On November 27, 2012, the Office of Management and Budget (OMB) received final regulations from the Centers for Medicare and Medicaid Services (CMS), which would implement the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act. CMS previously missed the October 1, 2011, deadline to establish regulations implementing this section, which is commonly referred to as the “Sunshine Act.” The text of the final regulations is not currently available for viewing.
CMS released proposed regulations to implement the Sunshine Act in December 2011. The Sunshine Act requires drug, device, biological product, and medical supply manufacturers to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires manufacturers and group purchasing organizations (GPOs) to report all ownership or investment interests held by physicians or members of their family. Although the Sunshine Act statute requires manufacturers and GPOs to begin collecting data starting January 1, 2012, CMS has previously indicated that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013.