Open Payments Reporting Entities

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.

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You’re an Applicable Manufacturer If…

CriteriaType 1 ManufacturerType 2 Manufacturer
Place of OperationYour physical location and/or your activities are within the United States. This includes any territory, possession, or commonwealth of the United States.
ActivitiesYou 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
 

AND


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).
 

AND


If the product is a drug or biological, and it requires a prescription (or physician’s authorization) to administer
 

OR


If the product is a device and it requires premarket approval or premarket notification by the Food and Drug Administration (FDA).

Exemptions:

  • Applicable manufacturers and GPOs with less than 10 percent of revenues from covered products do not need to report all payments or other transfers of value. They are, however, required to report payments or other transfer of value that are related to one or more covered drugs, devices, biologicals or medical supplies
  • Foreign entities that may contribute to the manufacturing process of a covered product are exempt if they have no business presence in the United States.
  • Entities that only manufacture raw materials or components, which are not themselves covered products, are not required to report unless the entity are under common ownership with an applicable manufacturer and assist such manufacturer with the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply.
  • Entities such as hospitals, hospital-based pharmacies, and laboratories are exempt if they manufacture a covered product solely for use by or within the entity itself or by an entity’s own patients.
  • Wholesalers or distributors that do not hold the title of a covered product are not subject to the reporting requirements, unless they are under common ownership with an applicable manufacturer and provide assistance or support with respect to a covered drug, device, biological, or medical supply.
  • If an applicable manufacturer does not manufacture a covered drug, device, biological, or medical supply (except pursuant to a written agreement to manufacture the covered product for another entity), does not hold the FDA approval, licensure or clearance for the product, and is not involved in the sale, marketing or distribution of the product, then the manufacturer is only required to report payments or other transfers of value related to the covered product. This is described in the regulatory text at §403.904(b)(4).

You’re an Applicable GPO If…

CriteriaGroup Purchasing Organization (GPO)
Place of OperationYour 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.
ActivitiesYou 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
 

AND


If the product is a drug or biological and it requires a prescription (or a physician’s authorization) to administer
 

OR


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:

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.

Page Last Modified:
10/18/2024 12:32 PM
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