Noninvasive Osteogenic Stimulators Clarification and Suspension of Mandated Code Verification
Effective with respect to items classified as Durable Medical Equipment (DME) after January 1, 2012, equipment must have an expected life of at least three years in order to meet the definition of DME at 42 CFR 414.202. Products classified as DME on or before January 1, 2012, are not subject to the requirement to have an expected life of at least three years. In regulations published in 2013 (CMS-1526-F), CMS further clarified that new products (new make, manufacturer, model, or model number) that were not classified as DME before January 1, 2012, must meet the three-year expected life requirement at 42 CFR 414.202 in order to meet the definition of DME and be classified as DME.
It has come to our attention that there may be confusion as to the definition of DME at 42 CFR 414.202, specifically as it relates to new products versus old products that have been “grandfathered” (classified as DME prior to January 1, 2012) under the Medicare Part B benefit for DME. As a result, some new noninvasive osteogenesis stimulators that do not meet the three-year expected life requirement at 42 CFR 414.202 and are currently in use by Medicare beneficiaries may have been billed for and paid under the DME benefit category. As stated in regulations published in 2011 (CMS-1577-F), while we expect that equipment will meet the three-year standard at 42 CFR 414.202, we would continue to monitor the issue and undertake additional rulemaking if necessary (76 FR 70290). When CMS further clarified the exception to the three-year expected life requirement in 2013 (CMS-1526-F), we addressed comments that it was unclear what would be considered a modified product that would be subject to the exception to the three-year expected life requirement by stating that we will continue to consider these issues and provide additional guidance if necessary (78 FR 72236). In light of the confusion surrounding “grandfathered” noninvasive osteogenesis stimulators, CMS plans to provide additional direction regarding the three-year expected life requirement at 42 CFR 414.202 in future notice and comment rulemaking.
Until such rulemaking, the December 1, 2024 deadline for code verification requirements for noninvasive osteogenesis stimulators outlined in Policy Article A52513 no longer applies. Updated information about prior authorization requirements for osteogenesis stimulators is located here.
Payment for HCPCS Level II Code K1007
On February 29, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the final determinations for the Second Biannual (B2), 2023 HCPCS Coding Cycle. A final payment determination was not made for code K1007 at that time, but the Centers for Medicare and Medicaid Services has since received data that would support finalizing a payment determination for this code. Fee schedule amounts for HCPCS code K1007 have been established and are effective for claims with dates of service on or after April 1, 2024. Based on the average of current prices paid by other payers for the ReWalk Personal Exoskeleton® and other K1007 products, CMS has established a 2024 purchase fee schedule amount of approximately $91,031.93 for code K1007. The K1007 fee schedule amounts are now available: View the revised April 2024 Public Use File. More information on the K1007 payment determination will be updated on the Second Biannual (B2) 2023 HCPCS Public Meeting Summaries on the HCPCS Narrative Summary page in the near future.
All Medicare Round 2021 Durable Medical Equipment, Prosthetics, Orthotics, & Supplies (DMEPOS) Competitive Bidding Program (CBP) Contracts for Off-the-Shelf (OTS) back braces and OTS knee braces expired on December 31, 2023. As of January 1, 2024, there's a temporary gap in the DMEPOS CBP.
The Centers for Medicare & Medicaid Services plans to conduct bidding for the next round of the DMEPOS CBP after going through notice and comment rulemaking to further strengthen the DMEPOS CBP.
For additional information on the gap period, please see the Temporary Gap Period (PDF) fact sheet and continue to monitor the CMS.gov and Competitive Bidding Implementation Contractor (CBIC) websites for updates.
Coverage, Coding and Payment for Power Seat Elevation Equipment on Power Wheelchairs
CMS published a final Benefit Category Determination and National Coverage Determination (BCD NCD) for Seat Elevation Equipment (Power Operated) on Power Wheelchairs on May 16, 2023. This determination finds that power seat elevation equipment on Medicare-covered power wheelchairs falls within the benefit category for durable medical equipment (DME). It also provides for national coverage of power seat elevation equipment on Medicare-covered complex rehabilitative power-driven wheelchairs, as defined in 42 CFR 414.202, under the criteria specified in the NCD. In addition, the Durable Medical Equipment Medicare Administrative Contractor (DME MAC) has discretion to determine reasonable and necessary coverage of power seat elevation equipment for individuals who use Medicare-covered power wheelchairs other than complex rehabilitative power-driven wheelchairs. The final decision memorandum is available here: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=309
To submit claims to the DME MACs for power seat elevation equipment beginning May 16, 2023, outside of the exceptions noted below, suppliers must use Healthcare Common Procedure Coding System (HCPCS) code E2300 (Wheelchair accessory, power seat elevation system, any type). Additionally, HCPCS codes K0830 (Power Wheelchair, Group 2 Standard, Seat Elevator, Sling/Solid Seat/Back, Patient Weight Capacity Up to and Including 300 Pounds) and K0831 (Power Wheelchair, Group 2 Standard, Seat Elevator, Captains Chair, Patient Weight Capacity Up To and Including 300 Pounds) must be used to submit claims for individuals with Medicare using seat elevation on Group 2 power wheelchairs that are not complex rehabilitative power-driven wheelchairs. Claims submitted using HCPCS code E2300 for power seat elevation equipment on wheelchairs other than Group 5 and complex rehabilitative power-driven wheelchairs will be denied.
Effective for claims with dates of service on or after May 16, 2023, interim local fee schedule amounts for power seat elevation equipment will be established by the DME MACs for use in paying any allowed claims for power wheelchairs with power seat elevation. HCPCS coding and national fee schedule amounts for power wheelchairs with power seat elevation will be addressed as part of an upcoming HCPCS public meeting, likely later this fall. Additional details on the timing and agenda of the public meetings that will include power seat elevation coding and payment will be provided in the future at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo.
See previous Spotlight messages (PDF).
