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 will be reported to CMS?
Schedule for reporting, review, and posting of data
How published payment data will be used
How you can prepare
The Open Payments mobile app
Definitions from the sunshine provisions
Links to additional information
"Payments” include both cash transactions and transfers of value (such as meals or sponsored travel) $10. Manufacturers also must report aggregate payments to a single payee over $100 in a calendar year. Payments will be 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 payment you direct that your compensation 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 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 specific data fields that will be reported to CMS are described in the Open Payments User Guide for Industry.
- Initial reporting. For the initial reporting period, August through December 2013, Applicable Manufacturers must submit preliminary payment data to CMS no later than March 31, 2014. Subsequent reporting cycles will include payments made during entire calendar years.
- Physician review of payment data. Physicians are strongly urged to review their preliminary payment data when they become available in 2014. CMS has announced that they will soon provide more specific information concerning the period for physician registration and review/correction of payment data. The latter will begin no later than August 1, 2014. We recommend that faculty physicians register for e-mail updates on the Open Payments site, in order to receive notification that preliminary data are available for review. Physicians also can contact the companies that have paid them during the reporting period, to determine what the companies intend to report. Physicians will have 45 days to review and dispute their preliminary data with the payor (see “Reviewing your payment data” below).
- Correction of errors. Payors have an additional 15 days to correct their information in the CMS database. If you dispute any of your payment data, you might experience some push back from a payor because PPACA is written to penalize companies for under reporting rather than over reporting. Payments that cannot be resolved will be marked on the CMS web site as "disputed."
- Publication of final reporting data. After that 60-day 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.
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, individual physicians should be aware of and attend to what will become part of their digital profile/reputation, by asking vendors what payments they will report, or by reviewing their preliminary payment data on the CMS site (see "Reviewing your payment data" below).
External review. The School of Medicine anticipates that 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 directly in support of 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. The SOM will focus on the following:
- Comparison of CMS payment data to faculty financial disclosures in the SOM on-line system, to ensure that our 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 when large discrepancies between CMS data and SOM disclosures are noted will faculty be contacted for an explanation.
- Examination of broad patterns of payments to SOM physicians: for example, indications that faculty have been accepting small gifts from manufacturers (other than allowable educational materials or drug samples for patient use), which is contrary to SOM policy. This information will help the SOM assess its current education of faculty on existing policies and laws in this area.
- Familiarize yourself with the payment information to be reported (see "What information will be reported to CMS?");
- Register with CMS early in 2014. You can subscribe to updates on the process on the Open Payments site, at "Email updates" below "About this site."
- Review your preliminary payment data in the CMS database (see "Reviewing your payment data" below).
- Going forward: maintain records of payments and transfers of value that you have received, for comparison with preliminary payment data.
CMS has developed a free mobile app to help physicians track, store, and view payments and other transfers of value from Applicable Manufacturers. It cannot be used to review your payments as reported in the CMS database or to dispute individual payment reports. The app runs on iOS and Android platforms.
iOS: https://itunes.apple.com/us/app/open-payments-mobile-for-physicians/id667567467?mt=8. Requires iOS 6.0 or later. Compatible with iPhone/iPad/iPod Touch; optimized for iPhone 5.
Android: https://play.google.com/store/apps/details?id=com.cms.physician. Requires Android 2.3.3 or higher.
- Brochure explaining the Open Payments program, for sharing with patients.
- Two CME activities that explain the program and opportunities for physicians to review their data.
- “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.
- 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