The New Jersey Division of Consumer Affairs (DCA) on May 6 adopted amendments to the State’s limitations on prescriber compensation from pharmaceutical manufacturers – N.J.A.C. 13:45J-1.1, 1.2 and 1.4.
As a result from changes of the original Rule, prescribers may now accept meals valued at $30 or less, the definition of an “educational event” was broadened and advisory board participation and consulting in connection with research are not subject to the $10,000 compensation cap.
Specifically, the Attorney General changed the definition of ‘education event’ to specify that notwithstanding the FDA’s classification of a program as promotional, programs that meet the definition of “education event” are deemed “education events” for purposes of N.J.A.C. 13:45J. The Attorney General also clarified that advisory board participation and consulting in connection with research, as defined by the rule, are not subject to the bona fide services cap. Likewise, payments for speaking at education events are also not subject to the cap, but “must be for fair market value and set forth in a written agreement.”
The “Prescriber Gift Ban Rule,” which was first adopted by the Christie Administration in January of 2018, was the state’s first attempt to prohibit gifts, payments, and spending limits between pharmaceutical manufacturers and New Jersey physicians.
The rule prohibited prescribers from accepting certain types of compensation from manufacturers but also provided exceptions to the compensation limitations for educational events and “bona fide” services provided as part of an educational event or other activity. The regulation limited prescriber compensation to $10,000 in a calendar year in aggregate for excepted activities like promotional activities, advisory boards, and consulting arrangements.
The original rule limited all meals being limited to a total value of $15 for each prescriber, and a prescriber serving as a speaker at an educational event had to disclose that they have accepted payment for bona fide services from the sponsoring pharmaceutical manufacturer. Payments for speaking at education events were not subject to this cap, but must be for fair market value and set forth in a written agreement.
In August of 2018, the Attorney General under the Murphy Administration proposed amendments to the rule that increased the modest meal limit to $30 for dinner, specified that the meal limit was exclusive of the costs of delivery, service, taxes or facility rental fees, and provided for a mechanism by which the modest meal amount is adjusted based on changes in the Consumer Price Index.
These amendments bring an end to a long rule making process that spanned two Governor’s administrations. Please click here to read the “Final Rule”.
Please let me know if you have any questions.