Home Prothrombin Time Monitors
Durable Medical Equipment
© Blue Cross and Blue Shield of Montana
Current Effective Date:
July 18, 2013
Original Effective Date:
November 07, 2008
April 18, 2013
March 1, 2010, June 1, 2011; June 27, 2012; April 17, 2013
Warfarin is an effective anticoagulant for the treatment and prevention of venous and arterial thrombosis. Chronic warfarin therapy is recommended in all patients with mechanical heart valves and in some patients with chronic atrial fibrillation (i.e., patients with one high-risk factor or more than one moderate-risk factor). Patients with mechanical heart valves are frequently anticoagulated at higher levels than for other indications, which puts them at higher risk of complications from warfarin therapy. Appropriate levels of warfarin anticoagulation are monitored with periodic prothrombin time measurements, as measured by the International Normalized Ratio (INR). For example, an INR >3 results in a higher risk of serious hemorrhage, while an INR of six increases the risk of developing a serious bleed nearly seven times that of someone with INR less than three. In contrast, an INR below two is associated with increased risk of stroke. Therefore, monitoring of the prothrombin times is recommended to ensure that the dose levels are within the therapeutic range.
There are at least three sites of monitoring anticoagulation:
- Physician's office (80%): usually once a month;
- Anticoagulation clinics (20%): usually once every 2-3 weeks; or
- Home: prothrombin time monitors (<5%).
There are several different devices approved by the U. S. Food and Drug Administration (FDA) that may be purchased by the patient for in-home monitoring of chronic anti-coagulant therapy. 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 measures. However, the clinical impact of home prothrombin time monitoring is related to improved warfarin management. Specifically, home prothrombin time monitoring permits more frequent monitoring and self-management of warfarin therapy with the ultimate goal of:
- Increasing the time that the anticoagulation is within a therapeutic INR range (intermediate health outcome); and
- Decreasing the incidence of thromboembolic or hemorrhagic events (final health outcome).
Home self-monitoring is typically associated with some form of self-management of warfarin therapy. In some cases, the patient may be supplied with treatment algorithms and instructed to alter the dose based on the results of self-monitoring. In other cases, the patient may be instructed to telephone in the results of the self-monitoring and receive further telephonic instructions on warfarin dose.
BCBSMT may consider prothrombin time (PT) home monitoring devices medically necessary when used as an adjunct to regulation of anti-coagulant therapy in high-risk members that includes:
- Patients with mechanical heart valves who have been stable on anticoagulation management for at least three months; OR
- Patients with chronic atrial fibrillation or pulmonary embolism on warfarin; OR
- Patients with venous thromboembolism, inclusive of deep venous thrombosis; OR
- Patients with a hypercoagulable state, including but not limited to:
- Antithrombin III deficiency,
- Protein C deficiency,
- Protein S deficiency,
- Activated Protein C resistance (Factor V Leiden),
- Antiphospholipid syndrome,
- Prothrombin 20210 defect,
- Dysfibrinolysis, AND
In addition to the above indications, the patient must:
- Have an anticipated length of need of greater than six months; and
- Have been anticoagulated for at least three months prior to use of the home International Normalized Ratio INR device; and,
- 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; and,
- Continue to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring; and,
- Perform self-testing with the device not to occur more frequently than once a week.
BCBSMT considers prothrombin time (PT) home monitoring devices not medically necessary if the above criteria are not met.
286.3, 289.81, 415.1, 415.11, 415.12, 415.19, 416.2, 427.31, 453.40, 453.41, 453.42, 453.50, 453.51, 453.52, V43.3, V58.61
99363, 99364, G0248, G0249, G0250
- Centers for Medicare and Medicaid Services (CMS) Decision Memorandum: Home prothrombin time (INR) monitor for anticoagulation management. Available at www.cms.gov .
- Beyth, R.J., Quinn, L., et al. A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin. A randomized controlled trial. Annals of Internal Medicine (2000) 133(9):687-95.
- Koertke, H., Minami, K., et al. INR self-management following mechanical heart valve replacement. Journal of Thrombosis and Thrombolysis (2000) 9 (supplement1) S41-5.
- Eldor, A., and J. Schwartz. Self-management of oral anticoagulants with a whole blood prothrombin-time monitor in elderly patients with atrial fibrillation. Pathophysiology Haemostasis Thrombosis (2002) 32(3):99-106.
- Yang, D.T., Robetorye, R.S., et al. Home prothrombin time monitoring: a literature analysis.
- American Journal of Hematology (2004 Oct.) 77(2): 177-86.
- Fitzmaurice, D.A., Murray, E.T., et al. Self management of oral anticoagulation: randomised trial. British Medical Journal (2005) 331(7524):1057.
- Menendez-Jandula, B., Souto, J.C., et al. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Annals of Internal Medicine (2005) 142(1):1-10
- Prothrombin Time (PT/INR) Monitoring for Home Anticoagulation Management. Centers for Medicare & Medicaid Services (CMS) Change Request 6138. Pub 100-03 Medicare National Coverage Determinations Transmittal 90 (2008 July 25).
- Ansell, J., Hirsh, J., et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest (2008)133(6 Suppl):160S-198S.
- Gardiner, C., Longair, I., et al. Self-monitoring of oral anticoagulation: does it work outside trial conditions? J Clin Pathol (2009) 62(2):168-71.
- Home Prothrombin Time Monitoring. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2010 Mar.) Durable Medical Equipment 1.01.14.
||Updated rationale and references|
||Policy updated with literature search; reference numbers 2, 3, 8-10 added; other references renumbered/removed; no change in policy statement|
Title changed from "Home Prothrombin Time INR Monitoring for Anticoagulation Management" to "Home Prothrombin Time Monitors". Additional criteria added to the Medically Necessary statement. Rationale and formatting revised.