Gina Cavalier
is a partner in the FDA & Life Sciences Practice Group. She was recently named one of the nation's "Life Sciences Stars" by LMG Life Sciences and was recommended by Legal 500 for her work in the Life Sciences and Healthcare industries. She focuses her practice on health care fraud and abuse and compliance, and provides advice to a wide range of health care clients, including pharmaceutical and medical device manufacturers, DME suppliers, providers (e.g., hospitals, health systems, pharmacies and SNFs), health care industry trade associations, and group purchasing organizations.
In particular, Ms. Cavalier assists clients during fraud investigations and audits, and analyzes complex health care arrangements under the Anti-Kickback, Stark, Beneficiary Inducement and False Claims laws. She has handled a wide-range of government inquiries, negotiated settlements and corporate integrity agreements ("CIAs"), drafted numerous corporate compliance programs and counseled clients regarding the structure of joint ventures. She also has significant experience providing advice to pharmaceutical and medical device manufacturers, particularly related to sales and marketing practices and complex discounting arrangements, including bundling.
In addition, Ms. Cavalier is a Certified Information Privacy Professional ("CIPP"), a credential awarded by the International Association of Privacy Professionals that demonstrates expertise in privacy law. She has significant expertise in health care related privacy laws, principally the Health Insurance Portability and Accountability Act ("HIPAA"), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and related implementing regulations including the Privacy, Security, and Breach Notification Rules, as well as state law.
Recent Presentations and Publications
Speeches
“Fraud and Abuse: Legal Guidelines for Sales and Marketing,” AdvaMed Medical Device Reimbursement Workshop, Medical Technology Learning Institute (November 13, 2014)
“Discounts, Donations, Demos & More: Top Health Care Compliance Issues for Device Companies,” King & Spalding West Coast Medical Device Summit (September 2014)
“Legal Issues Impacting Pharmacy Hubs: Kickbacks and Patient and Privacy,” World Congress Patient Solution Services and Hub Design (August 19, 2014)
“Re-Think Risk Assessments to Enhance Compliance,” CBI 10th Annual Regulatory and Compliance Congress for Medical Device and Diagnostics (February 25, 2014)
Chief Compliance Officer Summit, CBI 10th Annual Regulatory and Compliance Congress for Medical Device and Diagnostics (February 25, 2014)
“HIPAA: A Compliance Roadmap”, George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 19, 2014)
“Business Associates, Breaches and Budgets: HIPAA/HITECH Priorities for Device Companies,” King & Spalding Medical Device Summit (October 2013)
“Keeping House: Key Areas for Compliance Risk Assessments for Device Manufacturers,” King & Spalding Medical Device Summit (October 2013)
“Global Sunshine: Transparency Trends and Requirements Outside the U.S.,” AdvaMed (June 11, 2013)
“Fraud and Abuse Risks for Medical Device Manufacturers in a New (and Changing) Environment,” Medical Device Summit, Med Tech Market Access (June 5, 2013)
“Hardening HIPAA/HITECH E-Security for Covered Entities and Business Associates: Risk Assessments, Compliance Priorities and Industry Standards,” King & Spalding Webinar (May 2013)
“Breaches, Business Associates and Beyond: What You Need to Know About the New HIPAA/HITECH Regulations,” Webinar (February 2013)
“HIPAA/HITECH and the Privacy, Security and Breach Notification Rules, George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 13, 2013)
“HIPAA/HITECH & Life Sciences Companies: Highlights and Important Implications,” CBI West Coast Compliance Congress (November 2012)
“Transparency Trends and Requirements Outside the U.S.,” AdvaMed Physician Payments Sunshine Act Seminar for Medical Devices (November 2012)
“HIPAA/HITECH: Direct and Indirect Implications for Device Companies,” King & Spalding West Coast Medical Device Summit (October 2012)
HIPAA and the HITECH Act: Privacy, Security and Breach Notification, George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 15, 2012)
“Bracing for Mandatory Federal Sunshine Reporting Requirements: Immediate Action Plans for 2012,” 4th Annual Pharmaceutical University, King & Spalding (November 2011)
"HIPAA 101: What You Need to Know," Reed Smith University (March 21, 2011)
"HIPAA and the HITECH Act: Privacy, Security and Breach Notification" George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 16, 2011)
"Hammer and Nails: Anti-Fraud Provisions in the PPACA - Navigating New Risks in the Wake of Health Care Reform," Reed Smith University (July 28, 2010)
"HIPAA and the HITECH Act: Privacy, Security and Breach Notification" George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 17, 2010)
"Federal False Claims Act: Overview of Amendments," Reed Smith University (February 3, 2010)
"Federal False Claims Act Amendments - Provisions and Implications for Life Science Entities," Center for Business Intelligence (September 1, 2009)
"How HIPAA and ARRA Impact Medical Device Manufacturers," Reed Smith University (August 5, 2009)
"HIPAA Privacy and Security: A Detailed Review," The George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 18, 2009)
"Revised AdvaMed Code: How More Stringent Industry Standards Will Affect Your Business," Reed Smith University Webinar (February 4, 2009)
"PhRMA Code Revisions: Understanding the New Changes and Evaluating Their Potential Impact," Center for Business Intelligence (August 12, 2008) (co-presenter)
"HIPAA Privacy & Security: Refresher, Recurring Misconceptions and Recent Developments," Reed Smith University (August 6, 2008)
"Stark and Anti-Kickback Laws: A Primer," Continuing Legal Education Seminar (January 23, 2008)
"HIPAA Privacy and Security Primer and Recent Developments in Enforcement," The George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 20, 2008)
"Stark Regulations, Phase III," Interview for the American Medical Association's News Program on XM Radio, ReachMD (September 17-27, 2007)
"Anti-Kickback and Stark Laws: How Hospitals Can Minimize Risks," Amerinet (August 21, 2007)
"Health Care Information Privacy: HIPAA Privacy, Security and Enforcement," George Washington University, School of Public Health and Health Services, Master of Public Health Program (February 21, 2007)
"Legal Challenges for Regional Health Information Organizations," Health Care Information and Management Systems Society (April 19, 2006)
"Protecting Patient Privacy: The HIPAA Administrative Simplification Provisions and the Privacy, Security, and Enforcement Rules," George Washington University, School of Public Health and Health Services, Master of Public Health Program (March 1, 2006)
"Health Care Fraud and Abuse Compliance Training," Academic Medical Center Training (February 2, 2006)
"Gainsharing: Strategies to Structure Cost Saving Arrangements," HCPro (September 15, 2005)
"HIPAA and Its Effect on Your Funeral Home," National Funeral Directors Association Annual Convention (October 19, 2004)
"State and Federal Privacy Laws: Navigating Through the Maze," HIPAA Summit VI (March 27, 2003)
"Modifications to the HIPAA Privacy Rule," Public Audioconference (September 9, 2002)
"HIPAA Privacy Challenges for Health Plans and Insurers," Health Insurance Association of America, Symposium on Confidentiality and Administrative Simplification (April 2001)
Publications
“OCR Issues Long-Awaited Omnibus HIPAA/HITECH Rules,” Client Alert (January 2013)
“HIPAA Privacy, Security, Breach Notification and Enforcement Rules - Quick Chart” (February 2011)
“Physicians Under the Microscope: The Anti-Kickback Law,” General Surgery News (July 2009) (co-author)
“HIPAA Privacy and Security Changes in the American Recovery and Reinvestment Act,” World Data Protection Report, Vol. 9, No. 5 (BNA May 2009) (co-author)
“AdvaMed Issues Revised Code on Interactions with Health Professionals,” Health Lawyers Weekly, Vol. VII, Issue 1 (January 9, 2009) (co-author)
“AdvaMed Issues Revised Code on Interactions with Health Professionals,” Reed Smith Memorandum (December 18, 2008) (co-author)
"PhRMA Issues Revised Code on Interactions with Health Professionals," Reed Smith Memorandum (July 18, 2008) (co-author)
"Kickbacks Abroad: The Foreign Corrupt Practices Act," Health Law Monitor (Summer 2007) (co-author)
"The Fundamentals of Life Sciences Law: Drugs, Devices and Biotech," American Health Lawyers Association (Spring 2007) (co-author)
"How to Prevent (or Respond to) a Data Security Breach and Identity Theft," Health Law Monitor (Spring 2007) (co-author)
"2007 Health Law and Compliance Update: The Stark Law" (Aspen, Nov. 22, 2006) (co-author)
"Nine Suggestions for Reinforcing a Privacy-Minded Culture," HealthLeaders (May 31, 2006)
"The Stark Law: A User’s Guide to Achieving Compliance," HCPro, Inc. (September 2005) (co-author)
"Gainsharing: Regulatory Breakthrough, but Challenges Remain," BNA Health Care Fraud Report" Vol. 09, No. 12 (June 8, 2005) (co-author)
"HIPAA Privacy and Security: How are Funeral Homes and Directors Impacted?," The Director (February 2005)
"Stark II, Phase II - Highlights and Preliminary Analysis," BNA Health Law Reporter Vol. 13, No. 14 (April 1, 2004) (co-author)
"Think Health Care Providers Don’t Need Patient Consent to Disclose Health Information? Think Again. A Review of the History of Consent Under the HIPAA Privacy Rule and an Analysis of HIPAA Preemption," BNA Health Law Reporter 1594 (November 7, 2002) (co-author)
"E-Health: Technologic Revolution Meets Regulatory Constraint," 19 Health Affairs No. 6, 124 (November/December 2000) (co-author)
