Centers for Medicare and Medicaid Services Decides to Maintain Existing Reimbursement Coverage with No Changes for EECP Therapy; Heart Failure Patients With Very Few Options Denied Access to Therapy; Conference Call to Begin Today at 4:30 p.m. ET.WESTBURY, N.Y. -- Vasomedical, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on SC: VASO), a leader in the noninvasive treatment and management of cardiovascular diseases, today announces that the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and (CMS (1) See content management system and color management system. (2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system. ) has published a final decision to keep existing reimbursement coverage with no changes for expansion of coverage for external counterpulsation therapy. Reimbursement coverage is still provided for Medicare patients with Canadian Cardiovascular Society The Canadian Cardiovascular Society Angina Grading Scale is commonly used for the classification of severity of angina: Class I – Angina only during strenuous or prolonged physical activity Classification (CCSC CCSC Consortium for Computing in Small Colleges CCSC Cheung Chuk Shan College (Hong Kong) CCSC Chicagoland Construction Safety Council CCSC Cemetery Consumer Service Council CCSC Commercial Computer Security Centre ) III or IV refractory angina deemed not amenable to revascularization. CMS determined that the evidence is not adequate to conclude that external counterpulsation therapy is reasonable and necessary for the treatment of patients with CCSC II angina or New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of Heart Association (NYHA NYHA New York Heart Association ) class II or III heart failure. Additional details of the decision can be found on the CMS website at http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=162. "We are clearly disappointed by the CMS decision. We are particularly concerned for the heart failure patients with very few or no options who would benefit from EECP EECP® Enhanced external counterpulsation, see there (R) therapy if CMS had chosen to expand coverage at this time. Many patients have no options other than to suffer with their symptoms and live a low quality of life as a result. We believe the breadth and quality of clinical evidence supporting the use of EECP therapy in patients with congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , including the most recent results from the PEECH PEECH Prospective Evaluation of EECP in Congestive Heart Failure trial, especially in patients aged 65 and older, clearly demonstrates the significant benefits obtained by patients, including improvements in the ability to exercise, a reduction in symptoms and an improved quality of life," said Thomas Glover, president and chief executive officer of Vasomedical. "It is possible that CMS came to this conclusion because they could not put sufficient weight on the evidence from the PEECH trial as the results have yet to be published in a peer-reviewed publication. We expected the PEECH results would have been published at this point, largely based upon historical publication timeframes. Unfortunately, Vasomedical has no control over the timing of the publication. We will continue to work closely with CMS to determine what actions will be required once the trial results are published. However, there is no guarantee that publication of the PEECH manuscript or other recently developed information will provide sufficient evidence for CMS to expand coverage," added Thomas Glover. More than five million people in the United States suffer from congestive heart failure and with more than 550,000 new cases diagnosed annually, it is a growing epidemic. Heart failure is the number one diagnosis in Medicare patients and the leading cause of hospitalization in patients over the age of 65. This growing disease also places an enormous burden on the U.S. healthcare system, with an estimated economic impact ranging from $20 billion to more than $50 billion per year. Compounding the problem is that there are few consensus therapies to treat congestive heart failure beyond medical management and many patients are left to suffer with symptoms of shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. and fatigue. For patients who are good candidates for the treatment, EECP is a safe, low cost, noninvasive therapy. Conference call Management will hold a conference call today at 4:30 p.m. ET to discuss this announcement. To participate in the live call by telephone, please dial (866) 337-0069 from the U.S., or for international callers, please dial (706) 634-0745. A telephone replay will be available until 11:59 p.m. Eastern Time on March 23, 2006, by dialing (800) 642-1687 from the U.S. or (706) 645-9291 for international callers and entering the conference ID code, 6964618. Those interested in listening to the conference call live via the Internet may do so by visiting the Company's web site at www.vasomedical.com, under the investor relations Investor relations The process by which the corporation communicates with its investors. tab. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install the necessary audio software. The webcast will be archived for 30 days. About EECP(R) Therapy EECP external counterpulsation therapy is typically given in 35 one-hour sessions over seven weeks. Patients recline re·cline v. re·clined, re·clin·ing, re·clines v.tr. To cause to assume a leaning or prone position. v.intr. To lie back or down. on a contoured treatment table and their calves, lower thighs and upper thighs are wrapped in a pneumatic cuff set. The system, which is synchronized to the individual patient's cardiac cycle cardiac cycle n. A complete beat of the heart, including systole and diastole and the intervals between, beginning with any event in the heart's action to the moment when that same event is repeated. , inflates the cuffs with air to create external pressure when the heart is resting and deflates the cuffs just before the next heartbeat. The system's action, which pulses counter to the heart's beating, increases blood flow to the heart muscle and other organs and decreases the heart's workload, creating a greater oxygen supply for the heart muscle while lowering its 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 unique proprietary technology. EECP therapy is a noninvasive, outpatient therapy for the treatment of diseases of the cardiovascular system cardiovascular system: see circulatory system. cardiovascular system System of vessels that convey blood to and from tissues throughout the body, bringing nutrients and oxygen and removing wastes and carbon dioxide. currently indicated for use in cases of stable or unstable angina, congestive heart failure, acute myocardial infarction acute myocardial infarction ( EECP is a registered trademark for Vasomedical's enhanced external counterpulsation enhanced external counterpulsation Cardiology A nonsurgical treatment of angina pectoris and CAD which ↑ blood flow to the heart by compressing blood vessels in the lower extremities. See MUST-EECP. 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," "will" 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. |
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