1 | 1 | | I |
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2 | 2 | | 118THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION H. R. 198 |
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5 | 5 | | To increase reporting requirements and transparency requirements in the |
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6 | 6 | | 340B Drug Pricing Program, and for other purposes. |
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7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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8 | 8 | | JANUARY9, 2023 |
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9 | 9 | | Mr. R |
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10 | 10 | | OSENDALEintroduced the following bill; which was referred to the Com- |
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11 | 11 | | mittee on Energy and Commerce, and in addition to the Committee on |
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12 | 12 | | Ways and Means, for a period to be subsequently determined by the |
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13 | 13 | | Speaker, in each case for consideration of such provisions as fall within |
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14 | 14 | | the jurisdiction of the committee concerned |
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15 | 15 | | A BILL |
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16 | 16 | | To increase reporting requirements and transparency require- |
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17 | 17 | | ments in the 340B Drug Pricing Program, and for other |
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18 | 18 | | purposes. |
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19 | 19 | | Be it enacted by the Senate and House of Representa-1 |
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20 | 20 | | tives of the United States of America in Congress assembled, 2 |
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21 | 21 | | SECTION 1. SHORT TITLE. 3 |
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22 | 22 | | This Act may be cited as the ‘‘Drug Pricing Trans-4 |
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23 | 23 | | parency and Accountability Act’’. 5 |
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25 | 25 | | kjohnson on DSK79L0C42PROD with BILLS 2 |
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26 | 26 | | •HR 198 IH |
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27 | 27 | | SEC. 2. MORATORIUM ON REGISTRATION OF NEW NON- 1 |
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28 | 28 | | RURAL SECTION 340B HOSPITALS. 2 |
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29 | 29 | | Section 340B(a) of the Public Health Service Act (42 3 |
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30 | 30 | | U.S.C. 256b(a)) is amended— 4 |
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31 | 31 | | (1) in paragraph (4)(L), by striking ‘‘A sub-5 |
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32 | 32 | | section (d) hospital’’ and inserting ‘‘Subject to para-6 |
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33 | 33 | | graph (11), a subsection (d) hospital’’; and 7 |
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34 | 34 | | (2) by adding at the end the following: 8 |
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35 | 35 | | ‘‘(11) M |
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36 | 36 | | ORATORIUM ON REGISTRATION OF CER -9 |
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37 | 37 | | TAIN HOSPITALS.—During the 2-year period begin-10 |
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38 | 38 | | ning on the date of the enactment of this para-11 |
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39 | 39 | | graph— 12 |
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40 | 40 | | ‘‘(A) an entity described in paragraph 13 |
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41 | 41 | | (4)(L) shall not be considered a covered entity 14 |
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42 | 42 | | under this section unless such entity was a cov-15 |
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43 | 43 | | ered entity on such date (as evidenced by the 16 |
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44 | 44 | | entity having been identified as a covered entity 17 |
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45 | 45 | | as of such date under the covered entity identi-18 |
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46 | 46 | | fication system established under subsection 19 |
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47 | 47 | | (d)(2)(B)(iv)); and 20 |
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48 | 48 | | ‘‘(B) no site shall be added to the covered 21 |
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49 | 49 | | entity identification system established under 22 |
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50 | 50 | | subsection (d)(2)(B)(iv) or be permitted to 23 |
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51 | 51 | | begin participating in the drug discount pro-24 |
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52 | 52 | | gram under this section, as a ‘child site’ or oth-25 |
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53 | 53 | | erwise, on the basis of association with a cov-26 |
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54 | 54 | | VerDate Sep 11 2014 00:06 Jan 20, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H198.IH H198 |
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55 | 55 | | kjohnson on DSK79L0C42PROD with BILLS 3 |
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56 | 56 | | •HR 198 IH |
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57 | 57 | | ered entity described in paragraph (4)(L) un-1 |
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58 | 58 | | less such site was identified as a child site as 2 |
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59 | 59 | | of December 31, 2020, under the system estab-3 |
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60 | 60 | | lished under subsection (d)(2)(B)(iv). 4 |
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61 | 61 | | ‘‘(12) R |
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62 | 62 | | EGULATIONS TO BE ISSUED DURING 5 |
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63 | 63 | | THE MORATORIUM PERIOD TO IMPLEMENT STATU -6 |
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64 | 64 | | TORY REQUIREMENTS CLARIFYING HOSPITAL ELIGI -7 |
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65 | 65 | | BILITY CRITERIA AND HOSPITAL CHILD SITE STAND -8 |
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66 | 66 | | ARDS AND ENHANCING HOSPITAL TRANSPARENCY .— 9 |
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67 | 67 | | ‘‘(A) I |
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68 | 68 | | SSUANCE OF REGULATIONS .— 10 |
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69 | 69 | | ‘‘(i) I |
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70 | 70 | | N GENERAL.—During the mora-11 |
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71 | 71 | | torium period under paragraph (11), the 12 |
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72 | 72 | | Secretary shall promulgate regulations 13 |
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73 | 73 | | through notice and comment rulemaking to 14 |
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74 | 74 | | implement the standards and requirements 15 |
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75 | 75 | | described in subparagraph (B). 16 |
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76 | 76 | | ‘‘(ii) D |
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77 | 77 | | EADLINE.—Such final regula-17 |
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78 | 78 | | tions shall be promulgated and take ef-18 |
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79 | 79 | | fect— 19 |
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80 | 80 | | ‘‘(I) before the end date of the 20 |
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81 | 81 | | moratorium described in paragraph 21 |
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82 | 82 | | (11); or 22 |
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83 | 83 | | ‘‘(II) in the event that any of 23 |
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84 | 84 | | such regulations have not taken effect 24 |
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85 | 85 | | by such end date, the moratorium 25 |
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87 | 87 | | kjohnson on DSK79L0C42PROD with BILLS 4 |
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88 | 88 | | •HR 198 IH |
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89 | 89 | | under subparagraph (11) shall be ex-1 |
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90 | 90 | | tended until such regulations are final 2 |
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91 | 91 | | and effective. 3 |
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92 | 92 | | ‘‘(iii) L |
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93 | 93 | | IMITATION.—The authority to 4 |
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94 | 94 | | promulgate regulations under this para-5 |
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95 | 95 | | graph is limited to setting forth the details 6 |
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96 | 96 | | necessary and appropriate to carry out the 7 |
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97 | 97 | | requirements of subparagraph (B) effi-8 |
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98 | 98 | | ciently, effectively, and in conformity with 9 |
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99 | 99 | | such subparagraph. 10 |
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100 | 100 | | ‘‘(B) S |
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101 | 101 | | TANDARDS AND REQUIREMENTS .— 11 |
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102 | 102 | | ‘‘(i) H |
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103 | 103 | | OSPITAL CHILD SITE STAND -12 |
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104 | 104 | | ARDS.— 13 |
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105 | 105 | | ‘‘(I) I |
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106 | 106 | | N GENERAL.—Hospitals de-14 |
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107 | 107 | | scribed in subparagraphs (L) and (M) 15 |
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108 | 108 | | of paragraph (4) may register off- 16 |
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109 | 109 | | campus outpatient facilities associated 17 |
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110 | 110 | | with the hospital (also known as ‘child 18 |
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111 | 111 | | sites’) to participate in the drug dis-19 |
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112 | 112 | | count program under this section (be-20 |
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113 | 113 | | ginning after the moratorium under 21 |
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114 | 114 | | paragraph (11) ends), if— 22 |
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115 | 115 | | ‘‘(aa) the site is listed on the 23 |
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116 | 116 | | hospital’s most recently filed 24 |
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117 | 117 | | Medicare cost report on a line 25 |
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119 | 119 | | kjohnson on DSK79L0C42PROD with BILLS 5 |
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120 | 120 | | •HR 198 IH |
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121 | 121 | | that is reimbursable under the 1 |
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122 | 122 | | Medicare program (or, if the hos-2 |
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123 | 123 | | pital is a children’s hospital that 3 |
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124 | 124 | | does not file a Medicare cost re-4 |
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125 | 125 | | port, the hospital submits to the 5 |
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126 | 126 | | Secretary a signed statement cer-6 |
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127 | 127 | | tifying that the facility would be 7 |
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128 | 128 | | correctly included on a reimburs-8 |
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129 | 129 | | able line of a Medicare cost re-9 |
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130 | 130 | | port if the hospital filed a cost 10 |
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131 | 131 | | report); 11 |
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132 | 132 | | ‘‘(bb) such cost report dem-12 |
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133 | 133 | | onstrates that the services pro-13 |
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134 | 134 | | vided at the facility have associ-14 |
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135 | 135 | | ated costs and charges for hos-15 |
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136 | 136 | | pital outpatient department serv-16 |
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137 | 137 | | ices under title XVIII of the So-17 |
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138 | 138 | | cial Security Act (or, if the hos-18 |
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139 | 139 | | pital is a children’s hospital that 19 |
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140 | 140 | | does not file a Medicare cost re-20 |
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141 | 141 | | port, the hospital submits to the 21 |
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142 | 142 | | Secretary a signed statement cer-22 |
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143 | 143 | | tifying that the services provided 23 |
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144 | 144 | | at the facility include or consist 24 |
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145 | 145 | | solely of outpatient services); 25 |
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147 | 147 | | kjohnson on DSK79L0C42PROD with BILLS 6 |
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148 | 148 | | •HR 198 IH |
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149 | 149 | | ‘‘(cc) the facility is wholly 1 |
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150 | 150 | | owned by the covered entity; 2 |
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151 | 151 | | ‘‘(dd) the Secretary has 3 |
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152 | 152 | | made a determination, under the 4 |
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153 | 153 | | process described in section 5 |
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154 | 154 | | 413.65(b) of title 42, Code of 6 |
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155 | 155 | | Federal Regulations (or any suc-7 |
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156 | 156 | | cessor regulations), that the facil-8 |
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157 | 157 | | ity meets the Medicare provider- 9 |
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158 | 158 | | based standards under section 10 |
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159 | 159 | | 413.65 of title 42, Code of Fed-11 |
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160 | 160 | | eral Regulations (or any suc-12 |
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161 | 161 | | cessor regulations); 13 |
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162 | 162 | | ‘‘(ee) the facility provides a 14 |
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163 | 163 | | full range of outpatient services, 15 |
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164 | 164 | | in addition to drugs; and 16 |
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165 | 165 | | ‘‘(ff) the facility adheres to 17 |
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166 | 166 | | the charity care policy and any 18 |
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167 | 167 | | sliding fee scale policy of the par-19 |
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168 | 168 | | ent hospital. 20 |
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169 | 169 | | ‘‘(II) D |
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170 | 170 | | E-REGISTRATION.—If at 21 |
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171 | 171 | | any time following registration one or 22 |
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172 | 172 | | more of the standards listed above are 23 |
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173 | 173 | | no longer satisfied, a registered hos-24 |
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174 | 174 | | pital shall immediately notify the Sec-25 |
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176 | 176 | | kjohnson on DSK79L0C42PROD with BILLS 7 |
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177 | 177 | | •HR 198 IH |
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178 | 178 | | retary, de-register the facility, and 1 |
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179 | 179 | | keep the facility from making any 2 |
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180 | 180 | | purchases under the drug discount 3 |
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181 | 181 | | program under this section or rep-4 |
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182 | 182 | | resenting to third parties that it may 5 |
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183 | 183 | | purchase under such program. 6 |
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184 | 184 | | ‘‘(ii) H |
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185 | 185 | | OSPITAL ELIGIBILITY STAND -7 |
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186 | 186 | | ARDS FOR HOSPITALS NOT OWNED OR OP -8 |
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187 | 187 | | ERATED BY A UNIT OF STATE OR LOCAL 9 |
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188 | 188 | | GOVERNMENT.—For purposes of subpara-10 |
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189 | 189 | | graph (L)(i) of paragraph (4): 11 |
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190 | 190 | | ‘‘(I) A private hospital has been 12 |
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191 | 191 | | formally granted governmental powers 13 |
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192 | 192 | | by a unit of State or local government 14 |
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193 | 193 | | if the Secretary receives a certification 15 |
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194 | 194 | | from a State or local governmental 16 |
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195 | 195 | | entity that such governmental entity 17 |
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196 | 196 | | has formally delegated, through State 18 |
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197 | 197 | | or local statute or regulation or, if 19 |
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198 | 198 | | permitted by applicable State or local 20 |
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199 | 199 | | law, through a contract with a State 21 |
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200 | 200 | | or local government, to the hospital 22 |
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201 | 201 | | such a power, described in detail in 23 |
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202 | 202 | | the certification. 24 |
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204 | 204 | | kjohnson on DSK79L0C42PROD with BILLS 8 |
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205 | 205 | | •HR 198 IH |
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206 | 206 | | ‘‘(II) A private hospital has a 1 |
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207 | 207 | | contract with a State or local govern-2 |
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208 | 208 | | ment to provide health care services to 3 |
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209 | 209 | | low-income individuals who are not 4 |
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210 | 210 | | entitled to benefits under Medicare or 5 |
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211 | 211 | | Medicaid if— 6 |
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212 | 212 | | ‘‘(aa) the hospital submits a 7 |
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213 | 213 | | copy of the contract to the Sec-8 |
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214 | 214 | | retary for review; 9 |
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215 | 215 | | ‘‘(bb) the Secretary deter-10 |
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216 | 216 | | mines that the contract creates 11 |
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217 | 217 | | an enforceable obligation for the 12 |
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218 | 218 | | hospital to provide direct medical 13 |
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219 | 219 | | care to low-income individuals in-14 |
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220 | 220 | | eligible for Medicare and Med-15 |
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221 | 221 | | icaid in an amount that rep-16 |
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222 | 222 | | resents at least 15 percent of the 17 |
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223 | 223 | | hospital’s total costs for all items 18 |
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224 | 224 | | and services furnished at such 19 |
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225 | 225 | | hospital; and 20 |
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226 | 226 | | ‘‘(cc) the contract is avail-21 |
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227 | 227 | | able to the public as part of the 22 |
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228 | 228 | | information describing the hos-23 |
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229 | 229 | | pital in the covered entity identi-24 |
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231 | 231 | | kjohnson on DSK79L0C42PROD with BILLS 9 |
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232 | 232 | | •HR 198 IH |
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233 | 233 | | fication system established under 1 |
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234 | 234 | | subsection (d)(2)(B)(iv). 2 |
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235 | 235 | | ‘‘(III) If at any time a hospital 3 |
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236 | 236 | | not owned or operated by a unit of 4 |
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237 | 237 | | State or local government no longer 5 |
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238 | 238 | | meets one or more requirements 6 |
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239 | 239 | | under subclause (I) or (II), the hos-7 |
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240 | 240 | | pital shall immediately notify the Sec-8 |
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241 | 241 | | retary, dis-enroll from the drug dis-9 |
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242 | 242 | | count program under this section, and 10 |
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243 | 243 | | stop making purchases under such 11 |
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244 | 244 | | program and representing to third 12 |
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245 | 245 | | parties that it may purchase under 13 |
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246 | 246 | | such program. 14 |
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247 | 247 | | ‘‘(iii) H |
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248 | 248 | | OSPITAL TRANSPARENCY RE -15 |
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249 | 249 | | QUIREMENTS.— 16 |
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250 | 250 | | ‘‘(I) H |
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251 | 251 | | OSPITAL REQUIREMENTS 17 |
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252 | 252 | | TO IDENTIFY SECTION 340B DRUGS .— 18 |
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253 | 253 | | In the case of covered entity hospitals 19 |
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254 | 254 | | described in subparagraph (L) of 20 |
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255 | 255 | | paragraph (4): 21 |
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256 | 256 | | ‘‘(aa) Claims for covered 22 |
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257 | 257 | | outpatient drugs purchased 23 |
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258 | 258 | | under the drug discount program 24 |
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259 | 259 | | under this section shall be sub-25 |
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260 | 260 | | VerDate Sep 11 2014 00:06 Jan 20, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H198.IH H198 |
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261 | 261 | | kjohnson on DSK79L0C42PROD with BILLS 10 |
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262 | 262 | | •HR 198 IH |
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263 | 263 | | mitted to public and private 1 |
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264 | 264 | | payors using the 340B modifier 2 |
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265 | 265 | | established by the Secretary 3 |
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266 | 266 | | under the prospective payment 4 |
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267 | 267 | | system for hospital outpatient de-5 |
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268 | 268 | | partment services, in conform-6 |
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269 | 269 | | ance with paragraph (22) of sec-7 |
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270 | 270 | | tion 1833(t) of the Social Secu-8 |
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271 | 271 | | rity Act, subsection (h) of 9 |
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272 | 272 | | 1847A, subparagraph (F) of sec-10 |
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273 | 273 | | tion 1927(a)(5), and paragraph 11 |
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274 | 274 | | (5) of section 1857(g), that is 12 |
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275 | 275 | | ‘JG’. 13 |
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276 | 276 | | ‘‘(bb) Such hospitals shall 14 |
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277 | 277 | | report to the Secretary on an an-15 |
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278 | 278 | | nual basis, in a form and manner 16 |
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279 | 279 | | specified by the Secretary— 17 |
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280 | 280 | | ‘‘(AA) the hospital’s ag-18 |
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281 | 281 | | gregate annual revenue from 19 |
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282 | 282 | | drugs purchased under the 20 |
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283 | 283 | | program under this section, 21 |
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284 | 284 | | minus its aggregate annual 22 |
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285 | 285 | | acquisition costs for such 23 |
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286 | 286 | | drugs, broken out by hos-24 |
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287 | 287 | | pital and by each child site; 25 |
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289 | 289 | | kjohnson on DSK79L0C42PROD with BILLS 11 |
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290 | 290 | | •HR 198 IH |
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291 | 291 | | ‘‘(BB) any dispensing 1 |
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292 | 292 | | fees paid by the hospital or 2 |
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293 | 293 | | child site to contract phar-3 |
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294 | 294 | | macies for such drugs; 4 |
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295 | 295 | | ‘‘(CC) the patient mix, 5 |
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296 | 296 | | broken down by expected 6 |
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297 | 297 | | payment source (including 7 |
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298 | 298 | | at least the Medicare pro-8 |
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299 | 299 | | gram under title XVIII of 9 |
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300 | 300 | | the Social Security Act, a 10 |
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301 | 301 | | State plan under the Med-11 |
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302 | 302 | | icaid program under title 12 |
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303 | 303 | | XIX of such Act, private in-13 |
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304 | 304 | | surance, and uninsured indi-14 |
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305 | 305 | | viduals), for each such hos-15 |
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306 | 306 | | pital, and each child site of 16 |
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307 | 307 | | the hospital listed in the 17 |
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308 | 308 | | covered entity information 18 |
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309 | 309 | | system established under 19 |
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310 | 310 | | subsection (d)(2)(B)(iv), and 20 |
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311 | 311 | | the costs incurred at each 21 |
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312 | 312 | | such hospital and site for 22 |
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313 | 313 | | charity care (as described in 23 |
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314 | 314 | | line 23 of Worksheet S– 24 |
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315 | 315 | | 10—Hospital Uncompen-25 |
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317 | 317 | | kjohnson on DSK79L0C42PROD with BILLS 12 |
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318 | 318 | | •HR 198 IH |
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319 | 319 | | sated and Indigent Care 1 |
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320 | 320 | | Data to the Medicare cost 2 |
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321 | 321 | | report or as reported in any 3 |
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322 | 322 | | successor form); 4 |
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323 | 323 | | ‘‘(DD) the percent of 5 |
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324 | 324 | | total revenues (net of any 6 |
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325 | 325 | | discounts) at each site de-7 |
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326 | 326 | | rived from infusion or injec-8 |
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327 | 327 | | tion of physician-adminis-9 |
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328 | 328 | | tered drugs, including any 10 |
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329 | 329 | | associated items or services 11 |
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330 | 330 | | furnished incident-to the ad-12 |
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331 | 331 | | ministration of such drugs; 13 |
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332 | 332 | | and 14 |
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333 | 333 | | ‘‘(EE) with respect to 15 |
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334 | 334 | | such hospital and each child 16 |
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335 | 335 | | site of the hospital, the 17 |
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336 | 336 | | names of all third-party ven-18 |
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337 | 337 | | dors or other similar entities 19 |
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338 | 338 | | (including split fee vendors 20 |
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339 | 339 | | and contract pharmacies) 21 |
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340 | 340 | | that the covered entity con-22 |
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341 | 341 | | tracts with to provide serv-23 |
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342 | 342 | | ices associated with the pro-24 |
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343 | 343 | | gram under this section 25 |
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345 | 345 | | kjohnson on DSK79L0C42PROD with BILLS 13 |
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346 | 346 | | •HR 198 IH |
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347 | 347 | | (broken down by covered en-1 |
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348 | 348 | | tity and by each child site). 2 |
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349 | 349 | | ‘‘(II) P |
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350 | 350 | | UBLIC AVAILABILITY.— 3 |
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351 | 351 | | The Secretary shall make the infor-4 |
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352 | 352 | | mation reported to the Secretary 5 |
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353 | 353 | | under subclause (I)(bb) available to 6 |
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354 | 354 | | the public (with redactions of any in-7 |
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355 | 355 | | formation the Secretary determines to 8 |
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356 | 356 | | be proprietary or confidential) in an 9 |
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357 | 357 | | annual compilation of the reported in-10 |
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358 | 358 | | formation available on the internet 11 |
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359 | 359 | | website of the Department of Health 12 |
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360 | 360 | | and Human Services, and as part of 13 |
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361 | 361 | | the information describing the hos-14 |
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362 | 362 | | pital and the relevant child site in the 15 |
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363 | 363 | | covered entity identification system 16 |
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364 | 364 | | established under subsection 17 |
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365 | 365 | | (d)(2)(B)(iv).’’. 18 |
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366 | 366 | | SEC. 3. 340B CLAIMS MODIFIER. 19 |
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367 | 367 | | (a) M |
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368 | 368 | | EDICAID.—Section 1927(a)(5) of the Social Se-20 |
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369 | 369 | | curity Act (42 U.S.C. 1396r–8(a)(5)) is amended by add-21 |
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370 | 370 | | ing at the end the following: 22 |
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371 | 371 | | ‘‘(F) 340B |
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372 | 372 | | CLAIMS MODIFIER.— 23 |
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373 | 373 | | ‘‘(i) I |
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374 | 374 | | N GENERAL.—All claims sub-24 |
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375 | 375 | | mitted to a Medicaid fee-for-service pro-25 |
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377 | 377 | | kjohnson on DSK79L0C42PROD with BILLS 14 |
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378 | 378 | | •HR 198 IH |
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379 | 379 | | gram or a medicaid managed care organi-1 |
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380 | 380 | | zation (as defined in section 2 |
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381 | 381 | | 1903(m)(1)(A)) for reimbursement of a 3 |
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382 | 382 | | unit of a covered outpatient drug subject 4 |
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383 | 383 | | to an agreement under section 340B of the 5 |
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384 | 384 | | Public Health Service Act shall include the 6 |
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385 | 385 | | 340B modifier established by the Secretary 7 |
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386 | 386 | | under the prospective payment system for 8 |
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387 | 387 | | hospital outpatient department services 9 |
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388 | 388 | | under section 1833(t) that is ‘JG’ or the 10 |
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389 | 389 | | Submission Clarification Code of ‘20’ de-11 |
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390 | 390 | | veloped by the National Council for Pre-12 |
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391 | 391 | | scription Drug Programs (NCPDP). 13 |
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392 | 392 | | ‘‘(ii) D |
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393 | 393 | | ATA SHARING.—Each single 14 |
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394 | 394 | | State agency shall make available to a 15 |
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395 | 395 | | manufacturer of a covered outpatient drug 16 |
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396 | 396 | | any fee-for-service or managed care claim 17 |
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397 | 397 | | for reimbursement for a unit of such drug 18 |
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398 | 398 | | for the purpose of verifying the propriety 19 |
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399 | 399 | | of any claim for a rebate payment under 20 |
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400 | 400 | | an agreement under subsection (b) with re-21 |
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401 | 401 | | spect to such drug. At the manufacturer’s 22 |
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402 | 402 | | request, in lieu of making such a claim 23 |
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403 | 403 | | available to the manufacturer, the single 24 |
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404 | 404 | | State agency may instead provide a list of 25 |
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406 | 406 | | kjohnson on DSK79L0C42PROD with BILLS 15 |
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407 | 407 | | •HR 198 IH |
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408 | 408 | | claims (and relevant data concerning each 1 |
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409 | 409 | | claim) for covered outpatient drugs that 2 |
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410 | 410 | | were purchased under an agreement under 3 |
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411 | 411 | | section 340B of the Public Health Service 4 |
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412 | 412 | | Act or other summary data specified by 5 |
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413 | 413 | | the manufacturer. 6 |
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414 | 414 | | ‘‘(iii) R |
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415 | 415 | | EPORT.—Each single State 7 |
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416 | 416 | | agency shall publish an annual report on 8 |
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417 | 417 | | utilization of covered outpatient drugs sub-9 |
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418 | 418 | | ject to an agreement under section 340B 10 |
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419 | 419 | | of the Public Health Service Act by the 11 |
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420 | 420 | | Medicaid fee-for-service program or a med-12 |
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421 | 421 | | icaid managed care organization (as de-13 |
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422 | 422 | | fined in section 1903(m)(1)(A)) during the 14 |
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423 | 423 | | preceding calendar year. The State agency 15 |
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424 | 424 | | shall not include confidential patient-spe-16 |
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425 | 425 | | cific, drug-specific, or manufacturer-spe-17 |
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426 | 426 | | cific information in any such annual re-18 |
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427 | 427 | | port.’’. 19 |
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428 | 428 | | (b) M |
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429 | 429 | | EDICARE.— 20 |
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430 | 430 | | (1) M |
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431 | 431 | | EDICARE PART B.— 21 |
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432 | 432 | | (A) H |
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433 | 433 | | OSPITAL OUTPATIENT DEPARTMENT 22 |
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434 | 434 | | SERVICES.—Section 1833(t) of the Social Secu-23 |
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435 | 435 | | rity Act (42 U.S.C. 1395l) is amended by add-24 |
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436 | 436 | | ing at the end the following paragraph: 25 |
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438 | 438 | | kjohnson on DSK79L0C42PROD with BILLS 16 |
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439 | 439 | | •HR 198 IH |
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440 | 440 | | ‘‘(22) 340B CLAIMS MODIFIER.—All claims sub-1 |
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441 | 441 | | mitted under the system under this subsection for 2 |
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442 | 442 | | reimbursement of a unit of a covered outpatient 3 |
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443 | 443 | | drug subject to an agreement under section 340B of 4 |
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444 | 444 | | the Public Health Service Act shall include the 340B 5 |
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445 | 445 | | modifier established by the Secretary under such 6 |
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446 | 446 | | system that is ‘JG’ (or ‘TB’ in the case of a claim 7 |
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447 | 447 | | for reimbursement under such system submitted by 8 |
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448 | 448 | | a hospital described in subparagraph (M) or (N) of 9 |
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449 | 449 | | section 340B(a)(4) of the Public Health Service Act 10 |
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450 | 450 | | or a rural sole community hospital described in sub-11 |
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451 | 451 | | paragraph (O) of such section).’’. 12 |
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452 | 452 | | (B) O |
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453 | 453 | | THER PART B CLAIMS .—Section 13 |
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454 | 454 | | 1847A of the Social Security Act (42 U.S.C. 14 |
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455 | 455 | | 1395w–3a) is amended by adding the following 15 |
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456 | 456 | | new subsection: 16 |
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457 | 457 | | ‘‘(k) 340B C |
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458 | 458 | | LAIMSMODIFIER.—All claims submitted 17 |
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459 | 459 | | under this part (other than under the prospective payment 18 |
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460 | 460 | | system for hospital outpatient department services under 19 |
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461 | 461 | | section 1833(t)) for reimbursement of a unit of a covered 20 |
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462 | 462 | | outpatient drug subject to an agreement under section 21 |
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463 | 463 | | 340B of the Public Health Service Act shall include the 22 |
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464 | 464 | | 340B modifier established by the Secretary under such 23 |
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465 | 465 | | payment system that is ‘JG’.’’. 24 |
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467 | 467 | | kjohnson on DSK79L0C42PROD with BILLS 17 |
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468 | 468 | | •HR 198 IH |
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469 | 469 | | (2) MEDICARE ADVANTAGE AND MEDICARE 1 |
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470 | 470 | | PART D.—Section 1857(e) of the Social Security Act 2 |
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471 | 471 | | (42 U.S.C. 1395w–27(e)) is amended by adding at 3 |
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472 | 472 | | the end the following new paragraph: 4 |
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473 | 473 | | ‘‘(6) 340B |
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474 | 474 | | CLAIMS MODIFIER.—All claims sub-5 |
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475 | 475 | | mitted to a Medicare Advantage organization or a 6 |
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476 | 476 | | PDP sponsor under this part and part D, respec-7 |
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477 | 477 | | tively, for reimbursement of a unit of a covered out-8 |
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478 | 478 | | patient drug subject to an agreement under section 9 |
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479 | 479 | | 340B of the Public Health Service Act shall include 10 |
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480 | 480 | | the 340B modifier established by the Secretary 11 |
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481 | 481 | | under the prospective payment system for hospital 12 |
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482 | 482 | | outpatient department services under section 13 |
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483 | 483 | | 1833(t) that is ‘JG’ or the Submission Clarification 14 |
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484 | 484 | | Code of ‘20’ developed by the National Council for 15 |
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485 | 485 | | Prescription Drug Programs (NCPDP).’’. 16 |
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486 | 486 | | (3) R |
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487 | 487 | | EPORT ON UTILIZATION UNDER MEDICARE 17 |
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488 | 488 | | PART B.—The Secretary of Health and Human 18 |
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489 | 489 | | Services shall publish an annual report on utilization 19 |
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490 | 490 | | under part B of title XVIII of the Social Security 20 |
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491 | 491 | | Act (42 U.S.C. 1395j et seq.) of covered outpatient 21 |
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492 | 492 | | drugs purchased subject to an agreement under sec-22 |
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493 | 493 | | tion 340B of the Public Health Service Act (42 23 |
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494 | 494 | | U.S.C. 256b) during the preceding calendar year. 24 |
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495 | 495 | | The Secretary shall not include confidential patient- 25 |
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497 | 497 | | kjohnson on DSK79L0C42PROD with BILLS 18 |
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498 | 498 | | •HR 198 IH |
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499 | 499 | | specific, drug-specific, or manufacturer-specific in-1 |
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500 | 500 | | formation in any such annual report. 2 |
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501 | 501 | | (c) E |
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502 | 502 | | FFECTIVEDATE.—The amendments made by 3 |
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503 | 503 | | this section take effect on the date that is 6 months after 4 |
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504 | 504 | | the date of enactment of this Act and apply to claims sub-5 |
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505 | 505 | | mitted on or after that date. 6 |
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506 | 506 | | SEC. 4. REPORTS TO CONGRESS. 7 |
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507 | 507 | | Section 340B of the Public Health Service Act (42 8 |
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508 | 508 | | U.S.C. 256b) is amended by adding at the end the fol-9 |
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509 | 509 | | lowing: 10 |
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510 | 510 | | ‘‘(f) R |
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511 | 511 | | EPORTS TOCONGRESS.— 11 |
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512 | 512 | | ‘‘(1) OIG |
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513 | 513 | | REPORT.—Not later than 2 years 12 |
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514 | 514 | | after the date of the enactment of this subsection, 13 |
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515 | 515 | | the Office of the Inspector General shall submit to 14 |
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516 | 516 | | Congress a final report on the level of charity care 15 |
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517 | 517 | | provided by covered entities described in subpara-16 |
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518 | 518 | | graph (L) of subsection (a)(4) and separately by 17 |
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519 | 519 | | child sites of such covered entities. 18 |
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520 | 520 | | ‘‘(2) GAO |
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521 | 521 | | REPORTS.— 19 |
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522 | 522 | | ‘‘(A) I |
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523 | 523 | | NITIAL REPORT.—Not later than 1 20 |
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524 | 524 | | year after the date of the enactment of this 21 |
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525 | 525 | | subsection, the Comptroller General of the 22 |
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526 | 526 | | United States shall submit to Congress a re-23 |
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527 | 527 | | port— 24 |
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529 | 529 | | kjohnson on DSK79L0C42PROD with BILLS 19 |
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530 | 530 | | •HR 198 IH |
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531 | 531 | | ‘‘(i) analyzing the State and local gov-1 |
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532 | 532 | | ernment contracts intended to satisfy the 2 |
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533 | 533 | | requirement under subsection (a)(4)(L)(i) 3 |
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534 | 534 | | for a covered entity to qualify as an entity 4 |
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535 | 535 | | described in subparagraph (L) of sub-5 |
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536 | 536 | | section (a)(4); 6 |
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537 | 537 | | ‘‘(ii) assessing the amount of care 7 |
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538 | 538 | | such contracts obligate such entity to pro-8 |
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539 | 539 | | vide to low-income individuals ineligible for 9 |
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540 | 540 | | Medicare under title XVIII of the Social 10 |
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541 | 541 | | Security Act and Medicaid under title XIX 11 |
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542 | 542 | | of such Act; and 12 |
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543 | 543 | | ‘‘(iii) analyzing how these contracts 13 |
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544 | 544 | | define low-income individuals and whether 14 |
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545 | 545 | | the Secretary reviews such determinations. 15 |
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546 | 546 | | ‘‘(B) S |
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547 | 547 | | UBSEQUENT REPORT .—Not later 16 |
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548 | 548 | | than 2 years after the date of the enactment of 17 |
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549 | 549 | | this subsection, the Comptroller General of the 18 |
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550 | 550 | | United States shall submit to Congress a final 19 |
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551 | 551 | | report on the difference between the aggregate 20 |
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552 | 552 | | gross reimbursement and aggregate acquisition 21 |
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553 | 553 | | costs received by each such covered entity (in-22 |
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554 | 554 | | cluding child sites of such entity) for drugs sub-23 |
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555 | 555 | | ject to an agreement under this section.’’. 24 |
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557 | 557 | | kjohnson on DSK79L0C42PROD with BILLS 20 |
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558 | 558 | | •HR 198 IH |
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559 | 559 | | SEC. 5. MEDICARE REQUIREMENT FOR HOSPITALS RE-1 |
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560 | 560 | | GARDING 340B DRUG INFORMATION. 2 |
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561 | 561 | | (a) I |
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562 | 562 | | NGENERAL.—Section 1866(a)(1) of the Social 3 |
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563 | 563 | | Security Act (42 U.S.C. 1395cc(a)(1)) is amended— 4 |
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564 | 564 | | (1) in subparagraph (X), by striking ‘‘and’’ at 5 |
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565 | 565 | | the end; 6 |
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566 | 566 | | (2) in subparagraph (Y), by striking the period 7 |
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567 | 567 | | at the end and inserting ‘‘, and’’; and 8 |
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568 | 568 | | (3) by inserting after subparagraph (Y), the fol-9 |
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569 | 569 | | lowing new subparagraph: 10 |
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570 | 570 | | ‘‘(Z) in the case of a hospital that is a covered 11 |
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571 | 571 | | entity under subsection (a)(4) of section 340B of the 12 |
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572 | 572 | | Public Health Service Act, to include in any cost re-13 |
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573 | 573 | | port submitted to the Secretary under this title in-14 |
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574 | 574 | | formation on— 15 |
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575 | 575 | | ‘‘(i) the aggregate acquisition costs of the 16 |
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576 | 576 | | hospital for drugs, the purchase of which were 17 |
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577 | 577 | | attributed to the hospital, during the period 18 |
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578 | 578 | | covered by such cost report and for which the 19 |
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579 | 579 | | hospital received a discount under such section 20 |
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580 | 580 | | 340B; and 21 |
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581 | 581 | | ‘‘(ii) the aggregate revenues the hospital 22 |
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582 | 582 | | received from all payors for such drugs, 23 |
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583 | 583 | | disaggregated by insurance status (including 24 |
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584 | 584 | | the Medicare program, the Medicaid program, 25 |
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586 | 586 | | kjohnson on DSK79L0C42PROD with BILLS 21 |
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587 | 587 | | •HR 198 IH |
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588 | 588 | | the Children’s Health Insurance Program, pri-1 |
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589 | 589 | | vate health insurance, and uninsured).’’. 2 |
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590 | 590 | | (b) E |
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591 | 591 | | FFECTIVEDATE.—The amendments made by 3 |
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592 | 592 | | subsection (a) shall apply to contracts entered into or re-4 |
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593 | 593 | | newed on or after the date of the enactment of this Act. 5 |
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594 | 594 | | Æ |
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