Colorado’s Regulated Natural Medicine Program At-a-Glance
Facilitators will hold one of three primary license types: Wellness; Behavioral Health; and Medical. All facilitators will be required to complete 150 hours of education, 40 hours of hands-on practicum, a BLS certification, and a 6-month consultation period before they are fully licensed to practice independently. During the 6-month consultation period, facilitators will be eligible for a training license, which will permit charging for services. The Board has also recommended a “Distinguished Educator” license to solve the chicken-and-egg problem created by requiring supervision by a licensed facilitator as part of the licensure process. The “Distinguished Educator” license would permit individuals with significant training and experience with natural medicines to provide natural medicine services only in the context of training — thereby allowing people located outside Colorado to serve as supervisors during the practicum and consultation periods. Applicants meeting certain criteria will be eligible for an accelerated training path. Facilitators will be required to adhere to an ethical code and utilize a screening tool to identify participant risk factors.
Cultivation will be limited to all strains of Psilocybe cubensis. Outdoor cultivation may be permitted at the discretion of DOR, but will require additional regulation. Natural medicine products will be limited to orally-administered products which can be produced using whole fruiting bodies or powdered mushrooms. Extractions using solvents other than water and fruit juice are prohibited. The Board chose to defer to regulators on specific cultivation practices, substrate materials, and permitted additives during cultivation. In this area, the Board has erred too far on the side of caution. By restricting extractions and product types, many participants who would benefit most from natural medicine may be shut out of the regulated market and forced underground.
The testing regime will require potency testing on each harvest batch. A “Harvest batch” is defined as all mushrooms harvested from a single flush of a single inoculation. Random, annual testing will be conducted by regulators for species ID, heavy metals, pesticides, solvents, microbial contaminants, and mycotoxins.
Recommendations on healing centers and licensed facilities generally are substantially similar to the Oregon Health Authority rules for Psilocybin Service Centers on which they are based. They consist mainly of run-of-the-mill recommendations around security, storage, alarm systems, video recordings, restrooms, food safety, animals, and general facilities safety.
In addition to concrete recommendations specific to the mechanics of the program, the board adopted recommendations for legislative changes, preferred interpretations of statutes, and the natural medicine program holistically. The Board recommended that regulators interpret statutes defining natural medicine licenses to explicitly allow cultivators and producers to sell or transfer natural medicine directly to facilitators. Similarly, the board urged regulators to interpret C.R.S. § 12-170-108(4), which permits unlicensed administration of natural medicine in the context of bona fide religious, culturally traditional, or spiritual ceremonies, broadly to allow remuneration. The Board recommended that C.R.S § 44-50-301(4) be revised to permit testing facilities to hold both marijuana and natural medicine testing licenses, due to concerns that the volume of natural medicine testing alone may not be sufficient to sustain a testing business.
A “Natural Medicine Sales Charge” was also recommended. This recommendation is necessary to support other recommendations, such as programs to expand equity and data collection efforts. Given the cash-fund nature of the natural medicine program, a funding source other than license and application fees is necessary to undertake any initiative without increasing fees.
Also included were recommendations encouraging diverse representation in the natural medicine market. One recommendation is to include underrepresented business leaders, facilitators, and the Federally Recognized American Tribes and Indigenous Community Working Group in decision-making related to the natural medicine market. Additional recommendations urge regulators to consider Indigenous guidance, regenerative agriculture practices, commercial composting, and social equity in waste disposal regulations.
The Board adopted a range of recommendations intended to expand equity in access and licensure. Many of these recommendations are contingent upon funding, either via legislative appropriation or some type of natural medicine sales charge. Most are accompanied by disclaimers that they should only be undertaken if feasible, or so long as they do not increase license costs. Recommendations of this variety include social equity licenses for facilitators and natural medicine businesses, social equity grant and loan programs, business mentorship programs, and free, remote facilitator training. More concrete, day-1 recommendations in this area include cost differentials in facilitator licenses, social equity licenses, and ensuring the state complies with C.R.S. § 12-179-113(1)(c). This provision requires that behavioral health services which are already covered under Colorado’s Medicaid plan are covered when delivered in conjunction with natural medicine services. This provision is key to ensuring access to natural medicine services for the treatment of mental health disorders.
Despite over 300 hours of scheduled meetings, some subjects were not addressed in the initial batch of recommendations. Notably absent are specific recommendations regarding “Authorized Locations other than Healing Centers”, though the board did start to contemplate what those rules might look like. Another significant gap is evident in a lack of recommendations bearing on data collection. The Board did, however, recommend that regulators collect data on, and as soon as possible consider rules around, administration of natural medicine outside of authorized healing centers. Similarly, the Board recommended that regulators generally consider collecting data without making specific recommendations.
Also notably—and laudably—absent are recommendations prescribing dosing limits and administration session lengths. Microdosing advocates will celebrate the absence of a minimum administration session length, which would have created a de facto prohibition on regulated microdosing by imposing unnecessary time and financial costs. Proponents of higher doses, and the mystical experiences they can induce, will celebrate a lack of upper dosage limit. Ultimately, dosage and administration session length should be left to the facilitator’s discretion and the needs of the participant.
Some subjects are still under construction and subject to change, such as the Facilitator Code of Ethics. Although the code was adopted as-is, an addendum was made that the Board will seek to improve points E.4-E.13 of the code dealing with relational boundaries. The code currently prohibits practices which are common in traditional and indigenous settings, such as providing natural medicine services to family members and consuming natural medicine during facilitation. Recommendations from the Indigenous and Religious Use and Outreach subcommittee are also still evolving as that subcommittee works to include more perspectives.
For a deeper dive into the entire first set of recommendations, including commentary by Vicente LLP, check out our Recommendation Roundup here.
Kicking off the January meeting of the Emergency Response, Safety, and Ethics subcommittee, the Psychedelic Public Policy Partnership (“PPPP”) presented an updated version of their participant screening tool. The latest version clearly indicates how a facilitator should proceed based on a participant’s responses to screening questions. Also included is an extensive spreadsheet of pharmacological interactions with natural medicine and associated risks. While the subcommittee unanimously praised the screening tool, the exact use of the tool remains to be determined. If the tool were to be directly incorporated into regulations, any minor changes, such as the addition or revision of a question, would require a lengthy and burdensome rulemaking process. Ultimately, the subcommittee settled on making a general recommendation that facilitators be required to use a screening tool, but not prescribing a specific tool. Any screening tool used will, however, need to collect information regarding a participant’s general health, mental health, medical health, pharmacology, spiritual or religious considerations, and other special considerations such as disability or service animals.
Next the subcommittee turned to discussing a draft set of recommendations for “Authorized Locations other than Healing Centers” where natural medicine services may be provided. The burning questions in this area are 1) whether a facilitator may provide natural medicine services in the facilitator’s home and 2) whether a facilitator may provide natural medicine services in a participant’s home. Concerns around home facilitation include conflicts with local zoning laws, risks associated with entering unknown locations, and the potential circumvention of healing center licenses if facilitators essentially operate a natural medicine business out of their own residence. Sheriff David Lucero dispelled fears of risks to law enforcement. The Sheriff acknowledged that entering unfamiliar locations is in the normal course of police work, further adding that the need to provide access to participants who may be home-bound outweighs the concerns. Erica Messenger, a rural nurse who provides in-home care, explained common safety procedures used in that profession, such as interviews and home visits. An additional consideration for residential facilitation is licensing. Allison Robinette of DOR indicated that the Department would be averse to licensing residences directly, and that allowing a facilitator to offer natural medicine services in their own home could potentially circumvent the requirement that healing centers obtain licensure. An alternative would be to license facilitators themselves, through an additional license or an endorsement, to provide natural medicine services in residences. Should the NMAB choose this route, the Qualifications and Licensing subcommittee would likely need to weigh in.
The subcommittee also considered the implications of licensing existing medical and mental healthcare facilities as authorized locations. While SB23-290 clearly contemplates allowing provision of natural medicine services in mental health and medical facilities, the mechanics of doing so present a host of new questions – such as which regulatory body would oversee that license. Assistant Attorney General Ashley Moller reminded the subcommittee that DOR and DORA are the only entities granted licensing authority under SB23-290. Consequently, the Behavioral Health Administration, which licenses addiction treatment facilities, would not be able to license locations for the administration of natural medicine.
Recognizing the complexities and difficulties inherent in licensing locations other than healing centers, the subcommittee agreed to revisit the subject in more depth in the second round of recommendations. To ensure that the subject was acknowledged in the first round, the subcommittee adopted a generalized recommendation that “[The] regulatory agencies should collect data on processes involved in licensing authorized locations other than healing centers for the facilitation of natural medicine.” This will encourage regulators to, among other things, solicit input on other authorized locations as part of upcoming public engagement work.
Finally, the subcommittee briefly discussed the Facilitator Code of Ethics. A single subsection, requiring a facilitator to conduct a risk screening, was struck to avoid duplication with an identical recommendation adopted earlier. One non-voting participant suggested including information specific to grievance filing, however it was agreed that the required informed consent process should sufficiently address that concern.
The meeting concluded with a motion to adopt the recommendations of the subcommittee, including amendments.