CurrentCentenePolicy CP MP.36

Clinical Policy: Experimental Technologies

Guidelines for evaluating coverage of technologies (drugs, procedures, devices, services, or supplies) that are or may be experimental or investigational when no other Centene policy applies; applies to health plans affiliated with Centene and governs provider requests for authorization and medical necessity determinations.

Policy Summary

PayerCentene

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP MP.36

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit peer‑reviewed studies and supporting clinical evidence to demonstrate safety, effectiveness, and benefits beyond established alternatives for case‑by‑case review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

10medical necessity criteria points

2+minimum peer‑reviewed studies

case-by-casecoverage determinations

Centene plansapplies to

Coverage Criteria and Determinations

Definition of experimental or investigational (I.A) and medical necessity requirements (I.B)

Coverage determinations consider BOTH of the following groups A and B:

A. Technology status: Technology is currently the subject of active and credible evaluation (e.g., clinical trials or research) to determine therapeutic value, clinical efficacy, and benefits beyond established alternatives; the technology should have final approval from appropriate governmental regulatory bodies when applicable; at least two peer‑reviewed studies should be available to support conclusions.at least 2 studies when applicable

Indication for regulatory approval need not match the requested indication.

B. Medical necessity considerations

B.1: The most recent peer‑reviewed scientific studies do not conclude safety and effectiveness for the requested condition or are inconclusive.

Policy Summary

PayerCentene

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP MP.36

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit peer‑reviewed studies and supporting clinical evidence to demonstrate safety, effectiveness, and benefits beyond established alternatives for case‑by‑case review.

SourceLink

On This Page

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This policy applies to technologies (drugs, procedures, devices, services, or supplies) that are or may be considered experimental or investigational. Coverage is determined in the context of the member's Benefit Plan Contract and applicable state and federal law. Under no circumstances does the policy itself obligate coverage when the Benefit Plan Contract or applicable legal requirements do not require it; the Plan may refuse coverage if the technology is not a benefit under the member's contract. When medical necessity is confirmed under this policy, the service should be furnished by a participating or in‑state provider to the extent possible.

Provider Requirements and Authorization

Prior Authorization

Case-by-case prior authorization

Coverage determinations must be made on a case-by-case basis by a physician or ad hoc committee, in accordance with the member's Benefit Plan Contract and applicable state and federal requirements. The requested technology must be evaluated for clinical efficacy, therapeutic value, and benefits beyond established alternatives.

Step Therapy

Exhaust established alternatives first

Other established treatment alternatives should have been tried and failed, or no established alternative exists, before authorization of an experimental or investigational technology is approved.

Documentation Required

Required supporting documentation

Provide supporting documentation with the authorization request including the most recent peer‑reviewed scientific studies (preferably at least two well‑designed, well‑conducted investigations) and, when applicable, opinions or evaluations from national medical associations, consensus panels, or recognized technology evaluation bodies. Include evidence addressing safety, clinical efficacy, expected net health benefit, and that benefits outweigh risks.

Denial Risk

Grounds for denial

Requests may be denied if the technology is determined to be experimental or investigational. Examples of grounds for denial include, but are not limited to: peer‑reviewed studies are absent, inconclusive, or of insufficient quality to demonstrate safety and efficacy for the requested indication; inadequate evidence that benefits outweigh harms; fewer than the expected number of credible studies supporting net health benefit; or the service is not a covered benefit under the member's Benefit Plan Contract. The Plan may also deny coverage when the technology is not approved by the appropriate governmental regulatory body when such approval is required, or when the requested use is primarily for convenience and not medically necessary.

Background and Purpose

The purpose of this clinical policy is to provide a guide to medical necessity for technologies that are or may be experimental or investigational. It outlines the criteria and process used by the Health Plan to evaluate such technologies and assist in coverage decisions and benefit administration. Coverage determinations are made in accordance with the Benefit Plan Contract, applicable state and federal requirements, and current standards of medical practice; they do not constitute a guarantee of payment or an instruction for clinical care. Where medical necessity is established, steps should be taken to ensure appropriate provision of the technology by a participating or in‑state provider when possible.

Definitions

Experimental or investigational technology — definition

DefinitionA requested technology (drug, procedure, device, service, or supply) that is under active and credible evaluation (e.g., clinical trials or research) and for which peer‑reviewed literature does not conclusively demonstrate safety and effectiveness for the requested indication, or that lacks final regulatory approval when applicable.

Regulatory status requirementThe technology should have final approval from appropriate governmental regulatory bodies when applicable (e.g., FDA); the requested indication need not match the approved indication.

Evidence thresholdAt least two peer‑reviewed studies should be available to support conclusions about the technology's effect and likely net health impact when applicable.

Evaluation scopeActive and credible evaluation includes assessment of therapeutic value, clinical efficacy, and benefits beyond established alternatives.

Medical necessity reviewMedical necessity must be evaluated case‑by‑case considering whether recent peer‑reviewed studies are inconclusive regarding safety/effectiveness, whether benefits outweigh harms, exhaustion of established alternatives, informed consent, and appropriate level of care.

OpenPayer

Clinical Policy: Experimental Technologies

Coverage Criteria and Determinations

Coding and Billing Guidance

Provider Requirements and Authorization

Background and Purpose

Definitions