§1028.4. Required coverage for genetic testing for critically ill infants
A.The legislature hereby finds that employing the most comprehensive diagnostic
testing available using advanced molecular techniques including but not limited to traditional
whole genome sequencing, rapid whole genome sequencing, and other genetic and genomic
screening for critically ill infants who are receiving care in intensive care units who have an
unexplained rare disease is yielding life-changing outcomes for critically ill infants.
B.If ordered by the provider, rapid whole genome sequencing testing shall be
covered by all plans in this state. With rapid whole genome sequencing, physicians have been
able to identify the exact cause of rare genetic diseases in an average of three days, instead
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§1028.4. Required coverage for genetic testing for critically ill infants
A. The legislature hereby finds that employing the most comprehensive diagnostic
testing available using advanced molecular techniques including but not limited to traditional
whole genome sequencing, rapid whole genome sequencing, and other genetic and genomic
screening for critically ill infants who are receiving care in intensive care units who have an
unexplained rare disease is yielding life-changing outcomes for critically ill infants.
B. If ordered by the provider, rapid whole genome sequencing testing shall be
covered by all plans in this state. With rapid whole genome sequencing, physicians have been
able to identify the exact cause of rare genetic diseases in an average of three days, instead
of the standard four to six weeks that genetic testing offers and allows physicians to deliver
timely treatment tailored to the infant's specific condition. Rapid whole genome sequencing
empowers parents to join physicians in making informed care decisions, has resulted in
avoiding other costly procedures like tracheotomies or gastric tube insertions, and has led to
fewer days in the hospital.
C.(1) Every health coverage plan renewed, delivered, or issued for delivery in this
state shall include coverage for advanced molecular techniques including but not limited to
traditional whole genome sequencing, rapid whole genome sequencing, and other genetic and
genomic screening that includes individual sequencing, trio sequencing for a parent or
parents of the infant, and ultra-rapid sequencing for an infant who is one year of age or
younger, is receiving inpatient hospital services in an intensive care unit or in a pediatric care
unit, and has a complex illness of unknown etiology.
(2) The coverage provided in this Section may be subject to annual deductibles,
coinsurance, and copayment provisions as are consistent and established under the health
coverage plan. The coverage provided pursuant to this Section may be subject to applicable
evidence-based medical necessity criteria that shall be based on all of the following:
(a) The infant is suspected of having a rare genetic condition that is not diagnosable
by a standard clinical work-up.
(b) The infant has symptoms that suggest a broad differential diagnosis that requires
an evaluation by multiple genetic tests if advanced molecular techniques including but not
limited to traditional whole genome sequencing, rapid whole genome sequencing, and other
genetic and genomic screening are not performed.
(c) Timely identification of a molecular diagnosis is necessary to guide clinical
decision-making, and the advanced molecular techniques including but not limited to
traditional whole genome sequencing, rapid whole genome sequencing, and other genetic and
genomic screening results may guide the treatment or management of the infant's condition.
(d) The infant has at least one of the following conditions:
(i) Multiple congenital anomalies.
(ii) Specific malformations highly suggestive of a genetic etiology.
(iii) Abnormal laboratory tests suggesting the presence of a genetic disease or
complex metabolic phenotype like but not limited to an abnormal newborn screen,
hyperarammonemia, or lactic acidosis not due to poor perfusion.
(iv) Refractory or severe hypoglycemia.
(v) Abnormal response to therapy related to an underlying medical condition
affecting vital organs or bodily systems.
(vi) Severe hypotonia.
(vii) Refractory seizures.
(viii) A high-risk stratification on evaluation for a brief resolved unexplained event
with any of the following:
(aa) A recurrent event without respiratory infection.
(bb) A recurrent event witnessed seizure-like event.
(cc) A recurrent cardiopulmonary resuscitation.
(ix) Abnormal chemistry levels including but not limited to electrolytes, bicarbonate,
lactic acid, venous blood gas, and glucose suggestive of inborn error of metabolism.
(x) Abnormal cardiac diagnostic testing results suggestive of possible
channelopathies, arrhythmias, cardiomyopathies, myocarditis, or structural heart disease.
(xi) Family genetic history related to the infant's condition.
D. For purposes of this Section, "health coverage plan" means any hospital, health,
or medical expense insurance policy, hospital or medical service contract, employee welfare
benefit plan, contract, or other agreement with a health maintenance organization or a
preferred provider organization, health and accident insurance policy, or any other insurance
contract of this type in Louisiana, including group insurance plan, a self-insurance plan, and
the office of group benefits programs. "Health coverage plan" does not include a plan
providing coverage for excepted benefits defined in R.S. 22:1061, limited benefit health
insurance plans, and short-term policies that have a term of less than twelve months.