FL
Florida House Bill H1561

Florida 2024 Regular Session

Florida House Bill H1561 Compare Versions

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1010 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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14+A bill to be entitled 1
1515 An act relating to office surgeries; amending ss. 2
1616 458.328 and 459.0138, F.S.; revising the types of 3
1717 procedures for which a medical office must register 4
1818 with the Department of Health to perform office 5
1919 surgeries; deleting obsolete language; making 6
2020 technical and clarifying changes; requiring medical 7
2121 offices performing specified office surgeries to 8
2222 demonstrate to the department that they have 9
2323 established financial res ponsibility in a specified 10
2424 manner; revising standards of practice for office 11
2525 surgeries; amending s. 456.074, F.S.; correcting a 12
2626 cross-reference; providing an effective date. 13
2727 14
2828 Be It Enacted by the Legislature of the State of Florida: 15
2929 16
3030 Section 1. Paragraphs (a), (b), (c), and (h) of subsection 17
3131 (1) and subsection (2) of section 458.328, Florida Statutes, are 18
3232 amended to read: 19
3333 458.328 Office surgeries. — 20
3434 (1) REGISTRATION.— 21
3535 (a)1. An office in which a physician performs a 22
3636 liposuction procedure in whic h more than 1,000 cubic centimeters 23
3737 of supernatant fat is temporarily or permanently removed, a 24
3838 Level II office surgery, or a Level III office surgery must 25
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4747 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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5151 register with the department . unless the office is licensed as A 26
5252 facility licensed under chapter 390 or chapter 395 may not be 27
5353 registered under this section . 28
5454 2. The department must complete an inspection of any 29
5555 office seeking registration under this section before the office 30
5656 may be registered. 31
5757 (b) By January 1, 2020, Each office registered under this 32
5858 section or s. 459.0138 must designate a physician who is 33
5959 responsible for the office's compliance with the office health 34
6060 and safety requirements of this section and rules adopted 35
6161 hereunder. A designated physician must have a full, active, and 36
6262 unencumbered license under this chapter or chapter 459 and shall 37
6363 practice at the office for which he or she has assumed 38
6464 responsibility. Within 10 calendar days after the termination of 39
6565 a designated physician relationship, the office must notify the 40
6666 department of the de signation of another physician to serve as 41
6767 the designated physician. The department may suspend the 42
6868 registration of an office if the office fails to comply with the 43
6969 requirements of this paragraph. 44
7070 (c) As a condition of registration, each office must 45
7171 establish financial responsibility by demonstrating that it has 46
7272 met and continues to maintain, at a minimum, the same 47
7373 requirements applicable to physicians in ss. 458.320 and 48
7474 459.0085. An office in which a physician performs a gluteal fat 49
7575 grafting procedure mu st also establish financial responsibility 50
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8484 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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8888 by demonstrating that it has met and continues to maintain, at a 51
8989 minimum, the same requirements applicable to physicians in ss. 52
9090 458.320(2)(b) or (c) and 459.0085(2)(b) or (c), as applicable. 53
9191 Each physician practic ing at an office registered under this 54
9292 section or s. 459.0138 must meet the financial responsibility 55
9393 requirements under s. 458.320 or s. 459.0085, as applicable. 56
9494 (h) A physician may only perform a procedure or surgery 57
9595 identified in paragraph (a) in an of fice that is registered with 58
9696 the department. The board shall impose a fine of $5,000 per day 59
9797 on a physician who performs a procedure or surgery in an office 60
9898 that is not registered with the department. 61
9999 (2) STANDARDS OF PRACTICE. — 62
100100 (a) A physician may not perform any surgery or procedure 63
101101 identified in paragraph (1)(a) in a setting other than an office 64
102102 surgery setting registered under this section or a facility 65
103103 licensed under chapter 390 or chapter 395, as applicable. The 66
104104 board shall impose a fine of $5,000 per incident on a physician 67
105105 who violates this paragraph performing a gluteal fat grafting 68
106106 procedure in an office surgery setting shall adhere to standards 69
107107 of practice pursuant to this subsection and rules adopted by the 70
108108 board. 71
109109 (b) Office surgeries may n ot: 72
110110 1. Be a type of surgery that generally results in blood 73
111111 loss of more than 10 percent of estimated blood volume in a 74
112112 patient with a normal hemoglobin level; 75
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121121 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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125125 2. Require major or prolonged intracranial, intrathoracic, 76
126126 abdominal, or joint replacement procedures, except for 77
127127 laparoscopic procedures; 78
128128 3. Involve major blood vessels and be performed with 79
129129 direct visualization by open exposure of the major blood vessel, 80
130130 except for percutaneous endovascular intervention; or 81
131131 4. Be emergent or life threateni ng. 82
132132 (c) A physician performing a gluteal fat grafting 83
133133 procedure in an office surgery setting shall adhere to standards 84
134134 of practice under this subsection and rules adopted by the board 85
135135 which include, but are not limited to, all of the following: 86
136136 1. A physician performing a gluteal fat grafting procedure 87
137137 must conduct an in-person examination of the patient while 88
138138 physically present in the same room as the patient no later than 89
139139 the day before the procedure. 90
140140 2. Before a physician may delegate any duties du ring a 91
141141 gluteal fat grafting procedure, the patient must provide 92
142142 written, informed consent for such delegation. Any duty 93
143143 delegated by a physician during a gluteal fat grafting procedure 94
144144 must be performed under the direct supervision of the physician 95
145145 performing such procedure. Fat extraction and gluteal fat 96
146146 injections must be performed by the physician and may not be 97
147147 delegated. 98
148148 3. Fat may only be injected into the subcutaneous space of 99
149149 the patient and may not cross the fascia overlying the gluteal 100
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158158 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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162162 muscle. Intramuscular or submuscular fat injections are 101
163163 prohibited. 102
164164 4. When the physician performing a gluteal fat grafting 103
165165 procedure injects fat into the subcutaneous space of the 104
166166 patient, the physician must use ultrasound guidance, or guidance 105
167167 with other technology authorized under board rule which equals 106
168168 or exceeds the quality of ultrasound, during the placement and 107
169169 navigation of the cannula to ensure that the fat is injected 108
170170 into the subcutaneous space of the patient above the fascia 109
171171 overlying the gluteal musc le. Such guidance with the use of 110
172172 ultrasound or other technology is not required for other 111
173173 portions of such procedure. 112
174174 5. An office in which a physician performs gluteal fat 113
175175 grafting procedures must at all times maintain a ratio of one 114
176176 physician to one patient during all phases of the procedure, 115
177177 beginning with the administration of anesthesia to the patient 116
178178 and concluding with the extubation of the patient. After a 117
179179 physician has commenced, and while he or she is engaged in, a 118
180180 gluteal fat grafting procedur e, the physician may not commence 119
181181 or engage in another gluteal fat grafting procedure or any other 120
182182 procedure with another patient at the same time. 121
183183 (d) If a procedure in an office surgery setting results in 122
184184 hospitalization, the incident must be reported as an adverse 123
185185 incident pursuant to s. 458.351. 124
186186 (e) An office in which a physician performs gluteal fat 125
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195195 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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199199 grafting procedures must at all times maintain a ratio of one 126
200200 physician to one patient during all phases of the procedure, 127
201201 beginning with the administr ation of anesthesia to the patient 128
202202 and concluding with the extubation of the patient. After a 129
203203 physician has commenced, and while he or she is engaged in, a 130
204204 gluteal fat grafting procedure, the physician may not commence 131
205205 or engage in another gluteal fat graf ting procedure or any other 132
206206 procedure with another patient at the same time. 133
207207 Section 2. Paragraphs (a), (b), (c), and (h) of subsection 134
208208 (1) and subsection (2) of section 459.0138, Florida Statutes, 135
209209 are amended to read: 136
210210 459.0138 Office surgeries. — 137
211211 (1) REGISTRATION.— 138
212212 (a)1. An office in which a physician performs a 139
213213 liposuction procedure in which more than 1,000 cubic centimeters 140
214214 of supernatant fat is temporarily or permanently removed, a 141
215215 Level II office surgery, or a Level III office surgery must 142
216216 register with the department . unless the office is licensed as A 143
217217 facility licensed under chapter 390 or chapter 395 may not be 144
218218 registered under this section . 145
219219 2. The department must complete an inspection of any 146
220220 office seeking registration under this section before the office 147
221221 may be registered. 148
222222 (b) By January 1, 2020, Each office registered under this 149
223223 section or s. 458.328 must designate a physician who is 150
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232232 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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236236 responsible for the office's compliance with the office health 151
237237 and safety requirements of this section and rules adopted 152
238238 hereunder. A designated physician must have a full, active, and 153
239239 unencumbered license under this chapter or chapter 458 and shall 154
240240 practice at the office for which he or she has assumed 155
241241 responsibility. Within 10 calendar days after the ter mination of 156
242242 a designated physician relationship, the office must notify the 157
243243 department of the designation of another physician to serve as 158
244244 the designated physician. The department may suspend a 159
245245 registration for an office if the office fails to comply with 160
246246 the requirements of this paragraph. 161
247247 (c) As a condition of registration, each office must 162
248248 establish financial responsibility by demonstrating that it has 163
249249 met and continues to maintain, at a minimum, the same 164
250250 requirements applicable to physicians in ss. 45 8.320 and 165
251251 459.0085. An office in which a physician performs a gluteal fat 166
252252 grafting procedure must also establish financial responsibility 167
253253 by demonstrating that it has met and continues to maintain, at a 168
254254 minimum, the same requirements applicable to physicia ns in ss. 169
255255 458.320(2)(b) or (c) and 459.0085(2)(b) or (c), as applicable. 170
256256 Each physician practicing at an office registered under this 171
257257 section or s. 458.328 must meet the financial responsibility 172
258258 requirements under s. 458.320 or s. 459.0085, as applicable. 173
259259 (h) A physician may only perform a procedure or surgery 174
260260 identified in paragraph (a) in an office that is registered with 175
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269269 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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273273 the department. The board shall impose a fine of $5,000 per day 176
274274 on a physician who performs a procedure or surgery in an office 177
275275 that is not registered with the department. 178
276276 (2) STANDARDS OF PRACTICE. — 179
277277 (a) A physician may not perform any surgery or procedure 180
278278 identified in paragraph (1)(a) in a setting other than an office 181
279279 surgery setting registered under this section or a facility 182
280280 licensed under chapter 390 or chapter 395, as applicable. The 183
281281 board shall impose a fine of $5,000 per incident on a physician 184
282282 who violates this paragraph performing a gluteal fat grafting 185
283283 procedure in an office surgery setting shall adhere to standards 186
284284 of practice pursuant to this subsection and rules adopted by the 187
285285 board. 188
286286 (b) Office surgeries may not: 189
287287 1. Be a type of surgery that generally results in blood 190
288288 loss of more than 10 percent of estimated blood volume in a 191
289289 patient with a normal hemoglobin level; 192
290290 2. Require major or prolonged intracranial, intrathoracic, 193
291291 abdominal, or joint replacement procedures, except for 194
292292 laparoscopic procedures; 195
293293 3. Involve major blood vessels and be performed with 196
294294 direct visualization by open exposure of the major blood ves sel, 197
295295 except for percutaneous endovascular intervention; or 198
296296 4. Be emergent or life threatening. 199
297297 (c) A physician performing a gluteal fat grafting 200
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306306 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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310310 procedure in an office surgery setting shall adhere to standards 201
311311 of practice under this subsection and rule s adopted by the board 202
312312 which include, but are not limited to, all of the following: 203
313313 1. A physician performing a gluteal fat grafting procedure 204
314314 must conduct an in-person examination of the patient while 205
315315 physically present in the same room as the patient n o later than 206
316316 the day before the procedure. 207
317317 2. Before a physician may delegate any duties during a 208
318318 gluteal fat grafting procedure, the patient must provide 209
319319 written, informed consent for such delegation. Any duty 210
320320 delegated by a physician during a gluteal f at grafting procedure 211
321321 must be performed under the direct supervision of the physician 212
322322 performing such procedure. Fat extraction and gluteal fat 213
323323 injections must be performed by the physician and may not be 214
324324 delegated. 215
325325 3. Fat may only be injected into the subcutaneous space of 216
326326 the patient and may not cross the fascia overlying the gluteal 217
327327 muscle. Intramuscular or submuscular fat injections are 218
328328 prohibited. 219
329329 4. When the physician performing a gluteal fat grafting 220
330330 procedure injects fat into the subcutaneous s pace of the 221
331331 patient, the physician must use ultrasound guidance, or guidance 222
332332 with other technology authorized under board rule which equals 223
333333 or exceeds the quality of ultrasound, during the placement and 224
334334 navigation of the cannula to ensure that the fat is i njected 225
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343343 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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347347 into the subcutaneous space of the patient above the fascia 226
348348 overlying the gluteal muscle. Such guidance with the use of 227
349349 ultrasound or other technology is not required for other 228
350350 portions of such procedure. 229
351351 5. An office in which a physician perform s gluteal fat 230
352352 grafting procedures must at all times maintain a ratio of one 231
353353 physician to one patient during all phases of the procedure, 232
354354 beginning with the administration of anesthesia to the patient 233
355355 and concluding with the extubation of the patient. After a 234
356356 physician has commenced, and while he or she is engaged in, a 235
357357 gluteal fat grafting procedure, the physician may not commence 236
358358 or engage in another gluteal fat grafting procedure or any other 237
359359 procedure with another patient at the same time. 238
360360 (d) If a procedure in an office surgery setting results in 239
361361 hospitalization, the incident must be reported as an adverse 240
362362 incident pursuant to s. 458.351. 241
363363 (e) An office in which a physician performs gluteal fat 242
364364 grafting procedures must at all times maintain a ratio of one 243
365365 physician to one patient during all phases of the procedure, 244
366366 beginning with the administration of anesthesia to the patient 245
367367 and concluding with the extubation of the patient. After a 246
368368 physician has commenced, and while he or she is engaged in, a 247
369369 gluteal fat grafting procedure, the physician may not commence 248
370370 or engage in another gluteal fat grafting procedure or any other 249
371371 procedure with another patient at the same time. 250
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380380 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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384384 Section 3. Subsection (6) of section 456.074, Florida 251
385385 Statutes, is amended to rea d 252
386386 456.074 Certain health care practitioners; immediate 253
387387 suspension of license. — 254
388388 (6) The department must issue an emergency order 255
389389 suspending or restricting the registration of an office 256
390390 registered under s. 458.328 or s. 459.0138 s. 459.0139 upon a 257
391391 finding of probable cause that the office or a physician 258
392392 practicing in the office is not in compliance with the standards 259
393393 of practice for office surgery adopted by the boards pursuant to 260
394394 s. 458.328 or s. 459.0138, as applicable, or is in violation of 261
395395 s. 458.331(1)(v) or s. 459.015(1)(z), and that such 262
396396 noncompliance or violation constitutes an immediate danger to 263
397397 the public. 264
398398 Section 4. This act shall take effect upon becoming a law. 265