LeAnn Golding, MA, a recent graduate from the University of Virginia’s Frank Batten School of Leadership and Public Policy, completed a capstone project assessing the potential impact of various policy options on the delay of reimbursement that occurs between approval by the US Food and Drug Administration (FDA) and a positive coverage decision by the Centers for Medicare and Medicaid Services (CMS).
The current process for obtaining reimbursement following FDA device approval takes too long and leaves many patients without access to life-changing medical therapies. While the FDA has made great strides to increase transparency and support manufacturers that are navigating the approval process, the CMS reimbursement process remains a significant hurdle for making safe and effective devices available to the public.
Ms. Golding’s project evaluated several policy options, including: (1) letting the present trends of CMS reimbursement following FDA approval continue; (2) expanding the Parallel Review Program to include Local Coverage Determinations; (3) amending the Breakthrough Devices Program to include products that are already in the FDA approval process and fast-tracking these devices through the CMS reimbursement process; or (4) implementing a new process that allows for immediate coverage and reimbursement following FDA approval.
Ms. Golding evaluated these alternatives based on the risk posed to patients, the ease of implementation, the political feasibility, and the cost effectiveness. Which option received the highest recommendation?