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PhRMA Code Revised After OIG Expresses Skepticism About Industry Speaker Programs

Publisher: Day Pitney Cybersecurity, Healthcare and Technology (C.H.A.T.) Newsletter
September 16, 2021
Day Pitney Author(s) Erin Magennis Healy

The Pharmaceutical Research and Manufacturers of America (PhRMA) has revised its Code on Interactions with Health Care Professionals, commonly referred to as the PhRMA Code, in an apparent response to the November 16, 2020 Special Fraud Alert issued by the U.S. Department of Health & Human Services, Office of Inspector General (OIG), which expressed skepticism about the validity of industry-sponsored speaker programs.

The PhRMA Code has always reflected the fundamental principle that company-sponsored speaker programs should be designed to deliver relevant substantive educational information. Building on this principle, the revised PhRMA Code now emphasizes that invitations to such programs should be limited to those attendees with a bona fide educational need to know the information presented. The updated PhRMA Code emphasizes that repeat attendance at a speaker program on the same or substantially the same topic where a meal is provided is only appropriate if the attendee has a bona fide educational need to receive the information presented. It also confirms that attendance by speakers as participants in programs after speaking on substantially the same topic is generally not appropriate. As revised, the PhRMA Code still permits modest meals incidental to speaker programs but reiterates that high-end restaurants and other such venues are not appropriate, and it now prohibits serving or providing alcohol in connection with such programs.

Although the PhRMA Code is a voluntary code of ethics, the OIG has previously indicated that arrangements failing to meet the minimum standards set forth in the PhRMA Code will likely receive increased scrutiny from government authorities. The boundaries surrounding a compliant speaker program have been narrowed by the Special Fraud Alert and the revisions to the PhRMA Code. Companies planning to continue offering in-person speaker programs to healthcare providers should evaluate whether existing policies and practices align with the new guidance.

The updated PhRMA Code, which takes effect on January 1, 2022, can be accessed here.

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