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Are Botox Parties Legal? Are They Worth It?

Posted By Administration, 1 hour ago

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

Botox parties are a common topic in med spa law because of how lucrative they can be, but are they legal?

One thing I love about the med spa industry is that med spa owners and providers are continuing to innovate. The ideas that come from AmSpa members on marketing, branding, and business always leave me impressed. This is one reason why it is so difficult to keep track of what’s legal and what’s not - many of the ideas we are asked about are brand new. They’ve never been tested before, and therefore it’s difficult, if not impossible, to determine where the legal constraints are.

While not new, Botox parties are an innovation like this. These are events hosted by a med spa or a provider, either at the med spa or another location, where people get together to socialize, learn about treatments, and try new treatments. Often the med spa provides discounts on product so that they can get new patients in the door. Often alcohol is served. These are highly social events that mix pleasure with aesthetics, which makes the idea of getting injected with a needle a little more palatable.

A question I get all the time, though, is whether these events are legal, particularly when they are held outside of the med spa (at someone’s house or a salon). And the question that always follows - is it worth it?

The answer to both of these questions is yes - it is absolutely legal (in most states - sorry, Nevada*), and it is ABSOLUTELY worth it. But like most things in this industry, both of these answers are dependent upon you adhering strictly to the law. No amount of money is worth losing your license, and, yes, I have seen nurses lose their licenses because of improperly hosted Botox parties. AmSpa members can check their medical aesthetic legal summary to find the law regarding Botox parties in their particular state.

The primary point to remember is that when you provide any medical treatment off site all the same rules apply. New patients must be seen by a doctor, nurse practitioner (NP), or physician assistant (PA) prior to being treated. Proper records must be kept. Consents must be signed. Before and After photos should be taken. Everything that you are required to do legally in your med spa should be done at the Botox party.

Additionally, check with your insurance carrier before the party to ensure that you have coverage for offsite treatments, and double check local ordinances regarding serving alcohol - sometimes a permit is required.

Initial Exam

The biggest risk at Botox parties, or any social event involving med spa treatments, is that a patient will be treated by an RN without first seeing the doctor (or NP/PA). All patients must be seen first so that a plan can be set. This can ONLY be done by an MD, or by an NP or PA operating under proper authority. Indeed, even if the patient consents to being treated by the RN without first seeing the doctor, that does not allow the RN to inject the patient without the patient first seeing a doctor.

At Botox parties this can be difficult because there are new patients socializing, there is sometimes alcohol being consumed, and everyone is more relaxed. This is a step that MUST be followed, though, because an RN cannot practice medicine, and therefore the RN cannot legally perform the initial assessment, establish the physician-patient relationship, and set a treatment plan. There are no exceptions to this rule.

Patient Consent

Equally as important is obtaining patient consents, including privacy waivers given that treatments are usually performed out in the open. And providers should be mindful of patients consuming alcohol. While not strictly illegal, we all know that alcohol makes people less inhibited and often clouds judgment. This is NOT good when it comes to patient consent. All patients should offer consent before they begin drinking, and the drinking should be kept to a minimum. This is not always easy, but trust me, if there’s an adverse outcome you’ll wish that alcohol was not involved.

Patient Privacy

Also be mindful of photos and social media. These events are a great way to market your med spa - people are having fun, everyone is happy, and you remove much of the clinical aspects of aesthetic medicine. Be careful, however, when photos or videos are posted - every patient is entitled to privacy, and if any patient has failed to sign a privacy release and an authorization to use their photos, there is a risk of a breach of patient privacy.

Are They Worth It?

So the fact that these events are legal begs the question - is it worth it? The answer is emphatically yes, provided you strictly adhere to legal guidelines. Botox parties and social events are a great way to get new clients introduced to your practice, pre-book treatments, and bring in some cash.

The usual protocol is to offer discounts on treatments and pre-bookings (both for injectables and laser packages), provided they are purchased that night. Patients are encouraged to bring friends and colleagues to meet the providers and learn more about aesthetics. Depending on the size of the event, it is not uncommon for a practice to bring in six figures worth of treatments and bookings - in one day.

Even that kind of money isn’t worth losing your license, though, so be careful and diligent with your compliance efforts.

I urge you to move cautiously when it comes to planning and hosting one of these events. Do your homework and ensure compliance is in place. Go easy on the alcohol. Make sure you’ve got proper insurance. If you have any questions whatsoever, consult with a qualified lawyer ahead of time so that all of the proper documentation is in place, the needed personnel are available, and all the rules are followed.

For more information on running your med spa legally and profitably, attend one of AmSpa’s Medical Spa & Aesthetic Boot Camps, and become the next med spa success story.

*Nevada recently passed a law restricting the injection of Botox and fillers to a doctor’s office, essentially banning the ability to host Botox parties.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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AmSpa and ByrdAdatto Joint Statement on FDA Vaginal Rejuvenation Warning

Posted By Administration, Monday, August 13, 2018

The American Med Spa Association
224 N Desplaines St, Suite 600
Chicago, IL 60661


ByrdAdatto
8150 N Central Expy #930
Dallas, TX 75206


The US Food and Drug Administration recently issued a warning to several device manufacturers regarding the marketing associated with “vaginal rejuvenation,” and the American Med Spa Association and the law firm of ByrdAdatto want med spa practices to understand how this relates to their day-to-day operations.

Med spas and other health care professionals should not panic as the FDA will not be raiding their businesses. The FDA does not have any control over a physician’s ability to prescribe “off-label” which in this case would be when physicians are using the energy-based devices to perform vaginal rejuvenation procedures. Although the particular devices are approved by the FDA, they are approved for a very specific use which is not the performance of vaginal rejuvenation procedures. What is important for med spas and other health care professionals to understand is that such “off-label use” is subject to the oversight of their medical boards.

Therefore, med spas and their medical directors that are performing vaginal rejuvenation or are interested in providing vaginal rejuvenation should take this opportunity to review how they are or will be performing these procedures.

Not only should the physicians or medical directors responsible for performance of the procedure be properly trained and qualified for it specifically, but they should also have a good understanding of any available scientific and clinical data relating to the procedure in order to, in their professional judgment, determine it safe for patients. In addition, they also need to confirm they are meeting the supervision required of those health care practitioners providing the medical services.

Finally, they need to ensure patients are being fully informed and understand the risks about the procedure and that all information communicated satisfy state medical board rules and laws, including those relating to advertising.

More more information on this topic listen to the episode of AmSpa's Medical Spa Insider podcast detailing the issue.

Alex Thiersch, JD,
Founder/Director
The American Med Spa Association

Micheal Byrd, JD,
Partner
ByrdAdatto

Brad Adatto, JD,
Partner
ByrdAdatto

Tags:  Med Spa Law 

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Med Spa Law: FBI Raids and Anti-Kickback Settlements in Dallas Show Increased Enforcement

Posted By Administration, Friday, August 10, 2018

By Brad Adatto, JD, Partner, ByrdAdatto

Legal enforcement has been a big topic among med spas across the country recently, and that includes Dallas. During the last 12 months we have covered a wide range of articles on significant litigation by the government and the commercial payors challenging how providers submit bills. The allegations have ranged from completely fabricated bills to overpayment of fees for out-of-network services.

The civil litigation has involved United Healthcare’s allegations against Next Health, LLC for engaging in fraudulent activity, Quest Diagnostics’ settlement of a whistleblower lawsuit; and Blue Cross Blue Shield of Mississippi’s suit against a community hospital alleging it violated its contract for overpayment and recoupment of claims.

This May, the Dallas area health care industry had two new breaking enforcement stories. The Dallas Morning News reported on an FBI raid at a Dallas-based healthcare management company. The FBI has not provided any insight as to the reason for the raid, and the company has denied any wrong doings.

That same week, the Dallas Morning News broke a separate story of federal authorities settling a civil suit with a physician for allegedly being paid kickbacks by a Dallas-based lab. Federal authorities believe that the lab used a “sham investment model” to make payments for blood and urine screens. The lab was not a part of the settlement agreement, and no allegations have been made against it.

With these types of allegations, and heightened enforcement by the federal government, parties should ensure they understand the implications of the federal anti-kickback statutes, the federal travelers act, and wire fraud rules because the federal government is using these laws to pursue providers. Providers must scrutinize all their health care related investments, be conscious of these cases, and be mindful that any arrangement they enter into must be compliant with both state and federal laws, in both form and substance. (AmSpa members: check your state’s medical aesthetic legal summary for more information on the legal regulations in your state.)

For more information on your state’s laws and regulations, attend an AmSpa Medical Spa & Aesthetic Boot and be the next med spa success story.

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.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Law 

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Potential Legal Issues With Your Med Spa Website

Posted By Administration, Thursday, August 9, 2018

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

Does your med spa website meet all your local laws and regulations? According to the 2017 Medical Spa State of the Industry Report, a website is the most frequently used marketing tool for med spa practices. If you don’t have one, you’re losing out. A very common mistake being made by med spas across the country, however, is the failure to create and maintain a website that accurately reflects and realistically represents the business structure and ownership of the med spa.

Due to recent substantial growth in the med spa industry, regulatory authorities in several states are cracking down on med spas that are, or appear to be, operating illegally. But just how are these state regulatory agencies obtaining information on the business operations and workings of med spas? And what information is leading investigators to believe a med spa is operating illegally?

Websites. Technology and social media has driven businesses, big and small, to use the Internet as a tool to provide information to their clients. Med spas are no exception. A majority of med spas across the county operate websites with information about their “team” of professionals, the services provided, specials and discounts offered and even explanations of the different treatments and procedures clients can purchase.

Many of these websites provide bios of the professionals that own and operate the med spa and perform medical procedures. But, unfortunately, in several instances those individuals are not licensed to practice medicine and thus, cannot perform medical procedures or own a medical practice. State regulatory authorities have caught onto this- and now they are enlisting investigators to examine med spa websites looking for signs of illegal ownership or the unauthorized practice of medicine.

For instance, in Illinois, the Department of Financial and Professional Regulation (“IDFPR”) has begun launching investigations against med spas based solely on their website content. (AmSpa members: check your state’s medical aesthetic legal summary for more information on medical advertising in your state.) The IDFPR, much like other state regulatory agencies, has an enormous case load and it is impossible for investigators to personally visit every med spa to investigate and determine whether the spa is in compliance with state laws. Instead, to save time and effort, investigators are tasked with reviewing the websites of med spas to obtain information on ownership, business structure, fee structure, staff qualifications, and services.

If the med spa website does not realistically reflect its business practices or falsely depicts a non-physician as an owner or co-owner of the med spa, it will quickly be on the IDFPR’S “radar” and the owners and employees associated with the med spa can face suspension of licenses, fines and penalties. Click here to read more about non-physicians owning med spas.

Although not all states have prohibitions against non-physician ownership of medical spas, most states prohibit fee-splitting between physicians and non-physicians. If a website advertises ownership by a non-physician and highlights a physician as a “medical director” for the med spa, it is likely that the non-physician owner is receiving patient fees and then splitting these fees with the physician on staff. This constitutes fee-splitting between the physician and the non-physician owner of the med spa and it is illegal.

To ensure that your med spa website is in compliance with state and federal laws and to avoid the widening “radar” of investigating state agencies, it is important to perform a careful review your website for any terms or titles that may be red flags. Although there is no script to follow in creating a flawless med spa website, here are a few essential pieces of advice:

  1. List the physician owner prominently on the website to show the physician’s involvement in the business;
  2. If you employ an advanced practice nurse or licensed nurse practitioner to consult with and treat patients under the supervision of the physician owner, include this individual prominently on the website to inform clients and potential clients of that individual’s involvement in patient care;
  3. Importantly, if employing a registered nurse or aesthetician as the med spa’s “go to” coordinator or office manager, bestow upon the individual a title that properly reflects his/her duties, responsibilities, and limitations.

As technology grows, websites and other forms of social media become increasingly important for med spas looking to grow their business and compete in the marketplace. Now is the time to reevaluate your med spa’s online presence and ensure that if you have a website, or plan to establish one that you are conforming to the law and using the website to help, not hurt your business.

To learn more about how to build and run a legal and successful medical spa practice attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Law  Med Spa Ownership 

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5 Med Spa Tips: Turning Your Staff Into a High-Performing Team

Posted By Administration, Wednesday, August 8, 2018

Sponsored Content: Venus Concept

Having an outstanding team in a medical spa or aesthetics practice is one of the biggest contributors to long-term success. Quality employees will impact everything from treatment results, to patient retention, to new patient acquisition, to retail sales and much more.

Every person working at your aesthetics practice plays an important role—from a full-time nurse injector to a part-time marketing intern. Boosting performance is always a priority, but it’s not always clear how to navigate the hiring, training, and team-building process so everyone is ready to keep your practice running smoothly and your customers feeling great.

If you’re wondering how to build a high-performing aesthetics team, then we’ve got you covered with these five key tips to hiring and training high-performing staff for your practice! 

1. Start Strong with a Solid Plan

Begin your team-building project by realistically assessing the number and character of distinct jobs that your practice needs to succeed. Your goal is to have the right number of people to serve all your clients without long patient waits. If practice is on the smaller side, the team might be made up of yourself, a direct treatment provider (maybe that’s you, maybe that’s another person), possibly an aesthetician or injector, and a receptionist. A larger practice might add multiple aestheticians, a medical director, a medical assistant, a practice manager, a care coordinator, and a marketing associate.

2. Be Extra Interview-Ready

To build a high-performing team, be patient with the hiring process—adding a weak member to the team will hurt morale and hamper the patient experience. Think about the kind of personalities and credentials that you’d like to join your team. Articulate the top priorities for a potential new hire. These could be professional skills, team style, leadership, customer service, or other qualities. Those key priorities are your guide through the hiring process; when it comes time for the interview, translate them into questions, and tailor them to fit the responsibilities of each role. Those questions will illuminate how the potential hire rates on the key attributes you identified, and indicate whether or not they’ll be an asset to your team.

3. Keep it Positive

The key to fostering a positive atmosphere? Lead by example! Greet each staff member each morning when you arrive, and say goodbye each evening before you leave. Arrive on time and show empathy. After all, this group spends around 40 hours together each week. Making those relationships meaningful will strengthen your team and your practice. If you create a workplace environment where employees are genuinely happy, patients will feel it, too.

4. Train Year-Round

Another important element to building up your team’s professionalism and dedication is ongoing training, and training can happen in a lot of different ways! Schedule a weekly half-hour training session or an afternoon of training once a month. If you use aesthetic devices, look for manufacturers that offer ongoing clinical education, so employees can use these devices to the best of their ability. Building employee expertise enhances your practice overall, so keep your staff up-to-date on industry trends and new procedures.

5. Lay a Good Foundation

Creating and maintaining a high-performing team for your aesthetics practice may be simple, but it certainly isn't easy. It requires commitment on your part. It's difficult to create or sustain a healthy team environment if employees do not feel protected or valued in terms of payment or support for their labor. Start with strong fundamentals like fair wages and realistic benefits, and ensure that these are taken care of before all else. Be consistent and be equitable, and make sure that your bases are covered from day one in terms of fair pay and labor practices.

Still unsure about where to start and how to make the best impact? Don’t worry! Venus Concept partners with high-performing medical aesthetics clinics in more than 65 countries, and has developed a report specially designed to help your practice succeed.

Download the free report, How to Create (and Maintain) a High-Performing Team for Your Aesthetics Practice, to learn more about what makes a great aesthetics team. 

Download Now

Tags:  Business and Financials  Med Spa Ownership  Sponsored Content 

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Can Nurse Practitioners Own a Medical Spa in Massachusetts?

Posted By Administration, Tuesday, August 7, 2018

By Alex R. Thiersch, JD, Founder/Director, The American Med Spa Association (AmSpa)

The question of who can own a med spa is always one of the most common with medical aesthetic practices, and in Massachusetts it can be a tricky one because of the nature of the laws in the state. Massachusetts is one of a few states that has a clinic licensure statute—a comprehensive regulation that outlines a process by which a person or organization other than a physician or a physician-owned company can own a health care facility, such as a medical spa.

In the past, we at AmSpa and ByrdAdatto have worked with companies in the commonwealth to obtain clinical status for their businesses. However, approximately a year ago, we were informed that in some cases, this process may not be necessary.

“We reached out [to the Massachusetts Department of Public Health] because this potential client had said that according to their conversations with the department of health, as a nurse practitioner (NP) licensed in Massachusetts, they do not have to get a license to own a clinic,” said Renee E. Coover, JD, associate at ByrdAdatto. “That was flying in the face of everything that we had been told by the department of health—they said if you’re a non-physician, you must have clinic licensure in order to operate as a medical spa.”

When ByrdAdatto reached out to the Department of Public Health, it was told that in the opinion of the department’s legal counsel, an NP does not need to obtain a clinic license to own a medical spa. However, since this was merely the opinion of one person, the firm felt uncomfortable telling clients that such a course of action was legally sound.

“If they went to the department of health and they got the same answer, we would be fine, but if they happened to talk to someone else who said, ‘No, that is not the case,’ we were fearful we were going to give out incorrect information,” Coover says. “We’re going to reach back out to the department of health, because at this point, I don’t feel as confident giving information one or way or the other as to really what the law says when it comes to clinic licensure.”

As it stands, though, this issue may be moot, because Massachusetts law states that NPs require physician supervision in order to have a prescriptive practice.

“In light of that requirement, it would be difficult at this point to say an NP could own their own practice, because if they’re going to be prescribing anything—Botox, fillers, etc.—all of those types of treatments are going to need a prescription,” Coover explains. “They’re still going to require physician supervision. Without that prescriptive authority, I don’t know really how they would be able to independently have this medical spa.”

However, Massachusetts Senate Bill S.1257, which is currently in committee, would, if passed, remove the requirement for physician supervision for an NP prescriptive practice. If this bill passes, NPs could theoretically operate a practice completely independently of a physician. This, in turn, raises some questions about how an NP who owns a practice would be able to market it—is it really “medical” if there’s no physician involved?—but these are issues that will need to be addressed when and if the bill passes.

See the process for clinic licensure in Massachusetts in the video below:

For more information on medical spa law attend AmSpa’s Medical Spa & Aesthetic Boot Camp in Boston September 15–16 where you’ll learn the keys to build and run a legally compliant and profitable medical spa practice. See the full 2018 Boot Camp schedule to find a Boot Camp near you and be the next med spa success story.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Ownership 

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3 Reasons Med Spa Industry Growth is Only Just Beginning

Posted By Administration, Friday, August 3, 2018

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

The med spa industry is booming, but is this growth a fad or does it represent a long-term business opportunity?

There are few industries with as much potential as the med spa industry. When you look at the age demographics in relation to the advancements in technology being used in the medical spa industry, it is easy to see why. AmSpa’s 2017 Medical Spa State of the Industry Report takes a deep dive into industry trends, but here we examine three factors behind the industry’s explosive growth: technology, social media, and population trends.

Technology

Technology is key to current med spa growth because in the past 15 years, advancements in non-surgical (i.e. non-invasive) treatments that make people look and feel better about themselves made these treatments widely available and affordable. Botox injections, laser resurfacing, and body contouring have allowed people to keep their youth without going to the gym or undergoing expensive surgery with substantial downtime. As long as technology allows people to turn back the hands of time in an easy and (relatively) pain free manner, there will be a market.

Social Media

Because social media has become so pervasive, many people are more comfortable with the idea of receiving a cosmetic treatment. Seeing videos of procedures, oftentimes live with their favorite social media personality, lessens the stigma and uneasiness associated with receiving a med spa treatment. People often show up for treatments without any questions or reservations because they’ve experienced the procedure already through social media.

AmSpa members should check their state’s medical aesthetic legal summary for more information on a med spa’s patient privacy responsibilities with regard to social media.

Millennials and Beyond

Finally, the rise of the millennial and post-millennial population, combined with aging Gen X’ers, has created a perfect storm for the med spa industry. While the majority of med spa clients are in their mid-thirties to forties, the millennial population has shown a willingness to spend money on themselves, their appearance, and experiences. Med spas are creating a perfect environment for this population by making their environments an exclusive “experience” that makes clients feel special. And given that Millennials are only just starting to purchase med spa treatments and are poised to take over as the largest percentage of the U.S. population, imagine what the med spa market will look like in, say, 10 years when Millennials are actually showing signs of aging? Right now, Millennials go to med spas for ‘preventative’ treatments, i.e. to stop the wrinkles from ever forming.

Moreover, the generation behind the Millennials (called “post-millennials” or “Gen Z”) is even bigger than the Millennial population. Accordingly, there is serious potential for the medical spa market to continue to grow for years to come.

Attend an AmSpa Medical Spa & Aesthetic Boot Camp to find out how to build your practice legally and set your business up for long term, sustainable success.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Trends 

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Three Ways Med Spa Retail Sales Can Transform Your Practice

Posted By Administration, Thursday, August 2, 2018

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

Selling retail products like skin care or other items is often an afterthought in medical spa practices. While treatments and procedures will always be the bread and butter of your practice, retail product sales have a vital place in the overall success of your business.

Treatment Results

Stellar treatment results also increase the rates of customer retention, and offering skin care products that pair with your treatment menu can improve your patients’ procedure outcomes.

“Healthier skin responds better to treatment,” says Nealy Skeldon of Environ Skin Care. “The healthier the skin the better the result.”

Skeldon advises creating packages on your menu of treatments with skin care products bundled in to give your patients the best treatment results, and to increase their likelihood of returning.

Retention Rates

Client retention is hugely important for many reasons. For instance, it’s both easier and less costly to retain current customers than attract new ones. Additionally, repeat customers will spend from 20% to 60% more than new customers, and their spend per visit will increase the more they return as you continue to build trust.

There are many ways to increase retention in your medical spa but, according to Terri Wojak of True U, one of the easiest is through retail skin care sales. She noted that, on average, a client who does not purchase a product with their service returns only 10% of the time. Those who purchase one product return 30% of the time and the retention rate for clients who purchase two products can be as high as 60%.

Properly integrating a home-care plan with your patients can pay huge dividends as they continue to return to you.

Profit Margins

 As industry expert Bryan Durocher of Durocher Enterprises states, “So many people are in touch with top-line revenue and not their bottom-line profitability.”

After factoring in the cost of consumables, labor, electricity, and other details, the profit margin on many medical spa treatments can typically hover around 10%. Retail products, however, can yield a margin of up to 40%, according to Wojack.

For information on how to integrate retail skin care into your business attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Ownership 

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How the New California Privacy Act Affects Med Spa Practices

Posted By Administration, Wednesday, August 1, 2018
Updated: Wednesday, August 1, 2018

By Brad Adatto, JD, Partner, ByrdAdatto

Med spas and other aesthetic practices should be aware of the new California Consumer Privacy Act of 2018 recently passed and signed into law. With seemingly daily reports of data breaches or improper sharing of user data, consumer privacy is a growing concern. California is the latest State to take action to protect consumers’ personal information and has passed a law that provides strong and broad protections to do so. Signed into law on June the 28, 2018, the California Consumer Privacy Act of 2018 (“Privacy Act”) creates some of the strongest consumer privacy protections in the nation.

New Privacy Act Details

The Privacy Act creates a right for consumers to

  1. Request that businesses disclose what information they have collected, sold, or shared on them,
  2. If they so choose, to have that collected information deleted, and
  3. To proactively opt-out of future data collection, selling, and sharing.

These protections in turn create numerous compliance, notice, and penalty issues for businesses who collect information from California residents.

Businesses subject to the Privacy Act will need to provide proper notice of the types of information collected and the rights of the consumer under the act before any information is collected. Businesses also will need to ensure that their data collection and use practices involve only the types of information and uses that have been properly disclosed to the affected consumer.

Additionally, businesses will need to have trained personal to accept, verify, and respond to consumer requests within the statutory deadlines. And finally, businesses subject to the Privacy Act will need to have data systems capable of securely storing the information while providing for rapid and accurate access for requests, and to delete the information if requested.

Additional Details Regarding Patient Privacy

Medical businesses who are covered under the Health Insurance Portability and Accountability Act (“HIPAA”) or California’s Confidentiality of Medical Information Act (“CMIA”) have additional hurdles to overcome. The Privacy Act exempts “protected” or “health information” that is already covered under the prior laws. However, medical businesses will need to determine what information they have and comply with the Privacy Act for other types of information not covered by HIPAA or CMIA.

The safe and accurate handling of information and consumer requests will be critical to medical practices in particular as the Privacy Act creates substantial penalties for failure to maintain compliance, mishandling of information, and failure to respond appropriately to consumer requests. Luckily medical practices in California have some time to learn more about what is covered before being subjected to penalties, as the Privacy Act is slated to take effect on January 1, 2020.

Read the full text of the law here. If you have concerns on how the California Consumer Privacy Act of 2018 may impact your business consult a healthcare attorney familiar with California law.

AmSpa members may take advantage of their annual compliance consultation with the business, healthcare, and aesthetic law firm of ByrdAdatto. Become a member today to gain access to business and legal compliance tools to keep your practice profitable and on the right side of regulations.

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.

Tags:  Med Spa Law 

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The Dangers of Med Spas Purchasing Overseas Botox

Posted By Administration, Tuesday, July 31, 2018

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

Med spas purchasing Botox or other drugs from legitimate overseas sources in order to save money open themselves to significant legal risks. For instance, in June 2018, Oregon-based physician Brenda Roberts had her medical license revoked for obtaining and using prescription medication from foreign countries. Roberts was a family practice doctor who began administering Botox treatments at her home on the side. She wasn’t necessarily doing anything improper in terms of patient care, and she was keeping appropriately detailed records on her patients, but after Allergan noticed that she was having Botox sent to her home and cut off her account, she began buying Botox from United Pharmacies, a “rogue pharmacy” that operates outside of U.S. Food and Drug Administration (FDA) governance. FDA agents went through her trash and found that she had used Botox that was intended for sale in Europe.

Parallel Importation

Roberts was participating in a practice called parallel importation. In countries such as the United Kingdom, Germany, France, Sweden, and Canada, government regulates the cost of pharmaceuticals. Broadly, these measures are designed to prevent drug manufacturers from charging too much for what those governments consider essential medicine, but they also apply to pharmaceuticals used for elective procedures such as those offered by medical spas, including Botox.

In the U.S., however, drug manufacturers essentially can charge whatever they feel the market will bear for their products, and that price is invariably much higher than what is charged in other countries. In response, licensed dealers in countries where cost controls are enforced sell their products to customers in the U.S. at prices that are up to 50% less than what the buyers would have to pay if they were purchasing the drugs directly from the manufacturer.

This transaction benefits both parties. The buyers get legitimate pharmaceuticals for much less than they would have to pay if they were buying directly from the manufacturers, and the dealers can make a decent profit simply by marking the product up slightly. These are not cheap, counterfeit pharmaceuticals like the ones that are typically manufactured in China that have flooded the medical aesthetics market in recent years; these are the same drugs that are approved by the FDA and sold in the U.S.

Legal Concerns

However, while parallel importation is broadly legal in the U.S.—the Supreme Court ruled that to be the case in a 2013 case involving textbooks—this case demonstrates that the distribution of drugs that are not explicitly intended for use in the U.S. is still absolutely illegal, and that the FDA and the U.S. Drug Enforcement Agency (which also participated in the investigation) are taking cases such as this one extremely seriously. There hasn’t been a great deal of enforcement yet, but this case demonstrates that the issue is absolutely on the agencies’ radars.

Despite the relatively minor risk of being caught, ByrdAdatto and AmSpa steadfastly believe that medical aesthetics practices should not participate in parallel importation. The potential consequences clearly outweigh the cost savings. If a practice’s profitability depends on getting 30% off Botox, it needs to re-evaluate the way it does business. Practices should remain compliant with the FDA and other regulatory agencies, regardless of whether a drug is overpriced. It is absolutely possible to run a medical spa practice that is both financially sound and compliant with all laws and regulations. Learn the keys to running a medical spa practice profitably and legally at an AmSpa Medical Spa & Aesthetic Boot Camp. Consult with your healthcare attorney if you need more information. AmSpa members can take advantage of their annual compliance consultation with the business, healthcare, and aesthetic law firm of ByrdAdatto.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Law 

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