U.S. health regulators announced a new program to speed up Medicare coverage for certain medical devices on Thursday. They said 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. They have argued that the lack of a clear reimbursement pathway discourages innovation and investment. Unlike drugs, devices lack this pathway. Therefore, the Medicare device coverage program addresses a long-standing industry complaint.
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. It applies to some FDA-designated Class II and Class III breakthrough devices. These typically include higher-risk medical technologies. The agencies said the approach is designed to reduce delays between approval and reimbursement.
Coverage Within 60 to 90 Days of FDA Approval
“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 John Brooks told reporters. CMS will issue a proposed national coverage decision on the same day an eligible device receives FDA approval. This will be followed by a 30-day public comment period. Therefore, the Medicare device coverage timeline becomes predictable and rapid.
Regulators expect about 40 devices to be initially eligible for accelerated coverage, said FDA Deputy Commissioner 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.”
A Win for Large Device Makers
The program represents a win for large device makers such as Medtronic and Johnson & Johnson. These companies have lobbied lawmakers to speed up Medicare coverage for new products. In 2025, Medtronic generated $33.5 billion in revenue. Johnson & Johnson generated $33.8 billion in medtech sales. “Improving access to new treatments is critical to helping patients overcome complex health conditions,” a Medtronic spokesperson told Reuters. “We are encouraged by the latest CMS and FDA commitment to rapid and predictable coverage pathways.”
The Medicare device coverage program could also benefit smaller device makers. Startups often struggle to survive the long gap between FDA approval and Medicare reimbursement. That gap has forced some to seek funding from venture capitalists on unfavorable terms. Others have abandoned promising technologies altogether. The new pathway reduces this risk.
Why Medicare Coverage Matters
Medicare is the federal health insurance program for Americans aged 65 and older. It also covers younger people with disabilities. Approximately 65 million Americans are enrolled in Medicare. Without Medicare coverage, many seniors cannot afford new medical devices. Therefore, FDA approval alone is insufficient. A device must also receive Medicare reimbursement to reach most patients.
The previous system created a “valley of death” for medical device innovation. A company might spend years and hundreds of millions of dollars on clinical trials. It would receive FDA approval. Then it would wait another year or more for Medicare to decide on coverage. During that waiting period, the company earned no revenue. Investors became reluctant to fund device startups. The Medicare device coverage program solves this problem by aligning the timelines.
Implementation and Oversight
The RAPID pathway is voluntary. Device makers can choose whether to participate. Those that do must meet specific data requirements. The FDA and CMS will coordinate closely during the review process. The public comment period allows physicians, patients, and other stakeholders to provide input. CMS will consider this input before issuing final coverage decisions.
The program launches immediately. Regulators expect the first devices to receive accelerated coverage within months. The Medicare device coverage program could serve as a model for other health agencies. Private insurers often follow Medicare’s lead on coverage decisions. Therefore, the impact could extend beyond the 65 million Medicare beneficiaries. The program has broad bipartisan support. Lawmakers from both parties have criticized the previous delays. The FDA and CMS acted without new legislation. They used existing authorities to create the RAPID pathway. The Medicare device coverage program thus represents administrative action rather than new law. Patients will likely benefit from faster access to innovative devices. Device makers will face less financial uncertainty. The program appears to be a rare win-win in American health policy. The coming years will reveal whether the 60-to-90-day timeline proves achievable in practice. For now, the Medicare device coverage program has raised industry hopes.
