Injectables for off-label use:
One of the many questions we receive as Aesthetic Professional Liability Insurance (APLI) brokers is :
Am I covered for this off label use of this service?
A follow up to this question: ..okay, so I’m covered for Botox and Restylane….
Do I have to clear all aesthetic services with my Medical Malpractice Insurance carrier ..there are so many ‘off-label’ uses in this industry?
The insurance application:
The application becomes part of the legal insurance contract; these carriers design the application specific to their intended product niche.The doctors insurance agency works with half a dozen aesthetic professional liability insurance carriers – domestic and international. They design general applications, which can apply to wellness, integrative clinics, MedSpas, IV Hydration Lounges/clinics and other iterations of this growing field.
The medical spa supplement to the application lists many (most) services that are approved and considered ‘customary’ to the business of Aesthetic Medicine.They have been underwritten and approved. An important rule of thumb: if the service and material have been included in the application, the underwriters have considered and rated the quote accordingly; it is included in the coverage!
Usual and Customary:
Generally if the service like botox or juvederm is considered usual and customary in the medical spa industry, and you are working within your credential, ( consistent with your education training and experience),
Then you are covered. All of these Medical Spa Insurance carriers understand that Botox and Juvederm are used for ‘off-label’ purposes.
I learn from so many online journals that support the Aesthetic Industry: - like the attached article from Fashionista. (attached here)
As the article below points out, a lot of these medical services were developed by physicians with raw materials in hand, going rogue:
Imagine the first person who ever injected Botox," muses Dr. Anna Guanche, a board-certified dermatologist and celebrity beauty expert based in Calabasas, Calif.
"It's a toxin, it's a poison. It was 1971 and somebody injected freakin' poison into someone and we slowly, slowly got used to the idea that it's a purified toxin, and it's not going to give you botulism."
‘On-label use is otherwise known as "approved treatment area" use. "An 'approved treatment area' means that a product has been evaluated and approved by the FDA to help a specific indication for that area," a representative for Allergan, the maker of Botox Cosmetic and Juvéderm, tells Fashionista.
"In order for a treatment to receive FDA approval, it needs to prove its efficacy by meeting certain criteria defined within clinical trials."
Clinical trials can take years and cost millions of dollars — even billions, according to Dr. Guanche — so it's no surprise that there are fewer approved treatment areas than there are off-label options.
Botox Cosmetic and other neurotoxins are FDA-approved for the crow's feet, frown lines and forehead lines. Dermal fillers, including Juvéderm in its many forms — Ultra XC, Volbella XC, Voluma XC, et al. — have been cleared for use on the lips, nasolabial folds, cheeks and "moderate to severe facial wrinkles and folds," according to Allergan. Kybella, an injectable that destroys fat cells, is only approved for use under the chin.
Aesthetic Professional Liability Insurance underwriters are supportive of the associations like AMSPA, AAD, ASPS and others that are active in this effort to understand and support safe aesthetic and age management businesses.
Manufacturers, Dermatologists, Plastic Surgeons and vendors in the aesthetic trade work together to develop this concept of ‘approved use’.
The insurance carriers contract with many aesthetic professionals in the group above to develop standards of underwriting and insurance for services and procedures offered in medspas.
Approved and accepted use is a sort of case law of medical professional practice..
There are analogies in medicine where an unintended use of a device, material or drug has been put to effective application through the art of medicine and Medical innovation. I like the references to antihistamines, antibiotics, anti-inflammatories all were originally intended and studied for different medical indications.
And specifically in the medical aesthetic space the use of Kybella below the chin. These drug and medical service interventions evolve outside of expensive and lengthy clinical trials. As the medSpa field continues to grow and results confirm commitment, we expect more services and procedures to be introduced and approved (normalized).
With this approval and main-stream use, aesthetic professionals develop ‘best practices’ protocol with more attention to risk management.
The Doctors Insurance Agency remains committed to understanding and working with you to obtain complete aesthetic liability insurance policies.
Our carriers are involved in this niche daily. They are reputable, affordable and flexible responding to successes (and failures) in Aesthetic Medicine to develop sustainable premiums.
If you ever have a question or concern about the procedure or service you are beginning first send an email to your broker so the approval is documented, and possibly priced into your policy.
We specialize in helping you find scalable, affordable and complete liability protection.