CurrentDHAPolicy C7S24_5

NIH Clinical Trials for Rare Diseases, Severely Debilitating Conditions, and Life-Threatening Conditions

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

Policy Summary

PayerDHA

PolicyNIH Clinical Trials for Rare Diseases, Severely Debilitating Conditions, and Life-Threatening Conditions

Policy CodePolicy C7S24_5

Change TypeNo material change

Effective DateAug 27, 2025

Next Review DateN/A

Key ActionPreauthorization is required before the initial evaluation for proposed treatment in an eligible NIH-sponsored or NIH-approved clinical trial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Phase I-IVEligible clinical trial phases

<200,000Rare disease prevalence limit

Routine careEligible care category

Phase 0Excluded trial phase

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CurrentDHAPolicy C7S24_5

NIH Clinical Trials for Rare Diseases, Severely Debilitating Conditions, and Life-Threatening Conditions

Customize your policy alerts

Sign up for DHA Policy C7S24_5 alerts

Get alerted when Policy C7S24_5 changes without checking for updates manually.

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

Policy Summary

PayerDHA

PolicyNIH Clinical Trials for Rare Diseases, Severely Debilitating Conditions, and Life-Threatening Conditions

Policy CodePolicy C7S24_5

Change TypeNo material change

Effective DateAug 27, 2025

Next Review DateN/A

Key ActionPreauthorization is required before the initial evaluation for proposed treatment in an eligible NIH-sponsored or NIH-approved clinical trial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Phase I-IVEligible clinical trial phases

<200,000Rare disease prevalence limit

Routine careEligible care category

Phase 0Excluded trial phase

Special claim processing code

Eligibility and Exclusions

Eligibility and covered routine care

Covered when all applicable requirements are met.

Eligible NIH clinical trial coverage

Patient and trial eligibility
- Patient status: The patient is TRICARE-eligible and has been 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.
Protocol requirements
- Allowed phase: The protocol is NIH-sponsored or NIH-approved and is Phase I, Phase II, Phase III, or Phase IV.Phase I-IV
  Phase 0 is excluded.
- Study design: The clinical trial is interventional and studies a specific treatment rather than being observational or limited to disease pathology or population health.Interventional
- Patient continues to qualify: The patient continues to meet the entry criteria for the protocol.
- Provider status: The institutional and individual providers are TRICARE-authorized providers.
Covered services: The requested services and supplies are routine medical care required to determine trial eligibility or required as a result of participation, including eligible follow-up care and testing after active protocol treatment.
Services must not be otherwise reimbursed through an NIH grant or provided in the NIH Clinical Center.

Care rendered in the NIH Clinical Center or care paid in full through an NIH grant program is excluded from TRICARE cost-sharing.

Phase 0 clinical trials are excluded from coverage.

Observational studies and studies limited to the pathology of the disease or condition, or to population-health impacts of the disease or condition, are excluded.

Clinical trials studying treatments that would otherwise be excluded by statute or regulation are not covered, including trials involving exercise programs or cosmetic procedures.

Costs associated with non-treatment research activities and care that is not routine care are excluded. Examples include data collection, data management and analysis, research nurse salaries, and the cost of investigational agents or investigational methods. These research costs are not the responsibility of beneficiaries participating in the clinical trial.

Any service or supply provided free of charge under the investigational protocol is excluded from coverage.

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.

Claims and Special Processing

Special claim processing codeModifier

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

Authorization, Documentation, and Denial Risks

Prior Authorization

Preauthorization Before Initial Evaluation

Obtain preauthorization for the proposed treatment before the patient's initial evaluation for an eligible NIH-sponsored or NIH-approved clinical trial. Retroactive authorization may be available only as permitted under 32 CFR 199.4(g)(19).

Documentation Required

Required Preauthorization Documentation

Submit preauthorization documentation that identifies the patient and establishes the trial's NIH status, the patient's protocol eligibility, and the obligation to report any subsequent loss of eligibility before treatment.

Patient's name and the last four digits of the sponsor's Social Security Number (SSN).
Certification that the protocol is NIH-sponsored or NIH-approved, including the protocol title, ClinicalTrials.gov ID, and/or other appropriate evidence of NIH sponsorship or approval.
Certification that the patient meets all entry criteria for the protocol.

Policy Purpose and Scope

The policy supports TRICARE cost-sharing for routine care associated with qualifying NIH-sponsored or NIH-approved interventional clinical trials conducted in Phase I, Phase II, Phase III, or Phase IV. The trial must study a novel treatment or cure, or treatment for an uncontrolled symptom or aspect of a qualifying rare, severely debilitating, or life-threatening condition. Covered routine care may include eligibility testing, monitoring, treatment of adverse effects, follow-up after active protocol treatment, and conventional services associated with a modified investigational treatment; investigational agents, investigational methods, and research-only costs are excluded.

Key Policy Terms

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 organizationAn NIH Center or Institute.

Oversight scopeThe NIH Center or Institute may be involved in initiating, funding, managing, or 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 and/or analysis of its results.

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

Policy Summary

PayerDHA

PolicyNIH Clinical Trials for Rare Diseases, Severely Debilitating Conditions, and Life-Threatening Conditions

Policy CodePolicy C7S24_5

Change TypeNo material change

Effective DateAug 27, 2025

Next Review DateN/A

Key ActionPreauthorization is required before the initial evaluation for proposed treatment in an eligible NIH-sponsored or NIH-approved clinical trial.

SourceLink

On This Page

Preauthorization: The provider obtains preauthorization before the initial evaluation.Before initial evaluation

Certification that the contractor will be notified if the patient becomes ineligible before treatment.

Documentation Required

Verify NIH Sponsorship or Approval

Verify that the trial is NIH-sponsored or NIH-approved. ClinicalTrials.gov is a useful source but is not conclusive: if status cannot be established there, obtain verification from NIH, the sponsoring or collaborating NIH Center or Institute, the trial investigators, or the provider submitting the authorization; overseas trials require verification under the specified contractor procedures.

An NIH Center or Institute must be listed as the trial sponsor or collaborator on the study-specific ClinicalTrials.gov website, or equivalent NIH verification must be obtained.
Do not deny a beneficiary claim based solely on information obtained from ClinicalTrials.gov.
When eligibility is uncertain, providers, contractors, and beneficiaries may contact NIH, the relevant NIH Center or Institute, or the principal investigators directly.

Denial Risk

Trial Eligibility Failures

Coverage is denied when the clinical trial fails the benefit's eligibility requirements, including the required sponsorship, approval, study design, phase, treatment focus, or condition criteria.

The trial is not NIH-sponsored or NIH-approved, including an industry-sponsored trial with no NIH Center or Institute listed as sponsor or collaborator.
The study is Phase 0, observational, or limited to disease pathology or population-health impacts rather than an interventional study of a specific treatment.
The trial does not study a novel treatment or cure for a specific condition, or treatment of a currently uncontrolled symptom or aspect of that condition.
The condition is not severely debilitating, life-threatening, or a rare disease; examples of generally ineligible conditions include acne, acute bronchitis, allergic rhinitis, norovirus, oral candidiasis, ringworm, rosacea, scabies, streptococcal infections, and tinnitus.
The treatment, if proven effective, would otherwise be excluded by statute or regulation, such as exercise programs or cosmetic procedures.

Denial Risk

Missing Authorization or Provider Eligibility

Do not submit or expect cost-sharing unless preauthorization was obtained before initial evaluation, the patient continues to meet the protocol's entry criteria, and both the institutional and individual providers are TRICARE-authorized. Services and supplies must also independently satisfy the policy requirements.

Missing required preauthorization may result in denial, subject to any retroactive authorization permitted under 32 CFR 199.4(g)(19).
Notify the contractor if the patient becomes ineligible before treatment; continued protocol eligibility is required.
Institutional and individual providers must be TRICARE-authorized.
Normal TRICARE eligibility, reimbursement, copayment, cost-share, deductible, TRICARE for Life, and double-coverage rules continue to apply.

Billing Rule

Excluded Research and No-Cost Services

TRICARE cost-shares routine care otherwise covered during treatment, eligibility screening, monitoring, follow-up, and management of treatment-related effects, but not research costs or services furnished without charge. Investigational agents and methods are excluded when they are sponsor-funded or solely part of the investigational treatment.

Excluded research activities include data collection, data management and analysis, research-nurse salaries, and other non-treatment research costs; these costs are not the beneficiary's responsibility.
Do not cost-share care rendered in the NIH Clinical Center or paid in full through an NIH grant program.
Do not cost-share any service or supply provided free of charge under the investigational protocol.
Investigational devices, agents, methods, and other items that are solely part of the investigational treatment are not covered; approved pharmaceutical drugs are covered except for sponsor-funded investigational agents.

Denial Risk

Protocol Enrollment Ineligibility

If a patient does not meet the enrollment or protocol eligibility criteria for a specific clinical trial, the DoD has no authority over that protocol's eligibility and appeal rights do not apply. This limitation concerns trials not sponsored or approved by the DoD.

Confirm and certify that the patient meets all protocol entry criteria before treatment.
Notify the contractor if the patient becomes ineligible for the study before treatment.
The absence of appeal rights for protocol enrollment ineligibility does not replace the provider's preauthorization and documentation obligations.

ClinicalTrials.gov designationIdentification of the NIH Center or Institute as a collaborator on the ClinicalTrials.gov website for the specific clinical trial constitutes NIH approval.

Rare disease

DefinitionA disease or condition with a prevalence of fewer than 200,000 persons.

U.S. prevalence thresholdFewer than 200,000 persons in the United States.

Geographic scopeThe prevalence threshold applies to the United States.

Severely debilitating condition

DefinitionA disease or medical condition that causes major irreversible morbidity.

Existing treatmentExisting treatments may manage certain aspects of the condition.

Curative treatmentNo curative treatment exists for aspects of the disease 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.

Potentially fatal outcomesThe term also includes diseases or conditions with potentially fatal outcomes.

Clinical trial endpointThe condition qualifies when survival is the endpoint of clinical trial analysis.

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.

Possible basisExisting treatment may have a relatively low probability of successfully treating the specific condition or may be only palliative.

Not sufficient by itselfThe term does not mean merely that harmful side effects may occur or that a treatment has a possibility of failure.

Routine care

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

Eligibility and monitoringCovered routine care includes screening tests to determine clinical trial eligibility, examinations, imaging, and blood tests to monitor or assess patient health during the trial.

Side-effect managementRoutine care includes TRICARE-covered drugs and other medically necessary care used to treat treatment side effects or manage other aspects of a patient's medical treatment.

Frequency and magnitudeRoutine care may differ in frequency and magnitude from care provided in the absence of the investigational treatment.

Excluded investigational servicesTRICARE does not cover the investigational device or services and supplies solely part of the investigational treatment or provided at no cost to beneficiaries.