On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) announced the release of the final regulations implementing the Transparency Reports and Reporting of Physician Ownership or Investment Interests section of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act.” The Sunshine Act requires applicable manufacturers of covered drugs, devices, biological products, and medical supplies to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations (“GPOs”) to report all ownership and investment interests held by physicians or members of their families.
On May 1, 2014, CMS announced that Open Payments registration for physicians and teaching hospitals will begin on June 1, 2014. While registration is voluntary, physicians and teaching hospitals must register with CMS if they would like to review information regarding payments or other transfers of value given to them by applicable manufacturers and applicable GPOs prior to public posting of the data. Registered users will be able to dispute information they believe is inaccurate or incomplete. Any disputed data that is not corrected by the applicable manufacturer or applicable GPO will be made public, but will be marked as disputed.
There will be a two-phased registration approach for this first reporting year. Phase 1, which will begin on June 1, 2014, includes user registration in CMS' Enterprise Portal. Phase 2, which will begin in July 2014, includes physician and teaching hospital registration in the Open Payments system, and will allow them to review and dispute data submitted by applicable manufacturers and applicable GPOs prior to public posting. CMS has indicated that it will provide additional guidance regarding the registration process in the coming weeks. CMS will also provide guidance when Phase 2 registration and the review and dispute process begins.