New Jersey’s Commissioner of Health and Senior Services Discusses Medical Marijuana and Two Other Regulatory “Case Studies” at Seton Hall Law
On Tuesday, March 1, 2011, New Jersey’s Commissioner of Health and Senior Services Dr. Poonam Alaigh gave a lively and illuminating talk to an audience from within and outside the Seton Hall Law School community. Reflecting her medical training, Dr. Alaigh organized her talk around three “case studies”: (1) the implementation of the New Jersey Compassionate Use Medical Marijuana Act; (2) the rulemaking procedure to amend the hospital licensing standards relating to nurse anesthetists; and (3) the decision by the Department of Health and Senior Services to defer implementation of New Jersey’s menu-labeling law. Two central themes of Dr. Alaigh’s presentation were the remarkable complexity of the legislative and rulemaking processes and the importance of a patient-centered approach to healthcare regulation.
The bulk of Dr. Alaigh’s presentation addressed the unusually extensive back-and-forth between the Department and the Legislature that has characterized the implementation of New Jersey’s medical marijuana law. After the New Jersey Senate invalidated the Department’s initial set of draft regulations, on the grounds that they “would not comply with the intent of the law and would make it much too difficult for eligible patients to access relief through marijuana,” the Department promulgated a revised set of draft regulations reflecting the terms of a bi-partisan compromise. Dr. Alaigh described the massive effort she and her staff — at times, she said, her entire staff — have made to educate themselves about both the science supporting the use of marijuana for medical purposes and the experience of other states with medical marijuana laws. Dr. Alaigh believes the result of the Department’s hard work is a regulatory regime that serves patients in need while avoiding the fraud and criminal diversion problems experienced in California and Colorado. She described New Jersey’s medical marijuana program as the “gold standard” and said that the Department has fielded calls from officials in other states interested in adopting something similar. Among the unique elements of New Jersey’s program is a registry of de-identified patient treatment and outcomes data that will allow researchers to learn more about marijuana’s safety and efficacy.
Dr. Alaigh also spoke about the Department’s rulemaking amending the hospital licensing standards relating to nurse anesthetists. On the one hand, Dr. Alaigh explained, nurse anesthetists are advanced practice nurses who by statute do not require the supervision of a doctor. On the other hand, Dr. Alaigh knows from practice how quickly a patient’s condition can turn critical while under anesthesia. The final regulation provides that nurse anesthetists can administer anesthesia in a hospital setting in accordance with a joint protocol that ensures that an anesthesiologist (1) is available at all times for consultation and (2) is physically present “during induction, emergence and critical change in status.” Dr. Alaigh noted that this result was not likely to have made either anesthesiologists or nurse anesthetists happy. A sign of success for a regulator, perhaps?
The third and final case study that Dr. Alaigh discussed was the Department’s decision not to promulgate draft regulations implementing New Jersey’s menu-labeling law and instead to wait for the federal Food & Drug Administration to implement the menu-labeling provisions of the Patient Protection and Affordable Care Act. As Dr. Alaigh explained in a post on her blog, “[p]ausing to see what the FDA proposes in nine weeks is reasonable. It avoids unnecessary duplication and costs for restaurant owners who would have to invest in new menus and then redo them when the federal rules supersede the state law.” That’s right, Dr. Alaigh has a blog, NJ Health Beat. You can keep up with her here.