On May 6, the New Jersey Attorney General, Gurbir S. Grewal, finalized and made effective amendments to the rules governing physician interactions with pharmaceutical companies (“Limitations on and Obligations Associated with Prescriber Acceptance of Compensation from Pharmaceutical Manufacturers”). Originally proposed in August 2018, the finalized amendments reflect the 69 comments the Attorney General received and address, among other things, the scope of the rules, meal limits, the $10,000 bona fide services cap, and changes to definitions such as “education event,” “prescriber,” and “research.”
Scope of the Rules: The Attorney General clarified that the rules do not apply to manufacturers of medical devices and “clarif[ied] that the rules . . . do not apply to prescribers..interactions with pharmaceutical manufacturers to the extent that such pharmaceutical manufacturers also manufacture medical devices and that such interactions are directed solely to medical devices.” This means that rules apply only to prescribers; interactions with pharmaceutical manufacturers concerning prescription drugs or biologics.
Meal Limits: The Attorney General stated that he “believes that the cap is reasonable.” Thus, no changes were made to the proposed meal limitations that apply to promotional activities ($15.00 for breakfast and lunch; $30.00 for dinners). The meal limits do not apply to an “education event” nor the $10,000 bona fide services cap.
In each succeeding calendar year after 2018, the meal limits amounts are adjusted if the Consumer Price Index reflects a sum, which, if rounded, consistent with the regulation’s definition of Consumer Price Index,” would raise it by one dollar increments. The fair market value shall not include the cost of standard delivery, service, or facility rental fee charges, or of tax.
$10,000 Bona Fide Services Cap: The Attorney General stated that he “declines to change the bona fide services cap because he believes it is necessary to minimize the potential for conflicts of interest to ensure that patient care is guided by the unbiased, best judgment of the treating prescriber.” The Attorney General noted that “payments for research activities and payments to prescribers for speaking at education events are not subject to the bona fide services cap.”
“Education Event” Definition: The Attorney General stated that he “recognizes the educational value of learning about disease states and treatment options, including when there are limited options, and believes that the amendments . . . will enhance the rules to further the educational exchange between practitioners and pharmaceutical manufacturers for the benefit of patient care.” Thus, the definition of “education event” was changed to (1) clarify that it now includes information about disease states and treatment options and (2) specify that notwithstanding the FDA’s classification of a program as promotional, programs that meet New Jersey’s definition of education event are deemed education events.
“Prescriber” Definition: The Attorney General stated that he “believes that the rules should apply equally to all prescribers licensed by the State and that no distinction should be made for where the prescribers regularly practice.” The definition, as adopted, “means a physician, podiatrist, physician assistant, advanced practice nurse, dentist, or optometrist who has an active license. . . . [and] does not include a licensee who is an employee . . . of a pharmaceutical Manufacturer who does not provide patient care.”
Analysis
The update to the regulation provides additional clarity on the scope of the rule which was passed on on the last day of the Christie administration. The rule still holds drug-specific promotional talks to the $15/$30 meal limit with the exception of disease state education. The exemption for educational events will give NJ prescribers the opportunity to attend events across the country that may incidentally offer food without the concern that they are somehow breaking the law. According to Andy Rosenberg, JD at the CME Coalition “New Jersey has seen the value of CME and understands the independence and importance of educational events.” Hats off to Attorney General Grewal.