HB 0329

1	A bill to be entitled
2	An act relating to certificate of need; amending s.
3	395.003, F.S.; providing additional conditions for the
4	licensure or relicensure of hospitals; exempting currently
5	licensed hospitals; amending s. 408.032, F.S.; redefining
6	terms relating to the Health Facility and Services
7	Development Act; deleting the term "regional area";
8	amending s. 408.033, F.S.; deleting provisions relating to
9	regional area health plans; transferring certain duties
10	from the Agency for Health Care Administration to the
11	Department of Health; deleting an agency responsibility
12	relating to orientation of local health council members;
13	deleting a requirement that local health councils be
14	partly funded by application fees for certificates of
15	need; adding sources of funding for local health councils;
16	amending s. 408.034, F.S.; revising criteria for
17	certificate-of-need review and for issuing licenses to
18	health care facilities and health service providers;
19	revising criteria for the nursing-home-bed-need
20	methodology; amending s. 408.035, F.S.; revising the
21	criteria for reviewing applications for certificate-of-
22	need determinations; amending s. 408.036, F.S.; revising
23	criteria for determining whether a health-care-related
24	project is subject to review; providing that the
25	replacement or relocation of a nursing home is subject to
26	expedited review under specified conditions; revising the
27	criteria for determining whether a project is subject to
28	exemption from review upon request; repealing the
29	exemption for specified services; adding an optional
30	exemption for neonatal intensive care units that meet
31	certain requirements; providing exemptions for adding beds
32	for comprehensive rehabilitation, for beds in state mental
33	health treatment facilities, for beds in state mental
34	health treatment facilities and state mental health
35	forensic facilities, and for beds in state developmental
36	services institutions; revising the criteria for optional
37	exemption of adult open-heart services; requiring the
38	agency to report annually to the Legislature specified
39	information concerning exemptions requested and granted
40	during the preceding calendar year; adding an optional
41	exemption for the provision of percutaneous coronary
42	intervention under certain conditions; requiring health
43	care facilities and providers to provide to the agency
44	notice of the replacement of a health care facility or a
45	nursing home, in specified circumstances, consolidation of
46	nursing homes, the termination of a health care service,
47	and the addition or delicensure of beds; amending s.
48	408.0361, F.S., relating to compliance with requirements
49	imposed on diagnostic cardiac catheterization services
50	providers; revising the scope of application, to include
51	the compliance required of cardiology services and the
52	licensure of burn units; requiring the Secretary of Health
53	Care Administration to appoint an advisory group to study
54	replacing certificate-of-need review of organ transplant
55	programs with licensure regulation of organ transplant
56	providers; requiring a report to the secretary and the
57	Legislature; requiring the secretary to appoint a work
58	group to study certificate-of-need regulation and changing
59	market conditions related to the supply and distribution
60	of hospital beds; requiring a report to the secretary and
61	the Legislature; amending s. 408.038, F.S.; revising fees
62	assessed on certificate-of-need applications; amending s.
63	408.039, F.S.; revising the review process for
64	certificates of need; requiring shorter review cycles;
65	deleting a requirement to file a copy of the application
66	with the local health council; deleting a requirement to
67	consider the district health plan in reviewing and taking
68	action on the applications; amending s. 408.040, F.S.;
69	applying the conditions to the issuance of a certificate
70	of need to the issuance of an exemption; providing that
71	certain failures to annually report compliance with
72	certain conditions to receiving a certificate of need or
73	an exemption constitute noncompliance; repealing s.
74	408.043(5), F.S., relating to the authority of a sole
75	acute care hospital in a high growth county to add beds
76	without agency review; amending s. 408.0455, F.S.;
77	providing for the rules of the agency which are in effect
78	on June 30, 2004, rather than those in effect on June 30,
79	1997, to remain in effect; providing for severability;
80	amending s. 52, ch. 2001-45, Laws of Florida, as amended;
81	specifying nonapplication of moratoriums on certificates
82	of need and authorizing approval of certain certificates
83	of need for certain counties under certain circumstances;
84	providing review requirements and bed limitations;
85	providing for future expiration of the moratoriums;
86	providing an effective date.
87
88	WHEREAS, appropriate access to adult cardiac care is an
89	issue of critical state importance to all residents of the state
90	and to all health service planning districts of the state, and
91	WHEREAS, the certificate-of-need process, for most
92	geographic areas in the state, has provided adequate access to
93	adult open-heart-surgery services to Floridians as well as
94	tourists, business travelers, indigents, and migrant workers who
95	receive such services, and
96	WHEREAS, the number of adult open-heart-surgery programs in
97	certain health service planning districts has not kept pace with
98	the dramatic increase in population in those areas, and
99	WHEREAS, there have been numerous technological advances in
100	the area of primary angioplasty and stent procedures known
101	collectively as percutaneous coronary interventions, and these
102	advanced interventional treatments provide the highest standard
103	of care for people suffering acute myocardial infarctions, and
104	WHEREAS, the success of these interventional treatments
105	requires immediate access (within 1 hour) to hospitals having
106	interventional technology and a backup open-heart-surgery
107	program, and
108	WHEREAS, hospitals that cannot perform percutaneous
109	coronary interventions must resort to the use of thrombolytics,
110	a less effective treatment in many instances, and therefore
111	adults in need of percutaneous coronary interventions are being
112	denied these procedures due to lack of access, and
113	WHEREAS, diagnosis; discharge from the transferring
114	hospital; transfer arrangements, including, but not limited to,
115	insurance and administrative approval; transportation
116	availability; admission to the receiving hospital; staff
117	availability at the receiving hospital; and, most importantly,
118	bed availability at the receiving hospital as well as travel
119	delays to the receiving hospital contribute to the time taken to
120	effectuate a transfer of a cardiac patient, and
121	WHEREAS, the Legislature finds that timely access and
122	availability for every adult in this state, regardless of
123	socioeconomic class or geographic location, to these
124	interventional treatments and open-heart surgery is of critical
125	state concern, especially because myocardial infarctions and
126	related coronary disease are no respecters of location or time,
127	and
128	WHEREAS, to ensure that it provides the quality of care
129	desired, each hospital that qualifies for the exemption provided
130	by this act will be subject to more stringent criteria and will
131	also be subject to continual monitoring by the Agency for Health
132	Care Administration, and
133	WHEREAS, the Legislature intends to ensure that standards
134	of quality are maintained while promoting competition in the
135	provision of adult cardiac care, NOW, THEREFORE,
136
137	Be It Enacted by the Legislature of the State of Florida:
138
139	Section 1.  Subsections (9), (10), and (11) are added to
140	section 395.003, Florida Statutes, to read:
141	395.003  Licensure; issuance, renewal, denial,
142	modification, suspension, and revocation.--
143	(9)  A hospital may not be licensed or relicensed if:
144	(a)  The diagnosis-related groups for 65 percent or more of
145	the discharges from the hospital, in the most recent year for
146	which data is available to the Agency for Health Care
147	Administration pursuant to s. 408.061, are for diagnosis, care,
148	and treatment of patients who have:
149	1.  Cardiac-related diseases and disorders classified as
150	diagnosis-related groups 103-145, 478-479, 514-518, or 525-527;
151	2.  Orthopedic-related diseases and disorders classified as
152	diagnosis-related groups 209-256, 471, 491, 496-503, or 519-520;
153	3.  Cancer-related diseases and disorders classified as
154	diagnosis-related groups 64, 82, 172, 173, 199, 200, 203, 257-
155	260, 274, 275, 303, 306, 307, 318, 319, 338, 344, 346, 347, 363,
156	366, 367, 400-414, 473, or 492; or
157	4.  Any combination of the above discharges.
158	(b)  The hospital restricts its medical and surgical
159	services to primarily or exclusively cardiac, orthopedic,
160	surgical, or oncology specialties.
161	(10)  A hospital licensed as of June 1, 2004, shall be
162	exempt from subsection (9) as long as the hospital maintains the
163	same ownership, facility street address, and range of services
164	that were in existence on June 1, 2004. Any transfer of beds, or
165	other agreements that result in the establishment of a hospital
166	or hospital services within the intent of this section, shall be
167	subject to subsection (9). Unless the hospital is otherwise
168	exempt under subsection (9), the agency shall deny or revoke the
169	license of a hospital that violates any of the criteria set
170	forth in that subsection.
171	(11)  The agency may adopt rules implementing the licensure
172	requirements set forth in subsection (9). Within 14 days after
173	rendering its decision on a license application or revocation,
174	the agency shall publish its proposed decision in the Florida
175	Administrative Weekly. Within 21 days after publication of the
176	agency's decision, any authorized person may file a request for
177	an administrative hearing. In administrative proceedings
178	challenging the approval, denial, or revocation of a license
179	pursuant to subsection (9), the hearing must be based on the
180	facts and law existing at the time of the agency's proposed
181	agency action. Existing hospitals may initiate or intervene in
182	an administrative hearing to approve, deny, or revoke licensure
183	under subsection (9) based upon a showing that an established
184	program will be substantially affected by the issuance or
185	renewal of a license to a hospital within the same district or
186	service area.
187	Section 2.  Subsections (9), (13), and (17) of section
188	408.032, Florida Statutes, are amended, and subsection (18) of
189	that section is repealed, to read:
190	408.032  Definitions relating to Health Facility and
191	Services Development Act.--As used in ss. 408.031-408.045, the
192	term:
193	(9)  "Health services" means inpatient diagnostic,
194	curative, or comprehensive medical rehabilitative services and
195	includes mental health services. Obstetric services are not
196	health services for purposes of ss. 408.031-408.045.
197	(13)  "Long-term care hospital" means a hospital licensed
198	under chapter 395 which meets the requirements of 42 C.F.R. s.
199	412.23(e) and seeks exclusion from the acute care Medicare
200	prospective payment system for inpatient hospital services.
201	(17)  "Tertiary health service" means a health service
202	which, due to its high level of intensity, complexity,
203	specialized or limited applicability, and cost, should be
204	limited to, and concentrated in, a limited number of hospitals
205	to ensure the quality, availability, and cost-effectiveness of
206	such service. Examples of such service include, but are not
207	limited to, pediatric cardiac catheterization, pediatric open-
208	heart surgery, organ transplantation, specialty burn units,
209	neonatal intensive care units, comprehensive rehabilitation, and
210	medical or surgical services which are experimental or
211	developmental in nature to the extent that the provision of such
212	services is not yet contemplated within the commonly accepted
213	course of diagnosis or treatment for the condition addressed by
214	a given service.  The agency shall establish by rule a list of
215	all tertiary health services.
216	(18)  "Regional area" means any of those regional health
217	planning areas established by the agency to which local and
218	district health planning funds are directed to local health
219	councils through the General Appropriations Act.
220	Section 3.  Section 408.033, Florida Statutes, is amended
221	to read:
222	408.033  Local and state health planning.--
223	(1)  LOCAL HEALTH COUNCILS.--
224	(a)  Local health councils are hereby established as public
225	or private nonprofit agencies serving the counties of a district
226	or regional area of the agency. The members of each council
227	shall be appointed in an equitable manner by the county
228	commissions having jurisdiction in the respective district. Each
229	council shall be composed of a number of persons equal to 1 1/2
230	times the number of counties which compose the district or 12
231	members, whichever is greater. Each county in a district shall
232	be entitled to at least one member on the council. The balance
233	of the membership of the council shall be allocated among the
234	counties of the district on the basis of population rounded to
235	the nearest whole number; except that in a district composed of
236	only two counties, no county shall have fewer than four members.
237	The appointees shall be representatives of health care
238	providers, health care purchasers, and nongovernmental health
239	care consumers, but not excluding elected government officials.
240	The members of the consumer group shall include a representative
241	number of persons over 60 years of age. A majority of council
242	members shall consist of health care purchasers and health care
243	consumers.  The local health council shall provide each county
244	commission a schedule for appointing council members to ensure
245	that council membership complies with the requirements of this
246	paragraph.  The members of the local health council shall elect
247	a chair. Members shall serve for terms of 2 years and may be
248	eligible for reappointment.
249	(b)  Each local health council may:
250	1.  Develop a district or regional area health plan that
251	permits each local health council to develop strategies and set
252	priorities for implementation based on its unique local health
253	needs. The district or regional area health plan must contain
254	preferences for the development of health services and
255	facilities, which may be considered by the agency in its review
256	of certificate-of-need applications.  The district health plan
257	shall be submitted to the agency and updated periodically. The
258	district health plans shall use a uniform format and be
259	submitted to the agency according to a schedule developed by the
260	agency in conjunction with the local health councils. The
261	schedule must provide for the development of district health
262	plans by major sections over a multiyear period.  The elements
263	of a district plan which are necessary to the review of
264	certificate-of-need applications for proposed projects within
265	the district may be adopted by the agency as a part of its
266	rules.
267	2.  Advise the agency on health care issues and resource
268	allocations.
269	3.  Promote public awareness of community health needs,
270	emphasizing health promotion and cost-effective health service
271	selection.
272	4.  Collect data and conduct analyses and studies related
273	to health care needs of the district, including the needs of
274	medically indigent persons, and assist the agency and other
275	state agencies in carrying out data collection activities that
276	relate to the functions in this subsection.
277	5.  Monitor the onsite construction progress, if any, of
278	certificate-of-need approved projects and report council
279	findings to the agency on forms provided by the agency.
280	6.  Advise and assist any regional planning councils within
281	each district that have elected to address health issues in
282	their strategic regional policy plans with the development of
283	the health element of the plans to address the health goals and
284	policies in the State Comprehensive Plan.
285	7.  Advise and assist local governments within each
286	district on the development of an optional health plan element
287	of the comprehensive plan provided in chapter 163, to assure
288	compatibility with the health goals and policies in the State
289	Comprehensive Plan and district health plan.  To facilitate the
290	implementation of this section, the local health council shall
291	annually provide the local governments in its service area, upon
292	request, with:
293	a.  A copy and appropriate updates of the district health
294	plan;
295	b.  A report of hospital and nursing home utilization
296	statistics for facilities within the local government
297	jurisdiction; and
298	c.  Applicable agency rules and calculated need
299	methodologies for health facilities and services regulated under
300	s. 408.034 for the district served by the local health council.
301	8.  Monitor and evaluate the adequacy, appropriateness, and
302	effectiveness, within the district, of local, state, federal,
303	and private funds distributed to meet the needs of the medically
304	indigent and other underserved population groups.
305	9.  In conjunction with the Department of Health Agency for
306	Health Care Administration, plan for services at the local level
307	for persons infected with the human immunodeficiency virus.
308	10.  Provide technical assistance to encourage and support
309	activities by providers, purchasers, consumers, and local,
310	regional, and state agencies in meeting the health care goals,
311	objectives, and policies adopted by the local health council.
312	11.  Provide the agency with data required by rule for the
313	review of certificate-of-need applications and the projection of
314	need for health services and facilities in the district.
315	(c)  Local health councils may conduct public hearings
316	pursuant to s. 408.039(3)(b).
317	(d)  Each local health council shall enter into a
318	memorandum of agreement with each regional planning council in
319	its district that elects to address health issues in its
320	strategic regional policy plan.  In addition, each local health
321	council shall enter into a memorandum of agreement with each
322	local government that includes an optional health element in its
323	comprehensive plan. Each memorandum of agreement must specify
324	the manner in which each local government, regional planning
325	council, and local health council will coordinate its activities
326	to ensure a unified approach to health planning and
327	implementation efforts.
328	(e)  Local health councils may employ personnel or contract
329	for staffing services with persons who possess appropriate
330	qualifications to carry out the councils' purposes.  However,
331	such personnel are not state employees.
332	(f)  Personnel of the local health councils shall provide
333	an annual orientation to council members about council member
334	responsibilities. The orientation shall include presentations
335	and participation by agency staff.
336	(g)  Each local health council is authorized to accept and
337	receive, in furtherance of its health planning functions, funds,
338	grants, and services from governmental agencies and from private
339	or civic sources and to perform studies related to local health
340	planning in exchange for such funds, grants, or services. Each
341	local health council shall, no later than January 30 of each
342	year, render an accounting of the receipt and disbursement of
343	such funds received by it to the Department of Health agency.
344	The department agency shall consolidate all such reports and
345	submit such consolidated report to the Legislature no later than
346	March 1 of each year. Funds received by a local health council
347	pursuant to this paragraph shall not be deemed to be a
348	substitute for, or an offset against, any funding provided
349	pursuant to subsection (2).
350	(2)  FUNDING.--
351	(a)  The Legislature intends that the cost of local health
352	councils be borne by application fees for certificates of need
353	and by assessments on selected health care facilities subject to
354	facility licensure by the Agency for Health Care Administration,
355	including abortion clinics, assisted living facilities,
356	ambulatory surgical centers, birthing centers, clinical
357	laboratories except community nonprofit blood banks and clinical
358	laboratories operated by practitioners for exclusive use
359	regulated under s. 483.035, home health agencies, hospices,
360	hospitals, intermediate care facilities for the developmentally
361	disabled, nursing homes, health care clinics, and multiphasic
362	testing centers and by assessments on organizations subject to
363	certification by the agency pursuant to chapter 641, part III,
364	including health maintenance organizations and prepaid health
365	clinics.
366	(b)1.  A hospital licensed under chapter 395, a nursing
367	home licensed under chapter 400, and an assisted living facility
368	licensed under chapter 400 shall be assessed an annual fee based
369	on number of beds.
370	2.  All other facilities and organizations listed in
371	paragraph (a) shall each be assessed an annual fee of $150.
372	3.  Facilities operated by the Department of Children and
373	Family Services, the Department of Health, or the Department of
374	Corrections and any hospital which meets the definition of rural
375	hospital pursuant to s. 395.602 are exempt from the assessment
376	required in this subsection.
377	(c)1.  The agency shall, by rule, establish fees for
378	hospitals and nursing homes based on an assessment of $2 per
379	bed. However, no such facility shall be assessed more than a
380	total of $500 under this subsection.
381	2.  The agency shall, by rule, establish fees for assisted
382	living facilities based on an assessment of $1 per bed. However,
383	no such facility shall be assessed more than a total of $150
384	under this subsection.
385	3.  The agency shall, by rule, establish an annual fee of
386	$150 for all other facilities and organizations listed in
387	paragraph (a).
388	(d)  The agency shall, by rule, establish a facility
389	billing and collection process for the billing and collection of
390	the health facility fees authorized by this subsection.
391	(e)  A health facility which is assessed a fee under this
392	subsection is subject to a fine of $100 per day for each day in
393	which the facility is late in submitting its annual fee up to
394	maximum of the annual fee owed by the facility.  A facility
395	which refuses to pay the fee or fine is subject to the
396	forfeiture of its license.
397	(f)  The agency shall deposit in the Health Care Trust Fund
398	all health care facility assessments that are assessed under
399	this subsection and proceeds from the certificate-of-need
400	application fees. The agency shall transfer such funds to the
401	Department of Health for an amount sufficient to maintain the
402	aggregate funding of level for the local health councils as
403	specified in the General Appropriations Act. The remaining
404	certificate-of-need application fees shall be used only for the
405	purpose of administering the certificate-of-need program Health
406	Facility and Services Development Act.
407	(3)  DUTIES AND RESPONSIBILITIES OF THE AGENCY.--
408	(a)  The agency, in conjunction with the local health
409	councils, is responsible for the coordinated planning of health
410	care services in the state.
411	(b)  The agency shall develop and maintain a comprehensive
412	health care database for the purpose of health planning and for
413	certificate-of-need determinations.  The agency or its
414	contractor is authorized to require the submission of
415	information from health facilities, health service providers,
416	and licensed health professionals which is determined by the
417	agency, through rule, to be necessary for meeting the agency's
418	responsibilities as established in this section.
419	(c)  The agency shall assist personnel of the local health
420	councils in providing an annual orientation to council members
421	about council member responsibilities.
422	(c)(d)  The Department of Health agency shall contract with
423	the local health councils for the services specified in
424	subsection (1). All contract funds shall be distributed
425	according to an allocation plan developed by the department
426	agency that provides for a minimum and equal funding base for
427	each local health council.  Any remaining funds shall be
428	distributed based on adjustments for workload.  The agency may
429	also make grants to or reimburse local health councils from
430	federal funds provided to the state for activities related to
431	those functions set forth in this section. The department agency
432	may withhold funds from a local health council or cancel its
433	contract with a local health council which does not meet
434	performance standards agreed upon by the department agency and
435	local health councils.
436	Section 4.  Subsections (1), (2), and (5) of section
437	408.034, Florida Statutes, are amended to read:
438	408.034  Duties and responsibilities of agency; rules.--
439	(1)  The agency is designated as the single state agency to
440	issue, revoke, or deny certificates of need and to issue,
441	revoke, or deny exemptions from certificate-of-need review in
442	accordance with the district plans and present and future
443	federal and state statutes.  The agency is designated as the
444	state health planning agency for purposes of federal law.
445	(2)  In the exercise of its authority to issue licenses to
446	health care facilities and health service providers, as provided
447	under chapters 393, 395, and parts II and VI of chapter 400, the
448	agency may not issue a license to any health care facility or,
449	health service provider that, hospice, or part of a health care
450	facility which fails to receive a certificate of need or an
451	exemption for the licensed facility or service.
452	(5)  The agency shall establish by rule a nursing-home-bed-
453	need methodology that has a goal of maintaining a subdistrict
454	average occupancy rate of 94 percent and that reduces the
455	community nursing home bed need for the areas of the state where
456	the agency establishes pilot community diversion programs
457	through the Title XIX aging waiver program.
458	Section 5.  Section 408.035, Florida Statutes, is amended
459	to read:
460	408.035  Review criteria.--The agency shall determine the
461	reviewability of applications and shall review applications for
462	certificate-of-need determinations for health care facilities
463	and health services in context with the following criteria:
464	(1)  The need for the health care facilities and health
465	services being proposed in relation to the applicable district
466	health plan.
467	(2)  The availability, quality of care, accessibility, and
468	extent of utilization of existing health care facilities and
469	health services in the service district of the applicant.
470	(3)  The ability of the applicant to provide quality of
471	care and the applicant's record of providing quality of care.
472	(4)  The need in the service district of the applicant for
473	special health care services that are not reasonably and
474	economically accessible in adjoining areas.
475	(5)  The needs of research and educational facilities,
476	including, but not limited to, facilities with institutional
477	training programs and community training programs for health
478	care practitioners and for doctors of osteopathic medicine and
479	medicine at the student, internship, and residency training
480	levels.
481	(4)(6)  The availability of resources, including health
482	personnel, management personnel, and funds for capital and
483	operating expenditures, for project accomplishment and
484	operation.
485	(5)(7)  The extent to which the proposed services will
486	enhance access to health care for residents of the service
487	district.
488	(6)(8)  The immediate and long-term financial feasibility
489	of the proposal.
490	(7)(9)  The extent to which the proposal will foster
491	competition that promotes quality and cost-effectiveness.
492	(8)(10)  The costs and methods of the proposed
493	construction, including the costs and methods of energy
494	provision and the availability of alternative, less costly, or
495	more effective methods of construction.
496	(9)(11)  The applicant's past and proposed provision of
497	health care services to Medicaid patients and the medically
498	indigent.
499	(10)(12)  The applicant's designation as a Gold Seal
500	Program nursing facility pursuant to s. 400.235, when the
501	applicant is requesting additional nursing home beds at that
502	facility.
503	Section 6.  Section 408.036, Florida Statutes, is amended
504	to read:
505	408.036  Projects subject to review; exemptions.--
506	(1)  APPLICABILITY.--Unless exempt under subsection (3),
507	all health-care-related projects, as described in paragraphs
508	(a)-(g) (a)-(h), are subject to review and must file an
509	application for a certificate of need with the agency. The
510	agency is exclusively responsible for determining whether a
511	health-care-related project is subject to review under ss.
512	408.031-408.045.
513	(a)  The addition of beds in community nursing homes or
514	intermediate care facilities for the developmentally disabled by
515	new construction or alteration.
516	(b)  The new construction or establishment of additional
517	health care facilities, including a replacement health care
518	facility when the proposed project site is not located on the
519	same site as or within 1 mile of the existing health care
520	facility, if the number of beds in each licensed bed category
521	will not increase.
522	(c)  The conversion from one type of health care facility
523	to another, including the conversion from a general hospital, a
524	specialty hospital, or a long-term care hospital.
525	(d)  An increase in the total licensed bed capacity of a
526	health care facility.
527	(d)(e)  The establishment of a hospice or hospice inpatient
528	facility, except as provided in s. 408.043.
529	(f)  The establishment of inpatient health services by a
530	health care facility, or a substantial change in such services.
531	(e)(g)  An increase in the number of beds for acute care,
532	nursing home care beds, specialty burn units, neonatal intensive
533	care units, comprehensive rehabilitation, mental health
534	services, or hospital-based distinct part skilled nursing units,
535	or at a long-term care hospital.
536	(f)(h)  The establishment of tertiary health services,
537	including inpatient comprehensive rehabilitation services.
538	(g)  An increase in the number of beds for acute care in a
539	hospital that is located in a low-growth county. A low-growth
540	county is defined as a county that has:
541	1.  A hospital with an occupancy rate for licensed acute
542	care which has been below 60 percent for the previous 5 years;
543	2.  Experienced a growth rate of 4 percent or less for the
544	most recent 3-year period for which data are available, as
545	determined using the population statistics published in the most
546	recent edition of the Florida Statistical Abstract;
547	3.  A population of 400,000 or fewer according to the most
548	recent edition of the Florida Statistical Abstract; and
549	4.  A hospital that has combined gross revenue from
550	Medicaid and charity patients which exceeds $60 million per year
551	for the previous 2 years.
552
553	This paragraph is repealed effective July 1, 2009.
554	(2)  PROJECTS SUBJECT TO EXPEDITED REVIEW.--Unless exempt
555	pursuant to subsection (3), projects subject to an expedited
556	review shall include, but not be limited to:
557	(a)  Research, education, and training programs.
558	(b)  Shared services contracts or projects.
559	(a)(c)  A transfer of a certificate of need, except that
560	when an existing hospital is acquired by a purchaser, all
561	certificates of need issued to the hospital which are not yet
562	operational shall be acquired by the purchaser, without need for
563	a transfer.
564	(b)  Replacement of a nursing home within the same
565	district, if the proposed project site is located within a
566	geographic area that contains at least 65 percent of the
567	facility's current residents and is within a 30-mile radius of
568	the replaced nursing home.
569	(c)  Relocation of a portion of a nursing home's licensed
570	beds to a facility within the same district, if the relocation
571	is within a 30-mile radius of the existing facility and the
572	total number of nursing home beds in the district does not
573	increase.
574	(d)  A 50-percent increase in nursing home beds for a
575	facility incorporated and operating in this state for at least
576	60 years on or before July 1, 1988, which has a licensed nursing
577	home facility located on a campus providing a variety of
578	residential settings and supportive services.  The increased
579	nursing home beds shall be for the exclusive use of the campus
580	residents.  Any application on behalf of an applicant meeting
581	this requirement shall be subject to the base fee of $5,000
582	provided in s. 408.038.
583	(e)  Replacement of a health care facility when the
584	proposed project site is located in the same district and within
585	a 1-mile radius of the replaced health care facility.
586	(f)  The conversion of mental health services beds licensed
587	under chapter 395 or hospital-based distinct part skilled
588	nursing unit beds to general acute care beds; the conversion of
589	mental health services beds between or among the licensed bed
590	categories defined as beds for mental health services; or the
591	conversion of general acute care beds to beds for mental health
592	services.
593	1.  Conversion under this paragraph shall not establish a
594	new licensed bed category at the hospital but shall apply only
595	to categories of beds licensed at that hospital.
596	2.  Beds converted under this paragraph must be licensed
597	and operational for at least 12 months before the hospital may
598	apply for additional conversion affecting beds of the same type.
599
600	The agency shall develop rules to implement the provisions for
601	expedited review, including time schedule, application content
602	which may be reduced from the full requirements of s.
603	408.037(1), and application processing.
604	(3)  EXEMPTIONS.--Upon request, the following projects are
605	subject to exemption from the provisions of subsection (1):
606	(a)  For replacement of a licensed health care facility on
607	the same site, provided that the number of beds in each licensed
608	bed category will not increase.
609	(a)(b)  For hospice services or for swing beds in a rural
610	hospital, as defined in s. 395.602, in a number that does not
611	exceed one-half of its licensed beds.
612	(b)(c)  For the conversion of licensed acute care hospital
613	beds to Medicare and Medicaid certified skilled nursing beds in
614	a rural hospital, as defined in s. 395.602, so long as the
615	conversion of the beds does not involve the construction of new
616	facilities. The total number of skilled nursing beds, including
617	swing beds, may not exceed one-half of the total number of
618	licensed beds in the rural hospital as of July 1, 1993.
619	Certified skilled nursing beds designated under this paragraph,
620	excluding swing beds, shall be included in the community nursing
621	home bed inventory.  A rural hospital that which subsequently
622	decertifies any acute care beds exempted under this paragraph
623	shall notify the agency of the decertification, and the agency
624	shall adjust the community nursing home bed inventory
625	accordingly.
626	(c)(d)  For the addition of nursing home beds at a skilled
627	nursing facility that is part of a retirement community that
628	provides a variety of residential settings and supportive
629	services and that has been incorporated and operated in this
630	state for at least 65 years on or before July 1, 1994. All
631	nursing home beds must not be available to the public but must
632	be for the exclusive use of the community residents.
633	(e)  For an increase in the bed capacity of a nursing
634	facility licensed for at least 50 beds as of January 1, 1994,
635	under part II of chapter 400 which is not part of a continuing
636	care facility if, after the increase, the total licensed bed
637	capacity of that facility is not more than 60 beds and if the
638	facility has been continuously licensed since 1950 and has
639	received a superior rating on each of its two most recent
640	licensure surveys.
641	(d)(f)  For an inmate health care facility built by or for
642	the exclusive use of the Department of Corrections as provided
643	in chapter 945. This exemption expires when such facility is
644	converted to other uses.
645	(g)  For the termination of an inpatient health care
646	service, upon 30 days' written notice to the agency.
647	(h)  For the delicensure of beds, upon 30 days' written
648	notice to the agency. A request for exemption submitted under
649	this paragraph must identify the number, the category of beds,
650	and the name of the facility in which the beds to be delicensed
651	are located.
652	(i)  For the provision of adult inpatient diagnostic
653	cardiac catheterization services in a hospital.
654	1.  In addition to any other documentation otherwise
655	required by the agency, a request for an exemption submitted
656	under this paragraph must comply with the following criteria:
657	a.  The applicant must certify it will not provide
658	therapeutic cardiac catheterization pursuant to the grant of the
659	exemption.
660	b.  The applicant must certify it will meet and
661	continuously maintain the minimum licensure requirements adopted
662	by the agency governing such programs pursuant to subparagraph
663	2.
664	c.  The applicant must certify it will provide a minimum of
665	2 percent of its services to charity and Medicaid patients.
666	2.  The agency shall adopt licensure requirements by rule
667	which govern the operation of adult inpatient diagnostic cardiac
668	catheterization programs established pursuant to the exemption
669	provided in this paragraph. The rules shall ensure that such
670	programs:
671	a.  Perform only adult inpatient diagnostic cardiac
672	catheterization services authorized by the exemption and will
673	not provide therapeutic cardiac catheterization or any other
674	services not authorized by the exemption.
675	b.  Maintain sufficient appropriate equipment and health
676	personnel to ensure quality and safety.
677	c.  Maintain appropriate times of operation and protocols
678	to ensure availability and appropriate referrals in the event of
679	emergencies.
680	d.  Maintain appropriate program volumes to ensure quality
681	and safety.
682	e.  Provide a minimum of 2 percent of its services to
683	charity and Medicaid patients each year.
684	3.a.  The exemption provided by this paragraph shall not
685	apply unless the agency determines that the program is in
686	compliance with the requirements of subparagraph 1. and that the
687	program will, after beginning operation, continuously comply
688	with the rules adopted pursuant to subparagraph 2.  The agency
689	shall monitor such programs to ensure compliance with the
690	requirements of subparagraph 2.
691	b.(I)  The exemption for a program shall expire immediately
692	when the program fails to comply with the rules adopted pursuant
693	to sub-subparagraphs 2.a., b., and c.
694	(II)  Beginning 18 months after a program first begins
695	treating patients, the exemption for a program shall expire when
696	the program fails to comply with the rules adopted pursuant to
697	sub-subparagraphs 2.d. and e.
698	(III)  If the exemption for a program expires pursuant to
699	sub-sub-subparagraph (I) or sub-sub-subparagraph (II), the
700	agency shall not grant an exemption pursuant to this paragraph
701	for an adult inpatient diagnostic cardiac catheterization
702	program located at the same hospital until 2 years following the
703	date of the determination by the agency that the program failed
704	to comply with the rules adopted pursuant to subparagraph 2.
705	(e)(j)  For mobile surgical facilities and related health
706	care services provided under contract with the Department of
707	Corrections or a private correctional facility operating
708	pursuant to chapter 957.
709	(f)(k)  For state veterans' nursing homes operated by or on
710	behalf of the Florida Department of Veterans' Affairs in
711	accordance with part II of chapter 296 for which at least 50
712	percent of the construction cost is federally funded and for
713	which the Federal Government pays a per diem rate not to exceed
714	one-half of the cost of the veterans' care in such state nursing
715	homes. These beds shall not be included in the nursing home bed
716	inventory.
717	(g)(l)  For combination within one nursing home facility of
718	the beds or services authorized by two or more certificates of
719	need issued in the same planning subdistrict.  An exemption
720	granted under this paragraph shall extend the validity period of
721	the certificates of need to be consolidated by the length of the
722	period beginning upon submission of the exemption request and
723	ending with issuance of the exemption.  The longest validity
724	period among the certificates shall be applicable to each of the
725	combined certificates.
726	(h)(m)  For division into two or more nursing home
727	facilities of beds or services authorized by one certificate of
728	need issued in the same planning subdistrict.  An exemption
729	granted under this paragraph shall extend the validity period of
730	the certificate of need to be divided by the length of the
731	period beginning upon submission of the exemption request and
732	ending with issuance of the exemption.
733	(i)(n)  For the addition of hospital beds licensed under
734	chapter 395 for comprehensive rehabilitation acute care, mental
735	health services, or a hospital-based distinct part skilled
736	nursing unit in a number that may not exceed 10 total beds or 10
737	percent of the licensed capacity of the bed category being
738	expanded, whichever is greater. Beds for specialty burn units,
739	neonatal intensive care units, or comprehensive rehabilitation,
740	or at a long-term care hospital, may not be increased under this
741	paragraph.
742	1.  In addition to any other documentation otherwise
743	required by the agency, a request for exemption submitted under
744	this paragraph must:
745	a.  Certify that the prior 12-month average occupancy rate
746	for the category of licensed beds being expanded at the facility
747	meets or exceeds 80 percent or, for a hospital-based distinct
748	part skilled nursing unit, the prior 12-month average occupancy
749	rate meets or exceeds 96 percent.
750	b.  Certify that the any beds of the same type authorized
751	for the facility under this paragraph before the date of the
752	current request for an exemption have been licensed and
753	operational for at least 12 months.
754	2.  The timeframes and monitoring process specified in s.
755	408.040(2)(a)-(c) apply to any exemption issued under this
756	paragraph.
757	3.  The agency shall count beds authorized under this
758	paragraph as approved beds in the published inventory of
759	hospital beds until the beds are licensed.
760	(o)  For the addition of acute care beds, as authorized by
761	rule consistent with s. 395.003(4), in a number that may not
762	exceed 10 total beds or 10 percent of licensed bed capacity,
763	whichever is greater, for temporary beds in a hospital that has
764	experienced high seasonal occupancy within the prior 12-month
765	period or in a hospital that must respond to emergency
766	circumstances.
767	(j)(p)  For the addition of nursing home beds licensed
768	under chapter 400 in a number not exceeding 10 total beds or 10
769	percent of the number of beds licensed in the facility being
770	expanded, whichever is greater; or, for the addition of nursing
771	home beds licensed under chapter 400 at a facility that has been
772	designated as a Gold Seal nursing home under s. 400.235 in a
773	number not exceeding 20 total beds or 10 percent of the number
774	of licensed beds in the facility being expanded, whichever is
775	greater.
776	1.  In addition to any other documentation required by the
777	agency, a request for exemption submitted under this paragraph
778	must:
779	a.  Effective until June 30, 2001, Certify that the
780	facility has not had any class I or class II deficiencies within
781	the 30 months preceding the request for addition.
782	b.  Effective on July 1, 2001, certify that the facility
783	has been designated as a Gold Seal nursing home under s.
784	400.235.
785	b.c.  Certify that the prior 12-month average occupancy
786	rate for the nursing home beds at the facility meets or exceeds
787	96 percent.
788	c.d.  Certify that any beds authorized for the facility
789	under this paragraph before the date of the current request for
790	an exemption have been licensed and operational for at least 12
791	months.
792	2.  The timeframes and monitoring process specified in s.
793	408.040(2)(a)-(c) apply to any exemption issued under this
794	paragraph.
795	3.  The agency shall count beds authorized under this
796	paragraph as approved beds in the published inventory of nursing
797	home beds until the beds are licensed.
798	(k)  For the establishment of:
799	1.  A Level II neonatal intensive care unit with at least
800	10 beds, upon documentation to the agency that the applicant
801	hospital had a minimum of 1,500 births during the previous 12
802	months; or
803	2.  A Level III neonatal intensive care unit with at least
804	15 beds, upon documentation to the agency that the applicant
805	hospital has a Level II neonatal intensive care unit of at least
806	10 beds and had a minimum of 3,500 births during the previous 12
807	months,
808
809	if the applicant demonstrates that it meets the requirements for
810	quality of care, nurse staffing, physician staffing, physical
811	plant, equipment, emergency transportation, and data reporting
812	found in agency certificate-of-need rules for Level II and Level
813	III neonatal intensive care units and if the applicant commits
814	to the provision of services to Medicaid and charity patients at
815	a level equal to or greater than the district average. Such a
816	commitment is subject to s. 408.040.
817	(q)  For establishment of a specialty hospital offering a
818	range of medical service restricted to a defined age or gender
819	group of the population or a restricted range of services
820	appropriate to the diagnosis, care, and treatment of patients
821	with specific categories of medical illnesses or disorders,
822	through the transfer of beds and services from an existing
823	hospital in the same county.
824	(r)  For the conversion of hospital-based Medicare and
825	Medicaid certified skilled nursing beds to acute care beds, if
826	the conversion does not involve the construction of new
827	facilities.
828	(l)  Notwithstanding any other provisions of this chapter
829	to the contrary:(s)
830	1.  For an adult open-heart-surgery program to be located
831	in a new hospital provided the new hospital is being established
832	in the location of an existing hospital with an adult open-
833	heart-surgery program, the existing hospital and the existing
834	adult open-heart-surgery program are being relocated to a
835	replacement hospital, and the replacement hospital will utilize
836	a closed-staff model. A hospital is exempt from the certificate-
837	of-need review for the establishment of an open-heart-surgery
838	program if the application for exemption submitted under this
839	paragraph complies with the following criteria:
840	a.  The applicant must certify that it will meet and
841	continuously maintain the minimum Florida Administrative Code
842	and any future licensure requirements governing adult open-heart
843	programs adopted by the agency, including the most current
844	guidelines of the American College of Cardiology and American
845	Heart Association Guidelines for Adult Open Heart Programs.
846	b.  The applicant must certify that it will maintain
847	sufficient appropriate equipment and health personnel to ensure
848	quality and safety.
849	c.  The applicant must certify that it will maintain
850	appropriate times of operation and protocols to ensure
851	availability and appropriate referrals in the event of
852	emergencies.
853	d.  The applicant is a newly licensed hospital in a
854	physical location previously owned and licensed to a hospital
855	performing more than 300 open-heart procedures each year,
856	including heart transplants.
857	e.  The applicant must certify that it can perform more
858	than 300 diagnostic cardiac catheterization procedures per year,
859	combined inpatient and outpatient, by the end of the third year
860	of its operation.
861	f.  The applicant's payor mix at a minimum reflects the
862	community average for Medicaid, charity care, and self-pay
863	patients or the applicant must certify that it will provide a
864	minimum of 5 percent of Medicaid, charity care, and self-pay to
865	open-heart-surgery patients.
866	g.  If the applicant fails to meet the established criteria
867	for open-heart programs or fails to reach 300 surgeries per year
868	by the end of its third year of operation, it must show cause
869	why its exemption should not be revoked.
870	h.  In order to ensure continuity of available services,
871	the applicant of the newly licensed hospital may apply for this
872	certificate-of-need before taking possession of the physical
873	facilities. The effective date of the certificate-of-need will
874	be concurrent with the effective date of the newly issued
875	hospital license.
876	2.  By December 31, 2004, and annually thereafter, the
877	agency shall submit a report to the Legislature providing
878	information concerning the number of requests for exemption
879	received under this paragraph and the number of exemptions
880	granted or denied.
881	3.  This paragraph is repealed effective January 1, 2008.
882	(m)(t)1.  For the provision of adult open-heart services in
883	a hospital located within the boundaries of a health service
884	planning district, as defined in s. 408.032(5), which has
885	experienced an annual net out-migration of at least 600 open-
886	heart-surgery cases for 3 consecutive years according to the
887	most recent data reported to the agency, and the district's
888	population per licensed and operational open-heart programs
889	exceeds the state average of population per licensed and
890	operational open-heart programs by at least 25 percent Palm
891	Beach, Polk, Martin, St. Lucie, and Indian River Counties if the
892	following conditions are met: The exemption must be based upon
893	objective criteria and address and solve the twin problems of
894	geographic and temporal access. All hospitals within a health
895	service planning district which meet the criteria reference in
896	sub-subparagraphs 2.a.-h. shall be eligible for this exemption
897	on July 1, 2004, and shall receive the exemption upon filing for
898	it and subject to the following:
899	a.  A hospital that has received a notice of intent to
900	grant a certificate of need or a final order of the agency
901	granting a certificate of need for the establishment of an open-
902	heart-surgery program is entitled to receive a letter of
903	exemption for the establishment of an adult open-heart-surgery
904	program upon filing a request for exemption and complying with
905	the criteria enumerated in sub-subparagraphs 2.a.-h., and is
906	entitled to immediately commence operation of the program.
907	b.  An otherwise eligible hospital that has not received a
908	notice of intent to grant a certificate of need or a final order
909	of the agency granting a certificate of need for the
910	establishment of an open-heart-surgery program is entitled to
911	immediately receive a letter of exemption for the establishment
912	of an adult open-heart-surgery program upon filing a request for
913	exemption and complying with the criteria enumerated in sub-
914	subparagraphs 2.a.-h., but is not entitled to commence operation
915	of its program until December 31, 2006.
916	2.  A hospital shall be exempt from the certificate-of-need
917	review for the establishment of an open-heart-surgery program
918	when the application for exemption submitted under this
919	paragraph complies with the following criteria:
920	a.  The applicant must certify that it will meet and
921	continuously maintain the minimum licensure requirements adopted
922	by the agency governing adult open-heart programs, including the
923	most current guidelines of the American College of Cardiology
924	and American Heart Association Guidelines for Adult Open Heart
925	Programs.
926	b.  The applicant must certify that it will maintain
927	sufficient appropriate equipment and health personnel to ensure
928	quality and safety.
929	c.  The applicant must certify that it will maintain
930	appropriate times of operation and protocols to ensure
931	availability and appropriate referrals in the event of
932	emergencies.
933	d.  The applicant can demonstrate that it has discharged at
934	least 300 inpatients with a principal diagnosis of ischemic
935	heart disease for the most recent 12-month period as reported to
936	the agency is referring 300 or more patients per year from the
937	hospital, including the emergency room, for cardiac services at
938	a hospital with cardiac services, or that the average wait for
939	transfer for 50 percent or more of the cardiac patients exceeds
940	4 hours.
941	e.  The applicant is a general acute care hospital that is
942	in operation for 3 years or more.
943	f.  The applicant is performing more than 300 diagnostic
944	cardiac catheterization procedures per year, combined inpatient
945	and outpatient.
946	g.  The applicant's payor mix at a minimum reflects the
947	community average for Medicaid, charity care, and self-pay
948	patients or the applicant must certify that it will provide a
949	minimum of 5 percent of Medicaid, charity care, and self-pay to
950	open-heart-surgery patients.
951	h.  If the applicant fails to meet the established criteria
952	for open-heart programs or fails to reach 300 surgeries per year
953	by the end of its third year of operation, it must show cause
954	why its exemption should not be revoked.
955	3.2.  By December 31, 2004, and annually thereafter, the
956	agency for Health Care Administration shall submit a report to
957	the Legislature providing information concerning the number of
958	requests for exemption it has received under this paragraph
959	during the calendar year and the number of exemptions it has
960	granted or denied during the calendar year.
961	(n)  For the provision of percutaneous coronary
962	intervention for patients presenting with emergency myocardial
963	infarctions in a hospital without an approved adult open-heart-
964	surgery program. In addition to any other documentation required
965	by the agency, a request for an exemption submitted under this
966	paragraph must comply with the following:
967	1.  The applicant must certify that it will meet and
968	continuously maintain the requirements adopted by the agency for
969	the provisions of these services. These licensure requirements
970	must be adopted by rule pursuant to ss. 120.536(1) and 120.54
971	and must be consistent with the guidelines published by the
972	American College of Cardiology and the American Heart
973	Association for the provision of percutaneous coronary
974	interventions in hospitals without adult open-heart services. At
975	a minimum, the rules shall require that:
976	a.  Cardiologists be experienced interventionalists who
977	have performed a mimimum of 75 interventions within the previous
978	12 months.
979	b.  The hospital provide a minimum of 36 emergency
980	interventions annually in order to continue to provide the
981	service.
982	c.  The hospital offer sufficient physician, nursing, and
983	laboratory staff to provide the services 24 hours a day, 7 days
984	a week.
985	d.  Nursing and technical staff have demonstrated
986	experience in handling acutely ill patients requiring
987	intervention based on previous experience in dedicated
988	interventional laboratories or surgical centers.
989	e.  Cardiac care nursing staff be adept in hemodynamic
990	monitoring and Intra-aortic Balloon Pump management.
991	f.  Formalized written transfer agreements be developed
992	with a hospital with an adult open-heart-surgery program and
993	written transport protocols be in place to ensure safe and
994	efficient transfer of a patient within 60 minutes. Transfer and
995	transport agreements must be received and tested, with
996	appropriate documentation maintained at least every 3 months.
997	g.  Hospitals implementing the service first undertake a
998	training program of 3 to 6 months' duration, which includes
999	establishing standard and testing logistics, creating quality
1000	assessment and error management practices, and formalizing
1001	patient-selection criteria.
1002	2.  The applicant must certify that it will at all times
1003	use the patient-selection criteria for the performance of
1004	primary angioplasty at hospitals without adult open-heart-
1005	surgery programs issued by the American College of Cardiology
1006	and the American Heart Association. At a minimum, these criteria
1007	must provide for:
1008	a.  Avoidance of interventions in hemodynamically stable
1009	patients who have identified symptoms or medical histories.
1010	b.  Transfer of patients who have a history of coronary
1011	disease and clinical presentation of hemodynamic instability.
1012	3.  The applicant must agree to submit to the agency a
1013	quarterly report detailing patient characteristics, treatment,
1014	and outcomes for all patients receiving emergency percutaneous
1015	coronary interventions pursuant to this paragraph. This report
1016	must be submitted within 15 days after the close of each
1017	calendar quarter.
1018	4.  The exemption provided by this paragraph does not apply
1019	unless the agency determines that the hospital has taken all
1020	necessary steps to be in compliance with all requirements of
1021	this paragraph, including the training program required under
1022	sub-subparagraph 1.g.
1023	5.  If the hospital fails to continuously comply with the
1024	requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2.
1025	and 3., this exemption immediately expires.
1026	6.  If the hospital fails to meet the volume requirements
1027	of sub-subparagraphs 1.a. and b. within 18 months after the
1028	program begins offering the service, this exemption immediately
1029	expires.
1030
1031	If the exemption for this service expires under subparagraph 5.
1032	or subparagraph 6., the agency may not grant another exemption
1033	for this service to the same hospital for 2 years and then only
1034	upon a showing that the hospital will remain in compliance with
1035	the requirements of this paragraph through a demonstration of
1036	corrections to the deficiencies that caused the exemption to
1037	expire. Compliance with this paragraph includes compliance with
1038	the rules adopted pursuant to this paragraph.
1039	(o)  For the addition of mental health services or beds if
1040	the applicant commits to providing services to Medicaid or
1041	charity care patients at a level equal to or greater than the
1042	district average. Such a commitment is subject to s. 408.040.
1043	(p)  For replacement of a licensed nursing home on the same
1044	site, or within 3 miles of the same site, if the number of
1045	licensed beds does not increase.
1046	(q)  For consolidation or combination of licensed nursing
1047	homes or transfer of beds between licensed nursing homes within
1048	the same planning subdistrict, by providers that operate
1049	multiple nursing homes within that planning subdistrict, if
1050	there is no increase in the planning subdistrict total number of
1051	nursing home beds and the site of the relocation is not more
1052	than 30 miles from the original location.
1053	(r)  For beds in state mental health treatment facilities
1054	operated under s. 394.455(30) and state mental health forensic
1055	facilities operated under s. 916.106(8).
1056	(s)  For beds in state developmental services institutions
1057	as defined in s. 393.063.
1058	(4)  REQUESTS FOR EXEMPTION.--A request for exemption under
1059	subsection (3) may be made at any time and is not subject to the
1060	batching requirements of this section. The request shall be
1061	supported by such documentation as the agency requires by rule.
1062	The agency shall assess a fee of $250 for each request for
1063	exemption submitted under subsection (3).
1064	(5)  NOTIFICATION.--Health care facilities and providers
1065	must provide to the agency notification of:
1066	(a)  Replacement of a health care facility when the
1067	proposed project site is located in the same district and on the
1068	existing site or within a 1-mile radius of the replaced health
1069	care facility, if the number and type of beds do not increase.
1070	(b)  The termination of a health care service, upon 30
1071	days' written notice to the agency.
1072	(c)  The addition or delicensure of beds.
1073
1074	Notification under this subsection may be made by electronic,
1075	facsimile, or written means at any time before the described
1076	action has been taken.
1077	Section 7.  Section 408.0361, Florida Statutes, is amended
1078	to read:
1079	408.0361  Cardiology services and burn unit licensure
1080	Diagnostic cardiac catheterization services providers;
1081	compliance with guidelines and requirements.--
1082	(1)  Each provider of diagnostic cardiac catheterization
1083	services shall comply with the requirements of s.
1084	408.036(3)(i)2.a.-d., and rules adopted by of the agency which
1085	establish licensure standards for Health Care Administration
1086	governing the operation of adult inpatient diagnostic cardiac
1087	catheterization programs. The rules must ensure that the
1088	programs:
1089	(a)  Comply with, including the most recent guidelines of
1090	the American College of Cardiology and American Heart
1091	Association Guidelines for Cardiac Catheterization and Cardiac
1092	Catheterization Laboratories.
1093	(b)  Perform only adult inpatient diagnostic cardiac
1094	catheterization services and do not provide therapeutic cardiac
1095	catheterization or any other cardiology services.
1096	(c)  Maintain sufficient appropriate equipment and health
1097	care personnel to ensure quality and safety.
1098	(d)  Maintain appropriate times of operation and protocols
1099	to ensure availability and appropriate referrals in the event of
1100	emergencies.
1101	(e)  Demonstrate a plan to provide services to Medicaid and
1102	charity patients.
1103	(2)  Each provider of adult interventional cardiology
1104	services or operator of a burn unit shall comply with rules
1105	adopted by the agency which establish licensure standards that
1106	govern the provision of adult interventional cardiology services
1107	or the operation of a burn unit. Such rules must consider, at a
1108	minimum, staffing, equipment, physical plant, operating
1109	protocols, the provision of services to Medicaid and charity
1110	patients, accreditation, licensure period and fees, and
1111	enforcement of minimum standards. The certificate-of-need rules
1112	for adult interventional cardiology services and burn units in
1113	effect on June 30, 2004, are ratified pursuant to this
1114	subsection and shall remain in effect and be enforceable by the
1115	agency until the licensure rules are adopted. Existing
1116	providers, any provider with an exemption for open heart
1117	surgery, and any provider with a notice of intent to grant a
1118	certificate of need or a final order of the agency granting a
1119	certificate of need for adult interventional cardiology services
1120	or burn units shall be considered grandfathered-in and shall
1121	receive a license for their programs effective on July 1, 2004,
1122	or the date their program becomes operational, whichever is
1123	later. That licensure shall remain valid for at least 3 years or
1124	a period specified in the rule, whichever is longer, but the
1125	programs must meet licensure standards applicable to existing
1126	programs for every subsequent licensure period.
1127	(3)  In establishing rules for adult interventional
1128	cardiology services, the agency shall include provisions that
1129	allow for:
1130	(a)  Establishment of two hospital program licensure
1131	levels: a Level I program authorizing the performance of adult
1132	primary percutaneous cardiac intervention for emergent patients
1133	without onsite cardiac surgery and a Level II program
1134	authorizing the performance of percutaneous cardiac intervention
1135	with onsite cardiac surgery.
1136	(b)  For a hospital seeking a Level I program,
1137	demonstration that, for the most recent 12-month period as
1138	reported to the agency, it has provided a minimum of 300 adult
1139	inpatient and outpatient diagnostic cardiac catheterizations or
1140	has transferred at least 300 inpatients with the principal
1141	diagnosis of ischemic heart disease and that it has a
1142	formalized, written transfer agreement with a hospital that has
1143	a Level II program, including written transport protocols to
1144	ensure safe and efficient transfer of a patient within 60
1145	minutes.
1146	(c)  For a hospital seeking a Level II program,
1147	demonstration that for the most recent 12-month period as
1148	reported to the agency it has discharged at least 800 patients
1149	with the principal diagnosis of ischemic heart disease.
1150	(d)  Compliance with the most recent guidelines of the
1151	American College of Cardiology and American Heart Association
1152	guidelines for staffing, physician training and experience,
1153	operating procedures, equipment, physical plant, and patient-
1154	selection criteria to ensure patient quality and safety.
1155	(e)  Establishment of appropriate hours of operation and
1156	protocols to ensure availability and timely referral in the
1157	event of emergencies.
1158	(f)  Demonstration of a plan to provide services to
1159	Medicaid and charity patients.
1160	(4)  The agency shall establish a technical advisory panel
1161	to develop procedures and standards for measuring outcomes of
1162	interventional cardiac programs. Members of the panel shall
1163	include representatives of the Florida Hospital Association, the
1164	Florida Society of Thoracic and Cardiovascular Surgeons, the
1165	Florida Chapter of the American College of Cardiology, and the
1166	Florida Chapter of the American Heart Association and others who
1167	have experience in statistics and outcome measurement. Based
1168	upon recommendations from the panel, the agency shall develop
1169	and adopt for the interventional cardiac programs rules that
1170	include at least the following:
1171	(a)  A standard data set consisting primarily of data
1172	elements reported to the agency in accordance with s. 408.061.
1173	(b)  A risk-adjustment procedure that accounts for the
1174	variations in severity and case mix found in hospitals in this
1175	state.
1176	(c)  Outcome standards specifying expected levels of
1177	performance in Level I and Level II adult interventional
1178	cardiology services. Such standards may include, but are not
1179	limited to, inhospital mortality, infection rates, nonfatal
1180	myocardial infarctions, length of stay, postoperative bleeds,
1181	and returns to surgery.
1182	(d)  Specific steps to be taken by the agency and licensing
1183	hospitals that do not meet the outcome standards within
1184	specified time periods, including time periods for detailed case
1185	reviews and development and implementation of corrective action
1186	plans.
1187	(9)  The Secretary of Health Care Administration shall
1188	appoint an advisory group to study the issue of replacing
1189	certificate-of-need review of organ transplant programs under
1190	this chapter with licensure regulation of organ transplant
1191	programs under chapter 395. The advisory group shall include
1192	three representatives of organ transplant providers, one
1193	representative of an organ procurement organization, one
1194	representative of the Division of Health Quality Assurance, one
1195	representative of Medicaid, and one advocate for organ
1196	transplant patients. The advisory group shall, at a minimum,
1197	make recommendations regarding access to organs, delivery of
1198	services to Medicaid and charity patients, staff training, and
1199	resource requirements for organ transplant programs in a report
1200	due to the secretary and the Legislature by July 1, 2005.
1201	(10)  The Secretary of Health Care Administration shall
1202	appoint a work group to study certificate-of-need regulations
1203	and changing market conditions related to the supply and
1204	distribution of hospital beds. The assessment by the work group
1205	shall include, but need not be limited to:
1206	(a)  The appropriateness of current certificate-of-need
1207	methodologies and other criteria for evaluating proposals for
1208	new hospitals and transfers of beds to new sites.
1209	(b)  Additional factors that should be considered,
1210	including the viability of safety-net services, the extent of
1211	market competition, and the accessibility of hospital services.
1212
1213	The workgroup shall, by January 1, 2005, submit to the secretary
1214	and the Legislature a report identifying specific program areas
1215	and recommending needed changes in statutes and rules.
1216	Section 8.  Section 408.038, Florida Statutes, is amended
1217	to read:
1218	408.038  Fees.--The agency shall assess fees on
1219	certificate-of-need applications.  Such fees shall be for the
1220	purpose of funding the functions of the local health councils
1221	and the activities of the agency and shall be allocated as
1222	provided in s. 408.033. The fee shall be determined as follows:
1223	(1)  A minimum base fee of $10,000 $5,000.
1224	(2)  In addition to the base fee of $10,000 $5,000, 0.015
1225	of each dollar of proposed expenditure, except that a fee may
1226	not exceed $50,000 $22,000.
1227	Section 9.  Subsections (1), paragraph (a) of subsection
1228	(3), and paragraph (a) and (b) of subsection (4) of section
1229	408.039, are amended to read:
1230	408.039  Review process.--The review process for
1231	certificates of need shall be as follows:
1232	(1)  REVIEW CYCLES.--The agency by rule shall provide for
1233	applications to be submitted on a timetable or cycle basis;
1234	provide for review on a timely basis; and provide for all
1235	completed applications pertaining to similar types of services
1236	or facilities affecting the same service district to be
1237	considered in relation to each other no less often than annually
1238	two times a year.
1239	(3)  APPLICATION PROCESSING.--
1240	(a)  An applicant shall file an application with the
1241	agency, and shall furnish a copy of the application to the local
1242	health council and the agency. Within 15 days after the
1243	applicable application filing deadline established by agency
1244	rule, the staff of the agency shall determine if the application
1245	is complete.  If the application is incomplete, the staff shall
1246	request specific information from the applicant necessary for
1247	the application to be complete; however, the staff may make only
1248	one such request. If the requested information is not filed with
1249	the agency within 21 days after of the receipt of the staff's
1250	request, the application shall be deemed incomplete and deemed
1251	withdrawn from consideration.
1252	(4)  STAFF RECOMMENDATIONS.--
1253	(a)  The agency's review of and final agency action on
1254	applications shall be in accordance with the district health
1255	plan, and statutory criteria, and the implementing
1256	administrative rules.  In the application review process, the
1257	agency shall give a preference, as defined by rule of the
1258	agency, to an applicant which proposes to develop a nursing home
1259	in a nursing home geographically underserved area.
1260	(b)  Within 60 days after all the applications in a review
1261	cycle are determined to be complete, the agency shall issue its
1262	State Agency Action Report and Notice of Intent to grant a
1263	certificate of need for the project in its entirety, to grant a
1264	certificate of need for identifiable portions of the project, or
1265	to deny a certificate of need.  The State Agency Action Report
1266	shall set forth in writing its findings of fact and
1267	determinations upon which its decision is based.  If a finding
1268	of fact or determination by the agency is counter to the
1269	district health plan of the local health council, the agency
1270	shall provide in writing its reason for its findings, item by
1271	item, to the local health council.  If the agency intends to
1272	grant a certificate of need, the State Agency Action Report or
1273	the Notice of Intent shall also include any conditions which the
1274	agency intends to attach to the certificate of need. The agency
1275	shall designate by rule a senior staff person, other than the
1276	person who issues the final order, to issue State Agency Action
1277	Reports and Notices of Intent.
1278	Section 10.  Section 408.040, Florida Statutes, is amended
1279	to read:
1280	408.040  Conditions and monitoring.--
1281	(1)(a)  The agency may issue a certificate of need, or an
1282	exemption, predicated upon statements of intent expressed by an
1283	applicant in the application for a certificate of need or an
1284	exemption. Any conditions imposed on a certificate of need or an
1285	exemption based on such statements of intent shall be stated on
1286	the face of the certificate of need or in the exemption
1287	approval.
1288	(b)  The agency may consider, in addition to the other
1289	criteria specified in s. 408.035, a statement of intent by the
1290	applicant that a specified percentage of the annual patient days
1291	at the facility will be utilized by patients eligible for care
1292	under Title XIX of the Social Security Act. Any certificate of
1293	need issued to a nursing home in reliance upon an applicant's
1294	statements that a specified percentage of annual patient days
1295	will be utilized by residents eligible for care under Title XIX
1296	of the Social Security Act must include a statement that such
1297	certification is a condition of issuance of the certificate of
1298	need. The certificate-of-need program shall notify the Medicaid
1299	program office and the Department of Elderly Affairs when it
1300	imposes conditions as authorized in this paragraph in an area in
1301	which a community diversion pilot project is implemented.
1302	(c)  A certificateholder or an exemption holder may apply
1303	to the agency for a modification of conditions imposed under
1304	paragraph (a) or paragraph (b). If the holder of a certificate
1305	of need or an exemption demonstrates good cause why the
1306	certificate or exemption should be modified, the agency shall
1307	reissue the certificate of need or exemption with such
1308	modifications as may be appropriate.  The agency shall by rule
1309	define the factors constituting good cause for modification.
1310	(d)  If the holder of a certificate of need or an exemption
1311	fails to comply with a condition upon which the issuance of the
1312	certificate or exemption was predicated, the agency may assess
1313	an administrative fine against the certificateholder or
1314	exemption holder in an amount not to exceed $1,000 per failure
1315	per day. Failure to annually report compliance with any
1316	condition upon which the issuance of the certificate or
1317	exemption was predicated constitutes noncompliance. In assessing
1318	the penalty, the agency shall take into account as mitigation
1319	the degree of noncompliance relative lack of severity of a
1320	particular failure.  Proceeds of such penalties shall be
1321	deposited in the Public Medical Assistance Trust Fund.
1322	(2)(a)  Unless the applicant has commenced construction, if
1323	the project provides for construction, unless the applicant has
1324	incurred an enforceable capital expenditure commitment for a
1325	project, if the project does not provide for construction, or
1326	unless subject to paragraph (b), a certificate of need shall
1327	terminate 18 months after the date of issuance. The agency shall
1328	monitor the progress of the holder of the certificate of need in
1329	meeting the timetable for project development specified in the
1330	application with the assistance of the local health council as
1331	specified in s. 408.033(1)(b)5., and may revoke the certificate
1332	of need, if the holder of the certificate is not meeting such
1333	timetable and is not making a good-faith effort, as defined by
1334	rule, to meet it.
1335	(b)  A certificate of need issued to an applicant holding a
1336	provisional certificate of authority under chapter 651 shall
1337	terminate 1 year after the applicant receives a valid
1338	certificate of authority from the Office of Insurance Regulation
1339	of the Financial Services Commission.
1340	(c)  The certificate-of-need validity period for a project
1341	shall be extended by the agency, to the extent that the
1342	applicant demonstrates to the satisfaction of the agency that
1343	good-faith commencement of the project is being delayed by
1344	litigation or by governmental action or inaction with respect to
1345	regulations or permitting precluding commencement of the
1346	project.
1347	(3)  The agency shall require the submission of an executed
1348	architect's certification of final payment for each certificate-
1349	of-need project approved by the agency.  Each project that
1350	involves construction shall submit such certification to the
1351	agency within 30 days following completion of construction.
1352	Section 11.  Subsection (5) of section 408.043, Florida
1353	Statutes, is repealed.
1354	Section 12.  Section 408.0455, Florida Statutes, is amended
1355	to read:
1356	408.0455  Rules; pending proceedings.--The rules of the
1357	agency in effect on June 30, 2004 1997, shall remain in effect
1358	and shall be enforceable by the agency with respect to ss.
1359	408.031-408.045 until such rules are repealed or amended by the
1360	agency, and no judicial or administrative proceeding pending on
1361	July 1, 1997, shall be abated as a result of the provisions of
1362	ss. 408.031-408.043(1) and (2); s. 408.044; or s. 408.045.
1363	Section 13.  If any provision of this act or the
1364	application thereof to any person or circumstance is held
1365	invalid, the invalidity does not affect other provisions or
1366	applications of the act which can be given effect without the
1367	invalid provision or application, and to this end the provisions
1368	of this act are declared severable.
1369	Section 14.  Section 52 of chapter 2001-45, Laws of
1370	Florida, as amended by section 1693 of chapter 2003-261, Laws of
1371	Florida, is amended to read:
1372	Section 52.  (1)  Notwithstanding the establishment of need
1373	as provided for in chapter 408, Florida Statutes, no certificate
1374	of need for additional community nursing home beds shall be
1375	approved by the agency until July 1, 2006.
1376	(2)  The Legislature finds that the continued growth in the
1377	Medicaid budget for nursing home care has constrained the
1378	ability of the state to meet the needs of its elderly residents
1379	through the use of less restrictive and less institutional
1380	methods of long-term care. It is therefore the intent of the
1381	Legislature to limit the increase in Medicaid nursing home
1382	expenditures in order to provide funds to invest in long-term
1383	care that is community-based and provides supportive services in
1384	a manner that is both more cost-effective and more in keeping
1385	with the wishes of the elderly residents of this state.
1386	(3)  This moratorium on certificates of need shall not
1387	apply to sheltered nursing home beds in a continuing care
1388	retirement community certified by the former Department of
1389	Insurance or by the Office of Insurance Regulation pursuant to
1390	chapter 651, Florida Statutes.
1391	(4)(a)  This moratorium on certificates of need shall not
1392	apply, and a certificate of need for additional community
1393	nursing home beds may be approved, for a county that meets the
1394	following circumstances:
1395	1.  The county has no community nursing home beds; and
1396	2.  The lack of community nursing home beds occurs because
1397	all nursing home beds in the county which were licensed on July
1398	1, 2001, have subsequently closed.
1399	(b)  The certificate-of-need review for such circumstances
1400	shall be subject to the comparative review process consistent
1401	with the provisions of section 408.039, Florida Statutes, and
1402	the number of beds may not exceed the number of beds lost by the
1403	county after July 1, 2001.
1404
1405	This subsection shall be repealed upon the expiration of the
1406	moratorium established in subsection (1).
1407	(5)  This moratorium on certificates of need shall not
1408	apply for the addition of nursing home beds licensed under
1409	chapter 400 to a nursing home located in a county having up to
1410	50,000 residents, in a number not exceeding 10 total beds or 10
1411	percent of the number of beds licensed in the facility being
1412	expanded, whichever is greater. In addition to any other
1413	documentation required by the agency, a request submitted under
1414	this paragraph must:
1415	(a)  Certify that the facility has not had any class I or
1416	class II deficiencies within the 30 months preceding the request
1417	for addition.
1418	(b)  Certify that the prior 12-month average occupancy rate
1419	for the nursing home beds at the facility meets or exceeds 94
1420	percent and the facility had not had any class I or class II
1421	deficiencies since its initial licensure.
1422	(c)  For a facility that has been licensed for less than 24
1423	months, certify that the prior 6-month average occupancy rate
1424	for the nursing home beds at the facility meets or exceeds 94
1425	percent and that the facility has not had any class I or class
1426	II deficiencies since its initial licensure.
1427
1428	This subsection shall be repealed upon the expiration of the
1429	moratorium established in subsection (1).
1430	Section 15.  This act shall take effect July 1, 2004.

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