CMS-10495. Justification of non-sub change (7-22-24)

To: Jamie Wilson

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: William N. Parham III

Office of Strategic Operations and Regulatory Affairs (OSORA)

Centers for Medicare and Medicaid Services (CMS)

Date: July 22, 2024

Subject: Non-Substantive Change Request – Registration, Attestation, Dispute Resolution and Correction, Assumptions Document and Data Retention Requirements for Open Payments (OMB No. 0938-1237; CMS-10495)

This memo requests approval of a non-substantive change to the approved information collection, Registration, Attestation, Dispute Resolution and Correction, Assumptions Document and Data Retention Requirements for Open Payments (OMB No. 0938-1237; CMS-10495).

Background

The “Registration, Attestation, Dispute Resolution and Correction, Assumptions Document and Data Retention Requirements for Open Payments” forms will be used by drug and device manufacturers to report payments or other transfers of value that are given to certain health care providers under the Open Payments Program. This data is then made publicly available on an annual basis. The system interface and operation is being updated to provide a better user experience and greater efficiency.

Overview of Requested Changes

The data collection system is migrating to a new platform and the user interface will have different formatting, improved navigation and optimized screen design. The following list provides an overview of the changes to the Open Payments System:

• A new log-in URL and streamlined process for registered users: https://openpayments.system.cms.gov/.

• Enhancements to user account management process.

• Modernized look and feel including updated color schemes and screen design.

• Enhancements to data submission screens, such as displaying real-time system messages like confirmations or error notifications with colored banners.

• General navigation and screen layout improvements, such as collapsable help text and organizing individual data entry sections into a workflow.

There is no change to the information being collected, the entities from whom it is being collected, the reason why CMS is collecting the information, the estimated burden for information collection, or how the information will be used once collected.