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Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

Aug. 18, 2014 – The Centers for Medicare & Medicaid Services (CMS) recently announced that it had reopened its Open ... read more

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ISMPP Offers Guidance on Value of Publication Support in Sunshine Act “Suggestions Document”

Aug. 19, 2013 – Companies struggling to define and place a value on the publication support they provide to physicians authoring medical publication submissions under the Sunshine Act will find some reasonable advice in a “suggestions document” recently published by the International Society for Medical Publication Professionals (ISMPP).

“Our action here was to understand and interpret this provision of the final rule and respond to questions from our members about it,” said Bob Norris, ISMPP founding member and past president, and founder of CHC Group, who served on the ISMPP Task Force that authored the document. “There is so little direct guidance from the Centers for Medicare & Medicaid Services (CMS) on how to define transfers of value for this practice, so we wanted to step in to fill that gap,” he said.

The ISMPP Task Force document – which is designed to help entities determine the value of publication support that is transferred and how to apportion that value among covered recipients (CRs) – is based on a review of the Physician Payment Transparency Program final rule, internal discussions, and meetings with CMS representatives and stakeholders in the medical publications space.

Norris told the Coalition for Healthcare Communication that informal meetings with CMS were “very constructive in determining the parameters” of the guidance, but that CMS’ direct responses to questions on this issue sent to the agency through its Web site “will be the ultimate answer.”

Parsing the final rule’s mandate that transfers of value (TOV) made by applicable manufacturers (AMs) to CRs be reported under the Sunshine Act, the ISMPP Task Force considers the TOV to be “any support provided to CR authors for publication that will be submitted, or is intended to be submitted, to a scientific or medical journal, or provided to authors/speakers for submission to or presentation at a professional congress.”

What to Report

According to the Task Force, AMs should consider the following activities when determining what comprises publication support:  

  • Medical writing and editing under the direction of the author(s)
  • Statistical support performed specifically for the publication
  • Literature searches and provision of references
  • Graphic support
  • Securing permissions/permission fees
  • Journal submission
  • Submission and publication fees (includes fees associated with open-access journals)
  • Direct costs for travel, meals, and other expenses associated with performance of work associated with publications (e.g., congress attendance; publication steering committee).

ISMPP also suggests that publication support activities “are reportable regardless of whether they are included in or outside of a research contract,” although they may be reported using different templates (General Payments, Physician Ownership or Research Payments).

Allocating and Assigning Value

For many manufacturers, the trickiest reporting element is how to place a value on the publication support they provide and allocate it among authors. Norris noted that this was the “diciest question” the ISMPP Task Force had to tackle, and that although the group “tried to come up with a definitive ‘this is how you do it’ approach,” it saw the need for several options.

The ISMPP Task Force states in the document that manufacturers should “individually determine the method for allocating specific TOV to each CR who was provided publication support.” The defining question here, according to the ISMPP, is: “What is the value of specific tasks that the authors would have had to perform or secure for themselves if the AM had not provided publication support?”

To help answer that question, the Task Force provides sorted lists of publication support activities that fall into two categories: (1) “Work That an Author Would Most Likely Do” (which should be included in the value calculation); and (2) “Work That an Author Would Most Likely Not Do” (which should not be included in the value assessment).

When assigning the calculated value of the support to authors, the ISMPP Task Force suggests two approaches for consideration and comments both that companies also may have other interpretations and that individuals should “seek internal legal and policy guidance on interpretation and application of the law to their company.”

The first approach, a “project-by-project determination,” takes the total cost of the publication support and divides it by the number of authors associated with the publication. The document includes an example of this scenario:

“A primary manuscript costs $30,000. There are a total of 6 authors; 3 authors are US CRs, 2 authors reside and practice outside of the US and do not hold current US licenses, and 1 is an AM employee. For the purpose of this example, it is determined that 30% ($9,000) of the total cost is for non-content-development activities. The total value of the content-development activities is $21,000; the reportable TOV per author for the development of the manuscript is $3,500 ($21,000/6) TOVs are reported for the 3 US authors (3 x $3,500).”

A second assignment approach described in the ISMPP document uses “average fair market value” (FMV) as the sum of average costs associated with the specific type of publication, with the same FMV amount to be reported per author. So, if the average cost of a manuscript for Company X is determined to be $28,000 with an average of 6 authors, the document states, after you have subtracted the average non-content-development related costs of 27%, the content-related costs of the work are $20,440 and the reportable per-author FMV is $3,406 per manuscript ($20,440/6).

Whichever approach is used, the Task Force underscores the importance of submitting an assumptions document to CMS describing the methodology used to determine reportable costs. “The assumptions document is an integral part of the report, especially due to the lack of CMS guidance,” Norris said, “as long as you are transparent and list how you allocate value.” He also noted that although there may be some justifiable outliers, “Using the same methodology across the board is more defendable.”

Norris added that he hopes there will not be “unintended consequences” to the mandated reporting of publication support. “Although this support has value, doctors are not receiving a penny; the support only helps get important data published quickly so it can change clinical practice as appropriate,” he said. “If doctors back off from receiving this support because they don’t want that TOV listed next to their names, the process of getting those data out without assistance will take much longer, and that will affect patients.”

Reporting under the Sunshine Act began on Aug. 1.