The federal Department of Justice, the Office of Inspector General (OIG) at the Department of Health and Human Service, state Medicaid fraud control units, and other enforcement agencies have brought multiple enforcement actions against various healthcare practices - even small practices - over the course of the past twenty years.
The institutional risks of billing noncompliance have grown since 1995 from relatively non-adversarial audits and occasional return of payments to formal investigations, prosecution under the False Claims Act, and whistleblower action.
The personal risks of billing noncompliance have changed too from money return to exclusion from government programs and loss of practice license. Administrators can be barred from working in the healthcare industry and clinicians, managers, corporate directors, even outside consultants can be jailed for healthcare fraud and abuse.
The federal government strongly encourages health compliance programs and promotes voluntary billing compliance and self-policing in a variety of ways. For instance, in the case of Medicare and the OIG, the existence of a corporate compliance program influences the approach to a violation of a federal requirement in terms of an innocent mistake or a fraudulent act. The existence of a corporate billing compliance program may determine whether the matter can be routinely handled as an overpayment by the payer or it must be investigated by the OIG, or even referred to the Department of Justice to be pursued as a civil infraction or as a criminal matter (http://oig.hhs.gov/fraud/complianceguidance.html).
Generally, compliance programs programs are not required by law. Unless a practice has been ordered to implement such a plan by a court of law or has agreed to a compliance plan as part of a settlement agreement, each group is free to decide about development of such a program and its extent.
The Federal Sentencing Guidelines are designed to ensure consistency in criminal sentencing by federal judges for federal crimes. These guidelines describe seven elements that must be included in the program for it to be counted as an effective compliance program. If a compliance program was in place, and deemed to be effective, the sentence will be less harsh. Both the existence and the efficacy of a compliance program are necessary to receive a less harsh sentencing.
The Sentencing Guidelines define an “effective program to prevent and detect violations of law” as a program that has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal conduct and will include at least the following seven elements:
OIG lists the following items as specific regulatory risks most frequently subject to investigation and audit:
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