CPT 20974, 20975, E0747 - Electrical Bone Growth stimulator


Code Description CPT

20974 Electrical stimulation to aid bone healing; noninvasive (non-operative)

20975 Electrical stimulation to aid bone healing; invasive (operative)

HCPCS

E0747 Osteogenesis stimulator, electrical, noninvasive, other than spinal applications

E0749 Osteogenesis stimulator, electrical, surgically implanted

Electrical Bone Growth Stimulation of the Appendicular Skeleton


Introduction

An electrical bone growth stimulator can be used to help a broken bone heal in certain situations. The stimulators send electrical pulses or current through tissues, toward the bone. Electrical bone growth stimulators appear to encourage the growth of bone cells. Electrical bone growth stimulators are either noninvasive, invasive (implantable), or semi-invasive (semiimplantable).
* Noninvasive stimulators deliver current through small patches (electrodes) or coils placed near the broken bone.
* Invasive electrical stimulation use devices that are implanted in the body.
* Semi-invasive stimulators use needle-like electrodes placed through the skin.

This policy discusses when noninvasive electrical bone growth stimulators may be approved.

Invasive and semi-invasive bone growth stimulators are considered unproven (investigational). More study is needed on these two types of stimulators to see if they are safe and effective.


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.


Policy Coverage Criteria Procedure Medical Necessity Noninvasive electrical bone growth stimulation

Noninvasive electrical bone growth stimulation may be considered medically necessary as treatment of fracture nonunions or congenital pseudoarthrosis in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities). The diagnosis of fracture nonunion must meet

ALL of the following criteria:

* At least 3 months have passed since the date of fracture AND
* Serial radiographs have confirmed that no progressive signs of healing have occurred AND
* The fracture gap is 1 cm or less AND
* The fracture can be adequately immobilized AND
* The patient is of an age likely to comply with nonweight bearing for fractures of the pelvis and lower extremities


Procedure Investigational Noninvasive electrical bone growth stimulation

Investigational applications of electrical bone growth stimulation include, but are not limited to:

* Delayed union
* Fresh fracture
* Stress fractures
* Immediate postsurgical treatment after appendicular skeletal surgery

Procedure Investigational

* Arthrodesis
* Failed arthrodesis

Implantable and semiinvasive electrical bone growth stimulators Implantable and semi-invasive electrical bone growth stimulators are considered investigational.

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 diagnoses of fracture nonunions or congenital pseudoarthrosis in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities)

In addition, for diagnosis of diagnosis of fracture nonunion, ALL of the following criteria must be met:
* The fracture happened at least 3 months ago
* Serial radiographs confirm that no progressive signs of healing have occurred
* The width of the break is less than 1 centimeter (about 1/3 of an inch)
* Patient is able to limit physical movements
* Patient is of an age likely to comply with staying nonweight bearing during treatment for fractures of the pelvis and lower extremities



Definition of Terms

Appendicular skeleton: The appendicular skeleton includes the bones of the shoulder girdle, the upper extremities, the pelvis, and the lower extremities.

Congenital pseudoarthrosis: Congenital pseudarthrosis of the tibia (CPT) is a rare condition that is usually seen shortly after birth and is rarely diagnosed after the age of two. It appears as a bowing of the tibial bone and could led to a fracture if not found before the child begins to walk. Children with CPT may have poor healing ability and attempts to unite the small bone fragments can cause damage to the tibia and/or ankle joint. Congenital pseudarthrosis of the tibia has been linked to Type 1 neurofibromatosis but the exact cause of CPT is unknown.2 Delayed union: Delayed union is defined as a decelerating healing process as determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the injury or the most recent intervention. In contrast, fracture nonunion (described below) serial radiographsshow no evidence of healing. When lumped together, delayed union and nonunion are sometimes referred to as “ununited fractures.”

Fracture nonunion: No consensus on the definition of fracture nonunions currently exists. One proposed definition is failure of progression of fracture healing for at least 3 consecutive months (and at least 6 months following the fracture) accompanied by clinical symptoms of delayed/nonunion such as pain, difficulty weight bearing (Bhandari et al, 2012). The original U.S. Food and Drug Administration (FDA) labeling of fracture nonunions defined them as fractures not showing progressive healing after at least 9 months from the original injury. The labeling states: “A nonunion is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for minimum of 3 months.” This timeframe is not based on physiologic principles but was included as part of the research design for FDA approval as a means of ensuring homogeneous populations of patients, many of whom were serving as their own controls. Others have contended that 9 months represents an arbitrary cutoff point that does not reflect

the complicated variables present in fractures (ie, degree of soft tissue damage, alignment of the bone fragments, vascularity, quality of the underlying bone stock). Some fractures may show no signs of healing, based on serial radiographs as early as 3 months, while a fracture nonunion may not be diagnosed in others until well after 9 months. The current policy of requiring a 3- month timeframe for lack of progression of healing is consistent with the definition of nonunion   as described in the clinical literature.Fresh fracture: A fracture is most commonly defined as “fresh” for 7 days after its occurrence. Most fresh closed fractures heal without complications with the use of standard fracture care (ie, closed reduction and cast immobilization).

Benefit Application State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration*approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity. Noninvasive electrical bone growth stimulation devices may be adjudicated according to the benefits for durable medical equipment.

Evidence Review Description

In the appendicular skeleton, electrical stimulation with either implantable electrodes or noninvasive surface stimulators has been investigated to facilitate the healing of fresh fractures, stress fractures, delayed union, nonunion, congenital pseudoarthroses, and arthrodesis.

Background

Delayed Fracture Healing


Most bone fractures heal spontaneously over a few months postinjury. Approximately 5% to 10% of all fractures have delayed healing, resulting in continued morbidity and increased utilization of health care services.


There is no standard definition of a fracture nonunion.2 The Food and Drug Administration (FDA) labeling for one of the electrical stimulators included in this review defined nonunion as follows:

"A nonunion is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for a minimum of 3 months." Others have contended that 9 months represents an arbitrary cutoff point that does not reflect the complicated variables present in fractures (ie, the degree of soft tissue damage, alignment of the bone fragments, vascularity, quality of the underlying bone stock). Other proposed definitions of nonunion involve 3 to 6 months from the original injury, or simply when serial radiographs fail to show any further healing. According to FDA labeling for a low-intensity pulsed ultrasound device, “a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.” Factors contributing to a nonunion include: which bone is fractured, fracture site, the degree of bone loss, time since injury, the extent of soft tissue injury, and patient factors (eg, smoking, diabetes, systemic disease).1

Delayed union is generally considered a failure to heal between 3 and 9 months postfracture, after which the fracture site would be considered a nonunion. Delayed union may also be defined as a decelerating bone healing process, as identified in serial radiographs. (In contrast, nonunion serial radiographs show no evidence of healing.) Together, delayed union and nonunion are sometimes referred to as "ununited fractures." To determine fracture healing status, it is important to include both radiographic and clinical criteria. Clinical criteria include the lack of ability to bear weight, fracture pain, and tenderness on palpation. Fractures at certain locations (eg, scaphoid, proximal fifth metatarsal) are at greater risk of delayed union due to a tenuous blood supply. Systemic factors — including immunosuppression, cancer, and tobacco use — may also predispose patients to fracture nonunion, along with certain medications (eg, nonsteroidal anti-inflammatory drugs, fluoroquinolones).

Treatment

Individuals with recognized delayed fracture unions might begin by reducing the risk factors for delayed unions or nonunions but may progress to surgical repair if it persists. Electrical and Electromagnetic Bone Growth Stimulators Different applications of electrical and electromagnetic fields have been used to promote healing of delayed and nonunion fractures: invasive, noninvasive, and semi-invasive.

* Invasive: Invasive stimulation involves the surgical implantation of a cathode at the fracture to produce direct-current electrical stimulation. Invasive devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation, and, although the current generator is removed in a second surgical procedure when stimulation is completed, the electrode may or may not be removed. Implantable electrodes provide constant stimulation at the nonunion or fracture site but carry increased risks associated with implantable leads.

* Noninvasive: Noninvasive electrical bone growth stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the fusion site and worn for 24-hours per day until healing occurs, or up to 9 months. In contrast, pulsed electromagnetic fields are delivered via treatment coils that are placed on the skin over the fracture and are worn for 6-hours to 8-hours per day for 3 to 6 months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field. This device involves a 30-minute treatment period each day for 9 months. Patient compliance may be an issue with externally worn devices.

* Semi-Invasive: Semi-invasive (semi-implantable) stimulators use percutaneous electrodes and an external power supply, obviating the need for a surgical procedure to remove the generator when treatment is finished.

CPT 76120, 76125, 76496, 76499 - Dynamic spinal visualization

Coding Code Description CPT

76120 Cineradiography/videoradiography, except where specifically included

76125 Cineradiography/videoradiography to complement routine examination (list separately in addition to code for primary procedure)

76496 Unlisted fluoroscopic procedure (eg, diagnostic, interventional)

76499 Unlisted diagnostic radiographic procedure



Introduction

Dynamic spinal visualization is a way to see how the spine moves as a person bends or twists.

It’s thought that looking at moving images could help a healthcare professional diagnose the cause of neck or back pain or other problems with the spine. There are several different ways to create moving images as the spine twists or turns. Most techniques use x-ray to create images on film, a video monitor, or computer screen. Several x-rays are taken, assembled in order, and then played to create a moving image. Other technologies use fluoroscopy and MRI. Because there are not enough medical studies to show how well dynamic spinal visualization works, it’s 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.


Policy Coverage Criteria


Service Investigational Dynamic spinal visualization (eg, The KineGraph VMA™)

The following dynamic spinal visualization techniques are considered investigational, including, but not limited to:
* Digital motion x-ray of the spine
* Cineradiography/videofluoroscopy
* Dynamic magnetic resonance imaging



Evidence Review Description

Dynamic spinal visualization is a general term addressing different imaging technologies that technologies have been proposed for the evaluation of spinal disorders including neck and back pain.

Background

Most spinal visualization methods use x-rays to create images either on film, video monitor, or computer screen. Digital motion x-ray involves the use of either film x-ray or computer-based xray “snapshots” taken in sequence as a patient moves. Film x-rays are digitized into a computer for manipulation, while computer-based x-rays are automatically created in a digital format.

Using a computer program, the digitized snapshots are then put in order and played on a video monitor, creating a moving image of the inside of the body. This moving image can then be reviewed by a physician, either alone or by using a computer, to evaluate several aspects of the body’s structure in order to determine the presence or absence of abnormalities. One use of this technology may be to examine intervertebral flexion and extension.

Videofluoroscopy and cineradiography are different names for the same procedure, which uses fluoroscopy to create real-time video images of internal structures of the body. Unlike standard x-rays, which take a single picture at one point in time, fluoroscopy provides motion pictures of the body. The results of these techniques can be displayed on a video monitor as the procedure is being conducted, as well as recorded, to allow computer analysis or evaluation at a later time.

Like digital motion x-ray, the results can be evaluated by a physician alone or with the assistance of computer analysis software.

Dynamic magnetic resonance imaging (MRI) is also being developed for imaging of the cervical spine. This technique uses an MRI-compatible stepless motorized positioning device (NeuroSwing, Fresenius/Siemens) and a real-time true fast imaging with steady-state precession sequence to provide passive kinematic imaging of the cervical spine. The quality of the images is lower than a typical MRI sequence, but is proposed to be adequate to observe changes in the alignment of vertebral bodies, the width of the spinal canal, and the spinal cord. Higher resolution imaging can be performed at the end positions of flexion and extension.

Summary of Evidence

For individuals who have back or neck pain who receive dynamic spinal visualization, the evidence includes comparative trials. Relevant outcomes are test accuracy, symptoms, and functional outcomes. Techniques include digital motion x-rays, cineradiography/ videofluoroscopy, or dynamic magnetic resonance imaging of the spine and neck. The available  studies compare spine kinetics in patients with neck or back pain to that in healthy controls. Noliterature was identified on the diagnostic accuracy of dynamic visualization in a relevant patient population. No evidence was identified on the effect of this technology on symptoms or functional outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.

According to Hayes, there is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management for the use of Vertebral Motion Analysis for assessing spinal instability. (Hayes 2017) Practice Guidelines and Position Statements No guidelines or statements were identified.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

Regulatory Status

In 2012, The KineGraph VMA™ (Vertebral Motion Analyzer, Ortho Kinematics) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The system includes a Motion Normalizer™ for patient positioning, standard fluoroscopic imaging, and automated image recognition software. Processing of scans by Ortho Kinematics is charged separately.

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

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