Food & Drug Regulation

Corporate Integrity Agreements and Corporate Compliance Programs

Presented by Lynn Shapiro Snyder, Constance Wilkinson
Recorded On: Tuesday, September 25, 2012
Duration: 90 minutes
Arrow Down ONLINE

Arrow Down PHONE /FAX
By Phone: 1-800-677-3789

In a little-noticed decision, the Office of the Inspector General of the Department of Health and Human Services (OIG) forced a company that violated its corporate integrity agreement (CIA) to divest a subsidiary as a condition for the parent to avoid exclusion from federal health care programs. Not only is forced divestiture a relatively new enforcement approach for the OIG, this appears to be the first time the OIG has used forced divestiture as a sanction for violations of a CIA. The move signals the OIG’s continuing willingness to achieve program compliance through novel uses of its enforcement authority.

Register today for this 90-minute webinar to learn the common elements between effective corporate compliance programs and corporate integrity agreements (CIAs) entered into with the DHHS Office of the Inspector General and how developments in CIAs may form compliance program structure and elements.

Our experts, Lynn Shapiro Snyder and Constance Wilkinson of Epstein Becker Green will provide specific provisions in current CIAs with biopharmaceutical, pharmaceutical and medical device companies and discuss the recent OIG Report on compliance measures that companies currently under CIAs find effective. You will learn how your company can improve its readiness should a CIA become necessary.

Key Takeaways:

  • What are the similarities and differences between effective corporate compliance programs and corporate integrity agreements? 
  • Are there provisions in a CIA that may be subject to negotiation? If so, which ones?
  • What are the most significant new provisions in the most recent CIAs, such as that of GlaxoSmithKline?
  • What are some of the key provisions where the CIA dictates additional or enhanced requirements for the organization and operation of the company's compliance program and which of those key provisions may it be beneficial to retain in place once the CIA expires? (Includes a discussion of the key findings from the DHHS OIG's Report from the February 23, 2012 Pharmaceutical Compliance Roundtable.)
  • What are the more challenging sections of an effective compliance program and what can companies do to minimize the risks and maximize compliance in those areas?
  • What are the more challenging provisions in the CIAs and what can companies do to minimize the risks and maximize compliance in those areas?

Register today to receive answers to these key questions and improve your readiness to implement a CIA if necessary or to strengthen your compliance program to reduce that risk.

Lynn Shapiro Snyder

Lynn Shapiro Snyder is a Senior Member of the Firm in the Health Care and Life Sciences and Litigation practices in the firm's Washington, DC, office, and she is Strategic Counsel with EBG Advisors, Inc. Ms. Snyder has over thirty years of experience at Epstein Becker Green, advising clients about federal, state, and international health law issues, including Medicare, Medicaid, TRICARE, compliance, and managed care issues. Her clients include health care providers, payors, pharmaceutical/device manufacturers, and those companies and financial services firms that support the health care industry. She is a frequent speaker and publishes extensively.

Modern Healthcare magazine named Ms. Snyder as one of the "100 Most Powerful People in Healthcare" in its inaugural list, in August 2002. In April 2005, Modern Healthcare magazine named Ms. Snyder as one of the "Top 25 Women in Healthcare." In the May 2006 issue of Nightingale's Healthcare News, Ms. Snyder was named one of the "Outstanding Fraud & Compliance Lawyers for 2006." Over the years, Ms. Snyder has been recognized in The Best Lawyers in America, Super Lawyers, and Chambers USA. In 2007, Ms. Snyder was presented with the 2007 Women to Watch Award by the Jewish Women International. She also has been quoted in The New York Times and other leading publications.

Ms. Snyder serves on the firm's Board and Finance Committee. The firm's Health Care and Life Sciences practice is one of the largest health law practices in the United States. She is Chair of the Third-Party Payment Practice Group, which concentrates on legal and regulatory matters arising under third-party payment programs such as Medicare, Medicaid, and TRICARE. Ms. Snyder co-chairs the Health Care Fraud Practice Group that focuses on federal and state fraud issues, including anti-kickback, self-referral, false claims, secondary payor issues, and false billings. She also co-chairs the Health And Employment Law (HEAL) Group, leading the Health Care and Life Sciences practice in its partnership with the firm's national Labor and Employment practice. She also contributes to the HEAL blog. Ms. Snyder also works on matters in the Pharmaceutical Industry Health Regulatory Practice Group and the Managed Care/Integrated Delivery System Practice Group.

Constance Wilkinson
Constance A. Wilkinson is a Member of the Firm in the Litigation and Health Care and Life Sciences Practices in the EpsteinBeckerGreen Washington, DC office, with a primary focus on federal health care contracting.

Ms. Wilkinson has significant experience with audits of fee-for-service and managed care contractors participating in the Federal Employee Health Benefits Program (FEHBP), pharmaceutical pricing and procurement and health care quality improvement activities and external review, including conflict of interest issues.

Ms. Wilkinson has made numerous presentations to government and industry groups and has served on the faculty of the Government Contracts Program of the National Law Center at The George Washington University. She has co-authored several articles and publications including Public Official's Guide to E-Government (Thompson Publishing Group 2001) and materials on trade secrets.

Ms. Wilkinson is an active supporter of local and national organizations dedicated to providing legal counsel and business training to entrepreneurs and small businesses. Since 1992, through organizations such as the American Women's Economic Development Corporation, she has counseled individuals and developed and conducted seminars concerning topics pertinent to forming and managing a business and creating a government contract. She previously provided counseling and presentations on similar subjects through the Small Business Administration's SCORE Program.
Ms. Wilkinson—a native Washingtonian—joined the firm in 1986. In her spare time, she coordinates project development and planning for educational projects in El Salvador and provides assistance to the Due Process of Law Foundation on human rights issues in Central America.