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. 927 |
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5 | 5 | | To amend title XIX of the Social Security Act to ensure accurate payments |
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6 | 6 | | to pharmacies under Medicaid and to prevent the use of abusive spread |
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7 | 7 | | pricing practices under Medicaid. |
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8 | 8 | | IN THE SENATE OF THE UNITED STATES |
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9 | 9 | | MARCH11 (legislative day, MARCH10), 2025 |
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10 | 10 | | Mr. W |
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11 | 11 | | ELCH(for himself, Mr. MARSHALL, Mr. WARNER, and Mr. CASSIDY) |
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12 | 12 | | introduced the following bill; which was read twice and referred to the |
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13 | 13 | | Committee on Finance |
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14 | 14 | | A BILL |
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15 | 15 | | To amend title XIX of the Social Security Act to ensure |
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16 | 16 | | accurate payments to pharmacies under Medicaid and |
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17 | 17 | | to prevent the use of abusive spread pricing practices |
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18 | 18 | | under Medicaid. |
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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 ‘‘Protecting Pharmacies 4 |
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23 | 23 | | in Medicaid Act’’. 5 |
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25 | 25 | | ssavage on LAPJG3WLY3PROD with BILLS 2 |
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26 | 26 | | •S 927 IS |
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27 | 27 | | SEC. 2. ENSURING ACCURATE PAYMENTS TO PHARMACIES 1 |
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28 | 28 | | UNDER MEDICAID. 2 |
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29 | 29 | | (a) I |
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30 | 30 | | NGENERAL.—Section 1927(f) of the Social Se-3 |
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31 | 31 | | curity Act (42 U.S.C. 1396r–8(f)) is amended— 4 |
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32 | 32 | | (1) in paragraph (1)(A)— 5 |
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33 | 33 | | (A) by redesignating clause (ii) as clause 6 |
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34 | 34 | | (iii); and 7 |
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35 | 35 | | (B) by striking ‘‘and’’ after the semicolon 8 |
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36 | 36 | | at the end of clause (i) and all that precedes it 9 |
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37 | 37 | | through ‘‘(1)’’ and inserting the following: 10 |
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38 | 38 | | ‘‘(1) D |
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39 | 39 | | ETERMINING PHARMACY ACTUAL ACQUI -11 |
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40 | 40 | | SITION COSTS.—The Secretary shall conduct a sur-12 |
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41 | 41 | | vey of retail community pharmacy drug prices and 13 |
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42 | 42 | | applicable non-retail pharmacy drug prices to deter-14 |
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43 | 43 | | mine national average drug acquisition cost bench-15 |
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44 | 44 | | marks (as such term is defined by the Secretary) as 16 |
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45 | 45 | | follows: 17 |
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46 | 46 | | ‘‘(A) U |
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47 | 47 | | SE OF VENDOR .—The Secretary 18 |
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48 | 48 | | may contract services for— 19 |
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49 | 49 | | ‘‘(i) with respect to retail community 20 |
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50 | 50 | | pharmacies, the determination of retail 21 |
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51 | 51 | | survey prices of the national average drug 22 |
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52 | 52 | | acquisition cost for covered outpatient 23 |
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53 | 53 | | drugs that represent a nationwide average 24 |
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54 | 54 | | of consumer purchase prices for such 25 |
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55 | 55 | | drugs, net of all discounts, rebates, and 26 |
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57 | 57 | | ssavage on LAPJG3WLY3PROD with BILLS 3 |
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58 | 58 | | •S 927 IS |
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59 | 59 | | other price concessions (to the extent any 1 |
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60 | 60 | | information with respect to such discounts, 2 |
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61 | 61 | | rebates, and other price concessions is 3 |
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62 | 62 | | available) based on a monthly survey of 4 |
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63 | 63 | | such pharmacies; and 5 |
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64 | 64 | | ‘‘(ii) with respect to applicable non-re-6 |
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65 | 65 | | tail pharmacies— 7 |
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66 | 66 | | ‘‘(I) the determination of survey 8 |
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67 | 67 | | prices, separate from the survey prices 9 |
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68 | 68 | | described in clause (i), of the non-re-10 |
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69 | 69 | | tail national average drug acquisition 11 |
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70 | 70 | | cost for covered outpatient drugs that 12 |
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71 | 71 | | represent a nationwide average of con-13 |
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72 | 72 | | sumer purchase prices for such drugs, 14 |
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73 | 73 | | net of all discounts, rebates, and other 15 |
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74 | 74 | | price concessions (to the extent any 16 |
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75 | 75 | | information with respect to such dis-17 |
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76 | 76 | | counts, rebates, and other price con-18 |
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77 | 77 | | cessions is available) based on a 19 |
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78 | 78 | | monthly survey of such pharmacies; 20 |
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79 | 79 | | and 21 |
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80 | 80 | | ‘‘(II) at the discretion of the Sec-22 |
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81 | 81 | | retary, for each type of applicable 23 |
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82 | 82 | | non-retail pharmacy, the determina-24 |
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83 | 83 | | tion of survey prices, separate from 25 |
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86 | 86 | | •S 927 IS |
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87 | 87 | | the survey prices described in clause 1 |
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88 | 88 | | (i) or subclause (I) of this clause, of 2 |
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89 | 89 | | the national average drug acquisition 3 |
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90 | 90 | | cost for such type of pharmacy for 4 |
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91 | 91 | | covered outpatient drugs that rep-5 |
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92 | 92 | | resent a nationwide average of con-6 |
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93 | 93 | | sumer purchase prices for such drugs, 7 |
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94 | 94 | | net of all discounts, rebates, and other 8 |
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95 | 95 | | price concessions (to the extent any 9 |
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96 | 96 | | information with respect to such dis-10 |
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97 | 97 | | counts, rebates, and other price con-11 |
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98 | 98 | | cessions is available) based on a 12 |
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99 | 99 | | monthly survey of such pharmacies; 13 |
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100 | 100 | | and’’; 14 |
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101 | 101 | | (2) in subparagraph (B) of paragraph (1), by 15 |
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102 | 102 | | striking ‘‘subparagraph (A)(ii)’’ and inserting ‘‘sub-16 |
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103 | 103 | | paragraph (A)(iii)’’; 17 |
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104 | 104 | | (3) in subparagraph (D) of paragraph (1), by 18 |
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105 | 105 | | striking clauses (ii) and (iii) and inserting the fol-19 |
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106 | 106 | | lowing: 20 |
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107 | 107 | | ‘‘(ii) The vendor must update the Sec-21 |
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108 | 108 | | retary no less often than monthly on the 22 |
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109 | 109 | | survey prices for covered outpatient drugs. 23 |
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110 | 110 | | ‘‘(iii) The vendor must differentiate, 24 |
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111 | 111 | | in collecting and reporting survey data, for 25 |
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113 | 113 | | ssavage on LAPJG3WLY3PROD with BILLS 5 |
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114 | 114 | | •S 927 IS |
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115 | 115 | | all cost information collected, whether a 1 |
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116 | 116 | | pharmacy is a retail community pharmacy 2 |
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117 | 117 | | or an applicable non-retail pharmacy, in-3 |
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118 | 118 | | cluding whether such pharmacy is an affil-4 |
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119 | 119 | | iate (as defined in subsection (k)(14)), 5 |
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120 | 120 | | and, in the case of an applicable non-retail 6 |
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121 | 121 | | pharmacy, which type of applicable non-re-7 |
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122 | 122 | | tail pharmacy it is using the relevant phar-8 |
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123 | 123 | | macy type indicators included in the guid-9 |
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124 | 124 | | ance required by subsection (d)(2) of sec-10 |
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125 | 125 | | tion 2 of the Protecting Pharmacies in 11 |
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126 | 126 | | Medicaid Act.’’; 12 |
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127 | 127 | | (4) by adding at the end of paragraph (1) the 13 |
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128 | 128 | | following: 14 |
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129 | 129 | | ‘‘(F) S |
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130 | 130 | | URVEY REPORTING .—In order to 15 |
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131 | 131 | | meet the requirement of section 1902(a)(54), a 16 |
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132 | 132 | | State shall require that any retail community 17 |
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133 | 133 | | pharmacy or applicable non-retail pharmacy in 18 |
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134 | 134 | | the State that receives any payment, reimburse-19 |
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135 | 135 | | ment, administrative fee, discount, rebate, or 20 |
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136 | 136 | | other price concession related to the dispensing 21 |
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137 | 137 | | of covered outpatient drugs to individuals re-22 |
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138 | 138 | | ceiving benefits under this title, regardless of 23 |
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139 | 139 | | whether such payment, reimbursement, admin-24 |
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140 | 140 | | istrative fee, discount, rebate, or other price 25 |
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143 | 143 | | •S 927 IS |
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144 | 144 | | concession is received from the State or a man-1 |
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145 | 145 | | aged care entity or other specified entity (as 2 |
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146 | 146 | | such terms are defined in section 3 |
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147 | 147 | | 1903(m)(9)(D)) directly or from a pharmacy 4 |
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148 | 148 | | benefit manager or another entity that has a 5 |
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149 | 149 | | contract with the State or a managed care enti-6 |
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150 | 150 | | ty or other specified entity (as so defined), shall 7 |
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151 | 151 | | respond to surveys conducted under this para-8 |
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152 | 152 | | graph. 9 |
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153 | 153 | | ‘‘(G) S |
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154 | 154 | | URVEY INFORMATION .—Information 10 |
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155 | 155 | | on national drug acquisition prices obtained 11 |
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156 | 156 | | under this paragraph shall be made publicly 12 |
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157 | 157 | | available in a form and manner to be deter-13 |
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158 | 158 | | mined by the Secretary and shall include at 14 |
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159 | 159 | | least the following: 15 |
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160 | 160 | | ‘‘(i) The monthly response rate to the 16 |
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161 | 161 | | survey including a list of pharmacies not in 17 |
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162 | 162 | | compliance with subparagraph (F). 18 |
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163 | 163 | | ‘‘(ii) The sampling methodology and 19 |
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164 | 164 | | number of pharmacies sampled monthly. 20 |
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165 | 165 | | ‘‘(iii) Information on price concessions 21 |
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166 | 166 | | to pharmacies, including discounts, re-22 |
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167 | 167 | | bates, and other price concessions, to the 23 |
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168 | 168 | | extent that such information may be pub-24 |
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170 | 170 | | ssavage on LAPJG3WLY3PROD with BILLS 7 |
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171 | 171 | | •S 927 IS |
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172 | 172 | | licly released and has been collected by the 1 |
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173 | 173 | | Secretary as part of the survey. 2 |
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174 | 174 | | ‘‘(H) P |
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175 | 175 | | ENALTIES.— 3 |
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176 | 176 | | ‘‘(i) I |
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177 | 177 | | N GENERAL.—Subject to clauses 4 |
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178 | 178 | | (ii), (iii), and (iv), the Secretary shall en-5 |
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179 | 179 | | force the provisions of this paragraph with 6 |
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180 | 180 | | respect to a pharmacy through the estab-7 |
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181 | 181 | | lishment of civil money penalties applicable 8 |
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182 | 182 | | to a retail community pharmacy or an ap-9 |
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183 | 183 | | plicable non-retail pharmacy. 10 |
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184 | 184 | | ‘‘(ii) B |
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185 | 185 | | ASIS FOR PENALTIES .—The 11 |
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186 | 186 | | Secretary shall impose a civil money pen-12 |
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187 | 187 | | alty established under this subparagraph 13 |
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188 | 188 | | on a retail community pharmacy or appli-14 |
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189 | 189 | | cable non-retail pharmacy if— 15 |
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190 | 190 | | ‘‘(I) the retail pharmacy or appli-16 |
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191 | 191 | | cable non-retail pharmacy refuses or 17 |
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192 | 192 | | otherwise fails to respond to a request 18 |
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193 | 193 | | for information about prices in con-19 |
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194 | 194 | | nection with a survey under this sub-20 |
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195 | 195 | | section; 21 |
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196 | 196 | | ‘‘(II) knowingly provides false in-22 |
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197 | 197 | | formation in response to such a sur-23 |
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198 | 198 | | vey; or 24 |
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201 | 201 | | •S 927 IS |
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202 | 202 | | ‘‘(III) otherwise fails to comply 1 |
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203 | 203 | | with the requirements established 2 |
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204 | 204 | | under this paragraph. 3 |
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205 | 205 | | ‘‘(iii) P |
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206 | 206 | | ARAMETERS FOR PEN -4 |
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207 | 207 | | ALTIES.— 5 |
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208 | 208 | | ‘‘(I) I |
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209 | 209 | | N GENERAL.—A civil money 6 |
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210 | 210 | | penalty established under this sub-7 |
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211 | 211 | | paragraph may be assessed with re-8 |
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212 | 212 | | spect to each violation, and with re-9 |
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213 | 213 | | spect to each non-compliant retail 10 |
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214 | 214 | | community pharmacy (including a 11 |
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215 | 215 | | pharmacy that is part of a chain) or 12 |
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216 | 216 | | non-compliant applicable non-retail 13 |
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217 | 217 | | pharmacy (including a pharmacy that 14 |
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218 | 218 | | is part of a chain), in an amount not 15 |
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219 | 219 | | to exceed $100,000 for each such vio-16 |
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220 | 220 | | lation. 17 |
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221 | 221 | | ‘‘(II) C |
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222 | 222 | | ONSIDERATIONS.—In de-18 |
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223 | 223 | | termining the amount of a civil money 19 |
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224 | 224 | | penalty imposed under this subpara-20 |
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225 | 225 | | graph, the Secretary may consider the 21 |
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226 | 226 | | size, business structure, and type of 22 |
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227 | 227 | | pharmacy involved, as well as the type 23 |
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228 | 228 | | of violation and other relevant factors, 24 |
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231 | 231 | | •S 927 IS |
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232 | 232 | | as determined appropriate by the Sec-1 |
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233 | 233 | | retary. 2 |
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234 | 234 | | ‘‘(iv) R |
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235 | 235 | | ULE OF APPLICATION .—The 3 |
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236 | 236 | | provisions of section 1128A (other than 4 |
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237 | 237 | | subsections (a) and (b)) shall apply to a 5 |
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238 | 238 | | civil money penalty under this subpara-6 |
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239 | 239 | | graph in the same manner as such provi-7 |
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240 | 240 | | sions apply to a civil money penalty or pro-8 |
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241 | 241 | | ceeding under section 1128A(a). 9 |
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242 | 242 | | ‘‘(I) L |
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243 | 243 | | IMITATION ON USE OF APPLICABLE 10 |
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244 | 244 | | NON-RETAIL PHARMACY PRICING INFORMA -11 |
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245 | 245 | | TION.—No State shall use pricing information 12 |
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246 | 246 | | reported by applicable non-retail pharmacies 13 |
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247 | 247 | | under subparagraph (A)(ii) to develop or inform 14 |
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248 | 248 | | payment methodologies for retail community 15 |
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249 | 249 | | pharmacies.’’; 16 |
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250 | 250 | | (5) in paragraph (2)— 17 |
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251 | 251 | | (A) in subparagraph (A), by inserting ‘‘, 18 |
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252 | 252 | | including payment rates and methodologies for 19 |
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253 | 253 | | determining ingredient cost reimbursement 20 |
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254 | 254 | | under managed care entities or other specified 21 |
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255 | 255 | | entities (as such terms are defined in section 22 |
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256 | 256 | | 1903(m)(9)(D)),’’ after ‘‘under this title’’; and 23 |
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259 | 259 | | •S 927 IS |
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260 | 260 | | (B) in subparagraph (B), by inserting 1 |
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261 | 261 | | ‘‘and the basis for such dispensing fees’’ before 2 |
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262 | 262 | | the semicolon; 3 |
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263 | 263 | | (6) by redesignating paragraph (4) as para-4 |
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264 | 264 | | graph (5); 5 |
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265 | 265 | | (7) by inserting after paragraph (3) the fol-6 |
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266 | 266 | | lowing new paragraph: 7 |
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267 | 267 | | ‘‘(4) O |
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268 | 268 | | VERSIGHT.— 8 |
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269 | 269 | | ‘‘(A) I |
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270 | 270 | | N GENERAL.—The Inspector General 9 |
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271 | 271 | | of the Department of Health and Human Serv-10 |
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272 | 272 | | ices shall conduct periodic studies of the survey 11 |
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273 | 273 | | data reported under this subsection, as appro-12 |
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274 | 274 | | priate, including with respect to substantial 13 |
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275 | 275 | | variations in acquisition costs or other applica-14 |
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276 | 276 | | ble costs, as well as with respect to how internal 15 |
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277 | 277 | | transfer prices and related party transactions 16 |
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278 | 278 | | may influence the costs reported by pharmacies 17 |
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279 | 279 | | that are affiliates (as defined in subsection 18 |
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280 | 280 | | (k)(14)) or are owned by, controlled by, or re-19 |
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281 | 281 | | lated under a common ownership structure with 20 |
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282 | 282 | | a wholesaler, distributor, or other entity that 21 |
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283 | 283 | | acquires covered outpatient drugs relative to 22 |
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284 | 284 | | costs reported by pharmacies not affiliated with 23 |
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285 | 285 | | such entities. The Inspector General shall pro-24 |
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286 | 286 | | vide periodic updates to Congress on the results 25 |
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289 | 289 | | •S 927 IS |
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290 | 290 | | of such studies, as appropriate, in a manner 1 |
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291 | 291 | | that does not disclose trade secrets or other 2 |
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292 | 292 | | proprietary information. 3 |
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293 | 293 | | ‘‘(B) A |
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294 | 294 | | PPROPRIATION.—There is appro-4 |
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295 | 295 | | priated to the Inspector General of the Depart-5 |
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296 | 296 | | ment of Health and Human Services, out of 6 |
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297 | 297 | | any money in the Treasury not otherwise ap-7 |
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298 | 298 | | propriated, $5,000,000 for fiscal year 2026, to 8 |
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299 | 299 | | remain available until expended, to carry out 9 |
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300 | 300 | | this paragraph.’’; and 10 |
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301 | 301 | | (8) in paragraph (5), as so redesignated— 11 |
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302 | 302 | | (A) by inserting ‘‘, and $9,000,000 for fis-12 |
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303 | 303 | | cal year 2026 and each fiscal year thereafter,’’ 13 |
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304 | 304 | | after ‘‘2010’’; and 14 |
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305 | 305 | | (B) by inserting ‘‘Funds appropriated 15 |
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306 | 306 | | under this paragraph for fiscal year 2026 and 16 |
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307 | 307 | | any subsequent fiscal year shall remain avail-17 |
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308 | 308 | | able until expended.’’ after the period. 18 |
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309 | 309 | | (b) D |
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310 | 310 | | EFINITIONS.—Section 1927(k) of the Social Se-19 |
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311 | 311 | | curity Act (42 U.S.C. 1396r–8(k)) is amended— 20 |
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312 | 312 | | (1) in the matter preceding paragraph (1), by 21 |
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313 | 313 | | striking ‘‘In the section’’ and inserting ‘‘In this sec-22 |
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314 | 314 | | tion’’; and 23 |
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315 | 315 | | (2) by adding at the end the following new 24 |
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316 | 316 | | paragraphs: 25 |
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319 | 319 | | •S 927 IS |
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320 | 320 | | ‘‘(12) APPLICABLE NON-RETAIL PHARMACY .— 1 |
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321 | 321 | | The term ‘applicable non-retail pharmacy’ means a 2 |
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322 | 322 | | pharmacy that is licensed as a pharmacy by the 3 |
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323 | 323 | | State and that is not a retail community pharmacy, 4 |
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324 | 324 | | including a pharmacy that dispenses prescription 5 |
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325 | 325 | | medications to patients primarily through mail and 6 |
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326 | 326 | | specialty pharmacies. Such term does not include 7 |
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327 | 327 | | nursing home pharmacies, long-term care facility 8 |
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328 | 328 | | pharmacies, hospital pharmacies, clinics, charitable 9 |
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329 | 329 | | or not-for-profit pharmacies, government phar-10 |
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330 | 330 | | macies, or low dispensing pharmacies (as defined by 11 |
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331 | 331 | | the Secretary). 12 |
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332 | 332 | | ‘‘(13) A |
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333 | 333 | | FFILIATE.—The term ‘affiliate’ means 13 |
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334 | 334 | | any entity that is owned by, controlled by, or related 14 |
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335 | 335 | | under a common ownership structure with a phar-15 |
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336 | 336 | | macy benefit manager or a managed care entity or 16 |
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337 | 337 | | other specified entity (as such terms are defined in 17 |
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338 | 338 | | section 1903(m)(9)(D)).’’. 18 |
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339 | 339 | | (c) E |
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340 | 340 | | FFECTIVEDATE.— 19 |
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341 | 341 | | (1) I |
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342 | 342 | | N GENERAL.—Subject to paragraph (2), 20 |
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343 | 343 | | the amendments made by this section shall take ef-21 |
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344 | 344 | | fect on the first day of the first quarter that begins 22 |
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345 | 345 | | on or after the date that is 6 months after the date 23 |
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346 | 346 | | of enactment of this Act. 24 |
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348 | 348 | | ssavage on LAPJG3WLY3PROD with BILLS 13 |
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349 | 349 | | •S 927 IS |
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350 | 350 | | (2) DELAYED APPLICATION TO APPLICABLE 1 |
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351 | 351 | | NON-RETAIL PHARMACIES .—The pharmacy survey 2 |
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352 | 352 | | requirements established by the amendments to sec-3 |
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353 | 353 | | tion 1927(f) of the Social Security Act (42 U.S.C. 4 |
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354 | 354 | | 1396r–8(f)) made by this section shall apply to re-5 |
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355 | 355 | | tail community pharmacies beginning on the effec-6 |
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356 | 356 | | tive date described in paragraph (1), but shall not 7 |
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357 | 357 | | apply to applicable non-retail pharmacies until the 8 |
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358 | 358 | | first day of the first quarter that begins on or after 9 |
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359 | 359 | | the date that is 18 months after the date of enact-10 |
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360 | 360 | | ment of this Act. 11 |
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361 | 361 | | (d) I |
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362 | 362 | | DENTIFICATION OF APPLICABLENON-RETAIL 12 |
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363 | 363 | | P |
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364 | 364 | | HARMACIES.— 13 |
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365 | 365 | | (1) I |
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366 | 366 | | N GENERAL.—Not later than January 1, 14 |
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367 | 367 | | 2027, the Secretary of Health and Human Services 15 |
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368 | 368 | | shall, in consultation with stakeholders as appro-16 |
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369 | 369 | | priate, publish guidance specifying pharmacies that 17 |
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370 | 370 | | meet the definition of applicable non-retail phar-18 |
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371 | 371 | | macies (as such term is defined in subsection 19 |
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372 | 372 | | (k)(12) of section 1927 of the Social Security Act 20 |
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373 | 373 | | (42 U.S.C. 1396r–8), as added by subsection (b)), 21 |
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374 | 374 | | and that will be subject to the survey requirements 22 |
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375 | 375 | | under subsection (f)(1) of such section, as amended 23 |
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376 | 376 | | by subsection (a). 24 |
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378 | 378 | | ssavage on LAPJG3WLY3PROD with BILLS 14 |
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379 | 379 | | •S 927 IS |
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380 | 380 | | (2) INCLUSION OF PHARMACY TYPE INDICA -1 |
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381 | 381 | | TORS.—The guidance published under paragraph (1) 2 |
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382 | 382 | | shall include pharmacy type indicators to distinguish 3 |
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383 | 383 | | between different types of applicable non-retail phar-4 |
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384 | 384 | | macies, such as pharmacies that dispense prescrip-5 |
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385 | 385 | | tions primarily through the mail and pharmacies 6 |
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386 | 386 | | that dispense prescriptions that require special han-7 |
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387 | 387 | | dling or distribution. An applicable non-retail phar-8 |
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388 | 388 | | macy may be identified through multiple pharmacy 9 |
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389 | 389 | | type indicators. 10 |
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390 | 390 | | (e) I |
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391 | 391 | | MPLEMENTATION.— 11 |
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392 | 392 | | (1) I |
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393 | 393 | | N GENERAL.—Notwithstanding any other 12 |
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394 | 394 | | provision of law, the Secretary of Health and 13 |
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395 | 395 | | Human Services may implement the amendments 14 |
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396 | 396 | | made by this section by program instruction or oth-15 |
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397 | 397 | | erwise. 16 |
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398 | 398 | | (2) N |
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399 | 399 | | ONAPPLICATION OF ADMINISTRATIVE PRO -17 |
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400 | 400 | | CEDURE ACT.—Implementation of the amendments 18 |
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401 | 401 | | made by this section shall be exempt from the re-19 |
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402 | 402 | | quirements of section 553 of title 5, United States 20 |
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403 | 403 | | Code. 21 |
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404 | 404 | | (f) N |
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405 | 405 | | ONAPPLICATION OF PAPERWORKREDUCTION 22 |
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406 | 406 | | A |
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407 | 407 | | CT.—Chapter 35 of title 44, United States Code, shall 23 |
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408 | 408 | | not apply to any data collection undertaken by the Sec-24 |
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409 | 409 | | retary of Health and Human Services under section 25 |
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411 | 411 | | ssavage on LAPJG3WLY3PROD with BILLS 15 |
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412 | 412 | | •S 927 IS |
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413 | 413 | | 1927(f) of the Social Security Act (42 U.S.C. 1396r–8(f)), 1 |
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414 | 414 | | as amended by this section. 2 |
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415 | 415 | | SEC. 3. PREVENTING THE USE OF ABUSIVE SPREAD PRIC-3 |
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416 | 416 | | ING IN MEDICAID. 4 |
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417 | 417 | | (a) I |
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418 | 418 | | NGENERAL.—Section 1927 of the Social Secu-5 |
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419 | 419 | | rity Act (42 U.S.C. 1396r–8) is amended— 6 |
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420 | 420 | | (1) in subsection (e), by adding at the end the 7 |
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421 | 421 | | following new paragraph: 8 |
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422 | 422 | | ‘‘(6) T |
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423 | 423 | | RANSPARENT PRESCRIPTION DRUG PASS - 9 |
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424 | 424 | | THROUGH PRICING REQUIRED .— 10 |
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425 | 425 | | ‘‘(A) I |
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426 | 426 | | N GENERAL.—A contract between 11 |
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427 | 427 | | the State and a pharmacy benefit manager (re-12 |
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428 | 428 | | ferred to in this paragraph as a ‘PBM’), or a 13 |
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429 | 429 | | contract between the State and a managed care 14 |
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430 | 430 | | entity or other specified entity (as such terms 15 |
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431 | 431 | | are defined in section 1903(m)(9)(D) and col-16 |
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432 | 432 | | lectively referred to in this paragraph as the 17 |
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433 | 433 | | ‘entity’) that includes provisions making the en-18 |
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434 | 434 | | tity responsible for coverage of covered out-19 |
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435 | 435 | | patient drugs dispensed to individuals enrolled 20 |
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436 | 436 | | with the entity, shall require that payment for 21 |
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437 | 437 | | such drugs and related administrative services 22 |
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438 | 438 | | (as applicable), including payments made by a 23 |
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439 | 439 | | PBM on behalf of the State or entity, is based 24 |
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440 | 440 | | VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 |
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441 | 441 | | ssavage on LAPJG3WLY3PROD with BILLS 16 |
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442 | 442 | | •S 927 IS |
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443 | 443 | | on a transparent prescription drug pass- 1 |
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444 | 444 | | through pricing model under which— 2 |
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445 | 445 | | ‘‘(i) any payment made by the entity 3 |
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446 | 446 | | or the PBM (as applicable) for such a 4 |
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447 | 447 | | drug— 5 |
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448 | 448 | | ‘‘(I) is limited to— 6 |
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449 | 449 | | ‘‘(aa) ingredient cost; and 7 |
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450 | 450 | | ‘‘(bb) a professional dis-8 |
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451 | 451 | | pensing fee that is not less than 9 |
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452 | 452 | | the professional dispensing fee 10 |
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453 | 453 | | that the State would pay if the 11 |
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454 | 454 | | State were making the payment 12 |
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455 | 455 | | directly in accordance with the 13 |
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456 | 456 | | State plan; 14 |
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457 | 457 | | ‘‘(II) is passed through in its en-15 |
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458 | 458 | | tirety (except as reduced under Fed-16 |
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459 | 459 | | eral or State laws and regulations in 17 |
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460 | 460 | | response to instances of waste, fraud, 18 |
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461 | 461 | | or abuse) by the entity or PBM to the 19 |
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462 | 462 | | pharmacy or provider that dispenses 20 |
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463 | 463 | | the drug; and 21 |
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464 | 464 | | ‘‘(III) is made in a manner that 22 |
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465 | 465 | | is consistent with sections 447.502, 23 |
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466 | 466 | | 447.512, 447.514, and 447.518 of 24 |
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467 | 467 | | title 42, Code of Federal Regulations 25 |
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469 | 469 | | ssavage on LAPJG3WLY3PROD with BILLS 17 |
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470 | 470 | | •S 927 IS |
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471 | 471 | | (or any successor regulation) as if 1 |
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472 | 472 | | such requirements applied directly to 2 |
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473 | 473 | | the entity or the PBM, except that 3 |
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474 | 474 | | any payment by the entity or the 4 |
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475 | 475 | | PBM for the ingredient cost of such 5 |
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476 | 476 | | drug purchased by a covered entity 6 |
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477 | 477 | | (as defined in subsection (a)(5)(B)) 7 |
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478 | 478 | | may exceed the actual acquisition cost 8 |
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479 | 479 | | (as defined in 447.502 of title 42, 9 |
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480 | 480 | | Code of Federal Regulations, or any 10 |
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481 | 481 | | successor regulation) for such drug 11 |
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482 | 482 | | if— 12 |
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483 | 483 | | ‘‘(aa) such drug was subject 13 |
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484 | 484 | | to an agreement under section 14 |
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485 | 485 | | 340B of the Public Health Serv-15 |
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486 | 486 | | ice Act; 16 |
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487 | 487 | | ‘‘(bb) such payment for the 17 |
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488 | 488 | | ingredient cost of such drug does 18 |
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489 | 489 | | not exceed the maximum pay-19 |
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490 | 490 | | ment that would have been made 20 |
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491 | 491 | | by the entity or the PBM for the 21 |
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492 | 492 | | ingredient cost of such drug if 22 |
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493 | 493 | | such drug had not been pur-23 |
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494 | 494 | | chased by such covered entity; 24 |
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495 | 495 | | and 25 |
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497 | 497 | | ssavage on LAPJG3WLY3PROD with BILLS 18 |
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498 | 498 | | •S 927 IS |
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499 | 499 | | ‘‘(cc) such covered entity re-1 |
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500 | 500 | | ports to the Secretary (in a form 2 |
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501 | 501 | | and manner specified by the Sec-3 |
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502 | 502 | | retary), on an annual basis and 4 |
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503 | 503 | | with respect to payments for the 5 |
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504 | 504 | | ingredient costs of such drugs so 6 |
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505 | 505 | | purchased by such covered entity 7 |
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506 | 506 | | that are in excess of the actual 8 |
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507 | 507 | | acquisition costs for such drugs, 9 |
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508 | 508 | | the aggregate amount of such ex-10 |
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509 | 509 | | cess; 11 |
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510 | 510 | | ‘‘(ii) payment to the entity or the 12 |
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511 | 511 | | PBM (as applicable) for administrative 13 |
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512 | 512 | | services performed by the entity or PBM is 14 |
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513 | 513 | | limited to an administrative fee that re-15 |
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514 | 514 | | flects the fair market value (as defined by 16 |
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515 | 515 | | the Secretary) of such services; 17 |
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516 | 516 | | ‘‘(iii) the entity or the PBM (as appli-18 |
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517 | 517 | | cable) makes available to the State, and 19 |
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518 | 518 | | the Secretary upon request in a form and 20 |
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519 | 519 | | manner specified by the Secretary, all costs 21 |
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520 | 520 | | and payments related to covered outpatient 22 |
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521 | 521 | | drugs and accompanying administrative 23 |
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522 | 522 | | services (as described in clause (ii)) in-24 |
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523 | 523 | | curred, received, or made by the entity or 25 |
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525 | 525 | | ssavage on LAPJG3WLY3PROD with BILLS 19 |
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526 | 526 | | •S 927 IS |
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527 | 527 | | the PBM, broken down (as specified by the 1 |
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528 | 528 | | Secretary), to the extent such costs and 2 |
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529 | 529 | | payments are attributable to an individual 3 |
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530 | 530 | | covered outpatient drug, by each such 4 |
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531 | 531 | | drug, including any ingredient costs, pro-5 |
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532 | 532 | | fessional dispensing fees, administrative 6 |
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533 | 533 | | fees (as described in clause (ii)), post-sale 7 |
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534 | 534 | | and post-invoice fees, discounts, or related 8 |
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535 | 535 | | adjustments such as direct and indirect re-9 |
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536 | 536 | | muneration fees, and any and all other re-10 |
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537 | 537 | | muneration, as defined by the Secretary; 11 |
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538 | 538 | | and 12 |
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539 | 539 | | ‘‘(iv) any form of spread pricing 13 |
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540 | 540 | | whereby any amount charged or claimed by 14 |
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541 | 541 | | the entity or the PBM (as applicable) that 15 |
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542 | 542 | | exceeds the amount paid to the pharmacies 16 |
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543 | 543 | | or providers on behalf of the State or enti-17 |
---|
544 | 544 | | ty, including any post-sale or post-invoice 18 |
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545 | 545 | | fees, discounts, or related adjustments 19 |
---|
546 | 546 | | such as direct and indirect remuneration 20 |
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547 | 547 | | fees or assessments, as defined by the Sec-21 |
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548 | 548 | | retary, (after allowing for an administra-22 |
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549 | 549 | | tive fee as described in clause (ii)) is not 23 |
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550 | 550 | | allowable for purposes of claiming Federal 24 |
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551 | 551 | | matching payments under this title. 25 |
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552 | 552 | | VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 |
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553 | 553 | | ssavage on LAPJG3WLY3PROD with BILLS 20 |
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554 | 554 | | •S 927 IS |
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555 | 555 | | ‘‘(B) PUBLICATION OF INFORMATION .— 1 |
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556 | 556 | | The Secretary shall publish, not less frequently 2 |
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557 | 557 | | than on an annual basis and in a manner that 3 |
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558 | 558 | | does not disclose the identity of a particular 4 |
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559 | 559 | | covered entity or organization, information re-5 |
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560 | 560 | | ceived by the Secretary pursuant to subpara-6 |
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561 | 561 | | graph (A)(iii)(III) that is broken out by State 7 |
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562 | 562 | | and by each of the following categories of cov-8 |
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563 | 563 | | ered entity within each such State: 9 |
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564 | 564 | | ‘‘(i) Covered entities described in sub-10 |
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565 | 565 | | paragraph (A) of section 340B(a)(4) of the 11 |
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566 | 566 | | Public Health Service Act. 12 |
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567 | 567 | | ‘‘(ii) Covered entities described in sub-13 |
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568 | 568 | | paragraphs (B) through (K) of such sec-14 |
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569 | 569 | | tion. 15 |
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570 | 570 | | ‘‘(iii) Covered entities described in 16 |
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571 | 571 | | subparagraph (L) of such section. 17 |
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572 | 572 | | ‘‘(iv) Covered entities described in 18 |
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573 | 573 | | subparagraph (M) of such section. 19 |
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574 | 574 | | ‘‘(v) Covered entities described in sub-20 |
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575 | 575 | | paragraph (N) of such section. 21 |
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576 | 576 | | ‘‘(vi) Covered entities described in 22 |
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577 | 577 | | subparagraph (O) of such section.’’; and 23 |
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579 | 579 | | ssavage on LAPJG3WLY3PROD with BILLS 21 |
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580 | 580 | | •S 927 IS |
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581 | 581 | | (2) in subsection (k), as amended by section 1 |
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582 | 582 | | 2(b), by adding at the end the following new para-2 |
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583 | 583 | | graph: 3 |
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584 | 584 | | ‘‘(14) P |
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585 | 585 | | HARMACY BENEFIT MANAGER .—The 4 |
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586 | 586 | | term ‘pharmacy benefit manager’ means any person 5 |
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587 | 587 | | or entity that, either directly or through an inter-6 |
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588 | 588 | | mediary, acts as a price negotiator or group pur-7 |
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589 | 589 | | chaser on behalf of a State, managed care entity (as 8 |
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590 | 590 | | defined in section 1903(m)(9)(D)), or other specified 9 |
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591 | 591 | | entity (as so defined), or manages the prescription 10 |
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592 | 592 | | drug benefits provided by a State, managed care en-11 |
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593 | 593 | | tity, or other specified entity, including the proc-12 |
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594 | 594 | | essing and payment of claims for prescription drugs, 13 |
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595 | 595 | | the performance of drug utilization review, the proc-14 |
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596 | 596 | | essing of drug prior authorization requests, the man-15 |
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597 | 597 | | aging of appeals or grievances related to the pre-16 |
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598 | 598 | | scription drug benefits, contracting with pharmacies, 17 |
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599 | 599 | | controlling the cost of covered outpatient drugs, or 18 |
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600 | 600 | | the provision of services related thereto. Such term 19 |
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601 | 601 | | includes any person or entity that acts as a price ne-20 |
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602 | 602 | | gotiator (with regard to payment amounts to phar-21 |
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603 | 603 | | macies and providers for a covered outpatient drug 22 |
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604 | 604 | | or the net cost of the drug) or group purchaser on 23 |
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605 | 605 | | behalf of a State, managed care entity, or other 24 |
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606 | 606 | | specified entity or that carries out 1 or more of the 25 |
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607 | 607 | | VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 |
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608 | 608 | | ssavage on LAPJG3WLY3PROD with BILLS 22 |
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609 | 609 | | •S 927 IS |
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610 | 610 | | other activities described in the preceding sentence, 1 |
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611 | 611 | | irrespective of whether such person or entity calls 2 |
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612 | 612 | | itself a pharmacy benefit manager.’’. 3 |
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613 | 613 | | (b) C |
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614 | 614 | | ONFORMINGAMENDMENTS.—Section 1903(m) 4 |
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615 | 615 | | of such Act (42 U.S.C. 1396b(m)) is amended— 5 |
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616 | 616 | | (1) in paragraph (2)(A)(xiii)— 6 |
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617 | 617 | | (A) by striking ‘‘and (III)’’ and inserting 7 |
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618 | 618 | | ‘‘(III)’’; 8 |
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619 | 619 | | (B) by inserting before the period at the 9 |
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620 | 620 | | end the following: ‘‘, and (IV) if the contract in-10 |
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621 | 621 | | cludes provisions making the entity responsible 11 |
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622 | 622 | | for coverage of covered outpatient drugs, the 12 |
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623 | 623 | | entity shall comply with the requirements of 13 |
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624 | 624 | | section 1927(e)(6)’’; and 14 |
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625 | 625 | | (C) by moving the margin 2 ems to the 15 |
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626 | 626 | | left; and 16 |
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627 | 627 | | (2) by adding at the end the following new 17 |
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628 | 628 | | paragraph: 18 |
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629 | 629 | | ‘‘(10) No payment shall be made under this 19 |
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630 | 630 | | title to a State with respect to expenditures incurred 20 |
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631 | 631 | | by the State for payment for services provided by an 21 |
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632 | 632 | | other specified entity (as defined in paragraph 22 |
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633 | 633 | | (9)(D)(iii)) unless such services are provided in ac-23 |
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634 | 634 | | cordance with a contract between the State and such 24 |
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635 | 635 | | VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 |
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636 | 636 | | ssavage on LAPJG3WLY3PROD with BILLS 23 |
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637 | 637 | | •S 927 IS |
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638 | 638 | | entity which satisfies the requirements of paragraph 1 |
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639 | 639 | | (2)(A)(xiii).’’. 2 |
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640 | 640 | | (c) E |
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641 | 641 | | FFECTIVEDATE.—The amendments made by 3 |
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642 | 642 | | this section shall apply to contracts between States and 4 |
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643 | 643 | | managed care entities, other specified entities, or phar-5 |
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644 | 644 | | macy benefit managers that have an effective date begin-6 |
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645 | 645 | | ning on or after the date that is 18 months after the date 7 |
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646 | 646 | | of enactment of this Act. 8 |
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647 | 647 | | (d) I |
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648 | 648 | | MPLEMENTATION.— 9 |
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649 | 649 | | (1) I |
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650 | 650 | | N GENERAL.—Notwithstanding any other 10 |
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651 | 651 | | provision of law, the Secretary of Health and 11 |
---|
652 | 652 | | Human Services may implement the amendments 12 |
---|
653 | 653 | | made by this section by program instruction or oth-13 |
---|
654 | 654 | | erwise. 14 |
---|
655 | 655 | | (2) N |
---|
656 | 656 | | ONAPPLICATION OF ADMINISTRATIVE PRO -15 |
---|
657 | 657 | | CEDURE ACT.—Implementation of the amendments 16 |
---|
658 | 658 | | made by this section shall be exempt from the re-17 |
---|
659 | 659 | | quirements of section 553 of title 5, United States 18 |
---|
660 | 660 | | Code. 19 |
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661 | 661 | | (e) N |
---|
662 | 662 | | ONAPPLICATION OF PAPERWORKREDUCTION 20 |
---|
663 | 663 | | A |
---|
664 | 664 | | CT.—Chapter 35 of title 44, United States Code, shall 21 |
---|
665 | 665 | | not apply to any data collection undertaken by the Sec-22 |
---|
666 | 666 | | retary of Health and Human Services under section 23 |
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667 | 667 | | VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S927.IS S927 |
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668 | 668 | | ssavage on LAPJG3WLY3PROD with BILLS 24 |
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669 | 669 | | •S 927 IS |
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670 | 670 | | 1927(e) of the Social Security Act (42 U.S.C. 1396r– 1 |
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671 | 671 | | 8(e)), as amended by this section. 2 |
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672 | 672 | | Æ |
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673 | 673 | | VerDate Sep 11 2014 17:09 Mar 28, 2025 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6301 E:\BILLS\S927.IS S927 |
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674 | 674 | | ssavage on LAPJG3WLY3PROD with BILLS |
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