Braces and supports are prosthetic or orthotic devices which steady, align, protect, or strengthen weakened, injured, or deformed body parts.

Custom fitted orthotics are prefabricated, may require some assembly, and are substantially modified for individual fitting at the time of delivery by a certified orthotist, or an individual with equivalent specialized training.

Substantial modifications are changes by a certified orthotist or an individual with equivalent specialized training in compliance with licensure and regulatory requirements to achieve an individualized fit using CAD/CAM technology.

Minimal self-adjustment can be performed by the member, and does not require expertise of a certified orthotist.

Off-the-shelf (OTS) orthotics are prefabricated, may require some assembly and/or minimal self-adjustment, but not requiring expertise of a certified orthotist.

DELAWARE MANDATE 18 Delaware Code Sections 3361 and 3571E:  Delaware law, which applies to risk (both individual and group policies) business only, requires insurers to cover certain custom orthotic and prosthetic devices.  Coverage must be provided for the most appropriate model that “adequately meets the medical needs of the patient”.  Further, reimbursement for orthotic and prosthetic devices must be made at the same level as the "federal reimbursement rates." The federal reimbursement rates are defined as those rates routinely promulgated by the Centers for Medicare and Medicaid Services.

DELAWARE MANDATE ORTHOSIS DEFINITION:
A custom fabricated brace or support that is designed based on medical necessity. Orthosis does not include prefabricated or direct-formed orthotic devices or any of the following assistive technology devices: commercially available knee orthoses used following injury or surgery; spastic muscle-tone inhibiting orthoses; upper extremity adaptive equipment; finger splints; hand splints; wrist gauntlets; face masks used following burns; wheelchair seating that is an integral part of the wheelchair and not worn by the patient independent of the wheelchair; fabric or elastic supports; corsets; low-temperature formed plastic splints; trusses; elastic hose; canes; crutches; cervical collars; dental appliances; and any other similar devices, as determined Secretary of the Department of Health and Social Services, commonly carried in stock by a pharmacy, department store, or surgical supply facility.

Braces and supports addressed in this medical policy may be considered medically necessary when ALL of the following general criteria are met, AND any category specific criteria:

General Criteria

• Appropriate for the individual's condition; and
• Is a rigid or semi-rigid device that:
  • Supports weak or deformed body part; or
  • Restricts or eliminates motion in diseased or injured body part; and
• Provides support and counterforce; and
• Is prefabricated or custom-fabricated; and
• Able to withstand long term use.

Devices not meeting the above criteria are considered not medically necessary.

Purchase of more than two (2) of the same type of device on the same day is considered not medically necessary.

Dispensing a device for post-operative use prior to the procedure is considered not medically necessary.

Hernia supports (corset or truss style) may be considered medically necessary when BOTH of the following criteria are met:

• General criteria; and
• Hernia is reducible.

Hernia supports (corset or truss style) are considered not medically necessary for all other indications.

Supportive back braces may be considered medically necessary when ANY ONE of the following are met: 

• General criteria are met; and
• To facilitate healing following an injury to the spine or related soft tissues; or
• To facilitate healing following a surgical procedure on the spine or related soft tissue; or
• To reduce pain by restricting mobility of the trunk; or
• To support weak spinal muscles and/or a deformed spine.

Supportive back braces are considered not medically necessary for all other indications.

Custom-fitted and custom-fabricated back braces may be considered medically necessary when criteria for supportive back braces AND ONE of the following are met:

• A prefabricated back brace modified to fit a specific individual is required due to failure, contraindication, or intolerance to an unmodified, prefabricated back brace; or
• As the initial brace after surgical stabilization of the spine following traumatic injury; or
• A custom-fabricated back brace (individually constructed to fit a specific individual from component materials) is required due to a failure, contraindication, or intolerance to a custom-fitted back brace.

Custom-fitted or custom-fabricated back braces are considered not medically necessary for all other indications.

Postoperative back braces may be considered medically necessary when ALL of the following are met: 

• General criteria are met; and
• It is considered part of the surgical protocol; and
• It will facilitate healing; and
• Is applied within six (6) weeks following a surgical procedure on the spine or related soft tissue.

Postoperative back braces are considered not medically necessary for all other indications.

Quantity Level Limits (QLL) for all back braces

One (1) back brace per every five (5) years may be considered medically necessary as the reasonable lifetime of a back brace is no less than five (5) years.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed above will be denied as not medically necessary.

Postoperative hip braces may be considered medically necessary after ANY ONE of the following procedures:

• Partial hip hemiarthroplasty; or
• Total hip arthroplasty; or
• Conversion of previous hip surgery to total hip arthroplasty; or
• Revision of total hip arthroplasty; or
• Osteotomy and transfer of greater trochanter of femur; or
• Arthroscopy with removal of loose body or foreign body, debridement or with synovectomy; or
• Arthroscopy with femoroplasty; or
• Arthroscopy with acetabuloplasty; or
• Arthroscopy with labral repair.

Postoperative hip braces are considered not medically necessary for all other indications.

Cast-braces (fracture braces)

Comfort, non-therapeutic cast-braces (Cam Walker) may be considered medically necessary when BOTH of the following criteria are met: 

• General criteria; and
• After a fracture or surgery.

Comfort, non-therapeutic cast-braces are considered not medically necessary for all other indications.

Functional cast-braces (patella tendon bearing [PTB] cast brace, PTB fracture brace, molded ankle-foot orthosis [MAFO], fracture brace with pelvic band, achilles tendon hinged brace) may be considered medically necessary when BOTH of the following criteria are met:

• General criteria; and
• After a fracture or surgery.

Functional cast-braces are considered not medically necessary for all other indications.

Rehabilitation braces may be considered medically necessary when ALL of the following criteria are met:

• General criteria; and
• Applied within six (6) weeks of surgery or injury.  

Rehabilitation braces are considered not medically necessary for all other indications.

Cervical (neck) braces may be considered medically necessary when ALL of the following criteria are met: 

• General criteria; and
• Neck injury is documented. 

Cervical (neck) braces are considered not medically necessary for all other indications.

Childhood hip braces (Pavlik harness, Frejka pillow splint, Friedman strap) may be considered medically necessary for children with hip disorders when ALL of the following criteria are met:

• General criteria; and
• To stabilize the hip; or
• To correct and maintain hip abduction.

Childhood hip braces are considered not medically necessary for all other indications.

Braces for congenital defects OR advanced neuromuscular conditions may be considered medically necessary when general criteria are met.

Replacement braces may be considered medically necessary when:

• The individual has outgrown the previous brace; or
• The condition has changed making the previous brace unusable.

Braces for congenital defects or advanced neuromuscular conditions are considered not medically necessary for all other indications not listed above.

Cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthoses may be considered medically necessary for the treatment of scoliosis in juvenile and adolescent individuals at high-risk of progression when ALL of the following criteria are met:

• General criteria; and
• Idiopathic spinal curve angle between 25 and 60 degrees; and
• Spinal growth has not been completed (Risser grade 0-3; no more than one (1) year post-menarche in females); or
• Idiopathic spinal curve angle greater than 20 degrees; and
• There is documented increase in the curve angle; and
• At least two (2) years growth remains (Risser grade 0 or 1; pre-menarche in females).

Cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthoses are considered not medically necessary for all other indications.

Wheaton braces may be considered medically necessary to treat metatarsus adductus in infants, replacing the need for serial casting when general criteria are met.

Wheaton braces are considered not medically necessary for all other indications. 

Splints and immobilizers - The following devices may be considered medically necessary when general criteria are met:

• Acromio-clavicular splint (Zimmer splint)
• Wrist extension control cock-up splint
• Clavicle splint (Figure-8 splint)
• Denis Browne splint (for children with clubfoot or metatarsus valgus to maintain and correct abduction)
• Finger splints
• Shoulder immobilizer

Splints and immobilizers are considered not medically necessary for all other indications.

Unna boots may be considered medically necessary for the following non-fracture care indications:

• To treat sprains and torn ligaments; or
• To provide protection for other soft tissue injuries; or
• As a protective cover to promote healing after certain surgical procedures. 

Unna boots are considered not medically necessary for all other indications.

Air casts/air splints may be considered medically necessary for treatment of fractures or other injuries (i.e., sprains, torn ligaments) when general criteria are met.

Air casts/air splints are considered not medically necessary for all other indications.

Miscellaneous covered services

Casting of a sprain or casting following a surgical procedure may be considered medically necessary.

Casting for all other indications is considered not medically necessary.

The following braces and supports do not meet the definition of covered durable medical equipment because they are not made to withstand long term use; and are therefore considered non-covered:

• Completely elastic supports (e.g., athletic supporter, joint supports, non-rigid trusses, etc.)
• Inflatable lumbar supports
• Protective body socks
• Cervical foam neck collars