CurrentUnitedHealthcarePolicy CSO18TN.S

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

Governs coverage of routine patient costs for Medicaid and CoverKids members in Tennessee who participate in qualifying clinical trials; specifies covered services, exclusions, definitions, and applicable billing codes.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSO18TN.S

Change TypeSupporting information updatedarchived prior version

Effective DateSep 1, 2025

Next Review Date

Key ActionIdentify and attest that the trial meets Qualified Clinical Trial criteria and submit claims with appropriate clinical trial modifiers or listed codes.

SourceLink

POLICY UPDATE CHANGES

Supporting Information Updated FDA section to reflect the most current information; archived previous policy version CSO18TN.R.

Tennesseestate program applicability

2025-09-01effective

physician, lab, imagingexamples covered

Z00.6trial diagnosis code

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.

Covered Routine Patient Costs During Qualified Clinical Trials

Covered when ALL of the following are met

Qualified Clinical Trial affiliation: The study or investigation is approved, conducted, or supported (which may include funding through in‑kind contributions) by one or more of the following: National Institutes of Health (NIH) (includes NCI); Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention (CDC); Centers for Medicare and Medicaid Services (CMS); a qualified non‑governmental research entity identified in NIH guidelines for center support grants; a cooperative group or center of the entities above or the Department of Defense (DOD) or Department of Veterans Affairs (VA); or the Department of Veterans Affairs, DOD, or Department of Energy when reviewed and approved through a peer‑review system determined by the HHS Secretary to meet NIH‑comparable standards.

See list of qualifying entities and peer review requirements.

Clinical relevance: The trial is conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition and meets the Criteria for Qualified Clinical Trials.

Definition of Qualified Clinical Trial applies.

Attestation and identification: Coverage determinations are based on an attestation regarding the appropriateness of the clinical trial by the health care Secretary; publicly available trial information (e.g., ClinicalTrials.gov) may be referenced.

Provider or responsible party must provide attestation as part of coverage determination.

Routine patient costs: Items and services that would otherwise be covered outside the course of trial participation are covered, including physician services, laboratory services, and medical imaging; also includes items/services to prevent, diagnose, monitor, or treat complications of trial participation and any item or service required solely for provision or administration of the investigational item when those items/services would otherwise be covered.

Protocol‑dictated services provided solely for data collection or at frequencies beyond standard of care are not considered routine patient costs.

Coverage excludes the investigational item or service that is the subject of the qualifying clinical trial when that item or service is not otherwise covered outside the trial. Additionally, items and services provided free of charge by the research sponsor are excluded from routine patient cost coverage. See federal, state, and contractual requirements for full details.

Services that are provided solely to satisfy data collection and analysis for the qualifying clinical trial and that are not used in the direct clinical management of the member are not considered routine patient costs and are excluded. Also excluded are laboratory tests and imaging studies performed at a frequency dictated by the study protocol that are not consistent with the member’s signs and symptoms or other standards of care for that diagnosis or treatment.

Applicable Codes and Examples

Applicable Codes (examples listed)mixed

Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study
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) either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day
G2000	Blinded administration of convulsive therapy procedure 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 for clinical trial participant and one caregiver/companion
S9994	Lodging costs for clinical trial participant and one caregiver/companion

1–10 of 12

1/2

Clinical Trial Claim Modifiers/Codesmixed

Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study
Z00.6	Encounter for examination for normal comparison and control in clinical research program

Provider Billing and Action Requirements

Billing Rule

Clinical Trial Claim Identification

Claims that include clinical trial modifiers or specified clinical-trial diagnosis/procedure codes should be identified and processed as clinical trial claims. Providers must append applicable clinical trial modifiers (for example, Q0, Q1, or other designated modifiers) or include the listed diagnosis code (e.g., Z00.6) when submitting claims so the claim can be recognized as associated with a qualifying clinical trial. Clinical trial coding is not limited to the examples provided; presence of these modifiers or codes is sufficient to mark a claim as a clinical trial claim for processing purposes.

Examples of clinical-trial modifiers: Q0, Q1 (not exhaustive)
Example diagnosis: Z00.6 (Encounter for examination for normal comparison and control in clinical research program)

Note

Services That Are Routine (vs. Investigational)

Routine patient costs that would otherwise be covered outside the trial are covered when provided to a participant in a qualifying clinical trial. This includes physician services, laboratory services, medical imaging, and items or services required solely for the provision or administration of the investigational item or service when those items/services would otherwise be covered for the condition. Providers should bill routine services as they would outside the trial when the service is used for prevention, diagnosis, monitoring, or treatment of complications related to trial participation or is required for administering the investigational therapy.

Covered routine services include physician services, laboratory tests, and medical imaging when consistent with standard care
Includes items/services required solely to provide or administer the investigational item/service if they would be covered outside the trial

Denial Risk

Services That Are the Investigational Item

Investigational items or services that are the primary subject of the qualifying clinical trial and are not otherwise covered outside the trial are excluded from routine patient cost coverage. Additionally, items and services provided solely to satisfy data collection and analysis needs (and not used in the direct clinical management of the member), sponsor-provided free items, and tests or imaging performed at protocol-driven frequencies that exceed standards of care are not considered routine and are not covered.

Not covered: the investigational item/service that is the subject of the trial when not covered outside the trial
Not covered: items/services provided solely for data collection/analysis and not used for direct clinical management
Not covered: sponsor-provided free items and protocol-driven tests/imaging inconsistent with signs/symptoms or standard care

Documentation Required

Provider Attestation and Documentation

Coverage determinations may rely on provider attestation regarding the appropriateness of the qualifying clinical trial and may reference publicly available information about the trial (for example, records on ClinicalTrials.gov or other Secretary-maintained resources). Providers should be prepared to supply attestation and reference details when requested. No specific step therapy requirements are described in this policy for clinical trial-related services.

Coverage determinations may use provider attestation and publicly available trial information (e.g., ClinicalTrials.gov)
Providers should maintain documentation supporting attestation upon request
No step therapy specifics are provided in this policy

Denial Risk

Investigational / Research-only Services Not Routine

Services provided solely to satisfy data collection or analysis requirements for the clinical trial and not used in the direct clinical management of the member are not routine and should not be billed as covered routine patient costs. Examples include protocol-only laboratory tests or imaging done at frequencies beyond standard clinical care and items provided free by the research sponsor. Providers should segregate billing for non-routine, sponsor-funded, or research-only items to avoid inappropriate reimbursement claims.

Do not bill protocol-only tests or imaging done solely for data collection as routine covered services
Do not bill sponsor-provided items that are furnished free of charge to trial participants
Segregate billing for research-only procedures from routine clinical care

Definitions

Qualified Clinical Trial

DefinitionA Qualified Clinical Trial is a study conducted in relation to the prevention, detection, or treatment of any serious or life‑threatening disease or condition and that meets the policy's Criteria for Qualified Clinical Trials.

ScopeIncludes trials whose purpose is prevention, detection, or treatment of serious or life‑threatening conditions; routine patient costs may be covered when the trial meets qualifying criteria.

Relation to coverageCoverage of routine patient costs applies only when the trial both meets the definition above and the policy's specified Criteria for Qualified Clinical Trials.

Clinical Trial Phases

Phase 1Trials that focus on safety, usually conducted with healthy volunteers to determine the drug's most frequent and serious adverse events and how the drug is metabolized and excreted; typically involve a small number of participants.

Early Phase 1 (Phase 0)Exploratory trials conducted before traditional Phase 1 to investigate how or whether a drug affects the body; involve very limited human exposure and have no therapeutic or diagnostic goals (e.g., screening or microdose studies).

Phase 2Trials that provide preliminary data on whether a drug works in people with a certain condition (effectiveness); participants receiving the drug may be compared with those receiving placebo or another treatment; safety and short‑term adverse events continue to be evaluated.

Phase 3Trials that gather more information about a drug's safety and effectiveness by studying different populations, dosages, and use in combination with other drugs; these studies typically involve larger numbers of participants.

Phase 4Post‑marketing trials occurring after FDA approval, including required or agreed post‑market studies to gather additional information about a drug's safety, efficacy, or optimal use.

OpenPayer

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

Coverage Criteria for Routine Patient Costs

Applicable Codes and Examples

Provider Billing and Action Requirements

Background

Definitions

Policy History / Revision Information