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. As set forth in the final regulations, applicable manufacturers and GPOs were required to begin data collection on August 1, 2013, and must file their first reports by March 31, 2014.
CMS recently posted new resources on its website to assist applicable manufacturers and GPOs in complying with the OPEN PAYMENTS Program. These resources include a “User Guide for Industry” (applicable manufacturers and GPOs), which is designed to simplify the complexities surrounding the collection and reporting of data to comply with OPEN PAYMENTS requirements, according to CMS. The User Guide is available in the “Downloads” section on the OPEN PAYMENTS website at the following address:
The link to the User Guide is located at the bottom of the page and is entitled “Guidance Manual.”
The User Guide addresses, among other things, general payments data collection, research data collection, data submission and attestation and includes additional information and resources. While the User Guide does not present new regulatory information, the User Guide does provide an overview of data collection requirements and the corresponding submission file specifications in a concise, user friendly format.
The User Guide is just one example of efforts by CMS to be responsive to industry’s questions. CMS frequently updates and releases FAQs, which are available on the OPEN PAYMENTS Program website. Additionally, CMS continues to host and participate in webinars regarding the OPEN PAYMENTS data collection and reporting requirements, in addition to addressing many complex questions posed by listeners. Most recently, CMS hosted a webinar on August 8, 2013. The slide deck, audio file, and transcript from the August 8th webinar presentation are now available here on the CMS website.