CurrentUnitedHealthcarePolicy CSNC.MP.006.05

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

Defines UnitedHealthcare's reference to mandatory Medicaid coverage of routine patient costs for members participating in qualifying clinical trials in North Carolina and points to the NC Medicaid clinical coverage policy for medical necessity criteria. Applies to providers submitting claims for clinical trial–related routine costs for North Carolina members.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSNC.MP.006.05

Change TypeClarified supporting information (non-material)

Effective DateSep 1, 2025

Next Review Date

Key ActionFollow North Carolina Medicaid Clinical Coverage Policy 1A-39 for medical necessity and prior authorization requirements.

SourceLink

POLICY UPDATE CHANGES

Supporting Information Updated FDA section to reflect the most current information

1applicable state (North Carolina)

CSNC.MP.006.05policy identifier

2025-09-01effective date

Z00.6, Q, Q1example codes

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Coverage Criteria

Medical necessity — follow NC Medicaid 1A-39

Coverage for routine patient costs is governed by the referenced state Medicaid clinical coverage policy and is not redefined here.

State-governed medical necessity: Medical necessity clinical coverage criteria are determined by the North Carolina Medicaid (Division of Health Benefits) Clinical Coverage Policy 1A-39 for Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials.

Providers must follow NC Medicaid 1A-39 for specific criteria

Codes in the applicable codes list that are marked with an asterisk (*) are not included on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program. Providers submitting claims for North Carolina members should confirm state fee-schedule status before assuming coverage or reimbursement for those asterisked codes.

Inclusion of a procedure or modifier code in this policy does not by itself indicate that the service is covered or eligible for reimbursement. Some codes in the list are specifically identified as Not Covered (for example, G0293 and G0294), and other listed codes may be subject to limitations or exclusion by the payer or state program. Providers must verify coverage and reimbursement rules with the applicable payor policies and state fee schedule prior to billing.

Applicable Codes and Modifiers

Applicable procedure and diagnosis codes (reference/listing)mixed

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 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.

1–10 of 11

1/2

Clinical trial modifiersModifier

Q	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.

Provider Actions and Billing Guidance

Note

Reference for Medical Necessity / Prior Authorization

For medical necessity criteria and prior authorization requirements for routine patient costs in qualifying clinical trials, refer to the North Carolina Medicaid Clinical Coverage Policy: 1A-39 (Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials).

Denial Risk

Claims Lacking Clinical Trial Modifiers

Claims that do not include the appropriate clinical trial modifiers may not be identified as clinical trial-related and could be adjudicated incorrectly. Providers should ensure clinical trial modifiers are submitted when applicable to avoid misclassification and potential denials or incorrect payment.

Claims lacking clinical trial modifiers may be adjudicated incorrectly

Billing Rule

Use of Procedure/Modifier/Diagnosis Codes

Use the listed procedure and modifier codes and the diagnosis code Z00.6 when applicable to identify clinical trial-related services. Inclusion of these codes in a claim may signal the service was provided in connection with a qualifying clinical trial; however, listing a code does not guarantee coverage or payment. Codes noted with an asterisk in state guidance may not be on the NC Medicaid Fee Schedule and may not be covered.

Procedure/HCPCS codes: G0276, G0293, G0294, G2000
Modifier examples: Q, Q1 (investigational / routine clinical service in an approved clinical research study)
Diagnosis: Z00.6 (Encounter for examination for normal comparison and control in clinical research program)
Not all clinical trial claims are limited to these codes; submission of these codes typically identifies a clinical trial claim

Prior Authorization

Provider Billing Actions and Verification

Provider actions: submit appropriate clinical trial modifiers and applicable procedure/diagnosis codes (including Z00.6 when relevant). Be aware some codes used in clinical trials (marked by state guidance) may not be on the NC Medicaid fee schedule and could affect coverage or reimbursement.

Submit clinical trial modifiers (e.g., Q, Q1) when services are part of an approved clinical research study
Include applicable procedure/HCPCS codes and diagnosis code Z00.6 to properly identify clinical trial services
Verify state fee schedule status for codes marked with an asterisk to confirm coverage eligibility

Background

This policy addresses routine health care costs incurred by patients participating in qualifying clinical trials and does not redefine medical necessity criteria. Medical necessity for routine patient costs is determined by the North Carolina Medicaid Clinical Coverage Policy 1A-39, and providers must follow that state policy for coverage determinations and any prior authorization requirements. The policy also notes that diagnosis code Z00.6 can be used to identify clinical trial–related encounters when applicable.

OpenPayer

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

Coverage Criteria

Applicable Codes and Modifiers

Provider Actions and Billing Guidance

Definitions

Background