Clinical Policy Title: Prothrombin international normalized ratio self-testing

Transcription

1 Clinical Policy Title: Prothrombin international normalized ratio self-testing Clinical Policy Number: Effective Date: July 1, 2013 Initial Review Date: April 23, 2013 Most Recent Review Date: April 19, 2017 Next Review Date: April 2018 Policy contains: Patient self-testing (PST). Prothrombin time. International normalized ratio (INR). Oral anticoagulation. Related policies: None. ABOUT THIS POLICY: Keystone First has developed clinical policies to assist with making coverage determinations. Keystone First s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Keystone First when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Keystone First s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Keystone First s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Keystone First will update its clinical policies as necessary. Keystone First s clinical policies are not guarantees of payment. Coverage policy Keystone First considers the use of patient self-testing (PST) of prothrombin INR measurement to be clinically proven and, therefore, medically necessary as an alternative to office- or laboratory-based testing when all of the following criteria are met: The individual requires chronic oral anticoagulation therapy with warfarin for one of the following conditions: - A mechanical heart valve. - Chronic atrial fibrillation. - Venous thromboembolism. The individual has been treated with an anticoagulant for at least three months prior to use of the home PST of prothrombin INR device. The PST device is approved by the U.S. Food and Drug Administration for home use selftesting of prothrombin INR monitoring. The individual or his or her caregiver meets all of the following criteria: 1

2 - Has undergone a face-to-face educational program on anticoagulation management. - Must be able to demonstrate the correct use of the PST device prior to its use in the home. - Must be able to demonstrate correct use of the PST device in the context of anticoagulation therapy management following initiation of home monitoring. The individual experiences hardship accessing office- or laboratory-based testing related to being homebound, mobility limitations, distance, or living where home health services are not available. PST monitoring with the device occurs no more frequently than once a week. Limitations: All other uses of PST of prothrombin INR monitoring are not medically necessary. Given that the half-life of warfarin is approximately 1.5 days and it typically requires three to four half-lives to reach steady state, it would generally not be necessary to test more than once a week in a patient who is beyond the initial titration period. An exception may be made, as per the American College of Cardiology, for those individuals with a congenital thrombophilic disorder who are being treated with warfarin, as individuals with this condition are at a high risk of bleeding. PST of prothrombin INR measurement would not be appropriate for individuals, or their caregivers, who are unable to complete the training on the use of the device. This Clinical Policy does not address PST of prothrombin INR by individuals with porcine valve replacement. Alternative covered services: Testing for prothrombin time (PT)/INR values in a physician office or laboratory setting. Background Coagulation disorders may cause excessive bleeding or the obstruction of vessels by clot formation. Excessive clot formation may occur in the presence of liver disease, deficiencies in vitamin K, or malabsorption illnesses, and it may place the individual at an increased risk of stroke and myocardial injury. PT is used to assess an individual s coagulation status. PT refers to the amount of time it takes for a clot to form after the addition of the platelet tissue factor, and a range time of 10 to 14 seconds is considered normal. PT testing and its normalized correlate, the INR, are the standard measurements for reporting blood clotting time. The INR allows providers to monitor clotting time in a patient independent of the laboratory reagents used. An INR value of 0.8 to 1.2 is considered normal without 2

3 the presence of anticoagulation therapy. Target ranges for an INR with anticoagulant therapy are usually 2.0 to 3.0 or, for more extreme conditions such as a mechanical heart valve, 2.5 to 3.5 (Holbrook, 2012). Anticoagulation therapy includes the use of drugs (blood thinners) that affect a person s vitamin K- dependent clotting factors. The duration of anticoagulation treatment for an individual varies with the underlying medical condition and response to therapy. Certain conditions require anticoagulation therapy for a brief period of a few months, while other conditions require long-term or possibly lifelong anticoagulation therapy. Warfarin, also referred to by its trade names, e.g., Coumadin (Bristol-Myers Squibb, New York, NY), is an anticoagulant classified as a coumarin and is commonly prescribed for individuals with medical conditions such as mechanical heart valves, atrial fibrillation with thromboembolic risk factors, and the occurrence of venous thromboembolism that may or may not be due to other clotting disorders. Warfarin may pose serious risks to patient safety due to the inter-related complexities of patient compliance and lack of understanding, its narrow therapeutic index, dosing, monitoring, and dietary and drug interactions. Highly individualized treatment regimens may lead to frequent testing, particularly when beginning warfarin therapy or making frequent changes. Generally, warfarin monitoring is recommended once every four to six weeks, taking into account a practical balance between the burden of frequent testing and the risk of adverse events. Systematic management models (e.g., anticoagulation clinics) have emerged to optimize warfarin effectiveness and minimize related complications. Most of these models require that patients come to a clinic for in-person testing and evaluation, thus making this model of care difficult to access and time-consuming for many patients (Nutescu, 2011). Portable self-monitors using finger-prick blood sampling allow for PST in the home (International Self- Monitoring Association of Oral Anticoagulated Patients [ISMAAP], 2017). Individuals who engage in PST for prothrombin INR measurement can adjust their medication according to a predetermined dose-inr schedule (self-management) or call a clinic for appropriate dose adjustment (prothrombin selfmonitoring [PSM]). Home management that includes PST of prothrombin INR monitoring is usually focused on patients needing long-term or lifelong coagulation therapy. Searches Keystone First searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). 3

4 We conducted searches on February 7, Search terms were: Prothrombin, self-testing, home monitoring, Self Care [MeSH], and Blood Coagulation Tests [MeSH]. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings There is sufficient evidence to support the use of PST of prothrombin INR measurement in the context of home monitoring for select individuals with conditions that require oral anticoagulation therapy beyond a three-month period. The Home INR Study (THINRS) conducted by the Department of Veterans Affairs (VA) is the largest trial of its kind comparing PST with standard care (Dolor, 2010). The randomized trial included 28 VA medical centers and 2,922 patients seen for PST or treatment management at a specialty anticoagulation clinic. The primary endpoint was time to the first event, major bleed, stroke, or death. There were no significant differences in the time to first event curves between groups. However, time in target range and patient satisfaction were measurably higher in the PST group. Several systematic reviews have examined the safety and efficacy of home monitoring of anticoagulant therapy (Bloomfield, 2011a and 2011b; Garcia-Alamino, 2010; Brown, 2007; Odegaard, 2004; Siebenhofer, 2004). These analyses found that PSM is safe and offered at least comparable oral anticoagulation control to that provided by a specialized anticoagulation clinic. In comparison with routine care by general internists, self-managed care was superior and improved treatment-related quality of life. PSM, which included PST, improved the percentage of mean INR measurement in the therapeutic range compared to standard monitoring and reduced the number of thromboembolic events and mortality without increases in harms. However, PSM or self-management was not feasible for up to half of the patients requiring anticoagulant therapy. Reasons included patient refusal, exclusion by their general practitioner, and inability to complete training. A subsequent individual patient data analysis further substantiates these findings (Heneghan, 2012). Successful home monitoring of PT with a PST device required adequate levels of cognition and manual dexterity. Training a caregiver modestly increased the proportion of patients who can perform PST. Factors associated with failure to pass PST training included increased age, previous stroke history, poor cognition, and poor manual dexterity (Dolor, 2010). 4

5 The ISMAAP position statement for oral anticoagulation contains several points in favor of PST and PSM (ISMAAP, 2015). The ISMAAP cites a higher degree of medical safety, increased patient education, improved response to changes in lifestyle, increased independence for the patient, and improved quality of life with PST and PSM. The American College of Chest Physicians issued a weak recommendation for use of patient self-management, including PST, rather than usual outpatient INR monitoring for patients treated with vitamin K antagonists who are motivated and can demonstrate competency in selfmanagement strategies based on moderate-quality evidence (Holbrook, 2012). These results suggest the importance of careful patient selection and adequate training to optimize care outcomes for persons who monitor long-term oral anticoagulation therapy using portable PST prothrombin INR measurement. Policy updates: Keystone First identified one new evidence-based guideline from the British Committee for Standards in Haematology (Jennings, 2014) and one Cochrane review update (Heneghan, 2016; update of Garcia- Alamino, 2010) but no new economic studies. Their findings and recommendations for PST of prothrombin INR measurement are consistent with the current policy. Therefore, no changes to the policy are warranted. Summary of clinical evidence: Citation Heneghan (2016) Cochrane review Self-monitoring and selfmanagement of oral anticoagulation Bloomfield (2011a and b) PST with or without PSM versus anticoagulation clinics or non- Content, Methods, Recommendations Key points: Systematic review and meta-analysis of 28 randomized controlled trials (RCTs) with 8,950 total participants. Overall quality: low to moderate. Moderate quality evidence showed a reduction in thromboembolic events: pooled relative risk (RR) 0.58, 95% confidence interval (CI) 0.45 to 0.75; 7,594 patients; 18 RCTs. - Self-management only: RR 0.47, 95% CI 0.31 to 0.70, 3,497 patients, 11 RCTs. - Self-monitoring only: RR 0.69, 95% CI 0.49 to 0.97, 4,097 patients, seven RCTs. Moderate quality evidence showed self-management reduced all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84, 3,058 patients, eight RCTs), but self-monitoring did not (RR 0.94, 95% CI 0.78 to 1.15, 3,300 patients, three RCTs). Moderate quality evidence showed no reduction in major hemorrhage for either intervention: pooled RR 0.95, 95% CI 0.80 to 1.12, 8,018 patients, 20 RCTs. Key points: Systematic review and meta-analysis of 27 references reporting on 22 distinct RCTs. Overall quality: moderate for the thromboembolism and bleeding, low for mortality outcomes. Limitations: In one half of the trials, < 50% of the potentially eligible patients were randomly assigned. Only five trials were considered high quality, and only two were conducted in the United States. No studies addressed safety of PST or PSM during the high-risk initiation phase. Compared to usual clinic care, PST with or without PSM is associated with significantly fewer 5

6 Citation specialized clinics Brown (2007) for the Canadian Agency for Drugs and Technologies in Health Point-of-care (POC) devices versus anticoagulation clinics Content, Methods, Recommendations deaths and thromboembolic events without any increase in bleeding complications for a select group of motivated patients requiring long-term anticoagulation therapy with vitamin K antagonists. Whether this care model is cost effective and can be implemented successfully in typical U.S. health care settings requires further study. Key points: Systematic review of 16 RCTs. Overall quality: low to moderate. Only eight studies compared POC testing to anticoagulation clinics, unclear blinding, short follow-up in 10 studies one year, test frequency higher in POC strategies than in conventional testing. POC devices used to manage oral anticoagulation therapy result in significantly fewer deaths and thromboembolic events, and better INR control, than conventional laboratory testing. The impact of POC devices on hemorrhagic events, however, is similar to conventional testing. References Professional society guidelines/other: Ansell J, Jacobson A, Levy J, Voller H, Hasenkam JM. Guidelines for implementation of patient selftesting and patient self-management of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation. Int J Cardiol. 2005; 99(1): Bonow RO, Carabello BA, Chatterjee K, et al Focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease): endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2008; 118(15): e Briggs C, Guthrie D, Hyde K, et al. Guidelines for point-of-care testing: haematology. Br J Haematol. 2008; 142(6): Holbrook A, Schulman S, Witt DM, et al. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(2 Suppl): e152s 184S. 6

7 Jennings I, Kitchen D, Keeling D, Fitzmaurice D, Heneghan C. Patient self-testing and self-management of oral anticoagulation with vitamin K antagonists: guidance from the British Committee for Standards in Haematology. Br J Haematol. 2014; 167(5): Keeling D, Baglin T, Tait C, et al. Guidelines on oral anticoagulation with warfarin - fourth edition. Br J Haematol. 2011; 154(3): Available at: Accessed February 7, Peer-reviewed references: Bloomfield HE, Krause A, Greer N, et al. Meta-analysis: effect of patient self-testing and selfmanagement of long-term anticoagulation on major clinical outcomes. Ann Intern Med. 2011; 154(7): (a) Bloomfield HE, Taylor BC, Krause A, et al. Safe and Effective Anticoagulation in the Outpatient Setting: A Systematic Review of the Evidence. VA-ESP Project #09-009; National Center for Biotechnology Information website. Accessed February 7, 2017.(b) Brown A, Wells P, Jaffey J, et al. Point-of-care monitoring devices for long-term oral anticoagulation therapy: Clinical and cost effectiveness. Technology Report No. 72. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); February CADTH website. Accessed February 7, Dolor RJ, Ruybalid RL, Uyeda L, et al. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481 The Home INR Study (THINRS). J Thromb Thrombolysis. 2010; 30(3): Garcia-Alamino JM, Ward AM, Alonso-Coello P, et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev. 2010(4): CD Heneghan CJ, Garcia-Alamino JM, Spencer EA, et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev. 2016; 7: Cd Heneghan C, Ward A, Perera R, et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet. 2012; 379(9813): The International Self-Monitoring Association of Oral Anticoagulated Patients (ISMAAP) homepage. Updated February 5, ISMAAP website. Accessed February 7,

8 Nutescu EA, Bathija S, Sharp LK, Gerber BS, Schumock GT, Fitzgibbon ML. Anticoagulation patient selfmonitoring in the United States: considerations for clinical practice adoption. Pharmacotherapy. 2011; 31(12): Odegaard KJ. [Self-management in anticoagulation--a meta-analysis]. Tidsskr Nor Laegeforen. 2004; 124(22): Siebenhofer A, Berghold A, Sawicki PT. Systematic review of studies of self-management of oral anticoagulation. Thrombosis and Haemostasis. 2004; 91: CMS National Coverage Determinations (NCDs): Home Prothrombin Time/International Normalized Ratio (PT/INR) Monitoring for Anticoagulation Management. CMS website. Accessed February 7, Decision Memorandum, CAG-00078N. March 19, CMS website. nagement&ncdid=269&ncdver=2&ispopup=y&bc=aaaaaaaaeaaa&. Accessed February 7, Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments N/A ICD-10 Code Description Comments D68.52 Prothrombin gene mutation. D68.59 Other primary thrombophilia. D68.61 Antiphospholipid syndrome. D68.62 Lupus anticoagulant syndrome. I26.01 Septic pulmonary embolism with acute cor pulmonale. I26.09 Other pulmonary embolism with acute cor pulmonale. I26.90 Septic pulmonary embolism without acute cor pulmonale. 8

9 ICD-10 Code Description Comments I26.99 Other pulmonary embolism without acute cor pulmonale. I48.0 Paroxysmal atrial fibrillation. I48.2 Chronic atrial fibrillation. I80.00 Phlebitis and thrombophlebitis of superficial vessels of unspecified lower I80.01 Phlebitis and thrombophlebitis of superficial vessels of right lower I80.02 Phlebitis and thrombophlebitis of superficial vessels of left lower I80.03 Phlebitis and thrombophlebitis of superficial vessels of lower extremities, bilateral. I80.10 Phlebitis and thrombophlebitis of unspecified femoral vein. I80.11 Phlebitis and thrombophlebitis of right femoral vein. I80.12 Phlebitis and thrombophlebitis of left femoral vein. I80.13 Phlebitis and thrombophlebitis of femoral vein, bilateral. I Phlebitis and thrombophlebitis of unspecified deep vessels of right lower I Phlebitis and thrombophlebitis of unspecified deep vessels of left lower I Phlebitis and thrombophlebitis of unspecified deep vessels of lower extremities, bilateral. I Phlebitis and thrombophlebitis of unspecified deep vessels of unspecified lower I Phlebitis and thrombophlebitis of right popliteal vein. I Phlebitis and thrombophlebitis of left popliteal vein. I Phlebitis and thrombophlebitis of popliteal vein, bilateral. I Phlebitis and thrombophlebitis of unspecified popliteal vein. I Phlebitis and thrombophlebitis of right tibial vein. I Phlebitis and thrombophlebitis of left tibial vein. I Phlebitis and thrombophlebitis of tibial vein, bilateral. I Phlebitis and thrombophlebitis of unspecified tibial vein. I Phlebitis and thrombophlebitis of other deep vessels of right lower I Phlebitis and thrombophlebitis of other deep vessels of left lower I Phlebitis and thrombophlebitis of other deep vessels of lower extremity, bilateral. I Phlebitis and thrombophlebitis of other deep vessels of unspecified lower I82.0 Budd-Chiari syndrome. I Acute embolism and thrombosis of superior vena cava. I Chronic embolism and thrombosis of superior vena cava. I Acute embolism and thrombosis of inferior vena cava. I Chronic embolism and thrombosis of inferior vena cava. I Acute embolism and thrombosis of other thoracic veins. I Chronic embolism and thrombosis of other thoracic veins. I82.3 Embolism and thrombosis of renal vein. 9

10 ICD-10 Code Description Comments I Acute embolism and thrombosis of unspecified deep veins of right lower I Acute embolism and thrombosis of unspecified deep veins of left lower I Acute embolism and thrombosis of unspecified deep veins of lower extremity, bilateral. I Acute embolism and thrombosis of unspecified deep veins of unspecified lower I Acute embolism and thrombosis of right femoral vein. I Acute embolism and thrombosis of left femoral vein. I Acute embolism and thrombosis of femoral vein, bilateral. I Acute embolism and thrombosis of unspecified femoral vein. I Acute embolism and thrombosis of right iliac vein. I Acute embolism and thrombosis of left iliac vein. I Acute embolism and thrombosis of iliac vein, bilateral. I Acute embolism and thrombosis of unspecified iliac vein. I Acute embolism and thrombosis of right popliteal vein. I Acute embolism and thrombosis of left popliteal vein. I Acute embolism and thrombosis of popliteal vein, bilateral. I Acute embolism and thrombosis of unspecified popliteal vein. I Acute embolism and thrombosis of right tibial vein. I Acute embolism and thrombosis of left tibial vein. I Acute embolism and thrombosis of tibial vein, bilateral. I Acute embolism and thrombosis of unspecified tibial vein. I Acute embolism and thrombosis of other specified deep vein of right lower I Acute embolism and thrombosis of other specified deep vein of left lower I Acute embolism and thrombosis of other specified deep vein of lower extremity, bilateral. I Acute embolism and thrombosis of other specified deep vein of unspecified lower I82.4Y1 Acute embolism and thrombosis of unspecified deep veins of right proximal lower I82.4Y2 Acute embolism and thrombosis of unspecified deep veins of left proximal lower I82.4Y3 Acute embolism and thrombosis of unspecified deep veins of proximal lower extremity, bilateral. I82.4Y9 Acute embolism and thrombosis of unspecified deep veins of unspecified proximal lower I82.4Z1 Acute embolism and thrombosis of unspecified deep veins of right distal lower I82.4Z2 Acute embolism and thrombosis of unspecified deep veins of left distal lower 10

11 ICD-10 Code Description Comments I82.4Z3 Acute embolism and thrombosis of unspecified deep veins of distal lower extremity, bilateral. I82.4Z9 Acute embolism and thrombosis of unspecified deep veins of unspecified. distal lower I Chronic embolism and thrombosis of unspecified deep veins of right lower I Chronic embolism and thrombosis of unspecified deep veins of left lower I Chronic embolism and thrombosis of unspecified deep veins of lower extremity, bilateral. I Chronic embolism and thrombosis of unspecified deep veins of unspecified lower I Chronic embolism and thrombosis of right femoral vein. I Chronic embolism and thrombosis of left femoral vein. I Chronic embolism and thrombosis of femoral vein, bilateral. I Chronic embolism and thrombosis of unspecified femoral vein. I Chronic embolism and thrombosis of right iliac vein. I Chronic embolism and thrombosis of left iliac vein. I Chronic embolism and thrombosis of iliac vein, bilateral. I Chronic embolism and thrombosis of unspecified iliac vein. I Chronic embolism and thrombosis of right popliteal vein. I Chronic embolism and thrombosis of left popliteal vein. I Chronic embolism and thrombosis of popliteal vein, bilateral. I Chronic embolism and thrombosis of unspecified popliteal vein. I Chronic embolism and thrombosis of right tibial vein. I Chronic embolism and thrombosis of left tibial vein. I Chronic embolism and thrombosis of tibial vein, bilateral. I Chronic embolism and thrombosis of unspecified tibial vein. I Chronic embolism and thrombosis of other specified deep vein of right lower I Chronic embolism and thrombosis of other specified deep vein of left lower I Chronic embolism and thrombosis of other specified deep vein of lower extremity, bilateral. I Chronic embolism and thrombosis of other specified deep vein of unspecified lower I82.5Y1 Chronic embolism and thrombosis of unspecified deep veins of right proximal lower I82.5Y2 Chronic embolism and thrombosis of unspecified deep veins of left proximal lower I82.5Y3 Chronic embolism and thrombosis of unspecified deep veins of proximal lower extremity, bilateral. I82.5Y9 Chronic embolism and thrombosis of unspecified deep veins of unspecified proximal lower 11

12 ICD-10 Code Description Comments I82.5Z1 I82.5Z2 I82.5Z3 I82.5Z9 I I I I I I Chronic embolism and thrombosis of unspecified deep veins of right distal lower Chronic embolism and thrombosis of unspecified deep veins of left distal lower Chronic embolism and thrombosis of unspecified deep veins of distal lower extremity, bilateral. Chronic embolism and thrombosis of unspecified deep veins of unspecified distal lower Acute embolism and thrombosis of unspecified veins of right upper Acute embolism and thrombosis of unspecified veins of left upper Acute embolism and thrombosis of unspecified veins of upper extremity, bilateral. Acute embolism and thrombosis of unspecified veins of unspecified upper Acute embolism and thrombosis of deep veins of right upper Acute embolism and thrombosis of deep veins of left upper I Acute embolism and thrombosis of deep veins of upper extremity, bilateral. I Acute embolism and thrombosis of deep veins of unspecified upper I Chronic embolism and thrombosis of unspecified veins of right upper HCPCS Level II Description Comments G0248 G0249 G0250 Demonstration, prior to initiation of home INR monitoring for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria, under the direction of a physician; includes: face-to-face demonstration of use and care of the INR monitor, obtaining at least one blood sample, provision of instructions for reporting home INR tests results, and documentation of patient s ability to perform testing and report results. Provision of test materials and equipment for home INR monitoring of patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; includes: provision of materials for use in the home and reporting of test results to physician; testing not occurring more frequently than once a week; testing materials, billing units of service include four tests. Physician review, interpretation, and patient management of home INR testing for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria, testing not occurring more frequently than once a week; billing units of service include four tests. Patient education and training; demonstration of monitor. Provide test material; meter and strips. Professional review and interpretation. 12