SENATE BILL 24-124
BY SENATOR(S) Michaelson Jenet and Rich, Buckner, Cutter, Exum,
Ginal, Gonzales, Hansen, Hinrichsen, Kirkmeyer, Kolker, Marchman,
Mullica, Pelton B., Pelton R., Priola, Roberts, Will, Winter F., Fenberg;
also REPRESENTATIVE(S) Hartsook and Duran, Bird, Boesenecker,
Brown, English, Hamrick, Jodeh, Kipp, Lieder, Lindsay, Lukens,
McCormick, McLachlan, Rutinel, Titone, McCluskie.
C
ONCERNING REQUIRING HEALTH -CARE COVERAGE FOR BIOMARKER
TESTING
.
Be it enacted by the General Assembly of the State of Colorado:
SECTION 1. In Colorado Revised Statutes, 10-16-104, add (28) as
follows:
10-16-104. Mandatory coverage provisions - definitions - rules.
(28) Biomarker testing. (a) A
LL LARGE GROUP HEALTH BENEFIT PLANS
AND
, TO THE EXTENT THAT SUCH COVERAGE IS NOT IN ADDITION TO THE
BENEFITS PROVIDED PURSUANT TO THE BENCHMARK PLAN
, ALL INDIVIDUAL
AND SMALL GROUP HEALTH BENEFIT PLANS SHALL PROVIDE COVERAGE FOR
BIOMARKER TESTING PURSUANT TO THIS SUBSECTION
(28).
NOTE: This bill has been prepared for the signatures of the appropriate legislative
officers and the Governor. To determine whether the Governor has signed the bill
or taken other action on it, please consult the legislative status sheet, the legislative
history, or the Session Laws.
________
Capital letters or bold & italic numbers indicate new material added to existing law; dashes
through words or numbers indicate deletions from existing law and such material is not part of
the act. (b) COVERAGE MUST INCLUDE BIOMARKER TESTING FOR DIAGNOSIS ,
TREATMENT, APPROPRIATE MANAGEMENT , AND ONGOING MONITORING OF A
COVERED PERSON
'S DISEASE OR CONDITION TO GUIDE TREATMENT DECISIONS
WHEN THE TEST IS SUPPORTED BY MEDICAL AND SCIENTIFIC EVIDENCE
,
INCLUDING:
(I) L
ABELED INDICATIONS FOR AN FDA-APPROVED OR
FDA-CLEARED TEST;
(II) I
NDICATED TESTS FOR AN FDA-APPROVED DRUG;
(III) W
ARNINGS AND PRECAUTIONS ON FDA-APPROVED DRUG
LABELS
;
(IV) C
ENTERS FOR MEDICARE AND MEDICAID SERVICES NATIONAL
COVERAGE DETERMINATIONS OR MEDICARE ADMINISTRATIVE CONTRACTOR
LOCAL COVERAGE DETERMINATIONS
; OR
(V) NATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES ,
CONSENSUS STATEMENTS , AND PEER-REVIEWED STUDIES.
(c) T
HE COVERAGE REQUIRED BY THIS SUBSECTION (28) IS SUBJECT
TO ANNUAL DEDUCTIBLES
, COPAYMENTS, OR COINSURANCE REQUIREMENTS
UNDER THE HEALTH BENEFIT PLAN BUT IS NOT SUBJECT TO ANY ANNUAL OR
LIFETIME MAXIMUM BENEFIT LIMIT
.
(d) T
HE COVERAGE REQUIRED BY THIS SUBSECTION (28) MUST BE
PROVIDED IN A MANNER THAT LIMITS UNREASONABLE DISRUPTIONS IN CARE
,
INCLUDING LIMITING THE NEED FOR MULTIPLE BIOPSIES OR BIOSPECIMEN
SAMPLES
.
(e) N
OTHING IN THIS SUBSECTION (28) SHALL BE CONSTRUED TO
REQUIRE COVERAGE FOR BIOMARKER TESTING FOR SCREENING PURPOSES
.
(f) A
CARRIER MAY REQUIRE PRIOR AUTHORIZATION FOR BIOMARKER
TESTING IN THE SAME MANNER THAT PRIOR AUTHORIZATION IS REQUIRED
FOR ANY OTHER COVERED BENEFIT AND CONSISTENT WITH SECTION
10-16-112.5.
(g) (I) W
ITHIN ONE HUNDRED TWENTY DAYS AFTER THE EFFECTIVE
PAGE 2-SENATE BILL 24-124 DATE OF THIS SUBSECTION (28), THE DIVISION SHALL SUBMIT TO THE
FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES
:
(A) A
DETERMINATION AS TO WHETHER THE BENEFIT SPECIFIED IN
THIS SUBSECTION
(28) IS IN ADDITION TO ESSENTIAL HEALTH BENEFITS AND
WOULD BE SUBJECT TO DEFRAYAL BY THE STATE PURSUANT TO
42 U.S.C.
SEC. 18031 (d)(3)(B); AND
(B) A REQUEST THAT THE FEDERAL DEPARTMENT OF HEALTH AND
HUMAN SERVICES CONFIRM THE DIVISION
'S DETERMINATION WITHIN SIXTY
DAYS AFTER RECEIPT OF THE DIVISION
'S REQUEST AND SUBMISSION OF ITS
DETERMINATION
.
(II) T
HIS SUBSECTION (28) APPLIES TO, AND THE DIVISION SHALL
IMPLEMENT THE PROVISIONS OF THIS SUBSECTION
(28) FOR, LARGE
EMPLOYER HEALTH BENEFIT PLANS ISSUED OR RENEWED IN THIS STATE ON
OR AFTER
JANUARY 1, 2025.
(III) T
HIS SUBSECTION (28) APPLIES TO, AND THE DIVISION SHALL
IMPLEMENT THE REQUIREMENTS OF THIS SUBSECTION
(28) FOR, INDIVIDUAL
AND SMALL GROUP HEALTH BENEFIT PLANS ISSUED OR RENEWED IN THIS
STATE TWELVE MONTHS AFTER THE EARLIER OF THE FOLLOWING
:
(A) T
HE DIVISION RECEIVES CONFIRMATION FROM THE FEDERAL
DEPARTMENT OF HEALTH AND HUMAN SERVICES THAT THE COVERAGE
SPECIFIED IN THIS SUBSECTION
(28) DOES NOT CONSTITUTE AN ADDITIONAL
BENEFIT THAT REQUIRES DEFRAYAL BY THE STATE PURSUANT TO
42 U.S.C.
SEC. 18031 (d)(3)(B);
(B) T
HE FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES
HAS OTHERWISE INFORMED THE DIVISION THAT THE COVERAGE DOES NOT
REQUIRE STATE DEFRAYAL PURSUANT TO
42 U.S.C. SEC. 18031 (d)(3)(B); OR
(C) MORE THAN THREE HUNDRED SIXTY -FIVE DAYS HAVE PASSED
SINCE THE DIVISION SUBMITTED ITS DETERMINATION AND REQUEST FOR
CONFIRMATION THAT THE COVERAGE SPECIFIED IN THIS SUBSECTION
(28) IS
NOT AN ADDITIONAL BENEFIT THAT REQUIRES STATE DEFRAYAL PURSUANT
TO
42 U.S.C. SEC. 18031 (d)(3)(B), AND THE FEDERAL DEPARTMENT OF
HEALTH AND HUMAN SERVICES HAS FAILED TO RESPOND TO THE REQUEST
WITHIN THAT PERIOD
, IN WHICH CASE THE DIVISION SHALL CONSIDER THE
PAGE 3-SENATE BILL 24-124 FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES ' UNREASONABLE
DELAY A PRECLUSION FROM REQUIRING DEFRAYAL BY THE STATE
.
(h) T
HE COMMISSIONER SHALL IMPLEMENT THIS SUBSECTION (28)
AND SHALL ADOPT RULES CONSISTENT WITH AND AS ARE NECESSARY TO
IMPLEMENT THIS SUBSECTION
(28).
(i) A
S USED IN THIS SUBSECTION (28):
(I) "B
IOMARKER" MEANS A CHARACTERISTIC THAT IS OBJECTIVELY
MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGICAL
PROCESSES
, PATHOGENIC PROCESSES, OR PHARMACOLOGIC RESPONSES TO A
SPECIFIC THERAPEUTIC INTERVENTION
, INCLUDING KNOWN GENE -DRUG
INTERACTIONS FOR MEDICATIONS BEING CONSIDERED FOR USE OR ALREADY
BEING ADMINISTERED
. "BIOMARKER" INCLUDES GENE MUTATIONS ,
CHARACTERISTICS OF GENES, OR PROTEIN EXPRESSION.
(II) "B
IOMARKER TESTING" MEANS THE ANALYSIS OF A PATIENT 'S
TISSUE
, BLOOD, OR OTHER BIOSPECIMEN FOR THE PRESENCE OF A
BIOMARKER
. "BIOMARKER TESTING" INCLUDES SINGLE-ANALYTE TESTS,
MULTIPLEX PANEL TESTS, PROTEIN EXPRESSION, AND WHOLE EXOME, WHOLE
GENOME
, AND WHOLE TRANSCRIPTOME SEQUENCING . "BIOMARKER TESTING"
DOES NOT INCLUDE DIRECT-TO-CONSUMER GENETIC TESTS.
(III) "C
ONSENSUS STATEMENTS" MEANS STATEMENTS DEVELOPED BY
AN INDEPENDENT
, MULTIDISCIPLINARY PANEL OF EXPERTS UTILIZING A
TRANSPARENT METHODOLOGY AND REPORTING STRUCTURE AND WITH A
CONFLICT OF INTEREST POLICY
. CONSENSUS STATEMENTS ARE DEVELOPED
FOR SPECIFIC CLINICAL CIRCUMSTANCES AND ARE BASED ON THE BEST
AVAILABLE EVIDENCE FOR THE PURPOSE OF OPTIMIZING THE OUTCOMES OF
CLINICAL CARE
.
(IV) "N
ATIONALLY RECOGNIZED CLINICAL PRACTICE GUIDELINES "
MEANS EVIDENCE-BASED CLINICAL PRACTICE GUIDELINES DEVELOPED BY
INDEPENDENT ORGANIZATIONS OR MEDICAL PROFESSIONAL SOCIETIES
UTILIZING A TRANSPARENT METHODOL OGY AND REPORTING STRUCTURE AND
WITH A CONFLICT OF INTEREST POLICY
. CLINICAL PRACTICE GUIDELINES:
(A) E
STABLISH STANDARDS OF CARE INFORMED BY A SYSTEMATIC
REVIEW OF EVIDENCE AND AN ASSESSMENT OF THE BENEFITS AND RISKS OF
PAGE 4-SENATE BILL 24-124 ALTERNATIVE CARE OPTIONS; AND
(B) INCLUDE RECOMMENDATIONS INTENDED TO OPTIMIZE PATIENT
CARE
.
SECTION 2. Safety clause. The general assembly finds,
determines, and declares that this act is necessary for the immediate
preservation of the public peace, health, or safety or for appropriations for
PAGE 5-SENATE BILL 24-124 the support and maintenance of the departments of the state and state
institutions.
____________________________ ____________________________
Steve Fenberg
Julie McCluskie
PRESIDENT OF SPEAKER OF THE HOUSE
THE SENATE OF REPRESENTATIVES
____________________________ ____________________________
Cindi L. Markwell Robin Jones
SECRETARY OF CHIEF CLERK OF THE HOUSE
THE SENATE OF REPRESENTATIVES
APPROVED________________________________________
(Date and Time)
_________________________________________
Jared S. Polis
GOVERNOR OF THE STATE OF COLORADO
PAGE 6-SENATE BILL 24-124