Open Payments Reporting Entities
Reporting entities are required to report payments and other transfers of value they make to covered recipients, which includes ownership or investment interests that physicians or physicians’ immediate family members hold with the reporting entity.
Reporting entities report this information to the Centers for Medicare & Medicaid Services (CMS) on an annual basis, and it becomes publicly available via the Open Payments data site.
Is Your Organization Required to Report Data?
The charts below will tell you if your organization needs to report payments or transfers of value to Open Payments.
Open Payments expanded in 2021. Visit the Changes for Reporting Entities page to learn how the expansion could affect you.
Open Payments General Resources
Resources for Reporting Entities
Data Submission and Attestation
You’re an Applicable Manufacturer If…
|Criteria||Type 1 Manufacturer||Type 2 Manufacturer|
|Place of Operation||Your physical location and/or your activities are within the United States. This includes any territory, possession, or commonwealth of the United States.|
|Activities||You engage in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological or medical supply.
This includes distributors or wholesalers that hold title to a covered drug, device, biological, or medical supply.
|You exist under common ownership with a Type 1 applicable manufacturer
You provide assistance or support to such an entity with respect to the production, preparation, propagation, compounding, sale, or distribution of a covered drug, device, biological, or medical supply.
|Covered products||You produce at least one product reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program (CHIP).
If the product is a drug or biological, and it requires a prescription (or physician’s authorization) to administer
If the product is a device and it requires premarket approval or premarket notification by the Food and Drug Administration (FDA).
You’re an Applicable GPO If…
|Criteria||Group Purchasing Organization (GPO)|
|Place of Operation||Your organization’s physical location is within the United States and/or if you conduct activities within the United States. This includes any territory, possession, or commonwealth of the United States.|
|Activities||You purchase, arrange, or negotiate the purchase of a covered drug, device, biological or medical supply for a group of individuals or entities, but not solely for use by the entity itself.|
|Covered Products||At least one product is reimbursed by Medicare, Medicaid or CHIP
If the product is a drug or biological and it requires a prescription (or a physician’s authorization) to administer
If the product is a device and it requires premarket approval or premarket notification by the FDA.
How Does Your Organization Participate in Open Payments?
To participate in Open Payments as a reporting entity, you will need to:
- Register in the Open Payments system.
- Collect and submit data into the system.
- Verify and attest to the accuracy of the data.
- Respond to disputed payments.
All Open Payments program cycles consist of a full calendar year during which data must be collected and reported to CMS. It is then published on the Open Payments data site each year on or by June 30.
More information, including the Open Payments user guide and a complete list of quick reference guides, can be found on the Resources page.