123’s of Anti-Aging Treatments
“Alternative medicine,” “wellness treatments,” or “anti-aging procedures” all have one element in common: each has treatments and procedures that fall within the practice of medicine. Most state’s statutory definition of “practice of medicine” includes any diagnosis, treatment, or offer to treat a physical disease, disorder, deformity, or injury by any system or method. Further, anytime the outermost layer of the epidermis is penetrated, whether by injection, abrasion, or incision, the procedure is considered a medical treatment.
As such, treatments or therapy that include hormone replacement, stem cell, and ozone administration are considered the practice of medicine. This limits who can actually perform these producers and where these produces can be performed. Over the years we have had many individuals that choose to either ignore this advice, or push back on this explanation, asking “How is everyone else doing it?” As more individuals open “alternative medicine facilities,” “wellness clinics,” or “anti-aging centers,” we have seen an increase in enforcement from state agencies, medical boards and law enforcement. Therefore, businesses must be extremely careful when navigating state laws regulating the practice of medicine, including anti-aging therapies. Here’s what you need to know.
The Practice of Medicine. Every state’s statutory definition of practice of medicine includes diagnosis and treatment of a medical condition. Specifically, Texas’s definition of practice of medicine includes diagnosing or treating any physical disease or disorder. Florida’s definition includes diagnosis, treatment, operation, or prescription for any human disease, pain, deformity, or other physical or mental condition. As an example, diagnosing a person as an appropriate candidate for hormone therapy and giving orders for such treatment is the practice of medicine. Furthermore, facilities that offer ozone therapy as a medical treatment, may be outside the scope of what is consistent with the standard of care for that state. At this time, the FDA has not approved of ozone therapy as a drug or device. Additionally, ozone therapy is not recognized nor approved as part of the practice of allopathic medicine by federal law or any state medical board. As such, providers offering this as a treatment must check with their state medical boards to confirm restrictions apply on “who” can provide complementary and alternative medicine.
Ownership. Essentially, the corporate practice of medicine doctrine prohibits non-physician-owned business entities from engaging in the practice of medicine. States adopting the doctrine, are attempting to ensure a medical provider is responsible for the control and direction of a medical facility. You should develop your business and ownership model according to the laws of the state(s) in which you plan to practice. Because these laws vary from state to state, you need to know how to legally structure your business and the type of liability that may be associated with the structure you choose. For example, in New York, the State limits the ownership of businesses that provide medical treatments to licensed physicians. Other non-physician health care providers are prohibited from ownership of the medical facility.
Staffing. Medical professional scopes of practice not only vary from state to state, but also vary depending on the training, experience, and skill of a medical professional. Therefore, you need to know who can legally perform anti-aging treatments in your facility. For example, let’s assume you meet the state requirements to provide stem cell therapy, and you recommend to a patient the injection of mesenchymal stem cells into the patient’s skin to improve skin tone. This is the practice of medicine. Who has the authority to recommend the treatment (physician, NP or PA)? Who can actually inject the patient (RN or MA)? It is critical to understand the diagnoses, delegation, and supervision regulations before performing these procedures.
Before opening your anti-aging business, you should carefully navigate your applicable state laws and limitations. Failure to do so may accelerate the demise of your business. For more information on a developing a compliant business, please contact Bradford E. Adatto at Badatto@byrdadatto.com or (214) 291-3201.