Thursday, January 8, 2015

Petition for Rulemaking – Medical Marijuana Regulations

October 14, 2014

Mary O'Dowd, Commissioner
New Jersey Department of Health
P.O. Box 360
Trenton, NJ 08625-0360

Re:  Petition for Rulemaking – Medical Marijuana Regulations

Dear Commissioner O’Dowd:

Pursuant to N.J.A.C. 1:30-4.1, the Coalition for Medical Marijuana--New Jersey petitions for modifications to the existing regulations to provide effective access to medical marijuana for patients and specifically hospice patients. The petitioner seeks modifications to the existing regulations to comport with the statutory scheme and, for example, eliminates requirements such as doctor registration which is not required by the Compassionate Use Act. 

Full name and address of the petitioner.
Coalition for Medical Marijuana—New Jersey, Inc.
219 Woodside Avenue
Trenton, NJ 08618.  Tel.  609-394-2137.

The nature and substance of the rulemaking request
Petitioners request that the Department of Health (DOH) modify certain medical marijuana regulations as explained in this petition.  The proposals herein seek modification of the existing regulations to allow adequate access to medical marijuana for qualified patients as intended by the Compassionate Use Act by:

a.  Eliminating the $200 fee required in N.J.A.C 8:64-2.1(f) for all volunteer caregivers and eliminate the illegal sales tax on medical marijuana. 

b.  Deleting the clearly ultra vires registration requirement for doctors contained in N.J.A.C. 8:64-2.4, as well as the unwarranted course requirement in pain management in order for licensed physicians to recommend medical marijuana. 

c.  Eliminating the regulatory requirement in NJAC 8:64-2.5(a)6 which requires physicians to violate patient confidentiality and in (a) 9 of that section which interferes with the physician’s professional judgment.

d.  Eliminating the regulatory requirement in N.J.A.C 8:64-2.5(a)9i which requires physicians to provide warnings to patients that directly contradicts N.J.S.A 24:6I-2a.

e.  Adding as an additional qualifying debilitating condition Post Traumatic Stress Disorder (PTSD) to accommodate the influx of recent military service veterans inasmuch as the DOH failed to establish the panel as required by N.J.A.C 8:64-5.1 to add new conditions.   

f.  Eliminating the requirement in N.J.A.C. 8:64-2.5b for parents to seek the approval of three licensed physicians in order to obtain medical marijuana for their child.

The reason and basis for the request  
The below sub-paragraphs parallels those used in Paragraph 2 above.

a.  Most if not all the caregivers involved are volunteers who already have to pay for background checks and should not pay to render a necessary service to seriously ill patients. Moreover, there are over 30,000 hospice patients in NJ, all of whom statutorily qualify for medical marijuana but are unnecessarily hindered by the requirement that each of their caregivers pay $200 for a simple registration.  Elimination of this cost would ease the burden on all patients and especially those in hospice care enabling them to access a much needed medication.  As to the tax, NJSA 54:32B-8.1 specifically exempts any prescribed or over the counter medication.  That statute broadly defines “drug” to be any substance or preparation “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or, “intended to affect the structure or any function of the body.”  No other medicine is taxed and this illegally treats marijuana used as medicine as an illegal drug--which it is not, when used pursuant to the Compassionate Use Act. The Technical Bulletin issued by the Division of Taxation on February 16, 2010--after passage of the Compassionate Use Act--recognized the expansion of the sales and use tax exemption for drugs. Nowhere does it even hint that there is any exception for medical marijuana. There is nothing in the Compassionate Use Act nor in the DOH’s Regulations regarding or even hinting at imposition of a sales tax.  This tax is blatantly illegal and the Regulation must reflect the non-taxable status of medical marijuana.   

b.  Fewer than 1% of the doctors in NJ have registered to provide medical marijuana.  This requirement is not in the statute and is entirely unnecessary.  All licensed New Jersey physicians are statutorily authorized in the Compassionate Use Act to authorize their patient’s use of medical marijuana.  Notably, such physicians are authorized to provide any patients in New Jersey with narcotics without any special registration with the DOH.  Additionally, there is no pain management course required for doctors to prescribe narcotics, which are far more dangerous than marijuana. Physicians are well aware that their right to prescribe narcotics is strictly controlled by the Federal Government.  Historically, the Federal Government has taken an adverse position to medical marijuana.  Although this position is possibly diminishing, there is no formal federal recognition of medical marijuana.  Thus, registration as a “pot doc” presents a real threat to a doctor’s right to prescribe narcotics. It thus poses a significant impediment to a doctor’s willingness to register as a medical marijuana provider, as documented by the few doctors willing to take the risk.

The legislature clearly did not intend for physicians to register or it would have so stated as it did for patients and caregivers.  The omission of physicians can only be seen as deliberate.  Section 6I-4 of the Act, specifically states that the department shall establish a registry of patients and primary caregivers.  Section 6I-5(a) of the act specifically states “in order to provide such certification, a physician shall be licensed and in good standing to practice in the state.”  Nowhere does the act even hint at a need for physicians, who are already licensed professionals, to register in order to recommend the use of marijuana. Logic, basic statutory interpretation and the reality of the situation all point toward no registration requirement for physicians.

c. There is no requirement in the act for doctors to provide any administrative agency with the specifics of the patient’s condition, diagnosis or course of treatment.  This is in accordance with Federal Law protecting patient’s rights to privacy. 

d. In the Compassionate Use Act, the legislature specifically stated that marijuana has been scientifically demonstrated to provide relief for certain conditions.  Section 6I-2a of the Act states: “Modern medical research has discovered a beneficial use for marijuana in treating or 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.”   In direct refutation of the legislature’s finding, the DOH’s regulation requires doctors to make statements about marijuana that are completely untrue, more befitting a “reefer madness attitude” rather than a mature regulatory implementation and contrary to express legislative declarations.  The fact that the Department believes there is no consensus does not trump the legislature’s recognition of the great benefits science has documented for marijuana.  As to the demanded education on the “risk of addiction” the DOH may wish to take note that marijuana has been equated to the addiction risk of caffeine. If there is to be a mandated statement it should include that virtually ALL the regularly used drugs present significant dangers to health and even life itself whereas marijuana, if it does not help, will almost certainly do no harm.

e. Reliable scientific evidence documents that marijuana is an effective treatment for post traumatic stress disorder (PTSD).  At the date of this application nine other states with medical marijuana programs have accepted its use to treat PTSD.  The DOH may wish to review studies documenting the science behind this position and to that end petitioner has attached a sampling of supporting sources (see Attachment).  If DOH desires, petitioner is prepared to submit numerous other sources. Thousands of New Jersey’s returning service members, suffering from PTSD and committing suicide in record numbers, would benefit from the use of medical marijuana.  Because the DOH has failed to follow the statutory mandate to form a panel to evaluate conditions, no conditions have been added in four years while these service members continue to suffer needlessly.  Again, as science documents, should marijuana not help the veteran, it will not harm him or her as will many other accepted treatments.

f.  In order to avoid additional financial and psychological burdens placed on families with children who benefit from the use of medical marijuana, petition requests elimination of N.J.A.C 8:64-2.5(b).  There is no requirement in the Compassionate Use Act that a minor requires not only a treating physician, but also a pediatrician and a psychiatrist before allowing use of medical marijuana.  The only requirement in Section 6I-5(b) of the Act is that the parent, guardian or legal custodian consents, and will control, acquisition and possession.  As a matter of fact, New Jersey has very few pediatric psychiatrists. Moreover, there is no benefit for a child possibly months old to have to undergo a psychiatric evaluation before allowing a treatment to stop life threatening seizures.  The regulation thus imposes not only an extremely expensive, entirely unnecessary burden but one not in accordance with the Act.  This is nothing less than an insult to parents who are solely acting in the best interest of their seriously ill child and an example of cruel bureaucratic overreaching.

SUMMARY
As currently written, the regulations not only fail to comport with both statutory language and intent, they intentionally serve to block patient access to a necessary medicine.  None of the requested changes poses any danger to the public or to patient welfare.  On the contrary, allowing the medical marijuana program to function as intended by the Act will divert patients from the illegal, and therefore wholly unregulated, drug market which these defective Regulations force upon them.  The current dysfunctional state of the program is well documented and that is solely because the Regulations fail to meet the documented needs of suffering people as intended by the Compassionate Use Act. 

As the alternative treatment centers (ATCs) themselves have pointed out, the impediments to patient access have caused serious damage to their ability to function.  If access were provided in accordance with the strict statutory mandates, the ATCs would be economically viable enterprises.  As the situation stands now, only two ATCs function with any regularity and the other ATC cannot provide any set times of operation.  The unnecessary and ultra vires burdens on access imposed by the existing regulations have forced most qualified patients to continue to rely on illegal black market sources for their marijuana.  This is a disgrace and the antithesis of the statutory intent that patients not be forced to become criminals. 

The petitioner’s interest and request, including without limitation, any relevant organizational affiliation or economic interest  
The Coalition for Medical Marijuana—New Jersey is a 501(c)(3) non-profit organization formed and devoted to insuring that New Jersey patients have access to medical marijuana as authorized by law.  Members of the coalition testified at all legislative hearings leading up to the enactment of the Compassionate Use Act and provided evidence of scientific acceptance.  During this time and continuing to present, the Coalition has met with and discussed marijuana access and use with thousands of patients.  It is well acquainted with complaints from both patients and doctors which generated this petition for rulemaking to address their concerns. Although the Coalition cooperates with any person or entity advocating for patient access, it has no affiliations.  Similarly, the Coalition has no economic interest in the proposed changes to allow greater patient access other than eliminating the need to raise funds to fight for patient access.

The statutory authority under which the department may take the requested action  
The DOH was authorized by the Compassionate Use Act, NJSA 24:6I-16 to “promulgate rules and regulations to effectuate the purposes of this act, in consultation with the Department of Law and Public Safety.”

Emphasis should be placed on the phrase “to effectuate the purposes of this act.”   The statute specifically provides that marijuana is a legitimate medical treatment and should be made readily available to patients suffering from conditions enumerated in the statute. Under the current regulations this has not happened and without necessary changes, it will not happen, in direct contradiction to the clear statutory intent. 

Conclusion
For the reasons stated above, the petitioner respectfully requests the adoption of the rule modifications as explained above.

Respectfully submitted,

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

Attachment

Attachment
Research supporting use of cannabis to treat symptoms of PTSD
1.    Mashiah M, “Medical Cannabis as Treatment for Chronic Combat PTSD: Promising Results in an Open Pilot Study” Abarbanel Mental Hospital, Israel presented at Patients out of Time Conference, Tuscon (2012)
2.    Passie T, Emrich H, Karst M, Brandt, Halpern J, “Mitigation of post-traumatic stress symptom byCannabis resin: A review of the clinical and neurobiological evidence” Drug Testing and Analysis  (2012) 649-659
3.    Fraser G, “The Use of a Synthetic Cannabinoid in the Management of Treatment-Resistant Nightmares in Posttraumatic Stress Disorder (PTSD)” CNS Neuroscience & Therapeutics 15 (2009) 84-88
4.    Pacher P, Baktaim Kunos G “The Endocannabinoid System as an Emerging Target of Pharmacotherapy” Laboratory of Physiologic Studies, National Institute of Alcohol and Alcoholism,  National Institutes of Health (2006) 58 389-462
5.    Ware M, Wang T, Shapiro S, Robinson A Ducruet T, Huynh T, Gamsa A, Bennett G, Collet J-P“Smoked cannabis for chronic neuropathic pain: a randomized controlled trial” Canadian Medical Association Journal (2010) 182(14)
6.    Abrams DI, Couey P, Shade SB, Kelly ME, Benowitz NL “Cannabinoid-Opioid Interaction in Chronic Pain” Nature Publishing Group (2011) 90(6) 844-851
7.    Fusar-Poli P et al., “Distinct effects of delta 9-tetrahydrocannabinol and cannabidiol on neural activation during emotional processing”, Archives of General Psychiatry (2009) 66: 95-105
8.    Chhatwal JP et al., “Functional interactions between endocannabinoid and CCK neurotransmitter systems may be critical for extinction learning”, Neuropsychopharmacology (2009) 34: 509-521
9.    Chhatwal JP et al., “Enhancing cannabinoid neurotransmission augments the extinction of conditioned fear”, Neuropsychopharmacology (2005) 30: 516-524
10.  Lin HC et al., “Effects of intra-amygdala infusion of CB1 receptor agonists on the reconsolidation of fear-potentiated startle”, Learning & Memory (2006) 13: 316-321,
11.  Pamplona FA et al., “The cannabinoid receptor agonist WIN 55,212-2 facilitates the extinction of contextual fear memory and spatial memory in rats”, Psychopharmacology (Berlin) 188: 641-649, 2006
12.  Resstel LB et al., “5-HT receptors are involved in the cannabidiol-induced attenuation of behavioural and cardiovascular responses to acute restraint stress in rats” British Journal of Pharmacology (2009) 156: 181-189


46 NJR 12(1)
December 1, 2014
Filed November 10, 2014

PUBLIC NOTICE
HEALTH
THE COMMISSIONER
Notice of Receipt of Petition for Rulemaking
Revision of N.J.A.C. 8:64 Medicinal Marijuana Program Rules
Petitioner: Ken Wolski, RN, MPA, Executive Director, Coalition for Medical Marijuana - New Jersey, Inc., Trenton, NJ.

Take notice that on October 16, 2014, the Department of Health (Department) received a petition for rulemaking from Ken Wolski, RN, MPA, Executive Director of the Coalition for Medical Marijuana - New Jersey, Inc., of Trenton, New Jersey.

Substance or nature of the requested rulemaking action

The petitioner requests that the Department make certain amendments to N.J.A.C. 8:64, the Medicinal Marijuana Program rules.
N.J.A.C. 8:64 implements the New Jersey Compassionate Use Medical Marijuana Act (Act), N.J.S.A. 24:6I-1 et seq.

Problem or purpose of the request

The petitioner requests that the Department:
1. Eliminate the fee to apply for issuance or renewal of a primary caregiver identification card of $200.00 at N.J.A.C. 8:64-2.1(f);
2. Eliminate the sales tax on medical marijuana;2
3. Delete the requirement at N.J.A.C. 8:64-2.4 that physicians register with the Department to be eligible to submit a certification pursuant to N.J.A.C. 8:64-2.5;
4. Delete the “course requirement in pain management in order for licensed physicians to recommend medical marijuana”;
5. Delete N.J.A.C. 8:64-2.5(a)6, and 9, which establish some of the required content of a physician certification for a patient to be eligible to obtain medicinal marijuana from an alternative treatment center;
6. Add post-traumatic stress disorder (PTSD) to the definition of “debilitating medical conditions” at N.J.A.C. 8:64-1.2; and
7. Delete the part of N.J.A.C. 8:64-2.5(b) that petitioner characterizes as “requiring parents to seek the approval of three licensed physicians in order to obtain medical marijuana for their child.”

http://www.nj.gov/health/legal/petitions.shtml

1 comment:

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