In his testimony before a House of Representatives subcommittee, Chief Counsel for the HHS-OIG Lewis Morris expressed the Federal Government’s frustration with repeat offenders and indicated a new strategy for fighting fraud and abuse among health care enterprises:
“We are concerned that the providers that engage in health care fraud may consider civil penalties and criminal fines a cost of doing business. . . . One way to address this problem is to attempt to alter the cost-benefit calculus of the corporate executives who run these companies. By excluding the individuals who are responsible for the fraud, either directly or because of their positions of responsibility in the company that engaged in fraud, we can influence corporate behavior without putting patient access to care at risk.
HHS, the Justice Department, and the Food and Drug Administration have been independently shifting their target to individual executives in health care fraud investigations and prosecutions. Executives at drug companies, medical device companies, nursing homes, and other health care groups now have more to worry about than the hefty fines their companies are forced to pay; these executives could face criminal charges even if they were not involved in the scheme and exclusion from the Federal programs.
Morris continued, saying that “when there is evidence that an executive knew or should have known of the underlying misconduct of the organization, OIG will operate with a presumption in favor of exclusion of that executive.” To be sure, exclusion from the federal programs is a career ender, as the enterprise would no longer be able to bill the federal programs with the excluded executive at the helm. The authority the OIG points to for this power is under section 1128(b) of the Social Security Act, which allows OIG to hold responsible individuals accountable for the misconduct of their organization. It is only recently, however, that OIG has been focusing on using this power on the top executives of these organizations. It used to be that only executives who had been charged and entered pleas were excluded. Last year, however, the inspector general excluded the owner/executive of drug manufacturer Ethex Corporation even though the Justice Department did not charge him.
But this theory was recently tested and HHS retreated. Howard Solomon, chief executive of drug company Forest Laboratories, received notice from HHS-OIG that he would be excluded from the Federal programs. Solomon received the letter because a Forest subsidiary pleaded guilty to marketing violations in 2010 and agreed to a $313 million settlement, but Solomon was not personally charged and there was never any alleged wrongdoing on his part. According to a press release from Forest, the “only basis given in the letter notifying Mr. Solomon of the potential action is that he is ‘associated with’ Forest.” Ultimately, after protest from the business community, HHS retreated from its exclusion letter.
Despite HHS backing down against Solomon and Forest, the climate of investigations and prosecutions against executives is still heating up. As Morris said in a May Associated Press interview, “[t]he behavior of a company starts at the top.” In the ever growing culture of compliance coming out of Washington, it is more important than ever for executives to become involved in their organization’s ongoing compliance efforts, and to hold subordinates accountable for running a compliant organization.