CPT 22513, 22514, 22515- Percuaneous Vertebral augmentation

Coding

In 2015, the CPT codes combined the kyphoplasty procedure with all of the necessary imaging guidance; they are listed in the table below.

Code Description CPT

22513 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; thoracic

22514 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; lumbar

22515 Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device (eg, kyphoplasty), 1 vertebral body, unilateral or bilateral cannulation, inclusive of all imaging guidance; each additional thoracic or lumbar vertebral body


Introduction
Kyphoplasty is a type of surgery that stabilizes a vertebra (a bone of the spine) after a compression fracture. A compression fracture usually happens at the front side of the vertebra. The front collapses, leaving a vertebra that looks a bit like a wedge. The goal of kyphoplasty is to reduce pain and return the vertebra to its normal height. A hollow needle or similar instrument is inserted through the skin and into the damaged area of the bone. Either a balloon is inflated or a device is uncoiled to create a hollow space at the front of the bone, bringing it back to its normal height. If a balloon is used, it’s then removed. If a coil device is used, it remains. A type of bone cement is then injected into the hollow space. The cement hardens after a few minutes. This policy describes when this procedure may be considered medically necessary.

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 Percutaneous balloon kyphoplasty and Kiva®

Percutaneous balloon kyphoplasty and Kiva® may be considered medically necessary for the treatment of symptomatic osteoporotic vertebral compression fractures that have failed to respond to at least 6 weeks of conservative treatment (eg, analgesics, physical therapy, rest).

Percutaneous balloon kyphoplasty and Kiva® may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Service Investigational Percutaneous balloon kyphoplasty and Kiva®

Percutaneous balloon kyphoplasty and Kiva® are considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma. Percutaneous radiofrequency kyphoplasty or percutaneous mechanical vertebral augmentation using any other device is considered investigational.


Note: Based on currently available evidence, health outcomes for kyphoplasty, Kiva®, and

vertebroplasty appear to be equivalent, therefore, the “least costly alternative” provision of the medically necessary definition may apply.

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:

* Relevant history and physical supporting painful osteoporotic vertebral compression fractures that have failed to respond to at least 6 weeks of conservative treatment (eg, analgesics, physical therapy, rest) OR

* Severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies


Description

Percutaneous balloon kyphoplasty, radiofrequency kyphoplasty, and mechanical vertebral augmentation with Kiva are interventional techniques involving the fluoroscopically guided injection of polymethylmethacrylate (PMMA) into a cavity created in the vertebral body with a balloon or mechanical device. These techniques have been investigated as options to provide mechanical support and symptomatic relief in patients with osteoporotic vertebral compression fracture or in those with osteolytic lesions of the spine (eg, due to multiple myeloma or metastatic malignancies).

Background

Osteoporotic Vertebral Compression Fracture


Osteoporotic compression fractures are common. It is estimated that up to 50% of women and 25% of men will have a vertebral fracture at some point in their lives. However, only about onethird of vertebral fractures actually reach clinical diagnosis, and most symptomatic fractures will heal within a few weeks or 1 month. A minority of patients will exhibit chronic pain following an osteoporotic compression fracture that present challenges for medical management.

Treatment

Chronic symptoms do not tend to respond to the management strategies for acute pain such as bedrest, immobilization or bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments  secondary to kyphosis. This type of pain frequently is not improved with analgesics and may be better addressed through exercise.

Osteolytic Vertebral Body Fractures

Vertebral body fractures can also be pathologic, due to osteolytic lesions, most commonly from metastatic tumors. Metastatic malignant disease involving the spine generally involves the vertebral bodies, with pain being the most frequent complaint


Treatment

While radiotherapy and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed for days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain vertebral body strength, which may necessitate supportive bracing to minimize the risk of vertebral body collapse during healing.

Kyphoplasty

Balloon kyphoplasty is a variant of vertebroplasty and uses a specialized bone tamp with an inflatable balloon to expand a collapsed vertebral body as close as possible to its natural height before injection of polymethylmethacrylate (PMMA). Radiofrequency kyphoplasty (also known as radiofrequency targeted vertebral augmentation) is a modification of balloon kyphoplasty. In this procedure, a small-diameter articulating osteotome creates paths across the vertebra. An ultra-high viscosity cement is injected into the fractured vertebral body and radiofrequency is used to achieve the desired consistency of the cement. The ultra-high viscosity cement is designed to restore height and alignment to the fractured vertebra, along with stabilizing the fracture.

It has been proposed that kyphoplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other possible mechanisms of effect have been postulated, one of which is thermal damage to intraosseous nerve fibers, given that PMMA undergoes a heat-releasing (exothermic) reaction during its hardening process.

Vertebral Augmentation

Kiva® is another mechanical vertebral augmentation technique that uses an implant for structural support of the vertebral body to provide a reservoir for bone cement. The Kiva® VCF Treatment System consists of a shaped memory coil and an implant, which is filled with bone cement. The coil is inserted into the vertebral body over a removable guide wire. The coil reconfigures itself into a stack of loops within the vertebral body and can be customized by changing the number of loops of the coil. The implant, made from PEEK-OPTIMA® (a biocompatible polymer) is deployed over the coil. The coil is then retracted and PMMA is injected through the lumen of the implant. The PMMA cement flows through small slots in the center of the implant, which fixes the implant to the vertebral body and contains the PMMA in a cylindrical column. The proposed advantage of the Kiva system is a reduction in cement leakage.

Outcome Measures

For treatment of osteoporosis and malignancy with percutaneous kyphoplasty, the primary beneficial outcomes of interest are relief of pain and improvement in the ability to function. Kyphoplasty may also restore lost vertebral body height and reduce kyphotic deformity. Potential health outcomes related to kyphotic deformity include pulmonary or gastrointestinal compression and associated symptoms, and vertebral compression fractures may be associated with lower health-related quality of life.

Summary of Evidence


For individuals who have osteoporotic vertebral compression fractures who receive balloon kyphoplasty or mechanical vertebral augmentation (Kiva), the evidence includes randomized controlled trials (RCTs) and meta-analyses. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. A meta-analysis and moderately sized unblinded RCT have compared kyphoplasty with conservative care and found short-term benefits in pain and other outcomes. Other RCTs, summarized in a meta-analysis, have reported similar outcomes for kyphoplasty and vertebroplasty. Two randomized trials that compared mechanical vertebral augmentation (Kiva) with kyphoplasty have reported similar outcomes for both procedures. A major limitation of all these RCTs is the lack of a sham procedure. Due to the possible sham effect observed in the recent trials of vertebroplasty, the validity of the results from non-sham-controlled trials is unclear. Therefore, whether these improvements represent a true treatment effect is uncertain. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have osteolytic vertebral compression fractures who receive balloon kyphoplasty or mechanical vertebral augmentation (Kiva), the evidence includes RCTs, case series, and a systematic review of these studies. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. Two RCTs compared balloon kyphoplasty with conservative management and another has compared Kiva with balloon kyphoplasty. Results of these trials, along with case series, would suggest a reduction in pain, disability, and analgesic use in patients with cancer-related compression fractures. However, because the results of the comparative studies of vertebroplasty have suggested possible placebo or natural history effects, the evidence these studies provide is insufficient to warrant conclusions about the effect of kyphoplasty on health outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have osteoporotic or osteolytic vertebral compression fractures who receive radiofrequency kyphoplasty, the evidence includes a systematic review and an RCT. Relevant outcomes include symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related morbidity. The only RCT (N=80) identified showed similar results between radiofrequency kyphoplasty and balloon kyphoplasty. The systematic review suggested that radiofrequency kyphoplasty is superior to balloon kyphoplasty in pain relief, but the review itself was limited by the inclusion of a small number of studies as well as possible bias. Corroboration of these results in a larger number of patients is needed to determine with greater certainty whether radiofrequency kyphoplasty provides outcomes similar to balloon kyphoplasty. The evidence is insufficient to determine the effects of the technology on health outcomes.

CPT 81205, 81206, 81207, 81208 - Chronic mylogenous leukemia




Coding Code Description CPT
81205 BCKDHB (branched-chain keto acid dehydrogenase E1, beta polypeptide) (eg, Maple syrup urine disease) gene analysis, common variants (eg, R183P, G278S, E422X)

81206 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; major breakpoint, qualitative or quantitative

81207 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; minor breakpoint, qualitative or quantitative

81208 BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis; other breakpoint, qualitative or quantitative



Introduction

A companion diagnostic test is specific type of medical test. It determines whether a person would respond to a particular drug. Only certain drugs have a companion diagnostic test. These are drugs, such as chemotherapy treatments, that usually have serious side effects. Companion diagnostic tests help doctors weigh if a drug’s benefits could be greater than its risks or side effects. Companion diagnostic tests help people who would respond to treatment get the drugs they need while avoiding unnecessary treatment and side effects among those who wouldn’t.

This policy discusses when companion diagnostic tests may be considered medically necessary.

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.

Coverage Guidelines

The following coverage criteria apply to drugs with companion diagnostic tests, whenever there is not a specific medical policy covering the situation. If a drug-specific medical policy addresses the case circumstances, that policy will take precedence over this more general policy.

Medical Necessity


For drugs that have a specific companion diagnostic test, the test may be considered medically necessary when:

* The diagnostic test has been performed AND

* Test results predict that the drug will be of benefit to the patient for whom it is prescribed AND

* The drug is prescribed for a labeled indication in a patient that meets the FDA-approved criteria for prescribing it Such companion diagnostic tests may be considered medically necessary for any patient in whom use of the drug is contemplated and the test informs whether use of the drug is expected to yield benefit to that patient. Other uses of these tests are considered not medically necessary.

NOTE: Requests for approval of the drug should be accompanied by documentation of test results. In cases where the FDA has approved a drug with a specific branded companion test, determination of medical necessity may be based on that test, or any reasonable equivalent, whether specifically named in the label or not.



Related Information

Personalized Medicine


Personalized medicine is a general term that may be used to refer to any set of strategies used to select therapeutic approaches that are tailored to specific patients. Therapies may be identified by any clinically valid means, including demographic factors, genetic, phenotypic or biochemical markers, imaging techniques, etc.

Companion Diagnostics


Companion diagnostics are specific tests used to predict responsiveness of a patient to specific drugs or other treatments. In a more restrictive sense, the term is usually used to refer to genomic, proteomic or metabolomic testing. Genetic tests may identify a single nucleotide polymorphism (SNP) or a panel of SNPs that correlate strongly with positive response.

Evaluation of Companion Diagnostics


Evidence demonstrating the value of a companion diagnostics is categorized in three stages:

Analytic validity – How accurately and reliably the test measures the genotype or other marker of interest.

Clinical validity – How consistently and accurately the test detects or predicts the intermediate or final clinical outcomes of interest.

Clinical utility – How likely the test is to significantly improve patient outcomes.

Demonstration of clinical validity is normally expected when vetting a companion diagnostic; however, clinical utility requires longer term studies and will probably not be validated for months or years following product launch.

Benefit Application

This coverage is managed through the Pharmacy benefit.


Rationale
Development of new technologies such as whole genome assay studies (GWAS) and biobanking of clinical trial tissue samples have greatly increased the potential for identifying companion diagnostics. A previously identified marker may also be found to correlate with therapeutic outcomes, such as the Philadelphia chromosome and Bcr-Abl mutation, which have been found to have a high predictive value for response to imatinib and other targeted kinase inhibitors. The intent of this policy is broadly inclusive; covering any diagnostic methodology specified in the drug’s approved labeling, regardless of whether it is a specific proprietary test or a generic one.

The completion of the human genome sequencing project a decade ago launched a period of rapid growth in the field. The impact of modern high throughput sequencing and DNA microarray chips has dramatically increased the power of genetics research and the resulting pool of information. In the past six years, more than 1000 regions of the human genome have been associated with specific traits and diseases. In this decade, commercialized specific diagnostic test and drug pairs are beginning to emerge from the pipeline and receive final FDA approval. These represent the first of a flood of such products expected to follow.

In some cases, eg, imatinib and the Bcr-Abl mutation, the pairing will be unquestionable, and review for medical necessity may prove unnecessary. In others, potential off-label uses will develop rapidly and prescriber demand may precede the corresponding scientific evidence. For instance, ivacaftor, a recently approved novel therapy for cystic fibrosis patients, acts to improve function of CFTR chloride transport channels in patients with a G551D point mutation. This is only one of over 23 identified polymorphisms that may result in cystic fibrosis. Ivacaftor is currently under investigation for use in several other mutations, but results of these studies are not yet available; however, requests for these off-label uses are already beginning to be made. This example illustrates the need to manage off-label use. With the growing number of new diagnostic/drug pairs being approved, a more generalized approach to managing utilization is required.

As genetic science advances rapidly into this field, investigators are encountering new orders of magnitude of complexity. Despite the milestones achieved since 2001, we are still far from understanding the mechanisms behind most of the diseases being studied. Given the desperation of patients and physicians faced with incurable chronic diseases, experimentation beyond the limits of evidence-based medicine is bound to occur. This policy is designed to provide a simple administrative means of ensuring that clinical practice does not outpace research.

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.


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