HCFA Announces Coverage of Meridian Diagnostics New Ulcer Test.CINCINNATI--(BW HealthWire)--Oct. 22, 1999-- Meridian Diagnostics, Inc., Cincinnati, Ohio, (Nasdaq:KITS) today reported that the United States Health Care Financing Administration Health Care Financing Administration, n.pr department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies. (HCFA HCFA abbr. Health Care Financing Administration HCFA, n.pr See Health Care Financing Administration. ) has announced their national coverage policy decision relating to Meridian Diagnostics' new non-invasive ulcer test, Premier Platinum HpSA(TM)(HpSA). The purpose of the HpSA test, which was cleared by the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to market in May 1998, is to aid in the diagnosis of H. pylori infection. In December 1998, the HpSA test received additional clearances from the FDA to monitor therapeutic response in patients during and post therapy. The Premier Platinum HpSA test, which was assigned a separate CPT CPT See: Carriage Paid To code of 87338 by the American Medical Association American Medical Association (AMA), professional physicians' organization (founded 1847). Its goals are to protect the interests of American physicians, advance public health, and support the growth of medical science. , will become active in the January 2000 Medicare Fee Schedule. After HCFA's analysis of the medical evidence submitted by Meridian Diagnostics, including recent peer-reviewed publications, HCFA indicated that the new non-invasive HpSA test has a potential and vital role in the daily management of patients with Peptic Ulcer Disease Peptic ulcer disease (PUD) A stomach disorder marked by corrosion of the stomach lining due to the acid in the digestive juices. Mentioned in: Indigestion peptic ulcer disease See Duodenal ulcer, Gastric ulcer, GERD. (PUD PUD abbr. peptic ulcer disease Peptic ulcer disease (PUD) A stomach disorder marked by corrosion of the stomach lining due to the acid in the digestive juices. ) and those with suspected and/or documented H. pylori infection. Further indication is stated in HCFA's Decision of Record memorandum: "Non-invasive H. pylori testing has a well-circumscribed role (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation [1997]) in the evaluation of patients who present with signs and symptoms most suggestive for gastric/duodenal ulcers; follow resection of early gastric cancer; and have low-grade gastric MALT lymphoma." HCFA continues by saying, "Therefore, it should be deemed "reasonable and necessary" to enable providers to both diagnose and monitor eradication of H. pylori." HCFA has elected to allow for local contractor discretion as the "optimal solution" in the administration of coverage requests for Premier Platinum HpSA. For additional information on this memorandum, please log onto HCFA's website at www.HCFA.gov. For further product information on Premier Platinum HpSA, please send electronic mail requests to MDIkits@meridiandiagnostics.com. Meridian Diagnostics, Inc. is a fully integrated medical diagnostic company that develops, manufactures and markets a broad range of innovative diagnostic test kits, purified reagents and related products. Utilizing a variety of technologies, these products provide accuracy, simplicity and speed, and enable early diagnosis and treatment of common medical conditions such as gastrointestinal, viral, urinary tract, sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely , and respiratory infections. All of the Company's products are designed to enhance patient well-being while reducing total outcome costs of healthcare. Meridian has strong market positions in the areas of fungal disease diagnosis, Epstein-Barr Virus, parasitology, gastrointestinal infections, and upper respiratory conditions. All Meridian products are used outside of the human body and require little or no special equipment. The Company markets its products to hospitals, reference laboratories, and physician offices in more than 60 countries around the world. The Company's shares are traded through NASDAQ National Market, symbol KITS. Meridian Diagnostics' website address is www.meridiandiagnostics.com. |
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