TRICARE Evaluation of CMS’s Approved Laboratory Developed Tests Demonstration Project

This notice is to advise interested parties of a Military Health System (MHS) demonstration project entitled TRICARE Evaluation of CMS Approved Laboratory Developed Tests Demonstration Project. The demonstration project is intended to determine whether it is feasible for the Department of Defense (DoD) to review CMS approved laboratory developed tests (LDTs), not yet examined by the FDA, to determine if they meet TRICARE requirements for safety and effectiveness and allow those that do, to be covered as a benefit under the TRICARE Program. The LDTs for this demonstration would be limited to only those that significantly inform clinical decision making for surveillance, surgical interventions, chemotherapy, or radiation therapy for cancer. The demonstration project will provide a valuation of the potential improvement of the quality of healthcare services for TRICARE beneficiaries who would not otherwise had access to these tests. Interested LDT device manufacturers, or individual (single) laboratories developing their own proprietary tests that have a CMS National Coverage Determination (NCD) or Local Coverage Determination (LCD) who desire the DoD to consider their tests for coverage under the TRICARE Program, are encouraged to submit LDTs for consideration. This demonstration will be effective 30 days after publication in the Federal Register. This demonstration will remain in effect for three years.