National Coverage Analysis (NCA) Tracking Sheet

Prothrombin Time (INR) Monitor for Home Anticoagulation Management

CAG-00087N

Issue

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

Currently, Medicare does not have a national coverage policy on the use of home monitoring with prothrombin time. The DMERCs do not have a regional medical review policy on this either. The DMERCs are denying claims for the use of the use of the PT home monitor as not being "medical necessary and reasonable. "

We are particularly interested in looking at patients with mechanical valves, and those patients with atrial fibrillation who have suffered a cerebrovascular event.

We have met and received many inquiries from representatives of manufacturers, clinicians, and professional associations and groups, expressing concerns and requests for the possibility of limited coverage for PT home monitors.

Benefit Category

Diagnostic Tests (other)

Requestor Information

Requestor Name Requestor Letter
Internal N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
01/29/2001
Expected NCA Completion Date
09/19/2001
Public Comment Period
02/28/2001 - 03/30/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
09/18/2001

Contacts

Lead Analysts
Francina Spencer
Lead Medical Officers
John Whyte, MD

Medicare Benefit Category Determination Date

Actions Taken

April 18, 2001

Due date extended to May 11, 2001 since additional time is needed to review materials.

May 11, 2001

Given complexity of issue, will extend due date to July 9.

September 19, 2001

Final Decision Memorandum  approved and posted.

May 2002

Claims processing instructions issued and NCD updated.