Yesterday, February 25th, CMS hosted a webinar titled, “Open Payments Phase 1 of 2 – Overview of Industry Data Registration & Data Submission.”  As the name implies, it discussed the various aspects of the Phase I, which requires applicable manufacturers to submit aggregate data on transfers of value to covered recipients and teaching hospitals, as well as disclosure of ownership interests.  A more in-depth discussion of Phase I is available in our previous blog post, here.

The webinar clarified a number of things.  First and foremost, the definition of aggregate data was revealed.  Applicable manufacturers will need to disclose three pieces of information: (1) the total aggregate amount, in dollars and cents, of transfers of value for the applicable period; (2) the total number of transfers of value; and (3) the total number of covered recipients who received a transfer of value or the total number of physician owners and investors.  CMS clarified in the Q & A that these numbers should include delayed research payments.  This information will be emailed to CMS by the authorized official or by a delegate—the email address is provided in the instructions document (see below on accessing this).  If the email is sent by a delegate, the email must include the authorized official’s EIDM UserID and password.  A data template is available on Open Payments here.

Additionally, CMS explained the registration process in more depth.  As an initial matter, there will be no consolidated reporting for Phase I.  All applicable entities must engage in the Phase I process.  Regarding the nuts and bolts of the process, the person who will serve as the authorized official will first register with the CMS Enterprise Identity Management system (EIDM Portal).  This will include the authorized official entering personal information so that her identity may be verified by Experian, a third party contractor.  The authorized officials UserID and password will be selected at that time.

Once registration with the EIDM is complete, the authorized official may login to the EIDM Portal and request access to Open Payments.  CMS noted that though there are many options, the authorized official’s “role,” which is selected during this process, is “Open Payments User.”  To complete the process, and acquire access to Open Payments, the authorized official must confirm her identity by answering questions gleaned from the EIDM registration.

Once the authorized official is able to access Open Payments, she will be able to log on, at which point the web page will prompt the authorized official to download the detailed instruction for data submission.  These instructions will include the email address to which the data must be sent, as well as resources to aid with data submission.  Note that the authorized official will not be able to nominate representatives until Phase II.  Additionally, an assumptions document may not be provided to CMS until Phase II.