Managed Care - October 2008 - (Page OA3) tients older than age 60 (White 2003), approximating the current age of the oldest of the baby boom generation. In the United States, the aging of this large segment of the population is expected to result in a significant increase in the incidence of VTE and the need for oral anticoagulation in the coming years. Likewise, the incidence of AF increases after age 40 and more so after age 65 (Albers 2001). The wider implementation of PST may be a critical component of the U.S. health care system’s response to ensure high-quality care for the growing population of patients who will require oral anticoagulant therapy. If Medicare office visit reimbursements become more limited for practitioners treating patients who receive oral anticoagulant therapy, PST would provide a feasible way to maintain high-quality patient management as the reimbursement schedule evolves. In February 2008, a consensus panel consisting of a multidisciplinary group of U.S. health care practitioners with expertise in anticoagulation management was convened to determine the best practices for implementing PST in clinical practice. Their recommendations are presented herein. monitoring for patients with mechanical heart valves. In March 2008, CMS expanded coverage to patients with AF and VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) (CMS 2008). This decision is supported by the American Heart Association, the American Stroke Association, the American College of Cardiology, and the American College of Clinical Pharmacy. The CMS decision states several conditions for reimbursement eligibility, including the patient’s need for chronic oral anticoagulation with warfarin, at least 3 months of therapy prior to beginning PST, successful completion of a face-to-face training program and correct demonstration of device operation, continued proper use of the device in the context of a comprehensive management plan, and a testing frequency of no more than once weekly. The CMS decision was based on 10 clinical studies demonstrating that home testing is associated with consistently higher rates of time in therapeutic range and improved patient outcomes, regardless of the clinical indication or type of INR device used. Among the advantages related to the immediate availability of weekly results with PST, CMS lists: • The ability of the health care practitioner to make dose adjustments quickly • The ability of the patient to correlate lifestyle factors to INR stability • Increased confidence on the part of the practitioner to prescribe sufficient doses of warfarin to achieve the therapeutic range (CMS 2008) Reimbursement is approved for PST-related services in addition to the standard fees for management of patients. Currently, the payment for review of each set of 4 PST results is $9.08; for providing one-time initial device training (described in more detail on page 7), $191.20; and for leasing an INR device and providing testing supplies to the patient, $140.54 per month (Table 2, page 4). Practitioner options Practitioners who implement PST as part of a patient’s overall management plan may choose only to review and evaluate the additional INR results provided by PST, and ask patients to purchase their own devices and supplies and receive device training through a licensed, third-party vendor. Alternatively, they may choose to review results and provide patients with initial device training, but require that they obtain their device and supplies through the third-party vendor. A third option is for the practitioner to review results, purchase the INR devices and then lease them to patients, and make test strips and other supplies available to patients. Table 2 (page 4) shows the PST reimbursement for three different levels of practitioner involvement. Rationale for wider implementation of PST Comparative studies of PST and PSM as an adjuvant to usual care Patient INR self-testing by those who receive oral anticoagulant therapy with warfarin is an effective tool for monitoring therapy and managing dose adjustments. Many clinical studies have demonstrated significant reductions in the risk of bleeding and thrombotic complications when PST is added to a comprehensive care plan, and these management tools are commonly used in several European countries. As an adjuvant to standard medical management by health care practitioners or anticoagulation clinics, weekly INR testing with PST, in addition to the office-based medical evaluation and management provided by primary care practitioners, has been shown to result in better INR control, lower rates of bleeding and thrombotic complications, and superior patient satisfaction. The Centers for Medicare and Medicaid Services (CMS) evaluators noted that within the large body of data collected from randomized controlled trials demonstrating consistently favorable results for PST, no trials have shown a decrease in time in therapeutic range with self-testing (CMS 2008). A summary of selected studies of PST/PSM supporting this claim is presented in Table 1. PST costs and related reimbursement Recent changes in the reimbursement system in the United States have made implementation of PST feasible for a wider range of patients receiving oral anticoagulant therapy and for their health care practitioners. In 2002, CMS approved reimbursement for home INR SUPPLEMENT / ORAL ANTICOAGULATION 3
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