Diagnostics & Imaging Week Washington Editor

Federal regulators who deal with medical technology rarely get credit for meeting their deadlines, but the Centers for Medicare & Medicaid Services did just that with a recent decision on whether to expand reimbursement for home testing for prothrombin times.

The agency said late last year that it would revisit the question of reimbursement for home-based tests of prothrombin times in patients taking warfarin (Coumadin), which previously was reimbursed only for patients with mechanical heart valves. CMS said at the time it would publish its decision March 19.

CMS made its deadline with a March 19 decision memo stating,"After examining additional evidence, we are expanding Medicare coverage of home prothrombin monitoring to include chronic atrial fibrillation and venous thrombosis."

The agency did, however, attach several conditions. Among these is that Medicare will pay for such coverage so long as that the patient has been on anticoagulation therapy for at least three months and so long as the patient"has undergone a face-to-face education program on anticoagulation management" and has demonstrated the correct use of the test. This last condition formed one of the primary concerns CMS had in approving reimbursement.

The CMS decision memo noted that the medical literature on home self-monitoring has expanded since the 2001 decision for patients on mechanical heart valves, including one study conducted in 2002 that concluded that"no significant differences were found between self-testing and laboratory" tests of prothrombin times. An assessment conducted in 2005 also indicated no significant difference in test results, but also backed the notion that patients would use the test appropriately. Patients were also on record as consistently backing the idea of conducting the tests themselves.

Despite the favorable conclusions drawn from these and other studies, CMS acknowledged that it was concerned about low enrollment rates of"only 10-20% ... from the eligible population" for four of the studies used to support the additional coverage. The agency pointed out that a similar study was terminated"due to low enrollment." CMS described itself as"challenged to generalize the conclusions beyond patients who have demonstrated capability and motivation" to get through the necessary training and to keep up with the tests.

Despite those concerns, CMS has opted to cover such tests, with acting administrator Kerry Weems noting in the agency's accompanying statement that beneficiaries"will benefit greatly through the use of the home test."

Amy Murphy, associate director of media relations at the American College of Cardiology (ACC; Washington) told Diagnostics & Imaging Week"generally, we are pleased that CMS has expanded coverage." The association has weighed in on several aspects of the proposed decision memo, including that it is concerned that out-of-specification results might require the test be done more than once a week, which is the maximum frequency CMS will reimburse.