Written by Jeff Fitzgerald and Vicente LLP as part of our Colorado Natural Medicine Health Act Tracker.
Coming into the sixth month of work, Colorado’s regulated natural medicine program is starting to take shape. Answers to big-picture questions – such as what the scope of practice for a licensed facilitator is, and whether Indigenous practitioners can be compensated under the ceremonial use exemption – have begun to emerge from the collective consciousness of the Board and the broader psychedelic community. The subcommittees are meeting with experts and integrating their knowledge. With rulemaking set to begin in early 2024, the NMAB seems to be on track for their first major deadline – presenting initial draft recommendations on October 20th, 2023. Their suggestions will take a range of forms, from best practices to proposed regulatory rules and recommendations of new legislation to the General Assembly.
Additionally, the Department of Revenue has completed its first round of Listening Sessions, which represented the first opportunity for involvement of the public at large since the voters of the state passed Proposition-122 in November of 2022.
Having dissolved one subcommittee in August, the remaining five subcommittees and the full Natural Medicine Advisory Board met in September. A lot has happened and the pace is only picking up. Read on for a hefty dose of natural medicine… advisory board activity.
The Indigenous and Religious Use and Outreach subcommittee welcomed several new non-voting participants: Dr. Cheo Torres, professor of Mexican traditional medicine at the University of New Mexico; Veronica Lightning Horse Perez, a therapist and natural medicine practitioner; Dr. Mario Del Angel Guevara, a professor studying curanderismo at the University of New Mexico; and Sean McAllister, an attorney in the drug policy space who was involved in drafting the original Natural Medicine Health Act.
The subcommittee has crystallized around three main positions in recent meetings. First, they feel that Indigenous practitioners should be permitted to be compensated for work they do under the bona fide cultural exemption in C.R.S. § 12-170-108(4)1. Second, they feel that experienced facilitators should be able to get licensed without being required to complete the training prescribed by the NMAB. Third, and more broadly, the subcommittee is unified in calling for more input from native tribes and Indigenous communities on the overall work of the Board. To that end, DORA Natural Medicine Program Director Sam Bahrami has been meeting with tribal leaders around Colorado in hopes of bringing those perspectives into the conversations of the various subcommittees.
Several related subjects were discussed, such as the need for test-out options, possible methods of licensure through equivalency, removing barriers to education, and historical bias in education and testing. None were adopted definitively as recommendations.
Next meeting: October 13th, 2023 at 1pm MST.
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Following the dissolution of the Harm Reduction and Public Safety subcommittee, Dr. Tina Gonzales, Commissioner Wendy Buxton-Andrade, Ricardo Baca, and newly-minted NMAB member Stacie Loucks have joined the Emergency Response, Safety, and Ethics subcommittee.
Sam Bourdon of the Colorado Department of Public Health and Environment (CDPHE) gave a brief presentation on the Harm Reduction Grant Program, which funds grassroots harm reduction projects across the state. While the grant program is primarily focused on the opioid crisis, the subcommittee discussed incorporating psychedelic harm reduction into the program.
Turning to the larger issue of regulating administration of natural medicine outside of a healing center or licensed premises, there was some confusion amongst both NMAB members and non-voting participants about what exactly is sought to be regulated. Working through the uncertainty, the subcommittee identified several categories of location in which they expect facilitation to occur: outdoors (on private property), at a participant’s home, hospices, and hospitals. Rather than attempt a comprehensive set of regulations, the subcommittee will likely recommend a set of best practices. For example, knowing how to contact emergency services wherever a facilitator is providing natural medicine services.
Dr. Bradley Conner introduced a revised Natural Medicine Facilitator Code of Ethics in this meeting. Incorporating feedback from August’s meetings, the latest version permits a facilitator or participant to request either a second person be present during an administration session, or that the session be recorded. If a facilitator cannot accommodate the request, they would be required to refer a participant to a facilitator or healing center that can. Previous versions required a second presence or video recording. The latest version also specifically prohibits facilitator consumption of natural medicine during administration sessions. This prohibition would not apply to natural medicine ceremonies conducted under the bona fide ceremony exemption. Recognizing that some facilitators may practice in the regulated space and under the bona fide cultural exception, Dr. Bradley Conner will amend the ethical code to require a facilitator clearly delineate when they are operating under the regulated framework or the bona fide exception. The final version of the ethical code will need to be adapted into regulation via rulemaking to be enforceable.
Also of note in this meeting, DOR representative Allison Robinette indicated that a facilitator operating out of their own residence would likely need to have the residence licensed as a healing center. This is to avoid a loophole whereby the healing center license requirement can be circumvented.
As next steps, Dr. Alisa Hannum will draft a set of best practices for facilitation outside of healing centers and Dr. Bradley Conner will draft a definition of “other authorized locations” as well as update the ethical code.
Next meeting: October 11th, 2023 at 1pm MST.
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The Public Health and Health Equity subcommittee spent the bulk of their September meeting discussing a list of potential equity-related initiatives they have generated. The suggestions are grouped by subject matter relating to Indigenous & religious use, facilitators, participants, and the natural medicine industry broadly. A recurring theme for the subcommittee in recent months has been funding and September was no different. The cash-fund nature of the program, which requires that all direct and indirect costs of the program be covered by fees generated through licensing, has led to the subcommittee feeling the need for a tax funding mechanism similar to the tax which funds the Cannabis Business Office and its social equity programs. In Colorado, any new tax must be approved by voters per the Taxpayer’s Bill of Rights (TABOR).
In the Indigenous and Religious Use area, the primary suggestion is to allow compensation for ceremonial use under the bona fide ceremony exception, in line with the desires of that subcommittee. This suggestion will likely take the form of a recommendation that the General Assembly pass a change to the statutory language. Legislation is needed because any rules promulgated by DORA to allow remuneration under the exception would not protect practitioners from criminal liability under the criminal code.2
Turning to facilitators, suggestions included social equity licenses, variable licensing costs related to median incomes for certain professions, mentorship programs, free state-run facilitator training, licensure by endorsement, collaborative efforts with local colleges and students, and ensuring facilitators may operate independently of healing centers.
On the subject of participants, suggestions included unifying various harm reduction efforts, an annual report on equity in the Natural Medicine space, and encouraging HCPF3 to cover psychotherapy services when provided in conjunction with natural medicine. Rochelle Galey pointed out that per Colorado regulations, if a mental health provider receives public funds (such as Medicaid reimbursements), they must be licensed by the Behavioral Health Administration (BHA). This could be problematic because the BHA imposes its own licensing requirements such as data collection, fire inspections, and specific record keeping.4 This would likely be a non-issue for existing mental health facilities, however any new entrants providing mental health care could be subjected to a second set of regulations in order to receive Medicaid reimbursements. Also suggested is a sales tax on natural medicine that would go to Indigenous and Religious purposes, environmental issues, and equity initiatives.
Suggestions for the natural medicine industry as a whole were to ensure Indigenous and under-represented groups are represented in decision making broadly, creation of an equity rubric to guide decision making, data collection with an eye towards encouraging insurers to enter the market, green waste disposal practices, a psychedelics research working group, and payment plan options for license fees.
The last set of suggestions, focusing on healing centers, was discussed heavily. The common thread was the question of whether a facilitator can operate independently of a healing center. An underlying assumption of many board members has been that a facilitator is not required to have a relationship with a healing center, however through the discussion it was identified that the current statutory language does not permit a cultivator to transfer natural medicine to a facilitator directly. Brian Urankar of the Attorney General’s office believes this gap to be unintentional and advised the subcommittee to recommend a statutory change to the General Assembly. Regardless of statutory change, a Facilitator should still be able to acquire natural medicine from a Healing Center.
The subcommittee also briefly discussed the need to identify when facilitation would be more appropriate at a healing center – such as when heightened security requirements would be desirable.
Next meeting: October 12, 2023 at 1pm MST.
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The September meeting of the Products, Research, and Data subcommittee welcomed several new non-voting participants. Gerad Hansen is the sole proprietor of Uptown Fungus, a licensed cultivator in Oregon. Heather Krug is the Regulatory Programs Branch Chief for the State Public Health Laboratory, housed within CDPHE. Dr. David Caha is the managing director of Ad Science Lab. Dan Huson is the founder of Rose City Labs in Portland Oregon, a licensed testing facility under Oregon’s Psilocybin Services program. Brandon Jeffrey stood in for Kyle Lambert and Davis Grant as the representative from Colorado’s Marijuana Enforcement Division.
The bulk of the meeting was spent on two Q&A sessions. First, the subcommittee spoke with Gerad Hansen regarding his experience cultivating under Oregon’s Psilocybin Services program. Subcommittee members inquired about security requirements, testing requirements and costs, wholesale prices for psilocybin, waste disposal, packaging, substrates, transportation of psilocybin products, inventory tracking, costs related to cultivation, and difficulties with Oregon regulations. Mr. Hansen regarded some aspects of Oregon’s requirements, such as monthly speciation testing and 24-hour harvest batch requirements, as unhelpful and cost-inflating.
The next Q&A session with Dan Huson of Rose City Labs focused on testing. Rose City Labs is a general purpose lab conducting cannabis, food, and water testing in addition to psilocybin. Questions from the subcommittee covered testing requirements under Oregon Health Authority regulations, testing costs, methodology development, security, waste disposal, and security. Mr. Huson believes that regular testing should cover potency with random tests for species, heavy metals, and pesticides. According to Mr. Huson, operating as a psilocybin-only lab would not be financially viable in Oregon. Discussing variation in test results between labs, he encouraged the subcommittee to standardize sample preparation methods, allow for round-robin testing and proficiency testing, and encourage R&D of potency testing methods.
Discussing the USDA’s Mushroom Good Agricultural Practices, several NMAB members agreed that so long as testing requirements are satisfied, imposing the guidelines as regulations would be overly burdensome for small cultivators. For the purposes of the discussion, the subcommittee considered a cultivation business with less than five employees to be a small operation. The discussion then turned to the need for regulation broadly. Multiple non-voting participants as well as several NMAB members agreed that regulating specific cultivation procedures for cleanliness would be superfluous. This was due to the fact that, if accepted best practices are not voluntarily followed, a cultivator will simply fail to produce mushrooms. Broadly, the subcommittee coalesced around relying on the nature of mushroom cultivation plus testing as proxies for regulating cultivation procedures to the extent possible. There was also consensus that more regulations make sense for larger cultivation operations. Allison Robinette of DOR pointed out that the more complex the regime the higher the cost burden of compliance. She also stated that there are no requirements around how regulations must be structured or enforced. Thus a low-cost enforcement mechanism such as a signed affidavit promising to follow best practices could substitute for individual facility inspections.
One large question for the subcommittee is what types and methods of extractions will be permitted. Under Colorado statute, extractions may not include “a derivative of a naturally occurring compound of natural medicine that is produced using chemical synthesis, chemical modification, or chemical conversion.” 6 Dan Huson shared his opinion that extracting should be subject to tighter regulation, such as food safety standards, based on his experiences finding human hair and skin cells in tested extractions.
Lastly, the subcommittee briefly reviewed Lundy’s latest equity suggestions as they apply to cultivators. In a brief discussion, the Attorney General’s office and DOR established that social equity programs will likely require funding through taxes which will in turn require a tax bill in compliance with TABOR. The subcommittee will formulate questions for DOR tax experts who will join a full NMAB meeting in the future.
As next steps Dr. Bradley Conner will draft the following recommendations for the subcommittee to review:
- USDA Mushroom Good Agricultural Practices are suggested best practices for small cultivators.
- USDA Mushroom Good Agricultural Practices are required to some extent for large cultivators.
- Extraction processes must meet relevant food safety standards.
- A water source test will be required prior to licensing of a cultivation facility.
Next meeting: October 18th at 1pm MST.
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One new non-voting participant was introduced in the September meeting of the Qualifications, Licensing, and Training subcommittee. The new participant, Luke Priel, is a former facilitator trained in Indigenous practices.
First on the agenda was a presentation by Hadas Alterman on the American Psychedelic Practitioners Association’s Professional Practice Guidelines for Psychedelic Assisted Therapy. These 12 guidelines, published in August 2023, are claimed to be the first comprehensive set of professional practice guidelines (PPGs) for psychedelic-assisted therapy (P-AT). A seven-member working group from the APPA and BrainFutures developed the guidelines over 10 meetings. The goals of the guidelines are to 1) guide clinical practice 2) define standards of training through core competencies and 3) develop an accreditation program for P-AT training programs. The guidelines were developed with the US medical access pathway in mind, however Ms. Alterman stated that substituting “psychological support” for “psychedelic-assisted therapy” would make the guidelines applicable to a supported adult-use pathway like Colorado’s regulated natural medicine program. The intended audience at this time is regulators, insurance payors, boards like the NMAB developing qualifications for training and certification, training programs, and educators. The current PPGs address broad practice areas and the APPA is developing more specific ethical guidelines. Next steps will be publication in peer-reviewed literature, stakeholder discussions, development of core competencies for accreditation, and development of specific Clinical Practice Guidelines. The guidelines are held under a Creative Commons copyright that allows non-commercial non-derivative use, granting the APPA and BrainFutures the exclusive privilege of modification.
The true meat of the meeting was in the latest revision of the licensing model which includes a scope of practice for facilitators. Leaving aside questions of federal law, Dr. Alisa Hannum began by identifying potential problems for facilitators at the state level. The primary concerns are:
- A facilitator operating solely under the facilitator license is at risk for unlicensed practice of medicine or psychotherapy if facilitation looks too much like that other profession.
- A facilitator operating with additional licenses, for example a medical license, could be disciplined by that professional board if providing natural medicine services violates that board’s regulations.
Under the revised spheres model, the key differentiator between licensing spheres is holding a license with independent diagnosing and treatment authority. The model now calls for 3 types of licenses:
- Wellness Natural Medicine Facilitator
- Natural Medicine Psychotherapy Facilitator
- Natural Medicine Medical Facilitator
A “Licensed Wellness Natural Medicine Facilitator” may provide natural medicine services but is explicitly prohibited from practicing medicine7 or psychotherapy8 as defined in the practice acts of those professions. A “Dual Licensed Wellness Natural Medicine Facilitator” may provide other non-medical, non-psychotherapy services they are licensed by the state to provide in conjunction with natural medicine services.
A “Licensed Natural Medicine Psychotherapy Facilitator” would be permitted to provide psychotherapy in conjunction with natural medicine services provided they hold an appropriate psychotherapy license.9 Holders of this license may not independently practice medicine or provide natural medicine services to persons with cardiovascular risk factors, diseases of the liver, seizure disorders, or life-threatening illness unless referred by someone licensed to diagnose and treat those conditions. Students working under the supervision of a Licensed Natural Medicine Psychotherapy Facilitator would be allowed to provide natural medicine services. The suggested scope of practice allows registered psychotherapists to apply for this license “if appropriate”.
A “Licensed Natural Medicine Medical Facilitator” would be allowed to provide medical services in conjunction with natural medicine services provided they hold an MD, DO, PA, or NP degree.
Part of the motivation in defining these scopes is to ensure any complaints about facilitators are handled by a Natural Medicine regulatory board and not the boards of other professions. All license types would be required to complete Basic Life Support certification, DORA-mandated Facilitator training, and 40 hours of supervised practicum training. The requirements may be modified if an applicant meets criteria for accelerated training.
Citing the examples of forced hysterectomies and the DSM’s historical classification of homosexuality as a diagnosable mental disorder, Dr. Clarissa Pinkola-Estés pointed out that Western models of diagnosis should be taken with a grain of salt. She advised allowing for differential diagnosis and not requiring strict adherence to prior diagnoses.
Next, the subcommittee discussed training program requirements. Stating a desire to allow training programs to provide training in both Oregon and Colorado and recognizing certain statutorily mandated categories of training, Dr. Hannum presented a draft curriculum that reorganizes much of the Oregon requirements into the framework required by Colorado statute.10 Total hour requirements were briefly discussed without any conclusions.
Non-voting participant James Eshlemen presented a version of the Oregon program with several additions. He emphasized the need for three additional training modules specifically: 1) Inner Genius development; 2) Soft Skills; and 3) Self Care. Several NMAB members found these to be important additions, particularly the need for scenario-based training to prepare facilitators for difficult and unexpected experiences. Another point emphasized was the need for facilitators to recognize when they are not in the correct mental or spiritual space to facilitate.
Non-voting participant Dr. Shannon Hughes briefly presented an outline of possible practicum requirements. The subcommittee generally agreed that first hand experience of the effects of psychedelics is quite desirable. Absent the ability for the state to require such experience, alternatives were discussed including giving greater weight to voluntary firsthand experience and allowing training programs to include a firsthand experience component in their curriculums.
Dr. Bradley Conner quickly discussed the latest code of ethics, recognizing the need to add provisions for group facilitation and authorized non-healing center locations.
The meeting closed with a brief presentation of Lundy’s latest equity document. Non-voting participant Luke Priel advised that any practitioner, including those practicing in a ceremonial setting, be required to take basic safety training. This suggestion was shut down by the Attorney General reminding the group that the state cannot and will not mandate activity outside of the regulated program.
Next meeting: October 19, 2023 at 1pm MST.
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The full Natural Medicine Advisory Board met for a brief update. Stacie Loucks, the newest member of NMAB, was in attendance. Ms. Loucks has experience as a policy specialist and later, head of regulatory affairs, for the mayor of Denver during the period of retail cannabis legalization. She currently consults on regulatory affairs with a focus on communication between public officials and communities.
The Department of Revenue gave an update on the Department’s Listening Sessions, sharing key takeaways and future plans. The next round of listening sessions, beginning in November, will be longer and offer an in-person option to attend. In addition to building on the information gathered in the previous round, future sessions will cover data collection, inventory tracking, packaging and labeling, business and licensing considerations.
The Board received a brief presentation on the Colorado Nurse-Physician Advisory Task Force for Colorado Healthcare (NPATCH) from DORA staff. NPATCH is a task force of nurses and physicians that provides recommendations on policy changes to enable a better healthcare system. NMAB Chair Lundy will attend an NPATCH meeting to discuss the work of the NMAB and natural medicine.
Each subcommittee shared a brief update on their latest work, none of which was discussed extensively.
At the close of the meeting Chair Lundy requested that all subcommittees prepare recommendations to present in the October meeting. They intend to provide a report on the work of the board, as required by statute, in December.
Next meeting: October 20th, 2023 at 1pm MST.
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Next week, a summary of the Colorado Department of Revenue’s first round of listening sessions.
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- Nothing in this section prohibits an individual from performing a bona fide religious, culturally traditional, or spiritual ceremony, if the individual informs an individual engaging in the ceremony that the individual is not a licensed facilitator, and that the ceremony is not associated with commercial, business, or for-profit activity. C.R.S. § 12-170-108(4).
- A person may not dispense, sell, distribute, or possess with intent to dispense, sell, or distribute, natural medicine or natural medicine product for remuneration. C.R.S. § 18-18-434(5)(c)(II).
- Colorado Department of Health Care Policy & Financing, which administers the state Medicaid program.
- For the complete regulations for Behavioral Health Administration licensure please see 2 C.C.R. 502-1.
- C.R.S. § 12-170-104(12)(c).[/enf_note] The subcommittee learned that ethanol, methanol, water, and acetic acid extractions are permitted in Oregon. They also learned that ultrasonic extraction is a method that can be used in conjunction with any solvent, including water, and is not specifically regulated in Oregon.5Ultrasonic extraction is a mechanical method of extraction using high-frequency sound waves to separate compounds from other materials.
- The “practice of medicine” means holding out one's self to the public as being able to diagnose, treat, prescribe for, palliate, or prevent any human disease, ailment, pain, injury, deformity, or physical or mental condition, whether by the use of drugs, surgery, manipulation, electricity, telemedicine, the interpretation of tests, including primary diagnosis of pathology specimens, images, or photographs, or any physical, mechanical, or other means whatsoever" except as outlined by exception granted to individuals practicing under the Mental Health Act. C.R.S § 12-36-106.
- “Psychotherapy” means the treatment, diagnosis, testing, assessment, or counseling in a professional relationship to assist individuals or groups to alleviate mental disorders, understand unconscious or conscious motivation, resolve emotional, relationship, or attitudinal conflicts, or modify behaviors that interfere with effective emotional, social, or intellectual functioning. Psychotherapy follows a planned procedure of intervention that takes place on a regular basis over a period of time, or in the case of testing, assessment, and brief psychotherapy, psychotherapy can be a single intervention. C.R.S. § 12-43-201.
- Psychologist, social worker, clinical social worker, marriage and family therapist, licensed professional counselor, or addiction counselor.
- C.R.S. § 12-170-105(a)(II)(B) requires training on participant safety, drug interactions, contraindications, mental health and state, physical health and state, social and cultural considerations, preparation, administration, integration, and ethics.
