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LDT Demonstration Project Extended; New LDT-Specific Letters of Attestation Available

Friday, May 14, 2021

Laboratory developed tests (LDTs) are diagnostic tests designed, manufactured and used by a single laboratory. For an LDT to be considered for coverage under TRICARE, it must meet specific requirements. In an effort to improve the quality of health services for beneficiaries, TRICARE offers limited coverage for certain non-FDA approved LDTs through its LDT Demonstration Project. The LDT Demonstration Project, extended through July 18, 2023, allows TRICARE to review certain Centers for Medicare and Medicaid Services-approved LDTs that have not yet been approved by the FDA to determine safety and effectiveness.

Coverage requirements

The following requirements must be met in order for an LDT to be covered under TRICARE: 

  • The LDT must be listed in the TRICARE Operations Manual (TOM), Chapter 18, Section 3,
  • the laboratory must be a TRICARE-authorized and Clinical Laboratory Improvement Amendments (CLIA)-certified provider, and 
  • the beneficiary must meet TRICARE coverage criteria for the specific LDT and have received appropriate genetic testing counseling.

Prior authorization

Prior authorization is required for all LDTs, except cystic fibrosis testing. Providers must also complete an LDT Letter of Attestation (LOA), which should be attached to the prior authorization request. We now offer two LDT LOAs: one for single-gene LDTs and one for panel LDTs. Each has expanded coverage criteria to help you provide us with the details required. For cystic fibrosis testing, the LOA must be submitted with the claim. Find these on our Letters of Attestion page.

In addition to the new LOAs, you can review coverage criteria for each LDT in our LDT Coverage Criteria Guide.

Laboratories performing LDTs should make sure the ordering provider has obtained prior authorization or completed the appropriate LOA prior to performing any tests. 

HNFS authorizes LDTs in accordance with the TOM, Chapter 18, Section 3. Providers who perform LDT procedures more than once should use the appropriate modifiers and the claim will be processed accordingly. Claims submitted without prior authorization and/or a completed LOA will be denied.

For complete benefit details, visit our Benefits A–Z page.