Florida Senate - 2025 SB 424 By Senator Gaetz 1-01021B-25 2025424__ 1 A bill to be entitled 2 An act relating to office surgery standards of 3 practice; providing a short title; amending ss. 4 458.328 and 459.0138, F.S.; prohibiting physicians 5 from performing level II or level III surgeries on 6 immediate family members in an office surgery setting, 7 with exceptions; defining the term immediate family 8 member; prohibiting physicians from altering or 9 changing a consent form for a surgical procedure after 10 the patient has signed the form or after sedative 11 drugs have been administered to the patient; 12 specifying requirements for health care professionals 13 performing duties at a registered office which require 14 licensure or certification; specifying practice 15 standards for office surgeries; requiring office 16 surgeries to report adverse incidents to the 17 Department of Health within a specified timeframe; 18 specifying requirements if an adverse incident occurs 19 due to a local anesthetic; prohibiting office 20 surgeries from performing surgical procedures 21 concurrently with any construction or refurbishment 22 that interferes with the safe performance of such 23 procedures until it is safe to do so; requiring the 24 department to create an oversight committee for 25 specified purposes; requiring physicians performing 26 surgeries in office surgery settings to comply with 27 specified financial responsibility requirements; 28 providing an effective date. 29 30 Be It Enacted by the Legislature of the State of Florida: 31 32 Section 1.This act may be cited as Hillarys Law. 33 Section 2.Present subsection (3) of section 458.328, 34 Florida Statutes, is redesignated as subsection (4), a new 35 subsection (3) is added to that section, and subsection (2) is 36 amended, to read: 37 458.328Office surgeries. 38 (2)STANDARDS OF PRACTICE. 39 (a)A physician may not perform any surgery or procedure 40 identified in paragraph (1)(a) in a setting other than an office 41 surgery setting registered under this section or a facility 42 licensed under chapter 390 or chapter 395, as applicable. The 43 board shall impose a fine of $5,000 per incident on a physician 44 who violates this paragraph. 45 (b)Office surgeries may not: 46 1.Be a type of surgery that generally results in blood 47 loss of more than 10 percent of estimated blood volume in a 48 patient with a normal hemoglobin level; 49 2.Require major or prolonged intracranial, intrathoracic, 50 abdominal, or joint replacement procedures, except for 51 laparoscopic procedures; 52 3.Involve major blood vessels and be performed with direct 53 visualization by open exposure of the major blood vessel, except 54 for percutaneous endovascular intervention; or 55 4.Be emergent or life threatening. 56 (c)A physician performing a gluteal fat grafting procedure 57 in an office surgery setting shall adhere to standards of 58 practice under this subsection and rules adopted by the board 59 which include, but are not limited to, all of the following: 60 1.A physician performing a gluteal fat grafting procedure 61 must conduct an in-person examination of the patient while 62 physically present in the same room as the patient no later than 63 the day before the procedure. 64 2.Before a physician may delegate any duties during a 65 gluteal fat grafting procedure, the patient must provide 66 written, informed consent for such delegation. Any duty 67 delegated by a physician during a gluteal fat grafting procedure 68 must be performed under the direct supervision of the physician 69 performing such procedure. Fat extraction and gluteal fat 70 injections must be performed by the physician and may not be 71 delegated. 72 3.Fat may only be injected into the subcutaneous space of 73 the patient and may not cross the fascia overlying the gluteal 74 muscle. Intramuscular or submuscular fat injections are 75 prohibited. 76 4.When the physician performing a gluteal fat grafting 77 procedure injects fat into the subcutaneous space of the 78 patient, the physician must use ultrasound guidance, or guidance 79 with other technology authorized under board rule which equals 80 or exceeds the quality of ultrasound, during the placement and 81 navigation of the cannula to ensure that the fat is injected 82 into the subcutaneous space of the patient above the fascia 83 overlying the gluteal muscle. Such guidance with the use of 84 ultrasound or other technology is not required for other 85 portions of such procedure. 86 5.An office in which a physician performs gluteal fat 87 grafting procedures must at all times maintain a ratio of one 88 physician to one patient during all phases of the procedure, 89 beginning with the administration of anesthesia to the patient 90 and concluding with the extubation of the patient. After a 91 physician has commenced, and while he or she is engaged in, a 92 gluteal fat grafting procedure, the physician may not commence 93 or engage in another gluteal fat grafting procedure or any other 94 procedure with another patient at the same time. 95 (d)A physician may not: 96 1.Perform a level II or level III surgery on an immediate 97 family member unless the family member, due to cost or to 98 availability of alternate providers, cannot reasonably obtain 99 the surgical service from another physician. As used in this 100 subparagraph, the term immediate family member means a parent, 101 spouse, child, or sibling. 102 2.Alter or change an informed consent form for a procedure 103 after the consent has been signed, or after any sedative drugs 104 are administered to the patient. 105 (e)All health care professionals performing duties at a 106 registered office which require licensure or certification must 107 be: 108 1.Licensed or certified, and may not perform surgeries or 109 procedures outside the scope of his or her license or 110 certification. 111 2.Certified in advanced cardiac life support and maintain 112 certification through continuing education every 2 years. 113 (f)A registered office must have: 114 1.Appropriate staff on premises for procedures and 115 surgeries and administrative duties. 116 2.On the premises at all times a functioning automated 117 external defibrillator device as defined in s. 768.1325(2)(b) 118 and all necessary critical care equipment and medications. 119 3.Preoperative guidelines, intraoperative protocols, and 120 postoperative recovery guidelines in place for each surgery and 121 procedure, and any follow-up surgeries and procedures, for every 122 patient. 123 4.Qualified anesthesia personnel present in the room 124 throughout the administration of all general and regional 125 anesthetics and provision of monitored anesthesia care. 126 5.Proper protocols in place for storing, accessing, 127 administering, and dispensing sedatives and drugs listed in 128 Schedule II, Schedule III, or Schedule IV of s. 893.03. 129 (g)(d)If a procedure in an office surgery setting results 130 in hospitalization, the incident must be reported as an adverse 131 incident pursuant to s. 458.351 within 48 hours after its 132 occurrence. If an adverse incident occurs due to a local 133 anesthetic, all vials related to the local anesthetic and its 134 constitution that were administered must be saved as evidence 135 for the department and the sheriffs office or municipal police 136 department. 137 (h)A registered office having to undergo any type of 138 construction or refurbishment that materially interferes with 139 the safe performance of a surgical procedure in the office may 140 not perform any surgeries or procedures in the building until it 141 is safe to do so. 142 (i)An oversight committee shall be created by the 143 department that oversees any violations of this section and 144 reports such violations to the department. 145 (3)LIABILITY.Any physician performing office surgeries in 146 an office registered under this section must comply with the 147 financial responsibility requirements set forth in s. 458.320. 148 Section 3.Present subsection (3) of section 459.0138, 149 Florida Statutes, is redesignated as subsection (4), a new 150 subsection (3) is added to that section, and subsection (2) is 151 amended, to read: 152 459.0138Office surgeries. 153 (2)STANDARDS OF PRACTICE. 154 (a)A physician may not perform any surgery or procedure 155 identified in paragraph (1)(a) in a setting other than an office 156 surgery setting registered under this section or a facility 157 licensed under chapter 390 or chapter 395, as applicable. The 158 board shall impose a fine of $5,000 per incident on a physician 159 who violates this paragraph. 160 (b)Office surgeries may not: 161 1.Be a type of surgery that generally results in blood 162 loss of more than 10 percent of estimated blood volume in a 163 patient with a normal hemoglobin level; 164 2.Require major or prolonged intracranial, intrathoracic, 165 abdominal, or joint replacement procedures, except for 166 laparoscopic procedures; 167 3.Involve major blood vessels and be performed with direct 168 visualization by open exposure of the major blood vessel, except 169 for percutaneous endovascular intervention; or 170 4.Be emergent or life threatening. 171 (c)A physician performing a gluteal fat grafting procedure 172 in an office surgery setting shall adhere to standards of 173 practice under this subsection and rules adopted by the board 174 which include, but are not limited to, all of the following: 175 1.A physician performing a gluteal fat grafting procedure 176 must conduct an in-person examination of the patient while 177 physically present in the same room as the patient no later than 178 the day before the procedure. 179 2.Before a physician may delegate any duties during a 180 gluteal fat grafting procedure, the patient must provide 181 written, informed consent for such delegation. Any duty 182 delegated by a physician during a gluteal fat grafting procedure 183 must be performed under the direct supervision of the physician 184 performing such procedure. Fat extraction and gluteal fat 185 injections must be performed by the physician and may not be 186 delegated. 187 3.Fat may only be injected into the subcutaneous space of 188 the patient and may not cross the fascia overlying the gluteal 189 muscle. Intramuscular or submuscular fat injections are 190 prohibited. 191 4.When the physician performing a gluteal fat grafting 192 procedure injects fat into the subcutaneous space of the 193 patient, the physician must use ultrasound guidance, or guidance 194 with other technology authorized under board rule which equals 195 or exceeds the quality of ultrasound, during the placement and 196 navigation of the cannula to ensure that the fat is injected 197 into the subcutaneous space of the patient above the fascia 198 overlying the gluteal muscle. Such guidance with the use of 199 ultrasound or other technology is not required for other 200 portions of such procedure. 201 5.An office in which a physician performs gluteal fat 202 grafting procedures must at all times maintain a ratio of one 203 physician to one patient during all phases of the procedure, 204 beginning with the administration of anesthesia to the patient 205 and concluding with the extubation of the patient. After a 206 physician has commenced, and while he or she is engaged in, a 207 gluteal fat grafting procedure, the physician may not commence 208 or engage in another gluteal fat grafting procedure or any other 209 procedure with another patient at the same time. 210 (d)A physician may not: 211 1.Perform a level II or level III surgery on an immediate 212 family member unless the family member, due to cost or to 213 availability of alternate providers, cannot reasonably obtain 214 the surgical service from another physician. As used in this 215 subparagraph, the term immediate family member means a parent, 216 spouse, child, or sibling. 217 2.Alter or change an informed consent form for a procedure 218 after the consent has been signed, or after any sedative drugs 219 are administered to the patient. 220 (e)All health care professionals performing duties at a 221 registered office which require licensure or certification must 222 be: 223 1.Licensed or certified, and may not perform surgeries or 224 procedures outside the scope of his or her license or 225 certification. 226 2.Certified in advanced cardiac life support and maintain 227 certification through continuing education every 2 years. 228 (f)A registered office must have: 229 1.Appropriate staff on premises for procedures and 230 surgeries and administrative duties. 231 2.On the premises at all times a functioning automated 232 external defibrillator device as defined in s. 768.1325(2)(b) 233 and all necessary critical care equipment and medications. 234 3.Preoperative guidelines, intraoperative protocols, and 235 postoperative recovery guidelines in place for each surgery and 236 procedure, and any follow-up surgeries and procedures, for every 237 patient. 238 4.Qualified anesthesia personnel present in the room 239 throughout the administration of all general and regional 240 anesthetics and provision of monitored anesthesia care. 241 5.Proper protocols in place for storing, accessing, 242 administering, and dispensing sedatives and drugs listed in 243 Schedule II, Schedule III, or Schedule IV of s. 893.03. 244 (g)(d)If a procedure in an office surgery setting results 245 in hospitalization, the incident must be reported as an adverse 246 incident pursuant to s. 458.351 within 48 hours after its 247 occurrence. If an adverse incident occurs due to a local 248 anesthetic, all vials related to the local anesthetic and its 249 constitution that were administered must be saved as evidence 250 for the department and the sheriffs office or municipal police 251 department. 252 (h)A registered office having to undergo any type of 253 construction or refurbishment that materially interferes with 254 the safe performance of a surgical procedure in the office may 255 not perform any surgeries or procedures in the building until it 256 is safe to do so. 257 (i)An oversight committee shall be created by the 258 department that oversees any violations of this section and 259 reports such violations to the department. 260 (3)LIABILITY.Any physician performing office surgeries in 261 an office registered under this section must comply with the 262 financial responsibility requirements set forth in s. 459.0085. 263 Section 4.This act shall take effect July 1, 2025.