CMS Proposes Coverage for Atrial Fib, DVT Patients

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Tuesday, January 8, 2008

PTINR.com Staff

Medicare’s December 20, 2007 proposal could mean patient self-testing for patients taking warfarin is just around the corner

On December 20, 2007, the Center for Medicare and Medicaid Services (CMS) issued a reimbursement coverage proposal for the monitoring of prothrombin time for Home Anticoagulation Management, via the measurement of international normalized ratio (INR) . ¹

The proposed memo includes coverage of home INR monitoring for patients with atrial fibrillation and deep vein thrombosis. CMS issued a 30-day period for public comment and will consider additional clinical support before reaching a final decision regarding the proposal. ¹

The proposed coverage policy for home INR monitoring for patients with atrial fibrillation or deep vein thrombosis follows the initial coverage policy issued by CMS on July 2, 2002, which provided reimbursement only for patients with mechanical heart valves. ¹ CMS cited 134 comments in favor of additional coverage received during a June 20, 2007 through July 20, 2007 comment period, plus additional clinical trail support. ¹

Public Comment Support

Professional societies submitted their support for expanded coverage of home INR monitoring in the summer of 2007. Both the American Heart Association and American Stroke Association supported the coverage policy proposed by CMS for patients with atrial fibrillation and deep vein thrombosis. ¹

The American College of Cardiology (ACC) recommended support for expanded coverage beyond mechanical heart valve patients. Their recommendations included patients on long duration therapy, specifically identifying atrial fibrillation patients and patients with congenital thrombophilic disorders. The ACC also encouraged CMS to consider coverage for physician services, including adjustments needed during patient home INR monitoring. ¹

The Anticoagulation Forum also supports reimbursement for home INR monitoring, but without regard to the indication for warfarin (Coumadin ®) treatment. “…the Anticoagulation Forum (ACF) was established as a network of professionals involved in direct patient care in the setting of an ACC. The Anticoagulation Forum is a network of physicians, nurses and pharmacists involved in the therapeutic modality of oral anticoagulation therapy and the management of thrombotic disorders.” ²

Finally, the American College of Clinical Pharmacy submitted their support for coverage of all patients with appropriate indications for warfarin treatment. ¹ The proposed National Coverage Determination (NDC) for atrial fibrillation and deep vein thrombosis is independent of the current NCD (190.17) for mechanical heart valve patients. ¹

Coverage Requirements

The proposed CMS coverage policy for INR monitoring in atrial fibrillation and deep vein thrombosis patients includes the same requirements as for patients with mechanical heart valves:

- The beneficiary requires chronic anticoagulation with warfarin for a mechanical heart

valve, chronic atrial fibrillation, or deep vein thrombosis; and

- The beneficiary has been anticoagulated for at least three months prior to the use of the home INR device; and

- The beneficiary has undergone an educational program on anticoagulation management and demonstrates the correct use of the device prior to its use in the home; and

- The beneficiary continues to correctly use the device in the context of management of anticoagulation therapy following initiation of home monitoring; and

- Self-testing with the home INR device occurs no more frequently than once a week. ¹

Home INR testing and related supplies require a physician’s prescription, as well as patient training. Training may be performed by a patient’s physician or by Quality Assured Services, Inc. Home INR monitoring is complimentary to routine physician care, and is part of a comprehensive management program.