CurrentCareSourcePolicy N/A

Experimental or Investigational Items or Services

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Defines CareSource's review and coverage stance for items or services considered experimental, investigational, or not medically necessary for Arkansas PASSE members; applies to coverage determinations and review processes for requested treatments.

Policy Summary

PayerCareSource

PolicyExperimental or Investigational Items or Services

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2026

Last ReviewJan 14, 2026

Next Review DateN/A

Key ActionSubmit requests for review; prior authorization will be evaluated and may be denied if the item or service is determined experimental or investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

04/01/2026Policy effective date

Not coveredDeterminations

EPSDT <21EPSDT review

Sources listedEvidence sources

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CurrentCareSourcePolicy N/A

Experimental or Investigational Items or Services

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Sign up for all CareSource policy alerts

Know when CareSource releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerCareSource

PolicyExperimental or Investigational Items or Services

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2026

Last ReviewJan 14, 2026

Next Review DateN/A

Key ActionSubmit requests for review; prior authorization will be evaluated and may be denied if the item or service is determined experimental or investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

04/01/2026Policy effective date

Not coveredDeterminations

EPSDT <21EPSDT review

Sources listedEvidence sources

Definition-based noncoverage

An item or service is considered experimental or investigational when ANY of the following apply; such items/services are not covered unless exceptions apply.

Primary experimental/investigational criteria: Any of: not approved by the United States Food and Drug Administration (FDA) for the proposed use; 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; subject to review and approval by an institutional review board or similar body for the proposed use where final approval has not been granted; the subject of an ongoing Phase 1, 2, or 3 clinical trial; provided as part of a clinical research protocol or clinical trial or otherwise intended to evaluate safety, toxicity, or efficacy; described as experimental or investigational in informed consent documents

If any condition is met, CareSource may deem the item/service experimental or investigational and it is not covered.

Evidence-based noncoverage criteria

CareSource will also consider whether the item/service is supported by credible research; if not, it may be deemed experimental or investigational.

Evidence assessment: Assess whether: scientific evidence is inconclusive concerning the effect on health outcomes; evidence demonstrates improvement in net health outcomes for the total population for whom the item/service might be proposed; evidence shows the item/service is as beneficial as established alternatives for that population; evidence shows benefit under usual conditions of medical practice outside investigational settings

CareSource will consider information from published literature, evaluations by medical associations or technology bodies, FDA and regulatory documents, IRB documents, consent/protocols, medical records, and expert opinions when making this assessment. If evidence fails these assessments, the item/service may be considered investigational.

EPSDT / Pediatric review

EPSDT consideration for members under age 21

EPSDT review: EPSDT does not require coverage of experimental or investigational treatments, services, or items; however, requests for members under age 21 will be reviewed individually to determine medical necessity

Individual review under EPSDT may allow coverage if the item/service is determined medically necessary for the member.

Devices that have received approval under the FDA Humanitarian Use Device (HUD) exemption are explicitly excluded from the definition of experimental or investigational devices and therefore are not considered experimental or investigational for coverage determinations.

Investigational or experimental services are not covered under this policy. This includes, but is not limited to, services or procedures described as investigational, cosmetic, or not medically necessary. CareSource uses these designations to guide medical review and coverage determinations.

Requests for members under age 21 are reviewed individually per EPSDT; EPSDT does not require coverage of experimental or investigational items, but an individualized medical necessity determination will be made for those requests.

Provider Actions, Review, and Documentation Requirements

Prior Authorization

Prior authorization review required

Requests for items or services will be reviewed by CareSource and may be denied if determined experimental or investigational based on the policy criteria.

Submit prior authorization when required by member plan and include supporting clinical documentation to allow evaluation against the policy criteria.

Step Therapy

Comparative evidence considered

CareSource assesses whether evidence shows the item or service is as beneficial as established alternatives; lack of comparative evidence demonstrating comparable benefit may lead to a determination of investigational status.

Review will consider whether evidence demonstrates benefit compared with established alternatives (see policy criteria C.III.C).

Documentation Required

Documentation and evidence considered

CareSource will consider published peer‑reviewed literature, evaluations from medical associations and technology assessment bodies, FDA or other agency documents, IRB documents and study protocols, consent documents, medical records, and expert opinions when reviewing requests.

Published authoritative, peer‑reviewed medical or scientific literature
Evaluations from national medical associations, consensus panels, and technology evaluation bodies
Documents issued by or filed with FDA or other regulatory agencies
Institutional review board documents, study consent/protocols, medical records, and consulting provider opinions

Denial Risk

Denial if determined experimental/investigational

Any health care item or service CareSource determines to be experimental or investigational is not covered.

Coverage denial applies unless an exception in the policy (e.g., Humanitarian Use Device exemption) is explicitly met.

Background

Experimental or investigational items and services encompass a broad range of health care interventions, including medical, surgical, diagnostic, psychiatric, and substance use disorder treatments, as well as devices, drugs, biologics, procedures, and other items that lack FDA approval for the proposed use or are part of clinical research. Items subject to Institutional Review Board (IRB) review without final approval, those that are the subject of ongoing Phase 1–3 clinical trials, provided as part of research protocols, or specifically described as experimental in informed consent documents fall within this category.

When an item or service does not meet the definition-based criteria above, CareSource will also evaluate the strength and quality of supporting evidence. The review considers whether published, authoritative literature and evaluations (for example, national medical associations or technology assessment bodies) demonstrate conclusive benefit, improved net health outcomes in usual practice, and comparable or superior results versus established alternatives. If evidence is lacking or inconclusive, the item or service may be deemed investigational and denied.

Exceptions and special considerations are noted: devices approved under the FDA Humanitarian Use Device exemption are not considered experimental or investigational, and drugs in Phase 4 trials may be covered if they are included on the formulary.

Definitions and Terminology

CPT Category III Codes — definition of temporary codes for emerging technologies, services, and procedures.

DefinitionTemporary (T) codes assigned to emerging technologies, services, and procedures for data collection to support broader adoption or FDA processes.

PurposeUsed to document emerging services and provide data to substantiate more widespread usage or support FDA approval efforts.

ScopeApplies to technologies, services, and procedures that are new or evolving and require tracking before permanent CPT assignment.

Experimental or Investigational Items or Services — definition covering non-FDA-approved uses and items not recognized in authoritative sources.

DefinitionMedical, surgical, diagnostic, psychiatric, substance use disorder treatments, technologies, equipment, supplies, treatments, procedures, therapies, biologics, drugs, or devices that at the time of CareSource coverage determination meet any specified criteria for investigational status.

Key criteria (any apply)Not FDA‑approved for the proposed use; not identified in AHFS or USP Dispensing Information for the proposed use; subject to IRB review without final approval; subject of an ongoing Phase 1–3 clinical trial; provided as part of a clinical research protocol; described as experimental in informed consent documents.

Coverage consequenceAny health care item or service CareSource determines to be experimental or investigational is not covered.

Exceptions — Humanitarian Use Device and Phase 4 trial drug exceptions; describes when such items may not be considered experimental.

Humanitarian Use Device (HUD)Devices that are FDA‑approved under the Humanitarian Use Device exemption are not considered experimental or investigational.

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

Exception effectWhen these exceptions apply, the item/device/drug is not treated as investigational for coverage determinations by CareSource.

Experimental or Investigational Items or Services

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Experimental or Investigational Items or Services

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Coverage Criteria for Experimental or Investigational Items or Services

Referenced Code Sets

Provider Actions, Review, and Documentation Requirements

Background

Definitions and Terminology