The Company has delegated the responsibility for utilization management activities for noninvasive electrical bone growth stimulators for bone healing after spinal fusion procedures including cervical, thoracic, and lumbar regions to Carelon Medical Benefits Management. Carelon utilizes their Clinical Appropriateness Guidelines for Musculoskeletal Spine Surgery to determine the medical necessity of noninvasive electrical bone growth stimulators following spinal surgery.
This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.
ELECTRICAL BONE GROWTH STIMULATORS
MEDICALLY NECESSARY
Non-Spinal
Electrical bone growth stimulators are considered medically necessary and, therefore, covered when any of the following criteria are met:
- A nonunion fracture of a long bone (i.e., clavicle, humerus, radius, ulna, metacarpal, femur, tibia, fibula, metatarsal)
- Nonunion fracture is defined as the point at which healing has stopped and further healing has ceased for 3 or more months (as evidenced by serial radiographic documentation, including a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days) prior to starting treatment with the bone growth stimulator
- A fracture secondary to congenital pseudarthrosis
- A failed surgical fusion of a joint other than in the spine when a minimum of 9 months have elapsed since the last surgery
NOT MEDICALLY NECESSARY
All other uses for electrical bone growth stimulators are considered not medically necessary and, therefore, not covered.
EXPERIMENTAL/INVESTIGATIONAL
Semi-invasive electrical bone growth stimulators are not approved by the US Food and Drug Administration (FDA) and are considered experimental/investigational and, therefore, not covered.
ULTRASONIC OSTEOGENESIS STIMULATOR
MEDICALLY NECESSARYAn ultrasonic osteogenesis stimulator is considered medically necessary and, therefore, covered when all of the following criteria are met:
- Nonunion bone fracture (e.g., clavicle, scapula, humerus, radius, ulna, carpal, metacarpal, phalanges [fingers or toes], femur, patella, tibia, fibula, malleolus, talus, calcaneus, cuboid, navicular, cuneiform, tarsal, metatarsal, rib(s), sternum, and pelvis), prior to any surgical intervention
- Nonunion fracture is defined as the point at which healing has stopped and further healing has ceased for 3 or more months (as evidenced by serial radiographic documentation, including a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days) prior to starting treatment with the bone growth stimulator.
- The fracture is not of the skull or vertebrae
- The fracture is not tumor related
NOT MEDICALLY NECESSARYAn ultrasonic
osteogenesis stimulator is considered not medically necessary and, therefore, not covered for all other indications, including but not limited to the following:
- Concurrent use with another noninvasive osteogenic stimulator
- Treatment of fresh fractures
- Treatment of delayed union fractures
SUPPLIES
Ultrasound conductive coupling gel is billed using code A4559.
FACE-TO-FACE REQUIREMENTS
As a condition for payment, a professional provider must have a face-to-face encounter with the individual for whom the item is ordered that meets all of the following requirements:
- The treating professional provider must have an in-person encounter with the individual within the 6 months prior to the date of the written order prior to delivery.
- This encounter must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of durable medical equipment (DME) ordered.
A new face-to-face encounter is required each time a new standard written order for one of the specified items is ordered. A new standard written order is required:
- For all claims for purchases or initial rentals
- When there is a change in the standard written order for the accessory, supply, drug, etc.
- If periodic standard written order renewal required per medical policy
- When an item is replaced
- When there is a change in the supplier
In this policy the specified items are:
| Code | Narrative |
| E0747 | Osteogenesis stimulator, electrical, noninvasive, other than spinal applications |
| E0760 | Osteogenesis stimulator, low intensity ultrasound, noninvasive |
REQUIRED DOCUMENTATION
The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:
STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.
PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.
CONSUMABLE SUPPLIES
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 14 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 10 days before the individual would exhaust their on-hand supply.
For specified DME items, documentation of a face-to-face encounter, between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s), must be provided to and kept on file by the DME supplier.
If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.
