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. 1931 |
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5 | 5 | | To amend title XVIII of the Social Security Act to facilitate patient access |
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6 | 6 | | to certain pediatric technologies. |
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7 | 7 | | IN THE HOUSE OF REPRESENTATIVES |
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8 | 8 | | MARCH6, 2025 |
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9 | 9 | | Mr. J |
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10 | 10 | | OYCEof Pennsylvania (for himself and Mrs. TRAHAN) introduced the fol- |
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11 | 11 | | lowing bill; which was referred to the Committee on Energy and Com- |
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12 | 12 | | merce, and in addition to the Committee on Ways and Means, for a pe- |
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13 | 13 | | riod to be subsequently determined by the Speaker, in each case for con- |
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14 | 14 | | sideration of such provisions as fall within the jurisdiction of the com- |
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15 | 15 | | mittee concerned |
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16 | 16 | | A BILL |
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17 | 17 | | To amend title XVIII of the Social Security Act to facilitate |
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18 | 18 | | patient access to certain pediatric technologies. |
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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 ‘‘Access to Pediatric 4 |
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23 | 23 | | Technologies Act of 2025’’. 5 |
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25 | 25 | | ssavage on LAPJG3WLY3PROD with BILLS 2 |
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26 | 26 | | •HR 1931 IH |
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27 | 27 | | SEC. 2. FACILITATING ACCESS TO PEDIATRIC TECH-1 |
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28 | 28 | | NOLOGIES. 2 |
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29 | 29 | | (a) I |
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30 | 30 | | NGENERAL.—Section 1848 of the Social Secu-3 |
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31 | 31 | | rity Act (42 U.S.C. 1395w–4) is amended by adding at 4 |
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32 | 32 | | the end the following new subsection: 5 |
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33 | 33 | | ‘‘(u) F |
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34 | 34 | | ACILITATINGACCESS TOPEDIATRICTECH-6 |
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35 | 35 | | NOLOGIES.— 7 |
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36 | 36 | | ‘‘(1) I |
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37 | 37 | | N GENERAL.—For each qualifying pedi-8 |
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38 | 38 | | atric technology (as defined in paragraph (4)) fur-9 |
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39 | 39 | | nished on or after January 1, 2026, the Secretary 10 |
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40 | 40 | | shall, upon receipt of a manufacturer request under 11 |
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41 | 41 | | paragraph (3), establish national relative value units 12 |
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42 | 42 | | under the physician fee schedule established under 13 |
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43 | 43 | | this section, to the extent no such national relative 14 |
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44 | 44 | | value units have been established for such qualifying 15 |
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45 | 45 | | pediatric technology under such fee schedule. 16 |
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46 | 46 | | ‘‘(2) P |
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47 | 47 | | AYMENT METHODOLOGY .—The Secretary 17 |
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48 | 48 | | shall establish national relative value units for a 18 |
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49 | 49 | | qualifying pediatric technology under this sub-19 |
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50 | 50 | | section— 20 |
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51 | 51 | | ‘‘(A) in accordance with the payment 21 |
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52 | 52 | | methodology established under this section and 22 |
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53 | 53 | | applicable regulations; and 23 |
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54 | 54 | | ‘‘(B) using available data related to the 24 |
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55 | 55 | | qualifying pediatric technology, which may in-25 |
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56 | 56 | | clude applicable contractor pricing information, 26 |
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58 | 58 | | ssavage on LAPJG3WLY3PROD with BILLS 3 |
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59 | 59 | | •HR 1931 IH |
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60 | 60 | | claims data, time and motion studies, invoice 1 |
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61 | 61 | | information, or other information used by the 2 |
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62 | 62 | | Secretary in establishing payment rates. 3 |
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63 | 63 | | ‘‘(3) I |
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64 | 64 | | MPLEMENTATION.— 4 |
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65 | 65 | | ‘‘(A) I |
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66 | 66 | | N GENERAL.—Upon written request 5 |
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67 | 67 | | to the Secretary from the manufacturer of a 6 |
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68 | 68 | | qualifying pediatric technology, the Secretary 7 |
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69 | 69 | | shall establish national relative value units 8 |
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70 | 70 | | under paragraph (1) through the annual rule-9 |
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71 | 71 | | making process for the physician fee schedule 10 |
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72 | 72 | | established under this section, in accordance 11 |
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73 | 73 | | with the timeline described in subparagraph 12 |
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74 | 74 | | (B). 13 |
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75 | 75 | | ‘‘(B) T |
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76 | 76 | | IMELINE.— 14 |
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77 | 77 | | ‘‘(i) In the case where the Secretary 15 |
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78 | 78 | | receives a request under this paragraph on 16 |
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79 | 79 | | or before May 1 of a given year from a 17 |
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80 | 80 | | manufacturer with respect to a qualifying 18 |
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81 | 81 | | pediatric technology of the manufacturer, 19 |
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82 | 82 | | the Secretary shall establish national rel-20 |
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83 | 83 | | ative value units for the qualifying pedi-21 |
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84 | 84 | | atric technology in the rulemaking process 22 |
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85 | 85 | | during that year for the physician fee 23 |
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86 | 86 | | schedule established under this section. 24 |
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88 | 88 | | ssavage on LAPJG3WLY3PROD with BILLS 4 |
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89 | 89 | | •HR 1931 IH |
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90 | 90 | | ‘‘(ii) In the case where the Secretary 1 |
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91 | 91 | | receives a request under this paragraph 2 |
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92 | 92 | | after May 1 of a given year from a manu-3 |
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93 | 93 | | facturer with respect to a qualifying pedi-4 |
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94 | 94 | | atric technology of the manufacturer, the 5 |
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95 | 95 | | Secretary shall establish national relative 6 |
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96 | 96 | | value units for the qualifying pediatric 7 |
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97 | 97 | | technology in the rulemaking process dur-8 |
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98 | 98 | | ing the following year for the physician fee 9 |
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99 | 99 | | schedule established under this section. 10 |
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100 | 100 | | ‘‘(C) C |
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101 | 101 | | ONTENT OF MANUFACTURER RE -11 |
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102 | 102 | | QUESTS.—A manufacturer submitting a request 12 |
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103 | 103 | | under paragraph with respect to a qualifying 13 |
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104 | 104 | | pediatric technology of the manufacturer shall 14 |
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105 | 105 | | include in such request information to verify 15 |
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106 | 106 | | that the technology is a qualifying pediatric 16 |
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107 | 107 | | technology and to allow the Secretary to estab-17 |
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108 | 108 | | lish national relative value units for such tech-18 |
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109 | 109 | | nology, including (to the extent available) con-19 |
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110 | 110 | | tractor pricing information, claims data, time 20 |
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111 | 111 | | and motion studies, invoice information, or 21 |
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112 | 112 | | other relevant information. 22 |
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113 | 113 | | ‘‘(4) Q |
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114 | 114 | | UALIFYING PEDIATRIC TECHNOLOGY DE -23 |
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115 | 115 | | FINED.—In this subsection, the term ‘qualifying pe-24 |
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116 | 116 | | diatric technology’ means a medical device that is— 25 |
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118 | 118 | | ssavage on LAPJG3WLY3PROD with BILLS 5 |
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119 | 119 | | •HR 1931 IH |
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120 | 120 | | ‘‘(A) covered under this title; 1 |
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121 | 121 | | ‘‘(B) approved, cleared, or authorized 2 |
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122 | 122 | | under section 510(k), 513(f)(2), or 515 of the 3 |
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123 | 123 | | Federal Food, Drug, and Cosmetic Act (21 4 |
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124 | 124 | | U.S.C. 360(k), 360c(f)(2), 360e); 5 |
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125 | 125 | | ‘‘(C) described by a temporary Level I 6 |
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126 | 126 | | HCPCS Code intended for emerging tech-7 |
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127 | 127 | | nologies, services, or procedures; and 8 |
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128 | 128 | | ‘‘(D)(i) used as part of a procedure pre-9 |
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129 | 129 | | dominantly performed on pediatric patients; or 10 |
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130 | 130 | | ‘‘(ii) has otherwise been specifically de-11 |
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131 | 131 | | signed for safe and effective use in pediatric 12 |
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132 | 132 | | populations. 13 |
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133 | 133 | | ‘‘(5) R |
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134 | 134 | | ULE OF CONSTRUCTION .—Nothing in 14 |
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135 | 135 | | this subsection shall be construed to require cov-15 |
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136 | 136 | | erage of a qualifying pediatric technology under this 16 |
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137 | 137 | | title or alter the requirements of section 17 |
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138 | 138 | | 1862(a)(1)(A).’’. 18 |
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139 | 139 | | Æ |
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141 | 141 | | ssavage on LAPJG3WLY3PROD with BILLS |
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