Read National Medical Policy text version

Posted: March 2011

National Medical Policy

Subject: Policy Number: Home Prothrombin and INR Monitoring NMP489

Effective Date*: February 2005 Updated: January 2007, December 2008, March 2011

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicare Advantage members please refer to the following for coverage guidelines first: Use X Source

National Coverage Decision

The Centers for Medicare & Medicaid Services (CMS)

Reference/Website http://www.cms.gov/medicare-coveragedatabase/details/ncddetails.aspx?NCDId=269&ncdver=2&SearchType=Ad vanced&CoverageSelection=National&NCSelection=N CD&KeyWord=Home+Prothrombin+and+INR+Monito ring&KeyWordLookUp=Doc&KeyWordSearchType=Or &kq=true&bc=IAAAACAAAAAA& HOME PROTHROMBIN Time/International Normalized Ratio (PT/INR) MONITORING for Anticoagulation Management (190.11)

CMS Manuals (i.e. Benefits) Local Coverage Decision (Use HN policy if there are no LCDs in your region) Article (Local)

Other

None

Use Health Net Policy

Instructions · Medicare NCDs and Benefit Manuals apply to ALL Medicare members in ALL regions. · Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website, then enter the topic and your specific state to find the coverage instructions for your region. · If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or Benefit Manual.

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Posted: March 2011 · If there is no NCD, Benefit Manual or LCD specific to your region, please use Health Net National Medical Policy.

Current Policy Statement (Update March 2011 ­ A Medline search failed to

reveal any studies that would cause Health Net, Inc. to change its current position)

Commercial Members Health Net, Inc. considers prothrombin time (PT) or international normalization ratio (INR) home testing systems medically necessary for selected high-risk patients who will be receiving long-term anticoagulation therapy with warfarin (coumadin) for 3 months (usually lifetime) and who have instability in the degree of anticoagulation with wide fluctuations in their response to warfarin (coumadin) for any of the following conditions*: 1. Patients with mechanical heart valves (porcine, or pig valves, rarely require anticoagulation; or 2. Patients who have had deep venous thrombosis or pulmonary embolus; or 3. Prevent recurrence of strokes; or 4. Prevent or treat thromboembolic events in patients with chronic or recurrent atrial flutter / fibrillation or 5. Children with congenital heart disease; or 6. Other conditions requiring consistent and aggressive warfarin therapy to an INR level of greater than 3. The patient must undergo an educational program on anticoagulation management and the use of the device prior to its use in the home. The patient must undergo a face-to-face educational program on anticoagulation management and must have demonstrated the correct use of the device prior to its use in the home. The patient continues to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring. Self-testing with the device should not occur more frequently than once a week and the patient should have the PT or INR periodically checked at a professional facility in order to make sure that the monitor is well equilibrated. *Note: Consideration may be given to individuals who are homebound due to medical reasons for the duration of treatment, or individuals who have a hardship due to a lengthy drive from their place of residence to a network facility or office capable of providing the service when frequent prothrombin time monitoring (e.g., weekly or bi-weekly) is required. Note: The purpose of home measurement of PT or INR is so that the patient can provide the monitoring information to their clinician (or in some cases, a pharmacist), who will consider the reported values in making adjustments to the patient's warfarin dose. Home monitoring is not intended to provide patients with information in order to adjust their own warfarin doses.

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Posted: March 2011

Codes Related To This Policy ICD-9 Codes

289.81 Primary hypercoagulable state 394.0-394.9 Mitral valve disease 395.0-395.9 Aortic valve disease 396.0-396.9 Diseases of mitral and aortic valves 415.0-415.19 Pulmonary embolisms and infarction 424.0 Mitral valve disorders 427.31 Atrial fibrillation 427.9 Dysrhythmias 429.0-429.4 Ill-defined descriptions and complications of heart disease 429.79 Other certain sequelae of myocardial infarction, not elsewhere classified 434.00-434.91 Occlusion of cerebral arteries 437.0 Cerebral atherosclerosis 437.1 Other generalized ischemic cerebrovascular disease 438 Late effects of cerebrovascular disease (old CVA) 444.0-444.9 Arterial embolism and thrombosis 451.0-451.9 Phlebitis and thrombophlebitis 453.0-453.9 Other venous embolism and thrombosis 673.00-673.84 Obstetrical pulmonary embolism 746.00-746.9 Congenital anomalies of heart 964.2 Poisoning by anticoagulant 995.2 Unspecified adverse effect of drug, medicinal and biological substance (due to correct medicinal substance properly administered) V15.1 Personal history of surgery to heart and great vessels V42.2 Prosthetic valve replacement V43.3 Heart valve replaced by other means V58.61 Long-term (current) use of anticoagulants

CPT Codes

85610

Prothrombin time

HCPCS Codes

E1399 G0248

G0249

G0250

Durable medical equipment, miscellaneous Demonstration, at initial use, of home INR monitoring for patient with mechanical heart valve (s) who meets Medicare coverage criteria, under the direction of a physician; includes: demonstration use and care of the INR monitor, obtaining at least one blood sample, provision of instructions for reporting home INR test results and documentation of a patient ability to perform testing. Provision of test material and equipment for home INR monitoring to patient with mechanical heart valve (s) who meets medicare coverage criteria. Includes provision of materials for use in the home and reporting of test results to physician; per 4 tests (does not require face-to-face service) Physician review, interpretation and patient management of home INR testing for a patient with mechanical heart valve (s) who meets other coverage criteria; per 4 tests (does not require face-to-face service)

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Scientific Rationale Update ­ March 2011

Ryan et al. (2010) completed a randomized, crossover patient self-testing (PST) study at Cork University Hospital; patients were randomized to 6 months PST or 6 months routine care by the anticoagulation management service. During the PST arm of the study, patients measured their INR at home using the CoaguChek S or XS point-of-care (POC) meter. External quality control was performed at enrollment, 2 months and 4 months by comparing the POC measured INR with the laboratory determined value. One hundred and fifty-one patients provided 673 paired samples. Good correlation was shown between the two methods of determination (r = 0.91), however, statistically significant differences did occur. A Bland-Altman plot illustrated good agreement of INR values between 2.0 and 3.5 INR units but there was increasing disagreement as the INR rose above 3.5. Eighty-seven per cent of all dual measurements were within the recommended 0.5 INR units of each other. This study adds to the growing evidence that POC testing is a reliable and safe alternative to hospital laboratory monitoring but highlights the importance of external quality control when these devices are used for monitoring oral anticoagulation. Matchar et al. (2010) randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death. The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinictesting group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001). As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin therapy. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT00032591). Hayes has a Medical Technology Directory (2006, updated 2010) in which the following ratings* for self-monitoring of oral anticoagulant therapy is noted: A - For self-monitoring of oral anticoagulant therapy in adult patients with heart valve replacement or deep vein thrombosis, who are highly motivated, successfully participate in a training program, and demonstrate sufficient ability to perform self-testing correctly. B - For self-monitoring combined with self-management of oral anticoagulation therapy in adult patients with heart valve replacement or deep vein thrombosis, who are highly motivated, successfully participate in a training program, and demonstrate sufficient ability to perform self-testing and self-management correctly.

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Posted: March 2011 B - For self-monitoring with or without self-management of oral anticoagulation therapy in adult patients, who have other indications for long-term anticoagulant therapy. C - For self-monitoring with or without self-management of oral anticoagulation therapy in pediatric patients; this lower rating reflects the limited evidence regarding prothrombin time self-monitoring in these patients. D - For self-monitoring with or without self-management of anticoagulation therapy in patients, who are not capable of performing self-testing/selfmanagement reliably or who have other specific contraindications to self-testing. *Notes: Hayes ratings are as not below: A - Established benefit. A high level of positive published evidence regarding safety and efficacy supports use of the technology for the cited application(s). Drugs, biologics, and devices with an A rating have FDA approval, but not necessarily for the specific clinical application. B - Some proven benefit. A moderate level of positive published evidence regarding safety and efficacy supports use of the technology for the cited application(s). Further research is required to fully clarify clinical indications, contraindications, treatment parameters, comparison with other technologies, and/or impact on health outcomes. Drugs, biologics, and devices with a B rating have FDA approval, but not necessarily for the specific clinical application. C - Potential but unproven benefit. Some positive published evidence regarding safety and/or efficacy support use of the technology for the cited application(s), but a beneficial impact on health outcomes has not been proven because data are sparse and the level of evidence is low, or data are inconsistent or conflicting. D - No proven benefit and/or not safe. This rating conveys one of two conclusions: (1) The technology has been shown to be unsafe and/or published evidence does not show that its use improves health outcomes; or (2) The research regarding use of the technology is so limited that an appraisal of safety and efficacy cannot be made.

Scientific Rationale Initial

Warfarin (Coumadin) is an oral compound of significant medical importance. Over the last 40 years, thousands have used it for anti-coagulant therapy, and used it safely and effectively, to prevent venous and arterial thrombosis clinically presenting as strokes, heart attacks, deep venous thrombosis, pulmonary emboli, and other disorders. It decreases the tendency of the blood to clot, and is very potent in doing so. However, it is a medication that must be taken maintained within the therapeutic range to minimize adverse events associated with inadequate or excessive anticoagulation such as serious bleeding or thromboembolic events. Monitoring of the prothrombin time (PT), or the International Normalized Ratio (INR), is recommended to ensure that the dose levels remain within the therapeutic range. The PT evaluates the extrinsic coagulation system, i.e., Factors V, VII, X, prothrombin and fibrinogen. Use of the International Normalized Ratio (INR) allows physicians to determine the level of anticoagulation in a patient independent of the laboratory reagents used. The INR is the ratio of the patient's prothrombin time compared to the mean prothrombin time for a group of normal individuals. These tests require periodic repetition at intervals that vary from person to person to avoid severe thromboembolic and Home Prothrombin and INR Monitoring Mar 11

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Posted: March 2011 hemorrhagic complications due to intense oral anticoagulation and fluctuating individual INR values around the target range. Prothrombin time home testing systems are portable, battery-operated instruments for the quantitative determination of prothrombin time from fingerstick whole blood. FDA approved portable testing devices that are available by prescription for home use to aid in the management of high-risk patients taking oral anticoagulants include: (1) ProTIME microcoagulation analyzer; (2) Harmony INR Monitoring System and Rubicon PT Monitoring System; (3) CoaguChekTM System; and (4) INRatio System. The FDA approval for all of these devices was based on the demonstration that appropriately trained patients could generate INR test results comparable to laboratory values and allows more frequent monitoring and selfmanagement of warfarin therapy with the ultimate goals of increasing the time that the anticoagulation is within a therapeutic INR range and decreasing the incidence of thromboembolic or hemorrhagic events. Several randomized, controlled studies have compared home prothrombin time monitoring to either monitoring in a physician's office or monitoring in specialized coagulation clinics. Their conclusions were that a home prothrombin time monitoring device achieved a clinically acceptable level of accuracy when compared to traditional lab methods and provides a suitable alternative method of monitoring. Published studies have primarily focused on the intermediate outcome of time spent in the therapeutic range of warfarin, as measured by INR, rather than the incidence of hemorrhagic or embolic events since these are of low incidence. The results of these trials have all demonstrated that self-monitoring and management were associated with an increase in the PT "time therapeutic range" from 6% to 34%. Another study confirms that the proportion of the treatment time during which the INR was within the therapeutic range (2.0 to 3.0) was higher in the intervention group than in the usual care group. Treatment-related quality-of-life measures, especially treatment-satisfaction scores, were significantly higher in the intervention group compared to controls. Two of the larger trials also reported a decrease in adverse outcomes. One randomized trial has also shown that self-management of coumadin with home protime devices reduced complications requiring hospitalization by 40% over traditional care given by a physician in patients who had received mechanical heart valves. At the 17th congress of the International Society on Thrombosis and Hemostasis (1999), a group of international experts reported on the developments in patient PT self-testing and self-management in their respective countries. They concluded that: "PT self-management and self-monitoring of oral anticoagulant therapy has the potential to improve therapeutic control and decrease hemorrhagic and thromboembolism adverse events. As a result, there would be improved patient-satisfaction with treatment and a decrease in the labor-intensive monitoring by physicians and facilities." The cumulative evidence from clinical studies undoubtedly indicates that PT selfmonitoring with whole-blood portable home PT testing devices is feasible and accurate and has consistently shown that, in a select group of motivated patients given adequate training and support, the use of these systems results in an increased time in the therapeutic range, probably leading to a reduction in hemorrhagic or embolic events.

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Posted: March 2011

Review History

February 8, 2005 January 2007 July 2008 December 2008 March 2011

Medical Advisory Council Update with no revisions to the policy Removed HCPC's code Z5093 from policy Removed reference as DME from policy statement Added Medicare criteria Update. Added Medicare Table with link to NCD. No Revisions.

This policy is based on the following evidence-based guidelines:

1. Hirsh J, MD, Dalen JE, Anderson DR, et al. Oral Anticoagulants: Mechanism of Action, Clinical Effectiveness, and Optimal Therapeutic Range. Chest. 2001;119:8S-21S. Accessed at: http://www.chestjournal.org/cgi/content/full/119/1_suppl/8S 2. Ansell, J, Hirsh J, Dalen, J, et al. Managing Oral Anticoagulant Therapy. Chest. 2001;119:22S-38S. Accessed at: http://www.chestjournal.org/cgi/content/full/119/1_suppl/22S 3. Hyers TM, Agnelli G, Hull RD, et al. Antithrombotic Therapy for Venous Thromboembolic Disease. Chest. 2001;119:176S-193S. Accessed at: http://www.chestjournal.org/cgi/content/full/119/1_suppl/176S 4. Albers GW, Dalen JE, Laupacis A, et al. Antithrombotic Therapy in Atrial Fibrillation. Chest. 2001;119:194S-206S. Accessed at: http://www.chestjournal.org/cgi/content/full/119/1_suppl/194S 5. Salem DN, Daudelin DH, Levine HJ, et al. Antithrombotic Therapy in Valvular Heart Disease. Chest. 2001;119:207S-219S. Accessed at: http://www.chestjournal.org/cgi/content/full/119/1_suppl/207S 6. Stein PD, Alpert JS, Bussey HI, et al. Antithrombotic Therapy in Patients With Mechanical and Biological Prosthetic Heart Valves. Chest. 2001;119:220S-227S. Accessed at: http://www.chestjournal.org/cgi/content/full/119/1_suppl/220S 7. Hayes. Medical Technology Directory. Self-Monitoring and Self-Management of Oral Anticoagulant Therapy. 2006, updated 2010. Available at: https://www.hayesinc.com/subscribers/displaySubscriberArticle.do?articleId=232 7&searchStore=%24search_type%3Dall%24icd%3D%24keywords%3DHome%2 CProthrombin%2CINR%2CMonitoring%24status%3Dall%24page%3D1%24from_ date%3D%24to_date%3D%24report_type_options%3D%24technology_type_opt ions%3D%24organ_system_options%3D%24specialty_options%3D%24order%3 DasearchRelevance&sectionSelector=indexView

1. American Heart Association/American College of Cardiology (AHA/ACC) Scientific Statement. Guide to Warfarin Therapy. Circulation 2003;107:1692. Accessed at: http://circ.ahajournals.org/cgi/content/full/107/12/1692 2. Fitzmaurice DA, Machin SJ. Recommendations for patients undertaking self management of oral anticoagulation. BMJ 2001;323:985-989. Accessed at: http://bmj.bmjjournals.com/cgi/content/full/323/7319/985 3. Ansell JE, Weitz JI, Comerota AJ. Advances in Therapy and the Management of Antithrombotic Drugs for Venous Thromboembolism. Hematology 2000. Accessed at: http://www.asheducationbook.org/cgi/content/full/2000/1/266

Patient Education Websites

References Update ­ March 2011

1.

Matchar DB, Jacobson A, Dolor R, et al. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20.

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Posted: March 2011 2. 3. Ryan F, O'Shea S, Byrne S. The reliability of point-of-care prothrombin time testing. A comparison of CoaguChek S and XS INR measurements with hospital laboratory monitoring. Int J Lab Hematol. 2010 Feb;32(1 Pt 1):e26-33 Garcia-Alamino JM, Ward AM, Alonso-Coello P, et al. Self-monitoring and selfmanagement of oral anticoagulation. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD003839.

References Update - November 2008

1. NCD for Home Prothrombin Time INR Monitoring for Anticoagulation Management (190.11) Accessed November 2008 at http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=190.11&ncd_version=2&bask et=ncd%3A190%2E11%3A2%3AHome+Prothrombin+Time+INR+Monitoring+for +Anticoagulation+Management and http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6138.pdf

References Initial

1.

Nutescu EA. Point of care monitors for oral anticoagulant therapy. Semin Thromb Hemost. 2004 Dec;30(6):697-702. 2. Yang DT, Robetorye RS, Rodgers GM. Home prothrombin time monitoring: a literature analysis. Am J Hematol. 2004 Oct;77(2):177-86. 3. CMS Decision Memorandum: Home prothrombin time (INR) monitor for anticoagulation management. Accessed at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=209 and http://cms.hhs.gov/mcd/viewdecisionmemo.asp?id=72 4. Koertke H, Minami K, Boethig D, Breymann Th, Seifert D, Wagner N, Atmacha N, Krian A, Ennker J, Taborski U, Klovekorn WE, Moodorf R, Saggau W. INR self-management permits lower anticoagulation levels after mechanical heart valve replacement. Circulation. 2003;108:11-75. 5. McCahon D, Fitzmaurice A, Murray E, Fuller C, Hobbs R, Allan T, Raftery J. SMART: self-management anticoagulation a randomized trial. BMC Family Practice. 2003;4:11-30. 6. Finkelstein J, Khare R, Ansell J. Feasibility and patients' acceptance of Home Automated Telemanagement of oral anticoagulation therapy. AMIA Annu Symp Proc. 2003;:230-4. 7. Eldor A, Schwartz J. Self-management of oral anticoagulants with a whole blood prothrombin-time monitor in elderly patients with atrial fibrillation. Pathophysiol Haemost Thromb 2002;32(3):99-106. 8. Tay MH, Tien SL, Chua TS, et al. An evaluation of point-of-care instrument for monitoring anticoagulation level in adult cardiac patients. Singapore Med J. 2002 Nov;43(11):557-62. 9. Oral Anticoagulation Monitoring Study Group. Prothrombin measurement using a patient self-testing system. Oral Anticoagulation Monitoring Study Group. Am J Clin Pathol. 2001 Feb;115(2):280-7. 10. Andrew, Maureen, et al. Point-of-care prothrombin time measurement for professional and patient self-testing use, American Journal of Clinical Pathology, 2001; 115: 228-296. 11. Körtke, H., et al. INR self-management after mechanical heart valve replacement: ESCAT (early self-controlled anticoagulation trial), Z Kardiol, January 2001; 90 Suppl 6: 118-24. 12. Ansell J, Hirsh J, Dalin J, Bussey H, Anderson D, Poller L, Jacobson a, Deykin D, Matchar D. Managing oral anticoagulant therapy. Chest. 2001;119:225-388.

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Posted: March 2011 13. Macik B, Rand J, Konkle B. Thrombophilia: What's a practioner to do? Hematology 2001;(1):322-350. 14. Beyth RJ, Quinn L, Landefeld CS. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomized controlled trial. Ann Intern Med 2000;133(9):687-95 15. Koertke H, Minami K, Bairaktaris A et al. INR self-management following mechanical heart valve replacement. J Thromb Thrombolysis 2000;9(suppl1):S41-5 16. Pierce, Machelle T., et al. Point-of-care versus laboratory measurement of the international normalized ratio, Am J Health-Syst Pharm, 2000; 57: 2271-4. Accessed at: http://bms.brown.edu/curriculum/b108/valves/Lowdown/lowdown1.htm. 17. Cromheecke M, Levi M, Colly L, et al. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomized cross-over comparison. Lancet. 2000;356(9224):97-102. 18. Zimmerman CR. The role of point-of-care anticoagulation monitoring in arterial and venous thromboembolic disorders. Journal of Thrombosis and Thrombolysis 2000; 9:187-198. 19. Christensen TD, Attermann J, Pilegaard HK, et al. Self-management of oral anticoagulant therapy for mechanical heart valve patients. Scandinavian Cardiovascular Journal 2000;J35: 20. Cosmi B, Palareti G, Moia M, et al. Accuracy of a portable prothrombin time monitor (Coagucheck) in patients on chronic oral anticoagulant therapy: a prospective multicenter study. Thromb Res. 2000 Nov 15;100(4):279-86. 21. Cosmi B, Palareti G, Carpanedo M, et al. Assessment of patient capability to selfadjust oral anticoagulant dose: a multicenter study on home use of portable prothrombin time monitor (COAGUCHECK). Haematologica. 2000 Aug;85(8):826-31. 22. Marzinotto V, Monagle P, Chan A, et al. Capillary whole blood monitoring of oral anticoagulants in children in outpatient clinics and the home setting. Pediatr Cardiol. 2000 Jul-Aug;21(4):347-52. 23. Cosmi B, Palareti G, Moia M, et al. Home use of an ambulatory monitor for the determination of prothrombin time (coaguchek) in patients treated with oral anticoagulants. Multicenter prospective study. Minerva Cardioangiol. 1999 Dec;47(12):598-9. 24. Morsdorf S, Erdlenbruch W, Taborski U. Training of patients for selfmanagement or oral anticoagulation therapy; Standards, patient suitability, and clinical aspects. Semin Throb Hemostas. 1999;25(1):109-115. 25. Paxton A. Home-use PT devices a blessing for some. CAP Today. 1999;13:64, 62,64. 26. Sawicki P. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. JAMA. 1999;281(2):145-150. 27. Biasiolo A, Rampazzo P, Furnari O, Filippi B, Pengo V. Comparison between routine laboratory prothrombin time measurements and fingerstick determinations using a near-patient testing device (Pro-Time®). Thrombosis Research. 2000; 97: 495-498. 28. A new approach to monitoring anticoagulation therapy: testing prothrombin time at home. Harvard Heart Letter. 1999; 9 (5): 2-4. 29. Douketis, James D., et al. Accuracy of a portable international normalization ratio monitor in outpatients receiving long-term oral anticoagulant therapy: Comparison with a laboratory reference standard using clinically relevant criteria for agreement, Thrombosis Research 1998;92:11-17.

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Posted: March 2011 30. Hirsh J, Dalen J, Anderson D, Pollar L, Bussey H, Ansell J, Deykin D, Brandt J. Oral Anticoagulants Mechanism of Action, Clinical Effectiveness, and Optimal Therapeutic Range. CHEST. 1998;114:445S-469S. 31. Titus K. PT self-test devices approved, but some are wary. CAP Today. 1997 July; 11(7): 5-10. 32. Leaning KE, Ansell JE. Advances in the Monitoring of Oral Anticoagulation: Pointof-Care Testing, Patient Self-Monitoring, and Patient Self-Management. J Thromb Thrombolysis. 1996;3(4):377-383. 33. Bussey H, Force R, Bianco T. Reliance on prothrombin time ratios causes significant errors in anticoagulation therapy. Arch Intern Med. 1992; 152:278282. 34. Hanuschka P, Lian J. Ostreocalcin and matrix Gla protein: vitamin K-dependent proteins in bone. Physiol Rev. 1989;69:990-1047. 35. Lucas F, Duncan A, Jay R, Coleman R, Craft P, Winfrey L, Mungall D, Hirsh J. A novel whole blood capillary technic for measuring the prothrombin time. Am J Clin Pathol. 1987;88(4):442-6. 36. White R, McCurdy SA von Marensdorff H, Woodruff D, Leftgoff L. Home prothrombin time monitoring after initiation of warfarin therapy. Ann Intern Med. 1989;111:730-737.

Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net's National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member's benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, new or revised policies require prior notice or posting on the website before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, new or revised policies require prior notice or website posting before an amendment is deemed effective. No Medical Advice.

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Posted: March 2011

The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member's Contract Controls Coverage Determinations. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member's contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member's contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member's contract shall govern. Coverage decisions are the result of the terms and conditions of the Member's benefit contract. The Policies do not replace or amend the Member's contract. If there is a discrepancy between the Policies and the Member's contract, the Member's contract shall govern. Policy Limitation: Legal and Regulatory Mandates and Requirements. The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Policy Limitations: Medicare and Medicaid. Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.

Disclaimer This article was prepared as a service to the public and is not intended to grant rights or impose obligations. This article may contain references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or regulations. We encourage readers to review the specific statutes, regulations and other interpretive materials for a full and accurate statement of their contents. CPT only copyright 2007 American Medical Association.

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