Florida Senate - 2025 SB 596
By Senator Leek
7-00346A-25 2025596__
1 A bill to be entitled
2 An act relating to cardiac services providers;
3 amending s. 395.1055, F.S.; revising requirements for
4 licensure of Level I and Level II adult cardiovascular
5 programs; requiring the Agency for Health Care
6 Administration to update specified rules as new
7 applicable industry standards and guidelines are
8 published; providing an effective date.
9
10 Be It Enacted by the Legislature of the State of Florida:
11
12 Section 1. Subsections (18) and (19) of section 395.1055,
13 Florida Statutes, are amended to read:
14 395.1055 Rules and enforcement.—
15 (18)(a) In establishing rules for adult cardiovascular
16 services, The agency shall grant licensure include provisions
17 that allow for:
18 (a) the establishment of two hospital program licensure
19 levels, a Level I program that authorizes the performance of
20 adult percutaneous cardiac intervention without onsite cardiac
21 surgery, including rotational or other atherectomy devices,
22 electrophysiology, and treatment of chronic total occlusions,
23 and a Level II program that authorizes the performance of
24 percutaneous cardiac intervention with onsite cardiac surgery.
25 (b)1. For A hospital seeking licensure as a Level I program
26 must:, demonstration that, for the most recent 12-month period
27 as reported to the agency, the hospital has provided a minimum
28 of 300 adult inpatient and outpatient diagnostic cardiac
29 catheterizations or, for the most recent 12-month period, has
30 discharged or transferred at least 300 patients with the
31 principal diagnosis of ischemic heart disease and that it has
32 1. Have a formalized, written transfer agreement with a
33 hospital that has a Level II program, including written
34 transport protocols to ensure safe and efficient transfer of a
35 patient within 60 minutes.
36 2.a. A hospital located more than 100 road miles from the
37 closest Level II adult cardiovascular services program is not
38 required to meet the diagnostic cardiac catheterization volume
39 and ischemic heart disease diagnosis volume requirements in
40 subparagraph 1. if the hospital demonstrates that it has, for
41 the most recent 12-month period as reported to the agency,
42 provided a minimum of 100 adult inpatient and outpatient
43 diagnostic cardiac catheterizations or that, for the most recent
44 12-month period, it has discharged or transferred at least 300
45 patients with the principal diagnosis of ischemic heart disease.
46 b. For a hospital located more than 100 road miles from the
47 closest Level II adult cardiovascular services program, have
48 does not need to meet the 60-minute transfer time protocol
49 requirement in subparagraph 1. if the hospital demonstrates that
50 it has a formalized, written transfer agreement with a hospital
51 that has a Level II program. The agreement must include written
52 transport protocols to ensure the safe and efficient transfer of
53 a patient, taking into consideration the patient’s clinical and
54 physical characteristics, road and weather conditions, and
55 viability of ground and air ambulance service to transfer the
56 patient.
57 3. At a minimum, the rules for adult cardiovascular
58 services must require nursing and technical staff to have
59 demonstrated experience in handling acutely ill patients
60 requiring intervention, based on the staff member’s previous
61 experience in dedicated cardiac interventional laboratories or
62 surgical centers. If a staff member’s previous experience is in
63 a dedicated cardiac interventional laboratory at a hospital that
64 does not have an approved adult open heart surgery program, the
65 staff member’s previous experience qualifies only if, at the
66 time the staff member acquired his or her experience, the
67 dedicated cardiac interventional laboratory:
68 a. Had an annual volume of 500 or more percutaneous cardiac
69 intervention procedures.
70 b. Achieved a demonstrated success rate of 95 percent or
71 greater for percutaneous cardiac intervention procedures.
72 c. Experienced a complication rate of less than 5 percent
73 for percutaneous cardiac intervention procedures.
74 d. Performed diverse cardiac procedures, including, but not
75 limited to, balloon angioplasty and stenting, rotational
76 atherectomy, cutting balloon atheroma remodeling, and procedures
77 relating to left ventricular support capability.
78 (c) For A hospital seeking licensure as a Level II program
79 must demonstrate, demonstration that, for the most recent 12
80 month period as reported to the agency, the hospital has
81 performed a minimum of 1,100 adult inpatient and outpatient
82 cardiac catheterizations, of which at least 400 must be
83 therapeutic catheterizations, or, for the most recent 12-month
84 period, has discharged at least 800 patients with the principal
85 diagnosis of ischemic heart disease.
86 (d) As a condition of licensure as a Level I or Level II
87 program, a hospital must demonstrate all of the following:
88 1. Compliance with the most recent guidelines of the
89 American College of Cardiology, and the American Heart
90 Association, the Society for Cardiovascular Angiography and
91 Interventions, and, for hospitals providing electrophysiology
92 services, the Heart Rhythm Society guidelines for staffing,
93 physician training and experience, operating procedures,
94 equipment, physical plant, and patient selection criteria, to
95 ensure patient quality and safety.
96 2.(e) The establishment of appropriate hours of operation
97 and protocols to ensure availability and timely referral in the
98 event of emergencies.
99 3.(f) The demonstration of A plan to provide services to
100 Medicaid and charity care patients.
101 4.(g) For a hospital licensed as a for adult diagnostic
102 cardiac catheterization that provides Level I or Level II
103 program for adult cardiovascular services, demonstration that
104 the hospital is participating in the American College of
105 Cardiology’s National Cardiovascular Data Registry or the
106 American Heart Association’s Get with the Guidelines–Coronary
107 Artery Disease registry and documentation of an ongoing quality
108 improvement plan ensuring that the licensed cardiac program
109 meets or exceeds national quality and outcome benchmarks
110 reported by the registry in which the hospital participates. A
111 hospital licensed for Level II adult cardiovascular services
112 must also participate in the clinical outcome reporting systems
113 operated by the Society for Thoracic Surgeons.
114 (19) The agency may adopt rules to administer the
115 requirements of part II of chapter 408 and shall update such
116 rules as new applicable industry standards and guidelines are
117 published.
118 Section 2. This act shall take effect October 1, 2025.