On October 24, 2016, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) announced that they will be implementing and extending indefinitely the Parallel Review of medical devices pilot program. The two agencies are looking for nominations from manufacturers of innovative medical devices to participate in the program.
Parallel Review Program Is an Effort to Facilitate Earlier Patient Access to Innovative Medical Technologies
CMS and FDA established the Parallel Review pilot program, creating a process for overlapping, rather than sequential, evaluation of clinical evidence for pre-market, FDA-regulated medical devices to reduce the time between FDA marketing approval or FDA’s granting of a de novo request and a Medicare National Coverage Determination (NCD). The program allows the agencies to continue making their pre-market review and coverage decisions consistent with their respective statutory authority. The pre-market review criteria of the FDA and the coverage processes criteria of CMS will not be changed when a device is accepted into the parallel review program.
Notice for voluntary participation in the program occurred in October 2011 and the program was subsequently extended for 2 years in December 2013. CMS and FDA are extending the program indefinitely, transitioning this to a permanent program.
Parallel Review Program Process Consists of Two Different Stages
The Parallel Review program has two stages:
- The pivotal clinical trial design development stage
- The concurrent evidentiary review stage
To submit a request for parallel review prior to the start of the first stage, manufacturers must send an email indicating their interest in the program. Some of the information that must contained in this email contains the nomination of the manufacturer, that the medical device is not excluded by statute from Part A and/or Part B Medicare coverage, and a statement that the medical device addresses the public health needs of the Medicare population. The Agencies plan on reviewing Parallel Review requests and responding with 30 days of receipt of the email, but will prioritize devices that will benefit from the efficiencies of Parallel Review and have the most impact on the Medicare population. In addition, FDA marketing approval does not guarantee a favorable coverage decision.
Manufacturers have the option to withdraw from the program until CMS opens the national coverage determination (NCD) process by posting a tracking sheet. This means that the manufacturer can withdraw from the program after the pivotal trial but before the NCA tracking sheet is posted. However, CMS must complete the statutorily-defined NCD process once the tracking sheet has been posted.
If you have any questions regarding the Parallel Review program, please contact us at 202-558-5272.