Florida Senate - 2016                          SENATOR AMENDMENT
       Bill No. CS for HB 977
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
               Floor: 1b/RE/2R         .                                
             03/09/2016 06:42 PM       .                                

       Senator Grimsley moved the following:
    1         Senate Amendment to Amendment (510114) (with title
    2  amendment)
    4         Between lines 108 and 109
    5  insert:
    6         Section 4. Paragraph (g) is added to subsection (1) of
    7  section 456.44, Florida Statutes, and subsections (2) and (3) of
    8  that section are amended, to read:
    9         456.44 Controlled substance prescribing.—
   10         (1) DEFINITIONS.—As used in this section, the term:
   11         (g) “Registrant” means a physician who meets the
   12  requirements of subsection (2).
   13         (2) REGISTRATION.—Effective January 1, 2012, A physician
   14  licensed under chapter 458, chapter 459, chapter 461, or chapter
   15  466 who prescribes any controlled substance, listed in Schedule
   16  II, Schedule III, or Schedule IV as defined in s. 893.03, for
   17  the treatment of chronic nonmalignant pain, must:
   18         (a) Designate himself or herself as a controlled substance
   19  prescribing practitioner on his or her the physician’s
   20  practitioner profile.
   21         (b) Comply with the requirements of this section and
   22  applicable board rules.
   23         (3) STANDARDS OF PRACTICE.—The standards of practice in
   24  this section do not supersede the level of care, skill, and
   25  treatment recognized in general law related to health care
   26  licensure.
   27         (a) A complete medical history and a physical examination
   28  must be conducted before beginning any treatment and must be
   29  documented in the medical record. The exact components of the
   30  physical examination shall be left to the judgment of the
   31  registrant clinician who is expected to perform a physical
   32  examination proportionate to the diagnosis that justifies a
   33  treatment. The medical record must, at a minimum, document the
   34  nature and intensity of the pain, current and past treatments
   35  for pain, underlying or coexisting diseases or conditions, the
   36  effect of the pain on physical and psychological function, a
   37  review of previous medical records, previous diagnostic studies,
   38  and history of alcohol and substance abuse. The medical record
   39  shall also document the presence of one or more recognized
   40  medical indications for the use of a controlled substance. Each
   41  registrant must develop a written plan for assessing each
   42  patient’s risk of aberrant drug-related behavior, which may
   43  include patient drug testing. Registrants must assess each
   44  patient’s risk for aberrant drug-related behavior and monitor
   45  that risk on an ongoing basis in accordance with the plan.
   46         (b) Each registrant must develop a written individualized
   47  treatment plan for each patient. The treatment plan shall state
   48  objectives that will be used to determine treatment success,
   49  such as pain relief and improved physical and psychosocial
   50  function, and shall indicate if any further diagnostic
   51  evaluations or other treatments are planned. After treatment
   52  begins, the registrant physician shall adjust drug therapy to
   53  the individual medical needs of each patient. Other treatment
   54  modalities, including a rehabilitation program, shall be
   55  considered depending on the etiology of the pain and the extent
   56  to which the pain is associated with physical and psychosocial
   57  impairment. The interdisciplinary nature of the treatment plan
   58  shall be documented.
   59         (c) The registrant physician shall discuss the risks and
   60  benefits of the use of controlled substances, including the
   61  risks of abuse and addiction, as well as physical dependence and
   62  its consequences, with the patient, persons designated by the
   63  patient, or the patient’s surrogate or guardian if the patient
   64  is incompetent. The registrant physician shall use a written
   65  controlled substance agreement between the registrant physician
   66  and the patient outlining the patient’s responsibilities,
   67  including, but not limited to:
   68         1. Number and frequency of controlled substance
   69  prescriptions and refills.
   70         2. Patient compliance and reasons for which drug therapy
   71  may be discontinued, such as a violation of the agreement.
   72         3. An agreement that controlled substances for the
   73  treatment of chronic nonmalignant pain shall be prescribed by a
   74  single treating registrant physician unless otherwise authorized
   75  by the treating registrant physician and documented in the
   76  medical record.
   77         (d) The patient shall be seen by the registrant physician
   78  at regular intervals, not to exceed 3 months, to assess the
   79  efficacy of treatment, ensure that controlled substance therapy
   80  remains indicated, evaluate the patient’s progress toward
   81  treatment objectives, consider adverse drug effects, and review
   82  the etiology of the pain. Continuation or modification of
   83  therapy shall depend on the registrant’s physician’s evaluation
   84  of the patient’s progress. If treatment goals are not being
   85  achieved, despite medication adjustments, the registrant
   86  physician shall reevaluate the appropriateness of continued
   87  treatment. The registrant physician shall monitor patient
   88  compliance in medication usage, related treatment plans,
   89  controlled substance agreements, and indications of substance
   90  abuse or diversion at a minimum of 3-month intervals.
   91         (e) The registrant physician shall refer the patient as
   92  necessary for additional evaluation and treatment in order to
   93  achieve treatment objectives. Special attention shall be given
   94  to those patients who are at risk for misusing their medications
   95  and those whose living arrangements pose a risk for medication
   96  misuse or diversion. The management of pain in patients with a
   97  history of substance abuse or with a comorbid psychiatric
   98  disorder requires extra care, monitoring, and documentation and
   99  requires consultation with or referral to an addiction medicine
  100  specialist or a psychiatrist.
  101         (f) A registrant physician registered under this section
  102  must maintain accurate, current, and complete records that are
  103  accessible and readily available for review and comply with the
  104  requirements of this section, the applicable practice act, and
  105  applicable board rules. The medical records must include, but
  106  are not limited to:
  107         1. The complete medical history and a physical examination,
  108  including history of drug abuse or dependence.
  109         2. Diagnostic, therapeutic, and laboratory results.
  110         3. Evaluations and consultations.
  111         4. Treatment objectives.
  112         5. Discussion of risks and benefits.
  113         6. Treatments.
  114         7. Medications, including date, type, dosage, and quantity
  115  prescribed.
  116         8. Instructions and agreements.
  117         9. Periodic reviews.
  118         10. Results of any drug testing.
  119         11. A photocopy of the patient’s government-issued photo
  120  identification.
  121         12. If a written prescription for a controlled substance is
  122  given to the patient, a duplicate of the prescription.
  123         13. The registrant’s physician’s full name presented in a
  124  legible manner.
  125         (g) A registrant shall immediately refer patients with
  126  signs or symptoms of substance abuse shall be immediately
  127  referred to a board-certified pain management physician, an
  128  addiction medicine specialist, or a mental health addiction
  129  facility as it pertains to drug abuse or addiction unless the
  130  registrant is a physician who is board-certified or board-
  131  eligible in pain management. Throughout the period of time
  132  before receiving the consultant’s report, a prescribing
  133  registrant physician shall clearly and completely document
  134  medical justification for continued treatment with controlled
  135  substances and those steps taken to ensure medically appropriate
  136  use of controlled substances by the patient. Upon receipt of the
  137  consultant’s written report, the prescribing registrant
  138  physician shall incorporate the consultant’s recommendations for
  139  continuing, modifying, or discontinuing controlled substance
  140  therapy. The resulting changes in treatment shall be
  141  specifically documented in the patient’s medical record.
  142  Evidence or behavioral indications of diversion shall be
  143  followed by discontinuation of controlled substance therapy, and
  144  the patient shall be discharged, and all results of testing and
  145  actions taken by the registrant physician shall be documented in
  146  the patient’s medical record.
  148  This subsection does not apply to a board-eligible or board
  149  certified anesthesiologist, physiatrist, rheumatologist, or
  150  neurologist, or to a board-certified physician who has surgical
  151  privileges at a hospital or ambulatory surgery center and
  152  primarily provides surgical services. This subsection does not
  153  apply to a board-eligible or board-certified medical specialist
  154  who has also completed a fellowship in pain medicine approved by
  155  the Accreditation Council for Graduate Medical Education or the
  156  American Osteopathic Association, or who is board eligible or
  157  board certified in pain medicine by the American Board of Pain
  158  Medicine, the American Board of Interventional Pain Physicians,
  159  the American Association of Physician Specialists, or a board
  160  approved by the American Board of Medical Specialties or the
  161  American Osteopathic Association and performs interventional
  162  pain procedures of the type routinely billed using surgical
  163  codes. This subsection does not apply to a registrant physician
  164  who prescribes medically necessary controlled substances for a
  165  patient during an inpatient stay in a hospital licensed under
  166  chapter 395.
  167         Section 5. Paragraph (b) of subsection (2) of section
  168  458.3265, Florida Statutes, is amended to read:
  169         458.3265 Pain-management clinics.—
  170         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  171  apply to any physician who provides professional services in a
  172  pain-management clinic that is required to be registered in
  173  subsection (1).
  174         (b) Only a person may not dispense any medication on the
  175  premises of a registered pain-management clinic unless he or she
  176  is a physician licensed under this chapter or chapter 459 may
  177  dispense medication or prescribe a controlled substance
  178  regulated under chapter 893 on the premises of a registered
  179  pain-management clinic.
  180         Section 6. Paragraph (b) of subsection (2) of section
  181  459.0137, Florida Statutes, is amended to read:
  182         459.0137 Pain-management clinics.—
  183         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
  184  apply to any osteopathic physician who provides professional
  185  services in a pain-management clinic that is required to be
  186  registered in subsection (1).
  187         (b) Only a person may not dispense any medication on the
  188  premises of a registered pain-management clinic unless he or she
  189  is a physician licensed under this chapter or chapter 458 may
  190  dispense medication or prescribe a controlled substance
  191  regulated under chapter 893 on the premises of a registered
  192  pain-management clinic.
  193         Section 7. Section 464.012, Florida Statutes, is amended to
  194  read:
  195         464.012 Certification of advanced registered nurse
  196  practitioners; fees.—
  197         (1) Any nurse desiring to be certified as an advanced
  198  registered nurse practitioner shall apply to the department and
  199  submit proof that he or she holds a current license to practice
  200  professional nursing and that he or she meets one or more of the
  201  following requirements as determined by the board:
  202         (a) Satisfactory completion of a formal postbasic
  203  educational program of at least one academic year, the primary
  204  purpose of which is to prepare nurses for advanced or
  205  specialized practice.
  206         (b) Certification by an appropriate specialty board. Such
  207  certification shall be required for initial state certification
  208  and any recertification as a registered nurse anesthetist,
  209  psychiatric nurse, or nurse midwife. The board may by rule
  210  provide for provisional state certification of graduate nurse
  211  anesthetists, psychiatric nurses, and nurse midwives for a
  212  period of time determined to be appropriate for preparing for
  213  and passing the national certification examination.
  214         (c) Graduation from a program leading to a master’s degree
  215  in a nursing clinical specialty area with preparation in
  216  specialized practitioner skills. For applicants graduating on or
  217  after October 1, 1998, graduation from a master’s degree program
  218  shall be required for initial certification as a nurse
  219  practitioner under paragraph (4)(c). For applicants graduating
  220  on or after October 1, 2001, graduation from a master’s degree
  221  program shall be required for initial certification as a
  222  registered nurse anesthetist under paragraph (4)(a).
  223         (2) The board shall provide by rule the appropriate
  224  requirements for advanced registered nurse practitioners in the
  225  categories of certified registered nurse anesthetist, certified
  226  nurse midwife, and nurse practitioner.
  227         (3) An advanced registered nurse practitioner shall perform
  228  those functions authorized in this section within the framework
  229  of an established protocol that is filed with the board upon
  230  biennial license renewal and within 30 days after entering into
  231  a supervisory relationship with a physician or changes to the
  232  protocol. The board shall review the protocol to ensure
  233  compliance with applicable regulatory standards for protocols.
  234  The board shall refer to the department licensees submitting
  235  protocols that are not compliant with the regulatory standards
  236  for protocols. A practitioner currently licensed under chapter
  237  458, chapter 459, or chapter 466 shall maintain supervision for
  238  directing the specific course of medical treatment. Within the
  239  established framework, an advanced registered nurse practitioner
  240  may:
  241         (a) Monitor and alter drug therapies.
  242         (b) Initiate appropriate therapies for certain conditions.
  243         (c) Perform additional functions as may be determined by
  244  rule in accordance with s. 464.003(2).
  245         (d) Order diagnostic tests and physical and occupational
  246  therapy.
  247         (4) In addition to the general functions specified in
  248  subsection (3), an advanced registered nurse practitioner may
  249  perform the following acts within his or her specialty:
  250         (a) The certified registered nurse anesthetist may, to the
  251  extent authorized by established protocol approved by the
  252  medical staff of the facility in which the anesthetic service is
  253  performed, perform any or all of the following:
  254         1. Determine the health status of the patient as it relates
  255  to the risk factors and to the anesthetic management of the
  256  patient through the performance of the general functions.
  257         2. Based on history, physical assessment, and supplemental
  258  laboratory results, determine, with the consent of the
  259  responsible physician, the appropriate type of anesthesia within
  260  the framework of the protocol.
  261         3. Order under the protocol preanesthetic medication.
  262         4. Perform under the protocol procedures commonly used to
  263  render the patient insensible to pain during the performance of
  264  surgical, obstetrical, therapeutic, or diagnostic clinical
  265  procedures. These procedures include ordering and administering
  266  regional, spinal, and general anesthesia; inhalation agents and
  267  techniques; intravenous agents and techniques; and techniques of
  268  hypnosis.
  269         5. Order or perform monitoring procedures indicated as
  270  pertinent to the anesthetic health care management of the
  271  patient.
  272         6. Support life functions during anesthesia health care,
  273  including induction and intubation procedures, the use of
  274  appropriate mechanical supportive devices, and the management of
  275  fluid, electrolyte, and blood component balances.
  276         7. Recognize and take appropriate corrective action for
  277  abnormal patient responses to anesthesia, adjunctive medication,
  278  or other forms of therapy.
  279         8. Recognize and treat a cardiac arrhythmia while the
  280  patient is under anesthetic care.
  281         9. Participate in management of the patient while in the
  282  postanesthesia recovery area, including ordering the
  283  administration of fluids and drugs.
  284         10. Place special peripheral and central venous and
  285  arterial lines for blood sampling and monitoring as appropriate.
  286         (b) The certified nurse midwife may, to the extent
  287  authorized by an established protocol which has been approved by
  288  the medical staff of the health care facility in which the
  289  midwifery services are performed, or approved by the nurse
  290  midwife’s physician backup when the delivery is performed in a
  291  patient’s home, perform any or all of the following:
  292         1. Perform superficial minor surgical procedures.
  293         2. Manage the patient during labor and delivery to include
  294  amniotomy, episiotomy, and repair.
  295         3. Order, initiate, and perform appropriate anesthetic
  296  procedures.
  297         4. Perform postpartum examination.
  298         5. Order appropriate medications.
  299         6. Provide family-planning services and well-woman care.
  300         7. Manage the medical care of the normal obstetrical
  301  patient and the initial care of a newborn patient.
  302         (c) The nurse practitioner may perform any or all of the
  303  following acts within the framework of established protocol:
  304         1. Manage selected medical problems.
  305         2. Order physical and occupational therapy.
  306         3. Initiate, monitor, or alter therapies for certain
  307  uncomplicated acute illnesses.
  308         4. Monitor and manage patients with stable chronic
  309  diseases.
  310         5. Establish behavioral problems and diagnosis and make
  311  treatment recommendations.
  312         (5) A psychiatric nurse, as defined in s. 394.455, within
  313  the framework of an established protocol with a psychiatrist,
  314  may prescribe psychotropic controlled substances for the
  315  treatment of mental disorders.
  316         (6) The board shall certify, and the department shall issue
  317  a certificate to, any nurse meeting the qualifications in this
  318  section. The board shall establish an application fee not to
  319  exceed $100 and a biennial renewal fee not to exceed $50. The
  320  board is authorized to adopt such other rules as are necessary
  321  to implement the provisions of this section.
  322         Section 8. Paragraph (p) is added to subsection (1) of
  323  section 464.018, Florida Statutes, and subsection (2) of that
  324  section is republished, to read:
  325         464.018 Disciplinary actions.—
  326         (1) The following acts constitute grounds for denial of a
  327  license or disciplinary action, as specified in s. 456.072(2):
  328         (p) For a psychiatric nurse:
  329         1. Presigning blank prescription forms.
  330         2. Prescribing for office use any medicinal drug appearing
  331  in Schedule II of s. 893.03.
  332         3. Prescribing, ordering, dispensing, administering,
  333  supplying, selling, or giving a drug that is an amphetamine, a
  334  sympathomimetic amine drug, or a compound designated in s.
  335  893.03(2) as a Schedule II controlled substance, to or for any
  336  person except for:
  337         a. The treatment of narcolepsy; hyperkinesis; behavioral
  338  syndrome in children characterized by the developmentally
  339  inappropriate symptoms of moderate to severe distractibility,
  340  short attention span, hyperactivity, emotional lability, and
  341  impulsivity; or drug-induced brain dysfunction.
  342         b. The differential diagnostic psychiatric evaluation of
  343  depression or the treatment of depression shown to be refractory
  344  to other therapeutic modalities.
  345         c. The clinical investigation of the effects of such drugs
  346  or compounds when an investigative protocol is submitted to,
  347  reviewed by, and approved by the department before such
  348  investigation is begun.
  349         4. Prescribing, ordering, dispensing, administering,
  350  supplying, selling, or giving growth hormones, testosterone or
  351  its analogs, human chorionic gonadotropin (HCG), or other
  352  hormones for the purpose of muscle building or to enhance
  353  athletic performance. As used in this subparagraph, the term
  354  “muscle building” does not include the treatment of injured
  355  muscle. A prescription written for the drug products identified
  356  in this subparagraph may be dispensed by a pharmacist with the
  357  presumption that the prescription is for legitimate medical use.
  358         5. Promoting or advertising on any prescription form a
  359  community pharmacy unless the form also states: “This
  360  prescription may be filled at any pharmacy of your choice.”
  361         6. Prescribing, dispensing, administering, mixing, or
  362  otherwise preparing a legend drug, including a controlled
  363  substance, other than in the course of his or her professional
  364  practice. For the purposes of this subparagraph, it is legally
  365  presumed that prescribing, dispensing, administering, mixing, or
  366  otherwise preparing legend drugs, including all controlled
  367  substances, inappropriately or in excessive or inappropriate
  368  quantities is not in the best interest of the patient and is not
  369  in the course of the advanced registered nurse practitioner’s
  370  professional practice, without regard to his or her intent.
  371         7. Prescribing, dispensing, or administering a medicinal
  372  drug appearing on any schedule set forth in chapter 893 to
  373  himself or herself, except a drug prescribed, dispensed, or
  374  administered to the psychiatric nurse by another practitioner
  375  authorized to prescribe, dispense, or administer medicinal
  376  drugs.
  377         8. Prescribing, ordering, dispensing, administering,
  378  supplying, selling, or giving amygdalin (laetrile) to any
  379  person.
  380         9. Dispensing a substance designated in s. 893.03(2) or (3)
  381  as a substance controlled in Schedule II or Schedule III,
  382  respectively, in violation of s. 465.0276.
  383         10. Promoting or advertising through any communication
  384  medium the use, sale, or dispensing of a substance designated in
  385  s. 893.03 as a controlled substance.
  386         (2) The board may enter an order denying licensure or
  387  imposing any of the penalties in s. 456.072(2) against any
  388  applicant for licensure or licensee who is found guilty of
  389  violating any provision of subsection (1) of this section or who
  390  is found guilty of violating any provision of s. 456.072(1).
  391         Section 9. Subsection (21) of section 893.02, Florida
  392  Statutes, is amended to read:
  393         893.02 Definitions.—The following words and phrases as used
  394  in this chapter shall have the following meanings, unless the
  395  context otherwise requires:
  396         (21) “Practitioner” means a physician licensed pursuant to
  397  chapter 458, a dentist licensed pursuant to chapter 466, a
  398  veterinarian licensed pursuant to chapter 474, an osteopathic
  399  physician licensed pursuant to chapter 459, a naturopath
  400  licensed pursuant to chapter 462, a certified optometrist
  401  licensed pursuant to chapter 463, a psychiatric nurse as defined
  402  in s. 394.455, or a podiatric physician licensed pursuant to
  403  chapter 461, provided such practitioner holds a valid federal
  404  controlled substance registry number.
  406  ================= T I T L E  A M E N D M E N T ================
  407  And the title is amended as follows:
  408         Delete line 123
  409  and insert:
  410         provider personnel; amending s. 456.44, F.S.; defining
  411         the term “registrant”; requiring psychiatric nurses to
  412         make certain designations and comply with certain
  413         requirements under specified circumstances; amending
  414         s. 458.3265, F.S.; restricting to physicians the
  415         authorization to dispense certain medications or
  416         prescribe certain controlled substances on the
  417         premises of a registered pain-management clinic;
  418         amending s. 459.0137, F.S.; restricting to osteopathic
  419         physicians the authorization to dispense certain
  420         medications or prescribe certain controlled substances
  421         on the premises of a registered pain-management
  422         clinic; amending s. 464.012, F.S.; providing
  423         certification criteria for psychiatric nurses;
  424         authorizing psychiatric nurses to prescribe certain
  425         psychotropic controlled substances under certain
  426         circumstances; amending s. 464.018; providing that
  427         certain acts by a psychiatric nurse constitute grounds
  428         for denial of a license or disciplinary action;
  429         amending s. 893.02, F.S.; revising the definition of
  430         the term “practitioner”; providing an effective date.