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The vertical expandable prosthetic titanium rib (VEPTR) is a curved rod placed vertically in the chest that helps to shape the thoracic cavity. It is being evaluated for use in skeletally immature patients with thoracic insufficiency syndrome (TIS) and to slow or correct curve progression in pediatric patients with scoliosis without TIS.
Thoracic insufficiency syndrome (TIS) is the inability of the thorax to support normal respiration or lung growth. The condition results from serious defects affecting the ribs or chest wall, such as severe scoliosis or rib fusion, and various hypoplastic thorax syndromes, such as Jeune Syndrome and Jarcho-Levin syndrome. Spine, chest, and lung growth are interdependent. While the coexistence of chest wall and spinal deformity is well-documented, this effect on lung growth is not completely understood.
Progressive thoracic insufficiency syndrome includes respiratory insufficiency, loss of chest wall mobility, worsening three-dimensional thoracic deformity, and/or worsening pulmonary function tests. As a child grows, progressive thoracic deformity and rotation toward the concave side occurs with worsening respiratory compromise. This progression is often accompanied by a need for supplemental oxygen and can require mechanical ventilation. While spinal fusion is one approach to treatment, it may not be successful and also may limit growth (lengthening) of the spine.
The vertical expandable prosthetic titanium rib (VEPTR, Synthes Spine) is a curved rod placed horizontally in the chest that helps to stabilize and shape the thoracic cavity. It is positioned either between ribs or between the ribs and either the spine or pelvis. VEPTR may be described as “rib based” growth-sparing instrumentation, which is compared with “spine based” growing rods for Cobb angle correction. The VEPTR device is designed to be expanded every four to six months as growth occurs and also to be replaced if necessary. Some patients require multiple devices.
A VEPTR initially received FDA approval under a humanitarian device exemption (HDE) for the treatment of Thoracic Insufficiency Syndrome (TIS) in skeletally immature patients. TIS is defined as the inability of the thorax to support normal respiration or lung growth. In 2014, FDA cleared the VEPTR through the 510(k) process. The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe progressive spinal deformities and/or 3-dimensional deformity of the thorax associated with or at risk of TIS. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.
For the purpose of identifying potential TIS patients, the categories in which TIS patients fall are as follows:
This review also indicated that the device should not be used in patients younger than 6 months.
Use of the VEPTR in pediatric patients with scoliosis without TIS is an off-label indication.
POLICYUse of the Vertical Expandable Prosthetic Titanium Rib is considered medically necessary in the treatment of progressive thoracic insufficiency syndrome due to rib and/or chest wall defects in infants/children between six months of age and skeletal maturity.
Use of the vertical expandable prosthetic titanium rib for all other conditions, including but not limited to the treatment of scoliosis in patients without thoracic insufficiency, is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-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.
POLICY GUIDELINESSkeletal maturity occurs at about age 14 for girls and age 16 for boys.
Given the complexity of these procedures and patients, implantation of this device should be performed in specialized centers. Preoperative evaluation requires input from a pediatric orthopedist, pulmonologist, and thoracic surgeon. In addition, preoperative evaluation of nutritional, cardiac, and pulmonary function (when possible) is required.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/27/2007: Policy added
7/25/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
6/30/2008: Policy reviewed, no changes
12/30/1010: Policy reviewed; no changes.
12/01/2011: Policy reviewed; no changes.
07/12/2012: Policy description updated. Added the following policy statement: Use of the vertical expandable prosthetic titanium rib for all other conditions, including but not limited to the treatment of scoliosis in patients without thoracic insufficiency, is considered investigational. Added FEP verbiage to the Policy Exception section.
08/14/2013: Policy reviewed; no changes.
06/16/2014: Policy reviewed; description updated regarding TIS patient categories. Policy statement unchanged.
08/31/2015: Medical policy revised to add ICD-10 codes.
11/12/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross and Blue Shield Assoication Policy # 7.01.110
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.