HB 1105 2003
1	CHAMBER ACTION
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6	The Committee on Health Care recommends the following:
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8	Committee Substitute
9	Remove the entire bill and insert:
10	A bill to be entitled
11	An act relating to health care facilities; amending s.
12	408.032, F.S.; revising the definition of "tertiary health
13	service" under the Health Facility and Services
14	Development Act; amending s. 408.033, F.S.; providing for
15	the level of funding for local health councils; amending
16	s. 408.036, F.S., relating to health-care-related projects
17	subject to review for a certificate of need; removing
18	certain projects from expedited review and revising
19	requirements for other projects subject to expedited
20	review; removing the exemption from review for certain
21	projects; revising requirements for certain projects that
22	are exempt from review; exempting certain projects from
23	review; amending s. 408.038, F.S.; increasing fees of the
24	certificate-of-need program; amending s. 408.039, F.S.;
25	providing for approval of recommended orders of the
26	Division of Administrative Hearings when the Agency for
27	Health Care Administration fails to take action on an
28	application for a certificate of need within a specified
29	time period; amending s. 400.021, F.S.; revising the
30	definition of "resident care plan"; amending s. 400.121,
31	F.S.; deleting a provision authorizing the overcoming of
32	agency action by a preponderance of the evidence; amending
33	s. 400.141, F.S.; narrowing the responsibilities for a
34	nursing assistant to maintain medical records only for
35	residents who are at high risk for malnutrition or
36	dehydration as ordered by the resident's physician;
37	amending s. 400.147, F.S.; revising the definition of
38	"adverse incident" to eliminate certain events from the
39	term; revising reporting requirements; amending s. 400.19,
40	F.S.; revising the agency's authority to enter and inspect
41	a nursing home based on final agency action that a
42	facility has a deficiency cited; amending s. 400.195,
43	F.S.; conforming a cross reference; amending s. 400.211,
44	F.S.; requiring nursing assistants to meet certain
45	inservice training requirements to maintain certification;
46	amending s. 400.23, F.S.; revising requirements regarding
47	rules, evaluation and deficiencies, and licensure status
48	of nursing homes; creating s. 400.244, F.S.; allowing
49	nursing homes to convert beds to alternative uses as
50	specified; providing restrictions on uses of funding under
51	assisted-living Medicaid waivers; providing procedures;
52	providing for the applicability of certain fire and life
53	safety codes; providing applicability of certain laws;
54	requiring a nursing home to submit to the Agency for
55	Health Care Administration a written request for
56	permission to convert beds to alternative uses; providing
57	conditions for disapproving such a request; providing for
58	periodic review; providing for retention of nursing home
59	licensure for converted beds; providing for reconversion
60	of the beds; providing applicability of licensure fees;
61	requiring a report to the agency; creating the Hospital
62	Statutory and Regulatory Reform Council; providing
63	legislative intent; providing for membership and duties of
64	the council; providing an effective date.
65
66	Be It Enacted by the Legislature of the State of Florida:
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68	Section 1. Subsection (17) of section 408.032, Florida
69	Statutes, is amended to read:
70	408.032 Definitions relating to Health Facility and
71	Services Development Act.--As used in ss. 408.031-408.045, the
72	term:
73	(17) "Tertiary health service" means a health service
74	which, due to its high level of intensity, complexity,
75	specialized or limited applicability, and cost, should be
76	limited to, and concentrated in, a limited number of hospitals
77	to ensure the quality, availability, and cost-effectiveness of
78	such service. Examples of such service include, but are not
79	limited to, organ transplantation, adult and pediatric open
80	heart surgery,specialty burn units, neonatal intensive care
81	units, comprehensive rehabilitation, and medical or surgical
82	services which are experimental or developmental in nature to
83	the extent that the provision of such services is not yet
84	contemplated within the commonly accepted course of diagnosis or
85	treatment for the condition addressed by a given service. The
86	agency shall establish by rule a list of all tertiary health
87	services.
88	Section 2. Paragraph (g) is added to subsection (2) of
89	section 408.033, Florida Statutes, to read:
90	408.033 Local and state health planning.--
91	(2) FUNDING.--
92	(g) Effective July 1, 2003, funding for the local health
93	councils shall be at the level provided on July 1, 2002.
94	Section 3. Section 408.036, Florida Statutes, is amended
95	to read:
96	408.036 Projects subject to review; exemptions.--
97	(1) APPLICABILITY.--Unless exempt under subsection (3),
98	all health-care-related projects, as described in paragraphs
99	(a)-(h), are subject to review and must file an application for
100	a certificate of need with the agency. The agency is exclusively
101	responsible for determining whether a health-care-related
102	project is subject to review under ss. 408.031-408.045.
103	(a) The addition of beds by new construction or
104	alteration.
105	(b) The new construction or establishment of additional
106	health care facilities, including a replacement health care
107	facility when the proposed project site is not located on the
108	same site as the existing health care facility.
109	(c) The conversion from one type of health care facility
110	to another.
111	(d) An increase in the total licensed bed capacity of a
112	health care facility.
113	(e) The establishment of a hospice or hospice inpatient
114	facility, except as provided in s. 408.043.
115	(f) The establishment of inpatient health services by a
116	health care facility, or a substantial change in such services.
117	(g) An increase in the number of beds for acute care,
118	nursing home care beds, specialty burn units, neonatal intensive
119	care units, comprehensive rehabilitation, mental health
120	services, or hospital-based distinct part skilled nursing units,
121	or at a long-term care hospital.
122	(h) The establishment of tertiary health services.
123	(2) PROJECTS SUBJECT TO EXPEDITED REVIEW.--Unless exempt
124	pursuant to subsection (3), projects subject to an expedited
125	review shall include, but not be limited to:
126	(a) Research, education, and training programs.
127	(b) Shared services contracts or projects.
128	(b)(c) A transfer of a certificate of need, except when an
129	existing hospital is acquired by a purchaser, in which case all
130	pending certificates of need filed by the existing hospital and
131	all approved certificates of need owned by that hospital would
132	be acquired by the purchaser.
133	(c)(d)A 50-percent increase in nursing home beds for a
134	facility incorporated and operating in this state for at least
135	60 years on or before July 1, 1988, which has a licensed nursing
136	home facility located on a campus providing a variety of
137	residential settings and supportive services. The increased
138	nursing home beds shall be for the exclusive use of the campus
139	residents. Any application on behalf of an applicant meeting
140	this requirement shall be subject to the base fee of $5,000
141	provided in s. 408.038.
142	(d)(e)Replacement of a health care facility when the
143	proposed project site is located in the same district and within
144	a 1-mile radius of the replaced health care facility.
145	(e)(f)The conversion of mental health services beds
146	licensed under chapter 395 or hospital-based distinct part
147	skilled nursing unit beds to general acute care beds; the
148	conversion of mental health services beds between or among the
149	licensed bed categories defined as beds for mental health
150	services;or the conversion of general acute care beds to beds
151	for mental health services.
152	1. Conversion under this paragraph shall not establish a
153	new licensed bed category at the hospital but shall apply only
154	to categories of beds licensed at that hospital.
155	2. Beds converted under this paragraph must be licensed
156	and operational for at least 12 months before the hospital may
157	apply for additional conversion affecting beds of the same type.
158
159	The agency shall develop rules to implement the provisions for
160	expedited review, including time schedule, application content
161	which may be reduced from the full requirements of s.
162	408.037(1), and application processing.
163	(3) EXEMPTIONS.--Upon request, the following projects are
164	subject to exemption from the provisions of subsection (1):
165	(a) For replacement of a licensed health care facility on
166	the same site, provided that the number of beds in each licensed
167	bed category will not increase.
168	(b) For hospice services or for swing beds in a rural
169	hospital, as defined in s. 395.602, in a number that does not
170	exceed one-half of its licensed beds.
171	(c) For the conversion of licensed acute care hospital
172	beds to Medicare and Medicaid certified skilled nursing beds in
173	a rural hospital, as defined in s. 395.602, so long as the
174	conversion of the beds does not involve the construction of new
175	facilities. The total number of skilled nursing beds, including
176	swing beds, may not exceed one-half of the total number of
177	licensed beds in the rural hospital as of July 1, 1993.
178	Certified skilled nursing beds designated under this paragraph,
179	excluding swing beds, shall be included in the community nursing
180	home bed inventory. A rural hospital which subsequently
181	decertifies any acute care beds exempted under this paragraph
182	shall notify the agency of the decertification, and the agency
183	shall adjust the community nursing home bed inventory
184	accordingly.
185	(d) For the addition of nursing home beds at a skilled
186	nursing facility that is part of a retirement community that
187	provides a variety of residential settings and supportive
188	services and that has been incorporated and operated in this
189	state for at least 65 years on or before July 1, 1994. All
190	nursing home beds must not be available to the public but must
191	be for the exclusive use of the community residents.
192	(e) For an increase in the bed capacity of a nursing
193	facility licensed for at least 50 beds as of January 1, 1994,
194	under part II of chapter 400 which is not part of a continuing
195	care facility if, after the increase, the total licensed bed
196	capacity of that facility is not more than 60 beds and if the
197	facility has been continuously licensed since 1950 and has
198	received a superior rating on each of its two most recent
199	licensure surveys.
200	(f) For an inmate health care facility built by or for the
201	exclusive use of the Department of Corrections as provided in
202	chapter 945. This exemption expires when such facility is
203	converted to other uses.
204	(g) For the termination of an inpatient health care
205	service, upon 30 days' written notice to the agency.
206	(h) For the delicensure of beds, upon 30 days' written
207	notice to the agency. A request for exemption submitted under
208	this paragraph must identify the number, the category of beds,
209	and the name of the facility in which the beds to be delicensed
210	are located.
211	(i) For the provision of adult inpatient diagnostic
212	cardiac catheterization services in a hospital.
213	1. In addition to any other documentation otherwise
214	required by the agency, a request for an exemption submitted
215	under this paragraph must comply with the following criteria:
216	a. The applicant must certify it will not provide
217	therapeutic cardiac catheterization pursuant to the grant of the
218	exemption.
219	b. The applicant must certify it will meet and
220	continuously maintain the minimum licensure requirements adopted
221	by the agency governing such programs pursuant to subparagraph
222	2.
223	c. The applicant must certify it will provide a minimum of
224	2 percent of its services to charity and Medicaid patients.
225	2. The agency shall adopt licensure requirements by rule
226	which govern the operation of adult inpatient diagnostic cardiac
227	catheterization programs established pursuant to the exemption
228	provided in this paragraph. The rules shall ensure that such
229	programs:
230	a. Perform only adult inpatient diagnostic cardiac
231	catheterization services authorized by the exemption and will
232	not provide therapeutic cardiac catheterization or any other
233	services not authorized by the exemption.
234	b. Maintain sufficient appropriate equipment and health
235	personnel to ensure quality and safety.
236	c. Maintain appropriate times of operation and protocols
237	to ensure availability and appropriate referrals in the event of
238	emergencies.
239	d. Maintain appropriate program volumes to ensure quality
240	and safety.
241	e. Provide a minimum of 2 percent of its services to
242	charity and Medicaid patients each year.
243	3.a. The exemption provided by this paragraph shall not
244	apply unless the agency determines that the program is in
245	compliance with the requirements of subparagraph 1. and that the
246	program will, after beginning operation, continuously comply
247	with the rules adopted pursuant to subparagraph 2. The agency
248	shall monitor such programs to ensure compliance with the
249	requirements of subparagraph 2.
250	b.(I) The exemption for a program shall expire immediately
251	when the program fails to comply with the rules adopted pursuant
252	to sub-subparagraphs 2.a., b., and c.
253	(II) Beginning 18 months after a program first begins
254	treating patients, the exemption for a program shall expire when
255	the program fails to comply with the rules adopted pursuant to
256	sub-subparagraphs 2.d. and e.
257	(III) If the exemption for a program expires pursuant to
258	sub-sub-subparagraph (I) or sub-sub-subparagraph (II), the
259	agency shall not grant an exemption pursuant to this paragraph
260	for an adult inpatient diagnostic cardiac catheterization
261	program located at the same hospital until 2 years following the
262	date of the determination by the agency that the program failed
263	to comply with the rules adopted pursuant to subparagraph 2.
264	(j) For the provision of percutaneous coronary
265	intervention for patients presenting with emergency myocardial
266	infarctions in a hospital without an approved adult open heart
267	surgery program. In addition to any other documentation required
268	by the agency, a request for an exemption submitted under this
269	paragraph must comply with the following:
270	1. The applicant must certify that it will meet and
271	continuously maintain the requirements adopted by the agency for
272	the provision of these services. These licensure requirements
273	are to be adopted by rule pursuant to ss. 120.536(1) and 120.54
274	and are to be consistent with the guidelines published by the
275	American College of Cardiology and the American Heart
276	Association for the provision of percutaneous coronary
277	interventions in hospitals without adult open heart services. At
278	a minimum, the rules shall require the following:
279	a. Cardiologists must be experienced interventionalists
280	who have performed a minimum of 75 interventions within the
281	previous 12 months.
282	b. The hospital must provide a minimum of 36 emergency
283	interventions annually in order to continue to provide the
284	service.
285	c. The hospital must offer sufficient physician, nursing,
286	and laboratory staff to provide the services 24 hours a day, 7
287	days a week.
288	d. Nursing and technical staff must have demonstrated
289	experience in handling acutely ill patients requiring
290	intervention based on previous experience in dedicated
291	interventional laboratories or surgical centers.
292	e. Cardiac care nursing staff must be adept in hemodynamic
293	monitoring and Intra-aortic Balloon Pump (IABP) management.
294	f. Formalized written transfer agreements must be
295	developed with a hospital with an adult open heart surgery
296	program, and written transport protocols must be in place to
297	ensure safe and efficient transfer of a patient within 60
298	minutes. Transfer and transport agreements must be reviewed and
299	tested, with appropriate documentation maintained at least every
300	3 months.
301	g. Hospitals implementing the service must first undertake
302	a training program of 3 to 6 months which includes establishing
303	standards, testing logistics, creating quality assessment and
304	error management practices, and formalizing patient selection
305	criteria.
306	2. The applicant must certify that it will utilize at all
307	times the patient selection criteria for the performance of
308	primary angioplasty at hospitals without adult open heart
309	surgery programs issued by the American College of Cardiology
310	and the American Heart Association. At a minimum, these criteria
311	would provide for the following:
312	a. Avoidance of interventions in hemodynamically stable
313	patients presenting with identified symptoms or medical
314	histories.
315	b. Transfer of patients presenting with a history of
316	coronary disease and clinical presentation of hemodynamic
317	instability.
318	3. The applicant must agree to submit a quarterly report
319	to the agency detailing patient characteristics, treatment, and
320	outcomes for all patients receiving emergency percutaneous
321	coronary interventions pursuant to this paragraph. This report
322	must be submitted within 15 days after the close of each
323	calendar quarter.
324	4. The exemption provided by this paragraph shall not
325	apply unless the agency determines that the hospital has taken
326	all necessary steps to be in compliance with all requirements of
327	this paragraph, including the training program required pursuant
328	to sub-subparagraph 1.g.
329	5. Failure of the hospital to continuously comply with the
330	requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2.
331	and 3. will result in the immediate expiration of this
332	exemption.
333	6. Failure of the hospital to meet the volume requirements
334	of sub-subparagraphs 1.a.-b. within 18 months after the program
335	begins offering the service will result in the immediate
336	expiration of the exemption.
337	7. If the exemption for this service expires pursuant to
338	subparagraph 5. or subparagraph 6., the agency shall not grant
339	another exemption for this service to the same hospital for a
340	period of 2 years and then only upon a showing that the hospital
341	will remain in compliance with the requirements of this
342	paragraph through a demonstration of corrections to the
343	deficiencies which caused expiration of the exemption.
344	Compliance with the requirements of this paragraph includes
345	compliance with the rules adopted pursuant to this paragraph.
346	(k)(j)For mobile surgical facilities and related health
347	care services provided under contract with the Department of
348	Corrections or a private correctional facility operating
349	pursuant to chapter 957.
350	(l)(k)For state veterans' nursing homes operated by or on
351	behalf of the Florida Department of Veterans' Affairs in
352	accordance with part II of chapter 296 for which at least 50
353	percent of the construction cost is federally funded and for
354	which the Federal Government pays a per diem rate not to exceed
355	one-half of the cost of the veterans' care in such state nursing
356	homes. These beds shall not be included in the nursing home bed
357	inventory.
358	(m)(l)For combination within one nursing home facility of
359	the beds or services authorized by two or more certificates of
360	need issued in the same planning subdistrict. An exemption
361	granted under this paragraph shall extend the validity period of
362	the certificates of need to be consolidated by the length of the
363	period beginning upon submission of the exemption request and
364	ending with issuance of the exemption. The longest validity
365	period among the certificates shall be applicable to each of the
366	combined certificates.
367	(n)(m)For division into two or more nursing home
368	facilities of beds or services authorized by one certificate of
369	need issued in the same planning subdistrict. An exemption
370	granted under this paragraph shall extend the validity period of
371	the certificate of need to be divided by the length of the
372	period beginning upon submission of the exemption request and
373	ending with issuance of the exemption.
374	(o)(n)For the addition of hospital beds licensed under
375	chapter 395 for acute care, mental health services,or a
376	hospital-based distinct part skilled nursing unit in a number
377	that may not exceed 3010total beds or 10 percent of the
378	licensed capacity of the bed category being expanded, whichever
379	is greater; for the addition of medical rehabilitation beds
380	licensed under chapter 395 in a number that may not exceed eight
381	total beds or 10 percent of capacity, whichever is greater; or
382	for the addition of mental health services beds licensed under
383	chapter 395 in a number that may not exceed 10 total beds or 10
384	percent of the licensed capacity of the bed category being
385	expanded, whichever is greater. Beds for specialty burn units
386	or, neonatal intensive care units, or comprehensive
387	rehabilitation, or at a long-term care hospital, may not be
388	increased under this paragraph.
389	1. In addition to any other documentation otherwise
390	required by the agency, a request for exemption submitted under
391	this paragraph must:
392	a. Certify that the prior 12-month average occupancy rate
393	for the category of licensed beds being expanded at the facility
394	meets or exceeds 7580percent or, for a hospital-based distinct
395	part skilled nursing unit, the prior 12-month average occupancy
396	rate meets or exceeds 96 percent or, for medical rehabilitation
397	beds, the prior 12-month average occupancy rate meets or exceeds
398	90 percent.
399	b. Certify that any beds of the same type authorized for
400	the facility under this paragraph before the date of the current
401	request for an exemption have been licensed and operational for
402	at least 12 months.
403	2. The timeframes and monitoring process specified in s.
404	408.040(2)(a)-(c) apply to any exemption issued under this
405	paragraph.
406	3. The agency shall count beds authorized under this
407	paragraph as approved beds in the published inventory of
408	hospital beds until the beds are licensed.
409	(p)(o)For the addition of acute care beds, as authorized
410	by rule consistent with s. 395.003(4), in a number that may not
411	exceed 3010total beds or 10 percent of licensed bed capacity,
412	whichever is greater, for temporary beds in a hospital that has
413	experienced high seasonal occupancy within the prior 12-month
414	period or in a hospital that must respond to emergency
415	circumstances.
416	(q)(p)For the addition of nursing home beds licensed
417	under chapter 400 in a number not exceeding 10 total beds or 10
418	percent of the number of beds licensed in the facility being
419	expanded, whichever is greater.
420	1. In addition to any other documentation required by the
421	agency, a request for exemption submitted under this paragraph
422	must:
423	a. Effective until June 30, 2001, certify that the
424	facility has not had any class I or class II deficiencies within
425	the 30 months preceding the request for addition.
426	b. Effective on July 1, 2001, certify that the facility
427	has been designated as a Gold Seal nursing home under s.
428	400.235.
429	c. Certify that the prior 12-month average occupancy rate
430	for the nursing home beds at the facility meets or exceeds 96
431	percent.
432	d. Certify that any beds authorized for the facility under
433	this paragraph before the date of the current request for an
434	exemption have been licensed and operational for at least 12
435	months.
436	2. The timeframes and monitoring process specified in s.
437	408.040(2)(a)-(c) apply to any exemption issued under this
438	paragraph.
439	3. The agency shall count beds authorized under this
440	paragraph as approved beds in the published inventory of nursing
441	home beds until the beds are licensed.
442	(q) For establishment of a specialty hospital offering a
443	range of medical service restricted to a defined age or gender
444	group of the population or a restricted range of services
445	appropriate to the diagnosis, care, and treatment of patients
446	with specific categories of medical illnesses or disorders,
447	through the transfer of beds and services from an existing
448	hospital in the same county.
449	(r) For the conversion of hospital-based Medicare and
450	Medicaid certified skilled nursing beds to acute care beds, if
451	the conversion does not involve the construction of new
452	facilities.
453	(s) For the replacement of a statutory rural hospital when
454	the proposed project site is located in the same district and
455	within 10 miles of the existing facility and within the current
456	primary service area, defined as the least number of zip codes
457	comprising 75 percent of the hospital's inpatient admissions.
458	For fiscal year 2001-2002 only, for transfer by a health care
459	system of existing services and not more than 100 licensed and
460	approved beds from a hospital in district 1, subdistrict 1, to
461	another location within the same subdistrict in order to
462	establish a satellite facility that will improve access to
463	outpatient and inpatient care for residents of the district and
464	subdistrict and that will use new medical technologies,
465	including advanced diagnostics, computer assisted imaging, and
466	telemedicine to improve care. This paragraph is repealed on July
467	1, 2002.
468	(t) For the conversion of mental health services beds
469	between or among the licensed bed categories defined as beds for
470	mental health services.
471	(u) For the creation of at least a 10-bed Level II
472	neonatal intensive care unit upon demonstrating to the agency
473	that the applicant hospital had a minimum of 1,500 live births
474	during the previous 12 months.
475	(v) For the addition of Level II or Level III neonatal
476	intensive care beds in a number not to exceed six beds or 10
477	percent of licensed capacity in that category, whichever is
478	greater, provided that the hospital certifies that the prior 12-
479	month average occupancy rate for the category of licensed
480	neonatal intensive care beds meets or exceeds 75 percent.
481	(4) A request for exemption under subsection (3) may be
482	made at any time and is not subject to the batching requirements
483	of this section. The request shall be supported by such
484	documentation as the agency requires by rule. The agency shall
485	assess a fee of $250 for each request for exemption submitted
486	under subsection (3).
487	Section 4. Section 408.038, Florida Statutes, is amended
488	to read:
489	408.038 Fees.--The agency shall assess fees on
490	certificate-of-need applications. Such fees shall be for the
491	purpose of funding the functions of the local health councils
492	and the activities of the agency and shall be allocated as
493	provided in s. 408.033. The fee shall be determined as follows:
494	(1) A minimum base fee of $10,000$5,000.
495	(2) In addition to the base fee of $10,000$5,000, 0.015
496	of each dollar of proposed expenditure, except that a fee may
497	not exceed $50,000$22,000.
498	Section 5. Paragraph (e) of subsection (5) and paragraph
499	(c) of subsection (6) of section 408.039, Florida Statutes, are
500	amended to read:
501	408.039 Review process.--The review process for
502	certificates of need shall be as follows:
503	(5) ADMINISTRATIVE HEARINGS.--
504	(e) The agency shall issue its final order within 45 days
505	after receipt of the recommended order. If the agency fails to
506	take action within 45 days, the recommended order of the
507	Division of Administrative Hearings is deemed approvedsuch
508	time, or as otherwise agreed to by the applicant and the agency,
509	the applicant may take appropriate legal action to compel the
510	agency to act. When making a determination on an application for
511	a certificate of need, the agency is specifically exempt from
512	the time limitations provided in s. 120.60(1).
513	(6) JUDICIAL REVIEW.--
514	(c) The court, in its discretion, may award reasonable
515	attorney's fees and costs to the prevailing party if the court
516	finds that there was a complete absence of a justiciable issue
517	of law or fact raised by the losing party. If the losing party
518	is a hospital, the court shall order it to pay the reasonable
519	attorney's fees and costs, which shall include fees and costs
520	incurred as a result of the administrative hearing and the
521	judicial appeal, of the prevailing hospital party.
522	Section 6. Subsection (17) of section 400.021, Florida
523	Statutes, is amended to read:
524	400.021 Definitions.--When used in this part, unless the
525	context otherwise requires, the term:
526	(17) "Resident care plan" means a written plan developed,
527	maintained, and reviewed not less than quarterly by a registered
528	nurse, with participation from other facility staff and the
529	resident or his or her designee or legal representative, which
530	includes a comprehensive assessment of the needs of an
531	individual resident; the type and frequency of services required
532	to provide the necessary care for the resident to attain or
533	maintain the highest practicable physical, mental, and
534	psychosocial well-being; a listing of services provided within
535	or outside the facility to meet those needs; and an explanation
536	of service goals. The resident care plan must be signed by the
537	director of nursing or another registered nurse employed by the
538	facility to whom institutional responsibilities have been
539	delegated and bythe resident, the resident's designee, or the
540	resident's legal representative.
541	Section 7. Subsections (9) and (10) of section 400.121,
542	Florida Statutes, are amended to read:
543	400.121 Denial, suspension, revocation of license;
544	moratorium on admissions; administrative fines; procedure; order
545	to increase staffing.--
546	(9) Notwithstanding any other provision of law to the
547	contrary, agency action in an administrative proceeding under
548	this section may be overcome by the licensee upon a showing by a
549	preponderance of the evidence to the contrary.
550	(10)In addition to any other sanction imposed under this
551	part, in any final order that imposes sanctions, the agency may
552	assess costs related to the investigation and prosecution of the
553	case. Payment of agency costs shall be deposited into the Health
554	Care Trust Fund.
555	Section 8. Subsection (21) of section 400.141, Florida
556	Statutes, is amended to read:
557	400.141 Administration and management of nursing home
558	facilities.--Every licensed facility shall comply with all
559	applicable standards and rules of the agency and shall:
560	(21) Maintain in the medical record for each resident a
561	daily chart of certified nursing assistant services provided to
562	residents who are at high risk for malnutrition or dehydration
563	as ordered by the resident's physicianthe resident. The
564	certified nursing assistant who is caring for the resident must
565	complete this record by the end of his or her shift. This record
566	must indicate assistance with activities of daily living,
567	assistance with eating, and assistance with drinking, and must
568	record each offering of nutrition and hydration for those
569	residents whose plan of care or assessment indicates a risk for
570	malnutrition or dehydration.
571
572	Facilities that have been awarded a Gold Seal under the program
573	established in s. 400.235 may develop a plan to provide
574	certified nursing assistant training as prescribed by federal
575	regulations and state rules and may apply to the agency for
576	approval of their program.
577	Section 9. Section 400.147, Florida Statutes, is amended
578	to read:
579	400.147 Internal risk management and quality assurance
580	program.--
581	(1) Every facility shall, as part of its administrative
582	functions, establish an internal risk management and quality
583	assurance program, the purpose of which is to assess resident
584	care practices; review facility quality indicators, facility
585	incident reports, deficiencies cited by the agency, and resident
586	grievances; and develop plans of action to correct and respond
587	quickly to identified quality deficiencies. The program must
588	include:
589	(a) A designated person to serve as risk manager, who is
590	responsible for implementation and oversight of the facility's
591	risk management and quality assurance program as required by
592	this section.
593	(b) A risk management and quality assurance committee
594	consisting of the facility risk manager, the administrator, the
595	director of nursing, the medical director, and at least three
596	other members of the facility staff. The risk management and
597	quality assurance committee shall meet at least monthly.
598	(c) Policies and procedures to implement the internal risk
599	management and quality assurance program, which must include the
600	investigation and analysis of the frequency and causes of
601	general categories and specific types of adverse incidents to
602	residents.
603	(d) The development and implementation of an incident
604	reporting system based upon the affirmative duty of all health
605	care providers and all agents and employees of the licensed
606	health care facility to report adverse incidents to the risk
607	manager, or to his or her designee, within 3 business days after
608	their occurrence.
609	(e) The development of appropriate measures to minimize
610	the risk of adverse incidents to residents, including, but not
611	limited to, education and training in risk management and risk
612	prevention for all nonphysician personnel, as follows:
613	1. Such education and training of all nonphysician
614	personnel must be part of their initial orientation; and
615	2. At least 1 hour of such education and training must be
616	provided annually for all nonphysician personnel of the licensed
617	facility working in clinical areas and providing resident care.
618	(f) The analysis of resident grievances that relate to
619	resident care and the quality of clinical services.
620	(2) The internal risk management and quality assurance
621	program is the responsibility of the facility administrator.
622	(3) In addition to the programs mandated by this section,
623	other innovative approaches intended to reduce the frequency and
624	severity of adverse incidents to residents and violations of
625	residents' rights shall be encouraged and their implementation
626	and operation facilitated.
627	(4) Each internal risk management and quality assurance
628	program shall include the use of incident reports to be filed
629	with the risk manager and the facility administrator. The risk
630	manager shall have free access to all resident records of the
631	licensed facility. The incident reports are part of the
632	workpapers of the attorney defending the licensed facility in
633	litigation relating to the licensed facility and are subject to
634	discovery, but are not admissible as evidence in court. A person
635	filing an incident report is not subject to civil suit by virtue
636	of such incident report. As a part of each internal risk
637	management and quality assurance program, the incident reports
638	shall be used to develop categories of incidents which identify
639	problem areas. Once identified, procedures shall be adjusted to
640	correct the problem areas.
641	(5) For purposes of reporting to the agency under this
642	section, the term "adverse incident" means:
643	(a)an event over which facility personnel could exercise
644	control and which is associated in whole or in part with the
645	facility's intervention, rather than the condition for which
646	such intervention occurred, and which results in one of the
647	following injuries:
648	(a)1.Death;
649	(b)2.Brain or spinal damage;
650	(c)3.Permanent disfigurement;
651	(d)4.Fracture or dislocation of bones or joints;
652	(e)5. A resultinglimitation of neurological, physical, or
653	sensory function which is expected to be irreversible;
654	(f)6. Any injuriouscondition that required medical
655	attention to which the resident has not given his or her
656	informed consent, including failure to honor advanced
657	directives; or
658	(g)7.Any condition that required the transfer of the
659	resident, within or outside the facility, to a unit providing a
660	more acute level of care due to the adverse incident, rather
661	than the resident's condition prior to the adverse incident;
662	(b) Abuse, neglect, or exploitation as defined in s.
663	415.102;
664	(c) Abuse, neglect and harm as defined in s. 39.01;
665	(d) Resident elopement; or
666	(e) An event that is reported to law enforcement.
667	(6) The internal risk manager of each licensed facility
668	shall:
669	(a) Investigate every allegation of sexual misconduct
670	which is made against a member of the facility's personnel who
671	has direct patient contact when the allegation is that the
672	sexual misconduct occurred at the facility or at the grounds of
673	the facility.;
674	(b) Report every allegation of sexual misconduct to the
675	administrator of the licensed facility.; and
676	(c) Notify the resident representative or guardian of the
677	victim that an allegation of sexual misconduct has been made and
678	that an investigation is being conducted.
679	(7) The facility shall initiate an investigation and shall
680	notify the agency within 1 business day after the risk manager
681	or his or her designee has received a report pursuant to
682	paragraph (1)(d). The notification must be made in writing and
683	be provided electronically, by facsimile device or overnight
684	mail delivery. The notification must include information
685	regarding the identity of the affected resident, the type of
686	adverse incident, the initiation of an investigation by the
687	facility, and whether the events causing or resulting in the
688	adverse incident represent a potential risk to any other
689	resident. The notification is confidential as provided by law
690	and is not discoverable or admissible in any civil or
691	administrative action, except in disciplinary proceedings by the
692	agency or the appropriate regulatory board. The agency may
693	investigate, as it deems appropriate, any such incident and
694	prescribe measures that must or may be taken in response to the
695	incident. The agency shall review each incident and determine
696	whether it potentially involved conduct by the health care
697	professional who is subject to disciplinary action, in which
698	case the provisions of s. 456.073 shall apply.
699	(7)(8)(a) Each facility shall complete the investigation
700	and submit an adverse incident report to the agency for each
701	adverse incident within 15 calendar days after its occurrence.
702	If, after a complete investigation, the risk manager determines
703	that the incident was not an adverse incident as defined in
704	subsection (5), the facility shall include this information in
705	the report. The agency shall develop a form for reporting this
706	information.
707	(b) The information reported to the agency pursuant to
708	paragraph (a) which relates to persons licensed under chapter
709	458, chapter 459, chapter 461, or chapter 466 shall be reviewed
710	by the agency. The agency shall determine whether any of the
711	incidents potentially involved conduct by a health care
712	professional who is subject to disciplinary action, in which
713	case the provisions of s. 456.073 shall apply.
714	(c) The report submitted to the agency must also contain
715	the name of the risk manager of the facility.
716	(d) The adverse incident report is confidential as
717	provided by law and is not discoverable or admissible in any
718	civil or administrative action, except in disciplinary
719	proceedings by the agency or the appropriate regulatory board.
720	(8)(9)By the 10th of each month, each facility subject to
721	this section shall report any notice received pursuant to s.
722	400.0233(2) and each initial complaint that was filed with the
723	clerk of the court and served on the facility during the
724	previous month by a resident or a resident's family member,
725	guardian, conservator, or personal legal representative. The
726	report must include the name of the resident, the resident's
727	date of birth and social security number, the Medicaid
728	identification number for Medicaid-eligible persons, the date or
729	dates of the incident leading to the claim or dates of
730	residency, if applicable, and the type of injury or violation of
731	rights alleged to have occurred. Each facility shall also submit
732	a copy of the notices received pursuant to s. 400.0233(2) and
733	complaints filed with the clerk of the court. This report is
734	confidential as provided by law and is not discoverable or
735	admissible in any civil or administrative action, except in such
736	actions brought by the agency to enforce the provisions of this
737	part.
738	(9)(10)The agency shall review, as part of its licensure
739	inspection process, the internal risk management and quality
740	assurance program at each facility regulated by this section to
741	determine whether the program meets standards established in
742	statutory laws and rules, is being conducted in a manner
743	designed to reduce adverse incidents, and is appropriately
744	reporting incidents as required by this section.
745	(10)(11)There is no monetary liability on the part of,
746	and a cause of action for damages may not arise against, any
747	risk manager for the implementation and oversight of the
748	internal risk management and quality assurance program in a
749	facility licensed under this part as required by this section,
750	or for any act or proceeding undertaken or performed within the
751	scope of the functions of such internal risk management and
752	quality assurance program if the risk manager acts without
753	intentional fraud.
754	(11)(12)If the agency, through its receipt of the adverse
755	incident reports pursuant toprescribed in subsection (7),or
756	through any investigation, has a reasonable belief that conduct
757	by a staff member or employee of a facility is grounds for
758	disciplinary action by the appropriate regulatory board, the
759	agency shall report this fact to the regulatory board. The
760	agency must use the report required under subsection (7) to
761	fulfill this reporting requirement. This subsection does not
762	require dual reporting nor additional, new documentation and
763	reporting by the facility to the appropriate regulatory board.
764	(12)(13)The agency may adopt rules to administer this
765	section.
766	(13)(14)The agency shall annually submit to the
767	Legislature a report on nursing home adverse incidents. The
768	report must include the following information arranged by
769	county:
770	(a) The total number of adverse incidents.
771	(b) A listing, by category, of the types of adverse
772	incidents, the number of incidents occurring within each
773	category, and the type of staff involved.
774	(c) A listing, by category, of the types of injury caused
775	and the number of injuries occurring within each category.
776	(d) Types of liability claims filed based on an adverse
777	incident or reportable injury.
778	(e) Disciplinary action taken against staff, categorized
779	by type of staff involved.
780	(14)(15)Information gathered by a credentialing
781	organization under a quality assurance program is not
782	discoverable from the credentialing organization. This
783	subsection does not limit discovery of, access to, or use of
784	facility records, including those records from which the
785	credentialing organization gathered its information.
786	Section 10. Subsections (3) and (4) of section 400.19,
787	Florida Statutes, are amended to read:
788	400.19 Right of entry and inspection.--
789	(3) The agency shall every 15 months conduct at least one
790	unannounced inspection to determine compliance by the licensee
791	with statutes, and with rules promulgated under the provisions
792	of those statutes, governing minimum standards of construction,
793	quality and adequacy of care, and rights of residents. The
794	survey shall be conducted every 6 months for the next 2-year
795	period if it is determined by final agency action thatthe
796	facility has been cited for a class I deficiency, has been cited
797	fortwo or more class II deficiencies arising from separate
798	surveys or investigations within a 60-day period, or has had
799	three or more substantiated complaints within a 6-month period,
800	each resulting in at least one class I or class II deficiency.
801	In addition to any other fees or fines in this part, the agency
802	shall assess a fine for each facility that is subject to the 6-
803	month survey cycle. The fine for the 2-year period shall be
804	$6,000, one-half to be paid at the completion of each survey.
805	The agency may adjust this fine by the change in the Consumer
806	Price Index, based on the 12 months immediately preceding the
807	increase, to cover the cost of the additional surveys. The
808	agency shall verify through subsequent inspection that any
809	deficiency identified during the annual inspection is corrected.
810	However, the agency may verify the correction of a class III or
811	class IV deficiency unrelated to resident rights or resident
812	care without reinspecting the facility if adequate written
813	documentation has been received from the facility, which
814	provides assurance that the deficiency has been corrected. The
815	giving or causing to be given of advance notice of such
816	unannounced inspections by an employee of the agency to any
817	unauthorized person shall constitute cause for suspension of not
818	fewer than 5 working days according to the provisions of chapter
819	110.
820	(4) The agency shall conduct unannounced onsite facility
821	reviews following written verification of licensee noncompliance
822	in instances in which a long-term care ombudsman council,
823	pursuant to ss. 400.0071 and 400.0075, has received a complaint
824	and has documented deficiencies in resident care or in the
825	physical plant of the facility that threaten the health, safety,
826	or security of residents, or when the agency documents through
827	inspection that conditions in a facility present a direct or
828	indirect threat to the health, safety, or security of residents.
829	However, the agency shall conduct unannounced onsite reviews
830	every 3 months of each facility while the facility has a
831	conditional license as a result of final agency action.
832	Deficiencies related to physical plant do not require followup
833	reviews after the agency has determined that correction of the
834	deficiency has been accomplished and that the correction is of
835	the nature that continued compliance can be reasonably expected.
836	Section 11. Paragraph (d) of subsection (1) of section
837	400.195, Florida Statutes, is amended to read:
838	400.195 Agency reporting requirements.--
839	(1) For the period beginning June 30, 2001, and ending
840	June 30, 2005, the Agency for Health Care Administration shall
841	provide a report to the Governor, the President of the Senate,
842	and the Speaker of the House of Representatives with respect to
843	nursing homes. The first report shall be submitted no later than
844	December 30, 2002, and subsequent reports shall be submitted
845	every 6 months thereafter. The report shall identify facilities
846	based on their ownership characteristics, size, business
847	structure, for-profit or not-for-profit status, and any other
848	characteristics the agency determines useful in analyzing the
849	varied segments of the nursing home industry and shall report:
850	(d) Information regarding deficiencies cited, including
851	information used to develop the Nursing Home Guide WATCH LIST
852	pursuant to s. 400.191, and applicable rules, a summary of data
853	generated on nursing homes by Centers for Medicare and Medicaid
854	Services Nursing Home Quality Information Project, and
855	information collected pursuant to s. 400.147(8)(9), relating to
856	litigation.
857	Section 12. Subsection (4) of section 400.211, Florida
858	Statutes, is amended to read:
859	400.211 Persons employed as nursing assistants;
860	certification requirement.--
861	(4) When employed by a nursing home facility for a 12-
862	month period or longer, a nursing assistant, to maintain
863	certification, shall submit to a performance review every 12
864	months and must receive regular inservice education based on the
865	outcome of such reviews. The inservice training must:
866	(a) Be sufficient to ensure the continuing competence of
867	nursing assistants and must meet the standard specified in s.
868	464.203(7)., must be at least 18 hours per year, and may include
869	hours accrued under s. 464.203(8);
870	(b) Include, at a minimum:
871	1. Techniques for assisting with eating and proper
872	feeding.;
873	2. Principles of adequate nutrition and hydration.;
874	3. Techniques for assisting and responding to the
875	cognitively impaired resident or the resident with difficult
876	behaviors.;
877	4. Techniques for caring for the resident at the end-of-
878	life.; and
879	5. Recognizing changes that place a resident at risk for
880	pressure ulcers and falls.; and
881	(c) Address areas of weakness as determined in nursing
882	assistant performance reviews and may address the special needs
883	of residents as determined by the nursing home facility staff.
884
885	Costs associated with thethis training required by this
886	subsectionmay not be reimbursed from additional Medicaid
887	funding through interim rate adjustments.
888	Section 13. Paragraphs (b) and (e) of subsection (7) and
889	subsection (8) of section 400.23, Florida Statutes, are amended,
890	and subsection (10) is added to said section, to read:
891	400.23 Rules; evaluation and deficiencies; licensure
892	status.--
893	(7) The agency shall, at least every 15 months, evaluate
894	all nursing home facilities and make a determination as to the
895	degree of compliance by each licensee with the established rules
896	adopted under this part as a basis for assigning a licensure
897	status to that facility. The agency shall base its evaluation on
898	the most recent inspection report, taking into consideration
899	findings from other official reports, surveys, interviews,
900	investigations, and inspections. The agency shall assign a
901	licensure status of standard or conditional to each nursing
902	home.
903	(b) A conditional licensure status means that a facility,
904	due to the presence of one or more class I or class II
905	deficiencies, or class III deficiencies not corrected within the
906	time established by the agency, is not in substantial compliance
907	at the time of the survey with criteria established under this
908	part or with rules adopted by the agency. If the facility has no
909	class I, class II, or uncorrectedclass III deficiencies at the
910	time of the followup survey, a standard licensure status shall
911	maybe assigned.
912	(e) Each licensee shall post its license, pursuant to
913	final agency action,in a prominent place that is in clear and
914	unobstructed public view at or near the place where residents
915	are being admitted to the facility.
916	(8) The agency shall adopt rules to provide that, when the
917	criteria established under subsection (2) are not met, such
918	deficiencies shall be classified according to the nature and the
919	scope of the deficiency. The scope shall be cited as isolated,
920	patterned, or widespread. An isolated deficiency is a deficiency
921	affecting one or a very limited number of residents, or
922	involving one or a very limited number of staff, or a situation
923	that occurred only occasionally or in a very limited number of
924	locations. A patterned deficiency is a deficiency where more
925	than a very limited number of residents are affected, or more
926	than a very limited number of staff are involved, or the
927	situation has occurred in several locations, or the same
928	resident or residents have been affected by repeated occurrences
929	of the same deficient practice but the effect of the deficient
930	practice is not found to be pervasive throughout the facility. A
931	widespread deficiency is a deficiency in which the problems
932	causing the deficiency are pervasive in the facility or
933	represent systemic failure that has affected or has the
934	potential to affect a large portion of the facility's residents.
935	The agency shall indicate the classification on the face of the
936	notice of deficiencies as follows:
937	(a) A class I deficiency is a deficiency that the agency
938	determines presents a situation in which immediate corrective
939	action is necessary because the facility's noncompliance creates
940	immediate jeopardy to residents' health or safety. "Immediate
941	jeopardy" exists when the licensee's noncompliancehas caused,
942	or is likely to cause, serious injury, harm, impairment, or
943	death to a resident receiving care in a facility. The condition
944	or practice constituting a class I violation shall be abated or
945	eliminated immediately, unless a fixed period of time, as
946	determined by the agency, is required for correction. A class I
947	deficiency is subject to a civil penalty of $10,000 for an
948	isolated deficiency, $12,500 for a patterned deficiency, and
949	$15,000 for a widespread deficiency. The fine amount shall be
950	doubled for each deficiency if the facility was previously cited
951	for one or more class I or class II deficiencies during the last
952	annual inspection or any inspection or complaint investigation
953	since the last annual inspection. A fine must be levied
954	notwithstanding the correction of the deficiency.
955	(b) A class II deficiency is a deficiency that the agency
956	determines has caused actual harm to a resident which is not
957	immediate jeopardycompromised the resident's ability to
958	maintain or reach his or her highest practicable physical,
959	mental, and psychosocial well-being, as defined by an accurate
960	and comprehensive resident assessment, plan of care, and
961	provision of services. A class II deficiency is subject to a
962	civil penalty of $2,500 for an isolated deficiency, $5,000 for a
963	patterned deficiency, and $7,500 for a widespread deficiency.
964	The fine amount shall be doubled for each deficiency if the
965	facility was previously cited for one or more class I or class
966	II deficiencies during the last annual inspection or any
967	inspection or complaint investigation since the last annual
968	inspection. A fine shall be levied notwithstanding the
969	correction of the deficiency.
970	(c) A class III deficiency is a deficiency that the agency
971	determines has not caused actual harm to residents but presents
972	the potential for more than minimal harm that is not immediate
973	jeopardywill result in no more than minimal physical, mental,
974	or psychosocial discomfort to the resident or has the potential
975	to compromise the resident's ability to maintain or reach his or
976	her highest practical physical, mental, or psychosocial well-
977	being, as defined by an accurate and comprehensive resident
978	assessment, plan of care, and provision of services. A class III
979	deficiency is subject to a civil penalty of $1,000 for an
980	isolated deficiency, $2,000 for a patterned deficiency, and
981	$3,000 for a widespread deficiency. The fine amount shall be
982	doubled for each deficiency if the facility was previously cited
983	for one or more class I or class II deficiencies during the last
984	annual inspection or any inspection or complaint investigation
985	since the last annual inspection. A citation for a class III
986	deficiency must specify the time within which the deficiency is
987	required to be corrected. If a class III deficiency is corrected
988	within the time specified, no civil penalty shall be imposed.
989	(d) A class IV deficiency is a deficiency that the agency
990	determines has the potential for causing no more than minimal
991	harm toa minor negative impact onthe resident. If the class IV
992	deficiency is isolated, no plan of correction is required.
993	(10) Agency records, reports, ranking systems, Internet
994	information, and publications must reflect final agency actions.
995	Section 14. Section 400.244, Florida Statutes, is created
996	to read:
997	400.244 Alternative uses of nursing home beds; funding
998	limitations; applicable codes and requirements; procedures;
999	reconversion.--
1000	(1) It is the intent of the Legislature to allow nursing
1001	home facilities to use licensed nursing home facility beds for
1002	alternative uses other than nursing home care for extended
1003	periods of time exceeding 48 hours.
1004	(2) A nursing home may use a contiguous portion of the
1005	nursing home facility to meet the needs of the elderly through
1006	the use of less restrictive and less institutional methods of
1007	long-term care, including, but not limited to, adult day care,
1008	assisted living, extended congregate care, or limited nursing
1009	services.
1010	(3) Funding under assisted-living Medicaid waivers for
1011	nursing home facility beds that are used to provide extended
1012	congregate care or limited nursing services under this section
1013	may be provided only for residents who have resided in the
1014	nursing home facility for a minimum of 90 consecutive days.
1015	(4) Nursing home facility beds that are used in providing
1016	alternative services may share common areas, services, and staff
1017	with beds that are designated for nursing home care. Fire codes
1018	and life safety codes applicable to nursing home facilities also
1019	apply to beds used for alternative purposes under this section.
1020	Any alternative use must meet other requirements specified by
1021	law for that use.
1022	(5) In order to take beds out of service for nursing home
1023	care and use them to provide alternative services under this
1024	section, a nursing home must submit a written request for
1025	approval to the Agency for Health Care Administration in a
1026	format specified by the agency. The agency shall approve the
1027	request unless it determines that such action will adversely
1028	affect access to nursing home care in the geographical area in
1029	which the nursing home is located. The agency shall, in its
1030	review, consider a district average occupancy of 94 percent or
1031	greater at the time of the application as an indicator of an
1032	adverse impact. The agency shall review the request for
1033	alternative use at each annual license renewal.
1034	(6) A nursing home facility that converts beds to an
1035	alternative use under this section retains its license for all
1036	of the nursing home facility beds and may return those beds to
1037	nursing home operation upon 60 days' advance notice to the
1038	agency unless notice requirements are specified elsewhere in
1039	law. The nursing home facility shall continue to pay all
1040	licensure fees as required by s. 400.062 and applicable rules
1041	but is not required to pay any other state licensure fee for the
1042	alternative service.
1043	(7) Within 45 days after the end of each calendar quarter,
1044	each facility that has nursing facility beds licensed under this
1045	chapter shall report to the agency or its designee the total
1046	number of patient days which occurred in each month of the
1047	quarter and the number of such days which were Medicaid patient
1048	days.
1049	Section 15. Hospital Statutory and Regulatory Reform
1050	Council; legislative intent; creation; membership; duties.--
1051	(1) It is the intent of the Legislature to provide for the
1052	protection of the public health and safety in the establishment,
1053	construction, maintenance, and operation of hospitals. However,
1054	the Legislature further intends that the police power of the
1055	state be exercised toward that purpose only to the extent
1056	necessary and that regulation remain current with the ever-
1057	changing standard of care and not restrict the introduction and
1058	use of new medical technologies and procedures.
1059	(2) In order to achieve the purposes expressed in
1060	subsection (1), it is necessary that the state establish a
1061	mechanism for the ongoing review and updating of laws regulating
1062	hospitals. The Hospital Statutory and Regulatory Reform Council
1063	is created and located, for administrative purposes only, within
1064	the Agency for Health Care Administration. The council shall
1065	consist of no more than 15 members, including:
1066	(a) Nine members appointed by the Florida Hospital
1067	Association who represent acute care, teaching, specialty,
1068	rural, government-owned, for-profit, and not-for-profit
1069	hospitals.
1070	(b) Two members appointed by the Governor who represent
1071	patients.
1072	(c) Two members appointed by the President of the Senate
1073	who represent private businesses that provide health insurance
1074	coverage for their employees, one of whom represents small
1075	private businesses and one of whom represents large private
1076	businesses. As used in this paragraph, the term "private
1077	business" does not include an entity licensed under chapter 627,
1078	Florida Statutes, or chapter 641, Florida Statutes, or otherwise
1079	licensed or authorized to provide health insurance services,
1080	either directly or indirectly, in this state.
1081	(d) Two members appointed by the Speaker of the House
1082	of Representatives who represent physicians.
1083	(3) Council members shall be appointed to serve 2-year
1084	terms and may be reappointed. A member shall serve until his or
1085	her successor is appointed. The council shall annually elect
1086	from among its members a chair and a vice chair. The council
1087	shall meet at least twice a year and shall hold additional
1088	meetings as it considers necessary. Members appointed by the
1089	Florida Hospital Association may not receive compensation or
1090	reimbursement of expenses for their services. Members appointed
1091	by the Governor, the President of the Senate, or the Speaker of
1092	the House of Representatives may be reimbursed for travel
1093	expenses by the agency.
1094	(4) The council, as its first priority, shall review
1095	chapters 395 and 408, Florida Statutes, and shall make
1096	recommendations to the Legislature for the repeal of regulatory
1097	provisions that are no longer necessary or that fail to promote
1098	cost-efficient, high-quality medicine.
1099	(5) The council, as its second priority, shall recommend
1100	to the Secretary of Health and the Secretary of Health Care
1101	Administration regulatory changes relating to hospital licensure
1102	and regulation to assist the Department of Health and the Agency
1103	for Health Care Administration in carrying out their duties and
1104	to ensure that the intent of the Legislature as expressed in
1105	this section is carried out.
1106	(6) In determining whether a statute or rule is
1107	appropriate or necessary, the council shall consider whether:
1108	(a) The statute or rule is necessary to prevent
1109	substantial harm, which is recognizable and not remote, to the
1110	public health, safety, or welfare.
1111	(b) The statute or rule restricts the use of new medical
1112	technologies or encourages the implementation of more cost-
1113	effective medical procedures.
1114	(c) The statute or rule has an unreasonable effect on job
1115	creation or job retention in the state.
1116	(d) The public is or can be effectively protected by other
1117	means.
1118	(e) The overall cost-effectiveness and economic effect of
1119	the proposed statute or rule, including the indirect costs to
1120	consumers, will be favorable.
1121	(f) A lower-cost regulatory alternative to the statute or
1122	rule could be adopted.
1123	Section 16. This act shall take effect July 1, 2003.