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Data Submission and Attestation

To meet the requirements of Open Payments (the Sunshine Act), applicable manufacturers and applicable GPOs are required to submit data regarding payments or other transfers of value made to covered recipients, plus ownership and investment interests held by physician covered recipients each program year.

 

Registration and Data Submission for the 2013 Open Payments Program Year 

 

On February 18, Open Payments registration and data submission for applicable manufacturers and applicable GPOs opened with Phase 1 of a two-phased approach:

 

  • Phase 1 (closed; conducted February 18 through March 31, 2014): Included user registration for applicable manufacturer and applicable GPO authorized officials in the CMS Enterprise Portal (the gateway to CMS’ Enterprise Identity Management system (EIDM)), submission of corporate profile information, and aggregate information about their 2013 payment or other transfer of value and ownership/investment interest data. For more information on the instructions provided for Phase 1, review the steps to complete EIDM registration and the Phase 1 Instructions and Learning Resources document.
  • Phase 2 (closed; conducted June 1 through June 30, 2014): Occurred in two steps to facilitate file testing and final submissions for applicable manufacturers and applicable GPOs. 
    • Step 1 (closed; conducted June 1 through June 30, 2014): Authorized officials of applicable manufacturers and applicable GPOs were able to:
      • Complete Open Payments system registration for themselves and their reporting entity;
      • Confirm the accuracy of the reporting entity profile data submitted for Phase 1; and
      • Delegate roles and responsibilities by nominating system users to fill specific user roles.

During this period, system users in the role of submitter should have:

  • Performed test file uploads and submitted data files to validate the file structure and contents of the file (for more detail on this process, review the Phase 2 Instructions document); and
  • Utilized the error report produced by the Open Payments system, along with the Error Code File document which provided a description of the error code, the corresponding data element, and steps to avoid and correct each error, to fix any data errors (if any) in submitted files.

Once the test data files were successfully uploaded and validated at this step, industry users were able to move on to Step 2

    • Step 2 (closed; conducted June 9 through June 30, 2014): The Open Payments system allowed:
      • Submitters to perform final data submission (which included a series of checks to match the reported data to the appropriate physicians and teaching hospitals); and
      • Attesters to attest to the accuracy of their submitted detailed 2013 payment or other transfer of value data, or ownership/investment interest data.

All Phase 2 activities (Steps 1 and 2) should have been completed by June 30, 2014. Review the Phase 2 Instructions document for a detailed guide to Phase 2 timing and activities (this document is also available on the Program Registration page of the Open Payments website).

Registration Guidance for Affected Physicians and Teaching Hospitals

Review the Physician and Teaching Hospital web pages for details on the phased approach to physician and teaching hospital registration going on now.

 

Registration and Data Submission Resources for Industry

Video Tutorials: Three educational tutorials are available, addressing data submission resources, system registration, and data submission and attestation. Specifically, these tutorials cover the following material:

For Phase 2 detailed data submission details information, review the Phase 2 Instructions, the materials available in the following sections, and the Open Payments User Guide.

 

All of these resources are to be used by reporting entities during the Phase 2 detailed data submission process.

Data Submission Requirements and Timeline
Data Submission Resources
        Submission Data Mapping Document [Updated May/June 2014]
        Bulk Data Upload Instructions [December 2013]
        XML Schema and XML Sample Files [Updated April/May 14]
        CSV Sample Files [Updated May/June 2014]
        Error Code File Document [June 2014]

Industry Attests to Data

 

Data Submission Requirements and Timeline

Data Submission
  Applicable Manufacturers Applicable GPOs Physicians Teaching Hospitals
Who must submit the data to CMS? Yes, if they meet definition of an applicable manufacturer in 42 CFR 403.902 and have information to report Yes, if they meet definition of an applicable GPO as stated in 42 CFR 403.902 and have information to report Does not apply. Physicians do not have to submit data to CMS. Does not apply. Teaching hospitals do not have to submit data to CMS.
When does the Open Payments system open for 2013 detailed data submission (Phase 2)?

June 1, 2014

June 1, 2014

Does not apply Does not apply
When does the Open Payments system close for 2013 detailed  data submission (Phase 2)?

June 30, 2014

June 30, 2014

Does not apply Does not apply
When does the Open Payments system open for on-going program cycles? January 1 January 1 Does not apply Does not apply
When does the Open Payments system close for on-going program cycles? March 31 March 31 Does not apply Does not apply

 

Data Submission Resources – For Use in Phase 2 Detailed Data Submission

In late May, 2014, additional updates were made to the following documents as a result of extensive trouble-shooting and user acceptance testing of the Open Payments system:

The May/June 2014 Data Submission Document Changes Summary details the updates to these materials (see Section 3 for changes made in May/June; earlier sections describe changes made in previous updates).


Submission Data Mapping Document
The
Submission Data Mapping Document shows a mapping of the data elements listed in the Submission File Specifications to the specific data fields in the XML and CSV sample files. For full details of how this document has been updated since it was first posted, review the May/June 2014 Data Submission Document Changes Summary.

Bulk Data Upload Instructions
The
Bulk Data Upload Instructions are detailed instructions on how to use the XML schema, and XML and CSV sample files to bulk upload data.

XML Schema and XML Sample Files
The XSD (XML Schema Definition) document is used to create and validate the XML data submission files for the three payment types. For full details of how this document has been updated since it was first posted, review the
May/June 2014 Data Submission Document Changes Summary. Because the XML Schema is such a large file, the XML Schema Change Summary – With Sections can be used to track updates to the XML Schema with section numbers.

XML Schema (PaymentsSubmission.XSD) [Updated April 14] 

The XML Sample Files are the exact format (in XML files) that will be used as a reference by reporting entities to upload data into the Open Payments system. Again, review the May/June 2014 Data Submission Document Changes Summary for full details of how these resources have been updated since they were first posted.

XML Sample File: General Payments [Updated April/May 14]

XML Sample File: Research Payments [Updated April/May 14]

XML Sample File: Physician Owner/Investor [Updated April/May 14]


CSV Sample Files
The CSV Sample Files are the exact format (in CSV files) that will be used as a reference by reporting entities to upload data into the Open Payments system. For full details of how these documents have been updated since they were first posted, review the
May/June 2014 Data Submission Document Changes Summary.

CSV Sample File: General Payments [Updated May/June 2014]

CSV Sample File: Research Payments [Updated May/June 2014]

CSV Sample File: Physician Owner/Investor [Updated May/June 2014]

Error Code File document
The Error Code File document serves as the “go-to” reference for errors made during the data submission process. In the event an error is found in a data file uploaded to the Open Payments system, an error code will be displayed in the system-generated error report. Users should then refer to the Error Code File document for a description of the error code, the corresponding data element, and steps to avoid and correct each error.
 

Industry Attests to Data 

The final step in the data submission and reporting process is attestation. Applicable manufacturers and applicable GPOs must attest to the timeliness, accuracy and completeness of submitted data. Attestation applies to all original (first-time) submissions of data and also to any re-submissions of corrected data. CMS will consider the most recent, attested data from applicable manufacturers or applicable GPOs as the final submission. Data without an attestation will not be considered as reported. You may now review the attestation language prior to finalizing your submission and reporting. Note, you will not be able to make changes to this language.