Medicare Managed Care Manual (Pub. 100-16), Ch. 4 § 10.16
Medical Necessity
10.16 – Medical Necessity
(Rev. 121, Issued: 04-22-16, Effective: 04-22-16, Implementation: 04-22-16)
Every MA plan:
• Must have policies and procedures, that is, coverage rules, practice guidelines,
payment policies, and utilization management, that allow for individual medical
necessity determinations (42 CFR §422.112(a)(6)(ii));
• Must employ a medical director who is responsible for ensuring the clinical accuracy
of all organization determinations and reconsiderations involving medical necessity.
The medical director must be a physician with a current and unrestricted license to
practice medicine in a State, Territory, Commonwealth of the United States (that is,
Puerto Rico), or the District of Columbia (42 CFR §422.562(a)(4));
• If the MAO expects to issue a partially or fully adverse medical necessity (or any
substantively equivalent term used to describe the concept of medical necessity)
decision based on the initial review of the request, the organization determination
must be reviewed by a physician or other appropriate health care professional with
sufficient medical and other expertise, including knowledge of Medicare coverage
criteria, before the MAO issues the organization determination decision. The
physician or other health care professional must have a current and unrestricted
license to practice within the scope of his or her profession in a State, Territory,
Commonwealth of the United States (that is, Puerto Rico), or the District of Columbia
(42 CFR §422.566(d), MMCM chapter 13, 40.1.1);
• Must make determinations based on: (1) the medical necessity of plan-covered
services - including emergency, urgent care and post-stabilization - based on internal
policies (including coverage criteria no more restrictive than original Medicare’s
national and local coverage policies) reviewed and approved by the medical director;
(2) where appropriate, involvement of the organization’s medical director per 42 CFR
§422.562(a)(4); and (3) the enrollee's medical history (e.g., diagnoses, conditions,
functional status), physician recommendations, and clinical notes. Furthermore, if the
plan approved the furnishing of a service through an advance determination of
coverage, it may not deny coverage later on the basis of a lack of medical necessity
(Program Integrity Manual, chapter 6, Section 6.1.3(A)); and
• Must accept and process appeals consistent with the rules set forth at 42 CFR Part
422, Subpart M, and chapter 13 of the MMCM.