CMS rescinds Trump-era rule expediting Medicare coverage of breakthrough devices

The Biden administration has repealed its predecessor’s last-minute rule granting expedited Medicare coverage of breakthrough devices.

The Centers for Medicare & Medicaid Services (CMS) had finalized the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule Jan. 14, just days before President Joe Biden was sworn into office.

If implemented, the rule would provide devices that received the Food and Drug Administration’s breakthrough-device designation up to four years of Medicare coverage once the product received or cleared the agency’s market authorization. CMS said at the time that its goal was to remove the gap between regulatory authorization and Medicare coverage determination, which in some cases could take up to a year.

Biden’s CMS swiftly delayed the pathway’s initial implementation date from March to December and then went a step further in September by proposing to rescind the MCIT/R&N rule altogether.

The agency said it was concerned the clinical data necessary for the FDA’s green light may not apply to the Medicare demographic’s complex conditions or care needs.

“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” CMS Administrator Chiquita Brooks-LaSure said in a statement Friday. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”

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CMS wrote in its announcement it still plans to explore coverage process improvements that achieve a similar aim but with "appropriate health and safety protections in place for the Medicare population."

To hash out that process, the agency said it will be working with the FDA, the Agency for Healthcare Research and Quality, device manufacturers and other stakeholders and will be holding "at least two" public meetings during 2022 focused on this area.

CMS also noted that other pathways are still in place to allow coverage of specific medical devices or services, such as claim-by-claim determinations.

"CMS is committed to coverage that provides an appropriate balance of support for innovation with necessary protections for Medicare patients," Lee Fleisher, M.D., CMS chief medical officer and director for the Center for Clinical Standards and Quality, said in a statement. "Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions."

The repeal is a win for the insurance industry, which had warned the faster timetable could lead to premature coverage of unproven devices. Medical device manufacturers, on the other hand, generally saw the pathway as an incentive to take more risks in their pursuit of innovative technologies.