DOJ’s West Outlines Enforcement Considerations

By Anne K. Walsh –

On November 2, 2011, DOJ’s Assistant Attorney General Tony West gave a keynote address at the Twelfth Annual Pharmaceutical Regulatory and Compliance Congress in Washington, DC.  During that speech, he touted DOJ’s “successes” against health care fraud achieved during the last three years he has headed up DOJ’s Civil Division.  In addition to noting the recent Executive Order on drug shortages, described here, he talked about the results of the HEAT task force (a not-so-precise acronym for the Health Care Fraud Prevention and Enforcement Action Team).  He stated that since May 2009, HEAT has opened more health care fraud investigations, charged more criminal health care fraud defendants, and recovered more money (over $8 billion) than ever before.   And there is no indication that the government’s focus is dissipating.

According to West, not only will DOJ continue to target off-label marketing and False Claims Act cases, but it also will look to bring more cases involving counterfeit drugs, drug diversion, kickbacks, and fraud in home health care and nursing homes.  And he claims that in doing so, DOJ intends to reach more aggressive resolutions.  West reiterated DOJ’s threat to use the familiar Park doctrine for holding corporate officials responsible, but also stated that providers, companies, and even physicians, should be held responsible for violations. 

West recognized, however, that there are other ways to combat fraud than merely scaring companies and people with enforcement.  He stressed that there is a need to promote a culture of compliance through deterrence and preventative efforts.  He also identified the need for creative non-monetary resolutions, such as obtaining post-conviction supervision over companies, to allow companies to prevent and detect future violations.   Lastly, he stressed that it is his priority to treat fairly companies that voluntarily disclose their fraud to the government, and cooperate fully during an investigation.  He specifically used as an example of cooperation the timeliness and thoroughness of document production.  West seeks to encourage more of this behavior from companies. 

These are all good strategies to keep in mind when negotiating with this Division.