Managed Care - October 2008 - (Page OA7) and anticoagulation clinic management (Heneghan 2006, Ansell 2005, Koertke 2007). There are three Clinical Laboratory Improvement Act (CLIA)waived INR devices that have been FDA-approved for POC home testing. The devices vary with regard to clot-detection method and testing materials, but all require a drop of whole blood applied to a test strip or cuvette, and the INR result is available within minutes. Most devices have onboard quality control and self-diagnostics that simplify their use by patients and caregivers. Variations among results obtained on different instruments, or even identical instruments, are to be expected, and these variations do not invalidate the results of either method or instrument. Likewise, INR devices, like other POC testing devices, are not expected to produce results identical to those of a citrated plasma-based assay, and different sample types will yield statistically different results even on the same instrument. Rather, the devices have been shown to correlate adequately to the reference method within an acceptable range prior to FDA approval (Ansell 2005). Although parallel testing between INR devices and central laboratory methods should not routinely be needed, the panel does recommend periodic parallel testing between a patient’s INR device and the office INR device to document a patient’s continued ability to perform the assay correctly. Table 4 shows some of the CLIAwaived INR instruments available for PST. Training The recent CMS decision to expand PST-related reimbursement for patients with AF or DVT/PE stipulates that patients complete a one-time, faceto-face training program and demonstrate correct use of their INR device. This one-time device training is separate from ongoing patient education on medication, diet, and other aspects of oral anticoagulation therapy management that practitioners routinely provide during regular office visits to all patients, regardless of whether they participate in PST. Topics that should be included in this initial device training are the technique for fingerstick blood collection, device setup and operation, performance of the assay, recording and communicating the INR result, obtaining supplies, and care and storage of the device and supplies. Patients must demonstrate correct operation of the device prior to beginning a home testing program. Ongoing follow-up In addition to regular INR monitoring, a systematic, high-quality, comprehensive patient management system requires periodic visits to a knowl- Summary of consensus panel recommendations Warfarin therapy requires a systematic method of management and follow-up, including regular INR testing Point-of-care testing and PST are enabling technologies that facilitate high-quality management of patients receiving long-term oral anticoagulation therapy Patient self-testing enables more frequent testing that has been shown to improve INR control and reduce the incidence of bleeding and thrombotic complications There is compelling evidence supporting PST in the context of a comprehensive anticoagulation management plan: ° Increased time in therapeutic range ° Reduction of hemorrhagic and thrombotic complications ° Overall cost-effectiveness ° Improved quality of life for patients and their families PST is not an alternative to regular care provided by a medical practitioner; PST provides additional data that allows practitioners to make more informed patient-care decisions An increase in the demand for high-quality management of oral anticoagulation therapy is anticipated in the near future, and the current management methods may be inadequate to provide high-quality care to all the patients who require treatment Medicare reimbursement, although imperfect, is changing in response to the growing body of clinical data supporting PST, and in response to the input of practitioners who understand the value and cost-effectiveness of PST There are many options regarding all aspects of PST, allowing practitioners to tailor implementation to their needs and preferences Elements that are important to successful implementation of PST include: ° Standardized patient selection process that focuses on the medical necessity for those patients or their caregivers who are willing and able to reliably perform PST as prescribed; reliable phone service or other means of communicating with the practitioner ° Initial and ongoing patient education and specific INR device training prior to initiating PST ° Clear, consistent communication between patients and practitioners regarding expectations of patients performing PST and consequences for nonadherence ° A readily accessible means for patients to communicate results to the practitioner’s office ° An office system for managing patient communication and follow-up ° Ongoing patient education and specific INR device training prior to initiating PST SUPPLEMENT / ORAL ANTICOAGULATION 7
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