MVP Act

This bill would provide legal authority for regulations that allow drug manufacturers to report multiple price points for medications under value-based purchasing arrangements within the Medicaid Drug Rebate Program. These arrangements, often used for high-cost treatments like gene therapies, link the price of a drug to specific clinical outcomes for patients. Additionally, the legislation would exclude these sales from Medicare average price calculations under certain conditions and requires the Government Accountability Office to study how these pricing models impact federal health programs.

This bill affects drug manufacturers participating in the Medicaid Drug Rebate Program and Medicare medical services by altering how drug prices and rebates are calculated under value-based purchasing arrangements. State Medicaid programs and the Centers for Medicare & Medicaid Services are impacted through new requirements for coverage guidance and reporting. Additionally, the Government Accountability Office is required to conduct a study on how these arrangements affect federal health care programs.

• Codification of Value-Based Purchasing Regulations. Provides statutory authority for regulations allowing drug manufacturers to use multiple best price points under value-based purchasing arrangements within the Medicaid Drug Rebate Program. These arrangements link the price of a drug, particularly high-cost treatments like gene therapies, to specific clinical outcomes.
• Medicare Average Sales Price Exemptions. Exempts drug sales made under value-based purchasing arrangements from the calculation of the manufacturer average sales price for Medicare medical services payments. This applies if the manufacturer reports multiple best prices under Medicaid as authorized by the bill.
• GAO Study on Value-Based Purchasing Impacts. Directs the Government Accountability Office to conduct a study on how value-based purchasing arrangements and the bill's specific changes affect federal health care programs.
• Guidance for Inpatient Medicaid Drug Coverage. Requires the Centers for Medicare & Medicaid Services to provide guidance to states on covering drugs in inpatient settings through value-based purchasing arrangements.

The bill provides statutory authority for existing regulations regarding value-based purchasing arrangements within the Medicaid Drug Rebate Program and modifies how drug sales under these arrangements are calculated for Medicare medical services payments. It also requires the Centers for Medicare & Medicaid Services to provide guidance to state Medicaid programs on inpatient drug coverage.

The bill aims to establish statutory authority for value-based purchasing arrangements within the Medicaid Drug Rebate Program, allowing drug prices to be linked to clinical outcomes. It seeks to facilitate these arrangements for high-cost treatments by adjusting how drug prices are calculated and reported under Medicaid and Medicare.