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9 | 9 | | Page 1 of 17 |
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10 | 10 | | 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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13 | 13 | | |
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14 | 14 | | A bill to be entitled 1 |
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15 | 15 | | An act relating to access to appropriate medication 2 |
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16 | 16 | | for serious mental illness; amending s. 409.901, F.S.; 3 |
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17 | 17 | | defining the term "serious mental illness"; amending 4 |
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18 | 18 | | s. 409.912, F.S.; requiring the Agency for Health Care 5 |
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19 | 19 | | Administration to approve drug products for Medicaid 6 |
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20 | 20 | | recipients for the treatment of serious mental illness 7 |
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21 | 21 | | without step-therapy prior authorization under certain 8 |
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22 | 22 | | circumstances; amending s. 409.910, F. S.; conforming a 9 |
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23 | 23 | | cross-reference; directing the agency to include the 10 |
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24 | 24 | | rate impact of this act in certain program rates that 11 |
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25 | 25 | | become effective on a date certain; providing an 12 |
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26 | 26 | | effective date. 13 |
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27 | 27 | | 14 |
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28 | 28 | | Be It Enacted by the Legislature of the State of Florida: 15 |
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29 | 29 | | 16 |
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30 | 30 | | Section 1. Subsections (27) and (28) of section 409.901, 17 |
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31 | 31 | | Florida Statutes, are renumbered as subsections (28) and (29), 18 |
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32 | 32 | | respectively, and a new subsection (27) is added to that 19 |
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33 | 33 | | section, to read: 20 |
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34 | 34 | | 409.901 Definitions; ss. 409.901 -409.920.—As used in ss. 21 |
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35 | 35 | | 409.901-409.920, except as otherwise specifically provided, the 22 |
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36 | 36 | | term: 23 |
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37 | 37 | | (27) "Serious mental illness" means any of the following 24 |
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38 | 38 | | psychiatric disorders as defined by the American Psychiatric 25 |
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47 | 47 | | 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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48 | 48 | | |
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50 | 50 | | |
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51 | 51 | | Association in the Diagnostic and Statistical Manual of Mental 26 |
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52 | 52 | | Disorders, Fifth Edition: 27 |
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53 | 53 | | (a) Bipolar disorder, including hypomanic, manic, 28 |
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54 | 54 | | depressive, and mixed -feature episodes. 29 |
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55 | 55 | | (b) Depression in childhood or adolescence. 30 |
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56 | 56 | | (c) Major depressive disorders, including single and 31 |
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57 | 57 | | recurrent depressive episodes. 32 |
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58 | 58 | | (d) Obsessive-compulsive disorder. 33 |
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59 | 59 | | (e) Paranoid personality disorder or other psychotic 34 |
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60 | 60 | | disorders. 35 |
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61 | 61 | | (f) Schizoaffective disorder, including bipolar or 36 |
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62 | 62 | | depressive symptoms. 37 |
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63 | 63 | | (g) Schizophrenia. 38 |
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64 | 64 | | Section 2. Paragraph (a) of subsection (5) of section 39 |
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65 | 65 | | 409.912, Florida Statutes, is amended to read: 40 |
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66 | 66 | | 409.912 Cost-effective purchasing of health care. —The 41 |
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67 | 67 | | agency shall purchase goods and services for Medicaid recipients 42 |
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68 | 68 | | in the most cost-effective manner consistent with the delivery 43 |
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69 | 69 | | of quality medical care. To ensure that medical services are 44 |
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70 | 70 | | effectively utilized, the agency may, in any case, require a 45 |
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71 | 71 | | confirmation or second physician's opinion of the correct 46 |
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72 | 72 | | diagnosis for purposes of authorizing future services under the 47 |
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73 | 73 | | Medicaid program. This section does not restric t access to 48 |
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74 | 74 | | emergency services or poststabilization care services as defined 49 |
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75 | 75 | | in 42 C.F.R. s. 438.114. Such confirmation or second opinion 50 |
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76 | 76 | | |
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84 | 84 | | 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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85 | 85 | | |
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88 | 88 | | shall be rendered in a manner approved by the agency. The agency 51 |
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89 | 89 | | shall maximize the use of prepaid per capita and prep aid 52 |
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90 | 90 | | aggregate fixed-sum basis services when appropriate and other 53 |
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91 | 91 | | alternative service delivery and reimbursement methodologies, 54 |
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92 | 92 | | including competitive bidding pursuant to s. 287.057, designed 55 |
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93 | 93 | | to facilitate the cost -effective purchase of a case -managed 56 |
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94 | 94 | | continuum of care. The agency shall also require providers to 57 |
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95 | 95 | | minimize the exposure of recipients to the need for acute 58 |
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96 | 96 | | inpatient, custodial, and other institutional care and the 59 |
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97 | 97 | | inappropriate or unnecessary use of high -cost services. The 60 |
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98 | 98 | | agency shall contract with a vendor to monitor and evaluate the 61 |
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99 | 99 | | clinical practice patterns of providers in order to identify 62 |
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100 | 100 | | trends that are outside the normal practice patterns of a 63 |
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101 | 101 | | provider's professional peers or the national guidelines of a 64 |
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102 | 102 | | provider's professional associati on. The vendor must be able to 65 |
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103 | 103 | | provide information and counseling to a provider whose practice 66 |
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104 | 104 | | patterns are outside the norms, in consultation with the agency, 67 |
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105 | 105 | | to improve patient care and reduce inappropriate utilization. 68 |
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106 | 106 | | The agency may mandate prior autho rization, drug therapy 69 |
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107 | 107 | | management, or disease management participation for certain 70 |
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108 | 108 | | populations of Medicaid beneficiaries, certain drug classes, or 71 |
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109 | 109 | | particular drugs to prevent fraud, abuse, overuse, and possible 72 |
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110 | 110 | | dangerous drug interactions. The Pharmaceutic al and Therapeutics 73 |
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111 | 111 | | Committee shall make recommendations to the agency on drugs for 74 |
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112 | 112 | | which prior authorization is required. The agency shall inform 75 |
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121 | 121 | | 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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122 | 122 | | |
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123 | 123 | | |
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125 | 125 | | the Pharmaceutical and Therapeutics Committee of its decisions 76 |
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126 | 126 | | regarding drugs subject to prior authorization . The agency is 77 |
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127 | 127 | | authorized to limit the entities it contracts with or enrolls as 78 |
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128 | 128 | | Medicaid providers by developing a provider network through 79 |
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129 | 129 | | provider credentialing. The agency may competitively bid single -80 |
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130 | 130 | | source-provider contracts if procurement of goods o r services 81 |
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131 | 131 | | results in demonstrated cost savings to the state without 82 |
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132 | 132 | | limiting access to care. The agency may limit its network based 83 |
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133 | 133 | | on the assessment of beneficiary access to care, provider 84 |
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134 | 134 | | availability, provider quality standards, time and distance 85 |
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135 | 135 | | standards for access to care, the cultural competence of the 86 |
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136 | 136 | | provider network, demographic characteristics of Medicaid 87 |
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137 | 137 | | beneficiaries, practice and provider -to-beneficiary standards, 88 |
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138 | 138 | | appointment wait times, beneficiary use of services, provider 89 |
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139 | 139 | | turnover, provider profiling, provider licensure history, 90 |
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140 | 140 | | previous program integrity investigations and findings, peer 91 |
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141 | 141 | | review, provider Medicaid policy and billing compliance records, 92 |
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142 | 142 | | clinical and medical record audits, and other factors. Providers 93 |
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143 | 143 | | are not entitled to enro llment in the Medicaid provider network. 94 |
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144 | 144 | | The agency shall determine instances in which allowing Medicaid 95 |
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145 | 145 | | beneficiaries to purchase durable medical equipment and other 96 |
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146 | 146 | | goods is less expensive to the Medicaid program than long -term 97 |
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147 | 147 | | rental of the equipment or goods. The agency may establish rules 98 |
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148 | 148 | | to facilitate purchases in lieu of long -term rentals in order to 99 |
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149 | 149 | | protect against fraud and abuse in the Medicaid program as 100 |
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158 | 158 | | 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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159 | 159 | | |
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160 | 160 | | |
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161 | 161 | | |
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162 | 162 | | defined in s. 409.913. The agency may seek federal waivers 101 |
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163 | 163 | | necessary to administer these poli cies. 102 |
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164 | 164 | | (5)(a) The agency shall implement a Medicaid prescribed -103 |
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165 | 165 | | drug spending-control program that includes the following 104 |
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166 | 166 | | components: 105 |
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167 | 167 | | 1. A Medicaid preferred drug list, which shall be a 106 |
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168 | 168 | | listing of cost-effective therapeutic options recommended by the 107 |
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169 | 169 | | Medicaid Pharmacy and Therapeutics Committee established 108 |
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170 | 170 | | pursuant to s. 409.91195 and adopted by the agency for each 109 |
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171 | 171 | | therapeutic class on the preferred drug list. At the discretion 110 |
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172 | 172 | | of the committee, and when feasible, the preferred drug list 111 |
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173 | 173 | | should include at least two products in a therapeutic class. The 112 |
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174 | 174 | | agency may post the preferred drug list and updates to the list 113 |
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175 | 175 | | on an Internet website without following the rulemaking 114 |
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176 | 176 | | procedures of chapter 120. Antiretroviral agents are excluded 115 |
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177 | 177 | | from the preferred drug list. The agency shall also limit the 116 |
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178 | 178 | | amount of a prescribed drug dispensed to no more than a 34 -day 117 |
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179 | 179 | | supply unless the drug products' sma llest marketed package is 118 |
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180 | 180 | | greater than a 34-day supply, or the drug is determined by the 119 |
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181 | 181 | | agency to be a maintenance drug in which case a 100 -day maximum 120 |
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182 | 182 | | supply may be authorized. The agency may seek any federal 121 |
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183 | 183 | | waivers necessary to implement these cost -control programs and 122 |
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184 | 184 | | to continue participation in the federal Medicaid rebate 123 |
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185 | 185 | | program, or alternatively to negotiate state -only manufacturer 124 |
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186 | 186 | | rebates. The agency may adopt rules to administer this 125 |
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195 | 195 | | 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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196 | 196 | | |
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197 | 197 | | |
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198 | 198 | | |
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199 | 199 | | subparagraph. The agency shall continue to provide unlimited 126 |
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200 | 200 | | contraceptive drugs and items. The agency must establish 127 |
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201 | 201 | | procedures to ensure that: 128 |
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202 | 202 | | a. There is a response to a request for prior 129 |
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203 | 203 | | authorization by telephone or other telecommunication device 130 |
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204 | 204 | | within 24 hours after receipt of a request for prior 131 |
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205 | 205 | | authorization; and 132 |
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206 | 206 | | b. A 72-hour supply of the drug prescribed is provided in 133 |
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207 | 207 | | an emergency or when the agency does not provide a response 134 |
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208 | 208 | | within 24 hours as required by sub -subparagraph a. 135 |
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209 | 209 | | 2. A provider of prescribed drugs is reimbursed in an 136 |
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210 | 210 | | amount not to exceed t he lesser of the actual acquisition cost 137 |
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211 | 211 | | based on the Centers for Medicare and Medicaid Services National 138 |
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212 | 212 | | Average Drug Acquisition Cost pricing files plus a professional 139 |
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213 | 213 | | dispensing fee, the wholesale acquisition cost plus a 140 |
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214 | 214 | | professional dispensing fee, the state maximum allowable cost 141 |
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215 | 215 | | plus a professional dispensing fee, or the usual and customary 142 |
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216 | 216 | | charge billed by the provider. 143 |
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217 | 217 | | 3. The agency shall develop and implement a process for 144 |
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218 | 218 | | managing the drug therapies of Medicaid recipients who are using 145 |
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219 | 219 | | significant numbers of prescribed drugs each month. The 146 |
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220 | 220 | | management process may include, but is not limited to, 147 |
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221 | 221 | | comprehensive, physician -directed medical-record reviews, claims 148 |
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222 | 222 | | analyses, and case evaluations to determine the medical 149 |
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223 | 223 | | necessity and appropriateness of a patient's treatment plan and 150 |
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232 | 232 | | 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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233 | 233 | | |
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234 | 234 | | |
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235 | 235 | | |
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236 | 236 | | drug therapies. The agency may contract with a private 151 |
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237 | 237 | | organization to provide drug -program-management services. The 152 |
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238 | 238 | | Medicaid drug benefit management program shall include 153 |
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239 | 239 | | initiatives to manage drug therapies for HIV/AIDS pat ients, 154 |
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240 | 240 | | patients using 20 or more unique prescriptions in a 180 -day 155 |
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241 | 241 | | period, and the top 1,000 patients in annual spending. The 156 |
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242 | 242 | | agency shall enroll any Medicaid recipient in the drug benefit 157 |
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243 | 243 | | management program if he or she meets the specifications of this 158 |
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244 | 244 | | provision and is not enrolled in a Medicaid health maintenance 159 |
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245 | 245 | | organization. 160 |
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246 | 246 | | 4. The agency may limit the size of its pharmacy network 161 |
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247 | 247 | | based on need, competitive bidding, price negotiations, 162 |
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248 | 248 | | credentialing, or similar criteria. The agency shall give 163 |
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249 | 249 | | special consideration to rural areas in determining the size and 164 |
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250 | 250 | | location of pharmacies included in the Medicaid pharmacy 165 |
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251 | 251 | | network. A pharmacy credentialing process may include criteria 166 |
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252 | 252 | | such as a pharmacy's full -service status, location, size, 167 |
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253 | 253 | | patient educational p rograms, patient consultation, disease 168 |
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254 | 254 | | management services, and other characteristics. The agency may 169 |
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255 | 255 | | impose a moratorium on Medicaid pharmacy enrollment if it is 170 |
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256 | 256 | | determined that it has a sufficient number of Medicaid -171 |
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257 | 257 | | participating providers. The agency mu st allow dispensing 172 |
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258 | 258 | | practitioners to participate as a part of the Medicaid pharmacy 173 |
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259 | 259 | | network regardless of the practitioner's proximity to any other 174 |
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260 | 260 | | entity that is dispensing prescription drugs under the Medicaid 175 |
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269 | 269 | | 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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270 | 270 | | |
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271 | 271 | | |
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272 | 272 | | |
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273 | 273 | | program. A dispensing practitioner must meet all credentialing 176 |
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274 | 274 | | requirements applicable to his or her practice, as determined by 177 |
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275 | 275 | | the agency. 178 |
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276 | 276 | | 5. The agency shall develop and implement a program that 179 |
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277 | 277 | | requires Medicaid practitioners who issue written prescriptions 180 |
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278 | 278 | | for medicinal drugs to use a counterf eit-proof prescription pad 181 |
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279 | 279 | | for Medicaid prescriptions. The agency shall require the use of 182 |
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280 | 280 | | standardized counterfeit -proof prescription pads by prescribers 183 |
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281 | 281 | | who issue written prescriptions for Medicaid recipients. The 184 |
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282 | 282 | | agency may implement the program in targ eted geographic areas or 185 |
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283 | 283 | | statewide. 186 |
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284 | 284 | | 6. The agency may enter into arrangements that require 187 |
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285 | 285 | | manufacturers of generic drugs prescribed to Medicaid recipients 188 |
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286 | 286 | | to provide rebates of at least 15.1 percent of the average 189 |
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287 | 287 | | manufacturer price for the manufacturer 's generic products. 190 |
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288 | 288 | | These arrangements must shall require that if a generic -drug 191 |
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289 | 289 | | manufacturer pays federal rebates for Medicaid -reimbursed drugs 192 |
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290 | 290 | | at a level below 15.1 percent, the manufacturer must provide a 193 |
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291 | 291 | | supplemental rebate to the state in an amount n ecessary to 194 |
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292 | 292 | | achieve a 15.1-percent rebate level. 195 |
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293 | 293 | | 7. The agency may establish a preferred drug list as 196 |
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294 | 294 | | described in this subsection, and, pursuant to the establishment 197 |
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295 | 295 | | of such preferred drug list, negotiate supplemental rebates from 198 |
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296 | 296 | | manufacturers that are in addition to those required by Title 199 |
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297 | 297 | | XIX of the Social Security Act and at no less than 14 percent of 200 |
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298 | 298 | | |
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306 | 306 | | 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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307 | 307 | | |
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308 | 308 | | |
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309 | 309 | | |
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310 | 310 | | the average manufacturer price as defined in 42 U.S.C. s. 1936 201 |
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311 | 311 | | on the last day of a quarter unless the federal or supplemental 202 |
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312 | 312 | | rebate, or both, equals or exceeds 29 percent. There is no upper 203 |
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313 | 313 | | limit on the supplemental rebates the agency may negotiate. The 204 |
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314 | 314 | | agency may determine that specific products, brand -name or 205 |
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315 | 315 | | generic, are competitive at lower rebate percentages. Agreement 206 |
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316 | 316 | | to pay the minimum supplemen tal rebate percentage guarantees a 207 |
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317 | 317 | | manufacturer that the Medicaid Pharmaceutical and Therapeutics 208 |
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318 | 318 | | Committee will consider a product for inclusion on the preferred 209 |
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319 | 319 | | drug list. However, a pharmaceutical manufacturer is not 210 |
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320 | 320 | | guaranteed placement on the preferre d drug list by simply paying 211 |
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321 | 321 | | the minimum supplemental rebate. Agency decisions will be made 212 |
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322 | 322 | | on the clinical efficacy of a drug and recommendations of the 213 |
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323 | 323 | | Medicaid Pharmaceutical and Therapeutics Committee, as well as 214 |
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324 | 324 | | the price of competing products minus f ederal and state rebates. 215 |
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325 | 325 | | The agency may contract with an outside agency or contractor to 216 |
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326 | 326 | | conduct negotiations for supplemental rebates. For the purposes 217 |
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327 | 327 | | of this section, the term "supplemental rebates" means cash 218 |
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328 | 328 | | rebates. Value-added programs as a substit ution for supplemental 219 |
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329 | 329 | | rebates are prohibited. The agency may seek any federal waivers 220 |
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330 | 330 | | to implement this initiative. 221 |
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331 | 331 | | 8.a. The agency may implement a Medicaid behavioral drug 222 |
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332 | 332 | | management system. The agency may contract with a vendor that 223 |
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333 | 333 | | has experience in operating behavioral drug management systems 224 |
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334 | 334 | | to implement this program. The agency may seek federal waivers 225 |
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335 | 335 | | |
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343 | 343 | | 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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344 | 344 | | |
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345 | 345 | | |
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346 | 346 | | |
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347 | 347 | | to implement this program. 226 |
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348 | 348 | | b. The agency, in conjunction with the Department of 227 |
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349 | 349 | | Children and Families, may implement the Medicaid behavioral 228 |
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350 | 350 | | drug management system that is designed to improve the quality 229 |
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351 | 351 | | of care and behavioral health prescribing practices based on 230 |
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352 | 352 | | best practice guidelines, improve patient adherence to 231 |
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353 | 353 | | medication plans, reduce clinical risk, and lower prescribed 232 |
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354 | 354 | | drug costs and the ra te of inappropriate spending on Medicaid 233 |
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355 | 355 | | behavioral drugs. The program may include the following 234 |
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356 | 356 | | elements: 235 |
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357 | 357 | | (I) Provide for the development and adoption of best 236 |
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358 | 358 | | practice guidelines for behavioral health -related drugs such as 237 |
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359 | 359 | | antipsychotics, antidepressant s, and medications for treating 238 |
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360 | 360 | | bipolar disorders and other behavioral conditions; translate 239 |
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361 | 361 | | them into practice; review behavioral health prescribers and 240 |
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362 | 362 | | compare their prescribing patterns to a number of indicators 241 |
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363 | 363 | | that are based on national standards; and determine deviations 242 |
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364 | 364 | | from best practice guidelines. 243 |
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365 | 365 | | (II) Implement processes for providing feedback to and 244 |
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366 | 366 | | educating prescribers using best practice educational materials 245 |
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367 | 367 | | and peer-to-peer consultation. 246 |
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368 | 368 | | (III) Assess Medicaid beneficiaries who are outli ers in 247 |
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369 | 369 | | their use of behavioral health drugs with regard to the numbers 248 |
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370 | 370 | | and types of drugs taken, drug dosages, combination drug 249 |
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371 | 371 | | therapies, and other indicators of improper use of behavioral 250 |
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381 | 381 | | |
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382 | 382 | | |
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383 | 383 | | |
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384 | 384 | | health drugs. 251 |
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385 | 385 | | (IV) Alert prescribers to patients who fail to ref ill 252 |
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386 | 386 | | prescriptions in a timely fashion, are prescribed multiple same -253 |
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387 | 387 | | class behavioral health drugs, and may have other potential 254 |
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388 | 388 | | medication problems. 255 |
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389 | 389 | | (V) Track spending trends for behavioral health drugs and 256 |
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390 | 390 | | deviation from best practice guidelines. 257 |
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391 | 391 | | (VI) Use educational and technological approaches to 258 |
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392 | 392 | | promote best practices, educate consumers, and train prescribers 259 |
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393 | 393 | | in the use of practice guidelines. 260 |
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394 | 394 | | (VII) Disseminate electronic and published materials. 261 |
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395 | 395 | | (VIII) Hold statewide and regional conferences. 262 |
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396 | 396 | | (IX) Implement a disease management program with a model 263 |
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397 | 397 | | quality-based medication component for severely mentally ill 264 |
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398 | 398 | | individuals and emotionally disturbed children who are high 265 |
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399 | 399 | | users of care. 266 |
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400 | 400 | | 9. The agency shall implement a Medicaid prescription drug 267 |
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401 | 401 | | management system. 268 |
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402 | 402 | | a. The agency may contract with a vendor that has 269 |
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403 | 403 | | experience in operating prescription drug management systems in 270 |
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404 | 404 | | order to implement this system. Any management system that is 271 |
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405 | 405 | | implemented in accordance with this subparagraph must rely o n 272 |
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406 | 406 | | cooperation between physicians and pharmacists to determine 273 |
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407 | 407 | | appropriate practice patterns and clinical guidelines to improve 274 |
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408 | 408 | | the prescribing, dispensing, and use of drugs in the Medicaid 275 |
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417 | 417 | | 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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418 | 418 | | |
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419 | 419 | | |
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420 | 420 | | |
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421 | 421 | | program. The agency may seek federal waivers to implement this 276 |
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422 | 422 | | program. 277 |
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423 | 423 | | b. The drug management system must be designed to improve 278 |
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424 | 424 | | the quality of care and prescribing practices based on best 279 |
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425 | 425 | | practice guidelines, improve patient adherence to medication 280 |
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426 | 426 | | plans, reduce clinical risk, and lower prescribed drug costs and 281 |
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427 | 427 | | the rate of inappropriate spending on Medicaid prescription 282 |
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428 | 428 | | drugs. The program must: 283 |
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429 | 429 | | (I) Provide for the adoption of best practice guidelines 284 |
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430 | 430 | | for the prescribing and use of drugs in the Medicaid program, 285 |
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431 | 431 | | including translating best practice guidelines into pra ctice; 286 |
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432 | 432 | | reviewing prescriber patterns and comparing them to indicators 287 |
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433 | 433 | | that are based on national standards and practice patterns of 288 |
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434 | 434 | | clinical peers in their community, statewide, and nationally; 289 |
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435 | 435 | | and determine deviations from best practice guidelines. 290 |
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436 | 436 | | (II) Implement processes for providing feedback to and 291 |
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437 | 437 | | educating prescribers using best practice educational materials 292 |
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438 | 438 | | and peer-to-peer consultation. 293 |
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439 | 439 | | (III) Assess Medicaid recipients who are outliers in their 294 |
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440 | 440 | | use of a single or multiple prescription drugs wi th regard to 295 |
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441 | 441 | | the numbers and types of drugs taken, drug dosages, combination 296 |
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442 | 442 | | drug therapies, and other indicators of improper use of 297 |
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443 | 443 | | prescription drugs. 298 |
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444 | 444 | | (IV) Alert prescribers to recipients who fail to refill 299 |
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445 | 445 | | prescriptions in a timely fashion, are prescr ibed multiple drugs 300 |
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455 | 455 | | |
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457 | 457 | | |
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458 | 458 | | that may be redundant or contraindicated, or may have other 301 |
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459 | 459 | | potential medication problems. 302 |
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460 | 460 | | 10. The agency may contract for drug rebate 303 |
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461 | 461 | | administration, including, but not limited to, calculating 304 |
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462 | 462 | | rebate amounts, invoicing manufacturers, negotiating disputes 305 |
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463 | 463 | | with manufacturers, and maintaining a database of rebate 306 |
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464 | 464 | | collections. 307 |
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465 | 465 | | 11. The agency may specify the preferred daily dosing form 308 |
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466 | 466 | | or strength for the purpose of promoting best practices with 309 |
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467 | 467 | | regard to the prescribing of certain drugs as specified in the 310 |
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468 | 468 | | General Appropriations Act and ensuring cost -effective 311 |
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469 | 469 | | prescribing practices. 312 |
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470 | 470 | | 12. The agency may require prior authorization for 313 |
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471 | 471 | | Medicaid-covered prescribed drugs. The agency may prior -314 |
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472 | 472 | | authorize the use of a product: 315 |
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473 | 473 | | a. For an indication not approved in labeling; 316 |
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474 | 474 | | b. To comply with certain clinical guidelines; or 317 |
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475 | 475 | | c. If the product has the potential for overuse, misuse, 318 |
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476 | 476 | | or abuse. 319 |
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477 | 477 | | 320 |
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478 | 478 | | The agency may require the prescribing professional to provide 321 |
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479 | 479 | | information about the rationale and su pporting medical evidence 322 |
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480 | 480 | | for the use of a drug. The agency shall post prior 323 |
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481 | 481 | | authorization, step-edit criteria and protocol, and updates to 324 |
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482 | 482 | | the list of drugs that are subject to prior authorization on the 325 |
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491 | 491 | | 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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492 | 492 | | |
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493 | 493 | | |
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494 | 494 | | |
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495 | 495 | | agency's Internet website within 21 days after the prior 326 |
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496 | 496 | | authorization and step -edit criteria and protocol and updates 327 |
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497 | 497 | | are approved by the agency. For purposes of this subparagraph, 328 |
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498 | 498 | | the term "step-edit" means an automatic electronic review of 329 |
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499 | 499 | | certain medications subject to prior authorization. 330 |
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500 | 500 | | 13. The agency, in conjunction with the Pharmaceutical and 331 |
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501 | 501 | | Therapeutics Committee, may require age -related prior 332 |
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502 | 502 | | authorizations for certain prescribed drugs. The agency may 333 |
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503 | 503 | | preauthorize the use of a drug for a recipient who may not meet 334 |
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504 | 504 | | the age requirement or may ex ceed the length of therapy for use 335 |
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505 | 505 | | of this product as recommended by the manufacturer and approved 336 |
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506 | 506 | | by the Food and Drug Administration. Prior authorization may 337 |
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507 | 507 | | require the prescribing professional to provide information 338 |
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508 | 508 | | about the rationale and supporting m edical evidence for the use 339 |
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509 | 509 | | of a drug. 340 |
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510 | 510 | | 14. The agency shall implement a step -therapy prior 341 |
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511 | 511 | | authorization approval process for medications excluded from the 342 |
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512 | 512 | | preferred drug list. Medications listed on the preferred drug 343 |
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513 | 513 | | list must be used within the previou s 12 months before the 344 |
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514 | 514 | | alternative medications that are not listed. The step -therapy 345 |
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515 | 515 | | prior authorization may require the prescriber to use the 346 |
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516 | 516 | | medications of a similar drug class or for a similar medical 347 |
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517 | 517 | | indication unless contraindicated in the Food and Dr ug 348 |
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518 | 518 | | Administration labeling. The trial period between the specified 349 |
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519 | 519 | | steps may vary according to the medical indication. The step -350 |
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529 | 529 | | |
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531 | 531 | | |
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532 | 532 | | therapy approval process must shall be developed in accordance 351 |
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533 | 533 | | with the committee as stated in s. 409.91195(7) and (8). A drug 352 |
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534 | 534 | | product may be approved or, in the case of a drug product for 353 |
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535 | 535 | | the treatment of a serious mental illness, must be approved 354 |
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536 | 536 | | without meeting the step -therapy prior authorization criteria if 355 |
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537 | 537 | | the prescribing physician provides the agency with additional 356 |
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538 | 538 | | written medical or clinical documentation that the product is 357 |
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539 | 539 | | medically necessary because: 358 |
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540 | 540 | | a. There is not a drug on the preferred drug list to treat 359 |
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541 | 541 | | the disease or medical condition which is an acceptable clinical 360 |
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542 | 542 | | alternative; 361 |
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543 | 543 | | b. The alternatives have been in effective in the treatment 362 |
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544 | 544 | | of the beneficiary's disease; 363 |
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545 | 545 | | c. The drug product or medication of a similar drug class 364 |
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546 | 546 | | is prescribed for the treatment of a serious mental illness 365 |
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547 | 547 | | schizophrenia or schizotypal or delusional disorders ; prior 366 |
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548 | 548 | | authorization has been granted previously for the prescribed 367 |
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549 | 549 | | drug; and the medication was dispensed to the patient during the 368 |
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550 | 550 | | previous 12 months; or 369 |
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551 | 551 | | d. Based on historical evidence and known characteristics 370 |
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552 | 552 | | of the patient and the drug, the drug is likely to be 371 |
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553 | 553 | | ineffective, or the number of doses have been ineffective. 372 |
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554 | 554 | | 373 |
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555 | 555 | | The agency shall work with the physician to determine the best 374 |
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556 | 556 | | alternative for the patient. The agency may adopt rules waiving 375 |
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566 | 566 | | |
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568 | 568 | | |
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569 | 569 | | the requirements for written clinical documentation for specific 376 |
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570 | 570 | | drugs in limited clinical situations. 377 |
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571 | 571 | | 15. The agency shall implement a return and reuse program 378 |
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572 | 572 | | for drugs dispensed by pharmacies to institutional recipients, 379 |
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573 | 573 | | which includes payment of a $5 restocking fee for the 380 |
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574 | 574 | | implementation and operation of the program. The return a nd 381 |
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575 | 575 | | reuse program shall be implemented electronically and in a 382 |
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576 | 576 | | manner that promotes efficiency. The program must permit a 383 |
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577 | 577 | | pharmacy to exclude drugs from the program if it is not 384 |
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578 | 578 | | practical or cost-effective for the drug to be included and must 385 |
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579 | 579 | | provide for the return to inventory of drugs that cannot be 386 |
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580 | 580 | | credited or returned in a cost -effective manner. The agency 387 |
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581 | 581 | | shall determine if the program has reduced the amount of 388 |
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582 | 582 | | Medicaid prescription drugs which are destroyed on an annual 389 |
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583 | 583 | | basis and if there are additiona l ways to ensure more 390 |
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584 | 584 | | prescription drugs are not destroyed which could safely be 391 |
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585 | 585 | | reused. 392 |
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586 | 586 | | Section 3. Paragraph (a) of subsection (20) of section 393 |
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587 | 587 | | 409.910, Florida Statutes, is amended to read: 394 |
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588 | 588 | | 409.910 Responsibility for payments on behalf of Medicaid -395 |
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589 | 589 | | eligible persons when other parties are liable. — 396 |
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590 | 590 | | (20)(a) Entities providing health insurance as defined in 397 |
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591 | 591 | | s. 624.603, health maintenance organizations and prepaid health 398 |
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592 | 592 | | clinics as defined in chapter 641, and, on behalf of their 399 |
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593 | 593 | | clients, third-party administrators, pharmacy benefits managers, 400 |
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603 | 603 | | |
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604 | 604 | | |
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605 | 605 | | |
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606 | 606 | | and any other third parties, as defined in s. 409.901 s. 401 |
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607 | 607 | | 409.901(27), which are legally responsible for payment of a 402 |
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608 | 608 | | claim for a health care item or service as a condition of doing 403 |
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609 | 609 | | business in the state or providing coverage to residents of the 404 |
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610 | 610 | | this state, shall provide such records and information as are 405 |
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611 | 611 | | necessary to accomplish the purpose of this section, unless such 406 |
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612 | 612 | | requirement results in an unreasonable burden. 407 |
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613 | 613 | | Section 4. The Agency for Health Care Administrat ion is 408 |
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614 | 614 | | directed to include the rate impact of this act in the Medicaid 409 |
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615 | 615 | | managed medical assistance program and long -term care managed 410 |
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616 | 616 | | care program rates that become effective on October 1, 2024. 411 |
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617 | 617 | | Section 5. This act shall take effect October 1, 2024. 412 |
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