CurrentIndiana Department of InsurancePolicy PROMOD00060

Clinical Trials

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This policy governs Indiana Health Coverage Programs fee-for-service coverage of routine costs for members participating in qualifying clinical trials. It distinguishes covered routine costs from noncovered nonroutine costs and establishes coverage determination and prior authorization procedures; managed care providers must consult the member's managed care entity or applicable provider manual.

Policy Summary

PayerIndiana Department of Insurance

PolicyClinical Trials

Policy CodePolicy PROMOD00060

Change TypeAdministrative/editorial clarification

Effective DateAug 1, 2025

Next Review DateNot specified

Key ActionProviders must determine whether the underlying routine service has a prior authorization requirement.

SourceLink

POLICY UPDATE CHANGES

The current revision edited text for clarity, added Indiana PathWays information to the introductory note, and corrected United States Code references.

72 hoursClinical trial determination timeframe

Routine costsCovered cost category

Nonroutine costsExcluded cost category

Not requiredProtocol submission

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CurrentIndiana Department of InsurancePolicy PROMOD00060

Clinical Trials

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Sign up for Indiana Department of Insurance Policy PROMOD00060 alerts

Get alerted when Policy PROMOD00060 changes without checking for updates manually.

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Policy Summary

PayerIndiana Department of Insurance

PolicyClinical Trials

Policy CodePolicy PROMOD00060

Change TypeAdministrative/editorial clarification

Effective DateAug 1, 2025

Next Review DateNot specified

Key ActionProviders must determine whether the underlying routine service has a prior authorization requirement.

SourceLink

POLICY UPDATE CHANGES

The current revision edited text for clarity, added Indiana PathWays information to the introductory note, and corrected United States Code references.

72 hoursClinical trial determination timeframe

Routine costsCovered cost category

Nonroutine costsExcluded cost category

Not requiredProtocol submission

Clinical Trial Coverage Criteria

Requirements for a qualifying clinical trial

A clinical trial is qualifying when all of the following are met, including at least one qualifying pathway.

Qualifying clinical trial

Qualifying pathway
- Government or qualified entity support: The study or investigation is approved, conducted, or supported, including funded, by one or more of the NIH, CDC, AHRQ, CMS, a cooperative group or center of those entities, the Department of Defense, the Department of Veterans Affairs, or a qualified nongovernmental research entity identified in NIH guidelines for center support grants.
- Comparable peer review and specified federal approval or funding: The clinical trial has been reviewed and approved through a peer-review system comparable to NIH peer review that assures unbiased review to the highest scientific standards by qualified individuals without an interest in the outcome, and the trial is approved or funded by the Department of Veterans Affairs, Department of Defense, or Department of Energy.
- Investigational exemption: The clinical trial is conducted under an investigational new drug exemption under section 355(i) of Title 21 of the United States Code or an exemption for a biological product under section 262(a)(3) of Title 42 of the United States Code.
- Exempt drug trial: The clinical trial is a drug trial exempt from having an investigational new drug application.

Covered routine costs

Routine costs are covered when all of the following are true.

Routine cost coverage: The item or service is provided to a member participating in a qualifying clinical trial; a benefit category exists and the item or service is not listed as noncovered in the Indiana Administrative Code; and the item or service would otherwise be covered outside the clinical trial.

Existing coverage rules and regulations continue to apply, including when the investigational item or service is otherwise covered.

Examples of reimbursable routine costs

Examples of reimbursable routine costs include the following when they meet the routine-cost coverage standard.

Examples of covered routine services: The cost is for an otherwise covered service, an item or service required to administer or provide the investigational item or service, clinically appropriate monitoring, prevention of complications, or reasonable and necessary diagnosis or treatment of complications.

Examples include nursing or staffing fees; patient monitoring and evaluation; durable medical equipment; intravenous or catheter line placement; administration fees; equipment and ancillary staffing for implantation of an investigational device; nebulizers; required room and board; ECGs; EEGs; blood pressure monitoring; antinausea medication; and treatment of pneumonia caused by an investigational lung procedure.

Investigational items or services are not covered unless they would otherwise be covered outside the clinical trial. When an item or service is covered only for specified medical conditions, it is not reimbursable if the trial tests it outside that existing coverage scope.

Research-only items or services are excluded when they are provided solely to satisfy data collection or analysis requirements and are not used for the patient’s direct clinical management.

Sponsor-provided items or services are excluded when the research sponsor customarily provides them free of charge to any enrollee in the clinical trial.

Determinations, Authorization, and Documentation

Prior Authorization

Expedited Clinical Trial Determination

IHCP coverage determinations for costs related to a qualifying clinical trial are expedited and completed within 72 hours. Determinations are made without limitation based on the geographic location or network affiliation of the healthcare provider treating the individual or the principal investigator.

Prior Authorization

Apply Standard Service PA Rules

Prior authorization requirements that apply to services provided outside a clinical trial also apply to routine services within a clinical trial. Review the appropriate IHCP provider reference module for procedure- or treatment-specific requirements.

See the IHCP Provider Reference Modules webpage at in.gov/medicaid/providers for specific PA requirements.

Prior Authorization

PA Depends on the Underlying Service

Clinical Trial Coverage Context

A clinical trial is a human research study designed to answer specific health questions and evaluate new uses, safety, or effectiveness of treatments, drugs, devices, and procedures. For an IHCP member participating in a qualifying clinical trial, coverage focuses on routine costs that would otherwise be covered outside the trial, including services used to prevent, diagnose, monitor, or treat complications of trial participation.

Key Terms

Clinical trial

Study typeA research study among human volunteers.

PurposeTo answer specific health questions.

Treatments and technologies evaluatedNew uses, safety, or effectiveness of treatments, drugs, devices, or procedures.

Qualifying clinical trial

Development phaseA clinical trial in any clinical phase of development.

Disease or conditionConducted in relation to the prevention, detection, or treatment of a serious or life-threatening disease or condition.

Qualifying pathway

Policy Summary

PayerIndiana Department of Insurance

PolicyClinical Trials

Policy CodePolicy PROMOD00060

Change TypeAdministrative/editorial clarification

Effective DateAug 1, 2025

Next Review DateNot specified

Key ActionProviders must determine whether the underlying routine service has a prior authorization requirement.

SourceLink

On This Page

Determine whether prior authorization is required based on the underlying service or procedure. A service does not avoid PA solely because it is furnished as part of a clinical trial.

Apply the standard PA rules for the particular service provided outside the trial.
Routine trial services remain subject to applicable service-specific PA requirements.

Documentation Required

Complete the Clinical Trial Attestation

For a qualifying clinical trial, the healthcare provider and principal investigator must attest to the appropriateness of the trial using the required Medicaid form. The provider must keep the completed attestation on file.

Use the Medicaid Attestation Form on the Appropriateness of the Qualified Clinical Trial.

Documentation Required

Limit Trial Documentation Requests

Coverage determinations are completed without requiring submission of the qualifying clinical trial protocol or other documentation that is proprietary or determined by the HHS Secretary to be burdensome to provide.

Do not require the trial protocol for the coverage determination.
Do not require burdensome proprietary documentation.

Denial Risk

Investigational Service Outside Coverage

An investigational item or service is not a covered routine clinical-trial cost unless it would otherwise be covered outside the trial. Deny reimbursement when the item or service is being tested for a use outside the scope of its existing coverage.

If the item or service is covered only for certain medical conditions, it is not reimbursable when tested for an uncovered condition or use.

Denial Risk

Research-Only Services

Items and services provided solely to satisfy data collection or analysis needs are noncovered when they are not used in the direct clinical management of the patient.

Examples include monthly CT scans when only one scan is usually required.
Weekly blood draws not needed to monitor side effects are noncovered.
Quarterly Pap smears when annual screening is usually required are noncovered.

Denial Risk

Sponsor-Provided Services

Items and services customarily furnished free of charge by the research sponsor for any enrollee in the trial are noncovered and should not be reimbursed by the IHCP.

Confirm whether the research sponsor customarily provides the item or service at no cost to trial enrollees.

Documentation Required

Confirm the Trial Qualifies

Before applying clinical-trial coverage rules, confirm that the study is a qualifying clinical trial and obtain the required provider and principal investigator attestation. The trial must concern prevention, detection, or treatment of a serious or life-threatening disease or condition and satisfy an accepted approval, funding, peer-review, investigational-new-drug, or drug-trial exemption pathway.

Qualifying pathways include approval, conduct, or support by specified federal agencies or qualified research entities; comparable NIH-level peer review with qualifying federal funding; an applicable investigational new drug or biological-product exemption; or a qualifying drug-trial exemption.
Keep the completed Medicaid Attestation Form on file with the provider.

Meets at least one qualifying pathway: support or approval by specified government or qualified entities; comparable peer review with specified federal approval or funding; an investigational new drug or biological product exemption; or exemption from an investigational new drug application for a drug trial.

Routine cost

Covered trial-related item or serviceAny item or service provided to an individual under a qualifying clinical trial, including services to prevent, diagnose, monitor, or treat complications resulting from participation.

Existing coverage requirementThe item or service must otherwise be covered outside the clinical trial, meaning a benefit category exists and the item or service is not listed as noncovered in the Indiana Administrative Code.

ExamplesRoutine costs may include nursing or staffing fees, patient monitoring and evaluation, durable medical equipment, IV or catheter line placement, administration services, monitoring tests, prevention of complications, and diagnosis or treatment of complications.

Nonroutine cost

Investigational item or serviceAn investigational item or service that is not otherwise covered outside the clinical trial, including one tested outside the coverage scope for specified medical conditions.

Research-only serviceAn item or service provided solely to satisfy data collection or analysis needs and not used in the direct clinical management of the patient.

Sponsor-provided costAn item or service customarily provided free of charge by the research sponsor for any trial enrollee.