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Colorado Natural Medicine Advisory Bulletin 11.5: Rule Review & Roadmap

By Vicente LLP, Psychedelic Alpha

Jun 13, 2024

Vicente LLP is proud to collaborate with Psychedelic Alpha—an independent newsletter and community in the field of psychedelics—on the Colorado Natural Medicine Health Act Tracker, which includes high-level statistics, anticipated recommendations, and regularly published Natural Medicine Advisory Bulletins. The bulletins will provide updates from Natural Medicine Advisory Board meetings, along with other important information related to the implementation of the NMHA and psychedelics reform in Colorado.

Following the adoption of the Natural Medicine Advisory Board’s consolidated recommendations in January, Colorado regulators have been hard at work drafting, releasing, and revising substantive rules that will govern the state’s regulated Natural Medicine program. These rules are largely based on the Board’s recommendations, with regulators occasionally drawing on their own experience, or looking to Oregon to fill in gaps. Regulators have been responsive to public feedback, holding frequent stakeholder meetings and quickly updating rules in response to community concerns. A special thank you to Lorey Bratten, Dominique Mendiola, Allison Robinette, and all of the staff working to ensure regulations reflect the desire of Coloradans for safe, equitable, and accessible Natural Medicine in Colorado.

With regulators aiming to complete substantive rulemaking by August, the end of May roughly marks the halfway point of this process, and all of us participants are feeling the full effects. Regulators have released roughly 125 pages of proposed rules in no less than seven batches, each at a different stage in the rulemaking process, and most have seen at least one revision. We’re all feeling a bit disoriented, so let’s check-in.

In this article, we do a full-body scan of the state of Colorado’s Natural Medicine rules. We’ll mostly take a high-level inventory of which subjects have been addressed by rule, noting the status of those rules in the rulemaking process. Occasionally, we’ll discuss important rules in more detail to provide the most holistic view of how things are shaping up. In Part I, we provide context on the overall structure of the program and rulemaking process. Part II focuses on the practice of facilitation, including qualifications, licensing, and training programs. Part III focuses on Natural Medicine Businesses, which include Healing Centers, as well as testing, cultivation, and manufacturing. Finally, Part IV looks forward, noting anticipated rules and any lingering gaps. In each section, we’ve included relevant information on the rules’ status and next steps. 

I. So, Where Are We Now?

The Regulatory Framework

To orient ourselves in the rulemaking headspace, it may be helpful to ground our understanding in the overarching regulatory framework. At the highest level, Colorado’s regulated Natural Medicine program requires regulation of the facilitation profession, which includes training and licensing facilitators and overseeing training programs. Separately, regulators must license the operations of businesses necessary to support the profession of facilitation, such as businesses that will cultivate, manufacture, and test the Natural Medicine used in the program.

Administratively, licensing duties are divided between two regulatory agencies. The Department of Regulatory Agencies (“DORA”), a subdivision of the Division of Professions and Occupations, oversees the profession of facilitation. DORA-promulgated rules set standards for education, training programs, professional conduct, and disciplinary procedures.

The Department of Revenue (“DOR”) is tasked with overseeing Natural Medicine Businesses, which enable the profession of facilitation. Natural Medicine Businesses include the cultivation, manufacturing, and testing of Natural Medicine, as well as Healing Centers where facilitators will provide Natural Medicine Services.

The Rulemaking Process

A primer on rulemaking may also be helpful, as the process to stand up Colorado’s Natural Medicine Program involves multiple rulemaking proceedings, with rules at various stages in the process. “Rulemaking” refers to the official process by which proposed rules become enforceable regulations. The process formally begins when an agency publishes notice of permanent rulemaking, which indicates the rules under consideration and schedules a date for a final, permanent hearing. Before the final hearing, regulators must solicit public feedback to generate a reviewable record. Initial proposed rules may be modified before the permanent hearing, based on input from the public. The final hearing represents the last chance for public comment. Following the final hearing, the rules are reviewed by the head of the regulating agency, who may make minor adjustments for clarity and workability. Rules are then reviewed by the Attorney General, who verifies that the rules do not pose any constitutional issues or conflict with other state laws. If rules pass inspection by the Attorney General, they are essentially finalized and given an effective date.

DOR and DORA have chosen to conduct their rulemaking slightly differently, adding yet another layer of complexity. DORA has published three separate permanent rulemaking notices for three sets of rules. As a result, each batch of rules will be finalized and become effective at a different time. DOR has also chosen to release rules in batches. However, rather than individual notices and final hearings for each batch, all rules released by DOR are being considered in a single, expansive rulemaking proceeding. The primary effect of this difference in approach is that all rules promulgated by DOR are open to public comment and revision through the end of the rulemaking process. DORA’s rules, in contrast, will be closed to public comment on different dates. Both agencies expect to hold additional rulemaking proceedings to formally establish fee structures, following the finalization of substantive rules.

II. The Profession of Facilitation

DORA’s Office of Natural Medicine Licensure has released three sets of rules governing the profession of facilitation. The first set covers facilitator1 licensing, including qualifications and educational requirements, training program approval, facilitator scope of practice2, advertising of Natural Medicine Services, and disciplinary procedures. The second set primarily addresses standards of practice, with additional rules governing the advertising of Natural Medicine Services. The third and final set contains disciplinary procedures and defines the unlicensed practice of facilitation.

Facilitator License Types, Qualifications, Education, Experience, and Training Programs

  • Current Rules
  • Status: Finalized, effective June 30th, 2024. 
  • Public Comment: Closed.

Rules governing license types, qualifications, education, scope of practice, and training programs were originally released on February 23, 2024. Following initial public comment and revision, the final public comment was heard on May 3rd, 2024. On May 30th, the Colorado Attorney General signed off on these rules, making them the first official regulations of Colorado’s regulated Natural Medicine program. The rules go into effect on June 30th, 2024.

License Types

Draft rules define qualifications and licensing procedures for two full-scope licenses and two ancillary licenses. Full-scope licenses, which may provide Natural Medicine Services independently, include “Facilitator” and “Clinical Facilitator.” The Facilitator license is available to any individual who completes the education and experiential requirements. The Clinical Facilitator license is available to individuals who hold a valid Colorado license that permits diagnosing and treating behavioral health or physical health conditions.

Two ancillary licenses are also defined. A “Distinguished Educator” license, available to individuals with significant experience providing Natural Medicine Services, allows a licensee to provide Natural Medicine Services within the context of a training program. A Training license is available to individuals who complete the required 150 hours of didactic education and permits a licensee to charge for Natural Medicine Services provided during a supervised consultation period. Neither a Distinguished Educator or Training license is considered full-scope, meaning licensees may not provide Natural Medicine Services independently. 

Qualifications

All applicants must be over 21 and Basic Life Support certified. The rules do not explicitly prohibit an applicant from receiving licensure due to past criminal history, however, they do state that the director will assess applicants who have been convicted of “felony offenses against persons or property, or those involving fraud, dishonesty, moral turpitude, domestic violence, child/elder abuse, or drug diversion.” The Director may exercise discretion to approve applications with prior felony convictions.

Scope of Practice

Scope of Practice rules define when facilitators may provide Natural Medicine Services to certain participants, prescribe procedures for identifying risk factors, and define conditions that must be met before a facilitator may provide Natural Medicine Services when risk factors are identified. Both Facilitators and Clinical Facilitators must utilize a safety screening procedure to identify factors that may indicate an elevated risk when consuming Natural Medicine based on a participant's mental health, physical health, or medication regimen. When risk factors are identified, the facilitator must ensure the participant understands any risks before providing Natural Medicine Services. Rules prescribe when a third-party opinion is required before proceeding based on the type of risk and the facilitator’s secondary scope of practice. At the bottom, a participant may receive Natural Medicine Services from any facilitator of their choosing, provided they have consulted with an appropriate professional and have given their informed consent.

Education and Experience Requirements

As a baseline, all Facilitators and Clinical Facilitators must complete 150 hours of didactic education, 40 hours of supervised practice (practicum), and 50 hours of consultation. The 150 hour curriculum is broken into 14 required courses, with required topics prescribed by rule. Rules also set requirements for supervised practice hours, such as mandatory and permissible types of supervised practice, supervisor qualifications, distribution of hours, procedures for practicum sites, and the extent to which virtual and alternative training is permissible.

Educational Equivalence Pathways

Facilitators licensed in another jurisdiction may apply for licensure by endorsement, via an Occupational Credential Portability Program. Unlicensed applicants with experience providing Natural Medicine may also apply for accelerated licensure by petition, which grants exemptions from licensure requirements based on prior education and experience.

Approved Training Programs

Training programs must receive approval from the Director to ensure graduating students are eligible for licensure. Rules establish standards for the approval of programs, such as requirements for the organization and administration of the program. All programs are required to have a “named Director.” Director duties are defined in the rule and include ensuring compliance with regulations, liaising with the Office of Natural Medicine Licensure, maintaining documentation, and determining general policy for the program. Programs enrolling more than 50 students annually must have a “governing body.” Rules also establish the privileges of “approved” status and set minimum education standards, documentation requirements, enrollment limits, and faculty composition. Finally, rules establish procedures for application, denial, revocation, maintenance, reinstatement of “Approved” status, pre-approval of programs, and for student transfer between programs.

Standards of Practice & Advertising Limitations

Standards of Practice

This second set of rules codifies portions of the Facilitator Code of Ethics, as recommended by the Natural Medicine Advisory Board. The rules prescribe certain aspects of a facilitator’s conduct, including:

  • Required documentation and disclosures
  • Confidentiality and storage of participant records
  • Informed consent processes and disclosures
  • Permitted and prohibited use of physical touch
  • Prohibitions on discrimination and exploitation
  • Prohibitions on sexual, romantic, financial, or otherwise conflicting relationships with participants and participants’ immediate family
  • Prohibitions on accepting fees for referrals
  • Requirements around a Facilitators state of mind, including a prohibition on consuming Natural Medicine while providing Natural Medicine Services
  • Maintaining competency as a facilitator
  • Administration session duration, based on dosage

Rules also establish a facilitator’s responsibilities with regard to preparation, administration, and integration sessions, including group administration and integration. Notably, these rules permit administration outside of Healing Centers, as well as group administration. Additional rules regarding administration outside of licensed Healing Centers are anticipated, based on recommendations from the Natural Medicine Advisory Board.

Advertising

Rules regarding advertising of Natural Medicine Services prohibit false, misleading, or deceptive advertisements, as well as solicitation of testimonials.

Disciplinary Procedures & Unlicensed Practice

DORA’s third set of rules defines grounds for disciplinary action against a licensed facilitator, including certain felonies and misdemeanors, abuse of alcohol or controlled substances, violations of laws or regulations related to Natural Medicine, misrepresentation and deception, unprofessional or dishonest conduct, unlicensed practice of facilitation, aiding or abetting the unlicensed practice of facilitation, and failure to report certain required events. Licensees are required to report criminal convictions and any instance of unprofessional or dishonest conduct. “Unprofessional or dishonest conduct” encompasses crimes involving dishonesty or willful misrepresentation, crimes related to the practice of facilitation, and disciplinary actions taken against a facilitator by another jurisdiction or licensing board. 

III. Natural Medicine Businesses

As of May 31st, 2024, DOR’s Natural Medicine Division has released four sets of rules governing the operation of Natural Medicine Businesses. The first set of rules lays out the broad licensing framework for Natural Medicine Businesses, defines key terms, sets license qualifications, and establishes various administrative procedures. The second set of rules provides a baseline set of operational requirements which are broadly applicable to all licensed Natural Medicine Businesses. The third set of rules adds requirements unique to Healing Centers, while the fourth set governs advertising, packaging, labeling, and recordkeeping for the industry broadly.

Big picture, DOR has made a number of positive changes throughout the rulemaking process, based on community feedback. These changes include providing more flexibility for multi-use premises and small operators, permitting fresh fruit in administration sessions, and overall decreasing the regulatory burden for all operators. It’s important to note that all rules discussed below are proposed rules and are subject to change. The public can continue to provide feedback on all rules until July 25th, 2024 by submitting written comments or attending an upcoming rulemaking meeting.

Additional rules governing cultivation and manufacturing, testing protocols and facilities, and enforcement and disciplinary procedures are expected as part of DOR's initial rulemaking. Following the adoption of the initial rules, a second round of rulemaking to establish licensing and application fees is anticipated.

Licensing & Qualifications

Initial Application Requirements

All Natural Medicine Business license applications must include information regarding proposed business owners, disclose certain financial interests, provide general premises information, and show proof of compliance with local and state laws. Additional disclosure rules apply when a proposed owner is an entity. Applicants must also submit documentation of Environmental Social, and Governance (“ESG”) criteria. Current proposed rules limit possible methods of compliance with the ESG requirements to a set list of options prescribed by rule.3 Rules provide for priority review of applications, including applications where one or more owners are veterans, have a “traditional, tribal, or Indigenous history with Natural Medicine,” or where the business will be located outside of the ten most populous counties in Colorado.

Applications for Healing Centers are additionally required to include information demonstrating a business relationship with a facilitator and information on any outdoor administration areas. Additional application requirements for Cultivation, Manufacturing, and Testing businesses are anticipated.

Natural Medicine Businesses: License Qualifications

All owners of a Natural Medicine Business that are natural persons must be over the age of twenty-one, current on taxes related to Natural Medicine Businesses, and free of convictions in the past three years that involve certain crimes, including those of violent, sexual, or fraudulent nature. Crimes related to Natural Medicine occurring after 2023 are also grounds for disqualification.

Individual Licenses

Owners of Natural Medicine Businesses must obtain an Owner License and must disclose certain financial interests. Individuals who directly handle Natural Medicine or who have unrestricted access to Natural Medicine are required to obtain a Natural Medicine Handler License. Notably, this includes any Facilitator who may handle Natural Medicine at a Healing Center. Rules establish qualifications and requirements for Owner and Natural Medicine Handler licenses.

Licensing Procedures

Proposed rules provide procedures for renewal, denial, reinstatement, voluntary surrender, revocation, and administrative appeal regarding licenses and applications. Natural Medicine Businesses must follow certain rules in the event of a change in ownership or business location to maintain licensure. The rules also set ownership composition requirements and penalties for noncompliance.

Disclosure of Financial Interests

Colorado statute prohibits a natural person or entity from holding a financial interest in more than five Natural Medicine Business licenses. Proposed rules require disclosure of certain interests, but do not clearly define when an interest is a prohibited financial interest.

Operation of Natural Medicine Businesses

Key to understanding many operational rules governing Natural Medicine Businesses are the different physical locations that make up a Natural Medicine Business. A “Licensed Premises” is, essentially, the entire licensed area of the business. A “Restricted Area” is an area where Natural Medicine will be stored, cultivated, manufactured, or tested. An “Administration Area” is a location within the Licensed Premises of a Healing Center where Natural Medicine will be administered to participants. All Natural Medicine Businesses will have Licensed Premises, while only Healing Centers will have Administration Areas. Except for Healing Centers storing small amounts of regulated products, all Natural Medicine Businesses are required to have a Restricted Area.

General Restrictions

All Natural Medicine licensees are prohibited from consuming Natural Medicine on Licensed Premises, except as a participant in an Administration Session.5 Healing Centers are permitted to use Administration Areas for other purposes when administration is not occurring. Additionally, Natural Medicine Businesses must verify that individuals handling Natural Medicine possess a valid Natural Medicine Handler license.

Business Records

Proposed rules require the storage of certain records, such as facility information, surveillance logs, visitor logs, security protocols, waste disposal, application information, hazardous materials, owner and employee lists, and adverse health events. The rules also prescribe where records may be stored, methods of access, and length of record retention.

Required Reporting

All Natural Medicine Businesses must report certain events, including adverse health events and crimes related to Licensed Premises or Natural Medicine. Healing Centers are additionally required to report medical and emergency incidents that occur on their premises, as well as deaths occurring within 30 days of receiving Natural Medicine Services.

Co-Location

Co-location of Natural Medicine Businesses with healthcare facilities and other Natural Medicine Businesses is permitted, subject to certain restrictions. Rules specify the treatment of Restricted Areas and Administration Areas in co-located premises. Per statute, Natural Medicine Businesses may not be co-located with alcohol or marijuana businesses.6

Security and Surveillance

General rules require all Natural Medicine Businesses to take adequate measures to prevent unauthorized access to records and Natural Medicine, such as locking and monitoring exterior entrances. Additional rules set minimum standards for alarm systems and surveillance equipment, as well as placement and coverage of cameras, maintenance of equipment, and protocols for storage and access of surveillance recordings.

Safety and Sanitation

Proposed rules include general sanitary requirements and waste disposal procedures. Rules also provide protocols for voluntary recalls and regulatory embargos of potentially dangerous products. 

Marketing, Packaging, Labeling, Storage, and Transport

Marketing and Advertising

Draft rules limit the audiences and content of advertisements for Natural Medicine Businesses. Advertisements may not target persons who may not legally obtain Natural Medicine Services, including individuals under 21. Additionally, advertisements may not be deceptive or appropriate, exploit Indigenous cultures or people, or make safety claims based on the fact that a product has been tested. Natural Medicine Businesses must also maintain audience composition data to ensure advertisements do not target audiences under 21.

Packaging and Labeling

Packaging and labeling rules are intended to prevent Natural Medicine products from appealing to children, ensure accurate inventory tracking, and facilitate accurate dosing of Natural Medicine. All Natural Medicine must be packaged and labeled prior to transfer to another licensed Natural Medicine Business. Specific rules vary depending on the transferring and receiving Natural Medicine Business types.

Storage, Transport, and Transfer

Natural Medicine Businesses are required to store Natural Medicine in a “Restricted Area,” with some exceptions. Restricted areas must be designated, clearly marked, and accessible only to licensed Owners and Natural Medicine Handlers. Rules also prescribe procedures for the transport and transfer of Regulated Natural Medicine, Regulated Natural Medicine Products, and Regulated Natural Medicine Waste.

Healing Centers

In addition to rules generally applicable to all Natural Medicine Businesses, DOR has released rules specific to the operation of Healing Centers. Following significant public feedback evidencing a need for regulations to differentiate between businesses operating as Healing Centers full-time and solo practitioners or small businesses, DOR amended the latest rules to distinguish between Healing Centers storing more or less than 750 mg of total psilocin and psilocybin across all regulated products. This critical distinction ensures that small businesses, such as therapists offering Natural Medicine Services occasionally, as part of their existing practice, are not subject to unnecessary and expensive security regulations.

Security and Surveillance

Healing Center licensees permitted to store 750 mg or less of regulated products are exempted from some of the substantial security requirements applicable to Natural Medicine Businesses generally, such as an alarm system and robust video surveillance systems. Licensees falling within this exception must store regulated products in a manner that is only accessible to licensed individuals and is monitored by video surveillance only when regulated products are present.

Administration Areas & Administration Sessions

Healing Centers must display certain information clearly in Administration Areas. Rules limit who may be present during an Administration Session and prescribe procedures for handling, preparing, and dispensing Natural Medicine. Participants are permitted to bring prepackaged food, including fresh fruit and vegetables. Healing Centers may provide prepared food following administration sessions, provided the Center complies with all related state and local rules.

Recordkeeping

In addition to the records required of all Natural Medicine Businesses, Healing Centers must maintain documentation about each Administration Session, such as the date and time, duration, disposed-of Natural Medicine, and de-identified data related to the participant’s reasons for seeking Natural Medicine Services. Additionally, Healing Centers must keep records of the licenses of individuals providing Natural Medicine Services at the Healing Center, as well as Standard Operating Procedures related to Administration Sessions and Emergency Plans.

IV. Anticipated Rules

Residential Facilitation and Other Authorized Locations

One of the trickiest and longest-running questions for Colorado’s Natural Medicine program is how facilitation outside of Healing Centers will function. One complicating factor is that the topic does not fall neatly within a single agency’s purview. Current facilitation rules permit facilitation at “other authorized locations,” which have yet to be defined. Defining “other authorized locations,” which could arguably be either DOR or DORA’s job, is only one part of the equation. Facilitators may need additional training to safely provide Natural Medicine Services in unfamiliar locations, which could require DORA to update education requirements. DOR has indicated it is prepared to license any location that meets the requirements of a Healing Center, however there is no indication DOR will authorize locations that do not meet these requirements. Thus far, DOR has been receptive to public feedback encouraging rules permitting multi-use spaces, however locations are still required to be licensed as a Healing Center, which is unrealistic for private residences.

On May 10th, the Natural Medicine Advisory Board’s combined subcommittee considered the issue. Without making any specific recommendations, the Board concluded that any rules allowing facilitation outside of Healing Centers must protect participant confidentiality. The Board also felt that unsupervised pets and children should not be permitted in a home while an Administration Session is occurring. The Board will continue to work on this question in June. Allowing Natural Medicine Services outside of established Healing Centers is crucial to ensuring care is both affordable and accessible to individuals who cannot travel to a Healing Center. Hopefully, regulators will be able to collaborate on a solution that balances safety with the principles of the Natural Medicine Health Act to ensure access for those most in need.

Cultivation, Manufacturing, Testing, and Enforcement of Natural Medicine Business Regulations

Current gaps in DOR’s rules include rules related to cultivation, manufacturing, and testing businesses, as well as enforcement and disciplinary rules for all Natural Medicine Businesses. DOR has a clear plan to address each of these areas over the coming weeks, with four additional rule-making meetings scheduled before the final hearing on July 25th, 2024.  On June 12th, DOR will hold an all-day meeting on cultivation and manufacturing, with draft rules anticipated on June 5th. Testing procedures and testing facilities will be addressed at the Department’s June 25th meeting, with draft rules anticipated June 18th. Enforcement and Disciplinary rules will be discussed on July 1st. Finally, DOR will hold an all-day “Catch-All” meeting on July 9th to revisit any subjects requiring further attention and address additional subjects that may not have been covered by previous meetings.

To participate in a rulemaking meeting related to any of the above subjects, visit the Division of Natural Medicine’s rulemaking webpage.

Fees

DORA and DOR will each separately set fees for the practice of facilitation and Natural Medicine Businesses, respectively. The final substantive rules will inform the overall cost of administering the program, which will be reflected in the fee structure. Fees related to Natural Medicine Businesses are scheduled for discussion at DOR’s July 9th rulemaking hearing and will be formally established during a second round of rulemaking. DORA has not indicated when or how it will establish fees for facilitators and training programs.

Data Collection

While rules from both DOR and DORA require some basic data collection, the full extent of data collection and reporting remains up for debate. Regulators, the NMAB, and the public generally agree that de-identified data allowing basic reporting on the state of the Natural Medicine program is both necessary and beneficial. However, perspectives diverge on the extent to which specific data points should be requested or required. As many have pointed out, Colorado is uniquely positioned to collect data on the efficacy of Natural Medicine. On the other hand, questions about privacy and security, as well as fears about potential abuses of data have given some members of the community pause when considering a more comprehensive data collection and reporting regime. Hopefully, regulators can strike a balance that makes participants feel safe while also contributing to the scientific and social understanding of the benefits of Natural Medicine.

Upcoming Public Engagement Opportunities

As formal rulemaking progresses, the public is encouraged to provide feedback to regulators through written comments and oral testimony. For the latest on facilitation-related rules, visit DORA’s Natural Medicine page and check the “Public Notice” section. For the latest on rules related to Natural Medicine Businesses, visit DOR’s rulemaking page. As always, stay tuned to our Natural Medicine Advisory Bulletin for the latest news on Colorado’s Natural Medicine program, as well as upcoming opportunities to get involved.

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Psychedelic Alpha's Colorado Natural Medicine Health Act Tracker webpage and bulletins are dedicated to being a clearinghouse for the implementation of Colorado’s Natural Medicine Health Act, with a focus on the work of the Natural Medicine Advisory Board and its subcommittees.  

Colorado Natural Medicine Advisory Bulletin #11: March & April 2024 | Vicente LLP

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