Clinical UM Guideline
|Subject:||Prothrombin Time Self-Monitoring Devices|
|Guideline #:||CG-DME-30||Current Effective Date:||04/05/2016|
|Status:||Reviewed||Last Review Date:||02/04/2016|
This document addresses the clinical indications for use of battery-operated prothrombin time self-monitoring devices, also referred to as International Normalized Ratio (INR) devices, used by individuals in the home to monitor blood-clotting rates.
Home prothrombin time self-monitoring using an INR device is considered medically necessary for an individual who meets all of the following criteria:
Not Medically Necessary:
Home prothrombin time self-monitoring is considered not medically necessary for an individual who does not meet the above criteria.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
|G0248||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 test results, and documentation of patient's ability to perform testing and report results|
|G0249||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 4 tests|
|G0250||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 4 tests|
|No specific code for INR monitor device|
Home prothrombin time self-monitoring permits frequent measurement and self-management of anticoagulant therapy (for example, warfarin) with the ultimate goal of increasing the time that anticoagulation is within a therapeutic INR range while decreasing the risk of thromboembolic or hemorrhagic events. The most common indications for chronic oral anticoagulation therapy include individuals with mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism (inclusive of deep venous thrombosis and pulmonary embolism).
A prothrombin time self-monitoring system is a battery-operated device used to monitor blood-clotting rates by an individual in the home setting. Each of these systems includes a monitor, a disposable plastic reagent cartridge and a finger stick blood collection kit. The device stores between 30-40 of the most recent test results, which are date and time-stamped. This enables the physician, individual, or caregiver the ability to review the results and monitor trends in the individual's oral anticoagulant therapy control. After testing, the individual either notifies the physician of the results or uses an individualized algorithm, developed with physician supervision, to adjust the anticoagulation dosage (warfarin sodium/Coumadin®, Bristol-Myers Squibb, Princeton, NJ) to maintain prothrombin time levels within a target zone. The goal of self-monitoring and self-management of prothrombin time levels is to improve anticoagulation control and reduce the risk of adverse events. Several U.S. Food and Drug Administration (FDA) approved prothrombin time self-monitoring devices are available for use in the home including, but not limited to: CoaguSense™ Self-Test PT/INR Monitoring System (CoaguSense, Inc., Fremont, CA), ProTime® Microcoagulation System (International Technidyne Corporation [Accriva Diagnostics], South Piscataway, NJ), CoaguChek® XS System for Patient Self-Testing (PST) (Roche Diagnostics-North America, Indianapolis, IN), CoagCare® (ZyCare® Inc, Chapel Hill, NC), and Alere™ INRatio®/INRatio® 2 PT/INR Monitoring Systems (Alere Inc., Waltham, MA). Home prothrombin time self-monitoring devices require a prescription for use. The prescribing physician is responsible for the training and ongoing management of individuals selected for self-monitoring.
Oral anticoagulant drugs have been used in the prophylaxis and treatment of venous thrombosis, pulmonary embolus, thromboembolic complications of atrial fibrillation, prosthetic heart valve replacement, and to reduce the risk of recurrent myocardial infarctions and transient ischemic attacks. In the United States, coumarin derivatives are the most commonly used oral anticoagulants and include warfarin sodium (Coumadin) and dicumarol. All oral anticoagulants have a narrow therapeutic index. Changes in diet, drug interactions, illness, individual differences, and spontaneous fluctuations in the sensitivity to oral anticoagulant influence the dose-response relationships for these drugs. As a result, oral anticoagulant therapy requires individualized treatment for each person and frequent blood coagulation monitoring to prevent serious bleeding from too much anticoagulation or thromboembolic complications from inadequate coagulation.
In general, the anticoagulant effect of warfarin is optimized at an INR of about 2.5 (desirable range, 2.0-3.0), although a higher level may be better in certain clinical conditions such as in individuals with prosthetic heart valves. The risk of bleeding increases with an increasing INR and becomes clinically unacceptable when the INR exceeds 5.0. Major bleeding has been reported in 1.1%-8.1% of individuals during each year of long-term warfarin therapy. Risk factors include advanced age, serious illness (for example, cerebral, cardiac, kidney or liver disease), cerebrovascular or peripheral vascular disease, and an unstable anticoagulant effect.
The studies reviewed evaluate individuals with a variety of indications for anticoagulation therapy. The majority of individuals received anticoagulation therapy for prosthetic heart valve replacement. Studies also included individuals with deep venous thrombosis, atrial fibrillation, total hip arthroplasty, and history of pulmonary emboli. Controlled studies show prothrombin time self-monitoring devices are effective in maintaining the INR values within a therapeutic range. None of the studies indicate a decrease in anticoagulation control. Improvement is thought to be due to several factors. Prothrombin time testing intervals in the self-monitored individual are performed weekly as compared to every 2 weeks to monthly intervals when performed by a physician. The complications associated with self-monitoring appear to be equivalent to or less than those associated with anticoagulation therapy monitored by a physician or a specialized clinic. When individuals are given proper training and support, the cumulative evidence from clinical trials suggests that prothrombin time self-monitoring with a home testing device is accurate, feasible, and possibly more effective than standard laboratory prothrombin time testing in maintaining anticoagulation control within target therapeutic ranges. In the studies evaluated, the results obtained with prothrombin time self-monitoring do not appear to vary with the individual's diagnosis.
The FDA approval of home prothrombin time self-monitoring devices is based on the demonstration that home prothrombin monitors produce results similar to laboratory-based measurements. The FDA approval did not require clinical data demonstrating that the increased frequency of home self-monitoring would improve health outcomes. Several randomized studies have reported improved health outcomes (primarily increased time in the therapeutic range) associated with home self-monitoring and management compared to monitoring either in a physician's office or in a specialty anticoagulation clinic. A Cochrane meta-analysis (Garcia-Alamino, 2010) reported on a pooled estimate of 18 randomized controlled trial (4723 participants), showing significant reductions in both thromboembolic events (risk ratio [RR], 0.50; 95% confidence interval [CI], 0.36 to 0.69) and all-cause mortality (RR, 0.64; 95% CI, 0.46 to 0.89). Trials of self-management alone showed significant reductions in thromboembolic events (RR, 0.47; 95% CI, 0.31 to 0.70) and all-cause mortality (RR, 0.55; 95% CI, 0.36 to 0.84); self-monitoring did not (thrombotic events RR, 0.57; 95% CI, 0.32 to 1.00; mortality RR, 0.84; 95% CI, 0.50 to 1.41). Self-monitoring significantly reduced major hemorrhages (RR, 0.56; 95% CI, 0.35 to 0.91) while self-management did not (RR, 1.12; 95% CI, 0.78 to 1.61). A total of 12 trials reported improvements in the percentage of mean INR measurements in the therapeutic range. No heterogeneity was identified in any of these comparisons. The authors concluded that compared to standard monitoring, individuals who self-monitor or self-manage improve the quality of their oral anticoagulation therapy. The number of thromboembolic events and mortality were decreased without increases in harms. However, self-monitoring or self-management were not feasible for up to half of the individuals requiring anticoagulant therapy due to refusal to participate, exclusion by their general practitioner, and inability to complete training.
Bloomfield and colleagues (2011) published a meta-analysis and systematic review that included randomized controlled trials with adult subjects comparing home monitoring to monitoring in a physician's office or anticoagulation clinic; studies included adults receiving long-term (>3 months) therapy. The systematic reviews identified 22 trials; 5 on self-monitoring only and 14 that included self-management. In a pooled analysis, there were significantly fewer major thromboembolic events in the self-monitoring and self-management group (99 of 4004 subjects, 2.5%) compared to the standard treatment group (149 of 3755 subjects, 4.0%; odds ratio [OR], 0.58; 95% CI, 0.45 to 0.75). Rates of major bleeding events did not differ significantly in the 2 groups. Similar to the Cochrane meta-analysis (Garcia-Alamino, 2010), the authors noted the low rate of study participation in subjects who met preliminary eligibility criteria. The authors did not conduct separate analysis of studies that did and did not enroll inception cohorts.
Heneghan and colleagues (2012) published a meta-analysis using a design similar to the other published meta-analyses. The investigators searched for randomized controlled trials comparing self-monitoring or self-management of oral anticoagulation by adults compared to management by a physician or anticoagulation clinic. This review did not discuss the issue of whether or not home monitoring occurred in the initial 3 months of anticoagulation therapy. The meta-analysis included data on 6417 participants from 11 of the eligible 21 trials. In a pooled analysis, there was a statistically significant reduction in thromboembolic events in the home prothrombin time when the protime monitoring group was compared to the standard therapy group (hazard ratio [HR], 0.51; 95% CI, 0.31 to 0.85). There was not a significant difference between groups in the rate of major hemorrhagic events (HR, 0.88; 95% CI, 0.74 to 1.06) or death (HR, 0.82; 95% CI, 0.62 to 1.09).
Effective March 19, 2008, the Centers for Medicare and Medicaid Services (CMS) implemented a National Coverage Determination (NCD) for Home Prothrombin Time Monitoring for Anticoagulation Management. Coverage indications include "the use of home PT/INR monitoring for chronic, oral anticoagulation management for patients with mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism (inclusive of deep venous thrombosis and pulmonary embolism) on warfarin" (CMS, 2008). The coverage determination includes specific participant selection criteria and monitoring by the prescribing physician.
On December 4, 2014, the FDA issued a Medical Device Safety and Recall for the Alere INRatio and INRatio 2 PT/INR Monitor Systems manufactured and distributed from April 1, 2008 to December 4, 2014. The recall states:
The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) may provide an INR result that is lower than expected result obtained using a laboratory INR method. Incorrect results can also occur if a patient has certain medical conditions. These conditions include, anemia, conditions associated with elevated fibrinogen levels, or unusual bleeding or bruising. Incorrect results can also occur if the instructions in the labeling for performing the test are not followed…Use of the affected devices may delay treatment and cause severe or life-threatening injuries, including death. Alere received a total of 18,924 complaints of all types for the INRatio Test Strip (Optimize) from 2013-2014.
Additional recall information for individual users and healthcare professionals is available at: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm429496.htm.
International Normalized Ratio (INR): A standardized system established by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis (ICTH) for reporting the results of blood coagulation (clotting) tests using the international sensitivity index for the particular thromboplastin reagent and instrument combination utilized to perform the test.
Prothrombin time (PT): A test belonging to a group of blood tests that assess the clotting ability of blood; also known as the protime or PT test.
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
Alere INRatio/INRatio2 PT/INR Monitoring Systems
CoagCare Anticoagulation Management System
CoaguChek XS System
Coagu-Sense Self-Test PT/INR Monitoring System
ProTime Microcoagulation System
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Reviewed||02/04/2016||Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion and References sections. Removed ICD-9 codes from Coding section.|
|Reviewed||02/05/2015||MPTAC review. Minor format change to Note in the Clinical Indications section. Updated Description, Discussion, and References sections.|
|Reviewed||02/13/2014||MPTAC review. Updated Discussion. Minor format changes throughout sections.|
|Reviewed||02/14/2013||MPTAC review. Updated Discussion, References, and Index.|
|Reviewed||02/16/2012||MPTAC review. Removed cross-reference to Attachment A including the Medical Review Sheet/form. Updated Description, Discussion, References, Coding and Index.|
|Reviewed||02/17/2011||MPTAC review. Updated Discussion/General Information, References, Index and Attachment A.|
|Reviewed||02/25/2010||MPTAC review. Clarified Clinical Indications. Updated References.|
|10/01/2009||Updated Coding section with 10/01/2009 ICD-9 changes.|
|Reviewed||02/26/2009||MPTAC review. Updated Description, Discussion, References and Index.|
|Reviewed||02/21/2008||MPTAC review. Updated Description, Definitions, References and Index.|
|Reviewed||07/02/2007||Updated FDA-approved devices in Description, Index, and Attachment A. Clarified medical review guidance statement in Attachment A.|
|New||03/08/2007||MPTAC review. Initial document development. Transferred content from DME.00001 Prothrombin Time Self-Monitoring Devices. References updated.|