November 26, 2020
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       Florida Senate - 2010                      CS for CS for SB 2434
       
       
       
       By the Policy and Steering Committee on Ways and Means; the
       Committee on Health Regulation; and Senator Gardiner
       
       
       
       576-05334-10                                          20102434c2
    1                        A bill to be entitled                      
    2         An act relating to health care; amending s. 112.0455,
    3         F.S., relating to the Drug-Free Workplace Act;
    4         deleting an obsolete provision; amending s. 318.21,
    5         F.S.; revising distribution of funds from civil
    6         penalties imposed for traffic infractions by county
    7         courts; amending s. 381.00315, F.S.; directing the
    8         Department of Health to accept funds from counties,
    9         municipalities, and certain other entities for the
   10         purchase of certain products made available under a
   11         contract of the United States Department of Health and
   12         Human Services for the manufacture and delivery of
   13         such products in response to a public health
   14         emergency; amending s. 381.0072, F.S.; limiting
   15         Department of Health food service inspections in
   16         nursing homes; requiring the department to coordinate
   17         inspections with the Agency for Health Care
   18         Administration; amending s. 381.06014, F.S.; defining
   19         the term “volunteer donor”; requiring that certain
   20         blood establishments disclose specified information on
   21         the Internet; repealing s. 383.325, F.S., relating to
   22         confidentiality of inspection reports of licensed
   23         birth center facilities; amending s. 395.002, F.S.;
   24         revising and deleting definitions applicable to
   25         regulation of hospitals and other licensed facilities;
   26         conforming a cross-reference; amending s. 395.003,
   27         F.S.; deleting an obsolete provision; conforming a
   28         cross-reference; amending s. 395.0193, F.S.; requiring
   29         a licensed facility to report certain peer review
   30         information and final disciplinary actions to the
   31         Division of Medical Quality Assurance of the
   32         Department of Health rather than the Division of
   33         Health Quality Assurance of the Agency for Health Care
   34         Administration; amending s. 395.1023, F.S.; providing
   35         for the Department of Children and Family Services
   36         rather than the Department of Health to perform
   37         certain functions with respect to child protection
   38         cases; requiring certain hospitals to notify the
   39         Department of Children and Family Services of
   40         compliance; amending s. 395.1041, F.S., relating to
   41         hospital emergency services and care; deleting
   42         obsolete provisions; repealing s. 395.1046, F.S.,
   43         relating to complaint investigation procedures;
   44         amending s. 395.1055, F.S.; requiring licensed
   45         facility beds to conform to standards specified by the
   46         Agency for Health Care Administration, the Florida
   47         Building Code, and the Florida Fire Prevention Code;
   48         amending s. 395.10972, F.S.; revising a reference to
   49         the Florida Society of Healthcare Risk Management to
   50         conform to the current designation; amending s.
   51         395.2050, F.S.; revising a reference to the federal
   52         Health Care Financing Administration to conform to the
   53         current designation; amending s. 395.3036, F.S.;
   54         correcting a reference; repealing s. 395.3037, F.S.,
   55         relating to redundant definitions; amending ss.
   56         154.11, 394.741, 395.3038, 400.925, 400.9935, 408.05,
   57         440.13, 627.645, 627.668, 627.669, 627.736, 641.495,
   58         and 766.1015, F.S.; revising references to the Joint
   59         Commission on Accreditation of Healthcare
   60         Organizations, the Commission on Accreditation of
   61         Rehabilitation Facilities, and the Council on
   62         Accreditation to conform to their current
   63         designations; amending s. 395.602, F.S.; revising the
   64         definition of the term “rural hospital” to delete an
   65         obsolete provision; amending s. 400.021, F.S.;
   66         revising the definition of the term “geriatric
   67         outpatient clinic”; amending s. 400.0255, F.S.;
   68         correcting an obsolete cross-reference to
   69         administrative rules; amending s. 400.063, F.S.;
   70         deleting an obsolete provision; amending ss. 400.071
   71         and 400.0712, F.S.; revising applicability of general
   72         licensure requirements under part II of ch. 408, F.S.,
   73         to applications for nursing home licensure; revising
   74         provisions governing inactive licenses; amending s.
   75         400.111, F.S.; providing for disclosure of controlling
   76         interest of a nursing home facility upon request by
   77         the Agency for Health Care Administration; amending s.
   78         400.1183, F.S.; revising grievance record maintenance
   79         and reporting requirements for nursing homes; amending
   80         s. 400.141, F.S.; providing criteria for the provision
   81         of respite services by nursing homes; requiring a
   82         written plan of care; requiring a contract for
   83         services; requiring resident release to caregivers to
   84         be designated in writing; providing an exemption to
   85         the application of discharge planning rules; providing
   86         for residents’ rights; providing for use of personal
   87         medications; providing terms of respite stay;
   88         providing for communication of patient information;
   89         requiring a physician order for care and proof of a
   90         physical examination; providing for services for
   91         respite patients and duties of facilities with respect
   92         to such patients; conforming a cross-reference;
   93         requiring facilities to maintain clinical records that
   94         meet specified standards; providing a fine relating to
   95         an admissions moratorium; deleting requirement for
   96         facilities to submit certain information related to
   97         management companies to the agency; deleting a
   98         requirement for facilities to notify the agency of
   99         certain bankruptcy filings to conform to changes made
  100         by the act; amending s. 400.142, F.S.; deleting
  101         language relating to agency adoption of rules;
  102         amending 400.147, F.S.; revising reporting
  103         requirements for licensed nursing home facilities
  104         relating to adverse incidents; repealing s. 400.148,
  105         F.S., relating to the Medicaid “Up-or-Out” Quality of
  106         Care Contract Management Program; amending s. 400.162,
  107         F.S., requiring nursing homes to provide a resident
  108         property statement annually and upon request; amending
  109         s. 400.179, F.S.; revising requirements for nursing
  110         home lease bond alternative fees; deleting an obsolete
  111         provision; amending s. 400.19, F.S.; revising
  112         inspection requirements; repealing s. 400.195, F.S.,
  113         relating to agency reporting requirements; amending s.
  114         400.23, F.S.; deleting an obsolete provision;
  115         correcting a reference; 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. 400.484, F.S.; revising the
  122         schedule of home health agency inspection violations;
  123         amending s. 400.606, F.S.; revising the content
  124         requirements of the plan accompanying an initial or
  125         change-of-ownership application for licensure of a
  126         hospice; revising requirements relating to
  127         certificates of need for certain hospice facilities;
  128         amending s. 400.607, F.S.; revising grounds for agency
  129         action against a hospice; amending s. 400.915, F.S.;
  130         correcting an obsolete cross-reference to
  131         administrative rules; amending s. 400.931, F.S.;
  132         deleting a requirement that an applicant for a home
  133         medical equipment provider license submit a surety
  134         bond to the agency; amending s. 400.932, F.S.;
  135         revising grounds for the imposition of administrative
  136         penalties for certain violations by an employee of a
  137         home medical equipment provider; amending s. 400.967,
  138         F.S.; revising the schedule of inspection violations
  139         for intermediate care facilities for the
  140         developmentally disabled; providing a penalty for
  141         certain violations; amending s. 400.9905, F.S.;
  142         providing that part X of ch, 400, F.S., the Health
  143         Care Clinic Act, does not apply to an entity owned by
  144         a corporation with a specified amount of annual sales
  145         of health care services under certain circumstances or
  146         to an entity owned or controlled by a publicly traded
  147         entity with a specified amount of annual revenues;
  148         amending s. 400.991, F.S.; conforming terminology;
  149         revising application requirements relating to
  150         documentation of financial ability to operate a mobile
  151         clinic; amending s. 408.034, F.S.; revising agency
  152         authority relating to licensing of intermediate care
  153         facilities for the developmentally disabled; amending
  154         s. 408.036, F.S.; deleting an exemption from certain
  155         certificate-of-need review requirements for a hospice
  156         or a hospice inpatient facility; amending s. 408.043,
  157         F.S.; revising requirements for certain freestanding
  158         inpatient hospice care facilities to obtain a
  159         certificate of need; amending s. 408.061, F.S.;
  160         revising health care facility data reporting
  161         requirements; amending s. 408.10, F.S.; removing
  162         agency authority to investigate certain consumer
  163         complaints; amending s. 408.802, F.S.; removing
  164         applicability of part II of ch. 408, F.S., relating to
  165         general licensure requirements, to private review
  166         agents; amending s. 408.804, F.S.; providing penalties
  167         for altering, defacing, or falsifying a license
  168         certificate issued by the agency or displaying such an
  169         altered, defaced, or falsified certificate; amending
  170         s. 408.806, F.S.; revising agency responsibilities for
  171         notification of licensees of impending expiration of a
  172         license; requiring payment of a late fee for a license
  173         application to be considered complete under certain
  174         circumstances; amending s. 408.810, F.S.; revising
  175         provisions relating to information required for
  176         licensure; requiring proof of submission of notice to
  177         a mortgagor or landlord regarding provision of
  178         services requiring licensure; requiring disclosure of
  179         information by a controlling interest of certain court
  180         actions relating to financial instability within a
  181         specified time period; amending s. 408.813, F.S.;
  182         authorizing the agency to impose fines for
  183         unclassified violations of part II of ch. 408, F.S.;
  184         amending s. 408.815, F.S.; authorizing the agency to
  185         extend a license expiration date under certain
  186         circumstances; amending s. 409.221, F.S.; deleting a
  187         reporting requirement relating to the consumer
  188         directed care program; amending s. 409.91196, F.S.;
  189         conforming a cross-reference; amending s. 409.912,
  190         F.S.; revising procedures for implementation of a
  191         Medicaid prescribed-drug spending-control program;
  192         amending s. 429.07, F.S.; deleting the requirement for
  193         an assisted living facility to obtain an additional
  194         license in order to provide limited nursing services;
  195         deleting the requirement for the agency to conduct
  196         quarterly monitoring visits of facilities that hold a
  197         license to provide extended congregate care services;
  198         deleting the requirement for the department to report
  199         annually on the status of and recommendations related
  200         to extended congregate care; deleting the requirement
  201         for the agency to conduct monitoring visits at least
  202         twice a year to facilities providing limited nursing
  203         services; increasing the licensure fees and the
  204         maximum fee required for the standard license;
  205         increasing the licensure fees for the extended
  206         congregate care license; eliminating the license fee
  207         for the limited nursing services license; transferring
  208         from another provision of law the requirement that a
  209         biennial survey of an assisted living facility include
  210         specific actions to determine whether the facility is
  211         adequately protecting residents’ rights; providing
  212         that an assisted living facility that has a class I or
  213         class II violation is subject to monitoring visits;
  214         requiring a registered nurse to participate in certain
  215         monitoring visits; amending s. 429.11, F.S.; revising
  216         licensure application requirements for assisted living
  217         facilities to eliminate provisional licenses; amending
  218         s. 429.12, F.S.; revising notification requirements
  219         for the sale or transfer of ownership of an assisted
  220         living facility; amending s. 429.14, F.S.; removing a
  221         ground for the imposition of an administrative
  222         penalty; clarifying provisions relating to a
  223         facility’s request for a hearing under certain
  224         circumstances; authorizing the agency to provide
  225         certain information relating to the licensure status
  226         of assisted living facilities electronically or
  227         through the agency’s Internet website; amending s.
  228         429.17, F.S.; deleting provisions relating to the
  229         limited nursing services license; revising agency
  230         responsibilities regarding the issuance of conditional
  231         licenses; amending s. 429.19, F.S.; clarifying that a
  232         monitoring fee may be assessed in addition to an
  233         administrative fine; amending s. 429.23, F.S.;
  234         deleting reporting requirements for assisted living
  235         facilities relating to liability claims; amending s.
  236         429.255, F.S.; eliminating provisions authorizing the
  237         use of volunteers to provide certain health-care
  238         related services in assisted living facilities;
  239         authorizing assisted living facilities to provide
  240         limited nursing services; requiring an assisted living
  241         facility to be responsible for certain recordkeeping
  242         and staff to be trained to monitor residents receiving
  243         certain health-care-related services; amending s.
  244         429.28, F.S.; deleting a requirement for a biennial
  245         survey of an assisted living facility, to conform to
  246         changes made by the act; amending s. 429.35, F.S.;
  247         authorizing the agency to provide certain information
  248         relating to the inspections of assisted living
  249         facilities electronically or through the agency’s
  250         Internet website; amending s. 429.41, F.S., relating
  251         to rulemaking; conforming provisions to changes made
  252         by the act; amending s. 429.53, F.S.; revising
  253         provisions relating to consultation by the agency;
  254         revising a definition; amending s. 429.54, F.S.;
  255         requiring licensed assisted living facilities to
  256         electronically report certain data semiannually to the
  257         agency in accordance with rules adopted by the
  258         department; amending s. 429.71, F.S.; revising
  259         schedule of inspection violations for adult family
  260         care homes; amending s. 429.911, F.S.; deleting a
  261         ground for agency action against an adult day care
  262         center; amending s. 429.915, F.S.; revising agency
  263         responsibilities regarding the issuance of conditional
  264         licenses; amending s. 483.201, F.S.; providing for
  265         disciplinary action against clinical laboratories
  266         failing to disclose specified information on the
  267         Internet; providing a maximum annual administrative
  268         fine that may be imposed annually against certain
  269         clinical laboratories for failure to comply with such
  270         disclosure requirement; amending s. 483.294, F.S.;
  271         revising frequency of agency inspections of
  272         multiphasic health testing centers; amending s.
  273         499.003, F.S.; revising the definition of the term
  274         “health care entity” to clarify that a blood
  275         establishment may be a health care entity and engage
  276         in certain activities; removing a requirement that
  277         certain prescription drug purchasers maintain a
  278         separate inventory of certain prescription drugs;
  279         amending s. 499.005, F.S.; clarifying provisions
  280         prohibiting the unauthorized wholesale distribution of
  281         a prescription drug that was purchased by a hospital
  282         or other health care entity, to conform to changes
  283         made by the act; amending s. 499.01, F.S.; exempting
  284         certain blood establishments from the requirements to
  285         be permitted as a prescription drug manufacturer and
  286         register products; requiring that certain blood
  287         establishments obtain a restricted prescription drug
  288         distributor permit under specified conditions;
  289         limiting the prescription drugs that a blood
  290         establishment may distribute with the restricted
  291         prescription drug distributor permit; authorizing the
  292         Department of Health to adopt rules; amending s.
  293         499.01212, F.S.; exempting prescription drugs
  294         contained in sealed medical convenience kits from the
  295         pedigree paper requirements under specified
  296         circumstances; amending s. 633.081, F.S.; limiting
  297         Fire Marshal inspections of nursing homes to once a
  298         year; providing for additional inspections based on
  299         complaints and violations identified in the course of
  300         orientation or training activities; amending s.
  301         766.202, F.S.; adding persons licensed under part XIV
  302         of ch. 468, F.S., to the definition of “health care
  303         provider”; amending ss. 394.4787, 400.0239, 408.07,
  304         430.80, and 651.118, F.S.; conforming terminology and
  305         cross-references; revising a reference; providing an
  306         effective date.
  307  
  308  Be It Enacted by the Legislature of the State of Florida:
  309  
  310         Section 1. Present paragraph (e) of subsection (10) and
  311  paragraph (e) of subsection (14) of section 112.0455, Florida
  312  Statutes, are amended, and paragraphs (f) through (k) of
  313  subsection (10) of that section are redesignated as paragraphs
  314  (e) through (j), respectively, to read:
  315         112.0455 Drug-Free Workplace Act.—
  316         (10) EMPLOYER PROTECTION.—
  317         (e)Nothing in this section shall be construed to operate
  318  retroactively, and nothing in this section shall abrogate the
  319  right of an employer under state law to conduct drug tests prior
  320  to January 1, 1990. A drug test conducted by an employer prior
  321  to January 1, 1990, is not subject to this section.
  322         (14) DISCIPLINE REMEDIES.—
  323         (e) Upon resolving an appeal filed pursuant to paragraph
  324  (c), and finding a violation of this section, the commission may
  325  order the following relief:
  326         1. Rescind the disciplinary action, expunge related records
  327  from the personnel file of the employee or job applicant and
  328  reinstate the employee.
  329         2. Order compliance with paragraph (10)(f)(g).
  330         3. Award back pay and benefits.
  331         4. Award the prevailing employee or job applicant the
  332  necessary costs of the appeal, reasonable attorney’s fees, and
  333  expert witness fees.
  334         Section 2. Paragraph (n) of subsection (1) of section
  335  154.11, Florida Statutes, is amended to read:
  336         154.11 Powers of board of trustees.—
  337         (1) The board of trustees of each public health trust shall
  338  be deemed to exercise a public and essential governmental
  339  function of both the state and the county and in furtherance
  340  thereof it shall, subject to limitation by the governing body of
  341  the county in which such board is located, have all of the
  342  powers necessary or convenient to carry out the operation and
  343  governance of designated health care facilities, including, but
  344  without limiting the generality of, the foregoing:
  345         (n) To appoint originally the staff of physicians to
  346  practice in any designated facility owned or operated by the
  347  board and to approve the bylaws and rules to be adopted by the
  348  medical staff of any designated facility owned and operated by
  349  the board, such governing regulations to be in accordance with
  350  the standards of The Joint Commission on the Accreditation of
  351  Hospitals which provide, among other things, for the method of
  352  appointing additional staff members and for the removal of staff
  353  members.
  354         Section 3. Subsection (15) of section 318.21, Florida
  355  Statutes, is amended to read:
  356         318.21 Disposition of civil penalties by county courts.—All
  357  civil penalties received by a county court pursuant to the
  358  provisions of this chapter shall be distributed and paid monthly
  359  as follows:
  360         (15) Of the additional fine assessed under s. 318.18(3)(e)
  361  for a violation of s. 316.1893, 50 percent of the moneys
  362  received from the fines shall be remitted to the Department of
  363  Revenue and deposited into the Brain and Spinal Cord Injury
  364  Trust Fund of Department of Health and shall be appropriated to
  365  the Department of Health Agency for Health Care Administration
  366  as general revenue to provide an enhanced Medicaid payment to
  367  nursing homes that serve Medicaid recipients with spinal cord
  368  injuries that are medically complex and who are technologically
  369  and respiratory dependent with brain and spinal cord injuries.
  370  The remaining 50 percent of the moneys received from the
  371  enhanced fine imposed under s. 318.18(3)(e) shall be remitted to
  372  the Department of Revenue and deposited into the Department of
  373  Health Administrative Trust Fund to provide financial support to
  374  certified trauma centers in the counties where enhanced penalty
  375  zones are established to ensure the availability and
  376  accessibility of trauma services. Funds deposited into the
  377  Administrative Trust Fund under this subsection shall be
  378  allocated as follows:
  379         (a) Fifty percent shall be allocated equally among all
  380  Level I, Level II, and pediatric trauma centers in recognition
  381  of readiness costs for maintaining trauma services.
  382         (b) Fifty percent shall be allocated among Level I, Level
  383  II, and pediatric trauma centers based on each center’s relative
  384  volume of trauma cases as reported in the Department of Health
  385  Trauma Registry.
  386         Section 4. Subsection (3) is added to section 381.00315,
  387  Florida Statutes, to read:
  388         381.00315 Public health advisories; public health
  389  emergencies.—The State Health Officer is responsible for
  390  declaring public health emergencies and issuing public health
  391  advisories.
  392         (3)To facilitate effective emergency management, when the
  393  United States Department of Health and Human Services contracts
  394  for the manufacture and delivery of licensable products in
  395  response to a public health emergency and the terms of those
  396  contracts are made available to the states, the department shall
  397  accept funds provided by counties, municipalities, and other
  398  entities designated in the state emergency management plan
  399  required under s. 252.35(2)(a) for the purpose of participation
  400  in such contracts. The department shall deposit the funds into
  401  the Grants and Donations Trust Fund and expend the funds on
  402  behalf of the donor county, municipality, or other entity for
  403  the purchase the licensable products made available under the
  404  contract.
  405         Section 5. Paragraph (e) is added to subsection (2) of
  406  section 381.0072, Florida Statutes, to read:
  407         381.0072 Food service protection.—It shall be the duty of
  408  the Department of Health to adopt and enforce sanitation rules
  409  consistent with law to ensure the protection of the public from
  410  food-borne illness. These rules shall provide the standards and
  411  requirements for the storage, preparation, serving, or display
  412  of food in food service establishments as defined in this
  413  section and which are not permitted or licensed under chapter
  414  500 or chapter 509.
  415         (2) DUTIES.—
  416         (e)The department shall inspect food service
  417  establishments in nursing homes licensed under part II of
  418  chapter 400 twice each year. The department may make additional
  419  inspections only in response to complaints. The department shall
  420  coordinate inspections with the Agency for Health Care
  421  Administration, such that the department’s inspection is at
  422  least 60 days after a recertification visit by the Agency for
  423  Health Care Administration.
  424         Section 6. Section 381.06014, Florida Statutes, is amended
  425  to read:
  426         381.06014 Blood establishments.—
  427         (1) As used in this section, the term:
  428         (a) “Blood establishment” means any person, entity, or
  429  organization, operating within the state, which examines an
  430  individual for the purpose of blood donation or which collects,
  431  processes, stores, tests, or distributes blood or blood
  432  components collected from the human body for the purpose of
  433  transfusion, for any other medical purpose, or for the
  434  production of any biological product.
  435         (b) “Volunteer donor” means a person who does not receive
  436  remuneration, other than an incentive, for a blood donation
  437  intended for transfusion, and the product container of the
  438  donation from the person qualifies for labeling with the
  439  statement “volunteer donor” under 21 C.F.R. 606.121.
  440         (2) Any blood establishment operating in the state may not
  441  conduct any activity defined in subsection (1) unless that blood
  442  establishment is operated in a manner consistent with the
  443  provisions of Title 21 parts 211 and 600-640, Code of Federal
  444  Regulations.
  445         (3) Any blood establishment determined to be operating in
  446  the state in a manner not consistent with the provisions of
  447  Title 21 parts 211 and 600-640, Code of Federal Regulations, and
  448  in a manner that constitutes a danger to the health or well
  449  being of donors or recipients as evidenced by the federal Food
  450  and Drug Administration’s inspection reports and the revocation
  451  of the blood establishment’s license or registration shall be in
  452  violation of this chapter and shall immediately cease all
  453  operations in the state.
  454         (4) The operation of a blood establishment in a manner not
  455  consistent with the provisions of Title 21 parts 211 and 600
  456  640, Code of Federal Regulations, and in a manner that
  457  constitutes a danger to the health or well-being of blood donors
  458  or recipients as evidenced by the federal Food and Drug
  459  Administration’s inspection process is declared a nuisance and
  460  inimical to the public health, welfare, and safety. The Agency
  461  for Health Care Administration or any state attorney may bring
  462  an action for an injunction to restrain such operations or
  463  enjoin the future operation of the blood establishment.
  464         (5) A blood establishment that collects blood or blood
  465  components from volunteer donors must disclose on the Internet
  466  information to educate and inform donors and the public about
  467  the blood establishment’s activities. A hospital that collects
  468  blood or blood components from volunteer donors for its own use
  469  or for health care providers that are part of its business
  470  entity is exempt from the disclosure requirements in this
  471  subsection. The information required to be disclosed under this
  472  subsection may be cumulative for all blood establishments within
  473  a business entity. Disciplinary action against the blood
  474  establishment’s clinical laboratory license may be taken as
  475  provided in s. 483.201 for a blood establishment that is
  476  required to disclose but fails to disclose on its website all of
  477  the following information:
  478         (a) A description of the steps involved in collecting,
  479  processing, and distributing volunteer donations, presented in a
  480  manner appropriate for the donating public.
  481         (b) By March 1 of each year, the number of units of blood
  482  components, identified by component, that were:
  483         1. Produced by the blood establishment during the preceding
  484  calendar year;
  485         2. Obtained from other sources during the preceding
  486  calendar year;
  487         3. Distributed during the preceding year to health care
  488  providers located outside this state. However, if the blood
  489  establishment collects donations in a county outside this state,
  490  distributions to health care providers in that county shall be
  491  excluded. Such information shall be aggregated by health care
  492  providers located within the United States and its territories
  493  or outside the United States and its territories; and
  494         4. Distributed to entities that are not health care
  495  providers during the preceding year. Such information shall be
  496  aggregated by purchasers located within the United States and
  497  its territories or outside the United States and its
  498  territories.
  499  
  500  For purposes of this paragraph, the components that must be
  501  reported include whole blood, red blood cells, leukoreduced red
  502  blood cells, fresh frozen plasma or the equivalent, recovered
  503  plasma, platelets, and cryoprecipitated antihemophilic factor.
  504         (c) The blood establishment’s conflict-of-interest policy,
  505  policy concerning related-party transactions, whistleblower
  506  policy, and policy for determining executive compensation. If a
  507  change to any of these documents occurs, the revised document
  508  must be available on the blood establishment’s website by the
  509  following March 1.
  510         (d)1. The most recent 3 years of the Return of Organization
  511  Exempt from Income Tax, Internal Revenue Service Form 990, if
  512  the business entity for the blood establishment is eligible to
  513  file such return. The Form 990 must be available on the blood
  514  establishment’s website within 30 calendar days after filing it
  515  with the Internal Revenue Service; or
  516         2. If the business entity for the blood establishment is
  517  not eligible to file the Form 990 return, a balance sheet,
  518  income statement, statement of changes in cash flow, and the
  519  expression of an opinion thereon by an independent certified
  520  public accountant who audited or reviewed such financial
  521  statements. Such documents must be available on the blood
  522  establishment’s website within 120 days after the end of the
  523  blood establishment’s fiscal year and must remain on the blood
  524  establishment’s website for at least 36 months.
  525         Section 7. Section 383.325, Florida Statutes, is repealed.
  526         Section 8. Subsection (7) of section 394.4787, Florida
  527  Statutes, is amended to read:
  528         394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and
  529  394.4789.—As used in this section and ss. 394.4786, 394.4788,
  530  and 394.4789:
  531         (7) “Specialty psychiatric hospital” means a hospital
  532  licensed by the agency pursuant to s. 395.002(26)(28) and part
  533  II of chapter 408 as a specialty psychiatric hospital.
  534         Section 9. Subsection (2) of section 394.741, Florida
  535  Statutes, is amended to read:
  536         394.741 Accreditation requirements for providers of
  537  behavioral health care services.—
  538         (2) Notwithstanding any provision of law to the contrary,
  539  accreditation shall be accepted by the agency and department in
  540  lieu of the agency’s and department’s facility licensure onsite
  541  review requirements and shall be accepted as a substitute for
  542  the department’s administrative and program monitoring
  543  requirements, except as required by subsections (3) and (4),
  544  for:
  545         (a) Any organization from which the department purchases
  546  behavioral health care services that is accredited by The Joint
  547  Commission on Accreditation of Healthcare Organizations or the
  548  Council on Accreditation for Children and Family Services, or
  549  has those services that are being purchased by the department
  550  accredited by the Commission on Accreditation of Rehabilitation
  551  Facilities CARF—the Rehabilitation Accreditation Commission.
  552         (b) Any mental health facility licensed by the agency or
  553  any substance abuse component licensed by the department that is
  554  accredited by The Joint Commission on Accreditation of
  555  Healthcare Organizations, the Commission on Accreditation of
  556  Rehabilitation Facilities CARF—the Rehabilitation Accreditation
  557  Commission, or the Council on Accreditation of Children and
  558  Family Services.
  559         (c) Any network of providers from which the department or
  560  the agency purchases behavioral health care services accredited
  561  by The Joint Commission on Accreditation of Healthcare
  562  Organizations, the Commission on Accreditation of Rehabilitation
  563  Facilities CARF—the Rehabilitation Accreditation Commission, the
  564  Council on Accreditation of Children and Family Services, or the
  565  National Committee for Quality Assurance. A provider
  566  organization, which is part of an accredited network, is
  567  afforded the same rights under this part.
  568         Section 10. Present subsections (15) through (32) of
  569  section 395.002, Florida Statutes, are renumbered as subsections
  570  (14) through (28), respectively, and present subsections (1),
  571  (14), (24), (30), and (31), and paragraph (c) of present
  572  subsection (28) of that section are amended to read:
  573         395.002 Definitions.—As used in this chapter:
  574         (1) “Accrediting organizations” means nationally recognized
  575  or approved accrediting organizations whose standards
  576  incorporate comparable licensure requirements as determined by
  577  the agency the Joint Commission on Accreditation of Healthcare
  578  Organizations, the American Osteopathic Association, the
  579  Commission on Accreditation of Rehabilitation Facilities, and
  580  the Accreditation Association for Ambulatory Health Care, Inc.
  581         (14)“Initial denial determination” means a determination
  582  by a private review agent that the health care services
  583  furnished or proposed to be furnished to a patient are
  584  inappropriate, not medically necessary, or not reasonable.
  585         (24)“Private review agent” means any person or entity
  586  which performs utilization review services for third-party
  587  payors on a contractual basis for outpatient or inpatient
  588  services. However, the term shall not include full-time
  589  employees, personnel, or staff of health insurers, health
  590  maintenance organizations, or hospitals, or wholly owned
  591  subsidiaries thereof or affiliates under common ownership, when
  592  performing utilization review for their respective hospitals,
  593  health maintenance organizations, or insureds of the same
  594  insurance group. For this purpose, health insurers, health
  595  maintenance organizations, and hospitals, or wholly owned
  596  subsidiaries thereof or affiliates under common ownership,
  597  include such entities engaged as administrators of self
  598  insurance as defined in s. 624.031.
  599         (26)(28) “Specialty hospital” means any facility which
  600  meets the provisions of subsection (12), and which regularly
  601  makes available either:
  602         (c) Intensive residential treatment programs for children
  603  and adolescents as defined in subsection (14) (15).
  604         (30)“Utilization review” means a system for reviewing the
  605  medical necessity or appropriateness in the allocation of health
  606  care resources of hospital services given or proposed to be
  607  given to a patient or group of patients.
  608         (31)“Utilization review plan” means a description of the
  609  policies and procedures governing utilization review activities
  610  performed by a private review agent.
  611         Section 11. Paragraph (c) of subsection (1) and paragraph
  612  (b) of subsection (2) of section 395.003, Florida Statutes, are
  613  amended to read:
  614         395.003 Licensure; denial, suspension, and revocation.—
  615         (1)
  616         (c)Until July 1, 2006, additional emergency departments
  617  located off the premises of licensed hospitals may not be
  618  authorized by the agency.
  619         (2)
  620         (b) The agency shall, at the request of a licensee that is
  621  a teaching hospital as defined in s. 408.07(45), issue a single
  622  license to a licensee for facilities that have been previously
  623  licensed as separate premises, provided such separately licensed
  624  facilities, taken together, constitute the same premises as
  625  defined in s. 395.002(22)(23). Such license for the single
  626  premises shall include all of the beds, services, and programs
  627  that were previously included on the licenses for the separate
  628  premises. The granting of a single license under this paragraph
  629  shall not in any manner reduce the number of beds, services, or
  630  programs operated by the licensee.
  631         Section 12. Paragraph (e) of subsection (2) and subsection
  632  (4) of section 395.0193, Florida Statutes, are amended to read:
  633         395.0193 Licensed facilities; peer review; disciplinary
  634  powers; agency or partnership with physicians.—
  635         (2) Each licensed facility, as a condition of licensure,
  636  shall provide for peer review of physicians who deliver health
  637  care services at the facility. Each licensed facility shall
  638  develop written, binding procedures by which such peer review
  639  shall be conducted. Such procedures shall include:
  640         (e) Recording of agendas and minutes which do not contain
  641  confidential material, for review by the Division of Medical
  642  Quality Assurance of the department Health Quality Assurance of
  643  the agency.
  644         (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
  645  actions taken under subsection (3) shall be reported in writing
  646  to the Division of Medical Quality Assurance of the department
  647  Health Quality Assurance of the agency within 30 working days
  648  after its initial occurrence, regardless of the pendency of
  649  appeals to the governing board of the hospital. The notification
  650  shall identify the disciplined practitioner, the action taken,
  651  and the reason for such action. All final disciplinary actions
  652  taken under subsection (3), if different from those which were
  653  reported to the department agency within 30 days after the
  654  initial occurrence, shall be reported within 10 working days to
  655  the Division of Medical Quality Assurance of the department
  656  Health Quality Assurance of the agency in writing and shall
  657  specify the disciplinary action taken and the specific grounds
  658  therefor. The division shall review each report and determine
  659  whether it potentially involved conduct by the licensee that is
  660  subject to disciplinary action, in which case s. 456.073 shall
  661  apply. The reports are not subject to inspection under s.
  662  119.07(1) even if the division’s investigation results in a
  663  finding of probable cause.
  664         Section 13. Section 395.1023, Florida Statutes, is amended
  665  to read:
  666         395.1023 Child abuse and neglect cases; duties.—Each
  667  licensed facility shall adopt a protocol that, at a minimum,
  668  requires the facility to:
  669         (1) Incorporate a facility policy that every staff member
  670  has an affirmative duty to report, pursuant to chapter 39, any
  671  actual or suspected case of child abuse, abandonment, or
  672  neglect; and
  673         (2) In any case involving suspected child abuse,
  674  abandonment, or neglect, designate, at the request of the
  675  Department of Children and Family Services, a staff physician to
  676  act as a liaison between the hospital and the Department of
  677  Children and Family Services office which is investigating the
  678  suspected abuse, abandonment, or neglect, and the child
  679  protection team, as defined in s. 39.01, when the case is
  680  referred to such a team.
  681  
  682  Each general hospital and appropriate specialty hospital shall
  683  comply with the provisions of this section and shall notify the
  684  agency and the Department of Children and Family Services of its
  685  compliance by sending a copy of its policy to the agency and the
  686  Department of Children and Family Services as required by rule.
  687  The failure by a general hospital or appropriate specialty
  688  hospital to comply shall be punished by a fine not exceeding
  689  $1,000, to be fixed, imposed, and collected by the agency. Each
  690  day in violation is considered a separate offense.
  691         Section 14. Subsection (2) and paragraph (d) of subsection
  692  (3) of section 395.1041, Florida Statutes, are amended to read:
  693         395.1041 Access to emergency services and care.—
  694         (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
  695  shall establish and maintain an inventory of hospitals with
  696  emergency services. The inventory shall list all services within
  697  the service capability of the hospital, and such services shall
  698  appear on the face of the hospital license. Each hospital having
  699  emergency services shall notify the agency of its service
  700  capability in the manner and form prescribed by the agency. The
  701  agency shall use the inventory to assist emergency medical
  702  services providers and others in locating appropriate emergency
  703  medical care. The inventory shall also be made available to the
  704  general public. On or before August 1, 1992, the agency shall
  705  request that each hospital identify the services which are
  706  within its service capability. On or before November 1, 1992,
  707  the agency shall notify each hospital of the service capability
  708  to be included in the inventory. The hospital has 15 days from
  709  the date of receipt to respond to the notice. By December 1,
  710  1992, the agency shall publish a final inventory. Each hospital
  711  shall reaffirm its service capability when its license is
  712  renewed and shall notify the agency of the addition of a new
  713  service or the termination of a service prior to a change in its
  714  service capability.
  715         (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
  716  FACILITY OR HEALTH CARE PERSONNEL.—
  717         (d)1. Every hospital shall ensure the provision of services
  718  within the service capability of the hospital, at all times,
  719  either directly or indirectly through an arrangement with
  720  another hospital, through an arrangement with one or more
  721  physicians, or as otherwise made through prior arrangements. A
  722  hospital may enter into an agreement with another hospital for
  723  purposes of meeting its service capability requirement, and
  724  appropriate compensation or other reasonable conditions may be
  725  negotiated for these backup services.
  726         2. If any arrangement requires the provision of emergency
  727  medical transportation, such arrangement must be made in
  728  consultation with the applicable provider and may not require
  729  the emergency medical service provider to provide transportation
  730  that is outside the routine service area of that provider or in
  731  a manner that impairs the ability of the emergency medical
  732  service provider to timely respond to prehospital emergency
  733  calls.
  734         3. A hospital shall not be required to ensure service
  735  capability at all times as required in subparagraph 1. if, prior
  736  to the receiving of any patient needing such service capability,
  737  such hospital has demonstrated to the agency that it lacks the
  738  ability to ensure such capability and it has exhausted all
  739  reasonable efforts to ensure such capability through backup
  740  arrangements. In reviewing a hospital’s demonstration of lack of
  741  ability to ensure service capability, the agency shall consider
  742  factors relevant to the particular case, including the
  743  following:
  744         a. Number and proximity of hospitals with the same service
  745  capability.
  746         b. Number, type, credentials, and privileges of
  747  specialists.
  748         c. Frequency of procedures.
  749         d. Size of hospital.
  750         4. The agency shall publish proposed rules implementing a
  751  reasonable exemption procedure by November 1, 1992. Subparagraph
  752  1. shall become effective upon the effective date of said rules
  753  or January 31, 1993, whichever is earlier. For a period not to
  754  exceed 1 year from the effective date of subparagraph 1., a
  755  hospital requesting an exemption shall be deemed to be exempt
  756  from offering the service until the agency initially acts to
  757  deny or grant the original request. The agency has 45 days from
  758  the date of receipt of the request to approve or deny the
  759  request. After the first year from the effective date of
  760  subparagraph 1., If the agency fails to initially act within the
  761  time period, the hospital is deemed to be exempt from offering
  762  the service until the agency initially acts to deny the request.
  763         Section 15. Section 395.1046, Florida Statutes, is
  764  repealed.
  765         Section 16. Paragraph (e) of subsection (1) of section
  766  395.1055, Florida Statutes, is amended to read:
  767         395.1055 Rules and enforcement.—
  768         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
  769  and 120.54 to implement the provisions of this part, which shall
  770  include reasonable and fair minimum standards for ensuring that:
  771         (e) Licensed facility beds conform to minimum space,
  772  equipment, and furnishings standards as specified by the agency,
  773  the Florida Building Code, and the Florida Fire Prevention Code
  774  department.
  775         Section 17. Subsection (1) of section 395.10972, Florida
  776  Statutes, is amended to read:
  777         395.10972 Health Care Risk Manager Advisory Council.—The
  778  Secretary of Health Care Administration may appoint a seven
  779  member advisory council to advise the agency on matters
  780  pertaining to health care risk managers. The members of the
  781  council shall serve at the pleasure of the secretary. The
  782  council shall designate a chair. The council shall meet at the
  783  call of the secretary or at those times as may be required by
  784  rule of the agency. The members of the advisory council shall
  785  receive no compensation for their services, but shall be
  786  reimbursed for travel expenses as provided in s. 112.061. The
  787  council shall consist of individuals representing the following
  788  areas:
  789         (1) Two shall be active health care risk managers,
  790  including one risk manager who is recommended by and a member of
  791  the Florida Society for of Healthcare Risk Management and
  792  Patient Safety.
  793         Section 18. Subsection (3) of section 395.2050, Florida
  794  Statutes, is amended to read:
  795         395.2050 Routine inquiry for organ and tissue donation;
  796  certification for procurement activities; death records review.—
  797         (3) Each organ procurement organization designated by the
  798  federal Centers for Medicare and Medicaid Services Health Care
  799  Financing Administration and licensed by the state shall conduct
  800  an annual death records review in the organ procurement
  801  organization’s affiliated donor hospitals. The organ procurement
  802  organization shall enlist the services of every Florida licensed
  803  tissue bank and eye bank affiliated with or providing service to
  804  the donor hospital and operating in the same service area to
  805  participate in the death records review.
  806         Section 19. Subsection (2) of section 395.3036, Florida
  807  Statutes, is amended to read:
  808         395.3036 Confidentiality of records and meetings of
  809  corporations that lease public hospitals or other public health
  810  care facilities.—The records of a private corporation that
  811  leases a public hospital or other public health care facility
  812  are confidential and exempt from the provisions of s. 119.07(1)
  813  and s. 24(a), Art. I of the State Constitution, and the meetings
  814  of the governing board of a private corporation are exempt from
  815  s. 286.011 and s. 24(b), Art. I of the State Constitution when
  816  the public lessor complies with the public finance
  817  accountability provisions of s. 155.40(5) with respect to the
  818  transfer of any public funds to the private lessee and when the
  819  private lessee meets at least three of the five following
  820  criteria:
  821         (2) The public lessor and the private lessee do not
  822  commingle any of their funds in any account maintained by either
  823  of them, other than the payment of the rent and administrative
  824  fees or the transfer of funds pursuant to s. 155.40(2)
  825  subsection (2).
  826         Section 20. Section 395.3037, Florida Statutes, is
  827  repealed.
  828         Section 21. Subsections (1), (4), and (5) of section
  829  395.3038, Florida Statutes, are amended to read:
  830         395.3038 State-listed primary stroke centers and
  831  comprehensive stroke centers; notification of hospitals.—
  832         (1) The agency shall make available on its website and to
  833  the department a list of the name and address of each hospital
  834  that meets the criteria for a primary stroke center and the name
  835  and address of each hospital that meets the criteria for a
  836  comprehensive stroke center. The list of primary and
  837  comprehensive stroke centers shall include only those hospitals
  838  that attest in an affidavit submitted to the agency that the
  839  hospital meets the named criteria, or those hospitals that
  840  attest in an affidavit submitted to the agency that the hospital
  841  is certified as a primary or a comprehensive stroke center by
  842  The Joint Commission on Accreditation of Healthcare
  843  Organizations.
  844         (4) The agency shall adopt by rule criteria for a primary
  845  stroke center which are substantially similar to the
  846  certification standards for primary stroke centers of The Joint
  847  Commission on Accreditation of Healthcare Organizations.
  848         (5) The agency shall adopt by rule criteria for a
  849  comprehensive stroke center. However, if The Joint Commission on
  850  Accreditation of Healthcare Organizations establishes criteria
  851  for a comprehensive stroke center, the agency shall establish
  852  criteria for a comprehensive stroke center which are
  853  substantially similar to those criteria established by The Joint
  854  Commission on Accreditation of Healthcare Organizations.
  855         Section 22. Paragraph (e) of subsection (2) of section
  856  395.602, Florida Statutes, is amended to read:
  857         395.602 Rural hospitals.—
  858         (2) DEFINITIONS.—As used in this part:
  859         (e) “Rural hospital” means an acute care hospital licensed
  860  under this chapter, having 100 or fewer licensed beds and an
  861  emergency room, which is:
  862         1. The sole provider within a county with a population
  863  density of no greater than 100 persons per square mile;
  864         2. An acute care hospital, in a county with a population
  865  density of no greater than 100 persons per square mile, which is
  866  at least 30 minutes of travel time, on normally traveled roads
  867  under normal traffic conditions, from any other acute care
  868  hospital within the same county;
  869         3. A hospital supported by a tax district or subdistrict
  870  whose boundaries encompass a population of 100 persons or fewer
  871  per square mile;
  872         4.A hospital in a constitutional charter county with a
  873  population of over 1 million persons that has imposed a local
  874  option health service tax pursuant to law and in an area that
  875  was directly impacted by a catastrophic event on August 24,
  876  1992, for which the Governor of Florida declared a state of
  877  emergency pursuant to chapter 125, and has 120 beds or less that
  878  serves an agricultural community with an emergency room
  879  utilization of no less than 20,000 visits and a Medicaid
  880  inpatient utilization rate greater than 15 percent;
  881         4.5. A hospital with a service area that has a population
  882  of 100 persons or fewer per square mile. As used in this
  883  subparagraph, the term “service area” means the fewest number of
  884  zip codes that account for 75 percent of the hospital’s
  885  discharges for the most recent 5-year period, based on
  886  information available from the hospital inpatient discharge
  887  database in the Florida Center for Health Information and Policy
  888  Analysis at the Agency for Health Care Administration; or
  889         5.6. A hospital designated as a critical access hospital,
  890  as defined in s. 408.07(15).
  891  
  892  Population densities used in this paragraph must be based upon
  893  the most recently completed United States census. A hospital
  894  that received funds under s. 409.9116 for a quarter beginning no
  895  later than July 1, 2002, is deemed to have been and shall
  896  continue to be a rural hospital from that date through June 30,
  897  2015, if the hospital continues to have 100 or fewer licensed
  898  beds and an emergency room, or meets the criteria of
  899  subparagraph 4. An acute care hospital that has not previously
  900  been designated as a rural hospital and that meets the criteria
  901  of this paragraph shall be granted such designation upon
  902  application, including supporting documentation to the Agency
  903  for Health Care Administration.
  904         Section 23. Subsection (8) of section 400.021, Florida
  905  Statutes, is amended to read:
  906         400.021 Definitions.—When used in this part, unless the
  907  context otherwise requires, the term:
  908         (8) “Geriatric outpatient clinic” means a site for
  909  providing outpatient health care to persons 60 years of age or
  910  older, which is staffed by a registered nurse or a physician
  911  assistant, or a licensed practical nurse under the direct
  912  supervision of a registered nurse, advanced registered nurse
  913  practitioner, or physician.
  914         Section 24. Paragraph (g) of subsection (2) of section
  915  400.0239, Florida Statutes, is amended to read:
  916         400.0239 Quality of Long-Term Care Facility Improvement
  917  Trust Fund.—
  918         (2) Expenditures from the trust fund shall be allowable for
  919  direct support of the following:
  920         (g) Other initiatives authorized by the Centers for
  921  Medicare and Medicaid Services for the use of federal civil
  922  monetary penalties, including projects recommended through the
  923  Medicaid “Up-or-Out” Quality of Care Contract Management Program
  924  pursuant to s. 400.148.
  925         Section 25. Subsection (15) of section 400.0255, Florida
  926  Statutes, is amended to read
  927         400.0255 Resident transfer or discharge; requirements and
  928  procedures; hearings.—
  929         (15)(a) The department’s Office of Appeals Hearings shall
  930  conduct hearings under this section. The office shall notify the
  931  facility of a resident’s request for a hearing.
  932         (b) The department shall, by rule, establish procedures to
  933  be used for fair hearings requested by residents. These
  934  procedures shall be equivalent to the procedures used for fair
  935  hearings for other Medicaid cases appearing in s. 409.285 and
  936  applicable rules, chapter 10-2, part VI, Florida Administrative
  937  Code. The burden of proof must be clear and convincing evidence.
  938  A hearing decision must be rendered within 90 days after receipt
  939  of the request for hearing.
  940         (c) If the hearing decision is favorable to the resident
  941  who has been transferred or discharged, the resident must be
  942  readmitted to the facility’s first available bed.
  943         (d) The decision of the hearing officer shall be final. Any
  944  aggrieved party may appeal the decision to the district court of
  945  appeal in the appellate district where the facility is located.
  946  Review procedures shall be conducted in accordance with the
  947  Florida Rules of Appellate Procedure.
  948         Section 26. Subsection (2) of section 400.063, Florida
  949  Statutes, is amended to read:
  950         400.063 Resident protection.—
  951         (2) The agency is authorized to establish for each
  952  facility, subject to intervention by the agency, a separate bank
  953  account for the deposit to the credit of the agency of any
  954  moneys received from the Health Care Trust Fund or any other
  955  moneys received for the maintenance and care of residents in the
  956  facility, and the agency is authorized to disburse moneys from
  957  such account to pay obligations incurred for the purposes of
  958  this section. The agency is authorized to requisition moneys
  959  from the Health Care Trust Fund in advance of an actual need for
  960  cash on the basis of an estimate by the agency of moneys to be
  961  spent under the authority of this section. Any bank account
  962  established under this section need not be approved in advance
  963  of its creation as required by s. 17.58, but shall be secured by
  964  depository insurance equal to or greater than the balance of
  965  such account or by the pledge of collateral security in
  966  conformance with criteria established in s. 18.11. The agency
  967  shall notify the Chief Financial Officer of any such account so
  968  established and shall make a quarterly accounting to the Chief
  969  Financial Officer for all moneys deposited in such account.
  970         Section 27. Subsections (1) and (5) of section 400.071,
  971  Florida Statutes, are amended to read:
  972         400.071 Application for license.—
  973         (1) In addition to the requirements of part II of chapter
  974  408, the application for a license shall be under oath and must
  975  contain the following:
  976         (a) The location of the facility for which a license is
  977  sought and an indication, as in the original application, that
  978  such location conforms to the local zoning ordinances.
  979         (b)A signed affidavit disclosing any financial or
  980  ownership interest that a controlling interest as defined in
  981  part II of chapter 408 has held in the last 5 years in any
  982  entity licensed by this state or any other state to provide
  983  health or residential care which has closed voluntarily or
  984  involuntarily; has filed for bankruptcy; has had a receiver
  985  appointed; has had a license denied, suspended, or revoked; or
  986  has had an injunction issued against it which was initiated by a
  987  regulatory agency. The affidavit must disclose the reason any
  988  such entity was closed, whether voluntarily or involuntarily.
  989         (c)The total number of beds and the total number of
  990  Medicare and Medicaid certified beds.
  991         (b)(d) Information relating to the applicant and employees
  992  which the agency requires by rule. The applicant must
  993  demonstrate that sufficient numbers of qualified staff, by
  994  training or experience, will be employed to properly care for
  995  the type and number of residents who will reside in the
  996  facility.
  997         (c)(e) Copies of any civil verdict or judgment involving
  998  the applicant rendered within the 10 years preceding the
  999  application, relating to medical negligence, violation of
 1000  residents’ rights, or wrongful death. As a condition of
 1001  licensure, the licensee agrees to provide to the agency copies
 1002  of any new verdict or judgment involving the applicant, relating
 1003  to such matters, within 30 days after filing with the clerk of
 1004  the court. The information required in this paragraph shall be
 1005  maintained in the facility’s licensure file and in an agency
 1006  database which is available as a public record.
 1007         (5) As a condition of licensure, each facility must
 1008  establish and submit with its application a plan for quality
 1009  assurance and for conducting risk management.
 1010         Section 28. Section 400.0712, Florida Statutes, is amended
 1011  to read:
 1012         400.0712 Application for inactive license.—
 1013         (1)As specified in this section, the agency may issue an
 1014  inactive license to a nursing home facility for all or a portion
 1015  of its beds. Any request by a licensee that a nursing home or
 1016  portion of a nursing home become inactive must be submitted to
 1017  the agency in the approved format. The facility may not initiate
 1018  any suspension of services, notify residents, or initiate
 1019  inactivity before receiving approval from the agency; and a
 1020  licensee that violates this provision may not be issued an
 1021  inactive license.
 1022         (1)(2)In addition to the powers granted under part II of
 1023  chapter 408, the agency may issue an inactive license to a
 1024  nursing home that chooses to use an unoccupied contiguous
 1025  portion of the facility for an alternative use to meet the needs
 1026  of elderly persons through the use of less restrictive, less
 1027  institutional services.
 1028         (a) An inactive license issued under this subsection may be
 1029  granted for a period not to exceed the current licensure
 1030  expiration date but may be renewed by the agency at the time of
 1031  licensure renewal.
 1032         (b) A request to extend the inactive license must be
 1033  submitted to the agency in the approved format and approved by
 1034  the agency in writing.
 1035         (c) Nursing homes that receive an inactive license to
 1036  provide alternative services shall not receive preference for
 1037  participation in the Assisted Living for the Elderly Medicaid
 1038  waiver.
 1039         (2)(3) The agency shall adopt rules pursuant to ss.
 1040  120.536(1) and 120.54 necessary to implement this section.
 1041         Section 29. Section 400.111, Florida Statutes, is amended
 1042  to read:
 1043         400.111 Disclosure of controlling interest.—In addition to
 1044  the requirements of part II of chapter 408, when requested by
 1045  the agency, the licensee shall submit a signed affidavit
 1046  disclosing any financial or ownership interest that a
 1047  controlling interest has held within the last 5 years in any
 1048  entity licensed by the state or any other state to provide
 1049  health or residential care which entity has closed voluntarily
 1050  or involuntarily; has filed for bankruptcy; has had a receiver
 1051  appointed; has had a license denied, suspended, or revoked; or
 1052  has had an injunction issued against it which was initiated by a
 1053  regulatory agency. The affidavit must disclose the reason such
 1054  entity was closed, whether voluntarily or involuntarily.
 1055         Section 30. Subsection (2) of section 400.1183, Florida
 1056  Statutes, is amended to read:
 1057         400.1183 Resident grievance procedures.—
 1058         (2) Each facility shall maintain records of all grievances
 1059  for agency inspection and shall report to the agency at the time
 1060  of relicensure the total number of grievances handled during the
 1061  prior licensure period, a categorization of the cases underlying
 1062  the grievances, and the final disposition of the grievances.
 1063         Section 31. Paragraphs (o) through (w) of subsection (1) of
 1064  section 400.141, Florida Statutes, are redesignated as
 1065  paragraphs (n) through (u), respectively, and present paragraphs
 1066  (f), (g), (j), (n), (o), and (r) of that subsection are amended,
 1067  to read:
 1068         400.141 Administration and management of nursing home
 1069  facilities.—
 1070         (1) Every licensed facility shall comply with all
 1071  applicable standards and rules of the agency and shall:
 1072         (f) Be allowed and encouraged by the agency to provide
 1073  other needed services under certain conditions. If the facility
 1074  has a standard licensure status, and has had no class I or class
 1075  II deficiencies during the past 2 years or has been awarded a
 1076  Gold Seal under the program established in s. 400.235, it may be
 1077  encouraged by the agency to provide services, including, but not
 1078  limited to, respite and adult day services, which enable
 1079  individuals to move in and out of the facility. A facility is
 1080  not subject to any additional licensure requirements for
 1081  providing these services.
 1082         1. Respite care may be offered to persons in need of short
 1083  term or temporary nursing home services. For each person
 1084  admitted under the respite care program, the facility licensee
 1085  must:
 1086         a.Have a written abbreviated plan of care that, at a
 1087  minimum, includes nutritional requirements, medication orders,
 1088  physician orders, nursing assessments, and dietary preferences.
 1089  The nursing or physician assessments may take the place of all
 1090  other assessments required for full-time residents.
 1091         b.Have a contract that, at a minimum, specifies the
 1092  services to be provided to the respite resident, including
 1093  charges for services, activities, equipment, emergency medical
 1094  services, and the administration of medications. If multiple
 1095  respite admissions for a single person are anticipated, the
 1096  original contract is valid for 1 year after the date of
 1097  execution.
 1098         c.Ensure that each resident is released to his or her
 1099  caregiver or an individual designated in writing by the
 1100  caregiver.
 1101         2.A person admitted under the respite care program is:
 1102         a.Exempt from requirements in rule related to discharge
 1103  planning.
 1104         b.Covered by the resident’s rights set forth in s.
 1105  400.022(1)(a)-(o) and (r)-(t). Funds or property of the resident
 1106  shall not be considered trust funds subject to the requirements
 1107  of s. 400.022(1)(h) until the resident has been in the facility
 1108  for more than 14 consecutive days.
 1109         c.Allowed to use his or her personal medications for the
 1110  respite stay if permitted by facility policy. The facility must
 1111  obtain a physician’s orders for the medications. The caregiver
 1112  may provide information regarding the medications as part of the
 1113  nursing assessment, which must agree with the physician’s
 1114  orders. Medications shall be released with the resident upon
 1115  discharge in accordance with current orders.
 1116         3.A person receiving respite care is entitled to a total
 1117  of 60 days in the facility within a contract year or a calendar
 1118  year if the contract is for less than 12 months. However, each
 1119  single stay may not exceed 14 days. If a stay exceeds 14
 1120  consecutive days, the facility must comply with all assessment
 1121  and care planning requirements applicable to nursing home
 1122  residents.
 1123         4.A person receiving respite care must reside in a
 1124  licensed nursing home bed.
 1125         5.A prospective respite resident must provide medical
 1126  information from a physician, a physician assistant, or a nurse
 1127  practitioner and other information from the primary caregiver as
 1128  may be required by the facility prior to or at the time of
 1129  admission to receive respite care. The medical information must
 1130  include a physician’s order for respite care and proof of a
 1131  physical examination by a licensed physician, physician
 1132  assistant, or nurse practitioner. The physician’s order and
 1133  physical examination may be used to provide intermittent respite
 1134  care for up to 12 months after the date the order is written.
 1135         6.The facility must assume the duties of the primary
 1136  caregiver. To ensure continuity of care and services, the
 1137  resident is entitled to retain his or her personal physician and
 1138  must have access to medically necessary services such as
 1139  physical therapy, occupational therapy, or speech therapy, as
 1140  needed. The facility must arrange for transportation to these
 1141  services if necessary. Respite care must be provided in
 1142  accordance with this part and rules adopted by the agency.
 1143  However, the agency shall, by rule, adopt modified requirements
 1144  for resident assessment, resident care plans, resident
 1145  contracts, physician orders, and other provisions, as
 1146  appropriate, for short-term or temporary nursing home services.
 1147         7. The agency shall allow for shared programming and staff
 1148  in a facility which meets minimum standards and offers services
 1149  pursuant to this paragraph, but, if the facility is cited for
 1150  deficiencies in patient care, may require additional staff and
 1151  programs appropriate to the needs of service recipients. A
 1152  person who receives respite care may not be counted as a
 1153  resident of the facility for purposes of the facility’s licensed
 1154  capacity unless that person receives 24-hour respite care. A
 1155  person receiving either respite care for 24 hours or longer or
 1156  adult day services must be included when calculating minimum
 1157  staffing for the facility. Any costs and revenues generated by a
 1158  nursing home facility from nonresidential programs or services
 1159  shall be excluded from the calculations of Medicaid per diems
 1160  for nursing home institutional care reimbursement.
 1161         (g) If the facility has a standard license or is a Gold
 1162  Seal facility, exceeds the minimum required hours of licensed
 1163  nursing and certified nursing assistant direct care per resident
 1164  per day, and is part of a continuing care facility licensed
 1165  under chapter 651 or a retirement community that offers other
 1166  services pursuant to part III of this chapter or part I or part
 1167  III of chapter 429 on a single campus, be allowed to share
 1168  programming and staff. At the time of inspection and in the
 1169  semiannual report required pursuant to paragraph (n) (o), a
 1170  continuing care facility or retirement community that uses this
 1171  option must demonstrate through staffing records that minimum
 1172  staffing requirements for the facility were met. Licensed nurses
 1173  and certified nursing assistants who work in the nursing home
 1174  facility may be used to provide services elsewhere on campus if
 1175  the facility exceeds the minimum number of direct care hours
 1176  required per resident per day and the total number of residents
 1177  receiving direct care services from a licensed nurse or a
 1178  certified nursing assistant does not cause the facility to
 1179  violate the staffing ratios required under s. 400.23(3)(a).
 1180  Compliance with the minimum staffing ratios shall be based on
 1181  total number of residents receiving direct care services,
 1182  regardless of where they reside on campus. If the facility
 1183  receives a conditional license, it may not share staff until the
 1184  conditional license status ends. This paragraph does not
 1185  restrict the agency’s authority under federal or state law to
 1186  require additional staff if a facility is cited for deficiencies
 1187  in care which are caused by an insufficient number of certified
 1188  nursing assistants or licensed nurses. The agency may adopt
 1189  rules for the documentation necessary to determine compliance
 1190  with this provision.
 1191         (j) Keep full records of resident admissions and
 1192  discharges; medical and general health status, including medical
 1193  records, personal and social history, and identity and address
 1194  of next of kin or other persons who may have responsibility for
 1195  the affairs of the residents; and individual resident care plans
 1196  including, but not limited to, prescribed services, service
 1197  frequency and duration, and service goals. The records shall be
 1198  open to inspection by the agency. The facility must maintain
 1199  clinical records on each resident in accordance with accepted
 1200  professional standards and practices that are complete,
 1201  accurately documented, readily accessible, and systematically
 1202  organized.
 1203         (n)Submit to the agency the information specified in s.
 1204  400.071(1)(b) for a management company within 30 days after the
 1205  effective date of the management agreement.
 1206         (n)(o)1. Submit semiannually to the agency, or more
 1207  frequently if requested by the agency, information regarding
 1208  facility staff-to-resident ratios, staff turnover, and staff
 1209  stability, including information regarding certified nursing
 1210  assistants, licensed nurses, the director of nursing, and the
 1211  facility administrator. For purposes of this reporting:
 1212         a. Staff-to-resident ratios must be reported in the
 1213  categories specified in s. 400.23(3)(a) and applicable rules.
 1214  The ratio must be reported as an average for the most recent
 1215  calendar quarter.
 1216         b. Staff turnover must be reported for the most recent 12
 1217  month period ending on the last workday of the most recent
 1218  calendar quarter prior to the date the information is submitted.
 1219  The turnover rate must be computed quarterly, with the annual
 1220  rate being the cumulative sum of the quarterly rates. The
 1221  turnover rate is the total number of terminations or separations
 1222  experienced during the quarter, excluding any employee
 1223  terminated during a probationary period of 3 months or less,
 1224  divided by the total number of staff employed at the end of the
 1225  period for which the rate is computed, and expressed as a
 1226  percentage.
 1227         c. The formula for determining staff stability is the total
 1228  number of employees that have been employed for more than 12
 1229  months, divided by the total number of employees employed at the
 1230  end of the most recent calendar quarter, and expressed as a
 1231  percentage.
 1232         d. A nursing facility that has failed to comply with state
 1233  minimum-staffing requirements for 2 consecutive days is
 1234  prohibited from accepting new admissions until the facility has
 1235  achieved the minimum-staffing requirements for a period of 6
 1236  consecutive days. For the purposes of this sub-subparagraph, any
 1237  person who was a resident of the facility and was absent from
 1238  the facility for the purpose of receiving medical care at a
 1239  separate location or was on a leave of absence is not considered
 1240  a new admission. Failure to impose such an admissions moratorium
 1241  is subject to a $1,000 fine constitutes a class II deficiency.
 1242         e. A nursing facility which does not have a conditional
 1243  license may be cited for failure to comply with the standards in
 1244  s. 400.23(3)(a)1.a. only if it has failed to meet those
 1245  standards on 2 consecutive days or if it has failed to meet at
 1246  least 97 percent of those standards on any one day.
 1247         f. A facility which has a conditional license must be in
 1248  compliance with the standards in s. 400.23(3)(a) at all times.
 1249         2. This paragraph does not limit the agency’s ability to
 1250  impose a deficiency or take other actions if a facility does not
 1251  have enough staff to meet the residents’ needs.
 1252         (r)Report to the agency any filing for bankruptcy
 1253  protection by the facility or its parent corporation,
 1254  divestiture or spin-off of its assets, or corporate
 1255  reorganization within 30 days after the completion of such
 1256  activity.
 1257         Section 32. Subsection (3) of section 400.142, Florida
 1258  Statutes, is amended to read:
 1259         400.142 Emergency medication kits; orders not to
 1260  resuscitate.—
 1261         (3) Facility staff may withhold or withdraw cardiopulmonary
 1262  resuscitation if presented with an order not to resuscitate
 1263  executed pursuant to s. 401.45. The agency shall adopt rules
 1264  providing for the implementation of such orders. Facility staff
 1265  and facilities shall not be subject to criminal prosecution or
 1266  civil liability, nor be considered to have engaged in negligent
 1267  or unprofessional conduct, for withholding or withdrawing
 1268  cardiopulmonary resuscitation pursuant to such an order and
 1269  rules adopted by the agency. The absence of an order not to
 1270  resuscitate executed pursuant to s. 401.45 does not preclude a
 1271  physician from withholding or withdrawing cardiopulmonary
 1272  resuscitation as otherwise permitted by law.
 1273         Section 33. Subsections (11) through (15) of section
 1274  400.147, Florida Statutes, are renumbered as subsections (10)
 1275  through (14), respectively, and present subsection (10) is
 1276  amended to read:
 1277         400.147 Internal risk management and quality assurance
 1278  program.—
 1279         (10)By the 10th of each month, each facility subject to
 1280  this section shall report any notice received pursuant to s.
 1281  400.0233(2) and each initial complaint that was filed with the
 1282  clerk of the court and served on the facility during the
 1283  previous month by a resident or a resident’s family member,
 1284  guardian, conservator, or personal legal representative. The
 1285  report must include the name of the resident, the resident’s
 1286  date of birth and social security number, the Medicaid
 1287  identification number for Medicaid-eligible persons, the date or
 1288  dates of the incident leading to the claim or dates of
 1289  residency, if applicable, and the type of injury or violation of
 1290  rights alleged to have occurred. Each facility shall also submit
 1291  a copy of the notices received pursuant to s. 400.0233(2) and
 1292  complaints filed with the clerk of the court. This report is
 1293  confidential as provided by law and is not discoverable or
 1294  admissible in any civil or administrative action, except in such
 1295  actions brought by the agency to enforce the provisions of this
 1296  part.
 1297         Section 34. Section 400.148, Florida Statutes, is repealed.
 1298         Section 35. Paragraph (f) of subsection (5) of section
 1299  400.162, Florida Statutes, is amended to read:
 1300         400.162 Property and personal affairs of residents.—
 1301         (5)
 1302         (f) At least every 3 months, the licensee shall furnish the
 1303  resident and the guardian, trustee, or conservator, if any, for
 1304  the resident a complete and verified statement of all funds and
 1305  other property to which this subsection applies, detailing the
 1306  amounts and items received, together with their sources and
 1307  disposition. For resident property, the licensee shall furnish
 1308  such a statement annually and within 7 calendar days after a
 1309  request for a statement. In any event, the licensee shall
 1310  furnish such statements a statement annually and upon the
 1311  discharge or transfer of a resident. Any governmental agency or
 1312  private charitable agency contributing funds or other property
 1313  on account of a resident also shall be entitled to receive such
 1314  statements statement annually and upon discharge or transfer and
 1315  such other report as it may require pursuant to law.
 1316         Section 36. Paragraphs (d) and (e) of subsection (2) of
 1317  section 400.179, Florida Statutes, are amended to read:
 1318         400.179 Liability for Medicaid underpayments and
 1319  overpayments.—
 1320         (2) Because any transfer of a nursing facility may expose
 1321  the fact that Medicaid may have underpaid or overpaid the
 1322  transferor, and because in most instances, any such underpayment
 1323  or overpayment can only be determined following a formal field
 1324  audit, the liabilities for any such underpayments or
 1325  overpayments shall be as follows:
 1326         (d) Where the transfer involves a facility that has been
 1327  leased by the transferor:
 1328         1. The transferee shall, as a condition to being issued a
 1329  license by the agency, acquire, maintain, and provide proof to
 1330  the agency of a bond with a term of 30 months, renewable
 1331  annually, in an amount not less than the total of 3 months’
 1332  Medicaid payments to the facility computed on the basis of the
 1333  preceding 12-month average Medicaid payments to the facility.
 1334         2. A leasehold licensee may meet the requirements of
 1335  subparagraph 1. by payment of a nonrefundable fee, paid at
 1336  initial licensure, paid at the time of any subsequent change of
 1337  ownership, and paid annually thereafter, in the amount of 1
 1338  percent of the total of 3 months’ Medicaid payments to the
 1339  facility computed on the basis of the preceding 12-month average
 1340  Medicaid payments to the facility. If a preceding 12-month
 1341  average is not available, projected Medicaid payments may be
 1342  used. The fee shall be deposited into the Grants and Donations
 1343  Trust Fund and shall be accounted for separately as a Medicaid
 1344  nursing home overpayment account. These fees shall be used at
 1345  the sole discretion of the agency to repay nursing home Medicaid
 1346  overpayments. Payment of this fee shall not release the licensee
 1347  from any liability for any Medicaid overpayments, nor shall
 1348  payment bar the agency from seeking to recoup overpayments from
 1349  the licensee and any other liable party. As a condition of
 1350  exercising this lease bond alternative, licensees paying this
 1351  fee must maintain an existing lease bond through the end of the
 1352  30-month term period of that bond. The agency is herein granted
 1353  specific authority to promulgate all rules pertaining to the
 1354  administration and management of this account, including
 1355  withdrawals from the account, subject to federal review and
 1356  approval. This provision shall take effect upon becoming law and
 1357  shall apply to any leasehold license application. The financial
 1358  viability of the Medicaid nursing home overpayment account shall
 1359  be determined by the agency through annual review of the account
 1360  balance and the amount of total outstanding, unpaid Medicaid
 1361  overpayments owing from leasehold licensees to the agency as
 1362  determined by final agency audits. By March 31 of each year, the
 1363  agency shall assess the cumulative fees collected under this
 1364  subparagraph, minus any amounts used to repay nursing home
 1365  Medicaid overpayments and amounts transferred to contribute to
 1366  the General Revenue Fund pursuant to s. 215.20. If the net
 1367  cumulative collections, minus amounts utilized to repay nursing
 1368  home Medicaid overpayments, exceed $25 million, the provisions
 1369  of this paragraph shall not apply for the subsequent fiscal
 1370  year.
 1371         3. The leasehold licensee may meet the bond requirement
 1372  through other arrangements acceptable to the agency. The agency
 1373  is herein granted specific authority to promulgate rules
 1374  pertaining to lease bond arrangements.
 1375         4. All existing nursing facility licensees, operating the
 1376  facility as a leasehold, shall acquire, maintain, and provide
 1377  proof to the agency of the 30-month bond required in
 1378  subparagraph 1., above, on and after July 1, 1993, for each
 1379  license renewal.
 1380         5. It shall be the responsibility of all nursing facility
 1381  operators, operating the facility as a leasehold, to renew the
 1382  30-month bond and to provide proof of such renewal to the agency
 1383  annually.
 1384         6. Any failure of the nursing facility operator to acquire,
 1385  maintain, renew annually, or provide proof to the agency shall
 1386  be grounds for the agency to deny, revoke, and suspend the
 1387  facility license to operate such facility and to take any
 1388  further action, including, but not limited to, enjoining the
 1389  facility, asserting a moratorium pursuant to part II of chapter
 1390  408, or applying for a receiver, deemed necessary to ensure
 1391  compliance with this section and to safeguard and protect the
 1392  health, safety, and welfare of the facility’s residents. A lease
 1393  agreement required as a condition of bond financing or
 1394  refinancing under s. 154.213 by a health facilities authority or
 1395  required under s. 159.30 by a county or municipality is not a
 1396  leasehold for purposes of this paragraph and is not subject to
 1397  the bond requirement of this paragraph.
 1398         (e)For the 2009-2010 fiscal year only, the provisions of
 1399  paragraph (d) shall not apply. This paragraph expires July 1,
 1400  2010.
 1401         Section 37. Subsection (3) of section 400.19, Florida
 1402  Statutes, is amended to read:
 1403         400.19 Right of entry and inspection.—
 1404         (3) The agency shall every 15 months conduct at least one
 1405  unannounced inspection to determine compliance by the licensee
 1406  with statutes, and with rules promulgated under the provisions
 1407  of those statutes, governing minimum standards of construction,
 1408  quality and adequacy of care, and rights of residents. The
 1409  survey shall be conducted every 6 months for the next 2-year
 1410  period if the facility has been cited for a class I deficiency,
 1411  has been cited for two or more class II deficiencies arising
 1412  from separate surveys or investigations within a 60-day period,
 1413  or has had three or more substantiated complaints within a 6
 1414  month period, each resulting in at least one class I or class II
 1415  deficiency. In addition to any other fees or fines in this part,
 1416  the agency shall assess a fine for each facility that is subject
 1417  to the 6-month survey cycle. The fine for the 2-year period
 1418  shall be $6,000, one-half to be paid at the completion of each
 1419  survey. The agency may adjust this fine by the change in the
 1420  Consumer Price Index, based on the 12 months immediately
 1421  preceding the increase, to cover the cost of the additional
 1422  surveys. The agency shall verify through subsequent inspection
 1423  that any deficiency identified during inspection is corrected.
 1424  However, the agency may verify the correction of a class III or
 1425  class IV deficiency unrelated to resident rights or resident
 1426  care without reinspecting the facility if adequate written
 1427  documentation has been received from the facility, which
 1428  provides assurance that the deficiency has been corrected. The
 1429  giving or causing to be given of advance notice of such
 1430  unannounced inspections by an employee of the agency to any
 1431  unauthorized person shall constitute cause for suspension of not
 1432  fewer than 5 working days according to the provisions of chapter
 1433  110.
 1434         Section 38. Section 400.195, Florida Statutes, is repealed.
 1435         Section 39. Subsection (5) of section 400.23, Florida
 1436  Statutes, is amended to read:
 1437         400.23 Rules; evaluation and deficiencies; licensure
 1438  status.—
 1439         (5)(a) The agency, in collaboration with the Division of
 1440  Children’s Medical Services Network of the Department of Health,
 1441  must, no later than December 31, 1993, adopt rules for minimum
 1442  standards of care for persons under 21 years of age who reside
 1443  in nursing home facilities. The rules must include a methodology
 1444  for reviewing a nursing home facility under ss. 408.031-408.045
 1445  which serves only persons under 21 years of age. A facility may
 1446  be exempt from these standards for specific persons between 18
 1447  and 21 years of age, if the person’s physician agrees that
 1448  minimum standards of care based on age are not necessary.
 1449         (b)The agency, in collaboration with the Division of
 1450  Children’s Medical Services Network, shall adopt rules for
 1451  minimum staffing requirements for nursing home facilities that
 1452  serve persons under 21 years of age, which shall apply in lieu
 1453  of the standards contained in subsection (3).
 1454         1.For persons under 21 years of age who require skilled
 1455  care, the requirements shall include a minimum combined average
 1456  of licensed nurses, respiratory therapists, respiratory care
 1457  practitioners, and certified nursing assistants of 3.9 hours of
 1458  direct care per resident per day for each nursing home facility.
 1459         2.For persons under 21 years of age who are fragile, the
 1460  requirements shall include a minimum combined average of
 1461  licensed nurses, respiratory therapists, respiratory care
 1462  practitioners, and certified nursing assistants of 5 hours of
 1463  direct care per resident per day for each nursing home facility.
 1464         Section 40. Subsection (1) of section 400.275, Florida
 1465  Statutes, is amended to read:
 1466         400.275 Agency duties.—
 1467         (1) The agency shall ensure that each newly hired nursing
 1468  home surveyor, as a part of basic training, is assigned full
 1469  time to a licensed nursing home for at least 2 days within a 7
 1470  day period to observe facility operations outside of the survey
 1471  process before the surveyor begins survey responsibilities. Such
 1472  observations may not be the sole basis of a deficiency citation
 1473  against the facility. The agency may not assign an individual to
 1474  be a member of a survey team for purposes of a survey,
 1475  evaluation, or consultation visit at a nursing home facility in
 1476  which the surveyor was an employee within the preceding 2 5
 1477  years.
 1478         Section 41. Subsection (2) of section 400.484, Florida
 1479  Statutes, is amended to read:
 1480         400.484 Right of inspection; violations deficiencies;
 1481  fines.—
 1482         (2) The agency shall impose fines for various classes of
 1483  violations deficiencies in accordance with the following
 1484  schedule:
 1485         (a) Class I violations are defined in s. 408.813. A class I
 1486  deficiency is any act, omission, or practice that results in a
 1487  patient’s death, disablement, or permanent injury, or places a
 1488  patient at imminent risk of death, disablement, or permanent
 1489  injury. Upon finding a class I violation deficiency, the agency
 1490  shall impose an administrative fine in the amount of $15,000 for
 1491  each occurrence and each day that the violation deficiency
 1492  exists.
 1493         (b) Class II violations are defined in s. 408.813. A class
 1494  II deficiency is any act, omission, or practice that has a
 1495  direct adverse effect on the health, safety, or security of a
 1496  patient. Upon finding a class II violation deficiency, the
 1497  agency shall impose an administrative fine in the amount of
 1498  $5,000 for each occurrence and each day that the violation
 1499  deficiency exists.
 1500         (c) Class III violations are defined in s. 408.813. A class
 1501  III deficiency is any act, omission, or practice that has an
 1502  indirect, adverse effect on the health, safety, or security of a
 1503  patient. Upon finding an uncorrected or repeated class III
 1504  violation deficiency, the agency shall impose an administrative
 1505  fine not to exceed $1,000 for each occurrence and each day that
 1506  the uncorrected or repeated violation deficiency exists.
 1507         (d) Class IV violations are defined in s. 408.813. A class
 1508  IV deficiency is any act, omission, or practice related to
 1509  required reports, forms, or documents which does not have the
 1510  potential of negatively affecting patients. These violations are
 1511  of a type that the agency determines do not threaten the health,
 1512  safety, or security of patients. Upon finding an uncorrected or
 1513  repeated class IV violation deficiency, the agency shall impose
 1514  an administrative fine not to exceed $500 for each occurrence
 1515  and each day that the uncorrected or repeated violation
 1516  deficiency exists.
 1517         Section 42. Paragraph (i) of subsection (1) and subsection
 1518  (4) of section 400.606, Florida Statutes, are amended to read:
 1519         400.606 License; application; renewal; conditional license
 1520  or permit; certificate of need.—
 1521         (1) In addition to the requirements of part II of chapter
 1522  408, the initial application and change of ownership application
 1523  must be accompanied by a plan for the delivery of home,
 1524  residential, and homelike inpatient hospice services to
 1525  terminally ill persons and their families. Such plan must
 1526  contain, but need not be limited to:
 1527         (i)The projected annual operating cost of the hospice.
 1528  
 1529  If the applicant is an existing licensed health care provider,
 1530  the application must be accompanied by a copy of the most recent
 1531  profit-loss statement and, if applicable, the most recent
 1532  licensure inspection report.
 1533         (4) A freestanding hospice facility that is primarily
 1534  engaged in providing inpatient and related services and that is
 1535  not otherwise licensed as a health care facility shall be
 1536  required to obtain a certificate of need. However, a
 1537  freestanding hospice facility with six or fewer beds shall not
 1538  be required to comply with institutional standards such as, but
 1539  not limited to, standards requiring sprinkler systems, emergency
 1540  electrical systems, or special lavatory devices.
 1541         Section 43. Subsection (2) of section 400.607, Florida
 1542  Statutes, is amended to read:
 1543         400.607 Denial, suspension, revocation of license;
 1544  emergency actions; imposition of administrative fine; grounds.—
 1545         (2) A violation of this part, part II of chapter 408, or
 1546  applicable rules Any of the following actions by a licensed
 1547  hospice or any of its employees shall be grounds for
 1548  administrative action by the agency against a hospice.:
 1549         (a)A violation of the provisions of this part, part II of
 1550  chapter 408, or applicable rules.
 1551         (b)An intentional or negligent act materially affecting
 1552  the health or safety of a patient.
 1553         Section 44. Section 400.915, Florida Statutes, is amended
 1554  to read:
 1555         400.915 Construction and renovation; requirements.—The
 1556  requirements for the construction or renovation of a PPEC center
 1557  shall comply with:
 1558         (1) The provisions of chapter 553, which pertain to
 1559  building construction standards, including plumbing, electrical
 1560  code, glass, manufactured buildings, accessibility for the
 1561  physically disabled;
 1562         (2) The provisions of s. 633.022 and applicable rules
 1563  pertaining to physical minimum standards for nonresidential
 1564  child care physical facilities in rule 10M-12.003, Florida
 1565  Administrative Code, Child Care Standards; and
 1566         (3) The standards or rules adopted pursuant to this part
 1567  and part II of chapter 408.
 1568         Section 45. Subsection (1) of section 400.925, Florida
 1569  Statutes, is amended to read:
 1570         400.925 Definitions.—As used in this part, the term:
 1571         (1) “Accrediting organizations” means The Joint Commission
 1572  on Accreditation of Healthcare Organizations or other national
 1573  accreditation agencies whose standards for accreditation are
 1574  comparable to those required by this part for licensure.
 1575         Section 46. Subsections (3) through (6) of section 400.931,
 1576  Florida Statutes, are renumbered as subsections (2) through (5),
 1577  respectively, and present subsection (2) of that section is
 1578  amended to read:
 1579         400.931 Application for license; fee; provisional license;
 1580  temporary permit.—
 1581         (2)As an alternative to submitting proof of financial
 1582  ability to operate as required in s. 408.810(8), the applicant
 1583  may submit a $50,000 surety bond to the agency.
 1584         Section 47. Subsection (2) of section 400.932, Florida
 1585  Statutes, is amended to read:
 1586         400.932 Administrative penalties.—
 1587         (2) A violation of this part, part II of chapter 408, or
 1588  applicable rules Any of the following actions by an employee of
 1589  a home medical equipment provider shall be are grounds for
 1590  administrative action or penalties by the agency.:
 1591         (a)Violation of this part, part II of chapter 408, or
 1592  applicable rules.
 1593         (b)An intentional, reckless, or negligent act that
 1594  materially affects the health or safety of a patient.
 1595         Section 48. Subsection (3) of section 400.967, Florida
 1596  Statutes, is amended to read:
 1597         400.967 Rules and classification of violations
 1598  deficiencies.—
 1599         (3) The agency shall adopt rules to provide that, when the
 1600  criteria established under this part and part II of chapter 408
 1601  are not met, such violations deficiencies shall be classified
 1602  according to the nature of the violation deficiency. The agency
 1603  shall indicate the classification on the face of the notice of
 1604  deficiencies as follows:
 1605         (a) Class I violations deficiencies are defined in s.
 1606  408.813 those which the agency determines present an imminent
 1607  danger to the residents or guests of the facility or a
 1608  substantial probability that death or serious physical harm
 1609  would result therefrom. The condition or practice constituting a
 1610  class I violation must be abated or eliminated immediately,
 1611  unless a fixed period of time, as determined by the agency, is
 1612  required for correction. A class I violation deficiency is
 1613  subject to a civil penalty in an amount not less than $5,000 and
 1614  not exceeding $10,000 for each violation deficiency. A fine may
 1615  be levied notwithstanding the correction of the violation
 1616  deficiency.
 1617         (b) Class II violations deficiencies are defined in s.
 1618  408.813 those which the agency determines have a direct or
 1619  immediate relationship to the health, safety, or security of the
 1620  facility residents, other than class I deficiencies. A class II
 1621  violation deficiency is subject to a civil penalty in an amount
 1622  not less than $1,000 and not exceeding $5,000 for each violation
 1623  deficiency. A citation for a class II violation deficiency shall
 1624  specify the time within which the violation deficiency must be
 1625  corrected. If a class II violation deficiency is corrected
 1626  within the time specified, no civil penalty shall be imposed,
 1627  unless it is a repeated offense.
 1628         (c) Class III violations deficiencies are defined in s.
 1629  408.813 those which the agency determines to have an indirect or
 1630  potential relationship to the health, safety, or security of the
 1631  facility residents, other than class I or class II deficiencies.
 1632  A class III violation deficiency is subject to a civil penalty
 1633  of not less than $500 and not exceeding $1,000 for each
 1634  deficiency. A citation for a class III violation deficiency
 1635  shall specify the time within which the violation deficiency
 1636  must be corrected. If a class III violation deficiency is
 1637  corrected within the time specified, no civil penalty shall be
 1638  imposed, unless it is a repeated offense.
 1639         (d)Class IV violations are defined in s. 408.813. Upon
 1640  finding an uncorrected or repeated class IV violation, the
 1641  agency shall impose an administrative fine not to exceed $500
 1642  for each occurrence and each day that the uncorrected or
 1643  repeated violation exists.
 1644         Section 49. Subsections (4) and (7) of section 400.9905,
 1645  Florida Statutes, are amended to read:
 1646         400.9905 Definitions.—
 1647         (4) “Clinic” means an entity at which health care services
 1648  are provided to individuals and which tenders charges for
 1649  reimbursement for such services, including a mobile clinic and a
 1650  portable health service or equipment provider. For purposes of
 1651  this part, the term does not include and the licensure
 1652  requirements of this part do not apply to:
 1653         (a) Entities licensed or registered by the state under
 1654  chapter 395; or entities licensed or registered by the state and
 1655  providing only health care services within the scope of services
 1656  authorized under their respective licenses granted under ss.
 1657  383.30-383.335, chapter 390, chapter 394, chapter 397, this
 1658  chapter except part X, chapter 429, chapter 463, chapter 465,
 1659  chapter 466, chapter 478, part I of chapter 483, chapter 484, or
 1660  chapter 651; end-stage renal disease providers authorized under
 1661  42 C.F.R. part 405, subpart U; or providers certified under 42
 1662  C.F.R. part 485, subpart B or subpart H; or any entity that
 1663  provides neonatal or pediatric hospital-based health care
 1664  services or other health care services by licensed practitioners
 1665  solely within a hospital licensed under chapter 395.
 1666         (b) Entities that own, directly or indirectly, entities
 1667  licensed or registered by the state pursuant to chapter 395; or
 1668  entities that own, directly or indirectly, entities licensed or
 1669  registered by the state and providing only health care services
 1670  within the scope of services authorized pursuant to their
 1671  respective licenses granted under ss. 383.30-383.335, chapter
 1672  390, chapter 394, chapter 397, this chapter except part X,
 1673  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1674  part I of chapter 483, chapter 484, chapter 651; end-stage renal
 1675  disease providers authorized under 42 C.F.R. part 405, subpart
 1676  U; or providers certified under 42 C.F.R. part 485, subpart B or
 1677  subpart H; or any entity that provides neonatal or pediatric
 1678  hospital-based health care services by licensed practitioners
 1679  solely within a hospital licensed under chapter 395.
 1680         (c) Entities that are owned, directly or indirectly, by an
 1681  entity licensed or registered by the state pursuant to chapter
 1682  395; or entities that are owned, directly or indirectly, by an
 1683  entity licensed or registered by the state and providing only
 1684  health care services within the scope of services authorized
 1685  pursuant to their respective licenses granted under ss. 383.30
 1686  383.335, chapter 390, chapter 394, chapter 397, this chapter
 1687  except part X, chapter 429, chapter 463, chapter 465, chapter
 1688  466, chapter 478, part I of chapter 483, chapter 484, or chapter
 1689  651; end-stage renal disease providers authorized under 42
 1690  C.F.R. part 405, subpart U; or providers certified under 42
 1691  C.F.R. part 485, subpart B or subpart H; or any entity that
 1692  provides neonatal or pediatric hospital-based health care
 1693  services by licensed practitioners solely within a hospital
 1694  under chapter 395.
 1695         (d) Entities that are under common ownership, directly or
 1696  indirectly, with an entity licensed or registered by the state
 1697  pursuant to chapter 395; or entities that are under common
 1698  ownership, directly or indirectly, with an entity licensed or
 1699  registered by the state and providing only health care services
 1700  within the scope of services authorized pursuant to their
 1701  respective licenses granted under ss. 383.30-383.335, chapter
 1702  390, chapter 394, chapter 397, this chapter except part X,
 1703  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1704  part I of chapter 483, chapter 484, or chapter 651; end-stage
 1705  renal disease providers authorized under 42 C.F.R. part 405,
 1706  subpart U; or providers certified under 42 C.F.R. part 485,
 1707  subpart B or subpart H; or any entity that provides neonatal or
 1708  pediatric hospital-based health care services by licensed
 1709  practitioners solely within a hospital licensed under chapter
 1710  395.
 1711         (e) An entity that is exempt from federal taxation under 26
 1712  U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
 1713  under 26 U.S.C. s. 409 that has a board of trustees not less
 1714  than two-thirds of which are Florida-licensed health care
 1715  practitioners and provides only physical therapy services under
 1716  physician orders, any community college or university clinic,
 1717  and any entity owned or operated by the federal or state
 1718  government, including agencies, subdivisions, or municipalities
 1719  thereof.
 1720         (f) A sole proprietorship, group practice, partnership, or
 1721  corporation that provides health care services by physicians
 1722  covered by s. 627.419, that is directly supervised by one or
 1723  more of such physicians, and that is wholly owned by one or more
 1724  of those physicians or by a physician and the spouse, parent,
 1725  child, or sibling of that physician.
 1726         (g) A sole proprietorship, group practice, partnership, or
 1727  corporation that provides health care services by licensed
 1728  health care practitioners under chapter 457, chapter 458,
 1729  chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
 1730  chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
 1731  chapter 490, chapter 491, or part I, part III, part X, part
 1732  XIII, or part XIV of chapter 468, or s. 464.012, which are
 1733  wholly owned by one or more licensed health care practitioners,
 1734  or the licensed health care practitioners set forth in this
 1735  paragraph and the spouse, parent, child, or sibling of a
 1736  licensed health care practitioner, so long as one of the owners
 1737  who is a licensed health care practitioner is supervising the
 1738  business activities and is legally responsible for the entity’s
 1739  compliance with all federal and state laws. However, a health
 1740  care practitioner may not supervise services beyond the scope of
 1741  the practitioner’s license, except that, for the purposes of
 1742  this part, a clinic owned by a licensee in s. 456.053(3)(b) that
 1743  provides only services authorized pursuant to s. 456.053(3)(b)
 1744  may be supervised by a licensee specified in s. 456.053(3)(b).
 1745         (h) Clinical facilities affiliated with an accredited
 1746  medical school at which training is provided for medical
 1747  students, residents, or fellows.
 1748         (i) Entities that provide only oncology or radiation
 1749  therapy services by physicians licensed under chapter 458 or
 1750  chapter 459 or entities that provide oncology or radiation
 1751  therapy services by physicians licensed under chapter 458 or
 1752  chapter 459 which are owned by a corporation whose shares are
 1753  publicly traded on a recognized stock exchange.
 1754         (j) Clinical facilities affiliated with a college of
 1755  chiropractic accredited by the Council on Chiropractic Education
 1756  at which training is provided for chiropractic students.
 1757         (k) Entities that provide licensed practitioners to staff
 1758  emergency departments or to deliver anesthesia services in
 1759  facilities licensed under chapter 395 and that derive at least
 1760  90 percent of their gross annual revenues from the provision of
 1761  such services. Entities claiming an exemption from licensure
 1762  under this paragraph must provide documentation demonstrating
 1763  compliance.
 1764         (l) Orthotic, or prosthetic, pediatric cardiology, or
 1765  perinatology clinical facilities that are a publicly traded
 1766  corporation or that are wholly owned, directly or indirectly, by
 1767  a publicly traded corporation. As used in this paragraph, a
 1768  publicly traded corporation is a corporation that issues
 1769  securities traded on an exchange registered with the United
 1770  States Securities and Exchange Commission as a national
 1771  securities exchange.
 1772         (m)Entities that are owned by a corporation that has $250
 1773  million or more in total annual sales of health care services
 1774  provided by licensed health care practitioners if one or more of
 1775  the owners of the entity is a health care practitioner who is
 1776  licensed in this state, is responsible for supervising the
 1777  business activities of the entity, and is legally responsible
 1778  for the entity’s compliance with state law for purposes of this
 1779  section.
 1780         (n)Entities that are owned or controlled, directly or
 1781  indirectly, by a publicly traded entity with $100 million or
 1782  more, in the aggregate, in total annual revenues derived from
 1783  providing health care services by licensed health care
 1784  practitioners that are employed or contracted by an entity
 1785  described in this paragraph.
 1786         (7) “Portable health service or equipment provider” means
 1787  an entity that contracts with or employs persons to provide
 1788  portable health care services or equipment to multiple locations
 1789  performing treatment or diagnostic testing of individuals, that
 1790  bills third-party payors for those services, and that otherwise
 1791  meets the definition of a clinic in subsection (4).
 1792         Section 50. Paragraph (b) of subsection (1) and paragraph
 1793  (c) of subsection (4) of section 400.991, Florida Statutes, are
 1794  amended to read:
 1795         400.991 License requirements; background screenings;
 1796  prohibitions.—
 1797         (1)
 1798         (b) Each mobile clinic must obtain a separate health care
 1799  clinic license and must provide to the agency, at least
 1800  quarterly, its projected street location to enable the agency to
 1801  locate and inspect such clinic. A portable health service or
 1802  equipment provider must obtain a health care clinic license for
 1803  a single administrative office and is not required to submit
 1804  quarterly projected street locations.
 1805         (4) In addition to the requirements of part II of chapter
 1806  408, the applicant must file with the application satisfactory
 1807  proof that the clinic is in compliance with this part and
 1808  applicable rules, including:
 1809         (c) Proof of financial ability to operate as required under
 1810  ss. s. 408.810(8) and 408.8065. As an alternative to submitting
 1811  proof of financial ability to operate as required under s.
 1812  408.810(8), the applicant may file a surety bond of at least
 1813  $500,000 which guarantees that the clinic will act in full
 1814  conformity with all legal requirements for operating a clinic,
 1815  payable to the agency. The agency may adopt rules to specify
 1816  related requirements for such surety bond.
 1817         Section 51. Paragraph (g) of subsection (1) and paragraph
 1818  (a) of subsection (7) of section 400.9935, Florida Statutes, are
 1819  amended to read:
 1820         400.9935 Clinic responsibilities.—
 1821         (1) Each clinic shall appoint a medical director or clinic
 1822  director who shall agree in writing to accept legal
 1823  responsibility for the following activities on behalf of the
 1824  clinic. The medical director or the clinic director shall:
 1825         (g) Conduct systematic reviews of clinic billings to ensure
 1826  that the billings are not fraudulent or unlawful. Upon discovery
 1827  of an unlawful charge, the medical director or clinic director
 1828  shall take immediate corrective action. If the clinic performs
 1829  only the technical component of magnetic resonance imaging,
 1830  static radiographs, computed tomography, or positron emission
 1831  tomography, and provides the professional interpretation of such
 1832  services, in a fixed facility that is accredited by The Joint
 1833  Commission on Accreditation of Healthcare Organizations or the
 1834  Accreditation Association for Ambulatory Health Care, and the
 1835  American College of Radiology; and if, in the preceding quarter,
 1836  the percentage of scans performed by that clinic which was
 1837  billed to all personal injury protection insurance carriers was
 1838  less than 15 percent, the chief financial officer of the clinic
 1839  may, in a written acknowledgment provided to the agency, assume
 1840  the responsibility for the conduct of the systematic reviews of
 1841  clinic billings to ensure that the billings are not fraudulent
 1842  or unlawful.
 1843         (7)(a) Each clinic engaged in magnetic resonance imaging
 1844  services must be accredited by The Joint Commission on
 1845  Accreditation of Healthcare Organizations, the American College
 1846  of Radiology, or the Accreditation Association for Ambulatory
 1847  Health Care, within 1 year after licensure. A clinic that is
 1848  accredited by the American College of Radiology or is within the
 1849  original 1-year period after licensure and replaces its core
 1850  magnetic resonance imaging equipment shall be given 1 year after
 1851  the date on which the equipment is replaced to attain
 1852  accreditation. However, a clinic may request a single, 6-month
 1853  extension if it provides evidence to the agency establishing
 1854  that, for good cause shown, such clinic cannot be accredited
 1855  within 1 year after licensure, and that such accreditation will
 1856  be completed within the 6-month extension. After obtaining
 1857  accreditation as required by this subsection, each such clinic
 1858  must maintain accreditation as a condition of renewal of its
 1859  license. A clinic that files a change of ownership application
 1860  must comply with the original accreditation timeframe
 1861  requirements of the transferor. The agency shall deny a change
 1862  of ownership application if the clinic is not in compliance with
 1863  the accreditation requirements. When a clinic adds, replaces, or
 1864  modifies magnetic resonance imaging equipment and the
 1865  accreditation agency requires new accreditation, the clinic must
 1866  be accredited within 1 year after the date of the addition,
 1867  replacement, or modification but may request a single, 6-month
 1868  extension if the clinic provides evidence of good cause to the
 1869  agency.
 1870         Section 52. Subsection (2) of section 408.034, Florida
 1871  Statutes, is amended to read:
 1872         408.034 Duties and responsibilities of agency; rules.—
 1873         (2) In the exercise of its authority to issue licenses to
 1874  health care facilities and health service providers, as provided
 1875  under chapters 393 and 395 and parts II, and IV, and VIII of
 1876  chapter 400, the agency may not issue a license to any health
 1877  care facility or health service provider that fails to receive a
 1878  certificate of need or an exemption for the licensed facility or
 1879  service.
 1880         Section 53. Paragraph (d) of subsection (1) of section
 1881  408.036, Florida Statutes, is amended to read:
 1882         408.036 Projects subject to review; exemptions.—
 1883         (1) APPLICABILITY.—Unless exempt under subsection (3), all
 1884  health-care-related projects, as described in paragraphs (a)
 1885  (g), are subject to review and must file an application for a
 1886  certificate of need with the agency. The agency is exclusively
 1887  responsible for determining whether a health-care-related
 1888  project is subject to review under ss. 408.031-408.045.
 1889         (d) The establishment of a hospice or hospice inpatient
 1890  facility, except as provided in s. 408.043.
 1891         Section 54. Subsection (2) of section 408.043, Florida
 1892  Statutes, is amended to read:
 1893         408.043 Special provisions.—
 1894         (2) HOSPICES.—When an application is made for a certificate
 1895  of need to establish or to expand a hospice, the need for such
 1896  hospice shall be determined on the basis of the need for and
 1897  availability of hospice services in the community. The formula
 1898  on which the certificate of need is based shall discourage
 1899  regional monopolies and promote competition. The inpatient
 1900  hospice care component of a hospice which is a freestanding
 1901  facility, or a part of a facility, which is primarily engaged in
 1902  providing inpatient care and related services and is not
 1903  licensed as a health care facility shall also be required to
 1904  obtain a certificate of need. Provision of hospice care by any
 1905  current provider of health care is a significant change in
 1906  service and therefore requires a certificate of need for such
 1907  services.
 1908         Section 55. Paragraph (k) of subsection (3) of section
 1909  408.05, Florida Statutes, is amended to read:
 1910         408.05 Florida Center for Health Information and Policy
 1911  Analysis.—
 1912         (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to
 1913  produce comparable and uniform health information and statistics
 1914  for the development of policy recommendations, the agency shall
 1915  perform the following functions:
 1916         (k) Develop, in conjunction with the State Consumer Health
 1917  Information and Policy Advisory Council, and implement a long
 1918  range plan for making available health care quality measures and
 1919  financial data that will allow consumers to compare health care
 1920  services. The health care quality measures and financial data
 1921  the agency must make available shall include, but is not limited
 1922  to, pharmaceuticals, physicians, health care facilities, and
 1923  health plans and managed care entities. The agency shall submit
 1924  the initial plan to the Governor, the President of the Senate,
 1925  and the Speaker of the House of Representatives by January 1,
 1926  2006, and shall update the plan and report on the status of its
 1927  implementation annually thereafter. The agency shall also make
 1928  the plan and status report available to the public on its
 1929  Internet website. As part of the plan, the agency shall identify
 1930  the process and timeframes for implementation, any barriers to
 1931  implementation, and recommendations of changes in the law that
 1932  may be enacted by the Legislature to eliminate the barriers. As
 1933  preliminary elements of the plan, the agency shall:
 1934         1. Make available patient-safety indicators, inpatient
 1935  quality indicators, and performance outcome and patient charge
 1936  data collected from health care facilities pursuant to s.
 1937  408.061(1)(a) and (2). The terms “patient-safety indicators” and
 1938  “inpatient quality indicators” shall be as defined by the
 1939  Centers for Medicare and Medicaid Services, the National Quality
 1940  Forum, The Joint Commission on Accreditation of Healthcare
 1941  Organizations, the Agency for Healthcare Research and Quality,
 1942  the Centers for Disease Control and Prevention, or a similar
 1943  national entity that establishes standards to measure the
 1944  performance of health care providers, or by other states. The
 1945  agency shall determine which conditions, procedures, health care
 1946  quality measures, and patient charge data to disclose based upon
 1947  input from the council. When determining which conditions and
 1948  procedures are to be disclosed, the council and the agency shall
 1949  consider variation in costs, variation in outcomes, and
 1950  magnitude of variations and other relevant information. When
 1951  determining which health care quality measures to disclose, the
 1952  agency:
 1953         a. Shall consider such factors as volume of cases; average
 1954  patient charges; average length of stay; complication rates;
 1955  mortality rates; and infection rates, among others, which shall
 1956  be adjusted for case mix and severity, if applicable.
 1957         b. May consider such additional measures that are adopted
 1958  by the Centers for Medicare and Medicaid Studies, National
 1959  Quality Forum, The Joint Commission on Accreditation of
 1960  Healthcare Organizations, the Agency for Healthcare Research and
 1961  Quality, Centers for Disease Control and Prevention, or a
 1962  similar national entity that establishes standards to measure
 1963  the performance of health care providers, or by other states.
 1964  
 1965  When determining which patient charge data to disclose, the
 1966  agency shall include such measures as the average of
 1967  undiscounted charges on frequently performed procedures and
 1968  preventive diagnostic procedures, the range of procedure charges
 1969  from highest to lowest, average net revenue per adjusted patient
 1970  day, average cost per adjusted patient day, and average cost per
 1971  admission, among others.
 1972         2. Make available performance measures, benefit design, and
 1973  premium cost data from health plans licensed pursuant to chapter
 1974  627 or chapter 641. The agency shall determine which health care
 1975  quality measures and member and subscriber cost data to
 1976  disclose, based upon input from the council. When determining
 1977  which data to disclose, the agency shall consider information
 1978  that may be required by either individual or group purchasers to
 1979  assess the value of the product, which may include membership
 1980  satisfaction, quality of care, current enrollment or membership,
 1981  coverage areas, accreditation status, premium costs, plan costs,
 1982  premium increases, range of benefits, copayments and
 1983  deductibles, accuracy and speed of claims payment, credentials
 1984  of physicians, number of providers, names of network providers,
 1985  and hospitals in the network. Health plans shall make available
 1986  to the agency any such data or information that is not currently
 1987  reported to the agency or the office.
 1988         3. Determine the method and format for public disclosure of
 1989  data reported pursuant to this paragraph. The agency shall make
 1990  its determination based upon input from the State Consumer
 1991  Health Information and Policy Advisory Council. At a minimum,
 1992  the data shall be made available on the agency’s Internet
 1993  website in a manner that allows consumers to conduct an
 1994  interactive search that allows them to view and compare the
 1995  information for specific providers. The website must include
 1996  such additional information as is determined necessary to ensure
 1997  that the website enhances informed decisionmaking among
 1998  consumers and health care purchasers, which shall include, at a
 1999  minimum, appropriate guidance on how to use the data and an
 2000  explanation of why the data may vary from provider to provider.
 2001  The data specified in subparagraph 1. shall be released no later
 2002  than January 1, 2006, for the reporting of infection rates, and
 2003  no later than October 1, 2005, for mortality rates and
 2004  complication rates. The data specified in subparagraph 2. shall
 2005  be released no later than October 1, 2006.
 2006         4. Publish on its website undiscounted charges for no fewer
 2007  than 150 of the most commonly performed adult and pediatric
 2008  procedures, including outpatient, inpatient, diagnostic, and
 2009  preventative procedures.
 2010         Section 56. Paragraph (a) of subsection (1) of section
 2011  408.061, Florida Statutes, is amended to read:
 2012         408.061 Data collection; uniform systems of financial
 2013  reporting; information relating to physician charges;
 2014  confidential information; immunity.—
 2015         (1) The agency shall require the submission by health care
 2016  facilities, health care providers, and health insurers of data
 2017  necessary to carry out the agency’s duties. Specifications for
 2018  data to be collected under this section shall be developed by
 2019  the agency with the assistance of technical advisory panels
 2020  including representatives of affected entities, consumers,
 2021  purchasers, and such other interested parties as may be
 2022  determined by the agency.
 2023         (a) Data submitted by health care facilities, including the
 2024  facilities as defined in chapter 395, shall include, but are not
 2025  limited to: case-mix data, patient admission and discharge data,
 2026  hospital emergency department data which shall include the
 2027  number of patients treated in the emergency department of a
 2028  licensed hospital reported by patient acuity level, data on
 2029  hospital-acquired infections as specified by rule, data on
 2030  complications as specified by rule, data on readmissions as
 2031  specified by rule, with patient and provider-specific
 2032  identifiers included, actual charge data by diagnostic groups,
 2033  financial data, accounting data, operating expenses, expenses
 2034  incurred for rendering services to patients who cannot or do not
 2035  pay, interest charges, depreciation expenses based on the
 2036  expected useful life of the property and equipment involved, and
 2037  demographic data. The agency shall adopt nationally recognized
 2038  risk adjustment methodologies or software consistent with the
 2039  standards of the Agency for Healthcare Research and Quality and
 2040  as selected by the agency for all data submitted as required by
 2041  this section. Data may be obtained from documents such as, but
 2042  not limited to: leases, contracts, debt instruments, itemized
 2043  patient bills, medical record abstracts, and related diagnostic
 2044  information. Reported data elements shall be reported
 2045  electronically and in accordance with rule 59E-7.012, Florida
 2046  Administrative Code. Data submitted shall be certified by the
 2047  chief executive officer or an appropriate and duly authorized
 2048  representative or employee of the licensed facility that the
 2049  information submitted is true and accurate.
 2050         Section 57. Subsection (43) of section 408.07, Florida
 2051  Statutes, is amended to read:
 2052         408.07 Definitions.—As used in this chapter, with the
 2053  exception of ss. 408.031-408.045, the term:
 2054         (43) “Rural hospital” means an acute care hospital licensed
 2055  under chapter 395, having 100 or fewer licensed beds and an
 2056  emergency room, and which is:
 2057         (a) The sole provider within a county with a population
 2058  density of no greater than 100 persons per square mile;
 2059         (b) An acute care hospital, in a county with a population
 2060  density of no greater than 100 persons per square mile, which is
 2061  at least 30 minutes of travel time, on normally traveled roads
 2062  under normal traffic conditions, from another acute care
 2063  hospital within the same county;
 2064         (c) A hospital supported by a tax district or subdistrict
 2065  whose boundaries encompass a population of 100 persons or fewer
 2066  per square mile;
 2067         (d) A hospital with a service area that has a population of
 2068  100 persons or fewer per square mile. As used in this paragraph,
 2069  the term “service area” means the fewest number of zip codes
 2070  that account for 75 percent of the hospital’s discharges for the
 2071  most recent 5-year period, based on information available from
 2072  the hospital inpatient discharge database in the Florida Center
 2073  for Health Information and Policy Analysis at the Agency for
 2074  Health Care Administration; or
 2075         (e) A critical access hospital.
 2076  
 2077  Population densities used in this subsection must be based upon
 2078  the most recently completed United States census. A hospital
 2079  that received funds under s. 409.9116 for a quarter beginning no
 2080  later than July 1, 2002, is deemed to have been and shall
 2081  continue to be a rural hospital from that date through June 30,
 2082  2015, if the hospital continues to have 100 or fewer licensed
 2083  beds and an emergency room, or meets the criteria of s.
 2084  395.602(2)(e)4. An acute care hospital that has not previously
 2085  been designated as a rural hospital and that meets the criteria
 2086  of this subsection shall be granted such designation upon
 2087  application, including supporting documentation, to the Agency
 2088  for Health Care Administration.
 2089         Section 58. Section 408.10, Florida Statutes, is amended to
 2090  read:
 2091         408.10 Consumer complaints.—The agency shall:
 2092         (1) publish and make available to the public a toll-free
 2093  telephone number for the purpose of handling consumer complaints
 2094  and shall serve as a liaison between consumer entities and other
 2095  private entities and governmental entities for the disposition
 2096  of problems identified by consumers of health care.
 2097         (2)Be empowered to investigate consumer complaints
 2098  relating to problems with health care facilities’ billing
 2099  practices and issue reports to be made public in any cases where
 2100  the agency determines the health care facility has engaged in
 2101  billing practices which are unreasonable and unfair to the
 2102  consumer.
 2103         Section 59. Subsections (12) through (30) of section
 2104  408.802, Florida Statutes, are renumbered as subsections (11)
 2105  through (29), respectively, and present subsection (11) of that
 2106  section is amended to read:
 2107         408.802 Applicability.—The provisions of this part apply to
 2108  the provision of services that require licensure as defined in
 2109  this part and to the following entities licensed, registered, or
 2110  certified by the agency, as described in chapters 112, 383, 390,
 2111  394, 395, 400, 429, 440, 483, and 765:
 2112         (11)Private review agents, as provided under part I of
 2113  chapter 395.
 2114         Section 60. Subsection (3) is added to section 408.804,
 2115  Florida Statutes, to read:
 2116         408.804 License required; display.—
 2117         (3)Any person who knowingly alters, defaces, or falsifies
 2118  a license certificate issued by the agency, or causes or
 2119  procures any person to commit such an offense, commits a
 2120  misdemeanor of the second degree, punishable as provided in s.
 2121  775.082 or s 775.083. Any licensee or provider who displays an
 2122  altered, defaced, or falsified license certificate is subject to
 2123  the penalties set forth in s. 408.815 and an administrative fine
 2124  of $1,000 for each day of illegal display.
 2125         Section 61. Paragraph (d) of subsection (2) of section
 2126  408.806, Florida Statutes, is amended, present subsections (3)
 2127  through (8) are renumbered as subsections (4) through (9),
 2128  respectively, and a new subsection (3) is added to that section,
 2129  to read:
 2130         408.806 License application process.—
 2131         (2)
 2132         (d) The agency shall notify the licensee by mail or
 2133  electronically at least 90 days before the expiration of a
 2134  license that a renewal license is necessary to continue
 2135  operation. The licensee’s failure to timely file submit a
 2136  renewal application and license application fee with the agency
 2137  shall result in a $50 per day late fee charged to the licensee
 2138  by the agency; however, the aggregate amount of the late fee may
 2139  not exceed 50 percent of the licensure fee or $500, whichever is
 2140  less. The agency shall provide a courtesy notice to the licensee
 2141  by United States mail, electronically, or by any other manner at
 2142  its address of record or mailing address, if provided, at least
 2143  90 days prior to the expiration of a license informing the
 2144  licensee of the expiration of the license. If the agency does
 2145  not provide the courtesy notice or the licensee does not receive
 2146  the courtesy notice, the licensee continues to be legally
 2147  obligated to timely file the renewal application and license
 2148  application fee with the agency and is not excused from the
 2149  payment of a late fee. If an application is received after the
 2150  required filing date and exhibits a hand-canceled postmark
 2151  obtained from a United States post office dated on or before the
 2152  required filing date, no fine will be levied.
 2153         (3)Payment of the late fee is required to consider any
 2154  late application complete, and failure to pay the late fee is
 2155  considered an omission from the application.
 2156         Section 62. Subsections (6) and (9) of section 408.810,
 2157  Florida Statutes, are amended to read:
 2158         408.810 Minimum licensure requirements.—In addition to the
 2159  licensure requirements specified in this part, authorizing
 2160  statutes, and applicable rules, each applicant and licensee must
 2161  comply with the requirements of this section in order to obtain
 2162  and maintain a license.
 2163         (6)(a) An applicant must provide the agency with proof of
 2164  the applicant’s legal right to occupy the property before a
 2165  license may be issued. Proof may include, but need not be
 2166  limited to, copies of warranty deeds, lease or rental
 2167  agreements, contracts for deeds, quitclaim deeds, or other such
 2168  documentation.
 2169         (b)In the event the property is encumbered by a mortgage
 2170  or is leased, an applicant must provide the agency with proof
 2171  that the mortgagor or landlord has been provided written notice
 2172  of the applicant’s intent as mortgagee or tenant to provide
 2173  services that require licensure and instruct the mortgagor or
 2174  landlord to serve the agency by certified mail with copies of
 2175  any foreclosure or eviction actions initiated by the mortgagor
 2176  or landlord against the applicant.
 2177         (9) A controlling interest may not withhold from the agency
 2178  any evidence of financial instability, including, but not
 2179  limited to, checks returned due to insufficient funds,
 2180  delinquent accounts, nonpayment of withholding taxes, unpaid
 2181  utility expenses, nonpayment for essential services, or adverse
 2182  court action concerning the financial viability of the provider
 2183  or any other provider licensed under this part that is under the
 2184  control of the controlling interest. A controlling interest
 2185  shall notify the agency within 10 days after a court action to
 2186  initiate bankruptcy, foreclosure, or eviction proceedings
 2187  concerning the provider, in which the controlling interest is a
 2188  petitioner or defendant. Any person who violates this subsection
 2189  commits a misdemeanor of the second degree, punishable as
 2190  provided in s. 775.082 or s. 775.083. Each day of continuing
 2191  violation is a separate offense.
 2192         Section 63. Subsection (3) is added to section 408.813,
 2193  Florida Statutes, to read:
 2194         408.813 Administrative fines; violations.—As a penalty for
 2195  any violation of this part, authorizing statutes, or applicable
 2196  rules, the agency may impose an administrative fine.
 2197         (3)The agency may impose an administrative fine for a
 2198  violation that does not qualify as a class I, class II, class
 2199  III, or class IV violation. Unless otherwise specified by law,
 2200  the amount of the fine shall not exceed $500 for each violation.
 2201  Unclassified violations may include:
 2202         (a)Violating any term or condition of a license.
 2203         (b)Violating any provision of this part, authorizing
 2204  statutes, or applicable rules.
 2205         (c)Exceeding licensed capacity.
 2206         (d)Providing services beyond the scope of the license.
 2207         (e)Violating a moratorium imposed pursuant to s. 408.814.
 2208         Section 64. Subsection (5) is added to section 408.815,
 2209  Florida Statutes, to read:
 2210         408.815 License or application denial; revocation.—
 2211         (5)In order to ensure the health, safety, and welfare of
 2212  clients when a license has been denied, revoked, or is set to
 2213  terminate, the agency may extend the license expiration date for
 2214  a period of up to 30 days for the sole purpose of allowing the
 2215  safe and orderly discharge of clients. The agency may impose
 2216  conditions on the extension, including, but not limited to,
 2217  prohibiting or limiting admissions, expedited discharge
 2218  planning, required status reports, and mandatory monitoring by
 2219  the agency or third parties. In imposing these conditions, the
 2220  agency shall take into consideration the nature and number of
 2221  clients, the availability and location of acceptable alternative
 2222  placements, and the ability of the licensee to continue
 2223  providing care to the clients. The agency may terminate the
 2224  extension or modify the conditions at any time. This authority
 2225  is in addition to any other authority granted to the agency
 2226  under chapter 120, this part, and authorizing statutes but
 2227  creates no right or entitlement to an extension of a license
 2228  expiration date.
 2229         Section 65. Paragraph (k) of subsection (4) of section
 2230  409.221, Florida Statutes, is amended to read:
 2231         409.221 Consumer-directed care program.—
 2232         (4) CONSUMER-DIRECTED CARE.—
 2233         (k)Reviews and reports.The agency and the Departments of
 2234  Elderly Affairs, Health, and Children and Family Services and
 2235  the Agency for Persons with Disabilities shall each, on an
 2236  ongoing basis, review and assess the implementation of the
 2237  consumer-directed care program. By January 15 of each year, the
 2238  agency shall submit a written report to the Legislature that
 2239  includes each department’s review of the program and contains
 2240  recommendations for improvements to the program.
 2241         Section 66. Subsection (1) of section 409.91196, Florida
 2242  Statutes, is amended to read:
 2243         409.91196 Supplemental rebate agreements; public records
 2244  and public meetings exemption.—
 2245         (1) The rebate amount, percent of rebate, manufacturer’s
 2246  pricing, and supplemental rebate, and other trade secrets as
 2247  defined in s. 688.002 that the agency has identified for use in
 2248  negotiations, held by the Agency for Health Care Administration
 2249  under s. 409.912(39)(a)8.7. are confidential and exempt from s.
 2250  119.07(1) and s. 24(a), Art. I of the State Constitution.
 2251         Section 67. Paragraph (a) of subsection (39) of section
 2252  409.912, Florida Statutes, is amended to read:
 2253         409.912 Cost-effective purchasing of health care.—The
 2254  agency shall purchase goods and services for Medicaid recipients
 2255  in the most cost-effective manner consistent with the delivery
 2256  of quality medical care. To ensure that medical services are
 2257  effectively utilized, the agency may, in any case, require a
 2258  confirmation or second physician’s opinion of the correct
 2259  diagnosis for purposes of authorizing future services under the
 2260  Medicaid program. This section does not restrict access to
 2261  emergency services or poststabilization care services as defined
 2262  in 42 C.F.R. part 438.114. Such confirmation or second opinion
 2263  shall be rendered in a manner approved by the agency. The agency
 2264  shall maximize the use of prepaid per capita and prepaid
 2265  aggregate fixed-sum basis services when appropriate and other
 2266  alternative service delivery and reimbursement methodologies,
 2267  including competitive bidding pursuant to s. 287.057, designed
 2268  to facilitate the cost-effective purchase of a case-managed
 2269  continuum of care. The agency shall also require providers to
 2270  minimize the exposure of recipients to the need for acute
 2271  inpatient, custodial, and other institutional care and the
 2272  inappropriate or unnecessary use of high-cost services. The
 2273  agency shall contract with a vendor to monitor and evaluate the
 2274  clinical practice patterns of providers in order to identify
 2275  trends that are outside the normal practice patterns of a
 2276  provider’s professional peers or the national guidelines of a
 2277  provider’s professional association. The vendor must be able to
 2278  provide information and counseling to a provider whose practice
 2279  patterns are outside the norms, in consultation with the agency,
 2280  to improve patient care and reduce inappropriate utilization.
 2281  The agency may mandate prior authorization, drug therapy
 2282  management, or disease management participation for certain
 2283  populations of Medicaid beneficiaries, certain drug classes, or
 2284  particular drugs to prevent fraud, abuse, overuse, and possible
 2285  dangerous drug interactions. The Pharmaceutical and Therapeutics
 2286  Committee shall make recommendations to the agency on drugs for
 2287  which prior authorization is required. The agency shall inform
 2288  the Pharmaceutical and Therapeutics Committee of its decisions
 2289  regarding drugs subject to prior authorization. The agency is
 2290  authorized to limit the entities it contracts with or enrolls as
 2291  Medicaid providers by developing a provider network through
 2292  provider credentialing. The agency may competitively bid single
 2293  source-provider contracts if procurement of goods or services
 2294  results in demonstrated cost savings to the state without
 2295  limiting access to care. The agency may limit its network based
 2296  on the assessment of beneficiary access to care, provider
 2297  availability, provider quality standards, time and distance
 2298  standards for access to care, the cultural competence of the
 2299  provider network, demographic characteristics of Medicaid
 2300  beneficiaries, practice and provider-to-beneficiary standards,
 2301  appointment wait times, beneficiary use of services, provider
 2302  turnover, provider profiling, provider licensure history,
 2303  previous program integrity investigations and findings, peer
 2304  review, provider Medicaid policy and billing compliance records,
 2305  clinical and medical record audits, and other factors. Providers
 2306  shall not be entitled to enrollment in the Medicaid provider
 2307  network. The agency shall determine instances in which allowing
 2308  Medicaid beneficiaries to purchase durable medical equipment and
 2309  other goods is less expensive to the Medicaid program than long
 2310  term rental of the equipment or goods. The agency may establish
 2311  rules to facilitate purchases in lieu of long-term rentals in
 2312  order to protect against fraud and abuse in the Medicaid program
 2313  as defined in s. 409.913. The agency may seek federal waivers
 2314  necessary to administer these policies.
 2315         (39)(a) The agency shall implement a Medicaid prescribed
 2316  drug spending-control program that includes the following
 2317  components:
 2318         1. A Medicaid preferred drug list, which shall be a listing
 2319  of cost-effective therapeutic options recommended by the
 2320  Medicaid Pharmacy and Therapeutics Committee established
 2321  pursuant to s. 409.91195 and adopted by the agency for each
 2322  therapeutic class on the preferred drug list. At the discretion
 2323  of the committee, and when feasible, the preferred drug list
 2324  should include at least two products in a therapeutic class. The
 2325  agency may post the preferred drug list and updates to the
 2326  preferred drug list on an Internet website without following the
 2327  rulemaking procedures of chapter 120. Antiretroviral agents are
 2328  excluded from the preferred drug list. The agency shall also
 2329  limit the amount of a prescribed drug dispensed to no more than
 2330  a 34-day supply unless the drug products’ smallest marketed
 2331  package is greater than a 34-day supply, or the drug is
 2332  determined by the agency to be a maintenance drug in which case
 2333  a 100-day maximum supply may be authorized. The agency is
 2334  authorized to seek any federal waivers necessary to implement
 2335  these cost-control programs and to continue participation in the
 2336  federal Medicaid rebate program, or alternatively to negotiate
 2337  state-only manufacturer rebates. The agency may adopt rules to
 2338  implement this subparagraph. The agency shall continue to
 2339  provide unlimited contraceptive drugs and items. The agency must
 2340  establish procedures to ensure that:
 2341         a. There is a response to a request for prior consultation
 2342  by telephone or other telecommunication device within 24 hours
 2343  after receipt of a request for prior consultation; and
 2344         b. A 72-hour supply of the drug prescribed is provided in
 2345  an emergency or when the agency does not provide a response
 2346  within 24 hours as required by sub-subparagraph a.
 2347         2. Reimbursement to pharmacies for Medicaid prescribed
 2348  drugs shall be set at the lesser of: the average wholesale price
 2349  (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
 2350  plus 4.75 percent, the federal upper limit (FUL), the state
 2351  maximum allowable cost (SMAC), or the usual and customary (UAC)
 2352  charge billed by the provider.
 2353         3.For a prescribed drug billed as a 340B prescribed
 2354  medication, the claim must meet the requirements of the Deficit
 2355  Reduction Act of 2005 and the federal 340B program, contain a
 2356  national drug code, and be billed at the actual acquisition cost
 2357  or payment shall be denied.
 2358         4.3. The agency shall develop and implement a process for
 2359  managing the drug therapies of Medicaid recipients who are using
 2360  significant numbers of prescribed drugs each month. The
 2361  management process may include, but is not limited to,
 2362  comprehensive, physician-directed medical-record reviews, claims
 2363  analyses, and case evaluations to determine the medical
 2364  necessity and appropriateness of a patient’s treatment plan and
 2365  drug therapies. The agency may contract with a private
 2366  organization to provide drug-program-management services. The
 2367  Medicaid drug benefit management program shall include
 2368  initiatives to manage drug therapies for HIV/AIDS patients,
 2369  patients using 20 or more unique prescriptions in a 180-day
 2370  period, and the top 1,000 patients in annual spending. The
 2371  agency shall enroll any Medicaid recipient in the drug benefit
 2372  management program if he or she meets the specifications of this
 2373  provision and is not enrolled in a Medicaid health maintenance
 2374  organization.
 2375         5.4. The agency may limit the size of its pharmacy network
 2376  based on need, competitive bidding, price negotiations,
 2377  credentialing, or similar criteria. The agency shall give
 2378  special consideration to rural areas in determining the size and
 2379  location of pharmacies included in the Medicaid pharmacy
 2380  network. A pharmacy credentialing process may include criteria
 2381  such as a pharmacy’s full-service status, location, size,
 2382  patient educational programs, patient consultation, disease
 2383  management services, and other characteristics. The agency may
 2384  impose a moratorium on Medicaid pharmacy enrollment when it is
 2385  determined that it has a sufficient number of Medicaid
 2386  participating providers. The agency must allow dispensing
 2387  practitioners to participate as a part of the Medicaid pharmacy
 2388  network regardless of the practitioner’s proximity to any other
 2389  entity that is dispensing prescription drugs under the Medicaid
 2390  program. A dispensing practitioner must meet all credentialing
 2391  requirements applicable to his or her practice, as determined by
 2392  the agency.
 2393         6.5. The agency shall develop and implement a program that
 2394  requires Medicaid practitioners who prescribe drugs to use a
 2395  counterfeit-proof prescription pad for Medicaid prescriptions.
 2396  The agency shall require the use of standardized counterfeit
 2397  proof prescription pads by Medicaid-participating prescribers or
 2398  prescribers who write prescriptions for Medicaid recipients. The
 2399  agency may implement the program in targeted geographic areas or
 2400  statewide.
 2401         7.6. The agency may enter into arrangements that require
 2402  manufacturers of generic drugs prescribed to Medicaid recipients
 2403  to provide rebates of at least 15.1 percent of the average
 2404  manufacturer price for the manufacturer’s generic products.
 2405  These arrangements shall require that if a generic-drug
 2406  manufacturer pays federal rebates for Medicaid-reimbursed drugs
 2407  at a level below 15.1 percent, the manufacturer must provide a
 2408  supplemental rebate to the state in an amount necessary to
 2409  achieve a 15.1-percent rebate level.
 2410         8.7. The agency may establish a preferred drug list as
 2411  described in this subsection, and, pursuant to the establishment
 2412  of such preferred drug list, it is authorized to negotiate
 2413  supplemental rebates from manufacturers that are in addition to
 2414  those required by Title XIX of the Social Security Act and at no
 2415  less than 14 percent of the average manufacturer price as
 2416  defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
 2417  the federal or supplemental rebate, or both, equals or exceeds
 2418  29 percent. There is no upper limit on the supplemental rebates
 2419  the agency may negotiate. The agency may determine that specific
 2420  products, brand-name or generic, are competitive at lower rebate
 2421  percentages. Agreement to pay the minimum supplemental rebate
 2422  percentage will guarantee a manufacturer that the Medicaid
 2423  Pharmaceutical and Therapeutics Committee will consider a
 2424  product for inclusion on the preferred drug list. However, a
 2425  pharmaceutical manufacturer is not guaranteed placement on the
 2426  preferred drug list by simply paying the minimum supplemental
 2427  rebate. Agency decisions will be made on the clinical efficacy
 2428  of a drug and recommendations of the Medicaid Pharmaceutical and
 2429  Therapeutics Committee, as well as the price of competing
 2430  products minus federal and state rebates. The agency is
 2431  authorized to contract with an outside agency or contractor to
 2432  conduct negotiations for supplemental rebates. For the purposes
 2433  of this section, the term “supplemental rebates” means cash
 2434  rebates. Effective July 1, 2004, value-added programs as a
 2435  substitution for supplemental rebates are prohibited. The agency
 2436  is authorized to seek any federal waivers to implement this
 2437  initiative.
 2438         9.8. The Agency for Health Care Administration shall expand
 2439  home delivery of pharmacy products. To assist Medicaid patients
 2440  in securing their prescriptions and reduce program costs, the
 2441  agency shall expand its current mail-order-pharmacy diabetes
 2442  supply program to include all generic and brand-name drugs used
 2443  by Medicaid patients with diabetes. Medicaid recipients in the
 2444  current program may obtain nondiabetes drugs on a voluntary
 2445  basis. This initiative is limited to the geographic area covered
 2446  by the current contract. The agency may seek and implement any
 2447  federal waivers necessary to implement this subparagraph.
 2448         10.9. The agency shall limit to one dose per month any drug
 2449  prescribed to treat erectile dysfunction.
 2450         11.10.a. The agency may implement a Medicaid behavioral
 2451  drug management system. The agency may contract with a vendor
 2452  that has experience in operating behavioral drug management
 2453  systems to implement this program. The agency is authorized to
 2454  seek federal waivers to implement this program.
 2455         b. The agency, in conjunction with the Department of
 2456  Children and Family Services, may implement the Medicaid
 2457  behavioral drug management system that is designed to improve
 2458  the quality of care and behavioral health prescribing practices
 2459  based on best practice guidelines, improve patient adherence to
 2460  medication plans, reduce clinical risk, and lower prescribed
 2461  drug costs and the rate of inappropriate spending on Medicaid
 2462  behavioral drugs. The program may include the following
 2463  elements:
 2464         (I) Provide for the development and adoption of best
 2465  practice guidelines for behavioral health-related drugs such as
 2466  antipsychotics, antidepressants, and medications for treating
 2467  bipolar disorders and other behavioral conditions; translate
 2468  them into practice; review behavioral health prescribers and
 2469  compare their prescribing patterns to a number of indicators
 2470  that are based on national standards; and determine deviations
 2471  from best practice guidelines.
 2472         (II) Implement processes for providing feedback to and
 2473  educating prescribers using best practice educational materials
 2474  and peer-to-peer consultation.
 2475         (III) Assess Medicaid beneficiaries who are outliers in
 2476  their use of behavioral health drugs with regard to the numbers
 2477  and types of drugs taken, drug dosages, combination drug
 2478  therapies, and other indicators of improper use of behavioral
 2479  health drugs.
 2480         (IV) Alert prescribers to patients who fail to refill
 2481  prescriptions in a timely fashion, are prescribed multiple same
 2482  class behavioral health drugs, and may have other potential
 2483  medication problems.
 2484         (V) Track spending trends for behavioral health drugs and
 2485  deviation from best practice guidelines.
 2486         (VI) Use educational and technological approaches to
 2487  promote best practices, educate consumers, and train prescribers
 2488  in the use of practice guidelines.
 2489         (VII) Disseminate electronic and published materials.
 2490         (VIII) Hold statewide and regional conferences.
 2491         (IX) Implement a disease management program with a model
 2492  quality-based medication component for severely mentally ill
 2493  individuals and emotionally disturbed children who are high
 2494  users of care.
 2495         12.11.a. The agency shall implement a Medicaid prescription
 2496  drug management system. The agency may contract with a vendor
 2497  that has experience in operating prescription drug management
 2498  systems in order to implement this system. Any management system
 2499  that is implemented in accordance with this subparagraph must
 2500  rely on cooperation between physicians and pharmacists to
 2501  determine appropriate practice patterns and clinical guidelines
 2502  to improve the prescribing, dispensing, and use of drugs in the
 2503  Medicaid program. The agency may seek federal waivers to
 2504  implement this program.
 2505         b. The drug management system must be designed to improve
 2506  the quality of care and prescribing practices based on best
 2507  practice guidelines, improve patient adherence to medication
 2508  plans, reduce clinical risk, and lower prescribed drug costs and
 2509  the rate of inappropriate spending on Medicaid prescription
 2510  drugs. The program must:
 2511         (I) Provide for the development and adoption of best
 2512  practice guidelines for the prescribing and use of drugs in the
 2513  Medicaid program, including translating best practice guidelines
 2514  into practice; reviewing prescriber patterns and comparing them
 2515  to indicators that are based on national standards and practice
 2516  patterns of clinical peers in their community, statewide, and
 2517  nationally; and determine deviations from best practice
 2518  guidelines.
 2519         (II) Implement processes for providing feedback to and
 2520  educating prescribers using best practice educational materials
 2521  and peer-to-peer consultation.
 2522         (III) Assess Medicaid recipients who are outliers in their
 2523  use of a single or multiple prescription drugs with regard to
 2524  the numbers and types of drugs taken, drug dosages, combination
 2525  drug therapies, and other indicators of improper use of
 2526  prescription drugs.
 2527         (IV) Alert prescribers to patients who fail to refill
 2528  prescriptions in a timely fashion, are prescribed multiple drugs
 2529  that may be redundant or contraindicated, or may have other
 2530  potential medication problems.
 2531         (V) Track spending trends for prescription drugs and
 2532  deviation from best practice guidelines.
 2533         (VI) Use educational and technological approaches to
 2534  promote best practices, educate consumers, and train prescribers
 2535  in the use of practice guidelines.
 2536         (VII) Disseminate electronic and published materials.
 2537         (VIII) Hold statewide and regional conferences.
 2538         (IX) Implement disease management programs in cooperation
 2539  with physicians and pharmacists, along with a model quality
 2540  based medication component for individuals having chronic
 2541  medical conditions.
 2542         13.12. The agency is authorized to contract for drug rebate
 2543  administration, including, but not limited to, calculating
 2544  rebate amounts, invoicing manufacturers, negotiating disputes
 2545  with manufacturers, and maintaining a database of rebate
 2546  collections.
 2547         14.13. The agency may specify the preferred daily dosing
 2548  form or strength for the purpose of promoting best practices
 2549  with regard to the prescribing of certain drugs as specified in
 2550  the General Appropriations Act and ensuring cost-effective
 2551  prescribing practices.
 2552         15.14. The agency may require prior authorization for
 2553  Medicaid-covered prescribed drugs. The agency may, but is not
 2554  required to, prior-authorize the use of a product:
 2555         a. For an indication not approved in labeling;
 2556         b. To comply with certain clinical guidelines; or
 2557         c. If the product has the potential for overuse, misuse, or
 2558  abuse.
 2559  
 2560  The agency may require the prescribing professional to provide
 2561  information about the rationale and supporting medical evidence
 2562  for the use of a drug. The agency may post prior authorization
 2563  criteria and protocol and updates to the list of drugs that are
 2564  subject to prior authorization on an Internet website without
 2565  amending its rule or engaging in additional rulemaking.
 2566         16.15. The agency, in conjunction with the Pharmaceutical
 2567  and Therapeutics Committee, may require age-related prior
 2568  authorizations for certain prescribed drugs. The agency may
 2569  preauthorize the use of a drug for a recipient who may not meet
 2570  the age requirement or may exceed the length of therapy for use
 2571  of this product as recommended by the manufacturer and approved
 2572  by the Food and Drug Administration. Prior authorization may
 2573  require the prescribing professional to provide information
 2574  about the rationale and supporting medical evidence for the use
 2575  of a drug.
 2576         17.16. The agency shall implement a step-therapy prior
 2577  authorization approval process for medications excluded from the
 2578  preferred drug list. Medications listed on the preferred drug
 2579  list must be used within the previous 12 months prior to the
 2580  alternative medications that are not listed. The step-therapy
 2581  prior authorization may require the prescriber to use the
 2582  medications of a similar drug class or for a similar medical
 2583  indication unless contraindicated in the Food and Drug
 2584  Administration labeling. The trial period between the specified
 2585  steps may vary according to the medical indication. The step
 2586  therapy approval process shall be developed in accordance with
 2587  the committee as stated in s. 409.91195(7) and (8). A drug
 2588  product may be approved without meeting the step-therapy prior
 2589  authorization criteria if the prescribing physician provides the
 2590  agency with additional written medical or clinical documentation
 2591  that the product is medically necessary because:
 2592         a. There is not a drug on the preferred drug list to treat
 2593  the disease or medical condition which is an acceptable clinical
 2594  alternative;
 2595         b. The alternatives have been ineffective in the treatment
 2596  of the beneficiary’s disease; or
 2597         c. Based on historic evidence and known characteristics of
 2598  the patient and the drug, the drug is likely to be ineffective,
 2599  or the number of doses have been ineffective.
 2600  
 2601  The agency shall work with the physician to determine the best
 2602  alternative for the patient. The agency may adopt rules waiving
 2603  the requirements for written clinical documentation for specific
 2604  drugs in limited clinical situations.
 2605         18.17. The agency shall implement a return and reuse
 2606  program for drugs dispensed by pharmacies to institutional
 2607  recipients, which includes payment of a $5 restocking fee for
 2608  the implementation and operation of the program. The return and
 2609  reuse program shall be implemented electronically and in a
 2610  manner that promotes efficiency. The program must permit a
 2611  pharmacy to exclude drugs from the program if it is not
 2612  practical or cost-effective for the drug to be included and must
 2613  provide for the return to inventory of drugs that cannot be
 2614  credited or returned in a cost-effective manner. The agency
 2615  shall determine if the program has reduced the amount of
 2616  Medicaid prescription drugs which are destroyed on an annual
 2617  basis and if there are additional ways to ensure more
 2618  prescription drugs are not destroyed which could safely be
 2619  reused. The agency’s conclusion and recommendations shall be
 2620  reported to the Legislature by December 1, 2005.
 2621         Section 68. Subsections (3) and (4) of section 429.07,
 2622  Florida Statutes, are amended, and subsections (6) and (7) are
 2623  added to that section, to read:
 2624         429.07 License required; fee; inspections.—
 2625         (3) In addition to the requirements of s. 408.806, each
 2626  license granted by the agency must state the type of care for
 2627  which the license is granted. Licenses shall be issued for one
 2628  or more of the following categories of care: standard, extended
 2629  congregate care, limited nursing services, or limited mental
 2630  health.
 2631         (a) A standard license shall be issued to a facility
 2632  facilities providing one or more of the personal services
 2633  identified in s. 429.02. Such licensee facilities may also
 2634  employ or contract with a person licensed under part I of
 2635  chapter 464 to administer medications and perform other tasks as
 2636  specified in s. 429.255.
 2637         (b) An extended congregate care license shall be issued to
 2638  a licensee facilities providing, directly or through contract,
 2639  services beyond those authorized in paragraph (a), including
 2640  acts performed pursuant to part I of chapter 464 by persons
 2641  licensed thereunder, and supportive services defined by rule to
 2642  persons who otherwise would be disqualified from continued
 2643  residence in a facility licensed under this part.
 2644         1. In order for extended congregate care services to be
 2645  provided in a facility licensed under this part, the agency must
 2646  first determine that all requirements established in law and
 2647  rule are met and must specifically designate, on the facility’s
 2648  license, that such services may be provided and whether the
 2649  designation applies to all or part of a facility. Such
 2650  designation may be made at the time of initial licensure or
 2651  relicensure, or upon request in writing by a licensee under this
 2652  part and part II of chapter 408. Notification of approval or
 2653  denial of such request shall be made in accordance with part II
 2654  of chapter 408. An existing licensee facilities qualifying to
 2655  provide extended congregate care services must have maintained a
 2656  standard license and may not have been subject to administrative
 2657  sanctions during the previous 2 years, or since initial
 2658  licensure if the facility has been licensed for less than 2
 2659  years, for any of the following reasons:
 2660         a. A class I or class II violation;
 2661         b. Three or more repeat or recurring class III violations
 2662  of identical or similar resident care standards as specified in
 2663  rule from which a pattern of noncompliance is found by the
 2664  agency;
 2665         c. Three or more class III violations that were not
 2666  corrected in accordance with the corrective action plan approved
 2667  by the agency;
 2668         d. Violation of resident care standards resulting in a
 2669  requirement to employ the services of a consultant pharmacist or
 2670  consultant dietitian;
 2671         e. Denial, suspension, or revocation of a license for
 2672  another facility under this part in which the applicant for an
 2673  extended congregate care license has at least 25 percent
 2674  ownership interest; or
 2675         f. Imposition of a moratorium pursuant to this part or part
 2676  II of chapter 408 or initiation of injunctive proceedings.
 2677         2. A licensee Facilities that is are licensed to provide
 2678  extended congregate care services shall maintain a written
 2679  progress report for on each person who receives such services,
 2680  and the which report must describe describes the type, amount,
 2681  duration, scope, and outcome of services that are rendered and
 2682  the general status of the resident’s health. A registered nurse,
 2683  or appropriate designee, representing the agency shall visit
 2684  such facilities at least quarterly to monitor residents who are
 2685  receiving extended congregate care services and to determine if
 2686  the facility is in compliance with this part, part II of chapter
 2687  408, and rules that relate to extended congregate care. One of
 2688  these visits may be in conjunction with the regular survey. The
 2689  monitoring visits may be provided through contractual
 2690  arrangements with appropriate community agencies. A registered
 2691  nurse shall serve as part of the team that inspects such
 2692  facility. The agency may waive one of the required yearly
 2693  monitoring visits for a facility that has been licensed for at
 2694  least 24 months to provide extended congregate care services,
 2695  if, during the inspection, the registered nurse determines that
 2696  extended congregate care services are being provided
 2697  appropriately, and if the facility has no class I or class II
 2698  violations and no uncorrected class III violations. Before such
 2699  decision is made, the agency shall consult with the long-term
 2700  care ombudsman council for the area in which the facility is
 2701  located to determine if any complaints have been made and
 2702  substantiated about the quality of services or care. The agency
 2703  may not waive one of the required yearly monitoring visits if
 2704  complaints have been made and substantiated.
 2705         3. Licensees Facilities that are licensed to provide
 2706  extended congregate care services shall:
 2707         a. Demonstrate the capability to meet unanticipated
 2708  resident service needs.
 2709         b. Offer a physical environment that promotes a homelike
 2710  setting, provides for resident privacy, promotes resident
 2711  independence, and allows sufficient congregate space as defined
 2712  by rule.
 2713         c. Have sufficient staff available, taking into account the
 2714  physical plant and firesafety features of the building, to
 2715  assist with the evacuation of residents in an emergency, as
 2716  necessary.
 2717         d. Adopt and follow policies and procedures that maximize
 2718  resident independence, dignity, choice, and decisionmaking to
 2719  permit residents to age in place to the extent possible, so that
 2720  moves due to changes in functional status are minimized or
 2721  avoided.
 2722         e. Allow residents or, if applicable, a resident’s
 2723  representative, designee, surrogate, guardian, or attorney in
 2724  fact to make a variety of personal choices, participate in
 2725  developing service plans, and share responsibility in
 2726  decisionmaking.
 2727         f. Implement the concept of managed risk.
 2728         g. Provide, either directly or through contract, the
 2729  services of a person licensed pursuant to part I of chapter 464.
 2730         h. In addition to the training mandated in s. 429.52,
 2731  provide specialized training as defined by rule for facility
 2732  staff.
 2733         4. Licensees Facilities licensed to provide extended
 2734  congregate care services are exempt from the criteria for
 2735  continued residency as set forth in rules adopted under s.
 2736  429.41. Licensees Facilities so licensed shall adopt their own
 2737  requirements within guidelines for continued residency set forth
 2738  by rule. However, such licensees facilities may not serve
 2739  residents who require 24-hour nursing supervision. Licensees
 2740  Facilities licensed to provide extended congregate care services
 2741  shall provide each resident with a written copy of facility
 2742  policies governing admission and retention.
 2743         5. The primary purpose of extended congregate care services
 2744  is to allow residents, as they become more impaired, the option
 2745  of remaining in a familiar setting from which they would
 2746  otherwise be disqualified for continued residency. A facility
 2747  licensed to provide extended congregate care services may also
 2748  admit an individual who exceeds the admission criteria for a
 2749  facility with a standard license, if the individual is
 2750  determined appropriate for admission to the extended congregate
 2751  care facility.
 2752         6. Before admission of an individual to a facility licensed
 2753  to provide extended congregate care services, the individual
 2754  must undergo a medical examination as provided in s. 429.26(4)
 2755  and the facility must develop a preliminary service plan for the
 2756  individual.
 2757         7. When a licensee facility can no longer provide or
 2758  arrange for services in accordance with the resident’s service
 2759  plan and needs and the licensee’s facility’s policy, the
 2760  licensee facility shall make arrangements for relocating the
 2761  person in accordance with s. 429.28(1)(k).
 2762         8. Failure to provide extended congregate care services may
 2763  result in denial of extended congregate care license renewal.
 2764         9.No later than January 1 of each year, the department, in
 2765  consultation with the agency, shall prepare and submit to the
 2766  Governor, the President of the Senate, the Speaker of the House
 2767  of Representatives, and the chairs of appropriate legislative
 2768  committees, a report on the status of, and recommendations
 2769  related to, extended congregate care services. The status report
 2770  must include, but need not be limited to, the following
 2771  information:
 2772         a.A description of the facilities licensed to provide such
 2773  services, including total number of beds licensed under this
 2774  part.
 2775         b.The number and characteristics of residents receiving
 2776  such services.
 2777         c.The types of services rendered that could not be
 2778  provided through a standard license.
 2779         d.An analysis of deficiencies cited during licensure
 2780  inspections.
 2781         e.The number of residents who required extended congregate
 2782  care services at admission and the source of admission.
 2783         f.Recommendations for statutory or regulatory changes.
 2784         g.The availability of extended congregate care to state
 2785  clients residing in facilities licensed under this part and in
 2786  need of additional services, and recommendations for
 2787  appropriations to subsidize extended congregate care services
 2788  for such persons.
 2789         h.Such other information as the department considers
 2790  appropriate.
 2791         (c)A limited nursing services license shall be issued to a
 2792  facility that provides services beyond those authorized in
 2793  paragraph (a) and as specified in this paragraph.
 2794         1.In order for limited nursing services to be provided in
 2795  a facility licensed under this part, the agency must first
 2796  determine that all requirements established in law and rule are
 2797  met and must specifically designate, on the facility’s license,
 2798  that such services may be provided. Such designation may be made
 2799  at the time of initial licensure or relicensure, or upon request
 2800  in writing by a licensee under this part and part II of chapter
 2801  408. Notification of approval or denial of such request shall be
 2802  made in accordance with part II of chapter 408. Existing
 2803  facilities qualifying to provide limited nursing services shall
 2804  have maintained a standard license and may not have been subject
 2805  to administrative sanctions that affect the health, safety, and
 2806  welfare of residents for the previous 2 years or since initial
 2807  licensure if the facility has been licensed for less than 2
 2808  years.
 2809         2.Facilities that are licensed to provide limited nursing
 2810  services shall maintain a written progress report on each person
 2811  who receives such nursing services, which report describes the
 2812  type, amount, duration, scope, and outcome of services that are
 2813  rendered and the general status of the resident’s health. A
 2814  registered nurse representing the agency shall visit such
 2815  facilities at least twice a year to monitor residents who are
 2816  receiving limited nursing services and to determine if the
 2817  facility is in compliance with applicable provisions of this
 2818  part, part II of chapter 408, and related rules. The monitoring
 2819  visits may be provided through contractual arrangements with
 2820  appropriate community agencies. A registered nurse shall also
 2821  serve as part of the team that inspects such facility.
 2822         3.A person who receives limited nursing services under
 2823  this part must meet the admission criteria established by the
 2824  agency for assisted living facilities. When a resident no longer
 2825  meets the admission criteria for a facility licensed under this
 2826  part, arrangements for relocating the person shall be made in
 2827  accordance with s. 429.28(1)(k), unless the facility is licensed
 2828  to provide extended congregate care services.
 2829         (4) In accordance with s. 408.805, an applicant or licensee
 2830  shall pay a fee for each license application submitted under
 2831  this part, part II of chapter 408, and applicable rules. The
 2832  amount of the fee shall be established by rule.
 2833         (a) The biennial license fee required of a facility is $356
 2834  $300 per license, with an additional fee of $67.50 $50 per
 2835  resident based on the total licensed resident capacity of the
 2836  facility, except that no additional fee will be assessed for
 2837  beds designated for recipients of optional state supplementation
 2838  payments provided for in s. 409.212. The total fee may not
 2839  exceed $18,000 $10,000.
 2840         (b) In addition to the total fee assessed under paragraph
 2841  (a), the agency shall require facilities that are licensed to
 2842  provide extended congregate care services under this part to pay
 2843  an additional fee per licensed facility. The amount of the
 2844  biennial fee shall be $501 $400 per license, with an additional
 2845  fee of $10 per resident based on the total licensed resident
 2846  capacity of the facility.
 2847         (c)In addition to the total fee assessed under paragraph
 2848  (a), the agency shall require facilities that are licensed to
 2849  provide limited nursing services under this part to pay an
 2850  additional fee per licensed facility. The amount of the biennial
 2851  fee shall be $250 per license, with an additional fee of $10 per
 2852  resident based on the total licensed resident capacity of the
 2853  facility.
 2854         (6)In order to determine whether the facility is
 2855  adequately protecting residents’ rights as provided in s.
 2856  429.28, the biennial survey shall include private informal
 2857  conversations with a sample of residents and consultation with
 2858  the ombudsman council in the planning and service area in which
 2859  the facility is located to discuss residents’ experiences within
 2860  the facility.
 2861         (7)An assisted living facility that has been cited within
 2862  the previous 24-month period for a class I or class II
 2863  violation, regardless of the status of any enforcement or
 2864  disciplinary action, is subject to periodic unannounced
 2865  monitoring to determine if the facility is in compliance with
 2866  this part, part II of chapter 408, and applicable rules.
 2867  Monitoring may occur through a desk review or an onsite
 2868  assessment. If the class I or class II violation relates to
 2869  providing or failing to provide nursing care, a registered nurse
 2870  must participate in at least two onsite monitoring visits within
 2871  a 12-month period.
 2872         Section 69. Subsection (7) of section 429.11, Florida
 2873  Statutes, is renumbered as subsection (6), and present
 2874  subsection (6) of that section is amended to read:
 2875         429.11 Initial application for license; provisional
 2876  license.—
 2877         (6)In addition to the license categories available in s.
 2878  408.808, a provisional license may be issued to an applicant
 2879  making initial application for licensure or making application
 2880  for a change of ownership. A provisional license shall be
 2881  limited in duration to a specific period of time not to exceed 6
 2882  months, as determined by the agency.
 2883         Section 70. Section 429.12, Florida Statutes, is amended to
 2884  read:
 2885         429.12 Sale or transfer of ownership of a facility.—It is
 2886  the intent of the Legislature to protect the rights of the
 2887  residents of an assisted living facility when the facility is
 2888  sold or the ownership thereof is transferred. Therefore, in
 2889  addition to the requirements of part II of chapter 408, whenever
 2890  a facility is sold or the ownership thereof is transferred,
 2891  including leasing:.
 2892         (1) The transferee shall notify the residents, in writing,
 2893  of the change of ownership within 7 days after receipt of the
 2894  new license.
 2895         (2)The transferor of a facility the license of which is
 2896  denied pending an administrative hearing shall, as a part of the
 2897  written change-of-ownership contract, advise the transferee that
 2898  a plan of correction must be submitted by the transferee and
 2899  approved by the agency at least 7 days before the change of
 2900  ownership and that failure to correct the condition which
 2901  resulted in the moratorium pursuant to part II of chapter 408 or
 2902  denial of licensure is grounds for denial of the transferee’s
 2903  license.
 2904         Section 71. Paragraphs (b) through (l) of subsection (1) of
 2905  section 429.14, Florida Statutes, are redesignated as paragraphs
 2906  (a) through (k), respectively, and present paragraph (a) of
 2907  subsection (1) and subsections (5) and (6) of that section are
 2908  amended to read:
 2909         429.14 Administrative penalties.—
 2910         (1) In addition to the requirements of part II of chapter
 2911  408, the agency may deny, revoke, and suspend any license issued
 2912  under this part and impose an administrative fine in the manner
 2913  provided in chapter 120 against a licensee of an assisted living
 2914  facility for a violation of any provision of this part, part II
 2915  of chapter 408, or applicable rules, or for any of the following
 2916  actions by a licensee of an assisted living facility, for the
 2917  actions of any person subject to level 2 background screening
 2918  under s. 408.809, or for the actions of any facility employee:
 2919         (a)An intentional or negligent act seriously affecting the
 2920  health, safety, or welfare of a resident of the facility.
 2921         (5) An action taken by the agency to suspend, deny, or
 2922  revoke a facility’s license under this part or part II of
 2923  chapter 408, in which the agency claims that the facility owner
 2924  or an employee of the facility has threatened the health,
 2925  safety, or welfare of a resident of the facility shall be heard
 2926  by the Division of Administrative Hearings of the Department of
 2927  Management Services within 120 days after receipt of the
 2928  facility’s request for a hearing, unless that time limitation is
 2929  waived by both parties. The administrative law judge must render
 2930  a decision within 30 days after receipt of a proposed
 2931  recommended order.
 2932         (6) The agency shall provide to the Division of Hotels and
 2933  Restaurants of the Department of Business and Professional
 2934  Regulation, on a monthly basis, a list of those assisted living
 2935  facilities that have had their licenses denied, suspended, or
 2936  revoked or that are involved in an appellate proceeding pursuant
 2937  to s. 120.60 related to the denial, suspension, or revocation of
 2938  a license. This information may be provided electronically or
 2939  through the agency’s Internet website.
 2940         Section 72. Subsections (1), (4), and (5) of section
 2941  429.17, Florida Statutes, are amended to read:
 2942         429.17 Expiration of license; renewal; conditional
 2943  license.—
 2944         (1) Limited nursing, Extended congregate care, and limited
 2945  mental health licenses shall expire at the same time as the
 2946  facility’s standard license, regardless of when issued.
 2947         (4) In addition to the license categories available in s.
 2948  408.808, a conditional license may be issued to an applicant for
 2949  license renewal if the applicant fails to meet all standards and
 2950  requirements for licensure. A conditional license issued under
 2951  this subsection shall be limited in duration to a specific
 2952  period of time not to exceed 6 months, as determined by the
 2953  agency, and shall be accompanied by an agency-approved plan of
 2954  correction.
 2955         (5) When an extended congregate care or limited nursing
 2956  license is requested during a facility’s biennial license
 2957  period, the fee shall be prorated in order to permit the
 2958  additional license to expire at the end of the biennial license
 2959  period. The fee shall be calculated as of the date the
 2960  additional license application is received by the agency.
 2961         Section 73. Subsection (7) of section 429.19, Florida
 2962  Statutes, is amended to read:
 2963         429.19 Violations; imposition of administrative fines;
 2964  grounds.—
 2965         (7) In addition to any administrative fines imposed, the
 2966  agency may assess a survey or monitoring fee, equal to the
 2967  lesser of one half of the facility’s biennial license and bed
 2968  fee or $500, to cover the cost of conducting initial complaint
 2969  investigations that result in the finding of a violation that
 2970  was the subject of the complaint or to monitor the health,
 2971  safety, or security of residents under s. 429.07(7) monitoring
 2972  visits conducted under s. 429.28(3)(c) to verify the correction
 2973  of the violations.
 2974         Section 74. Subsections (6) through (10) of section 429.23,
 2975  Florida Statutes, are renumbered as subsections (5) through (9),
 2976  respectively, and present subsection (5) of that section is
 2977  amended to read:
 2978         429.23 Internal risk management and quality assurance
 2979  program; adverse incidents and reporting requirements.—
 2980         (5)Each facility shall report monthly to the agency any
 2981  liability claim filed against it. The report must include the
 2982  name of the resident, the dates of the incident leading to the
 2983  claim, if applicable, and the type of injury or violation of
 2984  rights alleged to have occurred. This report is not discoverable
 2985  in any civil or administrative action, except in such actions
 2986  brought by the agency to enforce the provisions of this part.
 2987         Section 75. Paragraph (a) of subsection (1) and subsection
 2988  (2) of section 429.255, Florida Statutes, are amended to read:
 2989         429.255 Use of personnel; emergency care.—
 2990         (1)(a) Persons under contract to the facility or, facility
 2991  staff, or volunteers, who are licensed according to part I of
 2992  chapter 464, or those persons exempt under s. 464.022(1), and
 2993  others as defined by rule, may administer medications to
 2994  residents, take residents’ vital signs, manage individual weekly
 2995  pill organizers for residents who self-administer medication,
 2996  give prepackaged enemas ordered by a physician, observe
 2997  residents, document observations on the appropriate resident’s
 2998  record, report observations to the resident’s physician, and
 2999  contract or allow residents or a resident’s representative,
 3000  designee, surrogate, guardian, or attorney in fact to contract
 3001  with a third party, provided residents meet the criteria for
 3002  appropriate placement as defined in s. 429.26. Persons under
 3003  contract to the facility or facility staff who are licensed
 3004  according to part I of chapter 464 may provide limited nursing
 3005  services. Nursing assistants certified pursuant to part II of
 3006  chapter 464 may take residents’ vital signs as directed by a
 3007  licensed nurse or physician. The facility is responsible for
 3008  maintaining documentation of services provided under this
 3009  paragraph as required by rule and ensuring that staff are
 3010  adequately trained to monitor residents receiving these
 3011  services.
 3012         (2) In facilities licensed to provide extended congregate
 3013  care, persons under contract to the facility or, facility staff,
 3014  or volunteers, who are licensed according to part I of chapter
 3015  464, or those persons exempt under s. 464.022(1), or those
 3016  persons certified as nursing assistants pursuant to part II of
 3017  chapter 464, may also perform all duties within the scope of
 3018  their license or certification, as approved by the facility
 3019  administrator and pursuant to this part.
 3020         Section 76. Subsection (3) of section 429.28, Florida
 3021  Statutes, is amended to read:
 3022         429.28 Resident bill of rights.—
 3023         (3)(a)The agency shall conduct a survey to determine
 3024  general compliance with facility standards and compliance with
 3025  residents’ rights as a prerequisite to initial licensure or
 3026  licensure renewal.
 3027         (b)In order to determine whether the facility is
 3028  adequately protecting residents’ rights, the biennial survey
 3029  shall include private informal conversations with a sample of
 3030  residents and consultation with the ombudsman council in the
 3031  planning and service area in which the facility is located to
 3032  discuss residents’ experiences within the facility.
 3033         (c)During any calendar year in which no survey is
 3034  conducted, the agency shall conduct at least one monitoring
 3035  visit of each facility cited in the previous year for a class I
 3036  or class II violation, or more than three uncorrected class III
 3037  violations.
 3038         (d)The agency may conduct periodic followup inspections as
 3039  necessary to monitor the compliance of facilities with a history
 3040  of any class I, class II, or class III violations that threaten
 3041  the health, safety, or security of residents.
 3042         (e)The agency may conduct complaint investigations as
 3043  warranted to investigate any allegations of noncompliance with
 3044  requirements required under this part or rules adopted under
 3045  this part.
 3046         Section 77. Subsection (2) of section 429.35, Florida
 3047  Statutes, is amended to read:
 3048         429.35 Maintenance of records; reports.—
 3049         (2) Within 60 days after the date of the biennial
 3050  inspection visit required under s. 408.811 or within 30 days
 3051  after the date of any interim visit, the agency shall forward
 3052  the results of the inspection to the local ombudsman council in
 3053  whose planning and service area, as defined in part II of
 3054  chapter 400, the facility is located; to at least one public
 3055  library or, in the absence of a public library, the county seat
 3056  in the county in which the inspected assisted living facility is
 3057  located; and, when appropriate, to the district Adult Services
 3058  and Mental Health Program Offices. This information may be
 3059  provided electronically or through the agency’s Internet
 3060  website.
 3061         Section 78. Paragraphs (i) and (j) of subsection (1) of
 3062  section 429.41, Florida Statutes, are amended to read:
 3063         429.41 Rules establishing standards.—
 3064         (1) It is the intent of the Legislature that rules
 3065  published and enforced pursuant to this section shall include
 3066  criteria by which a reasonable and consistent quality of
 3067  resident care and quality of life may be ensured and the results
 3068  of such resident care may be demonstrated. Such rules shall also
 3069  ensure a safe and sanitary environment that is residential and
 3070  noninstitutional in design or nature. It is further intended
 3071  that reasonable efforts be made to accommodate the needs and
 3072  preferences of residents to enhance the quality of life in a
 3073  facility. The agency, in consultation with the department, may
 3074  adopt rules to administer the requirements of part II of chapter
 3075  408. In order to provide safe and sanitary facilities and the
 3076  highest quality of resident care accommodating the needs and
 3077  preferences of residents, the department, in consultation with
 3078  the agency, the Department of Children and Family Services, and
 3079  the Department of Health, shall adopt rules, policies, and
 3080  procedures to administer this part, which must include
 3081  reasonable and fair minimum standards in relation to:
 3082         (i) Facilities holding an a limited nursing, extended
 3083  congregate care, or limited mental health license.
 3084         (j) The establishment of specific criteria to define
 3085  appropriateness of resident admission and continued residency in
 3086  a facility holding a standard, limited nursing, extended
 3087  congregate care, and limited mental health license.
 3088         Section 79. Subsections (1) and (2) of section 429.53,
 3089  Florida Statutes, are amended to read:
 3090         429.53 Consultation by the agency.—
 3091         (1) The area offices of licensure and certification of the
 3092  agency shall provide consultation to the following upon request:
 3093         (a) A licensee of a facility.
 3094         (b) A person interested in obtaining a license to operate a
 3095  facility under this part.
 3096         (2) As used in this section, “consultation” includes:
 3097         (a) An explanation of the requirements of this part and
 3098  rules adopted pursuant thereto;
 3099         (b) An explanation of the license application and renewal
 3100  procedures;
 3101         (c)The provision of a checklist of general local and state
 3102  approvals required prior to constructing or developing a
 3103  facility and a listing of the types of agencies responsible for
 3104  such approvals;
 3105         (d)An explanation of benefits and financial assistance
 3106  available to a recipient of supplemental security income
 3107  residing in a facility;
 3108         (c)(e) Any other information which the agency deems
 3109  necessary to promote compliance with the requirements of this
 3110  part; and
 3111         (f)A preconstruction review of a facility to ensure
 3112  compliance with agency rules and this part.
 3113         Section 80. Subsections (1) and (2) of section 429.54,
 3114  Florida Statutes, are renumbered as subsections (2) and (3),
 3115  respectively, and a new subsection (1) is added to that section
 3116  to read:
 3117         429.54 Collection of information; local subsidy.—
 3118         (1)A facility that is licensed under this part must report
 3119  electronically to the agency semiannually data related to the
 3120  facility, including, but not limited to, the total number of
 3121  residents, the number of residents who are receiving limited
 3122  mental health services, the number of residents who are
 3123  receiving extended congregate care services, the number of
 3124  residents who are receiving limited nursing services, and
 3125  professional staffing employed by or under contract with the
 3126  licensee to provide resident services. The department, in
 3127  consultation with the agency, shall adopt rules to administer
 3128  this subsection.
 3129         Section 81. Subsections (1) and (5) of section 429.71,
 3130  Florida Statutes, are amended to read:
 3131         429.71 Classification of violations deficiencies;
 3132  administrative fines.—
 3133         (1) In addition to the requirements of part II of chapter
 3134  408 and in addition to any other liability or penalty provided
 3135  by law, the agency may impose an administrative fine on a
 3136  provider according to the following classification:
 3137         (a) Class I violations are defined in s. 408.813 those
 3138  conditions or practices related to the operation and maintenance
 3139  of an adult family-care home or to the care of residents which
 3140  the agency determines present an imminent danger to the
 3141  residents or guests of the facility or a substantial probability
 3142  that death or serious physical or emotional harm would result
 3143  therefrom. The condition or practice that constitutes a class I
 3144  violation must be abated or eliminated within 24 hours, unless a
 3145  fixed period, as determined by the agency, is required for
 3146  correction. A class I violation deficiency is subject to an
 3147  administrative fine in an amount not less than $500 and not
 3148  exceeding $1,000 for each violation. A fine may be levied
 3149  notwithstanding the correction of the deficiency.
 3150         (b) Class II violations are defined in s. 408.813 those
 3151  conditions or practices related to the operation and maintenance
 3152  of an adult family-care home or to the care of residents which
 3153  the agency determines directly threaten the physical or
 3154  emotional health, safety, or security of the residents, other
 3155  than class I violations. A class II violation is subject to an
 3156  administrative fine in an amount not less than $250 and not
 3157  exceeding $500 for each violation. A citation for a class II
 3158  violation must specify the time within which the violation is
 3159  required to be corrected. If a class II violation is corrected
 3160  within the time specified, no civil penalty shall be imposed,
 3161  unless it is a repeated offense.
 3162         (c) Class III violations are defined in s. 408.813 those
 3163  conditions or practices related to the operation and maintenance
 3164  of an adult family-care home or to the care of residents which
 3165  the agency determines indirectly or potentially threaten the
 3166  physical or emotional health, safety, or security of residents,
 3167  other than class I or class II violations. A class III violation
 3168  is subject to an administrative fine in an amount not less than
 3169  $100 and not exceeding $250 for each violation. A citation for a
 3170  class III violation shall specify the time within which the
 3171  violation is required to be corrected. If a class III violation
 3172  is corrected within the time specified, no civil penalty shall
 3173  be imposed, unless it is a repeated violation offense.
 3174         (d) Class IV violations are defined in s. 408.813 those
 3175  conditions or occurrences related to the operation and
 3176  maintenance of an adult family-care home, or related to the
 3177  required reports, forms, or documents, which do not have the
 3178  potential of negatively affecting the residents. A provider that
 3179  does not correct A class IV violation within the time limit
 3180  specified by the agency is subject to an administrative fine in
 3181  an amount not less than $50 and not exceeding $100 for each
 3182  violation. Any class IV violation that is corrected during the
 3183  time the agency survey is conducted will be identified as an
 3184  agency finding and not as a violation, unless it is a repeat
 3185  violation.
 3186         (5)As an alternative to or in conjunction with an
 3187  administrative action against a provider, the agency may request
 3188  a plan of corrective action that demonstrates a good faith
 3189  effort to remedy each violation by a specific date, subject to
 3190  the approval of the agency.
 3191         Section 82. Paragraphs (b) through (e) of subsection (2) of
 3192  section 429.911, Florida Statutes, are redesignated as
 3193  paragraphs (a) through (d), respectively, and present paragraph
 3194  (a) of that subsection is amended to read:
 3195         429.911 Denial, suspension, revocation of license;
 3196  emergency action; administrative fines; investigations and
 3197  inspections.—
 3198         (2) Each of the following actions by the owner of an adult
 3199  day care center or by its operator or employee is a ground for
 3200  action by the agency against the owner of the center or its
 3201  operator or employee:
 3202         (a)An intentional or negligent act materially affecting
 3203  the health or safety of center participants.
 3204         Section 83. Section 429.915, Florida Statutes, is amended
 3205  to read:
 3206         429.915 Conditional license.—In addition to the license
 3207  categories available in part II of chapter 408, the agency may
 3208  issue a conditional license to an applicant for license renewal
 3209  or change of ownership if the applicant fails to meet all
 3210  standards and requirements for licensure. A conditional license
 3211  issued under this subsection must be limited to a specific
 3212  period not exceeding 6 months, as determined by the agency, and
 3213  must be accompanied by an approved plan of correction.
 3214         Section 84. Paragraphs (b) and (h) of subsection (3) of
 3215  section 430.80, Florida Statutes, are amended to read:
 3216         430.80 Implementation of a teaching nursing home pilot
 3217  project.—
 3218         (3) To be designated as a teaching nursing home, a nursing
 3219  home licensee must, at a minimum:
 3220         (b) Participate in a nationally recognized accreditation
 3221  program and hold a valid accreditation, such as the
 3222  accreditation awarded by The Joint Commission on Accreditation
 3223  of Healthcare Organizations;
 3224         (h) Maintain insurance coverage pursuant to s.
 3225  400.141(1)(q)(s) or proof of financial responsibility in a
 3226  minimum amount of $750,000. Such proof of financial
 3227  responsibility may include:
 3228         1. Maintaining an escrow account consisting of cash or
 3229  assets eligible for deposit in accordance with s. 625.52; or
 3230         2. Obtaining and maintaining pursuant to chapter 675 an
 3231  unexpired, irrevocable, nontransferable and nonassignable letter
 3232  of credit issued by any bank or savings association organized
 3233  and existing under the laws of this state or any bank or savings
 3234  association organized under the laws of the United States that
 3235  has its principal place of business in this state or has a
 3236  branch office which is authorized to receive deposits in this
 3237  state. The letter of credit shall be used to satisfy the
 3238  obligation of the facility to the claimant upon presentment of a
 3239  final judgment indicating liability and awarding damages to be
 3240  paid by the facility or upon presentment of a settlement
 3241  agreement signed by all parties to the agreement when such final
 3242  judgment or settlement is a result of a liability claim against
 3243  the facility.
 3244         Section 85. Paragraph (a) of subsection (2) of section
 3245  440.13, Florida Statutes, is amended to read:
 3246         440.13 Medical services and supplies; penalty for
 3247  violations; limitations.—
 3248         (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.—
 3249         (a) Subject to the limitations specified elsewhere in this
 3250  chapter, the employer shall furnish to the employee such
 3251  medically necessary remedial treatment, care, and attendance for
 3252  such period as the nature of the injury or the process of
 3253  recovery may require, which is in accordance with established
 3254  practice parameters and protocols of treatment as provided for
 3255  in this chapter, including medicines, medical supplies, durable
 3256  medical equipment, orthoses, prostheses, and other medically
 3257  necessary apparatus. Remedial treatment, care, and attendance,
 3258  including work-hardening programs or pain-management programs
 3259  accredited by the Commission on Accreditation of Rehabilitation
 3260  Facilities or The Joint Commission on the Accreditation of
 3261  Health Organizations or pain-management programs affiliated with
 3262  medical schools, shall be considered as covered treatment only
 3263  when such care is given based on a referral by a physician as
 3264  defined in this chapter. Medically necessary treatment, care,
 3265  and attendance does not include chiropractic services in excess
 3266  of 24 treatments or rendered 12 weeks beyond the date of the
 3267  initial chiropractic treatment, whichever comes first, unless
 3268  the carrier authorizes additional treatment or the employee is
 3269  catastrophically injured.
 3270  
 3271  Failure of the carrier to timely comply with this subsection
 3272  shall be a violation of this chapter and the carrier shall be
 3273  subject to penalties as provided for in s. 440.525.
 3274         Section 86. Subsection (11) is added to section 483.201,
 3275  Florida Statutes, to read:
 3276         483.201 Grounds for disciplinary action against clinical
 3277  laboratories.—In addition to the requirements of part II of
 3278  chapter 408, the following acts constitute grounds for which a
 3279  disciplinary action specified in s. 483.221 may be taken against
 3280  a clinical laboratory:
 3281         (11) A blood establishment that collects blood or blood
 3282  components from volunteer donors failing to disclose information
 3283  concerning its activities as required by s. 381.06014. Each day
 3284  of violation constitutes a separate violation and each separate
 3285  violation is subject to a separate fine. If multiple licensed
 3286  establishments operated by a single business entity fail to meet
 3287  such disclosure requirements, the agency may assess fines
 3288  against only one of the business entity’s clinical laboratory
 3289  licenses. The total administrative fine may not exceed $10,000
 3290  for each annual reporting period.
 3291         Section 87. Section 483.294, Florida Statutes, is amended
 3292  to read:
 3293         483.294 Inspection of centers.—In accordance with s.
 3294  408.811, the agency shall biennially, at least once annually,
 3295  inspect the premises and operations of all centers subject to
 3296  licensure under this part.
 3297         Section 88. Subsection (23) and paragraph (a) of subsection
 3298  (53) of section 499.003, Florida Statutes, are amended to read:
 3299         499.003 Definitions of terms used in this part.—As used in
 3300  this part, the term:
 3301         (23) “Health care entity” means a closed pharmacy or any
 3302  person, organization, or business entity that provides
 3303  diagnostic, medical, surgical, or dental treatment or care, or
 3304  chronic or rehabilitative care, but does not include any
 3305  wholesale distributor or retail pharmacy licensed under state
 3306  law to deal in prescription drugs. However, a blood
 3307  establishment may be a health care entity and engage in the
 3308  wholesale distribution of prescription drugs under s.
 3309  499.01(2)(g)1.c.
 3310         (53) “Wholesale distribution” means distribution of
 3311  prescription drugs to persons other than a consumer or patient,
 3312  but does not include:
 3313         (a) Any of the following activities, which is not a
 3314  violation of s. 499.005(21) if such activity is conducted in
 3315  accordance with s. 499.01(2)(g):
 3316         1. The purchase or other acquisition by a hospital or other
 3317  health care entity that is a member of a group purchasing
 3318  organization of a prescription drug for its own use from the
 3319  group purchasing organization or from other hospitals or health
 3320  care entities that are members of that organization.
 3321         2. The sale, purchase, or trade of a prescription drug or
 3322  an offer to sell, purchase, or trade a prescription drug by a
 3323  charitable organization described in s. 501(c)(3) of the
 3324  Internal Revenue Code of 1986, as amended and revised, to a
 3325  nonprofit affiliate of the organization to the extent otherwise
 3326  permitted by law.
 3327         3. The sale, purchase, or trade of a prescription drug or
 3328  an offer to sell, purchase, or trade a prescription drug among
 3329  hospitals or other health care entities that are under common
 3330  control. For purposes of this subparagraph, “common control”
 3331  means the power to direct or cause the direction of the
 3332  management and policies of a person or an organization, whether
 3333  by ownership of stock, by voting rights, by contract, or
 3334  otherwise.
 3335         4. The sale, purchase, trade, or other transfer of a
 3336  prescription drug from or for any federal, state, or local
 3337  government agency or any entity eligible to purchase
 3338  prescription drugs at public health services prices pursuant to
 3339  Pub. L. No. 102-585, s. 602 to a contract provider or its
 3340  subcontractor for eligible patients of the agency or entity
 3341  under the following conditions:
 3342         a. The agency or entity must obtain written authorization
 3343  for the sale, purchase, trade, or other transfer of a
 3344  prescription drug under this subparagraph from the State Surgeon
 3345  General or his or her designee.
 3346         b. The contract provider or subcontractor must be
 3347  authorized by law to administer or dispense prescription drugs.
 3348         c. In the case of a subcontractor, the agency or entity
 3349  must be a party to and execute the subcontract.
 3350         d. A contract provider or subcontractor must maintain
 3351  separate and apart from other prescription drug inventory any
 3352  prescription drugs of the agency or entity in its possession.
 3353         d.e. The contract provider and subcontractor must maintain
 3354  and produce immediately for inspection all records of movement
 3355  or transfer of all the prescription drugs belonging to the
 3356  agency or entity, including, but not limited to, the records of
 3357  receipt and disposition of prescription drugs. Each contractor
 3358  and subcontractor dispensing or administering these drugs must
 3359  maintain and produce records documenting the dispensing or
 3360  administration. Records that are required to be maintained
 3361  include, but are not limited to, a perpetual inventory itemizing
 3362  drugs received and drugs dispensed by prescription number or
 3363  administered by patient identifier, which must be submitted to
 3364  the agency or entity quarterly.
 3365         e.f. The contract provider or subcontractor may administer
 3366  or dispense the prescription drugs only to the eligible patients
 3367  of the agency or entity or must return the prescription drugs
 3368  for or to the agency or entity. The contract provider or
 3369  subcontractor must require proof from each person seeking to
 3370  fill a prescription or obtain treatment that the person is an
 3371  eligible patient of the agency or entity and must, at a minimum,
 3372  maintain a copy of this proof as part of the records of the
 3373  contractor or subcontractor required under sub-subparagraph d.
 3374  e.
 3375         f.g. In addition to the departmental inspection authority
 3376  set forth in s. 499.051, the establishment of the contract
 3377  provider and subcontractor and all records pertaining to
 3378  prescription drugs subject to this subparagraph shall be subject
 3379  to inspection by the agency or entity. All records relating to
 3380  prescription drugs of a manufacturer under this subparagraph
 3381  shall be subject to audit by the manufacturer of those drugs,
 3382  without identifying individual patient information.
 3383         Section 89. Subsection (21) of section 499.005, Florida
 3384  Statutes, is amended to read:
 3385         499.005 Prohibited acts.—It is unlawful for a person to
 3386  perform or cause the performance of any of the following acts in
 3387  this state:
 3388         (21) The wholesale distribution of any prescription drug
 3389  that was:
 3390         (a) Purchased by a public or private hospital or other
 3391  health care entity, except as authorized in s. 499.01(2)(g)1.c.;
 3392  or
 3393         (b) Donated or supplied at a reduced price to a charitable
 3394  organization.
 3395         Section 90. Paragraphs (a) and (g) of subsection (2) of
 3396  section 499.01, Florida Statutes, are amended to read:
 3397         499.01 Permits.—
 3398         (2) The following permits are established:
 3399         (a) Prescription drug manufacturer permit.—A prescription
 3400  drug manufacturer permit is required for any person that is a
 3401  manufacturer of a prescription drug and that manufactures or
 3402  distributes such prescription drugs in this state.
 3403         1. A person that operates an establishment permitted as a
 3404  prescription drug manufacturer may engage in wholesale
 3405  distribution of prescription drugs manufactured at that
 3406  establishment and must comply with all of the provisions of this
 3407  part, except s. 499.01212, and the rules adopted under this
 3408  part, except s. 499.01212, that apply to a wholesale
 3409  distributor.
 3410         2. A prescription drug manufacturer must comply with all
 3411  appropriate state and federal good manufacturing practices.
 3412         3. A blood establishment as defined in s. 381.06014,
 3413  operating in a manner consistent with the provisions of Title 21
 3414  C.F.R. Parts 211 and 600-640, and manufacturing only the
 3415  prescription drugs described in s. 499.003(53)(d) is not
 3416  required to be permitted as a prescription drug manufacturer
 3417  under this paragraph or register products under s. 499.015.
 3418         (g) Restricted prescription drug distributor permit.—
 3419         1. A restricted prescription drug distributor permit is
 3420  required for:
 3421         a. Any person that engages in the distribution of a
 3422  prescription drug, which distribution is not considered
 3423  “wholesale distribution” under s. 499.003(53)(a).
 3424         b.1.Any A person who engages in the receipt or
 3425  distribution of a prescription drug in this state for the
 3426  purpose of processing its return or its destruction must obtain
 3427  a permit as a restricted prescription drug distributor if such
 3428  person is not the person initiating the return, the prescription
 3429  drug wholesale supplier of the person initiating the return, or
 3430  the manufacturer of the drug.
 3431         c.A blood establishment located in this state that
 3432  collects blood and blood components only from volunteer donors
 3433  as defined in s. 381.06014 or pursuant to an authorized
 3434  practitioner’s order for medical treatment or therapy and
 3435  engages in the wholesale distribution of a prescription drug not
 3436  described in s. 499.003(53)(d) to a health care entity. The
 3437  health care entity receiving a prescription drug distributed
 3438  under this sub-subparagraph must be licensed as a closed
 3439  pharmacy or provide health care services at that establishment.
 3440  The blood establishment must operate in accordance with s.
 3441  381.06014 and may distribute only:
 3442         (I) Prescription drugs indicated for a bleeding or clotting
 3443  disorder or anemia;
 3444         (II) Blood-collection containers approved under s. 505 of
 3445  the federal act;
 3446         (III) Drugs that are blood derivatives, or a recombinant or
 3447  synthetic form of a blood derivative; or
 3448         (IV) Prescription drugs identified in rules adopted by the
 3449  department which are essential to services performed or provided
 3450  by blood establishments and authorized for distribution by blood
 3451  establishments under federal law,
 3452  
 3453  as long as all of the health care services provided by the blood
 3454  establishment are related to its activities as a registered
 3455  blood establishment or the health care services consist of
 3456  collecting, processing, storing, or administering human
 3457  hematopoietic stem cells or progenitor cells or performing
 3458  diagnostic testing of specimens if such specimens are tested
 3459  together with specimens undergoing routine donor testing.
 3460         2. Storage, handling, and recordkeeping of these
 3461  distributions by a person permitted as a restricted prescription
 3462  drug distributor must comply with the requirements for wholesale
 3463  distributors under s. 499.0121, but not those set forth in s.
 3464  499.01212 if the distribution occurs pursuant to sub
 3465  subparagraph 1.a. or sub-subparagraph 1.b.
 3466         3. A person who applies for a permit as a restricted
 3467  prescription drug distributor, or for the renewal of such a
 3468  permit, must provide to the department the information required
 3469  under s. 499.012.
 3470         4. The department may adopt rules regarding the
 3471  distribution of prescription drugs by hospitals, health care
 3472  entities, charitable organizations, or other persons not
 3473  involved in wholesale distribution, and blood establishments;
 3474  which rules are necessary for the protection of the public
 3475  health, safety, and welfare. The department may adopt rules
 3476  related to the transportation, storage, and recordkeeping of
 3477  prescription drugs which are essential to services performed or
 3478  provided by a blood establishment, including requirements for
 3479  the use of prescription drugs in mobile blood-collection
 3480  vehicles.
 3481         Section 91. Paragraph (i) is added to subsection (3) of
 3482  section 499.01212, Florida Statutes, to read:
 3483         499.01212 Pedigree paper.—
 3484         (3) EXCEPTIONS.—A pedigree paper is not required for:
 3485         (i)The wholesale distribution of prescription drugs
 3486  contained within a sealed medical convenience kit if the kit:
 3487         1.Is assembled in an establishment that is registered as a
 3488  medical device manufacturer with the Food and Drug
 3489  Administration; and
 3490         2.Does not contain any controlled substance that appears
 3491  in any schedule contained in or subject to chapter 893 or the
 3492  federal Comprehensive Drug Abuse Prevention and Control Act of
 3493  1970.
 3494         Section 92. Subsection (1) of section 627.645, Florida
 3495  Statutes, is amended to read:
 3496         627.645 Denial of health insurance claims restricted.—
 3497         (1) No claim for payment under a health insurance policy or
 3498  self-insured program of health benefits for treatment, care, or
 3499  services in a licensed hospital which is accredited by The Joint
 3500  Commission on the Accreditation of Hospitals, the American
 3501  Osteopathic Association, or the Commission on the Accreditation
 3502  of Rehabilitative Facilities shall be denied because such
 3503  hospital lacks major surgical facilities and is primarily of a
 3504  rehabilitative nature, if such rehabilitation is specifically
 3505  for treatment of physical disability.
 3506         Section 93. Paragraph (c) of subsection (2) of section
 3507  627.668, Florida Statutes, is amended to read:
 3508         627.668 Optional coverage for mental and nervous disorders
 3509  required; exception.—
 3510         (2) Under group policies or contracts, inpatient hospital
 3511  benefits, partial hospitalization benefits, and outpatient
 3512  benefits consisting of durational limits, dollar amounts,
 3513  deductibles, and coinsurance factors shall not be less favorable
 3514  than for physical illness generally, except that:
 3515         (c) Partial hospitalization benefits shall be provided
 3516  under the direction of a licensed physician. For purposes of
 3517  this part, the term “partial hospitalization services” is
 3518  defined as those services offered by a program accredited by The
 3519  Joint Commission on Accreditation of Hospitals (JCAH) or in
 3520  compliance with equivalent standards. Alcohol rehabilitation
 3521  programs accredited by The Joint Commission on Accreditation of
 3522  Hospitals or approved by the state and licensed drug abuse
 3523  rehabilitation programs shall also be qualified providers under
 3524  this section. In any benefit year, if partial hospitalization
 3525  services or a combination of inpatient and partial
 3526  hospitalization are utilized, the total benefits paid for all
 3527  such services shall not exceed the cost of 30 days of inpatient
 3528  hospitalization for psychiatric services, including physician
 3529  fees, which prevail in the community in which the partial
 3530  hospitalization services are rendered. If partial
 3531  hospitalization services benefits are provided beyond the limits
 3532  set forth in this paragraph, the durational limits, dollar
 3533  amounts, and coinsurance factors thereof need not be the same as
 3534  those applicable to physical illness generally.
 3535         Section 94. Subsection (3) of section 627.669, Florida
 3536  Statutes, is amended to read:
 3537         627.669 Optional coverage required for substance abuse
 3538  impaired persons; exception.—
 3539         (3) The benefits provided under this section shall be
 3540  applicable only if treatment is provided by, or under the
 3541  supervision of, or is prescribed by, a licensed physician or
 3542  licensed psychologist and if services are provided in a program
 3543  accredited by The Joint Commission on Accreditation of Hospitals
 3544  or approved by the state.
 3545         Section 95. Paragraph (a) of subsection (1) of section
 3546  627.736, Florida Statutes, is amended to read:
 3547         627.736 Required personal injury protection benefits;
 3548  exclusions; priority; claims.—
 3549         (1) REQUIRED BENEFITS.—Every insurance policy complying
 3550  with the security requirements of s. 627.733 shall provide
 3551  personal injury protection to the named insured, relatives
 3552  residing in the same household, persons operating the insured
 3553  motor vehicle, passengers in such motor vehicle, and other
 3554  persons struck by such motor vehicle and suffering bodily injury
 3555  while not an occupant of a self-propelled vehicle, subject to
 3556  the provisions of subsection (2) and paragraph (4)(e), to a
 3557  limit of $10,000 for loss sustained by any such person as a
 3558  result of bodily injury, sickness, disease, or death arising out
 3559  of the ownership, maintenance, or use of a motor vehicle as
 3560  follows:
 3561         (a) Medical benefits.—Eighty percent of all reasonable
 3562  expenses for medically necessary medical, surgical, X-ray,
 3563  dental, and rehabilitative services, including prosthetic
 3564  devices, and medically necessary ambulance, hospital, and
 3565  nursing services. However, the medical benefits shall provide
 3566  reimbursement only for such services and care that are lawfully
 3567  provided, supervised, ordered, or prescribed by a physician
 3568  licensed under chapter 458 or chapter 459, a dentist licensed
 3569  under chapter 466, or a chiropractic physician licensed under
 3570  chapter 460 or that are provided by any of the following persons
 3571  or entities:
 3572         1. A hospital or ambulatory surgical center licensed under
 3573  chapter 395.
 3574         2. A person or entity licensed under ss. 401.2101-401.45
 3575  that provides emergency transportation and treatment.
 3576         3. An entity wholly owned by one or more physicians
 3577  licensed under chapter 458 or chapter 459, chiropractic
 3578  physicians licensed under chapter 460, or dentists licensed
 3579  under chapter 466 or by such practitioner or practitioners and
 3580  the spouse, parent, child, or sibling of that practitioner or
 3581  those practitioners.
 3582         4. An entity wholly owned, directly or indirectly, by a
 3583  hospital or hospitals.
 3584         5. A health care clinic licensed under ss. 400.990-400.995
 3585  that is:
 3586         a. Accredited by The Joint Commission on Accreditation of
 3587  Healthcare Organizations, the American Osteopathic Association,
 3588  the Commission on Accreditation of Rehabilitation Facilities, or
 3589  the Accreditation Association for Ambulatory Health Care, Inc.;
 3590  or
 3591         b. A health care clinic that:
 3592         (I) Has a medical director licensed under chapter 458,
 3593  chapter 459, or chapter 460;
 3594         (II) Has been continuously licensed for more than 3 years
 3595  or is a publicly traded corporation that issues securities
 3596  traded on an exchange registered with the United States
 3597  Securities and Exchange Commission as a national securities
 3598  exchange; and
 3599         (III) Provides at least four of the following medical
 3600  specialties:
 3601         (A) General medicine.
 3602         (B) Radiography.
 3603         (C) Orthopedic medicine.
 3604         (D) Physical medicine.
 3605         (E) Physical therapy.
 3606         (F) Physical rehabilitation.
 3607         (G) Prescribing or dispensing outpatient prescription
 3608  medication.
 3609         (H) Laboratory services.
 3610  
 3611  The Financial Services Commission shall adopt by rule the form
 3612  that must be used by an insurer and a health care provider
 3613  specified in subparagraph 3., subparagraph 4., or subparagraph
 3614  5. to document that the health care provider meets the criteria
 3615  of this paragraph, which rule must include a requirement for a
 3616  sworn statement or affidavit.
 3617  
 3618  Only insurers writing motor vehicle liability insurance in this
 3619  state may provide the required benefits of this section, and no
 3620  such insurer shall require the purchase of any other motor
 3621  vehicle coverage other than the purchase of property damage
 3622  liability coverage as required by s. 627.7275 as a condition for
 3623  providing such required benefits. Insurers may not require that
 3624  property damage liability insurance in an amount greater than
 3625  $10,000 be purchased in conjunction with personal injury
 3626  protection. Such insurers shall make benefits and required
 3627  property damage liability insurance coverage available through
 3628  normal marketing channels. Any insurer writing motor vehicle
 3629  liability insurance in this state who fails to comply with such
 3630  availability requirement as a general business practice shall be
 3631  deemed to have violated part IX of chapter 626, and such
 3632  violation shall constitute an unfair method of competition or an
 3633  unfair or deceptive act or practice involving the business of
 3634  insurance; and any such insurer committing such violation shall
 3635  be subject to the penalties afforded in such part, as well as
 3636  those which may be afforded elsewhere in the insurance code.
 3637         Section 96. Section 633.081, Florida Statutes, is amended
 3638  to read:
 3639         633.081 Inspection of buildings and equipment; orders;
 3640  firesafety inspection training requirements; certification;
 3641  disciplinary action.—The State Fire Marshal and her or his
 3642  agents shall, at any reasonable hour, when the department has
 3643  reasonable cause to believe that a violation of this chapter or
 3644  s. 509.215, or a rule promulgated thereunder, or a minimum
 3645  firesafety code adopted by a local authority, may exist, inspect
 3646  any and all buildings and structures which are subject to the
 3647  requirements of this chapter or s. 509.215 and rules promulgated
 3648  thereunder. The authority to inspect shall extend to all
 3649  equipment, vehicles, and chemicals which are located within the
 3650  premises of any such building or structure. The State Fire
 3651  Marshal and her or his agents shall inspect nursing homes
 3652  licensed under part II of chapter 400 only once every calendar
 3653  year and upon receiving a complaint forming the basis of a
 3654  reasonable cause to believe that a violation of this chapter or
 3655  s. 509.215, or a rule promulgated thereunder, or a minimum
 3656  firesafety code adopted by a local authority may exist and upon
 3657  identifying such a violation in the course of conducting
 3658  orientation or training activities within a nursing home.
 3659         (1) Each county, municipality, and special district that
 3660  has firesafety enforcement responsibilities shall employ or
 3661  contract with a firesafety inspector. The firesafety inspector
 3662  must conduct all firesafety inspections that are required by
 3663  law. The governing body of a county, municipality, or special
 3664  district that has firesafety enforcement responsibilities may
 3665  provide a schedule of fees to pay only the costs of inspections
 3666  conducted pursuant to this subsection and related administrative
 3667  expenses. Two or more counties, municipalities, or special
 3668  districts that have firesafety enforcement responsibilities may
 3669  jointly employ or contract with a firesafety inspector.
 3670         (2) Every firesafety inspection conducted pursuant to state
 3671  or local firesafety requirements shall be by a person certified
 3672  as having met the inspection training requirements set by the
 3673  State Fire Marshal. Such person shall:
 3674         (a) Be a high school graduate or the equivalent as
 3675  determined by the department;
 3676         (b) Not have been found guilty of, or having pleaded guilty
 3677  or nolo contendere to, a felony or a crime punishable by
 3678  imprisonment of 1 year or more under the law of the United
 3679  States, or of any state thereof, which involves moral turpitude,
 3680  without regard to whether a judgment of conviction has been
 3681  entered by the court having jurisdiction of such cases;
 3682         (c) Have her or his fingerprints on file with the
 3683  department or with an agency designated by the department;
 3684         (d) Have good moral character as determined by the
 3685  department;
 3686         (e) Be at least 18 years of age;
 3687         (f) Have satisfactorily completed the firesafety inspector
 3688  certification examination as prescribed by the department; and
 3689         (g)1. Have satisfactorily completed, as determined by the
 3690  department, a firesafety inspector training program of not less
 3691  than 200 hours established by the department and administered by
 3692  agencies and institutions approved by the department for the
 3693  purpose of providing basic certification training for firesafety
 3694  inspectors; or
 3695         2. Have received in another state training which is
 3696  determined by the department to be at least equivalent to that
 3697  required by the department for approved firesafety inspector
 3698  education and training programs in this state.
 3699         (3) Each special state firesafety inspection which is
 3700  required by law and is conducted by or on behalf of an agency of
 3701  the state must be performed by an individual who has met the
 3702  provision of subsection (2), except that the duration of the
 3703  training program shall not exceed 120 hours of specific training
 3704  for the type of property that such special state firesafety
 3705  inspectors are assigned to inspect.
 3706         (4) A firefighter certified pursuant to s. 633.35 may
 3707  conduct firesafety inspections, under the supervision of a
 3708  certified firesafety inspector, while on duty as a member of a
 3709  fire department company conducting inservice firesafety
 3710  inspections without being certified as a firesafety inspector,
 3711  if such firefighter has satisfactorily completed an inservice
 3712  fire department company inspector training program of at least
 3713  24 hours’ duration as provided by rule of the department.
 3714         (5) Every firesafety inspector or special state firesafety
 3715  inspector certificate is valid for a period of 3 years from the
 3716  date of issuance. Renewal of certification shall be subject to
 3717  the affected person’s completing proper application for renewal
 3718  and meeting all of the requirements for renewal as established
 3719  under this chapter or by rule promulgated thereunder, which
 3720  shall include completion of at least 40 hours during the
 3721  preceding 3-year period of continuing education as required by
 3722  the rule of the department or, in lieu thereof, successful
 3723  passage of an examination as established by the department.
 3724         (6) The State Fire Marshal may deny, refuse to renew,
 3725  suspend, or revoke the certificate of a firesafety inspector or
 3726  special state firesafety inspector if it finds that any of the
 3727  following grounds exist:
 3728         (a) Any cause for which issuance of a certificate could
 3729  have been refused had it then existed and been known to the
 3730  State Fire Marshal.
 3731         (b) Violation of this chapter or any rule or order of the
 3732  State Fire Marshal.
 3733         (c) Falsification of records relating to the certificate.
 3734         (d) Having been found guilty of or having pleaded guilty or
 3735  nolo contendere to a felony, whether or not a judgment of
 3736  conviction has been entered.
 3737         (e) Failure to meet any of the renewal requirements.
 3738         (f) Having been convicted of a crime in any jurisdiction
 3739  which directly relates to the practice of fire code inspection,
 3740  plan review, or administration.
 3741         (g) Making or filing a report or record that the
 3742  certificateholder knows to be false, or knowingly inducing
 3743  another to file a false report or record, or knowingly failing
 3744  to file a report or record required by state or local law, or
 3745  knowingly impeding or obstructing such filing, or knowingly
 3746  inducing another person to impede or obstruct such filing.
 3747         (h) Failing to properly enforce applicable fire codes or
 3748  permit requirements within this state which the
 3749  certificateholder knows are applicable by committing willful
 3750  misconduct, gross negligence, gross misconduct, repeated
 3751  negligence, or negligence resulting in a significant danger to
 3752  life or property.
 3753         (i) Accepting labor, services, or materials at no charge or
 3754  at a noncompetitive rate from any person who performs work that
 3755  is under the enforcement authority of the certificateholder and
 3756  who is not an immediate family member of the certificateholder.
 3757  For the purpose of this paragraph, the term “immediate family
 3758  member” means a spouse, child, parent, sibling, grandparent,
 3759  aunt, uncle, or first cousin of the person or the person’s
 3760  spouse or any person who resides in the primary residence of the
 3761  certificateholder.
 3762         (7) The department shall provide by rule for the
 3763  certification of firesafety inspectors.
 3764         Section 97. Subsection (12) of section 641.495, Florida
 3765  Statutes, is amended to read:
 3766         641.495 Requirements for issuance and maintenance of
 3767  certificate.—
 3768         (12) The provisions of part I of chapter 395 do not apply
 3769  to a health maintenance organization that, on or before January
 3770  1, 1991, provides not more than 10 outpatient holding beds for
 3771  short-term and hospice-type patients in an ambulatory care
 3772  facility for its members, provided that such health maintenance
 3773  organization maintains current accreditation by The Joint
 3774  Commission on Accreditation of Health Care Organizations, the
 3775  Accreditation Association for Ambulatory Health Care, or the
 3776  National Committee for Quality Assurance.
 3777         Section 98. Subsection (13) of section 651.118, Florida
 3778  Statutes, is amended to read:
 3779         651.118 Agency for Health Care Administration; certificates
 3780  of need; sheltered beds; community beds.—
 3781         (13) Residents, as defined in this chapter, are not
 3782  considered new admissions for the purpose of s.
 3783  400.141(1)(n)(o)1.d.
 3784         Section 99. Subsection (2) of section 766.1015, Florida
 3785  Statutes, is amended to read:
 3786         766.1015 Civil immunity for members of or consultants to
 3787  certain boards, committees, or other entities.—
 3788         (2) Such committee, board, group, commission, or other
 3789  entity must be established in accordance with state law or in
 3790  accordance with requirements of The Joint Commission on
 3791  Accreditation of Healthcare Organizations, established and duly
 3792  constituted by one or more public or licensed private hospitals
 3793  or behavioral health agencies, or established by a governmental
 3794  agency. To be protected by this section, the act, decision,
 3795  omission, or utterance may not be made or done in bad faith or
 3796  with malicious intent.
 3797         Section 100. Subsection (4) of section 766.202, Florida
 3798  Statutes, is amended to read:
 3799         766.202 Definitions; ss. 766.201-766.212.—As used in ss.
 3800  766.201-766.212, the term:
 3801         (4) “Health care provider” means any hospital, ambulatory
 3802  surgical center, or mobile surgical facility as defined and
 3803  licensed under chapter 395; a birth center licensed under
 3804  chapter 383; any person licensed under chapter 458, chapter 459,
 3805  chapter 460, chapter 461, chapter 462, chapter 463, part I of
 3806  chapter 464, chapter 466, chapter 467, part XIV of chapter 468,
 3807  or chapter 486; a clinical lab licensed under chapter 483; a
 3808  health maintenance organization certificated under part I of
 3809  chapter 641; a blood bank; a plasma center; an industrial
 3810  clinic; a renal dialysis facility; or a professional association
 3811  partnership, corporation, joint venture, or other association
 3812  for professional activity by health care providers.
 3813         Section 101. This act shall take effect July 1, 2010.

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