1 | 1 | | 81R9335 YDB-F |
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2 | 2 | | By: West S.B. No. 1706 |
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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 a program to provide prescribers |
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8 | 8 | | with evidence-based information about pharmaceuticals; assessing a |
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9 | 9 | | fee; providing 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. It is the intent of the legislature to ensure |
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12 | 12 | | that health care professionals have balanced and unbiased |
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13 | 13 | | evidence-based information readily available in order to ensure the |
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14 | 14 | | highest quality prescribing decisions are made for the citizens of |
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15 | 15 | | this state, which will improve health outcomes and reduce |
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16 | 16 | | unnecessary costs. |
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17 | 17 | | SECTION 2. Chapter 531, Government Code, is amended by |
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18 | 18 | | adding Subchapter Q to read as follows: |
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19 | 19 | | SUBCHAPTER Q. EVIDENCE-BASED PRESCRIBER EDUCATION SERVICE |
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20 | 20 | | Sec. 531.651. DEFINITIONS. In this subchapter: |
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21 | 21 | | (1) "Prescribed product" includes a drug or device as |
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22 | 22 | | defined in Section 201 of the Federal Food, Drug, and Cosmetic Act |
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23 | 23 | | (21 U.S.C. Section 321) and a biological product as defined in |
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24 | 24 | | Section 351 of the Public Health Service Act (42 U.S.C. Section |
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25 | 25 | | 262). |
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26 | 26 | | (2) "State health care program" means a program for |
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27 | 27 | | which the state purchases prescribed products, including the state |
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28 | 28 | | Medicaid program, a state pharmaceutical assistance program, or a |
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29 | 29 | | program for state employees and their dependents, individuals under |
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30 | 30 | | the supervision of corrections, or state retirees and their |
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31 | 31 | | dependents. |
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32 | 32 | | Sec. 531.652. ESTABLISHMENT OF EDUCATION SERVICE. (a) The |
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33 | 33 | | executive commissioner, in collaboration with an institution of |
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34 | 34 | | higher education in this state, shall develop an evidence-based |
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35 | 35 | | prescription education service designed to provide health care |
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36 | 36 | | professionals who are licensed to prescribe or dispense prescribed |
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37 | 37 | | products with information and education from a noncommercial source |
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38 | 38 | | on the comparative efficacy, safety, and cost-effectiveness of |
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39 | 39 | | commonly used prescribed products. |
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40 | 40 | | (b) In designing the service, the executive commissioner |
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41 | 41 | | shall consult with appropriate health care professionals or |
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42 | 42 | | organizations knowledgeable about the practice of medicine and |
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43 | 43 | | continuing medical education. |
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44 | 44 | | (c) The education service shall be geared toward assisting |
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45 | 45 | | health care professionals who are licensed to prescribe or dispense |
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46 | 46 | | prescribed products with making appropriate pharmaceutical |
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47 | 47 | | recommendations. |
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48 | 48 | | Sec. 531.653. REQUIREMENTS FOR EDUCATION SERVICE. (a) The |
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49 | 49 | | education service established by the executive commissioner under |
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50 | 50 | | Section 531.652 shall conduct in-person outreach and education |
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51 | 51 | | sessions that are: |
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52 | 52 | | (1) made available to health care professionals who |
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53 | 53 | | participate in, contract with, or are reimbursed by state-funded |
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54 | 54 | | health care programs; |
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55 | 55 | | (2) made available to health care professionals in |
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56 | 56 | | their place of work; |
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57 | 57 | | (3) facilitated by qualified and appropriately |
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58 | 58 | | trained clinician-educators; and |
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59 | 59 | | (4) conducted on a one-to-one basis, whenever |
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60 | 60 | | practicable. |
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61 | 61 | | (b) The service may also provide education to other health |
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62 | 62 | | care professionals as funding permits or for a fee. |
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63 | 63 | | (c) The educational materials used by the education service |
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64 | 64 | | must be based on a balanced, clinically relevant, and comprehensive |
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65 | 65 | | review of evidence that is accepted within the practice of |
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66 | 66 | | medicine, including scientific research that conforms to the |
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67 | 67 | | generally accepted standards of experimental design, data |
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68 | 68 | | collection, analysis, and interpretation with the purpose of |
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69 | 69 | | providing unbiased and objective continuing education on the |
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70 | 70 | | comparative efficacy, safety, and cost-effectiveness of |
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71 | 71 | | medications. |
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72 | 72 | | (d) The education service may use materials developed by a |
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73 | 73 | | medical school, an academic medical center, a school of pharmacy, a |
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74 | 74 | | medical society, a research institute, or another publicly |
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75 | 75 | | sponsored prescriber education service. |
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76 | 76 | | Sec. 531.654. RULES OF EDUCATION SERVICE. (a) The |
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77 | 77 | | executive commissioner shall adopt the rules necessary to implement |
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78 | 78 | | this subchapter. |
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79 | 79 | | (b) The rules adopted under this subchapter must establish: |
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80 | 80 | | (1) minimum clinical and educational qualifications |
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81 | 81 | | for prescriber educators employed by or under contract with the |
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82 | 82 | | education service; |
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83 | 83 | | (2) required training for educators; |
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84 | 84 | | (3) a code of conduct governing the behavior of |
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85 | 85 | | educators in their interactions with health care professionals; and |
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86 | 86 | | (4) conflict of interest guidelines for educators and |
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87 | 87 | | others involved in advising, developing, and administering the |
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88 | 88 | | service. |
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89 | 89 | | Sec. 531.655. FEE. (a) Each wholesale distributor of |
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90 | 90 | | prescription drugs that is licensed under Subchapter N, Chapter |
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91 | 91 | | 431, Health and Safety Code, that employs, directs, or utilizes one |
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92 | 92 | | or more prescription marketing representatives in this state to |
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93 | 93 | | market the distributor's prescription drugs shall pay to the |
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94 | 94 | | commission an annual fee in the amount of $2,500. |
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95 | 95 | | (b) The fee collected by the commission under this section |
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96 | 96 | | shall be deposited to the credit of the general revenue fund and may |
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97 | 97 | | be appropriated only for the education service established under |
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98 | 98 | | this subchapter. |
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99 | 99 | | (c) A wholesale distributor that fails to pay the fee |
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100 | 100 | | required by this section is subject to disciplinary action by the |
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101 | 101 | | Department of State Health Services under Section 431.414, Health |
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102 | 102 | | and Safety Code, as if the distributor violated Subchapter N, |
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103 | 103 | | Chapter 431, Health and Safety Code. |
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104 | 104 | | Sec. 531.656. COMMISSION DUTIES. The commission shall seek |
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105 | 105 | | and take all necessary actions to receive federal financial |
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106 | 106 | | participation for any academic detailing provided through the state |
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107 | 107 | | Medicaid program at the administrative matching rate of 50 percent. |
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108 | 108 | | Sec. 531.657. GIFTS AND GRANTS. The executive commissioner |
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109 | 109 | | may seek grants and financial gifts from nonprofit charitable |
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110 | 110 | | foundations to cover planning, development, and the ongoing |
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111 | 111 | | operation of the education service provided under this subchapter. |
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112 | 112 | | Sec. 531.658. REPORT. The executive commissioner shall |
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113 | 113 | | present an annual report on the development of the education |
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114 | 114 | | service to: |
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115 | 115 | | (1) the presiding officer of each house of the |
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116 | 116 | | legislature; and |
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117 | 117 | | (2) the chair of each committee in the legislature |
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118 | 118 | | with primary jurisdiction over the commission. |
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119 | 119 | | SECTION 3. (a) Not later than January 1, 2010, the |
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120 | 120 | | executive commissioner shall adopt the rules required by Subchapter |
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121 | 121 | | Q, Chapter 531, Government Code, as added by this Act. |
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122 | 122 | | (b) Not later than September 1, 2010, the executive |
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123 | 123 | | commissioner, in collaboration with an institution of higher |
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124 | 124 | | education in this state, shall establish the education service as |
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125 | 125 | | required by Subchapter Q, Chapter 531, Government Code, as added by |
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126 | 126 | | this Act. |
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127 | 127 | | (c) Notwithstanding Subchapter Q, Chapter 531, Government |
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128 | 128 | | Code, as added by this Act, a wholesale distributor is not required |
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129 | 129 | | to pay the fee required under Subchapter Q until January 1, 2010. |
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130 | 130 | | SECTION 4. This Act takes effect September 1, 2009. |
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