Research: Guidance on the PPACA “Open Payments” Process
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 are published on the Centers for Medicare and & Medicaid Services (CMS) Open Payments web site, representing 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?
“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
- Research- 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
- 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
- Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program (if the corporate donor specifies you as a speaker at a society program)
- 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 reported to CMS are described at this site.
Schedule for manufacturer reporting, physician review, and CMS posting of data (for each calendar year)
- Initial reporting. Applicable Manufacturers submit preliminary payment data on a calendar year basis.
- 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 period for reviewing and disputing the previous year’s payment data generally runs from early April through mid-May. To review your own payment data, you must register for the CMS Enterprise Portal and then register for the Open Payments system. See the instructions for registering. If you registered previously, you may be asked to update your password.
- Correction of errors in the Open Payments database. During the data review period, physicians can dispute one or more of their reported payments. See the CMS dispute and correction page. The payor has an additional 15 days to correct its information in the CMS database, after the review period has ended.Payments that cannot be resolved will be marked on the CMS web site as “disputed.” Note: PPACA includes penalties for companies that under report rather than over report. Some companies are reporting grant/contract payments as having been made to both the Medical Center (which shares the same tax ID as the rest of UVA) and the Principal Investigator of the research project.
- Publication of final reporting data will occur by the end of June. After the review/correction period, CMS finalizes and posts the data on the Open Payments site. CMS updates the current and previous year’s on-line reports at least once annually after the initial posting.
How will your published payment data be used?
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 attend to what will become part of your digital profile/reputation by reviewing your preliminary payment data on the Open Payments site.
It is possible that your published payment data will be reviewed by public interest groups, the press, and patients. 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 missions of the University. Please refer any queries from the press concerning your reported payments to: Health System Public Relations (434.924.5679; after business hours, 434.924.0000).
The School of Medicine will perform the following reviews:
- 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. For instance, if CMS data suggest that our faculty have been accepting small gifts from manufacturers (contrary to SOM policy), we might bolster our education efforts in this area.
How to prepare for the Open Payments process
- Familiarize yourself with the program information provided at the Center for Medicaid and Medicare Services website.
- Register with CMS and review your payment data.
- Dispute any charges that are not yours. Make sure that your dispute is resolved to your liking.
- Maintain records of payments and transfers of value that you have received (or expect to receive), for comparison with preliminary payment data in the coming year.
Definitions governing Open Payments (from PPACA sunshine provisions)
- “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.
PPACA “Sunshine Provisions” and Continuing Medical Education
PPACA includes some “carve out” exemptions from reporting by Applicable Manufacturers, for CME certified activities/programs. This does not represent a blanket exemption for CME related events, as PPACA still requires reporting of some payments/transfers of value to physician participants at CME activities and to faculty/speakers at non-CME certified events.
EXEMPT CONTINUING EDUCATION ACTIVITIES
A. Payments and other transfers of value as compensation for speaking at certified continuing education activities, if all three of the following apply:
- The continuing education activity meets the accreditation or certification requirements and standards for continuing education by one of the following organizations: Accreditation Council for Continuing Medical Education (ACCME); American Academy of Family Physicians; American Dental Association’s Continuing Education Recognition Program; American Medical Association; or the American Osteopathic Association.
- The applicable manufacturer does not pay the covered recipient directly;
- The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor/provider) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program.
Note that Provisions 2 and 3 are and have historically been forbidden by the ACCME Standards of Commercial Support and the OIG Guidance to Industry on Interactions with Physicians. See ACCME Standards of Commercial Support and OIG Guidance to Industry on Interactions with Physicians.
B. Food and beverage, when the cost of the recipient’s meal in a group setting (among covered recipients, such as a buffet) is not separately identifiable.
C. For large, unaccredited educational programs where it may be difficult for the applicable manufacturer to establish the identity of specific physicians who have partaken of food and beverage (and to determine the amount of food partaken).
D. Educational materials directly benefiting patients or intended for patient use, per PPACA.
REPORTABLE CONTINUING EDUCATION RELATED ACTIVITIES
A. Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program or at a certified CE program for an organization that is not listed as exempt (see above).
B. Travel, lodging and meals, entertainment, and all other payments to physician attendees that are provided in conjunction with accredited or certified CME events (with exception of educational materials included in the tuition fees for certified CME activities that meet all three criteria above).
C. Sponsored meals, receptions or breaks where the applicable manufacturer can identify specific attendees.
D. Materials such as medical textbooks, journal reprints for the further education of covered recipients but not intended for patient use or directly beneficial to patients .
E. Awards from specialty societies provided to covered recipients (including fellows).
- Some Applicable Manufacturers are electing to report more broadly than others, so there will be variations by company with respect to the reporting requirements of PPACA.
- In an effort to track and report these data, the Office of Continuing Medical Education will soon request NPI numbers from all physician and fellow presenters and participants.
- If you need clarification on these reporting requirements or exemptions, please contact the Office of Continuing Medical Education (924-5310).