Finally, the long anticipated draft rules of the Patient Protection and Affordable Care Act, otherwise known as the Sunshine Act, were released by the Centers for Medicare & Medicaid Services. And there were some surprises. How will this affect your organization? How will your compliance have to change? How will this alter your Travel and Expense management? And what are some of the changes that key stakeholders have proposed?
Buchanan Ingersoll & Rooney FDA shareholder Linda Pissott Reig and her co-presenter will help uncover the key points at the "Shedding Light on the Sunshine Act" webinar. Topics that will be covered include:
Who are "applicable manufacturers" and "covered recipients"
Which drugs, devices, biologicals, and medical supplies are covered by the law
What details are required for each report & procedures for report submission and correction
The unique requirements for clinical trial expenditures, including "direct" and "indirect" research payments, and criteria for delayed release of such payment data on the internet