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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
In contrast to these other coverage pathways, MCIT is readily available to provide immediate national coverage for new breakthrough devices with a Medicare benefit category as early as the same date as FDA market authorization.
The MCIT pathway can support manufacturers that are interested in combining coverage with their own clinical study to augment clinical evidence of improved health outcomes, particularly for Medicare patients.
Comment: Many commenters generally supported the MCIT concept, expressing that it would result in faster and more consistent access to newly authorized technologies for Medicare beneficiaries. Those commenters recognized that immediate coverage of newly FDA market-authorized breakthrough technologies via the pathway would avoid the ambiguity and possible inconsistency of claim-byclaim coverage by the MACs as well as the delays inherent in either the LCD or NCD pathways. Commenters suggested that MCIT will bring closer alignment of FDA and CMS decision-making, and would help to more closely coordinate coverage, coding and payment functions. Those who were supportive also stated their belief that the proposal would promote innovation; decrease uncertainty and delays in coverage;
improve FDACMS coordination; and improve beneficiary access to cuttingedge treatments. Many commenters expressed support for the MCIT
proposal in principle but nonetheless requested important clarifications or expressed significant reservations about specific elements.
Some commenters did not believe that the proposed MCIT pathway was necessary because existing coverage pathways provide a sufficient mechanism for coverage of newly FDA
market authorized items and services.
One commenter expressed concern that the MCIT pathway may undermine or circumvent existing pathways. A few commenters recommended that coverage for breakthrough technologies should be left to MAC discretion because they retain considerable flexibility to cover new technologies and can adjust coverage policy as new evidence emerges. Other commenters discussed the parallel review and Coverage with Evidence Development CED programs CED is a paradigm whereby CMS issues an NCD to cover items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data.
The commenters stated that the parallel review program may shorten the time between FDA market authorization and
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coverage, but is generally more appropriate for items and services where there is relatively greater clinical evidence than under the breakthrough device pathway. For topics where there is less evidence on safety and efficacy available, such as newly FDA market authorized breakthrough technologies, they asserted the CED pathway is more appropriate. A few commenters recommended that instead of establishing the MCIT pathway, more resources should be applied to existing pathways to allow CMS to conduct expeditious review of a larger number of topics.
Response: CMS agrees that coverage of breakthrough devices through the MCIT pathway will accelerate access to items and services that address important unmet needs, as well as help CMS work more closely with FDA. We do not believe that simply devoting more resources to the existing coverage pathways will yield the synergy with FDA we anticipate will be created from the MCIT pathway. With the exception of claim-by-claim coverage, both LCDs and NCDs are subject to statutory timeframes and require considerable CMS resources to complete. This includes policy analysts, epidemiologists, physicians, data analysts and additional supporting staff in addition to contract money that is required to host meetings of the Medicare Evidence Development and Coverage Advisory Committee and commission external technical assessments. There are many steps outlined in Chapter 13 of the PIM
regarding the process for attaining an LCD, and this process must be repeated in each MAC jurisdiction. The MCIT
pathway will increase Medicare beneficiary access to newly FDA
market-authorized treatments, for which similar devices may not exist and which improve health outcomes for patients, simplify and accelerate the process to gain coverage, and eliminate geographic variations in coverage that may occur for treatments covered on a claim-byclaim basis. Support for further innovation is a secondary benefit of the MCIT coverage pathway. We also agree with commenters that the parallel review program or CED may not be available to innovators under all circumstances, or may not be the most appropriate pathway for their circumstances, which is in part why we are making the MCIT pathway available as another route to CMS coverage. We remind commenters that coverage under MCIT is provisional, and that once MCIT coverage expires, our standard definition of reasonable and necessary
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as modified in this rulemaking, will be applied to determine whether and when to cover these devices.
We do not agree that the MCIT
pathway will undermine or circumvent existing pathways. Only breakthrough devices will be eligible for the MCIT
pathway. Sec. 515Bc of the Federal Food, Drug, and Cosmetic Act FD&C
Act 21 U.S.C. 360e3c states that a request for a breakthrough device designation may be made at any time prior to the submission of an application for premarket approval, approval under Sec. 510k of the FD&C
Act 21 U.S.C. 360k, or approval under a de novo marketing authorization. Because requesting a breakthrough device designation presumes an application for approval under one of these three pathways, the MCIT pathway depends on, and does not undermine, these three avenues for FDA approval. We also do not agree that coverage for breakthrough technologies should be left to MAC discretion. The MCIT pathway will provide innovators greater certainty of initial Medicare coverage.
Comment: We solicited comments in the MCIT proposed rule on whether the MCIT pathway should also include diagnostics, drugs and/or biologics that utilize breakthrough or expedited approaches at the FDA for example, Breakthrough Therapy, Fast Track, Priority Review, Accelerated Approval or all diagnostics, drugs, and/or biologics. Some commenters expressed support for changing the way innovative technologies without FDA breakthrough device designation are covered by Medicare. These commenters pointed out that there may be innovative technologies which they believe ought to be covered by Medicare that choose not to use FDAs breakthrough device pathway or may be an innovative technology that may not qualify for the designation. One commenter suggested that CMS should preclude MACs from non-covering these technologies. Other commenters suggested nonbreakthrough devices, drugs, and biologics should be eligible for an MCIT
type of coverage pathway because nonbreakthrough items and services also improve patient health outcomes. One commenter recommended that CMS be able to include non-breakthrough devices based on agency discretion as to when beneficiaries should have expedited access to an item or service.
In response to the question CMS
posed about whether MCIT should include diagnostics, drugs, and biologics that use the breakthrough or other expedited FDA pathways, commenters provided varied
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