CMS Publishes Proposed Rule to Repeal Coverage of FDA-Designated “Breakthrough Devices”

September 15, 2021—The Centers for Medicare & Medicaid Services (CMS) published a proposed rule in the Federal Register that would repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” (R&N) final rule, which was published on January 14, 2021. On March 17, CMS published notice of an interim final rule that delayed the effective date of the final rule (originally May 14) and opened a 30-day public comment period. On May 18, CMS published the final rule delaying the effective date of the final rule till December 15.

According to CMS, a new public comment period allows interested parties to provide comments about the proposed repeal, the agency’s intent to conduct future rulemaking to explore an expedited coverage pathway that provides access to innovative beneficial technologies, and the reasonable and necessary definition. Comments must be received within 30 days of the September 15 date of publication in the Federal Register. All information for submitting comments is available in the Federal Register publication.

According to CMS, the MCIT/R&N final rule established a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to recently market-authorized medical devices designated as breakthrough by the FDA. Under this final rule, MCIT would result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. The MCIT/R&N final rule would also implement regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act for items and services that are furnished under Medicare Parts A and B.

Now, CMS proposes to repeal the MCIT/R&N final rule. The agency’s rationale for this proposed rule and its request for comments on the proposed rule are explained in the Federal Register.

CMS stated in the Federal Register that reasons for repealing the final rule include, in brief, the following:

• The finalized MCIT/R&N rule is not in the best interest of Medicare beneficiaries because the rule may provide coverage without adequate evidence that the Breakthrough Device would be a reasonable and necessary treatment for the Medicare patients that have the particular disease or condition that the device is intended to treat or diagnose
• Although the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with respect to use in the Medicare population upon receipt of coverage
• Based on the comments received throughout the development of the MCIT pathway, CMS does not believe that the final rule as currently drafted, is the best way to achieve the goals of MCIT as outlined in the MCIT/R&N final rule to more precisely meet the needs Medicare beneficiaries and other stakeholders in a timely fashion; CMS stated other ways to achieve the stated goals may include better utilizing existing pathways or conducting future rulemaking