Senate Bill sb0760c1
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Florida Senate - 2007 CS for SB 760
By the Committee on Health Regulation; and Senator Atwater
588-2561-07
1 A bill to be entitled
2 An act relating to hospitals; amending s.
3 395.003, F.S.; revising provisions designating
4 classes of disease; exempting certain cancer
5 center hospitals from licensure restrictions;
6 amending s. 408.0361, F.S.; revising provisions
7 relating to licensing standards for adult
8 cardiovascular services; revising the period of
9 validity for certain licenses authorized under
10 a grandfather provision; revising the criteria
11 for the adoption of rules by the Agency for
12 Health Care Administration; requiring certain
13 hospitals to participate in clinical
14 outcome-reporting systems operated by the
15 American College of Cardiology and the Society
16 for Thoracic Surgeons for purposes of such rule
17 criteria; removing a requirement that the
18 agency include specified data in rules;
19 providing an effective date.
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21 Be It Enacted by the Legislature of the State of Florida:
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23 Section 1. Subsection (9) of section 395.003, Florida
24 Statutes, is amended to read:
25 395.003 Licensure; issuance, renewal, denial,
26 modification, suspension, and revocation.--
27 (9) A hospital may not be licensed or relicensed if:
28 (a) The diagnosis-related groups for 65 percent or
29 more of the discharges from the hospital, in the most recent
30 year for which data is available to the Agency for Health Care
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Florida Senate - 2007 CS for SB 760
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1 Administration pursuant to s. 408.061, are for diagnosis,
2 care, and treatment of patients who have:
3 1. Cardiac-related diseases and disorders classified
4 as diagnosis-related groups in major diagnostic category 5
5 103-145, 478-479, 514-518, or 525-527;
6 2. Orthopedic-related diseases and disorders
7 classified as diagnosis-related groups in major diagnostic
8 category 8 209-256, 471, 491, 496-503, or 519-520;
9 3. Cancer-related diseases and disorders classified as
10 discharges in which the principal diagnosis is neoplasm or
11 carcinoma or is for an admission for radiotherapy or
12 antineoplastic chemotherapy or immunotherapy diagnosis-related
13 groups 64, 82, 172, 173, 199, 200, 203, 257-260, 274, 275,
14 303, 306, 307, 318, 319, 338, 344, 346, 347, 363, 366, 367,
15 400-414, 473, or 492; or
16 4. Any combination of the above discharges. Any
17 hospital classified as an exempt cancer center hospital
18 pursuant to 42 C.F.R. s. 412.23(f) as of December 31, 2005, is
19 exempt from the licensure restrictions of this subsection.
20 (b) The hospital restricts its medical and surgical
21 services to primarily or exclusively cardiac, orthopedic,
22 surgical, or oncology specialties.
23 Section 2. Section 408.0361, Florida Statutes, is
24 amended to read:
25 408.0361 Cardiovascular Cardiology services and burn
26 unit licensure.--
27 (1) Each provider of diagnostic cardiac
28 catheterization services shall comply with rules adopted by
29 the agency that establish licensure standards governing the
30 operation of adult inpatient diagnostic cardiac
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Florida Senate - 2007 CS for SB 760
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1 catheterization programs. The rules shall ensure that such
2 programs:
3 (a) Comply with the most recent guidelines of the
4 American College of Cardiology and American Heart Association
5 Guidelines for Cardiac Catheterization and Cardiac
6 Catheterization Laboratories.
7 (b) Perform only adult inpatient diagnostic cardiac
8 catheterization services and will not provide therapeutic
9 cardiac catheterization or any other cardiology services.
10 (c) Maintain sufficient appropriate equipment and
11 health care personnel to ensure quality and safety.
12 (d) Maintain appropriate times of operation and
13 protocols to ensure availability and appropriate referrals in
14 the event of emergencies.
15 (e) Demonstrate a plan to provide services to Medicaid
16 and charity care patients.
17 (2) Each provider of adult cardiovascular
18 interventional cardiology services or operator of a burn unit
19 shall comply with rules adopted by the agency that establish
20 licensure standards that govern the provision of adult
21 cardiovascular interventional cardiology services or the
22 operation of a burn unit. Such rules shall consider, at a
23 minimum, staffing, equipment, physical plant, operating
24 protocols, the provision of services to Medicaid and charity
25 care patients, accreditation, licensure period and fees, and
26 enforcement of minimum standards. The certificate-of-need
27 rules for adult cardiovascular interventional cardiology
28 services and burn units in effect on June 30, 2004, are
29 authorized pursuant to this subsection and shall remain in
30 effect and shall be enforceable by the agency until the
31 licensure rules are adopted. Existing providers and any
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Florida Senate - 2007 CS for SB 760
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1 provider with a notice of intent to grant a certificate of
2 need or a final order of the agency granting a certificate of
3 need for adult cardiovascular interventional cardiology
4 services or burn units shall be considered grandfathered and
5 receive a license for their programs effective on the
6 effective date of this act. The grandfathered licensure shall
7 be for at least 3 years or until July 1, 2008 a period
8 specified in the rule, whichever is longer, but shall be
9 required to meet licensure standards applicable to existing
10 programs for every subsequent licensure period.
11 (3) In establishing rules for adult cardiovascular
12 interventional cardiology services, the agency shall include
13 provisions that allow for:
14 (a) Establishment of two hospital program licensure
15 levels: a Level I program authorizing the performance of adult
16 percutaneous cardiac intervention without onsite cardiac
17 surgery and a Level II program authorizing the performance of
18 percutaneous cardiac intervention with onsite cardiac surgery.
19 (b) For a hospital seeking a Level I program,
20 demonstration that, for the most recent 12-month period as
21 reported to the agency, it has provided a minimum of 300 adult
22 inpatient and outpatient diagnostic cardiac catheterizations
23 or, for the most recent 12-month period, has discharged or
24 transferred at least 300 inpatients with the principal
25 diagnosis of ischemic heart disease and that it has a
26 formalized, written transfer agreement with a hospital that
27 has a Level II program, including written transport protocols
28 to ensure safe and efficient transfer of a patient within 60
29 minutes.
30 (c) For a hospital seeking a Level II program,
31 demonstration that, for the most recent 12-month period as
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1 reported to the agency, it has performed a minimum of 1,100
2 adult inpatient and outpatient cardiac catheterizations, of
3 which at least 400 must be therapeutic catheterizations, or,
4 for the most recent 12-month period, has discharged at least
5 800 patients with the principal diagnosis of ischemic heart
6 disease.
7 (d) Compliance with the most recent guidelines of the
8 American College of Cardiology and American Heart Association
9 guidelines for staffing, physician training and experience,
10 operating procedures, equipment, physical plant, and patient
11 selection criteria to ensure patient quality and safety.
12 (e) Establishment of appropriate hours of operation
13 and protocols to ensure availability and timely referral in
14 the event of emergencies.
15 (f) Demonstration of a plan to provide services to
16 Medicaid and charity care patients.
17 (4)(a) The agency shall establish a technical advisory
18 panel to develop procedures and standards for measuring
19 outcomes of adult cardiovascular services interventional
20 cardiac programs. Members of the panel shall include
21 representatives of the Florida Hospital Association, the
22 Florida Society of Thoracic and Cardiovascular Surgeons, the
23 Florida Chapter of the American College of Cardiology, and the
24 Florida Chapter of the American Heart Association and others
25 with experience in statistics and outcome measurement. Based
26 on recommendations from the panel, the agency shall develop
27 and adopt rules for the adult cardiovascular services which
28 interventional cardiac programs that include at least the
29 following:
30 (a) A standard data set consisting primarily of data
31 elements reported to the agency in accordance with s. 408.061.
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Florida Senate - 2007 CS for SB 760
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1 1.(b) A risk adjustment procedure that accounts for
2 the variations in severity and case mix found in hospitals in
3 this state.
4 2.(c) Outcome standards specifying expected levels of
5 performance in Level I and Level II adult cardiovascular
6 interventional cardiology services. Such standards may
7 include, but shall not be limited to, in-hospital mortality,
8 infection rates, nonfatal myocardial infarctions, length of
9 stay, postoperative bleeds, and returns to surgery.
10 3.(d) Specific steps to be taken by the agency and
11 licensed hospitals that do not meet the outcome standards
12 within specified time periods, including time periods for
13 detailed case reviews and development and implementation of
14 corrective action plans.
15 (b) Hospitals licensed for Level I or Level II adult
16 cardiovascular services shall participate in clinical
17 outcome-reporting systems operated by the American College of
18 Cardiology and the Society for Thoracic Surgeons.
19 (5) The Secretary of Health Care Administration shall
20 appoint an advisory group to study the issue of replacing
21 certificate-of-need review of organ transplant programs under
22 this chapter with licensure regulation of organ transplant
23 programs under chapter 395. The advisory group shall include
24 three representatives of organ transplant providers, one
25 representative of an organ procurement organization, one
26 representative of the Division of Health Quality Assurance,
27 one representative of Medicaid, and one organ transplant
28 patient advocate. The advisory group shall, at minimum, make
29 recommendations regarding access to organs, delivery of
30 services to Medicaid and charity care patients, staff
31 training, and resource requirements for organ transplant
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Florida Senate - 2007 CS for SB 760
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1 programs in a report due to the secretary and the Legislature
2 by July 1, 2005.
3 (6) The Secretary of Health Care Administration shall
4 appoint a workgroup to study certificate-of-need regulations
5 and changing market conditions related to the supply and
6 distribution of hospital beds. The assessment by the workgroup
7 shall include, but not be limited to, the following:
8 (a) The appropriateness of current certificate-of-need
9 methodologies and other criteria for evaluating proposals for
10 new hospitals and transfer of beds to new sites.
11 (b) Additional factors that should be considered,
12 including the viability of safety net services, the extent of
13 market competition, and the accessibility of hospital
14 services.
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16 The workgroup shall submit a report by January 1, 2005, to the
17 secretary and the Legislature identifying specific problem
18 areas and recommending needed changes in statutes or rules.
19 Section 3. This act shall take effect July 1, 2007.
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Florida Senate - 2007 CS for SB 760
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1 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
2 Senate Bill 760
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4 The committee substitute revises the definition of the types
of specialty hospitals that may not be licensed by the Agency
5 for Health Care Administration (AHCA or agency).
6 The committee substitute changes the terms cardiology and
cardiovascular services throughout s. 408.0361, F.S., which
7 relates to licensure of hospital cardiology services and burn
units. The grandfathered licensure status of certain hospitals
8 with adult interventional cardiology services and or burn
units is changed from a period specified in rule to until July
9 1, 2008.
10 The committee substitute deletes the inclusion in rules of a
standard data set consisting of data elements reported to the
11 AHCA in accordance with s. 408.061, F.S. It also requires
Level I and Level II hospitals to participate in clinical
12 outcome-reporting systems operated by the American College of
Cardiology and the Society for Thoracic Surgeons.
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