Medical spas are regulated by a patchwork of state rules and regulations usually governed by a medical board. In addition to standards and protocols regarding delegation/supervision of non-physicians such as physician-assistants, nurse practitioners and registered nurses, there are corporate practice of medicine restrictions and acceptable ownership legal entity types which vary by state. Some states require specialized training, licensure and continuing education, while others have rules regarding profit-sharing and sales tax on procedures. In-office and website disclosure requirements, along with restrictions on marketing activities, further contribute to the regulatory framework.
Recent events in Texas where a patient died from sudden cardiac arrest following intravenous (IV) hydration prompting the Texas Medical Board to suspend the Medical Director’s license, have brought the medical spa industry into the public eye resulting in increased enforcement scrutiny. Novo Nordisk has filed lawsuits against medical spas alleging false advertising, trademark infringement and unlawful sales of compounded semaglutide, highlighting the industry’s vulnerability to legal challenges. Concerns arise particularly in practices characterized by absentee physicians, those without adequate protocols or patient screening procedures, or where untrained medical assistants are performing procedure prompting calls for legislative action.
Furthermore, the medical board pendulum is swinging toward greater oversight (e.g. Arizona, South Carolina and North Carolina) for medical spas especially with regard to newer procedures increasing in popularity such as IV hydration and therapy, medical weight loss injections (e.g. compounded semaglutide) and platelet-rich plasma injections. Despites procedures often being patient-directed or requested, medical professionals remain liable, with Boards looking into processes in place, medical director agreements, written protocols, on-site supervision or distance of the medical director, availability, and contingency plans (e.g. AED device). If a complaint is filed, it is important to keep in mind that the totality of the circumstances will form the basis of how the Medical Board will view it. Many compliance issues exist for spas and failure to address them places physician medical licenses at risk.
How Frier Levitt Can Help
Setting up ownership of a medical spa with the proper format and implementing appropriate policies and procedures (P&P) and supervision is vital. Complaints may prompt regulatory, civil liability and even criminal prosecution and can originate from dissatisfied patients, disgruntled employees or your competition. Frier Levitt offers essential support in establishing the ownership structure of a medical spa, ensuring adherence to proper formats, and implementing relevant (P&P) and supervision protocols. Whether responding to complaints or proactively seeking a compliance review and overhaul, Frier Levitt’s legal team can provide invaluable assistance. Contact us today to consult with an attorney and navigate the complex regulatory landscape of the medical spa industry.
