Health coverage plans in this state must cover certain genetic testing, including rapid whole genome sequencing, for qualifying critically ill infants.
§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. Acts 2022, No. 501, §1, eff. Jan. 1, 2023.