July 27, 2023

Psychedelic Legal Frontiers: Preparing Practices for MDMA and Beyond with Husch Blackwell

Written by

Alison McInnes, M.D., M.S.

With the FDA designating MDMA-assisted therapy for PTSD as a “breakthrough therapy”, we are on the brink of a seismic shift in our treatment modalities. In fact, 60% of Osmind's surveyed clinicians are specifically interested in providing MDMA for PTSD.

To delve into the evolving legal landscape of MDMA-assisted psychotherapy, we hosted guests, Kimberly Chew and Karen Luong, are co-leaders of the Psychedelic and Emerging Therapies group at Husch Blackwell, a leading healthcare law firm.

Their special unit is devoted to understanding the intricate legalities involved with MDMA therapy and educating practitioners about these regulations.

They decoded the future legal requirements to offer MDMA treatment for PTSD and discussed:

  • Certification Requirements: The first step for practitioners interested in offering MDMA therapy is obtaining the necessary certifications. As MDMA is expected to be approved under the FDA's Risk Evaluation and Mitigation Strategy (REMS), practitioners will need to undergo specific training and certification to offer MDMA-assisted therapy. This program aims to ensure that healthcare providers understand and can mitigate the risks associated with this treatment modality.

  • Liability Concerns: As with any form of therapy, liability is a significant concern. However, it's heightened in this context due to the unique nature of psychedelic substances and their scheduling status. Practitioners need to be well aware of potential liability risks and ensure they're taking all the necessary precautions to avoid malpractice claims.

  • Regulations: State and federal regulations governing MDMA therapy can vary greatly. It's important for practitioners to familiarize themselves with these laws in their specific locations and adhere to them strictly.

  • Risk Reduction Strategies: Compliance with MDMA laws and regulations is not optional - it's mandatory. In addition to being the right thing to do, it's a key step to reduce risk and liability.

  • MDMA Storage: There are specific rules surrounding the storage of MDMA that practitioners must abide by. Non-compliance with these rules can lead to legal consequences.

Kimberly and Karen also offered insights into the potential of insurance coverage for MDMA therapy, drawing from their experience with ketamine clinics and the regulations that surround them.

This enlightening conversation painted a clear picture of the legal landscape surrounding MDMA-assisted therapy and made it apparent that integrating MDMA into therapeutic practice involves more than just the treatment itself. It requires a comprehensive understanding of the legal landscape and strict compliance with all applicable laws and regulations.

Listen to the full episode of "Psychiatry Tomorrow" with the embedded podcast player at the top of this post, or on your favorite podcast player!

Shownotes and Timestamps:

  • 3:00: MDMA for PTSD certification requirements for practitioners
  • 5:20: REMS program explanation and how they’re collecting post-marketing data.
  • 6:30: Liability concerns practitioners should be aware of with MDMA and current lawsuit types they’re currently seeing, and how to avoid them.
  • 8:45: Any litigation concerns we can learn from ketamine as an example (different types of insurance practioners should get to avoid a lawsuit or claim)
  • 11:40: Other training considerations to avoid legal issues to be prepared
  • 12:30: state and federal regulations that govern MDMA therapy (false start) - start over at 11:45
  • 15:30:How state and federal laws intersect, and the significance of trigger laws
  • 16:25: How friendly is California to these MDMA developments?
  • 16:55: How can practioners make sure they’re within compliance with MDMA laws?
  • 18:11: Will the public have an opportunity to chime in with commentary and support for MDMA’s legal status/rescheduling? How to use the public comment system to advocate.
  • 19:20: Once rescheduled, what are the rules for purchasing and storing MDMA?
  • 21:10: Security concerns
  • 21:40: Legal considerations for MDMA therapy compared to other substances - how intense will the regulations be?
  • 23:40: Will there be standard operating procedures (SOPs) for uniform standards for psychedelics?
  • 25:05: Insurance coverage for psychedelics and CPT codes
  • 27:00: Why approving psychedelics for insurance reimbursment saves insurance companies money? The case for covering psychedelics.
  • 28:18: What’s the best way to reduce risk and reduce malpractice claims heading into this decade? Details about transporting patients.

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