July 12, 1999 11:06
Medicare Payment for Vasomedical's EECP Begins July 1, 1999
WESTBURY, NY--(BUSINESS WIRE)--July 12, 1999--
EECP is the only external counterpulsation system for which the clinical trials required for coverage have been conducted and published
Vasomedical, Inc. (Nasdaq: VASO) announced today that the Health Care
Financing Administration (HCFA), the federal agency that administers the Medicare program for more than 38 million beneficiaries, has communicated payment instructions for the EECP external counterpulsation therapy to its contractors around the country, stipulating coverage for services provided on or after July 1, 1999.
As specified in HCFA's previously issued coverage policy, the use of the EECP device is covered for patients with disabling angina pectoris who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to surgical interventions, such as balloon angioplasty and cardiac bypass. The new Current Procedural Terminology (CPT) code (93799) to be used to bill for EECP therapy is that which the American Medical Association (AMA) and the American College of Cardiology (ACC) have recommended.
HCFA has restricted coverage "to those enhanced external counterpulsation systems that have sufficiently demonstrated their medical effectiveness in treating patients with severe angina in well-designed clinical trials. Note that a 510(k) clearance by the Food and Drug Administration does not, by itself, satisfy this requirement." Vasomedical's EECP is the only such system to have undergone a rigorous test in a controlled, double-blinded, randomized, multicenter study. The results of this study were published in a peer-review journal, the Journal of the American College of Cardiology, in June 1999.
Anthony Viscusi, President and CEO of Vasomedical, stated that "the
Company is pleased with HCFA's review process and coverage decision. We have from the beginning been guided by the dictates of evidence-based medicine and have established standards of evidence that are difficult to match. It took us more than four full years to design and conduct our randomized, controlled, multicenter study of EECP (MUST-EECP) and have the results published in a peer-review medical journal." He added, "The scientific and responsible approach we have followed to confirm the angina pectoris indication is also the approach we have been following in our program to establish an FDA-approved claim for the use of EECP therapy in congestive heart failure."
In its program memorandum concerning coverage and billing criteria for EECP therapy, HCFA provides for its Medicare intermediaries and carriers to develop a local payment amount for the therapy. Based on a methodology recognized by AHA, as well as HCFA itself, Vasomedical has analyzed practice and professional expenses and determined a Medicare payment amount that the Company believes will make economic viability possible for treatment centers and expand patient access to EECP therapy. Vasomedical will provide assistance for appropriate payment determinations, taking general and local factors into account.
Vasomedical, Inc. (Nasdaq:VASO; www.vasomedical.com) is primarily
engaged in designing, manufacturing, marketing and supporting external
counterpulsation systems based on the Company's proprietary technology. EECP(R) is a registered trademark of Vasomedical. This system is now in use at major medical centers, including Columbia-Presbyterian Medical Center, the Mayo Clinic, the Miami Heart Institute and the Ochsner Foundation Hospital, as well as medical centers affiliated with the University of Pittsburgh, the University of California San Diego, the University of California San Francisco and the University of Virginia. The Company provides hospitals, clinics and private medical practices EECP(R) equipment, treatment guidance and a staff training and maintenance program to ensure optimal patient outcomes.
Except for the historical information contained in this news release, the matters discussed are forward-looking statements that involve risks and uncertainties. When used in this release, words such as "anticipate," "believe," "estimate," "expect," "intend," and similar expressions, as they relate to the company and 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 business and economic conditions; the impact of competitive products and pricing; capacity and supply constraints or difficulties; product development, commercialization or technological difficulties; the regulatory, reimbursement and trade environment; and the risk factors reported from time to time in the Company's SEC reports. The Company undertakes no obligation to update any forward-looking statements as a result of future events or developments.
|
