Amendment
Bill No. 6003

Amendment No. 126277

CHAMBER ACTION
Senate		House
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1	The Rules & Calendar Council offered the following:
2
3	Technical Amendment
4	Remove line(s) 2194-2262 and insert:
5	(34)(35)  All entities providing health care services to
6	Medicaid recipients shall make available, and encourage all
7	pregnant women and mothers with infants to receive, and provide
8	documentation in the medical records to reflect, the following:
9	(a)  Healthy Start prenatal or infant screening.
10	(b)  Healthy Start care coordination, when screening or
11	other factors indicate need.
12	(c)  Healthy Start enhanced services in accordance with the
13	prenatal or infant screening results.
14	(d)  Immunizations in accordance with recommendations of
15	the Advisory Committee on Immunization Practices of the United
16	States Public Health Service and the American Academy of
17	Pediatrics, as appropriate.
18	(e)  Counseling and services for family planning to all
19	women and their partners.
20	(f)  A scheduled postpartum visit for the purpose of
21	voluntary family planning, to include discussion of all methods
22	of contraception, as appropriate.
23	(g)  Referral to the Special Supplemental Nutrition Program
24	for Women, Infants, and Children (WIC).
25	(35)(36)  Any entity that provides Medicaid prepaid health
26	plan services shall ensure the appropriate coordination of
27	health care services with an assisted living facility in cases
28	where a Medicaid recipient is both a member of the entity's
29	prepaid health plan and a resident of the assisted living
30	facility. If the entity is at risk for Medicaid targeted case
31	management and behavioral health services, the entity shall
32	inform the assisted living facility of the procedures to follow
33	should an emergent condition arise.
34	(36)(37)  The agency may seek and implement federal waivers
35	necessary to provide for cost-effective purchasing of home
36	health services, private duty nursing services, transportation,
37	independent laboratory services, and durable medical equipment
38	and supplies through competitive bidding pursuant to s. 287.057.
39	The agency may request appropriate waivers from the federal
40	Health Care Financing Administration in order to competitively
41	bid such services. The agency may exclude providers not selected
42	through the bidding process from the Medicaid provider network.
43	(37)(38)  The agency shall enter into agreements with not-
44	for-profit organizations based in this state for the purpose of
45	providing vision screening.
46	(38)(39)(a)  The agency shall implement a Medicaid
47	prescribed-drug spending-control program that includes the
48	following components:
49	1.  Medicaid prescribed-drug coverage for brand-name drugs
50	for adult Medicaid recipients is limited to the dispensing of
51	four brand-name drugs per month per recipient. Children are
52	exempt from this restriction. Antiretroviral agents are excluded
53	from this limitation. No requirements for prior authorization or
54	other restrictions on medications used to treat mental illnesses
55	such as schizophrenia, severe depression, or bipolar disorder
56	may be imposed on Medicaid recipients. Medications that will be
57	available without restriction for persons with mental illnesses
58	include atypical antipsychotic medications, conventional
59	antipsychotic medications, selective serotonin reuptake
60	inhibitors, and other medications used for the treatment of
61	serious mental illnesses. The agency shall also limit the amount
62	of a prescribed drug dispensed to no more than a 34-day supply.
63	The agency shall continue to provide unlimited generic drugs,
64	contraceptive drugs and items, and diabetic supplies. Although a
65	drug may be included on the preferred drug formulary, it would
66	not be exempt from the four-brand limit. The agency may
67	authorize exceptions to the brand-name-drug restriction based
68	upon the treatment needs of the patients, only when such
69	exceptions are based on prior consultation provided by the
70	agency or an agency contractor, but the agency must establish
71	procedures to ensure that:
72	a.  There will be a response to a request for prior
73	consultation by telephone or other telecommunication device
74	within 24 hours after receipt of a request for prior
75	consultation;
76	b.  A 72-hour supply of the drug prescribed will be
77	provided in an emergency or when the agency does not provide a
78	response within 24 hours as required by sub-subparagraph a.; and
79	c.  Except for the exception for nursing home residents and
80	other institutionalized adults and except for drugs on the
81	restricted formulary for which prior authorization may be sought
82	by an institutional or community pharmacy, prior authorization
83	for an exception to the brand-name-drug restriction is sought by
84	the prescriber and not by the pharmacy. When prior authorization
85	is granted for a patient in an institutional setting beyond the
86	brand-name-drug restriction, such approval is authorized for 12
87	months and monthly prior authorization is not required for that
88	patient.
89	2.  Reimbursement to pharmacies for Medicaid prescribed
90	drugs shall be set at the lesser of: the average wholesale price
91	(AWP) minus 15.4 percent, the wholesaler acquisition cost (WAC)
92	plus 5.75 percent, the federal upper limit (FUL), the state
93	maximum allowable cost (SMAC), or the usual and customary (UAC)
94	charge billed by the provider.
95	3.  The agency shall develop and implement a process for
96	managing the drug therapies of Medicaid recipients who are using
97	significant numbers of prescribed drugs each month. The
98	management process may include, but is not limited to,
99	comprehensive, physician-directed medical-record reviews, claims
100	analyses, and case evaluations to determine the medical
101	necessity and appropriateness of a patient's treatment plan and
102	drug therapies. The agency may contract with a private
103	organization to provide drug-program-management services. The
104	Medicaid drug benefit management program shall include
105	initiatives to manage drug therapies for HIV/AIDS patients,
106	patients using 20 or more unique prescriptions in a 180-day
107	period, and the top 1,000 patients in annual spending. The
108	agency shall enroll any Medicaid recipient in the drug benefit
109	management program if he or she meets the specifications of this
110	provision and is not enrolled in a Medicaid health maintenance
111	organization.
112	4.  The agency may limit the size of its pharmacy network
113	based on need, competitive bidding, price negotiations,
114	credentialing, or similar criteria. The agency shall give
115	special consideration to rural areas in determining the size and
116	location of pharmacies included in the Medicaid pharmacy
117	network. A pharmacy credentialing process may include criteria
118	such as a pharmacy's full-service status, location, size,
119	patient educational programs, patient consultation, disease-
120	management services, and other characteristics. The agency may
121	impose a moratorium on Medicaid pharmacy enrollment when it is
122	determined that it has a sufficient number of Medicaid-
123	participating providers.
124	5.  The agency shall develop and implement a program that
125	requires Medicaid practitioners who prescribe drugs to use a
126	counterfeit-proof prescription pad for Medicaid prescriptions.
127	The agency shall require the use of standardized counterfeit-
128	proof prescription pads by Medicaid-participating prescribers or
129	prescribers who write prescriptions for Medicaid recipients. The
130	agency may implement the program in targeted geographic areas or
131	statewide.
132	6.  The agency may enter into arrangements that require
133	manufacturers of generic drugs prescribed to Medicaid recipients
134	to provide rebates of at least 15.1 percent of the average
135	manufacturer price for the manufacturer's generic products.
136	These arrangements shall require that if a generic-drug
137	manufacturer pays federal rebates for Medicaid-reimbursed drugs
138	at a level below 15.1 percent, the manufacturer must provide a
139	supplemental rebate to the state in an amount necessary to
140	achieve a 15.1-percent rebate level.
141	7.  The agency may establish a preferred drug formulary in
142	accordance with 42 U.S.C. s. 1396r-8, and, pursuant to the
143	establishment of such formulary, it is authorized to negotiate
144	supplemental rebates from manufacturers that are in addition to
145	those required by Title XIX of the Social Security Act and at no
146	less than 14 percent of the average manufacturer price as
147	defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
148	the federal or supplemental rebate, or both, equals or exceeds
149	29 percent. There is no upper limit on the supplemental rebates
150	the agency may negotiate. The agency may determine that specific
151	products, brand-name or generic, are competitive at lower rebate
152	percentages. Agreement to pay the minimum supplemental rebate
153	percentage will guarantee a manufacturer that the Medicaid
154	Pharmaceutical and Therapeutics Committee will consider a
155	product for inclusion on the preferred drug formulary. However,
156	a pharmaceutical manufacturer is not guaranteed placement on the
157	formulary by simply paying the minimum supplemental rebate.
158	Agency decisions will be made on the clinical efficacy of a drug
159	and recommendations of the Medicaid Pharmaceutical and
160	Therapeutics Committee, as well as the price of competing
161	products minus federal and state rebates. The agency is
162	authorized to contract with an outside agency or contractor to
163	conduct negotiations for supplemental rebates. For the purposes
164	of this section, the term "supplemental rebates" means cash
165	rebates. Effective July 1, 2004, value-added programs as a
166	substitution for supplemental rebates are prohibited. The agency
167	is authorized to seek any federal waivers to implement this
168	initiative.
169	8.  The agency shall establish an advisory committee for
170	the purposes of studying the feasibility of using a restricted
171	drug formulary for nursing home residents and other
172	institutionalized adults. The committee shall be comprised of
173	seven members appointed by the Secretary of Health Care
174	Administration. The committee members shall include two
175	physicians licensed under chapter 458 or chapter 459; three
176	pharmacists licensed under chapter 465 and appointed from a list
177	of recommendations provided by the Florida Long-Term Care
178	Pharmacy Alliance; and two pharmacists licensed under chapter
179	465.
180	9.  The Agency for Health Care Administration shall expand
181	home delivery of pharmacy products. To assist Medicaid patients
182	in securing their prescriptions and reduce program costs, the
183	agency shall expand its current mail-order-pharmacy diabetes-
184	supply program to include all generic and brand-name drugs used
185	by Medicaid patients with diabetes. Medicaid recipients in the
186	current program may obtain nondiabetes drugs on a voluntary
187	basis. This initiative is limited to the geographic area covered
188	by the current contract. The agency may seek and implement any
189	federal waivers necessary to implement this subparagraph.
190	10.  The agency shall limit to one dose per month any drug
191	prescribed to treat erectile dysfunction.
192	11.a.  The agency shall implement a Medicaid behavioral
193	drug management system. The agency may contract with a vendor
194	that has experience in operating behavioral drug management
195	systems to implement this program. The agency is authorized to
196	seek federal waivers to implement this program.
197	b.  The agency, in conjunction with the Department of
198	Children and Family Services, may implement the Medicaid
199	behavioral drug management system that is designed to improve
200	the quality of care and behavioral health prescribing practices
201	based on best practice guidelines, improve patient adherence to
202	medication plans, reduce clinical risk, and lower prescribed
203	drug costs and the rate of inappropriate spending on Medicaid
204	behavioral drugs. The program shall include the following
205	elements:
206	(I)  Provide for the development and adoption of best
207	practice guidelines for behavioral health-related drugs such as
208	antipsychotics, antidepressants, and medications for treating
209	bipolar disorders and other behavioral conditions; translate
210	them into practice; review behavioral health prescribers and
211	compare their prescribing patterns to a number of indicators
212	that are based on national standards; and determine deviations
213	from best practice guidelines.
214	(II)  Implement processes for providing feedback to and
215	educating prescribers using best practice educational materials
216	and peer-to-peer consultation.
217	(III)  Assess Medicaid beneficiaries who are outliers in
218	their use of behavioral health drugs with regard to the numbers
219	and types of drugs taken, drug dosages, combination drug
220	therapies, and other indicators of improper use of behavioral
221	health drugs.
222	(IV)  Alert prescribers to patients who fail to refill
223	prescriptions in a timely fashion, are prescribed multiple same-
224	class behavioral health drugs, and may have other potential
225	medication problems.
226	(V)  Track spending trends for behavioral health drugs and
227	deviation from best practice guidelines.
228	(VI)  Use educational and technological approaches to
229	promote best practices, educate consumers, and train prescribers
230	in the use of practice guidelines.
231	(VII)  Disseminate electronic and published materials.
232	(VIII)  Hold statewide and regional conferences.
233	(IX)  Implement a disease management program with a model
234	quality-based medication component for severely mentally ill
235	individuals and emotionally disturbed children who are high
236	users of care.
237	c.  If the agency is unable to negotiate a contract with
238	one or more manufacturers to finance and guarantee savings
239	associated with a behavioral drug management program by
240	September 1, 2004, the four-brand drug limit and preferred drug
241	list prior-authorization requirements shall apply to mental
242	health-related drugs, notwithstanding any provision in
243	subparagraph 1. The agency is authorized to seek federal waivers
244	to implement this policy.
245	12.a.  The agency shall implement a Medicaid prescription-
246	drug-management system. The agency may contract with a vendor
247	that has experience in operating prescription-drug-management
248	systems in order to implement this system. Any management system
249	that is implemented in accordance with this subparagraph must
250	rely on cooperation between physicians and pharmacists to
251	determine appropriate practice patterns and clinical guidelines
252	to improve the prescribing, dispensing, and use of drugs in the
253	Medicaid program. The agency may seek federal waivers to
254	implement this program.
255	b.  The drug-management system must be designed to improve
256	the quality of care and prescribing practices based on best-
257	practice guidelines, improve patient adherence to medication
258	plans, reduce clinical risk, and lower prescribed drug costs and
259	the rate of inappropriate spending on Medicaid prescription
260	drugs. The program must:
261	(I)  Provide for the development and adoption of best-
262	practice guidelines for the prescribing and use of drugs in the
263	Medicaid program, including translating best-practice guidelines
264	into practice; reviewing prescriber patterns and comparing them
265	to indicators that are based on national standards and practice
266	patterns of clinical peers in their community, statewide, and
267	nationally; and determine deviations from best-practice
268	guidelines.
269	(II)  Implement processes for providing feedback to and
270	educating prescribers using best-practice educational materials
271	and peer-to-peer consultation.
272	(III)  Assess Medicaid recipients who are outliers in their
273	use of a single or multiple prescription drugs with regard to
274	the numbers and types of drugs taken, drug dosages, combination
275	drug therapies, and other indicators of improper use of
276	prescription drugs.
277	(IV)  Alert prescribers to patients who fail to refill
278	prescriptions in a timely fashion, are prescribed multiple drugs
279	that may be redundant or contraindicated, or may have other
280	potential medication problems.
281	(V)  Track spending trends for prescription drugs and
282	deviation from best practice guidelines.
283	(VI)  Use educational and technological approaches to
284	promote best practices, educate consumers, and train prescribers
285	in the use of practice guidelines.
286	(VII)  Disseminate electronic and published materials.
287	(VIII)  Hold statewide and regional conferences.
288	(IX)  Implement disease-management programs in cooperation
289	with physicians and pharmacists, along with a model quality-
290	based medication component for individuals having chronic
291	medical conditions.
292	13.12.  The agency is authorized to contract for drug
293	rebate administration, including, but not limited to,
294	calculating rebate amounts, invoicing manufacturers, negotiating
295	disputes with manufacturers, and maintaining a database of
296	rebate collections.
297	14.13.  The agency may specify the preferred daily dosing
298	form or strength for the purpose of promoting best practices
299	with regard to the prescribing of certain drugs as specified in
300	the General Appropriations Act and ensuring cost-effective
301	prescribing practices.
302	15.14.  The agency may require prior authorization for the
303	off-label use of Medicaid-covered prescribed drugs as specified
304	in the General Appropriations Act. The agency may, but is not
305	required to, preauthorize the use of a product for an indication
306	not in the approved labeling. Prior authorization may require
307	the prescribing professional to provide information about the
308	rationale and supporting medical evidence for the off-label use
309	of a drug.
310	16.15.  The agency shall implement a return and reuse

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