Rule 540-X-11 “Guidelines for the Use of Lasers and Other Modalities Affecting Living Tissue” has been a rule in Alabama since 2007. However, on March 16, 2023, the Medical Board passed changes and additions to the Rule, which became effective on July 17, 2023. The deadline for compliance with the provisions is July 17, 2024.
Although the Medical Board made many changes, an important change to the rules is that these rules apply to many cosmetic lasers including cryotherapy, infrared lasers, radiofrequency micro-needling, Class III lasers that work on heat-based targeting of skin and collagen. The Medical Board made many changes to Rule 540-X-11. The Medical Board made many notable changes to the rule that may apply to med spa practitioners, including as follows:
- Adding registered nurses to the definition of “Level 1 Delegate.”
- Requiring compliance with the rules for “removing body art with LLBD” but not placing body art on the body.
- Adding “Continuing Education and Minimum Annual Procedures Required.”
- Specifying that a Level 2 Delegate is a “licensed practicing nurse (LPN) or medical assistant to include aestheticians, cosmetologists, and laser technicians.”
- Specifying that using lasers for cosmetic conditions constitutes “the practice of medicine.”
- Adding nine specific categories of procedures.
- Allowing a physician to delegate non-ablative treatments to Level 1 or 2 delegates with supervision.
- Adding initial educational and training requirements for physicians and delegates.
- Requiring specific procedure and device requirements for each type of procedure.
- Requiring physicians to register prior to performing any LLBD procedure with ongoing annual registration requirements.
- Requiring reporting of adverse events within three business days of the occurrence of the event.
- Adding continuing education and minimum annual procedure requirements.
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, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.
*Disclaimer: Thoughts shared here do not constitute legal advice.