It is premature to gain an understanding of precise reporting requirements and the reporting format for Physician Payments Sunshine Act, as HHS, the governing authority, has not yet commenced this effort. However, this does not preclude the drug, biologic or medical device manufacturers from proactively ascertaining the data challenges and risks, and instituting steps to address the reporting requirements if Physician Payments Sunshine Act becomes a law.
Maine, Massachusetts, Minnesota, Vermont, West Virginia and the District of Columbia have enacted “sunshine laws” setting limits on industry payments to physicians and/or requiring disclosure of the payments. Although, some are limited by resources or mechanism for enforcement and have short-term and manually intensive solutions, the interpretation of state requirements will facilitate understanding of data collection, consolidation and validation process for Physician Payments Sunshine Act reporting requirements.
Most of the data that is required to be reported is either manually captured, exists in legacy systems and flat files and/or is distributed across disparate applications and databases. The figure below illustrates the categories of data elements that will be required.
What can companies do to prepare for compliance with the Physician Payments Sunshine Act? First step, is an assessment of Current State and development of a roadmap that will encompass business process and technology aspects of the required future sate. Most corporations have Master Data Management projects on their strategic planning path. Corporations that have established Customer Master will have an added advantage as unique customer identification will be necessary for reporting. Similarly, corporations that have implemented ERP systems for Medical Affairs, Sales and Marketing, HR and legal data will reap the benefits of data consolidation. This, however, does not undermine the effort of a consolidated Data Integration and Validation strategy that will be required.