TRICARE beneficiaries soon will have to pay out of pocket for certain diagnostic genetic tests that their civilian physicians order, but that the Defense Health Agency doesn't view as appropriate or medically necessary.
In January 2013, without notice to beneficiaries or to health care providers, TRICARE stopped reimbursing clinical laboratories for more than 100 different genetic or "molecular pathology" tests.
Beneficiaries haven't complained yet because the laboratories impacted are still providing the tests that physicians order at no charge, said Julie Khani, vice president of American Clinical Laboratory Association (ACLA), which lobbies on behalf of the impacted laboratories.
To date, labs have provided about $10 million worth of free tests to TRICARE users. "That's obviously unsustainable," Khani said. Most of these tests cost about $60 but a few carry charges of several thousand dollars.
Medical science has seen an explosion of clinical tests designed to diagnosis and treat ailments based on a patient's DNA. With thousands of new tests added annually, driven by demand for personalized medicine, the Food and Drug Administration is weighing the need to regulate the industry.
One of the more routine genetic tests that TRICARE no longer covers is used to determine if a woman who is pregnant carries a marker for cystic fibrosis, which would increase chances of the baby having the disease.
If the woman has the marker, the father usually is tested too because both parents must have the CF gene for the fetus to be at risk of CF. If both parents are found to have it, the likelihood of their baby having CF is one in four, according to the Cystic Fibrosis Foundation
With this test no longer covered, "TRICARE beneficiaries will not receive the standard of care or benefits equal to other insured patients," Khani said. The American Congress of Obstetricians and Gynecologists has recommended prenatal testing for CF for more than a decade, she said.
"It's covered by Medicaid and other commercial health plans. It is also the standard of care under VA-DoD clinical practice guidelines for management of pregnancy," Khani said. "Clearly an important test."
The Defense Health Agency disagrees. Though no official was made available to be interviewed, DHA gave written responses to our questions. In one, it dismissed the significance of the prenatal CF testing.
"Awareness that a fetus is at increased risk of having CF, in and of itself, does not usually change the management of labor, delivery and the neonatal period," wrote DHA officials.
Also, they noted, infants at birth are tested for a host of health conditions, including CF, and those tests continue to be covered by TRICARE.
In July, DHA did remove the CF test from its "no government pay" list but DHA has continued to refuse to reimburse laboratories such tests.
Reps. Tom Marino and James P. McGovern, co-chairs of the Congressional Cystic Fibrosis Caucus, urged Lt. Gen. Douglas J. Robb, director of DHA, in a letter signed Monday to reconsider the decision not to cover prenatal CF testing, arguing that "patient care will suffer."
What drove decision by TRICARE last January to stop reimbursing for many genetic or laboratory-developed tests (Lets) was the American Medical Association's publication of new Current Procedural Terminology (CPT) codes for laboratory tests. The codes gave greater transparency to how TRICARE was being billed, DHA said. It could "identify specific laboratory developed tests that 1) have not been approved or cleared by the Food and Drug Administration and/or 2) failed to meet TRICARE criteria for coverage."
For example, DHA said, "demand genetic testing that is not medically necessary or does not assist in medical management of the patient" is not reimbursable. Also, DHA emphasized that TRICARE cannot cover any laboratory developed test that has not been approved by the FDA.
The ACLA criticizes DHA on this point, arguing that TRICARE does cover many other laboratory-developed tests not FDA approved, including pap smears, a routine test for cervical cancer.
The DHA "has a flawed interpretation of its own policy" which "places TRICARE out of step with other government and commercial payers, and it impacts the patient," said Khani. "We are deeply concerned that TRICARE beneficiaries will be denied vital services that are critical to the diagnosis and treatment of disease. And these are tests TRICARE has covered historically."
If TRICARE doesn't begin soon to pay for these tests, doctors won't stop ordering them but laboratories will have no choice but to charge patients for their cost, Khani said.
The Military Coalition, an umbrella group of military associations and veterans groups, recognizes that laboratory profits and some very complex medical questions are entwined in this debate between DHA and industry.
But one clear concern for beneficiary advocates, said Kathy Beasley, co-chair of the coalition's health subcommittee, is that DHA has created two standards of care regarding molecular pathology tests. Patients who use civilian providers will have to pay for these tests, while patients at military clinics and hospitals won't. Providers in the direct care system can continue to order such tests knowing the military will pay for them.
"TRICARE beneficiaries without access to military treatment facilities are relegated to second-class healthcare. This is troubling," Beasley said.
DHA acknowledges this disparity in access to laboratory services between purchased care and direct care. Officials explained that a single contract is in effect that allows Army, Navy and Air Force providers to request lab services if military facilities cannot perform the tests in house.
"As this is not a DHA contract, we are in the process of gathering data regarding the tests being ordered by MTF providers and will examine any changes that need to be made to the contract," DHA said. "Lab testing, whether ordered in the private sector or by MTF providers, needs to be safe and effective."
But DHA said differences in lab test coverage might survive any such review because purchased care has more restrictive laws and regulations.
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