September 18, 2019
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       Florida Senate - 2010                                     SB 646
       
       
       
       By Senator Aronberg
       
       
       
       
       27-00656B-10                                           2010646__
    1                        A bill to be entitled                      
    2         An act relating to pain-management clinics; amending
    3         ss. 458.309 and 459.005, F.S.; prohibiting a person
    4         from owning or operating a pain-management clinic
    5         unless he or she is a physician licensed in this
    6         state; requiring a physician’s license to be clear and
    7         active to own or operate a pain-management clinic;
    8         providing that a pain-management clinic may not be
    9         owned by or employ a physician who has been
   10         disciplined by the Board of Medicine or the Board of
   11         Osteopathic Medicine for dependency on drugs or
   12         alcohol; providing that a pain-management clinic may
   13         not be owned by or employ a person who has been
   14         convicted of or who has pled guilty or nolo contendere
   15         to a felony; defining the term “controlled substance”;
   16         prohibiting a person from prescribing or dispensing
   17         any medication on the premises of a pain-management
   18         clinic unless he or she is a physician licensed under
   19         ch. 458 or ch. 459, F.S.; providing an exception for a
   20         pharmacist licensed under ch. 465, F.S., to dispense
   21         medications on the premises of a pain-management
   22         clinic; providing an effective date.
   23  
   24  Be It Enacted by the Legislature of the State of Florida:
   25  
   26         Section 1. Subsections (4) and (5) of section 458.309,
   27  Florida Statutes, are amended to read:
   28         458.309 Rulemaking authority.—
   29         (4)(a) All privately owned pain-management clinics,
   30  facilities, or offices, hereinafter referred to as “clinics,”
   31  which advertise in any medium for any type of pain-management
   32  services, or employ a physician who is primarily engaged in the
   33  treatment of pain by prescribing or dispensing controlled
   34  substances substance medications, must register with the
   35  department by January 4, 2010, unless that clinic is licensed as
   36  a facility pursuant to chapter 395. A person may not own or
   37  operate a pain-management clinic in this state unless he or she
   38  is a physician licensed under this chapter or chapter 459. The
   39  status of the physician’s license must be clear and active
   40  according to the Division of Medical Quality Assurance within
   41  the Department of Health in order to own or operate a pain
   42  management clinic. A physician may not practice medicine in a
   43  pain-management clinic that is required to but has not
   44  registered with the department. Each clinic location shall be
   45  registered separately regardless of whether the clinic is
   46  operated under the same business name or management as another
   47  clinic. If the clinic is licensed as a health care clinic under
   48  chapter 400, the medical director is responsible for registering
   49  the facility with the department. If the clinic is not
   50  registered pursuant to chapter 395 or chapter 400, the clinic
   51  shall, upon registration with the department, designate a
   52  physician who is responsible for complying with all requirements
   53  related to registration of the clinic. The designated physician
   54  shall be licensed under this chapter or chapter 459 and shall
   55  practice at the office location for which the physician has
   56  assumed responsibility. The department shall inspect the clinic
   57  annually to ensure that it complies with rules of the Board of
   58  Medicine adopted pursuant to this subsection and subsection (5)
   59  unless the office is accredited by a nationally recognized
   60  accrediting agency approved by the Board of Medicine. The actual
   61  costs for registration and inspection or accreditation shall be
   62  paid by the physician seeking to register the clinic.
   63         (b) A pain-management clinic may not be owned, either in
   64  whole or in part, by or have any contractual relationship,
   65  whether through employment or by independent contract, with:
   66         1. A physician who during the course of his or her practice
   67  has been denied the privilege of prescribing, dispensing,
   68  administering, supplying, or selling any controlled substance
   69  and who has, during the course of his or her practice, had the
   70  board take disciplinary action against his or her medical
   71  license as a result of dependency on drugs or alcohol.
   72         2. A person who has been convicted of or who has pled
   73  guilty or nolo contendere, regardless of whether adjudication
   74  was withheld, to an offense that constitutes a felony.
   75  
   76  As used in this section, the term “controlled substance” means a
   77  controlled substance listed in Schedule II, Schedule III, or
   78  Schedule IV in s. 893.03.
   79         (5) The Board of Medicine shall adopt rules setting forth
   80  standards of practice for physicians practicing in privately
   81  owned pain-management clinics that primarily engage in the
   82  treatment of pain by prescribing or dispensing controlled
   83  substance medications. Such rules shall address, but need not be
   84  limited to, the following subjects:
   85         (a) Facility operations;
   86         (b) Physical operations;
   87         (c) Infection control requirements;
   88         (d) Health and safety requirements;
   89         (e) Quality assurance requirements;
   90         (f) Patient records;
   91         (g) Training requirements for all facility health care
   92  practitioners who are not regulated by another board;
   93         (h) Inspections; and
   94         (i) Data collection and reporting requirements.
   95  
   96  A person may not prescribe or dispense any medication, including
   97  a controlled substance, on the premises of a pain-management
   98  clinic unless he or she is a physician licensed under this
   99  chapter or chapter 459; however, a pharmacist licensed under
  100  chapter 465 may dispense any medication, including a controlled
  101  substance, on the premises of a pain-management clinic. A
  102  physician is primarily engaged in the treatment of pain by
  103  prescribing or dispensing controlled substance medications when
  104  the majority of the patients seen are prescribed or dispensed
  105  controlled substance medications for the treatment of chronic
  106  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  107  to cancer which persists beyond the usual course of the disease
  108  or the injury that is the cause of the pain or more than 90 days
  109  after surgery.
  110         Section 2. Subsections (3) and (4) of section 459.005,
  111  Florida Statutes, are amended to read:
  112         459.005 Rulemaking authority.—
  113         (3)(a) All privately owned pain-management clinics,
  114  facilities, or offices, hereinafter referred to as “clinics,”
  115  which advertise in any medium for any type of pain-management
  116  services, or employ a physician who is licensed under this
  117  chapter and who is primarily engaged in the treatment of pain by
  118  prescribing or dispensing controlled substances substance
  119  medications, must register with the department by January 4,
  120  2010, unless that clinic is licensed as a facility under chapter
  121  395. A person may not own or operate a pain-management clinic in
  122  this state unless he or she is a physician licensed under this
  123  chapter or chapter 458. The status of the physician’s license
  124  must be clear and active according to the Division of Medical
  125  Quality Assurance within the Department of Health in order to
  126  own or operate a pain-management clinic. A physician may not
  127  practice osteopathic medicine in a pain-management clinic that
  128  is required to but has not registered with the department. Each
  129  clinic location shall be registered separately regardless of
  130  whether the clinic is operated under the same business name or
  131  management as another clinic. If the clinic is licensed as a
  132  health care clinic under chapter 400, the medical director is
  133  responsible for registering the facility with the department. If
  134  the clinic is not registered under chapter 395 or chapter 400,
  135  the clinic shall, upon registration with the department,
  136  designate a physician who is responsible for complying with all
  137  requirements related to registration of the clinic. The
  138  designated physician shall be licensed under chapter 458 or this
  139  chapter and shall practice at the office location for which the
  140  physician has assumed responsibility. The department shall
  141  inspect the clinic annually to ensure that it complies with
  142  rules of the Board of Osteopathic Medicine adopted pursuant to
  143  this subsection and subsection (4) unless the office is
  144  accredited by a nationally recognized accrediting agency
  145  approved by the Board of Osteopathic Medicine. The actual costs
  146  for registration and inspection or accreditation shall be paid
  147  by the physician seeking to register the clinic.
  148         (b) A pain-management clinic may not be owned, either in
  149  whole or in part, by or have any contractual relationship,
  150  whether through employment or by independent contract, with:
  151         1. A physician who during the course of his or her practice
  152  has been denied the privilege of prescribing, dispensing,
  153  administering, supplying, or selling any controlled substance
  154  and who has, during the course of his or her practice, had the
  155  board take disciplinary action against his or her medical
  156  license as a result of dependency on drugs or alcohol.
  157         2. A person who has been convicted of or who has pled
  158  guilty or nolo contendere, regardless of whether adjudication
  159  was withheld, to an offense that constitutes a felony.
  160  
  161  As used in this section, the term “controlled substance” means a
  162  controlled substance listed in Schedule II, Schedule III, or
  163  Schedule IV in s. 893.03.
  164         (4) The Board of Osteopathic Medicine shall adopt rules
  165  setting forth standards of practice for physicians who practice
  166  in privately owned pain-management clinics that primarily engage
  167  in the treatment of pain by prescribing or dispensing controlled
  168  substance medications. Such rules shall address, but need not be
  169  limited to, the following subjects:
  170         (a) Facility operations;
  171         (b) Physical operations;
  172         (c) Infection control requirements;
  173         (d) Health and safety requirements;
  174         (e) Quality assurance requirements;
  175         (f) Patient records;
  176         (g) Training requirements for all facility health care
  177  practitioners who are not regulated by another board;
  178         (h) Inspections; and
  179         (i) Data collection and reporting requirements.
  180  
  181  A person may not prescribe or dispense any medication, including
  182  a controlled substance, on the premises of a pain-management
  183  clinic unless he or she is a physician licensed under this
  184  chapter or chapter 458; however, a pharmacist licensed under
  185  chapter 465 may dispense any medication, including a controlled
  186  substance, on the premises of a pain-management clinic. A
  187  physician is primarily engaged in the treatment of pain by
  188  prescribing or dispensing controlled substance medications when
  189  the majority of the patients seen are prescribed or dispensed
  190  controlled substance medications for the treatment of chronic
  191  nonmalignant pain. Chronic nonmalignant pain is pain unrelated
  192  to cancer which persists beyond the usual course of the disease
  193  or the injury that is the cause of the pain or more than 90 days
  194  after surgery.
  195         Section 3. This act shall take effect July 1, 2010.

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