On July 31, 2026, the Health Resources and Services Administration (“HRSA”) announced a revised 340B Rebate Model Pilot Program (“2026 Pilot”) to provide a rebate mechanism through which qualifying manufacturers may effectuate the 340B ceiling price for certain drugs sold to covered entities—as opposed to an upfront discount, which has been the longstanding model. The 2026 Pilot, which is limited to the drugs selected for negotiation under Medicare, is open to qualifying manufacturers that submit plans meeting specific criteria.
On June 16, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule, “Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program” (“Proposed Rule”), to codify the Medicare Drug Price Negotiation Program (“Negotiation Program” or “MDPNP”) and to establish new policies with respect to the MDPNP, for initial price applicability year 2029 and subsequent years.
In this episode of the Diagnosing Health Care Podcast: The Inflation Reduction Act (IRA), signed into law in August 2022, included significant and controversial drug-pricing provisions.
What key compliance issues must industry stakeholders consider as these provisions are put into effect?
On this episode, Epstein Becker Green attorneys Leslie Norwalk, Connie Wilkinson, and Alexis Boaz discuss key considerations for the health care and life sciences industry as the Centers for Medicare & Medicaid Services works its way through the initial stages of ...
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