Payers join new FDA program to expedite medical device coverage

Health insurers want to participate in a new federal program designed to shorten the time between FDA approval and coverage decisions for medical devices.

BlueCross BlueShield Association, CareFirst BlueCross BlueShield, Humana, Kaiser Permanente and United Health Group have all joined the Food and Drug Administration’s growing list of healthcare insurance companies participating in the program and attending medical device manufacturer pre-submission meetings.

In addition, healthcare technology assessment organizations such as Duke Evidence Synthesis Group, ECRI Institute, and the National Institute for Health and Care Excellence are among the participants.

So far, there have been 10 engagements between private payers or HTA groups and device vendors, including four pre-submission meetings, according to FDA Commissioner Scott Gottlieb, MD.

The purpose of these meetings is to facilitate communications between device makers and payers, Gottlieb notes, thereby expediting the agency’s regulatory review process and coverage from insurers—which, all told, can currently take several years to complete.

“The FDA believes that early engagement with manufacturers and payers during the planning phase of medical device clinical trials will expedite patient access to high quality, safe and effective medical devices,” wrote Gottlieb in a blog last week. “In streamlining the process, our goal is to improve coordination so that access to approved products can be achieved without unnecessary delay.”

According to Gottlieb, the benefit of the new program for payers is that they are able to learn about new technologies “beyond their current horizon scanning” and can “provide suggestions about what data and analyses would be useful for evaluation, gaining insight and increased understanding of the FDA review process.”

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Because device manufacturers are engaging early in the process with payers when it comes to “discussions about evidentiary needs” the vendors are “able to consider and address coverage-related issues earlier in the process, and gaining the potential for earlier reimbursement through earlier engagement with payers.”