CurrentNeighborhood Health Plan of Rhode IslandPolicy 026

Experimental / Investigational Treatments

Defines Neighborhood Health Plan of Rhode Island's coverage stance, criteria, and prior authorization requirements for treatments considered experimental or investigational across product lines and clinical trials; affects providers and members across specified lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyExperimental / Investigational Treatments

Policy CodePolicy 026

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for treatments considered experimental or investigational; requests will be reviewed for medical necessity and may be denied if unsupported by evidence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14document review or revision dates listed

2007-2025creation to latest review

Medicare-alignedMedicare alignment

Listedcovered product lines

Coverage Criteria and Determinations

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Medical Necessity Criteria

Covered or approved when ALL of the following are met (medical necessity determination):

Primary evidence requirements: Treatment must meet at least one of: final approval from the appropriate governmental body (e.g., FDA) for the intended use; deemed effective by a credible scientific evaluative organization (e.g., Cochrane, UpToDate, authoritative guidelines or textbooks); or not presently being evaluated by phase I, II, or III clinical trials for the indication.

derived from Experimental/Investigational definition

Peer-reviewed evidence: Scientific evidence must include publication of results in peer-reviewed medical journals and permit reliable conclusions about the effect of the treatment on health outcomes.

criteria items regarding peer-reviewed evidence and generalizability

Demonstrated benefit: Available evidence must support that the treatment improves health outcomes and is either as beneficial as established alternatives or more beneficial for an identifiable subgroup.

comparative benefit criteria

Safety and comparative risk: Available evidence must support that the treatment is as safe as existing alternatives, or if less safe, that it provides efficacy for patients not adequately treated by existing alternatives and that all other criteria are met.

safety comparison criterion

Benefit–risk and external validity: The benefits must outweigh the risks and be reproducible outside of controlled investigational settings.

external validity and benefit–risk criteria

Clinical Trial Participation (Cancer / Life‑threatening)

Clinical trial participation for cancer or life‑threatening disease is permitted when ALL of the following are true:

Trial eligibility and oversight: Member is an appropriate candidate for the trial; the trial has been approved by the relevant Institutional Review Board; the organization administering the trial is qualified; and the member has given proper informed consent.

trial participant protections and responsibilities

Coverage for trial-related items: Neighborhood will follow current Medicare guidelines for coverage of trial-related items not covered by the trial. Neighborhood excludes lodging, transportation, and expenses covered by the clinical trial and will not provide duplicative coverage for services or drug/device costs paid by the trial.

limits on trial-related coverage and prohibition on duplicate billing

Extended Family Planning (EFP) is an explicit exclusion from coverage. In addition, any treatment that has not been identified as a covered benefit will not be covered.

Neighborhood will not authorize treatments that are unsupported by legitimate scientific evidence. Requests for treatments, procedures, devices, drugs, supplies, facilities, or services that have not been recognized as proven effective require prior authorization and review for medical necessity; if, after review, a treatment is determined to be unsupported by scientific evidence, it will not be authorized.

Provider Actions, Prior Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests involving treatments, procedures, facilities, equipment, drugs, supplies, or services that are considered experimental/investigational or not recognized as proven effective. Requests will be reviewed for medical necessity using the criteria outlined in this policy. If multiple requests for the same experimental service are received, Neighborhood may create a new Clinical Management Policy (CMP) or modify an existing CMP.

Note

Prior Authorization Access and Contact

Providers should submit prior authorization requests using Neighborhood Health Plan of Rhode Island prior authorization request forms available on the payer website. For assistance with forms or submission questions, providers may call Neighborhood's provider line at 1-800-963-1001. Refer to the Authorization Quick Reference Guide for coding information related to covered codes.

Access forms: www.nhpri.org → Providers → Provider Resources → Forms → 'Click here for a list of prior authorization request forms'.
Phone support: 1-800-963-1001

Denial Risk

Denial Triggers

Services determined to be experimental/investigational or unsupported by legitimate scientific evidence will not be authorized. If, upon review, a treatment is judged experimental, approval will only be granted as described in this policy and at Neighborhood's discretion. Treatments that meet medical necessity criteria may be approved by Neighborhood's Medical Director or a physician designee on a case-by-case basis.

Denial triggers include: lack of peer-reviewed evidence, inability to demonstrate improvement in health outcomes, evidence that benefits do not outweigh risks, or failure to show effectiveness outside investigational settings.

Background and Policy Purpose

For the purposes of this policy, experimental/investigational treatments are those not recognized as proven effective in clinical medicine and those that have not been previously evaluated by the Clinical Management Committee. Such requests require prior authorization and a formal medical necessity review. The policy establishes a process whereby treatments that meet medical necessity criteria may receive case-based approval by the Medical Director or physician designee; treatments deemed experimental/investigational may be managed through development or modification of Clinical Management Protocols (CMPs), and those found unsupported by scientific evidence will not be authorized.

Key Definitions

Experimental/Investigational

DefinitionServices not recognized as proven effective in clinical medicine; any treatment that does not meet at least one of the listed conditions may be considered experimental or investigational and subject to review or prior authorization.

Acceptable evidence — FDA/governmentTreatment has been approved by the FDA or appropriate governmental body for the intended use.

Acceptable evidence — evaluative organizationsTreatment has been deemed effective by a credible scientific evaluative organization (e.g., Cochrane review, UpToDate, a medical textbook, or guidelines published/endorsed by a governmental agency).

Exclusion from experimental statusTreatment (for the indication being considered) is not presently being evaluated in a phase I, II, or III clinical trial.

Policy actionSuch services may be subject to review or prior authorization by Neighborhood Health Plan and are evaluated through Neighborhood’s formal evidence review process.

Life‑threatening Disease

DefinitionA disease that is likely to cause death within one year of the request for treatment.

ContextUsed to define eligibility for special provisions such as clinical trial participation for cancer or life‑threatening disease.

Relevance to coverageLife‑threatening designation guides application of trial coverage and consideration of investigational therapies under this policy.

Treatment — definition

ScopeIncludes medications, procedures, devices, diagnostic modalities, supplies, services, facilities, and protocols.

Use in policyThe term 'treatment' is applied throughout the policy to determine whether an item or service is experimental/investigational and subject to review.

Decision implicationAny of these modalities may be evaluated individually for FDA approval, evidence from credible evaluative organizations, or clinical trial status to determine coverage.

OpenPayer

Experimental / Investigational Treatments

Coverage Criteria and Determinations

Coding and Billing

Provider Actions, Prior Authorization, and Denials

Background and Policy Purpose

Key Definitions