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   11         was revoked from registering a new office to perform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
  188  procedures in which more than 1,000 cubic centimeters of
  189  supernatant fat is removed, any Level II office surgery level 2
  190  procedures lasting more than 5 minutes, or any Level III office
  191  surgery and all level 3 surgical procedures in 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 organization subsequently approved 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
  340  procedures in which more than 1,000 cubic centimeters of
  341  supernatant fat is removed, any Level II office surgery level 2
  342  procedures lasting more than 5 minutes, or any Level III office
  343  surgery and all level 3 surgical procedures in 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 organization subsequently approved 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. 458.305 s. 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.