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Open for Business: CMS Open Payments System Begins in Phases

February 26, 2014

With the Open Payments System rollout, came the phased approach for data submission, requiring aggregate data in Phase 1 and detailed data reporting in Phase 2. 

The Centers for Medicare and Medicaid Services (CMS) recently announced that its Open Payments System is now open for registration and data submission. The system was created to receive data submissions from Applicable Manufacturers and Applicable Group Purchasing Organizations (GPOs) as required under Section 6002 of the Patient Protection and Affordable Care Act (popularly known as the U.S. Sunshine Act). With this announcement came the new concept of a two-phased approach.

Phase 1

Phase 1 is open from February 18 to May 31, 2014 and requires the following:

  • User registration for the “Authorized Official” within CMS’s Enterprise Identity Management System (EIDM) or Enterprise Portal, located here [1]
  • Submission of corporate profile information and “aggregate” 2013 payment data

Phase 2

Phase 2 will begin in May 2014 and will extend for a minimum of 30 days. Phase 2 requires the following:   

  • Finalization of Open Payments registration for the entity and user by providing additional information requested within the Open Payments System
  • Confirmation of the accuracy of the entity profile data submitted in Phase 1
  • Registration of additional users (beyond the Authorized Official)
  • Submission of detailed 2013 payment data
  • Attestation that the detailed 2013 payment data submitted is accurate

Phase 1—Registration and Aggregate Data Submission

During a CMS webinar held on February 25, the Phase 1 requirements were covered in detail. Additionally, step-by-step instructions are available on the CMS Open Payments website. The basic information necessary to register as an Authorized Official includes the following:

  • Name (first, middle, last, and suffix)
  • Email address
  • Social Security number (optional)
  • Date of birth
  • Home address, city, state, and zip code
  • Primary telephone number

Once this information is entered, the Authorized Official will be allowed to designate his or her User ID, password, and security or challenge questions specific to the Authorized Official’s user profile. Registration will then be complete, which will result in an email confirmation from CMS that includes both the User ID and a link to the CMS Enterprise Portal. The user will then have to sign in to the CMS Enterprise Portal to request application access for the Open Payments System as an Open Payments user, which initiates the identity verification process. Once the user’s identity has been verified, the user will be able to log in to the Open Payments System, thereby allowing access to instructions for initial data submission as well as other pertinent information, such as a Phase 1 data template.

Phase 1 aggregate data for the period of August 1, 2013 through December 31, 2013 must be submitted by March 31, 2014 via an email to OPdata@cms.hhs.gov. The company profile information and the aggregate data may be submitted by an individual other than the Authorized Official, provided that the Authorized Official’s EIDM User ID is included in the subject line of the email followed by the text “- Open Payments Email Submission for 2013 Reporting Entity and Payment Aggregate Data.” The attachment to the email submission must strictly comply with the sample template formatting requirements provided by CMS. Only one file attachment is allowed. The data components required within the sample template include the following:

  • Authorized Official’s EIDM User ID
  • Registering Entity information, limited to:
    • Entity’s legal name, doing-business-as name, and entity type
    • Website address for parent company
    • Business address and phone number
  • Aggregate information regarding 2013 payments and other transfers of value fitting into the categories below, with the related information.
     

Category 1
General Reporting Category

Category 2
Research Reporting

Category 3
Ownership or Investment Interests

Total Aggregate Amount

Total Aggregate Amount

Total Number of Ownership/Investment Interests

Total Number of Payments

Total Number of Payments

 

Total Number of Covered Recipients

Total Number of Covered Recipients

 


To clarify the required information listed above, we have included the following examples:

  • Total Aggregate Amount. This amount should be reported in dollars and cents and is the total of all payments and other transfers of value provided to covered recipients or physician owners/investors during the reporting period (e.g., if only two payments for $100 each were made during the reporting period, the Total Aggregate Amount would be $200).
  • Total Number of Payments. The total number (or count) of payments or other transfers of value is the total count of payments made to covered recipients during the reporting period (e.g., using the same example as above, the Total Number of Payments would be 2).
  • Total Number of Covered Recipients. The total number of unique or nonduplicated covered recipients or physician owners/investors who received the payments or other transfers of value during the reporting period (e.g., if both payments were made to the same covered recipient, the Total Number of Covered Recipients would be reported as 1. Additionally, if one payment was made to Dr. Smith and the other was made to Dr. Jones, the Total Number of Covered Recipients would be 2).
  • Total Number of Ownership/Investment Interests. The total number of instances of physician ownership or investment interests during the reporting period.


Once data is received by CMS via the OPdata@cms.hhs.gov email, the Open Payments Help Desk will review the submission to ensure compliance with CMS directives regarding format and will reply directly to the submitter to resolve any issues with formatting or file type.

Phase 1—Miscellaneous

Other miscellaneous topics discussed during the CMS webinar included timing for consolidated reporting, data for delayed publication, and submission of an assumptions document. CMS communicated that the Phase 1 reporting process does not allow for consolidated reporting. CMS further clarified that an Applicable Manufacturer intending to file consolidated reporting will be allowed to submit consolidated reporting during Phase 2; however, Phase 1 will require that each entity within an organization (meeting the definition of an “Applicable Manufacturer”) register individually and individually submit Phase 1 aggregate data.

With respect to data eligible for delayed publication, CMS clarified that the data must be included in both the aggregate data submitted as part of Phase 1 and the detailed payment data to be submitted in Phase 2.

Finally, any Applicable Manufacturer or Applicable GPO that elects to submit an assumptions document to supplement required reporting may do so as part of the Phase 2 reporting process.

No action is required at this time for covered recipients (physicians and teaching hospitals). Physician and teaching hospital registration will open after the Phase 2 submission process. CMS will soon issue more specific information regarding the dates for Phase 2 registration and data submission as well as information regarding when registration and review/correction will open for affected physicians and teaching hospitals, which will be no later than August 1, 2014.

CMS will upload a recorded version of its recent webinar on Open Payments registration and data submission here.

Contacts

If you have any questions or would like more information on any of the issues discussed in this LawFlash, please contact the authors, Scott Memmott (202.739.5098; smemmott@morganlewis.com) and Becky Osowski[2] (202.739.5009; rosowski@morganlewis.com), or any of the members of our Transparency Compliance team listed below. Additional information related to the U.S. Sunshine Act can be accessed at our Transparency Compliance Resource Center at http://www.morganlewis.com/topics/transparencycompliance.

Washington, D.C.
Kathleen McDermott
Michele L. Buenafe
Jonathan A. Havens


[1]. An “Authorized Official” is an executive-level officer (e.g., Chief Executive Officer (CEO), Chief Financial Officer (CFO), Chief Compliance Officer (CCO), president, vice president, or other Officer) of the Applicable Manufacturer or Applicable GPO.

[2]. Becky Osowski, Morgan Lewis’s Director of Healthcare Compliance, is a nonattorney compliance professional working to assist clients in developing and implementing practical and sustainable global compliant business practices.