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Mental Health › Controlled Substances › Food and Drug Administration (FDA)

Foley & Lardner LLP

New Mexico Becomes Third State in the U.S. to Legalize Access to Psilocybin

Foley & Lardner LLP on

On April 7, 2025, New Mexico Governor Michelle Lujan Grisham signed into law SB-219, the Medical Psilocybin Act (the Act), making New Mexico the third state in the country to create a legal pathway for patients to access...more

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

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On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more

Womble Bond Dickinson

FDA Rejects MDMA Treatment for PTSD; Setbacks and New Directions

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In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug Administration (FDA) granted breakthrough therapy designation to MDMA (a.k.a., ecstasy) in 2017 as part of...more

Womble Bond Dickinson

An Update on Medical Research and Legal Battles for Psilocybin

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Scientists continue to research psilocybin as an alternative treatment for multiple neuropsychiatric disorders, including anxiety, depression, and PTSD. We previously highlighted this research in 2021. One area of research is...more

Husch Blackwell LLP

Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

Husch Blackwell LLP on

Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more

Womble Bond Dickinson

Oral Film Medication Delivery of Psychedelics: A Game Changer to Treat Depression?

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Over 300 million people live with depression worldwide. WHO estimates that almost 800,000 people die annually from suicide. Although antidepressants and counseling can be effective treatments for many individuals, there is...more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 29, 2016, Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, “Medicaid and Children’s Health Insurance Programs: Mental Health Parity and...more

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