Bill Text: FL S0732 | 2019 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Office Surgery
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2019-06-26 - Chapter No. 2019-130 [S0732 Detail]
Download: Florida-2019-S0732-Comm_Sub.html
Bill Title: Office Surgery
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2019-06-26 - Chapter No. 2019-130 [S0732 Detail]
Download: Florida-2019-S0732-Comm_Sub.html
Florida Senate - 2019 CS for CS for SB 732 By the Committees on Appropriations; and Health Policy; and Senator Flores 576-04628-19 2019732c2 1 A bill to be entitled 2 An act relating to clinics and office surgery; 3 amending s. 456.004, F.S.; requiring the Department of 4 Health to deny or revoke the registration of or impose 5 certain penalties against a facility where certain 6 office surgeries are performed under certain 7 circumstances; specifying provisions that apply 8 enforcement actions against such facilities; 9 authorizing the department to deny certain persons 10 associated with an office of which the registration 11 was revoked from registering a new office to perform 12 certain office surgery; amending s. 456.074, F.S.; 13 authorizing the department to issue an emergency order 14 suspending or restricting the registration of a 15 certain office if it makes certain findings; amending 16 s. 458.305, F.S.; defining terms; amending s. 458.309, 17 F.S.; requiring a physician who performs certain 18 office surgery and the office in which the surgery is 19 performed to maintain specified levels of financial 20 responsibility; authorizing the Board of Medicine to 21 adopt rules to administer the registration, 22 inspection, and safety of offices that perform certain 23 office surgery; requiring such an office to designate 24 a certain physician responsible for the office’s 25 compliance with specified provisions; authorizing the 26 department to suspend an office’s registration 27 certificate under certain circumstances; requiring the 28 department to conduct certain inspections; providing 29 an exception; requiring the board to adopt rules 30 governing the standard of care for physicians 31 practicing in such offices; requiring the board to 32 impose a specified fine on physicians who perform 33 certain office surgeries in an unregistered office; 34 amending s. 458.331, F.S.; providing that a physician 35 performing certain office surgeries in an unregistered 36 office constitutes grounds for denial of a license or 37 disciplinary action; amending s. 459.003, F.S.; 38 defining terms; amending s. 459.005, F.S.; requiring a 39 physician who performs certain office surgery and the 40 office in which the surgery is performed to maintain 41 specified levels of financial responsibility; 42 authorizing the Board of Osteopathic Medicine to adopt 43 rules to administer the registration, inspection, and 44 safety of offices that perform certain office surgery; 45 requiring such an office to designate a certain 46 physician responsible for the office’s compliance with 47 specified provisions; authorizing the department to 48 suspend an office’s registration certificate under 49 certain circumstances; requiring the department to 50 conduct certain inspections; providing an exception; 51 requiring the board to adopt rules governing the 52 standard of care for physicians practicing in such 53 offices; requiring the board to impose a specified 54 fine on physicians who perform certain office 55 surgeries in an unregistered office; amending s. 56 459.015, F.S.; providing that a physician performing 57 certain office surgeries in an unregistered office 58 constitutes grounds for denial of a license or 59 disciplinary action; amending s. 766.101, F.S.; 60 conforming a cross-reference; providing an effective 61 date. 62 63 Be It Enacted by the Legislature of the State of Florida: 64 65 Section 1. Subsection (12) is added to section 456.004, 66 Florida Statutes, to read: 67 456.004 Department; powers and duties.—The department, for 68 the professions under its jurisdiction, shall: 69 (12) Deny or revoke the registration of, or impose any 70 penalty set forth in s. 456.072(2) against, any facility where 71 office surgery, as defined in ss. 458.305(8) and 459.003(9), is 72 performed for failure of any of its physicians, owners, or 73 operators to comply with rules adopted under ss. 458.309(3) and 74 459.005(2). Section 456.073 applies to enforcement actions 75 brought against such facilities. If a facility’s registration is 76 revoked, the department may deny any person named in the 77 registration documents of the facility, including the persons 78 who own or operate the facility, individually or as part of a 79 group, from registering a facility to perform surgical 80 procedures pursuant to s. 458.309(3) or s. 459.005(2) for 5 81 years after the revocation date. 82 Section 2. Subsection (6) is added to section 456.074, 83 Florida Statutes, to read: 84 456.074 Certain health care practitioners; immediate 85 suspension of license.— 86 (6) The department may issue an emergency order suspending 87 or restricting the registration of a facility in which 88 liposuction procedures in which more than 1,000 cubic 89 centimeters of supernatant fat is removed, Level II office 90 surgery, or Level III office surgery as those terms are defined 91 in ss. 458.305(8) and 459.003(9), are performed upon a finding 92 of probable cause that the facility or its surgeons are not in 93 compliance with the standards of practice for office surgery 94 adopted by the boards pursuant to s. 458.309(4) or s. 95 459.005(3), as applicable, or are in violation of s. 96 458.331(1)(v) or s. 459.015(1)(z) and that such noncompliance 97 constitutes an immediate danger to the public. 98 Section 3. Section 458.305, Florida Statutes, is amended to 99 read: 100 458.305 Definitions.—As used in this chapter, the term: 101 (1) “Board” means the Board of Medicine. 102 (2) “Deep sedation and analgesia” means a drug-induced 103 depression of consciousness during which all of the following 104 apply: 105 (a) The patient cannot be easily aroused but responds by 106 purposefully following repeated or painful stimulation. 107 (b) The patient’s ability to independently maintain 108 ventilatory function may be impaired. 109 (c) The patient may require assistance in maintaining a 110 patent airway, and spontaneous ventilation may be inadequate. 111 (d) The patient’s cardiovascular function is usually 112 maintained. 113 (e) The patient’s reflex withdrawal from painful stimulus 114 is not considered a purposeful response. 115 (3)(2)“Department” means the Department of Health. 116 (4) “Epidural anesthesia” means anesthesia produced by the 117 injection of an anesthetic agent into the space on or around the 118 dura mater of the spinal cord. 119 (5) “General anesthesia” means a drug-induced loss of 120 consciousness administered by a qualified general anesthesia 121 provider during which all of the following apply: 122 (a) The patient is not able to be aroused, even by painful 123 stimulation. 124 (b) The patient’s ability to independently maintain 125 ventilatory function is often impaired. 126 (c) The patient has a level of depressed neuromuscular 127 function. 128 (d) The patient may require assistance in maintaining a 129 patent airway, and positive pressure ventilation may be 130 required. 131 (e) The patient’s cardiovascular function may be impaired. 132 (6) “Minimal sedation” means a drug-induced state during 133 which patients respond normally to verbal commands. Although 134 cognitive function and physical coordination may be impaired, 135 airway reflexes and respiratory and cardiovascular functions are 136 unaffected. 137 (7) “Moderate sedation and analgesia” or “conscious 138 sedation” means drug-induced depression of consciousness and a 139 state of consciousness during which all of the following apply: 140 (a) The patient responds purposefully to verbal commands, 141 either alone or accompanied by light tactile stimulation. 142 (b) Interventions are not required to maintain a patent 143 airway, and spontaneous ventilation is adequate. 144 (c) Cardiovascular function is maintained. 145 (d) Reflex withdrawal from a painful stimulus is not 146 considered a purposeful response. 147 (8) “Office surgery” means a surgery that is performed in a 148 physician’s office or any facility that is not licensed under 149 chapter 390 or chapter 395. 150 (a) “Level I office surgery” includes any surgery that 151 consists of only minor procedures and in which anesthesia is 152 limited to minimal sedation. 153 (b) “Level II office surgery” includes any surgery in which 154 the patient’s level of sedation is that of moderate sedation and 155 analgesia or conscious sedation. 156 (c) ”Level III office surgery” includes any surgery in 157 which the patient’s level of sedation is that of deep sedation 158 and analgesia or general anesthesia. The term includes any 159 surgery that includes the use of spinal anesthesia or epidural 160 anesthesia. 161 (10)(3)“Practice of medicine” means the diagnosis, 162 treatment, operation, or prescription for any human disease, 163 pain, injury, deformity, or other physical or mental condition. 164 (11) “Spinal anesthesia” means anesthesia produced by the 165 injection of an anesthetic agent into the subarachnoid space of 166 the spinal cord. 167 (12) “Surgeon” means a physician who performs surgery. 168 (13) “Surgery” means any manual or operative procedure, 169 including the use of lasers, performed upon the body of a living 170 human being for the purposes of preserving health, diagnosing or 171 curing disease, repairing injury, correcting deformity or 172 defects, prolonging life, or relieving suffering or any elective 173 procedure for aesthetic, reconstructive, or cosmetic purposes, 174 including, but not limited to: incision or curettage of tissue 175 or an organ; suture or other repair of tissue or organ, 176 including a closed as well as an open reduction of a fracture; 177 extraction of tissue including premature extraction of the 178 products of conception from the uterus; insertion of natural or 179 artificial implants; or an endoscopic procedure with use of 180 local or general anesthetic. 181 (9)(4)“Physician” means a person who is licensed to 182 practice medicine in this state. 183 Section 4. Subsection (3) of section 458.309, Florida 184 Statutes, is amended and subsection (4) is added to that 185 section, to read: 186 458.309 Rulemaking authority.— 187 (3) A physician who performs any liposuction procedure 188proceduresin which more than 1,000 cubic centimeters of 189 supernatant fat is removed, any Level II office surgerylevel 2190procedureslasting more than 5 minutes, or any Level III office 191 surgeryandall level 3 surgical proceduresin an office setting 192 must register the office with the department unless that office 193 is licensed as a facility under chapter 395. The department 194 shall inspect the physician’s office annually unless the office 195 is accredited by a nationally recognized accrediting agency or 196 an accrediting organizationsubsequentlyapproved by the Board 197 of Medicine. The actual costs for registration and inspection or 198 accreditation shall be paid by the person seeking to register 199 and operate the office setting in which office surgery is 200 performed. As a condition of registration, a physician who 201 performs such surgical procedures in an office setting, and the 202 office itself if it is a separate legal entity from the 203 physician, must maintain the same levels of financial 204 responsibility required in s. 458.320. 205 (4)(a) The board may adopt rules to administer the 206 registration, inspection, and safety of offices in which a 207 physician performs office surgery. 208 (b) As a part of registration, such an office must 209 designate a physician who is responsible for the office’s 210 compliance with this section and the rules adopted hereunder. 211 Within 10 days after termination of the designated physician, 212 the office must notify the department of the identity of another 213 designated physician for that office. The designated physician 214 must have a full, active, and unencumbered license under this 215 chapter or chapter 459 and shall practice at the office for 216 which he or she has assumed responsibility. The department may 217 suspend a registration certificate for an office without a 218 designated physician who practices at the office. 219 (c) The department shall inspect the office at least 220 annually, including a review of patient records, to ensure that 221 it complies with this section and rules adopted hereunder unless 222 the office is accredited by a nationally recognized accrediting 223 agency approved by the board. The inspection may be unannounced, 224 except for the inspection of a physician’s office that meets the 225 description of a clinic specified in s. 458.3265(1)(a)3.g. and 226 h., which must be announced. 227 (d) The board shall adopt by rule standards of practice for 228 physicians who perform office surgery. The board shall impose a 229 fine of $5,000 per day on a physician who performs a surgical 230 procedure identified in subsection (3) in an office that is not 231 registered with the department. 232 Section 5. Paragraph (vv) is added to subsection (1) of 233 section 458.331, Florida Statutes, to read: 234 458.331 Grounds for disciplinary action; action by the 235 board and department.— 236 (1) The following acts constitute grounds for denial of a 237 license or disciplinary action, as specified in s. 456.072(2): 238 (vv) Performing a liposuction procedure in which more than 239 1,000 cubic centimeters of supernatant fat is removed, a Level 240 II office surgery, or a Level III office surgery in an office 241 that is not registered with the department pursuant to s. 242 458.309(3). 243 Section 6. Section 459.003, Florida Statutes, is amended to 244 read: 245 459.003 Definitions.—As used in this chapter, the term: 246 (1) “Board” means the Board of Osteopathic Medicine. 247 (2) “Deep sedation and analgesia” means a drug-induced 248 depression of consciousness during which all of the following 249 apply: 250 (a) The patient cannot be easily aroused but responds by 251 purposefully following repeated or painful stimulation. 252 (b) The patient’s ability to independently maintain 253 ventilatory function may be impaired. 254 (c) The patient may require assistance in maintaining a 255 patent airway, and spontaneous ventilation may be inadequate. 256 (d) The patient’s cardiovascular function is usually 257 maintained. 258 (e) The patient’s reflex withdrawal from painful stimulus 259 is not considered a purposeful response. 260 (3)(2)“Department” means the Department of Health. 261 (5) “Epidural anesthesia” means anesthesia produced by the 262 injection of an anesthetic agent into the space on or around the 263 dura mater of the spinal cord. 264 (6) “General anesthesia” means a drug-induced loss of 265 consciousness administered by a qualified general anesthesia 266 provider during which all of the following apply: 267 (a) The patient is not able to be aroused, even by painful 268 stimulation. 269 (b) The patient’s ability to independently maintain 270 ventilatory function is often impaired. 271 (c) The patient has a level of depressed neuromuscular 272 function. 273 (d) The patient may require assistance in maintaining a 274 patent airway, and positive pressure ventilation may be 275 required. 276 (e) The patient’s cardiovascular function may be impaired. 277 (7) “Minimal sedation” means a drug-induced state during 278 which patients respond normally to verbal commands. Although 279 cognitive function and physical coordination may be impaired, 280 airway reflexes, and respiratory and cardiovascular functions 281 are unaffected. 282 (8) “Moderate sedation and analgesia” or “conscious 283 sedation” means drug-induced depression of consciousness and a 284 state of consciousness during which all of the following apply: 285 (a) The patient responds purposefully to verbal commands, 286 either alone or accompanied by light tactile stimulation. 287 (b) Interventions are not required to maintain a patent 288 airway, and spontaneous ventilation is adequate. 289 (c) Cardiovascular function is maintained. 290 (d) Reflex withdrawal from a painful stimulus is not 291 considered a purposeful response. 292 (9) “Office surgery” means a surgery that is performed in a 293 physician’s office or any facility that is not licensed under 294 chapter 390 or chapter 395. 295 (a) “Level I office surgery” includes any surgery that 296 consists of only minor procedures and in which anesthesia is 297 limited to minimal sedation. 298 (b) “Level II office surgery” includes any surgery in which 299 the patient’s level of sedation is that of moderate sedation and 300 analgesia or conscious sedation. 301 (c) ”Level III office surgery” includes any surgery in 302 which the patient’s level of sedation is that of deep sedation 303 and analgesia or general anesthesia. The term includes any 304 surgery that includes the use of spinal anesthesia or epidural 305 anesthesia. 306 (11)(3)“Practice of osteopathic medicine” means the 307 diagnosis, treatment, operation, or prescription for any human 308 disease, pain, injury, deformity, or other physical or mental 309 condition, which practice is based in part upon educational 310 standards and requirements which emphasize the importance of the 311 musculoskeletal structure and manipulative therapy in the 312 maintenance and restoration of health. 313 (12) “Spinal anesthesia” means anesthesia produced by the 314 injection of an anesthetic agent into the subarachnoid space of 315 the spinal cord. 316 (13) “Surgeon” means a physician who performs surgery. 317 (14) “Surgery” means any manual or operative procedure, 318 including the use of lasers, performed upon the body of a living 319 human being for the purposes of preserving health, diagnosing or 320 curing disease, repairing injury, correcting deformity or 321 defects, prolonging life, or relieving suffering or any elective 322 procedure for aesthetic, reconstructive, or cosmetic purposes, 323 including, but not limited to: incision or curettage of tissue 324 or an organ; suture or other repair of tissue or organ, 325 including a closed as well as an open reduction of a fracture; 326 extraction of tissue including premature extraction of the 327 products of conception from the uterus; insertion of natural or 328 artificial implants; or an endoscopic procedure with use of 329 local or general anesthetic. 330 (10)(4)“Osteopathic physician” means a person who is 331 licensed to practice osteopathic medicine in this state. 332 (4)(5)“Doctor of Osteopathy” and “Doctor of Osteopathic 333 Medicine,” when referring to degrees, shall be construed to be 334 equivalent and equal degrees. 335 Section 7. Subsection (2) of section 459.005, Florida 336 Statutes, is amended and subsection (3) is added to that 337 section, to read: 338 459.005 Rulemaking authority.— 339 (2) A physician who performs any liposuction procedure 340proceduresin which more than 1,000 cubic centimeters of 341 supernatant fat is removed, any Level II office surgerylevel 2342procedures lasting more than 5 minutes, or any Level III office 343 surgeryand all level 3 surgical proceduresin an office setting 344 must register the office with the department unless that office 345 is licensed as a facility under chapter 395. The department 346 shall inspect the physician’s office annually unless the office 347 is accredited by a nationally recognized accrediting agency or 348 an accrediting organizationsubsequentlyapproved by the Board 349 of Osteopathic Medicine. The actual costs for registration and 350 inspection or accreditation shall be paid by the person seeking 351 to register and operate the office setting in which office 352 surgery is performed. As a condition of registration, a 353 physician who performs such surgical procedures in an office 354 setting, and the office itself if it is a separate legal entity 355 from the physician, must maintain the same levels of financial 356 responsibility required in s. 459.0085. 357 (3)(a) The board may adopt rules to administer the 358 registration, inspection, and safety of offices in which a 359 physician performs office surgery. 360 (b) As a part of registration, such an office must 361 designate a physician who is responsible for the office’s 362 compliance with this section and the rules adopted hereunder. 363 Within 10 days after termination of the designated physician, 364 the office must notify the department of the identity of another 365 designated physician for that office. The designated physician 366 must have a full, active, and unencumbered license under this 367 chapter or chapter 458 and shall practice at the office for 368 which he or she has assumed responsibility. The department may 369 suspend a registration certificate for an office without a 370 designated physician who practices at the office. 371 (c) The department shall inspect the office at least 372 annually, including a review of patient records, to ensure that 373 it complies with this section and rules adopted hereunder unless 374 the office is accredited by a nationally recognized accrediting 375 agency approved by the board. The inspection may be unannounced, 376 except for the inspection of a physician’s office that meets the 377 description of a clinic specified in s. 459.0137(1)(a)3.g. and 378 h., which must be announced. 379 (d) The board shall adopt by rule standards of practice for 380 physicians who perform office surgery. The board shall impose a 381 fine of $5,000 per day on a physician who performs a surgical 382 procedure identified in subsection (2) in an office that is not 383 registered with the department. 384 Section 8. Paragraph (xx) is added to subsection (1) of 385 section 459.015, Florida Statutes, to read: 386 459.015 Grounds for disciplinary action; action by the 387 board and department.— 388 (1) The following acts constitute grounds for denial of a 389 license or disciplinary action, as specified in s. 456.072(2): 390 (xx) Performing a liposuction procedure in which more than 391 1,000 cubic centimeters of supernatant fat is removed, a Level 392 II office surgery, or a Level III office surgery in an office 393 that is not registered with the department pursuant to s. 394 459.005(2). 395 Section 9. Paragraph (a) of subsection (1) of section 396 766.101, Florida Statutes, is amended to read: 397 766.101 Medical review committee, immunity from liability.— 398 (1) As used in this section: 399 (a) The term “medical review committee” or “committee” 400 means: 401 1.a. A committee of a hospital or ambulatory surgical 402 center licensed under chapter 395 or a health maintenance 403 organization certificated under part I of chapter 641; 404 b. A committee of a physician-hospital organization, a 405 provider-sponsored organization, or an integrated delivery 406 system; 407 c. A committee of a state or local professional society of 408 health care providers; 409 d. A committee of a medical staff of a licensed hospital or 410 nursing home, provided the medical staff operates pursuant to 411 written bylaws that have been approved by the governing board of 412 the hospital or nursing home; 413 e. A committee of the Department of Corrections or the 414 Correctional Medical Authority as created under s. 945.602, or 415 employees, agents, or consultants of either the department or 416 the authority or both; 417 f. A committee of a professional service corporation formed 418 under chapter 621 or a corporation organized under part I of 419 chapter 607 or chapter 617, which is formed and operated for the 420 practice of medicine as defined in s. 458.305s. 458.305(3), and 421 which has at least 25 health care providers who routinely 422 provide health care services directly to patients; 423 g. A committee of the Department of Children and Families 424 which includes employees, agents, or consultants to the 425 department as deemed necessary to provide peer review, 426 utilization review, and mortality review of treatment services 427 provided pursuant to chapters 394, 397, and 916; 428 h. A committee of a mental health treatment facility 429 licensed under chapter 394 or a community mental health center 430 as defined in s. 394.907, provided the quality assurance program 431 operates pursuant to the guidelines that have been approved by 432 the governing board of the agency; 433 i. A committee of a substance abuse treatment and education 434 prevention program licensed under chapter 397 provided the 435 quality assurance program operates pursuant to the guidelines 436 that have been approved by the governing board of the agency; 437 j. A peer review or utilization review committee organized 438 under chapter 440; 439 k. A committee of the Department of Health, a county health 440 department, healthy start coalition, or certified rural health 441 network, when reviewing quality of care, or employees of these 442 entities when reviewing mortality records; or 443 l. A continuous quality improvement committee of a pharmacy 444 licensed pursuant to chapter 465, 445 446 which committee is formed to evaluate and improve the quality of 447 health care rendered by providers of health service, to 448 determine that health services rendered were professionally 449 indicated or were performed in compliance with the applicable 450 standard of care, or that the cost of health care rendered was 451 considered reasonable by the providers of professional health 452 services in the area; or 453 2. A committee of an insurer, self-insurer, or joint 454 underwriting association of medical malpractice insurance, or 455 other persons conducting review under s. 766.106. 456 Section 10. This act shall take effect upon becoming a law.