• Physicians
• Physician assistants
• Nurse practitioners
• Clinical nurse specialists
• Certified registered nurse anesthetists
• Certified nurse midwives

All payments, gifts and other transfers of value made to U.S. physicians and teaching hospitals:

• Consulting Fees
• Compensation for services other than consulting
• Honoraria
• Gift
• Entertainment
• Food and beverage
• Travel and lodging
• Research
• Charitable contributions
• Royalty or license fees
• Current or prospective ownership
• Compensation for serving as faculty or as a speaker for an unaccredited continuing education program/accredited CE program
• Grant
• Space rental or facility fee
• Debt forgiveness,
• Long term medical supply or device loan, and
• Acquisitions

All Applicable Pharmaceutical, medical device manufacturers and group purchase organizations (GPO) that fill the following criteria:

• Operates in USA
• Manufactures at least one “Covered Product” i.e drug or biological reimbursed by Medicare, Medicaid, or Children’s Health Insurance Program that requires a prescription (or physician’s authorization) to administer OR produces a device or medical supply that requires premarket approval or premarket notification by the FDA.

OR

• Purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply (as per criteria mentioned above) for a group of individuals or entities, but not solely for use by the entity itself.

• Companies with less than 10% revenue generated through “covered products” do not have to report all Transfers of Value, only the ones that are related to one or more covered drugs, devices, biologicals or medical supplies.
• Entities contributing to the manufacturing process of a covered product but have no business presence in the United States.
• Entities manufacturing raw materials or components only, which are not themselves covered products. However, entities that 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, do not qualify for this exemption.
• Hospitals, hospital-based pharmacies and laboratories that manufacture a covered product solely for internal use itself or by an entity’s own patients.
• Wholesalers or distributors who don’t hold the title of a covered product will not be subject to the reporting requirements, with the exception of those who are under common ownership with an applicable manufacturer and assist or support with respect to a covered drug, device, biological, or medical supply.
• Applicable manufacturer does not manufacture a covered drug, device, biological, or medical supply, with exception of manufacturing the covered product for another entity under a written agreement, 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.

Annual reports must be submitted to the Centers for Medicare and Medicaid Services through the online portal.

https://www.cms.gov/OpenPayments/Downloads/Affordable-Care-Act-Section-6002-Final-Rule.pdf

https://www.cms.gov/OpenPayments/About/Resources.html

https://www.cms.gov/OpenPayments/Program-Participants/Applicable-Manufacturers-and-GPOs/Applicable-Manufacturers-and-GPOs