Understanding the Sunshine Act and Open Payments Program
Physician Payments Sunshine Act (Open Payments Program)
The Physician Payments Sunshine Act established the Open Payments Program administered by the Centers for Medicare and Medicaid Services (CMS). The program is designed to provide greater transparency around the financial relationships of manufacturers, physicians and teaching hospitals. For the most up-to-date information, visit CMS's Open Payments Program page.
Frequently asked questions
What is the Physician Payments Sunshine Act?
As mandated by the Affordable Care Act, the law requires medical device and pharmaceutical companies to disclose any “transfers of value” made to physicians or teaching hospitals through a federal database that began in 2014. Transfers of value include payments, gifts and any ownership or investment interests. Specifically, the new federal transparency regulations require:
It is important to note, however, that the regulation only applies to medical device and pharmaceutical companies and does not require any action on the part of the physician.
Data collection began on March 31, 2014. Under the guidelines, the following information must be reported:
Prior to publication, physicians were given 45 days to review the information and make necessary corrections. The companies then had 15 days to amend the report. If the dispute could not be resolved within the specified time frame, CMS published the report with a notation that the information has been disputed. Payments under $10 were not be required to be reported unless those payments total $100 or more in any given year. Companies are not required to report payments made to a speaker at a CME program if certain conditions are met.
Who does the reporting?
The Sunshine Act requires that data on payments and gifts made to physicians and teaching hospitals by medical device and pharmaceutical companies (manufacturers) and group purchasing organizations (GPOs) be publicly available on a searchable federal database, called the Open Payments Program website, which started in September 2014.
While the burden of data collection and reporting requirements falls on manufacturers and GPOs—not physicians and teaching hospitals—physicians are encouraged to voluntarily review and dispute manufacturers' and GPOs’ data before it is submitted to the CMS, and, at the very least, before it is posted on the CMA national website.
What is to be reported?
Applicable manufacturers of at least one covered drug, device, biological or medical supply must report all payments of $10 or more or other transfers of value provided to covered recipients, regardless of whether any particular payment or other transfer of value was related to a covered drug, device, biological, or medical supply. Applicable manufacturers will be required to categorize all reportable payments as falling within one of the following natures of payment:
At health care conferences, companies must report the per-person value of meals given to physicians who take the meals, but have no responsibility to report on buffet meals or other foods/beverages made available to all participants in a conference.
All SIR educational meetings, involving applicable manufacturers and applicable group purchasing organizations are affected by the Physician Payments Sunshine Act.
Accredited vs. non-accredited SIR programs: CMS believes "that since this type of education program does not require the same safeguards as an accredited and certified program, payments or transfers of value should be reported as required for any other payment or other transfer of value." If the payment or other transfer of value is made indirectly, it will be subject to the same reporting requirements for all indirect payments.
If you have any specific questions about how this program will impact interventional radiologists or SIR programs, please contact Susie Evenden at (703) 460-5586.