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The differences and similarities between American and Italian healthcare fraud, waste, and abuse laws: Part 2

Pamela Coyle Brecht ( serves as Pietragallo Gordon Alfano Bosick & Raspanti LLP’s Practice Chair for the firm’s global Qui Tam/False Claims Act Practice Group in Philadelphia, PA. Paola Sangiovanni ( is a life sciences lawyer and partner in the law firm of Gitti and Partners, which is located in Milan, Italy. Her clients include med tech, pharma, and healthcare providers. Marc Stephen Raspanti ( is a name partner of Pietragallo Gordon Alfano Bosick & Raspanti LLP, located in Philadelphia, Pennsylvania. He is the founder of the firm’s White Collar Criminal Defense Practice Group as well as the firm’s Qui Tam/False Claims Act Practice Group.

Part 1 of this article series, published in the November 2021 issue of Compliance Today, outlined in general the American and Italian healthcare systems. Part 2 outlines America’s primary healthcare fraud laws. Part 3 of this series, to be published in the January 2022 issue of Compliance Today, will outline Italy’s fraud and abuse laws.

In America, the enforcement landscape is ever evolving. Compliance within this thicket of criminal, civil, and administrative laws and regulations can prove especially challenging. The most used fraud and abuse prevention tools include the federal Anti-Kickback Statute (AKS), the federal False Claims Act (FCA), state false claims acts (FCAs), Stark Law, and more recently the Physician Payments Sunshine Act. In addition to these laws, there are two important industry codes of conduct that govern behavior: the PhRMA Code on Interactions with Health Care Professionals, which covers the pharmaceutical industry, and the AdvaMed Code of Ethics, which covers the medical device industry.

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