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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
evidence related to the device. Patients and their clinicians are strongly encouraged to review this information.
With access to this information, CMS
believes that patients and their clinicians are best able to consider the risks and benefits of innovative new treatments in the context of their personal health and values. Second, CMS will continue to engage with relevant stakeholdersnotably specialty societies with expert knowledge of the available treatments. CMS recognizes that these guidelines may evolve with greater experience with breakthrough devices and may assist CMS and clinicians in coverage of the devices after MCIT coverage sunsets. CMS
advises operators and institutions to consider them carefully when offering breakthrough devices covered through the MCIT pathway. Third, CMS will coordinate with the FDA to receive regular feedback on important safety signals and concerns. As a practical matter, CMS will rely on existing FDA
safety and surveillance publicly available reporting structures as an important mechanism for identifying safety concerns about covered breakthrough devices. While evidence development is voluntary, manufacturers have strong incentives to develop evidence that addresses any gaps identified through engagement with CMS at the onset of MCIT
coverage. If these gaps are insufficiently addressed during the MCIT coverage pathway, manufacturers may risk not meeting the reasonable and necessary evidentiary threshold when MCIT
coverage sunsets. Where manufacturers voluntarily pursue evidence development through robust clinical registries, those data may also provide detailed and timely data on safety of breakthrough devices under real-world conditions. Lastly consistent with some suggestions from commenters, we revised the rule to specify that coverage of a breakthrough device through MCIT
can end if the FDA removes market authorization of a breakthrough device or at the discretion of the Secretary, subsequent to an FDA medical device safety communication or Warning Letter about the breakthrough device.
Comment: Nearly a fifth of the comments received on the proposed rule were from individuals who urged Medicare to cover artificial kidney technology. The majority of these comments were from people who are affected by or care for someone affected by a form of kidney disease and/or End Stage Renal Disease. While some specifically mentioned MCIT, most did not.

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Response: CMS appreciates every comment and thanks commenters for sharing their personal stories and how their lives or the life of someone they care for could be improved by coverage of artificial kidney technology when it becomes broadly available.
Comment: A large number of comments addressed the issue of how CMS should establish durable coverage after MCIT coverage sunsets. Several commenters acknowledged that CMS
has limited resources and cannot open an NCD for all MCIT devices without securing more resources in the Coverage and Analysis Group. One commenter warned that an excessive emphasis on coverage review for MCIT devices could delay consideration of important nonbreakthrough NCD requests. Several commenters recommended that CMS be more transparent about the existing NCD wait list, the expected timing of any new NCDs, and the prioritization criteria for NCDs. They argued that manufacturers will need this information when considering which pathway is best after MCIT. The largest proportion of commenters stated that there should not be any automatic opening of an NCD, including if there is no LCD by 6 months after the end of MCIT coverage. Many commenters believe that manufacturers should instead have flexibility in choosing a coverage pathway. A smaller number of commenters recommended automatic opening of an NCD with sufficient time for seamless coverage after MCIT
coverage sunsets. Several of these commented that because the MCIT
pathway establishes national coverage that an NCD is the appropriate coverage pathway after MCIT coverage sunsets. A
small number of commenters argued that coverage for devices in the MCIT
pathway should continue indefinitely to the FDA label absent an LCD or NCD
that specifically constrains coverage.
Response: As previously noted, devices approved through the FDA
breakthrough device program may have greater uncertainty about the risks and benefits of treatment than nonbreakthrough devices, and they generally lack data on long-term safety and effectiveness at the time of FDA
market authorization. By contrast, CMS
heavily considers demonstration of improved health outcomes in making positive coverage determinations. All of the conventional coverage pathways will be available for MCIT devices after the pathway sunsets, and our regulatory reasonable and necessary coverage standard will apply. Manufacturers and stakeholders must be aware of the important distinctions between FDA
and CMS review criteria and use the
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time during the MCIT coverage pathway to close any evidence gaps that may be identified at the time of FDA market authorization.
Based on the comments, we are aware not every manufacturer wishes to pursue the NCD coverage pathway. CMS
already publishes an NCD Wait List available here: https www.cms.gov/
Medicare/Coverage/
DeterminationProcess which is updated every month as need be and we are aware of stakeholder interest in guidance on how CMS will prioritize formal and complete NCD requests.
Additionally, CMS intends to stay abreast of clinical evidence development for breakthrough devices in the MCIT pathway, and focus on whether there is new evidence in the published, peer-reviewed literature that addresses gaps identified at the time of FDA market authorization, especially whether there is compelling evidence that the device improves patient health outcomes. To allow greater stakeholder flexibility and efficient use of CMS
resources, CMS will not automatically open a National Coverage Determination NCD as a part of the MCIT coverage pathway. As previously noted, the full range of coverage options at the end of the MCIT pathway includes opening an NCD or and claim submission to a MAC.
MACs may either open Local Coverage Determinations LCDs or cover the breakthrough device on a claim-byclaim basis after MCIT coverage sunsets.
After consideration of the public comments we received, we are finalizing the proposed rule and adding modifications consistent with the safety concerns raised by commenters. We updated the text to allow for coverage to end prior to 4 years at the discretion of the Secretary subsequent to an FDA
medical device safety communication or Warning Letter. Additionally coverage will end if the FDA removes authorization of a device.
Final Action In summary, the MCIT pathway will be voluntary for manufacturers on an opt-in basis, and would provide immediate or near immediate national coverage depending upon the manufacturers chosen start date. MCIT
coverage expires four years after the date of FDA approval, irrespective of when the manufacturer requested activation of their MCIT coverage, at which point, the manufacturer may request CMS to undertake an NCD for the breakthrough device. We sought public comment on all of our proposals, and have included summaries of the comments received and the responses to those comments in this document.

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