CORPORATE CITIZENSHIP – PAYMENTS TO PHYSICIANS
PHYSICIAN PAYMENTS SUNSHINE ACT AT A GLANCE
The Physician Payments Sunshine regulation (“Sunshine” or “Open Payments”) requires manufacturers of products reimbursed by Medicare or Medicaid (so-called “covered products”) and certain of their affiliates that operate in the United States to annually report to the Centers for Medicare and Medicaid Services (CMS) information about payments or other transfers of value they provide to U.S. physicians and teaching hospitals (collectively, “covered recipients”).
Any payment or transfer of value from a manufacturer operating in the United States to a covered recipient must be reported. Some examples are:
- Meals provided both in and out of the physician’s office, if the physician consumes any of the food or beverages (coffee and snacks at a conference are exempt)
- Physician educational items that do not directly benefit the patient, including textbooks and scientific journal reprints
- Payments for speaking engagements
The information will be posted on CMS’s Enterprise Portal.
PHYSICIAN PAYMENTS SUNSHINE ACT FAQS
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WHAT IS SUBJECT TO REPORTING UNDER SUNSHINE/OPEN PAYMENTS?
Any payment or transfer of value from a manufacturer operating in the United States to a covered recipient must be reported. Some examples are:
- Meals provided both in and out of the physician’s office if the physician consumes any of the food or beverages (coffee and snacks at a conference are exempt)
- Travel expenses and travel destination
- Physician educational items that do not directly benefit the patient, including textbooks and scientific journal reprints
- Consulting fees, including payments for serving on an advisory board as well as consulting on product development
- Payments for speaking engagements
- Certain grants or other indirect payments to third parties, if the manufacturer learns within a specified period of time that the organization used any portion of the grant to pay a physician for any reason
- Research payments (e.g. payments to clinical trial sites)
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TO WHOM AND HOW OFTEN DOES EISAI SUBMIT SUNSHINE REPORTABLE PAYMENTS?
Each year, by March 31, we’re required to provide CMS with our annual disclosure report covering the previous calendar year.
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WHERE WILL THIS INFORMATION BE REPORTED AND HOW WILL IT BE PRESENTED?
The information will be posted on CMS’s Enterprise Portal and will be available for review by those physicians and teaching hospitals registered in the portal prior to public disclosure. The review and dispute period for each program year will start at least 60 days before the information is to be publicly published. During a 45-day review period, covered recipients will be able to dispute any specific reported payments and attempt to resolve the dispute with the reporting manufacturer outside of the system. CMS will allow an additional 15 days to resolve disputes after the 45-day review period. If the dispute isn’t resolved, the public website will list the manufacturer’s information but mark it as “in dispute.”
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WILL MY PATIENTS HAVE ACCESS TO MY REPORTABLE PAYMENTS?
Yes. CMS will make the data publicly available after the 60-day review and dispute period.
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AS A PHYSICIAN, CAN I REFUSE TO HAVE MY INFORMATION REPORTED?
No. We’re required to report any payments or other transfers of value to covered recipients. Any misrepresentation or submission by Eisai of any false, incomplete or misleading information may be punishable as a criminal act under law.
You may, however, refuse to accept any payments or transfers of value from Eisai (for example, a meal during in-office/out-of-office presentations such as Lunch & Learns and Speaker Programs.) We won’t be obligated to report your name if you don’t partake in the meal.
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WHAT IS THE REPORTING FORMAT?
CMS has categorized payments into two separate buckets: Research Payments (i.e., clinical trial-related site payments) and General Payments (i.e., all other payments not related to clinical trial site payments). Eisai will disclose payments in the format specified by CMS for General Payments and Research Payments.
For General Payments, we must report the following information:
- Name of the covered recipient receiving payment
- Primary business address of the physician or teaching hospital
- For physicians, their area of specialty, National Provider Identifier (NPI) number and state license number
- Amount of the payment or other transfer of value
- Date of the payment or other transfer of value
- Form of the payment or other transfer of value (using one of four descriptors: cash, in-kind item, stock, dividend)
- Nature of the payment or other transfer of value (using one of 15 descriptors, such as consulting fee, food and beverage, education and so forth)
- Name of any Eisai products related to the payment or other transfer of value and National Drug Code (NDC), if applicable
- An indication as to whether the interaction is related to research for which there is delayed public disclosure. (Manufacturers may request that research-related payments not be posted on the public website until four years after the payment is made or the FDA approves the product, whichever is earlier, to protect confidential information about the scope of the research.)
- If the payment or other transfer of value was made to a third party at the request of or designated on behalf of the physician or teaching hospital, the name of the entity or individual
For Research Payments, we must report the following information:
- Name of the physician, teaching hospital or non-covered recipient receiving payment
- Primary business address of the recipient
- Amount of the payment or other transfer of value
- Date of the payment or other transfer of value
- Form of the payment or other transfer of value (using one of four descriptors: cash, in-kind item, stock, dividend)
- Name of any Eisai products related to the payment or other transfer of value and National Drug Code (NDC), if applicable
- An indication as to whether the interaction is related to research for which there is delayed public disclosure. (Manufacturers may request that research-related payments not be posted on the public website until four years after the payment is made or the FDA approves the product, whichever is earlier, to protect confidential information about the scope of the research.)
- Name of the study for which the payment was made
- Name and identifying information for the principal investigator(s)
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WHO SHOULD I CALL AT EISAI IF I HAVE QUESTIONS ABOUT THE INFORMATION EISAI REPORTED TO CMS?
For questions related to reportable information, navigating the CMS Portal, initiating a dispute, etc., please refer to the Open Payments section on the CMS website.
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WHERE CAN I REFER MY PATIENTS IF THEY HAVE QUESTIONS/CONCERNS REGARDING SUNSHINE?
The CMS website provides an overview of Sunshine/Open Payments and explains the purpose of such transparency.