You are currently viewing Natural Medicine Advisory Bulletin 15: A Duplicitous December

Natural Medicine Advisory Bulletin 15: A Duplicitous December

Written by the Vicente LLP team as part of our Colorado Natural Medicine Health Act Tracker.

Note: This Natural Medicine Advisory Bulletin is written by Vicente LLP, and does not necessarily reflect the views of Psychedelic Alpha.

As of January 1st, 2025, Colorado’s Regulated Natural Medicine Program is open for business! 

After nearly two years of planning and hundreds (thousands?) of hours of board, subcommittee, and stakeholder meetings, applications for facilitators are live at the the Department of Regulatory Agencies’ (DORA) Office of Natural Medicine, and for Natural Medicine Businesses at the Department of Revenue’s (DOR) Natural Medicine Division.

This is a monumental moment for the state of Colorado, as well as the broader psychedelic movement, and we want to first thank the Board, the staff of DORA and DOR, the Colorado Department of Law, and each individual stakeholder that has contributed to building a program that provides safe and equitable access to the natural medicine we all believe in.

Now that applications are open, DORA has published the following guides to assist future facilitators in navigating the licensing framework:

Additional guidance is available for Natural Medicine Businesses on Advertising and an FAQ on Local Government Approval.

However, despite the agency doing its best to provide guidance to future applicants, a few significant questions still remain unanswered, namely:

  • Will administration sessions be permitted in private residences or non-licensed health-care facilities?
  • Will the rules provide a viable option for microdosing, like Oregon?

While rules have generally been trending in a positive direction, with regulators responding to stakeholder feedback and adjusting rules accordingly, a noticeable shift in tenor has taken place during the final months of 2024 by DORA. The agency made substantial changes to rules in the eleventh hour, blatantly disregarding public feedback and input from the Natural Medicine Advisory Board (NMAB).

In this Bulletin, we examine the remaining open questions for the program, as well as several ongoing controversies, the most significant being the questions of at-home facilitation and microdosing.

An initial stakeholder meeting on rules related to at-home facilitation and microdosing is scheduled for January 6th at 1:30 p.m. MST. The final hearing will be held on January 14th at 12 p.m. MST.

If you believe access to Natural Medicine should not be limited to Healing Centers, please attend a hearing or submit written comments to dora_dpo_rulemaking@state.co.us

In this Issue
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    Licensing Fees

    One of the fundamental questions for anyone interested in participating in Colorado’s program is how much it will cost. Thankfully, the longstanding question of facilitator licensing costs has finally been answered, with DORA announcing fees that are significantly lower than many anticipated.

    According to a recent email from DORA, annual fees for various types of facilitation licenses are as follows:

    • Facilitator in Training (NMIT): $420
    • Facilitator (NMF): $840
    • Clinical Facilitator (NMCF): $970
    • Distinguished Educator (NMDE): $1120

    Regarding fees for Natural Medicine Businesses,1 the Natural Medicine Division’s revised fee schedule was officially adopted on October 25th, following significant pushback on its initial proposal. While the final fees represent an improvement over the Division’s initial proposal, many members of the public wish the fees were lower and remain confused by the ramp up approach. However, we remain hopeful that if enough people apply for licensure the fees will not ramp up in future years.

    Changes to Facilitator Licensing and Training Rules

    Despite finalizing the rules over the last 18 months, DORA decided to make a substantial last-minute change to where natural medicine services can take place.

    The original rules, which became official in July, permitted natural medicine services in a participant’s home without restrictions. At the last minute, and without notice, DORA quietly gutted the rule by limiting at-home facilitation to only individuals currently receiving palliative care. This change, just days before the final scheduled hearing of the year, could effectively prohibit at-home facilitation for many who need it. Adding to the controversy, state officials made blatantly false and misleading statements to the public during the final hearing on these rule changes, which were originally billed as simple language cleanups.2

    The option to receive Natural Medicine outside the confines of Healing Centers, specifically in private residences, has been expected in Colorado’s Natural Medicine program since voters approved Proposition 122, which expressly included it.3 Both the NMAB and public stakeholders overwhelmingly supported this option, celebrating increased access to Natural Medicine, both physically and financially. Allowing administration in private residences is crucial to ensure equity and access to Natural Medicine Services for populations such as rural communities far from a Healing Center, home-bound individuals who cannot easily travel, and those who cannot afford the anticipated price tag of administration at Healing Centers.

    With facilitation-related rules having been finalized by July 2024, most believed the question of at-home facilitation was settled. However, on September 12th, the agency announced an additional rulemaking, proposing changes to some existing rules. This rulemaking was characterized as a “cleanup,” allegedly to streamline and clarify certain rules. The proposed changes received significant feedback from public stakeholders and the NMAB throughout September and October, through proper notice, official rulemaking proceedings, and stakeholder engagement. The permanent hearing on these changes was scheduled for November 19th. Then, in a move that shocked many stakeholders, DORA made substantial changes to the rules on the evening of Friday, November 15th, just days before the scheduled final hearing. In addition to potentially violating Colorado administrative laws requiring proper notice to the public of proposed changes, this move undermines public trust in the rulemaking process.

    Under DORA’s proposed changes, at-home facilitation would only be available to individuals currently receiving palliative care. Additionally, only Healing Center-affiliated facilitators may provide at-home facilitation services under the changes. The specific change that elicited outcry from nearly every commenter at the hearing reads as follows:

    6.18 Additional Requirements for Administration Sessions Outside of a Healing Center

    A facilitator who is employed by, contracted with, or holds a healing center license may facilitate an administration session in a location other than a healing center in accordance with these rules if they are facilitating for a participant requiring palliative care.4

    Seemingly in response to the overwhelming public pushback to the changes, DORA reversed course, quietly removing the controversial changes before submitting the remaining cleanup changes for the final steps of the process. Then, on December 13th, the Office published yet another rulemaking notice, this time focusing specifically on rules related to at-home facilitation and microdosing – which once again included the same problematic restrictions. We applaud DORA for going through a more inclusive process to address this issue. However, the substance of their proposed policy change restricting at-home care is still incredibly problematic.

    Nonetheless, the story doesn’t end there. In what some may perceive to be a post hoc attempt to justify the agency’s distaste for at-home facilitation, at the December 20th meeting of the NMAB, guest speaker Dr. Anita Kumar was invited to provide her opinion on at-home facilitation. No one was invited to provide a counter opinion.

    Dr. Kumar, who identified herself as a psychiatrist and “staunch advocate of Natural Medicine” was of the opinion that at-home facilitation should be limited to palliative care patients. Her brief presentation began with a personal anecdote, in which she shared her recent experience of using natural medicine in a private residence with a group of her family and peers. This experience, it was implied, led to her “realizing the need for an impeccable container.” Without providing any further background or supporting evidence, Dr. Kumar stated simply:

     “The bottom line is . . . we all want safety, and I feel like the safety is going to come from the client’s confidence that their experience will be a positive one. And that comes from having a positive mindset in a safe setting… I’m recommending to this group that the general population journey in Healing Centers, and the exception be palliative care and end of life.”

     

    Dr. Kumar did, however, suggest that expanding residential access may be acceptable to her in the future, after more data has been collected.

    Responding to Board questions regarding her own experiences with at-home facilitation, Dr. Kumar’s answers essentially amounted to more anecdotes and opinions. When asked about issues she had experienced regarding at-home facilitation, Dr. Kumar identified only the “looseness of the container” in one of her personal experiences as a participant. She also shared an experience in an Oregon Service Center, stating that [the structure of the service center] “gave me what I needed.” To be sure, many individuals would similarly benefit from a structured environment. However, generalizing the conditions that would be best for the larger population based on one’s limited personal experiences is, at best, a questionable way to determine policies affecting countless unique individuals, each with unique needs and preferences.

    Responding to additional questions from the Board, Dr. Kumar shared the following:

    • She has personally received Natural Medicine in a residential setting, without significant issue;
    • She has provided group facilitation in a private setting, without significant issue;5
    • She has not provided 1-on-1 facilitation services as a facilitator personally.

    Several members of the Board pushed back on Dr. Kumar’s position. Dr. Sophia Chavez shared that in the curandero and indigenous-rooted communities of which she is part, at-home facilitation is both a common occurrence and considered quite safe. Dr. Sue Sisley pointed out that, once established, corporate Healing Centers will be economically incentivized to oppose at-home facilitation. Dr. Sisley also pointed out the reality that underground at-home facilitation is already commonly occurring and has been for quite some time. Skippy Upton-Mesirow noted that many underground facilitators, who are already reluctant to join the regulated market, will be further pushed away by this prohibition. Dr. Alisa Hannum, a clinical psychologist, expressed strong support for expanding at-home facilitation access beyond palliative care.

    Following the lengthy discussion, Dr. Sisley proposed a motion that would permit at-home facilitation in the following circumstances: 

    • If a participant is homebound, has a physical disability, or is receiving palliative care;
    • If recommended by the participant’s treating provider;
    • For Indigenous purposes;
    • If the participant lives more than 50 miles from a Healing Center;
    • Financial hardship.

    Unfortunately, before voting on Dr. Sisley’s motion, the Board entered a closed-door Executive Session that consumed the remainder of the meeting time. Upon returning, the motion was tabled, leaving this significant issue unresolved for at least another month.

    Viewed holistically, the last-minute changes, unprecedented interagency support, and a single guest “expert” with limited at-home facilitation experience, have left some feeling as though DORA is attempting a post hoc justification of an incredibly unpopular change to at-home facilitation.

    Emails obtained through a CORA request show that the Office of Natural Medicine Licensure approached Dr. Kumar to speak about restricting residential administration on December 3rd, after the agency received significant pushback in the November 19th hearing. In those emails, during which a phone call was scheduled with Dr. Kumar, the Director clearly stated the Office’s position is to only allow administration by facilitators that are associated with Healing Centers. Unfortunately, the substance of the phone conversation is not available to the public.

    Rule Changes: Supervised Practice Requirements

    While certainly less controversial than at-home facilitation, Supervised Practice (“practicum”) requirements have seen more revisions than nearly any rule. Although the final version put forth for November’s permanent hearing is less prescriptive than prior versions, several individuals speaking on behalf of facilitator training programs felt the rules are still burdensome.

    Specifically, representatives from training programs felt that more flexibility is needed around the 30 hours of required administration session hours, particularly as the program gets off the ground. Additionally, changing the practicum rules substantially at this late stage is certain to cause additional headaches for training programs, many of which have been left in limbo for the past several months.

    Distribution and Timing of Practicum Hours

    While a previous proposed version of the rules prescribed a rigid distribution of practicum hours, the final version is slightly more flexible. Welcome language changes now make clear that practicum may take place in Oregon. Under the final proposed changes, the 30 hours of required in-person experience in administration sessions may be as a participant, observer, or co-facilitator, with a maximum of 10 hours from experiencing natural medicine.

    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. group facilitation.

    Practicum CO

    Additionally, up to 20 practicum hours may be completed concurrently with didactic training, provided the student has completed at least 50% of the training program’s didactic education hours. To complete the remaining 20 hours, a student must acquire a training license, which requires completion of all didactic training. Previously, practicum hours could only be earned following completion of all didactic training and issuance of a Training License. During the November 19th final hearing, multiple stakeholders urged regulators to provide additional flexibility regarding distribution of hours, particularly at the outset of the program as facilitator training programs get off the ground.

    Additional Changes

    Under currently-adopted rules, a Clinical Facilitator must contact a participant’s treating provider when a safety screen identifies a risk factor outside of the Clinical Facilitor’s scope of practice, “unless good cause exists.” DORA initially proposed removing this exception, which would have created an unnecessary barrier to accessing regulated Natural Medicine Services for veterans with PTSD, who may risk losing essential Veterans Affairs benefits by seeking a promising treatment that happens to be illegal under federal law. Thankfully, DORA reversed course, and the good cause exemption remains available to those who may need it.

    In a perplexing lack of change to current rules, DORA has rejected significant stakeholder support for allowing registered pharmacists to provide consultation when safety screening identifies a medication interaction as a risk factor. Allowing pharmacists to provide their expertise on drug interactions would only benefit the program by increasing safety and reducing potential bottlenecks, making DORA’s refusal all the more concerning.

    Microdosing

    During the October meeting of the NMAB, the Board finally addressed the subject of microdosing, following months of repeated public requests. After considering and discussing  materials provided by the Healing Advocacy fund regarding microdosing, the Board adopted the following recommendation: 

    For doses less than 2 milligrams of total psilocin, an administration session must last no less than 1 hour in duration and until the participant is showing no obvious effects from natural medicine.

    Continuing the microdosing conversation in November’s meeting, state officials queried the Board’s position on how to handle preparation sessions for microdosing. Under the state’s current reading of the Natural Medicine Code, every administration session must be accompanied by a preparation session, regardless of dosage. The Board ultimately recommended regulators formulate rules that:

    1. Require a full preparation session prior to the first microdose administration;
    2. Allow a shorter preparation session for each subsequent microdose administration;
    3. Exempt subsequent microdosing sessions from the existing rule requirement that a preparation session occur no less than 24 hours prior to administration.

    Regulators also sought input from the Board on the appropriate Facilitator:Participant ratio in group microdosing sessions. As board member Dr. Sue Sisley pointed out, this relatively straightforward question has already been answered by Oregon, where a 1:25 ratio has been allowed for several years without any reported issue. Nonetheless, the Board vigorously debated the question, with some members expressing concern about moving too quickly on the subject, despite having kicked the microdosing question down the road for months. Ultimately, the Board tabled any recommendation until December at the earliest, requesting to hear from a guest speaker regarding microdosing.

    At December’s Board meeting, DORA invited Dr. Andrew Novick, an Assistant Professor of Psychiatry University of Colorado Anschutz involved in psilocybin research, to present on the topic. Dr. Novick spent nearly an hour discussing dense and complex clinical research data, and ultimately concluded that, for the majority of people, a 4mg dose is below the threshold of physically or psychologically perceptible effects. The proposed rules only provide leniency for 2mg.

    Current and Proposed Microdosing Rules

    Under rules adopted on December 12th, doses of 2 mg or less are exempted from a rule which requires a preparation session occur at least 24 hours prior to an administration session. This is an excellent move towards increasing the feasibility of regulated microdosing, removing a potential hurdle for participants to receive regulated microdoses.

    The following additional rules have been proposed, and are scheduled for discussion during the January 6th stakeholder meeting:

    • For doses of 2mg total psilocin or less, the minimum administration session is one hour, which may be extended by the participant or facilitator.
    • Group administration sessions where all participants consume 2mg or less of total psilocin may be conducted with a facilitator:participant ratio of 1:8,6 with a maximum of 64 participants in a group.

    The inclusion of microdosing in the regulated market is an essential and welcome addition, and Natural Medicine, and specifically microdoses, are already easily available under the gifting allowances of personal use provisions. As reported earlier this year by RAND, millions of Americans are already microdosing to perceived benefit. By removing obstacles to microdosing in the regulated natural medicine market, DORA has taken a positive step to support the future health of Coloradans, as well as the program itself. 

    The path to implementing Colorado’s Natural Medicine Program has been a long and winding path, and the Board, regulators, and public stakeholders alike should celebrate this moment. At the same time, it is imperative that the Natural Medicine community as a whole ensure the program is sustainable, equitable, and accessible. While regulators have, on the whole, done an exceptional job of aligning with public and stakeholder feedback, last-minute rule changes and regulatory reversals have sown confusion and frustration. Key issues, such as the scope of at-home facilitation and the framework for microdosing remain unresolved, jeopardizing the program’s accessibility and fairness.

    As the January 14th final hearing approaches, it is critical for regulators to engage transparently with stakeholders and prioritize equity, safety, and autonomy within the framework of Colorado’s Natural Medicine Program.

    An initial stakeholder meeting on rules related to at-home facilitation and microdosing is scheduled for January 6th at 1:30 p.m. MST. The final hearing will be held on January 14th at 12 p.m. MST.

    If you believe access to Natural Medicine should not be limited to Healing Centers, please attend a hearing or submit written comments to dora_dpo_rulemaking@state.co.us

    Appendix A: Timeline of At-home Facilitation Rule Development

    • November 2022: Colorado voters approve the Natural Medicine Health Act, which expressly directs the state to allow administration at private residences.
    • May 23, 2023: Governor Polis signs SB23-290 into law, also permitting at-home facilitation.
    • December 14, 2023: Natural Medicine Advisory Board Public Health and Health Equity subcommittee adopts recommendation:
      • “The State should develop regulations permitting the delivery of Natural Medicine Services in the private residences of patients and facilitators”
    • January 11, 2024: Natural Medicine Advisory Board Public Health and Health Equity subcommittee adopts recommendation encouraging independent facilitator operation.7
    • February 2024: NMAB adopts consolidated recommendations, including the December 14 and January 11 recommendations.
    • April 2024: DORA releases proposed rules permitting administration in a participant’s residence, subject only to reasonable safety guardrails.
    • July 2024: Rules are officially adopted and approved by the Attorney General with no changes to residential administration.
    • September 12, 2024: DORA publishes 25 pages of proposed “cleanup” changes to existing rules. Notably, no changes to at-home facilitation rules were included.
    • September 25, 2024: Initial stakeholder meeting, final hearing scheduled for November 19
    • November 15: DORA inserts changes to at-home facilitation rules
    • November 19: Final Hearing, significant public pushback on last-minute changes
    • Early December 2024: DORA removes changes to at-home facilitation
    • December 16: DORA announces new rulemaking focused on at-home facilitation and microdosing, including severe limitations on residential administration.
    • December 20: Natural Medicine Advisory Board discusses at-home facilitation, however no decision is reached and the subject is tabled due to time constraints.

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    1. Cultivation, Manufacturing, Testing, and Healing Centers.
    2. A detailed account of this controversy is provided in Appendix B.
    3. A timeline detailing the development of at-home facilitation is provided in Appendix A.
    4. Last-minute additions are underlined.
    5. Dr. Kumar did mention that additional support staff would have been helpful during.
    6. Current rules permit a ratio of 1:4 for group administration sessions.
    7. Facilitator Independence from Healing Center- Safe and best practice methods for facilitators and participants to engage in natural medicine services independent of a healing center.” Adopted Consolidated Recommendations, page 54.