Centers for Medicare and Medicaid Services Initiates Review for Expanded Reimbursement Coverage of Vasomedical's EECP® Therapy
CMS Requests Public Comments as the First Step of the Review Process
WESTBURY, N.Y., Jun 22, 2005 -- Vasomedical, Inc. (NASDAQ SC: VASO), a leader in the noninvasive treatment and management of cardiovascular diseases, has been notified by the Centers for Medicare and Medicaid Services (CMS) that the application requesting consideration for expansion of the national coverage for EECP® therapy has been accepted. The company currently markets the therapy for chronic stable angina and congestive heart failure and has been actively working to expand Medicare reimbursement coverage for less severe angina and to include coverage for congestive heart failure as a primary indication.
"We are pleased that CMS has accepted our application and begun the process for consideration of the national coverage determination. We will continue our efforts to provide the clinical evidence and support of this noninvasive option for treating cardiovascular diseases," said Thomas Glover, president and chief executive officer of Vasomedical. "Significant benefits of EECP therapy for treating angina and congestive heart failure including improvements in the ability to exercise, reduction in symptoms and improved quality of life have been reported in numerous studies including the most recent PEECH trial results," he added.
CMS has started a public comment period requesting feedback on the clinical evidence evaluating the health outcomes of ECCP therapy for Class II angina as listed in the request as well as the evidence submitted for EECP therapy for patients with NYHA Class II/III stable heart failure. This public comment period is open until July 20, 2005. A proposed coverage decision memo date is scheduled for December 20, 2005. Additional information is available at the CMS website: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=162
About EECP® Therapy
EECP® external counterpulsation therapy is typically given in 35 one-hour-sessions over seven weeks. Patients lie down on a padded table and their calves, lower thighs and upper thighs are wrapped in a cuff set. The system, which is synchronized to the individual patient's cardiac cycle, inflates the cuffs with air to create external pressure when the heart is resting and deflates the cuffs just before the heart beats. The system's action, which pulses counter to the heart's beating, increases blood flow to the heart muscle and decreases the heart's workload, creating a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen.
About Vasomedical, Inc.
Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP® external counterpulsation systems based on the Company's proprietary technology. EECP® therapy is a noninvasive, outpatient therapy for the treatment of diseases of the cardiovascular system currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and congestive heart failure. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function. The Company provides hospitals, clinics and private practices with EECP® equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient outcomes. Additional information is available on the Company's website at www.vasomedical.com.
EECP is a registered trademark for Vasomedical's enhanced external counterpulsation systems.
Except for historical information contained in this release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this report, words such as "anticipated," "believes," "could," "estimates," "expects," "may," "plans," "potential" and "intends" and similar expressions, as they relate to the Company or its management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of the Company's management, as well as assumptions made by and information currently available to the Company's management. Among the factors that could cause actual results to differ materially are the following: the effect of the dramatic changes taking place in the healthcare environment; the impact of competitive procedures and products and their pricing; medical insurance reimbursement policies; unexpected manufacturing or supplier problems; unforeseen difficulties and delays in product development programs; the actions of regulatory authorities and third-party payers in the United States and overseas; uncertainties about the acceptance of a novel therapeutic modality by the medical community; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to update forward-looking statements as a result of future events or developments.
SOURCE: Vasomedical, Inc. |
