In April, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG) released an updated Provider Self-Disclosure Protocol (SDP) (here). The revised SDP supersedes the original SDP issued in 1998 (here), and incorporates a series of open letters issued by OIG in 2006 (here), 2008 …
OIG Special Fraud Alert Warns Physician Owned Distributors of Enforcement Actions
April 12, 2013 Leave a Comment
The Department of Health and Human Services’ Office of Inspector General (OIG) recently released long-awaited guidance on Physician Owned Distributors. In a Special Fraud Alert released on March 26, 2013, OIG reiterated its long-standing position that physician-owned distributors (PODs) are inherently …
Is Off-Label Enforcement Off Limits?
December 7, 2012 Leave a Comment
On Monday, the Second Circuit Court of Appeals issued a split decision in U.S. v. Caronia, vacating the criminal conviction of a pharmaceutical sales representative who was found guilty of misbranding, in violation of the Food, Drug & Cosmetic Act (FDCA), because he had promoted the sleep medication Xyrem for …
With Boehringer Ingelheim FCA Settlement, Government Continues To Expand Off-Label Enforcement and Enhance CIAs
October 31, 2012 Leave a Comment
Boehringer Ingelheim Pharmaceuticals, Inc. (“BIPI”) is the latest pharmaceutical manufacturer to enter into a False Claims Act settlement with the Department of Justice (“DOJ”) predicated on off-label marketing and promotion. Last Friday, October 26, 2012, BIPI agreed to pay $95 million to resolve …
DOJ and GSK Enter Into Record-Setting $3 Billion Settlement, Expansive CIA
July 2, 2012 Leave a Comment
The Department of Justice today announced the largest-ever health care fraud settlement and largest-ever payment by a drug company. Global pharmaceutical giant GlaxoSmithKline LLC (GSK) agreed to pay $3 billion to resolve criminal and civil liability in connection with its drug sale and promotion practices, …
The ZPICs are Here! Is Your Organization Ready?
April 24, 2012 Leave a Comment
Effective April 24th, 2012, Cahaba Safeguard Administrators, LLC, the Zone Program Integrity Contractor (ZPIC) for Zone 3, is fully operational. Zone 3 includes the following states: Minnesota, Indiana, Michigan, Illinois, Ohio, Wisconsin and Kentucky. Implementation of a ZPIC contractor in Zone 3 was delayed …