Many organizations continue to face challenges with the technology and integration of some of the more complex interpretations.
On August 1, the U.S. Sunshine Act and its data collection obligations took effect. Applicable manufacturers and group purchasing organizations (GPOs) making payments or other transfers of value to physicians or teaching hospitals must now begin collecting required data components to be reported to the Centers for Medicare and Medicaid Services (CMS) by March 31, 2014. These data collection requirements have been long anticipated, yet many organizations continue to face challenges with the technology as well as the integration of some of the more complex interpretations. CMS has issued a number of helpful resources to assist implementation efforts.
For certain data collection categories, CMS has issued collection templates to educate impacted organizations on the applicable submission file specifications for general payments, research payments, and ownership and investment interest data submissions. Once the March 31, 2014 data submission deadline has passed, CMS will aggregate the data and publish it on its "OPEN PAYMENTS" website.
CMS has also published a list of teaching hospitals subject to reporting for the 2013 reporting year. Other significant CMS-issued communications include a series of frequently asked questions to help with interpretation concerns, a mobile application to help facilitate the collection of data, and fact sheets for the various interested parties (e.g., applicable manufacturers, GPOs, physicians, and teaching hospitals).
We have collected key regulatory resources and publications to help organizations prepare for the implementation process. For a complete archive of these materials, please visit the Morgan Lewis Transparency Compliance Resource Center. For more information on these issues or the topics discussed in this LawFlash, email our transparency team at TransparencyCompliance@morganlewis.com or contact any of the following team members:
. See Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests (U.S. Sunshine Act), 78 Fed. Reg. 9457 (Feb. 8, 2013) (codified at 42 C.F.R. pts. 402, 403).