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.
About Highmark Inc. One of America's leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, Highmark Inc. (the Health Plan) and its affiliated health plans (collectively, the Health Plans) work passionately to deliver high-quality, accessible, understandable, and affordable experiences, outcomes, and solutions to customers. As the fourth largest overall Blue Cross Blue Shield-affiliated organization, Highmark Inc. and its Blue-branded affiliates proudly cover the insurance needs of approximately 6.8 million members in Pennsylvania, Delaware, New York and West Virginia. Its diversified businesses serve group customer and individual needs across the United States through dental insurance and other related businesses. For more information, visit www.highmark.com.
All references to “Highmark” in this document are references to the Highmark company that is providing the member’s health benefits or health benefit administration and/or to one or more of its affiliated Blue companies.
This website is operated by Highmark, Inc. and is not the Health Insurance Marketplace website. It also does not display all Qualified Health Plans available through the Health Insurance Marketplace website. To see all available Qualified Health Plan options, go to the Health Insurance Marketplace website at HealthCare.gov.
Highmark Blue Cross Blue Shield or Highmark Blue Shield are Medicare Advantage HMO, PPO, and/or Part D plans with a Medicare contract. Enrollment in these plans depends on contract renewal.
®Blue Cross, Blue Shield and the Cross and Shield symbols are registered service marks of the Blue Cross Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. Benefits and/or benefit administration may be provided by or through the following entities, which are independent licensees of the Blue Cross Blue Shield Association: Western and Northeastern PA: Highmark Inc. d/b/a Highmark Blue Cross Blue Shield, Highmark Choice Company, Highmark Health Insurance Company, Highmark Coverage Advantage Inc., Highmark Benefits Group Inc., First Priority Health, First Priority Life or Highmark Senior Health Company. Central and Southeastern PA: Highmark Inc. d/b/a Highmark Blue Shield, Highmark Benefits Group Inc., Highmark Health Insurance Company, Highmark Choice Company or Highmark Senior Health Company.
PA: Your plan may not cover all your health care expenses. Read your plan materials carefully to determine which health care services are covered. For more information, call the number on the back of your member ID card or, if not a member, call 866-459-4418.
Delaware: Highmark BCBSD Inc. d/b/a Highmark Blue Cross Blue Shield.
West Virginia: Highmark West Virginia Inc. d/b/a Highmark Blue Cross Blue Shield, Highmark Health Insurance Company or Highmark Senior Solutions Company. Visit our website to view the Access Plan required by the Health Benefit Plan Network Access and Adequacy Act. You may also request a copy by contacting us at the number on the back of your ID card.
Western NY: Highmark Western and Northeastern New York Inc. d/b/a Highmark Blue Cross Blue Shield.
Northeastern NY: Highmark Western and Northeastern New York Inc. d/b/a Highmark Blue Shield.
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