The ACR recently submitted comments to proposed changes to the Medicare Advantage and prescription drug programs for contract year 2026. Although the proposed rule covers a litany of topics, the ACR’s comments focused on the provisions related to the Inflation Reduction Act (IRA), prior authorization and the influence that pharmacy benefit managers (PBMs) have on the placement of biosimilars on formularies.
It is uncertain whether the Trump administration will finalize many of the proposed rule’s provisions, particularly those focusing on the IRA. Here is a summary of the ACR’s comments on relevant provisions.
Inflation Reduction Act
The proposal would codify prior CMS guidance implementing section 11202 of the IRA, which establishes the Medicare Prescription Payment Plan and requires each Medicare Prescription Drug Plan sponsor and Medicare Advantage prescription drug plan to provide enrollees with the option to pay cost-sharing under the plan in capped monthly amounts. The proposal, which would be applicable for 2026 and subsequent years, aims to ease the financial burden for those with high cost-sharing early in the year. It also builds on prior rulemaking that codified the IRA provision that capped annual out-of-pocket expenses at $2,000. The ACR supports this provision because it will significantly improve access to essential rheumatologic treatments, reduce financial barriers and improve patient outcomes.
The ACR also took the opportunity to strongly encourage the Centers for Medicare & Medicaid Services (CMS) to continue strengthening the IRA, particularly the Medicare Drug Price Negotiation Program (MDPNP). The ACR is extremely concerned about maintaining the MDPNP, particularly due to its positive impact on rheumatology in terms of access to medications, insurance coverage and overall healthcare affordability for patients with chronic rheumatologic conditions.
PBM Influence on Biosimilars
Biosimilars are often seen as a key mechanism for reducing healthcare costs by offering lower-priced alternatives to expensive biologics. However, if rebate-driven formulary decisions limit the use of biosimilars, the anticipated cost savings may not be fully realized. In the long term, this could prevent the healthcare system from benefiting from the potential price reductions that biosimilars can offer.
As such, the ACR supports the CMS’s proposal to implement a more holistic review of Part D plans’ formulary and utilization management practices to determine if the biosimilars listed on their formulary constitute a utilization management program that is cost-effective, reasonable and appropriate, and inclusive of incentives to reduce costs. The ACR has long been a supporter of increasing beneficiary access to biosimilars, which typically provide a lower-cost version of the reference product biologic drugs and are vitally important therapeutic options for patients with rheumatic diseases.
