The Trump administration has announced a new program to accelerate Medicare coverage of breakthrough devices, touting the new pathway as a way for medical device companies to cut through red tape to obtain reimbursement.
The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) on Thursday announced regulatory alignment for the FDA-designated Predictable and Immediate Device (RAPID) coverage pathway for Class II and Class III breakthrough devices.
John Brooks, CMS deputy commissioner and chief policy and regulatory officer and senior advisor to the U.S. Department of Health and Human Services, said in a press conference Thursday morning that the new pathway will improve coordination between FDA medical device reviews and Medicare coverage decisions.
The RAPID Pathway is designed to accelerate access to certain FDA-designated Class II and Class III devices for Medicare enrollees.
“This will result in unprecedented coordination and coordination between CMS and FDA to immediately work with manufacturers to begin the IDE (Investigational Device Exemption) process,” Brooks said. “CMS is working with FDA to provide guidance to help manufacturers understand what goals they need to meet to achieve immediate coverage after approval in the CMS program. This program essentially allows CMS to provide coverage to the entire Medicare population within 60 to 90 days of FDA approval for new devices that provide promising treatments to individuals.”
Breakthrough device designation, initiated by the FDA in 2015, expedites the agency’s review process for devices that have the potential to provide more effective treatments for novel and serious conditions.
As of December 31, 2025, FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have granted 1,246 breakthrough device designations.
CMS is currently suspending the existing Emerging Technology Transition Coverage (TCET) program for new candidates as it focuses on successfully implementing the RAPID application pathway, the agency said in a press release.
CMS officials said at a press conference that the RAPID program, unlike the TCET program, will work more closely with FDA and device manufacturers early in the technology development lifecycle to ensure that the evidence generated for FDA review can support Medicare coverage decisions. The new coverage pathway is designed to significantly reduce the delays that have previously occurred between FDA market authorization and Medicare national coverage determinations.
“The Breakthrough Program has been a huge success, and its history is indebted to the great people at CDRH.Increasingly, we are hearing from innovators in the medical device industry that FDA may no longer be their top concern as it was back then, and how they will be covered on the back end after approval,” Grace Graham, FDA’s deputy commissioner for policy, legislative and international affairs and HHS senior adviser, said at a press conference.
The RAPID Coverage Pathway is for innovative devices that address unmet medical needs among Medicare beneficiaries and is available for certain Class II devices participating in the FDA Total Product Lifecycle Advisory Program (TAP) and Class III devices regardless of whether they participate in the TAP. To qualify for the RAPID coverage pathway, a device 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.
Trump administration officials say the new program will bring device manufacturers and CMS experts together early in development to understand what clinical outcomes are most relevant to Medicare beneficiaries. A coordinated approach allows CMS and FDA to rely on premarket evidence to inform both FDA’s premarket review and the Medicare coverage process.
For years, CMS has sought to align reimbursement for new medical devices with the FDA’s Breakthrough Devices Program, both under the first Trump and Biden administrations.
In 2021, under the Trump administration, CMS introduced the Medicare Coverage of Innovative Technologies (MCIT) rule, which provided four years of automatic national Medicare coverage upon FDA approval. The Biden administration subsequently repealed that rule and completed the Emerging Technology Transition Coverage (TCET) program in 2024 as a payment pathway for Medicare.
Many stakeholders in the medical device market have criticized the time lag between FDA market approval and CMS coverage determination. Under the TCET program, CMS did not collaborate with the FDA or medical device companies before trial design, leading to inconsistencies in generating data to support the Medicare coverage determination process, CMS executives said on a conference call.
By working together, FDA and CMS can better align evidence expectations early in the process, reducing duplication and increasing efficiency, officials said.
The new pathway program will also allow CMS to approve more medical devices for Medicare coverage by leveraging existing processes, resources and expertise through the FDA, CMS officials said on the conference call. There are currently 40 devices eligible for RAPID Pathway, and CMS leaders estimate that 20 more devices can participate. Under TCET, CMS limited the program to about five products each year, the official said.
The RAPID program will increase transparency when device manufacturers approach the FDA and CMS, Brooks said.
“We demystify the process by providing medical device manufacturers with a clear signal of exactly what goals they need to achieve in order to qualify for Medicare coverage. This is extremely valuable given the investment timelines of device manufacturers seeking to provide life-saving treatments to individuals,” he said.
The program also represents increased collaboration between FDA and CMS, as data submitted to FDA is shared with CMS in real time, Brooks said.
Medical devices approved under the RAPID pathway will receive permanent Medicare coverage, as opposed to only four years under the MCIT program, officials said.
“FDA and CMS each play a critical role in bringing new medical devices to patients, and they work best when they work together earlier in the process,” CMS Administrator Dr. Mehmet Oz said in a statement. “The RAPID application pathway will bring our two institutions together sooner, eliminate bureaucratic hassles for innovators, and give beneficiaries faster access to life-changing new medical technologies.”
