HB 1561 2024
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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
A bill to be entitled 1
An act relating to office surgeries; amending ss. 2
458.328 and 459.0138, F.S.; revising the types of 3
procedures for which a medical office must register 4
with the Department of Health to perform office 5
surgeries; deleting obsolete language; making 6
technical and clarifying changes; revising standards 7
of practice for office surgeries; requiring medical 8
offices already registered with the department to 9
perform certain office surgeries as of a specified 10
date to reregister if such offices perform specified 11
procedures; specifying notification and inspection 12
procedures for the department and the Agency for 13
Health Care Administration in the event that, during 14
the reregistration process, the department determines 15
that the performance of specified procedures in an 16
office creates a risk of patient safety such that the 17
office should instead be regulated as an ambulatory 18
surgical center; requiring an office to cease 19
performing the specified procedures and relinquish its 20
office surgery registration and instead seek licensure 21
as an ambulatory surgical center under such 22
circumstances; requiring the department to develop a 23
schedule for reregistration of medical offices 24
affected by this act, to be completed by a specified 25
HB 1561 2024
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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
date; providing an effective date. 26
27
Be It Enacted by the Legislature of the State of Florida: 28
29
Section 1. Paragraphs (a), (b), and (h) of subsection (1) 30
and subsection (2) of section 458.328, Florida Statutes, are 31
amended, and subsection (4) is added to that section, to read: 32
458.328 Office surgeries. — 33
(1) REGISTRATION.— 34
(a)1. An office in which a physician performs a 35
liposuction procedure in which more than 1,000 cubic centimeters 36
of supernatant fat is temporarily or permanently removed, a 37
liposuction procedure in which the patient is rotated 180 38
degrees or more during the procedure, a gluteal fat grafting 39
procedure, a Level II office surgery, or a Level III office 40
surgery must register with the department. unless the office is 41
licensed as A facility licensed under chapter 390 or chapter 395 42
may not be registered under this section . 43
2. The department must complete an inspection of any 44
office seeking registration under this section before the off ice 45
may be registered. 46
(b) By January 1, 2020, Each office registered under this 47
section or s. 459.0138 must designate a physician who is 48
responsible for the office's compliance with the office health 49
and safety requirements of this section and rules ado pted 50
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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
hereunder. A designated physician must have a full, active, and 51
unencumbered license under this chapter or chapter 459 and shall 52
practice at the office for which he or she has assumed 53
responsibility. Within 10 calendar days after the termination of 54
a designated physician relationship, the office must notify the 55
department of the designation of another physician to serve as 56
the designated physician. The department may suspend the 57
registration of an office if the office fails to comply with the 58
requirements of this paragraph. 59
(h) A physician may only perform a procedure or surgery 60
identified in paragraph (a) in an office that is registered with 61
the department. The board shall impose a fine of $5,000 per day 62
on a physician who performs a procedure or sur gery in an office 63
that is not registered with the department. 64
(2) STANDARDS OF PRACTICE. — 65
(a) A physician may not perform any surgery or procedure 66
identified in paragraph (1)(a) in a setting other than an office 67
registered under this section or a facil ity licensed under 68
chapter 390 or chapter 395, as applicable. The board shall 69
impose a fine of $5,000 per incident on a physician who violates 70
this paragraph performing a gluteal fat grafting procedure in an 71
office surgery setting shall adhere to standards of practice 72
pursuant to this subsection and rules adopted by the board . 73
(b) Office surgeries may not: 74
1. Be a type of surgery that generally results in blood 75
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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
loss of more than 10 percent of estimated blood volume in a 76
patient with a normal hemoglobin level; 77
2. Require major or prolonged intracranial, intrathoracic, 78
abdominal, or joint replacement procedures, except for 79
laparoscopic procedures; 80
3. Involve major blood vessels and be performed with 81
direct visualization by open exposure of the major bl ood vessel, 82
except for percutaneous endovascular intervention; or 83
4. Be emergent or life threatening. 84
(c) A physician performing a gluteal fat grafting 85
procedure in an office surgery setting shall adhere to standards 86
of practice under this subsection and rules adopted by the 87
board, which include, but are not limited to, all of the 88
following: 89
1. A physician performing a gluteal fat grafting procedure 90
must conduct an in-person examination of the patient while 91
physically present in the same room as the patient no later than 92
the day before the procedure. 93
2. Before a physician may delegate any duties during a 94
gluteal fat grafting procedure, the patient must provide 95
written, informed consent for such delegation. Any duty 96
delegated by a physician during a gluteal fat grafting procedure 97
must be performed under the direct supervision of the physician 98
performing such procedure. Fat extraction and gluteal fat 99
injections must be performed by the physician and may not be 100
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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
delegated. 101
3. Fat may only be injected into the subcutaneous space of 102
the patient and may not cross the fascia overlying the gluteal 103
muscle. Intramuscular or submuscular fat injections are 104
prohibited. 105
4. When the physician performing a gluteal fat grafting 106
procedure injects fat into the subcutaneous space of the 107
patient, the physician must use ultrasound guidance, or guidance 108
with other technology authorized under board rule which equals 109
or exceeds the quality of ultrasound, during the placement and 110
navigation of the cannula to ensure that the fat is injected 111
into the subcutaneous space of the patient above the fascia 112
overlying the gluteal muscle. Such guidance with the use of 113
ultrasound or other technology is not required for other 114
portions of such procedure. 115
5. An office in which a physician performs gluteal fat 116
grafting procedures must at all times maintain a ratio of one 117
physician to one patient during all phases of the procedure, 118
beginning with the administration of anesthesia to the patient 119
and concluding with the extubation of the patient. After a 120
physician has commenced, and while he or she is engaged in, a 121
gluteal fat grafting procedure, the physician may not commence 122
or engage in another gluteal fat grafting procedure or any other 123
procedure with anothe r patient at the same time. 124
(d) If a procedure in an office surgery setting results in 125
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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
hospitalization, the incident must be reported as an adverse 126
incident pursuant to s. 458.351. 127
(e) An office in which a physician performs gluteal fat 128
grafting procedures must at all times maintain a ratio of one 129
physician to one patient during all phases of the procedure, 130
beginning with the administration of anesthesia to the patient 131
and concluding with the extubation of the patient. After a 132
physician has commenced, a nd while he or she is engaged in, a 133
gluteal fat grafting procedure, the physician may not commence 134
or engage in another gluteal fat grafting procedure or any other 135
procedure with another patient at the same time. 136
(4) REREGISTRATION. —An office that regist ered under this 137
section before July 1, 2024, in which a physician performs 138
liposuction procedures that include a patient being rotated 180 139
degrees or more during the procedure or in which a physician 140
performs gluteal fat grafting procedures must seek 141
reregistration with the department consistent with the 142
parameters of initial registration under subsection (1) 143
according to a schedule developed by the department. During the 144
reregistration process, if the department determines that the 145
performance of such proc edures in the office creates a 146
significant risk to patient safety and that the interests of 147
patient safety would be better served if such procedures were 148
instead regulated under the requirements of ambulatory surgical 149
center licensure under chapter 395: 150
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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
(a) The department must notify the Agency for Health Care 151
Administration of its determination; 152
(b) The agency must inspect the office and determine, in 153
the interest of patient safety, whether the office is a 154
candidate for ambulatory surgical center licen sure 155
notwithstanding the office's failure to meet all requirements 156
associated with such licensure at the time of inspection and 157
notwithstanding the exceptions provided under s. 395.002(3). 158
159
If the agency determines that an office is a candidate for 160
ambulatory surgical center licensure under paragraph (b), the 161
agency must notify the office and the department, and the office 162
must cease performing procedures described in this subsection. 163
The office may not recommence performing such procedures without 164
first relinquishing its registration under this section and 165
attaining ambulatory surgery center licensure under chapter 395. 166
Section 2. Paragraphs (a), (b), and (h) of subsection (1) 167
and subsection (2) of section 459.0138, Florida Statutes, are 168
amended, and subsection (4) is added to that section, to read: 169
459.0138 Office surgeries. — 170
(1) REGISTRATION.— 171
(a)1. An office in which a physician performs a 172
liposuction procedure in which more than 1,000 cubic centimeters 173
of supernatant fat is temporarily or perma nently removed, a 174
liposuction procedure in which the patient is rotated 180 175
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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
degrees or more during the procedure, a gluteal fat grafting 176
procedure, a Level II office surgery, or a Level III office 177
surgery must register with the department . unless the office is 178
licensed as A facility licensed under chapter 390 or chapter 395 179
may not be registered under this section . 180
2. The department must complete an inspection of any 181
office seeking registration under this section before the office 182
may be registered. 183
(b) By January 1, 2020, Each office registered under this 184
section or s. 458.328 must designate a physician who is 185
responsible for the office's compliance with the office health 186
and safety requirements of this section and rules adopted 187
hereunder. A designated physician must have a full, active, and 188
unencumbered license under this chapter or chapter 458 and shall 189
practice at the office for which he or she has assumed 190
responsibility. Within 10 calendar days after the termination of 191
a designated physician relation ship, the office must notify the 192
department of the designation of another physician to serve as 193
the designated physician. The department may suspend a 194
registration for an office if the office fails to comply with 195
the requirements of this paragraph. 196
(h) A physician may only perform a procedure or surgery 197
identified in paragraph (a) in an office that is registered with 198
the department. The board shall impose a fine of $5,000 per day 199
on a physician who performs a procedure or surgery in an office 200
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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
that is not registered with the department. 201
(2) STANDARDS OF PRACTICE. — 202
(a) A physician may not perform any surgery or procedure 203
identified in paragraph (1)(a) in a setting other than an office 204
registered under this section or a facility licensed under 205
chapter 390 or chapter 395, as applicable. The board shall 206
impose a fine of $5,000 per incident on a physician who violates 207
this paragraph performing a gluteal fat grafting procedure in an 208
office surgery setting shall adhere to standards of practice 209
pursuant to this subsection and rules adopted by the board . 210
(b) Office surgeries may not: 211
1. Be a type of surgery that generally results in blood 212
loss of more than 10 percent of estimated blood volume in a 213
patient with a normal hemoglobin level; 214
2. Require major or p rolonged intracranial, intrathoracic, 215
abdominal, or joint replacement procedures, except for 216
laparoscopic procedures; 217
3. Involve major blood vessels and be performed with 218
direct visualization by open exposure of the major blood vessel, 219
except for percutaneous endovascular intervention; or 220
4. Be emergent or life threatening. 221
(c) A physician performing a gluteal fat grafting 222
procedure in an office surgery setting shall adhere to standards 223
of practice under this subsection and rules adopted by the 224
board, which include, but are not limited to, all of the 225
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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
following: 226
1. A physician performing a gluteal fat grafting procedure 227
must conduct an in-person examination of the patient while 228
physically present in the same room as the patient no later than 229
the day before the procedure. 230
2. Before a physician may delegate any duties during a 231
gluteal fat grafting procedure, the patient must provide 232
written, informed consent for such delegation. Any duty 233
delegated by a physician during a gluteal fat grafting procedure 234
must be performed under the direct supervision of the physician 235
performing such procedure. Fat extraction and gluteal fat 236
injections must be performed by the physician and may not be 237
delegated. 238
3. Fat may only be injected into the subcutaneous space of 239
the patient and may not cross the fascia overlying the gluteal 240
muscle. Intramuscular or submuscular fat injections are 241
prohibited. 242
4. When the physician performing a gluteal fat grafting 243
procedure injects fat into the subcutaneous space of the 244
patient, the physician must use ultrasound guidance, or guidance 245
with other technology authorized under board rule which equals 246
or exceeds the quality of ultrasound, during the placement and 247
navigation of the cannula to ensure that the fat is injected 248
into the subcutaneous space of the patient above the fascia 249
overlying the gluteal muscle. Such guidance with the use of 250
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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
ultrasound or other technology is not required for other 251
portions of such procedure. 252
5. An office in which a physician performs gluteal fat 253
grafting procedures must at all times maintain a ratio of one 254
physician to one patient during all phases of the procedure, 255
beginning with the administration of anesthesia to the patient 256
and concluding with the extubation of the patient. After a 257
physician has commenced, and while he or she is engaged in, a 258
gluteal fat grafting procedure, the physician may not commence 259
or engage in another gluteal fat grafting procedure or any other 260
procedure with another patient at the same time. 261
(d) If a procedure in an office su rgery setting results in 262
hospitalization, the incident must be reported as an adverse 263
incident pursuant to s. 458.351. 264
(e) An office in which a physician performs gluteal fat 265
grafting procedures must at all times maintain a ratio of one 266
physician to one patient during all phases of the procedure, 267
beginning with the administration of anesthesia to the patient 268
and concluding with the extubation of the patient. After a 269
physician has commenced, and while he or she is engaged in, a 270
gluteal fat grafting procedu re, the physician may not commence 271
or engage in another gluteal fat grafting procedure or any other 272
procedure with another patient at the same time. 273
(4) REREGISTRATION. —An office that registered under this 274
section before July 1, 2024, in which a physicia n performs 275
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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
liposuction procedures that include a patient being rotated 180 276
degrees or more during the procedure or in which a physician 277
performs gluteal fat grafting procedures must seek 278
reregistration with the department consistent with the 279
parameters of initial registration under subsection (1) 280
according to a schedule developed by the department. During the 281
reregistration process, if the department determines that the 282
performance of such procedures in the office creates a 283
significant risk to patient safet y and that the interests of 284
patient safety would be better served if such procedures were 285
instead regulated under the requirements of ambulatory surgical 286
center licensure under chapter 395: 287
(a) The department must notify the Agency for Health Care 288
Administration of its determination; 289
(b) The agency must inspect the office and determine, in 290
the interest of patient safety, whether the office is a 291
candidate for ambulatory surgical center licensure 292
notwithstanding the office's failure to meet all requiremen ts 293
associated with such licensure at the time of inspection and 294
notwithstanding the exceptions provided under s. 395.002(3). 295
296
If the agency determines that an office is a candidate for 297
ambulatory surgical center licensure under paragraph (b), the 298
agency must notify the office and the department, and the office 299
must cease performing procedures described in this subsection. 300
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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
The office may not recommence performing such procedures without 301
first relinquishing its registration under this section and 302
attaining ambulatory surgery center licensure under chapter 395. 303
Section 3. The Department of Health shall develop a 304
schedule for reregistration of offices affected by the 305
amendments made to s. 458.328(1) or s. 459.0138(1), Florida 306
Statutes, by this act. Registrat ion of all such offices must be 307
completed by December 1, 2024. 308
Section 4. This act shall take effect upon becoming a law. 309