What does the Sunshine Act Require?
Medical device and pharmaceutical manufacturers are required to track and report all payments and transfers of value provided to a covered recipient. A Covered Recipient is defined as: "a (1) Covered Recipient, other than a Covered Recipient who is an employee of an applicable manufacturer; or (2) a teaching hospital."
Who are Covered Physicians and teaching hospitals?
Physicians are defined within the act to include:
- Covered Recipients of medicine and osteopathy,
- optometrists, and
who are legally authorized to practice in the state in which they practice.
Teaching Hospitals will be identified by the Center for Medicare and Medicaid Services (CMS) each year prior to each reporting period. Most, if not all of our university customers will be identified as a teaching hospital.
What Payments or Transfers of Value are included?
All Payments or Transfers of Value $10 and above are required to be reported. Although the individual transaction threshold is $10, you are required to report ALL payments and transfers of value to ensure the aggregate $100 per person per year reporting threshold is met.
Payments and transfers of value including the following:
- Consulting fees
- Speakers Honoraria
- Charitable Contributions
- Royalty or License Payments
- Gifts (textbooks, journal reprints)
- Research (Clinical Studies)
- Compensation for other services
- Reimbursement for any of the above
What Payments or TOVs are excluded from reporting?
The following payments and TOVS are excluded from reporting subject to additional requirements
- Product Samples (must be reasonable quantities)*
- In-Kind charitable donations *
- Educational materials intended for patients (for example, 3-in-1 models)
- Loans of medical devices for evaluation (must be 90 days or less)
- Food and drink at conference booths
* Samples and in-kind charitable donations require a written confirmation of the customer that he or she will not charge the patient for the product.
How do I report Payments/TOVs made to Group Practices?
Any gift, educational item or other transfer of value provided to a group practice must be divided either evenly amongst all the Covered Recipients in the practice OR divided evenly by all the Covered Recipients who requested or will receive the transfer.
- A $100 gift to a 4 Covered Recipient practice will require reporting of $25 for each Covered Recipient.
- OR A $100 gift to a 4 Covered Recipient practice where only two Covered Recipients will receive the benefit or use the gift will require reporting of $50 for each participating Covered Recipient.
Journal reprints - Straumann has journal reprints as a part of our inventory that we utilize. Do these count as well?
Yes. If Straumann has purchased a subscription to a journal including reprints that we are providing to the Covered Recipient free of charge, then the value of that reprint is reportable. Think of it this way - if whatever it is we are providing to the Covered Recipient he or she would have to purchase for themselves (it has a commercial value) and its value is more than $10, then it is reportable.
Are meals reportable?
Yes, any meal provided to a Covered Recipient must be reported using Nexonia.
Reminder: meals remain prohibited for VT licensed clinicians and subject to certain restrictions for MA licensed clinicians.
How do I calculate the per person cost to report?
Take total dollar value of the meal including tax and tip and divide by total number of participants (including Covered Recipients and non- Covered Recipients)
Are refreshments provided at a tradeshow or other similar conference reportable?
No, light refreshments and beverages provided at large scale events where it is impractical to track do not have to be reported.
If you have other questions or topics you would like to see on the Straumann Sunshine Act page, contact us at: email@example.com.
Be sure to check back for periodic updates and additional information.