The Yates Memo In Healthcare: Pursuing Civil, Criminal, And Administrative Penalties

Posted On Thursday, October 27, 2016

It has been a year since the Yates Memo memorialized and clarified the government’s policy on individual accountability for corporate wrongdoing.  Initially, there was some debate whether the Yates Memo would change government practice, as many government officials and others saw it as a continuation of policy, rather than a significant departure from prior practice.  But a year in, it has become apparent that the government has placed a greater emphasis on pursuing individuals.  One arena where that emphasis is particularly apparent is healthcare. Below is a brief summary of some of most significant actions – both criminal and civil – that the government has taken against individuals in the healthcare industry. 

In United States v. Facteau, Case No. 1:15-CR-10076 (D. Mass.), the government charged former Acclarent executives, William Facteau and Patrick Fabian, with felonies relating to the off-label marketing of a nasal device, which the defendants allegedly promoted in an aggressive fashion to make the company attractive for purchase or an initial public stock offering.  On July 20, 2016, Facteau and Fabian, who succeeded in selling the company to Johnson & Johnson, were acquitted of the felony charges but convicted of misdemeanors.

On September 27, 2016, the former CEO of Tuomey Healthcare System, Ralph J. Cox, III, agreed to pay $1 million and to a four-year exclusion from participation in federal healthcare programs to settle claims involving his role in that system’s violation of the Stark Law.  As part of the settlement, Cox did not admit liability.  The resolution against the individual came after Tuomey suffered defeat in a jury trial and the district court entered a judgment under the False Claims Act in favor of the United States for $237.4 million. United States ex rel. Drakeford v. Tuomey Healthcare System, Inc., Case No. 3:05-CV-02858 (D.S.C.). The government later agreed to resolve the judgment against Tuomey for $72.4 million. 

On October 12, 2016, four former executives of American Senior Communities, an Indiana nursing home chain, were indicted for their alleged roles in a kickback and fraudulent overbilling scheme. United States v. Burkhart, Case No. 1:16-CR-212 (S.D. Ind.).  It is unclear whether an investigation against the corporate entity persists.

June 22, 2016, saw an unprecedented nationwide sweep led by the multi-agency Medicare Fraud Strike Force that resulted in the arrest of 301 individuals, including 61 healthcare professionals, in 36 districts.  The individuals were all charged with participating in various fraudulent schemes, which allegedly resulted in approximately $900 million in false billings to Medicare.

Finally, though the case has not yet yielded actions against individuals, Pfizer and Wyeth’s $785 million settlement to resolve allegations of reporting false drug prices to Medicaid included cooperation provisions. United States ex rel. Kieff v. Wyeth Pharmaceuticals Inc., Case Nos. 03-CV-12366, 06-CV-11724 (D. Mass.) Under those provisions, the companies must: cooperate with investigations concerning “individuals and entities not released” from liability in the settlement; make “former directors officers and employees available for interviews and testimony”; and produce to the government non-privileged documents concerning the conduct covered in the settlement.  Thus far, the government has required cooperation provisions in 46% of all corporate settlements in Fiscal Year 2016.