Florida Senate - 2018                        COMMITTEE AMENDMENT
       Bill No. SB 622
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       Appropriations Subcommittee on Health and Human Services
       (Grimsley) recommended the following:
    1         Senate Amendment (with directory amendment)
    3         Delete line 1791
    4  and insert:
    5         (m)1.For the provision of adult open-heart services in a
    6  hospital located within the boundaries of a health service
    7  planning district, as defined in s. 408.032(5), which has
    8  experienced an annual net out-migration of at least 600 open
    9  heart surgery cases for 3 consecutive years according to the
   10  most recent data reported to the agency, and the districts
   11  population per licensed and operational open-heart programs
   12  exceeds the state average of population per licensed and
   13  operational open-heart programs exceeds the state average of
   14  population per licensed and operational open-heart programs by
   15  at least 25 percent. All hospitals within a health service
   16  planning district which meet the criteria reference in sub
   17  subparagraphs 2.a.-h. shall be eligible for this exemption on
   18  July 1, 2004, and shall receive the exemption upon filing for it
   19  and subject to the following:
   20         a.A hospital that has received a notice of intent to grant
   21  a certificate of need or a final order of the agency granting a
   22  certificate of need for the establishment of an open-heart
   23  surgery program is entitled to receive a letter of exemption for
   24  the establishment of an adult open-heart-surgery program upon
   25  filing a request for exemption and complying with the criteria
   26  enumerated in sub-subparagraphs 2.a.-h., and is entitled to
   27  immediately commence operation of the program.
   28         b. An otherwise eligible hospital that has not received a
   29  notice of intent to grant a certificate of need or a final order
   30  of the agency granting a certificate of need for the
   31  establishment of an open-heart-surgery program is entitled to
   32  immediately receive a letter of exemption for the establishment
   33  of an adult open-heart-surgery program upon filing a request for
   34  exemption and complying with the criteria enumerated in sub
   35  subparagraphs 2.a.-h., but is not entitled to commence operation
   36  of its program until December 31, 2006.
   37         2. A hospital shall be exempt from the certificate-of-need
   38  review for the establishment of an open-heart-surgery program
   39  when the application for exemption submitted under this
   40  paragraph complies with the following criteria:
   41         a. The applicant must certify that it will meet and
   42  continuously maintain the minimum licensure requirements adopted
   43  by the agency governing adult open-heart programs, including the
   44  most current guidelines of the American College of Cardiology
   45  and American Heart Association Guidelines for Adult Open Heart
   46  Programs.
   47         b. The applicant must certify that it will maintain
   48  sufficient appropriate equipment and health personnel to ensure
   49  quality and safety.
   50         c. The applicant must certify that it will maintain
   51  appropriate times of operation and protocols to ensure
   52  availability and appropriate referrals in the event of
   53  emergencies.
   54         d. The applicant can demonstrate that it has discharged at
   55  least 300 inpatients with a principal diagnosis of ischemic
   56  heart disease for the most recent 12-month period as reported to
   57  the agency.
   58         e. The applicant is a general acute care hospital that is
   59  in operation for 3 years or more.
   60         f. The applicant is performing more than 300 diagnostic
   61  cardiac catheterization procedures per year, combined inpatient
   62  and outpatient.
   63         g. The applicant’s payor mix at a minimum reflects the
   64  community average for Medicaid, charity care, and self-pay
   65  patients or the applicant must certify that it will provide a
   66  minimum of 5 percent of Medicaid, charity care, and self-pay to
   67  open-heart-surgery patients.
   68         h. If the applicant fails to meet the established criteria
   69  for open-heart programs or fails to reach 300 surgeries per year
   70  by the end of its third year of operation, it must show cause
   71  why its exemption should not be revoked.
   72         3. By December 31, 2004, and annually thereafter, the
   73  agency shall submit a report to the Legislature providing
   74  information concerning the number of requests for exemption it
   75  has received under this paragraph during the calendar year and
   76  the number of exemptions it has granted or denied during the
   77  calendar year.
   78         (n) For the provision of percutaneous coronary intervention
   79  for patients presenting with emergency myocardial infarctions in
   80  a hospital without an approved adult open-heart-surgery program.
   81  In addition to any other documentation required by the agency, a
   82  request for an exemption submitted under this paragraph must
   83  comply with the following:
   84         1. The applicant must certify that it will meet and
   85  continuously maintain the requirements adopted by the agency for
   86  the provision of these services. These licensure requirements
   87  shall be adopted by rule and must be consistent with the
   88  guidelines published by the American College of Cardiology and
   89  the American Heart Association for the provision of percutaneous
   90  coronary interventions in hospitals without adult open-heart
   91  services. At a minimum, the rules must require the following:
   92         a. Cardiologists must be experienced interventionalists who
   93  have performed a minimum of 75 interventions within the previous
   94  12 months.
   95         b. The hospital must provide a minimum of 36 emergency
   96  interventions annually in order to continue to provide the
   97  service.
   98         c. The hospital must offer sufficient physician, nursing,
   99  and laboratory staff to provide the services 24 hours a day, 7
  100  days a week.
  101         d. Nursing and technical staff must have demonstrated
  102  experience in handling acutely ill patients requiring
  103  intervention based on previous experience in dedicated
  104  interventional laboratories or surgical centers.
  105         e. Cardiac care nursing staff must be adept in hemodynamic
  106  monitoring and Intra-aortic Balloon Pump (IABP) management.
  107         f. Formalized written transfer agreements must be developed
  108  with a hospital with an adult open-heart-surgery program, and
  109  written transport protocols must be in place to ensure safe and
  110  efficient transfer of a patient within 60 minutes. Transfer and
  111  transport agreements must be reviewed and tested, with
  112  appropriate documentation maintained at least every 3 months.
  113  However, a hospital located more than 100 road miles from the
  114  closest Level II adult cardiovascular services program does not
  115  need to meet the 60-minute transfer time protocol if the
  116  hospital demonstrates that it has a formalized, written transfer
  117  agreement with a hospital that has a Level II program. The
  118  agreement must include written transport protocols that ensure
  119  the safe and efficient transfer of a patient, taking into
  120  consideration the patient’s clinical and physical
  121  characteristics, road and weather conditions, and viability of
  122  ground and air ambulance service to transfer the patient.
  123         g. Hospitals implementing the service must first undertake
  124  a training program of 3 to 6 months’ duration, which includes
  125  establishing standards and testing logistics, creating quality
  126  assessment and error management practices, and formalizing
  127  patient-selection criteria.
  128         2. The applicant must certify that it will use at all times
  129  the patient-selection criteria for the performance of primary
  130  angioplasty at hospitals without adult open-heart-surgery
  131  programs issued by the American College of Cardiology and the
  132  American Heart Association. At a minimum, these criteria would
  133  provide for the following:
  134         a. Avoidance of interventions in hemodynamically stable
  135  patients who have identified symptoms or medical histories.
  136         b. Transfer of patients who have a history of coronary
  137  disease and clinical presentation of hemodynamic instability.
  138         3. The applicant must agree to submit a quarterly report to
  139  the agency detailing patient characteristics, treatment, and
  140  outcomes for all patients receiving emergency percutaneous
  141  coronary interventions pursuant to this paragraph. This report
  142  must be submitted within 15 days after the close of each
  143  calendar quarter.
  144         4. The exemption provided by this paragraph does not apply
  145  unless the agency determines that the hospital has taken all
  146  necessary steps to be in compliance with all requirements of
  147  this paragraph, including the training program required under
  148  sub-subparagraph 1.g.
  149         5. Failure of the hospital to continuously comply with the
  150  requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2.
  151  and 3. will result in the immediate expiration of this
  152  exemption.
  153         6. Failure of the hospital to meet the volume requirements
  154  of sub-subparagraphs 1.a. and b. within 18 months after the
  155  program begins offering the service will result in the immediate
  156  expiration of the exemption.
  158  If the exemption for this service expires under subparagraph 5.
  159  or subparagraph 6., the agency may not grant another exemption
  160  for this service to the same hospital for 2 years and then only
  161  upon a showing that the hospital will remain in compliance with
  162  the requirements of this paragraph through a demonstration of
  163  corrections to the deficiencies that caused expiration of the
  164  exemption. Compliance with the requirements of this paragraph
  165  includes compliance with the rules adopted pursuant to this
  166  paragraph.
  167         (m)(p) For replacement of a licensed nursing home on the
  169  ====== D I R E C T O R Y  C L A U S E  A M E N D M E N T ======
  170  And the directory clause is amended as follows:
  171         Delete lines 1780 - 1783
  172  and insert:
  173         Section 60. Present paragraphs (f) through (l) of
  174  subsection (3) of section 408.036, Florida Statutes, are
  175  redesignated as paragraphs (e) through (k), respectively,
  176  present paragraphs (o) through (t) of that subsection are
  177  redesignated as paragraphs (l) through (q), respectively, and
  178  present paragraphs (e), (m), (n), and (p) of that subsection are
  179  amended, to read: