On May 6, New Jersey made immediate changes to the prescriber “gift ban” (also known as “Limitations on and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescriber”).[i] While regulatory changes can be difficult to understand, let alone implement, the recent changes are arguably better for meeting planners. In fact, the changes mostly serve to provide clarity and relax the rules.
If you are already well versed on the original rule, keep reading below for a short summary of the changes. If you would like to learn more about the entire rule, including the changes, you can click here for the text of the rule, or here for an analysis. There are five key changes to the rule.
First, the Purpose section of the rules has been expanded to include both a purpose and scope. While the purpose remains the same, the rule now includes a scope. It now clearly states that the rule applies to a prescriber with an active New Jersey license who either (1) practices in New Jersey; or (2) has New Jersey patients regardless of the prescriber’s practice site. [ii]
Second, the Definitions section was amended in four areas. A “Consumer Price Index” definition was added for the purposes of the meal cap and may be reviewed by the state for possible annual adjustment.[iii] Next, the definition of an “educational event” was changed to specifically include events where “information about disease states and treatment approaches” are presented.[iv] This was not explicitly stated in the prior version. It also clarifies that its definition might not align with the FDA’s classification of promotional or educational events for the purposes of this rule.[v] “Modest meals” have been redefined from $15 per meal to “a ‘fair market value' of $15 for breakfast or lunch and $30 for dinner.”[vi] This threshold may be adjusted annually if the Consumer Price Index warrants. Lastly, “fair market value” for “modest meals” has been clarified to exclude costs of delivery, service, facility rental fees, and tax.[vii]
Third, the rule now explains that non-promotional event meals—even if supported by a manufacturer to facilitate an educational program and maximize prescriber learning, including information about disease states and treatment approaches—are excluded from the modest meal limitations in this rule and are not calculated in the bona fide services cap.[viii] However, there still might be room for interpretation when speaker programs are at issue. Some speaker programs include a mix of disease state awareness and product promotion. The question will be whether the event is “primarily dedicated in both time and effort to promoting objective scientific and educational activities and discourse” and to “further attendees’ knowledge on the topics presented.”[ix] Pharmaceutical manufacturers define and structure their speaker programs differently and so the label of “speaker program” is not enough to determine if a meeting is a “promotional event” or “non-promotional event” according to this rule. The classification of an event as “non-promotional” must be based on the content contained in the individual presentation, which is something that each pharmaceutical company must consider to remain compliant.
Fourth, meals provided by a manufacturer for promotional activities are still subject to the “modest meal” limitations but are not subject to the bona fide services cap.[x]
Finally, while the $10,000 annual cap on HCP remuneration already excluded payments for speaking at educational events, the clarification of what programs are included in the category of “educational events” may now provide HCPs greater opportunity to participate in educational programming.[xi]
With these changes, meeting planners will likely see renewed guidance from their clients or compliance leaders, and managing meetings with New Jersey prescribers should become a little less complex.
Laura Konwinski is the senior director of global compliance with BCD Meetings & Events.
This article is for educational purposes only as well as to provide general information. The article should not be used as a substitute for competent legal advice from an attorney in your state or jurisdiction. The materials presented in this article may not reflect the most current legal developments. BCD Meetings & Events LLC is not responsible for any errors or omissions in the content or for any damages arising from reliance on information contained in the article.
© 2018 Laura Konwinski, all rights reserved
[i] N.J.A.C. 13:45J
[ii] N.J.A.C. 13:45J-1.1
[iii] N.J.A.C. 13:45J-1.2
[iv] N.J.A.C. 13:45J-1.2
[v] N.J.A.C. 13:45J-1.2
[vi] N.J.A.C. 13:45J-1.2
[vii] N.J.A.C. 13:45J-1.2
[ix] N.J.A.C. 13:45J-1.2
[x] N.J.A.C. 13:45J-1.4
[xi] N.J.A.C. 13:45J-1.2