HR2666-118

1. Short title This Act may be cited as the Medicaid VBPs for Patients Act or the MVP Act.

2. Codifying value-based purchasing arrangements under Medicaid and reforms related to price reporting under such arrangements Section 1927(c)(1)(C)(ii) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)) is amended— in subclause (IV), by striking and at the end; in subclause (V), by striking the period and inserting ; and; and by adding at the end the following new subclause: may include multiple best price points for a single dosage form and strength of a drug of a manufacturer subject to a value-based purchasing arrangement (as defined in subsection (k)(12)), but only if such manufacturer offers such arrangement to all States. Nothing in the amendments made by this subsection may be construed to prohibit a manufacturer from treating a value-based purchasing arrangement as a bundled sale. Section 1927(k)(1) of the Social Security Act (42 U.S.C. 1396r-8(k)(1)) is amended— in subparagraph (B)(i)— in subclause (VII), by striking at the end and; in subclause (VIII), by striking the period at the end and inserting ; and; and by adding at the end the following new subclause: with respect to such covered outpatient drug that is sold under a value-based purchasing arrangement (as defined in paragraph (12)) during the rebate period, including such drug that is an inhalation, infusion, instilled, implanted, or injectable drug that is not generally dispensed through a retail community pharmacy— a refund, rebate, reimbursement, or free goods from the manufacturer or third party on behalf of the manufacturer; or the withholding or reduction of a payment to the manufacturer or third party on behalf of the manufacturer; by adding at the end the following new subparagraph: For purposes of subparagraph (A), in determining the average price paid to the manufacturer for a covered outpatient drug that is sold under a value-based purchasing arrangement (as defined in paragraph (12)) that provides that payment for such drug is made in installments over the course of such agreement, such price shall be determined as if the aggregate price per the terms of the agreement was paid in full in the first installment during the rebate period. Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall implement the amendments made by this subsection through rulemaking. Section 1927(k) of the Social Security Act (42 U.S.C. 1396r-8(k)) shall be amended by adding at the end the following paragraph: The term value-based purchasing arrangement has the meaning given such term in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation). (VI)may include multiple best price points for a single dosage form and strength of a drug of a manufacturer subject to a value-based purchasing arrangement (as defined in subsection (k)(12)), but only if such manufacturer offers such arrangement to all States.. (IX)with respect to such covered outpatient drug that is sold under a value-based purchasing arrangement (as defined in paragraph (12)) during the rebate period, including such drug that is an inhalation, infusion, instilled, implanted, or injectable drug that is not generally dispensed through a retail community pharmacy—(aa)a refund, rebate, reimbursement, or free goods from the manufacturer or third party on behalf of the manufacturer; or(bb)the withholding or reduction of a payment to the manufacturer or third party on behalf of the manufacturer;that is triggered by a patient who fails to achieve outcomes or measures defined under the terms of such value-based purchasing arrangement during the period for which such arrangement is effective.; and (D)Special rule for certain value-based purchasing arrangementsFor purposes of subparagraph (A), in determining the average price paid to the manufacturer for a covered outpatient drug that is sold under a value-based purchasing arrangement (as defined in paragraph (12)) that provides that payment for such drug is made in installments over the course of such agreement, such price shall be determined as if the aggregate price per the terms of the agreement was paid in full in the first installment during the rebate period.. (12)Value-Based Purchasing ArrangementThe term value-based purchasing arrangement has the meaning given such term in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation)..

3. Calculation of average sales price under Medicare Section 1847A(c)(3) of the Social Security Act (42 U.S.C. 1395w–3a(c)(3)) is amended— by striking In calculating and inserting the following: Subject to subparagraph (B), in calculating by adding at the end the following new subparagraph: In calculating the manufacturer’s average sales price under this subsection for a drug or biological that is sold under a value-based purchasing arrangement (as defined in section 1927(k)(12)) and with respect to which the manufacturer of such drug or biological has elected to include multiple best price points (as described in section 1927(c)(1)(C)(ii)(VI)) in reporting the best price of such drug under section 1927(b), such price shall not include any amount that is excluded from the calculation of the average manufacturer price of such drug or biological under section 1927(k)(1)(B)(i)(IX). (A)In generalSubject to subparagraph (B), in calculating; and (B)Certain remuneration under value-based purchasing arrangements excludedIn calculating the manufacturer’s average sales price under this subsection for a drug or biological that is sold under a value-based purchasing arrangement (as defined in section 1927(k)(12)) and with respect to which the manufacturer of such drug or biological has elected to include multiple best price points (as described in section 1927(c)(1)(C)(ii)(VI)) in reporting the best price of such drug under section 1927(b), such price shall not include any amount that is excluded from the calculation of the average manufacturer price of such drug or biological under section 1927(k)(1)(B)(i)(IX)..

4. Guidance on value-based purchasing arrangements for inpatient drugs under Medicaid Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance to State Medicaid agencies on the option of entering into a value-based purchasing arrangement (as defined in section 1927(k)(12) of the Social Security Act (42 U.S.C. 1396r–8(k)(12))) with manufacturers for drugs or biological products provided as part of, or as incident to and in the same setting as, inpatient hospital services furnished under a State plan under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.), or under a waiver of such plan, where such drugs or biological products are reimbursed directly and not paid for as part of payment for such inpatient hospital services, including guidance on how multiple States may enter into agreements with one another and with manufacturers which permit the transfer of funds between the participating States so that individuals who reside in a State different from the State in which they receive a drug subject to a value-based purchasing arrangement as an inpatient may be treated as if they received such drug in the State in which they reside.

5. Exception under the antikickback statute Section 1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) is amended— in subparagraph (J), by moving the left margin of such subparagraph 2 ems to the left; in subparagraph (K)— by moving the left margin of such subparagraph 2 ems to the left; and by striking and at the end; in subparagraph (L)(iii), by striking the period and inserting ; and; and by adding at the end the following new subparagraph: any remuneration provided by a manufacturer or third party on behalf of a manufacturer to a State under a value-based purchasing arrangement (as defined in section 1927(k)(12)) under a State plan under title XIX (or waiver of such plan) in the case a patient fails to achieve outcomes or measures defined in such arrangement following the administration of a covered outpatient drug (as defined in section 1927(k)(2)). Not later than 180 days after the date of the enactment of this Act, the Inspector General of the Department of Health and Human Services shall through rulemaking implement the amendments made by this section. (M)any remuneration provided by a manufacturer or third party on behalf of a manufacturer to a State under a value-based purchasing arrangement (as defined in section 1927(k)(12)) under a State plan under title XIX (or waiver of such plan) in the case a patient fails to achieve outcomes or measures defined in such arrangement following the administration of a covered outpatient drug (as defined in section 1927(k)(2))..

6. GAO study and report on use of value-based purchasing arrangements The Comptroller General of the United States shall conduct a study on the extent to which value-based purchasing arrangements (as defined in section 1927(k)(12) of the Social Security Act (42 U.S.C. 1396r-8(k)(12)) facilitate patient access to covered outpatient drugs, improve patient outcomes, lower overall health system costs, and lower costs for patients in Federal health care programs. In conducting such study, the Comptroller General shall— study the impact of this Act on— access to transformative therapies, including rare disease gene therapies, generally; mitigating socioeconomic disparities in accessing covered outpatient drugs sold under value-based purchasing arrangements through its requirement that State Medicaid programs have access to the same value-based purchasing arrangement pricing structure that are available in the commercial market for such drugs; the Medicaid drug rebate program under section 1927 of the Social Security Act (42 U.S.C. 1396r–8), the 340B drug pricing program under section 340B of the Public Health Service Act (42 U.S.C. 256b), and part B of title XVIII of the Social Security Act (42 U.S.C. 1395j et seq.), including compliance with such programs; expenditures under State Medicaid programs; and prices for such drugs under the Medicaid program in States that do not enter into such arrangements; analyze all the types of value-based purchasing arrangement pricing structures, which structures are working well (as measured by price and ease of implementing), and which need improvement; and study the potential long-term savings for States that enter into such arrangements under State Medicaid programs. Not later than June 30, 2028, the Comptroller General of the United States shall submit to Congress a report containing the results of the study conducted under subsection (a).