Subject: Speech Therapy for Autism Spectrum Disorder Effective Date: Guidance Number: MCG-056 Revision Date(s): 10/26/11, 6/12/14

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1 Subject: Speech Therapy for Autism Spectrum Disorder Original Effective Date: Guidance Number: MCG-056 Revision Date(s): 10/26/11, 6/12/14 Medical Coverage 6/12/14 Guidance Approval Date: 11/20/08 PREFACE This Medical Guidance is intended to facilitate the Utilization Management process. It expresses Molina's determination as to whether certain services or supplies are medically necessary, experimental, investigational, or cosmetic for purposes of determining appropriateness of payment. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (i.e., will be paid for by Molina) for a parti cular member. The member's benefit plan determines coverage. Each benefit plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers will need to consult the member's benefit plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a State, the Federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website: FDA INDICATIONS Speech therapy programs are procedures and are not subject to FDA regulation. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS) The coverage directive(s) and criteria from an existing National Coverage Determination (NCD) or Local Coverage Determination (LCD) will supersede the contents of this Molina medical coverage guidance (MCG) document and provide the directive for all Medicare members. The directives from this MCG document may be followed if there are no available NCD or LCD documents available and outlined below. A National Coverage Determination (NCD) is not currently available for speech therapy for autism spectrum disorder. Coverage determinations are left to the discretion of local Medicare carriers in the absence of an NCD. INITIAL COVERAGE CRITERIA Molina Healthcare Inc. considers speech-language therapy for autism spectrum disorder unproven as there is insufficient scientific evidence from randomized controlled trials indicating that speech-language therapy benefits children who have autism spectrum disorder. COVERAGE EXCLUSIONS Speech-language therapy for autism spectrum disorder is considered unproven as there is insufficient scientific evidence from randomized controlled trials indicating that speech-language therapy benefits children who have autism spectrum disorders. Page 1 of 8

2 DESCRIPTION OF PROCEDURE/SERVICE/PHARMACEUTICAL Autism spectrum disorder is a range of complex disorders that historically were referred to as pervasive developmental disorders which are a biologically based neurodevelopmental disorders characterized by impairments in two major domains: deficits in social communication and social interaction and restricted repetitive patterns of behavior, interests, and activities. These symptoms are present from early childhood and limit or impair everyday functioning. Manifestations of the disorder vary greatly depending on the severity of the autistic condition, developmental level, and chronological age, which leads to the term spectrum. The DSM- 5 diagnosis of ASD includes disorders previously known as autistic disorder (classic autism, sometimes called early infantile autism, childhood autism, or Kanner's autism), childhood disintegrative disorder, pervasive developmental disorder-not otherwise specified, and Asperger disorder (also known as Asperger syndrome). The pathogenesis of autism spectrum disorder (ASD) is incompletely understood. The general consensus is that ASD has a genetic etiology, which alters brain development, affecting social and communication development and leading to restricted interests and repetitive behavior The new DSM-5 diagnostic criteria have been rearranged into two areas: 1) social communication/interaction, and 2) restricted and repetitive behaviors. The diagnosis will be based on symptoms, currently or by history, in these two areas. Symptoms must be present in early childhood but may not become fully manifest until social demands exceed capacities, must be functionally impairing and not better described by another DSM-5 diagnosis. 16 Many different speech and language therapies have been developed to promote verbal and nonverbal communication in children who have ASD. The Denver Model approach relies on social games, imitation, simple instructions, object associations, and verbal approximations of target words to cultivate language acquisition. Parents observe individual treatment sessions and provide daily review and reinforcement at home. In contrast, the Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) approach places more emphasis on the mechanics of speech. For example, therapy sessions are designed to elicit a verbal response that is gradually molded to match words to objects through therapist manipulation of patient jaw and lips along with visual and auditory cues. Other approaches involve imitation with animation, expectant waiting, activities to promote social interactions, or exchange of pictures as a means of establishing communication that transition into speech. Speech-language therapy is typically provided by speech-language therapists or speech-language pathologists in outpatient clinics or special education classrooms with training of parents to provide reinforcement at home. 4 GENERAL INFORMATION Summary of Medical Evidence Lounds et al. (AHRQ 2012) conducted a systematic review of the evidence on therapies for adolescents and young adults (ages 13 to 30) with autism spectrum disorders (ASD). This review focused on the outcomes, including harms and adverse effects, of interventions addressing the core symptoms of ASD; common medical and mental health comorbidities occurring with ASD; the attainment of goals toward functional/adult independence; educational and occupational/vocational attainment; quality of life; access to health and other Page 2 of 8

3 services; and the transitioning process (i.e., process of transitioning to greater independent functioning). 32 studies were identified, most of which were poor quality. Five studies, mostly of medical interventions, were fair quality, and none were good. In the behavioral literature, studies of group- and computer-based interventions reported short-term gains in social skills. Two poor-quality studies of educational interventions reported some gains in vocabulary and reading. Four small studies investigated disparate interventions addressing highly specific adaptive/life skills with some positive results in studies typically of short duration. Studies of vocational interventions, all of poor quality, reported that on-the job supports may promote employment in the community. Little evidence supports the use of medical interventions in adolescents and young adults with ASD; however, antipsychotic medications and serotonin reuptake inhibitors were associated with improvements in specific challenging behaviors. Similarly, little evidence supports the use of allied health interventions including facilitated communication. The review concluded that few studies have been conducted to assess treatment approaches for adolescents and young adults with ASD, and as such there is very little evidence available for specific treatment approaches in this population; this is especially the case for evidencebased approaches to support the transition of youth with autism to adulthood. 18 Warren et al (AHRQ 2011) systematically reviewed the evidence on therapies for children ages 2 to 12 with autism spectrum disorders (ASDs). This review focused on treatment outcomes, modifiers of treatment effectiveness, evidence for generalization of outcomes to other contexts, and evidence to support treatment decisions in children ages 0 2 at risk for an ASD diagnosis. Of the 159 studies reviewed, 13 were good quality, 56 were fair, and 90 were poor. Medical interventions including risperidone and aripiprazole show benefit for reducing challenging behaviors in some children with ASDs, but side effects are significant. Some behavioral and educational interventions that vary widely in terms of scope, target, and intensity have demonstrated effects, but the lack of consistent data limits our understanding of whether these interventions are linked to specific clinically meaningful changes in functioning. The review concluded that there are needs for continuing improvements in methodologic rigor in the field and for larger multisite studies of existing interventions are substantial. Better characterization of children in these studies to target treatment plans is imperative. Adams et al. (2012) conducted a randomized controlled trial of the effectiveness of speech and language therapy for school-age children who have pragmatic and social communication problems with or without autism spectrum disorder. Children who show disproportionate difficulty with the pragmatic as compared with the structural aspects of language are described as having pragmatic language impairment (PLI) or social communication disorder (SCD). Some children who have PLI also show mild social impairments associated with high-functioning autism or autism spectrum disorder (ASD). In a single-blind RCT design, 88 children with pragmatic and social communication needs aged 5;11-10;8, recruited from UK speech and language therapy services, were randomly assigned in a 2:1 ratio to SCIP or to treatment-as-usual. Children in the social communication intervention (SCIP) condition received up to 20 sessions of direct intervention from a specialist research speech and language therapist working with supervised assistants. No significant treatment effect was found for the primary outcome measure of structural language ability or for a measure of narrative ability. The authors concluded that there is some evidence of an intervention effect on blind and parent/teacher-reported communication outcomes, but not standardized language assessment outcomes, for 6-11-year-old children who Page 3 of 8

4 have pragmatic and social communication needs. The substantial overlap between the presence of PLI and ASD (75%) across the whole cohort suggests that the intervention may also be applicable to some verbally able children with ASD who have pragmatic communication needs. 20 A large randomized controlled trial of speech therapy for ASD was a performed by Yoder and Stone and described in two articles A total of 36 children (33 with autism, 3 with PDD-not otherwise specified) were randomly assigned to therapy using the Picture Exchange Communication System (PECS), a method of communication that relies on exchanging pictures combined with verbal prompts, or Responsive Education and Prelinguistic Milieu Teaching (RPMT), which involves requesting, commenting, and taking turns during play routines. Although mean chronological age of the children was 34 ± 8 months, mean verbal age was 12 ± 3 months. Children underwent a mean of sixty 20-minute sessions of assigned therapy over the course of 6 months and parents were offered 15 hours of training in the assigned therapy to reinforce lessons at home. For both groups combined, mean frequency of nonimitative spoken acts per 15-minute session increased from 0.25 ± 0.84 at baseline to 5.5 ± 10.4 at 6 months follow-up, a statistically significant difference (P=0.005). Likewise, mean frequency of different nonimitative words per 15-minute session increased from 0.17 ± 0.56 to 3.0 ± 5.8 (P=0.001). After completion of therapy sessions, the PECS Group had better scores than the RPMT Group in both measures (P<0.05); however, at 6 months follow-up, there were no statistically significant differences between the groups in either outcome measure. For the between-group comparisons, post-treatment and followup outcomes were adjusted for all statistically significant differences observed at baseline. During the treatment phase of the study, children underwent a mean of 17 ± 23 hours of other types of therapy per month including 7 ± 4 hours of speech-language therapy. This external therapy increased to 34 ± 39 hours per month with 9 ± 6 hours of speech-language therapy during follow-up. Participation in external therapies makes it impossible to determine the absolute effectiveness of RPMT and PECS therapies; however, analysis of their relative effectiveness indicated that initial improvement with PECS was more rapid for children who showed a higher tendency to explore new objects (P<0.05). Further analysis indicated that RPMT treatment was associated with greater improvements in turn-taking and initiating joint attention whereas PECS was associated with greater improvements in making generalized requests. 14 UpToDate UpToDate has several reviews on the topic of diagnosis and treatment of autism spectrum disorder Professional Organizations The American Academy of Pediatrics (AAP) has published a policy statement (2007, reaffirmed 2010) for the management of children with autism spectrum disorder. The statement indicates educational interventions, including behavioral strategies and habilitative therapies, are the cornerstones of management of ASD s. These interventions address communication, social skills, daily-living skills, play and leisure skills, academic Page 4 of 8

5 achievement, and maladaptive behaviors. The AAP also mentions that speech therapy is less effective when it 6 23 is not integrated with other interventions (i.e.; Applied Behavior Analysis therapy). The National Institute for Neurological Disorders and Stroke indicate that PDD does not have a cure. They state Some children with PDD benefit from specialized classrooms in which the class size is small and instruction is given on a one-to-one basis. Others function well in standard special education classes or regular classes with additional support. Early intervention including appropriate and specialized educational programs and support services plays a critical role in improving the outcome of individuals with PDD. 4 The autism fact sheet from this organization indicates there are a number of controversial therapies or interventions available for autistic children, but few, if any, are supported by scientific studies. Parents should use caution before adopting any of these treatments. 8 The National Institute of Mental Health (NIMH) states that While there's no proven cure yet for autism spectrum disorder (ASD), treating ASD early, using school-based programs, and getting proper medical care can greatly reduce ASD symptoms and increase your child's ability to grow and learn new skills. 7 State Resources Each state has special programs available for special education and related services. The Individuals with Disabilities Act (IDEA) is a federally mandated program that provides free and appropriate public education for children with diagnosed learning disabilities. Public school districts pay for the necessary services. These services include social workers, speech therapists, occupational therapists, school nurse, aide and school psychologist. An individualized Education Program (IEP) is a list of goals agreed upon by the family and the school. An annual meeting is scheduled with the family to review progress and to adjust the plan. An early intervention program is available within each state for children under the age of three. These services are typically provided by a state contracted program for toddlers with disabilities. Services may be provided in the home or at another designated place. The plan of care is reviewed every 6 months. Early intervention programs will target learning deficits, attention, motivation, compliance, imitation, early communication and social interaction skills. Children older than 3 years typically have school-based individualized, special education. Teachers typically involve parents on how to help their child incorporate skills or behaviors learned at school. Many elementary schools now have an inclusion program. The child remains within a regular classroom, for most of the day, and receives special instruction for part of the day. A child with a disability may not be eligible for special education and related services. The child s disability must adversely affect his or her educational performance to be determined eligible. Page 5 of 8

6 CODING INFORMATION CPT Description Evaluation of speech, language, voice, communication, and/or auditory processing Treatment of speech, language, voice, communication, and/or auditory processing disorder; individual Treatment of speech, language, voice, communication, and/or auditory processing disorder; group, 2 or more individuals Evaluation of speech sound production (eg, articulation, phonological process, apraxia, dysarthria); Evaluation of speech sound production (eg, articulation, phonological process, apraxia, dysarthria); with evaluation of language comprehension and expression (eg, receptive and expressive language) HCPCS Description G0153 Services of a speech and language pathologist in home health or hospice settings, each 15 minutes G0161 S9128 S9152 Services performed by a qualified speech-language pathologist, in the home health setting, in the establishment or delivery of a safe and effective speech-language pathology maintenance program, each 15 minutes Speech therapy, in the home, per diem Speech therapy, reevaluation ICD Description Pervasive developmental disorders ICD-10 Description F84.0 Autistic disorder F84.3 Other childhood disintegrative disorder F84.5 Aspergers syndrome F84.8 Other pervasive developmental disorders F84.9 Pervasive developmental disorder unspec RESOURCE REFERENCES 1. Augustyn M, Parker S, Fishman M, Torchia M. Clinical features of autism spectrum disorders. In: UpToDate, Rose, BD (ed), UpToDate, Waltham, MA. April, 2014 Page 6 of 8

7 2. Centers for Medicare & Medicaid Services. National Coverage Determinations (NCD s) Accessed at : 3. Hayes Health Technology Brief. Speech Therapy for pervasive developmental disorders. Winifred Hayes Inc. Lansdale, PA. April 28, Last review April 13, Archived May 28, National Institute for Neurological Disorders and Stroke. NINDS Pervasive Developmental Disorders Information Page. Last updated April, Accessed at: 5. Millar DC, Light JC, Sclosser RW. The impact of augmentative and alternative communication intervention on the speech production of individuals with developmental disabilities: a research review. Journal Speech Language Hearing Research, 2006 April;49(2): Myers SM, Johnson CP for the Council on Children with Disabilities. Management of children with autism spectrum disorders. American Academy of Pediatrics. November, 2007;120(5): National Institutes of Mental Health. Autism Spectrum Disorders. Accessed at: 8. National Institute of Neurological Disorders and Stroke. Autism fact sheet. Dec, Accessed at: 9. Augustyn M, Parker S, Fishman M, Torchia M. Terminology, epidemiology, and pathogenesis of autism spectrum disorders. In: UpToDate, Rose, BD (ed), UpToDate, Waltham, MA. April, Baron-Cohen S. Two new theories of autism: hyper-systemizing and assortative mating. Arch Dis Child.2006; 91(1):2-5. Accessed at: Johnson CP, Myers SM. Identification and evaluation of children with autism spectrum disorders. Pediatrics 2007;120: Bridgemohan C, Augustyn M, Parker S, Torchia M. Surveillance and screening for autism spectrum disorders in primary care. In: UpToDate, Rose, BD (ed), UpToDate, Waltham, MA. April, /26/11 New evidence review was conducted by the MCG Committee. The document was approved without revision Update Review 13. Yoder P, Stone WL. A randomized comparison of the effect of two prelinguistic communication interventions on the acquisition of spoken communication in preschoolers with ASD. J Speech Lang Hear Res. 2006;49(4): Yoder P, Stone WL. Randomized comparison of two communication interventions for preschoolers with autism spectrum disorders. J Consult Clin Psychol. 2006;74(3): American Speech-Language-Hearing Association (ASHA) [website]. Accessed at: American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Arlington, VA. American Psychiatric Association, Weissman L, Bridgemohan C. Autism spectrum disorder in children and adolescents: Overview of management. In: UpToDate, Rose, BD (ed), UpToDate, Waltham, MA. Feb, Lounds Taylor J, Dove D et al. Interventions for Adolescents and Young Adults with Autism Spectrum Disorders [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Aug. Report No.: 12-EHC063-EF. AHRQ Comparative Effectiveness Reviews. 19. Warren Z, Veenstra-VanderWeele J et al. Therapies for Children with Autism Spectrum Disorders. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Apr. Report No.: 11-EHC029-EF. Page 7 of 8

8 AHRQ Comparative Effectiveness Reviews. Accessed at: Adams C1, Lockton E et al. The Social Communication Intervention Project: a randomized controlled trial of the effectiveness of speech and language therapy for school-age children who have pragmatic and social communication problems with or without autism spectrum disorder. Int J Lang Commun Disord May- Jun;47(3): doi: /j x. Epub 2012 Mar Centers for Medicare & Medicaid (CMS). Final Report on State Services Autism Spectrum Disorders (ASDs) Services Project. April, Accessed at: Agency for Healthcare Research and Quality. Comparative Effectiveness of Therapies for Children With Autism Spectrum Disorders, Comparative Effectiveness Review No. 26, prepared by the Vanderbilt Evidence-based Practice Center under Contract No I for the Agency for Healthcare Research and Quality, April Accessed at: American Academy of Pediatrics (AAP). Committee on Children with Disabilities. Auditory integration training and facilitated communications for autism. Pediatrics Aug;102(2 Pt 1): A statement of reaffirmation for this policy was published on February 1, Accessed at: Advanced Medical Review (AMR): Policy reviewed by a physician board certified in Pediatrics, Developmental-Behavioral Pediatrics. May 23, Page 8 of 8