A new evolution in Medicine has emerged- the Medical Spa. Medical Spas have become a booming and profitable industry providing Botox, Collagen, and Restylane. These spas are now heavily regulated by licensing agencies. This new industry is re-defining traditional medical treatment, and in doing such has created confusion for many medical professionals- with many thinking that such services are “just” cosmetic, similar to a facial or pedicure. However, contrary to the assumption of some, these injectable procedures involve prescriptive medical devices and “dangerous drugs,” (as defined by Business and Professions Code 4022), and as such are considered a medical procedure that requires a trained and licensed healthcare provider to evaluate patient suitability via a “good faith examination,” and proper administration of the medication. Additionally, the management of a medical spa requires the same supervision and administering of medical care as a medical office.
The Department of Consumer Affairs, The Medical Board of California, the Board of Registered Nursing, The Food and Drug Administration (FDA), the United States Attorney’s Office, and District Attorney’s Office are cracking down on medical doctors, physician assistants, nurse practitioners, registered nurses, and unlicensed individuals who are not adhering to the laws and regulations. These regulatory bodies are prosecuting healthcare professionals for such violations as the unlicensed practice of medicine (Business and Professions Code 2052), corporate practice prohibitions (Business and Professions code 2400), fee-splitting and payment for referrals (Business and Professions Code 650), and the aiding and abetting in the unlicensed practice of medicine (Business and Professions Code 2264). As such regulatory agencies are bringing both criminal charges in addition to license discipline. The MBC and BRN have articles on point.
Additionally, there have been reports of practitioners either unwittingly, or unknowingly in the effort to reduce overhead cost, injecting toxic counterfeit drugs from overseas that have made patients critically ill, caused disfigurement and even death. The only legal and permitted drugs must be purchased in the United States not in oversees market- to ensure their legitimacy. Federal regulators are warning as well as prosecuting Health Care professionals for purchasing product for reduced costs in Canadian and European markets to circumvent the cost of FDA compliance (21 U.S. Code § 331).
The use of prescriptive medical devices and injections for cosmetic reasons is the practice of medicine. The laws that govern the practice of medicine are the same laws that govern these “med spa” procedures. Physicians (and other healthcare professionals) will be held accountable for the same standard of care as they are for their routine medical practice. This means that the standards of informed consent, good-faith exam, delegation to an allied health care professional, patient –physician confidentiality, maintaining medical records as well as responsibility and liability of supervision.
At the Law Office of Nicole Irmer we have represented Healthcare Professionals including Doctors, Physician’s Assistants, and Registered Nurses facing criminal and/or disciplinary charges in this emerging area of prosecution. This article is brief as to the potential liability a healthcare provider may be facing in an illegal medical spa arrangement. If you have been contacted by an investigator please contact our office to discuss the matter further.