Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions
In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions between prescribers and drug manufacturers. Although the rule itself has not yet been released, according to a press release from the Office of the Governor, the proposed rule would:
- Permit, but limit, the provision of "modest meals" in certain settings for learning to $15 per prescriber four times each year from each manufacturer;
- Prohibit receipt of cash, gift cards, entertainment and recreational items for personal use, and payments supporting non-faculty attendance at promotional activities and continuing education events;
- Establish exemptions to these "gift bans" where the purpose is for the benefit of the patient or the education of the prescriber, such as educational materials;
- Set standards for agreements for "bona fide services," i.e., speaking at promotional activities and continuing educational events, participation on advisory boards and consulting agreements;
- Require "bona fide service" agreements to be in writing with dollar amounts and an "articulation" of the prescriber's expertise;
- Cap the compensation for "bona fide services" from all manufacturers to $10,000 per calendar year per prescriber (with an exception for speaking at continuing education events).
However, unlike other state "gift ban" laws that focus on industry, the New Jersey proposed rule makes prescribers accountable by couching the restrictions as a clarification of existing limitations on licensees of the Boards of Medical Examiners, Dentistry and Optometry and extending them to Advanced Practical Nurses. Indeed, according to Attorney General Chris Porrino, "The rule would prohibit doctors from forming unsavory financial relationships with drug companies that manufacture highly additive opioids. It also gives the state professional boards enforceable standards to hold doctors accountable if they violate the rule."
Adoption of this rule, as it is described in the press release, would add to the patchwork of state-specific limitations on value-transfers, increasing the complexity of establishing consistent national compliance standards. Also, this is the first "gift ban" rule that we are aware of capping compensation for "bona fide services." Unless the ultimate rule embodies exceptions—for example, for services as a principal investigator and other valuable professional services normally provided by physicians—it could have severe implications for research and development of pharmaceuticals in New Jersey.
The rule was announced on International Opioid Crisis Overdose Awareness Day, and follows a 2016 Centers for Medicare and Medicaid Services report showing that two-thirds of $69 million dollars paid by pharmaceutical companies to New Jersey doctors went to just 300 physicians. The rule aims to curb the undue influence of the pharmaceutical industry on prescribers and the unnecessary prescription of powerful pain killers.
The rule will be published on October 2, 2017 in the New Jersey Register. A hearing will be held on October 19 for public comment.