5 New Genetic Diagnostic Tests to Be Covered by Tricare

The Defense Health Agency has extended a pilot program that covers many now-common laboratory genetic tests and added five more to improve diagnostics and care for patients with breast, blood and prostate cancer and suspicious-looking moles or skin lesions.

The Pentagon's health arm announced Thursday that it has extended its pilot program that covers more than 45 laboratory-developed tests, or LDTs, through July 18, 2028.

The program was introduced in 2013 as a way for the Defense Department to cover some tests that didn't fall under the Food and Drug Administration's regulatory process, including BRCA1 and BRCA2 tests for breast cancer risk, in-utero tests for cystic fibrosis, and genetic tests for rare diseases.

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According to an update Thursday to the Tricare Manual, the newly covered tests include the Biotheranostics Breast Cancer Index, which can help predict the risk of a patient's breast cancer returning, helping guide treatment options; the DermTech Pigmented Lesion Assay, which can help rule out melanoma; and the FoundationOne Heme test, a genetic profile that identifies cancers like leukemia, lymphoma and myeloma, as well as some pediatric cancers and sarcomas.

The update also includes two tests by MDxHealth for men who have previously had prostate cancer and have markers that may indicate that they still have it.

The regulation of laboratory-developed tests has been debated over the past decade, with the FDA, which is responsible for regulating their safety and effectiveness, design quality and manufacturing, swinging from a previous hands-off approach to firmer oversight.

Still, Tricare is restricted by law from paying for medications or medical devices not formally approved by the FDA, requiring the DoD to institute the pilot to ensure that patients had access to proven tests in a rapidly developing field of medicine.

The DoD announced the creation of the pilot in 2014, a year after Tricare stopped covering LDTs following changes made by the American Medical Association to testing procedure codes that prompted their placement on a government "no pay" list.

That move, which left laboratory companies with more than $10 million in outstanding bills, prompted patient advocates and lab industry groups to push for coverage.

Tricare patients who have received one of the new tests since Jan. 1, 2023, may be eligible for reimbursement. While the DoD announced coverage of the five new LDTs this week, approval was effective the first of the year. Beneficiaries will need to file a claim to receive payment.

Most tests that fall under the demonstration project must be pre-approved by Tricare before they can be covered, according to Tricare. They also must be offered and administered by authorized providers.

-- Patricia Kime can be reached at Patricia.Kime@Military.com. Follow her on Twitter or Threads @patriciakime

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