1 | 1 | | II |
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2 | 2 | | 119THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION S. 755 |
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5 | 5 | | To facilitate the development of treatments for cancers, and for other |
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6 | 6 | | purposes. |
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7 | 7 | | IN THE SENATE OF THE UNITED STATES |
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8 | 8 | | FEBRUARY26, 2025 |
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9 | 9 | | Mr. W |
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10 | 10 | | ICKER(for himself and Ms. KLOBUCHAR) introduced the following bill; |
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11 | 11 | | which was read twice and referred to the Committee on Finance |
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12 | 12 | | A BILL |
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13 | 13 | | To facilitate the development of treatments for cancers, and |
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14 | 14 | | for other purposes. |
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15 | 15 | | Be it enacted by the Senate and House of Representa-1 |
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16 | 16 | | tives of the United States of America in Congress assembled, 2 |
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17 | 17 | | SECTION 1. SHORT TITLE. 3 |
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18 | 18 | | This Act may be cited as the ‘‘Finn Sawyer Access 4 |
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19 | 19 | | to Cancer Testing Act’’. 5 |
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20 | 20 | | SEC. 2. COVERAGE OF CANCER DIAGNOSTIC AND LABORA-6 |
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21 | 21 | | TORY TESTS. 7 |
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22 | 22 | | (a) M |
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23 | 23 | | EDICARE.— 8 |
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24 | 24 | | (1) C |
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25 | 25 | | OVERAGE.—Section 1861 of the Social Se-9 |
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26 | 26 | | curity Act (42 U.S.C. 1395x) is amended— 10 |
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30 | 30 | | (A) in subsection (s)(2)— 1 |
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31 | 31 | | (i) in subparagraph (JJ), by adding 2 |
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32 | 32 | | ‘‘and’’ at the end; and 3 |
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33 | 33 | | (ii) by adding at the end the following 4 |
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34 | 34 | | new subparagraph: 5 |
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35 | 35 | | ‘‘(KK) cancer diagnostic and laboratory tests 6 |
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36 | 36 | | (as defined in subsection (nnn)) furnished on or 7 |
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37 | 37 | | after the date that is 6 months after the date of the 8 |
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38 | 38 | | enactment of this subparagraph.’’; and 9 |
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39 | 39 | | (B) by adding at the end the following new 10 |
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40 | 40 | | subsection: 11 |
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41 | 41 | | ‘‘(nnn) C |
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42 | 42 | | ANCERDIAGNOSTIC AND LABORATORY 12 |
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43 | 43 | | T |
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44 | 44 | | ESTS.— 13 |
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45 | 45 | | ‘‘(1) I |
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46 | 46 | | N GENERAL.—The term ‘cancer diag-14 |
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47 | 47 | | nostic and laboratory tests’ means— 15 |
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48 | 48 | | ‘‘(A) microarray analysis, DNA sequenc-16 |
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49 | 49 | | ing, RNA sequencing, whole-exome sequencing, 17 |
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50 | 50 | | and other forms of next-generation sequencing 18 |
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51 | 51 | | furnished and reported by a clinical laboratory 19 |
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52 | 52 | | (as defined in section 353(a) of the Public 20 |
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53 | 53 | | Health Service Act); and 21 |
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54 | 54 | | ‘‘(B) explanation and interpretation of any 22 |
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55 | 55 | | analysis or sequencing described in subpara-23 |
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56 | 56 | | graph (A); 24 |
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57 | 57 | | furnished to an individual diagnosed with cancer. 25 |
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60 | 60 | | •S 755 IS |
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61 | 61 | | ‘‘(2) FREQUENCY.—When an individual test as 1 |
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62 | 62 | | described in paragraph (1) reports out the same ge-2 |
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63 | 63 | | netic content, it may only be furnished with respect 3 |
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64 | 64 | | to an individual diagnosed with a cancer— 4 |
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65 | 65 | | ‘‘(A) once upon the diagnosis of such can-5 |
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66 | 66 | | cer; 6 |
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67 | 67 | | ‘‘(B) once upon any recurrence of such 7 |
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68 | 68 | | cancer; and 8 |
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69 | 69 | | ‘‘(C) as necessary for purposes of planning 9 |
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70 | 70 | | treatment or monitoring the progression of such 10 |
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71 | 71 | | cancer or the response of such cancer to treat-11 |
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72 | 72 | | ment.’’. 12 |
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73 | 73 | | (2) P |
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74 | 74 | | AYMENT.—Section 1833 of the Social Se-13 |
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75 | 75 | | curity Act (42 U.S.C. 1395l) is amended— 14 |
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76 | 76 | | (A) in subsection (a)(1)— 15 |
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77 | 77 | | (i) by striking ‘‘and’’ before ‘‘(HH)’’; 16 |
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78 | 78 | | and 17 |
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79 | 79 | | (ii) by inserting the following before 18 |
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80 | 80 | | the semicolon: ‘‘, and (II) with respect to 19 |
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81 | 81 | | cancer diagnostic and laboratory tests (as 20 |
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82 | 82 | | defined in section 1861(nnn)), the amount 21 |
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83 | 83 | | paid shall be an amount equal to 80 per-22 |
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84 | 84 | | cent (or 100 percent, in the case of such 23 |
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85 | 85 | | tests for which payment is made on an as-24 |
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86 | 86 | | signment-related basis) of the lesser of the 25 |
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89 | 89 | | •S 755 IS |
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90 | 90 | | actual charge for the test or the amount 1 |
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91 | 91 | | that would have been determined for such 2 |
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92 | 92 | | test under section 1834A had such test 3 |
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93 | 93 | | been a clinical diagnostic laboratory test;’’; 4 |
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94 | 94 | | and 5 |
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95 | 95 | | (B) in subsection (b)— 6 |
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96 | 96 | | (i) by striking ‘‘, and (13)’’ and in-7 |
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97 | 97 | | serting ‘‘(13)’’; and 8 |
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98 | 98 | | (ii) by striking ‘‘1861(n).’’ and insert-9 |
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99 | 99 | | ing ‘‘section 1861(n), and (14) such de-10 |
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100 | 100 | | ductible shall not apply with respect to 11 |
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101 | 101 | | cancer diagnostic and laboratory tests (as 12 |
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102 | 102 | | defined in section 1861(nnn))’’. 13 |
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103 | 103 | | (3) E |
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104 | 104 | | XCLUSION MODIFICATION .—Section 14 |
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105 | 105 | | 1862(a)(1) of the Social Security Act (42 U.S.C. 15 |
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106 | 106 | | 1395y(a)(1)) is amended— 16 |
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107 | 107 | | (A) in subparagraph (O), by striking 17 |
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108 | 108 | | ‘‘and’’ at the end; 18 |
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109 | 109 | | (B) in subparagraph (P), by striking the 19 |
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110 | 110 | | semicolon and inserting ‘‘, and’’; and 20 |
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111 | 111 | | (C) by adding at the end the following new 21 |
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112 | 112 | | subparagraph: 22 |
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113 | 113 | | ‘‘(Q) in the case of cancer diagnostic and lab-23 |
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114 | 114 | | oratory tests (as defined in section 1861(nnn)), 24 |
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118 | 118 | | which are performed more frequently than is covered 1 |
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119 | 119 | | under such section;’’. 2 |
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120 | 120 | | (b) M |
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121 | 121 | | EDICAID.— 3 |
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122 | 122 | | (1) I |
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123 | 123 | | NCLUSION AS MEDICAL ASSISTANCE .—Sec-4 |
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124 | 124 | | tion 1905(a) of the Social Security Act (42 U.S.C. 5 |
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125 | 125 | | 1396d(a)) is amended— 6 |
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126 | 126 | | (A) in paragraph (31), by striking ‘‘and’’ 7 |
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127 | 127 | | at the end; 8 |
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128 | 128 | | (B) by redesignating paragraph (32) as 9 |
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129 | 129 | | paragraph (33); and 10 |
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130 | 130 | | (C) by inserting after paragraph (31) the 11 |
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131 | 131 | | following new paragraph: 12 |
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132 | 132 | | ‘‘(32) cancer diagnostic and laboratory tests (as 13 |
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133 | 133 | | defined in section 1861(nnn)); and’’. 14 |
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134 | 134 | | (2) M |
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135 | 135 | | ANDATORY COVERAGE .—Section 15 |
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136 | 136 | | 1902(a)(10)(A) of such Act is amended, in the mat-16 |
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137 | 137 | | ter preceding clause (i), by striking ‘‘and (30)’’ and 17 |
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138 | 138 | | inserting ‘‘(30), and (32)’’. 18 |
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139 | 139 | | (3) I |
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140 | 140 | | NCLUSION IN BENCHMARK COVERAGE .— 19 |
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141 | 141 | | Section 1937(b)(5) of such Act is amended by in-20 |
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142 | 142 | | serting before the period at the end the following: ‘‘, 21 |
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143 | 143 | | and beginning January 1, 2027, coverage of cancer 22 |
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144 | 144 | | diagnostic and laboratory tests (as defined in section 23 |
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145 | 145 | | 1861(nnn))’’. 24 |
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146 | 146 | | (4) E |
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147 | 147 | | FFECTIVE DATE.— 25 |
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151 | 151 | | (A) IN GENERAL.—The amendments made 1 |
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152 | 152 | | by this section shall apply with respect to items 2 |
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153 | 153 | | and services furnished on or after January 1, 3 |
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154 | 154 | | 2027. 4 |
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155 | 155 | | (B) E |
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156 | 156 | | XEMPTION FOR STATE LEGISLA -5 |
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157 | 157 | | TION.—In the case of a State plan under title 6 |
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158 | 158 | | XIX of the Social Security Act (42 U.S.C. 1396 7 |
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159 | 159 | | et seq.), or waiver of such plan, that the Sec-8 |
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160 | 160 | | retary of Health and Human Services deter-9 |
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161 | 161 | | mines requires State legislation in order for the 10 |
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162 | 162 | | respective plan to meet any requirement im-11 |
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163 | 163 | | posed by amendments made by this section, the 12 |
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164 | 164 | | respective plan shall not be regarded as failing 13 |
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165 | 165 | | to comply with the requirements of such title 14 |
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166 | 166 | | solely on the basis of its failure to meet such 15 |
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167 | 167 | | an additional requirement before the first day 16 |
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168 | 168 | | of the first calendar quarter beginning after the 17 |
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169 | 169 | | close of the first regular session of the State 18 |
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170 | 170 | | legislature that begins after the date of the en-19 |
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171 | 171 | | actment of this Act. For purposes of the pre-20 |
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172 | 172 | | vious sentence, in the case of a State that has 21 |
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173 | 173 | | a 2-year legislative session, each year of the ses-22 |
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174 | 174 | | sion shall be considered to be a separate regular 23 |
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175 | 175 | | session of the State legislature. 24 |
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179 | 179 | | (c) CHIP.—Section 2103(c) of the Social Security 1 |
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180 | 180 | | Act (42 U.S.C. 1397cc(c)) is amended by adding at the 2 |
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181 | 181 | | end the following new paragraph: 3 |
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182 | 182 | | ‘‘(13) C |
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183 | 183 | | OVERAGE OF CANCER DIAGNOSTIC AND 4 |
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184 | 184 | | LABORATORY TESTS.—Regardless of the type of cov-5 |
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185 | 185 | | erage elected by a State under subsection (a), begin-6 |
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186 | 186 | | ning January 1, 2025 child health assistance pro-7 |
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187 | 187 | | vided under such coverage for targeted low-income 8 |
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188 | 188 | | children and, in the case that the State elects to pro-9 |
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189 | 189 | | vide pregnancy-related assistance under such cov-10 |
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190 | 190 | | erage pursuant to section 2112, such pregnancy-re-11 |
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191 | 191 | | lated assistance for targeted low-income pregnant 12 |
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192 | 192 | | women (as defined in section 2112(d)), shall include 13 |
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193 | 193 | | coverage of cancer diagnostic and laboratory tests 14 |
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194 | 194 | | (as defined in section 1861(nnn)).’’. 15 |
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195 | 195 | | SEC. 3. EDUCATION AND AWARENESS PROGRAM ON 16 |
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196 | 196 | | GENOMIC TESTING. 17 |
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197 | 197 | | (a) I |
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198 | 198 | | NGENERAL.—The Secretary of Health and 18 |
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199 | 199 | | Human Services, in coordination with the Director of the 19 |
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200 | 200 | | National Human Genome Research Institute, shall carry 20 |
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201 | 201 | | out an education and awareness program for physicians 21 |
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202 | 202 | | and the general public on what genomic testing is, how 22 |
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203 | 203 | | it can be used, and the role of genetic counselors. 23 |
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204 | 204 | | (b) C |
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205 | 205 | | ANCER ANDMOLECULARDIAGNOSTICS.—The 24 |
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206 | 206 | | education and awareness program under subsection (a) 25 |
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210 | 210 | | shall encourage the inclusion in graduate medical edu-1 |
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211 | 211 | | cation and continuing medical education (including for 2 |
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212 | 212 | | specialty oncology services) of education and training on 3 |
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213 | 213 | | the importance of molecular diagnostics at diagnosis and 4 |
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214 | 214 | | reoccurrence of cancer to detect mutations. 5 |
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215 | 215 | | Æ |
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