The Centers for Medicare and Medicaid Services and the Food and Drug Administration have unveiled a new pathway to speed up Medicare coverage for certain breakthrough medical devices.
The pathway, called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, allows the two health agencies to work together, and with companies, during the device review process to speed up Medicare coverage for certain FDA-designated Class II and Class III breakthrough medical devices.
The approach could enable Medicare national coverage and payment as soon as two months after a device has received market authorization, compared with approximately one year or more under the current system, according to the Thursday announcement.
“The American people deserve timely access to meaningful treatments without red tape or high costs,” FDA Commissioner Marty Makary said in a press release. “In this administration, FDA and CMS are functioning as a single team to deliver life-saving Breakthrough Devices to American patients as soon as we know they work.”
AdvaMed, a prominent medical device lobby group, called the RAPID pathway a “positive step” toward ensuring Medicare patients have access to breakthrough technologies.
“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,” CEO Scott Whitaker said in an emailed statement to MedTech Dive.
The FDA created the breakthrough device program to speed up the review and market authorization process for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating health conditions. The program provides device makers with earlier access to FDA officials and prioritized review.
While the program is meant to bring new technologies to the market more quickly, there have been concerns in the medical device industry for years about the time it takes for those products to then get Medicare coverage. It takes an average of five years after a device is authorized by the FDA to gain national Medicare and commercial insurance coverage, according to a survey from the Stanford Byers Center for Biodesign and the Duke-Margolis Center for Health Policy.
To help speed up coverage, the CMS created the Transitional Coverage for Emerging Technologies pathway in 2024. The pathway considers five new breakthrough technologies a year for Medicare coverage, a small number of the more than 100 devices that are typically granted breakthrough status every year.
AdvaMed criticized the TCET pathway when it was finalized for the limited number of devices that can participate.
About 40 devices would currently qualify for the new RAPID pathway right now, a senior CMS official said during a Thursday press call, with an additional about 20 that could potentially qualify.
The RAPID pathway would allow the CMS and FDA to work together and with innovators earlier in the development process. The evidence generated for the FDA’s review of a medical device could also be used to help support Medicare coverage decisions. The pathway will connect device manufacturers with CMS experts early in the development process to understand what clinical outcomes are most relevant for Medicare beneficiaries.
The agencies will work with device manufacturers as they design their pivotal trials with the FDA, allowing the companies to design studies that would collect specific evidence that is required for Medicare coverage, a senior CMS official said on the call. The official added that previously some companies would not generate the correct evidence for Medicare coverage and would have to design new trials.
To qualify, products must be breakthrough devices that address an unmet clinical need for Medicare beneficiaries. The pathway is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program, or TAP, and Class III devices regardless of whether they participate in TAP. Devices must also be the subject of an investigational device exemption study that enrolls Medicare beneficiaries and studies clinical health outcomes agreed upon by the FDA and CMS.
Under the pathway, the CMS will issue a proposed national coverage determination the same day an eligible device receives FDA marketing authorization. The move will trigger the required 30-day public comment period for the NCD.
CMS Administrator Dr. Mehmet Oz, who advocated for speedier access to Medicare coverage for certain devices during his confirmation hearing last year, said in the announcement that the pathway “brings our two agencies together earlier, cutting red tape for innovators, and helping beneficiaries access new, life-changing health technology faster.”
The TCET pathway will be paused for new candidates as the CMS focuses on RAPID, according to the announcement.
A proposed procedural notice outlining the RAPID pathway will be published in the Federal Register, opening up a 60-day public comment period. The CMS will respond to public comments in its final notice.
