Policy title: Medical Necessity

Policy number: MA 4.003

Effective date: 11/1/2026

Note: This policy applies to members enrolled in a Medicare Advantage plan with Capital Blue Cross (“Capital”) when the member’s Evidence of Coverage (EOC) includes the service. Coverage determinations must align the EOC. If the service is not included in the EOC, this policy may not apply. Any exceptions must be approved by the plan’s Medical Director or Utilization Management team and documented in accordance with Centers for Medicare & Medicaid Services (CMS) requirements. This policy is intended to support the plan’s Medical Director’s or Utilization Management team’s application of medical policies and clinical utilization management criteria and administration of plan benefits.

Policy

Capital follows Medicare coverage guidelines and complies with CMS policies and guidelines consistent with applicable law. CMS requires items and services provided to members to be both medically reasonable and necessary to treat or diagnose an illness or injury for Medicare coverage. Capital defines “medical necessity or medically necessary” to mean all of the following:

• Services, procedures, treatments, devices, equipment, facilities, drugs, or supplies that a physician exercising prudent clinical judgment would provide to an individual for the purpose of preventing, evaluating, diagnosing, or treating an individual’s medical condition, disease, illness, symptoms, or injury;
• In accordance with generally accepted standards of good medical practice;
• Clinically appropriate in terms of type, frequency, extent, site and duration, and considered effective for the individual’s medical condition, disease, illness, symptoms, or injury;
• Not primarily for the convenience of the individual and/or individual’s family, physician, or other health care provider; and
• Not costlier than alternative services or supplies at least as likely to produce equivalent results for the individual’s condition, disease, illness, symptoms, or injury.

For these purposes, “generally accepted standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, national physician specialty society recommendations and the views of physicians practicing in relevant clinical areas, and other clinically relevant factors. The fact that a provider may prescribe, recommend, order, or approve a service or supply does not of itself make it medical necessity or a covered benefit.

Capital Medical Policies specify the medical necessity criteria applicable to particular benefits based on assessment of the scientific evidence.

Scientific evidence and other resources reviewed include, but are not limited to:

• Decisions and recommendations of appropriate governmental regulatory bodies, such as the FDA (The Food and Drug Association), National Institutes of Health (NIH), Centers for Disease Control (CDC), Centers for Medicare and Medicaid Services (CMS), Health and Human Services (HHS), Agency for Healthcare Research and Quality (AHRQ), and the United States Preventive Services Task Force (USPSTF).
• Opinions and evaluations of national medical organizations; professional specialty societies; clinical panels, task forces, and other technology evaluation bodies.
• Available clinical evidence in published scientific literature.
• External physician reviews.

In addition to the Medical Policies, Capital utilizes InterQual criteria, which is an industry standard set of objectives, evidence-based, utilization management criteria to assist in evaluating the medical necessity and appropriateness of medical care delivered to individuals. InterQual criteria are evaluated yearly for updates and changes.

Policy Guidelines

Regulatory Status

Clearance by the Food and Drug Administration (FDA) is a prerequisite for Medicare coverage. The 510(k) premarket clearance process alone does not establish medical necessity. Medicare payment policy is determined by the combination of requirements, including but not limited to:

• The member’s Evidence of Coverage (EOC) confirming the service is a covered benefit.
• Applicable CMS regulations, National Coverage Determinations (NCDs), and Local Coverage Determinations (LCDs).
• The plan’s medical necessity criteria, based on generally accepted standards of care.
• Compliance with applicable laws.
• Any additional requirements outlined in the plan’s utilization management policies.

This medical policy applies to Medicare Advantage plans offered by Capital Blue Cross and its subsidiaries.

Description/Background

This policy defines “medical necessity or medically necessary” for coverage determination.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes is not exhaustive and may change from time to time as permitted by law or applicable clinical guidelines. The inclusion of a code in this section is not a guarantee of coverage or payment. In addition, not all covered services are eligible for separate reimbursement.

Specific procedure coding does not apply to this policy.

References

1. CMS Glossary
2. Centers for Medicare & Medicaid Services. Medicare Managed Care Manual. Chapter 4, Section 10.16 “Medical Necessity” and Section 110.1.1 “Provider Network Standards.”
3. Social Security Administration. Social Security Act, Title XVIII, Section 1862(a)(1)(A). 42 U.S.C. § 1395y(a)(1)(A).
4. Federal Register, 42 C.F.R. § 422.101(c).

Policy History

• MA 4.003
• 04/15/2026 Policy Creation.

Plans issued by Capital Blue Cross and it’s subsidiaries are independent licensees of the Blue Cross Blue Shield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.

Health care benefit programs issued or administered by Capital Blue Cross and/or its subsidiaries, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® and Keystone Health Plan^® Central. Independent licensees of the Blue Cross BlueShield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies.