Medical Policy Medical Policy
Policy Num: 03.001.005
Policy Name: AUTISM DISORDERS / PERVASIVE DEVELOPMENT DISORDERS
Policy ID: [03.001.005] [Ar / L / M+ / P] [0.00.00]
Last Review: December 26, 2024
Next Review: Policy Archived
Related Policies: None
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Interventions of interest are:
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Autism Spectrum Disorders (ASD) are a group of complex disorders which are also referred to as pervasive developmental disorders. These disorders range from a condition known as Autism or "Asperger's" Syndrome Autistic Disorder. Other two autism spectrum disorders are Rett's disorder (Rett's syndrome) and the childhood disintegration disorder.
When a child has symptoms of autism or "Asperger's" but does not meet the criteria for either of these, the diagnosis is described as pervasive development disorder not specified (PDD-NOS), also known as atypical development or atypical autism pervasive disorder. All these disorders are characterized by varying degrees of difficulty in communication skills, social interaction, and stereotypes patterns, restricted or repetitive of language and behavior.
In the fourth edition of the "Diagnostic and Statistical Manual of Mental Disorders" (DSM-IV-TR) pervasive development disorder includes: Autistic Disorders, Rett's Syndrome, Childhood Disintegration Disorders, Asperger's Syndrome, Nonspecific or Atypical Autism Pervasive Developmental Disorders. The autistic spectrum includes the following:
· Autistic Disorder: this condition refers to the classic autism that includes measurable deficits in:
o Social interaction
o Language, communication and games
o Deficits that manifest as stereotypes such as: persistent repetition of words, posture or movement without meaning, preserve a narrow range of interests and activities.
· Asperger’s Syndrome F84.5: this disorder is not associated with the significant delay in cognitive development or to difficulty with social interactions, or a small range of interests, they preserve well the fluency of the language without a lag in it.
· Non-specific pervasive developmental disorder F84.0: this disorder includes children with autistic behavior but who do not meet the criteria of other autistic spectrum disorders.
· Disintegration Disorder (Heller's syndrome) F84.3: this disorder includes previously normal children who manifest a massive regression between two and ten years of age resulting in a severe acquired autism with loss of cognitive skills.
· Rett's Syndrome: this is a specific disorder limited to girls with acquired microcephaly, childhood regression, loss in the use of the hands, stereotypical movements of the hands, severe retardation and others neurological problems.
In February 2007 the Center for Disease Control and Prevention (CDC) published data related to the prevalence of ASD. The CDC estimates that 2 to 6 per 1000 or 1 in 150 children has ASD. The risk is 3 or 4 times higher in males than in females. This is a prevalence higher than the previously shown.
The etiology of ASD is unknown, but it is apparently associated with hereditary conditions. This etiology has been identified for between 15% to 20% of individuals with autism, in the rest the cause continues to be unknown.
The autism has been associated with other medical conditions. Some disorders are associated with ASD:
· Epilepsy or seizure disorders: approximately one-third of people with autism show some sign of seizure disorder.
· Tuberous Sclerosis: approximately 6% of people with autism have this multisystem genetic disease that is characterized by tumors in the brain and other vital organs. Symptoms include seizures, behavior problems, abnormalities of the skin, kidney disease and late development.
· Fragile X Syndrome: 2.1% have this condition that is the most common cause of hereditary mental retardation.
· Mental retardation: 25% of people with autism have some degree of mental retardation.
Evaluation
Indications for an immediate evaluation of ASD includes:
· No babbling or pointing or other types of gestures for the age of 12 months.
· No pronunciation of simple words for the age of 16 months.
· No pronunciation of two-word phrases for the age of 24 months.
· Loss of language or social skills in the pre-adolescence.
The ASD assessment requires an approach by a multidisciplinary team for evaluation of the difficulties that are present. This team includes: Pediatrician, Psychiatrist, Psychologist, Neurologist, Speech Therapist, Occupational Therapist and Social Worker. There is no specific test to confirm the diagnosis of ASD (Volkmar, et al., 1999;) Tuchman, 2003; Filipek, et al., 2000/2006/2010). This evaluation must include the following:
· Clinical history: a report of parents that includes family history, pregnancies and history of neonatal development of the child, should be included. For this standardized questionnaires are used.
This evaluation must include the following: (Volkmar, et al., 1999;) Tuchman, 2003; Filipek, et al., 2000/2006/2010):
· Audiological evaluation
· Evaluation of communication: this must be done by a speech pathologist.
· Occupational evaluation by a physical or occupational therapist: they will evaluate motor impairments, motor or sensory planning and any present dysfunction.
· Screening for lead, particularly if there is pica.
· Screening for magnesium
· Cognitive assessment
The consensus is that the following tests are not necessary for the evaluation of ASD however they can be considered appropriate in the assessment of associated conditions:
· Genetic or chromosomal tests can detect a syndromic condition such as fragile-x or another genetic etiology.
· Metabolic tests
· Neuroimaging studies are indicated only if the child is a candidate for specific interventions (surgery for epilepsy)
· Electroencephalography can be performed if convulsive states are suspected.
The American Academy of Neurology (AAN) and the Child Neurology Society (CNS) have prepared parameters for the screening and diagnosis of autism based on medical evidence. These parameters include the following instruments for the evaluation that can be used in the evaluation process (Filipek et al., 2000/2006/2010):
· The Ages and Stages Questionnaire
· The BRIGNACE® screens
· The Child Development Inventories
· The Parents ‘Evaluation of Developmental Status
The AAN / CNS have developed parameters which indicate that every child that fails a routine development assessment must be screened for autism. These parameters must include the following tools (Filipek et al., 2000/2006/2010):
· Checklist for autism in children who begin to walk: this test is used for children who are 18 months of age.
· Questionnaire for autism screening: this test is used for children older than 4 years of age.
The parameters of practice of AAN / CNS indicate that the Denver II (previously known as the Denver Developmental Screening Test-Revised) is not recommended as a screening tool for autism (Filipek, et to the., 2000 / 2006 / 2010).
It also points out in the parameters of practice that evidence is insufficient to use other tests such as hair analysis to detect elements, celiac antibodies, allergy testing (particularly meals, for gluten, casein, candida or other fungi), immunological tests to detect neurochemical abnormalities, micronutrients such as levels of vitamins, studies of intestinal permeability, stool analysis, coronary peptides, disorders in the mitochondria (including lactates and pyruvate), thyroid function tests and studies of glutathione peroxidase in erythrocytes (Filipek et al., 2000/2006/2010).
These parameters of practice indicate that the recording of evoked potentials and magnetoencelography at present are research tools and that the evidence appears to have no clinical utility.
The American Academy of Pediatrics (AAP) recommends the evaluation of children for ASD and risk factors that must be observed in every preventive visit during childhood. These screening tools include clinical observation of the child, the behavior and aspects that parents have not evaluated. They also point out that a specific screening of autism should be at 18 months of age.
It has been suggested that neuropsychological tests must be used in the evaluation of ASD to help in the process of educational planning. The medical necessity to use neuropsychological tests in the evaluation and management of ASD is not documented in the medical literature. The use of these neuropsychological tests in this scenario is primarily for educational purposes and not medically necessary in the evaluation and management of these conditions.
There is insufficient evidence to demonstrate that tests of chelation for mercury in the evaluation of ASD have some value. There has been interest shown in seeing the relationship of heavy metals in particular mercury and the etiology of ASD. Tests for heavy metals (arsenic, barium, beryllium, bismuth, antimony and mercury) are not recommended in the medical literature.
Diagnosis Criteria for Autistic Disorder (299.00) * F84. 0
A. A total of 6 or more criteria of 1), 2), and 3), with at least 2 of 1 and 1 of every 1 of 2 and 3.
1) Qualitative difficulty in the social interaction manifested by at least 2 of the following:
a. Marked difficulty on the use of multiple nonverbal behaviors such as look eye to eye, facial expression, body posture and gestures that regulate social interaction.
b. Failure in developing relations with classmates appropriate for level of development.
c. Failure to interact tastes, interests, or achievements with other people in a spontaneous way.
d. Lack of emotional or social reciprocity.
2) Qualitative difficulty in communication manifested by at least 1 of the following:
a. Lack of development or late development of verbal language.
b. In individuals with appropriate verbalization and marked difficulty in the ability to initiate or maintain a conversation with others.
c. Repetitive use of stereotyped language or idiosyncratic language.
d. Lack of variety of a spontaneous social initiative appropriate to their level of development.
3) Patterns of behavior, interests, and stereotyped or repetitive activities that manifest themselves with at least one of the following:
a. Constant concern with one or more of the unlimited stereotyped patterns of interest that is abnormal in intensity or focus.
b. Inflexible adhesion to specific rituals or non-functional routines.
c. Stereotyped and repetitive mannerisms (motor) (movements with the hands, the fingers or complex movements with the body).
d. Persistent concern with parts of objects.
B. Abnormal delay or functioning in at least one of the following areas, with a start before 3 years of age:
1) Social interaction
2) Language used in social communication
3) Symbolic or imaginary games
C. The problem cannot be defined better by Rett's syndrome or Childhood Disintegration Disorder.
Diagnosis Criteria for Rett's Syndrome (299.80) * 0 F84.
A. All of the following:
1) A normal development and perinatal apparently normal
2) A psychomotor development apparently normal during the first 5 months of life.
3) A normal head circumference at birth.
B. Appearance of all of the following after a period of normal development:
1) Deceleration in the growth of the head between 5 and 48 months of age.
2) Loss of the manual skills between 5 and 30 months of age with the subsequent development of stereotyped movements of the hand (movements of the fingers or applause).
3) Loss of previously acquired social relations.
4) Emergence of uncoordinated movements in the body or when moving.
5) Severe difficulty in the development of the language with a severe psychomotor retardation.
Diagnosis Criteria for the Childhood Disintegration Disorder (299.10) * F84.3
A. It is characterized because there is an apparent normal development during the first 2 years of life that are manifested with a verbal and nonverbal communication appropriate for the age, normal social relations, games and a capacity of adaptation.
B. Significant loss of the previously acquired skills (before 10 years of age) in at least two of the following areas:
1) Receptive or expressive language
2) Adaptive behavior or social skills
3) Bladder or bowel control
4) Games
5) Motor skills
C. Anomalies in the functioning of at least two of the following areas:
1) Qualitative difficulty in social interaction (difficulty in non-verbal behavior, difficulty developing relationships with their peers, absence or lack of social or emotional reciprocity).
2) Qualitative difficulty in communication (inability to initiate or maintain a conversation, repetitive and stereotypical language, loss of language).
3) Repetitive and stereotyped behavior patterns, repetitive activities including motor and stereotyped mannerisms.
D. The problem cannot be defined better by other pervasive development disorder.
Diagnosis Criteria for the Asperger's Syndrome (299.80) *
A. Qualitative difficulty in social interaction manifested by at least two of the following:
a. Marked difficulty in the use of multiple nonverbal behaviors such as look eye to eye, facial expression, body posture and gestures that regulate social interaction.
b. Failure to develop relationships with peers appropriate to development level.
c. Failure to interact tastes, interests, or achievements with other people in a spontaneous way.
d. Lack of emotional or social reciprocity.
B. Patterns of behavior, interests, and stereotyped or repetitive activities that manifest with at least one of the following:
1) Constant concern with one or more of the unlimited stereotyped patterns of interest that is abnormal in intensity or focus.
2) Inflexible adhesion to specific rituals or non-functional routines.
3) Stereotyped and repetitive mannerisms (motor) (movements with the hands, the fingers or complex movements with the body).
4) Persistent concern with parts of objects.
C. The disorder produces a significant difficulty in the social, occupational aspect or other important functioning areas.
D. Usually there are no problems in the development of the language.
E. Generally, there are no problems in the cognitive development or in the development of skills of self- help or in the curiosities of childhood.
F. The problem cannot be defined best by another pervasive development disorder or schizophrenia.
The cause of the autism is not known, but apparently there are a great variety of genetic and not genetic factors. It has been estimated that the risk of recurrence a brother is 5%. Although it has been thought that there is a genetic cause, the identity and the number of genes involved is not known. Researchers indicate that there is not a simple biological or clinical marker for the autism or that only one gene is responsible for the condition.
The great phenotypic variability of ASD is due to the interaction of multiple genes in the individual genome and the existence of different genes and combination of genes that exist in those people affected. The exception is the Rett's disorder where mutations in the gene MECP2 are thought to be responsible for the majority of the cases of this condition.
For the majority of the patients, genetic testing will give low results unless they are performed in people with family history, medical history of presence of mental retardation or other dysmorphic findings that suggest the presence of the condition. Genetic counseling should help parents and children to establish an estimate of risk of recurrence.
The presence of dysmorphic characteristics or another specific finding may suggest a genetic screening for hereditary metabolic disorders or a chromosomal analysis.
· Rett's Disorder: this condition is one of the disorders on the autism spectrum. Molecular testing for mutations in MECP2 are clinically available. This disorder is inherited from dominant manner and associated with sex. It usually appears as a mutation of novo in the child or as inherited from a condition which induces mutation in one of the parents, which in turn have mosaicism.
· Fragile-X Syndrome: is the most common cause of inherited mental retardation and is due to a mutation in the FMR1 gene is also associated with sex. Mutations in the FMR1 gene are responsible for 98% of the cases of Fragile-X syndrome. Approximately 50% of the children with this syndrome have autistic behavior.
*Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Severity levels
The DSM - 5 recommends that in the evaluation of ASD the severity level is specified, recognizing that severity can vary in context and time. Severity must be assessed separately for each domain.
Social communication / interaction
§ Level 1 (Requires support) - Noticeable impairment without support; difficulty in initial social interaction; failed or atypical response to social situations; failure in conversation; attempts of establishing friendship fail.
§ Level 2 (Requires substantial support) - Marked deficit in communication; difficulty even with support; abnormal or reduced response to social situations
§ Level 3 (Requires extreme support) Behavior is obvious even to a casual observer; initiation of social interaction is very limited; response to social situations is minimal or none
Repetitive / Restrictive Behavior
· Level 1 (Requires support) Behavior interferes with function significantly; difficulty in changing activities; independence limited by problems of organization and planning.
· Level 2 (Requires substantial support) Behavior is obvious to the casual observer; behavior interferes with function in various situations of distress, /difficulty changing focus or action.
· Level 3 (Requires extreme support) Behavior interferes in a marked way in the function in all the spheres; extreme difficulty to adapt to change; great difficulty changing focus or action.
The DSM recommends that physicians specify the presence or absence of the following associated conditions:
· Intellectual difficulty; to diagnose comorbidity between autism spectrum disorders and intellectual disability
· Difficulty in language; (for example, simple words, nonverbal language etc.)
· Medical or genetic known conditions; (for example, Epilepsy, Rett syndrome, Down syndrome, etc.)
Other conditions related to neurodevelopment, mental conditions or behavioral disorders.
· Catatonia
Treatment
There are no effective medical interventions that achieve a cure for Autism. However, this condition can be managed through a combination of educational, pharmacological and behavioral interventions. The American Academy of Child and Adolescent Psychiatry (AACAP) proposes that the parameters of treatment must be based on a solid and empirical evidence of high quality.
AACAP guidelines indicate that the educational services include special education, forms of behavior modification and other services. They are the central and integral aspect in the treatment of ASD. Psychosocial intervention includes training to the parents in behavior modification techniques and referral to support groups. They also point out in the literature that there is not a unique approach that is good for all ASD patients.
The deficit in the communication is frequent in ASD and treatment with speech pathologists is considered favorably in the treatment. When these deficits are accompanied or coincide with a difficulty in speaking due to a separate neurological cause, speech therapy may be medically necessary.
Physical therapy and occupational therapy may be necessary in the management of motor deficit if there is potential for functional improvement.
Treatments attempted for this condition include intervention in the behavior, education, medical treatment, adjunctive therapy and alternative medicine. It also includes acupuncture and massage.
· Behavior intervention: some studies suggest that cognitive behavioral therapy interventions are effective in reducing the symptoms of anxiety.
· Educational Intervention: known as Treatment and Education of the Autistic and Communication Related to Handicapped Children (TEACCH). The evidence shows that TEACCH has a very broad base and the educational approach with computer programs are included in this category. The long term results of these studies are insufficient and inconsistent. More studies are necessary.
· Medical intervention: evidence favors the use of medications to modify behavior. The antipsychotic risperidone and aripiprazole have shown improvements in behavior as estimated by parents. Both medications have significant side effects including: weight gain, sedation, and risks of extra pyramidal symptoms.
· Allied Health: studies in this aspect have shown improvements in the acquisition of language through language and communication interventions.
Pharmacological treatment: AACAP guidelines point out that the medications are not specific to Autism and do not treat the heart of the disorder symptoms, however, they are useful for symptoms that interfere with the participation and educational interventions or anxiety situations of the individual. Pharmacological treatment includes:
· Selective Serotonin Reuptake Inhibitors (SSRIs): this is a group of antidepressants to reduce the frequency and intensity of repetitive behaviors, treat irritability and reduce aggressive behavior.
· Tricyclic Agents and antidepressants: can be very effective in some people. Can have more severe secondary effects than the SSRIs.
· Antipsychotics: this medication is useful to reduce the behavior of self-inflicted injury.
· Psychostimulant: used to reduce hyperactivity in people with autism.
· Anxiolytics: reduce the anxiety and panic disorders.
Secretin: it is a hormone produced in the small intestine that assists in digestion. The use of this hormone has been proposed as a treatment for Autism. However significant improvements in symptoms have not been demonstrated.
Other therapies
· Acupuncture
· Art Therapy
· Auditory interaction training
· Alternate communication
· Chelation Therapy
· Cognitive Rehabilitation
· Craniosacral Therapy
· Diet and Nutritional Intervention
· Feedback
· Equestrian Therapy
· Facilitated Communication
· Hyperbaric Oxygen Therapy
· Immunoglobulin
· Music Therapy
· Recreational Therapy
· Sensorial Integrated Treatment
The objective of this evidence review is focused on Autism Spectrum Disorders, treatment and best recommendations.
Triple - S will cover for payment the following services as medically necessary in the evaluation of a known or suspected ASD case:
· Audiological Evaluation
· Behavior Evaluation including psychiatric test
· Electroencephalograms when seizure states are suspected
· Speech and language evaluation by a speech pathologist
· Lead screening
· Medical evaluation including history and physical exam
· Specific screening for Autism
· Neuroimaging studies when the child is a candidate for surgical intervention such as surgery for epilepsy
· Occupational therapy and/or physical therapy when sensory motor deficiencies or motor planning is present
· Sensorial Integrated Treatment
· Quantitative testing for amino acids to determine phenylketonuria
Triple - S will cover for payment these services when any of the following criteria is met:
· Loss of language or social skills at any age
· Absence of babbling by 12 months of age
· Absence of gestures (pointing) by 12 months of age
· Absence of pronouncing ONE word by 16 months of age
· Absence of pronouncing TWO words in a phrase by 24 months of age
Triple-S will cover for payment behavioral treatment in cases of ASD when all of the following criteria are met:
· Criteria for ASD according to “Diagnostic and Statistical Manual of Mental Health Disorders” Fifth Edition, Text Revision (DSM-V-TR).
· Services are appropriate in type, frequency, extent, site and duration
· Services are provided by a professional staff in the behavior area
· When it is expected that the therapy produces a measurable improvement
Triple-S will cover for payment, genetic testing for the following situations:
· Genetic testing for mutations in the FMR1gene when the Fragile-X syndrome is suspected in presence of dysmorphologic characteristics or mental retardation.
· Genetic testing for mutations in the MECP2 gene when presence of Rett’s syndrome is suspected.
· Pre-pregnancy genetic testing to determine presence of a carrier when there is positive family history of the Fragile-X syndrome or Rett's syndrome in a relative of first or second line of consanguinity.
· Prenatal tests to the fetus (amniocentesis or biopsy of the chorionic villus sampling (CVS) when any parent is a known carrier of the FMR1 or MECP2 genes.
As expressed in the Law for the Protection, Security, Inclusion, Well-Being, and Comprehensive Development of Persons with Autism Spectrum Disorders , Law No. 163 - 2024, cognitive rehabilitation is considered for payment under autism conditions.
Triple-S does not consider for payment:
· Allergy tests
· Antibodies tests for “Celiac Disease”
· Peroxidase erythrocyte glutathione studies
· Evoked potentials
· Hair analysis
· Heavy metals tests
· Immunological or neurochemical tests
· Intestinal permeability tests
· Magnetoencephalography
· Vitamin levels
· Lactate and pyruvate tests
· Tests of Chelation for mercury
· Urinary tests for peptides
Triple-S does not consider for payment the following therapies:
· Acupuncture
· Art Therapy
· Auditory interaction training
· Alternate communication
· Chelation Therapy
· Craniosacral Therapy
· Dietary and Nutritional Intervention
· Feedback
· Equestrian Therapy
· Facilitated Communication
· Hyperbaric Oxygen Therapy
· Immunoglobulin
· Music therapy
· Recreational Therapy
· Secretin Infusion
· Vision Therapy
In the fifth edition of the "Diagnostic and Statistical Manual of Mental Disorders" (DSM-V-TR) pervasive development disorder includes: Autistic Disorders, Rett's Syndrome, Childhood Disintegrative Disorders, Asperger's Syndrome, Nonspecific or Atypical Autism Pervasive Developmental Disorders. The autistic spectrum includes the following:
• Autistic Disorder F84.0: this condition refers to the classic autism that includes measurable deficits in:
o Social interaction
o Language, communication and games
o Deficits that manifest as stereotypes such as: persistent repetition of words, posture or movement without meaning, preserve a narrow range of interests and activities.
• Asperger’s Syndrome F84.5: this disorder is not associated with the significant delay in cognitive development or to difficulty with social interactions, or a small range of interests, they preserve well the fluency of the language without a lag in it.
• Non-specific pervasive developmental disorder F84.0: this disorder includes children with autistic behavior but who do not meet the criteria of other autistic spectrum disorders.
• Disintegrative Disorder (Heller's syndrome) F84.3: this disorder includes previously normal children who manifest a massive regression between two and ten years of age resulting in a severe acquired autism with loss of cognitive skills.
• Rett's Syndrome F84.2: this is a specific disorder limited to girls with acquired microcephaly, childhood regression, loss in the use of the hands, stereotypical movements of the hands, severe retardation and others neurological problems.
When a child has symptoms of autism or "Asperger's" but does not meet the criteria for either of these, the diagnosis is described as pervasive development disorder not specified (PDD-NOS), also known as atypical development or atypical autism pervasive disorder. All these disorders are characterized by varying degrees of difficulty in communication skills, social interaction, and stereotypes patterns, restricted or repetitive of language and behavior.
BlueCard/National Account Issues
N/A
Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.
Autism Spectrum Disorders (ASD) are a group of complex disorders which are also referred to as pervasive developmental disorders. These disorders range from a condition known as Autism or "Asperger's" Syndrome Autistic Disorder. Other two autism spectrum disorders are Rett's disorder (Rett's syndrome) and the childhood disintegration disorder.
In February 2007 the Center for Disease Control and Prevention (CDC) published data related to the prevalence of ASD. The CDC estimates that 2 to 6 per 1000 or 1 in 150 children has ASD. The risk is 3 or 4 times higher in males than in females. This is a prevalence higher than the previously shown.
The etiology of ASD is unknown, but it is apparently associated with hereditary conditions. This etiology has been identified for between 15% to 20% of individuals with autism, in the rest the cause continues to be unknown.
The autism has been associated with other medical conditions. Some disorders are associated with ASD:
· Epilepsy or seizure disorders: approximately one-third of people with autism show some sign of seizure disorder.
· Tuberous Sclerosis: approximately 6% of people with autism have this multisystem genetic disease that is characterized by tumors in the brain and other vital organs. Symptoms include seizures, behavior problems, abnormalities of the skin, kidney disease and late development.
· Fragile X Syndrome: 2.1% have this condition that is the most common cause of hereditary mental retardation.
· Mental retardation: 25% of people with autism have some degree of mental retardation.
Evaluation
Indications for an immediate evaluation of ASD includes:
· No babbling or pointing or other types of gestures for the age of 12 months.
· No pronunciation of simple words for the age of 16 months.
· No pronunciation of two-word phrases for the age of 24 months.
· Loss of language or social skills in the pre-adolescence.
The ASD assessment requires an approach by a multidisciplinary team for evaluation of the difficulties that are present. This team includes: Pediatrician, Psychiatrist, Psychologist, Neurologist, Speech Therapist, Occupational Therapist and Social Worker. There is no specific test to confirm the diagnosis of ASD (Volkmar, et al., 1999;) Tuchman, 2003; Filipek, et al., 2000/2006/2010). This evaluation must include the following:
· Clinical history: a report of parents that includes family history, pregnancies and history of neonatal development of the child, should be included. For this standardized questionnaire are used.
This evaluation must include the following: (Volkmar, et al., 1999;) Tuchman, 2003; Filipek, et al., 2000/2006/2010):
· Audiological evaluation
· Evaluation of communication: this must be done by a speech pathologist.
· Occupational evaluation by a physical or occupational therapist: they will evaluate motor impairments, motor or sensory planning and any present dysfunction.
· Screening for lead, particularly if there is pica.
· Screening for magnesium
· Cognitive assessment
The consensus is that the following tests are not necessary for the evaluation of ASD however they can be considered appropriate in the assessment of associated conditions:
· Genetic or chromosomal tests can detect a syndromic condition such as fragile-x or another genetic etiology.
· Metabolic tests
· Neuroimaging studies are indicated only if the child is a candidate for specific interventions (surgery for epilepsy)
· Electroencephalography can be performed if convulsive states are suspected.
The American Academy of Neurology (AAN) and the Child Neurology Society (CNS) have prepared parameters for the screening and diagnosis of autism based on medical evidence. These parameters include the following instruments for the evaluation that can be used in the evaluation process (Filipek et al., 2000/2006/2010):
· The Ages and Stages Questionnaire
· The BRIGNACE® screens
· The Child Development Inventories
· The Parents ‘Evaluation of Developmental Status
The AAN / CNS have developed parameters which indicate that every child that fails a routine development assessment must be screened for autism. These parameters must include the following tools (Filipek et al., 2000/2006/2010):
· Checklist for autism in children who begin to walk: this test is used for children who are 18 months of age.
· Questionnaire for autism screening: this test is used for children older than 4 years of age.
The parameters of practice of AAN / CNS indicate that the Denver II (previously known as the Denver Developmental Screening Test-Revised) is not recommended as a screening tool for autism (Filipek, et to the., 2000 / 2006 / 2010).
It also points out in the parameters of practice that evidence is insufficient to use other tests such as hair analysis to detect elements, celiac antibodies, allergy testing (particularly meals, for gluten, casein, candida or other fungi), immunological tests to detect neurochemical abnormalities, micronutrients such as levels of vitamins, studies of intestinal permeability, stool analysis, coronary peptides, disorders in the mitochondria (including lactates and pyruvate), thyroid function tests and studies of glutathione peroxidase in erythrocytes (Filipek et al., 2000/2006/2010).
These parameters of practice indicate that the recording of evoked potentials and magnetoencelography at present are research tools and that the evidence appears to have no clinical utility.
The American Academy of Pediatrics (AAP) recommends the evaluation of children for ASD and risk factors that must be observed in every preventive visit during childhood. These screening tools include clinical observation of the child, the behavior and aspects that parents have not evaluated. They also point out that a specific screening of autism should be at 18 months of age.
It has been suggested that neuropsychological tests must be used in the evaluation of ASD to help in the process of educational planning. The medical necessity to use neuropsychological tests in the evaluation and management of ASD is not documented in the medical literature. The use of these neuropsychological tests in this scenario is primarily for educational purposes and not medically necessary in the evaluation and management of these conditions.
There is insufficient evidence to demonstrate that tests of chelation for mercury in the evaluation of ASD have some value. There has been interest shown in seeing the relationship of heavy metals in particular mercury and the etiology of ASD. Tests for heavy metals (arsenic, barium, beryllium, bismuth, antimony and mercury) are not recommended in the medical literature.
Diagnosis Criteria for Autistic Disorder F84. 0
A. A total of 6 or more criteria of 1), 2), and 3), with at least 2 of 1 and 1 of every 1 of 2 and 3.
1) Qualitative difficulty in the social interaction manifested by at least 2 of the following:
a. Marked difficulty on the use of multiple nonverbal behaviors such as look eye to eye, facial expression, body posture and gestures that regulate social interaction.
b. Failure in developing relations with classmates appropriate for level of development.
c. Failure to interact tastes, interests, or achievements with other people in a spontaneous way.
d. Lack of emotional or social reciprocity.
2) Qualitative difficulty in communication manifested by at least 1 of the following:
a. Lack of development or late development of verbal language.
b. In individuals with appropriate verbalization and marked difficulty in the ability to initiate or maintain a conversation with others.
c. Repetitive use of stereotyped language or idiosyncratic language.
d. Lack of variety of a spontaneous social initiative appropriate to their level of development.
3) Patterns of behavior, interests, and stereotyped or repetitive activities that manifest themselves with at least one of the following:
a. Constant concern with one or more of the unlimited stereotyped patterns of interest that is abnormal in intensity or focus.
b. Inflexible adhesion to specific rituals or non-functional routines.
c. Stereotyped and repetitive mannerisms (motor) (movements with the hands, the fingers or complex movements with the body).
d. Persistent concern with parts of objects.
B. Abnormal delay or functioning in at least one of the following areas, with a start before 3 years of age:
1) Social interaction
2) Language used in social communication
3) Symbolic or imaginary games
C. The problem cannot be defined better by Rett's syndrome or Childhood Disintegration Disorder.
Diagnosis Criteria for Rett's Syndrome F84.2
A. All of the following:
1) A normal development and perinatal apparently normal
2) A psychomotor development apparently normal during the first 5 months of life.
3) A normal head circumference at birth.
B. Appearance of all of the following after a period of normal development:
1) Deceleration in the growth of the head between 5 and 48 months of age.
2) Loss of the manual skills between 5 and 30 months of age with the subsequent development of stereotyped movements of the hand (movements of the fingers or applause).
3) Loss of previously acquired social relations.
4) Emergence of uncoordinated movements in the body or when moving.
5) Severe difficulty in the development of the language with a severe psychomotor retardation.
Diagnosis Criteria for the Childhood Disintegration Disorder F84.3
A. It is characterized because there is an apparent normal development during the first 2 years of life that are manifested with a verbal and nonverbal communication appropriate for the age, normal social relations, games and a capacity of adaptation.
B. Significant loss of the previously acquired skills (before 10 years of age) in at least two of the following areas:
1) Receptive or expressive language
2) Adaptive behavior or social skills
3) Bladder or bowel control
4) Games
5) Motor skills
C. Anomalies in the functioning of at least two of the following areas:
1) Qualitative difficulty in social interaction (difficulty in non-verbal behavior, difficulty developing relationships with their peers, absence or lack of social or emotional reciprocity).
2) Qualitative difficulty in communication (inability to initiate or maintain a conversation, repetitive and stereotypical language, loss of language).
3) Repetitive and stereotyped behavior patterns, repetitive activities including motor and stereotyped mannerisms.
D. The problem cannot be defined better by other pervasive development disorder.
Diagnosis Criteria for the Asperger's Syndrome F84.5
A. Qualitative difficulty in social interaction manifested by at least two of the following:
a. Marked difficulty in the use of multiple nonverbal behaviors such as look eye to eye, facial expression, body posture and gestures that regulate social interaction.
b. Failure to develop relationships with peers appropriate to development level.
c. Failure to interact tastes, interests, or achievements with other people in a spontaneous way.
d. Lack of emotional or social reciprocity.
B. Patterns of behavior, interests, and stereotyped or repetitive activities that manifest with at least one of the following:
1) Constant concern with one or more of the unlimited stereotyped patterns of interest that is abnormal in intensity or focus.
2) Inflexible adhesion to specific rituals or non-functional routines.
3) Stereotyped and repetitive mannerisms (motor) (movements with the hands, the fingers or complex movements with the body).
4) Persistent concern with parts of objects.
C. The disorder produces a significant difficulty in the social, occupational aspect or other important functioning areas.
D. Usually there are no problems in the development of the language.
E. Generally, there are no problems in the cognitive development or in the development of skills of self- help or in the curiosities of childhood.
F. The problem cannot be defined best by another pervasive development disorder or schizophrenia.
The cause of the autism is not known, but apparently there are a great variety of genetic and not genetic factors. It has been estimated that the risk of recurrence a brother is 5%. Although it has been thought that there is a genetic cause, the identity and the number of genes involved is not known. Researchers indicate that there is not a simple biological or clinical marker for the autism or that only one gene is responsible for the condition.
The great phenotypic variability of ASD is due to the interaction of multiple genes in the individual genome and the existence of different genes and combination of genes that exist in those people affected. The exception is the Rett's disorder where mutations in the gene MECP2 are thought to be responsible for the majority of the cases of this condition.
For the majority of the patients, genetic testing will give low results unless they are performed in people with family history, medical history of presence of mental retardation or other dysmorphic findings that suggest the presence of the condition. Genetic counseling should help parents and children to establish an estimate of risk of recurrence.
The presence of dysmorphic characteristics or another specific finding may suggest a genetic screening for hereditary metabolic disorders or a chromosomal analysis.
· Rett's Disorder: this condition is one of the disorders on the autism spectrum. Molecular testing for mutations in MECP2 are clinically available. This disorder is inherited from dominant manner and associated with sex. It usually appears as a mutation of novo in the child or as inherited from a condition which induces mutation in one of the parents, which in turn have mosaicism.
· Fragile-X Syndrome: is the most common cause of inherited mental retardation and is due to a mutation in the FMR1 gene is also associated with sex. Mutations in the FMR1 gene are responsible for 98% of the cases of Fragile-X syndrome. Approximately 50% of the children with this syndrome have autistic behavior.
*Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Severity levels
The DSM - 5 recommends that in the evaluation of ASD the severity level is specified, recognizing that severity can vary in context and time. Severity must be assessed separately for each domain.
Social communication / interaction
§ Level 1 (Requires support) - Noticeable impairment without support; difficulty in initial social interaction; failed or atypical response to social situations; failure in conversation; attempts of establishing friendship fail.
§ Level 2 (Requires substantial support) - Marked deficit in communication; difficulty even with support; abnormal or reduced response to social situations
§ Level 3 (Requires extreme support) Behavior is obvious even to a casual observer; initiation of social interaction is very limited; response to social situations is minimal or none
Repetitive / Restrictive Behavior
· Level 1 (Requires support) Behavior interferes with function significantly; difficulty in changing activities; independence limited by problems of organization and planning.
· Level 2 (Requires substantial support) Behavior is obvious to the casual observer; behavior interferes with function in various situations of distress, /difficulty changing focus or action.
· Level 3 (Requires extreme support) Behavior interferes in a marked way in the function in all the spheres; extreme difficulty to adapt to change; great difficulty changing focus or action.
The DSM recommends that physicians specify the presence or absence of the following associated conditions:
· Intellectual difficulty; to diagnose comorbidity between autism spectrum disorders and intellectual disability
· Difficulty in language; (for example, simple words, nonverbal language etc.)
· Medical or genetic known conditions; (for example, Epilepsy, Rett syndrome, Down syndrome, etc.)
Other conditions related to neurodevelopment, mental conditions or behavioral disorders.
· Catatonia
Treatment
There are no effective medical interventions that achieve a cure for Autism. However, this condition can be managed through a combination of educational, pharmacological and behavioral interventions. The American Academy of Child and Adolescent Psychiatry (AACAP) proposes that the parameters of treatment must be based on a solid and empirical evidence of high quality.
AACAP guidelines indicate that the educational services include special education, forms of behavior modification and other services. They are the central and integral aspect in the treatment of ASD. Psychosocial intervention includes training to the parents in behavior modification techniques and referral to support groups. They also point out in the literature that there is not a unique approach that is good for all ASD patients.
The deficit in the communication is frequent in ASD and treatment with speech pathologists is considered favorably in the treatment. When these deficits are accompanied or coincide with a difficulty in speaking due to a separate neurological cause, speech therapy may be medically necessary.
Physical therapy and occupational therapy may be necessary in the management of motor deficit if there is potential for functional improvement.
Treatments attempted for this condition include intervention in the behavior, education, medical treatment, adjunctive therapy and alternative medicine. It also includes acupuncture and massage.
· Behavior intervention: some studies suggest that cognitive behavioral therapy interventions are effective in reducing the symptoms of anxiety.
· Educational Intervention: known as Treatment and Education of the Autistic and Communication Related to Handicapped Children (TEACCH). The evidence shows that TEACCH has a very broad base and the educational approach with computer programs are included in this category. The long term results of these studies are insufficient and inconsistent. More studies are necessary.
· Medical intervention: evidence favors the use of medications to modify behavior. The antipsychotic risperidone and aripiprazole have shown improvements in behavior as estimated by parents. Both medications have significant side effects including: weight gain, sedation, and risks of extra pyramidal symptoms.
· Allied Health: studies in this aspect have shown improvements in the acquisition of language through language and communication interventions.
Pharmacological treatment: AACAP guidelines point out that the medications are not specific to Autism and do not treat the heart of the disorder symptoms, however, they are useful for symptoms that interfere with the participation and educational interventions or anxiety situations of the individual. Pharmacological treatment includes:
· Selective Serotonin Reuptake Inhibitors (SSRIs): this is a group of antidepressants to reduce the frequency and intensity of repetitive behaviors, treat irritability and reduce aggressive behavior.
· Tricyclic Agents and antidepressants: can be very effective in some people. Can have more severe secondary effects than the SSRIs.
· Antipsychotics: this medication is useful to reduce the behavior of self-inflicted injury.
· Psychostimulant: used to reduce hyperactivity in people with autism.
· Anxiolytics: reduce the anxiety and panic disorders.
Secretin: it is a hormone produced in the small intestine that assists in digestion. The use of this hormone has been proposed as a treatment for Autism. However significant improvements in symptoms have not been demonstrated.
Other therapies
· Acupuncture
· Art Therapy
· Auditory interaction training
· Alternate communication
· Chelation Therapy
· Cognitive Rehabilitation
· Craniosacral Therapy
· Diet and Nutritional Intervention
· Feedback
· Equestrian Therapy
· Facilitated Communication
· Hyperbaric Oxygen Therapy
· Immunoglobulin
· Music Therapy
· Recreational Therapy
· Sensorial Integrated Treatment
Please refer to the Law for the Protection, Security, Inclusion, Well-Being, and Comprehensive Development of Persons with Autism Spectrum Disorders.Law No. 163 of August 13, 2024
https://bvirtualogp.pr.gov/ogp/Bvirtual/leyesreferencia/PDF/2020/0163-2024.pdf
Population Reference No. 1 Policy Statement
For individuals with Autism Spectrum Disorders (ASD). Interventions of interest are behavioral treatment. Comparators of interests are other alternative therapies. Relevant outcomes include improvement of behavioral and social skills.
| Population Reference No. 1 Policy Statement | [x] MedicallyNecessary | [ ] Investigational | [ ] Not Medically Necessary |
n/a
Practice Guidelines and Position Statements
Sensory Integration Therapy
American Academy of Pediatrics
A 2012 policy statement by the American Academy of Pediatrics (AAP) on SI therapies for children with developmental and behavioral disorders states that “[o]ccupational 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 SIT.17
American Occupational Therapy Association
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.”18
In 2011, AOTA published evidence-based occupational therapy practice guidelines for children and adolescents with challenges in sensory processing and sensory integration.19 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 harm 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).
Auditory Integration Therapy
American Speech-Language-Hearing Association
In 2003, the American Speech-Language-Hearing Association (ASHA) Working Group on Auditory Integration Training issued a report on the topic.20 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.”
American Academy of Pediatrics
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.”21
U.S. Preventive Services Task Force Recommendations
Not applicable.
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.
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| Codes | Number | Description |
|---|---|---|
| CPT | 97151 | Behavior identification assessment, administered by a physician or other qualified health care professional, each 15 minutes of the physician's or other qualified health care professional's time face-to-face with patient and/or guardian(s)/caregiver(s) administering assessments and discussing findings and recommendations, and non-face-to-face analyzing past data, scoring/interpreting the assessment, and preparing the report/treatment plan |
| 97152 | Behavior identification-supporting assessment, administered by one technician under the direction of a physician or other qualified health care professional, face-to-face with the patient, each 15 minutes | |
| 0362T | Behavior identification supporting assessment, each 15 minutes of technicians' time face-to-face with a patient, requiring the following components: administration by the physician or other qualified health care professional who is on site; with the assistance of two or more technicians; for a patient who exhibits destructive behavior; completion in an environment that is customized to the patient's behavior. | |
| 97153 | Adaptive behavior treatment by protocol, administered by technician under the direction of a physician or other qualified health care professional, face-to-face with one patient, each 15 minutes | |
| 97154 | Group adaptive behavior treatment by protocol, administered by technician under the direction of a physician or other qualified health care professional, face-to-face with two or more patients, each 15 minutes | |
| 97155 | Adaptive behavior treatment with protocol modification, administered by physician or other qualified health care professional, which may include simultaneous direction of technician, face-to-face with one patient, each 15 minutes | |
| 97156 | Family adaptive behavior treatment guidance, administered by physician or other qualified health care professional (with or without the patient present), face-to-face with guardian(s)/caregiver(s), each 15 minutes | |
| 97157 | Multiple-family group adaptive behavior treatment guidance, administered by physician or other qualified health care professional (without the patient present), face-to-face with multiple sets of guardians/caregivers, each 15 minutes | |
| 97158 | roup adaptive behavior treatment with protocol modification, administered by physician or other qualified health care professional, face-to-face with multiple patients, each 15 minutes | |
| 0373T | Adaptive behavior treatment with protocol modification, each 15 minutes of technicians' time face-to-face with a patient, requiring the following components: administration by the physician or other qualified health care professional who is on site; with the assistance of two or more technicians; for a patient who exhibits destructive behavior; completion in an environment that is customized to the patient's behavior. | |
| CPT | 81243 | FMR1(Fragile X mental retardation 1) (e.g. fragile X mental retardation) gene analysis; evaluation to detect abnormal (e.g. expanded) alleles (code effective 01/01/2012) |
| 81244 | FMR1(Fragile X mental retardation 1) (e.g. fragile X mental retardation) gene analysis; characterization of alleles (e.g. expanded size and methylation status) (code effective 01/01/2012) | |
| 81302 | MECP2 (methyl CpG protein 2) (e.g. Rett Syndrome) gene analysis; full sequence analysis (code effective 01/01/2012) | |
| 81303 | MECP2 (methyl CpG protein 2) (e.g. Rett Syndrome) gene analysis; known familial variant (code effective 01/01/2012) | |
| 81304 | MECP2 (methyl CpG protein 2) (e.g. Rett Syndrome) gene analysis; duplication/deletion variants (code effective 01/01/2012) | |
| 83655 | Lead | |
| 90791 | Psychiatric diagnostic evaluation | |
| 90792 | Psychiatric diagnostic evaluation with medical services | |
| 92521 | Evaluation of speech fluency (eg, stuttering, cluttering) | |
| 92522 | Evaluation of speech sound production (eg, articulation, phonological process, apraxia, dysarthria | |
| 92523 | With evaluation of language comprehension and expression (eg, receptive and expressive language | |
| 92524 | Behavioral and qualitative analysis of voice and resonance | |
| 95812 | Electroencephalogram (EEG) extended monitoring; 41-60 minutes | |
| 95813 | Electroencephalogram (EEG) extended monitoring; greater than 1 hour | |
| 95816 | Electroencephalogram (EEG); including recording awake and drowsy | |
| 95819 | Electroencephalogram (EEG); including recording awake and asleep | |
| 95827 | Electroencephalogram (EEG); all night recording | |
| 96110 | Developmental screening, with interpretation and report, per standardized instrument form | |
| 96111 | Developmental testing, (includes assessment of motor, language, social, adaptive, and/or cognitive functioning by standardized developmental instruments) with interpretation and report | |
| 97533 | Sensory integrative techniques to enhance sensory processing and promote adaptive responses to environmental demands, direct (one-on-one) patient contact by the provider, each 15 minutes | |
| 97161 | Physical therapy evaluation: low complexity | |
| 97162 | Physical therapy evaluation: moderate complexity | |
| 97163 | Physical therapy evaluation: high complexity | |
| 97165 | Occupational therapy evaluation, low complexity | |
| 97166 | Occupational therapy evaluation, moderate complexity | |
| 97167 | Occupational therapy evaluation, high complexity | |
| HCPCS | E2500 | Speech generating device, digitized speech, using pre-recorded messages, less than or equal to eight minutes recording time |
| E2502 | Speech generating device, digitized speech, using pre-recorded messages, greater than 8 minutes but less than or equal to 20 minutes recording time | |
| E2504 | Speech generating device, digitized speech, using pre-recorded messages, greater than 20 minutes but less than or equal to 40 minutes recording time | |
| E2506 | Speech generating device, digitized speech, using pre-recorded messages, greater than 40 minutes recording time | |
| E2508 | Speech generating device, synthesized speech, requiring message formulation by spelling and access by physical contact with the device | |
| E2510 | Speech generating device, synthesized speech, permitting multiple methods of message formulation and multiple methods of device access | |
| J1561 | Injection, immune globulin, (Gamunex), intravenous, nonlyophilized (e.g., liquid), 500 mg | |
| J1566 | Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg | |
| J1568 | Injection, immune globulin, (Octagam), intravenous, nonlyophilized (e.g., liquid), 500 mg | |
| J1569 | Injection, immune globulin, (Gammagard liquid), intravenous, nonlyophilized, (e.g., liquid), 500 mg | |
| J1572 | Injection, immune globulin, (Flebogamma), intravenous, nonlyophilized (e.g., liquid), 500 mg | |
| ICD-10-CM | F84.0 | Autistic disorder |
| F84.1 | Atypical Autism | |
| F84.2 | Retts Syndrome | |
| F84.3 | Other childhood disintegrative disorder | |
| F84.4 | Overactive disorder assoc w mental retardation or stereotyped movements | |
| F84.5 | Asperger's syndrome | |
| F84.8 | Other pervasive developmental disorders | |
| F84.9 | Pervasive developmental disorder, unspecified |
Some modifiers
| Date | Action | Description |
|---|---|---|
| 11/26/2024 | Review | Policy updated with law change to Law No. 163 of August 13, 2024. Mantains archived status. |
| 11/14/2019 | Annual Review | Policy reviewed at the Advisory Board Committee. No changes on policy statement. |
| 12/28/2018 | Review | Updated CPT codes to 2019 changes |
| 11/14/2018 | Annual Review | New policy format. Policy status changed to archived, updated to DSM-V diagnosis by Advisory Board Committee recommendations. |
| 10/31/16 | ||
| 11/13/15 | ||
| 05/15/15 |
| Applicable Specialties | ||
| Preauthorization required | [ ] Yes | [ ] No |
| Preauthorization requirements | ||
| Place of Service | ||
| Age Limit | ||
| Frequency | ||
| Frequency Limit | ||
| Gender | [ ] Male | [ ] Female |
| [ ] YES | [X] NO |
| Description: | |
| [ ] YES If Yes, describe the comparison between Interqual criteria and this Policy |
[X] NO |
|
DESCRIBE THE COMPARISON BETWEEN INTERQUAL CRITERIA AND THIS POLICY: |
|
|
[X] LOCAL If Local, specify Rationale: |
[ ] BCBSA |
|
SPECIFY RATIONALE: Local policy to compy with Law 163 2024 |
|