CurrentUnitedHealthcarePolicy CS018LA.R

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

Defines Louisiana Medicaid coverage for routine items and services provided to enrollees participating in qualifying clinical trials; applies to providers and UnitedHealthcare Community Plan administration in Louisiana.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS018LA.R

Change TypeRevised — material updates to coverage rationale, definitions, and determinations

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit an attestation using the Medicaid attestation form and expect an expedited coverage determination within 72 hours.

SourceLink

POLICY UPDATE CHANGES

Application: Added language that the Coverage Rationale represents Louisiana Medicaid coverage policy and is set forth in accordance with State requirements.

Coverage Rationale: Clarified that Louisiana Medicaid shall cover any item or service provided to an enrollee in a qualifying clinical trial to the extent it would otherwise be covered when not participating, including items to present, diagnose, monitor, or treat complications from participation.

Qualifying Clinical Trial: Revised definition listing federal sponsors/approvers and exemptions that qualify a trial.

Coverage determinations: Added expedited decision timeline (72 hours), acceptance regardless of provider geographic/network affiliation, attestation requirement, and prohibition on requiring trial protocols.

Coverage limitations: Specified noncoverage of investigational items under study, services solely for data collection not used in direct clinical care, and services not otherwise covered by Louisiana Medicaid.

72 hourstimeframe for expedited coverage determination

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Coverage Criteria for Routine Costs in Qualifying Clinical Trials

Routine care coverage in qualifying clinical trials

Covered when ALL of the following are met

Basic coverage requirement: Item or service is provided to an enrollee participating in a qualifying clinical trial and would otherwise be covered for the enrollee when not participating in the trial.

Includes items/services to present, diagnose, monitor, or treat complications resulting from participation.

Qualifying clinical trial criteria: The clinical trial addresses prevention, detection, or treatment of a serious or life-threatening disease or condition and is approved, conducted, or supported by specified federal agencies or meets peer-review/funding or IND/biologic exemption criteria listed in the policy.

See enumerated sponsors/criteria (National Institutes of Health; Centers for Disease Control and Prevention; Agency for Healthcare Research and Quality; Centers for Medicare & Medicaid Services; cooperative groups or centers of listed entities; Department of Defense; Department of Veterans Affairs; qualified non-governmental research entities; trials approved/funded with comparable peer review; investigational new drug (IND) or biologic exemptions; exempt drug trials).

Louisiana Medicaid shall not cover the investigational item or service that is the subject of the qualifying clinical trial. Claims for such investigational items or services are excluded and may be denied.

Services provided solely to satisfy data collection and analysis needs for the qualifying clinical trial that are not used in the direct clinical management of the individual are not covered. Such services are considered not medically necessary in this context and may be denied.

Coding and Claim Modifiers

Applicable HCPCS/CPT/Other 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 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.
S9996	Meals for clinical trial participant and one caregiver/companion.

Modifiers indicating clinical trial claim statusHCPCS

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.

Example Diagnosis CodesICD-10

Z00.6

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

inv-07: Expedited decision timeframe — 72 hours

Expedited decision timeframeCoverage determinations shall be expedited and completed within 72 hours.

No geographic/network limitsDeterminations are made without limitation on the geographic location or network affiliation of the treating provider or principal investigator.

Attestation requiredDeterminations are based on attestation by the treating provider and principal investigator using the Medicaid attestation form and kept on file by the provider.

Provider Responsibilities, Documentation, and Denials

Note

Expedited determination and attestation — Coverage determinations for routine care in qualifying clinical trials must be expedited and completed within 72 hours and are to be made...

Coverage determinations for routine care in qualifying clinical trials must be expedited and completed within 72 hours. Determinations must be made regardless of the geographic location or network affiliation of the treating provider or the principal investigator.

Expedited and completed within 72 hours
No limitation based on provider or principal investigator geographic location or network affiliation

Documentation Required

Attestation form requirement — Providers must keep on file an attestation regarding the appropriateness of the qualifying clinical trial completed by the treating provider

Providers must retain on file an attestation regarding the appropriateness of the qualifying clinical trial completed by the treating provider and principal investigator. Use the specified attestation form and keep a copy in the patient’s medical record: https://www.medicaid.gov/resourcesfor-states/downloads/medicaid-attest-form.docx

Definitions

inv-13: Qualifying clinical trial — definition

Definition summaryA qualifying clinical trial is a clinical trial in any phase related to prevention, detection, or treatment of a serious or life‑threatening disease or condition that meets enumerated federal sponsorship/approval, peer‑review/funding, or IND/biologic exemption criteria.

Federal sponsors/approvers listedIncludes NIH, CDC, AHRQ, CMS, cooperative groups or centers associated with those entities, Department of Defense, Department of Veterans Affairs, and qualified non‑governmental research entities per NIH guidelines.

Peer‑review/funding criterionTrials approved or funded and reviewed through a peer review system comparable to NIH peer review that assures unbiased review by qualified individuals with no interest in the outcome.

IND/biologic exemptionsTrials conducted pursuant to an investigational new drug exemption under 21 U.S.C. §335(i) or an exemption for a biological product under 21 U.S.C. §262(a)(3), or drug trials exempt from an IND application.

Background

Qualifying clinical trials include studies in any phase that address prevention, detection, or treatment of serious or life‑threatening conditions. Routine items and services provided to an enrollee participating in such a qualifying clinical trial are covered to the extent they would be covered when the enrollee is not participating in the trial, including items to present, diagnose, monitor, or treat complications resulting from participation.

Revision History and Material Changes

2026-01-01material_revisionLatest

Policy updated to state that the Coverage Rationale represents Louisiana Medicaid coverage policy and to clarify that routine care provided to enrollees in qualifying clinical trials is covered to the extent it would be covered outside the trial, including items to present, diagnose, monitor, or treat complications.

2026-01-01definition_revision

Revised the definition of 'Qualifying Clinical Trial' to enumerate federal sponsors/approvers and to include peer-reviewed funded studies and IND/biologic exemptions as qualifying criteria.