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United States
transparency obligations overview

Latest update: 22 October 2018 | Important Notes

Report Due Date

March 31

Authority

The Patient Protection and Affordability Care Act, Department of Health and Human Services, Centers for Medicare and Medicaid Services 42 CFR Parts 402 and 403

Who Must Report

Pharmaceutical and medical device manufacturers

Covered Recipients

Healthcare professionals (HCPs)
Healthcare organizations (HCOs)
(see details in text)

Pharmaceutical Companies and Medical Device Companies

What is reported:

All payments, gifts and other transfers of value made to U.S. physicians and teaching hospitals (with specified exclusions):

  • 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

For 2018, the Open Payment regulations requires that companies report individual transfers of value that are greater than $10.49. For 2019, the reporting threshold for individual transfers of value will increase to $10.79.

For 2018, where the annual aggregate amount for a single HCP or HCO is greater or equal to $104.90, all transfers of value, regardless of amount, are reportable. For 2019, the threshold for total annual amount of payments or transfers of value will increase to $107.91.

Data points to be disclosed:

  • Name and address of the recipient
  • National Provider Identifier (NPI) and state license of the recipient
  • Amount of the transfer of value
  • Date of the transfer of value
  • Form of the payment (cash/in-kind items, etc.)
  • Nature of the payment
  • Marketed name of the drug/device
  • Any other information that is requested

Covered Recipients Details

  • Healthcare professionals (HCPs), including doctors of medicine, doctors of osteopathy, dentists, podiatrists, optometrist, and chiropractors who are legally authorized to practice in any state
  • Healthcare organizations (HCOs): CMS publishes a list of teaching hospitals at least 90 days prior to the start of each reporting period. Applicable manufacturers may rely on this list for the entire reporting year.

How to Report

Annual reports must be submitted to the Centers for Medicare and Medicaid Services at portal.cms.gov/
Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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