MVP Act

This bill amends the Social Security Act to codify value-based purchasing arrangements under Medicaid and make related reforms to drug price reporting. It allows manufacturers to report multiple best prices for a drug under a value-based purchasing arrangement if offered to all states, adjusts how average manufacturer price is calculated for such arrangements, and excludes certain value-based purchasing remuneration from Medicare average sales price calculations. The bill also requires guidance on value-based purchasing for inpatient drugs, creates an exception under the antikickback statute for certain remuneration under such arrangements, and mandates a GAO study and report on their use.

Sec. 2, Codifying value-based purchasing arrangements under Medicaid and reforms related to price reporting: This section amends Medicaid drug rebate rules to allow manufacturers to report multiple best price points for a single drug under a value-based purchasing arrangement, provided the arrangement is offered to all states. It also clarifies that nothing prohibits treating such an arrangement as a bundled sale. The definition of average manufacturer price is amended to exclude certain refunds, rebates, or payment withholdings triggered by a patient failing to achieve outcomes under a value-based purchasing arrangement. For installment payments under such arrangements, the price is treated as if paid in full in the first installment. The Secretary of Health and Human Services must implement these changes through rulemaking within 180 days. The term 'value-based purchasing arrangement' is defined by reference to existing federal regulations.

Sec. 3, Calculation of average sales price under Medicare: This section amends Medicare Part B drug pricing to exclude from a manufacturer's average sales price any amount that is excluded from average manufacturer price under the new Medicaid rules for value-based purchasing arrangements, but only if the manufacturer has elected to include multiple best price points for that drug.

Sec. 4, Guidance on value-based purchasing arrangements for inpatient drugs under Medicaid: Within 180 days, the Secretary of Health and Human Services must issue guidance to state Medicaid agencies on entering value-based purchasing arrangements with manufacturers for inpatient drugs that are reimbursed directly, not as part of inpatient hospital payments. The guidance must cover how multiple states can enter agreements to transfer funds so patients receiving such drugs in a different state are treated as if they received them in their state of residence.

Sec. 5, Exception under the antikickback statute: This section adds a new exception to the federal antikickback statute for remuneration provided by a manufacturer or third party to a state under a value-based purchasing arrangement when a patient fails to achieve defined outcomes after receiving a covered outpatient drug. The Inspector General of Health and Human Services must implement this through rulemaking within 180 days.

Sec. 6, GAO study and report on use of value-based purchasing arrangements: The Comptroller General must study how value-based purchasing arrangements affect patient access to drugs, patient outcomes, health system costs, and patient costs in federal programs. The study must examine the impact of this Act on access to transformative therapies, socioeconomic disparities, the Medicaid drug rebate program, the 340B program, Medicare Part B, state Medicaid expenditures, and prices in states not entering such arrangements. It must also analyze pricing structures and potential long-term savings for states. A report must be submitted to Congress by June 30, 2028.