Coverage Policy Manual
Policy #: 2003043
Category: Medicine
Initiated: July 2003
Last Review: April 2024
  Sensory Integration Therapy and Auditory Integration Therapy
Description:
The goal of SI therapy is to improve the way the brain processes and adapts to sensory information, as opposed to teaching specific skills. Therapy usually involves activities that provide vestibular, proprioceptive, and tactile stimuli, which are selected to match specific sensory processing deficits of the child. For example, swings are commonly used to incorporate vestibular input, while trapeze bars and large foam pillows or mats may be used to stimulate somatosensory pathways of proprioception and deep touch. Tactile reception may be addressed through a variety of activities and surface textures involving light touch.
  
Auditory integration therapy (also known as auditory integration training, auditory enhancement training, audio-psycho-phonology) involves having individuals listen to music modified to remove frequencies to which they are hypersensitive, with the goal of gradually increasing exposure to sensitive frequencies. Although several methods of auditory integration therapy have been developed, the most widely described is the Berard method, which involves 2 half-hour sessions per day separated by at least 3 hours, over 10 consecutive days, during which patients listen to recordings. Auditory integration therapy has been proposed for individuals with a range of developmental and behavioral disorders, including learning disabilities, autism spectrum disorder, pervasive developmental disorder, and attention-deficit/hyperactivity disorder. Other methods include the Tomatis method, which involves listening to electronically modified music and speech, and Samonas Sound Therapy, which involves listening to filtered music, voices, and nature sounds (Sinha, 2011).
 
Regulatory Status
SI therapy is a procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration (FDA). There are no devices designed to provide AI therapy that have clearance for marketing from FDA.
Policy/
Coverage:
Effective January 2014
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Sensory integration therapy and auditory integration therapy do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, sensory integration therapy and auditory integration therapy are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to January 2014
 
Sensory integration therapy does not meet member benefit certificate primary coverage criteria, which excludes services for which there is no peer reviewed medical literature that establishes effectiveness.
 
For contracts without primary coverage criteria, sensory integration therapy is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
Rationale:
Systematic Reviews
Case-Smith and Arbesman reviewed the evidence for SI therapy as part of a systematic review of interventions for autism used in occupational therapy in 2008 (Case-Smith, 2008). The authors identified one level-1 study, which was a systematic review from 2002 that had found only lower quality evidence (levels III and IV, with small sample size and lack of control groups), suggesting that SI intervention was associated with positive changes in social interaction, purposeful play, and decreased sensitivity (Baranek, 2002). It was concluded that “although each of these studies had positive findings, when combined, the evidence remains weak and requires further study.”
 
May-Benson and Koomar published a systematic review of SI therapy in 2010 (May-Benson, 2010).  The review identified 27 research studies (13 level-I randomized trials) that met the inclusion criteria. Most of the studies had been performed in children with learning or reading disabilities; there were 2 case reports/small series on the effect of SI therapy in children with autism. The review concluded that although the SI approach may result in positive outcomes, findings may be limited because of small sample sizes, variable intervention dosage, lack of fidelity to intervention, and selection of outcomes that may not be meaningful or may not change with the treatment provided.
 
A 2011 Cochrane review evaluated auditory integration training along with other sound therapies for autism spectrum disorders (Sinha, 2011). Included were 6 randomized controlled trials of auditory integration therapy and one of Tomatis therapy, involving a total of 182 subjects aged 3 to 39 years. For most of the studies, the control condition consisted of listening to unmodified music for the same time as the active treatment group. Allocation concealment was inadequate for all studies, and 5 of the trials had fewer than 20 participants. Meta-analysis could not be conducted. Three studies did not demonstrate any benefit of auditory integration therapy over control conditions, and 3 studies had outcomes of questionable validity or outcomes that did not achieve statistical significance. The review found no evidence that auditory integration therapy is an effective treatment for autism spectrum disorders; however, evidence was not sufficient to prove that it is not effective.
 
Controlled Trials
The Sensory Processing Disorders Scientific Workgroup has discussed the methodologic challenges of conducting intervention effectiveness studies of dynamic interactional processes, the lack of scientific evidence to support current practice, and methods for improving the quality of research in this area (Mailloux, 2007; Parham, 2007). In 2007, members of the workgroup also reported results from a single institution randomized pilot study for a proposed multicenter trial (Miller, 2007). Thirty families (of approximately 140 who met the inclusion/exclusion criteria) agreed to participate over a 3-year period. The children had a clinical diagnosis of sensory modulation disorder following a comprehensive evaluation with standardized and clinical testing (including responses to sensory stimuli, attempts by the child to self-regulate, behavioral disorganization, and somatic responses to the testing situations). The 24 children who began treatment were randomly assigned to 1 of 3 groups consisting of occupational therapy with SI (2 times per week for 10 weeks, n=7), equivalent activity control sessions (n=10), or a waiting-list control group (n=7). Functional improvements were assessed by 5 validated/standardized parental rating scales. Significant improvements relative to both control groups were obtained for Goal Attainment Scaling (37 vs. 14 vs. 7, consecutively). A number of the other outcome measures (Leitner International Performance Scale, Short Sensory Profile, Internalizing on the Child Behavior Checklist) showed trends for improvement in this small study. Additional study with a larger number of subjects is needed.
 
Another pilot study, reported in 2011, randomized 37 children with a sensory processing disorder (21 with autism and 16 with pervasive developmental disorder not otherwise specified) to SI interventions or to fine motor interventions (18 treatments over 6 weeks) (Pfeiffer, 2011). Fidelity to SI interventions was verified with a fidelity measure developed for research by Parham et al. (Parham, 2007) Blinded evaluation at the conclusion of the intervention found no significant difference between the 2 groups on the Quick Neurological Screening Test (QNST) or sensory processing scores except for Autistic Mannerisms (e.g., stereotyped or self-stimulatory behavior) subscale. The SI group demonstrated greater improvement than the fine motor group on individualized Goal Attainment Scaling. Post-hoc analysis found that more children in the SI group were able to complete parts of the standardized QNST after the intervention. This finding is limited by the post-hoc analysis and the difference in the 2 groups at baseline.
 
In a 2003 study of 45 children with Down’s syndrome divided into 3 treatment groups (sensory integrative therapy alone, vestibular stimulation combined with sensory integrative therapy, and neurodevelopmental therapy), Uyanik and colleagues reported greater improvements in outcomes in the vestibular stimulation with SI therapy group and in the neurodevelopmental therapy group when compared to the SI therapy alone group (Uyanik, 2003). Outcomes assessed were the Ayres Southern California Sensory Integration Test, Pivot Prone Test, Gravitational Insecurity Test, and Pegboard Test along with physical assessment. The authors concluded all methods of treatment should be considered when planning rehabilitation therapies for children with Down’s syndrome, even though sensory integrative therapy alone was not shown to be superior to the other therapy groups.
 
Summary
Overall, the evidence remains insufficient to evaluate the effect of this treatment on health outcomes. As noted by Kratz, “there exists very little research that supports the effectiveness of any intervention for children with chronic or mild disabilities across all disciplines” (Kratz, 2009). Due to the individual nature of SI therapy and the large variation in individual therapists and patients, large multicenter randomized controlled trials are needed to evaluate the efficacy of this intervention.
 
Practice Guidelines and Position Statements
The American Academy of Pediatrics (AAP) stated in 2007 guidance that “the efficacy of SI [sensory integration] therapy has not been demonstrated objectively” (Myers, 2007). The guidance document on management of children autism spectrum disorders is available online at: http://pediatrics.aappublications.org/cgi/reprint/peds.2007-2362v1. A 2012 policy statement by the AAP on SI therapies for children with developmental and behavioral disorders states that “occupational therapy with the use of sensory-based therapies may be acceptable as one of the components of a comprehensive treatment plan. However, parents should be informed that the amount of research regarding the effectiveness of sensory integration therapy is limited and inconclusive.” The AAP indicates that these limitations should be discussed with parents, along with instruction on how to evaluate the effectiveness of a trial period of SI therapy (Zimmer, 2012).
 
In 2009, the American Occupational Therapy Association (AOTA) stated that the AOTA recognizes sensory integration (SI) as one of several theories and methods used by occupational therapists and occupational therapy assistants working with children in public and private schools to improve a child’s ability to access the general education curriculum and to participate in school-related activities (Roley, 2009). In 2011, the AOTA published evidence-based occupational therapy practice guidelines for children and adolescents with challenges in sensory processing and sensory integration (Watling, 2011).  AOTA gave a level C recommendation for sensory integration therapy for individual functional goals for children, for parent-centered goals, and for participation in active play in children with sensory processing disorder, and to address play skills and engagement in children with autism. A level C recommendation is based on weak evidence that the intervention can improve outcomes, and the balance of the benefits and harms may result either in a recommendation that occupational therapy practitioners routinely provide the intervention or in no recommendation because the balance of the benefits and harms is too close to justify a general recommendation. Specific performance skills evaluated were motor and praxis skills, sensory-perceptual skills, emotional regulation, and communication and social skills. There was insufficient evidence to provide a recommendation on sensory integration for academic and psychoeducational performance (e.g., math, reading, written performance).
 
2014 Update
A literature search conducted through May 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
This update focuses on literature assessing the use of auditory integration therapy. The policy previously addressed only sensory integration therapy. The coverage statement has been changed to address auditory integration therapy based on review of the following key identified literature.
 
Auditory Integration Therapy
Although auditory integration (AI) therapy has been proposed as a therapy for a number of neurobehavioral disorders, the largest body of evidence on AI therapy relates to its use in ASD. Several systematic reviews have evaluated the evidence related to AI therapy for ASDs. A 2011 Cochrane review evaluated AI training along with other sound therapies for ASDs (Sinha, 2011). Included were 6 RCTs of AI therapy and one of Tomatis therapy, involving a total of 182 subjects aged 3 to 39 years. For most of the studies, the control condition consisted of listening to unmodified music for the same time as the active treatment group. Allocation concealment was inadequate for all studies, and 5 of the trials had fewer than 20 participants. Meta-analysis could not be conducted. Three studies did not demonstrate any benefit of AI therapy over control conditions, and 3 studies had outcomes of questionable validity or outcomes that did not achieve statistical significance. The review found no evidence that AI therapy is an effective treatment for ASDs; however, evidence was not sufficient to prove that it is not effective.
 
A 2010 systematic review of therapies for autism evaluated the evidence for AI training in the treatment of Autism (Parr, 2010).  The author identified a 2002 systematic review (an early version of the 2011 Cochrane review by Sinha et al previously referenced), which identified no RCTs meeting the author’s inclusion criteria, and no subsequent RCTs or cohort studies comparing AI therapy with usual care.
 
In 2009, Rossignol conducted a systematic review of novel and emerging treatments for ASDs, including AI therapy (Rossignol, 2009). The authors identified one 3-month, double-blind, controlled study of AI therapy in 17 individuals with autism, which demonstrated significant improvements in irritability, stereotypy, hyperactivity, and excessive speech in patients in the therapy group. The study also reviewed an earlier version of the 2011 Cochrane review by Sinha et al previously referenced. Overall, the authors concluded that there was grade C evidence related to the use of AI therapy in autism (at least 1 level 2b [individual prospective, nonrandomized cohort study or low-quality RCT] or 3b [systematic review of retrospective case-control studies with homogeneity] studies OR 2 level 4 studies [case series or reports]).
 
Section Summary
The largest body of evidence related to the use of AI therapy is in the treatment of autism. A 2011 Cochrane review and several earlier systematic reviews generally found that studies of AI therapy failed to demonstrate meaningful clinical improvements. No subsequent comparative studies of AI therapy were identified.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in September 2014 identified no ongoing trials of SI or AI therapy.
 
Summary of Evidence
Due to the individual nature of sensory integration (SI) therapy and the large variation in individual therapists and patients, large multicenter randomized controlled trials are needed to evaluate the efficacy of this intervention. The most direct evidence related to outcomes from SI therapy comes from small randomized trials. Although some of the studies demonstrated some improvements on subsets of the outcomes measured, the studies are limited by small sizes, heterogeneous patient populations, and variable outcome measures. As a result, the evidence is insufficient to draw conclusions about the effects of and the most appropriate patient populations for SI therapy.
 
For auditory integration (AI) therapy, the largest body of literature relates to its use in autism. Several systematic reviews of AI therapy in the treatment of autism found limited evidence to support its use. No comparative studies were identified that evaluated the use of AI therapy for other conditions.
 
Practice Guidelines and Position Statements
 
SI Therapy
The American Academy of Pediatrics (AAP) stated in 2007 guidance that “the efficacy of SI [sensory integration] therapy has not been demonstrated objectively” (Myers, 2007).
 
A 2012 policy statement by AAP on SI therapies for children with developmental and behavioral disorders states that “occupational therapy with the use of sensory-based therapies may be acceptable as one of the components of a comprehensive treatment plan. However, parents should be informed that the amount of research regarding the effectiveness of sensory integration therapy is limited and inconclusive.” AAP indicates that these limitations should be discussed with parents, along with instruction on how to evaluate the effectiveness of a trial period of SI therapy (Zimmer, 2012).
 
In 2009, the American Occupational Therapy Association (AOTA) stated that AOTA recognizes SI as one of several theories and methods used by occupational therapists and occupational therapy assistants working with children in public and private schools to improve a child’s ability to access the general education curriculum and to participate in school-related activities (Roley, 2009). In 2011, AOTA published evidence-based occupational therapy practice guidelines for children and adolescents with challenges in sensory processing and sensory integration (Watling, 2011). AOTA gave a level C recommendation for SI therapy for individual functional goals for children, for parent-centered goals, and for participation in active play in children with sensory processing disorder, and to address play skills and engagement in children with autism. A level C recommendation is based on weak evidence that the intervention can improve outcomes, and the balance of the benefits and harms may result either in a recommendation that occupational therapy practitioners routinely provide the intervention or in no recommendation because the balance of the benefits and harms is too close to justify a general recommendation. Specific performance skills evaluated were motor and praxis skills, sensory-perceptual skills, emotional regulation, and communication and social skills. There was insufficient evidence to provide a recommendation on sensory integration for academic and psychoeducational performance (eg, math, reading, written performance).
 
AI Therapy
In 2003, the American Speech-Language-Hearing Association (ASHA) Working Group on Auditory Integration Training issued a report on Auditory Integration Training (Association AS-L-H, 2004). The review concluded that “Despite approximately one decade of practice in this country, this method has not met scientific standards for efficacy and safety that would justify its inclusion as a mainstream treatment for these disorders.”
 
In 1998, the AAP Committee on Children with Disabilities issued a statement on AI training and facilitated communication for autism, which concluded, “Currently available information does not support the claims of proponents that these treatments are efficacious. Their use does not appear warranted at this time, except within research protocols” (Disabilities CoCW, 1998).
 
 
2016 Update
A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through December 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2015, Brondino and colleagues published a systematic review of complementary and alternative therapies for autism, which included SIT and auditory integration therapy (AIT) (Brodino, 2015).  Regarding SIT for autism treatment, the authors identified 4 trials, including the RCT reported by Pfeiffer et al (described below), and additional studies published in 1983, 2008, and 2011, with sample sizes of 18, 30, and 50, respectively. All 4 studies reported significant improvements in autistic core symptoms, including communication, social reciprocity, and motor activity. However, the reviewers noted that 2 studies did not use a standardized form of SIT, and 2 did not use standardized outcome measures.
 
Watling and Hauer published a systematic review of Ayres Sensory Integration (ASI) and sensory-based interventions for individuals with ASD (Watling, Hauer. 2015) The authors describe ASI as a play-based method that “uses active engagement in sensory-rich activities to elicit the child’s adaptive responses and  improve the child’s ability to successfully perform and meet environmental challenges.” The therapy is individualized by the therapist in response to an initial assessment. Sensory-based interventions are described as “applying adult-directed sensory modalities to the child with the aim of producing a short-term effect on self-regulation, attention, or behavioral organization.” Twenty-three articles met the authors’ inclusion criteria, 3 of which were systematic reviews and 5 of which were RCTs. Overall, 4 studies evaluated ASI and the remaining 18 evaluated sensory-based interventions. Of the 4 studies evaluating ASI, 3 were RCTs, including the studies by Pfeiffer et al and Schaaf et al described below. Findings from 1 RCT included significant improvement in individualized goals, improved sleep, decreased autism mannerisms, and reduced caregiver burden.
 
2018 Update
A literature search conducted using the MEDLINE database did not reveal any new information that would prompt a change in the coverage status.
 
2019 Update
A literature search was conducted through December 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2020 Update
A literature search was conducted through December 2019.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The 2015 American Occupational Therapy Association (AOTA) guidelines stated: “American Occupational Therapy Association (AOTA) recognizes sensory integration as one of several theories and methods used by occupational therapists and occupational therapy assistants working with children in public and private schools...to “enhance a person’s ability to participate in life through engagement in everyday activities….When children demonstrate sensory, motor, or praxis deficits that interfere with their ability to access the general education curriculum, occupational therapy using an sensory integration approach is appropriate.” (AOTA, 2015)
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In a systematic review conducted for the Agency for Healthcare Research and Quality (AHRQ), Weitlauf et al evaluated the effectiveness and safety of a variety of interventions targeting sensory challenges in ASD (Weitlauf, 2017). The reviewers included 3 RCTs and 1 retrospective cohort study of sensory integration-based approaches, defined as interventions using combinations of sensory and kinetic components, such as materials with different textures, touch/massage, swinging and trampoline exercises, and balance and muscle resistance exercises. One study was rated low risk of bias, 1 moderate, and 2 high risk of bias. Significant heterogeneity across studies in interventions and outcome measures precluded meta-analysis. In 3 of 4 studies, sensory-related measures and motor skills measures improved for children receiving the sensory integration-based intervention, however the strength of this evidence was rated low due to small sample sizes and short study durations. The studies were also limited by a lack of blinding when parent-reported outcome measures were used. The reviewers concluded, "Although some therapies may hold promise and warrant additional study, substantial needs exist for continuing improvements in methodologic rigor in the field."
 
In their systematic review of sensory interventions conducted for AHRQ, Weitlauf et al (2017) included 4 RCTs of auditory integration therapy (Weitlauf, 2017). Two small, short-term RCTs with moderate risk of bias reported no significant differences between auditory integration and control groups in language outcomes assessed on parent, teacher, and clinician observation measures (Corbett, 2008; Mudford, 2000). Two other RCTs, reported in a single publication, reported some parent-rated improvement in hearing sensitivity, spontaneous speech, listening, and behavioral organization, but no difference in other behavioral domains rated (Porges, 2014). Overall, the reviewers concluded that there is low strength evidence that auditory integration-based approaches do not improve language outcomes.
 
In 2002, the American Speech-Language-Hearing Association Work Group on Auditory Integration Therapy concluded that auditory integration therapy has not met scientific standards for efficacy that would justify its practice by audiologists and speech-language pathologists (ASHA, 2004).
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The SENsory Integration Therapy for sensory processing difficulties in children with Autism spectrum disorder (SenITA) RCT was funded by the National Institute for Health and Care Research (UK) and reported by Randell et al (Randell, 2022)., A total of 138 children ages 4 to 11 years with an autism diagnosis or sensory processing difficulties were randomized to Ayres Sensory Integration® therapy delivered in 26 1-hour sessions over 26 weeks (intensive phase), followed by 2 sessions per month for 2 months and then 1 telephone session per month for 2 months (tailoring phase). The comparator was usual care, which was defined as awaiting services or receiving sensory-based intervention not meeting fidelity criteria for sensory integration. Outcomes were measured at 6 and 12 months post randomization. The primary outcome was irritability/agitation (as measured by the corresponding Aberrant Behavior Checklist subscale), indicative of challenging behavior, at 6 months. Secondary outcomes included other problem behaviors, adaptive behaviors and functioning, socialization, caregiver stress, and quality of life. Outcome assessors were blinded to treatment allocation.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
97533Sensory integrative techniques to enhance sensory processing and promote adaptive responses to environmental demands, direct (one on one) patient contact, each 15 minutes
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