Tech & Innovation in Healthcare

Hint: CMS suggests more research is necessary to protect patients.

In a new proposal, Medicare aims to roll back a final rule on coverage for groundbreaking technology.

Then: The Centers for Medicare & Medicaid Services (CMS) published the ‘‘Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” final rule on Jan. 14, 2021, in the Federal Register with an implementation date of March 15, 2021. This finalized rulemaking aimed to cut “delays and uncertainty in Medicare coverage” for U.S. Food and Drug Administration (FDA)-designated breakthrough devices. Under the final rule, the feds offered four years of expedited Medicare coverage as soon as the FDA authorized the devices for the market.

However, there were issues with the MCIT rule, according to CMS. These problems caused the agency to extend the rule rollout several times, finally issuing a proposal to repeal it on Sept. 15.

Now: In a March interim final rule, commenters voiced their concerns about the lack of research data on breakthrough devices in the clinical trials, particularly “on patients older than 65, patients with disabilities, and patients with end stage renal disease (ESRD),” the proposed rule says.

“They asserted that the absence of this clinical information poses some uncertainty about whether FDA’s determination of safety and efficacy could be generalized to the Medicare population,” the rule mentions.

CMS now indicates that the original MCIT final rule is “not in the best interest of Medicare beneficiaries because the rule may provide coverage without adequate evidence” on the devices, the proposed rule says. Plus, without the proper research to ensure the devices are “reasonable and necessary,” they may not work properly to treat Medicare patients for the specific diseases as intended, the agency says in the rule.

CMS wants to redefine “reasonable and necessary” and address stakeholder input, according to the proposals. If finalized, the new rule will be effective on Dec. 15, 2021.

Find the rule in the Federal Register at www.govinfo.gov/content/pkg/FR-2021-09-15/pdf/2021-20016.pdf.