Colorado Releases Draft Rules for Psychedelic Therapy

rules

Colorado regulators have just released preliminary rules for the psychedelic therapy industry. 

In late February, the Department of Regulatory Agencies (DORA) released a draft of these rules regarding facilitator education, training and licensure, as stated in the Denver Post. Over the next year, the rules are expected to change with discussion and public input. 

These draft rules come after the Natural Medicine Health Act was passed in 2022, which legalizes access to certain plants or fungi for people 21 years of age and older within a venue created for supervised participation by state-licensed facilitators. The Act also decriminalizes personal use of certain plans and fungi for individuals over the age of 21, according to the website.

The Beginning Processes

The program that will offer supervised natural medicine participation is expected to launch January 1, 2025, which means the finalized rules need to be ready by the end of this year. The two organizations involved with putting this program and the Act together are DORA and the Department of Revenue (DOR). 

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DORA will be responsible for:

  • Licensing and regulating Facilitators (persons licensed to provide natural medicine and related services)
  • Managing the Natural Medicine Advisory Board
  • Managing the Federally Recognized Tribes & Indigenous Community Work Group
  • Having Annual Reporting responsibilities (in coordination with DOR)

And DOR will be responsible for:

  • Licensing and regulating  healing centers, cultivations, manufacturers and testing facilities under a new Natural Medicine Division
  • Managing a testing and certification program (in coordination with CDPHE)
  • Collecting data 
  • Managing public education campaigns
  • Producing training materials for first and multi-responders
  • Having Annual Reporting responsibilities (in coordination with DORA)

“On March 8th, DORA had a stakeholder hearing with their regulations, and DOR has a series of stakeholder meetings over the next three to four months about different topics,” said Joshua Kappel, Founding Partner, Vicente LLP, in a webinar. “The goal is to have all regulations finalized by late summer of this year, or even early spring, so the program can go live next year.”

The Proposed Rules

In a webinar hosted by reMind, both Kappel and Tasia Poinsatte, Colorado Director, Healing Advocacy Fund, discussed the new proposed rules, how they impact people in Colorado and what it means for the industry. 

The four proposed licenses would be for students, a regular facilitator, a clinical facilitator and a trainer. Each type of license would require different types of training, they stated. 

For a regular facilitator, the proposed rules include dozens of hours of coursework at a training facility that would certify someone in areas like mental health, safety, trauma-informed care, Indigenous considerations and even self-care. 

Licensees would all have to be over the age of 21 and be certified in basic life support. 

The proposed rules also list out what type of patients facilitators should not serve, including people with a history of schizophrenia and bipolar disorder. Some of the prohibited conditions could be exempted with the approval of a medical professional, they stated. 

Questions Left Unanswered

While this is a huge step forward for Colorado to allow natural medicines to be integrated into an existing medical system, Kappel also noted that some of the details are causing concern. 

“One of the questions you’re left with is if you’re someone who’s been diagnosed with PTSD, should you be forced to see a clinical facilitator versus a non-clinical facilitator,” he stated. “There are some issues around the stratification of people forced to see certain providers, and this may or may not create problems.”

Another issue that needs to be addressed under the DORA draft rules is the lack of pre-approval for training programs, according to Kappel. In order for everything to be ready by January 1, they should start offering classes sooner so all facilitators can be trained on time. 

“Also under the DORA rules, will Telehealth be able to be integrated for sessions? What locations will be allowed for the centers? What are the standards of care? How long does someone have to be at a service center after taking a dose? All of these haven’t been put to paper yet,” noted Kappel. 

The Finalization of the Draft Rules

Poinsatte said that there are a lot of opportunities for people to get involved and help both DORA and DOR finalize the rules for the program. “DOR has a number of meetings taking place over the next few months, which are all posted on the Natural Medicine Division website. They will also be releasing pieces of the draft rules prior to each meeting so people have the chance to review those and comment during the meeting,” she said. 

Anyone can register in advance for the meetings and attend them virtually. You don’t need to speak if you’re just planning on listening in, but you can submit comments if you have certain questions or comments for the draft rules. 

“They’re really looking for feedback on this process,” Poinsatte stated.