Department of Defense June 18, 2014 – Federal Register Recent Federal Regulation Documents

This notice is to advise interested parties of a Military Health System (MHS) demonstration project under the authority of Title 10, United States Code, Section 1092, entitled Defense Health Agency (DHA) Evaluation of Non-United States Food and Drug Administration (FDA) Approved Laboratory Developed Tests (LDTs) Demonstration Project. The demonstration project is intended to further evaluate whether it is feasible for the Department of Defense (DoD) to review LDTs not yet examined by the FDA to determine if they meet TRICARE's requirements for safety and effectiveness according to the hierarchy of reliable evidence (32 CFR 199.4(g)(15)(i)(C) and 32 CFR 199.2(b)), or TRICARE's rare disease policy (32 CFR 199.4(g)(15)(ii)) in the case of LDTs used in the diagnosis or medical management of a rare disease (32 CFR 199.2(b)), and allow those that do to be covered as a benefit under the TRICARE Program. The demonstration project will evaluate feasible alternatives to support modifications to 32 CFR 199.4(g)(15)(i)(A) to allow coverage for non-FDA approved LDTs that otherwise meet the TRICARE requirements for safety and effectiveness. The Department currently has an ongoing demonstration project to test this same provision for LDTs with a Center for Medicare and Medicaid Services (CMS) national or local coverage determination that were submitted by laboratories for consideration for coverage under TRICARE. However, this new demonstration is being conducted in order to be able to evaluate the feasibility of establishing a cost-effective and efficient way to review an expanded pool of non-FDA approved LDTs prioritized based on their potential high utilization and clinical utility within the TRICARE population. This new demonstration project will also extend coverage for prenatal and preconception cystic fibrosis carrier screening, when provided in accordance with the American College of Obstetricians and Gynecologists guidelines in order to allow DoD to establish whether there is a benefit to offering such testing to TRICARE beneficiaries.