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With monumental movement on 340B rebates, changes in Medicare and Medicaid payments, and evolving audit priorities, 2025 has been a transformative year in the world of 340B. We sit down with 340B Health Senior Manager of Policy and Compliance Rebecca Swartz to chronicle some of the biggest developments of such an eventful year and forecast what to expect in 2026.

Rebates Take Shape

Swartz says 2025 will go down as the year that a rebate model shifted from a hypothetical approach pushed by drugmakers into a fully developed model with implementation criteria. The Health Resources & Services Administration (HRSA) approved plans for 340B rebate models set to take effect in January for nine of 10 drugs subject to the 2026 Medicare maximum fair prices. Rebates for the remaining drug on that list will kick in April 1. Swartz discusses how hospitals should prepare for this pilot program, which is set to upend decades of established 340B operations and impose intense financial and logistical burdens on safety-net hospitals nationwide.

Medicaid, IRA Changes Set To Impact 340B Hospitals

This year also saw massive changes to Medicaid funding as well as Medicare pay changes under the implementation of the Inflation Reduction Act (IRA). Swartz says these developments are projected to shrink safety-net hospital margins even further. Renewed congressional focus is putting 340B in a high-profile spot, with potentially significant implications for the program and hospitals in the coming months.

2026 Tips for Hospitals

Swartz says she’s identified two areas as more of a focus for HRSA audits this year: expanded scrutiny of offsite and on-site trial balances and the ways covered entities list shipping addresses. To prepare for possible shakeups in 2026, she recommends that covered entities begin and maintain cross-functional planning across departments and closely monitor denials, delays, and other costs from new rebate programs in addition to monitoring wholesale acquisition cost (WAC) changes and contract pharmacy developments.

Resources

1. 340B Health Year-in-Review Webinar: 2025 Highlights and What’s on the Horizon