Florida Senate - 2011                             CS for SB 1736
       
       
       
       By the Committee on Health Regulation; and Senator Latvala
       
       
       
       
       588-02834A-11                                         20111736c1
    1                        A bill to be entitled                      
    2         An act relating to health care; amending s. 83.42,
    3         F.S., relating to exclusions from part II of ch. 83,
    4         F.S., the Florida Residential Landlord and Tenant Act;
    5         clarifying that the procedures in s. 400.0255, F.S.,
    6         for transfers and discharges are exclusive to
    7         residents of a nursing home licensed under part II of
    8         ch. 400, F.S.; amending s. 112.0455, F.S., relating to
    9         the Drug-Free Workplace Act; deleting an obsolete
   10         provision; deleting a provision that requires a
   11         laboratory to submit to the Agency for Health Care
   12         Administration a monthly report containing statistical
   13         information regarding the testing of employees and job
   14         applicants; repealing s. 383.325, F.S., relating to
   15         confidentiality of inspection reports of licensed
   16         birth center facilities; amending s. 395.002, F.S.;
   17         revising and deleting definitions applicable to
   18         regulation of hospitals and other licensed facilities;
   19         conforming a cross-reference; amending s. 395.003,
   20         F.S.; deleting an obsolete provision; conforming a
   21         cross-reference; amending s. 395.0161, F.S.; deleting
   22         a requirement that facilities licensed under part I of
   23         ch. 395, F.S., pay licensing fees at the time of
   24         inspection; amending s. 395.0193, F.S.; requiring a
   25         licensed facility to report certain peer review
   26         information and final disciplinary actions to the
   27         Division of Medical Quality Assurance of the
   28         Department of Health rather than the Division of
   29         Health Quality Assurance of the Agency for Health Care
   30         Administration; amending s. 395.1023, F.S.; providing
   31         for the Department of Children and Family Services
   32         rather than the Department of Health to perform
   33         certain functions with respect to child protection
   34         cases; requiring certain hospitals to notify the
   35         Department of Children and Family Services of
   36         compliance; amending s. 395.1041, F.S., relating to
   37         hospital emergency services and care; deleting
   38         obsolete provisions; repealing s. 395.1046, F.S.,
   39         relating to complaint investigation procedures;
   40         amending s. 395.1055, F.S.; requiring licensed
   41         facility beds to conform to standards specified by the
   42         Agency for Health Care Administration, the Florida
   43         Building Code, and the Florida Fire Prevention Code;
   44         amending s. 395.10972, F.S.; revising a reference to
   45         the Florida Society of Healthcare Risk Management to
   46         conform to the current designation; amending s.
   47         395.2050, F.S.; revising a reference to the federal
   48         Health Care Financing Administration to conform to the
   49         current designation; amending s. 395.3036, F.S.;
   50         correcting a reference; repealing s. 395.3037, F.S.,
   51         relating to redundant definitions; amending ss.
   52         154.11, 394.741, 395.3038, 400.925, 400.9935, 408.05,
   53         440.13, 627.645, 627.668, 627.669, 627.736, 641.495,
   54         and 766.1015, F.S.; revising references to the Joint
   55         Commission on Accreditation of Healthcare
   56         Organizations, the Commission on Accreditation of
   57         Rehabilitation Facilities, and the Council on
   58         Accreditation to conform to their current
   59         designations; amending s. 395.602, F.S.; revising the
   60         definition of the term “rural hospital” to delete an
   61         obsolete provision; amending s. 400.021, F.S.;
   62         revising the definition of the terms “geriatric
   63         outpatient clinic” and “resident care plan”; amending
   64         s. 400.0234, F.S.; conforming provisions to changes
   65         made by the act; amending s. 400.0255, F.S.;
   66         correcting an obsolete cross-reference to
   67         administrative rules; amending s. 400.063, F.S.;
   68         deleting an obsolete provision; amending ss. 400.071
   69         and 400.0712, F.S.; revising applicability of general
   70         licensure requirements under part II of ch. 408, F.S.,
   71         to applications for nursing home licensure; revising
   72         provisions governing inactive licenses; amending s.
   73         400.111, F.S.; providing for disclosure of controlling
   74         interest of a nursing home facility upon request by
   75         the Agency for Health Care Administration; amending s.
   76         400.1183, F.S.; revising grievance record maintenance
   77         and reporting requirements for nursing homes; amending
   78         s. 400.141, F.S.; providing criteria for the provision
   79         of respite services by nursing homes; requiring a
   80         written plan of care; requiring a contract for
   81         services; requiring resident release to caregivers to
   82         be designated in writing; providing an exemption to
   83         the application of discharge planning rules; providing
   84         for residents’ rights; providing for use of personal
   85         medications; providing terms of respite stay;
   86         providing for communication of patient information;
   87         requiring a physician’s order for care and proof of a
   88         physical examination; providing for services for
   89         respite patients and duties of facilities with respect
   90         to such patients; conforming a cross-reference;
   91         requiring facilities to maintain clinical records that
   92         meet specified standards; providing a fine relating to
   93         an admissions moratorium; deleting requirement for
   94         facilities to submit certain information related to
   95         management companies to the agency; deleting a
   96         requirement for facilities to notify the agency of
   97         certain bankruptcy filings to conform to changes made
   98         by the act; authorizing a facility to charge a fee to
   99         copy a resident’s records; amending s. 400.142, F.S.;
  100         deleting language relating to agency adoption of
  101         rules; repealing s. 400.145, F.S., relating
  102         requirements for furnishing the records of residents
  103         in a licensed nursing home to certain specified
  104         parties; amending 400.147, F.S.; revising reporting
  105         requirements for licensed nursing home facilities
  106         relating to adverse incidents; repealing s. 400.148,
  107         F.S., relating to the Medicaid “Up-or-Out” Quality of
  108         Care Contract Management Program; amending s. 400.179,
  109         F.S.; deleting an obsolete provision; amending s.
  110         400.19, F.S.; revising inspection requirements;
  111         amending s. 400.23, F.S.; deleting an obsolete
  112         provision; correcting a reference; deleting a
  113         requirement that the rules for minimum standards of
  114         care for persons under 21 years of age include a
  115         certain methodology; directing the agency to adopt
  116         rules for minimum staffing standards in nursing homes
  117         that serve persons under 21 years of age; providing
  118         minimum staffing standards; amending s. 400.275, F.S.;
  119         revising agency duties with regard to training nursing
  120         home surveyor teams; revising requirements for team
  121         members; amending s. 400.462, F.S.; redefining the
  122         term “remuneration” for purposes of the Home Health
  123         Services Act; amending s. 400.484, F.S.; revising the
  124         schedule of home health agency inspection violations;
  125         amending s. 400.506, F.S.; providing that a nurse
  126         registry is exempt from certain license penalties and
  127         fines otherwise imposed by the Agency for Health Care
  128         Administration on a nurse registry under certain
  129         circumstances; authorizing an administrator to manage
  130         up to five nurse registries under certain
  131         circumstances; requiring an administrator to
  132         designate, in writing, for each licensed entity, a
  133         qualified alternate administrator to serve during the
  134         administrator’s absence; amending s. 400.509, F.S.;
  135         providing that organizations that provide companion
  136         services only to persons with developmental
  137         disabilities, under contract with the Agency for
  138         Persons with Disabilities, are exempt from
  139         registration with the Agency for Health Care
  140         Administration; reenacting ss. 400.464(5)(b) and
  141         400.506(6)(a), F.S., relating to home health agencies
  142         and licensure of nurse registries, respectively, to
  143         incorporate the amendment made to s. 400.509, F.S., in
  144         references thereto; amending s. 400.606, F.S.;
  145         revising the content requirements of the plan
  146         accompanying an initial or change-of-ownership
  147         application for licensure of a hospice; revising
  148         requirements relating to certificates of need for
  149         certain hospice facilities; amending s. 400.607, F.S.;
  150         revising grounds for agency action against a hospice;
  151         amending s. 400.915, F.S.; correcting an obsolete
  152         cross-reference to administrative rules; amending s.
  153         400.931, F.S.; requiring each applicant for initial
  154         licensure, change of ownership, or renewal to operate
  155         a licensed home medical equipment provider at a
  156         location outside the state to submit documentation of
  157         accreditation, or an application for accreditation,
  158         from an accrediting organization that is recognized by
  159         the Agency for Health Care Administration; requiring
  160         an applicant that has applied for accreditation to
  161         provide proof of accreditation within a specified
  162         time; deleting a requirement that an applicant for a
  163         home medical equipment provider license submit a
  164         surety bond to the agency; amending s. 400.932, F.S.;
  165         revising grounds for the imposition of administrative
  166         penalties for certain violations by an employee of a
  167         home medical equipment provider; amending s. 400.967,
  168         F.S.; revising the schedule of inspection violations
  169         for intermediate care facilities for the
  170         developmentally disabled; providing a penalty for
  171         certain violations; amending s. 400.9905, F.S.;
  172         revising the definitions of the terms “clinic” and
  173         “portable equipment provider”; providing that part X
  174         of ch. 400, F.S., the Health Care Clinic Act, does not
  175         apply to certain clinical facilities, an entity owned
  176         by a corporation with a specified amount of annual
  177         sales of health care services under certain
  178         circumstances, an entity owned or controlled by a
  179         publicly traded entity with a specified amount of
  180         annual revenues, or an entity that employs at least a
  181         certain number of health care practitioners and bills
  182         for medical services under a single corporate tax
  183         identification number; amending s. 400.991, F.S.;
  184         conforming terminology; revising application
  185         requirements relating to documentation of financial
  186         ability to operate a mobile clinic; amending s.
  187         408.033, F.S.; providing that fees assessed on
  188         selected health care facilities and organizations may
  189         be collected prospectively at the time of licensure
  190         renewal and prorated for the licensing period;
  191         amending s. 408.034, F.S.; revising agency authority
  192         relating to licensing of intermediate care facilities
  193         for the developmentally disabled; amending s. 408.036,
  194         F.S.; deleting an exemption from certain certificate
  195         of-need review requirements for a hospice or a hospice
  196         inpatient facility; deleting a requirement that the
  197         agency submit a report to the Legislature providing
  198         information concerning the number of requests it
  199         receives for an exemption from certificate-of-need
  200         review; amending s. 408.037, F.S.; revising
  201         requirements for the financial information to be
  202         included in an application for a certificate of need;
  203         amending s. 408.043, F.S.; revising requirements for
  204         certain freestanding inpatient hospice care facilities
  205         to obtain a certificate of need; amending s. 408.061,
  206         F.S.; revising health care facility data reporting
  207         requirements; amending s. 408.10, F.S.; removing
  208         agency authority to investigate certain consumer
  209         complaints; amending s. 408.802, F.S.; removing
  210         applicability of part II of ch. 408, F.S., relating to
  211         general licensure requirements, to private review
  212         agents; amending s. 408.804, F.S.; providing penalties
  213         for altering, defacing, or falsifying a license
  214         certificate issued by the agency or displaying such an
  215         altered, defaced, or falsified certificate; amending
  216         s. 408.806, F.S.; revising agency responsibilities for
  217         notification of licensees of impending expiration of a
  218         license; requiring payment of a late fee for a license
  219         application to be considered complete under certain
  220         circumstances; amending s. 408.8065, F.S.; revising
  221         the requirements for becoming licensed as a home
  222         health agency, home medical equipment provider, or
  223         health care clinic; amending s. 408.809, F.S.;
  224         revising provisions to include a schedule for
  225         background rescreenings of certain employees; amending
  226         s. 408.813, F.S.; authorizing the agency to impose
  227         fines for unclassified violations of part II of ch.
  228         408, F.S.; amending s. 408.815, F.S.; authorizing the
  229         agency to extend a license expiration date under
  230         certain circumstances; amending s. 409.91196, F.S.;
  231         conforming a cross-reference; amending s. 409.912,
  232         F.S.; revising procedures for implementation of a
  233         Medicaid prescribed-drug spending-control program;
  234         amending s. 429.07, F.S.; deleting the requirement for
  235         an assisted living facility to obtain an additional
  236         license in order to provide limited nursing services;
  237         deleting the requirement for the agency to conduct
  238         quarterly monitoring visits of facilities that hold a
  239         license to provide extended congregate care services;
  240         deleting the requirement for the department to report
  241         annually on the status of and recommendations related
  242         to extended congregate care; deleting the requirement
  243         for the agency to conduct monitoring visits at least
  244         twice a year to facilities providing limited nursing
  245         services; increasing the additional licensing fee per
  246         resident based on the total licensed resident capacity
  247         of the facility; eliminating the license fee for the
  248         limited nursing services license; transferring from
  249         another provision of law the requirement that a
  250         biennial survey of an assisted living facility include
  251         specific actions to determine whether the facility is
  252         adequately protecting residents’ rights; providing
  253         that under specified conditions an assisted living
  254         facility that has a class I or class II violation is
  255         subject to periodic unannounced monitoring; requiring
  256         a registered nurse to participate in certain
  257         monitoring visits; amending s. 429.11, F.S.; revising
  258         licensure application requirements for assisted living
  259         facilities to eliminate provisional licenses; amending
  260         s. 429.12, F.S.; deleting a requirement that a
  261         transferor of an assisted living facility advise the
  262         transferee to submit a plan for correction of certain
  263         deficiencies to the Agency for Health Care
  264         Administration before ownership of the facility is
  265         transferred; amending s. 429.17, F.S.; deleting
  266         provisions relating to the limited nursing services
  267         license; revising agency responsibilities regarding
  268         the issuance of conditional licenses; amending s.
  269         429.195, F.S.; prohibiting an assisted living facility
  270         from contracting or promising to pay or receive any
  271         commission, bonus, kickback, or rebate or engage in
  272         any split-fee arrangement with any health care
  273         provider or health care facility; providing
  274         exceptions; amending s. 429.23, F.S.; deleting
  275         reporting requirements for assisted living facilities
  276         relating to liability claims; amending s. 429.255,
  277         F.S.; eliminating provisions authorizing the use of
  278         volunteers to provide certain health-care-related
  279         services in assisted living facilities; authorizing
  280         assisted living facilities to provide limited nursing
  281         services; requiring an assisted living facility to be
  282         responsible for certain recordkeeping and staff to be
  283         trained to monitor residents receiving certain health
  284         care-related services; amending s. 429.28, F.S.;
  285         deleting a requirement for a biennial survey of an
  286         assisted living facility, to conform to changes made
  287         by the act; conforming a cross-reference; amending s.
  288         429.294, F.S.; conforming provisions to changes made
  289         by the act; amending s. 429.41, F.S., relating to
  290         rulemaking; conforming provisions to changes made by
  291         the act; deleting the requirement for the Department
  292         of Elderly Affairs to submit to the Legislature a copy
  293         of proposed rules regarding the quality of resident
  294         care in an assisted living facility; amending s.
  295         429.53, F.S.; revising provisions relating to
  296         consultation by the agency; revising a definition;
  297         amending s. 429.54, F.S.; requiring licensed assisted
  298         living facilities to electronically report certain
  299         data semiannually to the agency in accordance with
  300         rules adopted by the department; amending s. 429.71,
  301         F.S.; revising schedule of inspection violations for
  302         adult family-care homes; amending s. 429.915, F.S.;
  303         revising agency responsibilities regarding the
  304         issuance of conditional licenses; repealing s.
  305         440.102(9)(d), F.S., relating to a laboratory’s
  306         requirement to submit to the Agency for Health Care
  307         Administration a monthly report containing statistical
  308         information regarding the testing of employees and job
  309         applicants; amending s. 483.035, F.S.; providing for a
  310         clinical laboratory to be operated by certain nurses;
  311         amending s. 483.051, F.S.; requiring the Agency for
  312         Health Care Administration to provide for biennial
  313         licensure of all nonwaived laboratories that meet
  314         certain requirements; requiring the agency to
  315         prescribe qualifications for such licensure; defining
  316         nonwaived laboratories as laboratories that do not
  317         have a certificate of waiver from the Centers for
  318         Medicare and Medicaid Services; deleting requirements
  319         for the registration of an alternate site testing
  320         location when the clinical laboratory applies to renew
  321         its license; amending s. 483.294, F.S.; revising
  322         frequency of agency inspections of multiphasic health
  323         testing centers; amending s. 626.9541, F.S.;
  324         authorizing an insurer offering a group or individual
  325         health benefit plan to offer a wellness program;
  326         authorizing rewards or incentives; providing for
  327         verification of a member’s inability to participate
  328         for medical reasons; providing that such rewards or
  329         incentives are not insurance benefits; amending s.
  330         766.202, F.S.; adding persons licensed under part XIV
  331         of ch. 468, F.S., to the definition of “health care
  332         provider”; amending ss. 394.4787, 400.0239, 408.07,
  333         430.80, and 651.118, F.S.; conforming terminology and
  334         references to changes made by the act; revising a
  335         reference; amending s. 817.505, F.S.; providing that
  336         it is not patient brokering for an assisted living
  337         facility to offer payment under certain circumstances;
  338         amending s. 381.06014, F.S.; redefining the term
  339         “blood establishment” and defining the term “volunteer
  340         donor”; prohibiting local governments from restricting
  341         access to public facilities or infrastructure for
  342         certain activities based on whether a blood
  343         establishment is operating as a for-profit
  344         organization or not-for-profit organization;
  345         prohibiting a blood establishment from considering
  346         whether certain customers are operating as for-profit
  347         organizations or not-for-profit organizations when
  348         determining service fees for selling blood or blood
  349         components; requiring that certain blood
  350         establishments disclose specified information on the
  351         Internet; authorizing the Department of Legal Affairs
  352         to assess a civil penalty against a blood
  353         establishment that fails to disclose specified
  354         information on the Internet; providing that the civil
  355         penalty accrues to the state and requiring that it be
  356         deposited as received into the General Revenue Fund;
  357         amending s. 499.003, F.S.; redefining the term “health
  358         care entity” to clarify that a blood establishment is
  359         a health care entity that may engage in certain
  360         activities; amending s. 499.005, F.S.; clarifying
  361         provisions that prohibit the unauthorized wholesale
  362         distribution of a prescription drug that was purchased
  363         by a hospital or other health care entity or donated
  364         or supplied at a reduced price to a charitable
  365         organization, to conform to changes made by the act;
  366         amending s. 499.01, F.S.; exempting certain blood
  367         establishments from the requirements to be permitted
  368         as a prescription drug manufacturer and register
  369         products; requiring that certain blood establishments
  370         obtain a restricted prescription drug distributor
  371         permit under specified conditions; limiting the
  372         prescription drugs that a blood establishment may
  373         distribute under a restricted prescription drug
  374         distributor permit; authorizing the Department of
  375         Health to adopt rules regarding the distribution of
  376         prescription drugs by blood establishments; providing
  377         an effective date.
  378  
  379  Be It Enacted by the Legislature of the State of Florida:
  380  
  381         Section 1. Subsection (1) of section 83.42, Florida
  382  Statutes, is amended to read:
  383         83.42 Exclusions from application of part.—This part does
  384  not apply to:
  385         (1) Residency or detention in a facility, whether public or
  386  private, when residence or detention is incidental to the
  387  provision of medical, geriatric, educational, counseling,
  388  religious, or similar services. The procedures for all transfers
  389  and discharges as provided in s. 400.0255 apply only to
  390  residents of a facility licensed under part II of chapter 400.
  391         Section 2. Present paragraphs (f) through (k) of subsection
  392  (10) of section 112.0455, Florida Statutes, are redesignated as
  393  paragraphs (e) through (j), respectively, and present paragraph
  394  (e) of subsection (10), subsection (12), and paragraph (e) of
  395  subsection (14) of that section are amended to read:
  396         112.0455 Drug-Free Workplace Act.—
  397         (10) EMPLOYER PROTECTION.—
  398         (e) Nothing in this section shall be construed to operate
  399  retroactively, and nothing in this section shall abrogate the
  400  right of an employer under state law to conduct drug tests prior
  401  to January 1, 1990. A drug test conducted by an employer prior
  402  to January 1, 1990, is not subject to this section.
  403         (12) DRUG-TESTING STANDARDS; LABORATORIES.—
  404         (a) The requirements of part II of chapter 408 apply to the
  405  provision of services that require licensure pursuant to this
  406  section and part II of chapter 408 and to entities licensed by
  407  or applying for such licensure from the Agency for Health Care
  408  Administration pursuant to this section. A license issued by the
  409  agency is required in order to operate a laboratory.
  410         (b) A laboratory may analyze initial or confirmation drug
  411  specimens only if:
  412         1. The laboratory is licensed and approved by the Agency
  413  for Health Care Administration using criteria established by the
  414  United States Department of Health and Human Services as general
  415  guidelines for modeling the state drug testing program and in
  416  accordance with part II of chapter 408. Each applicant for
  417  licensure and licensee must comply with all requirements of part
  418  II of chapter 408.
  419         2. The laboratory has written procedures to ensure chain of
  420  custody.
  421         3. The laboratory follows proper quality control
  422  procedures, including, but not limited to:
  423         a. The use of internal quality controls including the use
  424  of samples of known concentrations which are used to check the
  425  performance and calibration of testing equipment, and periodic
  426  use of blind samples for overall accuracy.
  427         b. An internal review and certification process for drug
  428  test results, conducted by a person qualified to perform that
  429  function in the testing laboratory.
  430         c. Security measures implemented by the testing laboratory
  431  to preclude adulteration of specimens and drug test results.
  432         d. Other necessary and proper actions taken to ensure
  433  reliable and accurate drug test results.
  434         (c) A laboratory shall disclose to the employer a written
  435  test result report within 7 working days after receipt of the
  436  sample. All laboratory reports of a drug test result shall, at a
  437  minimum, state:
  438         1. The name and address of the laboratory which performed
  439  the test and the positive identification of the person tested.
  440         2. Positive results on confirmation tests only, or negative
  441  results, as applicable.
  442         3. A list of the drugs for which the drug analyses were
  443  conducted.
  444         4. The type of tests conducted for both initial and
  445  confirmation tests and the minimum cutoff levels of the tests.
  446         5. Any correlation between medication reported by the
  447  employee or job applicant pursuant to subparagraph (8)(b)2. and
  448  a positive confirmed drug test result.
  449  
  450  No report shall disclose the presence or absence of any drug
  451  other than a specific drug and its metabolites listed pursuant
  452  to this section.
  453         (d) The laboratory shall submit to the Agency for Health
  454  Care Administration a monthly report with statistical
  455  information regarding the testing of employees and job
  456  applicants. The reports shall include information on the methods
  457  of analyses conducted, the drugs tested for, the number of
  458  positive and negative results for both initial and confirmation
  459  tests, and any other information deemed appropriate by the
  460  Agency for Health Care Administration. No monthly report shall
  461  identify specific employees or job applicants.
  462         (d)(e) Laboratories shall provide technical assistance to
  463  the employer, employee, or job applicant for the purpose of
  464  interpreting any positive confirmed test results which could
  465  have been caused by prescription or nonprescription medication
  466  taken by the employee or job applicant.
  467         (14) DISCIPLINE REMEDIES.—
  468         (e) Upon resolving an appeal filed pursuant to paragraph
  469  (c), and finding a violation of this section, the commission may
  470  order the following relief:
  471         1. Rescind the disciplinary action, expunge related records
  472  from the personnel file of the employee or job applicant and
  473  reinstate the employee.
  474         2. Order compliance with paragraph (10)(f)(g).
  475         3. Award back pay and benefits.
  476         4. Award the prevailing employee or job applicant the
  477  necessary costs of the appeal, reasonable attorney’s fees, and
  478  expert witness fees.
  479         Section 3. Paragraph (n) of subsection (1) of section
  480  154.11, Florida Statutes, is amended to read:
  481         154.11 Powers of board of trustees.—
  482         (1) The board of trustees of each public health trust shall
  483  be deemed to exercise a public and essential governmental
  484  function of both the state and the county and in furtherance
  485  thereof it shall, subject to limitation by the governing body of
  486  the county in which such board is located, have all of the
  487  powers necessary or convenient to carry out the operation and
  488  governance of designated health care facilities, including, but
  489  without limiting the generality of, the foregoing:
  490         (n) To appoint originally the staff of physicians to
  491  practice in any designated facility owned or operated by the
  492  board and to approve the bylaws and rules to be adopted by the
  493  medical staff of any designated facility owned and operated by
  494  the board, such governing regulations to be in accordance with
  495  the standards of the Joint Commission on the Accreditation of
  496  Hospitals which provide, among other things, for the method of
  497  appointing additional staff members and for the removal of staff
  498  members.
  499         Section 4. Section 383.325, Florida Statutes, is repealed.
  500         Section 5. Subsection (7) of section 394.4787, Florida
  501  Statutes, is amended to read:
  502         394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and
  503  394.4789.—As used in this section and ss. 394.4786, 394.4788,
  504  and 394.4789:
  505         (7) “Specialty psychiatric hospital” means a hospital
  506  licensed by the agency pursuant to s. 395.002(26)(28) and part
  507  II of chapter 408 as a specialty psychiatric hospital.
  508         Section 6. Subsection (2) of section 394.741, Florida
  509  Statutes, is amended to read:
  510         394.741 Accreditation requirements for providers of
  511  behavioral health care services.—
  512         (2) Notwithstanding any provision of law to the contrary,
  513  accreditation shall be accepted by the agency and department in
  514  lieu of the agency’s and department’s facility licensure onsite
  515  review requirements and shall be accepted as a substitute for
  516  the department’s administrative and program monitoring
  517  requirements, except as required by subsections (3) and (4),
  518  for:
  519         (a) Any organization from which the department purchases
  520  behavioral health care services that is accredited by the Joint
  521  Commission on Accreditation of Healthcare Organizations or the
  522  Council on Accreditation for Children and Family Services, or
  523  has those services that are being purchased by the department
  524  accredited by the Commission on Accreditation of Rehabilitation
  525  Facilities CARF—the Rehabilitation Accreditation Commission.
  526         (b) Any mental health facility licensed by the agency or
  527  any substance abuse component licensed by the department that is
  528  accredited by the Joint Commission on Accreditation of
  529  Healthcare Organizations, the Commission on Accreditation of
  530  Rehabilitation Facilities CARF—the Rehabilitation Accreditation
  531  Commission, or the Council on Accreditation of Children and
  532  Family Services.
  533         (c) Any network of providers from which the department or
  534  the agency purchases behavioral health care services accredited
  535  by the Joint Commission on Accreditation of Healthcare
  536  Organizations, the Commission on Accreditation of Rehabilitation
  537  Facilities CARF—the Rehabilitation Accreditation Commission, the
  538  Council on Accreditation of Children and Family Services, or the
  539  National Committee for Quality Assurance. A provider
  540  organization, which is part of an accredited network, is
  541  afforded the same rights under this part.
  542         Section 7. Present subsections (15) through (32) of section
  543  395.002, Florida Statutes, are renumbered as subsections (14)
  544  through (28), respectively, and present subsections (1), (14),
  545  (24), (30), and (31) and paragraph (c) of present subsection
  546  (28) of that section are amended to read:
  547         395.002 Definitions.—As used in this chapter:
  548         (1) “Accrediting organizations” means nationally recognized
  549  or approved accrediting organizations whose standards
  550  incorporate comparable licensure requirements as determined by
  551  the agency the Joint Commission on Accreditation of Healthcare
  552  Organizations, the American Osteopathic Association, the
  553  Commission on Accreditation of Rehabilitation Facilities, and
  554  the Accreditation Association for Ambulatory Health Care, Inc.
  555         (14) “Initial denial determination” means a determination
  556  by a private review agent that the health care services
  557  furnished or proposed to be furnished to a patient are
  558  inappropriate, not medically necessary, or not reasonable.
  559         (24) “Private review agent” means any person or entity
  560  which performs utilization review services for third-party
  561  payors on a contractual basis for outpatient or inpatient
  562  services. However, the term shall not include full-time
  563  employees, personnel, or staff of health insurers, health
  564  maintenance organizations, or hospitals, or wholly owned
  565  subsidiaries thereof or affiliates under common ownership, when
  566  performing utilization review for their respective hospitals,
  567  health maintenance organizations, or insureds of the same
  568  insurance group. For this purpose, health insurers, health
  569  maintenance organizations, and hospitals, or wholly owned
  570  subsidiaries thereof or affiliates under common ownership,
  571  include such entities engaged as administrators of self
  572  insurance as defined in s. 624.031.
  573         (26)(28) “Specialty hospital” means any facility which
  574  meets the provisions of subsection (12), and which regularly
  575  makes available either:
  576         (c) Intensive residential treatment programs for children
  577  and adolescents as defined in subsection (14) (15).
  578         (30) “Utilization review” means a system for reviewing the
  579  medical necessity or appropriateness in the allocation of health
  580  care resources of hospital services given or proposed to be
  581  given to a patient or group of patients.
  582         (31) “Utilization review plan” means a description of the
  583  policies and procedures governing utilization review activities
  584  performed by a private review agent.
  585         Section 8. Paragraph (c) of subsection (1) and paragraph
  586  (b) of subsection (2) of section 395.003, Florida Statutes, are
  587  amended to read:
  588         395.003 Licensure; denial, suspension, and revocation.—
  589         (1)
  590         (c) Until July 1, 2006, additional emergency departments
  591  located off the premises of licensed hospitals may not be
  592  authorized by the agency.
  593         (2)
  594         (b) The agency shall, at the request of a licensee that is
  595  a teaching hospital as defined in s. 408.07(45), issue a single
  596  license to a licensee for facilities that have been previously
  597  licensed as separate premises, provided such separately licensed
  598  facilities, taken together, constitute the same premises as
  599  defined in s. 395.002(22)(23). Such license for the single
  600  premises shall include all of the beds, services, and programs
  601  that were previously included on the licenses for the separate
  602  premises. The granting of a single license under this paragraph
  603  shall not in any manner reduce the number of beds, services, or
  604  programs operated by the licensee.
  605         Section 9. Subsection (3) of section 395.0161, Florida
  606  Statutes, is amended to read:
  607         395.0161 Licensure inspection.—
  608         (3) In accordance with s. 408.805, an applicant or licensee
  609  shall pay a fee for each license application submitted under
  610  this part, part II of chapter 408, and applicable rules. With
  611  the exception of state-operated licensed facilities, each
  612  facility licensed under this part shall pay to the agency, at
  613  the time of inspection, the following fees:
  614         (a) Inspection for licensure.—A fee shall be paid which is
  615  not less than $8 per hospital bed, nor more than $12 per
  616  hospital bed, except that the minimum fee shall be $400 per
  617  facility.
  618         (b) Inspection for lifesafety only.—A fee shall be paid
  619  which is not less than 75 cents per hospital bed, nor more than
  620  $1.50 per hospital bed, except that the minimum fee shall be $40
  621  per facility.
  622         Section 10. Paragraph (e) of subsection (2) and subsection
  623  (4) of section 395.0193, Florida Statutes, are amended to read:
  624         395.0193 Licensed facilities; peer review; disciplinary
  625  powers; agency or partnership with physicians.—
  626         (2) Each licensed facility, as a condition of licensure,
  627  shall provide for peer review of physicians who deliver health
  628  care services at the facility. Each licensed facility shall
  629  develop written, binding procedures by which such peer review
  630  shall be conducted. Such procedures shall include:
  631         (e) Recording of agendas and minutes which do not contain
  632  confidential material, for review by the Division of Medical
  633  Quality Assurance of the department Health Quality Assurance of
  634  the agency.
  635         (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
  636  actions taken under subsection (3) shall be reported in writing
  637  to the Division of Medical Quality Assurance of the department
  638  Health Quality Assurance of the agency within 30 working days
  639  after its initial occurrence, regardless of the pendency of
  640  appeals to the governing board of the hospital. The notification
  641  shall identify the disciplined practitioner, the action taken,
  642  and the reason for such action. All final disciplinary actions
  643  taken under subsection (3), if different from those which were
  644  reported to the department agency within 30 days after the
  645  initial occurrence, shall be reported within 10 working days to
  646  the Division of Medical Quality Assurance of the department
  647  Health Quality Assurance of the agency in writing and shall
  648  specify the disciplinary action taken and the specific grounds
  649  therefor. The division shall review each report and determine
  650  whether it potentially involved conduct by the licensee that is
  651  subject to disciplinary action, in which case s. 456.073 shall
  652  apply. The reports are not subject to inspection under s.
  653  119.07(1) even if the division’s investigation results in a
  654  finding of probable cause.
  655         Section 11. Section 395.1023, Florida Statutes, is amended
  656  to read:
  657         395.1023 Child abuse and neglect cases; duties.—Each
  658  licensed facility shall adopt a protocol that, at a minimum,
  659  requires the facility to:
  660         (1) Incorporate a facility policy that every staff member
  661  has an affirmative duty to report, pursuant to chapter 39, any
  662  actual or suspected case of child abuse, abandonment, or
  663  neglect; and
  664         (2) In any case involving suspected child abuse,
  665  abandonment, or neglect, designate, at the request of the
  666  Department of Children and Family Services, a staff physician to
  667  act as a liaison between the hospital and the Department of
  668  Children and Family Services office which is investigating the
  669  suspected abuse, abandonment, or neglect, and the child
  670  protection team, as defined in s. 39.01, when the case is
  671  referred to such a team.
  672  
  673  Each general hospital and appropriate specialty hospital shall
  674  comply with the provisions of this section and shall notify the
  675  agency and the Department of Children and Family Services of its
  676  compliance by sending a copy of its policy to the agency and the
  677  Department of Children and Family Services as required by rule.
  678  The failure by a general hospital or appropriate specialty
  679  hospital to comply shall be punished by a fine not exceeding
  680  $1,000, to be fixed, imposed, and collected by the agency. Each
  681  day in violation is considered a separate offense.
  682         Section 12. Subsection (2) and paragraph (d) of subsection
  683  (3) of section 395.1041, Florida Statutes, are amended to read:
  684         395.1041 Access to emergency services and care.—
  685         (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
  686  shall establish and maintain an inventory of hospitals with
  687  emergency services. The inventory shall list all services within
  688  the service capability of the hospital, and such services shall
  689  appear on the face of the hospital license. Each hospital having
  690  emergency services shall notify the agency of its service
  691  capability in the manner and form prescribed by the agency. The
  692  agency shall use the inventory to assist emergency medical
  693  services providers and others in locating appropriate emergency
  694  medical care. The inventory shall also be made available to the
  695  general public. On or before August 1, 1992, the agency shall
  696  request that each hospital identify the services which are
  697  within its service capability. On or before November 1, 1992,
  698  the agency shall notify each hospital of the service capability
  699  to be included in the inventory. The hospital has 15 days from
  700  the date of receipt to respond to the notice. By December 1,
  701  1992, the agency shall publish a final inventory. Each hospital
  702  shall reaffirm its service capability when its license is
  703  renewed and shall notify the agency of the addition of a new
  704  service or the termination of a service prior to a change in its
  705  service capability.
  706         (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
  707  FACILITY OR HEALTH CARE PERSONNEL.—
  708         (d)1. Every hospital shall ensure the provision of services
  709  within the service capability of the hospital, at all times,
  710  either directly or indirectly through an arrangement with
  711  another hospital, through an arrangement with one or more
  712  physicians, or as otherwise made through prior arrangements. A
  713  hospital may enter into an agreement with another hospital for
  714  purposes of meeting its service capability requirement, and
  715  appropriate compensation or other reasonable conditions may be
  716  negotiated for these backup services.
  717         2. If any arrangement requires the provision of emergency
  718  medical transportation, such arrangement must be made in
  719  consultation with the applicable provider and may not require
  720  the emergency medical service provider to provide transportation
  721  that is outside the routine service area of that provider or in
  722  a manner that impairs the ability of the emergency medical
  723  service provider to timely respond to prehospital emergency
  724  calls.
  725         3. A hospital shall not be required to ensure service
  726  capability at all times as required in subparagraph 1. if, prior
  727  to the receiving of any patient needing such service capability,
  728  such hospital has demonstrated to the agency that it lacks the
  729  ability to ensure such capability and it has exhausted all
  730  reasonable efforts to ensure such capability through backup
  731  arrangements. In reviewing a hospital’s demonstration of lack of
  732  ability to ensure service capability, the agency shall consider
  733  factors relevant to the particular case, including the
  734  following:
  735         a. Number and proximity of hospitals with the same service
  736  capability.
  737         b. Number, type, credentials, and privileges of
  738  specialists.
  739         c. Frequency of procedures.
  740         d. Size of hospital.
  741         4. The agency shall publish proposed rules implementing a
  742  reasonable exemption procedure by November 1, 1992. Subparagraph
  743  1. shall become effective upon the effective date of said rules
  744  or January 31, 1993, whichever is earlier. For a period not to
  745  exceed 1 year from the effective date of subparagraph 1., a
  746  hospital requesting an exemption shall be deemed to be exempt
  747  from offering the service until the agency initially acts to
  748  deny or grant the original request. The agency has 45 days after
  749  from the date of receipt of the request to approve or deny the
  750  request. After the first year from the effective date of
  751  subparagraph 1., If the agency fails to initially act within
  752  that the time period, the hospital is deemed to be exempt from
  753  offering the service until the agency initially acts to deny the
  754  request.
  755         Section 13. Section 395.1046, Florida Statutes, is
  756  repealed.
  757         Section 14. Paragraph (e) of subsection (1) of section
  758  395.1055, Florida Statutes, is amended to read:
  759         395.1055 Rules and enforcement.—
  760         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
  761  and 120.54 to implement the provisions of this part, which shall
  762  include reasonable and fair minimum standards for ensuring that:
  763         (e) Licensed facility beds conform to minimum space,
  764  equipment, and furnishings standards as specified by the agency,
  765  the Florida Building Code, and the Florida Fire Prevention Code
  766  department.
  767         Section 15. Subsection (1) of section 395.10972, Florida
  768  Statutes, is amended to read:
  769         395.10972 Health Care Risk Manager Advisory Council.—The
  770  Secretary of Health Care Administration may appoint a seven
  771  member advisory council to advise the agency on matters
  772  pertaining to health care risk managers. The members of the
  773  council shall serve at the pleasure of the secretary. The
  774  council shall designate a chair. The council shall meet at the
  775  call of the secretary or at those times as may be required by
  776  rule of the agency. The members of the advisory council shall
  777  receive no compensation for their services, but shall be
  778  reimbursed for travel expenses as provided in s. 112.061. The
  779  council shall consist of individuals representing the following
  780  areas:
  781         (1) Two shall be active health care risk managers,
  782  including one risk manager who is recommended by and a member of
  783  the Florida Society for of Healthcare Risk Management and
  784  Patient Safety.
  785         Section 16. Subsection (3) of section 395.2050, Florida
  786  Statutes, is amended to read:
  787         395.2050 Routine inquiry for organ and tissue donation;
  788  certification for procurement activities; death records review.—
  789         (3) Each organ procurement organization designated by the
  790  federal Centers for Medicare and Medicaid Services Health Care
  791  Financing Administration and licensed by the state shall conduct
  792  an annual death records review in the organ procurement
  793  organization’s affiliated donor hospitals. The organ procurement
  794  organization shall enlist the services of every Florida licensed
  795  tissue bank and eye bank affiliated with or providing service to
  796  the donor hospital and operating in the same service area to
  797  participate in the death records review.
  798         Section 17. Subsection (2) of section 395.3036, Florida
  799  Statutes, is amended to read:
  800         395.3036 Confidentiality of records and meetings of
  801  corporations that lease public hospitals or other public health
  802  care facilities.—The records of a private corporation that
  803  leases a public hospital or other public health care facility
  804  are confidential and exempt from the provisions of s. 119.07(1)
  805  and s. 24(a), Art. I of the State Constitution, and the meetings
  806  of the governing board of a private corporation are exempt from
  807  s. 286.011 and s. 24(b), Art. I of the State Constitution when
  808  the public lessor complies with the public finance
  809  accountability provisions of s. 155.40(5) with respect to the
  810  transfer of any public funds to the private lessee and when the
  811  private lessee meets at least three of the five following
  812  criteria:
  813         (2) The public lessor and the private lessee do not
  814  commingle any of their funds in any account maintained by either
  815  of them, other than the payment of the rent and administrative
  816  fees or the transfer of funds pursuant to s. 155.40 subsection
  817  (2).
  818         Section 18. Section 395.3037, Florida Statutes, is
  819  repealed.
  820         Section 19. Subsections (1), (4), and (5) of section
  821  395.3038, Florida Statutes, are amended to read:
  822         395.3038 State-listed primary stroke centers and
  823  comprehensive stroke centers; notification of hospitals.—
  824         (1) The agency shall make available on its website and to
  825  the department a list of the name and address of each hospital
  826  that meets the criteria for a primary stroke center and the name
  827  and address of each hospital that meets the criteria for a
  828  comprehensive stroke center. The list of primary and
  829  comprehensive stroke centers shall include only those hospitals
  830  that attest in an affidavit submitted to the agency that the
  831  hospital meets the named criteria, or those hospitals that
  832  attest in an affidavit submitted to the agency that the hospital
  833  is certified as a primary or a comprehensive stroke center by
  834  the Joint Commission on Accreditation of Healthcare
  835  Organizations.
  836         (4) The agency shall adopt by rule criteria for a primary
  837  stroke center which are substantially similar to the
  838  certification standards for primary stroke centers of the Joint
  839  Commission on Accreditation of Healthcare Organizations.
  840         (5) The agency shall adopt by rule criteria for a
  841  comprehensive stroke center. However, if the Joint Commission on
  842  Accreditation of Healthcare Organizations establishes criteria
  843  for a comprehensive stroke center, the agency shall establish
  844  criteria for a comprehensive stroke center which are
  845  substantially similar to those criteria established by the Joint
  846  Commission on Accreditation of Healthcare Organizations.
  847         Section 20. Paragraph (e) of subsection (2) of section
  848  395.602, Florida Statutes, is amended to read:
  849         395.602 Rural hospitals.—
  850         (2) DEFINITIONS.—As used in this part:
  851         (e) “Rural hospital” means an acute care hospital licensed
  852  under this chapter, having 100 or fewer licensed beds and an
  853  emergency room, which is:
  854         1. The sole provider within a county with a population
  855  density of no greater than 100 persons per square mile;
  856         2. An acute care hospital, in a county with a population
  857  density of no greater than 100 persons per square mile, which is
  858  at least 30 minutes of travel time, on normally traveled roads
  859  under normal traffic conditions, from any other acute care
  860  hospital within the same county;
  861         3. A hospital supported by a tax district or subdistrict
  862  whose boundaries encompass a population of 100 persons or fewer
  863  per square mile;
  864         4. A hospital in a constitutional charter county with a
  865  population of over 1 million persons that has imposed a local
  866  option health service tax pursuant to law and in an area that
  867  was directly impacted by a catastrophic event on August 24,
  868  1992, for which the Governor of Florida declared a state of
  869  emergency pursuant to chapter 125, and has 120 beds or less that
  870  serves an agricultural community with an emergency room
  871  utilization of no less than 20,000 visits and a Medicaid
  872  inpatient utilization rate greater than 15 percent;
  873         4.5. A hospital with a service area that has a population
  874  of 100 persons or fewer per square mile. As used in this
  875  subparagraph, the term “service area” means the fewest number of
  876  zip codes that account for 75 percent of the hospital’s
  877  discharges for the most recent 5-year period, based on
  878  information available from the hospital inpatient discharge
  879  database in the Florida Center for Health Information and Policy
  880  Analysis at the Agency for Health Care Administration; or
  881         5.6. A hospital designated as a critical access hospital,
  882  as defined in s. 408.07(15).
  883  
  884  Population densities used in this paragraph must be based upon
  885  the most recently completed United States census. A hospital
  886  that received funds under s. 409.9116 for a quarter beginning no
  887  later than July 1, 2002, is deemed to have been and shall
  888  continue to be a rural hospital from that date through June 30,
  889  2015, if the hospital continues to have 100 or fewer licensed
  890  beds and an emergency room, or meets the criteria of
  891  subparagraph 4. An acute care hospital that has not previously
  892  been designated as a rural hospital and that meets the criteria
  893  of this paragraph shall be granted such designation upon
  894  application, including supporting documentation to the Agency
  895  for Health Care Administration.
  896         Section 21. Subsections (8) and (16) of section 400.021,
  897  Florida Statutes, are amended to read:
  898         400.021 Definitions.—When used in this part, unless the
  899  context otherwise requires, the term:
  900         (8) “Geriatric outpatient clinic” means a site for
  901  providing outpatient health care to persons 60 years of age or
  902  older, which is staffed by a registered nurse or a physician
  903  assistant, or a licensed practical nurse under the direct
  904  supervision of a registered nurse, advanced registered nurse
  905  practitioner, or physician.
  906         (16) “Resident care plan” means a written plan developed,
  907  maintained, and reviewed not less than quarterly by a registered
  908  nurse, with participation from other facility staff and the
  909  resident or his or her designee or legal representative, which
  910  includes a comprehensive assessment of the needs of an
  911  individual resident; the type and frequency of services required
  912  to provide the necessary care for the resident to attain or
  913  maintain the highest practicable physical, mental, and
  914  psychosocial well-being; a listing of services provided within
  915  or outside the facility to meet those needs; and an explanation
  916  of service goals. The resident care plan must be signed by the
  917  director of nursing or another registered nurse employed by the
  918  facility to whom institutional responsibilities have been
  919  delegated and by the resident, the resident’s designee, or the
  920  resident’s legal representative. The facility may not use an
  921  agency or temporary registered nurse to satisfy the foregoing
  922  requirement and must document the institutional responsibilities
  923  that have been delegated to the registered nurse.
  924         Section 22. Subsection (1) of section 400.0234, Florida
  925  Statutes, is amended to read:
  926         400.0234 Availability of facility records for investigation
  927  of resident’s rights violations and defenses; penalty.—
  928         (1) Failure to provide complete copies of a resident’s
  929  records, including, but not limited to, all medical records and
  930  the resident’s chart, within the control or possession of the
  931  facility constitutes in accordance with s. 400.145 shall
  932  constitute evidence of failure of that party to comply with good
  933  faith discovery requirements and waives shall waive the good
  934  faith certificate and presuit notice requirements under this
  935  part by the requesting party.
  936         Section 23. Paragraph (g) of subsection (2) of section
  937  400.0239, Florida Statutes, is amended to read:
  938         400.0239 Quality of Long-Term Care Facility Improvement
  939  Trust Fund.—
  940         (2) Expenditures from the trust fund shall be allowable for
  941  direct support of the following:
  942         (g) Other initiatives authorized by the Centers for
  943  Medicare and Medicaid Services for the use of federal civil
  944  monetary penalties, including projects recommended through the
  945  Medicaid “Up-or-Out” Quality of Care Contract Management Program
  946  pursuant to s. 400.148.
  947         Section 24. Subsection (15) of section 400.0255, Florida
  948  Statutes, is amended to read
  949         400.0255 Resident transfer or discharge; requirements and
  950  procedures; hearings.—
  951         (15)(a) The department’s Office of Appeals Hearings shall
  952  conduct hearings under this section. The office shall notify the
  953  facility of a resident’s request for a hearing.
  954         (b) The department shall, by rule, establish procedures to
  955  be used for fair hearings requested by residents. These
  956  procedures shall be equivalent to the procedures used for fair
  957  hearings for other Medicaid cases appearing in s. 409.285 and
  958  applicable rules, chapter 10-2, part VI, Florida Administrative
  959  Code. The burden of proof must be clear and convincing evidence.
  960  A hearing decision must be rendered within 90 days after receipt
  961  of the request for hearing.
  962         (c) If the hearing decision is favorable to the resident
  963  who has been transferred or discharged, the resident must be
  964  readmitted to the facility’s first available bed.
  965         (d) The decision of the hearing officer shall be final. Any
  966  aggrieved party may appeal the decision to the district court of
  967  appeal in the appellate district where the facility is located.
  968  Review procedures shall be conducted in accordance with the
  969  Florida Rules of Appellate Procedure.
  970         Section 25. Subsection (2) of section 400.063, Florida
  971  Statutes, is amended to read:
  972         400.063 Resident protection.—
  973         (2) The agency is authorized to establish for each
  974  facility, subject to intervention by the agency, a separate bank
  975  account for the deposit to the credit of the agency of any
  976  moneys received from the Health Care Trust Fund or any other
  977  moneys received for the maintenance and care of residents in the
  978  facility, and the agency is authorized to disburse moneys from
  979  such account to pay obligations incurred for the purposes of
  980  this section. The agency is authorized to requisition moneys
  981  from the Health Care Trust Fund in advance of an actual need for
  982  cash on the basis of an estimate by the agency of moneys to be
  983  spent under the authority of this section. Any bank account
  984  established under this section need not be approved in advance
  985  of its creation as required by s. 17.58, but shall be secured by
  986  depository insurance equal to or greater than the balance of
  987  such account or by the pledge of collateral security in
  988  conformance with criteria established in s. 18.11. The agency
  989  shall notify the Chief Financial Officer of any such account so
  990  established and shall make a quarterly accounting to the Chief
  991  Financial Officer for all moneys deposited in such account.
  992         Section 26. Subsections (1) and (5) of section 400.071,
  993  Florida Statutes, are amended to read:
  994         400.071 Application for license.—
  995         (1) In addition to the requirements of part II of chapter
  996  408, the application for a license shall be under oath and must
  997  contain the following:
  998         (a) The location of the facility for which a license is
  999  sought and an indication, as in the original application, that
 1000  such location conforms to the local zoning ordinances.
 1001         (b) A signed affidavit disclosing any financial or
 1002  ownership interest that a controlling interest as defined in
 1003  part II of chapter 408 has held in the last 5 years in any
 1004  entity licensed by this state or any other state to provide
 1005  health or residential care which has closed voluntarily or
 1006  involuntarily; has filed for bankruptcy; has had a receiver
 1007  appointed; has had a license denied, suspended, or revoked; or
 1008  has had an injunction issued against it which was initiated by a
 1009  regulatory agency. The affidavit must disclose the reason any
 1010  such entity was closed, whether voluntarily or involuntarily.
 1011         (c) The total number of beds and the total number of
 1012  Medicare and Medicaid certified beds.
 1013         (b)(d) Information relating to the applicant and employees
 1014  which the agency requires by rule. The applicant must
 1015  demonstrate that sufficient numbers of qualified staff, by
 1016  training or experience, will be employed to properly care for
 1017  the type and number of residents who will reside in the
 1018  facility.
 1019         (e) Copies of any civil verdict or judgment involving the
 1020  applicant rendered within the 10 years preceding the
 1021  application, relating to medical negligence, violation of
 1022  residents’ rights, or wrongful death. As a condition of
 1023  licensure, the licensee agrees to provide to the agency copies
 1024  of any new verdict or judgment involving the applicant, relating
 1025  to such matters, within 30 days after filing with the clerk of
 1026  the court. The information required in this paragraph shall be
 1027  maintained in the facility’s licensure file and in an agency
 1028  database which is available as a public record.
 1029         (5) As a condition of licensure, each facility must
 1030  establish and submit with its application a plan for quality
 1031  assurance and for conducting risk management.
 1032         Section 27. Section 400.0712, Florida Statutes, is amended
 1033  to read:
 1034         400.0712 Application for inactive license.—
 1035         (1) As specified in this section, the agency may issue an
 1036  inactive license to a nursing home facility for all or a portion
 1037  of its beds. Any request by a licensee that a nursing home or
 1038  portion of a nursing home become inactive must be submitted to
 1039  the agency in the approved format. The facility may not initiate
 1040  any suspension of services, notify residents, or initiate
 1041  inactivity before receiving approval from the agency; and a
 1042  licensee that violates this provision may not be issued an
 1043  inactive license.
 1044         (1)(2)In addition to the powers granted under part II of
 1045  chapter 408, the agency may issue an inactive license for a
 1046  portion of the total beds to a nursing home that chooses to use
 1047  an unoccupied contiguous portion of the facility for an
 1048  alternative use to meet the needs of elderly persons through the
 1049  use of less restrictive, less institutional services.
 1050         (a) An inactive license issued under this subsection may be
 1051  granted for a period not to exceed the current licensure
 1052  expiration date but may be renewed by the agency at the time of
 1053  licensure renewal.
 1054         (b) A request to extend the inactive license must be
 1055  submitted to the agency in the approved format and approved by
 1056  the agency in writing.
 1057         (c) Nursing homes that receive an inactive license to
 1058  provide alternative services shall not receive preference for
 1059  participation in the Assisted Living for the Elderly Medicaid
 1060  waiver.
 1061         (2)(3) The agency shall adopt rules pursuant to ss.
 1062  120.536(1) and 120.54 necessary to implement this section.
 1063         Section 28. Section 400.111, Florida Statutes, is amended
 1064  to read:
 1065         400.111 Disclosure of controlling interest.—In addition to
 1066  the requirements of part II of chapter 408, when requested by
 1067  the agency, the licensee shall submit a signed affidavit
 1068  disclosing any financial or ownership interest that a
 1069  controlling interest has held within the last 5 years in any
 1070  entity licensed by the state or any other state to provide
 1071  health or residential care which entity has closed voluntarily
 1072  or involuntarily; has filed for bankruptcy; has had a receiver
 1073  appointed; has had a license denied, suspended, or revoked; or
 1074  has had an injunction issued against it which was initiated by a
 1075  regulatory agency. The affidavit must disclose the reason such
 1076  entity was closed, whether voluntarily or involuntarily.
 1077         Section 29. Subsection (2) of section 400.1183, Florida
 1078  Statutes, is amended to read:
 1079         400.1183 Resident grievance procedures.—
 1080         (2) Each facility shall maintain records of all grievances
 1081  and shall retain a log for agency inspection of report to the
 1082  agency at the time of relicensure the total number of grievances
 1083  handled during the prior licensure period, a categorization of
 1084  the cases underlying the grievances, and the final disposition
 1085  of the grievances.
 1086         Section 30. Paragraphs (o) through (w) of subsection (1) of
 1087  section 400.141, Florida Statutes, are redesignated as
 1088  paragraphs (n) through (u), respectively, present paragraphs
 1089  (f), (g), (j), (n), (o), and (r) of that subsection are amended,
 1090  and subsection (3) is added to that section, to read:
 1091         400.141 Administration and management of nursing home
 1092  facilities.—
 1093         (1) Every licensed facility shall comply with all
 1094  applicable standards and rules of the agency and shall:
 1095         (f) Be allowed and encouraged by the agency to provide
 1096  other needed services under certain conditions. If the facility
 1097  has a standard licensure status, and has had no class I or class
 1098  II deficiencies during the past 2 years or has been awarded a
 1099  Gold Seal under the program established in s. 400.235, it may be
 1100  encouraged by the agency to provide services, including, but not
 1101  limited to, respite and adult day services, which enable
 1102  individuals to move in and out of the facility. A facility is
 1103  not subject to any additional licensure requirements for
 1104  providing these services, under the following conditions:.
 1105         1. Respite care may be offered to persons in need of short
 1106  term or temporary nursing home services. For each person
 1107  admitted under the respite care program, the facility licensee
 1108  must:
 1109         a. Have a written abbreviated plan of care that, at a
 1110  minimum, includes nutritional requirements, medication orders,
 1111  physician orders, nursing assessments, and dietary preferences.
 1112  The nursing or physician assessments may take the place of all
 1113  other assessments required for full-time residents.
 1114         b. Have a contract that, at a minimum, specifies the
 1115  services to be provided to the respite resident, including
 1116  charges for services, activities, equipment, emergency medical
 1117  services, and the administration of medications. If multiple
 1118  respite admissions for a single person are anticipated, the
 1119  original contract is valid for 1 year after the date of
 1120  execution.
 1121         c. Ensure that each resident is released to his or her
 1122  caregiver or an individual designated in writing by the
 1123  caregiver.
 1124         2. A person admitted under the respite care program is:
 1125         a. Exempt from requirements in rule related to discharge
 1126  planning.
 1127         b. Covered by the residents’ rights set forth in s.
 1128  400.022(1)(a)-(o) and (r)-(t). Funds or property of the resident
 1129  shall not be considered trust funds subject to the requirements
 1130  of s. 400.022(1)(h) until the resident has been in the facility
 1131  for more than 14 consecutive days.
 1132         c. Allowed to use his or her personal medications for the
 1133  respite stay if permitted by facility policy. The facility must
 1134  obtain a physician’s order for the medications. The caregiver
 1135  may provide information regarding the medications as part of the
 1136  nursing assessment and that information must agree with the
 1137  physician’s order. Medications shall be released with the
 1138  resident upon discharge in accordance with current physician’s
 1139  orders.
 1140         3. A person receiving respite care is entitled to reside in
 1141  the facility for a total of 60 days within a contract year or
 1142  within a calendar year if the contract is for less than 12
 1143  months. However, each single stay may not exceed 14 days. If a
 1144  stay exceeds 14 consecutive days, the facility must comply with
 1145  all assessment and care planning requirements applicable to
 1146  nursing home residents.
 1147         4. A person receiving respite care must reside in a
 1148  licensed nursing home bed.
 1149         5. A prospective respite resident must provide medical
 1150  information from a physician, a physician assistant, or a nurse
 1151  practitioner and other information from the primary caregiver as
 1152  may be required by the facility prior to or at the time of
 1153  admission to receive respite care. The medical information must
 1154  include a physician’s order for respite care and proof of a
 1155  physical examination by a licensed physician, physician
 1156  assistant, or nurse practitioner. The physician’s order and
 1157  physical examination may be used to provide intermittent respite
 1158  care for up to 12 months after the date the order is written.
 1159         6. The facility must assume the duties of the primary
 1160  caregiver. To ensure continuity of care and services, the
 1161  resident is entitled to retain his or her personal physician and
 1162  must have access to medically necessary services such as
 1163  physical therapy, occupational therapy, or speech therapy, as
 1164  needed. The facility must arrange for transportation to these
 1165  services if necessary. Respite care must be provided in
 1166  accordance with this part and rules adopted by the agency.
 1167  However, the agency shall, by rule, adopt modified requirements
 1168  for resident assessment, resident care plans, resident
 1169  contracts, physician orders, and other provisions, as
 1170  appropriate, for short-term or temporary nursing home services.
 1171         7. The agency shall allow for shared programming and staff
 1172  in a facility which meets minimum standards and offers services
 1173  pursuant to this paragraph, but, if the facility is cited for
 1174  deficiencies in patient care, may require additional staff and
 1175  programs appropriate to the needs of service recipients. A
 1176  person who receives respite care may not be counted as a
 1177  resident of the facility for purposes of the facility’s licensed
 1178  capacity unless that person receives 24-hour respite care. A
 1179  person receiving either respite care for 24 hours or longer or
 1180  adult day services must be included when calculating minimum
 1181  staffing for the facility. Any costs and revenues generated by a
 1182  nursing home facility from nonresidential programs or services
 1183  shall be excluded from the calculations of Medicaid per diems
 1184  for nursing home institutional care reimbursement.
 1185         (g) If the facility has a standard license or is a Gold
 1186  Seal facility, exceeds the minimum required hours of licensed
 1187  nursing and certified nursing assistant direct care per resident
 1188  per day, and is part of a continuing care facility licensed
 1189  under chapter 651 or a retirement community that offers other
 1190  services pursuant to part III of this chapter or part I or part
 1191  III of chapter 429 on a single campus, be allowed to share
 1192  programming and staff. At the time of inspection and in the
 1193  semiannual report required pursuant to paragraph (o), a
 1194  continuing care facility or retirement community that uses this
 1195  option must demonstrate through staffing records that minimum
 1196  staffing requirements for the facility were met. Licensed nurses
 1197  and certified nursing assistants who work in the nursing home
 1198  facility may be used to provide services elsewhere on campus if
 1199  the facility exceeds the minimum number of direct care hours
 1200  required per resident per day and the total number of residents
 1201  receiving direct care services from a licensed nurse or a
 1202  certified nursing assistant does not cause the facility to
 1203  violate the staffing ratios required under s. 400.23(3)(a).
 1204  Compliance with the minimum staffing ratios shall be based on
 1205  total number of residents receiving direct care services,
 1206  regardless of where they reside on campus. If the facility
 1207  receives a conditional license, it may not share staff until the
 1208  conditional license status ends. This paragraph does not
 1209  restrict the agency’s authority under federal or state law to
 1210  require additional staff if a facility is cited for deficiencies
 1211  in care which are caused by an insufficient number of certified
 1212  nursing assistants or licensed nurses. The agency may adopt
 1213  rules for the documentation necessary to determine compliance
 1214  with this provision.
 1215         (j) Keep full records of resident admissions and
 1216  discharges; medical and general health status, including medical
 1217  records, personal and social history, and identity and address
 1218  of next of kin or other persons who may have responsibility for
 1219  the affairs of the residents; and individual resident care plans
 1220  including, but not limited to, prescribed services, service
 1221  frequency and duration, and service goals. The records shall be
 1222  open to inspection by the agency. The facility must maintain
 1223  clinical records on each resident in accordance with accepted
 1224  professional standards and practices that are complete,
 1225  accurately documented, readily accessible, and systematically
 1226  organized.
 1227         (n) Submit to the agency the information specified in s.
 1228  400.071(1)(b) for a management company within 30 days after the
 1229  effective date of the management agreement.
 1230         (n)(o)1. Submit semiannually to the agency, or more
 1231  frequently if requested by the agency, information regarding
 1232  facility staff-to-resident ratios, staff turnover, and staff
 1233  stability, including information regarding certified nursing
 1234  assistants, licensed nurses, the director of nursing, and the
 1235  facility administrator. For purposes of this reporting:
 1236         a. Staff-to-resident ratios must be reported in the
 1237  categories specified in s. 400.23(3)(a) and applicable rules.
 1238  The ratio must be reported as an average for the most recent
 1239  calendar quarter.
 1240         b. Staff turnover must be reported for the most recent 12
 1241  month period ending on the last workday of the most recent
 1242  calendar quarter prior to the date the information is submitted.
 1243  The turnover rate must be computed quarterly, with the annual
 1244  rate being the cumulative sum of the quarterly rates. The
 1245  turnover rate is the total number of terminations or separations
 1246  experienced during the quarter, excluding any employee
 1247  terminated during a probationary period of 3 months or less,
 1248  divided by the total number of staff employed at the end of the
 1249  period for which the rate is computed, and expressed as a
 1250  percentage.
 1251         c. The formula for determining staff stability is the total
 1252  number of employees that have been employed for more than 12
 1253  months, divided by the total number of employees employed at the
 1254  end of the most recent calendar quarter, and expressed as a
 1255  percentage.
 1256         d. A nursing facility that has failed to comply with state
 1257  minimum-staffing requirements for 2 consecutive days is
 1258  prohibited from accepting new admissions until the facility has
 1259  achieved the minimum-staffing requirements for a period of 6
 1260  consecutive days. For the purposes of this sub-subparagraph, any
 1261  person who was a resident of the facility and was absent from
 1262  the facility for the purpose of receiving medical care at a
 1263  separate location or was on a leave of absence is not considered
 1264  a new admission. Failure to impose such an admissions moratorium
 1265  is subject to a $1,000 fine constitutes a class II deficiency.
 1266         2.e. A nursing facility which does not have a conditional
 1267  license may be cited for failure to comply with the standards in
 1268  s. 400.23(3)(a)1.b. and c. only if it has failed to meet those
 1269  standards on 2 consecutive days or if it has failed to meet at
 1270  least 97 percent of those standards on any one day.
 1271         3.f. A facility which has a conditional license must be in
 1272  compliance with the standards in s. 400.23(3)(a) at all times.
 1273         (r)2. This subsection paragraph does not limit the agency’s
 1274  ability to impose a deficiency or take other actions if a
 1275  facility does not have enough staff to meet the residents’
 1276  needs.
 1277         (r) Report to the agency any filing for bankruptcy
 1278  protection by the facility or its parent corporation,
 1279  divestiture or spin-off of its assets, or corporate
 1280  reorganization within 30 days after the completion of such
 1281  activity.
 1282         (3)A facility may charge a reasonable fee for copying a
 1283  resident’s records. Such fee may not exceed $1 per page for the
 1284  first 25 pages and 25 cents per page for each page in excess of
 1285  25 pages.
 1286         Section 31. Subsection (3) of section 400.142, Florida
 1287  Statutes, is amended to read:
 1288         400.142 Emergency medication kits; orders not to
 1289  resuscitate.—
 1290         (3) Facility staff may withhold or withdraw cardiopulmonary
 1291  resuscitation if presented with an order not to resuscitate
 1292  executed pursuant to s. 401.45. The agency shall adopt rules
 1293  providing for the implementation of such orders. Facility staff
 1294  and facilities shall not be subject to criminal prosecution or
 1295  civil liability, nor be considered to have engaged in negligent
 1296  or unprofessional conduct, for withholding or withdrawing
 1297  cardiopulmonary resuscitation pursuant to such an order and
 1298  rules adopted by the agency. The absence of an order not to
 1299  resuscitate executed pursuant to s. 401.45 does not preclude a
 1300  physician from withholding or withdrawing cardiopulmonary
 1301  resuscitation as otherwise permitted by law.
 1302         Section 32. Section 400.145, Florida Statutes, is repealed.
 1303         Section 33. Present subsections (9), (11), (12), (13),
 1304  (14), and (15) of section 400.147, Florida Statutes, are
 1305  renumbered as subsections (8), (9), (10), (11), (12), and (13),
 1306  respectively, and present subsections (7), (8), and (10) of that
 1307  section are amended to read:
 1308         400.147 Internal risk management and quality assurance
 1309  program.—
 1310         (7) The facility shall initiate an investigation and shall
 1311  notify the agency within 1 business day after the risk manager
 1312  or his or her designee has received a report pursuant to
 1313  paragraph (1)(d). Each facility shall complete the investigation
 1314  and submit a report to the agency within 15 calendar days if the
 1315  incident is determined to be an adverse incident as defined in
 1316  subsection (5). The notification must be made in writing and be
 1317  provided electronically, by facsimile device or overnight mail
 1318  delivery. The agency shall develop a form for reporting this
 1319  information, and the notification must include the name of the
 1320  risk manager of the facility, information regarding the identity
 1321  of the affected resident, the type of adverse incident, the
 1322  initiation of an investigation by the facility, and whether the
 1323  events causing or resulting in the adverse incident represent a
 1324  potential risk to any other resident. The notification is
 1325  confidential as provided by law and is not discoverable or
 1326  admissible in any civil or administrative action, except in
 1327  disciplinary proceedings by the agency or the appropriate
 1328  regulatory board. The agency may investigate, as it deems
 1329  appropriate, any such incident and prescribe measures that must
 1330  or may be taken in response to the incident. The agency shall
 1331  review each report incident and determine whether it potentially
 1332  involved conduct by the health care professional who is subject
 1333  to disciplinary action, in which case the provisions of s.
 1334  456.073 shall apply.
 1335         (8)(a) Each facility shall complete the investigation and
 1336  submit an adverse incident report to the agency for each adverse
 1337  incident within 15 calendar days after its occurrence. If, after
 1338  a complete investigation, the risk manager determines that the
 1339  incident was not an adverse incident as defined in subsection
 1340  (5), the facility shall include this information in the report.
 1341  The agency shall develop a form for reporting this information.
 1342         (b) The information reported to the agency pursuant to
 1343  paragraph (a) which relates to persons licensed under chapter
 1344  458, chapter 459, chapter 461, or chapter 466 shall be reviewed
 1345  by the agency. The agency shall determine whether any of the
 1346  incidents potentially involved conduct by a health care
 1347  professional who is subject to disciplinary action, in which
 1348  case the provisions of s. 456.073 shall apply.
 1349         (c) The report submitted to the agency must also contain
 1350  the name of the risk manager of the facility.
 1351         (d) The adverse incident report is confidential as provided
 1352  by law and is not discoverable or admissible in any civil or
 1353  administrative action, except in disciplinary proceedings by the
 1354  agency or the appropriate regulatory board.
 1355         (10) By the 10th of each month, each facility subject to
 1356  this section shall report any notice received pursuant to s.
 1357  400.0233(2) and each initial complaint that was filed with the
 1358  clerk of the court and served on the facility during the
 1359  previous month by a resident or a resident’s family member,
 1360  guardian, conservator, or personal legal representative. The
 1361  report must include the name of the resident, the resident’s
 1362  date of birth and social security number, the Medicaid
 1363  identification number for Medicaid-eligible persons, the date or
 1364  dates of the incident leading to the claim or dates of
 1365  residency, if applicable, and the type of injury or violation of
 1366  rights alleged to have occurred. Each facility shall also submit
 1367  a copy of the notices received pursuant to s. 400.0233(2) and
 1368  complaints filed with the clerk of the court. This report is
 1369  confidential as provided by law and is not discoverable or
 1370  admissible in any civil or administrative action, except in such
 1371  actions brought by the agency to enforce the provisions of this
 1372  part.
 1373         Section 34. Section 400.148, Florida Statutes, is repealed.
 1374         Section 35. Paragraph (e) of subsection (2) of section
 1375  400.179, Florida Statutes, is amended to read:
 1376         400.179 Liability for Medicaid underpayments and
 1377  overpayments.—
 1378         (2) Because any transfer of a nursing facility may expose
 1379  the fact that Medicaid may have underpaid or overpaid the
 1380  transferor, and because in most instances, any such underpayment
 1381  or overpayment can only be determined following a formal field
 1382  audit, the liabilities for any such underpayments or
 1383  overpayments shall be as follows:
 1384         (e) For the 2009-2010 fiscal year only, the provisions of
 1385  paragraph (d) shall not apply. This paragraph expires July 1,
 1386  2010.
 1387         Section 36. Subsection (3) of section 400.19, Florida
 1388  Statutes, is amended to read:
 1389         400.19 Right of entry and inspection.—
 1390         (3) The agency shall every 15 months conduct at least one
 1391  unannounced inspection to determine compliance by the licensee
 1392  with statutes, and with rules promulgated under the provisions
 1393  of those statutes, governing minimum standards of construction,
 1394  quality and adequacy of care, and rights of residents. The
 1395  survey shall be conducted every 6 months for the next 2-year
 1396  period if the facility has been cited for a class I deficiency,
 1397  has been cited for two or more class II deficiencies arising
 1398  from separate surveys or investigations within a 60-day period,
 1399  or has had three or more substantiated complaints within a 6
 1400  month period, each resulting in at least one class I or class II
 1401  deficiency. In addition to any other fees or fines in this part,
 1402  the agency shall assess a fine for each facility that is subject
 1403  to the 6-month survey cycle. The fine for the 2-year period
 1404  shall be $6,000, one-half to be paid at the completion of each
 1405  survey. The agency may adjust this fine by the change in the
 1406  Consumer Price Index, based on the 12 months immediately
 1407  preceding the increase, to cover the cost of the additional
 1408  surveys. The agency shall verify through subsequent inspection
 1409  that any deficiency identified during inspection is corrected.
 1410  However, the agency may verify the correction of a class III or
 1411  class IV deficiency unrelated to resident rights or resident
 1412  care without reinspecting the facility if adequate written
 1413  documentation has been received from the facility, which
 1414  provides assurance that the deficiency has been corrected. The
 1415  giving or causing to be given of advance notice of such
 1416  unannounced inspections by an employee of the agency to any
 1417  unauthorized person shall constitute cause for suspension of not
 1418  fewer than 5 working days according to the provisions of chapter
 1419  110.
 1420         Section 37. Subsection (5) of section 400.23, Florida
 1421  Statutes, is amended to read:
 1422         400.23 Rules; evaluation and deficiencies; licensure
 1423  status.—
 1424         (5)(a) The agency, in collaboration with the Division of
 1425  Children’s Medical Services Network of the Department of Health,
 1426  must, no later than December 31, 1993, adopt rules for minimum
 1427  standards of care for persons under 21 years of age who reside
 1428  in nursing home facilities. The rules must include a methodology
 1429  for reviewing a nursing home facility under ss. 408.031-408.045
 1430  which serves only persons under 21 years of age. A facility may
 1431  be exempt from these standards for specific persons between 18
 1432  and 21 years of age, if the person’s physician agrees that
 1433  minimum standards of care based on age are not necessary.
 1434         (b) The agency, in collaboration with the Division of
 1435  Children’s Medical Services Network, shall adopt rules for
 1436  minimum staffing requirements for nursing home facilities that
 1437  serve persons under 21 years of age, which shall apply in lieu
 1438  of the standards contained in subsection (3).
 1439         1. For persons under 21 years of age who require skilled
 1440  care, the requirements shall include a minimum combined average
 1441  of licensed nurses, respiratory therapists, respiratory care
 1442  practitioners, and certified nursing assistants of 3.9 hours of
 1443  direct care per resident per day for each nursing home facility.
 1444         2. For persons under 21 years of age who are fragile, the
 1445  requirements shall include a minimum combined average of
 1446  licensed nurses, respiratory therapists, respiratory care
 1447  practitioners, and certified nursing assistants of 5 hours of
 1448  direct care per resident per day for each nursing home facility.
 1449         Section 38. Subsection (1) of section 400.275, Florida
 1450  Statutes, is amended to read:
 1451         400.275 Agency duties.—
 1452         (1) The agency shall ensure that each newly hired nursing
 1453  home surveyor, as a part of basic training, is assigned full
 1454  time to a licensed nursing home for at least 2 days within a 7
 1455  day period to observe facility operations outside of the survey
 1456  process before the surveyor begins survey responsibilities. Such
 1457  observations may not be the sole basis of a deficiency citation
 1458  against the facility. The agency may not assign an individual to
 1459  be a member of a survey team for purposes of a survey,
 1460  evaluation, or consultation visit at a nursing home facility in
 1461  which the surveyor was an employee within the preceding 2 5
 1462  years.
 1463         Section 39. Subsection (27) of section 400.462, Florida
 1464  Statutes, is amended to read:
 1465         400.462 Definitions.—As used in this part, the term:
 1466         (27) “Remuneration” means any payment or other benefit made
 1467  directly or indirectly, overtly or covertly, in cash or in kind.
 1468  However, when the term is used in any provision of law relating
 1469  to health care providers, such term does not mean an item that
 1470  has an individual value of up to $10, including, but not limited
 1471  to, a plaque, a certificate, a trophy, or a novelty item that is
 1472  intended solely for presentation or is customarily given away
 1473  solely for promotional, recognition, or advertising purposes.
 1474         Section 40. Subsection (2) of section 400.484, Florida
 1475  Statutes, is amended to read:
 1476         400.484 Right of inspection; violations deficiencies;
 1477  fines.—
 1478         (2) The agency shall impose fines for various classes of
 1479  violations deficiencies in accordance with the following
 1480  schedule:
 1481         (a) Class I violations are defined in s. 408.813. A class I
 1482  deficiency is any act, omission, or practice that results in a
 1483  patient’s death, disablement, or permanent injury, or places a
 1484  patient at imminent risk of death, disablement, or permanent
 1485  injury. Upon finding a class I violation deficiency, the agency
 1486  shall impose an administrative fine in the amount of $15,000 for
 1487  each occurrence and each day that the violation deficiency
 1488  exists.
 1489         (b) Class II violations are defined in s. 408.813. A class
 1490  II deficiency is any act, omission, or practice that has a
 1491  direct adverse effect on the health, safety, or security of a
 1492  patient. Upon finding a class II violation deficiency, the
 1493  agency shall impose an administrative fine in the amount of
 1494  $5,000 for each occurrence and each day that the violation
 1495  deficiency exists.
 1496         (c) Class III violations are defined in s. 408.813. A class
 1497  III deficiency is any act, omission, or practice that has an
 1498  indirect, adverse effect on the health, safety, or security of a
 1499  patient. Upon finding an uncorrected or repeated class III
 1500  violation deficiency, the agency shall impose an administrative
 1501  fine not to exceed $1,000 for each occurrence and each day that
 1502  the uncorrected or repeated violation deficiency exists.
 1503         (d) Class IV violations are defined in s. 408.813. A class
 1504  IV deficiency is any act, omission, or practice related to
 1505  required reports, forms, or documents which does not have the
 1506  potential of negatively affecting patients. These violations are
 1507  of a type that the agency determines do not threaten the health,
 1508  safety, or security of patients. Upon finding an uncorrected or
 1509  repeated class IV violation deficiency, the agency shall impose
 1510  an administrative fine not to exceed $500 for each occurrence
 1511  and each day that the uncorrected or repeated violation
 1512  deficiency exists.
 1513         Section 41. Paragraph (a) of section (15) of section
 1514  400.506, Florida Statutes, is amended, present subsection (17)
 1515  of that section is renumbered as subsection (18), and a new
 1516  subsection (17) is added to that section, to read:
 1517         400.506 Licensure of nurse registries; requirements;
 1518  penalties.—
 1519         (15)(a) The agency may deny, suspend, or revoke the license
 1520  of a nurse registry and shall impose a fine of $5,000 against a
 1521  nurse registry that:
 1522         1. Provides services to residents in an assisted living
 1523  facility for which the nurse registry does not receive fair
 1524  market value remuneration.
 1525         2. Provides staffing to an assisted living facility for
 1526  which the nurse registry does not receive fair market value
 1527  remuneration.
 1528         3. Fails to provide the agency, upon request, with copies
 1529  of all contracts with assisted living facilities which were
 1530  executed within the last 5 years.
 1531         4. Gives remuneration to a case manager, discharge planner,
 1532  facility-based staff member, or third-party vendor who is
 1533  involved in the discharge planning process of a facility
 1534  licensed under chapter 395 or this chapter and from whom the
 1535  nurse registry receives referrals. A nurse registry is exempt
 1536  from this subparagraph if it does not bill the Florida Medicaid
 1537  program or the Medicare program or share a controlling interest
 1538  with any entity licensed, registered, or certified under part II
 1539  of chapter 408 that bills the Florida Medicaid program or the
 1540  Medicare program.
 1541         5. Gives remuneration to a physician, a member of the
 1542  physician’s office staff, or an immediate family member of the
 1543  physician, and the nurse registry received a patient referral in
 1544  the last 12 months from that physician or the physician’s office
 1545  staff. A nurse registry is exempt from this subparagraph if it
 1546  does not bill the Florida Medicaid program or the Medicare
 1547  program or share a controlling interest with any entity
 1548  licensed, registered, or certified under part II of chapter 408
 1549  that bills the Florida Medicaid program or the Medicare program.
 1550         (17)An administrator may manage only one nurse registry.
 1551  However, an administrator may manage up to five nurse registries
 1552  if all five registries have identical controlling interests, as
 1553  defined in s. 408.803, and are located within one agency
 1554  geographic service area or within an immediately contiguous
 1555  county. An administrator shall designate, in writing, for each
 1556  licensed entity, a qualified alternate administrator to serve
 1557  during the administrator’s absence.
 1558         Section 42. Subsection (1) of section 400.509, Florida
 1559  Statutes, is amended to read:
 1560         400.509 Registration of particular service providers exempt
 1561  from licensure; certificate of registration; regulation of
 1562  registrants.—
 1563         (1) Any organization that provides companion services or
 1564  homemaker services and does not provide a home health service to
 1565  a person is exempt from licensure under this part. However, any
 1566  organization that provides companion services or homemaker
 1567  services must register with the agency. Organizations that
 1568  provide companion services only for persons with developmental
 1569  disabilities, as defined in s. 393.063, under contract with the
 1570  Agency for Persons with Disabilities, are exempt from
 1571  registration with the agency.
 1572         Section 43. For the purpose of incorporating the amendment
 1573  made by this act to section 400.509, Florida Statutes, in a
 1574  reference thereto, paragraph (b) of subsection (5) of section
 1575  400.464, Florida Statutes, is reenacted to read:
 1576         400.464 Home health agencies to be licensed; expiration of
 1577  license; exemptions; unlawful acts; penalties.—
 1578         (5) The following are exempt from the licensure
 1579  requirements of this part:
 1580         (b) Home health services provided by a state agency, either
 1581  directly or through a contractor with:
 1582         1. The Department of Elderly Affairs.
 1583         2. The Department of Health, a community health center, or
 1584  a rural health network that furnishes home visits for the
 1585  purpose of providing environmental assessments, case management,
 1586  health education, personal care services, family planning, or
 1587  followup treatment, or for the purpose of monitoring and
 1588  tracking disease.
 1589         3. Services provided to persons with developmental
 1590  disabilities, as defined in s. 393.063.
 1591         4. Companion and sitter organizations that were registered
 1592  under s. 400.509(1) on January 1, 1999, and were authorized to
 1593  provide personal services under a developmental services
 1594  provider certificate on January 1, 1999, may continue to provide
 1595  such services to past, present, and future clients of the
 1596  organization who need such services, notwithstanding the
 1597  provisions of this act.
 1598         5. The Department of Children and Family Services.
 1599         Section 44. For the purpose of incorporating the amendment
 1600  made by this act to section 400.509, Florida Statutes, in a
 1601  reference thereto, paragraph (a) of subsection (6) of section
 1602  400.506, Florida Statutes, is reenacted to read:
 1603         400.506 Licensure of nurse registries; requirements;
 1604  penalties.—
 1605         (6)(a) A nurse registry may refer for contract in private
 1606  residences registered nurses and licensed practical nurses
 1607  registered and licensed under part I of chapter 464, certified
 1608  nursing assistants certified under part II of chapter 464, home
 1609  health aides who present documented proof of successful
 1610  completion of the training required by rule of the agency, and
 1611  companions or homemakers for the purposes of providing those
 1612  services authorized under s. 400.509(1). A licensed nurse
 1613  registry shall ensure that each certified nursing assistant
 1614  referred for contract by the nurse registry and each home health
 1615  aide referred for contract by the nurse registry is adequately
 1616  trained to perform the tasks of a home health aide in the home
 1617  setting. Each person referred by a nurse registry must provide
 1618  current documentation that he or she is free from communicable
 1619  diseases.
 1620         Section 45. Paragraph (i) of subsection (1) and subsection
 1621  (4) of section 400.606, Florida Statutes, are amended to read:
 1622         400.606 License; application; renewal; conditional license
 1623  or permit; certificate of need.—
 1624         (1) In addition to the requirements of part II of chapter
 1625  408, the initial application and change of ownership application
 1626  must be accompanied by a plan for the delivery of home,
 1627  residential, and homelike inpatient hospice services to
 1628  terminally ill persons and their families. Such plan must
 1629  contain, but need not be limited to:
 1630         (i) The projected annual operating cost of the hospice.
 1631  
 1632  If the applicant is an existing licensed health care provider,
 1633  the application must be accompanied by a copy of the most recent
 1634  profit-loss statement and, if applicable, the most recent
 1635  licensure inspection report.
 1636         (4) A freestanding hospice facility that is primarily
 1637  engaged in providing inpatient and related services and that is
 1638  not otherwise licensed as a health care facility shall be
 1639  required to obtain a certificate of need. However, a
 1640  freestanding hospice facility with six or fewer beds shall not
 1641  be required to comply with institutional standards such as, but
 1642  not limited to, standards requiring sprinkler systems, emergency
 1643  electrical systems, or special lavatory devices.
 1644         Section 46. Subsection (2) of section 400.607, Florida
 1645  Statutes, is amended to read:
 1646         400.607 Denial, suspension, revocation of license;
 1647  emergency actions; imposition of administrative fine; grounds.—
 1648         (2) A violation of this part, part II of chapter 408, or
 1649  applicable rules Any of the following actions by a licensed
 1650  hospice or any of its employees shall be grounds for
 1651  administrative action by the agency against a hospice.:
 1652         (a) A violation of the provisions of this part, part II of
 1653  chapter 408, or applicable rules.
 1654         (b) An intentional or negligent act materially affecting
 1655  the health or safety of a patient.
 1656         Section 47. Section 400.915, Florida Statutes, is amended
 1657  to read:
 1658         400.915 Construction and renovation; requirements.—The
 1659  requirements for the construction or renovation of a PPEC center
 1660  shall comply with:
 1661         (1) The provisions of chapter 553, which pertain to
 1662  building construction standards, including plumbing, electrical
 1663  code, glass, manufactured buildings, accessibility for the
 1664  physically disabled;
 1665         (2) The provisions of s. 633.022 and applicable rules
 1666  pertaining to physical minimum standards for nonresidential
 1667  child care physical facilities in rule 10M-12.003, Florida
 1668  Administrative Code, Child Care Standards; and
 1669         (3) The standards or rules adopted pursuant to this part
 1670  and part II of chapter 408.
 1671         Section 48. Subsection (1) of section 400.925, Florida
 1672  Statutes, is amended to read:
 1673         400.925 Definitions.—As used in this part, the term:
 1674         (1) “Accrediting organizations” means the Joint Commission
 1675  on Accreditation of Healthcare Organizations or other national
 1676  accreditation agencies whose standards for accreditation are
 1677  comparable to those required by this part for licensure.
 1678         Section 49. Section 400.931, Florida Statutes, is amended
 1679  to read:
 1680         400.931 Application for license; documentation of
 1681  accreditation; fee; provisional license; temporary permit.—
 1682         (1) In addition to the requirements of part II of chapter
 1683  408, the applicant must file with the application satisfactory
 1684  proof that the home medical equipment provider is in compliance
 1685  with this part and applicable rules, including:
 1686         (a) A report, by category, of the equipment to be provided,
 1687  indicating those offered either directly by the applicant or
 1688  through contractual arrangements with existing providers.
 1689  Categories of equipment include:
 1690         1. Respiratory modalities.
 1691         2. Ambulation aids.
 1692         3. Mobility aids.
 1693         4. Sickroom setup.
 1694         5. Disposables.
 1695         (b) A report, by category, of the services to be provided,
 1696  indicating those offered either directly by the applicant or
 1697  through contractual arrangements with existing providers.
 1698  Categories of services include:
 1699         1. Intake.
 1700         2. Equipment selection.
 1701         3. Delivery.
 1702         4. Setup and installation.
 1703         5. Patient training.
 1704         6. Ongoing service and maintenance.
 1705         7. Retrieval.
 1706         (c) A listing of those with whom the applicant contracts,
 1707  both the providers the applicant uses to provide equipment or
 1708  services to its consumers and the providers for whom the
 1709  applicant provides services or equipment.
 1710         (2) An applicant for initial licensure, change of
 1711  ownership, or renewal to operate a licensed home medical
 1712  equipment provider at a location outside the state of Florida
 1713  must submit documentation of accreditation, or an application
 1714  for accreditation, from an accrediting organization that is
 1715  recognized by the agency. An applicant that has applied for
 1716  accreditation must provide proof of accreditation that is not
 1717  conditional or provisional within 120 days after the date of the
 1718  agency’s receipt of the application for licensure or the
 1719  application shall be withdrawn from further consideration. Such
 1720  accreditation must be maintained by the home medical equipment
 1721  provider in order to maintain licensure. As an alternative to
 1722  submitting proof of financial ability to operate as required in
 1723  s. 408.810(8), the applicant may submit a $50,000 surety bond to
 1724  the agency.
 1725         (3) As specified in part II of chapter 408, the home
 1726  medical equipment provider must also obtain and maintain
 1727  professional and commercial liability insurance. Proof of
 1728  liability insurance, as defined in s. 624.605, must be submitted
 1729  with the application. The agency shall set the required amounts
 1730  of liability insurance by rule, but the required amount must not
 1731  be less than $250,000 per claim. In the case of contracted
 1732  services, it is required that the contractor have liability
 1733  insurance not less than $250,000 per claim.
 1734         (4) When a change of the general manager of a home medical
 1735  equipment provider occurs, the licensee must notify the agency
 1736  of the change within 45 days.
 1737         (5) In accordance with s. 408.805, an applicant or a
 1738  licensee shall pay a fee for each license application submitted
 1739  under this part, part II of chapter 408, and applicable rules.
 1740  The amount of the fee shall be established by rule and may not
 1741  exceed $300 per biennium. The agency shall set the fees in an
 1742  amount that is sufficient to cover its costs in carrying out its
 1743  responsibilities under this part. However, state, county, or
 1744  municipal governments applying for licenses under this part are
 1745  exempt from the payment of license fees.
 1746         (6) An applicant for initial licensure, renewal, or change
 1747  of ownership shall also pay an inspection fee not to exceed
 1748  $400, which shall be paid by all applicants except those not
 1749  subject to licensure inspection by the agency as described in s.
 1750  400.933.
 1751         Section 50. Subsection (2) of section 400.932, Florida
 1752  Statutes, is amended to read:
 1753         400.932 Administrative penalties.—
 1754         (2) A violation of this part, part II of chapter 408, or
 1755  applicable rules Any of the following actions by an employee of
 1756  a home medical equipment provider shall be are grounds for
 1757  administrative action or penalties by the agency.:
 1758         (a) Violation of this part, part II of chapter 408, or
 1759  applicable rules.
 1760         (b) An intentional, reckless, or negligent act that
 1761  materially affects the health or safety of a patient.
 1762         Section 51. Subsection (3) of section 400.967, Florida
 1763  Statutes, is amended to read:
 1764         400.967 Rules and classification of violations
 1765  deficiencies.—
 1766         (3) The agency shall adopt rules to provide that, when the
 1767  criteria established under this part and part II of chapter 408
 1768  are not met, such violations deficiencies shall be classified
 1769  according to the nature of the violation deficiency. The agency
 1770  shall indicate the classification on the face of the notice of
 1771  deficiencies as follows:
 1772         (a) Class I violations deficiencies are defined in s.
 1773  408.813 those which the agency determines present an imminent
 1774  danger to the residents or guests of the facility or a
 1775  substantial probability that death or serious physical harm
 1776  would result therefrom. The condition or practice constituting a
 1777  class I violation must be abated or eliminated immediately,
 1778  unless a fixed period of time, as determined by the agency, is
 1779  required for correction. A class I violation deficiency is
 1780  subject to a civil penalty in an amount not less than $5,000 and
 1781  not exceeding $10,000 for each violation deficiency. A fine may
 1782  be levied notwithstanding the correction of the violation
 1783  deficiency.
 1784         (b) Class II violations deficiencies are defined in s.
 1785  408.813 those which the agency determines have a direct or
 1786  immediate relationship to the health, safety, or security of the
 1787  facility residents, other than class I deficiencies. A class II
 1788  violation deficiency is subject to a civil penalty in an amount
 1789  not less than $1,000 and not exceeding $5,000 for each violation
 1790  deficiency. A citation for a class II violation deficiency shall
 1791  specify the time within which the violation deficiency must be
 1792  corrected. If a class II violation deficiency is corrected
 1793  within the time specified, no civil penalty shall be imposed,
 1794  unless it is a repeated offense.
 1795         (c) Class III violations deficiencies are defined in s.
 1796  408.813 those which the agency determines to have an indirect or
 1797  potential relationship to the health, safety, or security of the
 1798  facility residents, other than class I or class II deficiencies.
 1799  A class III violation deficiency is subject to a civil penalty
 1800  of not less than $500 and not exceeding $1,000 for each
 1801  deficiency. A citation for a class III violation deficiency
 1802  shall specify the time within which the violation deficiency
 1803  must be corrected. If a class III violation deficiency is
 1804  corrected within the time specified, no civil penalty shall be
 1805  imposed, unless it is a repeated offense.
 1806         (d) Class IV violations are defined in s. 408.813. Upon
 1807  finding an uncorrected or repeated class IV violation, the
 1808  agency shall impose an administrative fine not to exceed $500
 1809  for each occurrence and each day that the uncorrected or
 1810  repeated violation exists.
 1811         Section 52. Subsections (4) and (7) of section 400.9905,
 1812  Florida Statutes, are amended to read:
 1813         400.9905 Definitions.—
 1814         (4) “Clinic” means an entity at which health care services
 1815  are provided to individuals and which tenders charges for
 1816  reimbursement for such services, including a mobile clinic and a
 1817  portable health service or equipment provider. For purposes of
 1818  this part, the term does not include and the licensure
 1819  requirements of this part do not apply to:
 1820         (a) Entities licensed or registered by the state under
 1821  chapter 395; or entities licensed or registered by the state and
 1822  providing only health care services within the scope of services
 1823  authorized under their respective licenses granted under ss.
 1824  383.30-383.335, chapter 390, chapter 394, chapter 397, this
 1825  chapter except part X, chapter 429, chapter 463, chapter 465,
 1826  chapter 466, chapter 478, part I of chapter 483, chapter 484, or
 1827  chapter 651; end-stage renal disease providers authorized under
 1828  42 C.F.R. part 405, subpart U; or providers certified under 42
 1829  C.F.R. part 485, subpart B or subpart H; or any entity that
 1830  provides neonatal or pediatric hospital-based health care
 1831  services or other health care services by licensed practitioners
 1832  solely within a hospital licensed under chapter 395.
 1833         (b) Entities that own, directly or indirectly, entities
 1834  licensed or registered by the state pursuant to chapter 395; or
 1835  entities that own, directly or indirectly, entities licensed or
 1836  registered by the state and providing only health care services
 1837  within the scope of services authorized pursuant to their
 1838  respective licenses granted under ss. 383.30-383.335, chapter
 1839  390, chapter 394, chapter 397, this chapter except part X,
 1840  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1841  part I of chapter 483, chapter 484, chapter 651; end-stage renal
 1842  disease providers authorized under 42 C.F.R. part 405, subpart
 1843  U; or providers certified under 42 C.F.R. part 485, subpart B or
 1844  subpart H; or any entity that provides neonatal or pediatric
 1845  hospital-based health care services by licensed practitioners
 1846  solely within a hospital licensed under chapter 395.
 1847         (c) Entities that are owned, directly or indirectly, by an
 1848  entity licensed or registered by the state pursuant to chapter
 1849  395; or entities that are owned, directly or indirectly, by an
 1850  entity licensed or registered by the state and providing only
 1851  health care services within the scope of services authorized
 1852  pursuant to their respective licenses granted under ss. 383.30
 1853  383.335, chapter 390, chapter 394, chapter 397, this chapter
 1854  except part X, chapter 429, chapter 463, chapter 465, chapter
 1855  466, chapter 478, part I of chapter 483, chapter 484, or chapter
 1856  651; end-stage renal disease providers authorized under 42
 1857  C.F.R. part 405, subpart U; or providers certified under 42
 1858  C.F.R. part 485, subpart B or subpart H; or any entity that
 1859  provides neonatal or pediatric hospital-based health care
 1860  services by licensed practitioners solely within a hospital
 1861  under chapter 395.
 1862         (d) Entities that are under common ownership, directly or
 1863  indirectly, with an entity licensed or registered by the state
 1864  pursuant to chapter 395; or entities that are under common
 1865  ownership, directly or indirectly, with an entity licensed or
 1866  registered by the state and providing only health care services
 1867  within the scope of services authorized pursuant to their
 1868  respective licenses granted under ss. 383.30-383.335, chapter
 1869  390, chapter 394, chapter 397, this chapter except part X,
 1870  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1871  part I of chapter 483, chapter 484, or chapter 651; end-stage
 1872  renal disease providers authorized under 42 C.F.R. part 405,
 1873  subpart U; or providers certified under 42 C.F.R. part 485,
 1874  subpart B or subpart H; or any entity that provides neonatal or
 1875  pediatric hospital-based health care services by licensed
 1876  practitioners solely within a hospital licensed under chapter
 1877  395.
 1878         (e) An entity that is exempt from federal taxation under 26
 1879  U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
 1880  under 26 U.S.C. s. 409 that has a board of trustees not less
 1881  than two-thirds of which are Florida-licensed health care
 1882  practitioners and provides only physical therapy services under
 1883  physician orders, any community college or university clinic,
 1884  and any entity owned or operated by the federal or state
 1885  government, including agencies, subdivisions, or municipalities
 1886  thereof.
 1887         (f) A sole proprietorship, group practice, partnership, or
 1888  corporation that provides health care services by physicians
 1889  covered by s. 627.419, that is directly supervised by one or
 1890  more of such physicians, and that is wholly owned by one or more
 1891  of those physicians or by a physician and the spouse, parent,
 1892  child, or sibling of that physician.
 1893         (g) A sole proprietorship, group practice, partnership, or
 1894  corporation that provides health care services by licensed
 1895  health care practitioners under chapter 457, chapter 458,
 1896  chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
 1897  chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
 1898  chapter 490, chapter 491, or part I, part III, part X, part
 1899  XIII, or part XIV of chapter 468, or s. 464.012, which are
 1900  wholly owned by one or more licensed health care practitioners,
 1901  or the licensed health care practitioners set forth in this
 1902  paragraph and the spouse, parent, child, or sibling of a
 1903  licensed health care practitioner, so long as one of the owners
 1904  who is a licensed health care practitioner is supervising the
 1905  business activities and is legally responsible for the entity’s
 1906  compliance with all federal and state laws. However, a health
 1907  care practitioner may not supervise services beyond the scope of
 1908  the practitioner’s license, except that, for the purposes of
 1909  this part, a clinic owned by a licensee in s. 456.053(3)(b) that
 1910  provides only services authorized pursuant to s. 456.053(3)(b)
 1911  may be supervised by a licensee specified in s. 456.053(3)(b).
 1912         (h) Clinical facilities affiliated with an accredited
 1913  medical school at which training is provided for medical
 1914  students, residents, or fellows.
 1915         (i) Entities that provide only oncology or radiation
 1916  therapy services by physicians licensed under chapter 458 or
 1917  chapter 459 or entities that provide oncology or radiation
 1918  therapy services by physicians licensed under chapter 458 or
 1919  chapter 459 which are owned by a corporation whose shares are
 1920  publicly traded on a recognized stock exchange.
 1921         (j) Clinical facilities affiliated with a college of
 1922  chiropractic accredited by the Council on Chiropractic Education
 1923  at which training is provided for chiropractic students.
 1924         (k) Entities that provide licensed practitioners to staff
 1925  emergency departments or to deliver anesthesia services in
 1926  facilities licensed under chapter 395 and that derive at least
 1927  90 percent of their gross annual revenues from the provision of
 1928  such services. Entities claiming an exemption from licensure
 1929  under this paragraph must provide documentation demonstrating
 1930  compliance.
 1931         (l) Orthotic, or prosthetic, pediatric cardiology, or
 1932  perinatology clinical facilities that are a publicly traded
 1933  corporation or that are wholly owned, directly or indirectly, by
 1934  a publicly traded corporation. As used in this paragraph, a
 1935  publicly traded corporation is a corporation that issues
 1936  securities traded on an exchange registered with the United
 1937  States Securities and Exchange Commission as a national
 1938  securities exchange.
 1939         (m) Entities that are owned by a corporation that has $250
 1940  million or more in total annual sales of health care services
 1941  provided by licensed health care practitioners if one or more of
 1942  the owners of the entity is a health care practitioner who is
 1943  licensed in this state, is responsible for supervising the
 1944  business activities of the entity, and is legally responsible
 1945  for the entity’s compliance with state law for purposes of this
 1946  section.
 1947         (n) Entities that are owned or controlled, directly or
 1948  indirectly, by a publicly traded entity with $100 million or
 1949  more, in the aggregate, in total annual revenues derived from
 1950  providing health care services by licensed health care
 1951  practitioners that are employed or contracted by an entity
 1952  described in this paragraph.
 1953         (o) Entities that employ 50 or more health care
 1954  practitioners who are licensed under chapter 458 or chapter 459
 1955  if the billing for medical services is under a single corporate
 1956  tax identification number. The application for exemption under
 1957  this paragraph must contain information that includes the name,
 1958  residence address, business address, and telephone number of the
 1959  entity that owns the practice; a complete list of the names and
 1960  contact information of all the officers and directors of the
 1961  entity; the name, residence address, business address, and
 1962  medical license number of each health care practitioner who is
 1963  licensed to practice in this state and employed by the entity;
 1964  the corporate tax identification number of the entity seeking an
 1965  exemption; a listing of health care services to be provided by
 1966  the entity at the health care clinics owned or operated by the
 1967  entity; and a certified statement prepared by an independent
 1968  certified public accountant which states that the entity and the
 1969  health care clinics owned or operated by the entity have not
 1970  received payment for health care services under insurance
 1971  coverage for personal injury protection for the preceding year.
 1972  If the agency determines that an entity that is exempt under
 1973  this paragraph has received payments for medical services for
 1974  insurance coverage for personal injury protection, the agency
 1975  may deny or revoke the exemption from licensure under this
 1976  paragraph.
 1977         (7) “Portable health service or equipment provider” means
 1978  an entity that contracts with or employs persons to provide
 1979  portable health services or equipment to multiple locations
 1980  performing treatment or diagnostic testing of individuals, that
 1981  bills third-party payors for those services, and that otherwise
 1982  meets the definition of a clinic in subsection (4).
 1983         Section 53. Paragraph (b) of subsection (1) and paragraph
 1984  (c) of subsection (4) of section 400.991, Florida Statutes, are
 1985  amended to read:
 1986         400.991 License requirements; background screenings;
 1987  prohibitions.—
 1988         (1)
 1989         (b) Each mobile clinic must obtain a separate health care
 1990  clinic license and must provide to the agency, at least
 1991  quarterly, its projected street location to enable the agency to
 1992  locate and inspect such clinic. A portable health service or
 1993  equipment provider must obtain a health care clinic license for
 1994  a single administrative office and is not required to submit
 1995  quarterly projected street locations.
 1996         (4) In addition to the requirements of part II of chapter
 1997  408, the applicant must file with the application satisfactory
 1998  proof that the clinic is in compliance with this part and
 1999  applicable rules, including:
 2000         (c) Proof of financial ability to operate as required under
 2001  ss. s. 408.810(8) and 408.8065. As an alternative to submitting
 2002  proof of financial ability to operate as required under s.
 2003  408.810(8), the applicant may file a surety bond of at least
 2004  $500,000 which guarantees that the clinic will act in full
 2005  conformity with all legal requirements for operating a clinic,
 2006  payable to the agency. The agency may adopt rules to specify
 2007  related requirements for such surety bond.
 2008         Section 54. Paragraph (g) of subsection (1) and paragraph
 2009  (a) of subsection (7) of section 400.9935, Florida Statutes, are
 2010  amended to read:
 2011         400.9935 Clinic responsibilities.—
 2012         (1) Each clinic shall appoint a medical director or clinic
 2013  director who shall agree in writing to accept legal
 2014  responsibility for the following activities on behalf of the
 2015  clinic. The medical director or the clinic director shall:
 2016         (g) Conduct systematic reviews of clinic billings to ensure
 2017  that the billings are not fraudulent or unlawful. Upon discovery
 2018  of an unlawful charge, the medical director or clinic director
 2019  shall take immediate corrective action. If the clinic performs
 2020  only the technical component of magnetic resonance imaging,
 2021  static radiographs, computed tomography, or positron emission
 2022  tomography, and provides the professional interpretation of such
 2023  services, in a fixed facility that is accredited by the Joint
 2024  Commission on Accreditation of Healthcare Organizations or the
 2025  Accreditation Association for Ambulatory Health Care, and the
 2026  American College of Radiology; and if, in the preceding quarter,
 2027  the percentage of scans performed by that clinic which was
 2028  billed to all personal injury protection insurance carriers was
 2029  less than 15 percent, the chief financial officer of the clinic
 2030  may, in a written acknowledgment provided to the agency, assume
 2031  the responsibility for the conduct of the systematic reviews of
 2032  clinic billings to ensure that the billings are not fraudulent
 2033  or unlawful.
 2034         (7)(a) Each clinic engaged in magnetic resonance imaging
 2035  services must be accredited by the Joint Commission on
 2036  Accreditation of Healthcare Organizations, the American College
 2037  of Radiology, or the Accreditation Association for Ambulatory
 2038  Health Care, within 1 year after licensure. A clinic that is
 2039  accredited by the American College of Radiology or is within the
 2040  original 1-year period after licensure and replaces its core
 2041  magnetic resonance imaging equipment shall be given 1 year after
 2042  the date on which the equipment is replaced to attain
 2043  accreditation. However, a clinic may request a single, 6-month
 2044  extension if it provides evidence to the agency establishing
 2045  that, for good cause shown, such clinic cannot be accredited
 2046  within 1 year after licensure, and that such accreditation will
 2047  be completed within the 6-month extension. After obtaining
 2048  accreditation as required by this subsection, each such clinic
 2049  must maintain accreditation as a condition of renewal of its
 2050  license. A clinic that files a change of ownership application
 2051  must comply with the original accreditation timeframe
 2052  requirements of the transferor. The agency shall deny a change
 2053  of ownership application if the clinic is not in compliance with
 2054  the accreditation requirements. When a clinic adds, replaces, or
 2055  modifies magnetic resonance imaging equipment and the
 2056  accreditation agency requires new accreditation, the clinic must
 2057  be accredited within 1 year after the date of the addition,
 2058  replacement, or modification but may request a single, 6-month
 2059  extension if the clinic provides evidence of good cause to the
 2060  agency.
 2061         Section 55. Paragraph (a) of subsection (2) of section
 2062  408.033, Florida Statutes, is amended to read:
 2063         408.033 Local and state health planning.—
 2064         (2) FUNDING.—
 2065         (a) The Legislature intends that the cost of local health
 2066  councils be borne by assessments on selected health care
 2067  facilities subject to facility licensure by the Agency for
 2068  Health Care Administration, including abortion clinics, assisted
 2069  living facilities, ambulatory surgical centers, birthing
 2070  centers, clinical laboratories except community nonprofit blood
 2071  banks and clinical laboratories operated by practitioners for
 2072  exclusive use regulated under s. 483.035, home health agencies,
 2073  hospices, hospitals, intermediate care facilities for the
 2074  developmentally disabled, nursing homes, health care clinics,
 2075  and multiphasic testing centers and by assessments on
 2076  organizations subject to certification by the agency pursuant to
 2077  chapter 641, part III, including health maintenance
 2078  organizations and prepaid health clinics. Any fee that is
 2079  assessed may be collected prospectively at the time a facility’s
 2080  license is renewed and prorated for the licensing period.
 2081         Section 56. Subsection (2) of section 408.034, Florida
 2082  Statutes, is amended to read:
 2083         408.034 Duties and responsibilities of agency; rules.—
 2084         (2) In the exercise of its authority to issue licenses to
 2085  health care facilities and health service providers, as provided
 2086  under chapters 393 and 395 and parts II, and IV, and VIII of
 2087  chapter 400, the agency may not issue a license to any health
 2088  care facility or health service provider that fails to receive a
 2089  certificate of need or an exemption for the licensed facility or
 2090  service.
 2091         Section 57. Paragraph (d) of subsection (1) and paragraph
 2092  (m) of subsection (3) of section 408.036, Florida Statutes, are
 2093  amended to read:
 2094         408.036 Projects subject to review; exemptions.—
 2095         (1) APPLICABILITY.—Unless exempt under subsection (3), all
 2096  health-care-related projects, as described in paragraphs (a)
 2097  (g), are subject to review and must file an application for a
 2098  certificate of need with the agency. The agency is exclusively
 2099  responsible for determining whether a health-care-related
 2100  project is subject to review under ss. 408.031-408.045.
 2101         (d) The establishment of a hospice or hospice inpatient
 2102  facility, except as provided in s. 408.043.
 2103         (3) EXEMPTIONS.—Upon request, the following projects are
 2104  subject to exemption from the provisions of subsection (1):
 2105         (m)1. For the provision of adult open-heart services in a
 2106  hospital located within the boundaries of a health service
 2107  planning district, as defined in s. 408.032(5), which has
 2108  experienced an annual net out-migration of at least 600 open
 2109  heart-surgery cases for 3 consecutive years according to the
 2110  most recent data reported to the agency, and the district’s
 2111  population per licensed and operational open-heart programs
 2112  exceeds the state average of population per licensed and
 2113  operational open-heart programs by at least 25 percent. All
 2114  hospitals within a health service planning district which meet
 2115  the criteria reference in sub-subparagraphs 2.a.-h. shall be
 2116  eligible for this exemption on July 1, 2004, and shall receive
 2117  the exemption upon filing for it and subject to the following:
 2118         a. A hospital that has received a notice of intent to grant
 2119  a certificate of need or a final order of the agency granting a
 2120  certificate of need for the establishment of an open-heart
 2121  surgery program is entitled to receive a letter of exemption for
 2122  the establishment of an adult open-heart-surgery program upon
 2123  filing a request for exemption and complying with the criteria
 2124  enumerated in sub-subparagraphs 2.a.-h., and is entitled to
 2125  immediately commence operation of the program.
 2126         b. An otherwise eligible hospital that has not received a
 2127  notice of intent to grant a certificate of need or a final order
 2128  of the agency granting a certificate of need for the
 2129  establishment of an open-heart-surgery program is entitled to
 2130  immediately receive a letter of exemption for the establishment
 2131  of an adult open-heart-surgery program upon filing a request for
 2132  exemption and complying with the criteria enumerated in sub
 2133  subparagraphs 2.a.-h., but is not entitled to commence operation
 2134  of its program until December 31, 2006.
 2135         2. A hospital shall be exempt from the certificate-of-need
 2136  review for the establishment of an open-heart-surgery program
 2137  when the application for exemption submitted under this
 2138  paragraph complies with the following criteria:
 2139         a. The applicant must certify that it will meet and
 2140  continuously maintain the minimum licensure requirements adopted
 2141  by the agency governing adult open-heart programs, including the
 2142  most current guidelines of the American College of Cardiology
 2143  and American Heart Association Guidelines for Adult Open Heart
 2144  Programs.
 2145         b. The applicant must certify that it will maintain
 2146  sufficient appropriate equipment and health personnel to ensure
 2147  quality and safety.
 2148         c. The applicant must certify that it will maintain
 2149  appropriate times of operation and protocols to ensure
 2150  availability and appropriate referrals in the event of
 2151  emergencies.
 2152         d. The applicant can demonstrate that it has discharged at
 2153  least 300 inpatients with a principal diagnosis of ischemic
 2154  heart disease for the most recent 12-month period as reported to
 2155  the agency.
 2156         e. The applicant is a general acute care hospital that is
 2157  in operation for 3 years or more.
 2158         f. The applicant is performing more than 300 diagnostic
 2159  cardiac catheterization procedures per year, combined inpatient
 2160  and outpatient.
 2161         g. The applicant’s payor mix at a minimum reflects the
 2162  community average for Medicaid, charity care, and self-pay
 2163  patients or the applicant must certify that it will provide a
 2164  minimum of 5 percent of Medicaid, charity care, and self-pay to
 2165  open-heart-surgery patients.
 2166         h. If the applicant fails to meet the established criteria
 2167  for open-heart programs or fails to reach 300 surgeries per year
 2168  by the end of its third year of operation, it must show cause
 2169  why its exemption should not be revoked.
 2170         3. By December 31, 2004, and annually thereafter, the
 2171  agency shall submit a report to the Legislature providing
 2172  information concerning the number of requests for exemption it
 2173  has received under this paragraph during the calendar year and
 2174  the number of exemptions it has granted or denied during the
 2175  calendar year.
 2176         Section 58. Paragraph (c) of subsection (1) of section
 2177  408.037, Florida Statutes, is amended to read:
 2178         408.037 Application content.—
 2179         (1) Except as provided in subsection (2) for a general
 2180  hospital, an application for a certificate of need must contain:
 2181         (c) An audited financial statement of the applicant or of
 2182  the applicant’s parent corporation if audited financial
 2183  statements of the applicant do not exist. In an application
 2184  submitted by an existing health care facility, health
 2185  maintenance organization, or hospice, financial condition
 2186  documentation must include, but need not be limited to, a
 2187  balance sheet and a profit-and-loss statement of the 2 previous
 2188  fiscal years’ operation.
 2189         Section 59. Subsection (2) of section 408.043, Florida
 2190  Statutes, is amended to read:
 2191         408.043 Special provisions.—
 2192         (2) HOSPICES.—When an application is made for a certificate
 2193  of need to establish or to expand a hospice, the need for such
 2194  hospice shall be determined on the basis of the need for and
 2195  availability of hospice services in the community. The formula
 2196  on which the certificate of need is based shall discourage
 2197  regional monopolies and promote competition. The inpatient
 2198  hospice care component of a hospice which is a freestanding
 2199  facility, or a part of a facility, which is primarily engaged in
 2200  providing inpatient care and related services and is not
 2201  licensed as a health care facility shall also be required to
 2202  obtain a certificate of need. Provision of hospice care by any
 2203  current provider of health care is a significant change in
 2204  service and therefore requires a certificate of need for such
 2205  services.
 2206         Section 60. Paragraph (k) of subsection (3) of section
 2207  408.05, Florida Statutes, is amended to read:
 2208         408.05 Florida Center for Health Information and Policy
 2209  Analysis.—
 2210         (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to
 2211  produce comparable and uniform health information and statistics
 2212  for the development of policy recommendations, the agency shall
 2213  perform the following functions:
 2214         (k) Develop, in conjunction with the State Consumer Health
 2215  Information and Policy Advisory Council, and implement a long
 2216  range plan for making available health care quality measures and
 2217  financial data that will allow consumers to compare health care
 2218  services. The health care quality measures and financial data
 2219  the agency must make available shall include, but is not limited
 2220  to, pharmaceuticals, physicians, health care facilities, and
 2221  health plans and managed care entities. The agency shall update
 2222  the plan and report on the status of its implementation
 2223  annually. The agency shall also make the plan and status report
 2224  available to the public on its Internet website. As part of the
 2225  plan, the agency shall identify the process and timeframes for
 2226  implementation, any barriers to implementation, and
 2227  recommendations of changes in the law that may be enacted by the
 2228  Legislature to eliminate the barriers. As preliminary elements
 2229  of the plan, the agency shall:
 2230         1. Make available patient-safety indicators, inpatient
 2231  quality indicators, and performance outcome and patient charge
 2232  data collected from health care facilities pursuant to s.
 2233  408.061(1)(a) and (2). The terms “patient-safety indicators” and
 2234  “inpatient quality indicators” shall be as defined by the
 2235  Centers for Medicare and Medicaid Services, the National Quality
 2236  Forum, the Joint Commission on Accreditation of Healthcare
 2237  Organizations, the Agency for Healthcare Research and Quality,
 2238  the Centers for Disease Control and Prevention, or a similar
 2239  national entity that establishes standards to measure the
 2240  performance of health care providers, or by other states. The
 2241  agency shall determine which conditions, procedures, health care
 2242  quality measures, and patient charge data to disclose based upon
 2243  input from the council. When determining which conditions and
 2244  procedures are to be disclosed, the council and the agency shall
 2245  consider variation in costs, variation in outcomes, and
 2246  magnitude of variations and other relevant information. When
 2247  determining which health care quality measures to disclose, the
 2248  agency:
 2249         a. Shall consider such factors as volume of cases; average
 2250  patient charges; average length of stay; complication rates;
 2251  mortality rates; and infection rates, among others, which shall
 2252  be adjusted for case mix and severity, if applicable.
 2253         b. May consider such additional measures that are adopted
 2254  by the Centers for Medicare and Medicaid Studies, National
 2255  Quality Forum, the Joint Commission on Accreditation of
 2256  Healthcare Organizations, the Agency for Healthcare Research and
 2257  Quality, Centers for Disease Control and Prevention, or a
 2258  similar national entity that establishes standards to measure
 2259  the performance of health care providers, or by other states.
 2260  
 2261  When determining which patient charge data to disclose, the
 2262  agency shall include such measures as the average of
 2263  undiscounted charges on frequently performed procedures and
 2264  preventive diagnostic procedures, the range of procedure charges
 2265  from highest to lowest, average net revenue per adjusted patient
 2266  day, average cost per adjusted patient day, and average cost per
 2267  admission, among others.
 2268         2. Make available performance measures, benefit design, and
 2269  premium cost data from health plans licensed pursuant to chapter
 2270  627 or chapter 641. The agency shall determine which health care
 2271  quality measures and member and subscriber cost data to
 2272  disclose, based upon input from the council. When determining
 2273  which data to disclose, the agency shall consider information
 2274  that may be required by either individual or group purchasers to
 2275  assess the value of the product, which may include membership
 2276  satisfaction, quality of care, current enrollment or membership,
 2277  coverage areas, accreditation status, premium costs, plan costs,
 2278  premium increases, range of benefits, copayments and
 2279  deductibles, accuracy and speed of claims payment, credentials
 2280  of physicians, number of providers, names of network providers,
 2281  and hospitals in the network. Health plans shall make available
 2282  to the agency any such data or information that is not currently
 2283  reported to the agency or the office.
 2284         3. Determine the method and format for public disclosure of
 2285  data reported pursuant to this paragraph. The agency shall make
 2286  its determination based upon input from the State Consumer
 2287  Health Information and Policy Advisory Council. At a minimum,
 2288  the data shall be made available on the agency’s Internet
 2289  website in a manner that allows consumers to conduct an
 2290  interactive search that allows them to view and compare the
 2291  information for specific providers. The website must include
 2292  such additional information as is determined necessary to ensure
 2293  that the website enhances informed decisionmaking among
 2294  consumers and health care purchasers, which shall include, at a
 2295  minimum, appropriate guidance on how to use the data and an
 2296  explanation of why the data may vary from provider to provider.
 2297         4. Publish on its website undiscounted charges for no fewer
 2298  than 150 of the most commonly performed adult and pediatric
 2299  procedures, including outpatient, inpatient, diagnostic, and
 2300  preventative procedures.
 2301         Section 61. Paragraph (a) of subsection (1) of section
 2302  408.061, Florida Statutes, is amended to read:
 2303         408.061 Data collection; uniform systems of financial
 2304  reporting; information relating to physician charges;
 2305  confidential information; immunity.—
 2306         (1) The agency shall require the submission by health care
 2307  facilities, health care providers, and health insurers of data
 2308  necessary to carry out the agency’s duties. Specifications for
 2309  data to be collected under this section shall be developed by
 2310  the agency with the assistance of technical advisory panels
 2311  including representatives of affected entities, consumers,
 2312  purchasers, and such other interested parties as may be
 2313  determined by the agency.
 2314         (a) Data submitted by health care facilities, including the
 2315  facilities as defined in chapter 395, shall include, but are not
 2316  limited to: case-mix data, patient admission and discharge data,
 2317  hospital emergency department data which shall include the
 2318  number of patients treated in the emergency department of a
 2319  licensed hospital reported by patient acuity level, data on
 2320  hospital-acquired infections as specified by rule, data on
 2321  complications as specified by rule, data on readmissions as
 2322  specified by rule, with patient and provider-specific
 2323  identifiers included, actual charge data by diagnostic groups,
 2324  financial data, accounting data, operating expenses, expenses
 2325  incurred for rendering services to patients who cannot or do not
 2326  pay, interest charges, depreciation expenses based on the
 2327  expected useful life of the property and equipment involved, and
 2328  demographic data. The agency shall adopt nationally recognized
 2329  risk adjustment methodologies or software consistent with the
 2330  standards of the Agency for Healthcare Research and Quality and
 2331  as selected by the agency for all data submitted as required by
 2332  this section. Data may be obtained from documents such as, but
 2333  not limited to: leases, contracts, debt instruments, itemized
 2334  patient bills, medical record abstracts, and related diagnostic
 2335  information. Reported data elements shall be reported
 2336  electronically and in accordance with rule 59E-7.012, Florida
 2337  Administrative Code. Data submitted shall be certified by the
 2338  chief executive officer or an appropriate and duly authorized
 2339  representative or employee of the licensed facility that the
 2340  information submitted is true and accurate.
 2341         Section 62. Subsection (43) of section 408.07, Florida
 2342  Statutes, is amended to read:
 2343         408.07 Definitions.—As used in this chapter, with the
 2344  exception of ss. 408.031-408.045, the term:
 2345         (43) “Rural hospital” means an acute care hospital licensed
 2346  under chapter 395, having 100 or fewer licensed beds and an
 2347  emergency room, and which is:
 2348         (a) The sole provider within a county with a population
 2349  density of no greater than 100 persons per square mile;
 2350         (b) An acute care hospital, in a county with a population
 2351  density of no greater than 100 persons per square mile, which is
 2352  at least 30 minutes of travel time, on normally traveled roads
 2353  under normal traffic conditions, from another acute care
 2354  hospital within the same county;
 2355         (c) A hospital supported by a tax district or subdistrict
 2356  whose boundaries encompass a population of 100 persons or fewer
 2357  per square mile;
 2358         (d) A hospital with a service area that has a population of
 2359  100 persons or fewer per square mile. As used in this paragraph,
 2360  the term “service area” means the fewest number of zip codes
 2361  that account for 75 percent of the hospital’s discharges for the
 2362  most recent 5-year period, based on information available from
 2363  the hospital inpatient discharge database in the Florida Center
 2364  for Health Information and Policy Analysis at the Agency for
 2365  Health Care Administration; or
 2366         (e) A critical access hospital.
 2367  
 2368  Population densities used in this subsection must be based upon
 2369  the most recently completed United States census. A hospital
 2370  that received funds under s. 409.9116 for a quarter beginning no
 2371  later than July 1, 2002, is deemed to have been and shall
 2372  continue to be a rural hospital from that date through June 30,
 2373  2015, if the hospital continues to have 100 or fewer licensed
 2374  beds and an emergency room, or meets the criteria of s.
 2375  395.602(2)(e)4. An acute care hospital that has not previously
 2376  been designated as a rural hospital and that meets the criteria
 2377  of this subsection shall be granted such designation upon
 2378  application, including supporting documentation, to the Agency
 2379  for Health Care Administration.
 2380         Section 63. Section 408.10, Florida Statutes, is amended to
 2381  read:
 2382         408.10 Consumer complaints.—The agency shall:
 2383         (1) publish and make available to the public a toll-free
 2384  telephone number for the purpose of handling consumer complaints
 2385  and shall serve as a liaison between consumer entities and other
 2386  private entities and governmental entities for the disposition
 2387  of problems identified by consumers of health care.
 2388         (2) Be empowered to investigate consumer complaints
 2389  relating to problems with health care facilities’ billing
 2390  practices and issue reports to be made public in any cases where
 2391  the agency determines the health care facility has engaged in
 2392  billing practices which are unreasonable and unfair to the
 2393  consumer.
 2394         Section 64. Subsections (12) through (30) of section
 2395  408.802, Florida Statutes, are renumbered as subsections (11)
 2396  through (29), respectively, and present subsection (11) of that
 2397  section is amended to read:
 2398         408.802 Applicability.—The provisions of this part apply to
 2399  the provision of services that require licensure as defined in
 2400  this part and to the following entities licensed, registered, or
 2401  certified by the agency, as described in chapters 112, 383, 390,
 2402  394, 395, 400, 429, 440, 483, and 765:
 2403         (11) Private review agents, as provided under part I of
 2404  chapter 395.
 2405         Section 65. Subsection (3) is added to section 408.804,
 2406  Florida Statutes, to read:
 2407         408.804 License required; display.—
 2408         (3) Any person who knowingly alters, defaces, or falsifies
 2409  a license certificate issued by the agency, or causes or
 2410  procures any person to commit such an offense, commits a
 2411  misdemeanor of the second degree, punishable as provided in s.
 2412  775.082 or s 775.083. Any licensee or provider who displays an
 2413  altered, defaced, or falsified license certificate is subject to
 2414  the penalties set forth in s. 408.815 and an administrative fine
 2415  of $1,000 for each day of illegal display.
 2416         Section 66. Paragraph (d) of subsection (2) of section
 2417  408.806, Florida Statutes, is amended, to read:
 2418         408.806 License application process.—
 2419         (2)
 2420         (d) The agency shall notify the licensee by mail or
 2421  electronically at least 90 days before the expiration of a
 2422  license that a renewal license is necessary to continue
 2423  operation. The licensee’s failure to timely file submit a
 2424  renewal application and license application fee with the agency
 2425  shall result in a $50 per day late fee charged to the licensee
 2426  by the agency; however, the aggregate amount of the late fee may
 2427  not exceed 50 percent of the licensure fee or $500, whichever is
 2428  less. The agency shall provide a courtesy notice to the licensee
 2429  by United States mail, electronically, or by any other manner at
 2430  its address of record or mailing address, if provided, at least
 2431  90 days prior to the expiration of a license informing the
 2432  licensee of the expiration of the license. If the licensee does
 2433  not receive the courtesy notice, the licensee continues to be
 2434  legally obligated to timely file the renewal application and
 2435  license application fee with the agency and is not excused from
 2436  the payment of a late fee. If an application is received after
 2437  the required filing date and exhibits a hand-canceled postmark
 2438  obtained from a United States post office dated on or before the
 2439  required filing date, no fine will be levied. Payment of the
 2440  late fee is required in order for a late application to be
 2441  considered complete, and failure to pay the late fee is
 2442  considered an omission from the application.
 2443         Section 67. Paragraph (b) of subsection (1) of section
 2444  408.8065, Florida Statutes, is amended to read:
 2445         408.8065 Additional licensure requirements for home health
 2446  agencies, home medical equipment providers, and health care
 2447  clinics.—
 2448         (1) An applicant for initial licensure, or initial
 2449  licensure due to a change of ownership, as a home health agency,
 2450  home medical equipment provider, or health care clinic shall:
 2451         (b) Submit projected pro forma financial statements,
 2452  including a balance sheet, income and expense statement, and a
 2453  statement of cash flows for the first 2 years of operation which
 2454  provide evidence that the applicant has sufficient assets,
 2455  credit, and projected revenues to cover liabilities and
 2456  expenses.
 2457  
 2458  All documents required under this subsection must be prepared in
 2459  accordance with generally accepted accounting principles and may
 2460  be in a compilation form. The financial statements must be
 2461  signed by a certified public accountant.
 2462         Section 68. Subsections (4) through (8) of section 408.809,
 2463  Florida Statutes, are amended to read:
 2464         408.809 Background screening; prohibited offenses.—
 2465         (4) In addition to the offenses listed in s. 435.04, all
 2466  persons required to undergo background screening pursuant to
 2467  this part or authorizing statutes must not have an arrest
 2468  awaiting final disposition for, must not have been found guilty
 2469  of, regardless of adjudication, or entered a plea of nolo
 2470  contendere or guilty to, and must not have been adjudicated
 2471  delinquent and the record not have been sealed or expunged for
 2472  any of the following offenses or any similar offense of another
 2473  jurisdiction:
 2474         (a) Any authorizing statutes, if the offense was a felony.
 2475         (b) This chapter, if the offense was a felony.
 2476         (c) Section 409.920, relating to Medicaid provider fraud.
 2477         (d) Section 409.9201, relating to Medicaid fraud.
 2478         (e) Section 741.28, relating to domestic violence.
 2479         (f) Section 817.034, relating to fraudulent acts through
 2480  mail, wire, radio, electromagnetic, photoelectronic, or
 2481  photooptical systems.
 2482         (g) Section 817.234, relating to false and fraudulent
 2483  insurance claims.
 2484         (h) Section 817.505, relating to patient brokering.
 2485         (i) Section 817.568, relating to criminal use of personal
 2486  identification information.
 2487         (j) Section 817.60, relating to obtaining a credit card
 2488  through fraudulent means.
 2489         (k) Section 817.61, relating to fraudulent use of credit
 2490  cards, if the offense was a felony.
 2491         (l) Section 831.01, relating to forgery.
 2492         (m) Section 831.02, relating to uttering forged
 2493  instruments.
 2494         (n) Section 831.07, relating to forging bank bills, checks,
 2495  drafts, or promissory notes.
 2496         (o) Section 831.09, relating to uttering forged bank bills,
 2497  checks, drafts, or promissory notes.
 2498         (p) Section 831.30, relating to fraud in obtaining
 2499  medicinal drugs.
 2500         (q) Section 831.31, relating to the sale, manufacture,
 2501  delivery, or possession with the intent to sell, manufacture, or
 2502  deliver any counterfeit controlled substance, if the offense was
 2503  a felony.
 2504         (5) A person who serves as a controlling interest of, is
 2505  employed by, or contracts with a licensee on July 31, 2010, who
 2506  has been screened and qualified according to standards specified
 2507  in s. 435.03 or s. 435.04 must be rescreened by July 31, 2015,
 2508  in accordance with the schedule provided in this subsection. The
 2509  agency may adopt rules to establish a schedule to stagger the
 2510  implementation of the required rescreening over the 5-year
 2511  period, beginning July 31, 2010, through July 31, 2015. If, upon
 2512  rescreening, such person has a disqualifying offense that was
 2513  not a disqualifying offense at the time of the last screening,
 2514  but is a current disqualifying offense and was committed before
 2515  the last screening, he or she may apply for an exemption from
 2516  the appropriate licensing agency and, if agreed to by the
 2517  employer, may continue to perform his or her duties until the
 2518  licensing agency renders a decision on the application for
 2519  exemption if the person is eligible to apply for an exemption
 2520  and the exemption request is received by the agency within 30
 2521  days after receipt of the rescreening results by the person. The
 2522  rescreening schedule is as follows:
 2523         (a) An individual whose last screening was conducted before
 2524  December 31, 2003, must be rescreened by July 31, 2013;
 2525         (b) An individual whose last screening was conducted
 2526  between January 1, 2004, and December 31, 2007, must be
 2527  rescreened by July 31, 2014; and
 2528         (c) An individual whose last screening was conducted
 2529  between January 1, 2008, and July 31, 2010, must be rescreened
 2530  by July 31, 2015.
 2531         (6)(5) The costs associated with obtaining the required
 2532  screening must be borne by the licensee or the person subject to
 2533  screening. Licensees may reimburse persons for these costs. The
 2534  Department of Law Enforcement shall charge the agency for
 2535  screening pursuant to s. 943.053(3). The agency shall establish
 2536  a schedule of fees to cover the costs of screening.
 2537         (7)(6)(a) As provided in chapter 435, the agency may grant
 2538  an exemption from disqualification to a person who is subject to
 2539  this section and who:
 2540         1. Does not have an active professional license or
 2541  certification from the Department of Health; or
 2542         2. Has an active professional license or certification from
 2543  the Department of Health but is not providing a service within
 2544  the scope of that license or certification.
 2545         (b) As provided in chapter 435, the appropriate regulatory
 2546  board within the Department of Health, or the department itself
 2547  if there is no board, may grant an exemption from
 2548  disqualification to a person who is subject to this section and
 2549  who has received a professional license or certification from
 2550  the Department of Health or a regulatory board within that
 2551  department and that person is providing a service within the
 2552  scope of his or her licensed or certified practice.
 2553         (8)(7) The agency and the Department of Health may adopt
 2554  rules pursuant to ss. 120.536(1) and 120.54 to implement this
 2555  section, chapter 435, and authorizing statutes requiring
 2556  background screening and to implement and adopt criteria
 2557  relating to retaining fingerprints pursuant to s. 943.05(2).
 2558         (9)(8) There is no unemployment compensation or other
 2559  monetary liability on the part of, and no cause of action for
 2560  damages arising against, an employer that, upon notice of a
 2561  disqualifying offense listed under chapter 435 or this section,
 2562  terminates the person against whom the report was issued,
 2563  whether or not that person has filed for an exemption with the
 2564  Department of Health or the agency.
 2565         Section 69. Subsection (3) is added to section 408.813,
 2566  Florida Statutes, to read:
 2567         408.813 Administrative fines; violations.—As a penalty for
 2568  any violation of this part, authorizing statutes, or applicable
 2569  rules, the agency may impose an administrative fine.
 2570         (3) The agency may impose an administrative fine for a
 2571  violation that is not designated as a class I, class II, class
 2572  III, or class IV violation. Unless otherwise specified by law,
 2573  the amount of the fine shall not exceed $500 for each violation.
 2574  Unclassified violations may include:
 2575         (a) Violating any term or condition of a license.
 2576         (b) Violating any provision of this part, authorizing
 2577  statutes, or applicable rules.
 2578         (c) Exceeding licensed capacity.
 2579         (d) Providing services beyond the scope of the license.
 2580         (e) Violating a moratorium imposed pursuant to s. 408.814.
 2581         Section 70. Subsection (5) is added to section 408.815,
 2582  Florida Statutes, to read:
 2583         408.815 License or application denial; revocation.—
 2584         (5) In order to ensure the health, safety, and welfare of
 2585  clients when a license has been denied, revoked, or is set to
 2586  terminate, the agency may extend the license expiration date for
 2587  a period of up to 30 days for the sole purpose of allowing the
 2588  safe and orderly discharge of clients. The agency may impose
 2589  conditions on the extension, including, but not limited to,
 2590  prohibiting or limiting admissions, expedited discharge
 2591  planning, required status reports, and mandatory monitoring by
 2592  the agency or third parties. When imposing these conditions, the
 2593  agency shall take into consideration the nature and number of
 2594  clients, the availability and location of acceptable alternative
 2595  placements, and the ability of the licensee to continue
 2596  providing care to the clients. The agency may terminate the
 2597  extension or modify the conditions at any time. This authority
 2598  is in addition to any other authority granted to the agency
 2599  under chapter 120, this part, and authorizing statutes but
 2600  creates no right or entitlement to an extension of a license
 2601  expiration date.
 2602         Section 71. Subsection (1) of section 409.91196, Florida
 2603  Statutes, is amended to read:
 2604         409.91196 Supplemental rebate agreements; public records
 2605  and public meetings exemption.—
 2606         (1) The rebate amount, percent of rebate, manufacturer’s
 2607  pricing, and supplemental rebate, and other trade secrets as
 2608  defined in s. 688.002 that the agency has identified for use in
 2609  negotiations, held by the Agency for Health Care Administration
 2610  under s. 409.912(39)(a)8.7. are confidential and exempt from s.
 2611  119.07(1) and s. 24(a), Art. I of the State Constitution.
 2612         Section 72. Paragraph (a) of subsection (39) of section
 2613  409.912, Florida Statutes, is amended to read:
 2614         409.912 Cost-effective purchasing of health care.—The
 2615  agency shall purchase goods and services for Medicaid recipients
 2616  in the most cost-effective manner consistent with the delivery
 2617  of quality medical care. To ensure that medical services are
 2618  effectively utilized, the agency may, in any case, require a
 2619  confirmation or second physician’s opinion of the correct
 2620  diagnosis for purposes of authorizing future services under the
 2621  Medicaid program. This section does not restrict access to
 2622  emergency services or poststabilization care services as defined
 2623  in 42 C.F.R. part 438.114. Such confirmation or second opinion
 2624  shall be rendered in a manner approved by the agency. The agency
 2625  shall maximize the use of prepaid per capita and prepaid
 2626  aggregate fixed-sum basis services when appropriate and other
 2627  alternative service delivery and reimbursement methodologies,
 2628  including competitive bidding pursuant to s. 287.057, designed
 2629  to facilitate the cost-effective purchase of a case-managed
 2630  continuum of care. The agency shall also require providers to
 2631  minimize the exposure of recipients to the need for acute
 2632  inpatient, custodial, and other institutional care and the
 2633  inappropriate or unnecessary use of high-cost services. The
 2634  agency shall contract with a vendor to monitor and evaluate the
 2635  clinical practice patterns of providers in order to identify
 2636  trends that are outside the normal practice patterns of a
 2637  provider’s professional peers or the national guidelines of a
 2638  provider’s professional association. The vendor must be able to
 2639  provide information and counseling to a provider whose practice
 2640  patterns are outside the norms, in consultation with the agency,
 2641  to improve patient care and reduce inappropriate utilization.
 2642  The agency may mandate prior authorization, drug therapy
 2643  management, or disease management participation for certain
 2644  populations of Medicaid beneficiaries, certain drug classes, or
 2645  particular drugs to prevent fraud, abuse, overuse, and possible
 2646  dangerous drug interactions. The Pharmaceutical and Therapeutics
 2647  Committee shall make recommendations to the agency on drugs for
 2648  which prior authorization is required. The agency shall inform
 2649  the Pharmaceutical and Therapeutics Committee of its decisions
 2650  regarding drugs subject to prior authorization. The agency is
 2651  authorized to limit the entities it contracts with or enrolls as
 2652  Medicaid providers by developing a provider network through
 2653  provider credentialing. The agency may competitively bid single
 2654  source-provider contracts if procurement of goods or services
 2655  results in demonstrated cost savings to the state without
 2656  limiting access to care. The agency may limit its network based
 2657  on the assessment of beneficiary access to care, provider
 2658  availability, provider quality standards, time and distance
 2659  standards for access to care, the cultural competence of the
 2660  provider network, demographic characteristics of Medicaid
 2661  beneficiaries, practice and provider-to-beneficiary standards,
 2662  appointment wait times, beneficiary use of services, provider
 2663  turnover, provider profiling, provider licensure history,
 2664  previous program integrity investigations and findings, peer
 2665  review, provider Medicaid policy and billing compliance records,
 2666  clinical and medical record audits, and other factors. Providers
 2667  shall not be entitled to enrollment in the Medicaid provider
 2668  network. The agency shall determine instances in which allowing
 2669  Medicaid beneficiaries to purchase durable medical equipment and
 2670  other goods is less expensive to the Medicaid program than long
 2671  term rental of the equipment or goods. The agency may establish
 2672  rules to facilitate purchases in lieu of long-term rentals in
 2673  order to protect against fraud and abuse in the Medicaid program
 2674  as defined in s. 409.913. The agency may seek federal waivers
 2675  necessary to administer these policies.
 2676         (39)(a) The agency shall implement a Medicaid prescribed
 2677  drug spending-control program that includes the following
 2678  components:
 2679         1. A Medicaid preferred drug list, which shall be a listing
 2680  of cost-effective therapeutic options recommended by the
 2681  Medicaid Pharmacy and Therapeutics Committee established
 2682  pursuant to s. 409.91195 and adopted by the agency for each
 2683  therapeutic class on the preferred drug list. At the discretion
 2684  of the committee, and when feasible, the preferred drug list
 2685  should include at least two products in a therapeutic class. The
 2686  agency may post the preferred drug list and updates to the
 2687  preferred drug list on an Internet website without following the
 2688  rulemaking procedures of chapter 120. Antiretroviral agents are
 2689  excluded from the preferred drug list. The agency shall also
 2690  limit the amount of a prescribed drug dispensed to no more than
 2691  a 34-day supply unless the drug products’ smallest marketed
 2692  package is greater than a 34-day supply, or the drug is
 2693  determined by the agency to be a maintenance drug in which case
 2694  a 100-day maximum supply may be authorized. The agency is
 2695  authorized to seek any federal waivers necessary to implement
 2696  these cost-control programs and to continue participation in the
 2697  federal Medicaid rebate program, or alternatively to negotiate
 2698  state-only manufacturer rebates. The agency may adopt rules to
 2699  implement this subparagraph. The agency shall continue to
 2700  provide unlimited contraceptive drugs and items. The agency must
 2701  establish procedures to ensure that:
 2702         a. There is a response to a request for prior consultation
 2703  by telephone or other telecommunication device within 24 hours
 2704  after receipt of a request for prior consultation; and
 2705         b. A 72-hour supply of the drug prescribed is provided in
 2706  an emergency or when the agency does not provide a response
 2707  within 24 hours as required by sub-subparagraph a.
 2708         2. Reimbursement to pharmacies for Medicaid prescribed
 2709  drugs shall be set at the lesser of: the average wholesale price
 2710  (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
 2711  plus 4.75 percent, the federal upper limit (FUL), the state
 2712  maximum allowable cost (SMAC), or the usual and customary (UAC)
 2713  charge billed by the provider.
 2714         3. For a prescribed drug billed as a 340B prescribed
 2715  medication, the claim must meet the requirements of the Deficit
 2716  Reduction Act of 2005 and the federal 340B program, contain a
 2717  national drug code, and be billed at the actual acquisition cost
 2718  or payment shall be denied.
 2719         4.3. The agency shall develop and implement a process for
 2720  managing the drug therapies of Medicaid recipients who are using
 2721  significant numbers of prescribed drugs each month. The
 2722  management process may include, but is not limited to,
 2723  comprehensive, physician-directed medical-record reviews, claims
 2724  analyses, and case evaluations to determine the medical
 2725  necessity and appropriateness of a patient’s treatment plan and
 2726  drug therapies. The agency may contract with a private
 2727  organization to provide drug-program-management services. The
 2728  Medicaid drug benefit management program shall include
 2729  initiatives to manage drug therapies for HIV/AIDS patients,
 2730  patients using 20 or more unique prescriptions in a 180-day
 2731  period, and the top 1,000 patients in annual spending. The
 2732  agency shall enroll any Medicaid recipient in the drug benefit
 2733  management program if he or she meets the specifications of this
 2734  provision and is not enrolled in a Medicaid health maintenance
 2735  organization.
 2736         5.4. The agency may limit the size of its pharmacy network
 2737  based on need, competitive bidding, price negotiations,
 2738  credentialing, or similar criteria. The agency shall give
 2739  special consideration to rural areas in determining the size and
 2740  location of pharmacies included in the Medicaid pharmacy
 2741  network. A pharmacy credentialing process may include criteria
 2742  such as a pharmacy’s full-service status, location, size,
 2743  patient educational programs, patient consultation, disease
 2744  management services, and other characteristics. The agency may
 2745  impose a moratorium on Medicaid pharmacy enrollment when it is
 2746  determined that it has a sufficient number of Medicaid
 2747  participating providers. The agency must allow dispensing
 2748  practitioners to participate as a part of the Medicaid pharmacy
 2749  network regardless of the practitioner’s proximity to any other
 2750  entity that is dispensing prescription drugs under the Medicaid
 2751  program. A dispensing practitioner must meet all credentialing
 2752  requirements applicable to his or her practice, as determined by
 2753  the agency.
 2754         6.5. The agency shall develop and implement a program that
 2755  requires Medicaid practitioners who prescribe drugs to use a
 2756  counterfeit-proof prescription pad for Medicaid prescriptions.
 2757  The agency shall require the use of standardized counterfeit
 2758  proof prescription pads by Medicaid-participating prescribers or
 2759  prescribers who write prescriptions for Medicaid recipients. The
 2760  agency may implement the program in targeted geographic areas or
 2761  statewide.
 2762         7.6. The agency may enter into arrangements that require
 2763  manufacturers of generic drugs prescribed to Medicaid recipients
 2764  to provide rebates of at least 15.1 percent of the average
 2765  manufacturer price for the manufacturer’s generic products.
 2766  These arrangements shall require that if a generic-drug
 2767  manufacturer pays federal rebates for Medicaid-reimbursed drugs
 2768  at a level below 15.1 percent, the manufacturer must provide a
 2769  supplemental rebate to the state in an amount necessary to
 2770  achieve a 15.1-percent rebate level.
 2771         8.7. The agency may establish a preferred drug list as
 2772  described in this subsection, and, pursuant to the establishment
 2773  of such preferred drug list, it is authorized to negotiate
 2774  supplemental rebates from manufacturers that are in addition to
 2775  those required by Title XIX of the Social Security Act and at no
 2776  less than 14 percent of the average manufacturer price as
 2777  defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
 2778  the federal or supplemental rebate, or both, equals or exceeds
 2779  29 percent. There is no upper limit on the supplemental rebates
 2780  the agency may negotiate. The agency may determine that specific
 2781  products, brand-name or generic, are competitive at lower rebate
 2782  percentages. Agreement to pay the minimum supplemental rebate
 2783  percentage will guarantee a manufacturer that the Medicaid
 2784  Pharmaceutical and Therapeutics Committee will consider a
 2785  product for inclusion on the preferred drug list. However, a
 2786  pharmaceutical manufacturer is not guaranteed placement on the
 2787  preferred drug list by simply paying the minimum supplemental
 2788  rebate. Agency decisions will be made on the clinical efficacy
 2789  of a drug and recommendations of the Medicaid Pharmaceutical and
 2790  Therapeutics Committee, as well as the price of competing
 2791  products minus federal and state rebates. The agency is
 2792  authorized to contract with an outside agency or contractor to
 2793  conduct negotiations for supplemental rebates. For the purposes
 2794  of this section, the term “supplemental rebates” means cash
 2795  rebates. Effective July 1, 2004, value-added programs as a
 2796  substitution for supplemental rebates are prohibited. The agency
 2797  is authorized to seek any federal waivers to implement this
 2798  initiative.
 2799         9.8. The Agency for Health Care Administration shall expand
 2800  home delivery of pharmacy products. To assist Medicaid patients
 2801  in securing their prescriptions and reduce program costs, the
 2802  agency shall expand its current mail-order-pharmacy diabetes
 2803  supply program to include all generic and brand-name drugs used
 2804  by Medicaid patients with diabetes. Medicaid recipients in the
 2805  current program may obtain nondiabetes drugs on a voluntary
 2806  basis. This initiative is limited to the geographic area covered
 2807  by the current contract. The agency may seek and implement any
 2808  federal waivers necessary to implement this subparagraph.
 2809         10.9. The agency shall limit to one dose per month any drug
 2810  prescribed to treat erectile dysfunction.
 2811         11.10.a. The agency may implement a Medicaid behavioral
 2812  drug management system. The agency may contract with a vendor
 2813  that has experience in operating behavioral drug management
 2814  systems to implement this program. The agency is authorized to
 2815  seek federal waivers to implement this program.
 2816         b. The agency, in conjunction with the Department of
 2817  Children and Family Services, may implement the Medicaid
 2818  behavioral drug management system that is designed to improve
 2819  the quality of care and behavioral health prescribing practices
 2820  based on best practice guidelines, improve patient adherence to
 2821  medication plans, reduce clinical risk, and lower prescribed
 2822  drug costs and the rate of inappropriate spending on Medicaid
 2823  behavioral drugs. The program may include the following
 2824  elements:
 2825         (I) Provide for the development and adoption of best
 2826  practice guidelines for behavioral health-related drugs such as
 2827  antipsychotics, antidepressants, and medications for treating
 2828  bipolar disorders and other behavioral conditions; translate
 2829  them into practice; review behavioral health prescribers and
 2830  compare their prescribing patterns to a number of indicators
 2831  that are based on national standards; and determine deviations
 2832  from best practice guidelines.
 2833         (II) Implement processes for providing feedback to and
 2834  educating prescribers using best practice educational materials
 2835  and peer-to-peer consultation.
 2836         (III) Assess Medicaid beneficiaries who are outliers in
 2837  their use of behavioral health drugs with regard to the numbers
 2838  and types of drugs taken, drug dosages, combination drug
 2839  therapies, and other indicators of improper use of behavioral
 2840  health drugs.
 2841         (IV) Alert prescribers to patients who fail to refill
 2842  prescriptions in a timely fashion, are prescribed multiple same
 2843  class behavioral health drugs, and may have other potential
 2844  medication problems.
 2845         (V) Track spending trends for behavioral health drugs and
 2846  deviation from best practice guidelines.
 2847         (VI) Use educational and technological approaches to
 2848  promote best practices, educate consumers, and train prescribers
 2849  in the use of practice guidelines.
 2850         (VII) Disseminate electronic and published materials.
 2851         (VIII) Hold statewide and regional conferences.
 2852         (IX) Implement a disease management program with a model
 2853  quality-based medication component for severely mentally ill
 2854  individuals and emotionally disturbed children who are high
 2855  users of care.
 2856         12.11.a. The agency shall implement a Medicaid prescription
 2857  drug management system. The agency may contract with a vendor
 2858  that has experience in operating prescription drug management
 2859  systems in order to implement this system. Any management system
 2860  that is implemented in accordance with this subparagraph must
 2861  rely on cooperation between physicians and pharmacists to
 2862  determine appropriate practice patterns and clinical guidelines
 2863  to improve the prescribing, dispensing, and use of drugs in the
 2864  Medicaid program. The agency may seek federal waivers to
 2865  implement this program.
 2866         b. The drug management system must be designed to improve
 2867  the quality of care and prescribing practices based on best
 2868  practice guidelines, improve patient adherence to medication
 2869  plans, reduce clinical risk, and lower prescribed drug costs and
 2870  the rate of inappropriate spending on Medicaid prescription
 2871  drugs. The program must:
 2872         (I) Provide for the development and adoption of best
 2873  practice guidelines for the prescribing and use of drugs in the
 2874  Medicaid program, including translating best practice guidelines
 2875  into practice; reviewing prescriber patterns and comparing them
 2876  to indicators that are based on national standards and practice
 2877  patterns of clinical peers in their community, statewide, and
 2878  nationally; and determine deviations from best practice
 2879  guidelines.
 2880         (II) Implement processes for providing feedback to and
 2881  educating prescribers using best practice educational materials
 2882  and peer-to-peer consultation.
 2883         (III) Assess Medicaid recipients who are outliers in their
 2884  use of a single or multiple prescription drugs with regard to
 2885  the numbers and types of drugs taken, drug dosages, combination
 2886  drug therapies, and other indicators of improper use of
 2887  prescription drugs.
 2888         (IV) Alert prescribers to patients who fail to refill
 2889  prescriptions in a timely fashion, are prescribed multiple drugs
 2890  that may be redundant or contraindicated, or may have other
 2891  potential medication problems.
 2892         (V) Track spending trends for prescription drugs and
 2893  deviation from best practice guidelines.
 2894         (VI) Use educational and technological approaches to
 2895  promote best practices, educate consumers, and train prescribers
 2896  in the use of practice guidelines.
 2897         (VII) Disseminate electronic and published materials.
 2898         (VIII) Hold statewide and regional conferences.
 2899         (IX) Implement disease management programs in cooperation
 2900  with physicians and pharmacists, along with a model quality
 2901  based medication component for individuals having chronic
 2902  medical conditions.
 2903         13.12. The agency is authorized to contract for drug rebate
 2904  administration, including, but not limited to, calculating
 2905  rebate amounts, invoicing manufacturers, negotiating disputes
 2906  with manufacturers, and maintaining a database of rebate
 2907  collections.
 2908         14.13. The agency may specify the preferred daily dosing
 2909  form or strength for the purpose of promoting best practices
 2910  with regard to the prescribing of certain drugs as specified in
 2911  the General Appropriations Act and ensuring cost-effective
 2912  prescribing practices.
 2913         15.14. The agency may require prior authorization for
 2914  Medicaid-covered prescribed drugs. The agency may, but is not
 2915  required to, prior-authorize the use of a product:
 2916         a. For an indication not approved in labeling;
 2917         b. To comply with certain clinical guidelines; or
 2918         c. If the product has the potential for overuse, misuse, or
 2919  abuse.
 2920  
 2921  The agency may require the prescribing professional to provide
 2922  information about the rationale and supporting medical evidence
 2923  for the use of a drug. The agency may post prior authorization
 2924  criteria and protocol and updates to the list of drugs that are
 2925  subject to prior authorization on an Internet website without
 2926  amending its rule or engaging in additional rulemaking.
 2927         16.15. The agency, in conjunction with the Pharmaceutical
 2928  and Therapeutics Committee, may require age-related prior
 2929  authorizations for certain prescribed drugs. The agency may
 2930  preauthorize the use of a drug for a recipient who may not meet
 2931  the age requirement or may exceed the length of therapy for use
 2932  of this product as recommended by the manufacturer and approved
 2933  by the Food and Drug Administration. Prior authorization may
 2934  require the prescribing professional to provide information
 2935  about the rationale and supporting medical evidence for the use
 2936  of a drug.
 2937         17.16. The agency shall implement a step-therapy prior
 2938  authorization approval process for medications excluded from the
 2939  preferred drug list. Medications listed on the preferred drug
 2940  list must be used within the previous 12 months prior to the
 2941  alternative medications that are not listed. The step-therapy
 2942  prior authorization may require the prescriber to use the
 2943  medications of a similar drug class or for a similar medical
 2944  indication unless contraindicated in the Food and Drug
 2945  Administration labeling. The trial period between the specified
 2946  steps may vary according to the medical indication. The step
 2947  therapy approval process shall be developed in accordance with
 2948  the committee as stated in s. 409.91195(7) and (8). A drug
 2949  product may be approved without meeting the step-therapy prior
 2950  authorization criteria if the prescribing physician provides the
 2951  agency with additional written medical or clinical documentation
 2952  that the product is medically necessary because:
 2953         a. There is not a drug on the preferred drug list to treat
 2954  the disease or medical condition which is an acceptable clinical
 2955  alternative;
 2956         b. The alternatives have been ineffective in the treatment
 2957  of the beneficiary’s disease; or
 2958         c. Based on historic evidence and known characteristics of
 2959  the patient and the drug, the drug is likely to be ineffective,
 2960  or the number of doses have been ineffective.
 2961  
 2962  The agency shall work with the physician to determine the best
 2963  alternative for the patient. The agency may adopt rules waiving
 2964  the requirements for written clinical documentation for specific
 2965  drugs in limited clinical situations.
 2966         18.17. The agency shall implement a return and reuse
 2967  program for drugs dispensed by pharmacies to institutional
 2968  recipients, which includes payment of a $5 restocking fee for
 2969  the implementation and operation of the program. The return and
 2970  reuse program shall be implemented electronically and in a
 2971  manner that promotes efficiency. The program must permit a
 2972  pharmacy to exclude drugs from the program if it is not
 2973  practical or cost-effective for the drug to be included and must
 2974  provide for the return to inventory of drugs that cannot be
 2975  credited or returned in a cost-effective manner. The agency
 2976  shall determine if the program has reduced the amount of
 2977  Medicaid prescription drugs which are destroyed on an annual
 2978  basis and if there are additional ways to ensure more
 2979  prescription drugs are not destroyed which could safely be
 2980  reused. The agency’s conclusion and recommendations shall be
 2981  reported to the Legislature by December 1, 2005.
 2982         Section 73. Subsections (3) and (4) of section 429.07,
 2983  Florida Statutes, are amended, and subsections (6) and (7) are
 2984  added to that section, to read:
 2985         429.07 License required; fee; inspections.—
 2986         (3) In addition to the requirements of s. 408.806, each
 2987  license granted by the agency must state the type of care for
 2988  which the license is granted. Licenses shall be issued for one
 2989  or more of the following categories of care: standard, extended
 2990  congregate care, limited nursing services, or limited mental
 2991  health.
 2992         (a) A standard license shall be issued to a facility
 2993  facilities providing one or more of the personal services
 2994  identified in s. 429.02. Such licensee facilities may also
 2995  employ or contract with a person licensed under part I of
 2996  chapter 464 to administer medications and perform other tasks as
 2997  specified in s. 429.255.
 2998         (b) An extended congregate care license shall be issued to
 2999  a licensee facilities providing, directly or through contract,
 3000  services beyond those authorized in paragraph (a), including
 3001  services performed by persons licensed under part I of chapter
 3002  464 and supportive services, as defined by rule, to persons who
 3003  would otherwise be disqualified from continued residence in a
 3004  facility licensed under this part.
 3005         1. In order for extended congregate care services to be
 3006  provided, the agency must first determine that all requirements
 3007  established in law and rule are met and must specifically
 3008  designate, on the facility’s license, that such services may be
 3009  provided and whether the designation applies to all or part of
 3010  the facility. Such designation may be made at the time of
 3011  initial licensure or relicensure, or upon request in writing by
 3012  a licensee under this part and part II of chapter 408. The
 3013  notification of approval or the denial of the request shall be
 3014  made in accordance with part II of chapter 408. An existing
 3015  licensee facilities qualifying to provide extended congregate
 3016  care services must have maintained a standard license and may
 3017  not have been subject to administrative sanctions during the
 3018  previous 2 years, or since initial licensure if the facility has
 3019  been licensed for less than 2 years, for any of the following
 3020  reasons:
 3021         a. A class I or class II violation;
 3022         b. Three or more repeat or recurring class III violations
 3023  of identical or similar resident care standards from which a
 3024  pattern of noncompliance is found by the agency;
 3025         c. Three or more class III violations that were not
 3026  corrected in accordance with the corrective action plan approved
 3027  by the agency;
 3028         d. Violation of resident care standards which results in
 3029  requiring the facility to employ the services of a consultant
 3030  pharmacist or consultant dietitian;
 3031         e. Denial, suspension, or revocation of a license for
 3032  another facility licensed under this part in which the applicant
 3033  for an extended congregate care license has at least 25 percent
 3034  ownership interest; or
 3035         f. Imposition of a moratorium pursuant to this part or part
 3036  II of chapter 408 or initiation of injunctive proceedings.
 3037         2. A facility that is licensed to provide extended
 3038  congregate care services shall maintain a written progress
 3039  report for on each person who receives services which describes
 3040  the type, amount, duration, scope, and outcome of services that
 3041  are rendered and the general status of the resident’s health. A
 3042  registered nurse, or appropriate designee, representing the
 3043  agency shall visit the facility at least quarterly to monitor
 3044  residents who are receiving extended congregate care services
 3045  and to determine if the facility is in compliance with this
 3046  part, part II of chapter 408, and relevant rules. One of the
 3047  visits may be in conjunction with the regular survey. The
 3048  monitoring visits may be provided through contractual
 3049  arrangements with appropriate community agencies. A registered
 3050  nurse shall serve as part of the team that inspects the
 3051  facility. The agency may waive one of the required yearly
 3052  monitoring visits for a facility that has been licensed for at
 3053  least 24 months to provide extended congregate care services,
 3054  if, during the inspection, the registered nurse determines that
 3055  extended congregate care services are being provided
 3056  appropriately, and if the facility has no class I or class II
 3057  violations and no uncorrected class III violations. The agency
 3058  must first consult with the long-term care ombudsman council for
 3059  the area in which the facility is located to determine if any
 3060  complaints have been made and substantiated about the quality of
 3061  services or care. The agency may not waive one of the required
 3062  yearly monitoring visits if complaints have been made and
 3063  substantiated.
 3064         3. A facility that is licensed to provide extended
 3065  congregate care services must:
 3066         a. Demonstrate the capability to meet unanticipated
 3067  resident service needs.
 3068         b. Offer a physical environment that promotes a homelike
 3069  setting, provides for resident privacy, promotes resident
 3070  independence, and allows sufficient congregate space as defined
 3071  by rule.
 3072         c. Have sufficient staff available, taking into account the
 3073  physical plant and firesafety features of the building, to
 3074  assist with the evacuation of residents in an emergency.
 3075         d. Adopt and follow policies and procedures that maximize
 3076  resident independence, dignity, choice, and decisionmaking to
 3077  permit residents to age in place, so that moves due to changes
 3078  in functional status are minimized or avoided.
 3079         e. Allow residents or, if applicable, a resident’s
 3080  representative, designee, surrogate, guardian, or attorney in
 3081  fact to make a variety of personal choices, participate in
 3082  developing service plans, and share responsibility in
 3083  decisionmaking.
 3084         f. Implement the concept of managed risk.
 3085         g. Provide, directly or through contract, the services of a
 3086  person licensed under part I of chapter 464.
 3087         h. In addition to the training mandated in s. 429.52,
 3088  provide specialized training as defined by rule for facility
 3089  staff.
 3090         4. A facility that is licensed to provide extended
 3091  congregate care services is exempt from the criteria for
 3092  continued residency set forth in rules adopted under s. 429.41.
 3093  A licensed facility must adopt its own requirements within
 3094  guidelines for continued residency set forth by rule. However,
 3095  the facility may not serve residents who require 24-hour nursing
 3096  supervision. A licensed facility that provides extended
 3097  congregate care services must also provide each resident with a
 3098  written copy of facility policies governing admission and
 3099  retention.
 3100         5. The primary purpose of extended congregate care services
 3101  is to allow residents, as they become more impaired, the option
 3102  of remaining in a familiar setting from which they would
 3103  otherwise be disqualified for continued residency. A facility
 3104  licensed to provide extended congregate care services may also
 3105  admit an individual who exceeds the admission criteria for a
 3106  facility with a standard license, if the individual is
 3107  determined appropriate for admission to the extended congregate
 3108  care facility.
 3109         6. Before the admission of an individual to a facility
 3110  licensed to provide extended congregate care services, the
 3111  individual must undergo a medical examination as provided in s.
 3112  429.26(4) and the facility must develop a preliminary service
 3113  plan for the individual.
 3114         7. When a licensee facility can no longer provide or
 3115  arrange for services in accordance with the resident’s service
 3116  plan and needs and the licensee’s facility’s policy, the
 3117  licensee facility shall make arrangements for relocating the
 3118  person in accordance with s. 429.28(1)(k).
 3119         8. Failure to provide extended congregate care services may
 3120  result in denial of extended congregate care license renewal.
 3121         (c) A limited nursing services license shall be issued to a
 3122  facility that provides services beyond those authorized in
 3123  paragraph (a) and as specified in this paragraph.
 3124         1. In order for limited nursing services to be provided in
 3125  a facility licensed under this part, the agency must first
 3126  determine that all requirements established in law and rule are
 3127  met and must specifically designate, on the facility’s license,
 3128  that such services may be provided. Such designation may be made
 3129  at the time of initial licensure or relicensure, or upon request
 3130  in writing by a licensee under this part and part II of chapter
 3131  408. Notification of approval or denial of such request shall be
 3132  made in accordance with part II of chapter 408. Existing
 3133  facilities qualifying to provide limited nursing services shall
 3134  have maintained a standard license and may not have been subject
 3135  to administrative sanctions that affect the health, safety, and
 3136  welfare of residents for the previous 2 years or since initial
 3137  licensure if the facility has been licensed for less than 2
 3138  years.
 3139         2. Facilities that are licensed to provide limited nursing
 3140  services shall maintain a written progress report on each person
 3141  who receives such nursing services, which report describes the
 3142  type, amount, duration, scope, and outcome of services that are
 3143  rendered and the general status of the resident’s health. A
 3144  registered nurse representing the agency shall visit such
 3145  facilities at least twice a year to monitor residents who are
 3146  receiving limited nursing services and to determine if the
 3147  facility is in compliance with applicable provisions of this
 3148  part, part II of chapter 408, and related rules. The monitoring
 3149  visits may be provided through contractual arrangements with
 3150  appropriate community agencies. A registered nurse shall also
 3151  serve as part of the team that inspects such facility.
 3152         3. A person who receives limited nursing services under
 3153  this part must meet the admission criteria established by the
 3154  agency for assisted living facilities. When a resident no longer
 3155  meets the admission criteria for a facility licensed under this
 3156  part, arrangements for relocating the person shall be made in
 3157  accordance with s. 429.28(1)(k), unless the facility is licensed
 3158  to provide extended congregate care services.
 3159         (4) In accordance with s. 408.805, an applicant or licensee
 3160  shall pay a fee for each license application submitted under
 3161  this part, part II of chapter 408, and applicable rules. The
 3162  amount of the fee shall be established by rule.
 3163         (a) The biennial license fee required of a facility is $300
 3164  per license, with an additional fee of $71 $50 per resident
 3165  based on the total licensed resident capacity of the facility,
 3166  except that no additional fee will be assessed for beds
 3167  designated for recipients of optional state supplementation
 3168  payments provided for in s. 409.212. The total fee may not
 3169  exceed $10,000.
 3170         (b) In addition to the total fee assessed under paragraph
 3171  (a), the agency shall require facilities that are licensed to
 3172  provide extended congregate care services under this part to pay
 3173  an additional fee per licensed facility. The amount of the
 3174  biennial fee shall be $400 per license, with an additional fee
 3175  of $10 per resident based on the total licensed resident
 3176  capacity of the facility.
 3177         (c) In addition to the total fee assessed under paragraph
 3178  (a), the agency shall require facilities that are licensed to
 3179  provide limited nursing services under this part to pay an
 3180  additional fee per licensed facility. The amount of the biennial
 3181  fee shall be $250 per license, with an additional fee of $10 per
 3182  resident based on the total licensed resident capacity of the
 3183  facility.
 3184         (6) In order to determine whether the facility is
 3185  adequately protecting residents’ rights as provided in s.
 3186  429.28, the agency’s standard license survey shall include
 3187  private informal conversations with a sample of residents and
 3188  consultation with the ombudsman council in the planning and
 3189  service area in which the facility is located to discuss
 3190  residents’ experiences within the facility.
 3191         (7) An assisted living facility that has been cited within
 3192  the previous 24-month period for a class I or class II
 3193  violation, regardless of the status of any enforcement or
 3194  disciplinary action, is subject to periodic unannounced
 3195  monitoring to determine if the facility is in compliance with
 3196  this part, part II of chapter 408, and applicable rules.
 3197  Monitoring may occur through a desk review or an onsite
 3198  assessment. If the class I or class II violation relates to
 3199  providing or failing to provide nursing care, a registered nurse
 3200  must participate in monitoring activities during the 12-month
 3201  period following the violation.
 3202         Section 74. Subsection (7) of section 429.11, Florida
 3203  Statutes, is renumbered as subsection (6), and present
 3204  subsection (6) of that section is amended to read:
 3205         429.11 Initial application for license; provisional
 3206  license.—
 3207         (6) In addition to the license categories available in s.
 3208  408.808, a provisional license may be issued to an applicant
 3209  making initial application for licensure or making application
 3210  for a change of ownership. A provisional license shall be
 3211  limited in duration to a specific period of time not to exceed 6
 3212  months, as determined by the agency.
 3213         Section 75. Section 429.12, Florida Statutes, is amended to
 3214  read:
 3215         429.12 Sale or transfer of ownership of a facility.—It is
 3216  the intent of the Legislature to protect the rights of the
 3217  residents of an assisted living facility when the facility is
 3218  sold or the ownership thereof is transferred. Therefore, in
 3219  addition to the requirements of part II of chapter 408, whenever
 3220  a facility is sold or the ownership thereof is transferred,
 3221  including leasing,:
 3222         (1) the transferee shall notify the residents, in writing,
 3223  of the change of ownership within 7 days after receipt of the
 3224  new license.
 3225         (2) The transferor of a facility the license of which is
 3226  denied pending an administrative hearing shall, as a part of the
 3227  written change-of-ownership contract, advise the transferee that
 3228  a plan of correction must be submitted by the transferee and
 3229  approved by the agency at least 7 days before the change of
 3230  ownership and that failure to correct the condition which
 3231  resulted in the moratorium pursuant to part II of chapter 408 or
 3232  denial of licensure is grounds for denial of the transferee’s
 3233  license.
 3234         Section 76. Subsections (1), (4), and (5) of section
 3235  429.17, Florida Statutes, are amended to read:
 3236         429.17 Expiration of license; renewal; conditional
 3237  license.—
 3238         (1) Limited nursing, Extended congregate care, and limited
 3239  mental health licenses shall expire at the same time as the
 3240  facility’s standard license, regardless of when issued.
 3241         (4) In addition to the license categories available in s.
 3242  408.808, a conditional license may be issued to an applicant for
 3243  license renewal if the applicant fails to meet all standards and
 3244  requirements for licensure. A conditional license issued under
 3245  this subsection shall be limited in duration to a specific
 3246  period of time not to exceed 6 months, as determined by the
 3247  agency, and shall be accompanied by an agency-approved plan of
 3248  correction.
 3249         (5) When an extended congregate care or limited nursing
 3250  license is requested during a facility’s biennial license
 3251  period, the fee shall be prorated in order to permit the
 3252  additional license to expire at the end of the biennial license
 3253  period. The fee shall be calculated as of the date the
 3254  additional license application is received by the agency.
 3255         Section 77. Section 429.195, Florida Statutes, is amended
 3256  to read:
 3257         429.195 Rebates prohibited; penalties.—
 3258         (1) It is unlawful for any assisted living facility
 3259  licensed under this part to contract or promise to pay or
 3260  receive any commission, bonus, kickback, or rebate or engage in
 3261  any split-fee arrangement in any form whatsoever with any health
 3262  care provider or health care facility under s. 817.505
 3263  physician, surgeon, organization, agency, or person, either
 3264  directly or indirectly, for residents referred to an assisted
 3265  living facility licensed under this part. A facility may employ
 3266  or contract with persons to market the facility, provided the
 3267  employee or contract provider clearly indicates that he or she
 3268  represents the facility. A person or agency independent of the
 3269  facility may provide placement or referral services for a fee to
 3270  individuals seeking assistance in finding a suitable facility;
 3271  however, any fee paid for placement or referral services must be
 3272  paid by the individual looking for a facility, not by the
 3273  facility.
 3274         (2) A violation of this section shall be considered patient
 3275  brokering and is punishable as provided in s. 817.505.
 3276         (3) This section does not apply to:
 3277         (a)An individual with whom the facility employs or
 3278  contracts with to market the facility if the individual clearly
 3279  indicates that he or she works with or for the facility.
 3280         (b)A referral service that provides information,
 3281  consultation, or referrals to consumers to assist them in
 3282  finding appropriate care or housing options for senior citizens
 3283  or disabled adults if such referred consumers are not Medicaid
 3284  recipients.
 3285         (c) A resident of an assisted living facility who refers to
 3286  the assisted living facility a friend, family member, or other
 3287  individual with whom the resident has a personal relationship,
 3288  and the assisted living facility is not prohibited from
 3289  providing a monetary reward to the resident for making such a
 3290  referral.
 3291         Section 78. Subsections (6) through (10) of section 429.23,
 3292  Florida Statutes, are renumbered as subsections (5) through (9),
 3293  respectively, and present subsection (5) of that section is
 3294  amended to read:
 3295         429.23 Internal risk management and quality assurance
 3296  program; adverse incidents and reporting requirements.—
 3297         (5) Each facility shall report monthly to the agency any
 3298  liability claim filed against it. The report must include the
 3299  name of the resident, the dates of the incident leading to the
 3300  claim, if applicable, and the type of injury or violation of
 3301  rights alleged to have occurred. This report is not discoverable
 3302  in any civil or administrative action, except in such actions
 3303  brought by the agency to enforce the provisions of this part.
 3304         Section 79. Paragraph (a) of subsection (1) and subsection
 3305  (2) of section 429.255, Florida Statutes, are amended to read:
 3306         429.255 Use of personnel; emergency care.—
 3307         (1)(a) Persons under contract to the facility or, facility
 3308  staff, or volunteers, who are licensed according to part I of
 3309  chapter 464, or those persons exempt under s. 464.022(1), and
 3310  others as defined by rule, may administer medications to
 3311  residents, take residents’ vital signs, manage individual weekly
 3312  pill organizers for residents who self-administer medication,
 3313  give prepackaged enemas ordered by a physician, observe
 3314  residents, document observations on the appropriate resident’s
 3315  record, report observations to the resident’s physician, and
 3316  contract or allow residents or a resident’s representative,
 3317  designee, surrogate, guardian, or attorney in fact to contract
 3318  with a third party, provided residents meet the criteria for
 3319  appropriate placement as defined in s. 429.26. Persons under
 3320  contract to the facility or facility staff who are licensed
 3321  according to part I of chapter 464 may provide limited nursing
 3322  services. Nursing assistants certified pursuant to part II of
 3323  chapter 464 may take residents’ vital signs as directed by a
 3324  licensed nurse or physician. The facility is responsible for
 3325  maintaining documentation of services provided under this
 3326  paragraph and as required by rule and ensuring that staff are
 3327  adequately trained to monitor residents receiving these
 3328  services.
 3329         (2) In facilities licensed to provide extended congregate
 3330  care, persons under contract to the facility or, facility staff,
 3331  or volunteers, who are licensed according to part I of chapter
 3332  464, or those persons exempt under s. 464.022(1), or those
 3333  persons certified as nursing assistants pursuant to part II of
 3334  chapter 464, may also perform all duties within the scope of
 3335  their license or certification, as approved by the facility
 3336  administrator and pursuant to this part.
 3337         Section 80. Subsections (4), (5), (6), and (7) of section
 3338  429.28, Florida Statutes, are renumbered as subsections (3),
 3339  (4), (5), and (6), respectively, and present subsections (3) and
 3340  (6) of that section are amended to read:
 3341         429.28 Resident bill of rights.—
 3342         (3)(a) The agency shall conduct a survey to determine
 3343  general compliance with facility standards and compliance with
 3344  residents’ rights as a prerequisite to initial licensure or
 3345  licensure renewal.
 3346         (b) In order to determine whether the facility is
 3347  adequately protecting residents’ rights, the biennial survey
 3348  shall include private informal conversations with a sample of
 3349  residents and consultation with the ombudsman council in the
 3350  planning and service area in which the facility is located to
 3351  discuss residents’ experiences within the facility.
 3352         (c) During any calendar year in which no survey is
 3353  conducted, the agency shall conduct at least one monitoring
 3354  visit of each facility cited in the previous year for a class I
 3355  or class II violation, or more than three uncorrected class III
 3356  violations.
 3357         (d) The agency may conduct periodic followup inspections as
 3358  necessary to monitor the compliance of facilities with a history
 3359  of any class I, class II, or class III violations that threaten
 3360  the health, safety, or security of residents.
 3361         (e) The agency may conduct complaint investigations as
 3362  warranted to investigate any allegations of noncompliance with
 3363  requirements required under this part or rules adopted under
 3364  this part.
 3365         (5)(6) Any facility which terminates the residency of an
 3366  individual who participated in activities specified in
 3367  subsection (4) (5) shall show good cause in a court of competent
 3368  jurisdiction.
 3369         Section 81. Subsection (1) of section 429.294, Florida
 3370  Statutes, is amended to read:
 3371         429.294 Availability of facility records for investigation
 3372  of resident’s rights violations and defenses; penalty.—
 3373         (1) Failure to provide complete copies of a resident’s
 3374  records, including, but not limited to, all medical records and
 3375  the resident’s chart, within the control or possession of the
 3376  facility within 10 days, constitutes in accordance with the
 3377  provisions of s. 400.145, shall constitute evidence of failure
 3378  of that party to comply with good faith discovery requirements
 3379  and waives shall waive the good faith certificate and presuit
 3380  notice requirements under this part by the requesting party.
 3381         Section 82. Paragraphs (i) and (j) of subsection (1) and
 3382  subsection (3) of section 429.41, Florida Statutes, are amended,
 3383  and present subsections (4) and (5) of that section are
 3384  renumbered subsections (3) and (4), respectively, to read:
 3385         429.41 Rules establishing standards.—
 3386         (1) It is the intent of the Legislature that rules
 3387  published and enforced pursuant to this section shall include
 3388  criteria by which a reasonable and consistent quality of
 3389  resident care and quality of life may be ensured and the results
 3390  of such resident care may be demonstrated. Such rules shall also
 3391  ensure a safe and sanitary environment that is residential and
 3392  noninstitutional in design or nature. It is further intended
 3393  that reasonable efforts be made to accommodate the needs and
 3394  preferences of residents to enhance the quality of life in a
 3395  facility. The agency, in consultation with the department, may
 3396  adopt rules to administer the requirements of part II of chapter
 3397  408. In order to provide safe and sanitary facilities and the
 3398  highest quality of resident care accommodating the needs and
 3399  preferences of residents, the department, in consultation with
 3400  the agency, the Department of Children and Family Services, and
 3401  the Department of Health, shall adopt rules, policies, and
 3402  procedures to administer this part, which must include
 3403  reasonable and fair minimum standards in relation to:
 3404         (i) Facilities holding an a limited nursing, extended
 3405  congregate care, or limited mental health license.
 3406         (j) The establishment of specific criteria to define
 3407  appropriateness of resident admission and continued residency in
 3408  a facility holding a standard, limited nursing, extended
 3409  congregate care, and limited mental health license.
 3410         (3) The department shall submit a copy of proposed rules to
 3411  the Speaker of the House of Representatives, the President of
 3412  the Senate, and appropriate committees of substance for review
 3413  and comment prior to the promulgation thereof. Rules promulgated
 3414  by the department shall encourage the development of homelike
 3415  facilities which promote the dignity, individuality, personal
 3416  strengths, and decisionmaking ability of residents.
 3417         Section 83. Subsections (1) and (2) of section 429.53,
 3418  Florida Statutes, are amended to read:
 3419         429.53 Consultation by the agency.—
 3420         (1) The area offices of licensure and certification of the
 3421  agency shall provide consultation to the following upon request:
 3422         (a) A licensee of a facility.
 3423         (b) A person interested in obtaining a license to operate a
 3424  facility under this part.
 3425         (2) As used in this section, “consultation” includes:
 3426         (a) An explanation of the requirements of this part and
 3427  rules adopted pursuant thereto;
 3428         (b) An explanation of the license application and renewal
 3429  procedures; and
 3430         (c) The provision of a checklist of general local and state
 3431  approvals required prior to constructing or developing a
 3432  facility and a listing of the types of agencies responsible for
 3433  such approvals;
 3434         (d) An explanation of benefits and financial assistance
 3435  available to a recipient of supplemental security income
 3436  residing in a facility;
 3437         (c)(e) Any other information which the agency deems
 3438  necessary to promote compliance with the requirements of this
 3439  part; and
 3440         (f) A preconstruction review of a facility to ensure
 3441  compliance with agency rules and this part.
 3442         Section 84. Subsections (1) and (2) of section 429.54,
 3443  Florida Statutes, are renumbered as subsections (2) and (3),
 3444  respectively, and a new subsection (1) is added to that section
 3445  to read:
 3446         429.54 Collection of information; local subsidy.—
 3447         (1) A facility that is licensed under this part must report
 3448  electronically to the agency semiannually data related to the
 3449  facility, including, but not limited to, the total number of
 3450  residents, the number of residents who are receiving limited
 3451  mental health services, the number of residents who are
 3452  receiving extended congregate care services, the number of
 3453  residents who are receiving limited nursing services, and
 3454  professional staffing employed by or under contract with the
 3455  licensee to provide resident services. The department, in
 3456  consultation with the agency, shall adopt rules to administer
 3457  this subsection.
 3458         Section 85. Subsections (1) and (5) of section 429.71,
 3459  Florida Statutes, are amended to read:
 3460         429.71 Classification of violations deficiencies;
 3461  administrative fines.—
 3462         (1) In addition to the requirements of part II of chapter
 3463  408 and in addition to any other liability or penalty provided
 3464  by law, the agency may impose an administrative fine on a
 3465  provider according to the following classification:
 3466         (a) Class I violations are defined in s. 408.813 those
 3467  conditions or practices related to the operation and maintenance
 3468  of an adult family-care home or to the care of residents which
 3469  the agency determines present an imminent danger to the
 3470  residents or guests of the facility or a substantial probability
 3471  that death or serious physical or emotional harm would result
 3472  therefrom. The condition or practice that constitutes a class I
 3473  violation must be abated or eliminated within 24 hours, unless a
 3474  fixed period, as determined by the agency, is required for
 3475  correction. A class I violation deficiency is subject to an
 3476  administrative fine in an amount not less than $500 and not
 3477  exceeding $1,000 for each violation. A fine may be levied
 3478  notwithstanding the correction of the deficiency.
 3479         (b) Class II violations are defined in s. 408.813 those
 3480  conditions or practices related to the operation and maintenance
 3481  of an adult family-care home or to the care of residents which
 3482  the agency determines directly threaten the physical or
 3483  emotional health, safety, or security of the residents, other
 3484  than class I violations. A class II violation is subject to an
 3485  administrative fine in an amount not less than $250 and not
 3486  exceeding $500 for each violation. A citation for a class II
 3487  violation must specify the time within which the violation is
 3488  required to be corrected. If a class II violation is corrected
 3489  within the time specified, no civil penalty shall be imposed,
 3490  unless it is a repeated offense.
 3491         (c) Class III violations are defined in s. 408.813 those
 3492  conditions or practices related to the operation and maintenance
 3493  of an adult family-care home or to the care of residents which
 3494  the agency determines indirectly or potentially threaten the
 3495  physical or emotional health, safety, or security of residents,
 3496  other than class I or class II violations. A class III violation
 3497  is subject to an administrative fine in an amount not less than
 3498  $100 and not exceeding $250 for each violation. A citation for a
 3499  class III violation shall specify the time within which the
 3500  violation is required to be corrected. If a class III violation
 3501  is corrected within the time specified, no civil penalty shall
 3502  be imposed, unless it is a repeated violation offense.
 3503         (d) Class IV violations are defined in s. 408.813 those
 3504  conditions or occurrences related to the operation and
 3505  maintenance of an adult family-care home, or related to the
 3506  required reports, forms, or documents, which do not have the
 3507  potential of negatively affecting the residents. A provider that
 3508  does not correct A class IV violation within the time limit
 3509  specified by the agency is subject to an administrative fine in
 3510  an amount not less than $50 and not exceeding $100 for each
 3511  violation. Any class IV violation that is corrected during the
 3512  time the agency survey is conducted will be identified as an
 3513  agency finding and not as a violation, unless it is a repeat
 3514  violation.
 3515         (5) As an alternative to or in conjunction with an
 3516  administrative action against a provider, the agency may request
 3517  a plan of corrective action that demonstrates a good faith
 3518  effort to remedy each violation by a specific date, subject to
 3519  the approval of the agency.
 3520         Section 86. Section 429.915, Florida Statutes, is amended
 3521  to read:
 3522         429.915 Conditional license.—In addition to the license
 3523  categories available in part II of chapter 408, the agency may
 3524  issue a conditional license to an applicant for license renewal
 3525  or change of ownership if the applicant fails to meet all
 3526  standards and requirements for licensure. A conditional license
 3527  issued under this subsection must be limited to a specific
 3528  period not exceeding 6 months, as determined by the agency, and
 3529  must be accompanied by an approved plan of correction.
 3530         Section 87. Paragraphs (b) and (g) of subsection (3) of
 3531  section 430.80, Florida Statutes, are amended to read:
 3532         430.80 Implementation of a teaching nursing home pilot
 3533  project.—
 3534         (3) To be designated as a teaching nursing home, a nursing
 3535  home licensee must, at a minimum:
 3536         (b) Participate in a nationally recognized accreditation
 3537  program and hold a valid accreditation, such as the
 3538  accreditation awarded by the Joint Commission on Accreditation
 3539  of Healthcare Organizations, or, at the time of initial
 3540  designation, possess a Gold Seal Award as conferred by the state
 3541  on its licensed nursing home;
 3542         (g) Maintain insurance coverage pursuant to s.
 3543  400.141(1)(q)(s) or proof of financial responsibility in a
 3544  minimum amount of $750,000. Such proof of financial
 3545  responsibility may include:
 3546         1. Maintaining an escrow account consisting of cash or
 3547  assets eligible for deposit in accordance with s. 625.52; or
 3548         2. Obtaining and maintaining pursuant to chapter 675 an
 3549  unexpired, irrevocable, nontransferable and nonassignable letter
 3550  of credit issued by any bank or savings association organized
 3551  and existing under the laws of this state or any bank or savings
 3552  association organized under the laws of the United States that
 3553  has its principal place of business in this state or has a
 3554  branch office which is authorized to receive deposits in this
 3555  state. The letter of credit shall be used to satisfy the
 3556  obligation of the facility to the claimant upon presentment of a
 3557  final judgment indicating liability and awarding damages to be
 3558  paid by the facility or upon presentment of a settlement
 3559  agreement signed by all parties to the agreement when such final
 3560  judgment or settlement is a result of a liability claim against
 3561  the facility.
 3562         Section 88. Paragraph (d) of subsection (9) of section
 3563  440.102, Florida Statutes, is repealed.
 3564         Section 89. Paragraph (a) of subsection (2) of section
 3565  440.13, Florida Statutes, is amended to read:
 3566         440.13 Medical services and supplies; penalty for
 3567  violations; limitations.—
 3568         (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.—
 3569         (a) Subject to the limitations specified elsewhere in this
 3570  chapter, the employer shall furnish to the employee such
 3571  medically necessary remedial treatment, care, and attendance for
 3572  such period as the nature of the injury or the process of
 3573  recovery may require, which is in accordance with established
 3574  practice parameters and protocols of treatment as provided for
 3575  in this chapter, including medicines, medical supplies, durable
 3576  medical equipment, orthoses, prostheses, and other medically
 3577  necessary apparatus. Remedial treatment, care, and attendance,
 3578  including work-hardening programs or pain-management programs
 3579  accredited by the Commission on Accreditation of Rehabilitation
 3580  Facilities or the Joint Commission on the Accreditation of
 3581  Health Organizations or pain-management programs affiliated with
 3582  medical schools, shall be considered as covered treatment only
 3583  when such care is given based on a referral by a physician as
 3584  defined in this chapter. Medically necessary treatment, care,
 3585  and attendance does not include chiropractic services in excess
 3586  of 24 treatments or rendered 12 weeks beyond the date of the
 3587  initial chiropractic treatment, whichever comes first, unless
 3588  the carrier authorizes additional treatment or the employee is
 3589  catastrophically injured.
 3590  
 3591  Failure of the carrier to timely comply with this subsection
 3592  shall be a violation of this chapter and the carrier shall be
 3593  subject to penalties as provided for in s. 440.525.
 3594         Section 90. Subsection (1) of section 483.035, Florida
 3595  Statutes, is amended to read:
 3596         483.035 Clinical laboratories operated by practitioners for
 3597  exclusive use; licensure and regulation.—
 3598         (1) A clinical laboratory operated by one or more
 3599  practitioners licensed under chapter 458, chapter 459, chapter
 3600  460, chapter 461, chapter 462, part I of chapter 464, or chapter
 3601  466, exclusively in connection with the diagnosis and treatment
 3602  of their own patients, must be licensed under this part and must
 3603  comply with the provisions of this part, except that the agency
 3604  shall adopt rules for staffing, for personnel, including
 3605  education and training of personnel, for proficiency testing,
 3606  and for construction standards relating to the licensure and
 3607  operation of the laboratory based upon and not exceeding the
 3608  same standards contained in the federal Clinical Laboratory
 3609  Improvement Amendments of 1988 and the federal regulations
 3610  adopted thereunder.
 3611         Section 91. Subsections (1) and (9) of section 483.051,
 3612  Florida Statutes, are amended to read:
 3613         483.051 Powers and duties of the agency.—The agency shall
 3614  adopt rules to implement this part, which rules must include,
 3615  but are not limited to, the following:
 3616         (1) LICENSING; QUALIFICATIONS.—The agency shall provide for
 3617  biennial licensure of all nonwaived clinical laboratories
 3618  meeting the requirements of this part and shall prescribe the
 3619  qualifications necessary for such licensure, including, but not
 3620  limited to, an application for or proof of a certificate under
 3621  Clinical Laboratory Improvement Amendments of 1988. A nonwaived
 3622  laboratory is a laboratory that has not been granted a
 3623  certificate of waiver by the Centers for Medicare and Medicaid
 3624  Services under the Clinical Laboratory Improvement Amendments of
 3625  1988 and the federal rules adopted thereunder.
 3626         (9) ALTERNATE-SITE TESTING.—The agency, in consultation
 3627  with the Board of Clinical Laboratory Personnel, shall adopt, by
 3628  rule, the criteria for alternate-site testing to be performed
 3629  under the supervision of a clinical laboratory director. The
 3630  elements to be addressed in the rule include, but are not
 3631  limited to: a hospital internal needs assessment; a protocol of
 3632  implementation including tests to be performed and who will
 3633  perform the tests; criteria to be used in selecting the method
 3634  of testing to be used for alternate-site testing; minimum
 3635  training and education requirements for those who will perform
 3636  alternate-site testing, such as documented training, licensure,
 3637  certification, or other medical professional background not
 3638  limited to laboratory professionals; documented inservice
 3639  training as well as initial and ongoing competency validation;
 3640  an appropriate internal and external quality control protocol;
 3641  an internal mechanism for identifying and tracking alternate
 3642  site testing by the central laboratory; and recordkeeping
 3643  requirements. Alternate-site testing locations must register
 3644  when the clinical laboratory applies to renew its license. For
 3645  purposes of this subsection, the term “alternate-site testing”
 3646  means any laboratory testing done under the administrative
 3647  control of a hospital, but performed out of the physical or
 3648  administrative confines of the central laboratory.
 3649         Section 92. Section 483.294, Florida Statutes, is amended
 3650  to read:
 3651         483.294 Inspection of centers.—In accordance with s.
 3652  408.811, the agency shall biennially, at least once annually,
 3653  inspect the premises and operations of all centers subject to
 3654  licensure under this part.
 3655         Section 93. Subsection (4) is added to section 626.9541,
 3656  Florida Statutes, to read:
 3657         626.9541 Unfair methods of competition and unfair or
 3658  deceptive acts or practices defined; alternative rates of
 3659  payment; wellness programs.—
 3660         (4) WELLNESS PROGRAMS.—An insurer issuing a group or
 3661  individual health benefit plan may offer a voluntary wellness or
 3662  health-improvement program that allows for rewards or
 3663  incentives, including, but not limited to, merchandise, gift
 3664  cards, debit cards, premium discounts or rebates, contributions
 3665  towards a member’s health savings account, modifications to
 3666  copayment, deductible, or coinsurance amounts, or any
 3667  combination of these incentives, to encourage or reward
 3668  participation in the program. The health plan member may be
 3669  required to provide verification, such as a statement from his
 3670  or her physician, that a medical condition makes it unreasonably
 3671  difficult or medically inadvisable for the individual to
 3672  participate in the wellness program. Any reward or incentive
 3673  established under this subsection is not an insurance benefit
 3674  and does not violate this section. This subsection does not
 3675  prohibit an insurer from offering incentives or rewards to
 3676  members for adherence to wellness or health improvement programs
 3677  if otherwise allowed by state or federal law. Notwithstanding
 3678  any provision of this subsection, no insurer, nor its agent, may
 3679  use any incentive authorized by this subsection for the purpose
 3680  of redirecting patients from one health care insurance plan to
 3681  another.
 3682         Section 94. Subsection (1) of section 627.645, Florida
 3683  Statutes, is amended to read:
 3684         627.645 Denial of health insurance claims restricted.—
 3685         (1) No claim for payment under a health insurance policy or
 3686  self-insured program of health benefits for treatment, care, or
 3687  services in a licensed hospital which is accredited by the Joint
 3688  Commission on the Accreditation of Hospitals, the American
 3689  Osteopathic Association, or the Commission on the Accreditation
 3690  of Rehabilitative Facilities shall be denied because such
 3691  hospital lacks major surgical facilities and is primarily of a
 3692  rehabilitative nature, if such rehabilitation is specifically
 3693  for treatment of physical disability.
 3694         Section 95. Paragraph (c) of subsection (2) of section
 3695  627.668, Florida Statutes, is amended to read:
 3696         627.668 Optional coverage for mental and nervous disorders
 3697  required; exception.—
 3698         (2) Under group policies or contracts, inpatient hospital
 3699  benefits, partial hospitalization benefits, and outpatient
 3700  benefits consisting of durational limits, dollar amounts,
 3701  deductibles, and coinsurance factors shall not be less favorable
 3702  than for physical illness generally, except that:
 3703         (c) Partial hospitalization benefits shall be provided
 3704  under the direction of a licensed physician. For purposes of
 3705  this part, the term “partial hospitalization services” is
 3706  defined as those services offered by a program accredited by the
 3707  Joint Commission on Accreditation of Hospitals (JCAH) or in
 3708  compliance with equivalent standards. Alcohol rehabilitation
 3709  programs accredited by the Joint Commission on Accreditation of
 3710  Hospitals or approved by the state and licensed drug abuse
 3711  rehabilitation programs shall also be qualified providers under
 3712  this section. In any benefit year, if partial hospitalization
 3713  services or a combination of inpatient and partial
 3714  hospitalization are utilized, the total benefits paid for all
 3715  such services shall not exceed the cost of 30 days of inpatient
 3716  hospitalization for psychiatric services, including physician
 3717  fees, which prevail in the community in which the partial
 3718  hospitalization services are rendered. If partial
 3719  hospitalization services benefits are provided beyond the limits
 3720  set forth in this paragraph, the durational limits, dollar
 3721  amounts, and coinsurance factors thereof need not be the same as
 3722  those applicable to physical illness generally.
 3723         Section 96. Subsection (3) of section 627.669, Florida
 3724  Statutes, is amended to read:
 3725         627.669 Optional coverage required for substance abuse
 3726  impaired persons; exception.—
 3727         (3) The benefits provided under this section shall be
 3728  applicable only if treatment is provided by, or under the
 3729  supervision of, or is prescribed by, a licensed physician or
 3730  licensed psychologist and if services are provided in a program
 3731  accredited by the Joint Commission on Accreditation of Hospitals
 3732  or approved by the state.
 3733         Section 97. Paragraph (a) of subsection (1) of section
 3734  627.736, Florida Statutes, is amended to read:
 3735         627.736 Required personal injury protection benefits;
 3736  exclusions; priority; claims.—
 3737         (1) REQUIRED BENEFITS.—Every insurance policy complying
 3738  with the security requirements of s. 627.733 shall provide
 3739  personal injury protection to the named insured, relatives
 3740  residing in the same household, persons operating the insured
 3741  motor vehicle, passengers in such motor vehicle, and other
 3742  persons struck by such motor vehicle and suffering bodily injury
 3743  while not an occupant of a self-propelled vehicle, subject to
 3744  the provisions of subsection (2) and paragraph (4)(e), to a
 3745  limit of $10,000 for loss sustained by any such person as a
 3746  result of bodily injury, sickness, disease, or death arising out
 3747  of the ownership, maintenance, or use of a motor vehicle as
 3748  follows:
 3749         (a) Medical benefits.—Eighty percent of all reasonable
 3750  expenses for medically necessary medical, surgical, X-ray,
 3751  dental, and rehabilitative services, including prosthetic
 3752  devices, and medically necessary ambulance, hospital, and
 3753  nursing services. However, the medical benefits shall provide
 3754  reimbursement only for such services and care that are lawfully
 3755  provided, supervised, ordered, or prescribed by a physician
 3756  licensed under chapter 458 or chapter 459, a dentist licensed
 3757  under chapter 466, or a chiropractic physician licensed under
 3758  chapter 460 or that are provided by any of the following persons
 3759  or entities:
 3760         1. A hospital or ambulatory surgical center licensed under
 3761  chapter 395.
 3762         2. A person or entity licensed under ss. 401.2101-401.45
 3763  that provides emergency transportation and treatment.
 3764         3. An entity wholly owned by one or more physicians
 3765  licensed under chapter 458 or chapter 459, chiropractic
 3766  physicians licensed under chapter 460, or dentists licensed
 3767  under chapter 466 or by such practitioner or practitioners and
 3768  the spouse, parent, child, or sibling of that practitioner or
 3769  those practitioners.
 3770         4. An entity wholly owned, directly or indirectly, by a
 3771  hospital or hospitals.
 3772         5. A health care clinic licensed under ss. 400.990-400.995
 3773  that is:
 3774         a. Accredited by the Joint Commission on Accreditation of
 3775  Healthcare Organizations, the American Osteopathic Association,
 3776  the Commission on Accreditation of Rehabilitation Facilities, or
 3777  the Accreditation Association for Ambulatory Health Care, Inc.;
 3778  or
 3779         b. A health care clinic that:
 3780         (I) Has a medical director licensed under chapter 458,
 3781  chapter 459, or chapter 460;
 3782         (II) Has been continuously licensed for more than 3 years
 3783  or is a publicly traded corporation that issues securities
 3784  traded on an exchange registered with the United States
 3785  Securities and Exchange Commission as a national securities
 3786  exchange; and
 3787         (III) Provides at least four of the following medical
 3788  specialties:
 3789         (A) General medicine.
 3790         (B) Radiography.
 3791         (C) Orthopedic medicine.
 3792         (D) Physical medicine.
 3793         (E) Physical therapy.
 3794         (F) Physical rehabilitation.
 3795         (G) Prescribing or dispensing outpatient prescription
 3796  medication.
 3797         (H) Laboratory services.
 3798  
 3799  The Financial Services Commission shall adopt by rule the form
 3800  that must be used by an insurer and a health care provider
 3801  specified in subparagraph 3., subparagraph 4., or subparagraph
 3802  5. to document that the health care provider meets the criteria
 3803  of this paragraph, which rule must include a requirement for a
 3804  sworn statement or affidavit.
 3805  
 3806  Only insurers writing motor vehicle liability insurance in this
 3807  state may provide the required benefits of this section, and no
 3808  such insurer shall require the purchase of any other motor
 3809  vehicle coverage other than the purchase of property damage
 3810  liability coverage as required by s. 627.7275 as a condition for
 3811  providing such required benefits. Insurers may not require that
 3812  property damage liability insurance in an amount greater than
 3813  $10,000 be purchased in conjunction with personal injury
 3814  protection. Such insurers shall make benefits and required
 3815  property damage liability insurance coverage available through
 3816  normal marketing channels. Any insurer writing motor vehicle
 3817  liability insurance in this state who fails to comply with such
 3818  availability requirement as a general business practice shall be
 3819  deemed to have violated part IX of chapter 626, and such
 3820  violation shall constitute an unfair method of competition or an
 3821  unfair or deceptive act or practice involving the business of
 3822  insurance; and any such insurer committing such violation shall
 3823  be subject to the penalties afforded in such part, as well as
 3824  those which may be afforded elsewhere in the insurance code.
 3825         Section 98. Subsection (12) of section 641.495, Florida
 3826  Statutes, is amended to read:
 3827         641.495 Requirements for issuance and maintenance of
 3828  certificate.—
 3829         (12) The provisions of part I of chapter 395 do not apply
 3830  to a health maintenance organization that, on or before January
 3831  1, 1991, provides not more than 10 outpatient holding beds for
 3832  short-term and hospice-type patients in an ambulatory care
 3833  facility for its members, provided that such health maintenance
 3834  organization maintains current accreditation by the Joint
 3835  Commission on Accreditation of Health Care Organizations, the
 3836  Accreditation Association for Ambulatory Health Care, or the
 3837  National Committee for Quality Assurance.
 3838         Section 99. Subsection (13) of section 651.118, Florida
 3839  Statutes, is amended to read:
 3840         651.118 Agency for Health Care Administration; certificates
 3841  of need; sheltered beds; community beds.—
 3842         (13) Residents, as defined in this chapter, are not
 3843  considered new admissions for the purpose of s.
 3844  400.141(1)(n)(o)1.d.
 3845         Section 100. Subsection (2) of section 766.1015, Florida
 3846  Statutes, is amended to read:
 3847         766.1015 Civil immunity for members of or consultants to
 3848  certain boards, committees, or other entities.—
 3849         (2) Such committee, board, group, commission, or other
 3850  entity must be established in accordance with state law or in
 3851  accordance with requirements of the Joint Commission on
 3852  Accreditation of Healthcare Organizations, established and duly
 3853  constituted by one or more public or licensed private hospitals
 3854  or behavioral health agencies, or established by a governmental
 3855  agency. To be protected by this section, the act, decision,
 3856  omission, or utterance may not be made or done in bad faith or
 3857  with malicious intent.
 3858         Section 101. Subsection (4) of section 766.202, Florida
 3859  Statutes, is amended to read:
 3860         766.202 Definitions; ss. 766.201-766.212.—As used in ss.
 3861  766.201-766.212, the term:
 3862         (4) “Health care provider” means any hospital, ambulatory
 3863  surgical center, or mobile surgical facility as defined and
 3864  licensed under chapter 395; a birth center licensed under
 3865  chapter 383; any person licensed under chapter 458, chapter 459,
 3866  chapter 460, chapter 461, chapter 462, chapter 463, part I of
 3867  chapter 464, chapter 466, chapter 467, part XIV of chapter 468,
 3868  or chapter 486; a clinical lab licensed under chapter 483; a
 3869  health maintenance organization certificated under part I of
 3870  chapter 641; a blood bank; a plasma center; an industrial
 3871  clinic; a renal dialysis facility; or a professional association
 3872  partnership, corporation, joint venture, or other association
 3873  for professional activity by health care providers.
 3874         Section 102. Paragraph (j) is added to subsection (3) of
 3875  section 817.505, Florida Statutes, to read:
 3876         817.505 Patient brokering prohibited; exceptions;
 3877  penalties.—
 3878         (3) This section shall not apply to:
 3879         (j) Any payment by an assisted living facility, as defined
 3880  in s. 429.02, which is permitted under s. 429.195(3).
 3881         Section 103. Section 381.06014, Florida Statutes, is
 3882  amended to read:
 3883         381.06014 Blood establishments.—
 3884         (1) As used in this section, the term:
 3885         (a) “Blood establishment” means any person, entity, or
 3886  organization, operating within the state, which examines an
 3887  individual for the purpose of blood donation or which collects,
 3888  processes, stores, tests, or distributes blood or blood
 3889  components collected from the human body for the purpose of
 3890  transfusion, for any other medical purpose, or for the
 3891  production of any biological product. A person, entity, or
 3892  organization that uses a mobile unit to conduct such activities
 3893  within the state is also a blood establishment.
 3894         (b) “Volunteer donor” means a person who does not receive
 3895  remuneration, other than an incentive, for a blood donation
 3896  intended for transfusion, and the product container of the
 3897  donation from the person qualifies for labeling with the
 3898  statement “volunteer donor” under 21 C.F.R. s. 606.121.
 3899         (2) Any blood establishment operating in the state may not
 3900  conduct any activity defined in paragraph (1)(a) subsection (1)
 3901  unless that blood establishment is operated in a manner
 3902  consistent with the provisions of Title 21 C.F.R. parts 211 and
 3903  600-640, Code of Federal Regulations.
 3904         (3) Any blood establishment determined to be operating in
 3905  the state in a manner not consistent with the provisions of
 3906  Title 21 C.F.R. parts 211 and 600-640, Code of Federal
 3907  Regulations, and in a manner that constitutes a danger to the
 3908  health or well-being of donors or recipients as evidenced by the
 3909  federal Food and Drug Administration’s inspection reports and
 3910  the revocation of the blood establishment’s license or
 3911  registration is shall be in violation of this chapter and must
 3912  shall immediately cease all operations in the state.
 3913         (4) The operation of a blood establishment in a manner not
 3914  consistent with the provisions of Title 21 C.F.R. parts 211 and
 3915  600-640, Code of Federal Regulations, and in a manner that
 3916  constitutes a danger to the health or well-being of blood donors
 3917  or recipients as evidenced by the federal Food and Drug
 3918  Administration’s inspection process is declared a nuisance and
 3919  inimical to the public health, welfare, and safety. The Agency
 3920  for Health Care Administration or any state attorney may bring
 3921  an action for an injunction to restrain such operations or
 3922  enjoin the future operation of the blood establishment.
 3923         (5) A local government may not restrict the access to or
 3924  use of any public facility or infrastructure for the collection
 3925  of blood or blood components from volunteer donors based on
 3926  whether the blood establishment is operating as a for-profit
 3927  organization or not-for-profit organization.
 3928         (6) In determining the service fee of blood or blood
 3929  components received from volunteer donors and sold to hospitals
 3930  or other health care providers, a blood establishment may not
 3931  base the service fee of the blood or blood component solely on
 3932  whether the purchasing entity is a for-profit organization or
 3933  not-for-profit organization.
 3934         (7) A blood establishment that collects blood or blood
 3935  components from volunteer donors must disclose on the Internet
 3936  the information required under this subsection to educate and
 3937  inform donors and the public about the blood establishment’s
 3938  activities. A hospital that collects blood or blood components
 3939  to be used only by that hospital’s licensed facilities or by a
 3940  health care provider that is a part of the hospital’s business
 3941  entity is exempt from the disclosure requirements in this
 3942  subsection. The information required to be disclosed under this
 3943  subsection may be cumulative for all blood establishments within
 3944  a business entity. A blood establishment must disclose on its
 3945  website all of the following information:
 3946         (a) A description of the steps involved in collecting,
 3947  processing, and distributing volunteer donations.
 3948         (b) By March 1 of each year, the number of units of blood
 3949  components which were:
 3950         1. Produced by the blood establishment during the preceding
 3951  calendar year;
 3952         2. Obtained from other sources during the preceding
 3953  calendar year;
 3954         3. Distributed during the preceding calendar year to health
 3955  care providers located outside this state. However, if the blood
 3956  establishment collects donations in a county outside this state,
 3957  distributions to health care providers in that county shall be
 3958  excluded. Such information shall be reported in the aggregate
 3959  for health care providers located within the United States and
 3960  its territories or outside the United States and its
 3961  territories; and
 3962         4. Distributed during the preceding calendar year to
 3963  entities that are not health care providers. Such information
 3964  shall be reported in the aggregate for purchasers located within
 3965  the United States and its territories or outside the United
 3966  States and its territories.
 3967         (c) The blood establishment’s conflict-of-interest policy,
 3968  policy concerning related-party transactions, whistleblower
 3969  policy, and policy for determining executive compensation. If a
 3970  change occurs to any of these documents, the revised document
 3971  must be available on the blood establishment’s website by the
 3972  following March 1.
 3973         (d) Except for a hospital that collects blood or blood
 3974  components from volunteer donors:
 3975         1. The most recent 3 years of the Return of Organization
 3976  Exempt from Income Tax, Internal Revenue Service Form 990, if
 3977  the business entity for the blood establishment is eligible to
 3978  file such return. The Form 990 must be available on the blood
 3979  establishment’s website within 60 calendar days after it is
 3980  filed with the Internal Revenue Service; or
 3981         2. If the business entity for the blood establishment is
 3982  not eligible to file the Form 990 return, a balance sheet,
 3983  income statement, and statement of changes in cash flow, along
 3984  with the expression of an opinion thereon by an independent
 3985  certified public accountant who audited or reviewed such
 3986  financial statements. Such documents must be available on the
 3987  blood establishment’s website within 120 days after the end of
 3988  the blood establishment’s fiscal year and must remain on the
 3989  blood establishment’s website for at least 36 months.
 3990         (8) A blood establishment is liable for a civil penalty for
 3991  failing to make the disclosures required under subsection (7).
 3992  The Department of Legal Affairs may assess the civil penalty
 3993  against the blood establishment for each day that it fails to
 3994  make such required disclosures, but the penalty may not exceed
 3995  $10,000 per year. If multiple blood establishments operated by a
 3996  single business entity fail to meet such disclosure
 3997  requirements, the civil penalty may be assessed against only one
 3998  of the business entity’s blood establishments. The Department of
 3999  Legal Affairs may terminate an action if the blood establishment
 4000  agrees to pay a stipulated civil penalty. A civil penalty so
 4001  collected accrues to the state and shall be deposited as
 4002  received into the General Revenue Fund unallocated. The
 4003  Department of Legal Affairs may terminate the action and waive
 4004  the civil penalty upon a showing of good cause by the blood
 4005  establishment as to why the required disclosures were not made.
 4006         Section 104. Subsection (23) of section 499.003, Florida
 4007  Statutes, is amended to read:
 4008         499.003 Definitions of terms used in this part.—As used in
 4009  this part, the term:
 4010         (23) “Health care entity” means a closed pharmacy or any
 4011  person, organization, or business entity that provides
 4012  diagnostic, medical, surgical, or dental treatment or care, or
 4013  chronic or rehabilitative care, but does not include any
 4014  wholesale distributor or retail pharmacy licensed under state
 4015  law to deal in prescription drugs. However, a blood
 4016  establishment is a health care entity that may engage in the
 4017  wholesale distribution of prescription drugs under s.
 4018  499.01(2)(g)1.c.
 4019         Section 105. Subsection (21) of section 499.005, Florida
 4020  Statutes, is amended to read:
 4021         499.005 Prohibited acts.—It is unlawful for a person to
 4022  perform or cause the performance of any of the following acts in
 4023  this state:
 4024         (21) The wholesale distribution of any prescription drug
 4025  that was:
 4026         (a) Purchased by a public or private hospital or other
 4027  health care entity; or
 4028         (b) Donated or supplied at a reduced price to a charitable
 4029  organization,
 4030  
 4031  unless the wholesale distribution of the prescription drug is
 4032  authorized in s. 499.01(2)(g)1.c.
 4033         Section 106. Paragraphs (a) and (g) of subsection (2) of
 4034  section 499.01, Florida Statutes, are amended to read:
 4035         499.01 Permits.—
 4036         (2) The following permits are established:
 4037         (a) Prescription drug manufacturer permit.—A prescription
 4038  drug manufacturer permit is required for any person that is a
 4039  manufacturer of a prescription drug and that manufactures or
 4040  distributes such prescription drugs in this state.
 4041         1. A person that operates an establishment permitted as a
 4042  prescription drug manufacturer may engage in wholesale
 4043  distribution of prescription drugs manufactured at that
 4044  establishment and must comply with all of the provisions of this
 4045  part, except s. 499.01212, and the rules adopted under this
 4046  part, except s. 499.01212, which that apply to a wholesale
 4047  distributor.
 4048         2. A prescription drug manufacturer must comply with all
 4049  appropriate state and federal good manufacturing practices.
 4050         3. A blood establishment, as defined in s. 381.06014,
 4051  operating in a manner consistent with the provisions of Title 21
 4052  C.F.R. parts 211 and 600-640, and manufacturing only the
 4053  prescription drugs described in s. 499.003(54)(d) is not
 4054  required to be permitted as a prescription drug manufacturer
 4055  under this paragraph or to register products under s. 499.015.
 4056         (g) Restricted prescription drug distributor permit.—
 4057         1. A restricted prescription drug distributor permit is
 4058  required for:
 4059         a. Any person located in this state that engages in the
 4060  distribution of a prescription drug, which distribution is not
 4061  considered “wholesale distribution” under s. 499.003(54)(a).
 4062         b.1.Any A person located in this state who engages in the
 4063  receipt or distribution of a prescription drug in this state for
 4064  the purpose of processing its return or its destruction must
 4065  obtain a permit as a restricted prescription drug distributor if
 4066  such person is not the person initiating the return, the
 4067  prescription drug wholesale supplier of the person initiating
 4068  the return, or the manufacturer of the drug.
 4069         c.A blood establishment located in this state which
 4070  collects blood and blood components only from volunteer donors
 4071  as defined in s. 381.06014 or pursuant to an authorized
 4072  practitioner’s order for medical treatment or therapy and
 4073  engages in the wholesale distribution of a prescription drug not
 4074  described in s. 499.003(54)(d) to a health care entity. The
 4075  health care entity receiving a prescription drug distributed
 4076  under this sub-subparagraph must be licensed as a closed
 4077  pharmacy or provide health care services at that establishment.
 4078  The blood establishment must operate in accordance with s.
 4079  381.06014 and may distribute only:
 4080         (I) Prescription drugs indicated for a bleeding or clotting
 4081  disorder or anemia;
 4082         (II) Blood-collection containers approved under s. 505 of
 4083  the federal act;
 4084         (III) Drugs that are blood derivatives, or a recombinant or
 4085  synthetic form of a blood derivative;
 4086         (IV) Prescription drugs that are identified in rules
 4087  adopted by the department and that are essential to services
 4088  performed or provided by blood establishments and authorized for
 4089  distribution by blood establishments under federal law; or
 4090         (V) To the extent authorized by federal law, drugs
 4091  necessary to collect blood or blood components from volunteer
 4092  blood donors; for blood establishment personnel to perform
 4093  therapeutic procedures under the direction and supervision of a
 4094  licensed physician; and to diagnose, treat, manage, and prevent
 4095  any reaction of either a volunteer blood donor or a patient
 4096  undergoing a therapeutic procedure performed under the direction
 4097  and supervision of a licensed physician,
 4098  
 4099  as long as all of the health care services provided by the blood
 4100  establishment are related to its activities as a registered
 4101  blood establishment or the health care services consist of
 4102  collecting, processing, storing, or administering human
 4103  hematopoietic stem cells or progenitor cells or performing
 4104  diagnostic testing of specimens if such specimens are tested
 4105  together with specimens undergoing routine donor testing.
 4106         2. Storage, handling, and recordkeeping of these
 4107  distributions by a person required to be permitted as a
 4108  restricted prescription drug distributor must comply with the
 4109  requirements for wholesale distributors under s. 499.0121, but
 4110  not those set forth in s. 499.01212 if the distribution occurs
 4111  pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
 4112         3. A person who applies for a permit as a restricted
 4113  prescription drug distributor, or for the renewal of such a
 4114  permit, must provide to the department the information required
 4115  under s. 499.012.
 4116         4. The department may adopt rules regarding the
 4117  distribution of prescription drugs by hospitals, health care
 4118  entities, charitable organizations, or other persons not
 4119  involved in wholesale distribution, and blood establishments,
 4120  which rules are necessary for the protection of the public
 4121  health, safety, and welfare.
 4122         Section 107. This act shall take effect July 1, 2011.