Theranos: New Compliance Program Hopes to Save the Company

Gilbert Carrillo Executive Editor Loyola University Chicago School of Law, JD 2017 Edmund Tyrrell Associate Editor Loyola University Chicago School of Law, JD 2018   Theranos, the American health-tech and medical-lab-services company, recently hired two executives to oversee regulatory compliance standards. The executives were hired following Theranos receiving multiple sanctions from U.S. regulators about the …
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Mylan Medicaid Fraud Investigations

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   Mylan has already been under public scrutiny for increasing the price of its EpiPen allergy shots. Last week the State of West Virginia launched a Medicaid fraud investigation questioning Mylan’s price hike and compliance with drug rebate laws. Mylan Pharmaceuticals participates in …
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CMS Issues Proposed Rule Addressing Multiple Fraud and Abuse Concerns

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   The Centers for Medicare and Medicaid Services (CMS) recently proposed a new rule in the Federal Register that addresses changes in Medicare payment policies. The proposed rule aims to inform providers of proper billing practices and prevent fraud and abuse.  This post …
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Medicare Advantage Audits Reveal Alleged Rampant Upcoding

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   Last month, the Center for Public Integrity obtained over three-dozen new Medicare Advantage (MA) audits through a lawsuit brought under the Freedom of Information Act. The audits indicate that overcharging is still a pervasive problem in the MA Program because Medicare Advantage …
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Medicare Regulations Compliance for Long-term Care Hospitals-within-Hospitals

Christine S. Kim Assistant Editor Loyola University Chicago School of Law, J.D. 2017   Due to the inextricably association between long-term care Hospitals-within-Hospitals (“HwHs”) and their respective Long Term Care Hospitals (“LTCH”), or host hospitals, efforts to circumvent compliance with federal reimbursement regulations have evolved. This blog article discusses the ways in which the Centers …
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Impaired and On the Clock: Developing Policies and Procedures to Cope with Impairment in the Workplace

Brittany Tomkies Executive Editor Loyola University Chicago School of Law, JD 2017   Drug and substance abuse has become an epidemic in the United States over the past 15 years, reaching an alarming 9.4% of Americans ages 12 and older in 2013. The human and economic costs of substance abuse are astonishing – some estimate …
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19 Ingredients, 2.2 Million Pounds of Product and $368.7 Million to Comply

Brittany Tomkies Executive Editor Loyola University Chicago School of Law, JD 2017   The Food and Drug Administration (FDA) issued a final rule on September 2, 2016 establishing that certain over-the-counter (OTC) consumer antiseptic wash products (i.e. antibacterial hand and body soaps) containing certain active ingredients can no longer be marketed as they are not generally …
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Another Suit against Vanguard Healthcare

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   In 2011, Vanguard Healthcare, LLC (“Vanguard”) settled a whistleblower suit for Medicare and Medicaid fraud and entered into a Corporate Integrity Agreement (CIA). Now the federal government is suing Vanguard for submitting fraudulent claims for services that were “either non-existent or grossly …
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