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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
will be largely driven by whether the manufacturer has questions for CMS, or CMS and FDA. The timing of coverage will be left to the manufacturers discretion provided they request to enter the MCIT pathway within the four year timeframe for which they would be eligible to participate. Engagements can take place in the form of in-person meetings, phone calls, emails, etc. We intend to put devices that are covered through the MCIT pathway on the CMS
website so that all stakeholders will be aware of what is covered through the MCIT pathway. This measure was completely supported by the public comments. Manufacturers of breakthrough devices will not be obligated or mandated by CMS to conduct clinical studies during coverage under the proposed MCIT pathway.
However, we sought comment as to whether CMS should require or incentivize manufacturers to provide data about outcomes or should be obligated to enter into a clinical study similar to CMSs Coverage with Evidence Development CED
paradigm.13 We are aware some manufacturers may be required by the FDA to conduct post market data collection as a condition of market authorization, and nothing in this proposed rule would alter that FDA
requirement. Manufacturers are encouraged to develop the clinical evidence base needed for one of the other coverage pathways after the MCIT
pathway ends. This evidence is encouraged not only for CMS and commercial health insurer coverage policies but also to better inform the clinical community and the public generally about the risks and benefits of treatment. CMS encourages early manufacturer engagement, both before and after FDA market authorization, for manufacturers to receive feedback from CMS on potential clinical study designs and clinical endpoints that may produce the evidence needed for a definitive coverage determination after MCIT. This feedback would not involve CMS
predicting specific coverage or noncoverage.
In order to further the goals of E.O.
13890, CMS proposed to rely on FDAs breakthrough device designation and market authorization of those devices to define the universe of devices eligible for MCIT, except for those particular devices CMS determines do not have a Medicare benefit category or are
statutorily excluded from coverage under Part A or Part B. We proposed to establish a four year time limit on how long a breakthrough device can be eligible for MCIT that is, considered a breakthrough device for coverage purposes. The 4 year coverage period is particularly important for manufacturers of breakthrough devices that choose to further develop the clinical evidence basis on which the FDA granted marketing authorization. From our experience with clinical studies conducted as part of an NCD, 4 years is approximately the amount of time it takes to complete a study.
At the end of the 4-year MCIT
pathway, coverage of the breakthrough device would be subject to one of these possible outcomes: 1 NCD affirmative coverage, which may include facility or patient criteria; 2 NCD non-coverage;
or 3 MAC discretion claim-by-claim adjudication or LCD. Manufacturers that are interested in a NCD are encouraged to submit a NCD request during the third year of MCIT to allow for sufficient time for NCD
development. We sought public comment on whether CMS should open a national coverage analysis if a MAC
has not issued an LCD for a breakthrough device within 6 months of the expiration date of the 4-year MCIT
period.
We sought public comment on the proposed MCIT pathway, the considerations described, whether any of the existing coverage pathways should be modified to achieve the goals set out by the E.O., and solicited alternatives to these proposals. We specifically sought public comment 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 14 or all diagnostics, drugs and/or biologics. We sought data to support including these additional item categories in the MCIT pathway. Also, we specifically sought manufacturer input on whether an opt-in or opt-out approach would work best for utilizing the MCIT pathway. We believe manufactures will welcome this new coverage pathway. We want to preserve manufacturers business judgment and not assume which Medicare coverage pathway a given manufacturer of a breakthrough device would prefer if any. Therefore, we proposed an opt-in
13 CMS, Guidance for the Public, Industry, and CMS Staff Coverage with Evidence Development, available at https www.cms.gov/medicarecoverage-database/details/medicare-coveragedocument-details.aspx?MCDId=27.

14 Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review, available at https
www.fda.gov/patients/learn-about-drug-and-deviceapprovals/fast-track-breakthrough-therapyaccelerated-approval-priority-review.

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approach with an email to CMS to indicate affirmative interest in coverage.
We expressed interest in whether an opt-out approach would be less burdensome for stakeholders. We encouraged public comment on a process for stakeholders to opt-out of MCIT that would not be burdensome.
Also, we sought public comment on whether, once a manufacturer has opted-out of coverage, it can subsequently opt-in to MCIT.
Comment: The majority of comments generated by our questions concern issuing an NCD at the end of the four year period did not support CMS
automatically opening an NCD if MACs had not issued an LCD after 6 months.
One commenter stated that the 6 month timing was arbitrary with another stated that 6 months would not be enough time for MACs to perform a comprehensive analysis as data may not be fully available or there may be LCDs inprocess at the 6 month mark. Many manufacturers cited the desire for flexibility in the timing of requesting an NCD and some specifically cited support for claim by claim adjudication by the MACs and believe that FDA
approved or cleared indications will be covered by MACs on a claim by claim basis. Some commenters did not want automatic LCDs or NCDs but wanted assurance that absent those mechanisms the MACs would, on a claim by claim basis, cover MCIT graduated technologies consistent with their FDA
approved or cleared indications. A few commenters supported some version of a process by which an NCD would automatically be triggered including that the manufacturer would be required to submit an NCD request during year 3
of MCIT coverage and requiring the NCD to be complete by the end of year 4. A few commenters expressed general concern for potential uncertainty among patients and providers regarding whether MCIT coverage of a device would continue past year 4. One commenter noted that submission of requests for NCDs and LCDs are not restricted to manufacturers, anyone can submit a request.
Response: We appreciate commenters input. We agree that manufacturers should have flexibility in timing their request for an NCD under MCIT so that they can adequately prepare to market the device and satisfy consumer expectations. We further believe that flexibility in the case of timing for the development of LCDs and NCDs would be in the best interest of beneficiaries, manufacturers and providers. We believe that there will be situations in which not enough evidence will be available on which an LCD or NCD can
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