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Reaction to Proposed Changes in PPSA

July 24, 2014

Feedback and Input Shed Light on Sunshine

Today we’re going to be talking about reactions to proposed changes in the PPSA, or Physician Payment Sunshine Act. As you may recall, the Federal Centers for Medicare and Medicaid Services (CMS) issued a final PPSA rule in 2013 that distinguished between direct payments from pharmaceutical and other industry companies to physicians, and grant payments that were made through independent educational grants. For those direct payments from industry to physicians, those became reportable to a federal database under the PPSA final rule. However, there was an exemption created for grant payments to accredited medical education organizations that were used to develop CME activities. However, in July of 2014, CMS proposed changes to delete that exemption (the CME exclusion) in its entirety. The CME Coalition, a Washington DC based trade organization that Global is a member of, responded to the announcement in a press release and vowed to fight the proposed rule changes. From our analysis, there are three main reasons organizations are opposing these proposed changes from CMS.

Final rule issued in 2013

The CMS only recently implemented its final rule after much debate and analysis in 2013. All of the stakeholders that prepared to comply with that rule, and are now doing so, are now being faced with another change in the final rule. The consensus seems to be that the final rule should be given time to play out before any drastic changes are made.

Exemption for IME grants

A second reason that organizations oppose the new changes is that the standing rule provides an exemption for independent education grants for good reasons. Those independent education grants are being paid to accredited medical education organizations and those groups, not pharmaceutical companies, are making all decisions about who to hire for faculty, who to pay, and they control the grant money directly without any influence from pharmaceutical companies.

No Evidence for Change

The third reason for the opposition is that there is currently no evidence that the current final rule needs to be changed. There have been no complaints, and no evidence cited, so why propose changes to a rule that is currently working? We analyzed and surveyed several funding organizations and learned that there is a mix of feedback at this time. Some organizations believe that this reversal on the part of CMS would create confusion and put further pressure on already limited CME grant resources. However, other funding organizations do not see this as a major problem since transparency reporting already has occurred on the promotional side of industry, and no matter what the result of the interactions a final decision probably would not occur until later in 2014, with possible implementation in mid to late 2015. The CMS is accepting comments on the proposed changes up until September 2, 2014, and we encourage all stakeholders to provide comments to CMS. As we learn more about developments with the proposed CMS changes, we will be reporting on any updates and will communicate those updates as soon as they become available. As always if you have any questions about this proposed change, or any CME questions, feel free to contact us here.