Category: Corporate Compliance

OIG Releases FY2016 Work Plan: Areas to be Reviewed Include SNFs, Drug Pricing, HIPAA

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released this week its FY2016 Work Plan (Work Plan). The OIG Work Plan summarizes new and ongoing OIG reviews of various HHS programs and activities, which are selected based on a number of factors such as mandatory OIG review […]

Court Holds Corporate Integrity Agreement May Be Basis for Reverse False Claim Liability

This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon, Inc. The motion to dismiss relates to claims made by the whistleblowers under 31 U.S.C.§ […]

TREND WATCH: GOVERNMENT USE OF DATA ANALYTICS TO IDENTIFY HEALTH CARE FRAUD

Data analytics is not a new concept within the health care industry. However, as data analytics tools become more accessible, government interest in using data analytics to detect health care fraud continues to increase. Government investigators also have been vocal in informing the health care industry that this powerful tool […]

Resource Launch: Key Considerations for Health Care Fraud Government Investigations/Inquiries

Cooley is excited to release a new resource for health care and life sciences companies: Key Considerations for Health Care Fraud Government Investigations/Inquiries. This quick reference documents provides a list of steps that companies should consider taking before a government investigation/inquiry occurs, and key steps to take if a becomes aware of a […]

Resource Launch: 20 Key Considerations for Implementing an Effective Corporate Compliance Program

Cooley is excited to release a new resource for health care and life sciences companies: 20 Key Considerations for Implementing an Effective Corporate Compliance Program.  This quick reference document provides an overview of key areas that a company should consider as it seeks to implement and improve its corporate compliance programs. […]

HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015.  The Work Plan is a compilation of the OIG’s plans for new and ongoing reviews and activities (including audits, evaluations, and certain […]

9th Circuit Upholds Alameda County Manufacturer-Funded Drug Disposal Ordinance

On September 30, 2014, the U.S. Court of Appeals for the 9th Circuit unanimously upheld a lower court’s finding that a California county ordinance requiring prescription drug manufacturers to operate and finance certain drug disposal operations was constitutional.  The plaintiffs-appellants in Pharm. Research & Mfrs. of Am v. County of Alameda (9th Cir., […]