ARCHIVED

Medical Policy

Policy Num:    01.001.017
Policy Name:  Home Prothrombin Time Monitoring
Policy ID        [01.001.017]  [Ar / L / M+ / P+]  [1.01.14]

Last Review:    November 30, 2023
Next Review:   Policy Archived

ARCHIVED
 

Related Policies:

11.003.067 Genotype-Guided Warfarin Dosing

Home Prothrombin Time Monitoring

Summary

Patients who are prescribed chronic warfarin anticoagulation need ongoing monitoring that has generally taken place in a physician’s office or anticoagulation clinic. Home prothrombin monitoring with a U.S. Food and Drug Administration (FDA)‒approved device is proposed as an alternative to office or laboratory-based testing. 

Summary of Evidence

Data from multiple randomized controlled trials (RCTs) consistently demonstrate that the use of self monitoring in patients who are initially managed in a clinical setting results in an increased time in the therapeutic range. Based on prior research, it is likely that time in therapeutic International Normalized Ratio (INR) is associated with improved health outcomes. Some studies also report a lower rate of hemorrhagic or embolic events, but this evidence is limited by high dropout and noncompliance rates that may have created imbalances between treatment groups. The evidence includes monitoring in several chronic conditions such as mechanical heart valves, chronic atrial fibrillation, and deep venous thrombosis, and therefore comparable results should be able to be obtained in other similar, but less prevalent, conditions that require continuous anticoagulation. Thus, based on the evidence and clinical context, home prothrombin time monitoring may be considered medically necessary for patients with chronic conditions that require continuous oral anticoagulation with warfarin who are able to self-monitor and who have undergone initial clinic-based anticoagulation management for at least 3 months.

The evidence is insufficient to conclude that the use of initial self-monitoring improves the net health outcome. RCTs with sufficient large samples that report health outcomes are needed to more thoroughly evaluate the safety and efficacy of home prothrombin time monitoring from the start of treatment. Therefore, the use of home monitoring during the initial treatment period is considered investigational.

Objective

The objective of this evidence review is to evaluate whether the use prothrombin time (INR) home testing devices improves the net health outcome in individuals with conditions requiring warfarin treatment.

Policy Statement

At-home monitoring of chronic warfarin therapy may be considered medically necessary in patients who require continuous anticoagulation use for long term (>6 months) or life - long coagulation for any of the following chronic medical conditions:

• Mechanical heart valves
• Chronic atrial fibrillation
• Venous thromboembolism inclusive of deep vein thrombosis (DVT) and pulmonary embolism
• Ventricular Assist Devices (VAD)
• Hypercoagulable states

All the following criteria must be met for home PT/INR Monitoring: 

• The device must be Food and Drug Administration - approved
• The patient must have been anticoagulated for at least 3 months prior to use of the home INR device;and, 
• 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; and,
• The patient continues to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring; and, 
• The expected need for home INR testing is 6 or more months;
• Self-testing with the device should not occur more frequently than once a week.

The use of home monitoring during the initial treatment period is considered investigational.

Testing more frequently than once per week is generally considered investigational. 

Policy Guidelines

In 2003, 3 HCPCS codes were introduced that specifically apply to home monitoring of prothrombin: G0248, G0249, and G0250 (see Codes section below.) Typically, a 1-month to 6-week supply of test strips is requested, which can vary from 25 test strips to only 6 test strips if the patient only self-monitors once a week.

Benefit Application

BlueCard/National Account Issues

In 2001, the Centers for Medicare and Medicare Services issued a national Medicare coverage policy recommending coverage for home monitoring of prothrombin time for patients with mechanical heart valves. Plans may want to consider individual consideration for the purchase of the home monitoring device and supplies. 

Home monitoring (self-management) has not been shown to be superior to standard monitoring (physician office or anticoagulation clinics) for patients with chronic, atrial fibrillation (AF) or deep venous thrombosis. Therefore, benefit or contract language describing the “least costly alternative” may be applicable.

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

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 AF (ie, patients with risk factors that indicate a higher likelihood of stroke). Patients with mechanical heart valves are frequently prescribed anticoagulants at higher levels than patients given anticoagulants 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 INR. The target INR range is 2.0 to 3.0 for most patients. An INR result greater than 3 indicates an increased risk of serious hemorrhage, while an INR less than 2 is associated with an increased risk of stroke. An INR of 6 indicates an increased risk of developing a serious bleed, nearly 7 times that of someone with an INR less than 3. Therefore, monitoring of the prothrombin time is recommended to ensure that the prescribed dosing regimens result in INRs within the therapeutic range. Anticoagulation can be monitored: in the physician's office (usually once a month), at an anticoagulation clinic (usually once every 2-3 weeks), or at home. 

For home prothrombin time monitoring to be effective, patients need to be appropriately trained and able to generate INR test results comparable with laboratory measures. Moreover, 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 (1) increasing the time that the anticoagulation is within a therapeutic INR range (intermediate health outcome); and (2) 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 provide the results of the self-monitoring (eg, on the telephone or internet) and receive instructions on warfarin dosage.

Different products have been approved by the FDA for the purpose of monitoring anticoagulation in cases of chronic therapy. The FDA approval of these devices is based on the fact that it has been demonstrated that if the patient is properly trained, they can generate INR results comparable to laboratory results. The clinical impact of home prothrombin time monitoring is related to improving warfarin treatment.

REGULATORY STATUS

In January 2007, the CoaguChek® XS System (patient self-testing) (Roche Diagnostics) was cleared for marketing by FDA through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices, including the CoaguChek SX System (professional, cleared in 2006). Other than a labeling change, the device is identical to the professional version of the CoaguChek XS System. The patient self-testing system is intended for self-monitoring of prothrombin time in patients who are on a stable regimen of anticoagulation medications.

Other devices cleared by FDA for home prothrombin time monitoring include the ProTime® Microcoagulation System (International Technidyne) and the Alere™ (formerly Hemosense) INRatio®2 PT/INR Monitoring System.

FDA has cleared 6 tests for prescriptive home use for prothrombin assays, only three are active at this point.

1. International Technidyne Corporation - ProTime Microcoagulation System, k010599
2. HemoSense - INRatio, k021923
3. Roche Diagnostic Corporation - CoaguChek XS and CoaguChek PST, k062925, k962571
4. LifeScan Inc.-Rubicon Prothrombin Time Monitoring System, k001699, k022922 ** No Active Listing
5. Avocet Medical, Inc. - Avocet AccuSure System, k991286 **No Active Listing
6. Boehringer Mannheim Corporation, K962571 **bought out by Roche Diagnostic

Since October 4, 2006, the FDA approved labeling for Coumadin® has included the following Black Boxed warning.

Rationale

This policy was originally created in 1997 and was updated regularly with searches of the MEDLINE database.  The most recent literature update was performed through November 2, 2023.

Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.”

The preferred study design to evaluate home prothrombin time (PT) monitoring is a randomized controlled trial (RCT) comparing home PT monitoring with either monitoring in a physician's office or monitoring in specialized coagulation clinics. As with any monitoring technology, one would ideally want to isolate the contribution of the monitored data itself from the possible impact of increased patient education or contact with health professionals that is typically associated with more intense monitoring. Final health outcomes would preferably focus on the incidence of hemorrhagic or embolic events. However, due to the low incidence of these events, published studies often report instead the intermediate outcome of time spent in the therapeutic range of warfarin, as measured by the international normalized ratio (INR). Prior research has established a strong link between time outside the therapeutic range and adverse events such as bleeding and thromboembolism. Therefore, time in the therapeutic range is a useful intermediate outcome for true health outcomes in this situation. 

Population Reference No. 1 

Home Monitoring During Maintenance Therapy

Most studies of home PT monitoring include patients who are already being treated with Coumadin, and therefore evaluate home monitoring in the setting of maintenance therapy. A 2010 Cochrane review evaluated the impact of self-monitoring and self-management of oral anticoagulation compared with standard monitoring.1 Self-monitoring referred to use of point-of-care testing and self-management, which additionally involved having patients interpret the results and adjust the dose of medication themselves. The authors identified 18 RCTs (total N=4723 participants). The review identified 6 trials on selfmonitoring, 11 trials on self-management, and 1 trial that reported both outcomes. (In reporting the findings, the term “home monitoring” will refer to self-monitoring or self-management). Three trials included only patients with mechanical heart valves (MHVs), 2 trials included patients with atrial fibrillation (AF), and 13 trials included patients with a mix of indications for oral anticoagulation. A pooled analysis of data from all 18 trials found that, compared with standard therapy, home monitoring reduced thromboembolic events by half (relative risk [RR], 0.50; 95% confidence interval [CI], 0.36 to 0.69). This difference was statistically significant (p<001). The intervention effect was larger in the self-management studies (pooled RR=0.47; 95% CI, 0.31 to 0.70; p<0.001) than in the self-monitoring studies (pooled RR=0.57; 95% CI, 0.32 to 1.00; p=0.05). A pooled analysis of data from 9 trials found a statistically significant reduction in mortality with home monitoring compared with standard therapy (pooled RR=0.64; 95% CI, 0.46 to 0.89; p=0.007). In terms of potential harms, a pooled analysis of data from 14 trials did not find a significant difference in the risk of major hemorrhage with standard therapy compared with home monitoring. The relative risk was 0.87 (95% CI, 0.66 to 1.16: p=0.34). Compared with standard therapy, however, there was a significantly reduced risk of minor hemorrhage with home monitoring. Pooling data from 14 trials, the relative risk was 0.64 (95% CI, 0.54 to 0.77; p<0.001). Although this study reported that self-monitoring and self-management resulted in better outcomes without increasing the risk of major hemorrhage, home monitoring was not feasible for up to half of patients requiring anticoagulant therapy due to patient refusal, doctor recommendation, or inability to complete training. 

A similar meta-analysis was published in 2011 by Bloomfield et al.2 The newer meta-analysis included a large RCT by Matcher et al (2010) (described in more detail next), which was not available at the time the Cochrane systematic review was conducted. Study inclusion criteria included RCTs with adult subjects that compared home monitoring with 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. Eight studies were limited to patients with MHVs, and the other 14 included patients with various indications. Three studies enrolled inception cohorts (patients who had started oral anticoagulation therapy in the previous 3 months), 8 studies did not enroll inception cohorts, and 8 studies were mixed or unclear about this inclusion criterion. (See later  section on home self-monitoring from the beginning of treatment.) In a pooled analysis, there were significantly fewer major thromboembolic events in the self-monitoring and self-management group (99/4004 patients [2.5%]) compared with the standard treatment group (149/3755 [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. There were 283 of 4061 (7.0%) events in the home-monitoring group and 300 of 3806 (7.9%) in the standard treatment group (OR=0.89; 95% CI, 0.75 to 1.05). Similar to the Cochrane review, the authors noted the low rate of study participation in patients who met preliminary eligibility criteria. The authors did not conduct separate analysis of studies that did and did not enroll inception cohorts.

A 2012 meta-analysis by Heneghan et al used individual patient data; otherwise, the design was similar to the other published meta-analyses.3 The investigators searched for RCTs comparing self-monitoring or self-management of oral anticoagulation by adults with 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 identified 21 eligible trials, but the authors were not able to obtain adequate data on 10 of the trials, therefore, they included data on 6417 participants from the other 11 trials. In a pooled analysis, there was a statistically significant reduction in thromboembolic events in the home PT monitoring group compared with 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).

Representative RCTs enrolling patients initially managed in a physician’s office or anticoagulation clinic are described next.

In 2010, Matchar et al published findings from a large nonblinded multicenter Veterans Administration‒ sponsored randomized trial.4,5 The trial, called the Home INR Study (THINRS), included patients who were taking warfarin because of MHVs and/or AF and were expected to be on warfarin indefinitely (operationally defined as 2 years). To be eligible, patients needed to participate in home monitoring training and pass a competency evaluation. A total of 3643 were trained and 2922 (80%) were randomly assigned to self-testing with an approved device once a week (n=1465) or monthly clinic-based testing (n=1457). There were 237 (8%) patients who required caregiver support to perform INR testing. Clinics in the study were required to be “high-quality” testing sites, defined as having a designated staff member for patient evaluation and follow-up, using a standard local protocol, and performing INR testing about once a month. Patients in the home monitoring group contacted the clinic with their test results. All participants had quarterly in-person evaluations. About 98% of the patients were men, 92% were white, and 92% had received anticoagulation treatment for at least 3 months. There were 1201 (82%) patients with AF and 351 (24%) with MHVs; 1113 (76%) had AF without MHV. Loss to follow-up was low and similar in the 2 groups, about 1%.

The primary efficacy outcome was time to the first major event (stroke, major bleeding episode, or death) and used Kaplan-Meier analysis; there were 8730 patient-years of follow-up. A total of 271 (19%) of patients in the self-testing group and 285 (20%) in the clinic-testing group experienced a major event. There was no statistically significant difference in time to first major event between groups (unadjusted HR=0.88; 95% CI, 0.75 to 1.04). Moreover, there were no significant between-group differences for the individual components of the primary outcome. For example, the rate of death was 152 (10%) in the selftesting group and 157 (11%) in the clinic-testing group (unadjusted HR=0.91; 95% CI, 0.73 to 1.12). However, the time during which the INR was in the therapeutic range, a secondary outcome, was somewhat higher in the self-testing group than the clinic-testing group (absolute difference, 3.8%; 95% CI, 2.7% to 5.0%); this difference was statistically significant (p<0.001). The investigators had hypothesized that home testing would be superior to clinic-based testing. They interpreted their finding of no difference between groups in the primary outcomes as an indication that there is no substantial negative effect of self-testing, and they recommended self-testing for patients who have limited access to high-quality anticoagulation clinics.

In a study published in 2005, Fitzmaurice et al randomized 617 patients older than age 18 years and receiving warfarin (50% for AF) to intervention or routine care.6 Patients receiving intervention used a point-of-care device to measure INR twice a week and a simple dosing chart to interpret their dose of warfarin. No significant differences were found in percentage of time in the therapeutic range between  self-management and routine care (70% vs 68%). Self-managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient-years) had serious adverse events in the self-managed group, compared with 7 patients (2.7/100 patient-years) in the routine care arm. The authors concluded that, with appropriate training, selfmanagement was safe and reliable for a sizeable proportion of patients receiving oral anticoagulation and may improve the time spent in the therapeutic range for patients with initially poor control.

In a European study published in 2005, Menendez-Jandula et al reported on 737 patients with indications (50% had AF) for anticoagulant treatment.7 The self-management group (n=368) received simple instructions for using a portable coagulometer weekly and self-adjusting treatment dose. The conventional management group (n=369) received usual care in an anticoagulation clinic (monthly measurement and control of INR, managed by hematologists). The median follow-up period was 11.8 months. The unadjusted percentages of in-range INRs were 58.6% in the self-management group and 55.6% in the conventional management group (95% CI for difference, 0.4 to 5.4 percentage points). Twenty-seven patients (7.3%) in the conventional management group and 8 (2.2%) in the selfmanagement group had major complications related to anticoagulant treatment; the unadjusted risk difference for major complications between groups was 5.1 percentage points (95% CI, 1.7 to 8.5 percentage points). This trial was performed at only 1 center and was not blinded. The dropout rate in the intervention group was 21%.

Section Summary

Home INR monitoring is feasible for some patients on warfarin, but a large proportion are unable or unwilling to perform home monitoring. For patients who are able to self-monitor and who are suitably trained, evidence from multiple RCTs demonstrates that home monitoring is associated with better INR control.

Data from multiple randomized controlled trials (RCTs) consistently demonstrate that the use of self monitoring in patients who are initially managed in a clinical setting results in an increased time in the therapeutic range. Based on prior research, it is likely that time in therapeutic international normalized ratio (INR) is associated with improved health outcomes. Some studies also report a lower rate of hemorrhagic or embolic events, but this evidence is limited by high dropout and noncompliance rates that may have created imbalances between treatment groups. The evidence includes monitoring in several chronic conditions such as mechanical heart valves, chronic atrial fibrillation, and deep venous thrombosis, and therefore comparable results should be able to be obtained in other similar, but less prevalent, conditions that require continuous anticoagulation. Thus, based on the evidence and clinical context, home prothrombin time monitoring may be considered medically necessary for patients with chronic conditions that require continuous oral anticoagulation with warfarin who are able to self-monitor and who have undergone initial clinic-based anticoagulation management for at least 3 months.

Population Reference No. 2

Home Self-Monitoring From the Start of Outpatient Treatment

Initiation of anticoagulation in the outpatient setting is more challenging than maintenance therapy. During the first few months of anticoagulation, INR levels require frequent monitoring and adjustment of Coumadin dose. The risk for adverse events is also higher during this period, particularly for hemorrhagic complications. As a result, the outcome of hemorrhagic complications is more important during this period compared with maintenance therapy.

Fewer RCTs have evaluated home PT monitoring beginning at or near the time they initiate oral anticoagulation therapy than in patients on a stable regimen of anticoagulant therapy. However, there are some published RCTs, which are described next:

Findings from the first 600 patients who completed the 2-year follow-up of the Early Self-Controlled Anticoagulation Trial (ESCAT) from Germany were published in 2001. 8 All patients had undergone mechanical heart valve replacement. A total of 295 patients were in the conventional group and 305 were in the INR self-management group. Self-management included training in use of the CoaguChek device 6 to 11 days after surgery and receiving a device after successful training. In the conventionally managed group, 62% of recorded INR values were within the stipulated range (2.5-4.5) during the entire observation period compared with 79% of INR values in the self-management group (p<0.01). Differences in the rate of complications did not differ significantly between groups. Rates of hemorrhagic events were 2.6% in the conventionally managed group and 1.7% in the self-management group, and rates of thromboembolic events were 2.1% and 1.2%, respectively (p>0.05).

In 2009, Hamad et al in The Netherlands published an RCT with 62 patients who had elective mechanical aortic valve replacement.9 Patients were randomly assigned to conventional management or selfmanagement using the CoaguChek device. Self-monitoring training was provided 3 weeks after surgery. After training, patients were supervised by clinic staff, and they had to pass an exam on self-monitoring before using the CoaguChek device at home. A total of 58 of 62 (94%) completed the 1-year follow-up; 29 in each group. The mean number of INR values per patient within the target range (2.5-4.5) was significantly higher in the self-management group (72.9%±11%) than in the conventionally managed group (53.9%±14%) (p=0.01). In addition, the mean number of days the INR value for each patient was outside the target range was significantly higher in the conventionally managed group (28.6±14) than the  self-monitoring group (22.2±10) (p<0.001). There were no significant differences between groups in postoperative complications or the mortality rate within 1 year of the operation.

In 2012, Thompson et al at Mayo clinic published an RCT evaluating in-hospital initiation of INR selftesting after mechanical heart valve replacement.10 Patients were not selected for participation based on motivation for self-testing. A total of 200 patients were randomized to self-testing (n=100) or usual care (n=100). Both groups received education on warfarin anticoagulation including a class, video, and an informational booklet. The self-testing group additionally received a structured education program on early postoperative self-testing which included an overview of INR self-testing, proper methods for sampling using a finger stick, use of the coagulometer, and recording of the test results. A Food and Drug Administration‒cleared device was used. Patients in the self-testing group performed tests once a week, used the telephone to record results, and phoned their physician for warfarin dosing instructions. The need for additional testing was at the discretion of the physician. For patients in the usual care group, frequency of testing and dose alteration was at the discretion of the primary physician.

During the 3-month study period, 14 patients (14%) withdrew from the self-testing group and 7 (7%) withdrew from the usual care group. Over the entire 3-month study period, the mean percentage of time patients spent in the INR therapeutic range was 53% (SD=27%) in the self-testing group and 48% (SD=25%) in the usual care group. The difference between groups was not statistically significant. However, when only data from the third month were examined, ie, the month in which patients were most experienced at self-testing, the self-testing group had a significantly greater percentage of time in the therapeutic range, 59% (SD=32%) versus 40% (SD=38%) (p=0.01). During the study period, a total of 9 patients (9%) in the self-testing group and 7 patients (7%) in the usual care group experienced an adverse event. In the self-testing group, adverse events included transient ischemic attack (TIA) (n=2), hemothorax (n=2), evacuation of subdural hematoma (n=1), bloody pericardial effusion (n=2), pulmonary embolism (n=1), and bleeding scalp (n=1). Adverse events in the usual care group included TIA (n=1), possible TIA (n=1), temporary visual change (n=2), bloody pericardial effusion (n=1), bleeding after shaving (n=1), and nose bleed (n=1). The study was powered to detect clinically significant differences in time within the therapeutic range, not to detect differences in adverse events.

Section Summary

There are fewer RCTs evaluating home monitoring in the initial treatment period compared with home monitoring that begins after several months of in-clinic management. Several European RCTs, which included substantial patient training and/or supervision, found that time in the therapeutic range improved with self-monitoring. A recent U.S. trial found from Mayo clinic found that time in the therapeutic range over the 3-month study period did not differ significantly in a self-monitoring versus usual care group. However, time in the therapeutic range was significantly higher in the self-monitoring group during the third study month, at which time patients had gained experience. The evidence supports that time in therapeutic INR can be improved with home monitoring, when patients are competent in the monitoring procedures, but the evidence on adverse events is not sufficient. In particular, the available studies have low numbers of hemorrhagic complications and may be underpowered to detect clinically important differences in that outcome.

The evidence is insufficient to conclude that the use of initial self-monitoring improves the net health outcome. RCTs with sufficient large samples that report health outcomes are needed to more thoroughly evaluate the safety and efficacy of home prothrombin time monitoring from the start of treatment. Therefore, the use of home monitoring during the initial treatment period is considered investigational.

Suplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Chest Physicians

In 2012, the American College of Chest Physicians published evidence-based guidelines on management of anticoagulant therapy.11 The guidelines include the following recommendations on home prothrombin time testing: “For patients treated with VKAs [vitamin K antagonists] who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than usual outpatient INR monitoring (Grade 2B). For all other patients, we suggest monitoring that includes the safeguards in our best practice statement 3.5.” These safeguards include managing treatment in a systematic and coordinated fashion, educating patients and communicating effectively with patients about test results and dosing decisions.

Medicare National Coverage

On December 20, 2007, the Centers for Medicare and Medicare Services issued a decision memo on home prothrombin time monitoring.12 The memo expanded the indication for home prothrombin timemonitoring from only including patients with mechanical heart valves to also including patients with chronic atrial fibrillation and deep venous thrombosis. The 2007 memo specified that coverage was for beneficiaries who had been taking anticoagulants for at least 3 months before use of the home device, had undergone an educational program on anticoagulation management, and were conducting selftesting with the device no more frequently than once a week.

References

1. Anthem Provider News. (2021, July 1). Proper coding for in-home monitoring can make a measurable difference for INR. Anthem.com. https://providernews.anthem.com/indiana/articles/proper-coding-for-in-home-monitoring-can-make-a-measurable-difference-for-inr-2

2. Centers for Medicare & Medicaid Services. NCA - Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087R) - Decision Memo. (2023). Cms.gov. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=209.  Accesed November 1, 2023.

3. Coordinated Care Health. (2023). Clinical Policy: Home Prothrombin Time Monitoring. In https://www.coordinatedcarehealth.com/. https://www.coordinatedcarehealth.com/content/dam/centene/Coordinated%20Care/policies/clinical-policies/508-WA.CP.MP.207-Home-Prothrombin-Time-Monitoring.pdf‌

4. ‌Garcia-Alamino JM, Ward AM, Alonso-Coello P, Perera R, Bankhead C, Fitzmaurice D, Heneghan CJ. Self-monitoring and self-management of oral anticoagulation. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD003839. doi: 10.1002/14651858.CD003839.pub2. Update in: Cochrane Database Syst Rev. 2016;7:CD003839. PMID: 20393937.  Accesed November 1, 2023.
5. Bloomfield HE, Krause A, Greer N, Taylor BC, MacDonald R, Rutks I, Reddy P, Wilt TJ. Meta-analysis: effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes. Ann Intern Med. 2011 Apr 5;154(7):472-82. doi: 10.7326/0003-4819-154-7-201104050-00005. PMID: 21464349.  Accesed November 1, 2023.
6. Heneghan C, Ward A, Perera R; Self-Monitoring Trialist Collaboration; Bankhead C, Fuller A, Stevens R, Bradford K, Tyndel S, Alonso-Coello P, Ansell J, Beyth R, Bernardo A, Christensen TD, Cromheecke ME, Edson RG, Fitzmaurice D, Gadisseur AP, Garcia-Alamino JM, Gardiner C, Hasenkam JM, Jacobson A, Kaatz S, Kamali F, Khan TI, Knight E, Körtke H, Levi M, Matchar D, Menéndez-Jándula B, Rakovac I, Schaefer C, Siebenhofer A, Souto JC, Sunderji R, Gin K, Shalansky K, Völler H, Wagner O, Zittermann A. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet. 2012 Jan 28;379(9813):322-34. doi: 10.1016/S0140-6736(11)61294-4. Epub 2011 Nov 30. Erratum in: Lancet. 2012 Mar 24;379(9821):1102. PMID: 22137798.  Accesed November 1, 2023.
7. Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617. Erratum in: N Engl J Med. 2011 Jan 6;364(1):93. PMID: 20961244.  Accesed November 1, 2023.
8. Matchar DB, Jacobson AK, Edson RG, Lavori PW, Ansell JE, Ezekowitz MD, Rickles F, Fiore L, Boardman K, Phibbs C, Fihn SD, Vertrees JE, Dolor R. The impact of patient self-testing of prothrombin time for managing anticoagulation: rationale and design of VA Cooperative Study #481--the Home INR Study (THINRS). J Thromb Thrombolysis. 2005 Jun;19(3):163-72. doi: 10.1007/s11239-005-1452-0. PMID: 16082603.  Accesed November 1, 2023.
9. Fitzmaurice DA, Murray ET, McCahon D, Holder R, Raftery JP, Hussain S, Sandhar H, Hobbs FD. Self management of oral anticoagulation: randomised trial. BMJ. 2005 Nov 5;331(7524):1057. doi: 10.1136/bmj.38618.580903.AE. Epub 2005 Oct 10. Erratum in: BMJ. 2005 Dec 3;331(7528):1330. PMID: 16216821; PMCID: PMC1283185.  Accesed November 1, 2023.
10. Menéndez-Jándula B, Souto JC, Oliver A, Montserrat I, Quintana M, Gich I, Bonfill X, Fontcuberta J. Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Ann Intern Med. 2005 Jan 4;142(1):1-10. doi: 10.7326/0003-4819-142-1-200501040-00006. PMID: 15630104.  Accesed November 1, 2023.
11. Meridian Health Policy and Procedure Manual. (2020, January 20). Home INR Monitor . Www.ilmeridian.com. https://www.ilmeridian.com/content/dam/centene/meridian/il/pdf/home-inr-monitor.pdf
12. Körtke H, Körfer R. International normalized ratio self-management after mechanical heart valve replacement: is an early start advantageous? Ann Thorac Surg. 2001 Jul;72(1):44-8. doi: 10.1016/s0003-4975(01)02656-x. PMID: 11465228.  Accesed November 1, 2023.
13. Soliman Hamad MA, van Eekelen E, van Agt T, van Straten AH. Self-management program improves anticoagulation control and quality of life: a prospective randomized study. Eur J Cardiothorac Surg. 2009 Feb;35(2):265-9. doi: 10.1016/j.ejcts.2008.10.020. Epub 2008 Nov 28. PMID: 19041254.  Accesed November 1, 2023.
14. Thompson JL, Burkhart HM, Daly RC, Dearani JA, Joyce LD, Suri RM, Schaff HV. Anticoagulation early after mechanical valve replacement: improved management with patient self-testing. J Thorac Cardiovasc Surg. 2013 Sep;146(3):599-604. doi: 10.1016/j.jtcvs.2012.03.088. Epub 2012 Aug 24. PMID: 22921821.  Accesed November 1, 2023.
15. Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH. 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 Feb;141(2 Suppl):e152S-e184S. doi: 10.1378/chest.11-2295. PMID: 22315259; PMCID: PMC3278055.  Accesed November 1, 2023.
16. Schulman, S. (2012). Evidence-Based Management of Anticoagulant Therapy. Chest, 141(2), e152Se184S. https://www.academia.edu/89201095/Evidence_Based_Management_of_Anticoagulant_Therapy. Accesed November 1, 2023.
17. Premera Blue Cross. (2023) 1.01.536 Home Prothrombin Time/International Normalized Ratio (PT/INR) Monitoring. In https://www.premera.com.  https://www.premera.com/medicalpolicies-individual/1.01.536.pdf#search=inr%20monitoring. Ref. Policy: MP-068 Effective Date: Nov. 1, 2023 Last Revised: Oct. 23, 2023 

Codes

Policy History