FES - Coverage and HCPCS Coding - Revised - JD DME

Originally Published March 2003

Updated July 10, 2014 - This revision updates the codes and adds the ACA 6407 requirements

Effective: August 1, 2014

In April 2003 the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) establishing coverage for functional electrical stimulation (FES) to enable spinal cord injured (SCI) patients to walk (see National Coverage Determinations Manual 100-3 Chapter 1, Part 2, Section 160.12).

Functional electrical stimulation 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 three months.

Coverage for FES to enhance walking will be limited to SCI patients with diagnosis, ICD-9 code 344.1 (paraplegia - paralysis of both lower limbs), or (when implemented) one of the ICD-10 codes, G04.1 –Tropical spastic paraplegia, G82.21 Paraplegia, complete, G82.22 Paraplegia, incomplete, and with all of the following characteristics:

1. Persons with intact lower motor units (L1 and below) (both muscle and peripheral nerve); and,
2. 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,
3. Persons that demonstrate brisk muscle contraction to NMES and have sensory perception of electrical stimulation sufficient for muscle contraction; and,
4. Persons that possess high motivation, commitment and cognitive ability to use such devices for walking; and,
5. Persons that can transfer independently and can demonstrate standing independently for at least three minutes; and,
6. Persons that can demonstrate hand and finger function to manipulate controls; and,
7. Persons with at least six-month post recovery spinal cord injury and restorative surgery; and,
8. Persons without hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis; and,
9. Persons who have demonstrated a willingness to use the device long-term.

FES used to enhance walking for SCI patients with any of the following conditions, will not be covered.

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.

The only settings where therapists with the sufficient skills to provide these services are employed are inpatient hospitals, outpatient hospitals, comprehensive outpatient rehabilitation facilities and outpatient rehabilitation facilities. The physical therapy necessary to perform this training must be part of a one-on-one training program.

HCPCS CODING
Two codes are used to bill for FES:

Note that HCPCS codes E0764 and E0770 represent the "entire system" for the FES devices. Therefore, individual components such as walkers, crutches or other supplies must not be billed separately.

Manufacturers of products billed with code E0770 must have the code(s) verified by the Pricing, Data Analysis, and Coding (PDAC). Currently, the only products that are coded E0770 are:

• WalkAide (Innovative Neurotronics)
• Odstock ODFS Pace FES System (Odstock Medical/Boston Brace)
• NESS L300 and H200 devices (Bioness)

Code E0764 does not require code verification by the PDAC; however, currently the only product that is coded E0764 is the Parastep I (Sigmedics).

For questions about correct coding, contact the PDAC Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form located on the PDAC website: https://www.dmepdac.com/.

DOCUMENTATION REQUIREMENTS

For E0770 to be covered by Medicare, a written signed and dated order must be received by the supplier before a claim is submitted to the DME MAC. This order must be signed and dated by the treating physician, kept on file by the supplier, and made available to the DME MAC 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 DME MAC 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.

If all the above criteria for coverage are met, HCPCS codes E0764 and E0770 must be billed with a KX modifier (REQUIREMENTS SPECIFIED IN THE MEDICAL POLICY HAVE BEEN MET). If all the coverage criteria listed above are not present, a KX modifier must not be added to the code.

The diagnosis code that describes the condition(s) requiring the use of FES must be added to the claim.

AFFORDABLE CARE ACT (ACA) 6407 REQUIREMENTS

Effective for prescriptions dated on or after July 1, 2013

ACA 6407 contains provisions that are applicable to certain specified items in this NCD. The specified items are:

PRESCRIPTION REQUIREMENTS - WRITTEN ORDERS PRIOR TO DELIVERY

ACA 6407 requires a written order prior to delivery (WOPD) for the HCPCS code E0764. The supplier must have received a complete WOPD that has been both signed and dated by the treating physician and meets the requirements for a DWO before dispensing the item. See below for information about the statutory requirements associated with a WOPD.

SPECIFIC DOCUMENTATION REQUIREMENTS

These items require an in-person or face-to-face interaction between the beneficiary and their treating physician prior to prescribing the item, specifically to document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered. A dispensing order is not sufficient to provide these items; therefore, a WOPD is required. Refer to the section below for information about these statutory requirements.

The DMEPOS supplier must have documentation of both the face-to-face visit and the completed WOPD in their file prior to the delivery of these items.

Suppliers are reminded that all Medicare coverage and documentation requirements for DMEPOS also apply. There must be sufficient information included in the medical record to demonstrate that all of the applicable coverage criteria are met. This information must be available upon request.

Statutory Requirements

FACE-TO-FACE VISIT REQUIREMENTS

As a condition for payment, Section 6407 of the Affordable Care Act (ACA) requires that a physician (MD, DO or DPM), physician assistant (PA), nurse practitioner (NP) or clinical nurse specialist (CNS) has had a face-to-face examination with a beneficiary that meets all of the following requirements:

• The treating physician must have an in-person examination with the beneficiary within the six (6) months prior to the date of the WOPD.
• This examination must document that the beneficiary was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required by Medicare:

• For all claims for purchases or initial rentals
• When there is a change in the prescription for the accessory, supply, drug, etc.
• If a local coverage determination (LCD) requires periodic prescription renewal (i.e., policy requires a new prescription on a scheduled or periodic basis)
• When an item is replaced
• When there is a change in the supplier
• When required by state law

The first bullet, "For all claims for purchases or initial rentals", includes all claims for payment of purchases and initial rentals for items not originally covered (reimbursed) by Medicare Part B. Claims for items obtained outside of Medicare Part B, e.g. from another payer prior to Medicare participation (including Medicare Advantage plans), are considered to be new initial claims for Medicare payment purposes.

PRESCRIPTION REQUIREMENTS

A WOPD is a standard Medicare Detailed Written Order, which must be completed, including the prescribing physician's signature and signature date, and must be in the DMEPOS supplier's possession BEFORE the item is delivered. The WOPD must include all of the items below:

• Beneficiary's name
• Physician's name
• Date of the order and the start date, if start date is different from the date of the order
• Detailed description of the item(s)
• The prescribing practitioner's National Provider Identifier (NPI)
• The signature of the ordering practitioner
• Signature date

For any of the specified items provided on a periodic basis, including drugs, the written order must include, in addition to the above:

• Item(s) to be dispensed
• Dosage or concentration, if applicable
• Route of Administration, if applicable
• Frequency of use
• Duration of infusion, if applicable
• Quantity to be dispensed
• Number of refills, if applicable

Note that prescriptions for these specified DME items require the National Provider Identifier to be included on the prescription. Prescriptions for other DMEPOS items do not have this NPI requirement. Suppliers should pay particular attention to orders that include a mix of items, to assure that these ACA order requirements are met.

The treating practitioner that conducted the face-to-face examination does not need to be the prescriber for the DME item. However, the prescriber must:

• Verify that the in-person visit occurred within the 6-months prior to the date of their prescription; and,
• Have documentation of the face-to-face examination that was conducted; and,
• Provide the DMEPOS supplier with copies of the in-person visit records.

DATE AND TIMING REQUIREMENTS

There are specific date and timing requirements:

• The date of the face-to-face examination must be on or before the date of the written order (prescription) and may be no older than 6 months prior to the prescription date.
• The date of the face-to-face examination must be on or before the date of delivery for the item(s) prescribed.
• The date of the written order must be on or before the date of delivery.
• The DMEPOS supplier must have documentation of both the face-to-face visit and the completed WOPD in their file prior to the delivery of these items.

A date stamp (or similar) is required which clearly indicates the supplier's date of receipt of both the face-to-face record and the completed WOPD with the prescribing physician's signature and signature date. It is recommended that both documents be separately date-stamped to avoid any confusion regarding the receipt date of these documents.

CLAIM DENIAL

Claims for the specified items subject to ACA 6407 that do not meet the requirements specified above will be denied as statutorily noncovered – failed to meet statutory requirements.

If the supplier delivers the item prior to receipt of a written order, it will be denied as statutorily noncovered. If the written order is not obtained prior to delivery, payment will not be made for that item even if a written order is subsequently obtained. If a similar item is subsequently provided by an unrelated supplier who has obtained a written order prior to delivery, it will be eligible for coverage.

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