Lists have also been developed enumerating the top manufacturers by research spending over $5 million. The top 10 are listed in Table 1.
ProPublica, a nonprofit corporation based in New York that describes itself as an independent, nonprofit newsroom that produces investigative journalism in the public interest, analyzed CMS data from the various databases to track general payments from manufacturers. Most of the recipients of the highest transfers of value were in the surgical specialities (see Figure 1).
In the Meantime
While physicians were attempting to review and dispute reports on transfers of value from industry, the ACR, along with more than 100 other associations, including the AMA, was busy commenting on the proposed changes to the 2015 Sunshine Act and highlighting the importance of retaining the CME exemption. CMS noted that “industry support for accredited or certified continuing education is a unique relationship” and that accredited or certified continuing education payments to speakers are not reportable because they are not direct payments to a covered recipient.
Distressingly, the proposed changes had called for the deletion of the CME exemption, under which accredited CME providers, such as the ACR, could pay physicians for their participation as speakers/faculty in certified CME activities without sponsoring companies having to report the transfer of value to CMS. CMS had reasoned that removing the CME exclusion would avoid the redundancy in another section of the Final Rule that excluded indirect payments or other transfers of value where the applicable manufacturer is “unaware” of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year. CMS had also named five accrediting bodies that were acceptable in meeting the CME exemption; removing the exemption would avoid any implied endorsement of specific accrediting bodies.
The ACR shared the viewpoint of most of the other medical specialty societies that the rule regarding indirect payments was ambiguous and insufficent to shield physicians from the requirement to report their involvement in CME. Moreover, the need of companies to be “unaware” of the recipients of funds for a period of 18 months was unreasonable given that CME activities are widely marketed and subject to media coverage.
A Modern Healthcare article quotes Andrew Rosenberg, senior advisor for The CME Coalition: “If it (the proposed CMS changes) is allowed to stand, this policy change will be massively disruptive to every stakeholder in the CME ecosystem—doctors, educators and commercial supporters—who have spent over a year preparing for the implementation of the current rules,” also adding that extending the disclosure to CME would “discourage physicians from learning new medical science by creating a false stigma.”