CMS seeks to modify 'reasonable and necessary,' establish MCIT

WASHINGTON - CMS has published a proposed rule that seeks to codify in regulations the definition of “reasonable and necessary” with modifications, including adding a reference to Medicare patients and a reference to commercial health insurer coverage policies.

CMS proposes that an item or service would be considered “reasonable and necessary” if it is safe and effective; 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 1) is furnished in accordance with accepted standards, 2) is furnished in a setting appropriate to the patient's medical needs and condition, 3) is ordered and furnished by qualified personnel, 4) meets but does not exceed the patient's medical need and 5) is at least as beneficial as an existing and available medically appropriate alternative.

CMS also proposes that an item or service would be “appropriate for Medicare patients” if it is covered in the commercial insurance market, except where evidence supports there are clinically relevant differences between Medicare beneficiaries and commercially insured individuals.

Additionally, CMS proposes creating a Medicare Coverage of Innovative Technology (MCIT) pathway to accelerate the coverage of new, innovative breakthrough devices to Medicare beneficiaries. The pathway would provide national coverage, simultaneously with approval from the U.S. Food and Drug Administration, for a period of four years, meaning innovators would not need to seek coverage from the MACs. After four years, CMS may reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among beneficiaries.