Medical Spa Industry Is Booming But is Regulation Keeping Up?

medical spa law

medical spa lawMedical Spas nationwide, but specifically in Florida, have been opening up at a staggering pace. For many reasons, including new services, technological advances, and lax regulations, the opportunities for medical spa businesses are endless.

In 2010, there were about 1,600 medspas operating in the United States generating about $1.1 billion in revenue (about $700,000 per medspa on average). By 2018, these numbers increased to over 5,000 medspas generating about $7 billion-$8 billion in revenue (about $1.4 million per medspa on average). The number is expected to grow to over 10,000 medspas by 2023 with about $18 billion-$20.7 billion in revenue.

While medical spa owners have taken advantage of these opportunities, state authorities have yet to keep up. The medical spa industry is largely unregulated, whether that be due to the nature of the services provided, or the explosive growth in this alternative type of medical clinic. On top of that, there’s been a expansion in scope of practice and supervision requirements for certain providers, including nurse practitioners.Continue reading

FDA Warning for Med Spa Owners on “Rejuvenation” Devices

FDA warning

FDA warningBy: Matthew Fischer

At the end of July, the U.S. Food and Drug Administration (FDA) issued a press release to alert health care providers and patients regarding the use of energy-based medical devices that are used to perform vaginal “rejuvenation” procedures.  Although these devices have been approved to treat certain conditions, such as pre-cancerous lesions in the cervix, they have not been approved for cosmetic rejuvenation.  According to the FDA, these procedures have at times been associated with serious adverse events such as burns, scarring, and chronic pain.

Many “rejuvenation” procedures are intended to treat symptoms and/or conditions such as vaginal laxity; pain during sexual intercourse; decreased sexual sensation; and vaginal atrophy, dryness, or itching.  The FDA warning noted that it is aware that multiple device manufacturers may be marketing energy-based devices to treat these symptoms and/or conditions even though to date, the agency has not cleared or approved for marketing any energy-based devices to treat theses symptoms and/or conditions. Continue reading

Med Spa Compliance: Are you Operating Within the Law?

med spa compliance

med spa complianceBy: Jacqueline Bain

On May 19, 2018, Delray Beach medical spa owner Jennifer Aspen was booked into the Palm Beach County Jail and charged with practicing medicine without a license. Ms. Aspen is the manager of Mermaid’s Skin & Wellness, a medical spa located in Delray Beach, Florida. The charges against Ms. Aspen stem from the fact that a Delray Beach police officer presented to Mermaid’s Skin & Wellness for a testosterone shot. Ms. Aspen stated to the officer that she would perform the injection. Ms. Aspen is a certified nursing assistant in the State of Florida. Her license is currently listed as “delinquent” on the Department of Health’s website, meaning that (as of today) she failed to renew her license after its May 30, 2018 expiration date. Certified nursing assistants are not generally allowed to administer testosterone in the State of Florida.

One of the legal issues that presents frequently in our office is med spa compliance; who can open and operate a medical spa if it is just a cash business, meaning that it does not submit claims for reimbursement to any government or commercial payor. Misunderstandings run rampant in the medical spa industry and many times patients are administered treatment from persons who are not supposed to be providing it.Continue reading