Great News for Patients with Atrial Fibrillation

By: Alere Staff

Atrial Fibrillation (AF) is the most common cause of irregular heart rhythm in the United States. The average adult heart rate ranges between 60 -100 beats per minute, but patients with AF may have heart rates between 300-600 beats per minute. In cases of irregular heart rhythm, blood may not move through the heart as quickly as with a normal sinus rhythm, and blood may pool to subsequently form a clot. Therefore, the risk of blood clots is markedly increased in patients with AF. Patients with AF are also five to seven times more likely to have a stroke than people with a regular heart rhythm.1

Now some AF patients can improve their odds of avoiding blood clots and strokes. On March 19, 2008, a national coverage policy entitled, “Decision Memo for Prothrombin Time (INR) Monitor for Home Anticoagulation Management,” was released. The memorandum supports coverage for Medicare patients with AF to perform frequently at home, International Normalized Ratio (INR) testing with a portable INR monitor that has been approved by the US Food and Drug Administration.2

The proposed Medicare coverage required a thorough review of existing clinical support and research studies regarding frequent home INR monitoring1, which highlighted advances, made in patient care over the last 20 years. Supportive clinical trials have led to broader use of warfarin by patients with AF. Consequently, however, bleeding incidents are increasing as this patient population ages.3 When compared to monthly INR monitoring, frequent home testing results in better control of warfarin dosing, which leads to fewer bleeding episodes and a reduced risk of stroke.4

A 2001 decision to provide frequent home INR testing for warfarin patients with mechanical heart valves set the precedent for the 2008 Medicare proposal. As with the 2001 coverage criteria, patients with AF must (1) have a physician’s prescription, and (2) have been taking warfarin for 90 days or more.2 Reimbursement for the monitor and testing supplies requires that the patient completes face-to-face training from a healthcare professional and continue to competently use the device according to a physician’s instructions.2

  1. “Atrial Fibrillation" 2007. retrieved April 15, 2008, from Cleveland Clinic Web site:
  2. Decision Memo for Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087R), March 2008, 1-17.
  3. Hart, R. Anticoagulation in atrial fibrillation: selected controversies including optimal anticoagulation intensity, treatment of cerebral hemorrhage. Journal of Thrombosis and Thrombolysis. 2006. DOI 10.1007/s11239-007-0101-1.
  4. Heneghan C., et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. The Lancet. 2006. 367, 404-411.


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