Plans by TRICARE to expand coverage of laboratory-developed tests (LDTs) under a new demonstration program have received mixed reaction from lab groups, which say that the program already had authority to cover LDTs. TRICARE, which provides medical services for military families and retirees, announced June 18 that a new demonstration program would allow it to review tests not approved by the Food and Drug Administration (FDA) to determine if they are safe and effective for use. This demonstration, called the Defense Health Agency [DHA] Evaluation of Non-United States Food and Drug Administration Approved Laboratory Developed Tests Demonstration Project, also includes coverage for prenatal and preconception cystic fibrosis, with certain limitations. TRICARE also said that beneficiaries who have paid for LDTs now included in the demonstration since Jan. 1, 2013, are eligible for retroactive reimbursement. According to the announcement, TRICARE generally covers only “medications and medical devices like LDTs reviewed and approved by the [FDA]. The demonstration allows the Defense Department to performs its own evaluation of an [LDT], establish a list of these tests deemed safe and effective, and establish a process to add new tests to that list. TRICARE will maintain and publish a list of approved tests and […]
Plans by TRICARE to expand coverage of laboratory-developed tests (LDTs) under a new demonstration program have received mixed reaction from lab groups, which say that the program already had authority to cover LDTs.
TRICARE, which provides medical services for military families and retirees, announced June 18 that a new demonstration program would allow it to review tests not approved by the Food and Drug Administration (FDA) to determine if they are safe and effective for use. This demonstration, called the Defense Health Agency [DHA] Evaluation of Non-United States Food and Drug Administration Approved Laboratory Developed Tests Demonstration Project, also includes coverage for prenatal and preconception cystic fibrosis, with certain limitations.
TRICARE also said that beneficiaries who have paid for LDTs now included in the demonstration since Jan. 1, 2013, are eligible for retroactive reimbursement.
According to the announcement, TRICARE generally covers only “medications and medical devices like LDTs reviewed and approved by the [FDA]. The demonstration allows the Defense Department to performs its own evaluation of an [LDT], establish a list of these tests deemed safe and effective, and establish a process to add new tests to that list. TRICARE will maintain and publish a list of approved tests and will continually update it as new tests are reviewed and approved for coverage. The regional contractor must preapprove use of the test for it to be covered.”
The American Clinical Laboratory Association (ACLA) said that while it greatly appreciates DHA’s effort to further review certain laboratory tests, it reiterates its view that current regulations already allow for TRICARE coverage of LDTs. In fact, TRICARE, like Medicare, Medicaid, and commercial insurers, has a long history of covering LDTs, which play a critical role in the diagnosis and treatment of disease, said Alan Mertz, ACLA president.
“While ACLA maintains current regulations allow for TRICARE coverage of laboratory-developed tests, if a demonstration project facilitates the restoration of coverage for molecular pathology tests for all TRICARE beneficiaries, then it is important to move forward in this process.”
In January 2013, TRICARE stopped reimbursing clinical laboratories for more than 100 molecular pathology tests when care was obtained from the civilian provider network. Testing services for TRICARE beneficiaries receiving health care at a military treatment facility were not affected. Among services affected were tests for cystic fibrosis, Fragile X syndrome, and other tests considered to be standard of care in the diagnosis and treatment of leukemia and lung and other cancers.
TRICARE’s abrupt change in coverage led to an outpouring of concern from members of Congress, military organizations, medical societies, patient and disease groups, and laboratories, all of whom have urged the DHA to restore TRICARE coverage for these critical tests.
In addition to the demonstration project, S. 2410, the Carl Levin National Defense Authorization Act for Fiscal 2015, includes a provision to clarify DHA’s authority to cover LDTs. ACLA has endorsed that provision and believes its enactment remains necessary despite announcement of the demonstration project by DHA.
The same day that TRICARE announced the demonstration, the Genetic Alliance sent a letter to Congress calling for DHA to restore coverage for the LDTs that have been denied. The letter, signed by a number of consumer and medical organizations, notes that FDA has a longstanding “enforcement discretion” policy with respect to LDTs, under which FDA has “clearly and repeatedly said that it does not require premarket review or clearance for LDTs to be lawfully marketed. There are thousands of LDTs currently legally marketed, which neither have, nor are required to have, FDA clearance or approval.”
Despite acknowledging the important role of LDTs in health care delivery costs, the DHA has denied coverage of these tests for over a year, said the alliance. “In many cases, laboratories have continued to provide testing services to TRICARE patients and are awaiting payment,” wrote Sharon Terry, president and CEO. “In other cases, TRICARE beneficiaries have been forced to absorb one hundred percent of the costs for testing, or seek assistance from patient advocacy organizations. This is unacceptable.”
Takeaway: While it appears that TRICARE may be open to covering lab-developed tests provided to beneficiaries, critics say the program never should have stopped covering them.
