In January 2018, New Jersey's former Attorney General adopted N.J.A.C. 13:45J (the "Compensation Regulation"), which prohibits all New Jersey prescribers - physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists (collectively "Prescribers") - from receiving or accepting anything of value from a pharmaceutical manufacturer, unless the transfer of value was specifically permitted in the regulation. On August 6, 2018, the current Attorney General ("AG") issued proposed amendments to the Compensation Regulation to clarify the scope and loosen restrictions on certain types of meals.
The proposed revisions would amend the definition of Prescriber to require that the Prescriber hold an active New Jersey license and that the regulation only apply to Prescribers who either practice in New Jersey or have New Jersey patients, regardless of where the Prescriber's practice is located.
The proposed revisions would modify the definition of modest meal by increasing the allowable universal fair market value from $15 to $30 for dinner, while maintaining the $15 limit for breakfast and lunch. Additionally, the proposed revisions would allow annual adjustments in the modest meal cap in dollar increments starting in 2019 based upon the Consumer Price Index for Food Away From Home-Northeast Urban area, as determined by the U.S. Department of Labor Bureau of Labor Statistics. Importantly, the AG seeks to remove delivery, facility rental, or tax costs from the fair market value of modest meals calculation.
Further, the proposed revisions would allow Prescribers to accept meals provided through an education event organizer, even if supported by a manufacturer. Such meals would not be subject to the fair market value cap or to the bona fide services cap, and would not be subject to the modest meal limits. The fair market compensation cap for bona fide services remains at $10,000 per year in the aggregate from all manufacturers in a calendar year.
Finally, the proposed revisions would provide that modest meals made available to non-faculty prescribers via promotional activities are not subject to the bona fide services cap.
Interested stakeholders may submit written comments by October 5, 2018, to:
Maryann Sheehan, Director, Legislative and Regulatory Affairs
Division of Consumer Affairs
124 Halsey Street, 7th Floor
PO Box 45027
Newark, NJ 07101
Comments may also be submitted electronically by clicking here.
To view a copy of the proposed rule changes, please click here.
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