- The Blue Cross Blue Shield Association (BCBSA) announced Tuesday it will participate in the FDA Payer Communication Task Force (PCTF).
- PCTF was created to speed up approvals of medical devices by allowing pre-submission meetings to help design clinical trials that meet regulatory and medical coverage requirements.
- Partnerships between payers and medical device manufacturers can help to reduce the cost of evidence gathering while improving the quality of data, CMS Acting Administrator Andy Slavitt, FDA Commissioner Robert Califf, and FDA Deputy Commissioner for Medical Products and Tobacco Rachel Sherman wrote in a recent JAMA article.
Before medical devices can be put to practical use, they have to be approved by the FDA and then payers need to decide whether products merit coverage and payment. PCTF helps to ensure that medical device manufacturers design clinical trials to include data needed by payers to make coverage determinations.
Big data could help to reduce the time necessary to approve medical devices being brought to market, according to Slavitt, Califf, and Sherman. EHRs, insurance claims, and clinical registries provide a wealth of data that can improve the diversity of results being examined by the FDA. As the co-authors noted, clinical trials designed by medical device manufacturers are intended to support marketing approval or clearance by the FDA rather than real-life conditions under which products are actually used.
By sharing data, medical device manufacturers and payers like the BCBSA and CMS can help to ensure that regulatory decisions and coverage decisions are streamlined. It is not inconceivable that, in the near future, medical device manufacturers will be able to use shared data sources to conduct more inclusive trials on a wider scale at lower cost, the co-authors wrote.