House Unveils Bipartisan FDA User Fees Package. On May 4, House Energy & Commerce Committee Chair Frank Pallone, Jr. (D-NJ), Ranking Republican Cathy McMorris Rodgers (R-WA), Health Subcommittee Chair Anna G. Eshoo (D-CA) and Health Subcommittee Ranking Republican Brett Guthrie (R-KY) introduced the “Food and Drug Amendments of 2022 Legislation that would reauthorize the Food and Drug Administration (FDA) user fee program. The package extends the Prescription Drug User Fee Act (PDUFA), the Biosimilar User Fee Act (BsUFA), and the Generic Drug User Fee Act (MDUFA), each of which must be renewed every five years.

The bill also includes other FDA-related provisions, including new program integrity initiatives for the FDA accelerated approval pathway that has come under fire after the agency used this process to approve the Alzheimer’s drug Aduhelm. Other provisions would support clinical trial diversity, improve generic drug competition, strengthen supply chains through FDA inspection programs, and more. The Health Subcommittee is scheduled to mark up the legislation next week, with the full committee soon thereafter, with a goal of completing action prior to the August recess. Legislative text here and section-by-section here.

Bipartisan Mental Health Package Introduced. On May 6, Energy & Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Ranking Republican Cathy McMorris Rodgers (R-WA) introduced the “Restoring Hope for Mental Health and Well-Being Act of 2022.” The legislation would reauthorize key Substance Abuse and Mental Health Administration (SAMHSA) and Health Resources and Services Administration (HRSA) programs to address mental health and substance abuse disorder. In addition to reauthorization of a number of youth and mental health and substance abuse disorder programs, the legislation would establish Behavioral Health Crisis Coordinating Office within SAMHSA and require the office to convene partners and provide technical assistance to enhance access. Additionally, the legislation would require self-funded, non-federal government plans to comply with mental health parity laws and improve the integration of evidence-based behavioral health care into primary care settings for mental health and substance abuse disorders. The Health Subcommittee is scheduled to vote on the legislation in a markup next week. Legislative text here and section-by-section here.

Administration

Final Medicare Advantage and Part D Rule Released. On April 29, the Centers for Medicare & Medicaid Services (CMS) released the CY 2023 Medicare Advantage and Part D Final rule. The rule includes multiple changes for MA and Part D plans, including adopting, but delaying by one year until 2024, CMS ‘proposal to change how pharmacy price concessions are accounted for in the definition of negotiated price under Part D, which is the basis of beneficiary cost-sharing. CMS has proposed or issued a request for information from stakeholders on how to account for pharmacy price concessions under Part D on multiple occasions since 2017. CMS estimates the new policy will save beneficiaries $ 26.5 billion and increase manufacturer and government spending by $ 16.8 billion and $ 46.8 billion , respectively, during the 2024-2032 timeframe. CMS notes that Part D sponsors should incorporate these changes in their bids for contract year 2024.

The rule also refines the definitions of fully integrated and highly integrated dual eligible special needs plans, clarifies MA plan obligations during disasters and emergencies, and finalizes changes to network adequacy requirements, medical-loss ratio reporting, Star ratings, and additional requirements for special needs plans.

The final rule can be viewed here. The CMS press release on the rule can be viewed here. The CMS fact sheet on the rule can be viewed here.

Hearings

Unprecedented Leak from the Supreme Court Points to Overturn of Roe v. Wade. On May 2, Politico published a leaked initial draft majority opinion from the US Supreme Court suggesting the Court could overturn Roe v. Wade, the 1973 landmark abortion ruling. If adopted, the draft would rule in favor of a Mississippi law, a case heard by the court in December, and would leave the decision on how to govern abortions up to individual states. The draft written by Justice Samuel Alito is supported by other conservative Justices Brett Kavanaugh, Neil Gorsuch, Amy Coney Barrett, and Clarence Thomas. The leak is only a draft, and the Court made an official statement that the document “does not represent a decision by the Court or the final position of any member on the issues in the case.” The Court’s official opinion is expected to be released before its term ends in two months.

The document has the potential to play a major role in the midterm elections and disrupt legislative action. So far, Republicans have remained focused on the unprecedented breach of protocol, and some have called for an investigation by the FBI to find the person responsible. Democrats are weighing their options to pass federal abortion protections but do not have the 60 votes necessary to override a filibuster. Finally, the Biden Administration has issued statements in support of protecting abortion rights for women but has yet to take concrete action.

Hearings

  • Senate Appropriations Subcommittee held a hearing on May 4, entitled “A Review of the President’s FY 2023 Funding Request and Budget Justification for the Department of Health and Human Services.”

  • Senate Committee on Commerce, Science, & Transportation held a hearing on May 5 on “Ensuring Fairness and Transparency in the Market for Prescription Drugs.”

Quick Hits

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