Florida Senate - 2012                          SENATOR AMENDMENT
       Bill No. CS/CS/HB 1175, 1st Eng.
       
       
       
       
       
       
                                Barcode 848474                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/RE/3R         .                                
             03/07/2012 12:04 PM       .                                
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       Senator Bogdanoff moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Between lines 20 and 21
    4  insert:
    5         Section 1. Section 456.44, Florida Statutes, is amended to
    6  read:
    7         456.44 Controlled substance prescribing.—
    8         (1) DEFINITIONS.—
    9         (a) “Addiction medicine specialist” means a board-certified
   10  psychiatrist who holds physiatrist with a subspecialty
   11  certification in addiction medicine or who is eligible for such
   12  subspecialty certification in addiction medicine, a an addiction
   13  medicine physician who is certified or eligible for
   14  certification by the American Board Society of Addiction
   15  Medicine, or an osteopathic physician who holds a certificate of
   16  added qualification in Addiction Medicine through the American
   17  Osteopathic Association.
   18         (b) “Adverse incident” means any incident set forth in s.
   19  458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
   20         (c) “Board–certified pain management physician” means a
   21  physician who possesses board certification in pain medicine by
   22  the American Board of Pain Medicine, board certification by the
   23  American Board of Interventional Pain Physicians, or board
   24  certification or subcertification in pain management or pain
   25  medicine by a specialty board recognized by the American
   26  Association of Physician Specialists or the American Board of
   27  Medical Specialties or an osteopathic physician who holds a
   28  certificate in Pain Management by the American Osteopathic
   29  Association.
   30         (d) “Chronic nonmalignant pain” means pain unrelated to
   31  cancer, or rheumatoid arthritis, or sickle cell anemia which
   32  persists beyond the usual course of disease or beyond the injury
   33  that is the cause of the pain or which persists more than 90
   34  days after surgery.
   35         (e) “Mental health addiction facility” means a facility
   36  licensed under chapter 394 or chapter 397.
   37         (2) REGISTRATION.—Effective January 1, 2012, a physician
   38  licensed under chapter 458, chapter 459, chapter 461, or chapter
   39  466 who prescribes any controlled substance listed in Schedule
   40  II, Schedule III, or Schedule IV, as defined in s. 893.03, over
   41  a 6-month period to any one patient for the treatment of chronic
   42  nonmalignant pain, must:
   43         (a) Designate himself or herself as a controlled substance
   44  prescribing practitioner on the physician’s practitioner
   45  profile.
   46         (b) Comply with the requirements of this section and
   47  applicable board rules.
   48         (3) STANDARDS OF PRACTICE.—The standards of practice in
   49  this section do not supersede the level of care, skill, and
   50  treatment recognized in general law related to health care
   51  licensure.
   52         (a) A complete medical history and a physical examination
   53  must be conducted before beginning any treatment and must be
   54  documented in the medical record. The exact components of the
   55  physical examination shall be left to the judgment of the
   56  clinician who is expected to perform a physical examination
   57  proportionate to the diagnosis that justifies a treatment. The
   58  medical record must, at a minimum, document the nature and
   59  intensity of the pain, current and past treatments for pain,
   60  underlying or coexisting diseases or conditions, the effect of
   61  the pain on physical and psychological function, a review of
   62  previous medical records, previous diagnostic studies, and
   63  history of alcohol and substance abuse. The medical record must
   64  shall also document the presence of one or more recognized
   65  medical indications for the use of a controlled substance. Each
   66  registrant must develop a written plan for assessing each
   67  patient’s risk of aberrant drug-related behavior, which may
   68  include patient drug testing. Registrants must assess each
   69  patient’s risk for aberrant drug-related behavior and monitor
   70  that risk on an ongoing basis in accordance with the plan.
   71         (b) Each registrant must develop a written individualized
   72  treatment plan for each patient. The treatment plan must shall
   73  state objectives that will be used to determine treatment
   74  success, such as pain relief and improved physical and
   75  psychosocial function, and must shall indicate if any further
   76  diagnostic evaluations or other treatments are planned. After
   77  treatment begins, the physician shall adjust drug therapy to the
   78  individual medical needs of each patient. Other treatment
   79  modalities, including a rehabilitation program, shall be
   80  considered depending on the etiology of the pain and the extent
   81  to which the pain is associated with physical and psychosocial
   82  impairment. The interdisciplinary nature of the treatment plan
   83  shall be documented.
   84         (c) The physician shall discuss the risks and benefits of
   85  the use of controlled substances, including the risks of abuse
   86  and addiction, as well as physical dependence and its
   87  consequences, with the patient, persons designated by the
   88  patient, or the patient’s surrogate or guardian if the patient
   89  is incompetent. The physician shall use a written controlled
   90  substance agreement between the physician and the patient
   91  outlining the patient’s responsibilities, including, but not
   92  limited to:
   93         1. Number and frequency of prescriptions and refills for
   94  controlled substances substance prescriptions and refills.
   95         2. Patient compliance and reasons for which drug therapy
   96  may be discontinued, such as a violation of the agreement.
   97         3. An agreement that controlled substances for the
   98  treatment of chronic nonmalignant pain shall be prescribed by a
   99  single treating physician unless otherwise authorized by the
  100  treating physician and documented in the medical record.
  101         (d) The patient shall be seen by the physician at regular
  102  intervals, not to exceed 3 months, to assess the efficacy of
  103  treatment, ensure that controlled-substance controlled substance
  104  therapy remains indicated, evaluate the patient’s progress
  105  toward treatment objectives, consider adverse drug effects, and
  106  review the etiology of the pain. Continuation or modification of
  107  therapy depends shall depend on the physician’s evaluation of
  108  the patient’s progress. If treatment goals are not being
  109  achieved, despite medication adjustments, the physician shall
  110  reevaluate the appropriateness of continued treatment. The
  111  physician shall monitor patient compliance in medication usage,
  112  related treatment plans, controlled substance agreements, and
  113  indications of substance abuse or diversion at a minimum of 3
  114  month intervals.
  115         (e) The physician shall refer the patient as necessary for
  116  additional evaluation and treatment in order to achieve
  117  treatment objectives. Special attention shall be given to those
  118  patients who are at risk for misusing their medications and
  119  those whose living arrangements pose a risk for medication
  120  misuse or diversion. The management of pain in patients with a
  121  history of substance abuse or with a comorbid psychiatric
  122  disorder requires extra care, monitoring, and documentation and
  123  requires consultation with or referral to an addiction medicine
  124  specialist addictionologist or psychiatrist physiatrist.
  125         (f) A physician registered under this section must maintain
  126  accurate, current, and complete records that are accessible and
  127  readily available for review and comply with the requirements of
  128  this section, the applicable practice act, and applicable board
  129  rules. The medical records must include, but are not limited to:
  130         1. The complete medical history and a physical examination,
  131  including history of drug abuse or dependence.
  132         2. Diagnostic, therapeutic, and laboratory results.
  133         3. Evaluations and consultations.
  134         4. Treatment objectives.
  135         5. Discussion of risks and benefits.
  136         6. Treatments.
  137         7. Medications, including date, type, dosage, and quantity
  138  prescribed.
  139         8. Instructions and agreements.
  140         9. Periodic reviews.
  141         10. Results of any drug testing.
  142         11. A photocopy of the patient’s government-issued photo
  143  identification.
  144         12. If a written prescription for a controlled substance is
  145  given to the patient, a duplicate of the prescription.
  146         13. The physician’s full name presented in a legible
  147  manner.
  148         (g) Patients with signs or symptoms of substance abuse
  149  shall be immediately referred to a board-certified pain
  150  management physician, an addiction medicine specialist, or a
  151  mental health addiction facility as it pertains to drug abuse or
  152  addiction unless the physician is board eligible or board
  153  certified board-certified or board-eligible in pain management.
  154  Throughout the period of time before receiving the consultant’s
  155  report, a prescribing physician shall clearly and completely
  156  document medical justification for continued treatment with
  157  controlled substances and those steps taken to ensure medically
  158  appropriate use of controlled substances by the patient. Upon
  159  receipt of the consultant’s written report, the prescribing
  160  physician shall incorporate the consultant’s recommendations for
  161  continuing, modifying, or discontinuing the controlled-substance
  162  controlled substance therapy. The resulting changes in treatment
  163  shall be specifically documented in the patient’s medical
  164  record. Evidence or behavioral indications of diversion shall be
  165  followed by discontinuation of the controlled-substance
  166  controlled substance therapy, and the patient shall be
  167  discharged, and all results of testing and actions taken by the
  168  physician shall be documented in the patient’s medical record.
  169         (h) When a pharmacy subject to this section receives a
  170  prescription, the prescription is deemed compliant with the
  171  standards of practice under this section and, therefore, valid
  172  for dispensing.
  173  
  174  This subsection does not apply to a board-eligible or board
  175  certified anesthesiologist, physiatrist, psychiatrist,
  176  rheumatologist, or neurologist, or to a board-certified
  177  physician who has surgical privileges at a hospital or
  178  ambulatory surgery center and primarily provides surgical
  179  services. This subsection does not apply to a board-eligible or
  180  board-certified medical specialist who has also completed a
  181  fellowship in pain medicine approved by the Accreditation
  182  Council for Graduate Medical Education or the American
  183  Osteopathic Association, or who is board eligible or board
  184  certified in pain medicine by a board approved by the American
  185  Board of Pain Medicine, the American Board of Medical
  186  Specialties, or the American Osteopathic Association and
  187  performs interventional pain procedures of the type routinely
  188  billed using surgical codes. This subsection does not apply to a
  189  physician certified by the American Board of Medical Specialties
  190  in hospice and palliative medicine or to an osteopathic
  191  physician who holds a certificate of added qualification in
  192  hospice and palliative medicine through the American Osteopathic
  193  Association. This subsection does not apply to a physician who
  194  prescribes medically necessary controlled substances for a
  195  patient during an inpatient stay or while providing emergency
  196  services and care in a hospital licensed under chapter 395. This
  197  subsection does not apply to a physician who treats a patient
  198  who is admitted in a nursing home or related health care
  199  facility or receiving hospice services as defined in chapter
  200  400. This subsection does not apply to a physician who treats a
  201  patient in accordance with an approved clinical trial. This
  202  subsection does not apply to a physician licensed under chapter
  203  458 or chapter 459 who writes fewer than 50 prescriptions for a
  204  controlled substance for all of his or her patients combined in
  205  any one calendar year.
  206         Section 2. Paragraph (a) of subsection (1) of section
  207  458.3265, Florida Statutes, is amended to read:
  208         458.3265 Pain-management clinics.—
  209         (1) REGISTRATION.—
  210         (a)1. As used in this section, the term:
  211         a. “Chronic nonmalignant pain” means pain unrelated to
  212  cancer, or rheumatoid arthritis, or sickle cell anemia which
  213  persists beyond the usual course of disease or beyond the injury
  214  that is the cause of the pain or which persists more than 90
  215  days after surgery.
  216         b. “Pain-management clinic” or “clinic” means any publicly
  217  or privately owned facility:
  218         (I) That advertises in any medium for any type of pain
  219  management services; or
  220         (II) Where in any month a majority of patients are
  221  prescribed opioids, benzodiazepines, barbiturates, or
  222  carisoprodol for the treatment of chronic nonmalignant pain.
  223         2. Each pain-management clinic must register with the
  224  department unless:
  225         a. The That clinic is licensed as a facility pursuant to
  226  chapter 395;
  227         b. The majority of the physicians who provide services in
  228  the clinic primarily provide primarily surgical services;
  229         c. The clinic is owned by a publicly held corporation whose
  230  shares are traded on a national exchange or on the over-the
  231  counter market and whose total assets at the end of the
  232  corporation’s most recent fiscal quarter exceeded $50 million;
  233         d. The clinic is affiliated with an accredited medical
  234  school at which training is provided for medical students,
  235  residents, or fellows;
  236         e. The clinic does not prescribe controlled substances for
  237  the treatment of pain;
  238         f. The clinic is owned by a corporate entity exempt from
  239  federal taxation under 26 U.S.C. s. 501(c)(3);
  240         g. The clinic is wholly owned and operated by one or more
  241  board-eligible or board-certified anesthesiologists,
  242  physiatrists, psychiatrists, rheumatologists, or neurologists;
  243  or
  244         h. The clinic is wholly owned and operated by one or more
  245  board-eligible or board-certified medical specialists who have
  246  also completed fellowships in pain medicine approved by the
  247  Accreditation Council for Graduate Medical Education, or who are
  248  also board eligible or board certified board-certified in pain
  249  medicine by a board approved by the American Board of Pain
  250  Medicine or the American Board of Medical Specialties and
  251  perform interventional pain procedures of the type routinely
  252  billed using surgical codes;.
  253         i.The clinic is organized as a physician-owned group
  254  practice as defined in 42 C.F.R. s. 411.352; or
  255         j.Before June 1, 2011, the clinic was wholly owned by
  256  physicians who are not board eligible or board certified but who
  257  successfully completed a residency program in anesthesiology,
  258  psychiatry, rheumatology, or neurology and who have 7 years of
  259  documented, full-time practice in pain medicine in this state.
  260  For purposes of this paragraph, the term “full-time” is defined
  261  as practicing an average of 20 hours per week each year in pain
  262  medicine.
  263         Section 3. Paragraph (a) of subsection (1) of section
  264  459.0137, Florida Statutes, is amended to read:
  265         459.0137 Pain-management clinics.—
  266         (1) REGISTRATION.—
  267         (a)1. As used in this section, the term:
  268         a. “Chronic nonmalignant pain” means pain unrelated to
  269  cancer, or rheumatoid arthritis, or sickle cell anemia which
  270  persists beyond the usual course of disease or beyond the injury
  271  that is the cause of the pain or which persists more than 90
  272  days after surgery.
  273         b. “Pain-management clinic” or “clinic” means any publicly
  274  or privately owned facility:
  275         (I) That advertises in any medium for any type of pain
  276  management services; or
  277         (II) Where in any month a majority of patients are
  278  prescribed opioids, benzodiazepines, barbiturates, or
  279  carisoprodol for the treatment of chronic nonmalignant pain.
  280         2. Each pain-management clinic must register with the
  281  department unless:
  282         a. The That clinic is licensed as a facility pursuant to
  283  chapter 395;
  284         b. The majority of the physicians who provide services in
  285  the clinic primarily provide primarily surgical services;
  286         c. The clinic is owned by a publicly held corporation whose
  287  shares are traded on a national exchange or on the over-the
  288  counter market and whose total assets at the end of the
  289  corporation’s most recent fiscal quarter exceeded $50 million;
  290         d. The clinic is affiliated with an accredited medical
  291  school at which training is provided for medical students,
  292  residents, or fellows;
  293         e. The clinic does not prescribe controlled substances for
  294  the treatment of pain;
  295         f. The clinic is owned by a corporate entity exempt from
  296  federal taxation under 26 U.S.C. s. 501(c)(3);
  297         g. The clinic is wholly owned and operated by one or more
  298  board-eligible or board-certified anesthesiologists,
  299  physiatrists, psychiatrists, rheumatologists, or neurologists;
  300  or
  301         h. The clinic is wholly owned and operated by one or more
  302  board-eligible or board-certified medical specialists who have
  303  also completed fellowships in pain medicine approved by the
  304  Accreditation Council for Graduate Medical Education or the
  305  American Osteopathic Association, or who are also board eligible
  306  or board certified board-certified in pain medicine by a board
  307  approved by the American Board of Medical Specialties, the
  308  American Association of Physician Specialties, or the American
  309  Osteopathic Association and perform interventional pain
  310  procedures of the type routinely billed using surgical codes.
  311         Section 4. Paragraph (b) of subsection (1) of section
  312  465.0276, Florida Statutes, is amended to read:
  313         465.0276 Dispensing practitioner.—
  314         (1)
  315         (b) A practitioner registered under this section may not
  316  dispense a controlled substance listed in Schedule II or
  317  Schedule III as provided in s. 893.03. This paragraph does not
  318  apply to:
  319         1. The dispensing of complimentary packages of medicinal
  320  drugs which are labeled as a drug sample or complimentary drug
  321  as defined in s. 499.028 to the practitioner’s own patients in
  322  the regular course of her or his practice without the payment of
  323  a fee or remuneration of any kind, whether direct or indirect,
  324  as provided in subsection (5).
  325         2. The dispensing of controlled substances in the health
  326  care system of the Department of Corrections.
  327         3. The dispensing of a controlled substance listed in
  328  Schedule II or Schedule III in connection with the performance
  329  of a surgical procedure. The amount dispensed pursuant to the
  330  subparagraph may not exceed a 14-day supply. This exception does
  331  not allow for the dispensing of a controlled substance listed in
  332  Schedule II or Schedule III more than 14 days after the
  333  performance of the surgical procedure. For purposes of this
  334  subparagraph, the term “surgical procedure” means any procedure
  335  in any setting which involves, or reasonably should involve:
  336         a. Perioperative medication and sedation that allows the
  337  patient to tolerate unpleasant procedures while maintaining
  338  adequate cardiorespiratory function and the ability to respond
  339  purposefully to verbal or tactile stimulation and makes intra-
  340  and postoperative monitoring necessary; or
  341         b. The use of general anesthesia or major conduction
  342  anesthesia and preoperative sedation.
  343         4. The dispensing of a controlled substance listed in
  344  Schedule II or Schedule III pursuant to an approved clinical
  345  trial. For purposes of this subparagraph, the term “approved
  346  clinical trial” means a clinical research study or clinical
  347  investigation that, in whole or in part, is state or federally
  348  funded or is conducted under protocols approved an
  349  investigational new drug application that is reviewed by the
  350  United States Food and Drug Administration.
  351         5. The dispensing of methadone in a facility licensed under
  352  s. 397.427 where medication-assisted treatment for opiate
  353  addiction is provided.
  354         6. The dispensing of a controlled substance listed in
  355  Schedule II or Schedule III to a patient of a facility licensed
  356  under part IV of chapter 400.
  357         Section 5. Paragraph (b) of subsection (5) and paragraph
  358  (b) of subsection (7) of section 893.055, Florida Statutes, are
  359  amended to read:
  360         893.055 Prescription drug monitoring program.—
  361         (5) When the following acts of dispensing or administering
  362  occur, the following are exempt from reporting under this
  363  section for that specific act of dispensing or administration:
  364         (b) A pharmacist or health care practitioner when
  365  administering a controlled substance to a patient who is
  366  receiving hospice care or to a patient or resident receiving
  367  care as a patient at a hospital, nursing home, ambulatory
  368  surgical center, hospice, or intermediate care facility for the
  369  developmentally disabled which is licensed in this state.
  370         (7)
  371         (b) A pharmacy, prescriber, or dispenser shall have access
  372  to information in the prescription drug monitoring program’s
  373  database which relates to a patient, or a potential patient, of
  374  that pharmacy, prescriber, or dispenser in a manner established
  375  by the department as needed for the purpose of reviewing the
  376  patient’s controlled substance prescription history. Other
  377  access to the program’s database shall be limited to the
  378  program’s manager and to the designated program and support
  379  staff, who may act only at the direction of the program manager
  380  or, in the absence of the program manager, as authorized. Access
  381  by the program manager or such designated staff is for
  382  prescription drug program management only or for management of
  383  the program’s database and its system in support of the
  384  requirements of this section and in furtherance of the
  385  prescription drug monitoring program. Confidential and exempt
  386  information in the database shall be released only as provided
  387  in paragraph (c) and s. 893.0551. The program manager,
  388  designated program and support staff who act at the direction of
  389  or in the absence of the program manager, and any individual who
  390  has similar access regarding the management of the database from
  391  the prescription drug monitoring program shall submit
  392  fingerprints to the department for background screening. The
  393  department shall follow the procedure established by the
  394  Department of Law Enforcement to request a statewide criminal
  395  history record check and to request that the Department of Law
  396  Enforcement forward the fingerprints to the Federal Bureau of
  397  Investigation for a national criminal history record check.
  398  
  399  ================= T I T L E  A M E N D M E N T ================
  400         And the title is amended as follows:
  401         Delete line 2
  402  and insert:
  403         An act relating to controlled substances; amending s.
  404         456.44, F.S.; revising the definition of the term
  405         “addiction medicine specialist” to include a board
  406         certified psychiatrist, rather than a physiatrist;
  407         redefining the term “board-certified pain management
  408         physician” to include a physician who possesses board
  409         certification or subcertification in pain management
  410         by a specialty board recognized by the American Board
  411         of Medical Specialties; redefining the term “chronic
  412         nonmalignant pain”; providing requirements that a
  413         physician who prescribes certain specific controlled
  414         substances for the treatment of chronic nonmalignant
  415         pain must fulfill; providing that the management of
  416         pain in certain patients requires consultation with or
  417         referral to a psychiatrist, rather than a physiatrist;
  418         providing that a prescription is deemed compliant with
  419         the standards of practice and is valid for dispensing
  420         when a pharmacy receives it; providing that the
  421         standards of practice regarding the prescribing of
  422         controlled substances do not apply to certain
  423         physicians; amending s. 458.3265, F.S.; revising the
  424         definition of the term “chronic nonmalignant pain”;
  425         requiring that a pain-management clinic register with
  426         the Department of Health unless the clinic is wholly
  427         owned by certain board-eligible or board-certified
  428         physicians or medical specialists, organized as a
  429         physician-owned group practice, or wholly owned by
  430         physicians who are not board eligible or board
  431         certified but who have completed specified residency
  432         programs and have a specified number of years of full
  433         time practice in pain medicine; amending s. 459.0137,
  434         F.S.; revising the definition of “chronic nonmalginant
  435         pain”; requiring that a pain-management clinic
  436         register with the Department of Health unless the
  437         clinic is wholly owned by certain health care
  438         practitioners; amending s. 465.0276, F.S.; redefining
  439         the term “approved clinical trial” as it relates to
  440         the Florida Pharmacy Act; amending s. 893.055, F.S.;
  441         providing that a pharmacist or health care
  442         practitioner is exempt from reporting a dispensed
  443         controlled substance to the Department of Health when
  444         administering the controlled substance to a patient
  445         who is receiving hospice care or to a patient or
  446         resident receiving care at certain medical facilities
  447         licensed in the state; requiring that a pharmacy,
  448         prescriber, or dispenser have access to information in
  449         the prescription drug monitoring program’s database
  450         which relates to a patient, or a potential patient, of
  451         that pharmacy, prescriber, or dispenser for the
  452         purpose of reviewing the patient’s controlled
  453         substance prescription history; amending s.