CurrentDHAPolicy 6010.60-M

NIH Clinical Trials for Serious Conditions

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Coverage criteria for routine care associated with qualifying NIH-sponsored or NIH-approved interventional clinical trials for rare, severely debilitating, or life-threatening conditions.

Policy Summary

PayerDHA

PolicyNIH Clinical Trials for Serious Conditions

Policy CodePolicy 6010.60-M

Change TypeNo material change

Effective DateAugust 27, 2025

Next Review DateNot specified

Key ActionObtain preauthorization before the patient's initial evaluation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

I–IVEligible trial phases

Phase 0Excluded trial phase

<200,000Rare disease threshold

Routine careCovered service category

CQClaims processing code

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CurrentDHAPolicy 6010.60-M

NIH Clinical Trials for Serious Conditions

Customize your policy alerts

Sign up for DHA Policy 6010.60-M alerts

Get alerted when Policy 6010.60-M changes without checking for updates manually.

Monitor payer policy activity

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Coverage criteria for routine care associated with qualifying NIH-sponsored or NIH-approved interventional clinical trials for rare, severely debilitating, or life-threatening conditions.

Policy Summary

PayerDHA

PolicyNIH Clinical Trials for Serious Conditions

Policy CodePolicy 6010.60-M

Change TypeNo material change

Effective DateAugust 27, 2025

Next Review DateNot specified

Key ActionObtain preauthorization before the patient's initial evaluation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

I–IVEligible trial phases

Phase 0Excluded trial phase

<200,000Rare disease threshold

Routine careCovered service category

CQClaims processing code

NIH Clinical Trial Coverage Criteria

Eligibility for NIH clinical trial coverage

Coverage is authorized when all applicable requirements are met.

Qualifying NIH clinical trial and patient

Patient eligibility
- The patient is TRICARE-eligible and selected to participate in the clinical trial.
Qualifying condition
- The trial studies a rare disease, a severely debilitating condition, or a life-threatening condition.
Trial objective
- The trial studies a novel treatment or cure for a specific condition, or treatment of a currently uncontrolled symptom or aspect of that condition.
Eligible trial phase
- The protocol is Phase I, Phase II, Phase III, or Phase IV.Phase I-IV
  Phase 0 trials are excluded.
Protocol characteristics
- The trial is interventional rather than observational and studies a specific treatment; the patient continues to meet the protocol entry criteria; preauthorization is obtained before initial evaluation; and the institutional and individual providers are TRICARE-authorized.

Covered routine care

TRICARE cost-shares covered routine care associated with an eligible clinical trial.

Covered services and supplies

The service or supply is routine medical care required to determine trial eligibility, provided during participation, or required follow-up care and testing after active protocol treatment; it is not otherwise reimbursed by an NIH grant or provided in the NIH Clinical Center; and it would otherwise be covered by TRICARE during the normal course of treatment.
Covered categories may include approved non-investigational drugs, inpatient and outpatient care, diagnostic and laboratory services, rehabilitation, home health, examinations, imaging, blood tests, treatment of side effects, and other medically necessary care.

Routine care for modified treatment modalities

Routine services may be covered even when their frequency or magnitude increases because of the investigational treatment.

Modified conventional care

When the investigational therapy modifies a treatment modality also used in conventional therapy, TRICARE may cost-share the routine services and supplies that would have been covered for the conventional therapy.
The investigational device and services or supplies solely part of the investigational treatment remain excluded.

Excluded care includes care rendered in the NIH Clinical Center or care paid in full through an NIH grant program.

Phase 0 clinical trials are excluded from coverage under this benefit. Eligible trial phases are addressed separately by the policy.

Coverage excludes studies that are observational or that only examine disease pathology, the condition itself, or population-health effects associated with the disease or condition.

Coverage excludes clinical trials studying treatments that would remain excluded by statute or regulation even if proven effective, including exercise programs and cosmetic procedures.

Non-treatment research activities are excluded, including data collection, data management and analysis, research nurse salaries, investigational agents, and investigational methods. These research costs are not the responsibility of beneficiaries participating in the clinical trial.

Coverage excludes the investigational device and any service or supply solely associated with the investigational treatment. Services or supplies provided free of charge under the investigational protocol are also excluded.

TRICARE does not cost-share care provided at no cost to individuals enrolled in other health plans.

Studies that do not meet the policy requirements are excluded. This includes, for example, industry-sponsored clinical trials in which no NIH Center or Institute is listed as a sponsor or collaborator.

Services, supplies, or costs are not eligible for cost-sharing when they are not routine care or are solely associated with non-treatment research or the investigational treatment.

Coding and Trial Classification

Special claims processing codemixed

CQ	Special processing code used to designate a claim is associated with an NIH clinical trial eligible under this section.

Rare disease prevalence

Prevalence thresholdFewer than 200,000 persons

PopulationPersons in the United States

ApplicationDefines the prevalence threshold for a rare disease

Authorization, Documentation, and Denial Conditions

Prior Authorization

Preauthorization Before Initial Evaluation

Obtain preauthorization for the proposed treatment before the patient's initial evaluation. Retroactive authorization may be granted only in accordance with 32 CFR 199.4(g)(19); it is not automatic.

Documentation Required

Required Preauthorization Contents

The contractor must verify that the clinical trial is NIH-sponsored or approved, studies an eligible treatment or cure for a qualifying condition, and otherwise meets all requirements of this section. The provider's preauthorization must support the trial's eligibility, the patient's protocol eligibility, and compliance with applicable policy requirements.

Documentation Required

Policy Background

The benefit supports routine care connected with NIH-sponsored or NIH-approved interventional clinical trials studying a novel treatment or cure for a specific rare, severely debilitating, or life-threatening condition, or treatment of an uncontrolled symptom or aspect of that condition. Covered routine care may include eligibility evaluation, monitoring, treatment of adverse effects, medically necessary services, and follow-up after active protocol treatment. Investigational treatment costs and other research-only expenses remain excluded.

Key Policy Definitions

NIH-sponsored clinical trial

DefinitionA clinical trial in which an NIH Center or Institute initiates, funds, manages, and otherwise oversees the clinical trial, in whole or in part.

Responsible entityAn NIH Center or Institute

Oversight activitiesInitiating, funding, managing, and otherwise overseeing the trial

NIH-approved clinical trial

DefinitionA clinical trial in which an NIH Center or Institute collaborates with the study sponsor to provide resources or other support toward development of the clinical trial or analysis of its results.

Types of supportSupport may include funding, design, implementation, data analysis, or reporting.

Policy Summary

PayerDHA

PolicyNIH Clinical Trials for Serious Conditions

Policy CodePolicy 6010.60-M

Change TypeNo material change

Effective DateAugust 27, 2025

Next Review DateNot specified

Key ActionObtain preauthorization before the patient's initial evaluation.

SourceLink

On This Page

Verify Overseas Trials

Overseas clinical trials may qualify for coverage, but requests for coverage of treatment in an overseas trial must be verified for NIH sponsorship or approval using the procedures in paragraph 3.6.1. If ClinicalTrials.gov does not establish the status, the contractor must seek confirmation through NIH, the investigators, or the submitting provider.

Unsupported block type: documentation

Documentation Required

Document NIH Sponsorship or Approval

Submit evidence that the trial is NIH-sponsored or approved, including certification, the protocol title, the ClinicalTrials.gov identification number, and/or other appropriate supporting evidence.

Documentation Required

Certify Patient Eligibility

Certify that the patient meets all entry criteria for the protocol and notify the contractor if the patient becomes ineligible before treatment.

Billing Rule

Support Routine-Care Claims

Claims and submitted services or supplies must support that the charges are eligible routine care associated with the qualifying clinical trial. Routine care may include otherwise covered examinations, imaging, laboratory tests, treatment of side effects, and medically necessary supplies, even when monitoring is more frequent because of the investigational treatment.

TRICARE will not cost-share the investigational device, investigational agents or methods, services provided at no cost, or care provided at no cost to individuals enrolled in other health plans.

Denial Risk

Trial Eligibility Is Required

Coverage may be denied when the trial does not meet eligibility requirements, including NIH sponsorship or approval, an eligible trial phase, an interventional study of a specific treatment, or the qualifying disease and treatment requirements.

Phase 0 trials are excluded.
Observational studies and studies limited to disease pathology or population health are excluded.
Trials not meeting the section's requirements, including certain industry-sponsored trials without an NIH sponsor or collaborator, are excluded.

Denial Risk

Separate Non-Routine or Funded Costs

Do not submit non-routine research costs as covered routine care. Coverage is not available for investigational agents or methods, non-treatment research activities, care or supplies provided free under the protocol, or costs separately funded through an NIH grant or provided in the NIH Clinical Center.

Non-treatment research activities include data collection, data management and analysis, research nurse salaries, and investigational agents or methods.
Services and supplies must meet the policy's routine-care requirements to qualify for cost-sharing.

Denial Risk

Meet Authorization and Provider Requirements

Coverage may be denied when preauthorization was not obtained before the initial evaluation, the patient does not meet protocol entry criteria, the trial fails an eligibility requirement, or the institutional or individual provider is not TRICARE-authorized. Retroactive authorization is limited to the circumstances permitted by 32 CFR 199.4(g)(19).

Denial Risk

Patient Must Be Eligible for the Protocol

A patient who does not meet the eligibility criteria for enrollment in the specific clinical-trial protocol does not qualify for coverage under this benefit. Because the DoD has no authority over protocol eligibility for trials not sponsored or approved by the DoD, appeal rights do not apply to that determination.

NIH approvalIdentification of the NIH Center or Institute as a collaborator on the specific clinical trial's ClinicalTrials.gov website constitutes NIH approval.

Rare disease

DefinitionAny disease or condition with a prevalence of fewer than 200,000 persons in the United States.

ThresholdFewer than 200,000 persons

Geographic scopeThe prevalence is measured in the United States.

Severely debilitating condition

DefinitionA disease or medical condition that causes major irreversible morbidity.

Existing treatmentsExisting treatments may manage certain aspects of the condition.

Curative treatmentThere may be no curative treatment for aspects that severely decrease the patient's health and quality of life.

Life-threatening condition

DefinitionA disease or condition in which the likelihood of death is high unless the course of the disease is interrupted.

Potential outcomeIncludes diseases or conditions with potentially fatal outcomes.

Clinical trial endpointThe endpoint of clinical trial analysis may be survival.

Uncontrolled

DefinitionA symptom or aspect of a specific condition that cannot be effectively managed or cured with existing medications, durable medical equipment, surgery, or other treatments or therapies.

Examples of inadequate treatmentExisting treatment may have a high likelihood of harmful side effects, a relatively low probability of successfully treating the specific condition, or only palliative benefit.

Exclusion from definitionThe term does not mean merely that harmful side effects could occur or that a specific treatment could fail.

Routine care

DefinitionSupplies, services, and treatments that TRICARE otherwise would have covered during the normal course of treatment.

Included careIncludes screening tests for clinical trial eligibility, examinations, imaging, blood tests, and medically necessary drugs or care, including treatment of side effects.

Frequency or magnitudeRoutine care may differ in frequency and magnitude because of the investigational treatment.