CurrentArizona Complete HealthPolicy CP.MP.36

Clinical Policy: Experimental Technologies

Guidelines for evaluating coverage determinations of medical and behavioral health technologies considered experimental or investigational for Arizona Complete Health members; applies when no other policy or coverage statement exists.

Policy Summary

PayerArizona Complete Health

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP.MP.36

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionRequest case-by-case prior authorization demonstrating the medical necessity criteria in I.B and exhaustion of established alternatives when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10medical necessity criteria points (I.B.1-10)

2study requirement (minimum peer-reviewed studies)

case-by-casecoverage determination approach

no-other-policyusage note

Coverage Determination Criteria

COVERAGE CRITERIA

Policy Summary

PayerArizona Complete Health

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP.MP.36

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionRequest case-by-case prior authorization demonstrating the medical necessity criteria in I.B and exhaustion of established alternatives when applicable.

SourceLink

On This Page

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I.A - Technology considered experimental/investigational if ANY of the following apply

I.A.1
- a: Clinical efficacy
- b: Therapeutic value or beneficial effects on health outcomes
- c: Benefits beyond any established medical based alternatives
I.A.2: The most recent peer-reviewed scientific studies published or accepted for publication by nationally recognized medical journals do not conclude, or are inconclusive in findings, that the service is safe and effective for the treatment of the condition for which authorization is requested.

I.B - Medical necessity evaluation (ALL must be considered)

I.B.1: The technology should have final approval from appropriate governmental regulatory bodies when applicable; the indication under review need not match the approved indication.
I.B.2: At least two studies published in peer-reviewed medical literature should be available supporting conclusions regarding effect and likely net health impact; such studies must be well-designed, well-conducted, and yield quality, consistent results.>=2 studies
I.B.3: The health benefits of the technology must outweigh any harmful effects or risks to the member/enrollee.
I.B.4: Other established treatment alternatives should have been exhausted and failed, or no established treatment exists.

Provider Requirements and Actions

Prior Authorization

Case-by-case prior authorization

Coverage determinations for technologies that are or may be considered experimental or investigational must be made on a case-by-case basis by a physician or delegated reviewer and in accordance with the member's Benefit Plan Contract and applicable state and federal requirements. The requested technology must meet the policy's evaluation criteria (regulatory approval when applicable; at least two well‑designed, peer‑reviewed studies supporting efficacy; favorable benefit-risk profile; and other supporting evidence).

Case-by-case review required — decisions made by a physician or ad hoc committee
Evaluate regulatory approval when applicable (e.g., FDA or other competent authority)
Require at least two well‑designed, peer‑reviewed studies demonstrating effect and likely net health impact
Consider opinions from recognized medical associations, consensus panels, and technology-evaluation bodies according to evidence quality
Assess benefit versus risk and whether established alternatives have been exhausted or none exist
Ensure results are generalizable to practice (attainable outside the control setting) and that diagnostic procedures would alter care
Confirm informed consent and that the technology is appropriate to the diagnosis and level of care

Prior Authorization

Exhaust established alternatives

Expect that established treatment alternatives have been exhausted and failed, or document that no established alternative exists, before approving an experimental or investigational technology.

Document prior therapies and outcomes showing exhaustion/ failure of alternatives, or provide rationale for lack of alternatives

Documentation Required

Documentation expectations

Case documentation must demonstrate regulatory approval when applicable, provide at least two well‑designed peer‑reviewed studies supporting efficacy and net health impact, and include other supporting materials such as evaluations from recognized specialty bodies or technology assessment organizations.

Provide copies or citations of FDA or other regulatory approvals (if applicable)
Include at least two high-quality peer‑reviewed studies with methodology and results
Supply relevant expert opinions, consensus statements, or technology assessments and explain their relevance

Denial Risk

Plan-level refusal/denial risk

The Plan may refuse coverage of an experimental or investigational technology if the member's benefit plan does not require coverage for such technologies or if the technology is deemed investigational under this policy. Approval for one case does not guarantee coverage for other cases.

Plan-level refusal/denial risk if technology is investigational or not included in the member's benefit plan
Approval is case-specific and does not establish ongoing coverage obligations
When approved, take steps to use participating or in‑state providers where possible

Background and Scope

The purpose of this policy is to provide a structured set of criteria to guide evaluation of medical necessity for technologies that are or may be experimental or investigational. It instructs reviewers to consider whether a technology is actively under credible evaluation (for example, clinical trials) or whether peer‑reviewed evidence is inconclusive, and to apply a case‑by‑case medical necessity assessment that weighs regulatory approval, available peer‑reviewed studies, benefit versus risk, exhaustion of established alternatives, anticipated real‑world improvement, informed consent, relevance to the diagnosis, and the appropriate level of care. When medical necessity is confirmed, the policy advises furnishing the technology through a participating or in‑state provider when possible.

Key Definitions

Experimental or investigational technology — definition

DefinitionA technology (drug, procedure, device, service, or supply) that is the subject of active and credible evaluation (e.g., clinical trials or research) to determine clinical efficacy, therapeutic value, or benefits beyond established alternatives, or for which peer-reviewed studies are inconclusive regarding safety and effectiveness.

Examples of technology typesDrugs, procedures, devices, services, or supplies.

Evaluation triggerCurrently the subject of active and credible evaluation such as clinical trials or research to determine clinical efficacy, therapeutic value, or benefits beyond established alternatives.

Insufficient evidenceWhen the most recent peer-reviewed scientific studies do not conclude, or are inconclusive, that the service is safe and effective for the requested condition.

Regulatory statusMay include technologies with or without final governmental regulatory approval; approval status is considered during medical necessity review.