Surgery News - October 2007 - (Page 3)

OCTOBER 2007 • SURGERY NEWS NEWS Stark III clarifies that physicians who administer pharmaceuticals under Medicare Part B (or who prescribe physical therapy, occupational therapy, and speech-language pathology, are entitled to get direct productivity credit for those orders, said Mr. Melvin. The clarification applies to those two ancillary services only, not to radiology or laboratories, or other services typically offered in-house, he said. CMS also lifted the prohibition on noncompete agreements. Under Stark II, practices could not impose noncompete agreements on physician recruits. Now, practices can bar competition for up to 2 years, but it’s not clear how far, geographically, that noncompete can extend, said Mr. Melvin. With the new rule, practices have to “go back and look at everything,” including how their physicians are being compensated and the arrangements the practice may have for equipment and leasing or services with hospitals or other DHS entities, he said. The final Stark rule goes into effect on December 5, 2007. ■ mately survived would have died,” he said. Dr. John Armstrong, who commented on the study, said that although the context for the performance of EDT in penetrating trauma is often bleak, it is not hopeless. “At a time when the pendulum has swung away from the performance of EDT in general, this study reemphasizes the importance of patient physiology in the field as a guide for the decision to perform EDT in penetrating trauma, regardless of the number of wounds and initial ED presentation,” said Dr. Armstrong, an ACS Fellow with the University of Florida. “Our study suggests that EDT is a technique that should be used for patients presenting in extremis after penetrating injury, despite the absence of many traditional survival predictors,” said Dr. Seamon. “However, even in an urban trauma center, where nearly all patients are brought from neighboring streets, EDT is futile in patients presenting without field signs of life.” ■ Self-Referral Policy • from page 1 physicians were considered to be individuals, outside of their practices. Exceptions to the law were evaluated using an indirect compensation analysis, which ended up being onerous and was the subject of many complaints to CMS. In comments on Stark II, physician groups, hospitals, and other facilities (called designated health services, or DHS entities under the Stark law) urged CMS to revert to the old policy. CMS itself came to see the indirect compensation analysis as a loophole that allowed potentially questionable investment arrangements to slip through, said Mr. Melvin. In the Stark III rule, CMS wrote that the change in policy means that, “many compensation arrangements that were analyzed under Phase II as indirect compensation arrangements are now analyzed as direct compensation arrangements that must comply with an applicable exception for direct compensation arrangements.” Epoetin Produces Mixed Results in Trauma Patients 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 Predictors Thoracotomy • from page 1 signs of life, 78% presenting with salvageable cardiac rhythms, and 65% showing normal ED vital signs. However, many survivors had clinical characteristics not normally associated with survival, he said. Overall, 10% of patients with gunshot wounds and 7% with multiple gunshot wounds survived. Additionally, 6% of patients without measurable vital signs, 5% of patients without ED signs of life, and 7% of patients whose cardiac rhythms were documented as nonsalvageable survived. In all, 30% of the survivors lacked three of the six positive predictors of survival, and one survivor lacked all the predictors, Dr. Seamon said. “Had a strict policy of EDT performance based solely on the presence of six survival predictors been followed, and EDT withheld, many patients who ulti- reatment with epoetin alfa reduced mortality but not the need for red cell transfusions in a prospective, randomized study of 1,460 critically ill surgical, medical, or trauma patients admitted to intensive care units. Patients who had weekly injections of epoetin alfa for up to 3 weeks were no less likely to receive a red cell transfusion than those given placebo, but were at an increased risk of thrombotic events. Treatment was associated with lower mortality, particularly among trauma patients, reported Dr. Howard Corwin, of the Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and his associates (N. Engl. J. Med. 2007;357:965-76). Patients in the study were treated at 115 U.S. medical centers between December 2003 and June 2006. They received weekly subcutaneous injections of epoetin alfa (40,000 U) or placebo, weekly, for a maximum of 3 weeks. The injections started within 48 and 96 hours of admission to the ICU, and patients were followed for 140 days. Patients were age 18 years or older (mean age 50 years). The proportion of patients who received a red cell transfusion between days 1 and 29, the primary end point, was 46% among those who received epoetin and 48% among those who received placebo. The mean number of red cell units transfused per patient between days 1 and 42, a secondary end point, also was similar among those on epoetin (4.5 U) and those on placebo (4.3 U). At day 29, mortality in the overall population was significantly lower among those on epoetin (8.5%) than placebo (11.4%). Among trauma patients, mortality was 3.5% among those treated with epoetin and 6.6% with placebo, a significant difference. Mortality followed a sim- T ilar pattern at 140 days. The mortality difference was the most important finding, they said, noting that their earlier trial also showed reduced mortality among trauma patients with epoetin alfa. Among those on epoetin alfa, the incidence of thrombotic vascular events through 140 days was significantly higher among those with three doses of epoetin (almost 23%, compared with 16% for those with three placebo doses). The study hypothesis was that epoetin alfa would improve clinical outcomes by preventing adverse events with red blood cell transfusions, but “this was clearly not the case,” the authors said, and pointed out that mortality was reduced, despite the lack of an effect on transfusions. The nonhematopoietic effects of epoetin alfa offer “a more likely explanation” for the findings, which need to be investigated further, they said. “We believe that epoetin alfa could benefit trauma patients remaining in an ICU for more than 48 hours,” with hemoglobin concentrations under 12 g/dL and no history of thrombotic disease, and who meet other inclusion criteria of their study, but not in patients who have spent less than 48 hours in the ICU. In an editorial, Dr. Deborah Cook and Dr. Mark Crowther, of St. Joseph’s Healthcare, McMaster University, Hamilton, Ont., said it was “tantalizing but premature” to suggest erythropoietin could save trauma patients. The absolute difference in the number of trauma patients who died by day 29 and 140 was small, and “insufficient to provide support for the routine use of erythropoetin,” (N. Engl. J. Med. 2007;357:1037-9). Four authors were from Johnson & Johnson Pharmaceutical Research and Development, which sponsored the study. Johnson & Johnson is the parent of Ortho Biotech, manufacturer of Procrit, the brand of epoetin alfa used. ■ 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 James W. Jones, M.D., Ph.D., FACS, Ethics, Texas Natalie C. Kerr, M.D., FACS, Ophthalmology, Tennessee William M. Kuzon, Jr., M.D., Ph.D., FACS, Plastic Surgery, Michigan Robert Madoff, M.D., FACS, Colorectal Surgery, Minnesota James Markmann, M.D., FACS, Transplantation, Pennsylvania Jack W. McAninch, M.D., FACS, Urology, California Robert Morell, M.D., Anesthesiology, Florida 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 Mark Weissler, M.D., FACS, Otolaryngology, North Carolina 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 International Medical 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 Society News Group, a division of 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. 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Surgery News - October 2007

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