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3 | 3 | | HB 633 2022 |
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9 | 9 | | Page 1 of 9 |
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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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14 | 14 | | A bill to be entitled 1 |
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15 | 15 | | An act relating to insurance coverages for drugs and 2 |
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16 | 16 | | medical procedures and treatments; amending s. 3 |
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17 | 17 | | 627.4239, F.S.; defining the terms "associated 4 |
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18 | 18 | | condition" and "health care provider"; prohibiting 5 |
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19 | 19 | | health maintenance organizations from excluding 6 |
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20 | 20 | | coverage for certain cancer treatment drugs; 7 |
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21 | 21 | | prohibiting health insurers and health maintenance 8 |
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22 | 22 | | organizations from requiring, before providing 9 |
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23 | 23 | | prescription drug coverage for the treatment of stage 10 |
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24 | 24 | | 4 metastatic cancer and associated conditions, that 11 |
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25 | 25 | | treatment have failed with a different drug; providing 12 |
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26 | 26 | | applicability; prohibiting insurers and health 13 |
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27 | 27 | | maintenance organizations from excluding coverage for 14 |
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28 | 28 | | certain drugs on certain grounds; prohibiting insurers 15 |
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29 | 29 | | and health maintenance organizations from requiring 16 |
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30 | 30 | | home infusion for certain cancer treatment drugs or 17 |
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31 | 31 | | that certain cancer treatment drugs be sent to certain 18 |
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32 | 32 | | entities for home infusion unless a certain condition 19 |
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33 | 33 | | is met; revising construction; amending s. 627.42392, 20 |
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34 | 34 | | F.S.; revising the definition of the term "health 21 |
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35 | 35 | | insurer"; defining the term "urgent care situation"; 22 |
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36 | 36 | | specifying a requirement for the prior authorization 23 |
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37 | 37 | | form approved by the Financial Services Commission; 24 |
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38 | 38 | | authorizing the commission to adopt certain rules; 25 |
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39 | 39 | | |
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40 | 40 | | HB 633 2022 |
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46 | 46 | | Page 2 of 9 |
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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 | | specifying requirements for, and restrictions on , 26 |
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52 | 52 | | health insurers and pharmacy benefits managers 27 |
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53 | 53 | | relating to prior authorization information, 28 |
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54 | 54 | | requirements, restrictions, and changes; providing 29 |
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55 | 55 | | applicability; specifying timeframes in which prior 30 |
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56 | 56 | | authorization requests must be authorized or denied 31 |
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57 | 57 | | and the patient and the patient's provider must be 32 |
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58 | 58 | | notified; providing an effective date. 33 |
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59 | 59 | | 34 |
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60 | 60 | | Be It Enacted by the Legislature of the State of Florida: 35 |
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61 | 61 | | 36 |
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62 | 62 | | Section 1. Section 627.4239, Florida Statutes, is amended 37 |
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63 | 63 | | to read: 38 |
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64 | 64 | | 627.4239 Coverage for use of drugs in treatment of 39 |
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65 | 65 | | cancer.— 40 |
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66 | 66 | | (1) DEFINITIONS.—As used in this section, the term: 41 |
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67 | 67 | | (a) "Associated condition" means a symptom or side effect 42 |
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68 | 68 | | that: 43 |
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69 | 69 | | 1. Is associated with a particular cancer at a particular 44 |
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70 | 70 | | stage or with the treatment of that cancer; and 45 |
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71 | 71 | | 2. In the judgment of a health care provider, will further 46 |
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72 | 72 | | jeopardize the health of a patient if left untreated. As used in 47 |
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73 | 73 | | this subparagraph, the term "health care provider" means a 48 |
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74 | 74 | | physician licensed under chapter 458, chapter 459, or chapter 49 |
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75 | 75 | | 461; a physician assistant licensed under chapter 458 or chapter 50 |
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77 | 77 | | HB 633 2022 |
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83 | 83 | | Page 3 of 9 |
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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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87 | 87 | | |
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88 | 88 | | 459; an advanced practice registered nurse licensed under 51 |
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89 | 89 | | chapter 464; or a dentist licensed under chapter 466. 52 |
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90 | 90 | | (b) "Medical literature" means scientific studies 53 |
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91 | 91 | | published in a United States peer -reviewed national professional 54 |
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92 | 92 | | journal. 55 |
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93 | 93 | | (c)(b) "Standard reference compendium" means authoritative 56 |
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94 | 94 | | compendia identified by the Secretary of the United States 57 |
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95 | 95 | | Department of Health and Human Services and recognized by the 58 |
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96 | 96 | | federal Centers for Medicare and Medic aid Services. 59 |
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97 | 97 | | (2) COVERAGE FOR TREATMENT OF CANCER. — 60 |
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98 | 98 | | (a) An insurer or a health maintenance organization may 61 |
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99 | 99 | | not exclude coverage in any individual or group health insurance 62 |
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100 | 100 | | policy or health maintenance contract issued, amended, 63 |
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101 | 101 | | delivered, or renewed i n this state which covers the treatment 64 |
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102 | 102 | | of cancer for any drug prescribed for the treatment of cancer on 65 |
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103 | 103 | | the ground that the drug is not approved by the United States 66 |
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104 | 104 | | Food and Drug Administration for a particular indication, if 67 |
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105 | 105 | | that drug is recognized for treatment of that indication in a 68 |
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106 | 106 | | standard reference compendium or recommended in the medical 69 |
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107 | 107 | | literature. 70 |
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108 | 108 | | (b) Coverage for a drug required by this section also 71 |
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109 | 109 | | includes the medically necessary services associated with the 72 |
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110 | 110 | | administration of the drug. 73 |
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111 | 111 | | (3) COVERAGE FOR TREATMENT OF STAGE 4 METASTATIC CANCER 74 |
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112 | 112 | | AND ASSOCIATED CONDITIONS. — 75 |
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120 | 120 | | Page 4 of 9 |
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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 | | (a) An insurer or a health maintenance organization may 76 |
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126 | 126 | | not require in any individual or group health insurance policy 77 |
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127 | 127 | | or health maintenance contract issued, amended, deliv ered, or 78 |
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128 | 128 | | renewed in this state which covers the treatment of stage 4 79 |
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129 | 129 | | metastatic cancer and its associated conditions that, before a 80 |
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130 | 130 | | drug prescribed for the treatment is covered, the insured or 81 |
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131 | 131 | | subscriber fail or have previously failed to respond 82 |
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132 | 132 | | successfully to a different drug. 83 |
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133 | 133 | | (b) Paragraph (a) applies to a drug that is recognized for 84 |
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134 | 134 | | the treatment of stage 4 metastatic cancer or its associated 85 |
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135 | 135 | | conditions, as applicable, in a standard reference compendium or 86 |
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136 | 136 | | that is recommended in the medical literature. The insurer or 87 |
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137 | 137 | | health maintenance organization may not exclude coverage for 88 |
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138 | 138 | | such drug on the ground that the drug is not approved by the 89 |
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139 | 139 | | United States Food and Drug Administration for stage 4 90 |
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140 | 140 | | metastatic cancer or its associated conditions, as a pplicable. 91 |
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141 | 141 | | (4) COVERAGE FOR SERVICES ASSOCIATED WITH DRUG 92 |
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142 | 142 | | ADMINISTRATION.—Coverage for a drug required by this section 93 |
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143 | 143 | | also includes the medically necessary services associated with 94 |
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144 | 144 | | the administration of the drug. 95 |
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145 | 145 | | (5) PROHIBITION ON MANDATORY HOME INFU SION.—An insurer or 96 |
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146 | 146 | | a health maintenance organization may not require that a cancer 97 |
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147 | 147 | | medication be administered using home infusion, and may not 98 |
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148 | 148 | | require that such medication be sent directly to a third party 99 |
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149 | 149 | | or to the patient for home infusion, unless the p atient's 100 |
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157 | 157 | | Page 5 of 9 |
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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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162 | 162 | | treating oncologist determines that home infusion of the cancer 101 |
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163 | 163 | | medication will not jeopardize the health of the patient. 102 |
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164 | 164 | | (6) APPLICABILITY AND SCOPE. —This section may not be 103 |
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165 | 165 | | construed to: 104 |
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166 | 166 | | (a) Alter any other law with regard to provisions limi ting 105 |
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167 | 167 | | coverage for drugs that are not approved by the United States 106 |
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168 | 168 | | Food and Drug Administration , except for drugs for the treatment 107 |
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169 | 169 | | of stage 4 metastatic cancer or its associated conditions . 108 |
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170 | 170 | | (b) Require coverage for any drug , except for a drug for 109 |
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171 | 171 | | the treatment of stage 4 metastatic cancer or its associated 110 |
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172 | 172 | | conditions, if the United States Food and Drug Administration 111 |
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173 | 173 | | has determined that the use of the drug is contraindicated. 112 |
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174 | 174 | | (c) Require coverage for a drug that is not otherwise 113 |
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175 | 175 | | approved for any indica tion by the United States Food and Drug 114 |
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176 | 176 | | Administration, except for a drug for the treatment of stage 4 115 |
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177 | 177 | | metastatic cancer or its associated conditions . 116 |
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178 | 178 | | (d) Affect the determination as to whether particular 117 |
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179 | 179 | | levels, dosages, or usage of a medication associa ted with bone 118 |
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180 | 180 | | marrow transplant procedures are covered under an individual or 119 |
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181 | 181 | | group health insurance policy or health maintenance organization 120 |
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182 | 182 | | contract. 121 |
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183 | 183 | | (e) Apply to specified disease or supplemental policies. 122 |
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184 | 184 | | (f)(4) Nothing in this section is intended , Expressly or 123 |
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185 | 185 | | by implication, to create, impair, alter, limit, modify, 124 |
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186 | 186 | | enlarge, abrogate, prohibit, or withdraw any authority to 125 |
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188 | 188 | | HB 633 2022 |
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194 | 194 | | Page 6 of 9 |
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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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198 | 198 | | |
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199 | 199 | | provide reimbursement for drugs used in the treatment of any 126 |
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200 | 200 | | other disease or condition. 127 |
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201 | 201 | | Section 2. Section 627.42392, Flo rida Statutes, is amended 128 |
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202 | 202 | | to read: 129 |
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203 | 203 | | (1) As used in this section, the term : 130 |
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204 | 204 | | (a) "Health insurer" means an authorized insurer offering 131 |
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205 | 205 | | an individual or group health insurance policy that provides 132 |
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206 | 206 | | major medical or similar comprehensive coverage health insurance 133 |
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207 | 207 | | as defined in s. 624.603 , a managed care plan as defined in s. 134 |
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208 | 208 | | 409.962(10), or a health maintenance organization as defined in 135 |
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209 | 209 | | s. 641.19(12). 136 |
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210 | 210 | | (b) "Urgent care situation" means an injury or a condition 137 |
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211 | 211 | | of an insured which, if medical care and treatm ent are not 138 |
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212 | 212 | | provided earlier than the time the medical profession generally 139 |
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213 | 213 | | considers reasonable for a nonurgent situation, in the opinion 140 |
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214 | 214 | | of the insured's treating physician, physician assistant, or 141 |
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215 | 215 | | advanced practice registered nurse, would: 142 |
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216 | 216 | | 1. Seriously jeopardize the insured's life, health, or 143 |
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217 | 217 | | ability to regain maximum function; or 144 |
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218 | 218 | | 2. Subject the insured to severe pain that cannot be 145 |
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219 | 219 | | adequately managed. 146 |
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220 | 220 | | (2) Notwithstanding any other provision of law, effective 147 |
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221 | 221 | | January 1, 2023 January 1, 2017, or 6 six (6) months after the 148 |
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222 | 222 | | effective date of the rule adopting the prior authorization 149 |
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223 | 223 | | form, whichever is later, a health insurer, or a pharmacy 150 |
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231 | 231 | | Page 7 of 9 |
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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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236 | 236 | | benefits manager on behalf of the health insurer, which does not 151 |
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237 | 237 | | provide an electronic prior authorization proces s for use by its 152 |
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238 | 238 | | contracted providers, shall only use only the prior 153 |
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239 | 239 | | authorization form that has been approved by the Financial 154 |
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240 | 240 | | Services Commission for granting a prior authorization for a 155 |
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241 | 241 | | medical procedure, course of treatment, or prescription drug 156 |
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242 | 242 | | benefit. Such form may not exceed two pages in length, excluding 157 |
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243 | 243 | | any instructions or guiding documentation, and must include all 158 |
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244 | 244 | | clinical documentation necessary for the health insurer to make 159 |
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245 | 245 | | a decision. At a minimum, the form must include all of the 160 |
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246 | 246 | | following: 161 |
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247 | 247 | | (a)(1) Sufficient patient information to identify the 162 |
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248 | 248 | | member, including his or her date of birth, full name, and 163 |
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249 | 249 | | Health Plan ID number .; 164 |
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250 | 250 | | (b)(2) The provider's provider name, address, and phone 165 |
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251 | 251 | | number.; 166 |
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252 | 252 | | (c)(3) The medical procedure, course of treatment, or 167 |
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253 | 253 | | prescription drug benefit being requested, including the medical 168 |
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254 | 254 | | reason therefor, and all services tried and failed .; 169 |
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255 | 255 | | (d)(4) Any required laboratory documentation . required; 170 |
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256 | 256 | | and 171 |
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257 | 257 | | (e)(5) An attestation that all information provided is 172 |
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258 | 258 | | true and accurate. 173 |
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259 | 259 | | 174 |
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260 | 260 | | The form, whether in electronic or paper format, must require 175 |
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268 | 268 | | Page 8 of 9 |
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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 | | only that information necessary for the determination of the 176 |
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274 | 274 | | medical necessity of, or coverage for, the requested medical 177 |
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275 | 275 | | procedure, course of t reatment, or prescription drug benefit. 178 |
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276 | 276 | | The commission may adopt rules prescribing such necessary 179 |
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277 | 277 | | information. 180 |
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278 | 278 | | (3) The Financial Services Commission in consultation with 181 |
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279 | 279 | | the Agency for Health Care Administration shall adopt by rule 182 |
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280 | 280 | | guidelines for all pri or authorization forms which ensure the 183 |
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281 | 281 | | general uniformity of such forms. 184 |
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282 | 282 | | (4) Electronic prior authorization approvals do not 185 |
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283 | 283 | | preclude benefit verification or medical review by the insurer 186 |
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284 | 284 | | under either the medical or pharmacy benefits. 187 |
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285 | 285 | | Prior authorization.— 188 |
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286 | 286 | | (5) A health insurer, or a pharmacy benefits manager on 189 |
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287 | 287 | | behalf of the health insurer, shall, upon request, provide the 190 |
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288 | 288 | | following information in electronic or paper format and publish 191 |
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289 | 289 | | it on a publicly accessible website: 192 |
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290 | 290 | | (a) Detailed descriptions, i n clear, easily understandable 193 |
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291 | 291 | | language, of the requirements for, and restrictions on, 194 |
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292 | 292 | | obtaining prior authorization for coverage of a medical 195 |
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293 | 293 | | procedure, course of treatment, or prescription drug. Clinical 196 |
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294 | 294 | | criteria must be described in language that a heal th care 197 |
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295 | 295 | | provider can easily understand. 198 |
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296 | 296 | | (b) Prior authorization forms. 199 |
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297 | 297 | | (6) A health insurer, or a pharmacy benefits manager on 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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310 | 310 | | behalf of the health insurer, may not implement any new 201 |
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311 | 311 | | requirements or restrictions or make changes to existing 202 |
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312 | 312 | | requirements or restrictions on obtaining prior authorization 203 |
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313 | 313 | | unless: 204 |
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314 | 314 | | (a) The changes have been available on a publicly 205 |
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315 | 315 | | accessible website for at least 60 days before they are 206 |
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316 | 316 | | implemented; and 207 |
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317 | 317 | | (b) Insureds and health care providers affected by the new 208 |
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318 | 318 | | requirements and restrictions or changes to the requirements and 209 |
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319 | 319 | | restrictions are provided with a written notice of the changes 210 |
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320 | 320 | | at least 60 days before they are implemented. Such notice may be 211 |
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321 | 321 | | delivered electronically or by other means as agreed to by the 212 |
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322 | 322 | | insured or the health care provider. 213 |
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323 | 323 | | 214 |
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324 | 324 | | This subsection does not apply to the expansion of health care 215 |
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325 | 325 | | services coverage. 216 |
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326 | 326 | | (7) A health insurer, or a pharmacy benefits manager on 217 |
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327 | 327 | | behalf of the health insurer, shall authorize or deny a prior 218 |
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328 | 328 | | authorization request and no tify the patient and the patient's 219 |
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329 | 329 | | treating health care provider of the decision within: 220 |
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330 | 330 | | (a) Seventy-two hours after receiving a completed prior 221 |
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331 | 331 | | authorization form for nonurgent care situations. 222 |
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332 | 332 | | (b) Twenty-four hours after receiving a completed prior 223 |
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333 | 333 | | authorization form for urgent care situations. 224 |
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334 | 334 | | Section 3. This act shall take effect January 1, 2023. 225 |
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