Legislation & Regulation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) issued the Final Guidance for the Second Cycle of the Historic Medicare Drug Price Negotiation Program for Fiscal Year 2027.

On September 30, 2024, the Centers for Medicare and Medicaid Services (CMS) issued a Decision Memo titled “Final National Coverage Determination (NCD) for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention”

On Sept. 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule on the Medicare Drug Rebate Program (MDRP). Access the Regulatory NewsBREAK to learn more.

On Sept. 13, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a memorandum on Reporting Routing Values for the Medicare Prescription Payment Plan (M3P). Access the Regulatory NewsBREAK to learn more.

On Sept. 13, 2024, the Internal Revenue Service (IRS), Employee Benefits Security Administration (EBSA), and Centers for Medicare & Medicaid Services (CMS) (collectively, the Departments) released a Final Rule on Requirements Related to the Mental Health Parity and Addiction Equity Act (Final Rule). The Final Rule will be published in the Federal Register on Sept. 23, 2024. Access the Regulatory NewsBREAK to learn more.

SB 966, California's PBM reform bill, could reshape pharmacy benefit manager regulation if signed into law. Governor Newsom’s decision is expected by September 30.

AMCP Legislative & Regulatory Briefing — HHS Unveils the Maximum Fair Price for the First 10 Drugs Selected for Medicare Negotiation