Colorado Psychedelics Program: Natural Medicine Advisory Bulletin 14

Having completed the initial rulemaking push in July, Colorado regulators are putting the finishing touches on the state’s regulated Natural Medicine program by fine-tuning rules and setting fees. Since Bulletin 13, The Department of Revenue’s Natural Medicine Division (“the Division”), has released proposed fees for Natural Medicine Businesses. The Department of Regulatory Agencies’ Office of Natural Medicine Licensure (“the Office”) has recently published proposed revisions to rules related to facilitator licensing and training. Simultaneously, the Natural Medicine Advisory Board, its subcommittees, and the Federally Recognized American Tribes and Indigenous Community Working Group continue to grapple with remaining issues, old and new. In this Bulletin, we first look at big-picture questions such as fees and rule changes. Then, we’ll look at what each group has been working on since Bulletin 13. For a high-level summary of the rule framework as currently adopted, see Bulletin 13.5.

In this Issue

• Upcoming Public Engagement Opportunities
  • Licensing and Application Fees
  • Rule Changes: Facilitator Licensing and Training
  • Meeting Recaps
    • Rulemaking Hearings
    • Federally Recognized Tribes and Indigenous Community Working Group
    • Forms Subcommittee

Upcoming Public Engagement Opportunities

Are you considering applying for a Healing Center, Cultivation, Manufacturing, or Testing Facility license? The Division of Natural Medicine would like to hear from you in their Participant Survey.

Licensing and Application Fees

The looming question for Colorado’s program is whether it will be economically viable. Significantly bearing on the answer are licensing costs for businesses. Until August, the Department of Revenue’s Natural Medicine Division (“the Division”), which oversees Natural Medicine Businesses, had delayed setting fees until the full scope of its rules, and thus the cost of regulatory oversight, was solidified.

The Division’s initial fee structure, released on August 15th, proposed a “phased approach” of increasing fees over three years. According to the Division, this strategy is intended to encourage early adoption by essentially subsidizing fees in the first year at the cost of higher fees down the road. During a sparsely-attended initial stakeholder engagement meeting on August 28th, a handful of commenters expressed reservations at the proposed structure, taking issue with both the high overall cost of licenses as well as the confusing fee increases. Commenters questioned the practicality of setting fees so far out, given the uncertainty accompanying such a new market. As several speakers pointed out, fees totaling over $30,000 over three years in some instances may have the effect of discouraging participation, undermining the intent of the phased approach.

Ultimately, the initial proposed fee structure remained unchanged at a final hearing on September 18th. This time, however, the Division received substantial pushback during public comment, as well as an influx of written comments shortly before the final hearing, also opposing the proposed fees. In response to this feedback, the Division elected to continue the rulemaking proceeding until October 21st, allowing more time to incorporate feedback. In addition to the concerns expressed in the August stakeholder meeting, members of the public questioned whether fees should be significantly higher than more complex industries, such as hospitals, as well as seemingly random fee increases. Under the initial proposal, fee increases across licenses and years range from 29% to 150%, with no discernible logic.

The Division’s estimated program costs and revenue generation were another point of contention. As a cash-funded program, the Division is required by law to cover its operational costs exclusively through fee collection. The Division estimates a $1.7 million dollar annual budget need, including nine full-time employees. While Division officials were quick to point out the significant decrease from the 19 full-time employees estimated in the SB23-290 fiscal note, some members of the public thought that the estimate was high. If the market sees 5,000 administration sessions in the first year (a reasonable estimate based on Oregon’s numbers), the Division’s estimated budget would translate to hundreds of dollars in fees per session needed just to cover the Division’s operations. Moreover, regulatory fees required by other agencies, as well as direct and indirect compliance costs, could drive that figure even higher. To set fees sufficient to meet this budgetary need, the Division must estimate the number of licenses it will issue. According to the Division, license projections are based on responses to their market participation survey. While it is certainly no easy task to essentially guess what a non-existent market will look like a year or two down the road, many in the public have questioned the wisdom of setting fees so far into the future based on a single survey.

The Micro-Healing Center license proved to be of particular interest and concern to the public. This license, unique to Colorado, is the product of significant public collaboration and Colorado’s express allowance for mental health services to be provided in conjunction with Natural Medicine Services. Broadly speaking, the Micro-Healing Center license is intended to allow mental health professionals to provide Natural Medicine Services within their existing clinical practices, for a low volume of clients. This is a powerful and innovative feature of Colorado’s program, increasing the access to Natural Medicine for populations that could most benefit from support from qualified individuals. Under the Division’s initial proposal, a therapist seeking to incorporate regulated Natural Medicine Services into their existing practice would need to pay $12,000 in business fees by the third year, in addition to occupational fees for their Clinical Facilitator license. As many members of the public attested, including several prospective therapist-facilitators, the high cost all but guarantees that the Micro-Healing Center would be out of reach. While opinions differ, it is not uncommon to hear that the cost of services in Oregon is prohibitively high for many people. Colorado has a unique opportunity to ensure equitable access with the Micro-Healing Center license, but the license itself must be accessible first.

On October 14th, the Division released an updated fee schedule, retaining the phased approach, while adjusting fees for certain licenses. Notably, fees for both Micro and standard Healing Centers are decreased in the new proposal. During the final hearing on revised fees on October 21, 2024, several members of the public thanked the Division for the changes, while reiterating a broad desire for lower fees, specifically regarding Micro-Healing Centers.

Facilitator License Fees

The Department of Regulatory Agencies’ Office of Natural Medicine Licensure (“the Office”) has not formally proposed fees for Facilitators or Clinical Facilitators. In a recent meeting with the NMAB, the program director stated that the Office is anticipating fees to be lower than initial projections of $3,000-$5,000, but did not provide a concrete estimate.

Rule Changes: Facilitator Licensing and Training

On September 12th, the Office of Natural Medicine Licensure released 37 pages of proposed changes to facilitator licensing and training rules. While many of these changes are minor changes in organization, clarification, and grammar, they also include some substantial changes regarding supervised practice, consultation, and standards of practice. Since then, feedback from the Board, as well as public stakeholders, has led to further revisions. Below, we’ve summarized the latest proposed changes as of October 17, 2024. It’s important to note that further changes are possible until November 16th.

Supervised Practice Requirements

Current rules related to supervised practice, or “practicum,” have caused some confusion since initially adopted, especially for aspiring facilitators and training programs. Under proposed changes, the “alternative practicum,” which permits certain substitutes for experience with natural medicine, is sharply limited. Additionally, proposed rules now prescribe a fairly rigid distribution of hours, intended to ensure students receive a balance of experience necessary to practice facilitation.

Distribution and Timing of Practicum Hours

The latest proposed rules provide a detailed prescription of the 40 required practicum hours. Under the proposed changes, 30 of 40 total practicum hours must consist of in-person experience in administration sessions, either as a participant, observer, or co-facilitator. Of those 30 hours, a minimum of 10 must be in the role of co-facilitator. The remaining 20 hours may be additional co-facilitation hours, or in the role of a participant experiencing natural medicine, or as an observer of an administration session.

Non-administration hours, comprising 10 of 40 total practicum hours, may be virtual or in-person. These hours may be a mix of preparation, integration, and consultation, however a minimum of three hours each in preparation and integration sessions is required.

Additionally, up to 10 practicum hours may now be completed concurrently with didactic training, provided the student has completed at least 50% of the training program’s didactic education hours. Previously, practicum hours could only be earned following completion of all didactic training and issuance of a Training License.

Practicum Sites and Supervisors

Proposed rules now require that training programs inform the Office of practicum locations and dates. During a recent meeting of the Combined Subcommittee, Board members recommended clearly allowing practicum to take place at any location where Natural Medicine Services may be provided. Current rules appear to require practicum to take place at licensed Healing Centers, severely limiting potential locations and preventing any facilitator training until the Division of Natural Medicine begins licensing Healing Centers, which is not anticipated until January 1, 2025.

Consultation

The third requirement for full licensure, consultation, has been significantly modified in the proposed changes. Under current rules, facilitators must engage in 50 hours of consultation over a 6-month period with “an individual experienced in the provision of natural medicine services.” Proposed changes decrease the hour requirement from 50 to 40, as well as extend the completion window to two years, aligning the consultation period with the duration of a Training License.

Proposed rules also define “Consultant” as “an individual who is licensed as a natural medicine facilitator utilizing psilocybin with one (1) year of experience facilitating natural medicine services, regardless of whether the experience was licensed or not. An individual who in the last five years, has two hundred hours of experience facilitating natural medicine services using psilocybin, but does not hold licensure anywhere, may also serve as a consultant.”

This definition could narrow the pool of individuals that may serve as consultants, potentially creating a bottleneck if the rule is interpreted to mean the consultant must have experience in Colorado’s regulatory framework.

Standards of Practice

Exceptions to Confidentiality of Participant Records

Proposed changes to confidentiality rules expand the list of circumstances under which a facilitator may disclose participant information that is otherwise required to be kept confidential to include:

• Court orders
• Clear and present danger to the participant or others
• Payment processing and debt collection
• Reasonable knowledge of neglect or abuse of a child, elder, or at-risk adult
• Reasonable belief that the participant will operate a motor vehicle
• Reporting unprofessional conduct by another facilitator

Informed Consent Regarding Limits of Confidentiality

Proposed changes would require facilitators who are subject to mandatory reporting laws or have professional relationships with mandatory reporters to disclose these limits of confidentiality to participants.

Preparation and Administration Sessions

Proposed changes would require that Preparation Sessions occur no less than 24 hours, but not more than 60 days, before an Administration Session. Additionally, rules seek to establish a limit on the amount of time a facilitator can spend in Administration Sessions in a 24-hour period but do not specify a limit.

Meeting Recaps

Combined Subcommittee: August

During a brief meeting in August, the Combined Subcommittee discussed documentation and methods of verification that the Office of Natural Medicine Licensure could use to verify a legacy healer’s qualifications under accelerated licensure rules. Ultimately, the subcommittee recommended:

1. All accelerated licensure applicants must pass a jurisprudence exam;
2. As proof of experience, documentation that includes 3rd-party confirmation, such as affidavits from teachers or other verifiable information, would be accepted and verified by the Office;
3. If verifiable information is not available, the Indigenous and Religious Use and Outreach subcommittee will be convened to evaluate an applicant and make a recommendation to the Director of the Office regarding the applicant.

Next, the subcommittee turned to the topic of forms. Rules require facilitators to document certain information about the Natural Medicine Services they provide, such as informed consent, safety screening, and administration session information. However, rules do not specify how information is to be collected or maintained. To avoid added complexity for facilitators, the combined subcommittee recommended that the Office develop a set of forms that will meet the requirements of the rules. While facilitators may elect to use their own forms or documentation system, by using Office-approved forms, facilitators can ensure compliance with recordkeeping rules. The meeting concluded with the subcommittee recommending the establishment of a separate subcommittee to focus specifically on the technical task of developing forms.

Full Natural Medicine Advisory Board: August

During brief opening updates, DORA Program Director Lorey Bratten shared that, as of the meeting, eight facilitator training programs had applied for approval, most of which had been granted.

Moving into new business, the Board discussed its upcoming annual report, which is required by statute. Board Chair Lundy shared an outline of the report, which the Board will complete in conjunction with the Office. According to Director Bratten, the Board has made several hundred recommendations, over 200 of which have been incorporated into rules. A representative from the Attorney General’s office informed the Board that the report is an opportunity for the Board to make legislative recommendations to the General Assembly.

Next, the Board discussed a complete version of the Facilitator Ethical Code of Conduct, to be used by facilitator training programs when teaching facilitator ethics. Although the Board previously adopted a complete ethical code, only enforceable parts of the code were incorporated into rules, and the remaining portions are not found in any official documents. Following a discussion about the size and unwieldiness of the complete code, the Board requested an additional version with references to enforceable rules, hoping to reduce redundancy and increase clarity.

August’s meeting closed with the full Board approving the creation of a forms-specific subcommittee. The subcommittee will consist of:

• Bradley Conner, PhD, a licensed psychologist
• Alisa Hannum, PhD, a clinical psychologist
• Sue Sisley, MD, a clinical researcher
• Clarissa Pinkola-Estés, PhD, a clinical psychologist
• Skippy Upton-Mesirow

***

Combined Subcommittee: September

As requested by the Board in August, Office of Natural Medicine Licensure officials presented a streamlined version of the Facilitator Ethical Code of Conduct. At the suggestion of subcommittee chair Dr. Brad Conner, Program Director Lorey Bratten will create a companion to the ethical code containing the full text of relevant ethical rules.

Next, the subcommittee discussed proposed changes to facilitator licensing and rules. Under new rules, facilitators are required to disclose whether they are a mandated reporter, or if they professionally interact with one in such a way that participant confidentiality is limited. Additionally, proposed rules provide discretionary exceptions to the general rule of protecting participant confidentiality for situations where the facilitator receives information indicating imminent harm, child abuse, and neglect. Regulators described these rules as allowing discretionary reporting. Separately, Colorado law defines certain professionals, including many health professionals, as mandatory reporters. Recognizing that subtle distinctions in reporting obligations may cause confusion for participants, the subcommittee identified a need to clearly explain the limits of confidentiality during the informed consent process. This would include whether a facilitator was otherwise a mandatory reporter if a facilitator works professionally with other facilitators, that may be mandatory reporters and exceptions to confidentiality rules under which a facilitator may break confidentiality. Dr. Sue Sisley pointed out that information received while under the influence of Natural Medicine may not be reliable, and asked if information received during an administration session be exempted. According to Office staff, the statutory requirement of mandatory reporters is a “reasonable belief,” regardless of the circumstances under which information is received.

Discussing changes to definitions, the subcommittee first discussed the new definition of “consultant.” Dr. Sophia Chavez encouraged regulators to proactively engage with Indigenous communities and legacy healers about becoming consultants. The subcommittee requested an update on how the state has been engaging with these communities, which they understood to have been occurring.

Subcommittee members were surprised to learn that, under the current rules, an individual could be licensed as a facilitator without ever practicing facilitation. Newly proposed rules correct that particular concern; however, someone could still be licensed without experience conducting preparation and integration sessions. This issue was corrected in an update presented to the full NMAB the following week but has not been reflected in officially noticed proposed changes.

Regarding changes to consultation requirements, Dr. Conner pushed back on a new rule requiring facilitators to engage in ongoing consultation, in addition to continuing education. Dr. Sophia Chavez concurred, and the subcommittee unanimously voted to recommend striking the ongoing consultation requirement.

Regarding when preparation sessions can occur relative to an administration session, the subcommittee recommended that they be conducted no more than 60 days and no less than 24 hours prior to an administration session. A related rule that would set limits on how many hours or sessions a facilitator may provide facilitation services in close succession was tabled for future discussion.

Natural Medicine Advisory Board: September

September’s meeting of the full Natural Medicine Advisory Board included a number of administrative affairs, such as announcing the resignation of Dr. Joshua Goodwin, approving the Board’s 2025 meeting calendar, and amending the Board’s bylaws to clarify that future appointments to the Board do not require confirmation by the Colorado Senate. The Board will vote on a new chair and vice-chair in November 2024. The training program-focused version of the Facilitator Ethical Code of Conduct, approved by the subcommittee a week prior, was presented to the Board and accepted.

Discussing proposed changes to practicum requirements, Skippy Upton-Mesirow expressed concern that the current distribution of hours would conflict with a common supervised practice model. Under the “triad” model discussed, students spend equal time in the roles of observer, participant, and co-facilitator. According to several members of the Board, this model is commonplace, with practicums often taking the form of a weekend intensive. Dr. Sue Sisley pointed out that in Oregon, observation is the only form of permitted supervised practice, which may be an issue if Colorado rules require that students serve in the role of facilitator. In response, Program Director Lorey Bratten clarified that the proposed rules are not intended to prohibit practicum from taking place in Oregon, or even internationally. When questioned about the requirement that practicum supervisors be “affiliated” with a training program, staff indicated that a formal relationship, such as a contract, would be sufficient. Dr. Sisley also requested that rules be updated to be more clear about locations other than Healing Centers that can serve as practicum sites.

The final discussion topic for September was a recommendation drafted by Dr. Sue Sisley. The recommendation urged the Colorado Department of Public Health and Environment to begin the process of engaging a vendor in the creation of a participant outcome database. Further, the recommendation would direct the Department of Revenue to engage the General Assembly in passing emergency legislation permitting outside funding for the project. Measuring and reporting on the efficacy of Natural Medicine Services is one of the longest-running questions for the Board, and has been mired in what some feel is unnecessary red tape. In Dr. Sisley’s view, the state’s statutory directive to report on “behavioral health impacts” necessarily includes participant outcomes. Board members Dr. Brad Conner and Dr. Alisa Hannum similarly felt that post-administration outcome data is necessary to inform best practices such as dosing, as well as appropriate standards of care. State officials, however, have taken a different stance. According to the Department of Revenue’s Natural Medicine Division, the statutory mandate regarding behavioral health impacts extends only to requesting available data from other state agencies. While the statute does require the proactive collection of some data, the collection mandate does not include participant outcomes. Given the cash-fund nature of the program, state agencies are reluctant to undertake the creation of a participant outcome database, which some Board members have estimated to cost $1 million in the first year.

One solution put forward would have the state seek outside funding, such as charitable donations, to initially fund the creation and maintenance of the database. However, for a state agency to accept private funding, express statutory authorization is required. Again, the Board seemed frustrated by the machinations of the government. Any legislative change authorizing private funding would require a bill sponsor in the Colorado General Assembly. Board members are prohibited from individually communicating with legislators, and the collective Board’s only direct channel of communication with the General Assembly is through its annual report. As a last resort, Dr. Sisley implored Division officials to utilize its existing government relations resources to identify a sponsor for an emergency bill in January. Frustratingly, Division officials declined to do so, citing vaguely a desire to adhere to the Department of Revenue’s policies.

Despite these roadblocks, the Board voted to unanimously approve Dr. Sisley’s recommendation, with members emphasizing the unique, first-in-the-world opportunity to collect robust data on the efficacy of Natural Medicine. The recommendation will appear as the top priority in the annual report to the General Assembly in early 2025.

Rulemaking Hearings

Although the bulk of the rules comprising the regulatory framework of Colorado’s regulated Natural Medicine program have been adopted, a handful of subjects remain to be finalized. 

DOR Fee Setting Stakeholder Meeting: August 28

During an initial stakeholder engagement meeting, members of the public expressed concerns about the Division’s choice to set fees three years out and the overall costs for licenses. No changes were made before the final hearing on September 17th.

DOR Fee Final Hearing: September 17

At the final hearing, public stakeholders again urged the Division to reconsider its approach to fees. Speakers raised concerns about equity and access stemming from high fees, and the potential chilling effect that raising fees over three years could have on participation. In response to these comments, as well as written comments submitted in the days prior to the hearing, the Department elected to continue the fee rulemaking until October 21st.

DORA Facilitator Rule Changes: September 25

During an initial stakeholder meeting regarding proposed changes to facilitator licensing and training rules, members of the public primarily expressed concerns with consultation and practicum requirements. Specifically, commenters were concerned that requiring consultants to have 200 documented hours of natural medicine experience would make the program unworkable. Solutions proposed included allowing ketamine and MDMA-assisted therapy hours to be counted and delaying the implementation of the rule for a year. Several commenters also urged the Office to extend the consultation window beyond six months.

Proposed practicum changes also received significant feedback, particularly around where practicum can occur, alternative practicum formats, and the allocation of hours. Commenters frequently requested that the Office clearly define “authorized locations” for practicum sites and allow practicum sites in Oregon.

Additional suggestions included expanding allowable supportive touch, adjusting dosing rules to align with Oregon, and increasing consistency across rules.

Federally Recognized Tribes and Indigenous Community Working Group

During August’s meeting, the Federally Recognized Tribes and Indigenous Community Working Group received a presentation by Henrique Fernandes Antunes, a Brazilian anthropologist who studies ayahuasca. Mr. Antunes described the history of ayahuasca use, including the differences between Indigenous use and more modern ayahuasca churches, such as the Santo Daime religion.

Continuing to work through its statutory mandate, the group discussed the fourth and third of four topics listed in the statute: “Any conservation issues associated with the legalization and regulation of Natural Medicine or Natural Medicine Products, Including the potential for further depletion of Peyote due to Peyote being a source of Mescaline.”

Several members of the group expressed concerns that Colorado’s program will increase illegal peyote poaching, both directly through regulated use and indirectly through personal use decriminalization. Other members wanted to understand if the Natural Medicine Health Act modified the legal status of cultivated peyote in Colorado, as well as how the state’s obligations to enforce existing and new laws have shifted, but did not receive clear answers to their questions. One member raised possible environmental concerns such as overharvest and soil impacts from increased mushroom foraging. Broadly, the group felt that more effort should be put into reciprocity programs, conservation efforts, and cultural education.

During September’s meeting, the Working Group revisited conservation issues. Dr. Santiago Geurra suggested a seed-to-sale tracking method similar to that used in cannabis as a potential way to discourage illegal poaching and importation of natural medicines to Colorado.  Other topics discussed included:

• Incorporating traditional knowledge into the patent system
• Overharvesting of wild natural medicine
• Honoring Indigenous protocols and frameworks
• Impacts of regulation and decriminalization on Indigenous groups and sacred places
• Reaffirming the American Indian Religious Freedom Restoration Act
• Enforcing existing peyote laws

Finally, the group discussed the fourth and final statutory topic: “Best Practices and open communication to build trust and understanding between the federally recognized Tribes and Indigenous people and communities, the board, the division, the state licensing authority, and law enforcement agencies for the purpose of avoiding unnecessary burdens and criminalization of traditional, Tribal, and Indigenous uses of Natural Medicine.” 

The views of group members diverged on this topic, with one member expressing opposition to decriminalization or regulation of mescaline, and another opposing what they perceive as a medical model. Other members provided concrete recommendations on how the state can work effectively with Indigenous groups in the realm of natural medicine, which will be provided to the Board and state regulators in a report in early 2025.

Forms Subcommittee

Since its creation in August, the Forms subcommittee has met twice in September. During an initial meeting on September 5th, the subcommittee mapped out its task by identifying specific documentation required by statute and rule, strategies to streamline documentation, and potential approaches to measuring and reporting on outcomes. A second meeting on September 12th involved a nuanced discussion on the wording of specific forms and how to best present information to participants. A third meeting to approve and finalize the remaining forms is tentatively scheduled for October 31st from 12-2 p.m. MT. Following a final review, the subcommittee will test-run the form battery for length and burden, intending to recommend a final set of forms to the Board in the November meeting.