Laboratory Developed Tests

A laboratory developed test (LDT) is a diagnostic test that is designed, manufactured and used within a single laboratory. In order for an LDT to be considered for coverage the following must be met:

• Laboratory must be a TRICARE-authorized and Clinical Laboratory Improvement Amendments (CLIA)-certified provider,
• Test is listed on our Laboratory Developed Test Coverage Criteria Guide,
• Beneficiary must have received counseling regarding the requested genetic test, and
• Beneficiary meets the coverage criteria for the requested test.

Note: Some LDTs are not yet approved by the United States Food and Drug Administration (FDA), but are covered under the LDT Demonstration Project (Demonstration). The purpose of the Demonstration is to improve the quality of health services for TRICARE beneficiaries. The Demonstration allows TRICARE the opportunity to review a limited list of Centers for Medicare and Medicaid Services (CMS)-approved LDTs not yet approved by the FDA to determine if they are safe and effective for use. These LDTs primarily involve molecular and genetic testing.

LDTs that are not part of the Demonstrationt but are FDA approved and for which the results of the test will influence the medical management of the individual or pregnancy, will be covered under the TRICARE basic benefit. Also refer to Genetic Counseling and Testing.

Authorization

Pre-authorization is required for most LDTs except cystic fibrosis* and noninvasive prenatal screening for trisomies 13, 18, 21, X, and Y. Providers must submit the LDT letter of attestation (LOA), indicating the test name, Current Procedural Terminology (CPT®) code and attestation that the beneficiary meets the coverage criteria requirements found in our Laboratory Developed Test Coverage Criteria Guide. If the provider is requesting more than one LDT, he/she can submit one LOA with multiple tests on that form.

• If the LDT is listed in TRICARE Operations Manual, Chapter 18 and it meets the requirements listed in the Laboratory Developed Test Coverage Criteria Guide, the test will be covered under the Demonstration.
• If the LDT is not included in the Demonstration, but is FDA approved as noted per the FDA DeNovo 510K, Premarket Approvals (PMA), and/or Product Classification databases, and the results will influence the medical management of the beneficiary, the test will be covered under the basic benefit.

*TRICARE covers preconception and prenatal carrier screening under the TRICARE basic benefit for the following conditions: cystic fibrosis, spinal muscular atrophy, fragile X syndrome, Tay-Sachs disease, hemoglobinopathies, and conditions linked with Ashkenazi Jewish descent. Refer to Genetic Counseling and Testing.
 

Authorization Submissions

Submit pre-authorization requests online. Learn more on our How to Submit page. 

Claims

Providers who perform LDT procedures more than once should use appropriate modifiers and the claim will be processed accordingly. Laboratories performing these tests should ensure the ordering provider has obtained a pre-authorization or provided a completed LOA prior to performing the test. Claims will be denied when there is no pre-authorization on file or LOA provided with the claim.

Additional Information

Additional information on these tests can be found in the TRICARE Operations Manual, Chapter 18.