Colorado Natural Medicine Advisory Bulletin #7: December 2023
By Joshua Kappel, Jeff Fitzgerald, Psychedelic Alpha
Jan 18, 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.
With several subcommittee cancellations and an abbreviated meeting of the full board in November, the Natural Medicine Advisory Board (NMAB) had quite a bit of ground to cover in December to meet their goal of submitting an annual progress report in early 2024.
The month was jam-packed with a full schedule of NMAB meetings, many taking the full four hours to wade through dense subject matter. The Department of Revenue (DOR) also completed its second round of Listening Sessions (our roundup of those sessions is forthcoming), for a total of nearly 30 hours of natural medicine-related meetings in December.
As the board races to complete as much as possible in the coming weeks, it is becoming increasingly apparent that some subjects – such as what qualifies as an authorized location other than a healing center for provision of natural medicine services – may not make it into the initial round of rules, which will form the foundation of the regulated natural medicine program.
While some may find the lack of a fully comprehensive first rulemaking disheartening, the board remains diligently at work, making significant headway in several complex subject areas. An accelerated training path for facilitators is beginning to take shape. The board has backed down from a controversial 30mg dose ceiling (though disappointingly did not address the de facto prohibition on microdosing created by a 3-hour minimum administration session length).
Of course, additional questions continue to arise and questions thought to be settled reveal their shadow side. How will the state conduct laboratory proficiency testing with only a handful of labs anticipated to possess the proper accreditation when the program launches? How many facilitator-type licenses will there actually be? (Spoiler: The current count is five). How will the board solve the chicken-and-egg problem created by requiring a licensed facilitator to supervise a facilitator-in-training, before the state has licensed a single facilitator?
As the work of several subcommittees converges, both disagreement and compromise are on the horizon. Issues like whether a facilitator can provide natural medicine services in their own residence have opposite answers in different subcommittees. For the first time, the meeting of the full board saw cross-subcommittee debate over some recommendations.
More fundamental disagreements are also beginning to emerge, such as what degree of berth the state should give to federal law. The more cautious among the board members are showing trepidation, preferring to avoid conflicts with federal law wherever possible. Other members, as well as many members of the public, have been vocal that the very premise of the program conflicts with federal law and, more importantly, the voters of Colorado have explicitly spoken on the issue.
Which of these questions will be answered in time for the first round of rulemaking? Which of the broad philosophical camps will win the day regarding conflicts of federal and state law? How many facilitator licenses will there really be?
To form your own opinion, embark on a journey deep into the mind of the Natural Medicine Advisory Board below…
Meeting for the first time since October, the Indigenous and Religious Use and Outreach subcommittee began their December work by discussing what qualifications or indicators of competence they would consider sufficient for an accelerated facilitation training waiver. The subcommittee held similar views on requirements and agreed on the following list:
- 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.
The subcommittee identified several potential hurdles in this framework including the difficulty in contacting remote or passed away teachers, inability of some legacy facilitators to read and write, differing world views and language for natural medicine concepts, and who would verify the information provided. The subcommittee broadly agreed that the body verifying the information should have significant experience working with natural medicine and that the list of qualifications should be more flexible than rigid, allowing a holistic combination of the criteria to qualify.
Next the subcommittee considered a “generational license pathway.” This pathway would only be available to members of federally recognized tribes and indigenous communities. Drafted by Dr. Tina Gonzales, the proposal would require the state to establish a collaborative tribal council. The council would be able to approve a practitioner as qualified based on the facilitator’s reputation and work in the indigenous community, bypassing the facilitator training requirements. The subcommittee did not reach a clear position on the proposal.
The subcommittee will review the consolidated draft recommendations of other subcommittees at the next meeting, which is scheduled for January 12th, 2024.
In the December meeting of the Emergency Response, Safety, and Ethics subcommittee, the group welcomed two new non-voting participants to give presentations. Dr. Kristin Speer is a co-founder and board member of the Psychedelic Pharmacists Association and Mikki Vogt is a therapist, practitioner, and member of the Psychedelic Public Policy Partnership along with Dr. Speer and Dr. Jon Treem.
Sara Gael, a non-voting participant and therapist in MAPS PBC’s clinical MDMA trials, gave a presentation on recommendations regarding video recordings of administration sessions. Ms. Gael expressed the view that video recordings are vulnerable to misuse and advocated for limiting a participant’s access to viewing the recordings but not permitting them to possess a copy under normal circumstances. Ms. Gael received pushback from subcommittee chair Dr. Brad Conner who questioned Ms. Gael’s assertion that practitioners have a right to privacy and confidentiality. When pressed on this issue, Ms. Gael could not point to where such a right existed, and conceded that practitioners in the mental health and medical fields have at best an expectation of confidentiality. When questioned further, Ms. Gael indicated the suggestions presented were derived from experiences in MAPS-sponsored clinical trials and that she had personally not been party to the decision making process for the procedures used in those trials. NMAB members Dr. Conner and Dr. Alisa Hannum drew comparisons to video recording rules in psychotherapy practice, acknowledging that patients have full rights to any recordings of their sessions. Rochelle Galey of the Behavior Health Administration indicated that the BHA has a similar policy of unrestricted patient access. The subcommittee considered additional concerns including certain spiritual opposition to video recording, whether such recordings would be HIPAA-protected, and the cost impacts of storing video recordings securely. As the committee contemplated what level of legal protection video recordings would be afforded, Assistant Attorney General Ashely Moller indicated that the language of the statute protects such recordings from state record requests by classifying them as medical data, however it does not clearly place video recordings within the protection of HIPAA. Discussion concluded with an acknowledgement that the state may need to implement a HIPAA-equivalent state law and the NMAB may need to differentiate video recordings of administration sessions from other recordings such as Healing Center security videos.
Next the subcommittee considered a set of recommendations, drafted by Dr. Bradley Conner, defining “Authorized Locations other than Healing Centers” where natural medicine services would be permitted. Under the initial draft, locations currently licensed to provide medical or mental health services would automatically qualify as authorized locations with an option to opt out – a big win for the accessibility of natural medicine. Facilitation in private residences would be permitted on a participant-by-participant basis, requiring a facilitator to submit an application for each residential facilitation – making the rule almost unworkable. After several members voiced concern over the burden and potential administrative delay in applying for each at-home facilitation individually, non-voting participant Mikki Vogt suggested adding a license endorsement or add-on that would allow the holder to conduct natural medicine services in residences. The suggestion was accepted and Dr. Conner will rewrite the recommendation to include a license with at-home care privileges, replacing the need to apply for each residential facilitation individually. Addressing the need to accommodate facilitation for hospice and end-of-life patients and acknowledging the federal restrictions on facilities receiving medicaid dollars, Dr. Jon Treem suggested a mobile license type to avoid complications related to hospice facilities disallowing federally scheduled substances on their premises. The specifics of such a license were not discussed in detail. Emily Messinger suggested that the subcommittee look into rules around aided dying, which is federally prohibited but allowed under Colorado law.
The subcommittee then received a presentation by Dr. Jon Treem on a client screening tool developed by the Psychedelic Public Policy Partnership (PPPP). The goal of the screening tool is to assist wellness-level facilitators in determining when it is necessary to refer to or collaborate with another facilitator or when natural medicine is not appropriate for a participant. Based on information regarding a participant’s general health situation, acute medical and mental conditions, and current medications or other potential pharmacological interactions, the screening tool will indicate one of four routes:
- Proceed without any additional steps
- Proceed with a safety plan developed by the facilitator
- Proceed with a medical safety plan developed in collaboration with a medical licensed facilitator
- Do not proceed
While the subcommittee appreciated the tool, Dr. Conner urged that, due to uncertainties around implementation, the best route forward would be to expand on the list of specific medical contraindications and provide that information to the subcommittee. He and Dr. Alisa Hannum will create a decision tree or logic-based electronic screening system that alleviates the need for a facilitator to make a judgment regarding participant safety. The PPPP will bring additional information to the January 10th meeting of the subcommittee. The details of this decision tree will greatly affect participant access and cost by determining when additional consultation with medical or mental health professionals is required.
Finally the subcommittee reviewed several remaining rules pulled from Oregon’s program by Dr. Josh Goodwin as potentially relevant to the work of the NMAB. Departing from Oregon, the subcommittee intends to recommend that facilitators be permitted to handle natural medicine and natural medicine products. While there was consensus around allowing facilitators to handle natural medicine for practical reasons, there is an unresolved wrinkle in how handling or administering schedule I substances may affect a facilitator’s other licenses. The main concern is that another regulatory body, such as the medical board or nursing board, may discipline a facilitator for handling natural medicine. This remains an open issue. However, it seems like creating flexibility permitting but not requiring a facilitator to possess and distribute natural medicine would alleviate these concerns.
Discussing an Oregon rule permitting participants to combine natural medicine with packaged food products, the subcommittee recognized a need to define what is “preparation” versus “production”. For example, does brewing a tea or making a peanut butter sandwich count as “production” and thus require a production license? Ean Seeb, a cannabis industry veteran, suggested that a facilitator should only be permitted to offer final prepared products to participants. Under this model, if a facilitator wanted to offer tea as a method of consumption, they would need to use a prepackaged tea product and would not be permitted to modify whole fruiting mushroom bodies into a tea. Rules prohibiting fresh foods seem unnecessarily restrictive at this point. Concerns could be alleviated by requiring healing centers that serve food to have the relevant local food establishment permits, which several members pointed out. The subcommittee will revisit this question as well as consider permissible routes of administration at the next meeting. Dr. Conner will draft definitions of “preparation” and “production”.
The next meeting is scheduled for January 10th, 2024 at 1pm MST.
The first agenda item in the December meeting of the Public Health & Health Equity subcommittee called for review of two specific recommendations that had been revised in the last subcommittee meeting. The first of these was a suggestion that the state, to the extent feasible without impacting license fees, include an equity assessment as part of the mandated annual report on the implementation of the Natural Medicine Health Act. The recommendation was passed as written unanimously.
The second recommendation, that the state partner with a 3rd party to allow payment of license fees over time, as soon as feasible, generated a significant discussion which ultimately led to a more abstract discussion about the goals and work of the equity subcommittee. Several members seemed unclear on the nature of the recommendation. Dr. Josh Goodwin was under the impression that a payment-over-time system would increase administrative overhead without providing a benefit to licensees. Commissioner Buxton-Andrade wondered if the recommendation would open licensees up to working with loan sharks. After clarifying that the purpose is to allow licensees to obtain a license up front and pay it off over time by partnering with a 3rd-party payment processor, the reality of payment vendors not wanting to work with federally illegal businesses set in. Several members suggested the recommendation be tabled and revisited after the launch of the program. Some members expressed sentiments that being unable to afford a license fee bodes ill for the likelihood of business success. Pushing back on this idea, Lundy reminded the subcommittee that licensee fees are likely to be high and that the purpose of the subcommittee is to reduce barriers to entry of which cost is likely going to be the largest. Lundy also pushed the group to be clear about what recommendations are relevant at the outset of the regulated program versus which can be implemented later. Lundy pushed for the idea that reducing the cost barrier should be a top priority. Billy Wynne supported Lundy’s position, feeling it acceptable for the equity subcommittee to lean into its charge of increasing equity in the program even if some suggestions it puts forth aren’t initially feasible. The subcommittee then revisited the idea of tiered license fees and once again ran into the practical limitation that the cash-fund nature of the program requires license fees to accurately reflect administration costs. Sensing that the payment-over-time recommendation is not practical at the outset, Chair Billy Wynne called for a vote on tabling the suggestion until year two. Brian Urankar of the Attorney General’s office advised that the subcommittee can make recommendations that may not be feasible and let the regulators make the final determination. With this shift in perspective the subcommittee voted to make the recommendation as written to the full NMAB.
After a brief break the subcommittee engaged in a higher level discussion of their process for making recommendations. Lundy expressed their confusion over why the subcommittee appears to be only considering a small handful of suggestions out of the dozens generated. This was accompanied by a deeper concern that the subcommittee has little to show in support of equity relative to the eight months of work they have done. Dr. Goodwin suggested that an alternate method of impacting equity is to weigh in on the recommendations of other subcommittees with the subcommittee’s perspective. At this point the subcommittee chose to diverge from the agenda, which called for consideration of three other specific recommendations, in favor of revisiting all suggestions generated by the subcommittee in the next meeting. Lundy will update the compiled equity suggestions list and incorporate new information from the last several months of NMAB work before the next meeting.
Turning to the larger list of consolidated draft NMAB recommendations, Dr. Goodwin opened discussion by relaying recommendations under consideration in other subcommittees which would limit at-home facilitation. The group broadly agreed that restrictions on facilitation may impact equity by reducing availability of care and concentrating market power in healing centers, which are likely to be expensive operations controlled by those with significant capital access. Mr. Urankar advised that it is within the subcommittee’s purview to make recommendations in conflict with other subcommittees. The ensuing discussion broadly encompassed the need for facilitator autonomy with two more specific areas. The first is the implicit statutory need for a facilitator to be associated in some way with a healing center in order to receive natural medicine. While facilitators receiving natural medicine directly from a cultivator or producer is not explicitly precluded by statute, it is also not clearly permitted. After discussion and input from Mr. Urankar, the subcommittee voted to approve a 2-part recommendation. If possible under current statute, the regulator should establish by rule that transfer of natural medicine to a facilitator by a cultivator or producer is permitted and, if not currently permissible, the legislature should clarify as much in statute.
The second issue related to facilitator autonomy is the ability to offer natural medicine services in private residences. Dr. Goodwin recapped concerns cropping up in other subcommittees related to chain of custody, facilitator safety, and circumvention of license requirements and fees. The subcommittee broadly agreed that facilitation in private residence is desirable in the interest of equity – and as clearly approved by voters in the Natural Medicine Health Act. While other subcommittees have recognized a need to allow facilitation outside of healing centers for end of life care, there has been an undercurrent of opposition to allowing a facilitator to operate in their own home. The subcommittee recognized that allowing a facilitator to operate in their own home is desirable because the facilitator has more control over safety issues, set and setting, and can offer group facilitation more feasibly in their own home. After clarifying that the statutory language of C.R.S. § 12-170-105 clearly contemplates facilitation in private residences, the subcommittee voted 4-1 to approve a recommendation that the state should interpret that section to permit administration of natural medicine in the private residence of both participants and facilitators. This is a huge step for accessibility and equity provided the board can implement rules to keep participants safe in private residences. Commissioner Buxton-Andrade voted against this recommendation due to what appeared to be concern over conflicts with local zoning laws.
The next meeting is set for January 11th, 2024 at 1pm MST. The subcommittee will review an updated list of equity suggestions and vote on them individually.
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.
December’s meeting of Products, Research, and Data began with DOR representative Allison Robinette walking through the subcommittee’s current draft recommendations in an effort to understand the intent behind them. Regarding testing lab accreditation, it was agreed that ISO 17025 is the appropriate standard and that microbials and solvents should be added to the testing panel. If a product fails a potency test the subcommittee will recommend re-labeling the failed product with the later, accurate potency results. The subcommittee engaged in a robust discussion around product types, weighing the risk to public safety of allowing new, untested products onto the market against potentially stifling innovation. Subcommittee chair Dr. Conner will draft a recommendation that initially permits orally administered products while allowing for additional methods of administration contingent upon evidence of safety.
The subcommittee then received a presentation from non-voting participant and guest Caleb King on proficiency testing. Proficiency testing broadly encompasses various methods for testing and validating a laboratory’s abilities. A common proficiency testing procedure involves a third-party “spiking” a “matrix” (sample) with the substance the test is designed to measure proficiency in. For example, a lab undergoing proficiency testing would receive a sample containing an amount of psilocybin known to the test producer but not the lab. The proficiency of the lab’s methodology for psilocybin testing is measured by how closely the lab’s results compare to the actual quantity in the sample. According to several scientists in the meeting, only one company currently produces a true proficiency test for psilocybin, meaning a test matrix that is representative of a psilocybin-containing mushroom. One other company produces a test in which a functional mushroom sample is spiked with psilocybin.
Several hurdles to implementing proficiency testing for psilocybin were identified including the lack of true psilocybin proficiency tests available on the market, dearth of ISO 17025-accredited labs in Colorado, and the inability of CDPHE to directly distribute samples of psilocybin due to restrictions related to the Department’s DEA license. Ms. Krug described a similar problem encountered by the department when cannabis was legalized. In the absence of true third-party proficiency tests, the department used round-robin testing. In this method, laboratories receive a sample with a concentration of the tested analyte determined by CDPHE. According to CDPHE representative Heather Krug, at least 10 laboratories should be involved in a round-robin test to achieve statistically robust results. Ideally those labs are ISO 17025-accredited, however through this process several labs gained ISO-17025 accreditation. As the cannabis industry matured, true third-party proficiency tests entered the market and CDPHE shifted proficiency testing to third-party testing. Based on input from CDPHE and DOR representatives, the subcommittee will make a general recommendation that the regulator establish proficiency testing, allowing DOR and CDPHE discretion in doing so.
The subcommittee then discussed the maximum dose allowable in an administration session. At the urging of Dr. Sue Sisley and concurrence of several other members, chair Dr. Conner will re-draft the recommendation to raise the limit to 50mg. This ceiling is in line with both Oregon and clinical trials currently underway at the University of Wisconsin.
Next the subcommittee received a presentation from Dr. Adie Rae Wilson-Poe regarding data collection in Oregon. According to Dr. Wilson-Poe, under SB 303, psilocybin service centers in Oregon must report demographic information including county of residence, reasons someone is seeking psilocybin services, number of clients served, total group sessions conducted, and number of times a client has received psilocybin services to the Oregon Health Authority. SB 303 does not, however, require OHA to provide any information back to service centers. To bridge this gap, Dr. Wilson-Poe and the state of Oregon are working with a team of researchers at Oregon Health and Science University in Portland on a project called the Oregon Psilocybin Evaluation Nexus (“OPEN”). Dr. Wilson-Poe claims that the goals of OPEN are to assist psilocybin service centers in complying with SB 303 and improve the overall quality of the Oregon Psilocybin Services program by providing useful information, such as client feedback, to service centers.
Dr. Wilson-Poe urged the subcommittee to design a data collection plan that harmonizes with Oregon’s requirements. The final regulatory interpretations of SB 303 were recently adopted by Oregon Health Authority, go into effect January 1st, 2025, allowing the board time to adopt similar rules.
Dr. Conner was particularly interested in how the data collected will be protected. Dr. Wilson-Poe shared that the OPEN researchers intend to apply for a federal certificate of confidentiality. According to Dr. Wilson-Poe this certificate protects research data to a higher degree than HIPAA, even protecting the data from being subpoenaed. Dr. Conner inquired about whether the state itself could hold such a certificate or if it would need to be held by the principal investigator of a research initiative. Dr. Wilson-Poe suggested that an academic public partnership between the state and a university system could solve any issues with the state holding a certificate of confidentiality. Under the framework used by OPEN, the researchers at OHSU hold the certificate of confidentiality.
Dr. Conner then inquired about consent procedures used by OPEN. According to Dr. Wilson-Poe, SB 303 allows clients to opt-out of data collection, however the extent of opt-out allowances will be determined in rulemaking.
When asked what OPEN plans to do if the certificate of confidentiality is denied, according to Dr. Wilson-Poe, OPEN would collect data anonymously and without any Protected Health Information (“PHI”). In this scenario, a longitudinal study, which inherently requires PHI to contact individuals over time, would be compartmentalized as a separate study, classified as research data, and eligible for a certificate of confidentiality. An important distinction for the board is whether participant data in Colorado is classified as medical data for the purposes of HIPAA protection, or classified as research data. Further, if the data is classified as research data, can a certificate of confidentiality be held by the state generally, or must a named researcher hold the certificate? Under Oregon’s framework, psilocybin services are explicitly not medical services and thus have no HIPAA protection. The exact legal status of participant data is less clear under Colorado law, which classifies participant data as medical data for the purposes of protecting it from open records requests but does not explicitly classify participant data as PHI for the purposes of HIPAA. Concluding that the many questions relating to data collection are unlikely to be resolved by the time the first round of rulemaking begins, Dr. Conner requested that the Attorney General’s office conduct an analysis on how participant data can be classified under Colorado law to inform the structure of the data collection program.
Before adjourning the subcommittee revisited the subject of outdoor cultivation at the prompting of Skippy Upton-Mesirow. The current status quo is a recommendation that outdoor cultivation be prohibited. The justification for this recommendation is a belief that prohibiting outdoor cultivation is the only way to ensure mushrooms sold in the regulated market are grown in a controlled manner. Mr. Upton-Mesirow advocated for allowing outdoor cultivation in order to be inclusive of spiritual practices and allow traditional and ceremonial cultivators access to the profit streams of the regulated market. The subcommittee discussed various implications of allowing outdoor cultivation including unwanted spread of mushroom spores, increased costs of regulating outdoor grow spaces, imposing rules on a traditional method of cultivation, and more stringent testing necessitated by outdoor cultivation. Considering the possibility of a license specific to outdoor cultivation, DOR representative Allison Robinette explained that DOR will be responsible for ensuring licensees comply with local time/place/manner restrictions and zoning ordinances, a task that may be more complicated (and costly) if outdoor cultivation is permitted. With several members expressing reservations towards an outright ban on outdoor cultivation, the subcommittee will revisit the topic in January. Dr. Conner has requested that non-voting participants with mycological experience be present if possible.
The next meeting is scheduled for January 17th at 1pm MST.
In December the Qualifications, Licensing, and Training subcommittee welcomed one new non-voting participant, Dr. Anita Kumar. Dr. Kumar is a psychiatrist practicing with Denver Wellness Associates.
The first discussion focused on education standards for facilitators. This lengthy discussion included updates to the current training requirements in the consolidated NMAB recommendations as well as a whitepaper submitted by the Psychedelic Public Policy Partnership (PPPP). Subcommittee members noted significant overlap between the current draft NMAB recommendations and those put forth by the PPPP. Members questioned suggestions of the PPPP framework such as the need for facilitators to be trained in the nuances of clinical study design, feeling that such education may be helpful for clinically trained facilitators but not necessary as a core competency of facilitation. Dr. Bradley Conner also questioned why the PPPP suggested exempting facilitators who complete 20 sessions in 2 years from continuing education requirements.
The subcommittee engaged in an expansive discussion on the allotment of hours given to certain training topics. Dr. Conner felt that hours assigned to ethics should be increased and should include “ethical decision making” as a topic. Several members also voiced support for including education on the basics of running a business, based on their experiences receiving requests for such training in other programs. Dr. Conner next suggested increasing training on social and cultural dynamics from 5 hours to at least 10, which received strong support amongst both NMAB members and non-voting participants. Dr. Hannum will revise the Ethics and Social/Cultural module hours to 10 each. Several members also felt that 5 hours of training in self-care was deficient. Legacy facilitator James Eshelman, the originator of the self-care training suggestion, pushed for 10-15 hours as a minimum. Fellow facilitator and training program operator Jimmy Nguyen echoed this sentiment, emphasizing the importance of robust facilitator training to prevent harm to participants and avoid issues across the state that may result from facilitators not being prepared for the realities of facilitation. The self-care discussion included topics such as when a facilitator needs to take time off to process a difficult experience, how to handle abuse from clients, and ethical considerations around stopping care.
Up next was the topic of physical touch training. Under the current training framework, touch is a component of several training modules. The subcommittee agreed that touch, being a critical component of facilitation, should be given its own module. East Asian Medicine doctor Matthew Kester noted the need for hands-on practice with touching participants to prevent awkward interactions that may be magnified in an altered state of consciousness. Dr. Conner will revise the curriculum to consolidate touch training into a new module as well as look for opportunities to streamline the curriculum broadly.
The subcommittee also considered the effects of all these modifications broadly. Lundy, ever vigilant about cost and equity, expressed concerns about adding hours and requirements that differ from Oregon. Dr. Conner placed the total training in the context of being roughly equivalent to 3 university courses. Members generally agreed that quality training for facilitators is the foundation of the entire natural medicine ecosystem and should not be skimped on. Dr. Shannon Hughes mentioned that Oregon may be revising their training requirements and could potentially bring them in line with Colorado, rather than Colorado attempting to fit too closely to Oregon.
After a break the subcommittee turned to the multifaceted issue of accelerated training, addressing three questions:
- What qualifications or credentials warrant accelerated training for Indigenous practitioners?
- What qualifications or credentials warrant accelerated training for non-Indigenous practitioners?
- Who will serve as practicum and consultation supervisors for the first crop of facilitators?
The subcommittee tackled question 3 first, which chair Dr. Hannum described as a nesting doll or chicken-and-egg problem. If the licensure requires practicum and consultation components completed under the supervision of a licensed facilitator, the state cannot license any facilitators without licensed facilitators. To solve this problem, Dr. Hannum suggested an additional license similar to the “Distinguished Scholar” license granted by the medical board to visiting physicians teaching in hospitals. Adding such a license would bring the total facilitator-type licenses up to 5 (Wellness, psychotherapy, medicine, trainee, and distinguished supervisor). Under a “Distinguished Supervisor” (working title) facilitator license, a sufficiently experienced facilitator would be granted a provisional license to facilitate for the purposes of providing hands-on training to facilitators in training. Recognizing the need for supervisors, the group praised this suggestion. Potential candidates for this new license may be underground practitioners in Colorado, experienced facilitators from other countries, or licensed Oregon facilitators. Several concerns were raised including who would carry the liability for the actions of the supervisor and their trainees, the potential for the distinguished supervisor license to operate as a backdoor to avoid the requirements of full licensure, and privacy concerns with asking underground practitioners to identify themselves to the government, and how to vet distinguished supervisors. If the corollary of the medical board is followed, a training program employing a distinguished teacher would assume liability for their actions. This segued into discussion of how training programs themselves, which will be employing supervising facilitators, will be accredited. Assistant Attorney General Ashely Moller explained that the state will accredit training schools in a yet-to-be-determined manner. Dr. Conner suggested following the model used by the BHA in accrediting addiction counseling programs. Under that framework, any entity from a university to a private individual can submit their training curriculum to the BHA and upon approval offer training courses in addiction counseling. New non-voting participant Dr. Anita Kumar raised the issue of a distinguished teacher exposing themselves to criminal liability by announcing themselves as an expert in federally illegal activity. This issue may be addressed in a future executive session. Mr. Nguyen raised the importance of mechanisms to weed out bad actors or people who should not become facilitators, a role that will fall to some degree on those supervising upcoming facilitators. There appears to be no magic bullet here but some combination of high qualifications, strong holistic application process, and oversight will be necessary. Another issue raised by Mr. Nguyen is the possibility of facilitators who wash out of training practicing in the personal use space. Again, no clear solution was visible but the subcommittee recognized the need for potential participants to be able to verify facilitator credentials. The final round of discussion on accelerated training focused on whether the accelerated training path should be offered to facilitators with experience using other substances such as MDMA or Ketamine. Diverging opinions were presented on this topic. On one hand, facilitating altered states of consciousness generally does offer some skills transferable to natural medicine facilitation. On the other hand, psilocybin experiences have the potential to be more difficult, longer in duration, and have specific medical implications that experience with ketamine or MDMA do not provide. This question remains open. As next steps, Dr. Hannum will draft requirements for a “Distinguished Teacher” license
The final agenda item was to review the current draft recommendations regarding facilitator licensure. Skippy Upton-Mesirow voiced the opinion that there should be a clear delineation of rural or frontier areas for the purposes of allowing virtual completion of the practicum and consultation components. This led to a vigorous debate about how much practicum experience can or should be able to be completed virtually. While NMAB members and non-voting participant unanimously agreed that direct, in-person experience with natural medicine is essential there was disagreement on what percentage of the 40-hour practicum requirement must be completed in-person. Lundy advocated for a flexible approach to accommodate geographic and demographically constrained people. In their view, requiring 40 hours of supervised practicum in-person will lock out those in rural areas or those who have time restrictions such as single mothers. Conversely, several actual facilitators on the call were quite averse to the idea that virtual experience can substitute for in-person experience and advocated for at least 75% of the practicum hours to be in-person. The subcommittee did not arrive at a specific solution but appears to be poised to recommend that a to-be-determined percentage of the practicum experience be in-person, allowing training programs to determine the exact practicum structure through weekend intensives or traveling supervisors.
The next meeting is scheduled for January 18th, 2023 at 9am MST.
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