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Prosecuting and Defending Health Care Fraud Cases, Second Edition, with 2013 Cumulative Supplement


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Main Volume Information

Pharmaceutical Law: Regulation of Research, Development, and Marketing provides commentary and authoritative insights into a comprehensive range of pharmaceutical law issues. With the Medicare Part D drug benefit and the confusing methodology used for reimbursement adding pressures to the strained Medicare budget, increasing regulatory scrutiny and creating traps for the unwary, practitioners need this resource to stay on top of the law. They will be able to advise their clients on a host of areas that are receiving increased attention from regulators, including reimbursement and regulation, civil and regulatory liability under the securities and antitrust laws and compliance and corporate governance issues.

This treatise addresses the considerable fraud and abuse risks unique to this submarket of the health care industry; covers off-label marketing (selling a drug for a purpose other than its intended use); reviews the Medicare Part D drug benefit and its complexities; and explains and discusses other high-risk areas, including the potential for antitrust, securities law and other compliance violations.

Supplement Information

The  2013 Cumulative Supplement expands the scope of the book and provides new updates, including: 

  • New regulations on Medicare transparency reports that address obligations under 42 U.S.C. §1320a-7h that narrow the unambiguous language in the statute regarding the scope of “applicable manufacturers” who are required to report to the Secretary
  • Analysis of decisions reviewing whether the government may prosecute truthful, non-misleading statements about a product that are “off-label” as violations of the Food, Drug, and Cosmetic Act
  • Ongoing review of developments in sentencing in health care fraud prosecutions
  • Coverage of all significant new Office of Inspector General (OIG) Advisory Opinions issued under the federal anti-kickback statute, including Advisory Opinion Nos. 12-09 on “swapping” arrangements and 12-02 on the relationship between a website and providers that offers discount coupons to patients for certain services and sells advertising to the providers
  • Detailed analysis of trends in health care fraud settlements, in addition to updates to the compilation of virtually all settlements of at least $1 million 

Main Volume Information  

About the Authors
Michael K. Loucks 
is the former Acting U.S. Attorney and First Assistant U.S. Attorney for the District of Massachusetts. He is now a litigation partner with Skadden Arps, LLP, Boston, MA.

Carol C. Lam is the former U.S. Attorney for the Southern District of California.
Pharmaceutical Industry Blog on Michael Loucks’ Federal Career

An Article by Michael K. Loucks in Business Week magazine  

Supplement Information

By Michael K. Loucks

Main Volume Information

2010/1,216 pp. Hardcover/Order #9273P

Supplement Information

2013/646 pp. Softcover/ISBN 978-1-61746-093-7/Order #2273

Order 2013 Cumulative Supplement now.