Defense Dept. Extends Lab-Developed Test Demonstration for TRICARE

The Department of Defense announced June 20 that it approved a threeyear extension of the Defense Health Agency Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project. The extension permits TRICARE to continue to LDTs for safety and value and approve their use for beneficiaries.

TRICARE, the health care program for active duty and retired uniformed service members and their families, and is managed by the Defense Health Agency (DHA). However, not all care is provided in military treatment facilities and TRICARE requires that all covered tests have FDA approval. This requirement eliminates LDTs for care consideration for its 9.4 million beneficiaries, limiting application of technological advancements, particularly in the area of genomic medicine.

The Laboratory Joint Working Group, consisting of clinical and laboratory experts from across military services, prioritizes tests for review based on published evidence of medical effectiveness. The group forwards its recommendation to the director of the Defense Health Agency for final approval for use. So far, the Military Health System says 100 tests have been given the green light, including those for cancer risk, diagnosis and treatment; pharmacogenetic testing; and diagnosis of genetic syndromes and inherited cardiovascular conditions.

Even with approval for use by TRICARE beneficiaries, pre-authorization is required and providers must submit a letter of attestation, with the test name, CPT code, and indication that the beneficiary meets the coverage criteria requirements.

"During the next three years, the DHA will continue to evaluate the LDT examination and recommendation process to assess feasibility, resource requirements, and the cost-effectiveness of establishing an internal safety and efficacy review process to permit TRICARE cost-sharing for an ever-expanding pool of non-FDA approved LDTs," said Aaron Siegel, a spokesperson for the Department of Defense, in a statement. "The results of the evaluation will… support future regulatory revisions which will enhance the flexibility of the Military Health System in responding to emerging technologies."

Takeaway: The extension of the DHA's LDT demonstration project has the potential to further expand LDT test coverage among TRICARE beneficiaries.