Florida Senate - 2015                        COMMITTEE AMENDMENT
       Bill No. CS for CS for SB 614
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                   Comm: WD            .                                
                  04/20/2015           .                                

       The Committee on Rules (Soto) recommended the following:
    1         Senate Amendment to Amendment (395678) (with title
    2  amendment)
    4         Delete lines 296 - 731
    5  and insert:
    7  This subsection does not apply to a board-eligible or board
    8  certified anesthesiologist, physiatrist, rheumatologist, or
    9  neurologist, or to a board-certified physician who has surgical
   10  privileges at a hospital or ambulatory surgery center and
   11  primarily provides surgical services. This subsection does not
   12  apply to a board-eligible or board-certified medical specialist
   13  who has also completed a fellowship in pain medicine approved by
   14  the Accreditation Council for Graduate Medical Education or the
   15  American Osteopathic Association, or who is board eligible or
   16  board certified in pain medicine by the American Board of Pain
   17  Medicine, the American Board of Interventional Pain Physicians,
   18  the American Association of Physician Specialists, or a board
   19  approved by the American Board of Medical Specialties or the
   20  American Osteopathic Association and performs interventional
   21  pain procedures of the type routinely billed using surgical
   22  codes. This subsection does not apply to a registrant, advanced
   23  registered nurse practitioner, or physician assistant who
   24  prescribes medically necessary controlled substances for a
   25  patient during an inpatient stay in a hospital licensed under
   26  chapter 395.
   27         Section 9. Section 458.326, Florida Statutes, is amended to
   28  read:
   29         458.326 Intractable pain; authorized treatment;
   30  interventional pain medicine; unauthorized practice.—
   31         (1)(a) For the purposes of this subsection section, the
   32  term “intractable pain” means pain for which, in the generally
   33  accepted course of medical practice, the cause cannot be removed
   34  and otherwise treated.
   35         (b)(2) Intractable pain must be diagnosed by a physician
   36  licensed under this chapter and qualified by experience to
   37  render such diagnosis.
   38         (c)(3) Notwithstanding any other provision of law, a
   39  physician may prescribe or administer any controlled substance
   40  under Schedules II-V, as provided for in s. 893.03, to a person
   41  for the treatment of intractable pain, provided the physician
   42  does so in accordance with that level of care, skill, and
   43  treatment recognized by a reasonably prudent physician under
   44  similar conditions and circumstances.
   45         (d)(4) Nothing in this section shall be construed to
   46  condone, authorize, or approve mercy killing or euthanasia, and
   47  no treatment authorized by this section may be used for such
   48  purpose.
   49         (2)(a) For the purposes of this subsection, the term
   50  “interventional pain medicine” means the practice of medicine
   51  devoted to the diagnosis and treatment of pain-related
   52  disorders, principally with the application of interventional
   53  techniques in managing chronic, intractable pain, independently
   54  or in conjunction with other treatment modalities. These
   55  techniques include minimally invasive procedures, including
   56  percutaneous precision needle placement, with placement of drugs
   57  in targeted areas or destruction of targeted nerves, and some
   58  surgical techniques such as laser or endoscopic discectomy,
   59  cement stabilization of spine fractures, intrathecal infusion
   60  pumps, and spinal cord stimulators, for the diagnosis and
   61  management of chronic, intractable pain.
   62         (b) A person may not practice interventional pain medicine
   63  or offer to practice interventional pain medicine unless such
   64  acts are performed at facilities licensed under chapter 395 or
   65  are performed by or under the direct supervision of a physician
   66  licensed under this chapter or an osteopathic physician licensed
   67  under chapter 459.
   68         Section 10. Paragraph (b) of subsection (2) of section
   69  458.3265, Florida Statutes, is amended to read:
   70         458.3265 Pain-management clinics.—
   71         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
   72  apply to any physician who provides professional services in a
   73  pain-management clinic that is required to be registered in
   74  subsection (1).
   75         (b) A person may not dispense any medication on the
   76  premises of a registered pain-management clinic unless he or she
   77  is a physician licensed under this chapter or chapter 459. A
   78  person may not prescribe any controlled substance regulated
   79  under chapter 893 on the premises of a registered pain
   80  management clinic unless he or she is a physician licensed under
   81  this chapter or chapter 459.
   82         Section 11. Paragraph (b) of subsection (2) of section
   83  459.0137, Florida Statutes, is amended to read:
   84         459.0137 Pain-management clinics.—
   85         (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities
   86  apply to any osteopathic physician who provides professional
   87  services in a pain-management clinic that is required to be
   88  registered in subsection (1).
   89         (b) A person may not dispense any medication on the
   90  premises of a registered pain-management clinic unless he or she
   91  is a physician licensed under this chapter or chapter 458. A
   92  person may not prescribe any controlled substance regulated
   93  under chapter 893 on the premises of a registered pain
   94  management clinic unless he or she is a physician licensed under
   95  this chapter or chapter 458.
   96         Section 12. Paragraph (e) of subsection (4) of section
   97  458.347, Florida Statutes, is amended, and paragraph (c) of
   98  subsection (9) of that section is republished, to read:
   99         458.347 Physician assistants.—
  101         (e) A supervisory physician may delegate to a fully
  102  licensed physician assistant the authority to prescribe or
  103  dispense any medication used in the supervisory physician’s
  104  practice unless such medication is listed on the formulary
  105  created pursuant to paragraph (f). A fully licensed physician
  106  assistant may only prescribe or dispense such medication under
  107  the following circumstances:
  108         1. A physician assistant must clearly identify to the
  109  patient that he or she is a physician assistant. Furthermore,
  110  the physician assistant must inform the patient that the patient
  111  has the right to see the physician prior to any prescription
  112  being prescribed or dispensed by the physician assistant.
  113         2. The supervisory physician must notify the department of
  114  his or her intent to delegate, on a department-approved form,
  115  before delegating such authority and notify the department of
  116  any change in prescriptive privileges of the physician
  117  assistant. Authority to dispense may be delegated only by a
  118  supervising physician who is registered as a dispensing
  119  practitioner in compliance with s. 465.0276.
  120         3. The physician assistant must file with the department a
  121  signed affidavit that he or she has completed a minimum of 10
  122  continuing medical education hours in the specialty practice in
  123  which the physician assistant has prescriptive privileges with
  124  each licensure renewal application. Three of the 10 hours must
  125  consist of a continuing education course on the safe and
  126  effective prescribing of controlled substance medications, which
  127  shall be offered by a statewide professional association of
  128  physicians in this state accredited to provide educational
  129  activities designated for the American Medical Association
  130  Physician’s Recognition Award Category I Credit.
  131         4. The department may issue a prescriber number to the
  132  physician assistant granting authority for the prescribing of
  133  medicinal drugs authorized within this paragraph upon completion
  134  of the foregoing requirements. The physician assistant shall not
  135  be required to independently register pursuant to s. 465.0276.
  136         5. The prescription must be written in a form that complies
  137  with chapter 499 and must contain, in addition to the
  138  supervisory physician’s name, address, and telephone number, the
  139  physician assistant’s prescriber number. Unless it is a drug or
  140  drug sample dispensed by the physician assistant, the
  141  prescription must be filled in a pharmacy permitted under
  142  chapter 465 and must be dispensed in that pharmacy by a
  143  pharmacist licensed under chapter 465. The appearance of the
  144  prescriber number creates a presumption that the physician
  145  assistant is authorized to prescribe the medicinal drug and the
  146  prescription is valid.
  147         6. The physician assistant must note the prescription or
  148  dispensing of medication in the appropriate medical record.
  149         (9) COUNCIL ON PHYSICIAN ASSISTANTS.—The Council on
  150  Physician Assistants is created within the department.
  151         (c) The council shall:
  152         1. Recommend to the department the licensure of physician
  153  assistants.
  154         2. Develop all rules regulating the use of physician
  155  assistants by physicians under this chapter and chapter 459,
  156  except for rules relating to the formulary developed under
  157  paragraph (4)(f). The council shall also develop rules to ensure
  158  that the continuity of supervision is maintained in each
  159  practice setting. The boards shall consider adopting a proposed
  160  rule developed by the council at the regularly scheduled meeting
  161  immediately following the submission of the proposed rule by the
  162  council. A proposed rule submitted by the council may not be
  163  adopted by either board unless both boards have accepted and
  164  approved the identical language contained in the proposed rule.
  165  The language of all proposed rules submitted by the council must
  166  be approved by both boards pursuant to each respective board’s
  167  guidelines and standards regarding the adoption of proposed
  168  rules. If either board rejects the council’s proposed rule, that
  169  board must specify its objection to the council with
  170  particularity and include any recommendations it may have for
  171  the modification of the proposed rule.
  172         3. Make recommendations to the boards regarding all matters
  173  relating to physician assistants.
  174         4. Address concerns and problems of practicing physician
  175  assistants in order to improve safety in the clinical practices
  176  of licensed physician assistants.
  177         Section 13. Effective January 1, 2016, paragraph (f) of
  178  subsection (4) of section 458.347, Florida Statutes, is amended
  179  to read:
  180         458.347 Physician assistants.—
  182         (f)1. The council shall establish a formulary of medicinal
  183  drugs that a fully licensed physician assistant having
  184  prescribing authority under this section or s. 459.022 may not
  185  prescribe. The formulary must include controlled substances as
  186  defined in chapter 893, general anesthetics, and radiographic
  187  contrast materials, and must limit the prescription of Schedule
  188  II controlled substances as defined in s. 893.03 to a 7-day
  189  supply. The formulary must also restrict the prescribing of
  190  controlled substances that are psychotropic medications,
  191  including antihypnotics, antipsychotics, antidepressants,
  192  anxiety agents, sedatives, psychomotor stimulants, and mood
  193  stabilizers for children under the age of 18.
  194         2. In establishing the formulary, the council shall consult
  195  with a pharmacist licensed under chapter 465, but not licensed
  196  under this chapter or chapter 459, who shall be selected by the
  197  State Surgeon General.
  198         3. Only the council shall add to, delete from, or modify
  199  the formulary. Any person who requests an addition, deletion, or
  200  modification of a medicinal drug listed on such formulary has
  201  the burden of proof to show cause why such addition, deletion,
  202  or modification should be made.
  203         4. The boards shall adopt the formulary required by this
  204  paragraph, and each addition, deletion, or modification to the
  205  formulary, by rule. Notwithstanding any provision of chapter 120
  206  to the contrary, the formulary rule shall be effective 60 days
  207  after the date it is filed with the Secretary of State. Upon
  208  adoption of the formulary, the department shall mail a copy of
  209  such formulary to each fully licensed physician assistant having
  210  prescribing authority under this section or s. 459.022, and to
  211  each pharmacy licensed by the state. The boards shall establish,
  212  by rule, a fee not to exceed $200 to fund the provisions of this
  213  paragraph and paragraph (e).
  214         Section 14. Subsection (2) of section 464.003, Florida
  215  Statutes, is amended to read:
  216         464.003 Definitions.—As used in this part, the term:
  217         (2) “Advanced or specialized nursing practice” means, in
  218  addition to the practice of professional nursing, the
  219  performance of advanced-level nursing acts approved by the board
  220  which, by virtue of postbasic specialized education, training,
  221  and experience, are appropriately performed by an advanced
  222  registered nurse practitioner. Within the context of advanced or
  223  specialized nursing practice, the advanced registered nurse
  224  practitioner may perform acts of nursing diagnosis and nursing
  225  treatment of alterations of the health status. The advanced
  226  registered nurse practitioner may also perform acts of medical
  227  diagnosis and treatment, prescription, and operation as
  228  authorized within the framework of an established supervisory
  229  protocol which are identified and approved by a joint committee
  230  composed of three members appointed by the Board of Nursing, two
  231  of whom must be advanced registered nurse practitioners; three
  232  members appointed by the Board of Medicine, two of whom must
  233  have had work experience with advanced registered nurse
  234  practitioners; and the State Surgeon General or the State
  235  Surgeon General’s designee. Each committee member appointed by a
  236  board shall be appointed to a term of 4 years unless a shorter
  237  term is required to establish or maintain staggered terms. The
  238  Board of Nursing shall adopt rules authorizing the performance
  239  of any such acts approved by the joint committee. Unless
  240  otherwise specified by the joint committee, such acts must be
  241  performed under the general supervision of a practitioner
  242  licensed under chapter 458, chapter 459, or chapter 466 within
  243  the framework of standing protocols which identify the medical
  244  acts to be performed and the conditions for their performance.
  245  The department may, by rule, require that a copy of the protocol
  246  be filed with the department along with the notice required by
  247  s. 458.348.
  248         Section 15. Subsection (6) is added to section 464.012,
  249  Florida Statutes, to read:
  250         464.012 Certification of advanced registered nurse
  251  practitioners; fees; controlled substance prescribing.—
  252         (6)(a) The board shall establish a committee to recommend a
  253  formulary of controlled substances that an advanced registered
  254  nurse practitioner may not prescribe or may prescribe only for
  255  specific uses or in limited quantities. The committee must
  256  consist of three advanced registered nurse practitioners
  257  licensed under s. 464.012, recommended by the Board of Nursing;
  258  three physicians licensed under chapter 458 or chapter 459 who
  259  have had work experience with advanced registered nurse
  260  practitioners, recommended by the Board of Medicine; and a
  261  pharmacist licensed under chapter 465 who holds a Doctor of
  262  Pharmacy degree, recommended by the Board of Pharmacy. The
  263  committee may recommend an evidence-based formulary applicable
  264  to all advanced registered nurse practitioners, which is limited
  265  by specially certification or to approved uses of controlled
  266  substances, or subject to other similar restrictions the
  267  committee finds are necessary to protect the health, safety, and
  268  welfare of the public. The formulary must restrict the
  269  prescribing of controlled substance psychotropic medications,
  270  including antihypnotics, antipsychotics, antidepressants,
  271  anxiety agents, sedatives, psychomotor stimulants, and mood
  272  stabilizers for children under the age of 18 to psychiatric
  273  nurses as defined in s. 394.455. The formulary must also limit
  274  the prescribing of Schedule II controlled substances as defined
  275  in s. 893.03 to a 7-day supply, except that such restriction
  276  does not apply to controlled substances that are psychiatric
  277  medications prescribed by psychiatric nurses as defined in s.
  278  394.455.
  279         (b)The board shall adopt by rule the recommended formulary
  280  and recommended additions or deletions to the formulary which it
  281  finds are supported by evidence-based clinical findings
  282  presented by the Board of Medicine, the Board of Osteopathic
  283  Medicine, or the Board of Dentistry.
  284         (c)The formulary required under this subsection does not
  285  apply to a controlled substance order that is dispensed for
  286  administration including orders for medication authorized in
  287  subparagraph (4)(a)3. or subparagraph (4)(a)4.
  288         (d) The board shall adopt the committee’s initial
  289  recommendation no later January 1, 2016.
  290         Section 16. Effective January 1, 2016, subsection (3) of
  291  section 464.012, Florida Statutes, is amended to read:
  292         464.012 Certification of advanced registered nurse
  293  practitioners; fees; controlled substance prescribing.—
  294         (3) An advanced registered nurse practitioner shall perform
  295  those functions authorized in this section within the framework
  296  of an established protocol that is filed with the board upon
  297  biennial license renewal and within 30 days after entering into
  298  a supervisory relationship with a physician or changes to the
  299  protocol. The board shall review the protocol to ensure
  300  compliance with applicable regulatory standards for protocols.
  301  The board shall refer to the department licensees submitting
  302  protocols that are not compliant with the regulatory standards
  303  for protocols. A practitioner currently licensed under chapter
  304  458, chapter 459, or chapter 466 shall maintain supervision for
  305  directing the specific course of medical treatment. Within the
  306  established framework, an advanced registered nurse practitioner
  307  may:
  308         (a) Prescribe, dispense, administer, or order any drug;
  309  however, an advanced registered nurse practitioner may only
  310  prescribe or dispense a controlled substance as defined in s.
  311  893.03 if the advanced registered nurse practitioner has
  312  graduated from a program leading to a master’s degree in a
  313  clinical nursing specialty area with training in specialized
  314  practitioner skills. Monitor and alter drug therapies.
  315         (b) Initiate appropriate therapies for certain conditions.
  316         (c) Perform additional functions as may be determined by
  317  rule in accordance with s. 464.003(2).
  318         (d) Order diagnostic tests and physical and occupational
  319  therapy.
  320         Section 17. Subsection (3) of section 464.013, Florida
  321  Statutes, is amended to read:
  322         464.013 Renewal of license or certificate.—
  323         (3) The board shall by rule prescribe up to 30 hours of
  324  continuing education biennially as a condition for renewal of a
  325  license or certificate.
  326         (a) A nurse who is certified by a health care specialty
  327  program accredited by the National Commission for Certifying
  328  Agencies or the Accreditation Board for Specialty Nursing
  329  Certification is exempt from continuing education requirements.
  330  The criteria for programs must shall be approved by the board.
  331         (b) Notwithstanding the exemption in paragraph (a), as part
  332  of the maximum 30 hours of continuing education hours required
  333  under this subsection, advanced registered nurse practitioners
  334  certified under s. 464.012 must complete at least 3 hours of
  335  continuing education on the safe and effective prescription of
  336  controlled substances. Such continuing education courses must be
  337  offered by a statewide professional association of physicians in
  338  this state accredited to provide educational activities
  339  designated for the American Medical Association Physician’s
  340  Recognition Award Category 1 Credit, the American Nurses
  341  Credentialing Center, or the American Association of Nurse
  342  Practitioners and may be offered in a distance-learning format.
  343         Section 18. Paragraph (p) is added to subsection (1) of
  344  section 464.018, Florida Statutes, and subsection (2) of that
  345  section is republished, to read:
  346         464.018 Disciplinary actions.—
  347         (1) The following acts constitute grounds for denial of a
  348  license or disciplinary action, as specified in s. 456.072(2):
  349         (p)For an advanced registered nurse practitioner:
  350         1.Presigning blank prescription forms.
  351         2.Prescribing for office use any medicinal drug appearing
  352  on Schedule II in chapter 893.
  353         3.Prescribing, ordering, dispensing, administering,
  354  supplying, selling, or giving a drug that is an amphetamine or a
  355  sympathomimetic amine drug, or a compound designated pursuant to
  356  chapter 893 as a Schedule II controlled substance, to or for any
  357  person except for:
  358         a. The treatment of narcolepsy; hyperkinesis; behavioral
  359  syndrome in children characterized by the developmentally
  360  inappropriate symptoms of moderate to severe distractibility,
  361  short attention span, hyperactivity, emotional lability, and
  362  impulsivity; or drug-induced brain dysfunction.
  363         b. The differential diagnostic psychiatric evaluation of
  364  depression or the treatment of depression shown to be refractory
  365  to other therapeutic modalities.
  366         c. The clinical investigation of the effects of such drugs
  367  or compounds when an investigative protocol is submitted to,
  368  reviewed by, and approved by the department before such
  369  investigation is begun.
  370         4. Prescribing, ordering, dispensing, administering,
  371  supplying, selling, or giving growth hormones, testosterone or
  372  its analogs, human chorionic gonadotropin (HCG), or other
  373  hormones for the purpose of muscle building or to enhance
  374  athletic performance. As used in this subparagraph, the term
  375  “muscle building” does not include the treatment of injured
  376  muscle. A prescription written for the drug products listed in
  377  this paragraph may be dispensed by a pharmacist with the
  378  presumption that the prescription is for legitimate medical use.
  379         5. Promoting or advertising on any prescription form a
  380  community pharmacy unless the form also states: “This
  381  prescription may be filled at any pharmacy of your choice.”
  382         6.Prescribing, dispensing, administering, mixing, or
  383  otherwise preparing a legend drug, including a controlled
  384  substance, other than in the course of his or her professional
  385  practice. For the purposes of this subparagraph, it is legally
  386  presumed that prescribing, dispensing, administering, mixing, or
  387  otherwise preparing legend drugs, including all controlled
  388  substances, inappropriately or in excessive or inappropriate
  389  quantities is not in the best interest of the patient and is not
  390  in the course of the advanced registered nurse practitioner’s
  391  professional practice, without regard to his or her intent.
  392         7.Prescribing, dispensing, or administering a medicinal
  393  drug appearing on any schedule set forth in chapter 893 to
  394  himself or herself, except a drug prescribed, dispensed, or
  395  administered to the advanced registered nurse practitioner by
  396  another practitioner authorized to prescribe, dispense, or
  397  administer medicinal drugs.
  398         8.Prescribing, ordering, dispensing, administering,
  399  supplying, selling, or giving amygdalin (laetrile) to any
  400  person.
  401         9.Dispensing a controlled substance listed on Schedule II
  402  or Schedule III in chapter 893 in violation of s. 465.0276.
  403         10.Promoting or advertising through any communication
  404  medium the use, sale, or dispensing of a controlled substance
  405  appearing on any schedule in chapter 893.
  406         (2) The board may enter an order denying licensure or
  407  imposing any of the penalties in s. 456.072(2) against any
  408  applicant for licensure or licensee who is found guilty of
  409  violating any provision of subsection (1) of this section or who
  410  is found guilty of violating any provision of s. 456.072(1).
  412  ================= T I T L E  A M E N D M E N T ================
  413  And the title is amended as follows:
  414         Delete lines 908 - 952
  415  and insert:
  416         standards of practice; providing applicability;
  417         amending s. 458.326, F.S.; defining the term
  418         “interventional pain medicine”; restricting the
  419         practice of interventional pain medicine to specified
  420         circumstances; amending ss. 458.3265 and 459.0137,
  421         F.S.; limiting the authority to prescribe a controlled
  422         substance in a pain-management clinic to a physician
  423         licensed under ch. 458 or ch. 459, F.S.; amending s.
  424         458.347, F.S.; revising the required continuing
  425         education requirements for a physician assistant;
  426         amending s. 458.347, F.S.; requiring the Council of
  427         Physician Assistants to create a formulary which
  428         includes the controlled substances a physician
  429         assistant is authorized to prescribe; amending s.
  430         464.003, F.S.; redefining the term “advanced or
  431         specialized nursing practice”; removing the joint
  432         committee established in the definition; amending s.
  433         464.012, F.S.; requiring the Board of Nursing to
  434         establish a committee to make recommendations
  435         regarding the need for adoption of a formulary of
  436         controlled substances that may be prescribed by an
  437         advanced registered nurse practitioner; specifying the
  438         membership of the committee; providing parameters for
  439         the recommendations of the committee; requiring that
  440         any formulary be adopted by board rule; specifying the
  441         process for amending the formulary and imposing a
  442         burden of proof; limiting the formulary’s application
  443         in certain instances; requiring the board to adopt the
  444         committee’s initial recommendations by a specified
  445         date; amending s. 464.012, F.S.; authorizing an
  446         advanced registered nurse practitioner to prescribe,
  447         dispense, administer, or order drugs, rather than to
  448         monitor and alter drug therapies; providing an
  449         exception; amending s. 464.013, F.S.; revising
  450         conditions for renewal of a license or certificate;
  451         amending s. 464.018, F.S.; specifying acts that
  452         constitute grounds for denial of a license or for
  453         disciplinary action against an advanced registered
  454         nurse practitioner;