It’s really happening, and fast. On Friday, February 7th, CMS issued a notice (here) announcing that registration for Open Payments would begin on February 18th, and also surprised us with a two-phase process not provided for in the final rule. The oft-delayed Federal Physician Payment Sunshine Act and accompanying rules, 42 CFR Parts 402 and 403, required that applicable manufacturers and group purchasing organizations record transfers of value to covered entities, as well as certain investment interests, for CY 2013, beginning August 1, 2013. The notice set forth a number of items that will affect entities waiting to register and upload data.
First, entities will have less than six weeks to register and upload initial data. This provides little time, especially once the process is taken into consideration. First, the person who will act as the authorized official (an executive-level officer who can legally represent the organization) must register on the CMS Enterprise Identity Management Portal (the “EIDM Portal”). Once in the EIDM Portal, the person will then request access to Open Payments. At that point, the authorized official can access the instructions for submitting aggregate data, instructions that industry has yet to see.
Which brings us to the second takeaway from the CMS notice – the inaugural upload will be divided into two phases, a new development not previously disclosed by CMS. Phase 1, which concludes on March 31st, requires only that aggregate data be uploaded. Again, details on the requirements of the Phase 1 aggregate submission will be provided to users once registration with the EIDM Portal is complete. Phase 2, which CMS approximates will begin in May, will require further registration with Open Payments as well as detailed data submissions.
The new process and tight timeline leave many unknowns. First, prior to the Phase 1/Phase 2 format, authorized officials were to be vetted by CMS, a process that could take up to two weeks, according to CMS. It is unclear whether this lengthy requirement must take place during Phase 1, or during Phase 2. Additionally, the authorized official may nominate others to serve as authorized representatives who are able to perform certain functions within Open Payments, such as submitting or attesting to data. To accept the nominations, the authorized representatives would need to separately register in both the EIDM Portal and Open Payments. Again it is unclear whether the nomination process will occur during Phase 1, or during Phase 2. Finally, industry has not been allowed to upload test files to determine whether data is correctly formatted into appropriate .CSV or .XML files. Uploading data could be a vexing proposition to those entities lacking a robust IT department.
The point is that applicable entities should register as soon as possible to allow for delays in the Phase 1 process and to account for any unknowns.
Stay tuned for further updates on the registration process. To monitor information as it becomes available, sign up for the Open Payments listserv.