Medical Device Compliance Solutions - May 2012

Butler Snow LLP

In This Issue:

- Risky Business? Assessing Risks with A Risk Assessment Checklist

- Haunting Prose: Ghostwriting and Transparency in Pharmaceutical and Medical Device Publications

- 2012 In The Line Of Fire: Recent FCPA Enforcement Efforts In The Pharmaceutical/Medical Device Industry And The Importance Of An Effective Compliance Program

- Responsible Executive: Enhanced Compliance Efforts Encouraged To Avoid “Responsible Executive” Liability

Excerpt from Risky Business? Assessing Risks with A Risk Assessment Checklist -

On February 14, 2012, the 2011 Health Care Fraud and Abuse Control Program (HCFAC) Report was released, touting a 4.1 billion dollar recovery in 2011, the largest recovery since the 1997 inception of HCFAC. The government has proven a strong return on investment (ROI) with HCFAC producing a $5.1 to $1 ROI since 1997 and a $7.2 to $1 ROI for the years 2009 to 2011. Generally, these recoveries were focused on: average wholesale price, other price-related allegations, alleged off-label marketing (both pharmaceutical and device), alleged violations of laws against selfreferrals, alleged kickbacks, and other provider-related investigations and enforcement. The HCFAC Report indicated that approximately $2.4 billion of the recovery resulted through civil health care fraud cases brought under the False Claims Act (FCA).

Please see full newsletter below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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