Phase Two of the Open Payments program (Sunshine Act) went into effect on June 1, 2014. The Sunshine Act requires applicable manufacturers of drugs, devices, biologics or medical supplies and applicable group purchasing organizations (GPOs) to report certain payments to physicians or teaching hospitals. Data collection under Phase One of the Open Payments program occurred between February 18 and March 31, and involved (1) registration of applicable manufacturer and GPO authorized officials in the CMS Enterprise Portal, (2) submission of corporate profile information, and (3) submission of aggregate information about 2013 payment data. During Phase Two of the program, applicable manufacturers and GPOs are required to complete registration, data submission and attestation on the Open Payments system.
CMS has established two steps for Phase Two of the Open Payments program. Step one will occur between June 1 and June 30. Authorized officials from applicable manufacturers and GPOs will be required to: (1) complete registration in the Open Payments system; (2) confirm the accuracy of the reporting entity profile data submitted during Phase 1; and (3) delegate roles and responsibilities within the Open Payments system by nominating system users to fill specific user roles (officer, submitter, or attester). During this same time frame, system users who are submitters will be able to (1) upload and submit a test file to validate that the data file is formatted correctly; and (2) utilize the error report produced by the Open Payments system to correct any data errors in the file.
Step two will occur between June 9 and June 30. During this time, authorized officials or authorized representatives from applicable manufacturers and GPOs will be required to (1) submit final detailed 2013 payment or other transfer of value data or ownership/investment interest data, and (2) attest to the accuracy of the submitted data. Once the final data is submitted, the Open Payments system will match the records submitted by industry with physician and teaching hospital profiles. If the system is not able to match any of the data, the reporting entity will be notified and will have the opportunity to correct the data and re-submit the final data or to override the failed matching status and proceed with submission. Reporting under the Open Payments system is not considered complete until the official attestation is received. All Phase Two activities are required to be completed by June 30, 2014.
June 1 was also the first day that physicians and teaching hospitals were able to register on CMS’ Enterprise Portal, which enables them to review the information submitted on them by manufacturers and GPOs. Beginning in July, physicians and teaching hospitals will be able to register for the Open Payments system, which will notify them when data about them is submitted and will enable them to review and dispute the data before it becomes publicly available. Importantly, any disputed data that is not corrected by industry before the dispute resolution period ends will remain publicly available although it will be marked as disputed.