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Federal Register / Vol. 86, No. 94 / Tuesday, May 18, 2021 / Rules and Regulations
necessary. CMS reviewed fee-for-service claims data for several recent marketauthorized breakthrough devices. The majority of the FDA market authorized breakthrough devices that would have been eligible for the MCIT pathway were already paid through an existing mechanism or were predominantly directed to a pediatric population. Of those that would be separately payable by Medicare on a claim-by-claim basis, the reviewed devices, were covered and paid under the applicable Medicare payment system.
Regarding commenters concerns about automatic coverage without evidentiary support, we share commenters concerns that guaranteeing coverage for all breakthrough devices receiving market-authorization for any Medicare patient with possibly minimal or no evidence on the Medicare population and no requirement to develop evidence on the Medicare population could be problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries. For example, a breakthrough device may only be beneficial in a subset of the Medicare population or when used only by specialized clinicians to ensure benefit.
Without additional clinical evidence on the devices clinical utility for the Medicare population, it is challenging to determine appropriate coverage of these newly market-authorized devices.
Comment: Multiple stakeholders manufacturers, physicians, associations commented that CMS
should modify the MCIT policy in some way. A substantial number of comments from a variety of stakeholders expressed evidentiary concerns with MCIT as currently designed, including that the current MCIT/R&N final rules pathway establishes an open-ended coverage commitment for all breakthrough devices without demonstrating a health benefit in the Medicare population.
Additionally, commenters were concerned that the current MCIT/R&N
final rule does not specify, nor can it require, coverage criteria beyond the FDA indications for use, and that evidence development under MCIT is voluntary, and narrowing coverage after MCIT expires will be challenging for devices that do not have a documented, proven benefit for Medicare patients.
Many of these stakeholders recommend that CMS leverage or broaden the existing coverage with evidence development CED pathway to provide more timely and appropriate access to new technologies. These commenters encouraged CMS to require post market studies and data collection as part of
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MCIT to ensure that beneficiaries are gaining access to new technologies that improve health outcomes. Several breakthrough device manufacturers suggested that, for inclusion in MCIT, a portion of FDA pivotal studies should include a portion of Medicare beneficiaries. One breakthrough device manufacturer suggested that 25 percent of patients in the pivotal study should be Medicare beneficiaries for MCIT;
otherwise, CED would be more appropriate.
Response: We agree that for breakthrough devices for which studies did not include Medicare populations or populations with characteristics similar to the Medicare population CED or a similar evidence development process would strengthen the evidence base relevant to Medicare patients. In past NCDs, we have leveraged FDA required post-market studies in CED decisions.
In contrast to the NCD process which involves a robust review of available clinical evidence, especially for the Medicare population, to determine whether the item or service is reasonable and necessary for Medicare beneficiaries, the current MCIT pathway in the MCIT/R&N final rule establishes a 4-year coverage commitment for all breakthrough devices that have a benefit category without a specific requirement that the device must demonstrate a health benefit or that the benefits outweigh harms in the Medicare population. In general, Medicare patients have more comorbidities and often require additional and higher acuity clinical treatments which may impact the outcomes differently than the usual patients enrolled in early studies. Medicare has also focused on real world data or implementation studies to understand how items and services perform when more broadly used in general practice in the Medicare population. These considerations are often not addressed in the early device development process.
We also note that FDA grants breakthrough designation early in a devices product lifecycle. In part, the FDA considers whether there is a reasonable expectation that a device could provide for more effective treatment or diagnosis relative to the current standard of care SOC in the U.S. A complete set of clinical data is not required for designation. 1 At the time a device is granted breakthrough status by the FDA, little may be known 1 U.S. Department of Health and Human Services, Food and Drug Administration Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff 9 December 18, 2018, available at https www.fda.gov/media/
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about the benefits and harms of the device. We recognize the importance of breakthrough technologies that provide for more effective treatment of lifethreatening and irreversibly debilitating diseases and conditions when no effective treatment exists.
In cases where there is greater uncertainty surrounding the benefit-risk profile of a breakthrough device, some commenters have suggested that more relevant evidence is needed for Medicare patients to determine health benefit, to mitigate harms that may not be apparent in initial studies with small sample sizes, and to understand the balance of benefits and harms when breakthrough devices are used more broadly in Medicare patients. The additional delay announced in this rule will provide an opportunity to ensure that the objections to the rule are adequately considered. We will consider ways to diminish uncertainty with respect to Medicare coverage by building upon the evidence foundation established during the market authorization process or combining that evidence with other approaches like CED to expedite coverage in appropriate instances.
For CMS, the evidence base underlying the FDAs decision to approve or clear a device for particular indications for use has been crucial for determining Medicare coverage through the NCD process. CMS looks to the evidence supporting FDA market authorization and the device indications for use for evidence generalizable to the Medicare population, data on improvement in health outcomes, and durability of those outcomes. If there are no data on those elements, it is difficult for CMS to make an evidence-based decision whether the device is reasonable and necessary for the Medicare population.
The current MCIT/R&N final rule does not specify any coverage criteria beyond the FDA indications for use for which FDA has approved or cleared the device.
The current final rule would provide coverage when a device is used according to approved or cleared indications for use. A devices approved or cleared indications for use may not include information that is important or particularly relevant for Medicare patients and clinicians when making treatment decisions. With breakthrough devices, as mentioned by some commenters, the patients included in device studies generally are not Medicare beneficiaries who often have multiple comorbidities and higher acuity of illness.
The data used to determine whether a device meets applicable FDA safety
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