2022 Regular Session ENROLLED
SENATE BILL NO. 154
BY SENATORS TALBOT, BERNARD, BOUDREAUX, BOUIE, CARTER, CONNICK,
CORTEZ, FESI, HARRIS, JACKSON, MIZELL, MORRIS, PEACOCK,
POPE, SMITH, STINE, WARD AND WOMACK AND
REPRESENTATIVE LANDRY
1 AN ACT
2 To enact R.S. 22:1028.4 and R.S. 40:1081.12, relative to health insurance coverage of
3 genetic testing for critically ill infants with no diagnosis; to require health insurance
4 coverage of genetic testing for critically ill infants with no diagnosis; to provide for
5 definitions; to provide relative to Medicaid coverage for genetic testing of critically
6 ill infants; to provide for coverage for rapid whole genome sequencing testing of
7 certain infants; to provide for the duties of the secretary of the Louisiana Department
8 of Health; and to provide for related matters.
9 Be it enacted by the Legislature of Louisiana:
10 Section 1. R.S. 22:1028.4 is hereby enacted to read as follows:
11 §1028.4. Required coverage for genetic testing for critically ill infants
12 A. The legislature hereby finds that employing the most comprehensive
13 diagnostic testing available using advanced molecular techniques including but
14 not limited to traditional whole genome sequencing, rapid whole genome
15 sequencing, and other genetic and genomic screening for critically ill infants
16 who are receiving care in intensive care units who have an unexplained rare
17 disease is yielding life-changing outcomes for critically ill infants.
18 B. If ordered by the provider, rapid whole genome sequencing testing
19 shall be covered by all plans in this state. With rapid whole genome sequencing,
20 physicians have been able to identify the exact cause of rare genetic diseases in
ACT No. 501
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1 an average of three days, instead of the standard four to six weeks that genetic
2 testing offers and allows physicians to deliver timely treatment tailored to the
3 infant's specific condition. Rapid whole genome sequencing empowers parents
4 to join physicians in making informed care decisions, has resulted in avoiding
5 other costly procedures like tracheotomies or gastric tube insertions, and has
6 led to fewer days in the hospital.
7 C.(1) Every health coverage plan renewed, delivered, or issued for
8 delivery in this state shall include coverage for advanced molecular techniques
9 including but not limited to traditional whole genome sequencing, rapid whole
10 genome sequencing, and other genetic and genomic screening that includes
11 individual sequencing, trio sequencing for a parent or parents of the infant, and
12 ultra-rapid sequencing for an infant who is one year of age or younger, is
13 receiving inpatient hospital services in an intensive care unit or in a pediatric
14 care unit, and has a complex illness of unknown etiology.
15 (2) The coverage provided in this Section may be subject to annual
16 deductibles, coinsurance, and copayment provisions as are consistent and
17 established under the health coverage plan. The coverage provided pursuant to
18 this Section may be subject to applicable evidence-based medical necessity
19 criteria that shall be based on all of the following:
20 (a) The infant is suspected of having a rare genetic condition that is not
21 diagnosable by a standard clinical work-up.
22 (b) The infant has symptoms that suggest a broad differential diagnosis
23 that requires an evaluation by multiple genetic tests if advanced molecular
24 techniques including but not limited to traditional whole genome sequencing,
25 rapid whole genome sequencing, and other genetic and genomic screening is not
26 performed.
27 (c) Timely identification of a molecular diagnosis is necessary to guide
28 clinical decision-making, and the advanced molecular techniques including but
29 not limited to traditional whole genome sequencing, rapid whole genome
30 sequencing, and other genetic and genomic screening results may guide the
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1 treatment or management of the infant's condition.
2 (d) The infant has at least one of the following conditions:
3 (i) Multiple congenital anomalies.
4 (ii) Specific malformations highly suggestive of a genetic etiology.
5 (iii) Abnormal laboratory tests suggesting the presence of a genetic
6 disease or complex metabolic phenotype like but not limited to an abnormal
7 newborn screen, hyperarammonemia, or lactic acidosis not due to poor
8 perfusion.
9 (iv) Refractory or severe hypoglycemia.
10 (v) Abnormal response to therapy related to an underlying medical
11 condition affecting vital organs or bodily systems.
12 (vi) Severe hypotonia.
13 (vii) Refractory seizures.
14 (viii) A high-risk stratification on evaluation for a brief resolved
15 unexplained event with any of the following:
16 (aa) A recurrent event without respiratory infection.
17 (bb) A recurrent event witnessed seizure-like event.
18 (cc) A recurrent cardiopulmonary resuscitation.
19 (ix) Abnormal chemistry levels including but not limited to electrolytes,
20 bicarbonate, lactic acid, venous blood gas, and glucose suggestive of inborn
21 error of metabolism.
22 (x) Abnormal cardiac diagnostic testing results suggestive of possible
23 channelopathies, arrhythmias, cardiomyopathies, myocarditis, or structural
24 heart disease.
25 (xi) Family genetic history related to the infant's condition.
26 D. For purposes of this Section, "health coverage plan" means any
27 hospital, health, or medical expense insurance policy, hospital or medical
28 service contract, employee welfare benefit plan, contract, or other agreement
29 with a health maintenance organization or a preferred provider organization,
30 health and accident insurance policy, or any other insurance contract of this
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1 type in Louisiana, including group insurance plan, a self-insurance plan, and
2 the office of group benefits programs. "Health coverage plan" does not include
3 a plan providing coverage for excepted benefits defined in R.S. 22:1061, limited
4 benefit health insurance plans, and short-term policies that have a term of less
5 than twelve months.
6 Section 2. R.S. 40:1081.12 is hereby enacted to read as follows:
7 §1081.12. Medicaid coverage; genetic testing of critically ill infants
8 A.(1) Subject to the approval of the Centers for Medicare and Medicaid
9 Services, the Louisiana medical assistance program shall include coverage on
10 a fee-for-service basis for rapid whole genome sequencing testing of an infant
11 who is enrolled in a Medicaid managed care plan and meets all of the following
12 criteria:
13 (a) Is one year of age or younger.
14 (b) Has a complex illness of unknown etiology.
15 (c) Is receiving inpatient hospital services in an intensive care unit or in
16 a pediatric care unit.
17 (2) Coverage provided for the infant pursuant to this Section shall
18 include individual sequencing, trio sequencing of the parents of the infant, and
19 ultra-rapid sequencing.
20 B. The secretary of the Louisiana Department of Health shall take all
21 actions necessary to implement the provisions of this Section, including but not
22 limited to both of the following:
23 (1) Promulgation of rules and regulations in accordance with the
24 Administrative Procedure Act to provide for Medicaid coverage pursuant to
25 this Section.
26 (2) Submission to the Centers for Medicare and Medicaid Services of any
27 new waiver application, amendment to an existing waiver, or Medicaid state
28 plan amendment to provide for Medicaid coverage pursuant to this Section.
29 Section 3. The provisions of Section 1 of this Act shall become effective on January
30 1, 2023.
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1 Section 4. The provisions of this Section and Sections 2 and 3 of this Act shall
2 become effective on August 1, 2022.
PRESIDENT OF THE SENATE
SPEAKER OF THE HOUSE OF REPRESENTATIVES
GOVERNOR OF THE STATE OF LOUISIANA
APPROVED:
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