Sunshine Law for Payment Disclosure: FAQs

FAQs by Andrew R. Van Haute, associate general counsel at the Advanced Medical Technology Association

Beginning August 1, 2013, medical and dental device manufacturers are required to report certain payments to physicians and dentists under the so-called “Sunshine Law.” The Sunshine Law does not restrict interactions or collaborations but requires disclosure. While health care providers do not need to file any reports, it is important for them to understand that their names will be reported to a database annually if they have interactions that trigger reporting requirements.
AdvaMed is a trade association that represents 80 percent of medical/dental device manufacturers, and all of our members will be required to comply. Our members view healthcare providers as critical partners in advancing the quality of care for patients through innovation, training and education. Our members are committed to helping AAE members and other providers understand required disclosures.

Why was the Sunshine law enacted?

The purpose of the Sunshine Law is to provide the patients with enhanced transparency into relationships healthcare providers may have with device manufacturers. It recognizes that the structures these interactions take, such as continuing education funding, consulting and other arrangements, have the potential to alter healthcare decision making. The concern is that payments or other transfers of value to providers can create a conflict of interest.

What is reportable under the law?

Reportable items under the Sunshine Law include payments for consulting, education, serving as faculty or as a speaker for continuing education, honoraria, research and grants – as well as other transfers of value such as gifts, meals, travel and entertainment – if they are worth $10 or more (or even items worth less than $10 if the total for a doctor adds up to $100 in a given year). The law also requires reporting of ownership/investment interests by covered providers.
How often is this data reported?
The data will be reported to the Centers on Medicare and Medicaid Services on a calendar year basis, and reports are filed on March 31 the following year. For 2013, the March 31, 2014 report will include payments made between August 1, 2013 and December 31, 2013.
Will I know if a manufacturer reports a gift/payment to me?
Providers can access their own data once it is made available by CMS on a secure online portal-sometime in mid-2014. However, you will need to register with CMS to view payments. The details of when and how to register have not been determined yet, but the AAE and AdvaMed members will be providing this information to you when it is available. Once annual payments are posted on the CMS website, providers will have 45 days to review data submitted under the Sunshine Law to ensure that it is correct or to initiate disputes before it is made public.

Who else can see the payments?
Starting September 2014, patients and other important stakeholders will be able to see these reported payments and transfers of value on a searchable public CMS website.

Because this is a new reporting program, there may be glitches as it is rolled out. However, it is important that AAE members who receive these sort of payments or transfers of value be aware of the program and that these payments will be a matter of public record.