Article - Osteogenesis Stimulators - Policy Article (A52513)

CMS National Coverage PolicyN/AArticle TextNON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULESFor 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 beneficiarys 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 availablehere.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 REQUIREMENTSIn 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.MODIFIERSGA, GZ, KF and KX MODIFIERSDevices 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 suppliers 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 GUIDELINESAn 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.