There is a great article in the “throw-away” MedEsthetics magazine (July/August 2011 issue) written by Padriac B. Deighan, MBA, JD, PhD. You can read the entire article here (pp 16-20; online issue). If you employ any practice extenders in your office or run a medical day spa, you will find the article useful.
Deighan categorizes injectables in three ways: botulinum toxins, dermal fillers, and sclerotherapy.
Botulinum toxins are prescription only drugs which are available to physician offices and via pharmacies, but not directly to non-physicians. In other words, a registered nurse can inject neurotoxins under physician supervision, but cannot acquire them.
Botulinum toxin injection is considered a medical procedure which should only be provided in a medical setting by a trained and licensed provider (ie physician, registered nurse, nurse practitioner or physician assistant).
Deighan notes that a medical spa is a medical setting ONLY if it is owned by a physician. He recommends against Botox parties in patient’s homes, even though a physician can legally provide this service in that setting.
Injectable dermal fillers are not prescription drugs, but are medical devices
As such, they are delivered pursuant to the practice of medicine and all state and federal guidelines. This is a distinction without difference because, although they are not prescriptive, medical devices – as categorized by the United States Food and Drug Administration (FDA) – can only be utilized in a medical facility and delivered to patients by an appropriate medical provider.
Non-medical day spas or even medical day spas without physician supervision should not be injecting dermal fillers.
Moving on to sclerotherapy used most commonly to treat leg veins but also other areas. Sclerotherapy is the introduction of a foreign substance into the lumen of the vein to cause thrombosis and subsequent fibrosis. The injected solution falls into three types: Chemical Irritants (glycerin, polyiodinated Iodine), Hypertonic solutions (Hypertonic-saline 11.7%, Hypertonic-glucose), and Detergent sclerosants (Sodium morrhuate, Sodium tetradecyl sulfate, 0.25% -3%, Ethanolamine oleate, and Polidocanol foam, 0.5-5% ).
Deighan states that saline is not considered a medical device or product, but the others are and therefore are subject to medical practice guidelines for the particular state and must be delivered in a medical setting.
Please go read the article for his take on CMAs (certified medical assistants) and cosmetic medical procedures. Here’s part of it:
Recently, many CMAs have wrongfully asserted that they are allowed to inject and, therefore, have been injecting botulinum toxins, dermal fillers and sclerosants. CMAs are marginally trained, non-medical personnel………
It will also be a huge problem in any professional negligence claim, because there will be no coverage for such a loss. An insurance carrier will not provide a defense or indemnity for any claim related to these procedures. …….
He extends this same stand to “certified” technicians.
For example, some “certified laser technicians” and their employers incorrectly believe that the designation “certified” elevated their stature and allows them to perform medical services. Certified Laser Technician, Certified Medical Esthetician, and Medical Esthetician are not categories of medical providers. ……..
Medical Spa Regulations (March 26, 2009)
Medical Lasers and the Law (March 25, 2009)