On February 7, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a notice (see CMS Bulletin) announcing that registration for Open Payments will finally begin on February 18, 2014. The oft-delayed Federal Physician Payment Sunshine Act and accompanying rules, 42 CFR Parts 402 and 403, require applicable drug and device manufacturers and group purchasing organizations to record payments and other transfers of value to physicians and teaching hospitals. The requirement applies to payments made on or after August 1, 2013. The notice contains some unexpected twists that could affect entities waiting to register and upload data.
First, registration and data uploading will be divided into two phases. This comes as a surprise — neither the final rule nor any of the recent CMS webinars regarding Open Payments registration and data submission hinted at a bifurcated process. Additionally, the notice does not fully explain the steps involved in each phase. The complete registration and data submission process requires the following:
- The person who will serve as the authorized official (an executive-level officer who can legally represent the organization) should register on the CMS Enterprise Identity Management Portal (EIDM Portal), which will feature Open Payments as an available business application in early 2014 (though it is not yet available).
- The authorized official will then register herself and the reporting entity on Open Payments, which must be done in one sitting, and which will be ready for registrants in early 2014 (though it is not yet available).
- The authorized official will then be vetted by CMS (CMS has advised entities to register early to allow time for this vetting process).
- Once vetted, the authorized official may either (1) elect to perform all functions with Open Payments, at which point the registration process is complete; or (2) nominate authorized representatives to perform specific roles within Open Payments on behalf of the entity.
- The authorized representatives can accept the nomination(s) by registering in both EIDM and Open Payments.
When these steps are completed, registration will be complete. It is unclear right now which of these steps will be included in Phase 1. It is possible only Step 1 above will occur in the first phase. The notice states that "[a]fter CMS Enterprise Portal registration has been completed [as described in the notice], the user will be directed to a webpage that will explain the requirements for Phase 1 data submission."
In addition, according to the notice, only aggregate data will be uploaded in Phase 1, with detailed data not due until Phase 2. Further, the final due date for detailed data has been pushed back. Though the final rule says that 2013 data should be uploaded no later than March 31, 2014, the notice gives applicable entities a little more time. Though the yet-to-be-defined aggregate data must be uploaded by March 31, 2014, final detailed data will be due sometime in the middle of the year, with June targeted by CMS.
Many questions remain. Will the entity need to register to upload aggregate data? Would the authorized official be vetted during Phase 1 or Phase 2? Can authorized representatives be nominated during Phase 1?
What does all of this mean for applicable entities? For one, the time spent attending webinars and prepping staff may have gone to waste, since a good chunk of the process could be altered by CMS. A less cynical view is that CMS is attempting to ease the administrative burden, as entities now have more time to complete the inaugural process.
Whether one views the glass as half full or half empty, covered entities will have less than six weeks to register and upload initial data. Because complexities and uncertainties remain, entities should not underestimate the time registration and initial reporting may take. 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.