CSHCS - Covered Benifits, renewal of coverage


Covered BENEFITS

CSHCS covers services that are medically necessary, related to the beneficiary’s qualifying diagnosis(es), and ordered by the beneficiary’s CSHCS authorized specialist(s) or subspecialist(s). Services are covered and reimbursed according to Medicaid policy unless otherwise stated in this chapter.

The primary CSHCS benefits may include:

* Ambulance

* Care Coordination*

* Case Management*

* Dental (Specialty and General)

* Dietary Formulas (limited)

* Durable Medical Equipment (DME)

* Emergency Department (ED)

* Hearing and Hearing Aids

* Home Health (intermittent visits)

* Hospice*

* Hospital at approved sites (Inpatient/Outpatient)

* Laboratory Tests

* Medical Supplies

* Monitoring Devices (Nonroutine)

* Office Visits to CSHCS Authorized Physicians


* Orthopedic Shoes

* Orthotics and Prosthetics

* Parenteral Nutrition

* Pharmacy

* Physical/Occupational/Speech Therapy

* Radiological Procedures

* Respite*

* Telemedicine

* Transplants and Implants

* Vision

(* Refer to the information and authorization requirements stated in this Section.)





PARTIAL MONTH COVERAGE


If a beneficiary enters or leaves a facility that is not a covered facility (e.g., nursing facility, or intermediate care facility) during a month of eligibility, the beneficiary remains a beneficiary for the remainder of that month. However, services provided to the beneficiary while in the facility are not covered (i.e., reimbursable) by CSHCS as these facilities are responsible for providing the medical care. (Refer to the General Information for Providers Chapter in this manual for additional information for beneficiaries who also have Medicaid coverage.)


RENEWAL OF COVERAGE


The beneficiary’s coverage may be renewed as needed if all eligibility criteria continue to be met and thefamily completes the renewal process. Medical review reports are required according to the timeframes  established based on the primary diagnosis for the beneficiary. An annual financial review is also required. If all of the criteria continue to be met for CSHCS coverage, a new coverage period is typically issued in 12-month increments.

CPT 0069U, 81229, 81327, 81407 - Miscellaneous Genetic and Molecular Diagnostic Tests

Code Description CPT

0069U Oncology (colorectal), microrna, rt-pcr expression profiling of mir-31-3p, formalinfixed paraffin-embedded tissue, algorithm reported as an expression score

81229 Cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities

81327 SEPT9 (Septin9) (eg, colorectal cancer) methylation analysis

81407 Molecular pathology procedure, Level 8 (eg, analysis of 26-50 exons by DNA sequence analysis, mutation scanning or duplication/deletion variants of >50 exons, sequence analysis of multiple genes on one platform)

81479 Unlisted molecular pathology procedure

84999 Unlisted chemistry procedure




Miscellaneous Genetic and Molecular Diagnostic Tests

Introduction


There are many genetic tests. High-quality medical studies show certain genetic tests are helpful when diagnosing some conditions or guiding treatment. However, not all genetic tests have been well studied. In some cases, studies have shown that genetic tests aren’t useful in making a diagnosis or changing care. This policy lists a number of genetic tests where there is not enough evidence in published medical studies to show that they bring health benefits. These tests are 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.

Test Name Investigational

* Celiac PLUS * ColonSentry® * ColoVantage® * Crohn’s Prognostic * DecisionDx-Thymoma * DNA Methylation
Pathway Profile * Epi proColon®  * GI Effects® (Stool) * IBD sgi Diagnostic™  * ImmunoGenomic® Profile * Know Error™ * ResponseDX®: Colon * SEPT9 methylated DNA * TransPredict Fc gamma 3a

Coding


All of the tests listed in this policy are considered investigational and grouped according to the categories of genetic testing as outlined in Medical Policy 12.04.91 (General Approach to Genetic Testing; see Related Policies above): * Testing of an affected (symptomatic) individual’s germline to
benefit the individual (excluding reproductive testing) * Diagnostic testing * Prognostic testing * Therapeutic testing  Testing an asymptomatic individual to determine future risk of disease is considered investigational.  

Note: See Table 1 in Evidence Review for additional information about test names listed at the left.


Related Information
 


Genetic testing is considered investigational when criteria are not met, including when there is insufficient evidence to determine whether the technology improves the net health outcome.

Genetic Counseling

Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible impact of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Evidence Review

Description
 

There are numerous commercially available genetic and molecular diagnostic, prognostic, and therapeutic tests for individuals with certain diseases and or asymptomatic individuals with a future risk. This medical policy evaluates miscellaneous genetic and molecular diagnostic tests not addressed in a separate review. If a separate medical policy exists, then conclusions reached there supersede conclusions in this policy. The main criterion for inclusion in this policy is the limited evidence on the clinical validity for the test. As a result, these tests do not have clinical utility and the evidence is insufficient to determine the effect on health outcomes. The lack of


clinical utility of these tests is based on criteria outlined in a separate medical policy (see Related Policies).

Background


Tests that are assessed in this medical policy are listed in Table 1. Excluding reproductive testing, there are primarily three reasons why genetic and molecular tests might be useful to a person with a disease: diagnostic testing, prognostic testing, and therapeutic testing. A fourth reason would be testing that is done on an asymptomatic person to determine his/her future risk of developing the disease. 


Diagnostic Tests

Multiple Conditions

Single-nucleotide variants (SNVs) are the most common type of genetic variation, and each SNV represents a difference in a single nucleotide in the DNA sequence. Most commonly, SNVs are found in the DNA between genes and can act as biologic markers of genes and disease association. When SNVs occur within a gene or a gene regulatory region, they can play a more direct role in disease by affecting the gene’s function. SNVs may predict an individual’s response to certain drugs, susceptibility to environmental factors, and the risk of developing certain diseases.
DNA specimen provenance assays can be used to confirm that tissue specimens are correctly matched to the patient of origin. Specimen provenance errors may occur in up to 1% to 2% of pathology tissue specimens  and have serious negative implications for patient care if the error is not corrected. Analysis of DNA microsatellites from tissue specimens can be performed by analyzing long tandem repeats (LTR) and comparing the LTRs of the tissue specimen with LTRs from a patient sample.

Test Description: DNA Methylation Pathway Profile


The DNA Methylation Pathway Profile (Great Plains Laboratory) analyzes SNVs associated with certain biochemical processes, including methionine metabolism, detoxification, hormone imbalances, and vitamin D function. Intended uses for the test include clarification of a diagnosis suggested by other testing and as an indication for supplements and diet modifications.


Test Description: Know Error DNA Specimen Provenance Assay


The Know Error test (Strand Diagnostics) compares the LTRs of tissue samples with LTRs from a buccal swab of the patient. The intended use of the test is to confirm tissue of origin and avoid specimen provenance errors due to switching of patient samples, mislabeling, or sample contamination.

Celiac Disease 


Previously called sprue, celiac sprue, gluten-sensitive enteropathy, gluten intolerance, nontropical sprue, or idiopathic steatorrhea, celiac disease is an immune-based reaction to gluten (water insoluble proteins in wheat, barley, rye) that primarily affects the small intestine. Celiac disease occurs almost exclusively in patients who carry at least 1 human leukocyte antigen DQ2 or DQ8; the negative predictive value of having neither allele exceeds 98%.

 Serum antibodies to tissue transglutaminase, endomysium, and deamidated gliadin peptide (DGP) support a diagnosis of celiac disease, but diagnostic confirmation requires duodenal biopsy taken when patients are on a gluten-containing diet.

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.

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