1 | 1 | | 81R97 DLF-D |
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2 | 2 | | By: Zaffirini, Van de Putte S.B. No. 39 |
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3 | 3 | | |
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4 | 4 | | |
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5 | 5 | | A BILL TO BE ENTITLED |
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6 | 6 | | AN ACT |
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7 | 7 | | relating to health benefit plan coverage for routine patient care |
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8 | 8 | | costs for enrollees participating in certain clinical trials. |
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9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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10 | 10 | | SECTION 1. Subtitle E, Title 8, Insurance Code, is amended |
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11 | 11 | | by adding Chapter 1379 to read as follows: |
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12 | 12 | | CHAPTER 1379. COVERAGE FOR ROUTINE PATIENT CARE COSTS FOR |
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13 | 13 | | ENROLLEES PARTICIPATING IN CERTAIN CLINICAL TRIALS |
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14 | 14 | | SUBCHAPTER A. GENERAL PROVISIONS |
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15 | 15 | | Sec. 1379.001. DEFINITIONS. In this chapter: |
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16 | 16 | | (1) "Enrollee" means an individual entitled to |
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17 | 17 | | coverage under a health benefit plan. |
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18 | 18 | | (2) "Life-threatening disease or condition" means a |
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19 | 19 | | disease or condition from which the likelihood of death is probable |
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20 | 20 | | unless the course of the disease or condition is interrupted. |
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21 | 21 | | (3) "Research institution" means the institution or |
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22 | 22 | | other person or entity conducting a phase I, phase II, phase III, or |
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23 | 23 | | phase IV clinical trial. |
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24 | 24 | | Sec. 1379.002. APPLICABILITY OF CHAPTER. (a) This chapter |
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25 | 25 | | applies only to a health benefit plan that provides benefits for |
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26 | 26 | | medical or surgical expenses incurred as a result of a health |
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27 | 27 | | condition, accident, or sickness, including an individual, group, |
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28 | 28 | | blanket, or franchise insurance policy or insurance agreement, a |
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29 | 29 | | group hospital service contract, or an individual or group evidence |
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30 | 30 | | of coverage or similar coverage document that is offered by: |
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31 | 31 | | (1) an insurance company; |
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32 | 32 | | (2) a group hospital service corporation operating |
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33 | 33 | | under Chapter 842; |
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34 | 34 | | (3) a fraternal benefit society operating under |
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35 | 35 | | Chapter 885; |
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36 | 36 | | (4) a stipulated premium company operating under |
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37 | 37 | | Chapter 884; |
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38 | 38 | | (5) an exchange operating under Chapter 942; |
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39 | 39 | | (6) a health maintenance organization operating under |
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40 | 40 | | Chapter 843; |
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41 | 41 | | (7) a multiple employer welfare arrangement that holds |
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42 | 42 | | a certificate of authority under Chapter 846; or |
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43 | 43 | | (8) an approved nonprofit health corporation that |
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44 | 44 | | holds a certificate of authority under Chapter 844. |
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45 | 45 | | (b) This chapter applies to group health coverage made |
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46 | 46 | | available by a school district in accordance with Section 22.004, |
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47 | 47 | | Education Code. |
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48 | 48 | | (c) Notwithstanding Section 172.014, Local Government Code, |
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49 | 49 | | or any other law, this chapter applies to health and accident |
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50 | 50 | | coverage provided by a risk pool created under Chapter 172, Local |
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51 | 51 | | Government Code. |
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52 | 52 | | (d) Notwithstanding any provision in Chapter 1551, 1575, |
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53 | 53 | | 1579, or 1601 or any other law, this chapter applies to: |
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54 | 54 | | (1) a basic coverage plan under Chapter 1551; |
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55 | 55 | | (2) a basic plan under Chapter 1575; |
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56 | 56 | | (3) a primary care coverage plan under Chapter 1579; |
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57 | 57 | | and |
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58 | 58 | | (4) basic coverage under Chapter 1601. |
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59 | 59 | | (e) Notwithstanding Section 1501.251 or any other law, this |
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60 | 60 | | chapter applies to coverage under a small employer health benefit |
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61 | 61 | | plan subject to Chapter 1501. |
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62 | 62 | | Sec. 1379.003. APPLICABILITY TO CERTAIN GOVERNMENT |
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63 | 63 | | PROGRAMS. To the extent allowed by federal law, the state Medicaid |
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64 | 64 | | program, and a managed care organization that contracts with the |
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65 | 65 | | Health and Human Services Commission to provide health care |
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66 | 66 | | services to Medicaid recipients through a managed care plan, shall |
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67 | 67 | | provide the benefits required under this chapter to a Medicaid |
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68 | 68 | | recipient. |
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69 | 69 | | Sec. 1379.004. EXCEPTION. This chapter does not apply to: |
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70 | 70 | | (1) a plan that provides coverage: |
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71 | 71 | | (A) for wages or payments in lieu of wages for a |
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72 | 72 | | period during which an employee is absent from work because of |
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73 | 73 | | sickness or injury; |
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74 | 74 | | (B) as a supplement to a liability insurance |
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75 | 75 | | policy; |
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76 | 76 | | (C) for credit insurance; |
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77 | 77 | | (D) only for dental or vision care; |
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78 | 78 | | (E) only for hospital expenses; or |
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79 | 79 | | (F) only for indemnity for hospital confinement; |
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80 | 80 | | (2) a Medicare supplemental policy as defined by |
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81 | 81 | | Section 1882(g)(1), Social Security Act (42 U.S.C. Section 1395ss); |
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82 | 82 | | (3) a workers' compensation insurance policy; |
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83 | 83 | | (4) medical payment insurance coverage provided under |
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84 | 84 | | a motor vehicle insurance policy; or |
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85 | 85 | | (5) a long-term care policy, including a nursing home |
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86 | 86 | | fixed indemnity policy, unless the commissioner determines that the |
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87 | 87 | | policy provides benefit coverage so comprehensive that the policy |
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88 | 88 | | is a health benefit plan as described by Section 1379.002. |
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89 | 89 | | Sec. 1379.005. RULES. The commissioner, in accordance with |
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90 | 90 | | Subchapter A, Chapter 36, may adopt rules to implement this |
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91 | 91 | | chapter. |
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92 | 92 | | [Sections 1379.006-1379.050 reserved for expansion] |
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93 | 93 | | SUBCHAPTER B. COVERAGE FOR ROUTINE PATIENT CARE COSTS |
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94 | 94 | | Sec. 1379.051. ROUTINE PATIENT CARE COSTS. For purposes of |
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95 | 95 | | this chapter, routine patient care costs means the costs of any |
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96 | 96 | | medically necessary health care service for which benefits are |
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97 | 97 | | provided under a health benefit plan, without regard to whether the |
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98 | 98 | | enrollee is participating in a clinical trial. Routine patient |
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99 | 99 | | care costs do not include: |
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100 | 100 | | (1) the cost of an investigational new drug or device |
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101 | 101 | | that is not approved for any indication by the United States Food |
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102 | 102 | | and Drug Administration, including a drug or device that is the |
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103 | 103 | | subject of the clinical trial; |
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104 | 104 | | (2) the cost of a service that is not a health care |
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105 | 105 | | service, regardless of whether the service is required in |
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106 | 106 | | connection with participation in a clinical trial; |
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107 | 107 | | (3) the cost of a service that is clearly inconsistent |
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108 | 108 | | with widely accepted and established standards of care for a |
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109 | 109 | | particular diagnosis; |
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110 | 110 | | (4) a cost associated with managing a clinical trial; |
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111 | 111 | | or |
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112 | 112 | | (5) the cost of a health care service that is |
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113 | 113 | | specifically excluded from coverage under a health benefit plan. |
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114 | 114 | | Sec. 1379.052. COVERAGE REQUIRED. A health benefit plan |
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115 | 115 | | issuer shall provide benefits for routine patient care costs to an |
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116 | 116 | | enrollee in connection with a phase I, phase II, phase III, or phase |
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117 | 117 | | IV clinical trial if the clinical trial is conducted in relation to |
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118 | 118 | | the prevention, detection, or treatment of a life-threatening |
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119 | 119 | | disease or condition and is approved by: |
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120 | 120 | | (1) the Centers for Disease Control and Prevention of |
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121 | 121 | | the United States Department of Health and Human Services; |
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122 | 122 | | (2) the National Institutes of Health; |
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123 | 123 | | (3) the United States Food and Drug Administration; |
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124 | 124 | | (4) the United States Department of Defense; |
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125 | 125 | | (5) the United States Department of Veterans Affairs; |
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126 | 126 | | or |
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127 | 127 | | (6) an institutional review board of an institution in |
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128 | 128 | | this state that has an agreement with the Office for Human Research |
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129 | 129 | | Protections of the United States Department of Health and Human |
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130 | 130 | | Services. |
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131 | 131 | | Sec. 1379.053. RESEARCH INSTITUTION. (a) A health benefit |
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132 | 132 | | plan issuer is not required to reimburse the research institution |
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133 | 133 | | conducting the clinical trial for the cost of routine patient care |
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134 | 134 | | provided through the research institution unless the research |
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135 | 135 | | institution, and each health care professional providing routine |
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136 | 136 | | patient care through the research institution, agrees to accept |
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137 | 137 | | reimbursement under the health benefit plan, at the rates that are |
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138 | 138 | | established under the plan, as payment in full for the routine |
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139 | 139 | | patient care provided in connection with the clinical trial. |
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140 | 140 | | (b) A health benefit plan issuer is not required to provide |
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141 | 141 | | benefits under this section for services that are a part of the |
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142 | 142 | | subject matter of the clinical trial and that are customarily paid |
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143 | 143 | | for by the research institution conducting the clinical trial. |
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144 | 144 | | Sec. 1379.054. LIMITATIONS ON COVERAGE. (a) |
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145 | 145 | | Notwithstanding Section 1379.053, this chapter does not require a |
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146 | 146 | | health benefit plan issuer to provide benefits for routine patient |
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147 | 147 | | care services provided outside of the plan's health care provider |
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148 | 148 | | network unless out-of-network benefits are otherwise provided |
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149 | 149 | | under the plan. |
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150 | 150 | | (b) This chapter does not require a health benefit plan |
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151 | 151 | | issuer to provide benefits for health care services provided |
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152 | 152 | | outside this state unless the health benefit plan otherwise |
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153 | 153 | | provides benefits for health care services provided outside this |
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154 | 154 | | state. |
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155 | 155 | | Sec. 1379.055. DEDUCTIBLE, COINSURANCE, AND COPAYMENT |
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156 | 156 | | REQUIREMENTS. The benefits required under this chapter may be made |
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157 | 157 | | subject to a deductible, coinsurance, or copayment requirement |
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158 | 158 | | comparable to other deductible, coinsurance, or copayment |
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159 | 159 | | requirements applicable under the health benefit plan. |
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160 | 160 | | Sec. 1379.056. CANCELLATION OR NONRENEWAL PROHIBITED. The |
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161 | 161 | | issuer of a health benefit plan may not cancel or refuse to renew |
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162 | 162 | | coverage under a plan solely because an enrollee in the plan |
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163 | 163 | | participates in a clinical trial described by Section 1379.052. |
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164 | 164 | | SECTION 2. Section 1506.151, Insurance Code, is amended by |
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165 | 165 | | adding Subsection (d) to read as follows: |
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166 | 166 | | (d) Coverage provided by the pool is subject to Chapter |
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167 | 167 | | 1379. |
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168 | 168 | | SECTION 3. This Act applies only to a health benefit plan |
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169 | 169 | | that is delivered, issued for delivery, or renewed on or after |
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170 | 170 | | January 1, 2010. A health benefit plan that is delivered, issued |
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171 | 171 | | for delivery, or renewed before January 1, 2010, is governed by the |
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172 | 172 | | law as it existed immediately before the effective date of this Act, |
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173 | 173 | | and that law is continued in effect for that purpose. |
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174 | 174 | | SECTION 4. This Act takes effect September 1, 2009. |
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