Read the full stored bill text
Florida Senate
-
2026
SB 396
By
Senator Leek
7-00339-26 2026396__
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
mus
t d
emonstrate
,
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
Intervention
s,
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, 2026.