Over the past week, the news of enforcement against two medical spas (“MedSpas”), including the arrest of a popular nurse injector and the clinic’s supervising medical director, has created panic within the MedSpa community. The enforcements occurred in the Texas communities of San Antonio and Spring, a city located north of Houston. On November 7, 2018, news broke that a San Antonio individual was accused of offering laser procedures and injections without physician supervision. (“Medical Board warns about lasers and injections without doctor supervision.”) The following day, on November 8, 2018, the Botox arrest occurred. It was reported that a licensed vocational nurse, or LVN, was arrested and charged in Spring in connection with offering Botox injections without a license. Prosecutors are alleging that as an LVN, she is not licensed to perform nonsurgical medical procedures without appropriate supervision and delegation. (“Nurse accused of unlicensed Botox injections at Spring spa.”) The clinic’s supervising medical director was arrested and charged with the unauthorized practice of medicine. (“Doctor at Spring medspa accused in illegal Botox case after nurse’s arrest.”)
Currently, we have limited facts about these allegations and are attempting to learn more of the details; but we have addressed the impact of these two incidents on the MedSpa industry and how you can avoid the same fate in a special AmSpa podcast entitled, “AmSpa Interviews ByrdAdatto Attorneys About Texas Botox Arrest.” We also wanted to take this time to review the rules governing the delegation of nonsurgical medical cosmetic procedures in Texas. These reports highlight two of the many regulatory requirements MedSpa professionals and owners must understand and comply with in order to avoid a similar outcome: scope of practice and supervision.
Texas is fairly liberal in who they allow to physically perform Botox and other injectable procedures. Anyone with proper training may inject Botox and other cosmetic injectables as long as it is under the written protocols, supervision, and delegation of a licensed physician. The Texas Medical Board has adopted Rule §193.17 (available here) to provide guidance to physicians who delegate these nonsurgical medical cosmetic procedures. The Rule applies to nonsurgical medical cosmetic procedures, including injections or the use of a prescription medical device by someone who is not otherwise licensed to perform the procedure and is not a physician, physician assistant (“PA”), or nurse practitioner (“NP”). The Rule includes 13 points that physicians must adhere to in properly supervising and delegating such a procedure to anyone other than a PA or NP.
- The physician is responsible for being properly and appropriately trained in the specific procedure(s) and keeping records documenting their training.
- Before the procedure is performed, the physician, or a PA or NP acting under the physician’s delegation, must perform an initial examination. This examination must include:
- taking a history;
- performing a physical exam;
- making a diagnosis;
- recommending treatment;
- developing a treatment plan;
- obtaining a patient’s informed consent;
- providing emergency and follow-up care instructions; and
- maintaining medical records and having signed and dated written protocols and standing orders for the procedure.
- Following the examination and diagnosis, the procedure can be delegated to another person as long as a PA, NP, or physician is on-site, or the delegating physician is available for emergency consultation and able to conduct an emergency appointment, if necessary.
- The physician, regardless of to whom they delegate, maintains ultimate responsibility for patient safety.
- The physician is also responsible for documenting and maintaining the patient records.
- The facility must have a quality assurance program in place, including mechanisms to identify complications, adhere to protocols, monitor the quality of treatments, a review and improvement mechanism for protocols, and ongoing training.
- The physician can delegate procedures only at a facility where the physician has either approved of that facility’s written protocols for the procedure or where the facility has developed their own protocols.
- The physician must also make sure that the delegated person has appropriate training in several areas related to performing procedures (see the Rule for details).
- The physician must have in place a written office protocol for the delegated person to follow in performing the procedure. This protocol must identify the delegating physician, criteria for the physician, PA, or NP to screen the patients, and description of appropriate follow-up care including for complications, injury, and emergencies.
- The physician must make sure that the delegated person follows the written office protocol.
- Patients must sign consent forms before receiving any treatment. The form must identify potential side effects, complications, and identity of who will perform the procedure.
- The delegated person who performs the procedure must have a name tag which discloses their name and credentials.
- The facility must have at least one person onsite who is trained in basic life support whenever a procedure is performed.
The elephant in the room from a compliance perspective is ownership of the MedSpa. Nurses, estheticians and business people commonly own MedSpas. Texas has strict laws regarding ownership of a business that provides medical services – only physicians and, with certain limitations, physician assistants, podiatrists, and chiropractors may own a MedSpa. The common reasons for non-compliant ownership are: (1) everyone else is doing it; (2) consultants giving improper advice; or (3) ignorance. Regardless of the reason, non-physician ownership is not compliant and the Botox arrest raises the stakes.
The sobering reality from the Botox arrest is this – orange jumpsuits are not reserved only for the non-compliant MedSpas who maim or kill a patient. The great news is that solutions exist to each of the compliance hurdles. If you have any questions on how to build and maintain a compliant MedSpa business, schedule a consult at email@example.com.