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.

There have been discussions about the impact of these changes specifically on the individuals that have a very high exposure of risk, e.g. the certifying employee who is being held accountable for compliance in their area.  How do you discuss this without paralyzing the employee or future candidates for this role?  Is too much information a good or bad thing?

In the current regulatory environment that the industry is faced with, it is vital that certifying employees know and understand the scope of the law and the possible consequences.  Certifying employees should understand that a “head in the sand approach” won’t make it go away.  To minimize the risk, leaders need to be proactive about their approach to compliance and ensure that their compliance policies are translating to compliant field conduct.

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