What is in this article?:
- The Implications of the Physician Payments Sunshine Act for CME Providers
- Open Payments and CME
- How CME Providers and Stakeholders Can Comply with Open Payments
- Additional Areas of Importance for CME Providers and Stakeholders
- Any Questions?
During the past 50 years, we have seen an unprecedented extension in life expectancy, from age 68 in 1950 to age 78 today. Many of our health improvements are due to new therapies and treatments created by collaborations between physicians and industry.
Along with these breakthroughs come enduring concerns that physician-industry collaboration can raise ethical issues, such as potential conflicts of interest. To allay these concerns, Congress passed the Physician Payments Sunshine Act, section 6002 of the Affordable Care Act, in 2009.
How CME Providers and Stakeholders Can Comply with Open Payments
—Foremost, physicians who are currently serving, have recently served, or will serve in the future as a CME speaker or faculty should ensure that the following information is correctly listed on the National Plan and Provider Enumeration System, which CMS is requiring applicable manufacturers to use when reporting payments:
1. full name, including middle initial
2. mailing address
3. primary practice address, as well as any other addresses that might be secondary (e.g., a second practice location)
4. national provider identifier (NPI) number
5. specialty and, if applicable, sub-specialty
In addition, physicians should contact the CME provider about speaking or faculty engagements that take place after August 1, 2013, and may involve commercial support to determine whether their service is reportable.
Even after a CME provider and manufacturer have determined that a CME program is Sunshine-exempt, they still may need to evaluate whether any other payments to a speaker or faculty member serving the program may be reportable. As long as the payment or transfer of value given to a speaker or faculty at a Sunshine-exempt CME program is for the purposes of the program, such as commensurate and reasonable travel, lodging, and meals, there is likely no requirement for the manufacturer to report such payments or for a CME provider to track such payments on behalf of a manufacturer. CMS recently clarified on its FAQ Web site that “lodging, travel, and meals for speakers of an accredited or certified CME event meeting all three requirements in 42 CFR 403.904(g)(1) will be deemed to be included in the total speaker compensation and, therefore, exempt from reporting under Open Payments.”
However, CME providers and manufacturers must be aware of the added complexity of large conferences or annual meetings where multiple accredited or certified programs take place. In other words, while a faculty or speaker’s payments for the program on which they serve are exempt, their attendance or participation in other “non-Sunshine exempt” CME programs may be reportable, which is consistent with theSCS requirements.
Learners—There are certain issues with reporting meals to physician-attendees at Sunshine-exempt CME programs. CMS recently clarified in its FAQs that “meals … provided in conjunction with the accredited or certified CME event … will need to be reported for physician attendees (who are not speakers) … under the appropriate nature of payment category” of food and beverage. However, CMS clarified that in the context of Sunshine-exempt CME, if meals are provided to physicians “in a group setting where the cost of each individual covered recipient’s meal is not separately identifiable,” such as a buffet or boxed lunch, such meals would be excluded from reporting. This clarification leaves CME providers providing Sunshine-exempt CME programs with two options.
1. CME providers and meeting planners can choose to provide meals that are valued at less than $10 per person. The CME provider or meeting planner may still be required (at the direction of the manufacturer) to record which physicians partook in the meal because of the annual $100 aggregate reporting requirement. Thus, this option may still create burdens for all parties.
2. CME providers can provide meals in a buffet or boxed lunch where meals are made generally available to all participants and partakers are not separately identifiable. In such “group settings,” it is too difficult to identify which physicians partook in the meal, and if they partook, what value to attribute to them. Since the meal is provided in a group setting where it is difficult to identify the physicians that actually partook in the meal, tracking such payments or transfers of value is also not required.
Meals to physician-attendees at Sunshine-exempt CME programs that are separately identifiable (e.g., plated meals) and valued at more than $10 are reportable (those under $10 must be tracked for the $100 aggregate purpose). However, this is problematic because attributing any value to a physician-attendee for a meal at a Sunshine-exempt CME program would create an appearance that the manufacturer paid the physician to attend the program. Such an appearance would violate the ACCME SCS (no direct attendee payments by a commercial supporter for any purpose) and potentially jeopardize not only the integrity of the CME program doctors receive CME credit for, but also the CME provider’s accreditation status.
For activities that include exhibit booths, manufacturers do not have to track items with a value of less than $10, including food, that are given out at those exhibits.
As a reminder to CME providers, ACCME SCS 3.12 prohibits using commercial support to subsidize attendee travel or lodging or any other compensation for physician-attendees. Thus, there should be no other reportable or traceable payments associated with physician-attendees. Nevertheless, if a Sunshine-exempt CME program is held in conjunction with a reportable event—for example, a promotional meeting in compliance with ACCME SCS 4—manufacturers will still have to report payments or transfers of value associated with the separate reportable event as required (e.g., meals, journal reprints, and the like).
Another area of clarification, not as controversial but still important, is the educational value of materials associated with Sunshine-exempt CME programs. The final rule stated that manufacturers are “not responsible for reporting payments made to CME vendors that are used to subsidize attendees’ tuition fees for continuing education events.” Sunshine-exempt CME programs often include in their subsidized tuition slide-decks, portions of journal articles, tables or figures, and other relevant materials necessary for educating and training physicians.
Relying primarily on comments submitted by the CME Coalition, CMS clarified in its FAQs that “educational materials that are included in the tuition fees for an accredited or certified CME program that meets all three exemption conditions, such as handouts, Web downloads, or printed slides, are excluded from reporting under Open Payments provided that the content (1) does not contain any CME sponsor information, (2) the content is related to the CME program, (3) the value is de minimis, and (4) the funds used for the materials came from the same CME program grant.” As a reminder to CME providers, such materials must also be in compliance with ACCME SCS, Standard 4.