Powered Lower Extremity Exoskeleton - Correct Coding

Joint DME MAC and PDAC Publication

On November 13, 2023 the Centers for Medicare & Medicaid Services (CMS) published final rule CMS-1780-F that codifies the Medicare definition of a brace to the regulations at 42 CFR 410.2. This rule finalizes that powered exoskeleton devices that support a patient’s weak arms or legs are classified as braces due to their use in stabilizing, positioning, supporting, and restoring the functions of the patient’s weak limbs.

Lower extremity powered exoskeleton devices support the weak legs for a patient that can perform ambulatory functions with the device. Ambulation may include the assistance of a cane, crutches, or a walker to return to mobility activities of daily living.

K1007(BILATERAL HIP, KNEE, ANKLE, FOOT DEVICE, POWERED, INCLUDES PELVIC COMPONENT, SINGLE OR DOUBLE UPRIGHT(S), KNEE JOINTS ANY TYPE, WITH OR WITHOUT ANKLE JOINTS ANY TYPE, INCLUDES ALL COMPONENTS AND ACCESSORIES, MOTORS, MICROPROCESSORS, SENSORS) describes a wearable, motorized, and computerized device, functioning as a single or double upright microprocessor-controlled hip, knee, ankle, and foot exoskeleton. It integrates motion sensors, an onboard microprocessor system, and an exoskeleton frame, designed to support and enhance natural limb movements during walking. There are no additional add-on codes for this exoskeleton device. This powered exoskeleton device is custom fitted per the DMEPOS Quality Standards, Appendix C.

Effective for claims with dates of service on or after June 1 2024, the only products that may be billed using Healthcare Common Procedure Coding System (HCPCS) codes K1007 are those that have received mandatory code verification review and are listed on the Product Classification List (PCL) of the Pricing, Data Analysis, and Coding (PDAC) contractor website.

Currently there is one product that is coded by CMS as the result of the HCPCS public meeting and final rule implementation. The Rewalk™ by Argo Technologies which is coded as K1007.
The CMS Program Integrity Manual (CMS Pub. 100-08), Chapter 3, Sections 3.3.B and 3.6.2.4 specify that for Medicare claims, only CMS and the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have the authority to establish HCPCS Level II Coding Guidelines. Pursuant to 42 CFR § 414.40 and 45 CFR § 162.1002, CMS has the authority to assign and manage HCPCS codes (create, delete, change code narrative, etc.).

Correct coding is an essential element for correct claim payment. To assist manufacturers and suppliers with correct coding, the DME MACs are requiring mandatory code verification review by the PDAC contractor for lower extremity exoskeletal devices that might qualify for HCPCS code K1007. The application for the coding verification review is located on the PDAC website.

For questions about correct coding, contact the PDAC HCPCS Helpline at (877) 735-1326 during the hours of 9:30 a.m. to 5:00 p.m. ET, Monday through Friday. You may also visit the PDAC website to chat with a representative, or select the Contact Us website button at the top of the PDAC website for email, FAX, or postal mail information.