LCD/NCD Portal

L11520 L5012

 

OSTEOGENESIS STIMULATORS

 

Region IV

DME

Jurisdiction C

 

08/05/2011

 

• For any item to be covered by Medicare, it must

o be eligible for a defined Medicare benefit category

o be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

o meet all other applicable Medicare statutory and regulatory requirements.

o 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.

o 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:

o 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

o 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

o 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:

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

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

o 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:

o 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

o The fracture is not of the skull or vertebrae; and

o 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

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

812.00 - 813.93

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

815.00 - 815.19

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

820.00 - 821.39

FRACTURE OF UNSPECIFIED INTRACAPSULAR SECTION OF NECK OF FEMUR CLOSED - OTHER FRACTURE OF LOWER END OF FEMUR OPEN

823.00 - 824.9

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

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

808.0 - 808.9

CLOSED FRACTURE OF ACETABULUM - UNSPECIFIED OPEN FRACTURE OF PELVIS

810.00 - 816.13

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

820.00 - 826.1

FRACTURE OF UNSPECIFIED INTRACAPSULAR SECTION OF NECK OF FEMUR CLOSED - OPEN FRACTURE OF ONE OR MORE PHALANGES OF FOOT

 

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".

o It is expected that the patient’s medical records will reflect the need for the care provided.

o 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.

o 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.

o 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.

o The CMN may act as a substitute for a written order if it contains all of the required elements of an order.

o 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.

 

 

Sources of Information and Basis for Decision

 

A25956 - Osteogenesis Stimulators - Policy Article - Effective August 2009

 

CMN - 847 - Osteogenesis Stimulators

 

Local Coverage Determination (LCD) for Osteogenesis Stimulators (L5012)