Lexis Nexis AHLA Pharmaceutical and Medical Device Compliance Manual (Non-Members)
Publisher: AHLA
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The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical devices industry in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that.
Coverage includes:
• In-depth coverage of the federal and state enforcement agencies
• Federal Anti-Kickback Statute and False Claims Act details
• Distinction between manufacturers' lawful dissemination of scientific information and unlawful promotion of off-label use
• Discussion of the Foreign Corrupt Practices Act and its extra-territorial reach
• Coverage and reimbursement of prescription drugs and medical devices
• Prescription drug price regulations
The Manual includes guidance on building an effective compliance program and will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.
EDITORS
Kathleen M. Boozang, J.D., LL.M., Professor of Law, SETON HALL | LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJ
Simone Handler-Hutchinson, J.D., Executive Director, SETON HALL | LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJ
CONTRIBUTING AUTHORS
Bret A. Campbell, Esquire; Cadwalader, Wickersham & Taft LLP, Washington, DC; Sujata Dayal, Esquire; Biomet, Inc., Warsaw, IN; Michael Andre Donnella, Esquire; Wyeth, Madison, NJ; Katie Rose Fink, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Brett R. Friedman, Esquire; Ropes & Gray, LLP, New York. NY; Gary F. Giampetruzzi, Esquire; Pfizer, Inc., New York, NY; Christopher R. Hall, Esquire; Saul Ewing, LLP, Philadelphia, PA; Patrick M. Hromisin, Esquire; Saul Ewing, LLP, Philadelphia, PA; Elizabeth H. Kim, Esquire; Porzio Life Sciences, LLC, Morristown, NJ; Daniel A. Kracov, Esquire; Arnold & Porter, LLP; Washington, DC; Bruce A. Levy, Esquire; Gibbons, PC., Newark, NJ; Ann E. Lewis, Esquire; Ropes & Gray, LLP, New York. NY; Benjamin S. Martin, Esquire; Epstein Becker & Green, PC, Washington, DC; Joseph W. Metro, Esquire; Reed Smith, LLP, Washington, DC; Lewis Morris, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Kiaema R. Reid; Porzio Life Sciences, LLC, Morristown, NJ; Linda Pissott Reig, Esquire; Buchanan Ingersoll & Rooney, PC, Newark, NJ; Margaret Renner, Esquire; FDA (formerly Arnold & Porter), Silver Spring, MD; Mary Riordan, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Lynn Shapiro Snyder, Esquire; Epstein Becker & Green, PC, Washington, DC; Brian Tretick; Athena Privacy, LLC, Washington, DC; Robert E. Wanerman, Esquire; Epstein Becker & Green, PC, Washington, DC; and Mara E. Zazzali-Hogan, Esquire, Gibbons, PC., Newark, NJ
FDLI click here.
The fight against fraud and abuse in healthcare programs, and the pharmaceutical and medical devices industry in particular, continues to grow. Since 1996 the federal government has strengthened its efforts to detect and prevent fraud and abuse in healthcare, and has recovered $18 billion since 1997. These enforcement activities make a compliance program essential to protecting a company from running afoul of the myriad laws and regulations that have been enacted to combat fraud and waste. Pharmaceutical and Medical Device Compliance Manual includes guidance to help companies do that.
Coverage includes:
• In-depth coverage of the federal and state enforcement agencies
• Federal Anti-Kickback Statute and False Claims Act details
• Distinction between manufacturers' lawful dissemination of scientific information and unlawful promotion of off-label use
• Discussion of the Foreign Corrupt Practices Act and its extra-territorial reach
• Coverage and reimbursement of prescription drugs and medical devices
• Prescription drug price regulations
The Manual includes guidance on building an effective compliance program and will be a great tool for health and life sciences attorneys, compliance officers, and others in the pharmaceutical and medical devices industry.
EDITORS
Kathleen M. Boozang, J.D., LL.M., Professor of Law, SETON HALL | LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJ
Simone Handler-Hutchinson, J.D., Executive Director, SETON HALL | LAW, Center for Health & Pharmaceutical Law & Policy, Newark, NJ
CONTRIBUTING AUTHORS
Bret A. Campbell, Esquire; Cadwalader, Wickersham & Taft LLP, Washington, DC; Sujata Dayal, Esquire; Biomet, Inc., Warsaw, IN; Michael Andre Donnella, Esquire; Wyeth, Madison, NJ; Katie Rose Fink, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Brett R. Friedman, Esquire; Ropes & Gray, LLP, New York. NY; Gary F. Giampetruzzi, Esquire; Pfizer, Inc., New York, NY; Christopher R. Hall, Esquire; Saul Ewing, LLP, Philadelphia, PA; Patrick M. Hromisin, Esquire; Saul Ewing, LLP, Philadelphia, PA; Elizabeth H. Kim, Esquire; Porzio Life Sciences, LLC, Morristown, NJ; Daniel A. Kracov, Esquire; Arnold & Porter, LLP; Washington, DC; Bruce A. Levy, Esquire; Gibbons, PC., Newark, NJ; Ann E. Lewis, Esquire; Ropes & Gray, LLP, New York. NY; Benjamin S. Martin, Esquire; Epstein Becker & Green, PC, Washington, DC; Joseph W. Metro, Esquire; Reed Smith, LLP, Washington, DC; Lewis Morris, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Kiaema R. Reid; Porzio Life Sciences, LLC, Morristown, NJ; Linda Pissott Reig, Esquire; Buchanan Ingersoll & Rooney, PC, Newark, NJ; Margaret Renner, Esquire; FDA (formerly Arnold & Porter), Silver Spring, MD; Mary Riordan, Esquire; U.S. Dept. of Health & Human Services, Office of Inspector General, Washington, DC; Lynn Shapiro Snyder, Esquire; Epstein Becker & Green, PC, Washington, DC; Brian Tretick; Athena Privacy, LLC, Washington, DC; Robert E. Wanerman, Esquire; Epstein Becker & Green, PC, Washington, DC; and Mara E. Zazzali-Hogan, Esquire, Gibbons, PC., Newark, NJ
Table of Contents
Table of Contents
Preface
About the Authors
Introduction
1 Enforcement Authorities
2 Thou Shalt Not Buy Business: The Implications of the Anti-Kickback Statute on the Drug and Device Industry
3 False Claims Act
4 Advertising, Labeling, and Promotion
5 Drug and Device Development and Approval
6 Federal Healthcare Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices
7 Foreign Corrupt Practices Act
8 Privacy and Data Protection
9 Sunny Side Up: A New Era of State and Federal Aggregate Spend and Marketing Disclosure Laws
10 Elements of an Effective Compliance Program
11 Prescription Drug Price Regulation: Key Considerations for Compliance Officers
Compliance Glossary
Index
