Second Regular Session
Seventy-fourth General Assembly
STATE OF COLORADO
REENGROSSED
This Version Includes All Amendments
Adopted in the House of Introduction
LLS NO. 24-0481.01 Brita Darling x2241
SENATE BILL 24-124
Senate Committees House Committees
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
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,
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
SECTION 2. In Colorado Revised Statutes, 25.5-5-202, add15
(1)(z) as follows:16
25.5-5-202. Basic services for the categorically needy - optional17
services. (1) Subject to the provisions of subsection (2) of this section,18
the following are services for which federal financial participation is19
available and that Colorado has selected to provide as optional services20
under the medical assistance program:21
(z) B
IOMARKER TESTING, AS SPECIFIED IN SECTION 25.5-5-337.22
SECTION 3. In Colorado Revised Statutes, add 25.5-5-337 as23
follows:24
25.5-5-337. Biomarker testing - federal authorization - prior25
authorization - definitions. (1) A
S USED IN THIS SECTION, UNLESS THE26
CONTEXT OTHERWISE REQUIRES :27
124
-6- (a) "BIOMARKER" MEANS A CHARACTERISTIC THAT IS OBJECTIVELY1
MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL2
PROCESSES, PATHOGENIC PROCESSES, OR PHARMACOLOGIC RESPONSES TO3
A SPECIFIC THERAPEUTIC INTERVENTION, INCLUDING KNOWN GENE-DRUG4
INTERACTIONS FOR MEDICATIONS BEING CONSIDERED FOR USE OR5
ALREADY BEING ADMINISTERED . "BIOMARKER" INCLUDES GENE6
MUTATIONS, CHARACTERISTICS OF GENES, OR PROTEIN EXPRESSION.7
(b) "B
IOMARKER TESTING" MEANS THE ANALYSIS OF A PATIENT'S8
TISSUE, BLOOD, OR OTHER BIOSPECIMEN FOR THE PRESENCE OF A9
BIOMARKER. "BIOMARKER TESTING" INCLUDES SINGLE-ANALYTE TESTS,10
MULTIPLEX PANEL TESTS, PROTEIN EXPRESSION, AND WHOLE EXOME ,11
WHOLE GENOME, AND WHOLE TRANSCRIPTOME SEQUENCING . "BIOMARKER12
TESTING" DOES NOT INCLUDE DIRECT-TO-CONSUMER GENETIC TESTS.13
14
(2) (a) ON AND AFTER JULY 1, 2024, THE MEDICAL ASSISTANCE15
PROGRAM MUST COVER BIOMARKER TESTING PURSUANT TO THE16
ESTABLISHED PROCESSES FOR DETERMINING COVERAGE OF SERVICES17
BASED ON CLINICAL UTILITY. 18
(b) A
MANAGED CARE ENTITY, AS DEFINED IN SECTION 25.5-5-403,19
THAT THE MEDICAL ASSISTANCE PROGRAM CONTRACTS WITH TO DELIVER20
SERVICES SHALL PROVIDE BIOMARKER TESTING IN THE SAME SCOPE ,21
DURATION, AND FREQUENCY AS BIOMARKER TESTING IS PROVIDED TO22
OTHER MEMBERS
ENROLLED IN THE MEDICAL ASSISTANCE PROGRAM .23
(c) N
OTHING IN THIS SECTION SHALL BE CONSTRUED TO REQUIRE24
COVERAGE OF BIOMARKER TESTING FOR SCREENING PURPOSES .25
(3)
THE MEDICAL ASSISTANCE PROGRAM MUST NOT IMPOSE A26
LIFETIME LIMIT ON BIOMARKER TESTING FOR A MEMBER .27
124
-7- (4) THE MEDICAL ASSISTANCE PROGRAM MUST INCLUDE A CLEAR ,1
READILY ACCESSIBLE, AND CONVENIENT PROCESS FOR A MEMBER OR2
PROVIDER TO REQUEST AN APPEAL IF BIOMARKER TESTING IS DENIED . THE3
PROCESS MUST BE READILY ACCESSIBLE ONLINE TO ALL MEMBERS AND4
PROVIDERS.5
SECTION 4. Safety clause. The general assembly finds,6
determines, and declares that this act is necessary for the immediate7
preservation of the public peace, health, or safety or for appropriations for8
the support and maintenance of the departments of the state and state9
institutions.10
124
-8-