CurrentCareSourcePolicy N/A

Experimental or Investigational Items or Services

Defines CareSource's determination and coverage stance for items or services considered experimental, investigational, cosmetic, or not medically necessary; applies to CareSource members and providers requesting coverage determinations.

Policy Summary

PayerCareSource

PolicyExperimental or Investigational Items or Services

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization and supporting evidence (literature, FDA/regulatory documents, IRB and study protocols, medical records) when requesting items considered experimental or investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

04/01/2025effective date stated

Archived 03/31/2026archival note

CPT IIIcode guidance

FDA/Trialsregs cited

Coverage criteria — experimental, investigational, cosmetic, not medically necessary

inv-01: Not Covered when Determined Experimental/Investigational

Items or services are not covered when CareSource determines ANY of the following apply:

Experimental or Investigational Determination: Not approved by the United States Food and Drug Administration (FDA) to be lawfully marketed for the proposed use; OR not identified in the American Hospital Formulary Service or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use, or determined by the FDA to be contraindicated for the specific use; OR subject to review and approval by an institutional review board (IRB) or similar body for the proposed use and such final approval has not been granted; OR the subject of an ongoing Phase 1, 2, or 3 clinical trial as defined by FDA regulations; OR provided as part of a clinical research protocol or clinical trial or otherwise intended to evaluate safety, toxicity, or efficacy; OR provided pursuant to informed consent documents that describe the item or service as experimental or investigational or indicate its safety, toxicity, or efficacy is under evaluation.

Based on definitions in Section C (see citations)

inv-02: Additional Evidence-Based Determination

CareSource may also deem an item experimental/investigational based on evidence appraisal:

Policy Summary

PayerCareSource

PolicyExperimental or Investigational Items or Services

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2025

Next Review DateN/A

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider requirements and actions

Prior Authorization

Prior authorization required

Prior authorization is required for requests for items or services that CareSource determines to be experimental or investigational, including emerging technologies identified by CPT Category III codes. Providers must obtain prior authorization before providing such items or services to avoid claim denials.

Includes emerging technologies identified by CPT Category III codes

Prior Authorization

Consideration of established alternatives

CareSource may require documentation that established alternatives were considered and that the requested item or service demonstrably improves patient outcomes compared with those alternatives. Be prepared to provide comparative evidence showing benefit over standard treatments.

Document consideration of established alternatives
Provide evidence of improved outcomes versus alternatives

Documentation Required

Evidence and records required for review

CareSource will evaluate requests using published literature, national evaluations, FDA or other regulatory documents, institutional review board documents, consent forms, study protocols, and medical records. Provide these records with the authorization request to support review.

Published peer-reviewed literature
National medical association and technology evaluations
FDA or other regulatory agency documents
IRB documents, consent forms, study protocols
Relevant medical records

Denial Risk

Denial for experimental/investigational items

Requests determined to be experimental or investigational under CareSource criteria are not covered and may be denied. Providers should obtain prior authorization and submit supporting evidence; absence of credible research demonstrating net health benefit or benefit over established alternatives may lead to denial.

Denial may occur when evidence is inconclusive or does not show net health benefit
Not covered if not shown to be as beneficial as established alternatives

Key definitions

inv-11: Experimental or Investigational Items or Services — key attributes

Definition — FDA approval statusNot approved by the U.S. FDA to be lawfully marketed for the proposed use constitutes experimental or investigational.

Formulary supportNot identified in AHFS or USP Dispensing Information for the proposed use, or determined by the FDA to be contraindicated for that use, supports an experimental/investigational determination.

IRB involvementSubject to review and approval by an institutional review board (or similar body) for the proposed use, where final approval has not been granted, is considered experimental/investigational.

Clinical trial statusThe subject of an ongoing Phase 1, 2, or 3 clinical trial (per FDA definitions) is considered experimental/investigational, regardless of FDA oversight.

Research protocol or consent languageProvided as part of a clinical research protocol or pursuant to informed consent documents that describe the item or service as experimental or investigational qualifies it as such.

inv-12: CPT Category III Codes — temporary codes for emerging technologies, data collection, and regulatory support

DefinitionTemporary (T) CPT Category III codes are assigned to emerging technologies, services, and procedures for data collection to support wider usage or FDA approval processes.

PurposeIntended to be used for data collection to substantiate more widespread usage or to provide documentation for the FDA approval process.

StatusCategory III codes indicate emerging technologies and do not by themselves establish medical necessity or routine coverage.

inv-13: Exceptions — Devices FDA-approved under the Humanitarian Use Device exemption and other exceptions (Phase 4 drug trials) noted

Humanitarian Use Device (HUD) exemptionDevices FDA-approved under the Humanitarian Use Device exemption are not considered experimental or investigational.

Phase 4 drugsDrugs used in Phase 4 trials may be covered if they are part of the formulary.

Scope of exceptionThe HUD exemption applies despite the device otherwise meeting criteria for experimental/investigational status under the policy definitions.

OpenPayer

Experimental or Investigational Items or Services

Coverage criteria — experimental, investigational, cosmetic, not medically necessary

Coding guidance and code lists

Provider requirements and actions

Background

Key definitions