Petition to add a debilitating condition

 
Legal authority
Section 14 of Article XVIII of the Colorado Constitution (referred to herein as “Constitution”) requires the state health agency to enact rules of administration, including the manner in which the agency may consider adding debilitating medical conditions to the list of debilitating medical conditions established in the Constitution, see also Section 25-1.5-106(3)(a)(VII), C.R.S. The constitution further requires:
 
Beginning June 1, 1999, the state health agency shall accept physician or patient initiated petitions to add debilitating medical conditions to the list provided in this section and, after such hearing as the state health agency deems appropriate, shall approve or deny such petitions within one hundred eighty days of submission. The decision to approve or deny a petition shall be considered a final agency action.
 
The department, through the State Board of Health, has promulgated rules concerning the Medical Marijuana Registry (MMR). Regulation 6, which concerns debilitating medical conditions and the process for adding new debilitating medical conditions, begins on page 7.
 
How do I file a petition to add a debilitating condition?
If you would like to file a petition to add a debilitating medical condition, please submit your petition to the department via email at: cdphe.bohrequests@state.co.us. 
 
When submitting your petition, please consider the following:
  1. Because of the constitutional language, it is important to establish that you are a physician or patient.
  2. Please include relevant information such as medical literature, randomized controlled trials, observational studies, medical and scientific opinions, and scientific data demonstrating medical efficacy for the condition you wish to add.​
 
​What happens with your petition?
The MMR rules require the department (typically the executive director’s designee) to:
  1. Review the information submitted in support of the petition.
  2. Conduct a search of the medical literature for peer-reviewed published literature of randomized controlled trials or well-designed observational studies in humans concerning the use of marijuana for the condition that is the subject of the petition using PUBMED, the official search program for the National Library of Medicine and the National Institutes of Health, and the Cochrane Central Register of ControlledTrials.
  3. Review the medical literature.
 
Department determination
MMR rules require the department deny a petition to add a debilitating medical condition within (180) days of receipt of such petition without any hearing before the Board of Health in all of the following circumstances:
 
  1. If there are no peer-reviewed published studies of randomized controlled studies nor well-designed observational studies showing efficacy in humans for use of medical marijuana for the condition that is the subject of the petition.
  2. If there are peer-reviewed published studies of randomized controlled trials or well-designed observational studies showing efficacy in humans for the conditionthat is the subject of the petition, and if there are studies that show harm, other than harm associated with smoking such as obstructive lung disease or lungcancer, and there are alternative, conventional treatments available for the condition.
  3. If the petition seeks the addition of an underlying condition for which the associated symptoms that are already listed as debilitating medical conditions for which the use of medical marijuana is allowed, such as severe pain, are the reason for which medical marijuana is requested, rather than for improvement of the underlying condition.
 
The circumstances above are the conditions of denial. If the conditions of denial are not met, the department is required to petition the state Board of Health within 90 days of receipt of a petition for a rulemaking hearing to consider adding the condition to the list of debilitating medical conditions.
 
Board of Health determination
To add a debilitating condition, the MMR rules need to be modified. The department pursues rulemaking through the standard Board of Health processes. A rulemaking packet is completed. Along with proposing language to add a debilitating condition, a regulatory analysis is completed. Stakeholders may provide the department feedback during the rulemaking process or stakeholders may submit written testimony to the Board of Health. For more information go to Participate in the Board of Health.
 
Although there are no specific criteria the Board of Health must apply when considering a rulemaking request from the department to add a debilitating condition, the board may rely on 1-3 above under “Department determination.”