Medical Policy Bulletin

For any item to be covered, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

A thoracic-lumbar-sacral orthosis (L0450-L0492), lumbar orthosis (L0625-L0627) or lumbar-sacral orthoses (L0628-L0640) is covered when it is ordered for one of the following indications:

1. To reduce pain by restricting mobility of the trunk; or
2. To facilitate healing following an injury to the spine or related soft tissues; or
3. To facilitate healing following a surgical procedure on the spine or related soft tissue; or
4. To otherwise support weak spinal muscles and/or a deformed spine.

If a spinal orthosis is provided and the coverage criteria are not met, the item will be denied as not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and be available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected procedure code.

Reasons for Noncoverage

Elastic support garments do not meet the statutory definition of a brace because they are not rigid or semi-rigid devices. Therefore, flexible spinal support garments that are made primarily of elastic material (e.g., neoprene or spandex [elastane, Lycra™, A4466]) will be denied as non-covered. Flexible spinal orthoses that are made primarily of nonelastic material (e.g., canvas, cotton or nylon) or that have a rigid posterior panel remain eligible for coverage. A provider can bill the member for the non-covered service.

Effective for claims with dates of service on or after July 1, 2010, spinal orthoses which have not received coding verification review from the Pricing, Data Analysis, and Coding (PDAC) contractor will be denied as statutorily non-covered. A provider can bill the member for the non-covered service.

A protective body sock (L0984) does not meet the definition of a brace and is non-covered. A provider can bill the member for the non-covered service.

There is no separate payment if CAD-CAM technology is used to fabricate an orthosis. Reimbursement is included in the allowance of the codes for custom fabricated orthoses.

Payment for a spinal orthosis is included in the payment to a hospital of SNF if:

The orthosis is provided to a patient prior to an inpatient hospital admission or Part A covered SNF stay; and
The medical necessity for the orthosis begins during the hospital or SNF stay (e.g., after spinal surgery).

A claim should not be submitted in this situation.

Payment for a spinal orthosis is also included in the payment to a hospital or a Part A covered SNF stay if:

The orthosis is provided to a patient during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; and
The patient uses the item for medically necessary inpatient treatment or rehabilitation.

A claim must not be submitted in this situation.

Payment for a spinal orthosis delivered to a patient in a hospital or a Part A covered SNF stay is eligible for coverage if:

The orthosis is medically necessary for a patient after discharge from a hospital Part A covered SNF stay; and
The orthosis is provided to the patient within two days prior to discharge to home; and
The orthosis is not needed for inpatient treatment or rehabilitation, but is left in the room for the patient to take home.

A flexible garment which is made primarily of elastic material (e.g., neoprene or spandex [elastane, Lycra™ ]), is billed with code A4466. These items were previously billed with code L0450, L0454, L0625, or L0628 and the GY modifier.

Codes L0450, L0454, L0625, and L0628 may only be used for orthoses that are made primarily of nonelastic material (e.g., canvas, cotton or nylon) or that have a rigid posterior panel.

The CG modifier must be added to code L0450, L0454, L0625, or L0628 only if it is one made primarily of nonelastic material (e.g., canvas, cotton or nylon) or has a rigid posterior panel.

L0452, L0478-L0486, L0629, L0632, L0634, L0638 and L0640 describe custom fabricated orthoses. These codes must not be used for prefabricated/custom fitted orthoses.

There is no separate billing if CAD-CAM technology is used to fabricate an orthosis.

Effective for claims with dates of service on or after July 1, 2010, the only products that may be billed with codes L0450, L0454-L0472, L0488-L0492, L0625-L0628, L0630. L0631, L0633, L0635, L0637 and L0639 for prefabricated orthoses are those that are specified in the Product Classification List on the Pricing, Data Analysis, and Coding (PDAC) contractor web site.

There are two categories custom fabricated spinal orthoses (codes L0452, L0480-L0486, L0629, L0632, L0634, L0636, L0638, and L0640):

Orthoses that are custom fabricated by a manufacturer/central fabrication facility and then sent to someone other than the patient. Effective for claims with dates of service on or after July 1, 2010, these items may be billed using one of these codes only if they are listed in the Product Classification List on the PDAC web site.
Orthoses that are custom fabricated from raw materials and are dispensed directly to the patient by the entity that fabricated the orthosis. These items do not have to be listed on the PDAC web site in order to be billed using a custom fabricated spinal orthosis code. However, the supplier must provide a list of the materials that were used and a description of the custom fabrication process on request.

Effective for claims with dates of service on or after July 1, 2010, prefabricated spinal orthoses and spinal orthoses that are custom fabricated by a manufacturer/central fabrication facility which have not received coding verification review from the PDAC must be billed with code A9270.

Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.

Term	Description
Body Jacket Type Orthoses	In addition to (1) and (2)of the thoracic-lumbar-sacral orthosis, the body jacket type orthoses (L0458-L0464, L0480-L0492, L0639-L0640) are characterized by a rigid plastic shell that encircles the trunk with overlapping edges and stabilizing closures and provides a high degree of immobility. The entire circumference of the plastic shell must be the same rigid material.
Coronal Control	Coronal control is achieved by a rigid panel in the mid-axillary line which is either an integral part of a posterior or anterior panel or a separate panel. Transverse control is achieved by one of several possible structural features: A rigid panel in the upper sternal area which is an integral part of an anterior shell, or A rigid panel in the upper sternal area which is rigidly attached to rigid abdominal or posterior panel, or Rigid extensions from a rigid posterior panel to the upper anterior chest bilaterally. Straps over the shoulders attaching to a posterior panel do not provide transverse control.
Custom Fabricated Orthosis	A custom fabricated orthosis is one which is individually made for a specific patient (no other patient would be able to use this orthosis) starting with basic materials including, but no limited to, plastic, metal, leather, or cloth in the form of sheets, bars, etc. It involves substantial work such as vacuum forming, cutting, bending, molding, sewing, etc. It requires more than trimming, bending, or making other modifications to a substantially prefabricated item. A molded-to-patient-model orthosis is a particular type of custom fabricated orthosis in which either: An impression of the specific body part is made (usually by means of a plaster or fiberglass cast) and this impression is then used to make a positive model (usually of plaster) of the body part; or Detailed measurements are taken of the patient’s torso and are used to modify a positive model (which has been selected from a large library of models) to make it conform to the patient’s body shape and dimensions; or A digital image of the patient’s torso is made using computer (CAD-CAM) software which then directs the carving of a positive model. The orthosis is then individually fabricated and molded over the positive model of the patient. There is no separate billing if CAD-CAM technology is used to fabricate an orthosis.
Prefabricated Orthosis	A prefabricated orthosis is one which is manufactured in quantity without a specific patient in mind. It is preformed with a shape that generally conforms to the body part. A prefabricated orthosis may be trimmed, bent, molded (with or without heat), or otherwise modified for use by a specific patient (i.e., custom fitted). A preformed orthosis is considered prefabricated even if it requires the attachment of straps and/or the addition of a lining and/or finishing work. Multiple measurements may be taken of the body part to determine which stock size of a prefabricated orthosis will provide the best fit. An orthosis that is assembled from prefabricated components is considered prefabricated. Any orthosis that does not meet the definition of a custom fabricated orthosis is considered prefabricated.
Sagittal Control	Sagittal control is achieved by a rigid posterior panel.
Spinal Orthosis	A spinal orthosis can be designed to control gross movement of the trunk and intersegmental motion of the vertebrae in one or more planes of motion: Lateral/flexion (side bending) in the coronal/frontal plane, flexion (forward bending) or extension (backward bending) in the sagittal plane and axial rotation (twisting) in the transverse plane. If the product does not provide control of motion in one or more planes or does not provide intracavitary pressure, then the item is not considered a spinal orthosis and should be coded as A9270. The provider cannot bill the member for the non-covered service.
Thoracic–Lumbar-Sacral Orthoses	Thoracic-lumbar-sacral orthoses (TLSO) described by codes L0450-L0492, lumbar orthoses (LO) described by codes L0625-L0627 and lumbar-sacral orthoses (LSO) described by codes L0628-L0640 have the following characteristics: 1. Used to immobilize the specified areas of the spine. 2. Intimate fit and generally designed to be worn under clothing. 3. Not specifically designed for patients in wheelchairs. For an item to be classified as a TLSO the posterior portion of the brace must extend from the sacrococcygeal junction to just inferior to the scapular spine. This excludes elastic or equal shoulder straps or other strapping. The anterior must at a minimum extend from the symphysis pubis to the xiphoid. Some TLSOs may require the anterior portion to extend up to the sternal notch.