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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations development programs in line with their goals and business needs.
A larger number of commenters supported mandatory evidence development. One commenter did not support the MCIT pathway, but if implemented, argued that mandatory evidence development mitigates the risks of this regulation. A number of commenters stated that early coverage tied to mandatory evidence development strikes an economically appropriate balance. Some commenters noted that post-market clinical studies may more efficiently capture longerterm outcomes than within conventional clinical studies. Several commenters stated that mandatory evidence development is appropriate provided that it is efficient, streamlined, and time-limited. Several commenters noted that post-market evidence development is essential for development and refinement of clinical practice guidelines that inform evidence-based clinical practice. Other commenters noted that mandatory data collection is necessary to assure appropriate use of technologies, and that use without oversight could be economically disastrous. Furthermore, they stated that low-value practice patterns may be very difficult to reverse once they are established.
Response: CMS is not mandating evidence development during MCIT
coverage. After coverage through the MCIT pathway ends, all existing coverage pathways will remain available to manufacturers to establish durable coverage. CMS will require breakthrough devices to meet the longestablished reasonable and necessary coverage standard, just as they would without the MCIT pathway. CMS
anticipates that most manufacturers will voluntarily pursue robust evidence development to secure durable coverage after MCIT coverage sunsets.
We are aware of stakeholders interest in CMS providing detailed, specific, and actionable guidance to manufacturers on evidence deficits relative to the longestablished reasonable and necessary threshold. We are considering the feasibility of this approach. CMS notes that the expected diversity of breakthrough devices speaks to flexibility in evidence development. In some instances, manufacturers may wish to participate in conventional clinical studies; in others, a registrybased clinical study may offer the most robust and cost-efficient option.
Manufacturers may also wish to pursue studies that rely on real-world evidence, but they are strongly encouraged to review these study designs with CMS.
Manufacturers are encouraged to engage
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CMS soon after FDA market authorization with an evidence development plan that addresses any identified evidence gaps.
CMS believes that rigorous and publicly available evidence is necessary to inform beneficiaries, the clinical community, and the public about the risks and benefits of available treatment options. Published studies are also necessary for breakthrough devices to be included in evidence-based guidelines, which feature heavily in CMS
assessment of accepted standards of medical practice. Therefore, CMS
requires that stakeholders publish evidence in the peer-reviewed clinical literature and applies rigorous methodologic standards in evidence review supporting local or national coverage analyses.
Comment: As related to the ending of MCIT, a number of commenters noted safety concerns of breakthrough devices over the four years. Commenters noted the need to continue to monitor use and outcomes and to suspend MCIT if the FDA withdraws approval or there are concerns with safety in post-market data.
Response: We appreciate the comments and agree on the need to monitor harms.
These concerns are particularly relevant to the suggested 4 year duration of MCIT. We believe appropriate mechanisms should be in place to end automatic coverage in certain scenarios.
In general, safety is within the FDA
authority. However, there are appropriate commonalities when the health outcomes are higher mortality or higher numbers of strokes or heart attacks. Based on overall comments on safety, we will include a mechanism in the final rule to allow suspension or termination of MCIT when FDA has issued a warning letter, medical device safety communication, or black box warning and CMS determines that harms outweigh benefits for Medicare patients.
Comment: A series of comments cited FDA guidance that the Breakthrough Devices Program allows for greater uncertainty of risks and benefits than non-breakthrough approval processes because the breakthrough devices meet an important and unmet clinical need.
Several commenters also note that the FDA relies more heavily on post-market data collection for these devices, and often breakthrough devices lack data on long-term safety and effectiveness at the time of FDA market authorization.
Several commenters cited evidence that many FDA mandated post market studies are never completed and that the FDA safety and surveillance system is
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both flawed and insufficient to assure beneficiary safety during MCIT
coverage. One commenter noted that lax FDA safety reporting may allow continued CMS coverage despite important safety problems. One commenter suggested that CMS should mandate safety reporting to both CMS
and the FDA Manufacturer and User Facility Device Experience MAUDE
database at regular intervals as a condition of MCIT coverage. Several commenters suggested that CMS should regularly review FDA safety reports for covered breakthrough devices. Several commenters argued that any safety warnings or product recalls should terminate coverage within the MCIT
coverage pathway.
One commenter noted that Medicare beneficiaries are likely to perceive that FDA market-authorized and CMScovered items or services have been established as safe and effective.
Another commenter suggested that Medicare beneficiaries will be unwitting clinical trial subjects if they are treated with a breakthrough device through the MCIT coverage pathway. Several commenters stated that the proposed MCIT regulation lacks any mechanism for stakeholder input, especially specialty societies, into operator and institutional requirements that protect beneficiary safety prior to national coverage. A large number of commenters noted that absent mandatory evidence development, the MCIT regulation lacks a mechanism to assure safety, outcomes, and quality of care for covered breakthrough devices.
Several commenters suggested that CMS
should monitor safety events using registries, FDA safety reports, and claims data monitoring.
Response: The Administration is committed to encouraging medical innovation and to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes. The MCIT regulation meets this goal for FDA market-authorized breakthrough devices. However, patient safety is always a central concern, and CMS agrees that the MCIT regulation must balance early access to innovative medical devices with strong patient safety protections.
CMS has developed a number of process steps to address this important balance of access and safety. First, the Administration has championed transparency as a critical mechanism for beneficiary empowerment in decisionmaking about their own healthcare.
Accordingly, devices covered through the MCIT pathway will be publicly posted on the CMS website. We aim to also indicate publicly available clinical
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