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Policy governs coverage decisions for implantable and semi-invasive (semi-implantable) electrical bone growth stimulators used in the appendicular skeleton for delayed union, nonunion, fresh fractures, and as adjunct to spinal fusion where applicable; distinguishes Medicare Advantage and commercial product coverage.
Policy updated with last review date 05/03/2023; maintains prior coverage positions.
This policy governs coverage for implantable and semi-invasive (semi-implantable) electrical bone growth stimulators used in the appendicular skeleton (bones of the shoulder girdle, arms, pelvis, and legs) for delayed union, nonunion, fresh fractures, and as an adjunct to spinal fusion where applicable. The policy takes a mixed coverage stance: Medicare Advantage covers invasive (implantable) stimulators per the CMS NCD, while for Commercial products implantable stimulators are considered not medically necessary due to insufficient evidence. Semi-invasive (percutaneous electrode) stimulators are not covered (no FDA-approved devices identified and evidence insufficient).
Key policy thresholds include: nonunion timing >= 6 months without healing to define nonunion, and a requirement for serial radiographs consisting of a minimum of 2 sets of radiographs separated by >= 90 days to document nonunion per the CMS NCD.
Medicare Advantage (implantable/invasive stimulators)
Covered when ALL of the following Medicare NCD conditions are met:
ALL of the following
Per CMS NCD
Effective July 1, 1996 (CMS NCD)
| 20975 | Electrical stimulation to aid bone healing; invasive (operative) |
| E0749 | Osteogenesis stimulator, electrical, surgically implanted |
Radiographic documentation for Medicare coverage
Per the CMS National Coverage Determination for osteogenic stimulators, provide at least 2 sets of serial radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days to document nonunion and support initiation of treatment under Medicare Advantage.
Use appropriate invasive stimulator codes for Medicare Advantage
When invasive (implantable) electrical bone growth stimulators are covered under Medicare Advantage, report the invasive stimulator procedure and device using the appropriate CPT and HCPCS codes listed in the policy.
Electrical stimulation for bone healing has been studied in implantable (invasive) devices—where electrodes and a current generator are surgically implanted and the generator typically remains functional for 6 to 9 months—and in semi-invasive (semi-implantable) devices that use percutaneous electrodes with an external power supply; no FDA-approved semi-invasive devices were identified.
The available evidence for implantable and semi-invasive electrical bone growth stimulation is limited, comprising primarily small case series and a small number of trials. For commercial coverage, the evidence base is considered insufficient to determine effects on health outcomes, and therefore implantable stimulators are deemed not medically necessary for Commercial Products.
Medicare Advantage coverage differs because CMS has a National Coverage Determination (NCD) that specifies covered indications for invasive stimulators (including nonunion of long bone fractures and selected adjunct use in spinal fusion) and documents exact timing and radiographic documentation requirements for coverage.
| NCD Number | Name | Type | Effective Date |
|---|---|---|---|
| 150.2 | Osteogenic Stimulators | NCD |
Policy updated with last review date 05/03/2023; maintains prior coverage positions.
Effective September 15, 1980 (CMS NCD)
Effective April 1, 2000 (CMS NCD)
Commercial Products (implantable stimulators)
Covered when ALL of the following are met:
BCBSRI position: considered not medically necessary; evidence insufficient to determine effects on health outcomes
Medicare Advantage Plans and Commercial Products (semi-invasive stimulators)
Coverage statement:
Not covered — evidence insufficient; no FDA-approved semi-invasive devices identified