National Coverage Analysis (NCA) Tracking Sheet

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.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor NameRequestor Letter
Prothrombin-Time Self Testing Coalition View Letter

Important Dates

Formal Request Accepted and Review Initiated
Expected NCA Completion Date
Public Comment Period
06/26/2007 - 07/26/2007
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
12/20/2007 - 01/19/2008
Decision Memo Released
Comments for this NCA
View Public Comments


Lead Analysts
Francina Spencer
Lead Medical Officers
Shamiram Feinglass, MD, MPH

Actions Taken

June 26, 2007

CMS opens this reconsideration of the NCD on PT/INR monitoring for home anticoagulation management.  CMS will review evidence on the request and may review additional evidence to reconsider all aspects of the NCD.  The initial 30-day public comment period begins with this posting date and ends after 30 calendar days.  CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

Instructions on submitting comments can be found at

To submit comments, please use the orange "comment" button at the top of the page.

December 20, 2007

Posted Proposed Decision Memorandum. We invite comments on the Proposed Decision Memorandum.

Instructions on submitting comments can be found at

To submit comments, please use the orange "comment" button at the top of the page.

March 19, 2008

Final Decision Memorandum posted.