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. The purpose of the LDT Demonstration Project 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 LDT tests not yet approved by the FDA to determine if they are safe and effective for use. These LDTs primarily involved molecular and genetic testing.
Laboratory developed tests not part of the TRICARE Demonstration Project but that are FDA approved and in which the results of the test will influence the medical management of the individual or pregnancy, are TRICARE basic benefits.
Prior authorization is required for most LDTs except cystic fibrosis. Providers must submit the LDT letter of attestation (LOA), indicating the test name, CPT® code and attestation that the beneficiary meets the coverage criteria requirements found on 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 test is listed in the TRICARE Operations Manual, Chapter 18 and it meets the requirements listed in the Coverage Criteria Guide, the test will be covered under the LDT Demonstration.
- If the LDT test 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.
Submit authorization requests online. Learn more on our How to Submit page.
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 prior authorization or provided a completed LOA prior to performing the test. Claims will be denied when there is no prior authorization on file or LOA provided with the claim.
Additional information on these tests can be found in the TRICARE Operations Manual, Chapter 18.
The following are a few commonly excluded LDTs:
- Corus® CAD by CardioDx – testing for the likelihood of coronary artery disease in chest pain patients
- ChemoFx® assay by Precision Therapeutics Inc. – for predicting a patient's response to chemotherapy drugs
- PathfinderTG® (Molecular Topographic Genotyping) by RedPath Integrated Pathology, Inc. – a DNA diagnostic test for cancer
Corus CAD and its respective marks are trademarks of CardioDx. ©2012 CardioDx, Inc. All rights reserved.
ChemoFx and its respective marks are trademarks of Precision Therapeutics, Inc. ©2009 Precision Therapeutics, Inc. All rights reserved.
PathfinderTG and its respective marks are trademarks of RedPath Integrated Pathology. 2012© RedPath Integrated Pathology. All rights reserved.