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Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials (for North Carolina Only)
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Defines UnitedHealthcare Community Plan policy implementing North Carolina Medicaid requirements to cover routine patient costs associated with qualifying clinical trials; applies only to North Carolina Medicaid members and providers administering services in that state.
Medical Records Documentation Used for Reviews section added language clarifying documentation requirements to support medical necessity and that documentation may be requested.
Coverage Criteria
Medical necessity / Coverage delegation
Coverage follows North Carolina Medicaid Clinical Coverage Policy 1A-39
Providers must consult 1A-39 for specific inclusion/exclusion criteria and clinical requirements.
The codes listed in this policy are provided for reference only. Listing a code does not imply the service is covered, and inclusion of a code is not a guarantee of reimbursement or claim payment. Coverage decisions are determined by federal, state, and contractual requirements and applicable law; some codes included here — including those noted with an asterisk in the source — may not appear on the State of North Carolina Medicaid Fee Schedule and therefore may not be covered by the State Medicaid Program. Providers must verify coverage and applicable payment rules with the member’s benefit plan and the NC Medicaid fee schedule before submitting claims.
Coding and Modifiers
| 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. |
| Z00.6 | Encounter for examination for normal comparison and control in clinical research program. |
| G0276 | Referenced — Covered When Criteria Are Met (per policy listing). |
| G0293 | Referenced — Noncovered surgical procedure(s) using conscious sedation, regional, general, or spinal anesthesia (per listing). |
| G0294 | Referenced — Noncovered procedure(s) using either no anesthesia or local anesthesia only (per listing). |
| S9990 | Services provided as part of a Phase II clinical trial. |
| S9991 | Services provided as part of a Phase II clinical trial. |
| 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. |
Provider Actions, Billing & Documentation
Coding/claim identifiers required for clinical trial claims
Claims identified as clinical trial claims should include the appropriate clinical trial modifiers or diagnosis code when billing. Use modifier Q0 for investigational clinical services or Q1 for routine clinical services provided in an approved clinical research study, and/or include diagnosis code Z00.6 as applicable; include relevant procedure and trial-support codes as required by the claim. Listing of procedure or support codes in this policy is for reference only and does not guarantee coverage — providers must verify the State fee schedule and contract for coverage and reimbursement.
- Use modifier Q0 for investigational clinical services in an approved clinical research study.
- Use modifier Q1 for routine clinical services in an approved clinical research study.
- Include diagnosis code Z00.6 (encounter for examination for normal comparison and control in clinical research) when applicable.
- Procedure and participant-support codes listed are reference only; presence in the policy does not imply coverage or payment.
Maintain complete, requestable medical records for trial-related services
Ensure the patient medical record contains complete, legible documentation that supports medical necessity for services related to clinical trial participation. Documentation may be requested and absence of required records can affect coverage decisions.
- Medical records documentation may be required to assess whether the member meets clinical criteria for coverage and does not guarantee payment.
- Documentation must be made available upon request.
Required medical record documentation to support medical necessity
The patient's medical record must include legible documentation that fully supports medical necessity, including relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
- Include relevant medical history and physical examination findings.
- Include results of pertinent diagnostic tests or procedures.
- Keep documentation legible, maintained in the medical record, and available upon request.
Documentation-related denial risk for insufficient records
Lack of sufficient medical record documentation that fully supports the medical necessity for requested services may affect coverage determinations and result in denial.
- If documentation is missing, incomplete, illegible, or not provided upon request, coverage may be denied.
Definitions
Background
This policy implements the North Carolina Medicaid requirement to cover routine patient costs associated with participation in qualifying clinical trials, as set forth in the NC Medicaid Clinical Coverage Policy 1A-39. UnitedHealthcare defers to the referenced NC Medicaid policy for the medical necessity clinical criteria rather than duplicating those criteria in this document. Federal FDA materials included in the source are provided for informational purposes only and do not themselves determine coverage.
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