Description

Bone growth stimulation is utilized to promote bone healing in difficult to heal fractures or fusions by applying electrical or ultrasonic current to the fracture/fusion site. Ultrasonic stimulation is applied externally, while electrical stimulation can be either invasive or noninvasive.

An invasive (surgically implanted) electrical bone growth stimulator (BGS) utilizes direct current to the nonhealing fracture or bone fusion site. Examples of invasive (implantable) electrical bone growth stimulators include, but may not be limited to, the OsteoGen (20/S, 20/M, 40/S, 40/M), the SpF PLUS-Mini Spinal Fusion Stimulator and the SpF-XL IIb Spinal Fusion Stimulator.

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017

Noninvasive (external) electrical BGS

Noninvasive (external) electrical BGS are devices worn on the outside of the skin. They utilize treatment coils or electrodes situated externally around the fracture or fusion site and an external power supply. There are three types of noninvasive electrical bone growth stimulators:

• Capacitive coupling (CC) devices use electrodes, which are applied to the skin to deliver the current. Examples of CC devices include, but may not be limited to, the ActaStim-S Spine Fusion Stimulator, OrthoPak Bone Growth Stimulator and SpinalPak Spinal Fusion Stimulator.
• Combined magnetic field (CMF) devices use an external coil system with a combination of direct and alternating current to produce both static and alternating magnetic fields. Examples of CMF devices include, but may not be limited to, the CMF OL1000 Bone Growth Stimulator (formerly OrthoLogic 1000) and the CMF SpinaLogic Bone Growth Stimulator.
• Pulsed electromagnetic field (PEMF) devices use an externally applied coil to deliver the current, which are pulsed on and off. Examples of PEMF devices include, but may not be limited to, the EBI Bone Healing System, the Cervical-Stim (refer to Coverage Limitations section), the Physio-Stim and the Spinal-Stim.

Ultrasonic BGS fracture healing devices utilize a signal generator and a transducer, which when placed over the fracture site on the skin, emits low intensity pulsed ultrasound (LIPUS) signals that are transmitted directly to the fracture. Examples of ultrasonic bone growth stimulators include, but may not be limited to, the AccelStim Bone Growth Stimulator and the Exogen Ultrasound Bone Healing System.

Coverage Determination

Noninvasive Electrical Bone Growth Stimulator

Humana members may be eligible under the Plan for the use of a noninvasive electrical BGS when the following criteria are met:

• As an adjunct to lumbar spinal fusion surgery for an individual at high risk of pseudoarthrosis due to either of the following:
  1. Previously failed spinal fusion surgery; OR

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

• Spinal fusion surgery is planned for more than one level; OR
• Congenital pseudoarthrosis; OR
• Failed lumbar spinal fusion when imaging studies confirm no evidence of progression of healing at a minimum of 3 months post surgery; OR
• Nonunion of a long bone* fracture and ALL of the following:
  1. Bone is noninfected; AND
  2. Bone is stable at both ends by means of cast, brace or fixation; AND
  3. The two portions of the bone involved in the nonunion are separated by less than 1 centimeter (cm); AND
  4. X-rays at least 90 days postfracture show evidence of nonhealing or nonunion; OR
• Nonspinal failed fusion when a minimum of 3 months has elapsed since the initial surgery; OR
• Risk of delayed or nonunion of fractures due to the following comorbidities OR for an individual undergoing a lumbar spinal fusion with the following comorbidities (list may not be all-inclusive):
  • Chronic kidney disease (stage 3B or higher)**
  • Current alcoholism/excessive alcohol use
  • Current chemotherapy treatment
  • Current smoking habit (cigarette, cigar, pipe)
  • Current steroid use
  • Diabetes
  • Obesity (BMI greater than or equal to 35)
  • Osteoporosis

NOTE: These risks/comorbidities are NOT applicable to, and therefore should not be considered for, any of the diagnoses/clinical scenarios that are addressed in the Coverage Limitations section (these risks/comorbidities do not override the Coverage Limitations).

Invasive (Surgically Implanted) Electrical Bone Growth Stimulator

Humana members may be eligible under the Plan for the use of an invasive electrical BGS when the following criteria are met:

• As an adjunct to lumbar spinal fusion surgery for an individual at high risk of pseudoarthrosis due to either of the following:
  1. Previously failed spinal fusion surgery; OR
  2. Spinal fusion surgery is planned for more than one level; OR
• Nonunion of long bone* fracture and ALL of the following:
  1. Bone is noninfected; AND
  2. Bone is stable at both ends by means of a cast, brace or fixation; AND
  3. The two portions of the bone involved in the nonunion are separated by less than 1 cm; AND
  4. X-rays at least 90 days post fracture show evidence of nonhealing or nonunion; OR
• Risk of delayed or nonunion of fractures due to the following comorbidities OR for an individual undergoing a lumbar spinal fusion with the following comorbidities (list may not be all-inclusive):
  • Chronic kidney disease (stage 3B or higher)**
  • Current alcoholism/excessive alcohol use
  • Current chemotherapy treatment
  • Current smoking habit (cigarette, cigar, pipe)
  • Current steroid use
  • Diabetes
  • Obesity (BMI greater than or equal to 35)

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 5 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Osteoporosis

NOTE: These risks/comorbidities are NOT applicable to, and therefore should not be considered for, any of the diagnoses/clinical scenarios that are addressed in the Coverage Limitations section (these risks/comorbidities do not override the Coverage Limitations).

Ultrasonic Bone Growth Stimulator

Humana members may be eligible under the Plan for the use of an ultrasonic BGS when the following criteria are met:

• The two portions of the bone involved are separated by less than 1 cm; AND any of the following:
• Acute (less than 90 days from injury) closed fractures of the distal radius (Colles’ fracture) treated with closed reduction and cast immobilization in a skeletally mature individual^; OR
• Acute (less than 90 days from injury) closed or grade I˄˄ open, short oblique or short spiral tibial diaphyseal fractures treated with closed reduction and cast immobilization in a skeletally mature individual^; OR
• Acute (less than 90 days from injury) fractures of the scaphoid; OR
• Acute (less than 90 days from injury) Jones fractures (fifth metatarsal); OR
• Nonunion of bones, other than the skull or vertebrae, in a skeletally mature individual^, excluding those that are related to malignancy, when X-rays at least 90 days post fracture show evidence of nonhealing or nonunion; OR
• Risk of delayed or nonunion of any acute closed fractures due to the following comorbidities (list may not be all-inclusive):
  • Chronic kidney disease (stage 3B or higher)**
  • Current alcoholism/excessive alcohol use

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 6 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Current chemotherapy treatment
• Current smoking habit (cigarette, cigar, pipe)
• Current steroid use
• Diabetes
• Obesity (BMI greater than or equal to 35)
• Osteoporosis

NOTE: These risks/comorbidities are NOT applicable to, and therefore should not be considered for, any of the diagnoses/clinical scenarios that are addressed in the Coverage Limitations section (these risks/comorbidities do not override the Coverage Limitations).

*Long bones are primarily found in the extremities and are comprised of a shaft (diaphysis) and two ends (epiphysis). Long bones, which are not straight but slightly curved, include the clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpals, metatarsals and phalanges.

**Chronic kidney disease, for the purposes of this Medical Coverage Policy, is defined as stage 3B or higher (glomerular filtration rate [GFR] 44 or less).^Skeletally mature refers to a system of fused skeletal bones, which occurs when bone growth ceases after puberty; for females, this generally occurs around 16 years of age, and for males, around 18 years of age.^˄Grade I denotes that the skin opening is 1 cm or less and minimal muscle contusion.

Telecommunication, wireless transmission and/or smartphone applications (eg, EXOGEN CONNECTS, OrthoFix STIM onTrack) used with bone growth stimulators to monitor compliance is considered integral to the device itself and not separately reimbursable.

Note: The criteria for bone growth stimulators are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 7 of 12

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Humana members may NOT be eligible under the Plan for noninvasive or invasive electrical bone growth stimulators for any indications other than those listed above including, but not limited to, stress fractures. All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for the use of ultrasonic bone growth stimulators for any indications other than those listed above including, but may not be limited to:

• Fractures in which the gap exceeds 1 cm; OR
• Acute fractures (less than 90 days from injury) in locations other than the distal radius, tibial diaphysis, fifth metatarsal (Jones fracture only) or scaphoid; OR
• Tibial diaphyseal or tibial and fibular fractures treated with closed reduction and intramedullary nailing and no risk factors for poor or prolonged healing; OR
• Preoperative use for fractures that require surgical intervention, or internal or external fixation (use of ultrasonic BGS for fractures in the preoperative period would not be covered); OR
• Stress fractures

All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for bone growth stimulators (regardless of the type) for the following indications:

• Cervical or thoracic level spinal fusion; OR
• Fractures due to osteoporosis; OR
• Spondylolysis (pars interarticularis defect)

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 8 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about fractures and spinal fusions may be found from the following websites:

• American Academy of Orthopaedic Surgeons
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Provider Claims Codes

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 9 of 12

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

References

• American Academy of Orthopaedic Surgeons (AAOS). Evidence-Based Clinical Practice Guideline. Treatment of clavicle fractures. https://www.aaos.org. Published December 2, 2022. Accessed December 15, 2022.
• Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Osteogenic stimulators (150.2). https://www.cms.gov. Published April 27, 2005. Accessed December 14, 2022.
• Congress of Neurological Surgeons (CNS). Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 17: bone growth stimulators as an adjunct for lumbar fusion. https://www.cns.org. Published 2014. Accessed December 15, 2022.
• ECRI Institute. Clinical Evidence Assessment. Cervical-Stim electrical bone growth stimulation (Orthofix Medical, Inc.) for facilitating healing after cervical fusion. https://www.ecri.org. Published February 23, 2021. Accessed December 7, 2022.
• ECRI Institute. Hotline Response (ARCHIVED). Electric bone growth stimulating devices for treating acute and nonunion bone fractures. https://www.ecri.org. Published July 15, 2012. Updated February 10, 2016. Accessed December 7, 2022.
• ECRI Institute. Hotline Response (ARCHIVED). Electrical bone growth stimulation for long bones. https://www.ecri.org. Published April 7, 2009. Accessed December 7, 2012.
• Bone Growth Stimulators Effective Date: 02/27/2023 Revision Date: 02/27/2023 Review Date: 02/02/2023 Policy Number: HUM-0424-017 Page: 10 of 12
• Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
• ECRI Institute. Hotline Response (ARCHIVED). Electrical bone growth stimulation for the wrist, ankle and short bones. https://www.ecri.org. Published August 18, 2008. Accessed December 7, 2012.
• Hayes, Inc. Evidence Analysis Research Brief. AccelStim Bone Growth Stimulator (Orthofix US LLC) for treatment of nonunion or fresh bone fractures. https://evidence.hayesinc.com. Published December 22, 2022. Accessed December 27, 2022.
• Hayes, Inc. Evidence Analysis Research Brief. Noninvasive electric bone growth stimulation for cervical spinal fusion. https://evidence.hayesinc.com. Published January 28, 2022. Accessed December 7, 2022.
• Hayes, Inc. Evidence Analysis Research Brief. Noninvasive electric bone growth stimulation for nonspinal arthrodesis. https://evidence.hayesinc.com. Published January 4, 2022. Accessed December 7, 2022.
• Hayes, Inc. Evidence Analysis Research Brief. Ultrasound bone growth stimulation for foot and ankle nonunion or delayed union fractures. https://evidence.hayesinc.com. Published February 4, 2022. Accessed December 7, 2022.
• Hayes, Inc. Evidence Analysis Research Brief. Ultrasound bone growth stimulation for nonspinal arthrodesis. https://evidence.hayesinc.com. Published January 7, 2022. Accessed December 7, 2022.
• Hayes, Inc. Medical Technology Directory (ARCHIVED). Electrical bone growth stimulation, invasive. https://evidence.hayesinc.com. Published July 21, 2016. Updated November 4, 2020. Accessed December 7, 2022.
• Hayes, Inc. Medical Technology Directory (ARCHIVED). Noninvasive electrical bone growth stimulators for acute, delayed union, and nonunion fractures.

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 10 of 12

• Hays, Inc. Medical Technology Directory (ARCHIVED). Noninvasive electrical bone growth stimulators for spinal fusion or foot and ankle indications. https://evidence.hayesinc.com. Published June 30, 2016. Updated October 21, 2020. Accessed December 7, 2022.
• MCG Health. Bone growth stimulators, electrical and electromagnetic. 26th edition. https://www.mcg.com. Accessed November 8, 2022.
• MCG Health. Bone growth stimulators, ultrasonic. 26th edition. https://www.mcg.com. Accessed November 8, 2022.
• North American Spine Society (NASS). Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Diagnosis and treatment of low back pain. https://www.spine.org. Published 2020. Accessed December 15, 2022.
• North American Spine Society (NASS). NASS Coverage Policy Recommendations. Electrical stimulation for bone healing. https://www.spine.org. Published October 2016. Accessed December 15, 2022.
• UpToDate, Inc. Ankle fractures in adults. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.
• UpToDate, Inc. Definition and staging of chronic kidney disease in adults. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.
• UpToDate, Inc. Distal radius fractures in adults. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.
• UpToDate, Inc. General principles of definitive fracture management. https://www.uptodate.com. Updated November 17, 2022. Accessed December 13, 2022.
• UpToDate, Inc. General principles of fracture management: bone healing and fracture description. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.
• UpToDate, Inc. General principles of fracture management: early and late complications. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.
• UpToDate, Inc. Overview of stress fractures. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.
• UpToDate, Inc. Overview of tibial fractures in adults. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.
• UpToDate, Inc. Proximal fifth metatarsal fractures. https://www.uptodate.com. Updated November 10, 2022. Accessed December 13, 2022.
• UpToDate, Inc. Scaphoid fractures. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022.

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 11 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Bone Growth Stimulators Effective Date: 02/27/2023

Revision Date: 02/27/2023

Review Date: 02/02/2023

Policy Number: HUM-0424-017 Page: 12 of 12

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.