LDTs: TRICARE Beneficiaries Get At Least 3 More Years of Access

Some of the labs that participate in TRICARE got some good news when the Department of Defense announced that it has extended the so called Approved Laboratory Developed Tests (LDTs) Demonstration Project for three more years.

TRICARE & LDTs

TRICARE, the federal health care program for members of the military and their families, normally covers only tests that the FDA has approved as safe and effective. That policy effectively bars LDTs which, despite offering great promise, are still not proven enough to meet the FDA’s stringent approval requirements.

But in June 2014, TRICARE launched a pilot project designed to provide the program’s 9.4 million beneficiaries limited access to LDTs. The Defense Health Agency (DHA) Evaluation of Non-United States Food and Drug Administration pilot was slated to last three years and expire this June. But on June 20, 2017, the DHA announced that it has extended the pilot through 2020.

How the Pilot Works

Under the pilot, a panel of clinical and lab experts from the different military services known as the Laboratory Joint Working Group prioritizes tests for review based on published evidence of medical effectiveness. The Group forwards its recommendations to the DHA director for final approval for TRICARE use. According to the Military Health System, 100 LDTs have so far received the green light, including tests for cancer risk, diagnosis and treatment; pharmacogenetic testing; and diagnosis of genetic syndromes and inherited cardiovascular conditions.

LDTs approved for use by TRICARE are still subject to limitations. Beneficiaries must get pre-authorization and providers must submit a letter of attestation listing the test name, CPT code and indication that the beneficiary meets the coverage criteria requirements.

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