STAT+: Medicare finalizes reimbursement rule for breakthrough medical devices
The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical device makers.
Called Transitional Coverage for Emerging Technologies, the program gives device makers with products deemed “breakthrough” technology by the Food and Drug Administration a quicker way to secure Medicare coverage. The agency first introduced the rule last June.
The final version of the rule appeared similar to the draft introduced last year, though it more explicitly promises to offer a coverage decision six months after FDA authorization. The agency anticipates accepting five device makers each year into the program. All must be a part of the FDA’s breakthrough devices program, which has so far shown the biggest gains for device companies though it’s primarily meant to benefit patients.
