Medicare Proposes To Expand Coverage For Home Testing Of Prothrombin Time (PT) International Normalized Ratio (INR), USA

Main Category: Blood / Hematology
Also Included In: Medicare / Medicaid / SCHIP
Article Date: 21 Dec 2007 - 13:00 PDT

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The Centers for Medicare & Medicaid Services (CMS) proposed to extend Medicare coverage for home testing of blood clotting tendencies for certain beneficiaries.

In its proposed coverage decision, CMS seeks to expand coverage of home testing of prothrombin time (PT) International Normalized Ratio (INR) for beneficiaries who require the use of warfarin, an anticoagulant (blood thinner), approved for use in the treatment of chronic atrial fibrillation (a specified heart rhythm irregularity) and venous thrombosis (a condition that commonly manifests as a blood clot in the leg).

The INR provides a way to standardize the PT measurement of the anticoagulant effect of warfarin, and is commonly reported in seconds. Appropriate and timely measurements are important because anticoagulation is very sensitive -excessive anticoagulation (blood is too thin) may lead to severe or fatal bleeding while inadequate anticoagulation (blood is too thick) may allow blood clots to form in the bloodstream.

Medicare's current policy only provides home test coverage for Medicare patients with mechanical heart valves who are on warfarin. Today's proposal would be a significant expansion of coverage, as atrial fibrillation and deep venous thrombosis are much more common than mechanical heart valve implantation.

In addition to increasing the frequency of testing, the ability of being able to test at home and see the result immediately, may result in more regular testing. The proposed coverage decision includes consideration of the safety of anticoagulant drugs, including the recent U.S. Food and Drug Administration's recent Black Box Warning and approved labeling for this drug. The proposed change is consistent with the current evidence for these two conditions.

"This proposed change is expected to improve patient compliance and physician monitoring of anticoagulant therapy in terms of tracking INR levels and managing anticoagulant drug dosing," CMS Acting Administrator Kerry Weems said. "Patients would be able to test INR levels from the comfort of their home and alert their doctors via phone."

CMS plans to issue a final national coverage determination in March 2008. CMS invites public comments on its proposed decision. Instructions for the submission of comments may be found here.

Centers for Medicare & Medicaid Services