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Federal Register / Vol. 86, No. 50 / Wednesday, March 17, 2021 / Rules and Regulations
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where the device is furnished, whether there is an existing payment methodology that applies to the particular breakthrough device including, for example, whether a device would be paid under a bundled payment system or is separately payable. We must also determine whether there is an appropriate billing code for the device in order to support electronic claims filing and efficient claims processing.
We recognize that some public comments on the September 1, 2020
MCIT proposed rule, especially from manufacturers, supported our initiating MCIT only after coverage, coding, and payment had been established. We underestimated the operational challenges highlighted by these comments. We seek comment on how CMS should resolve the operational issues, such as benefit category determinations, coding, and payment levels.
2. Overlapping Rules CMS separately proposed a Benefit Category and Payment Determination process in the November 4, 2020
proposed rule titled Benefit Category and Payment Determinations for DME, Prosthetic Devices, Orthotics and Prosthetics, Therapeutic Shoes and Inserts, Surgical Dressings, or Splints, Casts, and Other Devices Used for Reductions of Fractures and Dislocations DMEPOS 85 FR 70358.
The comment period for the November 2020 proposed rule closed on January 4, 2021. This proposed rule outlined a process to establish a BCD for Durable Medical Equipment DME. The proposed rule has not been finalized.
Because of the publication sequences of the MCIT public comment period ending on November 2, 2020 and the DMEPOS proposed rule being published 2 days after the MCIT comment period closed, it may not have allowed stakeholders to adequately comment on the integration of the two policies.
While we recognize the proposed rule was specifically considering DMEPOS, and not all breakthrough devices fall within these categories, that rule may serve as a model for resolving similar operational issues that could expedite and facilitate Medicare payment. While CMS has not completed its public comment review of the DMEPOS
payment rule, there are comments requesting that CMS align its processes.
We seek comment on whether commenters would have raised additional concerns if there had been an opportunity to comment on the DMEPOS payment and MCIT rules at the same time.

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3. New Information: Breakthrough Device Volume The regulatory impact analysis RIA
published as part of the MCIT final rule was based on the expectation that the FDA breakthrough device program would initially apply to a relatively small number of devices based on the low number of breakthrough devices that had become market authorized.
Using this information, we assumed this number would remain in a relatively steady state for the first few years and included this assumption in the RIA.
The MCIT proposed rule stated that 2 to 5 devices would likely fall within the MCIT coverage pathway initially and would remain fairly consistent in the short term, and increase gradually thereafter. At that time, the publicly available FDA count of breakthrough device designations was from the end of fiscal year 2018, when there were 97
FDA-designated breakthrough devices.
New data, publicly reported by the FDA
on February16, 2021 https
www.fda.gov/news-events/fda-voices/
reflections-record-year-novel-deviceinnovation-despite-covid-19challenges, indicated that more than 400 devices have been designated as breakthrough. We recognize that not all of those devices will be marketauthorized, and we cannot know the precise timing of those market authorizations. Recent public data suggests a larger number of marketauthorized breakthrough devices may be eligible for MCIT. The public may not have had an opportunity to consider this aspect of potential growth. We seek comment on whether the assumption about the potential volume of FDA
breakthrough devices was flawed such that the public did not have a meaningful opportunity to comment on the proposed rule.
4. Medicare Patient Benefit/Protection and Other Issues Further, after the close of the MCIT
public comment period, some experts raised questions in published articles about how breakthrough technology may workin older patients and the evidence basis for Medicare coverage of these technologies Bach. New York Times, December 1, 2020; https
www.nytimes.com/2020/12/01/opinion/
trump-medicare-medicaid.html; Eroding Progress on Evidence and Outcomes:
CMSs New Proposed Pathway for Medical Device Coverage. Neumann and Chambers. Health Affairs, December 2, 2020 and Medicares New DeviceCoverage PathwayBreakthrough or Breakdown. Rathi, Johnston, Ross and Dhruva. New England Journal of
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Medicine, March 10, 2021. CMS is aware that Medicare patients often have different clinical profiles and considerations due to the complexity of their medical conditions and multiple treatments compared to other age groups. Because Medicare patients usually have more than one comorbidity and are likely being treated for more than one condition, CMS has historically reviewed clinical evidence showing that the devices have been studied in the Medicare population or that outcomes are generalizable to the Medicare population. The various treatments may interact with each other, potentially affecting overall patient benefits.
Some public commenters challenged CMS premise that the MCIT coverage could result in improved care for Medicare beneficiaries absent specific evidence that the MCIT eligible devices benefit the Medicare population. In response to the public comments, the MCIT final rule gives CMS authority to remove a breakthrough device from the MCIT pathway where a medical device safety communication or warning letter is issued by the FDA, or if the FDA
revokes market authorization for a device. We seek comment on whether the revisions in the MCIT final rule adequately addressed the publics concern of clinical benefit to the Medicare population.
5. Public Request for a More Detailed Proposal Public commenters on the proposed rule requested that we not finalize the rule because of a potential lack of clarity on the reasonable and necessary definition, which is the statutory standard for covering MCIT
breakthrough devices after the coverage pathway ends and most items and services that fall under the Medicare fee-for-service program. These commenters stated that CMS did not include sufficient detail in the proposed rule about the impact of commercial insurance coverage and, therefore, suggested that they could not adequately or meaningfully comment.
Further, some commenters suggested that the agency should publish another proposed rule with significantly more detail. We seek comment on whether the public had adequate opportunity to comment on the proposed rule. We are also soliciting comment on whether CMS adequately responded to objections to the proposed rule, including whether interested parties had fair opportunities to present contrary facts and arguments that may help to improve the final rule.

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