u and your peers may get quicker reimbursements from CMS on newly FDA-approved devices thanks to a just-launched parallel review program, according to a CMS news release. The pilot program would permit both CMS and the FDA to simultaneously review a device for approval and coverage, eliminating the gap between a device’s FDA approval and its coverage under Medicare.
This means that your practice could be offering and, of course, getting paid for services with the latest technology the on which FDA bestows approval.
“Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming,” CMS says in the release. “Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.”
NOTE: The program will not change the review standards for FDA device approval or CMS coverage determination and is only available for qualifying new medical device technologies.
The demo program will not accept more than three to five submissions a year and will last for up to two years, but could be extended.