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Government Prosecution in Qui Tam Cases Continues to Focus on Pharmaceutical Companies’ Sales and Marketing Activities

Qui tam actions filed against health care organizations unsealed in 2013 reveal that, although the government intervenes in less than 40% of qui tam actions, the government continues to aggressively prosecute multiple aspects of pharmaceutical companies’ sales and marketing activities, including kickbacks to physicians and pharmacy providers, in violation of the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law). Whistleblowers filing qui tam actions also continue to target false claims to Medicare, Medicaid, TRICARE, and federal defense procurement programs, and false certification of compliance with FDA laws and regulations regarding manufacturing practices and product quality, both in violation of the Civil False Claims Act. Claims involving unnecessary inpatient admissions from the emergency department (ED) or upcoding of hospitalist evaluation and management (E&M) also appear to be growing in number. The whistleblowers bringing the qui tam actions are former employees of health care organizations or employees of independent contractors to health care organizations, and auditors are more frequently filing qui tam lawsuits due to their ability to access organizational data directly. Click here to read more about specific health care qui tam cases in Mintz Levin’s Health Care Qui Tam Update.

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Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.