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Osteogenesis Stimulators Osteogenesis Stimulators Last Review Date: July 9, 2021 Number: MG.MM.DM.08jC2 Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, (“EmblemHealth”) has adopted the herein policy in providing management, administrative and other services to EmblemHealth Plan, Inc., EmblemHealth Insurance Company, EmblemHealth Services Company, LLC and Health Insurance Plan of Greater New York (HIP) related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc. Definitions Electrical osteogenesis Electrical stimulation to augment bone repair, which can be attained either invasively or stimulator noninvasively. Invasive devices provide electrical stimulation directly at the fracture site either through percutaneously placed cathodes or by implantation of a coiled cathode wire into the fracture site. The power supply is externally placed and the leads connected to the inserted cathodes. A noninvasive electrical stimulator is characterized by an external power source that is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site. Ultrasonic osteogenesis A noninvasive device that emits low-intensity pulsed ultrasound. The ultrasound signal is stimulator applied to the skin surface at the fracture location via ultrasound-conductive coupling gel in order to stimulate fracture healing. Fresh fracture For the purpose of this guideline, a fresh fracture is considered to be one that has not yet met the definition of a nonunion (i.e. failure to heal within the expected time frame, which is generally within 12 weeks of the fracture). Nonunion/delayed union Fracture healing that has ceased for at least three months prior to the initiation of of a fracture osteogenesis stimulator treatment. Guideline Members are eligible for coverage of osteogenesis stimulators (noninvasive stimulators require the DME benefit) when the criteria for one of the following are met: Osteogenesis Stimulators Last review: Jul. 9, 2021 Page 2 of 155 A. Nonspinal electrical osteogenesis stimulator B. Spinal electrical osteogenesis stimulator C. Ultrasonic osteogenesis stimulator A. Nonspinal electrical osteogenesis stimulator. One or more of the following criteria must be met: 1. Nonunion of a long-bone fracture (clavicle, femur, tibia, fibula, humerus, radius, ulna, metacarpal, or metatarsal) defined as radiographic evidence that fracture healing has ceased for ≥ 3 months prior to the start of treatment 2. Failed fusion of a joint (other than in the spine) with ≥ 9 months' lapse since the last surgery (postsurgical arthrodesis status) 3. Congenital pseudarthrosis Nonunion of a long bone fracture must be documented by a minimum of 2 sets of radiographs obtained prior to treatment initiation separated by a minimum of 90 days (each including multiple views of the fracture site and with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the 2 sets of radiographs). B. Spinal electrical osteogenesis stimulator. One or more of the following criteria must be met: 1. Failed spinal fusion where a minimum of 9 months has elapsed since the last surgery (postsurgical arthrodesis status) 2. Post multilevel spinal fusion surgery (involves ≥ 3 vertebrae). 3. Post spinal fusion surgery where there is a history of a previously failed spinal fusion at the same site 4. Comorbid condition associated with compromised bone healing (e.g., diabetes, obesity, osteoporosis, current tobacco use) (eff. 9/14/19) 5. Spondylolisthesis grade II or greater (eff. 9/14/19) C. Ultrasonic osteogenesis stimulator. Covered in the following clinical situations: 1. Nonunion of a fracture documented by a minimum of 2 sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days (each including multiple views of the fracture site with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the 2 sets of radiographs) 2. Fresh fractures, fusions or delayed unions of the scaphoid (carpal navicular), metatarsal (proximal end, [aka Jones Fracture]), tibial shaft and distal radius 3. The fracture is not tumor related Ultrasound-conductive coupling gel is covered when the Plan covers this type of stimulator. Osteogenesis Stimulators Last review: Jul. 9, 2021 Page 3 of 155 Limitations/Exclusions Osteogenesis stimulators are not covered for stress fractures, fractures of the skull or vertebrae, tumor- related fractures. An ultrasonic osteogenesis stimulator may not be used concurrently with other noninvasive osteogenesis stimulators. Revision History 6/14/2019 Added indications of comorbid conditions and spondylolisthesis to electrical stimulation section (eff. 9/14/19) 6/8/2018 Removed adjunctive cervical fusion use from Limitations/Exclusions 5/12/2017 Communicated that stimulators are not covered post cervical fusion surgery 8/12/2016 Clarified fresh fracture, delayed union and nonunion definitions Applicable Procedure Codes 20974 Electrical stimulation to aid bone healing; noninvasive (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 Applicable ICD-10 Diagnosis Codes M43.10 Spondylolisthesis, site unspecified M43.11 Spondylolisthesis, occipito-atlanto-axial region M43.12 Spondylolisthesis, cervical region M43.14 Spondylolisthesis, thoracic region M43.15 Spondylolisthesis, thoracolumbar region M43.16 Spondylolisthesis, lumbar region M43.17 Spondylolisthesis, lumbosacral region M43.18 Spondylolisthesis, sacral and sacrococcygeal region M43.19 Spondylolisthesis, multiple sites in spine M80.0AXK Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with nonunion (eff. 10/01/2020) M80.0AXP Age-related osteoporosis with current pathological fracture, other site, subsequent encounter for fracture with malunion, (eff. 10/01/2020) M80.011K Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with nonunion M80.011P Age-related osteoporosis with current pathological fracture, right shoulder, subsequent encounter for fracture with malunion Osteogenesis Stimulators Last review: Jul. 9, 2021 Page 4 of 155 M80.012K Age-related osteoporosis with current pathological fracture, left shoulder, subsequent encounter for fracture with nonunion M80.019K Age-related osteoporosis with current pathological fracture, unspecified shoulder, subsequent encounter for fracture with nonunion M80.021K Age-related osteoporosis with current pathological fracture, right humerus, subsequent encounter for fracture with nonunion M80.022K Age-related osteoporosis with current pathological fracture, left humerus, subsequent encounter for fracture with nonunion M80.029K Age-related osteoporosis with current pathological fracture, unspecified humerus, subsequent encounter for fracture with nonunion M80.031K Age-related osteoporosis with current pathological fracture, right forearm, subsequent encounter for fracture with nonunion M80.032K Age-related osteoporosis
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