Florida Senate - 2016 SB 1518
By Senator Grimsley
21-01207-16 20161518__
1 A bill to be entitled
2 An act relating to adult cardiovascular services;
3 amending s. 408.0361, F.S.; expanding rulemaking
4 criteria for the Agency for Health Care Administration
5 for licensure of hospitals performing percutaneous
6 coronary intervention; deleting provisions relating to
7 newly licensed hospitals seeking a specified program
8 status; repealing s. 408.036(3)(m) and (n), F.S.,
9 relating to exemptions for certificate of need
10 projects subject to review relating to adult open
11 heart services in a hospital and percutaneous coronary
12 intervention; providing an effective date.
13
14 Be It Enacted by the Legislature of the State of Florida:
15
16 Section 1. Section 408.0361, Florida Statutes, is amended
17 to read:
18 408.0361 Cardiovascular services and burn unit licensure.—
19 (1) Each provider of diagnostic cardiac catheterization
20 services shall comply with rules adopted by the agency that
21 establish licensure standards governing the operation of adult
22 inpatient diagnostic cardiac catheterization programs. The rules
23 shall ensure that such programs:
24 (a) Comply with the most recent guidelines of the American
25 College of Cardiology and American Heart Association Guidelines
26 for Cardiac Catheterization and Cardiac Catheterization
27 Laboratories.
28 (b) Perform only adult inpatient diagnostic cardiac
29 catheterization services and will not provide therapeutic
30 cardiac catheterization or any other cardiology services.
31 (c) Maintain sufficient appropriate equipment and health
32 care personnel to ensure quality and safety.
33 (d) Maintain appropriate times of operation and protocols
34 to ensure availability and appropriate referrals in the event of
35 emergencies.
36 (e) Demonstrate a plan to provide services to Medicaid and
37 charity care patients.
38 (2) Each provider of adult cardiovascular services or
39 operator of a burn unit shall comply with rules adopted by the
40 agency that establish licensure standards that govern the
41 provision of adult cardiovascular services or the operation of a
42 burn unit. Such rules shall consider, at a minimum, staffing,
43 equipment, physical plant, operating protocols, the provision of
44 services to Medicaid and charity care patients, accreditation,
45 licensure period and fees, and enforcement of minimum standards.
46 The certificate-of-need rules for adult cardiovascular services
47 and burn units in effect on June 30, 2004, are authorized
48 pursuant to this subsection and shall remain in effect and shall
49 be enforceable by the agency until the licensure rules are
50 adopted. Existing providers and any provider with a notice of
51 intent to grant a certificate of need or a final order of the
52 agency granting a certificate of need for adult cardiovascular
53 services or burn units shall be considered grandfathered and
54 receive a license for their programs effective on the effective
55 date of this act. The grandfathered licensure shall be for at
56 least 3 years or until July 1, 2008, whichever is longer, but
57 shall be required to meet licensure standards applicable to
58 existing programs for every subsequent licensure period.
59 (3) In establishing rules for adult cardiovascular
60 services, the agency shall include provisions that allow for:
61 (a) Establishment of two hospital program licensure levels:
62 a Level I program authorizing the performance of adult
63 percutaneous cardiac intervention without onsite cardiac surgery
64 and a Level II program authorizing the performance of
65 percutaneous cardiac intervention with onsite cardiac surgery.
66 (b) For a hospital seeking a Level I program, demonstration
67 that, for the most recent 12-month period as reported to the
68 agency, it has provided a minimum of 300 adult inpatient and
69 outpatient diagnostic cardiac catheterizations or, for the most
70 recent 12-month period, has discharged or transferred at least
71 300 inpatients with the principal diagnosis of ischemic heart
72 disease and that it has a formalized, written transfer agreement
73 with a hospital that has a Level II program, including written
74 transport protocols to ensure safe and efficient transfer of a
75 patient within 60 minutes. However, a hospital located more than
76 100 road miles from the closest Level II adult cardiovascular
77 services program does not need to meet the 60-minute transfer
78 time protocol if the hospital demonstrates that it has a
79 formalized, written transfer agreement with a hospital that has
80 a Level II program. The agreement must include written transport
81 protocols to ensure the safe and efficient transfer of a
82 patient, taking into consideration the patient’s clinical and
83 physical characteristics, road and weather conditions, and
84 viability of ground and air ambulance service to transfer the
85 patient. At a minimum, the rules must require the following:
86 1. Cardiologists must be experienced interventionalists who
87 have performed a minimum of 50 interventions annually, averaged
88 over 2 years, that were performed in institutions performing
89 more than 200 total intervention procedures annually and more
90 than 36 primary intervention procedures annually.
91 2. The hospital must provide a minimum of 36 primary
92 interventions annually in order to continue to provide the
93 service.
94 3. The hospital must offer sufficient physician, nursing,
95 and laboratory staff to provide the services 24 hours a day, 7
96 days a week.
97 4. Nursing and technical staff must have demonstrated
98 experience in handling acutely ill patients requiring
99 intervention based on the staff members’ previous experience in
100 dedicated interventional laboratories or surgical centers. In
101 order for experience acquired at a dedicated interventional
102 laboratory at a hospital without an approved adult open-heart
103 surgery program to qualify, the cardiac interventional
104 laboratory must have, throughout the training period:
105 a. Had an annual volume of 200 or more percutaneous
106 coronary intervention procedures;
107 b. Achieved a demonstrated success rate of 95 percent or
108 greater for percutaneous coronary intervention procedures;
109 c. Experienced a complication rate of less than 5 percent
110 for percutaneous coronary intervention procedures;
111 d. Experienced required emergent coronary artery bypass
112 grafting on less than 2 percent of the patients undergoing a
113 percutaneous coronary intervention procedure; and
114 e. Performed diverse cardiac procedures, including, but not
115 limited to, balloon angioplasty and stenting, rotational
116 atherectomy, cutting balloon atheroma remodeling, and procedures
117 relating to left ventricular support capability.
118 5. Cardiac care nursing staff must be adept in hemodynamic
119 monitoring, operation of temporary pacemakers, intra-aortic
120 balloon pump management, management of indwelling arterial and
121 venous sheaths, and identifying potential complications.
122 6. Hospitals implementing the service must first undertake
123 a training program of 3 to 6 months’ duration, which includes
124 establishing standards and testing logistics, creating quality
125 assessment and error management practices, and formalizing
126 patient-selection criteria.
127 7. The applicant must certify that the hospital will use at
128 all times the patient-selection criteria for the performance of
129 primary angioplasty at hospitals without adult open-heart
130 surgery programs issued by the American College of Cardiology
131 and the American Heart Association.
132 8. The hospital must agree to submit a quarterly report to
133 the agency detailing patient characteristics, treatment, and
134 outcomes for all patients receiving emergency percutaneous
135 coronary interventions pursuant to this paragraph. This report
136 must be submitted within 15 days after the close of each
137 calendar quarter.
138 (c) For a hospital seeking a Level II program,
139 demonstration that, for the most recent 12-month period as
140 reported to the agency, it has performed a minimum of 1,100
141 adult inpatient and outpatient cardiac catheterizations, of
142 which at least 400 must be therapeutic catheterizations, or, for
143 the most recent 12-month period, has discharged at least 800
144 patients with the principal diagnosis of ischemic heart disease.
145 (d) Compliance with the most recent guidelines of the
146 American College of Cardiology and American Heart Association
147 guidelines for staffing, physician training and experience,
148 operating procedures, equipment, physical plant, and patient
149 selection criteria to ensure patient quality and safety.
150 (e) Establishment of appropriate hours of operation and
151 protocols to ensure availability and timely referral in the
152 event of emergencies.
153 (f) Demonstration of a plan to provide services to Medicaid
154 and charity care patients.
155 (4) In order to ensure continuity of available services,
156 the holder of a certificate of need for a newly licensed
157 hospital that meets the requirements of this subsection may
158 apply for and shall be granted Level I program status regardless
159 of whether rules relating to Level I programs have been adopted.
160 To qualify for a Level I program under this subsection, a
161 hospital seeking a Level I program must be a newly licensed
162 hospital established pursuant to a certificate of need in a
163 physical location previously licensed and operated as a
164 hospital, the former hospital must have provided a minimum of
165 300 adult inpatient and outpatient diagnostic cardiac
166 catheterizations for the most recent 12-month period as reported
167 to the agency, and the newly licensed hospital must have a
168 formalized, written transfer agreement with a hospital that has
169 a Level II program, including written transport protocols to
170 ensure safe and efficient transfer of a patient within 60
171 minutes. A hospital meeting the requirements of this subsection
172 may apply for certification of Level I program status before
173 taking possession of the physical location of the former
174 hospital, and the effective date of Level I program status shall
175 be concurrent with the effective date of the newly issued
176 hospital license.
177 (4)(5)(a) The agency shall establish a technical advisory
178 panel to develop procedures and standards for measuring outcomes
179 of adult cardiovascular services. Members of the panel shall
180 include representatives of the Florida Hospital Association, the
181 Florida Society of Thoracic and Cardiovascular Surgeons, the
182 Florida Chapter of the American College of Cardiology, and the
183 Florida Chapter of the American Heart Association and others
184 with experience in statistics and outcome measurement. Based on
185 recommendations from the panel, the agency shall develop and
186 adopt rules for the adult cardiovascular services that include
187 at least the following:
188 1. A risk adjustment procedure that accounts for the
189 variations in severity and case mix found in hospitals in this
190 state.
191 2. Outcome standards specifying expected levels of
192 performance in Level I and Level II adult cardiovascular
193 services. Such standards may include, but shall not be limited
194 to, in-hospital mortality, infection rates, nonfatal myocardial
195 infarctions, length of stay, postoperative bleeds, and returns
196 to surgery.
197 3. Specific steps to be taken by the agency and licensed
198 hospitals that do not meet the outcome standards within
199 specified time periods, including time periods for detailed case
200 reviews and development and implementation of corrective action
201 plans.
202 (b) Hospitals licensed for Level I or Level II adult
203 cardiovascular services shall participate in clinical outcome
204 reporting systems operated by the American College of Cardiology
205 and the Society for Thoracic Surgeons.
206 Section 2. Paragraphs (m) and (n) of subsection (3) of
207 section 408.036, Florida Statutes, are repealed.
208 Section 3. This act shall take effect July 1, 2016.