• Posted April 24, 2026

New Plan Could Speed Medicare Coverage for Innovative Devices

A new proposal could make it easier for patients to access breakthrough medical devices through Medicare.

On Thursday, federal regulators announced a plan they’re calling RAPID. 

The goal? To better coordinate how the U.S. Food and Drug Administration (FDA) and Medicare review these new innovative devices. FDA determines whether devices are safe, and Medicare decides whether to cover them.

Under the RAPID pathway, companies would work with Medicare earlier in the process. The aim is to gather and review sufficient data before determining that Medicare can cover products soon after they reach the market. 

“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,” Medicare Deputy Administrator John Brooks told STAT News. “And that’s enormously valuable, if you think about the investment timelines for device manufacturers who are trying to bring life-saving treatments to individuals.”

The FDA’s breakthrough devices program, launched in 2016, has already authorized more than 1,200 devices. Of those, 185 have been approved for use as of the end of last year, STAT News reported.

But many companies say getting Medicare to pay for those devices takes far too long.

“Ideally, this would increase the amount of evidence we will have for these devices, making sure they’re more relevant to Medicare beneficiaries,” said Dr. Kushal Kadakia, a resident physician at Massachusetts General Hospital in Boston. “From an innovation access perspective, it’s nice for these processes to be aligned up front.” 

But the program won’t guarantee automatic payment, which many officials have repeatedly pushed for.

“While we appreciate this first step toward improving coverage, it is critical that the implementation of such a proposal is effective,” said Scott Whitaker, president and CEO of device industry trade group AdvaMed. “Without meaningful timelines, accountability and effective management of this program, patients are unlikely to see the full benefits of new technologies."

Officials estimate that about 40 devices could qualify for the RAPID pathway right now. It will apply to both moderate-risk (Class II) and high-risk (Class III) devices.

Some experts also worry about how the program will balance the safety with speed.

“The question is: In trying to reach this greatest common denominator for evidence, does that raise or lower the bar for the evidence that we have for devices that come to market?” Kadakia said.

More information

Learn more about RAPID at the U.S. Food and Drug Adminstration.

SOURCE: STAT News, April 23, 2026