Dive Brief:
- The Centers for Medicare and Medicaid Services is asking for public comment on a plan that would significantly shorten the timeframe between Food and Drug Administration authorization and Medicare coverage for some breakthrough medical devices. Comments on the procedural notice will be accepted for 60 days.
- It can take nearly five years on average for a medical device to get national Medicare and commercial insurance coverage after receiving FDA authorization, according to a survey by the Stanford Byers Center for Biodesign and the Duke-Margolis Institute for Health Policy.
- Under the new Regulatory Alignment for Predictable and Immediate Device coverage pathway, dubbed RAPID, a proposed national coverage determination for certain devices would be issued the same day as FDA market authorization, meaning national Medicare coverage could begin as soon as 60 days afterward, the CMS said.
Dive Insight:
The RAPID pathway proposal, first unveiled in April, is intended to help Medicare beneficiaries gain quicker access to eligible Class II breakthrough devices in the FDA’s Total Product Life Cycle Advisory Program and eligible Class III breakthrough devices regardless of TAP participation.
The FDA’s breakthrough device program was designed to prioritize market authorization reviews for devices that offer more effective treatment or diagnosis for life-threatening or debilitating medical conditions. However, the device industry has long been concerned about the length of time it takes for new technologies to gain Medicare reimbursement.
RAPID would use the FDA’s existing process for assessing clinical outcomes in proposed investigational device exemption studies to streamline Medicare coverage decisions after market authorization. The plan would connect CMS experts with device manufacturers early in the development process.
Improvement shown in study outcomes and the device’s relative risk will determine if further evidence development is needed for the NCD, the CMS said. If the agency finds coverage with evidence development is necessary, it will communicate with the FDA and manufacturer before FDA market authorization to align those needs with any post-approval studies the FDA requires.
In vitro diagnostic products will not be accepted into RAPID. CMS has historically delegated review of many laboratory tests to specialized Medicare administrative contractors, and the agency said it believes most coverage determinations for IVDs granted breakthrough designation should continue to be set by the MACs.
Devices beyond the IDE pre-submission stage also are not appropriate for RAPID, the CMS said.
