1 | 1 | | 82R23747 YDB-F |
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2 | 2 | | By: Thompson, et al. H.B. No. 1809 |
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3 | 3 | | Substitute the following for H.B. No. 1809: |
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4 | 4 | | By: Kuempel C.S.H.B. No. 1809 |
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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 the registration of diagnostic imaging equipment, the |
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10 | 10 | | accreditation of diagnostic imaging facilities, and the regulation |
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11 | 11 | | of diagnostic imaging providers; providing penalties. |
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12 | 12 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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13 | 13 | | SECTION 1. Subtitle A, Title 3, Occupations Code, is |
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14 | 14 | | amended by adding Chapter 113 to read as follows: |
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15 | 15 | | CHAPTER 113. DIAGNOSTIC IMAGING |
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16 | 16 | | SUBCHAPTER A. GENERAL PROVISIONS |
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17 | 17 | | Sec. 113.001. DEFINITIONS. In this chapter: |
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18 | 18 | | (1) "Department" means the Department of State Health |
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19 | 19 | | Services. |
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20 | 20 | | (2) "Diagnostic imaging equipment" means a machine or |
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21 | 21 | | equipment used to provide a diagnostic imaging service to a |
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22 | 22 | | patient. |
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23 | 23 | | (3) "Diagnostic imaging facility" means any facility, |
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24 | 24 | | office, clinic, imaging center, hospital, or other location where a |
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25 | 25 | | diagnostic imaging service is provided to a patient for a fee. |
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26 | 26 | | (4) "Diagnostic imaging provider" means a health care |
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27 | 27 | | provider who performs a diagnostic imaging service on a patient for |
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28 | 28 | | a fee at a diagnostic imaging facility. |
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29 | 29 | | (5) "Diagnostic imaging service" means magnetic |
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30 | 30 | | resonance imaging, computed tomography, positron emission |
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31 | 31 | | tomography, or any hybrid technology that combines any of those |
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32 | 32 | | imaging modalities. |
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33 | 33 | | (6) "Health care provider" means a physician licensed |
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34 | 34 | | under Subtitle B, Title 3, or a nurse licensed under Subtitle E, |
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35 | 35 | | Title 3. |
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36 | 36 | | (7) "Patient" means a person who receives a physical |
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37 | 37 | | examination, evaluation, diagnosis, or treatment from a health care |
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38 | 38 | | provider. |
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39 | 39 | | (8) "Referral" means a health care provider's request |
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40 | 40 | | for or ordering of a diagnostic imaging service for a patient. The |
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41 | 41 | | term does not include a request for or ordering of nondiagnostic |
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42 | 42 | | imaging obtained for the sole purpose of direct incorporation into |
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43 | 43 | | treatment planning systems in the delivery of radiation therapy. |
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44 | 44 | | Sec. 113.002. RULES. The executive commissioner of the |
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45 | 45 | | Health and Human Services Commission, on behalf of the department |
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46 | 46 | | and as necessary to protect the public health and safety, shall |
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47 | 47 | | adopt rules specifying the procedures health care providers and |
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48 | 48 | | diagnostic imaging providers must use to comply with this chapter. |
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49 | 49 | | Sec. 113.003. SAFETY STANDARDS. Notwithstanding any other |
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50 | 50 | | law, a person who operates a diagnostic imaging facility that is |
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51 | 51 | | registered under this chapter or is exempt from registration under |
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52 | 52 | | this chapter may adopt and enforce safety standards that conform to |
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53 | 53 | | the recommendations of the American College of Radiology's ACR |
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54 | 54 | | Guidance Document for Safe MR Practices as the document existed on |
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55 | 55 | | January 1, 2011, or a more current version of the document approved |
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56 | 56 | | by the department. |
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57 | 57 | | [Sections 113.004-113.050 reserved for expansion] |
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58 | 58 | | SUBCHAPTER B. REGISTRATION OF FACILITIES |
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59 | 59 | | Sec. 113.051. REGISTRATION REQUIRED. Except as provided by |
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60 | 60 | | Section 113.052, a person may not operate a diagnostic imaging |
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61 | 61 | | facility in this state without a diagnostic imaging facility |
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62 | 62 | | certificate of registration issued under this subchapter. |
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63 | 63 | | Sec. 113.052. EXEMPTIONS FROM REGISTRATION REQUIREMENT. |
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64 | 64 | | The following facilities are not required to be registered under |
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65 | 65 | | this chapter: |
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66 | 66 | | (1) a birthing center licensed under Chapter 244, |
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67 | 67 | | Health and Safety Code; |
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68 | 68 | | (2) a hospital licensed under Chapter 241, Health and |
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69 | 69 | | Safety Code; |
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70 | 70 | | (3) a hospital owned and operated by this state; |
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71 | 71 | | (4) a diagnostic imaging facility located within or |
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72 | 72 | | connected to a hospital described by Subdivision (2) or (3); |
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73 | 73 | | (5) a diagnostic imaging facility owned or operated by |
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74 | 74 | | a hospital described by Subdivision (2) or (3) that is: |
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75 | 75 | | (A) surveyed as a service of the hospital by an |
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76 | 76 | | organization that has been granted deeming authority as a national |
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77 | 77 | | accreditation program for hospitals by the Centers for Medicare and |
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78 | 78 | | Medicaid Services; or |
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79 | 79 | | (B) granted provider-based status by the Centers |
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80 | 80 | | for Medicare and Medicaid Services; and |
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81 | 81 | | (6) a diagnostic imaging facility that uses only |
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82 | 82 | | dedicated dental diagnostic technology, which may include |
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83 | 83 | | cone-beam computed tomography used only to obtain images of the |
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84 | 84 | | maxillofacial region. |
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85 | 85 | | Sec. 113.053. APPLICATION; ISSUANCE. (a) An applicant for |
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86 | 86 | | a diagnostic imaging facility certificate of registration shall |
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87 | 87 | | submit to the department an application on the form prescribed by |
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88 | 88 | | the department. |
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89 | 89 | | (b) The department shall issue a diagnostic imaging |
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90 | 90 | | facility certificate of registration to an applicant if: |
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91 | 91 | | (1) the applicant pays any required fee; and |
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92 | 92 | | (2) the department determines the applicant's facility |
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93 | 93 | | meets the accreditation requirements under Section 113.054 and |
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94 | 94 | | department rule. |
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95 | 95 | | Sec. 113.054. ACCREDITATION OF FACILITIES. (a) The |
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96 | 96 | | department may not issue a diagnostic imaging facility certificate |
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97 | 97 | | of registration to a person unless the person's diagnostic imaging |
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98 | 98 | | facility has been accredited by a nationally recognized |
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99 | 99 | | accreditation organization approved by the department. |
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100 | 100 | | (b) In approving accreditation organizations, the |
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101 | 101 | | department shall consider: |
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102 | 102 | | (1) the ability of the organization to conduct timely |
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103 | 103 | | reviews of accreditation applications; |
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104 | 104 | | (2) the organization's process for timely integration |
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105 | 105 | | of new technology into accreditation programs; |
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106 | 106 | | (3) whether the organization's criteria for |
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107 | 107 | | accreditation of diagnostic imaging facilities includes all of the |
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108 | 108 | | following: |
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109 | 109 | | (A) qualifications for health care providers and |
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110 | 110 | | medical personnel providing health care services at the facility; |
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111 | 111 | | (B) qualifications for and responsibilities of |
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112 | 112 | | medical directors, supervising health care providers, and |
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113 | 113 | | interpreting health care providers providing services at the |
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114 | 114 | | facility; |
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115 | 115 | | (C) procedures for ensuring that diagnostic |
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116 | 116 | | imaging equipment complies with established performance |
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117 | 117 | | specifications, such as an independent assessment of image quality |
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118 | 118 | | and dose and an annual survey by a medical physicist that includes |
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119 | 119 | | dose measurements; |
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120 | 120 | | (D) procedures for ensuring that the images |
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121 | 121 | | produced by the equipment are of diagnostic quality, including |
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122 | 122 | | through direct visual evaluation of representative images by a |
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123 | 123 | | physician trained in medical imaging; |
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124 | 124 | | (E) procedures for ensuring patient safety; and |
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125 | 125 | | (F) quality assurance reporting; and |
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126 | 126 | | (4) any other factors the department considers |
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127 | 127 | | necessary to protect the health and safety of facility patients and |
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128 | 128 | | the public. |
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129 | 129 | | (c) Notwithstanding Subsections (a) and (b), the department |
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130 | 130 | | shall issue a diagnostic imaging facility certificate of |
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131 | 131 | | registration to a person who operates a diagnostic imaging facility |
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132 | 132 | | accredited by a nationally recognized accreditation organization |
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133 | 133 | | accepted by the Centers for Medicare and Medicaid Services if the |
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134 | 134 | | department determines the organization's accreditation criteria |
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135 | 135 | | meet all department requirements. |
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136 | 136 | | Sec. 113.055. TERM; RENEWAL. (a) A diagnostic imaging |
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137 | 137 | | facility certificate of registration expires on the second |
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138 | 138 | | anniversary of the date of issuance. |
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139 | 139 | | (b) A person may renew a diagnostic imaging facility |
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140 | 140 | | certificate of registration by submitting to the department on the |
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141 | 141 | | form prescribed by the department a renewal application and any fee |
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142 | 142 | | required by the department. |
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143 | 143 | | [Sections 113.056-113.070 reserved for expansion] |
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144 | 144 | | SUBCHAPTER B-1. REPORTING AND DISCLOSURE OF HEALTH CARE PROVIDER |
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145 | 145 | | REFERRALS |
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146 | 146 | | Sec. 113.071. DEFINITIONS. In this subchapter: |
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147 | 147 | | (1) "Immediate family member" means a person's spouse, |
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148 | 148 | | child, child's spouse, grandchild, grandchild's spouse, parent, |
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149 | 149 | | parent-in-law, or sibling. |
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150 | 150 | | (2) "Investment interest" means: |
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151 | 151 | | (A) an equity or debt security issued by a |
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152 | 152 | | person, including: |
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153 | 153 | | (i) shares of stock in a corporation; |
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154 | 154 | | (ii) membership or other interest in a |
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155 | 155 | | company, including a limited liability company; |
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156 | 156 | | (iii) units or other interests in a |
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157 | 157 | | partnership, including a limited liability partnership; and |
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158 | 158 | | (iv) bonds, debentures, notes, or other |
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159 | 159 | | equity interests or debt instruments; and |
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160 | 160 | | (B) the rental or time sharing of imaging |
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161 | 161 | | equipment and office space in which a referring health care |
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162 | 162 | | provider receives a portion of the billing revenue. |
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163 | 163 | | (3) "Investor" means a person who directly or |
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164 | 164 | | indirectly holds a legal, beneficial ownership, or investment |
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165 | 165 | | interest, including an interest held through an immediate family |
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166 | 166 | | member, a trust, or another person related to the investor within |
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167 | 167 | | the meaning of "related to the provider" as defined by 42 C.F.R. |
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168 | 168 | | Section 413.17. |
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169 | 169 | | (4) "Licensing authority" means a department, board, |
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170 | 170 | | office, or other agency of this state that regulates a health care |
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171 | 171 | | provider subject to this chapter. |
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172 | 172 | | Sec. 113.072. REPORTING AND DISCLOSURE OF REFERRALS. A |
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173 | 173 | | health care provider making a referral for diagnostic imaging |
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174 | 174 | | services must: |
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175 | 175 | | (1) disclose in writing to the provider's patients the |
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176 | 176 | | provider's investment interest in the diagnostic imaging facility; |
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177 | 177 | | (2) advise the provider's patients that the patient |
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178 | 178 | | may choose to have another diagnostic imaging facility provide the |
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179 | 179 | | diagnostic imaging services; and |
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180 | 180 | | (3) obtain and record the patient's written consent |
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181 | 181 | | after the disclosure and before the diagnostic imaging services are |
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182 | 182 | | provided. |
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183 | 183 | | [Sections 113.073-113.100 reserved for expansion] |
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184 | 184 | | SUBCHAPTER C. CIVIL PENALTY |
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185 | 185 | | Sec. 113.101. CIVIL PENALTY. (a) A person who operates a |
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186 | 186 | | diagnostic imaging facility or a diagnostic imaging provider that |
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187 | 187 | | violates this chapter or rules adopted under this chapter is |
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188 | 188 | | subject to a civil penalty of not more than $1,000 for each |
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189 | 189 | | violation. |
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190 | 190 | | (b) The attorney general at the request of the department |
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191 | 191 | | shall bring an action to collect penalties under this section. In |
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192 | 192 | | the suit, the department and the attorney general each may recover |
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193 | 193 | | reasonable expenses incurred in obtaining the penalty, including: |
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194 | 194 | | (1) investigation and court costs; and |
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195 | 195 | | (2) reasonable attorney's fees, witness fees, and |
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196 | 196 | | deposition expenses. |
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197 | 197 | | (c) Expenses recovered by the department under this section |
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198 | 198 | | shall be deposited in a separate account outside the state treasury |
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199 | 199 | | to be used by the department in the enforcement of this chapter. |
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200 | 200 | | SECTION 2. (a) Not later than January 1, 2012, the |
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201 | 201 | | executive commissioner of the Health and Human Services Commission |
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202 | 202 | | shall adopt the rules necessary to implement Chapter 113, |
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203 | 203 | | Occupations Code, as added by this Act. |
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204 | 204 | | (b) Notwithstanding Chapter 113, Occupations Code, as added |
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205 | 205 | | by this Act, a person is not required to hold a diagnostic imaging |
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206 | 206 | | facility certificate of registration to operate a diagnostic |
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207 | 207 | | imaging facility until March 1, 2012. |
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208 | 208 | | SECTION 3. Subchapter B-1, Chapter 113, Occupations Code, |
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209 | 209 | | as added by this Act, applies only to a referral or diagnostic |
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210 | 210 | | imaging service that occurs on or after the effective date of this |
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211 | 211 | | Act. A referral or service that occurs before the effective date of |
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212 | 212 | | this Act is governed by the law as it existed immediately before the |
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213 | 213 | | effective date of this Act, and that law is continued in effect for |
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214 | 214 | | that purpose. |
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215 | 215 | | SECTION 4. This Act takes effect September 1, 2011. |
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