Florida Senate - 2015                          SENATOR AMENDMENT
       Bill No. HB 441
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
               Floor: 1a/WD/2R         .                                
             04/23/2015 10:49 AM       .                                

       Senator Bradley moved the following:
    1         Senate Amendment to Amendment (960070) (with title
    2  amendment)
    4         Delete lines 5 - 72
    5  and insert:
    6         Section 1. Present paragraph (c) of subsection (4) of
    7  section 395.402, Florida Statutes, is redesignated as paragraph
    8  (d), and a new paragraph (c) is added to that subsection, to
    9  read:
   10         395.402 Trauma service areas; number and location of trauma
   11  centers.—
   12         (4) Annually thereafter, the department shall review the
   13  assignment of the 67 counties to trauma service areas, in
   14  addition to the requirements of paragraphs (2)(b)-(g) and
   15  subsection (3). County assignments are made for the purpose of
   16  developing a system of trauma centers. Revisions made by the
   17  department shall take into consideration the recommendations
   18  made as part of the regional trauma system plans approved by the
   19  department and the recommendations made as part of the state
   20  trauma system plan. In cases where a trauma service area is
   21  located within the boundaries of more than one trauma region,
   22  the trauma service area’s needs, response capability, and system
   23  requirements shall be considered by each trauma region served by
   24  that trauma service area in its regional system plan. Until the
   25  department completes the February 2005 assessment, the
   26  assignment of counties shall remain as established in this
   27  section.
   28         (c)In any trauma service area in which the department has
   29  designated or provisionally approved a total of one Level I or
   30  Level II trauma center and such trauma center ceases operation
   31  after July 1, 2015, and there is no other trauma center in the
   32  trauma service area, a need for an additional trauma center
   33  shall immediately be established. A hospital within such trauma
   34  service area may submit an application to operate as a Level I
   35  or Level II trauma center at any time after the pre-existing
   36  trauma center ceases operation without regard to whether the
   37  hospital filed a letter of intent to operate as a trauma center.
   38  Because such an application is not submitted within the review
   39  cycle established in this part, the dates established in this
   40  part are not applicable to an application submitted under this
   41  paragraph. For an application submitted under this paragraph,
   42  the department shall conduct a provisional review to determine
   43  whether the application has the critical elements required for a
   44  trauma center within 30 days after receiving the completed
   45  application and conduct the in-depth evaluation of the
   46  application within 5 months after receiving the completed
   47  application. The department shall conduct the onsite visits by a
   48  review team of out-of-state experts within 11 months after
   49  receiving the completed application and make a decision whether
   50  the hospital is selected as a trauma center within 12 months
   51  after receiving the completed application, unless the hospital
   52  seeks and obtains an extension of its provisional status, in
   53  which case the department may extend the provisional status of
   54  the application for an additional 6 months. An application
   55  submitted under this paragraph must comply with all other
   56  provisions of this part. The department must comply with the
   57  dates and timeframes set forth in this paragraph for
   58  administrative review and action on applications submitted under
   59  this paragraph.
   60         Section 2. Subsection (7) of section 400.474, Florida
   61  Statutes, is amended to read:
   62         400.474 Administrative penalties.—
   63         (7) A home health agency shall submit to the agency, with
   64  each license renewal application, the number of patients who
   65  receive home health services from the home health agency on the
   66  day that the license renewal application is filed, within 15
   67  days after the end of each calendar quarter, a written report
   68  that includes the following data as they existed on the last day
   69  of the quarter:
   70         (a) The number of insulin-dependent diabetic patients who
   71  receive insulin-injection services from the home health agency.
   72         (b) The number of patients who receive both home health
   73  services from the home health agency and hospice services.
   74         (c) The number of patients who receive home health services
   75  from the home health agency.
   76         (d) The name and license number of each nurse whose primary
   77  job responsibility is to provide home health services to
   78  patients and who received remuneration from the home health
   79  agency in excess of $25,000 during the calendar quarter.
   81         If the home health agency fails to submit the written
   82  quarterly report within 15 days after the end of each calendar
   83  quarter, the Agency for Health Care Administration shall impose
   84  a fine against the home health agency in the amount of $200 per
   85  day until the Agency for Health Care Administration receives the
   86  report, except that the total fine imposed pursuant to this
   87  subsection may not exceed $5,000 per quarter. A home health
   88  agency is exempt from submission of the report and the
   89  imposition of the fine if it is not a Medicaid or Medicare
   90  provider or if it does not share a controlling interest with a
   91  licensee, as defined in s. 408.803, which bills the Florida
   92  Medicaid program or the Medicare program.
   93         Section 3. Paragraph (t) is added to subsection (3) of
   94  section 408.036, Florida Statutes, to read:
   95         408.036 Projects subject to review; exemptions.—
   96         (3) EXEMPTIONS.—Upon request, the following projects are
   97  subject to exemption from the provisions of subsection (1):
   98         (t) For the establishment of a health care facility or
   99  project that meets all of the following criteria:
  100         1. The applicant was previously licensed within the past 21
  101  days as a health care facility or provider that is subject to
  102  subsection (1).
  103         2. The applicant failed to submit a renewal application and
  104  the license expired on or after January 1, 2015.
  105         3. The applicant does not have a license denial or
  106  revocation action pending with the agency at the time of the
  107  request.
  108         4. The applicant’s request is for the same service type,
  109  district, service area, and site for which the applicant was
  110  previously licensed.
  111         5. The applicant’s request, if applicable, includes the
  112  same number and type of beds as were previously licensed.
  113         6. The applicant agrees to the same conditions that were
  114  previously imposed on the certificate of need or on an exemption
  115  related to the applicant’s previously licensed health care
  116  facility or project.
  117         7. The applicant applies for initial licensure as required
  118  under s. 408.806 within 21 days after the agency approves the
  119  exemption request. If the applicant fails to apply in a timely
  120  manner, the exemption expires on the 22nd day following the
  121  agency’s approval of the exemption.
  123         Notwithstanding subparagraph 1., an applicant whose license
  124  expired between January 1, 2015 and the effective date of this
  125  act may apply for an exemption within 30 days of this act
  126  becoming law.
  127         Section 4. Subsection (3) of section 456.44, Florida
  128  Statutes, is amended to read:
  129         456.44 Controlled substance prescribing.—
  130         (3) STANDARDS OF PRACTICE.—The standards of practice in
  131  this section do not supersede the level of care, skill, and
  132  treatment recognized in general law related to health care
  133  licensure.
  134         (a) A complete medical history and a physical examination
  135  must be conducted before beginning any treatment and must be
  136  documented in the medical record. The exact components of the
  137  physical examination shall be left to the judgment of the
  138  clinician who is expected to perform a physical examination
  139  proportionate to the diagnosis that justifies a treatment. The
  140  medical record must, at a minimum, document the nature and
  141  intensity of the pain, current and past treatments for pain,
  142  underlying or coexisting diseases or conditions, the effect of
  143  the pain on physical and psychological function, a review of
  144  previous medical records, previous diagnostic studies, and
  145  history of alcohol and substance abuse. The medical record shall
  146  also document the presence of one or more recognized medical
  147  indications for the use of a controlled substance. Each
  148  registrant must develop a written plan for assessing each
  149  patient’s risk of aberrant drug-related behavior, which may
  150  include patient drug testing. Registrants must assess each
  151  patient’s risk for aberrant drug-related behavior and monitor
  152  that risk on an ongoing basis in accordance with the plan.
  153         (b) Each registrant must develop a written individualized
  154  treatment plan for each patient. The treatment plan shall state
  155  objectives that will be used to determine treatment success,
  156  such as pain relief and improved physical and psychosocial
  157  function, and shall indicate if any further diagnostic
  158  evaluations or other treatments are planned. After treatment
  159  begins, the physician shall adjust drug therapy to the
  160  individual medical needs of each patient. Other treatment
  161  modalities, including a rehabilitation program, shall be
  162  considered depending on the etiology of the pain and the extent
  163  to which the pain is associated with physical and psychosocial
  164  impairment. The interdisciplinary nature of the treatment plan
  165  shall be documented.
  166         (c) The physician shall discuss the risks and benefits of
  167  the use of controlled substances, including the risks of abuse
  168  and addiction, as well as physical dependence and its
  169  consequences, with the patient, persons designated by the
  170  patient, or the patient’s surrogate or guardian if the patient
  171  is incompetent. The physician shall use a written controlled
  172  substance agreement between the physician and the patient
  173  outlining the patient’s responsibilities, including, but not
  174  limited to:
  175         1. Number and frequency of controlled substance
  176  prescriptions and refills.
  177         2. Patient compliance and reasons for which drug therapy
  178  may be discontinued, such as a violation of the agreement.
  179         3. An agreement that controlled substances for the
  180  treatment of chronic nonmalignant pain shall be prescribed by a
  181  single treating physician unless otherwise authorized by the
  182  treating physician and documented in the medical record.
  183         (d) The patient shall be seen by the physician at regular
  184  intervals, not to exceed 3 months, to assess the efficacy of
  185  treatment, ensure that controlled substance therapy remains
  186  indicated, evaluate the patient’s progress toward treatment
  187  objectives, consider adverse drug effects, and review the
  188  etiology of the pain. Continuation or modification of therapy
  189  shall depend on the physician’s evaluation of the patient’s
  190  progress. If treatment goals are not being achieved, despite
  191  medication adjustments, the physician shall reevaluate the
  192  appropriateness of continued treatment. The physician shall
  193  monitor patient compliance in medication usage, related
  194  treatment plans, controlled substance agreements, and
  195  indications of substance abuse or diversion at a minimum of 3
  196  month intervals.
  197         (e) The physician shall refer the patient as necessary for
  198  additional evaluation and treatment in order to achieve
  199  treatment objectives. Special attention shall be given to those
  200  patients who are at risk for misusing their medications and
  201  those whose living arrangements pose a risk for medication
  202  misuse or diversion. The management of pain in patients with a
  203  history of substance abuse or with a comorbid psychiatric
  204  disorder requires extra care, monitoring, and documentation and
  205  requires consultation with or referral to an addiction medicine
  206  specialist or psychiatrist.
  207         (f) A physician registered under this section must maintain
  208  accurate, current, and complete records that are accessible and
  209  readily available for review and comply with the requirements of
  210  this section, the applicable practice act, and applicable board
  211  rules. The medical records must include, but are not limited to:
  212         1. The complete medical history and a physical examination,
  213  including history of drug abuse or dependence.
  214         2. Diagnostic, therapeutic, and laboratory results.
  215         3. Evaluations and consultations.
  216         4. Treatment objectives.
  217         5. Discussion of risks and benefits.
  218         6. Treatments.
  219         7. Medications, including date, type, dosage, and quantity
  220  prescribed.
  221         8. Instructions and agreements.
  222         9. Periodic reviews.
  223         10. Results of any drug testing.
  224         11. A photocopy of the patient’s government-issued photo
  225  identification.
  226         12. If a written prescription for a controlled substance is
  227  given to the patient, a duplicate of the prescription.
  228         13. The physician’s full name presented in a legible
  229  manner.
  230         (g) Patients with signs or symptoms of substance abuse
  231  shall be immediately referred to a board-certified pain
  232  management physician, an addiction medicine specialist, or a
  233  mental health addiction facility as it pertains to drug abuse or
  234  addiction unless the physician is board-certified or board
  235  eligible in pain management. Throughout the period of time
  236  before receiving the consultant’s report, a prescribing
  237  physician shall clearly and completely document medical
  238  justification for continued treatment with controlled substances
  239  and those steps taken to ensure medically appropriate use of
  240  controlled substances by the patient. Upon receipt of the
  241  consultant’s written report, the prescribing physician shall
  242  incorporate the consultant’s recommendations for continuing,
  243  modifying, or discontinuing controlled substance therapy. The
  244  resulting changes in treatment shall be specifically documented
  245  in the patient’s medical record. Evidence or behavioral
  246  indications of diversion shall be followed by discontinuation of
  247  controlled substance therapy, and the patient shall be
  248  discharged, and all results of testing and actions taken by the
  249  physician shall be documented in the patient’s medical record.
  251         This subsection does not apply to a board-eligible or
  252  board-certified anesthesiologist, physiatrist, rheumatologist,
  253  or neurologist, or to a board-certified physician who has
  254  surgical privileges at a hospital or ambulatory surgery center
  255  and primarily provides surgical services. This subsection does
  256  not apply to a board-eligible or board-certified medical
  257  specialist who has also completed a fellowship in pain medicine
  258  approved by the Accreditation Council for Graduate Medical
  259  Education or the American Osteopathic Association, or who is
  260  board eligible or board certified in pain medicine by the
  261  American Board of Pain Medicine or a board approved by the
  262  American Board of Medical Specialties or the American
  263  Osteopathic Association and performs interventional pain
  264  procedures of the type routinely billed using surgical codes.
  265  This subsection does not apply to a physician who prescribes
  266  medically necessary controlled substances for a patient during
  267  an inpatient stay in a hospital licensed under chapter 395 or
  268  for a resident in a facility licensed under part II of chapter
  269  400.
  270         Section 5. This act shall take effect upon becoming a law.
  272  ================= T I T L E  A M E N D M E N T ================
  273  And the title is amended as follows:
  274         Delete lines 79 - 92
  275  and insert:
  276         An act relating to the regulation of health care;
  277         amending s. 395.402, F.S.; providing a determination
  278         of need for an additional trauma center where a
  279         previously existing trauma center has ceased
  280         operation; authorizing a hospital to submit an
  281         application to operate as a Level I or Level II trauma
  282         center under certain circumstances; providing
  283         timeframes for administrative review and action on
  284         applications to operate as a trauma center where a
  285         previously existing trauma center has ceased
  286         operation; providing requirements for such
  287         applications; amending s. 400.474, F.S.; revising the
  288         information that a home health agency is required to
  289         submit to the Agency for Health Care Administration
  290         for license renewal; removing the requirement that a
  291         home health agency submit quarterly reports; amending
  292         s. 408.036, F.S.; providing an exemption from a
  293         certificate-of-need review for applicants that were
  294         previously licensed within a specified period as a
  295         health care facility or provider and that meet certain
  296         criteria; providing an exception for an applicant
  297         whose license expired during a specified time period
  298         to apply for an exemption from the review; amending s.
  299         456.44, F.S.; revising the application of requirements
  300         for standards of practice for certain controlled
  301         substance prescribing; providing an effective date.