Policy title: Experimental and Investigational Procedures

Policy number: MA 4.002

Effective date: 7/1/2026

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.

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

Cross-references

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

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 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.

Procedure Codes

References

1. 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
• 11/07/2025 Administrative update. Removed code 90382. Effective 12/01/2025.
• 12/12/2025 Administrative update. Deleted codes 0361U, 0508U, 0509U, 0544U, 0619T, 0624T. Added codes 0601U, 0604U 0607U, 0608U, 0990T, 0991T, 0992T, 0993T, 0994T, 0995T, 0997T, 0998T, 0999T, 1000T, 1001T, 1002T, 1004T, 1005T, 1006T, 1007T, 1008T, 1009T, 1013T, 1014T, 1015T, 1016T, 1017T, 1018T, 1020T, 1025T, 52443, 75577, 90631, 0468U, 0344U, 86305, A4543, A4596, J7402, 77086, 0607T, 0608T, 0933T, 0934T, 0609U. Effective 01/01/2026.
• 01/05/2026 Administrative update. Added codes J0591, 0419T, 0420T, 17340, 69090. Effective 02/01/2026.
• 02/03/2026 Administrative update. Added codes 31660, 31661, 51020. Removed codes 0590U, 0593U, 0609U, 0338T, 0339T, 0935T, C1735, C1736, 0707T. Effective 03/01/2026.
• 02/24/2026 Minor Review. Removed codes A9268, A9269, E0715, P2031, 0469T,0749T, 0750T, 0792T, 0707T, 0739T, 0804T, 0889T-0892T, 69090, 77086, 17340, PLA Codes, 15011-15018.
• 03/09/2026 Administrative update. Added codes 0615U-0620U, 0623U-0626U, 0628U-0630U, G0860, A8005, A8006, A9294, C8010. Removed 83884. Effective 04/01/2026.
• 04/13/2026 Administrative update. Added 0397T. Effective 05/01/2026.
• 04/22/2026 Administrative update. Removed 90624. Effective 05/01/2026.
• 06/05/2026 Administrative Update. Added codes 1026T-1043T, 1050T-1053T, 90616, 90639. Effective 07/01/2026

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.