As the New Year 2022 begins, a lot of compliance professionals might also be making new year resolutions about being more diligent with their monitoring.
Here’s a quick recap of the PhRMA Code that recently got updated in the wake of OIG’s Special Fraud Alert for Speaker Programs.
The Seven Principles of Speaker Programs
The section 7 of the PhRMA Code outlines seven principles (how befitting, right?) subject to which attendees of a speaker program may be offered incidental meals of modest value.
These “seven” of the “section 7” are:
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The program must have a substantive educational purpose designed to address attendees’ bona fide educational needs.
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Only the attendees with bona fide educational needs, attend the event.
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Incidental meals must be of modest value and not the core focus of the event.
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No alcohol is paid for or provided at the event.
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The venue must be conducive to learning.
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No repeat attendees unless an attendee has bona fide need to receive the information presented.
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Neither the speakers nor other attendees bring over a guest who doesn’t demonstrate a bona fide need of the educational content that is presented.
Meals other than those in Speaker Programs
The PhRMA Code also updated its section 2 to provide guidance on meals other than those served in speaker programs. The updated language says:
“Incidental meals can be provided only where there is a reasonable expectation, and reasonable steps are taken to confirm, that each attendee has a substantive interaction or discussion with the company representative. Offering ‘grab-and-go’ meals is not appropriate.”
This essentially translates to no more lunches/dinners without company reps presenting substantive information to the HCPs.
Word for the Venues
The PhRMA Code’s section 6 has also been updated to include the following guidance about the venues for the presentation of educational content:
“high-end restaurants and entertainment, sporting, or other recreational venues or events are not appropriate.”
The Virtual World
The revised Code adds the language below to Sections Four and Five, clarifying the applicability of those sections to virtual events [which was much needed now that we live in a Zoom world, post-COVID pandemic].
“Section 4 applies to in-person CME events and virtual CME events conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.”
“Section 5 applies to in-person third-party scientific and educational conferences or professional meetings and virtual meetings conducted via a digital platform (with audio and/or video conferencing capabilities) with or without an associated in-person event.”
States that mandate PhRMA Code Compliance
Compliance with the PhRMA Code is generally optional but very helpful to avoid scrutiny by government enforcement authorities
But if you are in either of the following states, PhRMA Code compliance is mandatory along with other laws in:
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California
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Connecticut
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the District of Columbia (which requires licensed representatives to comply with the PhRMA Code)
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Massachusetts (which has a state-authored code that is based on the PhRMA Code)
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Nevada
We hope you find this quick recap of PhRMA Code updates helpful for your monitoring activities in 2022. For more detailed info, replug to our webinar: PhRMA code update and its implications.
