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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-20000-22

Original Effective Date: 10/15/02

Reviewed: 04/23/15

Revised: 10/01/16

Subject: Invasive Electrical Bone Growth Stimulator (EBGS)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Invasive electrical bone growth stimulators are implanted devices that deliver electrical current to a bone fusion site with the goal of stimulating bone growth and fracture healing. These devices require surgical implantation of a current generator in an intramuscular or subcutaneous space. An electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation. When stimulation is completed, the current generator is removed in a second surgical procedure but the electrodes may or may not be removed.

POSITION STATEMENT:

Invasive electrical bone growth stimulation meets the definition of medical necessity for the following indications:

Fracture nonunions or congenital pseudoarthroses in the appendicular skeleton (includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities) when ALL of the following are met:

At least 3 months have passed since the date of fracture

Serial radiographs (a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days) have confirmed that no progressive signs of healing have occurred

The fracture gap is 1 cm or less

The individual can be adequately immobilized

Is of an age likely to comply with non-weight bearing for fractures of the pelvis and lower extremities

As an adjunct to spinal fusion surgery in individuals at high risk for fusion failure, defined as any one of the following:

One or more previous failed spinal fusion(s)

Grade III or worse spondylolisthesis

Fusion to be performed at more than one level

Current tobacco use

Diabetes

Renal disease

Alcoholism

Steroid use

BILLING/CODING INFORMATION:

CPT Coding:

20975

Electrical stimulation to aid bone healing; invasive (operative)

HCPCS Coding:

E0749

Osteogenesis stimulator, electrical, surgically implanted

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

M43.00 – M43.09

Spondylosis

M43.10 – M43.19

Spondylolisthesis

M43.20 – M43.28

Fusion of spine

M53.9

Dorsopathy, unspecified

M8008XK, P

Age-related osteoporosis with current pathological fracture, vertebra(e), subsequent encounter for fracture with nonunion or malunion

M84.40XK, P

Pathological fracture, unspecified site, subsequent encounter for fracture with nonunion or malunion

M84.40XK, P

Pathological fracture, unspecified site, subsequent encounter for fracture with nonunion or malunion

M84.48XK, P

Pathological fracture, other site, subsequent encounter for fracture with nonunion or malunion

M84.68XK, P

Pathological fracture in other disease, other site, subsequent encounter for fracture with nonunion or malunion

M84.750G,K,P M84.759G,K,P

(G,K,P suffixes only)

Atypical femoral fracture (delayed healing, nonunion, malunion)

M96.0

Pseudarthrosis after fusion or arthrodesis

Q76.2

Congenital spondylolisthesis

S42.201G - S42.496G
(G suffix only)

Fracture of humerus, delayed healing (delayed healing, nonunion, malunion)

S49.001G - S49.199G
(G suffix only)

Physeal fracture of humerus, delayed healing (delayed healing, nonunion, malunion)

S52.001G,J;
S52.002G,J;
S52.009G,J;
S52.011G,
S52.012G,
S52.019G,
S52.021G,H,J;
S52.022G,H,J;
S52.023G,H,J;
S52.024G,H,J;
S52.025G,H,J;
S52.026G,H,J;
S52.031G,H,J;
S52.032G,H,J;
S52.033G,H,J;
S52.034G,H,J;
S52.035G,H,J;
S52.036G,H,J;
S52.041G,H,J;
S52.042G,H,J;
S52.043G,H,J;
S52.044G,H,J;
S52.045G,H,J;
S52.046G,H,J;
S52.091G,H,J;
S52.092G,H,J;
S52.099G,H,J;
S52.101G,H,J;
S52.102G,H,J;
S52.109G,H,J;
S52.111G,
S52.112G,
S52.119G,
S52.121G,H,J;
S52.122G,H,J;
S52.123G,H,J;
S52.124G,H,J;
S52.125G,H,J;
S52.126G,H,J;
S52.131G,H,J;
S52.132G,H,J;
S52.133G,H,J;
S52.134G,H,J;
S52.135G,H,J;
S52.136G,H,J;
S52.181G,H,J;
S52.182G,H,J;
S52.189G,H,J;
S52.201G,H,J;
S52.202G,H,J;
S52.209G,H,J;
S52.211G,
S52.212G,
S52.219G,
S52.221G,H,J;
S52.222G,H,J;
S52.223G,H,J;
S52.224G,H,J;
S52.225G,H,J;
S52.226G,H,J;
S52.231G,H,J;
S52.232G,H,J;
S52.233G,H,J;
S52.234G,H,J;
S52.235G,H,J;
S52.236G,H,J;
S52.241G,H,J;
S52.242G,H,J;
S52.243G,H,J;
S52.244G,H,J;
S52.245G,H,J;
S52.246G,H,J;
S52.251G,H,J;
S52.252G,H,J;
S52.253G,H,J;
S52.254G,H,J;
S52.255G,H,J;
S52.256G,H,J;
S52.261G,H,J;
S52.262G,H,J;
S52.263G,H,J;
S52.264G,H,J;
S52.265G,H,J;
S52.266G,H,J;
S52.271G,H,J;
S52.272G,H,J;
S52.279G,H,J;
S52.281G,H,J;
S52.282G,H,J;
S52.283G,H,J;
S52.291G,H,J;
S52.292G,H,J;
S52.299G,H,J;
S52.301G,H,J;
S52.302G,H,J;
S52.309G,H,J;
S52.311G,
S52.312G,
S52.319G,
S52.321G,H,J;
S52.322G,H,J;
S52.323G,H,J;
S52.324G,H,J;
S52.325G,H,J;
S52.326G,H,J;
S52.331G,H,J;
S52.332G,H,J;
S52.333G,H,J;
S52.334G,H,J;
S52.335G,H,J;
S52.336G,H,J;
S52.341G,H,J;
S52.342G,H,J;
S52.343G,H,J;
S52.344G,H,J;
S52.345G,H,J;
S52.346G,H,J;
S52.351G,H,J;
S52.352G,H,J;
S52.353G,H,J;
S52.354G,H,J;
S52.355G,H,J;
S52.356G,H,J;
S52.361G,H,J;
S52.362G,H,J;
S52.363G,H,J;
S52.364G,H,J;
S52.365G,H,J;
S52.366G,H,J;
S52.371G,H,J;
S52.372G,H,J;
S52.379G,H,J;
S52.381G,H,J;
S52.382G,H,J;
S52.389G,H,J;
S52.391G,H,J;
S52.392G,H,J;
S52.399G,H,J;
S52.501G,H,J;
S52.502G,H,J;
S52.509G,H,J;
S52.511G,H,J;
S52.512G,H,J;
S52.513G,H,J;
S52.514G,H,J;
S52.515G,H,J;
S52.516G,H,J;
S52.521G, S52.522G,
S52.529G,
S52.531G,H,J;
S52.532G,H,J;
S52.539G,H,J;
S52.541G,H,J;
S52.542G,H,J;
S52.549G,H,J;
S52.551G,H,J;
S52.552G,H,J;
S52.559G,H,J;
S52.561G,H,J;
S52.562G,H,J;
S52.569G,H,J;
S52.571G,H,J;
S52.572G,H,J;
S52.579G,H,J;
S52.591G,H,J;
S52.592G,H,J;
S52.599G,H,J;
S52.601G,H,J;
S52.602G,H,J;
S52.609G,H,J;
S52.611G,H,J;
S52.612G,H,J;
S52.613G,H,J;
S52.614G,H,J;
S52.615G,H,J;
S52.616G,H,J;
S52.621G
S52.622G, S52.629G,
S52.691G,H,J;
S52.692G,H,J;
S52.699G,H,J;
S52.90XG,H,J;
S52.91XG,H,J;
S52.92XG,H,J

Fracture of forearm, delayed healing (delayed healing, nonunion, malunion)

S59.001G - S59.299G
(G suffix only)

Physeal fracture of radius, delayed healing (delayed healing, nonunion, malunion)

S62.001G – S62.92xG
(G suffix only)

Fracture at wrist and hand level, delayed healing (delayed healing, nonunion, malunion)

S72.001J;
S72.002G – S72.92XJ
(G,H,J, suffixes only);

Fracture of femur (delayed healing, nonunion, malunion)

S79.001G – S79.199G
(G suffix only)

Physeal fracture of femur, delayed healing (delayed healing, nonunion, malunion)

S82.001G,H,J – S82.92,G,H,J
(G, H, J suffixes only)

Fracture of lower leg, including ankle, delayed healing (delayed healing, nonunion, malunion)

S89.001G – S89.399G
(G suffix only)

Physeal fracture of fibula, delayed healing (delayed healing, nonunion, malunion)

S92.001G – S92.919G
(G suffix only)

Fracture of foot and toe, except ankle, delayed healing (delayed healing, nonunion, malunion)

S99.001G,K,P; S99.002G,K,P; S99.009G,K,P; S99.011G,K,P; S99.012G,K,P; S99.019G,K,P; S99.021G,K,P; S99.022G,K,P; S99.029G,K,P; S99.031G,K,P; S99.032G,K,P; S99.039G,K,P; S99.041G,K,P; S99.042G,K,P; S99.049G,K,P; S99.091G,K,P; S99.092G,K,P; S99.099G,K,P

Calcaneus fracture (delayed healing, nonunion, malunion)

S99.101G,K,P, S99.102G,K,P, S99.109G,K,P, S99.111G,K,P, S99.112G,K,P, S99.119G,K,P, S99.121G,K,P, S99.122G,K,P, S99.129G,K,P, S99.131G,K,P, S99.132G,K,P, S99.139G-K-P, S99.141G,K,P, S99.142G,K,P; S99.149G,K,P; S99.191G,K,P; S99.192G,K,P; S99.199G,K,P

Fracture of metatarsal (delayed healing, nonunion, malunion)

S99.201G,K,P; S99.202G,K,P; S99.209G,K,P; S99.211G,K,P; S99.212G,K,P; S99.219G,K,P; S99.221G,K,P; S99.229G,K,P; S99.231G,K,P; S99.232G,K,P; S99.239G,K,P; S99.241G,K,P; S99.242G,K,P; S99.249G,K,P; S99.291G,K,P; S99.292G,K,P; S99.299G,K,P

Fracture of phalanx of toe (delayed healing, nonunion, malunion)

Z98.1

Arthrodesis status

REIMBURSEMENT INFORMATION:

Refer to sections entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Osteogenic Stimulators (150.2) located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Osteogenic Stimulation (L29245) located at fcso.com.

DEFINITIONS:

Arthrodesis: surgical fixation of the joint by a procedure designed to cause fusion of the joint surfaces by promoting the generation of bone cells.

Delayed union: a fracture that fails to consolidate (unite) within normal limits, less than 9 months (i.e., healing has slowed with no indications that union will fail).

Nonunion: fracture site that shows no visibly progressive signs of healing after 3 months or more, as confirmed by serial radiographs (i.e., bone healing has ceased).

Pseudoarthrosis (pseudarthrosis): a pathologic entity characterized by the loss or reduction of mineral elements of a weight-bearing long bone, followed by bending and pathologic fracture, with inability to form normal callus, leading to the existence of the “false joint” that gives the condition its name.

Spondylolisthesis: forward displacement of one vertebra over another, usually of the fifth lumbar over the body of the sacrum, or of the fourth lumbar over the fifth, usually due to a developmental defect.

RELATED GUIDELINES:

Non-Invasive Electrical Bone Growth Stimulators (EBGS), 09-E0000-22

OTHER:

Index terms:
EBGS
Electric bone growth stimulator
Electric stimulation
Implanted electric bone growth stimulator
Invasive electric bone growth stimulator
Osteogenesis stimulator

REFERENCES:

  1. AHRQ National Guideline Clearinghouse. Work Loss Data Institute (WLDI). NGC-10118: Hip & pelvis (acute & chronic). 2013.
  2. American Association of Neurological Surgeons (AANS). 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. July 2014. Accessed at http://www.aans.org.
  3. Blue Cross and Blue Shield Association Medical Policy. Reference Manual. 7.01.85 Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures, October 2014.
  4. Blue Cross Blue Shield Association TEC Assessments. (1992, pg. 324-51; 1993, pg. 1-12; 1993, pg. 332-51).
  5. Centers for Medicare and Medicaid Services (CMS), NCD for Osteogenic Stimulators (150.2), 08/05.
  6. ECRI, HTAIS Hotline Service Custom Reports Electrical Bone Growth Stimulation for the Lower Leg and Long Bones Updated 11/22/06.
  7. ECRI, HTAIS Hotline Service Custom Reports. Electrical Bone Growth Stimulation to Enhance Cervical Vertebrae Fusion. Updated 01/29/07.
  8. ECRI. Hot Line Response. Electrical Bone Growth Stimulation for the Wrist, Ankle, and Short Bones. Plymouth Meeting (PA): ECRI; 08/16/08.
  9. First Coast Service Options, Inc. LCD for Osteogenic Stimulation (L29245), 02/09.
  10. Hayes, Inc. Hayes Medical Technology Directory – Electrical Bone Growth Stimulation, Invasive Lansdale, PA: Hayes, Inc.; Feb 2004. Update performed 02/07/07.
  11. InterQual® 2014. CP: Procedures. Bone Graft and Implantable Stimulator, Fracture Nonunion.
  12. Latham W, et al. Bone Stimulation A Review of Its Use as an Adjunct. Techniques in Orthopaedics Volume 29, Number 4, 2014.
  13. Resnick DK, et al, Guidelines for the Performance of fusion Procedures for Degenerative Disease of the Lumbar Spine. Part 17: Bone Growth Stimulators and Lumbar Fusion. J Neurosurg: Spine 2: 737-740, 2005.
  14. Schoelles K, Snyder D, Kaczmarek J, Kuserk E, Erinoff E, Turkelson C, Coates V. The Role of Bone Growth Stimulating Devices and Orthobiologics in Healing Nonunion Fractures/Technology Assessment (Prepared by ECRI Evidence-based Practice Center (EPC) under Contract No. 290-02-0019) Rockville, MD: Agency for Healthcare Research and Quality. 09/21/05.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy and Coverage Committee on 04/23/15.

GUIDELINE UPDATE INFORMATION:

10/15/02

Medical Coverage Guideline Reformatted.

12/15/02

Medical Coverage Guideline re-numbered 09-E0000-27 to 02-20000-22 and moved to Musculoskeletal Surgery section of MCGs.

10/15/03

Annual review, references updated.

10/15/04

Review and revision of guideline; consisting of updated references, adding additional ICD-9 codes under Program Exceptions for Medicare and various formatting changes.

04/15/06

Review and revision of guideline consisting of updated references, added additional coverage criteria.

08/15/07

Review and revision of guideline consisting of updated references and reformatted guideline.

05/15/09

Scheduled review; add presence of other risk factors to the position statement. Update references.

10/15/10

Revision; related ICD-10 codes added.

03/15/11

Biennial review; position statement maintained and references updated.

05/11/14

Revision: Program Exceptions section updated.

05/15/15

Scheduled review. Position statement maintained. Reformatted guideline and updated references.

10/01/15

Revision; updated ICD10 coding section.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

ICD-10 coding update: added codes M84.750G,K,P - M84.759G,K,P; S99.001G,K,P - S99.099G,K,P; S99.101G,K,P - S99.199G,K,P; and S99.201G,K,P - S99.299G,K,P.

Date Printed: June 26, 2017: 11:45 AM