The Department of Defense (DOD) finalized a rule in 2025 that materially changes how TRICARE — the health program covering active-duty service members, their families, military retirees, and other DOD-eligible beneficiaries — pays for the routine costs of participating in a clinical trial. For research administrators and coverage-analysis staff at sites that enroll TRICARE beneficiaries, the rule changes both who qualifies for coverage and which trials are covered, and it is legally separate from the Medicare framework most U.S. billing-compliance guidance is built around.
What TRICARE is, and why it matters for clinical trial billing
TRICARE is DOD’s regional managed-care health program, established under 10 U.S.C. Chapter 55 and implemented through 32 CFR Part 199 (the Civilian Health and Medical Program of the Uniformed Services, or CHAMPUS, regulations). It covers active-duty service members, activated National Guard/Reserve members, their eligible family members, and military retirees and their dependents. It is a distinct legal and administrative framework from the Department of Veterans Affairs (VA) healthcare system — TRICARE beneficiaries are not, by virtue of TRICARE eligibility alone, VA patients, and a coverage analysis written for VA-enrolled or Medicare-enrolled participants does not automatically apply to a TRICARE beneficiary.
When a TRICARE beneficiary enrolls in a clinical trial, the sponsor typically pays for the investigational intervention and trial-specific data collection, but someone still has to pay for the “routine costs” of care the participant would need regardless of the trial — office visits, standard imaging, routine labs, and management of the underlying condition. Whether TRICARE will pay those routine costs, and for which trials, is governed by 32 CFR 199 rather than by the Medicare statute, which is why a Medicare-focused NCD 310.1 coverage analysis cannot simply be reused for a TRICARE-covered participant.
Background: the pre-2025 coverage gap
Before the 2025 rulemaking, TRICARE’s clinical-trial coverage was narrow and temporary. DOD issued an interim final rule in October 2020 adding coverage for National Institute of Allergy and Infectious Diseases (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19, using the FDA’s expanded access (“compassionate use”) mechanism as part of the pandemic response. That provision was written as a temporary, COVID-specific fix — it did not create a general routine-cost benefit for TRICARE beneficiaries enrolled in NIH-sponsored trials outside that narrow scope, and research sites had limited, ad hoc grounds for billing TRICARE as the payer of routine costs for most other federally sponsored trials.
The 2025 final rule: what actually changed
On July 28, 2025, the Assistant Secretary of Defense for Health Affairs published a final rule titled TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments (90 FR 35422, Docket ID DOD-2020-HA-0050), effective August 27, 2025. It amends 32 CFR Part 199 in two connected ways:
- It creates a durable, generalized clinical-trial routine-cost benefit. TRICARE now covers services and supplies furnished in connection with Phase I, II, III, and IV clinical trials that are NIH-sponsored or NIH-approved, where the trial involves a new treatment or cure for a specific condition, or treatment of a currently uncontrolled symptom or aspect of that condition, and the condition itself is severely debilitating, life-threatening, or a rare disease. This replaces the earlier NIAID/COVID-19-only provision with a benefit that applies across NIH-sponsored research generally, not just infectious-disease trials.
- It terminates the temporary COVID-19 expanded-access provision. The rule removes the 2020 emergency-era text authorizing coverage of investigational drugs obtained through FDA expanded access programs specifically for COVID-19, since that temporary authority is superseded by the broader, permanent clinical-trial benefit and the COVID-19 public health emergency has ended.
Consistent with the general “routine costs” concept used across federal payer clinical-trial policy, DOD is covering care beneficiaries could not otherwise receive absent the trial and that may reasonably improve their symptoms or prognosis — not the experimental intervention itself, and not costs the trial sponsor is responsible for funding. Phase 0 (exploratory IND) studies, which are not designed to offer therapeutic benefit, are explicitly excluded from the benefit.
Eligibility criteria at a glance
| Element | What the final rule requires |
|---|---|
| Trial phase | Phase I, II, III, or IV. Phase 0 (exploratory IND) is not eligible. |
| Sponsorship | NIH-sponsored or NIH-approved (an NIH Center or Institute is involved in sponsoring or approving the trial). |
| Therapeutic aim | A new treatment or cure for a specific condition, or treatment of a currently uncontrolled symptom or aspect of that condition. |
| Condition severity | The underlying condition must be severely debilitating, life-threatening, or a rare disease. |
| What’s covered | Routine costs the beneficiary would otherwise need regardless of trial enrollment — not the investigational article or trial-specific research procedures. |
DOD has also described an interagency arrangement with NIH intended to support administration of these routine-cost payments across NIH-sponsored trials generally, rather than limiting the benefit to any single NIH institute. Sites should treat institute-specific implementation guidance as still developing and confirm current procedure directly with the relevant TRICARE regional contractor or the trial’s NIH sponsor before finalizing a budget that assumes TRICARE as payer of routine costs.
How this differs from Medicare’s clinical-trial coverage policy
Research administrators who already run Medicare coverage analyses under NCD 310.1 should not assume the two frameworks are interchangeable. They share a similar underlying concept — routine costs versus sponsor-funded research costs — but they are governed by different statutes, different deeming criteria, and different agencies:
- Legal basis. Medicare’s routine-cost policy sits under the Social Security Act and CMS’s National Coverage Determination 310.1. TRICARE’s sits under 10 U.S.C. Chapter 55 and 32 CFR Part 199, administered by DOD’s Defense Health Agency.
- Qualifying-trial test. Medicare’s “qualifying clinical trial” test looks at therapeutic intent plus one of several deeming criteria (including NIH funding, but also VA, DOD, CDC, AHRQ, or CMS funding, or conduct under an FDA IND). TRICARE’s 2025 rule instead requires NIH sponsorship or approval specifically, plus a condition-severity test (severely debilitating, life-threatening, or rare disease) that Medicare’s policy does not use in the same way.
- Population. Medicare coverage analysis applies to Medicare-enrolled participants (generally 65+, or qualifying disability/ESRD status). TRICARE’s applies to the separate, generally younger and working-age military-connected population — a participant can be TRICARE-eligible and never Medicare-eligible, or eligible for both if they are also a Medicare-eligible retiree (TRICARE for Life coordinates with Medicare in that case).
Practically, this means a site’s billing compliance workflow needs a distinct decision branch for TRICARE-covered participants rather than routing them through the same NCD 310.1 checklist used for Medicare beneficiaries, and consent/financial-disclosure documents should describe TRICARE coverage on its own terms rather than by analogy to Medicare.
What research sites and CRAs should do next
- Flag TRICARE eligibility at screening. Coverage analysis should ask whether a prospective participant is TRICARE-eligible as a distinct question from Medicare/Medicaid status, not as a fallback category.
- Confirm the trial meets the four eligibility elements above (phase, NIH sponsorship/approval, therapeutic aim, condition severity) before representing TRICARE as a routine-cost payer in the budget or consent form.
- Don’t assume expanded-access/compassionate-use pathways are TRICARE-covered. The 2025 rule specifically terminated the COVID-19 expanded-access provision; expanded-access use outside a qualifying NIH-sponsored trial is not covered by this benefit.
- Coordinate with the TRICARE regional contractor (the managed-care support contractor for the beneficiary’s region) early, the same way a site would confirm coverage with a Medicare Administrative Contractor, since claims processing and any prior-authorization expectations sit with the contractor rather than DOD directly.
- Keep the analysis separate from, but cross-referenced with, your Medicare NCD 310.1 analysis when a trial enrolls both populations, so the budget and consent documents reflect the correct payer logic for each participant.
Frequently asked questions
Does TRICARE pay for the experimental drug or device itself?
No. Consistent with the routine-costs framework used across federal payer clinical-trial policy, TRICARE covers the standard care a beneficiary would need regardless of trial enrollment — not the investigational article, and not research-only procedures the trial sponsor is responsible for funding.
Are all clinical trials eligible, or only NIH-sponsored ones?
Under the 2025 final rule, the trial must be NIH-sponsored or NIH-approved. Trials sponsored solely by industry, a non-NIH federal agency, or an academic institution without NIH sponsorship or approval do not fall under this specific benefit as written.
Does the rule cover Phase 0 or first-in-human exploratory studies?
No. Phase 0 (exploratory IND) studies are explicitly excluded, since they are designed to characterize pharmacokinetics/pharmacodynamics rather than to offer a therapeutic benefit to the participant.
Is TRICARE clinical trial coverage the same as VA coverage for veterans?
No. TRICARE and the VA healthcare system are separate programs with separate eligibility rules and separate clinical-trial coverage policies. This rule applies to TRICARE beneficiaries under 32 CFR Part 199, not to veterans receiving care solely through VA facilities.
When did the rule take effect?
The final rule was published in the Federal Register on July 28, 2025 (90 FR 35422) and took effect August 27, 2025.
Sources
- Department of Defense, “TRICARE Coverage of Clinical Trials and Termination of Expanded Access Treatments,” Final Rule, 90 FR 35422 (July 28, 2025), Docket ID DOD-2020-HA-0050, effective August 27, 2025 — Federal Register.
- 32 CFR Part 199 (Civilian Health and Medical Program of the Uniformed Services), eCFR.
- CMS National Coverage Determination 310.1, “Routine Costs in Clinical Trials,” Medicare Coverage Database.
