The proposed rule also included a request for information on the influence that PBMs have on biosimilar placement in formularies. As many members know, the ACR is co-leading the Underwater Biosimilars Coalition with the Coalition of State Rheumatology Organizations, whose goal is to amend current statute so that providers infusing biosimilars will no longer be reimbursed at levels lower than the acquisition cost. This scenario is largely created by the rebates drug manufacturers offer to PBMs in exchange for prime formulary placement of the payers’ preferred drugs. The ACR’s letter reiterated the Coalition’s desire for the CMS to work with Congress on legislation that would address the matter.
Strengthening Prior Authorization in Medicare Advantage
The CMS is proposing significant beneficial reforms to the prior authorization process in Medicare Advantage (MA), requiring plans to adopt electronic systems for streamlining requests, maintain approvals for the duration of treatment and ensure that clinical decisions are made based on evidence-based guidelines. Specifically, the CMS is proposing the following:
- Define “internal coverage criteria” and clarify that MA plans may only apply such criteria when Medicare coverage policies are insufficient. Any such criteria must be:
- Publicly available and transparent;
- Based on current evidence and widely accepted guidelines from recognized professional medical societies or consensus-based organizations; and
- Consistent with Medicare’s regulatory requirements.
- Require that once a prior authorization is approved, it remains valid for the entire course of treatment, preventing the need for repeated approvals and ensuring continuity of care.
- Mandate that plans provide specific reasons for coverage denials, including the exact Medicare or plan coverage rule or guideline used in the determination, and a detailed explanation of how the criteria were applied.
The ACR supports these proposals.
ACR/ARP members should email the ACR’s advocacy team at [email protected] with any questions and comments they may have. We will monitor the rule’s implementation and serve as an educational resource for members on its provisions and the impact they will have on rheumatology.
