CurrentIndependent HealthPolicy M20150623055

Experimental or Investigational Treatment Utilization Review Decisions

Governs coverage determinations and authorization requirements for treatments, tests, devices, drugs, or interventions considered experimental, investigational, or unproven for Independent Health members across multiple lines of business.

Policy Summary

PayerIndependent Health

PolicyExperimental or Investigational Treatment Utilization Review Decisions

Policy CodePolicy M20150623055

Change TypeFormatting and minor revisions (2023-2025)

Effective Date1/1/1984

Next Review Date

Key ActionObtain prior authorization for experimental, investigational, or unproven treatments; provide supporting evidence including peer‑reviewed literature and regulatory status for review by an Independent Health medical director.

SourceLink

POLICY UPDATE CHANGES

Revised - Formatting changes only.

Policy revised on multiple dates (2023-2025) per version control.

Multi-lineLines of business

Pre-authorization requiredAuthorization requirement

1 referencedRelated policies

M20150623055Policy ID

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.

Coverage Criteria

Coverage criteria (medical necessity)

Covered when ALL of the following are met:

Regulatory approval: The requested service (medical device, drug, or biological product) must have received final approval from appropriate regulatory agencies (e.g., FDA). Interim approvals (e.g., an Investigational Device Exemption) are not automatically sufficient.final approval required

Regulatory approval will be considered but does not alone establish proven benefit for a specific diagnosis.

Published Evidence — defined positive effect: Published peer-reviewed medical literature must demonstrate that the service has a defined, positive effect on health outcomes from well-designed studies with positive endorsements from national medical professional organizations or boards regarding scientific efficacy and rationale.conclusive peer-reviewed evidence

Evidence sources may include current scientific literature, Hayes Knowledge Center, UpToDate, professional society guidance, and clinical practice guidelines.

Published Evidence — benefit outweighs harm: Published peer-reviewed literature must show the service leads to improvements in health outcomes with the beneficial effects outweighing any harmful effects.benefit outweighs harm

Independent Health will evaluate safety and comparative effectiveness in the literature.

Published Evidence — comparative effectiveness: Published peer-reviewed literature must show the service is at least as effective in improving health outcomes as established services or technologies, or is usable in appropriate clinical contexts where an established service or technology is not employable.>= established services or suitable when established services cannot be used

Comparative effectiveness is assessed relative to established treatments.

Generalizability to Standard Practice: Published evidence must demonstrate that improvement in health outcomes is possible in standard conditions of medical practice outside investigational or clinical trial settings.applicable in standard practice

Services that are solely effective within investigational settings do not meet this criterion.

Any service that is related to a corresponding experimental service is not covered in addition to the experimental service; this includes, but is not limited to, insertion of medications, monitors, or medical devices. Independent Health does not cover requests for experimental or investigational treatments that are not part of an approved study or that fall outside accepted standards of medical care.

Coverage for an experimental, investigational, or unproven treatment may be considered only when the request meets the policy’s medical necessity requirements and is reviewed on an individual case basis by an Independent Health medical director.

Requests for experimental or investigational treatments that are not currently part of an approved study, or that are outside accepted standards of medical care, are listed as not covered. Such requests may be denied and are subject to the plan’s authorization requirements.

Pre-authorization is required for experimental, investigational, or unproven treatments and will be reviewed individually; when commonly accepted medical procedures have proven unsuccessful or are known to be harmful or ineffective for the member, authorization may be considered if supporting evidence is provided.

Provider Actions & Authorization

Prior Authorization

Pre-authorization required

Pre-authorization is required for requests for experimental, investigational, or unproven treatments; each request will be reviewed on an individual case basis by Independent Health.

Step Therapy

Must show standard therapies are inadequate

Authorization may be considered only when commonly accepted medical procedures have proven unsuccessful or are known to be harmful or ineffective for the individual; the provider must show that established therapies are unsuitable for the member.

Documentation Required

Provide evidence and supporting documentation

Requests will be reviewed by an Independent Health medical director using supporting peer‑reviewed literature, regulatory status (e.g., FDA approval), clinical practice guidelines, and expert input; submit documentation demonstrating efficacy, safety, and comparative effectiveness.

Denial Risk

Non‑covered: experimental/investigational outside approved studies

Requests for experimental or investigational treatment that are not part of an approved study or not within accepted standards of medical care are not covered and may be denied.

Definitions

inv-09: Experimental Services — definition and criteria (FDA approval / formulary status)

DefinitionNot approved by the U.S. Food and Drug Administration (FDA) to be lawfully marketed for the proposed use or not identified in the American Hospital Formulary Service as appropriate for the proposed use.

Coverage implicationServices meeting this definition are considered experimental and require pre-authorization; they are not covered if not in an approved study or not within accepted standards of care.

Regulatory statusFinal FDA approval and formulary identification are required to consider the service non-experimental.

Related exclusionsAny service related to a corresponding experimental service would not be covered in addition to the experimental service.

inv-10: Investigational Services — definition referencing clinical trial phases (FDA Phase I–III)

DefinitionThe subject of an ongoing clinical trial that meets the definition of a Phase I, II, or III clinical trial set forth in the FDA regulation, regardless of whether the trial is subject to FDA oversight.

Phases referencedIncludes FDA Phase I–III clinical trials definitions.

Coverage considerationServices that are investigational (trial subjects) are reviewed under policy and require pre-authorization; coverage depends on trial status and evidence.

Regulatory oversightApplies regardless of whether the clinical trial is under FDA oversight.

inv-11: Unproven Services — definition about lack of consistent evidence in peer-reviewed literature

DefinitionServices which, regardless of approval by the appropriate governmental regulatory body, are not consistent with conclusions of published, peer-reviewed literature demonstrating equivalent or superior beneficial effect on health outcomes compared to established treatments or technologies.

Evidence standardsRequires well-conducted randomized placebo-controlled trials or well-conducted cohort studies with sufficient sample size and power to draw clinically significant conclusions.

Safety requirementMust demonstrate an equivalent or superior safety profile compared to established treatments and technologies.

Implication for approvalRegulatory approval alone does not exempt a service from being considered unproven; adequate, consistent peer-reviewed evidence is required.

Revision History

2025-11-01formatting updateLatest

Policy revised — formatting changes only (version control entry).

2024-11-01revision

Policy revised (version control entry).

2024-08-01revision

Policy revised (version control entry).

2024-01-01revision

Policy revised (version control entry).

2023-10-01revision

Policy revised (version control entry).

2021-11-01revision

Policy reviewed/revised (version control entry).

2020-10-01review

Policy reviewed (version control entry).

2019-11-01revision

Policy reviewed/revised (version control entry).

2018-11-01review

Policy reviewed (version control entry).

2017-11-01review

Policy reviewed (version control entry).

2016-12-01revision

Policy reviewed/revised (version control entry).

2016-10-01revision

Policy reviewed/revised (version control entry).

2015-09-01review

Policy reviewed (former policy number M840101081 noted).

OpenPayer

Experimental or Investigational Treatment Utilization Review Decisions

Coverage Criteria

Provider Actions & Authorization

Background

Definitions

Revision History