As part of the Affordable Care Act ("ACA") enacted in 2010, The Physician Payments Sunshine Act ("Sunshine Act") requires the collection of data regarding payments and gifts made by medical device/pharmaceutical companies to physicians and teaching hospitals. Manufacturers and group purchasing organizations (GPOs) are also required to report certain ownership interests on the part of physicians and immediate families. Such data must be publicly available on a searchable Federal database starting in September 2014. It is the manufacturers' responsibility (not the physicians and hospitals) to report these payments, according to specific parameters specified by the Federal Centers for Medicare & Medicaid Services (CMS).
- August 1, 2013: Manufacturers are required to begin collecting payment information.
- January 1, 2014: CMS target date for launching its physician portal, whereby physicians can sign up to be notified when his/her individualized report is available for review.
- March 31, 2014: Manufacturers and GPOs report the payment/ownership data for August 1 – December 31, 2013 to CMS.
- June 30, 2014: CMS target date for providing physicians access to their individualized August 1 – December 31, 2013 report. Through the CMS portal, physicians will be able to contact manufacturers/GPOs if corrections are necessary.
- September 30, 2014: CMS date for release of the data via a publicly available and searchable website.
What Can You Do to Prepare?
SCAI members are urged to learn more about the requirements of the Sunshine Act. The AMA has a detailed site here: http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page
On the AMA's site, there are three recommendations you should consider doing now:
- Update your disclosures before August 1 (financial and COI disclosures required by employers, research sponsors, advisory groups, professional societies, etc.).
- Make sure your National Provider Identifier (NPI) information (if you have one) is correct https://nppes.cms.hhs.gov/NPPES/LoginPage.do?userType=PROVIDER
In particular, make sure that your basic information is correct and that your specialty is correctly noted. These data will be used by industry in reporting to the CMS database.
- Talk with your industry contacts. Let them know you would like the opportunity to review for accuracy information they will be submitting to the CMS database.
The Sunshine Act final regulation requires that companies report payment or transfer of value information according to the following categories:
- Consulting fees
- Compensation for services other than consulting
- Travel (including the specified destinations
- Charitable contribution
- Royalty or license
- Current or prospective ownership or investment interest
- Direct compensation for serving as faculty or as a speaker for a medical education program
The Sunshine Act final regulation requires that companies report the following data for each payment or transfer of value:
- Applicable manufacturer or GPO's name
- Recipient's name, specialty, business address, NPI, and state professional license number
- Amount and date of payment/transfer of value
- Form of payment/transfer of value (cash, in-kind, stock, dividend, profit or other ROI)
- Nature of payment
- The name of the related drug, device, biological or supply
• National Drug Code (NDC) of related covered drug/biological, if any
• For devices/med supply, name under which its marketed, or therapeutic area or
• "Non-covered" product
- Eligibility for delayed publication (research payments)
- Name of other recipient if not provided to the covered recipient directly (indirect payments)
- Payment to 3rd party at request of; or
- Designated on behalf of covered recipient
- Payments or transfers of value to physician owners or investors
- Statement providing additional context for the payment or other transfer of value (optional)
Where Can You Find Out More ?
Many resources are available, with more coming online each month.
*Note that this list will be updated regularly, and inclusion on this list is for information only and does not imply SCAI endorsement of the content
- CMS official website for OPEN PAYMENTS (Physician Payments Sunshine Act):
- CMS Fact Sheet for Physicians:
- CMS Guidance For Updating Your NPI (National Provider Identifier):
- CMS Fact Sheet for Teaching Hospitals:
- CMS Fact Sheet for Group Purchasing Organizations:
- American Medical Association:
The AMA website is comprehensive, including:
• An archived webinar on preparing for the Sunshine Act
• Summary of key provisions of the Sunshine Act
• Being transparent with patients answers to frequently asked questions,
• What is being reported ?
• What is exempt from reporting ?
• Who reports the information
• What is the purpose of the Sunshine Act ?
• How to ensure that submitted information is accurate ?
- AMA Sunshine Act Physician Brochure:
- AdvaMed (Advanced Medical Technology Association):
• Background on the Sunshine Act:
• Informational brochure for health providers: