Latest Review Date:   January 2024

Category:  Administrative        

POLICY:

The terms “medical necessity” or “medically necessary” are applied to those health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a medical practitioner, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

• in accordance with generally accepted standards of medical practice; and
• clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
• not primarily for the convenience of the patient, physician or other health care provider; and
• not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.

For these purposes, "generally accepted standards of medical practice" means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors.

Additionally, the medical services must meet all five criteria established by the Blue Cross Blue Shield Association’s Technology Evaluation Center:

 1. The technology must have final approval from the appropriate government regulatory bodies.

• This criterion applies to drugs, biological products, devices and diagnostics.
• A drug or biological product must have final approval from the Food and Drug Administration (FDA), any approval granted as an interim step in the FDA regulatory process is not sufficient.
• A device must have final approval from the Food and Drug Administration.

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.

• The evidence should consist of well-designed and well-conducted investigations published in peer-reviewed English-language journals. The qualities of the body of studies and the consistency of the results are considered in evaluating the evidence.
• The evidence should demonstrate that the technology can measurably alter the physiological changes related to a disease, injury, illness or condition. In addition there should be evidence or a convincing argument based on established medical facts that the measured alterations affect health outcomes.
• Opinions and evaluations by national medical associations, consensus panels or other technology evaluation bodies are evaluated according to the scientific quality of the supporting evidence upon which they are based.

3. The technology must improve the net health outcome.

• The technology’s beneficial effects on health outcomes should outweigh any harmful effects on health outcomes.

4. The technology must be as beneficial as any established alternatives.

• The technology should improve the net health outcome as much as or more than established alternatives.
• The technology must be cost-effective as any established alternatives that achieve a similar health outcome.

5. The improvement must be attainable outside the investigational settings.

• When used under the usual conditions of medical practice, the technology should be reasonably expected to improve health outcomes to a degree comparable to that.

If a specific procedure, treatment, supply, device, or drug is determined to be investigational and/or not medically necessary in accordance with another medical policy of the plan's, that medical policy governs. 

KEY WORDS:

Medical necessity, medically necessary, coverage criteria

APPROVED BY GOVERNING BODIES:

This includes product approvals issued by the Food and Drug Administration, an agency of the United States Department of Health & Human Services.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Covered if covered by the Participating Home Plan

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

Not applicable

REFERENCES:

1. Institute of Medicine (US) Council on Health Care Technology; Goodman C, editor. Medical Technology Assessment Directory: A Pilot Reference To Organizations, Assessments, and Information Resources. Washington (DC): National Academies Press (US); 1988. Blue Cross and Blue Shield Association Technology Evaluation and Coverage Program.

POLICY HISTORY:

Medical Policy Group, December 2020 (4): New policy adopted.

Medical Policy Administrative Committee: January 2020

Medical Policy Group, March 2021 (4):  Added clarification verbiage:  "If a specific procedure, treatment, supply, device, or drug is determined to be investigational and/or not medically necessary in accordance with another medical policy of the plan's, that medical policy governs."  No change to policy intent.

Medical Policy Group, January 2022 (4): Reviewed by consensus. No change to policy statements.

Medical Policy Group, January 2023 (4): Reviewed by consensus. No change to policy statements.

Medical Policy Group January 2024 (4): Reviewed by consensus.  No change to policy statements.

This medical policy is not an authorization, certification, explanation of benefits, or a contract.Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient.

The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity

and only if services or supplies are not investigational, provided the customer group contracts

have such coverage.