Florida Senate - 2011                          SENATOR AMENDMENT
       Bill No. CS/CS/HB 119, 1st Eng.
       
       
       
       
       
       
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                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/AD/2R         .           Floor: CA            
             05/06/2011 08:39 PM       .      05/06/2011 10:49 PM       
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       Senator Latvala moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Subsection (1) of section 83.42, Florida
    6  Statutes, is amended to read:
    7         83.42 Exclusions from application of part.—This part does
    8  not apply to:
    9         (1) Residency or detention in a facility, whether public or
   10  private, when residence or detention is incidental to the
   11  provision of medical, geriatric, educational, counseling,
   12  religious, or similar services. For residents of a facility
   13  licensed under part II of chapter 400, the provisions of s.
   14  400.0255 are the exclusive procedures for all transfers and
   15  discharges.
   16         Section 2. Paragraphs (f) through (k) of subsection (10) of
   17  section 112.0455, Florida Statutes, are redesignated as
   18  paragraphs (e) through (j), respectively, paragraph (e) of
   19  subsection (12) is redesignated as paragraph (d), and present
   20  paragraph (e) of subsection (10), present paragraph (d) of
   21  subsection (12), and paragraph (e) of subsection (14) of that
   22  section are amended to read:
   23         112.0455 Drug-Free Workplace Act.—
   24         (10) EMPLOYER PROTECTION.—
   25         (e) Nothing in this section shall be construed to operate
   26  retroactively, and nothing in this section shall abrogate the
   27  right of an employer under state law to conduct drug tests prior
   28  to January 1, 1990. A drug test conducted by an employer prior
   29  to January 1, 1990, is not subject to this section.
   30         (12) DRUG-TESTING STANDARDS; LABORATORIES.—
   31         (d) The laboratory shall submit to the Agency for Health
   32  Care Administration a monthly report with statistical
   33  information regarding the testing of employees and job
   34  applicants. The reports shall include information on the methods
   35  of analyses conducted, the drugs tested for, the number of
   36  positive and negative results for both initial and confirmation
   37  tests, and any other information deemed appropriate by the
   38  Agency for Health Care Administration. No monthly report shall
   39  identify specific employees or job applicants.
   40         (14) DISCIPLINE REMEDIES.—
   41         (e) Upon resolving an appeal filed pursuant to paragraph
   42  (c), and finding a violation of this section, the commission may
   43  order the following relief:
   44         1. Rescind the disciplinary action, expunge related records
   45  from the personnel file of the employee or job applicant and
   46  reinstate the employee.
   47         2. Order compliance with paragraph (10)(f)(g).
   48         3. Award back pay and benefits.
   49         4. Award the prevailing employee or job applicant the
   50  necessary costs of the appeal, reasonable attorney’s fees, and
   51  expert witness fees.
   52         Section 3. Paragraph (n) of subsection (1) of section
   53  154.11, Florida Statutes, is amended to read:
   54         154.11 Powers of board of trustees.—
   55         (1) The board of trustees of each public health trust shall
   56  be deemed to exercise a public and essential governmental
   57  function of both the state and the county and in furtherance
   58  thereof it shall, subject to limitation by the governing body of
   59  the county in which such board is located, have all of the
   60  powers necessary or convenient to carry out the operation and
   61  governance of designated health care facilities, including, but
   62  without limiting the generality of, the foregoing:
   63         (n) To appoint originally the staff of physicians to
   64  practice in any designated facility owned or operated by the
   65  board and to approve the bylaws and rules to be adopted by the
   66  medical staff of any designated facility owned and operated by
   67  the board, such governing regulations to be in accordance with
   68  the standards of the Joint Commission on the Accreditation of
   69  Hospitals which provide, among other things, for the method of
   70  appointing additional staff members and for the removal of staff
   71  members.
   72         Section 4. Subsection (15) of section 318.21, Florida
   73  Statutes, is amended to read:
   74         318.21 Disposition of civil penalties by county courts.—All
   75  civil penalties received by a county court pursuant to the
   76  provisions of this chapter shall be distributed and paid monthly
   77  as follows:
   78         (15) Of the additional fine assessed under s. 318.18(3)(e)
   79  for a violation of s. 316.1893, 50 percent of the moneys
   80  received from the fines shall be remitted to the Department of
   81  Revenue and deposited into the Brain and Spinal Cord Injury
   82  Trust Fund of Department of Health and shall be appropriated to
   83  the Department of Health Agency for Health Care Administration
   84  as general revenue to provide an enhanced Medicaid payment to
   85  nursing homes that serve Medicaid recipients with brain and
   86  spinal cord injuries that are medically complex and who are
   87  technologically and respiratory dependent. The remaining 50
   88  percent of the moneys received from the enhanced fine imposed
   89  under s. 318.18(3)(e) shall be remitted to the Department of
   90  Revenue and deposited into the Department of Health Emergency
   91  Medical Services Trust Fund to provide financial support to
   92  certified trauma centers in the counties where enhanced penalty
   93  zones are established to ensure the availability and
   94  accessibility of trauma services. Funds deposited into the
   95  Emergency Medical Services Trust Fund under this subsection
   96  shall be allocated as follows:
   97         (a) Fifty percent shall be allocated equally among all
   98  Level I, Level II, and pediatric trauma centers in recognition
   99  of readiness costs for maintaining trauma services.
  100         (b) Fifty percent shall be allocated among Level I, Level
  101  II, and pediatric trauma centers based on each center’s relative
  102  volume of trauma cases as reported in the Department of Health
  103  Trauma Registry.
  104         Section 5. Section 383.325, Florida Statutes, is repealed.
  105         Section 6. Subsection (7) of section 394.4787, Florida
  106  Statutes, is amended to read:
  107         394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and
  108  394.4789.—As used in this section and ss. 394.4786, 394.4788,
  109  and 394.4789:
  110         (7) “Specialty psychiatric hospital” means a hospital
  111  licensed by the agency pursuant to s. 395.002(26)(28) and part
  112  II of chapter 408 as a specialty psychiatric hospital.
  113         Section 7. Subsection (2) of section 394.741, Florida
  114  Statutes, is amended to read:
  115         394.741 Accreditation requirements for providers of
  116  behavioral health care services.—
  117         (2) Notwithstanding any provision of law to the contrary,
  118  accreditation shall be accepted by the agency and department in
  119  lieu of the agency’s and department’s facility licensure onsite
  120  review requirements and shall be accepted as a substitute for
  121  the department’s administrative and program monitoring
  122  requirements, except as required by subsections (3) and (4),
  123  for:
  124         (a) Any organization from which the department purchases
  125  behavioral health care services that is accredited by the Joint
  126  Commission on Accreditation of Healthcare Organizations or the
  127  Council on Accreditation for Children and Family Services, or
  128  has those services that are being purchased by the department
  129  accredited by the Commission on Accreditation of Rehabilitation
  130  Facilities CARF—the Rehabilitation Accreditation Commission.
  131         (b) Any mental health facility licensed by the agency or
  132  any substance abuse component licensed by the department that is
  133  accredited by the Joint Commission on Accreditation of
  134  Healthcare Organizations, the Commission on Accreditation of
  135  Rehabilitation Facilities CARF—the Rehabilitation Accreditation
  136  Commission, or the Council on Accreditation of Children and
  137  Family Services.
  138         (c) Any network of providers from which the department or
  139  the agency purchases behavioral health care services accredited
  140  by the Joint Commission on Accreditation of Healthcare
  141  Organizations, the Commission on Accreditation of Rehabilitation
  142  Facilities CARF—the Rehabilitation Accreditation Commission, the
  143  Council on Accreditation of Children and Family Services, or the
  144  National Committee for Quality Assurance. A provider
  145  organization, which is part of an accredited network, is
  146  afforded the same rights under this part.
  147         Section 8. Present subsections (15) through (32) of section
  148  395.002, Florida Statutes, are renumbered as subsections (14)
  149  through (28), respectively, and present subsections (1), (14),
  150  (24), (30), and (31) and paragraph (c) of present subsection
  151  (28) of that section are amended to read:
  152         395.002 Definitions.—As used in this chapter:
  153         (1) “Accrediting organizations” means nationally recognized
  154  or approved accrediting organizations whose standards
  155  incorporate comparable licensure requirements as determined by
  156  the agency the Joint Commission on Accreditation of Healthcare
  157  Organizations, the American Osteopathic Association, the
  158  Commission on Accreditation of Rehabilitation Facilities, and
  159  the Accreditation Association for Ambulatory Health Care, Inc.
  160         (14) “Initial denial determination” means a determination
  161  by a private review agent that the health care services
  162  furnished or proposed to be furnished to a patient are
  163  inappropriate, not medically necessary, or not reasonable.
  164         (24) “Private review agent” means any person or entity
  165  which performs utilization review services for third-party
  166  payors on a contractual basis for outpatient or inpatient
  167  services. However, the term shall not include full-time
  168  employees, personnel, or staff of health insurers, health
  169  maintenance organizations, or hospitals, or wholly owned
  170  subsidiaries thereof or affiliates under common ownership, when
  171  performing utilization review for their respective hospitals,
  172  health maintenance organizations, or insureds of the same
  173  insurance group. For this purpose, health insurers, health
  174  maintenance organizations, and hospitals, or wholly owned
  175  subsidiaries thereof or affiliates under common ownership,
  176  include such entities engaged as administrators of self
  177  insurance as defined in s. 624.031.
  178         (26)(28) “Specialty hospital” means any facility which
  179  meets the provisions of subsection (12), and which regularly
  180  makes available either:
  181         (c) Intensive residential treatment programs for children
  182  and adolescents as defined in subsection (14) (15).
  183         (30) “Utilization review” means a system for reviewing the
  184  medical necessity or appropriateness in the allocation of health
  185  care resources of hospital services given or proposed to be
  186  given to a patient or group of patients.
  187         (31) “Utilization review plan” means a description of the
  188  policies and procedures governing utilization review activities
  189  performed by a private review agent.
  190         Section 9. Paragraph (c) of subsection (1) and paragraph
  191  (b) of subsection (2) of section 395.003, Florida Statutes, are
  192  amended to read:
  193         395.003 Licensure; denial, suspension, and revocation.—
  194         (1)
  195         (c) Until July 1, 2006, additional emergency departments
  196  located off the premises of licensed hospitals may not be
  197  authorized by the agency.
  198         (2)
  199         (b) The agency shall, at the request of a licensee that is
  200  a teaching hospital as defined in s. 408.07(45), issue a single
  201  license to a licensee for facilities that have been previously
  202  licensed as separate premises, provided such separately licensed
  203  facilities, taken together, constitute the same premises as
  204  defined in s. 395.002(22)(23). Such license for the single
  205  premises shall include all of the beds, services, and programs
  206  that were previously included on the licenses for the separate
  207  premises. The granting of a single license under this paragraph
  208  shall not in any manner reduce the number of beds, services, or
  209  programs operated by the licensee.
  210         Section 10. Subsection (3) of section 395.0161, Florida
  211  Statutes, is amended to read:
  212         395.0161 Licensure inspection.—
  213         (3) In accordance with s. 408.805, an applicant or licensee
  214  shall pay a fee for each license application submitted under
  215  this part, part II of chapter 408, and applicable rules. With
  216  the exception of state-operated licensed facilities, each
  217  facility licensed under this part shall pay to the agency, at
  218  the time of inspection, the following fees:
  219         (a) Inspection for licensure.—A fee shall be paid which is
  220  not less than $8 per hospital bed, nor more than $12 per
  221  hospital bed, except that the minimum fee shall be $400 per
  222  facility.
  223         (b) Inspection for lifesafety only.—A fee shall be paid
  224  which is not less than 75 cents per hospital bed, nor more than
  225  $1.50 per hospital bed, except that the minimum fee shall be $40
  226  per facility.
  227         Section 11. Paragraph (e) of subsection (2) and subsection
  228  (4) of section 395.0193, Florida Statutes, are amended to read:
  229         395.0193 Licensed facilities; peer review; disciplinary
  230  powers; agency or partnership with physicians.—
  231         (2) Each licensed facility, as a condition of licensure,
  232  shall provide for peer review of physicians who deliver health
  233  care services at the facility. Each licensed facility shall
  234  develop written, binding procedures by which such peer review
  235  shall be conducted. Such procedures shall include:
  236         (e) Recording of agendas and minutes which do not contain
  237  confidential material, for review by the Division of Medical
  238  Quality Assurance of the department Health Quality Assurance of
  239  the agency.
  240         (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
  241  actions taken under subsection (3) shall be reported in writing
  242  to the Division of Medical Quality Assurance of the department
  243  Health Quality Assurance of the agency within 30 working days
  244  after its initial occurrence, regardless of the pendency of
  245  appeals to the governing board of the hospital. The notification
  246  shall identify the disciplined practitioner, the action taken,
  247  and the reason for such action. All final disciplinary actions
  248  taken under subsection (3), if different from those which were
  249  reported to the department agency within 30 days after the
  250  initial occurrence, shall be reported within 10 working days to
  251  the Division of Medical Quality Assurance of the department
  252  Health Quality Assurance of the agency in writing and shall
  253  specify the disciplinary action taken and the specific grounds
  254  therefor. The division shall review each report and determine
  255  whether it potentially involved conduct by the licensee that is
  256  subject to disciplinary action, in which case s. 456.073 shall
  257  apply. The reports are not subject to inspection under s.
  258  119.07(1) even if the division’s investigation results in a
  259  finding of probable cause.
  260         Section 12. Section 395.1023, Florida Statutes, is amended
  261  to read:
  262         395.1023 Child abuse and neglect cases; duties.—Each
  263  licensed facility shall adopt a protocol that, at a minimum,
  264  requires the facility to:
  265         (1) Incorporate a facility policy that every staff member
  266  has an affirmative duty to report, pursuant to chapter 39, any
  267  actual or suspected case of child abuse, abandonment, or
  268  neglect; and
  269         (2) In any case involving suspected child abuse,
  270  abandonment, or neglect, designate, at the request of the
  271  Department of Children and Family Services, a staff physician to
  272  act as a liaison between the hospital and the Department of
  273  Children and Family Services office which is investigating the
  274  suspected abuse, abandonment, or neglect, and the child
  275  protection team, as defined in s. 39.01, when the case is
  276  referred to such a team.
  277  
  278  Each general hospital and appropriate specialty hospital shall
  279  comply with the provisions of this section and shall notify the
  280  agency and the Department of Children and Family Services of its
  281  compliance by sending a copy of its policy to the agency and the
  282  Department of Children and Family Services as required by rule.
  283  The failure by a general hospital or appropriate specialty
  284  hospital to comply shall be punished by a fine not exceeding
  285  $1,000, to be fixed, imposed, and collected by the agency. Each
  286  day in violation is considered a separate offense.
  287         Section 13. Subsection (2) and paragraph (d) of subsection
  288  (3) of section 395.1041, Florida Statutes, are amended to read:
  289         395.1041 Access to emergency services and care.—
  290         (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
  291  shall establish and maintain an inventory of hospitals with
  292  emergency services. The inventory shall list all services within
  293  the service capability of the hospital, and such services shall
  294  appear on the face of the hospital license. Each hospital having
  295  emergency services shall notify the agency of its service
  296  capability in the manner and form prescribed by the agency. The
  297  agency shall use the inventory to assist emergency medical
  298  services providers and others in locating appropriate emergency
  299  medical care. The inventory shall also be made available to the
  300  general public. On or before August 1, 1992, the agency shall
  301  request that each hospital identify the services which are
  302  within its service capability. On or before November 1, 1992,
  303  the agency shall notify each hospital of the service capability
  304  to be included in the inventory. The hospital has 15 days from
  305  the date of receipt to respond to the notice. By December 1,
  306  1992, the agency shall publish a final inventory. Each hospital
  307  shall reaffirm its service capability when its license is
  308  renewed and shall notify the agency of the addition of a new
  309  service or the termination of a service prior to a change in its
  310  service capability.
  311         (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
  312  FACILITY OR HEALTH CARE PERSONNEL.—
  313         (d)1. Every hospital shall ensure the provision of services
  314  within the service capability of the hospital, at all times,
  315  either directly or indirectly through an arrangement with
  316  another hospital, through an arrangement with one or more
  317  physicians, or as otherwise made through prior arrangements. A
  318  hospital may enter into an agreement with another hospital for
  319  purposes of meeting its service capability requirement, and
  320  appropriate compensation or other reasonable conditions may be
  321  negotiated for these backup services.
  322         2. If any arrangement requires the provision of emergency
  323  medical transportation, such arrangement must be made in
  324  consultation with the applicable provider and may not require
  325  the emergency medical service provider to provide transportation
  326  that is outside the routine service area of that provider or in
  327  a manner that impairs the ability of the emergency medical
  328  service provider to timely respond to prehospital emergency
  329  calls.
  330         3. A hospital shall not be required to ensure service
  331  capability at all times as required in subparagraph 1. if, prior
  332  to the receiving of any patient needing such service capability,
  333  such hospital has demonstrated to the agency that it lacks the
  334  ability to ensure such capability and it has exhausted all
  335  reasonable efforts to ensure such capability through backup
  336  arrangements. In reviewing a hospital’s demonstration of lack of
  337  ability to ensure service capability, the agency shall consider
  338  factors relevant to the particular case, including the
  339  following:
  340         a. Number and proximity of hospitals with the same service
  341  capability.
  342         b. Number, type, credentials, and privileges of
  343  specialists.
  344         c. Frequency of procedures.
  345         d. Size of hospital.
  346         4. The agency shall publish proposed rules implementing a
  347  reasonable exemption procedure by November 1, 1992. Subparagraph
  348  1. shall become effective upon the effective date of said rules
  349  or January 31, 1993, whichever is earlier. For a period not to
  350  exceed 1 year from the effective date of subparagraph 1., a
  351  hospital requesting an exemption shall be deemed to be exempt
  352  from offering the service until the agency initially acts to
  353  deny or grant the original request. The agency has 45 days after
  354  from the date of receipt of the request to approve or deny the
  355  request. After the first year from the effective date of
  356  subparagraph 1., If the agency fails to initially act within
  357  that the time period, the hospital is deemed to be exempt from
  358  offering the service until the agency initially acts to deny the
  359  request.
  360         Section 14. Section 395.1046, Florida Statutes, is
  361  repealed.
  362         Section 15. Paragraphs (b) and (e) of subsection (1) of
  363  section 395.1055, Florida Statutes, are amended to read:
  364         395.1055 Rules and enforcement.—
  365         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
  366  and 120.54 to implement the provisions of this part, which shall
  367  include reasonable and fair minimum standards for ensuring that:
  368         (b) Infection control, housekeeping, sanitary conditions,
  369  and medical record procedures that will adequately protect
  370  patient care and safety are established and implemented. These
  371  procedures shall require housekeeping and sanitation staff to
  372  wear masks and gloves when cleaning patient rooms and
  373  disinfecting environmental surfaces in patient rooms in
  374  accordance with the time instructions on the label of the
  375  disinfectant used by the hospital. The agency may impose an
  376  administrative fine for each day that a violation of this
  377  paragraph occurs.
  378         (e) Licensed facility beds conform to minimum space,
  379  equipment, and furnishings standards as specified by the agency,
  380  the Florida Building Code, and the Florida Fire Prevention Code
  381  department.
  382         Section 16. Subsection (1) of section 395.10972, Florida
  383  Statutes, is amended to read:
  384         395.10972 Health Care Risk Manager Advisory Council.—The
  385  Secretary of Health Care Administration may appoint a seven
  386  member advisory council to advise the agency on matters
  387  pertaining to health care risk managers. The members of the
  388  council shall serve at the pleasure of the secretary. The
  389  council shall designate a chair. The council shall meet at the
  390  call of the secretary or at those times as may be required by
  391  rule of the agency. The members of the advisory council shall
  392  receive no compensation for their services, but shall be
  393  reimbursed for travel expenses as provided in s. 112.061. The
  394  council shall consist of individuals representing the following
  395  areas:
  396         (1) Two shall be active health care risk managers,
  397  including one risk manager who is recommended by and a member of
  398  the Florida Society for of Healthcare Risk Management and
  399  Patient Safety.
  400         Section 17. Subsection (3) of section 395.2050, Florida
  401  Statutes, is amended to read:
  402         395.2050 Routine inquiry for organ and tissue donation;
  403  certification for procurement activities; death records review.—
  404         (3) Each organ procurement organization designated by the
  405  federal Centers for Medicare and Medicaid Services Health Care
  406  Financing Administration and licensed by the state shall conduct
  407  an annual death records review in the organ procurement
  408  organization’s affiliated donor hospitals. The organ procurement
  409  organization shall enlist the services of every Florida licensed
  410  tissue bank and eye bank affiliated with or providing service to
  411  the donor hospital and operating in the same service area to
  412  participate in the death records review.
  413         Section 18. Subsection (2) of section 395.3036, Florida
  414  Statutes, is amended to read:
  415         395.3036 Confidentiality of records and meetings of
  416  corporations that lease public hospitals or other public health
  417  care facilities.—The records of a private corporation that
  418  leases a public hospital or other public health care facility
  419  are confidential and exempt from the provisions of s. 119.07(1)
  420  and s. 24(a), Art. I of the State Constitution, and the meetings
  421  of the governing board of a private corporation are exempt from
  422  s. 286.011 and s. 24(b), Art. I of the State Constitution when
  423  the public lessor complies with the public finance
  424  accountability provisions of s. 155.40(5) with respect to the
  425  transfer of any public funds to the private lessee and when the
  426  private lessee meets at least three of the five following
  427  criteria:
  428         (2) The public lessor and the private lessee do not
  429  commingle any of their funds in any account maintained by either
  430  of them, other than the payment of the rent and administrative
  431  fees or the transfer of funds pursuant to s. 155.40 subsection
  432  (2).
  433         Section 19. Section 395.3037, Florida Statutes, is
  434  repealed.
  435         Section 20. Subsections (1), (4), and (5) of section
  436  395.3038, Florida Statutes, are amended to read:
  437         395.3038 State-listed primary stroke centers and
  438  comprehensive stroke centers; notification of hospitals.—
  439         (1) The agency shall make available on its website and to
  440  the department a list of the name and address of each hospital
  441  that meets the criteria for a primary stroke center and the name
  442  and address of each hospital that meets the criteria for a
  443  comprehensive stroke center. The list of primary and
  444  comprehensive stroke centers shall include only those hospitals
  445  that attest in an affidavit submitted to the agency that the
  446  hospital meets the named criteria, or those hospitals that
  447  attest in an affidavit submitted to the agency that the hospital
  448  is certified as a primary or a comprehensive stroke center by
  449  the Joint Commission on Accreditation of Healthcare
  450  Organizations.
  451         (4) The agency shall adopt by rule criteria for a primary
  452  stroke center which are substantially similar to the
  453  certification standards for primary stroke centers of the Joint
  454  Commission on Accreditation of Healthcare Organizations.
  455         (5) The agency shall adopt by rule criteria for a
  456  comprehensive stroke center. However, if the Joint Commission on
  457  Accreditation of Healthcare Organizations establishes criteria
  458  for a comprehensive stroke center, the agency shall establish
  459  criteria for a comprehensive stroke center which are
  460  substantially similar to those criteria established by the Joint
  461  Commission on Accreditation of Healthcare Organizations.
  462         Section 21. Paragraph (d) of subsection (2) of section
  463  395.4025, Florida Statutes, is amended to read:
  464         395.4025 Trauma centers; selection; quality assurance;
  465  records.—
  466         (2)
  467         (d)1. Notwithstanding other provisions in this section, the
  468  department may grant up to an additional 18 months to a hospital
  469  applicant that is unable to meet all requirements as provided in
  470  paragraph (c) at the time of application if the number of
  471  applicants in the service area in which the applicant is located
  472  is equal to or less than the service area allocation, as
  473  provided by rule of the department. An applicant that is granted
  474  additional time pursuant to this paragraph shall submit a plan
  475  for departmental approval which includes timelines and
  476  activities that the applicant proposes to complete in order to
  477  meet application requirements. Any applicant that demonstrates
  478  an ongoing effort to complete the activities within the
  479  timelines outlined in the plan shall be included in the number
  480  of trauma centers at such time that the department has conducted
  481  a provisional review of the application and has determined that
  482  the application is complete and that the hospital has the
  483  critical elements required for a trauma center. An applicant
  484  that has received an additional 18 months pursuant to this
  485  paragraph shall be granted up to two additional 6-month
  486  extensions to meet all requirements as provided in paragraph
  487  (c), if construction related to a critical element is delayed as
  488  a result of governmental action or inaction with respect to
  489  regulations or permitting, and the applicant has made a good
  490  faith effort to comply with the applicable regulations or obtain
  491  the required permits.
  492         2. Timeframes provided in subsections (1)-(8) shall be
  493  stayed until the department determines that the application is
  494  complete and that the hospital has the critical elements
  495  required for a trauma center.
  496         Section 22. Paragraph (e) of subsection (2) of section
  497  395.602, Florida Statutes, is amended to read:
  498         395.602 Rural hospitals.—
  499         (2) DEFINITIONS.—As used in this part:
  500         (e) “Rural hospital” means an acute care hospital licensed
  501  under this chapter, having 100 or fewer licensed beds and an
  502  emergency room, which is:
  503         1. The sole provider within a county with a population
  504  density of no greater than 100 persons per square mile;
  505         2. An acute care hospital, in a county with a population
  506  density of no greater than 100 persons per square mile, which is
  507  at least 30 minutes of travel time, on normally traveled roads
  508  under normal traffic conditions, from any other acute care
  509  hospital within the same county;
  510         3. A hospital supported by a tax district or subdistrict
  511  whose boundaries encompass a population of 100 persons or fewer
  512  per square mile;
  513         4. A hospital in a constitutional charter county with a
  514  population of over 1 million persons that has imposed a local
  515  option health service tax pursuant to law and in an area that
  516  was directly impacted by a catastrophic event on August 24,
  517  1992, for which the Governor of Florida declared a state of
  518  emergency pursuant to chapter 125, and has 120 beds or less that
  519  serves an agricultural community with an emergency room
  520  utilization of no less than 20,000 visits and a Medicaid
  521  inpatient utilization rate greater than 15 percent;
  522         4.5. A hospital with a service area that has a population
  523  of 100 persons or fewer per square mile. As used in this
  524  subparagraph, the term “service area” means the fewest number of
  525  zip codes that account for 75 percent of the hospital’s
  526  discharges for the most recent 5-year period, based on
  527  information available from the hospital inpatient discharge
  528  database in the Florida Center for Health Information and Policy
  529  Analysis at the Agency for Health Care Administration; or
  530         5.6. A hospital designated as a critical access hospital,
  531  as defined in s. 408.07(15).
  532  
  533  Population densities used in this paragraph must be based upon
  534  the most recently completed United States census. A hospital
  535  that received funds under s. 409.9116 for a quarter beginning no
  536  later than July 1, 2002, is deemed to have been and shall
  537  continue to be a rural hospital from that date through June 30,
  538  2015, if the hospital continues to have 100 or fewer licensed
  539  beds and an emergency room, or meets the criteria of
  540  subparagraph 4. An acute care hospital that has not previously
  541  been designated as a rural hospital and that meets the criteria
  542  of this paragraph shall be granted such designation upon
  543  application, including supporting documentation to the Agency
  544  for Health Care Administration.
  545         Section 23. Subsections (8) and (16) of section 400.021,
  546  Florida Statutes, are amended to read:
  547         400.021 Definitions.—When used in this part, unless the
  548  context otherwise requires, the term:
  549         (8) “Geriatric outpatient clinic” means a site for
  550  providing outpatient health care to persons 60 years of age or
  551  older, which is staffed by a registered nurse or a physician
  552  assistant, or a licensed practical nurse under the direct
  553  supervision of a registered nurse, advanced registered nurse
  554  practitioner, physician assistant, or physician.
  555         (16) “Resident care plan” means a written plan developed,
  556  maintained, and reviewed not less than quarterly by a registered
  557  nurse, with participation from other facility staff and the
  558  resident or his or her designee or legal representative, which
  559  includes a comprehensive assessment of the needs of an
  560  individual resident; the type and frequency of services required
  561  to provide the necessary care for the resident to attain or
  562  maintain the highest practicable physical, mental, and
  563  psychosocial well-being; a listing of services provided within
  564  or outside the facility to meet those needs; and an explanation
  565  of service goals. The resident care plan must be signed by the
  566  director of nursing or another registered nurse employed by the
  567  facility to whom institutional responsibilities have been
  568  delegated and by the resident, the resident’s designee, or the
  569  resident’s legal representative. The facility may not use an
  570  agency or temporary registered nurse to satisfy the foregoing
  571  requirement and must document the institutional responsibilities
  572  that have been delegated to the registered nurse.
  573         Section 24. Paragraph (g) of subsection (2) of section
  574  400.0239, Florida Statutes, is amended to read:
  575         400.0239 Quality of Long-Term Care Facility Improvement
  576  Trust Fund.—
  577         (2) Expenditures from the trust fund shall be allowable for
  578  direct support of the following:
  579         (g) Other initiatives authorized by the Centers for
  580  Medicare and Medicaid Services for the use of federal civil
  581  monetary penalties, including projects recommended through the
  582  Medicaid “Up-or-Out” Quality of Care Contract Management Program
  583  pursuant to s. 400.148.
  584         Section 25. Subsection (15) of section 400.0255, Florida
  585  Statutes, is amended to read
  586         400.0255 Resident transfer or discharge; requirements and
  587  procedures; hearings.—
  588         (15)(a) The department’s Office of Appeals Hearings shall
  589  conduct hearings under this section. The office shall notify the
  590  facility of a resident’s request for a hearing.
  591         (b) The department shall, by rule, establish procedures to
  592  be used for fair hearings requested by residents. These
  593  procedures shall be equivalent to the procedures used for fair
  594  hearings for other Medicaid cases appearing in s. 409.285 and
  595  applicable rules, chapter 10-2, part VI, Florida Administrative
  596  Code. The burden of proof must be clear and convincing evidence.
  597  A hearing decision must be rendered within 90 days after receipt
  598  of the request for hearing.
  599         (c) If the hearing decision is favorable to the resident
  600  who has been transferred or discharged, the resident must be
  601  readmitted to the facility’s first available bed.
  602         (d) The decision of the hearing officer shall be final. Any
  603  aggrieved party may appeal the decision to the district court of
  604  appeal in the appellate district where the facility is located.
  605  Review procedures shall be conducted in accordance with the
  606  Florida Rules of Appellate Procedure.
  607         Section 26. Subsection (2) of section 400.063, Florida
  608  Statutes, is amended to read:
  609         400.063 Resident protection.—
  610         (2) The agency is authorized to establish for each
  611  facility, subject to intervention by the agency, a separate bank
  612  account for the deposit to the credit of the agency of any
  613  moneys received from the Health Care Trust Fund or any other
  614  moneys received for the maintenance and care of residents in the
  615  facility, and the agency is authorized to disburse moneys from
  616  such account to pay obligations incurred for the purposes of
  617  this section. The agency is authorized to requisition moneys
  618  from the Health Care Trust Fund in advance of an actual need for
  619  cash on the basis of an estimate by the agency of moneys to be
  620  spent under the authority of this section. Any bank account
  621  established under this section need not be approved in advance
  622  of its creation as required by s. 17.58, but shall be secured by
  623  depository insurance equal to or greater than the balance of
  624  such account or by the pledge of collateral security in
  625  conformance with criteria established in s. 18.11. The agency
  626  shall notify the Chief Financial Officer of any such account so
  627  established and shall make a quarterly accounting to the Chief
  628  Financial Officer for all moneys deposited in such account.
  629         Section 27. Subsections (1) and (5) of section 400.071,
  630  Florida Statutes, are amended to read:
  631         400.071 Application for license.—
  632         (1) In addition to the requirements of part II of chapter
  633  408, the application for a license shall be under oath and must
  634  contain the following:
  635         (a) The location of the facility for which a license is
  636  sought and an indication, as in the original application, that
  637  such location conforms to the local zoning ordinances.
  638         (b) A signed affidavit disclosing any financial or
  639  ownership interest that a controlling interest as defined in
  640  part II of chapter 408 has held in the last 5 years in any
  641  entity licensed by this state or any other state to provide
  642  health or residential care which has closed voluntarily or
  643  involuntarily; has filed for bankruptcy; has had a receiver
  644  appointed; has had a license denied, suspended, or revoked; or
  645  has had an injunction issued against it which was initiated by a
  646  regulatory agency. The affidavit must disclose the reason any
  647  such entity was closed, whether voluntarily or involuntarily.
  648         (c) The total number of beds and the total number of
  649  Medicare and Medicaid certified beds.
  650         (b)(d) Information relating to the applicant and employees
  651  which the agency requires by rule. The applicant must
  652  demonstrate that sufficient numbers of qualified staff, by
  653  training or experience, will be employed to properly care for
  654  the type and number of residents who will reside in the
  655  facility.
  656         (e) Copies of any civil verdict or judgment involving the
  657  applicant rendered within the 10 years preceding the
  658  application, relating to medical negligence, violation of
  659  residents’ rights, or wrongful death. As a condition of
  660  licensure, the licensee agrees to provide to the agency copies
  661  of any new verdict or judgment involving the applicant, relating
  662  to such matters, within 30 days after filing with the clerk of
  663  the court. The information required in this paragraph shall be
  664  maintained in the facility’s licensure file and in an agency
  665  database which is available as a public record.
  666         (5) As a condition of licensure, each facility must
  667  establish and submit with its application a plan for quality
  668  assurance and for conducting risk management.
  669         Section 28. Section 400.0712, Florida Statutes, is amended
  670  to read:
  671         400.0712 Application for inactive license.—
  672         (1) As specified in this section, the agency may issue an
  673  inactive license to a nursing home facility for all or a portion
  674  of its beds. Any request by a licensee that a nursing home or
  675  portion of a nursing home become inactive must be submitted to
  676  the agency in the approved format. The facility may not initiate
  677  any suspension of services, notify residents, or initiate
  678  inactivity before receiving approval from the agency; and a
  679  licensee that violates this provision may not be issued an
  680  inactive license.
  681         (1)(2)In addition to the powers granted under part II of
  682  chapter 408, the agency may issue an inactive license for a
  683  portion of the total beds to a nursing home that chooses to use
  684  an unoccupied contiguous portion of the facility for an
  685  alternative use to meet the needs of elderly persons through the
  686  use of less restrictive, less institutional services.
  687         (a) An inactive license issued under this subsection may be
  688  granted for a period not to exceed the current licensure
  689  expiration date but may be renewed by the agency at the time of
  690  licensure renewal.
  691         (b) A request to extend the inactive license must be
  692  submitted to the agency in the approved format and approved by
  693  the agency in writing.
  694         (c) Nursing homes that receive an inactive license to
  695  provide alternative services shall not receive preference for
  696  participation in the Assisted Living for the Elderly Medicaid
  697  waiver.
  698         (2)(3) The agency shall adopt rules pursuant to ss.
  699  120.536(1) and 120.54 necessary to implement this section.
  700         Section 29. Section 400.111, Florida Statutes, is amended
  701  to read:
  702         400.111 Disclosure of controlling interest.—In addition to
  703  the requirements of part II of chapter 408, when requested by
  704  the agency, the licensee shall submit a signed affidavit
  705  disclosing any financial or ownership interest that a
  706  controlling interest has held within the last 5 years in any
  707  entity licensed by the state or any other state to provide
  708  health or residential care which entity has closed voluntarily
  709  or involuntarily; has filed for bankruptcy; has had a receiver
  710  appointed; has had a license denied, suspended, or revoked; or
  711  has had an injunction issued against it which was initiated by a
  712  regulatory agency. The affidavit must disclose the reason such
  713  entity was closed, whether voluntarily or involuntarily.
  714         Section 30. Subsection (2) of section 400.1183, Florida
  715  Statutes, is amended to read:
  716         400.1183 Resident grievance procedures.—
  717         (2) Each facility shall maintain records of all grievances
  718  and shall retain a log for agency inspection of report to the
  719  agency at the time of relicensure the total number of grievances
  720  handled during the prior licensure period, a categorization of
  721  the cases underlying the grievances, and the final disposition
  722  of the grievances.
  723         Section 31. Section 400.141, Florida Statutes, is amended
  724  to read:
  725         400.141 Administration and management of nursing home
  726  facilities.—
  727         (1) Every licensed facility shall comply with all
  728  applicable standards and rules of the agency and shall:
  729         (a) Be under the administrative direction and charge of a
  730  licensed administrator.
  731         (b) Appoint a medical director licensed pursuant to chapter
  732  458 or chapter 459. The agency may establish by rule more
  733  specific criteria for the appointment of a medical director.
  734         (c) Have available the regular, consultative, and emergency
  735  services of physicians licensed by the state.
  736         (d) Provide for resident use of a community pharmacy as
  737  specified in s. 400.022(1)(q). Any other law to the contrary
  738  notwithstanding, a registered pharmacist licensed in Florida,
  739  that is under contract with a facility licensed under this
  740  chapter or chapter 429, shall repackage a nursing facility
  741  resident’s bulk prescription medication which has been packaged
  742  by another pharmacist licensed in any state in the United States
  743  into a unit dose system compatible with the system used by the
  744  nursing facility, if the pharmacist is requested to offer such
  745  service. In order to be eligible for the repackaging, a resident
  746  or the resident’s spouse must receive prescription medication
  747  benefits provided through a former employer as part of his or
  748  her retirement benefits, a qualified pension plan as specified
  749  in s. 4972 of the Internal Revenue Code, a federal retirement
  750  program as specified under 5 C.F.R. s. 831, or a long-term care
  751  policy as defined in s. 627.9404(1). A pharmacist who correctly
  752  repackages and relabels the medication and the nursing facility
  753  which correctly administers such repackaged medication under
  754  this paragraph may not be held liable in any civil or
  755  administrative action arising from the repackaging. In order to
  756  be eligible for the repackaging, a nursing facility resident for
  757  whom the medication is to be repackaged shall sign an informed
  758  consent form provided by the facility which includes an
  759  explanation of the repackaging process and which notifies the
  760  resident of the immunities from liability provided in this
  761  paragraph. A pharmacist who repackages and relabels prescription
  762  medications, as authorized under this paragraph, may charge a
  763  reasonable fee for costs resulting from the implementation of
  764  this provision.
  765         (e) Provide for the access of the facility residents to
  766  dental and other health-related services, recreational services,
  767  rehabilitative services, and social work services appropriate to
  768  their needs and conditions and not directly furnished by the
  769  licensee. When a geriatric outpatient nurse clinic is conducted
  770  in accordance with rules adopted by the agency, outpatients
  771  attending such clinic shall not be counted as part of the
  772  general resident population of the nursing home facility, nor
  773  shall the nursing staff of the geriatric outpatient clinic be
  774  counted as part of the nursing staff of the facility, until the
  775  outpatient clinic load exceeds 15 a day.
  776         (f) Be allowed and encouraged by the agency to provide
  777  other needed services under certain conditions. If the facility
  778  has a standard licensure status, and has had no class I or class
  779  II deficiencies during the past 2 years or has been awarded a
  780  Gold Seal under the program established in s. 400.235, it may be
  781  encouraged by the agency to provide services, including, but not
  782  limited to, respite and adult day services, which enable
  783  individuals to move in and out of the facility. A facility is
  784  not subject to any additional licensure requirements for
  785  providing these services, under the following conditions:.
  786         1. Respite care may be offered to persons in need of short
  787  term or temporary nursing home services. For each person
  788  admitted under the respite care program, the facility licensee
  789  must:
  790         a. Have a written abbreviated plan of care that, at a
  791  minimum, includes nutritional requirements, medication orders,
  792  physician orders, nursing assessments, and dietary preferences.
  793  The nursing or physician assessments may take the place of all
  794  other assessments required for full-time residents.
  795         b. Have a contract that, at a minimum, specifies the
  796  services to be provided to the respite resident, including
  797  charges for services, activities, equipment, emergency medical
  798  services, and the administration of medications. If multiple
  799  respite admissions for a single person are anticipated, the
  800  original contract is valid for 1 year after the date of
  801  execution.
  802         c. Ensure that each resident is released to his or her
  803  caregiver or an individual designated in writing by the
  804  caregiver.
  805         2. A person admitted under the respite care program is:
  806         a. Exempt from requirements in rule related to discharge
  807  planning.
  808         b. Covered by the residents’ rights set forth in s.
  809  400.022(1)(a)-(o) and (r)-(t). Funds or property of the resident
  810  shall not be considered trust funds subject to the requirements
  811  of s. 400.022(1)(h) until the resident has been in the facility
  812  for more than 14 consecutive days.
  813         c. Allowed to use his or her personal medications for the
  814  respite stay if permitted by facility policy. The facility must
  815  obtain a physician’s order for the medications. The caregiver
  816  may provide information regarding the medications as part of the
  817  nursing assessment and that information must agree with the
  818  physician’s order. Medications shall be released with the
  819  resident upon discharge in accordance with current physician’s
  820  orders.
  821         3. A person receiving respite care is entitled to reside in
  822  the facility for a total of 60 days within a contract year or
  823  within a calendar year if the contract is for less than 12
  824  months. However, each single stay may not exceed 14 days. If a
  825  stay exceeds 14 consecutive days, the facility must comply with
  826  all assessment and care planning requirements applicable to
  827  nursing home residents.
  828         4. A person receiving respite care must reside in a
  829  licensed nursing home bed.
  830         5. A prospective respite resident must provide medical
  831  information from a physician, physician assistant, or nurse
  832  practitioner and other information from the primary caregiver as
  833  may be required by the facility before or at the time of
  834  admission to receive respite care. The medical information must
  835  include a physician’s order for respite care and proof of a
  836  physical examination by a licensed physician, physician
  837  assistant, or nurse practitioner. The physician’s order and
  838  physical examination may be used to provide intermittent respite
  839  care for up to 12 months after the date the order is written.
  840         6. The facility must assume the duties of the primary
  841  caregiver. To ensure continuity of care and services, the
  842  resident is entitled to retain his or her personal physician and
  843  must have access to medically necessary services such as
  844  physical therapy, occupational therapy, or speech therapy, as
  845  needed. The facility must arrange for transportation to these
  846  services if necessary. Respite care must be provided in
  847  accordance with this part and rules adopted by the agency.
  848  However, the agency shall, by rule, adopt modified requirements
  849  for resident assessment, resident care plans, resident
  850  contracts, physician orders, and other provisions, as
  851  appropriate, for short-term or temporary nursing home services.
  852         7. The agency shall allow for shared programming and staff
  853  in a facility which meets minimum standards and offers services
  854  pursuant to this paragraph, but, if the facility is cited for
  855  deficiencies in patient care, may require additional staff and
  856  programs appropriate to the needs of service recipients. A
  857  person who receives respite care may not be counted as a
  858  resident of the facility for purposes of the facility’s licensed
  859  capacity unless that person receives 24-hour respite care. A
  860  person receiving either respite care for 24 hours or longer or
  861  adult day services must be included when calculating minimum
  862  staffing for the facility. Any costs and revenues generated by a
  863  nursing home facility from nonresidential programs or services
  864  shall be excluded from the calculations of Medicaid per diems
  865  for nursing home institutional care reimbursement.
  866         (g) If the facility has a standard license or is a Gold
  867  Seal facility, exceeds the minimum required hours of licensed
  868  nursing and certified nursing assistant direct care per resident
  869  per day, and is part of a continuing care facility licensed
  870  under chapter 651 or a retirement community that offers other
  871  services pursuant to part III of this chapter or part I or part
  872  III of chapter 429 on a single campus, be allowed to share
  873  programming and staff. At the time of inspection and in the
  874  semiannual report required pursuant to paragraph (o), a
  875  continuing care facility or retirement community that uses this
  876  option must demonstrate through staffing records that minimum
  877  staffing requirements for the facility were met. Licensed nurses
  878  and certified nursing assistants who work in the nursing home
  879  facility may be used to provide services elsewhere on campus if
  880  the facility exceeds the minimum number of direct care hours
  881  required per resident per day and the total number of residents
  882  receiving direct care services from a licensed nurse or a
  883  certified nursing assistant does not cause the facility to
  884  violate the staffing ratios required under s. 400.23(3)(a).
  885  Compliance with the minimum staffing ratios shall be based on
  886  total number of residents receiving direct care services,
  887  regardless of where they reside on campus. If the facility
  888  receives a conditional license, it may not share staff until the
  889  conditional license status ends. This paragraph does not
  890  restrict the agency’s authority under federal or state law to
  891  require additional staff if a facility is cited for deficiencies
  892  in care which are caused by an insufficient number of certified
  893  nursing assistants or licensed nurses. The agency may adopt
  894  rules for the documentation necessary to determine compliance
  895  with this provision.
  896         (h) Maintain the facility premises and equipment and
  897  conduct its operations in a safe and sanitary manner.
  898         (i) If the licensee furnishes food service, provide a
  899  wholesome and nourishing diet sufficient to meet generally
  900  accepted standards of proper nutrition for its residents and
  901  provide such therapeutic diets as may be prescribed by attending
  902  physicians. In making rules to implement this paragraph, the
  903  agency shall be guided by standards recommended by nationally
  904  recognized professional groups and associations with knowledge
  905  of dietetics.
  906         (j) Keep full records of resident admissions and
  907  discharges; medical and general health status, including medical
  908  records, personal and social history, and identity and address
  909  of next of kin or other persons who may have responsibility for
  910  the affairs of the residents; and individual resident care plans
  911  including, but not limited to, prescribed services, service
  912  frequency and duration, and service goals. The records shall be
  913  open to inspection by the agency. The facility must maintain
  914  clinical records on each resident in accordance with accepted
  915  professional standards and practices that are complete,
  916  accurately documented, readily accessible, and systematically
  917  organized.
  918         (k) Keep such fiscal records of its operations and
  919  conditions as may be necessary to provide information pursuant
  920  to this part.
  921         (l) Furnish copies of personnel records for employees
  922  affiliated with such facility, to any other facility licensed by
  923  this state requesting this information pursuant to this part.
  924  Such information contained in the records may include, but is
  925  not limited to, disciplinary matters and any reason for
  926  termination. Any facility releasing such records pursuant to
  927  this part shall be considered to be acting in good faith and may
  928  not be held liable for information contained in such records,
  929  absent a showing that the facility maliciously falsified such
  930  records.
  931         (m) Publicly display a poster provided by the agency
  932  containing the names, addresses, and telephone numbers for the
  933  state’s abuse hotline, the State Long-Term Care Ombudsman, the
  934  Agency for Health Care Administration consumer hotline, the
  935  Advocacy Center for Persons with Disabilities, the Florida
  936  Statewide Advocacy Council, and the Medicaid Fraud Control Unit,
  937  with a clear description of the assistance to be expected from
  938  each.
  939         (n) Submit to the agency the information specified in s.
  940  400.071(1)(b) for a management company within 30 days after the
  941  effective date of the management agreement.
  942         (n)(o)1. Submit semiannually to the agency, or more
  943  frequently if requested by the agency, information regarding
  944  facility staff-to-resident ratios, staff turnover, and staff
  945  stability, including information regarding certified nursing
  946  assistants, licensed nurses, the director of nursing, and the
  947  facility administrator. For purposes of this reporting:
  948         a. Staff-to-resident ratios must be reported in the
  949  categories specified in s. 400.23(3)(a) and applicable rules.
  950  The ratio must be reported as an average for the most recent
  951  calendar quarter.
  952         b. Staff turnover must be reported for the most recent 12
  953  month period ending on the last workday of the most recent
  954  calendar quarter prior to the date the information is submitted.
  955  The turnover rate must be computed quarterly, with the annual
  956  rate being the cumulative sum of the quarterly rates. The
  957  turnover rate is the total number of terminations or separations
  958  experienced during the quarter, excluding any employee
  959  terminated during a probationary period of 3 months or less,
  960  divided by the total number of staff employed at the end of the
  961  period for which the rate is computed, and expressed as a
  962  percentage.
  963         c. The formula for determining staff stability is the total
  964  number of employees that have been employed for more than 12
  965  months, divided by the total number of employees employed at the
  966  end of the most recent calendar quarter, and expressed as a
  967  percentage.
  968         d. A nursing facility that has failed to comply with state
  969  minimum-staffing requirements for 2 consecutive days is
  970  prohibited from accepting new admissions until the facility has
  971  achieved the minimum-staffing requirements for a period of 6
  972  consecutive days. For the purposes of this sub-subparagraph, any
  973  person who was a resident of the facility and was absent from
  974  the facility for the purpose of receiving medical care at a
  975  separate location or was on a leave of absence is not considered
  976  a new admission. Failure to impose such an admissions moratorium
  977  is subject to a $1,000 fine constitutes a class II deficiency.
  978         2.e. A nursing facility which does not have a conditional
  979  license may be cited for failure to comply with the standards in
  980  s. 400.23(3)(a)1.b. and c. only if it has failed to meet those
  981  standards on 2 consecutive days or if it has failed to meet at
  982  least 97 percent of those standards on any one day.
  983         3.f. A facility which has a conditional license must be in
  984  compliance with the standards in s. 400.23(3)(a) at all times.
  985         2. This paragraph does not limit the agency’s ability to
  986  impose a deficiency or take other actions if a facility does not
  987  have enough staff to meet the residents’ needs.
  988         (o)(p) Notify a licensed physician when a resident exhibits
  989  signs of dementia or cognitive impairment or has a change of
  990  condition in order to rule out the presence of an underlying
  991  physiological condition that may be contributing to such
  992  dementia or impairment. The notification must occur within 30
  993  days after the acknowledgment of such signs by facility staff.
  994  If an underlying condition is determined to exist, the facility
  995  shall arrange, with the appropriate health care provider, the
  996  necessary care and services to treat the condition.
  997         (p)(q) If the facility implements a dining and hospitality
  998  attendant program, ensure that the program is developed and
  999  implemented under the supervision of the facility director of
 1000  nursing. A licensed nurse, licensed speech or occupational
 1001  therapist, or a registered dietitian must conduct training of
 1002  dining and hospitality attendants. A person employed by a
 1003  facility as a dining and hospitality attendant must perform
 1004  tasks under the direct supervision of a licensed nurse.
 1005         (r) Report to the agency any filing for bankruptcy
 1006  protection by the facility or its parent corporation,
 1007  divestiture or spin-off of its assets, or corporate
 1008  reorganization within 30 days after the completion of such
 1009  activity.
 1010         (q)(s) Maintain general and professional liability
 1011  insurance coverage that is in force at all times. In lieu of
 1012  general and professional liability insurance coverage, a state
 1013  designated teaching nursing home and its affiliated assisted
 1014  living facilities created under s. 430.80 may demonstrate proof
 1015  of financial responsibility as provided in s. 430.80(3)(g).
 1016         (r)(t) Maintain in the medical record for each resident a
 1017  daily chart of certified nursing assistant services provided to
 1018  the resident. The certified nursing assistant who is caring for
 1019  the resident must complete this record by the end of his or her
 1020  shift. This record must indicate assistance with activities of
 1021  daily living, assistance with eating, and assistance with
 1022  drinking, and must record each offering of nutrition and
 1023  hydration for those residents whose plan of care or assessment
 1024  indicates a risk for malnutrition or dehydration.
 1025         (s)(u) Before November 30 of each year, subject to the
 1026  availability of an adequate supply of the necessary vaccine,
 1027  provide for immunizations against influenza viruses to all its
 1028  consenting residents in accordance with the recommendations of
 1029  the United States Centers for Disease Control and Prevention,
 1030  subject to exemptions for medical contraindications and
 1031  religious or personal beliefs. Subject to these exemptions, any
 1032  consenting person who becomes a resident of the facility after
 1033  November 30 but before March 31 of the following year must be
 1034  immunized within 5 working days after becoming a resident.
 1035  Immunization shall not be provided to any resident who provides
 1036  documentation that he or she has been immunized as required by
 1037  this paragraph. This paragraph does not prohibit a resident from
 1038  receiving the immunization from his or her personal physician if
 1039  he or she so chooses. A resident who chooses to receive the
 1040  immunization from his or her personal physician shall provide
 1041  proof of immunization to the facility. The agency may adopt and
 1042  enforce any rules necessary to comply with or implement this
 1043  paragraph.
 1044         (t)(v) Assess all residents for eligibility for
 1045  pneumococcal polysaccharide vaccination (PPV) and vaccinate
 1046  residents when indicated within 60 days after the effective date
 1047  of this act in accordance with the recommendations of the United
 1048  States Centers for Disease Control and Prevention, subject to
 1049  exemptions for medical contraindications and religious or
 1050  personal beliefs. Residents admitted after the effective date of
 1051  this act shall be assessed within 5 working days of admission
 1052  and, when indicated, vaccinated within 60 days in accordance
 1053  with the recommendations of the United States Centers for
 1054  Disease Control and Prevention, subject to exemptions for
 1055  medical contraindications and religious or personal beliefs.
 1056  Immunization shall not be provided to any resident who provides
 1057  documentation that he or she has been immunized as required by
 1058  this paragraph. This paragraph does not prohibit a resident from
 1059  receiving the immunization from his or her personal physician if
 1060  he or she so chooses. A resident who chooses to receive the
 1061  immunization from his or her personal physician shall provide
 1062  proof of immunization to the facility. The agency may adopt and
 1063  enforce any rules necessary to comply with or implement this
 1064  paragraph.
 1065         (u)(w) Annually encourage and promote to its employees the
 1066  benefits associated with immunizations against influenza viruses
 1067  in accordance with the recommendations of the United States
 1068  Centers for Disease Control and Prevention. The agency may adopt
 1069  and enforce any rules necessary to comply with or implement this
 1070  paragraph.
 1071  
 1072  This subsection does not limit the agency’s ability to impose a
 1073  deficiency or take other actions if a facility does not have
 1074  enough staff to meet the residents’ needs.
 1075         (2) Facilities that have been awarded a Gold Seal under the
 1076  program established in s. 400.235 may develop a plan to provide
 1077  certified nursing assistant training as prescribed by federal
 1078  regulations and state rules and may apply to the agency for
 1079  approval of their program.
 1080         (3) A facility may charge a reasonable fee for the copying
 1081  of resident records. The fee may not exceed $1 per page for the
 1082  first 25 pages and 25 cents per page for each page in excess of
 1083  25 pages.
 1084         Section 32. Subsection (3) of section 400.142, Florida
 1085  Statutes, is amended to read:
 1086         400.142 Emergency medication kits; orders not to
 1087  resuscitate.—
 1088         (3) Facility staff may withhold or withdraw cardiopulmonary
 1089  resuscitation if presented with an order not to resuscitate
 1090  executed pursuant to s. 401.45. The agency shall adopt rules
 1091  providing for the implementation of such orders. Facility staff
 1092  and facilities shall not be subject to criminal prosecution or
 1093  civil liability, nor be considered to have engaged in negligent
 1094  or unprofessional conduct, for withholding or withdrawing
 1095  cardiopulmonary resuscitation pursuant to such an order and
 1096  rules adopted by the agency. The absence of an order not to
 1097  resuscitate executed pursuant to s. 401.45 does not preclude a
 1098  physician from withholding or withdrawing cardiopulmonary
 1099  resuscitation as otherwise permitted by law.
 1100         Section 33. Sections 400.0234, 400.145, and 429.294,
 1101  Florida Statutes, are repealed.
 1102         Section 34. Subsection (9) and subsections (11) through
 1103  (15) of section 400.147, Florida Statutes, are renumbered as
 1104  subsections (8) through (13), respectively, and present
 1105  subsections (7), (8), and (10) of that section are amended to
 1106  read:
 1107         400.147 Internal risk management and quality assurance
 1108  program.—
 1109         (7) The facility shall initiate an investigation and shall
 1110  notify the agency within 1 business day after the risk manager
 1111  or his or her designee has received a report pursuant to
 1112  paragraph (1)(d). Each facility shall complete the investigation
 1113  and submit a report to the agency within 15 calendar days after
 1114  an incident is determined to be an adverse incident. The
 1115  notification must be made in writing and be provided
 1116  electronically, by facsimile device or overnight mail delivery.
 1117  The agency shall develop a form for reporting this information
 1118  and the notification must include the name of the risk manager
 1119  of the facility, information regarding the identity of the
 1120  affected resident, the type of adverse incident, the initiation
 1121  of an investigation by the facility, and whether the events
 1122  causing or resulting in the adverse incident represent a
 1123  potential risk to any other resident. The notification is
 1124  confidential as provided by law and is not discoverable or
 1125  admissible in any civil or administrative action, except in
 1126  disciplinary proceedings by the agency or the appropriate
 1127  regulatory board. The agency may investigate, as it deems
 1128  appropriate, any such incident and prescribe measures that must
 1129  or may be taken in response to the incident. The agency shall
 1130  review each report incident and determine whether it potentially
 1131  involved conduct by the health care professional who is subject
 1132  to disciplinary action, in which case the provisions of s.
 1133  456.073 shall apply.
 1134         (8)(a) Each facility shall complete the investigation and
 1135  submit an adverse incident report to the agency for each adverse
 1136  incident within 15 calendar days after its occurrence. If, after
 1137  a complete investigation, the risk manager determines that the
 1138  incident was not an adverse incident as defined in subsection
 1139  (5), the facility shall include this information in the report.
 1140  The agency shall develop a form for reporting this information.
 1141         (b) The information reported to the agency pursuant to
 1142  paragraph (a) which relates to persons licensed under chapter
 1143  458, chapter 459, chapter 461, or chapter 466 shall be reviewed
 1144  by the agency. The agency shall determine whether any of the
 1145  incidents potentially involved conduct by a health care
 1146  professional who is subject to disciplinary action, in which
 1147  case the provisions of s. 456.073 shall apply.
 1148         (c) The report submitted to the agency must also contain
 1149  the name of the risk manager of the facility.
 1150         (d) The adverse incident report is confidential as provided
 1151  by law and is not discoverable or admissible in any civil or
 1152  administrative action, except in disciplinary proceedings by the
 1153  agency or the appropriate regulatory board.
 1154         (10) By the 10th of each month, each facility subject to
 1155  this section shall report any notice received pursuant to s.
 1156  400.0233(2) and each initial complaint that was filed with the
 1157  clerk of the court and served on the facility during the
 1158  previous month by a resident or a resident’s family member,
 1159  guardian, conservator, or personal legal representative. The
 1160  report must include the name of the resident, the resident’s
 1161  date of birth and social security number, the Medicaid
 1162  identification number for Medicaid-eligible persons, the date or
 1163  dates of the incident leading to the claim or dates of
 1164  residency, if applicable, and the type of injury or violation of
 1165  rights alleged to have occurred. Each facility shall also submit
 1166  a copy of the notices received pursuant to s. 400.0233(2) and
 1167  complaints filed with the clerk of the court. This report is
 1168  confidential as provided by law and is not discoverable or
 1169  admissible in any civil or administrative action, except in such
 1170  actions brought by the agency to enforce the provisions of this
 1171  part.
 1172         Section 35. Section 400.148, Florida Statutes, is repealed.
 1173         Section 36. Paragraph (e) of subsection (2) of section
 1174  400.179, Florida Statutes, is amended to read:
 1175         400.179 Liability for Medicaid underpayments and
 1176  overpayments.—
 1177         (2) Because any transfer of a nursing facility may expose
 1178  the fact that Medicaid may have underpaid or overpaid the
 1179  transferor, and because in most instances, any such underpayment
 1180  or overpayment can only be determined following a formal field
 1181  audit, the liabilities for any such underpayments or
 1182  overpayments shall be as follows:
 1183         (e) For the 2009-2010 fiscal year only, the provisions of
 1184  paragraph (d) shall not apply. This paragraph expires July 1,
 1185  2010.
 1186         Section 37. Subsection (3) of section 400.19, Florida
 1187  Statutes, is amended to read:
 1188         400.19 Right of entry and inspection.—
 1189         (3) The agency shall every 15 months conduct at least one
 1190  unannounced inspection to determine compliance by the licensee
 1191  with statutes, and with rules promulgated under the provisions
 1192  of those statutes, governing minimum standards of construction,
 1193  quality and adequacy of care, and rights of residents. The
 1194  survey shall be conducted every 6 months for the next 2-year
 1195  period if the facility has been cited for a class I deficiency,
 1196  has been cited for two or more class II deficiencies arising
 1197  from separate surveys or investigations within a 60-day period,
 1198  or has had three or more substantiated complaints within a 6
 1199  month period, each resulting in at least one class I or class II
 1200  deficiency. In addition to any other fees or fines in this part,
 1201  the agency shall assess a fine for each facility that is subject
 1202  to the 6-month survey cycle. The fine for the 2-year period
 1203  shall be $6,000, one-half to be paid at the completion of each
 1204  survey. The agency may adjust this fine by the change in the
 1205  Consumer Price Index, based on the 12 months immediately
 1206  preceding the increase, to cover the cost of the additional
 1207  surveys. The agency shall verify through subsequent inspection
 1208  that any deficiency identified during inspection is corrected.
 1209  However, the agency may verify the correction of a class III or
 1210  class IV deficiency unrelated to resident rights or resident
 1211  care without reinspecting the facility if adequate written
 1212  documentation has been received from the facility, which
 1213  provides assurance that the deficiency has been corrected. The
 1214  giving or causing to be given of advance notice of such
 1215  unannounced inspections by an employee of the agency to any
 1216  unauthorized person shall constitute cause for suspension of not
 1217  fewer than 5 working days according to the provisions of chapter
 1218  110.
 1219         Section 38. Subsection (5) of section 400.23, Florida
 1220  Statutes, is amended to read:
 1221         400.23 Rules; evaluation and deficiencies; licensure
 1222  status.—
 1223         (5)(a) The agency, in collaboration with the Division of
 1224  Children’s Medical Services Network of the Department of Health,
 1225  must, no later than December 31, 1993, adopt rules for minimum
 1226  standards of care for persons under 21 years of age who reside
 1227  in nursing home facilities. The rules must include a methodology
 1228  for reviewing a nursing home facility under ss. 408.031-408.045
 1229  which serves only persons under 21 years of age. A facility may
 1230  be exempt from these standards for specific persons between 18
 1231  and 21 years of age, if the person’s physician agrees that
 1232  minimum standards of care based on age are not necessary.
 1233         (b) The agency, in collaboration with the Division of
 1234  Children’s Medical Services Network, shall adopt rules for
 1235  minimum staffing requirements for nursing home facilities that
 1236  serve persons under 21 years of age, which shall apply in lieu
 1237  of the standards contained in subsection (3).
 1238         1. For persons under 21 years of age who require skilled
 1239  care, the requirements shall include a minimum combined average
 1240  of licensed nurses, respiratory therapists, respiratory care
 1241  practitioners, and certified nursing assistants of 3.9 hours of
 1242  direct care per resident per day for each nursing home facility.
 1243         2. For persons under 21 years of age who are fragile, the
 1244  requirements shall include a minimum combined average of
 1245  licensed nurses, respiratory therapists, respiratory care
 1246  practitioners, and certified nursing assistants of 5 hours of
 1247  direct care per resident per day for each nursing home facility.
 1248         Section 39. Subsection (1) of section 400.275, Florida
 1249  Statutes, is amended to read:
 1250         400.275 Agency duties.—
 1251         (1) The agency shall ensure that each newly hired nursing
 1252  home surveyor, as a part of basic training, is assigned full
 1253  time to a licensed nursing home for at least 2 days within a 7
 1254  day period to observe facility operations outside of the survey
 1255  process before the surveyor begins survey responsibilities. Such
 1256  observations may not be the sole basis of a deficiency citation
 1257  against the facility. The agency may not assign an individual to
 1258  be a member of a survey team for purposes of a survey,
 1259  evaluation, or consultation visit at a nursing home facility in
 1260  which the surveyor was an employee within the preceding 2 5
 1261  years.
 1262         Section 40. Subsection (27) of section 400.462, Florida
 1263  Statutes, is amended to read:
 1264         400.462 Definitions.—As used in this part, the term:
 1265         (27) “Remuneration” means any payment or other benefit made
 1266  directly or indirectly, overtly or covertly, in cash or in kind.
 1267  However, when the term is used in any provision of law relating
 1268  to a health care provider, such term does not mean an item with
 1269  an individual value of up to $15, including, but not limited to,
 1270  plaques, certificates, trophies, or novelties that are intended
 1271  solely for presentation or are customarily given away solely for
 1272  promotional, recognition, or advertising purposes.
 1273         Section 41. Subsection (2) of section 400.484, Florida
 1274  Statutes, is amended to read:
 1275         400.484 Right of inspection; violations deficiencies;
 1276  fines.—
 1277         (2) The agency shall impose fines for various classes of
 1278  violations deficiencies in accordance with the following
 1279  schedule:
 1280         (a) Class I violations are defined in s. 408.813. A class I
 1281  deficiency is any act, omission, or practice that results in a
 1282  patient’s death, disablement, or permanent injury, or places a
 1283  patient at imminent risk of death, disablement, or permanent
 1284  injury. Upon finding a class I violation deficiency, the agency
 1285  shall impose an administrative fine in the amount of $15,000 for
 1286  each occurrence and each day that the violation deficiency
 1287  exists.
 1288         (b) Class II violations are defined in s. 408.813. A class
 1289  II deficiency is any act, omission, or practice that has a
 1290  direct adverse effect on the health, safety, or security of a
 1291  patient. Upon finding a class II violation deficiency, the
 1292  agency shall impose an administrative fine in the amount of
 1293  $5,000 for each occurrence and each day that the violation
 1294  deficiency exists.
 1295         (c) Class III violations are defined in s. 408.813. A class
 1296  III deficiency is any act, omission, or practice that has an
 1297  indirect, adverse effect on the health, safety, or security of a
 1298  patient. Upon finding an uncorrected or repeated class III
 1299  violation deficiency, the agency shall impose an administrative
 1300  fine not to exceed $1,000 for each occurrence and each day that
 1301  the uncorrected or repeated violation deficiency exists.
 1302         (d) Class IV violations are defined in s. 408.813. A class
 1303  IV deficiency is any act, omission, or practice related to
 1304  required reports, forms, or documents which does not have the
 1305  potential of negatively affecting patients. These violations are
 1306  of a type that the agency determines do not threaten the health,
 1307  safety, or security of patients. Upon finding an uncorrected or
 1308  repeated class IV violation deficiency, the agency shall impose
 1309  an administrative fine not to exceed $500 for each occurrence
 1310  and each day that the uncorrected or repeated violation
 1311  deficiency exists.
 1312         Section 42. Subsections (16) and (17) of section 400.506,
 1313  Florida Statutes, are renumbered as subsections (17) and (18),
 1314  respectively, paragraph (a) of subsection (15) is amended, and a
 1315  new subsection (16) is added to that section, to read:
 1316         400.506 Licensure of nurse registries; requirements;
 1317  penalties.—
 1318         (15)(a) The agency may deny, suspend, or revoke the license
 1319  of a nurse registry and shall impose a fine of $5,000 against a
 1320  nurse registry that:
 1321         1. Provides services to residents in an assisted living
 1322  facility for which the nurse registry does not receive fair
 1323  market value remuneration.
 1324         2. Provides staffing to an assisted living facility for
 1325  which the nurse registry does not receive fair market value
 1326  remuneration.
 1327         3. Fails to provide the agency, upon request, with copies
 1328  of all contracts with assisted living facilities which were
 1329  executed within the last 5 years.
 1330         4. Gives remuneration to a case manager, discharge planner,
 1331  facility-based staff member, or third-party vendor who is
 1332  involved in the discharge planning process of a facility
 1333  licensed under chapter 395 or this chapter and from whom the
 1334  nurse registry receives referrals. A nurse registry is exempt
 1335  from this subparagraph if it does not bill the Florida Medicaid
 1336  program or the Medicare program or share a controlling interest
 1337  with any entity licensed, registered, or certified under part II
 1338  of chapter 408 that bills the Florida Medicaid program or the
 1339  Medicare program.
 1340         5. Gives remuneration to a physician, a member of the
 1341  physician’s office staff, or an immediate family member of the
 1342  physician, and the nurse registry received a patient referral in
 1343  the last 12 months from that physician or the physician’s office
 1344  staff. A nurse registry is exempt from this subparagraph if it
 1345  does not bill the Florida Medicaid program or the Medicare
 1346  program or share a controlling interest with any entity
 1347  licensed, registered, or certified under part II of chapter 408
 1348  that bills the Florida Medicaid program or the Medicare program.
 1349         (16) An administrator may manage only one nurse registry,
 1350  except that an administrator may manage up to five registries if
 1351  all five registries have identical controlling interests as
 1352  defined in s. 408.803 and are located within one agency
 1353  geographic service area or within an immediately contiguous
 1354  county. An administrator shall designate, in writing, for each
 1355  licensed entity, a qualified alternate administrator to serve
 1356  during the administrator’s absence.
 1357         Section 43. Subsection (1) of section 400.509, Florida
 1358  Statutes, is amended to read:
 1359         400.509 Registration of particular service providers exempt
 1360  from licensure; certificate of registration; regulation of
 1361  registrants.—
 1362         (1) Any organization that provides companion services or
 1363  homemaker services and does not provide a home health service to
 1364  a person is exempt from licensure under this part. However, any
 1365  organization that provides companion services or homemaker
 1366  services must register with the agency. An organization under
 1367  contract with the Agency for Persons with Disabilities that
 1368  provides companion services only for persons with a
 1369  developmental disability, as defined in s. 393.063, is exempt
 1370  from registration.
 1371         Section 44. Paragraph (i) of subsection (1) and subsection
 1372  (4) of section 400.606, Florida Statutes, are amended to read:
 1373         400.606 License; application; renewal; conditional license
 1374  or permit; certificate of need.—
 1375         (1) In addition to the requirements of part II of chapter
 1376  408, the initial application and change of ownership application
 1377  must be accompanied by a plan for the delivery of home,
 1378  residential, and homelike inpatient hospice services to
 1379  terminally ill persons and their families. Such plan must
 1380  contain, but need not be limited to:
 1381         (i) The projected annual operating cost of the hospice.
 1382  If the applicant is an existing licensed health care provider,
 1383  the application must be accompanied by a copy of the most recent
 1384  profit-loss statement and, if applicable, the most recent
 1385  licensure inspection report.
 1386         (4) A freestanding hospice facility that is primarily
 1387  engaged in providing inpatient and related services and that is
 1388  not otherwise licensed as a health care facility shall be
 1389  required to obtain a certificate of need. However, a
 1390  freestanding hospice facility with six or fewer beds shall not
 1391  be required to comply with institutional standards such as, but
 1392  not limited to, standards requiring sprinkler systems, emergency
 1393  electrical systems, or special lavatory devices.
 1394         Section 45. Subsection (2) of section 400.607, Florida
 1395  Statutes, is amended to read:
 1396         400.607 Denial, suspension, revocation of license;
 1397  emergency actions; imposition of administrative fine; grounds.—
 1398         (2) A violation of this part, part II of chapter 408, or
 1399  applicable rules Any of the following actions by a licensed
 1400  hospice or any of its employees shall be grounds for
 1401  administrative action by the agency against a hospice.:
 1402         (a) A violation of the provisions of this part, part II of
 1403  chapter 408, or applicable rules.
 1404         (b) An intentional or negligent act materially affecting
 1405  the health or safety of a patient.
 1406         Section 46. Section 400.915, Florida Statutes, is amended
 1407  to read:
 1408         400.915 Construction and renovation; requirements.—The
 1409  requirements for the construction or renovation of a PPEC center
 1410  shall comply with:
 1411         (1) The provisions of chapter 553, which pertain to
 1412  building construction standards, including plumbing, electrical
 1413  code, glass, manufactured buildings, accessibility for the
 1414  physically disabled;
 1415         (2) The provisions of s. 633.022 and applicable rules
 1416  pertaining to physical minimum standards for nonresidential
 1417  child care physical facilities in rule 10M-12.003, Florida
 1418  Administrative Code, Child Care Standards; and
 1419         (3) The standards or rules adopted pursuant to this part
 1420  and part II of chapter 408.
 1421         Section 47. Subsection (1) of section 400.925, Florida
 1422  Statutes, is amended to read:
 1423         400.925 Definitions.—As used in this part, the term:
 1424         (1) “Accrediting organizations” means the Joint Commission
 1425  on Accreditation of Healthcare Organizations or other national
 1426  accreditation agencies whose standards for accreditation are
 1427  comparable to those required by this part for licensure.
 1428         Section 48. Subsection (2) of section 400.931, Florida
 1429  Statutes, is amended to read:
 1430         400.931 Application for license; fee; provisional license;
 1431  temporary permit.—
 1432         (2) An applicant for initial licensure, change of
 1433  ownership, or renewal to operate a licensed home medical
 1434  equipment provider at a location outside the state must submit
 1435  documentation of accreditation or an application for
 1436  accreditation from an accrediting organization that is
 1437  recognized by the agency. An applicant that has applied for
 1438  accreditation must provide proof of accreditation that is not
 1439  conditional or provisional within 120 days after the date the
 1440  agency receives the application for licensure or the application
 1441  shall be withdrawn from further consideration. Such
 1442  accreditation must be maintained by the home medical equipment
 1443  provider to maintain licensure. As an alternative to submitting
 1444  proof of financial ability to operate as required in s.
 1445  408.810(8), the applicant may submit a $50,000 surety bond to
 1446  the agency.
 1447         Section 49. Subsection (2) of section 400.932, Florida
 1448  Statutes, is amended to read:
 1449         400.932 Administrative penalties.—
 1450         (2) A violation of this part, part II of chapter 408, or
 1451  applicable rules Any of the following actions by an employee of
 1452  a home medical equipment provider shall be are grounds for
 1453  administrative action or penalties by the agency.:
 1454         (a) Violation of this part, part II of chapter 408, or
 1455  applicable rules.
 1456         (b) An intentional, reckless, or negligent act that
 1457  materially affects the health or safety of a patient.
 1458         Section 50. Subsection (3) of section 400.967, Florida
 1459  Statutes, is amended to read:
 1460         400.967 Rules and classification of violations
 1461  deficiencies.—
 1462         (3) The agency shall adopt rules to provide that, when the
 1463  criteria established under this part and part II of chapter 408
 1464  are not met, such violations deficiencies shall be classified
 1465  according to the nature of the violation deficiency. The agency
 1466  shall indicate the classification on the face of the notice of
 1467  deficiencies as follows:
 1468         (a) Class I violations deficiencies are defined in s.
 1469  408.813 those which the agency determines present an imminent
 1470  danger to the residents or guests of the facility or a
 1471  substantial probability that death or serious physical harm
 1472  would result therefrom. The condition or practice constituting a
 1473  class I violation must be abated or eliminated immediately,
 1474  unless a fixed period of time, as determined by the agency, is
 1475  required for correction. A class I violation deficiency is
 1476  subject to a civil penalty in an amount not less than $5,000 and
 1477  not exceeding $10,000 for each violation deficiency. A fine may
 1478  be levied notwithstanding the correction of the violation
 1479  deficiency.
 1480         (b) Class II violations deficiencies are defined in s.
 1481  408.813 those which the agency determines have a direct or
 1482  immediate relationship to the health, safety, or security of the
 1483  facility residents, other than class I deficiencies. A class II
 1484  violation deficiency is subject to a civil penalty in an amount
 1485  not less than $1,000 and not exceeding $5,000 for each violation
 1486  deficiency. A citation for a class II violation deficiency shall
 1487  specify the time within which the violation deficiency must be
 1488  corrected. If a class II violation deficiency is corrected
 1489  within the time specified, no civil penalty shall be imposed,
 1490  unless it is a repeated offense.
 1491         (c) Class III violations deficiencies are defined in s.
 1492  408.813 those which the agency determines to have an indirect or
 1493  potential relationship to the health, safety, or security of the
 1494  facility residents, other than class I or class II deficiencies.
 1495  A class III violation deficiency is subject to a civil penalty
 1496  of not less than $500 and not exceeding $1,000 for each
 1497  deficiency. A citation for a class III violation deficiency
 1498  shall specify the time within which the violation deficiency
 1499  must be corrected. If a class III violation deficiency is
 1500  corrected within the time specified, no civil penalty shall be
 1501  imposed, unless it is a repeated offense.
 1502         (d) Class IV violations are defined in s. 408.813. Upon
 1503  finding an uncorrected or repeated class IV violation, the
 1504  agency shall impose an administrative fine not to exceed $500
 1505  for each occurrence and each day that the uncorrected or
 1506  repeated violation exists.
 1507         Section 51. Subsections (4) and (7) of section 400.9905,
 1508  Florida Statutes, are amended to read:
 1509         400.9905 Definitions.—
 1510         (4) “Clinic” means an entity at which health care services
 1511  are provided to individuals and which tenders charges for
 1512  reimbursement for such services, including a mobile clinic and a
 1513  portable health service or equipment provider. For purposes of
 1514  this part, the term does not include and the licensure
 1515  requirements of this part do not apply to:
 1516         (a) Entities licensed or registered by the state under
 1517  chapter 395; or entities licensed or registered by the state and
 1518  providing only health care services within the scope of services
 1519  authorized under their respective licenses granted under ss.
 1520  383.30-383.335, chapter 390, chapter 394, chapter 397, this
 1521  chapter except part X, chapter 429, chapter 463, chapter 465,
 1522  chapter 466, chapter 478, part I of chapter 483, chapter 484, or
 1523  chapter 651; end-stage renal disease providers authorized under
 1524  42 C.F.R. part 405, subpart U; or providers certified under 42
 1525  C.F.R. part 485, subpart B or subpart H; or any entity that
 1526  provides neonatal or pediatric hospital-based health care
 1527  services or other health care services by licensed practitioners
 1528  solely within a hospital licensed under chapter 395.
 1529         (b) Entities that own, directly or indirectly, entities
 1530  licensed or registered by the state pursuant to chapter 395; or
 1531  entities that own, directly or indirectly, entities licensed or
 1532  registered by the state and providing only health care services
 1533  within the scope of services authorized pursuant to their
 1534  respective licenses granted under ss. 383.30-383.335, chapter
 1535  390, chapter 394, chapter 397, this chapter except part X,
 1536  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1537  part I of chapter 483, chapter 484, chapter 651; end-stage renal
 1538  disease providers authorized under 42 C.F.R. part 405, subpart
 1539  U; or providers certified under 42 C.F.R. part 485, subpart B or
 1540  subpart H; or any entity that provides neonatal or pediatric
 1541  hospital-based health care services by licensed practitioners
 1542  solely within a hospital licensed under chapter 395.
 1543         (c) Entities that are owned, directly or indirectly, by an
 1544  entity licensed or registered by the state pursuant to chapter
 1545  395; or entities that are owned, directly or indirectly, by an
 1546  entity licensed or registered by the state and providing only
 1547  health care services within the scope of services authorized
 1548  pursuant to their respective licenses granted under ss. 383.30
 1549  383.335, chapter 390, chapter 394, chapter 397, this chapter
 1550  except part X, chapter 429, chapter 463, chapter 465, chapter
 1551  466, chapter 478, part I of chapter 483, chapter 484, or chapter
 1552  651; end-stage renal disease providers authorized under 42
 1553  C.F.R. part 405, subpart U; or providers certified under 42
 1554  C.F.R. part 485, subpart B or subpart H; or any entity that
 1555  provides neonatal or pediatric hospital-based health care
 1556  services by licensed practitioners solely within a hospital
 1557  under chapter 395.
 1558         (d) Entities that are under common ownership, directly or
 1559  indirectly, with an entity licensed or registered by the state
 1560  pursuant to chapter 395; or entities that are under common
 1561  ownership, directly or indirectly, with an entity licensed or
 1562  registered by the state and providing only health care services
 1563  within the scope of services authorized pursuant to their
 1564  respective licenses granted under ss. 383.30-383.335, chapter
 1565  390, chapter 394, chapter 397, this chapter except part X,
 1566  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1567  part I of chapter 483, chapter 484, or chapter 651; end-stage
 1568  renal disease providers authorized under 42 C.F.R. part 405,
 1569  subpart U; or providers certified under 42 C.F.R. part 485,
 1570  subpart B or subpart H; or any entity that provides neonatal or
 1571  pediatric hospital-based health care services by licensed
 1572  practitioners solely within a hospital licensed under chapter
 1573  395.
 1574         (e) An entity that is exempt from federal taxation under 26
 1575  U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
 1576  under 26 U.S.C. s. 409 that has a board of trustees not less
 1577  than two-thirds of which are Florida-licensed health care
 1578  practitioners and provides only physical therapy services under
 1579  physician orders, any community college or university clinic,
 1580  and any entity owned or operated by the federal or state
 1581  government, including agencies, subdivisions, or municipalities
 1582  thereof.
 1583         (f) A sole proprietorship, group practice, partnership, or
 1584  corporation that provides health care services by physicians
 1585  covered by s. 627.419, that is directly supervised by one or
 1586  more of such physicians, and that is wholly owned by one or more
 1587  of those physicians or by a physician and the spouse, parent,
 1588  child, or sibling of that physician.
 1589         (g) A sole proprietorship, group practice, partnership, or
 1590  corporation that provides health care services by licensed
 1591  health care practitioners under chapter 457, chapter 458,
 1592  chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
 1593  chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
 1594  chapter 490, chapter 491, or part I, part III, part X, part
 1595  XIII, or part XIV of chapter 468, or s. 464.012, which are
 1596  wholly owned by one or more licensed health care practitioners,
 1597  or the licensed health care practitioners set forth in this
 1598  paragraph and the spouse, parent, child, or sibling of a
 1599  licensed health care practitioner, so long as one of the owners
 1600  who is a licensed health care practitioner is supervising the
 1601  business activities and is legally responsible for the entity’s
 1602  compliance with all federal and state laws. However, a health
 1603  care practitioner may not supervise services beyond the scope of
 1604  the practitioner’s license, except that, for the purposes of
 1605  this part, a clinic owned by a licensee in s. 456.053(3)(b) that
 1606  provides only services authorized pursuant to s. 456.053(3)(b)
 1607  may be supervised by a licensee specified in s. 456.053(3)(b).
 1608         (h) Clinical facilities affiliated with an accredited
 1609  medical school at which training is provided for medical
 1610  students, residents, or fellows.
 1611         (i) Entities that provide only oncology or radiation
 1612  therapy services by physicians licensed under chapter 458 or
 1613  chapter 459 or entities that provide oncology or radiation
 1614  therapy services by physicians licensed under chapter 458 or
 1615  chapter 459 which are owned by a corporation whose shares are
 1616  publicly traded on a recognized stock exchange.
 1617         (j) Clinical facilities affiliated with a college of
 1618  chiropractic accredited by the Council on Chiropractic Education
 1619  at which training is provided for chiropractic students.
 1620         (k) Entities that provide licensed practitioners to staff
 1621  emergency departments or to deliver anesthesia services in
 1622  facilities licensed under chapter 395 and that derive at least
 1623  90 percent of their gross annual revenues from the provision of
 1624  such services. Entities claiming an exemption from licensure
 1625  under this paragraph must provide documentation demonstrating
 1626  compliance.
 1627         (l) Orthotic, or prosthetic, pediatric cardiology, or
 1628  perinatology clinical facilities that are a publicly traded
 1629  corporation or that are wholly owned, directly or indirectly, by
 1630  a publicly traded corporation. As used in this paragraph, a
 1631  publicly traded corporation is a corporation that issues
 1632  securities traded on an exchange registered with the United
 1633  States Securities and Exchange Commission as a national
 1634  securities exchange.
 1635         (m) Entities that are owned by a corporation that has $250
 1636  million or more in total annual sales of health care services
 1637  provided by licensed health care practitioners if one or more of
 1638  the owners of the entity is a health care practitioner who is
 1639  licensed in this state, is responsible for supervising the
 1640  business activities of the entity, and is legally responsible
 1641  for the entity’s compliance with state law for purposes of this
 1642  section.
 1643         (n) Entities that are owned or controlled, directly or
 1644  indirectly, by a publicly traded entity with $100 million or
 1645  more, in the aggregate, in total annual revenues derived from
 1646  providing health care services by licensed health care
 1647  practitioners that are employed or contracted by an entity
 1648  described in this paragraph.
 1649         (o) Entities that employ 50 or more health care
 1650  practitioners licensed under chapter 458 or chapter 459 when the
 1651  billing for medical services is under a single tax
 1652  identification number. The application for exemption under this
 1653  paragraph shall contain information that includes the name,
 1654  residence address, business address, and phone number of the
 1655  entity that owns the practice; a complete list of the names and
 1656  contact information of all the officers and directors of the
 1657  entity; the name, residence address, business address, and
 1658  medical license number of each licensed Florida health care
 1659  practitioner employed by the entity; the corporate tax
 1660  identification number of the entity seeking an exemption; a
 1661  listing of health care services to be provided by the entity at
 1662  the health care clinics owned or operated by the entity and a
 1663  certified statement prepared by an independent certified public
 1664  accountant which states that the entity and the health care
 1665  clinics owned or operated by the entity have not received
 1666  payment for health care services under personal injury
 1667  protection insurance coverage for the previous year. If the
 1668  agency determines that an entity that is exempt under this
 1669  paragraph has received payments for medical services under
 1670  personal injury protection insurance coverage the agency may
 1671  deny or revoke the exemption from licensure under this
 1672  paragraph.
 1673         (7) “Portable health service or equipment provider” means
 1674  an entity that contracts with or employs persons to provide
 1675  portable health services or equipment to multiple locations
 1676  performing treatment or diagnostic testing of individuals, that
 1677  bills third-party payors for those services, and that otherwise
 1678  meets the definition of a clinic in subsection (4).
 1679         Section 52. Paragraph (b) of subsection (1) and paragraph
 1680  (c) of subsection (4) of section 400.991, Florida Statutes, are
 1681  amended to read:
 1682         400.991 License requirements; background screenings;
 1683  prohibitions.—
 1684         (1)
 1685         (b) Each mobile clinic must obtain a separate health care
 1686  clinic license and must provide to the agency, at least
 1687  quarterly, its projected street location to enable the agency to
 1688  locate and inspect such clinic. A portable health service or
 1689  equipment provider must obtain a health care clinic license for
 1690  a single administrative office and is not required to submit
 1691  quarterly projected street locations.
 1692         (4) In addition to the requirements of part II of chapter
 1693  408, the applicant must file with the application satisfactory
 1694  proof that the clinic is in compliance with this part and
 1695  applicable rules, including:
 1696         (c) Proof of financial ability to operate as required under
 1697  ss. s. 408.810(8) and 408.8065. As an alternative to submitting
 1698  proof of financial ability to operate as required under s.
 1699  408.810(8), the applicant may file a surety bond of at least
 1700  $500,000 which guarantees that the clinic will act in full
 1701  conformity with all legal requirements for operating a clinic,
 1702  payable to the agency. The agency may adopt rules to specify
 1703  related requirements for such surety bond.
 1704         Section 53. Paragraph (g) of subsection (1) and paragraph
 1705  (a) of subsection (7) of section 400.9935, Florida Statutes, are
 1706  amended to read:
 1707         400.9935 Clinic responsibilities.—
 1708         (1) Each clinic shall appoint a medical director or clinic
 1709  director who shall agree in writing to accept legal
 1710  responsibility for the following activities on behalf of the
 1711  clinic. The medical director or the clinic director shall:
 1712         (g) Conduct systematic reviews of clinic billings to ensure
 1713  that the billings are not fraudulent or unlawful. Upon discovery
 1714  of an unlawful charge, the medical director or clinic director
 1715  shall take immediate corrective action. If the clinic performs
 1716  only the technical component of magnetic resonance imaging,
 1717  static radiographs, computed tomography, or positron emission
 1718  tomography, and provides the professional interpretation of such
 1719  services, in a fixed facility that is accredited by the Joint
 1720  Commission on Accreditation of Healthcare Organizations or the
 1721  Accreditation Association for Ambulatory Health Care, and the
 1722  American College of Radiology; and if, in the preceding quarter,
 1723  the percentage of scans performed by that clinic which was
 1724  billed to all personal injury protection insurance carriers was
 1725  less than 15 percent, the chief financial officer of the clinic
 1726  may, in a written acknowledgment provided to the agency, assume
 1727  the responsibility for the conduct of the systematic reviews of
 1728  clinic billings to ensure that the billings are not fraudulent
 1729  or unlawful.
 1730         (7)(a) Each clinic engaged in magnetic resonance imaging
 1731  services must be accredited by the Joint Commission on
 1732  Accreditation of Healthcare Organizations, the American College
 1733  of Radiology, or the Accreditation Association for Ambulatory
 1734  Health Care, within 1 year after licensure. A clinic that is
 1735  accredited by the American College of Radiology or is within the
 1736  original 1-year period after licensure and replaces its core
 1737  magnetic resonance imaging equipment shall be given 1 year after
 1738  the date on which the equipment is replaced to attain
 1739  accreditation. However, a clinic may request a single, 6-month
 1740  extension if it provides evidence to the agency establishing
 1741  that, for good cause shown, such clinic cannot be accredited
 1742  within 1 year after licensure, and that such accreditation will
 1743  be completed within the 6-month extension. After obtaining
 1744  accreditation as required by this subsection, each such clinic
 1745  must maintain accreditation as a condition of renewal of its
 1746  license. A clinic that files a change of ownership application
 1747  must comply with the original accreditation timeframe
 1748  requirements of the transferor. The agency shall deny a change
 1749  of ownership application if the clinic is not in compliance with
 1750  the accreditation requirements. When a clinic adds, replaces, or
 1751  modifies magnetic resonance imaging equipment and the
 1752  accreditation agency requires new accreditation, the clinic must
 1753  be accredited within 1 year after the date of the addition,
 1754  replacement, or modification but may request a single, 6-month
 1755  extension if the clinic provides evidence of good cause to the
 1756  agency.
 1757         Section 54. Paragraph (a) of subsection (2) of section
 1758  408.033, Florida Statutes, is amended to read:
 1759         408.033 Local and state health planning.—
 1760         (2) FUNDING.—
 1761         (a) The Legislature intends that the cost of local health
 1762  councils be borne by assessments on selected health care
 1763  facilities subject to facility licensure by the Agency for
 1764  Health Care Administration, including abortion clinics, assisted
 1765  living facilities, ambulatory surgical centers, birthing
 1766  centers, clinical laboratories except community nonprofit blood
 1767  banks and clinical laboratories operated by practitioners for
 1768  exclusive use regulated under s. 483.035, home health agencies,
 1769  hospices, hospitals, intermediate care facilities for the
 1770  developmentally disabled, nursing homes, health care clinics,
 1771  and multiphasic testing centers and by assessments on
 1772  organizations subject to certification by the agency pursuant to
 1773  chapter 641, part III, including health maintenance
 1774  organizations and prepaid health clinics. Fees assessed may be
 1775  collected prospectively at the time of licensure renewal and
 1776  prorated for the licensure period.
 1777         Section 55. Subsection (2) of section 408.034, Florida
 1778  Statutes, is amended to read:
 1779         408.034 Duties and responsibilities of agency; rules.—
 1780         (2) In the exercise of its authority to issue licenses to
 1781  health care facilities and health service providers, as provided
 1782  under chapters 393 and 395 and parts II, and IV, and VIII of
 1783  chapter 400, the agency may not issue a license to any health
 1784  care facility or health service provider that fails to receive a
 1785  certificate of need or an exemption for the licensed facility or
 1786  service.
 1787         Section 56. Paragraph (d) of subsection (1) and paragraph
 1788  (m) of subsection (3) of section 408.036, Florida Statutes, are
 1789  amended to read:
 1790         408.036 Projects subject to review; exemptions.—
 1791         (1) APPLICABILITY.—Unless exempt under subsection (3), all
 1792  health-care-related projects, as described in paragraphs (a)
 1793  (g), are subject to review and must file an application for a
 1794  certificate of need with the agency. The agency is exclusively
 1795  responsible for determining whether a health-care-related
 1796  project is subject to review under ss. 408.031-408.045.
 1797         (d) The establishment of a hospice or hospice inpatient
 1798  facility, except as provided in s. 408.043.
 1799         (3) EXEMPTIONS.—Upon request, the following projects are
 1800  subject to exemption from the provisions of subsection (1):
 1801         (m)1. For the provision of adult open-heart services in a
 1802  hospital located within the boundaries of a health service
 1803  planning district, as defined in s. 408.032(5), which has
 1804  experienced an annual net out-migration of at least 600 open
 1805  heart-surgery cases for 3 consecutive years according to the
 1806  most recent data reported to the agency, and the district’s
 1807  population per licensed and operational open-heart programs
 1808  exceeds the state average of population per licensed and
 1809  operational open-heart programs by at least 25 percent. All
 1810  hospitals within a health service planning district which meet
 1811  the criteria reference in sub-subparagraphs 2.a.-h. shall be
 1812  eligible for this exemption on July 1, 2004, and shall receive
 1813  the exemption upon filing for it and subject to the following:
 1814         a. A hospital that has received a notice of intent to grant
 1815  a certificate of need or a final order of the agency granting a
 1816  certificate of need for the establishment of an open-heart
 1817  surgery program is entitled to receive a letter of exemption for
 1818  the establishment of an adult open-heart-surgery program upon
 1819  filing a request for exemption and complying with the criteria
 1820  enumerated in sub-subparagraphs 2.a.-h., and is entitled to
 1821  immediately commence operation of the program.
 1822         b. An otherwise eligible hospital that has not received a
 1823  notice of intent to grant a certificate of need or a final order
 1824  of the agency granting a certificate of need for the
 1825  establishment of an open-heart-surgery program is entitled to
 1826  immediately receive a letter of exemption for the establishment
 1827  of an adult open-heart-surgery program upon filing a request for
 1828  exemption and complying with the criteria enumerated in sub
 1829  subparagraphs 2.a.-h., but is not entitled to commence operation
 1830  of its program until December 31, 2006.
 1831         2. A hospital shall be exempt from the certificate-of-need
 1832  review for the establishment of an open-heart-surgery program
 1833  when the application for exemption submitted under this
 1834  paragraph complies with the following criteria:
 1835         a. The applicant must certify that it will meet and
 1836  continuously maintain the minimum licensure requirements adopted
 1837  by the agency governing adult open-heart programs, including the
 1838  most current guidelines of the American College of Cardiology
 1839  and American Heart Association Guidelines for Adult Open Heart
 1840  Programs.
 1841         b. The applicant must certify that it will maintain
 1842  sufficient appropriate equipment and health personnel to ensure
 1843  quality and safety.
 1844         c. The applicant must certify that it will maintain
 1845  appropriate times of operation and protocols to ensure
 1846  availability and appropriate referrals in the event of
 1847  emergencies.
 1848         d. The applicant can demonstrate that it has discharged at
 1849  least 300 inpatients with a principal diagnosis of ischemic
 1850  heart disease for the most recent 12-month period as reported to
 1851  the agency.
 1852         e. The applicant is a general acute care hospital that is
 1853  in operation for 3 years or more.
 1854         f. The applicant is performing more than 300 diagnostic
 1855  cardiac catheterization procedures per year, combined inpatient
 1856  and outpatient.
 1857         g. The applicant’s payor mix at a minimum reflects the
 1858  community average for Medicaid, charity care, and self-pay
 1859  patients or the applicant must certify that it will provide a
 1860  minimum of 5 percent of Medicaid, charity care, and self-pay to
 1861  open-heart-surgery patients.
 1862         h. If the applicant fails to meet the established criteria
 1863  for open-heart programs or fails to reach 300 surgeries per year
 1864  by the end of its third year of operation, it must show cause
 1865  why its exemption should not be revoked.
 1866         3. By December 31, 2004, and annually thereafter, the
 1867  agency shall submit a report to the Legislature providing
 1868  information concerning the number of requests for exemption it
 1869  has received under this paragraph during the calendar year and
 1870  the number of exemptions it has granted or denied during the
 1871  calendar year.
 1872         Section 57. Paragraph (c) of subsection (1) of section
 1873  408.037, Florida Statutes, is amended to read:
 1874         408.037 Application content.—
 1875         (1) Except as provided in subsection (2) for a general
 1876  hospital, an application for a certificate of need must contain:
 1877         (c) An audited financial statement of the applicant or the
 1878  applicant’s parent corporation if audited financial statements
 1879  of the applicant do not exist. In an application submitted by an
 1880  existing health care facility, health maintenance organization,
 1881  or hospice, financial condition documentation must include, but
 1882  need not be limited to, a balance sheet and a profit-and-loss
 1883  statement of the 2 previous fiscal years’ operation.
 1884         Section 58. Subsection (2) of section 408.043, Florida
 1885  Statutes, is amended to read:
 1886         408.043 Special provisions.—
 1887         (2) HOSPICES.—When an application is made for a certificate
 1888  of need to establish or to expand a hospice, the need for such
 1889  hospice shall be determined on the basis of the need for and
 1890  availability of hospice services in the community. The formula
 1891  on which the certificate of need is based shall discourage
 1892  regional monopolies and promote competition. The inpatient
 1893  hospice care component of a hospice which is a freestanding
 1894  facility, or a part of a facility, which is primarily engaged in
 1895  providing inpatient care and related services and is not
 1896  licensed as a health care facility shall also be required to
 1897  obtain a certificate of need. Provision of hospice care by any
 1898  current provider of health care is a significant change in
 1899  service and therefore requires a certificate of need for such
 1900  services.
 1901         Section 59. Paragraph (k) of subsection (3) of section
 1902  408.05, Florida Statutes, is amended to read:
 1903         408.05 Florida Center for Health Information and Policy
 1904  Analysis.—
 1905         (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to
 1906  produce comparable and uniform health information and statistics
 1907  for the development of policy recommendations, the agency shall
 1908  perform the following functions:
 1909         (k) Develop, in conjunction with the State Consumer Health
 1910  Information and Policy Advisory Council, and implement a long
 1911  range plan for making available health care quality measures and
 1912  financial data that will allow consumers to compare health care
 1913  services. The health care quality measures and financial data
 1914  the agency must make available shall include, but is not limited
 1915  to, pharmaceuticals, physicians, health care facilities, and
 1916  health plans and managed care entities. The agency shall update
 1917  the plan and report on the status of its implementation
 1918  annually. The agency shall also make the plan and status report
 1919  available to the public on its Internet website. As part of the
 1920  plan, the agency shall identify the process and timeframes for
 1921  implementation, any barriers to implementation, and
 1922  recommendations of changes in the law that may be enacted by the
 1923  Legislature to eliminate the barriers. As preliminary elements
 1924  of the plan, the agency shall:
 1925         1. Make available patient-safety indicators, inpatient
 1926  quality indicators, and performance outcome and patient charge
 1927  data collected from health care facilities pursuant to s.
 1928  408.061(1)(a) and (2). The terms “patient-safety indicators” and
 1929  “inpatient quality indicators” shall be as defined by the
 1930  Centers for Medicare and Medicaid Services, the National Quality
 1931  Forum, the Joint Commission on Accreditation of Healthcare
 1932  Organizations, the Agency for Healthcare Research and Quality,
 1933  the Centers for Disease Control and Prevention, or a similar
 1934  national entity that establishes standards to measure the
 1935  performance of health care providers, or by other states. The
 1936  agency shall determine which conditions, procedures, health care
 1937  quality measures, and patient charge data to disclose based upon
 1938  input from the council. When determining which conditions and
 1939  procedures are to be disclosed, the council and the agency shall
 1940  consider variation in costs, variation in outcomes, and
 1941  magnitude of variations and other relevant information. When
 1942  determining which health care quality measures to disclose, the
 1943  agency:
 1944         a. Shall consider such factors as volume of cases; average
 1945  patient charges; average length of stay; complication rates;
 1946  mortality rates; and infection rates, among others, which shall
 1947  be adjusted for case mix and severity, if applicable.
 1948         b. May consider such additional measures that are adopted
 1949  by the Centers for Medicare and Medicaid Studies, National
 1950  Quality Forum, the Joint Commission on Accreditation of
 1951  Healthcare Organizations, the Agency for Healthcare Research and
 1952  Quality, Centers for Disease Control and Prevention, or a
 1953  similar national entity that establishes standards to measure
 1954  the performance of health care providers, or by other states.
 1955  
 1956  When determining which patient charge data to disclose, the
 1957  agency shall include such measures as the average of
 1958  undiscounted charges on frequently performed procedures and
 1959  preventive diagnostic procedures, the range of procedure charges
 1960  from highest to lowest, average net revenue per adjusted patient
 1961  day, average cost per adjusted patient day, and average cost per
 1962  admission, among others.
 1963         2. Make available performance measures, benefit design, and
 1964  premium cost data from health plans licensed pursuant to chapter
 1965  627 or chapter 641. The agency shall determine which health care
 1966  quality measures and member and subscriber cost data to
 1967  disclose, based upon input from the council. When determining
 1968  which data to disclose, the agency shall consider information
 1969  that may be required by either individual or group purchasers to
 1970  assess the value of the product, which may include membership
 1971  satisfaction, quality of care, current enrollment or membership,
 1972  coverage areas, accreditation status, premium costs, plan costs,
 1973  premium increases, range of benefits, copayments and
 1974  deductibles, accuracy and speed of claims payment, credentials
 1975  of physicians, number of providers, names of network providers,
 1976  and hospitals in the network. Health plans shall make available
 1977  to the agency any such data or information that is not currently
 1978  reported to the agency or the office.
 1979         3. Determine the method and format for public disclosure of
 1980  data reported pursuant to this paragraph. The agency shall make
 1981  its determination based upon input from the State Consumer
 1982  Health Information and Policy Advisory Council. At a minimum,
 1983  the data shall be made available on the agency’s Internet
 1984  website in a manner that allows consumers to conduct an
 1985  interactive search that allows them to view and compare the
 1986  information for specific providers. The website must include
 1987  such additional information as is determined necessary to ensure
 1988  that the website enhances informed decisionmaking among
 1989  consumers and health care purchasers, which shall include, at a
 1990  minimum, appropriate guidance on how to use the data and an
 1991  explanation of why the data may vary from provider to provider.
 1992         4. Publish on its website undiscounted charges for no fewer
 1993  than 150 of the most commonly performed adult and pediatric
 1994  procedures, including outpatient, inpatient, diagnostic, and
 1995  preventative procedures.
 1996         Section 60. Paragraph (a) of subsection (1) of section
 1997  408.061, Florida Statutes, is amended to read:
 1998         408.061 Data collection; uniform systems of financial
 1999  reporting; information relating to physician charges;
 2000  confidential information; immunity.—
 2001         (1) The agency shall require the submission by health care
 2002  facilities, health care providers, and health insurers of data
 2003  necessary to carry out the agency’s duties. Specifications for
 2004  data to be collected under this section shall be developed by
 2005  the agency with the assistance of technical advisory panels
 2006  including representatives of affected entities, consumers,
 2007  purchasers, and such other interested parties as may be
 2008  determined by the agency.
 2009         (a) Data submitted by health care facilities, including the
 2010  facilities as defined in chapter 395, shall include, but are not
 2011  limited to: case-mix data, patient admission and discharge data,
 2012  hospital emergency department data which shall include the
 2013  number of patients treated in the emergency department of a
 2014  licensed hospital reported by patient acuity level, data on
 2015  hospital-acquired infections as specified by rule, data on
 2016  complications as specified by rule, data on readmissions as
 2017  specified by rule, with patient and provider-specific
 2018  identifiers included, actual charge data by diagnostic groups,
 2019  financial data, accounting data, operating expenses, expenses
 2020  incurred for rendering services to patients who cannot or do not
 2021  pay, interest charges, depreciation expenses based on the
 2022  expected useful life of the property and equipment involved, and
 2023  demographic data. The agency shall adopt nationally recognized
 2024  risk adjustment methodologies or software consistent with the
 2025  standards of the Agency for Healthcare Research and Quality and
 2026  as selected by the agency for all data submitted as required by
 2027  this section. Data may be obtained from documents such as, but
 2028  not limited to: leases, contracts, debt instruments, itemized
 2029  patient bills, medical record abstracts, and related diagnostic
 2030  information. Reported data elements shall be reported
 2031  electronically and in accordance with rule 59E-7.012, Florida
 2032  Administrative Code. Data submitted shall be certified by the
 2033  chief executive officer or an appropriate and duly authorized
 2034  representative or employee of the licensed facility that the
 2035  information submitted is true and accurate.
 2036         Section 61. Subsection (43) of section 408.07, Florida
 2037  Statutes, is amended to read:
 2038         408.07 Definitions.—As used in this chapter, with the
 2039  exception of ss. 408.031-408.045, the term:
 2040         (43) “Rural hospital” means an acute care hospital licensed
 2041  under chapter 395, having 100 or fewer licensed beds and an
 2042  emergency room, and which is:
 2043         (a) The sole provider within a county with a population
 2044  density of no greater than 100 persons per square mile;
 2045         (b) An acute care hospital, in a county with a population
 2046  density of no greater than 100 persons per square mile, which is
 2047  at least 30 minutes of travel time, on normally traveled roads
 2048  under normal traffic conditions, from another acute care
 2049  hospital within the same county;
 2050         (c) A hospital supported by a tax district or subdistrict
 2051  whose boundaries encompass a population of 100 persons or fewer
 2052  per square mile;
 2053         (d) A hospital with a service area that has a population of
 2054  100 persons or fewer per square mile. As used in this paragraph,
 2055  the term “service area” means the fewest number of zip codes
 2056  that account for 75 percent of the hospital’s discharges for the
 2057  most recent 5-year period, based on information available from
 2058  the hospital inpatient discharge database in the Florida Center
 2059  for Health Information and Policy Analysis at the Agency for
 2060  Health Care Administration; or
 2061         (e) A critical access hospital.
 2062  
 2063  Population densities used in this subsection must be based upon
 2064  the most recently completed United States census. A hospital
 2065  that received funds under s. 409.9116 for a quarter beginning no
 2066  later than July 1, 2002, is deemed to have been and shall
 2067  continue to be a rural hospital from that date through June 30,
 2068  2015, if the hospital continues to have 100 or fewer licensed
 2069  beds and an emergency room, or meets the criteria of s.
 2070  395.602(2)(e)4. An acute care hospital that has not previously
 2071  been designated as a rural hospital and that meets the criteria
 2072  of this subsection shall be granted such designation upon
 2073  application, including supporting documentation, to the Agency
 2074  for Health Care Administration.
 2075         Section 62. Section 408.10, Florida Statutes, is amended to
 2076  read:
 2077         408.10 Consumer complaints.—The agency shall:
 2078         (1) publish and make available to the public a toll-free
 2079  telephone number for the purpose of handling consumer complaints
 2080  and shall serve as a liaison between consumer entities and other
 2081  private entities and governmental entities for the disposition
 2082  of problems identified by consumers of health care.
 2083         (2) Be empowered to investigate consumer complaints
 2084  relating to problems with health care facilities’ billing
 2085  practices and issue reports to be made public in any cases where
 2086  the agency determines the health care facility has engaged in
 2087  billing practices which are unreasonable and unfair to the
 2088  consumer.
 2089         Section 63. Subsections (12) through (30) of section
 2090  408.802, Florida Statutes, are renumbered as subsections (11)
 2091  through (29), respectively, and present subsection (11) of that
 2092  section is amended to read:
 2093         408.802 Applicability.—The provisions of this part apply to
 2094  the provision of services that require licensure as defined in
 2095  this part and to the following entities licensed, registered, or
 2096  certified by the agency, as described in chapters 112, 383, 390,
 2097  394, 395, 400, 429, 440, 483, and 765:
 2098         (11) Private review agents, as provided under part I of
 2099  chapter 395.
 2100         Section 64. Subsection (3) is added to section 408.804,
 2101  Florida Statutes, to read:
 2102         408.804 License required; display.—
 2103         (3) Any person who knowingly alters, defaces, or falsifies
 2104  a license certificate issued by the agency, or causes or
 2105  procures any person to commit such an offense, commits a
 2106  misdemeanor of the second degree, punishable as provided in s.
 2107  775.082 or s 775.083. Any licensee or provider who displays an
 2108  altered, defaced, or falsified license certificate is subject to
 2109  the penalties set forth in s. 408.815 and an administrative fine
 2110  of $1,000 for each day of illegal display.
 2111         Section 65. Paragraph (d) of subsection (2) of section
 2112  408.806, Florida Statutes, is amended, and paragraph (e) is
 2113  added to that subsection, to read:
 2114         408.806 License application process.—
 2115         (2)
 2116         (d) The agency shall notify the licensee by mail or
 2117  electronically at least 90 days before the expiration of a
 2118  license that a renewal license is necessary to continue
 2119  operation. The licensee’s failure to timely file submit a
 2120  renewal application and license application fee with the agency
 2121  shall result in a $50 per day late fee charged to the licensee
 2122  by the agency; however, the aggregate amount of the late fee may
 2123  not exceed 50 percent of the licensure fee or $500, whichever is
 2124  less. The agency shall provide a courtesy notice to the licensee
 2125  by United States mail, electronically, or by any other manner at
 2126  its address of record or mailing address, if provided, at least
 2127  90 days prior to the expiration of a license informing the
 2128  licensee of the expiration of the license. If the licensee does
 2129  not receive the courtesy notice, the licensee continues to be
 2130  legally obligated to timely file the renewal application and
 2131  license application fee with the agency and is not excused from
 2132  the payment of a late fee. If an application is received after
 2133  the required filing date and exhibits a hand-canceled postmark
 2134  obtained from a United States post office dated on or before the
 2135  required filing date, no fine will be levied.
 2136         (e) The applicant must pay the late fee before a late
 2137  application is considered complete and failure to pay the late
 2138  fee is considered an omission from the application for licensure
 2139  pursuant to paragraph (3)(b).
 2140         Section 66. Paragraph (b) of subsection (1) of section
 2141  408.8065, Florida Statutes, is amended to read:
 2142         408.8065 Additional licensure requirements for home health
 2143  agencies, home medical equipment providers, and health care
 2144  clinics.—
 2145         (1) An applicant for initial licensure, or initial
 2146  licensure due to a change of ownership, as a home health agency,
 2147  home medical equipment provider, or health care clinic shall:
 2148         (b) Submit projected pro forma financial statements,
 2149  including a balance sheet, income and expense statement, and a
 2150  statement of cash flows for the first 2 years of operation which
 2151  provide evidence that the applicant has sufficient assets,
 2152  credit, and projected revenues to cover liabilities and
 2153  expenses.
 2154  
 2155  All documents required under this subsection must be prepared in
 2156  accordance with generally accepted accounting principles and may
 2157  be in a compilation form. The financial statements must be
 2158  signed by a certified public accountant.
 2159         Section 67. Subsections (5) through (8) of section 408.809,
 2160  Florida Statutes are renumbered as subsections (6) through (9),
 2161  respectively, and subsection (4) of that section is amended to
 2162  read:
 2163         408.809 Background screening; prohibited offenses.—
 2164         (4) In addition to the offenses listed in s. 435.04, all
 2165  persons required to undergo background screening pursuant to
 2166  this part or authorizing statutes must not have an arrest
 2167  awaiting final disposition for, must not have been found guilty
 2168  of, regardless of adjudication, or entered a plea of nolo
 2169  contendere or guilty to, and must not have been adjudicated
 2170  delinquent and the record not have been sealed or expunged for
 2171  any of the following offenses or any similar offense of another
 2172  jurisdiction:
 2173         (a) Any authorizing statutes, if the offense was a felony.
 2174         (b) This chapter, if the offense was a felony.
 2175         (c) Section 409.920, relating to Medicaid provider fraud.
 2176         (d) Section 409.9201, relating to Medicaid fraud.
 2177         (e) Section 741.28, relating to domestic violence.
 2178         (f) Section 817.034, relating to fraudulent acts through
 2179  mail, wire, radio, electromagnetic, photoelectronic, or
 2180  photooptical systems.
 2181         (g) Section 817.234, relating to false and fraudulent
 2182  insurance claims.
 2183         (h) Section 817.505, relating to patient brokering.
 2184         (i) Section 817.568, relating to criminal use of personal
 2185  identification information.
 2186         (j) Section 817.60, relating to obtaining a credit card
 2187  through fraudulent means.
 2188         (k) Section 817.61, relating to fraudulent use of credit
 2189  cards, if the offense was a felony.
 2190         (l) Section 831.01, relating to forgery.
 2191         (m) Section 831.02, relating to uttering forged
 2192  instruments.
 2193         (n) Section 831.07, relating to forging bank bills, checks,
 2194  drafts, or promissory notes.
 2195         (o) Section 831.09, relating to uttering forged bank bills,
 2196  checks, drafts, or promissory notes.
 2197         (p) Section 831.30, relating to fraud in obtaining
 2198  medicinal drugs.
 2199         (q) Section 831.31, relating to the sale, manufacture,
 2200  delivery, or possession with the intent to sell, manufacture, or
 2201  deliver any counterfeit controlled substance, if the offense was
 2202  a felony.
 2203         (5) A person who serves as a controlling interest of, is
 2204  employed by, or contracts with a licensee on July 31, 2010, who
 2205  has been screened and qualified according to standards specified
 2206  in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015,
 2207  in accordance with the schedule provided in paragraphs (a)-(c).
 2208  The agency may adopt rules to establish a schedule to stagger
 2209  the implementation of the required rescreening over the 5-year
 2210  period, beginning July 31, 2010, through July 31, 2015. If, upon
 2211  rescreening, such person has a disqualifying offense that was
 2212  not a disqualifying offense at the time of the last screening,
 2213  but is a current disqualifying offense and was committed before
 2214  the last screening, he or she may apply for an exemption from
 2215  the appropriate licensing agency and, if agreed to by the
 2216  employer, may continue to perform his or her duties until the
 2217  licensing agency renders a decision on the application for
 2218  exemption if the person is eligible to apply for an exemption
 2219  and the exemption request is received by the agency within 30
 2220  days after receipt of the rescreening results by the person. The
 2221  rescreening schedule shall be:
 2222         (a) Individuals whose last screening was conducted before
 2223  December 31, 2003, must be rescreened by July 31, 2013.
 2224         (b) Individuals whose last screening was conducted between
 2225  January 1, 2004, through December 31, 2007, must be rescreened
 2226  by July 31, 2014.
 2227         (c) Individuals whose last screening was conducted between
 2228  January 1, 2008, through July 31, 2010, must be rescreened by
 2229  July 31, 2015.
 2230         Section 68. Subsection (9) of section 408.810, Florida
 2231  Statutes, is amended to read:
 2232         408.810 Minimum licensure requirements.—In addition to the
 2233  licensure requirements specified in this part, authorizing
 2234  statutes, and applicable rules, each applicant and licensee must
 2235  comply with the requirements of this section in order to obtain
 2236  and maintain a license.
 2237         (9) A controlling interest may not withhold from the agency
 2238  any evidence of financial instability, including, but not
 2239  limited to, checks returned due to insufficient funds,
 2240  delinquent accounts, nonpayment of withholding taxes, unpaid
 2241  utility expenses, nonpayment for essential services, or adverse
 2242  court action concerning the financial viability of the provider
 2243  or any other provider licensed under this part that is under the
 2244  control of the controlling interest. A controlling interest
 2245  shall notify the agency within 10 days after a court action to
 2246  initiate bankruptcy, foreclosure, or eviction proceedings
 2247  concerning the provider in which the controlling interest is a
 2248  petitioner or defendant. Any person who violates this subsection
 2249  commits a misdemeanor of the second degree, punishable as
 2250  provided in s. 775.082 or s. 775.083. Each day of continuing
 2251  violation is a separate offense.
 2252         Section 69. Subsection (3) is added to section 408.813,
 2253  Florida Statutes, to read:
 2254         408.813 Administrative fines; violations.—As a penalty for
 2255  any violation of this part, authorizing statutes, or applicable
 2256  rules, the agency may impose an administrative fine.
 2257         (3) The agency may impose an administrative fine for a
 2258  violation that is not designated as a class I, class II, class
 2259  III, or class IV violation. Unless otherwise specified by law,
 2260  the amount of the fine shall not exceed $500 for each violation.
 2261  Unclassified violations may include:
 2262         (a) Violating any term or condition of a license.
 2263         (b) Violating any provision of this part, authorizing
 2264  statutes, or applicable rules.
 2265         (c) Exceeding licensed capacity.
 2266         (d) Providing services beyond the scope of the license.
 2267         (e) Violating a moratorium imposed pursuant to s. 408.814.
 2268         Section 70. Subsection (4) of section 408.815, Florida
 2269  Statutes, is amended, and subsections (5) and (6) are added to
 2270  that section, to read:
 2271         408.815 License or application denial; revocation.—
 2272         (4) Unless an applicant is determined by the agency to
 2273  satisfy the provisions of subsection (5) for the action in
 2274  question, the agency shall deny an application for a license or
 2275  license renewal based upon any of the following actions of an
 2276  applicant, a controlling interest of the applicant, or any
 2277  entity in which a controlling interest of the applicant was an
 2278  owner or officer when the following actions occurred In addition
 2279  to the grounds provided in authorizing statutes, the agency
 2280  shall deny an application for a license or license renewal if
 2281  the applicant or a person having a controlling interest in an
 2282  applicant has been:
 2283         (a) Conviction Convicted of, or enters a plea of guilty or
 2284  nolo contendere to, regardless of adjudication, a felony under
 2285  chapter 409, chapter 817, chapter 893, 21 U.S.C. ss. 801-970, or
 2286  42 U.S.C. ss. 1395-1396, Medicare fraud, Medicaid fraud, or
 2287  insurance fraud, unless the sentence and any subsequent period
 2288  of probation for such convictions or plea ended more than 15
 2289  years prior to the date of the application;
 2290         (b) Termination Terminated for cause from the Medicare
 2291  program or a state Florida Medicaid program pursuant to s.
 2292  409.913, unless the applicant has been in good standing with the
 2293  Medicare program or a state Florida Medicaid program for the
 2294  most recent 5 years and the termination occurred at least 20
 2295  years before the date of the application.; or
 2296         (c) Terminated for cause, pursuant to the appeals
 2297  procedures established by the state or Federal Government, from
 2298  the federal Medicare program or from any other state Medicaid
 2299  program, unless the applicant has been in good standing with a
 2300  state Medicaid program or the federal Medicare program for the
 2301  most recent 5 years and the termination occurred at least 20
 2302  years prior to the date of the application.
 2303         (5) For any application subject to denial under subsection
 2304  (4), the agency may consider mitigating circumstances, as
 2305  applicable, including, but not limited to:
 2306         (a) Completion or lawful release from confinement,
 2307  supervision, or sanction, including any terms of probation, and
 2308  full restitution;
 2309         (b) Execution of a compliance plan with the agency;
 2310         (c) Compliance with any integrity agreement or compliance
 2311  plan with any other government agency;
 2312         (d) Determination by the Medicare program or a state
 2313  Medicaid program that the controlling interest or entity in
 2314  which the controlling interest was an owner or officer is
 2315  currently allowed to participate in the Medicare program or a
 2316  state Medicaid program, either directly as a provider or
 2317  indirectly as an owner or officer of a provider entity;
 2318         (e) Continuation of licensure by the controlling interest
 2319  or entity in which the controlling interest was an owner or
 2320  officer, either directly as a licensee or indirectly as an owner
 2321  or officer of a licensed entity in the state where the action
 2322  occurred;
 2323         (f) Overall impact upon the public health, safety, or
 2324  welfare; or
 2325         (g) Determination that license denial is not commensurate
 2326  with the prior action taken by the Medicare program or a state
 2327  Medicaid program.
 2328  
 2329  After considering the circumstances set forth in this
 2330  subsection, the agency shall grant the license, with or without
 2331  conditions, grant a provisional license for a period of no more
 2332  than the licensure cycle, with or without conditions, or deny
 2333  the license.
 2334         (6) In order to ensure the health, safety, and welfare of
 2335  clients when a license has been denied, revoked, or is set to
 2336  terminate, the agency may extend the license expiration date for
 2337  a period of up to 30 days for the sole purpose of allowing the
 2338  safe and orderly discharge of clients. The agency may impose
 2339  conditions on the extension, including, but not limited to,
 2340  prohibiting or limiting admissions, expedited discharge
 2341  planning, required status reports, and mandatory monitoring by
 2342  the agency or third parties. When imposing these conditions, the
 2343  agency shall take into consideration the nature and number of
 2344  clients, the availability and location of acceptable alternative
 2345  placements, and the ability of the licensee to continue
 2346  providing care to the clients. The agency may terminate the
 2347  extension or modify the conditions at any time. This authority
 2348  is in addition to any other authority granted to the agency
 2349  under chapter 120, this part, and authorizing statutes but
 2350  creates no right or entitlement to an extension of a license
 2351  expiration date.
 2352         Section 71. Paragraph (c) of subsection (4) of section
 2353  409.212, Florida Statutes, is amended to read:
 2354         409.212 Optional supplementation.—
 2355         (4) In addition to the amount of optional supplementation
 2356  provided by the state, a person may receive additional
 2357  supplementation from third parties to contribute to his or her
 2358  cost of care. Additional supplementation may be provided under
 2359  the following conditions:
 2360         (c) The additional supplementation shall not exceed three
 2361  two times the provider rate recognized under the optional state
 2362  supplementation program.
 2363         Section 72. Subsection (1) of section 409.91196, Florida
 2364  Statutes, is amended to read:
 2365         409.91196 Supplemental rebate agreements; public records
 2366  and public meetings exemption.—
 2367         (1) The rebate amount, percent of rebate, manufacturer’s
 2368  pricing, and supplemental rebate, and other trade secrets as
 2369  defined in s. 688.002 that the agency has identified for use in
 2370  negotiations, held by the Agency for Health Care Administration
 2371  under s. 409.912(39)(a)8.7. are confidential and exempt from s.
 2372  119.07(1) and s. 24(a), Art. I of the State Constitution.
 2373         Section 73. Paragraph (b) of subsection (4), paragraph (a)
 2374  of subsection (39), and subsection (41) of section 409.912,
 2375  Florida Statutes, are amended to read:
 2376         409.912 Cost-effective purchasing of health care.—The
 2377  agency shall purchase goods and services for Medicaid recipients
 2378  in the most cost-effective manner consistent with the delivery
 2379  of quality medical care. To ensure that medical services are
 2380  effectively utilized, the agency may, in any case, require a
 2381  confirmation or second physician’s opinion of the correct
 2382  diagnosis for purposes of authorizing future services under the
 2383  Medicaid program. This section does not restrict access to
 2384  emergency services or poststabilization care services as defined
 2385  in 42 C.F.R. part 438.114. Such confirmation or second opinion
 2386  shall be rendered in a manner approved by the agency. The agency
 2387  shall maximize the use of prepaid per capita and prepaid
 2388  aggregate fixed-sum basis services when appropriate and other
 2389  alternative service delivery and reimbursement methodologies,
 2390  including competitive bidding pursuant to s. 287.057, designed
 2391  to facilitate the cost-effective purchase of a case-managed
 2392  continuum of care. The agency shall also require providers to
 2393  minimize the exposure of recipients to the need for acute
 2394  inpatient, custodial, and other institutional care and the
 2395  inappropriate or unnecessary use of high-cost services. The
 2396  agency shall contract with a vendor to monitor and evaluate the
 2397  clinical practice patterns of providers in order to identify
 2398  trends that are outside the normal practice patterns of a
 2399  provider’s professional peers or the national guidelines of a
 2400  provider’s professional association. The vendor must be able to
 2401  provide information and counseling to a provider whose practice
 2402  patterns are outside the norms, in consultation with the agency,
 2403  to improve patient care and reduce inappropriate utilization.
 2404  The agency may mandate prior authorization, drug therapy
 2405  management, or disease management participation for certain
 2406  populations of Medicaid beneficiaries, certain drug classes, or
 2407  particular drugs to prevent fraud, abuse, overuse, and possible
 2408  dangerous drug interactions. The Pharmaceutical and Therapeutics
 2409  Committee shall make recommendations to the agency on drugs for
 2410  which prior authorization is required. The agency shall inform
 2411  the Pharmaceutical and Therapeutics Committee of its decisions
 2412  regarding drugs subject to prior authorization. The agency is
 2413  authorized to limit the entities it contracts with or enrolls as
 2414  Medicaid providers by developing a provider network through
 2415  provider credentialing. The agency may competitively bid single
 2416  source-provider contracts if procurement of goods or services
 2417  results in demonstrated cost savings to the state without
 2418  limiting access to care. The agency may limit its network based
 2419  on the assessment of beneficiary access to care, provider
 2420  availability, provider quality standards, time and distance
 2421  standards for access to care, the cultural competence of the
 2422  provider network, demographic characteristics of Medicaid
 2423  beneficiaries, practice and provider-to-beneficiary standards,
 2424  appointment wait times, beneficiary use of services, provider
 2425  turnover, provider profiling, provider licensure history,
 2426  previous program integrity investigations and findings, peer
 2427  review, provider Medicaid policy and billing compliance records,
 2428  clinical and medical record audits, and other factors. Providers
 2429  shall not be entitled to enrollment in the Medicaid provider
 2430  network. The agency shall determine instances in which allowing
 2431  Medicaid beneficiaries to purchase durable medical equipment and
 2432  other goods is less expensive to the Medicaid program than long
 2433  term rental of the equipment or goods. The agency may establish
 2434  rules to facilitate purchases in lieu of long-term rentals in
 2435  order to protect against fraud and abuse in the Medicaid program
 2436  as defined in s. 409.913. The agency may seek federal waivers
 2437  necessary to administer these policies.
 2438         (4) The agency may contract with:
 2439         (b) An entity that is providing comprehensive behavioral
 2440  health care services to certain Medicaid recipients through a
 2441  capitated, prepaid arrangement pursuant to the federal waiver
 2442  provided for by s. 409.905(5). Such entity must be licensed
 2443  under chapter 624, chapter 636, or chapter 641, or authorized
 2444  under paragraph (c) or paragraph (d), and must possess the
 2445  clinical systems and operational competence to manage risk and
 2446  provide comprehensive behavioral health care to Medicaid
 2447  recipients. As used in this paragraph, the term “comprehensive
 2448  behavioral health care services” means covered mental health and
 2449  substance abuse treatment services that are available to
 2450  Medicaid recipients. The secretary of the Department of Children
 2451  and Family Services shall approve provisions of procurements
 2452  related to children in the department’s care or custody before
 2453  enrolling such children in a prepaid behavioral health plan. Any
 2454  contract awarded under this paragraph must be competitively
 2455  procured. In developing the behavioral health care prepaid plan
 2456  procurement document, the agency shall ensure that the
 2457  procurement document requires the contractor to develop and
 2458  implement a plan to ensure compliance with s. 394.4574 related
 2459  to services provided to residents of licensed assisted living
 2460  facilities that hold a limited mental health license. Except as
 2461  provided in subparagraph 8., and except in counties where the
 2462  Medicaid managed care pilot program is authorized pursuant to s.
 2463  409.91211, the agency shall seek federal approval to contract
 2464  with a single entity meeting these requirements to provide
 2465  comprehensive behavioral health care services to all Medicaid
 2466  recipients not enrolled in a Medicaid managed care plan
 2467  authorized under s. 409.91211, a provider service network
 2468  authorized under paragraph (d), or a Medicaid health maintenance
 2469  organization in an AHCA area. In an AHCA area where the Medicaid
 2470  managed care pilot program is authorized pursuant to s.
 2471  409.91211 in one or more counties, the agency may procure a
 2472  contract with a single entity to serve the remaining counties as
 2473  an AHCA area or the remaining counties may be included with an
 2474  adjacent AHCA area and are subject to this paragraph. Each
 2475  entity must offer a sufficient choice of providers in its
 2476  network to ensure recipient access to care and the opportunity
 2477  to select a provider with whom they are satisfied. The network
 2478  shall include all public mental health hospitals. To ensure
 2479  unimpaired access to behavioral health care services by Medicaid
 2480  recipients, all contracts issued pursuant to this paragraph must
 2481  require 80 percent of the capitation paid to the managed care
 2482  plan, including health maintenance organizations and capitated
 2483  provider service networks, to be expended for the provision of
 2484  behavioral health care services. If the managed care plan
 2485  expends less than 80 percent of the capitation paid for the
 2486  provision of behavioral health care services, the difference
 2487  shall be returned to the agency. The agency shall provide the
 2488  plan with a certification letter indicating the amount of
 2489  capitation paid during each calendar year for behavioral health
 2490  care services pursuant to this section. The agency may reimburse
 2491  for substance abuse treatment services on a fee-for-service
 2492  basis until the agency finds that adequate funds are available
 2493  for capitated, prepaid arrangements.
 2494         1. By January 1, 2001, the agency shall modify the
 2495  contracts with the entities providing comprehensive inpatient
 2496  and outpatient mental health care services to Medicaid
 2497  recipients in Hillsborough, Highlands, Hardee, Manatee, and Polk
 2498  Counties, to include substance abuse treatment services.
 2499         2. By July 1, 2003, the agency and the Department of
 2500  Children and Family Services shall execute a written agreement
 2501  that requires collaboration and joint development of all policy,
 2502  budgets, procurement documents, contracts, and monitoring plans
 2503  that have an impact on the state and Medicaid community mental
 2504  health and targeted case management programs.
 2505         3. Except as provided in subparagraph 8., by July 1, 2006,
 2506  the agency and the Department of Children and Family Services
 2507  shall contract with managed care entities in each AHCA area
 2508  except area 6 or arrange to provide comprehensive inpatient and
 2509  outpatient mental health and substance abuse services through
 2510  capitated prepaid arrangements to all Medicaid recipients who
 2511  are eligible to participate in such plans under federal law and
 2512  regulation. In AHCA areas where eligible individuals number less
 2513  than 150,000, the agency shall contract with a single managed
 2514  care plan to provide comprehensive behavioral health services to
 2515  all recipients who are not enrolled in a Medicaid health
 2516  maintenance organization, a provider service network authorized
 2517  under paragraph (d), or a Medicaid capitated managed care plan
 2518  authorized under s. 409.91211. The agency may contract with more
 2519  than one comprehensive behavioral health provider to provide
 2520  care to recipients who are not enrolled in a Medicaid capitated
 2521  managed care plan authorized under s. 409.91211, a provider
 2522  service network authorized under paragraph (d), or a Medicaid
 2523  health maintenance organization in AHCA areas where the eligible
 2524  population exceeds 150,000. In an AHCA area where the Medicaid
 2525  managed care pilot program is authorized pursuant to s.
 2526  409.91211 in one or more counties, the agency may procure a
 2527  contract with a single entity to serve the remaining counties as
 2528  an AHCA area or the remaining counties may be included with an
 2529  adjacent AHCA area and shall be subject to this paragraph.
 2530  Contracts for comprehensive behavioral health providers awarded
 2531  pursuant to this section shall be competitively procured. Both
 2532  for-profit and not-for-profit corporations are eligible to
 2533  compete. Managed care plans contracting with the agency under
 2534  subsection (3) or paragraph (d), shall provide and receive
 2535  payment for the same comprehensive behavioral health benefits as
 2536  provided in AHCA rules, including handbooks incorporated by
 2537  reference. In AHCA area 11, the agency shall contract with at
 2538  least two comprehensive behavioral health care providers to
 2539  provide behavioral health care to recipients in that area who
 2540  are enrolled in, or assigned to, the MediPass program. One of
 2541  the behavioral health care contracts must be with the existing
 2542  provider service network pilot project, as described in
 2543  paragraph (d), for the purpose of demonstrating the cost
 2544  effectiveness of the provision of quality mental health services
 2545  through a public hospital-operated managed care model. Payment
 2546  shall be at an agreed-upon capitated rate to ensure cost
 2547  savings. Of the recipients in area 11 who are assigned to
 2548  MediPass under s. 409.9122(2)(k), a minimum of 50,000 of those
 2549  MediPass-enrolled recipients shall be assigned to the existing
 2550  provider service network in area 11 for their behavioral care.
 2551         4. By October 1, 2003, the agency and the department shall
 2552  submit a plan to the Governor, the President of the Senate, and
 2553  the Speaker of the House of Representatives which provides for
 2554  the full implementation of capitated prepaid behavioral health
 2555  care in all areas of the state.
 2556         a. Implementation shall begin in 2003 in those AHCA areas
 2557  of the state where the agency is able to establish sufficient
 2558  capitation rates.
 2559         b. If the agency determines that the proposed capitation
 2560  rate in any area is insufficient to provide appropriate
 2561  services, the agency may adjust the capitation rate to ensure
 2562  that care will be available. The agency and the department may
 2563  use existing general revenue to address any additional required
 2564  match but may not over-obligate existing funds on an annualized
 2565  basis.
 2566         c. Subject to any limitations provided in the General
 2567  Appropriations Act, the agency, in compliance with appropriate
 2568  federal authorization, shall develop policies and procedures
 2569  that allow for certification of local and state funds.
 2570         5. Children residing in a statewide inpatient psychiatric
 2571  program, or in a Department of Juvenile Justice or a Department
 2572  of Children and Family Services residential program approved as
 2573  a Medicaid behavioral health overlay services provider may not
 2574  be included in a behavioral health care prepaid health plan or
 2575  any other Medicaid managed care plan pursuant to this paragraph.
 2576         6. In converting to a prepaid system of delivery, the
 2577  agency shall in its procurement document require an entity
 2578  providing only comprehensive behavioral health care services to
 2579  prevent the displacement of indigent care patients by enrollees
 2580  in the Medicaid prepaid health plan providing behavioral health
 2581  care services from facilities receiving state funding to provide
 2582  indigent behavioral health care, to facilities licensed under
 2583  chapter 395 which do not receive state funding for indigent
 2584  behavioral health care, or reimburse the unsubsidized facility
 2585  for the cost of behavioral health care provided to the displaced
 2586  indigent care patient.
 2587         7. Traditional community mental health providers under
 2588  contract with the Department of Children and Family Services
 2589  pursuant to part IV of chapter 394, child welfare providers
 2590  under contract with the Department of Children and Family
 2591  Services in areas 1 and 6, and inpatient mental health providers
 2592  licensed pursuant to chapter 395 must be offered an opportunity
 2593  to accept or decline a contract to participate in any provider
 2594  network for prepaid behavioral health services.
 2595         8. All Medicaid-eligible children, except children in area
 2596  1 and children in Highlands County, Hardee County, Polk County,
 2597  or Manatee County of area 6, that are open for child welfare
 2598  services in the HomeSafeNet system, shall receive their
 2599  behavioral health care services through a specialty prepaid plan
 2600  operated by community-based lead agencies through a single
 2601  agency or formal agreements among several agencies. The agency
 2602  shall work with the specialty plan to develop clinically
 2603  effective, evidence-based alternatives as a downward
 2604  substitution for the statewide inpatient psychiatric program and
 2605  similar residential care and institutional services. The
 2606  specialty prepaid plan must result in savings to the state
 2607  comparable to savings achieved in other Medicaid managed care
 2608  and prepaid programs. Such plan must provide mechanisms to
 2609  maximize state and local revenues. The specialty prepaid plan
 2610  shall be developed by the agency and the Department of Children
 2611  and Family Services. The agency may seek federal waivers to
 2612  implement this initiative. Medicaid-eligible children whose
 2613  cases are open for child welfare services in the HomeSafeNet
 2614  system and who reside in AHCA area 10 are exempt from the
 2615  specialty prepaid plan upon the development of a service
 2616  delivery mechanism for children who reside in area 10 as
 2617  specified in s. 409.91211(3)(dd).
 2618         (39)(a) The agency shall implement a Medicaid prescribed
 2619  drug spending-control program that includes the following
 2620  components:
 2621         1. A Medicaid preferred drug list, which shall be a listing
 2622  of cost-effective therapeutic options recommended by the
 2623  Medicaid Pharmacy and Therapeutics Committee established
 2624  pursuant to s. 409.91195 and adopted by the agency for each
 2625  therapeutic class on the preferred drug list. At the discretion
 2626  of the committee, and when feasible, the preferred drug list
 2627  should include at least two products in a therapeutic class. The
 2628  agency may post the preferred drug list and updates to the
 2629  preferred drug list on an Internet website without following the
 2630  rulemaking procedures of chapter 120. Antiretroviral agents are
 2631  excluded from the preferred drug list. The agency shall also
 2632  limit the amount of a prescribed drug dispensed to no more than
 2633  a 34-day supply unless the drug products’ smallest marketed
 2634  package is greater than a 34-day supply, or the drug is
 2635  determined by the agency to be a maintenance drug in which case
 2636  a 100-day maximum supply may be authorized. The agency is
 2637  authorized to seek any federal waivers necessary to implement
 2638  these cost-control programs and to continue participation in the
 2639  federal Medicaid rebate program, or alternatively to negotiate
 2640  state-only manufacturer rebates. The agency may adopt rules to
 2641  implement this subparagraph. The agency shall continue to
 2642  provide unlimited contraceptive drugs and items. The agency must
 2643  establish procedures to ensure that:
 2644         a. There is a response to a request for prior consultation
 2645  by telephone or other telecommunication device within 24 hours
 2646  after receipt of a request for prior consultation; and
 2647         b. A 72-hour supply of the drug prescribed is provided in
 2648  an emergency or when the agency does not provide a response
 2649  within 24 hours as required by sub-subparagraph a.
 2650         2. Reimbursement to pharmacies for Medicaid prescribed
 2651  drugs shall be set at the lesser of: the average wholesale price
 2652  (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
 2653  plus 4.75 percent, the federal upper limit (FUL), the state
 2654  maximum allowable cost (SMAC), or the usual and customary (UAC)
 2655  charge billed by the provider.
 2656         3. For a prescribed drug billed as a 340B prescribed
 2657  medication, the claim must meet the requirements of the Deficit
 2658  Reduction Act of 2005 and the federal 340B program, contain a
 2659  national drug code, and be billed at the actual acquisition cost
 2660  or payment shall be denied.
 2661         4.3. The agency shall develop and implement a process for
 2662  managing the drug therapies of Medicaid recipients who are using
 2663  significant numbers of prescribed drugs each month. The
 2664  management process may include, but is not limited to,
 2665  comprehensive, physician-directed medical-record reviews, claims
 2666  analyses, and case evaluations to determine the medical
 2667  necessity and appropriateness of a patient’s treatment plan and
 2668  drug therapies. The agency may contract with a private
 2669  organization to provide drug-program-management services. The
 2670  Medicaid drug benefit management program shall include
 2671  initiatives to manage drug therapies for HIV/AIDS patients,
 2672  patients using 20 or more unique prescriptions in a 180-day
 2673  period, and the top 1,000 patients in annual spending. The
 2674  agency shall enroll any Medicaid recipient in the drug benefit
 2675  management program if he or she meets the specifications of this
 2676  provision and is not enrolled in a Medicaid health maintenance
 2677  organization.
 2678         5.4. The agency may limit the size of its pharmacy network
 2679  based on need, competitive bidding, price negotiations,
 2680  credentialing, or similar criteria. The agency shall give
 2681  special consideration to rural areas in determining the size and
 2682  location of pharmacies included in the Medicaid pharmacy
 2683  network. A pharmacy credentialing process may include criteria
 2684  such as a pharmacy’s full-service status, location, size,
 2685  patient educational programs, patient consultation, disease
 2686  management services, and other characteristics. The agency may
 2687  impose a moratorium on Medicaid pharmacy enrollment when it is
 2688  determined that it has a sufficient number of Medicaid
 2689  participating providers. The agency must allow dispensing
 2690  practitioners to participate as a part of the Medicaid pharmacy
 2691  network regardless of the practitioner’s proximity to any other
 2692  entity that is dispensing prescription drugs under the Medicaid
 2693  program. A dispensing practitioner must meet all credentialing
 2694  requirements applicable to his or her practice, as determined by
 2695  the agency.
 2696         6.5. The agency shall develop and implement a program that
 2697  requires Medicaid practitioners who prescribe drugs to use a
 2698  counterfeit-proof prescription pad for Medicaid prescriptions.
 2699  The agency shall require the use of standardized counterfeit
 2700  proof prescription pads by Medicaid-participating prescribers or
 2701  prescribers who write prescriptions for Medicaid recipients. The
 2702  agency may implement the program in targeted geographic areas or
 2703  statewide.
 2704         7.6. The agency may enter into arrangements that require
 2705  manufacturers of generic drugs prescribed to Medicaid recipients
 2706  to provide rebates of at least 15.1 percent of the average
 2707  manufacturer price for the manufacturer’s generic products.
 2708  These arrangements shall require that if a generic-drug
 2709  manufacturer pays federal rebates for Medicaid-reimbursed drugs
 2710  at a level below 15.1 percent, the manufacturer must provide a
 2711  supplemental rebate to the state in an amount necessary to
 2712  achieve a 15.1-percent rebate level.
 2713         8.7. The agency may establish a preferred drug list as
 2714  described in this subsection, and, pursuant to the establishment
 2715  of such preferred drug list, it is authorized to negotiate
 2716  supplemental rebates from manufacturers that are in addition to
 2717  those required by Title XIX of the Social Security Act and at no
 2718  less than 14 percent of the average manufacturer price as
 2719  defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
 2720  the federal or supplemental rebate, or both, equals or exceeds
 2721  29 percent. There is no upper limit on the supplemental rebates
 2722  the agency may negotiate. The agency may determine that specific
 2723  products, brand-name or generic, are competitive at lower rebate
 2724  percentages. Agreement to pay the minimum supplemental rebate
 2725  percentage will guarantee a manufacturer that the Medicaid
 2726  Pharmaceutical and Therapeutics Committee will consider a
 2727  product for inclusion on the preferred drug list. However, a
 2728  pharmaceutical manufacturer is not guaranteed placement on the
 2729  preferred drug list by simply paying the minimum supplemental
 2730  rebate. Agency decisions will be made on the clinical efficacy
 2731  of a drug and recommendations of the Medicaid Pharmaceutical and
 2732  Therapeutics Committee, as well as the price of competing
 2733  products minus federal and state rebates. The agency is
 2734  authorized to contract with an outside agency or contractor to
 2735  conduct negotiations for supplemental rebates. For the purposes
 2736  of this section, the term “supplemental rebates” means cash
 2737  rebates. Effective July 1, 2004, value-added programs as a
 2738  substitution for supplemental rebates are prohibited. The agency
 2739  is authorized to seek any federal waivers to implement this
 2740  initiative.
 2741         9.8. The Agency for Health Care Administration shall expand
 2742  home delivery of pharmacy products. To assist Medicaid patients
 2743  in securing their prescriptions and reduce program costs, the
 2744  agency shall expand its current mail-order-pharmacy diabetes
 2745  supply program to include all generic and brand-name drugs used
 2746  by Medicaid patients with diabetes. Medicaid recipients in the
 2747  current program may obtain nondiabetes drugs on a voluntary
 2748  basis. This initiative is limited to the geographic area covered
 2749  by the current contract. The agency may seek and implement any
 2750  federal waivers necessary to implement this subparagraph.
 2751         10.9. The agency shall limit to one dose per month any drug
 2752  prescribed to treat erectile dysfunction.
 2753         11.10.a. The agency may implement a Medicaid behavioral
 2754  drug management system. The agency may contract with a vendor
 2755  that has experience in operating behavioral drug management
 2756  systems to implement this program. The agency is authorized to
 2757  seek federal waivers to implement this program.
 2758         b. The agency, in conjunction with the Department of
 2759  Children and Family Services, may implement the Medicaid
 2760  behavioral drug management system that is designed to improve
 2761  the quality of care and behavioral health prescribing practices
 2762  based on best practice guidelines, improve patient adherence to
 2763  medication plans, reduce clinical risk, and lower prescribed
 2764  drug costs and the rate of inappropriate spending on Medicaid
 2765  behavioral drugs. The program may include the following
 2766  elements:
 2767         (I) Provide for the development and adoption of best
 2768  practice guidelines for behavioral health-related drugs such as
 2769  antipsychotics, antidepressants, and medications for treating
 2770  bipolar disorders and other behavioral conditions; translate
 2771  them into practice; review behavioral health prescribers and
 2772  compare their prescribing patterns to a number of indicators
 2773  that are based on national standards; and determine deviations
 2774  from best practice guidelines.
 2775         (II) Implement processes for providing feedback to and
 2776  educating prescribers using best practice educational materials
 2777  and peer-to-peer consultation.
 2778         (III) Assess Medicaid beneficiaries who are outliers in
 2779  their use of behavioral health drugs with regard to the numbers
 2780  and types of drugs taken, drug dosages, combination drug
 2781  therapies, and other indicators of improper use of behavioral
 2782  health drugs.
 2783         (IV) Alert prescribers to patients who fail to refill
 2784  prescriptions in a timely fashion, are prescribed multiple same
 2785  class behavioral health drugs, and may have other potential
 2786  medication problems.
 2787         (V) Track spending trends for behavioral health drugs and
 2788  deviation from best practice guidelines.
 2789         (VI) Use educational and technological approaches to
 2790  promote best practices, educate consumers, and train prescribers
 2791  in the use of practice guidelines.
 2792         (VII) Disseminate electronic and published materials.
 2793         (VIII) Hold statewide and regional conferences.
 2794         (IX) Implement a disease management program with a model
 2795  quality-based medication component for severely mentally ill
 2796  individuals and emotionally disturbed children who are high
 2797  users of care.
 2798         12.11.a. The agency shall implement a Medicaid prescription
 2799  drug management system. The agency may contract with a vendor
 2800  that has experience in operating prescription drug management
 2801  systems in order to implement this system. Any management system
 2802  that is implemented in accordance with this subparagraph must
 2803  rely on cooperation between physicians and pharmacists to
 2804  determine appropriate practice patterns and clinical guidelines
 2805  to improve the prescribing, dispensing, and use of drugs in the
 2806  Medicaid program. The agency may seek federal waivers to
 2807  implement this program.
 2808         b. The drug management system must be designed to improve
 2809  the quality of care and prescribing practices based on best
 2810  practice guidelines, improve patient adherence to medication
 2811  plans, reduce clinical risk, and lower prescribed drug costs and
 2812  the rate of inappropriate spending on Medicaid prescription
 2813  drugs. The program must:
 2814         (I) Provide for the development and adoption of best
 2815  practice guidelines for the prescribing and use of drugs in the
 2816  Medicaid program, including translating best practice guidelines
 2817  into practice; reviewing prescriber patterns and comparing them
 2818  to indicators that are based on national standards and practice
 2819  patterns of clinical peers in their community, statewide, and
 2820  nationally; and determine deviations from best practice
 2821  guidelines.
 2822         (II) Implement processes for providing feedback to and
 2823  educating prescribers using best practice educational materials
 2824  and peer-to-peer consultation.
 2825         (III) Assess Medicaid recipients who are outliers in their
 2826  use of a single or multiple prescription drugs with regard to
 2827  the numbers and types of drugs taken, drug dosages, combination
 2828  drug therapies, and other indicators of improper use of
 2829  prescription drugs.
 2830         (IV) Alert prescribers to patients who fail to refill
 2831  prescriptions in a timely fashion, are prescribed multiple drugs
 2832  that may be redundant or contraindicated, or may have other
 2833  potential medication problems.
 2834         (V) Track spending trends for prescription drugs and
 2835  deviation from best practice guidelines.
 2836         (VI) Use educational and technological approaches to
 2837  promote best practices, educate consumers, and train prescribers
 2838  in the use of practice guidelines.
 2839         (VII) Disseminate electronic and published materials.
 2840         (VIII) Hold statewide and regional conferences.
 2841         (IX) Implement disease management programs in cooperation
 2842  with physicians and pharmacists, along with a model quality
 2843  based medication component for individuals having chronic
 2844  medical conditions.
 2845         13.12. The agency is authorized to contract for drug rebate
 2846  administration, including, but not limited to, calculating
 2847  rebate amounts, invoicing manufacturers, negotiating disputes
 2848  with manufacturers, and maintaining a database of rebate
 2849  collections.
 2850         14.13. The agency may specify the preferred daily dosing
 2851  form or strength for the purpose of promoting best practices
 2852  with regard to the prescribing of certain drugs as specified in
 2853  the General Appropriations Act and ensuring cost-effective
 2854  prescribing practices.
 2855         15.14. The agency may require prior authorization for
 2856  Medicaid-covered prescribed drugs. The agency may, but is not
 2857  required to, prior-authorize the use of a product:
 2858         a. For an indication not approved in labeling;
 2859         b. To comply with certain clinical guidelines; or
 2860         c. If the product has the potential for overuse, misuse, or
 2861  abuse.
 2862  
 2863  The agency may require the prescribing professional to provide
 2864  information about the rationale and supporting medical evidence
 2865  for the use of a drug. The agency shall accept electronic prior
 2866  authorization requests from prescribers or pharmacists for any
 2867  drug requiring prior authorization and may post prior
 2868  authorization criteria and protocol and updates to the list of
 2869  drugs that are subject to prior authorization on an Internet
 2870  website without amending its rule or engaging in additional
 2871  rulemaking.
 2872         16.15. The agency, in conjunction with the Pharmaceutical
 2873  and Therapeutics Committee, may require age-related prior
 2874  authorizations for certain prescribed drugs. The agency may
 2875  preauthorize the use of a drug for a recipient who may not meet
 2876  the age requirement or may exceed the length of therapy for use
 2877  of this product as recommended by the manufacturer and approved
 2878  by the Food and Drug Administration. Prior authorization may
 2879  require the prescribing professional to provide information
 2880  about the rationale and supporting medical evidence for the use
 2881  of a drug.
 2882         17.16. The agency shall implement a step-therapy prior
 2883  authorization approval process for medications excluded from the
 2884  preferred drug list. Medications listed on the preferred drug
 2885  list must be used within the previous 12 months prior to the
 2886  alternative medications that are not listed. The step-therapy
 2887  prior authorization may require the prescriber to use the
 2888  medications of a similar drug class or for a similar medical
 2889  indication unless contraindicated in the Food and Drug
 2890  Administration labeling. The trial period between the specified
 2891  steps may vary according to the medical indication. The step
 2892  therapy approval process shall be developed in accordance with
 2893  the committee as stated in s. 409.91195(7) and (8). A drug
 2894  product may be approved without meeting the step-therapy prior
 2895  authorization criteria if the prescribing physician provides the
 2896  agency with additional written medical or clinical documentation
 2897  that the product is medically necessary because:
 2898         a. There is not a drug on the preferred drug list to treat
 2899  the disease or medical condition which is an acceptable clinical
 2900  alternative;
 2901         b. The alternatives have been ineffective in the treatment
 2902  of the beneficiary’s disease; or
 2903         c. Based on historic evidence and known characteristics of
 2904  the patient and the drug, the drug is likely to be ineffective,
 2905  or the number of doses have been ineffective.
 2906  
 2907  The agency shall work with the physician to determine the best
 2908  alternative for the patient. The agency may adopt rules waiving
 2909  the requirements for written clinical documentation for specific
 2910  drugs in limited clinical situations.
 2911         18.17. The agency shall implement a return and reuse
 2912  program for drugs dispensed by pharmacies to institutional
 2913  recipients, which includes payment of a $5 restocking fee for
 2914  the implementation and operation of the program. The return and
 2915  reuse program shall be implemented electronically and in a
 2916  manner that promotes efficiency. The program must permit a
 2917  pharmacy to exclude drugs from the program if it is not
 2918  practical or cost-effective for the drug to be included and must
 2919  provide for the return to inventory of drugs that cannot be
 2920  credited or returned in a cost-effective manner. The agency
 2921  shall determine if the program has reduced the amount of
 2922  Medicaid prescription drugs which are destroyed on an annual
 2923  basis and if there are additional ways to ensure more
 2924  prescription drugs are not destroyed which could safely be
 2925  reused. The agency’s conclusion and recommendations shall be
 2926  reported to the Legislature by December 1, 2005.
 2927         (41) The agency shall establish provide for the development
 2928  of a demonstration project by establishment in Miami-Dade County
 2929  of a long-term-care facility licensed and a psychiatric facility
 2930  pursuant to chapter 395 to improve access to health care for a
 2931  predominantly minority, medically underserved, and medically
 2932  complex population and to evaluate alternatives to nursing home
 2933  care and general acute care for such population. Such project is
 2934  to be located in a health care condominium and collocated
 2935  colocated with licensed facilities providing a continuum of
 2936  care. These projects are The establishment of this project is
 2937  not subject to the provisions of s. 408.036 or s. 408.039.
 2938         Section 74. Subsection (3) and paragraph (c) of subsection
 2939  (4) of section 429.07, Florida Statutes, are amended, and
 2940  subsections (6) and (7) are added to that section, to read:
 2941         429.07 License required; fee; inspections.—
 2942         (3) In addition to the requirements of s. 408.806, each
 2943  license granted by the agency must state the type of care for
 2944  which the license is granted. Licenses shall be issued for one
 2945  or more of the following categories of care: standard, extended
 2946  congregate care, limited nursing services, or limited mental
 2947  health.
 2948         (a) A standard license shall be issued to a facility
 2949  facilities providing one or more of the personal services
 2950  identified in s. 429.02. Such licensee facilities may also
 2951  employ or contract with a person licensed under part I of
 2952  chapter 464 to administer medications and perform other tasks as
 2953  specified in s. 429.255.
 2954         (b) An extended congregate care license shall be issued to
 2955  a licensee facilities providing, directly or through contract,
 2956  services beyond those authorized in paragraph (a), including
 2957  services performed by persons licensed under part I of chapter
 2958  464 and supportive services, as defined by rule, to persons who
 2959  would otherwise be disqualified from continued residence in a
 2960  facility licensed under this part.
 2961         1. In order for extended congregate care services to be
 2962  provided, the agency must first determine that all requirements
 2963  established in law and rule are met and must specifically
 2964  designate, on the facility’s license, that such services may be
 2965  provided and whether the designation applies to all or part of
 2966  the facility. Such designation may be made at the time of
 2967  initial licensure or relicensure, or upon request in writing by
 2968  a licensee under this part and part II of chapter 408. The
 2969  notification of approval or the denial of the request shall be
 2970  made in accordance with part II of chapter 408. An existing
 2971  licensee facilities qualifying to provide extended congregate
 2972  care services must have maintained a standard license and may
 2973  not have been subject to administrative sanctions during the
 2974  previous 2 years, or since initial licensure if the facility has
 2975  been licensed for less than 2 years, for any of the following
 2976  reasons:
 2977         a. A class I or class II violation;
 2978         b. Three or more repeat or recurring class III violations
 2979  of identical or similar resident care standards from which a
 2980  pattern of noncompliance is found by the agency;
 2981         c. Three or more class III violations that were not
 2982  corrected in accordance with the corrective action plan approved
 2983  by the agency;
 2984         d. Violation of resident care standards which results in
 2985  requiring the facility to employ the services of a consultant
 2986  pharmacist or consultant dietitian;
 2987         e. Denial, suspension, or revocation of a license for
 2988  another facility licensed under this part in which the applicant
 2989  for an extended congregate care license has at least 25 percent
 2990  ownership interest; or
 2991         f. Imposition of a moratorium pursuant to this part or part
 2992  II of chapter 408 or initiation of injunctive proceedings.
 2993         2. A facility that is licensed to provide extended
 2994  congregate care services shall maintain a written progress
 2995  report for on each person who receives services which describes
 2996  the type, amount, duration, scope, and outcome of services that
 2997  are rendered and the general status of the resident’s health. A
 2998  registered nurse, or appropriate designee, representing the
 2999  agency shall visit the facility at least quarterly to monitor
 3000  residents who are receiving extended congregate care services
 3001  and to determine if the facility is in compliance with this
 3002  part, part II of chapter 408, and relevant rules. One of the
 3003  visits may be in conjunction with the regular survey. The
 3004  monitoring visits may be provided through contractual
 3005  arrangements with appropriate community agencies. A registered
 3006  nurse shall serve as part of the team that inspects the
 3007  facility. The agency may waive one of the required yearly
 3008  monitoring visits for a facility that has been licensed for at
 3009  least 24 months to provide extended congregate care services,
 3010  if, during the inspection, the registered nurse determines that
 3011  extended congregate care services are being provided
 3012  appropriately, and if the facility has no class I or class II
 3013  violations and no uncorrected class III violations. The agency
 3014  must first consult with the long-term care ombudsman council for
 3015  the area in which the facility is located to determine if any
 3016  complaints have been made and substantiated about the quality of
 3017  services or care. The agency may not waive one of the required
 3018  yearly monitoring visits if complaints have been made and
 3019  substantiated.
 3020         3. A facility that is licensed to provide extended
 3021  congregate care services must:
 3022         a. Demonstrate the capability to meet unanticipated
 3023  resident service needs.
 3024         b. Offer a physical environment that promotes a homelike
 3025  setting, provides for resident privacy, promotes resident
 3026  independence, and allows sufficient congregate space as defined
 3027  by rule.
 3028         c. Have sufficient staff available, taking into account the
 3029  physical plant and firesafety features of the building, to
 3030  assist with the evacuation of residents in an emergency.
 3031         d. Adopt and follow policies and procedures that maximize
 3032  resident independence, dignity, choice, and decisionmaking to
 3033  permit residents to age in place, so that moves due to changes
 3034  in functional status are minimized or avoided.
 3035         e. Allow residents or, if applicable, a resident’s
 3036  representative, designee, surrogate, guardian, or attorney in
 3037  fact to make a variety of personal choices, participate in
 3038  developing service plans, and share responsibility in
 3039  decisionmaking.
 3040         f. Implement the concept of managed risk.
 3041         g. Provide, directly or through contract, the services of a
 3042  person licensed under part I of chapter 464.
 3043         h. In addition to the training mandated in s. 429.52,
 3044  provide specialized training as defined by rule for facility
 3045  staff.
 3046         4. A facility that is licensed to provide extended
 3047  congregate care services is exempt from the criteria for
 3048  continued residency set forth in rules adopted under s. 429.41.
 3049  A licensed facility must adopt its own requirements within
 3050  guidelines for continued residency set forth by rule. However,
 3051  the facility may not serve residents who require 24-hour nursing
 3052  supervision. A licensed facility that provides extended
 3053  congregate care services must also provide each resident with a
 3054  written copy of facility policies governing admission and
 3055  retention.
 3056         5. The primary purpose of extended congregate care services
 3057  is to allow residents, as they become more impaired, the option
 3058  of remaining in a familiar setting from which they would
 3059  otherwise be disqualified for continued residency. A facility
 3060  licensed to provide extended congregate care services may also
 3061  admit an individual who exceeds the admission criteria for a
 3062  facility with a standard license, if the individual is
 3063  determined appropriate for admission to the extended congregate
 3064  care facility.
 3065         6. Before the admission of an individual to a facility
 3066  licensed to provide extended congregate care services, the
 3067  individual must undergo a medical examination as provided in s.
 3068  429.26(4) and the facility must develop a preliminary service
 3069  plan for the individual.
 3070         7. When a licensee facility can no longer provide or
 3071  arrange for services in accordance with the resident’s service
 3072  plan and needs and the licensee’s facility’s policy, the
 3073  licensee facility shall make arrangements for relocating the
 3074  person in accordance with s. 429.28(1)(k).
 3075         8. Failure to provide extended congregate care services may
 3076  result in denial of extended congregate care license renewal.
 3077         (c) A limited nursing services license shall be issued to a
 3078  facility that provides services beyond those authorized in
 3079  paragraph (a) and as specified in this paragraph.
 3080         1. In order for limited nursing services to be provided in
 3081  a facility licensed under this part, the agency must first
 3082  determine that all requirements established in law and rule are
 3083  met and must specifically designate, on the facility’s license,
 3084  that such services may be provided. Such designation may be made
 3085  at the time of initial licensure or relicensure, or upon request
 3086  in writing by a licensee under this part and part II of chapter
 3087  408. Notification of approval or denial of such request shall be
 3088  made in accordance with part II of chapter 408. Existing
 3089  facilities qualifying to provide limited nursing services shall
 3090  have maintained a standard license and may not have been subject
 3091  to administrative sanctions that affect the health, safety, and
 3092  welfare of residents for the previous 2 years or since initial
 3093  licensure if the facility has been licensed for less than 2
 3094  years.
 3095         2. Facilities that are licensed to provide limited nursing
 3096  services shall maintain a written progress report on each person
 3097  who receives such nursing services, which report describes the
 3098  type, amount, duration, scope, and outcome of services that are
 3099  rendered and the general status of the resident’s health. A
 3100  registered nurse representing the agency shall visit such
 3101  facilities at least twice a year to monitor residents who are
 3102  receiving limited nursing services and to determine if the
 3103  facility is in compliance with applicable provisions of this
 3104  part, part II of chapter 408, and related rules. The monitoring
 3105  visits may be provided through contractual arrangements with
 3106  appropriate community agencies. A registered nurse shall also
 3107  serve as part of the team that inspects such facility.
 3108         3. A person who receives limited nursing services under
 3109  this part must meet the admission criteria established by the
 3110  agency for assisted living facilities. When a resident no longer
 3111  meets the admission criteria for a facility licensed under this
 3112  part, arrangements for relocating the person shall be made in
 3113  accordance with s. 429.28(1)(k), unless the facility is licensed
 3114  to provide extended congregate care services.
 3115         (4) In accordance with s. 408.805, an applicant or licensee
 3116  shall pay a fee for each license application submitted under
 3117  this part, part II of chapter 408, and applicable rules. The
 3118  amount of the fee shall be established by rule.
 3119         (c) In addition to the total fee assessed under paragraph
 3120  (a), the agency shall require facilities that are licensed to
 3121  provide limited nursing services under this part to pay an
 3122  additional fee per licensed facility. The amount of the biennial
 3123  fee shall be $250 per license, with an additional fee of $10 per
 3124  resident based on the total licensed resident capacity of the
 3125  facility.
 3126         (6) In order to determine whether the facility is
 3127  adequately protecting residents’ rights as provided in s.
 3128  429.28, the agency’s standard licensure survey shall include
 3129  private informal conversations with a sample of residents and
 3130  consultation with the ombudsman council in the planning and
 3131  service area in which the facility is located to discuss
 3132  residents’ experiences within the facility.
 3133         (7) An assisted living facility that has been cited within
 3134  the previous 24-month period for a class I or class II
 3135  violation, regardless of the status of any enforcement or
 3136  disciplinary action, is subject to periodic unannounced
 3137  monitoring to determine if the facility is in compliance with
 3138  this part, part II of chapter 408, and applicable rules.
 3139  Monitoring may occur through a desk review or an onsite
 3140  assessment. If the class I or class II violation relates to
 3141  providing or failing to provide nursing care, a registered nurse
 3142  must participate in monitoring activities during the 12-month
 3143  period following the violation.
 3144         Section 75. Subsection (2) of section 429.075, Florida
 3145  Statutes, is amended to read:
 3146         429.075 Limited mental health license.—An assisted living
 3147  facility that serves three or more mental health residents must
 3148  obtain a limited mental health license.
 3149         (2) Facilities licensed to provide services to mental
 3150  health residents shall provide appropriate supervision and
 3151  staffing to provide for the health, safety, and welfare of such
 3152  residents. In a municipality having a population of more than
 3153  300,000 residents, an assisted living facility or a community
 3154  residential home located within an area zoned as a residential
 3155  area must maintain 24-hour security services if the assisted
 3156  living facility or a community residential home has:
 3157         (a) Residents who are identified as being part of a
 3158  priority population; and
 3159         (b) Adult residents and adolescent residents who have
 3160  severe and persistent mental illnesses or substance abuse
 3161  disorders as described in s. 394.674.
 3162         Section 76. Subsection (7) of section 429.11, Florida
 3163  Statutes, is renumbered as subsection (6), and present
 3164  subsection (6) of that section is amended to read:
 3165         429.11 Initial application for license; provisional
 3166  license.—
 3167         (6) In addition to the license categories available in s.
 3168  408.808, a provisional license may be issued to an applicant
 3169  making initial application for licensure or making application
 3170  for a change of ownership. A provisional license shall be
 3171  limited in duration to a specific period of time not to exceed 6
 3172  months, as determined by the agency.
 3173         Section 77. Section 429.12, Florida Statutes, is amended to
 3174  read:
 3175         429.12 Sale or transfer of ownership of a facility.—It is
 3176  the intent of the Legislature to protect the rights of the
 3177  residents of an assisted living facility when the facility is
 3178  sold or the ownership thereof is transferred. Therefore, in
 3179  addition to the requirements of part II of chapter 408, whenever
 3180  a facility is sold or the ownership thereof is transferred,
 3181  including leasing,:
 3182         (1) the transferee shall notify the residents, in writing,
 3183  of the change of ownership within 7 days after receipt of the
 3184  new license.
 3185         (2) The transferor of a facility the license of which is
 3186  denied pending an administrative hearing shall, as a part of the
 3187  written change-of-ownership contract, advise the transferee that
 3188  a plan of correction must be submitted by the transferee and
 3189  approved by the agency at least 7 days before the change of
 3190  ownership and that failure to correct the condition which
 3191  resulted in the moratorium pursuant to part II of chapter 408 or
 3192  denial of licensure is grounds for denial of the transferee’s
 3193  license.
 3194         Section 78. Subsection (5) of section 429.14, Florida
 3195  Statutes, is amended to read:
 3196         429.14 Administrative penalties.—
 3197         (5) An action taken by the agency to suspend, deny, or
 3198  revoke a facility’s license under this part or part II of
 3199  chapter 408, in which the agency claims that the facility owner
 3200  or an employee of the facility has threatened the health,
 3201  safety, or welfare of a resident of the facility, shall be heard
 3202  by the Division of Administrative Hearings of the Department of
 3203  Management Services within 120 days after receipt of the
 3204  facility’s request for a hearing, unless that time limitation is
 3205  waived by both parties. The administrative law judge must render
 3206  a decision within 30 days after receipt of a proposed
 3207  recommended order.
 3208         Section 79. Subsections (1), (4), and (5) of section
 3209  429.17, Florida Statutes, are amended to read:
 3210         429.17 Expiration of license; renewal; conditional
 3211  license.—
 3212         (1) Limited nursing, Extended congregate care, and limited
 3213  mental health licenses shall expire at the same time as the
 3214  facility’s standard license, regardless of when issued.
 3215         (4) In addition to the license categories available in s.
 3216  408.808, a conditional license may be issued to an applicant for
 3217  license renewal if the applicant fails to meet all standards and
 3218  requirements for licensure. A conditional license issued under
 3219  this subsection shall be limited in duration to a specific
 3220  period of time not to exceed 6 months, as determined by the
 3221  agency, and shall be accompanied by an agency-approved plan of
 3222  correction.
 3223         (5) When an extended congregate care or limited nursing
 3224  license is requested during a facility’s biennial license
 3225  period, the fee shall be prorated in order to permit the
 3226  additional license to expire at the end of the biennial license
 3227  period. The fee shall be calculated as of the date the
 3228  additional license application is received by the agency.
 3229         Section 80. Section 429.195, Florida Statutes, is amended
 3230  to read:
 3231         429.195 Rebates prohibited; penalties.—
 3232         (1) It is unlawful for any assisted living facility
 3233  licensed under this part to contract or promise to pay or
 3234  receive any commission, bonus, kickback, or rebate or engage in
 3235  any split-fee arrangement in any form whatsoever with any health
 3236  care provider or health care facility pursuant to s. 817.505
 3237  physician, surgeon, organization, agency, or person, either
 3238  directly or indirectly, for residents referred to an assisted
 3239  living facility licensed under this part. A facility may employ
 3240  or contract with persons to market the facility, provided the
 3241  employee or contract provider clearly indicates that he or she
 3242  represents the facility. A person or agency independent of the
 3243  facility may provide placement or referral services for a fee to
 3244  individuals seeking assistance in finding a suitable facility;
 3245  however, any fee paid for placement or referral services must be
 3246  paid by the individual looking for a facility, not by the
 3247  facility.
 3248         (2) A violation of this section shall be considered patient
 3249  brokering and is punishable as provided in s. 817.505.
 3250         (3) This section does not apply to:
 3251         (a) An individual employed by the facility, or with whom
 3252  the facility contracts to market the facility, if the employee
 3253  or contract provider clearly indicates that he or she works with
 3254  or for the facility.
 3255         (b) A referral service that provides information,
 3256  consultation, or referrals to consumers to assist them in
 3257  finding appropriate care or housing options for seniors or
 3258  disabled adults, provided that such referred consumers are not
 3259  Medicaid recipients.
 3260         (c) Residents of an assisted living facility who refer
 3261  friends, family members, or other individuals with whom they
 3262  have a personal relationship to the assisted living facility,
 3263  and does not prohibit the assisted living facility from
 3264  providing a monetary reward to the resident for making such a
 3265  referral.
 3266         Section 81. Subsections (6) through (10) of section 429.23,
 3267  Florida Statutes, are renumbered as subsections (5) through (9),
 3268  respectively, and present subsection (5) of that section is
 3269  amended to read:
 3270         429.23 Internal risk management and quality assurance
 3271  program; adverse incidents and reporting requirements.—
 3272         (5) Each facility shall report monthly to the agency any
 3273  liability claim filed against it. The report must include the
 3274  name of the resident, the dates of the incident leading to the
 3275  claim, if applicable, and the type of injury or violation of
 3276  rights alleged to have occurred. This report is not discoverable
 3277  in any civil or administrative action, except in such actions
 3278  brought by the agency to enforce the provisions of this part.
 3279         Section 82. Paragraph (a) of subsection (1) and subsection
 3280  (2) of section 429.255, Florida Statutes, are amended to read:
 3281         429.255 Use of personnel; emergency care.—
 3282         (1)(a) Persons under contract to the facility or, facility
 3283  staff, or volunteers, who are licensed according to part I of
 3284  chapter 464, or those persons exempt under s. 464.022(1), and
 3285  others as defined by rule, may administer medications to
 3286  residents, take residents’ vital signs, manage individual weekly
 3287  pill organizers for residents who self-administer medication,
 3288  give prepackaged enemas ordered by a physician, observe
 3289  residents, document observations on the appropriate resident’s
 3290  record, report observations to the resident’s physician, and
 3291  contract or allow residents or a resident’s representative,
 3292  designee, surrogate, guardian, or attorney in fact to contract
 3293  with a third party, provided residents meet the criteria for
 3294  appropriate placement as defined in s. 429.26. Persons under
 3295  contract to the facility or facility staff who are licensed
 3296  according to part I of chapter 464 may provide limited nursing
 3297  services. Nursing assistants certified pursuant to part II of
 3298  chapter 464 may take residents’ vital signs as directed by a
 3299  licensed nurse or physician. The facility is responsible for
 3300  maintaining documentation of services provided under this
 3301  paragraph and as required by rule and for ensuring that staff
 3302  are adequately trained to monitor residents receiving these
 3303  services.
 3304         (2) In facilities licensed to provide extended congregate
 3305  care, persons under contract to the facility or, facility staff,
 3306  or volunteers, who are licensed according to part I of chapter
 3307  464, or those persons exempt under s. 464.022(1), or those
 3308  persons certified as nursing assistants pursuant to part II of
 3309  chapter 464, may also perform all duties within the scope of
 3310  their license or certification, as approved by the facility
 3311  administrator and pursuant to this part.
 3312         Section 83. Subsections (4), (5), (6), and (7) of section
 3313  429.28, Florida Statutes, are renumbered as subsections (3),
 3314  (4), (5), and (6), respectively, and present subsections (3) and
 3315  (6) of that section are amended to read:
 3316         429.28 Resident bill of rights.—
 3317         (3)(a) The agency shall conduct a survey to determine
 3318  general compliance with facility standards and compliance with
 3319  residents’ rights as a prerequisite to initial licensure or
 3320  licensure renewal.
 3321         (b) In order to determine whether the facility is
 3322  adequately protecting residents’ rights, the biennial survey
 3323  shall include private informal conversations with a sample of
 3324  residents and consultation with the ombudsman council in the
 3325  planning and service area in which the facility is located to
 3326  discuss residents’ experiences within the facility.
 3327         (c) During any calendar year in which no survey is
 3328  conducted, the agency shall conduct at least one monitoring
 3329  visit of each facility cited in the previous year for a class I
 3330  or class II violation, or more than three uncorrected class III
 3331  violations.
 3332         (d) The agency may conduct periodic followup inspections as
 3333  necessary to monitor the compliance of facilities with a history
 3334  of any class I, class II, or class III violations that threaten
 3335  the health, safety, or security of residents.
 3336         (e) The agency may conduct complaint investigations as
 3337  warranted to investigate any allegations of noncompliance with
 3338  requirements required under this part or rules adopted under
 3339  this part.
 3340         (5)(6) Any facility which terminates the residency of an
 3341  individual who participated in activities specified in
 3342  subsection (4)(5) shall show good cause in a court of competent
 3343  jurisdiction.
 3344         Section 84. Subsections (4) and (5) of section 429.41,
 3345  Florida Statutes, are renumbered as subsections (3) and (4),
 3346  respectively, and paragraphs (i) and (j) of subsection (1) and
 3347  present subsection (3) of that section are amended to read:
 3348         429.41 Rules establishing standards.—
 3349         (1) It is the intent of the Legislature that rules
 3350  published and enforced pursuant to this section shall include
 3351  criteria by which a reasonable and consistent quality of
 3352  resident care and quality of life may be ensured and the results
 3353  of such resident care may be demonstrated. Such rules shall also
 3354  ensure a safe and sanitary environment that is residential and
 3355  noninstitutional in design or nature. It is further intended
 3356  that reasonable efforts be made to accommodate the needs and
 3357  preferences of residents to enhance the quality of life in a
 3358  facility. The agency, in consultation with the department, may
 3359  adopt rules to administer the requirements of part II of chapter
 3360  408. In order to provide safe and sanitary facilities and the
 3361  highest quality of resident care accommodating the needs and
 3362  preferences of residents, the department, in consultation with
 3363  the agency, the Department of Children and Family Services, and
 3364  the Department of Health, shall adopt rules, policies, and
 3365  procedures to administer this part, which must include
 3366  reasonable and fair minimum standards in relation to:
 3367         (i) Facilities holding an a limited nursing, extended
 3368  congregate care, or limited mental health license.
 3369         (j) The establishment of specific criteria to define
 3370  appropriateness of resident admission and continued residency in
 3371  a facility holding a standard, limited nursing, extended
 3372  congregate care, and limited mental health license.
 3373         (3) The department shall submit a copy of proposed rules to
 3374  the Speaker of the House of Representatives, the President of
 3375  the Senate, and appropriate committees of substance for review
 3376  and comment prior to the promulgation thereof. Rules promulgated
 3377  by the department shall encourage the development of homelike
 3378  facilities which promote the dignity, individuality, personal
 3379  strengths, and decisionmaking ability of residents.
 3380         Section 85. Subsections (1) and (2) of section 429.53,
 3381  Florida Statutes, are amended to read:
 3382         429.53 Consultation by the agency.—
 3383         (1) The area offices of licensure and certification of the
 3384  agency shall provide consultation to the following upon request:
 3385         (a) A licensee of a facility.
 3386         (b) A person interested in obtaining a license to operate a
 3387  facility under this part.
 3388         (2) As used in this section, “consultation” includes:
 3389         (a) An explanation of the requirements of this part and
 3390  rules adopted pursuant thereto;
 3391         (b) An explanation of the license application and renewal
 3392  procedures; and
 3393         (c) The provision of a checklist of general local and state
 3394  approvals required prior to constructing or developing a
 3395  facility and a listing of the types of agencies responsible for
 3396  such approvals;
 3397         (d) An explanation of benefits and financial assistance
 3398  available to a recipient of supplemental security income
 3399  residing in a facility;
 3400         (c)(e) Any other information which the agency deems
 3401  necessary to promote compliance with the requirements of this
 3402  part; and
 3403         (f) A preconstruction review of a facility to ensure
 3404  compliance with agency rules and this part.
 3405         Section 86. Subsections (1) and (2) of section 429.54,
 3406  Florida Statutes, are renumbered as subsections (2) and (3),
 3407  respectively, and subsection (1) is added to that section, to
 3408  read:
 3409         429.54 Collection of information; local subsidy.—
 3410         (1) A facility that is licensed under this part must report
 3411  electronically to the agency semiannually data related to the
 3412  facility, including, but not limited to, the total number of
 3413  residents, the number of residents who are receiving limited
 3414  mental health services, the number of residents who are
 3415  receiving extended congregate care services, the number of
 3416  residents who are receiving limited nursing services, and
 3417  professional staffing employed by or under contract with the
 3418  licensee to provide resident services. The department, in
 3419  consultation with the agency, shall adopt rules to administer
 3420  this subsection.
 3421         Section 87. Subsection (6) of section 429.71, Florida
 3422  Statutes, is renumbered as subsection (5), and subsection (1)
 3423  and present subsection (5) of that section are amended to read:
 3424         429.71 Classification of violations deficiencies;
 3425  administrative fines.—
 3426         (1) In addition to the requirements of part II of chapter
 3427  408 and in addition to any other liability or penalty provided
 3428  by law, the agency may impose an administrative fine on a
 3429  provider according to the following classification:
 3430         (a) Class I violations are defined in s. 408.813 those
 3431  conditions or practices related to the operation and maintenance
 3432  of an adult family-care home or to the care of residents which
 3433  the agency determines present an imminent danger to the
 3434  residents or guests of the facility or a substantial probability
 3435  that death or serious physical or emotional harm would result
 3436  therefrom. The condition or practice that constitutes a class I
 3437  violation must be abated or eliminated within 24 hours, unless a
 3438  fixed period, as determined by the agency, is required for
 3439  correction. A class I violation deficiency is subject to an
 3440  administrative fine in an amount not less than $500 and not
 3441  exceeding $1,000 for each violation. A fine may be levied
 3442  notwithstanding the correction of the deficiency.
 3443         (b) Class II violations are defined in s. 408.813 those
 3444  conditions or practices related to the operation and maintenance
 3445  of an adult family-care home or to the care of residents which
 3446  the agency determines directly threaten the physical or
 3447  emotional health, safety, or security of the residents, other
 3448  than class I violations. A class II violation is subject to an
 3449  administrative fine in an amount not less than $250 and not
 3450  exceeding $500 for each violation. A citation for a class II
 3451  violation must specify the time within which the violation is
 3452  required to be corrected. If a class II violation is corrected
 3453  within the time specified, no civil penalty shall be imposed,
 3454  unless it is a repeated offense.
 3455         (c) Class III violations are defined in s. 408.813 those
 3456  conditions or practices related to the operation and maintenance
 3457  of an adult family-care home or to the care of residents which
 3458  the agency determines indirectly or potentially threaten the
 3459  physical or emotional health, safety, or security of residents,
 3460  other than class I or class II violations. A class III violation
 3461  is subject to an administrative fine in an amount not less than
 3462  $100 and not exceeding $250 for each violation. A citation for a
 3463  class III violation shall specify the time within which the
 3464  violation is required to be corrected. If a class III violation
 3465  is corrected within the time specified, no civil penalty shall
 3466  be imposed, unless it is a repeated violation offense.
 3467         (d) Class IV violations are defined in s. 408.813 those
 3468  conditions or occurrences related to the operation and
 3469  maintenance of an adult family-care home, or related to the
 3470  required reports, forms, or documents, which do not have the
 3471  potential of negatively affecting the residents. A provider that
 3472  does not correct A class IV violation within the time limit
 3473  specified by the agency is subject to an administrative fine in
 3474  an amount not less than $50 and not exceeding $100 for each
 3475  violation. Any class IV violation that is corrected during the
 3476  time the agency survey is conducted will be identified as an
 3477  agency finding and not as a violation, unless it is a repeat
 3478  violation.
 3479         (5) As an alternative to or in conjunction with an
 3480  administrative action against a provider, the agency may request
 3481  a plan of corrective action that demonstrates a good faith
 3482  effort to remedy each violation by a specific date, subject to
 3483  the approval of the agency.
 3484         Section 88. Section 429.915, Florida Statutes, is amended
 3485  to read:
 3486         429.915 Conditional license.—In addition to the license
 3487  categories available in part II of chapter 408, the agency may
 3488  issue a conditional license to an applicant for license renewal
 3489  or change of ownership if the applicant fails to meet all
 3490  standards and requirements for licensure. A conditional license
 3491  issued under this subsection must be limited to a specific
 3492  period not exceeding 6 months, as determined by the agency, and
 3493  must be accompanied by an approved plan of correction.
 3494         Section 89. Paragraphs (b) and (g) of subsection (3) of
 3495  section 430.80, Florida Statutes, are amended to read:
 3496         430.80 Implementation of a teaching nursing home pilot
 3497  project.—
 3498         (3) To be designated as a teaching nursing home, a nursing
 3499  home licensee must, at a minimum:
 3500         (b) Participate in a nationally recognized accreditation
 3501  program and hold a valid accreditation, such as the
 3502  accreditation awarded by the Joint Commission on Accreditation
 3503  of Healthcare Organizations, or, at the time of initial
 3504  designation, possess a Gold Seal Award as conferred by the state
 3505  on its licensed nursing home;
 3506         (g) Maintain insurance coverage pursuant to s.
 3507  400.141(1)(q)(s) or proof of financial responsibility in a
 3508  minimum amount of $750,000. Such proof of financial
 3509  responsibility may include:
 3510         1. Maintaining an escrow account consisting of cash or
 3511  assets eligible for deposit in accordance with s. 625.52; or
 3512         2. Obtaining and maintaining pursuant to chapter 675 an
 3513  unexpired, irrevocable, nontransferable and nonassignable letter
 3514  of credit issued by any bank or savings association organized
 3515  and existing under the laws of this state or any bank or savings
 3516  association organized under the laws of the United States that
 3517  has its principal place of business in this state or has a
 3518  branch office which is authorized to receive deposits in this
 3519  state. The letter of credit shall be used to satisfy the
 3520  obligation of the facility to the claimant upon presentment of a
 3521  final judgment indicating liability and awarding damages to be
 3522  paid by the facility or upon presentment of a settlement
 3523  agreement signed by all parties to the agreement when such final
 3524  judgment or settlement is a result of a liability claim against
 3525  the facility.
 3526         Section 90. Paragraph (d) of subsection (9) of section
 3527  440.102, Florida Statutes, is amended to read:
 3528         440.102 Drug-free workplace program requirements.—The
 3529  following provisions apply to a drug-free workplace program
 3530  implemented pursuant to law or to rules adopted by the Agency
 3531  for Health Care Administration:
 3532         (9) DRUG-TESTING STANDARDS FOR LABORATORIES.—
 3533         (d) The laboratory shall submit to the Agency for Health
 3534  Care Administration a monthly report with statistical
 3535  information regarding the testing of employees and job
 3536  applicants. The report must include information on the methods
 3537  of analysis conducted, the drugs tested for, the number of
 3538  positive and negative results for both initial tests and
 3539  confirmation tests, and any other information deemed appropriate
 3540  by the Agency for Health Care Administration. A monthly report
 3541  must not identify specific employees or job applicants.
 3542         Section 91. Paragraph (a) of subsection (2) of section
 3543  440.13, Florida Statutes, is amended to read:
 3544         440.13 Medical services and supplies; penalty for
 3545  violations; limitations.—
 3546         (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.—
 3547         (a) Subject to the limitations specified elsewhere in this
 3548  chapter, the employer shall furnish to the employee such
 3549  medically necessary remedial treatment, care, and attendance for
 3550  such period as the nature of the injury or the process of
 3551  recovery may require, which is in accordance with established
 3552  practice parameters and protocols of treatment as provided for
 3553  in this chapter, including medicines, medical supplies, durable
 3554  medical equipment, orthoses, prostheses, and other medically
 3555  necessary apparatus. Remedial treatment, care, and attendance,
 3556  including work-hardening programs or pain-management programs
 3557  accredited by the Commission on Accreditation of Rehabilitation
 3558  Facilities or the Joint Commission on the Accreditation of
 3559  Health Organizations or pain-management programs affiliated with
 3560  medical schools, shall be considered as covered treatment only
 3561  when such care is given based on a referral by a physician as
 3562  defined in this chapter. Medically necessary treatment, care,
 3563  and attendance does not include chiropractic services in excess
 3564  of 24 treatments or rendered 12 weeks beyond the date of the
 3565  initial chiropractic treatment, whichever comes first, unless
 3566  the carrier authorizes additional treatment or the employee is
 3567  catastrophically injured.
 3568  
 3569  Failure of the carrier to timely comply with this subsection
 3570  shall be a violation of this chapter and the carrier shall be
 3571  subject to penalties as provided for in s. 440.525.
 3572         Section 92. Paragraph (h) of subsection (3) of section
 3573  456.053, Florida Statutes, is amended to read:
 3574         456.053 Financial arrangements between referring health
 3575  care providers and providers of health care services.—
 3576         (3) DEFINITIONS.—For the purpose of this section, the word,
 3577  phrase, or term:
 3578         (h) “Group practice” means a group of two or more health
 3579  care providers legally organized as a partnership, professional
 3580  corporation, or similar association:
 3581         1.a. In which each health care provider who is a member of
 3582  the group provides substantially the full range of services
 3583  which the health care provider routinely provides, including
 3584  medical care, consultation, diagnosis, or treatment, through the
 3585  joint use of shared office space, facilities, equipment, and
 3586  personnel;
 3587         b.2. For which substantially all of the services of the
 3588  health care providers who are members of the group are provided
 3589  through the group and are billed in the name of the group and
 3590  amounts so received are treated as receipts of the group; and
 3591         c.3. In which the overhead expenses of and the income from
 3592  the practice are distributed in accordance with methods
 3593  previously determined by members of the group.
 3594         2. If the group provides radiation therapy services:
 3595         a. The group accepts and treats cancer patients under
 3596  provider contracts for medical services under s. 409.912 for
 3597  Medicaid;
 3598         b. The group provides the full range of radiation therapy
 3599  services such that no single type of cancer, either as a primary
 3600  or secondary diagnosis and as described by the International
 3601  Statistical Classification of Diseases, shall constitute 40
 3602  percent or more of the group’s cases for professional and
 3603  technical services for radiation therapy services, where a case
 3604  is defined as an individual patient’s radiation treatment
 3605  course; and
 3606         c. The health care providers other than physicians
 3607  specializing in the provision of radiation therapy services or
 3608  medical oncology services shall not own 50 percent or more of
 3609  the group practice.
 3610         Section 93. Subsection (1) of section 483.035, Florida
 3611  Statutes, is amended to read:
 3612         483.035 Clinical laboratories operated by practitioners for
 3613  exclusive use; licensure and regulation.—
 3614         (1) A clinical laboratory operated by one or more
 3615  practitioners licensed under chapter 458, chapter 459, chapter
 3616  460, chapter 461, chapter 462, chapter 463, part I of chapter
 3617  464, or chapter 466, exclusively in connection with the
 3618  diagnosis and treatment of their own patients, must be licensed
 3619  under this part and must comply with the provisions of this
 3620  part, except that the agency shall adopt rules for staffing, for
 3621  personnel, including education and training of personnel, for
 3622  proficiency testing, and for construction standards relating to
 3623  the licensure and operation of the laboratory based upon and not
 3624  exceeding the same standards contained in the federal Clinical
 3625  Laboratory Improvement Amendments of 1988 and the federal
 3626  regulations adopted thereunder.
 3627         Section 94. Subsections (1) and (9) of section 483.051,
 3628  Florida Statutes, are amended to read:
 3629         483.051 Powers and duties of the agency.—The agency shall
 3630  adopt rules to implement this part, which rules must include,
 3631  but are not limited to, the following:
 3632         (1) LICENSING; QUALIFICATIONS.—The agency shall provide for
 3633  biennial licensure of all nonwaived clinical laboratories
 3634  meeting the requirements of this part and shall prescribe the
 3635  qualifications necessary for such licensure, including, but not
 3636  limited to, application for or proof of a federal Clinical
 3637  Laboratory Improvement Amendment (CLIA) certificate. For
 3638  purposes of this section, the term “nonwaived clinical
 3639  laboratories” means laboratories that perform any test that the
 3640  Centers for Medicare and Medicaid Services has determined does
 3641  not qualify for a certificate of waiver under the Clinical
 3642  Laboratory Improvement Amendments of 1988 and the federal rules
 3643  adopted thereunder.
 3644         (9) ALTERNATE-SITE TESTING.—The agency, in consultation
 3645  with the Board of Clinical Laboratory Personnel, shall adopt, by
 3646  rule, the criteria for alternate-site testing to be performed
 3647  under the supervision of a clinical laboratory director. The
 3648  elements to be addressed in the rule include, but are not
 3649  limited to: a hospital internal needs assessment; a protocol of
 3650  implementation including tests to be performed and who will
 3651  perform the tests; criteria to be used in selecting the method
 3652  of testing to be used for alternate-site testing; minimum
 3653  training and education requirements for those who will perform
 3654  alternate-site testing, such as documented training, licensure,
 3655  certification, or other medical professional background not
 3656  limited to laboratory professionals; documented inservice
 3657  training as well as initial and ongoing competency validation;
 3658  an appropriate internal and external quality control protocol;
 3659  an internal mechanism for identifying and tracking alternate
 3660  site testing by the central laboratory; and recordkeeping
 3661  requirements. Alternate-site testing locations must register
 3662  when the clinical laboratory applies to renew its license. For
 3663  purposes of this subsection, the term “alternate-site testing”
 3664  means any laboratory testing done under the administrative
 3665  control of a hospital, but performed out of the physical or
 3666  administrative confines of the central laboratory.
 3667         Section 95. Section 483.294, Florida Statutes, is amended
 3668  to read:
 3669         483.294 Inspection of centers.—In accordance with s.
 3670  408.811, the agency shall biennially, at least once annually,
 3671  inspect the premises and operations of all centers subject to
 3672  licensure under this part.
 3673         Section 96. Paragraph (a) of subsection (54) of section
 3674  499.003, Florida Statutes, is amended to read:
 3675         499.003 Definitions of terms used in this part.—As used in
 3676  this part, the term:
 3677         (54) “Wholesale distribution” means distribution of
 3678  prescription drugs to persons other than a consumer or patient,
 3679  but does not include:
 3680         (a) Any of the following activities, which is not a
 3681  violation of s. 499.005(21) if such activity is conducted in
 3682  accordance with s. 499.01(2)(g):
 3683         1. The purchase or other acquisition by a hospital or other
 3684  health care entity that is a member of a group purchasing
 3685  organization of a prescription drug for its own use from the
 3686  group purchasing organization or from other hospitals or health
 3687  care entities that are members of that organization.
 3688         2. The sale, purchase, or trade of a prescription drug or
 3689  an offer to sell, purchase, or trade a prescription drug by a
 3690  charitable organization described in s. 501(c)(3) of the
 3691  Internal Revenue Code of 1986, as amended and revised, to a
 3692  nonprofit affiliate of the organization to the extent otherwise
 3693  permitted by law.
 3694         3. The sale, purchase, or trade of a prescription drug or
 3695  an offer to sell, purchase, or trade a prescription drug among
 3696  hospitals or other health care entities that are under common
 3697  control. For purposes of this subparagraph, “common control”
 3698  means the power to direct or cause the direction of the
 3699  management and policies of a person or an organization, whether
 3700  by ownership of stock, by voting rights, by contract, or
 3701  otherwise.
 3702         4. The sale, purchase, trade, or other transfer of a
 3703  prescription drug from or for any federal, state, or local
 3704  government agency or any entity eligible to purchase
 3705  prescription drugs at public health services prices pursuant to
 3706  Pub. L. No. 102-585, s. 602 to a contract provider or its
 3707  subcontractor for eligible patients of the agency or entity
 3708  under the following conditions:
 3709         a. The agency or entity must obtain written authorization
 3710  for the sale, purchase, trade, or other transfer of a
 3711  prescription drug under this subparagraph from the State Surgeon
 3712  General or his or her designee.
 3713         b. The contract provider or subcontractor must be
 3714  authorized by law to administer or dispense prescription drugs.
 3715         c. In the case of a subcontractor, the agency or entity
 3716  must be a party to and execute the subcontract.
 3717         d. A contract provider or subcontractor must maintain
 3718  separate and apart from other prescription drug inventory any
 3719  prescription drugs of the agency or entity in its possession.
 3720         d.e. The contract provider and subcontractor must maintain
 3721  and produce immediately for inspection all records of movement
 3722  or transfer of all the prescription drugs belonging to the
 3723  agency or entity, including, but not limited to, the records of
 3724  receipt and disposition of prescription drugs. Each contractor
 3725  and subcontractor dispensing or administering these drugs must
 3726  maintain and produce records documenting the dispensing or
 3727  administration. Records that are required to be maintained
 3728  include, but are not limited to, a perpetual inventory itemizing
 3729  drugs received and drugs dispensed by prescription number or
 3730  administered by patient identifier, which must be submitted to
 3731  the agency or entity quarterly.
 3732         e.f. The contract provider or subcontractor may administer
 3733  or dispense the prescription drugs only to the eligible patients
 3734  of the agency or entity or must return the prescription drugs
 3735  for or to the agency or entity. The contract provider or
 3736  subcontractor must require proof from each person seeking to
 3737  fill a prescription or obtain treatment that the person is an
 3738  eligible patient of the agency or entity and must, at a minimum,
 3739  maintain a copy of this proof as part of the records of the
 3740  contractor or subcontractor required under sub-subparagraph e.
 3741         f.g. In addition to the departmental inspection authority
 3742  set forth in s. 499.051, the establishment of the contract
 3743  provider and subcontractor and all records pertaining to
 3744  prescription drugs subject to this subparagraph shall be subject
 3745  to inspection by the agency or entity. All records relating to
 3746  prescription drugs of a manufacturer under this subparagraph
 3747  shall be subject to audit by the manufacturer of those drugs,
 3748  without identifying individual patient information.
 3749         Section 97. Subsection (1) of section 627.645, Florida
 3750  Statutes, is amended to read:
 3751         627.645 Denial of health insurance claims restricted.—
 3752         (1) No claim for payment under a health insurance policy or
 3753  self-insured program of health benefits for treatment, care, or
 3754  services in a licensed hospital which is accredited by the Joint
 3755  Commission on the Accreditation of Hospitals, the American
 3756  Osteopathic Association, or the Commission on the Accreditation
 3757  of Rehabilitative Facilities shall be denied because such
 3758  hospital lacks major surgical facilities and is primarily of a
 3759  rehabilitative nature, if such rehabilitation is specifically
 3760  for treatment of physical disability.
 3761         Section 98. Paragraph (c) of subsection (2) of section
 3762  627.668, Florida Statutes, is amended to read:
 3763         627.668 Optional coverage for mental and nervous disorders
 3764  required; exception.—
 3765         (2) Under group policies or contracts, inpatient hospital
 3766  benefits, partial hospitalization benefits, and outpatient
 3767  benefits consisting of durational limits, dollar amounts,
 3768  deductibles, and coinsurance factors shall not be less favorable
 3769  than for physical illness generally, except that:
 3770         (c) Partial hospitalization benefits shall be provided
 3771  under the direction of a licensed physician. For purposes of
 3772  this part, the term “partial hospitalization services” is
 3773  defined as those services offered by a program accredited by the
 3774  Joint Commission on Accreditation of Hospitals (JCAH) or in
 3775  compliance with equivalent standards. Alcohol rehabilitation
 3776  programs accredited by the Joint Commission on Accreditation of
 3777  Hospitals or approved by the state and licensed drug abuse
 3778  rehabilitation programs shall also be qualified providers under
 3779  this section. In any benefit year, if partial hospitalization
 3780  services or a combination of inpatient and partial
 3781  hospitalization are utilized, the total benefits paid for all
 3782  such services shall not exceed the cost of 30 days of inpatient
 3783  hospitalization for psychiatric services, including physician
 3784  fees, which prevail in the community in which the partial
 3785  hospitalization services are rendered. If partial
 3786  hospitalization services benefits are provided beyond the limits
 3787  set forth in this paragraph, the durational limits, dollar
 3788  amounts, and coinsurance factors thereof need not be the same as
 3789  those applicable to physical illness generally.
 3790         Section 99. Subsection (3) of section 627.669, Florida
 3791  Statutes, is amended to read:
 3792         627.669 Optional coverage required for substance abuse
 3793  impaired persons; exception.—
 3794         (3) The benefits provided under this section shall be
 3795  applicable only if treatment is provided by, or under the
 3796  supervision of, or is prescribed by, a licensed physician or
 3797  licensed psychologist and if services are provided in a program
 3798  accredited by the Joint Commission on Accreditation of Hospitals
 3799  or approved by the state.
 3800         Section 100. Paragraph (a) of subsection (1) of section
 3801  627.736, Florida Statutes, is amended to read:
 3802         627.736 Required personal injury protection benefits;
 3803  exclusions; priority; claims.—
 3804         (1) REQUIRED BENEFITS.—Every insurance policy complying
 3805  with the security requirements of s. 627.733 shall provide
 3806  personal injury protection to the named insured, relatives
 3807  residing in the same household, persons operating the insured
 3808  motor vehicle, passengers in such motor vehicle, and other
 3809  persons struck by such motor vehicle and suffering bodily injury
 3810  while not an occupant of a self-propelled vehicle, subject to
 3811  the provisions of subsection (2) and paragraph (4)(e), to a
 3812  limit of $10,000 for loss sustained by any such person as a
 3813  result of bodily injury, sickness, disease, or death arising out
 3814  of the ownership, maintenance, or use of a motor vehicle as
 3815  follows:
 3816         (a) Medical benefits.—Eighty percent of all reasonable
 3817  expenses for medically necessary medical, surgical, X-ray,
 3818  dental, and rehabilitative services, including prosthetic
 3819  devices, and medically necessary ambulance, hospital, and
 3820  nursing services. However, the medical benefits shall provide
 3821  reimbursement only for such services and care that are lawfully
 3822  provided, supervised, ordered, or prescribed by a physician
 3823  licensed under chapter 458 or chapter 459, a dentist licensed
 3824  under chapter 466, or a chiropractic physician licensed under
 3825  chapter 460 or that are provided by any of the following persons
 3826  or entities:
 3827         1. A hospital or ambulatory surgical center licensed under
 3828  chapter 395.
 3829         2. A person or entity licensed under ss. 401.2101-401.45
 3830  that provides emergency transportation and treatment.
 3831         3. An entity wholly owned by one or more physicians
 3832  licensed under chapter 458 or chapter 459, chiropractic
 3833  physicians licensed under chapter 460, or dentists licensed
 3834  under chapter 466 or by such practitioner or practitioners and
 3835  the spouse, parent, child, or sibling of that practitioner or
 3836  those practitioners.
 3837         4. An entity wholly owned, directly or indirectly, by a
 3838  hospital or hospitals.
 3839         5. A health care clinic licensed under ss. 400.990-400.995
 3840  that is:
 3841         a. Accredited by the Joint Commission on Accreditation of
 3842  Healthcare Organizations, the American Osteopathic Association,
 3843  the Commission on Accreditation of Rehabilitation Facilities, or
 3844  the Accreditation Association for Ambulatory Health Care, Inc.;
 3845  or
 3846         b. A health care clinic that:
 3847         (I) Has a medical director licensed under chapter 458,
 3848  chapter 459, or chapter 460;
 3849         (II) Has been continuously licensed for more than 3 years
 3850  or is a publicly traded corporation that issues securities
 3851  traded on an exchange registered with the United States
 3852  Securities and Exchange Commission as a national securities
 3853  exchange; and
 3854         (III) Provides at least four of the following medical
 3855  specialties:
 3856         (A) General medicine.
 3857         (B) Radiography.
 3858         (C) Orthopedic medicine.
 3859         (D) Physical medicine.
 3860         (E) Physical therapy.
 3861         (F) Physical rehabilitation.
 3862         (G) Prescribing or dispensing outpatient prescription
 3863  medication.
 3864         (H) Laboratory services.
 3865  
 3866  The Financial Services Commission shall adopt by rule the form
 3867  that must be used by an insurer and a health care provider
 3868  specified in subparagraph 3., subparagraph 4., or subparagraph
 3869  5. to document that the health care provider meets the criteria
 3870  of this paragraph, which rule must include a requirement for a
 3871  sworn statement or affidavit.
 3872  
 3873  Only insurers writing motor vehicle liability insurance in this
 3874  state may provide the required benefits of this section, and no
 3875  such insurer shall require the purchase of any other motor
 3876  vehicle coverage other than the purchase of property damage
 3877  liability coverage as required by s. 627.7275 as a condition for
 3878  providing such required benefits. Insurers may not require that
 3879  property damage liability insurance in an amount greater than
 3880  $10,000 be purchased in conjunction with personal injury
 3881  protection. Such insurers shall make benefits and required
 3882  property damage liability insurance coverage available through
 3883  normal marketing channels. Any insurer writing motor vehicle
 3884  liability insurance in this state who fails to comply with such
 3885  availability requirement as a general business practice shall be
 3886  deemed to have violated part IX of chapter 626, and such
 3887  violation shall constitute an unfair method of competition or an
 3888  unfair or deceptive act or practice involving the business of
 3889  insurance; and any such insurer committing such violation shall
 3890  be subject to the penalties afforded in such part, as well as
 3891  those which may be afforded elsewhere in the insurance code.
 3892         Section 101. Section 633.081, Florida Statutes, is amended
 3893  to read:
 3894         633.081 Inspection of buildings and equipment; orders;
 3895  firesafety inspection training requirements; certification;
 3896  disciplinary action.—The State Fire Marshal and her or his
 3897  agents shall, at any reasonable hour, when the State Fire
 3898  Marshal has reasonable cause to believe that a violation of this
 3899  chapter or s. 509.215, or a rule promulgated thereunder, or a
 3900  minimum firesafety code adopted by a local authority, may exist,
 3901  inspect any and all buildings and structures which are subject
 3902  to the requirements of this chapter or s. 509.215 and rules
 3903  promulgated thereunder. The authority to inspect shall extend to
 3904  all equipment, vehicles, and chemicals which are located within
 3905  the premises of any such building or structure. The State Fire
 3906  Marshal and her or his agents shall inspect nursing homes
 3907  licensed under part II of chapter 400 only once every calendar
 3908  year and upon receiving a complaint forming the basis of a
 3909  reasonable cause to believe that a violation of this chapter or
 3910  s. 509.215, or a rule promulgated thereunder, or a minimum
 3911  firesafety code adopted by a local authority may exist and upon
 3912  identifying such a violation in the course of conducting
 3913  orientation or training activities within a nursing home.
 3914         (1) Each county, municipality, and special district that
 3915  has firesafety enforcement responsibilities shall employ or
 3916  contract with a firesafety inspector. Except as provided in s.
 3917  633.082(2), the firesafety inspector must conduct all firesafety
 3918  inspections that are required by law. The governing body of a
 3919  county, municipality, or special district that has firesafety
 3920  enforcement responsibilities may provide a schedule of fees to
 3921  pay only the costs of inspections conducted pursuant to this
 3922  subsection and related administrative expenses. Two or more
 3923  counties, municipalities, or special districts that have
 3924  firesafety enforcement responsibilities may jointly employ or
 3925  contract with a firesafety inspector.
 3926         (2) Except as provided in s. 633.082(2), every firesafety
 3927  inspection conducted pursuant to state or local firesafety
 3928  requirements shall be by a person certified as having met the
 3929  inspection training requirements set by the State Fire Marshal.
 3930  Such person shall:
 3931         (a) Be a high school graduate or the equivalent as
 3932  determined by the department;
 3933         (b) Not have been found guilty of, or having pleaded guilty
 3934  or nolo contendere to, a felony or a crime punishable by
 3935  imprisonment of 1 year or more under the law of the United
 3936  States, or of any state thereof, which involves moral turpitude,
 3937  without regard to whether a judgment of conviction has been
 3938  entered by the court having jurisdiction of such cases;
 3939         (c) Have her or his fingerprints on file with the
 3940  department or with an agency designated by the department;
 3941         (d) Have good moral character as determined by the
 3942  department;
 3943         (e) Be at least 18 years of age;
 3944         (f) Have satisfactorily completed the firesafety inspector
 3945  certification examination as prescribed by the department; and
 3946         (g)1. Have satisfactorily completed, as determined by the
 3947  department, a firesafety inspector training program of not less
 3948  than 200 hours established by the department and administered by
 3949  agencies and institutions approved by the department for the
 3950  purpose of providing basic certification training for firesafety
 3951  inspectors; or
 3952         2. Have received in another state training which is
 3953  determined by the department to be at least equivalent to that
 3954  required by the department for approved firesafety inspector
 3955  education and training programs in this state.
 3956         (3) Each special state firesafety inspection which is
 3957  required by law and is conducted by or on behalf of an agency of
 3958  the state must be performed by an individual who has met the
 3959  provision of subsection (2), except that the duration of the
 3960  training program shall not exceed 120 hours of specific training
 3961  for the type of property that such special state firesafety
 3962  inspectors are assigned to inspect.
 3963         (4) A firefighter certified pursuant to s. 633.35 may
 3964  conduct firesafety inspections, under the supervision of a
 3965  certified firesafety inspector, while on duty as a member of a
 3966  fire department company conducting inservice firesafety
 3967  inspections without being certified as a firesafety inspector,
 3968  if such firefighter has satisfactorily completed an inservice
 3969  fire department company inspector training program of at least
 3970  24 hours’ duration as provided by rule of the department.
 3971         (5) Every firesafety inspector or special state firesafety
 3972  inspector certificate is valid for a period of 3 years from the
 3973  date of issuance. Renewal of certification shall be subject to
 3974  the affected person’s completing proper application for renewal
 3975  and meeting all of the requirements for renewal as established
 3976  under this chapter or by rule promulgated thereunder, which
 3977  shall include completion of at least 40 hours during the
 3978  preceding 3-year period of continuing education as required by
 3979  the rule of the department or, in lieu thereof, successful
 3980  passage of an examination as established by the department.
 3981         (6) The State Fire Marshal may deny, refuse to renew,
 3982  suspend, or revoke the certificate of a firesafety inspector or
 3983  special state firesafety inspector if it finds that any of the
 3984  following grounds exist:
 3985         (a) Any cause for which issuance of a certificate could
 3986  have been refused had it then existed and been known to the
 3987  State Fire Marshal.
 3988         (b) Violation of this chapter or any rule or order of the
 3989  State Fire Marshal.
 3990         (c) Falsification of records relating to the certificate.
 3991         (d) Having been found guilty of or having pleaded guilty or
 3992  nolo contendere to a felony, whether or not a judgment of
 3993  conviction has been entered.
 3994         (e) Failure to meet any of the renewal requirements.
 3995         (f) Having been convicted of a crime in any jurisdiction
 3996  which directly relates to the practice of fire code inspection,
 3997  plan review, or administration.
 3998         (g) Making or filing a report or record that the
 3999  certificateholder knows to be false, or knowingly inducing
 4000  another to file a false report or record, or knowingly failing
 4001  to file a report or record required by state or local law, or
 4002  knowingly impeding or obstructing such filing, or knowingly
 4003  inducing another person to impede or obstruct such filing.
 4004         (h) Failing to properly enforce applicable fire codes or
 4005  permit requirements within this state which the
 4006  certificateholder knows are applicable by committing willful
 4007  misconduct, gross negligence, gross misconduct, repeated
 4008  negligence, or negligence resulting in a significant danger to
 4009  life or property.
 4010         (i) Accepting labor, services, or materials at no charge or
 4011  at a noncompetitive rate from any person who performs work that
 4012  is under the enforcement authority of the certificateholder and
 4013  who is not an immediate family member of the certificateholder.
 4014  For the purpose of this paragraph, the term “immediate family
 4015  member” means a spouse, child, parent, sibling, grandparent,
 4016  aunt, uncle, or first cousin of the person or the person’s
 4017  spouse or any person who resides in the primary residence of the
 4018  certificateholder.
 4019         (7) The Division of State Fire Marshal and the Florida
 4020  Building Code Administrators and Inspectors Board, established
 4021  pursuant to s. 468.605, shall enter into a reciprocity agreement
 4022  to facilitate joint recognition of continuing education
 4023  recertification hours for certificateholders licensed under s.
 4024  468.609 and firesafety inspectors certified under subsection
 4025  (2).
 4026         (8) The State Fire Marshal shall develop by rule an
 4027  advanced training and certification program for firesafety
 4028  inspectors having fire code management responsibilities. The
 4029  program must be consistent with the appropriate provisions of
 4030  NFPA 1037, or similar standards adopted by the division, and
 4031  establish minimum training, education, and experience levels for
 4032  firesafety inspectors having fire code management
 4033  responsibilities.
 4034         (9) The department shall provide by rule for the
 4035  certification of firesafety inspectors.
 4036         Section 102. Subsection (12) of section 641.495, Florida
 4037  Statutes, is amended to read:
 4038         641.495 Requirements for issuance and maintenance of
 4039  certificate.—
 4040         (12) The provisions of part I of chapter 395 do not apply
 4041  to a health maintenance organization that, on or before January
 4042  1, 1991, provides not more than 10 outpatient holding beds for
 4043  short-term and hospice-type patients in an ambulatory care
 4044  facility for its members, provided that such health maintenance
 4045  organization maintains current accreditation by the Joint
 4046  Commission on Accreditation of Health Care Organizations, the
 4047  Accreditation Association for Ambulatory Health Care, or the
 4048  National Committee for Quality Assurance.
 4049         Section 103. Subsection (13) of section 651.118, Florida
 4050  Statutes, is amended to read:
 4051         651.118 Agency for Health Care Administration; certificates
 4052  of need; sheltered beds; community beds.—
 4053         (13) Residents, as defined in this chapter, are not
 4054  considered new admissions for the purpose of s.
 4055  400.141(1)(n)(o)1.d.
 4056         Section 104. Subsection (2) of section 766.1015, Florida
 4057  Statutes, is amended to read:
 4058         766.1015 Civil immunity for members of or consultants to
 4059  certain boards, committees, or other entities.—
 4060         (2) Such committee, board, group, commission, or other
 4061  entity must be established in accordance with state law or in
 4062  accordance with requirements of the Joint Commission on
 4063  Accreditation of Healthcare Organizations, established and duly
 4064  constituted by one or more public or licensed private hospitals
 4065  or behavioral health agencies, or established by a governmental
 4066  agency. To be protected by this section, the act, decision,
 4067  omission, or utterance may not be made or done in bad faith or
 4068  with malicious intent.
 4069         Section 105. Subsection (4) of section 766.202, Florida
 4070  Statutes, is amended to read:
 4071         766.202 Definitions; ss. 766.201-766.212.—As used in ss.
 4072  766.201-766.212, the term:
 4073         (4) “Health care provider” means any hospital, ambulatory
 4074  surgical center, or mobile surgical facility as defined and
 4075  licensed under chapter 395; a birth center licensed under
 4076  chapter 383; any person licensed under chapter 458, chapter 459,
 4077  chapter 460, chapter 461, chapter 462, chapter 463, part I of
 4078  chapter 464, chapter 466, chapter 467, part XIV of chapter 468,
 4079  or chapter 486; a clinical lab licensed under chapter 483; a
 4080  health maintenance organization certificated under part I of
 4081  chapter 641; a blood bank; a plasma center; an industrial
 4082  clinic; a renal dialysis facility; or a professional association
 4083  partnership, corporation, joint venture, or other association
 4084  for professional activity by health care providers.
 4085         Section 106. Paragraph (j) is added to subsection (3) of
 4086  section 817.505, Florida Statutes, to read:
 4087         817.505 Patient brokering prohibited; exceptions;
 4088  penalties.—
 4089         (3) This section shall not apply to:
 4090         (j) Any payments by an assisted living facility, as defined
 4091  in s. 429.02, or any agreement for or solicitation, offer, or
 4092  receipt of such payment by a referral service, which is
 4093  permitted under s. 429.195(3).
 4094         Section 107. The per-bed standard assisted living facility
 4095  licensure fees, including the total fee, have been adjusted by
 4096  the Consumer Price Index annually since 1998 and are not
 4097  intended to be reset by this act. In addition to the Consumer
 4098  Price Index adjustment, the per-bed fee is increased by $9 to
 4099  neutralize the elimination of the limited nursing services
 4100  specialty license fee.
 4101         Section 108. Section 381.06014, Florida Statutes, is
 4102  amended to read:
 4103         381.06014 Blood establishments.—
 4104         (1) As used in this section, the term:
 4105         (a) “Blood establishment” means any person, entity, or
 4106  organization, operating within the state, which examines an
 4107  individual for the purpose of blood donation or which collects,
 4108  processes, stores, tests, or distributes blood or blood
 4109  components collected from the human body for the purpose of
 4110  transfusion, for any other medical purpose, or for the
 4111  production of any biological product. A person, entity, or
 4112  organization that uses a mobile unit to conduct such activities
 4113  within the state is also a blood establishment.
 4114         (b) “Volunteer donor” means a person who does not receive
 4115  remuneration, other than an incentive, for a blood donation
 4116  intended for transfusion, and the product container of the
 4117  donation from the person qualifies for labeling with the
 4118  statement “volunteer donor” under 21 C.F.R. s. 606.121.
 4119         (2) Any blood establishment operating in the state may not
 4120  conduct any activity defined in paragraph (1)(a) subsection (1)
 4121  unless that blood establishment is operated in a manner
 4122  consistent with the provisions of Title 21 C.F.R. parts 211 and
 4123  600-640, Code of Federal Regulations.
 4124         (3) Any blood establishment determined to be operating in
 4125  the state in a manner not consistent with the provisions of
 4126  Title 21 C.F.R. parts 211 and 600-640, Code of Federal
 4127  Regulations, and in a manner that constitutes a danger to the
 4128  health or well-being of donors or recipients as evidenced by the
 4129  federal Food and Drug Administration’s inspection reports and
 4130  the revocation of the blood establishment’s license or
 4131  registration is shall be in violation of this chapter and must
 4132  shall immediately cease all operations in the state.
 4133         (4) The operation of a blood establishment in a manner not
 4134  consistent with the provisions of Title 21 C.F.R. parts 211 and
 4135  600-640, Code of Federal Regulations, and in a manner that
 4136  constitutes a danger to the health or well-being of blood donors
 4137  or recipients as evidenced by the federal Food and Drug
 4138  Administration’s inspection process is declared a nuisance and
 4139  inimical to the public health, welfare, and safety. The Agency
 4140  for Health Care Administration or any state attorney may bring
 4141  an action for an injunction to restrain such operations or
 4142  enjoin the future operation of the blood establishment.
 4143         (5) A local government may not restrict the access to or
 4144  use of any public facility or infrastructure for the collection
 4145  of blood or blood components from volunteer donors based on
 4146  whether the blood establishment is operating as a for-profit
 4147  organization or not-for-profit organization.
 4148         (6) In determining the service fee of blood or blood
 4149  components received from volunteer donors and sold to hospitals
 4150  or other health care providers, a blood establishment may not
 4151  base the service fee of the blood or blood component solely on
 4152  whether the purchasing entity is a for-profit organization or
 4153  not-for-profit organization.
 4154         (7) A blood establishment that collects blood or blood
 4155  components from volunteer donors must disclose on the Internet
 4156  the information required under this subsection to educate and
 4157  inform donors and the public about the blood establishment’s
 4158  activities. A hospital that collects blood or blood components
 4159  to be used only by that hospital’s licensed facilities or by a
 4160  health care provider that is a part of the hospital’s business
 4161  entity is exempt from the disclosure requirements in this
 4162  subsection. The information required to be disclosed under this
 4163  subsection may be cumulative for all blood establishments within
 4164  a business entity. A blood establishment must disclose on its
 4165  website all of the following information:
 4166         (a) A description of the steps involved in collecting,
 4167  processing, and distributing volunteer donations.
 4168         (b) By March 1 of each year, the number of units of blood
 4169  components which were:
 4170         1. Produced by the blood establishment during the preceding
 4171  calendar year;
 4172         2. Obtained from other sources during the preceding
 4173  calendar year;
 4174         3. Distributed during the preceding calendar year to health
 4175  care providers located outside this state. However, if the blood
 4176  establishment collects donations in a county outside this state,
 4177  distributions to health care providers in that county shall be
 4178  excluded. Such information shall be reported in the aggregate
 4179  for health care providers located within the United States and
 4180  its territories or outside the United States and its
 4181  territories; and
 4182         4. Distributed during the preceding calendar year to
 4183  entities that are not health care providers. Such information
 4184  shall be reported in the aggregate for purchasers located within
 4185  the United States and its territories or outside the United
 4186  States and its territories.
 4187         (c) The blood establishment’s conflict-of-interest policy,
 4188  policy concerning related-party transactions, whistleblower
 4189  policy, and policy for determining executive compensation. If a
 4190  change occurs to any of these documents, the revised document
 4191  must be available on the blood establishment’s website by the
 4192  following March 1.
 4193         (d) Except for a hospital that collects blood or blood
 4194  components from volunteer donors:
 4195         1. The most recent 3 years of the Return of Organization
 4196  Exempt from Income Tax, Internal Revenue Service Form 990, if
 4197  the business entity for the blood establishment is eligible to
 4198  file such return. The Form 990 must be available on the blood
 4199  establishment’s website within 60 calendar days after it is
 4200  filed with the Internal Revenue Service; or
 4201         2. If the business entity for the blood establishment is
 4202  not eligible to file the Form 990 return, a balance sheet,
 4203  income statement, and statement of changes in cash flow, along
 4204  with the expression of an opinion thereon by an independent
 4205  certified public accountant who audited or reviewed such
 4206  financial statements. Such documents must be available on the
 4207  blood establishment’s website within 120 days after the end of
 4208  the blood establishment’s fiscal year and must remain on the
 4209  blood establishment’s website for at least 36 months.
 4210         (8) A blood establishment is liable for a civil penalty for
 4211  failing to make the disclosures required under subsection (7).
 4212  The Department of Legal Affairs may assess the civil penalty
 4213  against the blood establishment for each day that it fails to
 4214  make such required disclosures, but the penalty may not exceed
 4215  $10,000 per year. If multiple blood establishments operated by a
 4216  single business entity fail to meet such disclosure
 4217  requirements, the civil penalty may be assessed against only one
 4218  of the business entity’s blood establishments. The Department of
 4219  Legal Affairs may terminate an action if the blood establishment
 4220  agrees to pay a stipulated civil penalty. A civil penalty so
 4221  collected accrues to the state and shall be deposited as
 4222  received into the General Revenue Fund unallocated. The
 4223  Department of Legal Affairs may terminate the action and waive
 4224  the civil penalty upon a showing of good cause by the blood
 4225  establishment as to why the required disclosures were not made.
 4226         Section 109. Subsection (23) of section 499.003, Florida
 4227  Statutes, is amended to read:
 4228         499.003 Definitions of terms used in this part.—As used in
 4229  this part, the term:
 4230         (23) “Health care entity” means a closed pharmacy or any
 4231  person, organization, or business entity that provides
 4232  diagnostic, medical, surgical, or dental treatment or care, or
 4233  chronic or rehabilitative care, but does not include any
 4234  wholesale distributor or retail pharmacy licensed under state
 4235  law to deal in prescription drugs. However, a blood
 4236  establishment is a health care entity that may engage in the
 4237  wholesale distribution of prescription drugs under s.
 4238  499.01(2)(g)1.c.
 4239         Section 110. Subsection (21) of section 499.005, Florida
 4240  Statutes, is amended to read:
 4241         499.005 Prohibited acts.—It is unlawful for a person to
 4242  perform or cause the performance of any of the following acts in
 4243  this state:
 4244         (21) The wholesale distribution of any prescription drug
 4245  that was:
 4246         (a) Purchased by a public or private hospital or other
 4247  health care entity; or
 4248         (b) Donated or supplied at a reduced price to a charitable
 4249  organization,
 4250  
 4251  unless the wholesale distribution of the prescription drug is
 4252  authorized in s. 499.01(2)(g)1.c.
 4253         Section 111. Paragraphs (a), (g), and (t) of subsection (2)
 4254  of section 499.01, Florida Statutes, are amended to read:
 4255         499.01 Permits.—
 4256         (2) The following permits are established:
 4257         (a) Prescription drug manufacturer permit.—A prescription
 4258  drug manufacturer permit is required for any person that is a
 4259  manufacturer of a prescription drug and that manufactures or
 4260  distributes such prescription drugs in this state.
 4261         1. A person that operates an establishment permitted as a
 4262  prescription drug manufacturer may engage in wholesale
 4263  distribution of prescription drugs manufactured at that
 4264  establishment and must comply with all of the provisions of this
 4265  part, except s. 499.01212, and the rules adopted under this
 4266  part, except s. 499.01212, which that apply to a wholesale
 4267  distributor.
 4268         2. A prescription drug manufacturer must comply with all
 4269  appropriate state and federal good manufacturing practices.
 4270         3. A blood establishment, as defined in s. 381.06014,
 4271  operating in a manner consistent with the provisions of Title 21
 4272  C.F.R. parts 211 and 600-640, and manufacturing only the
 4273  prescription drugs described in s. 499.003(54)(d) is not
 4274  required to be permitted as a prescription drug manufacturer
 4275  under this paragraph or to register products under s. 499.015.
 4276         (g) Restricted prescription drug distributor permit.—
 4277         1. A restricted prescription drug distributor permit is
 4278  required for:
 4279         a. Any person located in this state that engages in the
 4280  distribution of a prescription drug, which distribution is not
 4281  considered “wholesale distribution” under s. 499.003(54)(a).
 4282         b.1.Any A person located in this state who engages in the
 4283  receipt or distribution of a prescription drug in this state for
 4284  the purpose of processing its return or its destruction must
 4285  obtain a permit as a restricted prescription drug distributor if
 4286  such person is not the person initiating the return, the
 4287  prescription drug wholesale supplier of the person initiating
 4288  the return, or the manufacturer of the drug.
 4289         c.A blood establishment located in this state which
 4290  collects blood and blood components only from volunteer donors
 4291  as defined in s. 381.06014 or pursuant to an authorized
 4292  practitioner’s order for medical treatment or therapy and
 4293  engages in the wholesale distribution of a prescription drug not
 4294  described in s. 499.003(54)(d) to a health care entity. The
 4295  health care entity receiving a prescription drug distributed
 4296  under this sub-subparagraph must be licensed as a closed
 4297  pharmacy or provide health care services at that establishment.
 4298  The blood establishment must operate in accordance with s.
 4299  381.06014 and may distribute only:
 4300         (I) Prescription drugs indicated for a bleeding or clotting
 4301  disorder or anemia;
 4302         (II) Blood-collection containers approved under s. 505 of
 4303  the federal act;
 4304         (III) Drugs that are blood derivatives, or a recombinant or
 4305  synthetic form of a blood derivative;
 4306         (IV) Prescription drugs that are identified in rules
 4307  adopted by the department and that are essential to services
 4308  performed or provided by blood establishments and authorized for
 4309  distribution by blood establishments under federal law; or
 4310         (V) To the extent authorized by federal law, drugs
 4311  necessary to collect blood or blood components from volunteer
 4312  blood donors; for blood establishment personnel to perform
 4313  therapeutic procedures under the direction and supervision of a
 4314  licensed physician; and to diagnose, treat, manage, and prevent
 4315  any reaction of either a volunteer blood donor or a patient
 4316  undergoing a therapeutic procedure performed under the direction
 4317  and supervision of a licensed physician,
 4318  
 4319  as long as all of the health care services provided by the blood
 4320  establishment are related to its activities as a registered
 4321  blood establishment or the health care services consist of
 4322  collecting, processing, storing, or administering human
 4323  hematopoietic stem cells or progenitor cells or performing
 4324  diagnostic testing of specimens if such specimens are tested
 4325  together with specimens undergoing routine donor testing.
 4326         2. Storage, handling, and recordkeeping of these
 4327  distributions by a person required to be permitted as a
 4328  restricted prescription drug distributor must comply with the
 4329  requirements for wholesale distributors under s. 499.0121, but
 4330  not those set forth in s. 499.01212 if the distribution occurs
 4331  pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
 4332         3. A person who applies for a permit as a restricted
 4333  prescription drug distributor, or for the renewal of such a
 4334  permit, must provide to the department the information required
 4335  under s. 499.012.
 4336         4. The department may adopt rules regarding the
 4337  distribution of prescription drugs by hospitals, health care
 4338  entities, charitable organizations, or other persons not
 4339  involved in wholesale distribution, and blood establishments,
 4340  which rules are necessary for the protection of the public
 4341  health, safety, and welfare.
 4342         (t) Health care clinic establishment permit.—Effective
 4343  January 1, 2009, a health care clinic establishment permit is
 4344  required for the purchase of a prescription drug by a place of
 4345  business at one general physical location that provides health
 4346  care or veterinary services, which is owned and operated by a
 4347  business entity that has been issued a federal employer tax
 4348  identification number. For the purpose of this paragraph, the
 4349  term “qualifying practitioner” means a licensed health care
 4350  practitioner defined in s. 456.001, or a veterinarian licensed
 4351  under chapter 474, who is authorized under the appropriate
 4352  practice act to prescribe and administer a prescription drug.
 4353         1. An establishment must provide, as part of the
 4354  application required under s. 499.012, designation of a
 4355  qualifying practitioner who will be responsible for complying
 4356  with all legal and regulatory requirements related to the
 4357  purchase, recordkeeping, storage, and handling of the
 4358  prescription drugs. In addition, the designated qualifying
 4359  practitioner shall be the practitioner whose name, establishment
 4360  address, and license number is used on all distribution
 4361  documents for prescription drugs purchased or returned by the
 4362  health care clinic establishment. Upon initial appointment of a
 4363  qualifying practitioner, the qualifying practitioner and the
 4364  health care clinic establishment shall notify the department on
 4365  a form furnished by the department within 10 days after such
 4366  employment. In addition, the qualifying practitioner and health
 4367  care clinic establishment shall notify the department within 10
 4368  days after any subsequent change.
 4369         2. The health care clinic establishment must employ a
 4370  qualifying practitioner at each establishment.
 4371         3. In addition to the remedies and penalties provided in
 4372  this part, a violation of this chapter by the health care clinic
 4373  establishment or qualifying practitioner constitutes grounds for
 4374  discipline of the qualifying practitioner by the appropriate
 4375  regulatory board.
 4376         4. The purchase of prescription drugs by the health care
 4377  clinic establishment is prohibited during any period of time
 4378  when the establishment does not comply with this paragraph.
 4379         5. A health care clinic establishment permit is not a
 4380  pharmacy permit or otherwise subject to chapter 465. A health
 4381  care clinic establishment that meets the criteria of a modified
 4382  Class II institutional pharmacy under s. 465.019 is not eligible
 4383  to be permitted under this paragraph.
 4384         6. This paragraph does not apply to the purchase of a
 4385  prescription drug by a licensed practitioner under his or her
 4386  license. A professional corporation or limited liability company
 4387  composed of dentists and operating as authorized in s. 466.0285
 4388  may pay for prescription drugs obtained by a practitioner
 4389  licensed under chapter 466, and the licensed practitioner is
 4390  deemed the purchaser and owner of the prescription drugs.
 4391         Section 112. Subsection (6) of section 474.202, Florida
 4392  Statutes, is amended to read:
 4393         474.202 Definitions.—As used in this chapter:
 4394         (6) “Limited-service veterinary vaccination clinic medical
 4395  practice” means a veterinary practice at which a veterinarian
 4396  performs vaccinations or immunizations on multiple animals at a
 4397  temporary location and operates for a limited time offering or
 4398  providing veterinary services at any location that has a primary
 4399  purpose other than that of providing veterinary medical service
 4400  at a permanent or mobile establishment permitted by the board;
 4401  provides veterinary medical services for privately owned animals
 4402  that do not reside at that location; operates for a limited
 4403  time; and provides limited types of veterinary medical services.
 4404         Section 113. Subsection (7) of section 474.215, Florida
 4405  Statutes, is amended to read:
 4406         474.215 Premises permits.—
 4407         (7) The board by rule shall establish minimum standards for
 4408  the operation of limited service veterinary vaccination clinics
 4409  medical practices. Such rules shall not restrict limited service
 4410  veterinary medical practices and shall be consistent with the
 4411  type of limited veterinary vaccination and immunization services
 4412  medical service provided.
 4413         (a) Any person that offers or provides limited service
 4414  veterinary vaccination clinics medical practice shall obtain a
 4415  biennial permit from the board the cost of which shall not
 4416  exceed $250. The limited service permittee shall register each
 4417  location where a limited service veterinary vaccination clinic
 4418  is held and shall pay a fee set by rule not to exceed $25 to
 4419  register each such location.
 4420         (b) All permits issued under this subsection are subject to
 4421  the provisions of ss. 474.213 and 474.214.
 4422  (c) Notwithstanding any provision of this subsection to the
 4423  contrary, any temporary rabies vaccination effort operated by a
 4424  county health department in response to a public health threat,
 4425  as declared by the State Health Officer in consultation with the
 4426  State Veterinarian, is not subject to any preregistration, time
 4427  limitation, or fee requirements, but must adhere to all other
 4428  requirements for limited service veterinary vaccination clinics
 4429  medical practice as prescribed by rule. The fee charged to the
 4430  public for a rabies vaccination administered during such
 4431  temporary rabies vaccination effort may not exceed the actual
 4432  cost of administering the rabies vaccine. Such rabies
 4433  vaccination efforts may not be used for any purpose other than
 4434  to address the public health consequences of the rabies
 4435  outbreak. The board shall be immediately notified in writing of
 4436  any temporary rabies vaccination effort operated under this
 4437  paragraph.
 4438         Section 114. Section 455.2185, Florida Statutes, is amended
 4439  to read:
 4440         455.2185 Exemption for certain out-of-state or foreign
 4441  professionals; limited practice permitted.—
 4442         (1) A professional of any other state or of any territory
 4443  or other jurisdiction of the United States or of any other
 4444  nation or foreign jurisdiction is exempt from the requirements
 4445  of licensure under this chapter and the applicable professional
 4446  practice act under the agency with regulatory jurisdiction over
 4447  the profession if that profession is regulated in this state
 4448  under the agency with regulatory jurisdiction over the
 4449  profession and if that person:
 4450         (a) Holds, if so required in the jurisdiction in which that
 4451  person practices, an active license to practice that profession.
 4452         (b) Engages in the active practice of that profession
 4453  outside the state.
 4454         (c) Is employed or designated in that professional capacity
 4455  by a sports entity visiting the state for a specific sporting
 4456  event.
 4457         (2) A professional’s practice under this section is limited
 4458  to the members, coaches, and staff of the team for which that
 4459  professional is employed or designated and to any animals used
 4460  if the sporting event for which that professional is employed or
 4461  designated involves animals. A professional practicing under
 4462  authority of this section shall not have practice privileges in
 4463  any licensed veterinary facility without the approval of that
 4464  facility.
 4465         Section 115. Section 456.023, Florida Statutes, is amended
 4466  to read:
 4467         456.023 Exemption for certain out-of-state or foreign
 4468  professionals; limited practice permitted.—
 4469         (1) A professional of any other state or of any territory
 4470  or other jurisdiction of the United States or of any other
 4471  nation or foreign jurisdiction is exempt from the requirements
 4472  of licensure under this chapter and the applicable professional
 4473  practice act under the agency with regulatory jurisdiction over
 4474  the profession if that profession is regulated in this state
 4475  under the agency with regulatory jurisdiction over the
 4476  profession and if that person:
 4477         (a) Holds, if so required in the jurisdiction in which that
 4478  person practices, an active license to practice that profession.
 4479         (b) Engages in the active practice of that profession
 4480  outside the state.
 4481         (c) Is employed or designated in that professional capacity
 4482  by a sports entity visiting the state for a specific sporting
 4483  event.
 4484         (2) A professional’s practice under this section is limited
 4485  to the members, coaches, and staff of the team for which that
 4486  professional is employed or designated and to any animals used
 4487  if the sporting event for which that professional is employed or
 4488  designated involves animals. A professional practicing under
 4489  authority of this section shall not have practice privileges in
 4490  any licensed health care facility or veterinary facility without
 4491  the approval of that facility.
 4492         Section 116. Section 456.0635, Florida Statutes, is amended
 4493  to read:
 4494         456.0635 Health care Medicaid fraud; disqualification for
 4495  license, certificate, or registration.—
 4496         (1) Medicaid Fraud in the practice of a health care
 4497  profession is prohibited.
 4498         (2) Each board within the jurisdiction of the department,
 4499  or the department if there is no board, shall refuse to admit a
 4500  candidate to any examination and refuse to issue or renew a
 4501  license, certificate, or registration to any applicant if the
 4502  candidate or applicant or any principal, officer, agent,
 4503  managing employee, or affiliated person of the applicant, has
 4504  been:
 4505         (a) Has been convicted of, or entered a plea of guilty or
 4506  nolo contendere to, regardless of adjudication, a felony under
 4507  chapter 409, chapter 817, or chapter 893, or a similar felony
 4508  offense committed in another state or jurisdiction 21 U.S.C. ss.
 4509  801-970, or 42 U.S.C. ss. 1395-1396, unless the sentence and any
 4510  subsequent period of probation for such conviction or plea pleas
 4511  ended: more than 15 years prior to the date of the application;
 4512         1.For felonies of the first or second degree, more than 15
 4513  years before the date of application.
 4514         2.For felonies of the third degree, more than 10 years
 4515  before the date of application, except for felonies of the third
 4516  degree under s. 893.13(6)(a).
 4517         3.For felonies of the third degree under s. 893.13(6)(a),
 4518  more than 5 years before the date of application.
 4519  
 4520  Notwithstanding s. 120.60, for felonies in which the defendant
 4521  entered a plea of guilty or nolo contendere in an agreement with
 4522  the court to enter a pretrial intervention or drug diversion
 4523  program, the board, or the department if there is no board, may
 4524  not approve or deny the application for a license, certificate,
 4525  or registration until the final resolution of the case;
 4526         (b)Has been convicted of, or entered a plea of guilty or
 4527  nolo contendere to, regardless of adjudication, a felony under
 4528  21 U.S.C. ss. 801-970, or 42 U.S.C. ss. 1395-1396, unless the
 4529  sentence and any subsequent period of probation for such
 4530  conviction or plea ended more than 15 years before the date of
 4531  the application;
 4532         (c)(b)Has been terminated for cause from the Florida
 4533  Medicaid program pursuant to s. 409.913, unless the applicant
 4534  has been in good standing with the Florida Medicaid program for
 4535  the most recent 5 years;
 4536         (d)(c)Has been terminated for cause, pursuant to the
 4537  appeals procedures established by the state or Federal
 4538  Government, from any other state Medicaid program or the federal
 4539  Medicare program, unless the applicant has been in good standing
 4540  with a state Medicaid program or the federal Medicare program
 4541  for the most recent 5 years and the termination occurred at
 4542  least 20 years before prior to the date of the application; or.
 4543         (e)Is currently listed on the United States Department of
 4544  Health and Human Services Office of Inspector General’s List of
 4545  Excluded Individuals and Entities.
 4546  
 4547  This subsection does not apply to applicants for initial
 4548  licensure or certification who were enrolled in an educational
 4549  or training program on or before July 1, 2010, which was
 4550  recognized by a board or, if there is no board, recognized by
 4551  the department, and who applied for licensure after July 1,
 4552  2010.
 4553         (3)The department shall refuse to renew a license,
 4554  certificate, or registration of any applicant if the candidate
 4555  or applicant or any principal, officer, agent, managing
 4556  employee, or affiliated person of the applicant:
 4557         (a)Has been convicted of, or entered a plea of guilty or
 4558  nolo contendere to, regardless of adjudication, a felony under:
 4559  chapter 409, chapter 817, or chapter 893, or a similar felony
 4560  offense committed in another state or jurisdiction since July 1,
 4561  2010.
 4562         (b)Has been convicted of, or entered a plea of guilty or
 4563  nolo contendere to, regardless of adjudication, a felony under
 4564  21 U.S.C. ss. 801-970, or 42 U.S.C. ss. 1395-1396 since July 1,
 4565  2010.
 4566         (c)Has been terminated for cause from the Florida Medicaid
 4567  program pursuant to s. 409.913, unless the applicant has been in
 4568  good standing with the Florida Medicaid program for the most
 4569  recent 5 years.
 4570         (d)Has been terminated for cause, pursuant to the appeals
 4571  procedures established by the state, from any other state
 4572  Medicaid program, unless the applicant has been in good standing
 4573  with a state Medicaid program for the most recent 5 years and
 4574  the termination occurred at least 20 years before the date of
 4575  the application.
 4576         (e)Is currently listed on the United States Department of
 4577  Health and Human Services Office of Inspector General’s List of
 4578  Excluded Individuals and Entities.
 4579  
 4580  For felonies in which the defendant entered a plea of guilty or
 4581  nolo contendere in an agreement with the court to enter a
 4582  pretrial intervention or drug diversion program, the department
 4583  may not approve or deny the application for a renewal of a
 4584  license, certificate, or registration until the final resolution
 4585  of the case.
 4586         (4)(3) Licensed health care practitioners shall report
 4587  allegations of health care Medicaid fraud to the department,
 4588  regardless of the practice setting in which the alleged Medicaid
 4589  fraud occurred.
 4590         (5)(4) The acceptance by a licensing authority of a
 4591  candidate’s relinquishment of a license which is offered in
 4592  response to or anticipation of the filing of administrative
 4593  charges alleging health care Medicaid fraud or similar charges
 4594  constitutes the permanent revocation of the license.
 4595         Section 117. Subsection (6) of section 456.036, Florida
 4596  Statutes, is amended to read:
 4597         456.036 Licenses; active and inactive status; delinquency.—
 4598         (6)(a)Except as provided in paragraph (b), a delinquent
 4599  licensee must affirmatively apply with a complete application,
 4600  as defined by rule of the board, or the department if there is
 4601  no board, for active or inactive status during the licensure
 4602  cycle in which a licensee becomes delinquent. Failure by a
 4603  delinquent licensee to become active or inactive before the
 4604  expiration of the current licensure cycle renders the license
 4605  null without any further action by the board or the department.
 4606  Any subsequent licensure shall be as a result of applying for
 4607  and meeting all requirements imposed on an applicant for new
 4608  licensure.
 4609         (b) A delinquent licensee whose license becomes delinquent
 4610  before the final resolution of a case under s. 456.0635(3) must
 4611  affirmatively apply by submitting a complete application, as
 4612  defined by rule of the board, or the department if there is no
 4613  board, for active or inactive status during the licensure cycle
 4614  in which the case achieves final resolution by order of the
 4615  court. Failure by a delinquent licensee to become active or
 4616  inactive before the expiration of that licensure cycle renders
 4617  the license null without any further action by the board or the
 4618  department. Any subsequent licensure shall be as a result of
 4619  applying for and meeting all requirements imposed on an
 4620  applicant for new licensure.
 4621         Section 118. Subsection (9) is added to section 465.014,
 4622  Florida Statutes, to read:
 4623         465.014 Pharmacy technician.—
 4624         (9) This section does not apply to a practitioner
 4625  authorized to dispense drugs under s. 465.0276 or a medical
 4626  assistant or licensed health care professional under the direct
 4627  supervision of such practitioner if the practitioner is treating
 4628  a patient who provides proof of insurance through a public-payer
 4629  or private-payer source. The exemption provided by this
 4630  subsection applies only to medical personnel under the direct
 4631  supervision of the dispensing practitioner while dispensing in
 4632  the practitioner’s office.
 4633         Section 119. Section 627.6011, Florida Statutes, is created
 4634  to read:
 4635         627.6011Mandated coverages.—Mandatory health benefits
 4636  regulated by this chapter which must be covered by an insurer
 4637  are intended to apply only to the types of health benefit plans
 4638  defined in s. 627.6699(3)(k), issued in any market, unless
 4639  specifically designated. As used in this section, the term
 4640  “mandatory health benefits” means benefits provided in ss.
 4641  627.6401-627.64193 and any cross-references to such sections, or
 4642  any other mandatory treatments, health coverages, or benefits
 4643  enacted after the effective date of this act.
 4644         Section 120. Subsection (3) is added to section 766.110,
 4645  Florida Statutes, to read:
 4646         766.110 Liability of health care facilities.—
 4647         (3) To ensure comprehensive risk management for diagnosis
 4648  of disease, a health care facility, including a hospital or
 4649  ambulatory surgical center, as defined in chapter 395, may use
 4650  scientific diagnostic disease methodologies that use information
 4651  regarding specific diseases in health care facilities and that
 4652  are adopted by the facility’s medical review committee.
 4653         Section 121. This act shall take effect July 1, 2011.
 4654  
 4655  ================= T I T L E  A M E N D M E N T ================
 4656         And the title is amended as follows:
 4657         Delete everything before the enacting clause
 4658  and insert:
 4659                        A bill to be entitled                      
 4660         An act relating to health care; amending s. 83.42,
 4661         F.S., establishing that s. 400.0255, F.S., provides
 4662         exclusive procedures for resident transfer and
 4663         discharge; amending s. 112.0455, F.S., relating to the
 4664         Drug-Free Workplace Act; deleting an obsolete
 4665         provision; deleting a requirement that a laboratory
 4666         that conducts drug tests submit certain reports to the
 4667         Agency for Health Care Administration; amending s.
 4668         318.21, F.S.; revising distribution of funds from
 4669         civil penalties imposed for traffic infractions by
 4670         county courts; repealing s. 383.325, F.S., relating to
 4671         confidentiality of inspection reports of licensed
 4672         birth center facilities; amending s. 395.002, F.S.;
 4673         revising and deleting definitions applicable to
 4674         regulation of hospitals and other licensed facilities;
 4675         conforming a cross-reference; amending s. 395.003,
 4676         F.S.; deleting an obsolete provision; conforming a
 4677         cross-reference; amending s. 395.0161, F.S.; deleting
 4678         a provision requiring licensure inspection fees for
 4679         hospitals, ambulatory surgical centers, and mobile
 4680         surgical facilities to be paid at the time of the
 4681         inspection; amending s. 395.0193, F.S.; requiring a
 4682         licensed facility to report certain peer review
 4683         information and final disciplinary actions to the
 4684         Division of Medical Quality Assurance of the
 4685         Department of Health rather than the Division of
 4686         Health Quality Assurance of the Agency for Health Care
 4687         Administration; amending s. 395.1023, F.S.; providing
 4688         for the Department of Children and Family Services
 4689         rather than the Department of Health to perform
 4690         certain functions with respect to child protection
 4691         cases; requiring certain hospitals to notify the
 4692         Department of Children and Family Services of
 4693         compliance; amending s. 395.1041, F.S., relating to
 4694         hospital emergency services and care; deleting
 4695         obsolete provisions; repealing s. 395.1046, F.S.,
 4696         relating to complaint investigation procedures;
 4697         amending s. 395.1055, F.S.; requiring additional
 4698         housekeeping and sanitation procedures in licensed
 4699         facilities for infection control purposes; requiring
 4700         licensed facility beds to conform to standards
 4701         specified by the Agency for Health Care
 4702         Administration, the Florida Building Code, and the
 4703         Florida Fire Prevention Code; amending s. 395.10972,
 4704         F.S.; revising a reference to the Florida Society of
 4705         Healthcare Risk Management to conform to the current
 4706         designation; amending s. 395.2050, F.S.; revising a
 4707         reference to the federal Health Care Financing
 4708         Administration to conform to the current designation;
 4709         amending s. 395.3036, F.S.; correcting a reference;
 4710         repealing s. 395.3037, F.S., relating to redundant
 4711         definitions; amending ss. 154.11, 394.741, 395.3038,
 4712         400.925, 400.9935, 408.05, 440.13, 627.645, 627.668,
 4713         627.669, 627.736, 641.495, and 766.1015, F.S.;
 4714         revising references to the Joint Commission on
 4715         Accreditation of Healthcare Organizations, the
 4716         Commission on Accreditation of Rehabilitation
 4717         Facilities, and the Council on Accreditation to
 4718         conform to their current designations; amending s.
 4719         395.4025, F.S.; authorizing the Department of Health
 4720         to grant additional extensions for trauma center
 4721         applicants under certain circumstances; amending s.
 4722         395.602, F.S.; revising the definition of the term
 4723         “rural hospital” to delete an obsolete provision;
 4724         amending s. 400.021, F.S.; revising the definition of
 4725         the term “geriatric outpatient clinic” to include
 4726         additional staff; revising the term “resident care
 4727         plan”; removing a provision that requires certain
 4728         signatures on the plan; amending s. 400.0255, F.S.;
 4729         correcting an obsolete cross-reference to
 4730         administrative rules; amending s. 400.063, F.S.;
 4731         deleting an obsolete provision; amending ss. 400.071
 4732         and 400.0712, F.S.; revising applicability of general
 4733         licensure requirements under part II of ch. 408, F.S.,
 4734         the Health Care Licensing Procedures Act, to
 4735         applications for nursing home licensure; revising
 4736         provisions governing inactive licenses; amending s.
 4737         400.111, F.S.; providing for disclosure of controlling
 4738         interest of a nursing home facility upon request by
 4739         the Agency for Health Care Administration; amending s.
 4740         400.1183, F.S.; revising grievance record maintenance
 4741         and reporting requirements for nursing homes; amending
 4742         s. 400.141, F.S.; providing criteria for the provision
 4743         of respite services by nursing homes; requiring a
 4744         written plan of care; requiring a contract for
 4745         services; requiring resident release to caregivers to
 4746         be designated in writing; providing an exemption to
 4747         the application of discharge planning rules; providing
 4748         for residents’ rights; providing for use of personal
 4749         medications; providing terms of respite stay;
 4750         providing for communication of patient information;
 4751         requiring a physician’s order for care and proof of a
 4752         physical examination; providing for services for
 4753         respite patients and duties of facilities with respect
 4754         to such patients; conforming a cross-reference;
 4755         requiring facilities to maintain clinical records that
 4756         meet specified standards; providing a fine relating to
 4757         an admissions moratorium; deleting requirement for
 4758         facilities to submit certain information related to
 4759         management companies to the agency; deleting a
 4760         requirement for facilities to notify the agency of
 4761         certain bankruptcy filings to conform to changes made
 4762         by the act; providing a limit on fees charged by a
 4763         facility for copies of patient records; amending s.
 4764         400.142, F.S.; deleting language relating to agency
 4765         adoption of rules; repealing s. 400.145, F.S.,
 4766         relating to records of care and treatment of
 4767         residents; repealing ss. 400.0234 and 429.294, F.S.,
 4768         relating to availability of facility records for
 4769         investigation of resident’s rights violations and
 4770         defenses; amending 400.147, F.S.; removing a
 4771         requirement for nursing homes and related health care
 4772         facilities to notify the agency within a specified
 4773         period of time after receipt of an adverse incident
 4774         report; revising reporting requirements for licensed
 4775         nursing home facilities relating to adverse incidents;
 4776         repealing s. 400.148, F.S., relating to the Medicaid
 4777         “Up-or-Out” Quality of Care Contract Management
 4778         Program; amending s. 400.179, F.S.; deleting an
 4779         obsolete provision; amending s. 400.19, F.S.; revising
 4780         inspection requirements; amending s. 400.23, F.S.;
 4781         deleting an obsolete provision; correcting a
 4782         reference; directing the agency to adopt rules for
 4783         minimum staffing standards in nursing homes that serve
 4784         persons under 21 years of age; providing minimum
 4785         staffing standards; amending s. 400.275, F.S.;
 4786         revising agency duties with regard to training nursing
 4787         home surveyor teams; revising requirements for team
 4788         members; amending s. 400.462, F.S.; revising the
 4789         definition of the term “remuneration” as it applies to
 4790         home health agencies; amending s. 400.484, F.S.;
 4791         revising the schedule of home health agency inspection
 4792         violations; amending s. 400.506, F.S.; deleting
 4793         language relating to exemptions from penalties imposed
 4794         on nurse registries if a nurse registry does not bill
 4795         the Florida Medicaid Program; providing criteria for
 4796         an administrator to manage a nurse registry; amending
 4797         s. 400.509, F.S.; revising the service providers
 4798         exempt from licensure registration to include
 4799         organizations that provide companion services only for
 4800         persons with developmental disabilities; amending s.
 4801         400.606, F.S.; revising the content requirements of
 4802         the plan accompanying an initial or change-of
 4803         ownership application for licensure of a hospice;
 4804         revising requirements relating to certificates of need
 4805         for certain hospice facilities; amending s. 400.607,
 4806         F.S.; revising grounds for agency action against a
 4807         hospice; amending s. 400.915, F.S.; correcting an
 4808         obsolete cross-reference to administrative rules;
 4809         amending s. 400.931, F.S.; deleting a requirement that
 4810         an applicant for a home medical equipment provider
 4811         license submit a surety bond to the agency; requiring
 4812         applicants to submit documentation of accreditation
 4813         within a specified period of time; amending s.
 4814         400.932, F.S.; revising grounds for the imposition of
 4815         administrative penalties for certain violations by an
 4816         employee of a home medical equipment provider;
 4817         amending s. 400.967, F.S.; revising the schedule of
 4818         inspection violations for intermediate care facilities
 4819         for the developmentally disabled; providing a penalty
 4820         for certain violations; amending s. 400.9905, F.S.;
 4821         revising the definitions of the terms “clinic” and
 4822         “portable equipment provider”; providing that part X
 4823         of ch. 400, F.S., the Health Care Clinic Act, does not
 4824         apply to certain clinical facilities, an entity owned
 4825         by a corporation with a specified amount of annual
 4826         sales of health care services under certain
 4827         circumstances, an entity owned or controlled by a
 4828         publicly traded entity with a specified amount of
 4829         annual revenues, or an entity that employs a specified
 4830         number of licensed health care practitioners under
 4831         certain conditions; amending s. 400.991, F.S.;
 4832         conforming terminology; revising application
 4833         requirements relating to documentation of financial
 4834         ability to operate a mobile clinic; amending s.
 4835         408.033, F.S.; permitting fees assessed on certain
 4836         health care facilities to be collected prospectively
 4837         at the time of licensure renewal and prorated for the
 4838         licensure period; amending s. 408.034, F.S.; revising
 4839         agency authority relating to licensing of intermediate
 4840         care facilities for the developmentally disabled;
 4841         amending s. 408.036, F.S.; deleting an exemption from
 4842         certain certificate-of-need review requirements for a
 4843         hospice or a hospice inpatient facility; deleting a
 4844         requirement that the agency submit a report regarding
 4845         requests for exemption; amending s. 408.037, F.S.;
 4846         revising certificate-of-need requirements for general
 4847         hospital applicants to evaluate the applicant’s parent
 4848         corporation if audited financial statements of the
 4849         applicant do not exist; amending s. 408.043, F.S.;
 4850         revising requirements for certain freestanding
 4851         inpatient hospice care facilities to obtain a
 4852         certificate of need; amending s. 408.061, F.S.;
 4853         revising health care facility data reporting
 4854         requirements; amending s. 408.10, F.S.; removing
 4855         agency authority to investigate certain consumer
 4856         complaints; amending s. 408.802, F.S.; removing
 4857         applicability of part II of ch. 408, F.S., relating to
 4858         general licensure requirements, to private review
 4859         agents; amending s. 408.804, F.S.; providing penalties
 4860         for altering, defacing, or falsifying a license
 4861         certificate issued by the agency or displaying such an
 4862         altered, defaced, or falsified certificate; amending
 4863         s. 408.806, F.S.; revising agency responsibilities for
 4864         notification of licensees of impending expiration of a
 4865         license; requiring payment of a late fee for a license
 4866         application to be considered complete under certain
 4867         circumstances; amending s. 408.8065, F.S.; requiring
 4868         home health agencies, home medical equipment
 4869         providers, and health care clinics to submit projected
 4870         financial statements; amending s. 408.809, F.S.,
 4871         relating to background screening of specified
 4872         employees of health care providers; revising
 4873         provisions for required rescreening; removing
 4874         provisions authorizing the agency to adopt rules
 4875         establishing a rescreening schedule; establishing a
 4876         rescreening schedule; amending s. 408.810, F.S.;
 4877         requiring disclosure of information by a controlling
 4878         interest of certain court actions relating to
 4879         financial instability within a specified time period;
 4880         amending s. 408.813, F.S.; authorizing the agency to
 4881         impose fines for unclassified violations of part II of
 4882         ch. 408, F.S.; amending s. 408.815, F.S.; providing
 4883         for certain mitigating circumstances to be considered
 4884         for any application subject to denial; authorizing the
 4885         agency to extend a license expiration date under
 4886         certain circumstances; amending s. s. 409.212, F.S.;
 4887         increasing the limit on the amount of additional
 4888         supplementation provided by a third party under the
 4889         optional state supplementation program; amending s.
 4890         409.91196, F.S.; revising components of a Medicaid
 4891         prescribed-drug spending-control program; conforming a
 4892         cross-reference; amending s. 409.912, F.S.; requiring
 4893         the Agency for Health Care Administration to work with
 4894         the specialty prepaid plan that provides behavioral
 4895         health care services for certain Medicaid-eligible
 4896         children to develop evidence-based alternatives for
 4897         the statewide inpatient psychiatric program and other
 4898         similar services; revising procedures for
 4899         implementation of a Medicaid prescribed-drug spending
 4900         control program; requiring that the agency establish a
 4901         demonstration project in Miami-Dade County of a
 4902         psychiatric facility; amending s. 429.07, F.S.;
 4903         deleting the requirement for an assisted living
 4904         facility to obtain an additional license in order to
 4905         provide limited nursing services; deleting the
 4906         requirement for the agency to conduct quarterly
 4907         monitoring visits of facilities that hold a license to
 4908         provide extended congregate care services; deleting
 4909         the requirement for the department to report annually
 4910         on the status of and recommendations related to
 4911         extended congregate care; deleting the requirement for
 4912         the agency to conduct monitoring visits at least twice
 4913         a year to facilities providing limited nursing
 4914         services; eliminating the license fee for the limited
 4915         nursing services license; transferring from another
 4916         provision of law the requirement that the standard
 4917         survey of an assisted living facility include specific
 4918         actions to determine whether the facility is
 4919         adequately protecting residents’ rights; providing
 4920         that under specified conditions an assisted living
 4921         facility that has a class I or class II violation is
 4922         subject to periodic unannounced monitoring; requiring
 4923         a registered nurse to participate in certain
 4924         monitoring visits; amending s. 429.075, F.S.;
 4925         requiring certain facilities that have a limited
 4926         mental health license to maintain 24-hour security
 4927         services; amending s. 429.11, F.S.; revising licensure
 4928         application requirements for assisted living
 4929         facilities to eliminate provisional licenses; amending
 4930         s. 429.12, F.S.; deleting a requirement that a
 4931         transferor of an assisted living facility advise the
 4932         transferee to submit a plan for correction of certain
 4933         deficiencies to the Agency for Health Care
 4934         Administration before ownership of the facility is
 4935         transferred; amending s. 429.14, F.S.; clarifying
 4936         provisions relating to a facility’s request for a
 4937         hearing under certain circumstances; amending s.
 4938         429.17, F.S.; deleting provisions relating to the
 4939         limited nursing services license; revising agency
 4940         responsibilities regarding the issuance of conditional
 4941         licenses; amending s. 429.195, F.S.; revising the list
 4942         of entities prohibited from providing rebates;
 4943         providing exceptions to prohibited patient brokering
 4944         for assisted living facilities; amending s. 429.23,
 4945         F.S.; deleting reporting requirements for assisted
 4946         living facilities relating to liability claims;
 4947         amending s. 429.255, F.S.; eliminating provisions
 4948         authorizing the use of volunteers to provide certain
 4949         health-care-related services in assisted living
 4950         facilities; authorizing assisted living facilities to
 4951         provide limited nursing services; requiring an
 4952         assisted living facility to be responsible for certain
 4953         recordkeeping and staff to be trained to monitor
 4954         residents receiving certain health-care-related
 4955         services; amending s. 429.28, F.S.; deleting a
 4956         requirement for a biennial survey of an assisted
 4957         living facility, to conform to changes made by the
 4958         act; conforming a cross-reference; amending s. 429.41,
 4959         F.S., relating to rulemaking; conforming provisions to
 4960         changes made by the act; deleting the requirement for
 4961         the Department of Elderly Affairs to submit a copy of
 4962         proposed rules to the Legislature; amending s. 429.53,
 4963         F.S.; revising provisions relating to consultation by
 4964         the agency; revising a definition; amending s. 429.54,
 4965         F.S.; requiring licensed assisted living facilities to
 4966         electronically report certain data to the agency in
 4967         accordance with rules adopted by the department;
 4968         amending s. 429.71, F.S.; revising schedule of
 4969         inspection violations for adult family-care homes;
 4970         amending s. 429.915, F.S.; revising agency
 4971         responsibilities regarding the issuance of conditional
 4972         licenses; amending s. 440.102, F.S.; deleting the
 4973         requirement for laboratories to submit a monthly
 4974         report to the agency with statistical information
 4975         regarding the testing of employees and job applicants;
 4976         amending s. 456.053, F.S.; revising the definition of
 4977         the term “group practice” as it relates to financial
 4978         arrangements of referring health care providers and
 4979         providers of health care services to include group
 4980         practices that provide radiation therapy services
 4981         under certain circumstances; amending s. 483.035,
 4982         F.S.; requiring certain clinical laboratories operated
 4983         by one or more practitioners licensed under part I of
 4984         ch. 464, F.S., the Nurse Practice Act, and ch. 463,
 4985         F.S., the Optometry Practice Act, to be licensed under
 4986         part I of ch. 483, F.S., the Florida Clinical
 4987         Laboratory Law; amending s. 483.051, F.S.;
 4988         establishing qualifications necessary for clinical
 4989         laboratory licensure; amending s. 483.294, F.S.;
 4990         revising frequency of agency inspections of
 4991         multiphasic health testing centers; amending s.
 4992         499.003, F.S.; removing the requirement for certain
 4993         prescription drug purchasers to maintain a separate
 4994         inventory of certain prescription drugs; amending s.
 4995         633.081, F.S.; limiting State Fire Marshal inspections
 4996         of nursing homes to once a year; providing for
 4997         additional inspections based on complaints and
 4998         violations identified in the course of orientation or
 4999         training activities; amending s. 766.202, F.S.; adding
 5000         persons licensed under part XIV of ch. 468, F.S.,
 5001         relating to orthotics, prosthetics, and pedorthics, to
 5002         the definition of “health care provider”; amending s.
 5003         817.505, F.S.; creating an exception to the patient
 5004         brokering prohibition for assisted living facilities;
 5005         amending ss. 394.4787, 400.0239, 408.07, 430.80, and
 5006         651.118, F.S.; conforming terminology and references
 5007         to changes made by the act; revising a reference;
 5008         establishing that assisted living facility licensure
 5009         fees have been adjusted by Consumer Price Index since
 5010         1998 and are not intended to be reset by this act;
 5011         amending s. 381.06014, F.S.; redefining the term
 5012         “blood establishment” and defining the term “volunteer
 5013         donor”; prohibiting local governments from restricting
 5014         access to public facilities or infrastructure for
 5015         certain activities based on whether a blood
 5016         establishment is operating as a for-profit
 5017         organization or not-for-profit organization;
 5018         prohibiting a blood establishment from considering
 5019         whether certain customers are operating as for-profit
 5020         organizations or not-for-profit organizations when
 5021         determining service fees for selling blood or blood
 5022         components; requiring that certain blood
 5023         establishments disclose specified information on the
 5024         Internet; authorizing the Department of Legal Affairs
 5025         to assess a civil penalty against a blood
 5026         establishment that fails to disclose specified
 5027         information on the Internet; providing that the civil
 5028         penalty accrues to the state and requiring that it be
 5029         deposited as received into the General Revenue Fund;
 5030         amending s. 499.003, F.S.; redefining the term “health
 5031         care entity” to clarify that a blood establishment is
 5032         a health care entity that may engage in certain
 5033         activities; amending s. 499.005, F.S.; clarifying
 5034         provisions that prohibit the unauthorized wholesale
 5035         distribution of a prescription drug that was purchased
 5036         by a hospital or other health care entity or donated
 5037         or supplied at a reduced price to a charitable
 5038         organization, to conform to changes made by the act;
 5039         amending s. 499.01, F.S.; exempting certain blood
 5040         establishments from the requirements to be permitted
 5041         as a prescription drug manufacturer and register
 5042         products; requiring that certain blood establishments
 5043         obtain a restricted prescription drug distributor
 5044         permit under specified conditions; limiting the
 5045         prescription drugs that a blood establishment may
 5046         distribute under a restricted prescription drug
 5047         distributor permit; authorizing the Department of
 5048         Health to adopt rules regarding the distribution of
 5049         prescription drugs by blood establishments;
 5050         authorizing certain business entities to pay for
 5051         prescription drugs obtained by practitioners licensed
 5052         under ch. 466, F.S.; amending s. 474.202, F.S.;
 5053         defining the term “limited service veterinary
 5054         vaccination clinic”; amending s. 474.215, F.S.;
 5055         revising terminology; requiring that the Board of
 5056         Veterinary Medicine establish minimum standards for
 5057         limited service veterinary vaccination clinics rather
 5058         than limited service veterinary medical practices;
 5059         amending ss. 455.2185 and 456.023, F.S.; deleting
 5060         provisions that limit the practice privileges of out
 5061         of-state or foreign health care professionals or
 5062         veterinarians who are in this state for a specific
 5063         sporting event; amending s. 456.0635, F.S.; revising
 5064         the grounds under which the Department of Health or
 5065         corresponding board is required to refuse to admit a
 5066         candidate to an examination and to refuse to issue or
 5067         renew a license, certificate, or registration of a
 5068         health care practitioner; providing an exception;
 5069         amending s. 456.036, F.S.; requiring a delinquent
 5070         licensee whose license becomes delinquent before the
 5071         final resolution of a case regarding Medicaid fraud to
 5072         affirmatively apply by submitting a complete
 5073         application for active or inactive status during the
 5074         licensure cycle in which the case achieves final
 5075         resolution by order of the court; providing that
 5076         failure by a delinquent licensee to become active or
 5077         inactive before the expiration of that licensure cycle
 5078         renders the license null; requiring that any
 5079         subsequent licensure be as a result of applying for
 5080         and meeting all requirements imposed on an applicant
 5081         for new licensure; amending s. 465.014, F.S.;
 5082         providing that state law regarding pharmacy
 5083         technicians does not apply to a practitioner
 5084         authorized to dispense drugs or a medical assistant or
 5085         licensed health care professional under the direct
 5086         supervision of such practitioner if the practitioner
 5087         is treating a patient who provides proof of insurance
 5088         through a public-payer or private-payer source;
 5089         providing that this exemption applies only to medical
 5090         personnel under the direct supervision of the
 5091         dispensing practitioner while dispensing in the
 5092         practitioner’s office; creating s. 627.6011, F.S.;
 5093         providing clarification regarding the types of
 5094         coverage that must be included in mandatory benefits;
 5095         providing a definition; amending s. 766.110, F.S.;
 5096         authorizing health care facilities to use scientific
 5097         diagnostic disease methodologies that use information
 5098         regarding specific diseases in health care facilities
 5099         and that are adopted by the facility’s medical review
 5100         committee; providing an effective date.