Since the summer of 2011, the Texas Medical Board has been considering adopting a new rule applicable to non-surgical, cosmetic procedures such as Botox or dermal filler injections. The proposal would create new standards and requirements applicable to physicians who perform or delegate the performance of such procedures. Currently, this area is covered by Chapter 157 of the Medical Practice Act which governs a physician's ability to delegate the performance of medical acts to a non-physician. This includes a person who is not licensed, such as a medical assistant, and individuals who are licensed but are not allowed to diagnose illness or create a treatment plan, such as a cosmetologist.
Underlying the Texas Medical Board's initiative is a concern that physicians have not been exercising sufficient control and supervision over the unlicensed persons performing delegated non-surgical, cosmetic medical acts. This includes allowing an unlicensed person to determine the need for the cosmetic procedure as well as deciding how this procedure was to be performed- i.e. how many Botox units to use and the selection of injection sites. In the reports submitted to the Board Committee drafting the new rule, Medical Board Staff have argued that this constitutes the unlicensed practice medicine.
Prior to the initial stakeholder's meeting weighing in on a proposed rule, the attorneys at my firm had represented a physician who had delegated filler injections to a medical assistant. The Board invited our client to an informal conference to address allegations that this constituted improper supervision and delegation. Based on our argument that the physician's actions were proper under Chapter 157's delegation provisions, the Texas Medical Board closed the case and convened the stakeholder's meeting.
The current version of the proposed rule would supplement the present requirements for physician delegation found in Chapter 157. The main change is a mandate that any patient receiving a non-surgical, cosmetic procedure must first be assessed and examined by the physician or, in the alternative, a midlevel practitioner acting under the delegation of the physician. The physician or midlevel practitioner is then responsible for establishing a diagnosis, obtaining the patient's informed consent, and preparing a treatment plan. Under the present law, a non-physician can arguably perform many of these functions as long as it is closely delineated by standing delegation orders and protocols developed by the physician.
The Texas Medical Board's proposed new rule also requires that either the physician or a midlevel practitioner be on-site during the performance of any delegated procedures. Additionally, the supervising physician is required to develop and maintain detailed protocols governing their delegates and must also create a quality assurance program satisfying various criteria. Importantly, the proposed rule makes clear the physician retains ultimate responsibility for the safety of the patient and the proper performance of the procedure.
Several exemptions are located in the rule: These include laser hair removal performed in accordance with the Texas Health and Safety Code, the use of nonprescription devices, surgery as defined in the Medical Practice Act, and procedures performed by midlevel practitioners at their supervising physician's primary practice site.
Although the rule has not yet been accepted by the Medical Board, I anticipate it will eventually be adopted. This has been a hot topic lately and it is clear the existing law is not satisfactory to both the Board's Members and Staff. Physicians and unlicensed individuals performing these types of procedures need to be aware of the new rule and poised to ensure they are in compliance when and if it is enacted.
The Texas Medical Board aggressively pursues perceived violations in this area and I would only expect this to increase should the rule be adopted. My firm recently represented a licensed cosmetologist who was issued a Cease and Desist Order by the Board based on their belief my client was practicing medicine in the course of providing Botox injections due to inadequate oversight by her supervising physician. Attorneys at the Leichter Law Firm filed an appeal against the Order and the Texas Medical Board agreed to rescind it based on inadequate notice to our client. Currently, the matter is expected to proceed to a new cease and desist hearing.
Physicians and their delegates concerned about remaining in compliance with both the current law and proposed new rule should feel free to contact the Leichter Law Firm at 512-495-9995. We have assisted several other clients in this area some of which faced active cases with the Texas Medical Board and others who only wanted to ensure their protocols and procedures passed muster.