By Ahmed Aboulenein, Sneha S K and Siddhi Mahatole
WASHINGTON, April 23 (Reuters) – U.S. health regulators announced a new program to speed up Medicare coverage for certain medical devices on Thursday, saying it would cut reimbursement timelines to as little as two months from a year or more.
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.
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.
The agencies said the approach is designed to reduce delays between approval and reimbursement.
“Under this program, CMS will be able to provide coverage within 60 to 90 days of FDA approval across the Medicare population for new devices that offer promising therapies for individuals,” CMS Deputy Administrator and Chief Policy and Regulatory Officer John Brooks told reporters on a press call.
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.
Regulators expect about 40 devices to be initially eligible for accelerated coverage, said FDA Deputy Commissioner for Policy, Legislation, and International Affairs Grace Graham.
The types of devices affected include artificial heart valves, devices that treat heart rhythms, and implants that stimulate nerves to treat diseases, Brooks said.
“There’s just going to be a lot more transparency for device manufacturers as they approach the FDA and CMS,” he added.
“We’re going to demystify the process by providing a clear signal to device manufacturers of exactly what targets they need to hit to get Medicare coverage,” Brooks said.
The program represents a win for large device makers such as Medtronic and Johnson & Johnson, which have lobbied lawmakers to speed up Medicare coverage for new products.
In 2025, Medtronic generated $33.5 billion in revenue and J&J generated $33.8 billion in medtech sales.
“Improving access to new treatments is critical to helping patients overcome complex health conditions, and we are encouraged by the latest CMS and FDA commitment to rapid and predictable coverage pathways,” a Medtronic spokesperson told Reuters.
J&J did not immediately respond to a Reuters request for comment.
(Reporting by Siddhi Mahatole, Chandni Shah, and Sneha S K in Bengaluru, Ahmed Aboulenein in Washington; Editing by Alexander Smith and Maju Samuel)
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