Florida Senate - 2012                      CS for CS for SB 1316
       
       
       
       By the Committees on Budget Subcommittee on Health and Human
       Services Appropriations; and Health Regulation; and Senator
       Gaetz
       
       
       603-04243-12                                          20121316c2
    1                        A bill to be entitled                      
    2         An act relating to health care; amending s. 395.002,
    3         F.S.; redefining the term “accrediting organizations”
    4         as it applies to the regulation of hospitals and other
    5         licensed facilities; amending s. 400.474, F.S.;
    6         revising the fine that may be imposed against a home
    7         health agency for failing to timely submit certain
    8         information to the Agency for Health Care
    9         Administration; amending s. 400.9905, F.S.; revising
   10         the definition of the term “clinic” as it relates to
   11         the Health Care Clinic Act; amending s. 409.221, F.S.;
   12         revising the background screening requirements for
   13         persons rendering care in the consumer-directed care
   14         program administered by the Agency for Health Care
   15         Administration; amending s. 409.907, F.S.; extending
   16         the records-retention period for certain Medicaid
   17         provider records; revising the provider agreement to
   18         require Medicaid providers to report changes in any
   19         principal of the provider to the agency; defining the
   20         term “administrative fines” for purposes of revoking a
   21         Medicaid provider agreement due to changes of
   22         ownership; authorizing, rather than requiring, an
   23         onsite inspection of a Medicaid provider’s service
   24         location before entering into a provider agreement;
   25         specifying the principals of a hospital or nursing
   26         home provider for the purposes of submitting
   27         fingerprints for background screening; removing
   28         certain providers from being subject to agency
   29         background checks; amending s. 409.913, F.S.; defining
   30         the term “Medicaid provider” or “provider” for
   31         purposes of oversight of the integrity of the Medicaid
   32         program; authorizing the agency to review and analyze
   33         information from sources other than Medicaid-enrolled
   34         providers for purposes of determining fraud, abuse,
   35         overpayment, or neglect; extending the records
   36         retention period for certain Medicaid provider
   37         records; revising the grounds for terminating a
   38         provider from the Medicaid program; requiring the
   39         agency to base its overpayment audit reports on
   40         certain information; deleting a requirement that the
   41         agency pay interest on certain withheld Medicaid
   42         payments; requiring payment arrangements for
   43         overpayments and fines to be made within a certain
   44         time; specifying that the venue for all Medicaid
   45         program integrity cases lies in Leon County;
   46         authorizing the agency and the Medicaid Fraud Control
   47         Unit to review certain records; amending s. 409.920,
   48         F.S.; clarifying the applicability of immunity from
   49         civil liability extended to persons who provide
   50         information about fraud or suspected fraudulent acts
   51         by a Medicaid provider; amending s. 409.967, F.S.;
   52         specifying required components of a Medicaid managed
   53         care plan relating to the provisions of medications;
   54         amending s. 429.23, F.S.; requiring the agency to
   55         submit a report to the Legislature on adverse incident
   56         reports from assisted living facilities; amending s.
   57         429.26, F.S.; authorizing the agency to require a
   58         resident of an assisted living facility to undergo a
   59         physical examination if the agency questions the
   60         appropriateness of the resident’s placement in that
   61         facility; authorizing release of the results of the
   62         examination to a medical review team to be used along
   63         with additional information to determine whether the
   64         resident’s placement in the assisted living facility
   65         is appropriate; providing for resident notification
   66         and relocation if the resident’s continued placement
   67         in the facility is not appropriate; authorizing the
   68         agency to require the evaluation of a mental health
   69         resident by a mental health professional; authorizing
   70         an assisted living facility to discharge a resident
   71         who requires more services or care than the facility
   72         is able to provide; amending s. 456.0635, F.S.;
   73         revising the grounds under which the Department of
   74         Health or corresponding board is required to refuse to
   75         admit a candidate to an examination and refuse to
   76         issue or renew a license, certificate, or registration
   77         of a health care practitioner; providing an exception;
   78         amending s. 456.036, F.S.; providing that all persons
   79         who were denied renewal of licensure, certification,
   80         or registration under s. 456.0635(3), F.S., may regain
   81         licensure, certification, or registration only by
   82         completing the application process for initial
   83         licensure; providing an exception; amending s.
   84         456.074, F.S.; revising the federal offenses for which
   85         the Department of Health must issue an emergency order
   86         suspending the license of certain health care
   87         professionals; amending ss. 458.309 and 459.005, F.S.;
   88         requiring a physician or osteopathic physician who
   89         performs certain medical procedures relating to
   90         liposuction in an office setting to register the
   91         office with the Department of Health unless that
   92         office is licensed as a facility under ch. 395, F.S.,
   93         relating to hospital licensing and regulation;
   94         amending s. 463.002, F.S.; conforming provisions to
   95         changes made by the act; amending s. 463.005, F.S.;
   96         authorizing the Board of Optometry to adopt rules for
   97         the administration and prescription of ocular
   98         pharmaceutical agents; amending s. 463.0055, F.S.;
   99         authorizing certified optometrists to administer and
  100         prescribe pharmaceutical agents under certain
  101         circumstances; requiring that a certified optometrist
  102         complete a course and subsequent examination on
  103         general and ocular pharmacology; providing
  104         requirements for the course; requiring that the
  105         Florida Medical Association and the Florida Optometric
  106         Association jointly develop and administer the course
  107         and examination; revising qualifications of certain
  108         members of the formulary committee; providing for a
  109         formulary of topical ocular pharmaceutical agents
  110         which the committee may modify; specifying the agents
  111         that make up the statutory formulary of oral
  112         pharmaceutical agents; authorizing the deletion of an
  113         oral pharmaceutical agent listed in the statutory
  114         formulary under certain circumstances; prohibiting the
  115         board, the Department of Health, or the State Surgeon
  116         General from deleting an oral pharmaceutical agent
  117         listed in the statutory formulary; amending ss.
  118         463.0057 and 463.006, F.S.; conforming provisions to
  119         changes made by the act; amending s. 463.0135, F.S.;
  120         requiring that a certified optometrist administer and
  121         prescribe oral ocular pharmaceutical agents in a
  122         certain manner; requiring that a licensed practitioner
  123         who diagnoses a patient who has a neovascular form of
  124         glaucoma or progressive glaucoma immediately refer the
  125         patient to a physician who is skilled in the diseases
  126         of the eye; requiring that comanagement of
  127         postoperative care be conducted pursuant to an
  128         established protocol; requiring that the patient be
  129         informed that a physician will be available for
  130         emergency care throughout the postoperative period;
  131         requiring that the patient consent in writing to the
  132         comanagement relationship; amending s. 463.014, F.S.;
  133         revising certain prohibited acts regarding an
  134         optometrist conducting surgery and dispensing,
  135         administering, ordering, supplying, or selling certain
  136         drugs; creating s. 463.0141, F.S.; requiring that
  137         adverse incidents in the practice of optometry be
  138         reported to the Department of Health; providing
  139         requirements for notifying the department of an
  140         adverse incident; providing a definition; requiring
  141         that the department review each incident and determine
  142         whether it involved conduct that is subject to
  143         disciplinary action; requiring that the Board of
  144         Optometry take disciplinary action if necessary;
  145         amending s. 483.035, F.S., relating to licensure and
  146         regulation of clinical laboratories operated by
  147         practitioners for exclusive use; providing
  148         applicability to clinical laboratories operated by
  149         practitioners licensed to practice optometry; amending
  150         s. 483.041, F.S.; revising the definition of the term
  151         “licensed practitioner” to include a practitioner
  152         licensed under ch. 463, F.S.; amending s. 483.181,
  153         F.S.; requiring clinical laboratories to accept human
  154         specimens submitted by practitioners licensed to
  155         practice under ch. 463, F.S.; amending s. 499.003,
  156         F.S.; removing a requirement that a contract provider
  157         or subcontractor maintain prescription drugs of the
  158         agency or entity in its possession separate and apart
  159         from other prescription drugs; amending s. 766.102,
  160         F.S.; providing that the claimant has the burden of
  161         proving by clear and convincing evidence that the
  162         actions of a health care provider represented a breach
  163         of the prevailing professional standard of care in an
  164         action for damages based on death or personal injury
  165         which alleges that the death or injury resulted from
  166         the failure of a health care provider to order,
  167         perform, or administer supplemental diagnostic tests;
  168         amending s. 766.106, F.S.; authorizing a prospective
  169         defendant to obtain informal discovery by conducting
  170         ex parte interviews of treating health care providers;
  171         requiring advance notice to the claimant of an ex
  172         parte interview; amending s. 893.02, F.S.; revising
  173         the definition of the term “practitioner” to include
  174         certified optometrists for purposes of the Florida
  175         Comprehensive Drug Abuse Prevention and Control Act;
  176         amending s. 893.05, F.S.; prohibiting certified
  177         optometrists from administering and prescribing
  178         certain controlled substances; requiring the Agency
  179         for Health Care Administration to prepare a report for
  180         public comment and submission to the Legislature
  181         following the expansion of services to new populations
  182         or of new services; providing for severability;
  183         providing effective dates.
  184  
  185  Be It Enacted by the Legislature of the State of Florida:
  186  
  187         Section 1. Subsection (1) of section 395.002, Florida
  188  Statutes, is amended to read:
  189         395.002 Definitions.—As used in this chapter:
  190         (1) “Accrediting organizations” means national
  191  accreditation organizations that are approved by the Centers for
  192  Medicare and Medicaid Services and whose standards incorporate
  193  comparable licensure regulations required by the state the Joint
  194  Commission on Accreditation of Healthcare Organizations, the
  195  American Osteopathic Association, the Commission on
  196  Accreditation of Rehabilitation Facilities, and the
  197  Accreditation Association for Ambulatory Health Care, Inc.
  198         Section 2. Subsection (6) of section 400.474, Florida
  199  Statutes, is amended, present subsection (7) of that section is
  200  renumbered as subsection (8), and a new subsection (7) is added
  201  to that section, to read:
  202         400.474 Administrative penalties.—
  203         (6) The agency may deny, revoke, or suspend the license of
  204  a home health agency and shall impose a fine of $5,000 against a
  205  home health agency that:
  206         (a) Gives remuneration for staffing services to:
  207         1. Another home health agency with which it has formal or
  208  informal patient-referral transactions or arrangements; or
  209         2. A health services pool with which it has formal or
  210  informal patient-referral transactions or arrangements,
  211  
  212  unless the home health agency has activated its comprehensive
  213  emergency management plan in accordance with s. 400.492. This
  214  paragraph does not apply to a Medicare-certified home health
  215  agency that provides fair market value remuneration for staffing
  216  services to a non-Medicare-certified home health agency that is
  217  part of a continuing care facility licensed under chapter 651
  218  for providing services to its own residents if each resident
  219  receiving home health services pursuant to this arrangement
  220  attests in writing that he or she made a decision without
  221  influence from staff of the facility to select, from a list of
  222  Medicare-certified home health agencies provided by the
  223  facility, that Medicare-certified home health agency to provide
  224  the services.
  225         (b) Provides services to residents in an assisted living
  226  facility for which the home health agency does not receive fair
  227  market value remuneration.
  228         (c) Provides staffing to an assisted living facility for
  229  which the home health agency does not receive fair market value
  230  remuneration.
  231         (d) Fails to provide the agency, upon request, with copies
  232  of all contracts with assisted living facilities which were
  233  executed within 5 years before the request.
  234         (e) Gives remuneration to a case manager, discharge
  235  planner, facility-based staff member, or third-party vendor who
  236  is involved in the discharge planning process of a facility
  237  licensed under chapter 395, chapter 429, or this chapter from
  238  whom the home health agency receives referrals.
  239         (f) Fails to submit to the agency, within 15 days after the
  240  end of each calendar quarter, a written report that includes the
  241  following data based on data as it existed on the last day of
  242  the quarter:
  243         1. The number of insulin-dependent diabetic patients
  244  receiving insulin-injection services from the home health
  245  agency;
  246         2. The number of patients receiving both home health
  247  services from the home health agency and hospice services;
  248         3. The number of patients receiving home health services
  249  from that home health agency; and
  250         4. The names and license numbers of nurses whose primary
  251  job responsibility is to provide home health services to
  252  patients and who received remuneration from the home health
  253  agency in excess of $25,000 during the calendar quarter.
  254         (f)(g) Gives cash, or its equivalent, to a Medicare or
  255  Medicaid beneficiary.
  256         (g)(h) Has more than one medical director contract in
  257  effect at one time or more than one medical director contract
  258  and one contract with a physician-specialist whose services are
  259  mandated for the home health agency in order to qualify to
  260  participate in a federal or state health care program at one
  261  time.
  262         (h)(i) Gives remuneration to a physician without a medical
  263  director contract being in effect. The contract must:
  264         1. Be in writing and signed by both parties;
  265         2. Provide for remuneration that is at fair market value
  266  for an hourly rate, which must be supported by invoices
  267  submitted by the medical director describing the work performed,
  268  the dates on which that work was performed, and the duration of
  269  that work; and
  270         3. Be for a term of at least 1 year.
  271  
  272  The hourly rate specified in the contract may not be increased
  273  during the term of the contract. The home health agency may not
  274  execute a subsequent contract with that physician which has an
  275  increased hourly rate and covers any portion of the term that
  276  was in the original contract.
  277         (i)(j) Gives remuneration to:
  278         1. A physician, and the home health agency is in violation
  279  of paragraph (g) (h) or paragraph (h) (i);
  280         2. A member of the physician’s office staff; or
  281         3. An immediate family member of the physician,
  282  
  283  if the home health agency has received a patient referral in the
  284  preceding 12 months from that physician or physician’s office
  285  staff.
  286         (j)(k) Fails to provide to the agency, upon request, copies
  287  of all contracts with a medical director which were executed
  288  within 5 years before the request.
  289         (k)(l) Demonstrates a pattern of billing the Medicaid
  290  program for services to Medicaid recipients which are medically
  291  unnecessary as determined by a final order. A pattern may be
  292  demonstrated by a showing of at least two such medically
  293  unnecessary services within one Medicaid program integrity audit
  294  period.
  295  
  296  Paragraphs (e) and (i) do not apply to or preclude Nothing in
  297  paragraph (e) or paragraph (j) shall be interpreted as applying
  298  to or precluding any discount, compensation, waiver of payment,
  299  or payment practice permitted by 42 U.S.C. s. 1320a-7(b) or
  300  regulations adopted thereunder, including 42 C.F.R. s. 1001.952
  301  or s. 1395nn or regulations adopted thereunder.
  302         (7) The agency shall impose a fine of $50 per day against a
  303  home health agency that fails to submit to the agency, within 15
  304  days after the end of each calendar quarter, a written report
  305  that includes the following data based on data as it existed on
  306  the last day of the quarter:
  307         (a) The number of patients receiving both home health
  308  services from the home health agency and hospice services;
  309         (b) The number of patients receiving home health services
  310  from the home health agency;
  311         (c) The number of insulin-dependent diabetic patients
  312  receiving insulin-injection services from the home health
  313  agency; and
  314         (d) The names and license numbers of nurses whose primary
  315  job responsibility is to provide home health services to
  316  patients and who received remuneration from the home health
  317  agency in excess of $25,000 during the calendar quarter.
  318         Section 3. Paragraph (l) of subsection (4) of section
  319  400.9905, Florida Statutes, is amended, and paragraph (m) is
  320  added to that subsection, to read:
  321         400.9905 Definitions.—
  322         (4) “Clinic” means an entity at which health care services
  323  are provided to individuals and which tenders charges for
  324  reimbursement for such services, including a mobile clinic and a
  325  portable equipment provider. For purposes of this part, the term
  326  does not include and the licensure requirements of this part do
  327  not apply to:
  328         (l) Orthotic, or prosthetic, pediatric cardiology, or
  329  perinatology clinical facilities or anesthesia clinical
  330  facilities that are not otherwise exempt under paragraph (a) or
  331  paragraph (k) and that are a publicly traded corporation or that
  332  are wholly owned, directly or indirectly, by a publicly traded
  333  corporation. As used in this paragraph, a publicly traded
  334  corporation is a corporation that issues securities traded on an
  335  exchange registered with the United States Securities and
  336  Exchange Commission as a national securities exchange.
  337         (m)Entities that are owned or controlled, directly or
  338  indirectly, by a publicly traded entity that has $100 million or
  339  more, in the aggregate, in total annual revenues derived from
  340  providing health care services by licensed health care
  341  practitioners who are employed or contracted by an entity
  342  described in this paragraph.
  343         Section 4. Paragraph (i) of subsection (4) of section
  344  409.221, Florida Statutes, is amended to read:
  345         409.221 Consumer-directed care program.—
  346         (4) CONSUMER-DIRECTED CARE.—
  347         (i) Background screening requirements.—All persons who
  348  render care under this section must undergo level 2 background
  349  screening pursuant to chapter 435 and s. 408.809. The agency
  350  shall, as allowable, reimburse consumer-employed caregivers for
  351  the cost of conducting such background screening as required by
  352  this section. For purposes of this section, a person who has
  353  undergone screening, who is qualified for employment under this
  354  section and applicable rule, and who has not been unemployed for
  355  more than 90 days following such screening is not required to be
  356  rescreened. Such person must attest under penalty of perjury to
  357  not having been convicted of a disqualifying offense since
  358  completing such screening.
  359         Section 5. Paragraph (c) of subsection (3) of section
  360  409.907, Florida Statutes, is amended, paragraph (k) is added to
  361  that subsection, and subsections (6), (7), and (8) of that
  362  section are amended, to read:
  363         409.907 Medicaid provider agreements.—The agency may make
  364  payments for medical assistance and related services rendered to
  365  Medicaid recipients only to an individual or entity who has a
  366  provider agreement in effect with the agency, who is performing
  367  services or supplying goods in accordance with federal, state,
  368  and local law, and who agrees that no person shall, on the
  369  grounds of handicap, race, color, or national origin, or for any
  370  other reason, be subjected to discrimination under any program
  371  or activity for which the provider receives payment from the
  372  agency.
  373         (3) The provider agreement developed by the agency, in
  374  addition to the requirements specified in subsections (1) and
  375  (2), shall require the provider to:
  376         (c) Retain all medical and Medicaid-related records for 6 a
  377  period of 5 years to satisfy all necessary inquiries by the
  378  agency.
  379         (k) Report a change in any principal of the provider,
  380  including any officer, director, agent, managing employee, or
  381  affiliated person, or any partner or shareholder who has an
  382  ownership interest equal to 5 percent or more in the provider,
  383  to the agency in writing no later than 30 days after the change
  384  occurs. For a hospital licensed under chapter 395 or a nursing
  385  home licensed under part II of chapter 400, a principal of the
  386  provider is one who meets the definition of a controlling
  387  interest under s. 408.803.
  388         (6) A Medicaid provider agreement may be revoked, at the
  389  option of the agency, due to as the result of a change of
  390  ownership of any facility, association, partnership, or other
  391  entity named as the provider in the provider agreement.
  392         (a) In the event of a change of ownership, the transferor
  393  remains liable for all outstanding overpayments, administrative
  394  fines, and any other moneys owed to the agency before the
  395  effective date of the change of ownership. In addition to the
  396  continuing liability of the transferor, The transferee is also
  397  liable to the agency for all outstanding overpayments identified
  398  by the agency on or before the effective date of the change of
  399  ownership. For purposes of this subsection, the term
  400  “outstanding overpayment” includes any amount identified in a
  401  preliminary audit report issued to the transferor by the agency
  402  on or before the effective date of the change of ownership. In
  403  the event of a change of ownership for a skilled nursing
  404  facility or intermediate care facility, the Medicaid provider
  405  agreement shall be assigned to the transferee if the transferee
  406  meets all other Medicaid provider qualifications. In the event
  407  of a change of ownership involving a skilled nursing facility
  408  licensed under part II of chapter 400, liability for all
  409  outstanding overpayments, administrative fines, and any moneys
  410  owed to the agency before the effective date of the change of
  411  ownership shall be determined in accordance with s. 400.179.
  412         (b) At least 60 days before the anticipated date of the
  413  change of ownership, the transferor must shall notify the agency
  414  of the intended change of ownership and the transferee must
  415  shall submit to the agency a Medicaid provider enrollment
  416  application. If a change of ownership occurs without compliance
  417  with the notice requirements of this subsection, the transferor
  418  and transferee are shall be jointly and severally liable for all
  419  overpayments, administrative fines, and other moneys due to the
  420  agency, regardless of whether the agency identified the
  421  overpayments, administrative fines, or other moneys before or
  422  after the effective date of the change of ownership. The agency
  423  may not approve a transferee’s Medicaid provider enrollment
  424  application if the transferee or transferor has not paid or
  425  agreed in writing to a payment plan for all outstanding
  426  overpayments, administrative fines, and other moneys due to the
  427  agency. This subsection does not preclude the agency from
  428  seeking any other legal or equitable remedies available to the
  429  agency for the recovery of moneys owed to the Medicaid program.
  430  In the event of a change of ownership involving a skilled
  431  nursing facility licensed under part II of chapter 400,
  432  liability for all outstanding overpayments, administrative
  433  fines, and any moneys owed to the agency before the effective
  434  date of the change of ownership shall be determined in
  435  accordance with s. 400.179 if the Medicaid provider enrollment
  436  application for change of ownership is submitted before the
  437  change of ownership.
  438         (c) As used in this subsection, the term:
  439         1. “Administrative fines” includes any amount identified in
  440  a notice of a monetary penalty or fine which has been issued by
  441  the agency or other regulatory or licensing agency that governs
  442  the provider.
  443         2. “Outstanding overpayment” includes any amount identified
  444  in a preliminary audit report issued to the transferor by the
  445  agency on or before the effective date of a change of ownership.
  446         (7) The agency may require, As a condition of participating
  447  in the Medicaid program and before entering into the provider
  448  agreement, the agency may require that the provider to submit
  449  information, in an initial and any required renewal
  450  applications, concerning the professional, business, and
  451  personal background of the provider and permit an onsite
  452  inspection of the provider’s service location by agency staff or
  453  other personnel designated by the agency to perform this
  454  function. Before entering into a provider agreement, the agency
  455  may shall perform an a random onsite inspection, within 60 days
  456  after receipt of a fully complete new provider’s application, of
  457  the provider’s service location prior to making its first
  458  payment to the provider for Medicaid services to determine the
  459  applicant’s ability to provide the services in compliance with
  460  the Medicaid program and professional regulations that the
  461  applicant is proposing to provide for Medicaid reimbursement.
  462  The agency is not required to perform an onsite inspection of a
  463  provider or program that is licensed by the agency, that
  464  provides services under waiver programs for home and community
  465  based services, or that is licensed as a medical foster home by
  466  the Department of Children and Family Services. As a continuing
  467  condition of participation in the Medicaid program, a provider
  468  must shall immediately notify the agency of any current or
  469  pending bankruptcy filing. Before entering into the provider
  470  agreement, or as a condition of continuing participation in the
  471  Medicaid program, the agency may also require that Medicaid
  472  providers reimbursed on a fee-for-services basis or fee schedule
  473  basis that which is not cost-based, post a surety bond not to
  474  exceed $50,000 or the total amount billed by the provider to the
  475  program during the current or most recent calendar year,
  476  whichever is greater. For new providers, the amount of the
  477  surety bond shall be determined by the agency based on the
  478  provider’s estimate of its first year’s billing. If the
  479  provider’s billing during the first year exceeds the bond
  480  amount, the agency may require the provider to acquire an
  481  additional bond equal to the actual billing level of the
  482  provider. A provider’s bond need shall not exceed $50,000 if a
  483  physician or group of physicians licensed under chapter 458,
  484  chapter 459, or chapter 460 has a 50 percent or greater
  485  ownership interest in the provider or if the provider is an
  486  assisted living facility licensed under chapter 429. The bonds
  487  permitted by this section are in addition to the bonds
  488  referenced in s. 400.179(2)(d). If the provider is a
  489  corporation, partnership, association, or other entity, the
  490  agency may require the provider to submit information concerning
  491  the background of that entity and of any principal of the
  492  entity, including any partner or shareholder having an ownership
  493  interest in the entity equal to 5 percent or greater, and any
  494  treating provider who participates in or intends to participate
  495  in Medicaid through the entity. The information must include:
  496         (a) Proof of holding a valid license or operating
  497  certificate, as applicable, if required by the state or local
  498  jurisdiction in which the provider is located or if required by
  499  the Federal Government.
  500         (b) Information concerning any prior violation, fine,
  501  suspension, termination, or other administrative action taken
  502  under the Medicaid laws, rules, or regulations of this state or
  503  of any other state or the Federal Government; any prior
  504  violation of the laws, rules, or regulations relating to the
  505  Medicare program; any prior violation of the rules or
  506  regulations of any other public or private insurer; and any
  507  prior violation of the laws, rules, or regulations of any
  508  regulatory body of this or any other state.
  509         (c) Full and accurate disclosure of any financial or
  510  ownership interest that the provider, or any principal, partner,
  511  or major shareholder thereof, may hold in any other Medicaid
  512  provider or health care related entity or any other entity that
  513  is licensed by the state to provide health or residential care
  514  and treatment to persons.
  515         (d) If a group provider, identification of all members of
  516  the group and attestation that all members of the group are
  517  enrolled in or have applied to enroll in the Medicaid program.
  518         (8)(a) Each provider, or each principal of the provider if
  519  the provider is a corporation, partnership, association, or
  520  other entity, seeking to participate in the Medicaid program
  521  must submit a complete set of his or her fingerprints to the
  522  agency for the purpose of conducting a criminal history record
  523  check. Principals of the provider include any officer, director,
  524  billing agent, managing employee, or affiliated person, or any
  525  partner or shareholder who has an ownership interest equal to 5
  526  percent or more in the provider. However, for a hospital
  527  licensed under chapter 395 or a nursing home licensed under
  528  chapter 400, principals of the provider are those who meet the
  529  definition of a controlling interest under s. 408.803. A
  530  director of a not-for-profit corporation or organization is not
  531  a principal for purposes of a background investigation as
  532  required by this section if the director: serves solely in a
  533  voluntary capacity for the corporation or organization, does not
  534  regularly take part in the day-to-day operational decisions of
  535  the corporation or organization, receives no remuneration from
  536  the not-for-profit corporation or organization for his or her
  537  service on the board of directors, has no financial interest in
  538  the not-for-profit corporation or organization, and has no
  539  family members with a financial interest in the not-for-profit
  540  corporation or organization; and if the director submits an
  541  affidavit, under penalty of perjury, to this effect to the
  542  agency and the not-for-profit corporation or organization
  543  submits an affidavit, under penalty of perjury, to this effect
  544  to the agency as part of the corporation’s or organization’s
  545  Medicaid provider agreement application.
  546         (a) Notwithstanding the above, the agency may require a
  547  background check for any person reasonably suspected by the
  548  agency to have been convicted of a crime. This subsection does
  549  not apply to:
  550         1. A hospital licensed under chapter 395;
  551         2. A nursing home licensed under chapter 400;
  552         3. A hospice licensed under chapter 400;
  553         4. An assisted living facility licensed under chapter 429;
  554         1.5. A unit of local government, except that requirements
  555  of this subsection apply to nongovernmental providers and
  556  entities contracting with the local government to provide
  557  Medicaid services. The actual cost of the state and national
  558  criminal history record checks must be borne by the
  559  nongovernmental provider or entity; or
  560         2.6. Any business that derives more than 50 percent of its
  561  revenue from the sale of goods to the final consumer, and the
  562  business or its controlling parent is required to file a form
  563  10-K or other similar statement with the Securities and Exchange
  564  Commission or has a net worth of $50 million or more.
  565         (b) Background screening shall be conducted in accordance
  566  with chapter 435 and s. 408.809. The cost of the state and
  567  national criminal record check shall be borne by the provider.
  568         (c) Proof of compliance with the requirements of level 2
  569  screening under chapter 435 conducted within 12 months before
  570  the date the Medicaid provider application is submitted to the
  571  agency fulfills the requirements of this subsection.
  572         Section 6. Present paragraphs (e) and (f) of subsection (1)
  573  of section 409.913, Florida Statutes, are redesignated as
  574  paragraphs (f) and (g), respectively, a new paragraph (e) is
  575  added to that subsection, and subsections (2), (9), (13), (15),
  576  (16), (21), (22), (25), (28), (29), (30), and (31) of that
  577  section are amended, to read:
  578         409.913 Oversight of the integrity of the Medicaid
  579  program.—The agency shall operate a program to oversee the
  580  activities of Florida Medicaid recipients, and providers and
  581  their representatives, to ensure that fraudulent and abusive
  582  behavior and neglect of recipients occur to the minimum extent
  583  possible, and to recover overpayments and impose sanctions as
  584  appropriate. Beginning January 1, 2003, and each year
  585  thereafter, the agency and the Medicaid Fraud Control Unit of
  586  the Department of Legal Affairs shall submit a joint report to
  587  the Legislature documenting the effectiveness of the state’s
  588  efforts to control Medicaid fraud and abuse and to recover
  589  Medicaid overpayments during the previous fiscal year. The
  590  report must describe the number of cases opened and investigated
  591  each year; the sources of the cases opened; the disposition of
  592  the cases closed each year; the amount of overpayments alleged
  593  in preliminary and final audit letters; the number and amount of
  594  fines or penalties imposed; any reductions in overpayment
  595  amounts negotiated in settlement agreements or by other means;
  596  the amount of final agency determinations of overpayments; the
  597  amount deducted from federal claiming as a result of
  598  overpayments; the amount of overpayments recovered each year;
  599  the amount of cost of investigation recovered each year; the
  600  average length of time to collect from the time the case was
  601  opened until the overpayment is paid in full; the amount
  602  determined as uncollectible and the portion of the uncollectible
  603  amount subsequently reclaimed from the Federal Government; the
  604  number of providers, by type, that are terminated from
  605  participation in the Medicaid program as a result of fraud and
  606  abuse; and all costs associated with discovering and prosecuting
  607  cases of Medicaid overpayments and making recoveries in such
  608  cases. The report must also document actions taken to prevent
  609  overpayments and the number of providers prevented from
  610  enrolling in or reenrolling in the Medicaid program as a result
  611  of documented Medicaid fraud and abuse and must include policy
  612  recommendations necessary to prevent or recover overpayments and
  613  changes necessary to prevent and detect Medicaid fraud. All
  614  policy recommendations in the report must include a detailed
  615  fiscal analysis, including, but not limited to, implementation
  616  costs, estimated savings to the Medicaid program, and the return
  617  on investment. The agency must submit the policy recommendations
  618  and fiscal analyses in the report to the appropriate estimating
  619  conference, pursuant to s. 216.137, by February 15 of each year.
  620  The agency and the Medicaid Fraud Control Unit of the Department
  621  of Legal Affairs each must include detailed unit-specific
  622  performance standards, benchmarks, and metrics in the report,
  623  including projected cost savings to the state Medicaid program
  624  during the following fiscal year.
  625         (1) For the purposes of this section, the term:
  626         (e) “Medicaid provider” or “provider” has the same meaning
  627  as provided in s. 409.901 and, for purposes of oversight of the
  628  integrity of the Medicaid program, also includes a participant
  629  in a Medicaid managed care provider network.
  630         (2) The agency shall conduct, or cause to be conducted by
  631  contract or otherwise, reviews, investigations, analyses,
  632  audits, or any combination thereof, to determine possible fraud,
  633  abuse, overpayment, or recipient neglect in the Medicaid program
  634  and shall report the findings of any overpayments in audit
  635  reports as appropriate. At least 5 percent of all audits must
  636  shall be conducted on a random basis. As part of its ongoing
  637  fraud detection activities, the agency shall identify and
  638  monitor, by contract or otherwise, patterns of overutilization
  639  of Medicaid services based on state averages. The agency shall
  640  track Medicaid provider prescription and billing patterns and
  641  evaluate them against Medicaid medical necessity criteria and
  642  coverage and limitation guidelines adopted by rule. Medical
  643  necessity determination requires that service be consistent with
  644  symptoms or confirmed diagnosis of illness or injury under
  645  treatment and not in excess of the patient’s needs. The agency
  646  shall conduct reviews of provider exceptions to peer group norms
  647  and shall, using statistical methodologies, provider profiling,
  648  and analysis of billing patterns, detect and investigate
  649  abnormal or unusual increases in billing or payment of claims
  650  for Medicaid services and medically unnecessary provision of
  651  services. The agency may review and analyze information from
  652  sources other than enrolled Medicaid providers in conducting its
  653  activities under this subsection.
  654         (9) A Medicaid provider shall retain medical, professional,
  655  financial, and business records pertaining to services and goods
  656  furnished to a Medicaid recipient and billed to Medicaid for 6 a
  657  period of 5 years after the date of furnishing such services or
  658  goods. The agency may investigate, review, or analyze such
  659  records, which must be made available during normal business
  660  hours. However, 24-hour notice must be provided if patient
  661  treatment would be disrupted. The provider is responsible for
  662  furnishing to the agency, and keeping the agency informed of the
  663  location of, the provider’s Medicaid-related records. The
  664  authority of the agency to obtain Medicaid-related records from
  665  a provider is neither curtailed nor limited during a period of
  666  litigation between the agency and the provider.
  667         (13) The agency shall immediately terminate participation
  668  of a Medicaid provider in the Medicaid program and may seek
  669  civil remedies or impose other administrative sanctions against
  670  a Medicaid provider, if the provider or any principal, officer,
  671  director, agent, managing employee, or affiliated person of the
  672  provider, or any partner or shareholder having an ownership
  673  interest in the provider equal to 5 percent or greater, has been
  674  convicted of a criminal offense under federal law or the law of
  675  any state relating to the practice of the provider’s profession,
  676  or a criminal offense listed under s. 409.907(10), s.
  677  408.809(4), or s. 435.04(2) has been:
  678         (a) Convicted of a criminal offense related to the delivery
  679  of any health care goods or services, including the performance
  680  of management or administrative functions relating to the
  681  delivery of health care goods or services;
  682         (b) Convicted of a criminal offense under federal law or
  683  the law of any state relating to the practice of the provider’s
  684  profession; or
  685         (c) Found by a court of competent jurisdiction to have
  686  neglected or physically abused a patient in connection with the
  687  delivery of health care goods or services. If the agency
  688  determines that the a provider did not participate or acquiesce
  689  in the an offense specified in paragraph (a), paragraph (b), or
  690  paragraph (c), termination will not be imposed. If the agency
  691  effects a termination under this subsection, the agency shall
  692  take final agency action issue an immediate final order pursuant
  693  to s. 120.569(2)(n).
  694         (15) The agency shall seek a remedy provided by law,
  695  including, but not limited to, any remedy provided in
  696  subsections (13) and (16) and s. 812.035, if:
  697         (a) The provider’s license has not been renewed, or has
  698  been revoked, suspended, or terminated, for cause, by the
  699  licensing agency of any state;
  700         (b) The provider has failed to make available or has
  701  refused access to Medicaid-related records to an auditor,
  702  investigator, or other authorized employee or agent of the
  703  agency, the Attorney General, a state attorney, or the Federal
  704  Government;
  705         (c) The provider has not furnished or has failed to make
  706  available such Medicaid-related records as the agency has found
  707  necessary to determine whether Medicaid payments are or were due
  708  and the amounts thereof;
  709         (d) The provider has failed to maintain medical records
  710  made at the time of service, or prior to service if prior
  711  authorization is required, demonstrating the necessity and
  712  appropriateness of the goods or services rendered;
  713         (e) The provider is not in compliance with provisions of
  714  Medicaid provider publications that have been adopted by
  715  reference as rules in the Florida Administrative Code; with
  716  provisions of state or federal laws, rules, or regulations; with
  717  provisions of the provider agreement between the agency and the
  718  provider; or with certifications found on claim forms or on
  719  transmittal forms for electronically submitted claims that are
  720  submitted by the provider or authorized representative, as such
  721  provisions apply to the Medicaid program;
  722         (f) The provider or person who ordered, authorized, or
  723  prescribed the care, services, or supplies has furnished, or
  724  ordered, or authorized the furnishing of, goods or services to a
  725  recipient which are inappropriate, unnecessary, excessive, or
  726  harmful to the recipient or are of inferior quality;
  727         (g) The provider has demonstrated a pattern of failure to
  728  provide goods or services that are medically necessary;
  729         (h) The provider or an authorized representative of the
  730  provider, or a person who ordered, authorized, or prescribed the
  731  goods or services, has submitted or caused to be submitted false
  732  or a pattern of erroneous Medicaid claims;
  733         (i) The provider or an authorized representative of the
  734  provider, or a person who has ordered, authorized, or prescribed
  735  the goods or services, has submitted or caused to be submitted a
  736  Medicaid provider enrollment application, a request for prior
  737  authorization for Medicaid services, a drug exception request,
  738  or a Medicaid cost report that contains materially false or
  739  incorrect information;
  740         (j) The provider or an authorized representative of the
  741  provider has collected from or billed a recipient or a
  742  recipient’s responsible party improperly for amounts that should
  743  not have been so collected or billed by reason of the provider’s
  744  billing the Medicaid program for the same service;
  745         (k) The provider or an authorized representative of the
  746  provider has included in a cost report costs that are not
  747  allowable under a Florida Title XIX reimbursement plan, after
  748  the provider or authorized representative had been advised in an
  749  audit exit conference or audit report that the costs were not
  750  allowable;
  751         (l) The provider is charged by information or indictment
  752  with fraudulent billing practices or any offense referenced in
  753  subsection (13). The sanction applied for this reason is limited
  754  to suspension of the provider’s participation in the Medicaid
  755  program for the duration of the indictment unless the provider
  756  is found guilty pursuant to the information or indictment;
  757         (m) The provider or a person who has ordered, authorized,
  758  or prescribed the goods or services is found liable for
  759  negligent practice resulting in death or injury to the
  760  provider’s patient;
  761         (n) The provider fails to demonstrate that it had available
  762  during a specific audit or review period sufficient quantities
  763  of goods, or sufficient time in the case of services, to support
  764  the provider’s billings to the Medicaid program;
  765         (o) The provider has failed to comply with the notice and
  766  reporting requirements of s. 409.907;
  767         (p) The agency has received reliable information of patient
  768  abuse or neglect or of any act prohibited by s. 409.920; or
  769         (q) The provider has failed to comply with an agreed-upon
  770  repayment schedule.
  771  
  772  A provider is subject to sanctions for violations of this
  773  subsection as the result of actions or inactions of the
  774  provider, or actions or inactions of any principal, officer,
  775  director, agent, managing employee, or affiliated person of the
  776  provider, or any partner or shareholder having an ownership
  777  interest in the provider equal to 5 percent or greater, in which
  778  the provider participated or acquiesced.
  779         (16) The agency shall impose any of the following sanctions
  780  or disincentives on a provider or a person for any of the acts
  781  described in subsection (15):
  782         (a) Suspension for a specific period of time of not more
  783  than 1 year. Suspension precludes shall preclude participation
  784  in the Medicaid program, which includes any action that results
  785  in a claim for payment to the Medicaid program as a result of
  786  furnishing, supervising a person who is furnishing, or causing a
  787  person to furnish goods or services.
  788         (b) Termination for a specific period of time of from more
  789  than 1 year to 20 years. Termination precludes shall preclude
  790  participation in the Medicaid program, which includes any action
  791  that results in a claim for payment to the Medicaid program as a
  792  result of furnishing, supervising a person who is furnishing, or
  793  causing a person to furnish goods or services.
  794         (c) Imposition of a fine of up to $5,000 for each
  795  violation. Each day that an ongoing violation continues, such as
  796  refusing to furnish Medicaid-related records or refusing access
  797  to records, is considered, for the purposes of this section, to
  798  be a separate violation. Each instance of improper billing of a
  799  Medicaid recipient; each instance of including an unallowable
  800  cost on a hospital or nursing home Medicaid cost report after
  801  the provider or authorized representative has been advised in an
  802  audit exit conference or previous audit report of the cost
  803  unallowability; each instance of furnishing a Medicaid recipient
  804  goods or professional services that are inappropriate or of
  805  inferior quality as determined by competent peer judgment; each
  806  instance of knowingly submitting a materially false or erroneous
  807  Medicaid provider enrollment application, request for prior
  808  authorization for Medicaid services, drug exception request, or
  809  cost report; each instance of inappropriate prescribing of drugs
  810  for a Medicaid recipient as determined by competent peer
  811  judgment; and each false or erroneous Medicaid claim leading to
  812  an overpayment to a provider is considered, for the purposes of
  813  this section, to be a separate violation.
  814         (d) Immediate suspension, if the agency has received
  815  information of patient abuse or neglect or of any act prohibited
  816  by s. 409.920. Upon suspension, the agency must issue an
  817  immediate final order under s. 120.569(2)(n).
  818         (e) A fine, not to exceed $10,000, for a violation of
  819  paragraph (15)(i).
  820         (f) Imposition of liens against provider assets, including,
  821  but not limited to, financial assets and real property, not to
  822  exceed the amount of fines or recoveries sought, upon entry of
  823  an order determining that such moneys are due or recoverable.
  824         (g) Prepayment reviews of claims for a specified period of
  825  time.
  826         (h) Comprehensive followup reviews of providers every 6
  827  months to ensure that they are billing Medicaid correctly.
  828         (i) Corrective-action plans that would remain in effect for
  829  providers for up to 3 years and that are would be monitored by
  830  the agency every 6 months while in effect.
  831         (j) Other remedies as permitted by law to effect the
  832  recovery of a fine or overpayment.
  833  
  834  If a provider voluntarily relinquishes its Medicaid provider
  835  number or an associated license, or allows the associated
  836  licensure to expire after receiving written notice that the
  837  agency is conducting, or has conducted, an audit, survey,
  838  inspection, or investigation and that the sanction of suspension
  839  or termination will be imposed for noncompliance discovered as a
  840  result of the audit, survey, inspection, or investigation, the
  841  agency shall impose the sanction of termination for cause
  842  against the provider. The Secretary of Health Care
  843  Administration may make a determination that imposition of a
  844  sanction or disincentive is not in the best interest of the
  845  Medicaid program, in which case a sanction or disincentive may
  846  shall not be imposed.
  847         (21) When making a determination that an overpayment has
  848  occurred, the agency shall prepare and issue an audit report to
  849  the provider showing the calculation of overpayments. The
  850  agency’s determination shall be based solely upon information
  851  available to it before issuance of the audit report and, in the
  852  case of documentation obtained to substantiate claims for
  853  Medicaid reimbursement, based solely upon contemporaneous
  854  records.
  855         (22) The audit report, supported by agency work papers,
  856  showing an overpayment to a provider constitutes evidence of the
  857  overpayment. A provider may not present or elicit testimony,
  858  either on direct examination or cross-examination in any court
  859  or administrative proceeding, regarding the purchase or
  860  acquisition by any means of drugs, goods, or supplies; sales or
  861  divestment by any means of drugs, goods, or supplies; or
  862  inventory of drugs, goods, or supplies, unless such acquisition,
  863  sales, divestment, or inventory is documented by written
  864  invoices, written inventory records, or other competent written
  865  documentary evidence maintained in the normal course of the
  866  provider’s business. A provider may not present records to
  867  contest an overpayment or sanction unless such records are
  868  contemporaneous and, if requested during the audit process, were
  869  furnished to the agency or its agent upon request or were
  870  furnished within 30 days after the provider received the final
  871  audit report. This limitation does not apply to Medicaid cost
  872  report audits. Notwithstanding the applicable rules of
  873  discovery, all documentation to that will be offered as evidence
  874  at an administrative hearing on a Medicaid overpayment or an
  875  administrative sanction must be exchanged by all parties at
  876  least 14 days before the administrative hearing or must be
  877  excluded from consideration.
  878         (25)(a) The agency shall withhold Medicaid payments, in
  879  whole or in part, to a provider upon receipt of reliable
  880  evidence that the circumstances giving rise to the need for a
  881  withholding of payments involve fraud, willful
  882  misrepresentation, or abuse under the Medicaid program, or a
  883  crime committed while rendering goods or services to Medicaid
  884  recipients. If it is determined that fraud, willful
  885  misrepresentation, abuse, or a crime did not occur, the payments
  886  withheld must be paid to the provider within 14 days after such
  887  determination with interest at the rate of 10 percent a year.
  888  Any money withheld in accordance with this paragraph shall be
  889  placed in a suspended account, readily accessible to the agency,
  890  so that any payment ultimately due the provider shall be made
  891  within 14 days.
  892         (b) The agency shall deny payment, or require repayment, if
  893  the goods or services were furnished, supervised, or caused to
  894  be furnished by a person who has been suspended or terminated
  895  from the Medicaid program or Medicare program by the Federal
  896  Government or any state.
  897         (c) Overpayments owed to the agency bear interest at the
  898  rate of 10 percent per year from the date of determination of
  899  the overpayment by the agency, and payment arrangements
  900  regarding overpayments and fines must be made within 30 days
  901  after the date of the final order and are not subject to further
  902  appeal at the conclusion of legal proceedings. A provider who
  903  does not enter into or adhere to an agreed-upon repayment
  904  schedule may be terminated by the agency for nonpayment or
  905  partial payment.
  906         (d) The agency, upon entry of a final agency order, a
  907  judgment or order of a court of competent jurisdiction, or a
  908  stipulation or settlement, may collect the moneys owed by all
  909  means allowable by law, including, but not limited to, notifying
  910  any fiscal intermediary of Medicare benefits that the state has
  911  a superior right of payment. Upon receipt of such written
  912  notification, the Medicare fiscal intermediary shall remit to
  913  the state the sum claimed.
  914         (e) The agency may institute amnesty programs to allow
  915  Medicaid providers the opportunity to voluntarily repay
  916  overpayments. The agency may adopt rules to administer such
  917  programs.
  918         (28) Venue for all Medicaid program integrity overpayment
  919  cases lies shall lie in Leon County, at the discretion of the
  920  agency.
  921         (29) Notwithstanding other provisions of law, the agency
  922  and the Medicaid Fraud Control Unit of the Department of Legal
  923  Affairs may review a person’s or provider’s Medicaid-related and
  924  non-Medicaid-related records in order to determine the total
  925  output of a provider’s practice to reconcile quantities of goods
  926  or services billed to Medicaid with quantities of goods or
  927  services used in the provider’s total practice.
  928         (30) The agency shall terminate a provider’s participation
  929  in the Medicaid program if the provider fails to reimburse an
  930  overpayment or pay a fine that has been determined by final
  931  order, not subject to further appeal, within 30 35 days after
  932  the date of the final order, unless the provider and the agency
  933  have entered into a repayment agreement.
  934         (31) If a provider requests an administrative hearing
  935  pursuant to chapter 120, such hearing must be conducted within
  936  90 days following assignment of an administrative law judge,
  937  absent exceptionally good cause shown as determined by the
  938  administrative law judge or hearing officer. Upon issuance of a
  939  final order, the outstanding balance of the amount determined to
  940  constitute the overpayment and fines is shall become due. If a
  941  provider fails to make payments in full, fails to enter into a
  942  satisfactory repayment plan, or fails to comply with the terms
  943  of a repayment plan or settlement agreement, the agency shall
  944  withhold medical assistance reimbursement payments for Medicaid
  945  services until the amount due is paid in full.
  946         Section 7. Subsection (8) of section 409.920, Florida
  947  Statutes, is amended to read:
  948         409.920 Medicaid provider fraud.—
  949         (8) A person who provides the state, any state agency, any
  950  of the state’s political subdivisions, or any agency of the
  951  state’s political subdivisions with information about fraud or
  952  suspected fraudulent acts fraud by a Medicaid provider,
  953  including a managed care organization, is immune from civil
  954  liability for libel, slander, or any other relevant tort for
  955  providing any the information about fraud or suspected
  956  fraudulent acts, unless the person acted with knowledge that the
  957  information was false or with reckless disregard for the truth
  958  or falsity of the information. For purposes of this subsection,
  959  the term “fraudulent acts” includes actual or suspected fraud,
  960  abuse, or overpayment, including any fraud-related matters that
  961  a provider or health plan is required to report to the agency or
  962  a law enforcement agency. The immunity from civil liability
  963  extends to reports of fraudulent acts conveyed to the agency in
  964  any manner, including any forum and with any audience as
  965  directed by the agency, and includes all discussions subsequent
  966  to the report and subsequent inquiries from the agency, unless
  967  the person acted with knowledge that the information was false
  968  or with reckless disregard for the truth or falsity of the
  969  information.
  970         Section 8. Paragraph (c) of subsection (2) of section
  971  409.967, Florida Statutes, is amended to read:
  972         409.967 Managed care plan accountability.—
  973         (2) The agency shall establish such contract requirements
  974  as are necessary for the operation of the statewide managed care
  975  program. In addition to any other provisions the agency may deem
  976  necessary, the contract must require:
  977         (c) Access.—
  978         1. Providers.—The agency shall establish specific standards
  979  for the number, type, and regional distribution of providers in
  980  managed care plan networks to ensure access to care for both
  981  adults and children. Each plan must maintain a regionwide
  982  network of providers in sufficient numbers to meet the access
  983  standards for specific medical services for all recipients
  984  enrolled in the plan. The exclusive use of mail-order pharmacies
  985  is may not be sufficient to meet network access standards.
  986  Consistent with the standards established by the agency,
  987  provider networks may include providers located outside the
  988  region. A plan may contract with a new hospital facility before
  989  the date the hospital becomes operational if the hospital has
  990  commenced construction, will be licensed and operational by
  991  January 1, 2013, and a final order has issued in any civil or
  992  administrative challenge. Each plan shall establish and maintain
  993  an accurate and complete electronic database of contracted
  994  providers, including information about licensure or
  995  registration, locations and hours of operation, specialty
  996  credentials and other certifications, specific performance
  997  indicators, and such other information as the agency deems
  998  necessary. The database must be available online to both the
  999  agency and the public and have the capability to compare the
 1000  availability of providers to network adequacy standards and to
 1001  accept and display feedback from each provider’s patients. Each
 1002  plan shall submit quarterly reports to the agency identifying
 1003  the number of enrollees assigned to each primary care provider.
 1004         2. Prescribed drugs.—
 1005         a. If establishing a prescribed drug formulary or preferred
 1006  drug list, a managed care plan must:
 1007         (I)Provide a broad range of therapeutic options for the
 1008  treatment of disease states consistent with the general needs of
 1009  an outpatient population. Whenever feasible, the formulary or
 1010  preferred drug list should include at least two products in a
 1011  therapeutic class;
 1012         (II)Include coverage via prior authorization for each drug
 1013  newly approved by the federal Food and Drug Administration until
 1014  the plan’s Pharmaceutical and Therapeutics Committee reviews
 1015  such drug for inclusion on the formulary. The timing of the
 1016  formulary review must comply with s. 409.91195; and
 1017         (III)Provide a response within 24 hours after receipt of
 1018  all necessary information from the medical provider for a
 1019  request for prior authorization and provide a procedure for
 1020  escalating a delayed prior authorization request to the pharmacy
 1021  management team for resolution or to override other medical
 1022  management tools.
 1023         b. Each managed care plan shall must publish any prescribed
 1024  drug formulary or preferred drug list on the plan’s website in a
 1025  manner that is accessible to and searchable by enrollees and
 1026  providers. The plan must update the list within 24 hours after
 1027  making a change. Each plan must ensure that the prior
 1028  authorization process for prescribed drugs is readily accessible
 1029  to health care providers, including posting appropriate contact
 1030  information on its website and providing timely responses to
 1031  providers.
 1032         c.The managed care plan must continue to permit an
 1033  enrollee who was receiving a prescription drug that was on the
 1034  plan’s formulary and subsequently removed or changed to continue
 1035  to receive that drug if the provider submits a written request
 1036  that demonstrates that the drug is medically necessary, and the
 1037  enrollee meets clinical criteria to receive the drug.
 1038         d.A managed care plan that imposes a step-therapy or a
 1039  fail-first protocol must do so in accordance with the following:
 1040         (I)If prescribed drugs for the treatment of a medical
 1041  condition are restricted for use by the plan through a step
 1042  therapy or fail-first protocol, the plan must provide the
 1043  prescriber with access to a clear and convenient process to
 1044  expeditiously request a prior authorization that includes a
 1045  procedure for escalation to the pharmacy management team if not
 1046  resolved in a timely manner.
 1047         (II)Escalation to the pharmacy management team must be
 1048  expeditiously granted by the plan if the prescriber can submit
 1049  appropriate and complete medical documentation to the plan that
 1050  the preferred treatment required under the step-therapy or fail
 1051  first protocol:
 1052         (A) Has been ineffective in the treatment of the enrollee’s
 1053  disease or medical condition;
 1054         (B) Is reasonably expected to be ineffective based on the
 1055  known relevant physical or mental characteristics and medical
 1056  history of the enrollee and known characteristics of the drug
 1057  regimen; or
 1058         (C) Will cause or will likely cause an adverse reaction or
 1059  other physical harm to the enrollee.
 1060         (III)The pharmacy management team shall work directly with
 1061  the medical provider to bring the prior-authorization request to
 1062  a clinically appropriate, cost-effective, and timely resolution.
 1063         e. For enrollees Medicaid recipients diagnosed with
 1064  hemophilia who have been prescribed anti-hemophilic-factor
 1065  replacement products, the agency shall provide for those
 1066  products and hemophilia overlay services through the agency’s
 1067  hemophilia disease management program.
 1068         3.Prior authorization.—
 1069         a. Each managed care plan must ensure that the prior
 1070  authorization process for prescribed drugs is readily accessible
 1071  to health care providers, including posting appropriate contact
 1072  information on its website and providing timely responses to
 1073  providers.
 1074         b. If a drug, determined to be medically necessary and
 1075  prescribed for an enrollee by a physician using sound clinical
 1076  judgment, is subject to prior authorization and approved, the
 1077  managed care plan must provide for sufficient refills to
 1078  complete the duration of the prescription. If the medication is
 1079  still clinically appropriate for ongoing therapy after the
 1080  initial prior authorization expires, the plan must provide a
 1081  process of expedited review to evaluate ongoing therapy.
 1082         c.If a prescribed drug requires prior authorization, the
 1083  managed care plan shall reimburse the pharmacist for dispensing
 1084  a 72-hour supply of oral maintenance medications to the enrollee
 1085  and process the prior authorization request. Dispensing a 72
 1086  hour supply must be consistent with laws that govern pharmacy
 1087  practice and controlled substances. The managed care plan shall
 1088  process all prior authorization requests in as timely a manner
 1089  as possible.
 1090         d.3. Managed care plans, and their fiscal agents or
 1091  intermediaries, must accept prior authorization requests for
 1092  prescribed drugs any service electronically.
 1093         Section 9. Subsection (11) is added to section 429.23,
 1094  Florida Statutes, to read:
 1095         429.23 Internal risk management and quality assurance
 1096  program; adverse incidents and reporting requirements.—
 1097         (11) The agency shall annually submit a report to the
 1098  Legislature on adverse incident reports by assisted living
 1099  facilities. The report must include the following information
 1100  arranged by county:
 1101         (a) A total number of adverse incidents;
 1102         (b) A listing, by category, of the type of adverse
 1103  incidents occurring within each category and the type of staff
 1104  involved;
 1105         (c) A listing, by category, of the types of injuries, if
 1106  any, and the number of injuries occurring within each category;
 1107         (d) Types of liability claims filed based on an adverse
 1108  incident report or reportable injury; and
 1109         (e) Disciplinary action taken against staff, categorized by
 1110  the type of staff involved.
 1111         Section 10. Present subsections (9), (10), and (11) of
 1112  section 429.26, Florida Statutes, are renumbered as subsections
 1113  (12), (13), and (14), respectively, and new subsections (9),
 1114  (10), and (11) are added to that section, to read:
 1115         429.26 Appropriateness of placements; examinations of
 1116  residents.—
 1117         (9) If, at any time after admission to a facility, agency
 1118  personnel question whether a resident needs care beyond that
 1119  which the facility is licensed to provide, the agency may
 1120  require the resident to be physically examined by a licensed
 1121  physician, licensed physician assistant, or certified nurse
 1122  practitioner. To the extent possible, the examination must be
 1123  performed by the resident’s preferred physician, physician
 1124  assistant, or nurse practitioner and paid for by the resident
 1125  with personal funds, except as provided in s. 429.18(2). This
 1126  subsection does not preclude the agency from imposing sanctions
 1127  for violations of subsection (1).
 1128         (a) Following examination, the examining physician,
 1129  physician assistant, or nurse practitioner shall complete and
 1130  sign a medical form provided by the agency. The completed
 1131  medical form must be submitted to the agency within 30 days
 1132  after the date the facility owner or administrator was notified
 1133  by the agency that a physical examination is required.
 1134         (b) A medical review team designated by the agency shall
 1135  determine whether the resident is appropriately residing in the
 1136  facility based on the completed medical form and, if necessary,
 1137  consultation with the physician, physician assistant, or nurse
 1138  practitioner who performed the examination. Members of the
 1139  medical review team making the determination may not include the
 1140  agency personnel who initially questioned the appropriateness of
 1141  the resident’s placement. The medical review team shall base its
 1142  decision on a comprehensive review of the resident’s physical
 1143  and functional status. A determination that the resident’s
 1144  placement is not appropriate is final and binding upon the
 1145  facility and the resident.
 1146         (c) A resident who is determined by the medical review team
 1147  to be inappropriately residing in a facility shall be given 30
 1148  days’ written notice to relocate by the owner or administrator,
 1149  unless the resident’s continued residence in the facility
 1150  presents an imminent danger to the health, safety, or welfare of
 1151  the resident or a substantial probability exists that death or
 1152  serious physical harm to the resident would result if the
 1153  resident is allowed to remain in the facility.
 1154         (10) If a mental health resident appears to have needs in
 1155  addition to those identified in the community living support
 1156  plan, the agency may require an evaluation by a mental health
 1157  professional, as determined by the Department of Children and
 1158  Family Services.
 1159         (11) A facility may not be required to retain a resident
 1160  who requires more services or care than the facility is able to
 1161  provide in accordance with its policies and criteria for
 1162  admission and continued residency.
 1163         Section 11. Effective July 1, 2012, section 456.0635,
 1164  Florida Statutes, is amended to read:
 1165         456.0635 Health care Medicaid fraud; disqualification for
 1166  license, certificate, or registration.—
 1167         (1) Health care Medicaid fraud in the practice of a health
 1168  care profession is prohibited.
 1169         (2) Each board under within the jurisdiction of the
 1170  department, or the department if there is no board, shall refuse
 1171  to admit a candidate to an any examination and refuse to issue
 1172  or renew a license, certificate, or registration to an any
 1173  applicant if the candidate or applicant or any principal,
 1174  officer, agent, managing employee, or affiliated person of the
 1175  applicant, has been:
 1176         (a) Has been convicted of, or entered a plea of guilty or
 1177  nolo contendere to, regardless of adjudication, a felony under
 1178  chapter 409, chapter 817, or chapter 893, or a similar felony
 1179  offense committed in another state or jurisdiction, unless the
 1180  candidate or applicant has successfully completed a drug court
 1181  program for that felony and provides proof that the plea has
 1182  been withdrawn or the charges have been dismissed. Any such
 1183  conviction or plea shall exclude the applicant or candidate from
 1184  licensure, examination, certification, or registration 21 U.S.C.
 1185  ss. 801-970, or 42 U.S.C. ss. 1395-1396, unless the sentence and
 1186  any subsequent period of probation for such conviction or plea
 1187  pleas ended: more than 15 years prior to the date of the
 1188  application;
 1189         1. For felonies of the first or second degree, more than 15
 1190  years before the date of application.
 1191         2. For felonies of the third degree, more than 10 years
 1192  before the date of application, except for felonies of the third
 1193  degree under s. 893.13(6)(a).
 1194         3. For felonies of the third degree under s. 893.13(6)(a),
 1195  more than 5 years before the date of application.
 1196         (b) Has been convicted of, or entered a plea of guilty or
 1197  nolo contendere to, regardless of adjudication, a felony under
 1198  21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396, unless the
 1199  sentence and any subsequent period of probation for such
 1200  conviction or plea ended more than 15 years before the date of
 1201  the application.
 1202         (c)(b)Has been terminated for cause from the Florida
 1203  Medicaid program pursuant to s. 409.913, unless the candidate or
 1204  applicant has been in good standing with the Florida Medicaid
 1205  program for the most recent 5 years.;
 1206         (d)(c)Has been terminated for cause, pursuant to the
 1207  appeals procedures established by the state or Federal
 1208  Government, from any other state Medicaid program or the federal
 1209  Medicare program, unless the candidate or applicant has been in
 1210  good standing with that a state Medicaid program or the federal
 1211  Medicare program for the most recent 5 years and the termination
 1212  occurred at least 20 years before prior to the date of the
 1213  application.
 1214         (e) Is currently listed on the United States Department of
 1215  Health and Human Services Office of Inspector General’s List of
 1216  Excluded Individuals and Entities.
 1217  
 1218  This subsection does not apply to candidates or applicants for
 1219  initial licensure or certification who were enrolled in an
 1220  educational or training program on or before July 1, 2009, which
 1221  was recognized by a board or, if there is no board, recognized
 1222  by the department, and who applied for licensure after July 1,
 1223  2012.
 1224         (3) The department shall refuse to renew a license,
 1225  certificate, or registration of any applicant if the applicant
 1226  or any principal, officer, agent, managing employee, or
 1227  affiliated person of the applicant:
 1228         (a) Has been convicted of, or entered a plea of guilty or
 1229  nolo contendere to, regardless of adjudication, a felony under
 1230  chapter 409, chapter 817, or chapter 893, or a similar felony
 1231  offense committed in another state or jurisdiction, unless the
 1232  applicant is currently enrolled in a drug court program that
 1233  allows the withdrawal of the plea for that felony upon
 1234  successful completion of that program. Any such conviction or
 1235  plea excludes the applicant or candidate from licensure,
 1236  examination, certification, or registration unless the sentence
 1237  and any subsequent period of probation for such conviction or
 1238  plea ended:
 1239         1. For felonies of the first or second degree, more than 15
 1240  years before the date of application.
 1241         2. For felonies of the third degree, more than 10 years
 1242  before the date of application, except for felonies of the third
 1243  degree under s. 893.13(6)(a).
 1244         3. For felonies of the third degree under s. 893.13(6)(a),
 1245  more than 5 years before the date of application.
 1246         (b) Has been convicted of, or entered a plea of guilty or
 1247  nolo contendere to, regardless of adjudication, a felony under
 1248  21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1,
 1249  2009, unless the sentence and any subsequent period of probation
 1250  for such conviction or plea ended more than 15 years before the
 1251  date of the application.
 1252         (c) Has been terminated for cause from the Florida Medicaid
 1253  program pursuant to s. 409.913, unless the applicant has been in
 1254  good standing with the Florida Medicaid program for the most
 1255  recent 5 years.
 1256         (d) Has been terminated for cause, pursuant to the appeals
 1257  procedures established by the state, from any other state
 1258  Medicaid program, unless the applicant has been in good standing
 1259  with that state Medicaid program for the most recent 5 years and
 1260  the termination occurred at least 20 years before the date of
 1261  the application.
 1262         (e) Is currently listed on the United States Department of
 1263  Health and Human Services Office of Inspector General’s List of
 1264  Excluded Individuals and Entities.
 1265         (4)(3) Licensed health care practitioners shall report
 1266  allegations of health care Medicaid fraud to the department,
 1267  regardless of the practice setting in which the alleged health
 1268  care Medicaid fraud occurred.
 1269         (5)(4) The acceptance by a licensing authority of a
 1270  licensee’s candidate’s relinquishment of a license which is
 1271  offered in response to or anticipation of the filing of
 1272  administrative charges alleging health care Medicaid fraud or
 1273  similar charges constitutes the permanent revocation of the
 1274  license.
 1275         Section 12. Effective July 1, 2012, present subsections
 1276  (14) and (15) of section 456.036, Florida Statutes, are
 1277  renumbered as subsections (15) and (16), respectively, and a new
 1278  subsection (14) is added to that section, to read:
 1279         456.036 Licenses; active and inactive status; delinquency.—
 1280         (14) A person who has been denied license renewal,
 1281  certification, or registration under s. 456.0635(3) may regain
 1282  licensure, certification, or registration only by meeting the
 1283  qualifications and completing the application process for
 1284  initial licensure as defined by the board, or the department if
 1285  there is no board. However, a person who was denied renewal of
 1286  licensure, certification, or registration under s. 24 of chapter
 1287  2009-223, Laws of Florida, between July 1, 2009, and June 30,
 1288  2012, is not required to retake and pass examinations applicable
 1289  for initial licensure, certification, or registration.
 1290         Section 13. Subsection (1) of section 456.074, Florida
 1291  Statutes, is amended to read:
 1292         456.074 Certain health care practitioners; immediate
 1293  suspension of license.—
 1294         (1) The department shall issue an emergency order
 1295  suspending the license of any person licensed under chapter 458,
 1296  chapter 459, chapter 460, chapter 461, chapter 462, chapter 463,
 1297  chapter 464, chapter 465, chapter 466, or chapter 484 who pleads
 1298  guilty to, is convicted or found guilty of, or who enters a plea
 1299  of nolo contendere to, regardless of adjudication, to:
 1300         (a) A felony under chapter 409, chapter 817, or chapter 893
 1301  or under 21 U.S.C. ss. 801-970 or under 42 U.S.C. ss. 1395-1396;
 1302  or
 1303         (b) A misdemeanor or felony under 18 U.S.C. s. 669, ss.
 1304  285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s.
 1305  1349, or s. 1518 or 42 U.S.C. ss. 1320a-7b, relating to the
 1306  Medicaid program.
 1307         Section 14. Subsection (3) of section 458.309, Florida
 1308  Statutes, is amended to read:
 1309         458.309 Rulemaking authority.—
 1310         (3) A physician All physicians who performs liposuction
 1311  procedures in which more than 1,000 cubic centimeters of
 1312  supernatant fat is removed, perform level 2 procedures lasting
 1313  more than 5 minutes, and all level 3 surgical procedures in an
 1314  office setting must register the office with the department
 1315  unless that office is licensed as a facility under pursuant to
 1316  chapter 395. The department shall inspect the physician’s office
 1317  annually unless the office is accredited by a nationally
 1318  recognized accrediting agency or an accrediting organization
 1319  subsequently approved by the Board of Medicine. The actual costs
 1320  for registration and inspection or accreditation shall be paid
 1321  by the person seeking to register and operate the office setting
 1322  in which office surgery is performed.
 1323         Section 15. Subsection (2) of section 459.005, Florida
 1324  Statutes, is amended to read:
 1325         459.005 Rulemaking authority.—
 1326         (2) A physician All physicians who performs liposuction
 1327  procedures in which more than 1,000 cubic centimeters of
 1328  supernatant fat is removed, perform level 2 procedures lasting
 1329  more than 5 minutes, and all level 3 surgical procedures in an
 1330  office setting must register the office with the department
 1331  unless that office is licensed as a facility under pursuant to
 1332  chapter 395. The department shall inspect the physician’s office
 1333  annually unless the office is accredited by a nationally
 1334  recognized accrediting agency or an accrediting organization
 1335  subsequently approved by the Board of Osteopathic Medicine. The
 1336  actual costs for registration and inspection or accreditation
 1337  shall be paid by the person seeking to register and operate the
 1338  office setting in which office surgery is performed.
 1339         Section 16. Subsections (3), (4), and (5) of section
 1340  463.002, Florida Statutes, are amended to read:
 1341         463.002 Definitions.—As used in this chapter, the term:
 1342         (3)(a) “Licensed practitioner” means a person who is a
 1343  primary health care provider licensed to engage in the practice
 1344  of optometry under the authority of this chapter.
 1345         (b) A licensed practitioner who is not a certified
 1346  optometrist shall be required to display at her or his place of
 1347  practice a sign which states, “I am a Licensed Practitioner, not
 1348  a Certified Optometrist, and I am not able to prescribe topical
 1349  ocular pharmaceutical agents.”
 1350         (c) All practitioners initially licensed after July 1,
 1351  1993, must be certified optometrists.
 1352         (4) “Certified optometrist” means a licensed practitioner
 1353  authorized by the board to administer and prescribe topical
 1354  ocular pharmaceutical agents.
 1355         (5) “Optometry” means the diagnosis of conditions of the
 1356  human eye and its appendages; the employment of any objective or
 1357  subjective means or methods, including the administration of
 1358  topical ocular pharmaceutical agents, for the purpose of
 1359  determining the refractive powers of the human eyes, or any
 1360  visual, muscular, neurological, or anatomic anomalies of the
 1361  human eyes and their appendages; and the prescribing and
 1362  employment of lenses, prisms, frames, mountings, contact lenses,
 1363  orthoptic exercises, light frequencies, and any other means or
 1364  methods, including topical ocular pharmaceutical agents, for the
 1365  correction, remedy, or relief of any insufficiencies or abnormal
 1366  conditions of the human eyes and their appendages.
 1367         Section 17. Paragraph (g) of subsection (1) of section
 1368  463.005, Florida Statutes, is amended to read:
 1369         463.005 Authority of the board.—
 1370         (1) The Board of Optometry has authority to adopt rules
 1371  pursuant to ss. 120.536(1) and 120.54 to implement the
 1372  provisions of this chapter conferring duties upon it. Such rules
 1373  shall include, but not be limited to, rules relating to:
 1374         (g) Administration and prescription of topical ocular
 1375  pharmaceutical agents.
 1376         Section 18. Section 463.0055, Florida Statutes, is amended
 1377  to read:
 1378         463.0055 Administration and prescription of topical ocular
 1379  pharmaceutical agents; committee.—
 1380         (1)(a) Certified optometrists may administer and prescribe
 1381  topical ocular pharmaceutical agents as provided in this section
 1382  for the diagnosis and treatment of ocular conditions of the
 1383  human eye and its appendages without the use of surgery or other
 1384  invasive techniques. However, a licensed practitioner who is not
 1385  certified may use topically applied anesthetics solely for the
 1386  purpose of glaucoma examinations, but is otherwise prohibited
 1387  from administering or prescribing topical ocular pharmaceutical
 1388  agents.
 1389         (b) Before a certified optometrist may administer or
 1390  prescribe oral ocular pharmaceutical agents, the certified
 1391  optometrist must complete a course and subsequent examination on
 1392  general and ocular pharmacology which have a particular emphasis
 1393  on the ingestion of oral pharmaceutical agents and the side
 1394  effects of those agents. For certified optometrists licensed
 1395  before January 1, 1990, the course shall consist of 50 contact
 1396  hours and 25 of those hours shall be Internet-based. For
 1397  certified optometrists licensed on or after January 1, 1990, the
 1398  course shall consist of 20 contact hours and 10 of those hours
 1399  shall be Internet-based. The first course and examination shall
 1400  be presented by January 1, 2013, and shall thereafter be
 1401  administered at least annually. The Florida Medical Association
 1402  and the Florida Optometric Association shall jointly develop and
 1403  administer a course and examination for such purpose and jointly
 1404  determine the site or sites for the course and examination.
 1405         (2)(a) There is hereby created a committee composed of two
 1406  certified optometrists licensed pursuant to this chapter,
 1407  appointed by the Board of Optometry, two board-certified
 1408  ophthalmologists licensed pursuant to chapter 458 or chapter
 1409  459, appointed by the Board of Medicine, and one additional
 1410  person with a doctorate degree in pharmacology who is not
 1411  licensed pursuant to chapter 458, chapter 459, or this chapter,
 1412  appointed by the State Surgeon General. The committee shall
 1413  review requests for additions to, deletions from, or
 1414  modifications of a formulary of topical ocular pharmaceutical
 1415  agents for administration and prescription by certified
 1416  optometrists and shall provide to the board advisory opinions
 1417  and recommendations on such requests. The formulary of topical
 1418  ocular pharmaceutical agents shall consist of those topical
 1419  ocular pharmaceutical agents that are appropriate to treat and
 1420  diagnose ocular diseases and disorders and that which the
 1421  certified optometrist is qualified to use in the practice of
 1422  optometry. The board shall establish, add to, delete from, or
 1423  modify the formulary by rule. Notwithstanding any provision of
 1424  chapter 120 to the contrary, the formulary rule shall become
 1425  effective 60 days from the date it is filed with the Secretary
 1426  of State.
 1427         (b) The topical formulary may be added to, deleted from, or
 1428  modified according to the procedure described in paragraph (a).
 1429  Any person who requests an addition, deletion, or modification
 1430  of an authorized topical ocular pharmaceutical agent shall have
 1431  the burden of proof to show cause why such addition, deletion,
 1432  or modification should be made.
 1433         (c) The State Surgeon General shall have standing to
 1434  challenge any rule or proposed rule of the board pursuant to s.
 1435  120.56. In addition to challenges for any invalid exercise of
 1436  delegated legislative authority, the administrative law judge,
 1437  upon such a challenge by the State Surgeon General, may declare
 1438  all or part of a rule or proposed rule invalid if it:
 1439         1. Does not protect the public from any significant and
 1440  discernible harm or damages;
 1441         2. Unreasonably restricts competition or the availability
 1442  of professional services in the state or in a significant part
 1443  of the state; or
 1444         3. Unnecessarily increases the cost of professional
 1445  services without a corresponding or equivalent public benefit.
 1446  
 1447  However, there shall not be created a presumption of the
 1448  existence of any of the conditions cited in this subsection in
 1449  the event that the rule or proposed rule is challenged.
 1450         (d) Upon adoption of the topical formulary required by this
 1451  section, and upon each addition, deletion, or modification to
 1452  the topical formulary, the board shall mail a copy of the
 1453  amended topical formulary to each certified optometrist and to
 1454  each pharmacy licensed by the state.
 1455         (3) In addition to the formulary of topical ocular
 1456  pharmaceutical agents in subsection (2), a statutory formulary
 1457  of oral pharmaceutical agents is established, which includes the
 1458  following agents:
 1459         (a) The following analgesics, or their generic or
 1460  therapeutic equivalents, which may not be administered or
 1461  prescribed for more than 72 hours:
 1462         1. Tramadol hydrochloride.
 1463         2. Acetaminophen 300 mg with No. 3 codeine phosphate 30 mg.
 1464  
 1465  If any of the oral analgesic agents set forth in this paragraph
 1466  are administered or prescribed, the certified optometrists must
 1467  immediately notify the patient’s primary care physician or a
 1468  physician licensed under chapter 458 or chapter 459 who is
 1469  skilled in diseases of the eye.
 1470         (b) The following antibiotics, or their generic or
 1471  therapeutic equivalents:
 1472         1. Amoxicillin.
 1473         2. Azithromycin.
 1474         3. Ciproflaxacin.
 1475         4. Dicloxacillin.
 1476         5. Doxycycline.
 1477         6. Keflex.
 1478         7. Minocycline.
 1479         (c) The following antivirals, or their generic or
 1480  therapeutic equivalents:
 1481         1. Acyclovir.
 1482         2. Famciclovir.
 1483         3. Valacyclovir.
 1484         (d) The following oral anti-glaucoma agents, or their
 1485  generic or therapeutic equivalents, which may not be
 1486  administered or prescribed for more than 72 hours:
 1487         1. Acetazolamide.
 1488         2. Methazolamide.
 1489  
 1490  If any of the oral anti-glaucoma agents set forth in this
 1491  paragraph are administered or prescribed, the certified
 1492  optometrist must immediately notify the patient’s primary care
 1493  physician or a physician licensed under chapter 458 or chapter
 1494  459 who is skilled in diseases of the eye.
 1495  
 1496  Any oral pharmaceutical agent listed in the statutory formulary
 1497  set forth in this subsection which is subsequently determined by
 1498  the United States Food and Drug Administration to be unsafe for
 1499  administration or prescription shall be considered to have been
 1500  deleted from the formulary of oral pharmaceutical agents. The
 1501  oral pharmaceutical agents on the statutory formulary set forth
 1502  in this subsection may not otherwise be deleted by the board,
 1503  the department, or the State Surgeon General.
 1504         (4)(3) A certified optometrist shall be issued a prescriber
 1505  number by the board. Any prescription written by a certified
 1506  optometrist for a topical ocular pharmaceutical agent pursuant
 1507  to this section shall have the prescriber number printed
 1508  thereon.
 1509         Section 19. Subsection (3) of section 463.0057, Florida
 1510  Statutes, is amended to read:
 1511         463.0057 Optometric faculty certificate.—
 1512         (3) The holder of a faculty certificate may engage in the
 1513  practice of optometry as permitted by this section, but may not
 1514  administer or prescribe topical ocular pharmaceutical agents
 1515  unless the certificateholder has satisfied the requirements of
 1516  ss. 463.0055(1)(b) and s. 463.006(1)(b)4. and 5.
 1517         Section 20. Subsections (2) and (3) of section 463.006,
 1518  Florida Statutes, are amended to read:
 1519         463.006 Licensure and certification by examination.—
 1520         (2) The examination shall consist of the appropriate
 1521  subjects, including applicable state laws and rules and general
 1522  and ocular pharmacology with emphasis on the use topical
 1523  application and side effects of ocular pharmaceutical agents.
 1524  The board may by rule substitute a national examination as part
 1525  or all of the examination and may by rule offer a practical
 1526  examination in addition to the written examination.
 1527         (3) Each applicant who successfully passes the examination
 1528  and otherwise meets the requirements of this chapter is entitled
 1529  to be licensed as a practitioner and to be certified to
 1530  administer and prescribe topical ocular pharmaceutical agents in
 1531  the diagnosis and treatment of ocular conditions.
 1532         Section 21. Subsections (1) and (2) of section 463.0135,
 1533  Florida Statutes, are amended, and subsection (10) is added to
 1534  that section, to read:
 1535         463.0135 Standards of practice.—
 1536         (1) A licensed practitioner shall provide that degree of
 1537  care which conforms to that level of care provided by medical
 1538  practitioners in the same or similar communities. A certified
 1539  optometrist shall administer and prescribe oral ocular
 1540  pharmaceutical agents in a manner consistent with applicable
 1541  preferred practice patterns of the American Academy of
 1542  Ophthalmology. A licensed practitioner shall advise or assist
 1543  her or his patient in obtaining further care when the service of
 1544  another health care practitioner is required.
 1545         (2) A licensed practitioner diagnosing angle closure,
 1546  neovascular, infantile, or congenital forms of glaucoma shall
 1547  promptly and without unreasonable delay refer the patient to a
 1548  physician skilled in diseases of the eye and licensed under
 1549  chapter 458 or chapter 459. In addition, a licensed practitioner
 1550  shall timely refer any patient who experiences progressive
 1551  glaucoma due to failed pharmaceutical intervention to a
 1552  physician who is skilled in diseases of the eye and licensed
 1553  under chapter 458 or chapter 459.
 1554         (10) Comanagement of postoperative care shall be conducted
 1555  pursuant to an established protocol that governs the
 1556  relationship between the operating surgeon and the optometrist.
 1557  The patient shall be informed that either physician will be
 1558  available for emergency care throughout the postoperative
 1559  period, and the patient shall consent in writing to the
 1560  comanagement relationship.
 1561         Section 22. Subsections (3) and (4) of section 463.014,
 1562  Florida Statutes, are amended to read:
 1563         463.014 Certain acts prohibited.—
 1564         (3) Prescribing, ordering, dispensing, administering,
 1565  supplying, selling, or giving any systemic drugs for the purpose
 1566  of treating a systemic disease by a licensed practitioner is
 1567  prohibited. However, a certified optometrist is permitted to use
 1568  commonly accepted means or methods to immediately address
 1569  incidents of anaphylaxis.
 1570         (4) Surgery of any kind, including the use of lasers, is
 1571  expressly prohibited. For purposes of this subsection, the term
 1572  “surgery” means a procedure using an instrument, including
 1573  lasers, scalpels, or needles, in which human tissue is cut,
 1574  burned, or vaporized by incision, injection, ultrasound, laser,
 1575  or radiation. The term includes procedures using instruments
 1576  that require closing by suturing, clamping, or another such
 1577  device. Certified optometrists may remove superficial foreign
 1578  bodies. For the purposes of this subsection, the term
 1579  “superficial foreign bodies” means any foreign matter that is
 1580  embedded in the conjunctiva or cornea but which has not
 1581  penetrated the globe.
 1582         Section 23. Section 463.0141, Florida Statutes, is created
 1583  to read:
 1584         463.0141Reports of adverse incidents in the practice of
 1585  optometry.—
 1586         (1) Any adverse incident that occurs on or after January 1,
 1587  2013, in the practice of optometry must be reported to the
 1588  department in the accordance with this section.
 1589         (2) The required notification to the department must be
 1590  submitted in writing by certified mail and postmarked within 15
 1591  days after the occurrence of the adverse incident.
 1592         (3) For purposes of notification to the department, the
 1593  term “adverse incident,” as used in this section, means an event
 1594  that is associated in whole or in part with the prescribing of
 1595  an oral ocular pharmaceutical agent and that results in one of
 1596  the following:
 1597         (a) Any condition that requires the transfer of a patient
 1598  to a hospital licensed under chapter 395;
 1599         (b) Any condition that requires the patient to obtain care
 1600  from a physician licensed under chapter 458 or chapter 459,
 1601  other than a referral or a consultation required under this
 1602  chapter;
 1603         (c) Permanent physical injury to the patient;
 1604         (d) Partial or complete permanent loss of sight by the
 1605  patient; or
 1606         (e) Death of the patient.
 1607         (4) The department shall review each incident and determine
 1608  whether it potentially involved conduct by the licensed
 1609  practitioner which may be subject to disciplinary action, in
 1610  which case s. 456.073 applies. Disciplinary action, if any,
 1611  shall be taken by the board.
 1612         Section 24. Subsection (1) of section 483.035, Florida
 1613  Statutes, is amended to read:
 1614         483.035 Clinical laboratories operated by practitioners for
 1615  exclusive use; licensure and regulation.—
 1616         (1) A clinical laboratory operated by one or more
 1617  practitioners licensed under chapter 458, chapter 459, chapter
 1618  460, chapter 461, chapter 462, chapter 463, or chapter 466,
 1619  exclusively in connection with the diagnosis and treatment of
 1620  their own patients, must be licensed under this part and must
 1621  comply with the provisions of this part, except that the agency
 1622  shall adopt rules for staffing, for personnel, including
 1623  education and training of personnel, for proficiency testing,
 1624  and for construction standards relating to the licensure and
 1625  operation of the laboratory based upon and not exceeding the
 1626  same standards contained in the federal Clinical Laboratory
 1627  Improvement Amendments of 1988 and the federal regulations
 1628  adopted thereunder.
 1629         Section 25. Subsection (7) of section 483.041, Florida
 1630  Statutes, is amended to read:
 1631         483.041 Definitions.—As used in this part, the term:
 1632         (7) “Licensed practitioner” means a physician licensed
 1633  under chapter 458, chapter 459, chapter 460, or chapter 461, or
 1634  chapter 463; a dentist licensed under chapter 466; a person
 1635  licensed under chapter 462; or an advanced registered nurse
 1636  practitioner licensed under part I of chapter 464; or a duly
 1637  licensed practitioner from another state licensed under similar
 1638  statutes who orders examinations on materials or specimens for
 1639  nonresidents of the State of Florida, but who reside in the same
 1640  state as the requesting licensed practitioner.
 1641         Section 26. Subsection (5) of section 483.181, Florida
 1642  Statutes, is amended to read:
 1643         483.181 Acceptance, collection, identification, and
 1644  examination of specimens.—
 1645         (5) A clinical laboratory licensed under this part must
 1646  accept a human specimen submitted for examination by a
 1647  practitioner licensed under chapter 458, chapter 459, chapter
 1648  460, chapter 461, chapter 462, chapter 463, s. 464.012, or
 1649  chapter 466, if the specimen and test are the type performed by
 1650  the clinical laboratory. A clinical laboratory may only refuse a
 1651  specimen based upon a history of nonpayment for services by the
 1652  practitioner. A clinical laboratory shall not charge different
 1653  prices for tests based upon the chapter under which a
 1654  practitioner submitting a specimen for testing is licensed.
 1655         Section 27. Paragraph (a) of subsection (54) of section
 1656  499.003, Florida Statutes, is amended to read:
 1657         499.003 Definitions of terms used in this part.—As used in
 1658  this part, the term:
 1659         (54) “Wholesale distribution” means distribution of
 1660  prescription drugs to persons other than a consumer or patient,
 1661  but does not include:
 1662         (a) Any of the following activities, which is not a
 1663  violation of s. 499.005(21) if such activity is conducted in
 1664  accordance with s. 499.01(2)(g):
 1665         1. The purchase or other acquisition by a hospital or other
 1666  health care entity that is a member of a group purchasing
 1667  organization of a prescription drug for its own use from the
 1668  group purchasing organization or from other hospitals or health
 1669  care entities that are members of that organization.
 1670         2. The sale, purchase, or trade of a prescription drug or
 1671  an offer to sell, purchase, or trade a prescription drug by a
 1672  charitable organization described in s. 501(c)(3) of the
 1673  Internal Revenue Code of 1986, as amended and revised, to a
 1674  nonprofit affiliate of the organization to the extent otherwise
 1675  permitted by law.
 1676         3. The sale, purchase, or trade of a prescription drug or
 1677  an offer to sell, purchase, or trade a prescription drug among
 1678  hospitals or other health care entities that are under common
 1679  control. For purposes of this subparagraph, “common control”
 1680  means the power to direct or cause the direction of the
 1681  management and policies of a person or an organization, whether
 1682  by ownership of stock, by voting rights, by contract, or
 1683  otherwise.
 1684         4. The sale, purchase, trade, or other transfer of a
 1685  prescription drug from or for any federal, state, or local
 1686  government agency or any entity eligible to purchase
 1687  prescription drugs at public health services prices pursuant to
 1688  Pub. L. No. 102-585, s. 602 to a contract provider or its
 1689  subcontractor for eligible patients of the agency or entity
 1690  under the following conditions:
 1691         a. The agency or entity must obtain written authorization
 1692  for the sale, purchase, trade, or other transfer of a
 1693  prescription drug under this subparagraph from the State Surgeon
 1694  General or his or her designee.
 1695         b. The contract provider or subcontractor must be
 1696  authorized by law to administer or dispense prescription drugs.
 1697         c. In the case of a subcontractor, the agency or entity
 1698  must be a party to and execute the subcontract.
 1699         d. A contract provider or subcontractor must maintain
 1700  separate and apart from other prescription drug inventory any
 1701  prescription drugs of the agency or entity in its possession.
 1702         d.e. The contract provider and subcontractor must maintain
 1703  and produce immediately for inspection all records of movement
 1704  or transfer of all the prescription drugs belonging to the
 1705  agency or entity, including, but not limited to, the records of
 1706  receipt and disposition of prescription drugs. Each contractor
 1707  and subcontractor dispensing or administering these drugs must
 1708  maintain and produce records documenting the dispensing or
 1709  administration. Records that are required to be maintained
 1710  include, but are not limited to, a perpetual inventory itemizing
 1711  drugs received and drugs dispensed by prescription number or
 1712  administered by patient identifier, which must be submitted to
 1713  the agency or entity quarterly.
 1714         e.f. The contract provider or subcontractor may administer
 1715  or dispense the prescription drugs only to the eligible patients
 1716  of the agency or entity or must return the prescription drugs
 1717  for or to the agency or entity. The contract provider or
 1718  subcontractor must require proof from each person seeking to
 1719  fill a prescription or obtain treatment that the person is an
 1720  eligible patient of the agency or entity and must, at a minimum,
 1721  maintain a copy of this proof as part of the records of the
 1722  contractor or subcontractor required under sub-subparagraph e.
 1723         f.g. In addition to the departmental inspection authority
 1724  set forth in s. 499.051, the establishment of the contract
 1725  provider and subcontractor and all records pertaining to
 1726  prescription drugs subject to this subparagraph shall be subject
 1727  to inspection by the agency or entity. All records relating to
 1728  prescription drugs of a manufacturer under this subparagraph
 1729  shall be subject to audit by the manufacturer of those drugs,
 1730  without identifying individual patient information.
 1731         Section 28. Subsection (4) of section 766.102, Florida
 1732  Statutes, is amended to read:
 1733         766.102 Medical negligence; standards of recovery; expert
 1734  witness.—
 1735         (4)(a) The Legislature is cognizant of the changing trends
 1736  and techniques for the delivery of health care in this state and
 1737  the discretion that is inherent in the diagnosis, care, and
 1738  treatment of patients by different health care providers. The
 1739  failure of a health care provider to order, perform, or
 1740  administer supplemental diagnostic tests is shall not be
 1741  actionable if the health care provider acted in good faith and
 1742  with due regard for the prevailing professional standard of
 1743  care.
 1744         (b) The claimant has the burden of proving by clear and
 1745  convincing evidence that the alleged actions of the health care
 1746  provider represent a breach of the prevailing professional
 1747  standard of care in an action for damages based on death or
 1748  personal injury which alleges that the death or injury resulted
 1749  from the failure of a health care provider to order, perform, or
 1750  administer supplemental diagnostic tests.
 1751         Section 29. Paragraph (b) of subsection (6) of section
 1752  766.106, Florida Statutes, is amended to read:
 1753         766.106 Notice before filing action for medical negligence;
 1754  presuit screening period; offers for admission of liability and
 1755  for arbitration; informal discovery; review.—
 1756         (6) INFORMAL DISCOVERY.—
 1757         (b) Informal discovery may be used by a party to obtain
 1758  unsworn statements, the production of documents or things, and
 1759  physical and mental examinations, and ex parte interviews, as
 1760  follows:
 1761         1. Unsworn statements.—Any party may require other parties
 1762  to appear for the taking of an unsworn statement. Such
 1763  statements may be used only for the purpose of presuit screening
 1764  and are not discoverable or admissible in any civil action for
 1765  any purpose by any party. A party desiring to take the unsworn
 1766  statement of any party must give reasonable notice in writing to
 1767  all parties. The notice must state the time and place for taking
 1768  the statement and the name and address of the party to be
 1769  examined. Unless otherwise impractical, the examination of any
 1770  party must be done at the same time by all other parties. Any
 1771  party may be represented by counsel at the taking of an unsworn
 1772  statement. An unsworn statement may be recorded electronically,
 1773  stenographically, or on videotape. The taking of unsworn
 1774  statements is subject to the provisions of the Florida Rules of
 1775  Civil Procedure and may be terminated for abuses.
 1776         2. Documents or things.—Any party may request discovery of
 1777  documents or things. The documents or things must be produced,
 1778  at the expense of the requesting party, within 20 days after the
 1779  date of receipt of the request. A party is required to produce
 1780  discoverable documents or things within that party’s possession
 1781  or control. Medical records shall be produced as provided in s.
 1782  766.204.
 1783         3. Physical and mental examinations.—A prospective
 1784  defendant may require an injured claimant to appear for
 1785  examination by an appropriate health care provider. The
 1786  prospective defendant shall give reasonable notice in writing to
 1787  all parties as to the time and place for examination. Unless
 1788  otherwise impractical, a claimant is required to submit to only
 1789  one examination on behalf of all potential defendants. The
 1790  practicality of a single examination must be determined by the
 1791  nature of the claimant’s condition, as it relates to the
 1792  liability of each prospective defendant. Such examination report
 1793  is available to the parties and their attorneys upon payment of
 1794  the reasonable cost of reproduction and may be used only for the
 1795  purpose of presuit screening. Otherwise, such examination report
 1796  is confidential and exempt from the provisions of s. 119.07(1)
 1797  and s. 24(a), Art. I of the State Constitution.
 1798         4. Written questions.—Any party may request answers to
 1799  written questions, the number of which may not exceed 30,
 1800  including subparts. A response must be made within 20 days after
 1801  receipt of the questions.
 1802         5. Unsworn statements of treating health care providers.—A
 1803  prospective defendant or his or her legal representative may
 1804  also take unsworn statements of the claimant’s treating health
 1805  care providers. The statements must be limited to those areas
 1806  that are potentially relevant to the claim of personal injury or
 1807  wrongful death. Subject to the procedural requirements of
 1808  subparagraph 1., a prospective defendant may take unsworn
 1809  statements from a claimant’s treating physicians. Reasonable
 1810  notice and opportunity to be heard must be given to the claimant
 1811  or the claimant’s legal representative before taking unsworn
 1812  statements. The claimant or claimant’s legal representative has
 1813  the right to attend the taking of such unsworn statements.
 1814         6. Ex parte interviews of treating health care providers.—A
 1815  prospective defendant or his or her legal representative may
 1816  interview the claimant’s treating health care providers without
 1817  the presence of the claimant or the claimant’s legal
 1818  representative. If a prospective defendant or his or her legal
 1819  representative intends to interview a claimant’s health care
 1820  providers, the prospective defendant must provide the claimant
 1821  with notice of such interview at least 10 days before the date
 1822  of the interview.
 1823         Section 30. Subsection (21) of section 893.02, Florida
 1824  Statutes, is amended to read:
 1825         893.02 Definitions.—The following words and phrases as used
 1826  in this chapter shall have the following meanings, unless the
 1827  context otherwise requires:
 1828         (21) “Practitioner” means a physician licensed pursuant to
 1829  chapter 458, a dentist licensed pursuant to chapter 466, a
 1830  veterinarian licensed pursuant to chapter 474, an osteopathic
 1831  physician licensed pursuant to chapter 459, a naturopath
 1832  licensed pursuant to chapter 462, a certified optometrist
 1833  licensed under chapter 463, or a podiatric physician licensed
 1834  pursuant to chapter 461, provided such practitioner holds a
 1835  valid federal controlled substance registry number.
 1836         Section 31. Subsection (1) of section 893.05, Florida
 1837  Statutes, is amended to read:
 1838         893.05 Practitioners and persons administering controlled
 1839  substances in their absence.—
 1840         (1) A practitioner, in good faith and in the course of his
 1841  or her professional practice only, may prescribe, administer,
 1842  dispense, mix, or otherwise prepare a controlled substance, or
 1843  the practitioner may cause the same to be administered by a
 1844  licensed nurse or an intern practitioner under his or her
 1845  direction and supervision only. A veterinarian may so prescribe,
 1846  administer, dispense, mix, or prepare a controlled substance for
 1847  use on animals only, and may cause it to be administered by an
 1848  assistant or orderly under the veterinarian’s direction and
 1849  supervision only. A certified optometrist licensed under chapter
 1850  463 may not administer or prescribe pharmaceutical agents in
 1851  Schedule I or Schedule II of the Florida Comprehensive Drug
 1852  Abuse Prevention and Control Act.
 1853         Section 32. The Agency for Health Care Administration shall
 1854  prepare a report within 18 months after the implementation of an
 1855  expansion of managed care to new populations or the provision of
 1856  new items and services. The agency shall post a draft of the
 1857  report on its website and provide an opportunity for public
 1858  comment. The final report shall be submitted to the Legislature,
 1859  along with a description of the process for public input. The
 1860  report must include an assessment of:
 1861         (1) The impact of managed care on patient access to care,
 1862  including an evaluation of any new barriers to the use of
 1863  services and prescription drugs, created by the use of medical
 1864  management or cost-containment tools.
 1865         (2) The impact of the increased managed care expansion on
 1866  the utilization of services, quality of care, and patient
 1867  outcomes.
 1868         (3) The use of prior authorization and other utilization
 1869  management tools, including an assessment of whether these tools
 1870  pose an undue administrative burden for health care providers or
 1871  create barriers to needed care.
 1872         Section 33. If any provision of this act or its application
 1873  to any person or circumstance is held invalid, the invalidity
 1874  does not affect other provisions or applications of the act
 1875  which can be given effect without the invalid provision or
 1876  application, and to this end the provisions of this act are
 1877  severable.
 1878         Section 34. Except as otherwise expressly provided in this
 1879  act, this act shall take effect upon becoming a law.