INTENSIVE BEHAVIORAL THERAPY FOR AUTISM SPECTRUM DISORDER

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1 INTENSIVE BEHAVIORAL THERAPY FOR AUTISM SPECTRUM DISORDER Protocol: MEH001 Effective Date: November 1, 2017 Table of Contents COMMERCIAL AND MEDICARE COVERAGE RATIONALE... 1 MEDICAID COVERAGE RATIONALE... 5 DESCRIPTION OF SERVICES CLINICAL EVIDENCE U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPLICABLE CODES REFERENCES PROTOCOL HISTORY/REVISION INFORMATION INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice. This policy does not govern Medicare Group Retiree members. UnitedHealthcare may also use tools developed by third parties, such as the MCG Care Guidelines, to assist us in administering health benefits. The MCG Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. COMMERCIAL AND MEDICARE COVERAGE RATIONALE IMPORTANT NOTE FOR COMMERCIAL COVERAGE RATIONALE: The state of Nevada mandates benefit coverage for Applied Behavioral Analysis (ABA) for treatment of autism spectrum disorders. The applicable mandate must be followed for the commercial products for fully-insured business. The commercial coverage rationale included in this section should be followed for all fully-insured products in the state of Nevada. For commercial products that are not fully-insured, please follow the Medicaid coverage rationale. Requires Medical Director Approval Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 1 of 31

2 Intensive behavioral therapy/applied Behavioral Analysis (ABA) is covered for the treatment of autism spectrum disorders (i.e., autistic disorder, Asperger's disorder, Rett syndrome, pervasive development disorder). This service is covered when all of the following conditions are met: 1. The referral to test the child needs to be signed by a licensed physician or a licensed psychologist. a. All referrals must be prior authorized, and b. The child is to undergo medically necessary assessments; evaluations including neuropsychological evaluations, genetic testing, and other needed evaluations. The tests given must be standardized tests. 2. The diagnosis is to be given by a licensed physician and/or a licensed neuropsychologist. a. A diagnosis of Autism Spectrum Disorder needs to meet the criteria outlined in the most recent edition of the American Academy of Pediatrics Diagnostic & Statistical Manual for Primary Care: Child and Adolescent Version (DSM-PC) and/or the appropriate ICD-10 diagnosis code. b. The child must score in the clinically significant range or with a probability or high probability of autism on a standardized test administered by the licensed physician, neuropsychologist or other approved certified provider. c. The diagnosis is valid for 12 months once the child is diagnosed. d. A licensed physician or licensed neuropsychologist may determine if a shorter or longer diagnosis period is appropriate. e. A licensed physician or licensed neuropsychologist may modify the insured s diagnosis based on the results of the testing. 3. A treatment plan for rehabilitative care must be submitted to the health plan within 4 weeks of the evaluation. a. The treatment plan must be based on evidence-based screening criteria and the child s tests results. b. The plan should include all of the following: the medical diagnosis, proposed treatment by type, the frequency and duration of treatment, anticipated outcomes stated as goals, the frequency with which the treatment plan will be updated, a signature of the treating licensed psychologist or licensed behaviorist, and documentation that the treatment starts no later than 4 weeks of the evaluation. Note: Rehabilitative care is defined as professional programs including Applied Behavioral Analysis (ABA), in which the child makes clear, measurable progress as determined by an autism services provider, towards attaining goals outlined in the treatment plan. 4. The health plan may ask for an updated treatment plan every 6 months. a. The treatment plan should be reviewed by the health plan every 6 months unless the licensed provider proposes a change in the plan before 6 months. Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 2 of 31

3 b. If the licensed neuropsychologist or licensed physician determined the diagnosis to be appropriate for a period longer than 12 months, the period may not exceed 3 years. c. The diagnosis part of the treatment plan needs to be re-evaluated at least every 3 years depending upon the initial recommendation from the licensed neuropsychologist or licensed physician. 5. Members suspected of having an Autism Spectrum Disorder will be referred for neuropsychiatric testing. The referrals will be reviewed by a medical director and if approved, will be routed to a contracted neuropsychologist or approved developmental professional. The following lists the most common standardized neuropsychological assessment tests used in diagnosing cognitive disorders. (This list may not be all-inclusive): Autism Diagnostic Observations Schedule Bayley Scales of Infant and Toddler Development, Third Edition Childhood Autism Rating Scale Gilliam Autism Rating Scale 6. The following procedures/services for the assessment of autism spectrum disorders (ASD) are considered not medically necessary as they are considered experimental, investigational and/or unproven for this indication (these lists may not be all-inclusive): Assessment: Allergy testing (e.g., food allergies for gluten, casein, candida, molds) Celiac antibodies testing erythrocyte glutathione peroxidase studies Event-related potentials (i.e., evoked potential studies) Hair analysis Immunologic or neurochemical abnormalities testing Intestinal permeability studies Magnetoencephalography (MEG) Micronutrient testing (e.g., vitamin level) Mitochondrial disorders testing (e.g., lactate and pyruvate) Provocative chelation tests for mercury Stool analysis Urinary peptides testing 8. The following procedures/services for the treatment of ASD are considered not medically necessary as they are considered experimental investigational and/or not medically necessary for this indication (these lists may not be all inclusive) Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 3 of 31

4 Treatment: Auditory integration therapy Augmentative communication devices Chelation therapy Cognitive rehabilitation and cognitive behavioral therapies (are used primarily for traumatic brain injury) Craniosacral therapy Dietary and nutritional interventions (e.g., elimination diets, vitamins) Facilitated communication Holding therapy Hyperbaric oxygen therapy Immune globulin therapy Music therapy Secretin infusion Sensory integration therapy Vision therapy Intensive behavioral therapy/applied behavioral analysis including Early Start Denver Model (ESDM) programs, and Relationship Development Intervention (RDI) are unproven and not medically necessary for the treatment of autism spectrum disorder. The effectiveness of specific behavioral interventions, the duration and intensity of the interventions and the characteristics of children who respond have not been established in the published medical literature. According to the 2014 Agency for Healthcare Research and Quality (AHRQ) Behavioral Interventions for Children with Autism Spectrum Disorder update, the evidence is insufficient to adequately identify and target the children who are most likely to benefit (or not benefit) from specific interventions. The authors of the AHRQ report also state that intervention response is likely moderated by both treatment and child factors, but exactly how these factors function is not entirely clear (Weitlauf, et al. 2014). Additional studies are required to define optimal treatment approaches for autistic children with specific areas of deficit and to identify which treatment variables or components are responsible for significant effect. Furthermore, it is not clear what the optimal age is to begin intensive behavioral therapy, how long intensive behavioral therapy should last, and the what the durability of treatment effect is when intensive behavioral therapy is stopped. These issues should be addressed using rigorous methodologies, including randomization, standardized protocols, use of blinded evaluators, treatments that adhere to specific models, and longitudinal designs to evaluate long-term outcome. Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 4 of 31

5 Centers for Medicare and Medicaid Services (CMS): There is no coverage for Medicare for Autism and/or Autism Spectrum Disorders. Medicare does not have a National Coverage Determination or a Local Coverage Determination for Nevada for Autism Spectrum Disorder (Accessed September 2017). For Medicare and Medicaid Determinations Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage database on the Centers for Medicare and Medicaid Services Website. MEDICAID COVERAGE RATIONALE Medicaid Services Manual, Chapter Healthy Kids Program, Policy #15-3. Effective January 1, Accessed September 8, Applied Behavior Analysis (ABA) is the design, implementation and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvement in human behavior, including the use of direct observation, measurement and functional analysis of the relations between environment and behavior. ABA is a behavior intervention model based on reliable evidence based practices focusing on targeted skills in all areas of development. The Division of Health Care Financing and Policy (DHCFP) utilizes the Center for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP), and Behavior Analyst Certification Board (BACB) Applied Behavior Analysis Treatment of Autism Spectrum Disorder: Practice Guidelines for Healthcare Funders and Managers (2nd ed.) as guiding principles for this policy. A comprehensive array of preventive, diagnostic, and treatment services are a mandatory benefit under the Medicaid program for categorically needy individuals under age 21, including children with Autism Spectrum Disorder (ASD). Definitions Applied Behavior Analysis (ABA) is the design, implementation and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvement in human behavior, including the use of direct observation, measurement and functional analysis of the relations between environment and behavior. Autism Spectrum Disorder (ASD) is a group of developmental disabilities that can cause significant social, communication and behavioral challenges. Policy Medicaid will reimburse for ABA rendered to Medicaid eligible individuals under age 21 in accordance with Early and Periodic Screening, Diagnostic and Treatment (EPSDT) coverage authority. The behavior intervention must be medically necessary (reference MSM 100) to develop, maintain, or restore to the maximum extent practical the functions of an individual with a diagnosis of ASD or other condition for which ABA is recognized as medically necessary. It must be rendered according to Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 5 of 31

6 the written orders of the Physician, Physician s Assistant or an Advanced Practitioner Registered Nurse (APRN). The treatment regimen must be designed and signed off on by the qualified ABA provider. The services are to be provided in the least restrictive, most normative setting possible and may be delivered in a medical professional clinic/office, within a community environment, or in the recipient s home. All services must be documented as medically necessary and appropriate and must be prescribed on an individualized treatment plan. Coverage and Limitations Covered Services 1. There are two types of ABA treatment delivery models recognized by the DHCFP, Focused and Comprehensive. Based upon the Behavior Analyst Certification Board (BACB), Inc. (2014) within each of the two delivery models there are key characteristics which must be demonstrated throughout the assessment and treatment. These characteristics include: a. Comprehensive assessment that describes specific levels of baseline behaviors when establishing treatment goals. b. Establishing small units of behavior which builds towards larger changes in functioning in improved health and levels of independence. c. Understanding the current function and behaviors targeted for treatment. d. Use of individualized and detailed behavior analytic treatment. e. Ongoing and frequent direct assessment, analysis and adjustments to the treatment plan by a Behavior Analyst by observations and objective data analysis. f. Use of treatment protocols that are implemented repeatedly, frequently, and consistently across all environments. g. Direct support and training of family members and other involved qualified professionals. h. Supervision and management by a licensed provider with expertise and formal training in ABA for treatment of ASD. Applied Behavior Analysis Treatment of Autism Spectrum Disorder: Practice Guidelines for Healthcare Funders and Managers (2014) (2 nd ed.). 2. Focused Delivery Model a. Focused ABA is treatment directly provided to the individual for a limited number of specific behavioral targets. I. The appropriate target behaviors are prioritized. When prioritizing multiple target areas, the following behaviors are considered: i. behaviors that may threaten the health and safety of themselves or others; and ii. absence of developmentally appropriate adaptive, social or functional skills. II. Treatment may be delivered in individual or small group format. 3. Comprehensive Delivery Model a. Comprehensive ABA is treatment provided to the individual for a multiple number of targets across domains of functioning including cognitive, communicative, social and emotional. I. The behavior disorders may include co-occurring disorders such as aggression, selfinjury and other dangerous disorders. II. Treatment hours are increased and decreased as recipient responds to treatment goals. Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 6 of 31

7 III. Treatment is intensive and initially provided in a structured therapy setting. As recipient progresses towards treatment goals the setting may be expanded to alternative environments such as group settings. 4. Services covered within the ABA delivery models a. Behavioral Screening - A brief systematic process to determine developmental delays and disabilities during regular well-child doctor visits. Screens must be a nationally accepted Developmental Screen. Refer to Chapter 600 of the MSM for coverage of developmental screens. b. Comprehensive Diagnostic Evaluations - Is the further review and diagnosis of the child s behavior and development. Coverage of this service is found within Chapter 600 of the MSM. c. Behavioral Assessment - A comprehensive assessment is an individualized examination which establishes the presence or absence of developmental delays and/or disabilities and determines the recipient s readiness for change, and identifies the strengths or problem areas that may affect the recipient s treatment. The comprehensive assessment process includes an extensive recipient history which may include: current medical conditions, past medical history, labs and diagnostics, medication history, substance abuse history, legal history, family, educational and social history, and risk assessment. The information collected from this comprehensive assessment shall be used to determine appropriate interventions and treatment planning. d. Adaptive Behavioral Treatment Intervention - Is the systematic use of behavioral techniques and intervention procedures to include intensive direction instruction by the interventionist and family training and support. e. Adaptive Behavioral Family Treatment - The training in behavioral techniques to be incorporated into daily routines of the child and ensure consistency in the intervention approach. The training should be extensive and ongoing and include regular consultation with the qualified professional. The training is broken down into two components: I. Family Treatment with the child present Is training that includes the parent/guardian or authorized representative in behavioral techniques during the behavior intervention with the child. II. Family Treatment without the child present Is training in behavioral techniques provided to the parent/guardian or authorized representative without the child present. The training may be for the review of prior adaptive behavioral treatment sessions to break down the exhibited behavior and training techniques. 5. The coverage of ABA services require the following medical coverage criteria to be met: a. The recipient must be zero to under 21 years of age; b. Have an established supporting diagnosis of ASD; c. The individual exhibits excesses and/or deficits of behavior that impedes access to age appropriate home or community activities (examples include, but are not limited to aggression, self-injury, elopement, and/or social interaction, independent living, play and/or communication skills, etc.); d. ABA services are rendered in accordance with the individual s treatment plan with realistic and obtainable treatment goals to address the behavioral dysfunction; e. Treatment may vary in intensity and duration based on clinical standards. Approval of fewer hours than recommended/supported in clinical literature requires justification based on objective findings in the medical records; Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 7 of 31

8 f. A reasonable expectation on the part of the treating healthcare professional that the individual will improve, or maintain to the maximum extent practical functional gains with behavior intervention services; g. The treatment plan must be based on evidence-based assessment criteria and the individual s test results; h. Behavioral assessments which are previously performed at the Local Education Agency (LEA) must be utilized and not duplicatively billed under the DHCFP if current (within six months) and clinically appropriate; and i. Services must be prior authorized. 6. Services may be delivered in an individual or group (two to eight individuals) treatment session. 7. Services may be delivered in the natural setting (i.e. home and community-based settings, including clinics). Non Covered Services 1. Services which do not meet Nevada Medicaid medical necessity requirements. 2. Services used to reimburse a parent/guardian for participation in the treatment plan. 3. Services rendered by the parent/guardian. 4. Services that are duplicative services under an IFSP or an IEP. 5. Treatment whose purpose is vocationally or recreationally based. 6. Services, supplies, or procedures performed in a non-conventional setting including but not limited to Resorts, Spas, and Camps. 7. Custodial services: a. For the purpose of these provisions, custodial care: I. shall be defined as care that is provided primarily to assist in the activities of daily living (ADLs) such as bathing, dressing, eating, and maintaining personal hygiene and safety; II. is provided primarily for maintaining the recipient s or anyone else s safety; and III. could be provided by persons without professional skills or training. 8. Parenting services without a diagnosis of ASD. 9. Services not authorized by the QIO-like vendor if an authorization is required according to policy. 10. Respite services. 11. Child care services. 12. Services for education. 13. Equine therapy. 14. Hippo therapy. 15. Phone consultation services. 16. Care coordination and treatment planning billed independently of direct service. 17. ABA services cannot be reimbursed on the same day as other rehabilitative mental health services as described within Chapter 400 of the MSM. Provider Qualifications In order to be recognized and reimbursed as an ABA provider by the DHCFP, the provider must be one of the following: Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 8 of 31

9 1. Licensure as a Physician by the Nevada State Board of Medical Examiners acting within their scope of practice (NRS , , , 633 Nevada Administrative Code (NAC) ), and 42 CFR A Psychologist licensed under NRS A qualified Behavior Analyst is an individual who has earned a master s degree level and/or doctorate from an accredited college or university in a field of social science or special education and holds a current certificate as a Board Certified Behavior Analyst (BCBA and BCBA-D) by the BACB, Inc., and licensed by the Nevada State Board of Psychological Examiners under NRS A qualified Assistant Behavior Analyst is an individual who has earned a bachelor s degree from an accredited college or university in a field of social science or special education and holds a current certification as a Board Certified Assistant Behavior Analyst (BCaBA) by the BACB, Inc., and licensed by the Nevada State Board of Psychological Examiners under NRS and is under the direction of a physician, psychologist, BCBA-D, or BCBA. 5. A Registered Behavior Technicians (RBT) is an individual who has earned a high school diploma or equivalent, completed training and testing as approved and credentialed by the BACB, Inc., and acting within the scope of practice under direction of a physician, psychologist, BCBA-D, BCBA, or BCaBA. Supervision Standards Clinical Supervision as established by NRS , which includes: program development, ongoing assessment and treatment oversight, report writing, demonstration with the individual, observation, interventionist and parent/guardian training/education, and oversight of transition and discharge plans. All supervision must be overseen by a Licensed Psychologist, BCBA-D or BCBA who has experience in the treatment of autism, although the actual supervision may be provided by a BCaBA at their direction. The amount of supervision must be responsive to individual needs and within the general standards of care and may temporarily increase to meet the individual needs at a specific period in treatment. Provider Responsibility 1. The provider will allow, upon request of proper representatives of the DHCFP, access to all records which pertain to Medicaid recipients for regular review, audit or utilization review. 2. Once an approved prior authorization request has been received, providers are required to notify the recipient in a timely manner of the approved service units and service period dates. 3. Ensure services are consistent with applicable professional standards and guidelines relating to the practice of ABA as well as state Medicaid laws and regulations and state licensure laws and regulations. 4. Ensure caseload size is within the professional standards and guidelines relating to the practice of ABA. Parent/Guardian Responsibility The parent/guardian when applicable must: 1. Be present during all provider training and supervisory visits that occur during home-based services. A parent/guardian may designate an authorized representative, who is 18 years of age or older, to participate in the parent/guardians absence during home-based services. 2. Participate in discussions during supervisory visits and training. Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 9 of 31

10 3. Participate in training by demonstrating taught skills to support generalization of skills to the home and community environment. 4. Sign the treatment plan indicating an understanding and agreement of the plan. 5. Participate in treatment hours. 6. Keep scheduled appointments. 7. Inform provider within 24 hours if the appointment needs to be rescheduled. Treatment Plan All ABA services must be provided under a treatment plan developed and approved by a licensed psychologist, BCBA-D or BCBA, supported by a BCaBA where applicable. The licensed psychologist, BCBA-D, or BCBA trains the BCaBA and RBT to implement assessment and intervention protocols with the individual, and provides training and instruction to the parent/guardian and caregiver as necessary to support the implementation of the ABA treatment plan. The licensed psychologist, BCBA-D, or BCBA is responsible for all aspects of clinical direction, supervision, and case management. ABA services shall be rendered in accordance with the individual s treatment plan that is reviewed no less than every six months by a licensed psychologist, BCBA-D, or BCBA. All treatment plans are based on documentation of medical necessity for specific treatment goals to address specific behavior targets based on the appropriate treatment model. The treatment plan shall include: 1. Goals derived from the functional assessment and/or skill assessment that occur prior to initiation of treatment, and relating to the core deficit derived from the assessment; 2. Specific and measurable objectives to address each skill deficit and behavioral excess goal: a. Delineate the baseline levels of target behaviors; b. Identify short, intermediate, and long-term goals and objectives that are behaviorally defined; c. Criteria that will be used to measure achievement of behavioral objectives; and d. Target dates for when each goal will be mastered. 3. Interventions consistent with ABA techniques; 4. Specific treatment, intervention including amount, scope, duration and anticipated provider(s) of the services; 5. Training and supervision to enable the BCaBAs and RBTs to implement assessment and treatment protocols; 6. Care coordination involving the parent/guardian, community, school, and behavior health and/or medical providers who are concurrently providing services. Care coordination must include parent/guardian s documented consent; 7. Parent/guardian training, support and participation; 8. Parent/guardian or designated authorized representative responsibility to be physically present and observant during intervention process occurring in the home; 9. Parent/guardian signature; and 10. Discharge criteria to include requirements of discharge, anticipated discharge date, next level of care, and coordination of other services. Note: HPN will ask for a treatment plan to be re-evaluated at least every three years. Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 10 of 31

11 Discharge Plan All ABA services must include discharge criteria as a written component of the treatment plan at the initiation of services and updated throughout the treatment process; involving a gradual step down in services. Discharge planning should include the details of monitoring and follow up for the individual. 1. Discharge planning should occur when: a. The individual has achieved treatment goals; or b. The individual no longer meets the diagnostic criteria for ASD; or c. The individual does not demonstrate progress towards goals for successive authorization periods; or d. The parent/guardian requests to discontinue services; or e. The parent/guardian and provider are unable to reconcile concerns in treatment planning and delivery. 2. Discharge plan must identify: a. The anticipated duration of the overall services; b. Discharge criteria; c. Required aftercare services; d. The identified agency(ies) or Independent Provider(s) to provide the aftercare services; and e. A plan for assisting the recipient in accessing these services. A Discharge summary is written documentation of the last service contact with the recipient, the diagnosis at admission and termination, and a summary statement that describes the effectiveness of the treatment modalities and progress, or lack of progress, towards treatment goals and objectives, as documented in the ABA treatment plan. The discharge summary also includes the reason for discharge, current level of functioning, and recommendations for further treatment. DEFINITIONS Applied behavior analysis means the design, implementation and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvement in human behavior, including, without limitation, the use of direct observation, measurement and functional analysis of the relations between environment and behavior. Autism behavior interventionist means a person who is registered as a Registered Behavior Technician or an equivalent credential by the Behavior Analyst Certification Board, Inc., or its successor organization, and provides behavioral therapy under the supervision of: (1) A licensed psychologist; (2) A licensed behavior analyst; or (3) A licensed assistant behavior analyst. Autism spectrum disorders means a neurobiological medical condition including, without limitation, autistic disorder, Asperger s Disorder and Pervasive Developmental Disorder not otherwise specified. Behavioral therapy means any interactive therapy derived from evidence-based research, including, without limitation, discrete trial training, early intensive behavioral intervention, intensive intervention programs, pivotal response training and verbal behavior provided by a licensed psychologist, licensed behavior analyst, licensed assistant behavior analyst or certified autism behavior interventionist. Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 11 of 31

12 Evidence-based research means research that applies rigorous, systematic and objective procedures to obtain valid knowledge relevant to autism spectrum disorders. Habilitative or rehabilitative care means counseling, guidance and professional services and treatment programs, including, without limitation, applied behavior analysis, that are necessary to develop, maintain and restore, to the maximum extent practicable, the functioning of a person. Licensed assistant behavior analyst means a person who holds current certification or meets the standards to be certified as a board certified assistant behavior analyst issued by the Behavior Analyst Certification Board, Inc., or any successor in interest to that organization, who is licensed as an assistant behavior analyst by the Board of Psychological Examiners and who provides behavioral therapy under the supervision of a licensed behavior analyst or psychologist. Licensed behavior analyst means a person who holds current certification or meets the standards to be certified as a board certified behavior analyst or a board certified assistant behavior analyst issued by the Behavior Analyst Certification Board, Inc., or any successor in interest to that organization, and who is licensed as a behavior analyst by the Board of Psychological Examiners. Prescription care means medications prescribed by a licensed physician and any health-related services deemed medically necessary to determine the need or effectiveness of the medications. Psychiatric care means direct or consultative services provided by a psychiatrist licensed in the state in which the psychiatrist practices. Psychological care means direct or consultative services provided by a psychologist licensed in the state in which the psychologist practices. Screening for autism spectrum disorders means medically necessary assessments, evaluations or tests to screen and diagnose whether a person has an autism spectrum disorder. Therapeutic care means services provided by licensed or certified speech pathologists, occupational therapists and physical therapists. Treatment plan means a plan to treat an autism spectrum disorder that is prescribed by a licensed physician or licensed psychologist and may be developed pursuant to a comprehensive evaluation in coordination with a licensed behavior analyst. DESCRIPTION OF SERVICES According to the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction, including deficits in social reciprocity, nonverbal communicative behaviors and skills in developing, maintaining, and understanding relationships. The 5th edition of DSM includes several significant changes over the previous edition, including combining several previously separate diagnoses such as Asperger s disorder, autistic disorder, pervasive development disorder, atypical autism, childhood autism, childhood disintegrative disorder, early infantile autism, and highfunctioning autism under the single diagnosis of autism spectrum disorder (DSM-5). Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 12 of 31

13 Behavioral therapy programs used to treat autism spectrum disorder are referred to as Intensive Behavioral Intervention (IBI), Early Intensive Behavioral Intervention (EIBI), or Applied Behavior Analysis (ABA) including Lovaas therapy. The Early Start Denver Model (ESDM) program includes ABA in combination with developmental and relationship-based approaches. This therapy involves highly structured teaching techniques that are administered on a one-to-one basis by a trained therapist, paraprofessional, and/or parent 25 to 40 hours per week for 2 to 3 years. In classic IBI therapy, the first year of treatment focuses on reducing self-stimulatory and aggressive behaviors, teaching imitation responses, promoting appropriate toy play, and extending treatment into the family. In the second year, expressive and abstract language is taught, as well as appropriate social interactions with peers. Treatment in the third year emphasizes development of appropriate emotional expression, preacademic tasks, and observational learning from peers involved in academic tasks. In an IBI therapy session, the child is directed to perform an action. Successful performance of the task is rewarded with a positive reinforcer, while noncompliance or no response receives a neutral reaction from the therapist. Although once a component of the original Lovaas methodology, aversive consequences are no longer used. This instructional method is known as discrete trial discrimination learning and compliance. Food is usually most effective as a positive reinforcer for autistic children, although food rewards are gradually replaced with social rewards, such as praise, tickles, hugs, or smiles. Parental involvement is considered essential to long-term treatment success; parents are taught to continue behavioral modification training when the child is at home, and may sometimes act as the primary therapist (Hayes, 2014). Applied behavior analysis includes the use of adaptive behavior treatment that consists of individual and family or group treatment, social skills training, and exposure treatment. Adaptive behavior treatment may be provided to patients presenting with deficient adaptive or maladaptive behaviors (e.g., impaired social skills and communication). Relationship Development Intervention (RDI) is a program designed to guide parents of children with autism spectrum disorder (ASD) and similar developmental disorders to function as facilitators for their children's mental development. The intention of RDI is to teach parents to play an important role in improving critical emotional, social, and metacognitive abilities through carefully guided interaction in daily activities (Gutstein 2009). CLINICAL EVIDENCE Summary of Clinical Evidence Conclusions from several meta-analyses and large-scale technology assessments have suggested that the evidence to support the use of Intensive Behavioral Therapy (IBT) for the treatment of autism spectrum disorder is promising. Studies have demonstrated medium to large effects of IBT on intellectual functioning, language related outcomes (IQ, receptive and expressive language, communication), acquisition of daily living skills and social functioning. These effects have been observed both relative to no intervention as well as in comparison to other treatments. However, despite these promising outcomes, there are several weaknesses and limitations in the research to-date on Intensive Behavioral Therapy for the treatment of autism spectrum disorder. Several meta-analyses and large-scale assessments have concluded that there were major limitations in design and methodology in the studies they evaluated. In addition to the use of single case studies or Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 13 of 31

14 small sample sizes, general quality standards of clinical studies were inconsistently used, including randomization to group assignment, blind assessments, intent-to-treat analysis, and the use of prospective designs. Although random-effects meta-analysis and sensitivity analysis may partially compensate for some of these deficits, problems were identified at the meta-analysis level as well. One review of five recent meta-analyses observed that all of the meta-analyses had at least one methodological limitation, such as calculation of effect size based on small samples, inclusion of nonrandomized studies, and lack of standardized comparison or control groups. These research weaknesses suggest the need for future research using stronger methodology to replicate current findings and demonstrate clear effectiveness and generalization of effect. In addition, comparisons of particular Applied Behavior Analysis (ABA) interventions are needed, as well as measurement of the treatment fidelity of the various interventions provided. Future research also needs to identify the characteristics of children who respond best to particular treatments, as well as to identify the duration and intensity of treatment needed to produce positive outcomes. Findings from the specific studies are presented below. The focus of the clinical evidence review is on technology assessments and published meta-analyses and systematic reviews that evaluated the reliability and validity of randomized controlled trials that compared IBT to other treatments for autism spectrum disorder. Clinical Trials The original work by Lovaas (1987) studied the effect of intensive behavioral therapy on IQ levels in 19 children. Subjects in the experimental group had an average gain of 30 points while the IQ levels of control group subjects were unchanged. While this is considered a landmark study, the small sample size and lack of long term follow up limits the generalizability of the findings. The Lovaas study had potential selection bias due to inclusion/exclusion criteria, lack of randomization, the questionable sensitivity of measurement instruments and the relevance of study endpoints. McEachin et al. (1993) evaluated the long term effect of intensive behavioral therapy (IBT)/ applied behavioral analysis (ABA) on the subjects involved in the Lovaas study and concluded that the children maintained the gains in IQ. The authors concluded that the long term follow up established the impact of the treatment, but the sample size remained small and the impact of the increased IQ was not correlated with changes in social or interpersonal functioning. Both studies excluded low-functioning autistic subjects. Systematic Reviews/Meta-Analyses Roth et al. (2014) evaluate the effectiveness of behavioral interventions for adolescents and adults with autism spectrum disorders (ASD) by conducting a meta-analysis of published single-case research studies. A new metric for calculating effect size in single-case research, nonoverlap of all pairs, was utilized. In addition, the certainty of evidence, a system to evaluate research methodology, was applied to the reviewed articles. Forty-three articles were identified in the study. Results suggested that the behavioral interventions in the areas of academic skills, adaptive skills, problem behavior, phobic avoidance, social skills, and vocational skills have medium-to-strong effect sizes. Medium-to-high confidence in findings was noted for 81 % of the studies in the meta-analysis; however, three-fourths of the reviewed studies did not include treatment integrity, which may affect the ability to draw conclusions about the effectiveness of the interventions. According to the authors, the evidence is promising for the use of behavioral interventions for this population; however, additional research and Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 14 of 31

15 dissemination are needed to fill the gap between research and practice in order for practitioners to meet the increasing demand as individuals with ASD age. Bishop-Fitzpatrick et al. (2013) conducted a systematic review of all peer-review studies evaluating psychosocial interventions for adults with ASD. A total of 1,217 studies were reviewed, only 13 met inclusion criteria. The majority of studies were single case studies or non-randomized controlled trials, and most focused on applied behavior analysis or social cognition training. Effects of psychosocial treatment in adults with ASD were largely positive ranging from d = , although the quantity and quality of studies is limited. According to the authors, there is substantial need for the rigorous development and evaluation of psychosocial treatments for adults with ASD. Strauss et al. (2013) completed a comprehensive synthesis of six meta-analyses of early intensive behavioral interventions (EIBI) for young children with autism spectrum disorders published from 2009 to The intent of the analysis was to consider the extent of parent inclusion in different treatment delivery formats. The analysis was completed by obtaining standardized mean difference effect sizes for 13 comparative studies ordered by comparison study type and 22 mean change effect sizes ordered by treatment delivery type. Results of the analysis suggested that EIBI leads generally to positive medium-to-large effects for three available outcome measures: intellectual functioning, language skills and adaptive behaviors. Although favorable effects were apparent across comparative studies, analysis by type of delivery format revealed that EIBI programs that include parents in treatment provision are more effective. Mediator analyses suggest that treatment variables and child characteristics impact program effectiveness when accounting for the extent of parent inclusion. Overall sample sizes of the studies used in this analysis were relatively small with a range in studies from children. Virues-Ortega et al. (2013) used meta-analytical procedures to examine the pooled clinical effects of Treatment and Education of Autistic and Related Communication Handicapped Children (TEACCH) in a variety of outcomes. A total of 13 studies were selected for meta-analysis totaling 172 individuals with autism exposed to TEACCH. Standardized measures of perceptual, motor, adaptive, verbal and cognitive skills were identified as treatment outcomes. Inverse-variance weighted random effects metaanalysis supplemented with quality assessment, sensitivity analysis, meta-regression, and heterogeneity and publication bias tests were used. The results suggested that TEACCH effects on perceptual, motor, verbal and cognitive skills were of small magnitude in the meta-analyzed studies. Effects over adaptive behavioral repertoires including communication, activities of daily living, and motor functioning were within the negligible to small range. There were moderate to large gains in social behavior and maladaptive behavior. According to the authors, the effects of the TEACCH program were not moderated by aspects of the intervention such as duration (total weeks), intensity (hours per week), and setting (home-based vs. center-based). Reichow (2012a) conducted an overview of five meta-analyses of IBI for young children that were published from 2009 to Meta-analyses included in the overview were those from Eldevik et al. (2009), Reichow and Wolery (2009), Spreckley and Boyd (2009), Virués-Ortega (2010), and Makrygianni and Reed (2010). Four of the five meta-analyses concluded that IBI was an effective intervention for many children with ASD. According to the author, all five of the meta-analyses had a least one methodological limitation, including calculation of effect size based on small samples (in some cases without reference to a control group), inclusion of nonrandomized studies, over-inclusion Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 15 of 31

16 of participant data, and lack of standardized comparison or control groups. The author concluded the overview of the five selected meta-analyses by stating that it appeared that the average effects of IBI were strong and robust. However, the author noted that information on patient characteristics associated with best outcomes is needed. In addition, better knowledge of the treatment components (e.g. intensity, duration, level of treatment fidelity, therapist experience and/or training) necessary to achieve optimal outcomes is also required. Reichow et al. (2012b) conducted a Cochrane review and meta-analysis of the evidence for the effectiveness of early intensive behavioral intervention (EIBI) in increasing the functional behaviors and skills of young children with autism spectrum disorders (ASD). One randomized control trial (RCT), and four clinical control trials (CCTs) in which assignment to treatment was based on parental preference were included in the review, representing a total of 203 participants, all younger than 6 when they began treatment. Children in the EIBI treatment groups showed more positive outcomes than those in the generic special education comparison groups. Mean effect sizes were as follows: for adaptive behavior g = 0.69, for IQ g = 0.76, for expressive language g = 0.50, for receptive language g = 0.57, for daily communication skills g = 0.74, for socialization g = 0.42, and for daily living skills g = The authors concluded that while there is some evidence that EIBI is an effective behavioral treatment for some children with ASD, the heavy reliance on data from non-randomized studies makes the quality of the evidence low and limits the ability to draw strong conclusions about effects of EIBI for children with ASD. According to the authors, additional studies using RCT research designs are needed. In a project supported by the Agency for Healthcare Research and Quality (AHRQ), Warren et al. (2011a) published a systematic review of early intensive intervention for autism spectrum disorders for children aged 12 and younger. Thirty-four studies met inclusion criteria: 17 of these were case series, and 2 were randomized controlled trials. The authors rated 1 study as good quality, 10 as fair quality, and 23 as poor quality. Overall, the strength of the evidence ranged from insufficient to low. The authors concluded that studies of Lovaas-based approaches and early intensive behavioral intervention variants and the Early Start Denver Model (ESDM) resulted in some improvements in cognitive performance, language skills, and adaptive behavior skills in some young children with ASDs. The authors note that confidence (strength of evidence) in the effect of UCLA/Lovaas-based interventions is low because of the need for additional, confirmatory research, a lack of high-quality RCTs, and no studies that have directly compared effects of promising manualized treatment approaches. The evidence base for interventions for very young children, including the ESDM is insufficient. On balance, however, the combined research on UCLA/Lovaas-based interventions and the ESDM suggests a benefit of early intensive approaches for some children that should continue to be studied. Peters-Scheffer et al. (2011) conducted a meta-analysis to evaluate the effectiveness of comprehensive early intervention behavioral interventions (EIBI) in young children with autism spectrum disorders (ASD). The meta-analysis included 11 studies (n=344 children). There was one randomized controlled trial (n=28); the other studies were controlled pre-test or post-test designs. The randomized controlled trial showed statistically significant differences in favor of EIBI for full scale IQ and non-verbal IQ. Results for all other outcome measures were not statistically significant. The authors concluded that children who received EIBI showed higher IQ, non-verbal IQ, expressive and receptive language and adaptive behavior than those in the control groups and stated that the results strongly support EIBI in the treatment of ASD. According to the Centre for Reviews and Dissemination (CRD), this meta- Intensive Behavioral Therapy for the Treatment of Autism Spectrum Disorders.docx Page 16 of 31