15 | 15 | | An act relating to step -therapy protocols; amending s. 2 |
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16 | 16 | | 627.42393, F.S.; revising the circumstances under 3 |
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17 | 17 | | which step-therapy protocols may not be required; 4 |
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18 | 18 | | defining terms; requiring health insurers to publish 5 |
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19 | 19 | | on their websites and provide to their insureds 6 |
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20 | 20 | | specified information; providing requirements for 7 |
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21 | 21 | | procedures for requests and appeals of denials of 8 |
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22 | 22 | | protocol exemptions; providing requirements for 9 |
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23 | 23 | | authorizations and denials of protocol exemption 10 |
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24 | 24 | | requests; authorizing health insurers to request 11 |
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25 | 25 | | specified documentation under certain circumstances; 12 |
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26 | 26 | | amending s. 641.31, F.S.; revising the circumstances 13 |
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27 | 27 | | under which step-therapy protocols may not be 14 |
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28 | 28 | | required; defining terms; requiring health maintenance 15 |
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29 | 29 | | organizations to publish on their websites and provide 16 |
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30 | 30 | | to their subscribers specified information; providing 17 |
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31 | 31 | | requirements for procedures for requests and appeals 18 |
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32 | 32 | | of denials of protocol exemptions; providing 19 |
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33 | 33 | | requirements for authorizations and denials of 20 |
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34 | 34 | | protocol exemption requests; authorizing health 21 |
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35 | 35 | | maintenance organizations to request specified 22 |
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36 | 36 | | documentation under certain circumstances; providing 23 |
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37 | 37 | | an effective date. 24 |
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38 | 38 | | 25 |
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50 | 50 | | |
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51 | 51 | | Be It Enacted by the Legislature of the Stat e of Florida: 26 |
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52 | 52 | | 27 |
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53 | 53 | | Section 1. Section 627.42393, Florida Statutes, is amended 28 |
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54 | 54 | | to read: 29 |
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55 | 55 | | 627.42393 Step-therapy protocol.— 30 |
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56 | 56 | | (1)(2) As used in this section, the term : 31 |
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57 | 57 | | (a) "Health coverage plan" means any of the following 32 |
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58 | 58 | | which is currently or was previou sly providing major medical or 33 |
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59 | 59 | | similar comprehensive coverage or benefits to the insured: 34 |
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60 | 60 | | 1.(a) A health insurer or health maintenance organization. 35 |
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61 | 61 | | 2.(b) A plan established or maintained by an individual 36 |
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62 | 62 | | employer as provided by the Employee Retirement Income Security 37 |
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63 | 63 | | Act of 1974, Pub. L. No. 93 -406. 38 |
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64 | 64 | | 3.(c) A multiple-employer welfare arrangement as defined 39 |
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65 | 65 | | in s. 624.437. 40 |
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66 | 66 | | 4.(d) A governmental entity providing a plan of self -41 |
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67 | 67 | | insurance. 42 |
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68 | 68 | | (b) "Protocol exemption" means a determination by a health 43 |
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69 | 69 | | insurer to authorize the use of another prescription drug, 44 |
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70 | 70 | | medical procedure, or course of treatment prescribed or 45 |
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71 | 71 | | recommended by the treating health care provider for the 46 |
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72 | 72 | | insured's condition rather than the one specified by the health 47 |
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73 | 73 | | insurer's step-therapy protocol. 48 |
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74 | 74 | | (c) "Step-therapy protocol" means a written protocol that 49 |
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75 | 75 | | specifies the order in which certain prescription drugs, medical 50 |
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83 | 83 | | Page 3 of 7 |
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85 | 85 | | |
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86 | 86 | | |
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87 | 87 | | |
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88 | 88 | | procedures, or courses of treatment must be used to treat an 51 |
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89 | 89 | | insured's condition. 52 |
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90 | 90 | | (2)(1) In addition to the protocol exem ptions granted 53 |
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91 | 91 | | under subsection (3), a health insurer issuing a major medical 54 |
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92 | 92 | | individual or group policy may not require a step -therapy 55 |
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93 | 93 | | protocol under the policy for a covered prescription drug 56 |
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94 | 94 | | requested by an insured if: 57 |
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95 | 95 | | (a) The insured has previously b een approved to receive 58 |
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96 | 96 | | the prescription drug through the completion of a step -therapy 59 |
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97 | 97 | | protocol required by a separate health coverage plan; and 60 |
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98 | 98 | | (b) The insured provides documentation originating from 61 |
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99 | 99 | | the health coverage plan that approved the prescription drug as 62 |
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100 | 100 | | described in paragraph (a) indicating that the health coverage 63 |
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101 | 101 | | plan paid for the drug on the insured's behalf during the 90 64 |
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102 | 102 | | days immediately before the request. 65 |
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103 | 103 | | (3)(a) A health insurer shall publish on its website and 66 |
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104 | 104 | | provide to an insured in writing a procedure for the insured and 67 |
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105 | 105 | | his or her health care provider to request a protocol exemption 68 |
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106 | 106 | | or an appeal of the health insurer's denial of a protocol 69 |
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107 | 107 | | exemption request. The procedure must include, at a minimum: 70 |
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108 | 108 | | 1. The manner in whic h the insured or health care provider 71 |
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109 | 109 | | may request a protocol exemption, including a form to request 72 |
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110 | 110 | | the protocol exemption. 73 |
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111 | 111 | | 2. The manner and timeframe in which the health insurer 74 |
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112 | 112 | | authorizes or denies a protocol exemption request, which must 75 |
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125 | 125 | | occur within a reasonable time. 76 |
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126 | 126 | | 3. The manner and timeframe in which the insured or health 77 |
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127 | 127 | | care provider may appeal the health insurer's denial of a 78 |
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128 | 128 | | protocol exemption request. 79 |
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129 | 129 | | (b) An authorization of a protocol exemption request must 80 |
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130 | 130 | | specify the approved prescrip tion drug, medical procedure, or 81 |
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131 | 131 | | course of treatment. A denial of a protocol exemption request 82 |
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132 | 132 | | must include a written explanation of the reason for the denial, 83 |
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133 | 133 | | the clinical rationale that supports the denial, and the 84 |
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134 | 134 | | procedure for appealing the health insu rer's denial. 85 |
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135 | 135 | | (c) A health insurer may request relevant medical records 86 |
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136 | 136 | | in support of a protocol exemption request. 87 |
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137 | 137 | | (4)(3) This section does not require a health insurer to 88 |
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138 | 138 | | add a drug to its prescription drug formulary or to cover a 89 |
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139 | 139 | | prescription drug that the insurer does not otherwise cover. 90 |
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140 | 140 | | Section 2. Subsection (46) of section 641.31, Florida 91 |
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141 | 141 | | Statutes, is amended to read: 92 |
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142 | 142 | | 641.31 Health maintenance contracts. — 93 |
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143 | 143 | | (46)(a)(b) As used in this subsection, the term : 94 |
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144 | 144 | | 1. "Health coverage plan" means a ny of the following which 95 |
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145 | 145 | | previously provided or is currently providing major medical or 96 |
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146 | 146 | | similar comprehensive coverage or benefits to the subscriber: 97 |
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147 | 147 | | a.1. A health insurer or health maintenance organization .; 98 |
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148 | 148 | | b.2. A plan established or maintained by a n individual 99 |
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149 | 149 | | employer as provided by the Employee Retirement Income Security 100 |
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157 | 157 | | Page 5 of 7 |
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161 | 161 | | |
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162 | 162 | | Act of 1974, Pub. L. No. 93 -406.; 101 |
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163 | 163 | | c.3. A multiple-employer welfare arrangement as defined in 102 |
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164 | 164 | | s. 624.437.; or 103 |
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165 | 165 | | d.4. A governmental entity providing a plan of self -104 |
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166 | 166 | | insurance. 105 |
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167 | 167 | | 2. "Protocol exemption" means a determination by a health 106 |
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168 | 168 | | maintenance organization to authorize the use of another 107 |
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169 | 169 | | prescription drug, medical procedure, or course of treatment 108 |
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170 | 170 | | prescribed or recommended by the treating health care provider 109 |
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171 | 171 | | for the subscriber's condition rather than the one specified by 110 |
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172 | 172 | | the health maintenance organization's step -therapy protocol. 111 |
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173 | 173 | | 3. "Step-therapy protocol" means a written protocol that 112 |
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174 | 174 | | specifies the order in which certain prescription drugs, medical 113 |
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175 | 175 | | procedures, or courses of treatment must be used to treat a 114 |
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176 | 176 | | subscriber's condition. 115 |
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177 | 177 | | (b)(a) In addition to the protocol exemptions granted 116 |
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178 | 178 | | under paragraph (c), a health maintenance organization issuing 117 |
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179 | 179 | | major medical coverage through an individual or group contract 118 |
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180 | 180 | | may not require a step-therapy protocol under the contract for a 119 |
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181 | 181 | | covered prescription drug requested by a subscriber if: 120 |
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182 | 182 | | 1. The subscriber has previously been approved to receive 121 |
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183 | 183 | | the prescription drug through the completion of a step -therapy 122 |
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184 | 184 | | protocol required by a sepa rate health coverage plan; and 123 |
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185 | 185 | | 2. The subscriber provides documentation originating from 124 |
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186 | 186 | | the health coverage plan that approved the prescription drug as 125 |
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194 | 194 | | Page 6 of 7 |
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199 | 199 | | described in subparagraph 1. indicating that the health coverage 126 |
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200 | 200 | | plan paid for the drug on the subscr iber's behalf during the 90 127 |
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201 | 201 | | days immediately before the request. 128 |
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202 | 202 | | (c)1. A health maintenance organization shall publish on 129 |
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203 | 203 | | its website and provide to a subscriber in writing a procedure 130 |
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204 | 204 | | for the subscriber and his or her health care provider to 131 |
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205 | 205 | | request a protocol exemption or an appeal of the health 132 |
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206 | 206 | | maintenance organization's denial of a protocol exemption 133 |
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207 | 207 | | request. The procedure must include, at a minimum: 134 |
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208 | 208 | | a. The manner in which the subscriber or health care 135 |
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209 | 209 | | provider may request a protocol exemption, incl uding a form to 136 |
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210 | 210 | | request the protocol exemption. 137 |
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211 | 211 | | b. The manner and timeframe in which the health 138 |
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212 | 212 | | maintenance organization authorizes or denies a protocol 139 |
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213 | 213 | | exemption request, which must occur within a reasonable time. 140 |
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214 | 214 | | c. The manner and timeframe in which the subscriber or 141 |
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215 | 215 | | health care provider may appeal the health maintenance 142 |
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216 | 216 | | organization's denial of a protocol exemption request . 143 |
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217 | 217 | | 2. An authorization of a protocol exemption request must 144 |
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218 | 218 | | specify the approved prescription drug, medical procedure, or 145 |
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219 | 219 | | course of treatment. A denial of a protocol exemption request 146 |
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220 | 220 | | must include a written explanation of the reason for the denial, 147 |
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221 | 221 | | the clinical rationale that supports the denial, and the 148 |
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222 | 222 | | procedure for appealing the health maintenance organization's 149 |
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223 | 223 | | denial. 150 |
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231 | 231 | | Page 7 of 7 |
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235 | 235 | | |
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236 | 236 | | 3. A health maintenance organization may request relevant 151 |
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237 | 237 | | medical records in support of a protocol exemption request. 152 |
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238 | 238 | | (d)(c) This subsection does not require a health 153 |
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239 | 239 | | maintenance organization to add a drug to its prescription drug 154 |
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240 | 240 | | formulary or to cover a prescr iption drug that the health 155 |
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241 | 241 | | maintenance organization does not otherwise cover. 156 |
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242 | 242 | | Section 3. This act shall take effect July 1, 2022. 157 |
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