Physicians as Consultants Compliance Insights Into the 医生为顾问，依从性的见解.pptVIP

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2018-04-13 发布于江西
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Physicians as Consultants Compliance Insights Into the 医生为顾问，依从性的见解.ppt

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Physicians as Consultants Compliance Insights Into the 医生为顾问，依从性的见解.ppt

Contracts With Doctors:Not Just a U.S. Compliance Issue Anymore U.S. Hip and Knee Industry 5 companies (Zimmer, DePuy, Biomet, Smith Nephew and Stryker) account for nearly 95% of market More than 700,000 total hip and knee replacement surgeries performed in U.S. each year (HHS) Approximately 2/3 of implant patients are Medicare beneficiaries Physicians control selection of devices, but typically do not bear the cost Role of Surgeon Consultants Product Design Product Evaluation Surgeon Education and Training Sales Force Education Research The Investigation Commencement: Grand jury subpoenas issued to five largest orthopedics companies in late March 2005 by the U.S. DOJ through the U.S. Attorney’s Office for the District of New Jersey (USAO) The Focus: Consulting agreements with, and payments to, orthopedic surgeons Duration: Two-and-a-half years The Allegations According to the Office of Inspector General – From 2002-2006, 4 manufacturers paid over $800 million under 6,500 physician consulting agreements Vague descriptions of services rendered, sometimes drafted by sales reps $5,000 per quarter for reports on market trends, OR activity and product issues that were “cursory…often duplicated from quarter to quarter” and “of little or no value” Panel presentations at resorts; $5,000 for a 10 minute presentation Training for experienced sales reps; full day billed for 1-2 hour sessions Product design teams with up to 20 physicians, some added after project more than halfway completed The Resolution Criminal Complaints: Filed against 4 of the 5 companies, alleging conspiracy to violate the federal anti-kickback statute, in violation of 18 U.S.C. § 371 Alleged conduct: “[E]ntering into financial arrangements with orthopedic surgeons who were offered or who solicited payments from [Company], in part, for the surgeons’ use of [Company’s] hip and knee joint reconstruction and replacement products,” from in or about January 2002 to in or about December 2