Article Detail - JD DME

Retired on July 10, 2014. New article posted on July 10, 2014 and revised on August 1, 2014.

Original Effective Date: 02/17/2003
Revision Effective Date: 11/01/2013

Effective for dates of service on or after April 1, 2003, the Centers for Medicare & Medicaid Services (CMS) has issued a National Coverage Determination (NCD) establishing coverage for functional electrical stimulation (FES) to enable spinal cord injured (SCI) patients to walk. Coverage Issues Manual (CIM) Section 35-77 has been revised to reflect the new NCD.

FES is a technique that uses electrical impulses to activate paralyzed or weak muscles in precise sequence. The FES device transmits these electrical impulses via surface electrodes in the same manner as neuromuscular electrical stimulation (NMES). For example, through selective and sequential stimulation of various lower extremity muscle groups, FES can enable spinal cord injured (SCI) patients to walk.

Coverage of NMES (other than FES) to treat muscle atrophy is limited to the treatment of patients with disuse atrophy where the nerve supply to the muscle is intact, including brain, spinal cord and peripheral nerves and other non-neurological reasons for disuse atrophy. There has been no change in coverage criteria when NMES is used to treat disuse atrophy.

Coverage of FES

Medicare will consider coverage of FES for SCI patients who have completed a training program consisting of at least 32 physical therapy sessions with the device, over a period of 3 months.

Coverage for FES to enhance walking will be limited to SCI patients with an ICD-9 diagnosis of 344.1 (paraplegia – paralysis of both lower limbs) and with all of the following characteristics:

• Persons with intact lower motor units (L1 and below) (both muscle and peripheral nerve); and,
• Persons with muscle and joint stability for weight bearing at upper and lower extremities that can demonstrate balance and control to maintain an upright support posture independently; and,
• Persons that demonstrate brisk muscle contraction to NMES and have sensory perception of electrical stimulation sufficient for muscle contraction; and,
• Persons that possess high motivation, commitment and cognitive ability to use such devices for walking; and,
• Persons that can transfer independently and can demonstrate standing independently for at least 3 minutes; and,
• Persons that can demonstrate hand and finger function to manipulate controls; and,
• Persons with at least 6-month post recovery spinal cord injury and restorative surgery; and,
• Persons without hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis; and,
• Persons who have demonstrated a willingness to use the device long-term.

FES to enhance walking for SCI patients will not be covered for SCI patients with any of the following:

1. presence of cardiac pacemakers;
2. severe scoliosis or severe osteoporosis;
3. irreversible contracture;
4. autonomic dysreflexia; or
5. skin disease or cancer at area of stimulation.

Indications for FES other than to enable SCI patients to walk will be denied as not medically necessary.

Coding of FES

For dates of service on or after April 1, 2003, a new HCPCS code must be used when billing for FES:

K0600 - Functional neuromuscular stimulator, transcutaneous stimulation of muscles of ambulation with computer control, used for walking by spinal cord injured, entire system, after completion of training program

Note that code K0600 represents the "entire system" for the FES device. Therefore, individual components such as walkers, crutches or other supplies must not be billed separately.

One such device meeting the definition of code K0600 is the Parastep I System, manufactured by Sigmedics, Inc. Manufacturers or suppliers should contact the SADMERC for guidance on whether a particular device meets the definition of this HCPCS code.

K0600 must not be used for dates of service prior to April 1, 2003. Use HCPCS code E1399 and submit documentation of the manufacturer, name, model and description of the device being billed, and how it is being used. Claims for FES for dates of service prior to April 1, 2003 will be denied as not medically necessary.

Documentation of FES

For this item to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted to the DMERC. This order must be signed and dated by the treating physician, kept on file by the supplier, and made available to the DMERC upon request. If the supplier bills for this item without first receiving the completed order, the item will be denied as not medically necessary. Items billed to the DMERC before a signed and dated order has been received by the supplier must be submitted with an EY modifier (No physician or other health care provider order for this item or service) added to each affected HCPCS code.

For dates of service on or after April 1, 2003, if all the above criteria for coverage are met, HCPCS code K0600 must be billed with a KX modifier (Specific required documentation on file). If ICD-9-diagnosis code 344.1 is applicable, it must be added to the claim. If all the coverage criteria listed above are not present, a KX modifier must not be added to the code.

Please refer to the Supplier Manual for more information on orders, medical records, and supplier documentation.