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9 | 9 | | Page 1 of 13 |
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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 prescription drug coverage; 2 |
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16 | 16 | | creating s. 627.42394, F.S.; requiring individual and 3 |
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17 | 17 | | group health insurers to provide notice of 4 |
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18 | 18 | | prescription drug formulary changes within a certain 5 |
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19 | 19 | | timeframe to current and prospective insureds and the 6 |
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20 | 20 | | insureds' treating physicians; specifying requirements 7 |
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21 | 21 | | for the content of such notice and the manner in which 8 |
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22 | 22 | | it must be provided; specifying requirements for a 9 |
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23 | 23 | | notice of medical necessity submitted by the treating 10 |
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24 | 24 | | physician; authorizing insurers to provide cer tain 11 |
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25 | 25 | | means for submitting the notice of medical necessity; 12 |
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26 | 26 | | requiring the Financial Services Commission to adopt a 13 |
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27 | 27 | | certain form by rule by a specified date; specifying a 14 |
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28 | 28 | | coverage requirement and restrictions on coverage 15 |
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29 | 29 | | modification by insurers receiving a notice of medical 16 |
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30 | 30 | | necessity; providing construction and applicability; 17 |
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31 | 31 | | requiring insurers to maintain a record of formulary 18 |
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32 | 32 | | changes; requiring insurers to annually submit a 19 |
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33 | 33 | | specified report to the Office of Insurance Regulation 20 |
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34 | 34 | | by a specified date; requiri ng the office to annually 21 |
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35 | 35 | | compile certain data and prepare a report, make the 22 |
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36 | 36 | | report publicly accessible on its website, and submit 23 |
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37 | 37 | | the report to the Governor and the Legislature by a 24 |
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38 | 38 | | specified date; amending s. 627.6699, F.S.; requiring 25 |
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46 | 46 | | Page 2 of 13 |
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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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51 | 51 | | small employer carriers to comply with certain 26 |
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52 | 52 | | requirements for prescription drug formulary changes; 27 |
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53 | 53 | | amending s. 641.31, F.S.; providing an exception to 28 |
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54 | 54 | | requirements relating to changes in a health 29 |
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55 | 55 | | maintenance organization's group contract; requiring 30 |
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56 | 56 | | health maintenance orga nizations to provide notice of 31 |
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57 | 57 | | prescription drug formulary changes within a certain 32 |
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58 | 58 | | timeframe to current and prospective subscribers and 33 |
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59 | 59 | | the subscribers' treating physicians; specifying 34 |
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60 | 60 | | requirements for the content of such notice and the 35 |
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61 | 61 | | manner in which it must be provided; specifying 36 |
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62 | 62 | | requirements for a notice of medical necessity 37 |
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63 | 63 | | submitted by the treating physician; authorizing 38 |
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64 | 64 | | health maintenance organizations to provide certain 39 |
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65 | 65 | | means for submitting the notice of medical necessity; 40 |
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66 | 66 | | requiring the commission to adopt a certain form by 41 |
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67 | 67 | | rule by a specified date; specifying a coverage 42 |
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68 | 68 | | requirement and restrictions on coverage modification 43 |
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69 | 69 | | by health maintenance organizations receiving a notice 44 |
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70 | 70 | | of medical necessity; providing construction and 45 |
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71 | 71 | | applicability; requiri ng health maintenance 46 |
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72 | 72 | | organizations to maintain a record of formulary 47 |
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73 | 73 | | changes; requiring health maintenance organizations to 48 |
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74 | 74 | | annually submit a specified report to the office by a 49 |
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75 | 75 | | specified date; requiring the office to annually 50 |
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77 | 77 | | HB 1543 2024 |
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83 | 83 | | Page 3 of 13 |
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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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86 | 86 | | |
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87 | 87 | | |
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88 | 88 | | compile certain data and pre pare a report, make the 51 |
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89 | 89 | | report publicly accessible on its website, and submit 52 |
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90 | 90 | | the report to the Governor and the Legislature by a 53 |
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91 | 91 | | specified date; providing applicability; providing a 54 |
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92 | 92 | | declaration of important state interest; providing an 55 |
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93 | 93 | | effective date. 56 |
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94 | 94 | | 57 |
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95 | 95 | | Be It Enacted by the Legislature of the State of Florida: 58 |
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96 | 96 | | 59 |
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97 | 97 | | Section 1. Section 627.42394, Florida Statutes, is created 60 |
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98 | 98 | | to read: 61 |
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99 | 99 | | 627.42394 Health insurance policies; changes to 62 |
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100 | 100 | | prescription drug formularies; requirements. — 63 |
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101 | 101 | | (1) At least 60 days be fore the effective date of any 64 |
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102 | 102 | | change to a prescription drug formulary during a policy year, an 65 |
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103 | 103 | | insurer issuing individual or group health insurance policies in 66 |
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104 | 104 | | the state shall notify: 67 |
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105 | 105 | | (a) Current and prospective insureds of the change in the 68 |
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106 | 106 | | formulary in a readily accessible format on the insurer's 69 |
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107 | 107 | | website; and 70 |
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108 | 108 | | (b) Any insured currently receiving coverage for a 71 |
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109 | 109 | | prescription drug for which the formulary change modifies 72 |
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110 | 110 | | coverage and the insured's treating physician. Such notification 73 |
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111 | 111 | | must be sent electro nically and by first -class mail and must 74 |
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112 | 112 | | include information on the specific drugs involved and a 75 |
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120 | 120 | | Page 4 of 13 |
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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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124 | 124 | | |
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125 | 125 | | statement that the submission of a notice of medical necessity 76 |
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126 | 126 | | by the insured's treating physician to the insurer at least 30 77 |
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127 | 127 | | days before the effective date o f the formulary change will 78 |
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128 | 128 | | result in continuation of coverage at the existing level. 79 |
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129 | 129 | | (2) The notice provided by the treating physician to the 80 |
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130 | 130 | | insurer must include a completed one -page form in which the 81 |
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131 | 131 | | treating physician certifies to the insurer that th e 82 |
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132 | 132 | | prescription drug for the insured is medically necessary as 83 |
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133 | 133 | | defined in s. 627.732(2). The treating physician shall submit 84 |
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134 | 134 | | the notice electronically or by first -class mail. The insurer 85 |
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135 | 135 | | may provide the treating physician with access to an electronic 86 |
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136 | 136 | | portal through which the treating physician may electronically 87 |
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137 | 137 | | submit the notice. By January 1, 2025, the commission shall 88 |
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138 | 138 | | adopt by rule a form for the notice. 89 |
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139 | 139 | | (3) If the treating physician certifies to the insurer in 90 |
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140 | 140 | | accordance with subsection (2) that the pr escription drug is 91 |
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141 | 141 | | medically necessary for the insured, the insurer: 92 |
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142 | 142 | | (a) Must authorize coverage for the prescribed drug until 93 |
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143 | 143 | | the end of the policy year, based solely on the treating 94 |
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144 | 144 | | physician's certification that the drug is medically necessary; 95 |
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145 | 145 | | and 96 |
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146 | 146 | | (b) May not modify the coverage related to the covered 97 |
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147 | 147 | | drug during the policy year by: 98 |
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148 | 148 | | 1. Increasing the out -of-pocket costs for the covered 99 |
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149 | 149 | | drug; 100 |
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157 | 157 | | Page 5 of 13 |
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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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161 | 161 | | |
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162 | 162 | | 2. Moving the covered drug to a more restrictive tier; 101 |
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163 | 163 | | 3. Denying an insured coverage of the drug for w hich the 102 |
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164 | 164 | | insured has been previously approved for coverage by the 103 |
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165 | 165 | | insurer; or 104 |
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166 | 166 | | 4. Limiting or reducing coverage of the drug in any other 105 |
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167 | 167 | | way, including subjecting it to a new prior authorization or 106 |
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168 | 168 | | step-therapy requirement. 107 |
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169 | 169 | | (4) Subsections (1), (2), and (3) do not: 108 |
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170 | 170 | | (a) Prohibit the addition of prescription drugs to the 109 |
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171 | 171 | | list of drugs covered under the policy during the policy year. 110 |
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172 | 172 | | (b) Apply to a grandfathered health plan as defined in s. 111 |
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173 | 173 | | 627.402 or to benefits specified in s. 627.6513(1) -(14). 112 |
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174 | 174 | | (c) Alter or amend s. 465.025, which provides conditions 113 |
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175 | 175 | | under which a pharmacist may substitute a generically equivalent 114 |
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176 | 176 | | drug product for a brand name drug product. 115 |
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177 | 177 | | (d) Alter or amend s. 465.0252, which provides conditions 116 |
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178 | 178 | | under which a pharmacist may dispe nse a substitute biological 117 |
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179 | 179 | | product for the prescribed biological product. 118 |
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180 | 180 | | (e) Apply to a Medicaid managed care plan under part IV of 119 |
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181 | 181 | | chapter 409. 120 |
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182 | 182 | | (5) A health insurer shall maintain a record of any change 121 |
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183 | 183 | | in its formulary during a calendar year. By Ma rch 1 of each 122 |
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184 | 184 | | year, a health insurer shall submit to the office a report 123 |
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185 | 185 | | delineating such changes made in the previous calendar year. The 124 |
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186 | 186 | | annual report must include, at a minimum: 125 |
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194 | 194 | | Page 6 of 13 |
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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 | | (a) A list of all drugs removed from the formulary and the 126 |
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200 | 200 | | reasons for the removal; 127 |
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201 | 201 | | (b) A list of all drugs moved to a tier resulting in 128 |
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202 | 202 | | additional out-of-pocket costs to insureds; 129 |
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203 | 203 | | (c) The number of insureds notified by the insurer of a 130 |
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204 | 204 | | change in the formulary; and 131 |
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205 | 205 | | (d) The increased cost, by dollar amount, incurred by 132 |
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206 | 206 | | insureds because of such change in the formulary. 133 |
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207 | 207 | | (6) By May 1 of each year, the office shall: 134 |
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208 | 208 | | (a) Compile the data in the annual reports submitted by 135 |
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209 | 209 | | health insurers under subsection (5) and prepare a report 136 |
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210 | 210 | | summarizing the data submitted; 137 |
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211 | 211 | | (b) Make the report publicly accessible on its website; 138 |
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212 | 212 | | and 139 |
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213 | 213 | | (c) Submit the report to the Governor, the President of 140 |
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214 | 214 | | the Senate, and the Speaker of the House of Representatives. 141 |
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215 | 215 | | Section 2. Paragraph (e) of subsection (5) of section 142 |
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216 | 216 | | 627.6699, Florida Statutes, is a mended to read: 143 |
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217 | 217 | | 627.6699 Employee Health Care Access Act. — 144 |
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218 | 218 | | (5) AVAILABILITY OF COVERAGE. — 145 |
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219 | 219 | | (e) All health benefit plans issued under this section 146 |
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220 | 220 | | must comply with the following conditions: 147 |
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221 | 221 | | 1. For employers who have fewer than two employees, a late 148 |
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222 | 222 | | enrollee may be excluded from coverage for no longer than 24 149 |
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223 | 223 | | months if he or she was not covered by creditable coverage 150 |
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231 | 231 | | Page 7 of 13 |
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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 | | continually to a date not more than 63 days before the effective 151 |
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237 | 237 | | date of his or her new coverage. 152 |
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238 | 238 | | 2. Any requirement used by a small em ployer carrier in 153 |
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239 | 239 | | determining whether to provide coverage to a small employer 154 |
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240 | 240 | | group, including requirements for minimum participation of 155 |
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241 | 241 | | eligible employees and minimum employer contributions, must be 156 |
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242 | 242 | | applied uniformly among all small employer groups having the 157 |
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243 | 243 | | same number of eligible employees applying for coverage or 158 |
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244 | 244 | | receiving coverage from the small employer carrier, except that 159 |
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245 | 245 | | a small employer carrier that participates in, administers, or 160 |
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246 | 246 | | issues health benefits pursuant to s. 381.0406 which do not 161 |
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247 | 247 | | include a preexisting condition exclusion may require as a 162 |
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248 | 248 | | condition of offering such benefits that the employer has had no 163 |
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249 | 249 | | health insurance coverage for its employees for a period of at 164 |
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250 | 250 | | least 6 months. A small employer carrier may vary application of 165 |
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251 | 251 | | minimum participation requirements and minimum employer 166 |
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252 | 252 | | contribution requirements only by the size of the small employer 167 |
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253 | 253 | | group. 168 |
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254 | 254 | | 3. In applying minimum participation requirements with 169 |
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255 | 255 | | respect to a small employer, a small employer carrier shall not 170 |
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256 | 256 | | consider as an eligible employee employees or dependents who 171 |
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257 | 257 | | have qualifying existing coverage in an employer -based group 172 |
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258 | 258 | | insurance plan or an ERISA qualified self -insurance plan in 173 |
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259 | 259 | | determining whether the applicable percentage of participation 174 |
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260 | 260 | | is met. However, a small em ployer carrier may count eligible 175 |
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268 | 268 | | Page 8 of 13 |
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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 | | employees and dependents who have coverage under another health 176 |
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274 | 274 | | plan that is sponsored by that employer. 177 |
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275 | 275 | | 4. A small employer carrier shall not increase any 178 |
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276 | 276 | | requirement for minimum employee participation or any 179 |
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277 | 277 | | requirement for minimum employer contribution applicable to a 180 |
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278 | 278 | | small employer at any time after the small employer has been 181 |
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279 | 279 | | accepted for coverage, unless the employer size has changed, in 182 |
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280 | 280 | | which case the small employer carrier may apply the requirements 183 |
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281 | 281 | | that are applicable to the new group size. 184 |
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282 | 282 | | 5. If a small employer carrier offers coverage to a small 185 |
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283 | 283 | | employer, it must offer coverage to all the small employer's 186 |
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284 | 284 | | eligible employees and their dependents. A small employer 187 |
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285 | 285 | | carrier may not offer coverage limited to certai n persons in a 188 |
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286 | 286 | | group or to part of a group, except with respect to late 189 |
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287 | 287 | | enrollees. 190 |
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288 | 288 | | 6. A small employer carrier may not modify any health 191 |
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289 | 289 | | benefit plan issued to a small employer with respect to a small 192 |
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290 | 290 | | employer or any eligible employee or dependent throug h riders, 193 |
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291 | 291 | | endorsements, or otherwise to restrict or exclude coverage for 194 |
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292 | 292 | | certain diseases or medical conditions otherwise covered by the 195 |
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293 | 293 | | health benefit plan. 196 |
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294 | 294 | | 7. An initial enrollment period of at least 30 days must 197 |
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295 | 295 | | be provided. An annual 30 -day open enrollment period must be 198 |
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296 | 296 | | offered to each small employer's eligible employees and their 199 |
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297 | 297 | | dependents. A small employer carrier must provide special 200 |
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305 | 305 | | Page 9 of 13 |
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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 | | enrollment periods as required by s. 627.65615. 201 |
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311 | 311 | | 8. A small employer carrier shall comply with s. 627.42394 202 |
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312 | 312 | | for any change to a prescription drug formulary. 203 |
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313 | 313 | | Section 3. Subsection (36) of section 641.31, Florida 204 |
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314 | 314 | | Statutes, is amended to read: 205 |
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315 | 315 | | 641.31 Health maintenance contracts. — 206 |
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316 | 316 | | (36) Except as provided in paragraphs (a), (b), and (c), a 207 |
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317 | 317 | | health maintenance organization may increase the copayment for 208 |
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318 | 318 | | any benefit, or delete, amend, or limit any of the benefits to 209 |
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319 | 319 | | which a subscriber is entitled under the group contract only, 210 |
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320 | 320 | | upon written notice to the contract holder at least 45 days in 211 |
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321 | 321 | | advance of the time of coverage renewal. The health maintenance 212 |
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322 | 322 | | organization may amend the contract with the contract holder, 213 |
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323 | 323 | | with such amendment to be effective immediately at the time of 214 |
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324 | 324 | | coverage renewal. The written notice to the contract holder must 215 |
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325 | 325 | | shall specifically identify any deletions, amendments, or 216 |
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326 | 326 | | limitations to any of the benefits provided in the group 217 |
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327 | 327 | | contract during the current contract period which will be 218 |
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328 | 328 | | included in the group contract upon renewal. This subsection 219 |
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329 | 329 | | does not apply to any incr eases in benefits. The 45 -day notice 220 |
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330 | 330 | | requirement does shall not apply if benefits are amended, 221 |
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331 | 331 | | deleted, or limited at the request of the contract holder. 222 |
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332 | 332 | | (a) At least 60 days before the effective date of any 223 |
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333 | 333 | | change to a prescription drug formulary during a contract year, 224 |
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334 | 334 | | a health maintenance organization shall notify: 225 |
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342 | 342 | | Page 10 of 13 |
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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 | | 1. Current and prospective subscribers of the change in 226 |
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348 | 348 | | the formulary in a readily accessible format on the health 227 |
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349 | 349 | | maintenance organization's website; and 228 |
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350 | 350 | | 2. Any subscriber currently rec eiving coverage for a 229 |
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351 | 351 | | prescription drug for which the formulary change modifies 230 |
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352 | 352 | | coverage and the subscriber's treating physician. Such 231 |
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353 | 353 | | notification must be sent electronically and by first -class mail 232 |
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354 | 354 | | and must include information on the specific drugs invol ved and 233 |
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355 | 355 | | a statement that the submission of a notice of medical necessity 234 |
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356 | 356 | | by the subscriber's treating physician to the health maintenance 235 |
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357 | 357 | | organization at least 30 days before the effective date of the 236 |
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358 | 358 | | formulary change will result in continuation of coverag e at the 237 |
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359 | 359 | | existing level. 238 |
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360 | 360 | | (b) The notice provided by the treating physician to the 239 |
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361 | 361 | | health maintenance organization must include a completed one -240 |
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362 | 362 | | page form in which the treating physician certifies to the 241 |
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363 | 363 | | health maintenance organization that the prescriptio n drug for 242 |
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364 | 364 | | the subscriber is medically necessary as defined in s. 243 |
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365 | 365 | | 627.732(2). The treating physician shall submit the notice 244 |
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366 | 366 | | electronically or by first -class mail. The health maintenance 245 |
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367 | 367 | | organization may provide the treating physician with access to 246 |
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368 | 368 | | an electronic portal through which the treating physician may 247 |
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369 | 369 | | electronically submit the notice. By January 1, 2025, the 248 |
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370 | 370 | | commission shall adopt by rule a form for the notice. 249 |
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371 | 371 | | (c) If the treating physician certifies to the health 250 |
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379 | 379 | | Page 11 of 13 |
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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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382 | 382 | | |
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383 | 383 | | |
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384 | 384 | | maintenance organization in acco rdance with paragraph (b) that 251 |
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385 | 385 | | the prescription drug is medically necessary for the subscriber, 252 |
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386 | 386 | | the health maintenance organization: 253 |
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387 | 387 | | 1. Must authorize coverage for the prescribed drug until 254 |
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388 | 388 | | the end of the contract year, based solely on the treating 255 |
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389 | 389 | | physician's certification that the drug is medically necessary; 256 |
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390 | 390 | | and 257 |
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391 | 391 | | 2. May not modify the coverage related to the covered drug 258 |
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392 | 392 | | during the contract year by: 259 |
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393 | 393 | | a. Increasing the out -of-pocket costs for the covered 260 |
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394 | 394 | | drug; 261 |
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395 | 395 | | b. Moving the covered drug to a more re strictive tier; 262 |
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396 | 396 | | c. Denying a subscriber coverage of the drug for which the 263 |
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397 | 397 | | subscriber has been previously approved for coverage by the 264 |
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398 | 398 | | health maintenance organization; or 265 |
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399 | 399 | | d. Limiting or reducing coverage of the drug in any other 266 |
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400 | 400 | | way, including subjecti ng it to a new prior authorization or 267 |
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401 | 401 | | step-therapy requirement. 268 |
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402 | 402 | | (d) Paragraphs (a), (b), and (c) do not: 269 |
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403 | 403 | | 1. Prohibit the addition of prescription drugs to the list 270 |
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404 | 404 | | of drugs covered under the contract during the contract year. 271 |
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405 | 405 | | 2. Apply to a grandfathe red health plan as defined in s. 272 |
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406 | 406 | | 627.402 or to benefits specified in s. 627.6513(1) -(14). 273 |
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407 | 407 | | 3. Alter or amend s. 465.025, which provides conditions 274 |
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408 | 408 | | under which a pharmacist may substitute a generically equivalent 275 |
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414 | 414 | | CODING: Words stricken are deletions; words underlined are additions. |
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416 | 416 | | Page 12 of 13 |
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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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421 | 421 | | drug product for a brand name drug product. 276 |
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422 | 422 | | 4. Alter or amend s. 465.0252, which provides conditions 277 |
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423 | 423 | | under which a pharmacist may dispense a substitute biological 278 |
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424 | 424 | | product for the prescribed biological product. 279 |
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425 | 425 | | 5. Apply to a Medicaid managed care plan under part IV of 280 |
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426 | 426 | | chapter 409. 281 |
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427 | 427 | | (e) A health maintenance organization shall maintain a 282 |
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428 | 428 | | record of any change in its formulary during a calendar year. By 283 |
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429 | 429 | | March 1 of each year, a health maintenance organization shall 284 |
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430 | 430 | | submit to the office a report delineating such changes made in 285 |
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431 | 431 | | the previous calendar y ear. The annual report must include, at a 286 |
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432 | 432 | | minimum: 287 |
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433 | 433 | | 1. A list of all drugs removed from the formulary and the 288 |
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434 | 434 | | reasons for the removal; 289 |
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435 | 435 | | 2. A list of all drugs moved to a tier resulting in 290 |
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436 | 436 | | additional out-of-pocket costs to subscribers; 291 |
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437 | 437 | | 3. The number of subscribers notified by the health 292 |
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438 | 438 | | maintenance organization of a change in the formulary; and 293 |
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439 | 439 | | 4. The increased cost, by dollar amount, incurred by 294 |
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440 | 440 | | subscribers because of such change in the formulary. 295 |
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441 | 441 | | (f) By May 1 of each year, the office shall: 296 |
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442 | 442 | | 1. Compile the data in such annual reports submitted by 297 |
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443 | 443 | | health maintenance organizations and prepare a report 298 |
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444 | 444 | | summarizing the data submitted; 299 |
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445 | 445 | | 2. Make the report publicly accessible on its website; and 300 |
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454 | 454 | | 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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458 | 458 | | 3. Submit the report to the Governor, the President of t he 301 |
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459 | 459 | | Senate, and the Speaker of the House of Representatives. 302 |
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460 | 460 | | Section 4. This act applies to health insurance policies, 303 |
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461 | 461 | | health benefit plans, and health maintenance contracts entered 304 |
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462 | 462 | | into or renewed on or after January 1, 2025. 305 |
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463 | 463 | | Section 5. The Legislature finds that this act fulfills an 306 |
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464 | 464 | | important state interest. 307 |
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465 | 465 | | Section 6. This act shall take effect January 1, 2025. 308 |
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