L5012-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Osteogenesis Stimulators

(L5012)

Contractor Information

Contractor Name

CGS Administrators, LLC opens in new window

Contractor Number 18003

Contractor Type DME MAC

Jurisdiction J - G

LCD Information

Document Information

LCD ID Number L5012

LCD Title

Osteogenesis Stimulators

Contractor's Determination Number OSTG

AMA CPT/ADA CDT Copyright Statement

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.

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico

South Carolina Tennessee Texas

Virginia

Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 10/01/1993 Original Determination Ending Date

Revision Effective Date

For services performed on or after 08/05/2011

Revision Ending Date

CMS National Coverage Policy

CMS Pub. 100-3 (Medicare National Coverage Determination Manual), Chapter 1, Section 150.2 Indications and Limitations of Coverage and/or Medical Necessity

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. For the items addressed in this medical policy, the criteria for "reasonable and necessary" are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed order, the item will be denied as not medically necessary.

A nonspinal electrical osteogenesis stimulator (E0747) is covered only if any of the following criteria are met:

1. Nonunion of a long bone fracture (ICD-9 codes: 810.00-810.13, 812.00-813.93, 815.00-815.19, 820.00-

821.39, 823.00-824.9, 825.25, and 825.35) (see Appendices section) defined as radiographic evidence that fracture healing has ceased for three or more months prior to starting treatment with the osteogenesis stimulator, or

2. Failed fusion of a joint other than in the spine (ICD-9 code V45.4) where a minimum of nine months has elapsed since the last surgery, or

3. Congenital pseudarthrosis (ICD-9 code 755.8).

Nonunion of a long bone fracture must be documented by a minimum of two 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, and 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.

A nonspinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.

A spinal electrical osteogenesis stimulator (E0748) is covered only if any of the following criteria are met:

1. Failed spinal fusion (ICD-9 code V45.4) where a minimum of nine months has elapsed since the last surgery, or

2. Following a multilevel spinal fusion surgery (ICD-9 code V45.4) (see Appendices section), or

3. Following spinal fusion surgery (ICD-9 code V45.4) where there is a history of a previously failed spinal fusion at the same site.

A spinal electrical osteogenesis stimulator will be denied as not medically necessary if none of the criteria above are met.

An ultrasonic osteogenesis stimulator (E0760) is covered only if all of the following criteria are met:

1. Nonunion of a fracture (ICD-9 codes: 807.00-807.3, 808.0-808.9, 810.00-816.13, 820.00-826.1)

documented by 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 set must include multiple views of the fracture site accompanied by a written interpretation by a physician stating that there has been no clinically significant evidence of fracture healing between the two sets of radiographs; and

2. The fracture is not of the skull or vertebrae; and

3. The fracture is not tumor related.

An ultrasonic osteogenesis stimulator will be denied as not medically necessary if any of the criteria above are not met.

Use of an ultrasonic osteogenic stimulator for the treatment of a fresh fracture or delayed union will be denied as not medically necessary.

Ultrasound conductive coupling gel is covered and separately payable if an ultrasonic osteogenesis stimulator is covered.

An ultrasonic osteogenesis stimulator will be denied as not medically necessary if it is used with other noninvasive osteogenesis stimulators.

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.

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service KF - FDA Class III Device

EQUIPMENT:

E0747 OSTEOGENESIS STIMULATOR, ELECTRICAL, NON-INVASIVE, OTHER THAN SPINAL APPLICATIONS E0748 OSTEOGENESIS STIMULATOR, ELECTRICAL, NON-INVASIVE, SPINAL APPLICATIONS

E0760 OSTEOGENESIS STIMULATOR, LOW INTENSITY ULTRASOUND, NON-INVASIVE E1399 DURABLE MEDICAL EQUIPMENT, MISCELLANEOUS

SUPPLIES:

A4559 COUPLING GEL OR PASTE, FOR USE WITH ULTRASOUND DEVICE, PER OZ

ICD-9 Codes that Support Medical Necessity

The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on “Indications and Limitations of Coverage and/or Medical Necessity” for other coverage criteria and payment information.

For HCPCS code E0747:

755.8 OTHER SPECIFIED CONGENITAL ANOMALIES OF UNSPECIFIED LIMB

810.00 - 810.13 opens in new window

CLOSED FRACTURE OF CLAVICLE UNSPECIFIED PART - OPEN FRACTURE OF ACROMIAL END OF CLAVICLE

812.00 - 813.93 opens in new window

815.00 - 815.19 opens in new window

820.00 - 821.39 opens in new window

823.00 - 824.9 opens in new window

FRACTURE OF UNSPECIFIED PART OF UPPER END OF HUMERUS CLOSED - FRACTURE OF UNSPECIFIED PART OF RADIUS WITH ULNA OPEN

CLOSED FRACTURE OF METACARPAL BONE(S) SITE UNSPECIFIED - OPEN FRACTURE OF MULTIPLE SITES OF METACARPUS

FRACTURE OF UNSPECIFIED INTRACAPSULAR SECTION OF NECK OF FEMUR CLOSED

- OTHER FRACTURE OF LOWER END OF FEMUR OPEN

CLOSED FRACTURE OF UPPER END OF TIBIA - UNSPECIFIED FRACTURE OF ANKLE OPEN

825.25 FRACTURE OF METATARSAL BONE(S) CLOSED

825.35 FRACTURE OF METATARSAL BONE(S) OPEN

V45.4 POSTSURGICAL ARTHRODESIS STATUS

For HCPCS code E0748:

V45.4 POSTSURGICAL ARTHRODESIS STATUS

For HCPCS code E0760:

807.00 - 807.3 opens in

new window CLOSED FRACTURE OF RIB(S) UNSPECIFIED - OPEN FRACTURE OF STERNUM

808.0 - 808.9 opens in

new window CLOSED FRACTURE OF ACETABULUM - UNSPECIFIED OPEN FRACTURE OF PELVIS

810.00 - 816.13 opens in new window

820.00 - 826.1 opens in new window

CLOSED FRACTURE OF CLAVICLE UNSPECIFIED PART - OPEN FRACTURE OF MULTIPLE SITES OF PHALANX OR PHALANGES OF HAND

FRACTURE OF UNSPECIFIED INTRACAPSULAR SECTION OF NECK OF FEMUR CLOSED

- OPEN FRACTURE OF ONE OR MORE PHALANGES OF FOOT

Diagnoses that Support Medical Necessity Refer to the previous section.

ICD-9 Codes that DO NOT Support Medical Necessity

All ICD-9 codes and diagnoses that are not specified in the preceding sections.

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

Diagnoses that DO NOT Support Medical Necessity

All diagnoses that are not specified in the preceding section. Back to Top

General Information

Documentations Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider". It is expected that the patient’s medical records will reflect the need for the care provided. The patient’s medical records include the physician’s office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

An order for each item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

For electrical and ultrasonic osteogenesis stimulators, a Certificate of Medical Necessity (CMN) which has been completed, signed, and dated by the treating physician must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for a written order if it contains all of the required elements of an order. The CMN for both electrical and ultrasonic osteogenesis stimulators is a CMS Form 847 (DME 04.04C). The initial claim must include an electronic copy of the CMN.

All claims for an osteogenesis stimulator and related supplies must include an ICD-9 code that describes the condition requiring the device.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices A multilevel spinal fusion is one which involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc).

A long bone is limited to a clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal, or metatarsal.

Utilization Guidelines Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision

Reserved for future use. Advisory Committee Meeting Notes

Start Date of Comment Period 04/16/1993

End Date of Comment Period 05/31/1993

Start Date of Notice Period 08/01/1993

Revision History Number 011

Revision History Explanation 08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Revision Effective Date: 08/08/2009

This policy was updated by the ICD-9 2009-2010 Annual Update.

Revision Effective Date: 08/01/2009 DOCUMENTATION REQUIREMENTS:

Included: Ultrasonic in statement regarding correct CMN to use for electrical osteogenesis stimulators.

Revision Effective Date: 03/01/2008

In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

06/01/2007 In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

Revision Effective Date: 01/01/2007 INDICATIONS AND LIMITATIONS OF COVERAGE:

Eliminated the requirement to report ICD-9 code 733.82 for nonunions. HCPCS CODES AND MODIFIERS:

Added: A4559

Removed: HCPCS modifier KX Deleted:E1399

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Eliminated 733.82 from the code set for E0747 and E0760 DOCUMENTATION REQUIREMENTS:

CMN form revised: Added new DME form number and new requirement of completed CMN for ultrasonic osteogenesis stimulators.

Removed: Statement regarding using KX HCPCS Modifier when submitting claims for ultrasonic osteogenesis stimulator(s).

Removed statement regarding using KX HCPCS Modifier when submitting claims for ultrasonic osteogenesis stimulator(s).

Removed: Verbiage referring to HCPCS code E1399. LCD ATTACHMENTS:

Attached the new CMN

03/01/2006 In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

04/27/2005 LMRP converted to LCD and Policy Article

INDICATIONS AND LIMITATIONS OF COVERAGE AND OR MEDICAL NECESSITY:

Revised policy to be consistent with NCD changes. HCPCS CODES & MODIFIER

Added: KF modifier DOCUMENTATION SECTION:

Added requirement for KF modifier for Class III Devices.

Revision Effective Date: 04/01/2003 HCPCS CODES AND MODIFIERS:

Added: EY modifier to HCPCS Modifier array. INDICATIONS AND LIMITATIONS OF COVERAGE:

Added standard verbiage concerning coverage of items without an order.

Added standard verbiage concerning the use of the EY modifier when no order is present for item on claim. CODING GUIDELINES:

Moved definition of equipment here. DOCUMENTATION REQUIREMENTS:

Added standard language concerning use of the EY modifier for items without an order.

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

07/01/2002 - Replaced ZX modifier with KX modifier. 04/01/2001 - The major changes are:

1. Ultrasonic osteogenesis stimulators (E0760) are covered under conditions specified in the recent revision to Medicare Coverage Issues Manual, Section 35-48.

2. Use a ZX modifier if coverage criteria for an ultrasonic osteogenesis stimulator are met. (The ZX modifier is not for use with electrical osteogenesis stimulators E0747 and E0748.)

3. The Certificate of Medical Necessity (CMN) will not be used for ultrasonic osteogenesis stimulators, but will continue to be used for electrical osteogenesis stimulators.

4. Relevant ICD-9 diagnosis codes are required on claims for all osteogenesis stimulators, electrical and ultrasonic. For patients with nonunion of a fracture, in addition to the generic code for nonunion (733.82) the policy also requires the ICD-9 diagnosis code specifying the fracture site.

Coverage for ultrasonic osteogenesis stimulators became effective for claims with dates of service on or after January 1, 2001. The revised documentation requirements for all osteogenesis stimulators are effective for claims with dates of service on or after July 1, 2001.

The ultrasonic osteogenesis stimulator is in the Inexpensive or Routinely Purchased (IRP) payment category.

10/01/2000 - The description of a fracture nonunion is being clarified by indicating that the required radiographs must show no clinically significant healing. An article in the Spring 2000 DMERC Dialogue stated until the wording of question 6a on the Osteogenesis Stimulators CMN is revised to more clearly describe the new definition of a fracture nonunion, suppliers must attach a specific statement to each CMN that is sent to a physician. That statement is revised to say: “For purposes of answering question 6a on the attached Certificate of Medical Necessity (CMN), a fracture nonunion is considered to exist only when a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days and each including multiple views of the fracture site, have been interpreted by a physician in writing as showing that there has been no clinically significant evidence of fracture healing between the two sets of radiographs. If this definition of nonunion is not met, question 6a must be answered No.”

04/01/2000 - The major change in the policy is a revision of the definition of nonunion of a long bone fracture which is one of the conditions for which a nonspinal electrical osteogenesis stimulator (E0747) is covered. This is the result of a change in the national policy in the Medicare Coverage Issues Manual 35-48. The revised policy is effective for claims with dates of service on or after April 1, 2000. The policy also clarifies the bones that are considered long bones.

Until such time as the wording of question 6a on the Osteogenesis Stimulators CMN (04.03C) can be revised to more clearly describe the new definition of a fracture nonunion, with each CMN that is sent to a physician the supplier must attach the following statement: "For purposes of answering question #6a on the attached Certificate of Medical Necessity (CMN), a fracture nonunion is considered to exist only when a minimum of two sets of radiographs obtained prior to starting treatment with the osteogenesis stimulator, separated by a minimum of 90 days and each including multiple views of the fracture site, have been interpreted by a physician in writing as showing that there has been no evidence of fracture healing between the two sets of radiographs. If this definition of nonunion is not met, question 6a must be answered No."

06/01/1997 – Added HCPCS code E0760 including definition in Definition section. Coverage and Payment Rules section: Revised criteria 1 for nonspinal electrical osteogenesis stimulation to “after six or more months.” Added “at the same site” to criteria 3 for spinal electrical osteogenesis stimulator. Added non-coverage language for E0760. Revised Documentation section.

04/01/1996 – Removed HCPCS code E0749, added code E0748. Revised Definition section. Incorporated Indications section into Coverage and Payment Rules section and expanded language regarding coverage criteria. Added Coding Guidelines section and revised Documentation section.

12/01/1993 – Corrected HAO to HA0 in Documentation section

Reason for Change Maintenance (annual review with new changes, formatting, etc.)