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: 11/1/2026

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 permitted 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.

The following procedure codes are denied as experimental/investigational based on the guidelines of this policy:

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

1050T

1051T

1052T

1053T

1087T

C1761

C8010

C9760

C9782

C9783

C9792

S9025
Procedure codes: Endocrinology

0602T

0603T

0686T

 

 
Procedure codes: Eyes

0100T

0329T

0439T

0444T

0445T

0469T

0472T

0473T

0506T

0660T

0661T

0730T

0810T

0936T

1080T

1090T

1098T

A6614

E2403

L8608
Procedure codes: Face, Head, Neck

30468

30469

31242

31243

0583T

0639T

0725T

0726T

0727T

0728T

0729T

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

51020

52250

52443

53860

0596T

0597T

0664T

0665T

0666T

0667T

0668T

0669T

0670T

0672T

0714T

0738T

0867T

0870T

0871T

0872T

0873T

0874T

0875T

0886T

0888T

0898T

0935T

0950T

0990T

0991T

1054T

1065T

1066T

1067T

1068T

A6590

A6591

E0715

S9002

 
Procedure codes: Injections

51605

0481T

0627T

0628T

0629T

0630T

0708T

0709T

0732T

0748T

0814TT

0869T

J1726

J3570

J3575
Procedure codes: Integumentary

0598T

0599T

C8002

 

 
Procedure codes: Lab Services

90584

91132

91133

94690

 
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

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

1027T

1028T

1029T

1030T

1031T

1032T

1033T

1034T

1035T

1036T

1037T

1038T

1039T

1040T

1041T

1042T

1055T

1057T

1058T

1059T

1060T

1061T

1069T

1070T

1071T

1083T

1091T

1099T

1104T

1105T

1108T

1109T

1110T

1111T

A4544

A4594

A9291

A9294

C1600

C1831

C7500

C9764

C9765

C9766

C9767

C9772

C9773

C9774

C9775

E0738

E0739

E0743

E0767

E1905

E3200

G0276

G0680

G9147

L8720

L8721

M0075

S2103

S2107

S2400

S3904

 
Procedure codes: Musculoskeletal

0547T

0554T

0555T

0557T

0691T

0717T

0718T

0719T

0743T

0778T

0779T

0815T

0901T

0946T

0999T

1000T

1001T

1096T

1100T

1101T

A8005

A8006

C9781

 

 
Procedure codes: Radiology

77089

77090

77091

77092

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

0997T

0998T

1043T

1085T

1089T

1103T

A9586

C8001

C9762

C9793

G0566

 

 

 
Procedure codes: Respiratory

0174T

0175T

0632T

0781T

0782T

0807T

0808T

0877T

0878T

0879T

0880T

1102T

A7021

E0469

31660

31661

 

 

 

 
Procedure codes: Vaccines

90584

90637

90638

90381

90612

90613

90631

 

 

 

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

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. The following new codes added to the policy: 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. Removed codes 0139U, 0356T, 0423T, 0548T, 0549T, 0550T, 0551T, C9752, C9753. Added codes 0285U, 0288U, 0295U, 0296U, 0303U, 0304U, 0305U, 0646T, 0686T, 0689T, 0690T, 0691T, 0693T, 0694T, 0695T, 0696T, 0697T, 0698T, 0707T, 0708T, 0709T, 0710T, 0711T, 0712T, 0713T, 53452, 53453, 53454, 77089, 77090, 77091, 77092, 81560, 83529, 0297U, 0298U, 0299U, 0300U. Effective 01/01/2022.

01/05/2022 Administrative update. Removed codes 0489T-0490T. Effective 02/01/2022.

03/11/2022 Administrative update. Removed deleted code 0151U. Added new codes 0308U, 0309U, 0310U, 0312U, 0316U, 0319U, 0320U, 0321U, A9291, C9781, C9782 and C9783. Effective 04/01/2022.

04/07/2022 Administrative update. Removed CPT 81514. Effective 05/01/2022.

06/09/2022 Administrative update. Added CPT 0323U-0328U, 0331U, 0714T-0719T, 0721T-0734T, 0736T, 0737T, 90584. 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 0345U-0350U, 0353U, 0354U, C1834. Effective 10/01/2022.

12/02/2022 Administrative update. Added 30469, 87467, 90678, 0356U, 0361U, 0363U, 0738T-0750T, 0764T-0782T, C1747, C7500. Deleted 0475T-0478T, 0491T-0493T, 0499T, 0514T, Q0222, M0222, M0223. Effective 01/01/2023.

01/17/2023 Administrative update. Added 0004A, 0054A, 0064A, 0074A, 0083A, 0094A. 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. Removed 0715T. Added 0001A, 0002A, 0003A, 0011A, 0012A, 0013A, 0051A, 0052A, 0053A, 0071A, 0072A, 0073A, 0081A, 0082A, 0091A, 0092A, 0093A, 0111A, 0112A, 0113A, 91300, 91301, 91305, 91306, 91307, 91308, 91309, and 91311. Added 91303, 0031A, and 0034A. Effective 07/01/2023.

06/14/2023 Administrative update. Added 0387U, 0389U, 0390U, 0394U, 0395U, 0398U, 0399U, 0401U, 0791T, 0792T, 0793T, 0794T, 0795T, 0796T, 0797T, 0798T, 0799T, 0800T, 0801T, 0802T, 0803T, 0804T, 0805T, 0806T, 0807T, 0808T, 0810T, C9786, C9787. Effective 07/01/2023.

07/06/2023 Administrative update. Removed 0363U. Added 90380, 90381. Effective 08/01/2023.

08/04/2023 Administrative update. Removed 0354U, 0328U. Added Q0221. Effective 09/01/2023.

09/07/2023 Administrative update. Removed 90678, 90380, 90381. Added 0061U, C9157, 0019M, 0402U, 0404U, 0406U, 0407U, 0412U, 0415U, 0416U, 0418U, A9268, A9269, C9790, C9792. Effective 10/01/2023.

10/05/2023 Administrative update. Removed 0308U, 0309U, 0369U, 0370U, 0371U, 0373U, 0374U, 0399U. Effective 11/01/2023.

10/12/2023 Minor review. Removed CPT codes A4563, 0693T, 0523T, 0353U, 0349U, 0348U, 0347U, 0319U, 0316U, 0323U, 0320U, 0319U, 0316U, 0296U, 0202U, 0164U, 0112U, 0109U, 92519, 92518, 92517, 83529, 81560, 77092, 77091, 77090, 77089.

12/13/2023 Administrative update. Added 0421U, 0422U, 0429U, 0435U, 0814T, 0815T, 0823T, 0824T, 0825T, 0826T, 0857T, 0861T, 0862T, 0863T, 0865T, 0866T, 31242, 31243, 52284, 90589, 90623, 90683, C1600. Deleted 0508T, 0533T, 0534T, 0535T, 0536T, 0768T, 0769T, C7561, C9157, C9788, K1009, 91300, 0001A-0004A, 91305, 0051A-0054A, 91307, 0071A-0074A, 91308, 0081A-0083A, 91301, 0011A-0013A, 91306, 0064A, 91308, 0091A-0094A, 91311, 0111A-0113A, 91303, 0031A, 0034A, 0041A, 0042A, 0044A. Effective 01/01/2024.

03/15/2024 Administrative update. Deleted 0416U. Added 0439U, 0440U, 0441U, 0443U, 0446U, 0447U, A4593, A4594, C9796, E0738, E0739, S9002. Effective 04/01/2024.

04/09/2024 Administrative update. Added 0331T, 0332T. Effective 06/01/2024.

06/05/2024 Administrative update. Added 0660T, 0661T. Removed 90589, 90623. Effective 07/01/2024.

06/10/2024 Administrative update. Deleted codes 03523U, C9787, C9790. Added codes 0020M, 0450U-0452U, 0456U-0458U, 0462U-0464U, 04666U, 0472U, 0867T-0880T, 0882T-0886T, 0888T-0893T, 0897T-0900T, 90637-90638, C1605, J7355. Effective 07/01/2024.

07/08/2024 Administrative update. Removed code 0402U. Effective 08/01/2024.

09/18/2024 Administrative update. New codes 0480U, 0482U, 0483U, 0484U, 0496U, 0500U, 0501U, 0502U, 0504U, 0506U, 0508U, 0509U, 0511U, 0512U, 0517U, 90624, E0715, E0716, E0767, E3200, L8720, L8721, A4544, E0743, 0487U, E0469, A7021 added effective 10/01/2024.

10/16/2024 Minor review. Removed codes 0088U, 0350U, 0377U, 0412U, 0421U, 0422U, 0440T, 0442T, C1600, C1747, C1748, C1749, 90683, 0066U, 0386U, 0416U, 0508T, L8701, L8702.

12/11/2024 Administrative update. Added 0521U, 0522U, 0524U-0526U, 0528U, 0901T-0905T, 0932T, 0935T-0940T, 0946T, 15011-15018, 81558, 82233, 83884, C1735, C1736, C8002, G0561, 0100T, 0472T, 0473T, L8608. Removed 0346U, 0456U, 0553T, 0567T, 0568T, 0616T, C9786, 90683. 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 as this code is now in MP 2.280. Effective 05/01/2025.

03/12/2025 Administrative update. Added codes 0531U, 0532U, 0537U, 0540U, 0541U, 0542U, 0544U, 0545U, 0546U, 0547U, G0566, 33267, 33269, 33370, 0544T, 0345T. Removed 0646T, 0795T-0803T, 0823T-0825T, 0861T-0863T, 0435U, 0019M, 0415U, 0429U, 0285U, J9037, M0222, M0223, Q0221, Q0222. Effective 04/01/2025.

05/01/2025 Administrative update. Added codes 87003, 85170, 62292, 27080, 51605, 51020, 52250, 30210, 15920, 55705, 37650, 85547, 55720, 55725, 43754, 82965, 64818, 64809, 64746, 58400, 58410, S9025, M0075, P2028, P2029, J3570, S3904, P2038, E0350, E0352, P2033. Effective 06/01/2025.

06/02/2025 Administrative update. Added code 94690. Effective 09/01/2025.

06/10/2025 Administrative update. Removing the Benefit Variations and updating the Disclaimer.

06/10/2025 Administrative update. Added codes C1604, 0558U, 0559U, 0563U, 0564U, 0570U, 0573U, 0951T-0960T, 0962T, 0967T-0983T, 90382, 90612, 90613.

07/15/2025 Minor review. No changes to policy statement.

09/09/2025 Administrative update. Added codes A2036, A2037, A2038, A2039, Q4383, Q4384, Q4385, Q4386, Q4393, Q4394, Q4387, Q4388, Q4389, Q4390, Q4391, Q4392, Q4395, Q4396, Q4397, 0577U, 0579U, 0580U, 0581U, 0587U, 0588U, 0589U, 0590U, 0591U, 0593U, 0599U, 290U. Deleted 0450U, 0451U, E0716. Effective 10/01/2025.

11/07/2025 Administrative update. Removed code 90382. Effective 12/01/2025.

12/12/2025 Administrative update. Deleted 0361U, 0508U, 0509U, 0544U, 0619T, 0624T. Added A2008, A2019, 0601U, 0604U, 0607U, 0608U, 0990T, 0991T, 0992T, 0993T, 0994T, 0995T, 0997T, 0998T, 0999T, 1000T, 1001T, 1002T, 1004T, 1006T, 1007T, 1008T, 1009T, 1013T, 1014T, 1015T, 1016T, 1017T, 1018T, 1020T, 1025T, 52443, 75577, 90631, 0376U, 0478U, E0446, 93025, A4638. Effective 01/01/2026.

02/03/2026 Administrative update. Added 31660, 31661, 51020. Removed 0590U, 0593U, 0707T. Effective 03/01/2026.

03/09/2026 Administrative update. Added 77089-77092, 0615U-0617U, 0620U, 0623U-0626U, 0628U-0630U, 0618U, 0619U, G0680, A9294, A8005, A8006, C8010. Removed 83884, 0338T, 0339T, C1735, C1736. Effective 04/01/2026.

04/22/2026 Administrative update. Removed 90624. Effective 05/01/2026.

02/24/2026 Minor review. Removed codes 82965, 83884, 85170, 85547, 87003, 87467, 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, 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, 0558U, 0559U, 0563U, 0564U, 0570U, 0573U, 0577U, 0579U, 0580U, 0581U, 0587U-0591U, 0593U, 0599U, 0601U, 0604U, 0607U, 0608U, 0794T, A2036, A2037, A2038, A2039, Q4383-Q4397, 0338T, 0339T, C1735, C1736, 0707T, 0739T, 0804T, 0889T-0892T, P2028, P2029, P2031, P2033.

06/05/2026 Administrative update. Added codes 1027T-1043T, 1050T-1053T, 90616, 90639. Effective 07/01/2026.

07/13/2026 Administrative update. Added codes C8001, C9793. Effective 08/01/2026.

08/31/2026 Administrative update. Added codes 53860 and 0672T. Effective 09/01/2026.

09/04/2026 Administrative update. Added codes 0950T, 1054T, 1055T, 1057T, 1058T, 1059T, 1060T, 1061T, 1065T, 1066T, 1067T, 1068T, 1069T, 1070T, 1071T, 1080T, 1083T, 1085T, 1087T, 1089T, 1090T, 1091T, 1096T, 1098T, 1099T, 1100T, 1101T, 1102T, 1103T, 1104T, 1105T, 1108T, 1109T, 1110T, 1111T, A6614, E2403. Removed codes 90616 and 90639. Effective 10/01/2026.

10/05/2026 Administrative update. Removed codes 0951T-0955T. Effective 11/01/2026.