Florida Senate - 2018                                    SB 1492
       
       
        
       By Senator Brandes
       
       
       
       
       
       24-01427-18                                           20181492__
    1                        A bill to be entitled                      
    2         An act relating to certificates of need for hospitals;
    3         amending s. 408.032, F.S.; revising and deleting
    4         definitions; amending s. 408.034, F.S.; revising
    5         duties and responsibilities of the Agency for Health
    6         Care Administration relating to issuance of licenses
    7         to health care facilities and health service
    8         providers; conforming provisions to changes made by
    9         the act; amending s. 408.035, F.S.; excluding general
   10         hospitals from certain agency review of applications
   11         for certificate-of-need determinations; amending s.
   12         408.036, F.S.; revising health-care-related projects
   13         subject to agency review for a certificate of need and
   14         exemptions therefrom; deleting provisions requiring
   15         health care facilities and providers to provide
   16         certain notice to the agency upon termination of a
   17         health care service or the addition or delicensure of
   18         beds; conforming a provision; amending ss. 408.037 and
   19         408.039, F.S.; conforming provisions to changes made
   20         by the act; amending s. 408.043, F.S.; deleting
   21         certificate-of-need requirements for osteopathic acute
   22         care hospitals; amending s. 395.1055, F.S.; revising
   23         the agency’s rulemaking authority with respect to
   24         minimum standards for hospitals; requiring hospitals
   25         that provide certain services to meet specified
   26         licensure requirements; conforming provisions to
   27         changes made by the act; repealing s. 395.6025, F.S.,
   28         relating to rural hospital replacement facilities;
   29         amending ss. 395.603, 395.605, and 408.033, F.S.;
   30         conforming provisions to changes made by the act;
   31         amending s. 395.604, F.S.; conforming a cross
   32         reference; amending s. 408.0361, F.S.; deleting
   33         obsolete provisions; providing an effective date.
   34          
   35  Be It Enacted by the Legislature of the State of Florida:
   36  
   37         Section 1. Subsections (8) through (17) of section 408.032,
   38  Florida Statutes, are amended to read:
   39         408.032 Definitions relating to Health Facility and
   40  Services Development Act.—As used in ss. 408.031-408.045, the
   41  term:
   42         (8) “Health care facility” means a hospital, long-term care
   43  hospital, skilled nursing facility, hospice, or intermediate
   44  care facility for the developmentally disabled. A facility
   45  relying solely on spiritual means through prayer for healing is
   46  not included as a health care facility.
   47         (9)“Health services” means inpatient diagnostic, curative,
   48  or comprehensive medical rehabilitative services and includes
   49  mental health services. Obstetric services are not health
   50  services for purposes of ss. 408.031-408.045.
   51         (9)(10) “Hospice” or “hospice program” means a hospice as
   52  defined in part IV of chapter 400.
   53         (11)“Hospital” means a health care facility licensed under
   54  chapter 395.
   55         (10)(12) “Intermediate care facility for the
   56  developmentally disabled” means a residential facility licensed
   57  under part VIII of chapter 400.
   58         (13)“Long-term care hospital” means a hospital licensed
   59  under chapter 395 which meets the requirements of 42 C.F.R. s.
   60  412.23(e) and seeks exclusion from the acute care Medicare
   61  prospective payment system for inpatient hospital services.
   62         (14)“Mental health services” means inpatient services
   63  provided in a hospital licensed under chapter 395 and listed on
   64  the hospital license as psychiatric beds for adults; psychiatric
   65  beds for children and adolescents; intensive residential
   66  treatment beds for children and adolescents; substance abuse
   67  beds for adults; or substance abuse beds for children and
   68  adolescents.
   69         (11)(15) “Nursing home geographically underserved area”
   70  means:
   71         (a) A county in which there is no existing or approved
   72  nursing home;
   73         (b) An area with a radius of at least 20 miles in which
   74  there is no existing or approved nursing home; or
   75         (c) An area with a radius of at least 20 miles in which all
   76  existing nursing homes have maintained at least a 95 percent
   77  occupancy rate for the most recent 6 months or a 90 percent
   78  occupancy rate for the most recent 12 months.
   79         (12)(16) “Skilled nursing facility” means an institution,
   80  or a distinct part of an institution, which is primarily engaged
   81  in providing, to inpatients, skilled nursing care and related
   82  services for patients who require medical or nursing care, or
   83  rehabilitation services for the rehabilitation of injured,
   84  disabled, or sick persons.
   85         (17)“Tertiary health service” means a health service
   86  which, due to its high level of intensity, complexity,
   87  specialized or limited applicability, and cost, should be
   88  limited to, and concentrated in, a limited number of hospitals
   89  to ensure the quality, availability, and cost-effectiveness of
   90  such service. Examples of such service include, but are not
   91  limited to, pediatric cardiac catheterization, pediatric open
   92  heart surgery, organ transplantation, neonatal intensive care
   93  units, comprehensive rehabilitation, and medical or surgical
   94  services which are experimental or developmental in nature to
   95  the extent that the provision of such services is not yet
   96  contemplated within the commonly accepted course of diagnosis or
   97  treatment for the condition addressed by a given service. The
   98  agency shall establish by rule a list of all tertiary health
   99  services.
  100         Section 2. Subsections (2) and (3) of section 408.034,
  101  Florida Statutes, are amended to read:
  102         408.034 Duties and responsibilities of agency; rules.—
  103         (2) In the exercise of its authority to issue licenses to
  104  health care facilities and health service providers, as provided
  105  under chapter chapters 393 and 395 and parts II, IV, and VIII of
  106  chapter 400, the agency may not issue a license to any health
  107  care facility or health service provider that fails to receive a
  108  certificate of need or an exemption for the licensed facility or
  109  service.
  110         (3) The agency shall establish, by rule, uniform need
  111  methodologies for health services and health facilities. In
  112  developing uniform need methodologies, the agency shall, at a
  113  minimum, consider the demographic characteristics of the
  114  population, the health status of the population, service use
  115  patterns, standards and trends, geographic accessibility, and
  116  market economics.
  117         Section 3. Section 408.035, Florida Statutes, is amended to
  118  read:
  119         408.035 Review criteria.—
  120         (1) The agency shall determine the reviewability of
  121  applications and shall review applications for certificate-of
  122  need determinations for health care facilities and health
  123  services in context with the following criteria, except for
  124  general hospitals as defined in s. 395.002:
  125         (1)(a) The need for the health care facilities and health
  126  services being proposed.
  127         (2)(b) The availability, quality of care, accessibility,
  128  and extent of utilization of existing health care facilities and
  129  health services in the service district of the applicant.
  130         (3)(c) The ability of the applicant to provide quality of
  131  care and the applicant’s record of providing quality of care.
  132         (4)(d) The availability of resources, including health
  133  personnel, management personnel, and funds for capital and
  134  operating expenditures, for project accomplishment and
  135  operation.
  136         (5)(e) The extent to which the proposed services will
  137  enhance access to health care for residents of the service
  138  district.
  139         (6)(f) The immediate and long-term financial feasibility of
  140  the proposal.
  141         (7)(g) The extent to which the proposal will foster
  142  competition that promotes quality and cost-effectiveness.
  143         (8)(h) The costs and methods of the proposed construction,
  144  including the costs and methods of energy provision and the
  145  availability of alternative, less costly, or more effective
  146  methods of construction.
  147         (9)(i) The applicant’s past and proposed provision of
  148  health care services to Medicaid patients and the medically
  149  indigent.
  150         (10)(j) The applicant’s designation as a Gold Seal Program
  151  nursing facility pursuant to s. 400.235, when the applicant is
  152  requesting additional nursing home beds at that facility.
  153         (2)For a general hospital, the agency shall consider only
  154  the criteria specified in paragraph (1)(a), paragraph (1)(b),
  155  except for quality of care in paragraph (1)(b), and paragraphs
  156  (1)(e), (g), and (i).
  157         Section 4. Section 408.036, Florida Statutes, is amended to
  158  read:
  159         408.036 Projects subject to review; exemptions.—
  160         (1) APPLICABILITY.—Unless exempt under subsection (3), all
  161  health-care-related projects, as described in this subsection
  162  paragraphs (a)-(f), are subject to review and must file an
  163  application for a certificate of need with the agency. The
  164  agency is exclusively responsible for determining whether a
  165  health-care-related project is subject to review under ss.
  166  408.031-408.045.
  167         (a) The addition of beds in community nursing homes or
  168  intermediate care facilities for the developmentally disabled by
  169  new construction or alteration.
  170         (b) The new construction or establishment of additional
  171  health care facilities, including a replacement health care
  172  facility when the proposed project site is not located on the
  173  same site as or within 1 mile of the existing health care
  174  facility, if the number of beds in each licensed bed category
  175  will not increase.
  176         (c) The conversion from one type of health care facility to
  177  another, including the conversion from a general hospital, a
  178  specialty hospital, or a long-term care hospital.
  179         (d) The establishment of a hospice or hospice inpatient
  180  facility, except as provided in s. 408.043.
  181         (e)An increase in the number of beds for comprehensive
  182  rehabilitation.
  183         (f)The establishment of tertiary health services,
  184  including inpatient comprehensive rehabilitation services.
  185         (2) PROJECTS SUBJECT TO EXPEDITED REVIEW.—Unless exempt
  186  pursuant to subsection (3), the following projects are subject
  187  to expedited review:
  188         (a) Transfer of a certificate of need, except that when an
  189  existing hospital is acquired by a purchaser, all certificates
  190  of need issued to the hospital which are not yet operational
  191  shall be acquired by the purchaser without need for a transfer.
  192         (b) Replacement of a nursing home, if the proposed project
  193  site is within a 30-mile radius of the replaced nursing home. If
  194  the proposed project site is outside the subdistrict where the
  195  replaced nursing home is located, the prior 6-month occupancy
  196  rate for licensed community nursing homes in the proposed
  197  subdistrict must be at least 85 percent in accordance with the
  198  agency’s most recently published inventory.
  199         (c) Replacement of a nursing home within the same district,
  200  if the proposed project site is outside a 30-mile radius of the
  201  replaced nursing home but within the same subdistrict or a
  202  geographically contiguous subdistrict. If the proposed project
  203  site is in the geographically contiguous subdistrict, the prior
  204  6-month occupancy rate for licensed community nursing homes for
  205  that subdistrict must be at least 85 percent in accordance with
  206  the agency’s most recently published inventory.
  207         (d) Relocation of a portion of a nursing home’s licensed
  208  beds to another facility or to establish a new facility within
  209  the same district or within a geographically contiguous
  210  district, if the relocation is within a 30-mile radius of the
  211  existing facility and the total number of nursing home beds in
  212  the state does not increase.
  213         (e) New construction of a community nursing home in a
  214  retirement community as further provided in this paragraph.
  215         1. Expedited review under this paragraph is available if
  216  all of the following criteria are met:
  217         a. The residential use area of the retirement community is
  218  deed-restricted as housing for older persons as defined in s.
  219  760.29(4)(b).
  220         b. The retirement community is located in a county in which
  221  25 percent or more of its population is age 65 and older.
  222         c. The retirement community is located in a county that has
  223  a rate of no more than 16.1 beds per 1,000 persons age 65 years
  224  or older. The rate shall be determined by using the current
  225  number of licensed and approved community nursing home beds in
  226  the county per the agency’s most recent published inventory.
  227         d. The retirement community has a population of at least
  228  8,000 residents within the county, based on a population data
  229  source accepted by the agency.
  230         e. The number of proposed community nursing home beds in an
  231  application does not exceed the projected bed need after
  232  applying the rate of 16.1 beds per 1,000 persons aged 65 years
  233  and older projected for the county 3 years into the future using
  234  the estimates adopted by the agency reduced by the agency’s most
  235  recently published inventory of licensed and approved community
  236  nursing home beds in the county.
  237         2. No more than 120 community nursing home beds shall be
  238  approved for a qualified retirement community under each request
  239  for expedited review. Subsequent requests for expedited review
  240  under this process may not be made until 2 years after
  241  construction of the facility has commenced or 1 year after the
  242  beds approved through the initial request are licensed,
  243  whichever occurs first.
  244         3. The total number of community nursing home beds which
  245  may be approved for any single deed-restricted community
  246  pursuant to this paragraph may not exceed 240, regardless of
  247  whether the retirement community is located in more than one
  248  qualifying county.
  249         4. Each nursing home facility approved under this paragraph
  250  must be dually certified for participation in the Medicare and
  251  Medicaid programs.
  252         5. Each nursing home facility approved under this paragraph
  253  must be at least 1 mile, as measured over publicly owned
  254  roadways, from an existing approved and licensed community
  255  nursing home.
  256         6. A retirement community requesting expedited review under
  257  this paragraph shall submit a written request to the agency for
  258  expedited review. The request must include the number of beds to
  259  be added and provide evidence of compliance with the criteria
  260  specified in subparagraph 1.
  261         7. After verifying that the retirement community meets the
  262  criteria for expedited review specified in subparagraph 1., the
  263  agency shall publicly notice in the Florida Administrative
  264  Register that a request for an expedited review has been
  265  submitted by a qualifying retirement community and that the
  266  qualifying retirement community intends to make land available
  267  for the construction and operation of a community nursing home.
  268  The agency’s notice must identify where potential applicants can
  269  obtain information describing the sales price of, or terms of
  270  the land lease for, the property on which the project will be
  271  located and the requirements established by the retirement
  272  community. The agency notice must also specify the deadline for
  273  submission of the certificate-of-need application, which may not
  274  be earlier than the 91st day or later than the 125th day after
  275  the date the notice appears in the Florida Administrative
  276  Register.
  277         8. The qualified retirement community shall make land
  278  available to applicants it deems to have met its requirements
  279  for the construction and operation of a community nursing home
  280  but may sell or lease the land only to the applicant that is
  281  issued a certificate of need by the agency under this paragraph.
  282         a. A certificate-of-need application submitted under this
  283  paragraph must identify the intended site for the project within
  284  the retirement community and the anticipated costs for the
  285  project based on that site. The application must also include
  286  written evidence that the retirement community has determined
  287  that both the provider submitting the application and the
  288  project satisfy its requirements for the project.
  289         b. If the retirement community determines that more than
  290  one provider satisfies its requirements for the project, it may
  291  notify the agency of the provider it prefers.
  292         9. The agency shall review each submitted application. If
  293  multiple applications are submitted for a project published
  294  pursuant to subparagraph 7., the agency shall review the
  295  competing applications.
  296  
  297  The agency shall develop rules to implement the expedited review
  298  process, including time schedule, application content that may
  299  be reduced from the full requirements of s. 408.037(1), and
  300  application processing.
  301         (3) EXEMPTIONS.—Upon request, the following projects are
  302  subject to exemption from the provisions of subsection (1):
  303         (a) For hospice services or for swing beds in a rural
  304  hospital, as defined in s. 395.602, in a number that does not
  305  exceed one-half of its licensed beds, or for a hospice program
  306  established by an entity that shares a controlling interest, as
  307  defined in s. 408.803, with a not-for-profit retirement
  308  community that offers independent living, assisted living, and
  309  skilled nursing services provided in a facility on the same
  310  premises and designated by the agency as a teaching nursing home
  311  for a minimum of 5 years, in accordance with s. 430.80. Only one
  312  hospice program per teaching nursing home may be established
  313  under the exemption in this paragraph, and such program shall be
  314  limited to serving patients residing in communities located
  315  within the not-for-profit retirement community, including home
  316  and community-based service providers.
  317         (b)For the conversion of licensed acute care hospital beds
  318  to Medicare and Medicaid certified skilled nursing beds in a
  319  rural hospital, as defined in s. 395.602, so long as the
  320  conversion of the beds does not involve the construction of new
  321  facilities. The total number of skilled nursing beds, including
  322  swing beds, may not exceed one-half of the total number of
  323  licensed beds in the rural hospital as of July 1, 1993.
  324  Certified skilled nursing beds designated under this paragraph,
  325  excluding swing beds, shall be included in the community nursing
  326  home bed inventory. A rural hospital that subsequently
  327  decertifies any acute care beds exempted under this paragraph
  328  shall notify the agency of the decertification, and the agency
  329  shall adjust the community nursing home bed inventory
  330  accordingly.
  331         (b)(c) For the addition of nursing home beds at a skilled
  332  nursing facility that is part of a retirement community that
  333  provides a variety of residential settings and supportive
  334  services and that has been incorporated and operated in this
  335  state for at least 65 years on or before July 1, 1994. All
  336  nursing home beds must not be available to the public but must
  337  be for the exclusive use of the community residents.
  338         (c)(d) For an inmate health care facility built by or for
  339  the exclusive use of the Department of Corrections as provided
  340  in chapter 945. This exemption expires when such facility is
  341  converted to other uses.
  342         (d)(e) For mobile surgical facilities and related health
  343  care services provided under contract with the Department of
  344  Corrections or a private correctional facility operating
  345  pursuant to chapter 957.
  346         (e)(f) For the addition of nursing home beds licensed under
  347  chapter 400 in a number not exceeding 30 total beds or 25
  348  percent of the number of beds licensed in the facility being
  349  replaced under paragraph (2)(b), paragraph (2)(c), or paragraph
  350  (j) (p), whichever is less.
  351         (f)(g) For state veterans’ nursing homes operated by or on
  352  behalf of the Florida Department of Veterans’ Affairs in
  353  accordance with part II of chapter 296 for which at least 50
  354  percent of the construction cost is federally funded and for
  355  which the Federal Government pays a per diem rate not to exceed
  356  one-half of the cost of the veterans’ care in such state nursing
  357  homes. These beds shall not be included in the nursing home bed
  358  inventory.
  359         (g)(h) For combination within one nursing home facility of
  360  the beds or services authorized by two or more certificates of
  361  need issued in the same planning subdistrict. An exemption
  362  granted under this paragraph shall extend the validity period of
  363  the certificates of need to be consolidated by the length of the
  364  period beginning upon submission of the exemption request and
  365  ending with issuance of the exemption. The longest validity
  366  period among the certificates shall be applicable to each of the
  367  combined certificates.
  368         (h)(i) For division into two or more nursing home
  369  facilities of beds or services authorized by one certificate of
  370  need issued in the same planning subdistrict. An exemption
  371  granted under this paragraph shall extend the validity period of
  372  the certificate of need to be divided by the length of the
  373  period beginning upon submission of the exemption request and
  374  ending with issuance of the exemption.
  375         (j)For the addition of hospital beds licensed under
  376  chapter 395 for comprehensive rehabilitation in a number that
  377  may not exceed 10 total beds or 10 percent of the licensed
  378  capacity, whichever is greater.
  379         1.In addition to any other documentation otherwise
  380  required by the agency, a request for exemption submitted under
  381  this paragraph must:
  382         a.Certify that the prior 12-month average occupancy rate
  383  for the licensed beds being expanded meets or exceeds 80
  384  percent.
  385         b.Certify that the beds have been licensed and operational
  386  for at least 12 months.
  387         2.The timeframes and monitoring process specified in s.
  388  408.040(2)(a)-(c) apply to any exemption issued under this
  389  paragraph.
  390         3.The agency shall count beds authorized under this
  391  paragraph as approved beds in the published inventory of
  392  hospital beds until the beds are licensed.
  393         (i)(k) For the addition of nursing home beds licensed under
  394  chapter 400 in a number not exceeding 10 total beds or 10
  395  percent of the number of beds licensed in the facility being
  396  expanded, whichever is greater; or, for the addition of nursing
  397  home beds licensed under chapter 400 at a facility that has been
  398  designated as a Gold Seal nursing home under s. 400.235 in a
  399  number not exceeding 20 total beds or 10 percent of the number
  400  of licensed beds in the facility being expanded, whichever is
  401  greater.
  402         1. In addition to any other documentation required by the
  403  agency, a request for exemption submitted under this paragraph
  404  must certify that:
  405         a. The facility has not had any class I or class II
  406  deficiencies within the 30 months preceding the request.
  407         b. The prior 12-month average occupancy rate for the
  408  nursing home beds at the facility meets or exceeds 94 percent.
  409         c. Any beds authorized for the facility under this
  410  paragraph before the date of the current request for an
  411  exemption have been licensed and operational for at least 12
  412  months.
  413         2. The timeframes and monitoring process specified in s.
  414  408.040(2)(a)-(c) apply to any exemption issued under this
  415  paragraph.
  416         3. The agency shall count beds authorized under this
  417  paragraph as approved beds in the published inventory of nursing
  418  home beds until the beds are licensed.
  419         (l)For the establishment of:
  420         1.A Level II neonatal intensive care unit with at least 10
  421  beds, upon documentation to the agency that the applicant
  422  hospital had a minimum of 1,500 births during the previous 12
  423  months;
  424         2.A Level III neonatal intensive care unit with at least
  425  15 beds, upon documentation to the agency that the applicant
  426  hospital has a Level II neonatal intensive care unit of at least
  427  10 beds and had a minimum of 3,500 births during the previous 12
  428  months; or
  429         3.A Level III neonatal intensive care unit with at least 5
  430  beds, upon documentation to the agency that the applicant
  431  hospital is a verified trauma center pursuant to s.
  432  395.4001(14), and has a Level II neonatal intensive care unit,
  433  
  434  if the applicant demonstrates that it meets the requirements for
  435  quality of care, nurse staffing, physician staffing, physical
  436  plant, equipment, emergency transportation, and data reporting
  437  found in agency certificate-of-need rules for Level II and Level
  438  III neonatal intensive care units and if the applicant commits
  439  to the provision of services to Medicaid and charity patients at
  440  a level equal to or greater than the district average. Such a
  441  commitment is subject to s. 408.040.
  442         (m)1.For the provision of adult open-heart services in a
  443  hospital located within the boundaries of a health service
  444  planning district, as defined in s. 408.032(5), which has
  445  experienced an annual net out-migration of at least 600 open
  446  heart-surgery cases for 3 consecutive years according to the
  447  most recent data reported to the agency, and the district’s
  448  population per licensed and operational open-heart programs
  449  exceeds the state average of population per licensed and
  450  operational open-heart programs by at least 25 percent. All
  451  hospitals within a health service planning district which meet
  452  the criteria reference in sub-subparagraphs 2.a.-h. shall be
  453  eligible for this exemption on July 1, 2004, and shall receive
  454  the exemption upon filing for it and subject to the following:
  455         a.A hospital that has received a notice of intent to grant
  456  a certificate of need or a final order of the agency granting a
  457  certificate of need for the establishment of an open-heart
  458  surgery program is entitled to receive a letter of exemption for
  459  the establishment of an adult open-heart-surgery program upon
  460  filing a request for exemption and complying with the criteria
  461  enumerated in sub-subparagraphs 2.a.-h., and is entitled to
  462  immediately commence operation of the program.
  463         b.An otherwise eligible hospital that has not received a
  464  notice of intent to grant a certificate of need or a final order
  465  of the agency granting a certificate of need for the
  466  establishment of an open-heart-surgery program is entitled to
  467  immediately receive a letter of exemption for the establishment
  468  of an adult open-heart-surgery program upon filing a request for
  469  exemption and complying with the criteria enumerated in sub
  470  subparagraphs 2.a.-h., but is not entitled to commence operation
  471  of its program until December 31, 2006.
  472         2.A hospital shall be exempt from the certificate-of-need
  473  review for the establishment of an open-heart-surgery program
  474  when the application for exemption submitted under this
  475  paragraph complies with the following criteria:
  476         a.The applicant must certify that it will meet and
  477  continuously maintain the minimum licensure requirements adopted
  478  by the agency governing adult open-heart programs, including the
  479  most current guidelines of the American College of Cardiology
  480  and American Heart Association Guidelines for Adult Open Heart
  481  Programs.
  482         b.The applicant must certify that it will maintain
  483  sufficient appropriate equipment and health personnel to ensure
  484  quality and safety.
  485         c.The applicant must certify that it will maintain
  486  appropriate times of operation and protocols to ensure
  487  availability and appropriate referrals in the event of
  488  emergencies.
  489         d.The applicant can demonstrate that it has discharged at
  490  least 300 inpatients with a principal diagnosis of ischemic
  491  heart disease for the most recent 12-month period as reported to
  492  the agency.
  493         e.The applicant is a general acute care hospital that is
  494  in operation for 3 years or more.
  495         f.The applicant is performing more than 300 diagnostic
  496  cardiac catheterization procedures per year, combined inpatient
  497  and outpatient.
  498         g.The applicant’s payor mix at a minimum reflects the
  499  community average for Medicaid, charity care, and self-pay
  500  patients or the applicant must certify that it will provide a
  501  minimum of 5 percent of Medicaid, charity care, and self-pay to
  502  open-heart-surgery patients.
  503         h.If the applicant fails to meet the established criteria
  504  for open-heart programs or fails to reach 300 surgeries per year
  505  by the end of its third year of operation, it must show cause
  506  why its exemption should not be revoked.
  507         3.By December 31, 2004, and annually thereafter, the
  508  agency shall submit a report to the Legislature providing
  509  information concerning the number of requests for exemption it
  510  has received under this paragraph during the calendar year and
  511  the number of exemptions it has granted or denied during the
  512  calendar year.
  513         (n)For the provision of percutaneous coronary intervention
  514  for patients presenting with emergency myocardial infarctions in
  515  a hospital without an approved adult open-heart-surgery program.
  516  In addition to any other documentation required by the agency, a
  517  request for an exemption submitted under this paragraph must
  518  comply with the following:
  519         1.The applicant must certify that it will meet and
  520  continuously maintain the requirements adopted by the agency for
  521  the provision of these services. These licensure requirements
  522  shall be adopted by rule and must be consistent with the
  523  guidelines published by the American College of Cardiology and
  524  the American Heart Association for the provision of percutaneous
  525  coronary interventions in hospitals without adult open-heart
  526  services. At a minimum, the rules must require the following:
  527         a.Cardiologists must be experienced interventionalists who
  528  have performed a minimum of 75 interventions within the previous
  529  12 months.
  530         b.The hospital must provide a minimum of 36 emergency
  531  interventions annually in order to continue to provide the
  532  service.
  533         c.The hospital must offer sufficient physician, nursing,
  534  and laboratory staff to provide the services 24 hours a day, 7
  535  days a week.
  536         d.Nursing and technical staff must have demonstrated
  537  experience in handling acutely ill patients requiring
  538  intervention based on previous experience in dedicated
  539  interventional laboratories or surgical centers.
  540         e.Cardiac care nursing staff must be adept in hemodynamic
  541  monitoring and Intra-aortic Balloon Pump (IABP) management.
  542         f.Formalized written transfer agreements must be developed
  543  with a hospital with an adult open-heart-surgery program, and
  544  written transport protocols must be in place to ensure safe and
  545  efficient transfer of a patient within 60 minutes. Transfer and
  546  transport agreements must be reviewed and tested, with
  547  appropriate documentation maintained at least every 3 months.
  548  However, a hospital located more than 100 road miles from the
  549  closest Level II adult cardiovascular services program does not
  550  need to meet the 60-minute transfer time protocol if the
  551  hospital demonstrates that it has a formalized, written transfer
  552  agreement with a hospital that has a Level II program. The
  553  agreement must include written transport protocols that ensure
  554  the safe and efficient transfer of a patient, taking into
  555  consideration the patient’s clinical and physical
  556  characteristics, road and weather conditions, and viability of
  557  ground and air ambulance service to transfer the patient.
  558         g.Hospitals implementing the service must first undertake
  559  a training program of 3 to 6 months’ duration, which includes
  560  establishing standards and testing logistics, creating quality
  561  assessment and error management practices, and formalizing
  562  patient-selection criteria.
  563         2.The applicant must certify that it will use at all times
  564  the patient-selection criteria for the performance of primary
  565  angioplasty at hospitals without adult open-heart-surgery
  566  programs issued by the American College of Cardiology and the
  567  American Heart Association. At a minimum, these criteria would
  568  provide for the following:
  569         a.Avoidance of interventions in hemodynamically stable
  570  patients who have identified symptoms or medical histories.
  571         b.Transfer of patients who have a history of coronary
  572  disease and clinical presentation of hemodynamic instability.
  573         3.The applicant must agree to submit a quarterly report to
  574  the agency detailing patient characteristics, treatment, and
  575  outcomes for all patients receiving emergency percutaneous
  576  coronary interventions pursuant to this paragraph. This report
  577  must be submitted within 15 days after the close of each
  578  calendar quarter.
  579         4.The exemption provided by this paragraph does not apply
  580  unless the agency determines that the hospital has taken all
  581  necessary steps to be in compliance with all requirements of
  582  this paragraph, including the training program required under
  583  sub-subparagraph 1.g.
  584         5.Failure of the hospital to continuously comply with the
  585  requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2.
  586  and 3. will result in the immediate expiration of this
  587  exemption.
  588         6.Failure of the hospital to meet the volume requirements
  589  of sub-subparagraphs 1.a. and b. within 18 months after the
  590  program begins offering the service will result in the immediate
  591  expiration of the exemption.
  592  
  593  If the exemption for this service expires under subparagraph 5.
  594  or subparagraph 6., the agency may not grant another exemption
  595  for this service to the same hospital for 2 years and then only
  596  upon a showing that the hospital will remain in compliance with
  597  the requirements of this paragraph through a demonstration of
  598  corrections to the deficiencies that caused expiration of the
  599  exemption. Compliance with the requirements of this paragraph
  600  includes compliance with the rules adopted pursuant to this
  601  paragraph.
  602         (o)For the addition of mental health services or beds if
  603  the applicant commits to providing services to Medicaid or
  604  charity care patients at a level equal to or greater than the
  605  district average. Such a commitment is subject to s. 408.040.
  606         (j)(p) For replacement of a licensed nursing home on the
  607  same site, or within 5 miles of the same site if within the same
  608  subdistrict, if the number of licensed beds does not increase
  609  except as permitted under paragraph (e)(f).
  610         (k)(q) For consolidation or combination of licensed nursing
  611  homes or transfer of beds between licensed nursing homes within
  612  the same planning district, by nursing homes with any shared
  613  controlled interest within that planning district, if there is
  614  no increase in the planning district total number of nursing
  615  home beds and the site of the relocation is not more than 30
  616  miles from the original location.
  617         (l)(r) For beds in state mental health treatment facilities
  618  defined in s. 394.455 and state mental health forensic
  619  facilities operated under chapter 916.
  620         (m)(s) For beds in state developmental disabilities centers
  621  as defined in s. 393.063.
  622         (n)(t) For the establishment of a health care facility or
  623  project that meets all of the following criteria:
  624         1. The applicant was previously licensed within the past 21
  625  days as a health care facility or provider that is subject to
  626  subsection (1).
  627         2. The applicant failed to submit a renewal application and
  628  the license expired on or after January 1, 2015.
  629         3. The applicant does not have a license denial or
  630  revocation action pending with the agency at the time of the
  631  request.
  632         4. The applicant’s request is for the same service type,
  633  district, service area, and site for which the applicant was
  634  previously licensed.
  635         5. The applicant’s request, if applicable, includes the
  636  same number and type of beds as were previously licensed.
  637         6. The applicant agrees to the same conditions that were
  638  previously imposed on the certificate of need or on an exemption
  639  related to the applicant’s previously licensed health care
  640  facility or project.
  641         7. The applicant applies for initial licensure as required
  642  under s. 408.806 within 21 days after the agency approves the
  643  exemption request. If the applicant fails to apply in a timely
  644  manner, the exemption expires on the 22nd day following the
  645  agency’s approval of the exemption.
  646  
  647  Notwithstanding subparagraph 1., an applicant whose license
  648  expired between January 1, 2015, and the effective date of this
  649  act may apply for an exemption within 30 days of this act
  650  becoming law.
  651         (4) REQUESTS FOR EXEMPTION.—A request for exemption under
  652  subsection (3) may be made at any time and is not subject to the
  653  batching requirements of this section. The request shall be
  654  supported by such documentation as the agency requires by rule.
  655  The agency shall assess a fee of $250 for each request for
  656  exemption submitted under subsection (3).
  657         (5) NOTIFICATION.—Health care facilities and providers must
  658  provide to the agency notification of:
  659         (a) replacement of a health care facility when the proposed
  660  project site is located in the same district and on the existing
  661  site or within a 1-mile radius of the replaced health care
  662  facility, if the number and type of beds do not increase.
  663         (b)The termination of a health care service, upon 30 days’
  664  written notice to the agency.
  665         (c)The addition or delicensure of beds.
  666  
  667  Notification under this subsection may be made by electronic,
  668  facsimile, or written means at any time before the described
  669  action has been taken.
  670         Section 5. Section 408.037, Florida Statutes, is amended to
  671  read:
  672         408.037 Application content.—
  673         (1) Except as provided in subsection (2) for a general
  674  hospital, An application for a certificate of need must contain:
  675         (a) A detailed description of the proposed project and
  676  statement of its purpose and need in relation to the district
  677  health plan.
  678         (b) A statement of the financial resources needed by and
  679  available to the applicant to accomplish the proposed project.
  680  This statement must include:
  681         1. A complete listing of all capital projects, including
  682  new health facility development projects and health facility
  683  acquisitions applied for, pending, approved, or underway in any
  684  state at the time of application, regardless of whether or not
  685  that state has a certificate-of-need program or a capital
  686  expenditure review program pursuant to s. 1122 of the Social
  687  Security Act. The agency may, by rule, require less-detailed
  688  information from major health care providers. This listing must
  689  include the applicant’s actual or proposed financial commitment
  690  to those projects and an assessment of their impact on the
  691  applicant’s ability to provide the proposed project.
  692         2. A detailed listing of the needed capital expenditures,
  693  including sources of funds.
  694         3. A detailed financial projection, including a statement
  695  of the projected revenue and expenses for the first 2 years of
  696  operation after completion of the proposed project. This
  697  statement must include a detailed evaluation of the impact of
  698  the proposed project on the cost of other services provided by
  699  the applicant.
  700         (c) An audited financial statement of the applicant or the
  701  applicant’s parent corporation if audited financial statements
  702  of the applicant do not exist. In an application submitted by an
  703  existing health care facility, health maintenance organization,
  704  or hospice, financial condition documentation must include, but
  705  need not be limited to, a balance sheet and a profit-and-loss
  706  statement of the 2 previous fiscal years’ operation.
  707         (2)An application for a certificate of need for a general
  708  hospital must contain a detailed description of the proposed
  709  general hospital project and a statement of its purpose and the
  710  needs it will meet. The proposed project’s location, as well as
  711  its primary and secondary service areas, must be identified by
  712  zip code. Primary service area is defined as the zip codes from
  713  which the applicant projects that it will draw 75 percent of its
  714  discharges. Secondary service area is defined as the zip codes
  715  from which the applicant projects that it will draw its
  716  remaining discharges. If, subsequent to issuance of a final
  717  order approving the certificate of need, the proposed location
  718  of the general hospital changes or the primary service area
  719  materially changes, the agency shall revoke the certificate of
  720  need. However, if the agency determines that such changes are
  721  deemed to enhance access to hospital services in the service
  722  district, the agency may permit such changes to occur. A party
  723  participating in the administrative hearing regarding the
  724  issuance of the certificate of need for a general hospital has
  725  standing to participate in any subsequent proceeding regarding
  726  the revocation of the certificate of need for a hospital for
  727  which the location has changed or for which the primary service
  728  area has materially changed. In addition, the application for
  729  the certificate of need for a general hospital must include a
  730  statement of intent that, if approved by final order of the
  731  agency, the applicant shall within 120 days after issuance of
  732  the final order or, if there is an appeal of the final order,
  733  within 120 days after the issuance of the court’s mandate on
  734  appeal, furnish satisfactory proof of the applicant’s financial
  735  ability to operate. The agency shall establish documentation
  736  requirements, to be completed by each applicant, which show
  737  anticipated provider revenues and expenditures, the basis for
  738  financing the anticipated cash-flow requirements of the
  739  provider, and an applicant’s access to contingency financing. A
  740  party participating in the administrative hearing regarding the
  741  issuance of the certificate of need for a general hospital may
  742  provide written comments concerning the adequacy of the
  743  financial information provided, but such party does not have
  744  standing to participate in an administrative proceeding
  745  regarding proof of the applicant’s financial ability to operate.
  746  The agency may require a licensee to provide proof of financial
  747  ability to operate at any time if there is evidence of financial
  748  instability, including, but not limited to, unpaid expenses
  749  necessary for the basic operations of the provider.
  750         (2)(3) The applicant must certify that it will license and
  751  operate the health care facility. For an existing health care
  752  facility, the applicant must be the licenseholder of the
  753  facility.
  754         Section 6. Paragraphs (c) and (d) of subsection (3),
  755  paragraphs (b) and (c) of subsection (5), and paragraph (d) of
  756  subsection (6) of section 408.039, Florida Statutes, are amended
  757  to read:
  758         408.039 Review process.—The review process for certificates
  759  of need shall be as follows:
  760         (3) APPLICATION PROCESSING.—
  761         (c)Except for competing applicants, in order to be
  762  eligible to challenge the agency decision on a general hospital
  763  application under review pursuant to paragraph (5)(c), existing
  764  hospitals must submit a detailed written statement of opposition
  765  to the agency and to the applicant. The detailed written
  766  statement must be received by the agency and the applicant
  767  within 21 days after the general hospital application is deemed
  768  complete and made available to the public.
  769         (d)In those cases where a written statement of opposition
  770  has been timely filed regarding a certificate of need
  771  application for a general hospital, the applicant for the
  772  general hospital may submit a written response to the agency.
  773  Such response must be received by the agency within 10 days of
  774  the written statement due date.
  775         (5) ADMINISTRATIVE HEARINGS.—
  776         (b) Hearings shall be held in Tallahassee unless the
  777  administrative law judge determines that changing the location
  778  will facilitate the proceedings. The agency shall assign
  779  proceedings requiring hearings to the Division of Administrative
  780  Hearings of the Department of Management Services within 10 days
  781  after the time has expired for requesting a hearing. Except upon
  782  unanimous consent of the parties or upon the granting by the
  783  administrative law judge of a motion of continuance, hearings
  784  shall commence within 60 days after the administrative law judge
  785  has been assigned. For an application for a general hospital,
  786  administrative hearings shall commence within 6 months after the
  787  administrative law judge has been assigned, and a continuance
  788  may not be granted absent a finding of extraordinary
  789  circumstances by the administrative law judge. All parties,
  790  except the agency, shall bear their own expense of preparing a
  791  transcript. In any application for a certificate of need which
  792  is referred to the Division of Administrative Hearings for
  793  hearing, the administrative law judge shall complete and submit
  794  to the parties a recommended order as provided in ss. 120.569
  795  and 120.57. The recommended order shall be issued within 30 days
  796  after the receipt of the proposed recommended orders or the
  797  deadline for submission of such proposed recommended orders,
  798  whichever is earlier. The division shall adopt procedures for
  799  administrative hearings which shall maximize the use of
  800  stipulated facts and shall provide for the admission of prepared
  801  testimony.
  802         (c) In administrative proceedings challenging the issuance
  803  or denial of a certificate of need, only applicants considered
  804  by the agency in the same batching cycle are entitled to a
  805  comparative hearing on their applications. Existing health care
  806  facilities may initiate or intervene in an administrative
  807  hearing upon a showing that an established program will be
  808  substantially affected by the issuance of any certificate of
  809  need, whether reviewed under s. 408.036(1) or (2), to a
  810  competing proposed facility or program within the same district.
  811  With respect to an application for a general hospital, competing
  812  applicants and only those existing hospitals that submitted a
  813  detailed written statement of opposition to an application as
  814  provided in this paragraph may initiate or intervene in an
  815  administrative hearing. Such challenges to a general hospital
  816  application shall be limited in scope to the issues raised in
  817  the detailed written statement of opposition that was provided
  818  to the agency. The administrative law judge may, upon a motion
  819  showing good cause, expand the scope of the issues to be heard
  820  at the hearing. Such motion shall include substantial and
  821  detailed facts and reasons for failure to include such issues in
  822  the original written statement of opposition.
  823         (6) JUDICIAL REVIEW.—
  824         (d)The party appealing a final order that grants a general
  825  hospital certificate of need shall pay the appellee’s attorney’s
  826  fees and costs, in an amount up to $1 million, from the
  827  beginning of the original administrative action if the appealing
  828  party loses the appeal, subject to the following limitations and
  829  requirements:
  830         1.The party appealing a final order must post a bond in
  831  the amount of $1 million in order to maintain the appeal.
  832         2.Except as provided under s. 120.595(5), in no event
  833  shall the agency be held liable for any other party’s attorney’s
  834  fees or costs.
  835         Section 7. Subsection (1) of section 408.043, Florida
  836  Statutes, is amended to read:
  837         408.043 Special provisions.—
  838         (1)OSTEOPATHIC ACUTE CARE HOSPITALS.—When an application
  839  is made for a certificate of need to construct or to expand an
  840  osteopathic acute care hospital, the need for such hospital
  841  shall be determined on the basis of the need for and
  842  availability of osteopathic services and osteopathic acute care
  843  hospitals in the district. When a prior certificate of need to
  844  establish an osteopathic acute care hospital has been issued in
  845  a district, and the facility is no longer used for that purpose,
  846  the agency may continue to count such facility and beds as an
  847  existing osteopathic facility in any subsequent application for
  848  construction of an osteopathic acute care hospital.
  849         Section 8. Paragraph (f) of subsection (1) of section
  850  395.1055, Florida Statutes, is amended to read:
  851         395.1055 Rules and enforcement.—
  852         (1) The agency shall adopt rules pursuant to ss. 120.536(1)
  853  and 120.54 to implement the provisions of this part, which shall
  854  include reasonable and fair minimum standards for ensuring that:
  855         (f) All hospitals providing pediatric cardiac
  856  catheterization, pediatric open-heart surgery, organ
  857  transplantation, neonatal intensive care services, psychiatric
  858  services, or comprehensive medical rehabilitation meet the
  859  minimum licensure requirements adopted by the agency. Such
  860  licensure requirements shall include quality of care, nurse
  861  staffing, physician staffing, physical plant, equipment,
  862  emergency transportation, and data reporting standards submit
  863  such data as necessary to conduct certificate-of-need reviews
  864  required under part I of chapter 408. Such data shall include,
  865  but shall not be limited to, patient origin data, hospital
  866  utilization data, type of service reporting, and facility
  867  staffing data. The agency may not collect data that identifies
  868  or could disclose the identity of individual patients. The
  869  agency shall utilize existing uniform statewide data sources
  870  when available and shall minimize reporting costs to hospitals.
  871         Section 9. Section 395.6025, Florida Statutes, is repealed.
  872         Section 10. Subsection (1) of section 395.603, Florida
  873  Statutes, is amended to read:
  874         395.603 Deactivation of general hospital beds; rural
  875  hospital impact statement.—
  876         (1) The agency shall establish, by rule, a process by which
  877  a rural hospital, as defined in s. 395.602, that seeks licensure
  878  as a rural primary care hospital or as an emergency care
  879  hospital, or becomes a certified rural health clinic as defined
  880  in Pub. L. No. 95-210, or becomes a primary care program such as
  881  a county health department, community health center, or other
  882  similar outpatient program that provides preventive and curative
  883  services, may deactivate general hospital beds. Rural primary
  884  care hospitals and emergency care hospitals shall maintain the
  885  number of actively licensed general hospital beds necessary for
  886  the facility to be certified for Medicare reimbursement.
  887  Hospitals that discontinue inpatient care to become rural health
  888  care clinics or primary care programs shall deactivate all
  889  licensed general hospital beds. All hospitals, clinics, and
  890  programs with inactive beds shall provide 24-hour emergency
  891  medical care by staffing an emergency room. Providers with
  892  inactive beds shall be subject to the criteria in s. 395.1041.
  893  The agency shall specify in rule requirements for making 24-hour
  894  emergency care available. Inactive general hospital beds shall
  895  be included in the acute care bed inventory, maintained by the
  896  agency for certificate-of-need purposes, for 10 years from the
  897  date of deactivation of the beds. After 10 years have elapsed,
  898  inactive beds shall be excluded from the inventory. The agency
  899  shall, at the request of the licensee, reactivate the inactive
  900  general beds upon a showing by the licensee that licensure
  901  requirements for the inactive general beds are met.
  902         Section 11. Subsection (1) of section 395.604, Florida
  903  Statutes, is amended to read:
  904         395.604 Other rural hospital programs.—
  905         (1) The agency may license rural primary care hospitals
  906  subject to federal approval for participation in the Medicare
  907  and Medicaid programs. Rural primary care hospitals shall be
  908  treated in the same manner as emergency care hospitals and rural
  909  hospitals with respect to ss. 395.605(2)-(7)(a) 395.605(2)
  910  (8)(a), 408.033(2)(b)3., and 408.038.
  911         Section 12. Subsection (5) of section 395.605, Florida
  912  Statutes, is amended to read:
  913         395.605 Emergency care hospitals.—
  914         (5)Rural hospitals that make application under the
  915  certificate-of-need program to be licensed as emergency care
  916  hospitals shall receive expedited review as defined in s.
  917  408.032. Emergency care hospitals seeking relicensure as acute
  918  care general hospitals shall also receive expedited review.
  919         Section 13. Paragraph (b) of subsection (1) of section
  920  408.033, Florida Statutes, is amended to read:
  921         408.033 Local and state health planning.—
  922         (1) LOCAL HEALTH COUNCILS.—
  923         (b) Each local health council may:
  924         1. Develop a district area health plan that permits each
  925  local health council to develop strategies and set priorities
  926  for implementation based on its unique local health needs.
  927         2. Advise the agency on health care issues and resource
  928  allocations.
  929         3. Promote public awareness of community health needs,
  930  emphasizing health promotion and cost-effective health service
  931  selection.
  932         4. Collect data and conduct analyses and studies related to
  933  health care needs of the district, including the needs of
  934  medically indigent persons, and assist the agency and other
  935  state agencies in carrying out data collection activities that
  936  relate to the functions in this subsection.
  937         5. Monitor the onsite construction progress, if any, of
  938  certificate-of-need approved projects and report council
  939  findings to the agency on forms provided by the agency.
  940         6. Advise and assist any regional planning councils within
  941  each district that have elected to address health issues in
  942  their strategic regional policy plans with the development of
  943  the health element of the plans to address the health goals and
  944  policies in the State Comprehensive Plan.
  945         7. Advise and assist local governments within each district
  946  on the development of an optional health plan element of the
  947  comprehensive plan provided in chapter 163, to assure
  948  compatibility with the health goals and policies in the State
  949  Comprehensive Plan and district health plan. To facilitate the
  950  implementation of this section, the local health council shall
  951  annually provide the local governments in its service area, upon
  952  request, with:
  953         a. A copy and appropriate updates of the district health
  954  plan;
  955         b. A report of health facility hospital and nursing home
  956  utilization statistics for facilities within the local
  957  government jurisdiction; and
  958         c. Applicable agency rules and calculated need
  959  methodologies for health facilities and services regulated under
  960  s. 408.034 for the district served by the local health council.
  961         8. Monitor and evaluate the adequacy, appropriateness, and
  962  effectiveness, within the district, of local, state, federal,
  963  and private funds distributed to meet the needs of the medically
  964  indigent and other underserved population groups.
  965         9. In conjunction with the Department of Health, plan for
  966  services at the local level for persons infected with the human
  967  immunodeficiency virus.
  968         10. Provide technical assistance to encourage and support
  969  activities by providers, purchasers, consumers, and local,
  970  regional, and state agencies in meeting the health care goals,
  971  objectives, and policies adopted by the local health council.
  972         11. Provide the agency with data required by rule for the
  973  review of certificate-of-need applications and the projection of
  974  need for health services and facilities in the district.
  975         Section 14. Subsections (2) and (4) of section 408.0361,
  976  Florida Statutes, are amended to read:
  977         408.0361 Cardiovascular services and burn unit licensure.—
  978         (2) Each provider of adult cardiovascular services or
  979  operator of a burn unit shall comply with rules adopted by the
  980  agency that establish licensure standards that govern the
  981  provision of adult cardiovascular services or the operation of a
  982  burn unit. Such rules shall consider, at a minimum, staffing,
  983  equipment, physical plant, operating protocols, the provision of
  984  services to Medicaid and charity care patients, accreditation,
  985  licensure period and fees, and enforcement of minimum standards.
  986  The certificate-of-need rules for adult cardiovascular services
  987  and burn units in effect on June 30, 2004, are authorized
  988  pursuant to this subsection and shall remain in effect and shall
  989  be enforceable by the agency until the licensure rules are
  990  adopted. Existing providers and any provider with a notice of
  991  intent to grant a certificate of need or a final order of the
  992  agency granting a certificate of need for adult cardiovascular
  993  services or burn units shall be considered grandfathered and
  994  receive a license for their programs effective on the effective
  995  date of this act. The grandfathered licensure shall be for at
  996  least 3 years or until July 1, 2008, whichever is longer, but
  997  shall be required to meet licensure standards applicable to
  998  existing programs for every subsequent licensure period.
  999         (4)In order to ensure continuity of available services,
 1000  the holder of a certificate of need for a newly licensed
 1001  hospital that meets the requirements of this subsection may
 1002  apply for and shall be granted Level I program status regardless
 1003  of whether rules relating to Level I programs have been adopted.
 1004  To qualify for a Level I program under this subsection, a
 1005  hospital seeking a Level I program must be a newly licensed
 1006  hospital established pursuant to a certificate of need in a
 1007  physical location previously licensed and operated as a
 1008  hospital, the former hospital must have provided a minimum of
 1009  300 adult inpatient and outpatient diagnostic cardiac
 1010  catheterizations for the most recent 12-month period as reported
 1011  to the agency, and the newly licensed hospital must have a
 1012  formalized, written transfer agreement with a hospital that has
 1013  a Level II program, including written transport protocols to
 1014  ensure safe and efficient transfer of a patient within 60
 1015  minutes. A hospital meeting the requirements of this subsection
 1016  may apply for certification of Level I program status before
 1017  taking possession of the physical location of the former
 1018  hospital, and the effective date of Level I program status shall
 1019  be concurrent with the effective date of the newly issued
 1020  hospital license.
 1021         Section 15. This act shall take effect July 1, 2018.