HB 7165

1	A bill to be entitled
2	An act relating to hospitals; amending s. 395.003, F.S.;
3	revising provisions designating disease classes; exempting
4	certain cancer center hospitals from licensure
5	restrictions; amending s. 408.0361, F.S.; revising
6	provisions relating to licensing standards for adult
7	cardiovascular services; revising period of validity for
8	certain grandfathered licenses; revising criteria for
9	adoption of rules by the Agency for Health Care
10	Administration; requiring certain hospitals to participate
11	in clinical outcome reporting systems operated by the
12	American College of Cardiology and the Society for
13	Thoracic Surgeons for purposes of such rule criteria;
14	removing a requirement that the agency include specified
15	data in rules; providing an effective date.
16
17	Be It Enacted by the Legislature of the State of Florida:
18
19	Section 1.  Subsection (9) of section 395.003, Florida
20	Statutes, is amended to read:
21	395.003  Licensure; issuance, renewal, denial,
22	modification, suspension, and revocation.--
23	(9)  A hospital may not be licensed or relicensed if:
24	(a)  The diagnosis-related groups for 65 percent or more of
25	the discharges from the hospital, in the most recent year for
26	which data is available to the Agency for Health Care
27	Administration pursuant to s. 408.061, are for diagnosis, care,
28	and treatment of patients who have:
29	1.  Cardiac-related diseases and disorders classified as
30	diagnosis-related groups in major diagnostic category 5 103-145,
31	478-479, 514-518, or 525-527;
32	2.  Orthopedic-related diseases and disorders classified as
33	diagnosis-related groups in major diagnostic category 8 209-256,
34	471, 491, 496-503, or 519-520;
35	3.  Cancer-related diseases and disorders classified as
36	discharges in which the principal diagnosis is neoplasm or
37	carcinoma or is for an admission for radiotherapy or
38	antineoplastic chemotherapy or immunotherapy diagnosis-related
39	groups 64, 82, 172, 173, 199, 200, 203, 257-260, 274, 275, 303,
40	306, 307, 318, 319, 338, 344, 346, 347, 363, 366, 367, 400-414,
41	473, or 492; or
42	4.  Any combination of the above discharges.
43	(b)  The hospital restricts its medical and surgical
44	services to primarily or exclusively cardiac, orthopedic,
45	surgical, or oncology specialties.
46	(c)  A hospital classified as an exempt cancer center
47	hospital pursuant to 42 C.F.R. s. 412.23(f) as of December 31,
48	2005, is exempt from the licensure restrictions of this
49	subsection.
50	Section 2.  Subsections (2), (3), and (4) of section
51	408.0361, Florida Statutes, are amended to read:
52	408.0361  Cardiovascular Cardiology services and burn unit
53	licensure.--
54	(2)  Each provider of adult cardiovascular interventional
55	cardiology services or operator of a burn unit shall comply with
56	rules adopted by the agency that establish licensure standards
57	that govern the provision of adult cardiovascular interventional
58	cardiology services or the operation of a burn unit. Such rules
59	shall consider, at a minimum, staffing, equipment, physical
60	plant, operating protocols, the provision of services to
61	Medicaid and charity care patients, accreditation, licensure
62	period and fees, and enforcement of minimum standards. The
63	certificate-of-need rules for adult cardiovascular
64	interventional cardiology services and burn units in effect on
65	June 30, 2004, are authorized pursuant to this subsection and
66	shall remain in effect and shall be enforceable by the agency
67	until the licensure rules are adopted. Existing providers and
68	any provider with a notice of intent to grant a certificate of
69	need or a final order of the agency granting a certificate of
70	need for adult cardiovascular interventional cardiology services
71	or burn units shall be considered grandfathered and receive a
72	license for their programs effective on the effective date of
73	this act. The grandfathered licensure shall be for at least 3
74	years or until July 1, 2008 a period specified in the rule,
75	whichever is longer, but shall be required to meet licensure
76	standards applicable to existing programs for every subsequent
77	licensure period.
78	(3)  In establishing rules for adult cardiovascular
79	interventional cardiology services, the agency shall include
80	provisions that allow for:
81	(a)  Establishment of two hospital program licensure
82	levels: a Level I program authorizing the performance of adult
83	percutaneous cardiac intervention without onsite cardiac surgery
84	and a Level II program authorizing the performance of
85	percutaneous cardiac intervention with onsite cardiac surgery.
86	(b)  For a hospital seeking a Level I program,
87	demonstration that, for the most recent 12-month period as
88	reported to the agency, it has provided a minimum of 300 adult
89	inpatient and outpatient diagnostic cardiac catheterizations or,
90	for the most recent 12-month period, has discharged or
91	transferred at least 300 inpatients with the principal diagnosis
92	of ischemic heart disease and that it has a formalized, written
93	transfer agreement with a hospital that has a Level II program,
94	including written transport protocols to ensure safe and
95	efficient transfer of a patient within 60 minutes.
96	(c)  For a hospital seeking a Level II program,
97	demonstration that, for the most recent 12-month period as
98	reported to the agency, it has performed a minimum of 1,100
99	adult inpatient and outpatient cardiac catheterizations, of
100	which at least 400 must be therapeutic catheterizations, or, for
101	the most recent 12-month period, has discharged at least 800
102	patients with the principal diagnosis of ischemic heart disease.
103	(d)  Compliance with the most recent guidelines of the
104	American College of Cardiology and American Heart Association
105	guidelines for staffing, physician training and experience,
106	operating procedures, equipment, physical plant, and patient
107	selection criteria to ensure patient quality and safety.
108	(e)  Establishment of appropriate hours of operation and
109	protocols to ensure availability and timely referral in the
110	event of emergencies.
111	(f)  Demonstration of a plan to provide services to
112	Medicaid and charity care patients.
113	(4)(a)  The agency shall establish a technical advisory
114	panel to develop procedures and standards for measuring outcomes
115	of adult cardiovascular services interventional cardiac
116	programs. Members of the panel shall include representatives of
117	the Florida Hospital Association, the Florida Society of
118	Thoracic and Cardiovascular Surgeons, the Florida Chapter of the
119	American College of Cardiology, and the Florida Chapter of the
120	American Heart Association and others with experience in
121	statistics and outcome measurement. Based on recommendations
122	from the panel, the agency shall develop and adopt rules for the
123	adult cardiovascular services interventional cardiac programs
124	that include at least the following:
125	(a)   A standard data set consisting primarily of data
126	elements reported to the agency in accordance with s. 408.061.
127	1.(b)  A risk adjustment procedure that accounts for the
128	variations in severity and case mix found in hospitals in this
129	state.
130	2.(c)  Outcome standards specifying expected levels of
131	performance in Level I and Level II adult cardiovascular
132	interventional cardiology services. Such standards may include,
133	but shall not be limited to, in-hospital mortality, infection
134	rates, nonfatal myocardial infarctions, length of stay,
135	postoperative bleeds, and returns to surgery.
136	3.(d)  Specific steps to be taken by the agency and
137	licensed hospitals that do not meet the outcome standards within
138	specified time periods, including time periods for detailed case
139	reviews and development and implementation of corrective action
140	plans.
141	(b)  Hospitals licensed for Level I or Level II adult
142	cardiovascular services shall participate in clinical outcome
143	reporting systems operated by the American College of Cardiology
144	and the Society for Thoracic Surgeons.
145	Section 3.  This act shall take effect July 1, 2007.

CODING: Words stricken are deletions; words underlined are additions.