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Colorado’s Draft Natural Medicine Rules: Full Breakdown & Commentary

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

Nearly fifteen months after Colorado voters approved the Natural Medicine Health Act, the public got its first glimpse of draft rules that will govern the regulated psychedelics program created by the Act. In February’s meeting of the Natural Medicine Advisory Board, the Department of Regulatory Agencies (“DORA”) presented draft rules for facilitator licensing and training programs. These rules, while still under development, represent months of hard work by the Advisory Board and state regulators. They also represent a significant improvement over the only other state-regulated psychedelics program in the country. Unlike Oregon’s Psilocybin Services program, which explicitly precludes psilocybin services from being combined with mental healthcare, these rules honor the will of the voters to integrate psychedelic healing into traditional healthcare systems. By providing medical and mental health professionals a framework to incorporate psychedelic care in their existing practices, the draft rules open the door to profound opportunities for deep spiritual and psychological healing in Colorado.

With official rulemaking now expected to begin in May 2024, these draft rules are still far from final. That is good news, as there is certainly room for improvement. Rules requiring medical clearance for any participant taking psychotropic medicine appear overly broad and could create substantial barriers to access to care. The draft rules also leave open questions around the exact mechanics and requirements of training licenses, consultation periods, ethical rules, and scopes of practice. Regulators still have plenty of time to refine the rules before rulemaking begins and hopefully many of these questions and issues will be addressed before then.

On Friday, March 8, 2024, at 2:00 P.M, DORA will hold a virtual Stakeholder Meeting on the draft rules. Members of the public are invited to provide oral comments on the draft rules during the meeting. The public may also submit written comments to dora_dpo_rulemaking@state.co.us by March 6th.

Below we’ve summarized the draft rules and added commentary where appropriate. To read what the Natural Medicine Advisory Board had to say about these rules check out Natural Medicine Advisory Bulletin 9 (forthcoming). If you’re looking for a high-level overview of the rules, as opposed to a deep dive, see our shorter piece.

Note: Commentary by Vicente LLP, indicated by italics and a blue box, does not necessarily reflect the views of Psychedelic Alpha.

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    License Types and Requirements

    The Department of Regulatory Agencies has proposed two facilitator license types simply called “Facilitator” and “Clinical Facilitator.” Rather than separate license types, individuals holding a secondary professional license in Colorado that allows them to diagnose and treat medical or behavioral/mental health conditions may receive a Clinical Facilitator license. Both Facilitator and Clinical Facilitator licenses are available through an “Original Licensure” and “Accelerated Licensure” pathway. The “Original Licensure” pathway is, in essence, the baseline requirements of the license. The “Accelerated Licensure” pathway describes where an applicant may substitute previous experience for the baseline requirements.

    Additionally, the Facilitator license will be available by endorsement via an Occupational Credential Portability Program (“OCPP”). This option will allow facilitators who have held a valid facilitation license in another state for one year to apply directly for licensure in Colorado. There is no OCPP option for the Clinical Facilitator license at this time, presumably because no other state offers such a license. However, nothing prohibits someone who holds a secondary professional license and a facilitator license in another state from applying for licensure in Colorado through the OCPP program for both Facilitation and their secondary license.

    All license applicants must be over the age of 21, possess Basic Life Support certification, complete an application, and pay an application fee.

    Facilitator

    The proposed “Facilitator” license will be available to anyone who completes an Approved Facilitator Training Program which covers 150 hours of training, 40 hours of supervised practice, BLS certification, and 50 hours of consultation. This includes individuals who hold non-diagnosing professional licenses such as massage, acupuncture, unlicensed psychotherapy, and traditional and complementary medicine. It also includes Indigenous and religious practitioners who wish to facilitate in the regulated space.

    Those holding a Facilitator license may not engage in the practice of medicine or practice psychotherapy, as defined in Colorado statute. They are prohibited from independently providing natural medicine services to participants with active diagnoses of certain risk factors1, or who are taking lithium or other antipsychotic medications. However, a facilitator may provide natural medicine services to participants meeting these criteria if the participant was directly referred for natural medicine services or if the participant’s medical or mental health professional provides “clearance”. 

    Additionally, if a participant is taking any psychotropic medication other than lithium or an antipsychotic, the facilitator must require the participant to be cleared by an advanced practice medical professional.2

    Issues: The requirement that a participant receive clearance from their medical or mental health professional presumes that the participant has 1) a relationship with a professional and 2) that professional has an accurate understanding of psychedelics. This is problematic given that many people do not have standing relationships with a healthcare professional, and because many professionals trained in the western medical paradigm lack an accurate understanding of natural medicine and psychedelics. This rule will likely create a cottage industry of medical and mental professionals providing “clearance.” Participants may be seeking natural medicine services specifically because they have not found adequate treatment in the western model. The alternative, being directly referred for natural medicine services, adds both logistical and financial hurdles to accessing care. Should certain participants be forced to see certain facilitators?

    Occupational Credential Portability Program (Out-of-State Facilitators)

    Individuals who have held a facilitation license in another state for one year will be eligible for licensure by endorsement, provided the scope of practice in that state is substantially similar to that of Colorado.

    Accelerated Training (Legacy Facilitators)

    The accelerated training pathway for the Facilitation license is intended for legacy healers who are not licensed as facilitators in any state. Applicants must demonstrate experience providing facilitation services for at least 40 participants with at least 200 hours of experience conducting administration sessions over a period of at least two years. Applicants must also complete a BLS certification and 25 hours of educational coursework on Ethics and Colorado Natural Medicine Rules and Regulations. 

    This rule essentially asks legacy facilitators to provide evidence of their prior work, which was at the time illegal under state law and still is illegal under federal law. It will be interesting to see how this plays out, and hopefully the state can provide adequate assurances to avoid legacy facilitators remaining underground.

    Clinical Facilitator

    Clinical Facilitators must hold a valid behavioral, mental health, or medical license3 in Colorado and may not provide facilitation services outside the scope of their secondary license or non-clinical Facilitation license. For example, a Clinical Facilitator who is also a Licensed Addiction Counselor (LAC) may only provide facilitation services within the scope of practice of a LAC or a non-clinical Facilitator license.

    If a participant has an active diagnosis of a risk factor that is outside the Clinical Facilitator’s secondary scope of practice, the Clinical Facilitator may only provide facilitation services if the participant has been directly referred for natural medicine services, or has been cleared by their treating professional.

    Similarly, if the participant is taking lithium or antipsychotic medications, and the Clinical Facilitator does not prescribe lithium or antipsychotic medications within their scope of practice, the participant’s treating provider must clear the participant for natural medicine services.

    These rules seem to imply that a Clinical Facilitator cannot provide facilitation services to anyone that exhibits a possible risk factor outside their scope of practice, whether or not that person is seeking treatment for that risk factor. Further, it is unclear if the definition of “risk factor” is limited to the list given in the rules4, or if it can be interpreted to mean any condition under the sun that falls outside the Clinical Facilitator’s scope of practice. The latter interpretation would not make sense because it would imply greater restrictions for Clinical Facilitators than for non-clinical Facilitators, but the current language is not clear on which is intended.

    Accelerated Licensure for Clinical Facilitators

    Upon petition, Clinical Facilitator applicants may be exempted from portions of an Approved Facilitator Training Program if they have completed substantially equivalent training or coursework as part of the education related to their secondary license. Applicants must still complete a 40-hour practicum, BLS certification, 50 hours of consultation and 25 hours of  educational coursework on Ethics and Colorado Natural Medicine.

    Interaction With Secondary Licenses

    Clinical Facilitators must maintain their secondary license in good standing. If the secondary license expires or becomes inactive, the Clinical Facilitator may not practice as a Clinical Facilitator. Additionally, any disciplinary actions related to the secondary license must be reported to the Director within 30 days.

    The rules also recommend that “To the extent that a Clinical Facilitator licensee provides facilitation services to participants that also include services within the scope of practice of their secondary license . . . any evaluation of the licensee’s performance of services be assessed first within the context of generally accepted standards of practice for facilitation of natural medicine services.”

    Distinguished Educator

    The Distinguished Educator License will be available to individuals with significant pre-existing facilitation experience. Distinguished Educators must be invited to serve on the faculty of a natural medicine education program and may provide natural medicine services only for the purposes of education and training, within the context of their role in the training program. Distinguished Educators may only provide natural medicine services in healing centers or other physical locations affiliated with the education program. They may not accept payment for natural medicine services other than their salary as a faculty member of a training program. A Distinguished Educator license is valid for one year. Distinguished Educators may not independently own a healing center. If a Distinguished Educator wishes to own a healing center, they must contract or employ a licensed Facilitator or Clinical Facilitator. Distinguished Educators may be employed by multiple training programs, provided they notify the regulatory authority.

    In evaluating an application for a Distinguished Educator License, the Director may consider:

    1. If the applicant holds a current facilitator license in good standing in their home jurisdiction or in any other country.
    2. The applicant’s facilitator education and training meets or exceeds the minimum educational requirements for Facilitator licensure in Colorado.
    3. The applicant holds a national or professional certification conferred by a national professional organization in the field of psychedelic medicine OR holds certification outside of the United States.
    4. The applicant has undergone extensive clinical post-graduate training in facilitation.
    5. The applicant has demonstrated recent clinical experience by being actively and continuously involved in the practice of facilitation for at least a two year period immediately preceding the filing of the application and has demonstrated expertise that meets or exceeds the clinical skills required by the faculty position.
    6. The applicant has demonstrated teaching ability to include prior experience in an academic position, including other visiting professorships or professorships.
    7. The applicant has published peer-reviewed articles or noteworthy research in respected medical or scientific publications.
    8. The applicant’s training, skills, or talents will contribute uniquely to facilitator education in Colorado.
    9. The applicant demonstrates that they will continue to contribute uniquely to facilitator education in Colorado during the ensuing period of licensure.
    10. The applicant’s other facilitator licenses and privileges are unrestricted and have not been subject to discipline by any licensing body or health care entity and the applicant is not under investigation by any licensing body or health care entity.
    11. The applicant is free from prior malpractice judgments, settlements, or their equivalent.
    12. The applicant should not have been convicted of any felony offenses against persons or property, or those involving fraud, dishonesty, moral turpitude, domestic violence, child/elder abuse, or drug diversion. In considering applications from individuals with any of the identified felony convictions, the Director will apply rehabilitation principles identified in sections 12-20-205 and 24-5-101, C.R.S.

    Hopefully, the requirements around being free from malpractice and certain felonies are not an absolute bar and the Director uses their reasonable discretion to make sure experienced Distinguished Facilitators feel comfortable coming to Colorado. Many professionals settle unfounded malpractice claims because it is cheaper than going to trial.

    Training License

    Following completion of didactic education and BLS certification, Facilitator and Clinical Facilitator applicants may apply for a Training License. While operating under this license, a trainee may engage in natural medicine services under the supervision of a facilitator licensed in the state of Colorado. The Trainee must participate in, and document, regular meetings with the supervising facilitator, which may occur virtually or in-person. The trainee must apply for a full Facilitator or Clinical Facilitator license within 2 years.

    Under the draft rules, Training Licensees must engage in consultation with “an individual experienced in the provision of natural medicine services” for a minimum of 50 hours over 6 months. Consultation may be conducted virtually and in groups of up to 10 trainees. The consultation period must include case review and at least 10 hours of ethical training focused on issues that arise during the trainee’s facilitation work. Both the supervisor and applicant must maintain documentation of consultation hours, verified by the supervising consultant. Supervisors must evaluate the applicant in use of non-directive approach, relational boundaries and use of touch, cultural competence, non-ordinary states of consciousness, self-care, and ethics.

    Issues: As written, draft rules around the training license and consultation period leave many open questions, which may lead to confusion about what is required versus what is permitted. First, it is unclear if a Training License is required. Under the current draft rules, applicants may apply for a Training License, but are not explicitly required to. An additional source of confusion stems from a lack of clarity around the consultation period. The consultation period was recommended based on an evident need in Oregon for longer-term support of new facilitators as they gain real-world experience and crystallize the knowledge gained through a training program. It is listed as required in several places, but the details are only found under Training License rules.The Training License was recommended so that a prospective facilitator who has completed everything except the consultation can charge for services while in the consultation period, under supervision. If the consultation period is mandatory, it would imply a mandatory Training License as well. Otherwise, a facilitator-to-be risks committing unlicensed facilitation to complete the consultation period. 

    License Mechanics

    Renewal, Reinstatement, Inactivation, Reactivation, Reporting

    Facilitator and Clinical Facilitator licenses must be renewed every two years along with documentation of completed continuing education requirements. Distinguished Educator licenses must be renewed annually and accompanied by updated documentation. Training licenses may not be renewed beyond the initial two-year lifespan.

    Expired licenses may be reinstated upon payment of fees and completion of a reinstatement application. Facilitators and Clinical Facilitators in good standing may request their license be made inactive. Any license that remains inactive or expired for more than two years may be required to demonstrate “competency to practice” before reinstatement.

    Licensed facilitators must maintain records for three years for each participant to whom they provide natural medicine services. Licensed facilitators must also report any of the following to the Office of Natural Medicine within 30 days of occurrence:

    • Felony convictions under C.R.S. § 12-170-109(1)(b).
    • Pleas of guilty or nolo contendere to felonies under C.R.S. § 12-170-109(1)(b).
    • Adverse actions taken against the licensee by any other licensing body, peer review body, healing center, health-care institution, professional society or association, a governmental agency, a law enforcement agency, or other disciplinary actions.
    • The surrender of a license or other authorization to practice facilitation or the provision of natural medicine services in another state or jurisdiction.
    • The surrender of membership of any healing center or other authorized health care institution’s staff or in any professional association or society while under investigation by any of those authorities or bodies for acts or conduct similar to acts or conduct that would constitute grounds for action as described in article 170.

    Continuing Education

    In addition to maintaining current BLS certification, facilitators must complete 40 hours of continuing professional education, including at least 5 hours of ethics education, related to natural medicine services during each two-year licensure period. Continuing education requirements may be satisfied through attendance at workshops, seminars, symposia, colloquia, invited speaker sessions, institutes, or scientific or professional programs offered at meetings of local, state, regional, national, or international professional or scientific organizations. Up to five hours of the required 40 hours of continuing education may be accrued from attendance at nonaccredited programming.

    There is currently no accreditation process for continuing professional education programs related to natural medicine. Additionally, facilitator peer-support groups would be an excellent addition to continuing education options, allowing facilitators to learn from each other and creating space for the ancient practice of wisdom-sharing in the regulated natural medicine market.

    Experience and Education Requirements

    Except as authorized through accelerated or OCPP pathways, all Facilitators and Clinical Facilitators must complete at least 150 hours of didactic instruction, at least 40 hours of supervised practicum experience, and at least 50 hours of consultation.

    Educational Requirements

    Facilitators and Clinical Facilitators must complete at least 150 hours of didactic education which must contain the following topics and hours:

    • Facilitator Best Practices (5 hours)
    • Ethics and Colorado Natural Medicine Rules and Regulations (25 hours)
    • Relational Boundaries and Introduction to Physical Touch (10 hours)
    • Physical and Mental Health and State (25 hours)
    • Drug Effects, Contraindications, and Interactions (5 hours)
    • Introduction to Trauma Informed Care (10 hours)
    • Introduction to Suicide Risk (5 hours)
    • Indigenous, Social, and Cultural Considerations (10 hours)
    • Screening (5 hours)
    • Preparation (10 hours)
    • Administration (10 hours)
    • Integration (10 hours)
    • Group Facilitation (10 hours)
    • Facilitator Development and Self-Care (10 hours)

    Didactic education may be completed virtually, however at least 50% of virtual education must be conducted using synchronous virtual learning.

    The training rules do not include much training on adverse events, derealization or spiritual emergencies. Hopefully, we will see the private sector step in with more focus on safety.

    Supervised Practice (Practicum)

    Facilitator training programs must require students to complete supervised practice (practicum) training which provides an opportunity to experience, facilitate and observe the facilitation of non-ordinary states of consciousness. A practicum may include placement at a practicum site where students can observe and assist in natural medicine services under the supervision of a practicum site supervisor. Licensed Healing Centers may serve as supervised practice sites. A practicum site must obtain written client consent prior to allowing a client to be observed by practicum students and prior to sharing any client information with practicum students or a training program.

    Where supervised in-person training during natural medicine services is not available or accessible, supervised practice training may additionally include, but is not limited to, observation of taped facilitation sessions that were recorded with participants’ consent, apprenticeship in a psychedelic peer support organization, role-playing, and experience with altered states of consciousness that are not drug-induced, for example, breathwork, meditation or spiritual journeys.

    Students must complete a minimum of 40 hours of supervised practice training, including at least 30 hours (about 5 to 6 administration sessions) of direct experience in administration sessions. The remaining 10 hours may consist of consultation relating to the student’s direct administration experience.

    Until March 31, 2025, a supervisor must be affiliated with an Approved Training Program and may be licensed as a Facilitator, Clinical Facilitator, or Distinguished Educator. All supervised practice hours are required to be conducted in-person. After March 31, 2025, supervisors are not required to be affiliated with an Approved Training Program.

    Approval of Facilitator Training Programs

    Facilitator Training Programs seeking “approved” status must submit an application to DORA’s Office of Natural Medicine and receive approval prior to offering classes to students. Upon approval, training programs may advertise that the program has been approved by the Office of Natural Medicine and advertise using the words “DORA Approved Facilitator Natural Medicine Training Program.” Programs may also advertise that students who successfully complete the program will have met all of the training program/educational and experiential requirements for a Facilitator license, other than basic life support. Approved facilitator training programs must clearly document and communicate fees for training, including whether the Approved Facilitator Training Program will pay the cost of a Training license for its students and/or the cost of a Facilitator or Clinical Facilitator licensure application fee at the completion of the student’s training program.

    Pre-Approval

    The Office of Natural Medicine anticipates the full approval process will be established by March 31, 2025. Prior to the establishment of the approval process, Training programs may submit a request for pre-approval to the Office of Natural Medicine by submitting the same fees and information required for approval. Pre-approval will allow programs to operate and offer courses.

    It’s great to see DORA being proactive here, as the pre-approval process is key to ensuring Facilitators can be licensed by the time the first Healing Centers open in the spring of 2025.

    Initial Approval

    Approved training programs must meet requirements regarding organization, administration, and faculty composition. Programs seeking approved status must submit an application which includes:

    • Course outlines for every training hour along with an explanation of how that course meets one of the course requirements described.
    • Proposed program requirements for students to complete their practicum requirements.
    • If the education program intends to offer consultation for newly-licensed facilitators, the application must also address the training program’s plan to satisfy consultation requirements.
    • Time period within which students must complete the proposed training program.

    Program Administration & Organization

    Approved training programs must maintain documentation related to student records, program operations, and compliance with faculty qualification rules. Approved programs are required to submit an annual report to the Office of Natural Medicine. Programs must comply with these rules before admissions can be increased more than 25% over the previous admission number approved by the Office of Natural Medicine. Programs are required to undertake internal evaluations.

    Approved Facilitator Training Programs must be able to demonstrate the following organizational aspects:

    • A governing body.
    • Sufficient financial resources for the program’s operation and goals.
    • An organizational chart.
    • Statements of mission, purpose, and outcome competencies, to be approved by the Office of Natural Medicine.
    • Standards for recruitment, advertising, and refunding tuition and fees.
    • Student support services, including, but not limited to health care, counseling and intervention for disabilities, academic achievement strategies, career placement and financial aid.
    • Student policies that are accurate, accessible to the public, non-discriminatory, and consistently applied.
    • Records of written complaints about the training program, as well as how the program responded.
    • A Teaching and learning environment conducive to student academic achievement.

    Faculty Composition

    An approved program must have at least two full-time faculty members, including a Program Director. Beginning on January 1st, 2026, an approved program must have a licensed Facilitator or Clinical Facilitator on staff full-time. 

    The Director of an approved training program must hold a Facilitator license, or a secondary professional license that would qualify them for a Clinical Facilitator license.

    The Director’s responsibilities must include:

    1. Insuring and documenting the Approved Facilitator Training Program compliance with the Natural Medicine Health Act, the Office of Natural Medicine’s rules and regulations, and all other state or federal laws and regulations.
    2. Providing a current written job description to the Office of Natural Medicine for all faculty positions.
    3. Developing and maintaining the relationship between the Approved Facilitator Training Program and the governing body, including but not limited to acting as liaison with other programs within the governing body and with other Approved Facilitator Training Programs.
    4. Demonstrating leadership within the faculty for the development, implementation and evaluation of the curriculum and other Approved Facilitator Training Program components.
    5. Participating in the budget planning process for and administration of the Approved Facilitator Training Program budget.
    6. Recruiting and selecting faculty for employment, designing and monitoring development plans for faculty, conducting performance reviews of faculty, and participating in faculty promotion and retention.
    7. Developing and coordinating the use of educational facilities and practicum resources.
    8. Identifying and advocating for services needed by students in the Approved Facilitator Training Program.
    9. Acting as liaison with the Office of Natural Medicine.
    10. Developing and maintaining ongoing relationships within the community, including fostering the Approved Facilitator Training Program’s responsiveness to community/employer needs.
    11. Participating in activities that facilitate the director of the Approved Facilitator Training Program’s professional expertise in the areas of administration, teaching and maintenance of facilitation competence.
    12. Determining the need for additional faculty release time for administrative duties. The director of each Approved Facilitator Training Program remains responsible for the above duties, even if they delegate those duties to another person.

    While regulatory structure is to be anticipated, the rules regarding training program approval are quite burdensome and favor larger, well-funded entities. Sole proprietors of facilitator training programs are effectively barred from receiving approval by the requirement of two full-time staff members. These rules appear to draw on similar DORA rules for approval of nurse training programs and are not reflective of the realities of the existing facilitator training market. Additionally, the rules foreclose most apprenticeship-based training programs (which are more common in Indigenous cultures) due to the requirements for multiple full-time staff. Hopefully, DORA will use its “alternative educational program” discretion to approve these types of programs.

    Continued Approval, Revocation of Full Approval, Conditional Approval, Restoration of Full Approval, and Denial of Approval

    Draft rules provide mechanisms by which the Office of Natural Medicine may verify that an approved program continues to meet the requirements of approval, including surveys and site visits. Approved programs must report major program revisions to the Office of Natural Medicine including major changes in program goals, changes in the number of educational or clinical practice hours, or a 25% change in student numbers admitted, types of students, admission times, and progression options. If the Office of Natural Medicine determines an approved program no longer meets the requirements of approval, the Office of Natural Medicine may place the program on “conditional approval” or withdraw approval. In doing so, the Office of Natural Medicine must notify the program in writing of specific deficiencies. The program must respond to the notice within 30 days and cure deficiencies within 90 days. After consideration of available information, the Office of Natural Medicine may reinstate the program’s approved status, withdraw approval completely, or place the program on conditional approval. Adverse changes to a program’s approval status are appealable under the Colorado Administrative Procedure Act within 60 days.

    Unaddressed Topics

    In addition to the questions posed by the draft rule framework, most topics remain to be addressed. Notably absent are ethical rules for facilitators, however the draft rules reserve space for standards of practice and disciplinary procedures. Draft rules also allude to facilitation occurring outside of healing centers, but do not address the subject directly. This remains one of the bigger questions in the program. If the NMAB recommends that facilitators themselves be licensed to provide natural medicine services in residences or non-healing-center locations, those rules would fall to DORA to develop and enforce. Likewise, is DORA going to permit telehealth for preparation and integration sessions?

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    1. Risk factors identified by rule are: cardiovascular disease; uncontrolled hypertension; diseases of the liver; seizure disorders; severe chronic medical illness; terminal illness; severe suicidal behavior (i.e., severe current suicidal ideation, current suicidal intent, a current plan for suicide); severe (PCL-5 score above 33) and current PTSD; psychosis; schizophrenia; schizoaffective disorders; and bipolar disorder.
    2. Physician (MD or DO),  Advanced Nurse Practitioner (APN), or Physician Assistant (PA).
    3. (PSY) Psychologist, (LSW) Licensed Social Worker, (LCSW) Licensed Clinical Social Worker, (MFT) Marriage and Family Therapist, (LPC) Licensed Professional Counselor, or (LAC) Licensed Addiction Counselor; or Medical Doctor (MD), Doctor of Osteopathic Medicine (DO), advanced practice nurse (APN), including Nurse Practitioner (NP), or Physician Assistant (PA).
    4. The current language of this rule reads "A Clinical Facilitator who does not manage or treat a participant's physical or mental condition (including conditions such as cardiovascular disease, uncontrolled hypertension, diseases of the liver, seizure disorders, severe chronic medical illness, or terminal illness) must obtain clearance from the participant's treating provider prior to providing natural medicine services."