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2023 Regular Session
SENATE BILL NO. 104
BY SENATORS STINE, DUPLESSIS, FESI, JACKSON, ROBERT MILLS, PEACOCK,
SMITH AND TALBOT
Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana.
GENETICS. Provides for health insurance coverage of genetic testing for diseases and other
medical conditions. (8/1/23)
1 AN ACT
2 To enact R.S. 22:1028.5, relative to health coverage insurance; to require health insurance
3 coverage for biomarker testing shall be covered for the purposes of diagnosis,
4 treatment, appropriate management, or ongoing monitoring of an individual's disease
5 or condition; to provide coverage requirements; to provide for the definition of
6 health coverage plan; to provide for definitions; and to provide for related matters.
7 Be it enacted by the Legislature of Louisiana:
8 Section 1. R.S. 22:1028.5 is hereby enacted to read as follows:
9 ยง1028.5. Required coverage for biomarker testing
10 A. The legislature hereby finds that medical advances in genomic testing
11 for diseases and other medical conditions including but not limited to
12 biomarker testing can identify characteristics of disease more accurately and
13 greatly improve the individual's outcome by providing personalized care.
14 B.(1) Any health coverage plan renewed, delivered, or issued for delivery
15 in this state shall include coverage of biomarker testing.
16 (2) The coverage provided in this Section may be subject to annual
17 deductibles, coinsurance, and copayment provisions as are consistent with those
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions. SB NO. 104
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1 established under the health plan. Biomarker testing shall be covered for the
2 purposes of diagnosis, treatment, appropriate management, or ongoing
3 monitoring of an individual's disease or condition when the test is supported by
4 medical and scientific evidence, including any one of the following items:
5 (a) Labeled indications for diagnostic tests approved or cleared by the
6 United States Food and Drug Administration or indicated diagnostic tests for
7 a drug approved by the United States Food and Drug Administration.
8 (b) Warnings and precautions listed on a United States Food and Drug
9 Administration approved drug label.
10 (c) Centers for Medicare and Medicaid Services National Coverage
11 Determination or a Medicare Administrative Contractor Local Coverage
12 Determination.
13 (d) Nationally recognized clinical practice guidelines and consensus
14 statements.
15 C. The individual and healthcare provider shall have access to a clear,
16 readily accessible, and convenient processes to request an exception to a
17 coverage policy or adverse utilization review determination of a health coverage
18 plan. The process shall be made readily accessible on the health coverage plan's
19 website.
20 D. A health coverage plan shall ensure coverage as defined in Subsection
21 B of this Section is provided in a manner that limits disruptions in care,
22 including the need for multiple biopsies or biospecimen samples.
23 E. For purposes of this Section, "health coverage plan" means any
24 hospital, health, or medical expense insurance policy, hospital or medical
25 service contract, employee welfare benefit plan, contract, or other agreement
26 with a health maintenance organization or a preferred provider organization,
27 health and accident insurance policy, or any other insurance contract of this
28 type in this state, including a group insurance plan or self-insurance plan, and
29 the office of group benefits. "Health coverage plan" does not include a plan
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1 providing coverage for excepted benefits defined in R.S. 22:1061, limited benefit
2 health insurance plans, or short-term policies that have a term of less than
3 twelve months.
4 F. As used in this Section, the following definitions apply unless the
5 context indicates otherwise:
6 (1) "Biomarker" means a characteristic that is objectively measured and
7 evaluated as an indicator of normal biological processes, pathogenic processes,
8 or pharmacologic responses to a specific therapeutic intervention, including
9 known gene-drug interactions for medication being considered for use or is
10 being administered. A biomarker includes but is not limited to gene mutations,
11 characteristics of genes, or protein expression.
12 (2) "Biomarker testing" means the analysis of a patient's tissue, blood,
13 or other biospecimen for the presence of a biomarker. Biomarker testing
14 includes but is not limited to single-analyte tests, multi-plex panel tests, protein
15 expression, whole exome, whole genome, and whole transcriptome sequencing.
16 (3) "Consensus statements" means statements developed by an
17 independent, multidisciplinary panel of experts utilizing a transparent
18 methodology and reporting structure and with a conflict-of-interest policy. The
19 statements are aimed at specific clinical circumstances and based on the best
20 available evidence for the purpose of optimizing the outcomes of clinical care.
21 (4) "Nationally recognized clinical practice guidelines" means
22 evidence-based clinical guidelines developed by independent organizations or
23 medical professional societies utilizing a transparent methodology and reporting
24 structure and with a conflict-of-interest policy. The guidelines establish
25 standards of care informed by a systematic review of evidence and an
26 assessment of the benefits and risks of alternative care options and include
27 recommendations intended to optimize patient care.
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Coding: Words which are struck through are deletions from existing law;
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The original instrument and the following digest, which constitutes no part
of the legislative instrument, were prepared by Beth O'Quin.
DIGEST
SB 104 Engrossed 2023 Regular Session Stine
Proposed law requires any health coverage plan renewed, delivered, or issued for delivery,
in this state to include coverage for biomarker testing for the purpose of diagnosis, treatment,
appropriate management, or ongoing monitoring of an individual's disease or condition when
the test is supported by medical and scientific evidence, including any one of the following:
(1)Labeled indications for diagnostic tests approved or cleared by the United States
Food and Drug Administration (FDA) or indicated diagnostic tests for a drug
approved by the FDA.
(2)Warnings and precautions listed on a FDA approved drug label.
(3)Centers for Medicare and Medicaid Services National Coverage Determination or
a Medicare Administrative Contractor Local Coverage Determination.
(4)Nationally recognized clinical practice guidelines and consensus statements.
Proposed law authorizes the coverage is subject to annual deductibles, coinsurance, and
copayment provisions as are consistent with those established under the health plan.
Proposed law requires individuals and healthcare providers have access to clear, readily
accessible, convenient processes to request exceptions to a coverage policy or adverse
determination review determination of a health coverage plan. Requires the process to be
included on a health coverage plan's website.
Proposed law requires a health coverage plan to ensure coverage under proposed law is
provided in a manner that limits disruptions in care, including the need for multiple biopsies
or biospecimen samples.
Proposed law defines biomarker, biomarker testing, consensus statements, health coverage
plans, and Nationally recognized clinical practice guidelines.
Effective August 1, 2023.
(Adds R.S. 22:1028.5)
Summary of Amendments Adopted by Senate
Committee Amendments Proposed by Senate Committee on Insurance to the original
bill
1. Provides that tests are diagnostic tests.
2. Makes technical changes.
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Coding: Words which are struck through are deletions from existing law;
words in boldface type and underscored are additions.