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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