CurrentUnitedHealthcarePolicy BIP059.N

Experimental and Investigational Services

Defines UnitedHealthcare's criteria for coverage of services deemed experimental or investigational and the circumstances under which such services may be covered; applies to UnitedHealthcare members and providers governed by the payer's benefit plans.

Policy Summary

PayerUnitedHealthcare

PolicyExperimental and Investigational Services

Policy CodePolicy BIP059.N

Change TypeRoutine reviewclarified archival of prior version

Effective DateJune 1, 2026

Next Review Date

Key ActionObtain prior authorization or a medical director determination when coverage of an experimental or investigational procedure is requested.

SourceLink

POLICY UPDATE CHANGES

Routine review; no change to coverage guidelines

2026-06-01effective date

BIP059.Npolicy identifier

3sections listing covered benefits

1federal/state regulation ref

Coverage Criteria for Experimental and Investigational Services

Policy Summary

PayerUnitedHealthcare

PolicyExperimental and Investigational Services

Policy CodePolicy BIP059.N

Change TypeRoutine reviewclarified archival of prior version

Effective DateJune 1, 2026

Next Review Date

Key ActionObtain prior authorization or a medical director determination when coverage of an experimental or investigational procedure is requested.

SourceLink

On This Page

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_conditions: Mandated by state or federal law (refer to the Federal/State Mandated Regulations and/or State Market Plan Enhancements sections)

Always verify member Evidence of Coverage (EOC) or Schedule of Benefits (SOB) for plan-specific provisions.

coverage_conditions: Determined to be covered by a UnitedHealthcare medical director or designee

Determinations rely on sources such as the member's medical records, treatment protocols, informed consent, published medical/scientific literature, expert medical opinion, agency or review organization opinions, and relevant regulations/documents.

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Medical Director Determination

Prior authorization and/or a medical director determination may be required. Coverage for experimental and/or investigational therapies may be determined by a UnitedHealthcare medical director or designee; refer to the member's Evidence of Coverage (EOC) or Schedule of Benefits (SOB) to determine coverage eligibility.

Decision may be based on member medical records, treatment protocols, informed consent, published literature, expert opinion, and agency/organization opinions (e.g., FDA, ECRI, HAYES, MCMC).
Services mandated by state or federal law are covered when applicable.
If UnitedHealthcare determines a therapy is experimental/investigational, coverage may be denied but the decision can be subject to independent medical review under California HSC §1370.4 when statutory criteria are met.

Prior Authorization

Independent Review Eligibility and Provider Documentation

Independent review eligibility follows California HSC §1370.4. To qualify for external independent review of a denial for an experimental or investigational therapy, all statutory criteria must be met, including that the enrollee has a life‑threatening or seriously debilitating condition and standard therapies have been ineffective, inappropriate, or there is no more beneficial standard therapy covered by the plan.

Enrollee must have a life‑threatening or seriously debilitating condition (see statute for definitions).
Physician certification required that proposed therapy is likely to be more beneficial than available standard therapies, with statement of evidence relied upon.
Enrollee must have been denied coverage by the plan for the recommended therapy, and the therapy would otherwise be a covered service except for the plan's experimental/investigational determination.

Documentation Required

Documentation and Evidence to Submit

UnitedHealthcare relies on the member's medical records, treatment protocols, informed consent, published authoritative medical and scientific literature, expert medical opinion, and opinions of other agencies or review organizations when evaluating experimental or investigational therapies. Providers should supply complete documentation to support medical necessity and the physician's written certification when applicable.

Provide the member's relevant medical records and history.
Include the protocol(s) for the proposed therapy and any informed consent documents.
Attach published medical/scientific evidence and statements from treating physicians describing why the therapy is likely to be more beneficial than standard therapies.

Denial Risk

Denial Risk for Experimental/Investigational Services

Services determined to be experimental and/or investigational that do not meet coverage criteria are not covered and may be denied. Denial decisions may be subject to independent medical review when statutory criteria are satisfied.

If the therapy is not mandated by law and the UnitedHealthcare medical director determines it is experimental/investigational, the service is not covered.
Providers and members may seek independent medical review per state law when the enrollee meets the eligibility criteria in HSC §1370.4.

Note

Independent Medical Review and Appeal Rights

Denials of experimental or investigational therapies may be subject to independent medical review as described by California Health and Safety Code §1370.4 and Article 5.55 (commencing with §1374.30). Providers should follow appeal and independent review procedures in the member's EOC and applicable state regulations.

Ensure physician certification and supporting evidence are included when requesting independent review.
UnitedHealthcare may consider authoritative sources such as FDA actions, ECRI, HAYES, and peer‑reviewed literature when defending a denial.

Background

This policy addresses situations where proposed drugs, devices, procedures, or therapies are considered experimental or investigational and describes the circumstances under which such services may be evaluated for coverage. UnitedHealthcare uses sources such as medical records, treatment protocols, informed consent, published literature, expert opinion, and applicable regulations when making determinations. Services that do not meet the coverage conditions described in this policy are not covered, and members should consult their EOC/SOB for plan-specific provisions and any available appeal or independent review rights.

Key Definitions

Life‑threatening definition

DefinitionLife-threatening: diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, or diseases/conditions with potentially fatal outcomes where the end point of clinical intervention is survival.

Source authorityCalifornia Health and Safety Code Section 1370.4 provides this definition for purposes of independent external review of experimental or investigational therapies.

Context of useUsed to determine eligibility for external independent review when a member has a life‑threatening condition and standard therapies are ineffective, inappropriate, or unavailable.

Relation to coveragePresence of a life‑threatening condition is one criterion that may trigger review of coverage decisions for experimental or investigational therapies under the policy.

Seriously debilitating definition

DefinitionSeriously debilitating: diseases or conditions that cause major irreversible morbidity.

Source authorityDefined in California Health and Safety Code Section 1370.4 for purposes of external independent review of experimental or investigational therapies.

Context of useApplied when assessing eligibility for independent external review if standard therapies have not been effective, are inappropriate, or no more beneficial standard therapy is covered.

Relation to coverageA seriously debilitating condition is a qualifying criterion for consideration of experimental or investigational therapy review under the policy.