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

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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

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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

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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;

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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.

1 comment:

  1. Every healthcare provider should switch to an EMR solution. Paper based records and prescriptions are a thing of the past now and it would be best for both doctors and patients to take advantage of their features and accessibility.

    Medical Billing I Free EMR

    ReplyDelete