Florida Senate - 2019              PROPOSED COMMITTEE SUBSTITUTE
       Bill No. CS for SB 1712
       Proposed Committee Substitute by the Committee on Appropriations
       (Appropriations Subcommittee on Health and Human Services)
    1                        A bill to be entitled                      
    2         An act relating to hospital licensure; amending s.
    3         395.003, F.S.; deleting an obsolete provision;
    4         providing applicability; requiring certain hospitals
    5         licensed after a specified date to submit a notice to
    6         the Agency for Health Care Administration which
    7         contains specified information before filing for
    8         approval of plans and specifications to establish a
    9         new general hospital; prohibiting the agency from
   10         licensing a new general hospital unless certain
   11         criteria are met; requiring certain hospitals to
   12         participate in the Medicaid program and the Medicare
   13         program and to provide a certain amount of charity
   14         care; defining the terms “charity care” and
   15         “district”; providing a separate calculation of
   16         required charity care for such hospitals located in a
   17         medically underserved area; authorizing such hospitals
   18         to provide a certain donation to the agency’s Grants
   19         and Donations Trust Fund in lieu of providing the
   20         required charity care; requiring such hospitals to
   21         annually report compliance to the agency; requiring
   22         the agency to impose a specified administrative fine
   23         for noncompliance; requiring the agency to adopt
   24         rules; repealing s. 395.6025, F.S., relating to rural
   25         hospital replacement facilities; amending s. 408.032,
   26         F.S.; revising the definition of the term “health care
   27         facility” to eliminate a reference to long-term care
   28         hospitals; deleting the definition of the term “long
   29         term care hospital”; amending s. 408.034; authoring
   30         the agency to issue a license to a general hospital
   31         that has not been issued a certificate of need under
   32         certain circumstances; amending s. 408.035, F.S.;
   33         deleting provisions related to the agency’s
   34         consideration and review of certificates of need for
   35         general hospitals; amending s. 408.036, F.S.;
   36         providing an exception for the construction or
   37         establishment of a general hospital and the conversion
   38         to a general hospital from certificate of need review
   39         requirements; amending ss. 408.037 and 408.039, F.S.;
   40         deleting provisions relating to certificate of need
   41         applications for general hospitals; amending s.
   42         408.040, F.S.; requiring the agency to assess a
   43         specified administrative fine against the holder of a
   44         certificate of need or the holder of an exemption
   45         which fails to comply with specified conditions;
   46         requiring a general hospital that was issued a
   47         certificate of need with certain conditions to
   48         continue to meet those conditions to maintain
   49         licensure; amending s. 408.043, F.S.; deleting
   50         provisions relating to certificates of need for
   51         osteopathic acute care hospitals; prohibiting the
   52         agency from initiating a review cycle or from
   53         accepting letters of intent or applications for the
   54         issuance of certificate of need for the new
   55         construction or the establishment of a freestanding
   56         hospital; requiring the agency to issue such a
   57         certificate of need to certain applicants, regardless
   58         of litigation status; providing applicability;
   59         providing effective dates.
   61  Be It Enacted by the Legislature of the State of Florida:
   63         Section 1. Present subsections (8), (9), and (10) of
   64  section 395.003, Florida Statutes, are redesignated as
   65  subsections (9), (10), and (11), respectively, paragraph (c) of
   66  subsection (1) and present subsections (9) and (10) of that
   67  section are amended, and a new subsection (8) is added to that
   68  section, to read:
   69         395.003 Licensure; denial, suspension, and revocation.—
   70         (1)
   71         (c) Until July 1, 2006, additional emergency departments
   72  located off the premises of licensed hospitals may not be
   73  authorized by the agency.
   74         (8) Applicable only to a general hospital that is, or will
   75  be, newly licensed on or after July 1, 2019; that does not hold
   76  a certificate of need issued by the agency; and that is not
   77  replacing a currently operating general hospital located within
   78  1 mile of the newly licensed hospital:
   79         (a)When proposing a new general hospital project subject
   80  to this subsection and before filing for approval of plans and
   81  specifications under s. 395.0163, each prospective applicant for
   82  licensure must submit a notice to the agency of its intent to
   83  establish a newly licensed hospital which includes the location
   84  for the proposed hospital, the number and types of beds to be
   85  licensed, and the services that the hospital will offer.
   86         (b) Other than a long-term care hospital, the agency may
   87  not license a new general hospital subject to this subsection
   88  unless:
   89         1. The hospital has at least 100 beds and has intensive
   90  care, progressive care, and medical-surgical beds. This
   91  requirement does not apply if the hospital is a rural hospital,
   92  as defined in s. 395.602, or is located in a medically
   93  underserved area; and
   94         2. The hospital has an onsite emergency department that
   95  will operate 24 hours per day, 7 days per week.
   96         (c) Each such hospital must participate in the state
   97  Medicaid program and the Medicare program.
   98         (d) Except as provided in paragraph (e), each such hospital
   99  must provide charity care in an amount equal to or greater than
  100  the district average for hospitals in the applicable district.
  101  The agency shall adopt by rule a method for calculating the
  102  district average for charity care for each district. For
  103  purposes of this subsection, the term “charity care” has the
  104  same meaning as in s. 409.911(1) and the term “district” has the
  105  same meaning as in s. 408.032.
  106         (e) If such a hospital is located in a medically
  107  underserved area, the amount of charity care required to be
  108  provided by the hospital under paragraph (d) is equivalent in
  109  percentage to the medically underserved area’s Index of Medical
  110  Underservice score as calculated by the federal Health Resources
  111  and Services Administration within the Department of Health and
  112  Human Services.
  113         (f) In lieu of providing charity care under paragraph (d)
  114  or paragraph (e), each such hospital may donate an amount
  115  determined by the agency to be functionally equivalent to the
  116  amounts required under those paragraphs to the agency’s Grants
  117  and Donations Trust Fund.
  118         (g) Each such hospital shall annually report to the agency
  119  its compliance with paragraphs (c)-(f). Failure to report
  120  compliance constitutes noncompliance. The agency shall assess an
  121  administrative fine on a hospital that fails to comply with this
  122  subsection in the amount of 1 percent of its net revenue for
  123  each 0.5 percent of the required amount of charity care not
  124  provided pursuant to paragraph (d) or paragraph (e) or the
  125  required amount as determined by the agency pursuant to
  126  paragraph (f).
  127         (h) The agency shall adopt rules to implement this
  128  subsection.
  129         (10)(9) A hospital licensed as of June 1, 2004, is shall be
  130  exempt from subsection (9) (8) as long as the hospital maintains
  131  the same ownership, facility street address, and range of
  132  services that were in existence on June 1, 2004. Any transfer of
  133  beds, or other agreements that result in the establishment of a
  134  hospital or hospital services within the intent of this section,
  135  shall be subject to subsection (9) (8). Unless the hospital is
  136  otherwise exempt under subsection (9) (8), the agency shall deny
  137  or revoke the license of a hospital that violates any of the
  138  criteria set forth in that subsection.
  139         (11)(10) The agency may adopt rules implementing the
  140  licensure requirements set forth in subsection (9) (8). Within
  141  14 days after rendering its decision on a license application or
  142  revocation, the agency shall publish its proposed decision in
  143  the Florida Administrative Register. Within 21 days after
  144  publication of the agency’s decision, any authorized person may
  145  file a request for an administrative hearing. In administrative
  146  proceedings challenging the approval, denial, or revocation of a
  147  license pursuant to subsection (9) (8), the hearing must be
  148  based on the facts and law existing at the time of the agency’s
  149  proposed agency action. Existing hospitals may initiate or
  150  intervene in an administrative hearing to approve, deny, or
  151  revoke licensure under subsection (9) (8) based upon a showing
  152  that an established program will be substantially affected by
  153  the issuance or renewal of a license to a hospital within the
  154  same district or service area.
  155         Section 2. Section 395.6025, Florida Statutes, is repealed.
  156         Section 3. Subsections (8) and (13) of section 408.032,
  157  Florida Statutes, are amended to read:
  158         408.032 Definitions relating to Health Facility and
  159  Services Development Act.—As used in ss. 408.031-408.045, the
  160  term:
  161         (8) “Health care facility” means a hospital, long-term care
  162  hospital, skilled nursing facility, hospice, or intermediate
  163  care facility for the developmentally disabled. A facility
  164  relying solely on spiritual means through prayer for healing is
  165  not included as a health care facility.
  166         (13) “Long-term care hospital” means a hospital licensed
  167  under chapter 395 which meets the requirements of 42 C.F.R. s.
  168  412.23(e) and seeks exclusion from the acute care Medicare
  169  prospective payment system for inpatient hospital services.
  170         Section 4. Subsection (2) of section 408.034, Florida
  171  Statutes, is amended to read:
  172         408.034 Duties and responsibilities of agency; rules.—
  173         (2) In the exercise of its authority to issue licenses to
  174  health care facilities and health service providers, as provided
  175  under chapters 393 and 395 and parts II, IV, and VIII of chapter
  176  400, the agency may not issue a license to any health care
  177  facility or health service provider that fails to receive a
  178  certificate of need or an exemption for the licensed facility or
  179  service, except that the agency may issue a license to a general
  180  hospital that has not been issued a certificate of need if that
  181  hospital meets the criteria established in s. 395.003(8).
  182         Section 5. Section 408.035, Florida Statutes, is amended to
  183  read:
  184         408.035 Review criteria.—
  185         (1) The agency shall determine the reviewability of
  186  applications and shall review applications for certificate-of
  187  need determinations for health care facilities and health
  188  services in context with the following criteria, except for
  189  general hospitals as defined in s. 395.002:
  190         (1)(a) The need for the health care facilities and health
  191  services being proposed.
  192         (2)(b) The availability, quality of care, accessibility,
  193  and extent of utilization of existing health care facilities and
  194  health services in the service district of the applicant.
  195         (3)(c) The ability of the applicant to provide quality of
  196  care and the applicant’s record of providing quality of care.
  197         (4)(d) The availability of resources, including health
  198  personnel, management personnel, and funds for capital and
  199  operating expenditures, for project accomplishment and
  200  operation.
  201         (5)(e) The extent to which the proposed services will
  202  enhance access to health care for residents of the service
  203  district.
  204         (6)(f) The immediate and long-term financial feasibility of
  205  the proposal.
  206         (7)(g) The extent to which the proposal will foster
  207  competition that promotes quality and cost-effectiveness.
  208         (8)(h) The costs and methods of the proposed construction,
  209  including the costs and methods of energy provision and the
  210  availability of alternative, less costly, or more effective
  211  methods of construction.
  212         (9)(i) The applicant’s past and proposed provision of
  213  health care services to Medicaid patients and the medically
  214  indigent.
  215         (10)(j) The applicant’s designation as a Gold Seal Program
  216  nursing facility pursuant to s. 400.235, when the applicant is
  217  requesting additional nursing home beds at that facility.
  218         (2) For a general hospital, the agency shall consider only
  219  the criteria specified in paragraph (1)(a), paragraph (1)(b),
  220  except for quality of care in paragraph (1)(b), and paragraphs
  221  (1)(e), (g), and (i).
  222         Section 6. Paragraphs (b) and (c) of subsection (1) of
  223  section 408.036, Florida Statutes, are amended to read:
  224         408.036 Projects subject to review; exemptions.—
  225         (1) APPLICABILITY.—Unless exempt under subsection (3), all
  226  health-care-related projects, as described in paragraphs (a)
  227  (f), are subject to review and must file an application for a
  228  certificate of need with the agency. The agency is exclusively
  229  responsible for determining whether a health-care-related
  230  project is subject to review under ss. 408.031-408.045.
  231         (b) The new construction or establishment of additional
  232  health care facilities, except for the construction of or
  233  establishment of a general hospital or including a replacement
  234  health care facility when the proposed project site is not
  235  located on the same site as or within 1 mile of the existing
  236  health care facility, if the number of beds in each licensed bed
  237  category will not increase.
  238         (c) The conversion from one type of health care facility to
  239  another, including the conversion from a general hospital, a
  240  specialty hospital, or a long-term care hospital, except that a
  241  conversion to a general hospital is not subject to review if,
  242  once converted, the hospital meets the licensure criteria in s.
  243  395.003(8).
  244         Section 7. Section 408.037, Florida Statutes, is amended to
  245  read:
  246         408.037 Application content.—
  247         (1) Except as provided in subsection (2) for a general
  248  hospital, An application for a certificate of need must contain:
  249         (a) A detailed description of the proposed project and
  250  statement of its purpose and need in relation to the district
  251  health plan.
  252         (b) A statement of the financial resources needed by and
  253  available to the applicant to accomplish the proposed project.
  254  This statement must include:
  255         1. A complete listing of all capital projects, including
  256  new health facility development projects and health facility
  257  acquisitions applied for, pending, approved, or underway in any
  258  state at the time of application, regardless of whether or not
  259  that state has a certificate-of-need program or a capital
  260  expenditure review program pursuant to s. 1122 of the Social
  261  Security Act. The agency may, by rule, require less-detailed
  262  information from major health care providers. This listing must
  263  include the applicant’s actual or proposed financial commitment
  264  to those projects and an assessment of their impact on the
  265  applicant’s ability to provide the proposed project.
  266         2. A detailed listing of the needed capital expenditures,
  267  including sources of funds.
  268         3. A detailed financial projection, including a statement
  269  of the projected revenue and expenses for the first 2 years of
  270  operation after completion of the proposed project. This
  271  statement must include a detailed evaluation of the impact of
  272  the proposed project on the cost of other services provided by
  273  the applicant.
  274         (c) An audited financial statement of the applicant or the
  275  applicant’s parent corporation if audited financial statements
  276  of the applicant do not exist. In an application submitted by an
  277  existing health care facility, health maintenance organization,
  278  or hospice, financial condition documentation must include, but
  279  need not be limited to, a balance sheet and a profit-and-loss
  280  statement of the 2 previous fiscal years’ operation.
  281         (2) An application for a certificate of need for a general
  282  hospital must contain a detailed description of the proposed
  283  general hospital project and a statement of its purpose and the
  284  needs it will meet. The proposed project’s location, as well as
  285  its primary and secondary service areas, must be identified by
  286  zip code. Primary service area is defined as the zip codes from
  287  which the applicant projects that it will draw 75 percent of its
  288  discharges. Secondary service area is defined as the zip codes
  289  from which the applicant projects that it will draw its
  290  remaining discharges. If, subsequent to issuance of a final
  291  order approving the certificate of need, the proposed location
  292  of the general hospital changes or the primary service area
  293  materially changes, the agency shall revoke the certificate of
  294  need. However, if the agency determines that such changes are
  295  deemed to enhance access to hospital services in the service
  296  district, the agency may permit such changes to occur. A party
  297  participating in the administrative hearing regarding the
  298  issuance of the certificate of need for a general hospital has
  299  standing to participate in any subsequent proceeding regarding
  300  the revocation of the certificate of need for a hospital for
  301  which the location has changed or for which the primary service
  302  area has materially changed. In addition, the application for
  303  the certificate of need for a general hospital must include a
  304  statement of intent that, if approved by final order of the
  305  agency, the applicant shall within 120 days after issuance of
  306  the final order or, if there is an appeal of the final order,
  307  within 120 days after the issuance of the court’s mandate on
  308  appeal, furnish satisfactory proof of the applicant’s financial
  309  ability to operate. The agency shall establish documentation
  310  requirements, to be completed by each applicant, which show
  311  anticipated provider revenues and expenditures, the basis for
  312  financing the anticipated cash-flow requirements of the
  313  provider, and an applicant’s access to contingency financing. A
  314  party participating in the administrative hearing regarding the
  315  issuance of the certificate of need for a general hospital may
  316  provide written comments concerning the adequacy of the
  317  financial information provided, but such party does not have
  318  standing to participate in an administrative proceeding
  319  regarding proof of the applicant’s financial ability to operate.
  320  The agency may require a licensee to provide proof of financial
  321  ability to operate at any time if there is evidence of financial
  322  instability, including, but not limited to, unpaid expenses
  323  necessary for the basic operations of the provider.
  324         (2)(3) The applicant must certify that it will license and
  325  operate the health care facility. For an existing health care
  326  facility, the applicant must be the licenseholder of the
  327  facility.
  328         Section 8. Paragraphs (c) and (d) of subsection (3),
  329  paragraphs (b) and (c) of subsection (5), and paragraph (d) of
  330  subsection (6) of section 408.039, Florida Statutes, are amended
  331  to read:
  332         408.039 Review process.—The review process for certificates
  333  of need shall be as follows:
  334         (3) APPLICATION PROCESSING.—
  335         (c) Except for competing applicants, in order to be
  336  eligible to challenge the agency decision on a general hospital
  337  application under review pursuant to paragraph (5)(c), existing
  338  hospitals must submit a detailed written statement of opposition
  339  to the agency and to the applicant. The detailed written
  340  statement must be received by the agency and the applicant
  341  within 21 days after the general hospital application is deemed
  342  complete and made available to the public.
  343         (d) In those cases where a written statement of opposition
  344  has been timely filed regarding a certificate of need
  345  application for a general hospital, the applicant for the
  346  general hospital may submit a written response to the agency.
  347  Such response must be received by the agency within 10 days of
  348  the written statement due date.
  350         (b) Hearings shall be held in Tallahassee unless the
  351  administrative law judge determines that changing the location
  352  will facilitate the proceedings. The agency shall assign
  353  proceedings requiring hearings to the Division of Administrative
  354  Hearings of the Department of Management Services within 10 days
  355  after the time has expired for requesting a hearing. Except upon
  356  unanimous consent of the parties or upon the granting by the
  357  administrative law judge of a motion of continuance, hearings
  358  shall commence within 60 days after the administrative law judge
  359  has been assigned. For an application for a general hospital,
  360  administrative hearings shall commence within 6 months after the
  361  administrative law judge has been assigned, and a continuance
  362  may not be granted absent a finding of extraordinary
  363  circumstances by the administrative law judge. All parties,
  364  except the agency, shall bear their own expense of preparing a
  365  transcript. In any application for a certificate of need which
  366  is referred to the Division of Administrative Hearings for
  367  hearing, the administrative law judge shall complete and submit
  368  to the parties a recommended order as provided in ss. 120.569
  369  and 120.57. The recommended order shall be issued within 30 days
  370  after the receipt of the proposed recommended orders or the
  371  deadline for submission of such proposed recommended orders,
  372  whichever is earlier. The division shall adopt procedures for
  373  administrative hearings which shall maximize the use of
  374  stipulated facts and shall provide for the admission of prepared
  375  testimony.
  376         (c) In administrative proceedings challenging the issuance
  377  or denial of a certificate of need, only applicants considered
  378  by the agency in the same batching cycle are entitled to a
  379  comparative hearing on their applications. Existing health care
  380  facilities may initiate or intervene in an administrative
  381  hearing upon a showing that an established program will be
  382  substantially affected by the issuance of any certificate of
  383  need, whether reviewed under s. 408.036(1) or (2), to a
  384  competing proposed facility or program within the same district.
  385  With respect to an application for a general hospital, competing
  386  applicants and only those existing hospitals that submitted a
  387  detailed written statement of opposition to an application as
  388  provided in this paragraph may initiate or intervene in an
  389  administrative hearing. Such challenges to a general hospital
  390  application shall be limited in scope to the issues raised in
  391  the detailed written statement of opposition that was provided
  392  to the agency. The administrative law judge may, upon a motion
  393  showing good cause, expand the scope of the issues to be heard
  394  at the hearing. Such motion shall include substantial and
  395  detailed facts and reasons for failure to include such issues in
  396  the original written statement of opposition.
  397         (6) JUDICIAL REVIEW.—
  398         (d) The party appealing a final order that grants a general
  399  hospital certificate of need shall pay the appellee’s attorney’s
  400  fees and costs, in an amount up to $1 million, from the
  401  beginning of the original administrative action if the appealing
  402  party loses the appeal, subject to the following limitations and
  403  requirements:
  404         1. The party appealing a final order must post a bond in
  405  the amount of $1 million in order to maintain the appeal.
  406         2. Except as provided under s. 120.595(5), in no event
  407  shall the agency be held liable for any other party’s attorney’s
  408  fees or costs.
  409         Section 9. Subsection (1) of section 408.040, Florida
  410  Statutes, is amended, to read:
  411         408.040 Conditions and monitoring.—
  412         (1)(a) The agency may issue a certificate of need, or an
  413  exemption, predicated upon statements of intent expressed by an
  414  applicant in the application for a certificate of need or an
  415  exemption. Any conditions imposed on a certificate of need or an
  416  exemption based on such statements of intent shall be stated on
  417  the face of the certificate of need or in the exemption
  418  approval.
  419         (b) The agency may consider, in addition to the other
  420  criteria specified in s. 408.035, a statement of intent by the
  421  applicant that a specified percentage of the annual patient days
  422  at the facility will be utilized by patients eligible for care
  423  under Title XIX of the Social Security Act. Any certificate of
  424  need issued to a nursing home in reliance upon an applicant’s
  425  statements that a specified percentage of annual patient days
  426  will be utilized by residents eligible for care under Title XIX
  427  of the Social Security Act must include a statement that such
  428  certification is a condition of issuance of the certificate of
  429  need. The certificate-of-need program shall notify the Medicaid
  430  program office and the Department of Elderly Affairs when it
  431  imposes conditions as authorized in this paragraph in an area in
  432  which a community diversion pilot project is implemented.
  433  Effective July 1, 2012, the agency may not impose sanctions
  434  related to patient day utilization by patients eligible for care
  435  under Title XIX of the Social Security Act for nursing homes.
  436         (c) A certificateholder or an exemption holder may apply to
  437  the agency for a modification of conditions imposed under
  438  paragraph (a) or paragraph (b). If the holder of a certificate
  439  of need or an exemption demonstrates good cause why the
  440  certificate or exemption should be modified, the agency shall
  441  reissue the certificate of need or exemption with such
  442  modifications as may be appropriate. The agency shall by rule
  443  define the factors constituting good cause for modification.
  444         (d) If the holder of a certificate of need or the holder of
  445  an exemption fails to comply with a condition that is unrelated
  446  to the provision of charity care or the provision of care under
  447  the Florida Medicaid program upon which the issuance of the
  448  certificate or exemption was predicated, the agency may assess
  449  an administrative fine against the certificateholder or
  450  exemption holder in an amount not to exceed $1,000 per failure
  451  per day. If the holder of a certificate of need or the holder of
  452  an exemption fails to comply with a condition related to the
  453  provision of charity care or the provision of care under the
  454  Florida Medicaid program upon which the issuance of the
  455  certificate or exemption was predicated, the agency must assess
  456  an administrative fine against the certificateholder or
  457  exemption holder in the amount of $2,500 per day for each
  458  instance of noncompliance. Failure to annually report compliance
  459  with any condition upon which the issuance of the certificate or
  460  exemption was predicated constitutes noncompliance. In assessing
  461  the penalty, the agency shall take into account as mitigation
  462  the degree of noncompliance. Proceeds of such penalties shall be
  463  deposited in the Public Medical Assistance Trust Fund.
  464         (e) A general hospital that was issued a certificate of
  465  need with conditions imposed as described in paragraph (a) or
  466  paragraph (b), relating to the provision of charity care or the
  467  provision of care under the Florida Medicaid program, must
  468  continue to meet those conditions to maintain licensure
  469  regardless of the status of that hospital’s certificate of need
  470  unless such conditions are modified by the agency pursuant to
  471  paragraph (c).
  472         Section 10. Subsection (1) of section 408.043, Florida
  473  Statutes, is amended to read:
  474         408.043 Special provisions.—
  475         (1) OSTEOPATHIC ACUTE CARE HOSPITALS.—When an application
  476  is made for a certificate of need to construct or to expand an
  477  osteopathic acute care hospital, the need for such hospital
  478  shall be determined on the basis of the need for and
  479  availability of osteopathic services and osteopathic acute care
  480  hospitals in the district. When a prior certificate of need to
  481  establish an osteopathic acute care hospital has been issued in
  482  a district, and the facility is no longer used for that purpose,
  483  the agency may continue to count such facility and beds as an
  484  existing osteopathic facility in any subsequent application for
  485  construction of an osteopathic acute care hospital.
  486         Section 11. Effective upon this act becoming a law:
  487         (1) The Agency for Health Care Administration may not
  488  initiate a review cycle or accept letters of intent or
  489  applications for the issuance of a certificate of need for the
  490  new construction or establishment of a freestanding general
  491  hospital.
  492         (2) The agency shall issue a certificate of need to any
  493  pending applicant for a certificate of need for the new
  494  construction of or establishment of a freestanding general
  495  hospital:
  496         (a) With intensive care, progressive care, and medical
  497  surgical beds;
  498         (b) With an onsite emergency department that will be
  499  operational 24 hours per day, 7 days per week; and
  500         (c) Whose application for a certificate of need has been
  501  approved by the agency, regardless of the litigation status of
  502  the application.
  503         (3) For an applicant seeking a certificate of need for the
  504  new construction or establishment of a freestanding general
  505  hospital that does not meet the criteria in subsection (2),
  506  including an applicant whose application is pending approval or
  507  denial by the agency and an applicant whose application was
  508  initially denied by the agency but such denial is under appeal,
  509  ss. 395.6025, 408.032, 408.034, 408.035, 408.036, 408.037,
  510  408.039, and 408.043, Florida Statutes (2018), and any rules
  511  adopted thereunder remain in effect until such time as the
  512  agency has either issued the applicant a certificate of need,
  513  the agency has denied the application and all appeals of the
  514  denial have been exhausted, or the application has been
  515  withdrawn.
  516         Section 12. Except as otherwise expressly provided in this
  517  act and except for this section, which shall take effect upon
  518  this act becoming a law, this act shall take effect July 1,
  519  2019.