CurrentAmbetter NevadaPolicy CP.MP.36

Clinical Policy: Experimental Technologies

Guidelines for evaluating coverage of medical and behavioral health technologies considered experimental or investigational when no other specific policy exists; applies to members/enrollees of Centene-affiliated health plans including Ambetter Nevada.

Policy Summary

PayerAmbetter Nevada

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP.MP.36

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvide at least two peer-reviewed studies, regulatory approvals when applicable, and documentation that established alternatives were exhausted when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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

2+peer-reviewed studies recommended

CP.MP.36policy id

No other policyapplies when

Coverage Criteria for Experimental or Investigational Technologies

inv-01: Medical necessity criteria — Covered when BOTH of the following are met

Covered when BOTH of the following are met

I.A - Experimental/Investigational definition: A technology is requested and is considered experimental or investigational if any of the following apply: 1) it is currently the subject of active and credible evaluation (e.g., clinical trials or research) to determine clinical efficacy, therapeutic value or beneficial effects on health outcomes, or benefits beyond established medical alternatives; 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 criteria

B.1: The technology should have final approval from appropriate governmental regulatory bodies when applicable (e.g., FDA or other relevant authority). The indication under review need not match the approved indication.

Policy Summary

PayerAmbetter Nevada

PolicyClinical Policy: Experimental Technologies

Policy CodePolicy CP.MP.36

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvide at least two peer-reviewed studies, regulatory approvals when applicable, and documentation that established alternatives were exhausted when requesting authorization.

SourceLink

On This Page

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B.2: At least two studies published in peer-reviewed medical literature should be available that support conclusions regarding the effect of the technology and its likely net health impact; such studies must be well-designed, well-conducted, yield quality and consistent results, and demonstrate the effect on the disease, injury, illness, or condition in question.

B.3: The health benefits of the technology must outweigh any harmful effects or risks to the member/enrollee.

B.4: Other established treatment alternatives should have been exhausted and failed, or no established treatment exists.

B.5: Improvement to be gained by employing the technology should be attainable outside the control setting (i.e., in practice).

B.6: For diagnostic procedures, it is anticipated the results will help determine the best plan of care and lead to some potential intervention or alteration to the current plan of care.

B.7: The member/enrollee fully understands the risks and benefits regarding the requested technology or treatment and has given informed consent.

B.8: The technology is consistent with the symptoms or diagnosis of the illness or injury under treatment.

B.9: The technology is not furnished primarily for the convenience of the patient, provider, or supplier.

B.10: The technology is furnished at the most appropriate level of care that can be provided safely and effectively to the patient.

This policy is not an acknowledgement of an obligation to cover experimental or investigational technologies when such coverage is not included in the member's Benefit Plan Contract or not mandated by applicable state or federal requirements. The Plan reserves the right to refuse coverage of an experimental or investigational technology if coverage is not required under the member/enrollee's benefit plan, and approval for one case does not guarantee coverage for other cases.

Technologies that lack adequate peer-reviewed evidence of safety and effectiveness for the requested indication, or for which the most recent peer-reviewed studies are inconclusive, are considered experimental or investigational. Such technologies are generally not supported for coverage unless the requested service meets the policy's medical necessity criteria and is evaluated on a case-by-case basis.

Provider Responsibilities and Authorization Requirements

Prior Authorization

Case-by-case prior authorization

All 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 an ad hoc committee in accordance with the member's Benefit Plan Contract and applicable state and federal requirements.

Documentation Required

Documentation required

Provide supporting evidence when requesting authorization. At minimum, include: (1) at least two well‑designed, peer‑reviewed studies published or accepted for publication in nationally recognized medical journals that support conclusions about the technology's effects and likely net health impact; (2) any applicable final regulatory approvals (e.g., FDA) and the approved indications; and (3) other relevant evidence such as evaluations from national medical associations, consensus panels, or recognized technology assessment organizations. Documentation should demonstrate that established treatment alternatives have been exhausted and failed or that no established treatment exists, that benefits outweigh risks, and that use will meaningfully alter the plan of care when diagnostic.

Denial Risk

Benefit plan / regulatory exclusion

The Plan may refuse coverage of an experimental or investigational technology if the technology is not included in the member's benefit plan or coverage is not required under applicable state or federal law. Approval for one case does not guarantee coverage for other cases.

Background

This policy provides criteria to guide evaluation of the medical necessity of technologies that are or may be considered experimental or investigational. When medical necessity is confirmed, the policy advises furnishing the technology through a participating or in‑state provider to the extent possible. Determinations must be made case-by-case by a physician or ad hoc committee in accordance with the Benefit Plan Contract and applicable state and federal requirements, and the requested technology must meet the policy's definition of experimental/investigational and the specified medical necessity criteria.

Definitions

inv-09: Experimental or investigational

DefinitionA technology is considered experimental or investigational if it 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 if recent peer-reviewed studies do not conclude or are inconclusive that the service is safe and effective for the requested condition.

Required demonstration of safety/effectivenessAt least two studies published in peer-reviewed medical literature should be available that support conclusions regarding the technology's effect and likely net health impact.

Regulatory approval expectationTechnology should have final approval from applicable governmental regulatory bodies (e.g., FDA) when required; the reviewed indication need not match the approved indication.

Case-by-case determinationCoverage determinations must be made on a case-by-case basis by a physician or ad hoc committee in accordance with the Benefit Plan Contract and applicable state and federal requirements.

Clinical trial statusActive and credible evaluation (such as clinical trials or research) of clinical efficacy, therapeutic value, or benefits beyond established alternatives classifies a technology as experimental/investigational.