Prothrombin Time INR Home Testing Devices Medical Clinical Policy Bulletins

Table of Content

• Prothrombin Time (INR) Home Testing Devices
• CMS & HHS WEBSITES
• INR Testing at Home: What You Need to Know
• Page Help for NCA - Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087N) - Decision Memo
• High Blood Pressure: What it Is & Why it Matters
• Training You on the PT/INR Testing Device
• Home INR Testing and Monitoring Helps Manage Conditions Including:

He examined outcomes of patients with mechanical valves between those that self-tested and self-managed with a home device, versus those that underwent laboratory testing by their physicians. Home INR patients tested once every 4 days versus once every 19 days in the usual care group. The home testing patients also demonstrated a high degree of compliance with the testing schedule and treatment algorithm. The investigators randomized 84 patients who had received long-term oral anticoagulation for at least 8 months to either patient self-testing or the control group. Patients in the self-testing group had face-to-face training and then tested themselves at home once a week and recorded the result for a 6-month period.

The evidence for a benefit for home INR monitoring is clearest for patients with mechanical heart valves. Review of the studies demonstrate that most patients enrolled in the studies were patients with mechanical heart valves. Although there were numerous indications, 90% of the patients in the studies reviewed were using the monitor for a mechanical heart valve.

Prothrombin Time (INR) Home Testing Devices

MdINR is available to answer your questions and provide ongoing technical support. The required test strips will be mailed to you, and any defective devices will be replaced. “The testing machines themselves only have two buttons and are pretty easy to use. Patients who have diabetes will be familiar with this type of machine – it follows the same process as testing blood sugar. The most important thing is to make sure that you get enough blood on the test strip,” says Dr. Collins.

Warfarin therapy may be prescribed for patients with certain types of irregular heartbeat, blood clots in the legs or lungs, and patients who have certain medical device implants such as artificial heart valves. Ask your health care provider to periodically compare your INR test meter results with the results from a laboratory test. If possible, your health care provider should use the same laboratory each time for consistency.

CMS & HHS WEBSITES

This primarily new body of literature demonstrates that the use of the home INR monitor is at least equivalent to lab/testing or physician office testing with respect to TTR. The studies are consistent in demonstrating that the use of the home INR monitor significantly increases TTR. There was no study that showed these home devices resulted in decreased, or equivalent TTR. The studies, which were conducted by different investigators at different sites, with different patient populations, and spread over a decade, were all consistent.

Medicare local contractors may consider on a case-by-case basis the ability of a caregiver to assist the patient. Limitations were that there was no report of the percentage of eligible participants who enrolled, it was not blinded and there is no report of the indications for anticoagulation except to say that they were mostly for atrial fibrillation. Regardless, the authors conclude that the results support self-management as a feasible model of anticoagulation management. The unanticipated early dropout of 13 patients from the self-management arm (before starting self-management) reduced the power to detect a significant difference in the complication rates between the groups. Bias may have been introduced with the monthly contact between pharmacist and patient only for those patients in the self-management arm. Additionally, only the self management group received education about warfarin and it is unclear if this might have biased the results.

INR Testing at Home: What You Need to Know

This site is not designed to and does not provide medical advice, professional diagnosis, opinion, treatment, or services to you or any individual. After testing your blood, you’ll have to report the results to the company you’re working with. The company will also manage billing and the insurance-related parts of the process. When your provider receives your results, they can make dosage adjustments as needed. PT/INR testing is a fact of life for all patients who take the anti-coagulants Coumadin or warfarin.

Because of the concerns of adverse events, several studies have been conducted to examine the use of patient self testing and self management. The hypothesis behind these studies was if patients could have a less burdensome way to monitor their anticoagulation, they would in turn have better control or at least fare no worse than with routine care. As noted at the beginning of this document, there are numerous indications for anticoagulation, some more generally accepted than others. It is universally agreed that all patients with mechanical heart valves need to be anticoagulated.

Page Help for NCA - Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087N) - Decision Memo

The applicability of the results of a study to other populations, settings, treatment regimens and outcomes assessed is known as external validity. Even well-designed and well-conducted trials may not supply the evidence needed if the results of a study are not applicable to the Medicare population. Evidence that provides accurate information about a population or setting not well represented in the Medicare program would be considered but would suffer from limited generalizability. Not every patient with an indication for long term anticoagulation will be a good candidate for using these devices. Finally, many studies have shown that only highly motivated patients should be enrolled in self-testing. This will likely be a minority of the patients potentially considered for this mode of testing.

Patients in the intervention group attended two face-to-face training sessions led by nurses. Intervention patients managed their own anticoagulation therapy for 12 months. The main outcomes of interest were the percentage of time spent within the therapeutic range and adverse events. There was no relationship between the percentage of INR tests within target range or the time within target range and age, educational level, or indication for oral anticoagulant treatment. The authors concluded that patient self-management of oral anticoagulation treatment is similar to management by a specialized clinic when measured by the quality of INR control.

High Blood Pressure: What it Is & Why it Matters

When you receive your new CoaguCheck Vantus, the Remote INR team will teach you how to use it. Representatives can answer any questions you might have about the process of test your INR. Many things can alter your INR, including stress, missing a dose of your vitamin K antagonist therapy, taking herbal supplements and other medications, and consuming certain foods and beverages, such as kale and cranberry juice. Alcohol can increase the effect of your medication and further slow your clotting rate, causing your INR to be too high. 7 Therapeutic index relates the dose of a drug required to produce a desired effect to that which produces an undesired effect (median toxic dose/median effective dose). Two studies did demonstrate a statistically significant difference in event rates; these studies were ESCAT and Beyth.

Samsa and Matchar defined the two intermediate outcomes most used in the anticoagulation literature. This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service. We recommend using a laboratory test for confirmation when INR results are above 4.5.

Prior to any new or modified policy taking effect, CMS must first issue a manual instruction giving specific directions to our claims-processing contractors. If appropriate, the Agency must also change billing and claims processing systems and issue related instructions to allow for payment. Policy changes become effective as of the date listed in the transmittal that announces the Coverage Issues Manual revision. For instance, many studies had only 10-20% enrollment rates from the eligible population (Gardiner 2004, 2005; Fitzmaurice 2005; Voeller 2005) and one was discontinued due to low enrollment (Völler 2005). We are therefore challenged to generalize the conclusions beyond patients who have demonstrated capability and motivation for undergoing a self-management and self-training education session and for the ongoing use of the monitor over time. Another comment supports coverage through the beneficiary’s physician office or through an anticoagulation clinic.

For consistency, unless citing the work of others, we will use the terms “PT”, “INR” and/or “PT/INR” in this memorandum to refer to the measurement of anticoagulation with the prothrombin time and/or the international normalized ratio. Unless citing the work of others, we use the term "TTR" in this memorandum to refer to time in therapeutic target range. This is defined as the number of patient-days of follow-up which were within target range divided by the total number of patient-days included in the follow-up period .