CMS Proposes Definition of Reasonable and Necessary

Posted on Monday, September 21, 2020

A definition of “reasonable and necessary” was part of the recently proposed rule, Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘‘Reasonable and Necessary’’.  This proposed rule would also establish 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).  Once effective, the Medicare Coverage of Innovative Technology (MCIT) pathway would begin national Medicare coverage on the date of authorization and would continue for four years.

“CMS proposes that an item or service would be 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 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;
  • 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.”

Source: NAHC Report


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