Surgery News - August 2007 - (Page 2)

NEWS SURGERY NEWS • A U G U S T 2 0 0 7 FDA Reports Propofol-Related Febrile Reactions B Y E L I Z A B E T H M E C H C AT I E Else vier Global Medical Ne ws he Food and Drug Administration has issued an alert about patients who developed chills, fever, and body aches shortly after receiving propofol and is advising health care professionals who observe similar reactions to evaluate these patients for bacterial sepsis. Professionals who use propofol products should carefully adhere to the recommendations for handling them, which include limiting the use of one vial or prefilled syringe to one patient, and starting to administer the drug immediately after opening the vial or syringe. The alert said that there have been “sev- T eral clusters” of patients who have experienced these symptoms shortly after receiving propofol. All of the cases have been in patients who received sedation in gastroenterology suites, but the alert is aimed at all health care professionals who use propofol for either sedation or general anesthesia. In some facilities, a single vial was used for more than one patient, according to the FDA. To date, testing of units of propofol vials and lots used for these patients have not identified any vials contaminated with bacteria or endotoxins, and there is no evidence that the patients had bacterial sepsis. Propofol is available in a trade formulation marketed as Diprivan and as generic products. The vials and prefilled syringes contain an antimicrobial additive, but the products “can still support the growth of microorganisms,” according to the FDA. The alert says that these cases are similar to reports received by the FDA after propofol first became available in the United States, when there was no antimicrobial agent added to the formulation. But these reports dropped substantially after an antimicrobial agent was added to the vials and pre-filled syringes. The reports to date have come from two facilities in Pennsylvania, one in New Jersey, two in New York, and two in Tennessee. In all cases, symptoms began 6-18 hours after propofol was administered and lasted up to 3 days. Several of these pa- tients were hospitalized and one patient had a seizure, but in all cases the patients have recovered “without apparent sequelae,” according to the FDA. The Centers for Disease Control and Prevention is investigating the outbreak by visiting these sites and evaluating patients for other possible causes of symptoms. ■ More information is available at: www.fda.gov/medwatch/safety/2007/safety 07.htm#Diprivan. The FDA is asking health care professionals to report cases of patients who develop fever, chills, body aches or other symptoms of an acute febrile reaction after receiving propofol to MedWatch, the agency’s adverse event reporting program, at 800-3321088 or www.fda.gov/medwatch. Payment Adjustments ASC Procedures • from page 1 It requires systemic thrombolysis. It can be reported only with an unlisted code. The change means that more patients will likely be able to have procedures done in an ASC, said Dr. Mabry, who is also a shareholder in an ambulatory surgery center in Pine Bluff, Ark., and an ACS Fellow. The question now: “Is the payment rate the right rate?” he said. (See box.) CMS also decided to limit payment for procedures performed in an ASC that are done in a physician’s office more than half the time. “CMS does not want to create inappropriate payment incentives for procedures to be performed in ASCs if the physician’s office is the most efficient setting for providing high quality care,” according to the agency. FASA, the advocacy arm of the Foundation for Ambulatory Surgery in America, objected to this proposal and also to CMS’s list of exclusions, arguing that the agency should pay for any procedure that is not covered under the inpatient system. Under the new rule, Medicare will make separate payments for ancillary services, such as radiology, and for some drugs and biologicals considered integral to a surgical procedure. The agency will also make adjustments for procedures that have high device costs (that is, when the cost of the device accounts for more than half the median cost of the procedure). Those high–device cost procedures include placement of neurostimulators, pulse generators, or pacemakers. The adjustment is already in effect under CMS’s hospital outpatient payment system. ■ Payment Proposals for 2008 to mula for ambulatory In additionhowsetting the forsurgery centers will be paid going forward, CMS has also issued proposals on how the formula will guide payments to ASCs in 2008, and on how much hospital outpatient departments will receive in 2008. In 2008, the federal health agency has proposed that ASCs would be paid at 65% of hospital outpatient rates, up from an earlier proposal of 62%. Medicare and Medicaid expect to pay $3 billion in 2008 to about 4,600 participating ASCs, according to CMS. In the proposed pay rates, orthopedic procedures would receive the greatest increases, whereas gastrointestinal procedures would be cut. An upper GI endoscopy with biopsy (CPT code 43239) would be cut by 13%, from $446 in 2007 to $387 in 2008. A small-bowel endoscopy with biopsy (CPT code 44361) would be cut by about 11%. The agency also issued its proposal for hospital outpatient payments, which is partially driven by the desire to keep beneficiary copays at 20%. In 2008, the overall copay will be about 26%, but for most procedures, beneficiaries will be liable for only 20%. Hospitals will receive $35 billion under the proposed rule in 2008, about a 10% increase over 2007. Procedures involving the implantation of cardiac devices are mostly slated for increases: from 5% for baremetal stents to 14% for drugeluting stents, and 3%-20% for defibrillators. Payment for the implantation of neurologic devices would also increase. Implantation of a neurostimulator would rise from $11,500 in 2007 to $12,500 in 2008. Hospitals will get an automatic 2% cut in fees in 2009 if they don’t report on 10 quality measures in 2008, including five measures on how well emergency departments handle myocardial infarction; two surgical care measures (the selection and timing of antibiotic prophylaxis); one heart failure measure (ACE inhibitor or angiotensin receptor blocker given); one on communityacquired pneumonia (empiric antibiotic); and a diabetes measure (poor hemoglobin A1c control). CMS is accepting comments on the 2008 proposals until midSeptember. The final regulations will be published in November. SURGERY NEWS SURGERY NEWS Editor in Chief, SURGERY NEWS Lazar J. Greenfield, M.D., FACS ACS Director of Communications Linn Meyer EDITORIAL ADVISORY BOARD Mark S. Allen, M.D., FACS, Cardiothoracic Surgery, Minnesota John H. Armstrong, M.D., FACS, Trauma and Mass Casualties, Florida Hunt Batjer, M.D., FACS, Neurological Surgery, Illinois Mark R. Belsky, M.D., FACS, Orthopedic Surgery, Massachusetts David G. Burris, M.D., FACS, Trauma and Uniformed Services, Maryland Gregory S. Cherr, M.D., ACS Resident/Associate Society, New York Fred A. Crawford, Jr., M.D., FACS, Cardiothoracic Surgery, South Carolina William J. Hoskins, M.D., FACS, Obstetrics and Gynecology, Georgia Natalie C. Kerr, M.D., FACS, Ophthalmology, Tennessee Robert Madoff, M.D., FACS, Colorectal Surgery, Minnesota William M. Kuzon, Jr., M.D., Ph.D., FACS, Plastic Surgery, Michigan James Markmann, M.D., FACS, Transplantation, Pennsylvania Jack W. McAninch, M.D., FACS, Urology, California James P. Neifeld, M.D., Surgical Oncology, Virginia Richard A. Prinz, M.D., FACS, Endocrine Surgery, Illinois David W. Rattner, M.D., FACS, Minimally Invasive Surgery, Massachusetts Thomas F. Tracy, Jr., M.D., FACS, Pediatric Surgery, Rhode Island Kevin K. Tremper, M.D., Ph.D., Anesthesiology, Michigan Patricia L. Turner, M.D., FACS, Information Technology, Maryland Thomas Wakefield, M.D., FACS, Vascular Surgery, Michigan Steven E. Wolf, M.D., FACS, Trauma (Burns and Mass Casualties), Texas SURGERY NEWS is the official newspaper of the American College of Surgeons and provides the practicing surgeon with timely and relevant news and commentary about clinical developments and about the impact of health care policy on the profession and on surgical practice today. Content for SURGERY NEWS is provided by the Elsevier Society News Group and Elsevier Global Medical News. Content for the NEWS FROM THE COLLEGE is provided by the American College of Surgeons. The ideas and opinions expressed in SURGERY NEWS do not necessarily reflect those of the College or the Publisher. The American College of Surgeons and Elsevier Inc. will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein. POSTMASTER: Send changes of address (with old mailing label) to Circulation, SURGERY NEWS, 60 B Columbia Rd., 2nd flr., Morristown, NJ 07960. The American College of Surgeons’ headquarters is located at 633 N. Saint Clair St., Chicago, IL 60611-3211. SURGERY NEWS (ISSN 1553-6785) is published monthly for the American College of Surgeons by Elsevier Inc., 60 Columbia Rd., Bldg. B, Morristown, NJ 07960; 973-290-8200; fax 973-290-8250. ELSEVIER SOCIETY NEWS GROUP President, IMNG Alan J. Imhoff Director, ESNG Mark Branca Executive Director, Editorial Mary Jo M. Dales Executive Editor, IMNG Denise Fulton Executive Editor, EGMN Kathy Scarbeck Publication Editor Elizabeth Wood Publication Associate Editor Jay C. Cherniak VP, Medical Education Sylvia H. Reitman Senior Director, Marketing and Research Janice Theobald Circulation Analyst Barbara Cavallaro Executive Director, Operations Jim Chicca Director, Production and Manufacturing Yvonne Evans Production Manager Judi Sheffer Art Director Louise A. Koenig National Account Manager Stephen H. Close, 973-290-8223, fax 973-290-8250, s.close@elsevier.com Classified Sales Manager Da http://www.fda.gov/medwatch/safety/2007/safety07.htm#Diprivan http://www.fda.gov/medwatch/safety/2007/safety07.htm#Diprivan http://www.fda.gov/medwatch

Table of Contents Feed for the Digital Edition of Surgery News - August 2007

Contents Drug Developments News From the College Thoracic Surgery Head & Neck Surgery

Surgery News - August 2007

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