CMS Finalizes Definition of “Reasonable and Necessary”

▤ Summary

As previously reported this rule also establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). As part of this, the Centers for Medicare & Medicaid Services (CMS) will codify the definition of reasonable and necessary to align with the goals of MCIT. CMS finalized that an item or service would be considered ‘‘reasonable and necessary’’ if it is • not experimental or investigational; and • appropriate for Medicare patients, 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 patient’s condition or to improve the function of a malformed body member; • Furnished in a setting appropriate to the patient’s medical needs and condition; • One that meets, but does not exceed, the patient’s medical need; and • At least as beneficial as an existing and available medically appropriate alternative • Covered in the commercial insurance market, except where evidence supports that there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals. CMS will consider coverage to the extent the items or services are covered by most commercial insurers. 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 the majority of covered lives.

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