Wednesday, August 15, 2018

Comments on the Proposed Regulations from the NJ Department of Health, Division of Medicinal Marijuana

Medical Marijuana patients greatly appreciate the obvious effort the personnel of the Department of Health (Department) expended in rescuing the Medicinal Marijuana Program (MMP) from the currently often cruel and counterproductive regulations.  Many regulations were designed to delay the program’s implementation and severely limit patient access.  The Coalition for Medical Marijuana—New Jersey, Inc. (CMMNJ) applauds the current proposal which resonates with a refreshing commitment to patient welfare.

CMMNJ’s intent is to seek to improve what is already an excellent proposal and far superior to the existing regulations.  We base our comments on years of listening to concerns raised by patients, information gained through other state programs and insights provided by our experts.  Based on the tenor of the regulatory proposal, we have every confidence that the Department will give full and fair consideration to our comments and concerns in the interests of benefitting patients, which we all agree is the purpose of this enactment.  We have provided what we trust are adequate rationales for each of our recommendations but would be pleased to answer any questions the Department may have.

In the Summary of the Department of Health’s Proposed Readoption with Amendments of N.J.A.C 8:64, the Department notes on page 4:
"P.L. 2015, c. 158 (approved November 9, 2015), at § 1, established N.J.S.A. 18A:40-12.22, which requires those in charge of schools to establish policies for the administration of medicinal marijuana, by means other than smoking and inhalation, to students, if they are “qualifying patients” within the meaning of the Act, while they are on school grounds and buses, and at school-sponsored events. P.L. 2015, c. 158, § 2, established N.J.S.A. 30:6D-5b, which requires administrators of facilities offering services for persons with developmental disabilities to establish policies for the administration of medicinal marijuana to those persons, if they are facility clients and “qualifying patients” within the meaning of the Act, while they are on facility premises."
What is missing is an evaluation of how this law is working. How many patients in schools and facilities for the developmentally disabled qualify for medical marijuana?  How many of these patients are actually receiving medical marijuana as a result of this law? Are caregivers actually able to come to these facilities one or more times a day to administer medical marijuana to qualifying patients? Families of patients typically report that these patients are not getting the medical marijuana that they require in order to control their serious medical conditions (seizures, chronic pain, anxiety, etc.) Thus, the clear intent of this law is being frustrated by the inability of caregivers/family members to report to these facilities one or more times a day to administer medical marijuana. On the other hand, staff at these facilities are trained to safely administer and account for other controlled substances. The staff of these facilities should be empowered to administer medical marijuana as well, to relieve the families of this burden while meeting the needs of the patients, in compliance with the intent of the law.

In the Summary of the Department of Health’s Proposed Readoption with Amendments of N.J.A.C 8:64, the Department notes on page 6:
"On January 23, 2018, Governor Murphy issued Executive Order No. 6 (EO 6), in which he directed the Department and the Board of Medical Examiners to “undertake a review of all aspects of New Jersey’s medical marijuana program, with a focus on ways to expand access to marijuana for medical purposes.”
The Department’s Executive Order 6 Report (Issued by Acting Commissioner Shereef Elnahal, M.D., M.B.A. on March 23, 2018) is clear and welcome. What is missing is the report from the New Jersey Board of Medical Examiners (BME). Is this report forthcoming? On 7/3/18, CMMNJ sent an email to the BME asking them about their missing input from EO 6 and they have not had the courtesy to reply. CMMNJ certainly hopes they treat the governor with more respect. The EO 6 Report notes that:
“There are 523 MMP-approved physicians throughout the State (as of February 15, 2018), (while) only 79% are actively writing patient statements and treating patients.” 
There are approximately 28,000 physicians in New Jersey, so less than 2% of the total New Jersey physicians are participating in the MMP. This is an unacceptable level of physician participation in the MMP that the BME and the Department must address. Currently patients must search the Department web site for a physician to recommend marijuana for them. Typically, these physicians charge cash (usually over $100) for each visit as they contend that a patient’s health insurance does not cover medical marijuana. Additionally, patients are required to return to the participating physician every 30, 60 or 90 days for a renewal of the medical marijuana recommendation. This is an added and unnecessary expense for many of the New Jersey medical marijuana patients who already have to contend with the most expensive medical marijuana in the U.S. The Department is currently developing “Provider Education Program and Dosing Guidelines.” The Department notes that:
“With the expansion of authorized debilitating conditions, the Department recognizes the need to provide education and guidance to providers. To that end, the Department is exploring the creation of an education program for all physicians, with focus on the endocannabinoid system (ECS).” 
There are already a number of educational programs on the ECS that are approved for Continuing Medical Education (CME) credits for physicians. The Department should adopt one of these programs immediately, and require mandatory ECS education for all physicians in New Jersey who have prescription privileges as a condition of continued licensure in the state. A great many more people in New Jersey are going to be using marijuana in the near future and it is incumbent upon prescribers to be familiar with how marijuana works in conjunction with traditional therapies in controlling and managing health problems. Additionally, the Department should allow anyone in New Jersey who has prescription privileges, including Advance Practice Nurses, Physician’s Assistants, Dentists and Veterinarians, to recommend medical marijuana. Marijuana is part of mainstream medicine, despite the fact that 98% of New Jersey physicians have shown little or no interest in learning about the ECS, a system that interacts with all the other systems in the body and a system that may well play a role in all disease processes affecting humans and animals.

All References are to NJAC 8:64:

Sec. 2.2 “Application for registration as a qualifying patient”: (g) (Proposed) In recognition of the fact that New York, Pennsylvania, Delaware and a total of 30 states now have medical marijuana laws, the Department shall recognize current, valid medical marijuana ID cards that are issued by any other state in the country, and these patients shall not be subject to criminal penalties for possession and use of marijuana that is consistent with New Jersey’s regulations.

Sec 2.5 “Physician certification…(c) A physician may issue multiple written instructions at one time authorizing the patient to receive a total of up to a 90-day supply.” This amounts to a needless expense for a number of patients who suffer from life-long debilitating medical conditions. It should be extended to allow for either a 6-month supply, or better still, left up to the authorizing physician in consultation with the patient to determine when a return visit is appropriate.

Sec 2.5 (a) 9: Requires that the physician educate the patient “on the lack of scientific consensus for the use of medical marijuana, its sedative properties, and the risk of addiction.”  The Compassionate Use Medical Marijuana Act (Act) stands in direct contradiction to this unwarranted requirement when it states:
“Modern medical research has discovered a beneficial use for marijuana in treating of alleviating the pain or other symptoms associated with certain debilitating medical conditions, as found by the National Academy of Sciences’ Institute of Medicine in March 1999.”  (C.24:6I-2a)
Thus, the Act directly contradicts the required, disingenuous assertion. In recorded human history, there has never been a single fatality from the use of marijuana. It is impossible to fatally overdose on marijuana. Nor is the risk of addiction a major concern with marijuana. After stopping, less than 10 percent of users experience noticeable withdrawal symptoms even after heavy, long-term use of marijuana. These withdrawal symptoms, when noticed, are typically mild and include irritability and sleep disturbance. There are no serious withdrawal symptoms like those noted with alcohol (delirium tremens or DTs, seizures, death); heroin (flu-like symptoms); or nicotine (intense craving). The addiction potential for marijuana is about equivalent to that of caffeine. Let’s be clear that there is no lack of scientific consensus on the existence of the ECS, its role, and its importance in managing diseases, medical conditions and symptoms, at least among those who study the issue. What lack of consensus there is for the use of medical marijuana is a direct result of the federal government’s refusal to allow any large-scale clinical trials of marijuana. While there have been successful, small scale clinical trials of marijuana, the federal government continues to obstruct research into the benefits of medical marijuana. Thus, physicians in New Jersey are required to make a political statement about marijuana without a thorough explanation of why a lack of scientific consensus on medical marijuana exists. One might also argue that now, with 30 of 50 states having medical marijuana programs, there is indeed a consensus, scientific as well as popular, on the use and benefits of medical marijuana.

Sec. 3.4 (c): In comments, this limits caregiver to marijuana only from the ATC named on the registry ID card. This needs to be changed to allow flexibility for quick changes between ATCs, without the need for a new card. The reality is that caregivers report they can already change their ATC without getting a new ID card. Please note there is NO Sec. 3.4 in the published proposed Regulations (pages 51-52) (?)

Sec. 9.6: The Department wisely recommends no change to the “Alcohol and drug-free workplace policy” for ATCs, which includes, “1. The policy’s inapplicability if an employee, who is also a qualifying patient, fails the drug test solely because of the presence of marijuana in a confirmed positive test result.” Indeed, this workplace protection for medical marijuana patients should become the standard for all businesses in New Jersey. It makes no sense to penalize a patient in the workplace for using the very physician-recommended medication that, in many cases, allows that employee to participate in the workplace in the first place.

Sec. 10.12: Continues the prohibition on home delivery. This is unacceptable and must be eliminated and home delivery expressly permitted.

Sec. 11.4: Requires the ATCs to develop standards for documenting patient self-assessment. In order to ensure standardization, the Department should provide the standards and specifically a questionnaire.

Sec 13.4: Adopt “Patient Focused Certification” in order to bring national standards to every aspect of the MMP (testing, etc.) through Quality Assurance audits using the industry’s best technical experts:

CMMNJ proposes the addition of patient/caregiver home cultivation under stringent controls:

(Proposed) Sec. 8:64-13.12 In recognition of the facts that there are an insufficient number of ATCs to serve the existing patients; and, there is a greatly expanding patient need for medical marijuana; and, the ATC prices for medical marijuana exceed what many patients can afford (as well as what the illegal market charges); and, the Act provides for patient access from ATCs but does not prohibit patient growing; and, there is a greater need for stringent control over growers for general consumption that are not necessary for individual patients growing for themselves; and, not all strains necessary for patients are available from ATCs when needed by the patients; and, the very act of cultivating medical marijuana may itself provide therapeutic benefit to patients; and, the majority of states that have medical marijuana programs in the country allow home cultivation by patients; and, in recognition of the fact that the state is moving toward legalization of marijuana for recreational use; now therefore, patients or their registered caregivers shall be allowed to apply to the Department for a permit to grow up to 6 marijuana plants on the conditions that follow.

Sec.8:64-13.12 a. A patient who qualifies for a MMP ID card shall provide a completed DOH self-grow application and pay a fee to the DOH of up to $60 to apply for the self-growing permit ($10 per plant). 
b. The DOH shall review the application, decide, and notify the applicant within 60 days whether it will or will not authorize a self-grow permit.  If the DOH grants a permit, it shall be expressly limited solely to the patient’s personal use and any other distribution shall subject the patient to any applicable penalties as well as withdrawal of the privilege and revocation of their patient registration.
c. The permit shall be effective for one year and shall limit the applicant to a maximum of 6 mature plants. Each plant shall bear a tag issued by the DOH that identifies the plant as legally permissible to law enforcement officers. Plants shall only be cultivated indoors in a room or area that can be locked.
d. The applicant shall apply for a renewal each year at least 60 but no more than 90 days before the permit is scheduled to expire. 

Thank you for the opportunity to comment on the proposed medical marijuana regulations from the New Jersey Department of Health Division of Medicinal Marijuana.

Ken Wolski, RN, MPA
Executive Director
Coalition for Medical Marijuana--New Jersey, Inc.
219 Woodside Ave.
Trenton, NJ 08618

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