Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Evaluation and Management of Autism Spectrum Disorders (ASD)

Policy #:07.03.07r

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

EVALUATION OF AUTISM SPECTRUM DISORDERS (ASD)

The services listed below are the most frequently performed components of an ASD evaluation, and are considered medically necessary and, therefore, covered:

PREGNANCY, DELIVERY, NEONATAL COURSE
  • Review of the pregnancy, delivery, and early neonatal course

INTERVIEW
  • Parent(s) and/or child interview, including any siblings

HISTORY AND PHYSICAL
  • Complete history and physical examination of the affected individual

DEVELOPMENTAL SCREENING
  • Developmental screening for ASD using standardized developmental screening tool(s)

ELECTROENCEPHALOGRAM (EEG)
  • If the individual has an associated seizure disorder, suspicion of subclinical seizure, or a developmental degenerative condition (e.g., a clinically significant loss of social and communicative function), an EEG may be performed.

AUDIOLOGIC AND/OR VISION EVALUATION
  • If the individual has a hearing impairment and/or an associated language/developmental delay, an audiologic and/or vision evaluation may be performed.

SPEECH, LANGUAGE, AND/OR COMMUNICATION EVALUATION
  • If the individual has a speech, language, and/or communication delay, and/or sensory-motor symptoms that interfere with feeding, an assessment by a speech-language pathologist may be performed.

LABORATORY EVALUATION
  • Laboratory evaluation as indicated, including the following:
    • Measurement of blood lead level
    • Quantitative plasma amino acid assays to detect phenylketonuria (a rare cause of ASD and intellectual disability)
    • Selective metabolic testing

GENETIC TESTING FOR GENETIC DISORDERS ASSOCIATED WITH ASD

Genetic testing for genetic disorders associated with ASD include any of the following when the results for the genetic testing have the potential to impact the clinical management of the child:
  • Fragile X Mental Retardation 1 (FMR1) gene analysis for Fragile X syndrome (FXS), performed as first-tier genetic testing for individuals with any of the following:
    • Intellectual disability (or if intellectual disability cannot be excluded) and developmental delay
    • A family history of FXS or undiagnosed intellectual disability
    • Affected individuals or relatives of affected individuals who have had a positive cytogenetic FXS test result who are seeking further counseling related to the risk of carrier status
  • Whole genome chromosomal microarray analysis (CMA) performed as first tier genetic testing in the presence of ASD according to accepted Diagnostic and Statistical Manual of Mental Disorder(DSM-5) criteria, even in the absence of any other stigmata of other genetic syndromes.
  • Second-tier genetic testing including any of the following, performed for diagnosing a genetic abnormality in children with ASD according to accepted DSM-5 criteria:
    • Methyl CpG binding protein 2 (MECP2) genetic testing, performed to confirm a diagnosis of Rett syndrome in children with signs/symptoms of Rett syndrome when there is uncertainty in the clinical diagnosis
    • Phosphatase and tensin homolog (PTEN) genetic testing, performed for children with a head circumference above the 98th percentile

EXPERIMENTAL/INVESTIGATIONAL
Panel testing using next-generation sequencing (NGS) in all cases of suspected genetic disorders in children with ASD is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

PSYCHIATRIC AND/OR PSYCHOLOGICAL SERVICES

Refer to the contracted behavioral health/mental health vendor for psychiatric and/or psychological services eligible for coverage in individuals with ASD.

MANAGEMENT OF AUTISM SPECTRUM DISORDERS (ASD)

The following components of the management of ASD are considered medically necessary and, therefore, covered:

PHYSICAL, OCCUPATIONAL, AND/OR SPEECH THERAPY(IES)
In accordance with the terms defined in the applicable medical policies, benefit contracts on these topics, or where a state mandate provides for such coverage, physical, occupational, and/or speech therapy(ies) are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has an established and current (within 24 months), documented diagnosis of ASD consistent with the DSM-5 criteria, using validated assessment tools (e.g., Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI-R), Parent Evaluation Developmental Stages (PEDS), Checklist for Autism in Toddlers (M-CHAT), Ages and Stages Questionnaire (ASQ), or Brigance), made by a qualified licensed treating professional provider including a physician, physician assistant, psychologist, or certified registered nurse practitioner as is consistent with state licensing requirements.
  • The individual has a history of a clinically significant impairment that interferes with the ability to negotiate their environment, communicate, learn, and/or demonstrate appropriate social behavior, which may include any of the following:
    • Impaired motor skills and/or musculoskeletal system involvement
    • Impaired activities of daily living
    • Impaired speech, language, and/or communication
  • The therapy is rendered by or under the direction of a professional provider who is appropriately licensed to perform the therapy and who is eligible under the terms of the member's benefit contract.
  • The individual's progress in meeting the objectives of the treatment plan is measured (frequency, rate, symptom intensity or duration, or objective measures of baseline levels) on an ongoing basis for adjustment or refinement.
  • The individual's parent(s) and/or caregiver(s) are willing and able to participate and follow the training and support that are incorporated into the treatment plan.
  • The individual has a documented treatment plan for transition through the continuum of interventions, services, and settings, along with discharge criteria.
NEW JERSEY MEMBERS
In accordance with state mandate requirements effective February 9, 2010, for members enrolled in New Jersey's commercial products, coverage of physical, occupational, and/or speech therapy(ies) will be considered in those situations where the treatment is not restorative (i.e., does not restore previously possessed function, skill or ability) for the management of ASD.

DISCONTINUATION OF PHYSICAL, OCCUPATIONAL, AND/OR SPEECH THERAPY(IES)
The assessment of the individual's progress in meeting the objectives of the treatment plan shall be reviewed every six months, unless it is determined that an earlier assessment is required. Upon evaluation of the treatment plan, if it is determined that services (e.g., physical, occupational, and/or speech therapy[ies]) should be discontinued, any of the following criteria must be documented:
  • Treatment is making the symptoms or negative behavior(s) persistently worse.
  • No meaningful, measurable change has been documented in the individual's functioning and/or behavior(s) for a period of three months of optimal treatment.
    • Changes must be sustained over time beyond the end of the actual treatment session and generalizable outside of the treatment setting to the individual's residence and to the larger community within which the individual resides.
  • The individual has achieved adequate stabilization of functions and/or the challenging behavior(s), and less-intensive modes of therapy are appropriate.
    • It is appropriate to restart treatment if measurable deterioration in functioning and/or behavior(s) occurs with less-intensive modes of therapy.
  • The individual's parent(s) and/or caregiver(s) demonstrate adequate skill in administering a long-term home-based program.
  • The individual's parent(s) and/or caregiver(s) are not willing and are unable to participate and follow the training and support that are incorporated into the treatment plan.
  • The individual demonstrates an inability to maintain long-term gains from the proposed treatment plan.

PSYCHIATRIC AND/OR PSYCHOLOGICAL SERVICES
Refer to the contracted behavioral health/mental health vendor for psychiatric and/or psychological services eligible for coverage in individuals with ASD.

APPLIED BEHAVIOR ANALYSIS (ABA) AND/OR OTHER METHODOLOGIES TO PROMOTE LEARNING
Refer to the contracted behavioral health/mental health vendor for ABA and/or other services to promote learning that are eligible for coverage for individuals with ASD.

For all products of the Company, the behavior methodology of ABA (e.g., discrete trial training, pivotal response training, incidental teaching), structured teaching (e.g., TEACCH), and developmental models (e.g., Denver model, the developmental, individual-difference, relationship-based [DIR] floor-time model) used to promote learning for individuals with ASD to enhance verbal and non-verbal communication, improve developmentally appropriate self-care, teach social skills, and reduce maladaptive behaviors (e.g., harm to self or others), are considered experimental/investigational and, therefore, not covered, as the safety and/or effectiveness of these programs have not been established by review of available published peer-reviewed literature. However, coverage for ABA used to promote learning is covered in accordance with the following state mandates:
  • PENNSYLVANIA MEMBERS
    In accordance with state mandate requirements effective July 1, 2009, for members enrolled in Pennsylvania's commercial products, ABA is covered for the management of ASD.
  • NEW JERSEY MEMBERS
    In accordance with state mandate requirements effective February 9, 2010, for members enrolled in New Jersey's commercial products, ABA and related structured behavioral programs are covered for the management of ASD.

Applied behavioral analysis for the treatment of individuals with ASD is covered when a state mandate requires coverage and when ALL of the following criteria are met (for members enrolled in New Jersey’s commercial products, other related structured behavioral services are covered in addition to ABA):
  • The individual has an established and current (within 24 months), documented diagnosis of ASD consistent with the DSM-5 criteria, using validated assessment tools (e.g., Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview (ADI-R), Parent Evaluation Developmental Stages (PEDS), Checklist for Autism in Toddlers (M-CHAT), Ages and Stages Questionnaire (ASQ), or Brigance ) made by a qualified licensed treating professional provider including a physician, physician assistant, psychologist, or certified registered nurse practitioner as is consistent with state licensing requirements. The qualified licensed treating professional provider is other than the behavior analyst practitioner performing services related to ABA and/or other related structured behavioral services.
  • Applied behavioral analysis services are provided by or under the supervision of, a Board Certified Behavior Analyst-Doctoral (BCBA-D) or Board Certified Behavior Analyst (BCBA)-graduate-level certification in behavior analysis
  • As determined by validated developmental assessment tools, the individual cannot participate at an age appropriate level in home, school or community activities because of the presence of behavioral excess and/or the absence of functional skills that interfere with participation in these activities, and the target behaviors or skill deficits identified for ABA and/or other related structured behavioral interventions meet either of the following:
    • The target behavior or skill is one standard deviation or more below the mean, or
    • Represents a behavior that poses significant threat of harm to the individual or others.
  • Development and adaptive skills assessment has been completed within the last 12 months using a validated assessment tool (e.g., Vineland, Adaptive Behavior Assessment System [ABASAS])
  • Functional behavioral assessment (FBA) using validated tools has been completed by a qualified behavior analyst certified by the Behavior Analyst Certification Board (BACB)
    • The FBA includes baseline information on the individual’s adaptive functioning within the last 12 months.
  • There is an expectation on the part of the treating professional provider who has completed the initial evaluation, that the individual's behavior and skills will improve to a clinically meaningful extent, in at least two settings (home, school, community) with ABA and/or other related structured behavioral services provided by, or supervised by, a certified ABA provider.
  • Individualized, documented treatment plan has been developed by a licensed professional provider (e.g., MD/DO, licensed psychologist) with the following elements:
    • There are specific, quantifiable goals, that relate to developmental deficits or behaviors that pose a significant risk of harm to the recipient or others.
    • Objective, observable, and quantifiable metrics are utilized to measure change toward the specific goal behaviors.
    • Documentation that adjunctive treatments (e.g., psychotherapy, social skills training, medication services, educational services) have been considered for inclusion in the treatment plan, with the rationale for exclusion.
    • The individualized treatment plan is valid for six months, unless there is clear evidence of regression necessitating earlier changes in the treatment plan.
  • Individualized, documented treatment plan is reviewed and approved every six months by the behavioral health/mental health vendor.
  • The individual's parent(s) and/or caregiver(s) commit to participate in the goals of the treatment plan.
  • The individual is medically stable and does not require 24-hour medical/nursing monitoring or procedures provided in a hospital level of care

CONTINUATION OF APPLIED BEHAVIOR ANALYSIS (ABA) AND/OR OTHER METHODOLOGIES TO PROMOTE LEARNING
The assessment of the individual's progress in meeting the objectives of the treatment plan shall be reviewed every six months unless it is determined that an earlier assessment is required. The continuation of ABA is covered for the treatment of individuals with ASD when a state mandate requires coverage and when ALL of the following criteria are met (for members enrolled in New Jersey’s commercial products, the following are conditions for the continuation of other related structured behavioral services in addition to ABA):
  • The individual shows improvement from baseline in skill deficits and problematic behaviors targeted in the approved treatment plan using validated assessments of adaptive functioning.
  • As determined by validated developmental assessment tools, the individual still cannot participate at an age appropriate level in home, school or community activities because of the presence of behavioral excess and/or the absence of functional skills that interfere with participation in these activities, and the target behaviors or skill deficits identified for ABA and/or other related structured behavioral interventions meet one or more of the following:
    • The target behavior or skill is one standard deviation or more below the mean, or
    • Represents a behavior that that poses significant threat of harm to the individual or others.
  • The individual's parent(s) and/or caregiver(s) demonstrate continued commitment to participation in the individual's treatment plan and demonstrate the ability to apply those skills in naturalized settings as documented in the clinical record.
  • The gains made toward development norms and behavior goals cannot be maintained if care is reduced.
  • Behavior issues are not exacerbated by the treatment process.
  • The individual has the required cognitive capacity to benefit from the care provided and to retain and generalize treatment gains.

DISCONTINUATION OF APPLIED BEHAVIOR ANALYSIS (ABA) AND/OR OTHER METHODOLOGIES TO PROMOTE LEARNING
The assessment of the individual's progress in meeting the objectives of the treatment plan shall be reviewed every six months unless it is determined that an earlier assessment is required. The following are conditions for the discontinuation of ABA (for members enrolled in New Jersey’s commercial products, the following are conditions for the discontinuation of other related structured behavioral services in addition to ABA):
  • Behavioral issues are exacerbated by the treatment.
  • The individual shows improvement from baseline in targeted skill deficits such that goals are achieved or maximum benefit has been reached.
  • The individual's parent(s) and/or caregiver(s) have refused treatment recommendations.
  • The individual is unlikely to continue to benefit or maintain gains from continued care.

SERVICES THAT ARE NOT ELIGIBLE FOR REIMBURSEMENT IN THE EVALUATION AND MANAGEMENT OF ASD

SCHOOL, CAMP SETTINGS
Treatment of ASD that is provided at or by a school or camp, whether or not as part of an individualized education program (IEP), is a standard benefit contract exclusion for all products of the Company and is not eligible for coverage by the Company with the following exception:
  • For certain Pennsylvania members covered under an insured employer that has 51 or more employees, treatment of ASD is covered in a school setting

NEUROPSYCHOLOGICAL TESTING (NPT)
NPT is considered not medically necessary and, therefore, not covered for ASD unless the individual has an associated neurologically based condition that requires such testing. In those instances, indicate the primary diagnosis code that represents the associated neurologically based condition.

ALTERNATIVE THERAPIES AND COMPLEMENTARY MEDICINE
Alternative therapies and complementary medicine (e.g., nutritional supplements, high doses of pyridoxine and magnesium, casein-free and gluten-free diets) are standard benefit contract exclusions for most of the Company's products and are not eligible for reimbursement consideration. When an alternative therapy is elected as a group option, coverage is dictated by the terms of the rider purchased by the group. Therefore, individual benefits must be verified, as coverage may vary between groups and products.

EXPERIMENTAL/INVESTIGATIONAL SERVICES
Other therapies and treatments (e.g., auditory integration training [AIT], facilitative communication [FC], immune globulin therapy [IVIg], secretin, chelation therapy) used in the management of ASD are considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of these services cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Documentation of the performing provider's qualifications must be made available to Company upon request.

TREATMENT PLAN DOCUMENTATION

The individual's treatment plan must document all of the following:
  • Significant history
  • Diagnosis of ASD and rationale for requiring services
  • Any related professional provider's orders
  • The goals for the services, which must be:
    • Specific and measurable
    • Individualized
    • Updated on a frequent basis
    • Based on the individual's progress
      • To improve function and/or behavior significantly
      • To prevent loss of attained skill or function and/or produce socially significant improvement in human behavior (reduce interfering behaviors)
  • Type, amount, duration, and frequency of services
  • Direct observation, measurement, and functional analysis of the relations between environment and behavior
  • Interventions such as, but not limited to, physical, occupational, speech therapy(ies), ABA and/or other related structured behavioral services, that are consistent with current techniques and standards
  • Any contraindications to a course of services
  • Parent(s)' and/or caregiver(s)' awareness and understanding of the diagnoses, prognoses, and goals of services
  • When appropriate, a summary of past services and the results that were achieved
  • Reasonable expectation, based on the individual's clinical history, that withdrawal of treatment will result in the decompensation or the recurrence of signs and symptoms
  • Signature of the treating licensed professional provider (e.g., MD/DO, licensed psychologist)

DOCUMENTATION FOR DATES OF SERVICE

Treatment and modality notes for dates that services are provided and billed for must include the following documentation:
  • Date of service
  • Specific service provided
  • If modalities are utilized, documentation of the length of time spent in each modality
  • If exercises or equipment are utilized, documentation of the specific activity, time, and/or number of repetitions
    • Exercises or modalities that require therapist supervision should be supported with an indication of the time spent and the level of skill required by the individual
  • The individual's response to the service
  • Skilled, ongoing reassessment of the individual’s progress towards established goals
  • Objective, measurable, and specific documentation of progress towards goals using consistent and comparable methods
  • Changes to the treatment plan or objective reasoning for why the individual has not progressed towards goals
  • Name and credentials of the treating clinician

Guidelines

The 2013 guidelines update from American College of Medical Genetics (ACMG) state that a stepwise or tiered approach to the clinical genetic diagnostic evaluation of autism spectrum disorder (ASD) is recommended, with the recommendation for the first tier to include fragile X syndrome and chromosomal microarray analysis (CMA).

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, evaluation for ASD is covered under the medical benefits of the Company’s products when the medical necessity criteria in this medical policy are met or when state mandate(s) require coverage for such services. However, except where required by state mandate(s), services that are identified in this policy as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the Company.

The provision of benefits for all services related to outpatient physical, occupational, and/or speech therapy(ies) is in accordance with the individual's benefit contract and varies by product and group. Therefore, individual member benefits must be verified. Some services may be subject to state mandates, medical necessity criteria, coverage limits, precertification or preapproval, or existing contractual exclusions.

When purchased as a group benefit, pharmacy services for ASD are covered under the pharmacy benefits of the Company's products. Individual benefits must be verified.

Management of ASD may not routinely include psychiatric and/or psychological services for all individuals enrolled in a Company product. For information about psychiatric and/or psychological services eligible for coverage in individuals with ASD, refer to the contracted behavioral health/mental health vendor.

The frequency of physical, occupational, and/or speech therapy(ies) varies among individuals with ASD, based primarily on the severity of their condition. Treatment approaches, responses to treatment, co-morbidities, age, and/or general health characteristics may also affect the frequency of care.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state in which the group benefit contract is issued determine the mandated coverage.

Description

AUTISM SPECTRUM DISORDER (ASD)

Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interactions across multiple contexts, including deficits in social reciprocity, nonverbal communicative behaviors used for social interaction, and skills in developing, maintaining, and understanding relationships. In addition, ASD is characterized by restricted, repetitive patterns of behavior or interests. Symptoms cause clinically significant impairment of functionality.

The American Psychiatric Association (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM-5),consolidated the previously distinct autism subtypes (i.e., autistic disorder, childhood disintegrative disorder, Asperger's syndrome, and pervasive developmental disorder not otherwise specified) into one unifying diagnosis of autism spectrum disorder (ASD). The diagnostic criteria for ASD reflects a scientific consensus of published peer-reviewed literature and clinical experience. Researchers found that these separate diagnoses were not consistently applied across different clinics and treatment centers. Under the DSM-5 criteria, individuals with ASD must now show symptoms from early childhood, even if those symptoms are not recognized until later. It has been suggested that this criterion will now encourage an earlier diagnosis of ASD. A study published by Huerta et al (2012) provided a comprehensive assessment of the DSM-5 criteria for ASD based on symptom extraction from previously collected data. The study found that DSM-5 criteria identified 91 percent of the children with clinical DSM-IV pervasive developmental disorder (PDD) diagnoses, suggesting that most children with the DSM-IV PDD diagnoses may retain their diagnosis of ASD based on the DSM-5 criteria. The DSM-5 defines ASD by the presence of the following:
  • Persistent deficits in social communication and social interaction across multiple contexts
  • Restricted, repetitive patterns of behavior, interests, or activities
  • Symptoms must be present in the early developmental period (typically recognized in the first two years of life)
  • Symptoms cause clinically significant impairment in social, occupational, or other important areas of current functioning.

Autism disorder was first described by Dr. Leo Kanner in 1943. Autism impacts the normal development of the brain in the areas of communication skills and social interaction; it is four times more common in males than females. The onset of the condition usually occurs within the first three years of life. Individuals who are diagnosed with autism may exhibit some of the following characteristics, which can range in intensity from mild to severe, and appear in various combinations: difficulty expressing needs; a preference towards solitude; a tendency towards tantrums; difficulty with socialization; making little or no eye contact; having an inappropriate attachment to objects; an over- or under-sensitivity to pain; not recognizing danger; exhibiting strange play; and unresponsiveness to normal teaching methods and/or verbal cues. Many children with autism also have varying degrees of intellectual disability.

EVALUATION

According to a 2007 clinical report for the American Academy of Pediatrics (AAP), ASD is generally believed to be a biologically based neurodevelopmental disorder that involves multiple genes and demonstrates great phenotypic variation. Although ASD is believed to be mainly genetic in origin, environmental factors may modulate phenotypic expression. Despite this, the exact cause is still unknown. Early identification of ASD is important because it allows early intervention, etiologic investigation, and counseling regarding recurrence risk and improved overall outcomes.

To identify individuals with ASD, a comprehensive evaluation should include historical information such as a review of pregnancy, labor, delivery, early neonatal course, developmental history, and communicative and motor milestones. The medical history should include screening for sensory deficits (e.g., hearing or visual impairments), as well as a discussion about other medical conditions and specific signs and symptoms. The history and physical examination may assist in the search for known etiologic or associated conditions. The National Institute of Mental Health has identified conditions that may accompany ASD, including, but not limited to:
  • Seizures
    Seizures are present in approximately 20 percent to 35 percent of individuals with ASD.
  • Sensory problems
    Sensory problems result from the inability to balance the senses appropriately. Many individuals with ASD are highly attuned or even painfully sensitive to certain sounds, textures, tastes, and smells.
  • Intellectual disability
    Intellectual disability is a behaviorally defined disorder of complex human abilities with many genetic and nongenetic causes.
  • Fragile X syndrome (FXS)
    FXS is the most common form of inherited intellectual disability. It is caused by a mutation in a Fragile X Mental Retardation 1 [FMR1] gene. FXS can be detected with FMR1 testing. ASD occurs more frequently in individuals with FXS.
  • Tuberous sclerosis complex (TSC)
    TSC is a genetic disorder that causes benign tumors to form in the brain and other vital organs. The disorder is characterized by hypopigmented macules on the skin, which are visualized on Wood's lamp examination. Some individuals with TSC experience developmental delays, intellectual disability, and autism.
  • Angelman syndrome (AS)
    AS is a neurodevelopmental disorder that is caused by a deficiency of a maternally transmitted gene. AS can be detected with fluorescent in situ hybridization (FISH) or small nuclear ribonucleoprotein polypeptide N and ubiquitin protein ligase E3A (SNRPN/UBE3A) testing. AS is characterized by severe intellectual disability, ataxia, a happy social disposition, and, in some instances, a secondary diagnosis of ASD.
  • Rett syndrome
    Rett syndrome, which was first diagnosed in 1966 by Andreas Rett, is a neurologic disorder that is diagnosed primarily in females. Children with Rett syndrome develop normally for the first 6 to 18 months. However, changes in behavior and a regression or loss of gross motor skills (e.g., walking, moving), the ability to speak, and using hands purposefully begin to manifest themselves. Children with Rett syndrome tend to exhibit the repetition of meaningless gestures, such as constant hand-washing or hand-wringing. Rett syndrome is caused by sequence variants in the methyl CpG binding protein 2 (MECP2) gene, which is located on the X chromosome. Rett syndrome is a discrete neurologic disorder and is not considered a sub-diagnosis under ASD, although children with Rett syndrome may have ASD.

SCREENING/DIAGNOSTIC SERVICES

Due to the complexity of ASD, many professional societies such as the Child Neurology Society and the American Academy of Neurology have emphasized the importance of interdisciplinary collaboration in screening and diagnosing the condition.

The AAP recommends that developmental surveillance should be incorporated at every well-child preventive care visit, and any concerns raised by surveillance should be addressed through standardized developmental screening tests. AAP recommends that an autism-specific screening tool should be administered to all children at the 18- and 24-month well-child visits, since symptoms of ASD are often present at these ages, and effective early intervention strategies are available. Additional screening might be needed if a child is at high risk for ASD (e.g., having a sibling with ASD) or if symptoms are present. Screening tools do not provide an individual diagnosis but, rather, serve to assess the need for referral for a possible diagnosis. Screening specifically for ASD should be performed on children who demonstrate delays on developmental surveillance using a validated ASD screening tool (e.g., Checklist for Autism in Toddlers [CHAT], Modified Checklist for Autism in Toddlers [M-CHAT], Modified Checklist for Autism in Toddlers with Follow-up [M-CHAT-F], Modified Checklist for Autism in Toddlers Revised, with Follow-up [MCHAT-R/F], Social Communication Questionnaire [SCQ], Social Responsiveness Scale [SRS], Autism Screening Questionnaire, Pervasive Developmental Disorder Screening Test II [PDDST-II]). Other screening tools include Ages and Stages Questionnaires (ASQ), Parents’ Evaluation of Developmental Status (PEDS), Battelle Developmental Inventory Screening Tool, 2nd ed (BDI-ST), Denver-II Developmental Screening Test and Brigance.

Professional providers involved in diagnosing ASD must be knowledgeable and experienced with comprehensive standardized diagnostic tools that are specific for ASD. Diagnostic tools for ASD include parent and/or caregiver reports, as well as observational diagnostic instruments (e.g., Autism Diagnostic Observation Schedule-Generic [ADOS-G], Autism Diagnostic Interview-Revised [ADI-R], Childhood Autism Rating Scale [CARS], Gilliam Autism Rating Scale-Second Edition [GARS-2]). It is also stressed that professionals involved in diagnosing ASD must be knowledgeable and experienced in using guidelines such as the American Psychiatric Association's criteria outlined in the DSM-5.

ELECTROENCEPHALOGRAM (EEG)
EEGs are obtained when the individual has clinical suggestions of an associated condition, such as a seizure disorder or a degenerative condition.

AUDIOLOGIC, SPEECH, AND LANGUAGE EVALUATION
An audiologic evaluation and comprehensive speech and language evaluation should always be performed in any child who has language delays, whether ASD symptoms are present or not. The literature has documented that conductive, sensorineural, or mixed hearing loss can occur with ASD.

LABORATORY EVALUATION
Currently, there is no laboratory test specific for ASD. Laboratory evaluations may be indicated in children with suspected ASD to determine an associated condition. For example, the National Center for Environmental Health of the Centers for Disease Control and Prevention recommends that children with developmental delays and pica, who may spend a prolonged period in the oral stage, be screened for lead poisoning. Additionally, quantitative plasma amino acid assays should be considered even if the findings from the neonatal screen for phenylketonuria were negative.

GENETIC COUNSELING
Because the recurrence rate of idiopathic ASD is significant in siblings (5 to 10 percent) of affected children, genetic counseling may be provided after a diagnosis of ASD to offer parents information about recurrence risks in subsequent children.

GENETIC TESTING
Complex ASD, which comprises approximately 20 percent to 30 percent of cases of ASD, is defined by the presence of dysmorphic features and/or microcephaly. Essential autism, approximately 70 percent to 80 percent of cases of autism, is defined as ASD in the absence of dysmorphology. The etiology of ASD may be associated with genetic abnormalities. Genetic abnormalities associated with ASD include cytogenetically visible chromosomal abnormalities (five percent), single-gene disorders (five percent), and copy-number variants (CNVs; segments of DNA longer than 1 kilobase that differ in copy number from a reference genome)(10 percent to 20 percent). Hence, ASD is not a single-gene disorder but a rather complex disorder resulting from simultaneous genetic variations with multiple genes with interactions between genetic, epigenetic, and environmental factors. The genetic component of ASD is an area of active research. Current guidelines from the American Academy of Pediatrics and the American Academy of Neurology with the Child Neurology Society, recommend cytogenetic evaluation to look for certain kinds of chromosomal abnormalities that may be causally related to ASD. Research has identified various genetic disorders associated with ASD; however, the total number of individuals with ASD who have a known genetic condition is only a small percentage of the whole. Conventional genetic testing methods to identify associated conditions of ASD may include G-banded karyotyping and/or fluorescent in situ hybridization (FISH). However, these tests have been found to have a low diagnostic yield, with most cases without an identification of a chromosomal abnormality associated with the individual's condition.

Genetic testing of individuals with ASD has changed significantly with the introduction of chromosomal microarray (CMA) technologies, which increase the chromosomal resolution and detect deletions and duplications called copy number variants (CNV) of genetic material that typically are too small to be detected by the conventional G-banded karyotyping studies. The ability to examine the genome at this high resolution has resulted in the discovery of widespread copy number variation in the human genome. As a result, there is a much higher diagnostic yield with CMA (i.e., proportion of tested individuals with clinically relevant genomic abnormalities). The results of current studies suggest that mutations in specific locations of the gene play a significant role in identifying the risk of ASD (Sanders 2012). Professional societies and organizations, such as the American College of Medical Genetics and Genomics and the International Standard Cytogenomic Array Consortium, have recommended CMA testing as first-line evaluation when genetic evaluation is desired as opposed to first obtaining a karyotype. It has been well demonstrated in individuals with apparent nonsyndromic DD/ID, or suspected ASD and accompanying malformations, that the diagnostic yield is much higher and is higher than the yield of G-banded karyotyping. A portion of the increased diagnostic yield from CMA over G-banded karyotype analysis comes from the discovery that some chromosomal rearrangements that appear balanced by G-banded karyotype analysis are found to have small imbalances with greater resolution. However, CMA testing could not entirely replace G-banded karyotyping in this population because of the inability of CMA to detect balanced rearrangements, but these are a small proportion of abnormal results. Despite these limitations, CMA would be an appropriate choice for clinical genetic testing for individuals with ASD, despite a small number of balanced rearrangements that would be undetectable.

CMA consistently demonstrates a high sensitivity and specificity. Most studies involving individuals with developmental concerns, dysmorphic features, and/or congenital abnormalities, and with no known karyotypic abnormality, suggest a detection rate between 7.5 percent and 15.6 percent with whole-genome array, and demonstrate clinical validity of CMA (Xiang 2008, Schoumans 2005, Shaw-Smith 2004). Studies of clinical utility of CMA in the diagnostic evaluation of individuals with ASD suggest that the diagnosis of a chromosomal imbalance using this genetic testing may lead to changes in the medical management of the individual, including referrals to new specialists, initiating screening protocols, avoiding additional diagnostic tests, and improving access to services. In addition, establishing a specific diagnosis typically allows for more accurate genetic counseling and recurrent risk estimation (Saam 2008).

Currently, two methods of CMA are used in the clinical setting, comparative genomic hybridization (aCGH) and single-nucleotide polymorphism (SNP). Comparative genomic hybridization (aCGH) and SNP use different techniques to scan the genome for CNVs. Through these studies, new information has emerged regarding the contribution of genome CNVs in ASD. In addition, de novo CNVs are observed about four times more frequently in children with ASD than in normal individuals. The primary concern with both aCGH and SNP microarray testing is the identification of CNVs of unknown clinical significance. In addition, the microarrays will not detect balanced chromosome rearrangements (i.e., balanced translocations or inversions) or imbalances not covered by the probes on the microarray.

According to the AAP (2010), CMA analysis had the highest detection rate among clinically available genetic tests for individuals with ASD, and should be considered as part of the initial diagnostic evaluation of individuals with ASD.

The American College of Medical Genetics (ACMG) has updated guidelines (March 2013) stating that a tiered approach to the clinical genetic diagnostic evaluation of ASD tailored to the individual is recommended, taking into consideration the findings of history and physical examination. A tiered or stepwise evaluation can be designed such that testing performed earlier in tiers have a greater expected diagnostic yield, lower invasiveness of testing, and a greater potential for intervention, and are more easily employed. The recommendation for first-tier evaluation is to include for specified individuals, FXS [fragile X syndrome] and CMA, and for second-tier evaluation to include for specified individuals, methyl CpG binding protein 2 (MECP2) and phosphatase and tensin homolog (PTEN) testing. The guideline states that this approach will evolve with continued advancements in diagnostic testing and improved understanding of the ASD phenotype. ACMG does not specify what type of CMA platform should be used (i.e., aCGH versus SNP) in the clinical genetic diagnostic evaluation of ASD. Additional conditions have been reported in association with an ASD phenotype, but none of these has been evaluated in a large prospective cohort.

Next-generation sequencing (NGS) platforms perform massively parallel sequencing, during which millions of fragments of DNA from a single sample are sequenced in unison. NGS autism panel has been proposed to detect single-gene causes of ASD and possibly identify a syndrome that involves ASD in individuals with normal array-based testing. These genes have been associated with nonsyndromic ASD and genes associated with conditions involved in the differential diagnosis of Rett syndrome and/or Angelman syndrome. Available published peer-reviewed literature on analytic and clinical validity, clinical utility, and variants of unknown significance using NGS panels are lacking.

MANAGEMENT

According to the National Institute of Child Health and Human Development, currently there is no definitive, single treatment for the management of ASD. Individuals with ASD have a wide spectrum of behaviors and abilities so that no one approach is equally effective for all, and not all individuals in outcome studies have benefited to the same degree. In addition, individuals with ASD may require new and/or multiple episodes of care or modifications to the frequency and duration of existing services. These changes are typically based on re-examination due to the severity of the current condition, as well as changes related to growth and development, caregivers, environment, or functional demands. There is insufficient scientific support to determine in advance the optimal frequency, duration, or intensity of services needed (e.g., physical therapy, occupational therapy, speech therapy) for a particular individual or a particular behavioral target symptom.

The primary goals of management of ASD are to minimize the core features and associated deficits, maximize functional independence and quality of life, and alleviate family distress (Myers et al, 2007). The management of ASD may also include services such as, but not limited to the following:

PHARMACOLOGICAL MANAGEMENT
A consensus on the recommended guidelines for the use of medication in the management of ASD has not been reached. Currently, the US Food and Drug Administration (FDA) has not approved any medications specifically for the treatment of ASD. However, medications may be used to treat some of the symptoms associated with ASD (e.g., aggression, hyperactivity, inattention, depression, anxiety). The FDA has approved risperidone (Risperdal®) for the symptomatic treatment of irritability, including aggression, deliberate self-injury, and temper tantrums in children and adolescents, ages 5 years to 16 years, with ASD. More recently, the FDA has approved aripiprazole (Abilify®) for the treatment of irritability associated with ASD.

PHYSICAL THERAPY
Physical therapy is a medically prescribed treatment for physical disabilities or impairments that result from disease, injury, congenital anomaly, and/or prior therapeutic intervention. Features of ASD may include delays in the achievement and advancement of motor skills and sensorimotor adaption, atypical postures and movement patterns, deficient balance reactions, decreased muscle performance and range of mobility, and a general lack of physical fitness. Associated conditions may include, but are not limited to: hypotonia, limb apraxia, and joint laxities. Early intervention is critical in promoting more typical gross motor development and facilitating better long-term outcomes.

OCCUPATIONAL THERAPY
Occupational therapy practitioners work with individuals with ASD, as well as with parents, caregivers, educators, and other team members in a variety of settings, including the home, school, clinic, and community, to assist the individual with successful participation and adaptation in school, home, and social environments. According to the American Occupational Therapy Association (AOTA), goals for young individuals with ASD frequently focus on enhancing an individual's sensory processing, sensorimotor performance, social/behavioral performance, self care, and participation in play. In older individuals with ASD, occupational therapy goals focus on social/behavioral performance, activities of daily living, and independence in the community.

SPEECH THERAPY
Speech therapy is the medically prescribed treatment for speech and language disorders due to disease, surgery, injury, congenital anomalies, speech/language delay, or previous therapeutic processes that result in communication disabilities and/or swallowing disorders. According to the American Speech-Language-Hearing Association (ASHA), speech-language pathologists play a critical role in screening, diagnosing, and enhancing the development of social communication and quality of life of children, adolescents, and adults with ASD. They work with individuals with ASD to help diagnose and treat specific speech and language deficits, as well as related feeding disorders. There is no single approach that is equally effective for all individuals with ASD, and, based on outcome studies, not all individuals benefit to the same degree. Speech-language consultative services should be aimed at helping the communicative partner (e.g., teacher, parent, caregiver, peer, sibling) provide the support and employ specific teaching strategies to enhance active engagement in natural learning environments.

PSYCHIATRIC SERVICES
Direct or consultative services are provided by a professional provider who specializes in psychiatry to diagnose ASD and/or to diagnose and treat comorbid psychiatric disorders that are exhibited by the individual with ASD.

PSYCHOLOGICAL SERVICES
Direct or consultative services are provided by a psychologist to diagnose ASD and/or to diagnose and treat comorbid psychological disorders that are exhibited by the individual with ASD.

APPLIED BEHAVIOR ANALYSIS (ABA) AND OTHER METHODOLOGIES TO PROMOTE LEARNING
Methodologies to promote learning are believed to enhance verbal and non-verbal communication, improve developmentally appropriate self-care, teach social skills, and reduce maladaptive behaviors (e.g., harm to self or others). These methodologies are based on several model programs, including behavioral, structured teaching, and/or developmental programs.

Among the many methodologies available for the management of ASD, ABA is arguably the most studied treatment modality in the field. It is generally believed that ABA is the process of applying interventions that are based on the principles of learning (e.g., positive reinforcement) derived from experimental psychology research to systematically change behavior. It can also be used to teach new skills and demonstrate that the interventions used are responsible for the observable improvements in behavior. ABA methods are reportedly used to replace maladaptive, interfering behaviors with more desirable, adaptive behaviors and to narrow the conditions under which maladaptive, interfering behaviors occur. In addition, ABA is believed to teach new skills through implicit instruction and repetition, generalize behaviors to new environments or situations, and maintain learned behaviors. For example, clear instruction with assistance (e.g., demonstration, prompting) is given to the individual, and when the individual gives a correct response, the instructor gives positive reinforcement.

Components of ABA include the following:
  • An initial assessment through observations that focus on strengths and weaknesses of the individual
  • Individualized treatment goals that are guided by the data from the initial assessment and are defined in observable terms.
  • A written treatment plan or set of instructions for teaching each behavior and/or skill, developed by a professional provider.
  • Training for the individual's parent(s) and/or caregiver(s) to implement the treatment plan consistently both within and outside formal treatment sessions.
  • A curriculum that focuses on all of the following:
    • Breaking down skills into manageable pieces
    • Building upon skills so that an individual can learn in a natural environment
    • Teaching the individual to combine skills acquired in more complex ways
  • Documented frequent assessments of the individual's progress in measurable outcomes, using direct observational measurement methods with verification by secondary observers. As progress is made, guidance is systematically reduced.
  • No reinforcement for problem behaviors.

There are many techniques used within the realm of ABA. Common techniques include, but are not limited to, the following:
  • Discrete trial training (DTT) is behaviorally based instruction that involves rewarding performances of desired behaviors and completion of tasks with tangible positive reinforcement (e.g., food, toys) paired with social praise. This therapist-directed instruction may be repeated over several days until the skill is mastered. These skills are then combined into more complex repertoires.
  • Pivotal response training is naturalistic behavioral intervention that is child-directed, and interventions are designed around materials or topics for which the individual expresses preference. Reinforcement is directly related to the task.
  • Incidental teaching is behaviorally based instruction where the interaction between adult and child occurs in the context of a natural situation where the child expresses an interest in something and the adult responds with prompts and praise.

Competency for behavior analyst practitioners to perform services related to ABA can be demonstrated through the completion of specialized training. Organizations offer voluntary credentialing programs for behavior analyst practitioners in an effort to provide consistent credentialing. For example, the Behavior Analyst Certification Board [BACB]), Inc. is a nonprofit 501(c)(3) corporation that was established in 1998 to meet professional credentialing needs identified by behavior analysts, governments and consumers of behavior analysis services. The BACB adheres to international standards for boards and grant professional credentials. The BACB certification procedures and content undergo regular psychometric review and validation, pursuant to a job analysis survey of the profession and standards established by content experts in the field. The Behavior Analyst Certification Board’s credentialing programs are accredited by the National Commission for Certifying Agencies (NCCA) in Washington, DC.

Applied Behavior Analysis is either provided by, or are under the supervision of, a certified ABA professional provider who is either a Board Certified Behavior Analyst-Doctoral (BCBA-D) or a Board Certified Behavior Analyst (BCBA)-graduate-level certification in behavior analysis. A BCBA-D and BCBA are professional providers who are independent practitioners who provide behavior analytic services and supervise the work of Board Certified Assistant Behavior Analysts, Registered Behavior Technicians, and others who provide behavior analytic interventions.

Functional behavioral assessment (FBA) is a technology grounded in the principles of ABA. Functional behavioral assessment is a process for identifying problem behaviors and developing interventions to improve or eliminate those behaviors, along with promoting more adaptive skills and behaviors. An FBA consists of information-gathering procedures that result in a hypothesis about the function(s) that the behavior is serving for the individual. The process also results in the identification of environmental antecedents and consequences that are maintaining the behavior. The information gathered is used to develop an effective and efficient treatment plan. Applied behavior analysis systematically applies behavioral intervention techniques coupled with a functional assessment of environmental factors to determine the relationship between the individual and their environment, to develop, maintain or restore the functioning of individuals with ASD.

Some methodologies to promote learning have also emerged, and, although they are not considered behavioral, they share common elements with behavioral methodologies. For example, the Treatment and Education of Autistic and Related Communication-Handicapped Children (TEACCH) model of structured teaching uses many forms of visual supports, such as picture schedules, to assist individuals with ASD. Another modality commonly used with individuals who have ASD is the developmental approach. Examples of the developmental approach include, but are not limited to, the Denver model (which focuses on intensive teaching and developing social communicative skills) and/or the developmental, individual-difference, relationship-based (DIR) floor-time model (which focuses on building emotional reciprocity). Despite the common use of such methodologies to promote learning, most have not been empirically validated.

Despite improvements in the quality of the published peer-reviewed literature on ABA, a current review of the available published peer-reviewed literature on ABA and other similar methodologies has revealed weaknesses in research design and analysis, as well as inconsistent results across studies, which undermine confidence in the reported results. Although it has been suggested that these methodologies may assist in the management of conditions associated with ASD, and many interventions including ABA have been endorsed by AAP, it is implicitly recognized that further high-quality studies are needed to determine the efficacy of these methodologies. Furthermore, substantial scientific advances are needed to enhance our understanding of which interventions are most effective for specific children with ASD and to isolate elements or components of interventions most associated with effects.

EDUCATIONAL SERVICES
Forming a therapeutic alliance of the parent(s) and/or caregiver(s), family members, and the school staff is the most crucial part of the treatment plan for children who are diagnosed with ASD. The treatment plan should include a realistic assessment of the available resources for the child. Educational services, including special education and some forms of behavior modification, are the central and essential aspects of treatment. Federal law 94-142, originally called the Education of All Handicapped Children Act (now known as the Individuals with Disabilities Education Act [IDEA]), mandates early intervention with appropriate developmental, therapeutic, and family support services for a child younger than three years of age with a known developmental disability or who demonstrates a developmental delay. When a child turns three years old, services shift so that school districts provide an appropriate plan of educational services (individualized educational plan [IEP]) for affected children. Education of family members and caregivers is essential in the management of ASD. Parents and/or caregivers should understand the child's developmental needs and develop practical strategies to meet their educational and social goals.

NEUROPSYCHOLOGICAL TESTING (NPT)
NPT consists of the administration of a series of standardized tests of differing mental functions and the interpretation of the findings so that inferences about brain function can be made. There is insufficient available published peer-reviewed literature to support standard use of NPT for individuals with ASD; however, NPT may be helpful in evaluating specific neurologic conditions that are present in an individual with suspected ASD.

ALTERNATIVE THERAPIES AND COMPLEMENTARY MEDICINE
Since ASD comprises chronic disorders that have no cure, parent(s) and/or caregiver(s) sometimes turn to alternative therapies and complementary medicine and/or therapies that are not traditionally used in the management of ASD. Alternative therapies and complementary medicine comprise a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. The following examples of alternative therapies and complementary medicine may be considered for the management of ASD:
  • Nutritional supplements
    Proponents of nutritional supplements claim that high doses of pyridoxine and magnesium have beneficial effects on the symptoms of ASD. However, studies have been criticized for their methodological shortcomings and failure to address the issue of safety of use.
  • Elimination diets
    Advocates of elimination diets have proposed that the selective absorption of ingested peptides caused by impaired bowel permeability can potentiate symptoms of ASD. This has led to the conclusion that the elimination of casein (the principal protein in milk) and gluten (a composite of proteins found in rye, wheat, and barley) from a child's diet would improve behavioral symptoms. To date, only a small number of children on elimination diets has been studied, and no control group was provided. The efficacy and safety of elimination diets have not been established; therefore, this therapy lacks validation.

OTHER THERAPIES/TREATMENTS FOR THE MANAGEMENT OF ASD
The following are examples of other therapies/treatments that have been introduced for the management of ASD:
  • Immune globulin therapy
    Immune globulin therapy (IVIg) focuses on immunological abnormalities, such as abnormalities of T- and B-cells (specialized defender cells that identify and destroy germs). Recent studies have failed to show significant improvement in ASD behavior when an affected individual was given IVIg therapy. At the present time, there is no scientific evidence to support the use of IVIg injections for the treatment of children with ASD.
  • Secretin
    Secretin is one of the hormones that controls digestion. The primary action of secretin is to increase the volume of bicarbonate content of secreted pancreatic juices. The use of secretin in the treatment of ASD comes from the theory that a link exists between gastrointestinal disorders and brain dysfunction. However, the available published literature does not support the use of secretin in the treatment of autism. In addition, the FDA has not approved the use of secretin in the treatment of autism.
  • Chelation therapy
    Intravenous (IV) chelation therapy is a method of removing toxic substances (e.g., lead, zinc, iron, copper, or calcium) from the body. Advocates of chelation therapy believe that ASD is caused by early childhood exposure to environmental toxicants, principally metals (particularly mercury in vaccines), and minerals. Studies have been unable to establish a connection between exposure to mercury and an incidence of ASD. Therefore, no data exists on the efficacy of chelation therapy for the treatment of ASD.
  • Auditory integration training (AIT)
    AIT is based on the unproven theory that ASD symptoms are caused by auditory perception defects. AIT consists of the identification of hypersensitivity and peak of sound distortion, as well as the selection of the optimum music for the individual. Once these determinations are made, the selected music is played twice a day for two weeks through a listening device such as the AudioKinetron. The data from the available studies on AIT showed no improvement in behavior, which led to the conclusion that AIT is not efficacious in the treatment of ASD.
  • Facilitative communication (FC)
    FC provides assistance to a nonverbal person in typing out words using a computer keyboard or other communication device. FC involves a trained facilitator supporting the individual's hand to help indicate which letters are necessary. Several scientific studies have suggested that facilitators unintentionally influence the communication, perhaps to the extent of actually selecting the words themselves. Reliable scientific data showing FC to be ineffective is available.

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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):1629-1635.

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):749-764.

Moeschler JB, Shevell M. Comprehensive evaluation of the child with intellectual disability or global developmental delays. Pediatrics.2014;134(3):903-918.

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National Institute of Child Health and Human Development (NICHD). Rett syndrome. [NICHD Web site]. 01/28/14. Available at: https://www.nichd.nih.gov/health/topics/rett. Accessed April 24, 2018.

National Institute of Mental Health (NIMH). Autism spectrum disorder. [NIMH Web site]. Available at: http://www.nimh.nih.gov/health/topics/autism-spectrum-disorders-asd/index.shtml Accessed April 24, 2018.

National Library of Medicine (NLM). Genetic Home Reference: Phosphatase and tensin homolog (PTEN). [NLM Web site]. 06/29/2015. Available at:http://ghr.nlm.nih.gov/gene/PTEN. Accessed April 24, 2018.

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Saam J, Gudgeon J, Aston E, et al. How physicians use array comparative genomic hybridization results to guide patient management in children with developmental delay. Genet Med.2008;10(3):181-186.

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Shaw-Smith C, Redon R, Rickman L, et al. Microarray based comparative genomic hybridization (array-CGH) detects submicroscopic chromosomal deletions and duplications in patients with learning disabilities/mental retardation and dysmorphic features. J Med Genet.2004;41(4):241-248.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY


0208T, 0209T, 0210T, 0211T, 0212T, 92002, 92004, 92012, 92014, 92507, 92508, 92521, 92522, 92523, 92524, 92526, 92552, 92553, 92555, 92556, 92557, 92585, 92586, 92587, 92588, 92610, 95812, 95813, 95816, 95819, 96110, 96112, 96113, 97110, 97112, 97116, 97127, 97139, 97150, 97151, 97152, 97153, 97154, 97155, 97156, 97157, 97158, 97161, 97162, 97163, 97164, 97165, 97166, 97167, 97168, 97530, 97533, 97535, 97537, 97750, 97755, 97799

THE FOLLOWING CODES ARE USED TO REPRESENT GENETIC TESTING TO IDENTIFY ASSOCIATED CONDITIONS OF ASD:

81228, 81229, 81243, 81244, 81302, 81303, 81304, 81321, 81322, 81323, 81331, 88245, 88248, 88249, 88261, 88262, 88263, 88264, 83655, 84030, 96040

COVERED WHEN A STATE MANDATE REQUIRES COVERAGE

THE FOLLOWING CODES ARE USED TO REPRESENT APPLIED BEHAVIOR ANALYSIS (ABA). PLEASE REFER TO THE CONTRACTED BEHAVIORAL HEALTH/MENTAL HEALTH VENDOR.

0362T, 0373T

NOT MEDICALLY NECESSARY

96132, 96133

NOT MEDICALLY NECESSARY WHEN USED TO REPORT NEUROPSYCHOLOGICAL TESTING

96136, 96137, 96138, 96139, 96146

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT AUDITORY INTEGRATION TRAINING (AIT):

97139

THE FOLLOWING CODE IS USED TO REPRESENT FACILITATIVE COMMUNICATION (FC):

97139

THE FOLLOWING CODE IS USED TO REPRESENT PANEL TESTING USING NEXT GENERATION SEQUENCING (NGS):

81479



Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

F84.0 Autistic disorder


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

G0515 Development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact, each 15 minutes

S0265 Genetic counseling, under physician supervision, each 15 minutes

S3870 Comparative genomic hybridization (cgh) microarray testing for developmental delay, autism spectrum disorder and/or intellectual disability

S9152 Speech therapy, re-evaluation


THE FOLLOWING CODES ARE USED TO REPRESENT APPLIED BEHAVIOR ANALYSIS (ABA). PLEASE REFER TO THE CONTRACTED BEHAVIORAL HEALTH/MENTAL HEALTH VENDOR.

G9012 Other specified case management service not elsewhere classified

H0031 Mental health assessment, by nonphysician

H0032 Mental health service plan development by nonphysician

H2014 Skills training and development, per 15 minutes

H2019 Therapeutic behavioral services, per 15 minutes

S5108 Home care training to home care client, per 15 minutes

S5110 Home care training, family; per 15 minutes


EXPERIMENTAL/INVESTIGATIONAL

J2850 Injection, secretin, synthetic, human, 1 mcg



Revenue Code Number(s)



0420 General classification for physical therapy

0421 Physical therapy visit charge

0422 Physical therapy hourly charge

0423 Physical therapy group rate

0424 Physical therapy evaluation and/or re-evaluation

0429 Other physical therapy services

0430 General classification for occupational therapy

0431 Occupational therapy visit charge

0432 Occupational therapy hourly charge

0433 Occupational therapy group rate

0434 Occupational therapy evaluation or re-evaluation

0439 Other occupational therapy services

0440 General classification for speech-language pathology

0441 Speech-language pathology charge by visit

0442 Speech-language pathology hourly charge

0443 Speech-language pathology group rate

0444 Speech-language pathology evaluation or re-evaluation

0449 Other speech-language pathology services

0979 Professional fees speech pathology



Misc Code

Modifier:


AF Speciality Physician

AH Clinical Psychologist

AJ Clinical Social Worker

HM Less than Bachelor Degree level

HN Bachelors Degree level

HO Masters Degree level

HP Doctoral Level

TD RN

UN 2 patients serviced

UP 3 patients serviced

UQ 4 patients serviced

UR 5 patients serviced

US 6 or more patients serviced



Coding and Billing Requirements


Cross References


Policy History

07.03.07r
01/01/2019This policy has been identified for the CPT, HCPCS code update, effective 01/01/2019.

The following CPT codes have been deleted from this policy:

0359T, 0360T, 0361T, 0363T, 0364T, 0365T, 0366T, 0367T, 0368T, 0369T, 0370T, 0371T, 0372T,0374T, 96111, 96118, 96119, 96120

The following CPT codes have been added to this policy:

96112, 96113, 96121, 96130, 96131, 96132, 96133, 96136, 96137, 96138, 96139, 96146, 97151, 97152, 97153, 97154, 97155, 97156, 97157, 97158

The following CPT codes have been revised in this policy:

0362T, 0373T, 81244

______________________________________

Note: on 03/25/2019 the following CPT codes were deleted from this policy: 96121,96130, 96131. These codes were added to this policy in error as part of the 01/01/2019 CPT/HCPCS code update. Retroactively effective to 01/01/2019, these codes have been deemed inappropriate for the purposes of this policy. An additional NOT MEDICALLY NECESSARY header has been added to the CPT section of the coding table.

07.03.07q
06/06/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Evaluation and Management of Autism Spectrum Disorders (ASD).
01/01/2018This policy has been identified for the CPT, HCPCS code update, effective 01/01/2018.

The following CPT code has been termed from this policy:

97532 Development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact, each 15 minutes

The following CPT code has been added to this policy:

97127 Therapeutic interventions that focus on cognitive function (eg, attention, memory, reasoning, executive function, problem solving, and/or pragmatic functioning) and compensatory strategies to manage the performance of an activity (eg, managing time or schedules, initiating, organizing and sequencing tasks), direct (one-on-one) patient contact

The following HCPCS code has been added to this policy:

G0515 Development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact, each 15 minutes


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/02/2019
Version Reissued Date: N/A

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