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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
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and will not adopt the commenters suggestion.
Comment: Commenters questioned whether the reasonable and necessary definition would apply to items and services beyond devices.
Response: Yes, the reasonable and necessary definition applies to all items and services Medicare covers under Part A and Part B. This includes, but may not be limited to, drugs, devices and biologics. Medicare Advantage plans are required to offer coverage of these items and services on terms at least as permissive as those adopted by fee for service Medicare under this policy.
Comment: CMS received a few comments regarding broadening the definition of reasonable and necessary to include prevention and screening items and services.
Response: We are not adopting this suggestion because Congress has made express exceptions to 1862a1A in order to provide Medicare coverage for covers. Because those services are based on statutory authorities. CMS has already issue specific regulations for those services, it is not necessary or appropriate to amend the regulations defining reasonable and necessary to include preventive measures.
Safe and Effective Comment: Several comments stated that CMS should further define what it means by safe and effective. For example, one commenter recommend that evidence-based guidelines that should be considered for meeting the safe and effective criteria. In addition, we had other comments state that FDA
market authorization should meet the safe and effective criterion. However, other commenters state that there are items and services not regulated by the FDA; therefore, CMS should not further define this criterion to FDA-market authorization/approval.
Response: The requirement of safe and effective is a long-standing part of the definition of reasonable and necessary. CMS believes the longstanding factor is an appropriate starting point for a definition, with minor technical changes as proposed and then finalized in this rule.
Comment: CMS should establish its own stand-alone criteria that allows for investigational and experimental treatment to be deemed to be reasonable and necessary.
Response: CMS has stand-alone criteria that allows for coverage of certain investigational and experimental items and services. CMS covers certain Investigational Device Exemptions IDE
devices under 42 CFR 405 Subpart B.
In addition, CMS also covers certain
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investigational items under the Clinical Trial Policy see https www.cms.gov/
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Appropriate for Medicare Patients Comment: Commenters requested more clarification on how the appropriateness criteria may be applied.
For example, one commenter requested CMS further explain at least as beneficial. Another commenter requested clarification regarding appropriate setting.
Response: Because this is a longstanding definition and we are not making significant changes, we believe implementation will have no effect on its application to claim-by-claim adjudication, LCDs or NCDs. We also note that all NCDs and LCDs must go through a transparent process that includes opportunities for full stakeholder engagement when applying the reasonable and necessary definition criteria, including at least as beneficial.
Comment: A few commenters requested that CMS update the appropriateness standard that states, . . . 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 to include additional criteria such as improve, maintain, or prevent.
Response: This long-standing definition allows flexibility and consistency to Medicare coverage process. By continuing to use the longstanding definition, there should not be any changes to its applicability when making coverage determinations. We note that prevention is addressed in statute and regulation elsewhere see 1861ddd and 42 CFR 410.64. Further, under 1862a1A, the statute states diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. The longstanding definition, while not a direct quote, uses the same terms in the statute.
Comment: Some public commenters suggested that MACs must maintain flexibility for determining what is appropriate on case-by-case basis, because this factor turns on particular medical facts. They suggested that finalizing the regulatory proposal could mean patients with rare conditions are overlooked because appropriate for Medicare patients means decisions are not individualized.
Response: We appreciate commenters feedback. We agree that the appropriate factor is made based on the
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consideration of specific facts and that MACs should continue to adjudicate individual claims to ensure that they are reasonable and necessary, in the absence of a NCD. We also agree that it is important to consider whether an item or service is reasonable and necessary when making NCDs that often apply to a particular patient population.
Because it is the same long-standing definition, we do not believe the application of reasonable and necessary determinations on a case-by-case determination, LCDs or NCDs will change. Specifically, for treatments for rare diseases. The application of appropriateness for a small population may be best addressed as a claim-byclaim decision that takes into consideration the individual patients clinical situation. The MAC will continue to have the flexibility to decide the best approach to coverage on a local level.
Comment: One commenter stated that the definition of appropriateness for Medicare beneficiaries should ensure all beneficiaries are considerednot just the aged.
Response: We thank commenters for their input. We agree that it is important to consider the entire Medicare population, including beneficiaries younger than age 65, when deciding whether an item or service is reasonable and necessary.
3 Commercial Insurer Policy Utilization Comment: Commenters point out that review of commercial insurer policies to be the sole determinant of appropriate coverage is a substantial policy change and needs more stakeholder input. The commenters state that the proposal is vague, stated over 25
questions, and provided little detail to support framework. Commenters questioned why CMS would need to codify this when the agency has already used its authority to look to commercial policies. One commenter outlined several questions CMS should ask the public to ensure we have appropriate stakeholder input and information before finalizing a definition.
Response: At this time, we are not codifying the proposed modification to the PIM definition that allows commercial insurers to be the sole determinant. As some commenters pointed out CMS currently has the authority and has exercised this authority in the past to review commercial insurer policies as part of the NCD development process.
However, we are including regulatory language that will give CMS clear authority to review the majority of
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