Regulation 5 CCR 1006-2-6
Current through Register Vol. 47, No. 11, June 10, 2024
Regulation 5 CCR 1006-2-6 - Debilitating medical conditions and the process for adding new debilitating medical conditionsA.Definitions. The definitions described here only pertain to Regulation 6. 1. Adverse effects - effects a recognized treatment is known to have that are physically or mentally harmful or undesirable to some patients undergoing the treatment.3. Recognized medical condition - a medical condition that is generally accepted by the medical community and other experts as a valid, existing medical condition, and that can be accurately diagnosed by a physician.4. Recognized treatment - a treatment of the medical condition that is generally accepted by the medical community and other experts as a valid, existing medical treatment, and is routinely used by physicians treating the proposed medical condition.B.Debilitating medical conditions. Section 14 of Article XVIII of the Colorado constitution allows for the medical use of marijuana for persons suffering from debilitating medical conditions. 1. The article specifies the following debilitating medical conditions:a. Cancer, glaucoma, positive status for Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome, or treatment for such conditions.b. A chronic or debilitating disease or medical condition, other than HIV infection, cancer, or glaucoma, or treatment for such conditions, which produces, for a specific patient, one or more of the following, and for which, in the professional opinion of the patient's physician, such condition or conditions reasonably may be alleviated by the medical use of marijuana: cachexia; severe pain; severe nausea; seizures, including those that are characteristic of epilepsy; or persistent muscle spasms, including those that are characteristic of multiple sclerosis.2. Pursuant to the Department's rulemaking authority, the article allows for the addition of debilitating medical conditions through petitions submitted by a Colorado patient or physician.C.Required medical and scientific criteria for petitions to add a debilitating medical condition. Petitions submitted to the Department for review must include the following: 1.Proposed medical condition. A description of the proposed medical condition, including symptoms and other physiological effects experienced by an individual suffering from the medical condition or receiving treatment for the medical condition, and an explanation of how these are debilitating in such a way that they cause severe suffering and impair the ability of the individual to accomplish activities of daily living. Applicable International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) or Diagnostic and Statistical Manual of Mental Disorders, 5th Revision (DSM-V) codes should be provided.2.Proposed patient population. A description of the proposed patient population, including any restrictions on patient age (e.g. 18 years of age and older only), or qualifiers on the severity or symptom profile (e.g. severe pain only) of the proposed medical condition that would apply if the petition is approved.3.Traditional scientific evidence of medical efficacy or evidence of medical benefit and biologic plausibility. a. Traditional scientific evidence of medical efficacy. Documents supporting the assertion that the use of medical marijuana has demonstrated clinical benefit for the proposed medical condition in human subjects, as demonstrated by published research detailing the outcomes of randomized controlled trials or well-designed observational studies. Greater weight will be given to such peer-reviewed documentation; or b. Evidence of medical benefit and biologic plausibility. Documents supporting the assertion that the use of medical marijuana has demonstrated medical benefit and biologic plausibility for the proposed medical condition, as demonstrated by: i. Published peer-reviewed case reports or case series describing individuals with the proposed medical condition who experienced medical benefit as a result of using marijuana (medical or otherwise), and ii. Peer-reviewed, published studies describing animal model(s) of the proposed medical condition found that treating such animals with marijuana (medical or otherwise) reduces the adverse effect of the medical condition, or iii. Peer-reviewed, published studies that describe the biological process and demonstrate marijuana (medical or otherwise) impacts this biological process in a way that could reasonably be expected to provide medical benefit for the proposed medical condition. A single study or combination of studies may be submitted to satisfy this requirement.4.Relative safety and unsatisfactory treatment options. In addition to the required information above, petitions may include evidence documenting relative safety and unsatisfactory treatment options. When petitions do not include this evidence, the Department will attempt to obtain this evidence to supplement petitions. Such evidence is necessary for the Department to approve a petition and request a Board hearing.a. Relative safety. The use of medical marijuana as a treatment for the proposed medical condition is expected to have adverse effects no worse than the adverse effects of currently recognized treatments for the condition. The following evidence will be used to compare these:i. Evidence of the adverse effects of marijuana use (medical or otherwise), other than harm associated with smoking (e.g. obstructive lung disease or lung cancer), will come from published research on the health effects of marijuana or from results of clinical trials of marijuana-related pharmaceuticals, which are as applicable to the proposed patient population as possible.ii. Evidence of recognized treatments, their effectiveness, and their adverse effects can be established by one of the following:1. One or more published comprehensive reviews of the proposed medical condition that includes recognized treatments used for the condition, their effectiveness, their potential adverse effects, and the frequency of those adverse effects.2. Reports of adverse effects from the U.S. Food and Drug Administration's MedWatch program or clinical trials for the recognized treatment.b. Unsatisfactory treatment alternatives. Recognized treatments for the proposed medical condition are not sufficient to alleviate the debilitation caused by the medical condition, or show effectiveness but have limited acceptability due to the adverse effects. i. Evidence of recognized treatments, their effectiveness and their adverse effects can be established using evidence as described in C.4.a.ii.c. If a petitioner, after making a reasonable effort is unable to submit evidence of relative safety and unsatisfactory treatment options, the petitioner may document their good faith effort to obtain this evidence.D.Department review of petitions to add debilitating medical conditions. Upon receipt of a petition that contains all of the information required in Section C, the Department shall review petitions according to the following: 1.Petitioner requirements. Petitions must be filed by a patient residing in Colorado or a physician who is authorized under these rules to recommend medical marijuana for a debilitating medical condition. The petitioner must provide their name, address, email address, and telephone number.2.Limits on proposed medical conditions. Petitions must be limited to one proposed medical condition. The proposed medical condition must be a recognized medical condition for which the condition itself and/or the treatment thereof cause severe suffering and impair the ability of the individual to accomplish activities of daily living.3.Required documentation. Petitions must include medical and scientific documentation, as described in Section C of this regulation.a. If a previous petition to add the proposed medical condition has been considered within the past 3 years, the petitioner must also provide new published, peer-reviewed evidence that was not available to the petitioner at the time of the previous petition.4.Supplemental evidence. For each petition received, the Department may conduct a search of the medical literature for relevant evidence including evidence described in Section C.3 and C.4. The Department may also contact subject matter experts with expertise in or related to the proposed medical condition, or seek input from informed members of the medical marijuana community to assist in its analysis.5.Amending a petition. The Department may find that potential benefits or harms associated with the use of marijuana (medical or otherwise) to treat the proposed medical condition vary based on the type of product, patient population, or other factors. In such cases, the Department may contact the petitioner and ask the petitioner to amend the petition. Examples of when a petition may be modified include but are not limited to: restricting the petition to a specific age group or a subset of persons with the proposed medical condition (e.g. a person 18 years of age or older with severe nausea).6.Denial of a petition. The Department shall deny a petition to add a debilitating medical condition, without requesting a rulemaking hearing by the Board, in any of the following circumstances: a. If the evidence and documentation supporting the petition is insufficient to satisfy the criteria in Section C.b. If the proposed medical condition is debilitating primarily because of a symptom or symptoms for which the medical use of marijuana is already approved according to Section B of this regulation.c. If the proposed medical condition is already approved as a debilitating condition or disabling condition.d. If the petition is incomplete. If completing the petition would require only small corrections or additions, the Department may contact the petitioner and ask for documentation necessary to make the petition complete. Once the petition is complete, the petition will be reviewed within 180 days of the petitioner resubmitting the petition. To the extent possible, the Department's determination will be made within 90 days of receipt of a complete petition.e. If a petition to add the requested medical condition has been previously considered within the last 3 years, and no new evidence has been submitted by the petitioner.f. The proposed medical condition has already been recognized by the Colorado General Assembly as a disabling medical condition, § 25-1.5-106 (a.7), C.R.S.7.Approval of a petition and request for a rulemaking hearing. If, upon review, the Department determines that: the petition is complete, and there is sufficient evidence that the anticipated benefit of the medical use of marijuana outweighs any anticipated harms associated with marijuana use (medical or otherwise) among the proposed patient population, the Department will request that the Board schedule a rulemaking hearing to review the petition to add the proposed medical condition to the list of debilitating medical conditions. As part of the request for rulemaking, the Department will provide the Board: b. The Department's recommendation as to whether the proposed medical condition should be added to the list of debilitating medical conditions based on the Department's analysis of the criteria described in Section C and the Department's analysis of whether the anticipated therapeutic benefits outweigh the anticipated harm,c. An assessment of whether the Department can monitor adverse effects of medical marijuana used to treat the proposed medical condition, andd. Such other information the Department, at its discretion, deems relevant.8.Determination timeframe. To the extent possible, the Department's determination will be made within 90 days of receipt of a petition. When issuing a determination, the Department will explain the basis for its decision.E.Board rulemaking hearing to consider a petition to add a debilitating medical condition. For petitions to add a debilitating medical condition that the Department refers to the Board for a rulemaking hearing, the Board will review the petition, any additional medical, scientific or testimonial documents identified by the Department during their review of the petition, and any additional information or documentation provided by the public, health professionals or the Department during the rulemaking hearing process. The Board is encouraged to consider whether there is sufficient evidence that the medical use of marijuana is more likely than not to provide therapeutic benefit to patients suffering from the condition, and that such anticipated benefit outweighs any anticipated harms associated with marijuana use (medical or otherwise) among the proposed patient population. The rulemaking hearing will comply with Section 24-4-103, C.R.S., and Section 25-1.5-106(4), C.R.S.F.Removal or qualification of a debilitating medical condition from the approved list of conditions. For any medical condition added to the list of debilitating medical conditions through the petition process, if additional information becomes available that would change the Department or Board's analysis, the Department may initiate a rulemaking to remove or qualify the condition. The rulemaking hearing will comply with Section 24-4-103, C.R.S., and Section 25-1.5-106(4), C.R.S.G.Final agency action. The following actions are final agency actions, subject to judicial review pursuant to § 24-4-106, C.R.S.: 1. Department denials of petitions to add a medical condition to the list of debilitating medical conditions.2. Board denials of rules proposed by the Department to add a medical condition to the list of debilitating medical conditions.3. Board action to remove or qualify a medical condition previously added to the list of debilitating medical conditions by the Board.Regulation 5 CCR 1006-2-6
37 CR 20, October 25,2014, effective 11/14/201438 CR 15, August 10, 2015, effective 9/14/201538 CR 24, December 25, 2015, effective 1/14/201641 CR 08, April 25, 2018, effective 5/15/201842 CR 08, April 10, 2019, effective 5/15/201942 CR 20, October 25, 2019, effective 11/14/201945 CR 01, January 10, 2022, effective 2/14/202245 CR 06, March 25, 2022, effective 4/14/2022