CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Electrical Bone Growth Stimulation of the Appendicular Skeleton — Implantable and Semi-Implantable

Policy governs coverage and medical necessity determinations for implantable and semi-invasive (semi-implantable/percutaneous) electrical bone growth stimulators used in the appendicular skeleton for BCBSRI members and Medicare Advantage enrollees.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyElectrical Bone Growth Stimulation of the Appendicular Skeleton — Implantable and Semi-Implantable

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 10, 2017

Next Review DateAug 7, 2024

Key ActionFor Medicare Advantage, ensure documentation meets CMS NCD requirements for nonunion (>=6 months without healing and serial radiographs separated by ≥90 days).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2coverage stances (Medicare Advantage vs Commercial)

1CPT/HCPCS codes listed

6-9 motypical functional period for implantable device

>=6 moCMS nonunion definition

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Coverage by product and device type

Coverage decisions differ by product:

Medicare Advantage - Invasive (implantable) stimulators: Covered when CMS NCD criteria are met (examples include nonunion of long bone fractures after >= 6 months without healing with required serial radiographs separated by >= 90 days; adjunct to spinal fusion for high‑risk patients such as prior failed fusion or multiple‑level fusion).see CMS NCD

Policy states invasive stimulator is covered for Medicare Advantage per CMS NCD

Medicare Advantage - Semi-invasive (semi‑implantable) stimulators: Not covered (no CMS/FDA‑approved semi‑invasive devices identified and policy states semi‑invasive devices are not covered for Medicare Advantage).N/A

Policy explicitly states semi‑invasive not covered for Medicare Advantage

Commercial Products - Implantable stimulators: Considered not medically necessary; evidence is insufficient to determine the effect on health outcomes.N/A

Commercial coverage denial based on insufficient evidence

Commercial Products - Semi‑invasive (semi‑implantable) stimulators: Not medically necessary; evidence is insufficient to determine the effect on health outcomes and no FDA‑approved semi‑invasive devices identified.N/A

Policy states semi‑invasive stimulators are not medically necessary for Commercial Products

For Semi‑invasive (semi‑implantable) electrical bone growth stimulators, this policy states they are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products. The rationale is that no FDA‑approved semi‑invasive devices were identified and the available evidence is insufficient to determine an improvement in health outcomes for these devices.

For implantable (invasive) electrical bone stimulators, the policy differentiates by product line. For Commercial Products, implantable stimulators are considered not medically necessary because the evidence is insufficient to determine their effect on health outcomes. For Medicare Advantage, implantable stimulators are covered when CMS National Coverage Determination (NCD) criteria are met (see coding/thresholds and CMS NCD language); implantable devices deliver continuous stimulation and typically remain functional for about 6 to 9 months, often requiring a second procedure to remove the generator.

Coding and Definitions Relevant to Coverage

Medicare covered / Commercial not medically necessaryCPT | HCPCS

20975	Electrical stimulation to aid bone healing; invasive (operative)
E0749	Osteogenesis stimulator; electrical, surgically implanted

Nonunion definition per CMS — timing and radiograph requirements

Timing requirementNonunion of long bone fractures is considered to exist only after 6 or more months have elapsed without healing.

Radiographic documentationSerial radiographs must include a minimum of 2 sets, each with multiple views of the fracture site, separated by at least 90 days.

ApplicabilityDefinition applies when starting treatment with an electrical osteogenic (implantable) stimulator per CMS NCD.

Provider Actions, Documentation and Prior Authorization

Prior Authorization

Prior authorization — Not applicable per policy; Medicare Advantage follows CMS NCD requirements for invasive stimulators.

Documentation Required

CMS-required contextual criteria

CMS-required contextual criteria — Invasive (implantable) electrical bone growth stimulators are covered under the CMS National Coverage Determination (NCD) only for specific indications and with documentation requirements.

Covered indications per CMS NCD: adjunct to spinal fusion for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for multiple level fusion (3 or more vertebrae).
Nonunion of long bone fractures: nonunion is defined as failure to heal after ≥ 6 months without healing.
Radiographic documentation: Serial radiographs must include a minimum of 2 sets of radiographs, each with multiple views of the fracture site, separated by at least 90 days.

Denial Risk

Denial Triggers / Coverage Limits

Denial triggers for Commercial and semi-invasive devices — commercial implantable products and semi‑invasive stimulators are not covered or not medically necessary per policy.

Commercial Products: Implantable electrical bone stimulator — considered not medically necessary.
Medicare Advantage Plans and Commercial Products: Semi-invasive electrical bone growth stimulator — not covered for Medicare Advantage Plans and not medically necessary for Commercial Products.

Definitions: Invasive and Semi-invasive Stimulation

Invasive (implantable) stimulation — surgical implantation details and device behavior

ProcedureSurgical implantation of a cathode/electrode at the fracture site with a current generator implanted in an intramuscular or subcutaneous pocket.

Device behaviorProvides direct current electrical stimulation with constant stimulation at the nonunion or fracture site; generator typically remains functional for about 6 to 9 months.

Removal considerationsThe current generator is usually removed in a second surgical procedure after stimulation is completed; the electrode may or may not be removed.

RisksImplantable leads carry increased risks associated with implanted devices (e.g., surgical and device-related complications).

Semi-invasive (semi-implantable) stimulation — percutaneous electrodes with external power supply

DefinitionUse of percutaneous (semi-implantable) electrodes connected to an external power supply, avoiding implantation of an internal generator.

Generator removalExternal power supply obviates the need for a surgical procedure to remove an implanted generator when treatment is finished.

Clinical contextSemi-invasive approach avoids a second surgery for generator removal but involves percutaneous electrodes placed through the skin.

Background and Evidence Summary

Electrical stimulation has been studied to promote healing in fresh fractures, stress fractures, delayed union, nonunion, congenital pseudarthrosis, and arthrodesis of the appendicular skeleton. Two device approaches are described: invasive (implantable) systems that surgically place an electrode at the fracture site with an implanted current generator providing continuous direct current (the generator typically functions for 6 to 9 months and may be removed surgically afterward), and semi‑invasive (percutaneous) systems that use percutaneous electrodes with an external power source and avoid generator‑removal surgery. Available evidence consists largely of small case series and randomized trials with mixed results; BCBSRI finds the evidence insufficient to support commercial coverage of implantable devices and insufficient to support semi‑invasive devices.