1 | 1 | | I |
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2 | 2 | | 119THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION H. R. 842 |
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5 | 5 | | To amend title XVIII of the Social Security Act to provide for Medicare |
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6 | 6 | | coverage of multi-cancer early detection screening tests. |
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7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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8 | 8 | | JANUARY31, 2025 |
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9 | 9 | | Mr. A |
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10 | 10 | | RRINGTON(for himself, Ms. SEWELL, Mr. HUDSON, Mr. RUIZ, Mrs. |
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11 | 11 | | M |
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12 | 12 | | ILLER-MEEKS, and Ms. KELLYof Illinois) introduced the following bill; |
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13 | 13 | | which was referred to the Committee on Energy and Commerce, and in |
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14 | 14 | | addition to the Committee on Ways and Means, for a period to be subse- |
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15 | 15 | | quently determined by the Speaker, in each case for consideration of such |
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16 | 16 | | provisions as fall within the jurisdiction of the committee concerned |
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17 | 17 | | A BILL |
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18 | 18 | | To amend title XVIII of the Social Security Act to provide |
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19 | 19 | | for Medicare coverage of multi-cancer early detection |
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20 | 20 | | screening tests. |
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21 | 21 | | Be it enacted by the Senate and House of Representa-1 |
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22 | 22 | | tives of the United States of America in Congress assembled, 2 |
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23 | 23 | | SECTION 1. SHORT TITLE. 3 |
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24 | 24 | | This Act may be cited as the ‘‘Nancy Gardner Sewell 4 |
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25 | 25 | | Medicare Multi-Cancer Early Detection Screening Cov-5 |
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26 | 26 | | erage Act’’. 6 |
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28 | 28 | | ssavage on LAPJG3WLY3PROD with BILLS 2 |
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29 | 29 | | •HR 842 IH |
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30 | 30 | | SEC. 2. MEDICARE COVERAGE OF MULTI-CANCER EARLY 1 |
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31 | 31 | | DETECTION SCREENING TESTS. 2 |
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32 | 32 | | (a) C |
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33 | 33 | | OVERAGE.—Section 1861 of the Social Security 3 |
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34 | 34 | | Act (42 U.S.C. 1395x) is amended— 4 |
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35 | 35 | | (1) in subsection (s)(2)— 5 |
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36 | 36 | | (A) by striking the semicolon at the end of 6 |
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37 | 37 | | subparagraph (JJ) and inserting ‘‘; and’’; and 7 |
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38 | 38 | | (B) by adding at the end the following new 8 |
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39 | 39 | | subparagraph: 9 |
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40 | 40 | | ‘‘(KK) multi-cancer early detection screen-10 |
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41 | 41 | | ing tests (as defined in subsection (nnn));’’; and 11 |
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42 | 42 | | (2) by adding at the end the following new sub-12 |
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43 | 43 | | section: 13 |
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44 | 44 | | ‘‘(nnn) M |
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45 | 45 | | ULTI-CANCEREARLYDETECTIONSCREEN-14 |
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46 | 46 | | INGTESTS.— 15 |
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47 | 47 | | ‘‘(1) I |
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48 | 48 | | N GENERAL.—The term ‘multi-cancer 16 |
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49 | 49 | | early detection screening test’ means a test fur-17 |
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50 | 50 | | nished to an individual for the concurrent detection 18 |
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51 | 51 | | of multiple cancer types across multiple organ sites 19 |
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52 | 52 | | on or after January 1, 2028, that— 20 |
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53 | 53 | | ‘‘(A) is cleared under section 510(k), clas-21 |
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54 | 54 | | sified under section 513(f)(2), or approved 22 |
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55 | 55 | | under section 515 of the Federal Food, Drug, 23 |
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56 | 56 | | and Cosmetic Act; 24 |
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57 | 57 | | ‘‘(B) is— 25 |
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59 | 59 | | ssavage on LAPJG3WLY3PROD with BILLS 3 |
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60 | 60 | | •HR 842 IH |
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61 | 61 | | ‘‘(i) a genomic sequencing blood or 1 |
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62 | 62 | | blood product test that includes the anal-2 |
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63 | 63 | | ysis of cell-free nucleic acids; or 3 |
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64 | 64 | | ‘‘(ii) a test based on samples of bio-4 |
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65 | 65 | | logical material that provides results com-5 |
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66 | 66 | | parable to those obtained with a test de-6 |
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67 | 67 | | scribed in clause (i), as determined by the 7 |
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68 | 68 | | Secretary; and 8 |
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69 | 69 | | ‘‘(C) the Secretary determines is— 9 |
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70 | 70 | | ‘‘(i) reasonable and necessary for the 10 |
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71 | 71 | | prevention or early detection of an illness 11 |
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72 | 72 | | or disability; and 12 |
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73 | 73 | | ‘‘(ii) appropriate for individuals enti-13 |
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74 | 74 | | tled to benefits under part A or enrolled 14 |
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75 | 75 | | under part B. 15 |
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76 | 76 | | ‘‘(2) NCD |
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77 | 77 | | PROCESS.—In making determina-16 |
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78 | 78 | | tions under paragraph (1)(C) regarding the coverage 17 |
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79 | 79 | | of a new test, the Secretary shall use the process for 18 |
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80 | 80 | | making national coverage determinations (as defined 19 |
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81 | 81 | | in section 1869(f)(1)(B)) under this title.’’. 20 |
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82 | 82 | | (b) P |
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83 | 83 | | AYMENT ANDSTANDARDS FOR MULTI-CANCER 21 |
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84 | 84 | | E |
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85 | 85 | | ARLYDETECTIONSCREENINGTESTS.— 22 |
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86 | 86 | | (1) I |
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87 | 87 | | N GENERAL.—Section 1834 of the Social 23 |
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88 | 88 | | Security Act (42 U.S.C. 1395m) is amended by add-24 |
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89 | 89 | | ing at the end the following new subsection: 25 |
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92 | 92 | | •HR 842 IH |
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93 | 93 | | ‘‘(aa) PAYMENT AND STANDARDS FOR MULTI-CAN-1 |
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94 | 94 | | CEREARLYDETECTIONSCREENINGTESTS.— 2 |
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95 | 95 | | ‘‘(1) P |
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96 | 96 | | AYMENT AMOUNT .—The payment 3 |
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97 | 97 | | amount for a multi-cancer early detection screening 4 |
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98 | 98 | | test (as defined in section 1861(nnn)) is— 5 |
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99 | 99 | | ‘‘(A) with respect to such a test furnished 6 |
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100 | 100 | | before January 1, 2031, equal to the payment 7 |
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101 | 101 | | amount in effect on the date of the enactment 8 |
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102 | 102 | | of this subsection for a multi-target stool 9 |
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103 | 103 | | screening DNA test covered pursuant to section 10 |
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104 | 104 | | 1861(pp)(1)(D); and 11 |
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105 | 105 | | ‘‘(B) with respect to such a test furnished 12 |
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106 | 106 | | on or after January 1, 2031, equal to the lesser 13 |
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107 | 107 | | of— 14 |
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108 | 108 | | ‘‘(i) the amount described in subpara-15 |
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109 | 109 | | graph (A); or 16 |
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110 | 110 | | ‘‘(ii) the payment amount determined 17 |
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111 | 111 | | for such test under section 1834A. 18 |
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112 | 112 | | ‘‘(2) L |
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113 | 113 | | IMITATIONS.— 19 |
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114 | 114 | | ‘‘(A) I |
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115 | 115 | | N GENERAL.—No payment may be 20 |
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116 | 116 | | made under this part for a multi-cancer early 21 |
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117 | 117 | | detection screening test furnished during a year 22 |
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118 | 118 | | to an individual if— 23 |
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121 | 121 | | •HR 842 IH |
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122 | 122 | | ‘‘(i) as of January 1 of such year, 1 |
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123 | 123 | | such individual has attained the age speci-2 |
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124 | 124 | | fied in subparagraph (B) for such year; or 3 |
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125 | 125 | | ‘‘(ii) such a test was furnished to the 4 |
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126 | 126 | | individual during the previous 11 months. 5 |
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127 | 127 | | ‘‘(B) A |
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128 | 128 | | GE SPECIFIED.—For purposes of 6 |
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129 | 129 | | subparagraph (A)(i), the age specified in this 7 |
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130 | 130 | | subparagraph is— 8 |
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131 | 131 | | ‘‘(i) for 2028, 68 years of age; and 9 |
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132 | 132 | | ‘‘(ii) for a succeeding year, the age 10 |
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133 | 133 | | specified in this subparagraph for the pre-11 |
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134 | 134 | | ceding year, increased by 1 year. 12 |
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135 | 135 | | ‘‘(3) S |
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136 | 136 | | TANDARDS FOLLOWING USPSTF RAT -13 |
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137 | 137 | | ING.—In the case of a multi-cancer early detection 14 |
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138 | 138 | | screening test that is recommended with a grade of 15 |
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139 | 139 | | A or B by the United States Preventive Services 16 |
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140 | 140 | | Task Force, beginning on the date on which cov-17 |
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141 | 141 | | erage for such test is provided pursuant to section 18 |
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142 | 142 | | 1861(ddd)(1), the preceding provisions of this sub-19 |
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143 | 143 | | section shall not apply.’’. 20 |
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144 | 144 | | (2) C |
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145 | 145 | | ONFORMING AMENDMENTS .— 21 |
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146 | 146 | | (A) Section 1833 of the Social Security 22 |
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147 | 147 | | Act (42 U.S.C. 1395l) is amended— 23 |
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148 | 148 | | (i) in subsection (a)— 24 |
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151 | 151 | | •HR 842 IH |
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152 | 152 | | (I) in paragraph (1)(D)(i)(I), by 1 |
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153 | 153 | | striking ‘‘section 1834(d)(1)’’ and in-2 |
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154 | 154 | | serting ‘‘subsection (d)(1) or (aa) of 3 |
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155 | 155 | | section 1834’’; and 4 |
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156 | 156 | | (II) in paragraph (2)(D)(i)(I), by 5 |
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157 | 157 | | striking ‘‘section 1834(d)(1)’’ and in-6 |
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158 | 158 | | serting ‘‘subsection (d)(1) or (aa) of 7 |
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159 | 159 | | section 1834’’; and 8 |
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160 | 160 | | (ii) in subsection (h), by striking ‘‘sec-9 |
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161 | 161 | | tion 1834(d)(1)’’ and inserting ‘‘sub-10 |
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162 | 162 | | sections (d)(1) and (aa) of section 1834’’. 11 |
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163 | 163 | | (B) Section 1862(a) of the Social Security 12 |
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164 | 164 | | Act (42 U.S.C. 1395y(a)) is amended— 13 |
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165 | 165 | | (i) in paragraph (1)— 14 |
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166 | 166 | | (I) in subparagraph (O), by 15 |
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167 | 167 | | striking ‘‘and’’ at the end; 16 |
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168 | 168 | | (II) in subparagraph (P), by 17 |
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169 | 169 | | striking the semicolon at the end and 18 |
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170 | 170 | | inserting ‘‘, and’’; and 19 |
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171 | 171 | | (III) by adding at the end the 20 |
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172 | 172 | | following new subparagraph: 21 |
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173 | 173 | | ‘‘(Q) in the case of multi-cancer early de-22 |
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174 | 174 | | tection screening tests (as defined in section 23 |
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175 | 175 | | 1861(nnn)), which are not reasonable and nec-24 |
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177 | 177 | | ssavage on LAPJG3WLY3PROD with BILLS 7 |
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178 | 178 | | •HR 842 IH |
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179 | 179 | | essary for the concurrent detection of multiple 1 |
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180 | 180 | | cancer types across multiple organ sites;’’; and 2 |
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181 | 181 | | (ii) in paragraph (7), by striking ‘‘or 3 |
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182 | 182 | | (P)’’ and inserting ‘‘(P), or (Q)’’. 4 |
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183 | 183 | | (c) R |
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184 | 184 | | ULE OFCONSTRUCTIONRELATING TOOTHER 5 |
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185 | 185 | | C |
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186 | 186 | | ANCERSCREENINGTESTS.—Nothing in this section, in-6 |
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187 | 187 | | cluding the amendments made by this section, shall be 7 |
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188 | 188 | | construed— 8 |
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189 | 189 | | (1) in the case of an individual who undergoes 9 |
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190 | 190 | | a multi-cancer early detection screening test, to af-10 |
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191 | 191 | | fect coverage under part B of title XVIII of the So-11 |
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192 | 192 | | cial Security Act for other cancer screening tests 12 |
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193 | 193 | | covered under such title, such as screening tests for 13 |
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194 | 194 | | breast, cervical, colorectal, lung, or prostate cancer; 14 |
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195 | 195 | | or 15 |
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196 | 196 | | (2) in the case of an individual who undergoes 16 |
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197 | 197 | | another cancer screening test, to affect coverage 17 |
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198 | 198 | | under such part for a multi-cancer early detection 18 |
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199 | 199 | | screening test or the use of such a test as a diag-19 |
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200 | 200 | | nostic or confirmatory test for a result of the other 20 |
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201 | 201 | | cancer screening test. 21 |
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202 | 202 | | Æ |
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