By Brad Adatto, JD, Partner, ByrdAdatto
Whether you’re an entrepreneur or a veteran business owner of a med spa, you know that business tends to run hot and cold. But does it really matter that business is hot when lifestyle preferences are cooling down? Literally. CoolSculpting is the growing phenomenon that is shifting a culture that was once obsessed with burning fat to freezing it.
CoolSculpting offers a fat reduction alternative to liposuction and a lifestyle alternative to diet and exercise by freezing and eliminating targeted fat cells using a process called cryolipolysis. The process is noninvasive, nonsurgical, and FDA approved. But make no mistake, there are still plenty of legal considerations to navigate before entering into one of the fastest growing practices in the country.
While the procedure is commonly referred to as a “cosmetic” treatment, CoolSculpting, or cryolipolysis, is considered the practice of medicine and a medical treatment in many states. Therefore, businesses must be extremely careful when navigating state laws regulating the practice of medicine, including the ownership and staffing of a CoolSculpting business.
Here’s what you need to know:
Ownership. 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 CoolSculpting business and the type of liability that may be associated with the structure you choose.
You also need to know if there are any licensing restrictions on owning a business that renders medical services in the state(s). California, for example, limits the ownership of businesses that provide medical treatments to California-licensed physicians, but also allows partial ownership by a list of other non-physician health care providers, subject to strict and narrow business and ownership structure requirements.
The Practice of Medicine. What constitutes the practice of medicine or medical treatment varies from state to state, and these laws can be specific and nuanced to varying degrees. Therefore, you need to know whether CoolSculpting is considered the practice of medicine, and consequently a medical treatment, in your state. For example, Texas considers diagnosing a person as an appropriate candidate for a cosmetic medical procedure and giving orders for their treatment to be the practice of medicine.
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 the treatment in your facility. It critical that state laws governing who can legally perform medical treatments, such as cryolipolysis, are not confused since many states only permit state-licensed physicians, physician assistants, nurse practitioners, and certain other licensed healthcare professionals to perform cryolipolysis, subject to state laws governing delegation and supervision.
Brad Adatto, JD, is a partner at ByrdAdatto, a business, healthcare, and aesthetic law firm that practices across the country. He has worked with physicians, physician groups, and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions, and contract terms, including Medicare fraud and abuse, anti-trust, anti-kickback, anti-referral, and private securities laws.