The Physician Payments Sunshine Act (PPSA), also referred to as the Open Payments program, was established under the Affordable Care Act and is intended to increase transparency in the financial relationships that physicians and teaching hospitals have with drug and medical device manufacturers.* Although the PPSA does not impose any penalties on physicians, surgeons should be familiar with the program and know what type of information regarding their transactions will be reported to the Centers for Medicare & Medicaid Services (CMS). Physicians also should be aware of their right to review the information reported to CMS under the PPSA and the steps they should take to challenge false, inaccurate, or misleading reports. This article describes the PPSA and provides information on how surgeons can prepare for its implementation.
Applicability of the PPSA
The PPSA requires manufacturers of covered drugs, devices, biologicals, and medical supplies to annually report to CMS any payments or transfers of value that they make to physicians or to teaching hospitals.† In addition, group purchasing organizations (GPOs) must report to CMS certain ownership interests that physicians and their immediate family members hold. PPSA reporting requirements include payments or transfers of value made to physicians in fellowship training, but not payments or transfers of value to medical residents.
Because the PPSA requirements apply to manufacturers and GPOs, physicians are exempt from the act’s penalties, and physicians generally are free from any requirements to take any sort of action. One exception is that applicable manufacturers and GPOs may require physicians to provide their National Provider Identifier (NPI) numbers, if the physicians receive payments or transfers of value from the manufacturers or GPOs.
Content of the reports
Manufacturers and GPOs must report to CMS if they provide specified payments or other transfers of value to physicians or teaching hospitals.‡ These transactions include:
- Payments or transfers of value exceeding $10. Some exclusions apply, including certified and accredited continuing medical education (CME), buffet meals or snacks at large-scale events, product samples intended for patient use rather than for sale, in-kind items used for the provision of charity care, discounts, the loan of a medical device for the short-term, transfers of value and payments made to a physician in return for non-physician services, items or services provided under a contractual warranty, a dividend or other profit distribution, or ownership or investment interest in a publicly traded security or mutual fund.
- Non-accredited or non-certified CME. Fees associated with serving as the faculty speaker or a physician attendee at a non-accredited/non-certified CME event must be reported.
- Educational materials given to the physician not intended to benefit the patient or not used to care for the patient. Medical textbooks that an applicable manufacturer or GPO provides to a physician must be reported.
- Meals at meetings where the manufacturer can identify the physician. If the value of the meal exceeds $10 and the individuals receiving the meal are “readily identifiable” at the time the meal is being provided, it is reportable. CMS excludes buffet meals, snacks, soft drinks, and coffee if the manufacturer makes them generally available to all participants at a large-scale event.
- Indirect transfers to a third party. Indirect transfers are reportable if the manufacturer “requires, instructs, or directs” the payment or transfer of value to be provided to a specific physician or group of physicians. Examples of indirect payments include payments or transfers to a third party on a physician’s behalf or a payment or transfer to an organization that the manufacturer then requires be provided to a specific physician within the organization. Indirect payments or transfers of value are excluded from disclosure if the applicable manufacturer is unaware of the identity of the physician recipient.
- Payments or transfers of value for research. The physician serving as the principle investigator as well as the institution performing the research is reportable.
Most of the information in the reports will be made available via a public, searchable website. Within a given time frame, physicians may challenge reports that are false, inaccurate, or misleading.
Key dates for PPSA reporting
Following are key dates to keep in mind regarding PPSA reporting.†
- August 1, 2013 to December 31, 2013: Manufacturers were expected to begin tracking payments to physicians and physician ownership information.
- January 1, 2014: Physicians could begin registering for a CMS online portal through which they will be able to review their reports. CMS began notifying physicians regarding the availability of their financial disclosures for review and correction through the Web portal.
- March 31, 2014: Manufacturers begin submitting their reports to CMS.
- June to August, 2014: It is anticipated that CMS will begin providing physicians with access to their reports for 2013 via the CMS portal during this time frame. Physicians will be able to contact manufacturers through the portal to correct errors or challenge the reports.
- September 30, 2014: CMS will begin releasing most of the information from the first reports on a publicly searchable website.
CMS will allow physicians to work with manufacturers and GPOs to review and correct information before it is made public.2 CMS will consolidate the reports from multiple manufacturers or GPOs so that each physician will only need to review one report. The portal will allow physicians to contact the manufacturers and GPOs that submitted the reports to dispute inaccurate, misleading, or false information. Physicians will have 45 days after CMS provides access to individual physicians’ industry reports via the online portal. If a physician and the manufacturer/GPO are unable to resolve the dispute in this time, they have an additional 15 days before the report is made public to try to achieve a resolution. CMS will not mediate such disputes between physicians and manufacturers/GPOs. If a resolution is not reached within the allotted time frame, the disputed information will be flagged, but the report will be posted on the public website. The review and correction period will start at least 60 days before the information is made public. Physicians will be able to seek correction or contest reports for two years after access has been provided via the portal to a report with disputed information, but CMS may only update data once annually from the current and previous year.
Preparing for the PPSA
Although the PPSA does not include specific requirements or penalties for physicians, the American College of Surgeons recommends that physicians take the following steps to monitor and verify any information that could be posted on a publicly searchable website:
- Familiarize yourself with the information that will be reported about physicians.
- Ensure that information in the NPI enumerator database is current and regularly updated. The manufacturers will use NPIs, along with other information, to identify physicians. To access the NPI Enumerator Database to verify your NPI information, go to https://nppes.cms.hhs.gov/NPPES/LoginPage.do?userType=PROVIDER.
- Confirm that your current organizational documents, employment agreements, compliance policies, and conflict of interest disclosure procedures are up-to-date.
- Ask the representatives of manufacturers and GPOs with whom you interact for permission to conduct a pre-submission review so that you can correct any information before it is sent to CMS.
- Maintain records of all payments and other transfers of value received from applicable manufacturers or applicable GPOs to double-check the reports that applicable manufacturer and GPOs will submit to CMS. A free mobile app, called the Open Payment for Physicians app, is available to help physicians keep track of payments they receive that may be reportable.
- Register with CMS for the online portal to review the reports that applicable manufacturers and GPOs will submit to CMS. Registration information is available at go.cms.gov/openpayments.
- Subscribe to the CMS PPSA listserv to receive updates regarding the program also at go.cms.gov/openpayments.
- Review the physician information that applicable manufacturers and applicable GPOs reported. Note: Physicians may only review this information by registering with the online portal.
- Work with applicable manufacturers and GPOs to challenge information submitted about the physicians that is inaccurate, misleading, or false.
Details on the PPSA/Open Payments program
For more information on how the PPSA affects physicians, review the CMS fact sheet.
For additional information on the PPSA and to monitor updates, visit http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/index.html.
The Open Payments for Physicians app allows physicians to capture and confidentially collect information on reportable transfers they may make with industry representatives so that they have access to data they may need to challenge any inaccurate information reported to CMS. The app can be downloaded to an Android device at https://play.google.com/store/apps/details?id=com.cms.physician&hl=en and to an Apple device at https://itunes.apple.com/us/app/open-payments-mobile-for-physicians/id667567467?mt=8.
*Government Printing Office. Patient Protection and Affordable Care Act. 2010. Available at: http://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf. Accessed January 21, 2014.
† Centers for Medicare & Medicaid Services. Fact sheet for physicians. Available at: http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Downloads/Physician-fact-sheet.pdf. Accessed January 21, 2014.
‡Centers for Medicare & Medicaid Services. Medicare, Medicaid, Children’s Health Insurance Programs; Transparency reports and reporting of physician ownership or investment interests. Final rule. Fed Regist. 2013;78(27):9457-9528.