The FDA launched a quality assurance program to solicit commercial payers' feedback on medical device coverage requirements, HealthPayerIntelligence reports.
Here are five takeaways:
1. Through the Private Payor Program, medical device manufacturers will use feedback from FDA, payers and private technology assessors to expedite approval processes. The FDA believes the faster approval process will allow payers to add new medical devices onto formularies sooner.
2. Five payers are participating in the program: CareFirst BlueCross BlueShield, the BlueCross BlueShield Association, Humana, Kaiser Permanente and UnitedHealth Group.
3. The PPP already helped initiate 10 engagements between commercial payers and manufacturers.
4. The FDA developed the PPP because it often takes years to acquire both FDA approval and payer coverage, which negatively impacts patient safety and smaller medical device companies that need the revenue stream, said FDA Commissioner Scott Gottlieb, MD.
5. The FDA also updated medical device communications between payers, formulary committees and other stakeholders to facilitate the exchange of economic and safety information.
"We're focused on ensuring efficient, timely access to new technologies; but also to make sure that the same policies that promote these goals also make our regulatory programs more rigorous, more science-based, and more effective. Promoting product safety is a touchstone for all of our new policy efforts," Dr. Gottlieb said.