NJ DOH Rules to Add Conditions that Qualify for Marijuana Therapy

SUBCHAPTER 5. ESTABLISHMENT OF ADDITIONAL DEBILITATING MEDICAL CONDITIONS

8:64-5.1 Review cycle for accepting petitions for additional qualifying debilitating medical
condition

(a) 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.
1. The Department shall publish notice of an open period to accept petitions in the New Jersey Register.
(b) The process for review of petitions to approve other medical conditions or the treatment thereof as debilitating medical conditions pursuant to the definition at N.J.S.A. 24:6I-3 of “debilitating medical condition” at paragraph (5) shall include one review cycle each year, subject to (a) above.
(c) The beginning of each cycle shall be the first business day of the month.
(d) The Department shall accept petitions on the first business day of each cycle.
(e) The Department shall return to the petitioner a petition submitted in any month outside of the review cycle as not accepted for processing.

8:64-5.2 Panel to review petitions and make recommendations for identification and approval of additional debilitating medical conditions; membership; responsibilities

(a) The Commissioner shall appoint a review panel (panel) to make recommendations to the Commissioner regarding approval or denial of a petition submitted pursuant to this subchapter.
(b) The panel shall consist of not more than 15 health care professionals, among whom shall be:
1. The President of the Board of Medical Examiners or the President’s designee; and
2. Other physicians and non-physicians who are knowledgeable about the condition as to which the petition seeks approval;
i. Each physician appointed to the review panel shall be nationally board-certified in his or her area of specialty; and
3. At least three physicians appointed to the review panel shall have expertise in pain and symptom management.
(c) The majority of the panel shall be physicians.
(d) The Department shall convene the panel at least once per year to review petitions.
1. The panel may examine scientific and medical evidence and research pertaining to the petition, and may gather information, in person or in writing, from other parties knowledgeable about the addition of the debilitating medical conditions being considered.
2. The petitioner shall be given the opportunity to address the panel in person or by telephone.
3. The petitioner may request that his or her individual identifiable health information remain
confidential.
4. The Department shall provide staff support to the panel and other administrative support.
5. The meetings will be considered open public meetings.
(e) The panel shall make a written recommendation to the Commissioner regarding approval or denial of the addition of a qualifying debilitating medical condition.
1. A quorum of the panel shall concur with the recommendation in order to be considered a final recommendation of the panel.
i. For purposes of this subsection, a majority of the members appointed and serving on the panel constitute a quorum.

8:64-5.3 Addition of qualifying debilitating medical condition

(a) In order for the petition to be accepted for processing, the petitioner shall send a letter by
certified mail to the Medicinal Marijuana Program that contains the following information:
1. The extent to which the condition is generally accepted by the medical community and other experts as a valid, existing medical condition;
2. If one or more treatments of the condition, rather than the condition itself, are alleged to be the cause of the patient’s suffering, the extent to which the treatments causing suffering are generally accepted by the medical community and other experts as valid treatments for the condition;
3. The extent to which the condition itself and/or the treatments thereof cause severe suffering, such as severe and/or chronic pain, severe nausea and/or vomiting or otherwise severely impair the patient’s ability to carry on activities of daily living;
4. The availability of conventional medical therapies other than those that cause suffering to alleviate suffering caused by the condition and/or the treatment thereof;
5. The extent to which evidence that is generally accepted among the medical community and other experts supports a finding that the use of marijuana alleviates suffering caused by the condition and/or the treatment thereof; and
6. Letters of support from physicians or other licensed health care professionals knowledgeable about the condition.
(b) Upon review of materials submitted pursuant to (a) above, the Commissioner shall make a
final determination as to whether:
1. The petition is frivolous and, if so, to deny a petition without further review; or
2. The petition is bona fide and, if so, to accept the petition for further review.
(c) If the petition is accepted, the Department shall refer the written petition to the review panel established pursuant to N.J.A.C. 8:64-5.2.
(d) Within 60 days of the receipt of the petition, the review panel shall consider the petition in view of the factors identified in (a) above and shall issue an initial written recommendation to the Commissioner as to whether:
1. The medical condition and/or the treatment thereof is/are debilitating;
2. Marijuana is more likely than not to have the potential to be beneficial to treat or alleviate the debilitation associated with the medical condition and/or the treatment thereof; and
3. Other matters that the panel recommends that the Commissioner consider that are relevant to the approval or the denial of the petition.
(e) Upon receipt of the panel’s recommendation, the Department shall:
1. Post the review panel’s recommendations on the Department’s website for 60-day public comment period;
2. Post notice of a public meeting no fewer than 10 days prior to the public meeting; and
3. Hold a public hearing within the 60-day public comment period.
(f) After the public hearing, the Department shall forward the comments made during the public
hearing to the review panel for its consideration.
1. 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.
2. If, based on a review of the comments, the panel determines to recommend no changes to its initial recommendation, the initial recommendation shall be deemed a final recommendation and the Commissioner will make a final determination on the petition within 180 days of receipt of the petition.

8:64-5.4 Denial of a petition considered final agency action subject to judicial review

(a) If a condition in a petition is the same as, or is, as determined by the Commissioner, substantially similar to a condition of which the Commissioner has issued a previous determination denying approval as a debilitating medical condition pursuant to N.J.A.C. 8:64-5.3, the Commissioner may deny the new petition unless new scientific research supporting the
request is brought forward.
(b) A decision of the Commissioner issued pursuant to N.J.A.C. 8:64-5.3 or this section is a final agency decision, of which jurisdiction and venue for judicial review are vested in the New Jersey Superior Court, Appellate Division.