1 | 1 | | 81R11079 YDB-D |
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2 | 2 | | By: McClendon H.B. No. 2700 |
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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 the establishment of an electronic system for |
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8 | 8 | | monitoring controlled substances and for submitting prescription |
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9 | 9 | | drug orders; providing criminal penalties. |
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10 | 10 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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11 | 11 | | SECTION 1. Subtitle J, Title 3, Occupations Code, is |
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12 | 12 | | amended by adding Chapter 570 to read as follows: |
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13 | 13 | | CHAPTER 570. ELECTRONIC SYSTEM FOR MONITORING |
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14 | 14 | | CONTROLLED SUBSTANCES AND FOR SUBMITTING |
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15 | 15 | | PRESCRIPTION DRUG ORDERS |
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16 | 16 | | SUBCHAPTER A. GENERAL PROVISIONS |
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17 | 17 | | Sec. 570.001. DEFINITIONS. In this chapter: |
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18 | 18 | | (1) "Controlled substance" means a controlled |
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19 | 19 | | substance listed in Schedule II, III, IV, or V as established under |
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20 | 20 | | Subchapter B, Chapter 481, Health and Safety Code. |
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21 | 21 | | (2) "Electronic system" means the electronic system |
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22 | 22 | | for monitoring controlled substances and for submitting |
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23 | 23 | | prescription drug orders established under this chapter. |
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24 | 24 | | (3) "Practitioner" means a person authorized under the |
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25 | 25 | | laws of this state to prescribe or dispense a prescription drug or |
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26 | 26 | | device. |
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27 | 27 | | Sec. 570.002. RULES. The board may adopt the rules |
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28 | 28 | | necessary to implement this chapter. |
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29 | 29 | | Sec. 570.003. PROHIBITED FEES AND TAXES. The board may not |
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30 | 30 | | require a practitioner or a pharmacist to pay a fee or tax |
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31 | 31 | | specifically dedicated to the operation of the system. |
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32 | 32 | | Sec. 570.004. GIFTS AND GRANTS. The board may accept gifts |
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33 | 33 | | or grants from private individuals, foundations, or the federal |
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34 | 34 | | government for the purposes of this chapter. |
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35 | 35 | | [Sections 570.005-570.050 reserved for expansion] |
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36 | 36 | | SUBCHAPTER B. ELECTRONIC SYSTEM |
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37 | 37 | | Sec. 570.051. ESTABLISHMENT OF SYSTEM. The board shall |
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38 | 38 | | establish an electronic system for: |
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39 | 39 | | (1) tracking prescriptions for controlled substances; |
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40 | 40 | | (2) monitoring controlled substances that are |
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41 | 41 | | dispensed in this state by a practitioner or pharmacist or |
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42 | 42 | | dispensed to an address in this state by a pharmacy licensed in this |
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43 | 43 | | state; |
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44 | 44 | | (3) allowing a practitioner to generate and transmit a |
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45 | 45 | | prescription drug order for a prescription drug or device to a |
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46 | 46 | | pharmacy or pharmacist for dispensing; |
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47 | 47 | | (4) allowing a practitioner to have real-time Internet |
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48 | 48 | | access to data in the system for prescribing purposes and for |
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49 | 49 | | patient safety; and |
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50 | 50 | | (5) alerting the board or law enforcement agencies |
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51 | 51 | | when episodes of inappropriate activity are identified by the |
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52 | 52 | | system. |
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53 | 53 | | Sec. 570.052. DATA SUBMITTED TO BOARD. (a) Each pharmacy |
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54 | 54 | | and pharmacist licensed in this state that is authorized to |
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55 | 55 | | dispense a controlled substance in this state shall report to the |
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56 | 56 | | board the data required by this section in a timely manner as |
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57 | 57 | | prescribed by board rule, except that reporting may not be required |
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58 | 58 | | for: |
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59 | 59 | | (1) a drug administered directly to a patient; or |
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60 | 60 | | (2) a drug dispensed by a practitioner at a health care |
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61 | 61 | | facility licensed in this state, provided that the quantity |
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62 | 62 | | dispensed is limited to an amount adequate to treat the patient for |
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63 | 63 | | a maximum of 48 hours. |
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64 | 64 | | (b) Data for each controlled substance that is dispensed |
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65 | 65 | | must include the following: |
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66 | 66 | | (1) a patient identifier; |
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67 | 67 | | (2) the name of the drug dispensed; |
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68 | 68 | | (3) the date of dispensing; |
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69 | 69 | | (4) the quantity dispensed; |
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70 | 70 | | (5) the name of the practitioner who prescribed the |
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71 | 71 | | controlled substance; |
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72 | 72 | | (6) the name and address of the pharmacy or pharmacist |
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73 | 73 | | who dispensed the controlled substance; and |
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74 | 74 | | (7) any other information required by board rule. |
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75 | 75 | | (c) A pharmacy or pharmacist shall provide the data required |
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76 | 76 | | under Subsection (b) to the board in the electronic format |
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77 | 77 | | specified by board rule unless a waiver has been granted by the |
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78 | 78 | | board to an individual pharmacy or pharmacist. |
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79 | 79 | | (d) The board shall establish acceptable error tolerance |
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80 | 80 | | rates for data submitted under this section. A pharmacy or |
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81 | 81 | | pharmacist who submits the data shall ensure that reports fall |
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82 | 82 | | within the acceptable tolerances. |
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83 | 83 | | (e) A pharmacy or pharmacist who submits incomplete or |
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84 | 84 | | inaccurate data shall correct the data on notification by the board |
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85 | 85 | | if the pharmacy or pharmacist exceeds the acceptable error |
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86 | 86 | | tolerance rates established by the board. |
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87 | 87 | | Sec. 570.053. DISCLOSURE OF DATA. (a) The board may |
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88 | 88 | | disclose data obtained under this chapter only to persons and |
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89 | 89 | | entities authorized to receive that data under this chapter. |
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90 | 90 | | Disclosure to any other person or entity, including disclosure in |
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91 | 91 | | the context of a civil action in which the disclosure is sought |
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92 | 92 | | either for the purpose of discovery or for evidence, is prohibited |
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93 | 93 | | unless specifically authorized by this chapter. |
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94 | 94 | | (b) The board may provide data obtained under this chapter, |
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95 | 95 | | or a report containing or summarizing that data, to: |
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96 | 96 | | (1) a designated representative of a board that is |
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97 | 97 | | responsible for the licensure, regulation, or discipline of |
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98 | 98 | | practitioners, pharmacists, or other persons who are authorized to |
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99 | 99 | | prescribe, administer, or dispense controlled substances and that |
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100 | 100 | | is involved in a bona fide specific investigation involving a |
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101 | 101 | | designated person; |
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102 | 102 | | (2) a peace officer licensed in this state, a |
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103 | 103 | | certified or full-time peace officer of another state, or a federal |
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104 | 104 | | peace officer whose duty is to enforce the laws of this state, of |
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105 | 105 | | another state, or of the United States relating to drugs and who is |
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106 | 106 | | engaged in a bona fide specific investigation involving a |
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107 | 107 | | designated person; |
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108 | 108 | | (3) a state-operated Medicaid program; |
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109 | 109 | | (4) a properly convened grand jury pursuant to a |
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110 | 110 | | subpoena properly issued for the data; |
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111 | 111 | | (5) a practitioner or pharmacist who requests |
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112 | 112 | | information and certifies that the requested information is for the |
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113 | 113 | | purpose of providing medical or pharmaceutical treatment to a bona |
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114 | 114 | | fide current patient; |
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115 | 115 | | (6) the Texas Medical Board for any physician who is: |
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116 | 116 | | (A) associated in a partnership or other business |
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117 | 117 | | entity with a physician who is already under investigation by the |
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118 | 118 | | Texas Medical Board for improper prescribing practices; |
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119 | 119 | | (B) located in a designated geographic area for |
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120 | 120 | | which a trend report indicates a substantial likelihood that |
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121 | 121 | | inappropriate prescribing may be occurring in that area; or |
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122 | 122 | | (C) located in a designated geographic area for |
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123 | 123 | | which a report on another physician in that area indicates a |
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124 | 124 | | substantial likelihood that inappropriate prescribing may be |
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125 | 125 | | occurring in that area; |
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126 | 126 | | (7) the Texas Board of Nursing, for any advanced |
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127 | 127 | | registered nurse practitioner who is: |
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128 | 128 | | (A) associated in a partnership or other business |
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129 | 129 | | entity with a physician who is already under investigation by the |
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130 | 130 | | Texas Medical Board for improper prescribing practices; |
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131 | 131 | | (B) associated in a partnership or other business |
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132 | 132 | | entity with an advanced registered nurse practitioner who is |
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133 | 133 | | already under investigation by the Texas Board of Nursing for |
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134 | 134 | | improper prescribing practices; |
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135 | 135 | | (C) located in a designated geographic area for |
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136 | 136 | | which a trend report indicates a substantial likelihood that |
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137 | 137 | | inappropriate prescribing may be occurring in that area; or |
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138 | 138 | | (D) located in a designated geographic area for |
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139 | 139 | | which a report on a physician or another advanced registered nurse |
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140 | 140 | | practitioner in that area indicates a substantial likelihood that |
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141 | 141 | | inappropriate prescribing may be occurring in that area; or |
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142 | 142 | | (8) a judge or a probation or parole officer |
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143 | 143 | | administering a diversion or probation program of a criminal |
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144 | 144 | | defendant arising out of a violation of this chapter or of a |
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145 | 145 | | criminal defendant who is documented by the court as a substance |
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146 | 146 | | abuser who is eligible to participate in a court-ordered drug |
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147 | 147 | | diversion or probation program. |
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148 | 148 | | (c) The Health and Human Services Commission may use any |
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149 | 149 | | data or reports from the system to identify Medicaid recipients |
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150 | 150 | | whose use of controlled substances may be appropriately managed by |
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151 | 151 | | a single outpatient pharmacy or primary care physician. |
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152 | 152 | | (d) A person who receives data or any report of the system |
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153 | 153 | | from the board may not provide it to any other person or entity |
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154 | 154 | | except by order of a court and only to a person or entity authorized |
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155 | 155 | | to receive the data or the report under this section, except as |
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156 | 156 | | provided by Subsections (e) and (f). |
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157 | 157 | | (e) A peace officer specified in Subsection (b)(2) who is |
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158 | 158 | | authorized to receive data or a report may share that information |
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159 | 159 | | with other peace officers specified in that subsection who are |
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160 | 160 | | authorized to receive data or a report if the peace officers are |
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161 | 161 | | working on a bona fide specific investigation involving a |
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162 | 162 | | designated person. The person providing and the person receiving |
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163 | 163 | | the data or report under this subsection must document in writing |
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164 | 164 | | each person to whom or by whom the data or report has been given or |
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165 | 165 | | received and the day, month, and year that the data or report has |
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166 | 166 | | been given or received. This document must be maintained in a file |
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167 | 167 | | by each law enforcement agency engaged in the investigation. |
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168 | 168 | | (f) A representative of the Health and Human Services |
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169 | 169 | | Commission may: |
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170 | 170 | | (1) share data or reports regarding overutilization by |
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171 | 171 | | Medicaid recipients with a board described by Subsection (b)(1) or |
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172 | 172 | | with a peace officer specified in Subsection (b)(2); and |
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173 | 173 | | (2) submit the data as evidence in an administrative |
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174 | 174 | | hearing held in accordance with Chapter 2001, Government Code. |
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175 | 175 | | (g) The board, all peace officers specified in Subsection |
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176 | 176 | | (b)(2), all officers of the court, and all regulatory agencies and |
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177 | 177 | | officers, in using the data for investigative or prosecution |
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178 | 178 | | purposes, shall consider the nature of the practitioner's and |
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179 | 179 | | pharmacist's practice and the condition for which the patient is |
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180 | 180 | | being treated. |
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181 | 181 | | (h) The data and any report obtained from the data may not be |
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182 | 182 | | a public record, except that the Health and Human Services |
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183 | 183 | | Commission may submit the data as evidence in an administrative |
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184 | 184 | | hearing held in accordance with Chapter 2001, Government Code. |
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185 | 185 | | Sec. 570.054. LIMITATIONS ON DATA IN SYSTEM; ARCHIVE. (a) |
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186 | 186 | | The board may limit the length of time that data remains in the |
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187 | 187 | | electronic system. |
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188 | 188 | | (b) Any data removed from the electronic system must be |
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189 | 189 | | archived and subject to retrieval within a reasonable time after a |
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190 | 190 | | request from a person authorized to review data under this section. |
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191 | 191 | | Sec. 570.055. COOPERATION OF STATE AGENCIES ON CONTINUING |
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192 | 192 | | EDUCATION. (a) The board shall work with each board responsible |
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193 | 193 | | for the licensure, regulation, or discipline of practitioners or |
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194 | 194 | | other persons who are authorized to prescribe, administer, or |
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195 | 195 | | dispense controlled substances for the development of a continuing |
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196 | 196 | | education program about the purposes and uses of the electronic |
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197 | 197 | | system for monitoring established under this chapter. |
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198 | 198 | | (b) The board shall work with the State Bar of Texas for the |
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199 | 199 | | development of a continuing education program for attorneys about |
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200 | 200 | | the purposes and uses of the electronic system established under |
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201 | 201 | | this chapter. |
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202 | 202 | | (c) The board shall work with the Commission on Law |
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203 | 203 | | Enforcement Officer Standards and Education for the development of |
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204 | 204 | | a continuing education program for peace officers about the |
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205 | 205 | | purposes and uses of the electronic system established under this |
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206 | 206 | | chapter. |
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207 | 207 | | [Sections 570.056-570.100 reserved for expansion] |
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208 | 208 | | SUBCHAPTER C. CRIMINAL PENALTIES |
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209 | 209 | | Sec. 570.101. CRIMINAL PENALTIES. (a) A pharmacist or |
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210 | 210 | | owner of a pharmacy that intentionally fails to transmit to the |
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211 | 211 | | board the data required by Section 570.052 commits an offense. An |
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212 | 212 | | offense under this subsection is a Class A misdemeanor for the first |
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213 | 213 | | offense and a state jail felony for each subsequent offense. |
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214 | 214 | | (b) A person who violates Section 570.053 commits an |
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215 | 215 | | offense. An offense under this subsection is a state jail felony |
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216 | 216 | | for the first offense and a third degree felony for each subsequent |
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217 | 217 | | offense. |
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218 | 218 | | SECTION 2. (a) An advisory committee is created to advise |
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219 | 219 | | the Texas State Board of Pharmacy on the implementation of Chapter |
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220 | 220 | | 570, Occupations Code, as added by this Act. |
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221 | 221 | | (b) The advisory committee is composed of: |
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222 | 222 | | (1) the executive director of the Texas State Board of |
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223 | 223 | | Pharmacy or the executive director's designee; |
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224 | 224 | | (2) a physician appointed by the governor; |
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225 | 225 | | (3) a pharmacist appointed by the governor; |
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226 | 226 | | (4) a physician appointed by the lieutenant governor; |
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227 | 227 | | (5) a pharmacist appointed by the lieutenant governor; |
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228 | 228 | | (6) a physician appointed by the governor from a list |
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229 | 229 | | of names submitted by the speaker of the house of representatives; |
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230 | 230 | | (7) a pharmacist appointed by the governor from a list |
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231 | 231 | | of names submitted by the speaker of the house of representatives; |
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232 | 232 | | and |
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233 | 233 | | (8) one member from each of the following boards: |
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234 | 234 | | (A) Texas Medical Board; |
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235 | 235 | | (B) Texas State Board of Pharmacy; |
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236 | 236 | | (C) State Board of Dental Examiners; and |
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237 | 237 | | (D) Texas Board of Nursing. |
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238 | 238 | | (c) The executive director of the Texas State Board of |
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239 | 239 | | Pharmacy or the executive director's designee is the presiding |
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240 | 240 | | officer of the advisory committee. The committee shall meet at the |
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241 | 241 | | call of the presiding officer or at the request of any three members |
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242 | 242 | | other than the presiding officer. |
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243 | 243 | | (d) The advisory committee shall: |
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244 | 244 | | (1) develop recommendations regarding the improvement |
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245 | 245 | | of the official prescription program established by Section |
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246 | 246 | | 481.075, Health and Safety Code; |
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247 | 247 | | (2) develop recommendations regarding the |
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248 | 248 | | implementation of the electronic system for monitoring controlled |
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249 | 249 | | substances established under Chapter 570, Occupations Code; |
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250 | 250 | | (3) develop recommendations on the data that should be |
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251 | 251 | | provided to the Texas State Board of Pharmacy to support the |
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252 | 252 | | electronic system for monitoring controlled substances, including |
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253 | 253 | | provider identification information; |
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254 | 254 | | (4) monitor and develop recommendations regarding the |
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255 | 255 | | implementation and enforcement of the electronic system for |
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256 | 256 | | monitoring controlled substances; |
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257 | 257 | | (5) develop recommended procedures necessary for |
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258 | 258 | | real-time point-of-service access for a practitioner authorized to |
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259 | 259 | | prescribe or dispense controlled substances listed in Schedules II |
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260 | 260 | | through V so that the practitioner may obtain: |
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261 | 261 | | (A) the prescription history for a particular |
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262 | 262 | | patient; or |
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263 | 263 | | (B) the practitioner's own dispensing or |
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264 | 264 | | prescribing activity; and |
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265 | 265 | | (6) develop recommended procedures that should be |
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266 | 266 | | followed by the Texas State Board of Pharmacy and the applicable |
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267 | 267 | | licensing authority of this state, another state, or the United |
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268 | 268 | | States when: |
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269 | 269 | | (A) the board shares information related to |
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270 | 270 | | diversion of controlled substances with a licensing authority for |
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271 | 271 | | the purpose of licensing enforcement; or |
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272 | 272 | | (B) a licensing authority shares information |
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273 | 273 | | related to diversion of controlled substances with the board for |
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274 | 274 | | the purpose of criminal enforcement. |
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275 | 275 | | (e) The executive director of the Texas State Board of |
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276 | 276 | | Pharmacy shall report the recommendations developed under |
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277 | 277 | | Subsection (d) of this section to the governor, lieutenant |
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278 | 278 | | governor, speaker of the house of representatives, and appropriate |
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279 | 279 | | committees of the senate and the house of representatives not later |
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280 | 280 | | than July 1, 2010. |
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281 | 281 | | (f) This section expires and the advisory committee is |
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282 | 282 | | abolished September 1, 2011. |
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283 | 283 | | SECTION 3. The executive director of the Texas State Board |
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284 | 284 | | of Pharmacy or the executive director's designee shall adopt any |
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285 | 285 | | rules necessary to administer and enforce Chapter 570, Occupations |
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286 | 286 | | Code, as added by this Act, not later than January 1, 2010. |
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287 | 287 | | SECTION 4. (a) Except as provided by Subsection (b) of |
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288 | 288 | | this section, this Act takes effect September 1, 2009. |
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289 | 289 | | (b) Subchapter C, Chapter 570, Occupations Code, as added by |
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290 | 290 | | this Act, takes effect September 1, 2010. |
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