DHA operations chief vows some relief from lab fees for Genetic Tests

The newly assigned chief medical officer and director of healthcare operations for the new Defense Health Agency (DHA), acknowledges that some Tricare patients and their civilian physicians face lab fee challenges that the DHA needs to address. A year ago Tricare quietly stopped reimbursing civilian laboratories for more than 100 genetic or laboratory-developed tests (LDTs). With hundreds of genetic tests developed every year, Defense health officials decided to use an existing regulation to tighten coverage and force labs to have tests screened for safety and effectiveness through the Food and Drug Administration (FDA). Absent FDA approval, Tricare can’t pay for these tests. The DHA is gathering information on each LDT not covered by Tricare including frequency of use, how much Tricare previously paid for it and military physicians who order it. For those tests, DHA will seek expedited review by FDA. The American Clinical Laboratory Association (ACLA), which lobbies on behalf of laboratories being impacted by tightened Tricare coverage, has opposed subjecting genetic testing to new hurdles of review. The FDA does not require LDTs to go through FDA approval.  So why would laboratories submit their LDTs for approval to an agency that does not require them to do so.