CurrentUnitedHealthcarePolicy CSO18OH.C

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

Defines UnitedHealthcare's application of mandatory Medicaid coverage for routine patient costs associated with qualifying clinical trials for members in Ohio, and notes reliance on federal and Ohio Administrative Code requirements.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSO18OH.C

Change TypeSupporting information updated

Effective DateOctober 1 2025

Next Review Date

Key ActionProvider and principal investigator must submit an attestation using the Secretary's streamlined uniform form to establish trial appropriateness and qualify routine costs for coverage.

SourceLink

POLICY UPDATE CHANGES

Supporting information updated; FDA section refreshed and previous policy version CSO18OH.B archived.

Ohio-onlystate applicability

Phase I-IVEligible clinical trial phases referenced

13 codesApplicable codes

2025-10-01Effective date

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Covered routine patient costs

Covered when ALL of the following are met

Qualified trial type: The study meets Criteria for Qualified Clinical Trials (e.g., NIH/NCI; CDC, CMS, AHRQ support; cooperative groups; DOD/VA peer‑reviewed studies; qualified non‑governmental research entities comparable to NIH peer review; or is conducted under an IND/IDE or is an exempt drug trial).

See policy section 'Criteria for Qualified Clinical Trials' for sponsor and IND/IDE details.

Phase: Trial is Phase I, Early Phase I, Phase II, Phase III, or Phase IV as defined in the policy.

Phases defined under 'Qualified Clinical Trial' section.

Purpose: The study is being conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition.

Covered services scope: The services are routine patient costs: items or services provided to the individual under the qualifying clinical trial to prevent, diagnose, monitor, or treat complications from participation, and any item or service required solely for provision of the investigational item/service (including administration) that would otherwise be covered outside the trial (examples include physician services, laboratory services, and medical imaging services).

Attestation: Coverage determinations are based on an attestation by the health care provider and principal investigator using the Secretary's streamlined uniform form (public trial registry information may be referenced).

Provider/principal investigator attestation required per policy.

This policy addresses coverage of routine patient costs associated with participation in qualifying clinical trials. Routine costs are covered only when they meet the policy's definition of routine patient costs and the trial itself meets requirements for a Qualified Clinical Trial (see Definitions). Routine patient costs include items and services ordinarily furnished to diagnose, monitor, prevent, or treat complications of the investigational intervention and services required for the safe administration of the investigational item when those services would be covered outside the trial. The investigational item or service that is the subject of the qualifying clinical trial is not considered a routine patient cost if it is not otherwise covered outside the trial.

Services that do not meet Ohio-specific medical necessity criteria (see Ohio Administrative Code Rule 5160-1-61) are not covered under this policy. In addition, routine patient costs explicitly exclude the investigational item or service that is the subject of the qualifying clinical trial when that item is not covered outside the trial; items and services provided solely to satisfy data collection and analysis needs and not used in direct clinical management; items provided free of charge by research sponsors; and laboratory tests or imaging performed at protocol-driven frequencies that are not consistent with signs, symptoms, or accepted standards of care.

Applicable Codes

Applicable codesmixed

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 of a Phase I clinical trial part.
S9990	Services provided as of a Phase II clinical trial part.
S9991	Services provided as of a Phase III clinical trial part.
S9992	Transportation costs to and from trial location and local transportation costs for participant and one caregiver/companion.
S9994	Lodging costs for clinical trial participant and one caregiver/companion.
S9996	Meals for clinical trial participant and one caregiver/companion.

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Provider Attestations and Billing Requirements

Prior Authorization

Provider/principal investigator attestation required

An attestation by the health care provider and principal investigator using the Secretary’s streamlined uniform form is required to establish appropriateness of the clinical trial and qualify routine patient costs for coverage.

Use the streamlined, uniform form developed for use by the Secretary; the form may reference publicly available trial registry information (e.g., ClinicalTrials.gov).
Follow applicable federal, state (OAC), and contractual rules when making coverage determinations.

Step Therapy

Step therapy — not specified

No step therapy requirements are specified in this policy; UnitedHealthcare relies on InterQual and other UnitedHealthcare criteria when applicable to determine coverage decisions.

If InterQual does not have applicable criteria, UnitedHealthcare may use its Medical Policies, Coverage Determination Guidelines, or Utilization Review Guidelines approved by the Ohio Department for Medicaid Services.

Documentation Required

Attestation required and governing authority

Coverage determinations will be based on an attestation by the health care provider and principal investigator using the Secretary’s streamlined uniform form; federal, state (OAC), or contractual requirements must be checked when deciding coverage.

The attestation form includes the option to reference qualifying Clinical Trial information that is publicly available on a Secretary‑maintained website (e.g., ClinicalTrials.gov).
In the event of conflict, federal, state (OAC), or contractual requirements govern coverage decisions.

Denial Risk

Coverage exclusion triggers — denial risk

Items or services that are the investigational item/service not otherwise covered outside the trial, items provided solely for data collection, sponsor‑provided free items, and laboratory or imaging tests performed at protocol‑driven frequencies not consistent with standards of care are excluded and may trigger denial.

Examples of exclusions: services solely for data collection/analysis not used in direct clinical management; items provided free by research sponsors; lab tests and imaging done at protocol‑dictated frequencies inconsistent with signs/symptoms or standards of care.

Key Definitions

Qualified Clinical Trial

DefinitionA Phase I, Early Phase I, Phase II, Phase III, or Phase IV clinical trial that meets federal criteria for a Qualified Clinical Trial and is conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition.

Eligible phasesPhase I; Early Phase I (formerly Phase 0); Phase II; Phase III; Phase IV — phases defined by purpose and participant exposure per regulatory guidance.

Federal criteria for qualificationMeets requirements under Criteria for Qualified Clinical Trials, including support or review by federal agencies or comparable peer-reviewed entities, IND/IDE status, or other federal determinations as specified in the policy.

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

Scope noteIncludes trials with objectives ranging from safety and dosing (Phase I/Early Phase I) to efficacy and broader population assessment (Phases II–IV).

Background and Rationale

Clinical trials are research studies that test medical interventions — drugs, biologics, devices, procedures, or behavioral strategies — to generate medical knowledge about prevention, detection, or treatment of disease. This policy implements mandatory Medicaid coverage in Ohio for routine patient costs associated with qualifying clinical trials while distinguishing those routine costs from investigational items and protocol-driven services that are excluded from coverage. Coverage determinations will reference federal and state regulatory requirements and the policy's attestation process to confirm a trial's qualifications and appropriate billing for routine services.

OpenPayer

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

Coverage Criteria for Routine Patient Costs

Applicable Codes

Provider Attestations and Billing Requirements

Key Definitions

Background and Rationale