Health Law Advisor

Both the Department of Justice and the Department of Health and Human Services Inspector General have long urged (and in many cases, mandated through settlements that include Corporate Integrity Agreements and through court judgments) that health care organizations have "top-down" compliance programs with vigorous board of directors implementation and oversight. Governmental reach only increased with the publication by DoJ of the so-called Yates Memorandum, which focused government enforcers on potential individual liability for corporate management and directors in ...

On March 26, 2012, the U.S. Department of Health & Human Services Office of Inspector General (the “OIG”) published a report summarizing a February 23, 2012roundtable meeting between the OIG and compliance professionals from twenty-three pharmaceutical manufacturers.  The compliance officers and other professionals attending the meeting all represented companies currently operating under Corporate Integrity Agreements (or “CIAs”).  CIAs are generally negotiated between a company and the government in connection with settling various types of federal ...