The US Centers for Medicare & Medicaid Services (CMS) and the US Food and Drug Administration (FDA) have introduced a new coverage pathway designed to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for individuals on Medicare.
The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway has been developed so the FDA and CMS can work with medical device companies earlier in the technologies’ development lifecycle, with the intention that evidence generated for FDA review will also support Medicare coverage decisions.
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According to the US health agencies, by aligning regulatory and coverage expectations in advance, the RAPID pathway will “significantly reduce” historic delays between FDA market approval and Medicare national coverage determinations.
The agencies intend to publish a procedural notice outlining the RAPID pathway’s structure in the Federal Register. The public will have 60 days to provide comments on the notice, to which the CMS said it will respond in the form of a final notice, from which time the pathway is anticipated to come into effect.
CMS administrator, Dr Mehmet Oz, commented: “The 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.
“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.”
Health agencies under the Trump administration: a need for speed
Since President Trump returned to the White House in January 2025, a range of new initiatives have been introduced by the health agencies nested under the US Department of Health and Human Services (HHS), all with an apparent bias towards speed.
In June 2025, the FDA introduced a generative artificial intelligence (genAI) tool named Elsa that seeks to streamline efficiencies throughout the regulatory evaluation of medical devices and pharmaceuticals. However, some observers have noted that issues remain with the AI, and suggest the technology is not an adequate replacement to the deep staffing cuts HHS head Robert F Kennedy Jr (RFK Jr) made to the US health agencies early into his tenure.
The CMS is also applying AI to modernise how Medicare approves certain procedures before they are performed in an approval process called prior authorisation. Expert observers warn that for such an initiative to succeed in a safe and fair manner, a ‘human in the loop’ will be key.
Other initiatives geared towards driving efficiencies and the speed at which it takes things to get done across the US health agencies, including the CMS’s data sharing initiative and Tempo, a pilot that seeks to take a risk-based enforcement approach to assess how patient access to digital health devices can be made more efficient.
All these initiatives appear to have cost savings at the forefront, resonating with broader actions taken by the Trump administration. Beyond RFK Jr’s staffing cuts at the health agencies, regarding healthcare, Trump’s ‘Big Beautiful Bill (BBB)’, which sought to ravage funding for the likes of Affordable Care Act (ACA) subsidies, led to the biggest US government shutdown in history in October 2025.
The BBB eventually passed and the shutdown impasse was resolved after Democrat party leader Chuck Schumer capitulated.
