2023 Regular Session ENROLLED
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.
1 AN ACT
2 To enact R.S. 22:1028.5, relative to health insurance coverage; to require health insurance
3 coverage for biomarker testing for the purposes of diagnosis, treatment, appropriate
4 management, or ongoing monitoring of an individual's disease or condition; to
5 provide coverage requirements; to provide for definitions; to provide for
6 applicability; 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 or any other medical
13 condition more accurately and greatly improve the individual's outcome by
14 providing personalized care.
15 B.(1) Any health coverage plan renewed, delivered, or issued for delivery
16 in this state shall include coverage of biomarker testing.
17 (2) The coverage provided in this Section may be subject to annual
18 deductibles, coinsurance, and copayment provisions as are consistent with those
19 established under the health coverage plan. Biomarker testing shall be covered
20 for the purposes of diagnosis, treatment, appropriate management, or ongoing
21 monitoring of an individual's disease or condition when the test provides clinical
22 utility as demonstrated by medical and scientific evidence, including any one of
23 the following items:
24 (a) Labeled indications for diagnostic tests approved or cleared by the
ACT No. 324
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1 United States Food and Drug Administration or indicated diagnostic tests for
2 a drug approved by the United States Food and Drug Administration.
3 (b) Warnings and precautions listed on a United States Food and Drug
4 Administration approved drug label.
5 (c) National Coverage Determinations of the Centers for Medicare and
6 Medicaid Services or Local Coverage Determinations of Medicare
7 Administrative Contractors.
8 (d) Nationally recognized clinical practice guidelines.
9 (3) This Section does not require a health coverage plan to cover
10 biomarker testing for screening purposes.
11 C. The individual and healthcare provider shall have access to a clear,
12 readily accessible, and convenient process to request an exception to a coverage
13 policy or adverse utilization review determination of a health coverage plan.
14 The process shall be made readily accessible on the health coverage plan's
15 website or be clearly outlined in the notification of adverse determination.
16 D. A health coverage plan shall ensure that the coverage prescribed in
17 Subsection B of this Section is provided in a manner that limits disruptions in
18 care, including the need for multiple biopsies or biospecimen samples.
19 E. As used in this Section, the following definitions apply unless the
20 context indicates otherwise:
21 (1) "Biomarker" means a characteristic that is objectively measured and
22 evaluated as an indicator of normal biological processes, pathogenic processes,
23 or pharmacologic responses to a specific therapeutic intervention, including
24 known gene-drug interactions for medication being considered for use or
25 currently administered. A "biomarker" includes but is not limited to gene
26 mutations, characteristics of genes, or protein expression.
27 (2) "Biomarker testing" means the analysis of a patient's tissue, blood,
28 or other biospecimen for the presence of a biomarker. "Biomarker testing"
29 includes but is not limited to single-analyte tests, multi-plex panel tests, protein
30 expression, whole exome, whole genome, and whole transcriptome sequencing.
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1 (3)(a) "Clinical utility" means a test result to provide information that
2 is used in the formulation of a treatment or monitoring strategy that informs a
3 patient's outcome and impacts the clinical decision.
4 (b) The most appropriate test may include both information that is
5 actionable and information that cannot be immediately used in the formulation
6 of a clinical decision.
7 (4) "Health coverage plan" means any hospital, health, or medical
8 expense insurance policy, hospital or medical service contract, employee welfare
9 benefit plan, contract, or other agreement with a health maintenance
10 organization or a preferred provider organization, health and accident
11 insurance policy, or any other insurance contract of this type in this state,
12 including a group insurance plan or self-insurance plan, and the office of group
13 benefits. "Health coverage plan" does not include a plan providing coverage for
14 excepted benefits defined in R.S. 22:1061, limited benefit health insurance plans,
15 or short-term policies that have a term of less than twelve months.
16 (5) "Nationally recognized clinical practice guidelines" means
17 evidence-based clinical guidelines developed by independent organizations or
18 medical professional societies utilizing a transparent methodology and reporting
19 structure and with a conflict-of-interest policy. The guidelines establish
20 standards of care informed by a systematic review of evidence and an
21 assessment of the benefits and risks of alternative care options and include
22 recommendations intended to optimize patient care.
23 Section 2. The provisions of this Act shall apply to any new policy, contract,
24 program, or health coverage plan issued on or after the January first immediately following
25 the effective date of this Act. Any policy, contract, or health coverage plan in effect prior to
26 the effective date of this Act shall convert to conform to the provisions of this Act on or
27 before the renewal date, but no later than the first January first that is at least one year after
28 the effective date of this Act.
29 Section 3.(A) The provisions of Sections 1 and 2 of this Act shall become effective
30 when an Act of the Louisiana Legislature containing a specific appropriation of monies for
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1 the implementation of the provisions of this Act becomes effective.
2 (B) The provisions of this Section shall become effective upon signature by the
3 governor or, if not signed by the governor, upon expiration of the time for bills to become
4 law without signature by the governor, as provided by Article III, Section 18 of the
5 Constitution of Louisiana. If vetoed by the governor and subsequently approved by the
6 legislature, the provisions of this Section shall become effective on the day following such
approval.
PRESIDENT OF THE SENATE
SPEAKER OF THE HOUSE OF REPRESENTATIVES
GOVERNOR OF THE STATE OF LOUISIANA
APPROVED:
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