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OPRA - Open Public Records Act

RULE PROPOSALS
VOLUME 42, ISSUE 22
ISSUE DATE: NOVEMBER 15, 2010
Law and Public Safety
Division of Consumer Affairs
BOARD OF MEDICAL EXAMINERS

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

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 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.

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 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. ßß841 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 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

(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

(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 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;

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.

   
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