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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations suggestions. Some commenters offering general support of the MCIT program stated that the MCIT program should be limited, as we proposed, to technologies that are designated by the FDA as breakthrough devices. Some of these commenters supported their position by suggesting that device coverage lags further behind that of drugs and biologics and; therefore, devices are more in need of a program like MCIT.
There were specific requests for CMS to include humanitarian use devices.
Other commenters suggested that innovative devices using FDA
Investigational Device Exemption IDE
Category B designation should be eligible for MCIT.
Response: We appreciate that commenters shared their interest in CMS providing a pathway for nonbreakthrough designated devices, and we share their interest in furthering innovation. Noting that, as stated in our proposed rule, E.O. 13890 makes explicit mention of medical devices in its directive, we have heard concerns from stakeholders that there is more uncertainty surrounding coverage of devices than for other items and services, such as drugs and biologics.
For this reason, our proposal centered on breakthrough designated devices, since we believed that this was the area with the most immediate need, particularly in light of the unique FDA
criteria for breakthrough designation status. We agree with commenters that we should undertake efforts to promote innovation across all items and services which could potentially be covered under Medicare. However, because we have consistently heard from stakeholders about the need for more rapid approval of breakthrough devices in particular, E.O. 13890 explicitly mentions devices, and because the immediate opportunity is to align with the FDAs breakthrough device designation, we are not expanding beyond breakthrough devices for the final rule. As the MCIT pathway develops and proves successful, we may consider expanding its application to other items and services, including Category B IDE and HUD devices in future rulemaking.
Comment: Some commenters asserted that FDA market authorization of breakthrough devices should suffice to establish that they are safe and effective.
Other commenters argued further that establishment of safety and effectiveness is within the exclusive purview of the FDA, and no additional evidence should be required to meet the CMS reasonable and necessary evidence standard.
Response: We agree that establishment of safety and effectiveness
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is generally within the purview of the FDA under its statute, but not all items and services that may be covered under Medicare are regulated by the FDA.
Comment: A significant number of commenters noted that some breakthrough devices have no clinical data at the time of FDA market authorization, and many breakthrough devices lack data on patients older than 65, patients with disabilities, and patients with end stage renal disease, which poses some uncertainty about the FDAs ability to gauge safety and efficacy in the context of the Medicare population. There was also concern expressed about how the Medicare population is often excluded from clinical trials due to age and health status. Numerous commenters noted that the FDA frequently extends market authorization after reviewing short-term clinical studies with the proviso that ongoing data collection in the postmarket authorization period is required to establish long-term durability of treatment effect. Furthermore, commenters cited evidence that FDA
mandated post-market studies are not reliably completed and asserted that explicit assessment of safety and effectiveness in Medicare beneficiaries is essential. Several commenters provided specific examples of FDA
market authorized devices that failed to demonstrate benefit when subjected to post-market clinical study.
Response: FDA assessments of safety and efficacy are general characterizations of a product. It is always up to an individual, in consultation with their physician, to determine whether an item or service is best applied to their individual health circumstances. Given this fact, we believe that current FDA requirements for demonstrating safety and efficacy are sufficient in determining whether to grant coverage to a breakthrough device under MCIT. We also note that our rule provides for the termination of MCIT
coverage in instances 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 believe that these provisions will help protect beneficiary safety while ensuring that beneficiaries have more rapid access to new and innovative technology.
Additionally, in our proposed rule, we recognized that breakthrough devices are those that HHS has determined may provide better health outcomes for patients facing lifethreatening or irreversibly debilitating human disease or conditions. We believe that a device meeting these criteria, once also FDA market
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authorized, is reasonable and necessary for purposes of Medicare coverage. The MCIT pathway establishes rapid coverage of breakthrough devices because existing coverage pathways do not provide immediate, national Medicare coverage.
We believe this policy will provide a balance of ensuring rapid adoption of breakthrough devices, which by definition provide more effective treatment or diagnosis for life threatening or debilitating conditions, while benefitting beneficiaries. We do not agree that automatic coverage for other FDA approved products under section 1862a1A is warranted because by definition, breakthrough devices are those for which no approved alternative exists or that offer significant advantages over existing approved or cleared alternatives 21 U.S.C. 360e 3b2. Because other alternatives exist for conditions that can be treated with non-breakthrough devices, the urgency to provide coverage for these items and services on a provisional basis is not as great. In addition, we believe other avenues exist for non MICT eligible items and services to expeditiously gain coverage. For example, FDA has special procedures in place to grant fast track designation for certain new drugs, and other types of new drugs are eligible for a separate breakthrough therapy designation not to be confused with the breakthrough device designation for which this rule makes MCIT coverage available. Furthermore, the need for certainty in this regard is not as high as compared to breakthrough devices because, the FDA only grants breakthrough designation to devices where no approved or cleared alternatives exist and device availability is in the best interests of patients.
D. MCIT Pathway We proposed that the MCIT pathway would provide immediate national coverage for breakthrough devices beginning on the date of FDA market authorization and continue for up to 4
years, unless we determine the device does not have a Medicare benefit category as determined by us as part of the MCIT pathway process. The MCIT
pathway is voluntary that is, manufacturers would affirmatively optin, and would be initiated when a manufacturer notifies CMS of its intention to utilize the MCIT pathway.
This notification process is described further in section III. of this final rule.
We would subsequently coordinate with the manufacturer regarding steps that need to be taken for MCIT
implementation purposes. The frequency of subsequent engagement
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