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Laboratory Developed Test Demonstration Project Extended

Tuesday, August 25, 2020

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, recently extended through July 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. Please refer to Health Net Federal Services, LLC’s (HNFS’) LDT Coverage Criteria Guide, as it specifies coverage requirements for each LDT. Providers must also complete an LDT Letter of Attestation (LOA), which should be attached to the prior authorization request submitted via CareRadius® (recommended). For cystic fibrosis testing, the LOA must be submitted with the claim. Providers requesting more than one LDT need only submit one LOA with multiple tests indicated on that form.

Laboratories performing LDTs should ensure the ordering provider has obtained prior authorization or completed an LDT LOA prior to performing the test. 

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 Laboratory Developed Tests page.