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 …
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 …
More Problems With ZPICs
September 25, 2012 Leave a Comment
A recent OEI report found troubling conflicts of interest and financial relationships among potential Zone Program Integrity Contractors (ZPICs) used by the Centers for Medicare & Medicaid Services (CMS) in their controversial new National Fraud Prevention Program. Medicare fraud costs the government an …
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 Wrinkle In Dinkel: The Departmental Appeals Board (Re)Defines the “Should Have Known” Standard for Exclusion Actions Under 1128(b)(7)
April 19, 2012 Leave a Comment
In a recent application of the Exclusion Statute, Social Security Act § 1128 et seq., the Department of Health & Human Services Departmental Appeals Board (Board) clarified that providers have an affirmative obligation to understand and correctly apply Medicare billing rules. In doing so, the Board arguably …