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Osteogenic Stimulators (non-invasive, invasive/semi-invasive, electrical and ultrasound)
05.00.81
​

Policy

MEDICALLY NECESSARY
 
NON-INVASIVE ELECTRICAL BONE GROWTH STIMULATORS OF THE APPENDICULAR SKELETON


Nonunion Fractures and Congenital Pseudarthroses of the Appendicular Skeleton
 
Noninvasive electrical bone growth stimulators are considered medically necessary and, therefore, covered for the treatment of nonunion fractures (including nonunion of previously surgically treated fractures, nonunion of sesamoid fractures, nonunion of stress fractures), or congenital pseudarthroses (i.e., a spontaneous fracture that progresses to nonunion) of the appendicular skeleton (i.e., bones of the shoulder girdle, bones of the upper and lower extremities, and the pelvic girdle) when ALL of the following criteria are met:

  • Skeletal system is determined to be mature (e.g., as evidenced by hand-wrist radiographs)
  • At least 3 months have passed since original fracture date
  • Serial radiographs confirm that no progression in healing has taken place
  • The fracture gap is 1 centimeter (cm) or less
  • ​The fracture can be adequately immobilized and a non-weight-bearing status is maintained as appropriate.
F​ailed Surgical Fusion of Joints of the Appendicular Skeleton

Noninvasive electrical bone growth stimulators are considered medically necessary and, therefore, covered as treatment for failed surgical fusion of joints of the appendicular skeleton (e.g. wrist, ankle, toe, shoulder, elbow, hip), as defined by a surgical fusion that has not healed for a minimum of 6 months following the last surgery, as evidenced by serial radiographs over a course of 3 months.

INVASIVE ELECTRICAL BONE GROWTH STIMULATORS OF THE LUMBAR SPINE

Invasive electrical bone growth stimulators are considered medically necessary and, therefore, covered as an adjunct to lumbar spinal fusion for individuals at high risk for fusion failure, when one of the following criteria is met:

  • Grade III or worse spondylolisthesis
  • One or more previous failed spinal fusion(s)
  • Fusion to be performed at more than one level
  • Individual has one or more of the following comorbidities:
    • Diagnosis of alcoholism
    • Current tobacco use
    • Diagnosis of diabetes
    • Current use of prescribed steroids
    • Diagnosis of osteoporosis
    • Diagnosis of renal disease
    • Current use of prescribed anticoagulation medications

LOW-INTENSITY ULTRASOUND ACCELERATED FRACTURE HEALING SYSTEM OF THE APPENDICULAR SKELETON

Fresh, Closed Fractures of the Appendicular Skeleton at Risk for Becoming Delayed or Nonunion Fractures


Low-intensity ultrasound accelerated fracture healing systems are considered medically necessary and, therefore, covered as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures of the appendicular skeletal system (i.e., bones of the shoulder girdle, bones of the upper and lower extremities, and bones of the pelvis) that is determined to be mature (e.g., evidenced by hand-wrist radiographs), and is determined to be at high risk for delayed fracture healing or nonunion fractures, which includes having at least ONE of the following indications (i.e., one comorbidity OR one fracture location):   

  • The individual has one of the following comorbidities:
    • Diagnosis of alcoholism
    • Current tobacco use
    • Diagnosis of diabetes
    • Current use of prescribed steroids
    • Diagnosis of osteoporosis
    • Diagnosis of renal disease
    • Current use of prescribed anticoagulation medication
OR

  • The individual has one of the following fracture locations:
    • Fracture of metatarsal, including Jones fracture (5th metatarsal)
    • Navicular bone fracture of the wrist (also known as the scaphoid)
    • Fractures associated with extensive soft tissue or vascular damage​

Delayed Union Fractures of the Appendicular Skeleton
 
Low-intensity ultrasound accelerated fracture healing systems are considered medically necessary and, therefore, covered as a treatment of delayed union fractures (including delayed union of previously surgically treated fractures, delayed union of sesamoid fractures, delayed union of stress fractures) of the appendicular skeleton (i.e., bones of the shoulder girdle, bones of the upper and lower extremities, and the pelvic girdle) that is determined to be mature (e.g., evidenced by hand-wrist radiographs), when ALL of the following criteria are met:

  • At least 3 months have passed since the index injury or the most recent intervention.
  • The decelerating healing process is confirmed by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site​

Nonunion Fractures of the Appendicular Skeleton
 
Low-intensity ultrasound accelerated fracture healing systems are considered medically necessary and, therefore, covered as a treatment of established nonunion fractures (including nonunion of previously surgically treated fractures), nonunion of sesamoid fractures, nonunion of stress fractures, of the appendicular skeleton (i.e., bones of the shoulder girdle, bones of the upper and lower extremities, and the pelvic girdle), when ALL of the following criteria are met:

  • Skeletal system is determined to be mature (e.g., evidenced by hand-wrist radiographs)
  • At least 3 months have passed since the original fracture date
  • Serial radiographs confirm that no progression in healing has taken place
  • The fracture gap is 1 cm or less
  • The fracture can be adequately immobilized, and a non-weight-bearing status is maintained as appropriate

EXPERIMENTAL/INVESTIGATIONAL
 
All other uses for noninvasive electrical bone growth stimulators of the appendicular skeleton are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature. This includes, but is not limited to, the following:

  • Treatment of fresh fractures
  • Treatment of delayed union fractures
  • Postsurgical treatment after appendicular skeletal surgery without evidence of nonunion
  • Treatment of sesamoid fractures without evidence of nonunion
  • Treatment of stress fractures without evidence of nonunion
  • Treatment of patellar tendinopathy
Invasive and semi-invasive electrical bone growth stimulators of the appendicular skeleton are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.​

Semi-invasive electrical stimulation as an adjunct to lumbar fusion surgery and for failed lumbar fusion is considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.


Invasive and semi-invasive electrical stimulation as an adjunct to cervical or thoracic fusion surgery and for failed cervical or thoracic spine fusion is considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.


All other uses for low-intensity ultrasound accelerated fracture healing systems, including but not limited to the following, are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.


  • Treatment of open fractures
  • Treatment of fractures treated with an open procedure (i.e., ORIF) without evidence of delayed union or nonunion
  • Treatment of fresh surgically treated closed fractures
  • Treatment of sesamoid fractures without evidence of delayed union or nonunion
  • Treatment of stress fractures without evidence of delayed union or nonunion
  • Treatment of fractures of the skull or vertebrae
  • Treatment of fractures that are tumor-related
  • For concurrent use with another noninvasive osteogenic stimulator
  • Treatment in a skeletal system determined not to be mature (e.g., evidenced by hand-wrist radiographs)
  • Treatment of a spinal fusion
  • Treatment of congenital pseudarthroses
  • Treatment of an arthrodesis or failed arthrodesis
  • Treatment of patellar tendinopathies

Guidelines

REQUIRED DOCUMENTATION
 
The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:


STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.
 
PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member's receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.


CONSUMABLE SUPPLIES
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual's medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply. If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.​


BENEFIT APPLICATION
 
Subject to the terms and conditions of the applicable benefit contract, bone growth stimulators are covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.


Services that are experimental/investigational are benefit contract exclusions for all products of the Company.
 

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
 
There are numerous devices approved by the FDA for bone growth stimulation.

Description

Serial radiographs are defined as at least two sets of appropriate imaging studies separated by a minimum of 90 days or 3 months, confirming that clinically significant fracture healing has not occurred.


Manufacturer labeling may vary regarding the programming and the operational time frame of the stimulator.


TYPES OF FRACTURES
 
FRESH FRACTURES
A fresh fracture is commonly defined as “fresh" for around the first 7 days from when the fracture occurred. Most fresh closed fractures heal without complications with the use of standard fracture care, i.e., closed reduction and cast immobilization.


DELAYED UNION FRACTURES

A delayed union fracture can be defined as a decelerating healing process of the bone. It is determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for at least 3 months from the initial fracture or the most recent intervention, in which healing has not advanced at the average rate for the location and type of fracture. 


NONUNION FRACTURES
A nonunion fracture is considered established when the fracture site shows no visibly progressive signs of healing, for at least 3 consecutive months from the time of the fracture.
 
STAGES OF NORMAL BONE HEALING
 
Fractured bones go through a natural healing process that includes the growth of both bone mass and bone density. Normal bone healing usually occurs in three stages: 

  • Inflammatory stage: in this stage, a hematoma forms on the fracture site after the injury. Inflammatory cells infiltrate the bone to form granulation tissue, vascular tissue, and immature tissue. This process will continue for 2 to 4 weeks.
  • Reparative stage: in this stage, the healing process takes place. The various components needed to build new bone and fill the fracture gap come together to form the "fracture callous." The callous is then replaced with lamellar bone (hard, rigid, connective tissue). The lamellar bone is mineralized, causing it to become harder and stronger. The result is called trabecular bone (spongy osseous material), which is vascularized. This process takes from 1 to 2 months.
  • Remodeling stage: this stage brings about the change of the trabecular bone to a denser, more mature bone. This phase may take up to 5 years to be completed and is dependent upon the type of bone fractured and the age and health status of the individual.

In approximately 5% to 10% of fractured bones, healing is impaired or does not progress at a normal rate. This impaired progression results in continued morbidity by causing the fracture to be at risk for nonunion or delayed union. Delayed union occurs when there is a deceleration in the fracture healing process (as identified by serial radiographic documentation). Nonunion fracture is defined as the point at which healing has stopped, and further healing has ceased for 3 or more months (as evidenced by serial radiographic documentation). Delayed union differs from nonunion in that, in the former, there are no indications that the union will fail, while in the latter, there are no visible signs that union will occur (i.e., serial radiographic documentation shows no evidence of healing). Moreover, any fracture type, such as a previously surgically treated fracture, a sesamoid fracture, or a stress fracture (i.e., small crack in the bone), can develop into a delayed union or nonunion.


Most, if not all, nonunion fractures require some type of intervention to heal. In some cases, a bone growth stimulator (osteogenesis stimulator) may be used to encourage or reactivate the healing process by physical methods including electrical and low-intensity pulsed ultrasound. Electrical bone growth stimulators provide stimulation through electrodes placed either at or around the fracture site. Studies support the theory that these electrodes produce electromagnetic fields that trigger a small electrical current similar to the signals that the body naturally produces to initiate bone healing. Low-intensity ultrasound accelerated fracture healing system delivered via a special device placed in contact with the skin overlying the fracture site delivers low-intensity pulsed ultrasound waves with the aim of stimulating bone healing. It is proposed that healing is promoted by stimulating the production of growth factors and proteins that include the removal of old bone, increase the production of new bone, and increase the rate at which fibrous matrix at a fracture site is converted to mineralized bone. Studies are ongoing regarding the nature of bone osteogenesis and the application of techniques for applying electrical and low-intensity pulsed ultrasonic fields to promote healing at fracture sites.


ELECTRICAL BONE GROWTH STIMULATORS
 
INDICATIONS FOR USE OF ELECTRICAL BONE GROWTH STIMULATORS

Electrical bone growth stimulators have been approved by the US Food and Drug Administration (FDA) for treatment of the following:

  • Nonunion fractures of the appendicular skeleton: fractures with no visible signs of healing (e.g., cortical and/or trabecular bridging with major modifications of the radiolucent gap) for at least 3 consecutive months
  • Congenital pseudarthrosis of the appendicular skeleton: congenital disorder of the diaphysis, which is revealed by a pseudarthrosis or "false joint" due to the inability to form a normal callus to bridge the gap following a fracture, and also manifests in bone with modifications such as bowing, narrowing of the medullary canal, or a cyst.
  • Failed surgical fusion: unsuccessful fusion, as defined by a surgical fusion that has not healed for a minimum of 6 months following the original surgery, which may be evidenced by a decrease in cortical and/or trabecular bridging, presence of angulation (motion), or a radiolucent gap.

APPLICATION METHODS FOR ELECTRICAL BONE GROWTH STIMULATORS

  • Noninvasive: Noninvasive devices may use pulsed electromagnetic fields (PEMFs) that rely on inductive coupling, capacitive coupling, or combined magnetic fields technology to generate the current. An external power supply and externally applied coils or a transducer are placed on skin overlying the fracture and generate a weak electrical current through the site where bone growth is desired. The size of the electric field is dependent on the scale of the magnetic field and the physical qualities of the tissues immediately surrounding the fracture site.
  • Invasive: A technique that uses a direct electrical current, with a current generator surgically implanted in an intramuscular or subcutaneous space. The generator is connected to an electrode that is surgically implanted within the bone fragments that need to be fused. The implanted device typically remains functional for 6 to 9 months after implantation. Although the generator is surgically removed when the course of treatment is complete, the electrode may or may not be removed.
  • Semi-invasive: A direct current is delivered via electrodes percutaneously placed in the proximity of the site to receive treatment, and the generator is placed on the external surface of the body. Currently, semi-invasive electrical bone growth stimulators are not approved by the FDA.​

LOW-INTENSITY ULTRASOUND ACCELERATED FRACTURE HEALING SYSTEM
 
USES OF LOW-INTENSITY ULTRASOUND ACCELERATED FRACTURE HEALING SYSTEM

Low-intensity ultrasound accelerated fracture healing systems received approval from the FDA as an adjunct treatment to closed reduction and cast immobilization in a skeletal system that has been determined to be mature for the following fracture types:

  • Fresh, closed, posteriorly displaced distal radius fractures (Colles fractures)
  • Fresh, closed or Grade I open tibial diaphysis fractures
Fresh fractures are most commonly defined as the first 7 days from the initial fracture. In addition, a Grade I open tibial diaphysis fracture is associated with skin breakage or opening of 1 centimeter (cm) or less. In clinical trials, the use of a low-intensity ultrasonic bone growth stimulator for treatment of fresh fractures of the tibial diaphysis and distal radius demonstrated significantly faster healing times than fractures that were not treated with the system. Fractures of the tibial diaphysis and distal radius are typically associated with a high risk for nonunion.​

The FDA has expanded its original approval of low-intensity ultrasound accelerated fracture healing systems to include the treatment of the following fracture types of the appendicular skeleton (i.e., bones of the shoulder girdle, bones of the upper and lower extremities, and bones of the pelvis, excluding the skull and vertebrae):

  • Established nonunion fractures
  • Delayed union fractures 

The safety and effectiveness of low-intensity ultrasound accelerated fracture healing systems have not been established in a skeletal system that is not mature, or in nonunion fractures of the skull and vertebrae.


APPLICATION METHOD FOR LOW-INTENSITY ULTRASOUND ACCELERATED FRACTURE HEALING SYSTEMS

  • Noninvasive: Low-intensity ultrasound accelerated fracture healing systems are applied noninvasively to the external surface of the affected body part, over the area to receive the treatment. The exact mechanism of healing is unknown, but it is believed that the ultrasound causes biochemical changes at the cellular level, accelerating bone growth.

References

Agency for Healthcare Research and Quality. Technology Assessment. The role of bone growth stimulating devices and orthobiologics in healing nonunion fractures. [Centers for Medicare & Medicaid Services (CMS) Web site]. 09/21/05. Available at: https://www.cms.gov/medicare-coverage-database/view/technology-assessments.aspx?TAId=29. Accessed June 27, 2022.


Ahl T, Andersson G, Herberts P, Kalen R. Electrical treatment of non-united fractures. Acta Orthop Scand. 1984;55(6):585-8.


Aleem IS, Aleem I, Evaniew N, et al. Efficacy of electrical stimulators for bone healing: a meta-analysis of randomized sham-controlled trials. Sci Rep. 2016;6:31724.


Barker AT, Dixon RA, Sharrard WJ, et al. Pulsed magnetic field therapy for tibial non-union. Interim results of a double-blind trial. Lancet. 1984;1(8384):994-6.


Beck BR, Matheson GO, Bergman G, et al. Do capacitively coupled electric fields accelerate tibial stress fracture healing? A randomized controlled trial. Am J Sports Med. 2008;36(3):545-53. 


Bhandari M, Fong K, Sprague S, et al. Variability in the definition and perceived causes of delayed unions and nonunions: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am. 2012;94(15):e1091-6. 


Borsalino G, Bagnacani M, Bettati E, et al. Electrical stimulation of human femoral intertrochanteric osteotomies. Double-blind study. Clin Orthop Relat Res. 1988;237:256-63.


Busse JW, Bhandari M, Kulkami AV, et al. The effect of low-intensity pulsed ultrasound therapy on time to fracture healing a meta-analysis. CMAJ. 2002;166:(4):437-441.


Busse JW, Kaur J, Mollon B, et al. Low intensity pulsed ultrasonography for fractures: systematic review of randomised controlled trials. BMJ. 2009;338:b351.


Buza JA 3rd, Einhorn T. Bone healing in 2016. Clin Cases Miner Bone Metab. 2016;13(2):101-5. 


Centers for Medicare & Medicaid Services. National Coverage Determination (NCD): Osteogenic Stimulators (150.2). Available at:  https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=65&ncdver=2&bc=0. Accessed June 27, 2022.


Connolly JF. Electrical treatment of nonunions. Its use and abuse in 100 consecutive fractures. Orthop Clin North Am. 1984;15(1):89-106.


Connolly JF. Selection, evaluation and indications for electrical stimulation of ununited fractures. Clin Orthop. 1981;161:39-53.


de Haas WG, Beaupre A, Cameron H, English E. The Canadian experience with pulsed magnetic fields in the treatment of ununited tibial fractures. Clin Orthop Relat Res. 1986;208:55-8.


Dhawan SK, Conti SF, Towers J, et al. The effect of pulsed electromagnetic fields on hindfoot arthrodesis: a prospective study. J Foot Ankle Surg. 2004;43(2):93-6.


Emami A, Petren-Mallmin M, Larsson S. No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. J Orthrop Trauma. 1999;13(4):252-7.


Faldini C, Cadossi M, Luciani D, et al. Electromagnetic bone growth stimulation in patients with femoral neck fractures treated with screws: prospective randomized double-blind study. Curr Orthop Pract. 2010;21(3):282-7. 


Gaston, MS, Simpson AH.  Inhibition of fracture healing. J Bone Joint Surg Br. 2007;89(12):1553-60.


Griffin XL, Costa ML, Parsons N, et al. Electromagnetic field stimulation for treating delayed union or non-union of long bone fractures in adults. Cochrane Database Syst Rev. 2011;4:CD008471.


Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: what is the evidence? Injury. 2008;39(4):419-29.


Hannemann PFW, Essers BAB, Schots JPM, et al. Functional outcome and cost-effectiveness of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a cost-utility analysis. BMC Musculoskelet Disord. 2015;16:84.


Hannemann PFW, Gottgens KWA, van Wely BJ, et al. The clinical and radiological outcome of pulsed electromagnetic field treatment for acute scaphoid fractures: a randomised double-blind placebo-controlled multicentre trial. J Bone Joint Surg Br. Oct 2012;94(10):1403-8.


Hannemann PFW, van Wezenbeek MR, Kolkman KA, et al. CT scan-evaluated outcome of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a randomised, multicentre, double-blind, placebo-controlled trial. Bone Joint J. 2014;96-B(8):1070-6. 

Heckman JD, Ryaby JP, McCabe J, et al. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34.


Kalfas I, Principles of bone healing. [Medscape Web site].  04/01/2001. Available at: http://www.medscape.com/viewarticle/405699.  Accessed June 27, 2022.


Kristiansen TK, Ryaby JP, McCabe J, et al. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73.

Lau JT, Stamatis ED, Myerson MS, Schon LC. Implantable direct-current bone stimulators in high-risk and revision foot and ankle surgery: a retrospective analysis with outcome assessment. Am J Orthop. 2007;36(7):354-7.


Leung KS, Lee WS, Tsui HF, et al. Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol. 2004;30(3):389-95.


Lubbert PH, van der Rijt RH, Hoorntje LE, et al. Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multicentre double blind randomised controlled trial. Injury. 2008;39(12):1444-52.


Martinez-Rondanelli A, Martinez JP, Moncada ME, et al. Electromagnetic stimulation as coadjuvant in the healing of diaphyseal femoral fractures: a randomized controlled trial. Colomb Med (Cali). 2014;45(2):67-71. 


National Institute for Health and Clinical Excellence. Low-intensity pulsed ultrasound to promote fracture healing. December 2010. Available online at: https://www.nice.org.uk/guidance/ipg374. Accessed June 27, 2022.


Noridian. Local Coverage Determination (LCD). L33796 Osteogenesis stimulators. [Noridian Web site]. Original: 10/01/2015. (Revised: 01/01/2020). Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33796. Accessed June 27, 2022.


Noridian Healthcare Solutions. Local Coverage Article (A52513). Billing and Coding: Osteogenesis Stimulators. [Noridian Website] Original 10/01/2015. (Revised 01/01/2020).  Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52513. Accessed June 27, 2022.

Orthofix. About Bone Growth Stimulation [Orthofix Web site]. 2022.  Available at: http://www.bonegrowththerapy.com/?gclid=EAIaIQobChMI24j54rzw6wIVgYnICh065Q4lEAAYASAAEgKkP_D_BwE.  Accessed June 27, 2022.


Pannier S. Congenital pseudarthrosis of the tibia. Orthop Traumatol Surg Res. 2011;97(7):750-61.


Petrisor B, Lau JT. Electrical bone stimulation: an overview and its use in high risk and Charcot foot and ankle reconstructions. Foot Ankle Clin. 2005;10(4):609-20.


Pountos I, Georgouli T, Blokhuis TJ, et al. Pharmacological agents and impairment of fracture healing: what is the evidence. Injury. 2008;39:384-94.


Rue JP, Armstrong DW 3rd, Frassica FJ, et al. The effect of pulsed ultrasound in the treatment of tibial stress fractures. Orthopedics. 2004;27(11):1192-5.


Rutten S, Nolte PA, Guit GL, et al. Use of low-intensity pulsed ultrasound for posttraumatic nonunions of the tibia: a review of patients treated in the Netherlands. J Trauma. 2007;62(4):902-8.


Saxena A, DiDomenico LA, Widtfeldt A, Adams T, Kim W. Implantable electrical bone stimulation for arthrodeses of the foot and ankle in high-risk patients: a multicenter study. J Foot Ankle Surg. 2005;44(6):450-4.


Schofer MD, Block JE, Aigner J, et al. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229.


Scott G, King JB. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bone. J Bone Joint Surg Am. 1994;76(6):820-6.


Sharrard WJ.  A double-blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. J Bone Joint Surg Br. 2009;72(3):347-55.


Sharrard WJ, Sutcliffe ML, Robson MJ, Maceachern AG. The treatment of fibrous non-union of fractures by pulsing electromagnetic stimulation. J Bone Joint Surg Br. 1982;64(2):189-93.


Shi HF, Xiong J, Chen YX, et al. Early application of pulsed electromagnetic field in the treatment of postoperative delayed union of long-bone fractures: a prospective randomized controlled study. BMC Musculoskelet Disord. 2013;14:35.


Simonis RB, Parnell EJ, Ray PS, et al. Electrical treatment of tibial non-union; a prospective, randomized, double-blind trial. Injury. 2003;34(5):357-62.


Summary of Safety and Effectiveness Data. Exogen 2008® or Sonic Accelerated Fracture Healing System (SAFHS®). Exogen®, a Smith and Nephew Company, Piscataway, NJ.


US Food and Drug Administration (FDA). Center for Devices and Radiological Health.  Exogen 2000® or Sonic Accelerated Fracture Healing System (SAFHS®)- P900009/S006. [FDA Web site]. 02/22/00. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P900009S006.  Accessed June 27, 2022.


US Food and Drug Administration (FDA). Center for Devices and Radiological Health. PMA Final Decisions Rendered for June 1998. Orthologic™ 1000 and CC Bone Growth Stimulator - P910066/S008. [FDA Web site]. (Revised 06/29/09). Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf/P910066S011b.pdf.  Accessed June 27, 2022.​

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

20974
20975 
20979 

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT SEMI-INVASIVE ELECTRICAL BONE GROWTH STIMULATION:

20999
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)
MEDICALLY NECESSARY

E0747 Osteogenesis stimulator, electrical, noninvasive, other than spinal applications

E0749 Osteogenesis stimulator, electrical, surgically implanted

E0760 Osteogenesis stimulator, low intensity ultrasound, noninvasive

SUPPLIES

A4559 Coupling gel or paste, for use with ultrasound device, per oz

EXPERIMENTAL/INVESTIGATIONAL

THE FOLLOWING CODE IS USED TO REPRESENT A SEMI-INVASIVE ELECTRICAL BONE GROWTH STIMULATOR:

E1399 Durable medical equipment, miscellaneous​
Revenue Code Number(s)
N/A

Modifiers

EY - No physician or other health care provider order for this item or service

KF - FDA Class III Device

Coding and Billing Requirements

Policy History

Revisions From 05.00.81:​​

​07/12/2023
​This policy has been reissued in accordance with the Company's annual review process.​​
09/07/2022

The policy has been reviewed and reissued to communicate the Company's continuing position on Osteogenic Stimulators (non-invasive, invasive/semi-invasive, electrical and ultrasound)​.​
​10/06/2021

​The policy has been reviewed and reissued to communicate the Company's continuing position on Osteogenic Stimulators (non-invasive, invasive/semi-invasive, electrical and ultrasound)​.
​01/10/2021
​This version of the policy will become effective on 1/10/2021.

 
The following new policy has been developed to communicate the Company's coverage criteria for non-invasive bone growth stimulators for the appendicular skeleton, low-intensity ultrasound accelerated fracture healing systems for the appendicular skeleton and invasive/semi-invasive electrical bone growth stimulators.


The Company has delegated the responsibility for utilization management activities for non-invasive electrical bone growth stimulators for bone healing after spinal fusion procedures including cervical, thoracic and lumbar regions to AIM Specialty Health® (AIM).


1/10/2021
1/8/2021
7/12/2023
05.00.81
Medical Policy Bulletin
Commercial
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