Vertical Expandable Prosthetic Titanium Rib

POLICY NUMBER

A.7.01.110

DESCRIPTION

The vertical expandable prosthetic titanium rib is a curved rod placed vertically in the chest to help shape the thoracic cavity. It is being evaluated in skeletally immature pediatric individuals with thoracic insufficiency syndrome to support thorax and lung development, and in pediatric individuals with scoliosis without thoracic insufficiency syndrome to slow or correct curve progression.

Vertical Expandable Prosthetic Titanium Rib

While spinal fusion is an approach to treatment in individuals with thoracic insufficiency syndrome, or early-onset scoliosis without thoracic insufficiency syndrome, the procedure may not be successful and may limit growth (lengthening) of the spine.

The vertical expandable prosthetic titanium rib device is a curved rod placed vertically 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. The vertical expandable prosthetic titanium rib may be described as “rib based” growth-sparing instrumentation, which is compared with “spine based” growing rods for Cobb angle correction. The vertical expandable prosthetic titanium rib device is designed to be expanded every four to six months as growth occurs and to be replaced if necessary. Some patients require multiple devices.

The VEPTR™ (DePuy Synthes Spine, Raynham, MA) was initially cleared (in 2004) for marketing by the U.S. Food and Drug Administration (FDA) through a humanitarian device exemption for the treatment of thoracic insufficiency syndrome in skeletally immature patients. In 2014, the VEPTR/VEPTR II™ was cleared for marketing by the FDA through the 510(k) process. The VEPTR/VEPTR II devices are indicated for skeletally immature patients with severe progressive spinal deformities and/or 3-dimensional deformity of the thorax associated with or at risk of thoracic insufficiency syndrome. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.

To identify potential individuals with thoracic insufficiency syndrome, the following categories are used:

• Flail chest syndrome;

• Rib fusion and scoliosis; and

• Hypoplastic thorax syndrome, including:

  • Jeune syndrome,

  • Achondroplasia,

  • Jarcho-Levin syndrome, and

  • Ellis-van Creveld syndrome.

In 2024, the RESPONSE™ Rib and Pelvic System (OrthoPediatrics, Warsaw, Indiana) was deemed substantially equivalent to the VEPTR device by the FDA (K233105).

POLICY

Use 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 and children between 6 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 individuals without thoracic insufficiency, is considered investigational.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Due to complexity of thoracoplasty and the young age of the individuals undergoing such a procedure, implantation of the vertical expandable prosthetic titanium rib should be performed in specialized centers. Preoperative evaluation should require input from a pediatric orthopedist, a pulmonologist, and a thoracic surgeon. In addition, preoperative evaluation should require (when possible) a test for positive nutritional, cardiac, and pulmonary function.

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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

3/27/2007: 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 A.7.01.110 added.

12/05/2016: Policy description updated. Policy statements unchanged.

09/15/2017: Policy description updated. Policy statements unchanged. Policy Guidelines updated regarding VEPTR thoracoplasty.

05/08/2018: Policy reviewed; no changes.

05/10/2019: Policy reviewed; no changes.

05/28/2020: Policy description updated regarding devices. Policy statements unchanged.

07/14/2021: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

05/27/2022: Policy reviewed; no changes.

05/11/2023: Policy description updated regarding spinal fusion and devices. Policy statements and Policy Guidelines updated to change "patients" to "individuals."

05/16/2024: Policy description updated regarding devices and to change "patients" to "individuals." Policy statements unchanged.

05/07/2025: Policy description updated regarding devices. Policy statements unchanged.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 7.01.110

CODE REFERENCE

This 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.

Covered Codes

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