Included in the Inflation Reduction Act in 2022, the Medicare Drug Price Negotiation program is making a meaningful impact on rheumatology, especially for Medicare beneficiaries. Patients are benefiting from significantly lower prices on key biologics and improved access to treatment. The ACR has been a committed supporter of the program and several ACR members have shared expertise with the program.
Earlier this spring, Rebecca Shepherd, MD, MBA, and Amanda Myers, MD, presented to the Centers for Medicare & Medicaid Services (CMS) the value that Otezla and Ofev (both of which were selected for the second round of negotiations) have in treating patients with rheumatologic diseases.
The program is now entering its third round of negotiations, and the new list of 15 drugs will be released on Feb. 1, 2026. ACR members should be aware of several upcoming changes to the program.
Part B Drugs Are Coming into Negotiation
The CMS released draft guidance in May that started the process to include high-expenditure Part B drugs in the third round of negotiations (prices effective in 2028). That puts office-administered biologics commonly used in the rheumatology space (e.g., infliximab, abatacept, tocilizumab and rituximab) in the potential crosshairs for future selection.
Change in Average Sales Price Methodology Could Lower Reimbursement Rates
In the CY 2026 Physician Fee Schedule proposed rule, the CMS clarifies that units sold at the maximum fair price (MFP) must be included in manufacturers’ average sales price (ASP) calculations starting Jan. 1, 2026. If a drug has MFP sales, its ASP can drift lower, reducing Medicare’s payment basis (generally ASP + 6%). Because many rheumatologists operate under the buy-and-bill model, this could lower drug reimbursement to rheumatology practices over time. For the many practices are already strained financially, particularly those in rural and other underserved areas, lower reimbursement could lead to some difficult choices when it comes to patient care.
Prices for Some Part D Drugs May Drop in 2026
The first round of negotiated prices, which go into effect in January 2026, include Enbrel and Stelara, both relevant to rheumatology. Public reporting shows large list-to-negotiated price reductions for both drugs. This could reduce patient out-of-pocket costs and as a result may improve adherence.
Conclusion
The ACR continues to be a strong advocate for the Medicare Drug Price Negotiation program and other policies or programs that our membership feels will reduce drug prices. We will continue to inform members about changes to the program and to look for additional ways that members can provide their expertise on patient care to the CMS. For further information about the ACR’s regulatory advocacy efforts, email the ACR’s advocacy team at [email protected]. ACR/ARP members can also schedule a time to meet directly with the ACR’s advocacy team to discuss issues and challenges you are facing.
