Earlier this year, TRICARE, a health care program of the U.S. Department of Defense Military Health System, stopped funding certain diagnostic genetic tests, deeming them medically unnecessary, according to the Albuquerque Journal. That forced servicemembers to pay out of pocket for particular tests ordered by civilian doctors. For example, servicemembers receiving BRCA1 and BRCA2 tests for breast cancer and in-utero cystic fibrosis were not covered by the military health organization, according to Military Times.
Fortunately, Military Times reported servicemembers will regain coverage for 35 diagnostic genetic tests starting Sept. 1. Additionally, those servicemembers that had to pay out of pocket for genetic tests since Jan. 1 may be able to receive retroactive reimbursement, according to the TRICARE website. It is all part of a three-year program aimed at offering military members the safest and most effective methods of treatment and preventative care.
Fixing the previous conflict
TRICARE was forced to discontinue funding for diagnostic genetic tests because the procedures are largely not regulated by the U.S. Food and Drug Administration, Military Times reported. By law, TRICARE is barred from providing funding for medications and equipment not approved by the FDA. Previously, the FDA did not attempt to approve the laboratory-developed tests because they were considered inexpensive, easy to administer and procedures did not leave patients at risk. However, advancements in technology have changed the nature of LDTs, and some of the tests compete with similar FDA-approved procedures.
The new program
Currently, particular guidelines for the new program are still in development, according to TRICARE. However, there is a specific method of obtaining approval for TRICARE funds outlined by the organization. LDT-seeking servicemembers must first meet a test's coverage guidelines, receive prior authorization from a registered contractor and receive care from an accredited clinical laboratory. The organization noted that prenatal and preconception cystic fibrosis carrier screenings come with fewer limitations.
The change is meant to provide patients with more reliable test results over time as the FDA seeks to increase oversight of LDTs and establish a set of regulatory guidelines, Military Times reported.
"Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority," FDA commissioner Margaret Hamburg, M.D., told Military Times. "Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether."