Experimental and Investigational Procedures

Policy Number: MA 4.002

Effective Date 9/1/2025

Policy

A service or supply, including, but not limited to, a drug, treatment, device, or procedure is considered experimental or investigational if any of the following criteria are met:

• It cannot be lawfully marketed without the approval of the Food and Drug Administration (FDA) and final approval is not granted at the time of its use or proposed use;
• It is the subject of a current investigational new drug or new device application on file with the FDA;
• The predominant opinion among experts as expressed in medical literature is that usage should be largely confined to research settings;
• The predominant opinion among experts as expressed in medical literature is that further research is needed in order to define safety, toxicity, effectiveness or effectiveness compared with other approved alternatives; or
• It is not investigational in itself but would not be medically necessary except for its use with a drug, device, treatment or procedure that is investigational or experimental.

When determining whether a drug, treatment, device, or procedure is experimental or investigational, the following information may be considered:

• The member’s medical record;
• The protocol(s) pursuant to which the treatment is to be delivered;
• Any consent document the patient has signed or will be asked to sign, in order to undergo the procedure;
• The referenced medical or scientific literature regarding the procedure at issue as applied to the injury or illness at issue;
• Regulations and other official actions and publications issued by the federal government; and
• The opinion of a third-party medical expert in the field, obtained by Capital Blue Cross, with respect to whether a treatment or procedure is experimental or investigational.

Cross-references

• MP 2.010 Clinical Trials and Expanded Access Services
• MP 2.103 Off-Label Use of Medications

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations as discussed in Section VI. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual. The FEP Medical Policy manual can be found at: https://www.fepblue.org/benefit-plans/medical-policies-and-utilization-management-guidelines/medical-policies

Description/background

Experimental and investigational services (e.g., devices, drugs, procedures, supplies, technologies, treatments) are services whose safety or efficacy is not known or are services that are used in a way that departs from generally accepted standards of practice in the medical community.

Rationale

NA

Definitions

NA

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 required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies 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 may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

References

1. Blue Cross and Blue Shield Association Medical Policy Program Policies and Procedures.
2. Centers for Medicare and Medicaid Services (CMS) Medicare Benefit Policy Manual. Publication 100-02. Chapter 14. Medical Devices. Rev. 1. Effective 10/01/03.

Policy History

• MA 4.002 - 04/02/2025 Policy creation; Partial Adoption

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.