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December’s meeting of the full Natural Medicine Advisory Board began with a handful of administrative updates from the Program Director, Attorney General’s office, and the Department of Revenue’s Natural Medicine Division. Notably Assistant Attorney General Ashely Moller expressed that any recommendations of legislative changes would not be included in the first round of rulemaking due to begin in early 2024. This could hamper several subcommittee efforts including a push to allow remuneration for ceremonial use and explicit statutory authorization for direct transfer of natural medicine from cultivators to facilitators.
Department of Revenue representatives Allison Robinette and Dominique Mendiola gave an update on the department’s ongoing pre-rulemaking work including the latest listening sessions. Moving into rulemaking, the department will prioritize statutorily mandated subjects including public education, first responder training, data collection, regulations for healing centers, and rules around cultivation, testing, and production. On the public education front, DOR will first launch campaigns around the current legal limits of personal use provisions and general safety information related to natural medicine. Regarding first responder training, the department is looking to equip responders with critical information around drug interactions, recognizing a mental or medical emergency as distinct from a difficult psychedelic experience, and when to use rescue medications. On the subject of data collection, DOR is looking to utilize existing resources such as Colorado Bureau of Investigations crime data and the Attorney General’s consumer protection division as a starting point to developing a comprehensive dataset. In cultivation and testing the department is weighing two broad regulatory strategies, either disallowing certain methods of cultivation to reduce the testing burden or having more comprehensive testing if certain, more risk-creating cultivation methods are permitted. Broadly the department requested that the NMAB include a rationale for the recommendations they make so the department can find ways to approximate the end goal even if a given recommendation is not feasible.
Next the board moved to reviewing the latest draft consolidated recommendations, which saw significant discussion for the first time.
Dr. Bradley Conner gave an update on the latest work in the Emergency Response, Safety, and Ethics subcommittee, describing the client screening whitepaper from the PPPP, draft definitions for authorized locations other than Healing Centers, consideration of a special license for private residence facilitation, and the new question of whether the subcommittee should recommend restrictions on types of products or methods of administration. Dr. Conner indicated that he does not expect to finalize recommendations for other authorized locations before the first round of rulemaking.
Skippy Upton-Mesirow voiced concerns with some of the subcommittee’s draft recommendations, feeling that a 1:4 facilitator:participant ratio and the lingering requirement that a second person be present for facilitation reduce the economic viability of the program. Mr. Upton-Mesirow also expressed several concerns on behalf of the Indigenous and Religious Use and Outreach subcommittee regarding conflicts between the current ethical code and traditional practices. Offering natural medicine to family members, consuming natural medicine during facilitation, combining natural medicines, and providing home cooked food as part of a natural medicine ceremony are all currently prohibited by the ethical code. Dr. Sophia Chavez echoed these sentiments and advised that 10-12 participants per facilitator would be a more appropriate group facilitation limit. Dr. Sue Sisley took issue with the suggested 30mg dose ceiling, citing ongoing studies using a 50mg dose without issue. Dr. Conner offered a compromise of potentially recommending a dose ceiling “in line with published research”. Broadly there still appears to be a misunderstanding amongst the board, with several members defending recommendations as only applying to the regulated market and therefore not restricting activity in the ceremonial use space. Meanwhile advocates of the Indigenous and Religious Use subcommittee perspective are calling for the board to accommodate traditional practices within the regulated market – which seems to be the most appropriate.
The next update came from Billy Wynne and the Public Health & Health Equity subcommittee. He shared three updated recommendations that were approved unanimously:
- The state should include equity to the extent feasible in annual report.
- The state should offer to the extent feasible a payment over time system.
- The state should promulgate rules allowing facilitators to acquire Natural Medicine independent of Healing Centers to the extent possible; if not possible the legislature should clarify as much in statute.
Mr. Wynne also shared one recommendation that was approved 4-1:
- The state should promulgate rules allowing facilitation in the private residence of a facilitator and a participant.
The board then discussed several other recommendations from the subcommittee. Dr. Bradley Conner worried that a recommendation that data collected be made available to the public could be misinterpreted if not accompanied by additional explanation. Dr. Josh Goodwin and Mr. Wynne provided additional context that the goal of the recommendation is to provide useful research data beyond the current, limited clinical trial data.
Citing a recent article in JAMA raising the specter of federal action in state-regulated psychedelics markets, Dr. Sue Sisley expressed trepidation about a recommendation that the state take the statutorily-mandated step of allowing Medicaid billing for existing, covered services delivered in conjunction with natural medicine services.
The board also discussed the prospect of at-home facilitation. When there was broad agreement that facilitation in a participant’s home is necessary and feasible, allowing facilitators to offer natural medicine services in their own home has elicited more resistance from some board members. Local zoning ordinances, safety concerns, set and setting, regulatory overhead, access to care, and high costs of operating a licensed healing center are all at play in the residential facilitation question. Sitting at the intersection of multiple subcommittees, the question of at-home facilitation is poised to be one of first major compromises required in the NMAB.
Dr. Clarissa Pinkola-Estés shared the Indigenous and Religious Use and Outreach subcommittee’s big update – a list of accelerated licensure criteria for Indigenous practitioners. The subcommittee is broadly recommending a flexible application that allows for some combination of the following to provide sufficient evidence of a facilitators abilities to exempt them from the prescribed training:
- 3-5 years documented apprenticeship;
- Outlines of how a facilitator prepares for, conducts, and integrates a facilitation session or ceremony;
- Documentation of teachers/students/mentorship;
- References from teachers, peers, elders, and clients;
- Essay on the facilitator’s own healing journey;
- Interviews with the facilitator;
- Live demonstration of the facilitators ability.
Dr. Pinkola-Estés also shared a second suggested “generational” pathway to licensure for those who come from a community of healers. This pathway would rely on an inter-tribal council, to be established by the state, to vouch for individuals in the community as component facilitators in lieu of training or providing evidence of experience. Finally, Dr. Pinkola-Estés reminded the board of the need to suggest a legislative change to allow compensation for ceremonial use and urged the board to avoid over regulation that would stifle volunteer and community-based natural medicine services.
The Products, Research, and Data and Qualifications, Licensing, and Training subcommittees had not yet met at the time of the full board meeting and did not provide updates.
The board then entered a 32 minute, closed-door executive session to receive legal advice on interpretations of the bona fide ceremonial exemption and whether natural medicine cultivated outside of Colorado is prohibited by statute.
The next meeting is scheduled for January 14th, 2024 at 1pm MST.