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CMS Proposed Rule Repeals MCIT Final Rule

September 17, 2021

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DATA CONTACTS
Ivy Baer, Senior Director and Regulatory Counsel

On Sept. 15, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule withdrawing  a rule finalized during the final days of the Trump administration, Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary.” The agency provided an opportunity for interested parties to comment on the proposed repeal and also provide ideas about providing Medicare beneficiaries with expedited coverage. Comments are due Oct. 15.

The rule would have allowed Medicare coverage of devices for four years once the device received Food and Drug Administration (FDA) market authorization. Once the devices were covered, the rule did not require manufacturers to develop additional scientific evidence to support the use of these devices for the Medicare population. Coverage of these devices is already available by local coverage determinations and national coverage determinations, which also includes coverage with evidence development. There is no requirement under the FDA approval process that Medicare beneficiaries be included in clinical trials.

The CMS is also asking for comment on whether the definition of “reasonable and necessary,” a requirement for Medicare coverage, should be expanded to consider commercial insurance coverage as a factor. At the time the final rule was finalized, the CMS said it would issue subregulatory guidance regarding consideration of commercial insurer coverage policies. The CMS is asking respondents whether it should repeal the commercial insurance aspect of the rule and leave the rest unchanged.

The AAMC opposed the MCIT rule and will be submitting comments on the proposed repeal [refer to Washington Highlights, Nov, 2, 2020].

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