Medicaid VBPs for Patients Act

IB Union Calendar No. 768 118TH CONGRESS 2D SESSION H. R. 2666 [Report No. 118–743, Part I] To amend title XIX of the Social Security Act to codify value-based pur- chasing arrangements under the Medicaid program and reforms related to price reporting under such arrangements, and for other purposes. IN THE HOUSE OF REPRESENTATIVES APRIL 18, 2023 Mr. GUTHRIE (for himself, Ms. ESHOO, Mr. JOYCE of Pennsylvania, Mr. AUCHINCLOSS, Mrs. MILLER-MEEKS, and Mr. PETERS) introduced the following bill; which was referred to the Committee on Energy and Com- merce, and in addition to the Committee on Ways and Means, for a pe- riod to be subsequently determined by the Speaker, in each case for con- sideration of such provisions as fall within the jurisdiction of the com- mittee concerned NOVEMBER 18, 2024 Reported from the Committee on Energy and Commerce with an amendment [Strike out all after the enacting clause and insert the part printed in italic] NOVEMBER 18, 2024 Referral to the Committee on Ways and Means extended for a period ending not later than December 19, 2024 DECEMBER 19, 2024 Additional sponsors: Mr. SWALWELL, Mr. CRENSHAW, Mr. BILIRAKIS, Mr. DUNN of Florida, Mr. BALDERSON, Mr. PHILLIPS, Mr. BERA, Mr. LIEU, Mr. THOMPSON of California, Ms. SHERRILL, Ms. HOULAHAN, Mr. CAR- TER of Georgia, Mr. GOTTHEIMER, Mr. CARTER of Louisiana, Mr. FER- GUSON, Mr. HUFFMAN, Mr. MULLIN, Ms. PETTERSEN, Mr. BURGESS, Mr. IVEY, Mr. KELLY of Pennsylvania, Mr. AUSTIN SCOTT of Georgia, Mr. OWENS, Mr. MOOLENAAR, Mr. MEUSER, Mr. CISCOMANI, Ms. CARAVEO, Mr. VAN DREW, Mr. DUNCAN, Ms. MALLIOTAKIS, Mrs. STEEL, Mrs. CAMMACK, Ms. VAN DUYNE and Ms. STRICKLAND VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 2 •HR 2666 RH DECEMBER 19, 2024 Committee on Ways and Means 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 April 18, 2023] A BILL To amend title XIX of the Social Security Act to codify value-based purchasing arrangements under the Medicaid program and reforms related to price reporting under such arrangements, and for other purposes. VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6652 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 3 •HR 2666 RH Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medicaid VBPs for Pa- 4 tients Act’’ or the ‘‘MVP Act’’. 5 SEC. 2. CODIFYING VALUE-BASED PURCHASING ARRANGE- 6 MENTS UNDER MEDICAID AND REFORMS RE- 7 LATED TO PRICE REPORTING UNDER SUCH 8 ARRANGEMENTS. 9 (a) CODIFYING MULTIPLE BEST PRICE POINTS.— 10 (1) IN GENERAL.—Section 1927(c)(1)(C)(ii) of 11 the Social Security Act (42 U.S.C. 1396r– 12 8(c)(1)(C)(ii)) is amended— 13 (A) in subclause (IV), by striking ‘‘and’’ at 14 the end; 15 (B) in subclause (V), by striking the period 16 and inserting ‘‘; and’’; and 17 (C) by adding at the end the following new 18 subclause: 19 ‘‘(VI) may include multiple best 20 price points for a single dosage form 21 and strength of a drug of a manufac- 22 turer subject to a value-based pur- 23 chasing arrangement (as defined in 24 subsection (k)(12)), but only if such 25 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 4 •HR 2666 RH manufacturer offers such arrangement 1 to all States.’’. 2 (2) RULE OF CONSTRUCTION.—Nothing in the 3 amendments made by this subsection may be con- 4 strued to prohibit a manufacturer from treating a 5 value-based purchasing arrangement as a bundled 6 sale. 7 (b) DEFINITION OF AVERAGE MANUFACTURER 8 PRICE.— 9 (1) IN GENERAL.—Section 1927(k)(1) of the So- 10 cial Security Act (42 U.S.C. 1396r-8(k)(1)) is amend- 11 ed— 12 (A) in subparagraph (B)(i)— 13 (i) in subclause (VII), by striking at 14 the end ‘‘and’’; 15 (ii) in subclause (VIII), by striking the 16 period at the end and inserting ‘‘; and’’; 17 and 18 (iii) by adding at the end the following 19 new subclause: 20 ‘‘(IX) with respect to such covered 21 outpatient drug that is sold under a 22 value-based purchasing arrangement 23 (as defined in paragraph (12)) during 24 the rebate period, including such drug 25 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 5 •HR 2666 RH that is an inhalation, infusion, in- 1 stilled, implanted, or injectable drug 2 that is not generally dispensed through 3 a retail community pharmacy— 4 ‘‘(aa) a refund, rebate, reim- 5 bursement, or free goods from the 6 manufacturer or third party on 7 behalf of the manufacturer; or 8 ‘‘(bb) the withholding or re- 9 duction of a payment to the man- 10 ufacturer or third party on behalf 11 of the manufacturer; 12 that is triggered by a patient who fails 13 to achieve outcomes or measures de- 14 fined under the terms of such value- 15 based purchasing arrangement during 16 the period for which such arrangement 17 is effective.’’; and 18 (B) by adding at the end the following new 19 subparagraph: 20 ‘‘(D) SPECIAL RULE FOR CERTAIN VALUE- 21 BASED PURCHASING ARRANGEMENTS.—For pur- 22 poses of subparagraph (A), in determining the 23 average price paid to the manufacturer for a 24 covered outpatient drug that is sold under a 25 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 6 •HR 2666 RH value-based purchasing arrangement (as defined 1 in paragraph (12)) that provides that payment 2 for such drug is made in installments over the 3 course of such agreement, such price shall be de- 4 termined as if the aggregate price per the terms 5 of the agreement was paid in full in the first in- 6 stallment during the rebate period.’’. 7 (2) RULEMAKING.—Not later than 180 days 8 after the date of the enactment of this Act, the Sec- 9 retary of Health and Human Services shall imple- 10 ment the amendments made by this subsection 11 through rulemaking. 12 (c) DEFINITION OF VALUE-BASED PURCHASING AR- 13 RANGEMENT.—Section 1927(k) of the Social Security Act 14 (42 U.S.C. 1396r-8(k)) shall be amended by adding at the 15 end the following paragraph: 16 ‘‘(12) VALUE-BASED PURCHASING ARRANGE- 17 MENT.—The term ‘value-based purchasing arrange- 18 ment’ has the meaning given such term in section 19 447.502 of title 42, Code of Federal Regulations (or 20 any successor regulation).’’. 21 SEC. 3. CALCULATION OF AVERAGE SALES PRICE UNDER 22 MEDICARE. 23 Section 1847A(c)(3) of the Social Security Act (42 24 U.S.C. 1395w–3a(c)(3)) is amended— 25 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 7 •HR 2666 RH (1) by striking ‘‘In calculating’’ and inserting 1 the following: 2 ‘‘(A) IN GENERAL.—Subject to subpara- 3 graph (B), in calculating’’; and 4 (2) by adding at the end the following new sub- 5 paragraph: 6 ‘‘(B) CERTAIN REMUNERATION UNDER 7 VALUE-BASED PURCHASING ARRANGEMENTS EX- 8 CLUDED.—In calculating the manufacturer’s av- 9 erage sales price under this subsection for a drug 10 or biological that is sold under a value-based 11 purchasing arrangement (as defined in section 12 1927(k)(12)) and with respect to which the man- 13 ufacturer of such drug or biological has elected to 14 include multiple best price points (as described 15 in section 1927(c)(1)(C)(ii)(VI)) in reporting the 16 best price of such drug under section 1927(b), 17 such price shall not include any amount that is 18 excluded from the calculation of the average 19 manufacturer price of such drug or biological 20 under section 1927(k)(1)(B)(i)(IX).’’. 21 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 8 •HR 2666 RH SEC. 4. GUIDANCE ON VALUE-BASED PURCHASING AR- 1 RANGEMENTS FOR INPATIENT DRUGS UNDER 2 MEDICAID. 3 Not later than 180 days after the date of the enactment 4 of this Act, the Secretary of Health and Human Services 5 shall issue guidance to State Medicaid agencies on the op- 6 tion of entering into a value-based purchasing arrangement 7 (as defined in section 1927(k)(12) of the Social Security 8 Act (42 U.S.C. 1396r–8(k)(12))) with manufacturers for 9 drugs or biological products provided as part of, or as inci- 10 dent to and in the same setting as, inpatient hospital serv- 11 ices furnished under a State plan under title XIX of the 12 Social Security Act (42 U.S.C. 1396 et seq.), or under a 13 waiver of such plan, where such drugs or biological products 14 are reimbursed directly and not paid for as part of pay- 15 ment for such inpatient hospital services, including guid- 16 ance on how multiple States may enter into agreements 17 with one another and with manufacturers which permit the 18 transfer of funds between the participating States so that 19 individuals who reside in a State different from the State 20 in which they receive a drug subject to a value-based pur- 21 chasing arrangement as an inpatient may be treated as if 22 they received such drug in the State in which they reside. 23 SEC. 5. EXCEPTION UNDER THE ANTIKICKBACK STATUTE. 24 (a) IN GENERAL.—Section 1128B(b)(3) of the Social 25 Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended— 26 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 9 •HR 2666 RH (1) in subparagraph (J), by moving the left mar- 1 gin of such subparagraph 2 ems to the left; 2 (2) in subparagraph (K)— 3 (A) by moving the left margin of such sub- 4 paragraph 2 ems to the left; and 5 (B) by striking ‘‘and’’ at the end; 6 (3) in subparagraph (L)(iii), by striking the pe- 7 riod and inserting ‘‘; and’’; and 8 (4) by adding at the end the following new sub- 9 paragraph: 10 ‘‘(M) any remuneration provided by a man- 11 ufacturer or third party on behalf of a manufac- 12 turer to a State under a value-based purchasing 13 arrangement (as defined in section 1927(k)(12)) 14 under a State plan under title XIX (or waiver 15 of such plan) in the case a patient fails to 16 achieve outcomes or measures defined in such ar- 17 rangement following the administration of a cov- 18 ered outpatient drug (as defined in section 19 1927(k)(2)).’’. 20 (b) RULEMAKING.—Not later than 180 days after the 21 date of the enactment of this Act, the Inspector General of 22 the Department of Health and Human Services shall 23 through rulemaking implement the amendments made by 24 this section. 25 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 10 •HR 2666 RH SEC. 6. GAO STUDY AND REPORT ON USE OF VALUE-BASED 1 PURCHASING ARRANGEMENTS. 2 (a) STUDY.—The Comptroller General of the United 3 States shall conduct a study on the extent to which value- 4 based purchasing arrangements (as defined in section 5 1927(k)(12) of the Social Security Act (42 U.S.C. 1396r- 6 8(k)(12)) facilitate patient access to covered outpatient 7 drugs, improve patient outcomes, lower overall health sys- 8 tem costs, and lower costs for patients in Federal health 9 care programs. In conducting such study, the Comptroller 10 General shall— 11 (1) study the impact of this Act on— 12 (A) access to transformative therapies, in- 13 cluding rare disease gene therapies, generally; 14 (B) mitigating socioeconomic disparities in 15 accessing covered outpatient drugs sold under 16 value-based purchasing arrangements through its 17 requirement that State Medicaid programs have 18 access to the same value-based purchasing ar- 19 rangement pricing structure that are available 20 in the commercial market for such drugs; 21 (C) the Medicaid drug rebate program 22 under section 1927 of the Social Security Act (42 23 U.S.C. 1396r–8), the 340B drug pricing pro- 24 gram under section 340B of the Public Health 25 Service Act (42 U.S.C. 256b), and part B of title 26 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS 11 •HR 2666 RH XVIII of the Social Security Act (42 U.S.C. 1 1395j et seq.), including compliance with such 2 programs; 3 (D) expenditures under State Medicaid pro- 4 grams; and 5 (E) prices for such drugs under the Med- 6 icaid program in States that do not enter into 7 such arrangements; 8 (2) analyze all the types of value-based pur- 9 chasing arrangement pricing structures, which struc- 10 tures are working well (as measured by price and ease 11 of implementing), and which need improvement; and 12 (3) study the potential long-term savings for 13 States that enter into such arrangements under State 14 Medicaid programs. 15 (b) REPORT.—Not later than June 30, 2028, the 16 Comptroller General of the United States shall submit to 17 Congress a report containing the results of the study con- 18 ducted under subsection (a). 19 VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS Union Calendar No. 768 118TH CONGRESS 2D SESSION H. R. 2666 [Report No. 118–743, Part I] A BILL To amend title XIX of the Social Security Act to codify value-based purchasing arrangements under the Medicaid program and reforms related to price reporting under such arrangements, and for other purposes. DECEMBER 19, 2024 Committee on Ways and Means discharged; committed to the Committee of the Whole House on the State of the Union and ordered to be printed VerDate Sep 11 2014 01:33 Dec 24, 2024 Jkt 059200 PO 00000 Frm 00012 Fmt 6651 Sfmt 6651 E:\BILLS\H2666.RH H2666 ssavage on LAPJG3WLY3PROD with BILLS