Overview

• HHS published guidance August 1 and began accepting applications for a one-year pilot limited to NDC 11 drugs on the Medicare Drug Price Negotiation Selected Drug List.
• Manufacturers with 2026 Medicare negotiation agreements must submit rebate-model plans by September 15 and will learn of approval decisions by October 15 ahead of the January 1, 2026 start date.
• Under the pilot, drugmakers must cover IT costs, provide technical support, and ensure covered entities submit dispensing data within 45 days and receive rebates within 10 days.
• HRSA mandates that manufacturers cannot deny rebates over diversion or Medicaid duplicate discounts and requires comprehensive reporting and audit safeguards.
• The American Hospital Association and 340B Health warned the shift could saddle hospitals with significant financial and administrative burdens and set a concerning precedent.