CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy | Electrical Bone Growth Stimulation of the Appendicular Skeleton - Implantable and Semi-Implantable

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 Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy | Electrical Bone Growth Stimulation of the Appendicular Skeleton - Implantable and Semi-Implantable

Policy CodePolicy N/A

Change TypeClarified (no material change)

Effective Date10/01/2017

Next Review Date

Key ActionProvide at least 2 sets of serial radiographs (multiple views) of the fracture site separated by a minimum of 90 days to support nonunion and initiation of treatment; required per CMS NCD.

SourceLink

POLICY UPDATE CHANGES

Policy updated with last review date 05/03/2023; maintains prior coverage positions.

2HCPCS/CPT codes listed

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Coverage Summary

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.

Policy dates & quick facts

Effective date2017-10-01

Last review2023-05-03

StatusCURRENT

Scope summaryPolicy governs coverage for implantable and semi-invasive electrical bone growth stimulators of the appendicular skeleton (shoulder girdle, arms, pelvis, legs) for delayed union, nonunion, fresh fractures, and as adjunct to spinal fusion where applicable; distinguishes Medicare Advantage and commercial coverage.

HCPCS/CPT codes listed20975; E0749 (listed for Medicare Advantage; not medically necessary for Commercial)

High-level coverage splitMedicare covered for invasive (implantable) stimulators; Commercial — implantable not medically necessary; semi-invasive not covered

FDA-approved semi-invasive devices identified0 — no FDA-approved semi-invasive devices identified

Medical-Necessity Criteria

Medicare Advantage (implantable/invasive stimulators)

Covered when ALL of the following Medicare NCD conditions are met:

ALL of the following

CMS NCD indication: Indication is nonunion of long bone fractures
Per CMS NCD
Spinal fusion adjunct indication: If related to spinal fusion: 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 (multiple level = 3 or more vertebrae)
Effective July 1, 1996 (CMS NCD)
Nonunion timing: Nonunion is considered to exist only after 6 or more months have elapsed without healing of the fracture

Coding

Covered for Medicare Advantage / Not medically necessary for CommercialmixedCovered

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

Provider Actions

Documentation Required

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.

Minimum of 2 sets of radiographs
Each set must include multiple views of the fracture site
Sets must be separated by at least 90 days

Billing Rule

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.

Background and Evidence Summary

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.

Evidence conclusions and definitions

Overall evidence conclusion (commercial)Insufficient to determine effects on health outcomes

CMS NCD existenceCMS NCD 150.2 provides coverage criteria for invasive stimulators (covers nonunion of long bone fractures; adjunct to spinal fusion in high-risk patients; nonunion defined >=6 months without healing; requires >=2 sets of radiographs separated by >=90 days)

Medicare Determinations

NCD Number	Name	Type	Effective Date
150.2	Osteogenic Stimulators	NCD

Revision History

2023-05-03clarifiedLatest

Policy updated with last review date 05/03/2023; maintains prior coverage positions.