TRICARE's Laboratory Developed Tests Demonstration Project Extended; New Tests Added
Friday, August 4, 2023
TRICARE’s Laboratory Developed Tests Demonstration Project (Demonstration), which increases access to and coverage for laboratory developed tests (LDT), has been extended until July 18, 2028. Through the Demonstration, TRICARE reviews and covers LDTs – diagnostic tests designed and manufactured by a single laboratory – that meet TRICARE requirements for safety and effectiveness but have not yet received U.S. Food and Drug Administration (FDA) approval.
New LDTs Added
Five new LDTs were added to the Demonstration’s list of covered tests:
- Biotheranostics Breast Cancer Index®
- DermTech Pigmented Lesion Assay (PLA)
- FoundationOne® Heme
- MDxHealth Confirm MDx
- MDxHealth Select MDx
Coverage Requirements
To be covered under the Demonstration, LDTs must:
- Be listed in TRICARE Operations Manual (TOM), Chapter 18, Section 3.
- Be provided by a TRICARE-authorized and Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Additionally, beneficiaries must meet TRICARE coverage criteria for the specific LDT and have received appropriate genetic testing counseling. Our recently updated Laboratory Developed Test Coverage Criteria Guide and Laboratory Developed Tests page detail coverage guidelines.
Authorization Requirements
Pre-authorization is required for all LDTs, except cystic fibrosis testing. Be sure to include a completed LDT Letter of Attestation (LOA) with your request. This form is available at our Letters of Attestation page.
Our revised LDT LOA covers single gene and panel tests. You only need to complete one form if requesting multiple tests. Note: If the LDT is not included in the Demonstration, but is FDA-approved and meets specific criteria, we may authorize the service under the basic TRICARE benefit. Refer to our Laboratory Developed Tests page for more details.
Claims Requirements
Be sure to use the appropriate modifier if performing an LDT more than once.
Check that a pre-authorization is on file or you’ve included a completed LOA with a claim. Without these, the claim will deny.
Note: HNFS recommends laboratories check for an ordering provider’s pre-authorization and completed LOA before performing an LDT for a TRICARE beneficiary. Visit our Laboratory Developed Tests page for more information.
