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Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® and Keystone Health Plan^® Central. Independent licensees of the BlueCross BlueShield Association serving 21 counties in Central Pennsylvania and the Lehigh Valley. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies.

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Medical policy: Experimental and Investigational Procedures

Policy number: MP 4.002

Clinical benefit

Minimize safety risk or concern.
Minimize harmful or ineffective interventions.
Assure appropriate level of care.
Assure appropriate duration of service for interventions.
Assure that recommended medical prerequisites have been met.
Assure appropriate site of treatment or service.

Effective date: 3/1/2026

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, 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. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

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

N/A

Definitions

N/A

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 member’s 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.

Procedure codes: Cardiac
33267	33269	33370	75577	0331T
0332T	0345T	0505T	0531T	0532T
0541T	0542T	0543T	0544T	0545T
0569T	0570T	0613T	0620T	0643T
0644T	0645T	0695T	0696T	0716T
0744T	0745T	0746T	0747T	0764T
0765T	0793T	0805T	0806T	0893T
0897T	0899T	0900T	0902T	0903T
0904T	0905T	0932T	0937T	0938T
0939T	0940T	0962T	0981T	0982T
0983T	0992T	0993T	C1735	C1736
C1761	C9760	C9782	C9783	C9786
C9792	S9025

Procedure codes: Endocrinology
0338T	0339T	0602T	0603T	0686T

Procedure codes: Eyes
0100T	0329T	0439T	0444T	0445T
0469T	0472T	0473T	0506T	0660T
0661T	0730T	0810T	0936T	L8608

Procedure codes: Face, head, neck
30468	30469	31242	31243	0583T
0639T	0725T	0726T	0727T	0728T
0729T	0951T	0952T	0953T	0954T
0955T	0978T	0979T	0980T

Procedure codes: Gastroenterology
43754	53451	53452	53453	53454
0652T	0653T	0654T	0736T	0884T
0885T	A9268	A9269	C9796	E0350
E0352

Procedure codes: Genitourinary
52250	52284	52443	0596T	0597T
0664T	0665T	0666T	0667T	0668T
0669T	0670T	0714T	0738T	0739T
0867T	0870T	0871T	0872T	0873T
0874T	0875T	0886T	0888T	0898T
0935T	0990T	0991T	A6590	A6591
E0715	S9002	51020

Procedure codes: Injections
51605	0481T	0627T	0628T	0629T
0630T	0708T	0709T	0732T	0748T
0814T	0869T	J1726	J3570	J7355

Procedure codes: Integumentary
0598T	0599T	C8002

Procedure codes: Lab services
82965	82965	83884	83884	85170
85170	85547	85547	87003	87003
87467	87467	90584	90624	90637
90638	91132	91133	94690	0015M
0020M	0025U	0061U	0063U	0067U
0077U	0095U	0105U	0106U	0107U
0110U	0115U	0116U	0117U	0119U
0121U	0122U	0123U	0220U	0221U
0243U	0247U	0288U	0290U	0295U
0303U	0304U	0305U	0310U	0331U
0345U	0346U	0356U	0372U	0384U
0385U	0387U	0389U	0390U	0394U
0395U	0398U	0401U	0404U	0406U
0407U	0418U	0439U	0440U	0443U
0457U	0458U	0463U	0464U	0466U
0472U	0482U	0483U	0484U	0487U
0496U	0500U	0501U	0502U	0506U
0511U	0512U	0522U	0524U	0531U
0532U	0535U	0537U	0541U	0542U
0545U	0546U	0547U	0548U	0577U
0579U	0580U	0581U	0587U	0588U
0589U	0591U	0558U	0559U	0563U
0564U	0570U	0573U	0599U	0599U
0601U	0604U	0607U	0608U	P2028
P2029	P2031	P2033	P2038

Procedure codes: Miscellaneous
15920	27080	30210	37650	0234T
0235T	0236T	0237T	0238T	0403T
0437T	0731T	0733T	0734T	0737T
0740T	0741T	0749T	0750T	0766T
0767T	0770T	0771T	0772T	0773T
0774T	0776T	0777T	0791T	0792T
0794T	0804T	0826T	0868T	0882T
0883T	0956T	0957T	0958T	0959T
0960T	0967T	0968T	0969T	0994T
0995T	1002T	1004T	1005T	1006T
1007T	1008T	1009T	1013T	1014T
1015T	1016T	1017T	1018T	1020T
1025T	A2036	A2037	A2038	A2039
A4544	A4594	A9291	C1600	C1831
C7500	C9764	C9765	C9766	C9767
C9772	C9773	C9774	C9775	E0738
E0739

Procedure codes: Musculoskeletal
0547T	0554T	0555T	0557T	0691T
0717T	0718T	0719T	0743T	0778T
0779T	0815T	0901T	0946T	0999T
1000T	1001T	C9781

Procedure codes: Radiology
0347T	0348T	0349T	0350T	0351T
0352T	0353T	0354T	0358T	0422T
0443T	0558T	0559T	0560T	0561T
0562T	0635T	0636T	0637T	0638T
0648T	0649T	0689T	0690T	0694T
0697T	0698T	0710T	0711T	0712T
0713T	0721T	0723T	0857T	0865T
0866T	0876T	0889T	0890T	0891T
0892T	0997T	0998T	A9586	C9762
G0566

Procedure codes: Respiratory
0174T	0175T	0632T	0781T	0782T
0807T	0808T	0877T	0878T	0879T
0880T	A7021	E0469	31660	31661

Procedure codes: Vaccines
90584	90624	90637	90638	90382
90612	90613	90631

References

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
MP 4.002	05/29/2020 Administrative update. Added new codes effective 07/01/2020: C1748, C1849, C9059, C9061, C9063, C9122, C9760, C9762, C9763, C9764, C9765, C9766, C9767, 0596T, 0597T, 0598T, 0599T, 0602T, 0603T, 0613T, 0616T, 0619T.
	09/08/2020 Administrative update. Deleted codes: C9059, C9061, C9063. Added codes: 0015M, 0210U, 0214U, 0215U, 0216U, 0217U, 0218U, 0220U, 0221U, 0222U, C9768, K1007, K1009, K1010, K1011, K1012.
	11/30/2020 Administrative update. Added new codes 0623T, 0624T, 0625T, 0626T, 0633T, 0634T, 0635T, 0636T, 0637T, 0638T. Effective 01/01/2021.
	12/14/2020 Administrative update. Added new codes C9772, C9773, C9774 and C9775. Revised code C9760. Deleted codes 0124U, 0125U, 0126U, 0127U, 0128U, 0405T and C9745. Effective 01/01/2021.
	01/06/2021 Administrative update. Revised code L8701 and L8702.
	03/18/2021 Administrative update. Added CPT codes 0243U and 0247U. Deleted codes 0098U, 0099U, 0100U, K1010, K1011, K1012. Effective 04/01/2021.
	07/01/2021 Administrative update. Added new codes 0251U, 0643T, 0644T, 0645T, 0646T, 0648T, 0649T, 0652T, 0653T, 0654T, 0664T, 0665T, 0666T, 0667T, 0668T, 0669T, 0670T, 90626, 90627, 90671, 90677, C1761 and G0237.
	08/31/2021 Administrative update. Removed codes 90619, 90697, 0565T, and 0566T. Effective 10/01/2021.
	10/12/2021 Administrative update. Removed code 0484T. Effective 11/01/2021.
	10/13/2021 Minor review. Coding reviewed and updated. Policy statement unchanged. Updated references. Effective 04/01/2022.
	11/02/2021 Administrative update. Removed code 0356T. Effective 12/01/2021.
	11/17/2021 Administrative update. Updated code G0237 to G0327 as this was an error. Effective 12/01/2021.
	12/01/2021 Administrative update. Multiple code deletions and additions. Effective 01/01/2022.
	01/05/2022 Administrative update. Removed codes 0489T–0490T. Effective 02/01/2022.
	03/11/2022 Administrative update. Code updates effective 04/01/2022.
	04/07/2022 Administrative update. Removed CPT 81514. Effective 05/01/2022.
	06/09/2022 Administrative update. Added CPT and HCPCS codes effective 07/01/2022.
	06/23/2022 Minor review. Coding reviewed and updated. Policy statement unchanged. Effective 11/01/2022.
	09/14/2022 Administrative update. Added CPT codes effective 10/01/2022.
	12/02/2022 Administrative update. Added and deleted multiple codes. Effective 01/01/2023.
	01/12/2023 Administrative update. Code changes effective 04/01/2023.
	01/17/2023 Administrative update. Added vaccine codes effective 03/01/2023.
	04/03/2023 Administrative update. Added 0088U. Effective 05/01/2023.
	05/08/2023 Administrative update. Added J1726. Effective 06/01/2023.
	06/05/2023 Administrative update. Extensive vaccine and code updates effective 07/01/2023.
	06/14/2023 Administrative update. Added CPT and HCPCS codes effective 07/01/2023.
	07/06/2023 Administrative update. Code updates effective 08/01/2023.
	08/04/2023 Administrative update. Code updates effective 09/01/2023.
	09/07/2023 Administrative update. Code updates effective 10/01/2023.
	10/05/2023 Administrative update. Code removals effective 11/01/2023.
	10/12/2023 Minor review. Removed multiple CPT codes.
	12/13/2023 Administrative update. Major vaccine and CPT cleanup. Effective 01/01/2024.
	03/15/2024 Administrative update. Code changes effective 04/01/2024.
	04/09/2024 Administrative update. Added codes effective 06/01/2024.
	06/05/2024 Administrative update. Code changes effective 07/01/2024.
	06/10/2024 Administrative update. Extensive code updates effective 07/01/2024.
	07/08/2024 Administrative update. Removed code 0402U. Effective 08/01/2024.
	09/18/2024 Administrative update. Added multiple codes effective 10/01/2024.
	10/16/2024 Minor review. Removed multiple CPT and HCPCS codes.
	12/11/2024 Administrative update. Code changes effective 01/01/2025.
	01/07/2025 Administrative update. Removed G0561; added 0484U effective 02/01/2025.
	01/10/2025 Administrative update. Added J9037 effective 03/01/2025.
	01/22/2025 Administrative update. Removed 0376U (moved to MP 2.280). Effective 05/01/2025.
	03/12/2025 Administrative update. Extensive code changes effective 04/01/2025.
	05/01/2025 Administrative update. Added multiple procedure codes effective 06/01/2025.
	06/02/2025 Administrative update. Added code 94690 effective 09/01/2025.
	06/10/2025 Administrative update. Removed Benefit Variations Section and updated Disclaimer.
	06/10/2025 Administrative update. Added multiple CPT and vaccine codes.
	07/15/2025 Minor review. No changes to policy statement.
	09/09/2025 Administrative update. Code updates effective 10/01/2025.
	11/07/2025 Administrative update. Removed code 90382 effective 12/01/2025.
	12/12/2025 Administrative update. Code changes effective 01/01/2026.
	02/03/2026 Administrative update. Added 31660, 31661, 51020. Removed 0590U, 0593U, 0707T. Effective 03/01/2026.

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Medical policy: Experimental and Investigational Procedures

Policy number: MP 4.002

Clinical benefit

Policy

Cross-references:

Product variations

Description/Background

Rationale

Definitions

Disclaimer

Coding information

Procedure codes: Cardiac

Procedure codes: Endocrinology

Procedure codes: Eyes

Procedure codes: Face, head, neck

Procedure codes: Gastroenterology

Procedure codes: Genitourinary

Procedure codes: Injections

Procedure codes: Integumentary

Procedure codes: Lab services

Procedure codes: Miscellaneous

Procedure codes: Musculoskeletal

Procedure codes: Radiology

Procedure codes: Respiratory

Procedure codes: Vaccines

References

Policy history