CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

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

This policy governs coverage for implantable and semi-invasive (semi-implantable) electrical bone growth stimulators used in the appendicular skeleton, specifying different stances for BlueCHiP for Medicare and Commercial products and noting that semi-invasive devices are not covered.

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 DateOct 1, 2017

Next Review DateN/A

Key ActionFor Medicare members, confirm CMS NCD criteria (nonunion after ≥6 months and required serial radiographs) are met to support coverage for implantable stimulators.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2product categories

1Medicare covered code

Not coveredCommercial stance

CMSNCD referenced

Coverage Criteria: Implantable and Semi-implantable Stimulators

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Product-specific coverage

Coverage varies by product:

BlueCHiP for Medicare coverage

ALL of the following
- Nonunion of long bone fractures (nonunion defined as failure to heal after 6 or more months).
- Serial radiographs showing the fracture site with a minimum of 2 sets of radiographs, each including multiple views, separated by at least 90 days.
- Use as an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple-level fusion (3 or more vertebrae).

Commercial products: Implantable electrical bone growth stimulator is considered not medically necessary because evidence is insufficient; semi-invasive (semi-implantable) stimulators are not covered as no FDA-approved devices exist.N/A

Commercial stance in chunk 5 and semi-invasive note in chunk 6

The policy excludes semi-invasive (semi-implantable) electrical bone growth stimulators. No FDA-approved semi-invasive devices were identified and, accordingly, there is no billing code for semi-invasive stimulators. Claims for semi-invasive stimulators are therefore not covered.

For Commercial products, the implantable (invasive) electrical bone growth stimulator is considered not medically necessary because the evidence is insufficient to determine its effect on health outcomes. Note that CPT/HCPCS codes associated with implanted stimulators (e.g., 20975, E0749) are identified in the coding section as not medically necessary for Commercial members.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization and Coding Note

Prior authorization: Not applicable.

Affected codes: 20975, E0749

Documentation Required

Medicare NCD-based Requirements

CMS has a National Coverage Determination (NCD) that Medicare follows. The invasive (implantable) electrical bone growth stimulator is covered by Medicare only for specified indications: nonunion of long bone fractures and as an adjunct to spinal fusion for high-risk patients (previous failed fusion at same site or multiple-level fusion involving 3+ vertebrae). Nonunion of long bone fractures is defined as present only after 6 or more months without healing, and when starting treatment with the stimulator, serial radiographs must include a minimum of 2 sets of multiple views separated by at least 90 days.

Nonunion of long bone fractures (must be ≥ 6 months without healing)
Adjunct to spinal fusion for patients at high risk of pseudarthrosis: prior failed spinal fusion at same site or multiple-level fusion (≥ 3 vertebrae)
Serial radiographs: minimum of 2 sets, each with multiple views, separated by ≥ 90 days

Documentation Required

Medicare Documentation Requirements

For Medicare coverage of invasive (implantable) stimulators, documentation must include serial radiographs: a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by at least 90 days. Maintain records demonstrating the timing and findings of these radiographs and clinical documentation establishing nonunion per the NCD criteria.

Minimum 2 sets of radiographs with multiple views
Sets must be separated by ≥ 90 days
Clinical documentation showing ≥ 6 months without healing when claiming nonunion

Denial Risk

Denial Triggers for Commercial Products

Commercial products: implantable electrical bone growth stimulator is considered not medically necessary due to insufficient evidence. Semi-invasive stimulators are not covered (no FDA-approved device / no code).

Implantable stimulator (Commercial): Not medically necessary
Semi-invasive stimulator: Not covered — no FDA-approved device and no specific code

Background and Evidence Summary

Electrical stimulation (implantable or semi-invasive) has been investigated for delayed union, nonunion, and fresh fractures of the appendicular skeleton, with primary clinical experience in tibial fractures. Implantable devices deliver constant direct current at the fracture site and typically remain functional for approximately 6–9 months. There is no FDA-approved semi-invasive device, which limits coverage and coding options.

Definitions

Implantable electrical bone growth stimulator — definition and key facts

DefinitionSurgically implanted device with a cathode placed at the fracture or fusion site and a current generator implanted in an intramuscular or subcutaneous space; provides direct current stimulation.

Typical durabilityImplantable device typically remains functional for 6 to 9 months after implantation.

Generator managementThe current generator is usually removed in a second surgical procedure when stimulation is completed; the implanted electrode may or may not be removed.

Stimulation characteristicsProvides constant direct-current stimulation at the nonunion or fracture site but carries increased risks associated with implantable leads.

Clinical useUsed to treat nonunion, delayed union, and fractures of the appendicular skeleton (commonly tibial fractures).

Semi-invasive (semi-implantable) stimulator — definition and regulatory note

DefinitionDevice using percutaneous electrodes with an external power supply that avoids the need for surgical removal of a generator.

Regulatory statusNo semi-invasive (semi-implantable) electrical bone growth stimulator devices with FDA approval or clearance were identified.

Procedure implicationPercutaneous electrodes and external power supply obviate a second surgical procedure to remove a generator.

Comparative riskAvoids some risks of implanted leads but relies on percutaneous access, which has different infection and maintenance considerations.