What happened?
On December 22, 2017 New Jersey’s Attorney General, Christopher S. Porrino, finalized new rules that would place limitations on accepted compensation from pharmaceutical manufacturers or their agents by prescribers. The new rule, entitled “Proposed New Rule N.J.A.C. 13:45J, Limitations On and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers”, is intended to curtail most transfers of value from industry to prescribers including physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists. The rule amends regulations to limit these gifts in an attempt to prevent any “conflicts of interest” between pharmaceutical manufactures and providers authorized to prescribe in the state of New Jersey. It took effect January 15, 2018.
On December 22, 2017 New Jersey’s Attorney General, Christopher S. Porrino, finalized new rules that would place limitations on accepted compensation from pharmaceutical manufacturers or their agents by prescribers. The new rule, entitled “Proposed New Rule N.J.A.C. 13:45J, Limitations On and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers”, is intended to curtail most transfers of value from industry to prescribers including physicians, podiatrists, physician assistants, advanced practice nurses, dentists, and optometrists. The rule amends regulations to limit these gifts in an attempt to prevent any “conflicts of interest” between pharmaceutical manufactures and providers authorized to prescribe in the state of New Jersey. It took effect January 15, 2018.
Who is impacted?
For the purposes of the rule, most payments would be limited or prohibited from "pharmaceutical manufacturer's agents" or "manufacturer's agents" meaning a person who, “while employed by, or under contract with, a pharmaceutical manufacturer, engages in detailing, promotional activities, or other marketing of prescription drugs or biologics to any prescriber authorized to prescribe, dispense, or purchase prescription drugs, biologics, healthcare facility, or pharmacist, but shall not include a prescriber or pharmacist when acting within the ordinary scope of the practice for which he or she is licensed.”
Generally speaking, this rule should not apply to accredited CME providers.
Why should CME providers care about this rule?
Although the rule explicitly only applies to payments or value transfers from manufacturers and manufacturers’ agents, it appears to create exemptions for “education” including CME, without addressing the fact that CME must be independent. As such, this may create some confusion as to the application of these rules to independent commercially-supported CME.
For example, among the so-called “permitted gifts and payments,” prescribers may accept from industry are:
Conclusion
Unless your organization meets the definition of manufacturer or manufacturer’s agent, this rule should not apply to payments you make. However, New Jersey physicians may be confused as to why the CME-related prohibitions and limitations embedded in the rule may not apply to your activities.
For the purposes of the rule, most payments would be limited or prohibited from "pharmaceutical manufacturer's agents" or "manufacturer's agents" meaning a person who, “while employed by, or under contract with, a pharmaceutical manufacturer, engages in detailing, promotional activities, or other marketing of prescription drugs or biologics to any prescriber authorized to prescribe, dispense, or purchase prescription drugs, biologics, healthcare facility, or pharmacist, but shall not include a prescriber or pharmacist when acting within the ordinary scope of the practice for which he or she is licensed.”
Generally speaking, this rule should not apply to accredited CME providers.
Why should CME providers care about this rule?
Although the rule explicitly only applies to payments or value transfers from manufacturers and manufacturers’ agents, it appears to create exemptions for “education” including CME, without addressing the fact that CME must be independent. As such, this may create some confusion as to the application of these rules to independent commercially-supported CME.
For example, among the so-called “permitted gifts and payments,” prescribers may accept from industry are:
- pharmaceutical manufacturer-subsidized registration fees at education events, if that fee is available to all event participants
- modest meals (under $15) provided through the event organizer at an education event, provided the meals facilitate the educational program to maximize prescriber learning
- compensation, based on fair market value, for providing bona fide services as a speaker or faculty organizer or academic program consultant for an education event. A prescriber serving in this capacity may also accept reasonable payment and remuneration for travel, lodging, and other personal expenses associated with such services.
Conclusion
Unless your organization meets the definition of manufacturer or manufacturer’s agent, this rule should not apply to payments you make. However, New Jersey physicians may be confused as to why the CME-related prohibitions and limitations embedded in the rule may not apply to your activities.
