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    v1.0.30
    OpenPayerPolicy UpdatesTransplantDHA Infectious Disease Trial Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentDHAPolicy 6010.60-M

    Infectious Disease Health Emergency Clinical Trials

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    TRICARE medical coverage for routine care associated with eligible NIH-sponsored or NIH-approved interventional clinical trials addressing a government-recognized infectious disease health emergency or associated sequelae.

    Policy Summary
    PayerDHA
    PolicyInfectious Disease Health Emergency Clinical Trials
    Policy CodePolicy 6010.60-M
    Change TypeNo material change
    Effective DateAug 27, 2025
    Next Review DateN/A
    Key ActionObtain preauthorization before the patient's initial evaluation.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Phase I-IVEligible clinical trial phases
    5Core coverage conditions
    7Exclusion categories
    CRSpecial processing code
    24.4Policy section

    Eligible Clinical Trial Coverage

    Eligible Infectious Disease Emergency Clinical Trial Coverage

    Coverage is authorized when <strong>all</strong> applicable requirements below are met.

    ALL of the following

    • The patient is TRICARE-eligible and selected to participate in the clinical trial.

    • The trial is an eligible phase

      • NIH-sponsored or approved Phase I clinical trial.
      • NIH-sponsored or approved Phase II clinical trial.
      • NIH-sponsored or approved Phase III clinical trial.
    Policy Summary
    PayerDHA
    PolicyInfectious Disease Health Emergency Clinical Trials
    Policy CodePolicy 6010.60-M
    Change TypeNo material change
    Effective DateAug 27, 2025
    Next Review DateN/A
    Key ActionObtain preauthorization before the patient's initial evaluation.
    SourceLink
    On This Page
    Eligible Clinical Trial CoverageClaims Processing CodeAuthorization and Trial VerificationPolicy ContextKey Policy Terms

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    NIH-sponsored or approved Phase IV clinical trial.

  1. The trial studies one or more of the following

    • Prevention of a Government-recognized infectious disease health emergency or associated sequelae.
    • Screening for a Government-recognized infectious disease health emergency or associated sequelae.
    • Early detection of a Government-recognized infectious disease health emergency or associated sequelae.
    • Treatment of a Government-recognized infectious disease health emergency or associated sequelae.
  2. The clinical trial is interventional rather than observational and studies a specific treatment for the infectious disease or a complication of the disease.
  3. The provider seeking treatment has obtained preauthorization for the proposed treatment before the patient's initial evaluation.
  4. The patient continues to meet the entry criteria for the protocol.
  5. The institutional and individual providers are TRICARE-authorized providers.
  6. The Government-recognized infectious disease health emergency is one for which the President of the United States has declared a national emergency or the Secretary of Health and Human Services has declared a Public Health Emergency for a pandemic or epidemic resulting from an infectious disease.

    7. Overseas Clinical Trial Coverage

    Clinical trials conducted overseas may be covered when <strong>all</strong> applicable requirements below are met.

    ALL of the following

    • The clinical trial is conducted in a location overseas.
    • The trial is NIH-sponsored or approved, and the contractor verifies that status using the procedures in paragraph 3.7.1. An NIH Center or Institute must be listed as the trial sponsor or collaborator on the study-specific ClinicalTrials.gov website, or sponsorship or approval must be verified through NIH, the trial investigators, or the provider submitting the prior authorization.
    • The trial studies a treatment for a Government-recognized infectious disease health emergency or associated sequelae and otherwise meets all requirements of this section.

    • The emergency is recognized by an applicable authority

      • The President of the United States has declared a national emergency, or the Secretary of Health and Human Services has declared a Public Health Emergency for a pandemic or epidemic resulting from an infectious disease.
      • For care rendered overseas, the epidemic or pandemic is recognized by a foreign government or the World Health Organization, and the NIH-sponsored or approved clinical trial is located in the region experiencing that Government-recognized epidemic or pandemic.
    • The provider has submitted the required preauthorization, including the patient's name; the last four digits of the sponsor's SSN; protocol title and phase; ClinicalTrials.gov ID or other appropriate evidence of NIH sponsorship or approval; certification that the patient meets all protocol entry criteria; and certification that notification will be provided if the patient becomes ineligible before treatment.
    • All services and supplies submitted for cost-sharing meet the requirements of this section.

    Care rendered in the NIH Clinical Center or paid in full through an NIH grant program is excluded from coverage under this benefit.

    Phase 0 clinical trials are excluded from coverage.

    Observational studies are excluded. Studies that only study the pathology of the infectious disease itself or aspects of population health impacted by the disease are also excluded.

    Clinical trials studying treatments that, even if proven effective, would otherwise be excluded by statute or regulation are excluded. Examples include exercise programs and cosmetic procedures.

    Costs associated with non-treatment research activities related to the clinical trial are excluded, as is care that is not routine care. Non-treatment research activities include, but are not limited to, data collection; data management and analysis; salaries of research nurses; and the cost of investigational agents or investigational methods used in the protocol. These research costs are not the responsibility of beneficiaries participating in the clinical trials.

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

    Studies that do not meet the requirements of this section are excluded, including industry-sponsored clinical trials where no NIH Center or Institute is listed as a sponsor or collaborator. Clinical trials must meet all criteria in this section; an NIH Center or Institute listed as a trial sponsor or collaborator on the study-specific ClinicalTrials.gov website constitutes NIH sponsorship or approval. If sponsorship or approval cannot be ascertained from ClinicalTrials.gov, it may be verified through NIH, the trial investigators, or the provider submitting the prior authorization.

    Coverage is limited to routine care: supplies, services, and treatments that TRICARE otherwise would have covered during the normal course of treatment, including screening tests to determine clinical trial eligibility. Routine care may include examinations, imaging, blood tests to monitor or assess patient health, and drugs TRICARE would cover absent the clinical trial when necessary to treat treatment-related side effects, manage other aspects of the patient's medical treatment, or otherwise provide medically necessary care. Routine care may differ in frequency or magnitude from care provided absent the investigational treatment. Care that is not routine, not medically necessary, or would not otherwise be covered by TRICARE during the normal course of treatment is excluded.

    Claims Processing Code

    Special Processing Codemixed
    CRSpecial processing code used to designate a claim associated with a clinical trial eligible under this section.

    Authorization and Trial Verification

    Prior Authorization

    Preauthorization Required Before Evaluation

    Obtain preauthorization before the beneficiary's initial evaluation for the proposed clinical-trial treatment. The request must identify the patient and sponsor using the patient's name and the last four digits of the sponsor's SSN.

    • Preauthorization is required before initial evaluation, not merely before treatment.
    • Normal TRICARE eligibility, reimbursement, copayments, cost-shares, deductibles, TRICARE for Life, and double-coverage rules still apply.
    Prior Authorization

    Retroactive Authorization

    Retroactive authorization may be authorized when permitted under the applicable regulatory provisions. Apply the procedures and conditions established in 32 CFR 199.4(g)(19).

    • Retroactive authorization is not automatic; the request must satisfy the cited regulation.
    Documentation Required

    Preauthorization Documentation

    Submit complete preauthorization documentation so the contractor can verify the trial, the patient's eligibility, and the services requested. The provider must certify the required protocol and patient information and agree to report any later loss of eligibility.

    • Patient's name and the last four digits of the sponsor's SSN.
    • Certification that the protocol is NIH-sponsored or NIH-approved.
    • Protocol title, protocol phase, ClinicalTrials.gov ID, and/or other appropriate evidence of NIH sponsorship or approval.
    • Certification that the patient meets all protocol entry criteria.
    • Certification that the contractor will be notified if the patient becomes ineligible before treatment.
    Documentation Required

    Verify Trial Sponsorship and Approval

    Verify that the trial is NIH-sponsored or NIH-approved and that it studies treatment for a Government-recognized infectious disease health emergency or associated sequelae. ClinicalTrials.gov evidence is sufficient when an NIH Center or Institute is listed as the study sponsor or collaborator; if the listing is unclear or unavailable, obtain verification through NIH, the relevant NIH Center or Institute, the investigators, or the provider submitting the authorization.

    • Use the study-specific ClinicalTrials.gov record to verify the NIH sponsor or collaborator.
    • Overseas trials may be covered, but their NIH sponsorship or approval must be verified using the same procedures.
    • If eligibility remains uncertain, contact NIH, the sponsoring or collaborating NIH Center or Institute, or the principal investigators.
    • Do not deny a claim solely on the basis of information obtained from ClinicalTrials.gov when sponsorship or approval cannot be ascertained there.
    Denial Risk

    Failure to Meet Eligibility or Authorization Requirements

    Coverage may be denied when the trial or treatment does not satisfy every applicable eligibility and authorization requirement. The trial must be an eligible interventional treatment study, the patient must continue to meet its entry criteria, and both the institutional and individual providers must be TRICARE-authorized.

    • Authorization must be obtained before initial evaluation, subject to any permitted retroactive authorization.
    • The protocol must be NIH-sponsored or NIH-approved and must study a specific treatment for the infectious disease or a complication of the disease.
    • Clinical trials must meet all requirements of the section; failure to meet protocol eligibility does not create appeal rights because DoD has no authority over eligibility for trials it did not sponsor or approve.
    • Services and supplies submitted for cost-sharing must independently meet the policy requirements.
    Denial Risk

    Excluded Trial or Service Types

    Do not submit excluded trial types or excluded treatment categories for coverage under this benefit. Exclusions include Phase 0 trials, observational or pathology-only studies, population-health studies, and treatments that would otherwise be excluded by statute or regulation.

    • Care rendered in the NIH Clinical Center or paid in full through an NIH grant program.
    • Studies that only examine infectious-disease pathology or population-health effects.
    • Treatments such as exercise programs or cosmetic procedures when otherwise excluded by statute or regulation.
    • Trials that do not meet the section's requirements, including industry-sponsored trials with no NIH Center or Institute listed as sponsor or collaborator.
    • Services or supplies provided free of charge under the investigational protocol.
    Denial Risk

    Non-Routine or Otherwise Non-Covered Care

    The benefit covers routine care associated with an eligible trial, but not non-treatment research activities or care that is not routine, medically necessary, or otherwise covered by TRICARE. Such amounts are not the beneficiary's responsibility when they are research costs excluded by the policy.

    • Excluded research costs include data collection, data management or analysis, research-nurse salaries, and investigational agents or methods used in the protocol.
    • Care paid in full by an NIH grant program or rendered in the NIH Clinical Center is excluded.
    • Treatments or services otherwise excluded by statute or regulation remain non-covered even if provided in a trial.

    Policy Context

    This policy permits TRICARE cost-sharing for routine medical care connected with eligible NIH-sponsored or NIH-approved interventional clinical trials addressing a Government-recognized infectious disease health emergency or its associated sequelae. Covered routine care may include trial-eligibility screening, examinations, imaging, laboratory monitoring, treatment of adverse effects, diagnostic services, rehabilitation, home health, inpatient or outpatient care, and necessary follow-up after active protocol treatment. The investigational treatment, investigational agents, and non-treatment research costs remain excluded unless otherwise covered under the policy.

    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.
    NIH involvementThe NIH Center or Institute may oversee the clinical trial in whole or in part.
    Trial relationshipThe NIH Center or Institute is responsible for initiating, funding, managing, or otherwise overseeing the clinical 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.
    ClinicalTrials.gov recognitionIdentification of the NIH Center or Institute as a collaborator on the specific clinical trial's ClinicalTrials.gov website constitutes NIH approval.
    Government-recognized infectious disease health emergency
    National declarationA national emergency declared by the President of the United States for a pandemic or epidemic resulting from an infectious disease.
    Public health declarationA Public Health Emergency declared by the Secretary of Health and Human Services for a pandemic or epidemic resulting from an infectious disease.
    Overseas recognitionFor care rendered overseas, the term also includes epidemics and pandemics recognized by foreign governments or the World Health Organization.
    Overseas trial limitationOnly NIH-sponsored or NIH-approved clinical trials in the region experiencing the recognized epidemic or pandemic are eligible for TRICARE coverage.
    Routine care
    DefinitionSupplies, services, and treatments that TRICARE otherwise would have covered during the normal course of treatment.
    Eligibility screeningRoutine care includes costs for screening tests to determine clinical trial eligibility.
    Monitoring servicesRoutine care includes examinations, imaging, and blood tests to monitor or assess patient health during the clinical trial.
    Medically necessary treatmentRoutine care includes drugs that TRICARE would cover in the absence of the clinical trial when necessary to treat treatment side effects, manage other aspects of the patient's medical treatment, or otherwise medically necessary.
    Frequency and magnitudeRoutine care may differ in frequency and magnitude from care provided in the absence of the investigational treatment when needed to monitor the investigational treatment.