Legislation & Regulation

On Feb. 15, 2024, the Centers for Medicare and Medicaid Services (CMS) issued the Medicare Prescription Payment Plan: Draft Part Two Guidance and a Fact Sheet to provide guidance on education and outreach requirements for the Medicare Prescription Payment Plan (M3P), which was established by the Inflation Reduction Act (IRA). AMCP submitted comments in response to this Guidance on March 15, 2024.

In a March 5, 2024 press release, the Department of Health & Human Services (HHS) expressed intent to issue guidance to encourage Medicare Advantage (MA) and Part D plans to relax or remove prior authorization requirements and other utilization management strategies. On March 6, 2024, CMS issued a memo encouraging MA and Part D plans to relax or remove prior authorization requirements in response to the Change Healthcare cyberatack. AMCP sent a letter in response to this guidance on March 8, 2024.

On January 31, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Draft Guidance titled “Draft Part D Redesign Program Instructions (Program Instructions)”, concurrently with the Advance Notice. The Draft Part D Redesign Program Instructions provide draft guidance regarding the implementation of certain Inflation Reduction Act (IRA) provisions relating to the Part D drug benefit. CMS is soliciting comments on all aspects of the Guidance, and notes that policies established in the final Guidance are for 2025. AMCP submitted comments in response to this rule on March 1, 2024.

On January 31, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled “Advance Notice of Methodological Changes for Calendar Year (CY) 2025”. Each year, CMS is required to update MA payment rates and regularly conducts technical updates through the Advance Notice and Rate Announcement process. AMCP submitted comments in response to this rule on March 1, 2024.

On January 30, AMCP joined 24 patient and provider organizations in filing an amicus brief which urges the Supreme Court to reverse the Fifth Circuit's decision in "Alliance for Hippocratic Medicine et al. v FDA et al". The filing organizations believe that the ruling threatens the FDA's role in ensuring Americans' access to safe, effective drugs and treatments.

On December 5, Senate Health, Education, Labor, & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a Request for Information (RFI) titled "Improving Access to Americans' Gene Therapies." On January 22, AMCP submitted a letter in response, which positions the Medicaid VBPs for Patients (MVP) Act of 2023 (H.R. 2666) as a useful tool for improving access to and the affordability of emerging cell and gene therapies. The MVP Act of 2023 codifies the existing “multiple best price” rule that allows manufacturers to report multiple best prices, the lowest drug price paid by any health payer, for drugs that are subject to value-based purchasing arrangements when certain other criteria are met.