CurrentCareSourcePolicy N/A

Experimental or Investigational Items or Services

Defines CareSource's policy for identifying and handling medical items, services, devices, drugs, or procedures deemed experimental or investigational and the coverage implications for members under CareSource plans in Arkansas.

Policy Summary

PayerCareSource

PolicyExperimental or Investigational Items or Services

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit requests for review and any supporting evidence; CareSource will determine coverage based on FDA approval status, standard references, IRB status, and evidence of net health benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance

01/31/2024Policy issue date

03/31/2025Archive date

Coverage Criteria

Not Covered - Experimental/Investigational

Not covered when ANY of the following apply:

Experimental/Investigational Criteria: An item or service is considered experimental or investigational if it is not FDA-approved for the proposed use; not identified in authoritative references (e.g., American Hospital Formulary Service or United States Pharmacopeia Dispensing Information) for the proposed use; subject to institutional review board (IRB) or similar review without final approval; described as experimental in informed consent documents or study protocols; provided as part of a clinical research protocol or trial intended to evaluate safety, toxicity, or efficacy (including Phase 1, 2, or 3 clinical trials); determined by the FDA to be contraindicated for the specific use; or otherwise lacks credible research demonstrating measurable, beneficial health outcomes.

CareSource uses these criteria to deny coverage for experimental/investigational items or services.

Devices that receive FDA approval under the Humanitarian Use Device (HUD) exemption are explicitly excluded from being classified as experimental or investigational under this policy.

Drugs administered as part of Phase 4 clinical trials may be covered when they are included on the plan formulary.

Items and services that are considered investigational, cosmetic, or otherwise not medically necessary are included among those not covered by this policy. CareSource determines whether an item or service meets the policy definition of experimental or investigational by evaluating the available evidence and applicable authoritative sources.

Policy Summary

PayerCareSource

PolicyExperimental or Investigational Items or Services

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit requests for review and any supporting evidence; CareSource will determine coverage based on FDA approval status, standard references, IRB status, and evidence of net health benefit.

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 Actions and Considerations

Prior Authorization

Prior authorization and coverage determination

Items or services may require review; CareSource determines coverage in its sole discretion based on criteria including FDA approval status, presence in standard references, IRB approval status, and evidence of net health benefit.

Step Therapy

Consideration of established alternatives

CareSource may consider whether an item or service has demonstrated benefit compared with established alternatives when making coverage decisions, including whether it is as beneficial as any established alternatives.

Documentation Required

Evidence and documentation considered in reviews

CareSource will consider published peer-reviewed literature, evaluations from national medical associations and technology assessment bodies, FDA and regulatory documents, IRB documents, study consent/protocol documents, and medical records when reviewing requests.

Denial Risk

Denial triggers for experimental/investigational items

Requests for items or services that meet the policy's definition of experimental or investigational (for example, not FDA‑approved for the proposed use; subject to IRB review without final approval; described as experimental in consent or protocol; or part of Phase 1–3 clinical trials) may be denied as not covered.

Background

This policy applies to a broad range of health care items and services — medical, surgical, diagnostic, psychiatric, and substance use disorder treatments — as well as devices, biologics, drugs, procedures, therapies, equipment, and supplies that lack sufficient evidence of net health benefit or are not approved for the proposed use. Any item or service that CareSource, in its sole discretion, deems experimental or investigational is not covered. In making coverage determinations, CareSource considers whether the item or service is identified in authoritative references, whether it is FDA‑approved for the proposed use, whether it is subject to institutional review board oversight without final approval, and whether credible research demonstrates measurable beneficial health outcomes. Devices approved under the Humanitarian Use Device exemption and formulary drugs used in Phase 4 trials are handled as exceptions described elsewhere in this policy.

Definitions

Experimental or Investigational Items or Services — definition details

Definition (short)An item or service is considered experimental or investigational if it is not FDA‑approved for the proposed use; not identified in authoritative references for the proposed use; subject to IRB review without final approval; described as experimental in informed consent or study protocol; part of clinical research protocols or trials intended to evaluate safety/efficacy; or lacks credible research demonstrating measurable beneficial health outcomes.

Not identified in standard referencesNot listed in the American Hospital Formulary Service or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use.

FDA approval statusNot approved by the United States Food and Drug Administration to be lawfully marketed for the proposed use, or determined by the FDA to be contraindicated for the specific use.

IRB/consent statusSubject to review and approval by an institutional review board (or similar body) where final approval has not been granted, or provided pursuant to informed consent documents that describe the item as experimental or investigational.

Clinical trial participationThe subject of an ongoing clinical trial that meets the FDA definition of a Phase 1, 2, or 3 clinical trial, or provided as part of a clinical research protocol intended to evaluate safety, toxicity, or efficacy.

CPT Category III Codes — temporary codes for emerging technologies

DefinitionCPT Category III Codes are a set of temporary (T) codes assigned to emerging technologies, services, and procedures used for data collection to substantiate more widespread usage or to support FDA approval processes.

PurposeIntended primarily for data collection and documentation to support evaluation and potential wider adoption or regulatory review.

Status implicationUse of a Category III code indicates the service or technology is emerging and may lack established evidence of net health benefit.

Humanitarian Use Device exception

Exception statementDevices that are FDA approved under the Humanitarian Use Device exemption are not considered experimental or investigational under this policy.

ScopeApplies to devices approved via the Humanitarian Use Device pathway and excludes them from the policy's experimental/investigational classification.

Coverage implicationSuch Humanitarian Use Devices are therefore not subject to denial on the basis of being experimental or investigational under this policy, though other coverage criteria may still apply.

OpenPayer

Experimental or Investigational Items or Services

Coverage Criteria

Coding

Provider Actions and Considerations

Background

Definitions