FL
Florida House Bill H0183

Florida 2023 Regular Session

Florida House Bill H0183 Compare Versions

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1010 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
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1414 A bill to be entitled 1
1515 An act relating to Medicaid step -therapy protocols for 2
1616 drugs for serious mental illness treatments; amending 3
1717 s. 409.901, F.S.; defining the term "serious mental 4
1818 illness"; amending s. 409.912, F.S.; requiring the 5
1919 Agency for Health Care Administration to approve drug 6
2020 products for Medicaid recipients for the treatment of 7
2121 serious mental illness without step -therapy prior 8
2222 authorization under certain circumstances; amen ding s. 9
23-409.910, F.S.; conforming a cross -reference; directing 10
24-the agency to include the rate impact of this act in 11
25-certain program rates that become effective on a 12
26-specified date; providing an effective date. 13
23+409.910, F.S.; conforming a cross -reference; providing 10
24+an effective date. 11
25+ 12
26+Be It Enacted by the Legislature of the State of Florida: 13
2727 14
28-Be It Enacted by the Legislature of the S tate of Florida: 15
29- 16
30- Section 1. Present subsections (27) and (28) of section 17
31-409.901, Florida Statutes, are redesignated as subsections (28) 18
32-and (29), respectively, and a new subsection (27) is added to 19
33-that section, to read: 20
34- 409.901 Definitions; ss. 40 9.901-409.920.—As used in ss. 21
35-409.901-409.920, except as otherwise specifically provided, the 22
36-term: 23
37- (27) "Serious mental illness" means any of the following 24
38-psychiatric disorders as defined by the American Psychiatric 25
28+ Section 1. Present subsections (27) and (28) of section 15
29+409.901, Florida Statutes, are redesignated as s ubsections (28) 16
30+and (29), respectively, and a new subsection (27) is added to 17
31+that section, to read: 18
32+ 409.901 Definitions; ss. 409.901 -409.920.—As used in ss. 19
33+409.901-409.920, except as otherwise specifically provided, the 20
34+term: 21
35+ (27) "Serious mental ill ness" means any of the following 22
36+psychiatric disorders as defined by the American Psychiatric 23
37+Association in the Diagnostic and Statistical Manual of Mental 24
38+Disorders, Fifth Edition: 25
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4747 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
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51-Association in the Diagnostic and St atistical Manual of Mental 26
52-Disorders, Fifth Edition: 27
53- (a) Bipolar disorders, including hypomanic, manic, 28
54-depressive, and mixed -feature episodes. 29
55- (b) Depression in childhood or adolescence. 30
56- (c) Major depressive disorders, including single and 31
57-recurrent depressive episodes. 32
58- (d) Obsessive-compulsive disorders. 33
59- (e) Paranoid personality disorder or other psychotic 34
60-disorders. 35
61- (f) Schizoaffective disorders, including bipolar or 36
62-depressive symptoms. 37
63- (g) Schizophrenia. 38
64- Section 2. Paragraph (a) of su bsection (5) of section 39
65-409.912, Florida Statutes, is amended to read: 40
66- 409.912 Cost-effective purchasing of health care. —The 41
67-agency shall purchase goods and services for Medicaid recipients 42
68-in the most cost-effective manner consistent with the delivery 43
69-of quality medical care. To ensure that medical services are 44
70-effectively utilized, the agency may, in any case, require a 45
71-confirmation or second physician's opinion of the correct 46
72-diagnosis for purposes of authorizing future services under the 47
73-Medicaid program. This section does not restrict access to 48
74-emergency services or poststabilization care services as defined 49
75-in 42 C.F.R. s. 438.114. Such confirmation or second opinion 50
51+ (a) Bipolar disorders, including hypomanic, manic, 26
52+depressive, and mixe d-feature episodes. 27
53+ (b) Depression in childhood or adolescence. 28
54+ (c) Major depressive disorders, including single and 29
55+recurrent depressive episodes. 30
56+ (d) Obsessive-compulsive disorders. 31
57+ (e) Paranoid personality disorder or other psychotic 32
58+disorders. 33
59+ (f) Schizoaffective disorders, including bipolar or 34
60+depressive symptoms. 35
61+ (g) Schizophrenia. 36
62+ Section 2. Paragraph (a) of subsection (5) of section 37
63+409.912, Florida Statutes, is amended to read: 38
64+ 409.912 Cost-effective purchasing of health care. —The 39
65+agency shall purchase goods and services for Medicaid recipients 40
66+in the most cost-effective manner consistent with the delivery 41
67+of quality medical care. To ensure that medical services are 42
68+effectively utilized, the agency may, in any case, require a 43
69+confirmation or second physician's opinion of the correct 44
70+diagnosis for purposes of authorizing future services under the 45
71+Medicaid program. This section does not restrict access to 46
72+emergency services or poststabilization care services as defined 47
73+in 42 C.F.R. s. 438.114. Such confirmation or second opinion 48
74+shall be rendered in a manner approved by the agency. The agency 49
75+shall maximize the use of prepaid per capita and prepaid 50
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8484 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
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88-shall be rendered in a manner approved by the agency. The agency 51
89-shall maximize the use of prepaid per capita and prepaid 52
90-aggregate fixed-sum basis services when appropriate and other 53
91-alternative service delivery and reimbursement methodologies, 54
92-including competitive bidding pursuant to s. 287.057, designed 55
93-to facilitate the cost -effective purchase of a case -managed 56
94-continuum of care. The agency shall also require providers to 57
95-minimize the exposure of recipients to the need for acute 58
96-inpatient, custodial, and other institutional care and the 59
97-inappropriate or unnecessary use of high -cost services. The 60
98-agency shall contract with a vendor to monitor and evaluate the 61
99-clinical practice patterns of providers in order to identify 62
100-trends that are outside the normal practice patterns of a 63
101-provider's professional peers or the national guidelines of a 64
102-provider's professional association. The vendor must be able to 65
103-provide information and counseling to a provider whose practice 66
104-patterns are outside the norms, in consultation with the agency, 67
105-to improve patient care and reduce inappropriate utilization. 68
106-The agency may mandate prior authorization, drug therapy 69
107-management, or disease management participation for certain 70
108-populations of Medicaid beneficiaries, certain drug classes, or 71
109-particular drugs to prevent fraud, abuse, overuse, and possible 72
110-dangerous drug interactions. The Pharmaceutical and Therapeutics 73
111-Committee shall make recommendations to the agency on drugs for 74
112-which prior authorization is required. The agency shall inform 75
88+aggregate fixed-sum basis services when appropriate and other 51
89+alternative service delive ry and reimbursement methodologies, 52
90+including competitive bidding pursuant to s. 287.057, designed 53
91+to facilitate the cost -effective purchase of a case -managed 54
92+continuum of care. The agency shall also require providers to 55
93+minimize the exposure of recipients to the need for acute 56
94+inpatient, custodial, and other institutional care and the 57
95+inappropriate or unnecessary use of high -cost services. The 58
96+agency shall contract with a vendor to monitor and evaluate the 59
97+clinical practice patterns of providers in order t o identify 60
98+trends that are outside the normal practice patterns of a 61
99+provider's professional peers or the national guidelines of a 62
100+provider's professional association. The vendor must be able to 63
101+provide information and counseling to a provider whose practi ce 64
102+patterns are outside the norms, in consultation with the agency, 65
103+to improve patient care and reduce inappropriate utilization. 66
104+The agency may mandate prior authorization, drug therapy 67
105+management, or disease management participation for certain 68
106+populations of Medicaid beneficiaries, certain drug classes, or 69
107+particular drugs to prevent fraud, abuse, overuse, and possible 70
108+dangerous drug interactions. The Pharmaceutical and Therapeutics 71
109+Committee shall make recommendations to the agency on drugs for 72
110+which prior authorization is required. The agency shall inform 73
111+the Pharmaceutical and Therapeutics Committee of its decisions 74
112+regarding drugs subject to prior authorization. The agency is 75
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121121 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
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125-the Pharmaceutical and Therapeutics Committee of its decisions 76
126-regarding drugs subject to prior authorization. The agency is 77
127-authorized to limit the entities it contracts with or enrolls as 78
128-Medicaid providers by developing a provider network through 79
129-provider credentialing. The agency may competitively bid single -80
130-source-provider contracts if procurement of goods or services 81
131-results in demonstrated cost savings to the state without 82
132-limiting access to care. The agency may limit its network based 83
133-on the assessment of beneficiary access to care, provider 84
134-availability, provider quality standards, time and distance 85
135-standards for access to care, the cultural competence of the 86
136-provider network, demographic characteristics of Medicaid 87
137-beneficiaries, practice and provider -to-beneficiary standards, 88
138-appointment wait times, beneficiary use of se rvices, provider 89
139-turnover, provider profiling, provider licensure history, 90
140-previous program integrity investigations and findings, peer 91
141-review, provider Medicaid policy and billing compliance records, 92
142-clinical and medical record audits, and other factors. Providers 93
143-are not entitled to enrollment in the Medicaid provider network. 94
144-The agency shall determine instances in which allowing Medicaid 95
145-beneficiaries to purchase durable medical equipment and other 96
146-goods is less expensive to the Medicaid program than lo ng-term 97
147-rental of the equipment or goods. The agency may establish rules 98
148-to facilitate purchases in lieu of long -term rentals in order to 99
149-protect against fraud and abuse in the Medicaid program as 100
125+authorized to limit the entities it contracts with or enrolls as 76
126+Medicaid providers by developing a provider network through 77
127+provider credentialing. The agency may competitively bid single -78
128+source-provider contracts if procurement of goods or services 79
129+results in demonstrated cost savings to the state without 80
130+limiting access to care . The agency may limit its network based 81
131+on the assessment of beneficiary access to care, provider 82
132+availability, provider quality standards, time and distance 83
133+standards for access to care, the cultural competence of the 84
134+provider network, demographic charac teristics of Medicaid 85
135+beneficiaries, practice and provider -to-beneficiary standards, 86
136+appointment wait times, beneficiary use of services, provider 87
137+turnover, provider profiling, provider licensure history, 88
138+previous program integrity investigations and findi ngs, peer 89
139+review, provider Medicaid policy and billing compliance records, 90
140+clinical and medical record audits, and other factors. Providers 91
141+are not entitled to enrollment in the Medicaid provider network. 92
142+The agency shall determine instances in which allow ing Medicaid 93
143+beneficiaries to purchase durable medical equipment and other 94
144+goods is less expensive to the Medicaid program than long -term 95
145+rental of the equipment or goods. The agency may establish rules 96
146+to facilitate purchases in lieu of long -term rentals in order to 97
147+protect against fraud and abuse in the Medicaid program as 98
148+defined in s. 409.913. The agency may seek federal waivers 99
149+necessary to administer these policies. 100
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158158 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
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162-defined in s. 409.913. The agency may seek federal waivers 101
163-necessary to administer these policies. 102
164- (5)(a) The agency shall implement a Medicaid prescribed -103
165-drug spending-control program that includes the following 104
166-components: 105
167- 1. A Medicaid preferred drug list, which shall be a 106
168-listing of cost-effective therapeutic options recommended by the 107
169-Medicaid Pharmacy and Therapeutics Committee established 108
170-pursuant to s. 409.91195 and adopted by the agency for each 109
171-therapeutic class on the preferred drug list. At the discretion 110
172-of the committee, and when feasible, the preferred drug list 111
173-should include at least two products in a therapeutic class. The 112
174-agency may post the preferred drug list and updates to the list 113
175-on an Internet website without following the rulemaking 114
176-procedures of chapter 120. Antiretroviral agents are excluded 115
177-from the preferred drug list. The agency shall also limit the 116
178-amount of a prescribed drug dispensed to no more than a 34 -day 117
179-supply unless the drug products' sma llest marketed package is 118
180-greater than a 34-day supply, or the drug is determined by the 119
181-agency to be a maintenance drug in which case a 100 -day maximum 120
182-supply may be authorized. The agency may seek any federal 121
183-waivers necessary to implement these cost -control programs and 122
184-to continue participation in the federal Medicaid rebate 123
185-program, or alternatively to negotiate state -only manufacturer 124
186-rebates. The agency may adopt rules to administer this 125
162+ (5)(a) The agency shall implement a Medicaid prescribed -101
163+drug spending-control program that includes the following 102
164+components: 103
165+ 1. A Medicaid preferred drug list, which shall be a 104
166+listing of cost-effective therapeutic options recommended by the 105
167+Medicaid Pharmacy and Therapeutics Committee established 106
168+pursuant to s. 409.91195 and adopted by the agency for each 107
169+therapeutic class on the preferred drug list. At the discretion 108
170+of the committee, and when feasible, the preferred drug list 109
171+should include at least two products in a therapeutic class. The 110
172+agency may post the preferred drug list and updates to the list 111
173+on an Internet website without following the rulemaking 112
174+procedures of chapter 120. Antiretroviral agents are excluded 113
175+from the preferred drug list. The agency shall also limit the 114
176+amount of a prescribed drug dispensed to no more than a 34 -day 115
177+supply unless the drug products' sma llest marketed package is 116
178+greater than a 34-day supply, or the drug is determined by the 117
179+agency to be a maintenance drug in which case a 100 -day maximum 118
180+supply may be authorized. The agency may seek any federal 119
181+waivers necessary to implement these cost -control programs and 120
182+to continue participation in the federal Medicaid rebate 121
183+program, or alternatively to negotiate state -only manufacturer 122
184+rebates. The agency may adopt rules to administer this 123
185+subparagraph. The agency shall continue to provide unlimited 124
186+contraceptive drugs and items. The agency must establish 125
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195195 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
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199-subparagraph. The agency shall continue to provide unlimited 126
200-contraceptive drugs and items. The agency must establish 127
201-procedures to ensure that: 128
202- a. There is a response to a request for prior 129
203-authorization by telephone or other telecommunication device 130
204-within 24 hours after receipt of a request for prior 131
205-authorization; and 132
206- b. A 72-hour supply of the drug prescribed is provided in 133
207-an emergency or when the agency does not provide a response 134
208-within 24 hours as required by sub -subparagraph a. 135
209- 2. A provider of prescribed drugs is reimbursed in an 136
210-amount not to exceed t he lesser of the actual acquisition cost 137
211-based on the Centers for Medicare and Medicaid Services National 138
212-Average Drug Acquisition Cost pricing files plus a professional 139
213-dispensing fee, the wholesale acquisition cost plus a 140
214-professional dispensing fee, the state maximum allowable cost 141
215-plus a professional dispensing fee, or the usual and customary 142
216-charge billed by the provider. 143
217- 3. The agency shall develop and implement a process for 144
218-managing the drug therapies of Medicaid recipients who are using 145
219-significant numbers of prescribed drugs each month. The 146
220-management process may include, but is not limited to, 147
221-comprehensive, physician -directed medical-record reviews, claims 148
222-analyses, and case evaluations to determine the medical 149
223-necessity and appropriateness of a patient's treatment plan and 150
199+procedures to ensure that: 126
200+ a. There is a response to a request for prior 127
201+authorization by telephone or other telecommunication device 128
202+within 24 hours after receipt of a request for prior 129
203+authorization; and 130
204+ b. A 72-hour supply of the drug prescribed is provided in 131
205+an emergency or when the agency does not provide a response 132
206+within 24 hours as required by sub -subparagraph a. 133
207+ 2. A provider of prescribed drugs is reimbursed in an 134
208+amount not to exceed t he lesser of the actual acquisition cost 135
209+based on the Centers for Medicare and Medicaid Services National 136
210+Average Drug Acquisition Cost pricing files plus a professional 137
211+dispensing fee, the wholesale acquisition cost plus a 138
212+professional dispensing fee, the state maximum allowable cost 139
213+plus a professional dispensing fee, or the usual and customary 140
214+charge billed by the provider. 141
215+ 3. The agency shall develop and implement a process for 142
216+managing the drug therapies of Medicaid recipients who are using 143
217+significant numbers of prescribed drugs each month. The 144
218+management process may include, but is not limited to, 145
219+comprehensive, physician -directed medical-record reviews, claims 146
220+analyses, and case evaluations to determine the medical 147
221+necessity and appropriateness of a patient's treatment plan and 148
222+drug therapies. The agency may contract with a private 149
223+organization to provide drug -program-management services. The 150
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232232 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
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236-drug therapies. The agency may contract with a private 151
237-organization to provide drug -program-management services. The 152
238-Medicaid drug benefit management program shall include 153
239-initiatives to manage drug therapies for HIV/AIDS pat ients, 154
240-patients using 20 or more unique prescriptions in a 180 -day 155
241-period, and the top 1,000 patients in annual spending. The 156
242-agency shall enroll any Medicaid recipient in the drug benefit 157
243-management program if he or she meets the specifications of this 158
244-provision and is not enrolled in a Medicaid health maintenance 159
245-organization. 160
246- 4. The agency may limit the size of its pharmacy network 161
247-based on need, competitive bidding, price negotiations, 162
248-credentialing, or similar criteria. The agency shall give 163
249-special consideration to rural areas in determining the size and 164
250-location of pharmacies included in the Medicaid pharmacy 165
251-network. A pharmacy credentialing process may include criteria 166
252-such as a pharmacy's full -service status, location, size, 167
253-patient educational p rograms, patient consultation, disease 168
254-management services, and other characteristics. The agency may 169
255-impose a moratorium on Medicaid pharmacy enrollment if it is 170
256-determined that it has a sufficient number of Medicaid -171
257-participating providers. The agency mu st allow dispensing 172
258-practitioners to participate as a part of the Medicaid pharmacy 173
259-network regardless of the practitioner's proximity to any other 174
260-entity that is dispensing prescription drugs under the Medicaid 175
236+Medicaid drug benefit management program shall include 151
237+initiatives to manage drug therapies for HIV/AIDS pat ients, 152
238+patients using 20 or more unique prescriptions in a 180 -day 153
239+period, and the top 1,000 patients in annual spending. The 154
240+agency shall enroll any Medicaid recipient in the drug benefit 155
241+management program if he or she meets the specifications of this 156
242+provision and is not enrolled in a Medicaid health maintenance 157
243+organization. 158
244+ 4. The agency may limit the size of its pharmacy network 159
245+based on need, competitive bidding, price negotiations, 160
246+credentialing, or similar criteria. The agency shall give 161
247+special consideration to rural areas in determining the size and 162
248+location of pharmacies included in the Medicaid pharmacy 163
249+network. A pharmacy credentialing process may include criteria 164
250+such as a pharmacy's full -service status, location, size, 165
251+patient educational p rograms, patient consultation, disease 166
252+management services, and other characteristics. The agency may 167
253+impose a moratorium on Medicaid pharmacy enrollment if it is 168
254+determined that it has a sufficient number of Medicaid -169
255+participating providers. The agency mu st allow dispensing 170
256+practitioners to participate as a part of the Medicaid pharmacy 171
257+network regardless of the practitioner's proximity to any other 172
258+entity that is dispensing prescription drugs under the Medicaid 173
259+program. A dispensing practitioner must meet all credentialing 174
260+requirements applicable to his or her practice, as determined by 175
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269269 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
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273-program. A dispensing practitioner must meet all credentialing 176
274-requirements applicable to his or her practice, as determined by 177
275-the agency. 178
276- 5. The agency shall develop and implement a program that 179
277-requires Medicaid practitioners who issue written prescriptions 180
278-for medicinal drugs to use a counterf eit-proof prescription pad 181
279-for Medicaid prescriptions. The agency shall require the use of 182
280-standardized counterfeit -proof prescription pads by prescribers 183
281-who issue written prescriptions for Medicaid recipients. The 184
282-agency may implement the program in targ eted geographic areas or 185
283-statewide. 186
284- 6. The agency may enter into arrangements that require 187
285-manufacturers of generic drugs prescribed to Medicaid recipients 188
286-to provide rebates of at least 15.1 percent of the average 189
287-manufacturer price for the manufacturer 's generic products. 190
288-These arrangements must shall require that if a generic -drug 191
289-manufacturer pays federal rebates for Medicaid -reimbursed drugs 192
290-at a level below 15.1 percent, the manufacturer must provide a 193
291-supplemental rebate to the state in an amount n ecessary to 194
292-achieve a 15.1-percent rebate level. 195
293- 7. The agency may establish a preferred drug list as 196
294-described in this subsection, and, pursuant to the establishment 197
295-of such preferred drug list, negotiate supplemental rebates from 198
296-manufacturers that are in addition to those required by Title 199
297-XIX of the Social Security Act and at no less than 14 percent of 200
273+the agency. 176
274+ 5. The agency shall develop and implement a program that 177
275+requires Medicaid practitioners who issue written prescriptions 178
276+for medicinal drugs to use a counterf eit-proof prescription pad 179
277+for Medicaid prescriptions. The agency shall require the use of 180
278+standardized counterfeit -proof prescription pads by prescribers 181
279+who issue written prescriptions for Medicaid recipients. The 182
280+agency may implement the program in targ eted geographic areas or 183
281+statewide. 184
282+ 6. The agency may enter into arrangements that require 185
283+manufacturers of generic drugs prescribed to Medicaid recipients 186
284+to provide rebates of at least 15.1 percent of the average 187
285+manufacturer price for the manufacturer 's generic products. 188
286+These arrangements must shall require that if a generic -drug 189
287+manufacturer pays federal rebates for Medicaid -reimbursed drugs 190
288+at a level below 15.1 percent, the manufacturer must provide a 191
289+supplemental rebate to the state in an amount n ecessary to 192
290+achieve a 15.1-percent rebate level. 193
291+ 7. The agency may establish a preferred drug list as 194
292+described in this subsection, and, pursuant to the establishment 195
293+of such preferred drug list, negotiate supplemental rebates from 196
294+manufacturers that are in addition to those required by Title 197
295+XIX of the Social Security Act and at no less than 14 percent of 198
296+the average manufacturer price as defined in 42 U.S.C. s. 1936 199
297+on the last day of a quarter unless the federal or supplemental 200
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310-the average manufacturer price as defined in 42 U.S.C. s. 1936 201
311-on the last day of a quarter unless the federal or supplemental 202
312-rebate, or both, equals or exceeds 29 percent. There is no upper 203
313-limit on the supplemental rebates the agency may negotiate. The 204
314-agency may determine that specific products, brand -name or 205
315-generic, are competitive at lower rebate percentages. Agreement 206
316-to pay the minimum supplemen tal rebate percentage guarantees a 207
317-manufacturer that the Medicaid Pharmaceutical and Therapeutics 208
318-Committee will consider a product for inclusion on the preferred 209
319-drug list. However, a pharmaceutical manufacturer is not 210
320-guaranteed placement on the preferre d drug list by simply paying 211
321-the minimum supplemental rebate. Agency decisions will be made 212
322-on the clinical efficacy of a drug and recommendations of the 213
323-Medicaid Pharmaceutical and Therapeutics Committee, as well as 214
324-the price of competing products minus f ederal and state rebates. 215
325-The agency may contract with an outside agency or contractor to 216
326-conduct negotiations for supplemental rebates. For the purposes 217
327-of this section, the term "supplemental rebates" means cash 218
328-rebates. Value-added programs as a substit ution for supplemental 219
329-rebates are prohibited. The agency may seek any federal waivers 220
330-to implement this initiative. 221
331- 8.a. The agency may implement a Medicaid behavioral drug 222
332-management system. The agency may contract with a vendor that 223
333-has experience in operating behavioral drug management systems 224
334-to implement this program. The agency may seek federal waivers 225
310+rebate, or both, equals or exceeds 29 percent. There is no upper 201
311+limit on the supplemental rebates the agency may negotiate. The 202
312+agency may determine that specific products, brand -name or 203
313+generic, are competitive at lower rebate percentages. Agreement 204
314+to pay the minimum supplemen tal rebate percentage guarantees a 205
315+manufacturer that the Medicaid Pharmaceutical and Therapeutics 206
316+Committee will consider a product for inclusion on the preferred 207
317+drug list. However, a pharmaceutical manufacturer is not 208
318+guaranteed placement on the preferre d drug list by simply paying 209
319+the minimum supplemental rebate. Agency decisions will be made 210
320+on the clinical efficacy of a drug and recommendations of the 211
321+Medicaid Pharmaceutical and Therapeutics Committee, as well as 212
322+the price of competing products minus f ederal and state rebates. 213
323+The agency may contract with an outside agency or contractor to 214
324+conduct negotiations for supplemental rebates. For the purposes 215
325+of this section, the term "supplemental rebates" means cash 216
326+rebates. Value-added programs as a substit ution for supplemental 217
327+rebates are prohibited. The agency may seek any federal waivers 218
328+to implement this initiative. 219
329+ 8.a. The agency may implement a Medicaid behavioral drug 220
330+management system. The agency may contract with a vendor that 221
331+has experience in operating behavioral drug management systems 222
332+to implement this program. The agency may seek federal waivers 223
333+to implement this program. 224
334+ b. The agency, in conjunction with the Department of 225
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345345
346346
347-to implement this program. 226
348- b. The agency, in conjunction with the Department of 227
349-Children and Families, may implement the Medicaid behavioral 228
350-drug management system that is designed to improve the quality 229
351-of care and behavioral health prescribing practices based on 230
352-best practice guidelines, improve patient adherence to 231
353-medication plans, reduce clinical risk, and lower prescribed 232
354-drug costs and the ra te of inappropriate spending on Medicaid 233
355-behavioral drugs. The program may include the following 234
356-elements: 235
357- (I) Provide for the development and adoption of best 236
358-practice guidelines for behavioral health -related drugs such as 237
359-antipsychotics, antidepressant s, and medications for treating 238
360-bipolar disorders and other behavioral conditions; translate 239
361-them into practice; review behavioral health prescribers and 240
362-compare their prescribing patterns to a number of indicators 241
363-that are based on national standards; and determine deviations 242
364-from best practice guidelines. 243
365- (II) Implement processes for providing feedback to and 244
366-educating prescribers using best practice educational materials 245
367-and peer-to-peer consultation. 246
368- (III) Assess Medicaid beneficiaries who are outli ers in 247
369-their use of behavioral health drugs with regard to the numbers 248
370-and types of drugs taken, drug dosages, combination drug 249
371-therapies, and other indicators of improper use of behavioral 250
347+Children and Families, may implement the Medicaid behavioral 226
348+drug management system that is designed to improve the quality 227
349+of care and behavioral health prescribing practices based on 228
350+best practice guidelines, improve patient adherence to 229
351+medication plans, reduce clinical risk, and lower prescribed 230
352+drug costs and the ra te of inappropriate spending on Medicaid 231
353+behavioral drugs. The program may include the following 232
354+elements: 233
355+ (I) Provide for the development and adoption of best 234
356+practice guidelines for behavioral health -related drugs such as 235
357+antipsychotics, antidepressant s, and medications for treating 236
358+bipolar disorders and other behavioral conditions; translate 237
359+them into practice; review behavioral health prescribers and 238
360+compare their prescribing patterns to a number of indicators 239
361+that are based on national standards; and determine deviations 240
362+from best practice guidelines. 241
363+ (II) Implement processes for providing feedback to and 242
364+educating prescribers using best practice educational materials 243
365+and peer-to-peer consultation. 244
366+ (III) Assess Medicaid beneficiaries who are outli ers in 245
367+their use of behavioral health drugs with regard to the numbers 246
368+and types of drugs taken, drug dosages, combination drug 247
369+therapies, and other indicators of improper use of behavioral 248
370+health drugs. 249
371+ (IV) Alert prescribers to patients who fail to ref ill 250
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380380 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
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384-health drugs. 251
385- (IV) Alert prescribers to patients who fail to ref ill 252
386-prescriptions in a timely fashion, are prescribed multiple same -253
387-class behavioral health drugs, and may have other potential 254
388-medication problems. 255
389- (V) Track spending trends for behavioral health drugs and 256
390-deviation from best practice guidelines. 257
391- (VI) Use educational and technological approaches to 258
392-promote best practices, educate consumers, and train prescribers 259
393-in the use of practice guidelines. 260
394- (VII) Disseminate electronic and published materials. 261
395- (VIII) Hold statewide and regional conferences. 262
396- (IX) Implement a disease management program with a model 263
397-quality-based medication component for severely mentally ill 264
398-individuals and emotionally disturbed children who are high 265
399-users of care. 266
400- 9. The agency shall implement a Medicaid prescription drug 267
401-management system. 268
402- a. The agency may contract with a vendor that has 269
403-experience in operating prescription drug management systems in 270
404-order to implement this system. Any management system that is 271
405-implemented in accordance with this subparagraph must rely o n 272
406-cooperation between physicians and pharmacists to determine 273
407-appropriate practice patterns and clinical guidelines to improve 274
408-the prescribing, dispensing, and use of drugs in the Medicaid 275
384+prescriptions in a timely fashion, are prescribed multiple same -251
385+class behavioral health drugs, and may have other potential 252
386+medication problems. 253
387+ (V) Track spending trends for behavioral health drugs and 254
388+deviation from best practice guidelines. 255
389+ (VI) Use educational and technological approaches to 256
390+promote best practices, educate consumers, and train prescribers 257
391+in the use of practice guidelines. 258
392+ (VII) Disseminate electronic and published materials. 259
393+ (VIII) Hold statewide and regional conferences. 260
394+ (IX) Implement a disease management program with a model 261
395+quality-based medication component for severely mentally ill 262
396+individuals and emotionally disturbed children who are high 263
397+users of care. 264
398+ 9. The agency shall implement a Medicaid prescription drug 265
399+management system. 266
400+ a. The agency may contract with a vendor that has 267
401+experience in operating prescription drug management systems in 268
402+order to implement this system. Any management system that is 269
403+implemented in accordance with this subparagraph must rely o n 270
404+cooperation between physicians and pharmacists to determine 271
405+appropriate practice patterns and clinical guidelines to improve 272
406+the prescribing, dispensing, and use of drugs in the Medicaid 273
407+program. The agency may seek federal waivers to implement this 274
408+program. 275
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421-program. The agency may seek federal waivers to implement this 276
422-program. 277
423- b. The drug management system must be designed to improve 278
424-the quality of care and prescribing practices based on best 279
425-practice guidelines, improve patient adherence to medication 280
426-plans, reduce clinical risk, and lower prescribed drug costs and 281
427-the rate of inappropriate spending on Medicaid prescription 282
428-drugs. The program must: 283
429- (I) Provide for the adoption of best practice guidelines 284
430-for the prescribing and use of drugs in the Medicaid program, 285
431-including translating best practice guidelines into pra ctice; 286
432-reviewing prescriber patterns and comparing them to indicators 287
433-that are based on national standards and practice patterns of 288
434-clinical peers in their community, statewide, and nationally; 289
435-and determine deviations from best practice guidelines. 290
436- (II) Implement processes for providing feedback to and 291
437-educating prescribers using best practice educational materials 292
438-and peer-to-peer consultation. 293
439- (III) Assess Medicaid recipients who are outliers in their 294
440-use of a single or multiple prescription drugs wi th regard to 295
441-the numbers and types of drugs taken, drug dosages, combination 296
442-drug therapies, and other indicators of improper use of 297
443-prescription drugs. 298
444- (IV) Alert prescribers to recipients who fail to refill 299
445-prescriptions in a timely fashion, are prescr ibed multiple drugs 300
421+ b. The drug management system must be designed to improve 276
422+the quality of care and prescribing practices based on best 277
423+practice guidelines, improve patient adherence to medication 278
424+plans, reduce clinical risk, and lower prescribed drug costs and 279
425+the rate of inappropriate spending on Medicaid prescription 280
426+drugs. The program must: 281
427+ (I) Provide for the adoption of best practice guidelines 282
428+for the prescribing and use of drugs in the Medicaid program, 283
429+including translating best practice guidelines into pra ctice; 284
430+reviewing prescriber patterns and comparing them to indicators 285
431+that are based on national standards and practice patterns of 286
432+clinical peers in their community, statewide, and nationally; 287
433+and determine deviations from best practice guidelines. 288
434+ (II) Implement processes for providing feedback to and 289
435+educating prescribers using best practice educational materials 290
436+and peer-to-peer consultation. 291
437+ (III) Assess Medicaid recipients who are outliers in their 292
438+use of a single or multiple prescription drugs wi th regard to 293
439+the numbers and types of drugs taken, drug dosages, combination 294
440+drug therapies, and other indicators of improper use of 295
441+prescription drugs. 296
442+ (IV) Alert prescribers to recipients who fail to refill 297
443+prescriptions in a timely fashion, are prescr ibed multiple drugs 298
444+that may be redundant or contraindicated, or may have other 299
445+potential medication problems. 300
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454454 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
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457457
458-that may be redundant or contraindicated, or may have other 301
459-potential medication problems. 302
460- 10. The agency may contract for drug rebate 303
461-administration, including, but not limited to, calculating 304
462-rebate amounts, invoicing manufacturers, negotiating disputes 305
463-with manufacturers, and maintaining a database of rebate 306
464-collections. 307
465- 11. The agency may specify the preferred daily dosing form 308
466-or strength for the purpose of promoting best practices with 309
467-regard to the prescribing of certain drugs as specified in the 310
468-General Appropriations Act and ensuring cost -effective 311
469-prescribing practices. 312
470- 12. The agency may require prior authorization for 313
471-Medicaid-covered prescribed drugs. The agency may prior -314
472-authorize the use of a product: 315
473- a. For an indication not approved in labeling; 316
474- b. To comply with certain clinical guidelines; or 317
475- c. If the product has the potential for overuse, misuse, 318
476-or abuse. 319
477- 320
478-The agency may require the prescribing professional to provide 321
479-information about the rationale an d supporting medical evidence 322
480-for the use of a drug. The agency shall post prior 323
481-authorization, step-edit criteria and protocol, and updates to 324
482-the list of drugs that are subject to prior authorization on the 325
458+ 10. The agency may contract for drug rebate 301
459+administration, including, but not limited to, calculating 302
460+rebate amounts, invoicing manufacturers, negotiating disputes 303
461+with manufacturers, and maintaining a database of rebate 304
462+collections. 305
463+ 11. The agency may specify the preferred daily dosing form 306
464+or strength for the purpose of promoting best practices with 307
465+regard to the prescribing of certain drugs as specified in the 308
466+General Appropriations Act and ensuring cost -effective 309
467+prescribing practices. 310
468+ 12. The agency may require prior authorization for 311
469+Medicaid-covered prescribed drugs. The agency may prior -312
470+authorize the use of a product: 313
471+ a. For an indication not approved in labeling; 314
472+ b. To comply with certain clinical guidelines; or 315
473+ c. If the product has the potential for overuse, misuse, 316
474+or abuse. 317
475+ 318
476+The agency may require the prescribing professional to provide 319
477+information about the rationale an d supporting medical evidence 320
478+for the use of a drug. The agency shall post prior 321
479+authorization, step-edit criteria and protocol, and updates to 322
480+the list of drugs that are subject to prior authorization on the 323
481+agency's Internet website within 21 days after the prior 324
482+authorization and step -edit criteria and protocol and updates 325
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491491 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
492492
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495-agency's Internet website within 21 days after the prior 326
496-authorization and step -edit criteria and protocol and updates 327
497-are approved by the agency. For purposes of this subparagraph, 328
498-the term "step-edit" means an automatic electronic review of 329
499-certain medications subject to prior authorization. 330
500- 13. The agency, in conjunction with the Pharmaceutical and 331
501-Therapeutics Committee, may require age -related prior 332
502-authorizations for certain prescribed drugs. The agency may 333
503-preauthorize the use of a drug for a recipient who may not meet 334
504-the age requirement or ma y exceed the length of therapy for use 335
505-of this product as recommended by the manufacturer and approved 336
506-by the Food and Drug Administration. Prior authorization may 337
507-require the prescribing professional to provide information 338
508-about the rationale and supporti ng medical evidence for the use 339
509-of a drug. 340
510- 14. The agency shall implement a step -therapy prior 341
511-authorization approval process for medications excluded from the 342
512-preferred drug list. Medications listed on the preferred drug 343
513-list must be used within the pre vious 12 months before the 344
514-alternative medications that are not listed. The step -therapy 345
515-prior authorization may require the prescriber to use the 346
516-medications of a similar drug class or for a similar medical 347
517-indication unless contraindicated in the Food an d Drug 348
518-Administration labeling. The trial period between the specified 349
519-steps may vary according to the medical indication. The step -350
495+are approved by the agency. For purposes of this subparagraph, 326
496+the term "step-edit" means an automatic electronic review of 327
497+certain medications subject to prior authorization. 328
498+ 13. The agency, in conjunction with the Pharmaceutical and 329
499+Therapeutics Committee, may require age -related prior 330
500+authorizations for certain prescribed drugs. The agency may 331
501+preauthorize the use of a drug for a recipient who may not meet 332
502+the age requirement or ma y exceed the length of therapy for use 333
503+of this product as recommended by the manufacturer and approved 334
504+by the Food and Drug Administration. Prior authorization may 335
505+require the prescribing professional to provide information 336
506+about the rationale and supporti ng medical evidence for the use 337
507+of a drug. 338
508+ 14. The agency shall implement a step -therapy prior 339
509+authorization approval process for medications excluded from the 340
510+preferred drug list. Medications listed on the preferred drug 341
511+list must be used within the pre vious 12 months before the 342
512+alternative medications that are not listed. The step -therapy 343
513+prior authorization may require the prescriber to use the 344
514+medications of a similar drug class or for a similar medical 345
515+indication unless contraindicated in the Food an d Drug 346
516+Administration labeling. The trial period between the specified 347
517+steps may vary according to the medical indication. The step -348
518+therapy approval process must shall be developed in accordance 349
519+with the committee as stated in s. 409.91195(7) and (8). A dr ug 350
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528528 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
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532-therapy approval process must shall be developed in accordance 351
533-with the committee as stated in s. 409.91195(7) and (8). A dr ug 352
534-product may be approved or, in the case of a drug product for 353
535-the treatment of a serious mental illness, must be approved 354
536-without meeting the step -therapy prior authorization criteria if 355
537-the prescribing physician provides the agency with additional 356
538-written medical or clinical documentation that the product is 357
539-medically necessary because: 358
540- a. There is not a drug on the preferred drug list to treat 359
541-the disease or medical condition which is an acceptable clinical 360
542-alternative; 361
543- b. The alternatives have bee n ineffective in the treatment 362
544-of the beneficiary's disease; 363
545- c. The drug product or medication of a similar drug class 364
546-is prescribed for the treatment of a serious mental illness 365
547-schizophrenia or schizotypal or delusional disorders ; prior 366
548-authorization has been granted previously for the prescribed 367
549-drug; and the medication was dispensed to the patient during the 368
550-previous 12 months; or 369
551- d. Based on historical evidence and known characteristics 370
552-of the patient and the drug, the drug is likely to be 371
553-ineffective, or the number of doses have been ineffective. 372
554- 373
555-The agency shall work with the physician to determine the best 374
556-alternative for the patient. The agency may adopt rules waiving 375
532+product may be approved or, in the case of a drug product for 351
533+the treatment of a serious mental illness, must be approved 352
534+without meeting the step -therapy prior authorization criteria if 353
535+the prescribing physician provides the agency with additional 354
536+written medical or clinical documentation that the product is 355
537+medically necessary because: 356
538+ a. There is not a drug on the preferred drug list to treat 357
539+the disease or medical condition which is an acceptable clinical 358
540+alternative; 359
541+ b. The alternatives have bee n ineffective in the treatment 360
542+of the beneficiary's disease; 361
543+ c. The drug product or medication of a similar drug class 362
544+is prescribed for the treatment of a serious mental illness 363
545+schizophrenia or schizotypal or delusional disorders ; prior 364
546+authorization has been granted previously for the prescribed 365
547+drug; and the medication was dispensed to the patient during the 366
548+previous 12 months; or 367
549+ d. Based on historical evidence and known characteristics 368
550+of the patient and the drug, the drug is likely to be 369
551+ineffective, or the number of doses have been ineffective. 370
552+ 371
553+The agency shall work with the physician to determine the best 372
554+alternative for the patient. The agency may adopt rules waiving 373
555+the requirements for written clinical documentation for specific 374
556+drugs in limited clinical situations. 375
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565565 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
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569-the requirements for written clinical documentation for specific 376
570-drugs in limited clinical situations. 377
571- 15. The agency shall implement a return and reuse program 378
572-for drugs dispensed by pharmacies to institutional recipients, 379
573-which includes payment of a $5 restocking fee for the 380
574-implementation and operation of the program. The retu rn and 381
575-reuse program shall be implemented electronically and in a 382
576-manner that promotes efficiency. The program must permit a 383
577-pharmacy to exclude drugs from the program if it is not 384
578-practical or cost-effective for the drug to be included and must 385
579-provide for the return to inventory of drugs that cannot be 386
580-credited or returned in a cost -effective manner. The agency 387
581-shall determine if the program has reduced the amount of 388
582-Medicaid prescription drugs which are destroyed on an annual 389
583-basis and if there are addit ional ways to ensure more 390
584-prescription drugs are not destroyed which could safely be 391
585-reused. 392
586- Section 3. Paragraph (a) of subsection (20) of section 393
587-409.910, Florida Statutes, is amended to read: 394
588- 409.910 Responsibility for payments on behalf of Medica id-395
589-eligible persons when other parties are liable. — 396
590- (20)(a) Entities providing health insurance as defined in 397
591-s. 624.603, health maintenance organizations and prepaid health 398
592-clinics as defined in chapter 641, and, on behalf of their 399
593-clients, third-party administrators, pharmacy benefits managers, 400
569+ 15. The agency shall implement a return and reuse program 376
570+for drugs dispensed by pharmacies to institutional recipients, 377
571+which includes payment of a $5 restocking fee for the 378
572+implementation and operation of the program. The retu rn and 379
573+reuse program shall be implemented electronically and in a 380
574+manner that promotes efficiency. The program must permit a 381
575+pharmacy to exclude drugs from the program if it is not 382
576+practical or cost-effective for the drug to be included and must 383
577+provide for the return to inventory of drugs that cannot be 384
578+credited or returned in a cost -effective manner. The agency 385
579+shall determine if the program has reduced the amount of 386
580+Medicaid prescription drugs which are destroyed on an annual 387
581+basis and if there are addit ional ways to ensure more 388
582+prescription drugs are not destroyed which could safely be 389
583+reused. 390
584+ Section 3. Paragraph (a) of subsection (20) of section 391
585+409.910, Florida Statutes, is amended to read: 392
586+ 409.910 Responsibility for payments on behalf of Medica id-393
587+eligible persons when other parties are liable. — 394
588+ (20)(a) Entities providing health insurance as defined in 395
589+s. 624.603, health maintenance organizations and prepaid health 396
590+clinics as defined in chapter 641, and, on behalf of their 397
591+clients, third-party administrators, pharmacy benefits managers, 398
592+and any other third parties, as defined in s. 409.901(28) s. 399
593+409.901(27), which are legally responsible for payment of a 400
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602602 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
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605605
606-and any other third parties, as defined in s. 409.901(28) s. 401
607-409.901(27), which are legally responsible for payment of a 402
608-claim for a health care item or service as a condition of doing 403
609-business in this the state or providing coverage to residents of 404
610-this state, shall provide such records and information as are 405
611-necessary to accomplish the purpose of this section, unless such 406
612-requirement results in an unreasonable burden. 407
613- Section 4. The Agency for Health Care Ad ministration is 408
614-directed to include the rate impact of this act in the Medicaid 409
615-managed medical assistance program and long -term care managed 410
616-care program rates that become effective on October 1, 2023. 411
617- Section 5. This act shall take effect October 1, 2023. 412
606+claim for a health care item or service as a condition of doing 401
607+business in this the state or providing coverage to residents of 402
608+this state, shall provide such records and information as are 403
609+necessary to accomplish the purpose of this section, unless such 404
610+requirement results in an unreasonable burden. 405
611+ Section 4. This act shall take effect July 1, 2023. 406