Home Prothrombin Time Monitor for Anticoagulation Management
DESCRIPTION
Warfarin (Coumadin) is an anticoagulant for the treatment and prevention of venous and arterial thrombosis. Appropriate levels of warfarin anticoagulation are monitored with periodic prothrombin time measurements, as measured by the International Normalized Ratio (INR). Monitoring of the prothrombin time is recommended to ensure that the dose levels are within the therapeutic range. Prothrombin time is measured by a method known as the International Normalized Ratio (INR). The INR reflects the ratio of the individual's prothrombin time to the normal time. This is used to determine the effect of warfarin and to regulate its dosage.
Examples of different devices approved by the FDA that may be purchased by the individual for in-home monitoring of chronic anticoagulant therapy are CoaguChek®, ProTime®, Avocet® and Rubicon®.
POLICY
Home prothrombin time monitoring for anticoagulation management is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Home prothrombin time monitoring for anticoagulation management of other conditions / diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Home prothrombin time monitoring when used for anticoagulation monitoring is considered medically appropriate if ALL the following criteria are met:
ANY ONE of the following conditions:
History of strokes
Chronic or recurrent atrial fibrillation
Mechanical heart valve implants
Children with congenital heart disease
Other conditions requiring consistent warfarin therapy for six months or longer
ANY ONE of the following criteria:
Homebound due to medical reasons for the duration of treatment
ALL of the following criteria:
Place of residence is located more than 30 miles or 30 minutes travel time one way from network facility or office capable of providing the service
Duration of warfarin treatment is expected for six months or longer
Prothrombin time monitoring is required weekly, bi-weekly or more often
Documentation that the individual or caregiver has been trained and is capable of performing the test accurately
ADDITIONAL INFORMATION
No randomized controlled studies were found in the published literature to evaluate the clinical importance of home prothrombin time monitoring for other conditions or diseases.
SOURCES
American Academy of Family Physicians. (2005). A systematic approach to managing warfarin doses. Retrieved September 16 2009 from http://www.aafp.org/fpm/20050500/77asys.html.
American Heart Association/American College of Cardiology Foundation. AHA/ACC Scientific Statement. (2003). Guide to warfarin therapy. Retrieved September 16, 2009 from http://circ.ahajournals.org/cgi/content/full/107/12/1692.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2009). Home prothrombin time monitoring (1.01.14). Retrieved September 15, 2009 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, July). Home prothrombin time international normalized ratio (INR) monitoring for anticoagulation management. (NCD 190.11, p. 2-89). The Ingenix Complete Guide to Medicare Coverage Issues.
ECRI Institute. Health Technology Assessment Information Service. Evidence Reports.(2008, December). Portable devices for home monitoring of oral anticoagulation therapy. Retrieved September 16, 2009 from ECRI Institute. (20 articles and/or guidelines reviewed)
Eldor, A., & Schwartz, J. (2002). Self-management of oral anticoagulants with a whole blood prothrombin-time monitor in elderly patients with atrial fibrillation. Pathophysiology of Haemostasis and Thrombosis, 39, 99-106.
Green, D., Ansell, J. & Moll, S. (2008). International normalized range monitoring for anticoagulated patients at home. US Cardiology, 5 (1), 22-25.
Hayes. Medical Technology Directory. (2008, November). Self-monitoring and self-management of oral anticoagulant therapy. Retrieved September 16, 2009 from www.Hayesinc.com/subscribers. (94 articles and/or guidelines reviewed)
Health Technology Assessment. (2007) Clinical effectiveness and cost effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling. Retrieved September 16, 2009 from http://www.hta.ac.uk/pdfexecs/summ1138.pdf .
Hill, J., Perreault, S., & Dorval, M. Validity of Coagucheck S for home monitoring of anticoagulant therapy in pediatrics. Canadian Journal of Cardiology, 23 (1), 47-50.
Jones, B. A., & Meier, F. A. (2004). Patient safety in point-of-care testing. Clinics in Laboratory Medicine, 24, 997-1022.
McCahon, D., Fitzmaurice, D. A., Murray, E. T., Fuller, C. J., Hobbs, R. F., Allan, T. F., et al. (2003). SMART: Self-management of anticoagulation, a randomized trial. BMC Family Practice, 4, 11.
Poller, L., Keown, M., Ibrahim, S.A., van der Meer, F.J., van den Besselaar, A.M., Tripodi, A., et al. (2006). Quality assessment of CoaguCheck point-of-care prothrombin time monitors: comparison of the European community- approved procedure and conventional external quality assessment. Clinical Chemistry, 52 (10), 1843-1847.
ORIGINAL EFFECTIVE DATE: 3/1998
MOST RECENT REVIEW DATE: 11/12/2009
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.