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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations be made and claim by claim adjudication is most appropriate, if even temporarily while the data continues to be developed. A 6-month timeframe may not be appropriate in all situations so this one size fits all approach to trigger an NCD at 6 months after the close of the 4 year MCIT coverage period is not flexible enough to account for the various levels of evidence that may be available. We are not able to require MACs to adjudicate claims for a particular result, this merely sidesteps the NCD process. However, we note that manufacturers and providers can discuss technologies with the clinical staff and medical directors working for each MAC. We also appreciate and are sensitive to the concern over the continuity of care for patients who are using breakthrough devices and find it important to state that beneficiaries with a device covered under MCIT will continue coverage of any routine services or complications related to that device beyond the 4-year period of MCIT coverage. After considering the comments, we are not making any changes in the final rule with respect to the possible outcomes at the end of the 4-year MCIT pathway, which are: 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. CMS will not automatically open a national coverage analysis within six months of the expiration four year MCIT period.
Comment: CMS received overwhelming support from commenters in favor of the voluntary, opt-in model of MCIT as proposed because it allows manufacturers to use their judgment in determining whether to participate. Some of the commenters who supported opting-in also added that communicating with CMS for entry into the MCIT program would be beneficial for both parties by encouraging discussion about the technology, coding, payment, and the evidentiary expectations after 4 years of coverage under MCIT. Another commenter indicated that opting-in would not be burdensome and would not likely be a deterrent to MCIT
participation. A small number of commenters were in favor of automatic participation in MCIT unless a manufacturer chose to opt-out. One of these commenters cited the likelihood of administrative errors that could occur which could delay opting-in and would
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inadvertently exclude a manufacturer from MCIT.
Response: We agree with commenters that supported the voluntary, opt-in model for the MCIT program. Of the commenters that had concerns, we believe their concerns will be addressed by finalizing that manufacturers may opt-into MCIT using no more than an email from the manufacturer to CMS
indicating a desire to opt-in and the requested start date of MCIT coverage.
We believe that this should ensure a simple engagement with CMS to opt and will limit burden and improve collaboration with CMS. Commenters who expressed support for the opt-in model spoke to increased collaboration with CMS. Commenters who supported the opt-out method in order to limit administrative burden and confusion will be pleased by the simplicity of and public information available for the process of opt-in. Manufacturers may request to opt-in any time during the first 2 years in which they are eligible to participate in MCIT, however, the four year coverage period begins the day the breakthrough devices receives FDA
authorization. A more complete discussion including summary of comments and responses on the fouryear coverage period and when it begins appears later in this rule.
II. Provisions of Proposed Regulations and Analysis of and Responses to Public Comments A. Defining Reasonable and Necessary As described in section I. of this final rule, the Secretary has authority to determine the meaning of reasonable and necessary under section 1862a1A of the Act. We proposed to codify the longstanding Program Integrity Manual definition of reasonable and necessary into our regulations at 42 CFR 405.201b, with modification. Under the current definition, an item or service is considered reasonable and necessary if it is 1 safe and effective; 2 not experimental or investigational; and 3
appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patients condition or to improve the function of a malformed body member;
Furnished in a setting appropriate to the patients medical needs and condition;
Ordered and furnished by qualified personnel;

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One that meets, but does not exceed, the patients medical need; and At least as beneficial as an existing and available medically appropriate alternative.
In addition to codifying the previously discussed criteria, we proposed to include a separate basis under which an item or service would be appropriate under previously stated 3 that is based on commercial health insurers coverage policies that is, nongovernmental entities that sponsor health insurance plans. We proposed the commercial market analysis would be initiated if an item/service fails to fulfill the existing factor 3 criteria defining appropriate for Medicare patients but fulfills 1 safe and effective and 2 not experimental or investigational. We believed that this approach would be in line with E.O.
13890 that directs us to make technologies widely available, consistent with the principles of patient safety, market-based policies, and value for patients. Under this separate basis, we proposed that an item or service would satisfy factor 3 if it is covered under a plans coverage policy if offered in the commercial insurance market, unless evidence supports that differences between Medicare beneficiaries and commercially insured individuals are clinically relevant.
Under our proposal, we would exclude Medicaid managed care, Medicare Advantage, and other government administered healthcare coverage programs from the types of coverage CMS would consider, as these enrollees are not in the commercial market. In the following paragraphs, we sought comment on this proposal and on how best to implement this mechanism.
We solicited comments on the following:
Sources of data that could be used to implement this policy, and whether CMS should make this information public and transparent.
Appropriate sources for these coverage policies and the best way to determine which commercial plans we would rely on for Medicare coverage.
Whether beneficiaries, providers, innovators, or others wishing to gain coverage for an item or service should demonstrate that the item or service is covered by at least one commercial insurance plan policy. If they could provide CMS with evidence of commercial coverage or if CMS or its MACs identify such coverage from its review of compilations of health insurance offerings or data from other sources, CMS would consider factor 3
to be satisfied.

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