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Some genetic testing covered again

link Tom Philpott

Military Update

The Defense Health Agency, relying on medical laboratory experts and existing authority to conduct medical “demonstrations,” will restore TRICARE coverage this month for up to 40 genetic tests used in patient care.

Many of these laboratory-developed tests — also called molecular pathology tests — are viewed as medically necessary. But TRICARE had stopped reimbursing for more than 100 such tests in January 2013, believing it lacked authority to pay for them when such tests are ordered by civilian physicians delivering care through TRICARE provider networks.

Military treatment facilities have continued to order and pay for such tests routinely, which created a startling disparity of coverage between military direct care and purchased care contracts. Senior DHA officials acknowledged the coverage gap last February and vowed to close it.

The first step to do so will occur Friday when “30 to 40” genetic tests, those “most commonly performed” across U.S. medicine, will become reimbursable again under TRICARE, as part of a three-year medical demonstration project, said Army Maj. Gen. Richard W. Thomas, chief medical officer and director of healthcare operations for DHA.

Among genetic tests to be restored to TRICARE coverage is one that determines if a woman who is pregnant, or desires to become pregnant, carries a genetic marker for cystic fibrosis. That marker would indicate increased risk that a newborn would have CF.

TRICARE stopped paying for this and many more laboratory-developed tests (LDTs) after the American Medical Association changed its procedural codes for such lab work and clarified that these tests are “medical devices.”

TRICARE, in turn, concluded that under current support contracts it cannot pay for medical devices if not certified as safe and effective by the Federal Drug Administration. Because the FDA doesn’t review or approve genetic tests, TRICARE officials decided they had to stop coverage.

Civilian physicians continued to order such tests but after December 2012 TRICARE quietly began denying payments. For a time, many impacted laboratories absorbed the costs. But for some of the more costly tests ordered, TRICARE patients began receiving unexpected bills.

In a phone interview, Thomas explained that DHA earlier this year formed its own panel of experts, the Joint Lab Working Group, and began conducting its own review of safety and effectiveness of genetic tests. It used forensic science and other criteria to screen LDTs. One factor was whether major health insurance companies covered the tests, Thomas said.

Restored TRICARE coverage for up to 40 LDTs will occur under what DHA calls its Non-FDA-Approved Laboratory Test Demonstration Project, described in the June 18 Federal Register. A full list of genetic testing to be approved for TRICARE hasn’t been released yet. But coverage will be retroactive to Jan. 1, 2013, Thomas explained, so laboratories and patients will be able to apply for reimbursements of newly cleared tests that they had paid for back to that date.

Tom Philpott can be contacted at Military Update, P.O. Box 231111, Centreville, Va. 20120-1111, or by e-mail at:

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