What does Preamble of S 1637 do?

This bill, formally titled '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,' aims to modify the Social Security Act. The bill intends to codify value-based purchasing arrangements within the Medicaid program. It also proposes reforms related to price reporting under these Medicaid arrangements.

What does SHORT TITLE. of S 1637 do?

This bill is formally titled the Medicaid VBPs for Patients Act.

What does CODIFYING VALUE-BASED PURCHASING ARRANGEMENTS UNDER MEDICAID of S 1637 do?

This section amends Section 1927(c)(1)(C)(ii) of the Social Security Act to allow for multiple best price points for a single drug under a value-based purchasing arrangement, provided the manufacturer offers such an arrangement to all states. It clarifies that a manufacturer may treat a value-based purchasing arrangement as a bundled sale. This section amends Section 1927(k)(1) of the Social Security Act to modify the definition of Average Manufacturer Price, including considerations for refunds, rebates, or withholding of payments triggered by patient outcomes under value-based purchasing arrangements. A special rule is established for value-based purchasing arrangements where payment is made in installments, requiring the price to be determined as if paid in full during the rebate period. The Secretary of Health and Human Services is required to implement these amendments through rulemaking within 180 days of the Act's enactment. This section defines 'value-based purchasing arrangement' as having the meaning given in section 447.502 of title 42, Code of Federal Regulations (or any successor regulation).

What does CALCULATION OF AVERAGE SALES PRICE UNDER MEDICARE. of S 1637 do?

This section amends Section 1847A(c)(3) of the Social Security Act. The amendment introduces a new subparagraph (B) to specify exclusions from the calculation of a manufacturer's average sales price. The exclusion applies to drugs or biologicals sold under value-based purchasing arrangements. Manufacturers who elect to include multiple best price points are eligible for this exclusion. Excluded amounts are those also excluded from the calculation of the average manufacturer price under section 1927(k)(1)(B)(i)(IX).

What does GUIDANCE ON VALUE-BASED PURCHASING ARRANGEMENTS FOR INPATIENT of S 1637 do?

This section requires the Secretary of Health and Human Services to issue guidance to State Medicaid agencies. The guidance concerns the option of entering into value-based purchasing arrangements with manufacturers for drugs or biological products. These arrangements relate to inpatient hospital services furnished under a State plan or waiver. The guidance will address how multiple States may enter into agreements and transfer funds. This applies to drugs or biological products reimbursed directly, not included in payment for inpatient hospital services.

What does EXCEPTION UNDER THE ANTIKICKBACK STATUTE. of S 1637 do?

This section amends Section 1128B(b)(3) of the Social Security Act. Specific changes are made to subparagraphs (J), (K), and (L)(iii) involving adjustments to the left margin and striking of certain words. A new subparagraph (M) is added, exempting certain remuneration from the Anti-Kickback Statute. This new exemption applies to payments from manufacturers or third parties to a State under a value-based purchasing arrangement if a patient fails to achieve defined outcomes after receiving a covered outpatient drug. The Inspector General of the Department of Health and Human Services must implement these amendments through rulemaking within 180 days of the Act's enactment.

What does GAO STUDY AND REPORT ON USE OF VALUE-BASED PURCHASING of S 1637 do?

This section mandates a study by the Comptroller General of the United States regarding value-based purchasing arrangements. The study will examine how these arrangements affect patient access to covered outpatient drugs, patient outcomes, and health system costs. Specific areas of focus include the impact on transformative therapies, socioeconomic disparities in drug access, and compliance with existing drug pricing programs (Medicaid rebates, 340B, and Medicare Part B). The study will analyze different value-based purchasing arrangement pricing structures to identify those that are effective and those needing improvement. It will also assess the potential long-term savings for states participating in these arrangements under Medicaid. A report detailing the study's findings must be submitted to Congress by June 30, 2029.

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MVP Act — S. 1637

Last updated: 5/7/2025 · Introduced: 5/7/2025

Author: Markwayne Mullin (R-OK)

TL;DR (AI)

The bill modifies Medicaid regulations to allow manufacturers to offer multiple price points for drugs under value-based purchasing arrangements, provided they offer them to all states.
It establishes rules for calculating drug prices in Medicaid, considering refunds or rebates based on patient outcomes, and excludes sales under value-based purchasing arrangements from certain price calculations.
The bill requires the Secretary of Health and Human Services to issue guidance to states regarding value-based purchasing arrangements for inpatient hospital services and exempts certain payments related to unsuccessful patient outcomes from the Anti-Kickback Statute.

119th Congressin committeeHR. 7871(In Committee)Official page

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Includes provisions on preamble, short title., and 5 more.

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