CPT 0359T, 0362T, 0363T, 0364T, 0365T, H2014, H0031 - Applied Behavior Analysis

Coding Code Description CPT

0359T Behavior identification assessment – Used for initial evaluation/assessment, initial functional analysis, and periodic functional analysis re-assessments (must be done by a program manager/lead behavioral therapist) Alternate to HCPCS H0031

0362T Exposure behavior follow-up assessment, administered by physician or other qualified health care professional with the assistance of one or more technicians, face-to-face with the patient; first 30 minutes of technician(s) time Alternate to HCPCS H2014

0363T Exposure behavior follow-up assessment, administered by physician or other qualified health care professional with the assistance of one or more technicians, face-to-face with the patient; each additional 30 minutes of technician(s) time Alternate to HCPCS H2014

0364T Adaptive behavior treatment by protocol, administered by technician, face-to-face with one patient; first 30 minutes of technician time Alternate to HCPCS H2014

0365T Adaptive behavior treatment by protocol, administered by technician, face-to-face with one patient; each additional 30 minutes of technician time (List separately in addition to code for primary procedure)

Alternate to HCPCS H2014


0368T Adaptive behavior treatment with protocol modification administered by physician or other qualified health care professional with one patient; first 30 minutes of patient face-to-face time

Alternate to HCPCS H2019

0369T Adaptive behavior treatment with protocol modification administered by physician or other qualified health care professional with one patient; each additional 30 minutes of  patient face-to-face time (List separately in addition to code for primary procedure) Alternate to HCPCS H2019

0370T Family adaptive behavior treatment guidance, administered by physician or other qualified health care professional (without the patient present) Alternate to HCPCS H2019

0372T Adaptive behavior treatment social skills group, administered by physician or other  qualified health care professional face-to-face with multiple patients Alternate to HCPCS H2019

HCPCS

H0031 Mental health assessment – Used for initial evaluation/assessment, initial functional analysis, and periodic functional analysis re-assessments (must be done by a program manager/lead behavioral therapist)

H0032 Mental health service plan development – Used for program development, treatment plan development or revision, data analysis, case review, treatment team conferences, supervision of therapy assistants/paraprofessionals, and for real-time direct communication/coordination with other providers (must be done by a program manager/lead behavioral therapist)

H2014 Skills training and development, per 15 minutes – Used for direct services to member and/or parents (including parent education and training) by therapy assistants/behavioral technicians/paraprofessionals

H2019 Therapeutic behavioral services, per 15 minutes – Used for direct services to member and/or parents (including parent education and training) by program managers/lead behavioral therapists

S5108 Home care training to home care client – Used for direct services to member bytherapy assistants/behavioral technicians/paraprofessionals

S5109 Home care training to home care client – Used for direct services to member by therapy assistants/behavioral technicians/paraprofessionals

S5110 Home care training ,family -- Used for direct services to parents and/or family (including parent education and training) by therapy assistants/behavioral technicians/paraprofessionals S5111 Home care training ,family -- Used for direct services to parents and/or family (including parent education and training) by therapy assistants/behavioral





Introduction

Applied behavior analysis (ABA) applies the principles of how people learn and their motivations to change behavior. The idea behind ABA is that behaviors that are rewarded will increase and behaviors that are not rewarded will decrease and eventually stop. There are several different ABA techniques. Generally, each focuses on what happens before a behavior occurs and what happens after. ABA has been used for people with autism to try to increase language and communication, enhance attention and focus, and help with social skills and memory. This policy describes when ABA may be considered medically necessary. It also discusses the providers the plan covers for ABA services, and the usual number of hours covered during ABA evaluation and therapy.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Service Medical Necessity

Psychotherapy sessions Psychotherapy sessions that include applied behavior analysis  interventions, that are offered separately from a comprehensive, intensive program using a program manager and therapists and/or therapy assistants, may be considered medically necessary for the treatment of covered mental disorders when:

* Provided by state-licensed clinicians practicing within the legal scope of their licensure AND

* The services are consistent with psychotherapy sessions designated by current CPT terminology.

Applied Behavior Analysis (ABA)

Treatment that consists of Applied Behavior Analysis (ABA) provided several hours daily on treatment days and utilizing a program manager, lead therapist, or supervising clinician plus therapists or therapy assistants may be considered medically necessary when the following criteria are met:

* The member has been diagnosed with Autism Spectrum Disorder (DSM-5 299.00; ICD-9 299.0, 299.00, 299.01, 299.1, 299.10, 299.11, 299.8, 299.80, 299.81, 299.9, 299.90, or 299.91; DSM-IV 299.00, 299.10, or 299.80; ICD-10 F84, F84.0, F84.2, F84.3, F84.5, F84.8, or F84.9) by a psychiatrist, psychologist, neurologist, or developmental pediatrician. The diagnosis has been validated by a documented comprehensive assessment demonstrating the presence of DSM-5 diagnostic criteria if the diagnosis was made after the release of DSM-5, or demonstrating the presence of DSM-IV diagnostic criteria if the diagnosis was made prior to the release of DSM-5. ABA is considered to be not medically necessary for any other conditions.

* The Autism Spectrum Disorder (ASD) is adversely impacting the member’s development, communication, social interactions, or behavior such that the member is unable to adequately participate in age-appropriate home, school, or community activities, or the member is a safety risk to self, others, or property.

* The services provided are Comprehensive ABA or Focused ABA as described by the Behavior Analyst Certification Board.


Medical Necessity Comprehensive ABA, such as Early Intensive Behavioral

Intervention, addresses multiple domains simultaneously with the goal of bringing functioning to or near levels typical for chronological age. Focused ABA has a goal of addressing a limited number of behavioral or skill development targets. * An individualized treatment plan is developed and documented prior to or within 30 days of beginning ABA. The treatment plan is based on a comprehensive assessment, often called a functional analysis or Functional Behavioral Analysis that was conducted prior to, but no earlier than within 6 months of, the initiation of ABA. The treatment plan includes the following elements:

o Verification of ASD diagnosis by DSM-5 or DSM-IV criteria.

o Identification and detailed description of targeted symptoms and behaviors. Targeted symptoms and behaviors must be those which are preventing the member from adequately participating in age-appropriate home, school, or community activities, or that are presenting a safety risk to self, others, or property.

o Objective baseline measurements of each targeted symptom and behavior via measurements that are administered by or approved by the program manager/lead behavioral therapist (defined below).

o Detailed description of treatment modality or modalities and interventions for each targeted symptom and behavior.

o Treatment goals and measures of progress for each targeted symptom and behavior, with estimated timeframes for achieving the goals.

o Inclusion of parents (or active caretakers or legal guardians when appropriate); specifically, detailed description of interventions with parents, including as appropriate parental education, training, coaching, support, overall goals for parents, and plan for transferring interventions with member/identified patient to parents.

o Plan for communication and coordination with other providers and agencies as appropriate, including day care, school, and other health care providers.


o Total number of days per week and hours per day of direct services to the member/identified patient and of services to parents. Total number of hours per week of supervision of therapy assistants. Total number of hours per month of program development, treatment plan development, and case review.

o Measurable criteria for completing treatment, with projected plan for continued care after discharge from ABA.

* Evaluation of progress:

o Data on targeted symptoms and behaviors is collected by direct therapy providers during each ABA session. The program manager/lead behavioral therapist collates and evaluates the data from all sessions at least once/week, and summarizes progress on each targeted symptom and behavior at least once every six months.

* Progress is assessed and documented for each targeted symptom and behavior, including progress towards the defined goals, and including the same modes of measurement that were utilized for baseline measurements of specific symptoms and behaviors.

* When goals have been achieved, either new goals should be identified that are based on targeted symptoms and behaviors which are preventing the member from adequately participating in ageappropriate home, school, or community activities, or that are presenting a safety risk to self, others, or property; or, the treatment plan should be revised to include a transition to less intensive interventions.

* When there has been inadequate progress re: targeted symptoms and behaviors, or no demonstrable progress within a six month period, or specific goals have not been achieved within the estimated timeframes, there should be an assessment of the reasons for inadequate progress or not meeting the goals, and treatment interventions should be modified or changed in order to attempt to achieve adequate progress, or a change in providers should take place, whichever is appropriate.


* When there is continued absence of adequate improvement or when progress plateaus, and there is no reasonable expectation of further progress, the treatment plan should be revised to reflect a planned discontinuation of ABA, and referral to other resources as appropriate, allowing for a brief period of time for termination with the member and parents.


Applied Behavior Analysis (ABA) Service Providers

Applied Behavior Analysis (ABA) services are either provided by, or are under thesupervision of, a clinician (often referred to as the program manager or lead behavioral therapist) who is one of the following:

* A Board Certified Behavior Analyst (BCBA), certified by the Behavior Analyst Certification Board, and state-licensed or state-certified in states that require state licensure or state certification for behavior analysts.
* Any other state-licensed Behavior Analyst.
* A state-licensed physician who is a psychiatrist, developmental pediatrician, or pediatric neurologist.
* A state-licensed psychiatric advanced nurse practitioner/advanced registered nurse practitioner.
* A state-licensed psychologist.
* A state-licensed Master’s level mental health clinician (eg, licensed clinical social worker, licensed marriage and family counselor, licensed mental health counselor).
* A state-licensed occupational therapist or speech therapist.
* Any other provider whose legally-permitted scope of licensure includes behavior analysis

Alternately, in Washington State, ABA services may be provided by an agency that is licensed by the Department of Social and Health Services, Division of Behavioral Health Resources as a Community Mental Health Agency or as a Licensed Behavioral Health Agency, and is also certified by the Department of Social and Health Services, Division of Behavioral Health Resources to deliver ABA services. The agency must meet all requirements of, and must deliver ABA services in full compliance with, WAC 388-865-0469. In other states that specifically license agencies for ABA, ABA services may be provided by an agency that is so licensed.

When direct services to the member/identified patient and parents are provided by individuals who are not BCBAs or one of the licensed health care professionals listed above (often referred to as therapy assistants, behavioral technicians, or paraprofessionals), the therapy assistants/behavioral technicians/paraprofessionals receive weekly clinical supervision from the program manager/lead behavioral therapist as follows for each patient: generally two hours for every 10 hours of direct service provision, with a minimum of two hours weekly when direct service provision is 10 hours per week or less. Supervision may need to be temporarily increased to meet individual patient needs at certain times in treatment, eg, a significant change in response to treatment, or a significant increase in clinical complexity. Supervision may be conducted entirely in-person, or may be a combination of in-person and remote supervision, but some portion of the supervision (no specific time amount is specified) should be conducted in-person. Some supervisory time (no specific time amount is specified) should be utilized for direct observation of direct service provision by the therapy assistants/behavioral technicians/paraprofessionals. In addition, the program manager/lead behavioral therapist conducts a case review and treatment plan review with the therapy assistants/behavioral technicians/paraprofessionals at least once/month. Although some states are licensing therapy assistants/behavioral technicians, these requirements apply to all therapy assistants/behavioral technicians/paraprofessionals regardless of licensure status.

Therapy assistants, behavioral technicians, or paraprofessionals must be state registered,certified, or licensed in states that require state registration, certification, or licensure for those practitioners.

Board Certified assistant Behavior Analysts (BCaBAs) or state-licensed Assistant Behavior Analysts may function as program managers/lead behavioral therapists only in states in which state law or regulation stipulates that such functioning is in the legally-permitted scope of practice of BCaBAs or licensed assistant behavior analysts. Board Certified assistant Behavior Analysts or state-licensed Assistant Behavior Analysts may not provide ABA treatment services without supervision by a Board Certified Behavior Analyst, Licensed Behavior Analyst, or other higher-level licensed provider as permitted under state law or regulation.

Direct treatment services provided by Board Certified assistant Behavior Analysts and statelicensed Assistant Behavior Analysts are considered to be equivalent to services provided by therapy assistants/behavioral technicians/paraprofessionals.

Applied Behavior Analysis (ABA) Service Providers

Supervision of ABA programs and of clinicians providing direct treatment services must be provided by licensed behavior analysts in states in which state law or regulation stipulates that only licensed behavior analysts are permitted to provide ABA supervision, or by licensed behavior analysts or licensed assistant behavior analysts in states in which state law or regulation stipulates that only licensed behavior analysts or licensed assistant behavior analysts are permitted to provide ABA supervision (see next paragraph).

Licensed assistant behavior analysts may function as program managers/lead behavioral therapists and provide supervision to therapy assistants, behavioral technicians, or paraprofessionals who are providing direct treatment services, in states in which state law or regulation stipulates that supervision of therapy assistants, behavioral technicians, or paraprofessionals is in the legally-permitted scope of practice of licensed assistant behavior analysts. When a licensed assistant behavior analyst provides supervision to therapy assistants, behavioral technicians, or paraprofessionals, then supervision of the licensed assistant behavior analyst by a licensed behavior analyst, a BCBA, or other licensed clinician, although required, is considered to be a component of the licensed assistant behavior analyst‘s training and therefore not a medically necessary component of the treatment program.

Board Certified assistant Behavior Analysts must be state certified or licensed in states that require certification or licensure for BCaBAs.

After diagnosis and referral for ABA, 6-10 hours is usually sufficient for the initial evaluation/assessment for ABA and initial treatment planning by a program manager/lead behavioral therapist if focused ABA is planned. However, for Comprehensive ABA, more complex cases, or cases in which a complete functional analysis is needed, may require up to 15-20 hours for the initial assessment and treatment planning. The assessment may include time-limited observation in the school setting when behavioral or other difficulties that are manifestations of the individual’s Autism Spectrum Disorder are evident and problematic in the school setting. Following the initial evaluation/assessment, 20-40 hours total per week is the usual range of services for Comprehensive ABA, including direct services to member/identified patient and/or parents by program manager/lead behavioral therapist and/or therapy assistants/behavioral technicians/paraprofessionals, program development, treatment plan development, case review, and supervision. Fewer hours are required for Focused ABA. There is no evidence in the published literature to support more than 40 hours per week under any circumstances. Direct services to the member/identified patient are generally provided one-on-one or with parents present, most often in the home setting bu  also in community settings depending on the member/identified patient’s needs and the settings where significant difficulties occur. Social skills groups may be appropriate as a component of a member’s overall ABA program.

Functional analysis re-assessments, when determined to be appropriate, are generally conducted once every 6 to 12 months. The re-assessments may include time-limited  observation in the school setting when behavioral or other difficulties that are manifestations of the individual’s Autism Spectrum Disorder continue to be evident and problematic in the school setting.


technicians/paraprofessionals

Related Information Benefit Application


Except when otherwise directed by specific health plan stipulations (ie, member contracts or summary plan descriptions), covered providers for ABA for Autism Spectrum Disorders are those which are indicated within the Applied Behavior Analysis (ABA) Service Providers section above. Services provided by unlicensed individuals, including therapy assistants/behavioral technicians/paraprofessionals and BCBAs that are not state-licensed, are covered only for the provision of ABA for Autism Spectrum Disorders. Except when otherwise directed by specific health plan stipulations (ie, member contracts or summary plan descriptions), covered services for ABA for Autism Spectrum Disorders are those which are listed in the Coding section above.

Except when otherwise directed by specific health plans, in-network providers of ABA for Autism Spectrum Disorders must use the codes listed in the Coding section above in order to be reimbursed for ABA services.

Group treatment is covered only for social skills groups, and only when conducted by program managers/lead behavioral therapists, not when conducted by therapy assistants/behavioral technicians/paraprofessionals. Group treatment other than social skills groups is considered to be not medically necessary because there is no credible scientific evidence that group treatment other than social skills therapy is an effective component of ABA for the treatment of ASD. Social skills groups in excess of two sessions per day are considered to be not medically necessary. All credible studies demonstrating the effectiveness of ABA have been conducted with ABA consisting predominantly of individual and family treatment with minimal group treatment, at most one to two social skills group sessions per week.

Individual treatment when the member is in a group setting, as distinct from group treatment, is covered only when the clinician is working exclusively with the member for the entire time that the member is in the group setting.


Except when otherwise directed by specific health plan stipulations, program development, treatment plan development and revision, data analysis, case review, supervision of therapy assistants/behavioral technicians/paraprofessionals, and real-time direct communication/coordination with other providers are covered services as part of the provision of ABA for Autism Spectrum Disorders. Program development, treatment plan development and revision, data analysis, case review, supervision of therapy assistants/behavioral technicians/paraprofessionals, and real-time direct communication/coordination with other providers are covered only for program managers/lead behavioral therapists, not for therapy assistants/behavioral technicians/paraprofessionals.

Team meetings are covered only (1) when they are specifically for treatment plan development or revision or case review for one specific patient, or (2) when meeting with the parents of one specific patient to discuss the treatment of that patient.

Charting data or plotting graphs, as distinct from actual analysis of data, are not covered.

Therapy assistants’/behavioral technicians’/paraprofessionals’ time in supervision is not a covered service because the service being provided (supervision) is being delivered by the program manager/lead behavioral therapist, not by the therapy assistant(s)/behavioral technician(s)/paraprofessional(s). Exception: When the program manager/lead behavioral therapist is supervising the therapy assistant/behavioral technician/paraprofessional while the  latter is providing covered direct treatment services, then for only the time during which that istaking place, both the supervision by the program manager/lead behavioral therapist and the direct treatment services by the therapy assistant/behavioral technician/paraprofessional are covered services.

Except when otherwise directed by specific health plans, services not listed in the Coding section above are not covered services for ABA for Autism Spectrum Disorders. Some portion of the direct service provision (no specific time amount is specified) may take place in the school setting when behavioral or other difficulties that are manifestations of the individual’s Autism Spectrum Disorder are evident and problematic in the school setting. Direct service provision in the school setting must consist entirely of bona-fide ABA treatment activities; the ABA clinician may not be utilized as a classroom aide for the patient, as a 1:1 teacher for the patient, or in any other capacity that is a function of and the responsibility of the school system.

Schools and school programs for individuals with Autism Spectrum Disorder, and tuition for specialized schools for individuals with Autism Spectrum Disorder, are non-covered activities and services because schools are not covered facility types, and educational therapy, educational services, and services that are the responsibility of school districts, and should therefore be provided by school staff, are specifically excluded from coverage (except if

otherwise directed by specific health plan stipulations). Although such schools or programs may claim that they consist of ABA services, significant portions of the school day or programs are for educational and other activities that are not ABA services. Coverage is allowed for direct service provision in the school setting that consists entirely of bona-fide ABA treatment activities, delivered by covered ABA providers.

Camps, camp programs, day camps, school break camps, summer camps, and any similar activities are non-covered activities because camping, camp programs, recreational programs, and recreational programs are specifically excluded from coverage (except if otherwise directed by specific health plan stipulations). Although such programs may claim that they consist of ABA services, significant portions of the programs are for recreational purposes (not covered), and are for the purpose of providing professional assistance so that youngsters with ASD can partake of normal recreational camp activities, which does not constitute the provision of treatment. In addition, the goals and interventions in these programs are not a continuation of the same goals and interventions that were in place prior to the camp programs, do not continue as part of the patients’ ABA treatment after the camp programs, and generally do not target specific individualized impairments that were being targeted for treatment prior to the camp programs and that will continue to be being targeted for treatment after the camp programs, ie, the goals, interventions, and targeted impairments are not components of patients’ ongoing ABA treatment plans and services. Also, although 1:1 direct treatment services constitute the core component of and the majority of time for ABA, these program provide little or no direct treatment services.

Direct service provision by telehealth modalities, including to parents or family members, is considered to be not medically necessary because there is no credible scientific evidence that the provision of ABA by telehealth modalities is effective or safe. All credible studies demonstrating that ABA is effective and safe have been conducted with in-person evaluations and intensive in-person direct treatment services. The following are considered to be unnecessary duplication of services and therefore not medically necessary in the provision of ABA services:

* More than one program manager/lead behavioral therapist for a member/identified patient at any one time.

* More than one provider group/clinic/agency/organization providing ABA services for a member/identified patient at any one time.

* More than one clinician (program managers/lead behavioral therapists, or therapy assistants/behavioral technicians/paraprofessionals, or program manager/lead behavioral therapist and therapy assistant/behavioral technician/paraprofessional) providing direct (ABA) treatment services to the same identified patient at the same time. The provision of ABA treatment and a different type of treatment (eg, ABA and speech therapy) to the same identified patient at the same time is considered to be not medically necessary. Individuals with ASD cannot adequately focus on and engage in two different treatment modalities simultaneously.

With the exception of social skills groups, the provision of ABA direct treatment services to more  than one identified patient in the same treatment session is considered to be not medically necessary. There is no established clinical need for or advantage to more than one patient in a  treatment session other than social skills groups. (This does not apply to family therapy, or to collateral sessions with a parent or parents, in which or for which there is only one identified patient.) However, this does apply to treating siblings with the exception of bona-fide family therapy sessions or social skills groups (the latter are expected to include other patients, not just siblings), the provision of ABA direct treatment services to siblings together is considered to be not medically necessary.

Activities and therapy modalities that do not constitute behavioral assessments and interventions utilizing applied behavior analysis techniques are considered to not constitute ABA services, and are therefore either non-covered services if listed as member contract exclusions, or are otherwise considered to be not medically necessary. Examples include (but are not limited to):

* Training of therapy assistants/behavioral technicians/paraprofessionals (as distinct from supervision)

* Preparation work prior to the provision of services

* Accompanying the member/identified patient to appointments or activities outside of the home (eg, recreational activities, eating out, shopping, play activities, medical appointments), except when the member/identified patient has demonstrated a pattern of significant behavioral difficulties during specific activities, , in which case the clinician is present to actively provide treatment, not to just supervise, control, or contain the member/identified patient

* Transporting the member/identified patient in lieu of parental/other family member transport, except when the member/identified patient has demonstrated a pattern of significant behavioral difficulties during transport, in which case transport is still provided by parent/other family member, and the clinician is present to actively provide treatment to the

member/identified patient during transport, not to just supervise, control, or contain the member/identified patient

* Assisting the member with academic work or functioning as a tutor, except when the member has demonstrated a pattern of significant behavioral difficulties during school work

* Functioning as an educational or other aide for the member/identified patient in school

* Provision of services that are part of an IEP and therefore should be provided by school personnel, or other services that schools are obligated to provide

* Provider doing house work or chores, or assisting the member/identified patient with house work or chores, except when the member has demonstrated a pattern of significant behavioral difficulties during specific house work or chores, or acquiring the skills to do specific house work or chores is part of the ABA treatment plan for the member/identified patient

* Provider travel time
* Transporting parents or non-patient family members
* Babysitting
* Respite for parents/family members
* Provider residing in the member’s home and functioning as live-in help (eg, in an au-pair role)
* Peer-mediated groups or interventions
* Multiple family group therapy
* Training or classes for groups of parents of different patients
* Hippotherapy/equestrian therapy
* Pet therapy
* Auditory Integration Therapy
* Sensory Integration Therapy
* Visual Field Analysi

CPT 95940, 95941, g0453 - intraoperative neuophysiology moniotoring

Coding  Medically Necessary Code Description CPT

95940 Continuous intraoperative neurophysiology monitoring in the operating room, one on one monitoring requiring personal attendance, each 15 minutes (List separately in addition to code for primary procedure)

95941 Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating room, per hour (List separately in addition to code for primary procedure)


G0453 Continuous intraoperative neurophysiology monitoring, from outside the operatingroom (remote or nearby), per patient, (attention directed exclusively to one patient) each 15 minutes (list in addition to primary procedure)



Introduction

Tests can be done on specific nerves during complex brain, spine, and neck surgeries to help make sure the nerves are not being harmed. This is known as intraoperative neurophysiologic monitoring (IONM). There are a number of ways to perform this monitoring. It often involves the use of sophisticated medical devices to assess the muscle or electrical response when a nerve is stimulated. The goal is to provide the surgeon with immediate feedback about whether a nerve is at risk of being injured. The surgeon can make a correction right away to avoid permanent damage. This type of monitoring is well proven in specific types of surgeries. Some surgeons are using IONM during surgery for nerves located outside of the brain and spinal cord (the peripheral nerves). There is not enough medical evidence to show whether IONM leads to better health results when used for the peripheral nerves. For this reason, IONM is considered not medically necessary for peripheral nerve surgery.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Intraoperative Monitoring

Medical Necessity


* Somatosensory-evoked potentials
* Motor-evoked potentials using transcranial electrical stimulation
* Brainstem auditoryevoked potentials
* Electromyography (EMG)of cranial nerves
* Electroencephalography
* Electrocorticography

The types of Intraoperative neurophysiologic monitoring, listed on the left, may be considered medically necessary when there is significant risk of nerve or spinal cord injury during the following spinal, intracranial, vascular or recurrent laryngeal nerve surgical procedures: (this list may not be all inclusive)

* Aortic, thoracic, and abdominal aneurysm repair
* Aortic cross-clamping
* Arteriovenous malformation repair of the spinal cord
* Brachial plexus surgery
* Cerebral vascular surgery (eg, carotid endarterectomy, cerebral aneurysm)
* Clipping of intracranial aneurysms
* Cortical localization
* Interventional neuroradiology
* Pelvic fracture surgery
* Release of a tethered cord
* Repair of coarctation of the aorta
* Resection of fourth ventricular cyst
* Resection of intracranial vascular lesions
* Resection of spinal cord tumor, cyst, or vascular lesion
* Scoliosis correction with instrumentation
* Surgical stabilization of spine fractures
* Stereotactic surgery of the brain or brain stem, thalamus, or cerebral cortex
* Thalamus tumor resection or thalamotomy
* Thyroid surgery
* Anterior cervical spinal fusions
* Thoracic spine surgery

Intraoperative neurophysiologic monitoring for ANY other indication, including during lumbar surgery below L1/L2 is considered not medically necessary. (see Related Information)
* EMG The types of intraoperative neurophysiologic monitoring,


Intraoperative Monitoring Medical Necessity

* Nerve conduction velocity monitoring listed on the left during surgery on the peripheral nerves are considered not medically necessary. Intraoperative Monitoring Investigational
* Somatosensory-evoked potentials
* Motor-evoked potentials using transcranial electrical stimulation
* Brainstem auditoryevoked potentials
* Electromyography (EMG) of cranial nerves
* Electroencephalography
* Electrocorticography

The types of intraoperative neurophysiologic monitoring, listed on the left during the following surgical procedure is considered investigational:

* Esophageal surgeriesMotor-evoked potentials using transcranial magnetic stimulation

Due to the lack of monitors approved by the U.S. Food and Drug Administration, intraoperative monitoring of motorevoked potentials using transcranial magnetic stimulation is considered investigational.


Related Information

These policy statements refer only to use of these techniques as part of intraoperative monitoring. Other clinical applications of these techniques, such as visual-evoked potentials and

EMG, are not considered in this policy. Intraoperative neurophysiological monitoring is indicated in select spine surgeries when there is risk for additional spinal cord injury. Intraoperative monitoring has not been shown to be of clinical benefit for routine lumbar or cervical nerve root decompression (AANEM 2014), or during routine lumbar or cervical laminectomy or fusion (AANEM, 1999a) in the absence of myelopathy or other complicating conditions, which could increase the potential risk of damage to the nerve root or spinal cord, Resnick et al (2005) in published guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine reported that based on the medical evidence of the literature reviewed there did not appear to be support for the hypothesis that any form of intraoperative monitoring improves patient outcomes following lumbar decompression or fusion procedures for degenerative spinal disease. The authors concluded in a 2014 update there was no evidence that intraoperative monitoring can prevent injury to the nerve roots.

Intraoperative neurophysiologic monitoring including somatosensory-evoked potentials and motor-evoked potentials using transcranial electrical stimulation, brainstem auditory-evoked potentials, electromyography of cranial nerves, electroencephalography, and electrocorticography has broad acceptance, particularly for spine surgery and open abdominal aorta aneurysm repairs. Additionally, this policy addresses monitoring of the recurrent laryngealnerve during neck surgeries and monitoring of peripheral nerves.


Intra-operative monitoring is considered reimbursable as a separate service only when a licensed physician, other than the operating surgeon, performs the monitoring while in attendance in the operating room or present by means of a real-time remote mechanism and is immediately available to interpret the recording and advise the surgeon throughout the procedure.

Intra-operative monitoring consists of a physician monitoring not more than three cases simultaneously. Constant communication between surgeon, neurophysiologist, and anesthetist are required for safe and effective intraoperative neurophysiologic monitoring.

Evidence Review

Description


Intraoperative neurophysiologic monitoring (IONM) describes a variety of procedures used to monitor the integrity of neural pathways during high-risk neurosurgical, orthopedic, and vascular surgeries. It involves the detection of electrical signals produced by the nervous system in response to sensory or electrical stimuli to provide information about the functional integrity of neuronal structures. This policy does not address established neurophysiologic monitoring (ie, somatosensory-evoked potentials, motor-evoked potentials using transcranial electrical stimulation, brainstem auditory-evoked potentials, electromyography of cranial nerves,  electroencephalography, electrocorticography), during spinal, intracranial, or vascular procedures.

Background

Intraoperative Neurophysiologic Monitoring


The principal goal of intraoperative neurophysiologic monitoring (IONM) is identification of nervous system impairment on the assumption that prompt intervention will prevent permanent deficits. Correctable factors at surgery include circulatory disturbance, excess compression from retraction, bony structures, hematomas, or mechanical stretching. The technology is continuously evolving with refinements in equipment and analytic techniques, including recording, with several patients monitored under the supervision of a physician who is outside the operating room.

The different methodologies of monitoring are described next.


Sensory-Evoked Potentials

Sensory-evoked potential (SEP) describes the responses of the sensory pathways to sensory or electrical stimuli. Intraoperative monitoring of SEPs is used to assess the functional integrity of central nervous system (CNS) pathways during surgeries that put the spinal cord or brain at risk for significant ischemia or traumatic injury. The basic principles of SEP monitoring involve identification of a neurologic region at risk, selection and stimulation of a nerve that carries a signal through the at-risk region, and recording and interpretation of the signal at certain standardized points along the pathway. Monitoring of SEPs is commonly used during the following procedures: carotid endarterectomy, brain surgery involving vasculature, surgery with distraction compression or ischemia of the spinal cord and brainstem, and acoustic neuroma surgery. SEPs can be categorized by type of simulation used, as follow.

Somatosensory-Evoked Potentials

Somatosensory-evoked potentials (SSEPs) are cortical responses elicited by peripheral nerve stimulations. Peripheral nerves, such as the median, ulnar, or tibial nerves, are typically stimulated, but, in some situations, the spinal cord may be stimulated directly. Recording is done either cortically or at the level of the spinal cord above the surgical procedure. Intraoperative monitoring of SSEPs is most commonly used during orthopedic or neurologic surgery to prompt intervention to reduce surgically induced morbidity and/or to monitor the level of anesthesia. One of the most common indications for SSEP monitoring is in patients undergoing corrective surgery for scoliosis. In this setting, SSEP monitors the status of the posterior column pathways and thus does not reflect ischemia in the anterior (motor) pathways. Several different techniques are commonly used, including stimulation of a relevant peripheral nerve with monitoring from the scalp, from interspinous ligament needle electrodes, or from catheter electrodes in the epidural space


Brainstem Auditory-Evoked Potentials

Brainstem auditory-evoked potentials (BAEPs) are generated in response to auditory clicks and can define the functional status of the auditory nerve. Surgical resection of a cerebellopontine angle tumor, such as an acoustic neuroma, places the auditory nerves at risk, and BAEPs have been extensively used to monitor auditory function during these procedures.

Visual-Evoked Potentials

Visual-evoked potentials (VEPs) with light flashes are used to track visual signals from the retina to the occipital cortex. VEP monitoring has been used for surgery on lesions near the optic chiasm. However, VEPs are very difficult to interpret due to their sensitivity to anesthesia, temperature, and blood pressure.

Motor-Evoked Potentials

Motor-evoked potentials (MEPs) are recorded from muscles following direct or transcranial electrical stimulation of motor cortex or pulsed magnetic stimulation provided using a coil placed over the head. Peripheral motor responses (muscle activity) are recorded by electrodes placed on the skin at prescribed points along the motor pathways. MEPs, especially when induced by magnetic stimulation, can be affected by anesthesia. The Digitimer electrical cortical stimulator received U.S. Food and Drug Administration (FDA) premarket approval in 2002. Devices for transcranial magnetic stimulation have not been approved by the FDA for this use. Multimodal IONM, in which more than 1 technique is used, most commonly with SSEPs and MEPs, has also been described.

Electromyogram Monitoring and Nerve Conduction Velocity Measurements

Electromyography (EMG) monitoring and nerve conduction velocity measurements can be  performed in the operating room and may be used to assess the status of the cranial or peripheral nerves (eg, to identify the extent of nerve damage before nerve grafting or during resection of tumors). For procedures with a risk of vocal cord paralysis due to damage to the recurrent laryngeal nerve (ie, during carotid artery, thyroid, parathyroid, goiter, or anterior cervical spine procedures), monitoring of the vocal cords or vocal cord muscles has been performed. These techniques may also be used during procedures proximal to the nerve roots and peripheral nerves to assess the presence of excessive traction or other impairment. Surgery in the region of cranial nerves can be monitored by electrically stimulating the proximal (brain) end of the nerve and recording via EMG activity in the facial or neck muscles. Thus, monitoring is done in the direction opposite that of SEPs, but the purpose is similar—to verify that the neural pathway is intact. 

Electroencephalogram MonitoringSpontaneous electroencephalography (EEG) monitoring can also be used during surgery and can be subdivided as follows:

* EEG monitoring has been widely used to monitor cerebral ischemia secondary to carotid cross-clamping during a carotid endarterectomy. EEG monitoring may identify those patients who would benefit from the use of a vascular shunt during the procedure to restore adequate cerebral perfusion. Conversely, shunts, which have an associated risk of iatrogenic complications, may be avoided in those patients with a normal EEG. Carotid endarterectomy may be done with the patient under local anesthesia so that monitoring of cortical function can be directly assessed.

* Electrocorticography (ECoG) is the recording of the EEG activity directly from a surgically exposed cerebral cortex. ECoG is typically used to define the sensory cortex and map the critical limits of a surgical resection. ECoG recordings have been most frequently used to identify epileptogenic regions for resection. In these applications, ECoG does not constitute monitoring, per se.

Intraoperative neurophysiologic monitoring, including SSEPs and MEPs using transcranial electrical stimulation, BAEPs, EMG of cranial nerves, EEG, and ECoG, has broad acceptance, particularly for spine surgery and open abdominal aorta aneurysm repairs. These indications have long been considered standard of care, as evidenced by numerous society guidelines, including those from the American Academy of Neurology, American Clinical Neurophysiology Society, American Association of Neurological Surgeons, Congress of Neurologic Surgeons, and American Association of Neuromuscular & Electrodiagnostic Medicine.1-7 Additionally, this policy addresses monitoring of the recurrent laryngeal nerve during neck and esophageal surgeries and monitoring of peripheral nerves.

CPT 0340T, 19105, 20983, 32994, 50250, 50542, 50593 - Cryosurgical ablation

Coding Code Description CPT

0340T Ablation, pulmonary tumor(s), including pleura or chest wall when involved by tumor extension, percutaneous, cryoablation, unilateral, includes imaging guidance (code terminated 1/1/18, replaced by 32994)

19105 Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance, each fibroadenoma

20983 Ablation therapy for reduction or eradication of 1 or more bone tumors (eg, metastasis) including adjacent soft tissue when involved by tumor extension, percutaneous, including imaging guidance when performed; cryoablation

32994 Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; cryoablation (new code effective 1/1/18)

50250
Ablation, open, one or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound guidance and monitoring, if performed

50542 Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed

50593 Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy





Introduction

Cryosurgical ablation uses extreme cold to destroy certain types of tumors. A probe is inserted into the tumor and an extremely cold liquid is circulated through the probe. An icy ball forms around the probe to freeze part or all of the tumor. The probe can be positioned in such a way as to maximize harm to the tumor while sparing nearby health tissue. The frozen area thaws, allowing the body to absorb the treated tissue. The policy discusses when this technique is considered medically necessary for specific breast and kidney tumors. It’s also been tried for other kinds of tumors. Because larger and longer medical studies are needed, this technique is considered investigational (unproven) for other types of tumors.

This policy informs them about when a service may be covered. Service Medical Necessity Cryosurgical ablation of benign breast fibroadenomas Cryosurgical ablation of benign breast fibroadenomas may be considered medically necessary when ALL of the following criteria are met:

* The lesion must be sonographically visible AND
* The diagnosis of fibroadenoma is confirmed histologically AND
* The lesion(s) is less than 3 cm in largest diameter AND
* There are none of the following contraindications in existence:
o Large core biopsy diagnosis suggestive of cystosarcoma phyllodes tumor or other malignancy
o Poor visualization of lesion by ultrasound
o Large core biopsy diagnosis of fibroadenoma where diagnosis is thought to be non-concordant with findings on imaging or physical examination Cryosurgical ablation, localized renal cell carcinoma

Cryosurgical ablation may be considered medically necessary  to treat localized renal cell carcinoma that is no more than 4 cm in size when either of the following criteria is met:
* Preservation of kidney function is necessary (ie, the patient has one kidney or renal insufficiency defined by a glomerular filtration rate [GFR] of less than 60 mL/min per m2) and standard surgical approach (ie, resection of renal tissue) is likely to substantially worsen kidney function OR
* Patient is not considered a surgical candidate Lung cancer Cryosurgical ablation may be considered medically necessary to treat lung cancer when either of the following criteria is met:
* The patient has early-stage non-small cell lung cancer and is a poor surgical candidate OR
* The patient requires palliation for a central airway obstructing lesion.


Service Investigational Cryosurgical ablation,  malignant tumors
Cryosurgical ablation is considered investigational to treat individuals with ANY of the following:
* Bone cancer
* Lung cancer (other than defined above)
* Malignant tumors of the breast
* Other solid tumors or metastases outside the liver and prostate
* Pancreatic cancers
* Renal cell carcinomas in patients who are surgical candidates

Documentation Requirements

The patient’s medical records submitted for review for all conditions should document that medical necessity criteria are met. The record should include the following:
* For cryosurgical ablation of benign breast fibroadenomas, clinical documentation that includes:
o Lesion that is visible on an ultrasound
o Histological result confirming the diagnosis of fibroadenoma
o Size of the lesion
o And none of the following contraindications:
* Large core biopsy diagnosis that is suggestive of cystosarcoma phyllodes tumor or other malignancy
* Poor visualization of lesion by ultrasound
* Large core biopsy diagnosis of fibroadenoma where diagnosis is thought to be inconsistent with findings on imaging or physical examination
* For cryosurgical ablation of localized renal cell carcinoma, documentation of:
o The need to preserve the kidney because:
* Patient has one kidney OR

* Patient has renal insufficiency as defined by a glomerular filtration rate (GFR) of less than or equal to 60 mL/min/m, and standard surgical approach (ie, resection of renal tissue) is likely to substantially worsen kidney function OR
o Patient is considered not a surgical candidate
* For lung cancer, documentation of:
o Patient has early-stage non-small cell lung cancer and is a poor surgical candidate OR

Documentation Requirements

o The patient requires palliation for a central airway obstructing lesion


Evidence Review Description


Cryosurgical ablation (hereafter referred to as cryosurgery or cryoablation) involves freezing of target tissues; this is most often performed by inserting a coolant-carrying probe into the tumor. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.

Background

Breast Tumors


Early-stage primary breast tumors are treated surgically. The selection of lumpectomy, modified radical mastectomy, or another approach is balanced against the patient’s desire for breast conservation, the need for tumor-free margins in resected tissue, and the patient’s age, hormone receptor status, and other factors. Adjuvant radiation therapy decreases local recurrences, particularly for those who select lumpectomy. Adjuvant hormonal therapy and/or chemotherapy are added, depending on presence and number of involved nodes, hormone receptor status, and other factors. Treatment of metastatic disease includes surgery to remove the primary lesion and combination chemotherapy. Fibroadenomas are common, benign tumors of the breast that can either present as a palpable mass or a mammographic abnormality. These benign tumors have been frequently surgically excised to rule out a malignancy.

Lung Tumors

Early-stage lung tumors are typically treated surgically. Patients with early-stage lung cancer who are not surgical candidates may be candidates for radiotherapy with curative intent. Cryoablation is being investigated in patients who are medically inoperable, with small primary  lung cancers or lung metastases. Patients with more advanced local disease or metastaticdisease may undergo chemotherapy with radiation following resection. Treatment is rarely curative:rather, it seeks to retard tumor growth or palliate symptoms.


Pancreatic Cancer

Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults, and it is largely considered incurable. Surgical resection of tumors contained entirely within the pancreas is currently the only potentially curative treatment. However, the nature of the cancer is such that few tumors are found at such an early and potentially curable stage. Patients with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. Treatment focuses on slowing tumor growth and palliation of symptoms.

Renal Cell Carcinoma (RCC)

Localized renal cell carcinoma is treated with radical nephrectomy or nephron-sparing surgery. Prognosis drops precipitously if the tumor extends outside the kidney because chemotherapy is relatively ineffective against metastatic renal cell carcinoma.

Cryosurgical Treatment

Cryosurgical treatment of various tumors including malignant and benign breast disease, lung cancer, pancreatic cancer, and renal cell carcinoma has been reported in the literature. The hypothesized advantages of cryosurgery include improved local control and benefits common to any minimally invasive procedure (eg, preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization).

Summary of Evidence

For individuals who have solid tumors (located in areas of the breast, lung, pancreas, kidney, or bone) who receive cryosurgical ablation, the evidence includes nonrandomized comparative studies, case series, and systematic reviews of these nonrandomized studies. Relevant outcomes are overall survival, disease-specific survival, quality of life, and treatment-related morbidity.

There is a lack of randomized controlled trials and high-quality comparative studies to determine the efficacy and comparative effectiveness of cryoablation. The largest amount of evidence assesses renal cell carcinoma in select patients (ie, those with small tumors who are not surgical candidates, or those who have baseline renal insufficiency of such severity that standard


surgical procedures would impair their kidney function). Cryoablation results in short-term tumor control and less morbidity than surgical resection, but long-term outcomes may be inferior to surgery. For other indications, there is less evidence, with single-arm series reporting high rates of local control. Due to the lack of prospective controlled trials, it is difficult to conclude that cryoablation improves outcomes for any indication better than alternative treatments. The evidence is insufficient to determine the effects of the technology on health outcomes. However, based on clinical input, cryosurgical ablation of benign breast fibroadenomas is considered medically necessary when criteria are met.


CPT code 81334, 81432 - 81438, 0013U - Hereditary Breast cancer


Code Description CPT
 
0013U Oncology (solid organ neoplasia), gene rearrangement  detection by whole genome  next - generation sequencing, DNA, fresh or frozen tissue or cells, report of specific  gene rearrangement(s)  (MatePair Targeted Rearrangements, Oncology, Mayo Clinic)

0014U Hematology (hematolymphoid neoplasia), gene rearrangement  detection by whole  genome next - generation sequencing, DNA, whole blood or bone marrow, report of  specific gene rearrangement(s) ( MatePair Targeted Rearrangements, Hematologic,  Mayo Clinic)

0017U Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of  exons 12 - 14 and sequence analysis, blood or bone marrow, report of JAK2 mutation  not detected or detected ( JAK2 Mutation University of Iowa, Department of Pathology)

81334 RUNX1 (runt related transcription factor 1) (eg, acute myeloid leukemia, familial  platelet disorder with associated myeloid malignancy),gene   analysis, targeted sequence analysis (eg, exons 3 - 8) (new code effective 1/1/18)

81432 Hereditary breast cancer - related disorders (  eg , hereditary breast cancer, hereditary  ovarian cancer, hereditary endometrial cancer); genomic sequence analysis panel, must include sequencing of at least 14 genes, including ATM, BRCA1, BRCA2, BRIP1, CDH1,  MLH1, MSH2, MSH6, NBN, PALB2, PTEN, RAD51C, STK11, and TP53

81433 Hereditary breast  cancer - related disorders ( eg , hereditary breast cancer, hereditary  ovarian cancer, hereditary endometrial cancer);  duplication/deletion analysis panel,  must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11

81433 Hereditary breast  cancer - related disorders ( eg , hereditary breast cancer, hereditary  ovarian cancer, hereditary endometrial cancer); duplication/deletion analysis panel, must include analyses for BRCA1, BRCA2, MLH1, MSH2, and STK11

81434 Hereditary retinal disorders (eg, retinitis pigmentosa, Leber congenital amaurosis, cone-rod dystrophy), genomic sequence analysis panel, must include sequencing of atleast 15 genes, including ABCA4, CNGA1, CRB1, EYS, PDE6A, PDE6B, PRPF31, PRPH2,  RDH12, RHO, RP1, RP 2, RPE65, RPGR, and USH2 A

81435 Hereditary colon cancer syndromes (eg, Lynch syndrome, familial adenomatosis  polyposis); genomic sequence analysis panel, must include analysis of at least 7 genes, including APC, CHEK2, MLH1, MSH2, MSH6, MUTYH, and PMS2

81437 Hereditary  neuroendocrine tumor disorders (eg , medullary thyroid carcinoma,  parathyroid carcinoma, malignant pheochromocytoma or paraganglioma); genomic  sequence analysis panel, must include sequencing of at least 6 genes, including MAX,  SDHB, SDHC, SDHD, TMEM127, and VHL

81438 Hereditary neuroendocrine tumor disorders ( eg , medullary thyroid carcinoma,  parathyroid carcinoma, malignant pheochromocytoma or paraganglioma);
duplication/deletion analysis panel, must include analyses for SDHB, SDHC, SDHD, and  VHL

81455 Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm,  DNA and RNA analysis when performed, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MLL, NPM1, NRAS, MET, NOTCH1, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed

81479 Unlisted molecular pathology procedure


Introduction

A genetic panel is a test that measures many genes at one time. Next - generation sequencing  (NGS) is specific technology that conducts the test very  quickly and can look at many genes at once. NGS panels are made to find changes in genes (variants ) that might show more risk to  certain cancers, including inherited form s of cancer. NGS panels report  a huge volume of data.  However, it is not known how to use the data to make medical decisions.  Often a lot of unusable  data is reported. Published medical studies  have not shown that using the information from  NGS panels improve a person’s medical care. Genetic panels that use NGS are considered  investigational and unproven. The health plan does not pay for investigational services.

Note:
The Introduction section is for your general knowledge and is not to be  taken as policy coverage criteria . The  rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for  providers . A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider  also can be a place where medical care is given, like a hospital, clinic, or lab. This policy  informs them about when a  service may be covered.

Coding


Note : CPT codes, descriptions and materials are copyrighted by the  American Medical Association (AMA). HCPCS  codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited  disorders and who wish to undergo genetic testing. Interpreting  the results of genetic tests and understanding risk factors can be very difficult  for some patients; genetic counseling helps individuals understand
the impact of  genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce  inappropriate testing . Further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods


Commercially available cancer susceptibility gene panels can test for multiple variants associated  with a specific type of cancer or can include variants associated with a wide variety of cancers. While some patients may have a personal and/or family history of cancer that suggests the  cancer is syndrome -related, numerous genetic variants are associated with inherited cancer  syndromes. It has been proposed that variant testing using next - generation sequencing technology to analyze multiple genes at one time (panel testing) can optimize genetic testing in  these patients compared with sequencing single genes.

Genetic Testing for Cancer Susceptibility

Genetic testing for cancer susceptibility may be approached by a focused method that involves testing for well-characterized variants based on a clinical suspicion of which gene(s) may be the cause of the familial cancer. Panel testing involves testing for multiple variants in multiple genes at one time.
Several companies, including Ambry Genetics (Aliso Viejo, CA) and GeneDx (Gaithersburg, MD), offer genetic testing panels that use next-generation sequencing (NGS) methods for hereditary cancers. NGS refers to one of several methods that use massively parallel platforms to allow the sequencing of large stretches of DNA. Panel testing is potentially associated with greater efficiencies in the evaluation of genetic diseases; however, it may provide information on genetic variants of uncertain clinical significance or which would not lead to changes in patient management. Currently available panels do not include all genes associated with hereditary cancer syndromes. Also, these panels do not test for variants (ie, single-nucleotide variants [SNVs]), which may be associated with a low, but increased cancer risk.


CPT 81404, 81420, 81422, 00009M - Moleular pathology, Melanoma, Fetal aneupolidy

Code Description
CPT 81404 Molecular pathology procedure, Level 5 (eg, analysis of 2 - 5 exons by DNA sequence  analysis, mutation scanning or  duplication/deletion variants of 6 -10 exons, or characterization of a dynamic mutation disorder/triplet repeat by Southern blot analysis)

0009M Fetal aneuploidy (trisomy 21 and 18) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy

81420 Fetal chromosomal aneuploidy (eg, trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18 and 21

81422 Fetal chromosomal microdeletion(s) genomic sequence analysis (eg, DiGeorge syndrome, Cri-du-chat syndrome), circulating cell-free fetal DNA in maternal blood

81479 Unlisted molecular pathology procedure

81507 Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy

81599 Unlisted chemistry procedure

84999 Unlisted chemistry procedure

Introduction

Melanoma is one type of skin cancer. It begins in the melanocyte cells of the skin. These cells produce a pigment(melanin) that gives the skin its color, all the way from pink to dark. Damage to the DNA in melanocytes can cause the cells to grow out of control, leading to melanoma. It’s believed the main cause of melanoma is too much exposure to ultraviolet light, such as getting bad sunburns or using tanning lamps. Another risk factor is family history.If one person has melanoma then there’s a greater chance that the parent, child, brother, or sister could also develop melanoma.For those at high risk of getting melanoma , medical experts say the best ways to reduce the risk are to limit sun exposure, use sunscreen, and watch for unusual moles or other unusually colored areas of the skin. Genetic tests have been created to look for genetic changes related to melanoma. But results from these genetic tests wouldn’t change  recommendations for high risk people. Medical studies don’t show how genetic testing will lead to better health results.  Genetic testing for melanoma is considered unproven .

Note:
The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and  concepts familiar to medical professionals. It is intended for providers.A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic,or lab.This policy informs them about when a service may be covered.



Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the Human Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders

Genetic Counseling


Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Benefit Application
Genetic testing for genes associated with cutaneous malignant melanoma will likely be performed at specialty laboratories.

Description

Cutaneous melanoma is the third most common type of skin cancer, but the most lethal. Some cases of cutaneous malignant melanoma are familial. Potential genetic markers for this disease are being evaluated in affected individuals with a family history of disease and in unaffected individuals in a high -risk family

Cutaneous Malignant Melanoma

A genetic predisposition to Cutaneous Malignant Melanoma (CMM)is suspected in these specific clinical situations:
*Melanoma has been diagnosed in multiple family members

*Multiple primary melanomas are identified in a single patient

*Melanomas began at an early age

A positive family history of melanoma is the most significant risk factor. It is estimated that approximately 10% of patients with melanoma have a first -or second -degree relative with melanoma. Although some of the familial risk may be related to shared environmental factors, 3 main genes involved in CMM susceptibility have been identified. Cyclin-dependent kinase inhibitor 2A (CDKN2A), located on chromosome 9p21,encodes proteins that act as tumor suppressors. Variantsat this site can alter the tumor suppressor function. The second gene, cyclin-dependent kinase 4 (CDK4), is an oncogene located on chromosome 12q13 and has been identified in about 6 families worldwide. A third gene, not fully characterized, maps to chromosome 1p22. The incidence of CDKN2A variants in the general population is very low. For example, it is estimated that in Queensland, Australia, an area with a high incidence of melanoma, only 0.2% of all patients with melanoma will harbor a CDKN2A variant. Variants are also infrequent in those with an early age of onset or those with multiple primary melanomas.However, the incidence of CDKN2A variants increases with a positive family history; CDKN2A variants will be found in 5% of families with first -degree relatives, rising to 20% to 40% in kindreds with 3 or more affected first-degree relatives.Variant detection rates in the CDKN2A gene are generally estimated as 20% to 25% in hereditary CMM but can vary between 2% and 50%, depending on the family history and population studied. Validated clinical risk prediction tools to assess the probability that an affected individual carries a germline CDKN2A variant are available.


Familial CMM has been described in families in which either 2 first -degree relatives are diagnosed with melanoma or a family with 3 melanoma patients, irrespective of the degree of relationship.Others have defined familial CMM as having at least 3 (first-, second-, or third-degree) affected members or 2 affected family members in which at least one was diagnosed before age 50 years, or pancreatic cancer occurred in a first-or second-degree relative or 1
member had multiple primary melanomas.Other malignancies associated with familial CMM, specifically those associated with CDKN2A variants, have been escribed. The most pronounced associated malignancy is pancreatic cancer. Other associated malignancies include other gastrointestinal malignancies, breast cancer, brain cancer, lymphoproliferative malignancies, and lung cancer. It is also important to recognize that other cancer susceptibility genes may be
involved in these families. In particular, germline BRCA2 gene variants have been described in families with melanoma and breast cancer, gastrointestinal cancer, pancreatic cancer, or prostate cancer.

CMM can occur either with or without a family history of multiple dysplastic nevi. Families with both CMM and multiple dysplastic nevi have been referred to as having familial atypical multiple mole and melanoma syndrome (FAMMM). This syndrome is difficult to define because there is no agreement on a standard phenotype, and dysplastic nevi occur in up to 50% of the general population. Atypical or dysplastic nevi are associated with an increased risk for CMM. Initially, the phenotypes of atypical nevi and CMM were thought to cosegregate in FAMMM families, leading to the assumption that a single genetic factor was responsible. However, it was subsequently shown that in families with CDKN2A variants , there were family members with multiple atypical nevi who were non-carriers of the CDKN2A familial variant. Thus, the nevus phenotype cannot be used to distinguish carriers from non -carriers of CMM susceptibility in these families.

Some common allele(s) are associated with increased susceptibility to CMM but have low to moderate penetrance. One gene of moderate penetrance is the Melanocortin 1 receptor gene (MC1R). Variants in this gene are relatively common and have low penetrance for CMM. This gene is associated with fair complexion, freckles, and red hair, all risk factors for CMM. Variants in MC1R also modify the CMM risk in families with CDKN2A variants.
.

Summary of Evidence 


For individuals who have CMM and a family history of this disease who receive genetic testing for genes associated with familial CMM, the evidence includes genetic association studies correlating variants in certain genes and the risk of developing cutaneous melanoma. Relevant outcomes are overall survival, disease - specific survival, test accuracy, and test validity. Limitations with clinical validity include difficulties with variant interpretations, variable  penetrance of a given variant, and residual risk with a benign variant. Currently, management of melanoma patients does not change based on genetic variants identified in genes associated with familial CMM, therefore, clinical utility is lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are asymptomatic and in a family at high -risk of developing CMM who receive genetic testing for genes associated with familial CMM, the evidence includes genetic association studies correlating variants in certain genes and the risk of developing CMM. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and test validity. Limitations with clinical validity include difficulties with variant interpretations, variable

penetrance of a given variant, and residual risk with a benign variant. Currently, management of patients considered high risk for CMM focuses on the reduction of sun exposure, use of sunscreens, vigilant cutaneous surveillance of pigmented lesions, and prompt biopsy of suspicious lesions. It is unclear how genetic testing for variants associated with increased risk of CMM would alter these management recommendations; therefore, clinical utility is lacking. The evidence is insufficient to determine the effects of the technology on health outcomes.


Chromosomes are found in each cell and hold all of the genetic material —the DNA —of each person. Each cell usually contains 23 pairs of chromosomes, including the pair that determines the person’s sex. Having more or fewer chromosomes —known as aneuploidy —results in birth defects. Screening for aneuploidies is recommended during pregnancy. In the past, this screening was typically done by examining cells from the fetus. The cells were obtained either by taking a sample of the placenta or the amniotic fluid surrounding the baby. Newer tests that require only a blood sample from the mother can be used to screen for aneuploidies. This test looks at pieces of the fetus’s DNA that are naturally circulating in the mother’s blood. This policy describes when this type of blood test may be medically necessary. This blood test is investigational —unproven —when it’s used to look for missing pieces of chromosomes that are too small to be seen without a microscope. It’s also investigational when it’s used early in the pregnancy to look at the sex Chromosomes.  

Note:
The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers.A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab.This policy informs them about when a service may be covered.


Karyotyping would be necessary to exclude the possibility of a false -positive, nucleic acid sequencing–based test. Before testing, women should be counseled about the risk of a false-positive test.In Committee Opinion No. 640, the American College of Obstetricians and Gynecologists (2015) recommended that all patients receive information on the risks and benefits of various methods of prenatal screening and diagnostic testing for fetal aneuploidies, including the option of no testing.

Studies published to date on noninvasive prenatal screening for fetal aneuploidies have reported rare but occasional false-positives. False-positive findings have been found to be associated with factors including placental mosaicism, vanishing twins, and maternal malignancies. Diagnostic testing is necessary to confirm positive cell-free fetal DNA tests, and management decisions should not be based solely on the results of cell-free fetal DNA testing. The American College of Obstetricians and Gynecologists further recommended that patients with indeterminate or uninterpretable (ie, “no call”) cell -free fetal DNA test results be referred for genetic counseling and offered ultrasound evaluation and diagnostic testing because “no call” findings have been associated with an increased risk of aneuploidy

Cell -free fetal DNA screening does not assess risk of neural tube defects. Patients should continue to be offered ultrasound or maternal serum
*-fetoprotein screening.

Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics (see Table 1). The Society’s nomenclature is recommended by the Human Variome Project, the HUman Genome Organization, and by the Human Genome Variation Society itself.The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes.
Table 2 shows the recommended standard terminology—“pathogenic,” “likely pathogenic,” “uncertain significance,” “likely benign,” and “benign”—to describe variants identified that cause Mendelian disorders.

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at risk for inherited disorders and who wish to undergo genetic testing.Interpretating the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods

Description

National guidelines recommend that all pregnant women be offered screening for fetal chromosomal abnormalities, most of which are aneuploidies, an abnormal number of chromosomes. Trisomy syndromes are aneuploidies involving 3 copies of 1 chromosome. Trisomies 21 (T21), 18 (T18), and 13 (T13) are the most common forms of fetal aneuploidy. Fetuses with T18 and T13 generally do not survive to birth. There are numerous limitations to standard screening for these disorders using maternal serum and fetal ultrasound. Noninvasive prenatal screening (NIPS) analyzing cell-free fetal DNA in maternal serum is a potential complement or alternative to conventional serum screening. NIPS using cell-free fetal DNA has also been proposed to screen for microdeletions.

Fetal Aneuploidy

Fetal chromosomal abnormalities occur in approximately 1 in 160 live births. Most fetal chromosomal abnormalities are aneuploidies, defined as an abnormal number of chromosomes. The trisomy syndromes are aneuploidies involving 3 copies of 1 chromosome. The most important risk factor for trisomy syndromes is maternal age. The approximate risk of a trisomy 21 (T21; Down syndrome)*affected birth is 1 in 1100 at age 25 to 29. The risk of a fetus with T21 (at 16 weeks of gestation) is about 1 in 250 at age 35 and 1 in 75 at age 40.1T21 is the most common chromosomal aneuploidy and provides the impetus for current  maternal serum screening programs. Other trisomy syndromes include T18 (Edwards syndrome) and T13 (Patau syndrome), which are the next most common forms of fetal aneuploidy, although the percentage of cases surviving to birth is low and survival beyond birth is limited. Detection of T18 and T13 early in pregnancy can facilitate preparation for fetal loss or early intervention.

Fetal Aneuploidy Screening

Standard aneuploidy screening involves combinations of maternal serum markers and fetal ultrasound done at various stages of pregnancy. The detection rate for various combinations of noninvasive testing ranges from 60% to 96% when the false-positive rate is set at 5%. When tests indicate a high risk of a trisomy syndrome, direct karyotyping of fetal tissue obtained by amniocentesis or chorionic villous sampling (CVS) is required to confirm that T21 or another  trisomy is present. Both amniocentesis and CVS are invasive procedures and have procedure-associated risks of fetal injury, fetal loss, and infection.

A new screening strategy that reduces unnecessary amniocentesis and CVS procedures or increases detection of T21, T18, and T13 could improve outcomes. Confirmation of positive noninvasive screening tests with amniocentesis or CVS is recommended; with more accurate tests, fewer women would receive positive screening results.

Commercial, noninvasive, sequencing-based testing of maternal serum for fetal trisomy syndromes is now available. The testing technology involves detection of cell-free fetal DNA fragments present in the plasma of pregnant women. As early as 8 to 10 weeks of gestation, these fetal DNA fragments comprise 6% to 10% or more of the total cell -free DNA in a maternal plasma sample. The tests are unable to provide a result if the fetal fraction is too low, (ie, <4 .="" affected="" and="" at="" be="" br="" by="" can="" characteristics.="" crown-rump="" example="" fetal="" for="" found="" fraction="" higher="" increasing="" length.="" lower="" maternal="" nd="" the="" to="" was="" weights="" with="">
Cell-Free Fetal DNA Analysis Methods

Sequencing-based tests use 1 of 2 general approaches to analyzing cell-free DNA. The first category of tests uses quantitative or counting methods. The most widely used technique to date uses massively parallel sequencing (MPS; also known as next-generation sequencing). DNA fragments are amplified by polymerase chain reaction; during the sequencing process, the amplified fragments are spatially segregated and sequenced simultaneously in a massively parallel fashion. Sequenced fragments can be mapped to the reference human genome to obtain numbers of fragment counts per chromosome. The sequencing-derived percent of fragments from the chromosome of interest reflects the chromosomal representation of the maternal and fetal DNA fragments in the original maternal plasma sample. Another technique is direct DNA analysis, which analyzes specific cell-free DNA fragments across samples and requires approximately a tenth the number of cell-free DNA fragments as MPS. The digital analysis of selected regions (DANSR™) is an assay that uses direct DNA analysis.

The second general approach is single nucleotide variant-based methods. These use targeted amplification and analysis of approximately 20,000 single nucleotide variants on selected chromosomes (eg, 21, 18, 13) in a single reaction. A statistical algorithm is used to determine the number of each type of chromosome. At least some of the commercially available cell-free fetal DNA prenatal tests also test for other abnormalities including sex chromosome abnormalities and selected microdeletions.

Copy Number Variants and Clinical Disorders

Microdeletions (also known as submicroscopic deletions) are chromosomal deletions that are too small to be detected by microscopy or conventional cytogenetic methods. They can be as small as 1 and 3 megabases long. Along with microduplications, microdeletions are collectively known as copy number variants. Copy number variants can lead to disease when the change in copy number of a dose-sensitive gene or genes disrupts the ability of the gene(s) to function  and affects the amount of protein produced. A number of genomic disorders associated with microdeletion have been identified, which may be associated with  serious clinical features, such as cardiac anomalies, immune deficiency, palatal defects, and developmental delay as in DiGeorge syndrome. Some of the syndromes (eg, DiGeorge) have complete penetrance yet marked variability in clinical expressivity. A contributing factor is that the breakpoints of the  microdeletions may vary, and there may be a correlation between the number of haplo-insufficient genes and phenotypic severity.

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