Amendment
Bill No. 6003
Amendment No. 126277
CHAMBER ACTION
Senate House
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1The 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
6Medicaid recipients shall make available, and encourage all
7pregnant women and mothers with infants to receive, and provide
8documentation 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
11other factors indicate need.
12     (c)  Healthy Start enhanced services in accordance with the
13prenatal or infant screening results.
14     (d)  Immunizations in accordance with recommendations of
15the Advisory Committee on Immunization Practices of the United
16States Public Health Service and the American Academy of
17Pediatrics, as appropriate.
18     (e)  Counseling and services for family planning to all
19women and their partners.
20     (f)  A scheduled postpartum visit for the purpose of
21voluntary family planning, to include discussion of all methods
22of contraception, as appropriate.
23     (g)  Referral to the Special Supplemental Nutrition Program
24for Women, Infants, and Children (WIC).
25     (35)(36)  Any entity that provides Medicaid prepaid health
26plan services shall ensure the appropriate coordination of
27health care services with an assisted living facility in cases
28where a Medicaid recipient is both a member of the entity's
29prepaid health plan and a resident of the assisted living
30facility. If the entity is at risk for Medicaid targeted case
31management and behavioral health services, the entity shall
32inform the assisted living facility of the procedures to follow
33should an emergent condition arise.
34     (36)(37)  The agency may seek and implement federal waivers
35necessary to provide for cost-effective purchasing of home
36health services, private duty nursing services, transportation,
37independent laboratory services, and durable medical equipment
38and supplies through competitive bidding pursuant to s. 287.057.
39The agency may request appropriate waivers from the federal
40Health Care Financing Administration in order to competitively
41bid such services. The agency may exclude providers not selected
42through the bidding process from the Medicaid provider network.
43     (37)(38)  The agency shall enter into agreements with not-
44for-profit organizations based in this state for the purpose of
45providing vision screening.
46     (38)(39)(a)  The agency shall implement a Medicaid
47prescribed-drug spending-control program that includes the
48following components:
49     1.  Medicaid prescribed-drug coverage for brand-name drugs
50for adult Medicaid recipients is limited to the dispensing of
51four brand-name drugs per month per recipient. Children are
52exempt from this restriction. Antiretroviral agents are excluded
53from this limitation. No requirements for prior authorization or
54other restrictions on medications used to treat mental illnesses
55such as schizophrenia, severe depression, or bipolar disorder
56may be imposed on Medicaid recipients. Medications that will be
57available without restriction for persons with mental illnesses
58include atypical antipsychotic medications, conventional
59antipsychotic medications, selective serotonin reuptake
60inhibitors, and other medications used for the treatment of
61serious mental illnesses. The agency shall also limit the amount
62of a prescribed drug dispensed to no more than a 34-day supply.
63The agency shall continue to provide unlimited generic drugs,
64contraceptive drugs and items, and diabetic supplies. Although a
65drug may be included on the preferred drug formulary, it would
66not be exempt from the four-brand limit. The agency may
67authorize exceptions to the brand-name-drug restriction based
68upon the treatment needs of the patients, only when such
69exceptions are based on prior consultation provided by the
70agency or an agency contractor, but the agency must establish
71procedures to ensure that:
72     a.  There will be a response to a request for prior
73consultation by telephone or other telecommunication device
74within 24 hours after receipt of a request for prior
75consultation;
76     b.  A 72-hour supply of the drug prescribed will be
77provided in an emergency or when the agency does not provide a
78response within 24 hours as required by sub-subparagraph a.; and
79     c.  Except for the exception for nursing home residents and
80other institutionalized adults and except for drugs on the
81restricted formulary for which prior authorization may be sought
82by an institutional or community pharmacy, prior authorization
83for an exception to the brand-name-drug restriction is sought by
84the prescriber and not by the pharmacy. When prior authorization
85is granted for a patient in an institutional setting beyond the
86brand-name-drug restriction, such approval is authorized for 12
87months and monthly prior authorization is not required for that
88patient.
89     2.  Reimbursement to pharmacies for Medicaid prescribed
90drugs shall be set at the lesser of: the average wholesale price
91(AWP) minus 15.4 percent, the wholesaler acquisition cost (WAC)
92plus 5.75 percent, the federal upper limit (FUL), the state
93maximum allowable cost (SMAC), or the usual and customary (UAC)
94charge billed by the provider.
95     3.  The agency shall develop and implement a process for
96managing the drug therapies of Medicaid recipients who are using
97significant numbers of prescribed drugs each month. The
98management process may include, but is not limited to,
99comprehensive, physician-directed medical-record reviews, claims
100analyses, and case evaluations to determine the medical
101necessity and appropriateness of a patient's treatment plan and
102drug therapies. The agency may contract with a private
103organization to provide drug-program-management services. The
104Medicaid drug benefit management program shall include
105initiatives to manage drug therapies for HIV/AIDS patients,
106patients using 20 or more unique prescriptions in a 180-day
107period, and the top 1,000 patients in annual spending. The
108agency shall enroll any Medicaid recipient in the drug benefit
109management program if he or she meets the specifications of this
110provision and is not enrolled in a Medicaid health maintenance
111organization.
112     4.  The agency may limit the size of its pharmacy network
113based on need, competitive bidding, price negotiations,
114credentialing, or similar criteria. The agency shall give
115special consideration to rural areas in determining the size and
116location of pharmacies included in the Medicaid pharmacy
117network. A pharmacy credentialing process may include criteria
118such as a pharmacy's full-service status, location, size,
119patient educational programs, patient consultation, disease-
120management services, and other characteristics. The agency may
121impose a moratorium on Medicaid pharmacy enrollment when it is
122determined that it has a sufficient number of Medicaid-
123participating providers.
124     5.  The agency shall develop and implement a program that
125requires Medicaid practitioners who prescribe drugs to use a
126counterfeit-proof prescription pad for Medicaid prescriptions.
127The agency shall require the use of standardized counterfeit-
128proof prescription pads by Medicaid-participating prescribers or
129prescribers who write prescriptions for Medicaid recipients. The
130agency may implement the program in targeted geographic areas or
131statewide.
132     6.  The agency may enter into arrangements that require
133manufacturers of generic drugs prescribed to Medicaid recipients
134to provide rebates of at least 15.1 percent of the average
135manufacturer price for the manufacturer's generic products.
136These arrangements shall require that if a generic-drug
137manufacturer pays federal rebates for Medicaid-reimbursed drugs
138at a level below 15.1 percent, the manufacturer must provide a
139supplemental rebate to the state in an amount necessary to
140achieve a 15.1-percent rebate level.
141     7.  The agency may establish a preferred drug formulary in
142accordance with 42 U.S.C. s. 1396r-8, and, pursuant to the
143establishment of such formulary, it is authorized to negotiate
144supplemental rebates from manufacturers that are in addition to
145those required by Title XIX of the Social Security Act and at no
146less than 14 percent of the average manufacturer price as
147defined in 42 U.S.C. s. 1936 on the last day of a quarter unless
148the federal or supplemental rebate, or both, equals or exceeds
14929 percent. There is no upper limit on the supplemental rebates
150the agency may negotiate. The agency may determine that specific
151products, brand-name or generic, are competitive at lower rebate
152percentages. Agreement to pay the minimum supplemental rebate
153percentage will guarantee a manufacturer that the Medicaid
154Pharmaceutical and Therapeutics Committee will consider a
155product for inclusion on the preferred drug formulary. However,
156a pharmaceutical manufacturer is not guaranteed placement on the
157formulary by simply paying the minimum supplemental rebate.
158Agency decisions will be made on the clinical efficacy of a drug
159and recommendations of the Medicaid Pharmaceutical and
160Therapeutics Committee, as well as the price of competing
161products minus federal and state rebates. The agency is
162authorized to contract with an outside agency or contractor to
163conduct negotiations for supplemental rebates. For the purposes
164of this section, the term "supplemental rebates" means cash
165rebates. Effective July 1, 2004, value-added programs as a
166substitution for supplemental rebates are prohibited. The agency
167is authorized to seek any federal waivers to implement this
168initiative.
169     8.  The agency shall establish an advisory committee for
170the purposes of studying the feasibility of using a restricted
171drug formulary for nursing home residents and other
172institutionalized adults. The committee shall be comprised of
173seven members appointed by the Secretary of Health Care
174Administration. The committee members shall include two
175physicians licensed under chapter 458 or chapter 459; three
176pharmacists licensed under chapter 465 and appointed from a list
177of recommendations provided by the Florida Long-Term Care
178Pharmacy Alliance; and two pharmacists licensed under chapter
179465.
180     9.  The Agency for Health Care Administration shall expand
181home delivery of pharmacy products. To assist Medicaid patients
182in securing their prescriptions and reduce program costs, the
183agency shall expand its current mail-order-pharmacy diabetes-
184supply program to include all generic and brand-name drugs used
185by Medicaid patients with diabetes. Medicaid recipients in the
186current program may obtain nondiabetes drugs on a voluntary
187basis. This initiative is limited to the geographic area covered
188by the current contract. The agency may seek and implement any
189federal waivers necessary to implement this subparagraph.
190     10.  The agency shall limit to one dose per month any drug
191prescribed to treat erectile dysfunction.
192     11.a.  The agency shall implement a Medicaid behavioral
193drug management system. The agency may contract with a vendor
194that has experience in operating behavioral drug management
195systems to implement this program. The agency is authorized to
196seek federal waivers to implement this program.
197     b.  The agency, in conjunction with the Department of
198Children and Family Services, may implement the Medicaid
199behavioral drug management system that is designed to improve
200the quality of care and behavioral health prescribing practices
201based on best practice guidelines, improve patient adherence to
202medication plans, reduce clinical risk, and lower prescribed
203drug costs and the rate of inappropriate spending on Medicaid
204behavioral drugs. The program shall include the following
205elements:
206     (I)  Provide for the development and adoption of best
207practice guidelines for behavioral health-related drugs such as
208antipsychotics, antidepressants, and medications for treating
209bipolar disorders and other behavioral conditions; translate
210them into practice; review behavioral health prescribers and
211compare their prescribing patterns to a number of indicators
212that are based on national standards; and determine deviations
213from best practice guidelines.
214     (II)  Implement processes for providing feedback to and
215educating prescribers using best practice educational materials
216and peer-to-peer consultation.
217     (III)  Assess Medicaid beneficiaries who are outliers in
218their use of behavioral health drugs with regard to the numbers
219and types of drugs taken, drug dosages, combination drug
220therapies, and other indicators of improper use of behavioral
221health drugs.
222     (IV)  Alert prescribers to patients who fail to refill
223prescriptions in a timely fashion, are prescribed multiple same-
224class behavioral health drugs, and may have other potential
225medication problems.
226     (V)  Track spending trends for behavioral health drugs and
227deviation from best practice guidelines.
228     (VI)  Use educational and technological approaches to
229promote best practices, educate consumers, and train prescribers
230in 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
234quality-based medication component for severely mentally ill
235individuals and emotionally disturbed children who are high
236users of care.
237     c.  If the agency is unable to negotiate a contract with
238one or more manufacturers to finance and guarantee savings
239associated with a behavioral drug management program by
240September 1, 2004, the four-brand drug limit and preferred drug
241list prior-authorization requirements shall apply to mental
242health-related drugs, notwithstanding any provision in
243subparagraph 1. The agency is authorized to seek federal waivers
244to implement this policy.
245     12.a.  The agency shall implement a Medicaid prescription-
246drug-management system. The agency may contract with a vendor
247that has experience in operating prescription-drug-management
248systems in order to implement this system. Any management system
249that is implemented in accordance with this subparagraph must
250rely on cooperation between physicians and pharmacists to
251determine appropriate practice patterns and clinical guidelines
252to improve the prescribing, dispensing, and use of drugs in the
253Medicaid program. The agency may seek federal waivers to
254implement this program.
255     b.  The drug-management system must be designed to improve
256the quality of care and prescribing practices based on best-
257practice guidelines, improve patient adherence to medication
258plans, reduce clinical risk, and lower prescribed drug costs and
259the rate of inappropriate spending on Medicaid prescription
260drugs. The program must:
261     (I)  Provide for the development and adoption of best-
262practice guidelines for the prescribing and use of drugs in the
263Medicaid program, including translating best-practice guidelines
264into practice; reviewing prescriber patterns and comparing them
265to indicators that are based on national standards and practice
266patterns of clinical peers in their community, statewide, and
267nationally; and determine deviations from best-practice
268guidelines.
269     (II)  Implement processes for providing feedback to and
270educating prescribers using best-practice educational materials
271and peer-to-peer consultation.
272     (III)  Assess Medicaid recipients who are outliers in their
273use of a single or multiple prescription drugs with regard to
274the numbers and types of drugs taken, drug dosages, combination
275drug therapies, and other indicators of improper use of
276prescription drugs.
277     (IV)  Alert prescribers to patients who fail to refill
278prescriptions in a timely fashion, are prescribed multiple drugs
279that may be redundant or contraindicated, or may have other
280potential medication problems.
281     (V)  Track spending trends for prescription drugs and
282deviation from best practice guidelines.
283     (VI)  Use educational and technological approaches to
284promote best practices, educate consumers, and train prescribers
285in 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
289with physicians and pharmacists, along with a model quality-
290based medication component for individuals having chronic
291medical conditions.
292     13.12.  The agency is authorized to contract for drug
293rebate administration, including, but not limited to,
294calculating rebate amounts, invoicing manufacturers, negotiating
295disputes with manufacturers, and maintaining a database of
296rebate collections.
297     14.13.  The agency may specify the preferred daily dosing
298form or strength for the purpose of promoting best practices
299with regard to the prescribing of certain drugs as specified in
300the General Appropriations Act and ensuring cost-effective
301prescribing practices.
302     15.14.  The agency may require prior authorization for the
303off-label use of Medicaid-covered prescribed drugs as specified
304in the General Appropriations Act. The agency may, but is not
305required to, preauthorize the use of a product for an indication
306not in the approved labeling. Prior authorization may require
307the prescribing professional to provide information about the
308rationale and supporting medical evidence for the off-label use
309of a drug.
310     16.15.  The agency shall implement a return and reuse


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