The long-awaited final rule for implementing the Physician Payment Sunshine Act was released by the Center for Medicare & Medicaid Services (CMS) on Friday, February 1, 2013 and published in the Federal Register on February 8, 2013.
The Sunshine Act, a subsection of the Patient Affordable Care Act of 2010, requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program (CHIP) to make annual reports of certain payments and transfers of value to physicians and teaching hospitals. Applicable manufacturers and group purchasing organizations (“GPOs”) are also required to make annual reports of certain physician ownership or investment interests. CMS is scheduled to publish these reports on a public website by September 30, 2014.
In addition to announcing the data collection and reporting dates, the Final Rule also addresses many outstanding questions including:
- Definitions for applicable manufacturers, common ownership and consolidated reporting
- Special rules for reporting research related payments, food and beverage expenses and continuing education programs
- Details about the CMS public website where the data will be published, as well as the secure website for reporting and correcting the data
- Federal preemption of similar state laws
Here we provide perspectives and expert insights on the Sunshine Act and the implications on life sciences company operations, ranging from written standards and training and education, to auditing, monitoring, tracking, collecting and reporting.