1 | 1 | | I |
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2 | 2 | | 119THCONGRESS |
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3 | 3 | | 1 |
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4 | 4 | | STSESSION H. R. 2636 |
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5 | 5 | | To provide for appropriate cost-sharing for individuals 26 years of age or |
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6 | 6 | | younger for insulin products covered under private health plans. |
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7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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8 | 8 | | APRIL3, 2025 |
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9 | 9 | | Mr. L |
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10 | 10 | | ANDSMAN(for himself, Ms. NORTON, Ms. DEANof Pennsylvania, Mr. |
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11 | 11 | | M |
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12 | 12 | | CGARVEY, Mr. THOMPSONof Mississippi, and Mr. GOTTHEIMER) intro- |
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13 | 13 | | duced the following bill; which was referred to the Committee on Energy |
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14 | 14 | | and Commerce, and in addition to the Committees on Ways and Means, |
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15 | 15 | | and Education and Workforce, for a period to be subsequently deter- |
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16 | 16 | | mined by the Speaker, in each case for consideration of such provisions |
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17 | 17 | | as fall within the jurisdiction of the committee concerned |
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18 | 18 | | A BILL |
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19 | 19 | | To provide for appropriate cost-sharing for individuals 26 |
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20 | 20 | | years of age or younger for insulin products covered |
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21 | 21 | | under private health plans. |
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22 | 22 | | Be it enacted by the Senate and House of Representa-1 |
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23 | 23 | | tives of the United States of America in Congress assembled, 2 |
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24 | 24 | | SECTION 1. SHORT TITLE. 3 |
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25 | 25 | | This Act may be cited as the ‘‘Making Insulin Afford-4 |
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26 | 26 | | able for All Children Act’’. 5 |
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27 | 27 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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28 | 28 | | mprince on LAP1J3WLY3PROD with $$_JOB 2 |
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29 | 29 | | •HR 2636 IH |
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30 | 30 | | SEC. 2. APPROPRIATE COST-SHARING FOR INDIVIDUALS 26 1 |
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31 | 31 | | YEARS OF AGE OR YOUNGER FOR INSULIN 2 |
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32 | 32 | | PRODUCTS COVERED UNDER PRIVATE 3 |
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33 | 33 | | HEALTH PLANS. 4 |
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34 | 34 | | (a) I |
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35 | 35 | | NGENERAL.—Part D of title XXVII of the Pub-5 |
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36 | 36 | | lic Health Service Act (42 U.S.C. 300gg–111 et seq.) is 6 |
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37 | 37 | | amended by adding at the end the following: 7 |
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38 | 38 | | ‘‘SEC. 2799A–11. REQUIREMENTS WITH RESPECT TO COST- 8 |
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39 | 39 | | SHARING FOR CERTAIN INSULIN PRODUCTS. 9 |
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40 | 40 | | ‘‘(a) I |
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41 | 41 | | NGENERAL.—For plan years beginning on or 10 |
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42 | 42 | | after January 1, 2026, a group health plan or health in-11 |
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43 | 43 | | surance issuer offering group or individual health insur-12 |
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44 | 44 | | ance coverage shall, with respect to enrolled individuals 13 |
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45 | 45 | | 26 years of age or younger, provide coverage of selected 14 |
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46 | 46 | | insulin products, and with respect to such products, shall 15 |
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47 | 47 | | not— 16 |
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48 | 48 | | ‘‘(1) apply any deductible; or 17 |
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49 | 49 | | ‘‘(2) impose any cost-sharing in excess of the 18 |
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50 | 50 | | lesser of, per 30-day supply— 19 |
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51 | 51 | | ‘‘(A) $35; or 20 |
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52 | 52 | | ‘‘(B) the amount equal to 25 percent of 21 |
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53 | 53 | | the negotiated price of the selected insulin prod-22 |
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54 | 54 | | uct net of all price concessions received by or on 23 |
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55 | 55 | | behalf of the plan or coverage, including price 24 |
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56 | 56 | | concessions received by or on behalf of third- 25 |
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57 | 57 | | party entities providing services to the plan or 26 |
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58 | 58 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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59 | 59 | | mprince on LAP1J3WLY3PROD with $$_JOB 3 |
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60 | 60 | | •HR 2636 IH |
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61 | 61 | | coverage, such as pharmacy benefit manage-1 |
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62 | 62 | | ment services. 2 |
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63 | 63 | | ‘‘(b) D |
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64 | 64 | | EFINITIONS.—In this section: 3 |
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65 | 65 | | ‘‘(1) S |
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66 | 66 | | ELECTED INSULIN PRODUCTS .—The term 4 |
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67 | 67 | | ‘selected insulin products’ means at least one of each 5 |
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68 | 68 | | dosage form (such as vial, pump, or inhaler dosage 6 |
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69 | 69 | | forms) of each different type (such as rapid-acting, 7 |
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70 | 70 | | short-acting, intermediate-acting, long-acting, ultra 8 |
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71 | 71 | | long-acting, and premixed) of insulin (as defined 9 |
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72 | 72 | | below), when available, as selected by the group 10 |
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73 | 73 | | health plan or health insurance issuer. 11 |
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74 | 74 | | ‘‘(2) I |
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75 | 75 | | NSULIN DEFINED.—The term ‘insulin’ 12 |
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76 | 76 | | means insulin that is licensed under subsection (a) 13 |
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77 | 77 | | or (k) of section 351 and continues to be marketed 14 |
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78 | 78 | | under such section, including any insulin product 15 |
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79 | 79 | | that has been deemed to be licensed under section 16 |
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80 | 80 | | 351(a) pursuant to section 7002(e)(4) of the Bio-17 |
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81 | 81 | | logics Price Competition and Innovation Act of 2009 18 |
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82 | 82 | | and continues to be marketed pursuant to such li-19 |
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83 | 83 | | censure. 20 |
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84 | 84 | | ‘‘(c) R |
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85 | 85 | | ULE OFCONSTRUCTION.—Subsection (a) shall 21 |
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86 | 86 | | not be construed to require coverage of, or prevent a group 22 |
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87 | 87 | | health plan or health insurance coverage from imposing 23 |
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88 | 88 | | cost-sharing other than the levels specified in subsection 24 |
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89 | 89 | | (a) on, insulin products that are not selected insulin prod-25 |
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90 | 90 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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91 | 91 | | mprince on LAP1J3WLY3PROD with $$_JOB 4 |
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92 | 92 | | •HR 2636 IH |
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93 | 93 | | ucts or insulin products for an individual not described 1 |
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94 | 94 | | in subsection (a), to the extent that such coverage is not 2 |
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95 | 95 | | otherwise required and such cost-sharing is otherwise per-3 |
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96 | 96 | | mitted under Federal and applicable State law. 4 |
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97 | 97 | | ‘‘(d) A |
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98 | 98 | | PPLICATION OF COST-SHARINGTOWARDS 5 |
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99 | 99 | | D |
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100 | 100 | | EDUCTIBLES AND OUT-OF-POCKETMAXIMUMS.—Any 6 |
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101 | 101 | | cost-sharing payments made pursuant to subsection (a)(2) 7 |
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102 | 102 | | shall be counted toward any deductible or out-of-pocket 8 |
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103 | 103 | | maximum that applies under the plan or coverage.’’. 9 |
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104 | 104 | | (b) N |
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105 | 105 | | OEFFECT ONOTHERCOST-SHARING.—Section 10 |
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106 | 106 | | 1302(d)(2) of the Patient Protection and Affordable Care 11 |
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107 | 107 | | Act (42 U.S.C. 18022(d)(2)) is amended by adding at the 12 |
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108 | 108 | | end the following new subparagraph: 13 |
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109 | 109 | | ‘‘(D) S |
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110 | 110 | | PECIAL RULE RELATING TO INSU -14 |
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111 | 111 | | LIN COVERAGE.—The exemption of coverage of 15 |
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112 | 112 | | selected insulin products (as defined in section 16 |
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113 | 113 | | 2799A–11(b) of the Public Health Service Act) 17 |
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114 | 114 | | from the application of any deductible pursuant 18 |
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115 | 115 | | to section 2799A–11(a)(1) of such Act, section 19 |
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116 | 116 | | 726(a)(1) of the Employee Retirement Income 20 |
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117 | 117 | | Security Act of 1974, or section 9826(a)(1) of 21 |
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118 | 118 | | the Internal Revenue Code of 1986 shall not be 22 |
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119 | 119 | | considered when determining the actuarial value 23 |
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120 | 120 | | of a qualified health plan under this sub-24 |
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121 | 121 | | section.’’. 25 |
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122 | 122 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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123 | 123 | | mprince on LAP1J3WLY3PROD with $$_JOB 5 |
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124 | 124 | | •HR 2636 IH |
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125 | 125 | | (c) COVERAGE OF CERTAININSULINPRODUCTS 1 |
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126 | 126 | | U |
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127 | 127 | | NDERCATASTROPHICPLANS.—Section 1302(e) of the 2 |
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128 | 128 | | Patient Protection and Affordable Care Act (42 U.S.C. 3 |
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129 | 129 | | 18022(e)) is amended by adding at the end the following: 4 |
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130 | 130 | | ‘‘(4) C |
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131 | 131 | | OVERAGE OF CERTAIN INSULIN PROD -5 |
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132 | 132 | | UCTS.— 6 |
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133 | 133 | | ‘‘(A) I |
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134 | 134 | | N GENERAL.—Notwithstanding para-7 |
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135 | 135 | | graph (1)(B)(i), a health plan described in 8 |
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136 | 136 | | paragraph (1) shall provide coverage of selected 9 |
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137 | 137 | | insulin products, with respect to an enrolled in-10 |
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138 | 138 | | dividual who is 26 years of age or younger, in 11 |
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139 | 139 | | accordance with section 2799A–11 of the Public 12 |
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140 | 140 | | Health Service Act, before the enrolled indi-13 |
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141 | 141 | | vidual has incurred, during the plan year, cost- 14 |
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142 | 142 | | sharing expenses in an amount equal to the an-15 |
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143 | 143 | | nual limitation in effect under subsection (c)(1) 16 |
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144 | 144 | | for the plan year. 17 |
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145 | 145 | | ‘‘(B) T |
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146 | 146 | | ERMINOLOGY.—For purposes of 18 |
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147 | 147 | | subparagraph (A)— 19 |
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148 | 148 | | ‘‘(i) the term ‘selected insulin prod-20 |
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149 | 149 | | ucts’ has the meaning given such term in 21 |
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150 | 150 | | section 2799A–11(b) of the Public Health 22 |
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151 | 151 | | Service Act; and 23 |
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152 | 152 | | ‘‘(ii) the requirements of section 24 |
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153 | 153 | | 2799A–11 of such Act shall be applied by 25 |
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154 | 154 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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155 | 155 | | mprince on LAP1J3WLY3PROD with $$_JOB 6 |
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156 | 156 | | •HR 2636 IH |
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157 | 157 | | deeming each reference in such section to 1 |
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158 | 158 | | ‘individual health insurance coverage’ to be 2 |
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159 | 159 | | a reference to a plan described in para-3 |
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160 | 160 | | graph (1).’’. 4 |
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161 | 161 | | (d) ERISA.— 5 |
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162 | 162 | | (1) I |
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163 | 163 | | N GENERAL.—Subpart B of part 7 of sub-6 |
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164 | 164 | | title B of title I of the Employee Retirement Income 7 |
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165 | 165 | | Security Act of 1974 (29 U.S.C. 1185 et seq.) is 8 |
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166 | 166 | | amended by adding at the end the following: 9 |
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167 | 167 | | ‘‘SEC. 726. REQUIREMENTS WITH RESPECT TO COST-SHAR-10 |
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168 | 168 | | ING FOR CERTAIN INSULIN PRODUCTS. 11 |
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169 | 169 | | ‘‘(a) I |
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170 | 170 | | NGENERAL.—For plan years beginning on or 12 |
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171 | 171 | | after January 1, 2026, a group health plan or health in-13 |
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172 | 172 | | surance issuer offering group health insurance coverage 14 |
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173 | 173 | | shall, with respect to enrolled individuals 26 years of age 15 |
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174 | 174 | | or younger, provide coverage of selected insulin products, 16 |
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175 | 175 | | and with respect to such products, shall not— 17 |
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176 | 176 | | ‘‘(1) apply any deductible; or 18 |
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177 | 177 | | ‘‘(2) impose any cost-sharing in excess of the 19 |
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178 | 178 | | lesser of, per 30-day supply— 20 |
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179 | 179 | | ‘‘(A) $35; or 21 |
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180 | 180 | | ‘‘(B) the amount equal to 25 percent of 22 |
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181 | 181 | | the negotiated price of the selected insulin prod-23 |
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182 | 182 | | uct net of all price concessions received by or on 24 |
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183 | 183 | | behalf of the plan or coverage, including price 25 |
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184 | 184 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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185 | 185 | | mprince on LAP1J3WLY3PROD with $$_JOB 7 |
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186 | 186 | | •HR 2636 IH |
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187 | 187 | | concessions received by or on behalf of third- 1 |
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188 | 188 | | party entities providing services to the plan or 2 |
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189 | 189 | | coverage, such as pharmacy benefit manage-3 |
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190 | 190 | | ment services. 4 |
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191 | 191 | | ‘‘(b) D |
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192 | 192 | | EFINITIONS.—In this section: 5 |
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193 | 193 | | ‘‘(1) S |
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194 | 194 | | ELECTED INSULIN PRODUCTS .—The term 6 |
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195 | 195 | | ‘selected insulin products’ means at least one of each 7 |
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196 | 196 | | dosage form (such as vial, pump, or inhaler dosage 8 |
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197 | 197 | | forms) of each different type (such as rapid-acting, 9 |
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198 | 198 | | short-acting, intermediate-acting, long-acting, ultra 10 |
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199 | 199 | | long-acting, and premixed) of insulin (as defined 11 |
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200 | 200 | | below), when available, as selected by the group 12 |
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201 | 201 | | health plan or health insurance issuer. 13 |
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202 | 202 | | ‘‘(2) I |
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203 | 203 | | NSULIN DEFINED.—The term ‘insulin’ 14 |
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204 | 204 | | means insulin that is licensed under subsection (a) 15 |
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205 | 205 | | or (k) of section 351 of the Public Health Service 16 |
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206 | 206 | | Act (42 U.S.C. 262) and continues to be marketed 17 |
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207 | 207 | | under such section, including any insulin product 18 |
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208 | 208 | | that has been deemed to be licensed under section 19 |
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209 | 209 | | 351(a) of such Act pursuant to section 7002(e)(4) 20 |
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210 | 210 | | of the Biologics Price Competition and Innovation 21 |
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211 | 211 | | Act of 2009 (Public Law 111–148) and continues to 22 |
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212 | 212 | | be marketed pursuant to such licensure. 23 |
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213 | 213 | | ‘‘(c) R |
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214 | 214 | | ULE OFCONSTRUCTION.—Subsection (a) shall 24 |
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215 | 215 | | not be construed to require coverage of, or prevent a group 25 |
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216 | 216 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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217 | 217 | | mprince on LAP1J3WLY3PROD with $$_JOB 8 |
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218 | 218 | | •HR 2636 IH |
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219 | 219 | | health plan or health insurance coverage from imposing 1 |
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220 | 220 | | cost-sharing other than the levels specified in subsection 2 |
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221 | 221 | | (a) on, insulin products that are not selected insulin prod-3 |
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222 | 222 | | ucts or insulin products for an individual not described 4 |
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223 | 223 | | in subsection (a), to the extent that such coverage is not 5 |
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224 | 224 | | otherwise required and such cost-sharing is otherwise per-6 |
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225 | 225 | | mitted under Federal and applicable State law. 7 |
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226 | 226 | | ‘‘(d) A |
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227 | 227 | | PPLICATION OF COST-SHARINGTOWARDS 8 |
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228 | 228 | | D |
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229 | 229 | | EDUCTIBLES AND OUT-OF-POCKETMAXIMUMS.—Any 9 |
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230 | 230 | | cost-sharing payments made pursuant to subsection (a)(2) 10 |
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231 | 231 | | shall be counted toward any deductible or out-of-pocket 11 |
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232 | 232 | | maximum that applies under the plan or coverage.’’. 12 |
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233 | 233 | | (2) C |
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234 | 234 | | LERICAL AMENDMENT .—The table of con-13 |
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235 | 235 | | tents in section 1 of the Employee Retirement In-14 |
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236 | 236 | | come Security Act of 1974 (29 U.S.C. 1001 et seq.) 15 |
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237 | 237 | | is amended by inserting after the item relating to 16 |
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238 | 238 | | section 725 the following: 17 |
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239 | 239 | | ‘‘Sec. 726. Requirements with respect to cost-sharing for certain insulin prod- |
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240 | 240 | | ucts.’’. |
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241 | 241 | | (e) INTERNALREVENUECODE.— 18 |
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242 | 242 | | (1) I |
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243 | 243 | | N GENERAL.—Subchapter B of chapter 19 |
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244 | 244 | | 100 of the Internal Revenue Code of 1986 is amend-20 |
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245 | 245 | | ed by adding at the end the following new section: 21 |
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246 | 246 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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247 | 247 | | mprince on LAP1J3WLY3PROD with $$_JOB 9 |
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248 | 248 | | •HR 2636 IH |
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249 | 249 | | ‘‘SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHAR-1 |
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250 | 250 | | ING FOR CERTAIN INSULIN PRODUCTS. 2 |
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251 | 251 | | ‘‘(a) I |
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252 | 252 | | NGENERAL.—For plan years beginning on or 3 |
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253 | 253 | | after January 1, 2026, a group health plan shall, with re-4 |
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254 | 254 | | spect to enrolled individuals 26 years of age or younger, 5 |
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255 | 255 | | provide coverage of selected insulin products, and with re-6 |
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256 | 256 | | spect to such products, shall not— 7 |
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257 | 257 | | ‘‘(1) apply any deductible; or 8 |
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258 | 258 | | ‘‘(2) impose any cost-sharing in excess of the 9 |
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259 | 259 | | lesser of, per 30-day supply— 10 |
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260 | 260 | | ‘‘(A) $35; or 11 |
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261 | 261 | | ‘‘(B) the amount equal to 25 percent of 12 |
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262 | 262 | | the negotiated price of the selected insulin prod-13 |
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263 | 263 | | uct net of all price concessions received by or on 14 |
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264 | 264 | | behalf of the plan, including price concessions 15 |
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265 | 265 | | received by or on behalf of third-party entities 16 |
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266 | 266 | | providing services to the plan, such as phar-17 |
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267 | 267 | | macy benefit management services. 18 |
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268 | 268 | | ‘‘(b) D |
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269 | 269 | | EFINITIONS.—In this section: 19 |
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270 | 270 | | ‘‘(1) S |
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271 | 271 | | ELECTED INSULIN PRODUCTS .—The term 20 |
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272 | 272 | | ‘selected insulin products’ means at least one of each 21 |
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273 | 273 | | dosage form (such as vial, pump, or inhaler dosage 22 |
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274 | 274 | | forms) of each different type (such as rapid-acting, 23 |
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275 | 275 | | short-acting, intermediate-acting, long-acting, ultra 24 |
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276 | 276 | | long-acting, and premixed) of insulin (as defined 25 |
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277 | 277 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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278 | 278 | | mprince on LAP1J3WLY3PROD with $$_JOB 10 |
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279 | 279 | | •HR 2636 IH |
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280 | 280 | | below), when available, as selected by the group 1 |
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281 | 281 | | health plan. 2 |
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282 | 282 | | ‘‘(2) I |
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283 | 283 | | NSULIN DEFINED.—The term ‘insulin’ 3 |
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284 | 284 | | means insulin that is licensed under subsection (a) 4 |
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285 | 285 | | or (k) of section 351 of the Public Health Service 5 |
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286 | 286 | | Act (42 U.S.C. 262) and continues to be marketed 6 |
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287 | 287 | | under such section, including any insulin product 7 |
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288 | 288 | | that has been deemed to be licensed under section 8 |
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289 | 289 | | 351(a) of such Act pursuant to section 7002(e)(4) 9 |
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290 | 290 | | of the Biologics Price Competition and Innovation 10 |
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291 | 291 | | Act of 2009 (Public Law 111–148) and continues to 11 |
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292 | 292 | | be marketed pursuant to such licensure. 12 |
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293 | 293 | | ‘‘(c) R |
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294 | 294 | | ULE OFCONSTRUCTION.—Subsection (a) shall 13 |
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295 | 295 | | not be construed to require coverage of, or prevent a group 14 |
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296 | 296 | | health plan from imposing cost-sharing other than the lev-15 |
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297 | 297 | | els specified in subsection (a) on, insulin products that are 16 |
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298 | 298 | | not selected insulin products or insulin products for an 17 |
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299 | 299 | | individual not described in subsection (a), to the extent 18 |
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300 | 300 | | that such coverage is not otherwise required and such 19 |
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301 | 301 | | cost-sharing is otherwise permitted under Federal and ap-20 |
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302 | 302 | | plicable State law. 21 |
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303 | 303 | | ‘‘(d) A |
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304 | 304 | | PPLICATION OF COST-SHARINGTOWARDS 22 |
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305 | 305 | | D |
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306 | 306 | | EDUCTIBLES AND OUT-OF-POCKETMAXIMUMS.—Any 23 |
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307 | 307 | | cost-sharing payments made pursuant to subsection (a)(2) 24 |
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308 | 308 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2636.IH H2636 |
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309 | 309 | | mprince on LAP1J3WLY3PROD with $$_JOB 11 |
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310 | 310 | | •HR 2636 IH |
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311 | 311 | | shall be counted toward any deductible or out-of-pocket 1 |
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312 | 312 | | maximum that applies under the plan.’’. 2 |
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313 | 313 | | (2) C |
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314 | 314 | | LERICAL AMENDMENT .—The table of sec-3 |
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315 | 315 | | tions for subchapter B of chapter 100 of such Code 4 |
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316 | 316 | | is amended by adding at the end the following new 5 |
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317 | 317 | | item: 6 |
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318 | 318 | | ‘‘Sec. 9826. Requirements with respect to cost-sharing for certain insulin prod- |
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319 | 319 | | ucts.’’. |
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320 | 320 | | (f) IMPLEMENTATION.—The Secretary of Health and 7 |
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321 | 321 | | Human Services, the Secretary of Labor, and the Sec-8 |
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322 | 322 | | retary of the Treasury may implement the provisions of, 9 |
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323 | 323 | | including the amendments made by, this subsection 10 |
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324 | 324 | | through sub-regulatory guidance, program instruction or 11 |
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325 | 325 | | otherwise. 12 |
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326 | 326 | | Æ |
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327 | 327 | | VerDate Sep 11 2014 08:47 Apr 09, 2025 Jkt 000000 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\H2636.IH H2636 |
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328 | 328 | | mprince on LAP1J3WLY3PROD with $$_JOB |
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