Guidance for clinical faculty on the PPACA "sunshine provisions"
The "sunshine provisions" of the Patient Protection and Affordable Care Act (PPACA) require that manufacturers of devices, drugs, and other items that must be prescribed or ordered report their payments to physicians and teaching hospitals. These payment data will be published on the Centers for Medicare and & Medicaid Services (CMS) Open Payments web site, and will represent one segment of a clinical faculty member's digital reputation. It is important that our clinical faculty understand the reporting process and its ramifications, and what they should do to ensure that any payments they are reported as having received are, in fact, correct.
What information is reported to CMS?
Schedule for reporting, review, and posting of data
Registration, review of your payment data, and disputes
How published payment data will be used
How to prepare for the Open Payments process
The Open Payments mobile app
Definitions from the sunshine provisions
Links to additional information
"Payments,” including both cash transactions and transfers of value (such as meals or sponsored travel), that exceed $10. Manufacturers also must report aggregate payments to a single payee over $100 in a calendar year. Payments are reported in the following categories:
- Consulting fees
- Compensation for services other than consulting, including serving as faculty or as a speaker at a non-CME event
- Food and beverage (except when provided buffet-style, at large-scale events where the recipients are not identified)
- Travel and lodging
- Charitable contributions (e.g., if in lieu of compensation, your earnings be paid to a charitable organization)
- Royalties or licenses
- 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
- Direct compensation from a Manufacturer for serving as faculty or as a speaker for an accredited or certified continuing education program (see SOM document on the sunshine provisions and CME)
- Grants - these payments should be reported as having been paid to the Rector and Visitors, but may be attributed by the sponsor to the Principal Investigator
The data fields that are reported to CMS are described in the Open Payments User Guide for Industry.
- Initial reporting. Applicable Manufacturers have submitted preliminary payment data to CMS for the initial reporting period, August - December 2013. Subsequent reporting cycles will include payments made during entire calendar years.
- Physician review of payment data. Before publication, reported payments to physicians cannot be reviewed by UVA administration. Therefore, physicians are strongly urged to review their preliminary payment data. The window for review of payments during 2013 ran from July 14 to September 11, 2014. See the CMS program registration page describes the two-step process: you must first register for the CMS Enterprise Portal and then for the Open Payments system. CMS also has published an Open Payments User Guide.
- Correction of errors in the Open Payments database. During the data review period, you can dispute any of your payment data. See the CMS dispute and resolution page. The payor has an additional 15 days to correct its information in the CMS database. Note: PPACA includes penalties for companies that under report rather than over report. Payments that cannot be resolved will be marked on the CMS web site as "disputed."
- Publication of final reporting data. After the review/correction period, CMS will finalize and post the data on the Open Payments site. This will occur no later than September 30, 2014. CMS will update the current and previous year’s on-line reports at least once annually after the initial posting.
CMS has created several resources to help physicians with the review and dispute resolution process. The two-step registration process is described in a quick reference guide titled " Physician Registration." Disputes are handled within the system itself. The process for disputing and resolving payment data is described in the document " Physician and teaching hospital record review and dispute functions."
If you have been compliant with SOM policy regarding financial disclosure and vendor gifts, you are in good standing institutionally. However, since we expect the data to contain some discrepancies and the final data will become public information, you should be aware of and attend to what will become part of your digital profile/reputation, by reviewing your preliminary payment data on the Open Payments site.
External review. Expect that your published payment data will be reviewed by public interest groups and the press. What may appear to be a large payment to the uninitiated eye may reflect innocuous payments for research or other activities that directly support the University. Please refer any queries from the press concerning your reported payments to: Health System Public Relations (924-5679; after business hours, 982-1100).
School of Medicine review.
- Comparison of CMS payment data to faculty financial disclosures in the SOM on-line system, to ensure that physicians have been disclosing their external financial interests as required by SOM policy and that no additional financial interests or conflicts should be monitored. Only large discrepancies between CMS data and SOM disclosures will result in queries to individual faculty.
- Examination of broad patterns of payments to SOM physicians. If reported data suggest that our faculty have been accepting small gifts from manufacturers, which is contrary to SOM policy, the SOM might bolster its education of faculty on policies and laws in this area.
- Familiarize yourself with the payment information to be reported and the review and dispute process at https://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Dispute-and-Resolution.html.
- Register with CMS and review your payment data.
- For future reporting years, maintain records of payments and transfers of value that you have received (or will receive), for comparison with preliminary payment data.
CMS has developed a free mobile app ( iOS version, Android version) to help physicians track, store, and view payments and other transfers of value from Applicable Manufacturers. It cannot be used to review or dispute your payments in the CMS database. See, also, FAQs for the mobile app. The app was updated in June 2014 to add sorting/filtering capability, enhanced tablet layout, drill-down functionality within charts, and QR code scanning. If you had downloaded the app previously, you should update it at Google Play or Apple app store.
- “Physicians” – include doctors of medicine, osteopathy, dentistry, dental surgery, podiatry, optometry, and chiropractic medicine. As defined by the law, “physician” includes his/her immediate family members.
- “Covered Products” – drugs, biologicals, devices, and medical supplies reimbursed by Medicare, Medicaid, or Children's Health Insurance Program. Covered drugs and biologicals require a prescription or doctor's authorization to administer. Covered devices and medical supplies require pre-market approval or pre-market notification by the FDA
- “Applicable Manufacturers” must be physically located or conduct activities within the US:
- Type 1 Manufacturers engage in the production, preparation, propagation, compounding, or conversion of a Covered drug, device, biological, or medical supply. Includes distributors or wholesalers that hold title to a covered drug, device, biological or medical supply;
- Type 2 Manufacturers are under common ownership with and provide support the listed activities of a Type 1 Applicable Manufacturer.
- Open Payments program site and source for most of this document: http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-payment-Transparency-Program/index.html
- Open Payments fact sheet for physicians: http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Downloads/Physician-fact-sheet.pdf.
- Brochure explaining the Open Payments program, for sharing with patients.
- Open Payments FAQs (note subtopics on the left): https://questions.cms.gov/faq.php?id=5005&rtopic=2017.
- AMA toolkit for physicians: http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports.page