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'No rationale' for Tricare's refusal to cover genetic tests

Mar. 11, 2014 - 10:37AM   |  
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A change in medical classifications last year has left clinical laboratories across the U.S. carrying a $10 million tab for Tricare.

Tricare beneficiaries have not been billed for certain physician-ordered tests they have received at clinical laboratories since Jan. 1, 2013 — but Tricare also has not paid for them.

At the heart of the standoff are genetic tests developed by laboratories that are not approved by the Food and Drug Administration. Doctors often order these diagnostic molecular tests, such as screenings for cystic fibrosis, some cancers and rare genetic disorders. But the Defense Health Agency says such tests are not cleared and often aren’t “medically necessary.”

Tricare stopped covering the tests after the American Medical Association expanded its medical coding, known as the Current Procedural Terminology, of lab tests. Tricare officials said the change provided “greater clarity” on what the military health system was paying for, and unapproved tests should not be on the list.

But the American Clinical Laboratory Association, an industry group that advocates for members, disagrees. ACLA senior vice president Julie Khani said the decision makes no sense, given that Tricare pays for other non-FDA approved tests — some Pap smears, for example — and also pays for several of these tests at military treatment facilities.

“There is no sound clinical or regulatory rationale for this decision,” Khani said. “The decision should be reversed and coverage restored.”

At least 100 genetic or molecular pathology tests are no longer covered. And with many developed each year, more may be added to the list. The FDA has approved some molecular diagnostic tests but is still discussing how to regulate the growing industry.

In lieu of FDA approval, the Defense Health Agency is developing a pilot project to evaluate whether some of the tests are “medically appropriate.” According to DHA officials, the agency also is reviewing disparities in coverage for Tricare beneficiaries treated at military hospitals and clinics, versus those cared for in the private sector, where the tests are not allowed.

Dr. Jonathan Woodson, assistant secretary of defense for health affairs, assured members of the House Armed Services Committee’s personnel panel on Feb. 26 that care will not be compromised, regardless of where beneficiaries receive treatment.

“None of the beneficiaries will be denied the test that they need to get great care,” Woodson said. “We’re going to harmonize that whole ... issue.”

Lawmakers and the Military Coalition, an umbrella group of military and veterans service organizations, also are pressing the Pentagon for a quick resolution to the problem.

“Many of these tests, such as cystic fibrosis screening, represent the standard of care in professional guidelines. Others are critical in identifying the optimal treatment protocol for common forms of cancer. [The Coalition] fears that failing to cover these diagnostic tests will lead to unnecessary suffering for Tricare beneficiaries,” wrote the heads of 28 military and veterans organizations.

Twenty-one senators and 30 representatives sent a letter March 4 to Defense Secretary Chuck Hagel requesting a change to the reimbursement restriction.

Also pressing for change are Congressional Cystic Fibrosis Caucus Chairs Reps. Tom Marino, R-Pa., and James McGovern, D-Mass., who noted in a letter to DHA Director Air Force Lt. Gen. Doug Robb that DoD’s own clinical practice guidelines recommend that military OB-GYNs screen patients for cystic fibrosis.

“Patient care will suffer,” the pair wrote.

DHA insists it will not.

If a mother is screened for cystic fibrosis and is determined to be a carrier, the positive result necessitates a test for the father. If he also is found to be a carrier, the baby has a one in four chance of having the disease. Results of the genetic test would not change management of the pregnancy, labor and delivery of the child, DHA officials said.

“Patient safety and the health and welfare of our beneficiaries are our top priorities,” DHA spokesman Kevin Dwyer said. “In general, by federal law, Tricare payments are prohibited for health care services that are not medically or psychologically necessary. ... The purpose of this provision is to prevent beneficiaries from being exposed to less than fully developed and tested drugs, devices and/or medical procedures and to avoid the associated risk of unnecessary or unproven treatment.”

He added that DHA will publish new guidance on its new demonstration project to review some of the tests later this year.

Previous pilot programs have allowed Tricare to cover the BRCA gene test for breast and ovarian cancer, the Oncotype DX, to help determine the course of breast cancer treatment, and various tests for colorectal and uterine cancer.

“We recognize that some laboratory developed tests may be medically appropriate, effective and meet the standard of care for our beneficiaries,” Dwyer said.

Khani said the Pentagon should move faster to change its policies to bring them in line with other major insurance programs, “many of which cover these tests.”

“Tricare has no basis to exclude laboratory developed tests from coverage. In fact, FDA has repeatedly stated that it is exercising enforcement discretion and not requiring pre-market approval of [these tests],” she said.

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