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Ketamine
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 including depression and post-traumatic stress disorder.
Harris Bricken’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.
Contact UsKetamine and the Business of Health Care
Ketamine infusion clinics deliver health care services and operate in a closely scrutinized and highly regulated industry. Harris Bricken 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, like the ones between ketamine clinics and the management services organizations (MSOs) they pay to handle their administrative needs. An MSO is 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 for business 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 mind 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 who the physician works, which directly affects patient care. Relationships between a physician providing ketamine therapy and their MSO must comply with these rules.
Ketamine Laws and Medical Regulations
Ketamine is subject to various laws and regulations that ensure it is handled properly and administered safely. Harris Bricken has extensive experience helping businesses navigate ketamine clinic regulations and other requirements:
- 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.
- 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.
- 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 Bricken’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.
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 Bricken’s psychedelic business lawyers are more than legal strategists—they are thought leaders: forward-thinking bloggers, educators, writers, and speakers.
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Joseph Axelrod, General Counsel Irwin Naturals
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