Pharmaceutical companies, medical device manufacturers, and biotech companies are gearing up for the January 1, 2013 deadline set by the Centers for Medicare and Medicaid Services (“CMS”) for companies to begin collecting data under the federal Physician Payment Sunshine Act. But in the absence of long-awaited final implementing regulations, companies are struggling to understand what information they need to report, how to collect and report this information, and what this information will tell regulators and enforcers in an industry already under intense scrutiny. On October 16-17, 2012, industry executives and government officials gathered at ACI’s Physician Payments Disclosure and Aggregate Spend Conference in New York to discuss these and other questions, as well as the enforcement implications of Sunshine Act reporting.

PREPARING FOR SUNSHINE ACT REPORTING -

Executives from large pharmaceutical companies shared insights from their experiences operating under corporate integrity agreements that require the reporting of aggregate spend and other information to the government. Such corporate integrity agreements, which are often a component of global settlements of federal healthcare fraud investigations, require implementation of reporting systems that many smaller companies may not have the resources to support. Nevertheless, certain themes were repeated during each of the panels as speakers discussed how companies, regardless of their size, should prepare for Sunshine Act reporting...