Insights

Colorado Natural Medicine Program Draft Rules Released And Public Hearing Scheduled

By Barine Majewska

Apr 24, 2024

On April 18, 2024, the Department of Regulatory Agencies (DORA) presented additional draft rules for Colorado’s regulated natural medicine market to the Natural Medicine Advisory Board, focused on facilitator conduct and relationships, administrative sessions, informed consent, record keeping and advertising. These rules follow the prior draft of the rules released by DORA on February 16, 2024, which focused primarily on facilitator qualifications, education requirements, and training programs. Like the prior rules, these draft rules will be subject to additional review, stakeholder engagement, and public comment prior to becoming final. Additionally, many of the issues in the draft rules were recently discussed by the Natural Medicine Advisory Board and its subcommittee—so expect some changes around physical touch and dosing.

DORA is holding a virtual public hearing on these new rules on April 26, 2024 at 2 p.m. MT. If you have any thoughts or concerns, now is the time to voice them! Participants can make oral comments during the webcast or submit written comments. Register here to attend the meeting.

The Natural Medicine Division of the Department of Revenue (DOR) is scheduled to hold a stakeholder meeting on Healing Center requirements on May 1, 2024 at 9 a.m. MT. If you would like to participate, you can attend in person or virtually. Learn how to participate, including instructions for submitting a written comment.

Physical Touch

The draft rules go into detail about the use of physical touch during administrative sessions. They define “supportive touch” and clarify that it must be consented to by a participant prior to the administration session, and that it may not be used on any body part other than hands, feet, or shoulders, or otherwise be sexual in nature. Physical touch must always be limited to the parameters described and consented to in a physical touch contract with the participant. The facilitator and participant must discuss simple and specific words and gestures the participant is willing to use to communicate about touch during administration sessions, including, for instance, the word “stop” or a hand gesture that would direct the facilitator to stop touch. The participant may always revoke consent during the administrative session. Physical touch that is used solely for facilitator or participant pleasure is never permitted.

A facilitator may only use forms of physical touch for which they have received appropriate education and training, and must not permit any physical contact between a participant and any other individual present during an administration session unless the participant has given specific consent to physical touch by that individual in the physical touch contract. In group administration sessions, the facilitator must not allow physical touch between participants unless participants have consented to participant touch.             

Sessions

The draft rules prescribe certain procedures for facilitators to follow, including an initial consult or informal inquiry with the potential participant (which is different from the preparatory session), provision of a written screening tool to potential participants, and a list of written disclosures the facilitator must make to the participant.

The rules also list the things that a participant must attest to in writing, including the accuracy of all health information and risk factors provided by the participant, informed consent to risks, expectations and circumstances of the services being provided, and parameters and extent of consent to physical touch.

During an administration session, a facilitator must make all reasonable efforts to prevent physical and psychological harm to a participant, including but not limited to monitoring a participant’s vital signs and hydration, reasonable steps to prevent physical injury, continually assessing the participant for suicidality and self-harm, and restricting the movements of a participant if required for the safety of the participant or others.

Facilitators may not be under the influence of natural medicine or any other intoxicant while providing services. The draft rules also specify that when a facilitator knows or should know that their own state of mind or physical condition will prevent them from competently performing their work-related activities, the facilitator must take appropriate steps.

If a facilitator determines that a participant or the facilitator would benefit from having an additional individual present during an administration session or would benefit from a video recording of an administration session, the facilitator must inform the participant of their recommendation. If the participant rejects the facilitator’s recommendation, the facilitator may refuse to continue the provision of Natural Medicine Services and refer the participant elsewhere. While administration sessions are permitted to be in certain authorized locations outside of healing centers, an administration session may not occur outside a healing center if a participant refuses to authorize either another individual to be present during the administration session or a video recording of the administration session. If an administration session occurs outside a healing center, the facilitator must maintain custody of all unused natural medicine products and must return them to the healing center following the administration session.

The draft rules state that the maximum dosage a facilitator may administer is equivalent to a maximum of 30 milligrams, and the duration of an administration session must be at least three hours for doses of 10 milligrams or less, and at least 5 hours for doses of 11 to 30 milligrams.

Group administration sessions are permitted by the rules at the discretion of the facilitator so long as no more than four participants per facilitator, and no more than 64 participants total, are present during the group administration session.

A facilitator or healing center may not charge a separate fee for an integration session. Group integration sessions are permissible if each participant has given consent to a group integration session.

Informed Consent

The draft rules also lay out the informed consent that a facilitator must obtain from each participant and  document, including, among other things:

  • The scope of services that will be provided

  • An accurate description of natural medicines used

  • Potential risks, benefits, and alternatives to the use of natural medicine

  • All fees and costs

  • Decisions related to safety plan, physical touch, the presence of other individuals

  • The use of any audio or video recording before each administration session

A participant may withdraw their consent at any time and that withdrawal must also be documented by the facilitator. Importantly, if a facilitator holds a secondary license that requires the licensee to be a mandatory reporter, or if a facilitator is otherwise a mandatory reporter, the facilitator must disclose to a prospective participant that the facilitator is a mandatory reporter, together with a description of the facilitator’s scope of required reporting.

The draft rules further detail what constitutes fully informed consent including, among other factors:

  • The risks of consuming natural medicines

  • A description of how natural medicines alter the human state of consciousness and how that may disrupt a participant’s ability to make decisions, give or revoke consent, or stop unwanted interactions

  • A participant’s right to request another non-participant individual, who is either a licensed facilitator or an authorized representative of a healing center, be present during an administration session

  • A participant’s right to request to have a video recording taken of an administration session

Facilitator Relationships

A number of limitations on the relationships facilitators may have with participants are also presented. Facilitators may not provide natural medicine services to, or have romantic or sexual relationships with, people over whom they have authority. This includes, but is not limited to, students, supervisees, research participants, and employees. Facilitators may not have romantic or sexual relationships with any participant, or any participant’s partners or immediate family members, for a period of one year following the termination of Natural Medicine Services to the participant. Additionally, facilitators may not provide natural medicine services to any participant with whom the facilitator already has a romantic, sexual, or close personal relationship.

Interestingly, the rules also state that a facilitator may not offer or provide Natural Medicine Services as a means of establishing a personal relationship with a participant. It will be interesting to see how this particular rule is interpreted and received. A facilitator may also not engage in any financial transactions with any participant, the participant’s partners, or the participant’s immediate family members that would violate the facilitator’s duty of loyalty to the participant.

There are other more general rules regarding facilitator conduct including practicing within the scope of any secondary licenses and within bounds of competence, maintaining such licenses in good standing, and collaborating with other professionals as necessary.

Record Keeping

Record-keeping rules are also presented. For each participant who receives natural medicine services, the facilitator must retain extensive records including, among other information:

  • A copy of the participant’s completed demographic information form, informed consent document, transportation plan, physical touch contract

  • Natural medicine products, including a unique identification number, consumed by each participant, including the amount of product consumed and whether it was consumed in a single dose or multiple doses

  • Any adverse reactions that required medical attention or emergency services

Such records must be retained confidentially, for a minimum of seven years and be presented upon a request for records. All such records related to a participant or prospective participant constitute medical data and must be stored, used, and disclosed in strict accordance with applicable laws and regulations. The rules expressly state that any disclosure of such records should be treated in accordance with the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). Clinical facilitators must comply with any more stringent requirements of recordkeeping required by their secondary license.

Termination of Services

There are detailed rules regarding the termination of services, including having a written protocol for termination, terminating when the facilitator reasonably believes the participant isn’t receiving benefit from or is being harmed by the services, there is threat to the facilitator, and making appropriate referrals (without a fee) to other healing centers or facilitators.

Advertising

Limited guidelines around advertising are also provided, including ensuring that statements are correct, honest, and consistent with current scientific literature, clarifying that no solicitation of testimonials is permitted (although collected testimonials may be displayed). The rules clarify that the purpose of regulated natural medicine services, the terms “sitter,” “guide” and “facilitator” are synonymous, and that individuals who are not licensed as facilitators are prohibited from referring themselves as “guides” or “sitters.”

Anticipated Changes

The Natural Medicine Advisory Board (Board) on April 19 discussed a number of proposed changes to the rules. Their recommendations are only advisory, but it seemed like DORA was relying heavily on the Board’s feedback. First, the Board suggested removing the words “sitter” and “guide” as prohibited words to use unless an individual was licensed. Second, they discussed dosing and removed the proposed dosing cap in favor of relying on standards of care. Third, they discussed how to define and whether to permit therapeutic hugs. They also agreed on making an exception to the rules on touch for licensed massage therapists to allow for certain extended touch. DORA agreed to bring back revised language on consensual touch to the Board. Finally, the Board suggested removing the listing of specific conditions in the rules that would require the involvement of additional professionals and instead rely on mandating and utilizing a safety screen. We will see which of these recommendations will make it into the next round of rules.

Vicente LLP is closely following the implementation of the Natural Medicine Health Act. If you have questions about rules or are interested in participating in the program, please contact our Psychedelics & Emerging Therapies team at 303-860-4501 or via our contact form.

View our Colorado Natural Medicine Health Act Tracker, in collaboration with Psychedelic Alpha.

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