Tag Archives: exclusion

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

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