CurrentUnitedHealthcarePolicy CS018ID.A

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

Defines coverage of routine patient costs for members participating in qualified clinical trials in Idaho Medicaid (Idaho Medicaid Plus), including definitions of qualifying trials, covered routine costs, exclusions, applicable codes, and provider attestation requirements. Applies only to Idaho.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS018ID.A

Change TypeNew Medical Policy

Effective DateJun 1, 2025

Next Review Date

Key ActionProvider and principal investigator must attest to the appropriateness of the clinical trial using the streamlined, uniform form developed for use by the Secretary; may reference public trial information (e.g., clinicaltrials.gov).

POLICY UPDATE CHANGES

New Medical Policy created

Idaho-onlyState scope

Routine costs covered when criteria metCoverage summary

Transport/Lodging/MealsExcluded supports

Coverage Summary

Scope: This policy implements mandatory Medicaid coverage in Idaho for routine patient costs associated with participation in Qualified Clinical Trials for Idaho Medicaid members (including Idaho Medicaid Plus). Summary: Idaho will cover routine patient costs when trial criteria are met and requires provider attestation for coverage determinations. Effective date: 2025-06-01. Coverage stance: covered_with_criteria.

Medical Necessity / Coverage Criteria

Qualified Clinical Trial criteria

The Qualified Clinical Trial must meet ALL of the following:

ALL of the following

Trial is Phase I, Phase II, Phase III, or Phase IV clinical trial
Trial is conducted in relation to the prevention, detection, or treatment of any serious or life‑threatening disease or condition
Trial meets requirements under Criteria for Qualified Clinical Trials (i.e., is described in section 1, 2, or 3 below)
Study is approved, conducted, or supported by ONE of
- National Institutes of Health (NIH) including National Cancer Institute (NCI)
- Centers for Disease Control and Prevention (CDC)
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Medicare and Medicaid Services (CMS)
- A cooperative group or center of any of the entities described above or the Department of Defense (DOD) or the Department of Veterans Affairs (VA)
- A qualified non-governmental research entity identified in NIH guidelines for center support grants
- Or Department studies with peer review requirements
  - Department of Veterans Affairs, Department of Defense, or Department of Energy
  - Study has been reviewed and approved through a system of peer review determined by the Secretary of HHS to be comparable to NIH peer review and to ensure unbiased review by qualified individuals with no interest in outcome

Additional requirements for coverage determination

Coverage determinations require ALL of the following:

ALL of the following

Attestation regarding appropriateness of the clinical trial by the health care provider and principal investigator
Attestation must be made using a streamlined, uniform form developed for use by the Secretary and may reference public trial information (e.g., clinicaltrials.gov)

Covered routine patient costs

Routine patient costs are covered when they would otherwise be covered outside the clinical trial and include ALL of the following types of services:

ANY of the following

Any item or service provided to prevent, diagnose, monitor, or treat complications resulting from participation in the qualifying clinical trial, to the extent such items/services would otherwise be covered
Any item or service required solely for the provision of the investigational item or service that is the subject of the qualifying clinical trial, including administration of the investigational item/service
Physician services
Laboratory services
Medical imaging services

Coverage exclusions (Not routine patient costs)

The following are NOT considered routine patient costs:

ANY of the following

The investigational item or service that is the subject of the qualifying clinical trial when it is not otherwise covered outside of the clinical trial
Items/services provided solely to satisfy data collection and analysis needs for the qualifying clinical trial and not used in direct clinical management (examples: lab tests and imaging done at protocol‑dictated frequency not consistent with signs/symptoms or standards of care)
Items and services provided by research sponsors free of charge for any person enrolled in the trial

Coding

Clinical trial modifiersModifier

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.

Covered when criteria are met / Applicable CPT/HCPCS referencedmixedCovered

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 participant and one caregiver/companion (listed as Not Covered).
S9994	Lodging costs for participant and one caregiver/companion (listed as Not Covered).
S9996	Meals for clinical trial participant and one caregiver/companion (listed as Not Covered).

Clinical trial diagnosis codeICD-10

Z00.6

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

Provider Actions & Billing Rules

Documentation Required

Provider attestation requirement

Provider and principal investigator must attest to the appropriateness of the clinical trial using the streamlined, uniform form developed for use by the Secretary; the attestation may reference publicly available trial information (for example, clinicaltrials.gov).

Billing Rule

Use of clinical trial modifiers

Claims that include modifiers Q0 or Q1 are considered clinical trial claims; clinical trial claims may also include diagnosis code Z00.6 to indicate a clinical trial encounter.

Q0
Q1
Z00.6

Background

Federal legal basis: policy implements mandatory Medicaid coverage per federal law and guidance including 42 USC 1396d and the federal guidance on Mandatory Medicaid Coverage of Routine Patient Costs Furnished in Connection with Participation in Qualifying Clinical Trials. Purpose: to require Medicaid coverage of routine patient costs for qualifying clinical trials. What the policy clarifies: the policy defines Qualified Clinical Trials (Phases I–IV meeting specified approval/support criteria), lists which routine services are covered (for example, physician services, laboratory services, medical imaging, and items to prevent/diagnose/treat complications or required to administer the investigational item), specifies explicit exclusions (investigational items not otherwise covered; protocol-only data collection items; items provided free by sponsors), and documents the required provider/principal investigator attestation using the streamlined uniform form. Applicability: applies only to Idaho Medicaid members (Idaho Medicaid Plus and Idaho state plans).

Definitions

Qualified Clinical TrialA Phase I–IV clinical trial conducted for prevention, detection, or treatment of a serious or life‑threatening disease or condition that meets the listed criteria for being approved, conducted, or supported by specified entities.

Routine patient costsItems/services provided to prevent, diagnose, monitor, or treat complications from trial participation or required for provision/administration of the investigational item/service that would otherwise be covered outside the trial.

Not Covered / Experimental

Explicit exclusions: the policy states routine patient costs do NOT include the investigational item or service that is the subject of the qualifying clinical trial when it is not otherwise covered outside the clinical trial; items/services provided solely to satisfy protocol data collection and analysis needs that are not used in direct clinical management (for example, lab tests or imaging at protocol‑dictated frequency not consistent with signs/symptoms or standards of care); and items/services provided free of charge by research sponsors. Participant support costs listed in the referenced code group — S9992 (transportation), S9994 (lodging), and S9996 (meals) — are explicitly listed as Not Covered.

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