Haw. Code R. § 11-160-7 - Department-approved conditions; petition process

(a) Any physician, advanced practice registered nurse, or potentially qualifying patient seeking to add a medical condition to the list of debilitating medical conditions shall file a written petition with the department on forms and in a manner prescribed by the department. For purposes of this section, "potentially qualifying patient" means a person who has been diagnosed with the medical condition for which the petition is being made.

(b) The petition shall, at a minimum, contain:

(1) The specific medical condition or its treatment for which the petition is being made;

(2) An explanation stating the reasons why the medical condition or its treatment should be added to the list of qualifying debilitating medical conditions;

(3) The extent to which the medical condition is generally accepted by the medical community as a valid, existing medical condition;

(4) A description of the symptoms and other physiological or psychological effects experienced by an individual suffering from the medical condition or its treatment and the extent to which these symptoms and physiological or psychological effects are debilitating;

(5) If one or more treatments for the medical condition, rather than the condition itself, are alleged to be the cause of a person's suffering, the extent to which the treatments causing suffering are generally accepted by the medical community as valid treatments for the medical condition;

(6) The availability of conventional medical therapies other than those that cause suffering to alleviate symptoms caused by the medical condition or its treatment;

(7) The extent to which evidence supports a finding that the use of cannabis alleviates symptoms caused by the medical condition or its treatment;

(8) Any information or studies regarding any beneficial or adverse effects from the use of cannabis in patients with the medical condition; and

(9) Letters of support from physicians or other licensed health care professionals knowledgeable about the medical condition.

(c) If a medical condition in a petition has been previously considered and denied by the department, or is determined by the department to be substantially similar to a denied condition, the department may deny the petition without further review unless new scientific research supporting the request is included in the petition.

(d) The department may make a final determination that a petition is frivolous and deny the petition without further review.

(e) If the petition does not meet the requirements of this section or is denied under subsection (c) or (d), the department shall notify the petitioner that the petition does not meet the requirements of this section and give the specific reason for the determination.

(f) If the petition meets the requirements of this section, the department shall notify the petitioner that the department will conduct a public hearing to discuss the petition.

(g) At least once per calendar year, if there are pending petitions, the department shall conduct a public hearing to receive public oral or written testimony on those petitions; provided that the department shall have the discretion to establish time deadlines for the inclusion of petitions in the public hearings.

(h) At least thirty calendar days before a public hearing, the department shall publish on its website the date, time, and location of the hearing, a list of the medical conditions that the department will be considering at the public hearing, and the procedure for submitting public comments. The department shall also maintain a list of names and mailing or electronic mail addresses of persons who request notification of public hearings to consider petitions and shall transmit a copy of the notice to those persons at their last known addresses at least fifteen calendar days before a public hearing.

(i) The department in its discretion may conduct an investigation, to the extent the department deems necessary, which may include:

(1) Consulting with one or more persons knowledgeable in the medical use of cannabis and one or more experts on the medical condition that is the subject of a petition;

(2) Conducting a literature review of peer-reviewed published scientific studies related to the use of cannabis for the medical condition that is the subject of the petition; and

(3) Gathering any other information the department believes relevant to making a decision on the petition.

(j) The director shall approve, deny, or defer a petition within ninety calendar days following the public hearing at which a petition was considered. In reaching a decision on a petition, the director may consider the following;

(1) The petition;

(2) Public comments and testimony; and

(3) The department's investigation pursuant to subsection (i).

(k) The director shall:

(1) Approve the petition if in the director's discretion the evidence supporting the petition justifies adding the condition as a debilitating medical condition;

(2) Deny the petition if in the director's discretion the evidence supporting the petition does not justify adding the condition as a debilitating medical condition; or

(3) Defer consideration of the petition if additional time is needed to review the evidence.

(l) The director's written decision shall include the factors supporting the decision and shall be sent to the petitioner and posted on the department's website, subject to redaction of any information protected under chapter 92F, HRS.

(m) A decision by the department to deny a petition pursuant to subsection {c) or (d) or a decision of the director issued pursuant to subsection (j) is a final agency action.

Notes

Haw. Code R. § 11-160-7

Eff 7/18/2015 (Auth: HRS § 321-9) (Imp: HRS § 329-121) Am and comp 2/25/2019 (Imp: SLH 2017, Act 170, §2)