Tag Archives: OIG

OIG Executive Exclusion Authority Alarming


Last week the Office of Inspector General (OIG) released a fact sheet to correct what it characterized as “inaccuracies” in the media coverage surrounding the notice of potential exclusion received by Howard Solomon, CEO of Forest Laboratories. The fact sheet clarifies that the OIG has not excluded Mr. Solomon from Federal health care programs, but its broader purpose appears to be to reiterate the OIG’s permissive exclusion authority and summarize the process it will follow as it expands its use of the authority against officers and managing employees at pharmaceutical and medical device companies. Continue reading

Small No Longer Means Safe: What You Need to Know


Today, the Wilson Sonsini Goodrich & Rosati (WSGR) Life Sciences Report for Spring 2011 was published. Thanks to David Hoffmeister and his colleagues for an insightful article.

Here are the GPP highlights:

Key Takeaway #1:  “While many of the more prominent fraud and abuse settlements have involved large-cap, public companies, small device and pharmaceutical companies should not consider themselves immune from investigation and prosecution by virtue of their size.” Continue reading

WSJ Fraud-Fighting Superhero vs. Physician Villains


Adding to the feeding frenzy, the media is piling on and doing their own healthcare fraud investigations.  Over the last month, the WSJ and Russell Adams (russell.adams@wsj.com) have published a series of articles on physician fraud and abuse based on their thorough analysis of public records.  And, now Dow Jones, the publisher of the WSJ is suing the American Medical Association (AMA) for access to full Medicare records in an effort to further expose fraud:

“The Medicare system is funded by taxpayers, and yet taxpayers are blocked from seeing how their money is spent,” said Robert Thomson, editor-in-chief of The Wall Street Journal. “It is in the interest of law-abiding practitioners that those who are gaming the system are exposed. Unless funds are used efficiently and intelligently, the health of the nation, physically and fiscally, will be undermined.” (excerpted from this WSJ article) Continue reading

Does Your Training Change Behavior?

Author: Dee Mahoney

In her Office of Inspector General update, at the recent Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Mary E. Riordan, Senior Counsel Office of Counsel to the Inspector General concluded her presentation with predictions for healthcare compliance trends for the pharmaceutical industry.  They included:

  • Increased number of cases against individuals
  • Continued large number of cases against pharmaceutical manufacturers
  • Increased number of cases against medical device manufacturers
  • Recent corporate integrity trends will continue Continue reading

Is Too Much Compliance Good or Bad?

Author: Mary Holloway

Earlier this year FDA Commissioner Margaret Hamburg promised more misdemeanor prosecutions for individuals in the healthcare industry.

On October 20, 2010, in a continued show of resolve to hold individuals accountable, the Office of Inspector General of the Department of Health and Human Resources published new guidance on permissive exclusion of officers and managers in the drug and device industry following a company plea.  If an individual is excluded it would significantly limit their ability to work in the health care field.  Federal healthcare programs (Medicaid, Medicare, Veterans Administration TRICARE, etc) will not pay for any items or services from an excluded individual.  In addition, an excluded individual would be prohibited from being employed, in any capacity, to provide any items and services which are billed to a Federal health care program. Continue reading