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ACLA: TRICARE Decision to Deny Coverage of Molecular Diagnostic Tests Compromises Standard of Care for Military Families

(Washington, D.C.) – In a statement to the House Armed Services Subcommittee on Military Personnel addressing a hearing on the Defense Health Agency (DHA), the American Clinical Laboratory Association (ACLA) today expressed strong opposition to TRICARE’s current policy of non-coverage for molecular diagnostic tests provided to TRICARE beneficiaries seeking care through the community provider network.

“There is no sound clinical or regulatory rationale for this decision,” states ACLA in its hearing comments. “The decision should be reversed and coverage restored so that TRICARE beneficiaries and their families have access to the same standard of care available to TRICARE beneficiaries at Military Treatment Facilities and to patients covered by hundreds of public and private insurance plans.” TRICARE, the health care program for military service members and their families and managed by the Defense Health Agency (DHA), ceased providing coverage for over 100 molecular diagnostic tests January 2013. Those tests were placed on the No Government Pay Procedure Code List (NGPPCL) without notice or explanation to beneficiaries and denied reimbursement. Paradoxically, TRICARE continues to cover the same tests when they are ordered from a Military Treatment Facility (MTF). Military families seeking care outside of the MTF setting are denied coverage for critical tests that represent the standard of care for diagnosing and treating Cystic Fibrosis, Fragile X syndrome, spinal muscular atrophy, and many common cancers. ACLA’s statement further notes:

“TRICARE has become an outlier with its persistent policy of non-coverage. TRICARE’s rationale for failing to cover these tests is that they are Laboratory Developed Tests (LDTs); that is, they are tests that are created in-house by the laboratories furnishing them in accordance with the requirements of the federal Clinical Laboratory Improvement Amendments (CLIA). Laboratories do not sell the LDTs themselves, but use them to perform tests whose results are then furnished to physicians. Many, if not most, molecular diagnostics today are performed as LDTs. Despite TRICARE’s history of covering these laboratory developed tests, and TRICARE’s ongoing coverage of many other LDTs, the Defense Health Agency has stated that this subset of LDTs can no longer be covered because, it argues, the tests are medical devices and have not been approved by the Food & Drug Administration (FDA). This position is a plain misinterpretation of TRICARE’s own regulations. Those regulations look to whether or not a medical device can be lawfully marketed without approval or clearance from the FDA when determining TRICARE coverage. If it cannot, then TRICARE will not cover it. However, no such restriction applies to LDTs. LDTs can, and are, legally marketed without FDA approval; and therefore, TRICARE has no basis to exclude LDTs from coverage. In fact, FDA has repeatedly stated that it is exercising enforcement discretion and not requiring pre-market approval of LDTs.”

ACLA also points out that “clinical laboratory tests guide more than 70% of medical decisions made by healthcare professionals. The information provided by clinical labs helps diagnose, treat and monitor patients as accurately and quickly as possible. Our member laboratories proudly provide clinical laboratory services to our men and women in the armed services and their families.”

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