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    v1.0.30
    OpenPayerPolicy UpdatesTransplantDHA Cancer Trial Coverage Policy Update | OpenPaye…
    Ask Trek AI about this page
    ModifiedDHAPolicy C7S24_3

    Coverage of Cancer Clinical Trials

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    Coverage of selected TRICARE-eligible patients participating in qualifying NCI-sponsored or NCI-approved interventional cancer clinical trials conducted on or after August 27, 2025.

    Policy Summary
    PayerDHA
    PolicyCoverage of Cancer Clinical Trials
    Policy CodePolicy C7S24_3
    Change TypeExpanded coverage
    Effective DateAug 27, 2025
    Next Review DateN/A
    Key ActionObtain preauthorization before the initial evaluation of a TRICARE-eligible beneficiary in an eligible cancer clinical trial.
    SourceLink
    POLICY UPDATE CHANGES

    Coverage was expanded for qualifying NCI-sponsored or NCI-approved cancer clinical trials under the Final Rule effective August 27, 2025.

    2Policy sections listed for cancer clinical-trial coverage
    5Clinical-trial sections listed under Chapter 7
    4Eligible trial phases
    5Core conditions for treatment coverage
    7Explicit exclusion categories
    CPCancer trial claim processing code

    Cancer Clinical Trial Coverage Criteria

    Eligible trial and treatment coverage

    Covered when all of the following are met:

    Eligible cancer clinical trial participation

    • Trial and patient requirements

      • The patient is a TRICARE-eligible beneficiary selected to participate in an NCI-sponsored or NCI-approved clinical trial studying cancer prevention, screening, early detection, or treatment.Phase I-IV
      • The provider has obtained preauthorization for the proposed treatment before the patient's initial evaluation.
      • The protocol is an NCI-sponsored or NCI-approved Phase I, Phase II, Phase III, or Phase IV protocol.Phase I-IV
    Policy Summary
    PayerDHA
    PolicyCoverage of Cancer Clinical Trials
    Policy CodePolicy C7S24_3
    Change TypeExpanded coverage
    Effective DateAug 27, 2025
    Next Review DateN/A
    Key ActionObtain preauthorization before the initial evaluation of a TRICARE-eligible beneficiary in an eligible cancer clinical trial.
    SourceLink
    On This Page
    Cancer Clinical Trial Coverage CriteriaClaims Processing CodeAuthorization, Documentation, and Denial RisksPolicy Scope and ContextKey Clinical Trial 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.

  1. The clinical trial is interventional rather than observational and studies a specific treatment for a specific cancer or complication of cancer.
  2. The patient continues to meet the entry criteria for the protocol.
  3. The institutional and individual providers are TRICARE-authorized providers.

    4. Associated medical care and supplies

    Covered associated services include:

    Covered services and supplies

    • Medical care and testing required to determine eligibility for an NCI-sponsored or NCI-approved clinical trial, including eligibility evaluation at the institution conducting the trial.
    • Medical care required as a result of participation in an NCI-sponsored or NCI-approved clinical trial.
    • The purchase and administration of approved chemotherapy agents, except sponsor-funded investigational agents.
    • Inpatient and outpatient care, including diagnostic and laboratory services, when those services are not otherwise reimbursed under an NCI grant program or provided in the NIH Clinical Center.

    Excluded trials and costs

    Not covered when any of the following applies:

    Excluded trial or service

    • The study is observational, studies only the pathology of a specific cancer, or studies only the impact of cancer on population health.
    • The study is a Phase 0 clinical trial.
    • The care is rendered in the NIH Clinical Center or paid in full through an NIH grant program.
    • The clinical trial studies a treatment that, even if proven effective, would otherwise be excluded by statute or regulation, such as exercise programs or cosmetic procedures.
    • The cost is associated with non-treatment research activities or with services or supplies that are not part of routine care provided in conjunction with the clinical trial, including data collection, data management or analysis, research nurse salaries, investigational agents, or investigational methods.
    • The service or supply is provided free of charge under the investigational protocol.
    • The trial does not meet the policy requirements, including industry-sponsored trials that are neither NCI-sponsored nor NCI-approved.

    Excluded studies include observational studies, studies limited to the pathology of a specific cancer, and studies limited to the impact of cancer on population health.

    Phase 0 clinical trials are excluded from coverage.

    Care rendered in the NIH Clinical Center, or care paid in full through an NIH grant program, is excluded from coverage.

    Clinical trials studying treatments that would otherwise be excluded by statute or regulation are not covered, even if the treatment is proven effective. Examples include exercise programs and cosmetic procedures.

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

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

    Trials that do not meet the policy requirements are excluded, including industry-sponsored trials that are neither NCI-sponsored nor NCI-approved.

    Claims Processing Code

    Cancer clinical trial claim processingModifier
    CPSpecial processing code used to designate the claim is associated with a cancer clinical trial

    Authorization, Documentation, and Denial Risks

    Prior Authorization

    Preauthorization Before Initial Evaluation

    Obtain preauthorization for the proposed treatment before the beneficiary’s initial evaluation at the institution conducting the NCI-sponsored or approved clinical trial. Retroactive authorization may be available only under the applicable TRICARE provisions.

    Documentation Required

    Required Preauthorization Documentation

    Submit preauthorization with complete patient, sponsor, protocol, eligibility, and notification information so the contractor can verify the request.

    • Patient’s name and the last four digits of the sponsor’s Social Security number (SSN).
    • Certification that the protocol is NCI-sponsored or NCI-approved, including the protocol title, NCI protocol number, ClinicalTrials.gov ID, and/or other appropriate evidence of sponsorship or approval.
    • Certification that the patient meets all entry criteria for the protocol.
    • Certification that the contractor will be notified if the patient becomes ineligible for the study before treatment.
    Documentation Required

    Evidence of NCI Sponsorship or Approval

    Document NCI sponsorship or approval using an accepted source. NCI sponsorship may be established through CTEP, Cooperative Group Studies, NCI Grants or Cancer Center Studies, or qualifying protocols co-sponsored by NCI and another federal agency.

    • Identification in the NCI comprehensive cancer database, Physician’s Data Query (PDQ), or NCI supplements to that database.
    • Formal approval notification from the Clinical Protocol Review and Monitoring Committee.
    • Verification from the NCI project officer.
    • A trial-specific ClinicalTrials.gov page identifying NCI sponsorship or listing NCI as a collaborator for an NCI-approved study.
    • For overseas trials, verification of NCI sponsorship or approval by the NCI project officer.
    • If sponsorship or approval is unclear or the study is not listed in PDQ, work with NCI staff to verify it.
    Denial Risk

    Failure to Meet Eligibility or Authorization Requirements

    Coverage and authorization may be denied when the request does not satisfy the trial, authorization, or provider requirements. The beneficiary must continue to meet the protocol’s entry criteria, and the trial must qualify under the cancer clinical-trial benefit.

    • Preauthorization was not obtained before the initial evaluation, subject to applicable retroactive-authorization rules.
    • The trial is not an NCI-sponsored or NCI-approved Phase I, II, III, or IV protocol, or is not an eligible phase of a multi-phase trial.
    • The trial is observational rather than interventional, or does not study a specific treatment for a specific cancer or cancer complication.
    • The patient does not meet or no longer meets the protocol’s entry criteria; notify the contractor before treatment if the patient becomes ineligible.
    • The institutional and individual providers are not TRICARE-authorized providers.
    • The study is not otherwise shown to satisfy the requirements of the cancer clinical-trial benefit.
    Denial Risk

    Excluded Trials, Services, and Research Costs

    Do not bill TRICARE for excluded trials, services, or research costs. Excluded research costs are not the responsibility of beneficiaries participating in the clinical trial.

    • Observational studies, studies limited to cancer pathology, and studies limited to the population-health impact of cancer.
    • Phase 0 clinical trials.
    • Care rendered in the NIH Clinical Center or paid in full through an NIH grant program.
    • Trials studying treatments that would remain excluded by statute or regulation, such as exercise programs or cosmetic procedures.
    • Non-treatment research activities and services or supplies outside routine care, including data collection, data management or analysis, research-nurse salaries, and investigational agents or investigational methods used in the protocol.
    • Services or supplies provided free of charge under the investigational protocol.
    • Trials that do not meet the policy requirements, including industry-sponsored trials that are neither NCI-sponsored nor NCI-approved.
    Note

    Protocol Eligibility Outside DoD Authority

    The Department of Defense has no authority over protocol eligibility for clinical trials that are not sponsored or approved by the DoD. If a patient does not meet the eligibility criteria for enrollment in a specific non-DoD-sponsored or non-DoD-approved trial, appeal rights do not apply.

    Policy Scope and Context

    This policy addresses coverage for selected TRICARE-eligible beneficiaries participating in qualifying cancer clinical trials conducted on or after August 27, 2025. Eligible trials are NCI-sponsored or NCI-approved, interventional studies evaluating a specific treatment for a specific cancer or cancer complication, including cancer prevention, screening, early detection, or treatment. Coverage is subject to the policy’s trial eligibility, patient eligibility, provider authorization, and exclusion requirements.

    Key Clinical Trial Terms

    NCI-approved study
    DefinitionA clinical research study involving human participants and studying a specific intervention in which the NCI collaborates with the study sponsor.
    NCI supportNCI support may include funding, clinical-trial design, implementation, data analysis, or reporting.
    Identifying evidenceNCI approval may be confirmed on the trial-specific ClinicalTrials.gov page when NCI is listed as a collaborator.
    NCI-sponsored clinical trial
    DefinitionA clinical trial sponsored by the National Cancer Institute through recognized NCI programs, groups, grants, cancer centers, federal-agency partnerships, or other NCI-recognized evidence.
    NCI pathwaysSponsorship may occur through the Cancer Therapy Evaluation Program (CTEP), Cooperative Group Studies, NCI Grants, or Cancer Center Studies.
    Additional pathwaysNCI sponsorship may also be established through co-sponsorship with other federal agencies or identification on the trial-specific ClinicalTrials.gov page.
    DocumentationEvidence may include listing in the NCI Physician's Data Query database or NCI supplements, formal Clinical Protocol Review and Monitoring Committee approval, or verification from the NCI project officer.
    Interventional cancer clinical trial
    DefinitionA trial that studies a specific treatment for a specific cancer or complication of cancer.
    Treatment focusThe trial evaluates an intervention intended to treat the cancer or a complication of cancer, rather than merely observing disease.
    Not qualifying by itselfStudies limited to observing disease, studying cancer pathology, or evaluating population-health effects are not interventional cancer clinical trials for this definition.