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Ketamine

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At the Crossroads of Ketamine and Business

Doctors have relied on ketamine as an anesthetic for half a century, and now they recognize it as a powerful tool for treating mental health conditions. The past decade has seen the rise of ketamine clinics, where health care providers deliver infusions of the drug to treat conditions such as depression and post-traumatic stress disorder.

Harris Sliwoski’s attorneys pioneered the practice of ketamine law and have the experience, knowledge, and judgment to assist physicians and businesses in this quickly evolving area.

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Ketamine and the Business of Health Care

Ketamine infusion clinics deliver health care services and operate in a closely scrutinized and highly regulated industry. Harris Sliwoski helps clinic operators, managers and investors understand and comply with complex federal and state-level rules. These include:

Ketamine infusion clinics deliver health care services and operate in a closely scrutinized and highly regulated industry. Harris Sliwoski helps clinic operators, managers, and investors understand and comply with complex federal and state-level rules. These include:

Bans on Fee-Splitting: Fee-splitting arrangements involve one doctor referring patients to a second doctor and receiving a percentage of the fee charged by the second doctor. To reduce incentives for recommending unnecessary medical care, state laws bar fee-splitting, though fee-splitting can also cause issues under federal law. These rules can apply in complicated ways to benign business arrangements, such as those between ketamine clinics and the management services organizations (MSOs) they pay to handle their administrative needs. An MSO is a service organization of an integrated delivery system/hospital that provides management services for multiple affiliated physicians/clinics. In some states, laws may prohibit MSOs from referring patients to a ketamine clinic associated with that MSO.

The Anti-Kickback Statute: It is a federal crime to give or receive compensation for referrals of patients whose care is reimbursable by federal health care programs. One example of a prohibited kickback is drug businesses paying kickbacks to pharmacies to encourage them to switch patients’ prescriptions. While ketamine infusion therapy is generally not covered by government health care programs, it is still vital that a ketamine clinic not provide anything of value to doctors in exchange for patient referrals. MSOs and other businesses involved in funding or managing ketamine clinics must also comply with these laws.

The Corporate Practice of Medicine (CPOM) Doctrine: To prevent business decisions from influencing patient care, many states have laws barring non-healthcare businesses from providing medical services. For instance, Texas physicians cannot allow their MSOs to select the medical staff with whom the physician works, which directly affects patient care. Relationships between a physician providing ketamine therapy and their MSO must comply with these rules.

 

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Ketamine Laws and Medical Regulations

Ketamine is subject to various laws and regulations that ensure it is handled properly and administered safely. Harris Sliwoski has extensive experience helping businesses navigate ketamine clinic regulations and other requirements:

  • Off-Label Use Liability: Since ketamine infusion therapy is an “off-label” use — one that is medically appropriate but not the specific use receiving Food and Drug Administration (FDA) approval — clinics are exposed to greater malpractice liability. They must hold themselves to exacting standards when handling ketamine and interacting with patients.
  • DEA Classification: The Drug Enforcement Administration (DEA) classifies ketamine as a Schedule III drug, the same category as anabolic steroids and Tylenol with codeine. Federal, state, and local laws address everything from how ketamine must be stored to where clinics may be located.
  • Controlled Substance Requirements: Ketamine’s status as a controlled substance also means that clinics and their staff must understand how DEA registration requirements apply to them.

Lawyers Who Understand the Ketamine Industry

Harris Sliwoski’s ketamine lawyers know the legal and regulatory landscape and understand the needs of health care providers and businesses. We are dedicated to helping our clients address challenges and seize opportunities in this industry.

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Surrounding Ketamine

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PSYCH LAW BLOG

An intelligent, timely resource for the Ketamine industry

Beyond advising individual businesses, our psychedelic attorneys are committed to fortifying, defending, and building credibility for the industry as a whole. Harris Sliwoski’s psychedelic business lawyers are more than legal strategists—they are thought leaders: forward-thinking bloggers, educators, writers, and speakers.

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Get in Touch with Our Ketamine Law Team

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Our Clients' Successes

“Harris Sliwoski expertly guided us through the formation of our company. They continue to assist with necessary registrations and compliance with numerous regulations. They were able to promptly answer all our many questions and provide understandable options, explanations and practical advice. We expect to continue to use Harris Sliwoski on a regular basis as our company expands. They were also able to introduce us other professional experts. We would not hesitate to recommend Harris Sliwoski to any companies in need of legal advice.”

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This law firm was a huge help as our company went through the process of commercial licensing in the California cannabis industry.  They have helped us with a variety of legal issues in a timely fashion, while clearly communicating with us throughout the process.  Everyone we’ve worked with at Harris Sliwoski is an expert in their field and we have always felt that we were in good hands through our legal representation.

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