CMS Frequently Asked Questions

From CMS.gov; for more information visit the Center for Medicare and Medicaid Services’ Open Payments page  

What items or materials are considered education materials and are not reportable transfers of value?

Education materials and items that directly benefit patients or are intended to be used by or with patients are not reportable transfers of value. Additionally, the value of an applicable manufacturer’s services to educate patients regarding a covered drug, device, biological, or medical supply are not reportable transfers of value.  For example, overhead expense, such as printing and time development of educational materials, which directly benefit patients or are intended for patient use are not reportable transfers of value.  (FAQ8161)

Are payments provided to physicians for speaking at a continuing medical education event reportable?

Speaker compensation at continuing education event such as Continuing Medical Education (CME) conference is not required to be reported by an applicable manufacturer if all of the following criteria are met: (1) the CME program meets the accreditation or certification requirements and standards of the Accreditation Council for Continuing Medical Education, the American Academy of Family Physicians, the American Dental Association’s Continuing Education Recognition Program, the American Medical Association, or the American Osteopathic Association, (2) the applicable manufacturer does not select or suggest the covered recipient speaker nor does it provide the third party vendor with distinct, identifiable individuals to be considered as speakers for the accredited or certified continuing education programs; AND (3) the applicable manufacturer does not directly pay the covered recipient speaker.  (FAQ8165)

Are items or materials used to educate physicians, which may indirectly benefit patients, included in the education materials exclusion?

No, the education material exclusion is limited to materials and items directly benefiting patients or intended for patient use as required by the Affordable Care Act Section 6002. Education materials, such as medical textbooks or journal reprints, that are educational to covered recipients but are not intended for patient use or directly beneficial to patients are not included in the exclusion.  (FAQ8171)

If an applicable manufacturer supports an unaccredited educational program at a large annual conference and serves buffet meals, but also provides payment for general sponsorship or has an exhibit booth, will the awareness standards be applicable to the buffet meals provided at the unaccredited program?

The question of whether an applicable manufacturer must report a buffet meal provided to physician attendees at an unaccredited educational program taking place at a large annual conference requires a fact-specific inquiry as to whether it is difficult for the manufacturer “to definitively establish the identities of the physicians, who partake in the food or beverage.” (78 Fed. Reg. 9479) The preamble explains that the exception in 42 CFR 403.904(h)(2) only applies to situations where an applicable manufacturer provides a large buffet meal, snacks or coffee that are made available to all conference attendees and where it would be difficult to establish the identity of the physicians, who partook in the meal or snack. This exception does not apply to meals provided to select attendees at a conference where the sponsoring applicable manufacturer can establish the identity of the attendees. 
(FAQ8390)

To determine if an applicable manufacture (or applicable group purchasing organization) has met the $100 aggregate threshold for reporting small payments to a covered recipient or physician owner/investor, is it required to aggregate small payments or other transfers of value different across different nature of payment categories?

Yes. To determine if payments or other transfers of value exceed the $100 threshold and must be reported, applicable manufacturers and applicable group purchasing organizations must aggregate payments of less than $10 across multiple nature of payment categories. For example, if the applicable manufacturer provides a physician with multiple separate payments valued under $10 each and the cumulative amount of those separate payments exceeds $100 during the year (e.g. 6 hot dogs - $9 per hot dog, 3 sporting tickets - $9 per ticket, and 3 cab fares - $9 per cab), the threshold will have been met and these payments must be reported. 
(FAQ8364)