The Physician Payment Sunshine Act

"Open Payments"

Information for PHSMC Physicians

Click to view letter from Neal Thomas, Chair, Conflict of Interest Review Committee

The Physician Payment Sunshine Act, part of the Affordable Care Act, was passed by Congress in 2010. Under the Sunshine Act, manufacturers of drugs, medical devices, biological, or medical supplies, and group purchasing organizations, will be required to report all financial transactions/transfers of value to physicians and teaching hospitals. Ownership and investment interests of physicians and their immediate family members in these companies are also reportable. Manufacturers will be required to submit the compiled reports to the Center for Medicare and Medicaid Services (CMS) on an annual basis. The information will then be made available on a public, searchable website. The program implementing the requirements of the Act is called "Open Payments" and will be administered by CMS.

Physicians and teaching hospitals do not have any reporting obligations under this Act. However, payments and other transfers of value they receive from manufacturers will be publicly reported. Therefore, it is important that these reports are accurate and complete. Inaccurate reports could have an adverse effect on a physician's reputation. Each physician is the only person who can access and initiate procedures to correct errors in reports pertaining to them, before the reports are published. Penn State has no opportunity to review or petition for correction of any of these reports regarding individual faculty members.

Starting July 14, 2014, physicians are urged to register with the website to receive notice of reports. CMS will not initiate direct contact with physicians; registration is essential in order to receive notification. Physicians will have the opportunity to review and dispute information (by August 27th) before it is published on the public website.

Recommendations for reviewing and correcting "Open Payments" Reports:

  • Become familiar with the information that will be reported about you
  • Keep records of all payments and other transfers of value you receive from applicable manufacturers or applicable GPOs.
  • Register with CMS and subscribe to their listserve to receive updates regarding the program.
  • Look at the information manufacturers and GPOs submitted on your behalf.
  • Work with manufacturers and GPOs to make sure the information submitted about you is correct.

Review, Dispute and Correction Process

Pre-submission Review Process

  • The manufacturer or GPO can, but are not required to, give the physician, teaching hospital, or physician owner/investor the chance to see their information before sending it to CMS. This process is voluntary. CMS will not oversee pre-submission reviews.
  • If you ask for a pre-submission review, there is a better chance that the information sent to CMS about you is accurate and complete.

CMS Review Process

Once the manufacturer or GPO has submitted the data to CMS, the process is as follows:

  • CMS will give physicians and physician owners/investors 45 days to review and work with the manufacturers or GPOs to correct the information. After those 45 days, manufacturers or GPOs will have an additional 15 days to submit corrections based on any disputes identified by physicians, and physician owners/investors. The review and correction period starts at least 60 days before the information is made public.
  • During the review and correction period, physicians and physician owners/investors can dispute information about them that they do not think is correct.
  • If data is disputed, CMS will notify the manufacturers or GPOs that some of their data has been disputed, but will not mediate the dispute directly. Manufacturers or GPOs should work with physician and physician owner/investor to correct the information.
  • Once the dispute is resolved, the manufacturers or GPOs must send CMS a revised report for the correct data and re-attest that it is correct.
  • If the manufacturer or GPO cannot resolve the dispute with the physician or physician owner/investor and correct the data in the initial 45 days or subsequent 15 days, they should continue trying to find a resolution.

This review, dispute and correction process will impact publication as follows:

  • While the review and correction system will be open year-round, only the data corrections noted during the 45-day review and correction period, and subsequent 15-day dispute resolution period, will be updated before publication.
  • CMS will update data from the current and previous year at least once annually, in addition to the initial data publication that followed the data submission.

Frequently Asked Questions (FAQs)

Who does the Sunshine Act impact?

  • Manufacturers
    • Manufacturers of pharmaceutical/biologic products or medical devices that are reimbursed by the U.S. federal government, whether through Medicare, Medicaid, or state children's health insurance.

  • Group Purchasing Organizations

  • Teaching Hospitals

  • Physicians

 The Sunshine Act applies to payments made to:

  • Doctors of Medicine
  • Doctors of Osteopathy
  • Doctors of Dentistry
  • Doctors of Dental Surgery
  • Doctors of Podiatry
  • Doctors of Optometry
  • Doctors of Chiropractic Medicine

. . . Who have an active license to practice.

  • Other healthcare professionals are not included.
  • Exclusions:
    • Employees of a manufacturer
    • Residents
    • Medical Students

What are manufacturers Required to Report to CMS?

  •  Any type of payments or transfers of value to physicians including:
    • Consulting fees
    • Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program
    • Honoraria
    • Gifts
    • Entertainment
    • Food and beverage
    • Travel and lodging
    • Education
    • Research
    • Charitable contributions
    • Royalty or license
    • Current or prospective ownership or investment interest
    • Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program
    • Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program
    • Grants
  • These payments include:
    • Direct payments or transfers to the physician
    • Third party payments or transfers
    • Indirect payments or transfers
    • Ownership & Investment Interest (including immediate family members of physicians)

What is the expected timeline implementation of the Act in 2013-2014?

  • August 1, 2013: Industry entities began collecting the required data.
  • July 2014: Physicians permitted to register on CMS Open Payments website. This will allow them to review CMS reported information.
  • July 14, 2014 to August 2, 2014 and August 15, 2014 to September 10, 2014: Physicians can request their individual report, view it and flag disputes after completing registration. Disputes must be initiated by August 27th to have potentially erroneous data flagged in the initial public release.
  • September 11, 2014 to September 23, 2014: Correction period
  • September 30, 2014: First public reports
  • December 31, 2014: Last day to file dispute for 2013 report data.

If I receive payment from a separate entity on behalf of a pharmaceutical manufacturer, is that reportable?

  • Yes, manufacturers will be required to report any indirect payments or transfers made at their "direction, instruction or requirement".

Resources:

(The above summary includes only the highlights of the program most important to PSHMC physicians and faculty members. For more detail, consult any one of the following)

  1. Patient Protection and Affordable Care Act. 111 Congress HR 3590 2010:111- 148. 2010. (http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf)
  2. American Medical Association: Physician Financial Transparency Reports (Sunshine Act) http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page
    • Note: Please review "Top Tips to Ensure Accurate Reporting" for information on your role, as a physician, in ensuring accurate reporting. This site also provides a link for a free smartphone app that you may download to track reportable transfers.
  3. Centers for Medicare and Medicaid Services: National Physician Payment Transparency Program: OPEN PAYMENTS. http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/index.html
  4. Send questions to OpenPayments@cms.hhs.gov