Perspectives on Medicare Policies
By JR Associates
SUBJECT: Medicare Physician Fee Schedule Rule: Proposed Changes for the Process for Covering Items and Services in an Investigational Device Exemption (IDE), Centers for Medicare and Medicaid Services (CMS) 78 Fed. Reg. 43282, 43342-47, 43523-25 (July 19, 2013)
OVERVIEW: JR Associates is concerned about CMS’ proposed changes to the coverage process for medical devices that are studied in IDE clinical trials. We believe that this process is best managed at the local Medicare contractor level, as is currently the case. Continuing the existing structure ensures that Medicare beneficiaries can participate in clinical trials for innovative, beneficial technologies without concern for denial of routine care and other services.
RATIONALE: The proposed changes could limit the number of trials that will be eligible for coverage, and may dissuade trial sites and Medicare beneficiaries from participating in clinical trials. CMS should consider opportunities to improve the clinical trial approval process at the contractor level, and work to ensure that this process is more efficient and consistent.
RECOMMENDATION: We recommend delaying a final decision, and convening a task force of stakeholders — including appropriate federal and local contractor agencies, large and small manufacturers who sponsor trials, and a mix of academic and non-academic institutions that participate as trail sites. This will allow for public participation as the current system and potential modifications are reviewed.