CurrentColorado Rocky Mountain Health PlansPolicy CS018SS.U

Mandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials

Defines payer coverage of routine patient costs associated with qualifying clinical trials and the conditions under which such costs are covered for members subject to federal, state, or contractual requirements. Affects providers submitting claims for clinical trial–related services and Medicaid members participating in qualifying trials.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMandatory Medicaid Coverage of Routine Patient Costs in Qualifying Clinical Trials

Policy CodePolicy CS018SS.U

Change TypeTemplate update; medical records language added

Effective DateSeptember 1, 2025

Next Review Date

Key ActionSubmit a provider/principal investigator attestation using the Secretary's standardized form when requesting coverage determinations for routine patient costs.

SourceLink

POLICY UPDATE CHANGES

Template update and removal of content/language pertaining to the state of Louisiana.

Medical records documentation language added clarifying that records may be required to assess coverage but do not guarantee coverage.

Severalcodes referenced

Multiplecovered service examples

Federalstatutory basis

Coverage for Routine Patient Costs in Qualifying Clinical Trials

Coverage for Routine Patient Costs

Covered when ALL of the following are met:

Qualified Clinical Trial description: The study must meet one of the following: (1) approved, conducted, or supported by NIH (including NCI), CDC, AHRQ, CMS, a cooperative group or center of such entities, or a qualified non‑governmental research entity; or (2) reviewed and approved through a peer‑review system for DoD/VA/DOE studies determined by the Secretary to meet NIH‑comparable standards; or (3) conducted under an investigational new drug exemption (section 505(i)) or an equivalent biologics exemption; or (4) a drug trial exempt from those exemption requirements.

From Indications for Coverage Criteria for Qualified Clinical Trials

Trial phase and purpose: The trial is Phase I, Phase II, Phase III, or Phase IV and is conducted in relation to the prevention, detection, or treatment of a serious or life‑threatening disease or condition, and it meets the requirements for a Qualified Clinical Trial.

Defined as Phase I–IV and related to serious or life‑threatening conditions

Covered routine patient costs: Any item or service provided to the individual under the qualifying clinical trial that would otherwise be covered outside the trial, including items and services to prevent, diagnose, monitor, or treat complications resulting from participation, and any item or service required solely for provision of the investigational item or service (including administration). Examples include physician services, laboratory services, and medical imaging services.

Covered Routine Patient Costs During Qualified Clinical Trials

Routine patient costs associated with participation in a qualifying clinical trial are excluded when they meet any of the following conditions: the item or service is the investigational item or service that is the subject of the qualifying Clinical Trial and is not otherwise covered outside the trial; the item or service is provided free of charge by the research sponsor; or the service is performed solely to satisfy study data collection and analysis requirements and is not used in the member’s direct clinical management. Refer to applicable federal, state, and contractual requirements for additional details.

Services furnished only to meet protocol-driven data collection or analysis and that are not used in direct clinical management are not considered routine patient costs. Examples include laboratory tests or imaging performed at frequencies required by the study protocol that are inconsistent with signs, symptoms, or standard of care for the diagnosis or treatment. Such services may be excluded from coverage even when provided during a qualifying trial.

Applicable Modifiers, CPT/HCPCS, and Diagnosis Codes

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.

Clinical Trial Modifiers (note)Modifier

No codes listed

Applicable HCPCS/CPT/Local 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.

Diagnosis CodesICD-10

Z00.6

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

Attestation, Documentation, and Claim Denial Triggers

Documentation Required

Attestation Required

Coverage determinations will be based on an attestation regarding the appropriateness of the Clinical Trial by the health care provider and principal investigator, using the Secretary's streamlined, uniform attestation form. The form may reference publicly available trial information (for example, clinicaltrials.gov).

Provider/principal investigator must complete Secretary’s standardized attestation form
Attestation may reference public trial registry information

Documentation Required

Medical Records May Be Required

Medical records documentation may be requested to determine whether the member meets applicable federal, state, or contractual criteria for coverage. Submission of records to support the attestation and clinical criteria is required when requested and does not alone guarantee coverage.

Clinical Trials Background

Clinical trials are structured research studies that evaluate interventions (drugs, devices, procedures, or behavioral strategies) in human volunteers to determine safety and effectiveness. Trials proceed through defined phases (for example, Phase I–IV) and may generate protocol‑driven procedures and tests; routine patient costs include those services that would otherwise be covered outside the trial, while investigational items or protocol‑only data collection activities may be excluded.

Clinical Trial Phases and Qualifying Trial Definition

Clinical trial phases and qualifying trial definition

Early Phase 1 (formerly Phase 0)Exploratory trials before traditional Phase 1 with very limited human exposure, no therapeutic or diagnostic goals (e.g., screening or microdosing studies).

Phase 1Trials focusing on safety, usually with healthy volunteers to determine frequent/serious adverse events and pharmacokinetics; typically small participant numbers.

Phase 2Trials that gather preliminary data on effectiveness in people with the condition; may compare the drug to placebo or another treatment while continuing safety evaluation.

Phase 3Larger trials that gather more information about safety and effectiveness across populations and dosages and in combination with other drugs.

Phase 4Post‑marketing trials conducted after FDA approval, including required or agreed post‑market studies to gather additional safety, efficacy, or optimal‑use information.