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Data Submission and Attestation

Under Open Payments, during each program year applicable manufacturers and applicable GPOs are required to submit data regarding payments or other transfers of value made to covered recipients, plus physician ownership, and investment interests. Late data submissions may be considered failures to report and could result in penalties.

 

Important Information Regarding 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 a two-phased approach for this first reporting year of this new program:

  • Phase 1 (February 18 through March 31) includes user registration in CMS’ Enterprise Portal (the gateway to CMS’ Enterprise Identity Management system (EIDM)) and submission of corporate profile information and aggregate 2013 payment data.
  • Phase 2 (begins in May and extends for no fewer than 30 days) includes industry registration in the Open Payments system, submission of detailed 2013 payment data, and legal attestation to the accuracy of the data.

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

 

Phase 1 Instructions

Step 1: New User Registration with CMS Enterprise Portal (EIDM Registration)

The Program Registration page provides details about the first step of Phase 1, CMS Enterprise Portal/EIDM registration. The second step of Phase 1 is described below.

 

Step 2: Aggregate Data Submission

After CMS Enterprise Portal/EIDM registration has been completed, the authorized official (or an authorized representative) will be directed to a web page that will explain the requirements for Phase 1 data submission. The authorized official should download the data submission instruction document and the sample template available on that page. The instruction document is not available on the Open Payments website, and is only accessible after CMS registration is completed. The sample template is now available here to provide general information on the data submission requirements and assist an entity with entering data; however, please note that the instruction document is still required for proper understanding and completion of the template.

 

In the sample template, you’ll see the below data elements for aggregate information regarding the applicable manufacturer’s or applicable GPO’s 2013 payment report. The bullets below the data field provide further explanation of the amounts that should be filled-in for each data element:

  • Category 1: General payments aggregate data:
    1. Total aggregate amount (in dollars and cents) of general payments or other transfers of value the applicable manufacturer or applicable GPO has provided to covered recipients or physician owners/investors during the reporting period (August 1, 2013 through December 31, 2013).
    2. Total number of payments or other transfers of value made.
    3. Total number of covered recipients (unique/non-duplicate) or physician owners/investors that were recipients of the payments or other transfers of value during the reporting period.

 

  • Category 2: Research payments aggregate data:
    1. Total aggregate amount (in dollars and cents) of research payments or other transfers of value the applicable manufacturer or applicable GPO has provided to covered recipients or physician owners/investors during the reporting period.
    2. Total number of payments or other transfers of value made.
    3. Total number of covered recipients (unique/non-duplicate) or physician owners/investors that were recipients of the payments or other transfers of value during the reporting period.

 

  • Category 3: Ownership or investment interests aggregate data:
    1. Total number of physician owners or investors, or their immediate family members, who held ownership or investment interest in the entity during the reporting period.

After registration has been completed, the authorized official or authorized representatives must submit the corporate profile information and aggregate 2013 payment data to CMS as instructed on the webpage and in the data submission instruction document. As explained in the instruction document, the CMS user ID must be noted in the subject line of the email sent to CMS containing the aggregate data.

 

When Phase 1 data has been submitted as instructed, the Open Payments Help Desk will reply directly to the submitter, confirming if the submitted data meets all requirements. If information is missing or improperly formatted, CMS will provide additional instructions on how to correct the data submission. 

 

More Phase 1 Data Submission Learning Resources

  • The Phase 1/Phase 2 Comparison Document summarizes the key activities taking place in Phase 1 and Phase 2, and provides a side-by-side comparison of each phase.
    • For example, the comparison table illustrates that in Phase 1 only limited corporate profile information and aggregate payment and investment interest data is to be submitted to CMS. However, in Phase 2 detailed 2013 payment and investment interest data will be submitted to CMS.
  • The Data Submission Instruction Document details all of the steps involved in Phase 1 data submission and is a handy resource to help users through this process. Updates made to this document include the following additions:
    • Step-by-step screenshot instructions for creating a pipe delimited CSV file in Microsoft Excel 2010. Note that in addition to the updates added to this document, these instructions are now available in video format (note: you will be asked to enter your name and email address to view the video);
    • Specified categories to be used when entering registering entity business type;
    • Specified required and optional data fields; and
    • An example of how to enter aggregate data, using a payment or transfer of value scenario.
  • Review the Events page to access the recording and presentation from the “Open Payments Phase 1 of 2 – Overview of Industry Registration and Data Submission” webinar, which discusses Phase 1 program registration and data submission requirements.

 

For data submission details, review the Open Payments User Guide or the sections shown below.  

 

The materials posted under these sub-headings are available to assist reporting entities with the Phase 2 detailed data submission process.

 

Data Submission Requirements and Timeline
Data Submission Resources
        Submission Data Mapping Document [Updated Dec 13/Jan 14]
        Bulk Data Upload Instructions [December 2013]
        XML Schema and XML Sample Files [Updated Dec 13/Jan 14]
        CSV Sample Files [Updated Dec 13/Jan 14]
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)?

Projected for May 2014

Projected for May 2014

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

The system will remain open for at least 30 days for Phase 2 detailed data submission

The system will remain open for at least 30 days for Phase 2 detailed data submission

Does not apply Does not apply
When does 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

Submission Data Mapping Document 
What it is: A mapping of data elements listed in the Submission File Specifications to the specific data fields in the XML and CSV sample files. Please note that as of late December 2013/early January 2014, this document has been updated with additional notes to add clarity on what should be followed if the schema/sample files differ from the Submission File Specifications.

Bulk Data Upload Instructions
What it is: 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
What is the XML Schema: The XSD (XML Schema Definition) document used to create and validate the XML data submission files for the three payment types. 

As of late December 2013/early January 2014, the following changes have been made in this updated document:

    • All elements with comma-separated values have been turned into groups of repeating elements: e.g., State and License numbers, product names, NDC.
    • A typo in an element name is corrected: "ownershipPhysicianSpecailty" has been changed to "ownershipPhysicianSpecialty."

What is the XML Sample Files: A sample of the exact format (in XML files) that will be used as a reference by reporting entities to upload data into the Open Payments system.

As of late December 2013/early January 2014, the following change has been made in these updated documents:

    • The Physician Specialty has been corrected to use the codes rather than the descriptions.

CSV Sample Files
What it is: A sample of the exact format (in CSV files) that will be used as a reference by reporting entities to upload data into the Open Payments system.

As of late December 2013/early January 2014, the following changes have been made in these updated documents:

    • The Physician Specialty has been corrected to use the codes rather than the descriptions.
    • All the space and hyphen/dash characters in the CSV headings have been converted to the underscore (_) character.
    • In the Research-category CSV header, "Home Payment ID" has been corrected to read "Home System Payment ID."
    • In the General Payment CSV sample file, a couple of issues with the sample data have been corrected.

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.