HB 565

1	A bill to be entitled
2	An act relating to Medicaid Pharmaceutical and
3	Therapeutics Committees; amending s. 409.91195, F.S.;
4	renaming the Medicaid Pharmaceutical and Therapeutics
5	Committee as the Adult Medicaid Pharmaceutical and
6	Therapeutics Committee; revising the term and membership
7	requirements of the committee; creating the Pediatric
8	Medicaid Pharmaceutical and Therapeutics Committee within
9	the Agency for Health Care Administration; providing for
10	membership and terms; providing for duties and
11	requirements of the committee; amending ss. 409.91196 and
12	409.912, F.S.; conforming references; providing an
13	effective date.
14
15	Be It Enacted by the Legislature of the State of Florida:
16
17	Section 1.  Section 409.91195, Florida Statutes, is amended
18	to read:
19	409.91195  Medicaid Pharmaceutical and Therapeutics
20	Committees Committee.--There is created an Adult a Medicaid
21	Pharmaceutical and Therapeutics Committee and a Pediatric
22	Medicaid Pharmaceutical and Therapeutics Committee within the
23	agency for the purpose of developing a Medicaid preferred drug
24	list.
25	(1)(a)  The Adult Medicaid Pharmaceutical and Therapeutics
26	Committee shall be composed of 11 members appointed by the
27	Governor. Four members shall be physicians, licensed under
28	chapter 458; one member licensed under chapter 459; five members
29	shall be pharmacists licensed under chapter 465; and one member
30	shall be a consumer representative. The members shall be
31	appointed to serve for terms of 2 years staggered from the date
32	of their appointment. Members may be appointed to more than one
33	term. The agency shall serve as staff for the committee and
34	assist them with all ministerial duties. The Governor shall
35	ensure that all at least some of the members of the committee,
36	except for the consumer representative member, represent
37	Medicaid participating physicians and pharmacies serving all
38	segments and diversity of the adult Medicaid population, and
39	have experience in either developing or practicing under a
40	preferred drug list. At least One of the members shall represent
41	the interests of pharmaceutical manufacturers.
42	(b)  The Pediatric Medicaid Pharmaceutical and Therapeutics
43	Committee shall be composed of 11 members appointed by the
44	Governor. Four members shall be actively practicing board
45	certified pediatricians licensed under chapter 458; one member
46	shall be a physician licensed under chapter 459 actively
47	practicing pediatrics; five members shall be pharmacists
48	licensed under chapter 465, three of whom shall actively
49	practice in children's hospitals and related institutions; and
50	one member shall be a consumer representative. The physician
51	members shall include two general pediatric practitioners, a
52	pediatric subspecialist and a child psychiatrist, all of whom
53	shall maintain appropriate board certification. Three of the
54	physician members shall also have at least a 25-percent or
55	greater representation of Medicaid patients within their
56	practice. The members shall be appointed to serve terms of 2
57	years staggered from the date of their appointment. Members may
58	be appointed to more than one term. The agency shall serve as
59	staff for the committee and assist them with all ministerial
60	duties. The Governor shall ensure that all of the members of the
61	committee, except for the consumer representative member,
62	represent Medicaid participating physicians and pharmacies
63	serving all segments and diversity of the child Medicaid
64	population and shall have experience in either developing or
65	practicing under a preferred drug list. One of the pharmacy
66	members shall represent the interests of pharmaceutical
67	manufacturers.
68	(2)  Committee members shall select a chairperson and a
69	vice chairperson each year from the committee membership.
70	(3)  Each The committee shall meet at least quarterly and
71	may meet at other times at the discretion of the chairperson and
72	members. The committees committee shall comply with rules
73	adopted by the agency, including notice of any meeting of the
74	committees committee pursuant to the requirements of the
75	Administrative Procedure Act.
76	(4)  Upon recommendation of the committees committee, the
77	agency shall adopt a preferred drug list as described in s.
78	409.912(39). To the extent feasible, the committees committee
79	shall review all drug classes included on the preferred drug
80	list every 12 months, and may recommend additions to and
81	deletions from the preferred drug list, such that the preferred
82	drug list provides for medically appropriate drug therapies for
83	Medicaid patients which achieve cost savings contained in the
84	General Appropriations Act.
85	(5)  Except for antiretroviral drugs and drugs specifically
86	recommended by the committees to be exempt from prior
87	authorization, reimbursement of drugs not included on the
88	preferred drug list is subject to prior authorization.
89	(6)  The agency shall publish and disseminate the preferred
90	drug list to all Medicaid providers in the state by Internet
91	posting on the agency's website or in other media.
92	(7)  The committees committee shall ensure that interested
93	parties, including pharmaceutical manufacturers agreeing to
94	provide a supplemental rebate as outlined in this chapter, have
95	an opportunity to present public testimony to the committees
96	committee with information or evidence supporting inclusion of a
97	product on the preferred drug list. Such public testimony shall
98	occur prior to any recommendations made by the committees
99	committee for inclusion or exclusion from the preferred drug
100	list. Upon timely notice, the agency shall ensure that any drug
101	that has been approved or had any of its particular uses
102	approved by the United States Food and Drug Administration under
103	a priority review classification will be reviewed by the
104	committees committee at the next regularly scheduled meeting
105	following 3 months of distribution of the drug to the general
106	public.
107	(8)  Each The committee shall develop its preferred drug
108	list recommendations by considering the clinical efficacy,
109	safety, and cost-effectiveness of a product.
110	(9)  Upon timely notice, the agency shall ensure that any
111	therapeutic class of drugs which includes a drug that has been
112	removed from distribution to the public by its manufacturer or
113	the United States Food and Drug Administration or has been
114	required to carry a black box warning label by the United States
115	Food and Drug Administration because of safety concerns is
116	reviewed by each the committee at the next regularly scheduled
117	meeting. After such review, each the committee must recommend
118	whether to retain the therapeutic class of drugs or
119	subcategories of drugs within a therapeutic class on the
120	preferred drug list and whether to institute prior authorization
121	requirements necessary to ensure patient safety.
122	(10)  Each The Medicaid Pharmaceutical and Therapeutics
123	committee may also make recommendations to the agency regarding
124	the prior authorization of any prescribed drug covered by
125	Medicaid.
126	(11)  Medicaid recipients may appeal agency preferred drug
127	formulary decisions using the Medicaid fair hearing process
128	administered by the Department of Children and Family Services.
129	Section 2.  Subsection (2) of section 409.91196, Florida
130	Statutes, is amended to read:
131	409.91196  Supplemental rebate agreements; public records
132	and public meetings exemption.--
133	(2)  That portion of a meeting of the Adult Medicaid
134	Pharmaceutical and Therapeutics Committee or the Pediatric
135	Medicaid Pharmaceutical and Therapeutics Committee at which the
136	rebate amount, percent of rebate, manufacturer's pricing, or
137	supplemental rebate, or other trade secrets as defined in s.
138	688.002 that the agency has identified for use in negotiations,
139	are discussed is exempt from s. 286.011 and s. 24(b), Art. I of
140	the State Constitution. A record shall be made of each exempt
141	portion of a meeting. Such record must include the times of
142	commencement and termination, all discussions and proceedings,
143	the names of all persons present at any time, and the names of
144	all persons speaking. No exempt portion of a meeting may be held
145	off the record.
146	Section 3.  Section 409.912, Florida Statutes, is amended
147	to read:
148	409.912  Cost-effective purchasing of health care.--The
149	agency shall purchase goods and services for Medicaid recipients
150	in the most cost-effective manner consistent with the delivery
151	of quality medical care. To ensure that medical services are
152	effectively utilized, the agency may, in any case, require a
153	confirmation or second physician's opinion of the correct
154	diagnosis for purposes of authorizing future services under the
155	Medicaid program. This section does not restrict access to
156	emergency services or poststabilization care services as defined
157	in 42 C.F.R. part 438.114. Such confirmation or second opinion
158	shall be rendered in a manner approved by the agency. The agency
159	shall maximize the use of prepaid per capita and prepaid
160	aggregate fixed-sum basis services when appropriate and other
161	alternative service delivery and reimbursement methodologies,
162	including competitive bidding pursuant to s. 287.057, designed
163	to facilitate the cost-effective purchase of a case-managed
164	continuum of care. The agency shall also require providers to
165	minimize the exposure of recipients to the need for acute
166	inpatient, custodial, and other institutional care and the
167	inappropriate or unnecessary use of high-cost services. The
168	agency shall contract with a vendor to monitor and evaluate the
169	clinical practice patterns of providers in order to identify
170	trends that are outside the normal practice patterns of a
171	provider's professional peers or the national guidelines of a
172	provider's professional association. The vendor must be able to
173	provide information and counseling to a provider whose practice
174	patterns are outside the norms, in consultation with the agency,
175	to improve patient care and reduce inappropriate utilization.
176	The agency may mandate prior authorization, drug therapy
177	management, or disease management participation for certain
178	populations of Medicaid beneficiaries, certain drug classes, or
179	particular drugs to prevent fraud, abuse, overuse, and possible
180	dangerous drug interactions. The Adult Medicaid Pharmaceutical
181	and Therapeutics Committee and the Pediatric Medicaid
182	Pharmaceutical and Therapeutics Committee shall make
183	recommendations to the agency on drugs for which prior
184	authorization is required. The agency shall inform the
185	committees Pharmaceutical and Therapeutics Committee of its
186	decisions regarding drugs subject to prior authorization. The
187	agency is authorized to limit the entities it contracts with or
188	enrolls as Medicaid providers by developing a provider network
189	through provider credentialing. The agency may competitively bid
190	single-source-provider contracts if procurement of goods or
191	services results in demonstrated cost savings to the state
192	without limiting access to care. The agency may limit its
193	network based on the assessment of beneficiary access to care,
194	provider availability, provider quality standards, time and
195	distance standards for access to care, the cultural competence
196	of the provider network, demographic characteristics of Medicaid
197	beneficiaries, practice and provider-to-beneficiary standards,
198	appointment wait times, beneficiary use of services, provider
199	turnover, provider profiling, provider licensure history,
200	previous program integrity investigations and findings, peer
201	review, provider Medicaid policy and billing compliance records,
202	clinical and medical record audits, and other factors. Providers
203	shall not be entitled to enrollment in the Medicaid provider
204	network. The agency shall determine instances in which allowing
205	Medicaid beneficiaries to purchase durable medical equipment and
206	other goods is less expensive to the Medicaid program than long-
207	term rental of the equipment or goods. The agency may establish
208	rules to facilitate purchases in lieu of long-term rentals in
209	order to protect against fraud and abuse in the Medicaid program
210	as defined in s. 409.913. The agency may seek federal waivers
211	necessary to administer these policies.
212	(1)  The agency shall work with the Department of Children
213	and Family Services to ensure access of children and families in
214	the child protection system to needed and appropriate mental
215	health and substance abuse services.
216	(2)  The agency may enter into agreements with appropriate
217	agents of other state agencies or of any agency of the Federal
218	Government and accept such duties in respect to social welfare
219	or public aid as may be necessary to implement the provisions of
220	Title XIX of the Social Security Act and ss. 409.901-409.920.
221	(3)  The agency may contract with health maintenance
222	organizations certified pursuant to part I of chapter 641 for
223	the provision of services to recipients.
224	(4)  The agency may contract with:
225	(a)  An entity that provides no prepaid health care
226	services other than Medicaid services under contract with the
227	agency and which is owned and operated by a county, county
228	health department, or county-owned and operated hospital to
229	provide health care services on a prepaid or fixed-sum basis to
230	recipients, which entity may provide such prepaid services
231	either directly or through arrangements with other providers.
232	Such prepaid health care services entities must be licensed
233	under parts I and III of chapter 641. An entity recognized under
234	this paragraph which demonstrates to the satisfaction of the
235	Office of Insurance Regulation of the Financial Services
236	Commission that it is backed by the full faith and credit of the
237	county in which it is located may be exempted from s. 641.225.
238	(b)  An entity that is providing comprehensive behavioral
239	health care services to certain Medicaid recipients through a
240	capitated, prepaid arrangement pursuant to the federal waiver
241	provided for by s. 409.905(5). Such an entity must be licensed
242	under chapter 624, chapter 636, or chapter 641 and must possess
243	the clinical systems and operational competence to manage risk
244	and provide comprehensive behavioral health care to Medicaid
245	recipients. As used in this paragraph, the term "comprehensive
246	behavioral health care services" means covered mental health and
247	substance abuse treatment services that are available to
248	Medicaid recipients. The secretary of the Department of Children
249	and Family Services shall approve provisions of procurements
250	related to children in the department's care or custody prior to
251	enrolling such children in a prepaid behavioral health plan. Any
252	contract awarded under this paragraph must be competitively
253	procured. In developing the behavioral health care prepaid plan
254	procurement document, the agency shall ensure that the
255	procurement document requires the contractor to develop and
256	implement a plan to ensure compliance with s. 394.4574 related
257	to services provided to residents of licensed assisted living
258	facilities that hold a limited mental health license. Except as
259	provided in subparagraph 8., and except in counties where the
260	Medicaid managed care pilot program is authorized pursuant to s.
261	409.91211, the agency shall seek federal approval to contract
262	with a single entity meeting these requirements to provide
263	comprehensive behavioral health care services to all Medicaid
264	recipients not enrolled in a Medicaid managed care plan
265	authorized under s. 409.91211 or a Medicaid health maintenance
266	organization in an AHCA area. In an AHCA area where the Medicaid
267	managed care pilot program is authorized pursuant to s.
268	409.91211 in one or more counties, the agency may procure a
269	contract with a single entity to serve the remaining counties as
270	an AHCA area or the remaining counties may be included with an
271	adjacent AHCA area and shall be subject to this paragraph. Each
272	entity must offer sufficient choice of providers in its network
273	to ensure recipient access to care and the opportunity to select
274	a provider with whom they are satisfied. The network shall
275	include all public mental health hospitals. To ensure unimpaired
276	access to behavioral health care services by Medicaid
277	recipients, all contracts issued pursuant to this paragraph
278	shall require 80 percent of the capitation paid to the managed
279	care plan, including health maintenance organizations, to be
280	expended for the provision of behavioral health care services.
281	In the event the managed care plan expends less than 80 percent
282	of the capitation paid pursuant to this paragraph for the
283	provision of behavioral health care services, the difference
284	shall be returned to the agency. The agency shall provide the
285	managed care plan with a certification letter indicating the
286	amount of capitation paid during each calendar year for the
287	provision of behavioral health care services pursuant to this
288	section. The agency may reimburse for substance abuse treatment
289	services on a fee-for-service basis until the agency finds that
290	adequate funds are available for capitated, prepaid
291	arrangements.
292	1.  By January 1, 2001, the agency shall modify the
293	contracts with the entities providing comprehensive inpatient
294	and outpatient mental health care services to Medicaid
295	recipients in Hillsborough, Highlands, Hardee, Manatee, and Polk
296	Counties, to include substance abuse treatment services.
297	2.  By July 1, 2003, the agency and the Department of
298	Children and Family Services shall execute a written agreement
299	that requires collaboration and joint development of all policy,
300	budgets, procurement documents, contracts, and monitoring plans
301	that have an impact on the state and Medicaid community mental
302	health and targeted case management programs.
303	3.  Except as provided in subparagraph 8., by July 1, 2006,
304	the agency and the Department of Children and Family Services
305	shall contract with managed care entities in each AHCA area
306	except area 6 or arrange to provide comprehensive inpatient and
307	outpatient mental health and substance abuse services through
308	capitated prepaid arrangements to all Medicaid recipients who
309	are eligible to participate in such plans under federal law and
310	regulation. In AHCA areas where eligible individuals number less
311	than 150,000, the agency shall contract with a single managed
312	care plan to provide comprehensive behavioral health services to
313	all recipients who are not enrolled in a Medicaid health
314	maintenance organization or a Medicaid capitated managed care
315	plan authorized under s. 409.91211. The agency may contract with
316	more than one comprehensive behavioral health provider to
317	provide care to recipients who are not enrolled in a Medicaid
318	capitated managed care plan authorized under s. 409.91211 or a
319	Medicaid health maintenance organization in AHCA areas where the
320	eligible population exceeds 150,000. In an AHCA area where the
321	Medicaid managed care pilot program is authorized pursuant to s.
322	409.91211 in one or more counties, the agency may procure a
323	contract with a single entity to serve the remaining counties as
324	an AHCA area or the remaining counties may be included with an
325	adjacent AHCA area and shall be subject to this paragraph.
326	Contracts for comprehensive behavioral health providers awarded
327	pursuant to this section shall be competitively procured. Both
328	for-profit and not-for-profit corporations shall be eligible to
329	compete. Managed care plans contracting with the agency under
330	subsection (3) shall provide and receive payment for the same
331	comprehensive behavioral health benefits as provided in AHCA
332	rules, including handbooks incorporated by reference. In AHCA
333	area 11, the agency shall contract with at least two
334	comprehensive behavioral health care providers to provide
335	behavioral health care to recipients in that area who are
336	enrolled in, or assigned to, the MediPass program. One of the
337	behavioral health care contracts shall be with the existing
338	provider service network pilot project, as described in
339	paragraph (d), for the purpose of demonstrating the cost-
340	effectiveness of the provision of quality mental health services
341	through a public hospital-operated managed care model. Payment
342	shall be at an agreed-upon capitated rate to ensure cost
343	savings. Of the recipients in area 11 who are assigned to
344	MediPass under the provisions of s. 409.9122(2)(k), a minimum of
345	50,000 of those MediPass-enrolled recipients shall be assigned
346	to the existing provider service network in area 11 for their
347	behavioral care.
348	4.  By October 1, 2003, the agency and the department shall
349	submit a plan to the Governor, the President of the Senate, and
350	the Speaker of the House of Representatives which provides for
351	the full implementation of capitated prepaid behavioral health
352	care in all areas of the state.
353	a.  Implementation shall begin in 2003 in those AHCA areas
354	of the state where the agency is able to establish sufficient
355	capitation rates.
356	b.  If the agency determines that the proposed capitation
357	rate in any area is insufficient to provide appropriate
358	services, the agency may adjust the capitation rate to ensure
359	that care will be available. The agency and the department may
360	use existing general revenue to address any additional required
361	match but may not over-obligate existing funds on an annualized
362	basis.
363	c.  Subject to any limitations provided for in the General
364	Appropriations Act, the agency, in compliance with appropriate
365	federal authorization, shall develop policies and procedures
366	that allow for certification of local and state funds.
367	5.  Children residing in a statewide inpatient psychiatric
368	program, or in a Department of Juvenile Justice or a Department
369	of Children and Family Services residential program approved as
370	a Medicaid behavioral health overlay services provider shall not
371	be included in a behavioral health care prepaid health plan or
372	any other Medicaid managed care plan pursuant to this paragraph.
373	6.  In converting to a prepaid system of delivery, the
374	agency shall in its procurement document require an entity
375	providing only comprehensive behavioral health care services to
376	prevent the displacement of indigent care patients by enrollees
377	in the Medicaid prepaid health plan providing behavioral health
378	care services from facilities receiving state funding to provide
379	indigent behavioral health care, to facilities licensed under
380	chapter 395 which do not receive state funding for indigent
381	behavioral health care, or reimburse the unsubsidized facility
382	for the cost of behavioral health care provided to the displaced
383	indigent care patient.
384	7.  Traditional community mental health providers under
385	contract with the Department of Children and Family Services
386	pursuant to part IV of chapter 394, child welfare providers
387	under contract with the Department of Children and Family
388	Services in areas 1 and 6, and inpatient mental health providers
389	licensed pursuant to chapter 395 must be offered an opportunity
390	to accept or decline a contract to participate in any provider
391	network for prepaid behavioral health services.
392	8.  For fiscal year 2004-2005, all Medicaid eligible
393	children, except children in areas 1 and 6, whose cases are open
394	for child welfare services in the HomeSafeNet system, shall be
395	enrolled in MediPass or in Medicaid fee-for-service and all
396	their behavioral health care services including inpatient,
397	outpatient psychiatric, community mental health, and case
398	management shall be reimbursed on a fee-for-service basis.
399	Beginning July 1, 2005, such children, who are open for child
400	welfare services in the HomeSafeNet system, shall receive their
401	behavioral health care services through a specialty prepaid plan
402	operated by community-based lead agencies either through a
403	single agency or formal agreements among several agencies. The
404	specialty prepaid plan must result in savings to the state
405	comparable to savings achieved in other Medicaid managed care
406	and prepaid programs. Such plan must provide mechanisms to
407	maximize state and local revenues. The specialty prepaid plan
408	shall be developed by the agency and the Department of Children
409	and Family Services. The agency is authorized to seek any
410	federal waivers to implement this initiative.
411	(c)  A federally qualified health center or an entity owned
412	by one or more federally qualified health centers or an entity
413	owned by other migrant and community health centers receiving
414	non-Medicaid financial support from the Federal Government to
415	provide health care services on a prepaid or fixed-sum basis to
416	recipients. A federally qualified health center or an entity
417	that is owned by one or more federally qualified health centers
418	and is reimbursed by the agency on a prepaid basis is exempt
419	from parts I and III of chapter 641, but must comply with the
420	solvency requirements in s. 641.2261(2) and meet the appropriate
421	requirements governing financial reserve, quality assurance, and
422	patients' rights established by the agency.
423	(d)  A provider service network may be reimbursed on a fee-
424	for-service or prepaid basis. A provider service network which
425	is reimbursed by the agency on a prepaid basis shall be exempt
426	from parts I and III of chapter 641, but must comply with the
427	solvency requirements in s. 641.2261(2) and meet appropriate
428	financial reserve, quality assurance, and patient rights
429	requirements as established by the agency. Medicaid recipients
430	assigned to a provider service network shall be chosen equally
431	from those who would otherwise have been assigned to prepaid
432	plans and MediPass. The agency is authorized to seek federal
433	Medicaid waivers as necessary to implement the provisions of
434	this section. Any contract previously awarded to a provider
435	service network operated by a hospital pursuant to this
436	subsection shall remain in effect for a period of 3 years
437	following the current contract expiration date, regardless of
438	any contractual provisions to the contrary. A provider service
439	network is a network established or organized and operated by a
440	health care provider, or group of affiliated health care
441	providers, including minority physician networks and emergency
442	room diversion programs that meet the requirements of s.
443	409.91211, which provides a substantial proportion of the health
444	care items and services under a contract directly through the
445	provider or affiliated group of providers and may make
446	arrangements with physicians or other health care professionals,
447	health care institutions, or any combination of such individuals
448	or institutions to assume all or part of the financial risk on a
449	prospective basis for the provision of basic health services by
450	the physicians, by other health professionals, or through the
451	institutions. The health care providers must have a controlling
452	interest in the governing body of the provider service network
453	organization.
454	(e)  An entity that provides only comprehensive behavioral
455	health care services to certain Medicaid recipients through an
456	administrative services organization agreement. Such an entity
457	must possess the clinical systems and operational competence to
458	provide comprehensive health care to Medicaid recipients. As
459	used in this paragraph, the term "comprehensive behavioral
460	health care services" means covered mental health and substance
461	abuse treatment services that are available to Medicaid
462	recipients. Any contract awarded under this paragraph must be
463	competitively procured. The agency must ensure that Medicaid
464	recipients have available the choice of at least two managed
465	care plans for their behavioral health care services.
466	(f)  An entity that provides in-home physician services to
467	test the cost-effectiveness of enhanced home-based medical care
468	to Medicaid recipients with degenerative neurological diseases
469	and other diseases or disabling conditions associated with high
470	costs to Medicaid. The program shall be designed to serve very
471	disabled persons and to reduce Medicaid reimbursed costs for
472	inpatient, outpatient, and emergency department services. The
473	agency shall contract with vendors on a risk-sharing basis.
474	(g)  Children's provider networks that provide care
475	coordination and care management for Medicaid-eligible pediatric
476	patients, primary care, authorization of specialty care, and
477	other urgent and emergency care through organized providers
478	designed to service Medicaid eligibles under age 18 and
479	pediatric emergency departments' diversion programs. The
480	networks shall provide after-hour operations, including evening
481	and weekend hours, to promote, when appropriate, the use of the
482	children's networks rather than hospital emergency departments.
483	(h)  An entity authorized in s. 430.205 to contract with
484	the agency and the Department of Elderly Affairs to provide
485	health care and social services on a prepaid or fixed-sum basis
486	to elderly recipients. Such prepaid health care services
487	entities are exempt from the provisions of part I of chapter 641
488	for the first 3 years of operation. An entity recognized under
489	this paragraph that demonstrates to the satisfaction of the
490	Office of Insurance Regulation that it is backed by the full
491	faith and credit of one or more counties in which it operates
492	may be exempted from s. 641.225.
493	(i)  A Children's Medical Services Network, as defined in
494	s. 391.021.
495	(5)  By December 1, 2005, the Agency for Health Care
496	Administration, in partnership with the Department of Elderly
497	Affairs, shall create an integrated, fixed-payment delivery
498	system for Medicaid recipients who are 60 years of age or older.
499	The Agency for Health Care Administration shall implement the
500	integrated system initially on a pilot basis in two areas of the
501	state. In one of the areas enrollment shall be on a voluntary
502	basis. The program must transfer all Medicaid services for
503	eligible elderly individuals who choose to participate into an
504	integrated-care management model designed to serve Medicaid
505	recipients in the community. The program must combine all
506	funding for Medicaid services provided to individuals 60 years
507	of age or older into the integrated system, including funds for
508	Medicaid home and community-based waiver services; all Medicaid
509	services authorized in ss. 409.905 and 409.906, excluding funds
510	for Medicaid nursing home services unless the agency is able to
511	demonstrate how the integration of the funds will improve
512	coordinated care for these services in a less costly manner; and
513	Medicare coinsurance and deductibles for persons dually eligible
514	for Medicaid and Medicare as prescribed in s. 409.908(13).
515	(a)  Individuals who are 60 years of age or older and
516	enrolled in the developmental disabilities waiver program, the
517	family and supported-living waiver program, the project AIDS
518	care waiver program, the traumatic brain injury and spinal cord
519	injury waiver program, the consumer-directed care waiver
520	program, and the program of all-inclusive care for the elderly
521	program, and residents of institutional care facilities for the
522	developmentally disabled, must be excluded from the integrated
523	system.
524	(b)  The program must use a competitive procurement process
525	to select entities to operate the integrated system. Entities
526	eligible to submit bids include managed care organizations
527	licensed under chapter 641, including entities eligible to
528	participate in the nursing home diversion program, other
529	qualified providers as defined in s. 430.703(7), community care
530	for the elderly lead agencies, and other state-certified
531	community service networks that meet comparable standards as
532	defined by the agency, in consultation with the Department of
533	Elderly Affairs and the Office of Insurance Regulation, to be
534	financially solvent and able to take on financial risk for
535	managed care. Community service networks that are certified
536	pursuant to the comparable standards defined by the agency are
537	not required to be licensed under chapter 641.
538	(c)  The agency must ensure that the capitation-rate-
539	setting methodology for the integrated system is actuarially
540	sound and reflects the intent to provide quality care in the
541	least restrictive setting. The agency must also require
542	integrated-system providers to develop a credentialing system
543	for service providers and to contract with all Gold Seal nursing
544	homes, where feasible, and exclude, where feasible, chronically
545	poor-performing facilities and providers as defined by the
546	agency. The integrated system must provide that if the recipient
547	resides in a noncontracted residential facility licensed under
548	chapter 400 or chapter 429 at the time the integrated system is
549	initiated, the recipient must be permitted to continue to reside
550	in the noncontracted facility as long as the recipient desires.
551	The integrated system must also provide that, in the absence of
552	a contract between the integrated-system provider and the
553	residential facility licensed under chapter 400 or chapter 429,
554	current Medicaid rates must prevail. The agency and the
555	Department of Elderly Affairs must jointly develop procedures to
556	manage the services provided through the integrated system in
557	order to ensure quality and recipient choice.
558	(d)  Within 24 months after implementation, the Office of
559	Program Policy Analysis and Government Accountability, in
560	consultation with the Auditor General, shall comprehensively
561	evaluate the pilot project for the integrated, fixed-payment
562	delivery system for Medicaid recipients who are 60 years of age
563	or older. The evaluation must include assessments of cost
564	savings; consumer education, choice, and access to services;
565	coordination of care; and quality of care. The evaluation must
566	describe administrative or legal barriers to the implementation
567	and operation of the pilot program and include recommendations
568	regarding statewide expansion of the pilot program. The office
569	shall submit an evaluation report to the Governor, the President
570	of the Senate, and the Speaker of the House of Representatives
571	no later than June 30, 2008.
572	(e)  The agency may seek federal waivers and adopt rules as
573	necessary to administer the integrated system. The agency must
574	receive specific authorization from the Legislature prior to
575	implementing the waiver for the integrated system.
576	(6)  The agency may contract with any public or private
577	entity otherwise authorized by this section on a prepaid or
578	fixed-sum basis for the provision of health care services to
579	recipients. An entity may provide prepaid services to
580	recipients, either directly or through arrangements with other
581	entities, if each entity involved in providing services:
582	(a)  Is organized primarily for the purpose of providing
583	health care or other services of the type regularly offered to
584	Medicaid recipients;
585	(b)  Ensures that services meet the standards set by the
586	agency for quality, appropriateness, and timeliness;
587	(c)  Makes provisions satisfactory to the agency for
588	insolvency protection and ensures that neither enrolled Medicaid
589	recipients nor the agency will be liable for the debts of the
590	entity;
591	(d)  Submits to the agency, if a private entity, a
592	financial plan that the agency finds to be fiscally sound and
593	that provides for working capital in the form of cash or
594	equivalent liquid assets excluding revenues from Medicaid
595	premium payments equal to at least the first 3 months of
596	operating expenses or $200,000, whichever is greater;
597	(e)  Furnishes evidence satisfactory to the agency of
598	adequate liability insurance coverage or an adequate plan of
599	self-insurance to respond to claims for injuries arising out of
600	the furnishing of health care;
601	(f)  Provides, through contract or otherwise, for periodic
602	review of its medical facilities and services, as required by
603	the agency; and
604	(g)  Provides organizational, operational, financial, and
605	other information required by the agency.
606	(7)  The agency may contract on a prepaid or fixed-sum
607	basis with any health insurer that:
608	(a)  Pays for health care services provided to enrolled
609	Medicaid recipients in exchange for a premium payment paid by
610	the agency;
611	(b)  Assumes the underwriting risk; and
612	(c)  Is organized and licensed under applicable provisions
613	of the Florida Insurance Code and is currently in good standing
614	with the Office of Insurance Regulation.
615	(8)  The agency may contract on a prepaid or fixed-sum
616	basis with an exclusive provider organization to provide health
617	care services to Medicaid recipients provided that the exclusive
618	provider organization meets applicable managed care plan
619	requirements in this section, ss. 409.9122, 409.9123, 409.9128,
620	and 627.6472, and other applicable provisions of law.
621	(9)  The Agency for Health Care Administration may provide
622	cost-effective purchasing of chiropractic services on a fee-for-
623	service basis to Medicaid recipients through arrangements with a
624	statewide chiropractic preferred provider organization
625	incorporated in this state as a not-for-profit corporation. The
626	agency shall ensure that the benefit limits and prior
627	authorization requirements in the current Medicaid program shall
628	apply to the services provided by the chiropractic preferred
629	provider organization.
630	(10)  The agency shall not contract on a prepaid or fixed-
631	sum basis for Medicaid services with an entity which knows or
632	reasonably should know that any officer, director, agent,
633	managing employee, or owner of stock or beneficial interest in
634	excess of 5 percent common or preferred stock, or the entity
635	itself, has been found guilty of, regardless of adjudication, or
636	entered a plea of nolo contendere, or guilty, to:
637	(a)  Fraud;
638	(b)  Violation of federal or state antitrust statutes,
639	including those proscribing price fixing between competitors and
640	the allocation of customers among competitors;
641	(c)  Commission of a felony involving embezzlement, theft,
642	forgery, income tax evasion, bribery, falsification or
643	destruction of records, making false statements, receiving
644	stolen property, making false claims, or obstruction of justice;
645	or
646	(d)  Any crime in any jurisdiction which directly relates
647	to the provision of health services on a prepaid or fixed-sum
648	basis.
649	(11)  The agency, after notifying the Legislature, may
650	apply for waivers of applicable federal laws and regulations as
651	necessary to implement more appropriate systems of health care
652	for Medicaid recipients and reduce the cost of the Medicaid
653	program to the state and federal governments and shall implement
654	such programs, after legislative approval, within a reasonable
655	period of time after federal approval. These programs must be
656	designed primarily to reduce the need for inpatient care,
657	custodial care and other long-term or institutional care, and
658	other high-cost services. Prior to seeking legislative approval
659	of such a waiver as authorized by this subsection, the agency
660	shall provide notice and an opportunity for public comment.
661	Notice shall be provided to all persons who have made requests
662	of the agency for advance notice and shall be published in the
663	Florida Administrative Weekly not less than 28 days prior to the
664	intended action.
665	(12)  The agency shall establish a postpayment utilization
666	control program designed to identify recipients who may
667	inappropriately overuse or underuse Medicaid services and shall
668	provide methods to correct such misuse.
669	(13)  The agency shall develop and provide coordinated
670	systems of care for Medicaid recipients and may contract with
671	public or private entities to develop and administer such
672	systems of care among public and private health care providers
673	in a given geographic area.
674	(14)(a)  The agency shall operate or contract for the
675	operation of utilization management and incentive systems
676	designed to encourage cost-effective use services.
677	(b)  The agency shall develop a procedure for determining
678	whether health care providers and service vendors can provide
679	the Medicaid program using a business case that demonstrates
680	whether a particular good or service can offset the cost of
681	providing the good or service in an alternative setting or
682	through other means and therefore should receive a higher
683	reimbursement. The business case must include, but need not be
684	limited to:
685	1.  A detailed description of the good or service to be
686	provided, a description and analysis of the agency's current
687	performance of the service, and a rationale documenting how
688	providing the service in an alternative setting would be in the
689	best interest of the state, the agency, and its clients.
690	2.  A cost-benefit analysis documenting the estimated
691	specific direct and indirect costs, savings, performance
692	improvements, risks, and qualitative and quantitative benefits
693	involved in or resulting from providing the service. The cost-
694	benefit analysis must include a detailed plan and timeline
695	identifying all actions that must be implemented to realize
696	expected benefits. The Secretary of Health Care Administration
697	shall verify that all costs, savings, and benefits are valid and
698	achievable.
699	(c)  If the agency determines that the increased
700	reimbursement is cost-effective, the agency shall recommend a
701	change in the reimbursement schedule for that particular good or
702	service. If, within 12 months after implementing any rate change
703	under this procedure, the agency determines that costs were not
704	offset by the increased reimbursement schedule, the agency may
705	revert to the former reimbursement schedule for the particular
706	good or service.
707	(15)(a)  The agency shall operate the Comprehensive
708	Assessment and Review for Long-Term Care Services (CARES)
709	nursing facility preadmission screening program to ensure that
710	Medicaid payment for nursing facility care is made only for
711	individuals whose conditions require such care and to ensure
712	that long-term care services are provided in the setting most
713	appropriate to the needs of the person and in the most
714	economical manner possible. The CARES program shall also ensure
715	that individuals participating in Medicaid home and community-
716	based waiver programs meet criteria for those programs,
717	consistent with approved federal waivers.
718	(b)  The agency shall operate the CARES program through an
719	interagency agreement with the Department of Elderly Affairs.
720	The agency, in consultation with the Department of Elderly
721	Affairs, may contract for any function or activity of the CARES
722	program, including any function or activity required by 42
723	C.F.R. part 483.20, relating to preadmission screening and
724	resident review.
725	(c)  Prior to making payment for nursing facility services
726	for a Medicaid recipient, the agency must verify that the
727	nursing facility preadmission screening program has determined
728	that the individual requires nursing facility care and that the
729	individual cannot be safely served in community-based programs.
730	The nursing facility preadmission screening program shall refer
731	a Medicaid recipient to a community-based program if the
732	individual could be safely served at a lower cost and the
733	recipient chooses to participate in such program. For
734	individuals whose nursing home stay is initially funded by
735	Medicare and Medicare coverage is being terminated for lack of
736	progress towards rehabilitation, CARES staff shall consult with
737	the person making the determination of progress toward
738	rehabilitation to ensure that the recipient is not being
739	inappropriately disqualified from Medicare coverage. If, in
740	their professional judgment, CARES staff believes that a
741	Medicare beneficiary is still making progress toward
742	rehabilitation, they may assist the Medicare beneficiary with an
743	appeal of the disqualification from Medicare coverage. The use
744	of CARES teams to review Medicare denials for coverage under
745	this section is authorized only if it is determined that such
746	reviews qualify for federal matching funds through Medicaid. The
747	agency shall seek or amend federal waivers as necessary to
748	implement this section.
749	(d)  For the purpose of initiating immediate prescreening
750	and diversion assistance for individuals residing in nursing
751	homes and in order to make families aware of alternative long-
752	term care resources so that they may choose a more cost-
753	effective setting for long-term placement, CARES staff shall
754	conduct an assessment and review of a sample of individuals
755	whose nursing home stay is expected to exceed 20 days,
756	regardless of the initial funding source for the nursing home
757	placement. CARES staff shall provide counseling and referral
758	services to these individuals regarding choosing appropriate
759	long-term care alternatives. This paragraph does not apply to
760	continuing care facilities licensed under chapter 651 or to
761	retirement communities that provide a combination of nursing
762	home, independent living, and other long-term care services.
763	(e)  By January 15 of each year, the agency shall submit a
764	report to the Legislature describing the operations of the CARES
765	program. The report must describe:
766	1.  Rate of diversion to community alternative programs;
767	2.  CARES program staffing needs to achieve additional
768	diversions;
769	3.  Reasons the program is unable to place individuals in
770	less restrictive settings when such individuals desired such
771	services and could have been served in such settings;
772	4.  Barriers to appropriate placement, including barriers
773	due to policies or operations of other agencies or state-funded
774	programs; and
775	5.  Statutory changes necessary to ensure that individuals
776	in need of long-term care services receive care in the least
777	restrictive environment.
778	(f)  The Department of Elderly Affairs shall track
779	individuals over time who are assessed under the CARES program
780	and who are diverted from nursing home placement. By January 15
781	of each year, the department shall submit to the Legislature a
782	longitudinal study of the individuals who are diverted from
783	nursing home placement. The study must include:
784	1.  The demographic characteristics of the individuals
785	assessed and diverted from nursing home placement, including,
786	but not limited to, age, race, gender, frailty, caregiver
787	status, living arrangements, and geographic location;
788	2.  A summary of community services provided to individuals
789	for 1 year after assessment and diversion;
790	3.  A summary of inpatient hospital admissions for
791	individuals who have been diverted; and
792	4.  A summary of the length of time between diversion and
793	subsequent entry into a nursing home or death.
794	(g)  By July 1, 2005, the department and the Agency for
795	Health Care Administration shall report to the President of the
796	Senate and the Speaker of the House of Representatives regarding
797	the impact to the state of modifying level-of-care criteria to
798	eliminate the Intermediate II level of care.
799	(16)(a)  The agency shall identify health care utilization
800	and price patterns within the Medicaid program which are not
801	cost-effective or medically appropriate and assess the
802	effectiveness of new or alternate methods of providing and
803	monitoring service, and may implement such methods as it
804	considers appropriate. Such methods may include disease
805	management initiatives, an integrated and systematic approach
806	for managing the health care needs of recipients who are at risk
807	of or diagnosed with a specific disease by using best practices,
808	prevention strategies, clinical-practice improvement, clinical
809	interventions and protocols, outcomes research, information
810	technology, and other tools and resources to reduce overall
811	costs and improve measurable outcomes.
812	(b)  The responsibility of the agency under this subsection
813	shall include the development of capabilities to identify actual
814	and optimal practice patterns; patient and provider educational
815	initiatives; methods for determining patient compliance with
816	prescribed treatments; fraud, waste, and abuse prevention and
817	detection programs; and beneficiary case management programs.
818	1.  The practice pattern identification program shall
819	evaluate practitioner prescribing patterns based on national and
820	regional practice guidelines, comparing practitioners to their
821	peer groups. The agency and its Drug Utilization Review Board
822	shall consult with the Department of Health and a panel of
823	practicing health care professionals consisting of the
824	following: the Speaker of the House of Representatives and the
825	President of the Senate shall each appoint three physicians
826	licensed under chapter 458 or chapter 459; and the Governor
827	shall appoint two pharmacists licensed under chapter 465 and one
828	dentist licensed under chapter 466 who is an oral surgeon. Terms
829	of the panel members shall expire at the discretion of the
830	appointing official. The advisory panel shall be responsible for
831	evaluating treatment guidelines and recommending ways to
832	incorporate their use in the practice pattern identification
833	program. Practitioners who are prescribing inappropriately or
834	inefficiently, as determined by the agency, may have their
835	prescribing of certain drugs subject to prior authorization or
836	may be terminated from all participation in the Medicaid
837	program.
838	2.  The agency shall also develop educational interventions
839	designed to promote the proper use of medications by providers
840	and beneficiaries.
841	3.  The agency shall implement a pharmacy fraud, waste, and
842	abuse initiative that may include a surety bond or letter of
843	credit requirement for participating pharmacies, enhanced
844	provider auditing practices, the use of additional fraud and
845	abuse software, recipient management programs for beneficiaries
846	inappropriately using their benefits, and other steps that will
847	eliminate provider and recipient fraud, waste, and abuse. The
848	initiative shall address enforcement efforts to reduce the
849	number and use of counterfeit prescriptions.
850	4.  By September 30, 2002, the agency shall contract with
851	an entity in the state to implement a wireless handheld clinical
852	pharmacology drug information database for practitioners. The
853	initiative shall be designed to enhance the agency's efforts to
854	reduce fraud, abuse, and errors in the prescription drug benefit
855	program and to otherwise further the intent of this paragraph.
856	5.  By April 1, 2006, the agency shall contract with an
857	entity to design a database of clinical utilization information
858	or electronic medical records for Medicaid providers. This
859	system must be web-based and allow providers to review on a
860	real-time basis the utilization of Medicaid services, including,
861	but not limited to, physician office visits, inpatient and
862	outpatient hospitalizations, laboratory and pathology services,
863	radiological and other imaging services, dental care, and
864	patterns of dispensing prescription drugs in order to coordinate
865	care and identify potential fraud and abuse.
866	6.  The agency may apply for any federal waivers needed to
867	administer this paragraph.
868	(17)  An entity contracting on a prepaid or fixed-sum basis
869	shall, in addition to meeting any applicable statutory surplus
870	requirements, also maintain at all times in the form of cash,
871	investments that mature in less than 180 days allowable as
872	admitted assets by the Office of Insurance Regulation, and
873	restricted funds or deposits controlled by the agency or the
874	Office of Insurance Regulation, a surplus amount equal to one-
875	and-one-half times the entity's monthly Medicaid prepaid
876	revenues. As used in this subsection, the term "surplus" means
877	the entity's total assets minus total liabilities. If an
878	entity's surplus falls below an amount equal to one-and-one-half
879	times the entity's monthly Medicaid prepaid revenues, the agency
880	shall prohibit the entity from engaging in marketing and
881	preenrollment activities, shall cease to process new
882	enrollments, and shall not renew the entity's contract until the
883	required balance is achieved. The requirements of this
884	subsection do not apply:
885	(a)  Where a public entity agrees to fund any deficit
886	incurred by the contracting entity; or
887	(b)  Where the entity's performance and obligations are
888	guaranteed in writing by a guaranteeing organization which:
889	1.  Has been in operation for at least 5 years and has
890	assets in excess of $50 million; or
891	2.  Submits a written guarantee acceptable to the agency
892	which is irrevocable during the term of the contracting entity's
893	contract with the agency and, upon termination of the contract,
894	until the agency receives proof of satisfaction of all
895	outstanding obligations incurred under the contract.
896	(18)(a)  The agency may require an entity contracting on a
897	prepaid or fixed-sum basis to establish a restricted insolvency
898	protection account with a federally guaranteed financial
899	institution licensed to do business in this state. The entity
900	shall deposit into that account 5 percent of the capitation
901	payments made by the agency each month until a maximum total of
902	2 percent of the total current contract amount is reached. The
903	restricted insolvency protection account may be drawn upon with
904	the authorized signatures of two persons designated by the
905	entity and two representatives of the agency. If the agency
906	finds that the entity is insolvent, the agency may draw upon the
907	account solely with the two authorized signatures of
908	representatives of the agency, and the funds may be disbursed to
909	meet financial obligations incurred by the entity under the
910	prepaid contract. If the contract is terminated, expired, or not
911	continued, the account balance must be released by the agency to
912	the entity upon receipt of proof of satisfaction of all
913	outstanding obligations incurred under this contract.
914	(b)  The agency may waive the insolvency protection account
915	requirement in writing when evidence is on file with the agency
916	of adequate insolvency insurance and reinsurance that will
917	protect enrollees if the entity becomes unable to meet its
918	obligations.
919	(19)  An entity that contracts with the agency on a prepaid
920	or fixed-sum basis for the provision of Medicaid services shall
921	reimburse any hospital or physician that is outside the entity's
922	authorized geographic service area as specified in its contract
923	with the agency, and that provides services authorized by the
924	entity to its members, at a rate negotiated with the hospital or
925	physician for the provision of services or according to the
926	lesser of the following:
927	(a)  The usual and customary charges made to the general
928	public by the hospital or physician; or
929	(b)  The Florida Medicaid reimbursement rate established
930	for the hospital or physician.
931	(20)  When a merger or acquisition of a Medicaid prepaid
932	contractor has been approved by the Office of Insurance
933	Regulation pursuant to s. 628.4615, the agency shall approve the
934	assignment or transfer of the appropriate Medicaid prepaid
935	contract upon request of the surviving entity of the merger or
936	acquisition if the contractor and the other entity have been in
937	good standing with the agency for the most recent 12-month
938	period, unless the agency determines that the assignment or
939	transfer would be detrimental to the Medicaid recipients or the
940	Medicaid program. To be in good standing, an entity must not
941	have failed accreditation or committed any material violation of
942	the requirements of s. 641.52 and must meet the Medicaid
943	contract requirements. For purposes of this section, a merger or
944	acquisition means a change in controlling interest of an entity,
945	including an asset or stock purchase.
946	(21)  Any entity contracting with the agency pursuant to
947	this section to provide health care services to Medicaid
948	recipients is prohibited from engaging in any of the following
949	practices or activities:
950	(a)  Practices that are discriminatory, including, but not
951	limited to, attempts to discourage participation on the basis of
952	actual or perceived health status.
953	(b)  Activities that could mislead or confuse recipients,
954	or misrepresent the organization, its marketing representatives,
955	or the agency. Violations of this paragraph include, but are not
956	limited to:
957	1.  False or misleading claims that marketing
958	representatives are employees or representatives of the state or
959	county, or of anyone other than the entity or the organization
960	by whom they are reimbursed.
961	2.  False or misleading claims that the entity is
962	recommended or endorsed by any state or county agency, or by any
963	other organization which has not certified its endorsement in
964	writing to the entity.
965	3.  False or misleading claims that the state or county
966	recommends that a Medicaid recipient enroll with an entity.
967	4.  Claims that a Medicaid recipient will lose benefits
968	under the Medicaid program, or any other health or welfare
969	benefits to which the recipient is legally entitled, if the
970	recipient does not enroll with the entity.
971	(c)  Granting or offering of any monetary or other valuable
972	consideration for enrollment, except as authorized by subsection
973	(24).
974	(d)  Door-to-door solicitation of recipients who have not
975	contacted the entity or who have not invited the entity to make
976	a presentation.
977	(e)  Solicitation of Medicaid recipients by marketing
978	representatives stationed in state offices unless approved and
979	supervised by the agency or its agent and approved by the
980	affected state agency when solicitation occurs in an office of
981	the state agency. The agency shall ensure that marketing
982	representatives stationed in state offices shall market their
983	managed care plans to Medicaid recipients only in designated
984	areas and in such a way as to not interfere with the recipients'
985	activities in the state office.
986	(f)  Enrollment of Medicaid recipients.
987	(22)  The agency may impose a fine for a violation of this
988	section or the contract with the agency by a person or entity
989	that is under contract with the agency. With respect to any
990	nonwillful violation, such fine shall not exceed $2,500 per
991	violation. In no event shall such fine exceed an aggregate
992	amount of $10,000 for all nonwillful violations arising out of
993	the same action. With respect to any knowing and willful
994	violation of this section or the contract with the agency, the
995	agency may impose a fine upon the entity in an amount not to
996	exceed $20,000 for each such violation. In no event shall such
997	fine exceed an aggregate amount of $100,000 for all knowing and
998	willful violations arising out of the same action.
999	(23)  A health maintenance organization or a person or
1000	entity exempt from chapter 641 that is under contract with the
1001	agency for the provision of health care services to Medicaid
1002	recipients may not use or distribute marketing materials used to
1003	solicit Medicaid recipients, unless such materials have been
1004	approved by the agency. The provisions of this subsection do not
1005	apply to general advertising and marketing materials used by a
1006	health maintenance organization to solicit both non-Medicaid
1007	subscribers and Medicaid recipients.
1008	(24)  Upon approval by the agency, health maintenance
1009	organizations and persons or entities exempt from chapter 641
1010	that are under contract with the agency for the provision of
1011	health care services to Medicaid recipients may be permitted
1012	within the capitation rate to provide additional health benefits
1013	that the agency has found are of high quality, are practicably
1014	available, provide reasonable value to the recipient, and are
1015	provided at no additional cost to the state.
1016	(25)  The agency shall utilize the statewide health
1017	maintenance organization complaint hotline for the purpose of
1018	investigating and resolving Medicaid and prepaid health plan
1019	complaints, maintaining a record of complaints and confirmed
1020	problems, and receiving disenrollment requests made by
1021	recipients.
1022	(26)  The agency shall require the publication of the
1023	health maintenance organization's and the prepaid health plan's
1024	consumer services telephone numbers and the "800" telephone
1025	number of the statewide health maintenance organization
1026	complaint hotline on each Medicaid identification card issued by
1027	a health maintenance organization or prepaid health plan
1028	contracting with the agency to serve Medicaid recipients and on
1029	each subscriber handbook issued to a Medicaid recipient.
1030	(27)  The agency shall establish a health care quality
1031	improvement system for those entities contracting with the
1032	agency pursuant to this section, incorporating all the standards
1033	and guidelines developed by the Medicaid Bureau of the Health
1034	Care Financing Administration as a part of the quality assurance
1035	reform initiative. The system shall include, but need not be
1036	limited to, the following:
1037	(a)  Guidelines for internal quality assurance programs,
1038	including standards for:
1039	1.  Written quality assurance program descriptions.
1040	2.  Responsibilities of the governing body for monitoring,
1041	evaluating, and making improvements to care.
1042	3.  An active quality assurance committee.
1043	4.  Quality assurance program supervision.
1044	5.  Requiring the program to have adequate resources to
1045	effectively carry out its specified activities.
1046	6.  Provider participation in the quality assurance
1047	program.
1048	7.  Delegation of quality assurance program activities.
1049	8.  Credentialing and recredentialing.
1050	9.  Enrollee rights and responsibilities.
1051	10.  Availability and accessibility to services and care.
1052	11.  Ambulatory care facilities.
1053	12.  Accessibility and availability of medical records, as
1054	well as proper recordkeeping and process for record review.
1055	13.  Utilization review.
1056	14.  A continuity of care system.
1057	15.  Quality assurance program documentation.
1058	16.  Coordination of quality assurance activity with other
1059	management activity.
1060	17.  Delivering care to pregnant women and infants; to
1061	elderly and disabled recipients, especially those who are at
1062	risk of institutional placement; to persons with developmental
1063	disabilities; and to adults who have chronic, high-cost medical
1064	conditions.
1065	(b)  Guidelines which require the entities to conduct
1066	quality-of-care studies which:
1067	1.  Target specific conditions and specific health service
1068	delivery issues for focused monitoring and evaluation.
1069	2.  Use clinical care standards or practice guidelines to
1070	objectively evaluate the care the entity delivers or fails to
1071	deliver for the targeted clinical conditions and health services
1072	delivery issues.
1073	3.  Use quality indicators derived from the clinical care
1074	standards or practice guidelines to screen and monitor care and
1075	services delivered.
1076	(c)  Guidelines for external quality review of each
1077	contractor which require: focused studies of patterns of care;
1078	individual care review in specific situations; and followup
1079	activities on previous pattern-of-care study findings and
1080	individual-care-review findings. In designing the external
1081	quality review function and determining how it is to operate as
1082	part of the state's overall quality improvement system, the
1083	agency shall construct its external quality review organization
1084	and entity contracts to address each of the following:
1085	1.  Delineating the role of the external quality review
1086	organization.
1087	2.  Length of the external quality review organization
1088	contract with the state.
1089	3.  Participation of the contracting entities in designing
1090	external quality review organization review activities.
1091	4.  Potential variation in the type of clinical conditions
1092	and health services delivery issues to be studied at each plan.
1093	5.  Determining the number of focused pattern-of-care
1094	studies to be conducted for each plan.
1095	6.  Methods for implementing focused studies.
1096	7.  Individual care review.
1097	8.  Followup activities.
1098	(28)  In order to ensure that children receive health care
1099	services for which an entity has already been compensated, an
1100	entity contracting with the agency pursuant to this section
1101	shall achieve an annual Early and Periodic Screening, Diagnosis,
1102	and Treatment (EPSDT) Service screening rate of at least 60
1103	percent for those recipients continuously enrolled for at least
1104	8 months. The agency shall develop a method by which the EPSDT
1105	screening rate shall be calculated. For any entity which does
1106	not achieve the annual 60 percent rate, the entity must submit a
1107	corrective action plan for the agency's approval. If the entity
1108	does not meet the standard established in the corrective action
1109	plan during the specified timeframe, the agency is authorized to
1110	impose appropriate contract sanctions. At least annually, the
1111	agency shall publicly release the EPSDT Services screening rates
1112	of each entity it has contracted with on a prepaid basis to
1113	serve Medicaid recipients.
1114	(29)  The agency shall perform enrollments and
1115	disenrollments for Medicaid recipients who are eligible for
1116	MediPass or managed care plans. Notwithstanding the prohibition
1117	contained in paragraph (21)(f), managed care plans may perform
1118	preenrollments of Medicaid recipients under the supervision of
1119	the agency or its agents. For the purposes of this section,
1120	"preenrollment" means the provision of marketing and educational
1121	materials to a Medicaid recipient and assistance in completing
1122	the application forms, but shall not include actual enrollment
1123	into a managed care plan. An application for enrollment shall
1124	not be deemed complete until the agency or its agent verifies
1125	that the recipient made an informed, voluntary choice. The
1126	agency, in cooperation with the Department of Children and
1127	Family Services, may test new marketing initiatives to inform
1128	Medicaid recipients about their managed care options at selected
1129	sites. The agency shall report to the Legislature on the
1130	effectiveness of such initiatives. The agency may contract with
1131	a third party to perform managed care plan and MediPass
1132	enrollment and disenrollment services for Medicaid recipients
1133	and is authorized to adopt rules to implement such services. The
1134	agency may adjust the capitation rate only to cover the costs of
1135	a third-party enrollment and disenrollment contract, and for
1136	agency supervision and management of the managed care plan
1137	enrollment and disenrollment contract.
1138	(30)  Any lists of providers made available to Medicaid
1139	recipients, MediPass enrollees, or managed care plan enrollees
1140	shall be arranged alphabetically showing the provider's name and
1141	specialty and, separately, by specialty in alphabetical order.
1142	(31)  The agency shall establish an enhanced managed care
1143	quality assurance oversight function, to include at least the
1144	following components:
1145	(a)  At least quarterly analysis and followup, including
1146	sanctions as appropriate, of managed care participant
1147	utilization of services.
1148	(b)  At least quarterly analysis and followup, including
1149	sanctions as appropriate, of quality findings of the Medicaid
1150	peer review organization and other external quality assurance
1151	programs.
1152	(c)  At least quarterly analysis and followup, including
1153	sanctions as appropriate, of the fiscal viability of managed
1154	care plans.
1155	(d)  At least quarterly analysis and followup, including
1156	sanctions as appropriate, of managed care participant
1157	satisfaction and disenrollment surveys.
1158	(e)  The agency shall conduct regular and ongoing Medicaid
1159	recipient satisfaction surveys.
1160
1161	The analyses and followup activities conducted by the agency
1162	under its enhanced managed care quality assurance oversight
1163	function shall not duplicate the activities of accreditation
1164	reviewers for entities regulated under part III of chapter 641,
1165	but may include a review of the finding of such reviewers.
1166	(32)  Each managed care plan that is under contract with
1167	the agency to provide health care services to Medicaid
1168	recipients shall annually conduct a background check with the
1169	Florida Department of Law Enforcement of all persons with
1170	ownership interest of 5 percent or more or executive management
1171	responsibility for the managed care plan and shall submit to the
1172	agency information concerning any such person who has been found
1173	guilty of, regardless of adjudication, or has entered a plea of
1174	nolo contendere or guilty to, any of the offenses listed in s.
1175	435.03.
1176	(33)  The agency shall, by rule, develop a process whereby
1177	a Medicaid managed care plan enrollee who wishes to enter
1178	hospice care may be disenrolled from the managed care plan
1179	within 24 hours after contacting the agency regarding such
1180	request. The agency rule shall include a methodology for the
1181	agency to recoup managed care plan payments on a pro rata basis
1182	if payment has been made for the enrollment month when
1183	disenrollment occurs.
1184	(34)  The agency and entities that contract with the agency
1185	to provide health care services to Medicaid recipients under
1186	this section or ss. 409.91211 and 409.9122 must comply with the
1187	provisions of s. 641.513 in providing emergency services and
1188	care to Medicaid recipients and MediPass recipients. Where
1189	feasible, safe, and cost-effective, the agency shall encourage
1190	hospitals, emergency medical services providers, and other
1191	public and private health care providers to work together in
1192	their local communities to enter into agreements or arrangements
1193	to ensure access to alternatives to emergency services and care
1194	for those Medicaid recipients who need nonemergent care. The
1195	agency shall coordinate with hospitals, emergency medical
1196	services providers, private health plans, capitated managed care
1197	networks as established in s. 409.91211, and other public and
1198	private health care providers to implement the provisions of ss.
1199	395.1041(7), 409.91255(3)(g), 627.6405, and 641.31097 to develop
1200	and implement emergency department diversion programs for
1201	Medicaid recipients.
1202	(35)  All entities providing health care services to
1203	Medicaid recipients shall make available, and encourage all
1204	pregnant women and mothers with infants to receive, and provide
1205	documentation in the medical records to reflect, the following:
1206	(a)  Healthy Start prenatal or infant screening.
1207	(b)  Healthy Start care coordination, when screening or
1208	other factors indicate need.
1209	(c)  Healthy Start enhanced services in accordance with the
1210	prenatal or infant screening results.
1211	(d)  Immunizations in accordance with recommendations of
1212	the Advisory Committee on Immunization Practices of the United
1213	States Public Health Service and the American Academy of
1214	Pediatrics, as appropriate.
1215	(e)  Counseling and services for family planning to all
1216	women and their partners.
1217	(f)  A scheduled postpartum visit for the purpose of
1218	voluntary family planning, to include discussion of all methods
1219	of contraception, as appropriate.
1220	(g)  Referral to the Special Supplemental Nutrition Program
1221	for Women, Infants, and Children (WIC).
1222	(36)  Any entity that provides Medicaid prepaid health plan
1223	services shall ensure the appropriate coordination of health
1224	care services with an assisted living facility in cases where a
1225	Medicaid recipient is both a member of the entity's prepaid
1226	health plan and a resident of the assisted living facility. If
1227	the entity is at risk for Medicaid targeted case management and
1228	behavioral health services, the entity shall inform the assisted
1229	living facility of the procedures to follow should an emergent
1230	condition arise.
1231	(37)  The agency may seek and implement federal waivers
1232	necessary to provide for cost-effective purchasing of home
1233	health services, private duty nursing services, transportation,
1234	independent laboratory services, and durable medical equipment
1235	and supplies through competitive bidding pursuant to s. 287.057.
1236	The agency may request appropriate waivers from the federal
1237	Health Care Financing Administration in order to competitively
1238	bid such services. The agency may exclude providers not selected
1239	through the bidding process from the Medicaid provider network.
1240	(38)  The agency shall enter into agreements with not-for-
1241	profit organizations based in this state for the purpose of
1242	providing vision screening.
1243	(39)(a)  The agency shall implement a Medicaid prescribed-
1244	drug spending-control program that includes the following
1245	components:
1246	1.  A Medicaid preferred drug list, which shall be a
1247	listing of cost-effective therapeutic options recommended by the
1248	Adult Medicaid Pharmaceutical Pharmacy and Therapeutics
1249	Committee and the Pediatric Medicaid Pharmaceutical and
1250	Therapeutics Committee established pursuant to s. 409.91195 and
1251	adopted by the agency for each therapeutic class on the
1252	preferred drug list. At the discretion of the committees
1253	committee, and when feasible, the preferred drug list should
1254	include at least two products in a therapeutic class. The agency
1255	may post the preferred drug list and updates to the preferred
1256	drug list on an Internet website without following the
1257	rulemaking procedures of chapter 120. Antiretroviral agents are
1258	excluded from the preferred drug list. The agency shall also
1259	limit the amount of a prescribed drug dispensed to no more than
1260	a 34-day supply unless the drug products' smallest marketed
1261	package is greater than a 34-day supply, or the drug is
1262	determined by the agency to be a maintenance drug in which case
1263	a 100-day maximum supply may be authorized. The agency is
1264	authorized to seek any federal waivers necessary to implement
1265	these cost-control programs and to continue participation in the
1266	federal Medicaid rebate program, or alternatively to negotiate
1267	state-only manufacturer rebates. The agency may adopt rules to
1268	implement this subparagraph. The agency shall continue to
1269	provide unlimited contraceptive drugs and items. The agency must
1270	establish procedures to ensure that:
1271	a.  There will be a response to a request for prior
1272	consultation by telephone or other telecommunication device
1273	within 24 hours after receipt of a request for prior
1274	consultation; and
1275	b.  A 72-hour supply of the drug prescribed will be
1276	provided in an emergency or when the agency does not provide a
1277	response within 24 hours as required by sub-subparagraph a.
1278	2.  Reimbursement to pharmacies for Medicaid prescribed
1279	drugs shall be set at the lesser of: the average wholesale price
1280	(AWP) minus 15.4 percent, the wholesaler acquisition cost (WAC)
1281	plus 5.75 percent, the federal upper limit (FUL), the state
1282	maximum allowable cost (SMAC), or the usual and customary (UAC)
1283	charge billed by the provider.
1284	3.  The agency shall develop and implement a process for
1285	managing the drug therapies of Medicaid recipients who are using
1286	significant numbers of prescribed drugs each month. The
1287	management process may include, but is not limited to,
1288	comprehensive, physician-directed medical-record reviews, claims
1289	analyses, and case evaluations to determine the medical
1290	necessity and appropriateness of a patient's treatment plan and
1291	drug therapies. The agency may contract with a private
1292	organization to provide drug-program-management services. The
1293	Medicaid drug benefit management program shall include
1294	initiatives to manage drug therapies for HIV/AIDS patients,
1295	patients using 20 or more unique prescriptions in a 180-day
1296	period, and the top 1,000 patients in annual spending. The
1297	agency shall enroll any Medicaid recipient in the drug benefit
1298	management program if he or she meets the specifications of this
1299	provision and is not enrolled in a Medicaid health maintenance
1300	organization.
1301	4.  The agency may limit the size of its pharmacy network
1302	based on need, competitive bidding, price negotiations,
1303	credentialing, or similar criteria. The agency shall give
1304	special consideration to rural areas in determining the size and
1305	location of pharmacies included in the Medicaid pharmacy
1306	network. A pharmacy credentialing process may include criteria
1307	such as a pharmacy's full-service status, location, size,
1308	patient educational programs, patient consultation, disease
1309	management services, and other characteristics. The agency may
1310	impose a moratorium on Medicaid pharmacy enrollment when it is
1311	determined that it has a sufficient number of Medicaid-
1312	participating providers. The agency must allow dispensing
1313	practitioners to participate as a part of the Medicaid pharmacy
1314	network regardless of the practitioner's proximity to any other
1315	entity that is dispensing prescription drugs under the Medicaid
1316	program. A dispensing practitioner must meet all credentialing
1317	requirements applicable to his or her practice, as determined by
1318	the agency.
1319	5.  The agency shall develop and implement a program that
1320	requires Medicaid practitioners who prescribe drugs to use a
1321	counterfeit-proof prescription pad for Medicaid prescriptions.
1322	The agency shall require the use of standardized counterfeit-
1323	proof prescription pads by Medicaid-participating prescribers or
1324	prescribers who write prescriptions for Medicaid recipients. The
1325	agency may implement the program in targeted geographic areas or
1326	statewide.
1327	6.  The agency may enter into arrangements that require
1328	manufacturers of generic drugs prescribed to Medicaid recipients
1329	to provide rebates of at least 15.1 percent of the average
1330	manufacturer price for the manufacturer's generic products.
1331	These arrangements shall require that if a generic-drug
1332	manufacturer pays federal rebates for Medicaid-reimbursed drugs
1333	at a level below 15.1 percent, the manufacturer must provide a
1334	supplemental rebate to the state in an amount necessary to
1335	achieve a 15.1-percent rebate level.
1336	7.  The agency may establish a preferred drug list as
1337	described in this subsection, and, pursuant to the establishment
1338	of such preferred drug list, it is authorized to negotiate
1339	supplemental rebates from manufacturers that are in addition to
1340	those required by Title XIX of the Social Security Act and at no
1341	less than 14 percent of the average manufacturer price as
1342	defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
1343	the federal or supplemental rebate, or both, equals or exceeds
1344	29 percent. There is no upper limit on the supplemental rebates
1345	the agency may negotiate. The agency may determine that specific
1346	products, brand-name or generic, are competitive at lower rebate
1347	percentages. Agreement to pay the minimum supplemental rebate
1348	percentage will guarantee a manufacturer that the Adult Medicaid
1349	Pharmaceutical and Therapeutics Committee or the Pediatric
1350	Medicaid Pharmaceutical and Therapeutics Committee will consider
1351	a product for inclusion on the preferred drug list. However, a
1352	pharmaceutical manufacturer is not guaranteed placement on the
1353	preferred drug list by simply paying the minimum supplemental
1354	rebate. Agency decisions will be made on the clinical efficacy
1355	of a drug and recommendations of the Adult Medicaid
1356	Pharmaceutical and Therapeutics Committee and the Pediatric
1357	Medicaid Pharmaceutical and Therapeutics Committee, as well as
1358	the price of competing products minus federal and state rebates.
1359	The agency is authorized to contract with an outside agency or
1360	contractor to conduct negotiations for supplemental rebates. For
1361	the purposes of this section, the term "supplemental rebates"
1362	means cash rebates. Effective July 1, 2004, value-added programs
1363	as a substitution for supplemental rebates are prohibited. The
1364	agency is authorized to seek any federal waivers to implement
1365	this initiative.
1366	8.  The Agency for Health Care Administration shall expand
1367	home delivery of pharmacy products. To assist Medicaid patients
1368	in securing their prescriptions and reduce program costs, the
1369	agency shall expand its current mail-order-pharmacy diabetes-
1370	supply program to include all generic and brand-name drugs used
1371	by Medicaid patients with diabetes. Medicaid recipients in the
1372	current program may obtain nondiabetes drugs on a voluntary
1373	basis. This initiative is limited to the geographic area covered
1374	by the current contract. The agency may seek and implement any
1375	federal waivers necessary to implement this subparagraph.
1376	9.  The agency shall limit to one dose per month any drug
1377	prescribed to treat erectile dysfunction.
1378	10.a.  The agency may implement a Medicaid behavioral drug
1379	management system. The agency may contract with a vendor that
1380	has experience in operating behavioral drug management systems
1381	to implement this program. The agency is authorized to seek
1382	federal waivers to implement this program.
1383	b.  The agency, in conjunction with the Department of
1384	Children and Family Services, may implement the Medicaid
1385	behavioral drug management system that is designed to improve
1386	the quality of care and behavioral health prescribing practices
1387	based on best practice guidelines, improve patient adherence to
1388	medication plans, reduce clinical risk, and lower prescribed
1389	drug costs and the rate of inappropriate spending on Medicaid
1390	behavioral drugs. The program may include the following
1391	elements:
1392	(I)  Provide for the development and adoption of best
1393	practice guidelines for behavioral health-related drugs such as
1394	antipsychotics, antidepressants, and medications for treating
1395	bipolar disorders and other behavioral conditions; translate
1396	them into practice; review behavioral health prescribers and
1397	compare their prescribing patterns to a number of indicators
1398	that are based on national standards; and determine deviations
1399	from best practice guidelines.
1400	(II)  Implement processes for providing feedback to and
1401	educating prescribers using best practice educational materials
1402	and peer-to-peer consultation.
1403	(III)  Assess Medicaid beneficiaries who are outliers in
1404	their use of behavioral health drugs with regard to the numbers
1405	and types of drugs taken, drug dosages, combination drug
1406	therapies, and other indicators of improper use of behavioral
1407	health drugs.
1408	(IV)  Alert prescribers to patients who fail to refill
1409	prescriptions in a timely fashion, are prescribed multiple same-
1410	class behavioral health drugs, and may have other potential
1411	medication problems.
1412	(V)  Track spending trends for behavioral health drugs and
1413	deviation from best practice guidelines.
1414	(VI)  Use educational and technological approaches to
1415	promote best practices, educate consumers, and train prescribers
1416	in the use of practice guidelines.
1417	(VII)  Disseminate electronic and published materials.
1418	(VIII)  Hold statewide and regional conferences.
1419	(IX)  Implement a disease management program with a model
1420	quality-based medication component for severely mentally ill
1421	individuals and emotionally disturbed children who are high
1422	users of care.
1423	11.a.  The agency shall implement a Medicaid prescription
1424	drug management system. The agency may contract with a vendor
1425	that has experience in operating prescription drug management
1426	systems in order to implement this system. Any management system
1427	that is implemented in accordance with this subparagraph must
1428	rely on cooperation between physicians and pharmacists to
1429	determine appropriate practice patterns and clinical guidelines
1430	to improve the prescribing, dispensing, and use of drugs in the
1431	Medicaid program. The agency may seek federal waivers to
1432	implement this program.
1433	b.  The drug management system must be designed to improve
1434	the quality of care and prescribing practices based on best
1435	practice guidelines, improve patient adherence to medication
1436	plans, reduce clinical risk, and lower prescribed drug costs and
1437	the rate of inappropriate spending on Medicaid prescription
1438	drugs. The program must:
1439	(I)  Provide for the development and adoption of best
1440	practice guidelines for the prescribing and use of drugs in the
1441	Medicaid program, including translating best practice guidelines
1442	into practice; reviewing prescriber patterns and comparing them
1443	to indicators that are based on national standards and practice
1444	patterns of clinical peers in their community, statewide, and
1445	nationally; and determine deviations from best practice
1446	guidelines.
1447	(II)  Implement processes for providing feedback to and
1448	educating prescribers using best practice educational materials
1449	and peer-to-peer consultation.
1450	(III)  Assess Medicaid recipients who are outliers in their
1451	use of a single or multiple prescription drugs with regard to
1452	the numbers and types of drugs taken, drug dosages, combination
1453	drug therapies, and other indicators of improper use of
1454	prescription drugs.
1455	(IV)  Alert prescribers to patients who fail to refill
1456	prescriptions in a timely fashion, are prescribed multiple drugs
1457	that may be redundant or contraindicated, or may have other
1458	potential medication problems.
1459	(V)  Track spending trends for prescription drugs and
1460	deviation from best practice guidelines.
1461	(VI)  Use educational and technological approaches to
1462	promote best practices, educate consumers, and train prescribers
1463	in the use of practice guidelines.
1464	(VII)  Disseminate electronic and published materials.
1465	(VIII)  Hold statewide and regional conferences.
1466	(IX)  Implement disease management programs in cooperation
1467	with physicians and pharmacists, along with a model quality-
1468	based medication component for individuals having chronic
1469	medical conditions.
1470	12.  The agency is authorized to contract for drug rebate
1471	administration, including, but not limited to, calculating
1472	rebate amounts, invoicing manufacturers, negotiating disputes
1473	with manufacturers, and maintaining a database of rebate
1474	collections.
1475	13.  The agency may specify the preferred daily dosing form
1476	or strength for the purpose of promoting best practices with
1477	regard to the prescribing of certain drugs as specified in the
1478	General Appropriations Act and ensuring cost-effective
1479	prescribing practices.
1480	14.  The agency may require prior authorization for
1481	Medicaid-covered prescribed drugs. The agency may, but is not
1482	required to, prior-authorize the use of a product:
1483	a.  For an indication not approved in labeling;
1484	b.  To comply with certain clinical guidelines; or
1485	c.  If the product has the potential for overuse, misuse,
1486	or abuse.
1487
1488	The agency may require the prescribing professional to provide
1489	information about the rationale and supporting medical evidence
1490	for the use of a drug. The agency may post prior authorization
1491	criteria and protocol and updates to the list of drugs that are
1492	subject to prior authorization on an Internet website without
1493	amending its rule or engaging in additional rulemaking.
1494	15.  The agency, in conjunction with the committees
1495	Pharmaceutical and Therapeutics Committee, may require age-
1496	related prior authorizations for certain prescribed drugs. The
1497	agency may preauthorize the use of a drug for a recipient who
1498	may not meet the age requirement or may exceed the length of
1499	therapy for use of this product as recommended by the
1500	manufacturer and approved by the Food and Drug Administration.
1501	Prior authorization may require the prescribing professional to
1502	provide information about the rationale and supporting medical
1503	evidence for the use of a drug.
1504	16.  The agency shall implement a step-therapy prior
1505	authorization approval process for medications excluded from the
1506	preferred drug list. Medications listed on the preferred drug
1507	list must be used within the previous 12 months prior to the
1508	alternative medications that are not listed. The step-therapy
1509	prior authorization may require the prescriber to use the
1510	medications of a similar drug class or for a similar medical
1511	indication unless contraindicated in the Food and Drug
1512	Administration labeling. The trial period between the specified
1513	steps may vary according to the medical indication. The step-
1514	therapy approval process shall be developed in accordance with
1515	the committees committee as stated in s. 409.91195(7) and (8). A
1516	drug product may be approved without meeting the step-therapy
1517	prior authorization criteria if the prescribing physician
1518	provides the agency with additional written medical or clinical
1519	documentation that the product is medically necessary because:
1520	a.  There is not a drug on the preferred drug list to treat
1521	the disease or medical condition which is an acceptable clinical
1522	alternative;
1523	b.  The alternatives have been ineffective in the treatment
1524	of the beneficiary's disease; or
1525	c.  Based on historic evidence and known characteristics of
1526	the patient and the drug, the drug is likely to be ineffective,
1527	or the number of doses have been ineffective.
1528
1529	The agency shall work with the physician to determine the best
1530	alternative for the patient. The agency may adopt rules waiving
1531	the requirements for written clinical documentation for specific
1532	drugs in limited clinical situations.
1533	17.  The agency shall implement a return and reuse program
1534	for drugs dispensed by pharmacies to institutional recipients,
1535	which includes payment of a $5 restocking fee for the
1536	implementation and operation of the program. The return and
1537	reuse program shall be implemented electronically and in a
1538	manner that promotes efficiency. The program must permit a
1539	pharmacy to exclude drugs from the program if it is not
1540	practical or cost-effective for the drug to be included and must
1541	provide for the return to inventory of drugs that cannot be
1542	credited or returned in a cost-effective manner. The agency
1543	shall determine if the program has reduced the amount of
1544	Medicaid prescription drugs which are destroyed on an annual
1545	basis and if there are additional ways to ensure more
1546	prescription drugs are not destroyed which could safely be
1547	reused. The agency's conclusion and recommendations shall be
1548	reported to the Legislature by December 1, 2005.
1549	(40)  Notwithstanding the provisions of chapter 287, the
1550	agency may, at its discretion, renew a contract or contracts for
1551	fiscal intermediary services one or more times for such periods
1552	as the agency may decide; however, all such renewals may not
1553	combine to exceed a total period longer than the term of the
1554	original contract.
1555	(41)  The agency shall provide for the development of a
1556	demonstration project by establishment in Miami-Dade County of a
1557	long-term-care facility licensed pursuant to chapter 395 to
1558	improve access to health care for a predominantly minority,
1559	medically underserved, and medically complex population and to
1560	evaluate alternatives to nursing home care and general acute
1561	care for such population. Such project is to be located in a
1562	health care condominium and colocated with licensed facilities
1563	providing a continuum of care. The establishment of this project
1564	is not subject to the provisions of s. 408.036 or s. 408.039.
1565	(42)  The agency shall develop and implement a utilization
1566	management program for Medicaid-eligible recipients for the
1567	management of occupational, physical, respiratory, and speech
1568	therapies. The agency shall establish a utilization program that
1569	may require prior authorization in order to ensure medically
1570	necessary and cost-effective treatments. The program shall be
1571	operated in accordance with a federally approved waiver program
1572	or state plan amendment. The agency may seek a federal waiver or
1573	state plan amendment to implement this program. The agency may
1574	also competitively procure these services from an outside vendor
1575	on a regional or statewide basis.
1576	(43)  The agency may contract on a prepaid or fixed-sum
1577	basis with appropriately licensed prepaid dental health plans to
1578	provide dental services.
1579	(44)  The Agency for Health Care Administration shall
1580	ensure that any Medicaid managed care plan as defined in s.
1581	409.9122(2)(f), whether paid on a capitated basis or a shared
1582	savings basis, is cost-effective. For purposes of this
1583	subsection, the term "cost-effective" means that a network's
1584	per-member, per-month costs to the state, including, but not
1585	limited to, fee-for-service costs, administrative costs, and
1586	case-management fees, if any, must be no greater than the
1587	state's costs associated with contracts for Medicaid services
1588	established under subsection (3), which may be adjusted for
1589	health status. The agency shall conduct actuarially sound
1590	adjustments for health status in order to ensure such cost-
1591	effectiveness and shall publish the results on its Internet
1592	website and submit the results annually to the Governor, the
1593	President of the Senate, and the Speaker of the House of
1594	Representatives no later than December 31 of each year.
1595	Contracts established pursuant to this subsection which are not
1596	cost-effective may not be renewed.
1597	(45)  Subject to the availability of funds, the agency
1598	shall mandate a recipient's participation in a provider lock-in
1599	program, when appropriate, if a recipient is found by the agency
1600	to have used Medicaid goods or services at a frequency or amount
1601	not medically necessary, limiting the receipt of goods or
1602	services to medically necessary providers after the 21-day
1603	appeal process has ended, for a period of not less than 1 year.
1604	The lock-in programs shall include, but are not limited to,
1605	pharmacies, medical doctors, and infusion clinics. The
1606	limitation does not apply to emergency services and care
1607	provided to the recipient in a hospital emergency department.
1608	The agency shall seek any federal waivers necessary to implement
1609	this subsection. The agency shall adopt any rules necessary to
1610	comply with or administer this subsection.
1611	(46)  The agency shall seek a federal waiver for permission
1612	to terminate the eligibility of a Medicaid recipient who has
1613	been found to have committed fraud, through judicial or
1614	administrative determination, two times in a period of 5 years.
1615	(47)  The agency shall conduct a study of available
1616	electronic systems for the purpose of verifying the identity and
1617	eligibility of a Medicaid recipient. The agency shall recommend
1618	to the Legislature a plan to implement an electronic
1619	verification system for Medicaid recipients by January 31, 2005.
1620	(48)  A provider is not entitled to enrollment in the
1621	Medicaid provider network. The agency may implement a Medicaid
1622	fee-for-service provider network controls, including, but not
1623	limited to, competitive procurement and provider credentialing.
1624	If a credentialing process is used, the agency may limit its
1625	provider network based upon the following considerations:
1626	beneficiary access to care, provider availability, provider
1627	quality standards and quality assurance processes, cultural
1628	competency, demographic characteristics of beneficiaries,
1629	practice standards, service wait times, provider turnover,
1630	provider licensure and accreditation history, program integrity
1631	history, peer review, Medicaid policy and billing compliance
1632	records, clinical and medical record audit findings, and such
1633	other areas that are considered necessary by the agency to
1634	ensure the integrity of the program.
1635	(49)  The agency shall contract with established minority
1636	physician networks that provide services to historically
1637	underserved minority patients. The networks must provide cost-
1638	effective Medicaid services, comply with the requirements to be
1639	a MediPass provider, and provide their primary care physicians
1640	with access to data and other management tools necessary to
1641	assist them in ensuring the appropriate use of services,
1642	including inpatient hospital services and pharmaceuticals.
1643	(a)  The agency shall provide for the development and
1644	expansion of minority physician networks in each service area to
1645	provide services to Medicaid recipients who are eligible to
1646	participate under federal law and rules.
1647	(b)  The agency shall reimburse each minority physician
1648	network as a fee-for-service provider, including the case
1649	management fee for primary care, if any, or as a capitated rate
1650	provider for Medicaid services. Any savings shall be shared with
1651	the minority physician networks pursuant to the contract.
1652	(c)  For purposes of this subsection, the term "cost-
1653	effective" means that a network's per-member, per-month costs to
1654	the state, including, but not limited to, fee-for-service costs,
1655	administrative costs, and case-management fees, if any, must be
1656	no greater than the state's costs associated with contracts for
1657	Medicaid services established under subsection (3), which shall
1658	be actuarially adjusted for case mix, model, and service area.
1659	The agency shall conduct actuarially sound audits adjusted for
1660	case mix and model in order to ensure such cost-effectiveness
1661	and shall publish the audit results on its Internet website and
1662	submit the audit results annually to the Governor, the President
1663	of the Senate, and the Speaker of the House of Representatives
1664	no later than December 31. Contracts established pursuant to
1665	this subsection which are not cost-effective may not be renewed.
1666	(d)  The agency may apply for any federal waivers needed to
1667	implement this subsection.
1668	(50)  To the extent permitted by federal law and as allowed
1669	under s. 409.906, the agency shall provide reimbursement for
1670	emergency mental health care services for Medicaid recipients in
1671	crisis stabilization facilities licensed under s. 394.875 as
1672	long as those services are less expensive than the same services
1673	provided in a hospital setting.
1674	(51)  The agency shall work with the Agency for Persons
1675	with Disabilities to develop a home and community-based waiver
1676	to serve children and adults who are diagnosed with familial
1677	dysautonomia or Riley-Day syndrome caused by a mutation of the
1678	IKBKAP gene on chromosome 9. The agency shall seek federal
1679	waiver approval and implement the approved waiver subject to the
1680	availability of funds and any limitations provided in the
1681	General Appropriations Act. The agency may adopt rules to
1682	implement this waiver program.
1683	(52)  The agency shall implement a program of all-inclusive
1684	care for children. The program of all-inclusive care for
1685	children shall be established to provide in-home hospice-like
1686	support services to children diagnosed with a life-threatening
1687	illness and enrolled in the Children's Medical Services network
1688	to reduce hospitalizations as appropriate. The agency, in
1689	consultation with the Department of Health, may implement the
1690	program of all-inclusive care for children after obtaining
1691	approval from the Centers for Medicare and Medicaid Services.
1692	Section 4.  This act shall take effect July 1, 2007.

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