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Colorado Natural Medicine Advisory Bulletin #10: March 2024

By Vicente LLP, Psychedelic Alpha

Apr 6, 2024

Vicente LLP is proud to collaborate with Psychedelic Alpha—an independent newsletter and community in the field of psychedelics—on the Colorado Natural Medicine Health Act Tracker, which includes high-level statistics, anticipated recommendations, and regularly published Natural Medicine Advisory Bulletins. The bulletins will provide updates from Natural Medicine Advisory Board meetings, along with other important information related to the implementation of the NMHA and psychedelics reform in Colorado.

The primary focus of the March 15 meeting of the Natural Medicine Advisory Board (“NMAB”) was to review, and provide its input on, stakeholder feedback received on draft rules for Facilitator licensing and training, which were released in February. Members of the public, many of whom provided detailed, thoughtful feedback on the draft rules, were likely disappointed by what transpired. Public stakeholders submitted over 139 pages of written comments, and dozens of additional oral comments during the stakeholder meeting, however, no public comments were read aloud during this month’s meeting of the NMAB. Instead of engaging directly with stakeholder feedback, the Board addressed generalized topics provided to the Board via an opaque process. Further, it appears that at least some Board members neglected to review public comments beforehand.

The most frequent response to stakeholder feedback by the Board was to request more information or context from the public, information which was often available in the detailed comments already provided. This common response would appear to be symptomatic of the way in which stakeholder feedback was presented to the Board for discussion. According to the Assistant Attorney General, public comments were grouped into topics which the Board discussed as a whole. While this strategy is reasonable when considering the alternative of individually discussing hundreds of comments, the fact that the comments were filtered for the Board and some Board members did not review the public comments, led to a self-affirming discussion that lacked meaningful review of the constructive criticism of the rules offered by the public.

A frequent piece of stakeholder feedback – that medical clearance should not be required for participants with specific conditions – was completely omitted from the discussion. Meanwhile, suggestions made by a single commenter, such as adding an additional license type for researchers, were floated to the top for Board discussion. The generalized topics provided to the Board lacked context provided by commenters, often leaving the Board unable to engage in meaningful discussion of the issue or feeling the need to request more information.

To be sure, bridging communication between the Board and a sizable, deeply invested public is no small feat for state regulators. Under the current process, the NMAB makes recommendations to state agencies. The agencies then draft rules based on the Board’s recommendations. The public provides feedback on draft rules during stakeholder meetings. Stakeholder feedback is then provided to the NMAB. After reviewing stakeholder feedback, the NMAB may amend its recommendations. Agencies incorporate the Board’s new recommendations into updated draft regulations, and the process repeats. This board recommendation-regulatory rule-stakeholder feedback framework may feel cumbersome to some members of the public, but as with regulated natural medicine broadly, regulatory agencies are in uncharted territory with this level and style of public engagement. 

As regulators continue to refine the process and work out the kinks, hopefully the consolidated subcommittee and the entire NMAB will meaningfully review, consider, and incorporate when appropriate, public comment into their future recommendations.

Administratively, Department of Regulatory Agency (“DORA”) officials shared that the NMAB's 2024 meeting schedule has been finalized. Work is underway at DORA to flesh out the definitions section of the draft rules as well as the section on standards of practice, which will incorporate the Facilitator code of ethics.

Department of Revenue (“DOR”) representatives gave an update on the ongoing work of DOR’s Natural Medicine Division. DOR has completed its first public resource related to natural medicine, a “Know the Law” brochure regarding personal use, available in English and Spanish. The Department is also creating a specific web page to house current and future natural medicine-related resources.

Regarding the Department’s rulemaking timeline, DOR has elected to file two separate notices of permanent rulemaking. The first notice covers substantive rules for licensed natural medicine business. The notice includes eight work groups and culminates in a permanent rulemaking hearing on July 25th, 2024. The second round of rulemaking proceedings will focus exclusively on fees, and a rulemaking notice will be published in summer 2024. DOR continues to keep its goal of effective rules by October 2024 and expects to make draft application forms for natural medicine businesses available in May 2024. DOR will begin accepting applications through an online portal no later than December 31st, 2024. Additionally, beginning in January of 2025, the Department hopes to offer applicants the option to meet in-person with a licensing specialist.

Having completed eleven informal “Listening Sessions,” DOR has moved into the formal public engagement portion of the rulemaking process. In this next phase, the Department will host eight “work groups,” each focused on specific topics. The first work group, which took place on March 20th, focused on owner and worker licenses and financial interests of licensees. Ms. Mendiola gave a high-level overview of key subjects the first work group would focus on. Under the Department’s current draft rules, owners of Healing Centers will require a specific license that appears to be separate from the licensing of the actual facility. Additionally, Healing Center employees that possess unrestricted access to natural medicine must be licensed. Facilitators who are employed by, or provide natural medicine services at, a Healing Center will also be required to obtain an employee license, however the employee licensure process for facilitators will be streamlined and will not impose any additional fees on facilitators.

Finally, the Department will prioritize applications for licensed natural medicine business in which one or more owners has a tribal or indigenous background in natural medicine; one or more owners who is a veteran; or include a community impact plan that demonstrates that the natural medicine business:

  • Will be located in, or serving, rural communities
  • Will offer discounted or free natural medicine services
  • Will have sustainability measures in place to minimize negative environmental impacts related to the cultivation, manufacturing, testing, storage, distribution, transport, transfer, and dispensation of regulated natural medicine.

The real substance of the meeting consisted of Board members reviewing public feedback received in DORA’s Stakeholder Engagement Meeting. Unfortunately, the nature of the current feedback process meant that the Board was unable to meaningfully discuss much of the public’s feedback.

State officials reduced over 139 pages of written comments and one hour of oral comments to the following handful of topics, which the Board used to guide discussion.

1. Facilitator Licensure

  • Include in Rule 2.2(C) licensed naturopathic doctors, registered nurses, and recreation therapists as those types of licensees who qualify for licensure as a clinical facilitator;
  • Create a researcher license;
  • More specifically define what is required for accelerated licensure pathway for legacy healers so that legacy healers know what they need to prove;
  • Be more flexible in licensure requirements for legacy healers.

2. Definitions or use of certain terms

  • The terms in Rule 2.2(A)(6) are not clinically relevant or defined;
  • Remove the reference to “psychotropic medication” in Rule 2.2(A)(9). Lithium is the only medication that is contraindicated.

3. Facilitator Training

  • Allow hours in ketamine-assisted therapies to count toward practicum/consultation hours;
  • Consider the fact that many participants who do not carry “diagnosed conditions” may still have walking trauma and your Facilitators may be out of their depth with the lack of training (because they need hundreds of hours of exposure/experience);
  • Consider whether to require student trainees to develop a rescue plan while in supervision/consultation periods (even if it is to simply call 911);
  • Will Canadian training programs qualify for licensure?;
  • Will out-of-country facilitators be able to get licensed?;
  • Should training programs have a module on sound legal and business training?;
  • Remove the requirement for practicum to run 5-6 administration sessions, but keep the requirement at 40 hours;
  • Recommend classes in harm reduction and microdosing.

4. Training Programs

  • Reassess rules to allow for the financial sustainability of smaller programs;
  • Reconsider all of the requirements for training programs, like career counseling, because they are not fully relevant to facilitator training.

5. Participant Screening

  • Remove requirements from rules related to participant screening in favor of the use of a safety-based screening tool and informed consent.

Getting into the first set of topics, related to facilitator licensure, the Board first discussed the addition of Naturopathic Doctors (“ND”), Registered Nurses (“RN”), and Recreation Therapists as types of licenses that would qualify for Clinical Facilitator Licensure. Many members of the public submitted feedback supporting the expansion of professions eligible for the Clinical Facilitator license, however, the Board was somewhat dismissive of this feedback. Several members stated that there was no intention to modify other licensed scopes of practice and that an ND who is licensed as a general facilitator is not precluded from performing services they are licensed to provide under their ND license. Instead, according to Dr. Alisa Hannum, the Clinical Facilitator license is intended for situations in which someone is being diagnosed and/or treated for a specific condition in conjunction with natural medicine services. In such situations, therefore, a Clinical Facilitator would also need to be licensed to diagnose and treat that condition. The Board received legal advice on this issue during an executive session, out of the view of the public. Following the executive session, the Board chose not to recommend expanding the list of licensed professionals eligible for the Clinical Facilitator license, emphasizing that Naturopathic Doctors and Registered Nurses are able to obtain the Facilitator license.

The Board next addressed a suggestion of an additional “research license,” which was suggested by a single stakeholder. Here the convoluted nature of the public feedback process was on full display. NMAB members were unclear from the generalized discussion topic what was meant by this commenter. Rather than refer to the comments directly, the Board speculated on several potential meanings of the comment. According to Dr. Bradley Conner, someone wishing to conduct research by observing facilitation sessions could be accommodated through an informed consent process. If someone wanted to conduct research while facilitating, they would need to possess a full facilitation license. Another possibility, suggested by Dr. Sue Sisley, interpreted the request as being similar to an analytical research license in the cannabis industry. According to Dr. Sisley, this license allows for the study of cannabis as a substance, separate from a testing license for products entering the market. After several minutes of essentially guessing at what a research license would entail or be used for, the Board concluded it needed additional information to take a firm position, but felt generally that there is not a need for a research license. Concluding this conversation, Dr. Clarissa Pinkola-Estés provided a voice of reason, calling out the limitations of one-way conversations and highlighting the need for true dialogue rather than attempting to imagine what was meant by a comment.

Moving on to a handful of questions related to accelerated licensure pathways, the first topic was a request to more specifically define accelerated licensure requirements for legacy healers. The resulting conversation quickly became convoluted, with some members providing thoughts on whether experience with ketamine and MDMA-assisted psychotherapy should count towards accelerated licensure. The Assistant Attorney General steered the conversion towards two similar but ultimately different questions. First, they characterized a group of related comments as requesting more specificity as to what “substantially equivalent training” would entail for accelerated licensure of legacy healers. Second, whether experience or training in ketamine or MDMA-assisted psychotherapy should be accepted for accelerated licensure applicants.

On the first question, the Board again expressed a need for additional context from the public. Dr. Alisa Hannum, who chairs the Qualifications, Licensing, and Training subcommittee that recommended accelerated licensure, pointed out that the suggested criteria for legacy healers were made intentionally flexible, to allow for a range of education and experiences. The Assistant Attorney General and Dr. Hannum agreed that more rigid accelerated licensure criteria in the rule might ultimately work against the Board’s intention to be as inclusive as possible to legacy healers.

Regarding whether experience with ketamine or MDMA-assisted therapy should count towards accelerated licensure, the Board generally agreed on “maybe.” Skippy Upton-Mesirow pointed out that, while there may be some overlap in the skills and experience of ketamine or MDMA-assisted therapy to natural medicine, there may also be essentially none. For example, providers who prescribe mail-order ketamine, or ketamine clinics which lack a psychotherapy component. Additionally, the wide variations in ketamine-assisted training programs and degrees of ‘facilitation’ across the ketamine space make defining a clear equivalency to natural medicine facilitation or training difficult. Several board members agreed with Mr. Mesirow that some hours may count, but determining whether or not they do requires quite a bit of nuance. Dr. Sophia Chavez provided the perspective from the indigenous community. According to Dr. Chavez, many in that community feel that lab-made substances possess a different spirit than natural medicine, and are thus not necessarily equivalent. Ever the voice of inclusivity, Dr. Pinkola-Estés suggested convening a committee of persons affected by accelerated licensure rules to assist in determining what the bar should be.

The Board then discussed “flexibility in licensure for legacy healers,” again a broad generalization of multiple public comments. Several members of the Board felt that the task of determining what “substantially equivalent” experience or training is for legacy healers should fall to the discretion of DORA. Lorey Bratten clarified that DORA will indeed be evaluating accelerated licensure applications and that there will be an appeal process for legacy healers who disagree with DORA’s determination. Dr. Pinkola-Estés once again emphasized the need to include the voices of those affected when making these determinations, suggesting a committee. Dr. Sophia Chavez concurred, adding that the body evaluating applications of legacy healers should include elders and individuals who truly understand the work and training of legacy natural medicine healers. Once again, Chair Lundy requested that members of the public provide more context of what more specificity or flexibility would look like.

The second section of discussion topics related to “Definitions and use of certain terms in draft rules.”

The first topic concerned the lack of clear definitions and clinical relevancy of terms used in [draft] rule 2.2(a)(6). Disappointingly, the Board did not address this piece of feedback whatsoever, pointing to the fact that the definitions section of the rules are still under construction and moving on to a suggestion that the term “psychotropic medication” in rule 2.2(a)(9) be removed – which is a positive development.

Multiple stakeholders pointed out that “psychotropic” is an extremely broad term, and that lithium is the only medication for which there is data indicating that psilocybin may be contraindicated. Drs Alisa Hannum and Bradley Conner defended the inclusion of the language, stating that in addition to possible pharmacological contraindications, taking psychotropic medication may be indicative of a mental health condition that would require additional consultation prior to consuming natural medicine. Dr. Conner also pointed to the fact that some medications can affect the dosage required to achieve a certain experience. Dr. Pinkola-Estés again suggested getting additional opinions. Dr. Sue Sisley, an actual medical doctor, expressed reservations about making hard-line rules based on what are mostly theoretical interactions. Dr. Sisley pointed out that all clinical studies to date have used a synthesized, isolated psilocybin molecule and intentionally excluded many populations for whom natural medicine may be most needed for healing.

Next, the Board discussed several topics related to facilitator training.

Based on the previous discussion, the Board appeared to agree that ketamine or MDMA-assisted-psychotherapy hours should not count as equivalency for the purposes of practicum and consultation hours.

Regarding a stakeholder concern that facilitators may be working with individuals with undiagnosed trauma, several board members acknowledged this reality, but felt there was little more that could be done beyond the current screening mechanisms, guard rails, and the addition of trauma training to the required training curriculum.

A comment suggesting that student trainees be required to develop a rescue plan was met with yet another request for clarification from Dr. Brad Conner, who pointed out that a safety plan is already required.

A question of whether Canada-based training programs would qualify for licensure was answered by deferring to how the regulating authority would handle it. According to the Assistant Attorney General, the guidance from the Board indicates that, as long as an applicant can demonstrate substantial equivalency in training, the country the program is based in would not be relevant.

Regarding whether training curriculums should include business and legal training, Chair Lundy recalled that the idea was previously rejected by the Board in favor of keeping training costs low, and because business training may not be universally needed. Several board members agreed that business training should be available to those who need it, but should not be required as part of the facilitator training curriculum.

A suggestion that the practicum requirement does not include the language “Approximately 5-6 administration sessions” was not addressed, however, most members agreed that they would not support lowering the current 40-hour practicum requirement.

Recommendations from the public to add education on microdosing and harm reduction to the required curriculum elicited modest support but were not fully embraced.

Moving on to a set of topics related to training programs, the first generalized piece of public feedback was to “reassess rules for the financial stability of smaller training programs.” DORA Natural Medicine Program Director Lorey Bratten clarified that the organizational and administrative requirements of section 4 were drafted by DORA, based on their experience approving training programs such as those for nurses. Dr. Alisa Hannum noted that rules for approving nurse training programs are heavily based on university models, while facilitator training programs generally are not. Similarly, stakeholder feedback urging reconsideration of certain program requirements, such as career counseling, as not relevant to facilitator training programs, stemmed from the same DORA-provided rules. Recognizing the need to assess this set of rules as a whole, the Board will discuss the entirety of section 4, regarding training program approval, in the combined subcommittee meeting on April 12.

The final topic provided to the Board for discussion was “Removing requirements for screening in favor of safety-based screening and informed consent.” This generalized version of one of the most frequent pieces of stakeholder feedback perfectly encapsulated the issues inherent in the current process. The topic statement lacks the context provided by the many stakeholders who commented on the issue, poignantly evidenced by the first board member’s response of “What does that mean?” To those who read the related public comments or attended the stakeholder engagement meeting, it is clear that many stakeholders oppose hard-coding into rule conditions that impose additional burdens on participants, such as medical clearance requirements or forcing a participant to see a clinical facilitator. Those stakeholders advocated for a screening process that allows for more nuanced assessments of participant’s risks and needs, as opposed to rigid regulatory rules that strip facilitators and participants of autonomy and choice. Dr. Bradley Conner appeared to interpret the comment as a request for a screening tool generally, pointing to the screening tool developed by the Psychedelic Public Policy Partnership, some version of which the Board expects to be made available to facilitators. Dr. Alisa Hannum also misunderstood the thrust of the stakeholder feedback, feeling that the issue would be worked out when facilitator scopes of practice are defined. Board member Skippy Upton-Mesirow most correctly understood the topic, distinguishing an initial process to determine which type of facilitator a participant sees from a later screening used by facilitators to ascertain specific information a facilitator should be aware of. Current draft rules would rigidly, and imprecisely, prescribe which facilitators can work with which participants. Ideally, facilitators could work with participants to determine the correct path based on the participant’s history and goals and the facilitator’s abilities.

Chair Lundy then opened the floor for an open discussion on any additional subjects Board members wished to discuss. Dr. Conner expressed concern that codifying the ethical code into a rule, as Program Director Bratten indicated is underway, would create a cumbersome modification process. Dr. Conner wondered if the ethical code could instead be incorporated by reference, which would allow the ethical code to be updated without the need for formal rulemaking. Dr. Pinkola-Estés raised the question of whether an elder, who meets the requisite criteria, would be permitted to train facilitators in their own lineage or tradition.

Both questions were reserved for the executive session, which the Board then entered for nearly an hour.

Upon exiting the executive session, Chair Lundy announced that the Board would not recommend expanding the list of professions eligible for Clinical Facilitator licensure. Dr. Alisa Hannum emphasized that the general facilitator license is open to anyone, and suggested that a facilitator license could provide a marketing benefit to individuals who can claim they are, for example, a Naturopathic Doctor as well as a Natural Medicine Facilitator.

Dr. Pinkola-Estés raised the issue of “Facilitator” being a widely used term. Were the state to define the profession simply as ‘Facilitator,” thus protecting and preventing others from using it, many professionals using the term in some general fashion would be jeopardized in addition to confusing the public. She suggested adding a modifier to avoid confusion and unnecessarily penalizing lay uses of “facilitator.” The Assistant Attorney General pushed back on the suggestion, claiming “Facilitator” is defined by statute and thus unable to be changed. To explain what the Board and regulators may do, the Assistant Attorney General used an analogy comparing a regulatory structure to a body. In the analogy, statutes form the skeleton and are set by the state legislature. The muscles and tendons are created by rules, which are within the purview of the Board and regulators and require rulemaking to modify. Policies, which comprise the skin in the analogy, are able to be set and modified by regulators through informal means. Mr. Upton-Mesirow concurred with Dr. Pinkola-Estés on the potential problem of claiming “Facilitator” generally, offering a simple solution of “Natural Medicine Facilitator” as the official license and professional name.

Briefly addressing the participation of elders in facilitator education, Dr. Pinkola-Estés shared a story of meeting with local Indigenous elders and advocated for more proactive outreach by regulators to include their perspectives. Dr. Conner wondered if an “approved trainer” analogous to an “approved training program” but for an individual, could be possible and suggested the issue be discussed in the upcoming subcommittee meeting.

Chair Lundy then closed the meeting. The combined subcommittee will meet Friday, April 12, 2024. The full Natural Medicine Advisory Board will meet the following week on Friday, April 19, 2024.

In addition to a more meaningful engagement with public feedback, the Board will hopefully address some of the remaining questions around group facilitation, residential facilitation, and the need for rules that are flexible enough to accommodate incorporating natural medicine into existing mental health businesses as a supplemental therapy option.

The public may continue to submit written comments on draft rules related to facilitator licensing and training through May 3 via email to dora_dpo_rulemaking@state.co.us.

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As formal rulemaking approaches, there will be increasing opportunities for public engagement. Stay tuned to our Natural Medicine Advisory Bulletin for the latest news on Colorado’s natural medicine program, as well as upcoming opportunities to get involved.

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