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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Effective Date: 09/19/1995 Title: Bone Growth Stimulators
Revision Date: 01/01/2016 Document: BI086:00
CPT Code(s): 20974, 20975, 20979, E0747-E0749, E0760
Public Statement
Effective Date: a) This policy will apply to all services performed on or after the above Revision date which will become the new effective date. b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply. Bone growth stimulators are devices to assist or accelerate bone healing. They are covered if medically necessary, and require pre-authorization.
Medical Statement

The use of bone growth or fracture healing stimulators requires preauthorization.

  1. Sonic Accelerated Fracture Healing System

1.    QualChoice considers the use of the Sonic Accelerated Fracture Healing System (SAFHS) medically necessary for members to accelerate healing of fresh fractures, fusions, or delayed unions at the following high-risk sites:

·         Fresh fractures, fusions, or delayed unions 2 of the shaft (diaphysis) of the tibia that are open or segmental; or

S82.201A - S82.201C S82.201G - S82.201N S82.202A - S82.202C
S82.202G - S82.202N S82.209A - S82.209C S82.209G - S82.209N
S82.221A - S82.221C S82.221G - S82.221N S82.222A - S82.222C
S82.222G - S82.222N S82.223A - S82.223C S82.223G - S82.223N
S82.224A - S82.224C S82.224G - S82.224N S82.225A - S82.225C
S82.225G - S82.225N S82.226A - S82.226C S82.226G - S82.226N
S82.231A - S82.231C S82.231G - S82.231N S82.232A - S82.232C
S82.232G - S82.232N S82.233A - S82.233C S82.233G - S82.233N
S82.234A - S82.234C S82.234G - S82.234N S82.235A - S82.235C
S82.235G - S82.235N S82.236A - S82.236C S82.236G - S82.236N
S82.241A - S82.241C S82.241G - S82.241N S82.242A - S82.242C
S82.242G - S82.242N S82.243A - S82.243C S82.243G - S82.243N
S82.244A - S82.244C S82.244G - S82.244N S82.245A - S82.245C
S82.245G - S82.245N S82.246A - S82.246C S82.246G - S82.246N
S82.251A - S82.251C S82.251G - S82.251N S82.252A - S82.252C
S82.252G - S82.252N S82.253A - S82.253C S82.253G - S82.253N
S82.254A - S82.254C S82.254G - S82.254N S82.255A - S82.255C
S82.255G - S82.255N S82.256A - S82.256C S82.256G - S82.256N
S82.261A - S82.261C S82.261G - S82.261N S82.262A - S82.262C
S82.262G - S82.262N S82.263A - S82.263C S82.263G - S82.263N
S82.264A - S82.264C S82.264G - S82.264N S82.265A - S82.265C
S82.265G - S82.265N S82.266A - S82.266C S82.266G - S82.266N
S82.291A - S82.291C S82.291G - S82.291N S82.292A - S82.292C
S82.292G - S82.292N S82.299A - S82.299C S82.299G - S82.299N
S82.209G - S82.209N

 

 

·         Fresh fractures, fusions, or delayed unions 2 of the scaphoid (carpal navicular).

S62.001A - S62.001B S62.001G - S62.001K S62.002A - S62.002B
S62.002G - S62.002K S62.009A - S62.009B S62.009G - S62.009K
S62.011A - S62.011B S62.011G - S62.011K S62.012A - S62.012B
S62.012G - S62.012K S62.013A - S62.013B S62.013G - S62.013K
S62.014A - S62.014B S62.014G - S62.014K S62.015A - S62.015B
S62.015G - S62.015K S62.016A - S62.016B S62.016G - S62.016K
S62.021A - S62.021B S62.021G - S62.021K S62.022A - S62.022B
S62.022G - S62.022K S62.023A - S62.023B S62.023G - S62.023K
S62.024A - S62.024B S62.024G - S62.024K S62.025A - S62.025B
S62.025G - S62.025K S62.026A - S62.026B S62.026G - S62.026K
S62.031A - S62.031B S62.031G - S62.031K S62.032A - S62.032B
S62.032G - S62.032K S62.033A - S62.033B S62.033G - S62.033K
S62.034A - S62.034B S62.034G - S62.034K S62.035A - S62.035B
S62.035G - S62.035K S62.036A - S62.036B S62.036G - S62.036K
 

 

1.    QualChoice considers SAFHS for nonunion, failed arthrodesis (M96.0) and congenital Pseudoarthrosis (Q74.2) of the appendicular skeleton medically necessary if there has been no progression of healing for three or more months despite appropriate fracture care.

2.    QualChoice considers SAFHS for members with pathological fractures due to malignancy (unless the neoplasm is in remission) experimental and investigational, because the medical literature does not support its use for this indication.

3.    QualChoice considers SAFHS for fractures, failed fusions, or nonunion of the axial skeleton (skull and vertebrae) experimental and investigational because the effectiveness of SAFHS in these fractures has not been determined.

  1. Electrical Stimulation

QualChoice considers electrical bone-growth stimulators medically necessary for any of the following indications:

1.    Nonunion, failed fusions (M96.0), and congenital pseudoarthrosis (Q74.2) where there is no radiographic evidence of progression of healing for three or more months despite appropriate fracture care, or

2.    Delayed unions1 of fractures or failed arthrodesis at high risk sites (i.e., open or segmental tibial shaft fractures, carpal navicular fractures), or

S82.201A - S82.201C S82.201G - S82.201N S82.202A - S82.202C
S82.202G - S82.202N S82.209A - S82.209C S82.209G - S82.209N
S82.221A - S82.221C S82.221G - S82.221N S82.222A - S82.222C
S82.222G - S82.222N S82.223A - S82.223C S82.223G - S82.223N
S82.224A - S82.224C S82.224G - S82.224N S82.225A - S82.225C
S82.225G - S82.225N S82.226A - S82.226C S82.226G - S82.226N
S82.231A - S82.231C S82.231G - S82.231N S82.232A - S82.232C
S82.232G - S82.232N S82.233A - S82.233C S82.233G - S82.233N
S82.234A - S82.234C S82.234G - S82.234N S82.235A - S82.235C
S82.235G - S82.235N S82.236A - S82.236C S82.236G - S82.236N
S82.241A - S82.241C S82.241G - S82.241N S82.242A - S82.242C
S82.242G - S82.242N S82.243A - S82.243C S82.243G - S82.243N
S82.244A - S82.244C S82.244G - S82.244N S82.245A - S82.245C
S82.245G - S82.245N S82.246A - S82.246C S82.246G - S82.246N
S82.251A - S82.251C S82.251G - S82.251N S82.252A - S82.252C
S82.252G - S82.252N S82.253A - S82.253C S82.253G - S82.253N
S82.254A - S82.254C S82.254G - S82.254N S82.255A - S82.255C
S82.255G - S82.255N S82.256A - S82.256C S82.256G - S82.256N
S82.261A - S82.261C S82.261G - S82.261N S82.262A - S82.262C
S82.262G - S82.262N S82.263A - S82.263C S82.263G - S82.263N
S82.264A - S82.264C S82.264G - S82.264N S82.265A - S82.265C
S82.265G - S82.265N S82.266A - S82.266C S82.266G - S82.266N
S82.291A - S82.291C S82.291G - S82.291N S82.292A - S82.292C
S82.292G - S82.292N S82.299A - S82.299C S82.299G - S82.299N
S62.001A - S62.001B S62.001G - S62.001K S62.002A - S62.002B
S62.002G - S62.002K S62.009A - S62.009B S62.009G - S62.009K
S62.011A - S62.011B S62.011G - S62.011K S62.012A - S62.012B
S62.012G - S62.012K S62.013A - S62.013B S62.013G - S62.013K
S62.014A - S62.014B S62.014G - S62.014K S62.015A - S62.015B
S62.015G - S62.015K S62.016A - S62.016B S62.016G - S62.016K
S62.021A - S62.021B S62.021G - S62.021K S62.022A - S62.022B
S62.022G - S62.022K S62.023A - S62.023B S62.023G - S62.023K
S62.024A - S62.024B S62.024G - S62.024K S62.025A - S62.025B
S62.025G - S62.025K S62.026A - S62.026B S62.026G - S62.026K
S62.031A - S62.031B S62.031G - S62.031K S62.032A - S62.032B
S62.032G - S62.032K S62.033A - S62.033B S62.033G - S62.033K
S62.034A - S62.034B S62.034G - S62.034K S62.035A - S62.035B
S62.035G - S62.035K S62.036A - S62.036B S62.036G - S62.036K

 

1.    Members who have failed spinal fusion or are at high risk for fusion failure when any of the following criteria is met:

·         One or more failed fusions (M96.0, T84.498), or

·         Grade III or worse spondylolisthesis (M43.1, Q76.2), or

·         A multiple level spinal fusion involving 3 or more vertebrae, or

·         2 or more other risk factors for fusion failure are present, including:

        1. obesity, as defined by BMI ≥ 35 (E66.01 - E66.09, E66.8 - E66.9)
        2. degenerative osteoarthritis (M15.0 - M18.9) ,
        3. current smoking (F17.210 - F17.211),
        4. previous fusion surgery (Z98.1),
        5. diabetes (E10.10 - E13.9),
        6. alcoholism (F10.10 - F10.99),
        7. Renal disease (N18.1 - N18.6, N18.9).

 

Notes:  A delayed union is when there is no radiographic evidence of callous formation after 3 months of treatment.

Codes Used In This BI:

20974 – Application of electrical stimulator to aid bone healing (non-invasive)

20975 – Application of electrical stimulator to aid bone healing (invasive)

20979 – Application of low intensity ultrasound stimulator to aid bone healing

E0747 – osteogenesis stimulator, electrical, non-invasive, not spinal

E0748 – osteogenesis stimulator, electrical, non-invasive, spinal

E0749 – osteogenesis stimulator, electrical, implanted

E0760 – osteogenesis stimulator, low intensity ultrasound, non-invasive

 
Limits
  1. Bone growth stimulators are not covered for synovial pseudoarthrosis, wide fracture gaps, severe osteoporosis, avascular necrosis of the femoral head, in the presence of infection, or draining osteomyelitis.
  2. Bone growth stimulators are not covered when the indication for their use is patient non-compliance.
Background

Sonic Accelerated Fracture Healing System (SAFHS)

When applied over a fracture site, the SAFHS device produces an ultrasonic wave, which delivers mechanical pressure to the bone tissue at the fracture site. Although the mechanism by which the low intensity pulsed ultrasound device accelerates bone healing is uncertain, it is thought to promote bone formation in a manner comparable to bone responses to mechanical stress.

SAFHS for fresh fractures:

A.   In October 1994, the Food and Drug Administration (FDA) approved the Sonic Accelerated Fracture Healing System (SAFHS), manufactured by Exogen, Inc. (West Caldwell, NJ), to accelerate the healing of new bone fractures in the tibial diaphysis and Colles` fractures of the distal radius in adults. The FDA approval of the device was based in part on its review of two multi-center randomized controlled trials of the device on tibial diaphyseal fractures and distal radius (Colles`) fractures.

B.   SAFHS low intensity pulsed ultrasound has been demonstrated to significantly accelerate the time to clinical healing of fractures of the tibial diaphysis. Although SAFHS low intensity pulsed ultrasound has been demonstrated to accelerate the time to radiological healing of fresh closed Colle’s (wrist) fractures, it has not been shown to significantly reduce the time to clinical healing of these fractures.

C.   SAFHS is most likely to result in clinically significant benefits when applied to fresh fractures with poor vascularity that are slow to heal and at high risk of nonunion. Tibial fractures that are open or segmental are notorious for prolonged healing and a high incidence of delayed union and nonunion. Fractures of the scaphoid (carpal navicular) are at high risk of delayed union and nonunion. Hence, use of SAFHS may be particularly helpful in patients with these fractures.

SAFHS for delayed union and nonunion:

A.   SAFHS low intensity pulsed ultrasound was approved by the FDA in February 2000 for the treatment of established nonunion, excluding the skull and vertebrae. The FDA approval of the device was based on a review of retrospective studies of 79 patients with nonunion treated with SAFHS. Patients with pathologic fractures due to malignancy were excluded from these studies. Of the 74 completed cases, 86% healed both radiographically and clinically and 14% were failures of SAFHS treatment. The mean time to a healed fracture was 5½ months.

B.   Other evidence of the effectiveness of SAFHS for nonunion include a registry of prescription use of SAFHS for nonunion in the United States, which showed a heal rate of 82% of 429 completed cases, and a retrospective study of nonunion which showed a heal rate of 90% of 30 completed cases.
Reference

1.    Hayes Manual, ELEC1001.15, Electrical and Ultrasound bone Growth Stimulation, September 14, 1999

2.    Mayr E, Wagner S, Ecker M, et al. Ultrasound therapy for nonunion (pseud arthrosis): 3 case reports. Unfallchirurg. 1999;123:191-196.

3.    Hadjiargyrou M, McLeod K, Ryaby JP, et al. Enhancement of fracture healing by low intensity ultrasound. Clin Orthop. 1998;355 Suppl:S216-S229.

4.    Mayr E, Wagner S, Rüter A. Treatment of nonunion by means of low-intensity ultrasound. Unfallchirurg. 1997;121:958-962.

5.    Kane WJ. Direct current electrical bone growth stimulation for spinal fusion. Spine. 1988;13:163-165.

6.    Mooney V. A randomized double blind prospective study of the efficacy of pulsed electromagnetic fields for interbody fusions. Spine. 1990;15:8-12.

7.    Tejano NA, Puno R, Ignacio JM.. The use of implantable direct current stimulation in multilevel spinal fusion without instrumentation. Spine. 1996;21(16):1904-1908.

8.    Kahanovitz N. Spine update. The use of adjunctive electrical stimulation to enhance the healing of spine fusions. Spine. 1996;21(21):2523-2525.

9.    Brown E. Noninvasive electrical stimulation for fracture nonunion. Diagnostic and Therapeutic Technology Assessment, American Medical Association. Chicago, IL: American Medical Association; February 1, 1989.

10. Gudas CJ, Cann JE. Nonunion and related disorders. Clinics Podc Med Surg. 1991;8(2):321-339.

11. Albert SF, Wong E. Electrical stimulation of bone repair. Clinics Pod Med Surg. 1991;8(4):923-935.

12. Garland DE, Moses B, Salyer W. Long-term follow-up of fracture nonunion treated with PEMFs. Contemp Orthoped. 1991;22(3):295-302.

13. Basset C, Schink-Ascani M. Long-term pulsed electromagnetic field (PEMF) results in congenital pseud arthrosis. Calcif Tissue Int. 1991;49(3):216-220.

14. Scott G, King JB. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bones. J Bone Joint Surg. 1994;76A(6):820-826.

15. Holmes GB. Treatment of delayed unions and nonunion of the proximal fifth metatarsal with pulsed electromagnetic fields. Foot Ankle Int. 1994;15(10):552-556.

16. Akai M, Hayashi K. Effect of electrical stimulation on musculoskeletal systems: A meta-analysis of controlled clinical trials. Bio electromagnetics. 2002;23(2):132-143.

17. Alberta Heritage Foundation for Medical Research (AHFMR). Ultrasound treatment - nonunion fractures. Edmonton, AB: AHFMR; 1999.

18. Medical Services Advisory Committee (MSAC). Low intensity ultrasound treatment for acceleration of bone fracture healing - Exogen bone growth stimulator. Canberra, Australia: MSAC; 2001.

19. Busse JW, Bhandari M, Kulkarni AV, Tunks E. The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: A meta-analysis. Can Med Assoc J. 2002;166(4):437-441.

20. Banken R. Low-intensity ultrasound (Exogen) for the treatment of fractures. Montreal, QC: Agence d`Evaluation des Technologies et des Modes d ‘Intervention en Sante (AETMIS); 2004.

21. Punt B, den Hoed P, Stijnen T. Electromagnetic field stimulation for the treatment of delayed union or non-union of long bones (Protocol for Cochrane Review). Cochrane Database Syst Rev. 2004;(4):CD004960.

22. Centers for Medicare and Medicaid Services (CMS). Decision memo for ultrasound stimulation for nonunion fracture healing (CAG-00022R). Medicare Coverage Database. Baltimore, MD: CMS; April 27, 2005. Available at: http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=135
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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