A Statement from ACLA on the Defense Health Agency’s Announcement of a Demonstration Project to Evaluate LDTs for TRICARE Coverage

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA), in response to the publication in the Federal Register today of a demonstration project by the Defense Health Agency (DHA) to evaluate laboratory developed tests (LDTs) for coverage by the TRICARE program, said it greatly appreciates DHA’s effort to further review certain laboratory tests, but reiterated its view that current regulations already allow for TRICARE coverage of LDTs.

In fact, TRICARE, like Medicare, Medicaid and commercial insurers, has a long history of covering LDTs, which play a critical role in the diagnosis and treatment of disease.  “While ACLA maintains current regulations allow for TRICARE coverage of laboratory developed tests, if a demonstration project facilitates the restoration of coverage for molecular pathology tests for all TRICARE beneficiaries, then it is important to move forward in this process,” said Alan Mertz, president of the ACLA. “ACLA commends the DHA for this step forward to restore coverage to molecular pathology testing services for all TRICARE beneficiaries. Further, we offer the expertise of our clinical laboratory members to provide relevant clinical data and research on molecular pathology tests as our labs routinely do with other payers.”

In January 2013, without notice to beneficiaries or healthcare providers, TRICARE stopped reimbursing clinical laboratories for more than 100 molecular pathology tests when care was obtained from the civilian provider network.  Testing services for TRICARE beneficiaries accessing healthcare at a military treatment facility were not affected.  Examples of the affected services include tests for Cystic Fibrosis, Fragile X syndrome, and other tests considered standard of care in the diagnosis and treatment of leukemia, lung and other cancers.  Committed to patient care, many labs have continued to provide these critical services to TRICARE beneficiaries, and are still seeking reimbursement.

TRICARE’s abrupt change in coverage led to an outpouring of concern from members of Congress, military organizations, medical societies, patient and disease groups and laboratories, all of whom have urged the DHA to restore TRICARE coverage for these critical tests.  In addition to the demonstration project, S. 2410, the Carl Levin National Defense Authorization Act for FY 2015, includes a provision to clarify DHA’s authority to cover LDTs.  ACLA has endorsed that provision, Section 705, Authority for Provisional TRICARE Coverage for Emerging Health Care Products and Services, and believes its enactment remains necessary despite announcement of the demonstration project by DHA.

“ACLA’s members are committed to working with the DHA and Congress to see that all TRICARE beneficiaries have access to groundbreaking diagnostic innovations,” concluded Mertz.

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