Wednesday, January 19, 2011

Medical marijuana testimony planned at the Trenton, NJ State House on 1/20/11

WHO: Patients, medical marijuana advocates and potential Alternative Treatment Centers operators
WHAT: Plan to testify about the medical marijuana rules
WHEN: January 20, 2011 at 12:00 PM
WHERE: Trenton, NJ State House Annex Room #1
WHY: To protest the proposed rules from the DHSS and the Board of Medical Examiners

On Thursday, January 20, 2011 at 12:00 PM New Jersey medical marijuana advocates plan to testify at a Senate Health Committee hearing that will be held in Committee Room #1 in the State House Annex in Trenton, NJ. Doctors, nurses, patients, and potential Alternative Treatment Centers operators as well as other supporters of the New Jersey Compassionate Use Medical Marijuana Act will address the revised rules to implement the Medicinal Marijuana Program from the Health Department (DHSS).

Advocates and press are invited to meet in the Multi-Purpose Room in the Welcome Center of the State House Annex, which has been reserved for this purpose on January 20th from 11 AM to 4 PM.

The Coalition for Medical Marijuana--New Jersey has submitted an extensive comment on and critique of the revised rules from the DHSS. CMMNJ contends that “the people of this State cannot rely on DHSS to craft reasonable regulations to ensure safe and adequate access to medical marijuana. In its misguided efforts all DHSS has done is ensure that patients will be driven to the illegal drug market. This is exactly opposite to the basic goal of the law. Patients requiring effective marijuana, to which they are entitled under the Act, simply cannot expect to obtain it under these (rules). Thus, they must again choose between continued suffering or the commission of a crime to alleviate their suffering.”

CMMNJ is calling on the New Jersey State Legislature to rewrite these rules to ensure timely access to affordable, medical grade marijuana to qualified patients in a safe and secure manner.

CMMNJ was formed in 2003, is incorporated in New Jersey and is recognized as a 501(c)(3) by the federal government. CMMNJ is the only statewide organization solely dedicated to providing education and information about safe and legal access to medical marijuana, and it has closely followed the law’s evolution and patients’ concerns.

Ken Wolski, RN, MPA, Executive Director
Coalition for Medical Marijuana--New Jersey, Inc.
219 Woodside Ave., Trenton, NJ 08618
609.394.2137 www.cmmnj.org ohamkrw@aol.com

For more info, contact: Ken @ (609) 394-2137
Additional contact for further information: Chris Goldstein: media@cmmnj.org 505 577 5093(cell)

Medical marijuana testimony planned at the Trenton, NJ State House on 1/20/11

FOR IMMEDIATE RELEASE 1/19/2011
For more info, contact: Ken @ (609) 394-2137


Medical marijuana testimony planned at the Trenton, NJ State House on 1/20/11

WHO: Patients, medical marijuana advocates and potential Alternative Treatment Centers operators
WHAT: Plan to testify about the medical marijuana rules
WHEN: January 20, 2011 at 12:00 PM
WHERE: Trenton, NJ State House Annex Room #1
WHY: To protest the proposed rules from the DHSS and the Board of Medical Examiners

On Thursday, January 20, 2011 at 12:00 PM New Jersey medical marijuana advocates plan to testify at a Senate Health Committee hearing that will be held in Committee Room #1 in the State House Annex in Trenton, NJ. Doctors, nurses, patients, and potential Alternative Treatment Centers operators as well as other supporters of the New Jersey Compassionate Use Medical Marijuana Act will address the revised rules to implement the Medicinal Marijuana Program from the Health Department (DHSS).

Spoken testimony is limited to 3 minutes per person and written testimony must be submitted with 18 copies.

Advocates and press are invited to meet in the Multi-Purpose Room in the Welcome Center of the State House Annex, which has been reserved for this purpose on January 20th from 11 AM to 4 PM.

The Coalition for Medical Marijuana--New Jersey has submitted an extensive comment on and critique of the revised rules from the DHSS. CMMNJ contends that “the people of this State cannot rely on DHSS to craft reasonable regulations to ensure safe and adequate access to medical marijuana. In its misguided efforts all DHSS has done is ensure that patients will be driven to the illegal drug market. This is exactly opposite to the basic goal of the law. Patients requiring effective marijuana, to which they are entitled under the Act, simply cannot expect to obtain it under these (rules). Thus, they must again choose between continued suffering or the commission of a crime to alleviate their suffering.”

CMMNJ is calling on the New Jersey State Legislature to rewrite these rules to ensure timely access to affordable, medical grade marijuana to qualified patients in a safe and secure manner.

CMMNJ was formed in 2003, is incorporated in New Jersey and is recognized as a 501(c)(3) by the federal government.

CMMNJ is the only statewide organization solely dedicated to providing education and information about safe and legal access to medical marijuana, and it has closely followed the law’s evolution and patients’ concerns.

Ken Wolski, RN, MPA, Executive Director
Coalition for Medical Marijuana--New Jersey, Inc.
219 Woodside Ave., Trenton, NJ 08618
609.394.2137 www.cmmnj.org ohamkrw@aol.com

Additional contact for further information: Chris Goldstein: media@cmmnj.org

Tuesday, January 18, 2011

CMMNJ January 2011 Meeting Minutes & update

Monthly Public Meeting Minutes
Tuesday, January 11, 2011; 7:00 PM – 9:00 PM


7:00 PM: Call meeting to order. December 2010 minutes approved. Discussion:

DHSS publishes revised rules for the Medicinal Marijuana Program (MMP). New rules are still objectionable; Senate Health Committee to conduct public hearing on these rules on Thurs., 1/20/11 at the State House Annex at 1:00 PM. The Senate Health Committee will also conduct a hearing on the Board of Medical Examiners’ proposed rules. CMMNJ plans State House press conference prior to hearing. Please come to show support and testify—public testimony is welcome. Watch the www.cmmnj.org web site or Facebook for details.

DHSS publishes Request for Applications to run Alternative Treatment Centers. Applications must be in by 2/14/11 (before the end of the public comment period! See below.)

Association of Safe Access Providers, NJ (ASAP NJ), contact marianne.bays@gmail.com

69 NJ MDs have registered with the DHSS; 0.002% of NJ’s 30,000 MDs with current CDS registration. Will the public have access to this list of MDs who’ve registered for the MMP?

New public comment period ends 4/23/11. Submit written comments on the proposed DHSS rules, by regular mail, postmarked by April 23, 2011 to: Devon L. Graf, Director, Office of Legal and Regulatory Compliance, Office of the Commissioner, New Jersey Department of Health and Senior Services, PO Box 360 Trenton, NJ 08625-0360.

Upcoming CMMNJ events: PhillyNORML Fundraiser at the Kung Fu Necktie, 1/20/11 at 8:30 PM, $10 at the door; Stone Pony, Asbury Park, 4-day music event with the Bouncing Souls, Feb. 9 – 12. Volunteers needed at 6PM each night. CMMNJ web site revamp in progress for $1000--donations needed to offset costs. ASA f/u conf. call re: Stakeholder’s Mtng, or new ASA event? CMMNJ has a meeting scheduled with DCA Director Calcagni re: rescheduling marijuana in NJ.

Treasury report: Checking: $5,385; PayPal: $3,247. Tax-deductible donations to CMMNJ, a 501(c)(3) public charity, may be made through Paypal on our web site, or send a check made out to “CMMNJ” to the address below. Get a free t-shirt for a donation above $15—specify size.

The next CMMNJ meeting will be Tues., 2/8/11, at the Lawrence Library Room #1 from 7PM to 9PM. For info, contact: Ken Wolski, RN, MPA, 219 Woodside Ave., Trenton, NJ 08618
(609) 394-2137 ohamkrw@aol.com www.cmmnj.org info@cmmnj.org

Monday, January 17, 2011

Comment on and Critique of the revised DHSS Medicinal Marijuana Program Rules, N.J.A.C. 8:64-1.1 et. seq.

In enacting regulations to implement a statute, an executive agency is obligated to adhere to both the specific statutory terms and the clear legislative intent. An executive agency is not authorized or empowered to effectively rewrite the statute and substitute its judgment for that of the legislature. A comprehensive review of the regulations the New Jersey Department of Health and Senior Services (DHSS) has proposed to implement the Compassionate Use Act (N.J. S. A. 24:6I-1 et seq., hereinafter, The Act) overwhelmingly demonstrates that the Regulations are a clear attempt to subvert the statute and carry out not the legislative intent but the wishes of a Governor who openly opposes the statute. This is evident throughout these Regulations (hereinafter “Reg”).

On the matter of patient registration, the Reg. violates not only the Statute but also its own definition section. The Reg. defines a “qualifying patient” as one who has been provided with a physician’s certification. In Sec. 2.2 however, the Reg. mandates for a qualified patient to register, the treating physician must now register and obtain a certification number. This is an additional requirement that contradicts both the statutory and regulatory definitions of “qualified patients”.

The Act is devoid of language even suggesting that a physician must register; and certainly contains not a hint that this should be a precondition for a patient to register. In fact, in Section (hereinafter “S”) 6I-5, the Act states that to provide a certification, “a physician shall be licensed and in good standing to practice in the State.” Although the Act contains an entire section on the physician’s instructions (S 6I-10), it nowhere mentions any need for a physician to register with the DHSS. There is a compelling reason the Act does not. As Act S6I-2c acknowledges, marijuana is illegal under federal law. The Legislature is well aware that physicians depend on staying within federal law to retain the right to write prescriptions for many commonly used drugs. As the legislature understood, it is not wise to force physicians to be listed as “marijuana doctors” and face scrutiny by the federal Drug Enforcement Administration. In the absence of any statutory authority, the Department simply invents an unnecessary and dangerous registration requirement. As the statute recognizes and DHSS is well aware, the federal government does not accept medical marijuana. Without any legitimate reason, the Reg. forces physicians to accept an unnecessary and serious risk by registering. This requirement is clearly intended by DHSS to dissuade physicians from issuing certifications. Notably, it is also contrary to the entire legislative intent that we not force physicians to become “marijuana doctors” as clarified by the definition of “physician” in S6I-3. Thus does the DHSS’ misguided Reg compel the very thing the Act seeks to avoid.

In S 6I-4a(4) the Act requires that to register, as to the physician, the patient need only provide “the name, address and telephone number of the patient’s physician”. Contrary to the statute, the DHSS Reg. creates the unauthorized burden that a patient’s registration now depends on a physician’s prior registration as well as an equally absurd and unauthorized prior Alternative Treatment Center (ATC) registry. As will be discussed below when critiquing the completely unrealistic and virtually impossible conditions for an ATC to register, by deviating from the intelligent statutory construct of beginning with a patient registry, the Reg. makes it more difficult for ATCs to garner local approval, which in turn, prevents patients from registering.

In Sec. 2.2 the Reg compounds the burden for a patient to register by also requiring, contrary to the Act, that the patient provide “The name, address and telephone number of the alternative treatment center with which the applicant would register”. The Reg. distorts beyond all reason the Act’s requirement (S 6I-4a) for a “registry of qualified patients” based on the physician certification. S6I-4b of the Act provides as a sole criterion for issuing a registration card that the DHSS verify “the information contained in the application or renewal form submitted pursuant to this section.” The Reg improperly changes the Act’s requirement of a physician certification to one that must be from a physician who has registered with DHSS. It thereafter imposes the additional unauthorized and illogical precondition that a patient’s registration is dependent on the existence of an ATC. Thus, in Sec.2.2, the proposed Reg. manages to impose ultra vires conditions that stand the entire concept of a “patient registry” on its head.

The statute is quite direct: a qualified patient can register and receive an identification card. The DHSS’ deliberate complication of this simple concept is either gross incompetence or a deliberate attempt to undermine patient access to medical marijuana.

S 6I-3 in the Act requires a qualifying patient to be a New Jersey resident.
While no one disputes the obligation to document residency, Sec. 2.2(a)6 of the Reg. imposes conditions that many patients will not be able to meet. Many patients desperately needing medical marijuana do not hold a driver’s license and reference to government-issued identification is of limited use to most patients, as is a utility bill issued in their name. Here again, the Department fails to acknowledge that the Act is intended to benefit many sufferers who are “out of the mainstream.” Quite often these patients are those lacking insurance or whose assets and income are minimal. Rather than acknowledging the obligation to benefit such individuals and showing the same creativity it does in inventing unnecessary burdens, the Department’s Regs simply demonstrate an appalling lack of compassion for those suffering. Why, for example, do the Regs. fail to allow the use of medical bills issued to the patient or a simple affidavit of residency to name two obvious methods. The same deficiency applies to the registration of primary caregivers in Sec 2.3(a)5.

The Reg fails to adopt the statutory recognition that primary caregivers should also be treated with compassion. The Act in S 6I-4a(2) specifically permits the use of a sliding fee scale. Despite this invitation to compassion, the Reg. Sec.2.1 (f) imposes a $200 fee unless the caregiver meets one of the conditions in Sec 2.1[c] 1 which basically requires a showing of poverty or disability. While this may be effective for patients, why should a caregiver-one who is already a volunteer and who should be applauded for their selfless act of humanity-be forced to pay $200 for the “privilege” of volunteering. Notably, this fee has nothing to do with payment for any criminal background costs, which are billed as a separate obligation. All the fee represents is the bureaucratic cost for a simple application review. If there is to be any fee, compassion and recognition of the nature of the typical caregiver situation demands that the fee for a non-charging caregiver should be in the $25 range with the caregiver able to apply for elimination upon the showing of economic distress.

The need to certify “good standing” could easily be a part of the patient certification signed by the physician. Instead, the DHSS proposes burdensome regulations regarding the specifics of a registration. One cannot imagine the administration allowing such unnecessary regulations in any other context other than to interfere with the provision of medical marijuana as authorized by the Act.

In addition to being burdensome and unnecessary, one can add “violative of patient confidentiality” to this regulatory scheme. Sec. 2.5(a) 6 in the Reg. requires the physician to submit, “the patient’s diagnosis.” The Act avoids at every point any requirement for either the patient or the physician to disclose the debilitating medical condition that qualifies the patient to use marijuana. Thus the Act sets forth a carefully worded definition of the certification as a statement attesting to a physician’s authorization for a patient to apply for registration. S6I-5 of the Act references a “certification which meets the requirements of this act.” Nowhere does the statute require disclosure of the patient’s medical condition, only that the treating physician certify that it is within the statutory criteria for allowing medical marijuana.

The true tenor of the Reg. is abundantly apparent from Sec 2.5 (a) 9 that demands 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 Act stands in direct contradiction of this unwarranted and absurd 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” (S 6I-2a)

Thus, the Act not only fails to support the outright regulatory lie in Sec. 2.5(a)9, it directly contradicts the DHSS’ disingenuous assertion. Obviously, the Department’s heavy–handed, ideologically motivated interference with the physician-patient relationship demonstrates an intention to neither comply with the statute’s clear intent nor to be truthful. Otherwise, it would counsel physicians to inform their patients as follows:

"You should be aware that, in recorded human history, there has never been a single fatality from the use of marijuana. It is impossible to “overdose” on marijuana and there is not one emergency room report of any such occurrence. If marijuana does not help with your debilitating condition, at least you can rely on the fact that it will do you no harm. You will notice little side effect of any consequence, unlike virtually every single other medicine routinely used, including aspirin. If there is any side effect at all it will in all likelihood be benign and even pleasurable. If your condition should require regular use of marijuana, studies have shown that there is the same risk of addiction to marijuana as to coffee. However, considering the severity of your condition, a caffeine-like addiction is of no consequence."

Anyone reading the DHSS Regs or listening to its positions will realize that the DHSS would no more acknowledge the above as the truth-which it is--than it would pass Regs intended to adhere to the Act’s goal of providing usable marijuana to those in desperate need. Anyone conversant with the political battle over medical marijuana is aware that Reg Sec. 2.5 (a) is simply an ideological opposition statement contradicted by 5 years of testimony that formed the basis for the legislative action.

Inasmuch as the DHSS cannot dispute the facts, it simply ignores them and substitutes political wishes aimed at dissuading recommendations for marijuana. The fact that this is also contrary to specific legislation is of no concern to the administration. Notably, the type of admonition required by the DHSS for marijuana is not contained in approvals to use any other legally available drugs--including highly addictive and dangerous narcotics. The legislature justifiably relied on the fact that one reason physicians are subject to rigorous training and licensure requirements is so there is no reason to have their judgment overseen by bureaucrats in Trenton who have no knowledge of the patient’s diagnosis or treatment. The Act clearly leaves the decision-making to the doctor, and so must the DHSS.

In Sec 2.5(b) the Reg. requires a physician treating a minor to obtain approval from both a pediatrician and a psychiatrist. As with Sec 2.5(a) this is directly contradicted by S6I-5b in the Act, which simply requires that the treating physician obtain written approval from the minor’s parent or legal guardian. Once again, the Department deliberately places a roadblock in the delivery of medical marijuana and insults the treating physician, in whom the statute places trust. If for example, the minor’s treating physician is an oncologist, he or she would have to seek the approval for use from a physician who treats children but not cancer.

It would be remiss in highlighting all the DHSS’s contradictions to fail to also draw attention to the fact that it completely ignores the statutory admonition in S 6I-2e of the Act that the law is to: “…protect from arrest, prosecution, property forfeiture, and criminal and other penalties, those patients who use marijuana to alleviate suffering from debilitating medical conditions, as well as their physicians, primary caregivers, and those who are authorized to produce marijuana for medical purposes.” In some 110 pages of its Regs, the DHSS has not one provision of its own effectuating this crucial legislative intent. The Department cannot muster one phrase or even show it gave even a passing thought in its some 110 pages of excruciating detail on micro-management and dissuasion from use that indicates it had any concern for the legislative intent. For example, there is not even a mention of any protection for a patient from being fired from work for marijuana use not having any adverse affect on job performance. In light of the extensive attention to every detail in other matters, the omission of anything related in any way to the protection of patients, caregivers, ATC operators or physicians is indicative of a deliberate failure to comply with legislative intent.

The sole reference in the Act to the role of the parent, guardian or legal custodian of a patient who is a minor is in S6I-5b which requires that such person consent in writing to the minor’s medical use of marijuana. Sec 2.2(f)1 in the Reg requires that such person hold a registry card “however, no additional fee shall apply.” First, there is no registration as a caregiver required by the Act, and hence no need for such person to supply all the personal information required of registrants. Second, it fails to eliminate the ambiguity created by Reg Sec.2.3 requirements for a caregiver registrant. In dealing with these Regs one simply cannot trust that subsequent DHSS processing procedures will not demand that parents and other guardians submit to criminal background checks-even if free of charge. If there is to be a registration card for those in a parental or parental-type relationship, the Regs must be required to specify that the provisions relating to other caregivers do not apply to those in such a relationship. Given the overall nature of these Regs, one simply cannot trust DHSS not to needlessly burden parents.

Sec 3.4 (c) demands that registry cards be surrendered when any information changes or when a new ATC is designated. Until a new registry card is issued (for which the department had an unlimited time), the patient is denied necessary medication. Once again, there is no such proscription for any other drug, including narcotics. In contrast, S6I- 4 e (1) of the Act simply requires notification of a change within 10 days of its occurrence “or the registry identification card shall be deemed null and void”. It does not require that the card be surrendered before a new one is issued but clearly intends that the original card remain valid. In contrast to the compassion shown in the law, the DHSS ensures that the patient be deprived of marijuana while the bureaucracy processes information and sees fit to issue a new card. This is despite the fact that under S 6I-3 of the Act, the patient remains a “qualifying patient” and there is no basis to change that status because of a change in a patient’s address or ATC.

The department could easily have provided that the patient shall be issued a new card within a certain period and until such time could receive medication under the existing card. But it deliberately does not. Unfortunately, here, as everywhere else in these appalling, ultra vires Regulations, the department’s automatic default is to “punish the patient”. In reality, rather than treating persons whose doctors have recommended that they use marijuana as the patients they are, the DHSS wrote Regs treating them as criminals.

Section 4.1 (a) of the Reg. is another provision that lays a deliberate trap for patients, caregivers, physicians and ATCs. It stands in direct opposition to the Act, which states, “A patient who has been issued a registry identification card shall notify the department of any change in the patient’s name, address, or physician or change in status of the patient’s debilitating condition…” (S 6-I 4e (1) and (2) requires the same notification for primary caregivers. The DHSS distorts this straightforward notification in its Sec.4.1(a) of the Reg., which states:

"Each qualifying patient, primary caregiver or parent, guardian, custodian of a qualifying patient who is a minor, or physician shall notify the Department of any change in the qualifying patient’s name, address, alternative treatment center, physician, and/or change in status of the patient’s debilitating medical condition, within 10 days of such change.”

Should any one of the persons enumerated fail to provide this absurd, unnecessary triple redundant notice, DHSS Reg. Sec. 4.1(e) demands a severe penalty by providing it “shall result in the Department deeming the registration of the registrant to be null and void.” To the DHSS it matters not that the patient has informed it of the changes in accordance with express statutory language. If the caregiver, a parent or the physician similarly fails to provide the exact same information already in the DHSS’ possession, the patient is removed from the program and deprived of medication. Although Reg Secs 3.3(a) and 4.1(c) more closely track the Act as to notification, choosing between these inconsistent requirements is entirely, and frighteningly for all registrants, within the DHSS’ prerogative.

There is no other way to view this other than as a deliberate distortion of a straightforward, plainly worded statutory requirement for the registered person--and that person alone--to notify the department of a change in their status. The Department tortures simple notification into a demand that everyone connected to the patient (by using “each” as the crucial introductory term) notify the department of any change by a patient. Taken alone, this is simply an unfortunately worded notification provision. However, in consideration of the numerous regulatory flaws and requirements constituting the outright rejection of statutory language and intent, that is clearly not the case.

Rather, throughout these Regs there is evidence of a deliberate effort to allow the department to punish not only the patient, but also all those involved in any way with the patient’s care. Consistent with the department’s hostility to the program one can expect that, for example, should the treating physician not also provide the third confirming notification of an address change-the patient loses his registration, the caregiver his, the parent/caregiver theirs and the physician his. Again, if the regulations were not replete with such hostile wording and statutory violations, one could hope for fair administration. Under these regulations, that is not a reasonable expectation.

In reality, the DHSS is not concerned with receipt of information or it would not demand triple or quadruple notification. There is not even anything remotely similar to this regulatory provision relating to the delivery of any other legal drug, including narcotics. The obvious reason for such draconian treatment is that the Department is committed to treating marijuana as an illegal substance rather than what it is; namely, a statutorily authorized drug. It thus strains in every section for ways to deny patients access by every means possible. Reg Sec. 4.1 (e) allows DHSS to penalize everyone at once for something that is not their fault for information not even in their possession, even when the department is aware of the information.

Sec 4.3(a)2 of the DHSS Regs. which requires that the ATC provide the DHSS with the “debilitating medical conditions of qualified patients” encourages a violation of S 6I-4g in the Act which provides that the patient’s application or receipt of a registry card “does not constitute a waiver of the qualifying patient’s patient-physician privilege.” There is no reason for the patient to be required to disclose the condition to the ATC.

Additionally, the Act provides in S6I-12b that the DHSS reports to the Governor and Legislator “…shall not contain any identifying information of patients, caregivers or physicians”. Considering the level of distrust of the DHSS justified by these Regs, there can be no latitude allowed for fair administration. If the DHSS requires knowledge of the specific conditions for which treatment is used, it can request the information from physicians in a way that is not linked to specific patients. Certainly, there can be no requirement that the patient disclose a privileged matter to the ATC just as no one has to tell his or her pharmacist of the condition for which medication has been prescribed.

In Sec. 4.3(a) 5 of its Regs, the DHSS requires the ATCs to provide a “summary of patient surveys and evaluation of services.” This is a model of ambiguity. For what are the ATCs to survey the patients? Does the section refer to services rendered to the patient by the ATC? In any event this section is an attempt to pass off onto the ATC the obligation S6I-12c of the Act placed on the DHSS. If there is any surveying of patients related to the effectiveness of the program, the legislature places the responsibility on DHSS and not the ATCs. Such obligations are not within the statutory definition of an ATC in Section 6I-3 of the law, which are “…to provide registered qualifying patients with usable marijuana and related paraphernalia in accordance with the provisions of this act.”

In keeping with the statutory theme of compassion, in S 6I-3 the Act provides that a debilitating medical condition shall mean, in addition to those conditions previously determined by the legislature “(5) any other medical condition or its treatment that is approved by the department by regulation.” Unlike the time limits in S 6I-12 for an initial one-year program report with two-year reports thereafter, the Act understandably places no such limit on establishing new conditions for which medical marijuana can be used to benefit those suffering debilitating conditions.

Perhaps there is no greater deliberate cruelty on the part of the DHSS than its response to this legislative direction to aid those suffering than Sec.5.1 of the DHSS Regs. With callous disregard to any notion of compassion, the DHSS determines that:

“The Commissioner shall take no action concerning the acceptance of petitions to approve other medical conditions or the treatment thereof as debilitating medical conditions pursuant to (b) below, before completing at least two annual reports required pursuant to N.J.A.C. 8:64-4.2”

It compounds this cruel delay by providing in Sec. 5.1(b) that it shall only do so in one review cycle each year. Unfortunately, the Department cannot declare a moratorium on suffering while it ponders taking action to provide relief. There is no excuse whatsoever for this delay and it contradicts the legislative goal of expanding access to people suffering. However, as stated in Sec.5.1(a), the DHSS feels no compunction to even consider offering relief to those suffering for AT LEAST FOUR YEARS once it deigns to start the program. This is despite already having garnered for itself an extension of nine months to prepare what should be basic regulations--such as a patient registry. Ultimately, the Department has proposed Regs so violative of the statute and legislative intention that it may take many more months to repair them to comply with the statutory intent. In reality, it provides itself with an open-ended invitation to never consider adding any conditions.

It is not hyperbole to state that people will not only suffer incalculably during the department’s self-imposed, unwarranted and unauthorized four-plus-year moratorium on providing any hope of relief. Many patients will actually die in pain waiting for relief-for no reason other than DHSS feel like waiting for four years before even considering their plight. It is apparent that the DHSS bureaucrats are simply incapable of understanding the plight of patients--and they do not care to even try. Unfortunately, in reality, innocent people who had nothing to do with this cruel delay will do the suffering. In this matter, the DHSS Regs demonstrates a cruel disdain of compassion unsuitable to an enlightened society and directly contrary to the sentiments expressed in the Compassionate Use Act it is required to serve. Such callousness in the face of evident suffering is truly a disgrace for a Department supposedly devoted to “health,” especially in our democracy that formed a government “for the people.” One expects that by “people” we should expect to include those suffering serious medical conditions for which marijuana can provide much needed relief.

As if the unwarranted delay were not enough, to ensure that few, if any conditions are ever added, Sec. 5.2(b) stacks the panel with physicians none of whom are required to support medical marijuana. The reality is that too often the “ranking” establishment-type physicians the DHSS intends to appoint to the panel are the very ones with the greatest allegiance to the existing prescription drug establishment. The very same interest group that opposes medical marijuana as a direct threat to its profit. All that is required for one to be appointed is “expertise in pain and symptom management”. There is not one place on the panel for anyone who researches medical marijuana or advocates for its use. It is not an unwarranted expectation that the hostility the DHSS has shown through its Regs to the medical marijuana program will be reflected in the persons the DHSS Commissioner appoints to the review panel. Patients should not rest their hopes on unbiased evaluations from those serving the establishment and profiting from the status quo.

As a final insurance for endless delay, Sec. 5.3(b) provides for the DHSS Commissioner to make a determination whether to accept or deny the petition to add a
condition but absolutely no objective standards or time frame whatsoever in which to do so. There us no requirement to state a reason, only to make the conclusory statement that the petition is “frivolous.” Basic fairness requires that the process be de-politicized by having the petition submitted directly to the review panel and a specific basis provided for denial. It should be up to the panel to review evidence and not a Commissioner easily swayed by political pressure, as these regulations demonstrate, to employ unfettered discretion.

To further facilitate an easy denial, Reg Sec. 5.4 (a) allows the Commissioner to determine that a petition relates to a “substantially similar” condition, which the Commissioner previously denied. As with most of the decisions allocated to the Commissioner, this provides no standard to measure what is “substantially similar”-a concept by no means simple when dealing with medial maladies. For example, what if the subsequent petition relates to a condition that shares four of seven symptoms-is that “substantial” even though there are others that differ. Should one person suffer because another failed to get relief?

Additionally. the Commissioner may deny a subsequent petition unless “new scientific research supporting the request is brought forward.” This is unnecessarily prejudicial and in effect punishes subsequent petitioners for inadequate petitions submitted previously. For example, if a previous petitioner for a condition was unaware of extant gold-standard favorable scientific findings, a subsequent petition could be denied because they are not “new.” The Reg thus applies a standard applicable to a litigant in a legal appeal. It is an entirely unsuitable standard for different patients petitioning for relief and works an unjust and cruel effect. As stated throughout this critique, if this provision were an anomaly, one might expect fair evaluation. However, when viewed within the context of Regs overwhelmingly hostility to the statute’s authorization for medical marijuana, one is compelled to anticipate prejudicial implementation and interpretation.

Once the Commissioner decides to refer the matter to the review panel, it has 60 days under Sec. 5.3(d) to issue an initial recommendation, the section provides for another 120 days of subsequent processing. The panel’s recommendation is posted for a 60 day public comment, with those comments sent to the review panel. To ensure that no actual constructive additions are made and to ensure that any modification results in an entire year delay, Sec 5.3(e) provides:

“If, based on a review of the comments, the panel determines substantive changes should be made to its initial recommendation, the Commissioner shall deny the petition and the Department shall provide the petitioner with a copy of the initial recommendation and an explanation of the substantive changes and the petitioner may resubmit the petition to the Department at any time.” (The “at any time” arguably means not until the next yearly cycle in accordance with Sec. 5.1b)

The absurdity of this requirement is evident. If, for example, the panel initially found marijuana not to be beneficial for a condition but the public submissions convinced it to change its position (a clear substantive change), the result is NOT a favorable outcome but incredibly results in the Commissioner DENYING the petition. The prejudicial assumption underlying this provision is transparent. The DHSS assumes that, should a panel have the audacity to actually recommend marijuana and anyone through public comment can cause even the slightest change restricting the use, denial would be in order.

Clearly, the DHSS cannot even conceive that a panel would reverse itself and recommend marijuana after the public comment. Hence the bizarrely cruel and completely absurd result dictated by the Regs that the panel’s recommendation for the authorization of marijuana for a condition results in DENYING the petition for that very use! The inherently ridiculous regulatory approval scheme established by the DHSS in which up is down and right is left--and left out--is more suitable for a theater of the absurd. It is certainly not acceptable from a State agency charged with implementing a serious statutory goal of alleviating suffering.

If the panel should make no changes to its recommendations, Sec 5.3 (e) gives the Commissioner another 60 days to make a final determination. Thus, the Regulations generously give the Commissioner another two full months to “mull things over” for a simple recommendation. This is a period equal to the entire time allowed the panel to gather evidence and write a recommendation and follows another 60-day period of public comment. The Regulations absurdly suppose that during this 120 day period the Commissioner has not even considered the merits and thus needs another 60 days after all the evidence has been submitted.

This total SIX-MONTH delay to alleviate suffering–each minute of which people are actually suffering--is unwarranted and cruel. Simple humanity demands that the Commissioner make a recommendation within a far shorter period, such as within seven days. There is no need for another 60 days to be added to the process--other than a delay for delay’s sake. When it comes to the alleviation of suffering, one can expect some measure of attentiveness from a Commissioner supposedly dedicated to public health. This petition-approval provision is yet another damning piece of evidence that the DHSS has no intention of acting in good faith to fulfill the legislative intent to ensure compassionate use.

Lest one think there is a reasonable chance for supporters to demonstrate the efficacy of medical marijuana for a condition, Sec 5.3 (a)4 of the Regs states that before a petition can even be accepted, the petitioner must provide information on:

“The availability of conventional medical therapies other than those that cause suffering to alleviate suffering caused by the condition and/or the treatment thereof.”

Sec. 5.3(a)5 requires the petition to contain information on whether there is general acceptance in the medical community and other experts to support that medical marijuana “alleviates suffering.” This fails to acknowledge the fundamental fact that the entire field is evolving and completely foreign to many in the official medical community. Rather than simply and logically requiring reliable evidence of the efficacy and cost effectiveness of medical marijuana, the DHSS defaults to whether the establishment already supports it-–although in many cases doing so is directly contrary to their personal profit. The DHSS Regs ensure that it is a simple matter for the Commissioner to deny a petition for ailments not already acknowledged by the establishment to benefit from medical marijuana.
The Law realizes that there is a practical need for private entities to provide medical marijuana to patients. S 6I-7 of the Act states: “The department shall accept applications from entities for permits to operate as alternative treatment centers…” and “The department shall seek to ensure the availability of a sufficient number of alternative treatment centers throughout the state, pursuant to need, and including two each in the northern, central, and southern regions of the State.” As with virtually every other matter dealt with in the Act, the Regs address this obligation by re-writing it to suit the DHSS’ concept of what it believes the Act’s intent should have been.

Sec. 6.1(a) of the DHSS Reg. provides:

“The Department may periodically request applications for the entities which seek authority to apply for a permit to operate an alternative treatment center.”

The department’s interpretation of the statutorily mandated “shall accept” is “when the department feels like requesting.” Rather than an open application process understandably required by the statute, the DHSS deliberately restricts applications. To make this abundantly clear, Reg. Sec. 6.1(d) states the department “shall not consider an application that is submitted after the due date specified in, or that is not submitted in response to, a published notice of request for applications.” One cannot imagine how more directly violative of the Act the DHSS could make its Regs.

DHSS Reg 6.2 provides for a selection committee to evaluate ATC applications but includes no information as to the committee’s members or qualifications. The selection process in that section contains a litany of requirements with no basis in the statute but which clearly support the administration’s announced desire that the delivery should be through hospitals. Thus, the ATC must have, “Documented involvement of a New Jersey acute care general hospital” in the ATC’s organization, as well as “community support and participation.” Naturally, an ATC applicant is left to guess what form of “documented” involvement will be acceptable to the DHSS.

This intrusion into a private business organization is unprecedented and not required of pharmacies dispensing narcotics. If the legislature had determined this was a necessity, it could easily have so provided in the Act. Perhaps the height of business interference absurdity is in Sec. 10.1(a) 2 that demands that an ATC sell marijuana “…without volume discounts.” This is a completely unwarranted intrusion into business judgment and one defies the administration to justify this here or in any other private business.

The community participation requirement is, in addition to being unduly vague and apparently incapable of definition (in almost seven full pages devoted to definitions, the DHSS Regs do not care to attempt to define what either “community support” or “community participation” means). By preventing patients from registering until after an ATC is registered, the DHSS denies ATC’s the very basis for gaining the community support it demands that the ATC prove. If, as the Act clearly intends in S6I-4, the patients are the first to be registered, there would be an opportunity for an ATC to generate local support based on a documented local need. Equally crucial to a business enterprise, it would have a reliable basis on which to judge the potential market demand. The DHSS deliberately denied them this opportunity by constructing a backwards registration process.

Consistent with the DHSS’ overall lack of any urgency when anyone but itself can benefit, Sec 6.4 of the Regs provides for absolutely no time frame in which the DHSS shall review and issue a notice of decision on an ATC application. The department must first “convene” the selection committee and, if other provisions on approvals are relevant, there will be a lengthy period in which the Commissioner can consider the committee’s recommendations.

In its demands on the ATC applicant, the DHSS demonstrates its complete incompetence regarding business operations. Sec 7.1(b) 2ii requires an ATC to list the “names, addresses, and dates of birth of the proposed alternative treatment center’s employees, principal officers, owners and board members, including service on any other ATC board.” One must recall that this is for an entity that is merely submitting an application to be permitted to operate. To expect that the ATC hire employees prior to approval is beyond na├»ve. But the DHSS Regs are consistent in the rejection of logic as to business operations. This is also evident from the requirement in Sec. 9.3(a) 9 that the ATC disclose, “The standards and procedures by which the ATC determines the price it charges for usable marijuana and a record of the prices charged.” A record of prices may be necessary but an ATC method of price determination is of no legitimate concern to DHSS--or to the State.

Sec 7.1(b)2 vi requires the ATC to have a “medical advisory board.” Again, this is for an entity the Act provides is simply to provide usable medical marijuana. The purpose is not apparent from the Regs and is thus an arbitrary requirement intended to impose another roadblock to reasonable approval. Before an ATC is even approved or operating the ATC must, under Sec. 7.1(b)vii, show that it has complied with an inspection and audit of its ATC. Since there can be no marijuana present or even being grown, what is there to inspect? One would expect that the handling of marijuana would be of paramount concern. The Reg proceeds to require the physical address of the ATC as well as, “Written verification of the approval of the community or governing body of the municipality in which the alternative treatment center is or will be located.” Again, this begs the question of what constitutes “community” approval and how can the DHSS expect an ATC to have an address when it has no approval to operate as an ATC?

Reg Sec. 7.1(b)2 xi not only requires compliance with local codes but specifies that it include “…the distance to the closest school, church, temple or other places used exclusively for religious worship, or a playground, park, child day care facility from the alternative treatment center.” S6I-8 of the Act forbids such acts as the smoking marijuana on school grounds or public transportation. Having cognizance of local land use controls, it is for good reason that the Act makes no mention of these absurdly paranoid restrictions relative to the ATC’s location. Notably, pharmacies providing narcotics have no such restrictions. Because the DHSS Regs specify no acceptable distance, the applicant is left to wonder whether meeting a local requirement will satisfy DHSS.

Such restrictions are of considerable concern when one considers that Sec 7.1(b)2 xiii requires a showing that the exterior appearance and site of the ATC shows “…compatibility with commercial structures already constructed or under construction within the immediate neighborhood.” Sec 12.1 restricts ATC signage to “black text on a white background on external signage…” Thus, the DHSS feels free to ignore local control by substituting its judgment for the local approval authority. It is entirely possible that a municipality may wish signs to be in color, lighted or even composed of light fixtures. It is a mystery why DHSS does not simply leave the entire matter as set forth in sub par. xii, which is for the ATC to show compliance with local requirements. There are a fatal number of rejections of local land use control in the DHSS Regs. Even the location of the requirements is bizarre. Thus, in the midst of pages of details regarding ATC security, suddenly Sec. 9.7(b)13 states, “Provide on-site parking.” In addition to having at best a tenuous connection to security interests, this is yet another disregard for local land use approval authority.

In ATC physical requirements, the Regs are internally inconsistent as well as violative of local control. Sec 12.1 of the Regs specifies the exact nature of the ATC external signage including that it, “shall not be illuminated at any time.” Sec. 12.1(c) allows external identification of the building “by the permitted name.” Whatever that means it is irrelevant since this is entirely a matter for local control. As to lighting, in Sec. 9.7(b)8, the Reg states that the ATC must: “Keep the outside areas of the premises and its perimeter well lighted.” Thus. under one provision, the ATC cannot have any lighting on its signage but must have the entire perimeter lighted. Considering that the ATC identification sign will be on the outside, this is a blatant internal conflict as well as the DHSS’ standard contempt for local land use authority.

Essentially, the DHSS Regs require that those seeking to operate an ATC spend perhaps hundreds of thousands of dollars in engineering, attorney and other expert fees obtaining local municipal land use approval as well as an equally significant sum on the actual physical property, with absolutely no hint from DHSS whether its ATC application will be accepted. Certainly the statute gives no hint of supporting this absurdly backwards processing. Moreover, it requires ATCs to choose between satisfying local land approval or conflicting DHSS land use standards. Fortunately other administrative entities operate more responsibly and logically. If, for example, the DMV operated as does the DHSS, it would require that, before one could determine eligibility for a vehicle registration, he must purchase a vehicle meeting a long list of specifications, garage and have guaranteed pre-paid arrangements for the care, repair, insurance of the vehicle and only thereafter be informed whether the person would be approved to actually register it. Simply put, the entire DHSS ATC review process is exactly backwards. No sane business or regulatory agency operates in this manner--requiring a regulated entity to commit huge resources prior to knowing whether it would even qualify for regulatory approval.

If the DHSS were serious about meeting the statutory obligation to ensure that there are a sufficient number of ATCs as expressly set forth in S6I-7a of the Act, it would have a far different application process. First it would be open, with precise requirements clearly disclosed. Second, it would be grounded in reality and mindful of the ultimate objective of having sufficient ATCs to provide usable marijuana for patients across the State. Apparently it never occurred to DHSS to issue a conditional approval based on meeting standards referenced in the ATC application. This would allow potential ATC operators to prepare a plan and know whether it meets DHSS approval before committing the enormous sums of money necessary to effectuate the plan. It must he remembered that without adequate ATCs, there is no legal way for patients to obtain medical marijuana. Perversely, under the DHSS system, without ATCs there is no way for patients to even register.

As to fees, Reg Sec 6.5 requires a $20,000 fee for even non-profit ATCs and even if reasonably related to an initial approval, Sec. 7.10 requires the same fee for a simple renewal. A change of location requires $10,000 and there is a $20,000 charge for an ownership transfer. This is despite the fact that Reg Sec 7.5 provides that an ATC permit is “immediately null and void” if ownership changes-or if it relocates-even though there is a $10,000 fee for relocation which appears contradictory if the permit is void as a result of the change. The DHSS Regs unnecessarily confuse a transfer with a new registration.

Reg Sec. 9.2 (a) prohibits the consumption of either marijuana or alcohol “on, or in the vicinity of, the premises…” and 9.2 (b) prohibits the “Consumption of food and/or beverages, by qualifying patients and primary caregivers on the premises of an ATC…” Reg Sec 9.2(c ) also forbids ATC from selling food, beverages, alcohol or tobacco on site for no apparent reason and contrary to the concept of local control, which is clearly unknown to the DHSS. In addition, it ignores the role of other State agencies with control over alcohol and tobacco.

As to marijuana use, S6I-8b of the Act contains no such prohibition against consumption on the ATC premises- and for good reason. What more suitable location for marijuana use than the actual dispensary? It’s as if patrons at pharmacies were forbidden to take their medication in the pharmacy, or patrons of bars to drink there. It may very well be that patients have no other suitable place to administer it. Does the DHSS demand that it be done only at home? In the presence of one’s children!

Both the marijuana and alcohol prohibitions are unconstitutionally vague (“vicinity of”) as well as violative of police powers. The eating ban is both cruel and bizarre as well as finding no support whatsoever in the Act. Exactly what is the DHSS’ concern that a patient be deprived of the right to eat an energy bar or drink water, or eat or drink anything else while on site? If it has one, one suspects that it is so embarrassingly unwarranted it wishes to keep it a secret. Thus, it fails to state it anywhere in its 110 pages of Regs. Certainly it has not neglected to do so in the interests of brevity. The DHSS so far overreaches legitimate concerns it frequently enters the world of paranoid absurdity.

While ATC security is a concern, Sec. 9.7(b)1i requiring an “Immediate automatic or electronic notification to alert State or local police agencies…” is not only unrealistic and not required for pharmacies with narcotics but an unnecessary and overly expensive requirement. It fails to consider that the ATC may have on site security guards or private security notification. In this requirement, DHSS treats medical marijuana as if it were unknown to the larger community with the only source being the ATC. In reality, marijuana is widely available--to adults and minors alike. The prospect that there will be a significant risk of break-ins of a very secure facility for a product readily available “on the street” is simply devoid of reality and merely an excuse to further unreasonably burden an ATC. Section 9.7 is replete with security requirements that are more than adequate making electronic connections unnecessary.

Sec. 9.7 (b) 12 requires the ATC to, “Consistently and systematically prevent loitering” by those who are not ATC registrants. Unless the DHSS wishes to confer on an ATC the power to see into the future--to “prevent” rather than address it once it occurs--as well as the police powers to act, the ATC has no such power or authority. The fact that the DHSS Reg cannot even suggest what it is that the ATC must do to “prevent” loitering is evidence that it is an unduly vague requirement. Although Sec 9.7 provides extensive specific security requirements, Sec 10.1 (regarding plant cultivation) in (a) 5 requires compliance with N.J.A.C. 8:21-3A. 8 and 9 dealing with facility security. Considering the internal conflicts in the DHSS medical marijuana regulations, it would not be unexpected to discover conflicts between the two regulations. In general, the DHSS seeks to re-invent the security wheel for medical marijuana and apparently considers security for narcotics-dispensing facilities insufficient.

Although prohibiting well-accepted and commonly used methods of marijuana consumption in foods, the Regs in Sec 10.3(b) inconsistently and surprisingly allows the “production of marijuana lozenges or topical formulations.” At the informal ATC comment meeting, several people with expertise expressed surprise at the lozenge method of treatment. In fact it is basically unknown by those with extensive experience dealing with medical marijuana. Thus, the DHSS endorses a virtually unknown delivery system but rejects outright well know and commonly used ones such as in baked foods or salad dressings. This is unconscionable and more evidence of the DHSS’ callous hostility to marijuana patients. Moreover, according to the DHSS spokesperson they expect, without any supporting evidence and contrary to the testimony of experts, that patients will instinctively know or easily be able to learn how to prepare foods using marijuana. People with expertise testified to the DHSS that food preparation is complex and the DHSS expectation is an unreasonable one. However, to preserve its objection to marijuana being dispensed in consumables, the DHSS rejects the fact that a level of specific skill is required to yield a product that will be of use to the patient.

In Sec. 10.7(c) of its Regs, the DHSS redefines marijuana as that having a THC content “that shall not exceed ten percent.” This is notable for the fact that it is directly contrary to the statutory definition contained in N.J.S.A. 24:21-2 that is the one required by S6I-3 of the Act. The Act did not impose any THC limit for sound scientific reasons. One major one is the well-known fact (but not to DHSS) that plants simply do not produce THC uniformly--even within the same plant. The other is that varying levels of THC are required to treat different conditions-another fact of which DHSS is deliberately ignorant.

It should be noted that the reason our government (at least initially) gives Departments the task of writing regulations is that they are presumed to have expertise within their areas of authority. In this case, the DHSS clearly demonstrates appalling technical incompetence and an understanding of the subject that is inferior to that of the legislature. Understandably, the legislature had the benefit of years of study and hearings on the subject while the Administration virtually admits it is operating blindly and adhering to one politician’s personal desires. Embarrassingly, DHSS appears proud that it has not only failed to seek guidance from recognized experts regarding medical marijuana but that it has rejected such offers-choosing to rely on secret sources. It appears equally proud that it consciously chooses not to study any of the successful ATC programs in other states. Judging by these Regs, the DHSS’ sources are not merely devoid of useful knowledge and lacking any experience but hostile to the entire concept of medical marijuana.

As noted above, in this area the DHSS has an alarming penchant for issuing regulatory guidance in an ad hoc manner. Thus, it informed interested parties at an informal ATC information session of its position that if any one plant in an ATC’s entire crop tested over the 10% level-the entire crop must be destroyed.

The Reg Sec 10.6(d) labeling requirement for ATCs demands that the label on marijuana be “clear and truthful in all respects and shall not be false or misleading in any particular” and in the very next clause (d1) requires a statement directly violative of that requirement. Specifically: “This product is not intended to diagnose, treat, cure or prevent any disease.” One is forced to ask if the DHSS has ever actually read S6I-2a of the Act, which 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.”

Reg Sec. 10.7 limiting the cultivation to three strains is completely unsupported by the Act, which makes clear in S6I-3 that the intent is for an ATC to provide patients with “usable” marijuana. There are many different strains of marijuana and reported research documents that there are properties unique to each and they have differing effects on various maladies. Again, the DHSS embarrassingly demonstrates its technical incompetence, or deliberate heartlessness to those patients for whom none of the three arbitrarily selected strains offers any relief.

Reg Sec 10.8 (e) provides yet another example of technical incompetence by limiting marijuana to dried forms, oral lozenges or topical formulations. As noted above, none of the extremely experienced people had ever heard of lozenge use and it is completely at odds with the DHSS ban on all other consumable forms that are widely used with beneficial results. One can only speculate whose politically connected pocket this absurd requirement will line. It is certain that it was not done for any patient’s benefit.

In Reg Sec 11.1 (a) the DHSS requires that ATCs provide policies describing plans to inform patients about a variety of “educational” matters. For basic consistency, that is the job of the DHSS and not of individual ATCs. It is incredible that, with the volume of minutiae required in other areas such as security and delivery, on education the DHSS expects each ATC to write its own. For example, each ATC is required to formulate a policy as to how it will inform each patient about the potential side effects of medical marijuana. This is something DHSS should assist an ATC with; such as by providing a handout written by a knowledgeable group, as opposed to the DHSS staff which lacks basic knowledge in the area of medical marijuana.

As expected, Reg Secs 11.1 (a) 6, 7 and 8 are written as if this is a penal statute aimed at punishing offenders. Thus, the DHSS requires that ATCs counsel patients on substance abuse, substance abuse programs and “tolerance, dependence and withdrawal”. Ridiculous requirements such as these cast serious doubt on the authors’ basic knowledge about marijuana. Initially they should be reminded that medical marijuana is being used by extremely sick people who are not concerned about “substance abuse” of a substance that is providing them with relief. Equally important, the authors are clearly ignorant of the fact that marijuana has been shown to have the addictive quality of caffeine. Facts are clearly of no concern to the DHSS. It maintains its evident denial that medical marijuana has been legalized in New Jersey as in 15 other states. Thus, DHSS continues to treat it as an illegal substance with deadly consequences and to be made only minimally available and then only under the most severe restrictions possible. It is noteworthy that there are no such warning requirements mandatory for those dispensing highly addictive, highly dangerous narcotics and other drugs.

Reg Sec 11.2 (c) forces the ATC to have patients “request approval” for the ATC to involve them in peer review clinical studies. As desirable as such studies may be, the ATCs are established by law to dispense medical marijuana-not study it. This obligation should be borne solely by the DHSS.

Reg Sec. 11.3 (b) requires that patients supply an ATC with a copy of their driver’s license-so that the ATC can make it available to the DHSS. Beyond the general absurdity, this is an unwarranted invasion of the patient’s privacy. What purpose this may have is a complete mystery since the patient’s have a registration card approved by the DHSS and the DHSS can request the license directly from the patient as it has in Sec.2.2 (a) 6 i. Notably, all the Act requires (S6I-10c) is for the patient to present the registry identification card and the physician’s written instructions to obtain his marijuana.

Reg Sec. 11.4 requires ATCs to formulate a system to document patient self-assessment of pain. Once again, in one section the DHSS remarkably manages to ignore the ATCs statutorily defined role, violate patient confidentiality, interfere with the physician–patient privilege and foist off on the ATC another obligation that should rightfully belong with the DHSS.

In its continuing treatment of medical marijuana as illegal and patients as criminals, REG Sec 11.5 (a) requires the ATC to stop dispensing marijuana if the ATC “suspects or has reason to believe that the registered patient is abusing marijuana or other substances, or unlawfully redistributing usable marijuana. (Interestingly, the patients can avail themselves of the technically correct defense that any marijuana they obtain which meets DHSS criterion is not “usable” as defined by the Act). Again the DHSS improperly imposes a duty on the ATC contrary to that specified in the Act and which exceeds its expertise. Even ignoring the unfair demand to act on a “suspicion”, how are ATC personnel to know whether use of another substance is an abuse? For example, if a patient arrived and appeared inebriated, is that a ground for the ATC to deny medical marijuana? Are ATC personnel qualified to recognize the effects of any number of prescription and non-prescription drugs, which can mimic inebriation or drug abuse? As the legislature recognized, it is not the ATC’s obligation to act as a policeman any more than it is the pharmacist’s. Query, if the DHSS is serious about these obligations, will it agree to defend, indemnify and hold the ATC harmless in the lawsuit when the ATC acts on its suspicion as required by the DHSS and denies marijuana to a bona fide patient with proper credentials? ATCs would not be advised to expect any assistance from DHSS should this occur. The only thing that is or should be of concern to an ATC is whether the patient has a valid registry card and a physician’s recommendation, the only conditions the Act requires for the patient to obtain marijuana.

Reading the DHSS restrictions and controls, one would never suspect that the substance is question concerned a simple plant used by mankind for over eight thousand years and in common use today. Rather, one is led to believe that it concerns an unknown material brought to earth by a voyager space-craft with the potential to destroy all of mankind if it fell into the wrong hands. The absurd restrictions are not difficult to understand in context however. The overwhelming weight of the evidence furnished by these regulations and the events surrounding their enactment demonstrate that the DHSS’ goal is not implementation, but rather, obstruction of the medical marijuana program.

Reg Sec 12.1 (f) continues the DHSS mission to micromanage every aspect of an ATC operation and thus it states that ATCs “shall not produce any items for sale or promotional gifts, such as T shirts or novelty items, bearing a symbol or references to marijuana.” Interestingly, the DHSS is not prohibiting sale of the items in the ATC but only their “production” by the ATC. This prohibition effectively, but unconstitutionally, prohibits the legitimate use of the ATCs logo or name on any item wherever sold since its name or logo may very well make reference to marijuana which is the legitimate business the statute authorizes it to operate.

This is yet another poorly conceived, unconstitutional and bizarre restriction on a business that is impossible to understand except as a deliberate attack on an ATC’s ability to function, as would any other legal business. It is more evidence that DHSS’ aim is not the good faith implementation of the Compassionate Use Act but adherence to the administration’s objection to the law making medical marijuana legal. It is the administration’s transparent goal to undermine the law through a mass of incredibly oppressive, unnecessary and largely pointless regulations.

With regards to testing, Reg Sec. 13.4(c)3 provides that it “may include tests for, among other things, the presence of pests, mold, mildew, heavy metals, and pesticides, and the accuracy of labeling.” Notably, there is nothing pertaining to a THC content.

Another clear indication of the DHSS true intent is that it spends much effort and paper on prohibitions, restrictions, revocations and criminal penalties. Yet, it expends not one word in its 110 pages on any patient protections in crucial areas such as discrimination in employment.

In the only portion of the Regulations (Sec 13.11) referencing the exemption from penalties merely recites one portion of the protections already granted by the law in S 6I-6 of the statute. The DHSS cannot, however, muster anywhere near the enthusiasm for protections to patients, caregivers or ATCs as it can for such things as delivery protocols, the color or lighting of signs or confusing requirements.

Basically, the DHSS Regulations constitute a wholesale violation of the statutory instruction to the Commissioner in S 6I-16 of the Act to “promulgate rules and regulations to effectuate the purposes of this act…” What these regulations do is impose numerous demands not imposed by the law, (e.g., physician and parent registration, excessive and illegal limits on ATC operations as well as improper impositions of duties and interference with local land use laws). These Regs create a system designed to delay implementation of the Act and dissuade patients, physicians and ATC operators from participating.

The Regulations provide ample evidence of the DHSS’ misguided and devoid of reality zeal to protect the public from a non- existent threat. In DHSS’ distorted view, the Compassionate Use Act is “Reefer Madness.” Thus, its regulations are intended at every point to prevent the infliction of the “demon marijuana” on a vulnerable and unsuspecting public. In this completely misguided mission, DHSS ignores or rejects not only the Compassionate Use Act, but the overwhelming public support for medical marijuana as demonstrated in a recent poll relied on by the legislature documenting public support at well over 80% for medical marijuana.

It is obvious that, absent some significant and compelling impetus, the people of this State cannot rely on DHSS to craft reasonable regulations to ensure safe and adequate access to medical marijuana. In its misguided efforts all DHSS has done is ensure that patients will be driven to the illegal drug market. This is exactly opposite to the basic goal of the law. Patients requiring effective marijuana, to which they are entitled under the Act, simply cannot expect to obtain it under these DHSS Regs. Thus, they must again choose between continued suffering or the commission of a crime to alleviate their suffering.

Thursday, January 13, 2011

SCR 140: SENATE CONCURRENT RESOLUTION No. 140; Board of Medical Examiners Rules; Op Ed comment from CMMNJ

SENATE CONCURRENT RESOLUTION No. 140

STATE OF NEW JERSEY

214th LEGISLATURE

INTRODUCED DECEMBER 20, 2010


Sponsored by:

Senator NICHOLAS P. SCUTARI

District 22 (Middlesex, Somerset and Union)

Senator JIM WHELAN

District 2 (Atlantic)

SYNOPSIS

Determines that Board of Medical Examiners proposed medicinal marijuana program rules are inconsistent with legislative intent.

CURRENT VERSION OF TEXT

As introduced.


A Concurrent Resolution concerning legislative review of State Board of Medical Examiners proposed rules to implement the “New Jersey Compassionate Use Medical Marijuana Act.”

Whereas, Pursuant to Article V, Section IV, paragraph 6 of the Constitution of the State of New Jersey, the Legislature may review any rule or regulation adopted or proposed by an administrative agency to determine if the rule or regulation is consistent with the intent of the Legislature as expressed in the language of the statute which the rule or regulation is intended to implement; and

Whereas, In 2010, the Legislature enacted the “New Jersey Compassionate Use Medical Marijuana Act,” P.L.2009, c.307 (C.24:6I-1 et al.), as amended by P.L.2010, c.36 to extend the effective date of the act from July 1, 2010 to October 1, 2010; and

Whereas, The Legislature expressed in the act its findings that modern medical research has discovered beneficial uses for marijuana in treating or alleviating pain and other symptoms associated with certain debilitating medical conditions, that compassion dictates that a distinction be made between medical and non-medical uses of marijuana, and that patients who use marijuana to alleviate suffering from debilitating medical conditions and their physicians should be protected from arrest, prosecution, property forfeiture, and criminal and other penalties; and

Whereas, Although the act has many strict limitations on the use of marijuana, a patient clearly is permitted to use up to two ounces of marijuana per month if a physician with whom the patient has a bona fide relationship certifies that he has conducted a comprehensive medical history and physical examination and determines that the patient qualifies to receive marijuana; and

Whereas, On November 15, 2010, the State Board of Medical Examiners (BME), in the Division of Consumer Affairs in the Department of Law and Public Safety, proposed rules to implement the “New Jersey Compassionate Use Medical Marijuana Act,” which proposed rules were published in the New Jersey Register (N.J.A.C. 13:35-7A et seq., PRN 2010-289); and

Whereas, The BME proposed rules, at N.J.A.C.13:35-7A.5(c)3, would require physicians to periodically attempt to stop a sick or dying patient’s medical use of marijuana, decrease the quantity authorized, or try other drugs or treatment modalities, even though no such requirement exists in the act; and

Whereas, Such a requirement would clearly add to the burden and suffering of patients and runs counter to the intent to alleviate the suffering of sick and dying patients; and

Whereas, The act permits minors to use medical marijuana as long as the minor’s custodial parent, guardian, or person who has legal custody of the minor consents in writing that the minor patient has permission to use marijuana and that the parent, guardian, or person
who has legal custody will control the acquisition and possession of the medical marijuana and any related paraphernalia from the alternative treatment center; and

Whereas, Despite the fact that no such requirement exists in the act, the BME proposed rules, at N.J.A.C.13:35-7A.4(c) would require that a physician, who already has the requisite bona fide physician-patient relationship with a minor patient, must also obtain written confirmation from a pediatrician if the minor’s physician is not a pediatrician and, in all cases, from a psychiatrist, that the minor patient is likely to receive therapeutic or palliative benefits from the medical use of marijuana; such a requirement would clearly add to the burden and suffering of minor patients; and

Whereas, The rules proposed by the BME are not consistent with the “New Jersey Compassionate Use Medical Marijuana Act” and would undermine the Legislature’s intent to provide for a medical marijuana program that provides relief to suffering patients; now, therefore,

Be It Resolved by the Senate of the State of New Jersey (the General Assembly concurring):

1. The Legislature declares that the proposed rules to implement the “New Jersey Compassionate Use Medical Marijuana Act,” published by the State Board of Medical Examiners, in the Division of Consumer Affairs in the Department of Law and Public Safety, on November 15, 2010 in the New Jersey Register are not consistent with the intent of the Legislature as expressed in the language of “New Jersey Compassionate Use Medical Marijuana Act,” P.L.2009, c.307 (C.24:6I-1 et al.), as amended by P.L.2010, c.36.

2. Pursuant to Article V, Section IV, paragraph 6 of the Constitution of the State of New Jersey, the State Board of Medical Examiners, in the Division of Consumer Affairs in the Department of Law and Public Safety, shall have 30 days following transmittal of this resolution to amend or withdraw the proposed regulations or the Legislature may, by passage of another concurrent resolution, exercise its authority under the Constitution to invalidate the regulations in whole or in part.

3. The Secretary of the Senate and the Clerk of the General Assembly shall transmit a duly authenticated copy of this concurrent resolution to the Governor, the Attorney General, the Director of the Division of Consumer Affairs, and the Executive Director of the State Board of Medical Examiners.


STATEMENT

This concurrent resolution embodies the finding of the Legislature that the rules proposed by the State Board of Medical Examiners (BME), in the Division of Consumer Affairs in the Department of Law and Public Safety, to implement the “New Jersey Compassionate Use Medical Marijuana Act,” P.L.2009, c.307 (C.24:6I-1 et al.), as amended by P.L.2010, c.36, are not consistent with the intent of the Legislature as expressed in the language of the act.

The proposed rules would require physicians to periodically attempt to stop a patient’s medical use of marijuana or decrease the quantity authorized, or try other drugs or treatment modalities. This requirement appears nowhere in the act, and is contrary to the Legislature’s intent to provide relief for suffering patients.

In addition, the proposed rules would require that a minor’s physician, who already has the bona fide physician-patient relationship with the minor required under the act, seek additional confirmation from a pediatrician (if the minor’s physician is not a pediatrician) and, in all cases, from a psychiatrist, that the minor patient is likely to receive therapeutic or palliative benefits from the medical use of marijuana.

These two requirements proposed by the BME clearly impose additional burdens on patients and their physicians, and contradict the Legislature’s intent as expressed in the “New Jersey Compassionate Use Medical Marijuana Act.”

The resolution provides that the Executive Director of the BME will have 30 days from the date of transmittal of this resolution to amend or withdraw the proposed rules and regulations, or the Legislature may, by passage of another concurrent resolution, exercise its authority under the Constitution to invalidate the rules and regulations in whole or in part.


Marijuana therapy interruption is cruel; BME Regs

by Ken Wolski on Saturday, December 11, 2010 at 12:10am

The Times of Trenton Op-Ed

Wednesday, November 24, 2010

SPECIAL TO THE TIMES

The proposal by the state Board of Medical Examiners (BME) to make New Jersey doctors try to wean their patients off of medical marijuana every three months is simply another example of how the crafting of medical marijuana regulations is being driven by fear, ignorance and hostility ("Christie: Tighten rules on medical marijuana," Nov. 16).

The New Jersey Compassionate Use Medical Marijuana Act is already the most restrictive of all such laws in the nation. The qualifying conditions are severely limited and include any patient with a diagnosis of less than 12 months to live. Now the BME is insisting that doctors periodically stop a medication that brings relief to a dying patient "in an effort to reduce the potential for abuse or dependence." It is absurd and cruel. Drug dependence is simply not an issue for a patient with only months to live.

Another qualifying condition is seizures, including epilepsy. After all the routine anticonvulsant medications have been proven ineffective in controlling a patient's seizures, a patient may be greatly relieved to find that his seizures have finally been brought under control by marijuana. This was true for Tim DaGiau, a young man from Clifton who presented written testimony to the New Jersey Assembly Health Committee in 2009. Mr. DaGiau also endured five painful and expensive surgical procedures on his brain in unsuccessful attempts to control his seizures, which were finally brought under control by daily doses of marijuana. Mr. DaGiau had to leave his family and his home and take up residence in Colorado, where he could legally obtain marijuana. His performance in college greatly improved once he stopped having frequent seizures. Far from impeding his productivity, his daily marijuana use enabled him to be successful. Now, patients like Mr. DaGiau, back in New Jersey, will periodically have to stop the medical use of marijuana, decrease the quantity that was authorized, or try other drugs or treatments so the doctors can watch them have seizures again. The rule is an outrage.

Or consider another qualifying condition -- glaucoma. Glaucoma is a leading cause of blindness in the U.S. because, for many patients, traditional medication is ineffective in controlling the pressure inside the eyes that causes it. Marijuana can relieve this intraocular pressure. Marijuana must be considered a life-long maintenance treatment in these cases. The alternative is permanent blindness. These patients should never be subject to periodic treatment interruptions.

Or consider multiple sclerosis (MS), one of a few neurological conditions that qualify for marijuana therapy under the New Jersey law. The expert opinion paper of the National Clinical Advisory Board of the National Multiple Sclerosis Society, "Recommendations Regarding the Use of Cannabis in Multiple Sclerosis" (2009), affirmed that marijuana could control the symptoms of MS, especially pain and muscle spasms. The experts acknowledged that traditional therapies were often ineffective in relieving the symptoms. But the MS experts went further and acknowledged that marijuana had neuroprotective qualities and could possibly delay the progression of the dread disease. With the new rule, if an MS patient is experiencing symptom control under marijuana therapy, the physician is then required to reduce or stop the dosage periodically until the patient's symptoms increase. During the therapy interruption, the patient will also lose the unseen neuroprotective benefits of marijuana and the course of the progressive disease will be hastened. It is no wonder that certain medical practices are looked upon, through the hindsight of history, to be horrors. The proposed new rule will be one of them.

Nor is dependence a major concern with marijuana. 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, seizures, death); heroin (flu-like symptoms); or nicotine (intense craving). The addiction potential for marijuana is about equivalent to that of caffeine. You might be irritable and have some sleep disturbance if someone takes your daily cup of coffee away, but it is not something that a physician needs to stop every three months to see if you are addicted to it.

The New Jersey BME clearly lacks education about marijuana and experience with medical marijuana therapy. Physicians, or others who are experts in this specialized area, should be the ones proposing the new rules.

Ken Wolski, RN, MPA, is executive director of the Coalition for Medical Marijuana-New Jersey Inc. (cmmnj.org).

http://www.nj.com/opinion/times/oped/index.ssf?%2Fbase%2Fnews-1%2F129058113795481.xml&coll=5

3 of 4 DOCUMENTS

NEW JERSEY REGISTER

Copyright © 2010 by the New Jersey Office of Administrative Law

VOLUME 42, ISSUE 22

ISSUE DATE: NOVEMBER 15, 2010

RULE PROPOSALS

LAW AND PUBLIC SAFETY

DIVISION OF CONSUMER AFFAIRS

BOARD OF MEDICAL EXAMINERS

42 N.J.R. 2728(a)

Proposed New Rules: N.J.A.C. 13:35-7A

Click here to view Interested Persons Statement

Compassionate Use Medical Marijuana

Authorized By: William Roeder, Executive Director, Board of Medical Examiners.

Authority: N.J.S.A. 24:6I-1 et seq. (P.L. 2009, c. 307).

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2010-289.

Submit comments by January 14, 2011 to:

William Roeder, Executive Director

Board of Medical Examiners

140 East Front Street, 2nd Floor

P.O. Box 183

Trenton, NJ 08625

The agency proposal follows:

Summary

The State Board of Medical Examiners (the Board) is proposing new rules at N.J.A.C. 13:35-7A that set forth

Page 1

requirements for physicians who wish to authorize the medical use of marijuana for their patients under the New Jersey

Compassionate Use Medical Marijuana Act (the Act), N.J.S.A. 24:6I-1 et seq. The Act authorizes the use of marijuana

to treat or alleviate pain or other symptoms associated with certain specifically identified debilitating medical

conditions. Under the Act, a physician must certify that a patient suffers from a debilitating medical condition and,

therefore, is qualified to be registered with the Department of Health and Senior Services (the Department) to obtain and

use marijuana for medicinal purposes. In addition, a patient's physician must provide written instructions for the

patient's medical use of marijuana, which are to be transmitted to an alternative treatment center authorized by the

Department to dispense marijuana. The Department has proposed rules, published elsewhere in this edition of the New

Jersey Register, that establish the process through which qualifying patients or their primary caregivers, and patients'

physicians may register with the Department in order to avail themselves of the benefits of the Act.

Proposed new N.J.A.C. 13:35-7A.1 sets forth the purpose and scope of the new subchapter, and states that the new

rules will apply to physicians who wish to provide certifications and written instructions for patients to obtain marijuana

for medicinal use under the Board's and the Department of Health and Senior Services' rules.

Proposed new N.J.A.C. 13:35-7A.2 sets forth the definitions of relevant terms used throughout the subchapter.

Specifically, the new rule defines the terms "bona fide physician-patient relationship," "certification," "debilitating

medical condition" and "medical use of marijuana," consistent with the definition of those terms in N.J.S.A. 24:6I-3 of

the Act. Under the Act, "bona fide physician-patient relationship" is defined as a relationship in which the physician has

ongoing responsibility for the assessment, care and treatment of a patient's debilitating medical condition. The Board

has further defined the term "ongoing responsibility" to mean that the physician-patient relationship has existed for at

least one year, or that the physician has seen or assessed the patient for the debilitating medical condition on at

[page=2729] least four visits, or that the physician has assumed responsibility for providing management and care of the

patient's debilitating medical condition after conducting a comprehensive medical history and physical examination,

including a personal review of the patient's medical record maintained by other treating physicians. The Board believes

that the proposed language is consistent with the legislative intent, reflected in the statutory definition of "physician"

under the Act, that a physician's treatment of the patient must include more than authorizing the patient to use medical

marijuana or consulting solely for that purpose.

In addition, the Board notes that under the Act, seizure disorders, including epilepsy, intractable skeletal muscular

spasticity or glaucoma are deemed "debilitating medical conditions" if they are resistant to conventional medical

therapy. The Board believes that a patient with such conditions should be able to use medical marijuana if he or she is

unable to tolerate conventional therapy. Accordingly, under the rule definition, such conditions are deemed debilitating

medical conditions if they are resistant to conventional medical therapy, or if the patient is unable to tolerate such

therapy. The Board believes that this modification is reasonable and consistent with the statutory intent of the Act to

permit persons who suffer from these conditions, who do not benefit from the use of conventional medical therapies, to

avail themselves of the benefits associated with the medical use of marijuana. The Board notes that the recordkeeping

requirements outlined in the new rules, and discussed below, will require the patient's medical record to reflect a course

of treatment that substantiates the patient's experience with conventional medical therapies.

Under proposed new N.J.A.C. 13:35-7A.3, a physician may provide patient certifications and written instructions

for marijuana use only if the physician has an active license in good standing with the Board, possesses an active

controlled dangerous substances (CDS) registration issued by the Division of Consumer Affairs, and has a bona fide

physician-patient relationship with the patient. Although not required under the Act, the Board believes that requiring

physicians to possess an active CDS registration in order to participate in the distribution of marijuana for medical

purposes is reasonable and consistent with the classification of marijuana as a Schedule I medication under the New

Jersey Controlled Dangerous Substances Act, N.J.S.A. 24:21-2. This requirement, coupled with the requirement to have

a bona fide physician-patient relationship - which by definition imposes on the physician the on-going responsibility for

the assessment, care and treatment of the patient's debilitating medical condition - will help to ensure the health, safety

and welfare of patients who choose to use marijuana for medicinal purposes.

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42 N.J.R. 2728(a)

Under proposed new N.J.A.C. 13:35-7A.4, prior to issuing a certification for the medical use of marijuana, a

physician must have conducted a comprehensive medical history and physical examination of the patient to determine

whether the patient suffers from a debilitating medical condition. The certification must attest to the physician's

authorization for the patient to be registered with the Department, and must include specific information about the

physician, the patient and, if applicable, the patient's caregiver. Subsection (c) imposes additional requirements upon a

physician who wishes to provide a certification to a patient who is a minor. Prior to issuing a certification, the physician

must obtain written confirmation from a physician trained in the care of pediatric patients and from a psychiatrist, which

establishes, following review of the minor's medical records or an examination, that the patient is likely to receive

therapeutic or palliative benefits from the medical use of marijuana to treat or alleviate symptoms associated with his or

her debilitating medical condition. If the certifying physician is trained in the care of pediatric patients, he or she will

only be required to obtain written confirmation from a psychiatrist. In addition, the new rule requires the certifying

physician to explain the potential risks and benefits of the medical use of marijuana to the minor patient and to his or

her parent or guardian. This explanation must be documented in the minor patient's medical record.

Proposed new N.J.A.C. 13:35-7A.5 establishes requirements for issuing written instructions. The instructions must

include specific information about the physician, the patient and, if applicable, the patient's caregiver, and must also

include the name of the alternative treatment center the patient has been authorized to go to by the Department and the

quantity of marijuana to be dispensed. Consistent with the requirements of the Act, a patient may not receive more than

two ounces of marijuana in a 30-day period.

Subsections (c) through (f) impose requirements for patient reassessment and record documentation that are

consistent with requirements under existing rule N.J.A.C. 13:35-7.6, imposed by the Board on physicians who treat

patients with other controlled dangerous drugs listed in other Schedules. Specifically, subsection (c) of the rule requires

a physician who authorizes a patient's use of marijuana to review, at least once every three months, the patient's course

of treatment, any new information about the patient's debilitating medical condition and the patient's progress toward

treatment objectives. A physician must also remain alert to problems associated with physical and psychological

dependence on marijuana, and periodically make reasonable efforts, unless clinically contraindicated, to stop the

medical use of marijuana, decrease the quantity authorized, or try other drugs or treatments in an effort to reduce the

potential for abuse or dependence.

N.J.A.C. 13:35-7A.5(d) provides that if treatment objectives are not being met, the physician must assess the

appropriateness of continued treatment with marijuana or undertake a trial of other drugs or treatments and must

consider referring the patient for independent evaluation or treatment in order to achieve treatment objectives.

Under subsection (e), a physician must remain alert to the possibility that marijuana may be misused or diverted; it

requires a physician issuing written instructions for a patient with a history of substance abuse to exercise extra care by

way of monitoring, documentation and possible consultation with addiction medicine specialists. A physician should

also consider the use of an agreement with the patient outlining the medical use of marijuana and the consequences for

misuse.

N.J.A.C. 13:35-7A.5(f) requires physicians to keep accurate and complete records that include the patient's medical

history and the results of physical examinations. The record must also include the diagnosis of the debilitating medical

condition, including the patient's symptoms and their severity, as well as other evaluations and consultations, treatment

plan objectives, evidence of informed consent, any agreements with the patient and periodic reviews. In obtaining the

patient's informed consent, the physician must advise the patient about the lack of scientific consensus for the medical

use of marijuana, its sedative properties and the risks for addiction.

N.J.A.C. 13:35-7A.5(g) prohibits a physician from authorizing a patient to receive more than two ounces of

marijuana in a 30-day period, consistent with the statutory requirements of N.J.S.A. 24:6I-10a. Under subsection (h), a

physician may, consistent with the requirements of N.J.S.A. 24:6I-10b, issue multiple written instructions at one time

that authorize the patient to receive a total of up to a 90-day supply of marijuana. Each separate set of instructions must

Page 3

42 N.J.R. 2728(a)

be issued for the treatment of the patient's documented debilitating medical condition. In addition, the separate set of

instructions must indicate the earliest date on which the alternative treatment center may dispense the marijuana, except

for the first dispensation if it is to be filled immediately. Moreover, the physician must determine that the issuance of

multiple instructions for the patient does not create an undue risk of diversion or abuse.

N.J.A.C. 13:35-7A.5(i) requires the physician to keep a copy of the patient's, or if applicable, the caregiver's

registry identification card, in the patient's medical record once the card is obtained from the Department of Health and

Senior Services. Under N.J.A.C. 13:35-7A.5(j), if the physician determines that the patient's underlying debilitating

medical condition no longer exists or that the patient's continued use of marijuana is no longer appropriate, the

physician must notify the Department of his or her findings, so that the Department may take appropriate action.

Proposed new N.J.A.C. 13:35-7A.6 requires participating physicians to comply with all requests for information

from the Division of Consumer Affairs concerning certifications and written instructions they have issued. Under

N.J.S.A. 45:1-45.1, the Division is required to collect certain information from both physicians and alternative treatment

centers. Consistent with this authority, the Division has proposed rules for collecting this information, published

elsewhere in this edition of the New Jersey Register. N.J.A.C. 13:35-7A.6 provides that failure on the part of a

physician to comply with the Division's rules requiring [page=2730] transmittal of the requested information may

subject the physician to disciplinary action pursuant to N.J.S.A. 45:1-21 et seq.

The Board also notes that it is contemplating requiring physicians who wish to provide certifications and written

instructions for their patients under the new rules to complete a certain number of continuing medical education credits

in courses relevant to the treatment of patients with medical marijuana. The Board intends to study this issue further,

and in consultation with the Department of Health and Senior Services, will seek to identify specific subject areas or

particular courses that the Board believes will be beneficial for participating physicians and the patients they treat.

The Board has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted

from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Board believes that the proposed new rules will have a positive impact upon physicians who choose to

authorize the medical use of marijuana for their patients and upon those patients who seek to avail themselves of its use,

by clarifying a physician's initial and on-going obligations with respect to patient care. The Board believes that the

proposed new rules will help to ensure that patients choosing to utilize marijuana for medicinal purposes will do so only

under the care of a physician with whom the patient has an on-going physician-patient relationship.

Economic Impact

The Board does not anticipate that the proposed new rules will impose any economic burden on physicians.

Although physicians choosing to authorize patient use of marijuana for medicinal purposes may incur some

administrative costs associated with conducting medical histories and physical examinations, and with monitoring,

reassessing and documenting patient use of marijuana, such costs are no higher than the customary administrative costs

physicians incur to treat and monitor patients with whom they have an on-going physician-patient relationship.

Federal Standards Statement

A Federal standards analysis is not required because the proposed new rules are being implemented pursuant to the

New Jersey Compassionate Use Medical Marijuana Act, N.J.S.A. 24:6I-1 et seq. Under existing Federal law, the

manufacture, possession, sale or distribution of marijuana is prohibited. See 21 U.S.C. §§841 et seq. States, however,

are not required to enforce Federal law. In enacting the New Jersey Compassionate Use Medical Marijuana Act, the

New Jersey Legislature found that compliance with the Act does not put the State of New Jersey in violation of Federal

Page 4

42 N.J.R. 2728(a)

law. See N.J.S.A. 24:6I-2.

Jobs Impact

The Board does not believe that the proposed new rules will result in the creation or the loss of jobs in the State.

Agriculture Industry Impact

The Board does not believe that the proposed new rules will have any impact on the agriculture industry of the

State.

Regulatory Flexibility Analysis

Currently, the Board licenses approximately 30,000 physicians who possess a valid CDS registration. If these

physicians are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16

et seq., then the following analysis applies.

The proposed new rules will impose various reporting, recordkeeping and compliance requirements upon

physicians who choose to authorize the medical use of marijuana for their patients. These requirements are detailed in

the Summary above.

No additional professional services will be needed to comply with the proposed new rules. The Board does not

anticipate that physicians choosing to authorize patient use of medical marijuana will incur any increased costs as a

result of the proposed new rules.

The Board believes that the proposed new rules must be uniformly applied to all authorized physicians in order to

effectuate the purposes of the Compassionate Use Medical Marijuana Act. Therefore, no differing compliance

requirements for authorized physicians are provided based upon the size of the business.

Smart Growth Impact

The Board does not believe that the proposed new rules will have any impact upon the achievement of smart

growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The proposed new rules will have an insignificant impact on affordable housing in New Jersey and there is an

extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the

proposed new rules concern physician authorization for patient use of marijuana.

Smart Growth Development Impact

The proposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that

the rules would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the

State Development and Redevelopment Plan in New Jersey because the proposed new rules concern physician

authorization for patient use of marijuana.

Full text of the proposed new rules follows:

SUBCHAPTER 7A. COMPASSIONATE USE MEDICAL MARIJUANA

13:35-7A.1 Purpose and scope

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42 N.J.R. 2728(a)

(a) The rules in this subchapter implement certain provisions of the New Jersey Compassionate Use Medical Marijuana

Act, P.L. 2009, c. 307.

(b) The rules in this subchapter shall apply to physicians who provide certifications and written instructions for patients

seeking marijuana for medical use pursuant to rules adopted by the Board and by the Department of Health and Senior

Services.

13:35-7A.2 Definitions

The following words and terms when used in this subchapter shall have the following meanings, unless the context

indicates otherwise.

"Bona fide physician-patient relationship" means a relationship in which the physician has ongoing responsibility for

the assessment, care and treatment of a patient's debilitating medical condition, consistent with the requirements of

N.J.A.C. 13:35-7A.5. For purposes of this definition, "ongoing responsibility" means:

1. The physician-patient relationship has existed for at least one year;

2. The physician has seen and/or assessed the patient for the debilitating medical condition on at least four visits; or

3. The physician assumes responsibility for providing management and care of the patient's debilitating medical

condition after conducting a comprehensive medical history and physical examination, including a personal review of

the patient's medical record maintained by other treating physicians reflecting the patient's reaction and response to

conventional medical therapies.

"Certification" means a statement signed by a physician with whom a patient has a bona fide physician-patient

relationship, which attests to the physician's authorization for the patient to be registered to use marijuana.

"Debilitating medical condition" means:

1. One of the following conditions, if resistant to, or if the patient is intolerant to, conventional medical therapy: seizure

disorder, including epilepsy; intractable skeletal muscular spasticity; or glaucoma;

2. One of the following conditions, if severe or chronic pain, severe nausea or vomiting, cachexia or wasting syndrome

results from the condition or its treatment: positive status for human immunodeficiency virus, acquired immune

deficiency syndrome or cancer;

3. Amyotrophic lateral sclerosis, multiple sclerosis, terminal cancer, muscular dystrophy or inflammatory bowel

disease, including Crohn's disease;

4. Terminal illness, if the physician has determined a prognosis of less than 12 months of life; or

5. Any other medical condition or its treatment that is approved by the Department of Health and Senior Services by

rule.

"Medical use of marijuana" means the acquisition, possession, transport or use of marijuana or paraphernalia by a

qualified patient [page=2731] registered with the Department of Health and Senior Services under P.L. 2009, c. 307.

13:35-7A.3 Requirement for physician participation

Page 6

42 N.J.R. 2728(a)

(a) A physician shall provide a certification and written instructions for a patient for the medical use of marijuana only

if:

1. The physician holds an active New Jersey license in good standing issued by the Board and possesses an active

controlled dangerous substances registration issued by the Division of Consumer Affairs that is not subject to limitation;

and

2. The physician has a bona fide physician-patient relationship with the patient.

13:35-7A.4 Certification requirements

(a) Prior to issuing a certification for the medical use of marijuana, the physician shall have conducted a comprehensive

medical history and physical examination of the patient to determine whether the patient suffers from a debilitating

medical condition that qualifies the patient to receive marijuana pursuant to N.J.S.A. 24:6I-3.

(b) The certification shall be signed and dated by the physician and shall attest to the physician's authorization for the

patient to be registered with the Department of Health and Senior Services for the medical use of marijuana. If

authorized by the Department of Health and Senior Services, the certification shall be electronically transmitted to the

Department of Health and Senior Services. The certification shall include the following information:

1. Physician name, address and telephone number;

2. Physician license number and CDS registration number;

3. Patient name, address, telephone number and date of birth;

4. If applicable, caregiver name, address, telephone number and date of birth;

5. Diagnosis of debilitating medical condition; and

6. Any other information required by the Department of Health and Senior Services by rule.

(c) Prior to issuing a certification for the medical use of marijuana for a minor patient, a physician shall:

1. Obtain written confirmation from a physician trained in the care of pediatric patients and from a psychiatrist,

establishing that, in their respective professional opinions, following review of the minor patient's medical record or

examination of the minor patient, the minor patient is likely to receive therapeutic or palliative benefits from the

medical use of marijuana to treat or alleviate symptoms associated with his or her debilitating medical condition. If the

certifying physician is trained in the care of pediatric patients, he or she shall only be required to obtain written

confirmation from a psychiatrist; and

2. Explain the potential risks and benefits of the medical use of marijuana to the minor patient and to a parent, guardian

or person having legal custody of the minor patient. Such explanation shall be documented in the minor patient's

medical record.

13:35-7A.5 Written instruction requirements; reassessment; records

(a) A physician may provide written instructions for the medical use of marijuana for a qualified patient registered with

the Department of Health and Senior Services, provided the requirements in this section are satisfied. If authorized by

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42 N.J.R. 2728(a)

the Department of Health and Senior Services, the physician may provide the written instruction by electronic or other

means directly to an alternative treatment center on behalf of a registered qualifying patient.

(b) The physician's written instructions shall include the following information:

1. Physician name, address and telephone number;

2. Physician license number and CDS registration number;

3. Patient name, address, telephone number, date of birth and registry identification number;

4. If applicable, caregiver name, address, telephone number, date of birth and registry identification number;

5. Name of the permitted alternative treatment center;

6. Quantity of marijuana to be dispensed; and

7. Any other information required by the Department of Health and Senior Services by rule.

(c) A physician authorizing the medical use of marijuana shall:

1. Review, at a minimum of every three months, the course of treatment, any new information about the patient's

debilitating medical condition and the patient's progress toward treatment objectives;

2. Remain alert to problems associated with physical and psychological dependence; and

3. Periodically make reasonable efforts, unless clinically contraindicated, to stop the medical use of marijuana, decrease

the quantity authorized or try other drugs or treatment modalities in an effort to reduce the potential for abuse or the

development of physical or psychological dependence.

(d) If treatment objectives are not being met, the physician shall:

1. Assess the appropriateness of continued treatment with marijuana or undertake a trial of other drugs or treatment

modalities; and

2. Consider referring the patient for independent evaluation or treatment in order to achieve treatment objectives.

(e) The physician shall remain alert to the possibility that marijuana may be misused or diverted. A physician issuing

written instructions for a patient with a history of substance abuse shall exercise extra care by way of monitoring,

documentation and possible consultation with addiction medicine specialists, and should consider the use of an

agreement between the physician and the patient concerning the medical use of marijuana and consequences for misuse.

(f) The physician shall keep accurate and complete records that include:

1. The medical history and physical examination of the patient;

2. The diagnosis of the debilitating medical condition, including the patient's symptoms and their severity and the

patient's reaction and response to conventional medical therapies, which qualify the patient for the medical use of

marijuana;

Page 8

42 N.J.R. 2728(a)

3. Other evaluations and consultations;

4. Treatment plan objectives;

5. Evidence of informed consent. In obtaining informed consent, the physician shall advise the patient about the lack of

scientific consensus for the medical use of marijuana, its sedative properties and the risks for addiction;

6. Treatments and other drugs prescribed or provided;

7. Any agreements with the patient; and

8. Periodic reviews conducted.

(g) A physician shall not issue written instructions authorizing a patient to receive more than two ounces of marijuana in

a 30-day period.

(h) A physician may issue multiple written instructions at one time authorizing the patient to receive a total of up to a

90-day supply of marijuana, provided that the following conditions are met:

1. Each separate set of instructions is issued for the treatment of the patient's documented debilitating medical condition;

2. Each separate set of instructions indicates the earliest date on which the alternative treatment center may dispense the

marijuana, except for the first dispensation if it is to be filled immediately; and

3. The physician has determined that providing the patient with multiple instructions in this manner does not create an

undue risk of diversion or abuse.

(i) The physician shall keep a copy of the patient's, or if applicable, the caregiver's registry identification card, in the

patient's medical record.

(j) If the physician determines that the patient's underlying debilitating medical condition no longer exists or that the

patient's continued use of marijuana is no longer appropriate, the physician shall notify the Department of Health and

Senior Services of his or her findings.

13:35-7A.6 Duty to report information to the Division

(a) A physician shall comply with all requests for information from the Division of Consumer Affairs concerning the

issuance of certifications and written instructions for the medical use of marijuana as provided in N.J.A.C. 13:45A-32.

(b) Failure on the part of a physician to comply with the requirements of N.J.A.C. 13:45A-32 may subject the physician

to disciplinary action pursuant to N.J.S.A. 45:1-21 et seq.