CurrentCentenePolicy CP.MP.194

Osteogenic Stimulation (electrical and ultrasonic) coverage criteria

Defines medical necessity criteria for noninvasive and invasive electrical osteogenesis stimulators and low-intensity pulsed ultrasound (ultrasonic) osteogenesis stimulators, lists not medically necessary indications, coding implications, and background/evidence summary for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyOsteogenic Stimulation (electrical and ultrasonic) coverage criteria

Policy CodePolicy CP.MP.194

Change TypeBackground and references updated; terminology/coding clarified

Effective Date

Next Review Date

Key ActionObtain and retain a minimum of two sets of radiographs, each with multiple views separated by at least 90 days to document cessation of healing prior to starting osteogenic stimulation.

SourceLink

POLICY UPDATE CHANGES

Annual review completed; background and references reviewed and updated (08/23).

Added code E0760 and made annual wording/terminology updates in prior revisions (09/20-09/22 historical entries).

3Therapy types addressed

8Comorbidities increasing nonunion risk

9Not medically necessary LIPUS indications

Coverage Summary

This policy (CP.MP.194) addresses coverage criteria for osteogenic stimulation — both electrical and ultrasonic — for Centene-affiliated health plans and is CURRENT with last review on 2023-08-23.

Scope: defines medical necessity for noninvasive electrical and invasive electrical osteogenesis stimulators as well as low-intensity pulsed ultrasound (LIPUS) devices, lists not medically necessary indications, and provides coding and documentation expectations (e.g., radiographic evidence and timing thresholds).

Coverage stance: mixed — certain indications are covered when specific clinical and radiographic criteria and timing thresholds are met (see policy sections for nonunion, failed fusion, adjunct to spinal fusion, high-risk comorbidities), while other uses are explicitly not medically necessary.

Key policy dates and status: Policy number CP.MP.194, status CURRENT, last review 2023-08-23. Annual reviews noted background and references updates without material changes in the most recent revision.

Therapy types addressed (from brief): noninvasive electrical (PEMF, CC, CMF), invasive electrical, and ultrasonic (LIPUS) osteogenesis stimulators; scope includes criteria for nonunion, failed fusion, adjunct use in spinal fusion, selected fresh fractures for LIPUS, and specified exclusions.

Key Clinical Thresholds

Nonunion radiograph documentation intervalMinimum of two sets of radiographs, each including multiple views, separated by a minimum of 90 days

Nonunion time before noninvasive electrical stimulator>= 90 days since fracture or surgical treatment

Nonunion time before invasive stimulator for spinal fusion failure>= 9 months since last surgery

Nonunion time for failed joint fusion (non-spine)>= 6 months since last surgery

Fracture separationLess than 1 cm (< 1 cm)

Fresh fracture window for LIPUSTreated within seven days post fracture

Coding

Relevant CPT/HCPCS/Device Codes (informational)mixed

20974	Electrical stimulation to aid bone healing; non invasive (nonoperative)
20975	Electrical stimulation to aid bone healing; invasive (operative)
20979	Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative)
A4559	Coupling gel or paste, for use with ultrasound device, per oz.
E0747	Osteogenesis stimulator; electrical, noninvasive, other than spinal applications
E0748	Osteogenesis stimulator; electrical, noninvasive, spinal applications
E0749	Osteogenesis stimulator; electrical, surgically implanted
E0760	Osteogenesis stimulator, low intensity ultrasound, noninvasive

Provider Actions and Requirements

Documentation Required

Radiographic documentation for nonunion

Obtain and retain a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by at least 90 days to document cessation of healing prior to starting osteogenic stimulation.

Documentation Required

Timing verification

Confirm and document time since fracture or last surgery meets policy thresholds before initiating therapy: noninvasive nonunion — at least 90 days since fracture or surgical treatment; failed joint fusion (non-spine) — at least 6 months since last surgery; failed spinal fusion (when specified) — at least 9 months since last surgery. Date-stamp or otherwise record the fracture and/or surgery dates in the medical record.

Prior Authorization

Prior authorization expectation

Prior authorization may be required by the member's health plan. When submitting prior authorization requests, reference the policy’s medical necessity criteria (including the applicable timing, radiographic, anatomic, and comorbidity requirements) to support coverage determinations.

Billing Rule

Code usage guidance

Use the listed CPT/HCPCS codes as appropriate when billing for osteogenic stimulation. Codes include: 20974, 20975, 20979, A4559, E0747, E0748, E0749, E0760. Verify and reference current professional coding guidance prior to claim submission.

20974
20975
20979
A4559
E0747
E0748
E0749
E0760

Background and Evidence Summary

Background: Osteogenic stimulators are available as invasive (implantable/direct current delivered via electrodes) and noninvasive devices. Noninvasive electrical devices deliver current via capacitive coupling (CC), pulsed electromagnetic field (PEMF), or combined magnetic field (CMF) coils placed externally; ultrasonic stimulators deliver low-intensity pulsed ultrasound (LIPUS) through the skin using coupling gel.

Mechanisms and evidence: LIPUS transmits acoustic pressure waves producing micromechanical stresses that induce biochemical changes to promote bone formation and has demonstrated benefit when used as an adjunct to stabilization for selected fresh fractures and for nonunions, with reported chronic nonunion healing rates in some series ranging from 84% to 100%. Electrical stimulation (PEMF/CMF/CC) has shown effectiveness for long-bone nonunions and as an adjunct to spinal fusion in some studies, but observed effectiveness varies widely (reported 32.8% to 97.4% in an FDA literature review) likely due to differences in device, waveform, anatomic site, and study methodology.

Evidence limitations and research needs: Strength of evidence varies across fracture types and device modalities; while some randomized and observational studies report meaningful fusion/healing rates, the policy notes that better-designed clinical studies are needed to define optimal applications and confirm efficacy across indications.

Regulatory/authority summary: An FDA literature review confirmed expected benefits for PEMF and CMF devices but noted wide variation in reported effectiveness attributable to heterogeneity in methods and populations; implantable electrical stimulators are FDA-approved for long-bone nonunion and adjunctive use in high-risk spinal fusion situations.

Evidence Highlights

PEMF/CMF effectiveness range32.8% to 97.4% (variation due to methodology, device, anatomy, waveform, frequency, population)

PEMF tibia single-arm study fusion rate77.3% fusion in tibia (single-arm prospective study)

Randomized studies PEMF vs control fusion rates83.6% treatment vs 68.6% control (reported randomized trials)

LIPUS chronic nonunion healing ratesReported overall healing rates 84% to 100%

LIPUS referenced cohort noteCohort study of 767 patients reported heal rate for chronic (>1 year) nonunion

Definitions

Multilevel spinal fusion: defined in the policy as involving three or more vertebrae.

Nonunion radiograph documentation: requires a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by at least 90 days to document that healing has ceased prior to initiating osteogenic stimulation.

Determination	Effective Date / ID
NCD 150.2 Osteogenic stimulators	2005-04-27 / NCD 150.2

Policy Summary

PayerCentene

PolicyOsteogenic Stimulation (electrical and ultrasonic) coverage criteria

Policy CodePolicy CP.MP.194

Change TypeBackground and references updated; terminology/coding clarified

Effective Date

Next Review Date

Key ActionObtain and retain a minimum of two sets of radiographs, each with multiple views separated by at least 90 days to document cessation of healing prior to starting osteogenic stimulation.

SourceLink

On This Page

OpenPayer

Osteogenic Stimulation (electrical and ultrasonic) coverage criteria

Coverage Summary

Noninvasive Electrical Osteogenesis Stimulators — Medically Necessary

Invasive Electrical Osteogenesis Stimulators — Medically Necessary

Ultrasonic (LIPUS) Osteogenesis Stimulators — Medically Necessary

Ultrasonic Osteogenesis Stimulators — Not Medically Necessary

General Not Medically Necessary

Coding

Provider Actions and Requirements

Background and Evidence Summary

Definitions

Medicare Determinations

Revision History