CurrentWellCarePolicy CP.MP.194

Clinical Policy: Osteogenic Stimulation

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Medical necessity criteria for electrical (invasive and noninvasive) and ultrasonic (LIPUS) osteogenic stimulators to enhance bone healing; governs coverage decisions for WellCare/Centene-affiliated health plans and affects providers requesting these devices.

Policy Summary

PayerWellCare

PolicyClinical Policy: Osteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material changes noted

Effective Date

Next Review Date

Key ActionObtain prior authorization with supporting documentation (serial radiographs, fracture age, infection status, stability and relevant comorbidities) before requesting osteogenic stimulators.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daysfracture age threshold

6 monthsfailed fusion (non-spine)

9 monthsfailed spinal fusion

3+ vertebraemultilevel fusion

20 min/day

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CurrentWellCarePolicy CP.MP.194

Clinical Policy: Osteogenic Stimulation

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Policy Summary

PayerWellCare

PolicyClinical Policy: Osteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material changes noted

Effective Date

Next Review Date

Key ActionObtain prior authorization with supporting documentation (serial radiographs, fracture age, infection status, stability and relevant comorbidities) before requesting osteogenic stimulators.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 daysfracture age threshold

6 monthsfailed fusion (non-spine)

9 monthsfailed spinal fusion

3+ vertebraemultilevel fusion

20 min/day

Multiple reviewsrevision mentions

Medical Necessity and Coverage Criteria

Noninvasive electrical osteogenesis stimulators — medically necessary

Covered when ANY of the following apply

Nonunion of long bone fracture and 90-day requirement: A. Nonunion of long bone fracture (clavicle, humerus, radius, ulna, femur, tibia, fibula, phalanges, metacarpal or metatarsal) and at least 90 days have passed since the date of fracture or the date of surgical treatment of the fracture and ALL of: (1) the bone is not infected; (2) the two portions of the bone involved in the nonunion are separated by less than 1 centimeter (cm); (3) the bone is stable at both ends by means of a cast or fixation; (4) serial radiographs have confirmed that fracture healing has ceased for three or more months prior to starting treatment. Serial radiographs must include a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.>= 90 days

Includes listed long bones: clavicle, humerus, radius, ulna, femur, tibia, fibula, phalanges, metacarpal, metatarsal

Failed fusion (non-spine): B. Failed fusion of a joint, other than the spine, in which a minimum of six months has elapsed since the last surgery.6 months

Congenital pseudoarthrosis: C. Congenital pseudoarthrosis.

Adjunct to spinal fusion: D. As an adjunct to spinal fusion surgery for patients at high risk of pseudoarthrosis due to previously failed fusion surgery or for those undergoing a multilevel spinal fusion (involving three or more vertebrae).>= 3 vertebrae

Risk factors for delayed/non-union: E. Risk of delayed or non-union of fractures due to conditions or comorbidities (examples include: alcoholism; chemotherapy; diabetes; obesity; osteoporosis; renal disease; tobacco use; steroid use).

List not all-inclusive

Invasive electrical osteogenesis stimulators — medically necessary

Covered when ANY of the following apply

Nonunion of long bone fracture: A. Nonunion of long bone fracture and ALL of: (1) the bone is not infected; (2) the two portions of the bone involved in the nonunion are separated by less than one cm; (3) the bone is stable at both ends by means of a cast or fixation; (4) serial radiographs have confirmed that fracture healing has ceased for three or more months prior to starting treatment with the invasive bone growth stimulator. Serial radiographs must include a minimum of two sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.

Failed spinal fusion: B. Failed spinal fusion in which a minimum of nine months has elapsed since the last surgery and/or as an adjunct to spinal fusion surgery for patients at high risk of pseudoarthrosis.9 months

Multilevel spinal fusion: C. Following a multilevel spinal fusion (involving three or more vertebrae).>= 3 vertebrae

Ultrasonic (LIPUS) osteogenesis stimulators — medically necessary

Covered when ANY of the following apply

Adjunct for fresh fractures: A. Used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures when there is high risk for delayed fracture healing or nonunion AND at least one of the specified risk factors/indications is present.Fresh = <= 7 days for specified indications

Specific eligible fresh fracture locations/conditions listed in subsequent nodes

Eligible fresh fracture indications: 1. Fracture associated with extensive soft tissue or vascular damage; 2. Fresh (seven days or less in duration), closed or grade I open, short oblique or short spiral tibial diaphyseal fractures treated with closed reduction and cast immobilization in skeletally mature patients; 3. Fresh, closed distal radius (Colles') fractures treated with closed reduction and cast immobilization in skeletally mature patients; 4. Fresh Jones fracture (5th metatarsal); 5. Fresh fractures of the scaphoid.<= 7 days

Nonunion indications:

Policy criteria (referenced; full text not in provided chunks)

Policy contains multiple criteria sections with revisions over time; specific coverage criteria (I, II, III) are referenced in the revision history but full criteria text is not present in these chunks.

policy revisions mention: Revisions added or modified criteria such as definition of multilevel fusion (involving three or more vertebrae), replacement of 'smoking habit' with 'tobacco use', addition of code E0760, removal of duplicative criteria (e.g., II.D.), and other minor wording updates noted in the revision history.

Full structured criteria (e.g., lists of required clinical conditions) are not included in these chunks.

Ultrasonic (LIPUS) osteogenesis stimulators are not medically necessary when used in combination with other noninvasive osteogenic stimulators. The policy explicitly lists additional non-covered indications including avascular necrosis of the femoral head, stress fractures, fractures with a gap greater than 1 cm, fresh fractures in locations other than the distal radius, tibial diaphysis, 5th metatarsal (Jones fracture) or scaphoid, fresh tibial diaphyseal or tibial and fibular fractures treated with closed reduction and intramedullary nailing when no risk factors for poor healing are present, preoperative use for fractures that require surgical intervention or fixation, and tibial stress fractures.

Osteogenic stimulation devices are designated not medically necessary for nonunion fractures of the skull and vertebrae, and for fractures that are tumor-related (malignancy-related). Claims for these nonunion indications may be denied under the policy.

The policy revision history documents removal and modification of prior language and criteria (for example, removal of specific parenthetical qualifiers and replacement of terms such as 'fusion at more than one level' with 'multilevel fusion'). These revisions are summarized in the revision log; the full prior wording is not reproduced here.

Use of ultrasonic stimulators for the indications enumerated in the exclusions (see list of noncovered uses above) is explicitly not supported. The policy also specifies that use of ultrasonic devices in the preoperative period for fractures that require surgical intervention or fixation is not medically necessary.

Codes referenced in this clinical policy are provided for informational purposes only and inclusion or exclusion of any codes does not guarantee coverage. Providers must confirm coverage and any authorization requirements using current coding guidance before submitting claims.

Coding References and Key Parameters

Coding referencesmixed

CPT referenced

CPT codes referenced in this clinical policy are for informational purposes only; specific codes listed in policy text (if any) should be used for billing.

Referenced CPT CodesCPT

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).

Referenced HCPCS CodesHCPCS

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.

Radiograph separation — minimum 90 days between radiograph sets

RequirementSerial radiographs must include a minimum of two sets separated by a minimum of 90 days.

PurposeTo document cessation of fracture healing for ≥3 months prior to initiating osteogenic stimulation.

Applies toNoninvasive and invasive osteogenic stimulator coverage criteria for nonunion indications requiring radiographic proof of halted healing.

Nonunion fracture age for noninvasive stimulation — >= 90 days since fracture or surgery

Threshold>= 90 days since date of fracture or date of surgical treatment

Applies to

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Obtain prior authorization with required clinical documentation

Prior authorization is required before coverage of osteogenic stimulators. Requests must include documentation satisfying the medical necessity criteria (e.g., fracture age or time since surgery, infection status, stability, and serial radiographs) as described in the policy.

Provide evidence of fracture or surgical date (e.g., >=90 days for nonunion noninvasive stimulation; >=9 months for failed spinal fusion with invasive stimulation).
Document infection status, stability at both ends (cast or fixation), and fracture gap (<1 cm where required).
Include serial radiographs showing cessation of healing for >=3 months (minimum two sets separated by >=90 days).

Note

Confirm coverage and prior authorization for referenced codes

Verify coverage and any prior authorization rules for the specific CPT/HCPCS codes before submitting claims; consult current professional coding guidance and payer requirements.

Clinical Background and Rationale

Fracture healing may be impaired by clinical factors that increase the risk of delayed union or nonunion. Contributing factors include insufficient blood supply, inadequate immobilization, a fracture gap >= 1 cm (policy uses <1 cm as an eligibility requirement), infection of the bone, extensive soft-tissue or vascular damage, and comorbid conditions such as alcoholism, chemotherapy, diabetes, obesity, osteoporosis, renal disease, tobacco use, and steroid use.

Device and Term Definitions

Noninvasive electrical osteogenic stimulator — device delivering electrical current via external coils (CC, PEMF, etc.)

DefinitionDevice delivering electrical current to the fracture site via external treatment coils using capacitive coupling (CC), pulsed electromagnetic field (PEMF), or combined magnetic field technology (CMFT).

DeliveryNoninvasive: external coils placed around the fracture with external power supply.

Typical indicationsNonunion of long bones, failed fusion (non-spine), adjunct to spinal fusion in select patients per policy criteria.

Ultrasonic (LIPUS) osteogenic stimulator — noninvasive device emitting low-intensity pulsed ultrasound, typical home use ~20 min/day

DefinitionNoninvasive device that emits low-intensity pulsed ultrasound (LIPUS) applied to the skin over the fracture site using coupling gel.

Typical home use

Document Revision History

2008-08-11approval

Original approval of the clinical policy (original approval date listed as 8/11).

2019-11-19approval

Approved by the Medical Policy Committee with no changes noted at that approval date.

2020-09revision

Policy transferred to CNC template, renamed from HS-019, 'members' changed to 'members/enrollees', and multiple criteria edits including removal of '(non-spinal electrical osteogenesis stimulators)' from policy statement I and updates to criteria I.C. to 'multilevel fusion.'

Policy Summary

PayerWellCare

PolicyClinical Policy: Osteogenic Stimulation

Policy CodePolicy CP.MP.194

Change TypeNo material changes noted

Effective Date

Next Review Date

Key ActionObtain prior authorization with supporting documentation (serial radiographs, fracture age, infection status, stability and relevant comorbidities) before requesting osteogenic stimulators.

SourceLink

On This Page

Previously failed fusion at same site: D. Following spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site.

List not all-inclusive

6. Nonunion of bones other than the skull or vertebrae in skeletally mature patients, excluding those related to malignancy, when both: (a) documented by a minimum of two sets of radiographs obtained prior to starting treatment, separated by a minimum of 90 days; and (b) the two portions of the bone involved in the nonunion are separated by less than one cm.

radiographs >=90 days apart; gap <1 cm

Risk factors for fresh fractures: B. Risk of delayed or nonunion of any fresh, closed fractures due to conditions or comorbidities (examples include: alcoholism; chemotherapy; diabetes; obesity; osteoporosis; renal disease; tobacco use; steroid use).

List not all-inclusive

Nonunion of long bone fractures for noninvasive electrical osteogenesis stimulators.

Additional requirementsBone not infected; gap < 1 cm; bone stable at both ends by cast or fixation; serial radiographs demonstrate healing ceased for ≥3 months.

Failed spinal fusion interval for invasive stimulation — >= 9 months since last surgery

Threshold>= 9 months elapsed since last surgery

Applies toFailed spinal fusion indication for invasive (implantable) electrical osteogenesis stimulators.

Alternate useAlso used as adjunct to spinal fusion for patients at high risk of pseudoarthrosis.

LIPUS at-home usage — 20 minutes once daily

Home-use regimen20 minutes once daily until healing occurs.

IndicationUsed as adjunct to stabilization for selected fresh fractures and as secondary therapy for nonunions.

ApplicationApplied to skin over fracture site with coupling gel; patient-administered device prescribed by a physician.

Codes referenced in the policy (e.g., 20974, 20975, 20979, A4559, E0747, E0748, E0749, E0760) are informational — confirm plan-specific coverage.
Reference the most up-to-date coding manuals/guidance prior to claim submission.

Note

Use LIPUS only as an adjunct to conventional management

Ultrasonic (LIPUS) therapy is intended to be used adjunctively with conventional fracture stabilization (closed reduction and cast immobilization) for specified fresh fractures or as secondary therapy for nonunions.

LIPUS is prescribed for at-home use (typically 20 minutes once daily) and must be used in conjunction with stabilization measures.
Eligible fresh fracture locations and criteria are specified in the policy (e.g., select tibial diaphyseal, distal radius, 5th metatarsal Jones fracture, scaphoid).

Step Therapy

Refer to full policy criteria for therapy sequencing

Consult the full policy criteria sections for any step therapy or sequencing requirements — the revision history and criteria updates may affect sequencing and applicability.

Policy revision history notes changes (e.g., multilevel fusion definition, added/removed criteria) — review criteria text for sequencing details.
Not all step-therapy details are included in the summary chunks; refer to the complete policy for definitive sequencing guidance.

Documentation Required

Submit serial radiographs separated by >=90 days

Include serial radiographic documentation showing that fracture healing has ceased for >=3 months: provide a minimum of two radiograph sets, each with multiple views of the fracture site, separated by at least 90 days prior to starting stimulation therapy.

Minimum requirement: two sets of radiographs obtained prior to treatment, each including multiple views and separated by >=90 days.
Radiographs must demonstrate cessation of healing for three or more months when required by the criteria.

Documentation Required

Provide required clinical condition documentation

Document clinical findings required by the policy: confirm bone is not infected, fracture gap is less than 1 cm, and the bone is stable at both ends (by cast or fixation) for nonunion indications.

Explicitly record infection status and measured fracture gap (<1 cm where specified).
Document stability at both ends by description of casting or fixation.

Billing Rule

Follow current professional coding guidance prior to billing

Before claim submission, reference the most current professional coding guidance and payer-specific instructions to ensure appropriate code selection and billing.

Policy notes that CPT/HCPCS codes shown are informational and that providers should use current coding manuals.
Confirm code applicability for invasive vs noninvasive devices (e.g., 20974 vs 20975; E0747–E0749; E0760).

Denial Risk

Denial risk if LIPUS used for non-covered indications

Using ultrasonic stimulators for indications listed as not medically necessary (such as concurrent use with other noninvasive stimulators, avascular necrosis, stress fractures, fractures with gap >1 cm, or certain fresh fractures) may result in claim denial.

Preoperative use for fractures requiring surgical fixation and tibial stress fractures are specifically listed as not medically necessary and subject to denial.
Concurrent use with other noninvasive osteogenic stimulators is explicitly not medically necessary.

Denial Risk

Do not use devices for skull, vertebrae, or tumor-related nonunions

Osteogenic devices are not medically necessary for nonunions of the skull, vertebrae, or tumor-related (malignancy-related) fractures; use for these indications may be denied.

Policy explicitly states osteogenic devices are not medically necessary for skull or vertebral nonunions and tumor-related fractures.
Do not submit authorization requests for these excluded nonunion sites.

Note

Coding inclusion does not guarantee coverage — verify before billing

Inclusion of a CPT or HCPCS code in this policy is informational and does not guarantee coverage; providers must verify current coverage and coding rules with the plan before submitting claims.

The policy states that codes referenced are for informational purposes only and that inclusion/exclusion does not guarantee coverage.
Always confirm plan-specific coverage for codes such as 20974, 20975, 20979, A4559, E0747–E0749, and E0760.

Patient uses the prescribed device at home for approximately 20 minutes once daily until healing occurs.

RoleAdjunct to conventional management for selected fresh fractures and as secondary therapy for nonunions per policy criteria.

Invasive (implantable) electrical stimulator — direct current via implanted electrodes or percutaneous cathodes/coils

DefinitionDevice delivering direct current to the fracture or fusion site via implanted electrodes or percutaneously placed cathodes/coiled cathode wires.

Delivery methodInvasive/implantable systems: electrodes or coiled cathode wires placed at the target site to provide electrical stimulation.

IndicationsUsed for nonunion of long bones and failed spinal fusion per policy-specified criteria.

Multilevel spinal fusion definition — defined in policy revision history as involving three or more vertebrae

DefinitionMultilevel spinal fusion is defined in the policy revision history as involving three or more vertebrae.

Policy contextThis definition was added to criteria points related to adjunctive use for spinal fusion (I.D. and II.C.).

Use implicationAdjunctive osteogenic stimulation may be considered for multilevel fusions (>=3 vertebrae) per coverage criteria.

2021-09revision

Annual review: wording changes including definition of multilevel spinal fusion (three or more vertebrae) added to criteria I.D. and II.C., removal of duplicative criteria point II.D., addition of code E0760, and header label changes for review/revision dates.

2023-08reviewLatest

Annual review completed; background and references reviewed and updated, and wording edits such as replacing 'smoking habit' with 'tobacco use' were applied across criteria sections.