Laboratory Developed Tests

What are laboratory developed tests?

• LDTs assess risk or help guide treatment of certain medical conditions or rare diseases.
• Clinical laboratories develop LDTs and offer them to the public. But they don’t sell them to other labs.
• TRICARE doesn’t usually cover LDTs until the Food and Drug Administration approves them.

What is the Laboratory Developed Tests Demonstration Project?

• It allows TRICARE to review tests not evaluated by the FDA for safety and effectiveness.
• It gives you access to laboratory developed tests not usually covered.
• The demonstration runs through July 18, 2028.

How does it work?

You must:

• Meet your test’s coverage guidelines. 
• Get pre-authorization from your regional contractor for all covered tests, except the cystic fibrosis screening.
• Get an accredited clinical lab to do your test.

You can’t appealThe action you take if you don’t agree with a decision made about your benefit. denials under the demonstration.

Note: If you’ve paid for any of the tests in the demonstration since Jan. 1, 2013, you may get retroactive reimbursement. Contact your TRICARE regional contractor for more information.

TRICARE now covers several preconception and prenatal carrier screening tests as part of the TRICARE Basic benefit, with a limit per beneficiary of one test per condition per lifetime. If you received prenatal or preconception carrier screening tests between Dec. 27, 2021, and July 19, 2023, contact your TRICARE regional contractor for instructions on how to submit a claim for reimbursement. You can also request that TRICARE reprocess a denied claim.

For more information on how to submit a claim for reimbursement, visit Medical Claims.

What tests are included in the demonstration?

Check with your provider or regional contractor to learn what tests are included in the demonstration. TRICARE may add other tests in the future.