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Off-Label Botox Treatments to Expand Your Med Spa Menu

Posted By Administration, Wednesday, March 1, 2017
Updated: Tuesday, July 31, 2018
Although we all know Botox is primarily used for smoothing wrinkles, today, more and more physicians are expanding their menus by providing off-label uses for Botox that actually have nothing to do with age prevention. According to Time magazine, "More than half of Botox's revenue comes from its therapeutic uses for conditions as varied as chronic migraines and back pain to excessive sweating and twitching eyelids." If done right, offering these treatments could be a real differentiator for your medical spa. Following are just a few treatments that you can add to expand your menu:

1. Chronic Migraines
In 1992, a Beverly Hills plastic surgeon named Dr. William Binder observed a correlation between the use of Botox and the alleviation of pain in patients with headache symptoms. Although this study reported patients having few headaches, some doctors still question if the drug is truly effective or simply has a placebo effect. Nonetheless, if you take a look at the RealSelf approval rating, nearly 90% of patients are happy with the results.

2. Excessive Underarm Sweating
Botox was approved in 2004 to treat the condition called severe primary axillary hyperhidrosis. According to the International Hyperhidrosis Society, "Research demonstrates that treating excessive sweating of the armpits, hands, feet, head and face (craniofacial), and other relatively small body areas (like under the breasts) with onabotulinumtoxinA is safe and effective." It has been shown to result in an 82-87% decrease in sweating, and 86% of Real Self users say that it is worth it.

3. Painful Sex
You can use Botox to treat muscle spasms in the pelvic floor for patients that suffer painful intercourse. The Botox injections help ease pain by making the muscles stop contracting. According to doctors at the Cleveland Clinic, "Some people need injections every six to nine months. Others may only need them every 12 to 24 months." This could be something promoted as a series treatment, to keep clients coming back to your medical spa.

4. Severely Cold Hands
Doctors at the Cold Hand Clinic at the University of Chicago have used Botox to treat patients with very cold hands. Botox is injected into the hand to relax muscles surrounding constricted blood vessels. As the vessels relax and enlarge, more blood can flow through to supply the rest of the hand and the fingertips. The patient could have symptom relief for up to three months.

Now before you add any of these treatments, make sure you understand how the law governs these procedures.

"Generally speaking, physicians are free to use treatments 'off label' so long as they are trained in the off-label use and the treatment is, in the physician’s professional opinion, safe and appropriate. The law allows for off-label use and it is up to the patient, in consultation with his or her physician, to consent to such use. Off-label use of prescription drugs and treatments often provide great effect, but it is important for the physician to inform the patient of--and for the patient to understand--any risks and side effects from such use."

- AmSpa Founder and Director, Alex Thiersch

For more information on medical spa laws and regulations AmSpa members can check their state's Medical Aesthetic Legal Summary or utilize their annual complimentary compliance consultation with the business, healthcare, and aesthetic law firm of ByrdAdatto.

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Shady at Best, Dangerous to Patients at Worst | Parallel Importation

Posted By Administration, Friday, January 20, 2017
Updated: Wednesday, May 23, 2018
As you no doubt are well aware, botulinum toxin treatments—primarily Botox, but also including competitors such as Dysport and Xeomin—are among the most popular procedures in the medical aesthetic industry. According to the American Society for Aesthetic Plastic Surgery (ASAPS), more than 4.25 million of these treatments were administered in the United States in 2015, for a total expenditure of more than $1.35 billion—the most of any cosmetic procedure, surgical or otherwise. At an average of $317 per treatment, botulinum toxin is affordable for patients, yet still quite profitable for practices. But some want more, and they are beginning to put themselves in danger in the pursuit of larger profits.


One of the ways in which practices are attempting to do this is by buying cheap, usually counterfeit botulinum toxin from other countries, most prominently China. These drugs are not particularly difficult to procure on the Internet if you know where to look and, to some medical aesthetic practices, this represents a way to avoid paying the name-brand premium that legitimate botulinum toxin carries, such as Botox.
While this is shady at best, and dangerous to patients at worst, historically it tended to be fairly easy to get away with. Recently, however, the U.S. Food and Drug Administration (FDA) has stepped up the enforcement of its statutes (fake botulinum toxin is not FDA approved, of course), seizing these drugs at the border and handing down criminal charges against those in the United States who are complicit in their importation, such as the practices that order it.


This enforcement effort has proven to be extremely controversial. “It’s caused quite a bit of angst,” said Michael Byrd, partner for ByrdAdatto, a national business and healthcare law firm based in Dallas. “There’s a lot of unhappiness, even within the governmental agency [FDA]—they refer to themselves in a derogatory manner as the ‘Botox police’ or the ‘Allergan police.’”
FDA agents may feel like their strings are being pulled by a corporation, but this is also unquestionably a matter of maintaining the health of the botulinum toxin-using public.


“Those who are against it say that it’s really just action on behalf of Allergan for Allergan to keep their prices [high]. Those who are for it, as you might suspect, point to patient welfare.”
-Michael Byrd, partner for ByrdAdatto 


Regardless, enforcement has increased, and the charges you can incur as a result of being caught with counterfeit botulinum toxin are very serious. If your owner or operator is found guilty of them, they could theoretically serve jail time in addition to facing heavy fines and the suspension of their medical licenses.


Medical aesthetic practices have also attempted to purchase less expensive botulinum toxin treatments by engaging in a practice called “parallel importation,” whereby a licensed foreign entity purchases legitimate US-produced drugs at a lower rate than US-based distributors (due to local price controls) and then resell them to US-based practices for far less than it would typically cost for the practices to procure them from domestic sources. The US Supreme Court broadly upheld the legality of this practice in the case of Kirtsaeng vs. John Wiley & Sons, Inc. (2013), although that particular case related to textbooks, not prescription drugs. As such, there are still some grey areas involving FDA compliance that make this practice risky, despite the fact that every step of the process seems to respect the laws of both the country in which the outlet is located and the United States.


“Enforcement typically stems from an employee, patient, or American industry representative reporting a foreign label on the product. Because the labeling is different on legitimate US products purchased by a foreign entity, practices engaging in parallel importation are also being reported,” explains Byrd. “When I counsel my medical spa or cosmetic practice clients, [I tell them] you have to recognize the risk that comes with any effort to utilize parallel importation. Even if a client is ultimately not found guilty of wrongdoing, an enormous business cost comes with losing inventory in a raid, legal costs to defend the action, and the business disruption that comes with an enforcement action. There is, of course, also risk regarding the legality of the use of parallel importation for prescription drugs. And so, my counsel would be that if you do anything other than buy an FDA-approved and US-distributed product, you have to recognize both of these risks.”


For now, it is probably best not to engage in parallel importation, but it is entirely possible that in the near future, it will be a viable way to purchase FDA-approved products.


 
AmSpa provides a variety of legal and regulatory resources for medical aesthetic practices and medical spas to help you stay legal and compliant. Learn more about our member benefits here


This article originally appeared in the December issue of Modern Aesthetics.

Tags:  Business and Financials  Med Spa Law  Med Spa Ownership 

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