Second Regular Session
Seventy-fourth General Assembly
STATE OF COLORADO
INTRODUCED
LLS NO. 24-0481.01 Brita Darling x2241
SENATE BILL 24-124
Senate Committees House Committees
Health & Human Services
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
SENATE SPONSORSHIP
Michaelson Jenet and Rich,
HOUSE SPONSORSHIP
Hartsook,
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 INDIVIDUAL AND GROUP HEALTH5
BENEFIT PLANS ISSUED OR RENEWED IN THIS STATE ON OR AFTER JANUARY6
1,
2026, SHALL PROVIDE COVERAGE FOR BIOMARKER TESTING PURSUANT7
TO THIS SUBSECTION (27).8
(b) C
OVERAGE MUST INCLUDE BIOMARKER TESTING FOR9
DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT , AND ONGOING10
MONITORING OF A COVERED PERSON 'S DISEASE OR CONDITION TO GUIDE11
TREATMENT DECISIONS WHEN THE TEST IS SUPPORTED BY MEDICAL AND12
SCIENTIFIC EVIDENCE, INCLUDING:13
(I) L
ABELED INDICATIONS FOR AN FDA-APPROVED OR14
FDA-
CLEARED TEST;15
(II) I
NDICATED TESTS FOR AN FDA-APPROVED DRUG;16
(III) W
ARNINGS AND PRECAUTIONS ON FDA-APPROVED DRUG17
SB24-124-2- LABELS;1
(IV) C
ENTERS FOR MEDICARE AND MEDICAID SERVICES NATIONAL2
COVERAGE DETERMINATIONS OR MEDICARE ADMINISTRATIVE3
CONTRACTOR LOCAL COVERAGE DETERMINATIONS ; OR4
(V) N
ATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES5
AND CONSENSUS STATEMENTS .6
(c) T
HE COVERAGE REQUIRED BY THIS SUBSECTION (27) IS SUBJECT7
TO ANNUAL DEDUCTIBLES , COPAYMENTS , OR COINSURANCE8
REQUIREMENTS UNDER THE HEALTH BENEFIT PLAN BUT IS NOT SUBJECT TO9
ANY ANNUAL OR LIFETIME MAXIMUM BENEFIT LIMIT .10
(d) T
HE COVERAGE REQUIRED BY THIS SUBSECTION (27) MUST BE11
PROVIDED IN A MANNER THAT LIMITS UNREASONABLE DISRUPTIONS IN12
CARE, INCLUDING LIMITING THE NEED FOR MULTIPLE BIOPSIES OR13
BIOSPECIMEN SAMPLES.14
(e) N
OTHING IN THIS SUBSECTION (27) SHALL BE CONSTRUED TO15
REQUIRE COVERAGE FOR BIOMARKER TESTING FOR SCREENING PURPOSES .16
(f) A
CARRIER MAY REQUIRE PRIOR AUTHORIZATION FOR17
BIOMARKER TESTING IN THE SAME MANNER THAT PRIOR AUTHORIZATION18
IS REQUIRED FOR ANY OTHER COVERED BENEFIT AND CONSISTENT WITH19
SECTION 10-16-112.5.20
(g) T
HE COMMISSIONER SHALL IMPLEMENT THIS SUBSECTION (27)21
AND SHALL ADOPT RULES CONSISTENT WITH AND AS ARE NECESSARY TO22
IMPLEMENT THIS SUBSECTION (27).23
(h) A
S USED IN THIS SUBSECTION (27):24
(I) "B
IOMARKER" MEANS A CHARACTERISTIC THAT IS OBJECTIVELY25
MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL26
PROCESSES, PATHOGENIC PROCESSES, OR PHARMACOLOGIC RESPONSES TO27
SB24-124
-3- A SPECIFIC THERAPEUTIC INTERVENTION, INCLUDING KNOWN GENE-DRUG1
INTERACTIONS FOR MEDICATIONS BEING CONSIDERED FOR USE OR2
ALREADY BEING ADMINISTERED . "BIOMARKER" INCLUDES GENE3
MUTATIONS, CHARACTERISTICS OF GENES, OR PROTEIN EXPRESSION.4
(II) "B
IOMARKER TESTING" MEANS THE ANALYSIS OF A PATIENT'S5
TISSUE, BLOOD, OR OTHER BIOSPECIMEN FOR THE PRESENCE OF A6
BIOMARKER. "BIOMARKER TESTING" INCLUDES SINGLE-ANALYTE TESTS,7
MULTIPLEX PANEL TESTS, PROTEIN EXPRESSION, AND WHOLE EXOME ,8
WHOLE GENOME, AND WHOLE TRANSCRIPTOME SEQUENCING . "BIOMARKER9
TESTING" DOES NOT INCLUDE DIRECT-TO-CONSUMER GENETIC TESTS.10
(III) "C
ONSENSUS STATEMENTS" MEANS STATEMENTS DEVELOPED11
BY AN INDEPENDENT, MULTIDISCIPLINARY PANEL OF EXPERTS UTILIZING12
A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE AND WITH13
A CONFLICT OF INTEREST POLICY . CONSENSUS STATEMENTS ARE14
DEVELOPED FOR SPECIFIC CLINICAL CIRCUMSTANCES AND ARE BASED ON15
THE BEST AVAILABLE EVIDENCE FOR THE PURPOSE OF OPTIMIZING THE16
OUTCOMES OF CLINICAL CARE.17
(IV) "N
ATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES "18
MEANS EVIDENCE-BASED CLINICAL PRACTICE GUIDELINES DEVELOPED BY19
INDEPENDENT ORGANIZATIONS OR MEDICAL PROFESSIONAL SOCIETIES20
UTILIZING A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE21
AND WITH A CONFLICT OF INTEREST POLICY . CLINICAL PRACTICE22
GUIDELINES:23
(A) E
STABLISH STANDARDS OF CARE INFORMED BY A SYSTEMATIC24
REVIEW OF EVIDENCE AND AN ASSESSMENT OF THE BENEFITS AND RISKS OF25
ALTERNATIVE CARE OPTIONS; AND26
(B) I
NCLUDE RECOMMENDATIONS INTENDED TO OPTIMIZE PATIENT27
SB24-124
-4- CARE.1
SECTION 2. In Colorado Revised Statutes, 25.5-5-202, add2
(1)(z) as follows:3
25.5-5-202. Basic services for the categorically needy - optional4
services. (1) Subject to the provisions of subsection (2) of this section,5
the following are services for which federal financial participation is6
available and that Colorado has selected to provide as optional services7
under the medical assistance program:8
(z) B
IOMARKER TESTING, AS SPECIFIED IN SECTION 25.5-5-337.9
SECTION 3. In Colorado Revised Statutes, add 25.5-5-337 as10
follows:11
25.5-5-337. Biomarker testing - federal authorization - prior12
authorization - definitions. (1) A
S USED IN THIS SECTION, UNLESS THE13
CONTEXT OTHERWISE REQUIRES :14
(a) "B
IOMARKER" MEANS A CHARACTERISTIC THAT IS OBJECTIVELY15
MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL16
PROCESSES, PATHOGENIC PROCESSES, OR PHARMACOLOGIC RESPONSES TO17
A SPECIFIC THERAPEUTIC INTERVENTION, INCLUDING KNOWN GENE-DRUG18
INTERACTIONS FOR MEDICATIONS BEING CONSIDERED FOR USE OR19
ALREADY BEING ADMINISTERED . "BIOMARKER" INCLUDES GENE20
MUTATIONS, CHARACTERISTICS OF GENES, OR PROTEIN EXPRESSION.21
(b) "B
IOMARKER TESTING" MEANS THE ANALYSIS OF A PATIENT'S22
TISSUE, BLOOD, OR OTHER BIOSPECIMEN FOR THE PRESENCE OF A23
BIOMARKER. "BIOMARKER TESTING" INCLUDES SINGLE-ANALYTE TESTS,24
MULTIPLEX PANEL TESTS, PROTEIN EXPRESSION, AND WHOLE EXOME ,25
WHOLE GENOME, AND WHOLE TRANSCRIPTOME SEQUENCING . "BIOMARKER26
TESTING" DOES NOT INCLUDE DIRECT-TO-CONSUMER GENETIC TESTS.27
SB24-124
-5- (c) "CONSENSUS STATEMENTS" MEANS STATEMENTS DEVELOPED1
BY AN INDEPENDENT, MULTIDISCIPLINARY PANEL OF EXPERTS UTILIZING2
A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE AND WITH3
A CONFLICT OF INTEREST POLICY . CONSENSUS STATEMENTS ARE4
DEVELOPED FOR SPECIFIC CLINICAL CIRCUMSTANCES AND ARE BASED ON5
THE BEST AVAILABLE EVIDENCE FOR THE PURPOSE OF OPTIMIZING THE6
OUTCOMES OF CLINICAL CARE.7
(d) "FDA"
MEANS THE FOOD AND DRUG ADMINISTRATION IN THE8
U
NITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES .9
(e) "N
ATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES "10
MEANS EVIDENCE-BASED CLINICAL PRACTICE GUIDELINES DEVELOPED BY11
INDEPENDENT ORGANIZATIONS OR MEDICAL PROFESSIONAL SOCIETIES12
UTILIZING A TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE13
AND WITH A CONFLICT OF INTEREST POLICY . CLINICAL PRACTICE14
GUIDELINES:15
(I) E
STABLISH STANDARDS OF CARE INFORMED BY A SYSTEMATIC16
REVIEW OF EVIDENCE AND AN ASSESSMENT OF THE BENEFITS AND RISKS OF17
ALTERNATIVE CARE OPTIONS; AND18
(II) I
NCLUDE RECOMMENDATIONS INTENDED TO OPTIMIZE PATIENT19
CARE.20
(2) O
N AND AFTER JULY 1, 2025, THE MEDICAL ASSISTANCE21
PROGRAM MUST INCLUDE BIOMARKER TESTING AS SET FORTH IN22
SUBSECTIONS (3) AND (4) OF THIS SECTION.23
(3) (a) C
OVERAGE MUST INCLUDE BIOMARKER TESTING FOR24
DIAGNOSIS, TREATMENT, APPROPRIATE MANAGEMENT , AND ONGOING25
MONITORING OF A RECIPIENT 'S DISEASE OR CONDITION TO GUIDE26
TREATMENT DECISIONS WHEN THE TEST IS SUPPORTED BY MEDICAL AND27
SB24-124
-6- SCIENTIFIC EVIDENCE, INCLUDING:1
(I) L
ABELED INDICATIONS FOR AN FDA-APPROVED OR2
FDA-
CLEARED TEST;3
(II) I
NDICATED TESTS FOR AN FDA-APPROVED DRUG;4
(III) W
ARNINGS AND PRECAUTIONS ON FDA-APPROVED DRUG5
LABELS;6
(IV) C
ENTERS FOR MEDICARE AND MEDICAID SERVICES NATIONAL7
COVERAGE DETERMINATIONS OR MEDICARE ADMINISTRATIVE8
CONTRACTOR LOCAL COVERAGE DETERMINATIONS ; OR9
(V) N
ATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES10
AND CONSENSUS STATEMENTS .11
(b) A
MANAGED CARE ENTITY, AS DEFINED IN SECTION 25.5-5-403,12
THAT THE MEDICAL ASSISTANCE PROGRAM CONTRACTS WITH TO DELIVER13
SERVICES SHALL PROVIDE BIOMARKER TESTING IN THE SAME SCOPE ,14
DURATION, AND FREQUENCY AS BIOMARKER TESTING IS PROVIDED TO15
OTHER RECIPIENTS ENROLLED IN THE MEDICAL ASSISTANCE PROGRAM .16
(c) N
OTHING IN THIS SECTION SHALL BE CONSTRUED TO REQUIRE17
COVERAGE OF BIOMARKER TESTING FOR SCREENING PURPOSES .18
(4) T
HE MEDICAL ASSISTANCE PROGRAM MUST NOT IMPOSE A19
LIFETIME LIMIT ON BIOMARKER TESTING FOR A RECIPIENT .20
(5) T
HE MEDICAL ASSISTANCE PROGRAM MUST INCLUDE A CLEAR ,21
READILY ACCESSIBLE, AND CONVENIENT PROCESS FOR A RECIPIENT OR22
PROVIDER TO REQUEST AN APPEAL IF BIOMARKER TESTING IS DENIED . THE23
PROCESS MUST BE READILY ACCESSIBLE ONLINE TO ALL RECIPIENTS AND24
PROVIDERS.25
SECTION 4. Safety clause. The general assembly finds,26
determines, and declares that this act is necessary for the immediate27
SB24-124
-7- preservation of the public peace, health, or safety or for appropriations for1
the support and maintenance of the departments of the state and state2
institutions.3
SB24-124
-8-