Tag Archives: HHS

4 Synthes Execs Indicted for Off-Label Promotion


Last Sunday’s Philadelphia Inquirer reported on the indictments of four high-level medical device executives for off-label marketing practices. The indictments mark a next step in the enforcement of off-label marketing practices in the US.

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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

Under Investigation: 180 Qui Tams for Pharma or Device Fraud


In May 2009, the Department of Justice (DOJ) and Human Health and Human Services (HHS) announced the creation of the Health Care Fraud Prevention and Enforcement Action Team (HEAT).  As part of a larger effort by the Obama administration, HEAT and its parent organizations have made the fight against Medicare fraud a Cabinet-level priority.  The purpose of HEAT is to build upon existing partnerships between the DOJ and HHS and gather resources across the government to help prevent waste, fraud and abuse in the Medicare and Medicaid programs. Continue reading

Pharma Exec Banned from Govt Business


OIG/HHS announced today that the former Chairman and CEO of KV Pharmaceuticals, Marc Hermelin, has been banned from conducting business with the US Federal Government for 20 years.  He resigned his position on November 10th in an effort to prevent exclusion of KV from selling drugs/medicines that are reimbursed by Medicare, Medicaid, and Tricare.  HHS has been promising to pursue exclusion of executives, and we now have our first example in pharma. 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