The announcement this past week from the Centers for Medicare & Medicaid Services (CMS) that Medicare coverage for at-home blood testing of prothrombin time (PT)/International Normalized Ratio (INR) will be expanded is welcome news to the millions of patients who take anticoagulants daily and will now have easier access to proactive, improved quality of health care. In addition to mechanical heart valve patients (for whom CMS approved weekly self-testing in 2002), the new decision expands coverage of home testing to those patients who take warfarin, an anticoagulant medication, for chronic atrial fibrillation or venous thromboembolism.
“Warfarin — a blood thinner used chronically by a large population of patients for a variety of medical conditions — is a very critical, black-box drug whose dosage needs to be managed closely in order to minimize serious complications from continual use, including blood clots, stroke and hemorrhage,” says Jack Ansell, M.D., an internationally recognized expert in hemostasis and thrombosis, and Chairman of Medicine at Lenox Hill Hospital in New York City. “The scientific research and success of mechanical heart valve patients with INR home testing for the past six years serve as proof that weekly patient home self-testing helps patients remain in their therapeutic range, thereby reducing the risk of costly — and deadly — complications.”
Dr. Ansell, whose main area of research focuses on the application of new modes of delivering and monitoring anticoagulants, is the founder and immediate past Chair of the Anticoagulation Forum, a network of anticoagulation clinics throughout North America. “This new CMS decision removes a substantial barrier to the wider use of patient self-testing for INR that we are hopeful will happen in the near future,” he says.
International Normalized Ratio (INR) is the standard unit for reporting the clotting time of blood, which must be tested on a regular basis in order for a person on anticoagulants to remain in his or her prescribed “range” For those with chronic atrial fibrillation or venous thromboembolism, it can mean monthly trips to the physician, clinic or lab for blood work, which imposes a tremendous burden on both the patient and the physician.
“Now that CMS has expanded coverage for these two additional patient groups on anticoagulation therapy, more Medicare beneficiaries will be eligible to self-test their INR more regularly in the comfort and convenience of their own homes,” says David Phillips, vice president of marketing at HemoSense®, manufacturer of the INRatio® PT/INR Monitoring System, an easy-to-use, portable device designed for home INR testing that is already being used successfully by thousands of mechanical heart valve patients on daily anticoagulants. “This decision helps bring the patient into the healthcare team to be more proactive in maintaining their own INR levels, which is a major step in preventing complications, and improving compliance.”
At-home INR testing, done with a finger prick and a specialized, FDA-cleared meter (similar to the process utilized by diabetics for glucose monitoring), includes a simple blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. “The optimal therapeutic range for patients with atrial fibrillation or venous thrombosis is an INR between two and three,” explains Dr. Ansell. “Should the patient’s level fall out of therapeutic range, it will be more readily detected with the weekly self-testing, allowing the doctor to make timely dosage changes in response.”
Atrial fibrillation is the most frequently encountered and sustained cardiac arrhythmia in clinical practice, affecting millions of patients nationwide. Venous thromboembolism, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects upwards of 500,000 people. “There is the now the potential for these patients to take an active role in monitoring their own health via the self-testing of their INR levels,” concludes Dr. Ansell.
For more information about INR self testing, visit www.hemosense.com.
Note to Media:
Dr. Ansell will be the keynote speaker of a media Web cast, addressing this new CMS decisionand the positive effects it can have on these new patients and their doctors, today,Thursday, March 27th, 10 a.m. ET (program time approximately 30 minutes).
Dr. Ansell will present for 15 minutes, with additional time allotted for media Q&A.
To register for this informative Web cast in order to receive the URL to access this online event,
e-mail: Laura Giardina: [email protected] or call (914) 241-0086 ext 20
HemoSense® will also be exhibiting at the American College of Cardiology 57th AnnualScientific Session, beginning March 29 in Chicago; Booth # 9063
About HemoSense
HemoSense Inc., a subsidiary of Inverness Medical Innovations, Inc. (AMEX: IMA), is a point-of-care diagnostic healthcare company that manufactures and commercializes easy-to-use, handheld blood coagulation systems for monitoring patients taking warfarin. The HemoSense INRatio® system, used by healthcare professionals and patients themselves, consists of a small monitor and disposable test strips. It provides accurate and convenient measurement of blood clotting time, or PT/INR values. Routine measurements of PT/INR are necessary for the safe and effective management of the patient’s warfarin dosing. INRatio is sold in the United States and internationally.
About Inverness
By developing new capabilities in near-patient diagnosis, monitoring and health management, Inverness Medical Innovations enables individuals to take charge of improving their health and quality of life. A global leader in rapid point-of-care diagnostics, Inverness’ products, as well as its new product development efforts, focus on infectious disease, cardiology, oncology, drugs of abuse and women’s health. Inverness is headquartered in Waltham, Massachusetts.
For more information about HemoSense and Inverness Medical Innovations, please visit www.hemosense.com and www.invernessmedical.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this press release regarding HemoSense’s business that are not historical facts may be “forward-looking statements” that involve risks and uncertainties. Specifically, the statements regarding the potential for wider use of patient self-testing for INR are forward looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management’s current, preliminary, expectations and are subject to risks and uncertainties which may cause the actual results to differ materially from the statements contained herein. Further information regarding the business of HemoSense and Inverness and risk factors relating to those businesses are detailed in Inverness’ filings with the Securities and Exchange Commission, including its 2007 Form 10-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date they are made. HemoSense and Inverness undertake no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
HemoSense(R) and INRatio(R) are registered trademarks of HemoSense, Inc.
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