CROS And The PPSA (Sunshine Act)

By James Neal, Endign

As a CRO you will be hearing more and more about the Physician’s Payment Sunshine Act or PPSA in the next few months. For those of you who are not familiar with the law, it was signed into law in 2010 as part of The Patient Protection and Affordable Health Care Act (more commonly known as Obamacare). The intention of the law is to make public the payments (or any transfer of value) between Pharmaceutical companies and Physicians or Teaching Hospitals. (there are links below if you’re looking for more information on the law – this article deals specifically with how CROs will be affected.)

As a CRO what parts of the law concern your organization and how will the law impact you?

As a CRO the law does not directly apply to your organization (or, better said, the CRO does not have to report to CMS.) Indirectly, the transactions most commonly handled by CROs – Investigator Payments, Training, Samples, etc. – are exactly the types of transactions that are at the heart of the new law. This means that your customers (Sponsors) will be looking for more information about these transactions.