The Trump administration unveiled a new program to speed up Medicare coverage for breakthrough devices, touting that the new pathway cuts red tape for medical device companies to gain reimbursement.
The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for FDA-designated Class II and Class III breakthrough devices.
The new pathway creates better alignment between FDA review of medical devices and Medicare coverage decisions, John Brooks, CMS Deputy Director and Chief Policy and Regulatory Officer, and Senior Counselor of the U.S. Department of Health and Human Services, told reporters during a press call Thursday morning.
The RAPID pathway is designed to accelerate access to certain FDA-designated Class II and Class III devices for people with Medicare coverage.
“It presents an unprecedented alignment and coordination between CMS and FDA as well as we’ll be working with manufacturers immediately by the beginning of the IDE (Investigational Device Exemption) process,” Brooks said. “CMS will coordinate with FDA to provide guidance to manufacturers to help them understand what targets they need to hit in order to achieve coverage immediately upon approval in the CMS program. Under this program, basically, 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.”
Launched by the FDA in 2015, the Breakthrough Device designation expedites the FDA review process for devices that are novel and could provide more effective treatment for severe conditions.
As of December 31, 2025, the FDA’s Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) have granted 1,246 breakthrough device designations.
CMS is now pausing the existing Transitional Coverage for Emerging Technologies (TCET) program for new candidates as CMS focuses on the successful implementation of the RAPID coverage pathway, the agency said in a press release.
A CMS senior official told reporters on the press call that the RAPID program differs from the TCET program as the agency will be working more closely with the FDA and device manufacturers earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions. The new coverage pathway is designed to significantly reduce delays that have historically occurred between FDA market authorization and Medicare national coverage determinations.
“The Breakthrough program has been a great success and its history thanks to the great folks at CDRH, and increasingly, we have heard from innovators on the medical device space that FDA may no longer be the biggest concern as then, how do they get coverage on the back end after clearance?,” said Grace Graham, FDA Deputy Commissioner for Policy, Legislation, and International Affairs and Senior Counselor of the HHS, during the press call.
The RAPID coverage pathway is for Breakthrough Devices that address unmet medical needs among Medicare beneficiaries and is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program (TAP) and Class III devices regardless of whether they are participating in TAP. To be eligible for the RAPID coverage pathway, devices must be the subject of an Investigational Device Exemption (IDE) study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS.
This new program will link device manufacturers to CMS experts early in development to understand what clinical outcomes are most relevant for Medicare beneficiaries, Trump administration officials said. A coordinated approach allows CMS and the FDA to rely on premarket evidence to inform both the FDA premarket review and Medicare coverage processes.
For several years, CMS, under both the first Trump administration as well as the Biden administration, has tried to align reimbursement for novel medical devices with the FDA’s Breakthrough Device program.
In 2021, under the Trump administration, CMS introduced the Medicare Coverage of Innovative Technology (MCIT) rule, providing four years of automatic, national Medicare coverage upon FDA authorization. The Biden administration then scrapped that rule and finalized the Transitional Coverage for Emerging Technologies (TCET) program in 2024 as a Medicare payment pathway.
Many stakeholders in the medical device market have criticized the time lapse between FDA market authorization and CMS coverage determinations. Under the TCET program, CMS did not work with the FDA and medical device companies before the trial design so there was misalignment with generating data to support the Medicare coverage determination process, a CMS senior officials said on the call.
By joining forces, the FDA and CMS can better align evidence expectations earlier in the process to reduce duplication and improve efficiency, officials said.
The new pathway program also will enable CMS to approve more medical devices for Medicare coverage by leveraging existing processes, resources and expertise through the FDA, the senior CMS official said on the call. Currently, there are 40 devices that would qualify for the RAPID pathway and CMS leaders estimate an additional 20 devices could participate. Under TCET, CMS capped the program to about five products every year, the senior official said.
The RAPID program provides more transparency for device manufacturers as they approach the FDA and CMS, Brooks said.
“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, 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,” he said.
The program also marks a tighter collaboration between FDA and CMS as data submitted to the FDA will be shared with CMS in real time, Brooks noted.
Medical devices approved for the RAPID pathway would receive permanent Medicare coverage, officials said, as opposed to the MCIT program that provided coverage for only four years.
“FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned sooner in that process,” CMS Administrator Dr. Mehmet Oz said in a statement. “The RAPID coverage pathway brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster.”
The president and CEO of industry group AdvaMed, Scott Whitaker, said the new pathway is a positive step toward expanding Medicare beneficiaries’ access to the FDA-authorized, safe and effective breakthrough medtech.
“While we appreciate this first step toward improving coverage, it is critical that the implementation of such a proposal is effective. Without meaningful timelines, accountability and effective management of this program, patients are unlikely to see the full benefits of new technologies. We look forward to continuing our work with CMS to ensure Medicare beneficiaries have full, timely access to all the lifesaving, life-changing benefits breakthrough medtech offers—as soon as possible after FDA clearance,” Whitaker said in a statement to Fierce Healthcare.
In a statement, Medical Device Manufacturers Association’s (MDMA) President and CEO Mark Leahey said the RAPID coverage pathway “holds significant promise to alleviate the problem of delayed access for Medicare beneficiaries to the newest medical devices and diagnostic tests, and to strengthen the United States’ position as the global leader in medical technology.”
“We look forward to working with Secretary Kennedy, Administrator Oz, Commissioner Makary, Congress and other stakeholders to finalize and implement this new coverage pathway, and to achieve our shared goal of accelerating the development of the diagnostics, therapies, and cures that our nation’s seniors urgently need,” Leahey said.
Some industry sources noted that the RAPID coverage pathway is similar to the parallel review process, which many contend has not been a successful model. Implemented in 2016, the parallel review progra,\m created a pathway that allowed FDA and CMS to simultaneously review pivotal clinical data and decrease the time between FDA’s approval of a premarket application and the subsequent CMS national coverage determination.
In its most recent proposed Medicare payment rule for hospitals, CMS proposed to repeal the alternative pathway for New Technology Add-on Payments (NTAP) and Outpatient Prospective Payment System device pass-through applications for breakthrough medical devices.
“As we have gained experience, we have concerns with the limited evaluation process for alternative pathway applications for new technology add-on and OPPS device pass-through payments, and after further consideration, we believe it is in the best interest of Medicare patients to refine our approach, to ensure that all new technologies approved for new technology add-on payment have demonstrated that the technology is not substantially similar to existing technologies and represents an advance that substantially improves, relative to technologies previously available, the diagnosis or treatment of Medicare beneficiaries,” CMS wrote in the Hospital Inpatient Prospective Payment Systems proposed rule.
Devices that receive this supplemental payment should demonstrate “substantial clinical improvement,” CMS wrote.
AdvaMed said it was concerned with CMS’s recent proposal to repeal the New Technology Add-on Payments (NTAP), asserting that many hospitals “cannot afford to offer patients procedures involving FDA-authorized breakthrough medtech without these already-modest, temporary payments.”
“We will continue to work closely with CMS to shore up the NTAP program and its critical role in serving Medicare beneficiaries,” Whitaker said. “It is important to remember who is on the receiving end of these statutorily defined ‘breakthrough’ medical technologies that have gone through the rigorous FDA review process: patients in need who currently lack medical options for the conditions from which they are suffering—and their expert doctors and care teams seeking the best medicine has to offer in order to alleviate that suffering.”