We have found that many studies neglect to have plans in place regarding the Sunshine Act. Don’t overlook this! Sunshine Act reporting is required in clinical studies, and it should be included in planning your activities to ensure reporting compliance.
The Sunshine Act, specifically the National Physician Payments Transparency Program, is part of the Affordable Care Act (ACA) that became law in 2010. It discloses the financial relationships between physicians, teaching hospitals, manufacturers, and group purchasing associations.
Some people have interpreted this regulation as requiring everything that’s distributed to a site to be reported, from disposables, to patient retention tools, to higher expensed equipment. Others have interpreted Sunshine Act reporting to be much less strict, narrowed down to only a few supplies. The act is primarily self-regulating, and this is the reason why the interpretations are so varied.
Every pharmaceutical organization is responsible for some level of reporting, regardless of its individual understanding of the law. Your company should have its own interpretation in place, which you should understand and adhere to. It is important that you plan for these reporting requirements early on to ensure effective and appropriate reporting throughout and after study completion.
As you are developing the plans and the structure to execute your next clinical trial, proactively putting processes and partners in place to assist with Sunshine Act reporting is one step toward easing the burden of compliance.
For more great tips, be sure to keep an eye out for our upcoming ebook, Ancillary Supplies for Clinical Trials: A Project Management Approach.