Oscar Spinal Orthoses (Back Braces) (CG051) Form

The Plan

Members with conditions affecting the back or spine may be eligible for special types of back braces known as spinal orthoses. Spinal orthoses function by providing a rigid structure to stabilize, align, and/or support the spine. These devices can be used for a number of conditions, including spinal trauma, pain, spinal deformities, and for rehabilitation after certain surgical procedures.

Spinal orthoses come in several levels of customization, ranging from pre-fabricated to fully customized braces. They are also categorized based on which region(s) of the back they support (e.g., lumbosacral, thoracolumbosacral, etc.). These devices are considered durable medical equipment and must be prescribed by a licensed physician.

While there are a variety of orthotics for various sites of the body, this guideline is focused specifically on those used on the back.

Definitions

"Custom-fitted orthosis" is a pre-fabricated orthosis that has been modified, molded, or customized in order to better fit a specific individual.

"Custom-fabricated orthosis" is an orthosis designed from the ground up specifically for a specific individual. This is often done by taking a mold of the individual's anatomy or performing computer-aided mapping.

"LSO" or "Lumbosacral orthosis" is a type of spinal orthosis that is not as extensive as the TLSO, typically starting at the sacrococcygeal junction and extending to the mid back.

"Peak height velocity / peak growth velocity" describes the fastest growth period during puberty. It represents the risk of curve progression associated with rapid skeletal growth during maturation.

"Pre-fabricated orthosis" is one that is produced from pre-made components and is made to fit a number of body types without a specific individual in mind.

"Risser sign" is a scale used to define skeletal maturity using x-ray of the pelvis. This scale can be used to determine the trajectory of certain musculoskeletal conditions.

• Grade 0: ilium (bone) is 0% calcified;
• Grade 1: ilium (bone) is 25% calcified; often seen at pre-puberty or just at the start of puberty.
• Grade 2: ilium (bone) is 50% calcified; corresponds to growth.
• Grade 3: ilium (bone) is 75% calcified; slowing of growth.
• Grade 4: ilium (bone) is 100% calcified; growth is nearly stopped or stopping
• Grade 5: ilium (bone) is 100% calcified and the iliac apophysis is fused to iliac crest; growth has ended

"Sanders Maturity Scale" is based on a left hand radiograph that predicts the curve acceleration phase of growth and skeletal maturity.

"Scoliosis braces" include a number of different braces specifically designed for individuals with scoliosis, including but not limited to:

1. Boston scoliosis brace
2. Charleston scoliosis brace
3. Milwaukee scoliosis brace
4. Providence brace
5. Rigo-Cheneau or Wood-Cheneau Rigo brace
6. Risser jacket
7. SpineCor Dynamic Corrective brace

"Skeletal immaturity" refers to bones that have not yet reached full development. It is often measured by looking at the relative level of closure of the growth plates (ossification of the epiphysis) using x-ray and is important in determining the expected outcomes in the treatment of certain musculoskeletal conditions such as scoliosis. The Risser sign is a quantification of skeletal maturity using a five point grading scale, as defined below.

"Spinal orthosis" refers to brace-type of durable medical equipment that provides control of motion in one or more planes of movement of the back. In order to meet this definition, the brace must be rigid or semi-rigid and specifically designed to restrict or eliminate motion of the targeted region. These braces can be designed to wear over or under the clothing.

They are typically used as part of a comprehensive treatment plan that may also include physical and occupational therapy.

"Tanner-Whitehouse III method" determines skeletal maturity with hand and wrist bones with a maturity scoring system based on an atlas with individual bone scores (distal radius, distal ulna, small bones).

"TLSO" or "Thoracolumbosacral orthosis" is a type of spinal orthosis that by definition, must extend from the sacrococcygeal junction to just below the scapula. On the anterior side, it must extend from the pubic symphysis to the xiphoid.

Clinical Indications

Pre-Fabricated Spinal Orthoses

The Plan considers pre-fabricated spinal orthoses medically necessary when ANY of the following criteria are met:

1. Documented injury to the spine or surrounding soft tissue where stabilization is needed to prevent further injury or assist with healing; or
2. Within 6 weeks following a surgical procedure to the spine or surrounding soft tissue where stabilization is needed to prevent further injury or assist with healing; or
3. The need to support, stabilize, or correct spinal deformities (e.g., scoliosis), or weak/injured spinal musculature, or from idiopathic or neuromuscular origin; or
4. The need to support or stabilize the spine to control pain with documented spinal origin.

Custom-Fitted Spinal Orthoses

The Plan considers custom-fitted spinal orthoses medically necessary when ALL of the following criteria are met:

1. The above criteria for pre-fabricated spinal orthoses are met; and
2. ONE of the following conditions is met:
   • There is documented failure, contraindication, or inability to tolerate a medically necessary pre-fabricated spinal orthosis; or
   • For treatment of a spinal deformity (e.g., scoliosis, kyphosis) from idiopathic or neuromuscular origin (e.g., spina bifida, cerebral palsy, muscular dystrophy); or
   • For stabilization of the spine following traumatic injury; and
3. There is documentation of what modifications were made to the orthosis and why these changes were medically necessary for the individual’s specific condition.

Custom-Fabricated Spinal Orthoses

The Plan considers custom-fabricated spinal orthoses medically necessary when ALL of the following criteria are met:

1. The above criteria for pre-fabricated spinal orthoses are met; and
2. ONE of the following conditions is met:
3. There is documented failure, contraindication (e.g., due to the patient’s anatomy or deformity), or inability to tolerate a medically necessary pre-fabricated or custom-fitted spinal orthosis; or
4. For treatment of a spinal deformity (e.g., scoliosis, kyphosis) with skeletal immaturity as defined by Risser 0-3 and with Cobb angles between 25 and 50 degrees.

Scoliosis Spinal Orthoses

The Plan considers scoliosis-specific spinal orthoses medically necessary when ALL the following criteria are met:

1. The orthosis is one of the following:
   • Boston scoliosis brace
   • Charleston scoliosis brace
   • Milwaukee scoliosis brace
   • Providence brace
   • Rigo-Cheneau or Wood-Cheneau Rigo brace
   • Risser jacket
2. The individual meets the definition of skeletal immaturity (Risser 0-3); and
3. The severity of scoliosis falls into ONE of the following:
   • Greater than 25 degrees and less than 50 degrees; or
   • Between 20-25 degrees AND with an increase of 5 degrees within the past 6 months

Repair or Replacement of Spinal Orthoses

The Plan considers the repair or replacement of spinal orthoses medically necessary when ALL of the following criteria are met:

1. The original orthosis was medically necessary and is no longer under warranty; and
2. Clinical Indications Criteria above continue to be met; and
3. Repair, adjustment, or replacement is not being requested due to misuse, neglect, or abuse.
4. The member has grown, undergone anatomic changes, or experienced a new injury/procedure such that the orthosis is no longer functional; and
5. For repair or adjustment, there is reasonable expectation that it will make the equipment usable;

For repair or adjustment, it is generally expected to cost less than a complete replacement; and

Note:Certain orthopedic post-operative braces may be considered integral to the surgical procedure and not separately billable.

Experimental or Investigational / Not Medically Necessary

Depending on a member’s plan coverage restrictions, over-the-counter or off-the-shelf braces may not be a covered benefit.

Comfort or convenience items including, but not limited to the following are considered not medically necessary:

• Prophylactic elastic lumbar supports
• Inflatable lumbar support pillows/cushions
• Backrest supports
• Protective body socks
• Over-the-counter or off-the-shelf accessories

Spinal orthoses for any indication not meeting the clinical criteria above are considered not medically necessary. Non-covered indications include, but are not limited to, the following:

• Duplicative orthoses for use as a spare to an already medically necessary device
• Braces used for sports, work activities, or any indication other than supporting activities of daily living (ADLs)
• Braces used as a pre-operative diagnostic tool prior to spinal fusion surgery
• The following are specific contraindications to spinal orthotics in patients with scoliosis/kyphosis:

• Skeletal maturity (Risser sign 4 to 5 and iliac apophyses fused)
• Cobb angle > 50 degrees
• Cobb angle < 20 degrees
• Thoracic Lordosis (relative contraindication)

The following devices are considered experimental or investigational:

• Any brace or device not meeting the definition of "spinal orthosis" as outlined above, such as elastic garments or other non-rigid devices
  • Note: A flexible orthosis may be medically necessary if it has a rigid component.
• Thoracic rib belts, as there is no evidence they improve health outcomes in healing or pain.
• Self-unloading spinal devices or traction equipment
• DDS 500 lumbar traction LSO
• The following scoliosis braces:
  • Copes scoliosis brace
  • Rosenberger brace
  • ScoliBrace
  • SpineCor Dynamic Corrective Brace

The SpineCor Dynamic Corrective Brace has been proposed as an alternative to rigid bracing for scoliosis. Historically, the literature was conflicting on the potential benefit of this device. However, a 2014 prospective randomized controlled study on the treatment outcome of SpineCor brace versus rigid brace for adolescent idiopathic scoliosis examined females aged 10-14 with idiopathic scoliosis. They concluded that "curve progression rate was found to be significantly higher in the SpineCor group when compared with the rigid brace group". Other large retrospective studies, such as the recent analysis by Gutman et al, found that the SpineCor was inferior to the standard Boston brace. Because the existing data is limited to observational studies or otherwise negative data, the potential benefit of the SpineCor bracing system has not yet been validated and is therefore considered experimental and investigational.

ScoliBrace is a 3D customized back brace designed for infants to adolescents. There is one 2019 case study by Gubbels et al of ScoliBrace rigid thoracic-lumbar-sacral orthosis (TSLO) bracing in combination with a specific rehabilitation program in an adult patient with Kypho-scoliosis and adolescent idiopathic scoliosis. However, there is a lack of research studies for clinical utility of ScoliBrace in infants and adolescents.