F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
HB 491 2024
1 A bill to be entitled
2 An act relating to access to appropriate medication
3 for serious mental illness; amending s. 409.901, F.S.;
4 defining the term "serious mental illness"; amending
5 s. 409.912, F.S.; requiring the Agency for Health Care
6 Administration to approve drug products for Medicaid
7 recipients for the treatment of serious mental illness
8 without step-therapy prior authorization under certain
9 circumstances; amending s. 409.910, F.S.; conforming a
10 cross-reference; directing the agency to include the
11 rate impact of this act in certain program rates that
12 become effective on a date certain; providing an
13 effective date.
14
15 Be It Enacted by the Legislature of the State of Florida:
16
17 Section 1. Subsections (27) and (28) of section 409.901,
18 Florida Statutes, are renumbered as subsections (28) and (29),
19 respectively, and a new subsection (27) is added to that
20 section, to read:
21 409.901 Definitions; ss. 409.901-409.920.—As used in ss.
22 409.901-409.920, except as otherwise specifically provided, the
23 term:
24 (27) "Serious mental illness" means any of the following
25 psychiatric disorders as defined by the American Psychiatric
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26 Association in the Diagnostic and Statistical Manual of Mental
27 Disorders, Fifth Edition:
28 (a) Bipolar disorder, including hypomanic, manic,
29 depressive, and mixed-feature episodes.
30 (b) Depression in childhood or adolescence.
31 (c) Major depressive disorders, including single and
32 recurrent depressive episodes.
33 (d) Obsessive-compulsive disorder.
34 (e) Paranoid personality disorder or other psychotic
35 disorders.
36 (f) Schizoaffective disorder, including bipolar or
37 depressive symptoms.
38 (g) Schizophrenia.
39 Section 2. Paragraph (a) of subsection (5) of section
40 409.912, Florida Statutes, is amended to read:
41 409.912 Cost-effective purchasing of health care.—The
42 agency shall purchase goods and services for Medicaid recipients
43 in the most cost-effective manner consistent with the delivery
44 of quality medical care. To ensure that medical services are
45 effectively utilized, the agency may, in any case, require a
46 confirmation or second physician's opinion of the correct
47 diagnosis for purposes of authorizing future services under the
48 Medicaid program. This section does not restrict access to
49 emergency services or poststabilization care services as defined
50 in 42 C.F.R. s. 438.114. Such confirmation or second opinion
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51 shall be rendered in a manner approved by the agency. The agency
52 shall maximize the use of prepaid per capita and prep aid
53 aggregate fixed-sum basis services when appropriate and other
54 alternative service delivery and reimbursement methodologies,
55 including competitive bidding pursuant to s. 287.057, designed
56 to facilitate the cost-effective purchase of a case-managed
57 continuum of care. The agency shall also require providers to
58 minimize the exposure of recipients to the need for acute
59 inpatient, custodial, and other institutional care and the
60 inappropriate or unnecessary use of high-cost services. The
61 agency shall contract with a vendor to monitor and evaluate the
62 clinical practice patterns of providers in order to identify
63 trends that are outside the normal practice patterns of a
64 provider's professional peers or the national guidelines of a
65 provider's professional association. The vendor must be able to
66 provide information and counseling to a provider whose practice
67 patterns are outside the norms, in consultation with the agency,
68 to improve patient care and reduce inappropriate utilization.
69 The agency may mandate prior authorization, drug therapy
70 management, or disease management participation for certain
71 populations of Medicaid beneficiaries, certain drug classes, or
72 particular drugs to prevent fraud, abuse, overuse, and possible
73 dangerous drug interactions. The Pharmaceutical and Therapeutics
74 Committee shall make recommendations to the agency on drugs for
75 which prior authorization is required. The agency shall inform
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76 the Pharmaceutical and Therapeutics Committee of its decisions
77 regarding drugs subject to prior authorization. The agency is
78 authorized to limit the entities it contracts with or enrolls as
79 Medicaid providers by developing a provider network through
80 provider credentialing. The agency may competitively bid single -
81 source-provider contracts if procurement of goods or services
82 results in demonstrated cost savings to the state without
83 limiting access to care. The agency may limit its network based
84 on the assessment of beneficiary access to care, provider
85 availability, provider quality standards, time and distance
86 standards for access to care, the cultural competence of the
87 provider network, demographic characteristics of Medicaid
88 beneficiaries, practice and provider-to-beneficiary standards,
89 appointment wait times, beneficiary use of services, provider
90 turnover, provider profiling, provider licensure history,
91 previous program integrity investigations and findings, peer
92 review, provider Medicaid policy and billing compliance records,
93 clinical and medical record audits, and other factors. Providers
94 are not entitled to enrollment in the Medicaid provider network.
95 The agency shall determine instances in which allowing Medicaid
96 beneficiaries to purchase durable medical equipment and other
97 goods is less expensive to the Medicaid program than long-term
98 rental of the equipment or goods. The agency may establish rules
99 to facilitate purchases in lieu of long-term rentals in order to
100 protect against fraud and abuse in the Medicaid program as
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101 defined in s. 409.913. The agency may seek federal waivers
102 necessary to administer these policies.
103 (5)(a) The agency shall implement a Medicaid prescribed -
104 drug spending-control program that includes the following
105 components:
106 1. A Medicaid preferred drug list, which shall be a
107 listing of cost-effective therapeutic options recommended by the
108 Medicaid Pharmacy and Therapeutics Committee established
109 pursuant to s. 409.91195 and adopted by the agency for each
110 therapeutic class on the preferred drug list. At the discretion
111 of the committee, and when feasible, the preferred drug list
112 should include at least two products in a therapeutic class. The
113 agency may post the preferred drug list and updates to the list
114 on an Internet website without following the rulemaking
115 procedures of chapter 120. Antiretroviral agents are excluded
116 from the preferred drug list. The agency shall also limit the
117 amount of a prescribed drug dispensed to no more than a 34 -day
118 supply unless the drug products' smallest marketed package is
119 greater than a 34-day supply, or the drug is determined by the
120 agency to be a maintenance drug in which case a 100 -day maximum
121 supply may be authorized. The agency may seek any federal
122 waivers necessary to implement these cost-control programs and
123 to continue participation in the federal Medicaid rebate
124 program, or alternatively to negotiate state-only manufacturer
125 rebates. The agency may adopt rules to administer this
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126 subparagraph. The agency shall continue to provide unlimited
127 contraceptive drugs and items. The agency must establish
128 procedures to ensure that:
129 a. There is a response to a request for prior
130 authorization by telephone or other telecommunication device
131 within 24 hours after receipt of a request for prior
132 authorization; and
133 b. A 72-hour supply of the drug prescribed is provided in
134 an emergency or when the agency does not provide a response
135 within 24 hours as required by sub-subparagraph a.
136 2. A provider of prescribed drugs is reimbursed in an
137 amount not to exceed the lesser of the actual acquisition cost
138 based on the Centers for Medicare and Medicaid Services National
139 Average Drug Acquisition Cost pricing files plus a professional
140 dispensing fee, the wholesale acquisition cost plus a
141 professional dispensing fee, the state maximum allowable cost
142 plus a professional dispensing fee, or the usual and customary
143 charge billed by the provider.
144 3. The agency shall develop and implement a process for
145 managing the drug therapies of Medicaid recipients who are using
146 significant numbers of prescribed drugs each month. The
147 management process may include, but is not limited to,
148 comprehensive, physician-directed medical-record reviews, claims
149 analyses, and case evaluations to determine the medical
150 necessity and appropriateness of a patient's treatment plan and
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151 drug therapies. The agency may contract with a private
152 organization to provide drug-program-management services. The
153 Medicaid drug benefit management program shall include
154 initiatives to manage drug therapies for HIV/AIDS pat ients,
155 patients using 20 or more unique prescriptions in a 180 -day
156 period, and the top 1,000 patients in annual spending. The
157 agency shall enroll any Medicaid recipient in the drug benefit
158 management program if he or she meets the specifications of this
159 provision and is not enrolled in a Medicaid health maintenance
160 organization.
161 4. The agency may limit the size of its pharmacy network
162 based on need, competitive bidding, price negotiations,
163 credentialing, or similar criteria. The agency shall give
164 special consideration to rural areas in determining the size and
165 location of pharmacies included in the Medicaid pharmacy
166 network. A pharmacy credentialing process may include criteria
167 such as a pharmacy's full-service status, location, size,
168 patient educational programs, patient consultation, disease
169 management services, and other characteristics. The agency may
170 impose a moratorium on Medicaid pharmacy enrollment if it is
171 determined that it has a sufficient number of Medicaid-
172 participating providers. The agency must allow dispensing
173 practitioners to participate as a part of the Medicaid pharmacy
174 network regardless of the practitioner's proximity to any other
175 entity that is dispensing prescription drugs under the Medicaid
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176 program. A dispensing practitioner must meet all credentialing
177 requirements applicable to his or her practice, as determined by
178 the agency.
179 5. The agency shall develop and implement a program that
180 requires Medicaid practitioners who issue written prescriptions
181 for medicinal drugs to use a counterfeit-proof prescription pad
182 for Medicaid prescriptions. The agency shall require the use of
183 standardized counterfeit-proof prescription pads by prescribers
184 who issue written prescriptions for Medicaid recipients. The
185 agency may implement the program in targeted geographic areas or
186 statewide.
187 6. The agency may enter into arrangements that require
188 manufacturers of generic drugs prescribed to Medicaid recipients
189 to provide rebates of at least 15.1 percent of the average
190 manufacturer price for the manufacturer's generic products.
191 These arrangements must shall require that if a generic-drug
192 manufacturer pays federal rebates for Medicaid-reimbursed drugs
193 at a level below 15.1 percent, the manufacturer must provide a
194 supplemental rebate to the state in an amount necessary to
195 achieve a 15.1-percent rebate level.
196 7. The agency may establish a preferred drug list as
197 described in this subsection, and, pursuant to the establishment
198 of such preferred drug list, negotiate supplemental rebates from
199 manufacturers that are in addition to those required by Title
200 XIX of the Social Security Act and at no less than 14 percent of
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201 the average manufacturer price as defined in 42 U.S.C. s. 1936
202 on the last day of a quarter unless the federal or supplemental
203 rebate, or both, equals or exceeds 29 percent. There is no upper
204 limit on the supplemental rebates the agency may negotiate. The
205 agency may determine that specific products, brand-name or
206 generic, are competitive at lower rebate percentages. Agreement
207 to pay the minimum supplemental rebate percentage guarantees a
208 manufacturer that the Medicaid Pharmaceutical and Therapeutics
209 Committee will consider a product for inclusion on the preferred
210 drug list. However, a pharmaceutical manufacturer is not
211 guaranteed placement on the preferred drug list by simply paying
212 the