Laboratory Developed Tests

Laboratory developed tests:

  • Assess risk or help guide treatment of certain medical conditions or rare diseases
  • Are developed by clinical laboratories that offer tests to the public, but don't sell them to other labs
  • Aren’t usually covered by TRICARE until approved by the U.S. Food and Drug Administration (FDA)

The Laboratory Developed Tests Demonstration Project:

  • Allows TRICARE to review tests not evaluated by the FDA for safety and effectiveness
  • Gives you access to laboratory developed tests not usually covered
  • Includes coverage for prenatal and preconception cystic fibrosis carrier screening, with some limitations

How does it work?

  • You must meet your test’s coverage guidelines
  • You must get pre-authorization from your regional contractor for all covered tests, except the cystic fibrosis screening
  • Accredited clinical laboratories must do your tests
  • You can't appealThe action you take if you don’t agree with a decision made about your benefit. denials under the demonstration
  • If you’ve paid for any of the tests in the demonstration since January 1, 2013, you may get retroactive reimbursement
  • Save your receipts and check back here for details on retroactive reimbursement rules

What tests are included in the Demonstration?

Please check with your provider or regional contractor on what tests are included in the demonstration.  We may add additional tests in the future.

Last Updated 3/20/2022