Florida 2025 Regular Session

Florida House Bill H0309 Compare Versions

Only one version of the bill is available at this time.

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3	3	HB 309 2025
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10	10	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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13	13
14	14	A bill to be entitled 1
15	15	An act relating to office surgery standards of 2
16	16	practice; providing a short title; amending ss. 3
17	17	458.328 and 459.0138, F.S.; providing a registration 4
18	18	requirement for offices that perform specified 5
19	19	surgeries; revising the standards of practice for 6
20	20	office surgeries and health care professionals who 7
21	21	practice at such offices; providing liability 8
22	22	requirements; providing an effective date. 9
23	23	10
24	24	Be It Enacted by the Legis lature of the State of Florida: 11
25	25	12
26	26	Section 1. This act may be cited as "Hillary's Law." 13
27	27	Section 2. Subsection (3) of section 458.328, Florida 14
28	28	Statutes, is renumbered as subsection (4), paragraph (e) of 15
29	29	subsection (1) and subsection (2) are amended, a nd a new 16
30	30	subsection (3) is added to that section, to read: 17
31	31	458.328 Office surgeries. — 18
32	32	(1) REGISTRATION.— 19
33	33	(e)1. The department shall inspect a registered office at 20
34	34	least annually, including a review of patient records, to ensure 21
35	35	that the office is in compliance with this section and rules 22
36	36	adopted hereunder unless the office is accredited by a 23
37	37	nationally recognized accrediting agency approved by the board. 24
38	38	The inspection may be unannounced, except for the inspection of 25
39	39
40	40	HB 309 2025
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42	42
43	43
44	44	CODING: Words stricken are deletions; words underlined are additions.
45	45	hb309-00
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47	47	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
48	48
49	49
50	50
51	51	an office that meets the descripti on of a clinic specified in s. 26
52	52	458.3265(1)(a)3.h., and those wholly owned and operated 27
53	53	physician offices described in s. 458.3265(1)(a)3.g. which 28
54	54	perform procedures referenced in s. 458.3265(1)(a)3.h., which 29
55	55	must be announced. 30
56	56	2. The department must imme diately suspend the 31
57	57	registration of a registered office that refuses an inspection 32
58	58	under subparagraph 1. The office must close during such 33
59	59	suspension. The suspension must remain in effect for at least 14 34
60	60	consecutive days and may not terminate until the dep artment 35
61	61	issues a written declaration that the office may reopen 36
62	62	following the department's completion of an inspection of the 37
63	63	office. 38
64	64	3. As a condition of registration, each office must also 39
65	65	be inspected by the Joint Commission on Accreditation of 40
66	66	Healthcare Organizations (JCAHO) and conform to the JCAHO 41
67	67	standards for a stand -alone ambulatory surgery center and meet 42
68	68	any other requirements set by JCAHO. 43
69	69	(2) STANDARDS OF PRACTICE. — 44
70	70	(a) A physician may not perform any surgery or procedure 45
71	71	identified in paragraph (1)(a) in a setting other than an office 46
72	72	surgery setting registered under this section or a facility 47
73	73	licensed under chapter 390 or chapter 395, as applicable. The 48
74	74	board shall impose a fine of $5,000 per incident on a physician 49
75	75	who violates this pa ragraph. 50
76	76
77	77	HB 309 2025
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80	80
81	81	CODING: Words stricken are deletions; words underlined are additions.
82	82	hb309-00
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84	84	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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88	88	(b) Office surgeries may not: 51
89	89	1. Be a type of surgery that generally results in blood 52
90	90	loss of more than 10 percent of estimated blood volume in a 53
91	91	patient with a normal hemoglobin level; 54
92	92	2. Require major or prolonged intracranial, intrathorac ic, 55
93	93	abdominal, or joint replacement procedures, except for 56
94	94	laparoscopic procedures; 57
95	95	3. Involve major blood vessels and be performed with 58
96	96	direct visualization by open exposure of the major blood vessel, 59
97	97	except for percutaneous endovascular intervention; or 60
98	98	4. Be emergent or life threatening. 61
99	99	(c) A physician performing a gluteal fat grafting 62
100	100	procedure in an office surgery setting shall adhere to standards 63
101	101	of practice under this subsection and rules adopted by the board 64
102	102	which include, but are not limite d to, all of the following: 65
103	103	1. A physician performing a gluteal fat grafting procedure 66
104	104	must conduct an in-person examination of the patient while 67
105	105	physically present in the same room as the patient no later than 68
106	106	the day before the procedure. 69
107	107	2. Before a physician may delegate any duties during a 70
108	108	gluteal fat grafting procedure, the patient must provide 71
109	109	written, informed consent for such delegation. Any duty 72
110	110	delegated by a physician during a gluteal fat grafting procedure 73
111	111	must be performed under the direct supervision of the physician 74
112	112	performing such procedure. Fat extraction and gluteal fat 75
113	113
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121	121	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
122	122
123	123
124	124
125	125	injections must be performed by the physician and may not be 76
126	126	delegated. 77
127	127	3. Fat may only be injected into the subcutaneous space of 78
128	128	the patient and may not cross the f ascia overlying the gluteal 79
129	129	muscle. Intramuscular or submuscular fat injections are 80
130	130	prohibited. 81
131	131	4. When the physician performing a gluteal fat grafting 82
132	132	procedure injects fat into the subcutaneous space of the 83
133	133	patient, the physician must use ultrasound gu idance, or guidance 84
134	134	with other technology authorized under board rule which equals 85
135	135	or exceeds the quality of ultrasound, during the placement and 86
136	136	navigation of the cannula to ensure that the fat is injected 87
137	137	into the subcutaneous space of the patient above the fascia 88
138	138	overlying the gluteal muscle. Such guidance with the use of 89
139	139	ultrasound or other technology is not required for other 90
140	140	portions of such procedure. 91
141	141	5. An office in which a physician performs gluteal fat 92
142	142	grafting procedures must at all times maint ain a ratio of one 93
143	143	physician to one patient during all phases of the procedure, 94
144	144	beginning with the administration of anesthesia to the patient 95
145	145	and concluding with the extubation of the patient. After a 96
146	146	physician has commenced, and while he or she is engage d in, a 97
147	147	gluteal fat grafting procedure, the physician may not commence 98
148	148	or engage in another gluteal fat grafting procedure or any other 99
149	149	procedure with another patient at the same time. 100
150	150
151	151	HB 309 2025
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155	155	CODING: Words stricken are deletions; words underlined are additions.
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158	158	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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161	161
162	162	(d) A physician may not: 101
163	163	1. Perform a minor or major surgery on an immediate family 102
164	164	member. As used in this subparagraph, the term "immediate family 103
165	165	member" means a parent, spouse, child, or sibling. 104
166	166	2. Alter or change an informed consent form for a 105
167	167	procedure after the consent has been signed, or after any 106
168	168	sedative drugs are administered to the patient. 107
169	169	(e) All health care professionals performing duties at a 108
170	170	registered office must be: 109
171	171	1. Licensed or certified, and may not perform surgeries or 110
172	172	procedures outside the scope of his or her license or 111
173	173	certification. 112
174	174	2. Certified in advanced cardiac life support and maintain 113
175	175	certification through continuing education every 2 years. 114
176	176	(f) A registered office may only perform procedures or 115
177	177	surgeries during regular office hours and must have: 116
178	178	1. Appropriate staff on premis es for procedures and 117
179	179	surgeries and administrative duties. 118
180	180	2. On the premises at all times a functioning automated 119
181	181	external defibrillator device as defined in s. 768.1325(2)(b) 120
182	182	and all necessary critical care equipment and medications. 121
183	183	3. Preoperative guidelines, intraoperative protocols, and 122
184	184	postoperative recovery guidelines in place that meet the 123
185	185	standards of any stand -alone ambulatory surgery center for each 124
186	186	surgery and procedure, and any followup surgeries and 125
187	187
188	188	HB 309 2025
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190	190
191	191
192	192	CODING: Words stricken are deletions; words underlined are additions.
193	193	hb309-00
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195	195	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
196	196
197	197
198	198
199	199	procedures, for every patient. 126
200	200	4. A certified registered nurse anesthetist onsite, who is 127
201	201	supervised by a board -certified anesthesiologist offsite, to 128
202	202	properly administer and oversee anesthesia gases including 129
203	203	nitrous oxide, sedatives, narcotic analgesics, intravenous local 130
204	204	anesthetics, and the antidote to local anesthetic overdosage, 131
205	205	which must be kept onsite and accessible during a procedure or 132
206	206	surgery. 133
207	207	5. Proper protocols in place for storing, accessing, 134
208	208	administering, and dispensing sedatives and drugs listed in 135
209	209	Schedule II, Schedule III , or Schedule IV of s. 893.03. 136
210	210	(f)(d) If a procedure in an office surgery setting results 137
211	211	in hospitalization, the incident must be reported as an adverse 138
212	212	incident pursuant to s. 458.351 within 48 hours after its 139
213	213	occurrence. If an adverse incident occurs due to a local 140
214	214	anesthetic, all vials related to the local anesthetic and its 141
215	215	constitution that were administered must be saved as evidence 142
216	216	for the department and the sheriff's office or municipal police 143
217	217	department. 144
218	218	(g) A registered office having to under go any type of 145
219	219	construction or refurbishment of its structure may not perform 146
220	220	any surgeries or procedures in the building until completion of 147
221	221	the construction or refurbishment. 148
222	222	(h) An oversight committee shall be created by the 149
223	223	department that oversees a ny violations of this section and 150
224	224
225	225	HB 309 2025
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227	227
228	228
229	229	CODING: Words stricken are deletions; words underlined are additions.
230	230	hb309-00
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232	232	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
233	233
234	234
235	235
236	236	reports such violations to the department. 151
237	237	(3) LIABILITY.—A physician must maintain medical 152
238	238	malpractice insurance or provide proof of financial 153
239	239	responsibility in an amount of at least $1 million. 154
240	240	Section 3. Subsectio n (3) of section 459.0138, Florida 155
241	241	Statutes, is renumbered as subsection (4), paragraph (e) of 156
242	242	subsection (1) and subsection (2) are amended, and a new 157
243	243	subsection (3) is added to that section, to read: 158
244	244	459.0138 Office surgeries. — 159
245	245	(1) REGISTRATION.— 160
246	246	(e)1. The department shall inspect a registered office at 161
247	247	least annually, including a review of patient records, to ensure 162
248	248	that the office is in compliance with this section and rules 163
249	249	adopted hereunder unless the office is accredited by a 164
250	250	nationally recognized accrediting agency approved by the board. 165
251	251	The inspection may be unannounced, except for the inspection of 166
252	252	an office that meets the description of a clinic specified in s. 167
253	253	459.0137(1)(a)3.h., and those wholly owned and operated 168
254	254	physician offices describ ed in s. 459.0137(1)(a)3.g. which 169
255	255	perform procedures referenced in s. 459.0137(1)(a)3.h., which 170
256	256	must be announced. 171
257	257	2. The department must immediately suspend the 172
258	258	registration of a registered office that refuses an inspection 173
259	259	under subparagraph 1. The off ice must close during such 174
260	260	suspension. The suspension must remain in effect for at least 14 175
261	261
262	262	HB 309 2025
263	263
264	264
265	265
266	266	CODING: Words stricken are deletions; words underlined are additions.
267	267	hb309-00
268	268	Page 8 of 12
269	269	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
270	270
271	271
272	272
273	273	consecutive days and may not terminate until the department 176
274	274	issues a written declaration that the office may reopen 177
275	275	following the department's completion of an insp ection of the 178
276	276	office. 179
277	277	3. As a condition of registration, each office must also 180
278	278	be inspected by the Joint Commission on Accreditation of 181
279	279	Healthcare Organizations (JCAHO) and conform to the JCAHO 182
280	280	standards for a stand -alone ambulatory surgery center and meet 183
281	281	any other requirements set by JCAHO. 184
282	282	(2) STANDARDS OF PRACTICE. — 185
283	283	(a) A physician may not perform any surgery or procedure 186
284	284	identified in paragraph (1)(a) in a setting other than an office 187
285	285	surgery setting registered under this section or a facility 188
286	286	licensed under chapter 390 or chapter 395, as applicable. The 189
287	287	board shall impose a fine of $5,000 per incident on a physician 190
288	288	who violates this paragraph. 191
289	289	(b) Office surgeries may not: 192
290	290	1. Be a type of surgery that generally results in blood 193
291	291	loss of more than 10 percent of estimated blood volume in a 194
292	292	patient with a normal hemoglobin level; 195
293	293	2. Require major or prolonged intracranial, intrathoracic, 196
294	294	abdominal, or joint replacement procedures, except for 197
295	295	laparoscopic procedures; 198
296	296	3. Involve major blood v essels and be performed with 199
297	297	direct visualization by open exposure of the major blood vessel, 200
298	298
299	299	HB 309 2025
300	300
301	301
302	302
303	303	CODING: Words stricken are deletions; words underlined are additions.
304	304	hb309-00
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306	306	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
307	307
308	308
309	309
310	310	except for percutaneous endovascular intervention; or 201
311	311	4. Be emergent or life threatening. 202
312	312	(c) A physician performing a gluteal fat grafting 203
313	313	procedure in an office surgery setting shall adhere to standards 204
314	314	of practice under this subsection and rules adopted by the board 205
315	315	which include, but are not limited to, all of the following: 206
316	316	1. A physician performing a gluteal fat grafting procedure 207
317	317	must conduct an in-person examination of the patient while 208
318	318	physically present in the same room as the patient no later than 209
319	319	the day before the procedure. 210
320	320	2. Before a physician may delegate any duties during a 211
321	321	gluteal fat grafting procedure, the patient must provide 212
322	322	written, informed consent for such delegation. Any duty 213
323	323	delegated by a physician during a gluteal fat grafting procedure 214
324	324	must be performed under the direct supervision of the physician 215
325	325	performing such procedure. Fat extraction and gluteal fat 216
326	326	injections must be perf ormed by the physician and may not be 217
327	327	delegated. 218
328	328	3. Fat may only be injected into the subcutaneous space of 219
329	329	the patient and may not cross the fascia overlying the gluteal 220
330	330	muscle. Intramuscular or submuscular fat injections are 221
331	331	prohibited. 222
332	332	4. When the physician performing a gluteal fat grafting 223
333	333	procedure injects fat into the subcutaneous space of the 224
334	334	patient, the physician must use ultrasound guidance, or guidance 225
335	335
336	336	HB 309 2025
337	337
338	338
339	339
340	340	CODING: Words stricken are deletions; words underlined are additions.
341	341	hb309-00
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343	343	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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345	345
346	346
347	347	with other technology authorized under board rule which equals 226
348	348	or exceeds the quality of ul trasound, during the placement and 227
349	349	navigation of the cannula to ensure that the fat is injected 228
350	350	into the subcutaneous space of the patient above the fascia 229
351	351	overlying the gluteal muscle. Such guidance with the use of 230
352	352	ultrasound or other technology is not re quired for other 231
353	353	portions of such procedure. 232
354	354	5. An office in which a physician performs gluteal fat 233
355	355	grafting procedures must at all times maintain a ratio of one 234
356	356	physician to one patient during all phases of the procedure, 235
357	357	beginning with the administrati on of anesthesia to the patient 236
358	358	and concluding with the extubation of the patient. After a 237
359	359	physician has commenced, and while he or she is engaged in, a 238
360	360	gluteal fat grafting procedure, the physician may not commence 239
361	361	or engage in another gluteal fat graftin g procedure or any other 240
362	362	procedure with another patient at the same time. 241
363	363	(d) A physician may not: 242
364	364	1. Perform a minor or major surgery on an immediate family 243
365	365	member. As used in this subparagraph, the term "immediate family 244
366	366	member" means a parent, spous e, child, or sibling. 245
367	367	2. Alter or change an informed consent form for a 246
368	368	procedure after the consent has been signed, or after any 247
369	369	sedative drugs are administered to the patient. 248
370	370	(e) All health care professionals performing duties at a 249
371	371	registered office must be: 250
372	372
373	373	HB 309 2025
374	374
375	375
376	376
377	377	CODING: Words stricken are deletions; words underlined are additions.
378	378	hb309-00
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380	380	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
381	381
382	382
383	383
384	384	1. Licensed or certified, and may not perform surgeries or 251
385	385	procedures outside the scope of his or her license or 252
386	386	certification. 253
387	387	2. Certified in advanced cardiac life support and maintain 254
388	388	certification through continuing education every 2 year s. 255
389	389	(f) A registered office may only perform procedures or 256
390	390	surgeries during regular office hours and must have: 257
391	391	1. Appropriate staff on premises for procedures and 258
392	392	surgeries and administrative duties. 259
393	393	2. On the premises at all times a functioning auto mated 260
394	394	external defibrillator device as defined in s. 768.1325(2)(b) 261
395	395	and all necessary critical care equipment and medications. 262
396	396	3. Preoperative guidelines, intraoperative protocols, and 263
397	397	postoperative recovery guidelines in place that meet the 264
398	398	standards of any stand-alone ambulatory surgery center for each 265
399	399	surgery and procedure, and any followup surgeries and 266
400	400	procedures, for every patient. 267
401	401	4. A certified registered nurse anesthetist onsite, who is 268
402	402	supervised by a board -certified anesthesiologist offsite, to 269
403	403	properly administer and oversee anesthesia gases including 270
404	404	nitrous oxide, sedatives, narcotic analgesics, intravenous local 271
405	405	anesthetics, and the antidote to local anesthetic overdosage, 272
406	406	which must be kept onsite and accessible during a procedure or 273
407	407	surgery. 274
408	408	5. Proper protocols in place for storing, accessing, 275
409	409
410	410	HB 309 2025
411	411
412	412
413	413
414	414	CODING: Words stricken are deletions; words underlined are additions.
415	415	hb309-00
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417	417	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
418	418
419	419
420	420
421	421	administering, and dispensing sedatives and drugs listed in 276
422	422	Schedule II, Schedule III, or Schedule IV of s. 893.03. 277
423	423	(f)(d) If a procedure in an office surgery setting results 278
424	424	in hospitalization, the incident must be reported as an adverse 279
425	425	incident pursuant to s. 458.351 within 48 hours after its 280
426	426	occurrence. If an adverse incident occurs due to a local 281
427	427	anesthetic, all vials r elated to the local anesthetic and its 282
428	428	constitution that were administered must be saved as evidence 283
429	429	for the department and the sheriff's office or municipal police 284
430	430	department. 285
431	431	(g) A registered office having to undergo any type of 286
432	432	construction or refurbi shment of its structure may not perform 287
433	433	any office surgeries or procedures in the building until 288
434	434	completion of the construction or refurbishment. 289
435	435	(h) An oversight committee shall be created by the 290
436	436	department that oversees any violations of this section a nd 291
437	437	reports such violations to the department. 292
438	438	(3) LIABILITY.—A physician must maintain medical 293
439	439	malpractice insurance or provide proof of financial 294
440	440	responsibility in an amount of at least $1 million. 295
441	441	Section 4. This act shall take effect July 1, 2025. 296