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Biotech / Medical : Chromatics Color Sciences International. Inc; CCSI -- Ignore unavailable to you. Want to Upgrade?

To: JanyBlueEyes who wrote (3434)	6/23/1998 10:12:00 PM
From: JanyBlueEyes	Read Replies (1) \| Respond to of 5736

Chromatics Color Sciences Reaffirms American Medical Association's Confirmation of CPT Code NEW YORK, June 23 /PRNewswire/ -- CHROMATICS COLOR SCIENCES INTERNATIONAL, INC. (Nasdaq: CCSI - news) today reaffirmed that on February 17, 1998 the Company's regulatory consultant on third party reimbursement, Health Systems Concepts, received a letter from the American Medical Association (in response to its inquiries regarding the applicable CPT Code for the neonate bilirubin test performed by the Company's device) confirming that the applicable CPT Code would be 82250 Bilirubin, Total or Direct. The Company is responding to the allegations made by Asensio & Co. regarding the Colormate(TM) TLc-BiliTest(TM). Further, a report to the Company by Health Systems Concepts states that ''the AMA CPT Information Services confirmed that CPT Code 82250 Total Bilirubin is the correct code for reporting a bilirubin test. Use of this code is not based on the device type or place of service (Lab vs. point of care). Code use is based on whether the determination of Total Bilirubin is quantitative; if it is a quantitative assay the correct Code is 82250 Bilirubin, Total or Direct.'' The CPT Code is the Code necessary to permit third party insurance reimbursement of the bilirubin test provided by the Company's device. The Company's clearance letter from the Food and Drug Administration allows the Intended Use of the Colormate device ''to provide a numerical index of predicted serum bilirubin count in mg/dl that has been shown to correlate with Total serum Bilirubin concentration within a clinically useful range,'' which is a quantitative assay and further ''falls within the classification of 21 CFR 862.1113 Bilirubin (total and unbound) in the neonate test system.'' Darby Macfarlane, Chief Executive Officer of Chromatics, stated ''the Company is unaware of any change regarding this confirmation by the AMA and is currently reviewing its legal remedies regarding these and other allegations by Asensio & Co.'' Chromatics Color Sciences is in the business of color science..... Other medical applications will require additional clinical trials and FDA clearance........ Certain of the matters discussed in this announcement contain forward- looking statements......