April 23 (Reuters) – U.S. health regulators on Thursday announced a new program to speed Medicare coverage for certain medical devices, cutting reimbursement timelines to about two months from a year or more.
The Centers for Medicare & Medicaid Services and the Food and Drug Administration said the new RAPID coverage pathway will align regulatory review and Medicare coverage decisions for some FDA-designated Class II and Class III breakthrough devices, which typically include higher-risk medical technologies.
Under the pathway, CMS will issue a proposed national coverage decision on the same day an eligible device receives FDA approval, followed by a 30-day public comment period.
The agencies said the approach is designed to reduce delays between approval and reimbursement.
Medical device makers often face long delays between regulatory approval and Medicare reimbursement and have argued that the lack of a clear reimbursement pathway, unlike for drugs, discourages innovation and investment.
About 40 devices are expected to be initially accelerated for coverage under the program, according to the Financial Times, which first reported on the program.
The decision is a win for large device makers such as Medtronic and Johnson & Johnson, which have lobbied lawmakers to accelerate Medicare coverage for new products.
In 2025, Medtronic generated $33.5 billion in revenue and J&J generated $33.8 billion in medtech sales.
J&J and Medtronic did not immediately respond to a Reuters request for comment.
(Reporting by Siddhi Mahatole and Chandni Shah in Bengaluru; Editing by Sharon Singleton, Sahal Muhammed and Tasim Zahid)
