Medicare Announces Expanded Coverage for Warfarin Patients Monitoring Clotting Time at Home

Decision makes convenient self-testing a financial reality for more anticoagulation patients

INDIANAPOLIS, March 19, 2008 /PRNewswire/ -- Medicare Part B will now cover and pay for meter training, equipment and supplies for all long-term warfarin users who monitor their prothrombin time at home with a portable handheld meter. The change opens the door to greater convenience and potentially fewer complications for a broader spectrum of anticoagulation patients.

Medicare previously reimbursed these expenses only for patient self- testers who had mechanical heart valves. The new coverage expands to include those on anticoagulant medication with chronic atrial fibrillation and venous thromboembolism.

"This expanded coverage will give more warfarin patients the flexibility to test when and where they want," said Dr. Alan Jacobson, cardiologist, Loma Linda University School of Medicine. "Now, patients who travel extensively or who have difficulty with access to their doctor's office or a centralized location can monitor their INR at home. If they test more often, it's easier to manage their therapy and keep their medication in the therapeutic range."

Some patients travel to their doctor's office or an anti-coagulation clinic as often as once a week to make sure their warfarin is appropriately regulated. While warfarin is commonly prescribed to prevent thrombosis, or blood clots, it must also be carefully monitored to prevent bleeding.

Portable, handheld prothombin time (PT/INR) meters, like the CoaguChek(R) XS System for Patient Self-Testing, enable patients to test their clotting time at home in about a minute, using a small drop of blood from a simple fingerstick. Currently, in the United States, less than 5 percent of patients on blood thinners perform self-testing, according to the Centers for Medicare and Medicaid Services.

Studies suggest that anticoagulation patients who self-test may experience fewer complications overall than those who do not, because self-testing may increase patient time in therapeutic range.(1) Studies also suggest that PT/INR self-testing (performed with a blood sample from a fingerstick) is just as accurate as fingerstick testing performed by a healthcare professional and conventional testing performed on a laboratory analyzer.(2,3,4)

"I feel comfortable with more of my patients monitoring from home because handheld meters like the CoaguChek XS System are easy to use, and I know the results will be as reliable as results from our office meter and from the lab," said Dr. Jacobson. "Plus, this gives my patients the convenience of testing at home with a simple fingerstick rather than having blood drawn from their arm and waiting for lab results."

Under the new Medicare B policy, the patient portion of costs for self- testing is expected to be about $30 a month (based on a national average) for the use of a PT/INR meter and test strips, and about $35 for the initial training. Patients with supplemental insurance coverage could potentially have little or no out-of-pocket expenses.

All patients on anticoagulant medication need a prescription from their doctor for a self-testing meter and supplies before being able to monitor their own clotting time at home. Patient self-testing is also designed to augment, not eliminate, testing and therapy management that is overseen by a doctor. Patients who self-test notify their doctors of clotting time results so they can make the proper adjustments to medication.

Patients interested in finding out more about self-testing their PT/INR should talk to their doctor. For more information on the CoaguChek XS System for Patient Self-Testing, visit www.ASmartWayToTest.com.

About Anticoagulation Monitoring

Certain patients with atrial fibrillation, a mechanical heart valve or deep vein thrombosis require protection against thrombosis, or blood clots. They are typically put on lifelong oral anticoagulation therapy with warfarin sodium (e.g., Coumadin) to thin their blood. Each patient reacts differently to anticoagulant medications, so it is imperative to monitor therapeutic effects closely to minimize potential risks.

About CoaguChek products

Physicians have been using CoaguChek instruments for point-of-care PT/INR testing since 1994. Today, in the U.S., more point-of-care PT/INR tests are performed with a CoaguChek system than with all other devices combined.(5) The CoaguChek XS System represents the fifth generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007, sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested more than 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at www.roche.com.

    References

    (1) Kortke H, Minami K, Breymann T, et al. INR self-management after

        mechanical heart valve replacement: ESCAT. Z Kardiol. 2001;90 (6)118-

        124.

    (2) CoaguChek XS system package insert. Indianapolis, IN.  Roche

        Diagnostics Corporation; 2006.

    (3) Bussey HI, Chiquette E, Bianco TM, et al. A statistical and clinical

        evaluation of fingerstick and routine laboratory prothrombin time

        measurements. Pharmacotherapy. 1997;17(5): 861-866.

    (4) Kaatz SS, White RH, Hill J, et al. Accuracy of laboratory and portable

        monitor international normalized ratio determinations. Comparison with

        a criterion standard. Arch Intern Med. 1995;155:1861-1867.

    (5) Second Quarter 2007 total market share of projected distributor unit

        sales of the Point of Care Testing Coagulation Reagents and Kits


        product class by HPIS Market Intelligence, a division of GHX Global

        Healthcare Exchange.

All trademarks used or mentioned in this release are legally protected by law.

    For further information, please contact:

    Media:                             Healthcare Professionals and Patients:

    Lori McLaughlin

    Corporate Communications

    Roche Diagnostics Corporation,

    Indianapolis, Ind.


    Phone: 317-521-3112                Phone : 1-800-852-8766

              Option 2 for Healthcare Professionals

                                       and Option 4 for Patients

lori.mclaughlin@roche.com

CONTACT: Media: Lori McLaughlin, Corporate Communications of RocheDiagnostics Corporation, +1-317-521-3112, lori.mclaughlin@roche.com

Web site: http://www.roche.com/http://www.ASmartWayToTest.com/

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Posted: March 2008


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