Proposed to repeal the CMS Medicare coverage path for breakthrough devices designated by the FDA


On September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS” or “the Agency”) released a proposed rule, which (if finalized) would repeal the Innovative Technology Health Insurance Coverage and Definition of “Reasonable and Necessary””(“ MCIT / R & N ”) final rule. Originally released by CMS in the last week of the Trump administration, the MCIT / R&N Final Rule addressed concerns that delays and uncertainty in Medicare coverage were slowing innovation and hampering access. important new technologies of medical devices.[i] The final rule created a path to provide beneficiaries with nationwide Medicare coverage for medical devices designated as “breakthrough devices” by the United States Food and Drug Administration (“FDA”).[ii]

Under the January 2021 Final Rule, Medicare coverage for breakthrough devices would be for four years, from the date of FDA approval or a date chosen by the FDA. the manufacturer within two years of authorization. Upon conclusion of any MCIT coverage, existing coverage avenues would be available (ie, claim-to-claim arbitration, local coverage determinations (“LCD”), national coverage determinations (“MNT”). The Biden administration has twice delayed the effective date of the MCIT / R&N final rule, which was most recently due to come into effect on December 15 of this year.

Changing course, CMS now proposes to repeal the final MCIT / R & N rule. The agency says the MCIT / R&N final rule is not in the “best interests” of Medicare beneficiaries.[iii] In explaining its new position, CMS says the rule “may provide coverage without adequate evidence that the revolutionary device would be reasonable and necessary treatment for Medicare patients who are suffering from the particular disease or condition that the device is intended for. to be treated or diagnosed. “[iv] Above all, the Agency announces that CMS “no longer agrees[s] that the FDA’s safety and efficacy standards alone are sufficient to support indefinite Medicare coverage. The FDA and CMS operate under different statutes which have different purposes and the standard of coverage… is not synonymous with standards of safety and efficacy for marketing authorization for the general population.[v]

Specifically, CMS states that there is no FDA requirement that Medicare beneficiaries be included in clinical studies necessary for market authorization. As such, the agency reports that Medicare would potentially cover a medical device, despite the lack of data demonstrating that the product is reasonable and necessary for Medicare patients. CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality (“CCSQ”), Dr. Lee Fleisher, writes in an associated blog post on the Agency’s website that this clinical data is “important because Medicare patients have different clinical profiles and considerations due to the complexity of their medical conditions and concomitant treatments, compared to other groups.[vi]

Additionally, CMS is concerned about the lack of discretion to deny certain claims regarding revolutionary devices. Under previous policies, the Medicare program could deny coverage if the Agency learned that a particular medical device could be harmful to Medicare beneficiaries. Here, CMS claims that the Agency would be able to quickly remove a revolutionary device from the MCIT route of coverage only for limited reasons (e.g. FDA issues safety communication or warning letter; FDA revokes the marketing authorization for the product). The agency says such a limitation can result in preventable harm to Medicare beneficiaries.

However, the public is concerned that the repeal of the MCIT / R&N Final Rule will negatively impact the innovative nature of the medical device industry as well as the ability of beneficiaries to gain early coverage for breakthrough devices. CMS initially promulgated the MCIT / R&N Final Rule, in part, “because of concerns that delays and uncertainty in Medicare coverage are slowing innovation and hampering beneficiaries’ access to important new technologies, especially those designated as [B]drill [D]by the FDA.[vii] In the associated blog post, Dr Fleisher writes that CMS “recognizes[s] the claim-to-claim process can create a risk of non-coverage for providers and patients, as well as potential regional lags and variations in local determination.[viii] Despite these problems, CMS believes that it would be more beneficial to “pursue additional policy avenues” rather than allowing the final MCIT / R & N rule to take effect.[ix] The Agency claims that repealing the MCIT / R & N Final Rule would not prohibit coverage of revolutionary devices and that “[m]any of the eligible Revolutionary Devices are covered and payable through the existing mechanisms. “[x]

An expedited 30-day public comment period on the Agency’s proposed rule ends on October 15, 2021. In particular, the Agency is seeking comments on how CMS “can create new avenues of coverage or use existing ones. to provide an appropriate balance of access to new technologies with the necessary patient protections.[xi]

[i] Innovative Technology Medicare (MCIT) Coverage and Definition of “Reasonable and Necessary”, 86 Fed. Reg. 2987 (January 14, 2021).

[ii] Section 515B (b) of the Federal Food, Drug and Cosmetic Act (“FDCA”) defines the criteria for designating a “revolutionary device”. Eligible medical devices must meet a first criterion: the device allows a more effective treatment or diagnosis of potentially fatal or irreversibly debilitating human diseases or conditions. Eligible medical devices must also meet at least one of four parts of a second criterion: (1) the device represents “advanced technology”; (2) no approved or authorized alternative exists; (3) the device offers significant advantages over existing approved or licensed alternatives, including the potential, over existing approved alternatives, to reduce or eliminate the need for hospitalization, improve the quality of life of patients patients, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or (4) availability of the device is in the “best interest of the patient”. The FDA’s final December 2018 guidance document for the Breakthrough Devices program is available here.

[iii] Innovative Technology Medicare (MCIT) Coverage and Definition of “Reasonable and Necessary,” 86 Fed. Reg. 51326, 51327 (proposed September 15, 2021).

[iv] Identifier.

[v] Username. at 51328.

[vi] Dr Lee A. Fleisher, Innovative Technology Health Insurance Coverage (MCIT), (September 13, 2021),

[vii] 86 Fed. Reg. at 51327.

[viii] Fleisher, Innovative Technology Health Insurance Coverage (MCIT).

[ix] Identifier.

[x] 86 Fed. Reg. at 51330.

[xi] Fleisher, Innovative Technology Health Insurance Coverage (MCIT). CMS is also asking for some comments regarding the “reasonable and necessary” aspect of the proposed rule. For example, the Agency asks the following two questions: “Instead of repealing the R&N rule entirely, should the final rule instead simply repeal the commercial insurance aspects of the rule?” If CMS is considering the future development of rules to include a reasonable and necessary definition, what criteria should CMS consider as part of the reasonable and necessary definition? »86 Fed. Reg. at 51331.

Copyright © 2021 Nelson Mullins Riley & Scarborough LLPRevue nationale de droit, volume XI, number 264

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