What is the Sunshine Act?
Enacted as part of the Patient Protection and Affordable Care Act (PPACA), the Sunshine Act is an attempt to increase transparency regarding relationships between physicians, teaching hospitals, manufacturers and the pharmaceutical industry.
Manufacturers of devices, drugs and biologicals participating in U.S. federal healthcare programs (Medicare, Medicaid and/or the Children’s Health Insurance Program) are required to track and report to the Centers for Medicare and Medicaid Services (CMS) certain payments or items of value paid or given to physicians and teaching hospitals.
Additionally, manufacturers and group purchasing orders (GPOs) participating in U.S. federal healthcare programs must report certain ownership interests held by physicians and their family members to CMS.
What kinds of payments are reported?
Manufacturers must report payments and transfers of value, regardless of if they are requested, to a physician or teaching hospital. Payments for research, including grants, must be reported. Other reportable payments include travel expenses, meals, gifts, entertainment, speaker’s honoraria, educational materials (i.e. textbooks and journal reprints etc.), participation in paid advisory boards and manuscript writing.
The name, date, NPI, state license number, specialty and address of the entity or individual receiving the payment must be reported by the manufacturer along with the amount of, reason for and type of payment (such as cash, stock, in-kind items etc.).
The Sunshine Act applies only to physicians licensed in the U.S. and excludes medical students, residents, office and support staff, nurses, advance practice nurses and physician assistants among others.
When does reporting begin?
On August 1, 2013, manufacturers began tracking reportable payments and transfers of value. By March 31, 2014, manufacturers will submit reports to CMS for August 1, 2013-December 31, 2013. CMS released this data on a public website on September 30, 2014.
The data is organized into three categories: general payments, research payments and physician ownership and investments.
This round of data includes payments made between August 1, 2013-December 31, 2013. It includes over $3.5 billion in distributions to almost 550,000 physicians and 1,360 teaching hospitals.
Are there any exemptions from reporting?
Yes there are some payments and transfers of value that are exempt from reporting including:
- Continuing medical education (CME) that complies with accredited or certified CME standards governing independence from industry where the applicable manufacturer does not directly pay or choose the speaker.
- A payment or transfer of value that amounts to less than $10, unless the aggregate annual amount exceeds $100.
- Food and beverages that are provided to all participants of large scale conferences or meetings.
- Product samples that are intended for patient use and not intended to be sold.
- Educational materials that are of direct benefit to patients or intended for patient use.
What is required of physicians?
Physicians are not required to report any payments or transfers of value to CMS themselves but they should understand the Sunshine Act provisions so that they are prepared to work with industry partners in order to provide the required information and in order to be prepared to dispute inaccurate reports.
What does CMS do with the reported information?
As of September 30, 2014, the information reported to CMS will be published on a public website (Open Payments).
CMS will refresh the 2013 data after addressing previously logged concerns.
Beginning next year, reports will be made public on an annual basis after physicians and teaching hospitals have the opportunity to review them. Payments or transfers of value for research are shown in a different section of the website than all other payments. Updates to a calendar year will be done each June.
Visit the CMS website to learn more.
I am a physician in private practice. How does the Sunshine Act affect me?
Payments or transfers of value including food and beverages brought to a physician’s office by a manufacturer’s representative, payment for speaking on behalf of a manufacturer and acting as a paid consultant must be reported. Private practice physicians may also receive payments for research from manufacturers that are reportable. Physicians should keep track of their payments and can ask manufacturers the value of any transfers. Payments and transfers of value can also be refused.
I am a physician at a teaching hospital. How does the Sunshine Act affect me?
It is possible that teaching hospitals may change or create rules for employee physicians regarding accepting payments from manufacturers. Physicians working in teaching hospitals should check with their institution for more information.
How do I know if a report is made about me?
CMS is required to provide physicians copies of manufacturer and GPO reports prior to them being made public. However, CMS will not alert physicians as to when the reports are public. Physicians are encouraged to register on the CMS website to receive alerts when the reports are up for review.
Because reporting will only happen annually, an extended period of time may pass between the payments and the reporting period. Physicians should keep their own records of payments and can ask manufacturers to alert them when a report is made.
Can I dispute a report about me?
Yes, physicians can dispute reports from manufacturers and GPOs. Physicians will have 45 days to review and dispute reports made about them. The dispute period for the September 30, 2014 publication began on July 14, 2014 and ended on August 27, 2014. Physicians must register for the Open Payments site in order to review reports and make disputes (please see below).
CMS is not responsible for resolving disputes and public reporting will still occur even if the dispute is not yet resolved. Reports that are disputed will be marked as such on the public website if not resolved within the dispute window. Manufacturers had until September 11, 2014 to resolve disputes for the September 30, 2014 publication.
Physicians can ask manufacturers about processes for reporting and resolving disputes.
Can I op-out?
The only way to opt-out is to refuse to accept any payments or transfers of value from manufacturers.
How can I get ready for the implementation of the Sunshine Act?
Registration for Phase 1 opened on June 1, 2014. In Phase 1, physicians and teaching hospitals can register for the CMS Enterprise Portal to access the Enterprise Management system.
Phase 2 registration opened July 14, 2014. This step allows physicians and teaching hospitals to review their reports on the Open Payments website and make disputes about incorrect or inaccurate information. While registration for Open Payments is technically voluntary, only those who are registered were able to review reports and make disputes prior to publication on September 30, 2014.
Where can I get more information?
CMS has developed a comprehensive website with information on the Sunshine Act provisions and on the Open Payments program that has been created to implement the law. Here physicians can find factsheets, frequently asked questions and answers and more information on the CMS tracking app.
The CMS website is also where physicians can register for periodic updates and for notifications on the availability of reports for review. Questions and requests for information can be sent to the HHS Help Desk at OpenPayments@cms.hh.gov. The American Medical Association also provides detailed information.