The Centers for Medicare & Medicaid Services (CMS) held two webinars today for applicable manufacturers and applicable group purchasing organizations (GPOs) related to the Open Payments registration and data submission processes.  With regard to registration, CMS informed manufacturers and GPOs that there will be a two-step process as follows:

  1. Registration with CMS via the Enterprise Identity Management (EIDM) system.  This process allows the entity to obtain EIDM credentials.  Entities may have EIDM credentials if they use other CMS business applications.  This registration is open now to entities. 
  2. Registration with the CMS Open Payments system.  This system requires an authorized official profile and entity profile to be completed together in one session.  The authorized official completing the profiles must be a “C-level executive or equivalent”, such as a CEO, president or owner.  The name, title, business address, business phone and email address must be provided for the authorized official, and the entity profiles requires the legal name, DBA name, business address, business phone, entity TIN/EIN, D&B D-U-N-S number, FDA FEI number, URL of parent company website and whether a consolidated report will be submitted. Each applicable manufacturer or GPO must complete this registration even if a consolidated report will be submitted.  This registration process is expected to be available in early 2014. 

Some additional key points from CMS regarding the registration process:

  • Once the authorized official profile and entity profile are submitted, CMS will conduct a vetting process before final registration information is issued to the authorized user.  Because this vetting process may take up to 2 weeks, CMS encourages entities to complete this process as early as possible once the system is available.
  • Once the vetting process is completed and the authorized official receives access to the Open Payments system, the authorized official can nominate additional system users.  Entities may have up to 10 system users.
  • There are three roles available in the system – (i) officer role to manage the entity’s registration and approve additional system users; (ii) submitter role to submit data to CMS; and (iii) attester role for attesting to the report submission.  The officer and attester roles must be appropriate officers of the entity while the submitter role may include non-officers and third parties, such as vendors.  Additionally, the authorized official can fill all three roles, but there must be at least one additional user for the company.
  • If an entity does not have a D&B D-U-N-S number, CMS encouraged the entity to obtain one as soon as possible.  Entities with multiple D&B D-U-N-S numbers should include all numbers on the registration profile.    
  • Phone lines will be opened in early 2014.  Until then, entities can continue to use the CMS Help Desk email address for questions. 

CMS will hold a follow-up webinar on December 3, 2013 at 1 PM Eastern for additional questions regarding registration and data submission.  Participants are encouraged to submit questions for this meeting to by November 30, 2013.

Posted by Cooley

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