The EPIC Act of 2025 amends Title XI of the Social Security Act to change when drugs become subject to price negotiation under the Medicare Drug Price Negotiation Program. Specifically, it creates a two-phase, phased-in schedule for the minimum time that must pass between a drug’s FDA approval and when its price can be subject to Medicare negotiation. For initial price applicability years 2026 and 2027, the minimum elapsed time is 7 years; beginning in 2028 and in subsequent years, the minimum elapsed time increases to 11 years. The bill’s stated purpose is to equalize the negotiation timeline for small-molecule drugs and biologics, ensuring a harmonized point at which negotiated prices may apply based on how long a drug has been approved. In short, the bill delays or phases in when new drugs start facing Medicare price negotiation, with an aim to align the timing between drug classes and potentially influence the balance between innovation incentives and patient access to negotiated prices.
Key Points
- 1The bill’s short title is the Ensuring Pathways to Innovative Cures Act of 2025 (EPIC Act of 2025).
- 2It amends Section 1192(e)(1)(A)(ii) of the Social Security Act to adjust the “initial price applicability year” for drugs under the Drug Price Negotiation Program.
- 3For initial price applicability years 2026 and 2027, the minimum time elapsed since FDA approval before price negotiation can apply is at least 7 years.
- 4For initial price applicability year 2028 and every year thereafter, the minimum time elapsed since FDA approval before price negotiation can apply is at least 11 years.
- 5The change is framed as equalizing the negotiation period between small-molecule and biologic drug candidates, aligning the timing of price negotiation across drug types.