The Centers for Medicare and Medicaid Services has expanded coverage of home prothrombin time (or International Normalized Ratio, INR) testing to include patients who are taking anticoagulation therapy for chronic atrial fibrillation and venous thromboembolism.
Patients must meet certain other criteria, and the home tests can't be used more than once a week, according to the final decision issued by the CMS.
Medicare has covered home prothrombin time testing since 2002, but only for patients with mechanical heart valves. The request for expanded coverage was made in June 2007 by the three main manufacturers of home testing devices—Roche Diagnostics, International Technidyne Corp., and HemoSense Inc. The companies said that there was plenty of new evidence to support home testing for the two other conditions. The CMS agreed.
“Medicare's coverage extension of home blood testing of prothrombin time International Normalized Ratio is based on current evidence for these two conditions,” CMS Acting Administrator Kerry Weems said in a statement. Currently, prothrombin testing is conducted about every 4–6 weeks, primarily in physicians' offices, according to the CMS. Fewer than 5% of patients on anticoagulation therapy monitor prothrombin at home.
“Those Medicare beneficiaries and their physicians managing conditions related to chronic atrial fibrillation or venous thromboembolism will benefit greatly through the use of the home test,” Mr. Weems said.
Roche estimated that Medicare beneficiaries would pay $35 for training in use of at-home devices, and about $30 a month for test strips. Patients who have supplemental Medicare insurance might not have any out-of-pocket costs, the company said in a statement.