On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released its long-awaited final rule implementing the Sunshine provisions of the Patient Protections and Affordable Care Act (PPACA). The National Physician Payment Transparency Program, also known as the Sunshine rule, requires manufacturers of drug, device, biological and medical supplies to collect data on gifts and payments to teaching hospitals and physicians starting on August 1, 2013, and report it to CMS by March 31, 2014, and on June 30 each year thereafter. Manufacturers must also report certain ownership or investment interests by physician or their immediate family members held any point during the reporting year. CMS will publish the transparency information submitted by industry on its public website, Open Payments at www.cms.gov.
We encourage you to become familiar with the Sunshine rules and its impact on you, your practice, and your patients. To assist in this endeavor, we highlight important aspects of the transparency program below.
1 If a manufacturer that compensates a physician for providing a consulting or other service before the data collection requirements become effective, but does not actual make payment or a transfer of value to the physician until after the start of the data collection requirements, such payment would be reportable because the payment was made to the physician after the start of the data collection requirement.
2 Prior to posting the payment information on CMS Open Payment website, a 45-day review and correction period for accuracy by physicians, followed by a 15 day resolution period by manufacturers, should occur.
Direct payments or other transfers of value are those payments or transfers of value made by a manufacturer directly to a physician. Indirect payments or other transfers of value refer to payments or other transfers of value made by a manufacturer to physicians through a third party. In general, both direct and indirect payments or transfers of value made by manufacturers to physicians must be reported.
However, in some limited circumstances, indirect payments or transfers of value may be excluded from the reporting requirements. When a manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a physician, this type of indirect payment is reportable. However, if the indirect payment is made to a third party and the third party uses its own discretion on the distribution of the funds, this indirect payment is not reportable. For example, if a manufacturer provided an unrestricted grant to the AUA to use at its discretion, and the AUA chose to use the donation to make grants to physicians, those grants would not constitute a reportable "indirect payment" because the manufacturer did not require, instruct, or direct the organization to use the donation for grants to physicians. In this situation, the applicable manufacturer would not be required to report the donation, even if a portion of the payment or other transfer of value was ultimately provided to physicians as a grant (or some other type of payment or other transfer of value). However, if a manufacturer gave money to the AUA earmarked for the purpose of funding awards or grants for physicians, the awards or grants would constitute indirect payments to covered recipients and would be subject to the reporting requirements.
While accredited or certified CME events, including the AUA Annual Meeting, are largely exempt from the transparency program, we highlight a few key issues related to urologist engagement in CME activities and events.
Speaking at CME Events
Manufacturers are not be required to report payments to speakers at accredited CME events so long as manufacturers do not select the speakers or pay them directly. Accredited CME events are those that have been certified by the CME accreditors, including the Accreditation Council on Continuing Medical Education (ACCME), the American Osteopathic Association (AOA), the American Academy of Family Physicians (AAFP) and the American Medical Association (AMA). The AUA is accredited by ACCME to provide CME and takes responsibility for the content, quality and scientific integrity of its CME activities.
In the case of unaccredited and non-certified CME, if the payment or other transfer of value is made indirectly, it will be subject to the same reporting requirements for all other indirect payments. Direct payments or transfers of value, regardless of whether the CME event is accredited or unaccredited, must be reported. Information about direct and indirect payments was previously discussed.
Meals and Snacks at CME Events
For meals in a group setting (other than conferences or other similar large-scale settings), CMS may require applicable manufacturers to report the per person cost of the food or beverage for physicians that partake in the meals. If the per person cost exceeds the minimum threshold amount of $10, the manufacturer must report the food or beverage as a payment or other transfer of value for each physician who participated in the meal.
Food and beverage provided at conferences in settings where it would be difficult to establish the identities of the physicians partaking in the meal do not need to be reported. Examples of this might be coffee and other beverages served in the “exhibit hall” to all attendees of the AUA Annual Meeting. However, CMS does not intend this to apply to meals provided to select individual attendees at a conference where the sponsoring manufacturer can establish identity of the attendees. Examples of this might be an industry-sponsored dinner where individual physicians are invited to participate in the event and the manufacturer is able to establish the identities of people partaking in the meal.
Physicians who do not want to receive meals should make clear to manufacturers that they do not accept them.
Incidental Items Received during CME Events
Small payments or other transfers of value (less than $10) do not need to be reported, except when the total annual value of payments or other transfers of value exceeds $100. For example, small incidental items (such as pens and note pads) that are provided at the AUA Annual Meeting and similar large-scale events are exempt from the reporting requirements, including the need to track them for aggregation purposes. However, if a manufacturer hands out an item above the $10 threshold during the AUA Annual Conference, they must track and report who received the item since it is a more significant transfer. The AUA is working with exhibitors at the AUA Annual Meeting and other AUA events to ensure physicians are notified in advance that acceptance of items above the threshold would be subject to reporting.
In the case of unaccredited and non-certified CME, if the payment or other transfer of value is made indirectly, it will be subject to the same reporting requirements for all other indirect payments. Direct payments or transfers of value, regardless of whether the CME event is accredited or unaccredited, must be reported.
While not mandatory, CMS has encouraged manufacturers to allow physicians to review information about payments and transfers of value prior to submitting it to the agency for public reporting. The AUA, along with the rest of the medical community, have encouraged industry trade associations to collaborate with its manufacturers on the development of a mechanism that would allow physicians to review payments and transfers of value from multiple manufacturers. In the meantime, physicians should be diligent in keeping track of potentially reportable payments and transfers of value. In addition, prior to accepting payments or transfers of value, physicians should seek clarification from industry representatives about whether those items or transfers of value will be reported.
Because physicians will be identified by their national provider identifier (NPI), it is important that you review your NPI profile to ensure it is current and accurately reflects your current specialties. If it does not, there is the potential that a reported interaction could be perceived as unethical or in violation of applicable U.S. Food and Drug Administration (FDA) regulations. Additional steps you can take include:
CMS finalized a 45-day "review and correction" period that will allow physicians to review and dispute information about payments and transfers of value reported by manufacturers before it is made public. Manufacturers will have an additional 15 days to correct data for purposes of resolving disputes. Urologists are encouraged to review reported information and submit corrections as early in the 45-day window as possible. As explained in the final rule, payments or other transfers of value that cannot be resolved by the end of the 15-day resolution period will be marked as "disputed," but the manufacturer's most recent attested data subject to the dispute will be published. In order to review the payments, physicians must register with the Open Payments system at any time beginning in early 2014. After the initial posting of information, CMS will update the payment information annually. The payment information will be made public on September 30, 2014.
We anticipate significant growing pains as industry attempts to comply with the new reporting requirements. The AUA, along with the rest of the medical community, will continue to seek clarification from CMS on issues where questions remain and collaborate with industry on solutions that will enable physicians to keep accurate records of payments and transfers of value before the information is made public. As new details emerge, the AUA will notify you.
Additional information and resources for AUA members on the Sunshine provisions, including – available on the AUA website or on CMS’ website.
© 2016 American Urological Association Education and Research Inc. All Rights Reserved.