Notice of Five-Year Extension of Defense Health Agency Evaluation of Non-United States Food and Drug Administration Approved Laboratory Developed Tests Demonstration Project

Issuing agencies

Abstract

This notice is to advise interested parties of an additional five-year extension of the Defense Health Agency's (DHA) Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project (hereinafter referred to as the "LDT demonstration"). The original notice was published on June 18, 2014. The LDT demonstration was effective July 18, 2014. It remained in effect for three years (July 18, 2017). A notice was published on June 20, 2017 extending the LDT demonstration for three years. The three-year extension was effective July 19, 2017, through July 18, 2020. A second notice extending the LDT demonstration for an additional three years was published on July 10, 2020. The three-year extension was effective July 19, 2020. It is scheduled to end July 18, 2023. As uncertainty remains regarding future regulatory oversight of LDTs, the LDT demonstration will now be extended for five additional years (July 18, 2028). Additionally, this notice announces the removal of preconception and prenatal carrier screening for Cystic Fibrosis (CF) from the LDT demonstration as these carrier screening tests have been added to the TRICARE Basic (i.e., medical) benefit as directed by the National Defense Authorization Act (NDAA) of 2022.