On January 12, 2021, CMS released the “Medicare Coverage of Innovation Technology (MCIT) and Definition of Reasonable and Necessary” final rule (CMS-3372-F). This rule establishes Medicare coverage for new and innovative technologies that are designated as “breakthrough” by the FDA (as defined in Section 3051 of the 21st Century Cures Act) to facilitate faster beneficiary access to potentially life-saving items or services. The MCIT rule will provide national Medicare coverage for four years, from as early as the date of FDA approval, so innovators do not have to seek local coverage determinations (LCDs) from each Medicare Administrative Contractor (MAC) prior to determining coverage.
In addition, the rule codifies the definition of “reasonable and necessary” found in the Medicare Program Integrity Manual (Chap 13, §13.5.4) in regulation.
“An item or service is considered reasonable and necessary if it is:
1. Safe and effective;
2. Not experimental or investigational; and
3. 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 and 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;
- Ordered and furnished by qualified personnel;
- 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.”
For more information, access the CMS Press Release.
Access the Final Rule.