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Applicable Manufacturers

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.

 

Characteristic

Applicable Type 1 Manufacturer 
IF

Applicable Type 2 Manufacturer 
IF

Operate in the United StatesPhysical location within the United States or conducts activities within the United States (includes any territory, possession or commonwealth of the United States)
Activities

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

AND

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

Covered Products

Reimbursed by Medicare, Medicaid or Children’s Health Insurance Program

AND

For drugs and biologicals, requires a prescription (or doctor’s authorization) to administer

OR

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).