Public Statement:

Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

Neuromuscular Electrical Stimulation or functional electrical stimulation is used for two purposes. It is used to help maintain muscle tone and strength in an unused extremity when normal function is expected to return. It is used to enhance activity and self-sufficiency in individuals with spinal cord injuries. Neuromuscular Electrical Stimulation is covered with prior authorization when it is medically necessary.

Spinal cord stimulation for treatment of chronic pain is addressed in BI348.

Sacral nerve stimulation for treatment of incontinence is addressed in BI162.

1. QualChoice considers functional electrical stimulation (e.g., Parastep I System, Sigmedics, Inc., IL) medically necessary to enable members with spinal cord injury (SCI) to ambulate and requires prior authorization to ensure all of the following criteria are met:
   • Member has intact lower motor units (L1 and below); AND
   • Member can bear weight on upper and lower extremities to maintain an upright posture independently; AND
   • Member demonstrated brisk muscle contraction to neuromuscular electrical stimulation and has sensory perception of electrical stimulation sufficient for muscle contraction; AND
   • Member is highly motivated and has the cognitive ability to use such devices for walking; AND
   • Member can transfer independently and stand for at least 3 minutes; AND
   • Member possesses hand and finger function to manipulate the controls; AND
   • Member is at least 6 months post recovery of spinal cord injury and restorative surgery; AND
   • Member does not have hip and knee degenerative disease and has no history of long bone fracture secondary to osteoporosis; AND
   • The member has successfully completed a training program, which consists of at least 32 physical therapy sessions with the device over a three-month period.
2. QualChoice requires prior authorization for neuromuscular electrical stimulators (NMES).  They are considered medically necessary for disuse atrophy where the nerve supply to the muscle is intact and the member has any of the following non-neurological reasons for disuse atrophy:
   • Previous casting or splinting of a limb, OR
   • Contractures due to burn scarring, OR
   • Recent hip replacement surgery (NMES is covered until physical therapy begins), OR
   • Previous major knee surgery (when there is failure to respond to physical therapy).

NOTE:  NMES will rarely be covered for more than 60 days in these circumstances.

1. QualChoice considers diaphragmatic/phrenic pacing medically necessary for the improvement of ventilator function in stable, non-acute members with SCI and requires prior authorization to ensure all of the following criteria are met:
   • Member has high quadriplegia at or above C-3; AND
   • There are viable phrenic nerves; AND
   • Member`s diaphragm and lung function are adequate.
2. QualChoice considers electrical stimulation of the sacral anterior roots (by means of an implanted stimulator, the Vocare Bladder System) in conjunction with a posterior rhizotomy medically necessary after prior authorization ensures members  meet the following selection criteria:
   • 3 months (female members) after or 9 months (male members) after complete supra-sacral spinal cord injury; AND
   • Presence of 3 of the 4 non-vesical sacral segment reflexes (i.e., ankle jerks, bulbo-cavernous reflex, anal skin reflex, and reflex erection); AND
   • A phasic detrusor pressure rise of 35 mm H2O (female members) or 50 cm H2O (male members) on cytometry.

Codes Used In This BI:

I.        Functional electrical stimulation for walking (Parastep I System) is not considered medically necessary for members with SCI with any of the following:

                     ·            Members with cardiac pacemakers; OR

                     ·            Members with severe scoliosis or severe osteoporosis; OR

                     ·            Members with skin disease or cancer at area of stimulation; OR

                     ·            Members with irreversible contracture; OR

                     ·            Members with autonomic dysreflexia.

II.        QualChoice considers NMES experimental and investigational for improvement of muscle strength, reduction of spasticity and atrophy, and facilitation of functional motor movement due to any of the following conditions:

                     ·            Spinal cord injury; OR

                     ·            Stroke (cerebrovascular accident/CVA); OR

                     ·            Cerebral palsy; OR

                     ·            Bell`s palsy; OR

                     ·            Other upper motor neuron disorders. OR

                     ·            Atrophy or weakness following spinal surgery

III.        QualChoice considers NMES experimental and investigational for any of the following indications:

                     ·            For general muscle strengthening in healthy individuals; OR

                     ·            For cardiac conditioning; OR

                     ·            For the treatment of denervated muscles.

IV.        QualChoice considers the FES devices such as the FES Power Trainer, ERGYS, REGYS, NeuroEDUCATOR, and Spectra STIM to be exercise equipment. Most QualChoice plans exclude coverage of exercise equipment; please check benefit plan descriptions for details.

V.        QualChoice considers transurethral electrical stimulation experimental and investigational for the management of neurogenic bladder dysfunction because its effectiveness has not been established.

VI.        QualChoice considers Interferential stimulation (e.g., RS-4i Sequential Stimulator) for the control of pain experimental and investigational as there is insufficient evidence of effectiveness. (Hayes D)

VII.        QualChoice considers H-WAVE ® type stimulators experimental and investigational for any of the following indications because their effectiveness for these indications has not been established.

                     ·            To reduce pain from causes other than chronic diabetic peripheral neuropathy; OR

                     ·            To reduce edema; OR

                     ·            To accelerate healing; OR

To treat chronic pain due to ischemia.

Neuromuscular electrical stimulation (NMES) can be grouped into 2 categories: (i) stimulation of muscles to treat muscle atrophy, and (ii) enhancement of functional activity in neurologically impaired individuals. These devices use electrical impulses to activate paralyzed or weak muscles in precise sequence and have been utilized to provide spinal cord injury (SCI) patients with the ability to walk (e.g., The Parastep I System). Neuromuscular electrical stimulation used in this manner is commonly known as functional electrical stimulation (FES).

Spinal Cord Injury: In addition to enhancement of walking abilities in SCI patients, other clinical applications of FES include diaphragmatic/phrenic pacing, and spasticity control. Functional electrical stimulation has had some success in improving ventilatory function in adult patients with SCI (Glenn et al. 1984; Carter et al, 1987; Glenn et al, 1988).

However, it has not been consistently shown that spasticity decreases with long-term FES. Yarkony et al (1992) claimed that no definitive statement can be made regarding the type, the magnitude, or even the direction of the effect of electrical stimulation on the spasticity of patients with SCI. Current management strategy for this condition ranges from rehabilitative physical therapy, re-education therapeutic exercise, oral medications such as Dantrium, Valium, and Lioresal (baclofen), intrathecal infusion of baclofen, motor point blocks or nerve blocks, to destructive neurosurgical procedures (Merritt 1981).

Stroke Rehabilitation: There is insufficient evidence that FES is effective as a rehabilitative tool for patients who suffered strokes. In particular, there is little data supporting the long-term effectiveness of this modality for stroke rehabilitation.  A large RCT demonstrated no benefit of FES for improving upper limb function after stroke.  (Church 2006).

Rehabilitation Following Ligament/Knee Surgery: NMES has been shown to be an effective rehabilitative regimen for patients following ligament/knee surgery. It prevents muscle atrophy associated with knee immobilization, enables patients to ambulate sooner, and reduces the use of pain medication as well as length of hospital stay (Arvidsson 1986; Lake 1992; Gotlin et al, 1994; Snyder-Mackler et la, 1995).

Neurogenic Bladder Dysfunction: The management of patients with neurogenic bladder dysfunction entails clean intermittent catheterization, pharmacotherapy (e.g., oxybutynin, phenoxybenzamine, and anti-cholinergic medications such as tolterodine), and surgical interventions (e.g., urinary diversion or bladder augmentation). Moreover, stimulation of sacral anterior nerve roots in association with posterior rhizotomy has been used in the treatment of patients with suprasacral SCI. The FDA approved the Vocare Bladder System as a humanitarian use device based on a study of 23 patients who received device in association with posterior rhizotomy and were followed for a minimum of 3 months. Comparisons were made with the implanted stimulator turned either on or off; thus patients served as their own controls. The primary outcome measures were improvement in bladder emptying as evidenced by the ability to void more than 200 ml on demand with post-void residual urine volumes of less than 50 ml.

Cerebral Palsy: Traditionally, the adverse effects of spasticity are managed by means of pharmacotherapy, physical therapy, bracing, casting, splinting, orthopedic surgeries, and more recently selective posterior rhizotomy. Various forms of electrical stimulation have also been employed for the management of patients with CP including neuromuscular electrical stimulation (NMES), which has been used to increase range of motion, decrease spasticity, and enhance muscle rehabilitation.

Interferential Stimulation: It has been claimed that IFS is highly effective in reducing (i) pain and use of pain medications, (ii) edema and inflammation, (iii) healing time, as well as in improving (i) range of motion, (ii) activity levels, and (iii) quality of life. However, there are very few well designed studies such as randomized, double blind, controlled clinical trials that support such claims

H Wave Stimulation: H-wave stimulators have not been shown to be effective in reducing pain from causes other than chronic diabetic peripheral neuropathy, or in reducing edema or swelling. In particular, H-wave stimulation has not been demonstrated to be effective in treating chronic pain due to ischemia. In the study by Kumar and Marshall, patients with significant peripheral vascular disease were excluded from the trial. Furthermore, in a randomized controlled study (n = 112), McDowell et al (1995) reported that H-wave stimulation was not effective in reducing experimental ischemic pain.

1.  Aetna Clinical Policy Bulletins; Electrical Stimulation for Pain. Located at: http://www.aetna.com/cpb/data/CPBA0011.html

2.  Hayes Medical Technology Directory; Interferential Therapy for Pain

Functional Electrical Stimulation for Walking:

1.    Graupe D, Kohn K. Ambulation by traumatic T4-T12 paraplegics using functional neuromuscular stimulation. Crit Rev Neurosurg. 1998; 8(4):221-231.

2.    Wieler M, Stein RB, Ladouceur M, et al. Multicenter evaluation of electrical stimulation systems for walking. Archive Physical Med Rehabil. 1999; 80(5):495-500.

3.    Bonaroti D, Akers JM, Smith BT, et al. Comparison of functional electrical stimulation to long leg braces for upright mobility for children with complete thoracic level spinal injuries. Archive Phys Med Rehabil. 1999; 80(9):1047-1053.

4.    Center for Medicare and Medicaid Services (CMS). Neuromuscular electrical stimulation (NMES) for spinal cord injury. Decision Memorandum #CAG -00153R. Baltimore, MD: CMS; July 22, 2002.

5.    Center for Medicare and Medicaid Services (CMS). National Coverage Analysis (NCA). Neuromuscular Electrical Stimulation (NMES) for Spinal Cord Injury. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=160.12&ncd_version=1&show=all .

Neuromuscular Electrical Stimulation for Disuse Atrophy:

1.    Lake DA. Neuromuscular electrical stimulation: An overview and its application in the treatment of sports injuries. Sports Med. 1992; 13(5):320-336.

2.    Gotlin RS, Hershkowitz S, Juris PM, et al. Electrical stimulation effect on extensor lag and length of hospital stay after total knee arthroplasty. Arch Phys Med Rehabil. 1994; 75(9):957-959.

3.    Snyder-Mackler L, Delitto A, Bailey SL, Stralka SW. Strength of the quadriceps femoris muscle and functional recovery after reconstruction of the anterior cruciate ligament. A prospective, randomized clinical trial of electrical stimulation. J Bone Joint Surg Am. 1995; 77(8):1166-1173.

4.    Lieber RL, Silva PD, Daniel DM. Equal effectiveness of electrical and volitional strength training for quadriceps femoris muscles after anterior cruciate ligament surgery. J Orthop Res. 1996; 14(1):131-138.

5.    Latzanich CM, Gilmore R, Burke HB. Interferential current therapy for post-operative pain management. Contemp Pod Phys. November 1991, pp 7-9.

6.    Acute Pain Management Guideline Panel. Acute pain management: Operative or medical procedures and trauma. Clinical Practice Guideline. Rockville, MD: Agency for Health Care Policy and Research, February 1992.

7.    Turner JA, Deyo RA, Loeser JD, et al. The importance of placebo effects in pain treatment and research. JAMA. 1994; 271(20):1609-1614.

8.    Reitman C, Esses SI. Conservative options in the management of spinal disorders, Part I. Bed rest, mechanical and energy-transfer therapies. Am J Orthop. 1995; 24(2):109-116.

9.    Indergand HJ, Morgan BJ. Effect of interference current on forearm vascular resistance in asymptomatic humans. Phys Ther. 1995; 75(4):306-312.

Van Der Heijden GJ, Leffers P, Wolters PJ, et al. No effect of bipolar interferential electrotherapy and pulsed ultrasound for soft tissue shoulder disorders: A randomized controlled trial. Ann Rheum Dis. 1999; 58(9):530-540.

Electrical Stimulation for Stroke:

1.    Hummelsheim H, Maier-Loth ML, Eickhof C. The functional value of electrical muscle stimulation for the rehabilitation of the hand in stroke patients. Scand J Rehabil Med. 1997; 29(1):3-10.

2.    Francisco G, Chae J, Chawla H, et al. Electromyogram-triggered neuromuscular stimulation for improving the arm function of acute stroke survivors: A randomized pilot study. Arch Phys Med Rehabil. 1998; 79(5):570-575.

3.    Kagaya H, Sharma M, Kobetic R, Marsolais EB. Ankle, knee, and hip moments during standing with and without joint contractures: Simulation study for functional electrical stimulation. Am J Phys Med Rehabil. 1998; 77(1):49-54.

4.    Chae J, Bethoux F, Bohine T, et al. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998; 29(5):975-979.

5.    Church C, et al.  Randomized controlled trial to evaluate the effect of surface neuromuscular electrical stimulation to the shoulder after acute stroke.  Stroke. 2006; 37(12):2995-3001.

Neuromuscular Electrical Stimulation for Spinal Cord Injury:

1.    National Spinal Cord Injury Association. Functional electrical stimulation, clinical applications in spinal cord injury. Fact sheet no. 9. Silver Spring, MD: NSCIA, March 1992.

2.    Pentland B. Rehabilitation. Quadriplegia and cardiorespiratory fitness. Lancet. 1993; 341(8842):413-414.

3.    Sipski ML, Alexander CJ, Harris M. Long-term use of computerized bicycle ergometry for spinal cord injured subjects. Arch Phys Med Rehabil. 1993; 74(3):238-241.

4.    Krauss JC, Robergs RA, Depaepe JL, et al. Effects of electrical stimulation and upper body training after spinal cord injury. Med Sci Sports Exerc. 1993; 25(9):1054-1061.

5.    ASIA Impairment Scale Clinical Syndromes. Available at: http://www.asia-spinalinjury.org/publications/2001_Classif_worksheet.pdf .

Diaphragmatic/Phrenic Pacing:

1.    Garrido-Garcia H, Alvarez J, Escribano P, et al. Treatment of chronic ventilatory failure using a diaphragmatic pacemaker. Spinal Cord. 1998; 36(5):310-314.

2.    Grill WM, Kirsch RF. Neuroprosthetic applications of electrical stimulation. Assist Technol 2000; 12(1): 6-20.

3.    Krieger LM, Krieger AJ. The intercostal to phrenic nerve transfer: An effective means of reanimating the diaphragm in patients with high cervical spine injury. Plast Reconstr Surg. 2000; 105(4):1255-1261.

4.    Elefteriades JA, Quin JA, Hogan JF, et al. Long-term follow-up of pacing of the conditioned diaphragm in quadriplegia. Pacing Clin Electrophysiology. 2002;25(6):897-906

Sacral Nerve Stimulation:

1.    Jamil F. Towards a catheter free status in neurogenic bladder dysfunction: A review of bladder management options in spinal cord injury (SCI). Spinal Cord. 2001; 39(7):355-361.

2.    Jezernik S, Craggs M, Grill WM, et al. Electrical stimulation for the treatment of bladder dysfunction: Current status and future possibilities. Neurol Res. 2002; 24(5):413-430.

3.    The Vocare Bladder System. U.S. Food and Drug Administration. Humanitarian Use Devices. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/HDEInformation.cfm .

Transurethral Electrical Bladder Stimulation:

1.    Boone TB, Roehrborn CG, Hurt G. Transurethral intravesical electrotherapy for neurogenic bladder dysfunction in children with myelodysplasia: A prospective, randomized clinical trial. J Urol. 1992; 148(2 Pt 2):550-554.

2.    Decter RM, Snyder P, Rosvanis TK. Transurethral electrical bladder stimulation: Initial results. J Urol. 1992; 148(2 Pt 2):651-653, discussion 654.

3.    Lyne CJ, Bellinger MF. Early experience with transurethral electrical bladder stimulation. J Urol. 1993; 150(2 Pt 2):697-699.

4.    Decter RM, Snyder P, Laudermilch C. Transurethral electrical bladder stimulation: A follow-up report. J Urol. 1994; 152(2 Pt 2):812-814.

5.    Aslan AR, Kogan BA. Conservative management in neurogenic bladder dysfunction. Curr Opin Urol. 2002; 12(6):473-477.

Electrical Stimulation for Cerebral Palsy:

1.    Kuban KC, Leviton A. Cerebral Palsy. N Engl J Med. 1994; 330(3):188-195.

2.    Steinbok P, Reiner A, Kestle JR. Therapeutic electrical stimulation following selective posterior rhizotomy in children with spastic diplegic cerebral palsy: A randomized clinical trial. Dev Med Child Neurol. 1997; 39(8):515-520.

3.    Dali C, Hansen FJ, Pedersen SA, et al. Threshold electrical stimulation (TES) in ambulant children with CP: A randomized double-blind placebo-controlled clinical trial. Dev Med Child Neurol. 2002; 44(6):364-369.

4.    Detrembleur C, Lejeune TM, Renders A, Van Den Bergh PY. Botulinum toxin and short-term electrical stimulation in the treatment of equinus in cerebral palsy. Mov Disord. 2002; 17(1):162-169.

Electrical Stimulation for Bell`s Palsy:

1.    Fitzgerald DC. Role of electrical stimulation therapy for Bell`s palsy. Am J Otol. 1993; 14(4):413-414.

2.    Wolf SR. Idiopathic facial paralysis. HNO. 1998; 46(9):786-798.

3.    Buttress S, Herren K. Towards evidence based emergency medicine: Best BETs from the Manchester Royal Infirmary. Electrical stimulation and Bell`s palsy. Emerg Med J. 2002; 19(5):428.

4.     Salinas RA, Alvarez G, Alvarez MI, Ferreira J. Corticosteroids for Bell`s palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2002; (1):CD001942.

This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail.  State and federal mandates will be followed as they apply.