Originally published June 10.
NEW YORK (GenomeWeb) -- The non-profit health advocacy organization Genetic Alliance is asking its members to sign a letter to legislators, asking them to take action so that military health benefits provider, Tricare, cannot deny coverage of lab-developed tests not approved or cleared by the FDA.
Tricare is the healthcare program of the US Defense Health Agency and provides benefits to military personnel, their families, and retirees. In January 2013, Tricare issued a policy ceasing coverage of more than 100 lab-developed tests. Many of these tests diagnose genetic diseases such as Fragile X syndrome, cystic fibrosis, and spinal muscular atrophy. While certain LDTs may still be covered for those who use a Military Treatment Facilities, LDTs mostly are not covered for those who use a civilian healthcare provider.
"Tricare's lack of coverage of these vital healthcare services places [it] out of step with other government programs and commercial health insurance," Genetic Alliance states in the letter it wants its members to sign and send to congress. Ultimately, the organization wants members of Congress to rectify this "unequal treatment of Tricare beneficiaries" in the National Defense Authorization Act for FY2015.
Tricare stopped paying for many LDTs last year after the American Medical Association instated new CPT codes for molecular tests that enabled private and government payors to better identify which tests they were paying for. Under Tricare's policies it cannot pay for tests or medicines that aren't approved by the US Food and Drug Administration.
However, as Genetic Alliance points out, the FDA has long had a policy of "enforcement discretion" over LDTs, and has left regulatory oversight of the majority of lab tests in the hands of the Centers for Medicare & Medicaid Services. The FDA has said it intends to issue guidelines regulating LDTs based on their risk to patients' health. However, absent such guidelines, a two-path regulatory framework continues to exist for LDTs.
"There are thousands of LDTs currently legally marketed, which neither have, nor are required to have FDA clearance or approval," Genetic Alliance points out in its letter. "Despite acknowledging the important role of LDTs in healthcare delivery, the Defense Health Agency has denied coverage of these tests for over a year.
The group further noted that despite Tricare's non-coverage policy for LDTs, some labs have continued to provide tests to Tricare patients and are awaiting payment. Other labs, meanwhile, have had to absorb the cost of performed tests or have sought help from patient advocacy organization. According to a March article in the Military Times the cost of non-covered tests are passed on to beneficiaries.
"We urge you to direct [the Defense Health Agency] to restore coverage for these laboratory developed tests," Genetic Alliance states in its letter to legislators. The organization is asking members to sign the letter by June 15.
The American Clinical Laboratory Association has also been urging members of Congress to address Tricare's policy toward LDTs. The lab group has estimated that diagnostics providers have performed up to $10 million worth of free testing for Tricare patients.
Tricare, on its website, acknowledges that for the most part it doesn't cover LDTs, except for a few tests included in a demonstration project, such as Myriad Genetics' BRACAnalysis test for gauging hereditary risk of breast and ovarian cancer, and Genomic Health's Oncotype DX breast cancer recurrence test. DHA officials have recently discussed expanding the demonstration project to review the clinical utility of other LDTs.