Our healthcare and business law firm works with healthcare providers and businesses to open cosmetic medical and wellness spas. The medical spa entity has grown drastically over the past few years. Some states and medical boards have developed laws and rules governing medical and wellness spas. As medical and wellness spas continue to grow, we can anticipate more laws and rules governing medical and wellness spas. On July 19, 2023, the Alabama Board of Medical Examiners (“Medical Board”) published changes to the rules governing the “Use of Lasers and Other Modalities,” which can be found in Chapter 540-X-11 of the Rules of the Medical Board. The rule is broken down into many different categories. A previous post provided an overview of the rule changes that are potentially applicable to medical spa practitioners. This post focuses on important rules that apply to Non-Laser Skin Rejuvenation procedures. If you have a question about the Alabama Medical Board’s rules or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, firstname.lastname@example.org. You may also learn more about our law firm by visiting www.hamillittle.com.
As mentioned in the previous blog post, the use of Lasers/Pulsed Light Devices (“LLBDs”) for cosmetic purposes is considered “the practice of medicine” in Alabama. Level 1 and Level 2 Delegates can perform certain LLBDs only if allowed by the rules, which go fully into effect on July 17, 2024. This post focuses on the new rules governing Non-Laser Skin Rejuvenation.
- Definition of Non-Laser Skin Rejuvenation
Non-Laser Skin Rejuvenation is defined as: “These procedures use energy sources such as radiofrequency, ultrasound, infrared, and Class III lasers that work on heat-based targeting of skin and collagen. These procedures include any ultrasonic treatments, treatments for skin tightening/fat removal (including cryolipolysis and cryotherapy), and radiofrequency micro-needling.”
A physician can delegate the performance of Non-Laser Skin Rejuvenation to Level 1 and 2 Delegates. A Level 1 Delegate is a physician assistant (PA), certified registered nurse practitioner (NP), and registered nurse (RN). A Level 2 Delegate is “a licensed practicing nurse (LPN) or medical assistant to include aestheticians, cosmetologists, and laser technicians authorized in a written job description or protocol to use a specific LLBD for non-ablative procedures.” Importantly, only Level 1 Delegates can perform Non-Laser Skin Rejuvenation with “locally remote supervision.”
- Locally Remote Supervision
“Locally remote supervision means the geographical physical proximity of a delegating physician to a Level 1 Delegate who is performing a non-ablative procedure who is not providing on-site supervision but who is readily available for consultation, evaluation, referral, or direct medical intervention in person or by telemedicine.” There are very strict requirements for locally remote supervision. Specifically, the “physician’s geographic physical proximity from the patient’s treatment site must not exceed the usual and customary response time of emergency management services for the locality,” and it “may only be provided by [board certified] physicians who have completed post-graduate training in lasers, light-based devices, chemical peels, and any other modality that may be used to perform ablative treatment.”
- Delegate Training
After the initial training requirements, the delegate must observe 5 area-specific treatments by a trained physician, 10 procedures under the direct supervision of a trained physician, and 10 additional treatments without direct supervision (provided the physician reviews the treatment plan and device settings prior to the treatment). “After completing ten treatments under direct supervision, a Level 1 or 2 Delegate may complete ten additional treatments without direct supervision by the physician, provided that the physician reviews the treatment plan and device settings prior to the treatment. After performing twenty-five supervised cases, a Level 1 or 2 Delegate may consult, consent, and treat patients without direct supervision by the physician. Thereafter, treatments may be performed under locally remote supervision,” but keep in mind that that is only available for Level 1 Delegates.
- Patient Examination for Level 1 Delegates
Even though Level 1 Delegates can perform treatments with locally remote supervision, the physician must still “examine the patient, establish a treatment plan, perform informed consent of the patient, and sign the patient chart prior to a Level 1 Delegate performing the first non-ablative treatment of a patient for a particular disease or condition at a remote practice site.” The Level 1 Delegate can perform subsequent treatments without the requirement of a physician exam unless the treatment plan changes or ends. ALBME Admin. Code, Section 540-X-11-.08(3). “The physician must re-examine the patient prior to any updated treatment being performed.” Id. It appears that a physician providing Locally Remote Supervision can perform patient evaluations through telemedicine, assuming compliance with other telemedicine rules.
If you have a question about the Alabama Medical Board’s rules or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, email@example.com. You may also learn more about our law firm by visiting www.hamillittle.com.
*Disclaimer: Thoughts shared here do not constitute legal advice.