Keeping Elective Services Under One Roof – Primary Care Meet MedSpa

Carlos H. Arce, Esq. / Chase E. Howard, Esq.

Sustaining a healthcare business in today’s medical industry calls for both ongoing innovation and quite a bit of ingenuity. The question of what can be done to enhance patient retention while keeping patients interested and loyal to a practice comes down to what is legally permissible from a compliance standpoint. A prime example of value add for an existing practice are the benefits that patients in the geriatric population are often offered, everything from cardiologists, chiropractors, physical therapists, dentists, orthopedic, pulmonologists and most recently, to med spa services.

Vendor Status

Allowing specialists to treat patients in a practice has always been a form of benefit to patients. Assuming the patients require a medical service which is medically necessary, they are treated. The obvious key is making sure it is done legally. Under the federal and state self-referral laws, it is imperative to comply with certain exceptions when entering a referral arrangement between providers. The most accurate away to ensure legal compliance when offering specialist services in apractice is via the “Rental of Office Space” exception. Space is leased to the specialist on a basis which accounts for the guidelines, the specialist provides services, the insurance pays them or the patient pays them, and the patient receives rounded care.

But can this be done for elective procedures, such as MedSpa’s? The answer is yes. Most patients 18 and over are seeking additional elective medical procedures, from IV hydration to Botox. Primary care providers may be able and qualified to perform some of these services, but consideration must be paid regarding taking on the risk of performing services which may be outside of one’s wheelhouse.

Bringing in a med spa vendor who can provide services to an existing patient base sounds like a wonderful patient retention tool. If the legal parameters surrounding this arrangement are followed, providers not only can be legally compliant, but can also add a retention benefit to their practice.

Mobile MedSpa

With the push in healthcare to make services mobile, medspa owners may be wondering how to transport the business to conduct services elsewhere. The short answer is finding the right relationship to support the opportunity. Which services could a medspa offer on a “mobile” basis? The answer is, it depends. Generally, services provided in home to patients are allowable but might require a home health agency license depending on the services. Services provided at another clinical location, such as a primary care practice, require very little in the way of licensure. Specifically, a Medspa could send its providers to another location on a limited basis to service that practice’s patients so long as the providers are properly “supervised” and the patients are properly billed. The providers could utilize the other clinic’s physician for supervision, eliminating the need for any specialty supervision as required by Florida law and could utilize extended staff for patient intake, room prep, and check out.

The biggest hurdle for this arrangement would be the compensation arrangement, which, as described above, would require strict compliance with the law to ensure no illegal referral schemes or fee-splitting occurs.

Summary

With multiple MedSpa’s and Aesthetic clinics popping up through out the country, why not considering subleasing space rather than adding that additional unnecessary overhead. Some MedSpa’s will inevitably be better off treating in their private space, but that doesn’t mean it’s the only way these added services can be accomplished.

Are Essential Oils FDA-Approved?

fda stem cell business

The FDA does not regulate essential oils, just like it doesn’t regulate herbs or supplements. That means that there is no FDA approval for any essential oil.

It also means that there are no real regulations on the companies that produce essential oils. As long as they don’t market essential oils as if they are medicine or a cure for any issue, they can otherwise say what they like about the products.

But if they say that their product is FDA-approved to do something specific, that is incorrect and they are open to fines and could be shut down.

If your clinic or company sells essential oils, it is important to ensure that you remain in compliance with the law when it comes to marketing.

List of FDA-Approved Essential Oils

Because the FDA does not regulate essential oils, there is no such thing as a list of FDA-approved essential oils.

The FDA regulates cosmetics and drugs, so unless an essential oil is added to a cosmetic product or used in the creation of a medication, it will not fall under the jurisdiction of the FDA.

It’s important to note that it is illegal for an essential oil company or any purveyor to sell essential oils for medical use or as a treatment for any issue. The Federal Trade Commission regulates advertising claims and will intervene in the event that a company crosses the line or if there are complaints against the company.

Essential Oils in the GRAS Database

The FDA manages a database that houses a list of substances that have been determined to be “Generally Recognized as Safe.” There are some substances from which essential oils are made in this database along with a report.

For example, coconut oil is in the GRAS database, making it a safe base for essential oil products. It is important to note that the FDA has deemed all items on the GRAS list generally safe for consumption and that there is no toxic buildup for these items even when ingested in doses that are magnitudes larger than would be expected.

It does not necessarily consider their safe use topically. For example, clove oil is on the GRAS list and safe for consumption, but application of clove oil to the skin will cause inflammation, irritation, and a burning sensation.

Updating Your Essential Oil Marketing to Be Compliant With FTC & FDA Standards

The GRAS list is a continually expanding database to which more and more substances are added each month. New research is regularly done into the function of different essential oils topically and internally.

Florida Healthcare Law Firm can review marketing materials to ensure that they are in compliance with state and federal regulations and protect businesses from lawsuits brought by the government or civilly.

Contact us today to set up a consultation.

Medical Spa Requirements Florida

Florida Healthcare Law attorney

Medical spas are a great source of revenue. They can be a unique way to serve clients that are local residents as well as those who are visiting Florida.

Florida is home to many seniors who benefit from med spa services. And out-of-town guests often seek a spa day while on vacation in the state.

Around the world, the med spa market was estimated to be worth about $19.3 million in 2022. Its growth is expected to almost double by 2028.

Before opening a med spa, it’s important to know a little about what is allowed, who can own a medical spa, and how to stay compliant with Florida law.

Who Can Own a Medical Spa in Florida?

Florida law states that anyone can own a medical spa. The law requires that all services be provided by licensed medical professionals who have current certifications in the procedures they are providing.

Essentially, as long as the nonmedical personnel has no input into what services are provided to patients, how they are offered, or which clients receive what treatments, they can run the backend of the business without crossing legal boundaries.

Do You Need a Medical Spa License in Florida?

If a medical spa takes only cash payments (not insurance plans), the owner needs no other licensure in order to run the business.

However, it is essential that every medical provider on staff only perform procedures that are within their scope of practice. For example, if the person is doing microdermabrasion, they need to be licensed and certified to do so. The same goes for other common nonsurgical procedures, such as laser hair removal, injectable dermal fillers, and nonsurgical fat reduction.

What Are the Laws Regulating Medical Spas in Florida?

Yes, there are laws regulating medical spas in Florida, and those laws are frequently changed and updated. The problem with attempting to stay in compliance with the shifts in legislation is that it can become a full-time job on its own.

When trying to run a business and take care of clients, it is almost impossible to immerse yourself in changing medical law at the same time.

The good news is that there is support available that can ensure you keep up with changing regulations without sacrificing time and attention from your business to do so.

Do You Need Help Opening a Medical Spa in Florida?

Florida Healthcare Law Firm is a boutique law firm serving the medical and dental community in southern Florida. No matter where your med spa is or will be located, we can assist you in getting the legal entity set up and help you to understand what is needed to remain in compliance. Call now for more information.

Aesthetic Clinics and Regulation – What’s Happening?

supervision requirements for medspa

supervision requirements for medspaBy: Chase Howard

Over the last few months, there has been a significant uptick in investigations in the “medical spa” space. The biggest points of enforcement have been in regards to supervision and scope of practice.

The various governing bodies have taken a more active role in ensuring that providers are providing services within their scope of practice as wells as enforcing the various supervision statutes.Continue reading

Supervision of Electrologists

By: Chase Howard

Changes are coming to the way Electrologists in Florida may be supervised when performing laser hair removal. For years, direct, on-site supervision by a physician was required in order to allow an electrologist to perform laser hair removal. Recently, the Board of Medicine and Electrolysis Council agreed to a rule change, altering the method of supervision to include telehealth.Continue reading

Medical Practices & MedSpa Startups: Corporate Considerations

medspa startupsBy: Chase Howard

Deciding you want to open your own medspa or start a medical practice is the first and most important step in creating something unique and building a brand. Understanding how to properly “start” that business from a legal perspective, and doing so correctly can be the difference between success and failure.

As a physician in a private, solo-practice, or the business owner of a medspa startup, proper strategy is key. Understanding your corporate structure, developing a business plan, and compliance with the laws will help eliminate pesky obstacles that will slow your growth.

When working with start-ups the following steps should be given plenty of time and attention.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

Physicians & Nurses in for a Long Ride on the Health Train

npsBy: Jackie Bain

Nearly half of U.S. States have already expanded the scope of nursing practice and several more are analyzing whether it is appropriate.  The debate between physicians and nurses regarding how much autonomy a nurse should be given is a political hotbed that will likely be revisited by the legislature in the near future.  Until that time, the Board of Medicine and the Board of Nursing will quietly continue to enforce the present requirements. Here’s how they stand today:

Under Florida’s current laws, in addition to the practice of professional nursing, an advanced registered nurse practitioner (“ARNP”) may perform acts of medical diagnosis, treatment and prescription. However, for the most part, such acts must be performed under the general supervision of a physician.  The nature of such a supervisory relationship should be identified in a protocol which identifies the medical acts to be performed and the conditions for their performance.Continue reading

Major Criminal Case in Palm Beach County Directed at Hormone Business

pharmacy billing

Telemedicine hormoneA trial underway in West Palm Beach will have serious impact on hormone replacement therapy (HRT) businesses around the state.  HRT businesses are exploding around the state and country.  The underbelly of the business exists where business owners do not approach it as a medical service deserving of the same seriousness (clinically and legally) as any other healthcare service.  Four of the doctors involved have already pled guilty to conspiracy charges and were placed on five years probation.  One of the doctors relinquished his license.

The allegations involved in the case shed light on some of the more nefarious aspects of HRT business, which in this instance include—Continue reading

Florida Medical Spas: Regulators Look Beyond the Surface

money syringeThere is no such thing as a “medical spa” in Florida.  True!  They are not uniquely licensed.  In fact, they are usually not licensed at all because (1) they are owned and operated by licensed healthcare professionals, and/or (2) they do not file claims for reimbursement with health insurers.  And they are not a regulated entity.

What then is a “medical spa”?  If you want the long answer, go here. The short answer is It’s simply a place where people receive traditional spa services (e.g. facials), plus many other medical procedures, typically focused on cosmetic services (e.g. hair removal, Botox).   It’s “medical” because of the nature of the services provided.  It’s “medical” because (ideally) physician supervision is woven into the business model.

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