2 | | - | BY SENATOR(S) Michaelson Jenet and Rich, Buckner, Cutter, Exum, |
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3 | | - | Ginal, Gonzales, Hansen, Hinrichsen, Kirkmeyer, Kolker, Marchman, |
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4 | | - | Mullica, Pelton B., Pelton R., Priola, Roberts, Will, Winter F., Fenberg; |
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5 | | - | also REPRESENTATIVE(S) Hartsook and Duran, Bird, Boesenecker, |
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6 | | - | Brown, English, Hamrick, Jodeh, Kipp, Lieder, Lindsay, Lukens, |
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7 | | - | McCormick, McLachlan, Rutinel, Titone, McCluskie. |
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| 9 | + | Senate Committees House Committees |
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| 10 | + | Health & Human Services Health & Human Services |
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| 11 | + | Appropriations |
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| 12 | + | A BILL FOR AN ACT |
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9 | | - | ONCERNING REQUIRING HEALTH -CARE COVERAGE FOR BIOMARKER |
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10 | | - | TESTING |
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11 | | - | . |
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12 | | - | |
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13 | | - | Be it enacted by the General Assembly of the State of Colorado: |
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14 | | - | SECTION 1. In Colorado Revised Statutes, 10-16-104, add (28) as |
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15 | | - | follows: |
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16 | | - | 10-16-104. Mandatory coverage provisions - definitions - rules. |
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17 | | - | (28) Biomarker testing. (a) A |
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18 | | - | LL LARGE GROUP HEALTH BENEFIT PLANS |
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19 | | - | AND |
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20 | | - | , TO THE EXTENT THAT SUCH COVERAGE IS NOT IN ADDITION TO THE |
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21 | | - | BENEFITS PROVIDED PURSUANT TO THE BENCHMARK PLAN |
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22 | | - | , ALL INDIVIDUAL |
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23 | | - | AND SMALL GROUP HEALTH BENEFIT PLANS SHALL PROVIDE COVERAGE FOR |
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24 | | - | BIOMARKER TESTING PURSUANT TO THIS SUBSECTION |
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25 | | - | (28). |
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26 | | - | NOTE: This bill has been prepared for the signatures of the appropriate legislative |
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27 | | - | officers and the Governor. To determine whether the Governor has signed the bill |
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28 | | - | or taken other action on it, please consult the legislative status sheet, the legislative |
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29 | | - | history, or the Session Laws. |
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30 | | - | ________ |
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31 | | - | Capital letters or bold & italic numbers indicate new material added to existing law; dashes |
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32 | | - | through words or numbers indicate deletions from existing law and such material is not part of |
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33 | | - | the act. (b) COVERAGE MUST INCLUDE BIOMARKER TESTING FOR DIAGNOSIS , |
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34 | | - | TREATMENT, APPROPRIATE MANAGEMENT , AND ONGOING MONITORING OF A |
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35 | | - | COVERED PERSON |
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36 | | - | 'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS |
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37 | | - | WHEN THE TEST IS SUPPORTED BY MEDICAL AND SCIENTIFIC EVIDENCE |
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38 | | - | , |
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39 | | - | INCLUDING: |
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| 14 | + | ONCERNING REQUIRING HEALTH -CARE COVERAGE FOR BIOMARKER101 |
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| 15 | + | TESTING.102 |
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| 16 | + | Bill Summary |
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| 17 | + | (Note: This summary applies to this bill as introduced and does |
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| 18 | + | not reflect any amendments that may be subsequently adopted. If this bill |
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| 19 | + | passes third reading in the house of introduction, a bill summary that |
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| 20 | + | applies to the reengrossed version of this bill will be available at |
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| 21 | + | http://leg.colorado.gov |
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| 22 | + | .) |
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| 23 | + | The bill requires all individual and group health benefit plans to |
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| 24 | + | provide coverage for biomarker testing to guide treatment decisions if the |
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| 25 | + | testing is supported by medical and scientific evidence. The bill defines |
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| 26 | + | "biomarker testing" as an analysis of a patient's tissue, blood, or other |
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| 27 | + | biospecimen for the presence of an indicator of normal biological |
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| 28 | + | processes, pathogenic processes, or pharmacologic responses to a specific |
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| 29 | + | HOUSE |
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| 30 | + | 3rd Reading Unamended |
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| 31 | + | May 5, 2024 |
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| 32 | + | HOUSE |
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| 33 | + | Amended 2nd Reading |
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| 34 | + | May 4, 2024 |
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| 35 | + | SENATE |
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| 36 | + | 3rd Reading Unamended |
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| 37 | + | April 26, 2024 |
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| 38 | + | SENATE |
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| 39 | + | Amended 2nd Reading |
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| 40 | + | April 25, 2024 |
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| 41 | + | SENATE SPONSORSHIP |
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| 42 | + | Michaelson Jenet and Rich, Buckner, Cutter, Exum, Fenberg, Ginal, Gonzales, Hansen, |
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| 43 | + | Hinrichsen, Kirkmeyer, Kolker, Marchman, Mullica, Pelton B., Pelton R., Priola, Roberts, |
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| 44 | + | Will, Winter F. |
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| 45 | + | HOUSE SPONSORSHIP |
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| 46 | + | Hartsook and Duran, Bird, Boesenecker, Brown, English, Hamrick, Jodeh, Kipp, Lieder, |
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| 47 | + | Lindsay, Lukens, McCluskie, McCormick, McLachlan, Rutinel, Titone |
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| 48 | + | Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. |
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| 49 | + | Capital letters or bold & italic numbers indicate new material to be added to existing law. |
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| 50 | + | Dashes through the words or numbers indicate deletions from existing law. therapeutic intervention. The required testing under the bill does not |
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| 51 | + | include biomarker testing for screening purposes or direct-to-consumer |
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| 52 | + | genetic tests. |
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| 53 | + | The bill requires the commissioner of insurance to implement |
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| 54 | + | biomarker testing coverage for all individual and group health benefit |
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| 55 | + | plans issued or renewed on or after January 1, 2026. |
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| 56 | + | Biomarker testing is subject to the health benefit plan's annual |
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| 57 | + | deductibles, copayment, or coinsurance but is not subject to any annual |
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| 58 | + | or lifetime maximum benefit limit. |
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| 59 | + | Subject to federal authorization and federal financial participation, |
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| 60 | + | beginning July 1, 2025, the bill includes coverage for biomarker testing |
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| 61 | + | as part of the state medical assistance program to guide treatment |
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| 62 | + | decisions if the testing is supported by medical and scientific evidence. |
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| 63 | + | The bill requires the medical assistance program to have a clear, |
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| 64 | + | easily accessible appeals process if biomarker testing is denied. |
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| 65 | + | Be it enacted by the General Assembly of the State of Colorado:1 |
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| 66 | + | SECTION 1. In Colorado Revised Statutes, 10-16-104, add (27)2 |
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| 67 | + | as follows:3 |
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| 68 | + | 10-16-104. Mandatory coverage provisions - definitions -4 |
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| 69 | + | rules. (27) Biomarker testing. (a) A |
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| 70 | + | LL LARGE GROUP HEALTH BENEFIT |
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| 71 | + | 5 |
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| 72 | + | PLANS AND, TO THE EXTENT THAT SUCH COVERAGE IS NOT IN ADDITION TO6 |
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| 73 | + | THE BENEFITS PROVIDED PURSUANT TO THE BENCHMARK PLAN , ALL7 |
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| 74 | + | INDIVIDUAL AND SMALL GROUP HEALTH BENEFIT PLANS SHALL PROVIDE8 |
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| 75 | + | COVERAGE FOR BIOMARKER TESTING PURSUANT TO THIS SUBSECTION (27).9 |
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| 76 | + | (b) C |
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| 77 | + | OVERAGE MUST INCLUDE BIOMARKER TESTING FOR10 |
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| 78 | + | DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT , AND ONGOING11 |
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| 79 | + | MONITORING OF A COVERED PERSON 'S DISEASE OR CONDITION TO GUIDE12 |
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| 80 | + | TREATMENT DECISIONS WHEN THE TEST IS SUPPORTED BY MEDICAL AND13 |
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| 81 | + | SCIENTIFIC EVIDENCE, INCLUDING:14 |
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122 | | - | HAS OTHERWISE INFORMED THE DIVISION THAT THE COVERAGE DOES NOT |
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123 | | - | REQUIRE STATE DEFRAYAL PURSUANT TO |
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124 | | - | 42 U.S.C. SEC. 18031 (d)(3)(B); OR |
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125 | | - | (C) MORE THAN THREE HUNDRED SIXTY -FIVE DAYS HAVE PASSED |
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126 | | - | SINCE THE DIVISION SUBMITTED ITS DETERMINATION AND REQUEST FOR |
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127 | | - | CONFIRMATION THAT THE COVERAGE SPECIFIED IN THIS SUBSECTION |
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128 | | - | (28) IS |
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129 | | - | NOT AN ADDITIONAL BENEFIT THAT REQUIRES STATE DEFRAYAL PURSUANT |
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130 | | - | TO |
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131 | | - | 42 U.S.C. SEC. 18031 (d)(3)(B), AND THE FEDERAL DEPARTMENT OF |
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132 | | - | HEALTH AND HUMAN SERVICES HAS FAILED TO RESPOND TO THE REQUEST |
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133 | | - | WITHIN THAT PERIOD |
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134 | | - | , IN WHICH CASE THE DIVISION SHALL CONSIDER THE |
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135 | | - | PAGE 3-SENATE BILL 24-124 FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES ' UNREASONABLE |
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136 | | - | DELAY A PRECLUSION FROM REQUIRING DEFRAYAL BY THE STATE |
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137 | | - | . |
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138 | | - | (h) T |
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139 | | - | HE COMMISSIONER SHALL IMPLEMENT THIS SUBSECTION (28) |
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140 | | - | AND SHALL ADOPT RULES CONSISTENT WITH AND AS ARE NECESSARY TO |
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141 | | - | IMPLEMENT THIS SUBSECTION |
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142 | | - | (28). |
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143 | | - | (i) A |
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144 | | - | S USED IN THIS SUBSECTION (28): |
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| 156 | + | 20 |
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| 157 | + | HAS OTHERWISE INFORMED THE DIVISION THAT THE COVERAGE DOES NOT21 |
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| 158 | + | REQUIRE STATE DEFRAYAL PURSUANT TO 42 U.S.C. SEC. 18031 (d)(3)(B);22 |
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| 159 | + | OR23 |
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| 160 | + | (C) M |
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| 161 | + | ORE THAN THREE HUNDRED SIXTY -FIVE DAYS HAVE PASSED |
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| 162 | + | 24 |
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| 163 | + | SINCE THE DIVISION SUBMITTED ITS DETERMINATION AND REQUEST FOR25 |
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| 164 | + | CONFIRMATION THAT THE COVERAGE SPECIFIED IN THIS SUBSECTION (27)26 |
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| 165 | + | IS NOT AN ADDITIONAL BENEFIT THAT REQUIRES STATE DEFRAYAL27 |
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| 166 | + | 124 |
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| 167 | + | -4- PURSUANT TO 42 U.S.C. SEC. 18031 (d)(3)(B), AND THE FEDERAL1 |
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| 168 | + | DEPARTMENT OF HEALTH AND HUMAN SERVICES HAS FAILED TO RESPOND2 |
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| 169 | + | TO THE REQUEST WITHIN THAT PERIOD , IN WHICH CASE THE DIVISION3 |
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| 170 | + | SHALL CONSIDER THE FEDERAL DEPARTMENT OF HEALTH AND HUMAN4 |
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| 171 | + | SERVICES' UNREASONABLE DELAY A PRECLUSION FROM REQUIRING5 |
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| 172 | + | DEFRAYAL BY THE STATE.6 |
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| 173 | + | (h) THE COMMISSIONER SHALL IMPLEMENT THIS SUBSECTION (27)7 |
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| 174 | + | AND SHALL ADOPT RULES CONSISTENT WITH AND AS ARE NECESSARY TO8 |
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| 175 | + | IMPLEMENT THIS SUBSECTION (27).9 |
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| 176 | + | (i) AS USED IN THIS SUBSECTION (27):10 |
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146 | | - | IOMARKER" MEANS A CHARACTERISTIC THAT IS OBJECTIVELY |
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147 | | - | MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL |
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148 | | - | PROCESSES |
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149 | | - | , PATHOGENIC PROCESSES, OR PHARMACOLOGIC RESPONSES TO A |
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150 | | - | SPECIFIC THERAPEUTIC INTERVENTION |
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151 | | - | , INCLUDING KNOWN GENE -DRUG |
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152 | | - | INTERACTIONS FOR MEDICATIONS BEING CONSIDERED FOR USE OR ALREADY |
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153 | | - | BEING ADMINISTERED |
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154 | | - | . "BIOMARKER" INCLUDES GENE MUTATIONS , |
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155 | | - | CHARACTERISTICS OF GENES, OR PROTEIN EXPRESSION. |
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| 178 | + | IOMARKER" MEANS A CHARACTERISTIC THAT IS OBJECTIVELY11 |
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| 179 | + | MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL12 |
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| 180 | + | PROCESSES, PATHOGENIC PROCESSES, OR PHARMACOLOGIC RESPONSES TO13 |
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| 181 | + | A SPECIFIC THERAPEUTIC INTERVENTION, INCLUDING KNOWN GENE-DRUG14 |
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| 182 | + | INTERACTIONS FOR MEDICATIONS BEING CONSIDERED FOR USE OR15 |
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| 183 | + | ALREADY BEING ADMINISTERED . "BIOMARKER" INCLUDES GENE16 |
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| 184 | + | MUTATIONS, CHARACTERISTICS OF GENES, OR PROTEIN EXPRESSION.17 |
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185 | | - | STABLISH STANDARDS OF CARE INFORMED BY A SYSTEMATIC |
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186 | | - | REVIEW OF EVIDENCE AND AN ASSESSMENT OF THE BENEFITS AND RISKS OF |
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187 | | - | PAGE 4-SENATE BILL 24-124 ALTERNATIVE CARE OPTIONS; AND |
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188 | | - | (B) INCLUDE RECOMMENDATIONS INTENDED TO OPTIMIZE PATIENT |
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189 | | - | CARE |
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190 | | - | . |
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191 | | - | SECTION 2. Safety clause. The general assembly finds, |
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192 | | - | determines, and declares that this act is necessary for the immediate |
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193 | | - | preservation of the public peace, health, or safety or for appropriations for |
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194 | | - | PAGE 5-SENATE BILL 24-124 the support and maintenance of the departments of the state and state |
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195 | | - | institutions. |
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196 | | - | ____________________________ ____________________________ |
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197 | | - | Steve Fenberg |
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198 | | - | Julie McCluskie |
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199 | | - | PRESIDENT OF SPEAKER OF THE HOUSE |
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200 | | - | THE SENATE OF REPRESENTATIVES |
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201 | | - | ____________________________ ____________________________ |
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202 | | - | Cindi L. Markwell Robin Jones |
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203 | | - | SECRETARY OF CHIEF CLERK OF THE HOUSE |
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204 | | - | THE SENATE OF REPRESENTATIVES |
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205 | | - | APPROVED________________________________________ |
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206 | | - | (Date and Time) |
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207 | | - | _________________________________________ |
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208 | | - | Jared S. Polis |
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209 | | - | GOVERNOR OF THE STATE OF COLORADO |
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210 | | - | PAGE 6-SENATE BILL 24-124 |
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| 209 | + | STABLISH STANDARDS OF CARE INFORMED BY A SYSTEMATIC10 |
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| 210 | + | REVIEW OF EVIDENCE AND AN ASSESSMENT OF THE BENEFITS AND RISKS OF11 |
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| 211 | + | ALTERNATIVE CARE OPTIONS; AND12 |
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| 212 | + | (B) I |
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| 213 | + | NCLUDE RECOMMENDATIONS INTENDED TO OPTIMIZE PATIENT13 |
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| 214 | + | CARE.14 |
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| 215 | + | 15 |
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| 216 | + | SECTION 2. Safety clause. The general assembly finds,16 |
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| 217 | + | determines, and declares that this act is necessary for the immediate17 |
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| 218 | + | preservation of the public peace, health, or safety or for appropriations for18 |
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| 219 | + | the support and maintenance of the departments of the state and state19 |
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| 220 | + | institutions.20 |
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| 221 | + | 124 |
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| 222 | + | -6- |
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