Legislation & Regulation

On January 31, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Draft Guidance titled “Draft Part D Redesign Program Instructions (Program Instructions)”, concurrently with the Advance Notice. The Draft Part D Redesign Program Instructions provide draft guidance regarding the implementation of certain Inflation Reduction Act (IRA) provisions relating to the Part D drug benefit.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 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.

On January 17, AMCP joined dozens of other pharmacy organizations in a joint letter which expresses concerns about the FDA's recent authorization of Florida's state drug importation program. The undersigning organizations believe this importation program may lead to the importation of harmful and counterfeit drugs into the United States, with little evidence of cost savings. The organizations remain committed to alleviating the high cost of medicines in the United States, but oppose state drug importation programs that may compromise patient safety.

On Jan. 11, AMCP joined with 65 other healthcare organizations in a sign-on letter urging the Biden Administration to implement policies that would stabilize and support a strong, sustainable Medicare Advantage program for its beneficiaries. The letter comes as the Administration and CMS continue to enact significant policy changes to the Medicare Advantage program, which serves 51 percent of the Medicare population.