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.

No comments:

Post a Comment