333-008-0090 Addition of Qualifying Diseases or Medical Conditions (1) For the purposes of this rule, the following definitions apply: (a) DSM means the latest published edition of Diagnostic and Statistical Manual of Mental Disorders. (b) ICD means the most recent revision of the International Classification of Diseases published by the United Nations-sponsored World Health Organization that provides codes, up to six characters long, to classify diseases and a variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease. (c) Peer-reviewed published scientific study means that a study has been cited by the Cochrane Review, the Institute of Medicine, or PubMed Central. (d) Petitioner means an individual who has filed a petition in accordance with ORS 475C.913 and this rule. (e) State Public Health Officer (SPHO) means the individual appointed by the Director of the Authority in accordance with ORS 431.045, or his or her designee. (2) The Authority shall accept a written petition from any person requesting that a particular disease or condition be included among the diseases and conditions that qualify as a debilitating medical condition under ORS 475C.777. (a) A petition may only request a single disease or condition be added as a debilitating medical condition. A separate petition must be submitted for each disease or condition proposed to be added as a debilitating medical condition. (b) A petition must be submitted by mail using a form prescribed by the Authority and must include, along with the form, the following in an electronic format (e.g. compact disc (CD) or thumb drive): (A) A specific description of the disease or condition proposed to be added and its characteristics, including the applicable ICD code or the specific diagnosis as described in the DSM; (B) A general explanation of how or why the petitioner believes marijuana would mitigate the symptoms or effects of the disease or condition that is the subject of the petition; and (C) At least one peer-reviewed published scientific study showing the efficacy in humans for use of medical marijuana for the disease or condition that is the subject of the petition. (c) A petitioner may also include with the information required to be submitted in subsection (2)(b) of this rule letters of support from physicians or other licensed health care professionals knowledgeable about the disease or condition proposed to be added, and any other information the petitioner believes the SPHO should review in considering the petition. (d) If a petitioner submits a petition to add the same or a substantially equivalent disease or condition that was the subject of a petition that was denied by the SPHO within the last five years from the date a new petition is submitted, a petitioner must submit at least one peer-reviewed published scientific study that was published since the date the SPHO denied the previous petition for the same or substantially equivalent disease or condition. (e) A petition may not contain individually identifiable health information as that is defined in ORS 433.443 unless any individual identified in relation to health information submits an Authorization for Use and Disclosure of Information on a form prescribed by the Authority. A petition that contains individually identifiable health information that is submitted without the required authorization must be returned to the petitioner as incomplete. (f) A petition that does not contain all the information required by section (2) of this rule shall be returned to the petitioner as incomplete. A petition returned as incomplete is not considered a denial for purposes of subsection (2)(d) of this rule. (3) If the petitioner has submitted a petition with all the information required in section (2) of this rule, the SPHO must: (a) Assign a petition number to the petition; (b) Notify the petitioner by certified mail that the petition has been accepted; (c) Post a notice, a copy of the petition and materials submitted by the petitioner on the Authority's website announcing that the petition has been accepted and is under consideration, and solicit information from individuals or organizations concerning experts in cannabis therapeutics and scientific studies, including but not limited to peer-reviewed published scientific studies; (d) Notify the Oregon Cannabis Commission (OCC) by electronic mail that the petition is under consideration, and request from the OCC recommendations regarding relevant experts and information pertinent to the petition; (e) Conduct an investigation that may, as the SPHO determines necessary, include: (A) Consulting with one or more experts in cannabis therapeutics and one or more experts on the disease or condition that is the subject of the petition; (B) Requesting a literature review and a summary of peer-reviewed published scientific studies related to the use of marijuana for the disease or condition that is the subject of the petition, from neutral persons knowledgeable about conducting such reviews; and (C) Gathering any other information the SPHO believes relevant to making a decision on the petition. (f) Hold a public hearing at a time and place determined by the SPHO. At the public hearing the petitioner shall have the opportunity to address the SPHO in person or by telephone. Written comments shall be accepted by the SPHO for one week following the close of the public hearing. (4) Following the investigation identified in subsection (3)(e) of this rule and the close of the public comment period specified in subsection (3)(f) of this rule, the SPHO must issue a Notice of Intent to either approve or deny the petition. (a) The SPHO must issue a Notice of Intent to Approve the petition if, based on the evidence presented to and considered by the SPHO, the SPHO finds that: (A) Marijuana is efficacious for the disease or condition that is the subject of the petition or marijuana may mitigate the symptoms or effects of the disease or condition that is the subject of the petition; and (B) Any risk of physical or mental harm from using marijuana for the disease or condition that is the subject of the petition is outweighed by the physical or mental benefit of using marijuana for that disease or condition. (b) The SPHO must issue a Notice of Intent to Deny the petition if the SPHO determines that the evidence presented to and considered by the SPHO does not meet the standards established in subsection (4)(a) of this rule. (c) The Notice of Intent must be in writing and must describe all evidence and information upon which the decision of the SPHO is based, including the identity and credentials of all experts relied upon. (d) If the Authority issues a Notice of Intent to Deny the petitioner is entitled to a contested case hearing as provided under ORS chapter 183. The petitioner has 30 days to request a hearing. (5) At a contested case hearing, the petitioner has the burden of proving the decision of the SPHO was without a reasonable basis in fact. (6) The SPHO must issue a final order within 180 days of receipt of a complete petition. (7) A petitioner may withdraw his or her petition without prejudice at any time prior to the public hearing specified in subsection (3)(f) of this rule. A petition withdrawn after the public hearing specified in subsection (3)(f) of this rule shall be deemed denied for purposes of this rule. Statutory/Other Authority: ORS 475C.913 & 475C.919 Statutes/Other Implemented: ORS 475C.913 History: PH 69-2022, minor correction filed 05/11/2022, effective 05/11/2022 PH 123-2018, minor correction filed 04/27/2018, effective 04/27/2018 PH 29-2017, amend filed 12/22/2017, effective 01/01/2018 PH 18-2012, f. 12-26-12, cert. ef. 1-1-13 PH 15-2007, f. 12-19-07, cert. ef. 1-1-08 PH 18-2005, f. 12-30-05, cert. ef. 1-1-06 OHD 6-2002, f. & cert. ef. 3-25-02 OHD 18-2001, f. & cert. ef. 8-9-01 OHD 3-1999, f. & cert. ef. 4-29-99