Home Discover INR self-testing with CoaguChek from Roche

Table of Content

• Prothrombin Time (INR) Home Testing Devices
• Venous Thromboembolism
• Home Care Services
• Page Help for NCA - Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087N) - Decision Memo
• Prothrombin Time (INR) Monitor for Home Anticoagulation Management
• Welcome to a New Generation of INR Self-Testing

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.

Learn more about CoaguChek devices for professional use and the different models of patient monitoring. The proposed decision memo is typically posted 6 or 9 months after the opening of the NCA or CAL and gives the reader an idea of the direction the review is headed. Consistent with 1862, CMS provides 30 days for public comment on the aforementioned proposal. Methodological strength is, therefore, a multidimensional concept that relates to the design, implementation and analysis of a clinical study. In addition, thorough documentation of the conduct of the research, particularly study selection criteria, rate of attrition and process for data collection, is essential for CMS to adequately assess and consider the evidence. Compared to sending the test to an outside laboratory, the immediate availability of test result information allows the treating physician to make dosage adjustments, if needed, more quickly.

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.

Coverage criteria should not include burdensome language or requirements and the warfarin managing provider should be the responsible entity to assess and document anticoagulation. Another comment notes that while home self testing for PT/INR is beneficial for many patients, not all patients should be allowed or encouraged to self test. In addition, geriatric population would have problems checking PT/INR by themselves at home.

Venous Thromboembolism

Patient self testing training should be provided to beneficiaries by a physician or pharmacist. The comment requested information on billing Medicare for pharmacist services rendered through a warfarin clinic under a physician protocol performed by pharmacist. For an item or service to be covered by the Medicare program, it must fall within one or more of the statutorily defined benefit categories outlined in the Social Security Act . The information provided supports continuing the current benefit category of the Act section 1861, “diagnostic laboratory tests and other diagnostic tests,” for the new indication. The information and resources on this website are intended to provide useful information for patients and caregivers who are using INR test meters in the home and for health care providers using INR test meters in a clinical setting.

It is important to state here that the scope of this decision is specific to home PT/INR monitoring and does not apply to other PT/INR monitoring that may be undertaken to address the labeled recommendation. This decision does not prohibit the provision of this service through the beneficiary’s primary treating physician or an anticoagulation clinic. There were no significant differences between the two groups in the percentage time in range or the proportion of test in range.

Home Care Services

Another comment took exception to the new requirement that beneficiaries continue to correctly use the device following initial training. The comment stated that the Local Medicare contractor could interpret this as requiring a burdensome certification process. The commenter recommends that the final NCD include language specifying that physician documentation in medical record of the patient’s continued correct use of the device is sufficient to meet this requirement. Though there are many published guidelines on the topic of anticoagulation therapy, we did not find any evidence based guidelines that specifically address home PT/INR testing. Patients overwhelmingly reported satisfaction with the ease of the use of the device and preferred the home monitoring over the venous blood collection at the clinic.

If the dose of warfarin is too high, the patient may be at risk of serious bleeding. It can be monitored by drawing blood from a vein and sending the blood to an accredited laboratory to test, or it can be monitored by testing blood from a fingerstick with an INR test meter outside of a laboratory. INR test meters may be prescribed to patients for use in the home, and they may also be used by health care providers at the point of care, such as a health care setting.

Every patient with a mechanical heart valve may not be a good candidate for using these devices. The use of these devices requires some manual dexterity and an ability to follow instructions. All patients with mechanical heart valves need to be anticoagulated, whereas some patients with atrial fibrillation may not be anticoagulated (e.g. young, non-valve AF). This select group of patients would likely be especially receptive to the use of home INR monitors, and thus achieve the greatest benefit. Now, there could be concern that a testing frequency bias exists, i.e. by simply testing more often, values will be more likely to have less variation. The patients using home monitors tested much more often, as a group, than those patients going to physician offices, or anticoagulation clinics.

In-home testing only requires a finger stick, instead of a full blood sample. The instructions will include a toll-free phone number that you can use to contact the manufacturer if you have questions about how to use the meter.

National coverage determinations are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act, § 1869. In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member” (§ 1862). This section presents the agency's evaluation of the evidence considered and conclusions reached for the assessment questions.

For both atrial fibrillation and deep vein thrombosis, approximately 69% of the INR values were within the therapeutic range. For patients with atrial fibrillation, 126 reported hemorrhagic complications and 25 reported thromboembolic events. For those with deep venous thrombosis, 145 patients reported hemorrhagic complications and 22 reported thromboembolic events. The authors concluded that self-management of oral anticoagulation is a reliable option and is suitable for monitoring therapy in patients with atrial fibrillation and deep vein thrombosis. The incidence for patients with mechanical valves is 8% per year; for patients with atrial fibrillation, 4.5% (range 3-10%) per year. With proper anticoagulation, the rate decreases to 2% for patients with mechanical heart valves; for atrial fibrillation, it decreases to 1.5% .

The companies that provide the machines/training will remind you to submit your report if they don’t hear from you within a couple of weeks. “Once you’re determined to be a good candidate for self-testing, your provider or pharmacy team will go through a company that handles training and INR test results,” explained Dr. Collins. “Typically, these companies send a trainer out to your home to review how to use the machine correctly and help you report the results for the first time.” Trainings can also be done virtually. In the midst of the COVID-19 pandemic, all trainings have shifted to a virtual platform.

Therefore, we see no need to change the current nationally covered frequency limitation. Some have noted that more frequent testing could be needed if a patient begins a new medication that may affect the metabolism of warfarin and thereby the INR. While we do not dispute that assertion, we point out that this NCD speaks only to testing performed in the home. If a patient’s condition has been destabilized by a change in medication or other factor, the patient may benefit from more rather than less direct attention from the treating physician. All studies had patients self-test and self-manage with a physician-prescribed algorithm.

What is an INR Test?

ACS will then take care of everything to get you started from verifying your insurance coverage and benefits to obtaining a prescription from your physician. Home INR testers are not only convenient but has been proven to significantly reduce the risk of costly complications and emergency admissions for patients on long-term Coumadin or warfarin therapy. However, many warfarin patients choose self-testing for the freedom and convenience it provides. Once your doctor or healthcare provider receives your results, they will contact you if any changes are or are not necessary for your warfarin dose. Patients with mechanical heart valves have a greater incidence of thrombus formation, and this thrombus may be slightly different than thrombi developed in other conditions. Testing at home allows not only for an increased frequency of testing, but also improved timeliness, providing the ability to perform the test when it is needed.