SLS 20RS-311 ORIGINAL 2020 Regular Session SENATE BILL NO. 199 BY SENATOR MCMATH HEALTH CARE. Provides relative to physician practice standards in a medical spa. (8/1/20) 1 AN ACT 2 To enact R.S. 37:1293, relative to physician practice standards in a medical spa; to provide 3 for public purpose; to provide for definitions; to provide for minimum 4 responsibilities of the medical director of a medical spa; to provide for minimum 5 responsibilities of a supervising physician in a medical spa; to provide for minimum 6 responsibilities of a nonphysician provider in a medical spa; to provide for 7 rulemaking by the Louisiana State Board of Medical Examiners; to provide for 8 limitation of scope of practice for nonphysician providers; and to provide for related 9 matters. 10 Be it enacted by the Legislature of Louisiana: 11 Section 1. R.S. 37:1293 is hereby enacted to read as follows: 12 ยง1293. Physician practice standards; medical spa 13 A. The legislature hereby finds and declares that: 14 (1) Patients are increasingly seeking cosmetic medical procedures and 15 it is crucial that patient safety remains the top priority for providers of these 16 services. 17 (2) Cosmetic medical procedures are often done outside of a physician's Page 1 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 199 SLS 20RS-311 ORIGINAL 1 office and in a medical spa, many of which are legitimate, safe, physician-owned 2 facilities that operate with a high standard of patient care. 3 (3) The lack of physician regulations regarding medical spas have 4 enabled some medical spas to offer cosmetic medical procedures by 5 inadequately trained or unsupervised nonphysician providers to an 6 unsuspecting public. 7 (4) Some medical spas have a physician listed as a medical director, who 8 does not own the facility or is not onsite or immediately available to directly 9 supervise nonphysician providers. 10 (5) It is in the public's best interest to protect patients from harm by 11 ensuring that medical spas deliver safe medical care supervised by an on-site 12 physician. 13 B. For purposes of this Section, the following definitions shall apply: 14 (1) "Board" means the Louisiana State Board of Medical Examiners. 15 (2) "Cosmetic medical procedure" means medical procedures or 16 treatments that are performed to alter or reshape normal structures of the body 17 or ablate or remove living tissue solely in order to improve physical appearance. 18 (3) "Delegate" means tasking a nonphysician provider with performing 19 a cosmetic medical procedure at a medical spa by a physician. 20 (4) "Medical director" means a physician who assumes the role of, or 21 holds himself out as, medical director at a medical spa. 22 (5) "Medical spa" means a facility that provides cosmetic medical 23 procedures outside of a physician's office, which may include neuromodulators, 24 dermal fillers, and non-ablative laser procedures. 25 (6) "Patient" means a consumer or customer receiving services in a 26 medical spa. 27 (7) "Physician" has the same meaning as provided for in R.S. 37:1262(2). 28 (8) "Supervision" means direction provided by a supervising physician 29 that is both present onsite at the medical spa facility and immediately able to Page 2 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 199 SLS 20RS-311 ORIGINAL 1 respond in-person as needed. 2 C. The medical director of a medical spa shall be: 3 (1) Trained in the indications for and performance of cosmetic medical 4 procedures, including all medical devices or instruments that can alter or cause 5 biologic change or damage the skin and subcutaneous tissue. 6 (2) Responsible for implementing policies and procedures to ensure 7 quality patient care and for the delegation and supervision of cosmetic medical 8 procedures. 9 (3) Responsible for all cosmetic medical procedures performed by 10 physicians or nonphysician providers at a medical spa. 11 (4) Responsible for ensuring that all supervising physicians and 12 nonphysician providers who are delegated to perform cosmetic medical 13 procedures are properly trained in the safe and effective performance of all 14 cosmetic medical procedures performed at the medical spa. 15 D. At least one physician shall be designated as a supervising physician 16 at a medical spa. A supervising physician shall: 17 (1) Develop and maintain written office protocols for each cosmetic 18 medical procedure. 19 (2) Perform the initial assessment of the patient. 20 (3) Prepare a written treatment plan for each patient, including 21 diagnosis, course of treatment, and specifications for any device being utilized. 22 (4) Obtain patient consent if the procedure is being done by a 23 nonphysician provider. The supervising physician shall identify the credentials 24 and name of the nonphysician provider who will be performing the medical 25 procedure. 26 (5) Create and maintain medical records in a manner consistent with 27 accepted medical practice and in compliance with the rules promulgated by the 28 board. 29 E. Nonphysician providers may only perform cosmetic medical Page 3 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 199 SLS 20RS-311 ORIGINAL 1 procedures if they have been properly trained in performance of the procedure 2 and if the procedure has been delegated to them by a supervising physician. 3 Each nonphysician provider in a medical spa shall: 4 (1) Wear identification that clearly communicates he is not a physician, 5 identifies the type of provider he is and his licensing. 6 (2) Review and follow written protocols for each delegated cosmetic 7 medical procedure. 8 (3) Verify that a supervising physician has assessed the patient and given 9 written treatment instructions for each procedure to be performed. 10 (4) Review the cosmetic medical procedure to be performed with each 11 patient. 12 (5) Notify the medical director and supervising physician of any adverse 13 events or complications before the patient leaves the medical spa, or as they 14 become aware any adverse event or complication, and follow-up communication 15 with the patient post-operatively. 16 (6) Document all relevant details of the cosmetic medical procedure in 17 each patient's medical record. 18 (7) Satisfy any requirements imposed by the respective licensing board 19 of the nonphysician. 20 F. (1)The board shall promulgate rules and regulations to implement the 21 provisions of this Section, including the identification of approved continuing 22 medical education programs that satisfy the training requirement of this 23 Section. 24 (2) Training by a vendor or manufacturer of any injectable or medical 25 device used during a cosmetic medical procedure is insufficient as the 26 physician's only educational training and shall not satisfy the requirement of 27 this Section. 28 G. Nothing in this Section shall be construed to expand existing law or 29 regulation regarding the scope of practice of nonphysician providers. Page 4 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions. SB NO. 199 SLS 20RS-311 ORIGINAL 1 Section 2. This Act shall be known as and may be cited as the "Medical Spa Safety 2 Act". The original instrument and the following digest, which constitutes no part of the legislative instrument, were prepared by Christine Arbo Peck. DIGEST SB 199 Original 2020 Regular Session McMath Proposed law enacts the "Medical Spa Safety Act" and provides minimum physician practice standards for operation of a medical spa. Proposed law provides public purpose and definitions. Proposed law provides minimum requirements for the medical director of the medical spa including, certain training in cosmetic medical procedures and assuming responsibility for implementing policies and procedures, for all cosmetic medical procedures performed by nonphysician providers, and ensuring that all supervising physicians and nonphysician providers are properly trained. Proposed law provides minimum responsibilities for a supervising physician practicing in a medical spa including development of protocols for each cosmetic medical procedure, performing the initial assessment of the patient, preparing a written treatment plan for each patient, obtaining patient consent for treatment by a nonphysician provider, and creating and maintaining medical records. Proposed law provides that a nonphysician provider shall only perform cosmetic medical procedures if he has been properly trained. Proposed law provides that a nonphysician provider must wear identification indicating that he is not a physician and what provider license or type he has attained, review protocols, verify the assessment of the patient by a supervising physician, review the procedure with the patient, and notify the medical director or supervising physician if there are any complications with a procedure. Proposed law provides for rulemaking by the Louisiana State Board of Medical Examiners. Proposed law shall not be construed to expand the scope of practice of nonphysician providers. Effective August 1, 2020. (Adds R.S. 37:1293) Page 5 of 5 Coding: Words which are struck through are deletions from existing law; words in boldface type and underscored are additions.