1 | 1 | | 89R12912 RDS-D |
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2 | 2 | | By: Darby H.B. No. 3265 |
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3 | 3 | | |
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4 | 4 | | |
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5 | 5 | | |
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6 | 6 | | |
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7 | 7 | | A BILL TO BE ENTITLED |
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8 | 8 | | AN ACT |
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9 | 9 | | relating to discriminatory practices by a health benefit plan |
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10 | 10 | | issuer, pharmacy benefit manager, and third-party payor and certain |
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11 | 11 | | prescription drug manufacturers, distributors, and related persons |
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12 | 12 | | with respect to certain entities participating in a federal drug |
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13 | 13 | | discount program; providing a civil penalty. |
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14 | 14 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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15 | 15 | | SECTION 1. Subchapter N, Chapter 431, Health and Safety |
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16 | 16 | | Code, is amended by adding Section 431.416 to read as follows: |
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17 | 17 | | Sec. 431.416. DISCRIMINATION WITH RESPECT TO FEDERAL 340B |
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18 | 18 | | DRUG DISCOUNT PROGRAM PROHIBITED. (a) In this section: |
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19 | 19 | | (1) "340B drug" and "covered entity" have the meanings |
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20 | 20 | | assigned by Section 1369.701, Insurance Code. |
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21 | 21 | | (2) "Package" has the meaning assigned by 21 U.S.C. |
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22 | 22 | | Section 360eee(11)(A). |
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23 | 23 | | (3) "Pharmacist" and "pharmacy" have the meanings |
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24 | 24 | | assigned by Section 551.003, Occupations Code. |
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25 | 25 | | (b) Except as provided by Subsection (c), a manufacturer, |
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26 | 26 | | repackager, logistics provider, third-party logistics provider, |
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27 | 27 | | wholesale distributor, or agent of a prescription drug may not, |
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28 | 28 | | either directly or indirectly: |
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29 | 29 | | (1) discriminate against a covered entity, a |
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30 | 30 | | pharmacist or pharmacy that is under contract with the covered |
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31 | 31 | | entity, or another entity that is authorized under the contract to |
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32 | 32 | | receive the drug on behalf of the covered entity; |
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33 | 33 | | (2) deny, restrict, prohibit, or otherwise limit the |
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34 | 34 | | acquisition of a 340B drug by, or delivery of the drug to, a covered |
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35 | 35 | | entity, a pharmacist or pharmacy that is under contract with the |
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36 | 36 | | covered entity, or another entity that is authorized under the |
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37 | 37 | | contract to receive the drug on behalf of the covered entity; or |
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38 | 38 | | (3) require a covered entity, a pharmacist or pharmacy |
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39 | 39 | | that is under contract with the covered entity, or another entity |
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40 | 40 | | that is authorized under the contract to receive a 340B drug on |
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41 | 41 | | behalf of the covered entity to submit any claim or utilization data |
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42 | 42 | | as a condition for the acquisition of a 340B drug by, or delivery of |
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43 | 43 | | a 340B drug to, the covered entity, pharmacist or pharmacy under |
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44 | 44 | | contract with the covered entity, or other entity authorized to |
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45 | 45 | | receive the drug, as applicable. |
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46 | 46 | | (c) This section does not apply to: |
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47 | 47 | | (1) the receipt of a 340B drug that is prohibited by |
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48 | 48 | | the United States Food and Drug Administration; or |
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49 | 49 | | (2) the submission of a claim or utilization data that |
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50 | 50 | | is required by the United States Department of Health and Human |
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51 | 51 | | Services. |
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52 | 52 | | (d) A person who has reasonable cause to believe another |
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53 | 53 | | person has violated this section may submit a complaint to the |
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54 | 54 | | department. The department may investigate the complaint. If the |
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55 | 55 | | department finds that the person subject to the complaint committed |
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56 | 56 | | a violation of this section, the department: |
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57 | 57 | | (1) shall refer the complaint to the attorney general; |
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58 | 58 | | and |
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59 | 59 | | (2) may, in accordance with Section 431.414, suspend |
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60 | 60 | | or revoke a license issued under this subchapter and held by the |
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61 | 61 | | person subject to the complaint. |
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62 | 62 | | (e) A person who violates this section commits a false, |
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63 | 63 | | misleading, or deceptive act or practice under Section 17.46, |
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64 | 64 | | Business & Commerce Code, except that a civil penalty may be |
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65 | 65 | | assessed in an amount not greater than $50,000 for each violation. A |
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66 | 66 | | person commits a separate violation for each package of 340B drugs |
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67 | 67 | | that is the subject of a violation of this section. |
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68 | 68 | | (f) The executive commissioner shall adopt rules necessary |
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69 | 69 | | to implement this section. |
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70 | 70 | | (g) This section does not create a private cause of action |
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71 | 71 | | against a person who violates this section. |
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72 | 72 | | (h) Nothing in this section may be construed or applied to |
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73 | 73 | | be: |
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74 | 74 | | (1) less restrictive than any federal law as to any |
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75 | 75 | | person regulated by this section; or |
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76 | 76 | | (2) in conflict with: |
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77 | 77 | | (A) federal law or a related regulation; or |
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78 | 78 | | (B) any law of this state that is compatible with |
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79 | 79 | | applicable federal law. |
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80 | 80 | | SECTION 2. Chapter 1369, Insurance Code, is amended by |
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81 | 81 | | adding Subchapter O to read as follows: |
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82 | 82 | | SUBCHAPTER O. PROHIBITION ON DISCRIMINATION WITH RESPECT TO |
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83 | 83 | | FEDERAL 340B DRUG DISCOUNT PROGRAM |
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84 | 84 | | Sec. 1369.701. DEFINITIONS. In this subchapter: |
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85 | 85 | | (1) "340B drug" means a covered outpatient drug within |
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86 | 86 | | the meaning of 42 U.S.C. Section 256b that has been subject to any |
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87 | 87 | | offer for reduced prices by a manufacturer under the 340B program |
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88 | 88 | | and is purchased, or is intended to be purchased, by a covered |
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89 | 89 | | entity. |
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90 | 90 | | (2) "340B program" means the federal drug discount |
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91 | 91 | | program established by Section 340B, Public Health Service Act (42 |
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92 | 92 | | U.S.C. Section 256b). |
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93 | 93 | | (3) "Covered entity" has the meaning assigned by 42 |
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94 | 94 | | U.S.C. Section 256b(a)(4). |
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95 | 95 | | (4) "Manufacturer" has the meaning assigned by Section |
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96 | 96 | | 431.401, Health and Safety Code. |
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97 | 97 | | (5) "Non-covered entity" means an entity that is not a |
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98 | 98 | | covered entity. |
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99 | 99 | | (6) "Pharmacy benefit manager" has the meaning |
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100 | 100 | | assigned by Section 4151.151. |
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101 | 101 | | (7) "Third-party payor" means any person, other than a |
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102 | 102 | | pharmacy benefit manager, health benefit plan issuer, patient, or |
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103 | 103 | | individual paying for a patient's drugs on the patient's behalf, |
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104 | 104 | | that makes payment for drugs dispensed by a pharmacist or pharmacy |
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105 | 105 | | or administered by a health care professional. |
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106 | 106 | | Sec. 1369.702. APPLICABILITY OF SUBCHAPTER. (a) This |
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107 | 107 | | subchapter applies only to a health benefit plan that provides |
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108 | 108 | | benefits for medical or surgical expenses incurred as a result of a |
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109 | 109 | | health condition, accident, or sickness, including an individual, |
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110 | 110 | | group, blanket, or franchise insurance policy or insurance |
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111 | 111 | | agreement, a group hospital service contract, or an individual or |
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112 | 112 | | group evidence of coverage or similar coverage document that is |
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113 | 113 | | issued by: |
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114 | 114 | | (1) an insurance company; |
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115 | 115 | | (2) a group hospital service corporation operating |
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116 | 116 | | under Chapter 842; |
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117 | 117 | | (3) a health maintenance organization operating under |
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118 | 118 | | Chapter 843; |
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119 | 119 | | (4) an approved nonprofit health corporation that |
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120 | 120 | | holds a certificate of authority under Chapter 844; |
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121 | 121 | | (5) a multiple employer welfare arrangement that holds |
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122 | 122 | | a certificate of authority under Chapter 846; |
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123 | 123 | | (6) a stipulated premium company operating under |
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124 | 124 | | Chapter 884; |
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125 | 125 | | (7) a fraternal benefit society operating under |
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126 | 126 | | Chapter 885; |
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127 | 127 | | (8) a Lloyd's plan operating under Chapter 941; or |
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128 | 128 | | (9) an exchange operating under Chapter 942. |
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129 | 129 | | (b) Notwithstanding any other law, this subchapter applies |
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130 | 130 | | to: |
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131 | 131 | | (1) a small employer health benefit plan subject to |
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132 | 132 | | Chapter 1501, including coverage provided through a health group |
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133 | 133 | | cooperative under Subchapter B of that chapter; |
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134 | 134 | | (2) a standard health benefit plan issued under |
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135 | 135 | | Chapter 1507; |
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136 | 136 | | (3) a basic coverage plan under Chapter 1551; |
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137 | 137 | | (4) a basic plan under Chapter 1575; |
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138 | 138 | | (5) a primary care coverage plan under Chapter 1579; |
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139 | 139 | | (6) a plan providing basic coverage under Chapter |
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140 | 140 | | 1601; |
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141 | 141 | | (7) nonprofit agricultural organization health |
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142 | 142 | | benefits offered by a nonprofit agricultural organization under |
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143 | 143 | | Chapter 1682; |
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144 | 144 | | (8) alternative health benefit coverage offered by a |
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145 | 145 | | subsidiary of the Texas Mutual Insurance Company under Subchapter |
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146 | 146 | | M, Chapter 2054; |
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147 | 147 | | (9) health benefits provided by or through a church |
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148 | 148 | | benefits board under Subchapter I, Chapter 22, Business |
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149 | 149 | | Organizations Code; |
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150 | 150 | | (10) group health coverage made available by a school |
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151 | 151 | | district in accordance with Section 22.004, Education Code; |
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152 | 152 | | (11) the state Medicaid program, including the |
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153 | 153 | | Medicaid managed care program operated under Chapter 540, |
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154 | 154 | | Government Code; |
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155 | 155 | | (12) the child health plan program under Chapter 62, |
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156 | 156 | | Health and Safety Code; |
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157 | 157 | | (13) a regional or local health care program operated |
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158 | 158 | | under Section 75.104, Health and Safety Code; |
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159 | 159 | | (14) a self-funded health benefit plan sponsored by a |
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160 | 160 | | professional employer organization under Chapter 91, Labor Code; |
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161 | 161 | | (15) county employee group health benefits provided |
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162 | 162 | | under Chapter 157, Local Government Code; and |
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163 | 163 | | (16) health and accident coverage provided by a risk |
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164 | 164 | | pool created under Chapter 172, Local Government Code. |
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165 | 165 | | Sec. 1369.703. PROHIBITION ON DISCRIMINATORY ACTIONS. A |
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166 | 166 | | health benefit plan issuer, pharmacy benefit manager, or |
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167 | 167 | | third-party payor may not: |
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168 | 168 | | (1) reimburse a covered entity or a pharmacist or |
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169 | 169 | | pharmacy that is under contract with the entity for a prescription |
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170 | 170 | | drug at a rate lower than the rate paid to a non-covered entity for |
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171 | 171 | | the same drug; |
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172 | 172 | | (2) require a covered entity or a pharmacy or |
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173 | 173 | | pharmacist under contract with the entity to include with a claim |
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174 | 174 | | for a prescription drug dispensed by the entity an identification, |
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175 | 175 | | billing modifier, attestation, or other indication that the drug is |
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176 | 176 | | a 340B drug in order to be processed or resubmitted; |
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177 | 177 | | (3) impose a term on a covered entity that differs from |
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178 | 178 | | the terms applied to non-covered entities on the basis that the |
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179 | 179 | | entity is a covered entity, including: |
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180 | 180 | | (A) a fee, chargeback, or other adjustment that |
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181 | 181 | | is not placed on non-covered entities; or |
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182 | 182 | | (B) a restriction or requirement regarding |
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183 | 183 | | participation in a health benefit plan issuer, pharmacy benefit |
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184 | 184 | | manager, or third-party payor network, including a requirement that |
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185 | 185 | | a covered entity enter into a contract with a specific pharmacy or |
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186 | 186 | | pharmacist; or |
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187 | 187 | | (4) discriminate against, create a restriction |
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188 | 188 | | applicable to, or impose an additional charge on a patient who |
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189 | 189 | | chooses to receive a prescription drug from a covered entity. |
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190 | 190 | | SECTION 3. (a) Section 431.416, Health and Safety Code, as |
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191 | 191 | | added by this Act, applies only to a prescription drug manufactured |
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192 | 192 | | on or after the effective date of this Act. |
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193 | 193 | | (b) Subchapter O, Chapter 1369, Insurance Code, as added by |
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194 | 194 | | this Act, applies only to a health benefit plan delivered, issued |
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195 | 195 | | for delivery, or renewed on or after January 1, 2026. |
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196 | 196 | | SECTION 4. It is the intent of the legislature that every |
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197 | 197 | | provision, section, subsection, sentence, clause, phrase, or word |
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198 | 198 | | in this Act, and every application of the provisions in this Act to |
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199 | 199 | | every person, group of persons, or circumstances, is severable from |
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200 | 200 | | each other. If any application of any provision in this Act to any |
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201 | 201 | | person, group of persons, or circumstances is found by a court to be |
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202 | 202 | | invalid for any reason, the remaining applications of that |
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203 | 203 | | provision to all other persons and circumstances shall be severed |
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204 | 204 | | and may not be affected. |
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205 | 205 | | SECTION 5. This Act takes effect September 1, 2025. |
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