PROVIDER POLICIES & PROCEDURES

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1 PROVIDER POLICIES & PROCEDURES COMPARATIVE GENOMIC HYBRIDIZATION (CGH) MICROARRAY TESTING FOR DEVELOPMENTAL DELAY, AUTISM SPECTRUM DISORDER AND INTELLECTUAL DISABILITY The purpose of this policy is to assist providers enrolled in the Connecticut Medical Assistance Program (CMAP Providers) with the information needed to support a medical necessity determination for array comparative genomic hybridization (acgh) for developmental delay (DD), autism spectrum disorders (ASD) and intellectual disability. By clarifying the information needed for prior authorization of services, HUSKY Health hopes to facilitate timely review of requests so that individuals obtain the medically necessary care they need as quickly as possible. Numerous disorders associated with birth defects or developmental problems are believed to be caused by copy number variants (the deletion or duplication of genomic material). Cytogenetic testing may be requested in order to identify genetic imbalances in infants or children with characteristics of DD, ASD or Intellectual Disability. Cytogenetic testing can provide individuals and families with the information necessary to make fully informed health-care decisions and ensure that individuals receive the necessary supports and services that will appropriately meet their medical, developmental and behavioral health needs and allow for optimal coordination of care. Historically, fluorescence in situ hybridization (FISH) and G-banded karyotyping were the primary tests used to identify genetic imbalances in infants or children believed to have DD, ASD or Intellectual Disability. acgh is a more recently developed cytogenetic technique intended to combine the speed of DNA analysis with a large capacity to scan for genomic abnormalities in a single assay. acgh increases the chromosomal resolution and permits the identification of more copy number variations (CNVs). As a result, acgh increases the diagnostic yield and permits visualization of genomic detail beyond that of conventional methods and may detect genomic gains or losses not identified by G-banded karyotyping. Developmental Delay, Autism Spectrum Disorders and Intellectual Disability Developmental delay occurs when a child has not reached a developmental milestone by the expected time period. Developmental delay can occur in one or more areas e.g. thinking (cognitive) gross or fine motor, language or social skills. Autism Spectrum Disorders (ASDs) are a group of neuro-developmental disorders defined by calculable impairments in communication and social interactions, restricted interests and activities, and stereotypical behaviors. Abnormalities in these three developmental areas tend to occur together in affected individuals. The social skills that develop normally in typically-developing children do not do so in children with ASDs. The cognitive abilities of people with ASDs can vary from gifted to severely challenged. While autistic disorder is the most commonly known type of pervasive developmental disorder (PDD), PDD s also include: Autism Spectrum Disorders (ASD) Childhood Disintegrative Disorders (CDD) Rett Syndrome 1

2 Intellectual Disability is characterized by a significantly below-average score on a test of cognitive ability or intelligence in addition to limitations in the ability to function in areas of daily life, such as self-care, communication, social interactions and school activities. Individuals with intellectual disability can and do learn new skills, but they develop more slowly than children with average intelligence and adaptive skills. The degree of intellectual disability varies from one individual to another and may range from mild to profound. An individual s level of intellectual disability can be defined by their intelligence quotient or by the amount and type of support they need. CLINICAL GUIDELINES Coverage guidelines for acgh are made in accordance with the Department of Social Services (DSS) definition of Medical Necessity and in line with published recommendations and guidelines disseminated by organizations including the American Academy of Neurology, the American Academy of Pediatrics, the American College of Medical Genetics, and the National Institute of Clinical Excellence. The following criteria are guidelines only. Coverage determinations are based on an assessment of the individual and his or her unique clinical needs. If the guidelines conflict with the definition of Medical Necessity, the definition of Medical Necessity shall prevail. The guidelines are as follows: Typical clinical circumstances where acgh testing may be considered medically necessary as a first-line test in the initial post-natal evaluation include individuals with: 1. Multiple anomalies not specific to a well-delineated genetic syndrome; or 2. Apparently non-syndromic developmental delay/intellectual disability; or 3. Autism spectrum disorders. NOTE: EPSDT Special Provision Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) is a federal Medicaid requirement that requires the Connecticut Medical Assistance Program (CMAP) to cover services, products, or procedures for Medicaid enrollees under 21 years of age where the service or good is medically necessary health care to correct or ameliorate a defect, physical or mental illness, or a condition identified through a screening examination. The applicable definition of medical necessity is set forth in Conn. Gen. Stat. Section 17b-259b (2011) [ref. CMAP Provider Bulletin PB ]. PROCEDURE Prior authorization of acgh testing is required. Requests for coverage of acgh testing will be reviewed in accordance with procedures in place for reviewing requests for genetic testing. Coverage determinations will be based upon a review of requested and/or submitted case-specific information. The following information is needed to review requests for acgh testing: 1. Fully completed State of Connecticut, Department of Social Services Outpatient Prior Authorization Request form; 2. Clinical information supporting the need for requested services; and 3. Other information as requested by CHNCT. EFFECTIVE DATE This Policy is effective for prior authorization requests for acgh testing for individuals covered under the HUSKY Health Program on or after July 1,

3 LIMITATIONS N/A CODES: Code Description Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number variants (e.g., Bacterial Artificial Chromosome (BAC) or oligo-based comparative genomic hybridization [CGH] microarray analysis) Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities DEFINITIONS 1. Comparative Genomic Hybridization (CGH): A molecular technique that is used to detect chromosome gain or loss by hybridizing DNA from a target cell and a normal cell. 2. Copy Number Variants (CNVs): An alteration of the DNA of a genome that results in the cell having an abnormal number of copies of one or more sections of the DNA. 3. Current Procedural Terminology (CPT): The most recent edition of a listing, published by the American Medical Association, of descriptive terms and identifying codes for reporting medical services performed by providers. 4. Cytogenetics: A branch of genetic science that focuses on the study of the structure and function of the cell, especially the chromosomes. Cytogenetics includes but is not limited to G-banded karyotyping, fluorescent in situ hybridization (FISH) and comparative genomic hybridization (CGH). 5. G-banded Karyotyping: A molecular chromosome analysis technique which employs Giemsa dye to stain DNA strands. 6. HUSKY A: Connecticut children and their parents or a relative caregiver; and pregnant women may qualify for HUSKY A (also known as Medicaid). Income limits apply. 7. HUSKY B: Uninsured children under the age of 19 in higher income households may be eligible for HUSKY B (also known as the Children s Health Insurance Program) depending on their family income level. Family cost-sharing may apply. 8. HUSKY C: Connecticut residents who are age 65 or older or residents who are ages and who are blind, or have another disability, may qualify for Medicaid coverage under HUSKY C (this includes Medicaid for Employees with Disabilities (MED-Connect), if working). Income and asset limits apply. 9. HUSKY D: Connecticut residents who are ages without dependent children and who: (1) do not qualify for HUSKY A; (2) do not receive Medicare; and (3) are not pregnant, may qualify for HUSKY D (also known as Medicaid for the Lowest-Income populations). 10. HUSKY Health Program: The HUSKY A, HUSKY B, HUSKY C, HUSKY D and HUSKY Limited Benefit programs, collectively. 11. HUSKY Limited Benefit Program or HUSKY, LBP: Connecticut s implementation of limited health insurance coverage under Medicaid for individuals with tuberculosis or for family planning purposes and such coverage is substantially less than the full Medicaid coverage. 12. HUSKY Plus Physical Program (or HUSKY Plus Program): A supplemental physical health program pursuant to Conn. Gen. Stat. 17b-294, for medically eligible members of HUSKY B in Income Bands 1 and 2, whose intensive physical health needs cannot be accommodated within the HUSKY Plan, Part B. 3

4 13. Karotypes: The number and appearance of chromosomes under a light microscope. 14. Medically Necessary or Medical Necessity: (as defined in Connecticut General Statutes 17b- 259b) Those health services required to prevent, identify, diagnose, treat, rehabilitate or ameliorate an individual's medical condition, including mental illness, or its effects, in order to attain or maintain the individual's achievable health and independent functioning provided such services are: (1) Consistent with generally-accepted standards of medical practice that are defined as standards that are based on (A) credible scientific evidence published in peerreviewed medical literature that is generally recognized by the relevant medical community, (B) recommendations of a physician- specialty society, (C) the views of physicians practicing in relevant clinical areas, and (D) any other relevant factors; (2) clinically appropriate in terms of type, frequency, timing, site, extent and duration and considered effective for the individual's illness, injury or disease; (3) not primarily for the convenience of the individual, the individual's health care provider or other health care providers; (4) not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the individual's illness, injury or disease; and (5) based on an assessment of the individual and his or her medical condition. 15. Prior Authorization: A process for approving covered services prior to the delivery of the service or initiation of the plan of care based on a determination by CHNCT as to whether the requested service is medically necessary. CLINICAL MEDICAL POLICY CROSS REFERENCE: Genetic Testing ADDITIONAL RESOURCES AND REFERENCES: Peer Reviewed Publications: 1. Coulter ME, Miller DT, Harris DJ et al. Chromosomal microarray testing influences medical management. Genetics in medicine: official journal of the American College of Medical Genetics. 2011; 13(9): Hillman SC, Pretlove S, Coomarasamy A et al. Additional information from array comparative genomic hybridization technology over conventional karyotyping in prenatal diagnosis: a systematic review and metaanalysis. Ultrasound Obstet Gynecol. 2011; 37(1): Hochstenbach R, van Binsbergen E, Engelen J, et al. Array analysis and karyotyping: workflow consequences based on a retrospective study of 36,325 patients with idiopathic developmental delay in the Netherlands. Eur J Med Genet. 2009; 52(4): Kearney HM, South ST, Wolff DJ, et al. American College of Medical Genetics recommendations for the design and performance expectations for clinical genomic copy number microarrays intended for use in the postnatal setting for detection of constitutional abnormalities. Genet Med. 2011a; 13(7): Kearney HM, Thorland EC, Brown KK, et al. American College of Medical Genetics standards and guidelines for interpretation and reporting of postnatal constitutional copy number variants. Genet Med. 201lb; 13(7): Sagoo GS, Butterworth AS, Sanderson S, et al. Array CGH in patients with learning disability (mental retardation) and congenital anomalies: updated systematic review and meta-analysis of 19 studies and 13,926 subjects. Genet Med. 2009; 11(3): Shen Y, Dies KA, Holm IA, et al. Clinical genetic testing for patients with autism spectrum disorders. Pediatrics. 2010; 125(4):e

5 Government Agency, Medical Society, and Other Authoritative Publications: 1. ACOG Committee opinion no.446: array comparative genomic hybridization in prenatal diagnosis. Obstet Gynecol. 2009; 114(5): Blue Cross Blue Shield Association Technology Evaluation Center (TEC). TEC Special Report: Array Comparative Genomic Hybridization (acgh) for the Genetic Evaluation of Patients with Developmental Delay/Mental Retardation and Autism Spectrum Disorder. TEC Assessments 2009; 24: Tab Johnson CP, Myers SM; American Academy of Pediatrics Council on Children with Disabilities. Identification and evaluation of children with autism spectrum disorders. Pediatrics. 2007; 120(5): Manning M, Hudgins L. Array-based technology and recommendations for utilization in medical genetics practice for detection of chromosomal abnormalities. Genet Med. 2010; 12(11): Manning M, Hudgins L. Use of array-based technology in the practice of medical genetics. Genet Med. 2007; 9(9): Michelson DJ, Shevell MI, Sherr EH et al. Evidence Report: Genetic and metabolic testing on children with global developmental delay: Report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology 2011; 77(17): Miller DT, Adam MP, Aradhya S, et al. Consensus statement: chromosomal microarray is a first-tier clinical diagnostic test for individuals with developmental disabilities or congenital anomalies. Am J Hum Genet. 2010; 86(5): Moeschler JB, Shevell M; American Academy of Pediatrics Committee on Genetics. Clinical genetic evaluation of the child with mental retardation or developmental delays. Pediatrics. 2006; 117(6): National Institute of Clinical Excellence. Autism: recognition, referral and diagnosis of children and young people on the autism spectrum Available at: Accessed on June 18, Schaefer GB, Mendelsohn NJ; Professional Practice and Guidelines Committee. Clinical genetics evaluation in identifying the etiology of autism spectrum disorders. Genet Med. 2008; 10(4): Websites for Additional Information: 1. Center for Disease Control and Prevention (CDC). Autism Spectrum Disorders. For additional information visit the CDC website: Accessed on June 18, Center for Disease Control and Prevention (CDC). Developmental Disabilities. For additional information visit the CDC website: Accessed on June 18, Additional Resources: 1. American Medical Association, Current Procedural Terminology Manual: DSS Provider Bulletin : Consolidated Laboratory Fee Schedule Update, dated June 2012 PUBLICATION HISTORY Status Date Action Taken Original Publication July 2013 Reviewed June 2014 Clinical Quality Subcommittee review. References updated. These changes approved at the June 23, 2014 Clinical Quality 5

6 Subcommittee meeting. Reviewed June 2015 Clinical Quality Subcommittee Review. Updated AMA CPT Manual reference to reflect most current version. Removed section on reimbursement due to change in pricing methodology for genetic testing services, section no longer necessary. These changes approved at the June 15, 2015 Clinical Quality Subcommittee meeting. Updated August 2015 Updated definitions of HUSKY A, B C and D programs at request of DSS. Updated March 2016 Updates to language in introductory paragraph pertaining to purpose of policy. Updates to Clinical Guideline section pertaining to definition of Medical Necessity. Updates throughout policy to reflect importance of person-centeredness when reviewing requests for this service. Changes approved by the Clinical Quality Subcommittee at the March 21, 2016 meeting. Changes approved by DSS on April 11, Reviewed September 2016 Reviewed at the September 26, 2016 Medical Policy Review Meeting Update to reference section. Change approved by the Clinical Quality Subcommittee at the December 20, 2016 meeting. Approved by DSS on January 3,

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