Colorado Natural Medicine Advisory Bulletin #3: August 2023
By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Sep 7, 2023
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.
Five of six subcommittees, plus the full NMAB met in August. The Harm Reduction and Public Safety Committee did not meet and was dissolved by the full NMAB on August 18. Updates from each subcommittee that met, as well as the Natural Medicine Advisory Board, are shared below.
Separately, the Department of Revenue (DOR) presented at each meeting about the department’s upcoming listening sessions which will begin in September. It will be interesting to see how DOR takes on its duties to regulate the business side of natural medicine through its new Natural Medicine Division. More information is available on the Natural Medicine Division website.
Five months into NMAB efforts, several themes and interrelated issues are emerging as the work of the subcommittees converges. The NMHA seeks to honor and integrate Indigenous wisdom and practices into the natural medicine market, yet these practices are at times in tension with regulation. Practices such as facilitators consuming natural medicine with participants and administration of natural medicine outside of licensed healing centers are presenting barriers to insurance coverage and security-related regulations. Those insurance barriers and regulations have implications for equity in licensing and access costs. Common practices in underground therapy circles such as intuitive supportive touch are proving hard to codify. The question of whether video cameras will be required in healing centers touches on cultural beliefs, questions of federalism and privacy, and equity concerns related to cost. Standing up a federally prohibited program that bridges Western and Indigenous medicine is no small task and the members of the NMAB have been hard at work on these questions and more.
So how are they doing? Read on to find out.
The Emergency Response, Safety, and Ethics subcommittee received a presentation from the Fireside Project, a call-in psychedelic peer-support organization. The key takeaway from this conversation was that educating the public about the service could potentially reduce 911 calls related to individuals experiencing distress after consuming natural medicine. The subcommittee also heard from Emily Holcomb about the state’s Mobile Crisis Response program and discussed the possibility of integrating psychoactive crisis-informed response into the program.
In discussion the subcommittee weighed allowing facilitators to consume natural medicine alongside participants, a practice common in many Indigenous and culturally traditional settings. It appears unlikely that the NMAB will recommend allowing facilitator consumption for liability and insurance reasons, however, the possibility of allowing exemptions was raised. The group continues to wrestle with the implications of NMHA provisions allowing the facilitation of natural medicine services outside of healing centers. Here the subcommittee is in uncharted territory. Oregon Health Authority regulations, which have served as a baseline for much of this subcommittee’s work, only permit consumption in licensed service centers.
One of the larger hurdles for the subcommittee centers on security requirements. Oregon’s program, as well as Colorado’s cannabis regulations, generally require security systems, alarms, and cameras in licensed facilities. Crafting a workable set of security regulations for a potentially limitless number of settings has thus far raised more questions than answers for the subcommittee.
Revisiting Dr. Bradley Connor’s ethical code for facilitators, the subcommittee addressed another difficult question—What are the limits of allowable touch during the facilitation of natural medicine services? The first draft of the ethical code assumed either the presence of a second facilitator or video recording to safeguard against abuse, however, concerns about costs, video recording of federally illegal activity, and cultural aversion to capturing the sacred process of healing have weighed heavily against such a requirement. For the time being, it appears that the subcommittee will recommend that an informed consent process include disclosure of the potential for abuse and offer participants the option to request either an additional person be present or the session be recorded.
The next steps for this subcommittee involve drafting working definitions for “at-home” or “offsite” consumption, drafting a definition of “harm reduction,” updating the ethical code, and hearing from facilitators who consume natural medicine during their facilitation practices.
Next Meeting: September 13th, 2023, 1pm MST
Public Health & Health Equity had five additional non-voting participants join this month’s discussion. The new additions include:
- Matt Brockmeier: Attorney with Emerge Law Group; experience in healthcare and cannabis;
- Mellisa Palmer: Clinical social worker, attorney, professor at the University of Colorado, Director of the MS in Palliative Care program,
- Andrew Nocick: Assistant Professor of psychiatry at the University of Colorado; co-investigator for psilocybin as treatment for distress in advanced cancer;
- Liana Gillooly: Strategic Initiatives Officer at MAPS, board chair of Northstar;
- Tristan Watkins: Colorado’s Deputy Director for the Cannabis Business Office;
- Rochelle Galey: Licensing Program Manager of the Colorado Behavioral Health Administration;
- Ean Seeb: Special Advisor to the governor on cannabis and natural medicine.
Continuing a discussion from the previous subcommittee meeting, Dr. Tina Gonzales presented a draft document on principles and recommendations intended to support equity in the regulated natural medicine market. High-level concepts included avoiding tokenization of indigenous perspectives, the need for multiple perspectives to coexist simultaneously in the natural medicine space, how the efficacy of natural medicines may be reduced by separating them from the holistic healing processes that traditionally accompany their use, educational materials supporting the acceptance and use of natural medicine, and leveraging state databases to support pharmacoequity1. Specifically, Dr. Gonzales suggested that DORA designate an agency to lead equity activities. Those activities would include conducting regular community needs assessments, leveraging data to identify healthcare disparities, and developing action plans to improve health equity through the use of Natural Medicine.
The subcommittee also heard a presentation from TheraCover, a company that will offer insurance coverage for facilitators of psychedelic therapy. TheraCover intends to offer medical malpractice and liability insurance for providers utilizing ketamine, psilocybin (in states that have legalized it), and MDMA (once approved by the FDA). Unlike other insurance policies which may leave practitioners offering psychedelic-assisted therapies exposed to liability, the company has specifically designed its offerings for this newly developing market. Policy premiums would be relative to the level of licensure and risk involved for the practitioner. At the low end, the company quoted $600-$700 for sitter-type facilitation insurance. Annual premiums may be as high as $8,000-$9,000 for a medical professional administering psychedelics to high-risk patients. There were also suggestions that insurance may be even more difficult for facilitators providing natural medicine services at a participant’s home.
Board member Lundy briefly presented the latest version of their suggested equity initiatives. This version adds information on whether the initiative represents a present need or a future need as well as whether the initiative would apply to an individual, business, or both.
New suggestions included routes to licensure by endorsement, allowing donations for Indigenous, religious, or spiritual use, as well as a sales tax on Natural Medicine and a mechanism allowing for direct cultivator to healing center relationships. The suggested sales tax of 10% would be allocated to Indigenous groups, harm reduction, environment, and equity initiatives. It’s worth noting that any sales tax would have to involve another state-wide vote to comply with the Taxpayer’s Bill of Rights (TABOR).
At a high level, the group discussed how equity initiatives may add to the overall cost of the program which could work against their overall goal of increasing equity.
The next steps for the subcommittee are consolidating and organizing their work into a single document and selecting some of them for recommendation to the full board.
Next Meeting: September 14th, 2023 at 1pm MST
Having solidified their first round of recommendations in July, the Products, Research, and Data subcommittee is now turning their attention to the finer details of regulating natural medicine cultivation and production.
To better understand how regulations impact cultivators, the subcommittee heard from Tori Ambrust, a cultivator licensed under Oregon’s Psilocybin Services program. Tori shared their perspective on cultivation and production standards that have proved challenging. Among the hurdles discussed were a requirement to cultivate in a commercial space, variations in local ordinances, and grow batch requirements stipulating that a batch of mushrooms must be harvested within a 24-hour window to be part of the same batch. Board members inquired about a range of subjects including testing costs, inventory management, and disposal of psilocybin products.
After reviewing recommendations regarding production and cultivation agreed upon in the July meeting, the subcommittee identified the need to turn their attention to the priority subjects of testing, administration, distribution, and data.
The subcommittee then discussed storage, testing, and waste disposal. While no concrete recommendations emerged around storage and disposal, the group is approaching those subjects with an eye towards avoiding overregulating while also ensuring public safety. With regards to testing, the subcommittee is taking a similar approach to avoid unnecessary costs, agreeing that testing for psilocybin and psilocin content is sufficient as a starting point.
The subcommittee also reviewed the USDA’s Good Agricultural Practices (“GAP”) for growing food mushrooms. Here the subcommittee heard opposing viewpoints with regards to how regulations impact equity for licensees. On one hand, stringent regulations at the start of the program may function as a barrier to entry for small businesses. On the other hand, if initial regulations are too lax and additional regulation is required later, as was the case in some cannabis markets, those changes may be more difficult for small businesses to adapt to. Duncan Mackie shared his experiences complying with MED regulations and audit processes at a cannabis company that follows GMP/GAP standards. The subcommittee agreed on a need for additional information before making recommendations around cultivation requirements. Specifically, NMAB member Lundy requested information on costs related to audit processes as well as upfront, fixed, and variable costs to be GMP-compliant in the cannabis industry. Lundy also requested information on core competencies in preparation for federal legalization and any cultural issues that might interact with cultivation competencies.
With the market projected to be quite small, it will be interesting what level of regulation is necessary here. Hopefully, the regulations don’t mirror cannabis which is a market designed for at-home use.
Towards the end of the meeting, the subcommittee moved to a private executive session to receive legal advice from the attorney general’s office on the following subjects:
- Whether the NMHA permits healing centers to sell NM to participants exceeding quantities that will be consumed during the administration session.
- Legal analysis of the term “synthetic” as used in C.R.S. § 12-170-104(12)(c).2
Information from the executive session was not shared or discussed publicly.
Next Meeting: September 20th, 2023 at 1pm MST
In the Indigenous and Religious Use and Outreach subcommittee, Dr. Tina Gonzales presented her document of equity principles and suggestions (also presented in Public Health & Health Equity), opening discussion around how to maximize the inclusion of diverse and potentially opposing viewpoints. To facilitate this goal, Chair Dr. Pinkola Estés suggested the possibility of NMAB members visiting Indigenous communities in person to seek their perspectives. The suggestion was well-received, with several subcommittee members expressing interest in meeting other communities where they are. In addition to clearing logistical hurdles such a trip would need to comply with Colorado Sunshine Laws and budgeting requirements. DORA staff has indicated they will explore the feasibility of the idea.
Non-voting participant Dr. Angela Beers, an outspoken critic at the MAPS Psychedelic Science 2023 conference, raised several concerns. In particular, she questioned how detribalized or other individuals with indigenous ties, but who are not part of a federally recognized tribe, will fit into the equation. Dr. Beers also questioned Dr. Gonzales’ idea of using databases to track Natural Medicine use, wary of creating systems that could be abused. Finally, she wondered how insurance companies would cover Indigenous and spiritual practitioners. Regarding data collection, Dr. Gonzales clarified that the idea of pharmacoequity is to leverage data to prevent discrimination in access to medicine. Allison Robinette of DOR commented that while the department is required by law to collect data, the board has the power to shape what data is collected.
Dr. Alissa Hannum joined the meeting to discuss the licensing model under consideration by the Qualifications, Licensing, and Training subcommittee. Dr. Beers expressed concerns about a single training program by sharing how the American Psychological Association has changed licensing requirements for psychologists to their detriment. NMAB member Skippy Upton-Mesirow interpreted these concerns as a call to ensure that facilitator licenses should be accessible, include a mix of perspectives, and consider who is creating the frameworks for the licenses.
Closing out the meeting, Chair Pinkola Estés suggested that the Registered Psychotherapist program already in use in Colorado could serve as a model for an alternative license for traditional practitioners.3
Next Meeting: September 8th, 2023, 1pm MST
Having settled, for the time being, on offering a single facilitator license augmented by other professional licenses, the Qualifications, Licensing, and Training subcommittee must now define the scope of practice for the facilitator license the state will offer. Oregon regulations expressly prohibit professionals licensed in other fields from practicing those licenses in combination with psilocybin services. Colorado’s NMHA contrasts starkly with this position; however, allowing natural medicine facilitators to practice within multiple licenses raises unique questions. Should regulations make distinctions between participants seeking natural medicine services specifically for treatment of a mental health diagnosis, and those who have a mental health condition but are seeking natural medicine services for a different reason? How would a facilitator be expected to verify a participant’s diagnosis? What claims can a facilitator make regarding the efficacy of natural medicine? As Billy Wynne reminded the subcommittee, the NMHA was passed by the people of Colorado in large part to create access to new treatment modalities for mental health.
The subcommittee engaged in a lengthy and spirited debate around what claims a facilitator can make. Several NMAB members felt that a facilitator should be separately licensed to treat a mental health condition if a participant is seeking for that condition. Participants representing legacy and lineage healers offered perspectives that view mental health conditions as inextricably linked to spiritual and emotional well-being. They shared stories of success in treating mental health conditions in underground contexts.
Further questions were raised about facilitators opening themselves to liability based on the language of claims being made. Hadas Alterman of the Psychedelic Bar Association pointed out that claiming to treat any condition without FDA approval could be viewed as making false medical claims. Here the subcommittee looked at medical cannabis programs which allow doctors to recommend cannabis to patients based on their opinion without directly claiming cannabis is a treatment for a condition. No firm recommendations were formed but the subcommittee will consider allowing facilitators to point to existing research supporting the efficacy of natural medicine for alleviating symptoms of mental health conditions.
Moving on to training program requirements, the subcommittee reviewed Oregon’s regulations as a starting point for discussion. Of particular interest is the option to complete a practicum as part of a test-out option. OHA regulations permit practicums to include “altered states of consciousness that are not drug-induced.”4 NMAB members inquired about allowing drug-induced altered states to reflect what is already happening in training programs. Without giving a firm answer the Attorney General’s office made a distinction between allowing and requiring something – the latter of which the board cannot do. The Oregon training program rules have often been criticized for being too lenient. It’ll be interesting to see if the state of Colorado will create a truly meaningful program.
Revisiting Dr. Bradley Connor’s ethical code, the meat of the discussion again centered on dual facilitator or video recording requirements and informed consent around touch. Broadly the subcommittee agreed that healing in the natural medicine context presents a need for flexibility. To that end, the subcommittee is considering recommendations that allow participants and facilitators to opt-in to the presence of a second party or recording of the administration session. They will also consider allowing participants to bring a trusted personal connection into an administration session. During this discussion, the Department of Revenue indicated that they are considering requiring licensing of some type for any person working in a healing facility.
The subject of touch presents another aspect of natural medicine that requests flexibility from the NMAB. Several perspectives were shared on the importance of allowing touch to provide support to participants. In legacy and underground settings consensual and supportive touch is often intuitive to the healer. In its current form, the ethical code places a strict prohibition on touch of a romantic or sexual nature. It also requires an informed consent process as part of preparation. Through this process, the participant and facilitator agree on the outer boundaries for the use of touch. Consent can then be withdrawn, but not granted, during an administration session.
Regarding facilitator consumption of natural medicine during administration sessions, the subcommittee is finding tension between what is currently happening and what they can reasonably recommend. To the subcommittee’s knowledge, there have been no studies that would support allowing facilitator consumption, however, several participants and board members shared that this is common practice in the real world. This question remains open for the time being.
The next steps for the subcommittee include editing OHA regulations to reflect changes the subcommittee would like to make and presenting them at the Indigenous and Religious Use and Outreach subcommittee for feedback. Dr. Bradley Connor will also be redrafting portions of the code of ethics.
Next meeting: September 21st, 2023 at 1pm MST
Harm Reduction and Public Safety did not meet and has been officially dissolved, with members moved to Emergency Response, Safety, and Ethics.
The meeting of the full Natural Medicine Advisory Board began administratively. DORA program director Sam Bahrami gave a brief update on the department’s hiring of additional staff to support the natural medicine program. Following the resignation of Katina Banks from the board, Lundy was appointed acting chair of the board to complete the current term. A new chair will be elected by the board in October. Stacie Loucks, not in attendance, was added to the board to fill Katina Banks’ seat.
The Department of Revenue gave an update on the department’s upcoming listening sessions. These initial sessions will be focused on gathering information from stakeholders to inform DOR’s work. The one-hour sessions will be recorded and open to the public. The first session, an introduction to the natural medicine program, is scheduled for September 5th. Individuals interested in presenting or sharing information at a listening session are asked to reach out to Allison Robinette at allison.robinette@state.co.us. At this time the department has scheduled the following five listening sessions:
- Tuesday, September 5th, 11:00 – 12:00 MST: SB 23-290 Overview and Introduction to Natural Medicine Division
- Tuesday, September 12th, 2:00 – 3:00 MST: First & Multi-Responder Training Meeting #1
- Friday, September 22nd, 2:00 – 3:00 MST: Public Education Campaign Meeting #1
- Wednesday, September 27th, 10:00 – 11:00 MST: Testing Program Meeting #1
- Tuesday, October 3rd, 10:00 – 11:00 MST: Cultivation & Manufacturing Practices Meeting #1
Several NMAB members were eager to attend the listening sessions. While board members are allowed to listen in to the meetings as members of the public, participation in the sessions by board members must comply with Colorado Sunshine Laws requiring notice of any meetings where board members discuss board-related business. Towards the end of the meeting, the board moved to a private executive session to discuss board members participating in the listening sessions. Upon returning, the board voted to delegate one member, plus a backup, to officially participate in each listening session.
Next, each subcommittee chair updated the board on their progress. The Emergency Response, Safety, and Ethics subcommittee has a working draft of healing center regulations based on modified OHA regulations. DORA program director Sam Bahrami indicated there is still work to be done to account for facilitation taking place outside of healing centers. The board briefly discussed camera and security requirements related to healing centers. Points raised included cultural sensitivity to recordings, difficulty anonymizing videos to comply with participant data requirements, and cost inflation. DOR intends to solicit feedback from the public on camera requirements in their listening sessions. Regulations adopted by the department are designed to be operable such that licensees are able to comply with them reasonably.
The board then engaged with Lundy’s updated equity initiative list with members supporting the idea of Indigenous reciprocity. A need for subcommittees to work more collaboratively was identified, such as integrating Dr. Tina Gonzales’ work from the Public Health and Health Equity subcommittee into Lundy’s work.
Dr. Clarissa Pinkola Estés from the Indigenous and Religious Use and Outreach subcommittee reiterated the subcommittee’s desire to have long-term practitioners integrated into the licensing model without requiring them to go back to school. She also shared the subcommittee’s desire for additional perspectives and the possibility of sending a delegation to meet with tribes in person.
Dr. Bradley Connor gave a brief update that the Products, Research, and Data subcommittee is still working through additional priority questions. The subjects of grow kits and value of including an Indigenous perspective in cultivation regulations were raised but not discussed at length.
Qualifications, Licensing, and Training chair Dr. Alissa Hannum shared that the subcommittee is working on defining the facilitator license scope of practice and training requirements, using OHA regulations as a starting point. She also requested an executive session to discuss the subcommittee’s legal questions around medical and mental health professionals treating conditions with natural medicine.
William Dunn reported that Harm Reduction and Public Safety did not have any major updates. This led the board to their final administrative task of amending the NMAB bylaws to dissolve the Harm Reduction and Public Safety Subcommittee and moving its members to Emergency Response, Safety, and Ethics. Adding the newest NMAB member brings the ERSE subcommittee to nine members. The board then moved to change the date of the next full NMAB meeting to Monday, September 25th at 1pm.
Before adjourning the board entered a private executive session to receive legal advice on the following subjects:
- Questions raised by Dr. Alissa Hannum regarding licensed medical and mental health professionals treating mental health conditions with natural medicine.
- Questions regarding NMAB delegates to DOR listening sessions.
The executive session lasted 86 minutes. Information shared in the executive session was not disclosed publicly and the NMAB promptly adjourned after the session.
Next meeting: September 25th, 1pm MST
Upcoming meetings of the NMAB and subcommittees can be found here.
Read the Natural Medicine Advisory Bulletin #1: Background
Read the Natural Medicine Advisory Bulletin #2: July 2023
View the Colorado Natural Medicine Health Act Tracker webpage
View the Colorado Natural Medicine Advisory Bulletin webpage
Psychedelic Alpha's Colorado Natural Medicine Health Act Tracker webpage and bulletins are dedicated to being a clearinghouse for the implementation of Colorado’s Natural Medicine Health Act, with a focus on the work of the Natural Medicine Advisory Board and its subcommittees.
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