Life Sciences Alert

The Physician Payment Sunshine Act Final Rule

February 8, 2013

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited Physician Payment Sunshine Act (Sunshine Act) Final Rule, implementing Section 1128G of the Social Security Act.

The Sunshine Act (passed in 2010 as part of the Affordable Care Act and summarized here) requires applicable manufacturers of covered drugs, devices, biologicals, and medical supplies to report annually all payments and other transfers of value to physicians and teaching hospitals.

However, the language of the Sunshine Act left many open questions about its applicability and implementation; CMS issued a proposed rule to address these issues in December 2011 (summarized here) and solicited comment on that rule. After over a year of delay, CMS has issued a Final Rule to address the questions and comments it received.

Most notably, the Final Rule:

  • Establishes August 1, 2013 as the starting date for the recording of data and March 31, 2014 as the first deadline for reports;
  • Excludes many foreign entities from reporting;
  • Excludes certain medical education programs from the disclosure requirements;
  • Creates separate reporting and publishing procedures for payments related to research; and
  • Excludes from reporting large group meals where recipients are difficult to identify and establishes a reporting process for smaller group meals.

To find out more, click here.