LCD Reference Article Article

Osteogenesis Stimulators - Policy Article

A52513

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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General Information

Source Article ID
N/A
Article ID
A52513
Original ICD-9 Article ID
Not Applicable
Article Title
Osteogenesis Stimulators - Policy Article
Article Type
Article
Original Effective Date
10/01/2015
Revision Effective Date
07/02/2023
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

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Article Guidance

Article Text

NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

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. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

Osteogenesis stimulators are covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

The DME MAC does not process claims for an invasive osteogenesis stimulator.

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

CERTIFICATE OF MEDICAL NECESSITY (CMN)

Providers and suppliers no longer need to submit Certificate of Medical Necessity (CMN) for services rendered on or after January 1, 2023.

  • For claims with dates of service on or after January 1, 2023 – Providers and suppliers no longer need to submit CMNs or DIFs with claims. Due to electronic filing requirements, claims received with these forms attached will be rejected and returned to the provider or supplier.
  • For claims with dates of service prior to January 1, 2023 – If the CMN or DIF is required, it must be submitted with the claim, or be on file with a previous claim.

For dates of service for which a CMN is required, a CMN, which has been completed, signed, and dated by the treating practitioner, must be kept on file by the supplier and made available upon request. The CMN may act as a substitute for the Standard Written Order (SWO) if it contains the same information as required in a SWO. The CMN for both electrical and ultrasonic osteogenesis stimulators is CMS Form 847. In addition to the order information that the treating practitioner enters in Section B, the supplier can use the space in Section C for a written confirmation of other details of the order or the treating practitioner can enter the other details directly.

MODIFIERS

GA, GZ, KF and KX MODIFIERS

Devices coded E0747, E0748 and E0760 are classified by the Food and Drug Administration as Class III devices; therefore, all claims for codes E0747, E0748 and E0760 must include the KF modifier. Claim lines billed without a KF modifier will be rejected as missing information.

Suppliers must add the KX modifier to claim lines billed for osteogenesis stimulators only if all of the coverage criteria in the “Coverage Indications, Limitations, and/or Medical Necessity” section in the related LCD have been met and evidence of such is retained in the supplier’s files and available to the DME MAC upon request.

If all of the criteria in the “Coverage Indications, Limitations, and/or Medical Necessity” section of the related LCD have not been met, the GA or GZ modifier must be added to the code. When there is an expectation of a medical necessity denial, suppliers must enter the GA modifier on the claim line if they have obtained a properly executed Advance Beneficiary Notice (ABN) or the GZ modifier if they have not obtained a valid ABN.

Claim lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.

CODING GUIDELINES

An electrical osteogenesis stimulator is a device that provides electrical stimulation to augment bone repair. A noninvasive electrical stimulator is characterized by an external power source which is attached to a coil or electrodes placed on the skin or on a cast or brace over a fracture or fusion site.

An ultrasonic osteogenesis stimulator is a noninvasive device that emits low intensity, pulsed ultrasound. The ultrasound signal is applied to the skin surface at the fracture location via ultrasound conductive coupling gel in order to stimulate fracture healing.

Effective with respect to items classified as DME after January 1, 2012, disposable equipment or equipment in which a major component required for their function is disposable does not meet the definition of durable medical equipment (42 CFR 414.202) and must be billed using HCPCS code A9270 (noncovered item or service).

Ultrasound conductive coupling gel is billed using code A4559.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.

Response To Comments

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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1 Codes

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Additional ICD-10 Information

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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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description

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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 article, 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 article should be assumed to apply equally to all Revenue Codes.

Code Description

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Other Coding Information

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
07/02/2023 R12

Revision Effective Date: 07/02/2023
CODING VERIFICATION REVIEW:
Removed: Section header and PDAC CVR information
Removed: Coding verification review information for HCPCS codes E0747, E0748 and E0760, effective for DOS on or after 12/01/2024

09/12/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

07/02/2023 R11

Revision Effective Date: 07/02/2023
CODING VERIFICATION REVIEW:
Added: Section header and PDAC CVR information
Added: Coding verification review information for HCPCS codes E0747, E0748 and E0760, effective for DOS on or after 12/01/2024

06/06/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

07/02/2023 R10

Revision Effective Date: 07/02/2023
CODING GUIDELINES:
Added: Statement regarding disposable equipment must be billed with A9270

05/16/2024: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

07/02/2023 R9

Revision Effective Date: 07/02/2023
MODIFIERS:
Added: GA, GZ, KX modifier instructions
Added: “Claim lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information” for claims with dates of service on or after July 2, 2023

05/18/2023: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

01/01/2023 R8

Revision Effective Date: 01/01/2023
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Billing information relevant to CMNs, for DOS affected by the CMN elimination

11/17/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

01/01/2020 R7

Revision Effective Date: 01/01/2020
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 FED. REG VOL 217):
Removed: “The link will be located here once it is available.”
Added: “The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.” with a hyperlink to the list

04/14/2022: At this time the 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

01/01/2020 R6

Revision Effective Date: 01/01/2020
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: Class III devices and KF modifier requirement for HCPCS codes E0747, E0748 and E0760
CODING GUIDELINES:
Removed: Class III devices and KF modifier requirements which were moved to the Policy Specific Documentation Requirements section

03/11/2021: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

01/01/2020 R5

Revision Effective Date: 01/01/2020
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Removed: REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO 42 CFR 410.38(g) section
Added: REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed. Reg Vol 217) section and related information
CERTIFICATE OF MEDICAL NECESSITY (CMN):
Revised: “physician” to “treating practitioner”
Removed: CMN form version number “(DME form 04.04C)”
Revised: “detailed written order” to “SWO”
ICD-10 CODES THAT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Covered” updated to “ICD-10 Codes that Support Medical Necessity”
ICD-10 CODES THAT DO NOT SUPPORT MEDICAL NECESSITY:
Revised: Section header “ICD-10 Codes that are Not Covered” updated to “ICD-10 Codes that DO NOT Support Medical Necessity”


02/13/2020: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article that is not a local coverage determination.

01/01/2017 R4

Revision Effective Date: 01/01/2017
CODING INFORMATION:
Removed: Bill type which was inadvertently added

02/07/2019: At this time 21st Century Cures Act applies to new and revised LCDs which require comment and notice. This revision is to an article and not a local coverage determination.

 

01/01/2017 R3 Revision Effective Date: 01/01/2017
NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
Added: 42 CFR 410.38(g)
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS:
Added: CMN requirements
RELATED LOCAL COVERAGE DOCUMENTS:
Added: LCD-related Standard Documentation Requirements Language Article
07/01/2016 R2 Effective July 1, 2016 oversight for DME MAC Articles is the responsibility of CGS Administrators, LLC 18003 and 17013 and Noridian Healthcare Solutions, LLC 19003 and 16013. No other changes have been made to the Articles.
10/01/2015 R1 Revision Effective Date: 10/31/2014
Removed: “When required by state law” from ACA new prescription requirements
Revised: Face-to-Face Requirements for treating practitioner
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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CMS Manual Explanations URLs
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Updated On Effective Dates Status
09/05/2024 07/02/2023 - N/A Currently in Effect You are here
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05/11/2023 07/02/2023 - N/A Superseded View
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