Florida Senate - 2019                        COMMITTEE AMENDMENT
       Bill No. CS for SB 732
       
       
       
       
       
       
                                Ì978476[Î978476                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/10/2019           .                                
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       Appropriations Subcommittee on Health and Human Services
       (Flores) recommended the following:
       
    1         Senate Substitute for Amendment (359744) (with title
    2  amendment)
    3  
    4         Delete everything after the enacting clause
    5  and insert:
    6         Section 1. Subsection (12) is added to section 456.004,
    7  Florida Statutes, to read:
    8         456.004 Department; powers and duties.—The department, for
    9  the professions under its jurisdiction, shall:
   10         (12) Deny or revoke the registration of, or impose any
   11  penalty set forth in s. 456.072(2) against, any facility where
   12  office surgery, as defined in ss. 458.305(8) and 459.003(9), is
   13  performed for failure of any of its physicians, owners, or
   14  operators to comply with rules adopted under ss. 458.309(3) and
   15  459.005(2). Section 456.073 applies to enforcement actions
   16  brought against such facilities. If a facility’s registration is
   17  revoked, the department may deny any person named in the
   18  registration documents of the facility, including the persons
   19  who own or operate the facility, individually or as part of a
   20  group, from registering a facility to perform surgical
   21  procedures pursuant to s. 458.309(3) or s. 459.005(2) for 5
   22  years after the revocation date.
   23         Section 2. Subsection (6) is added to section 456.074,
   24  Florida Statutes, to read:
   25         456.074 Certain health care practitioners; immediate
   26  suspension of license.—
   27         (6) The department may issue an emergency order suspending
   28  or restricting the registration of a facility in which
   29  liposuction procedures in which more than 1,000 cubic
   30  centimeters of supernatant fat is removed, Level II office
   31  surgery, or Level III office surgery as those terms are defined
   32  in ss. 458.305(8) and 459.003(9), are performed upon a finding
   33  of probable cause that the facility or its surgeons are not in
   34  compliance with the standards of practice for office surgery
   35  adopted by the boards pursuant to s. 458.309(4) or s.
   36  459.005(3), as applicable, or are in violation of s.
   37  458.331(1)(v) or s. 459.015(1)(z) and that such noncompliance
   38  constitutes an immediate danger to the public.
   39         Section 3. Section 458.305, Florida Statutes, is amended to
   40  read:
   41         458.305 Definitions.—As used in this chapter, the term:
   42         (1) “Board” means the Board of Medicine.
   43         (2)“Deep sedation and analgesia” means a drug-induced
   44  depression of consciousness during which all of the following
   45  apply:
   46         (a) The patient cannot be easily aroused but responds by
   47  purposefully following repeated or painful stimulation.
   48         (b) The patient’s ability to independently maintain
   49  ventilatory function may be impaired.
   50         (c) The patient may require assistance in maintaining a
   51  patent airway, and spontaneous ventilation may be inadequate.
   52         (d) The patient’s cardiovascular function is usually
   53  maintained.
   54         (e) The patient’s reflex withdrawal from painful stimulus
   55  is not considered a purposeful response.
   56         (3)(2) “Department” means the Department of Health.
   57         (4)“Epidural anesthesia” means anesthesia produced by the
   58  injection of an anesthetic agent into the space on or around the
   59  dura mater of the spinal cord.
   60         (5)“General anesthesia” means a drug-induced loss of
   61  consciousness administered by a qualified general anesthesia
   62  provider during which all of the following apply:
   63         (a) The patient is not able to be aroused, even by painful
   64  stimulation.
   65         (b) The patient’s ability to independently maintain
   66  ventilatory function is often impaired.
   67         (c) The patient has a level of depressed neuromuscular
   68  function.
   69         (d) The patient may require assistance in maintaining a
   70  patent airway, and positive pressure ventilation may be
   71  required.
   72         (e) The patient’s cardiovascular function may be impaired.
   73         (6)“Minimal sedation” means a drug-induced state during
   74  which patients respond normally to verbal commands. Although
   75  cognitive function and physical coordination may be impaired,
   76  airway reflexes and respiratory and cardiovascular functions are
   77  unaffected.
   78         (7) “Moderate sedation and analgesia” or “conscious
   79  sedation” means drug-induced depression of consciousness and a
   80  state of consciousness during which all of the following apply:
   81         (a) The patient responds purposefully to verbal commands,
   82  either alone or accompanied by light tactile stimulation.
   83         (b) Interventions are not required to maintain a patent
   84  airway, and spontaneous ventilation is adequate.
   85         (c) Cardiovascular function is maintained.
   86         (d) Reflex withdrawal from a painful stimulus is not
   87  considered a purposeful response.
   88         (8)“Office surgery” means a surgery that is performed in a
   89  physician’s office or any facility that is not licensed under
   90  chapter 390 or chapter 395.
   91         (a)“Level I office surgery” includes any surgery that
   92  consists of only minor procedures and in which anesthesia is
   93  limited to minimal sedation.
   94         (b)“Level II office surgery includes any surgery in which
   95  the patient’s level of sedation is that of moderate sedation and
   96  analgesia or conscious sedation.
   97         (c) ”Level III office surgery includes any surgery in
   98  which the patient’s level of sedation is that of deep sedation
   99  and analgesia or general anesthesia. The term includes any
  100  surgery that includes the use of spinal anesthesia or epidural
  101  anesthesia.
  102         (10)(3) “Practice of medicine” means the diagnosis,
  103  treatment, operation, or prescription for any human disease,
  104  pain, injury, deformity, or other physical or mental condition.
  105         (11)“Spinal anesthesia” means anesthesia produced by the
  106  injection of an anesthetic agent into the subarachnoid space of
  107  the spinal cord.
  108         (12)“Surgeon” means a physician who performs surgery.
  109         (13)“Surgery” means any manual or operative procedure,
  110  including the use of lasers, performed upon the body of a living
  111  human being for the purposes of preserving health, diagnosing or
  112  curing disease, repairing injury, correcting deformity or
  113  defects, prolonging life, or relieving suffering or any elective
  114  procedure for aesthetic, reconstructive, or cosmetic purposes,
  115  including, but not limited to: incision or curettage of tissue
  116  or an organ; suture or other repair of tissue or organ,
  117  including a closed as well as an open reduction of a fracture;
  118  extraction of tissue including premature extraction of the
  119  products of conception from the uterus; insertion of natural or
  120  artificial implants; or an endoscopic procedure with use of
  121  local or general anesthetic.
  122         (9)(4) “Physician” means a person who is licensed to
  123  practice medicine in this state.
  124         Section 4. Subsection (3) of section 458.309, Florida
  125  Statutes, is amended and subsection (4) is added to that
  126  section, to read:
  127         458.309 Rulemaking authority.—
  128         (3) A physician who performs any liposuction procedure
  129  procedures in which more than 1,000 cubic centimeters of
  130  supernatant fat is removed, any Level II office surgery level 2
  131  procedures lasting more than 5 minutes, or any Level III office
  132  surgery and all level 3 surgical procedures in an office setting
  133  must register the office with the department unless that office
  134  is licensed as a facility under chapter 395. The department
  135  shall inspect the physician’s office annually unless the office
  136  is accredited by a nationally recognized accrediting agency or
  137  an accrediting organization subsequently approved by the Board
  138  of Medicine. The actual costs for registration and inspection or
  139  accreditation shall be paid by the person seeking to register
  140  and operate the office setting in which office surgery is
  141  performed. As a condition of registration, a physician who
  142  performs such surgical procedures in an office setting, and the
  143  office itself if it is a separate legal entity from the
  144  physician, must maintain the same levels of financial
  145  responsibility required in s. 458.320.
  146         (4)(a) The board may adopt rules to administer the
  147  registration, inspection, and safety of offices in which a
  148  physician performs office surgery.
  149         (b)As a part of registration, such an office must
  150  designate a physician who is responsible for the office’s
  151  compliance with this section and the rules adopted hereunder.
  152  Within 10 days after termination of the designated physician,
  153  the office must notify the department of the identity of another
  154  designated physician for that office. The designated physician
  155  must have a full, active, and unencumbered license under this
  156  chapter or chapter 459 and shall practice at the office for
  157  which he or she has assumed responsibility. The department may
  158  suspend a registration certificate for an office without a
  159  designated physician who practices at the office.
  160         (c) The department shall inspect the office at least
  161  annually, including a review of patient records, to ensure that
  162  it complies with this section and rules adopted hereunder unless
  163  the office is accredited by a nationally recognized accrediting
  164  agency approved by the board. The inspection may be unannounced,
  165  except for the inspection of a physician’s office that meets the
  166  description of a clinic specified in s. 458.3265(1)(a)1.h.,
  167  which must be announced.
  168         (d) The board shall adopt by rule standards of practice for
  169  physicians who perform office surgery. The board shall impose a
  170  fine of $5,000 per day on a physician who performs a surgical
  171  procedure identified in subsection (3) in an office that is not
  172  registered with the department.
  173         Section 5. Paragraph (vv) is added to subsection (1) of
  174  section 458.331, Florida Statutes, to read:
  175         458.331 Grounds for disciplinary action; action by the
  176  board and department.—
  177         (1) The following acts constitute grounds for denial of a
  178  license or disciplinary action, as specified in s. 456.072(2):
  179         (vv) Performing a liposuction procedure in which more than
  180  1,000 cubic centimeters of supernatant fat is removed, a Level
  181  II office surgery, or a Level III office surgery in an office
  182  that is not registered with the department pursuant to s.
  183  458.309(3).
  184         Section 6. Section 459.003, Florida Statutes, is amended to
  185  read:
  186         459.003 Definitions.—As used in this chapter, the term:
  187         (1) “Board” means the Board of Osteopathic Medicine.
  188         (2)“Deep sedation and analgesia” means a drug-induced
  189  depression of consciousness during which all of the following
  190  apply:
  191         (a) The patient cannot be easily aroused but responds by
  192  purposefully following repeated or painful stimulation.
  193         (b) The patient’s ability to independently maintain
  194  ventilatory function may be impaired.
  195         (c) The patient may require assistance in maintaining a
  196  patent airway, and spontaneous ventilation may be inadequate.
  197         (d) The patient’s cardiovascular function is usually
  198  maintained.
  199         (e) The patient’s reflex withdrawal from painful stimulus
  200  is not considered a purposeful response.
  201         (3)(2) “Department” means the Department of Health.
  202         (5)“Epidural anesthesia” means anesthesia produced by the
  203  injection of an anesthetic agent into the space on or around the
  204  dura mater of the spinal cord.
  205         (6)“General anesthesia” means a drug-induced loss of
  206  consciousness administered by a qualified general anesthesia
  207  provider during which all of the following apply:
  208         (a) The patient is not able to be aroused, even by painful
  209  stimulation.
  210         (b) The patient’s ability to independently maintain
  211  ventilatory function is often impaired.
  212         (c) The patient has a level of depressed neuromuscular
  213  function.
  214         (d) The patient may require assistance in maintaining a
  215  patent airway, and positive pressure ventilation may be
  216  required.
  217         (e) The patient’s cardiovascular function may be impaired.
  218         (7)“Minimal sedation” means a drug-induced state during
  219  which patients respond normally to verbal commands. Although
  220  cognitive function and physical coordination may be impaired,
  221  airway reflexes, and respiratory and cardiovascular functions
  222  are unaffected.
  223         (8) “Moderate sedation and analgesia” or “conscious
  224  sedation” means drug-induced depression of consciousness and a
  225  state of consciousness during which all of the following apply:
  226         (a) The patient responds purposefully to verbal commands,
  227  either alone or accompanied by light tactile stimulation.
  228         (b) Interventions are not required to maintain a patent
  229  airway, and spontaneous ventilation is adequate.
  230         (c) Cardiovascular function is maintained.
  231         (d) Reflex withdrawal from a painful stimulus is not
  232  considered a purposeful response.
  233         (9)“Office surgery” means a surgery that is performed in a
  234  physician’s office or any facility that is not licensed under
  235  chapter 390 or chapter 395.
  236         (a)“Level I office surgery” includes any surgery that
  237  consists of only minor procedures and in which anesthesia is
  238  limited to minimal sedation.
  239         (b)“Level II office surgery” includes any surgery in which
  240  the patient’s level of sedation is that of moderate sedation and
  241  analgesia or conscious sedation.
  242         (c) ”Level III office surgery” includes any surgery in
  243  which the patient’s level of sedation is that of deep sedation
  244  and analgesia or general anesthesia. The term includes any
  245  surgery that includes the use of spinal anesthesia or epidural
  246  anesthesia.
  247         (11)(3) “Practice of osteopathic medicine” means the
  248  diagnosis, treatment, operation, or prescription for any human
  249  disease, pain, injury, deformity, or other physical or mental
  250  condition, which practice is based in part upon educational
  251  standards and requirements which emphasize the importance of the
  252  musculoskeletal structure and manipulative therapy in the
  253  maintenance and restoration of health.
  254         (12)“Spinal anesthesia” means anesthesia produced by the
  255  injection of an anesthetic agent into the subarachnoid space of
  256  the spinal cord.
  257         (13)“Surgeon” means a physician who performs surgery.
  258         (14)“Surgery” means any manual or operative procedure,
  259  including the use of lasers, performed upon the body of a living
  260  human being for the purposes of preserving health, diagnosing or
  261  curing disease, repairing injury, correcting deformity or
  262  defects, prolonging life, or relieving suffering or any elective
  263  procedure for aesthetic, reconstructive, or cosmetic purposes,
  264  including, but not limited to: incision or curettage of tissue
  265  or an organ; suture or other repair of tissue or organ,
  266  including a closed as well as an open reduction of a fracture;
  267  extraction of tissue including premature extraction of the
  268  products of conception from the uterus; insertion of natural or
  269  artificial implants; or an endoscopic procedure with use of
  270  local or general anesthetic.
  271         (10)(4) “Osteopathic physician” means a person who is
  272  licensed to practice osteopathic medicine in this state.
  273         (4)(5) “Doctor of Osteopathy” and “Doctor of Osteopathic
  274  Medicine,” when referring to degrees, shall be construed to be
  275  equivalent and equal degrees.
  276         Section 7. Subsection (2) of section 459.005, Florida
  277  Statutes, is amended and subsection (3) is added to that
  278  section, to read:
  279         459.005 Rulemaking authority.—
  280         (2) A physician who performs any liposuction procedure
  281  procedures in which more than 1,000 cubic centimeters of
  282  supernatant fat is removed, any Level II office surgery level 2
  283  procedures lasting more than 5 minutes, or any Level III office
  284  surgery and all level 3 surgical procedures in an office setting
  285  must register the office with the department unless that office
  286  is licensed as a facility under chapter 395. The department
  287  shall inspect the physician’s office annually unless the office
  288  is accredited by a nationally recognized accrediting agency or
  289  an accrediting organization subsequently approved by the Board
  290  of Osteopathic Medicine. The actual costs for registration and
  291  inspection or accreditation shall be paid by the person seeking
  292  to register and operate the office setting in which office
  293  surgery is performed. As a condition of registration, a
  294  physician who performs such surgical procedures in an office
  295  setting, and the office itself if it is a separate legal entity
  296  from the physician, must maintain the same levels of financial
  297  responsibility required in s. 459.0085.
  298         (3)(a) The board may adopt rules to administer the
  299  registration, inspection, and safety of offices in which a
  300  physician performs office surgery.
  301         (b)As a part of registration, such an office must
  302  designate a physician who is responsible for the office’s
  303  compliance with this section and the rules adopted hereunder.
  304  Within 10 days after termination of the designated physician,
  305  the office must notify the department of the identity of another
  306  designated physician for that office. The designated physician
  307  must have a full, active, and unencumbered license under this
  308  chapter or chapter 458 and shall practice at the office for
  309  which he or she has assumed responsibility. The department may
  310  suspend a registration certificate for an office without a
  311  designated physician who practices at the office.
  312         (c) The department shall inspect the office at least
  313  annually, including a review of patient records, to ensure that
  314  it complies with this section and rules adopted hereunder unless
  315  the office is accredited by a nationally recognized accrediting
  316  agency approved by the board. The inspection may be unannounced,
  317  except for the inspection of a physician’s office that meets the
  318  description of a clinic specified in s. 459.0137(1)(a)1.h.,
  319  which must be announced.
  320         (d) The board shall adopt by rule standards of practice for
  321  physicians who perform office surgery. The board shall impose a
  322  fine of $5,000 per day on a physician who performs a surgical
  323  procedure identified in subsection (2) in an office that is not
  324  registered with the department.
  325         Section 8. Paragraph (xx) is added to subsection (1) of
  326  section 459.015, Florida Statutes, to read:
  327         459.015 Grounds for disciplinary action; action by the
  328  board and department.—
  329         (1) The following acts constitute grounds for denial of a
  330  license or disciplinary action, as specified in s. 456.072(2):
  331         (xx) Performing a liposuction procedure in which more than
  332  1,000 cubic centimeters of supernatant fat is removed, a Level
  333  II office surgery, or a Level III office surgery in an office
  334  that is not registered with the department pursuant to s.
  335  459.005(2).
  336         Section 9. Paragraph (a) of subsection (1) of section
  337  766.101, Florida Statutes, is amended to read:
  338         766.101 Medical review committee, immunity from liability.—
  339         (1) As used in this section:
  340         (a) The term “medical review committee” or “committee”
  341  means:
  342         1.a. A committee of a hospital or ambulatory surgical
  343  center licensed under chapter 395 or a health maintenance
  344  organization certificated under part I of chapter 641;
  345         b. A committee of a physician-hospital organization, a
  346  provider-sponsored organization, or an integrated delivery
  347  system;
  348         c. A committee of a state or local professional society of
  349  health care providers;
  350         d. A committee of a medical staff of a licensed hospital or
  351  nursing home, provided the medical staff operates pursuant to
  352  written bylaws that have been approved by the governing board of
  353  the hospital or nursing home;
  354         e. A committee of the Department of Corrections or the
  355  Correctional Medical Authority as created under s. 945.602, or
  356  employees, agents, or consultants of either the department or
  357  the authority or both;
  358         f. A committee of a professional service corporation formed
  359  under chapter 621 or a corporation organized under part I of
  360  chapter 607 or chapter 617, which is formed and operated for the
  361  practice of medicine as defined in s. 458.305 s. 458.305(3), and
  362  which has at least 25 health care providers who routinely
  363  provide health care services directly to patients;
  364         g. A committee of the Department of Children and Families
  365  which includes employees, agents, or consultants to the
  366  department as deemed necessary to provide peer review,
  367  utilization review, and mortality review of treatment services
  368  provided pursuant to chapters 394, 397, and 916;
  369         h. A committee of a mental health treatment facility
  370  licensed under chapter 394 or a community mental health center
  371  as defined in s. 394.907, provided the quality assurance program
  372  operates pursuant to the guidelines that have been approved by
  373  the governing board of the agency;
  374         i. A committee of a substance abuse treatment and education
  375  prevention program licensed under chapter 397 provided the
  376  quality assurance program operates pursuant to the guidelines
  377  that have been approved by the governing board of the agency;
  378         j. A peer review or utilization review committee organized
  379  under chapter 440;
  380         k. A committee of the Department of Health, a county health
  381  department, healthy start coalition, or certified rural health
  382  network, when reviewing quality of care, or employees of these
  383  entities when reviewing mortality records; or
  384         l. A continuous quality improvement committee of a pharmacy
  385  licensed pursuant to chapter 465,
  386  
  387  which committee is formed to evaluate and improve the quality of
  388  health care rendered by providers of health service, to
  389  determine that health services rendered were professionally
  390  indicated or were performed in compliance with the applicable
  391  standard of care, or that the cost of health care rendered was
  392  considered reasonable by the providers of professional health
  393  services in the area; or
  394         2. A committee of an insurer, self-insurer, or joint
  395  underwriting association of medical malpractice insurance, or
  396  other persons conducting review under s. 766.106.
  397         Section 10. This act shall take effect upon becoming a law.
  398  
  399  ================= T I T L E  A M E N D M E N T ================
  400  And the title is amended as follows:
  401         Delete everything before the enacting clause
  402  and insert:
  403                        A bill to be entitled                      
  404         An act relating to clinics and office surgery;
  405         amending s. 456.004, F.S.; requiring the Department of
  406         Health to deny or revoke the registration of or impose
  407         certain penalties against a facility where certain
  408         office surgeries are performed under certain
  409         circumstances; specifying provisions that apply
  410         enforcement actions against such facilities;
  411         authorizing the department to deny certain persons
  412         associated with an office of which the registration
  413         was revoked from registering a new office to perform
  414         certain office surgery; amending s. 456.074, F.S.;
  415         authorizing the department to issue an emergency order
  416         suspending or restricting the registration of a
  417         certain office if it makes certain findings; amending
  418         s. 458.305, F.S.; defining terms; amending s. 458.309,
  419         F.S.; requiring a physician who performs certain
  420         office surgery and the office in which the surgery is
  421         performed to maintain specified levels of financial
  422         responsibility; authorizing the Board of Medicine to
  423         adopt rules to administer the registration,
  424         inspection, and safety of offices that perform certain
  425         office surgery; requiring such an office to designate
  426         a certain physician responsible for the office’s
  427         compliance with specified provisions; authorizing the
  428         department to suspend an office’s registration
  429         certificate under certain circumstances; requiring the
  430         department to conduct certain inspections; providing
  431         an exception; requiring the board to adopt rules
  432         governing the standard of care for physicians
  433         practicing in such offices; requiring the board to
  434         impose a specified fine on physicians who perform
  435         certain office surgeries in an unregistered office;
  436         amending s. 458.331, F.S.; providing that a physician
  437         performing certain office surgeries in an unregistered
  438         office constitutes grounds for denial of a license or
  439         disciplinary action; amending s. 459.003, F.S.;
  440         defining terms; amending s. 459.005, F.S.; requiring a
  441         physician who performs certain office surgery and the
  442         office in which the surgery is performed to maintain
  443         specified levels of financial responsibility;
  444         authorizing the Board of Osteopathic Medicine to adopt
  445         rules to administer the registration, inspection, and
  446         safety of offices that perform certain office surgery;
  447         requiring such an office to designate a certain
  448         physician responsible for the office’s compliance with
  449         specified provisions; authorizing the department to
  450         suspend an office’s registration certificate under
  451         certain circumstances; requiring the department to
  452         conduct certain inspections; providing an exception;
  453         requiring the board to adopt rules governing the
  454         standard of care for physicians practicing in such
  455         offices; requiring the board to impose a specified
  456         fine on physicians who perform certain office
  457         surgeries in an unregistered office; amending s.
  458         459.015, F.S.; providing that a physician performing
  459         certain office surgeries in an unregistered office
  460         constitutes grounds for denial of a license or
  461         disciplinary action; amending s. 766.101, F.S.;
  462         conforming a cross-reference; providing an effective
  463         date.