The Defense Health Agency, Falls Church, Va, has added 32 tests to its demonstration project, ‘Evaluation of Non-US FDA Approved Laboratory-Developed Tests.’ The demonstration project, which covered 41 tests before the new additions, allows the Tricare healthcare program to review tests not examined by FDA to determine whether they are safe and effective for use.
Many recently approved laboratory-developed tests (LDTs) assist providers with cancer diagnosis, cancer risk, and cancer treatment. Others test for blood or clotting disorders, genetic diseases or syndromes, or neurological conditions.
Generally, Tricare only covers LDTs that have been reviewed and approved by FDA. The demonstration project allows the US Department of Defense to perform its own evaluation of an LDT, establish a list of such tests deemed safe and effective, and establish a process to add new tests to that list.
Tricare maintains and publishes a list of approved tests, and continually updates it as new tests are reviewed and approved for coverage. Beneficiaries must receive prior authorization from their regional contractor for an approved LDT to be covered, except for preconception and prenatal cystic fibrosis carrier screening.
Since September 2014, more than $36 million in claims have been paid under the demonstration project.
For more information, visit Tricare.