Below is an easy reference guide for determining if a drug, device, biological, or medical supply manufacturer is an applicable manufacturer in accordance with Open Payments. Note that there are two potentially impacted types of manufacturers, as illustrated in the below chart.
Note that if the entity does not meet these characteristics, the entity is not determined to be an applicable manufacturer. But, the entity may still be an applicable GPO under Open Payments.
Applicable Type 1 Manufacturer
Applicable Type 2 Manufacturer
|Operate in the United States||Physical location within the United States or conducts activities within the United States (includes any territory, possession or commonwealth of the United States)|
Engages 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
Under common ownership with a Type 1 applicable manufacturers
Provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological or medical supply
Reimbursed by Medicare, Medicaid or Children’s Health Insurance Program
For drugs and biologicals, requires a prescription (or doctor’s authorization) to administer
For devices and medical supplies, requires premarket approval or premarket notification by the FDA
Teaching Hospital Listing
Refer to the Teaching Hospital webpage to access a listing of all teaching hospitals to be reported on (note that there are currently two versions of this list: one for 2013 reporting and one for 2014).
- Open Payments User Guide [August 2014] [PDF, 22MB]
- 2013 Open Payments Cycle: Teaching Hospital List [May 2013] [PDF, 797KB]
- 2013 Open Payments Cycle: Teaching Hospital List [May 2013, XLS] [ZIP, 104KB]
- 2013 Open Payments Program Year: Supplement to Teaching Hospital List [Oct 2013] [PDF, 674KB]
- 2014 Open Payments Cycle: Teaching Hospital List [October 2013] [PDF, 700KB]
- 2014 Open Payments Cycle: Teaching Hospital List [October 2013, XLS] [XLSX, 391KB]
- Page last Modified: 08/28/2014 10:58 AM
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