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Health Law Highlights

FDA Warns Against Unauthorized Fat-Melting Injection Treatments

From NBC News, by Berkeley Lovelace Jr.:

  • The FDA has issued a warning about the dangers of using unauthorized versions of fat-dissolving injections, citing reports of severe side effects such as scarring, infections, and skin deformities.
  • These injections, also known as lipolysis injections, are typically used in problem areas such as the chin, legs, upper arms, and abdomen.
  • While the FDA has approved one injection, Kybella, from Kythera Biopharmaceuticals, there are many unapproved versions being sold at clinics and med spas, as well as online.
  • Common ingredients in these unapproved injections, such as phosphatidylcholine and sodium deoxycholate, have not been approved by the FDA.
  • The FDA advises against purchasing fat-dissolving products from websites, as they may be ineffective and carry a risk of severe side effects. If experiencing side effects from these injections, it is recommended to see a healthcare provider.
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Health Law Highlights

Woman’s Death After IV Therapy Leads to License Suspension for Frisco Anesthesiologist

From D Magazine, by Will Maddox:

  • The Texas Medical Board suspended Frisco anesthesiologist Dr. Michael Gallagher after a mother of four died in July at a med spa for which he was the medical director. 
  • She died after receiving an IV treatment administered by the non-licensed owner of the business. 
  • The med spa did not have protocols or policies for the staff’s IV therapy administration. 
  • There was only an unsigned agreement between Gallagher and the med spa. 
  • There were no licensed medical staff or experienced personnel onsite while IV therapy was being administered. 
  • The treatment the patient received before dying included vitamin B complex, vitamin B12, TPN electrolytes, and ascorbic acid. TPN electrolyte solution requires a prescription and is known to cause complications. 
  • IV therapy is a growing market, but complications can be deadly because it is often administered in medical spas with little medical supervision.
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Texas Med Spa FAQ

What is a med spa?

The American Med Spa Association defines a medical spa as a hybrid between an aesthetic medical center and a day spa” with four core elements: (1) the provision of non-invasive (i.e. non-surgical) aesthetic medical services; (2) under the general supervision of a licensed physician; (3) performed by trained, experienced and qualified practitioners; (4) with onsite supervision by a licensed healthcare professional. AmSpa – Med Spa FAQ

While that definition is technically accurate, it obscures the point that because med spas offer medical services, they are considered medical practices in Texas and must comply with the rules and regulations that apply to traditional doctor’s offices.

What kinds of services do med spas offer?

In addition to providing aesthetic cosmetic treatments common in many spa settings, med spas provide services that cross the line into the practice of medicine. A small sample of these services include:

  • Laser Hair Removal
  • Botox injections and other dermal fillers
  • IV infusions
  • Platelet-Rich Plasma injections
  • Hormone therapy
  • Cosmetic surgeries

The Texas Medical Board refers to these types of services as Nonsurgical Medical Cosmetic Procedures and requires that an appropriately trained physician, or properly supervised midlevel practitioner, perform an appropriate patient assessment and issue an order for the medical cosmetic procedure. Title 22, Texas Administrative Code, Section 193.17, Nonsurgical Medical Cosmetic Procedures

What legal structure must med spas have?

Because med spas are medical practices, they must follow the requirements of Texas law regarding professional entities. Medical practices can only be structured as professional limited liability companies (PLLC) or professional associations (PA). Texas Business Organizations Code, Section 301.003(3)

They may not be formed as corporations or regular limited liability companies (LLC).

Who can own a med spa?

Medical services can only be offered through professional entities owned by physicians. Texas Business Organizations Code, Sec. 301.004, 006-007 In certain circumstances, non-physicians can co-own a medical practice with the physician. The only allowances are for podiatrists, chiropractors, optometrists, and sometimes physician assistants. Texas Business Organizations Code, Sec. 301.012

That means that nurse practitioners or unlicensed persons cannot form a “partnership” with physicians to own a med spa. Said another way, unless you are a physician, chiropractor, optometrist podiatrist, or physician assistant (in limited situations), you cannot own a med spa. This too is a violation of the Corporate Practice of Medicine.

Can a non-physician co-own a med spa with the physician?

In certain circumstances, non-physicians can co-own a medical practice with the physician. The only allowances are for podiatrists, chiropractors, optometrists, and sometimes physician assistants. Texas Business Organizations Code, Sec. 301.012 That means that nurse practitioners, registered nurses, estheticians, or unlicensed persons cannot form a “partnership” with physicians to own a med spa. Said another way, unless you are a physician, chiropractor, optometrist podiatrist, or physician assistant (in limited situations), you cannot own a med spa. This too is a violation of the Corporate Practice of Medicine.

Can a dentist be the “medical director” of a med spa?

I’ve seen mention that the Texas State Board of Dental Examiners allows dentists to use Botox for dental esthetic and dental therapeutic purposes. I cannot confirm that policy, but it would not be surprising as there are several therapeutic dental uses for Botox: high lip lines, Temporomandibular Joint Disorder, Bruxism, and dentures no longer fitting due to shifting jaw muscles. However, Botox for facial cosmetic purposes would not be in a dentist’s scope of practice.

In my view, dentists can only prescribe Botox and fillers for dental purposes. I do not think dentists can provide Botox for purely cosmetic purposes. The other issue is that since cosmetic Botox is a medical service, and dentists are not medical doctors, they cannot own or co-own a medical practice. Neither are dentists qualified to serve as “Medical Director” since they are not licensed to practice medicine in Texas.

What are some of the risks of a non-compliant med spa?

It is a violation of Texas’s Corporate Practice of Medicine doctrine for corporations or standard LLCs to provide medical services. Doing so could bring civil and criminal penalties. Texas Occupations Code, (Medical Practice Act), including sections 155.001, .003, 157.001, 164.052(a)(8),(13), and 165.001, .051, .101, .151, .156

Is the physician required to be on-site or at mid-level required to be on-site?

Either the midlevel or the physician can do the good-faith exam via telehealth or in person. They must be the ones to write the order for the medical procedure.

How often should a med spa perform good faith exams on patients?

At a minimum, a Good Faith Exam (GFE) should be performed annually, but may be required more often depending on the circumstances.

The good faith exam should be performed on any patient receiving treatment for the first time. From this GFE, the provider develops a treatment plan which will often include multiple treatments over several sessions. A GFE does not need to be performed for each session included in that treatment plan.

With that said, a new GFE should be performed:

  • If a patient seeks additional services not anticipated during the initial GFE, or not included in the initial treatment plan;
  • The patient discontinues the treatment plan, but then desires to resume treatment after a substantial delay; or
  • A patient’s health changes materially, either during the course of a treatment plan or thereafter.

There is no hard and fast rule. It is a question of the applicable medical standard of care. When in doubt, a physician or midlevel should decide if a GFE is required.

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Texas-Sized Pitfalls for Med Spas

Med spa growth across Texas and the nation continues to increase. The American Med Spa Association (AmSpa) found in 2018 that there were 5,431 med spas in the United States with average revenue of more than $1.5 million. That was up by 9% from the year before.1

Revenues during 2020 were strong relative to other industries. While 52% felt the impact and project revenues below $1 million, 37% projected revenues between $1-4 million.2

The outlook for the future is bright. Sixty-two percent (62%) of med spas owners expected their revenue in 2021 to increase by more than 10%:3

Many respondents expressed optimism for the post-pandemic future, with some citing the so-called “Zoom effect” as a reason why more people than ever before might seek out aesthetic services.

It’s no wonder Texas is experiencing a growth in med spas. Unfortunately, there is a lot of misunderstanding about med spas. While people rush to open practices and reap the financial rewards, many (or most) are not following Texas law. Starting a med spa without the right knowledge, structure, ownership, and licensure could subject you to legal liability, civil and criminal penalties, cease and desist orders from the Texas Medical Board, breach of contract, and a host of other unanticipated risks.

What are Med Spas?

The American Med Spa Association defines a medical spa as a hybrid between an aesthetic medical center and a day spa with four core elements: (1) the provision of non-invasive (i.e. non-surgical) aesthetic medical services; (2) under the general supervision of a licensed physician; (3) performed by trained, experienced and qualified practitioners; (4) with onsite supervision by a licensed healthcare professional.4

While that definition is technically accurate, it obscures the point that because med spas offer medical services, they are considered medical practices in Texas and must comply with the rules and regulations that apply to traditional doctor’s offices.

In addition to providing aesthetic cosmetic treatments common in many spa settings, med spas provide services that cross the line into the practice of medicine. A small sample of these services include:

  • Laser Hair Removal
  • Botox injections and other dermal fillers
  • IV infusions
  • Platelet-Rich Plasma injections, including O-Shot
  • Hormone therapy
  • Cosmetic surgeries

The Texas Medical Board refers to these types of services as Nonsurgical Medical Cosmetic Procedures and requires that an appropriately trained physician, or properly supervised midlevel practitioner, perform an appropriate patient assessment and issue an order for the medical cosmetic procedure.5

I once had a client physician who was the supervising physician for a med spa. Unbeknownst to him, the med spa did not hire a midlevel practitioner and was allowing a registered nurse (RN) to “order” and administer Botox injections. He immediately resigned from the clinic and reported the conduct to the Texas Medical Board. Last I heard, the TMB was imposing civil penalties against the clinic.

There are also specific licensing requirements associated with some of these services. For example, clinics owned by non-physicians that provide laser hair removal services must be licensed by the Texas Department of License and Regulation. That licensing requires specific training for the employees and contracts with designated and supervising physicians. Because the laser equipment emits radiation, it must also be licensed by the Radiation Control Program of the Department of State Health Services.6

These licensing requirements cut both ways. If a person with an esthetician license is working in a medical office, the medical office is required to have a salon license. 7

Legal Structure for Med Spas

Because med spas are medical practices, they must follow the requirements of Texas law regarding professional entities. Medical practices can only be structured as professional limited liability companies (PLLC) or professional associations (PA).8 They may not be formed as corporations or regular limited liability companies (LLC).

Time and time again, I see “med spas” offering medical services through corporations and standard LLCs. Doing so is a violation of the Corporate Practice of Medicine doctrine and could carry civil and criminal penalties. 9

Ownership of Med Spas

Equally important, medical practices can only be owned by physicians.10 The only exceptions are podiatrists, chiropractors, optometrists, and sometimes physician assistants. 11 That means that nurse practitioners or unlicensed persons cannot form a “partnership” with physicians to own a med spa.

Said another way, unless you are a physician, chiropractor, optometrist podiatrist, or physician assistant (in limited situations), you cannot own a med spa. This too is a violation of the Corporate Practice of Medicine.

Physician Supervision

In addition to the ownership requirements, nurse practitioners and physician assistants (“midlevel practitioners”) must be supervised by a licensed physician as required by the Texas Medical Practice Act and the rules of the Texas Medical Board.12

This supervision is memorialized in a Prescriptive Authority Agreement or Collaboration Agreement, which documents the procedures and prescriptions the physician is delegating to the midlevel to perform.13

If the med spa is jointly-owned by another authorized person (chiropractor, podiatrist, etc.), the physician generally will also serve as the Medical Director for the practice and be responsible for all medical protocols and policies.

Danger for the Uninformed

These are just a few of the compliance issues Texas med spas must satisfy. There are also in-office and website disclosure requirements, registration requirements, reporting requirements, restrictions on the type of marketing or advertising the practice can engage in. The list goes on and on.

If you need help forming a med spa, or if you have already formed one and need assistance bringing it into compliance, please don’t hesitate to contact me at 214-855-3040 or wemmert@ccsb.com.


  1. AmSpa – 2019 Medical Spa State of the Industry Report ↩︎
  2. AmSpa Releases Results of AmSpa 2020 Medical Spa Industry Short Survey – COVID-19’s Impact ↩︎
  3. AmSpa Releases Results of AmSpa 2020 Medical Spa Industry Short Survey – COVID-19’s Impact ↩︎
  4. AmSpa – Med Spa FAQ ↩︎
  5. Title 22, Texas Administrative Code, Section 193.17, Nonsurgical Medical Cosmetic Procedures ↩︎
  6. Texas Department of License and Regulation – Medical Spas Frequently Asked Questions ↩︎
  7. Texas Occupations Code, Section 1602.251(c) ↩︎
  8. Texas Business Organizations Code, Section 301.003(3) ↩︎
  9. Texas Occupations Code, (Medical Practice Act), including sections 155.001, .003, 157.001, 164.052(a)(8),(13), and 165.001, .051, .101, .151, .156 ↩︎
  10. Texas Business Organizations Code, Sec. 301.004, 006-007 ↩︎
  11. Texas Business Organizations Code, Sec. 301.012 ↩︎
  12. Title 22, Texas Administrative Code, Chapter 193, Standing Delegation Orders ↩︎
  13. Title 22, Texas Administrative Code, Section 193.7, Prescriptive Authority Agreements Generally ↩︎