Prothrombin Time (INR) Monitor for Home Anticoagulation Management

The prothrombin time (PT) test is an in-vitro test to assess coagulation. PT testing and its normalized correlate, the International Normalized Ratio (INR), are the standard measurements for therapeutic effectiveness of warfarin therapy.

Currently, Medicare’s national coverage determination (NCD) at 190.11 of the NCD Manual limits coverage of home PT/INR monitoring to anticoagulation management for patients with mechanical heart valves who are on warfarin. The monitor and the home testing must be prescribed by a treating physician as provided at 42 CFR 410.32(a) and the following requirements must be met:

1. The patient must have been anticoagulated for at least three months prior to use of the home INR device;
2. The patient must undergo an educational program on anticoagulation management and the use of the device prior to its use in the home; and
3. Self-testing with the device should not occur more frequently than once a week.

We have received a formal complete written request for reconsideration under the auspices of the Prothrombin-Time Self Testing Coalition via its counsel McDermott Will & Emery LLP, signed by Larry Cohen of International Technidyne Corporation, David Phillips of HemoSense, Inc. and John Ridge of Roche Diagnostics Corporation.  The requestor asks CMS to expand the population eligible for coverage of home PT/INR monitoring to patients on warfarin without regard for the underlying condition that determines the need for warfarin, as the black box warning on the label for warfarin states that “Regular monitoring of INR should be performed on all treated patients.”  The requestor has alternatively asked for the addition of atrial fibrillation and deep vein thrombosis as covered indications.  The requestor also asks that we leave intact the three requirements enumerated above.

June 26, 2007

December 20, 2007

March 19, 2008