Coverage will be provided for 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. The monitor and the home testing must be prescribed by a treating physician and all of the following requirements must be met:

1. The patient must have been anticoagulated for at least 3 months prior to use of the home INR device; and,
2. 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
3. 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,
4. Self-testing with the device should not occur more frequently than once a week.

The diagnosis codes listed in the “Diagnosis Code” section of this policy are eligible diagnosis codes. Any service reported without a diagnosis code listed in the “Diagnosis Code” section of this policy will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Payment will not be made for home INR monitoring for patients with porcine valves.

Procedure code G0249 includes payment for both the device and the supplies. These items may not be separately billed. Procedure Code G0249 includes materials for 4 tests.

Procedure code G0250 is per four tests. Self-testing with the INR monitor is limited to once weekly. Therefore, this code should not be billed more than once every four weeks.

Description

Use of the International Normalized Ratio (INR) or prothrombin time (PT) – standard measurement for reporting the blood's clotting time – allows physicians to determine the level of anticoagulation in a patient, independent of the laboratory reagents used. The INR is the ratio of the patient’s PT (extrinsic or tissue-factor coagulation pathway) compared to the mean PT for a group of normal individuals.

Maintaining patients within his/her prescribed therapeutic range minimizes adverse events associated with inadequate or excessive anticoagulation, such as serious bleeding or thromboembolic events.

Patient self-testing and self-management through the use of a home INR monitor may be used to improve the time in therapeutic rate (TTR) for select groups of patients. Increased TTR leads to improved clinical outcomes and reductions in thromboembolic and hemorrhagic events.

Warfarin (also prescribed under other trade names, e.g., Coumadin®) is a self-administered, oral anticoagulant (blood thinner) medication that affects the Vitamin K-dependent clotting factors II, VII, IX, and X. It is widely used for various medical conditions, and has a narrow therapeutic index, meaning it is a drug with less than a 2-fold difference between median lethal dose and median effective dose. For this reason, since October 4, 2006, it falls under the category of a Food and Drug Administration (FDA) “black-box” drug whose dosage must be closely monitored to avoid serious complications. A PT/INR monitoring system is a portable testing device that includes a finger-stick and an FDA-cleared meter that measures the time it takes for a person’s blood plasma to clot.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

CMS Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Section 190.11

Transmittal AB-02-180, CR 2323

Transmittal 90, CR 6138

Transmittal 1562, CR 6138

Diagnosis Codes

289.81
415.11-415.19
427.31
451.0
451.11-451.19
451.2
451.81-451.89
451.9
453.0-453.3
V43.3