We are pleased to announce that the Open Payments System is now available for reporting. Applicable manufacturers and group purchasing organizations (GPOs) (collectively referred to as reporting entities) may register and/or recertify and begin submitting Program Year 2022 data. All data submission activities are completed within the Open Payments System. To access the Open Payments System, you must be registered within the Centers for Medicare & Medicaid Services (CMS) Enterprise Portal. If your organization has reportable Open Payments data, registration in the Open Payments system is required in order to submit data to CMS. If your organization is already registered, please remember to recertify; yearly recertification is required for reporting entities with reportable data. The Open Payments system no longer accepts records for Program Years 2013 through 2016. If you have not accessed your account in the last 180 days, you will need to call the Open Payments Help Desk at 1-855-326-8366 (TTY: 1-844-649-2766) to reactivate your account. (Back to top)
Reporting entities may begin data submission activities.
Program Year 2022 data submission opens today, February 1, 2023 and will close on Friday March 31, 2023.
In order for Program Year 2022 data submission to be considered timely, both submission and attestation must be completed by 11:59 p.m. (ET) on March 31, 2023. Any records submitted or attested after this deadline are considered late and therefore noncompliant with program requirements. Noncompliant records may result in civil monetary penalties. CMS recommends completing the submission process as early as possible in the submission window to avoid slower system times at the end of the submission window, as this will not constitute a valid mitigating circumstance for a late submission. (Back to top) System Enhancements – Hard Error for Device Validation The Open Payments system now generates a hard error messages for failed validation of device or medical supply product information. On General and/or Research payment records, the system generates a hard error if the Medical Device or Medical Supply Name and Primary Device Identifier (PDI) combination is not valid. Reporting entity users must correct the field(s) for successful validation before proceeding with the submission process. The hard error validation affects both new submissions and resubmissions of payment records for General and Research payment records. The list of Medical Device or Supply Name and Primary Device Identifier CSV reference file and Instructions Document are available on the Open Payments Resources Page for Reporting Entities page. For successful validation, reporting entities should use the PDI and Medical Device or Medical Supply Name combination as provided in the reference dataset. This dataset is updated annually in January with the latest available data from the U.S. Food & Drug Administration (FDA). Open Payments Resource Updates The Open Payments resources are updated to reflect the new reporting requirements and note new system behaviors due to system enhancements. The updated resources are available on the General Resources and Resources for Reporting Entities pages. It is recommended that you have the most recent versions of the Open Payments resources, including but not limited to: Open Payments User Guide for Reporting Entities, Data Submission Mapping Document, Quick Reference Guides, and the Error Code Key document. (Back to top) In preparation for Program Year 2022 data submission and Program Year 2023 data collection, these suggestions may be helpful for meeting the requirements for timely, accurate, and complete reporting to Open Payments. Review Content Remember to verify your data for accuracy before finalizing your submission. While submitted information may meet the requirements for data type, format, and field size, that does not necessarily mean that the contents of the fields are valid. Simple errors such as a misspelling or abbreviation in a product name can lead to system validation or matching failure. Review your submission to ensure that the appropriate nature of payment categories have been selected. When deciding on a nature of payment category, it may be helpful to consider the following: - Choose the Nature of Payment category that most closely describes the reportable payment or transfer of value.
- The context field can be used to include additional information. The information included in this context field is published on the Open Payments website.
- The assumptions statement can be used to explain any methodologies used for selecting nature of payment categories. This statement is not published and is used to explain any methodologies or unusual submissions to CMS, especially for topics such as ownership and investment interest valuation.
Submit Early CMS recommends beginning the reporting process early in the submission window in order to allow time for addressing any errors or issues. Starting early helps to avoid longer upload times that may occur towards the end of the submission window when the system is being used most heavily. In the event that records fail validation, it may take additional time to edit and resubmit. Reporting entities should plan accordingly because late attestation due to failed validation is not an exemption to the requirement for timely reporting. In order for data submission to be considered timely, both data submission and attestation must be completed by the end of the reporting window, Friday, March 31, 2023. Program Year 2023 Data Collection Reminder: Teaching Hospital Context Field As you collect your PY2023 data, keep in mind the new requirement for submitting additional context with teaching hospital records. This will be a free form text field that the reporting entity should populate with any information it believes is relevant for the teaching hospital to understand the context of the record, such as the corresponding department of the hospital or a check number. The purpose of this field is to alleviate teaching hospital disputes due to a lack of clarity around research payments attributed to them. The contents of this field will not be included in the publicly released dataset. (Back to top) Submit questions to the Help Desk via email at openpayments@cms.hhs.gov or by calling 1-855-326-8366 (TTY Line: 1-844-649-2766). Beginning today, February 1, 2023, the Open Payments Help Desk is operating on extended hours from 8:30am – 7:30pm (ET) Monday through Friday, excluding federal holidays. The Help Desk refers media inquiries to CMS' Press Office for response. (Back to top) Creating Public Transparency of Industry-Provider Financial Relationships.
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