The Sunshine Act requires pharmaceutical and medical device companies to report to the federal government data about certain payments they make to physicians and teaching hospitals and certain physician ownership or investment interests. The Sunshine Act or Physician Payments Sunshine Act was enacted as a section of the Patient Protection and Affordable Care Act of 2010. The federal government often refers to the implementation of the Sunshine Act as Open Payments.
Congress passed the Sunshine Act in the interest of providing greater transparency in financial interactions between the health care industry and health care professionals. AbbVie supports the Sunshine Act and its goals because we recognize that transparency inspires public trust and confidence.
Manufacturers were required to begin tracking payments and other transfers of value provided to physicians and teaching hospitals as of August 1, 2013.
The Sunshine Act applies only to certain pharmaceutical and medical device companies such as AbbVie. These companies, however, must track and report payments and other transfers of value made to physicians and to teaching hospitals that receive Medicare graduate medical education or indirect medical education payments. For the purposes of the Sunshine Act, “physician” is defined as a physician, osteopath, dentist, dental surgeon, podiatrist, optometrist or chiropractor who holds an active state license to practice in the United States (including Puerto Rico). Starting 1/1/2021, additional healthcare providers will be reported including the following: physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, and certified nurse-midwives. CMS has published a list of teaching hospitals that are covered by the Sunshine Act on its website.
Physicians and teaching hospitals are sometimes referred to as “covered recipients” because payments and other transfers of value made to physicians and teaching hospitals are covered by the Sunshine Act.
The Sunshine Act requires reporting of most payments or transfers of value made to physicians and teaching hospitals. Such payments or transfers may include:
- Meals (including snacks, lunches and receptions)
Consulting, speaker fees and associated expenses
- Educational items (such as textbooks or anatomical models)
- Grants and charitable donations
- Clinical trial payments
- Research fees
- Royalties and license payments
Most payments and transfers of value provided by AbbVie to you directly or indirectly (or to someone else on your behalf) are reportable under the Sunshine Act unless an exception applies. You do, however, have the opportunity to decline acceptance of transfers of value such as a meal or educational item. For example, you have the option to decline food and beverage at an AbbVie-sponsored promotional speaker program or an in-office interaction. If you do not consume any food or beverages or accept any educational items or if you cover the cost of any meal or item provided, then AbbVie is not required to report a transfer of value under your name because you have not received any value.
For Open Payments/Sunshine Act Reporting, AbbVie is required to disclose the following information related to payments and transfers of value:
- Applicable manufacturer’s name
- Name of teaching hospital or physician
- Physician’s specialty
- Business address
- Amount of payment or other transfer of value
- Date of payment
- Form of payment (e.g. cash, in-kind items or services, stock)
- Nature of payment (e.g. consulting, food, travel, education)
- Name(s) of the related covered drug, as applicable
Additional information is available on the CMS website at: https://www.cms.gov/openpayments.
AbbVie tracks all payments or transfers of value regardless of the amount.
There are specific key (de minimis) thresholds for reporting for applicable manufacturers and GPOs. The Open Payments key (de minimis) thresholds for reporting are adjusted based on the consumer price index.
Please refer to the Sunshine/Open Payments website for additional details and guidance.
Information provided by AbbVie to CMS will be available for physician and teaching hospital review on the CMS website during the designated review period prior to the information being made public. Physicians and teaching hospitals must register with CMS to review this data.
Product samples not intended to be sold and intended for patient use are not reportable under the Sunshine Act.
How does AbbVie report meals provided to a group that includes individuals who are not covered by the Sunshine Act?
When a meal is provided to a group that includes both individuals who are covered by the Sunshine Act and individuals who are not covered by the Sunshine Act, AbbVie must determine and report only the value received by the individuals who are covered by the Sunshine Act. To make an accurate calculation of the value, AbbVie will generally calculate the per-person cost of the meal (total cost of the meal divided by number of overall participants) and report that per-person cost for each participant who is covered by the Sunshine Act (e.g., physicians).
In most cases, if you are paid by a third-party vendor for work that is conducted on behalf of AbbVie, then AbbVie must report your fee and any other transfers of value you receive.
The Sunshine Act does not change the types of payments and transfers of value that AbbVie currently reports to the IRS.