News | April 23, 2008

CMS Expands Anticoagulation Monitoring Coverage to AF Patients

April 24, 2008 - Medicare Part B will now cover and pay for meter training, equipment and supplies for most long-term warfarin users who monitor their own PT/INR results at home with portable meters, expanding coverage to include those on anticoagulant medication with chronic atrial fibrillation (AF) and venous thromboembolism.

Medicare previously reimbursed these expenses only for patient self-testers who had mechanical heart valves, but now will include monitoring for patients with AF and venous thromboembolism. The new coverage also opens the door to increased patient access to testing.

"The decision to expand coverage to additional disease states allows physicians to manage more of their patients on warfarin therapy through home testing," said Dr. Alan Jacobson, cardiologist, Loma Linda University School of Medicine. "Studies show that more frequent PT/INR testing leads to improved clinical outcomes. The benefits of providing patients with improved access to testing are reductions in strokes, bleeds and deaths."

According to a 2006 international meta-analysis led by Dr. Carl Heneghan and published in the Lancet, patient self-monitoring of oral anticoagulation leads to a significant one-third reduction in death from all causes. The study also showed that thromboembolism was decreased by 55 percent and major hemorrhage was also decreased.

Studies suggest that anticoagulation patients who self-test may experience fewer complications overall than those who do not because self-testing may increase patient time in therapeutic range. A 2001 study published in Z Kardiol reported that over a two-year period, 80 percent of PT/INR values recorded by mechanical heart valve patients who performed self-testing were in target therapeutic range, compared to only 64.9 percent of PT/INR values monitored by family practitioners.2

Studies also suggest that PT/INR self-testing is just as accurate as testing performed by a healthcare professional. Performance testing with the CoaguChek XS System for patient self-testing showed a 97-percent correlation between results obtained by healthcare professionals and by patients testing themselves in a 2001 study, published by the American Journal of Clinical Pathology, in which there were no significant differences between PT/INR results gathered from the laboratory and self-testing patients.

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