November 26, 2020
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       Florida Senate - 2010                             CS for SB 2434
       
       
       
       By the Committee on Health Regulation; and Senator Gardiner
       
       
       
       
       588-04753A-10                                         20102434c1
    1                        A bill to be entitled                      
    2         An act relating to the reduction and simplification of
    3         health care provider regulation; amending s. 112.0455,
    4         F.S., relating to the Drug-Free Workplace Act;
    5         deleting an obsolete provision; amending s. 318.21,
    6         F.S.; revising distribution of funds from civil
    7         penalties imposed for traffic infractions by county
    8         courts; amending s. 381.00315, F.S.; directing the
    9         Department of Health to accept funds from counties,
   10         municipalities, and certain other entities for the
   11         purchase of certain products made available under a
   12         contract of the United States Department of Health and
   13         Human Services for the manufacture and delivery of
   14         such products in response to a public health
   15         emergency; amending s. 381.0072, F.S.; limiting
   16         Department of Health food service inspections in
   17         nursing homes; requiring the department to coordinate
   18         inspections with the Agency for Health Care
   19         Administration; amending s. 381.06014, F.S.; defining
   20         the term “volunteer donor”; requiring that certain
   21         blood establishments disclose specified information on
   22         the Internet; repealing s. 383.325, F.S., relating to
   23         confidentiality of inspection reports of licensed
   24         birth center facilities; amending s. 395.002, F.S.;
   25         revising and deleting definitions applicable to
   26         regulation of hospitals and other licensed facilities;
   27         conforming a cross-reference; amending s. 395.003,
   28         F.S.; deleting an obsolete provision; conforming a
   29         cross-reference; amending s. 395.0193, F.S.; requiring
   30         a licensed facility to report certain peer review
   31         information and final disciplinary actions to the
   32         Division of Medical Quality Assurance of the
   33         Department of Health rather than the Division of
   34         Health Quality Assurance of the Agency for Health Care
   35         Administration; amending s. 395.1023, F.S.; providing
   36         for the Department of Children and Family Services
   37         rather than the Department of Health to perform
   38         certain functions with respect to child protection
   39         cases; requiring certain hospitals to notify the
   40         Department of Children and Family Services of
   41         compliance; amending s. 395.1041, F.S., relating to
   42         hospital emergency services and care; deleting
   43         obsolete provisions; repealing s. 395.1046, F.S.,
   44         relating to complaint investigation procedures;
   45         amending s. 395.1055, F.S.; requiring licensed
   46         facility beds to conform to standards specified by the
   47         Agency for Health Care Administration, the Florida
   48         Building Code, and the Florida Fire Prevention Code;
   49         amending s. 395.10972, F.S.; revising a reference to
   50         the Florida Society of Healthcare Risk Management to
   51         conform to the current designation; amending s.
   52         395.2050, F.S.; revising a reference to the federal
   53         Health Care Financing Administration to conform to the
   54         current designation; amending s. 395.3036, F.S.;
   55         correcting a reference; repealing s. 395.3037, F.S.,
   56         relating to redundant definitions; amending ss.
   57         154.11, 394.741, 395.3038, 400.925, 400.9935, 408.05,
   58         440.13, 627.645, 627.668, 627.669, 627.736, 641.495,
   59         and 766.1015, F.S.; revising references to the Joint
   60         Commission on Accreditation of Healthcare
   61         Organizations, the Commission on Accreditation of
   62         Rehabilitation Facilities, and the Council on
   63         Accreditation to conform to their current
   64         designations; amending s. 395.602, F.S.; revising the
   65         definition of the term “rural hospital” to delete an
   66         obsolete provision; amending s. 400.021, F.S.;
   67         revising the definition of the term “geriatric
   68         outpatient clinic”; amending s. 400.0255, F.S.;
   69         correcting an obsolete cross-reference to
   70         administrative rules; amending s. 400.063, F.S.;
   71         deleting an obsolete provision; amending ss. 400.071
   72         and 400.0712, F.S.; revising applicability of general
   73         licensure requirements under part II of ch. 408, F.S.,
   74         to applications for nursing home licensure; revising
   75         provisions governing inactive licenses; amending s.
   76         400.111, F.S.; providing for disclosure of controlling
   77         interest of a nursing home facility upon request by
   78         the Agency for Health Care Administration; amending s.
   79         400.1183, F.S.; revising grievance record maintenance
   80         and reporting requirements for nursing homes; amending
   81         s. 400.141, F.S.; providing criteria for the provision
   82         of respite services by nursing homes; requiring a
   83         written plan of care; requiring a contract for
   84         services; requiring resident release to caregivers to
   85         be designated in writing; providing an exemption to
   86         the application of discharge planning rules; providing
   87         for residents’ rights; providing for use of personal
   88         medications; providing terms of respite stay;
   89         providing for communication of patient information;
   90         requiring a physician order for care and proof of a
   91         physical examination; providing for services for
   92         respite patients and duties of facilities with respect
   93         to such patients; conforming a cross-reference;
   94         requiring facilities to maintain clinical records that
   95         meet specified standards; providing a fine relating to
   96         an admissions moratorium; deleting requirement for
   97         facilities to submit certain information related to
   98         management companies to the agency; deleting a
   99         requirement for facilities to notify the agency of
  100         certain bankruptcy filings to conform to changes made
  101         by the act; amending s. 400.142, F.S.; deleting
  102         language relating to agency adoption of rules;
  103         amending 400.147, F.S.; revising reporting
  104         requirements for licensed nursing home facilities
  105         relating to adverse incidents; repealing s. 400.148,
  106         F.S., relating to the Medicaid “Up-or-Out” Quality of
  107         Care Contract Management Program; amending s. 400.162,
  108         F.S., requiring nursing homes to provide a resident
  109         property statement annually and upon request; amending
  110         s. 400.179, F.S.; revising requirements for nursing
  111         home lease bond alternative fees; deleting an obsolete
  112         provision; amending s. 400.19, F.S.; revising
  113         inspection requirements; repealing s. 400.195, F.S.,
  114         relating to agency reporting requirements; amending s.
  115         400.23, F.S.; deleting an obsolete provision;
  116         correcting a reference; directing the agency to adopt
  117         rules for minimum staffing standards in nursing homes
  118         that serve persons under 21 years of age; providing
  119         minimum staffing standards; amending s. 400.275, F.S.;
  120         revising agency duties with regard to training nursing
  121         home surveyor teams; revising requirements for team
  122         members; amending s. 400.484, F.S.; revising the
  123         schedule of home health agency inspection violations;
  124         amending s. 400.606, F.S.; revising the content
  125         requirements of the plan accompanying an initial or
  126         change-of-ownership application for licensure of a
  127         hospice; revising requirements relating to
  128         certificates of need for certain hospice facilities;
  129         amending s. 400.607, F.S.; revising grounds for agency
  130         action against a hospice; amending s. 400.915, F.S.;
  131         correcting an obsolete cross-reference to
  132         administrative rules; amending s. 400.931, F.S.;
  133         deleting a requirement that an applicant for a home
  134         medical equipment provider license submit a surety
  135         bond to the agency; amending s. 400.932, F.S.;
  136         revising grounds for the imposition of administrative
  137         penalties for certain violations by an employee of a
  138         home medical equipment provider; amending s. 400.967,
  139         F.S.; revising the schedule of inspection violations
  140         for intermediate care facilities for the
  141         developmentally disabled; providing a penalty for
  142         certain violations; amending s. 400.9905, F.S.;
  143         providing that part X of ch, 400, F.S., the Health
  144         Care Clinic Act, does not apply to an entity owned by
  145         a corporation with a specified amount of annual sales
  146         of health care services under certain circumstances or
  147         to an entity owned or controlled by a publicly traded
  148         entity with a specified amount of annual revenues;
  149         amending s. 400.991, F.S.; conforming terminology;
  150         revising application requirements relating to
  151         documentation of financial ability to operate a mobile
  152         clinic; amending s. 408.034, F.S.; revising agency
  153         authority relating to licensing of intermediate care
  154         facilities for the developmentally disabled; amending
  155         s. 408.036, F.S.; deleting an exemption from certain
  156         certificate-of-need review requirements for a hospice
  157         or a hospice inpatient facility; amending s. 408.043,
  158         F.S.; revising requirements for certain freestanding
  159         inpatient hospice care facilities to obtain a
  160         certificate of need; amending s. 408.061, F.S.;
  161         revising health care facility data reporting
  162         requirements; amending s. 408.10, F.S.; removing
  163         agency authority to investigate certain consumer
  164         complaints; amending s. 408.802, F.S.; removing
  165         applicability of part II of ch. 408, F.S., relating to
  166         general licensure requirements, to private review
  167         agents; amending s. 408.804, F.S.; providing penalties
  168         for altering, defacing, or falsifying a license
  169         certificate issued by the agency or displaying such an
  170         altered, defaced, or falsified certificate; amending
  171         s. 408.806, F.S.; revising agency responsibilities for
  172         notification of licensees of impending expiration of a
  173         license; requiring payment of a late fee for a license
  174         application to be considered complete under certain
  175         circumstances; amending s. 408.810, F.S.; revising
  176         provisions relating to information required for
  177         licensure; requiring proof of submission of notice to
  178         a mortgagor or landlord regarding provision of
  179         services requiring licensure; requiring disclosure of
  180         information by a controlling interest of certain court
  181         actions relating to financial instability within a
  182         specified time period; amending s. 408.813, F.S.;
  183         authorizing the agency to impose fines for
  184         unclassified violations of part II of ch. 408, F.S.;
  185         amending s. 408.815, F.S.; authorizing the agency to
  186         extend a license expiration date under certain
  187         circumstances; amending s. 409.221, F.S.; deleting a
  188         reporting requirement relating to the consumer
  189         directed care program; amending s. 409.91196, F.S.;
  190         conforming a cross-reference; amending s. 409.912,
  191         F.S.; revising procedures for implementation of a
  192         Medicaid prescribed-drug spending-control program;
  193         amending s. 429.07, F.S.; deleting the requirement for
  194         an assisted living facility to obtain an additional
  195         license in order to provide limited nursing services;
  196         deleting the requirement for the agency to conduct
  197         quarterly monitoring visits of facilities that hold a
  198         license to provide extended congregate care services;
  199         deleting the requirement for the department to report
  200         annually on the status of and recommendations related
  201         to extended congregate care; deleting the requirement
  202         for the agency to conduct monitoring visits at least
  203         twice a year to facilities providing limited nursing
  204         services; increasing the licensure fees and the
  205         maximum fee required for the standard license;
  206         increasing the licensure fees for the extended
  207         congregate care license; eliminating the license fee
  208         for the limited nursing services license; transferring
  209         from another provision of law the requirement that a
  210         biennial survey of an assisted living facility include
  211         specific actions to determine whether the facility is
  212         adequately protecting residents’ rights; providing
  213         that an assisted living facility that has a class I or
  214         class II violation is subject to monitoring visits;
  215         requiring a registered nurse to participate in certain
  216         monitoring visits; amending s. 429.11, F.S.; revising
  217         licensure application requirements for assisted living
  218         facilities to eliminate provisional licenses; amending
  219         s. 429.12, F.S.; revising notification requirements
  220         for the sale or transfer of ownership of an assisted
  221         living facility; amending s. 429.14, F.S.; removing a
  222         ground for the imposition of an administrative
  223         penalty; clarifying provisions relating to a
  224         facility’s request for a hearing under certain
  225         circumstances; authorizing the agency to provide
  226         certain information relating to the licensure status
  227         of assisted living facilities electronically or
  228         through the agency’s Internet website; amending s.
  229         429.17, F.S.; deleting provisions relating to the
  230         limited nursing services license; revising agency
  231         responsibilities regarding the issuance of conditional
  232         licenses; amending s. 429.19, F.S.; clarifying that a
  233         monitoring fee may be assessed in addition to an
  234         administrative fine; amending s. 429.23, F.S.;
  235         deleting reporting requirements for assisted living
  236         facilities relating to liability claims; amending s.
  237         429.255, F.S.; eliminating provisions authorizing the
  238         use of volunteers to provide certain health-care
  239         related services in assisted living facilities;
  240         authorizing assisted living facilities to provide
  241         limited nursing services; requiring an assisted living
  242         facility to be responsible for certain recordkeeping
  243         and staff to be trained to monitor residents receiving
  244         certain health-care-related services; amending s.
  245         429.28, F.S.; deleting a requirement for a biennial
  246         survey of an assisted living facility, to conform to
  247         changes made by the act; amending s. 429.35, F.S.;
  248         authorizing the agency to provide certain information
  249         relating to the inspections of assisted living
  250         facilities electronically or through the agency’s
  251         Internet website; amending s. 429.41, F.S., relating
  252         to rulemaking; conforming provisions to changes made
  253         by the act; amending s. 429.53, F.S.; revising
  254         provisions relating to consultation by the agency;
  255         revising a definition; amending s. 429.54, F.S.;
  256         requiring licensed assisted living facilities to
  257         electronically report certain data semiannually to the
  258         agency in accordance with rules adopted by the
  259         department; amending s. 429.71, F.S.; revising
  260         schedule of inspection violations for adult family
  261         care homes; amending s. 429.911, F.S.; deleting a
  262         ground for agency action against an adult day care
  263         center; amending s. 429.915, F.S.; revising agency
  264         responsibilities regarding the issuance of conditional
  265         licenses; amending s. 483.201, F.S.; providing for
  266         disciplinary action against clinical laboratories
  267         failing to disclose specified information on the
  268         Internet; providing a maximum annual administrative
  269         fine that may be imposed annually against certain
  270         clinical laboratories for failure to comply with such
  271         disclosure requirement; amending s. 483.294, F.S.;
  272         revising frequency of agency inspections of
  273         multiphasic health testing centers; amending s.
  274         499.003, F.S.; revising the definition of the term
  275         “health care entity” to clarify that a blood
  276         establishment may be a health care entity and engage
  277         in certain activities; removing a requirement that
  278         certain prescription drug purchasers maintain a
  279         separate inventory of certain prescription drugs;
  280         amending s. 499.005, F.S.; clarifying provisions
  281         prohibiting the unauthorized wholesale distribution of
  282         a prescription drug that was purchased by a hospital
  283         or other health care entity, to conform to changes
  284         made by the act; amending s. 499.01, F.S.; exempting
  285         certain blood establishments from the requirements to
  286         be permitted as a prescription drug manufacturer and
  287         register products; requiring that certain blood
  288         establishments obtain a restricted prescription drug
  289         distributor permit under specified conditions;
  290         limiting the prescription drugs that a blood
  291         establishment may distribute with the restricted
  292         prescription drug distributor permit; authorizing the
  293         Department of Health to adopt rules; amending s.
  294         499.01212, F.S.; exempting prescription drugs
  295         contained in sealed medical convenience kits from the
  296         pedigree paper requirements under specified
  297         circumstances; amending s. 633.081, F.S.; limiting
  298         Fire Marshal inspections of nursing homes to once a
  299         year; providing for additional inspections based on
  300         complaints and violations identified in the course of
  301         orientation or training activities; amending s.
  302         766.202, F.S.; adding persons licensed under part XIV
  303         of ch. 468, F.S., to the definition of “health care
  304         provider”; amending ss. 394.4787, 400.0239, 408.07,
  305         430.80, and 651.118, F.S.; conforming terminology and
  306         cross-references; revising a reference; providing an
  307         effective date.
  308  
  309  Be It Enacted by the Legislature of the State of Florida:
  310  
  311         Section 1. Present paragraph (e) of subsection (10) and
  312  paragraph (e) of subsection (14) of section 112.0455, Florida
  313  Statutes, are amended, and paragraphs (f) through (k) of
  314  subsection (10) of that section are redesignated as paragraphs
  315  (e) through (j), respectively, to read:
  316         112.0455 Drug-Free Workplace Act.—
  317         (10) EMPLOYER PROTECTION.—
  318         (e)Nothing in this section shall be construed to operate
  319  retroactively, and nothing in this section shall abrogate the
  320  right of an employer under state law to conduct drug tests prior
  321  to January 1, 1990. A drug test conducted by an employer prior
  322  to January 1, 1990, is not subject to this section.
  323         (14) DISCIPLINE REMEDIES.—
  324         (e) Upon resolving an appeal filed pursuant to paragraph
  325  (c), and finding a violation of this section, the commission may
  326  order the following relief:
  327         1. Rescind the disciplinary action, expunge related records
  328  from the personnel file of the employee or job applicant and
  329  reinstate the employee.
  330         2. Order compliance with paragraph (10)(f)(g).
  331         3. Award back pay and benefits.
  332         4. Award the prevailing employee or job applicant the
  333  necessary costs of the appeal, reasonable attorney’s fees, and
  334  expert witness fees.
  335         Section 2. Paragraph (n) of subsection (1) of section
  336  154.11, Florida Statutes, is amended to read:
  337         154.11 Powers of board of trustees.—
  338         (1) The board of trustees of each public health trust shall
  339  be deemed to exercise a public and essential governmental
  340  function of both the state and the county and in furtherance
  341  thereof it shall, subject to limitation by the governing body of
  342  the county in which such board is located, have all of the
  343  powers necessary or convenient to carry out the operation and
  344  governance of designated health care facilities, including, but
  345  without limiting the generality of, the foregoing:
  346         (n) To appoint originally the staff of physicians to
  347  practice in any designated facility owned or operated by the
  348  board and to approve the bylaws and rules to be adopted by the
  349  medical staff of any designated facility owned and operated by
  350  the board, such governing regulations to be in accordance with
  351  the standards of The Joint Commission on the Accreditation of
  352  Hospitals which provide, among other things, for the method of
  353  appointing additional staff members and for the removal of staff
  354  members.
  355         Section 3. Subsection (15) of section 318.21, Florida
  356  Statutes, is amended to read:
  357         318.21 Disposition of civil penalties by county courts.—All
  358  civil penalties received by a county court pursuant to the
  359  provisions of this chapter shall be distributed and paid monthly
  360  as follows:
  361         (15) Of the additional fine assessed under s. 318.18(3)(e)
  362  for a violation of s. 316.1893, 50 percent of the moneys
  363  received from the fines shall be remitted to the Department of
  364  Revenue and deposited into the Brain and Spinal Cord Injury
  365  Trust Fund of Department of Health and shall be appropriated to
  366  the Department of Health Agency for Health Care Administration
  367  as general revenue to provide an enhanced Medicaid payment to
  368  nursing homes that serve Medicaid recipients with spinal cord
  369  injuries that are medically complex and who are technologically
  370  and respiratory dependent with brain and spinal cord injuries.
  371  The remaining 50 percent of the moneys received from the
  372  enhanced fine imposed under s. 318.18(3)(e) shall be remitted to
  373  the Department of Revenue and deposited into the Department of
  374  Health Administrative Trust Fund to provide financial support to
  375  certified trauma centers in the counties where enhanced penalty
  376  zones are established to ensure the availability and
  377  accessibility of trauma services. Funds deposited into the
  378  Administrative Trust Fund under this subsection shall be
  379  allocated as follows:
  380         (a) Fifty percent shall be allocated equally among all
  381  Level I, Level II, and pediatric trauma centers in recognition
  382  of readiness costs for maintaining trauma services.
  383         (b) Fifty percent shall be allocated among Level I, Level
  384  II, and pediatric trauma centers based on each center’s relative
  385  volume of trauma cases as reported in the Department of Health
  386  Trauma Registry.
  387         Section 4. Subsection (3) is added to section 381.00315,
  388  Florida Statutes, to read:
  389         381.00315 Public health advisories; public health
  390  emergencies.—The State Health Officer is responsible for
  391  declaring public health emergencies and issuing public health
  392  advisories.
  393         (3)To facilitate effective emergency management, when the
  394  United States Department of Health and Human Services contracts
  395  for the manufacture and delivery of licensable products in
  396  response to a public health emergency and the terms of those
  397  contracts are made available to the states, the department shall
  398  accept funds provided by counties, municipalities, and other
  399  entities designated in the state emergency management plan
  400  required under s. 252.35(2)(a) for the purpose of participation
  401  in such contracts. The department shall deposit the funds into
  402  the Grants and Donations Trust Fund and expend the funds on
  403  behalf of the donor county, municipality, or other entity for
  404  the purchase the licensable products made available under the
  405  contract.
  406         Section 5. Paragraph (e) is added to subsection (2) of
  407  section 381.0072, Florida Statutes, to read:
  408         381.0072 Food service protection.—It shall be the duty of
  409  the Department of Health to adopt and enforce sanitation rules
  410  consistent with law to ensure the protection of the public from
  411  food-borne illness. These rules shall provide the standards and
  412  requirements for the storage, preparation, serving, or display
  413  of food in food service establishments as defined in this
  414  section and which are not permitted or licensed under chapter
  415  500 or chapter 509.
  416         (2) DUTIES.—
  417         (e)The department shall inspect food service
  418  establishments in nursing homes licensed under part II of
  419  chapter 400 twice each year. The department may make additional
  420  inspections only in response to complaints. The department shall
  421  coordinate inspections with the Agency for Health Care
  422  Administration, such that the department’s inspection is at
  423  least 60 days after a recertification visit by the Agency for
  424  Health Care Administration.
  425         Section 6. Section 381.06014, Florida Statutes, is amended
  426  to read:
  427         381.06014 Blood establishments.—
  428         (1) As used in this section, the term:
  429         (a) “Blood establishment” means any person, entity, or
  430  organization, operating within the state, which examines an
  431  individual for the purpose of blood donation or which collects,
  432  processes, stores, tests, or distributes blood or blood
  433  components collected from the human body for the purpose of
  434  transfusion, for any other medical purpose, or for the
  435  production of any biological product.
  436         (b) “Volunteer donor” means a person who does not receive
  437  remuneration, other than an incentive, for a blood donation
  438  intended for transfusion, and the product container of the
  439  donation from the person qualifies for labeling with the
  440  statement “volunteer donor” under 21 C.F.R. 606.121.
  441         (2) Any blood establishment operating in the state may not
  442  conduct any activity defined in subsection (1) unless that blood
  443  establishment is operated in a manner consistent with the
  444  provisions of Title 21 parts 211 and 600-640, Code of Federal
  445  Regulations.
  446         (3) Any blood establishment determined to be operating in
  447  the state in a manner not consistent with the provisions of
  448  Title 21 parts 211 and 600-640, Code of Federal Regulations, and
  449  in a manner that constitutes a danger to the health or well
  450  being of donors or recipients as evidenced by the federal Food
  451  and Drug Administration’s inspection reports and the revocation
  452  of the blood establishment’s license or registration shall be in
  453  violation of this chapter and shall immediately cease all
  454  operations in the state.
  455         (4) The operation of a blood establishment in a manner not
  456  consistent with the provisions of Title 21 parts 211 and 600
  457  640, Code of Federal Regulations, and in a manner that
  458  constitutes a danger to the health or well-being of blood donors
  459  or recipients as evidenced by the federal Food and Drug
  460  Administration’s inspection process is declared a nuisance and
  461  inimical to the public health, welfare, and safety. The Agency
  462  for Health Care Administration or any state attorney may bring
  463  an action for an injunction to restrain such operations or
  464  enjoin the future operation of the blood establishment.
  465         (5) A blood establishment that collects blood or blood
  466  components from volunteer donors must disclose on the Internet
  467  information to educate and inform donors and the public about
  468  the blood establishment’s activities. A hospital that collects
  469  blood or blood components from volunteer donors for its own use
  470  or for health care providers that are part of its business
  471  entity is exempt from the disclosure requirements in this
  472  subsection. The information required to be disclosed under this
  473  subsection may be cumulative for all blood establishments within
  474  a business entity. Disciplinary action against the blood
  475  establishment’s clinical laboratory license may be taken as
  476  provided in s. 483.201 for a blood establishment that is
  477  required to disclose but fails to disclose on its website all of
  478  the following information:
  479         (a) A description of the steps involved in collecting,
  480  processing, and distributing volunteer donations, presented in a
  481  manner appropriate for the donating public.
  482         (b) By March 1 of each year, the number of units of blood
  483  components, identified by component, that were:
  484         1. Produced by the blood establishment during the preceding
  485  calendar year;
  486         2. Obtained from other sources during the preceding
  487  calendar year;
  488         3. Distributed during the preceding year to health care
  489  providers located outside this state. However, if the blood
  490  establishment collects donations in a county outside this state,
  491  distributions to health care providers in that county shall be
  492  excluded. Such information shall be aggregated by health care
  493  providers located within the United States and its territories
  494  or outside the United States and its territories; and
  495         4. Distributed to entities that are not health care
  496  providers during the preceding year. Such information shall be
  497  aggregated by purchasers located within the United States and
  498  its territories or outside the United States and its
  499  territories.
  500  
  501  For purposes of this paragraph, the components that must be
  502  reported include whole blood, red blood cells, leukoreduced red
  503  blood cells, fresh frozen plasma or the equivalent, recovered
  504  plasma, platelets, and cryoprecipitated antihemophilic factor.
  505         (c) The blood establishment’s conflict-of-interest policy,
  506  policy concerning related-party transactions, whistleblower
  507  policy, and policy for determining executive compensation. If a
  508  change to any of these documents occurs, the revised document
  509  must be available on the blood establishment’s website by the
  510  following March 1.
  511         (d)1. The most recent 3 years of the Return of Organization
  512  Exempt from Income Tax, Internal Revenue Service Form 990, if
  513  the business entity for the blood establishment is eligible to
  514  file such return. The Form 990 must be available on the blood
  515  establishment’s website within 30 calendar days after filing it
  516  with the Internal Revenue Service; or
  517         2. If the business entity for the blood establishment is
  518  not eligible to file the Form 990 return, a balance sheet,
  519  income statement, statement of changes in cash flow, and the
  520  expression of an opinion thereon by an independent certified
  521  public accountant who audited or reviewed such financial
  522  statements. Such documents must be available on the blood
  523  establishment’s website within 120 days after the end of the
  524  blood establishment’s fiscal year and must remain on the blood
  525  establishment’s website for at least 36 months.
  526         Section 7. Section 383.325, Florida Statutes, is repealed.
  527         Section 8. Subsection (7) of section 394.4787, Florida
  528  Statutes, is amended to read:
  529         394.4787 Definitions; ss. 394.4786, 394.4787, 394.4788, and
  530  394.4789.—As used in this section and ss. 394.4786, 394.4788,
  531  and 394.4789:
  532         (7) “Specialty psychiatric hospital” means a hospital
  533  licensed by the agency pursuant to s. 395.002(26)(28) and part
  534  II of chapter 408 as a specialty psychiatric hospital.
  535         Section 9. Subsection (2) of section 394.741, Florida
  536  Statutes, is amended to read:
  537         394.741 Accreditation requirements for providers of
  538  behavioral health care services.—
  539         (2) Notwithstanding any provision of law to the contrary,
  540  accreditation shall be accepted by the agency and department in
  541  lieu of the agency’s and department’s facility licensure onsite
  542  review requirements and shall be accepted as a substitute for
  543  the department’s administrative and program monitoring
  544  requirements, except as required by subsections (3) and (4),
  545  for:
  546         (a) Any organization from which the department purchases
  547  behavioral health care services that is accredited by The Joint
  548  Commission on Accreditation of Healthcare Organizations or the
  549  Council on Accreditation for Children and Family Services, or
  550  has those services that are being purchased by the department
  551  accredited by the Commission on Accreditation of Rehabilitation
  552  Facilities CARF—the Rehabilitation Accreditation Commission.
  553         (b) Any mental health facility licensed by the agency or
  554  any substance abuse component licensed by the department that is
  555  accredited by The Joint Commission on Accreditation of
  556  Healthcare Organizations, the Commission on Accreditation of
  557  Rehabilitation Facilities CARF—the Rehabilitation Accreditation
  558  Commission, or the Council on Accreditation of Children and
  559  Family Services.
  560         (c) Any network of providers from which the department or
  561  the agency purchases behavioral health care services accredited
  562  by The Joint Commission on Accreditation of Healthcare
  563  Organizations, the Commission on Accreditation of Rehabilitation
  564  Facilities CARF—the Rehabilitation Accreditation Commission, the
  565  Council on Accreditation of Children and Family Services, or the
  566  National Committee for Quality Assurance. A provider
  567  organization, which is part of an accredited network, is
  568  afforded the same rights under this part.
  569         Section 10. Present subsections (15) through (32) of
  570  section 395.002, Florida Statutes, are renumbered as subsections
  571  (14) through (28), respectively, and present subsections (1),
  572  (14), (24), (30), and (31), and paragraph (c) of present
  573  subsection (28) of that section are amended to read:
  574         395.002 Definitions.—As used in this chapter:
  575         (1) “Accrediting organizations” means nationally recognized
  576  or approved accrediting organizations whose standards
  577  incorporate comparable licensure requirements as determined by
  578  the agency the Joint Commission on Accreditation of Healthcare
  579  Organizations, the American Osteopathic Association, the
  580  Commission on Accreditation of Rehabilitation Facilities, and
  581  the Accreditation Association for Ambulatory Health Care, Inc.
  582         (14)“Initial denial determination” means a determination
  583  by a private review agent that the health care services
  584  furnished or proposed to be furnished to a patient are
  585  inappropriate, not medically necessary, or not reasonable.
  586         (24)“Private review agent” means any person or entity
  587  which performs utilization review services for third-party
  588  payors on a contractual basis for outpatient or inpatient
  589  services. However, the term shall not include full-time
  590  employees, personnel, or staff of health insurers, health
  591  maintenance organizations, or hospitals, or wholly owned
  592  subsidiaries thereof or affiliates under common ownership, when
  593  performing utilization review for their respective hospitals,
  594  health maintenance organizations, or insureds of the same
  595  insurance group. For this purpose, health insurers, health
  596  maintenance organizations, and hospitals, or wholly owned
  597  subsidiaries thereof or affiliates under common ownership,
  598  include such entities engaged as administrators of self
  599  insurance as defined in s. 624.031.
  600         (26)(28) “Specialty hospital” means any facility which
  601  meets the provisions of subsection (12), and which regularly
  602  makes available either:
  603         (c) Intensive residential treatment programs for children
  604  and adolescents as defined in subsection (14) (15).
  605         (30)“Utilization review” means a system for reviewing the
  606  medical necessity or appropriateness in the allocation of health
  607  care resources of hospital services given or proposed to be
  608  given to a patient or group of patients.
  609         (31)“Utilization review plan” means a description of the
  610  policies and procedures governing utilization review activities
  611  performed by a private review agent.
  612         Section 11. Paragraph (c) of subsection (1) and paragraph
  613  (b) of subsection (2) of section 395.003, Florida Statutes, are
  614  amended to read:
  615         395.003 Licensure; denial, suspension, and revocation.—
  616         (1)
  617         (c)Until July 1, 2006, additional emergency departments
  618  located off the premises of licensed hospitals may not be
  619  authorized by the agency.
  620         (2)
  621         (b) The agency shall, at the request of a licensee that is
  622  a teaching hospital as defined in s. 408.07(45), issue a single
  623  license to a licensee for facilities that have been previously
  624  licensed as separate premises, provided such separately licensed
  625  facilities, taken together, constitute the same premises as
  626  defined in s. 395.002(22)(23). Such license for the single
  627  premises shall include all of the beds, services, and programs
  628  that were previously included on the licenses for the separate
  629  premises. The granting of a single license under this paragraph
  630  shall not in any manner reduce the number of beds, services, or
  631  programs operated by the licensee.
  632         Section 12. Paragraph (e) of subsection (2) and subsection
  633  (4) of section 395.0193, Florida Statutes, are amended to read:
  634         395.0193 Licensed facilities; peer review; disciplinary
  635  powers; agency or partnership with physicians.—
  636         (2) Each licensed facility, as a condition of licensure,
  637  shall provide for peer review of physicians who deliver health
  638  care services at the facility. Each licensed facility shall
  639  develop written, binding procedures by which such peer review
  640  shall be conducted. Such procedures shall include:
  641         (e) Recording of agendas and minutes which do not contain
  642  confidential material, for review by the Division of Medical
  643  Quality Assurance of the department Health Quality Assurance of
  644  the agency.
  645         (4) Pursuant to ss. 458.337 and 459.016, any disciplinary
  646  actions taken under subsection (3) shall be reported in writing
  647  to the Division of Medical Quality Assurance of the department
  648  Health Quality Assurance of the agency within 30 working days
  649  after its initial occurrence, regardless of the pendency of
  650  appeals to the governing board of the hospital. The notification
  651  shall identify the disciplined practitioner, the action taken,
  652  and the reason for such action. All final disciplinary actions
  653  taken under subsection (3), if different from those which were
  654  reported to the department agency within 30 days after the
  655  initial occurrence, shall be reported within 10 working days to
  656  the Division of Medical Quality Assurance of the department
  657  Health Quality Assurance of the agency in writing and shall
  658  specify the disciplinary action taken and the specific grounds
  659  therefor. The division shall review each report and determine
  660  whether it potentially involved conduct by the licensee that is
  661  subject to disciplinary action, in which case s. 456.073 shall
  662  apply. The reports are not subject to inspection under s.
  663  119.07(1) even if the division’s investigation results in a
  664  finding of probable cause.
  665         Section 13. Section 395.1023, Florida Statutes, is amended
  666  to read:
  667         395.1023 Child abuse and neglect cases; duties.—Each
  668  licensed facility shall adopt a protocol that, at a minimum,
  669  requires the facility to:
  670         (1) Incorporate a facility policy that every staff member
  671  has an affirmative duty to report, pursuant to chapter 39, any
  672  actual or suspected case of child abuse, abandonment, or
  673  neglect; and
  674         (2) In any case involving suspected child abuse,
  675  abandonment, or neglect, designate, at the request of the
  676  Department of Children and Family Services, a staff physician to
  677  act as a liaison between the hospital and the Department of
  678  Children and Family Services office which is investigating the
  679  suspected abuse, abandonment, or neglect, and the child
  680  protection team, as defined in s. 39.01, when the case is
  681  referred to such a team.
  682  
  683  Each general hospital and appropriate specialty hospital shall
  684  comply with the provisions of this section and shall notify the
  685  agency and the Department of Children and Family Services of its
  686  compliance by sending a copy of its policy to the agency and the
  687  Department of Children and Family Services as required by rule.
  688  The failure by a general hospital or appropriate specialty
  689  hospital to comply shall be punished by a fine not exceeding
  690  $1,000, to be fixed, imposed, and collected by the agency. Each
  691  day in violation is considered a separate offense.
  692         Section 14. Subsection (2) and paragraph (d) of subsection
  693  (3) of section 395.1041, Florida Statutes, are amended to read:
  694         395.1041 Access to emergency services and care.—
  695         (2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency
  696  shall establish and maintain an inventory of hospitals with
  697  emergency services. The inventory shall list all services within
  698  the service capability of the hospital, and such services shall
  699  appear on the face of the hospital license. Each hospital having
  700  emergency services shall notify the agency of its service
  701  capability in the manner and form prescribed by the agency. The
  702  agency shall use the inventory to assist emergency medical
  703  services providers and others in locating appropriate emergency
  704  medical care. The inventory shall also be made available to the
  705  general public. On or before August 1, 1992, the agency shall
  706  request that each hospital identify the services which are
  707  within its service capability. On or before November 1, 1992,
  708  the agency shall notify each hospital of the service capability
  709  to be included in the inventory. The hospital has 15 days from
  710  the date of receipt to respond to the notice. By December 1,
  711  1992, the agency shall publish a final inventory. Each hospital
  712  shall reaffirm its service capability when its license is
  713  renewed and shall notify the agency of the addition of a new
  714  service or the termination of a service prior to a change in its
  715  service capability.
  716         (3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF
  717  FACILITY OR HEALTH CARE PERSONNEL.—
  718         (d)1. Every hospital shall ensure the provision of services
  719  within the service capability of the hospital, at all times,
  720  either directly or indirectly through an arrangement with
  721  another hospital, through an arrangement with one or more
  722  physicians, or as otherwise made through prior arrangements. A
  723  hospital may enter into an agreement with another hospital for
  724  purposes of meeting its service capability requirement, and
  725  appropriate compensation or other reasonable conditions may be
  726  negotiated for these backup services.
  727         2. If any arrangement requires the provision of emergency
  728  medical transportation, such arrangement must be made in
  729  consultation with the applicable provider and may not require
  730  the emergency medical service provider to provide transportation
  731  that is outside the routine service area of that provider or in
  732  a manner that impairs the ability of the emergency medical
  733  service provider to timely respond to prehospital emergency
  734  calls.
  735         3. A hospital shall not be required to ensure service
  736  capability at all times as required in subparagraph 1. if, prior
  737  to the receiving of any patient needing such service capability,
  738  such hospital has demonstrated to the agency that it lacks the
  739  ability to ensure such capability and it has exhausted all
  740  reasonable efforts to ensure such capability through backup
  741  arrangements. In reviewing a hospital’s demonstration of lack of
  742  ability to ensure service capability, the agency shall consider
  743  factors relevant to the particular case, including the
  744  following:
  745         a. Number and proximity of hospitals with the same service
  746  capability.
  747         b. Number, type, credentials, and privileges of
  748  specialists.
  749         c. Frequency of procedures.
  750         d. Size of hospital.
  751         4. The agency shall publish proposed rules implementing a
  752  reasonable exemption procedure by November 1, 1992. Subparagraph
  753  1. shall become effective upon the effective date of said rules
  754  or January 31, 1993, whichever is earlier. For a period not to
  755  exceed 1 year from the effective date of subparagraph 1., a
  756  hospital requesting an exemption shall be deemed to be exempt
  757  from offering the service until the agency initially acts to
  758  deny or grant the original request. The agency has 45 days from
  759  the date of receipt of the request to approve or deny the
  760  request. After the first year from the effective date of
  761  subparagraph 1., If the agency fails to initially act within the
  762  time period, the hospital is deemed to be exempt from offering
  763  the service until the agency initially acts to deny the request.
  764         Section 15. Section 395.1046, Florida Statutes, is
  765  repealed.
  766         Section 16. Paragraph (e) of subsection (1) of section
  767  395.1055, Florida Statutes, is amended to read:
  768         395.1055 Rules and enforcement.—
  769         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
  770  and 120.54 to implement the provisions of this part, which shall
  771  include reasonable and fair minimum standards for ensuring that:
  772         (e) Licensed facility beds conform to minimum space,
  773  equipment, and furnishings standards as specified by the agency,
  774  the Florida Building Code, and the Florida Fire Prevention Code
  775  department.
  776         Section 17. Subsection (1) of section 395.10972, Florida
  777  Statutes, is amended to read:
  778         395.10972 Health Care Risk Manager Advisory Council.—The
  779  Secretary of Health Care Administration may appoint a seven
  780  member advisory council to advise the agency on matters
  781  pertaining to health care risk managers. The members of the
  782  council shall serve at the pleasure of the secretary. The
  783  council shall designate a chair. The council shall meet at the
  784  call of the secretary or at those times as may be required by
  785  rule of the agency. The members of the advisory council shall
  786  receive no compensation for their services, but shall be
  787  reimbursed for travel expenses as provided in s. 112.061. The
  788  council shall consist of individuals representing the following
  789  areas:
  790         (1) Two shall be active health care risk managers,
  791  including one risk manager who is recommended by and a member of
  792  the Florida Society for of Healthcare Risk Management and
  793  Patient Safety.
  794         Section 18. Subsection (3) of section 395.2050, Florida
  795  Statutes, is amended to read:
  796         395.2050 Routine inquiry for organ and tissue donation;
  797  certification for procurement activities; death records review.—
  798         (3) Each organ procurement organization designated by the
  799  federal Centers for Medicare and Medicaid Services Health Care
  800  Financing Administration and licensed by the state shall conduct
  801  an annual death records review in the organ procurement
  802  organization’s affiliated donor hospitals. The organ procurement
  803  organization shall enlist the services of every Florida licensed
  804  tissue bank and eye bank affiliated with or providing service to
  805  the donor hospital and operating in the same service area to
  806  participate in the death records review.
  807         Section 19. Subsection (2) of section 395.3036, Florida
  808  Statutes, is amended to read:
  809         395.3036 Confidentiality of records and meetings of
  810  corporations that lease public hospitals or other public health
  811  care facilities.—The records of a private corporation that
  812  leases a public hospital or other public health care facility
  813  are confidential and exempt from the provisions of s. 119.07(1)
  814  and s. 24(a), Art. I of the State Constitution, and the meetings
  815  of the governing board of a private corporation are exempt from
  816  s. 286.011 and s. 24(b), Art. I of the State Constitution when
  817  the public lessor complies with the public finance
  818  accountability provisions of s. 155.40(5) with respect to the
  819  transfer of any public funds to the private lessee and when the
  820  private lessee meets at least three of the five following
  821  criteria:
  822         (2) The public lessor and the private lessee do not
  823  commingle any of their funds in any account maintained by either
  824  of them, other than the payment of the rent and administrative
  825  fees or the transfer of funds pursuant to s. 155.40(2)
  826  subsection (2).
  827         Section 20. Section 395.3037, Florida Statutes, is
  828  repealed.
  829         Section 21. Subsections (1), (4), and (5) of section
  830  395.3038, Florida Statutes, are amended to read:
  831         395.3038 State-listed primary stroke centers and
  832  comprehensive stroke centers; notification of hospitals.—
  833         (1) The agency shall make available on its website and to
  834  the department a list of the name and address of each hospital
  835  that meets the criteria for a primary stroke center and the name
  836  and address of each hospital that meets the criteria for a
  837  comprehensive stroke center. The list of primary and
  838  comprehensive stroke centers shall include only those hospitals
  839  that attest in an affidavit submitted to the agency that the
  840  hospital meets the named criteria, or those hospitals that
  841  attest in an affidavit submitted to the agency that the hospital
  842  is certified as a primary or a comprehensive stroke center by
  843  The Joint Commission on Accreditation of Healthcare
  844  Organizations.
  845         (4) The agency shall adopt by rule criteria for a primary
  846  stroke center which are substantially similar to the
  847  certification standards for primary stroke centers of The Joint
  848  Commission on Accreditation of Healthcare Organizations.
  849         (5) The agency shall adopt by rule criteria for a
  850  comprehensive stroke center. However, if The Joint Commission on
  851  Accreditation of Healthcare Organizations establishes criteria
  852  for a comprehensive stroke center, the agency shall establish
  853  criteria for a comprehensive stroke center which are
  854  substantially similar to those criteria established by The Joint
  855  Commission on Accreditation of Healthcare Organizations.
  856         Section 22. Paragraph (e) of subsection (2) of section
  857  395.602, Florida Statutes, is amended to read:
  858         395.602 Rural hospitals.—
  859         (2) DEFINITIONS.—As used in this part:
  860         (e) “Rural hospital” means an acute care hospital licensed
  861  under this chapter, having 100 or fewer licensed beds and an
  862  emergency room, which is:
  863         1. The sole provider within a county with a population
  864  density of no greater than 100 persons per square mile;
  865         2. An acute care hospital, in a county with a population
  866  density of no greater than 100 persons per square mile, which is
  867  at least 30 minutes of travel time, on normally traveled roads
  868  under normal traffic conditions, from any other acute care
  869  hospital within the same county;
  870         3. A hospital supported by a tax district or subdistrict
  871  whose boundaries encompass a population of 100 persons or fewer
  872  per square mile;
  873         4.A hospital in a constitutional charter county with a
  874  population of over 1 million persons that has imposed a local
  875  option health service tax pursuant to law and in an area that
  876  was directly impacted by a catastrophic event on August 24,
  877  1992, for which the Governor of Florida declared a state of
  878  emergency pursuant to chapter 125, and has 120 beds or less that
  879  serves an agricultural community with an emergency room
  880  utilization of no less than 20,000 visits and a Medicaid
  881  inpatient utilization rate greater than 15 percent;
  882         4.5. A hospital with a service area that has a population
  883  of 100 persons or fewer per square mile. As used in this
  884  subparagraph, the term “service area” means the fewest number of
  885  zip codes that account for 75 percent of the hospital’s
  886  discharges for the most recent 5-year period, based on
  887  information available from the hospital inpatient discharge
  888  database in the Florida Center for Health Information and Policy
  889  Analysis at the Agency for Health Care Administration; or
  890         5.6. A hospital designated as a critical access hospital,
  891  as defined in s. 408.07(15).
  892  
  893  Population densities used in this paragraph must be based upon
  894  the most recently completed United States census. A hospital
  895  that received funds under s. 409.9116 for a quarter beginning no
  896  later than July 1, 2002, is deemed to have been and shall
  897  continue to be a rural hospital from that date through June 30,
  898  2015, if the hospital continues to have 100 or fewer licensed
  899  beds and an emergency room, or meets the criteria of
  900  subparagraph 4. An acute care hospital that has not previously
  901  been designated as a rural hospital and that meets the criteria
  902  of this paragraph shall be granted such designation upon
  903  application, including supporting documentation to the Agency
  904  for Health Care Administration.
  905         Section 23. Subsection (8) of section 400.021, Florida
  906  Statutes, is amended to read:
  907         400.021 Definitions.—When used in this part, unless the
  908  context otherwise requires, the term:
  909         (8) “Geriatric outpatient clinic” means a site for
  910  providing outpatient health care to persons 60 years of age or
  911  older, which is staffed by a registered nurse or a physician
  912  assistant, or a licensed practical nurse under the direct
  913  supervision of a registered nurse, advanced registered nurse
  914  practitioner, or physician.
  915         Section 24. Paragraph (g) of subsection (2) of section
  916  400.0239, Florida Statutes, is amended to read:
  917         400.0239 Quality of Long-Term Care Facility Improvement
  918  Trust Fund.—
  919         (2) Expenditures from the trust fund shall be allowable for
  920  direct support of the following:
  921         (g) Other initiatives authorized by the Centers for
  922  Medicare and Medicaid Services for the use of federal civil
  923  monetary penalties, including projects recommended through the
  924  Medicaid “Up-or-Out” Quality of Care Contract Management Program
  925  pursuant to s. 400.148.
  926         Section 25. Subsection (15) of section 400.0255, Florida
  927  Statutes, is amended to read
  928         400.0255 Resident transfer or discharge; requirements and
  929  procedures; hearings.—
  930         (15)(a) The department’s Office of Appeals Hearings shall
  931  conduct hearings under this section. The office shall notify the
  932  facility of a resident’s request for a hearing.
  933         (b) The department shall, by rule, establish procedures to
  934  be used for fair hearings requested by residents. These
  935  procedures shall be equivalent to the procedures used for fair
  936  hearings for other Medicaid cases appearing in s. 409.285 and
  937  applicable rules, chapter 10-2, part VI, Florida Administrative
  938  Code. The burden of proof must be clear and convincing evidence.
  939  A hearing decision must be rendered within 90 days after receipt
  940  of the request for hearing.
  941         (c) If the hearing decision is favorable to the resident
  942  who has been transferred or discharged, the resident must be
  943  readmitted to the facility’s first available bed.
  944         (d) The decision of the hearing officer shall be final. Any
  945  aggrieved party may appeal the decision to the district court of
  946  appeal in the appellate district where the facility is located.
  947  Review procedures shall be conducted in accordance with the
  948  Florida Rules of Appellate Procedure.
  949         Section 26. Subsection (2) of section 400.063, Florida
  950  Statutes, is amended to read:
  951         400.063 Resident protection.—
  952         (2) The agency is authorized to establish for each
  953  facility, subject to intervention by the agency, a separate bank
  954  account for the deposit to the credit of the agency of any
  955  moneys received from the Health Care Trust Fund or any other
  956  moneys received for the maintenance and care of residents in the
  957  facility, and the agency is authorized to disburse moneys from
  958  such account to pay obligations incurred for the purposes of
  959  this section. The agency is authorized to requisition moneys
  960  from the Health Care Trust Fund in advance of an actual need for
  961  cash on the basis of an estimate by the agency of moneys to be
  962  spent under the authority of this section. Any bank account
  963  established under this section need not be approved in advance
  964  of its creation as required by s. 17.58, but shall be secured by
  965  depository insurance equal to or greater than the balance of
  966  such account or by the pledge of collateral security in
  967  conformance with criteria established in s. 18.11. The agency
  968  shall notify the Chief Financial Officer of any such account so
  969  established and shall make a quarterly accounting to the Chief
  970  Financial Officer for all moneys deposited in such account.
  971         Section 27. Subsections (1) and (5) of section 400.071,
  972  Florida Statutes, are amended to read:
  973         400.071 Application for license.—
  974         (1) In addition to the requirements of part II of chapter
  975  408, the application for a license shall be under oath and must
  976  contain the following:
  977         (a) The location of the facility for which a license is
  978  sought and an indication, as in the original application, that
  979  such location conforms to the local zoning ordinances.
  980         (b)A signed affidavit disclosing any financial or
  981  ownership interest that a controlling interest as defined in
  982  part II of chapter 408 has held in the last 5 years in any
  983  entity licensed by this state or any other state to provide
  984  health or residential care which has closed voluntarily or
  985  involuntarily; has filed for bankruptcy; has had a receiver
  986  appointed; has had a license denied, suspended, or revoked; or
  987  has had an injunction issued against it which was initiated by a
  988  regulatory agency. The affidavit must disclose the reason any
  989  such entity was closed, whether voluntarily or involuntarily.
  990         (c)The total number of beds and the total number of
  991  Medicare and Medicaid certified beds.
  992         (b)(d) Information relating to the applicant and employees
  993  which the agency requires by rule. The applicant must
  994  demonstrate that sufficient numbers of qualified staff, by
  995  training or experience, will be employed to properly care for
  996  the type and number of residents who will reside in the
  997  facility.
  998         (c)(e) Copies of any civil verdict or judgment involving
  999  the applicant rendered within the 10 years preceding the
 1000  application, relating to medical negligence, violation of
 1001  residents’ rights, or wrongful death. As a condition of
 1002  licensure, the licensee agrees to provide to the agency copies
 1003  of any new verdict or judgment involving the applicant, relating
 1004  to such matters, within 30 days after filing with the clerk of
 1005  the court. The information required in this paragraph shall be
 1006  maintained in the facility’s licensure file and in an agency
 1007  database which is available as a public record.
 1008         (5) As a condition of licensure, each facility must
 1009  establish and submit with its application a plan for quality
 1010  assurance and for conducting risk management.
 1011         Section 28. Section 400.0712, Florida Statutes, is amended
 1012  to read:
 1013         400.0712 Application for inactive license.—
 1014         (1)As specified in this section, the agency may issue an
 1015  inactive license to a nursing home facility for all or a portion
 1016  of its beds. Any request by a licensee that a nursing home or
 1017  portion of a nursing home become inactive must be submitted to
 1018  the agency in the approved format. The facility may not initiate
 1019  any suspension of services, notify residents, or initiate
 1020  inactivity before receiving approval from the agency; and a
 1021  licensee that violates this provision may not be issued an
 1022  inactive license.
 1023         (1)(2)In addition to the powers granted under part II of
 1024  chapter 408, the agency may issue an inactive license to a
 1025  nursing home that chooses to use an unoccupied contiguous
 1026  portion of the facility for an alternative use to meet the needs
 1027  of elderly persons through the use of less restrictive, less
 1028  institutional services.
 1029         (a) An inactive license issued under this subsection may be
 1030  granted for a period not to exceed the current licensure
 1031  expiration date but may be renewed by the agency at the time of
 1032  licensure renewal.
 1033         (b) A request to extend the inactive license must be
 1034  submitted to the agency in the approved format and approved by
 1035  the agency in writing.
 1036         (c) Nursing homes that receive an inactive license to
 1037  provide alternative services shall not receive preference for
 1038  participation in the Assisted Living for the Elderly Medicaid
 1039  waiver.
 1040         (2)(3) The agency shall adopt rules pursuant to ss.
 1041  120.536(1) and 120.54 necessary to implement this section.
 1042         Section 29. Section 400.111, Florida Statutes, is amended
 1043  to read:
 1044         400.111 Disclosure of controlling interest.—In addition to
 1045  the requirements of part II of chapter 408, when requested by
 1046  the agency, the licensee shall submit a signed affidavit
 1047  disclosing any financial or ownership interest that a
 1048  controlling interest has held within the last 5 years in any
 1049  entity licensed by the state or any other state to provide
 1050  health or residential care which entity has closed voluntarily
 1051  or involuntarily; has filed for bankruptcy; has had a receiver
 1052  appointed; has had a license denied, suspended, or revoked; or
 1053  has had an injunction issued against it which was initiated by a
 1054  regulatory agency. The affidavit must disclose the reason such
 1055  entity was closed, whether voluntarily or involuntarily.
 1056         Section 30. Subsection (2) of section 400.1183, Florida
 1057  Statutes, is amended to read:
 1058         400.1183 Resident grievance procedures.—
 1059         (2) Each facility shall maintain records of all grievances
 1060  for agency inspection and shall report to the agency at the time
 1061  of relicensure the total number of grievances handled during the
 1062  prior licensure period, a categorization of the cases underlying
 1063  the grievances, and the final disposition of the grievances.
 1064         Section 31. Paragraphs (o) through (w) of subsection (1) of
 1065  section 400.141, Florida Statutes, are redesignated as
 1066  paragraphs (n) through (u), respectively, and present paragraphs
 1067  (f), (g), (j), (n), (o), and (r) of that subsection are amended,
 1068  to read:
 1069         400.141 Administration and management of nursing home
 1070  facilities.—
 1071         (1) Every licensed facility shall comply with all
 1072  applicable standards and rules of the agency and shall:
 1073         (f) Be allowed and encouraged by the agency to provide
 1074  other needed services under certain conditions. If the facility
 1075  has a standard licensure status, and has had no class I or class
 1076  II deficiencies during the past 2 years or has been awarded a
 1077  Gold Seal under the program established in s. 400.235, it may be
 1078  encouraged by the agency to provide services, including, but not
 1079  limited to, respite and adult day services, which enable
 1080  individuals to move in and out of the facility. A facility is
 1081  not subject to any additional licensure requirements for
 1082  providing these services.
 1083         1. Respite care may be offered to persons in need of short
 1084  term or temporary nursing home services. For each person
 1085  admitted under the respite care program, the facility licensee
 1086  must:
 1087         a.Have a written abbreviated plan of care that, at a
 1088  minimum, includes nutritional requirements, medication orders,
 1089  physician orders, nursing assessments, and dietary preferences.
 1090  The nursing or physician assessments may take the place of all
 1091  other assessments required for full-time residents.
 1092         b.Have a contract that, at a minimum, specifies the
 1093  services to be provided to the respite resident, including
 1094  charges for services, activities, equipment, emergency medical
 1095  services, and the administration of medications. If multiple
 1096  respite admissions for a single person are anticipated, the
 1097  original contract is valid for 1 year after the date of
 1098  execution.
 1099         c.Ensure that each resident is released to his or her
 1100  caregiver or an individual designated in writing by the
 1101  caregiver.
 1102         2.A person admitted under the respite care program is:
 1103         a.Exempt from requirements in rule related to discharge
 1104  planning.
 1105         b.Covered by the resident’s rights set forth in s.
 1106  400.022(1)(a)-(o) and (r)-(t). Funds or property of the resident
 1107  shall not be considered trust funds subject to the requirements
 1108  of s. 400.022(1)(h) until the resident has been in the facility
 1109  for more than 14 consecutive days.
 1110         c.Allowed to use his or her personal medications for the
 1111  respite stay if permitted by facility policy. The facility must
 1112  obtain a physician’s orders for the medications. The caregiver
 1113  may provide information regarding the medications as part of the
 1114  nursing assessment, which must agree with the physician’s
 1115  orders. Medications shall be released with the resident upon
 1116  discharge in accordance with current orders.
 1117         3.A person receiving respite care is entitled to a total
 1118  of 60 days in the facility within a contract year or a calendar
 1119  year if the contract is for less than 12 months. However, each
 1120  single stay may not exceed 14 days. If a stay exceeds 14
 1121  consecutive days, the facility must comply with all assessment
 1122  and care planning requirements applicable to nursing home
 1123  residents.
 1124         4.A person receiving respite care must reside in a
 1125  licensed nursing home bed.
 1126         5.A prospective respite resident must provide medical
 1127  information from a physician, a physician assistant, or a nurse
 1128  practitioner and other information from the primary caregiver as
 1129  may be required by the facility prior to or at the time of
 1130  admission to receive respite care. The medical information must
 1131  include a physician’s order for respite care and proof of a
 1132  physical examination by a licensed physician, physician
 1133  assistant, or nurse practitioner. The physician’s order and
 1134  physical examination may be used to provide intermittent respite
 1135  care for up to 12 months after the date the order is written.
 1136         6.The facility must assume the duties of the primary
 1137  caregiver. To ensure continuity of care and services, the
 1138  resident is entitled to retain his or her personal physician and
 1139  must have access to medically necessary services such as
 1140  physical therapy, occupational therapy, or speech therapy, as
 1141  needed. The facility must arrange for transportation to these
 1142  services if necessary. Respite care must be provided in
 1143  accordance with this part and rules adopted by the agency.
 1144  However, the agency shall, by rule, adopt modified requirements
 1145  for resident assessment, resident care plans, resident
 1146  contracts, physician orders, and other provisions, as
 1147  appropriate, for short-term or temporary nursing home services.
 1148         7. The agency shall allow for shared programming and staff
 1149  in a facility which meets minimum standards and offers services
 1150  pursuant to this paragraph, but, if the facility is cited for
 1151  deficiencies in patient care, may require additional staff and
 1152  programs appropriate to the needs of service recipients. A
 1153  person who receives respite care may not be counted as a
 1154  resident of the facility for purposes of the facility’s licensed
 1155  capacity unless that person receives 24-hour respite care. A
 1156  person receiving either respite care for 24 hours or longer or
 1157  adult day services must be included when calculating minimum
 1158  staffing for the facility. Any costs and revenues generated by a
 1159  nursing home facility from nonresidential programs or services
 1160  shall be excluded from the calculations of Medicaid per diems
 1161  for nursing home institutional care reimbursement.
 1162         (g) If the facility has a standard license or is a Gold
 1163  Seal facility, exceeds the minimum required hours of licensed
 1164  nursing and certified nursing assistant direct care per resident
 1165  per day, and is part of a continuing care facility licensed
 1166  under chapter 651 or a retirement community that offers other
 1167  services pursuant to part III of this chapter or part I or part
 1168  III of chapter 429 on a single campus, be allowed to share
 1169  programming and staff. At the time of inspection and in the
 1170  semiannual report required pursuant to paragraph (n) (o), a
 1171  continuing care facility or retirement community that uses this
 1172  option must demonstrate through staffing records that minimum
 1173  staffing requirements for the facility were met. Licensed nurses
 1174  and certified nursing assistants who work in the nursing home
 1175  facility may be used to provide services elsewhere on campus if
 1176  the facility exceeds the minimum number of direct care hours
 1177  required per resident per day and the total number of residents
 1178  receiving direct care services from a licensed nurse or a
 1179  certified nursing assistant does not cause the facility to
 1180  violate the staffing ratios required under s. 400.23(3)(a).
 1181  Compliance with the minimum staffing ratios shall be based on
 1182  total number of residents receiving direct care services,
 1183  regardless of where they reside on campus. If the facility
 1184  receives a conditional license, it may not share staff until the
 1185  conditional license status ends. This paragraph does not
 1186  restrict the agency’s authority under federal or state law to
 1187  require additional staff if a facility is cited for deficiencies
 1188  in care which are caused by an insufficient number of certified
 1189  nursing assistants or licensed nurses. The agency may adopt
 1190  rules for the documentation necessary to determine compliance
 1191  with this provision.
 1192         (j) Keep full records of resident admissions and
 1193  discharges; medical and general health status, including medical
 1194  records, personal and social history, and identity and address
 1195  of next of kin or other persons who may have responsibility for
 1196  the affairs of the residents; and individual resident care plans
 1197  including, but not limited to, prescribed services, service
 1198  frequency and duration, and service goals. The records shall be
 1199  open to inspection by the agency. The facility must maintain
 1200  clinical records on each resident in accordance with accepted
 1201  professional standards and practices that are complete,
 1202  accurately documented, readily accessible, and systematically
 1203  organized.
 1204         (n)Submit to the agency the information specified in s.
 1205  400.071(1)(b) for a management company within 30 days after the
 1206  effective date of the management agreement.
 1207         (n)(o)1. Submit semiannually to the agency, or more
 1208  frequently if requested by the agency, information regarding
 1209  facility staff-to-resident ratios, staff turnover, and staff
 1210  stability, including information regarding certified nursing
 1211  assistants, licensed nurses, the director of nursing, and the
 1212  facility administrator. For purposes of this reporting:
 1213         a. Staff-to-resident ratios must be reported in the
 1214  categories specified in s. 400.23(3)(a) and applicable rules.
 1215  The ratio must be reported as an average for the most recent
 1216  calendar quarter.
 1217         b. Staff turnover must be reported for the most recent 12
 1218  month period ending on the last workday of the most recent
 1219  calendar quarter prior to the date the information is submitted.
 1220  The turnover rate must be computed quarterly, with the annual
 1221  rate being the cumulative sum of the quarterly rates. The
 1222  turnover rate is the total number of terminations or separations
 1223  experienced during the quarter, excluding any employee
 1224  terminated during a probationary period of 3 months or less,
 1225  divided by the total number of staff employed at the end of the
 1226  period for which the rate is computed, and expressed as a
 1227  percentage.
 1228         c. The formula for determining staff stability is the total
 1229  number of employees that have been employed for more than 12
 1230  months, divided by the total number of employees employed at the
 1231  end of the most recent calendar quarter, and expressed as a
 1232  percentage.
 1233         d. A nursing facility that has failed to comply with state
 1234  minimum-staffing requirements for 2 consecutive days is
 1235  prohibited from accepting new admissions until the facility has
 1236  achieved the minimum-staffing requirements for a period of 6
 1237  consecutive days. For the purposes of this sub-subparagraph, any
 1238  person who was a resident of the facility and was absent from
 1239  the facility for the purpose of receiving medical care at a
 1240  separate location or was on a leave of absence is not considered
 1241  a new admission. Failure to impose such an admissions moratorium
 1242  is subject to a $1,000 fine constitutes a class II deficiency.
 1243         e. A nursing facility which does not have a conditional
 1244  license may be cited for failure to comply with the standards in
 1245  s. 400.23(3)(a)1.a. only if it has failed to meet those
 1246  standards on 2 consecutive days or if it has failed to meet at
 1247  least 97 percent of those standards on any one day.
 1248         f. A facility which has a conditional license must be in
 1249  compliance with the standards in s. 400.23(3)(a) at all times.
 1250         2. This paragraph does not limit the agency’s ability to
 1251  impose a deficiency or take other actions if a facility does not
 1252  have enough staff to meet the residents’ needs.
 1253         (r)Report to the agency any filing for bankruptcy
 1254  protection by the facility or its parent corporation,
 1255  divestiture or spin-off of its assets, or corporate
 1256  reorganization within 30 days after the completion of such
 1257  activity.
 1258         Section 32. Subsection (3) of section 400.142, Florida
 1259  Statutes, is amended to read:
 1260         400.142 Emergency medication kits; orders not to
 1261  resuscitate.—
 1262         (3) Facility staff may withhold or withdraw cardiopulmonary
 1263  resuscitation if presented with an order not to resuscitate
 1264  executed pursuant to s. 401.45. The agency shall adopt rules
 1265  providing for the implementation of such orders. Facility staff
 1266  and facilities shall not be subject to criminal prosecution or
 1267  civil liability, nor be considered to have engaged in negligent
 1268  or unprofessional conduct, for withholding or withdrawing
 1269  cardiopulmonary resuscitation pursuant to such an order and
 1270  rules adopted by the agency. The absence of an order not to
 1271  resuscitate executed pursuant to s. 401.45 does not preclude a
 1272  physician from withholding or withdrawing cardiopulmonary
 1273  resuscitation as otherwise permitted by law.
 1274         Section 33. Subsections (11) through (15) of section
 1275  400.147, Florida Statutes, are renumbered as subsections (10)
 1276  through (14), respectively, and present subsection (10) is
 1277  amended to read:
 1278         400.147 Internal risk management and quality assurance
 1279  program.—
 1280         (10)By the 10th of each month, each facility subject to
 1281  this section shall report any notice received pursuant to s.
 1282  400.0233(2) and each initial complaint that was filed with the
 1283  clerk of the court and served on the facility during the
 1284  previous month by a resident or a resident’s family member,
 1285  guardian, conservator, or personal legal representative. The
 1286  report must include the name of the resident, the resident’s
 1287  date of birth and social security number, the Medicaid
 1288  identification number for Medicaid-eligible persons, the date or
 1289  dates of the incident leading to the claim or dates of
 1290  residency, if applicable, and the type of injury or violation of
 1291  rights alleged to have occurred. Each facility shall also submit
 1292  a copy of the notices received pursuant to s. 400.0233(2) and
 1293  complaints filed with the clerk of the court. This report is
 1294  confidential as provided by law and is not discoverable or
 1295  admissible in any civil or administrative action, except in such
 1296  actions brought by the agency to enforce the provisions of this
 1297  part.
 1298         Section 34. Section 400.148, Florida Statutes, is repealed.
 1299         Section 35. Paragraph (f) of subsection (5) of section
 1300  400.162, Florida Statutes, is amended to read:
 1301         400.162 Property and personal affairs of residents.—
 1302         (5)
 1303         (f) At least every 3 months, the licensee shall furnish the
 1304  resident and the guardian, trustee, or conservator, if any, for
 1305  the resident a complete and verified statement of all funds and
 1306  other property to which this subsection applies, detailing the
 1307  amounts and items received, together with their sources and
 1308  disposition. For resident property, the licensee shall furnish
 1309  such a statement annually and within 7 calendar days after a
 1310  request for a statement. In any event, the licensee shall
 1311  furnish such statements a statement annually and upon the
 1312  discharge or transfer of a resident. Any governmental agency or
 1313  private charitable agency contributing funds or other property
 1314  on account of a resident also shall be entitled to receive such
 1315  statements statement annually and upon discharge or transfer and
 1316  such other report as it may require pursuant to law.
 1317         Section 36. Paragraphs (d) and (e) of subsection (2) of
 1318  section 400.179, Florida Statutes, are amended to read:
 1319         400.179 Liability for Medicaid underpayments and
 1320  overpayments.—
 1321         (2) Because any transfer of a nursing facility may expose
 1322  the fact that Medicaid may have underpaid or overpaid the
 1323  transferor, and because in most instances, any such underpayment
 1324  or overpayment can only be determined following a formal field
 1325  audit, the liabilities for any such underpayments or
 1326  overpayments shall be as follows:
 1327         (d) Where the transfer involves a facility that has been
 1328  leased by the transferor:
 1329         1. The transferee shall, as a condition to being issued a
 1330  license by the agency, acquire, maintain, and provide proof to
 1331  the agency of a bond with a term of 30 months, renewable
 1332  annually, in an amount not less than the total of 3 months’
 1333  Medicaid payments to the facility computed on the basis of the
 1334  preceding 12-month average Medicaid payments to the facility.
 1335         2. A leasehold licensee may meet the requirements of
 1336  subparagraph 1. by payment of a nonrefundable fee, paid at
 1337  initial licensure, paid at the time of any subsequent change of
 1338  ownership, and paid annually thereafter, in the amount of 1
 1339  percent of the total of 3 months’ Medicaid payments to the
 1340  facility computed on the basis of the preceding 12-month average
 1341  Medicaid payments to the facility. If a preceding 12-month
 1342  average is not available, projected Medicaid payments may be
 1343  used. The fee shall be deposited into the Grants and Donations
 1344  Trust Fund and shall be accounted for separately as a Medicaid
 1345  nursing home overpayment account. These fees shall be used at
 1346  the sole discretion of the agency to repay nursing home Medicaid
 1347  overpayments. Payment of this fee shall not release the licensee
 1348  from any liability for any Medicaid overpayments, nor shall
 1349  payment bar the agency from seeking to recoup overpayments from
 1350  the licensee and any other liable party. As a condition of
 1351  exercising this lease bond alternative, licensees paying this
 1352  fee must maintain an existing lease bond through the end of the
 1353  30-month term period of that bond. The agency is herein granted
 1354  specific authority to promulgate all rules pertaining to the
 1355  administration and management of this account, including
 1356  withdrawals from the account, subject to federal review and
 1357  approval. This provision shall take effect upon becoming law and
 1358  shall apply to any leasehold license application. The financial
 1359  viability of the Medicaid nursing home overpayment account shall
 1360  be determined by the agency through annual review of the account
 1361  balance and the amount of total outstanding, unpaid Medicaid
 1362  overpayments owing from leasehold licensees to the agency as
 1363  determined by final agency audits. By March 31 of each year, the
 1364  agency shall assess the cumulative fees collected under this
 1365  subparagraph, minus any amounts used to repay nursing home
 1366  Medicaid overpayments and amounts transferred to contribute to
 1367  the General Revenue Fund pursuant to s. 215.20. If the net
 1368  cumulative collections, minus amounts utilized to repay nursing
 1369  home Medicaid overpayments, exceed $25 million, the provisions
 1370  of this paragraph shall not apply for the subsequent fiscal
 1371  year.
 1372         3. The leasehold licensee may meet the bond requirement
 1373  through other arrangements acceptable to the agency. The agency
 1374  is herein granted specific authority to promulgate rules
 1375  pertaining to lease bond arrangements.
 1376         4. All existing nursing facility licensees, operating the
 1377  facility as a leasehold, shall acquire, maintain, and provide
 1378  proof to the agency of the 30-month bond required in
 1379  subparagraph 1., above, on and after July 1, 1993, for each
 1380  license renewal.
 1381         5. It shall be the responsibility of all nursing facility
 1382  operators, operating the facility as a leasehold, to renew the
 1383  30-month bond and to provide proof of such renewal to the agency
 1384  annually.
 1385         6. Any failure of the nursing facility operator to acquire,
 1386  maintain, renew annually, or provide proof to the agency shall
 1387  be grounds for the agency to deny, revoke, and suspend the
 1388  facility license to operate such facility and to take any
 1389  further action, including, but not limited to, enjoining the
 1390  facility, asserting a moratorium pursuant to part II of chapter
 1391  408, or applying for a receiver, deemed necessary to ensure
 1392  compliance with this section and to safeguard and protect the
 1393  health, safety, and welfare of the facility’s residents. A lease
 1394  agreement required as a condition of bond financing or
 1395  refinancing under s. 154.213 by a health facilities authority or
 1396  required under s. 159.30 by a county or municipality is not a
 1397  leasehold for purposes of this paragraph and is not subject to
 1398  the bond requirement of this paragraph.
 1399         (e)For the 2009-2010 fiscal year only, the provisions of
 1400  paragraph (d) shall not apply. This paragraph expires July 1,
 1401  2010.
 1402         Section 37. Subsection (3) of section 400.19, Florida
 1403  Statutes, is amended to read:
 1404         400.19 Right of entry and inspection.—
 1405         (3) The agency shall every 15 months conduct at least one
 1406  unannounced inspection to determine compliance by the licensee
 1407  with statutes, and with rules promulgated under the provisions
 1408  of those statutes, governing minimum standards of construction,
 1409  quality and adequacy of care, and rights of residents. The
 1410  survey shall be conducted every 6 months for the next 2-year
 1411  period if the facility has been cited for a class I deficiency,
 1412  has been cited for two or more class II deficiencies arising
 1413  from separate surveys or investigations within a 60-day period,
 1414  or has had three or more substantiated complaints within a 6
 1415  month period, each resulting in at least one class I or class II
 1416  deficiency. In addition to any other fees or fines in this part,
 1417  the agency shall assess a fine for each facility that is subject
 1418  to the 6-month survey cycle. The fine for the 2-year period
 1419  shall be $6,000, one-half to be paid at the completion of each
 1420  survey. The agency may adjust this fine by the change in the
 1421  Consumer Price Index, based on the 12 months immediately
 1422  preceding the increase, to cover the cost of the additional
 1423  surveys. The agency shall verify through subsequent inspection
 1424  that any deficiency identified during inspection is corrected.
 1425  However, the agency may verify the correction of a class III or
 1426  class IV deficiency unrelated to resident rights or resident
 1427  care without reinspecting the facility if adequate written
 1428  documentation has been received from the facility, which
 1429  provides assurance that the deficiency has been corrected. The
 1430  giving or causing to be given of advance notice of such
 1431  unannounced inspections by an employee of the agency to any
 1432  unauthorized person shall constitute cause for suspension of not
 1433  fewer than 5 working days according to the provisions of chapter
 1434  110.
 1435         Section 38. Section 400.195, Florida Statutes, is repealed.
 1436         Section 39. Subsection (5) of section 400.23, Florida
 1437  Statutes, is amended to read:
 1438         400.23 Rules; evaluation and deficiencies; licensure
 1439  status.—
 1440         (5)(a) The agency, in collaboration with the Division of
 1441  Children’s Medical Services Network of the Department of Health,
 1442  must, no later than December 31, 1993, adopt rules for minimum
 1443  standards of care for persons under 21 years of age who reside
 1444  in nursing home facilities. The rules must include a methodology
 1445  for reviewing a nursing home facility under ss. 408.031-408.045
 1446  which serves only persons under 21 years of age. A facility may
 1447  be exempt from these standards for specific persons between 18
 1448  and 21 years of age, if the person’s physician agrees that
 1449  minimum standards of care based on age are not necessary.
 1450         (b)The agency, in collaboration with the Division of
 1451  Children’s Medical Services Network, shall adopt rules for
 1452  minimum staffing requirements for nursing home facilities that
 1453  serve persons under 21 years of age, which shall apply in lieu
 1454  of the standards contained in subsection (3).
 1455         1.For persons under 21 years of age who require skilled
 1456  care, the requirements shall include a minimum combined average
 1457  of licensed nurses, respiratory therapists, and certified
 1458  nursing assistants of 3.9 hours of direct care per resident per
 1459  day for each nursing home facility.
 1460         2.For persons under 21 years of age who are fragile, the
 1461  requirements shall include a minimum combined average of
 1462  licensed nurses, respiratory therapists, respiratory care
 1463  practitioners, and certified nursing assistants of 5 hours of
 1464  direct care per resident per day for each nursing home facility.
 1465         Section 40. Subsection (1) of section 400.275, Florida
 1466  Statutes, is amended to read:
 1467         400.275 Agency duties.—
 1468         (1) The agency shall ensure that each newly hired nursing
 1469  home surveyor, as a part of basic training, is assigned full
 1470  time to a licensed nursing home for at least 2 days within a 7
 1471  day period to observe facility operations outside of the survey
 1472  process before the surveyor begins survey responsibilities. Such
 1473  observations may not be the sole basis of a deficiency citation
 1474  against the facility. The agency may not assign an individual to
 1475  be a member of a survey team for purposes of a survey,
 1476  evaluation, or consultation visit at a nursing home facility in
 1477  which the surveyor was an employee within the preceding 2 5
 1478  years.
 1479         Section 41. Subsection (2) of section 400.484, Florida
 1480  Statutes, is amended to read:
 1481         400.484 Right of inspection; violations deficiencies;
 1482  fines.—
 1483         (2) The agency shall impose fines for various classes of
 1484  violations deficiencies in accordance with the following
 1485  schedule:
 1486         (a) Class I violations are defined in s. 408.813. A class I
 1487  deficiency is any act, omission, or practice that results in a
 1488  patient’s death, disablement, or permanent injury, or places a
 1489  patient at imminent risk of death, disablement, or permanent
 1490  injury. Upon finding a class I violation deficiency, the agency
 1491  shall impose an administrative fine in the amount of $15,000 for
 1492  each occurrence and each day that the violation deficiency
 1493  exists.
 1494         (b) Class II violations are defined in s. 408.813. A class
 1495  II deficiency is any act, omission, or practice that has a
 1496  direct adverse effect on the health, safety, or security of a
 1497  patient. Upon finding a class II violation deficiency, the
 1498  agency shall impose an administrative fine in the amount of
 1499  $5,000 for each occurrence and each day that the violation
 1500  deficiency exists.
 1501         (c) Class III violations are defined in s. 408.813. A class
 1502  III deficiency is any act, omission, or practice that has an
 1503  indirect, adverse effect on the health, safety, or security of a
 1504  patient. Upon finding an uncorrected or repeated class III
 1505  violation deficiency, the agency shall impose an administrative
 1506  fine not to exceed $1,000 for each occurrence and each day that
 1507  the uncorrected or repeated violation deficiency exists.
 1508         (d) Class IV violations are defined in s. 408.813. A class
 1509  IV deficiency is any act, omission, or practice related to
 1510  required reports, forms, or documents which does not have the
 1511  potential of negatively affecting patients. These violations are
 1512  of a type that the agency determines do not threaten the health,
 1513  safety, or security of patients. Upon finding an uncorrected or
 1514  repeated class IV violation deficiency, the agency shall impose
 1515  an administrative fine not to exceed $500 for each occurrence
 1516  and each day that the uncorrected or repeated violation
 1517  deficiency exists.
 1518         Section 42. Paragraph (i) of subsection (1) and subsection
 1519  (4) of section 400.606, Florida Statutes, are amended to read:
 1520         400.606 License; application; renewal; conditional license
 1521  or permit; certificate of need.—
 1522         (1) In addition to the requirements of part II of chapter
 1523  408, the initial application and change of ownership application
 1524  must be accompanied by a plan for the delivery of home,
 1525  residential, and homelike inpatient hospice services to
 1526  terminally ill persons and their families. Such plan must
 1527  contain, but need not be limited to:
 1528         (i)The projected annual operating cost of the hospice.
 1529  
 1530  If the applicant is an existing licensed health care provider,
 1531  the application must be accompanied by a copy of the most recent
 1532  profit-loss statement and, if applicable, the most recent
 1533  licensure inspection report.
 1534         (4) A freestanding hospice facility that is primarily
 1535  engaged in providing inpatient and related services and that is
 1536  not otherwise licensed as a health care facility shall be
 1537  required to obtain a certificate of need. However, a
 1538  freestanding hospice facility with six or fewer beds shall not
 1539  be required to comply with institutional standards such as, but
 1540  not limited to, standards requiring sprinkler systems, emergency
 1541  electrical systems, or special lavatory devices.
 1542         Section 43. Subsection (2) of section 400.607, Florida
 1543  Statutes, is amended to read:
 1544         400.607 Denial, suspension, revocation of license;
 1545  emergency actions; imposition of administrative fine; grounds.—
 1546         (2) A violation of this part, part II of chapter 408, or
 1547  applicable rules Any of the following actions by a licensed
 1548  hospice or any of its employees shall be grounds for
 1549  administrative action by the agency against a hospice.:
 1550         (a)A violation of the provisions of this part, part II of
 1551  chapter 408, or applicable rules.
 1552         (b)An intentional or negligent act materially affecting
 1553  the health or safety of a patient.
 1554         Section 44. Section 400.915, Florida Statutes, is amended
 1555  to read:
 1556         400.915 Construction and renovation; requirements.—The
 1557  requirements for the construction or renovation of a PPEC center
 1558  shall comply with:
 1559         (1) The provisions of chapter 553, which pertain to
 1560  building construction standards, including plumbing, electrical
 1561  code, glass, manufactured buildings, accessibility for the
 1562  physically disabled;
 1563         (2) The provisions of s. 633.022 and applicable rules
 1564  pertaining to physical minimum standards for nonresidential
 1565  child care physical facilities in rule 10M-12.003, Florida
 1566  Administrative Code, Child Care Standards; and
 1567         (3) The standards or rules adopted pursuant to this part
 1568  and part II of chapter 408.
 1569         Section 45. Subsection (1) of section 400.925, Florida
 1570  Statutes, is amended to read:
 1571         400.925 Definitions.—As used in this part, the term:
 1572         (1) “Accrediting organizations” means The Joint Commission
 1573  on Accreditation of Healthcare Organizations or other national
 1574  accreditation agencies whose standards for accreditation are
 1575  comparable to those required by this part for licensure.
 1576         Section 46. Subsections (3) through (6) of section 400.931,
 1577  Florida Statutes, are renumbered as subsections (2) through (5),
 1578  respectively, and present subsection (2) of that section is
 1579  amended to read:
 1580         400.931 Application for license; fee; provisional license;
 1581  temporary permit.—
 1582         (2)As an alternative to submitting proof of financial
 1583  ability to operate as required in s. 408.810(8), the applicant
 1584  may submit a $50,000 surety bond to the agency.
 1585         Section 47. Subsection (2) of section 400.932, Florida
 1586  Statutes, is amended to read:
 1587         400.932 Administrative penalties.—
 1588         (2) A violation of this part, part II of chapter 408, or
 1589  applicable rules Any of the following actions by an employee of
 1590  a home medical equipment provider shall be are grounds for
 1591  administrative action or penalties by the agency.:
 1592         (a)Violation of this part, part II of chapter 408, or
 1593  applicable rules.
 1594         (b)An intentional, reckless, or negligent act that
 1595  materially affects the health or safety of a patient.
 1596         Section 48. Subsection (3) of section 400.967, Florida
 1597  Statutes, is amended to read:
 1598         400.967 Rules and classification of violations
 1599  deficiencies.—
 1600         (3) The agency shall adopt rules to provide that, when the
 1601  criteria established under this part and part II of chapter 408
 1602  are not met, such violations deficiencies shall be classified
 1603  according to the nature of the violation deficiency. The agency
 1604  shall indicate the classification on the face of the notice of
 1605  deficiencies as follows:
 1606         (a) Class I violations deficiencies are defined in s.
 1607  408.813 those which the agency determines present an imminent
 1608  danger to the residents or guests of the facility or a
 1609  substantial probability that death or serious physical harm
 1610  would result therefrom. The condition or practice constituting a
 1611  class I violation must be abated or eliminated immediately,
 1612  unless a fixed period of time, as determined by the agency, is
 1613  required for correction. A class I violation deficiency is
 1614  subject to a civil penalty in an amount not less than $5,000 and
 1615  not exceeding $10,000 for each violation deficiency. A fine may
 1616  be levied notwithstanding the correction of the violation
 1617  deficiency.
 1618         (b) Class II violations deficiencies are defined in s.
 1619  408.813 those which the agency determines have a direct or
 1620  immediate relationship to the health, safety, or security of the
 1621  facility residents, other than class I deficiencies. A class II
 1622  violation deficiency is subject to a civil penalty in an amount
 1623  not less than $1,000 and not exceeding $5,000 for each violation
 1624  deficiency. A citation for a class II violation deficiency shall
 1625  specify the time within which the violation deficiency must be
 1626  corrected. If a class II violation deficiency is corrected
 1627  within the time specified, no civil penalty shall be imposed,
 1628  unless it is a repeated offense.
 1629         (c) Class III violations deficiencies are defined in s.
 1630  408.813 those which the agency determines to have an indirect or
 1631  potential relationship to the health, safety, or security of the
 1632  facility residents, other than class I or class II deficiencies.
 1633  A class III violation deficiency is subject to a civil penalty
 1634  of not less than $500 and not exceeding $1,000 for each
 1635  deficiency. A citation for a class III violation deficiency
 1636  shall specify the time within which the violation deficiency
 1637  must be corrected. If a class III violation deficiency is
 1638  corrected within the time specified, no civil penalty shall be
 1639  imposed, unless it is a repeated offense.
 1640         (d)Class IV violations are defined in s. 408.813. Upon
 1641  finding an uncorrected or repeated class IV violation, the
 1642  agency shall impose an administrative fine not to exceed $500
 1643  for each occurrence and each day that the uncorrected or
 1644  repeated violation exists.
 1645         Section 49. Subsections (4) and (7) of section 400.9905,
 1646  Florida Statutes, are amended to read:
 1647         400.9905 Definitions.—
 1648         (4) “Clinic” means an entity at which health care services
 1649  are provided to individuals and which tenders charges for
 1650  reimbursement for such services, including a mobile clinic and a
 1651  portable health service or equipment provider. For purposes of
 1652  this part, the term does not include and the licensure
 1653  requirements of this part do not apply to:
 1654         (a) Entities licensed or registered by the state under
 1655  chapter 395; or entities licensed or registered by the state and
 1656  providing only health care services within the scope of services
 1657  authorized under their respective licenses granted under ss.
 1658  383.30-383.335, chapter 390, chapter 394, chapter 397, this
 1659  chapter except part X, chapter 429, chapter 463, chapter 465,
 1660  chapter 466, chapter 478, part I of chapter 483, chapter 484, or
 1661  chapter 651; end-stage renal disease providers authorized under
 1662  42 C.F.R. part 405, subpart U; or providers certified under 42
 1663  C.F.R. part 485, subpart B or subpart H; or any entity that
 1664  provides neonatal or pediatric hospital-based health care
 1665  services or other health care services by licensed practitioners
 1666  solely within a hospital licensed under chapter 395.
 1667         (b) Entities that own, directly or indirectly, entities
 1668  licensed or registered by the state pursuant to chapter 395; or
 1669  entities that own, directly or indirectly, entities licensed or
 1670  registered by the state and providing only health care services
 1671  within the scope of services authorized pursuant to their
 1672  respective licenses granted under ss. 383.30-383.335, chapter
 1673  390, chapter 394, chapter 397, this chapter except part X,
 1674  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1675  part I of chapter 483, chapter 484, chapter 651; end-stage renal
 1676  disease providers authorized under 42 C.F.R. part 405, subpart
 1677  U; or providers certified under 42 C.F.R. part 485, subpart B or
 1678  subpart H; or any entity that provides neonatal or pediatric
 1679  hospital-based health care services by licensed practitioners
 1680  solely within a hospital licensed under chapter 395.
 1681         (c) Entities that are owned, directly or indirectly, by an
 1682  entity licensed or registered by the state pursuant to chapter
 1683  395; or entities that are owned, directly or indirectly, by an
 1684  entity licensed or registered by the state and providing only
 1685  health care services within the scope of services authorized
 1686  pursuant to their respective licenses granted under ss. 383.30
 1687  383.335, chapter 390, chapter 394, chapter 397, this chapter
 1688  except part X, chapter 429, chapter 463, chapter 465, chapter
 1689  466, chapter 478, part I of chapter 483, chapter 484, or chapter
 1690  651; end-stage renal disease providers authorized under 42
 1691  C.F.R. part 405, subpart U; or providers certified under 42
 1692  C.F.R. part 485, subpart B or subpart H; or any entity that
 1693  provides neonatal or pediatric hospital-based health care
 1694  services by licensed practitioners solely within a hospital
 1695  under chapter 395.
 1696         (d) Entities that are under common ownership, directly or
 1697  indirectly, with an entity licensed or registered by the state
 1698  pursuant to chapter 395; or entities that are under common
 1699  ownership, directly or indirectly, with an entity licensed or
 1700  registered by the state and providing only health care services
 1701  within the scope of services authorized pursuant to their
 1702  respective licenses granted under ss. 383.30-383.335, chapter
 1703  390, chapter 394, chapter 397, this chapter except part X,
 1704  chapter 429, chapter 463, chapter 465, chapter 466, chapter 478,
 1705  part I of chapter 483, chapter 484, or chapter 651; end-stage
 1706  renal disease providers authorized under 42 C.F.R. part 405,
 1707  subpart U; or providers certified under 42 C.F.R. part 485,
 1708  subpart B or subpart H; or any entity that provides neonatal or
 1709  pediatric hospital-based health care services by licensed
 1710  practitioners solely within a hospital licensed under chapter
 1711  395.
 1712         (e) An entity that is exempt from federal taxation under 26
 1713  U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan
 1714  under 26 U.S.C. s. 409 that has a board of trustees not less
 1715  than two-thirds of which are Florida-licensed health care
 1716  practitioners and provides only physical therapy services under
 1717  physician orders, any community college or university clinic,
 1718  and any entity owned or operated by the federal or state
 1719  government, including agencies, subdivisions, or municipalities
 1720  thereof.
 1721         (f) A sole proprietorship, group practice, partnership, or
 1722  corporation that provides health care services by physicians
 1723  covered by s. 627.419, that is directly supervised by one or
 1724  more of such physicians, and that is wholly owned by one or more
 1725  of those physicians or by a physician and the spouse, parent,
 1726  child, or sibling of that physician.
 1727         (g) A sole proprietorship, group practice, partnership, or
 1728  corporation that provides health care services by licensed
 1729  health care practitioners under chapter 457, chapter 458,
 1730  chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
 1731  chapter 466, chapter 467, chapter 480, chapter 484, chapter 486,
 1732  chapter 490, chapter 491, or part I, part III, part X, part
 1733  XIII, or part XIV of chapter 468, or s. 464.012, which are
 1734  wholly owned by one or more licensed health care practitioners,
 1735  or the licensed health care practitioners set forth in this
 1736  paragraph and the spouse, parent, child, or sibling of a
 1737  licensed health care practitioner, so long as one of the owners
 1738  who is a licensed health care practitioner is supervising the
 1739  business activities and is legally responsible for the entity’s
 1740  compliance with all federal and state laws. However, a health
 1741  care practitioner may not supervise services beyond the scope of
 1742  the practitioner’s license, except that, for the purposes of
 1743  this part, a clinic owned by a licensee in s. 456.053(3)(b) that
 1744  provides only services authorized pursuant to s. 456.053(3)(b)
 1745  may be supervised by a licensee specified in s. 456.053(3)(b).
 1746         (h) Clinical facilities affiliated with an accredited
 1747  medical school at which training is provided for medical
 1748  students, residents, or fellows.
 1749         (i) Entities that provide only oncology or radiation
 1750  therapy services by physicians licensed under chapter 458 or
 1751  chapter 459 or entities that provide oncology or radiation
 1752  therapy services by physicians licensed under chapter 458 or
 1753  chapter 459 which are owned by a corporation whose shares are
 1754  publicly traded on a recognized stock exchange.
 1755         (j) Clinical facilities affiliated with a college of
 1756  chiropractic accredited by the Council on Chiropractic Education
 1757  at which training is provided for chiropractic students.
 1758         (k) Entities that provide licensed practitioners to staff
 1759  emergency departments or to deliver anesthesia services in
 1760  facilities licensed under chapter 395 and that derive at least
 1761  90 percent of their gross annual revenues from the provision of
 1762  such services. Entities claiming an exemption from licensure
 1763  under this paragraph must provide documentation demonstrating
 1764  compliance.
 1765         (l) Orthotic, or prosthetic, pediatric cardiology, or
 1766  perinatology clinical facilities that are a publicly traded
 1767  corporation or that are wholly owned, directly or indirectly, by
 1768  a publicly traded corporation. As used in this paragraph, a
 1769  publicly traded corporation is a corporation that issues
 1770  securities traded on an exchange registered with the United
 1771  States Securities and Exchange Commission as a national
 1772  securities exchange.
 1773         (m)Entities that are owned by a corporation that has $250
 1774  million or more in total annual sales of health care services
 1775  provided by licensed health care practitioners if one or more of
 1776  the owners of the entity is a health care practitioner who is
 1777  licensed in this state, is responsible for supervising the
 1778  business activities of the entity, and is legally responsible
 1779  for the entity’s compliance with state law for purposes of this
 1780  section.
 1781         (n)Entities that are owned or controlled, directly or
 1782  indirectly, by a publicly traded entity with $100 million or
 1783  more, in the aggregate, in total annual revenues derived from
 1784  providing health care services by licensed health care
 1785  practitioners that are employed or contracted by an entity
 1786  described in this paragraph.
 1787         (7) “Portable health service or equipment provider” means
 1788  an entity that contracts with or employs persons to provide
 1789  portable health care services or equipment to multiple locations
 1790  performing treatment or diagnostic testing of individuals, that
 1791  bills third-party payors for those services, and that otherwise
 1792  meets the definition of a clinic in subsection (4).
 1793         Section 50. Paragraph (b) of subsection (1) and paragraph
 1794  (c) of subsection (4) of section 400.991, Florida Statutes, are
 1795  amended to read:
 1796         400.991 License requirements; background screenings;
 1797  prohibitions.—
 1798         (1)
 1799         (b) Each mobile clinic must obtain a separate health care
 1800  clinic license and must provide to the agency, at least
 1801  quarterly, its projected street location to enable the agency to
 1802  locate and inspect such clinic. A portable health service or
 1803  equipment provider must obtain a health care clinic license for
 1804  a single administrative office and is not required to submit
 1805  quarterly projected street locations.
 1806         (4) In addition to the requirements of part II of chapter
 1807  408, the applicant must file with the application satisfactory
 1808  proof that the clinic is in compliance with this part and
 1809  applicable rules, including:
 1810         (c) Proof of financial ability to operate as required under
 1811  ss. s. 408.810(8) and 408.8065. As an alternative to submitting
 1812  proof of financial ability to operate as required under s.
 1813  408.810(8), the applicant may file a surety bond of at least
 1814  $500,000 which guarantees that the clinic will act in full
 1815  conformity with all legal requirements for operating a clinic,
 1816  payable to the agency. The agency may adopt rules to specify
 1817  related requirements for such surety bond.
 1818         Section 51. Paragraph (g) of subsection (1) and paragraph
 1819  (a) of subsection (7) of section 400.9935, Florida Statutes, are
 1820  amended to read:
 1821         400.9935 Clinic responsibilities.—
 1822         (1) Each clinic shall appoint a medical director or clinic
 1823  director who shall agree in writing to accept legal
 1824  responsibility for the following activities on behalf of the
 1825  clinic. The medical director or the clinic director shall:
 1826         (g) Conduct systematic reviews of clinic billings to ensure
 1827  that the billings are not fraudulent or unlawful. Upon discovery
 1828  of an unlawful charge, the medical director or clinic director
 1829  shall take immediate corrective action. If the clinic performs
 1830  only the technical component of magnetic resonance imaging,
 1831  static radiographs, computed tomography, or positron emission
 1832  tomography, and provides the professional interpretation of such
 1833  services, in a fixed facility that is accredited by The Joint
 1834  Commission on Accreditation of Healthcare Organizations or the
 1835  Accreditation Association for Ambulatory Health Care, and the
 1836  American College of Radiology; and if, in the preceding quarter,
 1837  the percentage of scans performed by that clinic which was
 1838  billed to all personal injury protection insurance carriers was
 1839  less than 15 percent, the chief financial officer of the clinic
 1840  may, in a written acknowledgment provided to the agency, assume
 1841  the responsibility for the conduct of the systematic reviews of
 1842  clinic billings to ensure that the billings are not fraudulent
 1843  or unlawful.
 1844         (7)(a) Each clinic engaged in magnetic resonance imaging
 1845  services must be accredited by The Joint Commission on
 1846  Accreditation of Healthcare Organizations, the American College
 1847  of Radiology, or the Accreditation Association for Ambulatory
 1848  Health Care, within 1 year after licensure. A clinic that is
 1849  accredited by the American College of Radiology or is within the
 1850  original 1-year period after licensure and replaces its core
 1851  magnetic resonance imaging equipment shall be given 1 year after
 1852  the date on which the equipment is replaced to attain
 1853  accreditation. However, a clinic may request a single, 6-month
 1854  extension if it provides evidence to the agency establishing
 1855  that, for good cause shown, such clinic cannot be accredited
 1856  within 1 year after licensure, and that such accreditation will
 1857  be completed within the 6-month extension. After obtaining
 1858  accreditation as required by this subsection, each such clinic
 1859  must maintain accreditation as a condition of renewal of its
 1860  license. A clinic that files a change of ownership application
 1861  must comply with the original accreditation timeframe
 1862  requirements of the transferor. The agency shall deny a change
 1863  of ownership application if the clinic is not in compliance with
 1864  the accreditation requirements. When a clinic adds, replaces, or
 1865  modifies magnetic resonance imaging equipment and the
 1866  accreditation agency requires new accreditation, the clinic must
 1867  be accredited within 1 year after the date of the addition,
 1868  replacement, or modification but may request a single, 6-month
 1869  extension if the clinic provides evidence of good cause to the
 1870  agency.
 1871         Section 52. Subsection (2) of section 408.034, Florida
 1872  Statutes, is amended to read:
 1873         408.034 Duties and responsibilities of agency; rules.—
 1874         (2) In the exercise of its authority to issue licenses to
 1875  health care facilities and health service providers, as provided
 1876  under chapters 393 and 395 and parts II, and IV, and VIII of
 1877  chapter 400, the agency may not issue a license to any health
 1878  care facility or health service provider that fails to receive a
 1879  certificate of need or an exemption for the licensed facility or
 1880  service.
 1881         Section 53. Paragraph (d) of subsection (1) of section
 1882  408.036, Florida Statutes, is amended to read:
 1883         408.036 Projects subject to review; exemptions.—
 1884         (1) APPLICABILITY.—Unless exempt under subsection (3), all
 1885  health-care-related projects, as described in paragraphs (a)
 1886  (g), are subject to review and must file an application for a
 1887  certificate of need with the agency. The agency is exclusively
 1888  responsible for determining whether a health-care-related
 1889  project is subject to review under ss. 408.031-408.045.
 1890         (d) The establishment of a hospice or hospice inpatient
 1891  facility, except as provided in s. 408.043.
 1892         Section 54. Subsection (2) of section 408.043, Florida
 1893  Statutes, is amended to read:
 1894         408.043 Special provisions.—
 1895         (2) HOSPICES.—When an application is made for a certificate
 1896  of need to establish or to expand a hospice, the need for such
 1897  hospice shall be determined on the basis of the need for and
 1898  availability of hospice services in the community. The formula
 1899  on which the certificate of need is based shall discourage
 1900  regional monopolies and promote competition. The inpatient
 1901  hospice care component of a hospice which is a freestanding
 1902  facility, or a part of a facility, which is primarily engaged in
 1903  providing inpatient care and related services and is not
 1904  licensed as a health care facility shall also be required to
 1905  obtain a certificate of need. Provision of hospice care by any
 1906  current provider of health care is a significant change in
 1907  service and therefore requires a certificate of need for such
 1908  services.
 1909         Section 55. Paragraph (k) of subsection (3) of section
 1910  408.05, Florida Statutes, is amended to read:
 1911         408.05 Florida Center for Health Information and Policy
 1912  Analysis.—
 1913         (3) COMPREHENSIVE HEALTH INFORMATION SYSTEM.—In order to
 1914  produce comparable and uniform health information and statistics
 1915  for the development of policy recommendations, the agency shall
 1916  perform the following functions:
 1917         (k) Develop, in conjunction with the State Consumer Health
 1918  Information and Policy Advisory Council, and implement a long
 1919  range plan for making available health care quality measures and
 1920  financial data that will allow consumers to compare health care
 1921  services. The health care quality measures and financial data
 1922  the agency must make available shall include, but is not limited
 1923  to, pharmaceuticals, physicians, health care facilities, and
 1924  health plans and managed care entities. The agency shall submit
 1925  the initial plan to the Governor, the President of the Senate,
 1926  and the Speaker of the House of Representatives by January 1,
 1927  2006, and shall update the plan and report on the status of its
 1928  implementation annually thereafter. The agency shall also make
 1929  the plan and status report available to the public on its
 1930  Internet website. As part of the plan, the agency shall identify
 1931  the process and timeframes for implementation, any barriers to
 1932  implementation, and recommendations of changes in the law that
 1933  may be enacted by the Legislature to eliminate the barriers. As
 1934  preliminary elements of the plan, the agency shall:
 1935         1. Make available patient-safety indicators, inpatient
 1936  quality indicators, and performance outcome and patient charge
 1937  data collected from health care facilities pursuant to s.
 1938  408.061(1)(a) and (2). The terms “patient-safety indicators” and
 1939  “inpatient quality indicators” shall be as defined by the
 1940  Centers for Medicare and Medicaid Services, the National Quality
 1941  Forum, The Joint Commission on Accreditation of Healthcare
 1942  Organizations, the Agency for Healthcare Research and Quality,
 1943  the Centers for Disease Control and Prevention, or a similar
 1944  national entity that establishes standards to measure the
 1945  performance of health care providers, or by other states. The
 1946  agency shall determine which conditions, procedures, health care
 1947  quality measures, and patient charge data to disclose based upon
 1948  input from the council. When determining which conditions and
 1949  procedures are to be disclosed, the council and the agency shall
 1950  consider variation in costs, variation in outcomes, and
 1951  magnitude of variations and other relevant information. When
 1952  determining which health care quality measures to disclose, the
 1953  agency:
 1954         a. Shall consider such factors as volume of cases; average
 1955  patient charges; average length of stay; complication rates;
 1956  mortality rates; and infection rates, among others, which shall
 1957  be adjusted for case mix and severity, if applicable.
 1958         b. May consider such additional measures that are adopted
 1959  by the Centers for Medicare and Medicaid Studies, National
 1960  Quality Forum, The Joint Commission on Accreditation of
 1961  Healthcare Organizations, the Agency for Healthcare Research and
 1962  Quality, Centers for Disease Control and Prevention, or a
 1963  similar national entity that establishes standards to measure
 1964  the performance of health care providers, or by other states.
 1965  
 1966  When determining which patient charge data to disclose, the
 1967  agency shall include such measures as the average of
 1968  undiscounted charges on frequently performed procedures and
 1969  preventive diagnostic procedures, the range of procedure charges
 1970  from highest to lowest, average net revenue per adjusted patient
 1971  day, average cost per adjusted patient day, and average cost per
 1972  admission, among others.
 1973         2. Make available performance measures, benefit design, and
 1974  premium cost data from health plans licensed pursuant to chapter
 1975  627 or chapter 641. The agency shall determine which health care
 1976  quality measures and member and subscriber cost data to
 1977  disclose, based upon input from the council. When determining
 1978  which data to disclose, the agency shall consider information
 1979  that may be required by either individual or group purchasers to
 1980  assess the value of the product, which may include membership
 1981  satisfaction, quality of care, current enrollment or membership,
 1982  coverage areas, accreditation status, premium costs, plan costs,
 1983  premium increases, range of benefits, copayments and
 1984  deductibles, accuracy and speed of claims payment, credentials
 1985  of physicians, number of providers, names of network providers,
 1986  and hospitals in the network. Health plans shall make available
 1987  to the agency any such data or information that is not currently
 1988  reported to the agency or the office.
 1989         3. Determine the method and format for public disclosure of
 1990  data reported pursuant to this paragraph. The agency shall make
 1991  its determination based upon input from the State Consumer
 1992  Health Information and Policy Advisory Council. At a minimum,
 1993  the data shall be made available on the agency’s Internet
 1994  website in a manner that allows consumers to conduct an
 1995  interactive search that allows them to view and compare the
 1996  information for specific providers. The website must include
 1997  such additional information as is determined necessary to ensure
 1998  that the website enhances informed decisionmaking among
 1999  consumers and health care purchasers, which shall include, at a
 2000  minimum, appropriate guidance on how to use the data and an
 2001  explanation of why the data may vary from provider to provider.
 2002  The data specified in subparagraph 1. shall be released no later
 2003  than January 1, 2006, for the reporting of infection rates, and
 2004  no later than October 1, 2005, for mortality rates and
 2005  complication rates. The data specified in subparagraph 2. shall
 2006  be released no later than October 1, 2006.
 2007         4. Publish on its website undiscounted charges for no fewer
 2008  than 150 of the most commonly performed adult and pediatric
 2009  procedures, including outpatient, inpatient, diagnostic, and
 2010  preventative procedures.
 2011         Section 56. Paragraph (a) of subsection (1) of section
 2012  408.061, Florida Statutes, is amended to read:
 2013         408.061 Data collection; uniform systems of financial
 2014  reporting; information relating to physician charges;
 2015  confidential information; immunity.—
 2016         (1) The agency shall require the submission by health care
 2017  facilities, health care providers, and health insurers of data
 2018  necessary to carry out the agency’s duties. Specifications for
 2019  data to be collected under this section shall be developed by
 2020  the agency with the assistance of technical advisory panels
 2021  including representatives of affected entities, consumers,
 2022  purchasers, and such other interested parties as may be
 2023  determined by the agency.
 2024         (a) Data submitted by health care facilities, including the
 2025  facilities as defined in chapter 395, shall include, but are not
 2026  limited to: case-mix data, patient admission and discharge data,
 2027  hospital emergency department data which shall include the
 2028  number of patients treated in the emergency department of a
 2029  licensed hospital reported by patient acuity level, data on
 2030  hospital-acquired infections as specified by rule, data on
 2031  complications as specified by rule, data on readmissions as
 2032  specified by rule, with patient and provider-specific
 2033  identifiers included, actual charge data by diagnostic groups,
 2034  financial data, accounting data, operating expenses, expenses
 2035  incurred for rendering services to patients who cannot or do not
 2036  pay, interest charges, depreciation expenses based on the
 2037  expected useful life of the property and equipment involved, and
 2038  demographic data. The agency shall adopt nationally recognized
 2039  risk adjustment methodologies or software consistent with the
 2040  standards of the Agency for Healthcare Research and Quality and
 2041  as selected by the agency for all data submitted as required by
 2042  this section. Data may be obtained from documents such as, but
 2043  not limited to: leases, contracts, debt instruments, itemized
 2044  patient bills, medical record abstracts, and related diagnostic
 2045  information. Reported data elements shall be reported
 2046  electronically and in accordance with rule 59E-7.012, Florida
 2047  Administrative Code. Data submitted shall be certified by the
 2048  chief executive officer or an appropriate and duly authorized
 2049  representative or employee of the licensed facility that the
 2050  information submitted is true and accurate.
 2051         Section 57. Subsection (43) of section 408.07, Florida
 2052  Statutes, is amended to read:
 2053         408.07 Definitions.—As used in this chapter, with the
 2054  exception of ss. 408.031-408.045, the term:
 2055         (43) “Rural hospital” means an acute care hospital licensed
 2056  under chapter 395, having 100 or fewer licensed beds and an
 2057  emergency room, and which is:
 2058         (a) The sole provider within a county with a population
 2059  density of no greater than 100 persons per square mile;
 2060         (b) An acute care hospital, in a county with a population
 2061  density of no greater than 100 persons per square mile, which is
 2062  at least 30 minutes of travel time, on normally traveled roads
 2063  under normal traffic conditions, from another acute care
 2064  hospital within the same county;
 2065         (c) A hospital supported by a tax district or subdistrict
 2066  whose boundaries encompass a population of 100 persons or fewer
 2067  per square mile;
 2068         (d) A hospital with a service area that has a population of
 2069  100 persons or fewer per square mile. As used in this paragraph,
 2070  the term “service area” means the fewest number of zip codes
 2071  that account for 75 percent of the hospital’s discharges for the
 2072  most recent 5-year period, based on information available from
 2073  the hospital inpatient discharge database in the Florida Center
 2074  for Health Information and Policy Analysis at the Agency for
 2075  Health Care Administration; or
 2076         (e) A critical access hospital.
 2077  
 2078  Population densities used in this subsection must be based upon
 2079  the most recently completed United States census. A hospital
 2080  that received funds under s. 409.9116 for a quarter beginning no
 2081  later than July 1, 2002, is deemed to have been and shall
 2082  continue to be a rural hospital from that date through June 30,
 2083  2015, if the hospital continues to have 100 or fewer licensed
 2084  beds and an emergency room, or meets the criteria of s.
 2085  395.602(2)(e)4. An acute care hospital that has not previously
 2086  been designated as a rural hospital and that meets the criteria
 2087  of this subsection shall be granted such designation upon
 2088  application, including supporting documentation, to the Agency
 2089  for Health Care Administration.
 2090         Section 58. Section 408.10, Florida Statutes, is amended to
 2091  read:
 2092         408.10 Consumer complaints.—The agency shall:
 2093         (1) publish and make available to the public a toll-free
 2094  telephone number for the purpose of handling consumer complaints
 2095  and shall serve as a liaison between consumer entities and other
 2096  private entities and governmental entities for the disposition
 2097  of problems identified by consumers of health care.
 2098         (2)Be empowered to investigate consumer complaints
 2099  relating to problems with health care facilities’ billing
 2100  practices and issue reports to be made public in any cases where
 2101  the agency determines the health care facility has engaged in
 2102  billing practices which are unreasonable and unfair to the
 2103  consumer.
 2104         Section 59. Subsections (12) through (30) of section
 2105  408.802, Florida Statutes, are renumbered as subsections (11)
 2106  through (29), respectively, and present subsection (11) of that
 2107  section is amended to read:
 2108         408.802 Applicability.—The provisions of this part apply to
 2109  the provision of services that require licensure as defined in
 2110  this part and to the following entities licensed, registered, or
 2111  certified by the agency, as described in chapters 112, 383, 390,
 2112  394, 395, 400, 429, 440, 483, and 765:
 2113         (11)Private review agents, as provided under part I of
 2114  chapter 395.
 2115         Section 60. Subsection (3) is added to section 408.804,
 2116  Florida Statutes, to read:
 2117         408.804 License required; display.—
 2118         (3)Any person who knowingly alters, defaces, or falsifies
 2119  a license certificate issued by the agency, or causes or
 2120  procures any person to commit such an offense, commits a
 2121  misdemeanor of the second degree, punishable as provided in s.
 2122  775.082 or s 775.083. Any licensee or provider who displays an
 2123  altered, defaced, or falsified license certificate is subject to
 2124  the penalties set forth in s. 408.815 and an administrative fine
 2125  of $1,000 for each day of illegal display.
 2126         Section 61. Paragraph (d) of subsection (2) of section
 2127  408.806, Florida Statutes, is amended, present subsections (3)
 2128  through (8) are renumbered as subsections (4) through (9),
 2129  respectively, and a new subsection (3) is added to that section,
 2130  to read:
 2131         408.806 License application process.—
 2132         (2)
 2133         (d) The agency shall notify the licensee by mail or
 2134  electronically at least 90 days before the expiration of a
 2135  license that a renewal license is necessary to continue
 2136  operation. The licensee’s failure to timely file submit a
 2137  renewal application and license application fee with the agency
 2138  shall result in a $50 per day late fee charged to the licensee
 2139  by the agency; however, the aggregate amount of the late fee may
 2140  not exceed 50 percent of the licensure fee or $500, whichever is
 2141  less. The agency shall provide a courtesy notice to the licensee
 2142  by United States mail, electronically, or by any other manner at
 2143  its address of record or mailing address, if provided, at least
 2144  90 days prior to the expiration of a license informing the
 2145  licensee of the expiration of the license. If the agency does
 2146  not provide the courtesy notice or the licensee does not receive
 2147  the courtesy notice, the licensee continues to be legally
 2148  obligated to timely file the renewal application and license
 2149  application fee with the agency and is not excused from the
 2150  payment of a late fee. If an application is received after the
 2151  required filing date and exhibits a hand-canceled postmark
 2152  obtained from a United States post office dated on or before the
 2153  required filing date, no fine will be levied.
 2154         (3)Payment of the late fee is required to consider any
 2155  late application complete, and failure to pay the late fee is
 2156  considered an omission from the application.
 2157         Section 62. Subsections (6) and (9) of section 408.810,
 2158  Florida Statutes, are amended to read:
 2159         408.810 Minimum licensure requirements.—In addition to the
 2160  licensure requirements specified in this part, authorizing
 2161  statutes, and applicable rules, each applicant and licensee must
 2162  comply with the requirements of this section in order to obtain
 2163  and maintain a license.
 2164         (6)(a) An applicant must provide the agency with proof of
 2165  the applicant’s legal right to occupy the property before a
 2166  license may be issued. Proof may include, but need not be
 2167  limited to, copies of warranty deeds, lease or rental
 2168  agreements, contracts for deeds, quitclaim deeds, or other such
 2169  documentation.
 2170         (b)In the event the property is encumbered by a mortgage
 2171  or is leased, an applicant must provide the agency with proof
 2172  that the mortgagor or landlord has been provided written notice
 2173  of the applicant’s intent as mortgagee or tenant to provide
 2174  services that require licensure and instruct the mortgagor or
 2175  landlord to serve the agency by certified mail with copies of
 2176  any foreclosure or eviction actions initiated by the mortgagor
 2177  or landlord against the applicant.
 2178         (9) A controlling interest may not withhold from the agency
 2179  any evidence of financial instability, including, but not
 2180  limited to, checks returned due to insufficient funds,
 2181  delinquent accounts, nonpayment of withholding taxes, unpaid
 2182  utility expenses, nonpayment for essential services, or adverse
 2183  court action concerning the financial viability of the provider
 2184  or any other provider licensed under this part that is under the
 2185  control of the controlling interest. A controlling interest
 2186  shall notify the agency within 10 days after a court action to
 2187  initiate bankruptcy, foreclosure, or eviction proceedings
 2188  concerning the provider, in which the controlling interest is a
 2189  petitioner or defendant. Any person who violates this subsection
 2190  commits a misdemeanor of the second degree, punishable as
 2191  provided in s. 775.082 or s. 775.083. Each day of continuing
 2192  violation is a separate offense.
 2193         Section 63. Subsection (3) is added to section 408.813,
 2194  Florida Statutes, to read:
 2195         408.813 Administrative fines; violations.—As a penalty for
 2196  any violation of this part, authorizing statutes, or applicable
 2197  rules, the agency may impose an administrative fine.
 2198         (3)The agency may impose an administrative fine for a
 2199  violation that does not qualify as a class I, class II, class
 2200  III, or class IV violation. Unless otherwise specified by law,
 2201  the amount of the fine shall not exceed $500 for each violation.
 2202  Unclassified violations may include:
 2203         (a)Violating any term or condition of a license.
 2204         (b)Violating any provision of this part, authorizing
 2205  statutes, or applicable rules.
 2206         (c)Exceeding licensed capacity.
 2207         (d)Providing services beyond the scope of the license.
 2208         (e)Violating a moratorium imposed pursuant to s. 408.814.
 2209         Section 64. Subsection (5) is added to section 408.815,
 2210  Florida Statutes, to read:
 2211         408.815 License or application denial; revocation.—
 2212         (5)In order to ensure the health, safety, and welfare of
 2213  clients when a license has been denied, revoked, or is set to
 2214  terminate, the agency may extend the license expiration date for
 2215  a period of up to 30 days for the sole purpose of allowing the
 2216  safe and orderly discharge of clients. The agency may impose
 2217  conditions on the extension, including, but not limited to,
 2218  prohibiting or limiting admissions, expedited discharge
 2219  planning, required status reports, and mandatory monitoring by
 2220  the agency or third parties. In imposing these conditions, the
 2221  agency shall take into consideration the nature and number of
 2222  clients, the availability and location of acceptable alternative
 2223  placements, and the ability of the licensee to continue
 2224  providing care to the clients. The agency may terminate the
 2225  extension or modify the conditions at any time. This authority
 2226  is in addition to any other authority granted to the agency
 2227  under chapter 120, this part, and authorizing statutes but
 2228  creates no right or entitlement to an extension of a license
 2229  expiration date.
 2230         Section 65. Paragraph (k) of subsection (4) of section
 2231  409.221, Florida Statutes, is amended to read:
 2232         409.221 Consumer-directed care program.—
 2233         (4) CONSUMER-DIRECTED CARE.—
 2234         (k)Reviews and reports.The agency and the Departments of
 2235  Elderly Affairs, Health, and Children and Family Services and
 2236  the Agency for Persons with Disabilities shall each, on an
 2237  ongoing basis, review and assess the implementation of the
 2238  consumer-directed care program. By January 15 of each year, the
 2239  agency shall submit a written report to the Legislature that
 2240  includes each department’s review of the program and contains
 2241  recommendations for improvements to the program.
 2242         Section 66. Subsection (1) of section 409.91196, Florida
 2243  Statutes, is amended to read:
 2244         409.91196 Supplemental rebate agreements; public records
 2245  and public meetings exemption.—
 2246         (1) The rebate amount, percent of rebate, manufacturer’s
 2247  pricing, and supplemental rebate, and other trade secrets as
 2248  defined in s. 688.002 that the agency has identified for use in
 2249  negotiations, held by the Agency for Health Care Administration
 2250  under s. 409.912(39)(a)8.7. are confidential and exempt from s.
 2251  119.07(1) and s. 24(a), Art. I of the State Constitution.
 2252         Section 67. Paragraph (a) of subsection (39) of section
 2253  409.912, Florida Statutes, is amended to read:
 2254         409.912 Cost-effective purchasing of health care.—The
 2255  agency shall purchase goods and services for Medicaid recipients
 2256  in the most cost-effective manner consistent with the delivery
 2257  of quality medical care. To ensure that medical services are
 2258  effectively utilized, the agency may, in any case, require a
 2259  confirmation or second physician’s opinion of the correct
 2260  diagnosis for purposes of authorizing future services under the
 2261  Medicaid program. This section does not restrict access to
 2262  emergency services or poststabilization care services as defined
 2263  in 42 C.F.R. part 438.114. Such confirmation or second opinion
 2264  shall be rendered in a manner approved by the agency. The agency
 2265  shall maximize the use of prepaid per capita and prepaid
 2266  aggregate fixed-sum basis services when appropriate and other
 2267  alternative service delivery and reimbursement methodologies,
 2268  including competitive bidding pursuant to s. 287.057, designed
 2269  to facilitate the cost-effective purchase of a case-managed
 2270  continuum of care. The agency shall also require providers to
 2271  minimize the exposure of recipients to the need for acute
 2272  inpatient, custodial, and other institutional care and the
 2273  inappropriate or unnecessary use of high-cost services. The
 2274  agency shall contract with a vendor to monitor and evaluate the
 2275  clinical practice patterns of providers in order to identify
 2276  trends that are outside the normal practice patterns of a
 2277  provider’s professional peers or the national guidelines of a
 2278  provider’s professional association. The vendor must be able to
 2279  provide information and counseling to a provider whose practice
 2280  patterns are outside the norms, in consultation with the agency,
 2281  to improve patient care and reduce inappropriate utilization.
 2282  The agency may mandate prior authorization, drug therapy
 2283  management, or disease management participation for certain
 2284  populations of Medicaid beneficiaries, certain drug classes, or
 2285  particular drugs to prevent fraud, abuse, overuse, and possible
 2286  dangerous drug interactions. The Pharmaceutical and Therapeutics
 2287  Committee shall make recommendations to the agency on drugs for
 2288  which prior authorization is required. The agency shall inform
 2289  the Pharmaceutical and Therapeutics Committee of its decisions
 2290  regarding drugs subject to prior authorization. The agency is
 2291  authorized to limit the entities it contracts with or enrolls as
 2292  Medicaid providers by developing a provider network through
 2293  provider credentialing. The agency may competitively bid single
 2294  source-provider contracts if procurement of goods or services
 2295  results in demonstrated cost savings to the state without
 2296  limiting access to care. The agency may limit its network based
 2297  on the assessment of beneficiary access to care, provider
 2298  availability, provider quality standards, time and distance
 2299  standards for access to care, the cultural competence of the
 2300  provider network, demographic characteristics of Medicaid
 2301  beneficiaries, practice and provider-to-beneficiary standards,
 2302  appointment wait times, beneficiary use of services, provider
 2303  turnover, provider profiling, provider licensure history,
 2304  previous program integrity investigations and findings, peer
 2305  review, provider Medicaid policy and billing compliance records,
 2306  clinical and medical record audits, and other factors. Providers
 2307  shall not be entitled to enrollment in the Medicaid provider
 2308  network. The agency shall determine instances in which allowing
 2309  Medicaid beneficiaries to purchase durable medical equipment and
 2310  other goods is less expensive to the Medicaid program than long
 2311  term rental of the equipment or goods. The agency may establish
 2312  rules to facilitate purchases in lieu of long-term rentals in
 2313  order to protect against fraud and abuse in the Medicaid program
 2314  as defined in s. 409.913. The agency may seek federal waivers
 2315  necessary to administer these policies.
 2316         (39)(a) The agency shall implement a Medicaid prescribed
 2317  drug spending-control program that includes the following
 2318  components:
 2319         1. A Medicaid preferred drug list, which shall be a listing
 2320  of cost-effective therapeutic options recommended by the
 2321  Medicaid Pharmacy and Therapeutics Committee established
 2322  pursuant to s. 409.91195 and adopted by the agency for each
 2323  therapeutic class on the preferred drug list. At the discretion
 2324  of the committee, and when feasible, the preferred drug list
 2325  should include at least two products in a therapeutic class. The
 2326  agency may post the preferred drug list and updates to the
 2327  preferred drug list on an Internet website without following the
 2328  rulemaking procedures of chapter 120. Antiretroviral agents are
 2329  excluded from the preferred drug list. The agency shall also
 2330  limit the amount of a prescribed drug dispensed to no more than
 2331  a 34-day supply unless the drug products’ smallest marketed
 2332  package is greater than a 34-day supply, or the drug is
 2333  determined by the agency to be a maintenance drug in which case
 2334  a 100-day maximum supply may be authorized. The agency is
 2335  authorized to seek any federal waivers necessary to implement
 2336  these cost-control programs and to continue participation in the
 2337  federal Medicaid rebate program, or alternatively to negotiate
 2338  state-only manufacturer rebates. The agency may adopt rules to
 2339  implement this subparagraph. The agency shall continue to
 2340  provide unlimited contraceptive drugs and items. The agency must
 2341  establish procedures to ensure that:
 2342         a. There is a response to a request for prior consultation
 2343  by telephone or other telecommunication device within 24 hours
 2344  after receipt of a request for prior consultation; and
 2345         b. A 72-hour supply of the drug prescribed is provided in
 2346  an emergency or when the agency does not provide a response
 2347  within 24 hours as required by sub-subparagraph a.
 2348         2. Reimbursement to pharmacies for Medicaid prescribed
 2349  drugs shall be set at the lesser of: the average wholesale price
 2350  (AWP) minus 16.4 percent, the wholesaler acquisition cost (WAC)
 2351  plus 4.75 percent, the federal upper limit (FUL), the state
 2352  maximum allowable cost (SMAC), or the usual and customary (UAC)
 2353  charge billed by the provider.
 2354         3.For a prescribed drug billed as a 340B prescribed
 2355  medication, the claim must meet the requirements of the Deficit
 2356  Reduction Act of 2005 and the federal 340B program, contain a
 2357  national drug code, and be billed at the actual acquisition cost
 2358  or payment shall be denied.
 2359         4.3. The agency shall develop and implement a process for
 2360  managing the drug therapies of Medicaid recipients who are using
 2361  significant numbers of prescribed drugs each month. The
 2362  management process may include, but is not limited to,
 2363  comprehensive, physician-directed medical-record reviews, claims
 2364  analyses, and case evaluations to determine the medical
 2365  necessity and appropriateness of a patient’s treatment plan and
 2366  drug therapies. The agency may contract with a private
 2367  organization to provide drug-program-management services. The
 2368  Medicaid drug benefit management program shall include
 2369  initiatives to manage drug therapies for HIV/AIDS patients,
 2370  patients using 20 or more unique prescriptions in a 180-day
 2371  period, and the top 1,000 patients in annual spending. The
 2372  agency shall enroll any Medicaid recipient in the drug benefit
 2373  management program if he or she meets the specifications of this
 2374  provision and is not enrolled in a Medicaid health maintenance
 2375  organization.
 2376         5.4. The agency may limit the size of its pharmacy network
 2377  based on need, competitive bidding, price negotiations,
 2378  credentialing, or similar criteria. The agency shall give
 2379  special consideration to rural areas in determining the size and
 2380  location of pharmacies included in the Medicaid pharmacy
 2381  network. A pharmacy credentialing process may include criteria
 2382  such as a pharmacy’s full-service status, location, size,
 2383  patient educational programs, patient consultation, disease
 2384  management services, and other characteristics. The agency may
 2385  impose a moratorium on Medicaid pharmacy enrollment when it is
 2386  determined that it has a sufficient number of Medicaid
 2387  participating providers. The agency must allow dispensing
 2388  practitioners to participate as a part of the Medicaid pharmacy
 2389  network regardless of the practitioner’s proximity to any other
 2390  entity that is dispensing prescription drugs under the Medicaid
 2391  program. A dispensing practitioner must meet all credentialing
 2392  requirements applicable to his or her practice, as determined by
 2393  the agency.
 2394         6.5. The agency shall develop and implement a program that
 2395  requires Medicaid practitioners who prescribe drugs to use a
 2396  counterfeit-proof prescription pad for Medicaid prescriptions.
 2397  The agency shall require the use of standardized counterfeit
 2398  proof prescription pads by Medicaid-participating prescribers or
 2399  prescribers who write prescriptions for Medicaid recipients. The
 2400  agency may implement the program in targeted geographic areas or
 2401  statewide.
 2402         7.6. The agency may enter into arrangements that require
 2403  manufacturers of generic drugs prescribed to Medicaid recipients
 2404  to provide rebates of at least 15.1 percent of the average
 2405  manufacturer price for the manufacturer’s generic products.
 2406  These arrangements shall require that if a generic-drug
 2407  manufacturer pays federal rebates for Medicaid-reimbursed drugs
 2408  at a level below 15.1 percent, the manufacturer must provide a
 2409  supplemental rebate to the state in an amount necessary to
 2410  achieve a 15.1-percent rebate level.
 2411         8.7. The agency may establish a preferred drug list as
 2412  described in this subsection, and, pursuant to the establishment
 2413  of such preferred drug list, it is authorized to negotiate
 2414  supplemental rebates from manufacturers that are in addition to
 2415  those required by Title XIX of the Social Security Act and at no
 2416  less than 14 percent of the average manufacturer price as
 2417  defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
 2418  the federal or supplemental rebate, or both, equals or exceeds
 2419  29 percent. There is no upper limit on the supplemental rebates
 2420  the agency may negotiate. The agency may determine that specific
 2421  products, brand-name or generic, are competitive at lower rebate
 2422  percentages. Agreement to pay the minimum supplemental rebate
 2423  percentage will guarantee a manufacturer that the Medicaid
 2424  Pharmaceutical and Therapeutics Committee will consider a
 2425  product for inclusion on the preferred drug list. However, a
 2426  pharmaceutical manufacturer is not guaranteed placement on the
 2427  preferred drug list by simply paying the minimum supplemental
 2428  rebate. Agency decisions will be made on the clinical efficacy
 2429  of a drug and recommendations of the Medicaid Pharmaceutical and
 2430  Therapeutics Committee, as well as the price of competing
 2431  products minus federal and state rebates. The agency is
 2432  authorized to contract with an outside agency or contractor to
 2433  conduct negotiations for supplemental rebates. For the purposes
 2434  of this section, the term “supplemental rebates” means cash
 2435  rebates. Effective July 1, 2004, value-added programs as a
 2436  substitution for supplemental rebates are prohibited. The agency
 2437  is authorized to seek any federal waivers to implement this
 2438  initiative.
 2439         9.8. The Agency for Health Care Administration shall expand
 2440  home delivery of pharmacy products. To assist Medicaid patients
 2441  in securing their prescriptions and reduce program costs, the
 2442  agency shall expand its current mail-order-pharmacy diabetes
 2443  supply program to include all generic and brand-name drugs used
 2444  by Medicaid patients with diabetes. Medicaid recipients in the
 2445  current program may obtain nondiabetes drugs on a voluntary
 2446  basis. This initiative is limited to the geographic area covered
 2447  by the current contract. The agency may seek and implement any
 2448  federal waivers necessary to implement this subparagraph.
 2449         10.9. The agency shall limit to one dose per month any drug
 2450  prescribed to treat erectile dysfunction.
 2451         11.10.a. The agency may implement a Medicaid behavioral
 2452  drug management system. The agency may contract with a vendor
 2453  that has experience in operating behavioral drug management
 2454  systems to implement this program. The agency is authorized to
 2455  seek federal waivers to implement this program.
 2456         b. The agency, in conjunction with the Department of
 2457  Children and Family Services, may implement the Medicaid
 2458  behavioral drug management system that is designed to improve
 2459  the quality of care and behavioral health prescribing practices
 2460  based on best practice guidelines, improve patient adherence to
 2461  medication plans, reduce clinical risk, and lower prescribed
 2462  drug costs and the rate of inappropriate spending on Medicaid
 2463  behavioral drugs. The program may include the following
 2464  elements:
 2465         (I) Provide for the development and adoption of best
 2466  practice guidelines for behavioral health-related drugs such as
 2467  antipsychotics, antidepressants, and medications for treating
 2468  bipolar disorders and other behavioral conditions; translate
 2469  them into practice; review behavioral health prescribers and
 2470  compare their prescribing patterns to a number of indicators
 2471  that are based on national standards; and determine deviations
 2472  from best practice guidelines.
 2473         (II) Implement processes for providing feedback to and
 2474  educating prescribers using best practice educational materials
 2475  and peer-to-peer consultation.
 2476         (III) Assess Medicaid beneficiaries who are outliers in
 2477  their use of behavioral health drugs with regard to the numbers
 2478  and types of drugs taken, drug dosages, combination drug
 2479  therapies, and other indicators of improper use of behavioral
 2480  health drugs.
 2481         (IV) Alert prescribers to patients who fail to refill
 2482  prescriptions in a timely fashion, are prescribed multiple same
 2483  class behavioral health drugs, and may have other potential
 2484  medication problems.
 2485         (V) Track spending trends for behavioral health drugs and
 2486  deviation from best practice guidelines.
 2487         (VI) Use educational and technological approaches to
 2488  promote best practices, educate consumers, and train prescribers
 2489  in the use of practice guidelines.
 2490         (VII) Disseminate electronic and published materials.
 2491         (VIII) Hold statewide and regional conferences.
 2492         (IX) Implement a disease management program with a model
 2493  quality-based medication component for severely mentally ill
 2494  individuals and emotionally disturbed children who are high
 2495  users of care.
 2496         12.11.a. The agency shall implement a Medicaid prescription
 2497  drug management system. The agency may contract with a vendor
 2498  that has experience in operating prescription drug management
 2499  systems in order to implement this system. Any management system
 2500  that is implemented in accordance with this subparagraph must
 2501  rely on cooperation between physicians and pharmacists to
 2502  determine appropriate practice patterns and clinical guidelines
 2503  to improve the prescribing, dispensing, and use of drugs in the
 2504  Medicaid program. The agency may seek federal waivers to
 2505  implement this program.
 2506         b. The drug management system must be designed to improve
 2507  the quality of care and prescribing practices based on best
 2508  practice guidelines, improve patient adherence to medication
 2509  plans, reduce clinical risk, and lower prescribed drug costs and
 2510  the rate of inappropriate spending on Medicaid prescription
 2511  drugs. The program must:
 2512         (I) Provide for the development and adoption of best
 2513  practice guidelines for the prescribing and use of drugs in the
 2514  Medicaid program, including translating best practice guidelines
 2515  into practice; reviewing prescriber patterns and comparing them
 2516  to indicators that are based on national standards and practice
 2517  patterns of clinical peers in their community, statewide, and
 2518  nationally; and determine deviations from best practice
 2519  guidelines.
 2520         (II) Implement processes for providing feedback to and
 2521  educating prescribers using best practice educational materials
 2522  and peer-to-peer consultation.
 2523         (III) Assess Medicaid recipients who are outliers in their
 2524  use of a single or multiple prescription drugs with regard to
 2525  the numbers and types of drugs taken, drug dosages, combination
 2526  drug therapies, and other indicators of improper use of
 2527  prescription drugs.
 2528         (IV) Alert prescribers to patients who fail to refill
 2529  prescriptions in a timely fashion, are prescribed multiple drugs
 2530  that may be redundant or contraindicated, or may have other
 2531  potential medication problems.
 2532         (V) Track spending trends for prescription drugs and
 2533  deviation from best practice guidelines.
 2534         (VI) Use educational and technological approaches to
 2535  promote best practices, educate consumers, and train prescribers
 2536  in the use of practice guidelines.
 2537         (VII) Disseminate electronic and published materials.
 2538         (VIII) Hold statewide and regional conferences.
 2539         (IX) Implement disease management programs in cooperation
 2540  with physicians and pharmacists, along with a model quality
 2541  based medication component for individuals having chronic
 2542  medical conditions.
 2543         13.12. The agency is authorized to contract for drug rebate
 2544  administration, including, but not limited to, calculating
 2545  rebate amounts, invoicing manufacturers, negotiating disputes
 2546  with manufacturers, and maintaining a database of rebate
 2547  collections.
 2548         14.13. The agency may specify the preferred daily dosing
 2549  form or strength for the purpose of promoting best practices
 2550  with regard to the prescribing of certain drugs as specified in
 2551  the General Appropriations Act and ensuring cost-effective
 2552  prescribing practices.
 2553         15.14. The agency may require prior authorization for
 2554  Medicaid-covered prescribed drugs. The agency may, but is not
 2555  required to, prior-authorize the use of a product:
 2556         a. For an indication not approved in labeling;
 2557         b. To comply with certain clinical guidelines; or
 2558         c. If the product has the potential for overuse, misuse, or
 2559  abuse.
 2560  
 2561  The agency may require the prescribing professional to provide
 2562  information about the rationale and supporting medical evidence
 2563  for the use of a drug. The agency may post prior authorization
 2564  criteria and protocol and updates to the list of drugs that are
 2565  subject to prior authorization on an Internet website without
 2566  amending its rule or engaging in additional rulemaking.
 2567         16.15. The agency, in conjunction with the Pharmaceutical
 2568  and Therapeutics Committee, may require age-related prior
 2569  authorizations for certain prescribed drugs. The agency may
 2570  preauthorize the use of a drug for a recipient who may not meet
 2571  the age requirement or may exceed the length of therapy for use
 2572  of this product as recommended by the manufacturer and approved
 2573  by the Food and Drug Administration. Prior authorization may
 2574  require the prescribing professional to provide information
 2575  about the rationale and supporting medical evidence for the use
 2576  of a drug.
 2577         17.16. The agency shall implement a step-therapy prior
 2578  authorization approval process for medications excluded from the
 2579  preferred drug list. Medications listed on the preferred drug
 2580  list must be used within the previous 12 months prior to the
 2581  alternative medications that are not listed. The step-therapy
 2582  prior authorization may require the prescriber to use the
 2583  medications of a similar drug class or for a similar medical
 2584  indication unless contraindicated in the Food and Drug
 2585  Administration labeling. The trial period between the specified
 2586  steps may vary according to the medical indication. The step
 2587  therapy approval process shall be developed in accordance with
 2588  the committee as stated in s. 409.91195(7) and (8). A drug
 2589  product may be approved without meeting the step-therapy prior
 2590  authorization criteria if the prescribing physician provides the
 2591  agency with additional written medical or clinical documentation
 2592  that the product is medically necessary because:
 2593         a. There is not a drug on the preferred drug list to treat
 2594  the disease or medical condition which is an acceptable clinical
 2595  alternative;
 2596         b. The alternatives have been ineffective in the treatment
 2597  of the beneficiary’s disease; or
 2598         c. Based on historic evidence and known characteristics of
 2599  the patient and the drug, the drug is likely to be ineffective,
 2600  or the number of doses have been ineffective.
 2601  
 2602  The agency shall work with the physician to determine the best
 2603  alternative for the patient. The agency may adopt rules waiving
 2604  the requirements for written clinical documentation for specific
 2605  drugs in limited clinical situations.
 2606         18.17. The agency shall implement a return and reuse
 2607  program for drugs dispensed by pharmacies to institutional
 2608  recipients, which includes payment of a $5 restocking fee for
 2609  the implementation and operation of the program. The return and
 2610  reuse program shall be implemented electronically and in a
 2611  manner that promotes efficiency. The program must permit a
 2612  pharmacy to exclude drugs from the program if it is not
 2613  practical or cost-effective for the drug to be included and must
 2614  provide for the return to inventory of drugs that cannot be
 2615  credited or returned in a cost-effective manner. The agency
 2616  shall determine if the program has reduced the amount of
 2617  Medicaid prescription drugs which are destroyed on an annual
 2618  basis and if there are additional ways to ensure more
 2619  prescription drugs are not destroyed which could safely be
 2620  reused. The agency’s conclusion and recommendations shall be
 2621  reported to the Legislature by December 1, 2005.
 2622         Section 68. Subsections (3) and (4) of section 429.07,
 2623  Florida Statutes, are amended, and subsections (6) and (7) are
 2624  added to that section, to read:
 2625         429.07 License required; fee; inspections.—
 2626         (3) In addition to the requirements of s. 408.806, each
 2627  license granted by the agency must state the type of care for
 2628  which the license is granted. Licenses shall be issued for one
 2629  or more of the following categories of care: standard, extended
 2630  congregate care, limited nursing services, or limited mental
 2631  health.
 2632         (a) A standard license shall be issued to a facility
 2633  facilities providing one or more of the personal services
 2634  identified in s. 429.02. Such licensee facilities may also
 2635  employ or contract with a person licensed under part I of
 2636  chapter 464 to administer medications and perform other tasks as
 2637  specified in s. 429.255.
 2638         (b) An extended congregate care license shall be issued to
 2639  a licensee facilities providing, directly or through contract,
 2640  services beyond those authorized in paragraph (a), including
 2641  acts performed pursuant to part I of chapter 464 by persons
 2642  licensed thereunder, and supportive services defined by rule to
 2643  persons who otherwise would be disqualified from continued
 2644  residence in a facility licensed under this part.
 2645         1. In order for extended congregate care services to be
 2646  provided in a facility licensed under this part, the agency must
 2647  first determine that all requirements established in law and
 2648  rule are met and must specifically designate, on the facility’s
 2649  license, that such services may be provided and whether the
 2650  designation applies to all or part of a facility. Such
 2651  designation may be made at the time of initial licensure or
 2652  relicensure, or upon request in writing by a licensee under this
 2653  part and part II of chapter 408. Notification of approval or
 2654  denial of such request shall be made in accordance with part II
 2655  of chapter 408. An existing licensee facilities qualifying to
 2656  provide extended congregate care services must have maintained a
 2657  standard license and may not have been subject to administrative
 2658  sanctions during the previous 2 years, or since initial
 2659  licensure if the facility has been licensed for less than 2
 2660  years, for any of the following reasons:
 2661         a. A class I or class II violation;
 2662         b. Three or more repeat or recurring class III violations
 2663  of identical or similar resident care standards as specified in
 2664  rule from which a pattern of noncompliance is found by the
 2665  agency;
 2666         c. Three or more class III violations that were not
 2667  corrected in accordance with the corrective action plan approved
 2668  by the agency;
 2669         d. Violation of resident care standards resulting in a
 2670  requirement to employ the services of a consultant pharmacist or
 2671  consultant dietitian;
 2672         e. Denial, suspension, or revocation of a license for
 2673  another facility under this part in which the applicant for an
 2674  extended congregate care license has at least 25 percent
 2675  ownership interest; or
 2676         f. Imposition of a moratorium pursuant to this part or part
 2677  II of chapter 408 or initiation of injunctive proceedings.
 2678         2. A licensee Facilities that is are licensed to provide
 2679  extended congregate care services shall maintain a written
 2680  progress report for on each person who receives such services,
 2681  and the which report must describe describes the type, amount,
 2682  duration, scope, and outcome of services that are rendered and
 2683  the general status of the resident’s health. A registered nurse,
 2684  or appropriate designee, representing the agency shall visit
 2685  such facilities at least quarterly to monitor residents who are
 2686  receiving extended congregate care services and to determine if
 2687  the facility is in compliance with this part, part II of chapter
 2688  408, and rules that relate to extended congregate care. One of
 2689  these visits may be in conjunction with the regular survey. The
 2690  monitoring visits may be provided through contractual
 2691  arrangements with appropriate community agencies. A registered
 2692  nurse shall serve as part of the team that inspects such
 2693  facility. The agency may waive one of the required yearly
 2694  monitoring visits for a facility that has been licensed for at
 2695  least 24 months to provide extended congregate care services,
 2696  if, during the inspection, the registered nurse determines that
 2697  extended congregate care services are being provided
 2698  appropriately, and if the facility has no class I or class II
 2699  violations and no uncorrected class III violations. Before such
 2700  decision is made, the agency shall consult with the long-term
 2701  care ombudsman council for the area in which the facility is
 2702  located to determine if any complaints have been made and
 2703  substantiated about the quality of services or care. The agency
 2704  may not waive one of the required yearly monitoring visits if
 2705  complaints have been made and substantiated.
 2706         3. Licensees Facilities that are licensed to provide
 2707  extended congregate care services shall:
 2708         a. Demonstrate the capability to meet unanticipated
 2709  resident service needs.
 2710         b. Offer a physical environment that promotes a homelike
 2711  setting, provides for resident privacy, promotes resident
 2712  independence, and allows sufficient congregate space as defined
 2713  by rule.
 2714         c. Have sufficient staff available, taking into account the
 2715  physical plant and firesafety features of the building, to
 2716  assist with the evacuation of residents in an emergency, as
 2717  necessary.
 2718         d. Adopt and follow policies and procedures that maximize
 2719  resident independence, dignity, choice, and decisionmaking to
 2720  permit residents to age in place to the extent possible, so that
 2721  moves due to changes in functional status are minimized or
 2722  avoided.
 2723         e. Allow residents or, if applicable, a resident’s
 2724  representative, designee, surrogate, guardian, or attorney in
 2725  fact to make a variety of personal choices, participate in
 2726  developing service plans, and share responsibility in
 2727  decisionmaking.
 2728         f. Implement the concept of managed risk.
 2729         g. Provide, either directly or through contract, the
 2730  services of a person licensed pursuant to part I of chapter 464.
 2731         h. In addition to the training mandated in s. 429.52,
 2732  provide specialized training as defined by rule for facility
 2733  staff.
 2734         4. Licensees Facilities licensed to provide extended
 2735  congregate care services are exempt from the criteria for
 2736  continued residency as set forth in rules adopted under s.
 2737  429.41. Licensees Facilities so licensed shall adopt their own
 2738  requirements within guidelines for continued residency set forth
 2739  by rule. However, such licensees facilities may not serve
 2740  residents who require 24-hour nursing supervision. Licensees
 2741  Facilities licensed to provide extended congregate care services
 2742  shall provide each resident with a written copy of facility
 2743  policies governing admission and retention.
 2744         5. The primary purpose of extended congregate care services
 2745  is to allow residents, as they become more impaired, the option
 2746  of remaining in a familiar setting from which they would
 2747  otherwise be disqualified for continued residency. A facility
 2748  licensed to provide extended congregate care services may also
 2749  admit an individual who exceeds the admission criteria for a
 2750  facility with a standard license, if the individual is
 2751  determined appropriate for admission to the extended congregate
 2752  care facility.
 2753         6. Before admission of an individual to a facility licensed
 2754  to provide extended congregate care services, the individual
 2755  must undergo a medical examination as provided in s. 429.26(4)
 2756  and the facility must develop a preliminary service plan for the
 2757  individual.
 2758         7. When a licensee facility can no longer provide or
 2759  arrange for services in accordance with the resident’s service
 2760  plan and needs and the licensee’s facility’s policy, the
 2761  licensee facility shall make arrangements for relocating the
 2762  person in accordance with s. 429.28(1)(k).
 2763         8. Failure to provide extended congregate care services may
 2764  result in denial of extended congregate care license renewal.
 2765         9.No later than January 1 of each year, the department, in
 2766  consultation with the agency, shall prepare and submit to the
 2767  Governor, the President of the Senate, the Speaker of the House
 2768  of Representatives, and the chairs of appropriate legislative
 2769  committees, a report on the status of, and recommendations
 2770  related to, extended congregate care services. The status report
 2771  must include, but need not be limited to, the following
 2772  information:
 2773         a.A description of the facilities licensed to provide such
 2774  services, including total number of beds licensed under this
 2775  part.
 2776         b.The number and characteristics of residents receiving
 2777  such services.
 2778         c.The types of services rendered that could not be
 2779  provided through a standard license.
 2780         d.An analysis of deficiencies cited during licensure
 2781  inspections.
 2782         e.The number of residents who required extended congregate
 2783  care services at admission and the source of admission.
 2784         f.Recommendations for statutory or regulatory changes.
 2785         g.The availability of extended congregate care to state
 2786  clients residing in facilities licensed under this part and in
 2787  need of additional services, and recommendations for
 2788  appropriations to subsidize extended congregate care services
 2789  for such persons.
 2790         h.Such other information as the department considers
 2791  appropriate.
 2792         (c)A limited nursing services license shall be issued to a
 2793  facility that provides services beyond those authorized in
 2794  paragraph (a) and as specified in this paragraph.
 2795         1.In order for limited nursing services to be provided in
 2796  a facility licensed under this part, the agency must first
 2797  determine that all requirements established in law and rule are
 2798  met and must specifically designate, on the facility’s license,
 2799  that such services may be provided. Such designation may be made
 2800  at the time of initial licensure or relicensure, or upon request
 2801  in writing by a licensee under this part and part II of chapter
 2802  408. Notification of approval or denial of such request shall be
 2803  made in accordance with part II of chapter 408. Existing
 2804  facilities qualifying to provide limited nursing services shall
 2805  have maintained a standard license and may not have been subject
 2806  to administrative sanctions that affect the health, safety, and
 2807  welfare of residents for the previous 2 years or since initial
 2808  licensure if the facility has been licensed for less than 2
 2809  years.
 2810         2.Facilities that are licensed to provide limited nursing
 2811  services shall maintain a written progress report on each person
 2812  who receives such nursing services, which report describes the
 2813  type, amount, duration, scope, and outcome of services that are
 2814  rendered and the general status of the resident’s health. A
 2815  registered nurse representing the agency shall visit such
 2816  facilities at least twice a year to monitor residents who are
 2817  receiving limited nursing services and to determine if the
 2818  facility is in compliance with applicable provisions of this
 2819  part, part II of chapter 408, and related rules. The monitoring
 2820  visits may be provided through contractual arrangements with
 2821  appropriate community agencies. A registered nurse shall also
 2822  serve as part of the team that inspects such facility.
 2823         3.A person who receives limited nursing services under
 2824  this part must meet the admission criteria established by the
 2825  agency for assisted living facilities. When a resident no longer
 2826  meets the admission criteria for a facility licensed under this
 2827  part, arrangements for relocating the person shall be made in
 2828  accordance with s. 429.28(1)(k), unless the facility is licensed
 2829  to provide extended congregate care services.
 2830         (4) In accordance with s. 408.805, an applicant or licensee
 2831  shall pay a fee for each license application submitted under
 2832  this part, part II of chapter 408, and applicable rules. The
 2833  amount of the fee shall be established by rule.
 2834         (a) The biennial license fee required of a facility is $356
 2835  $300 per license, with an additional fee of $67.50 $50 per
 2836  resident based on the total licensed resident capacity of the
 2837  facility, except that no additional fee will be assessed for
 2838  beds designated for recipients of optional state supplementation
 2839  payments provided for in s. 409.212. The total fee may not
 2840  exceed $18,000 $10,000.
 2841         (b) In addition to the total fee assessed under paragraph
 2842  (a), the agency shall require facilities that are licensed to
 2843  provide extended congregate care services under this part to pay
 2844  an additional fee per licensed facility. The amount of the
 2845  biennial fee shall be $501 $400 per license, with an additional
 2846  fee of $10 per resident based on the total licensed resident
 2847  capacity of the facility.
 2848         (c)In addition to the total fee assessed under paragraph
 2849  (a), the agency shall require facilities that are licensed to
 2850  provide limited nursing services under this part to pay an
 2851  additional fee per licensed facility. The amount of the biennial
 2852  fee shall be $250 per license, with an additional fee of $10 per
 2853  resident based on the total licensed resident capacity of the
 2854  facility.
 2855         (6)In order to determine whether the facility is
 2856  adequately protecting residents’ rights as provided in s.
 2857  429.28, the biennial survey shall include private informal
 2858  conversations with a sample of residents and consultation with
 2859  the ombudsman council in the planning and service area in which
 2860  the facility is located to discuss residents’ experiences within
 2861  the facility.
 2862         (7)An assisted living facility that has been cited within
 2863  the previous 24-month period for a class I or class II
 2864  violation, regardless of the status of any enforcement or
 2865  disciplinary action, is subject to periodic unannounced
 2866  monitoring to determine if the facility is in compliance with
 2867  this part, part II of chapter 408, and applicable rules.
 2868  Monitoring may occur through a desk review or an onsite
 2869  assessment. If the class I or class II violation relates to
 2870  providing or failing to provide nursing care, a registered nurse
 2871  must participate in at least two onsite monitoring visits within
 2872  a 12-month period.
 2873         Section 69. Subsection (7) of section 429.11, Florida
 2874  Statutes, is renumbered as subsection (6), and present
 2875  subsection (6) of that section is amended to read:
 2876         429.11 Initial application for license; provisional
 2877  license.—
 2878         (6)In addition to the license categories available in s.
 2879  408.808, a provisional license may be issued to an applicant
 2880  making initial application for licensure or making application
 2881  for a change of ownership. A provisional license shall be
 2882  limited in duration to a specific period of time not to exceed 6
 2883  months, as determined by the agency.
 2884         Section 70. Section 429.12, Florida Statutes, is amended to
 2885  read:
 2886         429.12 Sale or transfer of ownership of a facility.—It is
 2887  the intent of the Legislature to protect the rights of the
 2888  residents of an assisted living facility when the facility is
 2889  sold or the ownership thereof is transferred. Therefore, in
 2890  addition to the requirements of part II of chapter 408, whenever
 2891  a facility is sold or the ownership thereof is transferred,
 2892  including leasing:.
 2893         (1) The transferee shall notify the residents, in writing,
 2894  of the change of ownership within 7 days after receipt of the
 2895  new license.
 2896         (2)The transferor of a facility the license of which is
 2897  denied pending an administrative hearing shall, as a part of the
 2898  written change-of-ownership contract, advise the transferee that
 2899  a plan of correction must be submitted by the transferee and
 2900  approved by the agency at least 7 days before the change of
 2901  ownership and that failure to correct the condition which
 2902  resulted in the moratorium pursuant to part II of chapter 408 or
 2903  denial of licensure is grounds for denial of the transferee’s
 2904  license.
 2905         Section 71. Paragraphs (b) through (l) of subsection (1) of
 2906  section 429.14, Florida Statutes, are redesignated as paragraphs
 2907  (a) through (k), respectively, and present paragraph (a) of
 2908  subsection (1) and subsections (5) and (6) of that section are
 2909  amended to read:
 2910         429.14 Administrative penalties.—
 2911         (1) In addition to the requirements of part II of chapter
 2912  408, the agency may deny, revoke, and suspend any license issued
 2913  under this part and impose an administrative fine in the manner
 2914  provided in chapter 120 against a licensee of an assisted living
 2915  facility for a violation of any provision of this part, part II
 2916  of chapter 408, or applicable rules, or for any of the following
 2917  actions by a licensee of an assisted living facility, for the
 2918  actions of any person subject to level 2 background screening
 2919  under s. 408.809, or for the actions of any facility employee:
 2920         (a)An intentional or negligent act seriously affecting the
 2921  health, safety, or welfare of a resident of the facility.
 2922         (5) An action taken by the agency to suspend, deny, or
 2923  revoke a facility’s license under this part or part II of
 2924  chapter 408, in which the agency claims that the facility owner
 2925  or an employee of the facility has threatened the health,
 2926  safety, or welfare of a resident of the facility shall be heard
 2927  by the Division of Administrative Hearings of the Department of
 2928  Management Services within 120 days after receipt of the
 2929  facility’s request for a hearing, unless that time limitation is
 2930  waived by both parties. The administrative law judge must render
 2931  a decision within 30 days after receipt of a proposed
 2932  recommended order.
 2933         (6) The agency shall provide to the Division of Hotels and
 2934  Restaurants of the Department of Business and Professional
 2935  Regulation, on a monthly basis, a list of those assisted living
 2936  facilities that have had their licenses denied, suspended, or
 2937  revoked or that are involved in an appellate proceeding pursuant
 2938  to s. 120.60 related to the denial, suspension, or revocation of
 2939  a license. This information may be provided electronically or
 2940  through the agency’s Internet website.
 2941         Section 72. Subsections (1), (4), and (5) of section
 2942  429.17, Florida Statutes, are amended to read:
 2943         429.17 Expiration of license; renewal; conditional
 2944  license.—
 2945         (1) Limited nursing, Extended congregate care, and limited
 2946  mental health licenses shall expire at the same time as the
 2947  facility’s standard license, regardless of when issued.
 2948         (4) In addition to the license categories available in s.
 2949  408.808, a conditional license may be issued to an applicant for
 2950  license renewal if the applicant fails to meet all standards and
 2951  requirements for licensure. A conditional license issued under
 2952  this subsection shall be limited in duration to a specific
 2953  period of time not to exceed 6 months, as determined by the
 2954  agency, and shall be accompanied by an agency-approved plan of
 2955  correction.
 2956         (5) When an extended congregate care or limited nursing
 2957  license is requested during a facility’s biennial license
 2958  period, the fee shall be prorated in order to permit the
 2959  additional license to expire at the end of the biennial license
 2960  period. The fee shall be calculated as of the date the
 2961  additional license application is received by the agency.
 2962         Section 73. Subsection (7) of section 429.19, Florida
 2963  Statutes, is amended to read:
 2964         429.19 Violations; imposition of administrative fines;
 2965  grounds.—
 2966         (7) In addition to any administrative fines imposed, the
 2967  agency may assess a survey or monitoring fee, equal to the
 2968  lesser of one half of the facility’s biennial license and bed
 2969  fee or $500, to cover the cost of conducting initial complaint
 2970  investigations that result in the finding of a violation that
 2971  was the subject of the complaint or to monitor the health,
 2972  safety, or security of residents under s. 429.07(7) monitoring
 2973  visits conducted under s. 429.28(3)(c) to verify the correction
 2974  of the violations.
 2975         Section 74. Subsections (6) through (10) of section 429.23,
 2976  Florida Statutes, are renumbered as subsections (5) through (9),
 2977  respectively, and present subsection (5) of that section is
 2978  amended to read:
 2979         429.23 Internal risk management and quality assurance
 2980  program; adverse incidents and reporting requirements.—
 2981         (5)Each facility shall report monthly to the agency any
 2982  liability claim filed against it. The report must include the
 2983  name of the resident, the dates of the incident leading to the
 2984  claim, if applicable, and the type of injury or violation of
 2985  rights alleged to have occurred. This report is not discoverable
 2986  in any civil or administrative action, except in such actions
 2987  brought by the agency to enforce the provisions of this part.
 2988         Section 75. Paragraph (a) of subsection (1) and subsection
 2989  (2) of section 429.255, Florida Statutes, are amended to read:
 2990         429.255 Use of personnel; emergency care.—
 2991         (1)(a) Persons under contract to the facility or, facility
 2992  staff, or volunteers, who are licensed according to part I of
 2993  chapter 464, or those persons exempt under s. 464.022(1), and
 2994  others as defined by rule, may administer medications to
 2995  residents, take residents’ vital signs, manage individual weekly
 2996  pill organizers for residents who self-administer medication,
 2997  give prepackaged enemas ordered by a physician, observe
 2998  residents, document observations on the appropriate resident’s
 2999  record, report observations to the resident’s physician, and
 3000  contract or allow residents or a resident’s representative,
 3001  designee, surrogate, guardian, or attorney in fact to contract
 3002  with a third party, provided residents meet the criteria for
 3003  appropriate placement as defined in s. 429.26. Persons under
 3004  contract to the facility or facility staff who are licensed
 3005  according to part I of chapter 464 may provide limited nursing
 3006  services. Nursing assistants certified pursuant to part II of
 3007  chapter 464 may take residents’ vital signs as directed by a
 3008  licensed nurse or physician. The facility is responsible for
 3009  maintaining documentation of services provided under this
 3010  paragraph as required by rule and ensuring that staff are
 3011  adequately trained to monitor residents receiving these
 3012  services.
 3013         (2) In facilities licensed to provide extended congregate
 3014  care, persons under contract to the facility or, facility staff,
 3015  or volunteers, who are licensed according to part I of chapter
 3016  464, or those persons exempt under s. 464.022(1), or those
 3017  persons certified as nursing assistants pursuant to part II of
 3018  chapter 464, may also perform all duties within the scope of
 3019  their license or certification, as approved by the facility
 3020  administrator and pursuant to this part.
 3021         Section 76. Subsection (3) of section 429.28, Florida
 3022  Statutes, is amended to read:
 3023         429.28 Resident bill of rights.—
 3024         (3)(a)The agency shall conduct a survey to determine
 3025  general compliance with facility standards and compliance with
 3026  residents’ rights as a prerequisite to initial licensure or
 3027  licensure renewal.
 3028         (b)In order to determine whether the facility is
 3029  adequately protecting residents’ rights, the biennial survey
 3030  shall include private informal conversations with a sample of
 3031  residents and consultation with the ombudsman council in the
 3032  planning and service area in which the facility is located to
 3033  discuss residents’ experiences within the facility.
 3034         (c)During any calendar year in which no survey is
 3035  conducted, the agency shall conduct at least one monitoring
 3036  visit of each facility cited in the previous year for a class I
 3037  or class II violation, or more than three uncorrected class III
 3038  violations.
 3039         (d)The agency may conduct periodic followup inspections as
 3040  necessary to monitor the compliance of facilities with a history
 3041  of any class I, class II, or class III violations that threaten
 3042  the health, safety, or security of residents.
 3043         (e)The agency may conduct complaint investigations as
 3044  warranted to investigate any allegations of noncompliance with
 3045  requirements required under this part or rules adopted under
 3046  this part.
 3047         Section 77. Subsection (2) of section 429.35, Florida
 3048  Statutes, is amended to read:
 3049         429.35 Maintenance of records; reports.—
 3050         (2) Within 60 days after the date of the biennial
 3051  inspection visit required under s. 408.811 or within 30 days
 3052  after the date of any interim visit, the agency shall forward
 3053  the results of the inspection to the local ombudsman council in
 3054  whose planning and service area, as defined in part II of
 3055  chapter 400, the facility is located; to at least one public
 3056  library or, in the absence of a public library, the county seat
 3057  in the county in which the inspected assisted living facility is
 3058  located; and, when appropriate, to the district Adult Services
 3059  and Mental Health Program Offices. This information may be
 3060  provided electronically or through the agency’s Internet
 3061  website.
 3062         Section 78. Paragraphs (i) and (j) of subsection (1) of
 3063  section 429.41, Florida Statutes, are amended to read:
 3064         429.41 Rules establishing standards.—
 3065         (1) It is the intent of the Legislature that rules
 3066  published and enforced pursuant to this section shall include
 3067  criteria by which a reasonable and consistent quality of
 3068  resident care and quality of life may be ensured and the results
 3069  of such resident care may be demonstrated. Such rules shall also
 3070  ensure a safe and sanitary environment that is residential and
 3071  noninstitutional in design or nature. It is further intended
 3072  that reasonable efforts be made to accommodate the needs and
 3073  preferences of residents to enhance the quality of life in a
 3074  facility. The agency, in consultation with the department, may
 3075  adopt rules to administer the requirements of part II of chapter
 3076  408. In order to provide safe and sanitary facilities and the
 3077  highest quality of resident care accommodating the needs and
 3078  preferences of residents, the department, in consultation with
 3079  the agency, the Department of Children and Family Services, and
 3080  the Department of Health, shall adopt rules, policies, and
 3081  procedures to administer this part, which must include
 3082  reasonable and fair minimum standards in relation to:
 3083         (i) Facilities holding an a limited nursing, extended
 3084  congregate care, or limited mental health license.
 3085         (j) The establishment of specific criteria to define
 3086  appropriateness of resident admission and continued residency in
 3087  a facility holding a standard, limited nursing, extended
 3088  congregate care, and limited mental health license.
 3089         Section 79. Subsections (1) and (2) of section 429.53,
 3090  Florida Statutes, are amended to read:
 3091         429.53 Consultation by the agency.—
 3092         (1) The area offices of licensure and certification of the
 3093  agency shall provide consultation to the following upon request:
 3094         (a) A licensee of a facility.
 3095         (b) A person interested in obtaining a license to operate a
 3096  facility under this part.
 3097         (2) As used in this section, “consultation” includes:
 3098         (a) An explanation of the requirements of this part and
 3099  rules adopted pursuant thereto;
 3100         (b) An explanation of the license application and renewal
 3101  procedures;
 3102         (c)The provision of a checklist of general local and state
 3103  approvals required prior to constructing or developing a
 3104  facility and a listing of the types of agencies responsible for
 3105  such approvals;
 3106         (d)An explanation of benefits and financial assistance
 3107  available to a recipient of supplemental security income
 3108  residing in a facility;
 3109         (c)(e) Any other information which the agency deems
 3110  necessary to promote compliance with the requirements of this
 3111  part; and
 3112         (f)A preconstruction review of a facility to ensure
 3113  compliance with agency rules and this part.
 3114         Section 80. Subsections (1) and (2) of section 429.54,
 3115  Florida Statutes, are renumbered as subsections (2) and (3),
 3116  respectively, and a new subsection (1) is added to that section
 3117  to read:
 3118         429.54 Collection of information; local subsidy.—
 3119         (1)A facility that is licensed under this part must report
 3120  electronically to the agency semiannually data related to the
 3121  facility, including, but not limited to, the total number of
 3122  residents, the number of residents who are receiving limited
 3123  mental health services, the number of residents who are
 3124  receiving extended congregate care services, the number of
 3125  residents who are receiving limited nursing services, and
 3126  professional staffing employed by or under contract with the
 3127  licensee to provide resident services. The department, in
 3128  consultation with the agency, shall adopt rules to administer
 3129  this subsection.
 3130         Section 81. Subsections (1) and (5) of section 429.71,
 3131  Florida Statutes, are amended to read:
 3132         429.71 Classification of violations deficiencies;
 3133  administrative fines.—
 3134         (1) In addition to the requirements of part II of chapter
 3135  408 and in addition to any other liability or penalty provided
 3136  by law, the agency may impose an administrative fine on a
 3137  provider according to the following classification:
 3138         (a) Class I violations are defined in s. 408.813 those
 3139  conditions or practices related to the operation and maintenance
 3140  of an adult family-care home or to the care of residents which
 3141  the agency determines present an imminent danger to the
 3142  residents or guests of the facility or a substantial probability
 3143  that death or serious physical or emotional harm would result
 3144  therefrom. The condition or practice that constitutes a class I
 3145  violation must be abated or eliminated within 24 hours, unless a
 3146  fixed period, as determined by the agency, is required for
 3147  correction. A class I violation deficiency is subject to an
 3148  administrative fine in an amount not less than $500 and not
 3149  exceeding $1,000 for each violation. A fine may be levied
 3150  notwithstanding the correction of the deficiency.
 3151         (b) Class II violations are defined in s. 408.813 those
 3152  conditions or practices related to the operation and maintenance
 3153  of an adult family-care home or to the care of residents which
 3154  the agency determines directly threaten the physical or
 3155  emotional health, safety, or security of the residents, other
 3156  than class I violations. A class II violation is subject to an
 3157  administrative fine in an amount not less than $250 and not
 3158  exceeding $500 for each violation. A citation for a class II
 3159  violation must specify the time within which the violation is
 3160  required to be corrected. If a class II violation is corrected
 3161  within the time specified, no civil penalty shall be imposed,
 3162  unless it is a repeated offense.
 3163         (c) Class III violations are defined in s. 408.813 those
 3164  conditions or practices related to the operation and maintenance
 3165  of an adult family-care home or to the care of residents which
 3166  the agency determines indirectly or potentially threaten the
 3167  physical or emotional health, safety, or security of residents,
 3168  other than class I or class II violations. A class III violation
 3169  is subject to an administrative fine in an amount not less than
 3170  $100 and not exceeding $250 for each violation. A citation for a
 3171  class III violation shall specify the time within which the
 3172  violation is required to be corrected. If a class III violation
 3173  is corrected within the time specified, no civil penalty shall
 3174  be imposed, unless it is a repeated violation offense.
 3175         (d) Class IV violations are defined in s. 408.813 those
 3176  conditions or occurrences related to the operation and
 3177  maintenance of an adult family-care home, or related to the
 3178  required reports, forms, or documents, which do not have the
 3179  potential of negatively affecting the residents. A provider that
 3180  does not correct A class IV violation within the time limit
 3181  specified by the agency is subject to an administrative fine in
 3182  an amount not less than $50 and not exceeding $100 for each
 3183  violation. Any class IV violation that is corrected during the
 3184  time the agency survey is conducted will be identified as an
 3185  agency finding and not as a violation, unless it is a repeat
 3186  violation.
 3187         (5)As an alternative to or in conjunction with an
 3188  administrative action against a provider, the agency may request
 3189  a plan of corrective action that demonstrates a good faith
 3190  effort to remedy each violation by a specific date, subject to
 3191  the approval of the agency.
 3192         Section 82. Paragraphs (b) through (e) of subsection (2) of
 3193  section 429.911, Florida Statutes, are redesignated as
 3194  paragraphs (a) through (d), respectively, and present paragraph
 3195  (a) of that subsection is amended to read:
 3196         429.911 Denial, suspension, revocation of license;
 3197  emergency action; administrative fines; investigations and
 3198  inspections.—
 3199         (2) Each of the following actions by the owner of an adult
 3200  day care center or by its operator or employee is a ground for
 3201  action by the agency against the owner of the center or its
 3202  operator or employee:
 3203         (a)An intentional or negligent act materially affecting
 3204  the health or safety of center participants.
 3205         Section 83. Section 429.915, Florida Statutes, is amended
 3206  to read:
 3207         429.915 Conditional license.—In addition to the license
 3208  categories available in part II of chapter 408, the agency may
 3209  issue a conditional license to an applicant for license renewal
 3210  or change of ownership if the applicant fails to meet all
 3211  standards and requirements for licensure. A conditional license
 3212  issued under this subsection must be limited to a specific
 3213  period not exceeding 6 months, as determined by the agency, and
 3214  must be accompanied by an approved plan of correction.
 3215         Section 84. Paragraphs (b) and (h) of subsection (3) of
 3216  section 430.80, Florida Statutes, are amended to read:
 3217         430.80 Implementation of a teaching nursing home pilot
 3218  project.—
 3219         (3) To be designated as a teaching nursing home, a nursing
 3220  home licensee must, at a minimum:
 3221         (b) Participate in a nationally recognized accreditation
 3222  program and hold a valid accreditation, such as the
 3223  accreditation awarded by The Joint Commission on Accreditation
 3224  of Healthcare Organizations;
 3225         (h) Maintain insurance coverage pursuant to s.
 3226  400.141(1)(q)(s) or proof of financial responsibility in a
 3227  minimum amount of $750,000. Such proof of financial
 3228  responsibility may include:
 3229         1. Maintaining an escrow account consisting of cash or
 3230  assets eligible for deposit in accordance with s. 625.52; or
 3231         2. Obtaining and maintaining pursuant to chapter 675 an
 3232  unexpired, irrevocable, nontransferable and nonassignable letter
 3233  of credit issued by any bank or savings association organized
 3234  and existing under the laws of this state or any bank or savings
 3235  association organized under the laws of the United States that
 3236  has its principal place of business in this state or has a
 3237  branch office which is authorized to receive deposits in this
 3238  state. The letter of credit shall be used to satisfy the
 3239  obligation of the facility to the claimant upon presentment of a
 3240  final judgment indicating liability and awarding damages to be
 3241  paid by the facility or upon presentment of a settlement
 3242  agreement signed by all parties to the agreement when such final
 3243  judgment or settlement is a result of a liability claim against
 3244  the facility.
 3245         Section 85. Paragraph (a) of subsection (2) of section
 3246  440.13, Florida Statutes, is amended to read:
 3247         440.13 Medical services and supplies; penalty for
 3248  violations; limitations.—
 3249         (2) MEDICAL TREATMENT; DUTY OF EMPLOYER TO FURNISH.—
 3250         (a) Subject to the limitations specified elsewhere in this
 3251  chapter, the employer shall furnish to the employee such
 3252  medically necessary remedial treatment, care, and attendance for
 3253  such period as the nature of the injury or the process of
 3254  recovery may require, which is in accordance with established
 3255  practice parameters and protocols of treatment as provided for
 3256  in this chapter, including medicines, medical supplies, durable
 3257  medical equipment, orthoses, prostheses, and other medically
 3258  necessary apparatus. Remedial treatment, care, and attendance,
 3259  including work-hardening programs or pain-management programs
 3260  accredited by the Commission on Accreditation of Rehabilitation
 3261  Facilities or The Joint Commission on the Accreditation of
 3262  Health Organizations or pain-management programs affiliated with
 3263  medical schools, shall be considered as covered treatment only
 3264  when such care is given based on a referral by a physician as
 3265  defined in this chapter. Medically necessary treatment, care,
 3266  and attendance does not include chiropractic services in excess
 3267  of 24 treatments or rendered 12 weeks beyond the date of the
 3268  initial chiropractic treatment, whichever comes first, unless
 3269  the carrier authorizes additional treatment or the employee is
 3270  catastrophically injured.
 3271  
 3272  Failure of the carrier to timely comply with this subsection
 3273  shall be a violation of this chapter and the carrier shall be
 3274  subject to penalties as provided for in s. 440.525.
 3275         Section 86. Subsection (11) is added to section 483.201,
 3276  Florida Statutes, to read:
 3277         483.201 Grounds for disciplinary action against clinical
 3278  laboratories.—In addition to the requirements of part II of
 3279  chapter 408, the following acts constitute grounds for which a
 3280  disciplinary action specified in s. 483.221 may be taken against
 3281  a clinical laboratory:
 3282         (11) A blood establishment that collects blood or blood
 3283  components from volunteer donors failing to disclose information
 3284  concerning its activities as required by s. 381.06014. Each day
 3285  of violation constitutes a separate violation and each separate
 3286  violation is subject to a separate fine. If multiple licensed
 3287  establishments operated by a single business entity fail to meet
 3288  such disclosure requirements, the agency may assess fines
 3289  against only one of the business entity’s clinical laboratory
 3290  licenses. The total administrative fine may not exceed $10,000
 3291  for each annual reporting period.
 3292         Section 87. Section 483.294, Florida Statutes, is amended
 3293  to read:
 3294         483.294 Inspection of centers.—In accordance with s.
 3295  408.811, the agency shall biennially, at least once annually,
 3296  inspect the premises and operations of all centers subject to
 3297  licensure under this part.
 3298         Section 88. Subsection (23) and paragraph (a) of subsection
 3299  (53) of section 499.003, Florida Statutes, are amended to read:
 3300         499.003 Definitions of terms used in this part.—As used in
 3301  this part, the term:
 3302         (23) “Health care entity” means a closed pharmacy or any
 3303  person, organization, or business entity that provides
 3304  diagnostic, medical, surgical, or dental treatment or care, or
 3305  chronic or rehabilitative care, but does not include any
 3306  wholesale distributor or retail pharmacy licensed under state
 3307  law to deal in prescription drugs. However, a blood
 3308  establishment may be a health care entity and engage in the
 3309  wholesale distribution of prescription drugs under s.
 3310  499.01(2)(g)1.c.
 3311         (53) “Wholesale distribution” means distribution of
 3312  prescription drugs to persons other than a consumer or patient,
 3313  but does not include:
 3314         (a) Any of the following activities, which is not a
 3315  violation of s. 499.005(21) if such activity is conducted in
 3316  accordance with s. 499.01(2)(g):
 3317         1. The purchase or other acquisition by a hospital or other
 3318  health care entity that is a member of a group purchasing
 3319  organization of a prescription drug for its own use from the
 3320  group purchasing organization or from other hospitals or health
 3321  care entities that are members of that organization.
 3322         2. The sale, purchase, or trade of a prescription drug or
 3323  an offer to sell, purchase, or trade a prescription drug by a
 3324  charitable organization described in s. 501(c)(3) of the
 3325  Internal Revenue Code of 1986, as amended and revised, to a
 3326  nonprofit affiliate of the organization to the extent otherwise
 3327  permitted by law.
 3328         3. The sale, purchase, or trade of a prescription drug or
 3329  an offer to sell, purchase, or trade a prescription drug among
 3330  hospitals or other health care entities that are under common
 3331  control. For purposes of this subparagraph, “common control”
 3332  means the power to direct or cause the direction of the
 3333  management and policies of a person or an organization, whether
 3334  by ownership of stock, by voting rights, by contract, or
 3335  otherwise.
 3336         4. The sale, purchase, trade, or other transfer of a
 3337  prescription drug from or for any federal, state, or local
 3338  government agency or any entity eligible to purchase
 3339  prescription drugs at public health services prices pursuant to
 3340  Pub. L. No. 102-585, s. 602 to a contract provider or its
 3341  subcontractor for eligible patients of the agency or entity
 3342  under the following conditions:
 3343         a. The agency or entity must obtain written authorization
 3344  for the sale, purchase, trade, or other transfer of a
 3345  prescription drug under this subparagraph from the State Surgeon
 3346  General or his or her designee.
 3347         b. The contract provider or subcontractor must be
 3348  authorized by law to administer or dispense prescription drugs.
 3349         c. In the case of a subcontractor, the agency or entity
 3350  must be a party to and execute the subcontract.
 3351         d. A contract provider or subcontractor must maintain
 3352  separate and apart from other prescription drug inventory any
 3353  prescription drugs of the agency or entity in its possession.
 3354         d.e. The contract provider and subcontractor must maintain
 3355  and produce immediately for inspection all records of movement
 3356  or transfer of all the prescription drugs belonging to the
 3357  agency or entity, including, but not limited to, the records of
 3358  receipt and disposition of prescription drugs. Each contractor
 3359  and subcontractor dispensing or administering these drugs must
 3360  maintain and produce records documenting the dispensing or
 3361  administration. Records that are required to be maintained
 3362  include, but are not limited to, a perpetual inventory itemizing
 3363  drugs received and drugs dispensed by prescription number or
 3364  administered by patient identifier, which must be submitted to
 3365  the agency or entity quarterly.
 3366         e.f. The contract provider or subcontractor may administer
 3367  or dispense the prescription drugs only to the eligible patients
 3368  of the agency or entity or must return the prescription drugs
 3369  for or to the agency or entity. The contract provider or
 3370  subcontractor must require proof from each person seeking to
 3371  fill a prescription or obtain treatment that the person is an
 3372  eligible patient of the agency or entity and must, at a minimum,
 3373  maintain a copy of this proof as part of the records of the
 3374  contractor or subcontractor required under sub-subparagraph d.
 3375  e.
 3376         f.g. In addition to the departmental inspection authority
 3377  set forth in s. 499.051, the establishment of the contract
 3378  provider and subcontractor and all records pertaining to
 3379  prescription drugs subject to this subparagraph shall be subject
 3380  to inspection by the agency or entity. All records relating to
 3381  prescription drugs of a manufacturer under this subparagraph
 3382  shall be subject to audit by the manufacturer of those drugs,
 3383  without identifying individual patient information.
 3384         Section 89. Subsection (21) of section 499.005, Florida
 3385  Statutes, is amended to read:
 3386         499.005 Prohibited acts.—It is unlawful for a person to
 3387  perform or cause the performance of any of the following acts in
 3388  this state:
 3389         (21) The wholesale distribution of any prescription drug
 3390  that was:
 3391         (a) Purchased by a public or private hospital or other
 3392  health care entity, except as authorized in s. 499.01(2)(g)1.c.;
 3393  or
 3394         (b) Donated or supplied at a reduced price to a charitable
 3395  organization.
 3396         Section 90. Paragraphs (a) and (g) of subsection (2) of
 3397  section 499.01, Florida Statutes, are amended to read:
 3398         499.01 Permits.—
 3399         (2) The following permits are established:
 3400         (a) Prescription drug manufacturer permit.—A prescription
 3401  drug manufacturer permit is required for any person that is a
 3402  manufacturer of a prescription drug and that manufactures or
 3403  distributes such prescription drugs in this state.
 3404         1. A person that operates an establishment permitted as a
 3405  prescription drug manufacturer may engage in wholesale
 3406  distribution of prescription drugs manufactured at that
 3407  establishment and must comply with all of the provisions of this
 3408  part, except s. 499.01212, and the rules adopted under this
 3409  part, except s. 499.01212, that apply to a wholesale
 3410  distributor.
 3411         2. A prescription drug manufacturer must comply with all
 3412  appropriate state and federal good manufacturing practices.
 3413         3. A blood establishment as defined in s. 381.06014,
 3414  operating in a manner consistent with the provisions of Title 21
 3415  C.F.R. Parts 211 and 600-640, and manufacturing only the
 3416  prescription drugs described in s. 499.003(53)(d) is not
 3417  required to be permitted as a prescription drug manufacturer
 3418  under this paragraph or register products under s. 499.015.
 3419         (g) Restricted prescription drug distributor permit.—
 3420         1. A restricted prescription drug distributor permit is
 3421  required for:
 3422         a. Any person that engages in the distribution of a
 3423  prescription drug, which distribution is not considered
 3424  “wholesale distribution” under s. 499.003(53)(a).
 3425         b.1.Any A person who engages in the receipt or
 3426  distribution of a prescription drug in this state for the
 3427  purpose of processing its return or its destruction must obtain
 3428  a permit as a restricted prescription drug distributor if such
 3429  person is not the person initiating the return, the prescription
 3430  drug wholesale supplier of the person initiating the return, or
 3431  the manufacturer of the drug.
 3432         c.A blood establishment located in this state that
 3433  collects blood and blood components only from volunteer donors
 3434  as defined in s. 381.06014 or pursuant to an authorized
 3435  practitioner’s order for medical treatment or therapy and
 3436  engages in the wholesale distribution of a prescription drug not
 3437  described in s. 499.003(53)(d) to a health care entity. The
 3438  health care entity receiving a prescription drug distributed
 3439  under this sub-subparagraph must be licensed as a closed
 3440  pharmacy or provide health care services at that establishment.
 3441  The blood establishment must operate in accordance with s.
 3442  381.06014 and may distribute only:
 3443         (I) Prescription drugs indicated for a bleeding or clotting
 3444  disorder or anemia;
 3445         (II) Blood-collection containers approved under s. 505 of
 3446  the federal act;
 3447         (III) Drugs that are blood derivatives, or a recombinant or
 3448  synthetic form of a blood derivative; or
 3449         (IV) Prescription drugs identified in rules adopted by the
 3450  department which are essential to services performed or provided
 3451  by blood establishments and authorized for distribution by blood
 3452  establishments under federal law,
 3453  
 3454  as long as all of the health care services provided by the blood
 3455  establishment are related to its activities as a registered
 3456  blood establishment or the health care services consist of
 3457  collecting, processing, storing, or administering human
 3458  hematopoietic stem cells or progenitor cells or performing
 3459  diagnostic testing of specimens if such specimens are tested
 3460  together with specimens undergoing routine donor testing.
 3461         2. Storage, handling, and recordkeeping of these
 3462  distributions by a person permitted as a restricted prescription
 3463  drug distributor must comply with the requirements for wholesale
 3464  distributors under s. 499.0121, but not those set forth in s.
 3465  499.01212 if the distribution occurs pursuant to sub
 3466  subparagraph 1.a. or sub-subparagraph 1.b.
 3467         3. A person who applies for a permit as a restricted
 3468  prescription drug distributor, or for the renewal of such a
 3469  permit, must provide to the department the information required
 3470  under s. 499.012.
 3471         4. The department may adopt rules regarding the
 3472  distribution of prescription drugs by hospitals, health care
 3473  entities, charitable organizations, or other persons not
 3474  involved in wholesale distribution, and blood establishments;
 3475  which rules are necessary for the protection of the public
 3476  health, safety, and welfare. The department may adopt rules
 3477  related to the transportation, storage, and recordkeeping of
 3478  prescription drugs which are essential to services performed or
 3479  provided by a blood establishment, including requirements for
 3480  the use of prescription drugs in mobile blood-collection
 3481  vehicles.
 3482         Section 91. Paragraph (i) is added to subsection (3) of
 3483  section 499.01212, Florida Statutes, to read:
 3484         499.01212 Pedigree paper.—
 3485         (3) EXCEPTIONS.—A pedigree paper is not required for:
 3486         (i)The wholesale distribution of prescription drugs
 3487  contained within a sealed medical convenience kit if the kit:
 3488         1.Is assembled in an establishment that is registered as a
 3489  medical device manufacturer with the Food and Drug
 3490  Administration; and
 3491         2.Does not contain any controlled substance that appears
 3492  in any schedule contained in or subject to chapter 893 or the
 3493  federal Comprehensive Drug Abuse Prevention and Control Act of
 3494  1970.
 3495         Section 92. Subsection (1) of section 627.645, Florida
 3496  Statutes, is amended to read:
 3497         627.645 Denial of health insurance claims restricted.—
 3498         (1) No claim for payment under a health insurance policy or
 3499  self-insured program of health benefits for treatment, care, or
 3500  services in a licensed hospital which is accredited by The Joint
 3501  Commission on the Accreditation of Hospitals, the American
 3502  Osteopathic Association, or the Commission on the Accreditation
 3503  of Rehabilitative Facilities shall be denied because such
 3504  hospital lacks major surgical facilities and is primarily of a
 3505  rehabilitative nature, if such rehabilitation is specifically
 3506  for treatment of physical disability.
 3507         Section 93. Paragraph (c) of subsection (2) of section
 3508  627.668, Florida Statutes, is amended to read:
 3509         627.668 Optional coverage for mental and nervous disorders
 3510  required; exception.—
 3511         (2) Under group policies or contracts, inpatient hospital
 3512  benefits, partial hospitalization benefits, and outpatient
 3513  benefits consisting of durational limits, dollar amounts,
 3514  deductibles, and coinsurance factors shall not be less favorable
 3515  than for physical illness generally, except that:
 3516         (c) Partial hospitalization benefits shall be provided
 3517  under the direction of a licensed physician. For purposes of
 3518  this part, the term “partial hospitalization services” is
 3519  defined as those services offered by a program accredited by The
 3520  Joint Commission on Accreditation of Hospitals (JCAH) or in
 3521  compliance with equivalent standards. Alcohol rehabilitation
 3522  programs accredited by The Joint Commission on Accreditation of
 3523  Hospitals or approved by the state and licensed drug abuse
 3524  rehabilitation programs shall also be qualified providers under
 3525  this section. In any benefit year, if partial hospitalization
 3526  services or a combination of inpatient and partial
 3527  hospitalization are utilized, the total benefits paid for all
 3528  such services shall not exceed the cost of 30 days of inpatient
 3529  hospitalization for psychiatric services, including physician
 3530  fees, which prevail in the community in which the partial
 3531  hospitalization services are rendered. If partial
 3532  hospitalization services benefits are provided beyond the limits
 3533  set forth in this paragraph, the durational limits, dollar
 3534  amounts, and coinsurance factors thereof need not be the same as
 3535  those applicable to physical illness generally.
 3536         Section 94. Subsection (3) of section 627.669, Florida
 3537  Statutes, is amended to read:
 3538         627.669 Optional coverage required for substance abuse
 3539  impaired persons; exception.—
 3540         (3) The benefits provided under this section shall be
 3541  applicable only if treatment is provided by, or under the
 3542  supervision of, or is prescribed by, a licensed physician or
 3543  licensed psychologist and if services are provided in a program
 3544  accredited by The Joint Commission on Accreditation of Hospitals
 3545  or approved by the state.
 3546         Section 95. Paragraph (a) of subsection (1) of section
 3547  627.736, Florida Statutes, is amended to read:
 3548         627.736 Required personal injury protection benefits;
 3549  exclusions; priority; claims.—
 3550         (1) REQUIRED BENEFITS.—Every insurance policy complying
 3551  with the security requirements of s. 627.733 shall provide
 3552  personal injury protection to the named insured, relatives
 3553  residing in the same household, persons operating the insured
 3554  motor vehicle, passengers in such motor vehicle, and other
 3555  persons struck by such motor vehicle and suffering bodily injury
 3556  while not an occupant of a self-propelled vehicle, subject to
 3557  the provisions of subsection (2) and paragraph (4)(e), to a
 3558  limit of $10,000 for loss sustained by any such person as a
 3559  result of bodily injury, sickness, disease, or death arising out
 3560  of the ownership, maintenance, or use of a motor vehicle as
 3561  follows:
 3562         (a) Medical benefits.—Eighty percent of all reasonable
 3563  expenses for medically necessary medical, surgical, X-ray,
 3564  dental, and rehabilitative services, including prosthetic
 3565  devices, and medically necessary ambulance, hospital, and
 3566  nursing services. However, the medical benefits shall provide
 3567  reimbursement only for such services and care that are lawfully
 3568  provided, supervised, ordered, or prescribed by a physician
 3569  licensed under chapter 458 or chapter 459, a dentist licensed
 3570  under chapter 466, or a chiropractic physician licensed under
 3571  chapter 460 or that are provided by any of the following persons
 3572  or entities:
 3573         1. A hospital or ambulatory surgical center licensed under
 3574  chapter 395.
 3575         2. A person or entity licensed under ss. 401.2101-401.45
 3576  that provides emergency transportation and treatment.
 3577         3. An entity wholly owned by one or more physicians
 3578  licensed under chapter 458 or chapter 459, chiropractic
 3579  physicians licensed under chapter 460, or dentists licensed
 3580  under chapter 466 or by such practitioner or practitioners and
 3581  the spouse, parent, child, or sibling of that practitioner or
 3582  those practitioners.
 3583         4. An entity wholly owned, directly or indirectly, by a
 3584  hospital or hospitals.
 3585         5. A health care clinic licensed under ss. 400.990-400.995
 3586  that is:
 3587         a. Accredited by The Joint Commission on Accreditation of
 3588  Healthcare Organizations, the American Osteopathic Association,
 3589  the Commission on Accreditation of Rehabilitation Facilities, or
 3590  the Accreditation Association for Ambulatory Health Care, Inc.;
 3591  or
 3592         b. A health care clinic that:
 3593         (I) Has a medical director licensed under chapter 458,
 3594  chapter 459, or chapter 460;
 3595         (II) Has been continuously licensed for more than 3 years
 3596  or is a publicly traded corporation that issues securities
 3597  traded on an exchange registered with the United States
 3598  Securities and Exchange Commission as a national securities
 3599  exchange; and
 3600         (III) Provides at least four of the following medical
 3601  specialties:
 3602         (A) General medicine.
 3603         (B) Radiography.
 3604         (C) Orthopedic medicine.
 3605         (D) Physical medicine.
 3606         (E) Physical therapy.
 3607         (F) Physical rehabilitation.
 3608         (G) Prescribing or dispensing outpatient prescription
 3609  medication.
 3610         (H) Laboratory services.
 3611  
 3612  The Financial Services Commission shall adopt by rule the form
 3613  that must be used by an insurer and a health care provider
 3614  specified in subparagraph 3., subparagraph 4., or subparagraph
 3615  5. to document that the health care provider meets the criteria
 3616  of this paragraph, which rule must include a requirement for a
 3617  sworn statement or affidavit.
 3618  
 3619  Only insurers writing motor vehicle liability insurance in this
 3620  state may provide the required benefits of this section, and no
 3621  such insurer shall require the purchase of any other motor
 3622  vehicle coverage other than the purchase of property damage
 3623  liability coverage as required by s. 627.7275 as a condition for
 3624  providing such required benefits. Insurers may not require that
 3625  property damage liability insurance in an amount greater than
 3626  $10,000 be purchased in conjunction with personal injury
 3627  protection. Such insurers shall make benefits and required
 3628  property damage liability insurance coverage available through
 3629  normal marketing channels. Any insurer writing motor vehicle
 3630  liability insurance in this state who fails to comply with such
 3631  availability requirement as a general business practice shall be
 3632  deemed to have violated part IX of chapter 626, and such
 3633  violation shall constitute an unfair method of competition or an
 3634  unfair or deceptive act or practice involving the business of
 3635  insurance; and any such insurer committing such violation shall
 3636  be subject to the penalties afforded in such part, as well as
 3637  those which may be afforded elsewhere in the insurance code.
 3638         Section 96. Section 633.081, Florida Statutes, is amended
 3639  to read:
 3640         633.081 Inspection of buildings and equipment; orders;
 3641  firesafety inspection training requirements; certification;
 3642  disciplinary action.—The State Fire Marshal and her or his
 3643  agents shall, at any reasonable hour, when the department has
 3644  reasonable cause to believe that a violation of this chapter or
 3645  s. 509.215, or a rule promulgated thereunder, or a minimum
 3646  firesafety code adopted by a local authority, may exist, inspect
 3647  any and all buildings and structures which are subject to the
 3648  requirements of this chapter or s. 509.215 and rules promulgated
 3649  thereunder. The authority to inspect shall extend to all
 3650  equipment, vehicles, and chemicals which are located within the
 3651  premises of any such building or structure. The State Fire
 3652  Marshal and her or his agents shall inspect nursing homes
 3653  licensed under part II of chapter 400 only once every calendar
 3654  year and upon receiving a complaint forming the basis of a
 3655  reasonable cause to believe that a violation of this chapter or
 3656  s. 509.215, or a rule promulgated thereunder, or a minimum
 3657  firesafety code adopted by a local authority may exist and upon
 3658  identifying such a violation in the course of conducting
 3659  orientation or training activities within a nursing home.
 3660         (1) Each county, municipality, and special district that
 3661  has firesafety enforcement responsibilities shall employ or
 3662  contract with a firesafety inspector. The firesafety inspector
 3663  must conduct all firesafety inspections that are required by
 3664  law. The governing body of a county, municipality, or special
 3665  district that has firesafety enforcement responsibilities may
 3666  provide a schedule of fees to pay only the costs of inspections
 3667  conducted pursuant to this subsection and related administrative
 3668  expenses. Two or more counties, municipalities, or special
 3669  districts that have firesafety enforcement responsibilities may
 3670  jointly employ or contract with a firesafety inspector.
 3671         (2) Every firesafety inspection conducted pursuant to state
 3672  or local firesafety requirements shall be by a person certified
 3673  as having met the inspection training requirements set by the
 3674  State Fire Marshal. Such person shall:
 3675         (a) Be a high school graduate or the equivalent as
 3676  determined by the department;
 3677         (b) Not have been found guilty of, or having pleaded guilty
 3678  or nolo contendere to, a felony or a crime punishable by
 3679  imprisonment of 1 year or more under the law of the United
 3680  States, or of any state thereof, which involves moral turpitude,
 3681  without regard to whether a judgment of conviction has been
 3682  entered by the court having jurisdiction of such cases;
 3683         (c) Have her or his fingerprints on file with the
 3684  department or with an agency designated by the department;
 3685         (d) Have good moral character as determined by the
 3686  department;
 3687         (e) Be at least 18 years of age;
 3688         (f) Have satisfactorily completed the firesafety inspector
 3689  certification examination as prescribed by the department; and
 3690         (g)1. Have satisfactorily completed, as determined by the
 3691  department, a firesafety inspector training program of not less
 3692  than 200 hours established by the department and administered by
 3693  agencies and institutions approved by the department for the
 3694  purpose of providing basic certification training for firesafety
 3695  inspectors; or
 3696         2. Have received in another state training which is
 3697  determined by the department to be at least equivalent to that
 3698  required by the department for approved firesafety inspector
 3699  education and training programs in this state.
 3700         (3) Each special state firesafety inspection which is
 3701  required by law and is conducted by or on behalf of an agency of
 3702  the state must be performed by an individual who has met the
 3703  provision of subsection (2), except that the duration of the
 3704  training program shall not exceed 120 hours of specific training
 3705  for the type of property that such special state firesafety
 3706  inspectors are assigned to inspect.
 3707         (4) A firefighter certified pursuant to s. 633.35 may
 3708  conduct firesafety inspections, under the supervision of a
 3709  certified firesafety inspector, while on duty as a member of a
 3710  fire department company conducting inservice firesafety
 3711  inspections without being certified as a firesafety inspector,
 3712  if such firefighter has satisfactorily completed an inservice
 3713  fire department company inspector training program of at least
 3714  24 hours’ duration as provided by rule of the department.
 3715         (5) Every firesafety inspector or special state firesafety
 3716  inspector certificate is valid for a period of 3 years from the
 3717  date of issuance. Renewal of certification shall be subject to
 3718  the affected person’s completing proper application for renewal
 3719  and meeting all of the requirements for renewal as established
 3720  under this chapter or by rule promulgated thereunder, which
 3721  shall include completion of at least 40 hours during the
 3722  preceding 3-year period of continuing education as required by
 3723  the rule of the department or, in lieu thereof, successful
 3724  passage of an examination as established by the department.
 3725         (6) The State Fire Marshal may deny, refuse to renew,
 3726  suspend, or revoke the certificate of a firesafety inspector or
 3727  special state firesafety inspector if it finds that any of the
 3728  following grounds exist:
 3729         (a) Any cause for which issuance of a certificate could
 3730  have been refused had it then existed and been known to the
 3731  State Fire Marshal.
 3732         (b) Violation of this chapter or any rule or order of the
 3733  State Fire Marshal.
 3734         (c) Falsification of records relating to the certificate.
 3735         (d) Having been found guilty of or having pleaded guilty or
 3736  nolo contendere to a felony, whether or not a judgment of
 3737  conviction has been entered.
 3738         (e) Failure to meet any of the renewal requirements.
 3739         (f) Having been convicted of a crime in any jurisdiction
 3740  which directly relates to the practice of fire code inspection,
 3741  plan review, or administration.
 3742         (g) Making or filing a report or record that the
 3743  certificateholder knows to be false, or knowingly inducing
 3744  another to file a false report or record, or knowingly failing
 3745  to file a report or record required by state or local law, or
 3746  knowingly impeding or obstructing such filing, or knowingly
 3747  inducing another person to impede or obstruct such filing.
 3748         (h) Failing to properly enforce applicable fire codes or
 3749  permit requirements within this state which the
 3750  certificateholder knows are applicable by committing willful
 3751  misconduct, gross negligence, gross misconduct, repeated
 3752  negligence, or negligence resulting in a significant danger to
 3753  life or property.
 3754         (i) Accepting labor, services, or materials at no charge or
 3755  at a noncompetitive rate from any person who performs work that
 3756  is under the enforcement authority of the certificateholder and
 3757  who is not an immediate family member of the certificateholder.
 3758  For the purpose of this paragraph, the term “immediate family
 3759  member” means a spouse, child, parent, sibling, grandparent,
 3760  aunt, uncle, or first cousin of the person or the person’s
 3761  spouse or any person who resides in the primary residence of the
 3762  certificateholder.
 3763         (7) The department shall provide by rule for the
 3764  certification of firesafety inspectors.
 3765         Section 97. Subsection (12) of section 641.495, Florida
 3766  Statutes, is amended to read:
 3767         641.495 Requirements for issuance and maintenance of
 3768  certificate.—
 3769         (12) The provisions of part I of chapter 395 do not apply
 3770  to a health maintenance organization that, on or before January
 3771  1, 1991, provides not more than 10 outpatient holding beds for
 3772  short-term and hospice-type patients in an ambulatory care
 3773  facility for its members, provided that such health maintenance
 3774  organization maintains current accreditation by The Joint
 3775  Commission on Accreditation of Health Care Organizations, the
 3776  Accreditation Association for Ambulatory Health Care, or the
 3777  National Committee for Quality Assurance.
 3778         Section 98. Subsection (13) of section 651.118, Florida
 3779  Statutes, is amended to read:
 3780         651.118 Agency for Health Care Administration; certificates
 3781  of need; sheltered beds; community beds.—
 3782         (13) Residents, as defined in this chapter, are not
 3783  considered new admissions for the purpose of s.
 3784  400.141(1)(n)(o)1.d.
 3785         Section 99. Subsection (2) of section 766.1015, Florida
 3786  Statutes, is amended to read:
 3787         766.1015 Civil immunity for members of or consultants to
 3788  certain boards, committees, or other entities.—
 3789         (2) Such committee, board, group, commission, or other
 3790  entity must be established in accordance with state law or in
 3791  accordance with requirements of The Joint Commission on
 3792  Accreditation of Healthcare Organizations, established and duly
 3793  constituted by one or more public or licensed private hospitals
 3794  or behavioral health agencies, or established by a governmental
 3795  agency. To be protected by this section, the act, decision,
 3796  omission, or utterance may not be made or done in bad faith or
 3797  with malicious intent.
 3798         Section 100. Subsection (4) of section 766.202, Florida
 3799  Statutes, is amended to read:
 3800         766.202 Definitions; ss. 766.201-766.212.—As used in ss.
 3801  766.201-766.212, the term:
 3802         (4) “Health care provider” means any hospital, ambulatory
 3803  surgical center, or mobile surgical facility as defined and
 3804  licensed under chapter 395; a birth center licensed under
 3805  chapter 383; any person licensed under chapter 458, chapter 459,
 3806  chapter 460, chapter 461, chapter 462, chapter 463, part I of
 3807  chapter 464, chapter 466, chapter 467, part XIV of chapter 468,
 3808  or chapter 486; a clinical lab licensed under chapter 483; a
 3809  health maintenance organization certificated under part I of
 3810  chapter 641; a blood bank; a plasma center; an industrial
 3811  clinic; a renal dialysis facility; or a professional association
 3812  partnership, corporation, joint venture, or other association
 3813  for professional activity by health care providers.
 3814         Section 101. This act shall take effect July 1, 2010.

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