The International Society for Medical Publication Professionals (ISMPP) established the Sunshine Task Force to provide information to their members about the Physician Payments Sunshine Act's reporting requirements for medical publications. We took issue with their interpretation of the Sunshine Act a few months ago. ISMPP has now revised their policy on publications.
The Task Force's initial "Suggestions Document" recommended that Applicable Manufacturers (AMs) attribute what we believed to be excessive and unfair "transfers of value" (TOV) to clinicians and researchers working on medical publications. The suggestions came after the Task Force's brief meeting with CMS where they were left "with the impression that publication assistance of any type provided by Applicable Manufacturers (pharmaceutical, biotech, and medical device companies) to Covered Recipients (physicians and teaching hospitals) would be a reportable transfer of value under the law."
But who really benefits from the publications? The researchers? Maybe a bit, but to attribute the full cost of a publication to a clinician who received a fraction of that value in support is unfair and only serves to disincentive future work. The full value from research is felt by the journal, the readers, and the supporting company.
In the initial document, the Task Force admitted "in many instances, only a portion of the costs associated with the development of a publication should be regarded as a TOV to authors; some AM mandated internal/operational activities may not be of value to authors." However, their concession did not take away the fact that they were encouraging an excessively overbroad and harmful interpretation of "Indirect Payments" under the law.
The update to the Task Force document adopts a more nuanced view of transfers of value from AMs to covered recipients (CRs):
Yes, support for medical publications is a reportable transfer of value.
There is a TOV associated with support provided by an AM to authors who are CRs for work that authors would have had to perform or secure for themselves if the AM had not provided the support.
No, support for medical publications is not a reportable TOV.
The value of the support provided by AMs to CR authors is to the AMs, as it helps the AMs meet their ethical obligations to publish their data in a timely manner; there is no value to be transferred to the authors.
Support for publications may be a reportable TOV, depending on the circumstances.
The Task Force provides two examples:
Original research: The value of the support provided by AMs to CR authors is to the AMs, as it helps the AMs meet their ethical obligations to publish their data in a timely manner; there is no value to be transferred to authors.
Reviews; author-initiated requests for help: The value of the support provided by AMs to CR authors is to the CRs; the reportable TOV is for the work that the authors would have had to perform or secure for themselves if the AM had not provided the support.
This reading is more in line with the Sunshine Act itself:
42 CFR §403.904(c)(10) Payments to third parties.
(ii) If the payment or other transfer of value was provided to a third party at the request of or designated on behalf of a covered recipient, the name of the entity that received the payment or other transfer of value (if made to an entity) or indicate "individual" (if made to an individual). If a covered recipient performed a service, but neither accepted the offered payment or other transfer of value nor requested that it be made to a third party, the applicable manufacturer is not required to report the offered payment or other transfer of value unless the applicable manufacturer nonetheless provided it to a third party and designated such payment or other transfer of value as having been provided on behalf of the covered recipient.
We wrote in our last post that "impressions do not have the force of law." This remains true, but we are pleased that ISMPP revised their interpretation to include a more thoughtful approach to transfers of value surrounding medical publications.