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Texas-Sized Pitfalls for Med Spas

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Photo by Atikah Akhtar on Unsplash

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 ↩︎

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Improper CBD Product Marketing Lands in FDA’s Crosshairs

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Photo by CRYSTALWEED cannabis on Unsplash

The FDA issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.

CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19. For instance, one company’s website quoted people who used CBD oil “as treatment” for various medical conditions, claiming positive effects. Another company marketed the use of CBD oil to treat medical conditions on social media, using several hashtags related to serious medical conditions.

The FDA considers these products “new drugs” under section 201(p) of the FD&C Act, and therefore they are not considered safe and effective for treatment of medical conditions as these companies promoted.

Source: Improper CBD Product Marketing Lands in FDA’s Crosshairs

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Federal Regulatory Compliance Issues Can Arise in State Court Matters

An interesting read regarding the use of federal regulatory compliance issues (e.g impermissible healthcare kickbacks) to support a state court tort claim.

The plaintiffs sued the manufacturer of a immunoglobulin infusion product alleging that the manufacturer improperly induced a physician to misdiagnose their condition by paying the physician impermissible kickbacks through bonuses and commissions. The plaintiffs did not assert Anti-kickback or Stark claims directly. Such claims must be brought as qui tam actions.

Instead, they alleged that the fact that the federal statutes prohibit such conduct illustrates that patient harm is a foreseeable consequence of the payment of kickbacks.

The gist is that these regulatory issues could find their way into your state court litigation case.

Source: Memorandum Order Denying Defendants’ Motion to Strike, Post v. AmerisourceBergen Corp., Northern District of West Virginia

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Private Schools and the Intersection of HIPAA and FERPA

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Photo by Element5 Digital on Unsplash

My wife works as an Administrative Assistant at a local private school. As you might expect, they take very seriously their responsibility to help stop the spread of COVID-19 in the community. As part of their efforts, they require students who were in direct contact with persons diagnosed with COVID-19 to quarantine at home, away from the other students.

The school does a good job of communicating with parents. They send out regular email with statistics on the number of students or faculty diagnosed with COVID-19 and the numbers currently quarantining. Of course, they don’t disclose any names or other identifying information because of privacy concerns.

As a school, are they legally not allowed to disclose that kind of information, or are they refraining because of a more general concept of privacy?

That question is not so easy to answer because it depends on the interplay of two federal statutes — HIPAA and FERPA. Most people know that HIPAA covers the privacy of medical records. The Family Educational Rights and Privacy Act (FERPA), on the other hand, protects the privacy of student educational records. One or the other, or neither, apply to schools.

As a general rule, HIPAA does not apply to schools. HIPAA applies to health care providers who exchange electronic information, health plans, and health information clearinghouse. Even if the school has a nurse on-site, it is usually not considered a health care provider. There are certain exceptions, but they are not common. For instance, a school that provides health care to students in the normal course of business, such as through its health clinic, is also a “health care provider” under HIPAA. However, many schools that meet the definition of a HIPAA covered entity do not have to comply with the requirements of the HIPAA Rules because the school’s only health records are considered “education records” or “treatment records” under FERPA.

FERPA is a Federal law that protects the privacy of students’ “education records.” FERPA affords parents certain rights regarding their children’s education records maintained by educational agencies and institutions and their agents to which FERPA applies. These include the right to access their children’s education records, the right to seek to have these records amended, and the right to provide consent for the disclosure of personally identifiable information (PII) from these records, unless an exception to consent applies.

FERPA applies to educational agencies and institutions that receive Federal funds under any program administered by the U.S. Department of Education. An educational agency or institution subject to FERPA may not disclose the education records, or PII from education records, of a student without the prior written consent of a parent or the student, unless an exception applies.

Private and religious schools at the elementary and secondary levels generally do not receive funds from the U.S. Department of Education and are, therefore, not subject to FERPA. Neither will HIPAA apply unless one of the uncommon exceptions exists. Of course, private schools should still be mindful of the privacy of their students and just because HIPAA or FERPA does not apply does not mean the school should make those disclosures. However, private schools do have more flexibility in handling these situations than do most public institutions.

Source: Joint Guidance on the Application of FERPA and HIPAA to Student Health Records