Press Release

For Immediate Release Contact


Sue Ducat
Director of Communications
(301) 841-9962


Aligning FDA and CMS Review



A new policy brief from Health Affairs and the Robert Wood Johnson Foundation touches on recent initiatives to close gaps between the medical technology evaluation processes of the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). The two agencies have related mandates: the FDA approves drugs and devices that have proven to be “safe and effective,” while CMS authorizes coverage on products that are “reasonable and necessary.” Product sponsors, particularly those of medical devices, have been frustrated by the delays that result because each agency has a different set of required evidentiary standards. The brief focuses on two initiatives—parallel review and coverage with evidence development (CED)—which have the potential to address this bottleneck.

Topics covered by this policy brief include:

    • What’s the background?  The brief details the two review processes. The FDA conducts its review among the narrow population of clinical trial participants. CMS, however, wants a product to benefit the more diverse and varied universe of Medicare patients. The brief explains how the CED initiative, which first began in 1995, can bridge this gap by providing temporary reimbursement for beneficiaries enrolled in clinical studies. Parallel review, launched in 2011 as a pilot program, seeks to shorten the review timeline through increased communication among sponsors, the FDA, and CMS. Devices must meet certain eligibility criteria, outlined in the brief. 
    • What’s the debate? For both programs, CMS resources hold the key to fuller implementation. The Coverage and Analysis Group within CMS, which oversees both programs, has lost about half its staffing since 2007, leading to a reduction in the overall number of national coverage determinations. The brief explains why the two programs have so far failed to reach their potential. For example, some manufacturers remain reluctant to focus their data collection on Medicare’s requirements, while others call for reforms to the program’s eligibility standards.
    • What’s next? The future of both parallel review and CED is uncertain, but, as the brief points out, CMS and the FDA may extend a modified version of parallel review. Current and future budget cuts at CMS and related agencies, and the current political environment, make their future continuation highly questionable, as the brief further explains.