Electronic Code of Federal Regulations

Amendment

42 CFR--PART 405

Amendment(s) published January 14, 2021, in 86 FR 3009

Effective Dates: Mar. 15, 2021

2. Section 405.201 is amended in paragraph (b) by adding a definition for “Reasonable and necessary” in alphabetical order to read as follows:

§405.201   Scope of subpart and definitions.

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(b) *  *  *

Reasonable and necessary means that an item or service is considered—

(i) Safe and effective;

(ii) Except as set forth in §411.15(o) of this chapter, not experimental or investigational; and

(iii) Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it meets all of the following criteria:

(A) Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;

(B) Furnished in a setting appropriate to the patient's medical needs and condition;

(C) Ordered and furnished by qualified personnel;

(D) Meets, but does not exceed, the patient's medical need; and

(E) Is at least as beneficial as an existing and available medically appropriate alternative; or

(F) Not later than March 15, 2022, CMS will issue draft subregulatory guidance on the methodology of which commercial insurers are relevant based on the measurement of majority of covered lives. For national and local coverage determinations, which have insufficient evidence to meet paragraphs (b)(3)(i) through (v) of this section, CMS will consider coverage to the extent the items or services are covered by a majority of commercial insurers. As part of CMS' consideration, CMS will include in the national or local coverage determination its reasoning for its decision if coverage is different than the majority of commercial insurers.

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