NCD190.11

 

HOME PROTHROMBIN TIME/INTERNATIONAL NORMALIZED RATIO (PT/INR) MONITORING FOR ANTICOAGULATION MANAGEMENT

 

Effective Date of this Version

• 8/25/2008

 

Benefit Category

• Diagnostic Tests (other).

• Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

 

Item/Service Description

 

General

• 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.

o 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.

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

o 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.

o 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.

o 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.

o 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.

o 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.

 

Indications and Limitations of Coverage

 

Nationally Covered Indications

• For services furnished on or after March 19, 2008, Medicare will cover 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 as provided at 42 CFR 410.32(a), and ALL of the following requirements must be met:

o The patient must have been anticoagulated for at least 3 months prior to use of the home INR device.

o 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.

o The patient continues to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring.

o Self-testing with the device should not occur more frequently than once a week.

Nationally Non-Covered Indications

• N/A

 

Other

• All other indications for home PT/INR monitoring not indicated as nationally covered above remain at local Medicare contractor discretion.

• This national coverage determination (NCD) is distinct from, and makes no changes to, the PT clinical laboratory NCD at section 190.17 of Publication 100-03 of the NCD Manual.

• (This NCD last reviewed March 2008)

 

Claims Processing Instructions

• TN 1562 (Medicare Claims Processing)

• TN 1663 (Medicare Claims Processing)

 

National Coverage Analyses (NCAs)

• This NCD has been or is currently being reviewed under the National Coverage Determination process.

• The following are existing associations with NCAs, from the National Coverage Analyses database.

• Original consideration for Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087N)

• First reconsideration for Prothrombin Time (INR) Monitor for Home Anticoagulation Management (CAG-00087R)

 

Medicare NCD Link