Highmark joins FDA's early payor feedback program

PITTSBURGH (January 30, 2023) — Pennsylvania-based Highmark Inc., one of America's leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, has announced that it has joined the U.S. Food and Drug Administration’s (FDA) Early Payor Feedback Program at the Center for Devices and Radiological Health (CDRH).

The Early Payor Feedback Program invites input from payers and other organizations that evaluate clinical evidence to support coverage decisions for medical devices, and that may be interested in providing feedback to device sponsors about the evidence needed to support positive coverage determinations.

“We are extremely proud to join the Early Payor Feedback Program,” said Timothy D. Law Sr., DO, MBA, Chief Medical Officer, Highmark Inc. “Having an opportunity to provide feedback to companies that are developing medical and therapeutic devices is important to us as we work to transform healthcare.”  

Dr. Law added that Highmark routinely evaluates clinical evidence when making coverage decisions, such as its recent decision to cover digital therapeutics for conditions such as substance use disorder, sleep disorders, PTSD and chronic back pain.

“The Early Payor Feedback Program has connected more than 80 medical device companies with payors like Highmark,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA believes that early engagement with payors during the planning phase of medical device clinical trials is important to help advance timely patient access to safe, effective and innovative medical devices.”

CDRH established the Early Payor Feedback Program to facilitate communication between device manufacturers and payors to potentially shorten the time between FDA approval or clearance and coverage decisions. By communicating earlier, manufacturers may design their clinical trials to produce the data required for regulatory approval or clearance and for positive coverage determinations, which may expedite patient access.