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AMCP Regulatory NewsBreaks

April 5, 2023: CMS Issues Final Part D Bidding Instructions for 2024

Substance Abuse and Mental Health Services Administration (SAMHSA) within the Department of Health and Human Services (“HHS”) issued a final rule on Medications for the Treatment of Opioid Use Disorder (Final Rule), to be published on Feb. 2, 2024.
AMCP Regulatory NewsBreaks

March 16, 2023: CMS Releases Initial Guidance for Medicare Drug Price Negotiation Program

On March 15, the Centers for Medicare & Medicaid Services (CMS) released initial guidance for key elements of the new Medicare Drug Price Negotiation Program. This guidance describes how CMS intends to implement the Negotiation Program for initial price applicability year 2026 (Jan. 1, 2026 to Dec. 31, 2026), the first year the negotiated prices will apply.
AMCP Regulatory NewsBreaks

Feb. 9, 2023: CMS Posted Information Collection Materials for the New Manufacturer Discount Program

The Inflation Reduction Act (IRA) requires the establishment of a new Medicare Part D manufacturer discount program (MDP) beginning Jan. 1, 2025 and requires participating manufacturers to enter into agreements with CMS by Mar. 1, 2024 in order to participate in the MDP in 2025. Agreements will be valid for not less than one year and automatically renew unless terminated by CMS or the manufacturer.
AMCP Regulatory NewsBreaks

Feb. 6, 2023: CMS Released the RADV Final Rule

On Feb. 1, the Final Rule, titled Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of AllInclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021, was published in the Federal Register.