4 Colo. Code Regs. § 755-1-6

Current through Register Vol. 47, No. 22, November 25, 2024

Section 4 CCR 755-1-6 - STANDARDS OF PRACTICE

6.1 Authority

Section 6 of these rules and regulations are adopted pursuant to the authority in sections 12-20-204, 12-170-105(1)(a), and 12-170-108(3), C.R.S., and are intended to be consistent with the requirements of the State Administrative Procedure Act, sections 24-4-101, et seq., C.R.S. (the "APA"), and the Natural Medicine Health Act of 2022 at sections 12-170-101, et seq. and 44-50-101, et seq., C.R.S.

6.2 Statement of Basis and Purpose

Section 6 of these rules and regulations shall govern the process for the safe provision of regulated natural medicine services.

6.3 Documentation and Disclosure Requirements

A. A facilitator must complete and retain records for every participant to whom they provide Natural Medicine Services. To the extent available, a facilitator must use forms approved by the Director for all documentation requirements. Records may be maintained electronically.

B. A facilitator must maintain the following records:

1. Completed demographic information form;

2. Completed informed consent document;

3. Completed preferred means of communication document;

4. Completed transportation plan and any deviation from the participant's transportation plan;

5. Completed agreement between participant and facilitator or healing center regarding fees and any other financial arrangements;

6. Completed physical touch contract;

7. Completed participant safety and support plans;

8. Completed safety screen tool;

9. The date, start time, and end time for every preparation, administration, and integration session;

10. The regulated natural medicine product(s), 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;

11. Any adverse reactions that required medical attention or emergency services;

12. Any other documentation required by regulatory agencies in Colorado related to or in service of the cultivation, production, distribution, and/or use of natural medicines as regulated by Colorado law;

13. Outcome information, to the extent provided by the participant; and

14. For any facilitation that occurs outside of a healing center, disclosures regarding the differences between a licensed healing center and a private residence and the participant's consent to an additional representative or a video recording.

C. Records required by this rule must identify the participant receiving services and be searchable by participant's name so that a facilitator may produce them pursuant to a request for records.

D. Participant records must be stored and maintained for a minimum of 3 years.

E. Records may only be destroyed in a manner that maintains participant confidentiality, such as a commercial shredding service.

F. A facilitator is responsible for maintaining participant confidentiality, understanding the requirements of maintaining participant confidentiality, including all legal requirements, and should consult with their legal counsel, as needed.

G. A facilitator may not withhold records under their control that are requested for a participant's Natural Medicine Services because the facilitator has not received payment for Natural Medicine Services.

H. A facilitator may delegate the collection of information or completion of certain forms to properly trained staff members. The facilitator must review all forms and information compiled by staff. The facilitator may not delegate completion of the informed consent document; the physical touch contract; or the safety screen tool.

6.4 Confidentiality of Participant Records

A. Purpose. These rules have been adopted by the Director to clarify confidentiality and privacy requirements for facilitators with respect to participant records and information.

B. Unless a participant or prospective participant gives their consent prior to the disclosure, a facilitator must not disclose a participant's or prospective participant's personally identifiable information or confidential communications made between the participant or prospective participant and the facilitator to the public, third parties, or any government agency, except as allowed for purposes expressly authorized pursuant to article 170 of title 12, C.R.S., article 50 of title 44, C.R.S., these Rules, or for state or local law enforcement agencies to access record and information for other state or local law enforcement pursuant to a bona fide law enforcement investigation. Facilitators are responsible for their staff that assist participants and prospective participants and shall ensure staff are aware that they must maintain confidentiality.

C. All information and records related to a participant or prospective participant constitute medical data pursuant to section 24-72-204(3)(a)(I), C.R.S., and any such information or records may only be disclosed to those persons directly involved in an active investigation or proceeding.

D. Records required by this rule must be stored in a secure fashion so that only the facilitator or any authorized persons at healing centers, including those with participant approval, may access them.

E. When facilitators are required to release information about participants, they must follow all pertinent laws and regulations and provide the minimum amount of information necessary to respond. Facilitators should also inform participants about the release of protected information when possible and permissible.

F. To the extent that records may be disclosed, for example, in response to a request for disclosure to a participant's treating health care or behavioral health provider, facilitators, and any other individual authorized to be in possession of participant records should treat all records associated with the provision of Natural Medicine Services to a participant as protected by the federal law, Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. 104-191 (1996).

G. Upon request, facilitators and other individuals authorized to possess participant records must provide a copy of all records to the participant. Facilitators and other authorized individuals may require a participant to make the request for records in writing. If requested records contain protected health information (PHI) of other participants, the facilitator or other individual who possesses the records must redact the PHI of all additional participants.

H. A facilitator must not disclose personally-identifiable confidential participant information when consulting with colleagues or with other participants.

I. Limits of confidentiality must be discussed with participants, including under what conditions confidential information is legally required to be released.

J. To the extent that a clinical facilitator has more stringent requirements for recordkeeping as a part of their secondary license, the clinical facilitator should maintain facilitation records consistent with the more stringent requirements of their secondary license.

6.5 Informed Consent

A. A facilitator must document the informed consent obtained from each participant, including decisions related to safety plan, physical touch, the presence of other individuals, the use of video recording, and other decisions that the facilitator deems necessary regarding the provision of Natural Medicine Services.

B. A facilitator must obtain informed consent from the participant before the initiation of every administration session using natural medicines.

C. A participant may withdraw their consent at any time. A facilitator must document the participant's withdrawal of consent within the record.

D. If a clinical facilitator holds a secondary license that requires the licensee to be a mandatory reporter, or if a facilitator is otherwise a mandatory reporter according to Colorado law, the facilitator or clinical facilitator must disclose to a prospective participant that they are a mandatory reporter, together with a description of their scope of required reporting.

E. A facilitator must inform a participant of the scope of natural medicine services that will occur as part of facilitation, including an accurate description of natural medicines used, potential risks and benefits, and alternatives to the use of natural medicine, prior to the administration session.

F. A facilitator must accurately represent their background and training using appropriate terms according to applicable laws and professional codes. A facilitator must disclose all licenses they hold and all professional domains they operate in.

G. A facilitator must inform a prospective participant of all fees and costs associated with their provision of natural medicine services, as well as their process for collecting payment, before delivering a billable service. This includes any third-party services that a facilitator uses to collect payment from a participant should they fail to pay a facilitator. If a facilitator works in association or connection with a healing center, the facilitator must also disclose all practices that the healing center uses to collect payment, including any third-party services. A facilitator must notify a prospective participant that, by using a third party to collect delinquent fees, a facilitator will disclose the identity of the prospective participant and indicate that they are a participant of the facilitator.

H. A facilitator must inform a participant and all persons present of any audio or video recording occurring during the use of natural medicines, including the preparation, administration, and integration sessions. A facilitator must describe the purpose of recording and how recordings will be stored and used. A facilitator must obtain informed consent from all persons present prior to recording sessions. A facilitator must obtain explicit permission, outlining the specific use, authorized recipient(s), and terms of release, from the participant and all identifiable persons before releasing audio or video recordings.

I. A facilitator must obtain informed consent for any physical touch that might be used during the administration session, in accordance with the requirements in Rule 6.6.

J. A facilitator must inform a participant in advance and, when possible, receive permission from the participant about the possible or scheduled presence of assistants, providers, observers, staff or anyone else who may be present during the provision of natural medicine services or have access to participant-identifying information.

K. A facilitator must inform a prospective participant regarding their process for termination of Natural Medicine Services as part of the informed consent process during an informal consultation or at a preparation session.

L. A facilitator must explain to a prospective participant in another state any risks associated with traveling to Colorado to receive natural medicine services.

6.6 Use of Physical Touch

A. A facilitator may provide supportive touch during administration sessions when requested by the participant and with the participant's written consent, which must be obtained during a preparation session using a physical touch contract.

B. A facilitator may use supportive touch, including the placing of the facilitator's hands on a participant's hands, feet, or shoulders, during an administration session. A facilitator may only use forms of touch for which they have received education and training and are within the bounds of their competence to use.

D. Participants participating in a group administration session may provide prior written consent to authorize supportive touch from other participants participating in the group administration session. A facilitator shall not permit another person to use any other form of touch during an administration session. A facilitator may decide not to allow participants to provide any form of supportive touch to other participants during group sessions, which must be documented on the physical touch contract.

E. A side from protecting a participant's body from imminent harm, including but not limited to catching them from falling, or to perform life-saving procedures, the use of touch is always optional, must be according to the consent of the participant, and must be limited to the administration session. If requested by the participant, a facilitator may demonstrate the scope of what may constitute supportive touch during a preparation session. A facilitator must inform a participant that there may be times a facilitator may need to make physical contact to ensure participant safety or the safety of other persons present, including but not limited to taking the participant's vital signs, walking a participant to the restroom, or preventing a fall while the participant is under the influence of natural medicine.

F. A facilitator must discuss with the participant in advance of the administration session simple and specific words and gestures the participant is willing to use to communicate about touch during administration sessions. For example, a participant may use the word "stop" or a hand gesture indicating stop, and the facilitator must stop touch.

G. A facilitator must practice discernment with physical touch, using their professional or clinical judgment and assessing their own motivation for physical touch when evaluating whether touching a participant is appropriate and consistent with the touch contract established between the facilitator and the participant through the informed consent process.

H. The use of physical touch that is outside the bounds of a facilitator's competence or that is used solely for the purpose of a facilitator's or participant's pleasure is never permitted.

I. The facilitator must document the scope of physical touch in a contract with the participant. The contract must include, but is not limited to:

1. A full and accurate description of any physical touch that the facilitator anticipates to be necessary during the administration session, including but not limited to physical contact to ensure participant safety;

2. The bodily areas, forms, frequency, and circumstances under which the participant consents to physical contact from the facilitator and any additional non-participant individuals who will be present during the administration session;

3. The words or physical gestures the participant will use to communicate their consent or revocation of consent to physical contact during the administration session;

4. Unless physical contact is initiated by a facilitator for the specific purpose of preventing harm to a participant during an administration session, all physical contact between a facilitator, a participant, and any other individuals present during the provision of Natural Medicine Services may only be initiated in accordance with the terms and conditions specified in the physical touch contract;

5. In addition to physical touch authorized by the physical touch contract, a facilitator or other authorized individual may initiate physical contact with a participant only if the facilitator or other authorized individual reasonably believes that such contact is necessary to prevent physical injury or harm to a participant; and

6. A participant may not give consent to physical contact during an administration session that is beyond the scope of the terms and conditions enumerated in the physical touch contract, or that goes beyond touch to hands, feet, and shoulders, only.

J. Notwithstanding the terms and conditions enumerated in the physical touch contact, a participant may refuse or revoke consent to physical contact at any time during the course of Natural Medicine Services.

6.7 When to Seek Emergency Services

A. A facilitator must utilize their training to distinguish between typical side effects of consuming natural medicines and medical emergencies. In the event of a medical emergency, a facilitator must contact emergency responders or other appropriate medical professionals immediately.

B. Facilitators who hold secondary licenses in a healing art must adhere to the strictest ethical standards of their dual professions while providing natural medicine services.

6.8 Discrimination and Exploitation Prohibited

A. During their performance of Natural Medicine Services, a facilitator must not discriminate or otherwise engage in behavior that is harassing or demeaning based on age, gender, gender identity, race, ethnicity, culture, national origin, religion, sexual orientation, disability, socioeconomic status, or any other basis proscribed by law.

B. A facilitator may not exploit persons over whom they have supervisory, evaluative, or other authority, including but not limited to participants, students, supervisees, research participants, and employees.

6.9 Provision of Natural Medicine Services to Subordinates Prohibited

A. A facilitator may not provide services to people over whom they have supervisory, evaluative, or other authority, including but not limited to students, supervisees, research participants, and employees.

1. Notwithstanding this prohibition, a training licensee who is engaged in practicum hours through an educational institution may receive natural medicine services from their practicum's supervising facilitator.

6.10. Sexual or Romantic Relationships and Conduct Prohibited

A. A facilitator may not engage in romantic or sexual relationships with students or supervisees who are in their department, agency, or training center or over whom the facilitator has or is likely to have evaluative authority.

B. A facilitator may not engage in any romantic relationships, sexual contact, or sexual intimacy with participants, or participants' partners, or their immediate family members, during natural medicine services and for a period of two years following the termination of Natural Medicine Services to the participant.

C. A facilitator may not offer or provide Natural Medicine Services as a means of establishing a personal relationship with a participant.

D. A facilitator with a dual license to practice another profession must be aware of the Practice Act governing that license and comply with all requirements related to dual relationships and provisions related to relationships with clients or patients in that profession.

6.11 Facilitator Health/State of Mind

A. A facilitator may not consume or otherwise be under the influence of natural medicine or any other intoxicant while providing Natural Medicine Services.

B. A facilitator must refrain from initiating Natural Medicine Services with a participant when they know or reasonably should know that there is a substantial likelihood that their own state of mind or physical condition will prevent them from performing their work-related activities in a competent manner.

1. When a facilitator becomes aware that their own state of mind or physical condition could interfere with their ability to perform their work adequately, the facilitator must take appropriate measures, including but not limited to obtaining professional consultation or assistance, and determine whether they should limit, suspend, or terminate their work.

C. A facilitator must identify when they are unable to provide appropriate care and must inform a participant that they must discontinue Natural Medicine Services and refer them to other providers as a result.

D. A facilitator must develop and document a plan in the event that they are unable to safely provide facilitation services to a participant, so that the participant may safely receive Natural Medicine Services from another facilitator or provider.

6.12 Financial Guidelines

A. A facilitator may not engage in any financial transactions with a participant, the participant's partners, or the participant's immediate family members that would violate the facilitator's duty of loyalty to the participant.

6.13 Facilitators holding Secondary Licensure

A. In conjunction with the provision of Natural Medicine Services, a facilitator or a clinical facilitator who holds a secondary license may also provide services pursuant to their secondary license, including but not limited to medical or behavioral health care, as long as the facilitator's or clinical facilitator's secondary license is active and in good standing, the services fall within the scope of their secondary license, and the secondary license has not been restricted to prevent the licensee from performing the service. The facilitator or clinical facilitator may only perform such medical or behavioral health services within the bounds of their competencies.

6.14 Establishing and Maintaining Continued Competency in Facilitation

A. A facilitator must practice within the bounds of competence, training, and experience specific to the populations they are working with and the modalities they offer.

B. In those emerging areas in which generally recognized standards for training do not yet exist, a facilitator takes reasonable steps to ensure the competence of their work and to protect participants, students, supervisees, research participants, organizational participants, and others from harm.

C. When indicated and professionally appropriate, a facilitator may collaborate with other professionals in order to serve their participants effectively and appropriately. At no time is a facilitator permitted to consult or collaborate with others on services that require licensure unless that individual possesses an active license for the services being consulted for or provided to participants.

D. A facilitator must receive ongoing professional development, through supervision, collaboration, or peer support groups and through continuing education to maintain or expand their competencies.

E. A facilitator must maintain licensure(s) in good standing for all services they offer, including renewal of facilitator and secondary licenses as required by Colorado law.

F. A facilitator must perform all administration sessions in person and within Colorado. If a facilitator provides preparation or integration sessions while a participant is physically located in another jurisdiction, the facilitator should avoid engaging in the unlicensed practice in another state of a licensed profession.

6.15 Initial Consultation or Informal Inquiry

A. Prior to the provision of Natural Medicine Services, a facilitator should undertake an initial consultation or informal inquiry with all prospective participants. The initial consultation should serve to identify whether a prospective participant is a potential candidate to receive Natural Medicine Services from the facilitator, as well as whether the prospective participant wishes to retain the selected facilitator to provide Natural Medicine Services. Nothing in this Rule 6.15 is intended to prevent individuals who are not licensed as facilitators, but who are affiliated with a facilitator or a healing center, from answering general questions from prospective participants.

1. A facilitator should begin their assessment during initial consultation whether a prospective participant's needs can be addressed within their bounds of competence, and if not, the facilitator may make informed referrals to other providers and services.

B. Screening Assessment: A facilitator must provide every prospective participant their written screening tool, and discuss with them the circumstances under which that prospective participant may or may not be an appropriate candidate for the provision of any Natural Medicine Services.

C. Disclosures: A facilitator must ensure adequate disclosure to prospective participants of all relevant considerations or factors that a prospective participant would need to know in order to make an informed decision regarding the selection of a facilitator for the provision of Natural Medicine Services.

1. Required Disclosures: A facilitator must provide the following disclosures:

a. Full and accurate written information regarding all licenses, registrations, or certificates the facilitator holds, including all active and inactive licenses, registrations, and certificates issued by this state; all licenses, registrations, or certificates, whether active or inactive, issued by another state, United States jurisdiction, or foreign country; any disciplinary actions taken against any license, registration, or certificate held by the facilitator; and all professional domains in which the facilitator operates.

b. Disclosures regarding costs, signed by the participant, which must include, at a minimum:

(1) A full and accurate written description of all costs charged to the participant and the process the facilitator or healing center will utilize for collecting payment before delivering Natural Medicine Services, including any third-party services that may be used to collect payment from a participant in the event of non-payment by the participant. If a third-party is to be utilized to collect payment, a facilitator shall disclose that in the case of non-payment, the identity of the participant and the fact that the individual is a participant in Natural Medicine Services provided by the facilitator will be disclosed to the third-party.

(2) The description of Natural Medicine Services costs required pursuant to Rule 6.3(B)(5) must include the full cost of Natural Medicine Services, including:

(a) The fee charged for each preparation session;

(b) The fee charged for each administration and integration session, including the cost of the natural medicine to be used during the administration session.

(i) A facilitator may not charge a separate fee for the first integration session.

(3) A full and accurate written description of any additional fees that may be imposed by the facilitator or healing center, including but not limited to, rescheduling fees and cancellation fees, as well as a description of the facilitator's or healing center's refund policy, including the circumstances under which a refund will be issued and a description of which costs are non-refundable.

(4) A full and accurate written description of the procedures to terminate services or otherwise transfer the participant's care that a facilitator or healing center will utilize if, after the initial screening process or following the preparation session, but prior to the commencement of the administration session, the facilitator determines that they are unable to provide Natural Medicine Services to the participant.

(a) If a facilitator is providing natural medicine services to a participant at a private residence, in addition to all other required disclosures, the facilitator shall disclose the following: the availability of licensed healing centers, the regulations applicable to healing centers, that healing center regulations do not apply to private residences; and the risks associated with receiving natural medicine services at a private residence and outside of a licensed healing center.

2. Pre-Administration Disclosures: A facilitator may provide additional disclosures during an initial consultation or informal inquiry. To the extent that such disclosures are not provided during an initial consultation or informal inquiry, a facilitator must provide the following disclosures during the preparation session, and must document within the participant's record that the facilitator provided the disclosures:

a. A facilitator must ensure that each participant receives all information necessary to give appropriate informed consent for Natural Medicine Services.

(1) As part of the informed consent process, a facilitator must discuss the process for termination of the Natural Medicine Services and the circumstances under which the Natural Medicine Services may be terminated at the discretion of the participant, by the facilitator, or due to unforeseen circumstances. At a minimum, the facilitator must explain the termination process in sufficient detail for the patient to give informed consent, and must identify an alternative facilitator who may provide Natural Medicine Services to the participant in the case the facilitator experiences an emergency and is unable to facilitate an administration session.

b. A facilitator must provide participants with clear, written information about the facilitator's availability for communication, the means of communication to be utilized, the availability of support services, and emergency contacts as part of the informed consent process.

c. Written disclosures regarding Natural Medicine Services, signed by the participant, and which must include, at a minimum:

(1) Information detailing the current state of medical and scientific knowledge with respect to the efficacy, safety, and the range of Natural Medicine Services outcomes that the prospective participant may reasonably expect from the receipt of Natural Medicine Services.

(2) A statement advising the prospective participant of the possibility of potential adverse interactions with the prospective participant's current medical conditions or medications, as applicable, and to seek appropriate medical advice prior to commencing any Natural Medicine Services.

(3) A clinical facilitator must provide to a prospective participant documentation describing the scope of practice allowed by the clinical facilitator's secondary license, and the conditions under which the clinical facilitator may engage in the practice of medicine, the practice of psychotherapy, or other practice authorized by their secondary license, as applicable, during the preparation session, administration session, integration session, or at any other point during the provision of Natural Medicine Services.

(4) Documentation containing an accurate description of the natural medicines that the facilitator will use during the administration session, including any labels, warnings, or other information provided to the facilitator by the manufacturer of the regulated natural medicine product, as applicable; and,

(5) Information regarding the potential utilization of alternate facilitators during any point in the provision of Natural Medicine Services, including the alternate facilitator's name and any other information requested by the participant. Any such alternate facilitators must be included in the physical touch contract entered into pursuant to Rules 6.6 and 6.16(D)(4).

d. A document, signed by the facilitator and participant, detailing the participant's discharge plan, including a safe transportation plan from the healing center or other facility as allowed pursuant to article 170 of title 12 and article 50 of title 44, C.R.S., following the completion of an administration session.

D. As part of the initial screening process, the facilitator must determine if the prospective participant wishes to receive services during a group administration session, and if so, the facilitator must disclose to the prospective participant the number of other participants that may be present at any such group administration session.

E. Prior to an administration session, a facilitator and a prospective participant, must sign a form attesting to the following:

1. The prospective participant has provided their complete and accurate health record to the facilitator;

2. The facilitator has provided to the prospective participant all identified risk factors based upon the prospective participant's self-disclosed health information, including an acknowledgment that the prospective participant has been fully informed of the risks of participating in Natural Medicine Services, that the participant acknowledges that the participant understands the stated risks, and that the participant has given their informed consent to the Natural Medicine Services in accordance with Rule 6.3(B)(2).

3. The facilitator understands and has documented in writing the prospective participant's reasons for seeking access to Natural Medicine Services and provided a full and accurate description of the Natural Medicine Services to be provided to the prospective participant; and

4. The facilitator and prospective participant have agreed to the circumstances and parameters of physical touch between the participant, the facilitator, and any other person, in accordance with Rule 6.3(B)(6), including but not limited to the requirement for ongoing informed consent to physical touch between the facilitator and participant, and the right of the participant to withdraw consent to physical touch.

F. In addition to any other disclosures required pursuant to article 170 of title 12, C.R.S., or these Rules, facilitators must provide the following information in writing to each participant prior to each preparation session, administration session, and integration session:

1. The name, address, and telephone number of the facilitator;

2. An explanation of the regulations applicable to the facilitator and to the facilitation of Natural Medicine Services;

3. A full and accurate description of the training, educational and experiential requirements the facilitator satisfied in order to obtain a license pursuant to these Rules and article 170 of title 12, C.R.S.;

4. A statement indicating that the facilitator is regulated by the Division, and an address and telephone number for the Division; and

5. A statement indicating that the participant is entitled to receive information about Natural Medicine Services, may terminate Natural Medicine Services at any time, and may terminate previously provided informed consent for physical touch at any time.

6.16 Requirements for Preparation Sessions

A. If an administration session is to be provided in a group setting, the facilitator must ensure that at least one associated preparation session is conducted individually with each participant who will be present during the group administration session.

B. Safety and Screening Assessment: If a facilitator has not conducted a thorough and comprehensive screening and assessment with every participant prior to the preparation session, the facilitatory must do so during the preparation session.

C. If a facilitator has not obtained any of the required or optional disclosures identified in Rule 6.15 prior to the preparation session, the facilitator must make those disclosures to the participant during a preparation session.

D. Prior to an administration session a facilitator must, as part of the informed consent process, fully inform the participant of the risks associated with taking natural medicines. Fully informed consent must include, at a minimum, information about the risks, benefits, and description of the range of possible outcomes from working with natural medicines in order for the participant to make an informed decision about whether to undertake the administration session. This must include the following:

1. A full and accurate description of the range of possible effects of natural medicines, how natural medicines alter the human state of consciousness, and how natural medicines may disrupt a participant's ability to make decisions or give or revoke consent;

2. A written statement that the participant has the right to request another non-participant individual, who may be a licensed facilitator, be present during an administration session. The statement must also notify the participant that they have a right to request to have a video recording taken of an administration session. A facilitator must allow both for a non-participant facilitator and for a video recording to be taken of their administration session, upon request from a participant. If a non-participant is to be present during the administration session and does not attend the preparation session, the participant must be allowed to meet the additional individual prior to the administration of natural medicine. If a facilitator is unable for any reason to meet the requirements of this subsection, they shall provide the participant with written referrals to other healing centers or facilitators, as appropriate.

a. A facilitator may, but is not required to, allow more than one additional, non-participant per participant (who is not a facilitator) to be present during an administration session. If the facilitator authorizes the participant to bring an additional individual, that person must attend some portion of the preparation session with the participant and must agree to the parameters of the physical touch contract.

3. A statement indicating the presence or potential presence of any other individuals during the provision of Natural Medicine Services and a disclosure of individuals who may have access to a participant's personally identifying information, including but not limited to assistants, licensed or unlicensed healthcare providers, observers, or any other healing center staff. In each instance in which a person covered by this subsection will be present during the course of Natural Medicine Services, the facilitator must obtain informed consent from the participant specific to each such additional person who will be present.

4. A physical touch contract signed by the facilitator, the participant, and any additional individuals who may or will be present during the administration session or at any other time during the provision of Natural Medicine Services, consistent with the requirements of Rule 6.3(B)(6).

F. Prior to or as part of the preparation session, the facilitator must perform a comprehensive screening of the participant, which must include but is not limited to the following:

1. Medical history. The facilitator must perform a safety assessment using a safety screening tool that reflects generally accepted standards of practice. If the facilitator's screening identifies risk factors that suggest the need for involvement of a medical or behavioral health provider, the facilitator may provide Natural Medicine Services if at least one of the following additional actions occurs:

a. A participant has received a direct referral for Natural Medicine Services;

b. A participant has been provided medical clearance by the participant's medical or behavioral health provider, or

c. The participant has engaged in a consultation and risk review with a medical or behavioral health provider.

(1) The provider may be licensed in Colorado or in the participant's state of residence, but must be licensed to diagnose and treat the participant's physical or behavioral health condition(s) identified as a risk factor(s) by the safety screening tool.

2. A thorough evaluation by the facilitator identifying any risk factors based on the medical information provided by the participant.

a. If the facilitator does not hold a clinical facilitator license, and a participant has a medical or behavioral health condition that requires management during the provision of Natural Medicine Services, the facilitator must refer the participant to a clinical facilitator who can treat such condition through the scope of their secondary license. In lieu of referral, the facilitator may obtain written clearance to provide Natural Medicine Services to a participant, from a medical or behavioral health care provider.

3. The facilitator and participant must discuss the participant's objectives for seeking Natural Medicine Services, and the facilitator must document within the participants record their goals. To the extent possible, the facilitator should discuss whether the participant's objectives can be reasonably met through the use of Natural Medicine Services.

4. If the participant has obtained a referral from a licensed healthcare professional for Natural Medicine Services which includes dosage instructions, the facilitator must not exceed the dosing amounts and should generally try to follow the dosing instructions included as part of any such order or referral, provided such dosing amounts and instructions do not violate any other parts of these rules.

G. A participant must attest that they have provided a complete and accurate medical history to the facilitator.

H. The facilitator must request demographic data from each participant. At the participant's discretion, the participant may disclose demographic data to the facilitator as part of the medical information provided to the facilitator.

I. The facilitator must maintain the following as part of each individual participant's records:

1. All disclosures obtained pursuant to Rule 6.15;

2. The fee agreement signed pursuant to Rule 6.3(B)(5).

3. The transportation plan signed pursuant to Rule 6.3(B)(4).

4. The informed consent agreement pursuant to Rule 6.3(B)(2), including the physical contact agreement signed pursuant to Rules 6.3(B)(6).

5. The date and the start and end time of each preparation session, administration session, and integration session.

6. The regulated natural medicine product consumed or ingested by the participant during each of the participant's administration sessions, including the unique identification number, if any, the amount of regulated natural medicine product consumed or ingested by the participant at each administration session, and whether the regulated natural medicine product was consumed or ingested in a single or over multiple doses during the same administration session.

7. A record of any participant reported outcomes (to the extent available) and adverse events that occur during an administration session and the nature and result of the facilitator's response to the adverse event.

J. If, following the initial screening and informed consent process, 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 a participant of their recommendation.

1. If the participant rejects the facilitator's recommendation pursuant to this paragraph (I), the facilitator may refuse to continue the provision of Natural Medicine Services to the participant and may refer the participant to another healing center or facilitator.

K. If the administration session will be conducted in an authorized location that is not a healing center, the facilitator must adhere to the following:

1. Prior to an administration session occurring in an authorized location other than a healing center, as part of the informed consent process, a facilitator must fully inform the participant of the risks associated with natural medicines and how those risks may be increased or changed if the participant chooses to participate in an administration session in an authorized location other than a healing center.

2. A facilitator may not conduct an administration session in an authorized location other than a healing center or healthcare facility if a participant refuses to authorize either another individual to be present during the administration session or a video recording of the administration session.

3. If the preparation session does not occur in person at the planned location for the administration session, the facilitator must inspect the proposed location for the administration session prior to such session, in order to assess for possible risks.

L. A facilitator may charge additional fees if a participant requests more than one preparation session.

6.17 Requirements for Administration Sessions

A. If a facilitator experiences an emergency situation that prohibits the facilitator from facilitating a scheduled administration session, the facilitator must:

1. Make all reasonable efforts to timely reschedule the administration session for the closest possible date and time during which the facilitator will be available for facilitation;

2. Engage the backup facilitator as identified as part of the informed consent process; or

3. Cancel the administration session and refer the participant to another facilitator or healing center.

B. A facilitator may only provide physical touch during an administration session at the request of the participant and only within the parameters set forth in the signed physical touch contract.

C. During an administration session, a facilitator must take 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 as well as psychological well-being, and take reasonable steps to prevent physical injury to a participant.

D. A facilitator must instruct a participant to not leave the administration space during an administration session and shall take all reasonable efforts to ensure that a participant follows instructions given to them by facilitators or other authorized healing center personnel.

E. A facilitator must restrict the movements of a participant during an administration session if such movements would endanger the physical or mental safety of the participant or any other individual present during the administration session, including the facilitator or other participant.

F. Dosage

1. A facilitator must determine the dosage that they will administer based on the screening of, and in consultation with, the participant. Any dosage of psilocybin administered must meet the generally accepted professional standards of practice.

a. For doses of under 10 milligrams of total psilocin, an administration session must last no fewer than three hours in duration and until the participant is showing no obvious adverse effects from natural medicine. A facilitator may extend the duration of an administration session beyond three hours, based on facilitator discretion or at the request of the participant.

b. For doses between 10 and 50 milligrams of total psilocin, an administration session must last no fewer than five hours in duration and until the participant is showing no obvious adverse effects from natural medicine. A facilitator may extend the duration of an administration session beyond five hours, based on facilitator discretion or at the request of the participant.

G. Additional requirements for group administration sessions

1. Administration sessions may be conducted in groups at the discretion of the facilitator.

2. Each participant who will be present during a group administration session must individually give informed consent to participate in a group administration session.

3. If a facilitator elects to conduct a group administration session, the facilitator must ensure that no more than 4 participants per facilitator are present during the group administration session.

a. A facilitator may not allow more than 64 participants to be present during a single administration session, regardless of the number of facilitators present.

4. A facilitator must not allow physical touch among anyone during a group administration session unless participants have consented to physical touch by the specific individuals in the session.

5. Everyone attending the administration session must be known to the participants prior to the beginning of the session.

6.18 Additional Requirements for Administration Sessions Outside of a Healing Center

A. A facilitator may facilitate an administration session in a location other than a healing center in accordance with these rules.

B. A facilitator may provide natural medicine services at a private residence only if at least one participant receiving natural medicine services from the facilitator at the private residence has a legal right to possess and occupy the premises as a residential dwelling.

C. A facilitator shall perform a reasonable review of the private residence to ensure it is appropriate for a proposed natural medicine administration session sometime prior to the commencement of the administration session, including ensuring that it is free from hazards, weapons, and uncontrolled animals.

D. No one under twenty-one years of age may be present at a natural medicine administration session at a private residence.

E. Regulated natural medicine product used at a private residence must be procured from the regulated market. Regulated natural medicine product used at a private residence must be transported and stored consistent with the Colorado Natural Medicine Code, §§ 44-50-101, C.R.S. et seq. Specifically, a facilitator must determine whether a separate license is required to transport natural medicine product to a private residence.

F. All statutory provisions and rules applicable to a facilitator providing Natural Medical Services outside of a healing center apply the same as to a facilitator providing Natural Medicine Services in a healing center except as otherwise expressly provided in these rules.

G. If a facilitator facilitates an administration session in an authorized location other than a healing center, the facilitator must require and provide for one of the following:

1. One or more additional facilitators to be present at all times during the administration session; or

2. A video recording of the administration session.

H. The participant must consent to the facilitator's proposed election for compliance with this requirement as part of the informed consent process during the preparation session.

I. A facilitator may not facilitate an administration session in a location other than a healing center if a participant does not consent, as part of the informed consent process, to the presence of other individuals or to video recording of the administration session.

J. Prior to and following the completion of an administration session in an authorized location other than a healing center, a facilitator must maintain custody of all unused regulated natural medicine product(s) and must return all unused regulated natural medicine product(s) to a Natural Medicine Business following completion of an administration session or secure any unused regulated natural medicine product(s) consistent with Colorado law.

6.19 Requirements for Integration Sessions

A. A facilitator may not charge a separate fee for the first integration session. If disclosed in advance, a facilitator may charge additional fees for additional integration sessions beyond the first session.

B. A facilitator must complete the following procedures as part of an integration session, including but not limited to:

1. The facilitator must conduct a thorough review of the administration session for which the integration session is being held with each participant who participated in the administration session.

2. The facilitator must evaluate the participant and their reaction to the regulated natural medicine product(s) ingested by the participant during the administration session and must recommend follow-up care and make referrals to other healthcare providers or facilitators as appropriate. The facilitator may recommend additional integration sessions.

C. A facilitator may facilitate a group integration session if each participant has given informed consent to participate in a group integration session as part of the informed consent process.

6.20 Rules for terminating services

A. A facilitator has a duty to identify if they are unable to provide Natural Medicine Services with an appropriate level of care with respect to a participant or participants and must terminate their provision of Natural Medicine Services in such circumstances.

1. A facilitator who terminates Natural Medicine Services in accordance with this paragraph (A) must refer each participant to whom the facilitator has agreed to provide Natural Medicine Services to another facilitator or healing center.

B. A facilitator must have a written protocol in place describing the specific process and procedures the facilitator will follow in the event of a termination of Natural Medicine Services.

C. A facilitator must terminate Natural Medicine Services for a participant if the facilitator reasonably believes that the participant is no longer benefitting from the Natural Medicine Services, is not likely to benefit from the continuation of Natural Medicine Services, or is being harmed by continued provision of Natural Medicine Services.

D. A facilitator may terminate Natural Medicine Services in the event the facilitator, in their reasonable judgment, has been threatened or otherwise endangered by a participant or another person with whom the participant has a relationship.

E. In the event a facilitator terminates Natural Medicine Services, the facilitator must refer the participant to another facilitator, health center, or health care provider, as appropriate. When providing referrals, including within or across state lines, referrals should be offered without the expectation of reciprocity or brokering, and should not involve the use of deceptive practices.

F. A facilitator must terminate Natural Medicine Services when a participant is no longer benefitting from the Natural Medicine Services when it becomes reasonably clear that a participant no longer needs the Natural Medicine Services, when a participant is not likely to benefit from the Natural Medicine Services, or when a participant is being harmed by continued Natural Medicine Services.

G. A facilitator may terminate Natural Medicine Services when threatened or otherwise endangered by a participant or another person with whom the participant has a relationship.

6.21 Rules Regarding Practice by Licensed Facilitators

A. Compliance with applicable law and these Rules. A facilitator is responsible for implementing and complying with all applicable statutory requirements and the provisions of these Rules.

B. License. A facilitator must ensure that the individual's license to practice as a facilitator is active and current prior to performing any acts requiring a license.

C. Documentation. A facilitator must keep and maintain such documentation as required by these rules and as necessary to discharge their duties and responsibilities in a safe and professional manner.

D. A facilitator must not provide Natural Medicine Services to a participant if the provision of such services involves a concurrent conflict of interest. A concurrent conflict of interest exists if there is a significant risk that the facilitator's ability to consider, recommend, or provide Natural Medicine Services will be materially limited as a result of the facilitator's other responsibilities or personal or professional interests.

E. A facilitator may not accept a fee or other benefit for making referrals to other facilitators, healing centers, or other health care professionals, and may not pay for other facilitators, healing centers, or other health care professionals for the making of referrals to the facilitator.

6.22 Data Collection

A. Basis and Purpose

Rule 6.22 is intended to establish requirements for all facilitators to collect and provide data to the Director upon request. Data collection is necessary to further the goals articulated in the Natural Medicine Health Act of 2022, including but not limited to the following expectations set forth in the Act: Board review of research related to the efficacy and regulation of natural medicine and natural medicine product, including recommendations related to product safety, harm reduction, and cultural responsibility (section 12-170-106(5)(b)), development of research related to the safety and efficacy of each natural medicine (section 12-170-106(5)(f)), current research, studies, and real-world data related to natural medicine to make recommendations as to whether natural medicine, natural medicine product, natural medicine services, and associated services should be covered under health first Colorado or other insurance programs as a cost-effective intervention for various mental health conditions (section 12-170-106(6)).

B. Authority

This rule is adopted pursuant to the authority in sections 12-20-204; 12-170-105(1)(a)(IV) and (V); 12-170-105(1)(j); 12-170-105(3), and 24-4-103, C.R.S.

C. Requirements for Data Collection

1. For each participant to whom a facilitator provides services, and for each administration of regulated natural medicine to the participant, each facilitator must collect and submit the following de-identified data:

a. A unique participant identification number;

b. Whether the services were provided in the Denver, Colorado Springs, or Grand Junction metro areas or a rural area. If services were provided in a rural area, whether the services were provided in Northeast, Northwest, Southeast, or Southwest Colorado;

c. Demographic information regarding the participant, including age, sex assigned at birth, gender identity, race/ethnicity; state of residence, veteran status; income range, and equity status;

d. Data from Risk Factor Screening Form;

e. Reasons the participant sought natural medicine services, including whether the participant had any diagnosed physical or behavioral health condition for which the participant sought natural medicine services;

f. Data from Mental Health Screening Form;

g. Fees charged for services, and if applicable, any discounts, scholarships, or other reduction in fees charged;

h. Whether the administration session was an individual or group session, the number of participants and whether the administration session took place outdoors, indoors, or both;

i. Whether the goal of facilitation was for clinical or experiential purposes (or both);

j. Confirmation of completion of the following records: touch contract, safety plan, transportation plan, and informed consent processes;

k. Data regarding the date and start and end times for every preparation, administration, and integration session;

l. Identification of the natural medicine products consumed by each participant, the unique identifier of the product, the amount consumed, and whether the consumption occurred in a single or multiple doses;

m. Whether the participant self-identified a benefit from the use of natural medicine and any other outcome-related information collected by the facilitator;

n. If known to the facilitator, whether an adverse health event occurred, and to the extent known, the date and time of onset, and duration and type of adverse health event; and

o. Whether a clinical facilitator provided services under a secondary license to the participant.

6.23 Requirements for Reporting Adverse Health Events

A. Statement of Basis and Purpose and Authority

The purpose of this Rule is to establish requirements for facilitators to report adverse health events to the Director.

The authority for this Rule is found in sections 12-20-404; 12-170-105(1)(a)(I), 12-170-105(1)(a)(II); 12-170-105(1)(a)(IV), and 12-170-105(1)(a)(V); 12-170-109; and 24-4-103, C.R.S.

B. A facilitator must report to the Director every adverse health event that is life-threatening or serious within 24 hours.

4 CCR 755-1-6

47 CR 11, June 10, 2024, effective 6/30/2024

47 CR 16, August 25, 2024, effective 9/14/2024