AG Grewal, Division of Consumer Affairs Announce Three Rulemaking Actions Addressing the Opioid Epidemic Rulemakings Focus on Prevention, Education, and Treatment
TRENTON, NJ: Office of Attorney General reports 5.7.2019 – Attorney General Gurbir S. Grewal and the New Jersey Division of Consumer Affairs, together with the New Jersey Coordinator for Addiction Responses and Enforcement Strategies (“NJ CARES”), today announced a series of regulatory actions that will advance the State’s battle to end the opioid epidemic, including proposed rules that will expand access to the prevention and treatment of opioid use disorder through telemedicine.
The proposed telemedicine rules, published in the New Jersey Register today, establish standards for medical doctors and podiatrists who provide health care services – including the treatment of opioid use disorder – by means of telecommunications technology.
“Making medication-assisted treatment more widely accessible through telemedicine removes the barriers to care that many individuals suffering from addiction now face and allows doctors to provide treatment to more people,” said Attorney General Grewal. “This proposed rule is the latest example of how New Jersey is wielding its regulatory authority as a powerful tool in the fight to end the opioid crisis.”
Two other regulatory initiatives that address New Jersey’s addiction epidemic were adopted today.
The first amends rules for NJ Prescription Monitoring Program (“NJPMP”), mandating increased use of the centralized database and making it easier for prescribers to fulfill their duty to monitor use of opioid painkillers and other controlled drugs that can lead to addiction and fatal overdoses.
The second amends rules concerning limitations on, and obligations associated with, prescribers’ acceptance of compensation from pharmaceutical companies. The amendments – which include increasing the allowable amount for dinner and specifying that meals associated with education events are not subject to limitation – are aimed at furthering the educational exchange between practitioners and pharmaceutical manufacturers for the benefit of patient care.
“Enhancing health care providers’ ability to identify, treat, and prevent substance use disorders in patients is an important part of our multi-pronged approach to combat the addiction crisis,” said Sharon M. Joyce, Director of NJ CARES. “The regulatory initiatives announced today support and advance that strategy.”
“Members of the health care community have mobilized to help fight the addiction crisis,” said Paul R. Rodríguez, Acting Director of the Division of Consumer Affairs. “The Division is committed to providing a strong regulatory framework to assist them in this important effort.”
Proposed Rules for Telemedicine
The State Board of Medical Examiners within the Division of Consumer Affairs today proposed rules to implement a law that authorizes New Jersey health care providers to offer telemedicine services. The proposed rules would, among other things:
- address licensure for practitioners of telemedicine or telehealth;
- govern the licensee-patient relationship in the telemedicine or telehealth setting;
- require licensees to use interactive, real-time, two-way communication technologies, which include a video component, when providing services through telemedicine;
- require licensees who provide services through telemedicine or telehealth to provide contact information to a patient by which the patient can contact the licensee, or an alternative licensee, for at least 72 hours after the provision of services;
- prohibit a licensee from issuing a prescription based solely on the responses to an online questionnaire, unless a licensee has established a licensee-patient relationship with the patient;
- prohibit a licensee from issuing a prescription for a Schedule II controlled dangerous substance unless the licensee has an initial in-person examination of the patient and sees the patient in-person at least every three months during the time the patient is prescribed the substance; and
- require licensees to establish privacy practices for electronic communications.
New Rules for the NJ Prescription Monitoring Program
New rules adopted today broaden conditions under which practitioners are required to look up patient records on the NJPMP prior to prescribing opioid pain medication.
The NJPMP is a centralized data sharing system that tracks prescription sales of opioids and other controlled dangerous substances (“CDS”). The information contained in the database can help prescribers and pharmacists provide better care and identify signs that individuals are abusing or diverting prescription medications.
The new rules add lookup requirements for prescriptions written in hospital emergency rooms, after procedures such as wisdom teeth removal, and in other situations. Additionally, the new rules expand the types of drugs that trigger look-up requirements to include all opioids, not just those in the most tightly restricted “Schedule II” category.
And for the first time, physicians must check the NJPMP before prescribing benzodiazepines, a class of sedative drugs like Xanax, Ativan, and Klonopin that, when taken in combination with opioids, increase the risk of a fatal overdose.
In addition to expanding the conditions under which a prescriber is required to look up patient records on the NJPMP, the newly adopted rules also expand access to the prescription database.
Direct access to the NJPMP is limited to prescribers and pharmacists, but prescribers may delegate their access authority to other healthcare professionals who can make the checks for them.
The new rule expands delegate access to include athletic trainers in a clinical setting and medical scribes employed by a hospital’s emergency department.
Amendments to Rules Limiting Prescribers’ Acceptance of Compensation from Drug Manufacturers
Rules adopted in January 2018 to curb pharmaceutical companies’ influence on prescribers were amended today to further the educational exchange between practitioners and pharmaceutical manufacturers for the benefit of patient care.
The prior rules imposed a $15 limitation on meals that could be provided at an education event or promotional activity. Since the enactment of these rules, many have expressed concern about the impact of the modest meals limitation on the availability of venues conducive to a learning environment.
Today’s amendments specify that the fair market value limitation remains $15 for breakfast or lunch, but is increased to $30 for dinner. These dollar amounts were established in 2018 and are subject to potential annual increases based on changes in the Consumer Price Index. The amendments also make it clear that the fair market value does not include the cost of standard delivery, service, or facility rental fee charges, or of tax.
Recognizing that prescribers may benefit from educational programs, the amendments also removed any limitation on the value of meals provided through the event organizer at an education event, as long as the meals facilitate the educational program to maximize prescriber learning. Meals provided by a pharmaceutical manufacturer to non-faculty prescribers through promotional activities will remain subject to the modest meal limitations.
The rule changes are designed to ensure that prescribers can participate in learning opportunities that will enhance patient care.