SB 226: Regards use of light-based medical devices for hair removal

As Introduced

136th General Assembly

Regular Session

Senator Gavarone

To amend section 4731.33 and to enact section 1 4731.331 of the Revised Code regarding the 2 application of light-based medical devices for 3 the purpose of hair removal.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Section 1. That section 4731.33 be amended and section 5 4731.331 of the Revised Code be enacted to read as follows:

Sec. 4731.33.

(A) As used in this section and section 7 4731.331 of the Revised Code:

1. 9 "Laser hair removal professional" means an individual 10 who applies a light-based medical device to a patient for the 11 purpose of hair removal and who meets either of the criteria 12 described in division (B) (3) (b) of this section.
2. 13 "Light-based medical device" means any device that can 14 be made to produce or amplify electromagnetic radiation at 15 wavelengths equal to or greater than one hundred eighty nm but 16 less than or equal to $1.0-\mathrm{X}-106$-one thousand sixty-four nm and 17 that is manufactured, designed, intended, or promoted for 18 irradiation of any part of the human body for the purpose of 19 affecting the structure or function of the body.
3. 21 "Nurse" means a registered nurse or licensed practical 22 nurse, each as defined in section 4723.01 of the Revised Code. A 23 "nurse" does not include a registered nurse who is also an 24 advanced practice registered nurse, as defined in section 25 4723.01 of the Revised Code.
4. 25 "Physician" means a-person-an individual authorized 26 to practice medicine and surgery, osteopathic medicine and 27 surgery, or podiatric medicine and surgery under this chapter.
5. 28 "On-site supervision" means the supervising 29 physician is physically in the same location as the delegate 30 during the use of a light-based medical device, but does not 31 require the physician to be in the same room. "On-site 32 supervision" includes the supervising physician's presence in 33 the same office suite as the delegate during the use of the 34 device.
6. 35 "Off-site supervision" means the supervising 36 physician is continuously available for direct communication 37 with the cosmetic-therapist-delegate during the use of a light- 38 based medical device.
7. 39 "Direct physical oversight" means the supervising 40 physician is in the same room directly observing the delegate's 41 use of the light-based medical device.

(B) A physician may delegate the application of light- 42 based medical devices for the purpose of hair removal only if 43 all of the following conditions are met:

1. 45 The light-based medical device has been specifically 46 cleared or approved by the United States food and drug 47 administration for the removal of hair from the human body.
2. 48 The use of the light-based medical device for the 49 purpose of hair removal is within the physician's normal course 50 of practice and expertise.
3. 51 The-physician-has-seen-and-evaluated-the-patient-to- 52 determine-whether-the-proposed-application-of-the-specifie- 53 light-based-medical-device-is-appropriate.
4. 54 The-physician-has-seen-and-evaluated-the-patient- 55 following-the-initial-application-of-the-specific-light-based- 56 medical-device, but-before-any-continuation-of-treatment, to- 57 determine-that-the-patient-responded-well-to-that-initial- 58 application-of-the-specific-light-based-medical-device.
5. 59 The person-to-whom-the-delegation-is-made-delegate-is one of the following:

1. 62 A physician assistant licensed under Chapter 4730. of the Revised Code with whom the physician has an effective 63 supervision agreement;
2. 66 A person-laser hair removal professional who is either of the following:

1. 67 An individual who was-licensed-held a license as a 68 cosmetic therapist under Chapter 4731. of the Revised Code on 69 April 11, 2021;
2. 70 An individual who has completed a 71 cosmetic therapy course of instruction for a minimum of seven 72 hundred fifty clock hours and received a passing score on the 73 certified laser hair removal professional examination 74 administered by the society for clinical and medical hair 75 removal;

1. 75 A-registered-nurse-or-licensed-practical-nurse- 76 licensed-under-Chapter-4723.-of-the-Revised-Code.

(C) For delegation to a physician assistant, the 78 delegation must meet the requirements of section 4730.21 of the 79 Revised Code.

(D) (1) (D) For delegation to a person-described-under- 80 division (B) (5) (b) or (c) of this sectionlaser hair removal 81 professional, all of the following criteria must be met:

1. 83 The delegating physician shall ensure that the person- 84 to whom the delegation is made laser hair removal professional 85 has received adequate education and training to provide the 86 level of skill and care necessary, including all of the 87 following:

1. 88 The person-laser hair removal professional has 89 completed eight hours of basic education that includes the 90 following topics:

1. 91 Light-based procedure physics;
2. 92 Tissue interaction in light-based procedures;
3. 93 Light-based procedure safety, including use of 94 proper safety equipment;
4. 95 Clinical application of light-based procedures;
5. 96 Preoperative and postoperative care of light-based 97 procedure patients;
6. 98 Reporting of adverse events.

1. 99 The person-laser hair removal professional has 100 observed fifteen procedures for each specific type of light- 101 based medical device procedure for hair removal that the person- 102 laser hair removal professional will perform under the 103 delegation. For purposes of this division, the procedures 104 observed shall be performed by a physician who uses the specific 105 light-based medical device procedure for hair removal in the physician's normal course of practice and expertise.
2. 106 The person-laser hair removal professional shall perform has performed at least twenty procedures under the direct physical oversight of the physician on each specific type of light-based medical device procedure for hair removal delegated. For purposes of this division, the physician overseeing the performance of these procedures shall use this specific light-based medical device procedure for hair removal within the physician's normal course of practice and expertise.

1. 109 For-purposes-of-division-(D)-(1)-(b)-of-this-section, the-procedures-observed-shall-be-performed-by-a-physician-who uses-the-specific-light-based-medical-device-procedure-for-hair-removal-in-the-physician's-normal-course-of-practice-and-expertise. The delegating physician shall see and evaluate the patient before the use of the light-based medical device on the patient to determine whether the proposed application of the specific light-based medical device is appropriate.
2. 114 For-purposes-of-division-(D)-(1)-(c)-of-this-section, the-physician-overseeing-the-performance-of-these-procedures shall-use-this-specific-light-based-medical-device-procedure-for hair-removal-within-the-physician's-normal-course-of-practice and-expertise. The delegating physician shall see and evaluate the patient following the initial application of the specific light-based medical device, but before any continuation of treatment, to determine that the patient responded well to that initial application of the specific light-based medical device.
3. 120 Each delegating physician and delegate-laser hair removal professional shall document and retain satisfactory completion of training required under division (D) of this section. The education requirement in division (D) (1) (a) of this section shall be completed only once by the delegate-laser hair removal professional regardless of the number of types of specific light-based medical device procedures for hair removal delegated and the number of delegating physicians. The training requirements of divisions (D) (1) (b) and (c) of this section shall be completed by the delegate-laser hair removal professional once for each specific type of light-based medical device procedure for hair removal delegated regardless of the number of delegating physicians.

(E) The following delegates-laser hair removal 126 professionals are exempt from the education and training 127 requirements of division (D) (1) of this section:

1. 129 A-person-An individual who, before the effective date- 130 of this section-September 30, 2021, has been applying a light- 131 based medical device for hair removal for at least two years 132 through a lawful delegation by a physician;
2. 133 A-person-An individual described under division (B) (5) 134 (b) (B) (3) (b) (i) of this section if the person-individual was 135 authorized to use a light-based medical device under the 136 cosmetic therapist license;
3. 137 A person described in division (B) (5) (a) or (d) of this section.

(F) (F) (1) For delegation to a person under division (B) (5) 139 (b), (c), or (d) of this section laser hair removal professional, 140 the delegating physician shall provide on-site supervision at 141 all times that the person to whom the delegation is made laser 142 hair removal professional is applying the light-based medical 143 device.

A-physician-shall-not-supervise-more-than-two-delegates- 144 under-division-(B)-(5)-(b),-(c), or-(d)-of-this-section-at-the- 145 same-time.

(G)-(1)-(2) Notwithstanding division (F)-(F)-(1) of this 147 section, a delegating physician may provide off-site supervision 148 of a laser hair removal professional when the light-based 149 medical device is applied for the purpose of hair removal to an 150 established patient if the person-to-whom-the-delegation-is-made 151 is-a-cosmetic-therapist-who-laser hair removal professional 152 meets all-of-each of the following criteria:

1. 154 The cosmetic-therapist-laser hair removal professional 155 has successfully completed a course in the use of light-based 156 medical devices for the purpose of hair removal that has been 157 approved by the delegating physician:
2. 158 The- and the course consisted of at least fifty hours 159 of training, at least thirty hours of which was clinical 160 experience;
3. 161 The cosmetic-therapist-laser hair removal 162 professional has worked under the on-site supervision of the 163 delegating physician for a sufficient period of time that the 164 physician is satisfied that the cosmetic-therapist-laser hair 165 removal professional is capable of competently performing the 166 service with off-site supervision.

(2)-The cosmetic-therapist-laser hair removal professional 168 shall maintain documentation of the successful completion of the 169 required training.

(3) When providing supervision under division (F) (1) or 171 (2) of this section, a physician shall supervise not more than 172 five laser hair removal professionals at the same time.

(H) (G) (1) For delegation to a nurse, the delegating 173 physician shall provide on-site supervision at all times that 174 the nurse is applying the light-based medical device.

(2) Notwithstanding division (G) (1) of this section, a physician may provide off-site supervision of a nurse applying a 177 light-based medical device to a patient for the purpose of hair 178 removal if the nurse has completed a training and education 179 program on the use of light-based medical devices for the 180 purpose of hair removal that has been approved by the delegating 181 physician. An approved training and education program shall 182 satisfy both of the following criteria:

1. 184 The program may be completed internally at the laser 185 hair removal facility or externally through a third-party 186 provider, provided the third-party program is overseen by a 187 physician.
2. 188 The program includes forty total hours of training, 189 which may be a combination of didactic training, in-person 190 hands-on training, and performance of laser hair removal 191 procedures.

The nurse shall maintain documentation of the successful 193 completion of the required training.

(3) When providing supervision under division (G) (1) or 195 (2) of this section, the physician shall supervise not more than 196 five nurses at the same time.

(H) A delegate under this section shall immediately report 198 to the supervising physician any clinically significant side 199 effect following the application of the light-based medical 200 device or any failure of the treatment to progress as was 201 expected at the time the delegation was made. The physician 202 shall see and personally evaluate the patient who has 203 experienced the clinically significant side effect or whose 204 treatment is not progressing as expected as soon as practicable.

(I) No physician shall fail to comply with division (A), 206 (B), (F), (G), or (H) of this section. A violation of this 207 division constitutes a departure from, or the failure to conform 208 to, minimal standards of care of similar practitioners under the 209 same or similar circumstances, whether or not actual injury to a 210 patient is established, under division (B) (6) of section 4731.22 211 of the Revised Code.

(J) No physician shall delegate the application of light- 213 based medical devices for the purpose of hair removal to aperson an individual who is not listed in division (B) (5) (B) (3) 215 of this section. A violation of this division constitutes 216 violating or attempting to violate, directly or indirectly, or 217 assisting in or abetting the violation of, or conspiring to 218 violate section 4731.41 of the Revised Code for purposes of 219 division (B) (20) of section 4731.22 of the Revised Code.

(K) No cosmetic therapist to whom a delegation is made- 221 under division (B) (5) (b) or (c) of this section laser hair 222 removal professional shall fail to comply with division (G) (F) 223 or (H) of this section. A violation of this division constitutes 224 the unauthorized practice of medicine pursuant to section 225 4731.41 of the Revised Code.

(L) No nurse shall fail to comply with division (G) or (H) 227 of this section. A violation of this division constitutes a 228 failure to practice in accordance with acceptable and prevailing 229 standards of safe nursing care, regardless of whether actual 230 injury to a patient is established, for purposes of division (B) 231 (19) of section 4723.28 of the Revised Code.

S. B. No. 226 Page 10
As Introduced

(M) No physician assistant shall fail to comply with 233 division (H) of this section. A violation of this division 234 constitutes a departure from, or failure to conform to, minimal 235 standards of care of similar physician assistants under the same 236 or similar circumstances, regardless of whether actual injury to 237 patient is established, for purposes of division (B) (19) of 238 section 4730.25 of the Revised Code.

Sec. 4731.331.

(A) As used in this section, "standard care 240 arrangement" has the same meaning as in section 4723.01 of the 241 Revised Code.

(B) With respect to a light-based medical device applied 243 to a patient for the purpose of hair removal, an advanced 244 practice registered nurse or physician assistant may do both of 245 the following:

1. 247 Delegate to a nurse or laser hair removal professional 248 the application of the light-based medical device to the 249 patient:
2. 251 Supervise the nurse's or laser hair removal 252 professional's application of the light-based medical device to 253 the patient.

(C) (1) An advanced practice registered nurse may take the 255 actions described in division (B) of this section only if the 256 actions are not prohibited by the advanced practice registered 257 nurse's standard care arrangement.

(2) A physician assistant may take the actions described 259 in division (B) of this section only if the physician assistant 260 satisfies the requirements of divisions (B) (3) (a) and (D) of 261 section 4731.33 of the Revised Code.

(3) In delegating to and supervising a nurse or laser hair 263 removal professional under this section, an advanced practice 264 registered nurse and physician assistant shall act in the same 265 manner and be subject to the same conditions and requirements as 266 a physician under section 4731.33 of the Revised Code.

(D) To be eligible to apply a light-based medical device 268 under this section, a nurse or laser hair removal professional 269 shall satisfy the same criteria for delegation and supervision 270 described in section 4731.33 of the Revised Code.

Section 2. That existing section 4731.33 of the Revised 272 Code is hereby repealed.