Five Companies Publish Consultant Names and Payments in Industry-DOJ Agreement – Physicians with Company Ties Must Tell Patients

In the Loupe The hinge technique effectively prevents procedure-related morbidity and subsequent surgical bone replacement necessitated by traditional decompressive craniotomy. To create a “hinge” on the bone flap, a Y-shaped plate is secured loosely to the surrounding bone (white arrow). Two additional straight plates (red arrows) secured to the flap prevent future bone flap subsidence. For more information, see Schmidt JH, Reyes BJ, Fischer R, Flaherty, SK: Use of hinge craniotomy for cerebral decompression. J Neurosurg 107: 678-681, 2007.

Five companies, Biomet, DePuy, Smith & Nephew, Stryker and Zimmer, have prominently published on their Web sites the names of their consultants and the fees that they pay them. The disclosure of consultant payments was among the terms of deferred prosecution agreements and a nonprosecution agreement (Stryker) between the respective companies and the Department of Justice. The agreements also require the physician consultants to disclose their financial engagements with any company to their patients. In addition, a federal monitor at each company will review compliance with the agreements as well as all new and existing consulting relationships with the companies, and each company will assess reasonable needs for educational consulting services and new product-development consultants, among other requirements. The DOJ noted that many of the requirements in the agreements are based on those developed by Zimmer for its current Corporate Compliance Program. The companies were investigated for using consulting agreements with orthopedic surgeons as inducements to use a particular company’s artificial hip and knee reconstruction and replacement products. According to the DOJ, the financial inducements in the form of consulting agreements were entered into with hundreds of surgeons throughout the 2002-2006 time frame. The investigation revealed instances in which physicians did little or no work for the financial inducements but did agree to exclusively use the paying company’s products. The physician consultants also failed to disclose the existence of their relationships with the companies to the hospitals where the surgeries were performed and to the patients that they treated. https://newark.fbi.gov/dojpressrel/2007/nk092707.htm.

Get in the Loupe Compelling digital photos that depict a contemporary event or clinical topic or technique in neurosurgery are sought for In the Loupe. Submit a low resolution image in JPG format to [email protected] with “In the Loupe” in the subject line and a brief description of the photo and its significance in the e-mail message. Submitters must verify copyright ownership of the image and have a 300 DPI resolution image available for publication.

CMS Won’t Pay for Some “Never Events” in 2008
In August the Centers for Medicare and Medicaid Services issued a final rule that included nonpayment for some “never events.” According to American Medical News, in fiscal 2008 Medicare will not pay the added costs associated with objects left behind in surgery, air embolisms, delivery of incompatible blood or blood products, patient falls in the hospital, decubitus ulcers not present on admission, catheter-associated urinary tract infections, vascular catheter-associated infections, and mediastinitis after coronary artery bypass graft surgeries. It further reported that Medicare will propose adding six more conditions to this list in fiscal 2009.

Genetic Makeup May Influence Patient Response to Warfarin, Says FDA
In August the FDA approved updated labeling that includes pharmacogenomics in the prescribing information for warfarin. The information explains that people with variations in two genes, CYP2C9 and VKORC1, may need lower warfarin doses than people without these genetic variations. The CYP2C9 gene is involved in the breakdown (metabolism) of warfarin, and the VKORC1 gene helps regulate the ability of warfarin to prevent blood from clotting. The dosage and administration of warfarin must be individualized for each patient according to the particular patient’s prothrombin time/International Normalized Ratio (PT/INR) response to the drug. The specific dose recommendations are described in the warfarin product labeling, along with the new information regarding the impact of genetic information upon the initial dose and the response to warfarin. Ongoing warfarin therapy should be guided by continued INR monitoring.

The warfarin safety alert is posted in its entirety at www.fda.gov/medwatch. MedWatch offers a listserve, RSS news feeds and podcasts. The FDA also makes free, updated prescription drug labels available to physicians at https://dailymed.nlm.nih.gov.

CMS Selects Neurosurgeons for MedCAC
John A. Wilson, MD, and Andrew E. Sloan, MD, were selected in September to serve on the Medicare Evidence Development and Coverage Advisory Committee. They are among the pool of approximately 100 experts from which 15 or so are chosen as panelists for each MedCAC meeting. The MedCAC’s purpose is to provide unbiased and current deliberation of “state of the art” technology and science. https://www.cms.hhs.gov/FACA/02_MedCAC.asp

Study Suggests P4P Doesn’t Improve Patient Outcomes
A study of a pay-for-performance program for diabetes care showed that doctors complied with testing guidelines but patient outcomes did not improve. Coleman and colleagues looked at changes in physician practice patterns after the physicians started receiving bonus payments, on top of a base salary, for testing for hemoglobin A1c. The study is published in the November issue of the Journal of Health Care for the Poor and Underserved.

Teamwork Breakdowns Result in Errors by Residents
A recent study of closed malpractice claims in which errors by residents caused patients harm revealed that errors in judgment, teamwork breakdowns, and lack of technical competence were the most prevalent contributing factors. Lack of supervision and handoff problems were the most prevalent types of teamwork problems, and both were disproportionately more common among those errors that involved trainees than those that did not. Diagnostic decision-making and monitoring of the patient or situation were the most common tasks during which failures of technical competence occurred. Singh and colleagues studied errors that occurred between 1979 and 2001 with claims closed between 1984 and 2004. Specialist physicians reviewed random samples of closed malpractice claim files at five liability insurers and determined whether injuries had occurred and, if so, whether they were due to error. The study is published in the Oct. 22 issue of the Archives of Internal Medicine.

]]>