Osteogenesis Stimulators - Policy Article

**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](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

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.

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.