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9 | 9 | | Page 1 of 12 |
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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 pharmacies and 2 |
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16 | 16 | | prescription drugs under insurance and pharmacy 3 |
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17 | 17 | | benefit managers policies; amending s. 624.3161, F.S.; 4 |
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18 | 18 | | requiring the Office of Insurance Regulation to 5 |
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19 | 19 | | examine pharmacy benefit managers to ascertain 6 |
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20 | 20 | | compliance with specified laws; conforming a provision 7 |
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21 | 21 | | to changes made by the act; amending s. 624.490, F.S.; 8 |
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22 | 22 | | requiring the office to suspend or revoke 9 |
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23 | 23 | | registrations for pharmacy benefit managers and impose 10 |
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24 | 24 | | fines and civil penalties for certain violations; 11 |
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25 | 25 | | providing fines and civil penalties; providing that 12 |
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26 | 26 | | such violations are unfair methods of competition or 13 |
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27 | 27 | | unfair or deceptive acts or practices; providing that 14 |
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28 | 28 | | such violations are subject to certain actions, 15 |
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29 | 29 | | remedies, and penalties; providing applicability; 16 |
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30 | 30 | | creating s. 624.4901, F.S.; providing purpose; 17 |
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31 | 31 | | providing definitions; requiring pharmacy benefit 18 |
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32 | 32 | | managers to establish pharmacy benefit networks for a 19 |
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33 | 33 | | specified purpose; requiring pharmacy benefit managers 20 |
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34 | 34 | | to have standard contracts with pharmacies; providing 21 |
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35 | 35 | | requirements for such contracts' terms and conditions; 22 |
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36 | 36 | | requiring pharmacy benefit managers to provide copies 23 |
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37 | 37 | | of such standard contracts within a specified 24 |
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38 | 38 | | timeframe to requesting pharmacies and pharmacists; 25 |
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40 | 40 | | HB 203 2023 |
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46 | 46 | | Page 2 of 12 |
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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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49 | 49 | | |
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50 | 50 | | |
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51 | 51 | | prohibiting pharmacy benefit managers from denying 26 |
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52 | 52 | | pharmacies and pharmacists in the state the right to 27 |
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53 | 53 | | participate as contract providers under certain 28 |
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54 | 54 | | circumstances; providing construction; authorizing 29 |
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55 | 55 | | certain persons and entities to bring actions and 30 |
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56 | 56 | | injunctive relief under certain circumstances; 31 |
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57 | 57 | | authorizing the Department of Financial Services to 32 |
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58 | 58 | | adopt rules; creating s. 624.4902, F.S.; providing 33 |
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59 | 59 | | purpose; providing definitions; prohibiting pharmacy 34 |
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60 | 60 | | benefit managers from engaging in certain acts against 35 |
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61 | 61 | | patients and covered individuals; providing that such 36 |
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62 | 62 | | acts are unfair methods of competition or unfair or 37 |
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63 | 63 | | deceptive acts or practices; providing that such acts 38 |
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64 | 64 | | are subject to certain actions, remedies, and 39 |
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65 | 65 | | penalties; authorizing the department to adopt rules; 40 |
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66 | 66 | | creating s. 627.42398, F.S.; providing definitions; 41 |
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67 | 67 | | prohibiting health insurers and pharmacy benefit 42 |
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68 | 68 | | managers from engaging in certain acts relating to 43 |
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69 | 69 | | covered clinician-administered drugs; providing that 44 |
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70 | 70 | | such acts constitute unfair methods of competition or 45 |
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71 | 71 | | unfair or deceptive acts or practices and are subje ct 46 |
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72 | 72 | | to certain actions, remedies, and penalties; providing 47 |
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73 | 73 | | an effective date. 48 |
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74 | 74 | | 49 |
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75 | 75 | | Be It Enacted by the Legislature of the State of Florida: 50 |
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76 | 76 | | |
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77 | 77 | | HB 203 2023 |
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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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88 | 88 | | 51 |
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89 | 89 | | Section 1. Subsections (1) and (3) of section 624.3161, 52 |
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90 | 90 | | Florida Statutes, are amended to read: 53 |
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91 | 91 | | 624.3161 Market conduct examinations. — 54 |
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92 | 92 | | (1) As often as it deems necessary, the office shall 55 |
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93 | 93 | | examine each pharmacy benefit manager as defined in s. 624.490, 56 |
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94 | 94 | | each licensed rating organization, each advisory organization, 57 |
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95 | 95 | | each group, association, carrier, as defined in s . 440.02, or 58 |
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96 | 96 | | other organization of insurers which engages in joint 59 |
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97 | 97 | | underwriting or joint reinsurance, and each authorized insurer 60 |
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98 | 98 | | transacting in this state any class of insurance to which the 61 |
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99 | 99 | | provisions of chapter 627 are applicable. The examination shall 62 |
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100 | 100 | | be for the purpose of ascertaining compliance by the person 63 |
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101 | 101 | | examined with the applicable provisions of chapters 440, 624, 64 |
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102 | 102 | | 626, 627, and 635. 65 |
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103 | 103 | | (3) The examination may be conducted by an independent 66 |
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104 | 104 | | professional examiner under contract to the office, in whi ch 67 |
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105 | 105 | | case payment shall be made directly to the contracted examiner 68 |
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106 | 106 | | by the entity insurer examined in accordance with the rates and 69 |
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107 | 107 | | terms agreed to by the office and the examiner. 70 |
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108 | 108 | | Section 2. Subsections (6) and (7) of section 624.490, 71 |
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109 | 109 | | Florida Statutes, are renumbered as subsections (8) and (9), 72 |
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110 | 110 | | respectively, and new subsections (6) and (7) are added to that 73 |
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111 | 111 | | section, to read: 74 |
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112 | 112 | | 624.490 Registration of pharmacy benefit managers. — 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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125 | 125 | | (6)(a) The office may suspend or revoke a pharmacy benefit 76 |
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126 | 126 | | manager's registration or impose a fine or civil penalty if it 77 |
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127 | 127 | | finds that the pharmacy benefit manager has violated s. 78 |
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128 | 128 | | 624.4901, s. 624.4902, s. 624.491, s. 627.42398, s. 627.6131, s. 79 |
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129 | 129 | | 627.64741, s. 627.6572, s. 641.314, or s. 641.3155. The fine or 80 |
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130 | 130 | | civil penalty shall be in the amount of $10,000 for each 81 |
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131 | 131 | | violation, which shall accrue for each day the pharmacy benefit 82 |
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132 | 132 | | manager is in violation of the law. 83 |
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133 | 133 | | (b) The violation of any section enumerated in paragraph 84 |
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134 | 134 | | (a) constitutes an unfair method of competition or an unfair or 85 |
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135 | 135 | | deceptive act or practice, subject to actions, remedies, and 86 |
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136 | 136 | | penalties provided by the Florida Deceptive and Unfair Trade 87 |
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137 | 137 | | Practices Act and consumer protection laws. 88 |
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138 | 138 | | (7) Subsection (6) applies to contracts between a pharmacy 89 |
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139 | 139 | | benefit manager and a pharmacy that participates in a retail 90 |
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140 | 140 | | pharmacy network of the pharmacy benefit manager. 91 |
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141 | 141 | | Section 3. Section 624.4901, Florida Statutes, is created 92 |
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142 | 142 | | to read: 93 |
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143 | 143 | | 624.4901 Pharmacy benefit manager contracts with 94 |
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144 | 144 | | pharmacies.— 95 |
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145 | 145 | | (1) The purpose of this section is to give patients 96 |
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146 | 146 | | convenient access to affordable prescription drugs through a 97 |
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147 | 147 | | pharmacy of their choice. 98 |
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148 | 148 | | (2) As used in this section, the term: 99 |
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149 | 149 | | (a) "Affiliate" means a pharmacy in which a pharmacy 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 | | benefit manager, directly or indirectly, has an investment or 101 |
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163 | 163 | | ownership interest or shares common ownership. 102 |
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164 | 164 | | (b) "Pharmacy" means a pharmacy licensed under chapter 103 |
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165 | 165 | | 465, a nonresident pharmacy registered under s. 465.0156, or a 104 |
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166 | 166 | | nonresident pharmacy or outsourcing facility holding an active 105 |
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167 | 167 | | permit pursuant to s. 4 65.0158 to dispense drugs to patients 106 |
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168 | 168 | | located in this state. 107 |
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169 | 169 | | (c) "Pharmacy benefit manager" has the same meaning as in 108 |
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170 | 170 | | s. 624.490(1). 109 |
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171 | 171 | | (3) A pharmacy benefit manager shall establish a 110 |
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172 | 172 | | reasonably adequate and accessible pharmacy benefit network to 111 |
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173 | 173 | | provide patients with convenient access to prescription drugs 112 |
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174 | 174 | | through pharmacies that are located within a reasonable distance 113 |
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175 | 175 | | from a patient's residence. 114 |
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176 | 176 | | (4) A pharmacy benefit manager shall have a standard 115 |
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177 | 177 | | contract with reasonable and relevant terms and cond itions of 116 |
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178 | 178 | | participation in the pharmacy benefit network, whereby any 117 |
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179 | 179 | | willing pharmacy may participate as a network pharmacy. Terms 118 |
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180 | 180 | | and conditions must include provisions reasonable and relevant 119 |
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181 | 181 | | to unique pharmacy, pharmacy business, and pharmacy service 120 |
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182 | 182 | | models. 121 |
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183 | 183 | | (5) A pharmacy benefit manager shall provide a copy of the 122 |
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184 | 184 | | standard contract to a requesting pharmacy or pharmacist within 123 |
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185 | 185 | | 7 business days after receiving such a request from the pharmacy 124 |
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186 | 186 | | or pharmacist. 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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197 | 197 | | |
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198 | 198 | | |
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199 | 199 | | (6) If a pharmacy benefit manager's affilia te participates 126 |
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200 | 200 | | in the pharmacy benefit network, the pharmacy benefit manager 127 |
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201 | 201 | | may not deny another pharmacy or pharmacist in this state the 128 |
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202 | 202 | | right to participate as a contract provider under the policy or 129 |
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203 | 203 | | plan, provided that the pharmacy or pharmacist agree s to: 130 |
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204 | 204 | | (a) Provide pharmaceutical services that meet all 131 |
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205 | 205 | | reasonable and relevant terms and conditions. 132 |
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206 | 206 | | (b) Include the same administrative, financial, and 133 |
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207 | 207 | | professional conditions that apply to pharmacy and pharmacists 134 |
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208 | 208 | | that have been designated as provid ers under the policy or plan. 135 |
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209 | 209 | | (7) The decision of a pharmacy or pharmacist to accept a 136 |
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210 | 210 | | contract with the pharmacy benefit manager is not admissible 137 |
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211 | 211 | | proof that the contract is reasonable and relevant. 138 |
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212 | 212 | | (8) Without regard to any other remedy or relief to which 139 |
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213 | 213 | | a pharmacy is entitled, a pharmacy, a pharmacist, or a person, 140 |
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214 | 214 | | firm, corporation, association, entity, or any agent or employee 141 |
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215 | 215 | | of a pharmacy or pharmacist which is aggrieved by a violation of 142 |
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216 | 216 | | this section may bring an action to recover damages, plus 143 |
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217 | 217 | | attorney fees and costs, and injunctive relief. 144 |
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218 | 218 | | (9) The department may adopt rules to implement this 145 |
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219 | 219 | | section. 146 |
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220 | 220 | | Section 4. Section 624.4902, Florida Statutes, is created 147 |
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221 | 221 | | to read: 148 |
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222 | 222 | | 624.4902 Pharmacy benefit managers' prohibited acts. — 149 |
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223 | 223 | | (1) The purpose of this section is to protect patient 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 | | welfare by establishing minimum standards for patient access to 151 |
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237 | 237 | | a pharmacy provider and by prohibiting restrictions imposed by a 152 |
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238 | 238 | | pharmacy benefit manager on a patient's right to choose a 153 |
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239 | 239 | | pharmacy. 154 |
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240 | 240 | | (2) As used in this section, the term: 155 |
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241 | 241 | | (a) "Affiliate" means a pharmacy in which a pharmacy 156 |
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242 | 242 | | benefit manager, directly or indirectly, has an investment or 157 |
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243 | 243 | | ownership interest or shares common ownership. As used in this 158 |
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244 | 244 | | paragraph, the term "pharmacy" has the same meaning as in s. 159 |
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245 | 245 | | 624.4901(2). 160 |
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246 | 246 | | (b) "Pharmacy benefit manager" has the same meaning as in 161 |
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247 | 247 | | s. 624.490(1). 162 |
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248 | 248 | | (c) "Wholesale acquisition cost" means the amount that a 163 |
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249 | 249 | | pharmaceutical wholesaler charges for a pharmaceutical product 164 |
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250 | 250 | | as listed on the pharmacy's billing inv oice. 165 |
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251 | 251 | | (3) A pharmacy benefit manager may not: 166 |
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252 | 252 | | (a) Offer, incentivize, or implement a plan design that 167 |
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253 | 253 | | requires a patient or covered individual to use an affiliate; 168 |
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254 | 254 | | (b) Refer or incentivize a patient or covered individual 169 |
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255 | 255 | | to use an affiliate or any ph armacy in which the pharmacy 170 |
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256 | 256 | | benefit manager has any direct or indirect financial interest or 171 |
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257 | 257 | | ownership; 172 |
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258 | 258 | | (c) Restrict the choice of a patient or covered individual 173 |
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259 | 259 | | of an in-network provider for prescription drugs; 174 |
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260 | 260 | | (d) Reimburse a pharmacy or pharmacist in this state an 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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273 | 273 | | amount less than the amount that the pharmacy benefit manager 176 |
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274 | 274 | | reimburses an affiliate for providing the same drug products, 177 |
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275 | 275 | | drug product ingredients, or pharmacist services; or 178 |
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276 | 276 | | (e) Reimburse a pharmacy or pharmacist in this state for a 179 |
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277 | 277 | | drug product, drug product ingredient, or pharmacist services an 180 |
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278 | 278 | | amount less than the national average drug acquisition cost, or, 181 |
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279 | 279 | | if the national average drug acquisition cost is unavailable, 182 |
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280 | 280 | | the wholesale acquisition cost. 183 |
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281 | 281 | | (4) The commission of any act prohibited under subsection 184 |
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282 | 282 | | (3) constitutes an unfair method of competition or an unfair or 185 |
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283 | 283 | | deceptive act or practice, subject to actions, remedies, and 186 |
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284 | 284 | | penalties provided by the Florida Deceptive and Unfair Trade 187 |
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285 | 285 | | Practices Act and consumer protection laws . 188 |
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286 | 286 | | (5) The department may adopt rules necessary to implement 189 |
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287 | 287 | | this section. 190 |
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288 | 288 | | Section 5. Section 627.42398, Florida Statutes, is created 191 |
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289 | 289 | | to read: 192 |
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290 | 290 | | 627.42398 Coverage of clinician -administered drugs by 193 |
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291 | 291 | | health insurers and pharmacy benefit managers. — 194 |
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292 | 292 | | (1) As used in this section, the term: 195 |
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293 | 293 | | (a) "Clinician-administered drug" means a prescription 196 |
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294 | 294 | | drug other than a vaccine which: 197 |
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295 | 295 | | 1. Has not been approved by the United States Food and 198 |
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296 | 296 | | Drug Administration as a self -administered drug or self -199 |
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297 | 297 | | administered biologic, or cannot reasonably be administered by 200 |
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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 patient to whom the drug is prescribed or by an individual 201 |
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311 | 311 | | other than a health care provider. 202 |
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312 | 312 | | 2. Is typically administered in a physician's office, 203 |
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313 | 313 | | hospital, outpatient infusion center, or other clinical setting. 204 |
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314 | 314 | | (b) "Health care provider" means a health care 205 |
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315 | 315 | | professional, health care facility, or entity licensed or 206 |
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316 | 316 | | certified to provide health care services in this state which 207 |
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317 | 317 | | meets the criteria established by the Department of Health. 208 |
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318 | 318 | | (c) "Insurer" means an insurer as defined in s. 624.03 209 |
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319 | 319 | | which provides health insurance coverage, a multiple -employer 210 |
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320 | 320 | | welfare arrangement as def ined in s. 624.437(1), self -insurance 211 |
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321 | 321 | | as defined in s. 624.031, a prepaid limited health service 212 |
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322 | 322 | | organization as defined in s. 636.003(7), a health maintenance 213 |
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323 | 323 | | organization as defined in s. 641.19(12), a prepaid health 214 |
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324 | 324 | | clinic as defined in s. 641.402, a fr aternal benefit society as 215 |
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325 | 325 | | defined in s. 632.601 which provides health care benefits, or 216 |
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326 | 326 | | any health care arrangement that assumes some risk. 217 |
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327 | 327 | | (d) "Participating provider" means a health care provider 218 |
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328 | 328 | | that participates in the network of an insurer or pharm acy 219 |
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329 | 329 | | benefit manager. 220 |
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330 | 330 | | (e) "Pharmacy benefit manager" has the same meaning as in 221 |
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331 | 331 | | s. 624.490(1). 222 |
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332 | 332 | | (f) "White bagging" means the policy of an insurer or 223 |
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333 | 333 | | pharmacy benefit manager which requires a prescription drug to 224 |
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334 | 334 | | be: 225 |
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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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346 | 346 | | |
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347 | 347 | | 1. Dispensed by a specialty pharmac y selected by the 226 |
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348 | 348 | | insurer or pharmacy benefit manager. 227 |
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349 | 349 | | 2. Transported to a health care provider for 228 |
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350 | 350 | | administration to a patient. 229 |
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351 | 351 | | 230 |
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352 | 352 | | As used in this paragraph, the term "specialty pharmacy" means a 231 |
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353 | 353 | | pharmacy that focuses on high -cost medications and personal ized 232 |
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354 | 354 | | support for patients with chronic or complex conditions. 233 |
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355 | 355 | | (2) An insurer or pharmacy benefit manager that covers a 234 |
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356 | 356 | | clinician-administered drug may not: 235 |
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357 | 357 | | (a) Condition, deny, or reduce payment to a participating 236 |
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358 | 358 | | provider for providing the covered cli nician-administered drug 237 |
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359 | 359 | | and related services to an insured if all the criteria for the 238 |
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360 | 360 | | medical necessity for providing and administering the clinician -239 |
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361 | 361 | | administered drug are met, regardless of whether the clinician -240 |
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362 | 362 | | administered drug is obtained from a phar macy selected by the 241 |
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363 | 363 | | insurer or pharmacy benefit manager. For the purposes of this 242 |
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364 | 364 | | section, the location of receiving the clinician -administered 243 |
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365 | 365 | | drug may not be considered a medical necessity criterion. 244 |
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366 | 366 | | (b) Interfere with the insured's right to choose to obtain 245 |
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367 | 367 | | the covered clinician -administered drug from a participating 246 |
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368 | 368 | | provider or a pharmacy of choice, through any inducement, 247 |
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369 | 369 | | steering, or financial or other incentive offer. 248 |
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370 | 370 | | (c) Require the covered clinician -administered drug to be 249 |
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371 | 371 | | dispensed by a pharm acy selected by the insurer or pharmacy 250 |
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380 | 380 | | 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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381 | 381 | | |
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383 | 383 | | |
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384 | 384 | | benefit manager, including, but not limited to, through white 251 |
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385 | 385 | | bagging. 252 |
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386 | 386 | | (d) If the covered clinician -administered drug is not 253 |
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387 | 387 | | dispensed by a pharmacy selected by the insurer or pharmacy 254 |
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388 | 388 | | benefit manager: 255 |
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389 | 389 | | 1. Reimburse for the clinician -administered drug at a 256 |
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390 | 390 | | lesser amount than the amount that would otherwise be 257 |
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391 | 391 | | reimbursed; 258 |
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392 | 392 | | 2. Limit or exclude coverage or benefits for the 259 |
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393 | 393 | | clinician-administered drug; or 260 |
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394 | 394 | | 3. Require the insured to pay an additional fee, a higher 261 |
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395 | 395 | | copayment, a higher coinsurance, a second copayment, a second 262 |
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396 | 396 | | coinsurance, or any other form of an increased cost -sharing 263 |
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397 | 397 | | amount over the price paid for the clinician -administered drug 264 |
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398 | 398 | | dispensed by a pharmacy selected by the insurer or pharmacy 265 |
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399 | 399 | | benefit manager. 266 |
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400 | 400 | | (e) Require that the covered clinician -administered drug 267 |
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401 | 401 | | be administered using home infusion or be sent directly to a 268 |
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402 | 402 | | third party or to the insured for home infusion, unless the 269 |
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403 | 403 | | insured's treating physician determines that home infusion of 270 |
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404 | 404 | | the clinician-administered drug will not jeopardize the 271 |
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405 | 405 | | insured's health. 272 |
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406 | 406 | | (3) The commission of any act prohibited under subsection 273 |
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407 | 407 | | (2) constitutes an unfair method of competition or an unfair or 274 |
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408 | 408 | | deceptive act or practice, subject to actions, remedies, and 275 |
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409 | 409 | | |
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410 | 410 | | HB 203 2023 |
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411 | 411 | | |
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412 | 412 | | |
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413 | 413 | | |
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414 | 414 | | CODING: Words stricken are deletions; words underlined are additions. |
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415 | 415 | | hb0203-00 |
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416 | 416 | | Page 12 of 12 |
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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 | | penalties provided by the Florida Deceptive and Unfair Trade 276 |
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422 | 422 | | Practices Act and consumer protection laws. 277 |
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423 | 423 | | Section 6. This act shall take effect July 1, 2023. 278 |
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