Florida Senate - 2015                        COMMITTEE AMENDMENT
       Bill No. CS for CS for SB 614
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  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  psychiatric mental health controlled substances for children
  191  under 18 years of age.
  192         2. In establishing the formulary, the council shall consult
  193  with a pharmacist licensed under chapter 465, but not licensed
  194  under this chapter or chapter 459, who shall be selected by the
  195  State Surgeon General.
  196         3. Only the council shall add to, delete from, or modify
  197  the formulary. Any person who requests an addition, deletion, or
  198  modification of a medicinal drug listed on such formulary has
  199  the burden of proof to show cause why such addition, deletion,
  200  or modification should be made.
  201         4. The boards shall adopt the formulary required by this
  202  paragraph, and each addition, deletion, or modification to the
  203  formulary, by rule. Notwithstanding any provision of chapter 120
  204  to the contrary, the formulary rule shall be effective 60 days
  205  after the date it is filed with the Secretary of State. Upon
  206  adoption of the formulary, the department shall mail a copy of
  207  such formulary to each fully licensed physician assistant having
  208  prescribing authority under this section or s. 459.022, and to
  209  each pharmacy licensed by the state. The boards shall establish,
  210  by rule, a fee not to exceed $200 to fund the provisions of this
  211  paragraph and paragraph (e).
  212         Section 14. Subsection (2) of section 464.003, Florida
  213  Statutes, is amended to read:
  214         464.003 Definitions.—As used in this part, the term:
  215         (2) “Advanced or specialized nursing practice” means, in
  216  addition to the practice of professional nursing, the
  217  performance of advanced-level nursing acts approved by the board
  218  which, by virtue of postbasic specialized education, training,
  219  and experience, are appropriately performed by an advanced
  220  registered nurse practitioner. Within the context of advanced or
  221  specialized nursing practice, the advanced registered nurse
  222  practitioner may perform acts of nursing diagnosis and nursing
  223  treatment of alterations of the health status. The advanced
  224  registered nurse practitioner may also perform acts of medical
  225  diagnosis and treatment, prescription, and operation as
  226  authorized within the framework of an established supervisory
  227  protocol which are identified and approved by a joint committee
  228  composed of three members appointed by the Board of Nursing, two
  229  of whom must be advanced registered nurse practitioners; three
  230  members appointed by the Board of Medicine, two of whom must
  231  have had work experience with advanced registered nurse
  232  practitioners; and the State Surgeon General or the State
  233  Surgeon General’s designee. Each committee member appointed by a
  234  board shall be appointed to a term of 4 years unless a shorter
  235  term is required to establish or maintain staggered terms. The
  236  Board of Nursing shall adopt rules authorizing the performance
  237  of any such acts approved by the joint committee. Unless
  238  otherwise specified by the joint committee, such acts must be
  239  performed under the general supervision of a practitioner
  240  licensed under chapter 458, chapter 459, or chapter 466 within
  241  the framework of standing protocols which identify the medical
  242  acts to be performed and the conditions for their performance.
  243  The department may, by rule, require that a copy of the protocol
  244  be filed with the department along with the notice required by
  245  s. 458.348.
  246         Section 15. Subsection (6) is added to section 464.012,
  247  Florida Statutes, to read:
  248         464.012 Certification of advanced registered nurse
  249  practitioners; fees; controlled substance prescribing.—
  250         (6)(a) The board shall establish a committee to recommend a
  251  formulary of controlled substances that an advanced registered
  252  nurse practitioner may not prescribe or may prescribe only for
  253  specific uses or in limited quantities. The committee must
  254  consist of three advanced registered nurse practitioners
  255  licensed under s. 464.012, recommended by the Board of Nursing;
  256  three physicians licensed under chapter 458 or chapter 459 who
  257  have had work experience with advanced registered nurse
  258  practitioners, recommended by the Board of Medicine; and a
  259  pharmacist licensed under chapter 465 who holds a Doctor of
  260  Pharmacy degree, recommended by the Board of Pharmacy. The
  261  committee may recommend an evidence-based formulary applicable
  262  to all advanced registered nurse practitioners, which is limited
  263  by specially certification or to approved uses of controlled
  264  substances, or subject to other similar restrictions the
  265  committee finds are necessary to protect the health, safety, and
  266  welfare of the public. The formulary must restrict the
  267  prescribing of psychiatric mental health controlled substances
  268  for children under 18 years of age to psychiatric nurses as
  269  defined in s. 394.455. The formulary must also limit the
  270  prescribing of Schedule II controlled substances as defined in
  271  s. 893.03 to a 7-day supply, except that such restriction does
  272  not apply to controlled substances that are psychiatric
  273  medications prescribed by psychiatric nurses as defined in s.
  274  394.455.
  275         (b)The board shall adopt by rule the recommended formulary
  276  and recommended additions or deletions to the formulary which it
  277  finds are supported by evidence-based clinical findings
  278  presented by the Board of Medicine, the Board of Osteopathic
  279  Medicine, or the Board of Dentistry.
  280         (c)The formulary required under this subsection does not
  281  apply to a controlled substance order that is dispensed for
  282  administration including orders for medication authorized in
  283  subparagraph (4)(a)3. or subparagraph (4)(a)4.
  284         (d) The board shall adopt the committee’s initial
  285  recommendation no later January 1, 2016.
  286         Section 16. Effective January 1, 2016, subsection (3) of
  287  section 464.012, Florida Statutes, is amended to read:
  288         464.012 Certification of advanced registered nurse
  289  practitioners; fees; controlled substance prescribing.—
  290         (3) An advanced registered nurse practitioner shall perform
  291  those functions authorized in this section within the framework
  292  of an established protocol that is filed with the board upon
  293  biennial license renewal and within 30 days after entering into
  294  a supervisory relationship with a physician or changes to the
  295  protocol. The board shall review the protocol to ensure
  296  compliance with applicable regulatory standards for protocols.
  297  The board shall refer to the department licensees submitting
  298  protocols that are not compliant with the regulatory standards
  299  for protocols. A practitioner currently licensed under chapter
  300  458, chapter 459, or chapter 466 shall maintain supervision for
  301  directing the specific course of medical treatment. Within the
  302  established framework, an advanced registered nurse practitioner
  303  may:
  304         (a) Prescribe, dispense, administer, or order any drug;
  305  however, an advanced registered nurse practitioner may only
  306  prescribe or dispense a controlled substance as defined in s.
  307  893.03 if the advanced registered nurse practitioner has
  308  graduated from a program leading to a master’s degree in a
  309  clinical nursing specialty area with training in specialized
  310  practitioner skills. Monitor and alter drug therapies.
  311         (b) Initiate appropriate therapies for certain conditions.
  312         (c) Perform additional functions as may be determined by
  313  rule in accordance with s. 464.003(2).
  314         (d) Order diagnostic tests and physical and occupational
  315  therapy.
  316         Section 17. Subsection (3) of section 464.013, Florida
  317  Statutes, is amended to read:
  318         464.013 Renewal of license or certificate.—
  319         (3) The board shall by rule prescribe up to 30 hours of
  320  continuing education biennially as a condition for renewal of a
  321  license or certificate.
  322         (a) A nurse who is certified by a health care specialty
  323  program accredited by the National Commission for Certifying
  324  Agencies or the Accreditation Board for Specialty Nursing
  325  Certification is exempt from continuing education requirements.
  326  The criteria for programs must shall be approved by the board.
  327         (b) Notwithstanding the exemption in paragraph (a), as part
  328  of the maximum 30 hours of continuing education hours required
  329  under this subsection, advanced registered nurse practitioners
  330  certified under s. 464.012 must complete at least 3 hours of
  331  continuing education on the safe and effective prescription of
  332  controlled substances. Such continuing education courses must be
  333  offered by a statewide professional association of physicians in
  334  this state accredited to provide educational activities
  335  designated for the American Medical Association Physician’s
  336  Recognition Award Category 1 Credit, the American Nurses
  337  Credentialing Center, or the American Association of Nurse
  338  Practitioners and may be offered in a distance-learning format.
  339         Section 18. Paragraph (p) is added to subsection (1) of
  340  section 464.018, Florida Statutes, and subsection (2) of that
  341  section is republished, to read:
  342         464.018 Disciplinary actions.—
  343         (1) The following acts constitute grounds for denial of a
  344  license or disciplinary action, as specified in s. 456.072(2):
  345         (p)For an advanced registered nurse practitioner:
  346         1.Presigning blank prescription forms.
  347         2.Prescribing for office use any medicinal drug appearing
  348  on Schedule II in chapter 893.
  349         3.Prescribing, ordering, dispensing, administering,
  350  supplying, selling, or giving a drug that is an amphetamine or a
  351  sympathomimetic amine drug, or a compound designated pursuant to
  352  chapter 893 as a Schedule II controlled substance, to or for any
  353  person except for:
  354         a. The treatment of narcolepsy; hyperkinesis; behavioral
  355  syndrome in children characterized by the developmentally
  356  inappropriate symptoms of moderate to severe distractibility,
  357  short attention span, hyperactivity, emotional lability, and
  358  impulsivity; or drug-induced brain dysfunction.
  359         b. The differential diagnostic psychiatric evaluation of
  360  depression or the treatment of depression shown to be refractory
  361  to other therapeutic modalities.
  362         c. The clinical investigation of the effects of such drugs
  363  or compounds when an investigative protocol is submitted to,
  364  reviewed by, and approved by the department before such
  365  investigation is begun.
  366         4. Prescribing, ordering, dispensing, administering,
  367  supplying, selling, or giving growth hormones, testosterone or
  368  its analogs, human chorionic gonadotropin (HCG), or other
  369  hormones for the purpose of muscle building or to enhance
  370  athletic performance. As used in this subparagraph, the term
  371  “muscle building” does not include the treatment of injured
  372  muscle. A prescription written for the drug products listed in
  373  this paragraph may be dispensed by a pharmacist with the
  374  presumption that the prescription is for legitimate medical use.
  375         5. Promoting or advertising on any prescription form a
  376  community pharmacy unless the form also states: “This
  377  prescription may be filled at any pharmacy of your choice.”
  378         6.Prescribing, dispensing, administering, mixing, or
  379  otherwise preparing a legend drug, including a controlled
  380  substance, other than in the course of his or her professional
  381  practice. For the purposes of this subparagraph, it is legally
  382  presumed that prescribing, dispensing, administering, mixing, or
  383  otherwise preparing legend drugs, including all controlled
  384  substances, inappropriately or in excessive or inappropriate
  385  quantities is not in the best interest of the patient and is not
  386  in the course of the advanced registered nurse practitioner’s
  387  professional practice, without regard to his or her intent.
  388         7.Prescribing, dispensing, or administering a medicinal
  389  drug appearing on any schedule set forth in chapter 893 to
  390  himself or herself, except a drug prescribed, dispensed, or
  391  administered to the advanced registered nurse practitioner by
  392  another practitioner authorized to prescribe, dispense, or
  393  administer medicinal drugs.
  394         8.Prescribing, ordering, dispensing, administering,
  395  supplying, selling, or giving amygdalin (laetrile) to any
  396  person.
  397         9.Dispensing a controlled substance listed on Schedule II
  398  or Schedule III in chapter 893 in violation of s. 465.0276.
  399         10.Promoting or advertising through any communication
  400  medium the use, sale, or dispensing of a controlled substance
  401  appearing on any schedule in chapter 893.
  402         (2) The board may enter an order denying licensure or
  403  imposing any of the penalties in s. 456.072(2) against any
  404  applicant for licensure or licensee who is found guilty of
  405  violating any provision of subsection (1) of this section or who
  406  is found guilty of violating any provision of s. 456.072(1).
  408  ================= T I T L E  A M E N D M E N T ================
  409  And the title is amended as follows:
  410         Delete lines 908 - 952
  411  and insert:
  412         standards of practice; providing applicability;
  413         amending s. 458.326, F.S.; defining the term
  414         “interventional pain medicine”; restricting the
  415         practice of interventional pain medicine to specified
  416         circumstances; amending ss. 458.3265 and 459.0137,
  417         F.S.; limiting the authority to prescribe a controlled
  418         substance in a pain-management clinic to a physician
  419         licensed under ch. 458 or ch. 459, F.S.; amending s.
  420         458.347, F.S.; revising the required continuing
  421         education requirements for a physician assistant;
  422         amending s. 458.347, F.S.; requiring the Council of
  423         Physician Assistants to create a formulary which
  424         includes the controlled substances a physician
  425         assistant is authorized to prescribe; amending s.
  426         464.003, F.S.; redefining the term “advanced or
  427         specialized nursing practice”; removing the joint
  428         committee established in the definition; amending s.
  429         464.012, F.S.; requiring the Board of Nursing to
  430         establish a committee to make recommendations
  431         regarding the need for adoption of a formulary of
  432         controlled substances that may be prescribed by an
  433         advanced registered nurse practitioner; specifying the
  434         membership of the committee; providing parameters for
  435         the recommendations of the committee; requiring that
  436         any formulary be adopted by board rule; specifying the
  437         process for amending the formulary and imposing a
  438         burden of proof; limiting the formulary’s application
  439         in certain instances; requiring the board to adopt the
  440         committee’s initial recommendations by a specified
  441         date; amending s. 464.012, F.S.; authorizing an
  442         advanced registered nurse practitioner to prescribe,
  443         dispense, administer, or order drugs, rather than to
  444         monitor and alter drug therapies; providing an
  445         exception; amending s. 464.013, F.S.; revising
  446         conditions for renewal of a license or certificate;
  447         amending s. 464.018, F.S.; specifying acts that
  448         constitute grounds for denial of a license or for
  449         disciplinary action against an advanced registered
  450         nurse practitioner;