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RULE PROPOSALS
VOLUME 42, ISSUE 22
ISSUE DATE: NOVEMBER 15, 2010
Law and Public Safety
Division of Consumer Affairs
OFFICE OF THE DIRECTOR

Proposed New Rules: N.J.A.C. 13:45A-33

Compassionate Use Medical Marijuana

Authorized By: Thomas R. Calcagni, Acting Director, Division of Consumer Affairs.
Authority: N.J.S.A. 24:6I-1 et seq. (P.L. 2009, c. 307) and 45:1-45.1 (Section 11 of P.L. 2009, c. 307).

Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2010-288 .

Submit comments by January 14, 2011 to:

Thomas R. Calcagni, Acting Director
Division of Consumer Affairs
Director's Office
P.O. Box 45027
Newark , NJ 07101

The agency proposal follows:

Summary

The Division of Consumer Affairs (the Division) is proposing new rules at N.J.A.C. 13:45A-33 that will require physicians and alternative treatment centers that participate in the distribution of medical marijuana under the New Jersey Compassionate Use Medical Marijuana Act (the Act), P.L. 2009, c. 307, to report certain information to the Division. The Division is proposing these new rules consistent with section 11 of the Act, codified at N.J.S.A. 45:1-45.1, which requires the Division to collect information from physicians and alternative treatment centers in order to monitor the dispensation of marijuana for medical use in the State.

The Act authorizes the use of marijuana to treat or alleviate pain or other symptoms associated with certain debilitating medical conditions. Under the Act, a patient's physician must issue a certification authorizing the patient to be registered with the Department of Health and Senior Services (the Department) to obtain and use marijuana for medicinal purposes. The physician must also issue written instructions to an alternative treatment center that is permitted by the Department to dispense marijuana to the patient. The Board of Medical Examiners (the Board) has proposed rules, published elsewhere in this edition of the New Jersey Register, containing requirements for physicians who wish to authorize the use of medical marijuana for their patients. 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 caregivers, and patients' physicians may be registered with the Department in order to avail themselves of the benefits of the Act and to permit alternative treatment centers.

Proposed new N.J.A.C. 13:45A-33.1 sets forth the purpose and scope of the new rules and provides that the rules will apply to physicians and alternative treatment centers authorized to participate in the distribution of medical marijuana pursuant to rules adopted by the Board and by the Department.

Proposed new N.J.A.C. 13:45A-33.2 requires a physician who provides certifications and written instructions for a patient's use of medical marijuana to electronically transmit certain information to the Division about the physician, the patient and, if applicable, the patient's caregiver. The physician must also submit information to the Division concerning the alternative treatment center designated in the written instructions, the date the written instructions were issued, and the quantity of marijuana authorized under the written instructions. All information must be submitted to the Division by the physician within one week of his or her issuance of the written instructions for the patient.

Proposed new N.J.A.C. 13:45A-33.3 requires an alternative treatment center to electronically transmit information to the Division about the physician; the patient; the patient's caregiver, if applicable; the quantity of marijuana dispensed; the date the marijuana was dispensed; and the source of payment for the marijuana. This information must be submitted by the alternative treatment center within one week of dispensing marijuana to the patient.

Proposed new N.J.A.C. 13:45A-33.4 requires physicians and alternative treatment centers to electronically transmit the required information in a format specified by Division. If a physician or alternative treatment center cannot electronically transmit the required information, the rule permits the physician or alternative treatment center to request a waiver of the electronic submission requirements from the Division. The waiver request must be in writing and must document the reasons for the inability to electronically submit the required information. The waiver request must also specify the format the physician or alternative treatment center requests permission to use for submission of the required information.

Proposed new N.J.A.C. 13:45A-3.5 requires physicians and alternative treatment centers to transmit the required information to the Division at least once a week, on the day and at the time specified by the Division, and establishes a process for correcting omissions or errors in submitted information. The rule also requires physicians and alternative treatment centers to transmit the required information in a manner that ensures the confidentiality of patient information.

Proposed new N.J.A.C. 13:45A-33.6 provides that the Division may waive the submission requirements for physicians and alternative treatment centers imposed under the new rules if the Division is able to obtain the requested information electronically from the Department of Health and Senior Services.

The Division 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 Division believes that the proposed new rules will have a positive impact upon the citizens of New Jersey by helping to ensure the effective implementation of the Division's data collection requirements under the Compassionate Use Medical Marijuana Act.

Economic Impact

The proposed new rules may have an economic impact upon physicians and alternative treatment centers to the extent that physicians and alternative treatment centers may incur administrative costs associated with the electronic submission of information to the Division. The Division believes that such costs will vary based on the computer systems utilized by individual physicians and alternative treatment centers. The Division also believes that such costs are outweighed by the need to have the requested information submitted in a timely manner and in a uniform electronic format, so that the Division may effectively fulfill its statutory obligations under the Compassionate Use Medical Marijuana Act.

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 [page=2744] 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. Although the new rules are proposed under the authority of the New Jersey Compassionate Use Medical Marijuana Act, the Division notes that physicians and alternative treatment centers submitting information under the new rules are required to do so consistent with Federal privacy protection requirements, including the requirements imposed under the Federal Health Insurance Portability and Accountability Act of 1996.

Jobs Impact

The Division 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 Division 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 of Medical Examiners licenses approximately 30,000 physicians who possess a valid controlled dangerous substance (CDS) registration. At this time, the Department of Health and Senior Services has not permitted any alternative treatment centers. If these physicians and the alternative treatment centers that will be permitted by the Department of Health and Senior Services 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 issue certifications and written instructions for the use of marijuana for their patients, and upon the alternative treatment centers that dispense marijuana to such patients. These requirements are detailed in the Summary above.

No additional professional services will be needed to comply with the proposed new rules. Physicians and alternative treatment centers may incur administrative costs associated with electronically transmitting the required information to the Division. The Division cannot estimate the administrative costs to be borne by physicians and alternative treatment centers because these costs will vary depending on the computer system capabilities of the individual sender.

The Division believes that the proposed new rules must be uniformly applied to all authorized physicians and permitted alternative treatment centers in order to effectuate the purposes of the Compassionate Use Medical Marijuana Act. Therefore, no differing compliance requirements for authorized physicians or alternative treatment centers are provided based upon the size of the business.

Smart Growth Impact

The Division 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 the reporting of information to the Division by physicians and alternative treatment centers about the authorized 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 the reporting of information to the Division by physicians and alternative treatment centers about the authorized use of marijuana.

Full text of the proposed new rules follows:

SUBCHAPTER 33. COMPASSIONATE USE MEDICAL MARIJUANA

13:45A-33.1 Purpose and scope

(a) The rules in this subchapter implement the provisions of N.J.S.A. 45:1-45.1 (Section 11 of P.L. 2009, c. 307), which require the Division of Consumer Affairs to collect information concerning the dispensing of medical marijuana pursuant to the New Jersey Compassionate Use Medical Marijuana Act.

(b) The rules in this subchapter shall apply to physicians and alternative treatment centers authorized to participate in the distribution of medical marijuana pursuant to rules adopted by the State Board of Medical Examiners and by the Department of Health and Senior Services.

13:45A-33.2 Physician reporting requirements

(a) A physician who provides certifications and written instructions for patient use of medical marijuana shall electronically transmit the following information to the Division of Consumer Affairs within one week of issuing written instructions to a patient and/or caregiver:

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. Patient or, if applicable, caregiver registry identification number;

6. Alternative treatment center designated in the written instructions;

7. Date written instructions issued;

8. Patient diagnosis; and

9. Quantity of marijuana authorized under the written instructions.

13:45A-33.3 Alternative treatment center reporting requirements

(a) An alternative treatment center permitted by the Department of Health and Senior Services shall electronically transmit the following information to the Division of Consumer Affairs within one week of dispensing medical marijuana to a qualifying patient or caregiver:

1. Alternative treatment center permit number;

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

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

4. Physician name, address and telephone number;

5. Physician license number and CDS registration number;

6. Patient or, if applicable, caregiver registry identification number;

7. Quantity of marijuana dispensed;

8. Date dispensed; and

9. Source of payment.

13:45A-33.4 Electronic format required for the transmission of information; exemption

(a) Physicians and alternative treatment centers shall transmit the information required by N.J.A.C. 13:45A-33.2 and 33.3 electronically in a format specified by Division of Consumer Affairs (Division).

(b) In the event that a physician or alternative treatment center cannot electronically transmit the required information to the Division, the physician or alternative treatment center shall request a waiver of the electronic transmission requirements of this subchapter from the Division. The waiver request shall be in writing and shall document the reasons for the inability to electronically transmit the required information. The waiver request shall also specify the format the physician or alternative treatment center requests permission to use for submission of required information to the Division.

13:45A-33.5 Frequency requirements for transmitting information; confidentiality

(a) Physicians and alternative treatment centers shall transmit required information to the Division of Consumer Affairs (Division) at least once a week on the day and at the time specified by the Division.

(b) If a physician or alternative treatment center discovers an omission or error in the transmitted information, the physician or alternative treatment center shall immediately notify the Division and shall submit the omitted or corrected information to the Division during the next scheduled reporting period after the discovery.

[page=2745] (c) Physicians and alternative treatment centers shall transmit required information in such a manner as to ensure the confidentiality of patient information in compliance with all Federal and State laws, rules and regulations, including the Federal Health Insurance Portability and Accountability Act of 1996, PL 104-191.

13:45A-33.6 Waiver

The Division of Consumer Affairs (Division) may waive the reporting requirements for physicians and/or alternative treatment centers imposed under this subchapter if the Division is able to obtain the requested information from the Department of Health and Senior Services in an electronic format.

   
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