The ultimate effectiveness of the corporate compliance program depends on its ability to mitigate risks arising from all substantive laws materially affecting the company — not only the most visible or notorious ones. Yet, both experience and impression suggest that many health company compliance programs are primarily focused on addressing concerns arising from the anti-fraud and abuse, self-referral and reimbursement rules. This level of focus is understandable, given the historical prominence of these rules and the strong public voice of the U.S. Department of Health and Human Services Inspector General. However, such program imbalance can itself lead to significant compliance concerns given the increasing extent to which the civil and criminal antitrust laws are applied to the health care sector.
The fundamental purpose of a corporate compliance program is to detect the particular types of misconduct most likely to occur in a particular corporation’s line of business. The parameters of most programs are based upon the core “effectiveness” principles set forth in the Federal Sentencing Guidelines. Specific details of particular programs often reflect guidance provided by regulators with particular interest in certain industries. For example, the compliance programs of many health industry companies follow DHHS regulations that set forth basic principles of such programs, and specific anti-fraud elements that companies should consider when designing and implementing their programs.
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