Centers for Medicare and Medicaid Services (CMS) Publishes Proposal to Keep Existing Coverage with No Changes for Expansion of National Coverage of EECP Therapy.WESTBURY, N.Y. -- Vasomedical is Committed to Continue to Work with 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. to Secure Expanded Coverage; Conference Call to Begin Today at 3:00 PM EST EST electroshock therapy. EST abbr. electroshock therapy 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) has published a proposal to keep existing coverage with no changes for expansion of external counterpulsation therapy. Current coverage is limited to 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 Class (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/IV refractory angina deemed not amenable to revascularization. Vasomedical had made a formal request for a revision of Medicare reimbursement coverage to expand existing coverage for angina to include less severe angina and to add 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. as a primary indication. In its announcement, CMS states, "CMS posts a proposed decision memorandum to keep the existing coverage for external counterpulsation therapy with no changes for expansion for the additional cardiac conditions requested." In their proposed decision memorandum, they further stated, "The Centers for Medicare and Medicaid Services (CMS) is seeking public comment on the proposed determination that the evidence is not adequate to conclude that external counterpulsation therapy is reasonable and necessary for Canadian Cardiovascular Society Classification (CCSC) II angina and NYHA NYHA New York Heart Association Class II/III stable heart failure with ejection fraction ejection fraction n. The blood present in the ventricle at the end of diastole and expelled during the contraction of the heart. Ejection fraction less than or equal to 35%." Vasomedical is fully committed to work closely with CMS to resolve all issues and secure expanded coverage. With clinical evidence in more than 50 peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. articles, including data from randomized controlled trials documenting the clinically significant and life enhancing benefits of EECP EECP® Enhanced external counterpulsation, see there (R) therapy for patients suffering from angina and congestive heart failure, including symptom relief, increase in functional capacity and improved quality of life, we believe the threshold for clinical evidence required by CMS has been met. "We are disappointed by the proposed CMS decision not to expand reimbursement coverage of EECP therapy. We believe the breadth and quality of clinical evidence supporting the use of EECP therapy in patients with congestive heart failure, including the most recent PEECH PEECH Prospective Evaluation of EECP in Congestive Heart Failure trial results, especially in patients aged 65 and older, clearly demonstrates the significant benefits including improvements in the ability to exercise, reduction in symptoms and improved quality of life," said Thomas Glover, president and chief executive officer of Vasomedical. "As the market leader in EECP therapy, we are strongly committed to this treatment. This is an important therapy for the thousands of patients who find inadequate relief from drugs and who are not candidates for further invasive procedures." 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. CMS will accept public comments on its proposed decision from December 19, 2005 to January 19, 2006 and will then issue a final decision memorandum. The final decision is anticipated for March 20, 2006. Vasomedical strongly urges the public including EECP providers and patients to take advantage of this opportunity to share their experiences with EECP therapy to CMS during this public comment period. Additional information is available at the CMS website: http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=162. Conference call Management will hold a conference call today at 3:00 PM EST to discuss this announcement. To participate in the live call by telephone, please dial (800) 639-0297 from the U.S., or for international callers, please dial (706) 634-7417. A telephone replay will be available until 11:59 p.m. Eastern Time on December 22, 2005, by dialing (800) 642-1687 from the U.S. or (706) 645-9291 for international callers and entering pass code 3745437. 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" 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. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion