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Gina M. Cavalier

Cavalier,GM_web image

Partner

Washington, D.C.

T:
+1 202 414 9288 (Washington, D.C.)
F:
+1 202 414 9299 (Washington, D.C.)
E:
gcavalier@reedsmith.com
Vcard

Gina is a partner in the Life Sciences Health Industry Group, and was recently named one of the nation's "Outstanding Young Healthcare Lawyers" by Nightingale's Healthcare News.  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 device manufacturers, DME suppliers, providers (e.g., hospitals, health systems, pharmacies and SNFs), health care industry trade associations, group purchasing organizations and payors.

In particular, Gina 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 drafted numerous corporate compliance programs, counseled clients regarding the structure of joint ventures and negotiated government settlements and corporate integrity agreements ("CIAs").  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. 

Gina has provided advice to clients on a host of reimbursement issues, including coverage, coding and payment under the Medicare program.  She has also handled cases before the Provider Reimbursement Review Board, drafted comments to numerous regulations and prepared legislative amendments to the Social Security Act.

In addition, Gina 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”).  Her experience includes resolving government investigations, negotiating business associate agreements, drafting authorizations, notices of privacy practices and policies and procedures, conducting preemption analyses, and providing day-to-day compliance guidance.

Publications

  • "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)
  • “Pushing Parentless Pharmaceuticals: Towards an International Home for ‘Orphan Drugs’ and a Cure for ‘Zebra Diseases,” 27 Law & Policy International Business 667 (1996)

Speeches / Presentations

  • "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)
  • “Hospital Responsibility In Identifying and Reporting Domestic Violence and Child Abuse,” DC Hospital Association (October 2000)

Experience

2006 Reed Smith (Health Care Group)
2000 Sonnenschein Nath & Rosenthal LLP (Partner, Health Care Group)
1997 Reed Smith (Health Care Group)
1996 United States Department of Justice (DOJ) Attorney General’s Honors Program (Judicial Law Clerk, Drug Enforcement Administration)

Legal Education

1996 J.D., cum laude, Georgetown University Law Center
Articles Editor, Law and Policy in International Business

Undergraduate Education

1993 B.A., with Distinction, summa cum laude, Boston University
Phi Beta Kappa

Professional Admissions / Qualifications

  • District of Columbia
  • New York

Professional Affiliations

  • American Health Lawyers Association
  • District of Columbia Bar Association: Health Law Section
  • International Association of Privacy Professionals

Honors, Awards and Professional Certifications

  • Recognized by "The Legal 500" as an "outstanding" heath care lawyer who "wins industry recognition" for her work in health care information privacy and security (2010)
  • Named one of the nation's "Outstanding Young Healthcare Lawyers" by Nightingale's Healthcare News (September 2009)
  • Certified Information Privacy Professional (CIPP) (2006)