Sierra Health and Life clinical trials Coverage Update

Coverage Criteria for Clinical Trials

Coverage of Routine Patient Costs for Qualifying Clinical Trials

Covered when ALL of the following are met:

Qualification: Member is a qualified individual covered under the health plan and eligible to participate in an Approved Clinical Trial per the trial protocol (either referred by an in-network health care professional or provides medical/scientific information establishing eligibility).

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Approved Clinical Trial: The Clinical Trial is Phase I, II, III, or IV and is related to prevention, detection, or treatment of cancer or another life‑threatening disease or condition, and meets the Criteria for Approved Clinical Trials (e.g., approved/funded by specified federal agencies, conducted under an FDA investigational new drug application, or otherwise meets listed criteria).

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Covered Services: Routine patient costs are covered when they are services for which benefits are typically provided absent a Clinical Trial; required solely for provision of the investigational item/service; required for clinically appropriate monitoring of effects of the investigational item/service; or needed to prevent or treat complications arising from the investigational item/service.

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Protocol and IRB requirements: The Clinical Trial must have a written protocol describing a scientifically sound study approved by all relevant institutional review boards; UnitedHealthcare may request trial documentation at any time.

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Coverage Criteria and Exceptions

Covered when ALL of the following are met (exceptions and special consideration):

Clinical trial exceptions: Clinical Trials that meet the Coverage Rationale in Section 1 are exceptions to the Experimental/Investigational exclusion and may have benefits available as described under Clinical Trials in Section 1: Covered Health Care Services.

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Special consideration for otherwise Experimental/Investigational services: If the member is not participating in a qualifying Clinical Trial and has a sickness or condition likely to cause death within one year of the treatment request, UnitedHealthcare may consider an otherwise Experimental or Investigational Service to be a Covered Health Care Service only after determining there is sufficient evidence that the service has significant potential as an effective treatment.member life expectancy <= 1 year

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Benefit determination: Final determination of benefit coverage is governed by the member-specific benefit plan document; most plans include coverage for Clinical Trials that meet the Coverage Rationale but member-specific documents control.

Excluded from benefits is the experimental or investigational item or service itself. Limited exceptions apply for certain FDA-designated Category B devices when all specified conditions are met (device used within an FDA‑Approved Clinical Trial and per protocol, falls under a covered benefit category, medically necessary for the member, appropriate setting, and appropriate amount/duration/frequency). Also excluded are items and services provided solely to satisfy data collection and analysis (not used in direct clinical management), services clearly inconsistent with accepted standards of care, items provided free by research sponsors, travel and transportation, lodging and meals, routine patient costs obtained out-of-network where no non-network benefits exist, and clinical trials that do not meet the Indications for Coverage.

An Experimental or Investigational Service includes services, technologies, drugs, devices, procedures, or supplies that at the time of coverage determination are: not FDA‑approved for the proposed use and not supported by the listed compendia (AHFS DI, Clinical Pharmacology, DRUGDEX) or NCCN categories; the subject of ongoing Phase I–III trials; only obtainable, with regard to outcomes for the given indication, within research settings; or otherwise determined by UnitedHealthcare to be investigational. Devices approved under a Humanitarian Use Device exemption are not considered Experimental or Investigational for that indication.

Additional notes clarify that UnitedHealthcare may, at its discretion, consider an otherwise Experimental or Investigational Service to be a Covered Health Care Service when the member is not participating in a qualifying clinical trial and has a sickness or condition likely to cause death within one year of the treatment request, provided there is sufficient evidence that the service has significant potential as an effective treatment. Services that are obtainable only in research settings or are provided solely for protocol-driven data collection remain excluded. Certain promising interventions for terminal illnesses and other items that meet UnitedHealthcare’s specified criteria may also be considered under exception rules.

Transportation, lodging, and meals are explicitly excluded from coverage. This includes fees for all types of transportation (personal vehicle mileage, taxi, medical van, ambulance, airline, train), rental car expenses, mileage reimbursement, lodging (e.g., hotel charges), and meals for the clinical trial participant and one caregiver/companion; corresponding HCPCS S-codes (e.g., S9992, S9994, S9996) are listed to denote these noncovered items.

Billing and Coding for Clinical Trials

Clinical Trial ModifiersModifier

Q0	Investigational clinical service provided in a clinical research study that is in an approved clinical research study.
Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study.

Covered When Criteria Are Met / Not Covered itemsHCPCS

G0276	Blinded procedure for lumbar stenosis, percutaneous image-guided lumbar decompression (PILD) or placebo-control, performed in an approved coverage with evidence development (CED) clinical trial.
G0293	Noncovered surgical procedure(s) using conscious sedation, regional, general, or spinal anesthesia in a Medicare qualifying clinical trial, per day.
G0294	Noncovered procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day.
G2000	Blinded administration of convulsive therapy procedure, either electroconvulsive therapy (ECT) or magnetic seizure therapy (MST), performed in an approved IDE-based clinical trial, per treatment session.
S9988	Services provided as part of a Phase I clinical trial.
S9990	Services provided as part of a Phase II clinical trial.
S9991	Services provided as part of a Phase III clinical trial.
S9992	Transportation costs to and from trial location and local transportation costs (e.g., fares for taxicab or bus) for clinical trial participant and one caregiver/companion.
S9994	Lodging costs (e.g., hotel charges) for clinical trial participant and one caregiver/companion.
S9996	Meals for clinical trial participant and one caregiver/companion.

Clinical Trial Diagnosis CodeICD-10

Z00.6

Encounter for examination for normal comparison and control in clinical research program

inv-10: Life expectancy threshold for special consideration

Life-expectancy thresholdMember has a sickness or condition likely to cause death within one year of the request for treatment

ApplicabilityApplies when the member is not participating in a qualifying Clinical Trial and UnitedHealthcare determines there is sufficient evidence the service has significant potential as an effective treatment

Precondition for considerationUnitedHealthcare must first establish sufficient evidence of significant potential benefit before treating an Experimental/Investigational service as covered

Provider Requirements and Actions

Documentation Required

Qualified Individual

A qualified individual must be covered under the member's health plan and be eligible to participate in the Approved Clinical Trial according to the trial protocol. The individual must either be referred by an in‑network health care professional who has determined participation is appropriate per the trial protocol, or provide the plan with medical and scientific information establishing eligibility per the trial protocol.

Member must be covered under the health plan
Eligibility must follow the trial protocol
Referral by in‑network provider OR member‑provided medical/scientific information

Documentation Required

Protocol, IRB and Medical Records

The Clinical Trial must have a written protocol approved by all relevant Institutional Review Boards (IRBs) prior to enrollment. UnitedHealthcare (Sierra Health and Life) may request documentation of the protocol and IRB approval at any time. Medical records may also be requested to assess whether the member meets clinical criteria; submission of records does not guarantee coverage.

Definitions

inv-22: Approved Clinical Trial — phases I–IV, prevention/detection/treatment criteria and qualifying trial conditions

Phases includedPhase I, Phase II, Phase III, or Phase IV clinical trials are eligible for 'Approved Clinical Trial' status

Scope of studyTrials must relate to prevention, detection, or treatment of cancer or other life‑threatening disease or condition

Protocol and approvalsMust meet Criteria for Approved Clinical Trials (e.g., specified funding/approval sources or FDA investigational new drug oversight) and have a written, scientifically sound protocol approved by relevant IRBs

Qualified individual requirementMember must be covered under the health plan and eligible to participate per the trial protocol (may require referral or medical/scientific documentation)

inv-23: Category B Devices — FDA-determined non-experimental/investigational devices and coverage caveats

Background and Scope

Background: This policy implements PPACA requirements for coverage of routine patient costs associated with participation in qualifying clinical trials related to cancer and other life‑threatening diseases. It defines an Approved Clinical Trial (Phase I–IV meeting specified funding/approval criteria), the conditions under which routine patient costs are covered (services typically provided absent a clinical trial, required for provision or monitoring of the investigational item/service, or needed to prevent or treat complications), and administrative requirements such as a written protocol approved by relevant IRBs and possible documentation requests by UnitedHealthcare. Member‑specific benefit plan documents and applicable mandates govern final benefit determination.

Policy Revision History

2026-01-01Template updateLatest

Policy template updated and noted in Policy History/Revision Information.

2026-01-01Policy effective date

Policy effective date listed as January 1, 2026.