Florida Senate - 2012                             CS for SB 1198
       
       
       
       By the Committee on Health Regulation; and Senator Bogdanoff
       
       
       
       
       588-02713A-12                                         20121198c1
    1                        A bill to be entitled                      
    2         An act relating to the prescribing of controlled
    3         substances; amending s. 456.44, F.S.; revising the
    4         definition of the term “addiction medicine specialist”
    5         to include a board-certified psychiatrist, rather than
    6         a physiatrist; redefining the term “board-certified
    7         pain management physician” to include a physician who
    8         possesses board certification or subcertification in
    9         pain management by a specialty board recognized by the
   10         American Board of Medical Specialties; redefining the
   11         term “chronic nonmalignant pain”; providing
   12         requirements that a physician who prescribes certain
   13         specific controlled substances for the treatment of
   14         chronic nonmalignant pain must fulfill; providing that
   15         the management of pain in certain patients requires
   16         consultation with or referral to a psychiatrist,
   17         rather than a physiatrist; providing that a
   18         prescription is deemed compliant with the standards of
   19         practice and is valid for dispensing when a pharmacy
   20         receives it; providing that the standards of practice
   21         regarding the prescribing of controlled substances do
   22         not apply to certain physicians; amending s. 458.3265,
   23         F.S.; revising the definition of the term “chronic
   24         nonmalignant pain”; requiring that a pain-management
   25         clinic register with the Department of Health unless
   26         the clinic is wholly owned by certain board-eligible
   27         or board-certified physicians or medical specialists,
   28         organized as a physician-owned group practice, or
   29         wholly owned by physicians who are not board eligible
   30         or board certified but who have completed specified
   31         residency programs and have a specified number of
   32         years of full-time practice in pain medicine; amending
   33         s. 459.0137, F.S.; revising the definition of “chronic
   34         nonmalginant pain”; requiring that a pain-management
   35         clinic register with the Department of Health unless
   36         the clinic is wholly owned by certain health care
   37         practitioners; amending s. 465.0276, F.S.; redefining
   38         the term “approved clinical trial” as it relates to
   39         the Florida Pharmacy Act; amending s. 893.055, F.S.;
   40         providing that a pharmacist or health care
   41         practitioner is exempt from reporting a dispensed
   42         controlled substance to the Department of Health when
   43         administering the controlled substance to a patient
   44         who is receiving hospice care or to a patient or
   45         resident receiving care at certain medical facilities
   46         licensed in the state; requiring that a pharmacy,
   47         prescriber, or dispenser have access to information in
   48         the prescription drug monitoring program’s database
   49         which relates to a patient, or a potential patient, of
   50         that pharmacy, prescriber, or dispenser for the
   51         purpose of reviewing the patient’s controlled
   52         substance prescription history; providing an effective
   53         date.
   54  
   55  Be It Enacted by the Legislature of the State of Florida:
   56  
   57         Section 1. Section 456.44, Florida Statutes, is amended to
   58  read:
   59         456.44 Controlled substance prescribing.—
   60         (1) DEFINITIONS.—
   61         (a) “Addiction medicine specialist” means a board-certified
   62  psychiatrist who holds physiatrist with a subspecialty
   63  certification in addiction medicine or who is eligible for such
   64  subspecialty certification in addiction medicine, a an addiction
   65  medicine physician who is certified or eligible for
   66  certification by the American Society of Addiction Medicine, or
   67  an osteopathic physician who holds a certificate of added
   68  qualification in Addiction Medicine through the American
   69  Osteopathic Association.
   70         (b) “Adverse incident” means any incident set forth in s.
   71  458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
   72         (c) “Board–certified pain management physician” means a
   73  physician who possesses board certification in pain medicine by
   74  the American Board of Pain Medicine, board certification by the
   75  American Board of Interventional Pain Physicians, or board
   76  certification or subcertification in pain management by a
   77  specialty board recognized by the American Association of
   78  Physician Specialists or the American Board of Medical
   79  Specialties or an osteopathic physician who holds a certificate
   80  in Pain Management by the American Osteopathic Association.
   81         (d) “Chronic nonmalignant pain” means pain unrelated to
   82  cancer, or rheumatoid arthritis, or sickle cell anemia which
   83  persists beyond the usual course of disease or beyond the injury
   84  that is the cause of the pain or which persists more than 90
   85  days after surgery.
   86         (e) “Mental health addiction facility” means a facility
   87  licensed under chapter 394 or chapter 397.
   88         (2) REGISTRATION.—Effective January 1, 2012, a physician
   89  licensed under chapter 458, chapter 459, chapter 461, or chapter
   90  466 who prescribes any controlled substance listed in Schedule
   91  II, Schedule III, or Schedule IV of as defined in s. 893.03, for
   92  the treatment of chronic nonmalignant pain, must:
   93         (a) Designate himself or herself as a controlled substance
   94  prescribing practitioner on the physician’s practitioner
   95  profile.
   96         (b) Comply with the requirements of this section and
   97  applicable board rules.
   98         (3) STANDARDS OF PRACTICE.—The standards of practice in
   99  this section do not supersede the level of care, skill, and
  100  treatment recognized in general law related to health care
  101  licensure.
  102         (a) A complete medical history and a physical examination
  103  must be conducted before beginning any treatment and must be
  104  documented in the medical record. The exact components of the
  105  physical examination shall be left to the judgment of the
  106  clinician who is expected to perform a physical examination
  107  proportionate to the diagnosis that justifies a treatment. The
  108  medical record must, at a minimum, document the nature and
  109  intensity of the pain, current and past treatments for pain,
  110  underlying or coexisting diseases or conditions, the effect of
  111  the pain on physical and psychological function, a review of
  112  previous medical records, previous diagnostic studies, and
  113  history of alcohol and substance abuse. The medical record must
  114  shall also document the presence of one or more recognized
  115  medical indications for the use of a controlled substance. Each
  116  registrant must develop a written plan for assessing each
  117  patient’s risk of aberrant drug-related behavior, which may
  118  include patient drug testing. Registrants must assess each
  119  patient’s risk for aberrant drug-related behavior and monitor
  120  that risk on an ongoing basis in accordance with the plan.
  121         (b) Each registrant must develop a written individualized
  122  treatment plan for each patient. The treatment plan must shall
  123  state objectives that will be used to determine treatment
  124  success, such as pain relief and improved physical and
  125  psychosocial function, and must shall indicate if any further
  126  diagnostic evaluations or other treatments are planned. After
  127  treatment begins, the physician shall adjust drug therapy to the
  128  individual medical needs of each patient. Other treatment
  129  modalities, including a rehabilitation program, shall be
  130  considered depending on the etiology of the pain and the extent
  131  to which the pain is associated with physical and psychosocial
  132  impairment. The interdisciplinary nature of the treatment plan
  133  shall be documented.
  134         (c) The physician shall discuss the risks and benefits of
  135  the use of controlled substances, including the risks of abuse
  136  and addiction, as well as physical dependence and its
  137  consequences, with the patient, persons designated by the
  138  patient, or the patient’s surrogate or guardian if the patient
  139  is incompetent. The physician shall use a written controlled
  140  substance agreement between the physician and the patient
  141  outlining the patient’s responsibilities, including, but not
  142  limited to:
  143         1. Number and frequency of prescriptions and refills for
  144  controlled substances substance prescriptions and refills.
  145         2. Patient compliance and reasons for which drug therapy
  146  may be discontinued, such as a violation of the agreement.
  147         3. An agreement that controlled substances for the
  148  treatment of chronic nonmalignant pain shall be prescribed by a
  149  single treating physician unless otherwise authorized by the
  150  treating physician and documented in the medical record.
  151         (d) The patient shall be seen by the physician at regular
  152  intervals, not to exceed 3 months, to assess the efficacy of
  153  treatment, ensure that controlled-substance controlled substance
  154  therapy remains indicated, evaluate the patient’s progress
  155  toward treatment objectives, consider adverse drug effects, and
  156  review the etiology of the pain. Continuation or modification of
  157  therapy depends shall depend on the physician’s evaluation of
  158  the patient’s progress. If treatment goals are not being
  159  achieved, despite medication adjustments, the physician shall
  160  reevaluate the appropriateness of continued treatment. The
  161  physician shall monitor patient compliance in medication usage,
  162  related treatment plans, controlled substance agreements, and
  163  indications of substance abuse or diversion at a minimum of 3
  164  month intervals.
  165         (e) The physician shall refer the patient as necessary for
  166  additional evaluation and treatment in order to achieve
  167  treatment objectives. Special attention shall be given to those
  168  patients who are at risk for misusing their medications and
  169  those whose living arrangements pose a risk for medication
  170  misuse or diversion. The management of pain in patients with a
  171  history of substance abuse or with a comorbid psychiatric
  172  disorder requires extra care, monitoring, and documentation and
  173  requires consultation with or referral to an addictionologist or
  174  psychiatrist physiatrist.
  175         (f) A physician registered under this section must maintain
  176  accurate, current, and complete records that are accessible and
  177  readily available for review and comply with the requirements of
  178  this section, the applicable practice act, and applicable board
  179  rules. The medical records must include, but are not limited to:
  180         1. The complete medical history and a physical examination,
  181  including history of drug abuse or dependence.
  182         2. Diagnostic, therapeutic, and laboratory results.
  183         3. Evaluations and consultations.
  184         4. Treatment objectives.
  185         5. Discussion of risks and benefits.
  186         6. Treatments.
  187         7. Medications, including date, type, dosage, and quantity
  188  prescribed.
  189         8. Instructions and agreements.
  190         9. Periodic reviews.
  191         10. Results of any drug testing.
  192         11. A photocopy of the patient’s government-issued photo
  193  identification.
  194         12. If a written prescription for a controlled substance is
  195  given to the patient, a duplicate of the prescription.
  196         13. The physician’s full name presented in a legible
  197  manner.
  198         (g) Patients with signs or symptoms of substance abuse
  199  shall be immediately referred to a board-certified pain
  200  management physician, an addiction medicine specialist, or a
  201  mental health addiction facility as it pertains to drug abuse or
  202  addiction unless the physician is board-certified or board
  203  eligible in pain management. Throughout the period of time
  204  before receiving the consultant’s report, a prescribing
  205  physician shall clearly and completely document medical
  206  justification for continued treatment with controlled substances
  207  and those steps taken to ensure medically appropriate use of
  208  controlled substances by the patient. Upon receipt of the
  209  consultant’s written report, the prescribing physician shall
  210  incorporate the consultant’s recommendations for continuing,
  211  modifying, or discontinuing the controlled-substance controlled
  212  substance therapy. The resulting changes in treatment shall be
  213  specifically documented in the patient’s medical record.
  214  Evidence or behavioral indications of diversion shall be
  215  followed by discontinuation of the controlled-substance
  216  controlled substance therapy, and the patient shall be
  217  discharged, and all results of testing and actions taken by the
  218  physician shall be documented in the patient’s medical record.
  219         (h) When a pharmacy subject to this section receives a
  220  prescription, the prescription is deemed compliant with the
  221  standards of practice under this section and, therefore, valid
  222  for dispensing.
  223  
  224  This subsection does not apply to a board-eligible or board
  225  certified anesthesiologist, physiatrist, psychiatrist,
  226  rheumatologist, or neurologist, or to a board-certified
  227  physician who has surgical privileges at a hospital or
  228  ambulatory surgery center and primarily provides surgical
  229  services. This subsection does not apply to a board-eligible or
  230  board-certified medical specialist who has also completed a
  231  fellowship in pain medicine approved by the Accreditation
  232  Council for Graduate Medical Education or the American
  233  Osteopathic Association, or who is board-eligible or board
  234  certified in pain medicine by a board approved by the American
  235  Board of Pain Medicine, the American Board of Medical
  236  Specialties, or the American Osteopathic Association and
  237  performs interventional pain procedures of the type routinely
  238  billed using surgical codes. This subsection does not apply to a
  239  physician certified by the American Board of Medical Specialties
  240  in hospice and palliative medicine or to an osteopathic
  241  physician who holds a certificate of added qualification in
  242  hospice and palliative medicine through the American Osteopathic
  243  Association. This subsection does not apply to hospitalists or
  244  other physicians who prescribe medically necessary controlled
  245  substances for a patient during an inpatient stay or while
  246  providing emergency services and care in a hospital licensed
  247  under chapter 395. This subsection does not apply to a physician
  248  who is treating a patient in accordance with an approved
  249  clinical trial.
  250         Section 2. Paragraph (a) of subsection (1) of section
  251  458.3265, Florida Statutes, is amended to read:
  252         458.3265 Pain-management clinics.—
  253         (1) REGISTRATION.—
  254         (a)1. As used in this section, the term:
  255         a. “Chronic nonmalignant pain” means pain unrelated to
  256  cancer, or rheumatoid arthritis, or sickle cell anemia which
  257  persists beyond the usual course of disease or beyond the injury
  258  that is the cause of the pain or which persists more than 90
  259  days after surgery.
  260         b. “Pain-management clinic” or “clinic” means any publicly
  261  or privately owned facility:
  262         (I) That advertises in any medium for any type of pain
  263  management services; or
  264         (II) Where in any month a majority of patients are
  265  prescribed opioids, benzodiazepines, barbiturates, or
  266  carisoprodol for the treatment of chronic nonmalignant pain.
  267         2. Each pain-management clinic must register with the
  268  department unless:
  269         a. The That clinic is licensed as a facility pursuant to
  270  chapter 395;
  271         b. The majority of the physicians who provide services in
  272  the clinic primarily provide primarily surgical services;
  273         c. The clinic is owned by a publicly held corporation whose
  274  shares are traded on a national exchange or on the over-the
  275  counter market and whose total assets at the end of the
  276  corporation’s most recent fiscal quarter exceeded $50 million;
  277         d. The clinic is affiliated with an accredited medical
  278  school at which training is provided for medical students,
  279  residents, or fellows;
  280         e. The clinic does not prescribe controlled substances for
  281  the treatment of pain;
  282         f. The clinic is owned by a corporate entity exempt from
  283  federal taxation under 26 U.S.C. s. 501(c)(3);
  284         g. The clinic is wholly owned and operated by one or more
  285  board-eligible or board-certified anesthesiologists,
  286  physiatrists, psychiatrists, rheumatologists, or neurologists;
  287  or
  288         h. The clinic is wholly owned and operated by one or more
  289  board-eligible or board-certified medical specialists who have
  290  also completed fellowships in pain medicine approved by the
  291  Accreditation Council for Graduate Medical Education, or who are
  292  also board-eligible or board-certified in pain medicine by a
  293  board approved by the American Board of Pain Medicine or the
  294  American Board of Medical Specialties and perform interventional
  295  pain procedures of the type routinely billed using surgical
  296  codes;.
  297         i.The clinic is organized as a physician-owned group
  298  practice as defined in 42 C.F.R. 411,352; or
  299         j.Before June 1, 2011, the clinic was wholly owned by
  300  physicians who are not board eligible or board certified but who
  301  successfully completed a residency program in anesthesiology,
  302  physiatry, psychiatry, rheumatology, or neurology and who have 7
  303  years of documented, full-time practice in pain medicine in this
  304  state. For purposes of this paragraph, the term “full-time” is
  305  defined as practicing an average of 20 hours per week each year
  306  in pain medicine.
  307         Section 3. Paragraph (a) of subsection (1) of section
  308  459.0137, Florida Statutes, is amended to read:
  309         459.0137 Pain-management clinics.—
  310         (1) REGISTRATION.—
  311         (a)1. As used in this section, the term:
  312         a. “Chronic nonmalignant pain” means pain unrelated to
  313  cancer, or rheumatoid arthritis, or sickle cell anemia which
  314  persists beyond the usual course of disease or beyond the injury
  315  that is the cause of the pain or which persists more than 90
  316  days after surgery.
  317         b. “Pain-management clinic” or “clinic” means any publicly
  318  or privately owned facility:
  319         (I) That advertises in any medium for any type of pain
  320  management services; or
  321         (II) Where in any month a majority of patients are
  322  prescribed opioids, benzodiazepines, barbiturates, or
  323  carisoprodol for the treatment of chronic nonmalignant pain.
  324         2. Each pain-management clinic must register with the
  325  department unless:
  326         a. The That clinic is licensed as a facility pursuant to
  327  chapter 395;
  328         b. The majority of the physicians who provide services in
  329  the clinic primarily provide primarily surgical services;
  330         c. The clinic is owned by a publicly held corporation whose
  331  shares are traded on a national exchange or on the over-the
  332  counter market and whose total assets at the end of the
  333  corporation’s most recent fiscal quarter exceeded $50 million;
  334         d. The clinic is affiliated with an accredited medical
  335  school at which training is provided for medical students,
  336  residents, or fellows;
  337         e. The clinic does not prescribe controlled substances for
  338  the treatment of pain;
  339         f. The clinic is owned by a corporate entity exempt from
  340  federal taxation under 26 U.S.C. s. 501(c)(3);
  341         g. The clinic is wholly owned and operated by one or more
  342  board-eligible or board-certified anesthesiologists,
  343  physiatrists, psychiatrists, rheumatologists, or neurologists;
  344  or
  345         h. The clinic is wholly owned and operated by one or more
  346  board-eligible or board-certified medical specialists who have
  347  also completed fellowships in pain medicine approved by the
  348  Accreditation Council for Graduate Medical Education or the
  349  American Osteopathic Association, or who are also board-eligible
  350  or board-certified in pain medicine by a board approved by the
  351  American Board of Medical Specialties, the American Association
  352  of Physician Specialties, or the American Osteopathic
  353  Association and perform interventional pain procedures of the
  354  type routinely billed using surgical codes.
  355         Section 4. Paragraph (b) of subsection (1) of section
  356  465.0276, Florida Statutes, is amended to read:
  357         465.0276 Dispensing practitioner.—
  358         (1)
  359         (b) A practitioner registered under this section may not
  360  dispense a controlled substance listed in Schedule II or
  361  Schedule III as provided in s. 893.03. This paragraph does not
  362  apply to:
  363         1. The dispensing of complimentary packages of medicinal
  364  drugs which are labeled as a drug sample or complimentary drug
  365  as defined in s. 499.028 to the practitioner’s own patients in
  366  the regular course of her or his practice without the payment of
  367  a fee or remuneration of any kind, whether direct or indirect,
  368  as provided in subsection (5).
  369         2. The dispensing of controlled substances in the health
  370  care system of the Department of Corrections.
  371         3. The dispensing of a controlled substance listed in
  372  Schedule II or Schedule III in connection with the performance
  373  of a surgical procedure. The amount dispensed pursuant to the
  374  subparagraph may not exceed a 14-day supply. This exception does
  375  not allow for the dispensing of a controlled substance listed in
  376  Schedule II or Schedule III more than 14 days after the
  377  performance of the surgical procedure. For purposes of this
  378  subparagraph, the term “surgical procedure” means any procedure
  379  in any setting which involves, or reasonably should involve:
  380         a. Perioperative medication and sedation that allows the
  381  patient to tolerate unpleasant procedures while maintaining
  382  adequate cardiorespiratory function and the ability to respond
  383  purposefully to verbal or tactile stimulation and makes intra-
  384  and postoperative monitoring necessary; or
  385         b. The use of general anesthesia or major conduction
  386  anesthesia and preoperative sedation.
  387         4. The dispensing of a controlled substance listed in
  388  Schedule II or Schedule III pursuant to an approved clinical
  389  trial. For purposes of this subparagraph, the term “approved
  390  clinical trial” means a clinical research study or clinical
  391  investigation that, in whole or in part, is state or federally
  392  funded or is conducted under protocols approved an
  393  investigational new drug application that is reviewed by the
  394  United States Food and Drug Administration.
  395         5. The dispensing of methadone in a facility licensed under
  396  s. 397.427 where medication-assisted treatment for opiate
  397  addiction is provided.
  398         6. The dispensing of a controlled substance listed in
  399  Schedule II or Schedule III to a patient of a facility licensed
  400  under part IV of chapter 400.
  401         Section 5. Paragraph (b) of subsection (5) and paragraph
  402  (b) of subsection (7) of section 893.055, Florida Statutes, are
  403  amended to read:
  404         893.055 Prescription drug monitoring program.—
  405         (5) When the following acts of dispensing or administering
  406  occur, the following are exempt from reporting under this
  407  section for that specific act of dispensing or administration:
  408         (b) A pharmacist or health care practitioner when
  409  administering a controlled substance to a patient who is
  410  receiving hospice care or to a patient or resident receiving
  411  care as a patient at a hospital, nursing home, ambulatory
  412  surgical center, hospice, or intermediate care facility for the
  413  developmentally disabled which is licensed in this state.
  414         (7)
  415         (b) A pharmacy, prescriber, or dispenser shall have access
  416  to information in the prescription drug monitoring program’s
  417  database which relates to a patient, or a potential patient, of
  418  that pharmacy, prescriber, or dispenser in a manner established
  419  by the department as needed for the purpose of reviewing the
  420  patient’s controlled substance prescription history. Other
  421  access to the program’s database shall be limited to the
  422  program’s manager and to the designated program and support
  423  staff, who may act only at the direction of the program manager
  424  or, in the absence of the program manager, as authorized. Access
  425  by the program manager or such designated staff is for
  426  prescription drug program management only or for management of
  427  the program’s database and its system in support of the
  428  requirements of this section and in furtherance of the
  429  prescription drug monitoring program. Confidential and exempt
  430  information in the database shall be released only as provided
  431  in paragraph (c) and s. 893.0551. The program manager,
  432  designated program and support staff who act at the direction of
  433  or in the absence of the program manager, and any individual who
  434  has similar access regarding the management of the database from
  435  the prescription drug monitoring program shall submit
  436  fingerprints to the department for background screening. The
  437  department shall follow the procedure established by the
  438  Department of Law Enforcement to request a statewide criminal
  439  history record check and to request that the Department of Law
  440  Enforcement forward the fingerprints to the Federal Bureau of
  441  Investigation for a national criminal history record check.
  442         Section 6. This act shall take effect July 1, 2012.