CMS, FDA propose new RAPID pathway

The Centers for Medicare & Medicaid Services and the Food and Drug Administration have opened a new route for some breakthrough medical devices while moving to close an older Medicare payment shortcut. On April 23, the agencies announced the Regulatory Alignment for Predictable and Immediate Device, or RAPID, pathway, which would bring CMS into device evidence planning earlier in development. Less than two weeks earlier, CMS published a proposed fiscal 2027 hospital payment rule that would repeal the “alternative pathway” used by some breakthrough devices to qualify for new technology add-on payments, or NTAP. Together, the steps would change how some products move from FDA review into Medicare coverage and hospital reimbursement. ### Why are CMS and FDA changing two policies at once? April 23 is the date CMS and FDA said RAPID would begin as a joint coverage pathway for certain FDA-designated Class II and Class III breakthrough devices. FDA said the program is designed to let CMS and FDA work with manufacturers earlier so clinical evidence developed for FDA review can also support Medicare coverage decisions. CMS Administrator Mehmet Oz said the agencies “work most effectively when aligned sooner in that process,” while FDA Commissioner Marty Makary said the administration wanted “timely access” without “red tape or high costs.” (fda.gov) April 14 is the date CMS published the proposed FY 2027 inpatient payment rule that includes repeal of the NTAP alternative pathway for breakthrough devices. The Federal Register summary says the proposal would require all applicants for inpatient NTAP and outpatient device pass-through payments to demonstrate they meet all eligibility requirements, including the substantial clinical improvement standard, rather than using the alternative pathway. (fda.gov) ### What exactly was the NTAP alternative pathway? CMS has long used NTAP to provide add-on payments for some new inpatient technologies that are not yet fully reflected in diagnosis-related group rates. The agency’s NTAP page says the payment is available for new medical services and technologies used in the inpatient setting and that FY 2027 comments, including NTAP applications, are due June 9. (cms.gov) The Federal Register summary says the alternative pathway had allowed certain transformative new devices to qualify for NTAP without the same showing required of other technologies on substantial clinical improvement. CMS said in the proposed rule that all applicants would instead have to demonstrate they meet the full eligibility criteria for add-on payments. (cms.gov) ### Which devices could use RAPID? FDA said RAPID is available for certain FDA-designated breakthrough devices that address unmet medical needs among Medicare beneficiaries. The April 23 announcement says the pathway covers certain Class II devices participating in FDA’s Total Product Life Cycle Advisory Program, or TAP, and Class III devices whether or not they participate in TAP. (federalregister.gov) FDA’s Breakthrough Devices Program applies to devices subject to premarket approval, 510(k) clearance or De Novo classification requests if they are intended to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The agency says the program offers prioritized interaction and review but does not change the requirement that devices meet FDA standards for safety and effectiveness before marketing authorization. (fda.gov) ### How could this affect diagnostics and device launches? Medicare coverage and payment often move on separate tracks, and the two April actions target different parts of that process. RAPID is aimed at national coverage planning after FDA authorization by aligning evidence expectations earlier, while the NTAP proposal would tighten access to temporary hospital add-on payments by restoring the substantial clinical improvement test for breakthrough devices. (fda.gov) That means a manufacturer could face a different reimbursement path in the inpatient setting even as CMS and FDA try to shorten the gap to a national coverage decision. Class II and Class III breakthrough devices can include diagnostics as well as other device categories, according to FDA’s breakthrough program description. CMS and FDA did not single out molecular diagnostics or artificial intelligence-enabled tests in the materials reviewed, but those products can fall within the device framework if they meet FDA’s device definitions and program criteria. That is an inference based on the agencies’ descriptions of eligible device classes and FDA review pathways. (fda.gov) ### What happens next, and when? June 9, 2026, is the deadline CMS set for comments on the FY 2027 IPPS proposed rule, including the NTAP policy changes. CMS’s proposed-rule page says comments must be received by 5 p.m. EDT to be assured consideration. October 1, 2026, is the date fiscal 2027 inpatient payment policies would typically take effect if finalized on the usual schedule, though CMS has not yet issued a final rule on this provision. (fda.gov) RAPID, by contrast, has already been announced by CMS and FDA, and the agencies said manufacturers of eligible devices can engage earlier with CMS experts on evidence relevant to Medicare beneficiaries. (cms.gov)