CurrentUnitedHealthcarePolicy CS018PA.S

Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for Pennsylvania Only)

Defines UnitedHealthcare's application of Pennsylvania-required Medicaid coverage for routine patient costs associated with qualifying clinical trials and outlines which trials and services are covered or excluded; applies to Medicaid members in Pennsylvania.

Policy Summary

PayerUnitedHealthcare

PolicyMandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for Pennsylvania Only)

Policy CodePolicy CS018PA.S

Change TypeNo material change

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit a provider/principal investigator attestation using the Secretary's uniform form when requesting coverage determinations for routine trial costs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Pennsylvaniajurisdiction

Phases I–IVtrial phases

Physician, lab, imagingroutine services

Q0, Q1, S9990–S9992codes listed

Z00.6diagnosis

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Coverage Criteria — Routine Costs in Qualified Clinical Trials

Eligibility for routine cost coverage

Covered when ALL of the following are met:

Qualified trial criteria: Study is approved, conducted, or supported by one or more of: NIH (including NCI), CDC, AHRQ, CMS, a cooperative group or center of the listed entities or DOD or VA, a qualified non‑governmental research entity identified by NIH guidelines, or reviewed/approved by VA/DOD/DOE through a peer‑review system the Secretary determines to meet NIH‑comparable standards; OR the study is conducted under an FDA investigational new drug (IND) exemption or a biological product exemption; OR the drug trial is exempt from requiring such an exemption.

See policy for full list of qualifying agencies and peer‑review requirements.

Phase: Trial is Phase I, Phase II, Phase III, or Phase IV and is being conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition.

Phases defined in policy.

Attestation: Coverage determinations are based on an attestation by the health care provider and the principal investigator using the Secretary's streamlined uniform form; the attestation may reference publicly available trial information (e.g., clinicaltrials.gov).

Provider/principal investigator must submit the required attestation form.

Routine patient costs do not include an item or service that is the investigational item or service that is the subject of the qualifying clinical trial and not otherwise covered outside of the clinical trial. Additionally, costs for items and services provided solely to satisfy data collection and analysis needs for the qualifying clinical trial and not used in the direct clinical management of the member are excluded. Examples include laboratory tests and imaging performed at frequencies dictated only by the study protocol and not consistent with standard care, and items or services provided free of charge by research sponsors.

Applicable Coding and Diagnosis

Applicable claim 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

HCPCS / S codesHCPCS

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, current covered gold standard) or magnetic seizure therapy (MST, noncovered experimental therapy), 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

Diagnosis codesICD-10

Z00.6

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

Provider Attestation, Documentation, and Denial Triggers

Prior Authorization

Attestation Required for Coverage

Coverage determinations will be based on an attestation regarding the appropriateness of the Clinical Trial by the health care provider and principal investigator. Providers must submit the attestation using the streamlined, uniform form developed for use by the Secretary and may reference qualifying Clinical Trial information publicly available on a Secretary-maintained website (for example, clinicaltrials.gov).

Attestation must be completed by the treating provider and the trial principal investigator.
The attestation form may include a link or reference to the qualifying Clinical Trial record (e.g., clinicaltrials.gov).
Coverage decisions rely on the information provided in the attestation and any referenced public trial details.

Documentation Required

Attestation and Documentation

Documentation supporting routine patient costs must show the items or services are provided to prevent, diagnose, monitor, or treat complications of trial participation or are otherwise services that would be covered outside the trial. Include clinical rationale linking services to direct patient care rather than data collection.

Background — Clinical Trials and Routine Cost Coverage

Clinical trials are research studies that evaluate interventions and may require procedures, tests, or services beyond standard care. For the purposes of routine cost coverage, services that exist solely to fulfill research data collection—rather than to manage the participant’s clinical condition—are considered investigational and are not included as routine patient costs. Refer to federal, state, and contractual requirements for details on qualifying clinical trials and mandatory Medicaid coverage of routine costs.

Definitions — Qualified Clinical Trial

Qualified Clinical Trial — key facts

DefinitionPhase I–IV clinical trials conducted for prevention, detection, or treatment of serious or life‑threatening diseases or conditions that meet the policy's Criteria for Qualified Clinical Trials.

Included trial phasesPhase I, Phase II, Phase III, Phase IV (Early Phase 1/Phase 0 excluded from qualified definition).

Purpose requirementTrial must be conducted in relation to prevention, detection, or treatment of a serious or life‑threatening disease or condition.

Standards for qualificationMust meet the requirements under the policy's Criteria for Qualified Clinical Trials (see policy for list of acceptable federal support, FDA IND/biologic exemptions, or equivalent peer‑review).

Phase descriptions referencePhase definitions (Early Phase 1, Phase 1, Phase 2, Phase 3, Phase 4) follow ClinicalTrials.gov descriptions for scope and intent of each phase.