Medical Device Compliance Solutions - May 2012

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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).

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