FDA Expands the Parallel Review Program to Private Payors to Expedite Device Access 

For the last few years, FDA has allowed device manufacturers to utilize the Parallel Review Program whereby the manufacturers can have both FDA and CMS review the clinical evidence at the same time in support of both the approval by FDA and the coverage by CMS of a new medical device. This week FDA announced the expansion of the parallel review to include private payers such as insurance companies that can similarly review the clinical evidence in support of coverage. Now with ten major insurance providers participating in this program, it should allow expedited reimbursement and coverage decisions by the payors. Traditionally, the FDA would make an approval decision for new Class III devices first based on the provided review clinical and non-clinical evidence. The FDA positive decision was followed by review by CMS to evaluate if the product merits coverage. Most insurance providers would be the last to make the coverage decisions resulting in a long delay between FDA approval and coverage decisions. The parallel review cuts through the timeline drastically providing faster patient access.