Florida Senate - 2012                          SENATOR AMENDMENT
       Bill No. CS/CS/HB 1175, 1st Eng.
       
       
       
       
       
       
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                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/R/3R          .        Floor: SENA1/RC         
             03/09/2012 06:56 PM       .      03/07/2012 05:41 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) “Board eligible” means the successful completion of an
   31  anesthesia, physical medicine and rehabilitation, rheumatology,
   32  or neurology residency program that is approved by the
   33  Accreditation Council for Graduate Medical Education or the
   34  American Osteopathic Association. The residency program must
   35  have been successfully completed within the previous 6 years in
   36  order for the individual to remain board eligible in the
   37  designated specialty.
   38         (e)(d) “Chronic nonmalignant pain” means pain unrelated to
   39  cancer, or rheumatoid arthritis, or sickle cell anemia which
   40  persists beyond the usual course of disease or beyond the injury
   41  that is the cause of the pain or which persists more than 90
   42  days after surgery.
   43         (f)(e) “Mental health addiction facility” means a facility
   44  licensed under chapter 394 or chapter 397.
   45         (2) REGISTRATION.—Effective January 1, 2012, a physician
   46  licensed under chapter 458, chapter 459, chapter 461, or chapter
   47  466 who prescribes more than a 30-day supply of any controlled
   48  substance listed in Schedule II, Schedule III, or Schedule IV,
   49  as defined in s. 893.03, over a 6-month period to any one
   50  patient for the treatment of chronic nonmalignant pain, must:
   51         (a) Designate himself or herself as a controlled substance
   52  prescribing practitioner on the physician’s practitioner
   53  profile.
   54         (b) Comply with the requirements of this section and
   55  applicable board rules.
   56         (3) STANDARDS OF PRACTICE.—The standards of practice in
   57  this section do not supersede the level of care, skill, and
   58  treatment recognized in general law related to health care
   59  licensure.
   60         (a) A complete medical history and a physical examination
   61  must be conducted before beginning any treatment and must be
   62  documented in the medical record. The exact components of the
   63  physical examination shall be left to the judgment of the
   64  clinician who is expected to perform a physical examination
   65  proportionate to the diagnosis that justifies a treatment. The
   66  medical record must, at a minimum, document the nature and
   67  intensity of the pain, current and past treatments for pain,
   68  underlying or coexisting diseases or conditions, the effect of
   69  the pain on physical and psychological function, a review of
   70  previous medical records, previous diagnostic studies, and
   71  history of alcohol and substance abuse. The medical record must
   72  shall also document the presence of one or more recognized
   73  medical indications for the use of a controlled substance. Each
   74  registrant must develop a written plan for assessing each
   75  patient’s risk of aberrant drug-related behavior, which may
   76  include patient drug testing. Registrants must assess each
   77  patient’s risk for aberrant drug-related behavior and monitor
   78  that risk on an ongoing basis in accordance with the plan.
   79         (b) Each registrant must develop a written individualized
   80  treatment plan for each patient. The treatment plan must shall
   81  state objectives that will be used to determine treatment
   82  success, such as pain relief and improved physical and
   83  psychosocial function, and must shall indicate if any further
   84  diagnostic evaluations or other treatments are planned. After
   85  treatment begins, the physician shall adjust drug therapy to the
   86  individual medical needs of each patient. Other treatment
   87  modalities, including a rehabilitation program, shall be
   88  considered depending on the etiology of the pain and the extent
   89  to which the pain is associated with physical and psychosocial
   90  impairment. The interdisciplinary nature of the treatment plan
   91  shall be documented.
   92         (c) The physician shall discuss the risks and benefits of
   93  the use of controlled substances, including the risks of abuse
   94  and addiction, as well as physical dependence and its
   95  consequences, with the patient, persons designated by the
   96  patient, or the patient’s surrogate or guardian if the patient
   97  is incompetent. The physician shall use a written controlled
   98  substance agreement between the physician and the patient
   99  outlining the patient’s responsibilities, including, but not
  100  limited to:
  101         1. Number and frequency of prescriptions and refills for
  102  controlled substances substance prescriptions and refills.
  103         2. Patient compliance and reasons for which drug therapy
  104  may be discontinued, such as a violation of the agreement.
  105         3. An agreement that controlled substances for the
  106  treatment of chronic nonmalignant pain shall be prescribed by a
  107  single treating physician unless otherwise authorized by the
  108  treating physician and documented in the medical record.
  109         (d) The patient shall be seen by the physician at regular
  110  intervals, not to exceed 3 months, to assess the efficacy of
  111  treatment, ensure that controlled-substance controlled substance
  112  therapy remains indicated, evaluate the patient’s progress
  113  toward treatment objectives, consider adverse drug effects, and
  114  review the etiology of the pain. Continuation or modification of
  115  therapy depends shall depend on the physician’s evaluation of
  116  the patient’s progress. If treatment goals are not being
  117  achieved, despite medication adjustments, the physician shall
  118  reevaluate the appropriateness of continued treatment. The
  119  physician shall monitor patient compliance in medication usage,
  120  related treatment plans, controlled substance agreements, and
  121  indications of substance abuse or diversion at a minimum of 3
  122  month intervals.
  123         (e) The physician shall refer the patient as necessary for
  124  additional evaluation and treatment in order to achieve
  125  treatment objectives. Special attention shall be given to those
  126  patients who are at risk for misusing their medications and
  127  those whose living arrangements pose a risk for medication
  128  misuse or diversion. The management of pain in patients with a
  129  history of substance abuse or with a comorbid psychiatric
  130  disorder requires extra care, monitoring, and documentation and
  131  requires consultation with or referral to an addiction medicine
  132  specialist addictionologist or psychiatrist physiatrist.
  133         (f) A physician registered under this section must maintain
  134  accurate, current, and complete records that are accessible and
  135  readily available for review and comply with the requirements of
  136  this section, the applicable practice act, and applicable board
  137  rules. The medical records must include, but are not limited to:
  138         1. The complete medical history and a physical examination,
  139  including history of drug abuse or dependence.
  140         2. Diagnostic, therapeutic, and laboratory results.
  141         3. Evaluations and consultations.
  142         4. Treatment objectives.
  143         5. Discussion of risks and benefits.
  144         6. Treatments.
  145         7. Medications, including date, type, dosage, and quantity
  146  prescribed.
  147         8. Instructions and agreements.
  148         9. Periodic reviews.
  149         10. Results of any drug testing.
  150         11. A photocopy of the patient’s government-issued photo
  151  identification.
  152         12. If a written prescription for a controlled substance is
  153  given to the patient, a duplicate of the prescription.
  154         13. The physician’s full name presented in a legible
  155  manner.
  156         (g) Patients with signs or symptoms of substance abuse
  157  shall be immediately referred to a board-certified pain
  158  management physician, an addiction medicine specialist, or a
  159  mental health addiction facility as it pertains to drug abuse or
  160  addiction unless the physician is board eligible or board
  161  certified board-certified or board-eligible in pain management.
  162  Throughout the period of time before receiving the consultant’s
  163  report, a prescribing physician shall clearly and completely
  164  document medical justification for continued treatment with
  165  controlled substances and those steps taken to ensure medically
  166  appropriate use of controlled substances by the patient. Upon
  167  receipt of the consultant’s written report, the prescribing
  168  physician shall incorporate the consultant’s recommendations for
  169  continuing, modifying, or discontinuing the controlled-substance
  170  controlled substance therapy. The resulting changes in treatment
  171  shall be specifically documented in the patient’s medical
  172  record. Evidence or behavioral indications of diversion shall be
  173  followed by discontinuation of the controlled-substance
  174  controlled substance therapy, and the patient shall be
  175  discharged, and all results of testing and actions taken by the
  176  physician shall be documented in the patient’s medical record.
  177         (h) When a pharmacy receives a prescription issued by a
  178  physician pursuant to this section, the dispensing of such
  179  prescription is deemed compliant with the standards of practice
  180  under this section and, therefore, valid for dispensing.
  181  
  182  This subsection does not apply to a board-eligible or board
  183  certified anesthesiologist, physiatrist, psychiatrist,
  184  rheumatologist, or neurologist, or to a board-certified
  185  physician who has surgical privileges at a hospital or
  186  ambulatory surgery center and primarily provides surgical
  187  services. This subsection does not apply to a board-eligible or
  188  board-certified medical specialist who has also completed a
  189  fellowship in pain medicine approved by the Accreditation
  190  Council for Graduate Medical Education or the American
  191  Osteopathic Association, or who is board eligible or board
  192  certified in pain medicine by a board approved by the American
  193  Board of Pain Medicine, the American Board of Medical
  194  Specialties, or the American Osteopathic Association and
  195  performs interventional pain procedures of the type routinely
  196  billed using surgical codes. This subsection does not apply to a
  197  physician certified by the American Board of Medical Specialties
  198  in hospice and palliative medicine or to an osteopathic
  199  physician who holds a certificate of added qualification in
  200  hospice and palliative medicine through the American Osteopathic
  201  Association. This subsection does not apply to a physician who
  202  prescribes medically necessary controlled substances for a
  203  patient during an inpatient stay or while providing emergency
  204  services and care in a hospital licensed under chapter 395. This
  205  subsection does not apply to a physician who treats a patient
  206  who is admitted in a nursing home or related health care
  207  facility or receiving hospice services as defined in chapter
  208  400. This subsection does not apply to a physician who treats a
  209  patient in accordance with an approved clinical trial. This
  210  subsection does not apply to a physician licensed under chapter
  211  458 or chapter 459 who writes fewer than 50 prescriptions for a
  212  controlled substance for all of his or her patients combined in
  213  any one calendar year.
  214         Section 2. Paragraph (a) of subsection (1) of section
  215  458.3265, Florida Statutes, is amended to read:
  216         458.3265 Pain-management clinics.—
  217         (1) REGISTRATION.—
  218         (a)1. As used in this section, the term:
  219         a. “Chronic nonmalignant pain” means pain unrelated to
  220  cancer, or rheumatoid arthritis, or sickle cell anemia which
  221  persists beyond the usual course of disease or beyond the injury
  222  that is the cause of the pain or which persists more than 90
  223  days after surgery.
  224         b. “Pain-management clinic” or “clinic” means any publicly
  225  or privately owned facility:
  226         (I) That advertises in any medium for any type of pain
  227  management services; or
  228         (II) Where in any month a majority of patients are
  229  prescribed opioids, benzodiazepines, barbiturates, or
  230  carisoprodol for the treatment of chronic nonmalignant pain.
  231         2. Each pain-management clinic must register with the
  232  department unless:
  233         a. The That clinic is licensed as a facility pursuant to
  234  chapter 395;
  235         b. The majority of the physicians who provide services in
  236  the clinic primarily provide primarily surgical services;
  237         c. The clinic is owned by a publicly held corporation whose
  238  shares are traded on a national exchange or on the over-the
  239  counter market and whose total assets at the end of the
  240  corporation’s most recent fiscal quarter exceeded $50 million;
  241         d. The clinic is affiliated with an accredited medical
  242  school at which training is provided for medical students,
  243  residents, or fellows;
  244         e. The clinic does not prescribe controlled substances for
  245  the treatment of pain;
  246         f. The clinic is owned by a corporate entity exempt from
  247  federal taxation under 26 U.S.C. s. 501(c)(3);
  248         g. The clinic is wholly owned and operated by one or more
  249  board-eligible or board-certified anesthesiologists,
  250  physiatrists, psychiatrists, rheumatologists, or neurologists;
  251  or
  252         h. The clinic is wholly owned and operated by one or more
  253  board-eligible or board-certified medical specialists who have
  254  also completed fellowships in pain medicine approved by the
  255  Accreditation Council for Graduate Medical Education, or who are
  256  also board eligible or board certified board-certified in pain
  257  medicine by a board approved by the American Board of Pain
  258  Medicine or the American Board of Medical Specialties and
  259  perform interventional pain procedures of the type routinely
  260  billed using surgical codes;. or
  261         i. The clinic is organized as a physician-owned group
  262  practice as defined in 42 C.F.R. s. 411.352.
  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 nonmalignant
  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.