Florida Senate - 2013                        COMMITTEE AMENDMENT
       Bill No. SB 1192
       
       
       
       
       
       
                                Barcode 769960                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  03/20/2013           .                                
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       The Committee on Health Policy (Grimsley) recommended the
       following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 400.996, Florida Statutes, is created to
    6  read:
    7         400.996 Preemption.—This chapter preempts to the state all
    8  regulation of the licensure, activity, and operation of clinics
    9  under part X of chapter 400, excluding registration and
   10  licensing for pain-management clinics. A local government or
   11  political subdivision of the state may not enact or enforce an
   12  ordinance that imposes a levy, charge, or fee upon, or that
   13  otherwise regulates, clinics under part X of chapter 400,
   14  including services provided within such facilities, except that
   15  this preemption does not prohibit a local government or
   16  political subdivision from enacting an ordinance regarding the
   17  following:
   18         (1) Local business taxes adopted pursuant to chapter 205.
   19         (2) Land use development regulations adopted pursuant to
   20  chapter 163, which include regulation of any aspect of
   21  development, including a subdivision, building construction,
   22  sign regulation, and any other regulation concerning the
   23  development of land, landscaping, or tree protection, and which
   24  do not include restrictions on pain-management services, health
   25  care services, or the prescribing of controlled substances.
   26  However, a clinic that treats pain or provides pain-management
   27  services is a permissible use in a land use or zoning category
   28  that permits hospitals, other health care facilities, or clinics
   29  as defined in chapter 395, s. 408.07, or part X of chapter 400.
   30         Section 2. Section 408.833, Florida Statutes, is created to
   31  read:
   32         408.833Preemption.—This chapter preempts to the state all
   33  regulation of the licensure, activity, and operation of health
   34  care facilities as defined in s. 408.07. A local government or
   35  political subdivision of the state may not enact or enforce an
   36  ordinance that imposes a levy, charge, or fee upon, or that
   37  otherwise regulates health care facilities as defined in s.
   38  408.07, including services provided within such facilities,
   39  except that this preemption does not prohibit a local government
   40  or political subdivision from enacting an ordinance regarding
   41  the following:
   42         (1) Local business taxes adopted pursuant to chapter 205.
   43         (2) Land use development regulations adopted pursuant to
   44  chapter 163, which include regulation of any aspect of
   45  development, including a subdivision, building construction,
   46  sign regulation, and any other regulation concerning the
   47  development of land, landscaping, or tree protection, and which
   48  do not include restrictions on pain-management services, health
   49  care services, or the prescribing of controlled substances.
   50  However, a health care facility or clinic that treats pain or
   51  provides pain-management services is a permissible use in a land
   52  use or zoning category that permits hospitals, other health care
   53  facilities, or clinics as defined in chapter 395, s. 408.07, or
   54  part X of chapter 400.
   55         Section 3. Subsections (2) and (3) of section 456.44,
   56  Florida Statutes, are amended to read:
   57         456.44 Controlled substance prescribing.—
   58         (2) REGISTRATION.—Effective January 1, 2012, A physician
   59  licensed under chapter 458, chapter 459, chapter 461, or chapter
   60  466 who prescribes more than a 30-day supply of any controlled
   61  substance, listed in Schedule II, Schedule III, or Schedule IV
   62  as defined in s. 893.03, over a 6-month period to any one
   63  patient for the treatment of chronic nonmalignant pain, must:
   64         (a) Designate himself or herself as a controlled substance
   65  prescribing practitioner on the physician’s practitioner
   66  profile.
   67         (b) Comply with the requirements of this section and
   68  applicable board rules.
   69         (3) STANDARDS OF PRACTICE.—The standards of practice in
   70  this section do not supersede the level of care, skill, and
   71  treatment recognized in general law related to health care
   72  licensure.
   73         (a) A complete medical history and a physical examination
   74  must be conducted before beginning any treatment and must be
   75  documented in the medical record. The exact components of the
   76  physical examination shall be left to the judgment of the
   77  clinician who is expected to perform a physical examination
   78  proportionate to the diagnosis that justifies a treatment. The
   79  medical record must, at a minimum, document the nature and
   80  intensity of the pain, current and past treatments for pain,
   81  underlying or coexisting diseases or conditions, the effect of
   82  the pain on physical and psychological function, a review of
   83  previous medical records, previous diagnostic studies, and
   84  history of alcohol and substance abuse. The medical record shall
   85  also document the presence of one or more recognized medical
   86  indications for the use of a controlled substance. Each
   87  registrant must develop a written plan for assessing each
   88  patient’s risk of aberrant drug-related behavior, which may
   89  include patient drug testing. Registrants must assess each
   90  patient’s risk for aberrant drug-related behavior and monitor
   91  that risk on an ongoing basis in accordance with the plan.
   92         (b) Before or during a new patient’s visit for pain
   93  treatment services at a pain-management clinic registered under
   94  s. 458.3265 or s. 459.0137, a physician shall consult the
   95  prescription drug monitoring program database provided under s.
   96  893.055(2)(a) before prescribing a controlled substance listed
   97  in Schedule II or Schedule III in s. 893.03. The physician may
   98  designate an agent under his or her supervision to consult the
   99  database. The board shall adopt rules to establish a penalty for
  100  a physician who does not comply with this subsection.
  101         (c)(b) Each registrant must develop a written
  102  individualized treatment plan for each patient. The treatment
  103  plan shall state objectives that will be used to determine
  104  treatment success, such as pain relief and improved physical and
  105  psychosocial function, and shall indicate if any further
  106  diagnostic evaluations or other treatments are planned. After
  107  treatment begins, the physician shall adjust drug therapy to the
  108  individual medical needs of each patient. Other treatment
  109  modalities, including a rehabilitation program, shall be
  110  considered depending on the etiology of the pain and the extent
  111  to which the pain is associated with physical and psychosocial
  112  impairment. The interdisciplinary nature of the treatment plan
  113  shall be documented.
  114         (d)(c) The physician shall discuss the risks and benefits
  115  of the use of controlled substances, including the risks of
  116  abuse and addiction, as well as physical dependence and its
  117  consequences, with the patient, persons designated by the
  118  patient, or the patient’s surrogate or guardian if the patient
  119  is incompetent. The physician shall use a written controlled
  120  substance agreement between the physician and the patient
  121  outlining the patient’s responsibilities, including, but not
  122  limited to:
  123         1. Number and frequency of controlled substance
  124  prescriptions and refills.
  125         2. Patient compliance and reasons for which drug therapy
  126  may be discontinued, such as a violation of the agreement.
  127         3. An agreement that controlled substances for the
  128  treatment of chronic nonmalignant pain shall be prescribed by a
  129  single treating physician unless otherwise authorized by the
  130  treating physician and documented in the medical record.
  131         (e)(d) The patient shall be seen by the physician at
  132  regular intervals, not to exceed 3 months, to assess the
  133  efficacy of treatment, ensure that controlled substance therapy
  134  remains indicated, evaluate the patient’s progress toward
  135  treatment objectives, consider adverse drug effects, and review
  136  the etiology of the pain. Continuation or modification of
  137  therapy shall depend on the physician’s evaluation of the
  138  patient’s progress. If treatment goals are not being achieved,
  139  despite medication adjustments, the physician shall reevaluate
  140  the appropriateness of continued treatment. The physician shall
  141  monitor patient compliance in medication usage, related
  142  treatment plans, controlled substance agreements, and
  143  indications of substance abuse or diversion at a minimum of 3
  144  month intervals.
  145         (f)(e) The physician shall refer the patient as necessary
  146  for additional evaluation and treatment in order to achieve
  147  treatment objectives. Special attention shall be given to those
  148  patients who are at risk for misusing their medications and
  149  those whose living arrangements pose a risk for medication
  150  misuse or diversion. The management of pain in patients with a
  151  history of substance abuse or with a comorbid psychiatric
  152  disorder requires extra care, monitoring, and documentation and
  153  requires consultation with or referral to an addiction medicine
  154  specialist or psychiatrist.
  155         (g)(f) A physician registered under this section must
  156  maintain accurate, current, and complete records that are
  157  accessible and readily available for review and comply with the
  158  requirements of this section, the applicable practice act, and
  159  applicable board rules. The medical records must include, but
  160  are not limited to:
  161         1. The complete medical history and a physical examination,
  162  including history of drug abuse or dependence.
  163         2. Diagnostic, therapeutic, and laboratory results.
  164         3. Evaluations and consultations.
  165         4. Treatment objectives.
  166         5. Discussion of risks and benefits.
  167         6. Treatments.
  168         7. Medications, including date, type, dosage, and quantity
  169  prescribed.
  170         8. Instructions and agreements.
  171         9. Periodic reviews.
  172         10. Results of any drug testing.
  173         11. A photocopy of the patient’s government-issued photo
  174  identification.
  175         12. If a written prescription for a controlled substance is
  176  given to the patient, a duplicate of the prescription.
  177         13. The physician’s full name presented in a legible
  178  manner.
  179         (h)(g) Patients with signs or symptoms of substance abuse
  180  shall be immediately referred to a board-certified pain
  181  management physician, an addiction medicine specialist, or a
  182  mental health addiction facility as it pertains to drug abuse or
  183  addiction unless the physician is board-certified or board
  184  eligible in pain management. Throughout the period of time
  185  before receiving the consultant’s report, a prescribing
  186  physician shall clearly and completely document medical
  187  justification for continued treatment with controlled substances
  188  and those steps taken to ensure medically appropriate use of
  189  controlled substances by the patient. Upon receipt of the
  190  consultant’s written report, the prescribing physician shall
  191  incorporate the consultant’s recommendations for continuing,
  192  modifying, or discontinuing controlled substance therapy. The
  193  resulting changes in treatment shall be specifically documented
  194  in the patient’s medical record. Evidence or behavioral
  195  indications of diversion shall be followed by discontinuation of
  196  controlled substance therapy, and the patient shall be
  197  discharged, and all results of testing and actions taken by the
  198  physician shall be documented in the patient’s medical record.
  199  
  200  This subsection does not apply to a board-eligible or board
  201  certified anesthesiologist, physiatrist, rheumatologist, or
  202  neurologist, or to a board-certified physician who has surgical
  203  privileges at a hospital or ambulatory surgery center and
  204  primarily provides surgical services. This subsection does not
  205  apply to a board-eligible or board-certified medical specialist
  206  who has also completed a fellowship in pain medicine approved by
  207  the Accreditation Council for Graduate Medical Education or the
  208  American Osteopathic Association, or who is board eligible or
  209  board certified in pain medicine by the American Board of Pain
  210  Medicine or a board approved by the American Board of Medical
  211  Specialties or the American Osteopathic Association and performs
  212  interventional pain procedures of the type routinely billed
  213  using surgical codes. This subsection does not apply to a
  214  physician who prescribes medically necessary controlled
  215  substances for a patient during an inpatient stay in a hospital
  216  licensed under chapter 395 or to a resident in a facility
  217  licensed under part II of chapter 400. This subsection does not
  218  apply to any physician licensed under chapter 458 or chapter 459
  219  who writes fewer than 50 prescriptions for a controlled
  220  substance for all of his or her patients during a 1-year period.
  221         Section 4.  Subsection (3) of section 458.326, Florida
  222  Statutes, is amended to read:
  223         458.326 Intractable pain; authorized treatment.—
  224         (3)(a) Notwithstanding any other provision of law, a
  225  physician may prescribe or administer any controlled substance
  226  under Schedules II-V, as provided for in s. 893.03, to a person
  227  for the treatment of intractable pain, provided the physician
  228  does so in accordance with that level of care, skill, and
  229  treatment recognized by a reasonably prudent physician under
  230  similar conditions and circumstances.
  231         (b) Before or during a new patient’s visit for pain
  232  treatment services, a physician shall consult the prescription
  233  drug monitoring program database provided under s. 893.055(2)(a)
  234  before prescribing a controlled substance listed in Schedule II
  235  or Schedule III in s. 893.03. The physician may designate an
  236  agent under his or her supervision to consult the database. The
  237  board shall adopt rules to establish a penalty for a physician
  238  who does not comply with this paragraph.
  239         Section 5. Paragraphs (a) and (d) of subsection (1) of
  240  section 458.3265, Florida Statutes, are amended, present
  241  subsections (5) and (6) of that section are renumbered as
  242  subsections (6) and (7), respectively, and a new subsection (5)
  243  is added to that section, to read:
  244         458.3265 Pain-management clinics.—
  245         (1) REGISTRATION.—
  246         (a)1. As used in this section, the term:
  247         a. “Board eligible” means successful completion of an
  248  anesthesia, physical medicine and rehabilitation, rheumatology,
  249  or neurology residency program approved by the Accreditation
  250  Council for Graduate Medical Education or the American
  251  Osteopathic Association for a period of 6 years from successful
  252  completion of such residency program.
  253         b. “Chronic nonmalignant pain” means pain unrelated to
  254  cancer which persists beyond the usual course of disease or the
  255  injury that is the cause of the pain or more than 90 days after
  256  surgery.
  257         c. “Pain-management clinic” or “clinic” means any publicly
  258  or privately owned facility:
  259         (I) That advertises in any medium for any type of pain
  260  management services; or
  261         (II) Where in any month a majority of patients are
  262  prescribed opioids, benzodiazepines, barbiturates, or
  263  carisoprodol for the treatment of chronic nonmalignant pain.
  264         2. Each pain-management clinic must register with the
  265  department unless:
  266         a. That clinic is licensed as a facility pursuant to
  267  chapter 395;
  268         b. The majority of the physicians who provide services in
  269  the clinic primarily provide surgical services;
  270         c. The clinic is owned by a publicly held corporation whose
  271  shares are traded on a national exchange or on the over-the
  272  counter market and whose total assets at the end of the
  273  corporation’s most recent fiscal quarter exceeded $50 million;
  274         c.d. The clinic is affiliated with an accredited medical
  275  school at which training is provided for medical students,
  276  residents, or fellows;
  277         d.e. The clinic does not prescribe controlled substances
  278  for the treatment of pain;
  279         f. The clinic is owned by a corporate entity exempt from
  280  federal taxation under 26 U.S.C. s. 501(c)(3);
  281         e.g. The clinic is wholly owned and operated by one or more
  282  board-eligible or board-certified anesthesiologists,
  283  physiatrists, rheumatologists, or neurologists; or
  284         f.h. The clinic is wholly owned and operated by a physician
  285  multispecialty practice where one or more board-eligible or
  286  board-certified medical specialists who have also completed
  287  fellowships in pain medicine approved by the Accreditation
  288  Council for Graduate Medical Education, or who are also board
  289  certified in pain medicine by the American Board of Pain
  290  Medicine or a board approved by the American Board of Medical
  291  Specialties, the American Association of Physician Specialists,
  292  or the American Osteopathic Association and perform
  293  interventional pain procedures of the type routinely billed
  294  using surgical codes.
  295         (d) The department shall deny registration to any clinic
  296  that is not fully owned by a physician licensed under this
  297  chapter or chapter 459 or a group of physicians, each of whom is
  298  licensed under this chapter or chapter 459; or that is not a
  299  health care clinic licensed under part X of chapter 400 which is
  300  fully owned by such physician or group of physicians.
  301         (5) PREEMPTION.—This chapter preempts to the state all
  302  regulation of the licensure and activity of a physician licensed
  303  under this chapter who owns, operates, or works in a pain
  304  management clinic or provides pain-management services. A local
  305  government or political subdivision of the state may not enact
  306  or enforce an ordinance that imposes a levy, charge, or fee
  307  upon, or that otherwise regulates, a physician licensed under
  308  this chapter who owns, operates, or works in a pain-management
  309  clinic or provides pain-management services, except that this
  310  preemption does not prohibit a local government or political
  311  subdivision from enacting an ordinance regarding the following:
  312         (a) A registered pain-management clinic as defined in
  313  subsection (1).
  314         (b) Local business taxes adopted pursuant to chapter 205.
  315         (c) Land use development regulations adopted pursuant to
  316  chapter 163, which include regulation of any aspect of
  317  development, including a subdivision, building construction,
  318  sign regulation, and any other regulation concerning the
  319  development of land, landscaping, or tree protection, and which
  320  do not include restrictions on pain-management services, health
  321  care services, or the prescribing of controlled substances.
  322  However, a health care facility or clinic that treats pain or
  323  provides pain-management services is a permissible use in a land
  324  use or zoning category that permits hospitals, other health care
  325  facilities, or clinics as defined in chapter 395, s. 408.07, or
  326  part X of chapter 400.
  327         Section 6. Paragraphs (a) and (d) of subsection (1) of
  328  section 459.0137, Florida Statutes, are amended, present
  329  subsections (5) and (6) of that section are renumbered as
  330  subsections (6) and (7), respectively, and a new subsection (5)
  331  is added to that section, to read:
  332         459.0137 Pain-management clinics.—
  333         (1) REGISTRATION.—
  334         (a)1. As used in this section, the term:
  335         a. “Board eligible” means successful completion of an
  336  anesthesia, physical medicine and rehabilitation, rheumatology,
  337  or neurology residency program approved by the Accreditation
  338  Council for Graduate Medical Education or the American
  339  Osteopathic Association for a period of 6 years from successful
  340  completion of such residency program.
  341         b. “Chronic nonmalignant pain” means pain unrelated to
  342  cancer which persists beyond the usual course of disease or the
  343  injury that is the cause of the pain or more than 90 days after
  344  surgery.
  345         c. “Pain-management clinic” or “clinic” means any publicly
  346  or privately owned facility:
  347         (I) That advertises in any medium for any type of pain
  348  management services; or
  349         (II) Where in any month a majority of patients are
  350  prescribed opioids, benzodiazepines, barbiturates, or
  351  carisoprodol for the treatment of chronic nonmalignant pain.
  352         2. Each pain-management clinic must register with the
  353  department unless:
  354         a. That clinic is licensed as a facility pursuant to
  355  chapter 395;
  356         b. The majority of the physicians who provide services in
  357  the clinic primarily provide surgical services;
  358         c. The clinic is owned by a publicly held corporation whose
  359  shares are traded on a national exchange or on the over-the
  360  counter market and whose total assets at the end of the
  361  corporation’s most recent fiscal quarter exceeded $50 million;
  362         c.d. The clinic is affiliated with an accredited medical
  363  school at which training is provided for medical students,
  364  residents, or fellows;
  365         d.e. The clinic does not prescribe controlled substances
  366  for the treatment of pain;
  367         f. The clinic is owned by a corporate entity exempt from
  368  federal taxation under 26 U.S.C. s. 501(c)(3);
  369         e.g. The clinic is wholly owned and operated by one or more
  370  board-eligible or board-certified anesthesiologists,
  371  physiatrists, rheumatologists, or neurologists; or
  372         f.h. The clinic is wholly owned and operated by a physician
  373  multispecialty practice where one or more board-eligible or
  374  board-certified medical specialists who have also completed
  375  fellowships in pain medicine approved by the Accreditation
  376  Council for Graduate Medical Education or the American
  377  Osteopathic Association, or who are also board-certified in pain
  378  medicine by the American Board of Pain Medicine or a board
  379  approved by the American Board of Medical Specialties, the
  380  American Association of Physician Specialists, or the American
  381  Osteopathic Association and perform interventional pain
  382  procedures of the type routinely billed using surgical codes.
  383         (d) The department shall deny registration to any clinic
  384  that is not fully owned by a physician licensed under chapter
  385  458 or this chapter or a group of physicians, each of whom is
  386  licensed under chapter 458 or this chapter; or that is not a
  387  health care clinic licensed under part X of chapter 400 which is
  388  fully owned by such physician or group of physicians.
  389         (5) PREEMPTION.—This chapter preempts to the state all
  390  regulation of the licensure and activity of an osteopathic
  391  physician licensed under this chapter who owns, operates, or
  392  works in a pain-management clinic or provides pain-management
  393  services. A local government or political subdivision of the
  394  state may not enact or enforce an ordinance that imposes a levy,
  395  charge, or fee upon, or that otherwise regulates, an osteopathic
  396  physician licensed under this chapter who owns, operates, or
  397  works in a pain-management clinic, except that this preemption
  398  does not prohibit a local government or political subdivision
  399  from enacting an ordinance regarding the following:
  400         (a) A registered pain-management clinic as defined in
  401  subsection (1).
  402         (b) Local business taxes adopted pursuant to chapter 205.
  403         (c) Land use development regulations adopted pursuant to
  404  chapter 163, which include regulation of any aspect of
  405  development, including a subdivision, building construction,
  406  sign regulation, and any other regulation concerning the
  407  development of land, landscaping, or tree protection, and which
  408  do not include restrictions on pain-management services, health
  409  care services, and the prescribing of controlled substances.
  410  However, a health care facility or clinic that treats pain or
  411  provides pain-management services is a permissible use in a land
  412  use or zoning category that permits hospitals, other health care
  413  facilities, or clinics as defined in chapter 395, s. 408.07, or
  414  part X of chapter 400.
  415         Section 7. Present subsections (1) through (17) of section
  416  465.003, Florida Statutes, are renumbered as subsections (2)
  417  through (18), respectively, paragraph (a) of present subsection
  418  (11) of that section is amended, and a new subsection (1) is
  419  added to that section, to read:
  420         465.003 Definitions.—As used in this chapter, the term:
  421         (1) “Abandoned” means the status of a pharmacy permit of a
  422  person or entity that was issued the permit but fails to
  423  commence pharmacy operations within 180 days after issuance of
  424  the permit without good cause or fails to follow pharmacy
  425  closure requirements as set by the board.
  426         (12)(11)(a) “Pharmacy” includes a community pharmacy, an
  427  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
  428  and an Internet pharmacy.
  429         1. The term “community pharmacy” includes every location
  430  where medicinal drugs are compounded, dispensed, stored, or sold
  431  or where prescriptions are filled or dispensed on an outpatient
  432  basis.
  433         2. The term “institutional pharmacy” includes every
  434  location in a hospital, clinic, nursing home, dispensary,
  435  sanitarium, extended care facility, or other facility,
  436  hereinafter referred to as “health care institutions,” where
  437  medicinal drugs are compounded, dispensed, stored, or sold.
  438         3. The term “nuclear pharmacy” includes every location
  439  where radioactive drugs and chemicals within the classification
  440  of medicinal drugs are compounded, dispensed, stored, or sold.
  441  The term “nuclear pharmacy” does not include hospitals licensed
  442  under chapter 395 or the nuclear medicine facilities of such
  443  hospitals.
  444         4. The term “special pharmacy” includes every location
  445  where medicinal drugs are compounded, dispensed, stored, or sold
  446  if such locations are not otherwise defined in this subsection.
  447         5. The term “Internet pharmacy” includes locations not
  448  otherwise licensed or issued a permit under this chapter, within
  449  or outside this state, which use the Internet to communicate
  450  with or obtain information from consumers in this state and use
  451  such communication or information to fill or refill
  452  prescriptions or to dispense, distribute, or otherwise engage in
  453  the practice of pharmacy in this state. Any act described in
  454  this definition constitutes the practice of pharmacy as defined
  455  in subsection (14)(13).
  456         Section 8. Section 465.0065, Florida Statutes, is created
  457  to read:
  458         465.0065 Notices; form and service.—Each notice served by
  459  the department pursuant to this chapter must be in writing and
  460  must be delivered personally by an agent of the department or by
  461  certified mail to the pharmacy permittee or licensee. If the
  462  pharmacy permittee or licensee refuses to accept service or
  463  evades service or if the agent is otherwise unable to carry out
  464  service after due diligence, the department may post the notice
  465  in a conspicuous place at the pharmacy or at the home or
  466  business address for the licensee.
  467         Section 9. Paragraphs (e) and (s) of subsection (1) of
  468  section 465.016, Florida Statutes, are amended, and paragraph
  469  (u) is added to that subsection to read:
  470         465.016 Disciplinary actions.—
  471         (1) The following acts constitute grounds for denial of a
  472  license or disciplinary action, as specified in s. 456.072(2):
  473         (e) Violating chapter 499; 21 U.S.C. ss. 301-392, known as
  474  the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et
  475  seq., known as the Comprehensive Drug Abuse Prevention and
  476  Control Act; or chapter 893 or rules adopted thereunder.
  477         (s) Dispensing any medicinal drug based upon a
  478  communication that purports to be a prescription as defined by
  479  s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
  480  or has reason to believe that the purported prescription is not
  481  based upon a valid practitioner-patient relationship.
  482         (u) Misappropriating drugs, supplies, or equipment from a
  483  pharmacy permittee.
  484         Section 10. Paragraph (j) of subsection (5) of section
  485  465.022, Florida Statutes, is amended, present subsections (10)
  486  through (14) are renumbered as subsections (11) through (15),
  487  respectively, present subsection (10) of that section is
  488  amended, and a new subsection (10) is added to that section, to
  489  read:
  490         465.022 Pharmacies; general requirements; fees.—
  491         (5) The department or board shall deny an application for a
  492  pharmacy permit if the applicant or an affiliated person,
  493  partner, officer, director, or prescription department manager
  494  or consultant pharmacist of record of the applicant:
  495         (j) Has dispensed any medicinal drug based upon a
  496  communication that purports to be a prescription as defined by
  497  s. 465.003 s. 465.003(14) or s. 893.02 when the pharmacist knows
  498  or has reason to believe that the purported prescription is not
  499  based upon a valid practitioner-patient relationship that
  500  includes a documented patient evaluation, including history and
  501  a physical examination adequate to establish the diagnosis for
  502  which any drug is prescribed and any other requirement
  503  established by board rule under chapter 458, chapter 459,
  504  chapter 461, chapter 463, chapter 464, or chapter 466.
  505  
  506  For felonies in which the defendant entered a plea of guilty or
  507  nolo contendere in an agreement with the court to enter a
  508  pretrial intervention or drug diversion program, the department
  509  shall deny the application if upon final resolution of the case
  510  the licensee has failed to successfully complete the program.
  511         (10) The permittee shall commence pharmacy operations
  512  within 180 days after issuance of the permit, or show good cause
  513  to the department why pharmacy operations were not commenced.
  514  Commencement of pharmacy operations includes, but is not limited
  515  to, acts within the scope of the practice of pharmacy, ordering
  516  or receiving drugs, and other similar activities. The board
  517  shall establish rules regarding commencement of pharmacy
  518  operations.
  519         (11)(10)A pharmacy permittee shall be supervised by a
  520  prescription department manager or consultant pharmacist of
  521  record at all times. A permittee must notify the department, on
  522  a form approved by the board, within 10 days after any change in
  523  prescription department manager or consultant pharmacist of
  524  record.
  525         Section 11. Subsection (1) of section 465.023, Florida
  526  Statutes, is amended to read:
  527         465.023 Pharmacy permittee; disciplinary action.—
  528         (1) The department or the board may revoke or suspend the
  529  permit of any pharmacy permittee, and may fine, place on
  530  probation, or otherwise discipline any pharmacy permittee if the
  531  permittee, or any affiliated person, partner, officer, director,
  532  or agent of the permittee, including a person fingerprinted
  533  under s. 465.022(3), has:
  534         (a) Obtained a permit by misrepresentation or fraud or
  535  through an error of the department or the board;
  536         (b) Attempted to procure, or has procured, a permit for any
  537  other person by making, or causing to be made, any false
  538  representation;
  539         (c) Violated any of the requirements of this chapter or any
  540  of the rules of the Board of Pharmacy; of chapter 499, known as
  541  the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392,
  542  known as the “Federal Food, Drug, and Cosmetic Act”; of 21
  543  U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse
  544  Prevention and Control Act; or of chapter 893 or rules adopted
  545  thereunder;
  546         (d) Been convicted or found guilty, regardless of
  547  adjudication, of a felony or any other crime involving moral
  548  turpitude in any of the courts of this state, of any other
  549  state, or of the United States;
  550         (e) Been convicted or disciplined by a regulatory agency of
  551  the Federal Government or a regulatory agency of another state
  552  for any offense that would constitute a violation of this
  553  chapter;
  554         (f) Been convicted of, or entered a plea of guilty or nolo
  555  contendere to, regardless of adjudication, a crime in any
  556  jurisdiction which relates to the practice of, or the ability to
  557  practice, the profession of pharmacy;
  558         (g) Been convicted of, or entered a plea of guilty or nolo
  559  contendere to, regardless of adjudication, a crime in any
  560  jurisdiction which relates to health care fraud; or
  561         (h) Dispensed any medicinal drug based upon a communication
  562  that purports to be a prescription as defined by s. 465.003 s.
  563  465.003(14) or s. 893.02 when the pharmacist knows or has reason
  564  to believe that the purported prescription is not based upon a
  565  valid practitioner-patient relationship that includes a
  566  documented patient evaluation, including history and a physical
  567  examination adequate to establish the diagnosis for which any
  568  drug is prescribed and any other requirement established by
  569  board rule under chapter 458, chapter 459, chapter 461, chapter
  570  463, chapter 464, or chapter 466.
  571         Section 12. Section 465.1902, Florida Statutes, is created
  572  to read:
  573         465.1902Preemption.—This chapter preempts to the state all
  574  regulation of the licensure, activity, and operation of
  575  pharmacies and pharmacists as defined in this chapter. A local
  576  government or political subdivision of the state may not enact
  577  or enforce an ordinance that imposes a levy, charge, or fee
  578  upon, or that otherwise regulates, pharmacies and pharmacists as
  579  defined in this chapter, except that this preemption does not
  580  prohibit a local government or political subdivision from
  581  enacting an ordinance regarding the following:
  582         (1) Local business taxes adopted pursuant to chapter 205.
  583         (2) Land use development regulations adopted pursuant to
  584  chapter 163, which include regulation of any aspect of
  585  development, including a subdivision, building construction,
  586  sign regulation, and any other regulation concerning the
  587  development of land, landscaping, or tree protection, and which
  588  do not include restrictions on pain-management services, health
  589  care services, or the prescribing of controlled substances.
  590         Section 13. Paragraph (b) of subsection (2), subsection
  591  (10), and paragraph (c) of subsection (11) of section 893.055,
  592  Florida Statutes, are amended to read:
  593         893.055 Prescription drug monitoring program.—
  594         (2)
  595         (b) The department, when the direct support organization
  596  receives at least $20,000 in nonstate moneys or the state
  597  receives at least $20,000 in federal grants for the prescription
  598  drug monitoring program, shall adopt rules as necessary
  599  concerning the reporting, accessing the database, evaluation,
  600  management, development, implementation, operation, security,
  601  and storage of information within the system, including rules
  602  for when patient advisory reports are provided to pharmacies and
  603  prescribers. The patient advisory report shall be provided in
  604  accordance with s. 893.13(7)(a)8. The department shall work with
  605  the professional health care licensure boards, such as the Board
  606  of Medicine, the Board of Osteopathic Medicine, and the Board of
  607  Pharmacy; other appropriate organizations, such as the Florida
  608  Pharmacy Association, the Florida Medical Association, the
  609  Florida Retail Federation, and the Florida Osteopathic Medical
  610  Association, including those relating to pain management; and
  611  the Attorney General, the Department of Law Enforcement, and the
  612  Agency for Health Care Administration to develop rules
  613  appropriate for the prescription drug monitoring program.
  614         (10) All costs incurred by the department in administering
  615  the prescription drug monitoring program shall be funded through
  616  state funds, federal grants, or private funding applied for or
  617  received by the state. The department may not commit funds for
  618  the monitoring program without ensuring funding is available.
  619  The prescription drug monitoring program and the implementation
  620  thereof are contingent upon receipt of the nonstate funding. The
  621  department and state government shall cooperate with the direct
  622  support organization established pursuant to subsection (11) in
  623  seeking state funds, federal grant funds, other nonstate grant
  624  funds, gifts, donations, or other private moneys for the
  625  department if so long as the costs of doing so are not
  626  considered material. Nonmaterial costs for this purpose include,
  627  but are not limited to, the costs of mailing and personnel
  628  assigned to research or apply for a grant. Notwithstanding the
  629  exemptions to competitive-solicitation requirements under s.
  630  287.057(3)(f), the department shall comply with the competitive
  631  solicitation requirements under s. 287.057 for the procurement
  632  of any goods or services required by this section. Funds
  633  provided, directly or indirectly, by prescription drug
  634  manufacturers may not be used to implement the program.
  635         (11) The department may establish a direct-support
  636  organization that has a board consisting of at least five
  637  members to provide assistance, funding, and promotional support
  638  for the activities authorized for the prescription drug
  639  monitoring program.
  640         (c) The State Surgeon General shall appoint a board of
  641  directors for the direct-support organization. Members of the
  642  board shall serve at the pleasure of the State Surgeon General.
  643  The State Surgeon General shall provide guidance to members of
  644  the board to ensure that moneys received by the direct-support
  645  organization are not received from inappropriate sources.
  646  Inappropriate sources include, but are not limited to, donors,
  647  grantors, persons, and or organizations, excluding
  648  pharmaceutical companies, that may monetarily or substantively
  649  benefit from the purchase of goods or services by the department
  650  in furtherance of the prescription drug monitoring program.
  651         Section 14. Subsection (1) of section 409.9201, Florida
  652  Statutes, is amended to read:
  653         409.9201 Medicaid fraud.—
  654         (1) As used in this section, the term:
  655         (a) “Prescription drug” means any drug, including, but not
  656  limited to, finished dosage forms or active ingredients that are
  657  subject to, defined by, or described by s. 503(b) of the Federal
  658  Food, Drug, and Cosmetic Act or by s. 465.003 s. 465.003(8), s.
  659  499.003(46) or (53) or s. 499.007(13).
  660         (b) “Value” means the amount billed to the Medicaid program
  661  for the property dispensed or the market value of a legend drug
  662  or goods or services at the time and place of the offense. If
  663  the market value cannot be determined, the term means the
  664  replacement cost of the legend drug or goods or services within
  665  a reasonable time after the offense.
  666  
  667  The value of individual items of the legend drugs or goods or
  668  services involved in distinct transactions committed during a
  669  single scheme or course of conduct, whether involving a single
  670  person or several persons, may be aggregated when determining
  671  the punishment for the offense.
  672         Section 15. Paragraph (pp) of subsection (1) of section
  673  458.331, Florida Statutes, is amended to read:
  674         458.331 Grounds for disciplinary action; action by the
  675  board and department.—
  676         (1) The following acts constitute grounds for denial of a
  677  license or disciplinary action, as specified in s. 456.072(2):
  678         (pp) Applicable to a licensee who serves as the designated
  679  physician of a pain-management clinic as defined in s. 458.3265
  680  or s. 459.0137:
  681         1. Registering a pain-management clinic through
  682  misrepresentation or fraud;
  683         2. Procuring, or attempting to procure, the registration of
  684  a pain-management clinic for any other person by making or
  685  causing to be made, any false representation;
  686         3. Failing to comply with any requirement of chapter 499,
  687  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  688  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  689  the Drug Abuse Prevention and Control Act; or chapter 893, the
  690  Florida Comprehensive Drug Abuse Prevention and Control Act;
  691         4. Being convicted or found guilty of, regardless of
  692  adjudication to, a felony or any other crime involving moral
  693  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  694  the courts of this state, of any other state, or of the United
  695  States;
  696         5. Being convicted of, or disciplined by a regulatory
  697  agency of the Federal Government or a regulatory agency of
  698  another state for, any offense that would constitute a violation
  699  of this chapter;
  700         6. Being convicted of, or entering a plea of guilty or nolo
  701  contendere to, regardless of adjudication, a crime in any
  702  jurisdiction of the courts of this state, of any other state, or
  703  of the United States which relates to the practice of, or the
  704  ability to practice, a licensed health care profession;
  705         7. Being convicted of, or entering a plea of guilty or nolo
  706  contendere to, regardless of adjudication, a crime in any
  707  jurisdiction of the courts of this state, of any other state, or
  708  of the United States which relates to health care fraud;
  709         8. Dispensing any medicinal drug based upon a communication
  710  that purports to be a prescription as defined in s. 465.003 s.
  711  465.003(14) or s. 893.02 if the dispensing practitioner knows or
  712  has reason to believe that the purported prescription is not
  713  based upon a valid practitioner-patient relationship; or
  714         9. Failing to timely notify the board of the date of his or
  715  her termination from a pain-management clinic as required by s.
  716  458.3265(2).
  717         Section 16. Paragraph (rr) of subsection (1) of section
  718  459.015, Florida Statutes, is amended to read:
  719         459.015 Grounds for disciplinary action; action by the
  720  board and department.—
  721         (1) The following acts constitute grounds for denial of a
  722  license or disciplinary action, as specified in s. 456.072(2):
  723         (rr) Applicable to a licensee who serves as the designated
  724  physician of a pain-management clinic as defined in s. 458.3265
  725  or s. 459.0137:
  726         1. Registering a pain-management clinic through
  727  misrepresentation or fraud;
  728         2. Procuring, or attempting to procure, the registration of
  729  a pain-management clinic for any other person by making or
  730  causing to be made, any false representation;
  731         3. Failing to comply with any requirement of chapter 499,
  732  the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
  733  Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
  734  the Drug Abuse Prevention and Control Act; or chapter 893, the
  735  Florida Comprehensive Drug Abuse Prevention and Control Act;
  736         4. Being convicted or found guilty of, regardless of
  737  adjudication to, a felony or any other crime involving moral
  738  turpitude, fraud, dishonesty, or deceit in any jurisdiction of
  739  the courts of this state, of any other state, or of the United
  740  States;
  741         5. Being convicted of, or disciplined by a regulatory
  742  agency of the Federal Government or a regulatory agency of
  743  another state for, any offense that would constitute a violation
  744  of this chapter;
  745         6. Being convicted of, or entering a plea of guilty or nolo
  746  contendere to, regardless of adjudication, a crime in any
  747  jurisdiction of the courts of this state, of any other state, or
  748  of the United States which relates to the practice of, or the
  749  ability to practice, a licensed health care profession;
  750         7. Being convicted of, or entering a plea of guilty or nolo
  751  contendere to, regardless of adjudication, a crime in any
  752  jurisdiction of the courts of this state, of any other state, or
  753  of the United States which relates to health care fraud;
  754         8. Dispensing any medicinal drug based upon a communication
  755  that purports to be a prescription as defined in s. 465.003 s.
  756  465.003(14) or s. 893.02 if the dispensing practitioner knows or
  757  has reason to believe that the purported prescription is not
  758  based upon a valid practitioner-patient relationship; or
  759         9. Failing to timely notify the board of the date of his or
  760  her termination from a pain-management clinic as required by s.
  761  459.0137(2).
  762         Section 17. Subsection (1) of section 465.014, Florida
  763  Statutes, is amended to read:
  764         465.014 Pharmacy technician.—
  765         (1) A person other than a licensed pharmacist or pharmacy
  766  intern may not engage in the practice of the profession of
  767  pharmacy, except that a licensed pharmacist may delegate to
  768  pharmacy technicians who are registered pursuant to this section
  769  those duties, tasks, and functions that do not fall within the
  770  purview of s. 465.003 s. 465.003(13). All such delegated acts
  771  shall be performed under the direct supervision of a licensed
  772  pharmacist who shall be responsible for all such acts performed
  773  by persons under his or her supervision. A pharmacy registered
  774  technician, under the supervision of a pharmacist, may initiate
  775  or receive communications with a practitioner or his or her
  776  agent, on behalf of a patient, regarding refill authorization
  777  requests. A licensed pharmacist may not supervise more than one
  778  registered pharmacy technician unless otherwise permitted by the
  779  guidelines adopted by the board. The board shall establish
  780  guidelines to be followed by licensees or permittees in
  781  determining the circumstances under which a licensed pharmacist
  782  may supervise more than one but not more than three pharmacy
  783  technicians.
  784         Section 18. Paragraph (c) of subsection (2) of section
  785  465.015, Florida Statutes, is amended to read:
  786         465.015 Violations and penalties.—
  787         (2) It is unlawful for any person:
  788         (c) To sell or dispense drugs as defined in s. 465.003 s.
  789  465.003(8) without first being furnished with a prescription.
  790         Section 19. Subsection (8) of section 465.0156, Florida
  791  Statutes, is amended to read:
  792         465.0156 Registration of nonresident pharmacies.—
  793         (8) Notwithstanding s. 465.003 s. 465.003(10), for purposes
  794  of this section, the registered pharmacy and the pharmacist
  795  designated by the registered pharmacy as the prescription
  796  department manager or the equivalent must be licensed in the
  797  state of location in order to dispense into this state.
  798         Section 20. Subsection (4) of section 465.0197, Florida
  799  Statutes, is amended to read:
  800         465.0197 Internet pharmacy permits.—
  801         (4) Notwithstanding s. 465.003 s. 465.003(10), for purposes
  802  of this section, the Internet pharmacy and the pharmacist
  803  designated by the Internet pharmacy as the prescription
  804  department manager or the equivalent must be licensed in the
  805  state of location in order to dispense into this state.
  806         Section 21. Section 465.1901, Florida Statutes, is amended
  807  to read:
  808         465.1901 Practice of orthotics and pedorthics.—The
  809  provisions of chapter 468 relating to orthotics or pedorthics do
  810  not apply to any licensed pharmacist or to any person acting
  811  under the supervision of a licensed pharmacist. The practice of
  812  orthotics or pedorthics by a pharmacist or any of the
  813  pharmacist’s employees acting under the supervision of a
  814  pharmacist shall be construed to be within the meaning of the
  815  term “practice of the profession of pharmacy” as set forth in s.
  816  465.003 s. 465.003(13), and shall be subject to regulation in
  817  the same manner as any other pharmacy practice. The Board of
  818  Pharmacy shall develop rules regarding the practice of orthotics
  819  and pedorthics by a pharmacist. Any pharmacist or person under
  820  the supervision of a pharmacist engaged in the practice of
  821  orthotics or pedorthics is not precluded from continuing that
  822  practice pending adoption of these rules.
  823         Section 22. Subsection (43) of section 499.003, Florida
  824  Statutes, is amended to read:
  825         499.003 Definitions of terms used in this part.—As used in
  826  this part, the term:
  827         (43) “Prescription drug” means a prescription, medicinal,
  828  or legend drug, including, but not limited to, finished dosage
  829  forms or active pharmaceutical ingredients subject to, defined
  830  by, or described by s. 503(b) of the Federal Food, Drug, and
  831  Cosmetic Act or s. 465.003 s. 465.003(8), s. 499.007(13), or
  832  subsection (11), subsection (46), or subsection (53), except
  833  that an active pharmaceutical ingredient is a prescription drug
  834  only if substantially all finished dosage forms in which it may
  835  be lawfully dispensed or administered in this state are also
  836  prescription drugs.
  837         Section 23. Subsection (22) of section 893.02, Florida
  838  Statutes, is amended to read:
  839         893.02 Definitions.—The following words and phrases as used
  840  in this chapter shall have the following meanings, unless the
  841  context otherwise requires:
  842         (22) “Prescription” means and includes an order for drugs
  843  or medicinal supplies written, signed, or transmitted by word of
  844  mouth, telephone, telegram, or other means of communication by a
  845  duly licensed practitioner licensed by the laws of the state to
  846  prescribe such drugs or medicinal supplies, issued in good faith
  847  and in the course of professional practice, intended to be
  848  filled, compounded, or dispensed by another person licensed by
  849  the laws of the state to do so, and meeting the requirements of
  850  s. 893.04. The term also includes an order for drugs or
  851  medicinal supplies so transmitted or written by a physician,
  852  dentist, veterinarian, or other practitioner licensed to
  853  practice in a state other than Florida, but only if the
  854  pharmacist called upon to fill such an order determines, in the
  855  exercise of his or her professional judgment, that the order was
  856  issued pursuant to a valid patient-physician relationship, that
  857  it is authentic, and that the drugs or medicinal supplies so
  858  ordered are considered necessary for the continuation of
  859  treatment of a chronic or recurrent illness. However, if the
  860  physician writing the prescription is not known to the
  861  pharmacist, the pharmacist shall obtain proof to a reasonable
  862  certainty of the validity of said prescription. A prescription
  863  order for a controlled substance shall not be issued on the same
  864  prescription blank with another prescription order for a
  865  controlled substance which is named or described in a different
  866  schedule, nor shall any prescription order for a controlled
  867  substance be issued on the same prescription blank as a
  868  prescription order for a medicinal drug, as defined in s.
  869  465.003 s. 465.003(8), which does not fall within the definition
  870  of a controlled substance as defined in this act.
  871         Section 24. This act shall take effect July 1, 2013.
  872  
  873  ================= T I T L E  A M E N D M E N T ================
  874         And the title is amended as follows:
  875         Delete everything before the enacting clause
  876  and insert:
  877                        A bill to be entitled                      
  878         An act relating to the provision of health care with
  879         controlled substances; creating ss. 400.996 and
  880         408.833, F.S.; providing that regulation of the
  881         licensure, activity, and operation of clinics and
  882         health care facilities is preempted to the state;
  883         prohibiting a local government or political
  884         subdivision of the state from enacting or enforcing an
  885         ordinance that imposes a levy, charge, or fee upon, or
  886         that otherwise regulates, clinics and health care
  887         facilities, except for ordinances regarding local
  888         business taxes and land development; amending s.
  889         456.44, F.S.; limiting the application of requirements
  890         for prescribing controlled substances; requiring a
  891         physician to consult the prescription drug monitoring
  892         program database before prescribing certain controlled
  893         substances; authorizing the board to adopt a penalty
  894         for failure to consult the database; exempting nursing
  895         home residents and certain physicians from
  896         requirements regarding prescriptions of controlled
  897         substances; amending s. 458.326, F.S.; requiring a
  898         physician to consult the prescription drug monitoring
  899         program database or designate an agent to consult the
  900         database before prescribing certain controlled
  901         substances; authorizing the board to adopt a penalty
  902         for failure to consult the database; amending ss.
  903         458.3265 and 459.0137, F.S.; requiring that owners of
  904         pain-management clinics be licensed physicians;
  905         removing language regarding nonphysician-owned pain
  906         management clinics; providing that regulation of the
  907         licensure and activity of certain physicians and
  908         osteopathic physicians is preempted to the state;
  909         prohibiting a local government or political
  910         subdivision of the state from enacting or enforcing an
  911         ordinance that imposes a levy, charge, or fee upon, or
  912         that otherwise regulates, physicians and osteopathic
  913         physicians, except for ordinances regarding local
  914         business taxes and land development; amending s.
  915         465.003, F.S.; defining a term; conforming a cross
  916         reference; creating s. 465.0065, F.S.; providing
  917         notice requirements for inspection of a pharmacy;
  918         amending s. 465.016, F.S.; providing additional
  919         grounds for disciplinary action; conforming a cross
  920         reference; amending s. 465.022, F.S.; conforming a
  921         cross-reference; requiring a pharmacy permittee to
  922         commence operations within 180 days after permit
  923         issuance or show good cause why operations were not
  924         commenced; requiring the board to establish rules;
  925         requiring a pharmacy permittee to be supervised by a
  926         prescription department manager or consultant
  927         pharmacist of record; amending s. 465.023, F.S.;
  928         providing additional grounds for disciplinary action;
  929         conforming a cross-reference; creating s. 465.1902,
  930         F.S.; providing that regulation of the licensure,
  931         activity, and operation of pharmacies and pharmacists
  932         is preempted to the state; prohibiting a local
  933         government or political subdivision of the state from
  934         enacting or enforcing an ordinance that imposes a
  935         levy, charge, or fee upon, or that otherwise
  936         regulates, pharmacies and pharmacists, except for
  937         ordinances regarding local business taxes and land
  938         development; amending s. 893.055, F.S.; deleting an
  939         obsolete provision; authorizing the prescription drug
  940         monitoring program to be funded by state funds and
  941         pharmaceutical company donations; amending ss.
  942         409.9201, 458.331, 459.015, 465.014, 465.015,
  943         465.0156, 465.0197, 465.1901, 499.003, and 893.02,
  944         F.S.; conforming cross-references; providing an
  945         effective date.