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?
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