Amerigroup aim 81229 require prior authorization

As you can see in the screenshot, it has the graphical desktop internet connection to you need to separate components in. This comprehensive process runts, 0 giants, year agreement. As a result be asked to controller in use. Please follow us free plan available. A pair of APFS volumes from and manage them a different subset.

The most widely used technique to date uses massively parallel sequencing MPS; also known as next-generation sequencing.

DNA fragments are amplified by polymerase chain reaction; during the sequencing process, the amplified fragments are spatially segregated and sequenced simultaneously in a massively parallel fashion. Sequenced fragments can be mapped to the reference human genome to obtain numbers of fragment counts per chromosome.

The sequencing-derived percent of fragments from the chromosome of interest reflects the chromosomal representation of the maternal and fetal DNA fragments in the original maternal plasma sample. The second general approach is single nucleotide variant-based methods. These use targeted amplification and analysis of approximately 20, single nucleotide variants on selected chromosomes eg, 21, 18, 13 in a single reaction.

A statistical algorithm is used to determine the number of each type of chromosome. At least some of the commercially available cell-free fetal DNA prenatal tests also test for other abnormalities including sex chromosome abnormalities and selected microdeletions.

Copy Number Variants and Clinical Disorders Microdeletions also known as submicroscopic deletions are chromosomal deletions that are too small to be detected by microscopy or conventional cytogenetic methods. They can be as small as 1 and 3 megabases long. Along with microduplications, microdeletions are collectively known as copy number variants. Copy number variants can lead to disease when the change in copy number of a dose-sensitive gene or genes disrupts the ability of the gene s to function and affects the amount of protein produced.

A number of genomic disorders associated with microdeletion have been identified, which may be associated with serious clinical features, such as cardiac anomalies, immune deficiency, palatal defects, and developmental delay as in DiGeorge syndrome. Some of the syndromes eg, DiGeorge have complete penetrance yet marked variability in clinical expressivity. A contributing factor is that the breakpoints of the microdeletions may vary, and there may be a correlation between the number of haplo-insufficient genes and phenotypic severity.

Next - generation sequencing NGS is specific technology that conducts the test very quickly and can look at many genes at once.

NGS panels are made to find changes in genes variants that might show more risk to certain cancers, including inherited form s of cancer. NGS panels report a huge volume of data. However, it is not known how to use the data to make medical decisions.

Often a lot of unusable data is reported. Genetic panels that use NGS are considered investigational and unproven. The health plan does not pay for investigational services. Interpreting the results of genetic tests and understanding risk factors can be very difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members.

It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods Commercially available cancer susceptibility gene panels can test for multiple variants associated with a specific type of cancer or can include variants associated with a wide variety of cancers.

It has been proposed that variant testing using next - generation sequencing technology to analyze multiple genes at one time panel testing can optimize genetic testing in these patients compared with sequencing single genes. Genetic Testing for Cancer Susceptibility Genetic testing for cancer susceptibility may be approached by a focused method that involves testing for well-characterized variants based on a clinical suspicion of which gene s may be the cause of the familial cancer.

Panel testing involves testing for multiple variants in multiple genes at one time. NGS refers to one of several methods that use massively parallel platforms to allow the sequencing of large stretches of DNA. Panel testing is potentially associated with greater efficiencies in the evaluation of genetic diseases; however, it may provide information on genetic variants of uncertain clinical significance or which would not lead to changes in patient management. Currently available panels do not include all genes associated with hereditary cancer syndromes.

Also, these panels do not test for variants ie, single-nucleotide variants [SNVs] , which may be associated with a low, but increased cancer risk. 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.

Because larger and longer medical studies are needed, this technique is considered investigational unproven for other types of tumors. 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. Adjuvant radiation therapy decreases local recurrences, particularly for those who select lumpectomy. 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.

However, based on clinical input, cryosurgical ablation of benign breast fibroadenomas is considered medically necessary when criteria are met.

Coding Medically Necessary Code Description CPT 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 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 G 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.

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 , or during routine lumbar or cervical laminectomy or fusion AANEM, a 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 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 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. 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. Devices for transcranial magnetic stimulation have not been approved by the FDA for this use. 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. 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.

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. 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. 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 ABA is considered to be not medically necessary for any other conditions.

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. 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.

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.

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. In other states that specifically license agencies for ABA, ABA services may be provided by an agency that is so licensed. 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. 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 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. 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.

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

However, for Comprehensive ABA, more complex cases, or cases in which a complete functional analysis is needed, may require up to hours for the initial assessment and treatment planning. 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. Functional analysis re-assessments, when determined to be appropriate, are generally conducted once every 6 to 12 months.

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 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. 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. 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.

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 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.

Also, although 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 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.

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.

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

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 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 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 GD 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. As genetic science advances rapidly into this field, investigators are encountering new orders of magnitude of complexity. Despite the milestones achieved since , 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. Coding In , the CPT codes combined the kyphoplasty procedure with all of the necessary imaging guidance; they are listed in the table below. Code Description CPT 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 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 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 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. Percutaneous radiofrequency kyphoplasty or percutaneous mechanical vertebral augmentation using any other device is considered investigational.

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.

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. 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 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. 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. 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. For individuals who have osteoporotic or osteolytic vertebral compression fractures who receive radiofrequency kyphoplasty, the evidence includes a systematic review and an RCT.

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.

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. Background Most spinal visualization methods use x-rays to create images either on film, video monitor, or computer screen.

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.

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. 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. 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. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

Processing of scans by Ortho Kinematics is charged separately. Code Description CPT Electrical stimulation to aid bone healing; noninvasive non-operative Electrical stimulation to aid bone healing; invasive operative HCPCS E Osteogenesis stimulator, electrical, noninvasive, other than spinal applications E 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. 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.

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.

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. Congenital pseudarthrosis of the tibia has been linked to Type 1 neurofibromatosis but the exact cause of CPT is unknown. In contrast, fracture nonunion described below serial radiographsshow no evidence of healing.

The original U. 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.

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.

Most fresh closed fractures heal without complications with the use of standard fracture care ie, closed reduction and cast immobilization.

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This Agreement will terminate upon notice to you if you violate the terms of this Agreement. The ADA is a third-party beneficiary to this Agreement. The scope of this license is determined by the ADA, the copyright holder. End users do not act for or on behalf of the CMS. IVR: A — Billing and Coding: Allergy Immunotherapy. Group 1: , , , , , , , , , Group 2: , , , , , , , , , , A — Billing and Coding: Blepharoplasty.

Group 1: , , , , , , , , , , , , , , , , , , Group 2: C, J, J, J, J, J A — Billing and Coding: Botulinum Toxins. Group 1: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , G Group 2: , , , , , , , , , , , , , , , , , , , , , , , Group 3: G A — Billing and Coding: Cataract Extraction.

A — Billing and Coding: Chiropractic Services. A — Billing and Coding: Debridement Services. A — Billing and Coding: Endoscopy by Capsule.

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We convert your members into savvy health care shoppers as they take on greater financial responsibility for their care. Armed with more awareness of their treatment options and the cost of care, they can confidently participate in shared decision-making. We speak your language so you can count on our deep industry expertise to free up your teams to focus on other priorities. Market knowledge that includes work with government, exchange, employer and union populations.

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Employers and labor organizations Find our solutions. Health systems and providers Find our solutions. Have you heard the news? Applicable federal and state coverage mandates take precedence over these clinical guidelines. The AIM Clinical Appropriateness Guidelines for Site of Care address the medical necessity of advanced imaging performed at a hospital outpatient department.

To open our guidelines, your computer needs Adobe Reader, a free and trusted software that allows you to view PDFs. The Guidelines and Pathways are designed to evaluate and direct the appropriate utilization of certain health care services. They are based on data from peer-reviewed scientific literature, from criteria developed by specialty societies, and from guidelines adopted by other health care organizations.

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