L29245-LCD

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Automated World Health

Local Coverage Determination (LCD) for Osteogenic Stimulation (L29245)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29245

LCD Title Osteogenic Stimulation

Contractor's Determination Number 20974

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009

Original Determination Ending Date

Revision Effective Date

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-03, Medicare National Coverage Determination, Chapter 1, Section 150.2

Indications and Limitations of Coverage and/or Medical Necessity

Electrical stimulation to augment bone repair can be attained either invasively or 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 pack for the latter device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode, creating a self-contained system with no external components. The power supply for the former device is externally placed and the leads are connected to the inserted cathodes. With the noninvasive device, opposing pads, wired to an external power supply, are placed over the cast. An electromagnetic field is created between the pads at the fracture site.

An ultrasonic osteogenic stimulator is a non-invasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound using conductive gel in order to stimulate fracture healing.

Noninvasive Stimulator (procedure code 20974):

The noninvasive stimulator device is covered only for the following indications:

• Nonunion of long bone fractures;

• Failed fusion, where a minimum of nine months has elapsed since the last surgery;

• Congenital pseudarthroses; and

• As an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc.).

Invasive (Implantable) Stimulator (procedure code 20975):

The invasive stimulator device is covered only for the following indications:

• Nonunion of long bone fractures; and

Effective for services performed on or after April 1, 2000, nonunion of long bone fractures, for both noninvasive and invasive devices, is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for three or more months prior to starting treatment with the electrical osteogenic stimulator. Serial radiographs must include a minimum of two sets of radiographs, each including multiple views of the fracture

site, separated by a minimum of 90 days.

Ultrasonic Osteogenic Stimulators (procedure code 20979):

Effective for services performed on or after January 1, 2001, ultrasonic osteogenic stimulators are covered as medically reasonable and necessary for the treatment of non-union fractures. In demonstrating nonunion of fractures, we would expect:

• A minimum of two sets of radiographs obtained prior to starting treatment with the osteogenic stimulator, separated by a minimum of 90 days. Each radiograph must include views of the fracture site accompanied with a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs.

• Indications that the patient failed at least one surgical intervention for the treatment of the fracture.

Non-union fractures of the skull, vertebrae, and those that are tumor-related are excluded from coverage. The ultrasonic stimulator may not be used concurrently with other non-invasive osteogenic devices. The national non- coverage policy related to ultrasonic osteogenic stimulators for fresh fractures and delayed unions remains in place.

Effective for services performed on or after April 27, 2005, ultrasonic osteogenic stimulators are covered as medically reasonable and necessary for the treatment of non-union bone fractures prior to surgery. In demonstrating non-union fractures, the following criteria must be met:

• A minimum of 2 sets of radiographs, obtained prior to starting with the osteogenic stimulator separated by a minimum of 90 days.

• Each radiograph set must include multiple views of the fracture site accompanied 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.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS 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)

ICD-9 Codes that Support Medical Necessity

For procedure code 20974, the following ICD-9 codes apply:

724.9 OTHER UNSPECIFIED BACK DISORDERS

733.81 MALUNION OF FRACTURE

733.82 NONUNION OF FRACTURE

996.44 PERI-PROSTHETIC FRACTURE AROUND PROSTHETIC JOINT V45.4* POSTSURGICAL ARTHRODESIS STATUS

* According to the ICD-9-CM book, diagnosis code V45.4 is a secondary diagnosis code and should not be billed as a primary diagnosis.

For procedure code 20975, the following ICD-9 codes apply:

724.9 OTHER UNSPECIFIED BACK DISORDERS

733.81 MALUNION OF FRACTURE

733.82 NONUNION OF FRACTURE

738.4 ACQUIRED SPONDYLOLISTHESIS

756.12 SPONDYLOLISTHESIS CONGENITAL

909.3 LATE EFFECT OF COMPLICATIONS OF SURGICAL AND MEDICAL CARE

996.44 PERI-PROSTHETIC FRACTURE AROUND PROSTHETIC JOINT V45.4* POSTSURGICAL ARTHRODESIS STATUS

* According to the ICD-9-CM book, diagnosis code V45.4 is a secondary diagnosis code and should not be billed as a primary diagnosis.

For procedure code 20979, the following ICD-9 code applies:

733.82 NONUNION OF FRACTURE

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Documentation must support that this service meets the requirements as listed in the "Indications and Limitations of Coverage and/or Medical Necessity" section of the policy. This information is normally found in the office/progress notes and/or operative report.

Appendices

Utilization Guidelines The ultrasonic method of osteogenic stimulation is generally performed in the residence of the beneficiary. Therefore, it would be generally expected to see only one electrical or ultrasonic stimulator

service billed per beneficiary per episode of injury.

Sources of Information and Basis for Decision

N/A Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this

LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number Original

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29245) replaces LCD L6046 as the policy in notice. This document (L29245) is effective on 02/02/2009.

Reason for Change