A4559 Medicare coverage

Local coverage indication

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement: The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

Excerpt from LCD L33796 version 24, effective 01/01/2024. CMS LCD L33796.

What NCD 150.2 says the item is

Electrical Osteogenic Stimulators A. General Electrical stimulation to augment bone repair can be attained either invasively or non-invasively. Invasive devices provide electrical stimulation directly at the fracture site either through percutaneously placed cathodes or by implantation of a coiled cathode wire into the fracture site. The power pack for the latter device is implanted into soft tissue near the fracture site and subcutaneously connected to the cathode, creating a self-contained system with no external components. The power supply for the former device is externally placed and the leads connected to the inserted cathodes. With the non-invasive device, opposing pads, wired to an external power supply, are placed over the cast. An electromagnetic field is created between the pads at the fracture site. Ultrasonic Osteogenic Stimulators A.

National coverage indication, NCD 150.2

Electrical Osteogenic Stimulators B. Nationally Covered Indications Noninvasive Stimulator The noninvasive stimulator device is covered only for the following indications: Nonunion of long bone fractures; Failed fusion, where a minimum of 9 months has elapsed since the last surgery; Congenital pseudarthroses; Effective July 1, 1996, as an adjunct to spinal fusion surgery for patients at high risk of pseudarthrosis due to previously failed spinal fusion at the same site or for those undergoing multiple level fusion. A multiple level fusion involves 3 or more vertebrae (e.g., L3-L5, L4-S1, etc). Effective September 15, 1980, nonunion of long bone fractures is considered to exist only after 6 or more months have elapsed without healing of the fracture. Effective April 1, 2000, nonunion of long bone fractures is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment with the electrical osteogenic stimulator. Serial radiographs must include a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.

Excerpt from NCD 150.2 version 2. CMS NCD 150.2.

From A52513

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.

CMS source A52513

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426