H.R. 7871
MVP Act
Sponsor: Brett Guthrie
Official summary
Written by the Congressional Research Service.
Medicaid VBPs for Patients Act or the MVP Act
This bill provides statutory authority for regulations that allow for the use of varying best price points under value-based purchasing arrangements for purposes of the Medicaid Drug Rebate Program. (Value-based purchasing arrangements refer to arrangements in which the price of a drug is linked to clinical outcomes; such arrangements are particularly used for new high-cost treatments, such as gene therapies.)
The Government Accountability Office must study the impact of value-based purchasing arrangements on federal health care programs, including with respect to the bill's changes.
Additionally, the bill (1) exempts sales of drugs that are made under value-based purchasing arrangements from calculations of the manufacturer average sales price for purposes of payments under Medicare medical services, if the manufacturer reports multiple best prices under Medicaid in accordance with the bill's changes; and (2) requires the Centers for Medicare & Medicaid Services to issue guidance on how state Medicaid programs may cover drugs in inpatient settings via value-based purchasing arrangements.
Text of the bill
(a) Codifying multiple best price points
(1) In general. Section 1927(c)(1)(C)(ii) of the Social Security Act (42 U.S.C. 1396r–8(c)(1)(C)(ii)) is amended—
(A) in subclause (III), by adding a semicolon at the end;
(B) in subclause (IV), by striking and at the end;
(C) in subclause (V), by striking the period and inserting ; and; and
(D) by adding at the end the following new subclause:
(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.
(2) Rule of construction. 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.
(b) Definition of average manufacturer price
(1) In general. Section 1927(k)(1) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)) is amended—
(A) in subparagraph (B)(i)—
(i) in subclause (IV), by adding a semicolon at the end;
(ii) in subclause (VII), by striking at the end and;
(iii) in subclause (VIII), by striking the period at the end and inserting ; and; and
(iv) by adding at the end the following new subclause:
(IX) with respect to a covered outpatient drug that is sold under a value-based purchasing arrangement (as defined in paragraph (12)) during the rebate period, including such a drug that is an inhalation, infusion, instilled, implanted, or injectable drug that is not generally dispensed through a retail community pharmacy— 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.
(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;
; and
(B) by adding at the end the following new subparagraph:
(D) Special rule for certain value-based purchasing arrangements. For purposes of subparagraph (A), in determining the average price paid to a 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 arrangement, such price shall be determined as if the aggregate price per the terms of the arrangement were paid in full in the first installment during the rebate period.
(2) Rulemaking. 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.
(c) Definition of value-Based purchasing arrangement. Section 1927(k) of the Social Security Act (42 U.S.C. 1396r–8(k)) is amended by adding at the end the following paragraph:
(12) Value-Based Purchasing Arrangement. 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).