Second Regular Session Seventy-fourth General Assembly STATE OF COLORADO REREVISED This Version Includes All Amendments Adopted in the Second House LLS NO. 24-0481.01 Brita Darling x2241 SENATE BILL 24-124 Senate Committees House Committees Health & Human Services Health & Human Services Appropriations A BILL FOR AN ACT C ONCERNING REQUIRING HEALTH -CARE COVERAGE FOR BIOMARKER101 TESTING.102 Bill Summary (Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov .) The bill requires all individual and group health benefit plans to provide coverage for biomarker testing to guide treatment decisions if the testing is supported by medical and scientific evidence. The bill defines "biomarker testing" as an analysis of a patient's tissue, blood, or other biospecimen for the presence of an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific HOUSE 3rd Reading Unamended May 5, 2024 HOUSE Amended 2nd Reading May 4, 2024 SENATE 3rd Reading Unamended April 26, 2024 SENATE Amended 2nd Reading April 25, 2024 SENATE SPONSORSHIP Michaelson Jenet and Rich, Buckner, Cutter, Exum, Fenberg, Ginal, Gonzales, Hansen, Hinrichsen, Kirkmeyer, Kolker, Marchman, Mullica, Pelton B., Pelton R., Priola, Roberts, Will, Winter F. HOUSE SPONSORSHIP Hartsook and Duran, Bird, Boesenecker, Brown, English, Hamrick, Jodeh, Kipp, Lieder, Lindsay, Lukens, McCluskie, McCormick, McLachlan, Rutinel, Titone Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment. Capital letters or bold & italic numbers indicate new material to be added to existing law. Dashes through the words or numbers indicate deletions from existing law. therapeutic intervention. The required testing under the bill does not include biomarker testing for screening purposes or direct-to-consumer genetic tests. The bill requires the commissioner of insurance to implement biomarker testing coverage for all individual and group health benefit plans issued or renewed on or after January 1, 2026. Biomarker testing is subject to the health benefit plan's annual deductibles, copayment, or coinsurance but is not subject to any annual or lifetime maximum benefit limit. Subject to federal authorization and federal financial participation, beginning July 1, 2025, the bill includes coverage for biomarker testing as part of the state medical assistance program to guide treatment decisions if the testing is supported by medical and scientific evidence. The bill requires the medical assistance program to have a clear, easily accessible appeals process if biomarker testing is denied. Be it enacted by the General Assembly of the State of Colorado:1 SECTION 1. In Colorado Revised Statutes, 10-16-104, add (27)2 as follows:3 10-16-104. Mandatory coverage provisions - definitions -4 rules. (27) Biomarker testing. (a) A LL LARGE GROUP HEALTH BENEFIT 5 PLANS AND, TO THE EXTENT THAT SUCH COVERAGE IS NOT IN ADDITION TO6 THE BENEFITS PROVIDED PURSUANT TO THE BENCHMARK PLAN , ALL7 INDIVIDUAL AND SMALL GROUP HEALTH BENEFIT PLANS SHALL PROVIDE8 COVERAGE FOR BIOMARKER TESTING PURSUANT TO THIS SUBSECTION (27).9 (b) C OVERAGE MUST INCLUDE BIOMARKER TESTING FOR10 DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT , AND ONGOING11 MONITORING OF A COVERED PERSON 'S DISEASE OR CONDITION TO GUIDE12 TREATMENT DECISIONS WHEN THE TEST IS SUPPORTED BY MEDICAL AND13 SCIENTIFIC EVIDENCE, INCLUDING:14 (I) L ABELED INDICATIONS FOR AN FDA-APPROVED OR15 FDA- CLEARED TEST;16 (II) I NDICATED TESTS FOR AN FDA-APPROVED DRUG;17 124-2- (III) WARNINGS AND PRECAUTIONS ON FDA-APPROVED DRUG1 LABELS;2 (IV) C ENTERS FOR MEDICARE AND MEDICAID SERVICES NATIONAL3 COVERAGE DETERMINATIONS OR MEDICARE ADMINISTRATIVE4 CONTRACTOR LOCAL COVERAGE DETERMINATIONS ; OR5 (V) N ATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES , 6 CONSENSUS STATEMENTS , AND PEER-REVIEWED STUDIES.7 (c) T HE COVERAGE REQUIRED BY THIS SUBSECTION (27) IS SUBJECT8 TO ANNUAL DEDUCTIBLES , COPAYMENTS , OR COINSURANCE9 REQUIREMENTS UNDER THE HEALTH BENEFIT PLAN BUT IS NOT SUBJECT TO10 ANY ANNUAL OR LIFETIME MAXIMUM BENEFIT LIMIT .11 (d) T HE COVERAGE REQUIRED BY THIS SUBSECTION (27) MUST BE12 PROVIDED IN A MANNER THAT LIMITS UNREASONABLE DISRUPTIONS IN13 CARE, INCLUDING LIMITING THE NEED FOR MULTIPLE BIOPSIES OR14 BIOSPECIMEN SAMPLES.15 (e) N OTHING IN THIS SUBSECTION (27) SHALL BE CONSTRUED TO16 REQUIRE COVERAGE FOR BIOMARKER TESTING FOR SCREENING PURPOSES .17 (f) A CARRIER MAY REQUIRE PRIOR AUTHORIZATION FOR18 BIOMARKER TESTING IN THE SAME MANNER THAT PRIOR AUTHORIZATION19 IS REQUIRED FOR ANY OTHER COVERED BENEFIT AND CONSISTENT WITH20 SECTION 10-16-112.5.21 (g) (I) W ITHIN ONE HUNDRED TWENTY DAYS AFTER THE EFFECTIVE 22 DATE OF THIS SECTION, THE DIVISION SHALL SUBMIT TO THE FEDERAL23 DEPARTMENT OF HEALTH AND HUMAN SERVICES :24 (A) A DETERMINATION AS TO WHETHER THE BENEFIT SPECIFIED IN 25 THIS SUBSECTION (27) IS IN ADDITION TO ESSENTIAL HEALTH BENEFITS AND26 WOULD BE SUBJECT TO DEFRAYAL BY THE STATE PURSUANT TO 42 U.S.C.27 124 -3- SEC. 18031 (d)(3)(B); AND1 (B) A REQUEST THAT THE FEDERAL DEPARTMENT OF HEALTH AND 2 HUMAN SERVICES CONFIRM THE DIVISION'S DETERMINATION WITHIN SIXTY3 DAYS AFTER RECEIPT OF THE DIVISION'S REQUEST AND SUBMISSION OF ITS4 DETERMINATION.5 (II) T HIS SUBSECTION (27) APPLIES TO, AND THE DIVISION SHALL 6 IMPLEMENT THE PROVISIONS OF THIS SUBSECTION (27) FOR, LARGE7 EMPLOYER HEALTH BENEFIT PLANS ISSUED OR RENEWED IN THIS STATE ON8 OR AFTER JANUARY 1, 2025.9 (III) T HIS SUBSECTION (27) APPLIES TO, AND THE DIVISION SHALL 10 IMPLEMENT THE REQUIREMENTS OF THIS SUBSECTION (27) FOR,11 INDIVIDUAL AND SMALL GROUP HEALTH BENEFIT PLANS ISSUED OR12 RENEWED IN THIS STATE TWELVE MONTHS AFTER THE EARLIER OF THE13 FOLLOWING:14 (A) T HE DIVISION RECEIVES CONFIRMATION FROM THE FEDERAL 15 DEPARTMENT OF HEALTH AND HUMAN SERVICES THAT THE COVERAGE16 SPECIFIED IN THIS SUBSECTION (27) DOES NOT CONSTITUTE AN ADDITIONAL17 BENEFIT THAT REQUIRES DEFRAYAL BY THE STATE PURSUANT TO 42 U.S.C.18 SEC. 18031 (d)(3)(B);19 (B) T HE FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES 20 HAS OTHERWISE INFORMED THE DIVISION THAT THE COVERAGE DOES NOT21 REQUIRE STATE DEFRAYAL PURSUANT TO 42 U.S.C. SEC. 18031 (d)(3)(B);22 OR23 (C) M ORE THAN THREE HUNDRED SIXTY -FIVE DAYS HAVE PASSED 24 SINCE THE DIVISION SUBMITTED ITS DETERMINATION AND REQUEST FOR25 CONFIRMATION THAT THE COVERAGE SPECIFIED IN THIS SUBSECTION (27)26 IS NOT AN ADDITIONAL BENEFIT THAT REQUIRES STATE DEFRAYAL27 124 -4- PURSUANT TO 42 U.S.C. SEC. 18031 (d)(3)(B), AND THE FEDERAL1 DEPARTMENT OF HEALTH AND HUMAN SERVICES HAS FAILED TO RESPOND2 TO THE REQUEST WITHIN THAT PERIOD , IN WHICH CASE THE DIVISION3 SHALL CONSIDER THE FEDERAL DEPARTMENT OF HEALTH AND HUMAN4 SERVICES' UNREASONABLE DELAY A PRECLUSION FROM REQUIRING5 DEFRAYAL BY THE STATE.6 (h) THE COMMISSIONER SHALL IMPLEMENT THIS SUBSECTION (27)7 AND SHALL ADOPT RULES CONSISTENT WITH AND AS ARE NECESSARY TO8 IMPLEMENT THIS SUBSECTION (27).9 (i) AS USED IN THIS SUBSECTION (27):10 (I) "B IOMARKER" MEANS A CHARACTERISTIC THAT IS OBJECTIVELY11 MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL12 PROCESSES, PATHOGENIC PROCESSES, OR PHARMACOLOGIC RESPONSES TO13 A SPECIFIC THERAPEUTIC INTERVENTION, INCLUDING KNOWN GENE-DRUG14 INTERACTIONS FOR MEDICATIONS BEING CONSIDERED FOR USE OR15 ALREADY BEING ADMINISTERED . "BIOMARKER" INCLUDES GENE16 MUTATIONS, CHARACTERISTICS OF GENES, OR PROTEIN EXPRESSION.17 (II) "B IOMARKER TESTING" MEANS THE ANALYSIS OF A PATIENT'S18 TISSUE, BLOOD, OR OTHER BIOSPECIMEN FOR THE PRESENCE OF A19 BIOMARKER. "BIOMARKER TESTING" INCLUDES SINGLE-ANALYTE TESTS,20 MULTIPLEX PANEL TESTS, PROTEIN EXPRESSION, AND WHOLE EXOME ,21 WHOLE GENOME, AND WHOLE TRANSCRIPTOME SEQUENCING . "BIOMARKER22 TESTING" DOES NOT INCLUDE DIRECT-TO-CONSUMER GENETIC TESTS.23 (III) "C ONSENSUS STATEMENTS" MEANS STATEMENTS DEVELOPED24 BY AN INDEPENDENT, MULTIDISCIPLINARY PANEL OF EXPERTS UTILIZING25 A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE AND WITH26 A CONFLICT OF INTEREST POLICY . CONSENSUS STATEMENTS ARE27 124 -5- DEVELOPED FOR SPECIFIC CLINICAL CIRCUMSTANCES AND ARE BASED ON1 THE BEST AVAILABLE EVIDENCE FOR THE PURPOSE OF OPTIMIZING THE2 OUTCOMES OF CLINICAL CARE.3 (IV) "N ATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES "4 MEANS EVIDENCE-BASED CLINICAL PRACTICE GUIDELINES DEVELOPED BY5 INDEPENDENT ORGANIZATIONS OR MEDICAL PROFESSIONAL SOCIETIES6 UTILIZING A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE7 AND WITH A CONFLICT OF INTEREST POLICY . CLINICAL PRACTICE8 GUIDELINES:9 (A) E STABLISH STANDARDS OF CARE INFORMED BY A SYSTEMATIC10 REVIEW OF EVIDENCE AND AN ASSESSMENT OF THE BENEFITS AND RISKS OF11 ALTERNATIVE CARE OPTIONS; AND12 (B) I NCLUDE RECOMMENDATIONS INTENDED TO OPTIMIZE PATIENT13 CARE.14 15 SECTION 2. Safety clause. The general assembly finds,16 determines, and declares that this act is necessary for the immediate17 preservation of the public peace, health, or safety or for appropriations for18 the support and maintenance of the departments of the state and state19 institutions.20 124 -6-