Florida Senate - 2018 COMMITTEE AMENDMENT
Bill No. SB 622
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:
(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
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
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
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
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
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: