1834(m) of the Social Security Act (42 U.S.C. 


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1 1395m(m)) for individuals with limited English pro2 ficiency. 

3 (3) Best practices on improving access to dig4 ital patient portals for individuals with limited 

5 English proficiency. 

6 (4) Best practices on integrating the use of 

7 video platforms that enable multi-person video calls 

8 furnished via a telecommunications system for pur9 poses of providing interpretation during a telemedi10 cine appointment for an individual with limited 

11 English proficiency. 

12 (5) Best practices for providing patient mate13 rials, communications, and instructions in multiple 

14 languages, including text message appointment re15 minders and prescription information. 

16 (b) ENTITIES DESCRIBED.—For purposes of sub17 section (a), an entity described in this subsection is an 

18 entity in 1 or more of the following categories: 

19 (1) Health information technology service pro20 viders, including— 

21 (A) electronic medical record companies; 

22 (B) remote patient monitoring companies; 

23 and 

24 (C) telehealth or mobile health vendors and 

25 companies. 


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1 (2) Health care providers, including— 

2 (A) physicians; and 

3 (B) hospitals. 

4 (3) Health insurers. 

5 (4) Language service companies. 

6 (5) Interpreter or translator professional asso7 ciations. 

8 (6) Health and language services quality certifi9 cation organizations. 

10 (7) Patient and consumer advocates, including 

11 such advocates that work with individuals with lim12 ited English proficiency. 

13 SEC. 103. ESTABLISHMENT OF MODIFIER FOR RECERTIFI14 CATIONS OF HOSPICE CARE ELIGIBILITY 

15 CONDUCTED THROUGH TELEHEALTH. 

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

17 Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)), as amended by sec18 tion 101(f), is further amended by inserting ‘‘, provided 

19 that, in the case of such an encounter occurring on or 

20 after the date that is 2 years after the date of the enact21 ment of the ‘Preserving Telehealth, Hospital, and Ambu22 lance Access Act’, such physician or nurse practitioner in23 cludes in any claim for such encounter one or more modi24 fiers or codes specified by the Secretary to indicate that 


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1 such encounter was furnished through telehealth’’ after 

2 ‘‘as determined appropriate by the Secretary’’. 

3 SEC. 104. EXTENDING ACUTE HOSPITAL CARE AT HOME 

4 WAIVER FLEXIBILITIES. 

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

6 1395cc–7) is amended— 

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

8 inserting ‘‘2029’’; and 

9 (2) in subsection (b)— 

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

11 REPORT’’ and inserting ‘‘STUDIES AND RE12 PORTS’’; 

13 (B) in paragraph (1)— 

14 (i) in the matter preceding subpara15 graph (A), by striking ‘‘The Secretary’’ 

16 and inserting ‘‘Not later than September 

17 30, 2024, and again not later than Sep18 tember 30, 2028, the Secretary’’; 

19 (ii) in clause (vi), by striking ‘‘and’’ at 

20 the end; 

21 (iii) in clause (vii), by striking the pe22 riod and inserting ‘‘; and’’; and 

23 (iv) by adding at the end the following 

24 new clause: 


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1 ‘‘(viii) in the case of the second study 

2 conducted under this paragraph, the qual3 ity of care, outcomes, costs, quantity and 

4 intensity of services, and other relevant 

5 metrics between individuals who entered 

6 into the Acute Hospital Care at Home ini7 tiative directly from an emergency depart8 ment compared with individuals who en9 tered into the Acute Hospital Care at 

10 Home initiative directly from an existing 

11 inpatient stay in a hospital.’’; and 

12 (C) in paragraph (2)— 

13 (i) in the header, by striking ‘‘RE14 PORT’’ and inserting ‘‘REPORTS’’; and 

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

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

17 and 

18 (iii) by striking ‘‘on the study con19 ducted under paragraph (1).’’ and insert20 ing the following: ‘‘on— 

21 ‘‘(A) with respect to the first report sub22 mitted under this paragraph, the first study 

23 conducted 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 sub8 mit to Congress a report on, the capabilities and limita9 tions of wearable medical devices used to support clinical 

10 decision-making. Such report shall include a description 

11 of— 

12 (1) the potential for such devices to accurately 

13 prescribe treatments; 

14 (2) an examination of the benefits and chal15 lenges of artificial intelligence to augment such ca16 pabilities; and 

17 (3) policy options to enhance the benefits and 

18 mitigate potential challenges of developing or using 

19 such devices. 

20 SEC. 106. ENHANCING CERTAIN PROGRAM INTEGRITY RE21 QUIREMENTS FOR DME UNDER MEDICARE. 

22 (a) DURABLE MEDICAL EQUIPMENT.—Section 

23 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) 

24 is amended by adding at the end the following new para25 graph: 


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

3 ‘‘(A) MASTER LIST INCLUSION.—Begin4 ning January 1, 2026, for purposes of the Mas5 ter List described in section 414.234(b) of title 

6 42, Code of Federal Regulations (or any suc7 cessor regulation), an item for which payment 

8 may be made under this subsection shall be 

9 treated as having aberrant billing patterns (as 

10 such term is used for purposes of such section) 

11 if the Secretary determines that, without ex12 planatory contributing factors (such as fur13 nishing emergent care services), a substantial 

14 number of written orders for such items under 

15 this subsection are from an ordering physician 

16 or applicable practitioner with whom the indi17 vidual involved does not have a prior relation18 ship, as determined on the basis of prior pay19 ment experience. 

20 ‘‘(B) CLAIM REVIEW.—With respect to 

21 items furnished on or after January 1, 2026 

22 that are included on the Master List pursuant 

23 to subparagraph (A), if such an item is not sub24 ject to a determination of coverage in advance 

25 pursuant to paragraph (15)(C), the Secretary 


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1 may conduct prepayment review of claims for 

2 payment for such item.’’. 

3 (b) REPORT ON IDENTIFYING CLINICAL DIAGNOSTIC

4 LABORATORY TESTS AT HIGH RISK FOR FRAUD AND EF5 FECTIVE MITIGATION MEASURES.—Not later than Janu6 ary 1, 2026, the Inspector General of the Department of 

7 Health and Human Services shall submit to Congress a 

8 report assessing fraudulent claims for clinical diagnostic 

9 laboratory tests for which payment may be made under 

10 section 1834A of the Social Security Act (42 U.S.C. 

11 1395m–1) and effective tools for reducing such fraudulent 

12 claims. The report shall include— 

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

14 tests are identified as being at high risk of fraudu15 lent claims, and an analysis of the factors that con16 tribute to such risk; 

17 (2) with respect to a clinical diagnostic labora18 tory test identified under subparagraph (A) as being 

19 at high risk of fraudulent claims— 

20 (A) the amount payable under such section 

21 1834A with respect to such test; 

22 (B) the number of such tests furnished to 

23 individuals enrolled under part B of title XVIII 

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

25 seq.); 


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

2 more likely to come from a provider with whom 

3 the individual involved did not have a prior re4 lationship, as determined on the basis of prior 

5 payment experience; and 

6 (D) the frequency with which a claim for 

7 payment under such section 1834A included the 

8 payment modifier identified by code 59 or 91; 

9 and 

10 (3) suggested strategies for reducing the num11 ber of fraudulent claims made with respect to tests 

12 so identified as being at high risk, including— 

13 (A) an analysis of whether the Centers for 

14 Medicare & Medicaid Services can detect aber15 rant billing patterns with respect to such tests 

16 in a timely manner; 

17 (B) any strategies for identifying and mon18 itoring the providers who are outliers with re19 spect to the number of such tests that such pro20 viders order; and 

21 (C) targeted education efforts to mitigate 

22 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 

10 the portion of fiscal year 2025 beginning on January 

11 1, 2025, and ending on September 30, 2025, and’’; 

12 (2) in subparagraph (C)(i)— 

13 (A) in the matter preceding subclause 

14 (I)— 

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

16 year’’; and 

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

18 of fiscal year 2025 beginning on October 1, 

19 2024, and ending on December 31, 2024’’ 

20 and inserting ‘‘2025’’; 

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

22 and the portion of fiscal year 2025 beginning 

23 on October 1, 2024, and ending on December 

24 31, 2024’’ and inserting ‘‘2025’’; and 


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1 (C) in subclause (IV), by striking ‘‘the por2 tion of fiscal year 2025 beginning on January 

3 1, 2025, and ending on September 30, 2025, 

4 and’’; and 

5 (3) in subparagraph (D)— 

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

7 striking ‘‘2024 or during the portion of fiscal 

8 year 2025 beginning on October 1, 2024, and 

9 ending on December 31, 2024’’ and inserting 

10 ‘‘2025’’; and 

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

12 the portion of fiscal year 2025 beginning on Oc13 tober 1, 2024, and ending on December 31, 

14 2024’’ and inserting ‘‘2025’’. 

15 (b) IMPLEMENTATION.—Notwithstanding any other 

16 provision of law, the Secretary of Health and Human 

17 Services may implement the provisions of, including the 

18 amendments made by, this section by program instruction 

19 or otherwise. 

20 SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOS21 PITAL PROGRAM. 

22 (a) IN GENERAL.—Section 1886(d)(5)(G) of the So23 cial Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amend24 ed— 


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

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

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

4 2025’’ and inserting ‘‘October 1, 2025’’. 

5 (b) CONFORMING AMENDMENTS.— 

6 (1) EXTENSION OF TARGET AMOUNT.—Section 

7 1886(b)(3)(D) of the Social Security Act (42 U.S.C. 

8 1395ww(b)(3)(D)) is amended— 

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

10 striking ‘‘January 1, 2025’’ and inserting ‘‘Oc11 tober 1, 2025’’; and 

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

13 the portion of fiscal year 2025 beginning on Oc14 tober 1, 2024, and ending on December 31, 

15 2024’’ and inserting ‘‘2025’’. 

16 (2) PERMITTING HOSPITALS TO DECLINE RE17 CLASSIFICATION.—Section 13501(e)(2) of the Omni18 bus Budget Reconciliation Act of 1993 (42 U.S.C. 

19 1395ww note) is amended by striking ‘‘2024, or the 

20 portion of fiscal year 2025 beginning on October 1, 

21 2024, and ending on December 31, 2024’’ and in22 serting ‘‘2025’’. 


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1 SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBU2 LANCE SERVICES. 

3 (a) IN GENERAL.—Section 1834(l) of the Social Se4 curity Act (42 U.S.C. 1395m(l)) is amended— 

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

6 1, 2025’’ and inserting ‘‘October 1, 2025’’; and 

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

8 2025’’ in each place it appears and inserting ‘‘Octo9 ber 1, 2025’’ in each such place. 

10 (b) PROGRAM INSTRUCTION AUTHORITY.—Notwith11 standing any other provision of law, the Secretary of 

12 Health and Human Services may implement the provisions 

13 of, including amendments made by, this section through 

14 program instruction or otherwise. 

15 TITLE III—OFFSETS 

16 SEC. 301. REVISING PHASE-IN OF MEDICARE CLINICAL LAB17 ORATORY TEST PAYMENT CHANGES. 

18 (a) REVISED PHASE-IN OF REDUCTIONS FROM PRI19 VATE PAYOR RATE IMPLEMENTATION.—Section 

20 1834A(b)(3) of the Social Security Act (42 U.S.C. 

21 1395m–1(b)(3)) is amended— 

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

23 and inserting ‘‘2028’’; and 

24 (2) in subparagraph (B)— 

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

26 inserting ‘‘2025’’; and 


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

2 through 2027’’ and inserting ‘‘2026 through 

3 2028’’. 

4 (b) REVISED REPORTING PERIOD FOR REPORTING

5 OF PRIVATE SECTOR PAYMENT RATES FOR ESTABLISH6 MENT OF MEDICARE PAYMENT RATES.—Section 

7 1834A(a)(1)(B) of the Social Security Act (42 U.S.C. 

8 1395m–1(a)(1)(B)) is amended— 

9 (1) in clause (i), by striking ‘‘2024’’ and insert10 ing ‘‘2025’’; and 

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

12 it appears and inserting ‘‘2026’’. 

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

14 Human Services may implement the amendments made by 

15 this section by program instruction or otherwise. 

16 SEC. 302. ARRANGEMENTS WITH PHARMACY BENEFIT MAN17 AGERS WITH RESPECT TO PRESCRIPTION 

18 DRUG PLANS AND MA–PD PLANS. 

19 (a) IN GENERAL.— 

20 (1) PRESCRIPTION DRUG PLANS.—Section 

21 1860D–12 of the Social Security Act (42 U.S.C. 

22 1395w–112) is amended by adding at the end the 

23 following new subsection: 


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1 ‘‘(h) REQUIREMENTS RELATING TO PHARMACY BEN2 EFIT MANAGERS.—For plan years beginning on or after 

3 January 1, 2027: 

4 ‘‘(1) AGREEMENTS WITH PHARMACY BENEFIT

5 MANAGERS.—Each contract entered into with a 

6 PDP sponsor under this part with respect to a pre7 scription drug plan offered by such sponsor shall 

8 provide that any pharmacy benefit manager acting 

9 on behalf of such sponsor has a written agreement 

10 with the PDP sponsor under which the pharmacy 

11 benefit manager, and any affiliates of such phar12 macy benefit manager, as applicable, agree to meet 

13 the following requirements: 

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

15 SERVICE FEES.— 

16 ‘‘(i) IN GENERAL.—The pharmacy 

17 benefit manager and any affiliate of such 

18 pharmacy benefit manager shall not derive 

19 any remuneration with respect to any serv20 ices provided on behalf of any entity or in21 dividual, in connection with the utilization 

22 of covered part D drugs, from any such en23 tity or individual other than bona fide serv24 ice fees, subject to clauses (ii) and (iii). 


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1 ‘‘(ii) INCENTIVE PAYMENTS.—For the 

2 purposes of this subsection, an incentive 

3 payment paid by a PDP sponsor to a phar4 macy benefit manager that is performing 

5 services on behalf of such sponsor shall be 

6 deemed a ‘bona fide service fee’(even if 

7 such payment does not otherwise meet the 

8 definition of such term under paragraph 

9 (7)(B)) if such payment is a flat dollar 

10 amount, is consistent with fair market 

11 value (as specified by the Secretary), is re12 lated to services actually performed by the 

13 pharmacy benefit manager or affiliate of 

14 such pharmacy benefit manager, on behalf 

15 of the entity making such payment, in con16 nection with the utilization of covered part 

17 D drugs, and meets additional require18 ments, if any, as determined appropriate 

19 by the Secretary. 

20 ‘‘(iii) CLARIFICATION ON REBATES

21 AND DISCOUNTS USED TO LOWER COSTS

22 FOR COVERED PART D DRUGS.—Rebates, 

23 discounts, and other price concessions re24 ceived by a pharmacy benefit manager or 

25 an affiliate of a pharmacy benefit manager 


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1 from manufacturers, even if such price 

2 concessions are calculated as a percentage 

3 of a drug’s price, shall not be considered a 

4 violation of the requirements of clause (i) 

5 if they are fully passed through to a PDP 

6 sponsor and are compliant with all regu7 latory and subregulatory requirements re8 lated to direct and indirect remuneration 

9 for manufacturer rebates under this part, 

10 including in cases where a PDP sponsor is 

11 acting as a pharmacy benefit manager on 

12 behalf of a prescription drug plan offered 

13 by such PDP sponsor. 

14 ‘‘(iv) EVALUATION OF REMUNERATION

15 ARRANGEMENTS.—Components of subsets 

16 of remuneration arrangements (such as 

17 fees or other forms of compensation paid 

18 to or retained by the pharmacy benefit 

19 manager or affiliate of such pharmacy ben20 efit manager), as determined appropriate 

21 by the Secretary, between pharmacy ben22 efit managers or affiliates of such phar23 macy benefit managers, as applicable, and 

24 other entities involved in the dispensing or 

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1 ing PDP sponsors, manufacturers, phar2 macies, and other entities as determined 

3 appropriate by the Secretary) shall be sub4 ject to review by the Secretary, in con5 sultation with the Office of the Inspector 

6 General of the Department of Health and 

7 Human Services, as determined appro8 priate by the Secretary. The Secretary, in 

9 consultation with the Office of the Inspec10 tor General, shall review whether remu11 neration under such arrangements is con12 sistent with fair market value (as specified 

13 by the Secretary) through reviews and as14 sessments of such remuneration, as deter15 mined appropriate. 

16 ‘‘(v) DISGORGEMENT.—The pharmacy 

17 benefit manager shall disgorge any remu18 neration paid to such pharmacy benefit 

19 manager or an affiliate of such pharmacy 

20 benefit manager in violation of this sub21 paragraph to the PDP sponsor. 

22 ‘‘(vi) ADDITIONAL REQUIREMENTS.— 

23 The pharmacy benefit manager shall— 

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1 macy benefit manager, under which 

2 the affiliate shall identify and disgorge 

3 any remuneration described in clause 

4 (v) to the pharmacy benefit manager; 

5 and 

6 ‘‘(II) attest, subject to any re7 quirements determined appropriate by 

8 the Secretary, that the pharmacy ben9 efit manager has entered into a writ10 ten agreement described in subclause 

11 (I) with any relevant affiliate of the 

12 pharmacy benefit manager. 

13 ‘‘(B) TRANSPARENCY REGARDING GUARAN14 TEES AND COST PERFORMANCE EVALUA15 TIONS.—The pharmacy benefit manager shall— 

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

17 fully transparent and consistent manner 

18 for purposes of calculating or otherwise 

19 evaluating pharmacy benefit manager per20 formance against pricing guarantees or 

21 similar cost performance measurements re22 lated to rebates, discounts, price conces23 sions, or net costs, terms such as— 

24 ‘‘(I) ‘generic drug’, in a manner 

25 consistent with the definition of the 


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1 term under section 423.4 of title 42, 

2 Code of Federal Regulations, or a suc3 cessor regulation; 

4 ‘‘(II) ‘brand name drug’, in a 

5 manner consistent with the definition 

6 of the term under section 423.4 of 

7 title 42, Code of Federal Regulations, 

8 or a successor regulation; 

9 ‘‘(III) ‘specialty drug’; 

10 ‘‘(IV) ‘rebate’; and 

11 ‘‘(V) ‘discount’; 

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

13 price concessions excluded from any pric14 ing guarantee or other cost performance 

15 calculation or evaluation in a clear and 

16 consistent manner; and 

17 ‘‘(iii) where a pricing guarantee or 

18 other cost performance measure is based 

19 on a pricing benchmark other than the 

20 wholesale acquisition cost (as defined in 

21 section 1847A(c)(6)(B)) of a drug, cal22 culate and provide a wholesale acquisition 

23 cost-based equivalent to the pricing guar24 antee or other cost performance measure 

25 in the written agreement. 


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1 ‘‘(C) PROVISION OF INFORMATION.— 

2 ‘‘(i) IN GENERAL.—Not later than 

3 July 1 of each year, beginning in 2027, the 

4 pharmacy benefit manager shall submit to 

5 the PDP sponsor, and to the Secretary, a 

6 report, in accordance with this subpara7 graph, and shall make such report avail8 able to such sponsor at no cost to such 

9 sponsor in a format specified by the Sec10 retary under paragraph (5). Each such re11 port shall include, with respect to such 

12 PDP sponsor and each plan offered by 

13 such sponsor, the following information 

14 with respect to the previous plan year: 

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

16 the plan that were dispensed includ17 ing, with respect to each such drug— 

18 ‘‘(aa) the brand name, ge19 neric or non-proprietary name, 

20 and National Drug Code; 

21 ‘‘(bb) the number of plan 

22 enrollees for whom the drug was 

23 dispensed, the total number of 

24 prescription claims for the drug 

25 (including original prescriptions 


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1 and refills, counted as separate 

2 claims), and the total number of 

3 dosage units of the drug dis4 pensed; 

5 ‘‘(cc) the number of pre6 scription claims described in item 

7 (bb) by each type of dispensing 

8 channel through which the drug 

9 was dispensed, including retail, 

10 mail order, specialty pharmacy, 

11 long term care pharmacy, home 

12 infusion pharmacy, or other types 

13 of pharmacies or providers; 

14 ‘‘(dd) the average wholesale 

15 acquisition cost, listed as cost per 

16 day’s supply, cost per dosage 

17 unit, and cost per typical course 

18 of treatment (as applicable); 

19 ‘‘(ee) the average wholesale 

20 price for the drug, listed as cost 

21 per day’s supply, cost per dosage 

22 unit, and cost per typical course 

23 of treatment (as applicable); 

24 ‘‘(ff) the total out-of-pocket 

25 spending by plan enrollees on 


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1 such drug after application of 

2 any benefits under the plan, in3 cluding plan enrollee spending 

4 through copayments, coinsurance, 

5 and deductibles; 

6 ‘‘(gg) total rebates paid by 

7 the manufacturer on the drug as 

8 reported under the Detailed DIR 

9 Report (or any successor report) 

10 submitted by such sponsor to the 

11 Centers for Medicare & Medicaid 

12 Services; 

13 ‘‘(hh) all other direct or in14 direct remuneration on the drug 

15 as reported under the Detailed 

16 DIR Report (or any successor re17 port) submitted by such sponsor 

18 to the Centers for Medicare & 

19 Medicaid Services; 

20 ‘‘(ii) the average pharmacy 

21 reimbursement amount paid by 

22 the plan for the drug in the ag23 gregate and disaggregated by dis24 pensing channel identified in item 

25 (cc); 


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1 ‘‘(jj) the average National 

2 Average Drug Acquisition Cost 

3 (NADAC); and 

4 ‘‘(kk) total manufacturer-de5 rived revenue, inclusive of bona 

6 fide service fees, attributable to 

7 the drug and retained by the 

8 pharmacy benefit manager and 

9 any affiliate of such pharmacy 

10 benefit manager. 

11 ‘‘(II) In the case of a pharmacy 

12 benefit manager that has an affiliate 

13 that is a retail, mail order, or spe14 cialty pharmacy, with respect to drugs 

15 covered by such plan that were dis16 pensed, the following information: 

17 ‘‘(aa) The percentage of 

18 total prescriptions that were dis19 pensed by pharmacies that are an 

20 affiliate of the pharmacy benefit 

21 manager for each drug. 

22 ‘‘(bb) The interquartile 

23 range of the total combined costs 

24 paid by the plan and plan enroll25 ees, per dosage unit, per course 


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1 of treatment, per 30-day supply, 

2 and per 90-day supply for each 

3 drug dispensed by pharmacies 

4 that are not an affiliate of the 

5 pharmacy benefit manager and 

6 that are included in the phar7 macy network of such plan. 

8 ‘‘(cc) The interquartile 

9 range of the total combined costs 

10 paid by the plan and plan enroll11 ees, per dosage unit, per course 

12 of treatment, per 30-day supply, 

13 and per 90-day supply for each 

14 drug dispensed by pharmacies 

15 that are an affiliate of the phar16 macy benefit manager and that 

17 are included in the pharmacy 

18 network of such plan. 

19 ‘‘(dd) The lowest total com20 bined cost paid by the plan and 

21 plan enrollees, per dosage unit, 

22 per course of treatment, per 30- 

23 day supply, and per 90-day sup24 ply, for each drug that is avail25 able from any pharmacy included 


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1 in the pharmacy network of such 

2 plan. 

3 ‘‘(ee) The difference between 

4 the average acquisition cost of 

5 the affiliate, such as a pharmacy 

6 or other entity that acquires pre7 scription drugs, that initially ac8 quires the drug and the amount 

9 reported under subclause (I)(jj) 

10 for each drug. 

11 ‘‘(ff) A list inclusive of the 

12 brand name, generic or non-pro13 prietary name, and National 

14 Drug Code of covered part D 

15 drugs subject to an agreement 

16 with a covered entity under sec17 tion 340B of the Public Health 

18 Service Act for which the phar19 macy benefit manager or an affil20 iate of the pharmacy benefit 

21 manager had a contract or other 

22 arrangement with such a covered 

23 entity in the service area of such 

24 plan. 


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1 ‘‘(III) Where a drug approved 

2 under section 505(c) of the Federal 

3 Food, Drug, and Cosmetic Act (re4 ferred to in this subclause as the ‘list5 ed drug’) is covered by the plan, the 

6 following information: 

7 ‘‘(aa) A list of currently 

8 marketed generic drugs approved 

9 under section 505(j) of the Fed10 eral Food, Drug, and Cosmetic 

11 Act pursuant to an application 

12 that references such listed drug 

13 that are not covered by the plan, 

14 are covered on the same for15 mulary tier or a formulary tier 

16 typically associated with higher 

17 cost-sharing than the listed drug, 

18 or are subject to utilization man19 agement that the listed drug is 

20 not subject to. 

21 ‘‘(bb) The estimated average 

22 beneficiary cost-sharing under 

23 the plan for a 30-day supply of 

24 the listed drug. 


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1 ‘‘(cc) Where a generic drug 

2 listed under item (aa) is on a for3 mulary tier typically associated 

4 with higher cost-sharing than the 

5 listed drug, the estimated aver6 age cost-sharing that a bene7 ficiary would have paid for a 30- 

8 day supply of each of the generic 

9 drugs described in item (aa), had 

10 the plan provided coverage for 

11 such drugs on the same for12 mulary tier as the listed drug. 

13 ‘‘(dd) A written justification 

14 for providing more favorable cov15 erage of the listed drug than the 

16 generic drugs described in item 

17 (aa). 

18 ‘‘(ee) The number of cur19 rently marketed generic drugs 

20 approved under section 505(j) of 

21 the Federal Food, Drug, and 

22 Cosmetic Act pursuant to an ap23 plication that references such 

24 listed drug. 


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1 ‘‘(IV) Where a reference product 

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

3 Public Health Service Act) is covered 

4 by the plan, the following information: 

5 ‘‘(aa) A list of currently 

6 marketed biosimilar biological 

7 products licensed under section 

8 351(k) of the Public Health 

9 Service Act pursuant to an appli10 cation that refers to such ref11 erence product that are not cov12 ered by the plan, are covered on 

13 the same formulary tier or a for14 mulary tier typically associated 

15 with higher cost-sharing than the 

16 reference product, or are subject 

17 to utilization management that 

18 the reference product is not sub19 ject to. 

20 ‘‘(bb) The estimated average 

21 beneficiary cost-sharing under 

22 the plan for a 30-day supply of 

23 the reference product. 

24 ‘‘(cc) Where a biosimilar bi25 ological product listed under item 


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1 (aa) is on a formulary tier typi2 cally associated with higher cost3 sharing than the listed drug, the 

4 estimated average cost-sharing 

5 that a beneficiary would have 

6 paid for a 30-day supply of each 

7 of the biosimilar biological prod8 ucts described in item (aa), had 

9 the plan provided coverage for 

10 such products on the same for11 mulary tier as the reference prod12 uct. 

13 ‘‘(dd) A written justification 

14 for providing more favorable cov15 erage of the reference product 

16 than the biosimilar biological 

17 product described in item (aa). 

18 ‘‘(ee) The number of cur19 rently marketed biosimilar bio20 logical products licensed under 

21 section 351(k) of the Public 

22 Health Service Act, pursuant to 

23 an application that refers to such 

24 reference product. 


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1 ‘‘(V) Total gross spending on 

2 covered part D drugs by the plan, not 

3 net of rebates, fees, discounts, or 

4 other direct or indirect remuneration. 

5 ‘‘(VI) The total amount retained 

6 by the pharmacy benefit manager or 

7 an affiliate of such pharmacy benefit 

8 manager in revenue related to utiliza9 tion of covered part D drugs under 

10 that plan, inclusive of bona fide serv11 ice fees. 

12 ‘‘(VII) The total spending on cov13 ered part D drugs net of rebates, fees, 

14 discounts, or other direct and indirect 

15 remuneration by the plan. 

16 ‘‘(VIII) An explanation of any 

17 benefit design parameters under such 

18 plan that encourage plan enrollees to 

19 fill prescriptions at pharmacies that 

20 are an affiliate of such pharmacy ben21 efit manager, such as mail and spe22 cialty home delivery programs, and re23 tail and mail auto-refill programs. 

24 ‘‘(IX) The following information: 


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1 ‘‘(aa) A list of all brokers, 

2 consultants, advisors, and audi3 tors that receive compensation 

4 from the pharmacy benefit man5 ager or an affiliate of such phar6 macy benefit manager for refer7 rals, consulting, auditing, or 

8 other services offered to PDP 

9 sponsors related to pharmacy 

10 benefit management services. 

11 ‘‘(bb) The amount of com12 pensation provided by such phar13 macy benefit manager or affiliate 

14 to each such broker, consultant, 

15 advisor, and auditor. 

16 ‘‘(cc) The methodology for 

17 calculating the amount of com18 pensation provided by such phar19 macy benefit manager or affil20 iate, for each such broker, con21 sultant, advisor, and auditor. 

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

23 pharmacy benefit manager. 

24 ‘‘(XI) A summary document sub25 mitted in a standardized template deVerDate Sep 11 2014 00:06 May 08, 2024 Jkt 049200 PO 00000 Frm 00036 Fmt 6652 Sfmt 6201 E:\BILLS\H8261.IH H8261

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1 veloped by the Secretary that includes 

2 such information described in sub3 clauses (I) through (X). 

4 ‘‘(ii) WRITTEN EXPLANATION OF CON5 TRACTS OR AGREEMENTS WITH DRUG

6 MANUFACTURERS.— 

7 ‘‘(I) IN GENERAL.—The phar8 macy benefit manager shall, not later 

9 than 30 days after the finalization of 

10 any contract or agreement between 

11 such pharmacy benefit manager or an 

12 affiliate of such pharmacy benefit 

13 manager and a drug manufacturer (or 

14 subsidiary, agent, or entity affiliated 

15 with such drug manufacturer) that 

16 makes rebates, discounts, payments, 

17 or other financial incentives related to 

18 one or more covered part D drugs or 

19 other prescription drugs, as applica20 ble, of the manufacturer directly or 

21 indirectly contingent upon coverage, 

22 formulary placement, or utilization 

23 management conditions on any other 

24 covered part D drugs or other pre25 scription drugs, as applicable, submit 


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1 to the PDP sponsor a written expla2 nation of such contract or agreement. 

3 ‘‘(II) REQUIREMENTS.—A writ4 ten explanation under subclause (I) 

5 shall— 

6 ‘‘(aa) include the manufac7 turer subject to the contract or 

8 agreement, all covered part D 

9 drugs and other prescription 

10 drugs, as applicable, subject to 

11 the contract or agreement and 

12 the manufacturers of such drugs, 

13 and a high-level description of 

14 the terms of such contract or 

15 agreement and how such terms 

16 apply to such drugs; and 

17 ‘‘(bb) be certified by the 

18 Chief Executive Officer, Chief Fi19 nancial Officer, or General Coun20 sel of such pharmacy benefit 

21 manager, or affiliate of such 

22 pharmacy benefit manager, as 

23 applicable, or an individual dele24 gated with the authority to sign 

25 on behalf of one of these officers, 


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1 who reports directly to the offi2 cer. 

3 ‘‘(III) DEFINITION OF OTHER

4 PRESCRIPTION DRUGS.—For purposes 

5 of this clause, the term ‘other pre6 scription drugs’ means prescription 

7 drugs covered as supplemental bene8 fits under this part or prescription 

9 drugs paid outside of this part. 

10 ‘‘(D) AUDIT RIGHTS.— 

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

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

13 the pharmacy benefit manager shall allow 

14 for an audit of the pharmacy benefit man15 ager to ensure compliance with all terms 

16 and conditions under the written agree17 ment and the accuracy of information re18 ported under subparagraph (C). 

19 ‘‘(ii) AUDITOR.—The PDP sponsor 

20 shall have the right to select an auditor. 

21 The pharmacy benefit manager shall not 

22 impose any limitations on the selection of 

23 such auditor. 

24 ‘‘(iii) PROVISION OF INFORMATION.— 

25 The pharmacy benefit manager shall make 


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1 available to such auditor all records, data, 

2 contracts, and other information necessary 

3 to confirm the accuracy of information 

4 provided under subparagraph (C), subject 

5 to reasonable restrictions on how such in6 formation must be reported to prevent re7 disclosure of such information. 

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

9 manager must provide information under 

10 clause (iii) and other information, data, 

11 and records relevant to the audit to such 

12 auditor within 6 months of the initiation of 

13 the audit and respond to requests for addi14 tional information from such auditor with15 in 30 days after the request for additional 

16 information. 

17 ‘‘(v) INFORMATION FROM AFFILI18 ATES.—The pharmacy benefit manager 

19 shall be responsible for providing to such 

20 auditor information required to be reported 

21 under subparagraph (C) that is owned or 

22 held by an affiliate of such pharmacy ben23 efit manager. 

24 ‘‘(2) ENFORCEMENT.— 


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1 ‘‘(A) IN GENERAL.—Each PDP sponsor 

2 shall— 

3 ‘‘(i) disgorge to the Secretary any 

4 amounts disgorged to the PDP sponsor by 

5 a pharmacy benefit manager under para6 graph (1)(A)(v); 

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

8 with any pharmacy benefit manager acting 

9 on behalf of such sponsor or affiliate of 

10 such pharmacy benefit manager, that such 

11 pharmacy benefit manager or affiliate re12 imburse the PDP sponsor for any civil 

13 money penalty imposed on the PDP spon14 sor as a result of the failure of the phar15 macy benefit manager or affiliate to meet 

16 the requirements of paragraph (1) that are 

17 applicable to the pharmacy benefit man18 ager or affiliate under the agreement; and 

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

20 with any such pharmacy benefit manager 

21 acting on behalf of such sponsor or affil22 iate of such pharmacy benefit manager, 

23 that such pharmacy benefit manager or af24 filiate be subject to punitive remedies for 

25 breach of contract for failure to comply 


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1 with the requirements applicable under 

2 paragraph (1). 

3 ‘‘(B) REPORTING OF ALLEGED VIOLA4 TIONS.—The Secretary shall make available and 

5 maintain a mechanism for manufacturers, PDP 

6 sponsors, pharmacies, and other entities that 

7 have contractual relationships with pharmacy 

8 benefit managers or affiliates of such pharmacy 

9 benefit managers to report, on a confidential 

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

11 subparagraph (C). 

12 ‘‘(C) ANTI-RETALIATION AND ANTI-COER13 CION.—Consistent with applicable Federal or 

14 State law, a PDP sponsor shall not— 

15 ‘‘(i) retaliate against an individual or 

16 entity for reporting an alleged violation 

17 under subparagraph (B); or 

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

19 interfere with the ability of an individual 

20 or entity to report any such alleged viola21 tions. 

22 ‘‘(3) CERTIFICATION OF COMPLIANCE.— 

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

24 shall furnish to the Secretary (in a time and 

25 manner specified by the Secretary) an annual 


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1 certification of compliance with this subsection, 

2 as well as such information as the Secretary de3 termines necessary to carry out this subsection. 

4 ‘‘(B) IMPLEMENTATION.—Notwithstanding 

5 any other provision of law, the Secretary may 

6 implement this paragraph by program instruc7 tion or otherwise. 

8 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

9 this subsection shall be construed as prohibiting pay10 ments related to reimbursement for ingredient costs 

11 to any entity that acquires prescription drugs, such 

12 as a pharmacy or wholesaler. 

13 ‘‘(5) STANDARD FORMATS.— 

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

15 1, 2026, the Secretary shall specify standard, 

16 machine-readable formats for pharmacy benefit 

17 managers to submit annual reports required 

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

19 ‘‘(B) IMPLEMENTATION.—Notwithstanding 

20 any other provision of law, the Secretary may 

21 implement this paragraph by program instruc22 tion or otherwise. 

23 ‘‘(6) CONFIDENTIALITY.— 

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

25 by a pharmacy benefit manager, an affiliate of 


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1 a pharmacy benefit manager, a PDP sponsor, 

2 or a pharmacy under this subsection that is not 

3 otherwise publicly available or available for pur4 chase shall not be disclosed by the Secretary or 

5 a PDP sponsor receiving the information, ex6 cept that the Secretary may disclose the infor7 mation for the following purposes: 

8 ‘‘(i) As the Secretary determines nec9 essary to carry out this part. 

10 ‘‘(ii) To permit the Comptroller Gen11 eral to review the information provided. 

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

13 Congressional Budget Office to review the 

14 information provided. 

15 ‘‘(iv) To permit the Executive Direc16 tor of the Medicare Payment Advisory 

17 Commission to review the information pro18 vided. 

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

20 purposes of conducting oversight and en21 forcement under this title. 

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

23 Department of Health and Human Serv24 ices in accordance with its authorities 

25 under the Inspector General Act of 1978 


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1 (section 406 of title 5, United States 

2 Code), and other applicable statutes. 

3 ‘‘(B) RESTRICTION ON USE OF INFORMA4 TION.—The Secretary, the Comptroller General, 

5 the Director of the Congressional Budget Of6 fice, and the Executive Director of the Medicare 

7 Payment Advisory Commission shall not report 

8 on or disclose information disclosed pursuant to 

9 subparagraph (A) to the public in a manner 

10 that would identify— 

11 ‘‘(i) a specific pharmacy benefit man12 ager, affiliate, pharmacy, manufacturer, 

13 wholesaler, PDP sponsor, or plan; or 

14 ‘‘(ii) contract prices, rebates, dis15 counts, or other remuneration for specific 

16 drugs in a manner that may allow the 

17 identification of specific contracting parties 

18 or of such specific drugs. 

19 ‘‘(7) DEFINITIONS.—For purposes of this sub20 section: 

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

22 means any entity that is owned by, controlled 

23 by, or related under a common ownership struc24 ture with a pharmacy benefit manager or PDP 

25 sponsor, or that acts as a contractor or agent 


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1 to such pharmacy benefit manager or PDP 

2 sponsor, insofar as such contractor or agent 

3 performs any of the functions described under 

4 subparagraph (C). 

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

6 ‘bona fide service fee’ means a fee that is reflec7 tive of the fair market value (as specified by the 

8 Secretary) for a bona fide, itemized service ac9 tually performed on behalf of an entity, that the 

10 entity would otherwise perform (or contract for) 

11 in the absence of the service arrangement and 

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

13 client or customer, whether or not the entity 

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

15 dollar amount and shall not be directly or indi16 rectly based on, or contingent upon— 

17 ‘‘(i) drug price, such as wholesale ac18 quisition cost or drug benchmark price 

19 (such as average wholesale price); 

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

21 fees, or other direct or indirect remunera22 tion with respect to covered part D drugs 

23 dispensed to enrollees in a prescription 

24 drug plan, except as permitted pursuant to 

25 paragraph (1)(A)(ii); 


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1 ‘‘(iii) coverage or formulary placement 

2 decisions or the volume or value of any re3 ferrals or business generated between the 

4 parties to the arrangement; or 

5 ‘‘(iv) any other amounts or meth6 odologies prohibited by the Secretary. 

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

8 term ‘pharmacy benefit manager’ means any 

9 person or entity that, either directly or through 

10 an intermediary, acts as a price negotiator or 

11 group purchaser on behalf of a PDP sponsor or 

12 prescription drug plan, or manages the pre13 scription drug benefits provided by such spon14 sor or plan, including the processing and pay15 ment of claims for prescription drugs, the per16 formance of drug utilization review, the proc17 essing of drug prior authorization requests, the 

18 adjudication of appeals or grievances related to 

19 the prescription drug benefit, contracting with 

20 network pharmacies, controlling the cost of cov21 ered part D drugs, or the provision of related 

22 services. Such term includes any person or enti23 ty that carries out one or more of the activities 

24 described in the preceding sentence, irrespective 


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1 of whether such person or entity calls itself a 

2 ‘pharmacy benefit manager’.’’. 

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

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

5 amended by adding at the end the following new 

6 subparagraph: 

7 ‘‘(F) REQUIREMENTS RELATING TO PHAR8 MACY BENEFIT MANAGERS.—For plan years be9 ginning on or after January 1, 2027, section 

10 1860D–12(h).’’. 

11 (3) NONAPPLICATION OF PAPERWORK REDUC12 TION ACT.—Chapter 35 of title 44, United States 

13 Code, shall not apply to the implementation of this 

14 subsection. 

15 (4) FUNDING.— 

16 (A) SECRETARY.—In addition to amounts 

17 otherwise available, there is appropriated to the 

18 Centers for Medicare & Medicaid Services Pro19 gram Management Account, out of any money 

20 in the Treasury not otherwise appropriated, 

21 $113,000,000 for fiscal year 2025, to remain 

22 available until expended, to carry out this sub23 section. 

24 (B) OIG.—In addition to amounts other25 wise available, there is appropriated to the InVerDate Sep 11 2014 00:06 May 08, 2024 Jkt 049200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\H8261.IH H8261

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1 spector General of the Department of Health 

2 and Human Services, out of any money in the 

3 Treasury not otherwise appropriated, 

4 $20,000,000 for fiscal year 2025, to remain 

5 available until expended, to carry out this sub6 section. 

7 (b) GAO STUDY AND REPORT ON CERTAIN REPORT8 ING REQUIREMENTS.— 

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

10 United States (in this subsection referred to as the 

11 ‘‘Comptroller General’’) shall conduct a study on 

12 Federal and State reporting requirements for health 

13 plans and pharmacy benefit managers related to the 

14 transparency of prescription drug costs and prices. 

15 Such study shall include an analysis of the following: 

16 (A) Federal statutory and regulatory re17 porting requirements for health plans and phar18 macy benefit managers related to prescription 

19 drug costs and prices. 

20 (B) Selected States’ statutory and regu21 latory reporting requirements for health plans 

22 and pharmacy benefit managers related to pre23 scription drug costs and prices. 

24 (C) The extent to which the statutory and 

25 regulatory reporting requirements identified in 


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1 subparagraphs (A) and (B) overlap and con2 flict. 

3 (D) The resources required by health plans 

4 and pharmacy benefit managers to comply with 

5 the reporting requirements described in sub6 paragraphs (A) and (B). 

7 (E) Other items determined appropriate by 

8 the Comptroller General. 

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

10 date on which information is first required to be re11 ported under section 1860D–12(h)(1)(C) of the So12 cial Security Act, as added by subsection (a)(1), the 

13 Comptroller General shall submit to Congress a re14 port containing the results of the study conducted 

15 under paragraph (1), together with recommenda16 tions for legislation and administrative actions that 

17 would streamline and reduce the burden associated 

18 with the reporting requirements for health plans and 

19 pharmacy benefit managers described in paragraph 

20 (1). 

21 (c) MEDPAC REPORTS ON AGREEMENTS WITH

22 PHARMACY BENEFIT MANAGERS WITH RESPECT TO PRE23 SCRIPTION DRUG PLANS AND MA–PD PLANS.—The 

24 Medicare Payment Advisory Commission shall submit to 

25 Congress the following reports: 


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1 (1) Not later than March 31, 2028, a report re2 garding agreements with pharmacy benefit managers 

3 with respect to prescription drug plans and MA–PD 

4 plans. Such report shall include— 

5 (A) a description of trends and patterns, 

6 including relevant averages, totals, and other 

7 figures for each of the types of information sub8 mitted; 

9 (B) an analysis of any differences in agree10 ments and their effects on plan enrollee out-of11 pocket spending and average pharmacy reim12 bursement, and any other impacts; and 

13 (C) any recommendations the Commission 

14 determines appropriate. 

15 (2) Not later than March 31, 2030, a report de16 scribing any changes with respect to the information 

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

18 any recommendations the Commission determines 

19 appropriate. 

20 SEC. 303. EXTENDING THE ADJUSTMENT TO THE CALCULA21 TION OF HOSPICE CAP AMOUNTS UNDER THE 

22 MEDICARE PROGRAM. 

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

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


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1 (1) in clause (ii), by striking ‘‘2033’’ and in2 serting ‘‘2034’’; and 

3 (2) in clause (iii), by striking ‘‘2033’’ and in4 serting ‘‘2034’’. 

Æ 


ssavage on LAPJG3WLY3PROD with BILLS