Sunshine Act Expansion: Life Sciences Companies Need to Prepare for 2021 Data Collection

The U.S. Sunshine Act (Open Payments) expanded the definition of 'covered recipient' to include five additional provider types: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. Starting with 2021 data collection, life sciences companies must track payments or transfers of value to these new HCPs. The CMS Final Rule requires reporting direct or indirect payments, with penalties up to $10,000 to $100,000 per line item. Companies need to update systems, data management, and training to handle a potential increase of 350,000 to 400,000 reportable individuals.