On July 3, 2014, the Centers for Medicare and Medicaid Services (CMS) published proposed amendments to its rules implementing the Sunshine Act. Among other things, the proposed amendments would remove section 403.904(g)(1), which currently excludes the reporting of payments associated with certain continuing education events. This section currently states that applicable manufacturers are not required to report payments or other transfers of value provided as compensation for speaking at a continuing education program, so long as the following conditions are met:
- The event at which the covered recipient is speaking meets the accreditation or certification requirements and standards for continuing education for the Accreditation Council for Continuing Medical Education (ACCME), the American Academy of Family Physicians (AAFP), the American Dental Association’s Continuing Education Recognition Program (ADA CERP), the American Medical Association (AMA), or the American Osteopathic Association (AOA);
- The applicable manufacturer does not pay the covered recipient speaker directly; and
- The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program.
According to CMS, since publishing the final rules, other non-named accrediting organizations have requested that payments made to speakers at their events also be exempted from reporting. To this point, CMS notes that its "apparent endorsement or support to organizations sponsoring continuing education events was an unintended consequence of the final rule." Additionally, CMS notes that many stakeholders were concerned that the reporting requirements are inconsistent, as they require the reporting of certain continuing education payments and not others.
In light of this feedback, CMS has proposed to remove section 403.904 (g) in its entirety, noting that it is redundant with the "indirect payments" exclusion set forth in section 403.904 (i)(1). Section 403.904 (i)(1) specifically excludes from the reporting requirements indirect payments or other transfers of value where the reporting entity is unaware of and does not know the identity of the covered recipient during the reporting year or by the end of the second quarter of the proceeding reporting year. In these instances, the reporting entity provides funding and gives "full discretion" to the continuing education provider. On the other hand, CMS has identified instances where the reporting entity conditions the provision of financial sponsorship for a continuing education event based on the inclusion of particular covered recipients, or pays a covered recipient directly for speaker services at a continuing education event. CMS believes that these instances should be reported, and is seeking comments on two alternative approaches:
- CMS would expand the list of accreditation organizations by name; or
- CMS would expand the list of accreditation organizations by articulating accreditation or certification standards that would allow a CME program to qualify for the exclusion.
In addition to comments regarding these two alternative approaches, CMS is also requesting suggestions about what standards, if any, it should incorporate.
CMS has also proposed to amend §403.904(c)(8), which currently requires applicable manufacturers of drugs or biologics to report the marketed name for each drug or biological related to a payment or other transfer of value. As for applicable manufacturers of devices or medical supplies, CMS currently requires these entitles to report either the marketed name, product category, or therapeutic area. In an effort to make the reporting requirements uniform for all applicable manufacturers, CMS has proposed that all manufacturers report the marketed name of all covered and non-covered drugs, devices, biologicals, or medical supplies, "unless the payment or other transfer of value is not related to a particular covered or non-covered drug, device, biological or medical supply."
Further, CMS has proposed to amend §403.904(d), which requires applicable manufacturers to report stock, stock options, or any other ownership interest. Specifically, CMS has proposed to require the reporting of stock, stock option or any other options as distinct categories, which would enable CMS to "collect more specific data regarding the forms or payment made by applicable manufacturers." CMS is seeking comments on "the extent to which users of this data set find this disaggregation to be useful, and whether this change presents operational or other issues on the part of applicable manufacturers."
CMS is accepting comments regarding these proposed amendments until 5 p.m. on September 2, 2014. Please click here for instructions on submitting comments.