Groups pressure CMS to speed coverage of breakthrough devices after FDA authorization

AdvaMed and dozens of other stakeholders have written to the Centers for Medicare and Medicaid Services (CMS) to reconsider implementing a reimbursement process for breakthrough devices and diagnostics akin to the previously proposed Medicare Coverage of Innovative Technology (MCIT) pathway.

The letter comes as the number of medical devices granted breakthrough designation by the US Food and Drug Administration (FDA) continues to grow. As of 30 June 2025, the agency had granted 1,176 designations and authorized 160 breakthrough devices.

The groups argue that the Transitional Coverage for Emerging Technologies (TCET) pathway, which was implemented as a compromise to MCIT, has been too restrictive for patients, manufacturers and CMS.

“We, the undersigned organizations, urge the Centers for Medicare & Medicaid Services (CMS) to create a timely, streamlined pathway for Medicare patients to access breakthrough medical technology,” said AdvaMed and 66 other stakeholders in their letter to CMS Administrator Mehmet Oz. “Closely aligning the efforts of the [FDA] and CMS, the rule will streamline regulatory coordination and eliminate unnecessary obstacles standing between physicians and patients, helping to make Americans healthier.”

“A program mirroring the core tenets of the original Medicare Coverage of Innovative Technology (MCIT) framework, embodied in legislative proposals like S. 1717 [Ensuring Patient Access to Critical Breakthrough Products Act], offers a superior solution,” they added. “This would provide coverage for FDA market authorized breakthrough technologies – including diagnostics – ensuring that Medicare patients and their care teams have more timely access to innovations upon FDA clearance.”

CMS was on track to implement MCIT at the end of the previous Trump administration. Under MCIT, Medicare coverage would have automatically been granted for products that FDA approved as breakthrough devices. Those products would then be allowed on the market for up to four years while the manufacturer gathered additional clinical data to prove their efficacy.

As the Biden administration came to office, the MCIT rule was revoked due to concerns that CMS would be relegating its authority to evaluate the effectiveness of products, and taxpayers would be on the hook to pay for products that may not prove worth reimbursing. Instead, CMS implemented a much lighter version of MCIT called TCET. It allows the agency to accept up to five breakthrough products annually and uses CMS' national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage for breakthrough devices.

According to AdvaMed and other stakeholders, programs such as TCET, “fall short of providing the consistent, timely, and predictable access that breakthrough technologies demand. Its voluntary nature and limited scope – among other issues – fall short of delivering the life-changing innovations to patients who need them most.” They argue that the Ensuring Patient Access to Critical Breakthrough Products Act proposed by Sen. Todd Young (R-IN), which attempts to revive MCIT, would be better for manufacturers and patients while providing “a clear, predictable roadmap for CMS to collect additional necessary evidence for making a permanent coverage decision.”

AdvaMed letter, FDA breakthrough data

Groups pressure CMS to speed coverage of breakthrough devices after FDA authorization

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