Florida Senate - 2016                          SENATOR AMENDMENT
       Bill No. HB 85
       
       
       
       
       
       
                                Ì185754BÎ185754                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/AE/2R         .        Floor: SENAT/RC         
             03/09/2016 07:30 PM       .      03/11/2016 10:25 AM       
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       Senator Gaetz moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 381.4019, Florida Statutes, is created
    6  to read:
    7         381.4019 Dental care access accounts.—Subject to the
    8  availability of funds, the Legislature establishes a joint local
    9  and state dental care access account initiative and authorizes
   10  the creation of dental care access accounts to promote economic
   11  development by supporting qualified dentists who practice in
   12  dental health professional shortage areas or medically
   13  underserved areas or who treat a medically underserved
   14  population. The Legislature recognizes that maintaining good
   15  oral health is integral to overall health status and that the
   16  good health of residents of this state is an important
   17  contributing factor in economic development. Better health,
   18  including better oral health, enables workers to be more
   19  productive, reduces the burden of health care costs, and enables
   20  children to improve in cognitive development.
   21         (1) As used in this section, the term:
   22         (a) “Dental health professional shortage area” means a
   23  geographic area so designated by the Health Resources and
   24  Services Administration of the United States Department of
   25  Health and Human Services.
   26         (b) “Department” means the Department of Health.
   27         (c) “Medically underserved area” means a geographic area so
   28  designated by the Health Resources and Services Administration
   29  of the United States Department of Health and Human Services.
   30         (d) “Public health program” means a county health
   31  department, the Children’s Medical Services Network, a federally
   32  qualified community health center, a federally funded migrant
   33  health center, or other publicly funded or nonprofit health care
   34  program as designated by the department.
   35         (2The department shall develop and implement a dental
   36  care access account initiative to benefit dentists licensed to
   37  practice in this state who demonstrate, as required by the
   38  department by rule:
   39         (a)Active employment by a public health program located in
   40  a dental health professional shortage area or a medically
   41  underserved area; or
   42         (b)A commitment to opening a private practice in a dental
   43  health professional shortage area or a medically underserved
   44  area, as demonstrated by the dentist residing in the designated
   45  area, maintaining an active Medicaid provider agreement,
   46  enrolling in one or more Medicaid managed care plans, expending
   47  sufficient capital to make substantial progress in opening a
   48  dental practice that is capable of serving at least 1,200
   49  patients, and obtaining financial support from the local
   50  community in which the dentist is practicing or intending to
   51  open a practice.
   52         (3) The department shall establish dental care access
   53  accounts as individual benefit accounts for each dentist who
   54  satisfies the requirements of subsection (2) and is selected by
   55  the department for participation. The department shall implement
   56  an electronic benefit transfer system that enables each dentist
   57  to spend funds from his or her account for the purposes
   58  described in subsection (4).
   59         (4Funds contributed from state and local sources to a
   60  dental care access account may be used for one or more of the
   61  following purposes:
   62         (a) Repayment of dental school student loans.
   63         (b) Investment in property, facilities, or equipment
   64  necessary to establish and operate a dental office consisting of
   65  no fewer than two operatories.
   66         (c) Payment of transitional expenses related to the
   67  relocation or opening of a dental practice which are
   68  specifically approved by the department.
   69         (5Subject to legislative appropriation, the department
   70  shall distribute state funds as an award to each dental care
   71  access account. An individual award must be in an amount not
   72  more than $100,000 and not less than $10,000, except that a
   73  state award may not exceed 3 times the amount contributed to an
   74  account in the same year from local sources. If a dentist
   75  qualifies for a dental care access account under paragraph
   76  (2)(a), the dentist’s salary and associated employer
   77  expenditures constitute a local match and qualify the account
   78  for a state award if the salary and associated expenditures do
   79  not come from state funds. State funds may not be included in a
   80  determination of the amount contributed to an account from local
   81  sources.
   82         (6) The department may accept contributions of funds from a
   83  local source for deposit in the account of a dentist designated
   84  by the donor.
   85         (7) The department shall close an account no later than 5
   86  years after the first deposit of state or local funds into that
   87  account or immediately upon the occurrence of any of the
   88  following:
   89         (a) Termination of the dentist’s employment with a public
   90  health program, unless, within 30 days after such termination,
   91  the dentist opens a private practice in a dental health
   92  professional shortage area or medically underserved area.
   93         (b) Termination of the dentist’s practice in a designated
   94  dental health professional shortage area or medically
   95  underserved area.
   96         (c) Termination of the dentist’s participation in the
   97  Florida Medicaid program.
   98         (d) Participation by the dentist in any fraudulent
   99  activity.
  100         (8) Any state funds remaining in a closed account may be
  101  awarded and transferred to another account concurrent with the
  102  distribution of funds under the next legislative appropriation
  103  for the initiative. The department shall return to the donor on
  104  a pro rata basis unspent funds from local sources which remain
  105  in a closed account.
  106         (9) If the department determines that a dentist has
  107  withdrawn account funds after the occurrence of an event
  108  specified in subsection (7), has used funds for purposes not
  109  authorized in subsection (4), or has not remained eligible for a
  110  dental care access account for a minimum of 2 years, the dentist
  111  shall repay the funds to his or her account. The department may
  112  recover the withdrawn funds through disciplinary enforcement
  113  actions and other methods authorized by law.
  114         (10) The department shall establish by rule:
  115         (a) Application procedures for dentists who wish to apply
  116  for a dental care access account. An applicant may demonstrate
  117  that he or she has expended sufficient capital to make
  118  substantial progress in opening a dental practice that is
  119  capable of serving at least 1,200 patients by documenting
  120  contracts for the purchase or lease of a practice location and
  121  providing executed obligations for the purchase or other
  122  acquisition of at least 30 percent of the value of equipment or
  123  supplies necessary to operate a dental practice. The department
  124  may limit the number of applicants selected and shall give
  125  priority to those applicants practicing in the areas receiving
  126  higher rankings pursuant to subsection (11). The department may
  127  establish additional criteria for selection which recognize an
  128  applicant’s active engagement with and commitment to the
  129  community providing a local match.
  130         (b)A process to verify that funds withdrawn from a dental
  131  care access account have been used solely for the purposes
  132  described in subsection (4).
  133         (11) The Department of Economic Opportunity shall rank the
  134  dental health professional shortage areas and medically
  135  underserved areas of the state based on the extent to which
  136  limited access to dental care is impeding the areas’ economic
  137  development, with a higher ranking indicating a greater
  138  impediment to development.
  139         (12) The department shall develop a marketing plan for the
  140  dental care access account initiative in cooperation with the
  141  University of Florida College of Dentistry, the Nova
  142  Southeastern University College of Dental Medicine, the Lake
  143  Erie College of Osteopathic Medicine School of Dental Medicine,
  144  and the Florida Dental Association.
  145         (13)(a) By January 1 of each year, beginning in 2018, the
  146  department shall issue a report to the Governor, the President
  147  of the Senate, and the Speaker of the House of Representatives
  148  which must include:
  149         1. The number of patients served by dentists receiving
  150  funding under this section.
  151         2. The number of Medicaid recipients served by dentists
  152  receiving funding under this section.
  153         3. The average number of hours worked and patients served
  154  in a week by dentists receiving funding under this section.
  155         4. The number of dentists in each dental health
  156  professional shortage area or medically underserved area
  157  receiving funding under this section.
  158         5. The amount and source of local matching funds received
  159  by the department.
  160         6. The amount of state funds awarded to dentists under this
  161  section.
  162         7. A complete accounting of the use of funds by categories
  163  identified by the department, including, but not limited to,
  164  loans, supplies, equipment, rental property payments, real
  165  property purchases, and salary and wages.
  166         (b) The department shall adopt rules to require dentists to
  167  report information to the department which is necessary for the
  168  department to fulfill its reporting requirement under this
  169  subsection.
  170         Section 2. Subsection (3) of section 395.002, Florida
  171  Statutes, is amended to read:
  172         395.002 Definitions.—As used in this chapter:
  173         (3) “Ambulatory surgical center” or “mobile surgical
  174  facility” means a facility the primary purpose of which is to
  175  provide elective surgical care, in which the patient is admitted
  176  to and discharged from such facility within 24 hours the same
  177  working day and is not permitted to stay overnight, and which is
  178  not part of a hospital. However, a facility existing for the
  179  primary purpose of performing terminations of pregnancy, an
  180  office maintained by a physician for the practice of medicine,
  181  or an office maintained for the practice of dentistry shall not
  182  be construed to be an ambulatory surgical center, provided that
  183  any facility or office which is certified or seeks certification
  184  as a Medicare ambulatory surgical center shall be licensed as an
  185  ambulatory surgical center pursuant to s. 395.003. Any structure
  186  or vehicle in which a physician maintains an office and
  187  practices surgery, and which can appear to the public to be a
  188  mobile office because the structure or vehicle operates at more
  189  than one address, shall be construed to be a mobile surgical
  190  facility.
  191         Section 3. Present subsections (6) through (10) of section
  192  395.003, Florida Statutes, are redesignated as subsections (7)
  193  through (11), respectively, a new subsection (6) is added to
  194  that section, and present subsections (9) and (10) of that
  195  section are amended, to read:
  196         395.003 Licensure; denial, suspension, and revocation.—
  197         (6) An ambulatory surgical center, as a condition of
  198  initial licensure and license renewal, must provide services to
  199  Medicare patients, Medicaid patients, and patients who qualify
  200  for charity care in an amount equal to or greater than the
  201  applicable district average among licensed providers of similar
  202  services. Ambulatory surgical centers shall report the same
  203  financial, patient, postoperative surgical infection, and other
  204  data pursuant to s. 408.061 as reported by hospitals to the
  205  Agency for Health Care Administration or otherwise published by
  206  the agency. For the purposes of this subsection, “charity care”
  207  means uncompensated care delivered to uninsured patients with
  208  incomes at or below 200 percent of the federal poverty level
  209  when such services are preauthorized by the licensee and not
  210  subject to collection procedures. An ambulatory surgical center
  211  that keeps patients later than midnight on the day of the
  212  procedure must comply with the same building codes and
  213  lifesafety codes as a hospital.
  214         (10)(9) A hospital licensed as of June 1, 2004, shall be
  215  exempt from subsection (9) subsection (8) as long as the
  216  hospital maintains the same ownership, facility street address,
  217  and range of services that were in existence on June 1, 2004.
  218  Any transfer of beds, or other agreements that result in the
  219  establishment of a hospital or hospital services within the
  220  intent of this section, shall be subject to subsection (9)
  221  subsection (8). Unless the hospital is otherwise exempt under
  222  subsection (9) subsection (8), the agency shall deny or revoke
  223  the license of a hospital that violates any of the criteria set
  224  forth in that subsection.
  225         (11)(10) The agency may adopt rules implementing the
  226  licensure requirements set forth in subsection (9) subsection
  227  (8). Within 14 days after rendering its decision on a license
  228  application or revocation, the agency shall publish its proposed
  229  decision in the Florida Administrative Register. Within 21 days
  230  after publication of the agency’s decision, any authorized
  231  person may file a request for an administrative hearing. In
  232  administrative proceedings challenging the approval, denial, or
  233  revocation of a license pursuant to subsection (9) subsection
  234  (8), the hearing must be based on the facts and law existing at
  235  the time of the agency’s proposed agency action. Existing
  236  hospitals may initiate or intervene in an administrative hearing
  237  to approve, deny, or revoke licensure under subsection (9)
  238  subsection (8) based upon a showing that an established program
  239  will be substantially affected by the issuance or renewal of a
  240  license to a hospital within the same district or service area.
  241         Section 4. Present subsections (1) through (10) of section
  242  395.0191, Florida Statutes, are redesignated as subsections (2)
  243  through (11), respectively, a new subsection (1) and subsection
  244  (12) are added to that section, and present subsection (6) of
  245  that section is amended, to read:
  246         395.0191 Staff membership and clinical privileges.—
  247         (1) As used in this section, the term:
  248         (a) “Certified surgical assistant” means a surgical
  249  assistant who maintains a valid and active certification under
  250  one of the following designations: certified surgical first
  251  assistant, from the National Board of Surgical Technology and
  252  Surgical Assisting; certified surgical assistant, from the
  253  National Surgical Assistant Association; or surgical assistant
  254  certified, from the American Board of Surgical Assistants.
  255         (b) “Certified surgical technologist” means a surgical
  256  technologist who maintains a valid and active certification as a
  257  certified surgical technologist from the National Board of
  258  Surgical Technology and Surgical Assisting.
  259         (c) “Surgeon” means a health care practitioner as defined
  260  in s. 456.001 whose scope of practice includes performing
  261  surgery and who is listed as the primary surgeon in the
  262  operative record.
  263         (d) “Surgical assistant” means a person who provides aid in
  264  exposure, hemostasis, closures, and other intraoperative
  265  technical functions and who assists the surgeon in performing a
  266  safe operation with optimal results for the patient.
  267         (e) “Surgical technologist” means a person whose duties
  268  include, but are not limited to, maintaining sterility during a
  269  surgical procedure, handling and ensuring the availability of
  270  necessary equipment and supplies, and maintaining visibility of
  271  the operative site to ensure that the operating room environment
  272  is safe, that proper equipment is available, and that the
  273  operative procedure is conducted efficiently.
  274         (7)(6) Upon the written request of the applicant, any
  275  licensed facility that has denied staff membership or clinical
  276  privileges to any applicant specified in subsection (1) or
  277  subsection (2) or subsection (3) shall, within 30 days of such
  278  request, provide the applicant with the reasons for such denial
  279  in writing. A denial of staff membership or clinical privileges
  280  to any applicant shall be submitted, in writing, to the
  281  applicant’s respective licensing board.
  282         (12) At least 50 percent of the surgical assistants and 50
  283  percent of the surgical technologists that a licensed facility
  284  employs or with whom it contracts must be certified surgical
  285  assistants and certified surgical technologists, respectively.
  286  The requirements of this subsection do not apply to the
  287  following:
  288         (a) A person who has completed an appropriate training
  289  program for surgical technology in any branch of the Armed
  290  Forces or reserve component of the Armed Forces.
  291         (b) A person who was employed or contracted to perform the
  292  duties of a surgical technologist or surgical assistant at any
  293  time before July 1, 2016.
  294         (c) A health care practitioner as defined in s. 456.001 or
  295  a student if the duties performed by the practitioner or the
  296  student are within the scope of the practitioner’s or the
  297  student’s training and practice.
  298         (d) A person enrolled in a surgical technology or surgical
  299  assisting training program accredited by the Commission on
  300  Accreditation of Allied Health Education Programs, the
  301  Accrediting Bureau of Health Education Schools, or another
  302  accrediting body recognized by the United States Department of
  303  Education on July 1, 2016. A person may practice as a surgical
  304  technologist or a surgical assistant for 2 years after
  305  completion of such a training program before he or she is
  306  required to obtain a certification under this subsection.
  307         Section 5. Section 624.27, Florida Statutes, is created to
  308  read:
  309         624.27 Application of code as to direct primary care
  310  agreements.—
  311         (1) As used in this section, the term:
  312         (a) “Direct primary care agreement” means a contract
  313  between a primary care provider and a patient, the patient’s
  314  legal representative, or an employer which meets the
  315  requirements specified under subsection (4) and does not
  316  indemnify for services provided by a third party.
  317         (b) “Primary care provider” means a health care
  318  practitioner licensed under chapter 458, chapter 459, chapter
  319  460, or chapter 464, or a primary care group practice that
  320  provides medical services to patients which are commonly
  321  provided without referral from another health care provider.
  322         (c) “Primary care service” means the screening, assessment,
  323  diagnosis, and treatment of a patient for the purpose of
  324  promoting health or detecting and managing disease or injury
  325  within the competency and training of the primary care provider.
  326         (2) A direct primary care agreement does not constitute
  327  insurance and is not subject to chapter 636 or any other chapter
  328  of the Florida Insurance Code. The act of entering into a direct
  329  primary care agreement does not constitute the business of
  330  insurance and is not subject to chapter 636 or any other chapter
  331  of the Florida Insurance Code.
  332         (3) A primary care provider or an agent of a primary care
  333  provider is not required to obtain a certificate of authority or
  334  license under chapter 636 or any other chapter of the Florida
  335  Insurance Code to market, sell, or offer to sell a direct
  336  primary care agreement.
  337         (4) For purposes of this section, a direct primary care
  338  agreement must:
  339         (a) Be in writing.
  340         (b) Be signed by the primary care provider or an agent of
  341  the primary care provider and the patient, the patient’s legal
  342  representative, or an employer.
  343         (c) Allow a party to terminate the agreement by giving the
  344  other party at least 30 days’ advance written notice. The
  345  agreement may provide for immediate termination due to a
  346  violation of the physician-patient relationship or a breach of
  347  the terms of the agreement.
  348         (d) Describe the scope of primary care services that are
  349  covered by the monthly fee.
  350         (e) Specify the monthly fee and any fees for primary care
  351  services not covered by the monthly fee.
  352         (f) Specify the duration of the agreement and any automatic
  353  renewal provisions.
  354         (g) Offer a refund to the patient of monthly fees paid in
  355  advance if the primary care provider ceases to offer primary
  356  care services for any reason.
  357         (h) Contain in contrasting color and in not less than 12
  358  point type the following statements on the same page as the
  359  applicant’s signature:
  360         1. The agreement is not health insurance and the primary
  361  care provider will not file any claims against the patient’s
  362  health insurance policy or plan for reimbursement of any primary
  363  care services covered by the agreement.
  364         2. The agreement does not qualify as minimum essential
  365  coverage to satisfy the individual shared responsibility
  366  provision of the Patient Protection and Affordable Care Act, 26
  367  U.S.C. s. 5000A.
  368         Section 6. The sections created and amendments made by this
  369  act to ss. 409.967, 627.42392, 641.31, and 641.394, Florida
  370  Statutes, may be known as the “Right Medicine Right Time Act.”
  371         Section 7. Effective January 1, 2017, paragraph (c) of
  372  subsection (2) of section 409.967, Florida Statutes, is amended
  373  to read:
  374         409.967 Managed care plan accountability.—
  375         (2) The agency shall establish such contract requirements
  376  as are necessary for the operation of the statewide managed care
  377  program. In addition to any other provisions the agency may deem
  378  necessary, the contract must require:
  379         (c) Access.—
  380         1. The agency shall establish specific standards for the
  381  number, type, and regional distribution of providers in managed
  382  care plan networks to ensure access to care for both adults and
  383  children. Each plan must maintain a regionwide network of
  384  providers in sufficient numbers to meet the access standards for
  385  specific medical services for all recipients enrolled in the
  386  plan. The exclusive use of mail-order pharmacies may not be
  387  sufficient to meet network access standards. Consistent with the
  388  standards established by the agency, provider networks may
  389  include providers located outside the region. A plan may
  390  contract with a new hospital facility before the date the
  391  hospital becomes operational if the hospital has commenced
  392  construction, will be licensed and operational by January 1,
  393  2013, and a final order has issued in any civil or
  394  administrative challenge. Each plan shall establish and maintain
  395  an accurate and complete electronic database of contracted
  396  providers, including information about licensure or
  397  registration, locations and hours of operation, specialty
  398  credentials and other certifications, specific performance
  399  indicators, and such other information as the agency deems
  400  necessary. The database must be available online to both the
  401  agency and the public and have the capability to compare the
  402  availability of providers to network adequacy standards and to
  403  accept and display feedback from each provider’s patients. Each
  404  plan shall submit quarterly reports to the agency identifying
  405  the number of enrollees assigned to each primary care provider.
  406         2.a. Each managed care plan must publish any prescribed
  407  drug formulary or preferred drug list on the plan’s website in a
  408  manner that is accessible to and searchable by enrollees and
  409  providers. The plan must update the list within 24 hours after
  410  making a change. Each plan must ensure that the prior
  411  authorization process for prescribed drugs is readily accessible
  412  to health care providers, including posting appropriate contact
  413  information on its website and providing timely responses to
  414  providers. For Medicaid recipients diagnosed with hemophilia who
  415  have been prescribed anti-hemophilic-factor replacement
  416  products, the agency shall provide for those products and
  417  hemophilia overlay services through the agency’s hemophilia
  418  disease management program.
  419         b. If a managed care plan restricts the use of prescribed
  420  drugs through a fail-first protocol, it must establish a clear
  421  and convenient process that a prescribing physician may use to
  422  request an override of the restriction from the managed care
  423  plan. The managed care plan shall grant an override of the
  424  protocol within 24 hours if:
  425         (I) Based on sound clinical evidence, the prescribing
  426  provider concludes that the preferred treatment required under
  427  the fail-first protocol has been ineffective in the treatment of
  428  the enrollee’s disease or medical condition; or
  429         (II) Based on sound clinical evidence or medical and
  430  scientific evidence, the prescribing provider believes that the
  431  preferred treatment required under the fail-first protocol:
  432         (A) Is likely to be ineffective given the known relevant
  433  physical or mental characteristics and medical history of the
  434  enrollee and the known characteristics of the drug regimen; or
  435         (B) Will cause or is likely to cause an adverse reaction or
  436  other physical harm to the enrollee.
  437  
  438  If the prescribing provider follows the fail-first protocol
  439  recommended by the managed care plan for an enrollee, the
  440  duration of treatment under the fail-first protocol may not
  441  exceed a period deemed appropriate by the prescribing provider.
  442  Following such period, if the prescribing provider deems the
  443  treatment provided under the protocol clinically ineffective,
  444  the enrollee is entitled to receive the course of therapy that
  445  the prescribing provider recommends, and the provider is not
  446  required to seek approval of an override of the fail-first
  447  protocol. As used in this subparagraph, the term “fail-first
  448  protocol” means a prescription practice that begins medication
  449  for a medical condition with the most cost-effective drug
  450  therapy and progresses to other more costly or risky therapies
  451  only if necessary.
  452         3. Managed care plans, and their fiscal agents or
  453  intermediaries, must accept prior authorization requests for any
  454  service electronically.
  455         4. Managed care plans serving children in the care and
  456  custody of the Department of Children and Families shall must
  457  maintain complete medical, dental, and behavioral health
  458  encounter information and participate in making such information
  459  available to the department or the applicable contracted
  460  community-based care lead agency for use in providing
  461  comprehensive and coordinated case management. The agency and
  462  the department shall establish an interagency agreement to
  463  provide guidance for the format, confidentiality, recipient,
  464  scope, and method of information to be made available and the
  465  deadlines for submission of the data. The scope of information
  466  available to the department are shall be the data that managed
  467  care plans are required to submit to the agency. The agency
  468  shall determine the plan’s compliance with standards for access
  469  to medical, dental, and behavioral health services; the use of
  470  medications; and followup on all medically necessary services
  471  recommended as a result of early and periodic screening,
  472  diagnosis, and treatment.
  473         Section 8. Effective January 1, 2017, section 627.42392,
  474  Florida Statutes, is created to read:
  475         627.42392Fail-first protocols.—If an insurer restricts the
  476  use of prescribed drugs through a fail-first protocol, it must
  477  establish a clear and convenient process that a prescribing
  478  physician may use to request an override of the restriction from
  479  the insurer. The insurer shall grant an override of the protocol
  480  within 24 hours if:
  481         (1) Based on sound clinical evidence, the prescribing
  482  provider concludes that the preferred treatment required under
  483  the fail-first protocol has been ineffective in the treatment of
  484  the insured’s disease or medical condition; or
  485         (2) Based on sound clinical evidence or medical and
  486  scientific evidence, the prescribing provider believes that the
  487  preferred treatment required under the fail-first protocol:
  488         (a) Is likely to be ineffective given the known relevant
  489  physical or mental characteristics and medical history of the
  490  insured and the known characteristics of the drug regimen; or
  491         (b) Will cause or is likely to cause an adverse reaction or
  492  other physical harm to the insured.
  493  
  494  If the prescribing provider follows the fail-first protocol
  495  recommended by the insurer for an insured, the duration of
  496  treatment under the fail-first protocol may not exceed a period
  497  deemed appropriate by the prescribing provider. Following such
  498  period, if the prescribing provider deems the treatment provided
  499  under the protocol clinically ineffective, the insured is
  500  entitled to receive the course of therapy that the prescribing
  501  provider recommends, and the provider is not required to seek
  502  approval of an override of the fail-first protocol. As used in
  503  this section, the term “fail-first protocol” means a
  504  prescription practice that begins medication for a medical
  505  condition with the most cost-effective drug therapy and
  506  progresses to other more costly or risky therapies only if
  507  necessary.
  508         Section 9. Effective January 1, 2017, subsection (44) is
  509  added to section 641.31, Florida Statutes, to read:
  510         641.31 Health maintenance contracts.—
  511         (44) A health maintenance organization may not require a
  512  health care provider, by contract with another health care
  513  provider, a patient, or another individual or entity, to use a
  514  clinical decision support system or a laboratory benefits
  515  management program before the provider may order clinical
  516  laboratory services or in an attempt to direct or limit the
  517  provider’s medical decisionmaking relating to the use of such
  518  services. This subsection may not be construed to prohibit any
  519  prior authorization requirements that the health maintenance
  520  organization may have regarding the provision of clinical
  521  laboratory services. As used in this subsection, the term:
  522         (a) “Clinical decision support system” means software
  523  designed to direct or assist clinical decisionmaking by matching
  524  the characteristics of an individual patient to a computerized
  525  clinical knowledge base and providing patient-specific
  526  assessments or recommendations based on the match.
  527         (b) “Clinical laboratory services” means the examination of
  528  fluids or other materials taken from the human body, which
  529  examination is ordered by a health care provider for use in the
  530  diagnosis, prevention, or treatment of a disease or in the
  531  identification or assessment of a medical or physical condition.
  532         (c) “Laboratory benefits management program” means a health
  533  maintenance organization protocol that dictates or limits health
  534  care provider decisionmaking relating to the use of clinical
  535  laboratory services.
  536         Section 10. Effective January 1, 2017, section 641.394,
  537  Florida Statutes, is created to read:
  538         641.394 Fail-first protocols.—If a health maintenance
  539  organization restricts the use of prescribed drugs through a
  540  fail-first protocol, it must establish a clear and convenient
  541  process that a prescribing physician may use to request an
  542  override of the restriction from the health maintenance
  543  organization. The health maintenance organization shall grant an
  544  override of the protocol within 24 hours if:
  545         (1) Based on sound clinical evidence, the prescribing
  546  provider concludes that the preferred treatment required under
  547  the fail-first protocol has been ineffective in the treatment of
  548  the subscriber’s disease or medical condition; or
  549         (2) Based on sound clinical evidence or medical and
  550  scientific evidence, the prescribing provider believes that the
  551  preferred treatment required under the fail-first protocol:
  552         (a) Is likely to be ineffective given the known relevant
  553  physical or mental characteristics and medical history of the
  554  subscriber and the known characteristics of the drug regimen; or
  555         (b) Will cause or is likely to cause an adverse reaction or
  556  other physical harm to the subscriber.
  557  
  558  If the prescribing provider follows the fail-first protocol
  559  recommended by the health maintenance organization for a
  560  subscriber, the duration of treatment under the fail-first
  561  protocol may not exceed a period deemed appropriate by the
  562  prescribing provider. Following such period, if the prescribing
  563  provider deems the treatment provided under the protocol
  564  clinically ineffective, the subscriber is entitled to receive
  565  the course of therapy that the prescribing provider recommends,
  566  and the provider is not required to seek approval of an override
  567  of the fail-first protocol. As used in this section, the term
  568  “fail-first protocol” means a prescription practice that begins
  569  medication for a medical condition with the most cost-effective
  570  drug therapy and progresses to other more costly or risky
  571  therapies only if necessary.
  572         Section 11. Paragraphs (a) and (d) of subsection (3) and
  573  subsections (4) and (5) of section 766.1115, Florida Statutes,
  574  are amended to read:
  575         766.1115 Health care providers; creation of agency
  576  relationship with governmental contractors.—
  577         (3) DEFINITIONS.—As used in this section, the term:
  578         (a) “Contract” means an agreement executed in compliance
  579  with this section between a health care provider and a
  580  governmental contractor for volunteer, uncompensated services
  581  which allows the health care provider to deliver health care
  582  services to low-income recipients as an agent of the
  583  governmental contractor. The contract must be for volunteer,
  584  uncompensated services, except as provided in paragraph (4)(g).
  585  For services to qualify as volunteer, uncompensated services
  586  under this section, the health care provider, or any employee or
  587  agent of the health care provider, must receive no compensation
  588  from the governmental contractor for any services provided under
  589  the contract and must not bill or accept compensation from the
  590  recipient, or a public or private third-party payor, for the
  591  specific services provided to the low-income recipients covered
  592  by the contract, except as provided in paragraph (4)(g). A free
  593  clinic as described in subparagraph (d)14. may receive a
  594  legislative appropriation, a grant through a legislative
  595  appropriation, or a grant from a governmental entity or
  596  nonprofit corporation to support the delivery of contracted
  597  services by volunteer health care providers, including the
  598  employment of health care providers to supplement, coordinate,
  599  or support the delivery of such services. The appropriation or
  600  grant for the free clinic does not constitute compensation under
  601  this paragraph from the governmental contractor for services
  602  provided under the contract, nor does receipt or use of the
  603  appropriation or grant constitute the acceptance of compensation
  604  under this paragraph for the specific services provided to the
  605  low-income recipients covered by the contract.
  606         (d) “Health care provider” or “provider” means:
  607         1. A birth center licensed under chapter 383.
  608         2. An ambulatory surgical center licensed under chapter
  609  395.
  610         3. A hospital licensed under chapter 395.
  611         4. A physician or physician assistant licensed under
  612  chapter 458.
  613         5. An osteopathic physician or osteopathic physician
  614  assistant licensed under chapter 459.
  615         6. A chiropractic physician licensed under chapter 460.
  616         7. A podiatric physician licensed under chapter 461.
  617         8. A registered nurse, nurse midwife, licensed practical
  618  nurse, or advanced registered nurse practitioner licensed or
  619  registered under part I of chapter 464 or any facility which
  620  employs nurses licensed or registered under part I of chapter
  621  464 to supply all or part of the care delivered under this
  622  section.
  623         9. A midwife licensed under chapter 467.
  624         10. A health maintenance organization certificated under
  625  part I of chapter 641.
  626         11. A health care professional association and its
  627  employees or a corporate medical group and its employees.
  628         12. Any other medical facility the primary purpose of which
  629  is to deliver human medical diagnostic services or which
  630  delivers nonsurgical human medical treatment, and which includes
  631  an office maintained by a provider.
  632         13. A dentist or dental hygienist licensed under chapter
  633  466.
  634         14. A free clinic that delivers only medical diagnostic
  635  services or nonsurgical medical treatment free of charge to all
  636  low-income recipients.
  637         15. Any other health care professional, practitioner,
  638  provider, or facility under contract with a governmental
  639  contractor, including a student enrolled in an accredited
  640  program that prepares the student for licensure as any one of
  641  the professionals listed in subparagraphs 4.-9.
  642  
  643  The term includes any nonprofit corporation qualified as exempt
  644  from federal income taxation under s. 501(a) of the Internal
  645  Revenue Code, and described in s. 501(c) of the Internal Revenue
  646  Code, which delivers health care services provided by licensed
  647  professionals listed in this paragraph, any federally funded
  648  community health center, and any volunteer corporation or
  649  volunteer health care provider that delivers health care
  650  services.
  651         (4) CONTRACT REQUIREMENTS.—A health care provider that
  652  executes a contract with a governmental contractor to deliver
  653  health care services on or after April 17, 1992, as an agent of
  654  the governmental contractor, or any employee or agent of such
  655  health care provider, is an agent for purposes of s. 768.28(9),
  656  while acting within the scope of duties under the contract, if
  657  the contract complies with the requirements of this section and
  658  regardless of whether the individual treated is later found to
  659  be ineligible. A health care provider, or any employee or agent
  660  of such health care provider, shall continue to be an agent for
  661  purposes of s. 768.28(9) for 30 days after a determination of
  662  ineligibility to allow for treatment until the individual
  663  transitions to treatment by another health care provider. A
  664  health care provider, or any employee or agent of such health
  665  care provider, under contract with the state may not be named as
  666  a defendant in any action arising out of medical care or
  667  treatment provided on or after April 17, 1992, under contracts
  668  entered into under this section. The contract must provide that:
  669         (a) The right of dismissal or termination of any health
  670  care provider delivering services under the contract is retained
  671  by the governmental contractor.
  672         (b) The governmental contractor has access to the patient
  673  records of any health care provider delivering services under
  674  the contract.
  675         (c) Adverse incidents and information on treatment outcomes
  676  must be reported by any health care provider to the governmental
  677  contractor if the incidents and information pertain to a patient
  678  treated under the contract. The health care provider shall
  679  submit the reports required by s. 395.0197. If an incident
  680  involves a professional licensed by the Department of Health or
  681  a facility licensed by the Agency for Health Care
  682  Administration, the governmental contractor shall submit such
  683  incident reports to the appropriate department or agency, which
  684  shall review each incident and determine whether it involves
  685  conduct by the licensee that is subject to disciplinary action.
  686  All patient medical records and any identifying information
  687  contained in adverse incident reports and treatment outcomes
  688  which are obtained by governmental entities under this paragraph
  689  are confidential and exempt from the provisions of s. 119.07(1)
  690  and s. 24(a), Art. I of the State Constitution.
  691         (d) Patient selection and initial referral must be made by
  692  the governmental contractor or the provider. Patients may not be
  693  transferred to the provider based on a violation of the
  694  antidumping provisions of the Omnibus Budget Reconciliation Act
  695  of 1989, the Omnibus Budget Reconciliation Act of 1990, or
  696  chapter 395.
  697         (e) If emergency care is required, the patient need not be
  698  referred before receiving treatment, but must be referred within
  699  48 hours after treatment is commenced or within 48 hours after
  700  the patient has the mental capacity to consent to treatment,
  701  whichever occurs later.
  702         (f) The provider is subject to supervision and regular
  703  inspection by the governmental contractor.
  704         (g) As an agent of the governmental contractor for purposes
  705  of s. 768.28(9), while acting within the scope of duties under
  706  the contract, A health care provider licensed under chapter 466,
  707  as an agent of the governmental contractor for purposes of s.
  708  768.28(9), may allow a patient, or a parent or guardian of the
  709  patient, to voluntarily contribute a monetary amount to cover
  710  costs of dental laboratory work related to the services provided
  711  to the patient within the scope of duties under the contract.
  712  This contribution may not exceed the actual cost of the dental
  713  laboratory charges.
  714  
  715  A governmental contractor that is also a health care provider is
  716  not required to enter into a contract under this section with
  717  respect to the health care services delivered by its employees.
  718         (5) NOTICE OF AGENCY RELATIONSHIP.—The governmental
  719  contractor must provide written notice to each patient, or the
  720  patient’s legal representative, receipt of which must be
  721  acknowledged in writing at the initial visit, that the provider
  722  is an agent of the governmental contractor and that the
  723  exclusive remedy for injury or damage suffered as the result of
  724  any act or omission of the provider or of any employee or agent
  725  thereof acting within the scope of duties pursuant to the
  726  contract is by commencement of an action pursuant to the
  727  provisions of s. 768.28. Thereafter, or with respect to any
  728  federally funded community health center, the notice
  729  requirements may be met by posting in a place conspicuous to all
  730  persons a notice that the health care provider, or federally
  731  funded community health center, is an agent of the governmental
  732  contractor and that the exclusive remedy for injury or damage
  733  suffered as the result of any act or omission of the provider or
  734  of any employee or agent thereof acting within the scope of
  735  duties pursuant to the contract is by commencement of an action
  736  pursuant to the provisions of s. 768.28.
  737         Section 12. Paragraphs (a) and (b) of subsection (9) of
  738  section 768.28, Florida Statutes, are amended to read:
  739         768.28 Waiver of sovereign immunity in tort actions;
  740  recovery limits; limitation on attorney fees; statute of
  741  limitations; exclusions; indemnification; risk management
  742  programs.—
  743         (9)(a) An No officer, employee, or agent of the state or of
  744  any of its subdivisions may not shall be held personally liable
  745  in tort or named as a party defendant in any action for any
  746  injury or damage suffered as a result of any act, event, or
  747  omission of action in the scope of her or his employment or
  748  function, unless such officer, employee, or agent acted in bad
  749  faith or with malicious purpose or in a manner exhibiting wanton
  750  and willful disregard of human rights, safety, or property.
  751  However, such officer, employee, or agent shall be considered an
  752  adverse witness in a tort action for any injury or damage
  753  suffered as a result of any act, event, or omission of action in
  754  the scope of her or his employment or function. The exclusive
  755  remedy for injury or damage suffered as a result of an act,
  756  event, or omission of an officer, employee, or agent of the
  757  state or any of its subdivisions or constitutional officers is
  758  shall be by action against the governmental entity, or the head
  759  of such entity in her or his official capacity, or the
  760  constitutional officer of which the officer, employee, or agent
  761  is an employee, unless such act or omission was committed in bad
  762  faith or with malicious purpose or in a manner exhibiting wanton
  763  and willful disregard of human rights, safety, or property. The
  764  state or its subdivisions are shall not be liable in tort for
  765  the acts or omissions of an officer, employee, or agent
  766  committed while acting outside the course and scope of her or
  767  his employment or committed in bad faith or with malicious
  768  purpose or in a manner exhibiting wanton and willful disregard
  769  of human rights, safety, or property.
  770         (b) As used in this subsection, the term:
  771         1. “Employee” includes any volunteer firefighter.
  772         2. “Officer, employee, or agent” includes, but is not
  773  limited to, any health care provider, and its employees or
  774  agents, when providing services pursuant to s. 766.1115; any
  775  nonprofit independent college or university located and
  776  chartered in this state which owns or operates an accredited
  777  medical school, and its employees or agents, when providing
  778  patient services pursuant to paragraph (10)(f); and any public
  779  defender or her or his employee or agent, including, among
  780  others, an assistant public defender or and an investigator.
  781         Section 13. Except as otherwise expressly provided in this
  782  act, this act shall take effect July 1, 2016.
  783  
  784  ================= T I T L E  A M E N D M E N T ================
  785  And the title is amended as follows:
  786         Delete everything before the enacting clause
  787  and insert:
  788                        A bill to be entitled                      
  789         An act relating to health care; creating s. 381.4019,
  790         F.S.; establishing a joint local and state dental care
  791         access account initiative, subject to the availability
  792         of funding; authorizing the creation of dental care
  793         access accounts; specifying the purpose of the
  794         initiative; defining terms; providing criteria for the
  795         selection of dentists for participation in the
  796         initiative; providing for the establishment of
  797         accounts; requiring the Department of Health to
  798         implement an electronic benefit transfer system;
  799         providing for the use of funds deposited in the
  800         accounts; requiring the department to distribute state
  801         funds to accounts, subject to legislative
  802         appropriations; authorizing the department to accept
  803         contributions from a local source for deposit in a
  804         designated account; limiting the number of years that
  805         an account may remain open; providing for the
  806         immediate closing of accounts under certain
  807         circumstances; authorizing the department to transfer
  808         state funds remaining in a closed account at a
  809         specified time and to return unspent funds from local
  810         sources; requiring a dentist to repay funds in certain
  811         circumstances; authorizing the department to pursue
  812         disciplinary enforcement actions and to use other
  813         legal means to recover funds; requiring the department
  814         to establish by rule application procedures and a
  815         process to verify the use of funds withdrawn from a
  816         dental care access account; requiring the department
  817         to give priority to applications from dentists
  818         practicing in certain areas; requiring the Department
  819         of Economic Opportunity to rank dental health
  820         professional shortage areas and medically underserved
  821         areas; requiring the Department of Health to develop a
  822         marketing plan in cooperation with certain dental
  823         colleges and the Florida Dental Association; requiring
  824         the Department of Health to annually submit a report
  825         with certain information to the Governor and the
  826         Legislature; providing rulemaking authority to require
  827         the submission of information for such reporting;
  828         amending s. 395.002, F.S.; revising the definition of
  829         the term “ambulatory surgical center” or “mobile
  830         surgical facility”; amending s. 395.003, F.S.;
  831         requiring, as a condition of licensure and license
  832         renewal, that ambulatory surgical centers provide
  833         services to specified patients in at least a specified
  834         amount; requiring ambulatory surgical centers to
  835         report certain data; defining a term; requiring
  836         ambulatory surgical centers to comply with certain
  837         building and lifesafety codes in certain
  838         circumstances; amending s. 395.0191, F.S.; defining
  839         terms; conforming cross-references; requiring a
  840         certain percentage of surgical assistants and surgical
  841         technologists employed or contracting with a hospital
  842         to be certified; providing exceptions to the
  843         certification requirement; creating s. 624.27, F.S.;
  844         defining terms; specifying that a direct primary care
  845         agreement does not constitute insurance and is not
  846         subject to ch. 636, F.S., relating to prepaid limited
  847         health service organizations and discount medical plan
  848         organizations, or any other chapter of the Florida
  849         Insurance Code; specifying that entering into a direct
  850         primary care agreement does not constitute the
  851         business of insurance and is not subject to ch. 636,
  852         F.S., or any other chapter of the code; providing that
  853         certain certificates of authority and licenses are not
  854         required to market, sell, or offer to sell a direct
  855         primary care agreement; specifying requirements for a
  856         direct primary care agreement; providing a short
  857         title; amending s. 409.967, F.S.; requiring a managed
  858         care plan to establish a process by which a
  859         prescribing physician may request an override of
  860         certain restrictions in certain circumstances;
  861         providing the circumstances under which an override
  862         must be granted; defining the term “fail-first
  863         protocol”; creating s. 627.42392, F.S.; requiring an
  864         insurer to establish a process by which a prescribing
  865         physician may request an override of certain
  866         restrictions in certain circumstances; providing the
  867         circumstances under which an override must be granted;
  868         defining the term “fail-first protocol”; amending s.
  869         641.31, F.S.; prohibiting a health maintenance
  870         organization from requiring that a health care
  871         provider use a clinical decision support system or a
  872         laboratory benefits management program in certain
  873         circumstances; defining terms; providing for
  874         construction; creating s. 641.394, F.S.; requiring a
  875         health maintenance organization to establish a process
  876         by which a prescribing physician may request an
  877         override of certain restrictions in certain
  878         circumstances; providing the circumstances under which
  879         an override must be granted; defining the term “fail
  880         first protocol”; amending s. 766.1115, F.S.; revising
  881         the definitions of the terms “contract” and “health
  882         care provider”; deleting an obsolete date; extending
  883         sovereign immunity to employees or agents of a health
  884         care provider that executes a contract with a
  885         governmental contractor; clarifying that a receipt of
  886         specified notice must be acknowledged by a patient or
  887         the patient’s representative at the initial visit;
  888         requiring the posting of notice that a specified
  889         health care provider is an agent of a governmental
  890         contractor; amending s. 768.28, F.S.; revising the
  891         definition of the term “officer, employee, or agent”
  892         to include employees or agents of a health care
  893         provider as it applies to immunity from personal
  894         liability in certain actions; providing effective
  895         dates.