Ketamine was traditionally only approved by the FDA for the induction and maintenance of anesthesia. Studies have shown that it has great potential for patients suffering from major depression, leading the FDA to approve ketamine, a nasal spray derived from ketamine, for major depression. The DEA has since listed Ketamine as a Schedule III drug meaning it has low abuse potential and accepted medical uses.Recently ketamine clinics that provide ketamine infusion therapy have grown in popularity. Healthcare providers may prescribe ketamine for off-label use if they determine it is medically appropriate for their patient. While most states mirror the federal acceptance of off-label ketamine treatment, some have issued specific guidelines and regulations.
Steps
1. Understand Your Scope of Practice
- Ketamine prescription and administration, whether intravenous, oral, or nasal, constitutes the practice of medicine. Provider licensure, the scope of practice, physician supervision, prescriptive authority, and the establishment of a physician-patient relationship is regulated primarily at the state level.
- Review applicable state, medical, drug, and facility statutes and regulations to identify existing and potential practice barriers.
2. Establish the Business
- Ketamine health platforms provide medical services and must comply with state CPOM prohibitions and related laws relating to professional entities and fee-splitting.
- In many states, operating a ketamine clinic does not require a specific regulatory facility license. Assuming compliance with related laws, a ketamine clinic could primarily operate with the federal DEA licenses and state-controlled substance licenses of its providers.
- Create job descriptions, provide necessary employee training, and establish employment agreements.
- Obtain malpractice and appropriate business insurance.
3. Get in Compliance
- Written policies and standards of conduct
- Compliance officer and compliance committee
- Effective training and education
- Effective lines of communication and hotlines
- Enforcement through disciplinary actions
- Monitoring and auditing
- Prompt response and corrective action.
Don’t let legal hurdles prevent you from offering cutting-edge treatments to your patients. Our experienced healthcare legal team can guide the legal and regulatory requirements for launching a ketamine clinic, including DEA and FDA regulations, state licensing requirements, and compliance with HIPAA and other privacy laws. Book a consultation with our team today, and let us help you launch your ketamine clinic.
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