8 | 7 | | Citations Affected: IC 16-18; IC 16-40. |
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9 | 8 | | Synopsis: 340B drug program report. Requires certain entities |
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10 | 9 | | authorized to participate in the federal 340B Drug Pricing Program to |
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11 | 10 | | annually report specified data to the Indiana department of health (state |
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12 | 11 | | department). Requires the state department to submit a report of the |
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13 | 12 | | aggregated data to the legislative council and post the report on the |
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14 | 13 | | state department's website. |
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15 | 14 | | Effective: July 1, 2025. |
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16 | 15 | | Charbonneau, Crider, Johnson T, |
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17 | 16 | | Deery, Becker, Busch |
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18 | 17 | | (HOUSE SPONSORS — BARRETT, MCGUIRE, ISA) |
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19 | 18 | | January 8, 2025, read first time and referred to Committee on Health and Provider |
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20 | 19 | | Services. |
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21 | 20 | | January 29, 2025, amended, reported favorably — Do Pass. |
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22 | 21 | | February 3, 2025, read second time, ordered engrossed. Engrossed. |
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23 | 22 | | February 4, 2025, read third time, passed. Yeas 49, nays 1. |
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24 | 23 | | HOUSE ACTION |
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25 | 24 | | March 3, 2025, read first time and referred to Committee on Public Health. |
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26 | 25 | | March 25, 2025, amended, reported — Do Pass. |
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30 | 27 | | First Regular Session of the 124th General Assembly (2025) |
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31 | 28 | | PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana |
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32 | 29 | | Constitution) is being amended, the text of the existing provision will appear in this style type, |
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33 | 30 | | additions will appear in this style type, and deletions will appear in this style type. |
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34 | 31 | | Additions: Whenever a new statutory provision is being enacted (or a new constitutional |
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35 | 32 | | provision adopted), the text of the new provision will appear in this style type. Also, the |
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36 | 33 | | word NEW will appear in that style type in the introductory clause of each SECTION that adds |
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37 | 34 | | a new provision to the Indiana Code or the Indiana Constitution. |
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38 | 35 | | Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts |
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39 | 36 | | between statutes enacted by the 2024 Regular Session of the General Assembly. |
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40 | 37 | | ENGROSSED |
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41 | 38 | | SENATE BILL No. 118 |
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42 | 39 | | A BILL FOR AN ACT to amend the Indiana Code concerning |
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43 | 40 | | health. |
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44 | 41 | | Be it enacted by the General Assembly of the State of Indiana: |
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45 | 42 | | 1 SECTION 1. IC 16-18-2-0.2 IS ADDED TO THE INDIANA CODE |
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46 | 43 | | 2 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY |
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47 | 44 | | 3 1, 2025]: Sec. 0.2. "340B covered entity", for purposes of |
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48 | 45 | | 4 IC 16-40-6, has the meaning set forth in IC 16-40-6-1. |
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49 | 46 | | 5 SECTION 2. IC 16-18-2-0.3 IS ADDED TO THE INDIANA CODE |
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50 | 47 | | 6 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY |
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51 | 48 | | 7 1, 2025]: Sec. 0.3. "340B program", for purposes of IC 16-40-6, has |
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52 | 49 | | 8 the meaning set forth in IC 16-40-6-2. |
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53 | 50 | | 9 SECTION 3. IC 16-18-2-52.5 IS AMENDED TO READ AS |
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54 | 51 | | 10 FOLLOWS [EFFECTIVE JULY 1, 2025]: Sec. 52.5. (a) "Charity care", |
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55 | 52 | | 11 for purposes of IC 16-21-6, and IC 16-21-9, and IC 16-40-6, means the |
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56 | 53 | | 12 unreimbursed cost to a hospital of providing, funding, or otherwise |
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57 | 54 | | 13 financially supporting health care services: |
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58 | 55 | | 14 (1) to a person classified by the hospital as financially indigent or |
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59 | 56 | | 15 medically indigent on an inpatient or outpatient basis; and |
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60 | 57 | | 16 (2) to financially indigent patients through other nonprofit or |
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61 | 58 | | 17 public outpatient clinics, hospitals, or health care organizations. |
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62 | 59 | | ES 118—LS 6292/DI 104 2 |
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63 | 60 | | 1 (b) As used in this section, "financially indigent" means an |
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64 | 61 | | 2 uninsured or underinsured person who is accepted for care with no |
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65 | 62 | | 3 obligation or a discounted obligation to pay for the services rendered |
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66 | 63 | | 4 based on the hospital's financial criteria and procedure used to |
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67 | 64 | | 5 determine if a patient is eligible for charity care. The criteria and |
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68 | 65 | | 6 procedure must include income levels and means testing indexed to the |
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69 | 66 | | 7 federal poverty guidelines. A hospital may determine that a person is |
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70 | 67 | | 8 financially or medically indigent under the hospital's eligibility system |
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71 | 68 | | 9 after health care services are provided. |
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72 | 69 | | 10 (c) As used in this section, "medically indigent" means a person |
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73 | 70 | | 11 whose medical or hospital bills after payment by third party payors |
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74 | 71 | | 12 exceed a specified percentage of the patient's annual gross income as |
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75 | 72 | | 13 determined in accordance with the hospital's eligibility system, and |
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76 | 73 | | 14 who is financially unable to pay the remaining bill. |
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77 | 74 | | 15 SECTION 4. IC 16-40-6 IS ADDED TO THE INDIANA CODE AS |
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78 | 75 | | 16 A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE JULY |
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79 | 76 | | 17 1, 2025]: |
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80 | 77 | | 18 Chapter 6. 340B Drug Pricing Program Reporting |
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81 | 78 | | 19 Sec. 1. (a) As used in this chapter, "340B covered entity" means |
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82 | | - | 20 an entity described in 42 U.S.C. 256b(a)(4)(L) through 42 U.S.C. |
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83 | | - | 21 256b(a)(4)(O) that: |
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84 | | - | 22 (1) is authorized to participate in the federal 340B Drug |
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85 | | - | 23 Pricing Program under Section 340B of the federal Public |
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86 | | - | 24 Health Service Act (42 U.S.C. 256b(a)(4)); and |
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87 | | - | 25 (2) has a service address in Indiana as of January 1 of the |
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88 | | - | 26 reporting year. |
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89 | | - | 27 (b) The term does not include an entity that is a recipient of a |
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90 | | - | 28 grant from the federal Health Resources and Services |
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91 | | - | 29 Administration. |
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92 | | - | 30 Sec. 2. As used in this chapter, "340B program" refers to the |
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93 | | - | 31 federal 340B Drug Pricing Program established under 42 U.S.C. |
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94 | | - | 32 256b. |
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95 | | - | 33 Sec. 3. (a) Before April 1 of each year, a 340B covered entity |
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96 | | - | 34 shall report the following information and transactions to the state |
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97 | | - | 35 department concerning the 340B covered entity's participation in |
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98 | | - | 36 or participation on behalf of the 340B covered entity in the federal |
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99 | | - | 37 340B program for the previous calendar year: |
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100 | | - | 38 (1) The: |
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101 | | - | 39 (A) name; |
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102 | | - | 40 (B) service address; |
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103 | | - | 41 (C) 340B program identification number; and |
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104 | | - | 42 (D) designation of entity type, as specified in 42 U.S.C. |
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| 79 | + | 20 an entity authorized to participate in the federal 340B Drug |
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| 80 | + | 21 Pricing Program under Section 340B(a)(4) of the federal Public |
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| 81 | + | 22 Health Service Act (42 U.S.C. 256b(a)(4)) and that has a service |
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| 82 | + | 23 address in Indiana as of January 1 of the reporting year. |
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| 83 | + | 24 (b) Except as provided in subsection (c), the term includes all |
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| 84 | + | 25 entity types and grantees, including a facility that is identified as a |
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| 85 | + | 26 child site or grantee associated site under the 340B program. |
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| 86 | + | 27 (c) The term does not include the following: |
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| 87 | + | 28 (1) An entity that is a recipient of a grant from the federal |
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| 88 | + | 29 Health Resources and Services Administration. |
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| 89 | + | 30 (2) A federally qualified health center (as defined in 42 U.S.C. |
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| 90 | + | 31 1396d(l)(2)(B)). |
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| 91 | + | 32 Sec. 2. As used in this chapter, "340B program" refers to the |
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| 92 | + | 33 federal 340B Drug Pricing Program established under 42 U.S.C. |
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| 93 | + | 34 256b. |
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| 94 | + | 35 Sec. 3. (a) Before April 1 of each year, a 340B covered entity |
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| 95 | + | 36 shall report the following information and transactions to the state |
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| 96 | + | 37 department concerning the 340B covered entity's participation in |
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| 97 | + | 38 or participation on behalf of the 340B covered entity in the federal |
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| 98 | + | 39 340B program for the previous calendar year: |
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| 99 | + | 40 (1) The: |
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| 100 | + | 41 (A) name; |
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| 101 | + | 42 (B) service address; |
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106 | | - | 1 256b(a)(4); |
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107 | | - | 2 of the 340B covered entity. |
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108 | | - | 3 (2) The aggregate acquisition cost for all prescription drugs |
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109 | | - | 4 obtained under the 340B program and dispensed or |
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110 | | - | 5 administered to patients. |
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111 | | - | 6 (3) The aggregate payment amount received for all drugs |
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112 | | - | 7 obtained under the 340B program and dispensed or |
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113 | | - | 8 administered to patients. |
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114 | | - | 9 (4) The aggregate payment made to pharmacies under |
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115 | | - | 10 contract to dispense drugs obtained under the 340B program. |
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116 | | - | 11 (5) The number of claims for prescription drugs described in |
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117 | | - | 12 subdivision (3). |
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118 | | - | 13 (6) How the 340B covered entity uses any savings from |
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119 | | - | 14 participating in the 340B program, including the amount of |
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120 | | - | 15 savings used for the provision of charity care, community |
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121 | | - | 16 benefits, or a similar program of providing unreimbursed or |
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122 | | - | 17 subsidized health care. |
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123 | | - | 18 (7) The aggregate payments made to any other entity that is |
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124 | | - | 19 not a 340B covered entity and is not a contract pharmacy as |
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125 | | - | 20 described in subdivision (4) for managing any aspect of the |
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126 | | - | 21 340B covered entity's 340B program. |
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127 | | - | 22 (8) The aggregate payment made for any other administering |
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128 | | - | 23 expense for the 340B program. |
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129 | | - | 24 (9) The aggregate number of prescription drugs dispensed or |
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130 | | - | 25 administered to patients for which a payment was reported |
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131 | | - | 26 under subdivision (3). |
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132 | | - | 27 (10) The percentage of the 340B covered entity's claims that |
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133 | | - | 28 were for prescription drugs obtained under the 340B |
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134 | | - | 29 program. |
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135 | | - | 30 (11) The number and percentage of low income patients of the |
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136 | | - | 31 340B covered entity that were served by a sliding fee scale for |
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137 | | - | 32 a prescription drug dispensed or administered under the 340B |
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138 | | - | 33 program. |
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139 | | - | 34 (12) The 340B covered entity's total operating costs. |
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140 | | - | 35 (13) The 340B covered entity's total costs for charity care. |
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141 | | - | 36 (14) A copy of the 340B covered entity's financial assistance |
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142 | | - | 37 policy for the reporting year. |
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143 | | - | 38 (b) The information required to be reported under subsection |
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144 | | - | 39 (a)(3) through (a)(5) must, to the extent feasible, be reported by |
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145 | | - | 40 payer type, including the following: |
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146 | | - | 41 (1) Commercial. |
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147 | | - | 42 (2) Medicaid. |
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| 103 | + | 1 (C) 340B program identification number; and |
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| 104 | + | 2 (D) designation of entity type, as specified in 42 U.S.C. |
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| 105 | + | 3 256b(a)(4); |
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| 106 | + | 4 of the 340B covered entity. |
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| 107 | + | 5 (2) The aggregate acquisition cost for all prescription drugs |
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| 108 | + | 6 obtained through a contract pharmacy under the 340B |
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| 109 | + | 7 program. |
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| 110 | + | 8 (3) The aggregate payment amount received for all drugs |
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| 111 | + | 9 obtained under the 340B program and dispensed to patients |
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| 112 | + | 10 through a contract pharmacy. |
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| 113 | + | 11 (4) The aggregate payment made to pharmacies under |
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| 114 | + | 12 contract to dispense drugs obtained under the 340B program. |
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| 115 | + | 13 (5) The number of claims for prescription drugs described in |
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| 116 | + | 14 subdivision (3). |
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| 117 | + | 15 (6) How the 340B covered entity uses any savings from |
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| 118 | + | 16 participating in the 340B program, including the amount of |
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| 119 | + | 17 savings used for the provision of charity care, community |
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| 120 | + | 18 benefits, or a similar program of providing unreimbursed or |
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| 121 | + | 19 subsidized health care. |
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| 122 | + | 20 (7) The aggregate payments made to any other entity that is |
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| 123 | + | 21 not a 340B covered entity and is not a contract pharmacy as |
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| 124 | + | 22 described in subdivision (4) for managing any aspect of the |
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| 125 | + | 23 340B covered entity's 340B program. |
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| 126 | + | 24 (8) The aggregate payment made for any other administering |
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| 127 | + | 25 expense for the 340B program. |
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| 128 | + | 26 (9) The aggregate number of prescription drugs dispensed to |
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| 129 | + | 27 patients for which a payment was reported under subdivision |
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| 130 | + | 28 (3). |
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| 131 | + | 29 (10) The 340B covered entity's total operating costs. |
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| 132 | + | 30 (11) The 340B covered entity's total costs for charity care. |
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| 133 | + | 31 (12) A copy of the 340B covered entity's financial assistance |
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| 134 | + | 32 policy for the reporting year. |
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| 135 | + | 33 (b) The information required to be reported under subsection |
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| 136 | + | 34 (a)(3) through (a)(5) must, to the extent feasible, be reported by |
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| 137 | + | 35 payer type, including the following: |
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| 138 | + | 36 (1) Commercial. |
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| 139 | + | 37 (2) Medicaid. |
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| 140 | + | 38 (3) Medicare. |
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| 141 | + | 39 (4) Uninsured. |
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| 142 | + | 40 (c) The data submitted in the reports required under subsection |
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| 143 | + | 41 (a) is confidential and is not available for public inspection. |
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| 144 | + | 42 (d) Before November 15 of each year, the state department shall |
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163 | 151 | | ES 118—LS 6292/DI 104 5 |
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164 | 152 | | COMMITTEE REPORT |
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165 | 153 | | Mr. President: The Senate Committee on Health and Provider |
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166 | 154 | | Services, to which was referred Senate Bill No. 118, has had the same |
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167 | 155 | | under consideration and begs leave to report the same back to the |
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168 | 156 | | Senate with the recommendation that said bill be AMENDED as |
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169 | 157 | | follows: |
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170 | 158 | | Page 1, between lines 4 and 5, begin a new paragraph and insert: |
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171 | 159 | | "SECTION 2. IC 16-18-2-0.3 IS ADDED TO THE INDIANA |
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172 | 160 | | CODE AS A NEW SECTION TO READ AS FOLLOWS |
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173 | 161 | | [EFFECTIVE JULY 1, 2025]: Sec. 0.3. "340B program", for |
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174 | 162 | | purposes of IC 16-40-6, has the meaning set forth in IC 16-40-6-2.". |
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175 | 163 | | Page 2, delete lines 11 through 14. |
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176 | 164 | | Page 2, line 19, after "1." insert "(a)". |
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177 | 165 | | Page 2, line 22, delete "and includes any pharmacy" and insert "and |
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178 | 166 | | that has a service address in Indiana as of January 1 of the |
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179 | 167 | | reporting year. |
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180 | 168 | | (b) The term includes all entity types and grantees, including a |
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181 | 169 | | facility that is identified as a child site or grantee associated site |
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182 | 170 | | under the 340B program. |
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183 | 171 | | Sec. 2. As used in this chapter, "340B program" refers to the |
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184 | 172 | | federal 340B Drug Pricing Program established under 42 U.S.C. |
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185 | 173 | | 256b.". |
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186 | 174 | | Page 2, delete lines 23 through 24. |
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187 | 175 | | Page 2, line 25, delete "2." and insert "3.". |
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188 | 176 | | Page 2, line 26, after "information" insert "and transactions". |
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189 | 177 | | Page 2, line 27, after "in" insert "or participation on behalf of the |
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190 | 178 | | 340B covered entity in". |
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191 | 179 | | Page 2, line 28, delete "Drug Pricing Program" and insert |
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192 | 180 | | "program". |
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193 | 181 | | Page 2, delete line 29, begin a new line block indented and insert: |
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194 | 182 | | "(1) The: |
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195 | 183 | | (A) name; |
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196 | 184 | | (B) service address; |
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197 | 185 | | (C) 340B program identification number; and |
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198 | 186 | | (D) designation of entity type, as specified in 42 U.S.C. |
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199 | 187 | | 256b(a)(4); |
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200 | 188 | | of the 340B covered entity.". |
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201 | 189 | | Page 2, line 30, after "for" insert "all". |
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202 | 190 | | Page 2, line 32, after "for" insert "all". |
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203 | 191 | | Page 2, line 33, after "dispensed" insert "or administered". |
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204 | 192 | | Page 2, after line 42, begin a new line block indented and insert: |
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205 | 193 | | ES 118—LS 6292/DI 104 6 |
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206 | 194 | | "(7) The aggregate payments made to any other entity that is |
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207 | 195 | | not a 340B covered entity and is not a contract pharmacy as |
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208 | 196 | | described in subdivision (4) for managing any aspect of the |
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209 | 197 | | 340B covered entity's 340B program. |
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210 | 198 | | (8) The aggregate payment made for any other administering |
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211 | 199 | | expense for the 340B program. |
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212 | 200 | | (9) The aggregate number of prescription drugs administered |
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213 | 201 | | or dispensed to patients for which a payment was reported |
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214 | 202 | | under subdivision (3). |
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215 | 203 | | (10) The percentage of the 340B covered entity's claims that |
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216 | 204 | | were for prescription drugs obtained under the 340B |
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217 | 205 | | program. |
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218 | 206 | | (11) The number and percentage of low income patients of the |
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219 | 207 | | 340B covered entity that were served by a sliding fee scale for |
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220 | 208 | | a prescription drug dispensed or administered under the 340B |
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221 | 209 | | program. |
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222 | 210 | | (12) The 340B covered entity's total operating costs. |
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223 | 211 | | (13) The 340B covered entity's total costs for charity care. |
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224 | 212 | | (14) A copy of the 340B covered entity's financial assistance |
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225 | 213 | | policy for the reporting year.". |
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226 | 214 | | Page 3, between lines 5 and 6, begin a new line block indented and |
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227 | 215 | | insert: |
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228 | 216 | | "(4) Uninsured.". |
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229 | 217 | | Page 3, after line 13, begin a new paragraph and insert: |
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230 | 218 | | "SECTION 5. IC 27-1-44.5-11.5 IS ADDED TO THE INDIANA |
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231 | 219 | | CODE AS A NEW SECTION TO READ AS FOLLOWS |
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232 | 220 | | [EFFECTIVE JULY 1, 2025]: Sec. 11.5. (a) The following must |
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233 | 221 | | submit information to the data base concerning prescription drug |
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234 | 222 | | prices: |
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235 | 223 | | (1) A health payer, using patient data claims. |
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236 | 224 | | (2) A pharmacy. |
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237 | 225 | | (3) A nonprofit hospital pharmacy. |
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238 | 226 | | (4) A 340B covered entity (as defined in IC 16-40-6-1).". |
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239 | 227 | | Renumber all SECTIONS consecutively. |
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240 | 228 | | and when so amended that said bill do pass. |
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241 | 229 | | (Reference is to SB 118 as introduced.) |
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242 | 230 | | CHARBONNEAU, Chairperson |
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243 | 231 | | Committee Vote: Yeas 11, Nays 0. |
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244 | 232 | | ES 118—LS 6292/DI 104 7 |
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245 | 233 | | COMMITTEE REPORT |
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246 | 234 | | Mr. Speaker: Your Committee on Public Health, to which was |
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247 | 235 | | referred Senate Bill 118, has had the same under consideration and |
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248 | 236 | | begs leave to report the same back to the House with the |
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249 | 237 | | recommendation that said bill be amended as follows: |
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250 | 238 | | Page 2, line 24, delete "The" and insert "Except as provided in |
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251 | 239 | | subsection (c), the". |
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252 | 240 | | Page 2, between lines 26 and 27, begin a new paragraph and insert: |
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253 | 241 | | "(c) The term does not include the following: |
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254 | 242 | | (1) An entity that is a recipient of a grant from the federal |
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255 | 243 | | Health Resources and Services Administration. |
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256 | 244 | | (2) A federally qualified health center (as defined in 42 U.S.C. |
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257 | 245 | | 1396d(l)(2)(B)).". |
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258 | 246 | | Page 3, line 1, after "obtained" insert "through a contract |
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259 | 247 | | pharmacy". |
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260 | 248 | | Page 3, line 3, delete "or". |
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261 | 249 | | Page 3, line 4, delete "administered to patients." and insert "to |
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262 | 250 | | patients through a contract pharmacy.". |
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263 | 251 | | Page 3, line 12, after "unreimbursed" insert "or subsidized". |
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264 | 252 | | Page 3, line 13, delete "care to the indigent." and insert "care.". |
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265 | 253 | | Page 3, line 20, delete "administered". |
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266 | 254 | | Page 3, line 21, delete "or". |
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267 | 255 | | Page 3, delete lines 23 through 29. |
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268 | 256 | | Page 3, line 30, delete "(12)" and insert "(10)". |
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269 | 257 | | Page 3, line 31, delete "(13)" and insert "(11)". |
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270 | 258 | | Page 3, line 32, delete "(14)" and insert "(12)". |
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271 | 259 | | Page 3, line 35, delete "(a) must" and insert "(a)(3) through (a)(5) |
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272 | 260 | | must, to the extent feasible,". |
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273 | 261 | | Page 4, delete lines 6 through 14. |
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274 | 262 | | and when so amended that said bill do pass. |
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275 | 263 | | (Reference is to SB 118 as printed January 30, 2025.) |
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276 | 264 | | BARRETT |
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277 | 265 | | Committee Vote: yeas 11, nays 0. |
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278 | | - | ES 118—LS 6292/DI 104 8 |
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279 | | - | HOUSE MOTION |
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280 | | - | Mr. Speaker: I move that Engrossed Senate Bill 118 be amended to |
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281 | | - | read as follows: |
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282 | | - | Page 2, delete lines 19 through 31, begin a new paragraph and |
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283 | | - | insert: |
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284 | | - | "Sec. 1. (a) As used in this chapter, "340B covered entity" |
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285 | | - | means an entity described in 42 U.S.C. 256b(a)(4)(L) through 42 |
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286 | | - | U.S.C. 256b(a)(4)(O) that: |
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287 | | - | (1) is authorized to participate in the federal 340B Drug |
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288 | | - | Pricing Program under Section 340B of the federal Public |
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289 | | - | Health Service Act (42 U.S.C. 256b(a)(4)); and |
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290 | | - | (2) has a service address in Indiana as of January 1 of the |
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291 | | - | reporting year. |
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292 | | - | (b) The term does not include an entity that is a recipient of a |
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293 | | - | grant from the federal Health Resources and Services |
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294 | | - | Administration.". |
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295 | | - | Page 3, line 6, delete "through a contract pharmacy". |
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296 | | - | Page 3, line 7, delete "program." and insert "program and |
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297 | | - | dispensed or administered to patients.". |
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298 | | - | Page 3, line 9, delete "to patients" and insert "or administered to |
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299 | | - | patients.". |
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300 | | - | Page 3, delete line 10. |
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301 | | - | Page 3, line 26, after "dispensed" insert "or administered". |
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302 | | - | Page 3, between lines 28 and 29, begin a new line block indented |
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303 | | - | and insert: |
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304 | | - | "(10) The percentage of the 340B covered entity's claims that |
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305 | | - | were for prescription drugs obtained under the 340B |
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306 | | - | program. |
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307 | | - | (11) The number and percentage of low income patients of the |
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308 | | - | 340B covered entity that were served by a sliding fee scale for |
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309 | | - | a prescription drug dispensed or administered under the 340B |
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310 | | - | program.". |
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311 | | - | Page 3, line 29, delete "(10)" and insert "(12)". |
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312 | | - | Page 3, line 30, delete "(11)" and insert "(13)". |
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313 | | - | Page 3, line 31, delete "(12)" and insert "(14)". |
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314 | | - | Page 4, after line 5, begin a new paragraph and insert: |
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315 | | - | "Sec. 4. A 340B covered entity that fails to provide the |
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316 | | - | information required under section 3 of this chapter by the date |
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317 | | - | required shall pay to the state department a fine of one thousand |
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318 | | - | dollars ($1,000) per day for which the information is past due.". |
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319 | | - | ES 118—LS 6292/DI 104 9 |
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320 | | - | (Reference is to ESB 118 as printed March 25, 2025.) |
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321 | | - | MCGUIRE |
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