CurrentMass General Brigham Health PlanPolicy 021

Experimental and Investigational Treatments

Guidelines Mass General Brigham Health Plan uses to determine when treatments (services, procedures, devices, biologic products, or drugs) are considered experimental or investigational and thus not covered; applies to Mass General Brigham Health Plan members across lines described in the document.

Policy Summary

PayerMass General Brigham Health Plan

PolicyExperimental and Investigational Treatments

Policy CodePolicy 021

Change TypeNo material changes indicated

Effective DateN/A

Next Review DateN/A

Key ActionClaims submitted with codes listed as investigational/unproven will be denied; prior authorization will not make those services payable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

021identifier

~200+investigational codes listed

6evidence levels

chunks 18-37document window

Multipleclinical domains

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Commercial Coverage Criteria

Covered only when ALL of the following are met:

Commercial Coverage Requirements: (1) Final approval from the appropriate government regulatory body (e.g., FDA); (2) Scientific evidence demonstrates conclusions based on sound study methodology published in credible, peer‑reviewed English‑language journals using the hierarchy of evidence: a) systematic reviews/meta‑analyses, b) technology assessments, c) randomized controlled trials, d) cohort studies, e) case‑control studies, f) expert opinion when definitive data are absent; (3) Treatment proven to be safe and effective: beneficial effects outweigh harms, outcomes superior or comparable to established alternatives, improvements realizable outside investigational settings, and cost‑effectiveness comparable to established treatments.

From commercial and qualified health plans guidance (Mass General Brigham Health Plan).

Medicare / One Care / SCO Criteria

For Medicare-related lines, CMS coverage policy governs; when absent, plan policies apply:

Medicare Guidance: Services must (1) fall within at least one benefit category in Section 1861 of the Social Security Act; (2) not be specifically excluded by the Act; and (3) be ‘reasonable and necessary’ per Section 1862(a)(1)(A). National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and Medicare manuals are the primary sources. When CMS guidance is absent, Mass General Brigham Health Plan medical policies are used to determine reasonableness and necessity.

Apply CMS guidance first; when no CMS guidance, follow plan then MassHealth (per One Care/SCO rules).

ACO Criteria

For ACO members:

ACO Guidance: Use MassHealth guidance for medical necessity determinations for Mass General Brigham ACO members; when MassHealth guidance is not available for the requested service, use Mass General Brigham Health Plan medical policies.

ACO‑specific determination flow per plan guidance.

No benefits or reimbursement are provided for health care charges that Mass General Brigham Health Plan considers experimental or investigational. Services, procedures, devices, biologic products, tests, or drugs meeting the plan's definition of experimental/investigational are excluded from coverage and are not payable under member benefits.

The codes enumerated in this policy are explicitly identified as investigational and unproven and therefore are not covered. Examples in this section include CPT codes such as 15011–15013, 15014–15018, 20560–20561, 22526–22527, 22860, 22867–22870, 27278, 30468–30469, 31242–31243, and others listed in the cited entries; use of these codes will be treated as noncovered.

Services and diagnostic tests represented by the listed codes are designated investigational/unproven and are not covered. This includes, for example, procedures and tests such as 0100T (retinal prosthesis implantation), 0101T–0102T (high-energy extracorporeal shock wave procedures), quantitative sensory testing (0106T–0110T series), and numerous other procedure and laboratory codes shown in these policy excerpts.

All codes listed in these sections are classified as investigational and unproven and therefore not covered. Examples include percutaneous laminotomy/laminectomy codes (0274T, 0275T), transcutaneous electrical modulation pain reprocessing (0278T), and multiple Category III and CPT codes enumerated in the referenced lists.

All listed procedure codes in these excerpts are categorized as investigational and unproven and are not payable. The policy specifically lists many CPT and Category III (T‑series) procedure codes (for example, 0505T–0513T, 0666T–0674T among others) that will be treated as noncovered when billed.

All procedures described by the listed Category III (T‑series) codes in these excerpts are considered investigational and unproven and therefore not covered. Examples include T‑series entries such as 0666T–0674T, 0683T–0693T, 0710T–0745T, and 0802T–0814T as shown in the cited sections.

All listed procedure, supply, and device codes in these policy excerpts are considered investigational and unproven and therefore not covered. This includes extensive lists of T‑series, C‑codes, A‑ and E‑codes, and device HCPCS entries shown in the cited chunks (for example, 0802T–0831T, A2001–A2035, C1600–C1834, and related device entries).

The codes, devices, and named tests/products listed in these sections are explicitly stated as investigational and unproven and therefore not covered. Examples include investigational C‑codes such as C9766–C9774, device and therapy listings (e.g., CARTIVA®, Cefaly, Cranial electrotherapy stimulation), and a range of Q‑codes and proprietary wound/allograft products shown in the cited material.

The Q‑codes, S‑codes, and other named therapies appearing in these excerpts are designated investigational and unproven and therefore not covered. Examples include multiple Q‑codes for wound and allograft products (e.g., Q4285–Q4310), S‑codes and service entries such as S8948 (Low Level Laser Therapy), S3722 (AUC analysis for 5‑FU), and named items like the PortableConnect Device and robotic laser treatments referenced in the cited chunks.

The CPT codes shown in these sections are labeled investigational and unproven and therefore are not medically necessary and not covered. Representative entries include codes in the 15000 series (skin cell suspension grafting), spine device codes (22867–22870), selected endoscopic and implantable device codes (31242–31243, 33275–33288), and additional CPT codes enumerated across the cited chunks.

Use of the listed investigational/unproven codes is considered not covered (medically not necessary) by the plan. Prior authorization or submission of documentation will not convert these codes to covered services — the codes listed are excluded because the evidence is insufficient to establish clinical benefit.

The plan's not medically necessary stance applies to all codes enumerated in this section as investigational/unproven. The excerpts list a broad range of laboratory, procedural, device, and Category III codes (for example, 0100T–0110T, 0274T–0278T, 0105U, 0143U–0149U) that are subject to noncoverage on that basis.

Extracorporeal shock wave therapy (ESWT) for foot conditions is explicitly stated as not covered in this policy excerpt; Shock Wave Therapy / ESWT for foot conditions is identified as investigational and unproven and therefore excluded from benefits.

Provider Actions — Billing, Authorization, Documentation

Denial Risk

Denial risk for listed codes

Claims submitted with any of the CPT, Category III, HCPCS, C-, Q-, S- or other codes enumerated in this policy section as investigational or unproven are at risk of denial. Mass General Brigham Health Plan considers these codes investigational/unproven and not covered; prior authorization will not render them payable.

Use of listed investigational/unproven codes may trigger denied coverage.
Prior authorization does not change coverage status for codes explicitly listed as investigational/unproven.
Providers should expect claim denial when billing the codes enumerated in this policy section.

Denial Risk

Claims for listed investigational services

Use of the specific services and devices named in the code lists (examples include Low Level Laser Therapy S8948, PortableConnect Device, Robotic laser treatment for Covid 19 long haulers, and the numerous Q- and S- code products listed) will be considered investigational and not covered. Claims for these services are subject to denial.

Examples of listed investigational services: Low Level Laser Therapy (S8948), Robotic laser treatment for Covid 19 long haulers, ROMTech PortableConnect Device.
The Q- and S- code product lists (see policy code tables) identify additional named devices and products that are investigational and not covered.

Documentation Required

Document code matching

When disputing a denial or validating billing, providers should document the exact code(s) and demonstrate how the billed service maps to the code(s). If the billed service matches any code listed in this policy as investigational/unproven, the claim is not payable.

Document the code(s) billed and include supporting procedure notes to show code-to-service matching.
If the billed code appears in the investigational lists (CPT, Category III, HCPCS, Q-, S-, or C-codes), coverage is not provided regardless of additional documentation.
Providers may identify alternative covered codes or describe medically necessary, evidence-supported treatments when appealing.

0115U	Molecular pathology/proprietary assay (specific description per code)
0116U	Molecular pathology/proprietary assay
0117U	Molecular pathology/proprietary assay
0119U	Molecular pathology/proprietary assay
0120T	Category III / temporary CPT code (specific procedure)
0121U	Molecular pathology/proprietary assay
0122U	Molecular pathology/proprietary assay
0123U	Molecular pathology/proprietary assay
0133T	Category III / temporary CPT code (specific procedure)
0135T	Category III / temporary CPT code (specific procedure)

OpenPayer

Experimental and Investigational Treatments

Coverage Criteria — Experimental & Investigational

Coding — Investigational / Not Covered Codes

Provider Actions — Billing, Authorization, Documentation

Background

Definitions