The Defense Health Agency has announced which genetic tests Tricare will cover starting in September.
The Pentagon’s health arm published a list Friday of 35 laboratory-developed tests covered under a new pilot program, from the better-known BRCA1 and BRCA2 tests for breast cancer and in-utero cystic fibrosis to tests for rare inherited disorders like Lynch syndrome and Von Hippel-Lindau disease.
The demonstration project starts Sept. 1. But if beneficiaries paid for a test on the list since Jan. 1, 2013, they may be eligible for reimbursement. They will have to file a claim to receive payment, according to a Tricare news release.
DHA created the pilot project as a way to cover the tests, which, until recently, have not been regulated by the Food and Drug Administration. By law, Tricare is restricted from paying for medications or equipment not approved by the FDA — even those not subject to FDA approval. Tricare drafted the pilot as a way to cover the tests while the FDA debated how to proceed on regulating laboratory-developed tests.
The FDA had taken a hands-off approach to LDTs because they once were considered simple and posed little risk to patients. But as technology has advanced, so have LDTs; some are now costly and controversial, and compete directly with similar tests that require FDA-approval.
But the agency announced July 31 it would strengthen oversight of many laboratory developed tests, phasing in regulatory requirements over the next decade and concentrating on those tests that could produce results that pose a risk to patients.
“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority,” FDA Commissioner Dr. Margaret Hamburg said. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether.”
Tricare stopped covering many LDTs in January 2013 because changes made by the American Medical Association to its testing procedure codes led Tricare to place the tests on the government’s “no pay” list, according to Tricare officials.
That move left laboratory companies with more than $10 million in outstanding bills, and lab industry groups, which had insisted that Tricare had the legal authority to pay for the tests, pressed for coverage.
DHA health care operations director Army Maj. Gen. Richard Thomas said in July that DoD now is reimbursing the companies for tests that fall under the demonstration project.
Most tests under the Defense Health Agency Evaluation of Non-U.S. FDA-Approved Laboratory Developed Tests Demonstration Project must be pre-approved by Tricare before they can be covered, according to Tricare.
They also must be offered by an authorized provider.
For more information, see the health.mil website.