Florida Senate - 2024 CS for SB 1188 By the Committee on Health Policy; and Senator Garcia 588-02981-24 20241188c1 1 A bill to be entitled 2 An act relating to office surgeries; amending ss. 3 458.328 and 459.0138, F.S.; revising the types of 4 procedures for which a medical office must register 5 with the Department of Health to perform office 6 surgeries; specifying notification and inspection 7 procedures for the department and the Agency for 8 Health Care Administration if, during the registration 9 process, the department determines that the 10 performance of specified procedures in the office 11 would create a risk to patient safety such that the 12 office should instead be regulated as an ambulatory 13 surgical center; deleting obsolete language; making 14 technical and clarifying changes; revising standards 15 of practice for office surgeries; requiring medical 16 offices already registered with the department to 17 perform certain office surgeries as of a specified 18 date to reregister if such offices perform specified 19 procedures; specifying notification and inspection 20 procedures for the department and the agency in the 21 event that, during the reregistration process, the 22 department determines that the performance of 23 specified procedures in an office creates a risk of 24 patient safety such that the office should instead be 25 regulated as an ambulatory surgical center; requiring 26 an office to cease performing the specified procedures 27 and relinquish its office surgery registration and 28 instead seek licensure as an ambulatory surgical 29 center under such circumstances; requiring the 30 department to develop a schedule for reregistration of 31 medical offices affected by this act, to be completed 32 by a specified date; providing an effective date. 33 34 Be It Enacted by the Legislature of the State of Florida: 35 36 Section 1.Paragraphs (a), (b), and (h) of subsection (1) 37 and subsection (2) of section 458.328, Florida Statutes, are 38 amended, and subsection (4) is added to that section, to read: 39 458.328Office surgeries. 40 (1)REGISTRATION. 41 (a)1.An office in which a physician performs a liposuction 42 procedure in which more than 1,000 cubic centimeters of 43 supernatant fat is temporarily or permanently removed, a 44 liposuction procedure in which the patient is rotated 180 45 degrees or more during the procedure, a gluteal fat grafting 46 procedure, a Level II office surgery, or a Level III office 47 surgery must register with the department. unless the office is 48 licensed as A facility licensed under chapter 390 or chapter 395 49 may not be registered under this section. 50 2.The department must complete an inspection of any office 51 seeking registration under this section before the office may be 52 registered. 53 3.If the department determines that an office seeking 54 registration under this section is one in which a physician is 55 likely to perform, or intends to perform, liposuction procedures 56 that include a patient being rotated 180 degrees or more during 57 the procedure or in which a physician is likely to perform, or 58 intends to perform, gluteal fat grafting procedures, and the 59 department determines that the performance of such procedures in 60 the office would create a significant risk to patient safety and 61 the interests of patient safety would be better served if such 62 procedures were instead regulated under the requirements of 63 ambulatory surgical center licensure under chapter 395: 64 a.The department must notify the Agency for Health Care 65 Administration of its determination. 66 b.The agency must inspect the office and determine, in the 67 interest of patient safety, whether the office is a candidate 68 for ambulatory surgical center licensure, notwithstanding the 69 offices failure to meet all requirements associated with such 70 licensure at the time of inspection and notwithstanding any 71 pertinent exceptions provided under s. 395.002(3). 72 c.If the agency determines that an office is a candidate 73 for ambulatory surgical center licensure under sub-subparagraph 74 b., the agency must notify the office and the department, and 75 the office may not register under this section and must instead 76 attain ambulatory surgical center licensure under chapter 395 77 before such surgeries may be conducted in the office. 78 d.If the agency determines that an office is not a 79 candidate for ambulatory surgical center licensure under sub 80 subparagraph b., the agency must notify the office and the 81 department, and the department shall resume the offices 82 registration process. 83 (b)By January 1, 2020, Each office registered under this 84 section or s. 459.0138 must designate a physician who is 85 responsible for the offices compliance with the office health 86 and safety requirements of this section and rules adopted 87 hereunder. A designated physician must have a full, active, and 88 unencumbered license under this chapter or chapter 459 and shall 89 practice at the office for which he or she has assumed 90 responsibility. Within 10 calendar days after the termination of 91 a designated physician relationship, the office must notify the 92 department of the designation of another physician to serve as 93 the designated physician. The department may suspend the 94 registration of an office if the office fails to comply with the 95 requirements of this paragraph. 96 (h)A physician may only perform a procedure or surgery 97 identified in paragraph (a) in an office that is registered with 98 the department. The board shall impose a fine of $5,000 per day 99 on a physician who performs a procedure or surgery in an office 100 that is not registered with the department. 101 (2)STANDARDS OF PRACTICE. 102 (a)A physician may not perform any surgery or procedure 103 identified in paragraph (1)(a) in a setting other than an office 104 registered under this section or a facility licensed under 105 chapter 390 or chapter 395, as applicable. The board shall 106 impose a fine of $5,000 per incident on a physician who violates 107 this paragraph performing a gluteal fat grafting procedure in an 108 office surgery setting shall adhere to standards of practice 109 pursuant to this subsection and rules adopted by the board. 110 (b)Office surgeries may not: 111 1.Be a type of surgery that generally results in blood 112 loss of more than 10 percent of estimated blood volume in a 113 patient with a normal hemoglobin level; 114 2.Require major or prolonged intracranial, intrathoracic, 115 abdominal, or joint replacement procedures, except for 116 laparoscopic procedures; 117 3.Involve major blood vessels and be performed with direct 118 visualization by open exposure of the major blood vessel, except 119 for percutaneous endovascular intervention; or 120 4.Be emergent or life threatening. 121 (c)A physician performing a gluteal fat grafting procedure 122 in an office surgery setting shall adhere to standards of 123 practice under this subsection and rules adopted by the board, 124 which include, but are not limited to, all of the following: 125 1.A physician performing a gluteal fat grafting procedure 126 must conduct an in-person examination of the patient while 127 physically present in the same room as the patient no later than 128 the day before the procedure. 129 2.Before a physician may delegate any duties during a 130 gluteal fat grafting procedure, the patient must provide 131 written, informed consent for such delegation. Any duty 132 delegated by a physician during a gluteal fat grafting procedure 133 must be performed under the direct supervision of the physician 134 performing such procedure. Fat extraction and gluteal fat 135 injections must be performed by the physician and may not be 136 delegated. 137 3.Fat may only be injected into the subcutaneous space of 138 the patient and may not cross the fascia overlying the gluteal 139 muscle. Intramuscular or submuscular fat injections are 140 prohibited. 141 4.When the physician performing a gluteal fat grafting 142 procedure injects fat into the subcutaneous space of the 143 patient, the physician must use ultrasound guidance, or guidance 144 with other technology authorized under board rule which equals 145 or exceeds the quality of ultrasound, during the placement and 146 navigation of the cannula to ensure that the fat is injected 147 into the subcutaneous space of the patient above the fascia 148 overlying the gluteal muscle. Such guidance with the use of 149 ultrasound or other technology is not required for other 150 portions of such procedure. 151 5.An office in which a physician performs gluteal fat 152 grafting procedures must at all times maintain a ratio of one 153 physician to one patient during all phases of the procedure, 154 beginning with the administration of anesthesia to the patient 155 and concluding with the extubation of the patient. After a 156 physician has commenced, and while he or she is engaged in, a 157 gluteal fat grafting procedure, the physician may not commence 158 or engage in another gluteal fat grafting procedure or any other 159 procedure with another patient at the same time. 160 (d)If a procedure in an office surgery setting results in 161 hospitalization, the incident must be reported as an adverse 162 incident pursuant to s. 458.351. 163 (e)An office in which a physician performs gluteal fat 164 grafting procedures must at all times maintain a ratio of one 165 physician to one patient during all phases of the procedure, 166 beginning with the administration of anesthesia to the patient 167 and concluding with the extubation of the patient. After a 168 physician has commenced, and while he or she is engaged in, a 169 gluteal fat grafting procedure, the physician may not commence 170 or engage in another gluteal fat grafting procedure or any other 171 procedure with another patient at the same time. 172 (4)REREGISTRATION.An office that registered under this 173 section before July 1, 2024, in which a physician performs 174 liposuction procedures that include a patient being rotated 180 175 degrees or more during the procedure or in which a physician 176 performs gluteal fat grafting procedures must seek 177 reregistration with the department consistent with the 178 parameters of initial registration under subsection (1) 179 according to a schedule developed by the department. During the 180 reregistration process, if the department determines that the 181 performance of such procedures in the office creates a 182 significant risk to patient safety and that the interests of 183 patient safety would be better served if such procedures were 184 instead regulated under the requirements of ambulatory surgical 185 center licensure under chapter 395: 186 (a)The department must notify the Agency for Health Care 187 Administration of its determination; and 188 (b)The agency must inspect the office and determine, in 189 the interest of patient safety, whether the office is a 190 candidate for ambulatory surgical center licensure, 191 notwithstanding the offices failure to meet all requirements 192 associated with such licensure at the time of inspection and 193 notwithstanding any pertinent exceptions provided under s. 194 395.002(3). 195 196 If the agency determines that an office is a candidate for 197 ambulatory surgical center licensure under paragraph (b), the 198 agency must notify the office and the department, and the office 199 must cease performing procedures described in this subsection. 200 The office may not recommence performing such procedures without 201 first relinquishing its registration under this section and 202 attaining ambulatory surgical center licensure under chapter 203 395. 204 Section 2.Paragraphs (a), (b), and (h) of subsection (1) 205 and subsection (2) of section 459.0138, Florida Statutes, are 206 amended, and subsection (4) is added to that section, to read: 207 459.0138Office surgeries. 208 (1)REGISTRATION. 209 (a)1.An office in which a physician performs a liposuction 210 procedure in which more than 1,000 cubic centimeters of 211 supernatant fat is temporarily or permanently removed, a 212 liposuction procedure in which the patient is rotated 180 213 degrees or more during the procedure, a gluteal fat grafting 214 procedure, a Level II office surgery, or a Level III office 215 surgery must register with the department. unless the office is 216 licensed as A facility licensed under chapter 390 or chapter 395 217 may not be registered under this section. 218 2.The department must complete an inspection of any office 219 seeking registration under this section before the office may be 220 registered. 221 3.If the department determines that an office seeking 222 registration under this section is one in which a physician is 223 likely to perform, or intends to perform, liposuction procedures 224 that include a patient being rotated 180 degrees or more during 225 the procedure or in which a physician is likely to perform, or 226 intends to perform, gluteal fat grafting procedures, and the 227 department determines that the performance of such procedures in 228 the office would create a significant risk to patient safety and 229 the interests of patient safety would be better served if such 230 procedures were instead regulated under the requirements of 231 ambulatory surgical center licensure under chapter 395: 232 a.The department must notify the Agency for Health Care 233 Administration of its determination. 234 b.The agency must inspect the office and determine, in the 235 interest of patient safety, whether the office is a candidate 236 for ambulatory surgical center licensure, notwithstanding the 237 offices failure to meet all requirements associated with such 238 licensure at the time of inspection and notwithstanding any 239 pertinent exceptions provided under s. 395.002(3). 240 c.If the agency determines that an office is a candidate 241 for ambulatory surgical center licensure under sub-subparagraph 242 b., the agency must notify the office and the department, and 243 the office may not register under this section and must instead 244 attain ambulatory surgical center licensure under chapter 395 245 before such surgeries may be conducted in the office. 246 d.If the agency determines that an office is not a 247 candidate for ambulatory surgical center licensure under sub 248 subparagraph b., the agency must notify the office and the 249 department, and the department shall resume the offices 250 registration process. 251 (b)By January 1, 2020, Each office registered under this 252 section or s. 458.328 must designate a physician who is 253 responsible for the offices compliance with the office health 254 and safety requirements of this section and rules adopted 255 hereunder. A designated physician must have a full, active, and 256 unencumbered license under this chapter or chapter 458 and shall 257 practice at the office for which he or she has assumed 258 responsibility. Within 10 calendar days after the termination of 259 a designated physician relationship, the office must notify the 260 department of the designation of another physician to serve as 261 the designated physician. The department may suspend a 262 registration for an office if the office fails to comply with 263 the requirements of this paragraph. 264 (h)A physician may only perform a procedure or surgery 265 identified in paragraph (a) in an office that is registered with 266 the department. The board shall impose a fine of $5,000 per day 267 on a physician who performs a procedure or surgery in an office 268 that is not registered with the department. 269 (2)STANDARDS OF PRACTICE. 270 (a)A physician may not perform any surgery or procedure 271 identified in paragraph (1)(a) in a setting other than an office 272 registered under this section or a facility licensed under 273 chapter 390 or chapter 395, as applicable. The board shall 274 impose a fine of $5,000 per incident on a physician who violates 275 this paragraph performing a gluteal fat grafting procedure in an 276 office surgery setting shall adhere to standards of practice 277 pursuant to this subsection and rules adopted by the board. 278 (b)Office surgeries may not: 279 1.Be a type of surgery that generally results in blood 280 loss of more than 10 percent of estimated blood volume in a 281 patient with a normal hemoglobin level; 282 2.Require major or prolonged intracranial, intrathoracic, 283 abdominal, or joint replacement procedures, except for 284 laparoscopic procedures; 285 3.Involve major blood vessels and be performed with direct 286 visualization by open exposure of the major blood vessel, except 287 for percutaneous endovascular intervention; or 288 4.Be emergent or life threatening. 289 (c)A physician performing a gluteal fat grafting procedure 290 in an office surgery setting shall adhere to standards of 291 practice under this subsection and rules adopted by the board, 292 which include, but are not limited to, all of the following: 293 1.A physician performing a gluteal fat grafting procedure 294 must conduct an in-person examination of the patient while 295 physically present in the same room as the patient no later than 296 the day before the procedure. 297 2.Before a physician may delegate any duties during a 298 gluteal fat grafting procedure, the patient must provide 299 written, informed consent for such delegation. Any duty 300 delegated by a physician during a gluteal fat grafting procedure 301 must be performed under the direct supervision of the physician 302 performing such procedure. Fat extraction and gluteal fat 303 injections must be performed by the physician and may not be 304 delegated. 305 3.Fat may only be injected into the subcutaneous space of 306 the patient and may not cross the fascia overlying the gluteal 307 muscle. Intramuscular or submuscular fat injections are 308 prohibited. 309 4.When the physician performing a gluteal fat grafting 310 procedure injects fat into the subcutaneous space of the 311 patient, the physician must use ultrasound guidance, or guidance 312 with other technology authorized under board rule which equals 313 or exceeds the quality of ultrasound, during the placement and 314 navigation of the cannula to ensure that the fat is injected 315 into the subcutaneous space of the patient above the fascia 316 overlying the gluteal muscle. Such guidance with the use of 317 ultrasound or other technology is not required for other 318 portions of such procedure. 319 5.An office in which a physician performs gluteal fat 320 grafting procedures must at all times maintain a ratio of one 321 physician to one patient during all phases of the procedure, 322 beginning with the administration of anesthesia to the patient 323 and concluding with the extubation of the patient. After a 324 physician has commenced, and while he or she is engaged in, a 325 gluteal fat grafting procedure, the physician may not commence 326 or engage in another gluteal fat grafting procedure or any other 327 procedure with another patient at the same time. 328 (d)If a procedure in an office surgery setting results in 329 hospitalization, the incident must be reported as an adverse 330 incident pursuant to s. 458.351. 331 (e)An office in which a physician performs gluteal fat 332 grafting procedures must at all times maintain a ratio of one 333 physician to one patient during all phases of the procedure, 334 beginning with the administration of anesthesia to the patient 335 and concluding with the extubation of the patient. After a 336 physician has commenced, and while he or she is engaged in, a 337 gluteal fat grafting procedure, the physician may not commence 338 or engage in another gluteal fat grafting procedure or any other 339 procedure with another patient at the same time. 340 (4)REREGISTRATION.An office that registered under this 341 section before July 1, 2024, in which a physician performs 342 liposuction procedures that include a patient being rotated 180 343 degrees or more during the procedure or in which a physician 344 performs gluteal fat grafting procedures must seek 345 reregistration with the department consistent with the 346 parameters of initial registration under subsection (1) 347 according to a schedule developed by the department. During the 348 reregistration process, if the department determines that the 349 performance of such procedures in the office creates a 350 significant risk to patient safety and that the interests of 351 patient safety would be better served if such procedures were 352 instead regulated under the requirements of ambulatory surgical 353 center licensure under chapter 395: 354 (a)The department must notify the Agency for Health Care 355 Administration of its determination; 356 (b)The agency must inspect the office and determine, in 357 the interest of patient safety, whether the office is a 358 candidate for ambulatory surgical center licensure 359 notwithstanding the offices failure to meet all requirements 360 associated with such licensure at the time of inspection and 361 notwithstanding any pertinent exceptions provided under s. 362 395.002(3). 363 364 If the agency determines that an office is a candidate for 365 ambulatory surgical center licensure under paragraph (b), the 366 agency must notify the office and the department, and the office 367 must cease performing procedures described in this subsection. 368 The office may not recommence performing such procedures without 369 first relinquishing its registration under this section and 370 attaining ambulatory surgery center licensure under chapter 395. 371 Section 3.The Department of Health shall develop a 372 schedule for reregistration of offices affected by the 373 amendments made to s. 458.328(1) or s. 459.0138(1), Florida 374 Statutes, by this act. Registration of all such offices must be 375 completed by December 1, 2024. 376 Section 4.This act shall take effect upon becoming a law.