Florida Senate - 2016                       CS for CS for SB 212
       
       
        
       By the Committees on Appropriations; and Health Policy; and
       Senator Gaetz
       
       576-04250-16                                           2016212c2
    1                        A bill to be entitled                      
    2         An act relating to health care; creating s. 381.4019,
    3         F.S.; establishing a joint local and state dental care
    4         access account initiative, subject to the availability
    5         of funding; authorizing the creation of dental care
    6         access accounts; specifying the purpose of the
    7         initiative; defining terms; providing criteria for the
    8         selection of dentists for participation in the
    9         initiative; providing for the establishment of
   10         accounts; requiring the Department of Health to
   11         implement an electronic benefit transfer system;
   12         providing for the use of funds deposited in the
   13         accounts; requiring the department to distribute state
   14         funds to accounts, subject to legislative
   15         appropriations; authorizing the department to accept
   16         contributions from a local source for deposit in a
   17         designated account; limiting the number of years that
   18         an account may remain open; providing for the
   19         immediate closing of accounts under certain
   20         circumstances; authorizing the department to transfer
   21         state funds remaining in a closed account at a
   22         specified time and to return unspent funds from local
   23         sources; requiring a dentist to repay funds in certain
   24         circumstances; authorizing the department to pursue
   25         disciplinary enforcement actions and to use other
   26         legal means to recover funds; requiring the department
   27         to establish by rule application procedures and a
   28         process to verify the use of funds withdrawn from a
   29         dental care access account; requiring the department
   30         to give priority to applications from dentists
   31         practicing in certain areas; requiring the Department
   32         of Economic Opportunity to rank dental health
   33         professional shortage areas and medically underserved
   34         areas; requiring the Department of Health to develop a
   35         marketing plan in cooperation with certain dental
   36         colleges and the Florida Dental Association; requiring
   37         the Department of Health to annually submit a report
   38         with certain information to the Governor and the
   39         Legislature; providing rulemaking authority to require
   40         the submission of information for such reporting;
   41         amending s. 395.002, F.S.; revising the definition of
   42         the term “ambulatory surgical center” or “mobile
   43         surgical facility”; amending s. 395.003, F.S.;
   44         requiring, as a condition of licensure and license
   45         renewal, that ambulatory surgical centers provide
   46         services to specified patients in at least a specified
   47         amount; requiring ambulatory surgical centers to
   48         report certain data; defining a term; requiring
   49         ambulatory surgical centers to comply with certain
   50         building and lifesafety codes in certain
   51         circumstances; creating s. 624.27, F.S.; defining
   52         terms; specifying that a direct primary care agreement
   53         does not constitute insurance and is not subject to
   54         ch. 636, F.S., relating to prepaid limited health
   55         service organizations and discount medical plan
   56         organizations, or any other chapter of the Florida
   57         Insurance Code; specifying that entering into a direct
   58         primary care agreement does not constitute the
   59         business of insurance and is not subject to ch. 636,
   60         F.S., or any other chapter of the code; providing that
   61         certain certificates of authority and licenses are not
   62         required to market, sell, or offer to sell a direct
   63         primary care agreement; specifying requirements for a
   64         direct primary care agreement; providing a short
   65         title; amending s. 409.967, F.S.; requiring a managed
   66         care plan to establish a process by which a
   67         prescribing physician may request an override of
   68         certain restrictions in certain circumstances;
   69         providing the circumstances under which an override
   70         must be granted; defining the term “fail-first
   71         protocol”; creating s. 627.42392, F.S.; requiring an
   72         insurer to establish a process by which a prescribing
   73         physician may request an override of certain
   74         restrictions in certain circumstances; providing the
   75         circumstances under which an override must be granted;
   76         defining the term “fail-first protocol”; amending s.
   77         641.31, F.S.; prohibiting a health maintenance
   78         organization from requiring that a health care
   79         provider use a clinical decision support system or a
   80         laboratory benefits management program in certain
   81         circumstances; defining terms; providing for
   82         construction; creating s. 641.394, F.S.; requiring a
   83         health maintenance organization to establish a process
   84         by which a prescribing physician may request an
   85         override of certain restrictions in certain
   86         circumstances; providing the circumstances under which
   87         an override must be granted; defining the term “fail
   88         first protocol”; amending s. 766.1115, F.S.; revising
   89         the definitions of the terms “contract” and “health
   90         care provider”; deleting an obsolete date; extending
   91         sovereign immunity to employees or agents of a health
   92         care provider that executes a contract with a
   93         governmental contractor; clarifying that a receipt of
   94         specified notice must be acknowledged by a patient or
   95         the patient’s representative at the initial visit;
   96         requiring the posting of notice that a specified
   97         health care provider is an agent of a governmental
   98         contractor; amending s. 768.28, F.S.; revising the
   99         definition of the term “officer, employee, or agent”
  100         to include employees or agents of a health care
  101         provider as it applies to immunity from personal
  102         liability in certain actions; providing effective
  103         dates.
  104          
  105  Be It Enacted by the Legislature of the State of Florida:
  106  
  107         Section 1. Section 381.4019, Florida Statutes, is created
  108  to read:
  109         381.4019 Dental care access accounts.—Subject to the
  110  availability of funds, the Legislature establishes a joint local
  111  and state dental care access account initiative and authorizes
  112  the creation of dental care access accounts to promote economic
  113  development by supporting qualified dentists who practice in
  114  dental health professional shortage areas or medically
  115  underserved areas or who treat a medically underserved
  116  population. The Legislature recognizes that maintaining good
  117  oral health is integral to overall health status and that the
  118  good health of residents of this state is an important
  119  contributing factor in economic development. Better health,
  120  including better oral health, enables workers to be more
  121  productive, reduces the burden of health care costs, and enables
  122  children to improve in cognitive development.
  123         (1) As used in this section, the term:
  124         (a) “Dental health professional shortage area” means a
  125  geographic area so designated by the Health Resources and
  126  Services Administration of the United States Department of
  127  Health and Human Services.
  128         (b) “Department” means the Department of Health.
  129         (c) “Medically underserved area” means a geographic area so
  130  designated by the Health Resources and Services Administration
  131  of the United States Department of Health and Human Services.
  132         (d) “Public health program” means a county health
  133  department, the Children’s Medical Services Network, a federally
  134  qualified community health center, a federally funded migrant
  135  health center, or other publicly funded or nonprofit health care
  136  program as designated by the department.
  137         (2The department shall develop and implement a dental
  138  care access account initiative to benefit dentists licensed to
  139  practice in this state who demonstrate, as required by the
  140  department by rule:
  141         (a)Active employment by a public health program located in
  142  a dental health professional shortage area or a medically
  143  underserved area; or
  144         (b)A commitment to opening a private practice in a dental
  145  health professional shortage area or a medically underserved
  146  area, as demonstrated by the dentist residing in the designated
  147  area, maintaining an active Medicaid provider agreement,
  148  enrolling in one or more Medicaid managed care plans, expending
  149  sufficient capital to make substantial progress in opening a
  150  dental practice that is capable of serving at least 1,200
  151  patients, and obtaining financial support from the local
  152  community in which the dentist is practicing or intending to
  153  open a practice.
  154         (3) The department shall establish dental care access
  155  accounts as individual benefit accounts for each dentist who
  156  satisfies the requirements of subsection (2) and is selected by
  157  the department for participation. The department shall implement
  158  an electronic benefit transfer system that enables each dentist
  159  to spend funds from his or her account for the purposes
  160  described in subsection (4).
  161         (4Funds contributed from state and local sources to a
  162  dental care access account may be used for one or more of the
  163  following purposes:
  164         (a) Repayment of dental school student loans.
  165         (b) Investment in property, facilities, or equipment
  166  necessary to establish and operate a dental office consisting of
  167  no fewer than two operatories.
  168         (c) Payment of transitional expenses related to the
  169  relocation or opening of a dental practice which are
  170  specifically approved by the department.
  171         (5Subject to legislative appropriation, the department
  172  shall distribute state funds as an award to each dental care
  173  access account. An individual award must be in an amount not
  174  more than $100,000 and not less than $10,000, except that a
  175  state award may not exceed 3 times the amount contributed to an
  176  account in the same year from local sources. If a dentist
  177  qualifies for a dental care access account under paragraph
  178  (2)(a), the dentist’s salary and associated employer
  179  expenditures constitute a local match and qualify the account
  180  for a state award if the salary and associated expenditures do
  181  not come from state funds. State funds may not be included in a
  182  determination of the amount contributed to an account from local
  183  sources.
  184         (6) The department may accept contributions of funds from a
  185  local source for deposit in the account of a dentist designated
  186  by the donor.
  187         (7) The department shall close an account no later than 5
  188  years after the first deposit of state or local funds into that
  189  account or immediately upon the occurrence of any of the
  190  following:
  191         (a) Termination of the dentist’s employment with a public
  192  health program, unless, within 30 days after such termination,
  193  the dentist opens a private practice in a dental health
  194  professional shortage area or medically underserved area.
  195         (b) Termination of the dentist’s practice in a designated
  196  dental health professional shortage area or medically
  197  underserved area.
  198         (c) Termination of the dentist’s participation in the
  199  Florida Medicaid program.
  200         (d) Participation by the dentist in any fraudulent
  201  activity.
  202         (8) Any state funds remaining in a closed account may be
  203  awarded and transferred to another account concurrent with the
  204  distribution of funds under the next legislative appropriation
  205  for the initiative. The department shall return to the donor on
  206  a pro rata basis unspent funds from local sources which remain
  207  in a closed account.
  208         (9) If the department determines that a dentist has
  209  withdrawn account funds after the occurrence of an event
  210  specified in subsection (7), has used funds for purposes not
  211  authorized in subsection (4), or has not remained eligible for a
  212  dental care access account for a minimum of 2 years, the dentist
  213  shall repay the funds to his or her account. The department may
  214  recover the withdrawn funds through disciplinary enforcement
  215  actions and other methods authorized by law.
  216         (10) The department shall establish by rule:
  217         (a) Application procedures for dentists who wish to apply
  218  for a dental care access account. An applicant may demonstrate
  219  that he or she has expended sufficient capital to make
  220  substantial progress in opening a dental practice that is
  221  capable of serving at least 1,200 patients by documenting
  222  contracts for the purchase or lease of a practice location and
  223  providing executed obligations for the purchase or other
  224  acquisition of at least 30 percent of the value of equipment or
  225  supplies necessary to operate a dental practice. The department
  226  may limit the number of applicants selected and shall give
  227  priority to those applicants practicing in the areas receiving
  228  higher rankings pursuant to subsection (11). The department may
  229  establish additional criteria for selection which recognize an
  230  applicant’s active engagement with and commitment to the
  231  community providing a local match.
  232         (b)A process to verify that funds withdrawn from a dental
  233  care access account have been used solely for the purposes
  234  described in subsection (4).
  235         (11) The Department of Economic Opportunity shall rank the
  236  dental health professional shortage areas and medically
  237  underserved areas of the state based on the extent to which
  238  limited access to dental care is impeding the areas’ economic
  239  development, with a higher ranking indicating a greater
  240  impediment to development.
  241         (12) The department shall develop a marketing plan for the
  242  dental care access account initiative in cooperation with the
  243  University of Florida College of Dentistry, the Nova
  244  Southeastern University College of Dental Medicine, the Lake
  245  Erie College of Osteopathic Medicine School of Dental Medicine,
  246  and the Florida Dental Association.
  247         (13)(a) By January 1 of each year, beginning in 2018, the
  248  department shall issue a report to the Governor, the President
  249  of the Senate, and the Speaker of the House of Representatives
  250  which must include:
  251         1. The number of patients served by dentists receiving
  252  funding under this section.
  253         2. The number of Medicaid recipients served by dentists
  254  receiving funding under this section.
  255         3. The average number of hours worked and patients served
  256  in a week by dentists receiving funding under this section.
  257         4. The number of dentists in each dental health
  258  professional shortage area or medically underserved area
  259  receiving funding under this section.
  260         5. The amount and source of local matching funds received
  261  by the department.
  262         6. The amount of state funds awarded to dentists under this
  263  section.
  264         7. A complete accounting of the use of funds by categories
  265  identified by the department, including, but not limited to,
  266  loans, supplies, equipment, rental property payments, real
  267  property purchases, and salary and wages.
  268         (b) The department shall adopt rules to require dentists to
  269  report information to the department which is necessary for the
  270  department to fulfill its reporting requirement under this
  271  subsection.
  272         Section 2. Subsection (3) of section 395.002, Florida
  273  Statutes, is amended to read:
  274         395.002 Definitions.—As used in this chapter:
  275         (3) “Ambulatory surgical center” or “mobile surgical
  276  facility” means a facility the primary purpose of which is to
  277  provide elective surgical care, in which the patient is admitted
  278  to and discharged from such facility within 24 hours the same
  279  working day and is not permitted to stay overnight, and which is
  280  not part of a hospital. However, a facility existing for the
  281  primary purpose of performing terminations of pregnancy, an
  282  office maintained by a physician for the practice of medicine,
  283  or an office maintained for the practice of dentistry shall not
  284  be construed to be an ambulatory surgical center, provided that
  285  any facility or office which is certified or seeks certification
  286  as a Medicare ambulatory surgical center shall be licensed as an
  287  ambulatory surgical center pursuant to s. 395.003. Any structure
  288  or vehicle in which a physician maintains an office and
  289  practices surgery, and which can appear to the public to be a
  290  mobile office because the structure or vehicle operates at more
  291  than one address, shall be construed to be a mobile surgical
  292  facility.
  293         Section 3. Present subsections (6) through (10) of section
  294  395.003, Florida Statutes, are redesignated as subsections (7)
  295  through (11), respectively, a new subsection (6) is added to
  296  that section, and present subsections (9) and (10) of that
  297  section are amended, to read:
  298         395.003 Licensure; denial, suspension, and revocation.—
  299         (6) An ambulatory surgical center, as a condition of
  300  initial licensure and license renewal, must provide services to
  301  Medicare patients, Medicaid patients, and patients who qualify
  302  for charity care in an amount equal to or greater than the
  303  applicable district average among licensed providers of similar
  304  services. Ambulatory surgical centers shall report the same
  305  financial, patient, postoperative surgical infection, and other
  306  data pursuant to s. 408.061 as reported by hospitals to the
  307  Agency for Health Care Administration or otherwise published by
  308  the agency. For the purposes of this subsection, “charity care”
  309  means uncompensated care delivered to uninsured patients with
  310  incomes at or below 200 percent of the federal poverty level
  311  when such services are preauthorized by the licensee and not
  312  subject to collection procedures. An ambulatory surgical center
  313  that keeps patients later than midnight on the day of the
  314  procedure must comply with the same building codes and
  315  lifesafety codes as a hospital.
  316         (10)(9) A hospital licensed as of June 1, 2004, shall be
  317  exempt from subsection (9) subsection (8) as long as the
  318  hospital maintains the same ownership, facility street address,
  319  and range of services that were in existence on June 1, 2004.
  320  Any transfer of beds, or other agreements that result in the
  321  establishment of a hospital or hospital services within the
  322  intent of this section, shall be subject to subsection (9)
  323  subsection (8). Unless the hospital is otherwise exempt under
  324  subsection (9) subsection (8), the agency shall deny or revoke
  325  the license of a hospital that violates any of the criteria set
  326  forth in that subsection.
  327         (11)(10) The agency may adopt rules implementing the
  328  licensure requirements set forth in subsection (9) subsection
  329  (8). Within 14 days after rendering its decision on a license
  330  application or revocation, the agency shall publish its proposed
  331  decision in the Florida Administrative Register. Within 21 days
  332  after publication of the agency’s decision, any authorized
  333  person may file a request for an administrative hearing. In
  334  administrative proceedings challenging the approval, denial, or
  335  revocation of a license pursuant to subsection (9) subsection
  336  (8), the hearing must be based on the facts and law existing at
  337  the time of the agency’s proposed agency action. Existing
  338  hospitals may initiate or intervene in an administrative hearing
  339  to approve, deny, or revoke licensure under subsection (9)
  340  subsection (8) based upon a showing that an established program
  341  will be substantially affected by the issuance or renewal of a
  342  license to a hospital within the same district or service area.
  343         Section 4. Section 624.27, Florida Statutes, is created to
  344  read:
  345         624.27 Application of code as to direct primary care
  346  agreements.—
  347         (1) As used in this section, the term:
  348         (a) “Direct primary care agreement” means a contract
  349  between a primary care provider and a patient, the patient’s
  350  legal representative, or an employer which meets the
  351  requirements specified under subsection (4) and does not
  352  indemnify for services provided by a third party.
  353         (b) “Primary care provider” means a health care
  354  practitioner licensed under chapter 458, chapter 459, chapter
  355  460, or chapter 464, or a primary care group practice that
  356  provides medical services to patients which are commonly
  357  provided without referral from another health care provider.
  358         (c) “Primary care service” means the screening, assessment,
  359  diagnosis, and treatment of a patient for the purpose of
  360  promoting health or detecting and managing disease or injury
  361  within the competency and training of the primary care provider.
  362         (2) A direct primary care agreement does not constitute
  363  insurance and is not subject to chapter 636 or any other chapter
  364  of the Florida Insurance Code. The act of entering into a direct
  365  primary care agreement does not constitute the business of
  366  insurance and is not subject to chapter 636 or any other chapter
  367  of the Florida Insurance Code.
  368         (3) A primary care provider or an agent of a primary care
  369  provider is not required to obtain a certificate of authority or
  370  license under chapter 636 or any other chapter of the Florida
  371  Insurance Code to market, sell, or offer to sell a direct
  372  primary care agreement.
  373         (4) For purposes of this section, a direct primary care
  374  agreement must:
  375         (a) Be in writing.
  376         (b) Be signed by the primary care provider or an agent of
  377  the primary care provider and the patient, the patient’s legal
  378  representative, or an employer.
  379         (c) Allow a party to terminate the agreement by giving the
  380  other party at least 30 days’ advance written notice. The
  381  agreement may provide for immediate termination due to a
  382  violation of the physician-patient relationship or a breach of
  383  the terms of the agreement.
  384         (d) Describe the scope of primary care services that are
  385  covered by the monthly fee.
  386         (e) Specify the monthly fee and any fees for primary care
  387  services not covered by the monthly fee.
  388         (f) Specify the duration of the agreement and any automatic
  389  renewal provisions.
  390         (g) Offer a refund to the patient of monthly fees paid in
  391  advance if the primary care provider ceases to offer primary
  392  care services for any reason.
  393         (h) Contain in contrasting color and in not less than 12
  394  point type the following statements on the same page as the
  395  applicant’s signature:
  396         1. The agreement is not health insurance and the primary
  397  care provider will not file any claims against the patient’s
  398  health insurance policy or plan for reimbursement of any primary
  399  care services covered by the agreement.
  400         2. The agreement does not qualify as minimum essential
  401  coverage to satisfy the individual shared responsibility
  402  provision of the Patient Protection and Affordable Care Act, 26
  403  U.S.C. s. 5000A.
  404         Section 5. The sections created and amendments made by this
  405  act to ss. 409.967, 627.42392, 641.31, and 641.394, Florida
  406  Statutes, may be known as the “Right Medicine Right Time Act.”
  407         Section 6. Effective January 1, 2017, paragraph (c) of
  408  subsection (2) of section 409.967, Florida Statutes, is amended
  409  to read:
  410         409.967 Managed care plan accountability.—
  411         (2) The agency shall establish such contract requirements
  412  as are necessary for the operation of the statewide managed care
  413  program. In addition to any other provisions the agency may deem
  414  necessary, the contract must require:
  415         (c) Access.—
  416         1. The agency shall establish specific standards for the
  417  number, type, and regional distribution of providers in managed
  418  care plan networks to ensure access to care for both adults and
  419  children. Each plan must maintain a regionwide network of
  420  providers in sufficient numbers to meet the access standards for
  421  specific medical services for all recipients enrolled in the
  422  plan. The exclusive use of mail-order pharmacies may not be
  423  sufficient to meet network access standards. Consistent with the
  424  standards established by the agency, provider networks may
  425  include providers located outside the region. A plan may
  426  contract with a new hospital facility before the date the
  427  hospital becomes operational if the hospital has commenced
  428  construction, will be licensed and operational by January 1,
  429  2013, and a final order has issued in any civil or
  430  administrative challenge. Each plan shall establish and maintain
  431  an accurate and complete electronic database of contracted
  432  providers, including information about licensure or
  433  registration, locations and hours of operation, specialty
  434  credentials and other certifications, specific performance
  435  indicators, and such other information as the agency deems
  436  necessary. The database must be available online to both the
  437  agency and the public and have the capability to compare the
  438  availability of providers to network adequacy standards and to
  439  accept and display feedback from each provider’s patients. Each
  440  plan shall submit quarterly reports to the agency identifying
  441  the number of enrollees assigned to each primary care provider.
  442         2.a. Each managed care plan must publish any prescribed
  443  drug formulary or preferred drug list on the plan’s website in a
  444  manner that is accessible to and searchable by enrollees and
  445  providers. The plan must update the list within 24 hours after
  446  making a change. Each plan must ensure that the prior
  447  authorization process for prescribed drugs is readily accessible
  448  to health care providers, including posting appropriate contact
  449  information on its website and providing timely responses to
  450  providers. For Medicaid recipients diagnosed with hemophilia who
  451  have been prescribed anti-hemophilic-factor replacement
  452  products, the agency shall provide for those products and
  453  hemophilia overlay services through the agency’s hemophilia
  454  disease management program.
  455         b. If a managed care plan restricts the use of prescribed
  456  drugs through a fail-first protocol, it must establish a clear
  457  and convenient process that a prescribing physician may use to
  458  request an override of the restriction from the managed care
  459  plan. The managed care plan shall grant an override of the
  460  protocol within 24 hours if:
  461         (I) Based on sound clinical evidence, the prescribing
  462  provider concludes that the preferred treatment required under
  463  the fail-first protocol has been ineffective in the treatment of
  464  the enrollee’s disease or medical condition; or
  465         (II) Based on sound clinical evidence or medical and
  466  scientific evidence, the prescribing provider believes that the
  467  preferred treatment required under the fail-first protocol:
  468         (A) Is likely to be ineffective given the known relevant
  469  physical or mental characteristics and medical history of the
  470  enrollee and the known characteristics of the drug regimen; or
  471         (B) Will cause or is likely to cause an adverse reaction or
  472  other physical harm to the enrollee.
  473  
  474  If the prescribing provider follows the fail-first protocol
  475  recommended by the managed care plan for an enrollee, the
  476  duration of treatment under the fail-first protocol may not
  477  exceed a period deemed appropriate by the prescribing provider.
  478  Following such period, if the prescribing provider deems the
  479  treatment provided under the protocol clinically ineffective,
  480  the enrollee is entitled to receive the course of therapy that
  481  the prescribing provider recommends, and the provider is not
  482  required to seek approval of an override of the fail-first
  483  protocol. As used in this subparagraph, the term “fail-first
  484  protocol” means a prescription practice that begins medication
  485  for a medical condition with the most cost-effective drug
  486  therapy and progresses to other more costly or risky therapies
  487  only if necessary.
  488         3. Managed care plans, and their fiscal agents or
  489  intermediaries, must accept prior authorization requests for any
  490  service electronically.
  491         4. Managed care plans serving children in the care and
  492  custody of the Department of Children and Families shall must
  493  maintain complete medical, dental, and behavioral health
  494  encounter information and participate in making such information
  495  available to the department or the applicable contracted
  496  community-based care lead agency for use in providing
  497  comprehensive and coordinated case management. The agency and
  498  the department shall establish an interagency agreement to
  499  provide guidance for the format, confidentiality, recipient,
  500  scope, and method of information to be made available and the
  501  deadlines for submission of the data. The scope of information
  502  available to the department are shall be the data that managed
  503  care plans are required to submit to the agency. The agency
  504  shall determine the plan’s compliance with standards for access
  505  to medical, dental, and behavioral health services; the use of
  506  medications; and followup on all medically necessary services
  507  recommended as a result of early and periodic screening,
  508  diagnosis, and treatment.
  509         Section 7. Effective January 1, 2017, section 627.42392,
  510  Florida Statutes, is created to read:
  511         627.42392Fail-first protocols.—If an insurer restricts the
  512  use of prescribed drugs through a fail-first protocol, it must
  513  establish a clear and convenient process that a prescribing
  514  physician may use to request an override of the restriction from
  515  the insurer. The insurer shall grant an override of the protocol
  516  within 24 hours if:
  517         (1) Based on sound clinical evidence, the prescribing
  518  provider concludes that the preferred treatment required under
  519  the fail-first protocol has been ineffective in the treatment of
  520  the insured’s disease or medical condition; or
  521         (2) Based on sound clinical evidence or medical and
  522  scientific evidence, the prescribing provider believes that the
  523  preferred treatment required under the fail-first protocol:
  524         (a) Is likely to be ineffective given the known relevant
  525  physical or mental characteristics and medical history of the
  526  insured and the known characteristics of the drug regimen; or
  527         (b) Will cause or is likely to cause an adverse reaction or
  528  other physical harm to the insured.
  529  
  530  If the prescribing provider follows the fail-first protocol
  531  recommended by the insurer for an insured, the duration of
  532  treatment under the fail-first protocol may not exceed a period
  533  deemed appropriate by the prescribing provider. Following such
  534  period, if the prescribing provider deems the treatment provided
  535  under the protocol clinically ineffective, the insured is
  536  entitled to receive the course of therapy that the prescribing
  537  provider recommends, and the provider is not required to seek
  538  approval of an override of the fail-first protocol. As used in
  539  this section, the term “fail-first protocol” means a
  540  prescription practice that begins medication for a medical
  541  condition with the most cost-effective drug therapy and
  542  progresses to other more costly or risky therapies only if
  543  necessary.
  544         Section 8. Effective January 1, 2017, subsection (44) is
  545  added to section 641.31, Florida Statutes, to read:
  546         641.31 Health maintenance contracts.—
  547         (44) A health maintenance organization may not require a
  548  health care provider, by contract with another health care
  549  provider, a patient, or another individual or entity, to use a
  550  clinical decision support system or a laboratory benefits
  551  management program before the provider may order clinical
  552  laboratory services or in an attempt to direct or limit the
  553  provider’s medical decisionmaking relating to the use of such
  554  services. This subsection may not be construed to prohibit any
  555  prior authorization requirements that the health maintenance
  556  organization may have regarding the provision of clinical
  557  laboratory services. As used in this subsection, the term:
  558         (a) “Clinical decision support system” means software
  559  designed to direct or assist clinical decisionmaking by matching
  560  the characteristics of an individual patient to a computerized
  561  clinical knowledge base and providing patient-specific
  562  assessments or recommendations based on the match.
  563         (b) “Clinical laboratory services” means the examination of
  564  fluids or other materials taken from the human body, which
  565  examination is ordered by a health care provider for use in the
  566  diagnosis, prevention, or treatment of a disease or in the
  567  identification or assessment of a medical or physical condition.
  568         (c) “Laboratory benefits management program” means a health
  569  maintenance organization protocol that dictates or limits health
  570  care provider decisionmaking relating to the use of clinical
  571  laboratory services.
  572         Section 9. Effective January 1, 2017, section 641.394,
  573  Florida Statutes, is created to read:
  574         641.394 Fail-first protocols.—If a health maintenance
  575  organization restricts the use of prescribed drugs through a
  576  fail-first protocol, it must establish a clear and convenient
  577  process that a prescribing physician may use to request an
  578  override of the restriction from the health maintenance
  579  organization. The health maintenance organization shall grant an
  580  override of the protocol within 24 hours if:
  581         (1) Based on sound clinical evidence, the prescribing
  582  provider concludes that the preferred treatment required under
  583  the fail-first protocol has been ineffective in the treatment of
  584  the subscriber’s disease or medical condition; or
  585         (2) Based on sound clinical evidence or medical and
  586  scientific evidence, the prescribing provider believes that the
  587  preferred treatment required under the fail-first protocol:
  588         (a) Is likely to be ineffective given the known relevant
  589  physical or mental characteristics and medical history of the
  590  subscriber and the known characteristics of the drug regimen; or
  591         (b) Will cause or is likely to cause an adverse reaction or
  592  other physical harm to the subscriber.
  593  
  594  If the prescribing provider follows the fail-first protocol
  595  recommended by the health maintenance organization for a
  596  subscriber, the duration of treatment under the fail-first
  597  protocol may not exceed a period deemed appropriate by the
  598  prescribing provider. Following such period, if the prescribing
  599  provider deems the treatment provided under the protocol
  600  clinically ineffective, the subscriber is entitled to receive
  601  the course of therapy that the prescribing provider recommends,
  602  and the provider is not required to seek approval of an override
  603  of the fail-first protocol. As used in this section, the term
  604  “fail-first protocol” means a prescription practice that begins
  605  medication for a medical condition with the most cost-effective
  606  drug therapy and progresses to other more costly or risky
  607  therapies only if necessary.
  608         Section 10. Paragraphs (a) and (d) of subsection (3) and
  609  subsections (4) and (5) of section 766.1115, Florida Statutes,
  610  are amended to read:
  611         766.1115 Health care providers; creation of agency
  612  relationship with governmental contractors.—
  613         (3) DEFINITIONS.—As used in this section, the term:
  614         (a) “Contract” means an agreement executed in compliance
  615  with this section between a health care provider and a
  616  governmental contractor for volunteer, uncompensated services
  617  which allows the health care provider to deliver health care
  618  services to low-income recipients as an agent of the
  619  governmental contractor. The contract must be for volunteer,
  620  uncompensated services, except as provided in paragraph (4)(g).
  621  For services to qualify as volunteer, uncompensated services
  622  under this section, the health care provider, or any employee or
  623  agent of the health care provider, must receive no compensation
  624  from the governmental contractor for any services provided under
  625  the contract and must not bill or accept compensation from the
  626  recipient, or a public or private third-party payor, for the
  627  specific services provided to the low-income recipients covered
  628  by the contract, except as provided in paragraph (4)(g). A free
  629  clinic as described in subparagraph (d)14. may receive a
  630  legislative appropriation, a grant through a legislative
  631  appropriation, or a grant from a governmental entity or
  632  nonprofit corporation to support the delivery of contracted
  633  services by volunteer health care providers, including the
  634  employment of health care providers to supplement, coordinate,
  635  or support the delivery of such services. The appropriation or
  636  grant for the free clinic does not constitute compensation under
  637  this paragraph from the governmental contractor for services
  638  provided under the contract, nor does receipt or use of the
  639  appropriation or grant constitute the acceptance of compensation
  640  under this paragraph for the specific services provided to the
  641  low-income recipients covered by the contract.
  642         (d) “Health care provider” or “provider” means:
  643         1. A birth center licensed under chapter 383.
  644         2. An ambulatory surgical center licensed under chapter
  645  395.
  646         3. A hospital licensed under chapter 395.
  647         4. A physician or physician assistant licensed under
  648  chapter 458.
  649         5. An osteopathic physician or osteopathic physician
  650  assistant licensed under chapter 459.
  651         6. A chiropractic physician licensed under chapter 460.
  652         7. A podiatric physician licensed under chapter 461.
  653         8. A registered nurse, nurse midwife, licensed practical
  654  nurse, or advanced registered nurse practitioner licensed or
  655  registered under part I of chapter 464 or any facility which
  656  employs nurses licensed or registered under part I of chapter
  657  464 to supply all or part of the care delivered under this
  658  section.
  659         9. A midwife licensed under chapter 467.
  660         10. A health maintenance organization certificated under
  661  part I of chapter 641.
  662         11. A health care professional association and its
  663  employees or a corporate medical group and its employees.
  664         12. Any other medical facility the primary purpose of which
  665  is to deliver human medical diagnostic services or which
  666  delivers nonsurgical human medical treatment, and which includes
  667  an office maintained by a provider.
  668         13. A dentist or dental hygienist licensed under chapter
  669  466.
  670         14. A free clinic that delivers only medical diagnostic
  671  services or nonsurgical medical treatment free of charge to all
  672  low-income recipients.
  673         15. A pharmacy or pharmacist licensed under chapter 465.
  674         16.15. Any other health care professional, practitioner,
  675  provider, or facility under contract with a governmental
  676  contractor, including a student enrolled in an accredited
  677  program that prepares the student for licensure as any one of
  678  the professionals listed in subparagraphs 4.-9.
  679  
  680  The term includes any nonprofit corporation qualified as exempt
  681  from federal income taxation under s. 501(a) of the Internal
  682  Revenue Code, and described in s. 501(c) of the Internal Revenue
  683  Code, which delivers health care services provided by licensed
  684  professionals listed in this paragraph, any federally funded
  685  community health center, and any volunteer corporation or
  686  volunteer health care provider that delivers health care
  687  services.
  688         (4) CONTRACT REQUIREMENTS.—A health care provider that
  689  executes a contract with a governmental contractor to deliver
  690  health care services on or after April 17, 1992, as an agent of
  691  the governmental contractor, or any employee or agent of such
  692  health care provider, is an agent for purposes of s. 768.28(9),
  693  while acting within the scope of duties under the contract, if
  694  the contract complies with the requirements of this section and
  695  regardless of whether the individual treated is later found to
  696  be ineligible. A health care provider, or any employee or agent
  697  of such health care provider, shall continue to be an agent for
  698  purposes of s. 768.28(9) for 30 days after a determination of
  699  ineligibility to allow for treatment until the individual
  700  transitions to treatment by another health care provider. A
  701  health care provider, or any employee or agent of such health
  702  care provider, under contract with the state may not be named as
  703  a defendant in any action arising out of medical care or
  704  treatment provided on or after April 17, 1992, under contracts
  705  entered into under this section. The contract must provide that:
  706         (a) The right of dismissal or termination of any health
  707  care provider delivering services under the contract is retained
  708  by the governmental contractor.
  709         (b) The governmental contractor has access to the patient
  710  records of any health care provider delivering services under
  711  the contract.
  712         (c) Adverse incidents and information on treatment outcomes
  713  must be reported by any health care provider to the governmental
  714  contractor if the incidents and information pertain to a patient
  715  treated under the contract. The health care provider shall
  716  submit the reports required by s. 395.0197. If an incident
  717  involves a professional licensed by the Department of Health or
  718  a facility licensed by the Agency for Health Care
  719  Administration, the governmental contractor shall submit such
  720  incident reports to the appropriate department or agency, which
  721  shall review each incident and determine whether it involves
  722  conduct by the licensee that is subject to disciplinary action.
  723  All patient medical records and any identifying information
  724  contained in adverse incident reports and treatment outcomes
  725  which are obtained by governmental entities under this paragraph
  726  are confidential and exempt from the provisions of s. 119.07(1)
  727  and s. 24(a), Art. I of the State Constitution.
  728         (d) Patient selection and initial referral must be made by
  729  the governmental contractor or the provider. Patients may not be
  730  transferred to the provider based on a violation of the
  731  antidumping provisions of the Omnibus Budget Reconciliation Act
  732  of 1989, the Omnibus Budget Reconciliation Act of 1990, or
  733  chapter 395.
  734         (e) If emergency care is required, the patient need not be
  735  referred before receiving treatment, but must be referred within
  736  48 hours after treatment is commenced or within 48 hours after
  737  the patient has the mental capacity to consent to treatment,
  738  whichever occurs later.
  739         (f) The provider is subject to supervision and regular
  740  inspection by the governmental contractor.
  741         (g) As an agent of the governmental contractor for purposes
  742  of s. 768.28(9), while acting within the scope of duties under
  743  the contract, A health care provider licensed under chapter 466,
  744  as an agent of the governmental contractor for purposes of s.
  745  768.28(9), may allow a patient, or a parent or guardian of the
  746  patient, to voluntarily contribute a monetary amount to cover
  747  costs of dental laboratory work related to the services provided
  748  to the patient within the scope of duties under the contract.
  749  This contribution may not exceed the actual cost of the dental
  750  laboratory charges.
  751  
  752  A governmental contractor that is also a health care provider is
  753  not required to enter into a contract under this section with
  754  respect to the health care services delivered by its employees.
  755         (5) NOTICE OF AGENCY RELATIONSHIP.—The governmental
  756  contractor must provide written notice to each patient, or the
  757  patient’s legal representative, receipt of which must be
  758  acknowledged in writing at the initial visit, that the provider
  759  is an agent of the governmental contractor and that the
  760  exclusive remedy for injury or damage suffered as the result of
  761  any act or omission of the provider or of any employee or agent
  762  thereof acting within the scope of duties pursuant to the
  763  contract is by commencement of an action pursuant to the
  764  provisions of s. 768.28. Thereafter, or with respect to any
  765  federally funded community health center, the notice
  766  requirements may be met by posting in a place conspicuous to all
  767  persons a notice that the health care provider, or federally
  768  funded community health center, is an agent of the governmental
  769  contractor and that the exclusive remedy for injury or damage
  770  suffered as the result of any act or omission of the provider or
  771  of any employee or agent thereof acting within the scope of
  772  duties pursuant to the contract is by commencement of an action
  773  pursuant to the provisions of s. 768.28.
  774         Section 11. Paragraphs (a) and (b) of subsection (9) of
  775  section 768.28, Florida Statutes, are amended to read:
  776         768.28 Waiver of sovereign immunity in tort actions;
  777  recovery limits; limitation on attorney fees; statute of
  778  limitations; exclusions; indemnification; risk management
  779  programs.—
  780         (9)(a) An No officer, employee, or agent of the state or of
  781  any of its subdivisions may not shall be held personally liable
  782  in tort or named as a party defendant in any action for any
  783  injury or damage suffered as a result of any act, event, or
  784  omission of action in the scope of her or his employment or
  785  function, unless such officer, employee, or agent acted in bad
  786  faith or with malicious purpose or in a manner exhibiting wanton
  787  and willful disregard of human rights, safety, or property.
  788  However, such officer, employee, or agent shall be considered an
  789  adverse witness in a tort action for any injury or damage
  790  suffered as a result of any act, event, or omission of action in
  791  the scope of her or his employment or function. The exclusive
  792  remedy for injury or damage suffered as a result of an act,
  793  event, or omission of an officer, employee, or agent of the
  794  state or any of its subdivisions or constitutional officers is
  795  shall be by action against the governmental entity, or the head
  796  of such entity in her or his official capacity, or the
  797  constitutional officer of which the officer, employee, or agent
  798  is an employee, unless such act or omission was committed in bad
  799  faith or with malicious purpose or in a manner exhibiting wanton
  800  and willful disregard of human rights, safety, or property. The
  801  state or its subdivisions are shall not be liable in tort for
  802  the acts or omissions of an officer, employee, or agent
  803  committed while acting outside the course and scope of her or
  804  his employment or committed in bad faith or with malicious
  805  purpose or in a manner exhibiting wanton and willful disregard
  806  of human rights, safety, or property.
  807         (b) As used in this subsection, the term:
  808         1. “Employee” includes any volunteer firefighter.
  809         2. “Officer, employee, or agent” includes, but is not
  810  limited to, any health care provider, and its employees or
  811  agents, when providing services pursuant to s. 766.1115; any
  812  nonprofit independent college or university located and
  813  chartered in this state which owns or operates an accredited
  814  medical school, and its employees or agents, when providing
  815  patient services pursuant to paragraph (10)(f); and any public
  816  defender or her or his employee or agent, including, among
  817  others, an assistant public defender or and an investigator.
  818         Section 12. Except as otherwise expressly provided in this
  819  act, this act shall take effect July 1, 2016.