The state of New Jersey in the US has been active since 2017 in creating a gift ban essentially, the controlling of the amount a healthcare company can pay a Healthcare professionals (HCP) for services and for financial limits to meals. 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 which we have summarised below.

Please note these are our interpretations of the rules and should be used accordingly. To learn more contacts [email protected]

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:

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.

Bona Fide Services:

Payments for research activities and payments to prescribers for speaking at education events are not subject to the bona fide services cap.

Education Event:

The definition now includes (1) 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.

Healthcare-Venues: Our interpretation of an educational event it is any meeting or event that is non-promotional.

“Prescriber” Definition:

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.”

Healthcare-Venues: It will be interesting to see how companies interpret this to out of state meetings.

“Research” Definition:

Research means any study assessing the safety or efficacy of prescribed products administered alone or in combination with other prescribed products or other therapies, or assessing the relative safety or efficacy of prescribed products in comparison with other prescribed products or other therapies, or any *[systemic]* *systematic* investigation, including scientific advising on the development, testing, and evaluation, that is designed to develop or contribute to general knowledge, or reasonably can be considered to be of significant interest or value to scientists or prescribers working in a particular field. Research shall include both pre-market and post-market activities that satisfy the requirements of this definition.

Healthcare-Venues: Our interpretation is that investigator and associated research-based meetings are exempt

Reasonable Honoraria Proposed Definition:

Cash and/or a gift given to a practitioner in return for the practitioner speaking at a professional or educational conference sponsored by a manufacturer or wholesaler. The aggregate value of all cash and gifts received by a practitioner for a particular speaking engagement may not exceed an annual limit of $250 in retail value.

Modest Meals and Refreshments Proposed Definition:

Food and beverage of minimal value provided to a practitioner in connection with a meeting or presentation about the benefits, risks, and appropriate uses of prescription drugs or medical devices, disease states, or other scientific information as long as the meeting or presentation occurs in a venue and manner conducive to informational communication. Such food and beverage must be of the type and quantity typically provided for conference attendees at the venue where the meeting or presentation occurs.

Reasonable Expenses Proposed Definition:

The reasonable and actual expenses for travel, lodging, and meals incurred by a practitioner and that are necessary in order for the practitioner to speak at a professional or educational conference sponsored by a manufacturer or wholesaler. Healthcare-Venues: we wish organisations would not use words like “minimal value” to avoid confusion and differing interpretations.

These points have not yet been ratified to date. An open meeting on 08 May 2019 is planned to debate this and other topics. To stay in touch with news on the Maine honoraria limits sign up to our news here or email us here.