CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Experimental / Investigational Treatment Coverage

Defines Neighborhood Health Plan of Rhode Island's criteria and processes for determining coverage of treatments considered experimental or investigational across its lines of business; affects providers requesting authorization and members in the listed products.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyExperimental / Investigational Treatment Coverage

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 28, 2014

Next Review DateApr 9, 2025

Key ActionProviders must submit authorization requests using the payer's access authorization request forms available on the Provider Resources > Forms page or call 1-800-963-1001 for assistance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Annualpolicy reviewed annually

Multiple productslines of business listed as covered

CMS guidanceMedicare Advantage follows CMS guidance

Auth reqauthorization required

Coverage Criteria and Medical Necessity

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medical Necessity Criteria

Covered only when ALL of the following are met (medical necessity criteria used to determine if the requested treatment is not experimental/investigational):

Regulatory/Guidance: Where applicable, the treatment must have final approval from the appropriate governmental bodies or meet applicable CMS guidance for Medicare Advantage members.

CMS guidance is applied for Medicare Advantage; in absence of CMS guidance, EOHHS, peer-reviewed evidence, InterQual, or internal CMPs may be used.

Published 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.

Evidence must demonstrate that the treatment improves health outcomes and that benefits are attainable outside controlled investigational settings.

Comparative Benefit: Available evidence must support that the treatment is as beneficial as established alternatives, or more beneficial for an identifiable subgroup; if less safe but efficacious for patients not adequately treated by existing alternatives, other criteria still must be met.

The available evidence must show that benefits outweigh risks.

Clinical Trial Participation: For cancer or life‑threatening disease, participation in legitimate clinical trials is allowed provided Institutional Review Board approval and informed consent are obtained.

Payer will follow Medicare guidance regarding trial‑related items and will not duplicate coverage for items paid by the trial; lodging and transportation are excluded.

Coverage applies only to services identified as covered benefits under the member's plan. Services that are not identified as covered benefits, or those specifically excluded (for example, Extended Family Planning), will not be covered by Neighborhood Health Plan of Rhode Island. This policy and its criteria apply across Neighborhood's lines of business unless a specific product or regulatory program (for example, Medicare Advantage) imposes different requirements.

Neighborhood will not authorize treatments that are unsupported by legitimate scientific evidence. Services, supplies, devices, procedures, or drugs determined upon review to lack adequate scientific support or to be experimental/investigational are considered not medically necessary and are not authorized for coverage.

Provider Requirements and Authorization

Prior Authorization

Prior authorization required for experimental or investigational treatments

Experimental, investigational, or non‑established treatments require prior authorization and a medical‑necessity review; use the payer's authorization forms and the Authorization Quick Reference Guide for coding guidance.

Step Therapy

Evidence must show benefit versus established alternatives

If less risky or established alternatives exist, the available evidence must show the requested treatment is at least as beneficial as established alternatives or more beneficial for an identifiable subgroup; approval may be denied if alternatives are preferred.

Note

How to request authorization

Submit authorization requests using the payer's access authorization request forms available on the Provider Resources > Forms page; assistance is available by phone at 1-800-963-1001.

Providers > Provider Resources > Forms on the payer website
Phone assistance: 1-800-963-1001

Denial Risk

Denial triggers for unsupported or experimental treatments

Treatments that are unsupported by legitimate scientific evidence or determined to be experimental/investigational upon review will not be authorized.

Background and Scope

Neighborhood evaluates a broad range of interventions — including medications, procedures, devices, diagnostics, supplies, services, facilities, and clinical protocols — to determine whether a requested treatment is experimental or investigational. The review uses multiple factors: regulatory status (final approval by appropriate governmental bodies where applicable or applicable CMS guidance for Medicare Advantage), publication of results in peer‑reviewed medical journals that permit reliable conclusions about health outcomes, and comparative evidence showing benefit relative to established alternatives or for a clearly defined subgroup.

For cancer and other life‑threatening diseases, members may participate in legitimate clinical trials provided the trial has Institutional Review Board approval and appropriate informed consent; Neighborhood will follow Medicare guidance regarding trial‑related items not paid by the trial and will not duplicate coverage for items the trial covers. For non–life‑threatening conditions, supplies or services that have not been recognized as effective in clinical medicine require prior authorization and review by the payer's clinical process, and may be handled by issuance or modification of a Clinical Management Protocol (CMP).

Definitions

Experimental / Investigational

DefinitionServices not recognized as proven effective in clinical medicine; treatment that lacks FDA or appropriate governmental approval for the intended use, lacks endorsement from credible scientific evaluative organizations, or is not being evaluated in appropriate phase II/III clinical trials.

Evidence sources that establish non-experimental statusApproval by FDA or appropriate governmental body for the intended use; endorsement by credible scientific evaluative organizations (e.g., Cochrane Review, UpToDate, medical textbooks, or guideline endorsed by a governmental agency); evaluation in phase II or III clinical trials for the indication considered.

ConsequencesTreatments not meeting the above criteria may be subject to review, prior authorization, and may be determined to be not covered as experimental/investigational.

Life‑threatening disease

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

Clinical trial participationMembers with cancer or life‑threatening diseases are not restricted from participating in legitimate clinical trials provided the trial has IRB approval and informed consent is obtained.

Payer guidanceNeighborhood will follow current Medicare guidelines regarding coverage for trial‑related items not covered by the trial; lodging, transportation, and expenses covered by the clinical trial are excluded from payer coverage.

Treatment (scope)

Scope of 'treatment'The term 'treatment' applies broadly to medications, procedures, devices, diagnostic modalities, supplies, services, facilities, and protocols.

Applications consideredIncludes new technologies and new applications of existing technology when evaluating coverage determinations.

Evaluation contextNeighborhood evaluates whether a medication, procedure, device, diagnostic modality, supply, service, facility, or protocol is experimental/investigational when determining coverage and prior authorization requirements.