Aetna FES NMES Coverage & Prior Auth Policy Update

Coverage Summary & Scope

Coverage summary: Aetna's policy takes a mixed stance: several FES/NMES and implantable stimulation interventions are covered when specific selection criteria and documentation requirements are met, while many other uses are considered experimental/investigational. Status: CURRENT (effective 2004-02-06; last review 2024-02-27; next review 2024-07-25). Headline thresholds: FES ambulation (Parastep I) requires completion of at least 32 PT training sessions over 3 months and the ability to stand ≥3 minutes; NMES daily usage limited to ≤ 2 hours per 24-hour period; Vocare (sacral anterior root) timing is ≥ 3 months (female) or ≥ 9 months (male) after complete supra-sacral SCI with specified cystometry pressure thresholds; diaphragmatic pacing requires ability to breathe ≥ 4 continuous hours/day without mechanical ventilator assistance when used for ventilatory improvement. Detailed CPT/HCPCS/ICD-10 groups and coverage conditions are enumerated in the policy for each covered indication.

Quick thresholds & facts

FES training sessionsAt least 32 physical therapy sessions over a 3-month period

FES standing abilityMember can transfer independently and stand for at least 3 minutes

NMES daily usageNo more than 2 hours per 24-hour period (more than 2 hours not medically necessary)

Estimated phrenic/diaphragmatic pacing implants worldwideApproximately 1,000 people have received phrenic pacing devices

DPS FDA trial implants (2000-2007)88 patients implanted in FDA multi-center trials

Detailed Medical Necessity Criteria

Experimental, Investigational, and Not Medically Necessary Interventions

Experimental / Investigational (Not Medically Necessary)

Aetna considers the following interventions experimental and investigational (not medically necessary) because effectiveness has not been established:

FES of the upper extremities (e.g., NESS H200 Handmaster NMS1 System) for all indications, including improvement of muscle strength, reduction of spasticity and atrophy, and facilitation of functional motor movement due to spinal cord injury, stroke (cerebrovascular accident/CVA), traumatic brain injury, or other upper motor neuron disorders (e.g., Parkinson's disease).

FES and NMES for all other indications not listed as medically necessary, including but not limited to: Bell's palsy; cardiac conditioning; cerebral palsy; chronic obstructive pulmonary disease; congestive heart failure; erectile dysfunction; foot drop in cerebral palsy, stroke, and other indications; general muscle strengthening in healthy individuals; improving ambulatory function and muscle strength for progressive diseases (e.g., cancer, chronic heart failure, chronic obstructive pulmonary disease, multiple sclerosis) in persons without spinal cord injury; improvement of functional capacity and quality of life after cardiac surgery; masseter muscle oral dysfunction after stroke; muscle atrophy after stroke; pain caused by necrosis of the femoral head; treatment of denervated muscles; treatment of knee osteoarthritis; upper extremity hemiplegia.

Wearable NMES devices (e.g., geko T-3 and geko W-3) for enhancement of blood circulation/microcirculation, reduction of edema, and prevention of venous thrombosis in the lower limb with venous insufficiency and/or ischemia.

Coding Guidance

Covered CPT codes (FES for spinal cord injury when selection criteria met)CPTCovered

63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural.
63685	Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling.
64555	Percutaneous implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve).
64575	Incision for implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve).
64585	Revision or removal of peripheral neurostimulator electrodes.
64590	Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling.
64595	Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver.

Other CPT codes neutralCPT

33016-33999

Heart and pericardium (range referenced).

Covered HCPCS codes (FES/NMES supplies and systems)HCPCSCovered

A4556	Electrodes (e.g., apnea monitor), per pair.
A4557	Lead wires (e.g., apnea monitor), per pair.
A4558	Conductive gel or paste, for use with electrical device (e.g., TENS, NMES), per oz.
A4595	Electrical stimulator supplies, 2 lead, per month (e.g., TENS, NMES).
E0731	Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient's skin by layers of fabric).
E0745	Neuromuscular stimulator, electronic shock unit.
E0762	Transcutaneous electrical joint stimulation device system, includes all accessories.
E0764	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.
E0770	Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified.
L8680	Implantable neurostimulator electrode, each.

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Covered CPT codes (NMES)CPTCovered

64550	Application of surface (transcutaneous) neurostimulator.
64565	Percutaneous implantation of neurostimulator electrodes; neuromuscular.
64580	Incision for implantation of neurostimulator electrodes; neuromuscular.

Diaphragmatic/phrenic pacing CPT codes (covered when criteria met)CPTCovered

33277	Insertion of phrenic nerve stimulator transvenous sensing lead.
33278	Removal of phrenic nerve stimulator, including vessel catheterization, imaging guidance, interrogation and programming; system including pulse generator and lead(s).
33279	Transvenous stimulation or sensing lead(s) only.
33280	Pulse generator only.
33281	Repositioning of phrenic nerve stimulator transvenous lead(s).
33287	Removal and replacement of phrenic nerve stimulator; pulse generator.
33288	Transvenous stimulation or sensing lead(s).
64580	Incision for implantation of neurostimulator electrodes; neuromuscular.
93150	Therapy activation of implanted phrenic nerve stimulator system, including interrogation and programming.
93151	Interrogation and programming (minimum one parameter) of implanted phrenic nerve stimulator system.

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Remede System (central sleep apnea) CPT/HCPCS (covered when criteria met)mixedCovered

0424T-0427T	Insertion or replacement of neurostimulator system for treatment of central sleep apnea (T-codes range).
C1823	Generator, neurostimulator (implantable), non-rechargeable, with transvenous sensing and stimulation leads.

Covered CPT codes (Electrical stimulation of sacral anterior roots)CPTCovered

63185	Laminectomy with rhizotomy; one or two segments.
63190	Laminectomy with rhizotomy; more than two segments.
63655	Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural.
64561	Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed.
64581	Incision for implantation of neurostimulator electrode array; sacral nerve (transforaminal placement).

HCPCS related to sacral anterior roots (covered when criteria met)HCPCSCovered

A4290	Sacral nerve stimulation test lead, each.
E0745	Neuromuscular stimulator, electronic shock unit.
L8680	Implantable neurostimulator electrode, each.
L8681	Patient programmer (external) for use with implantable programmable neurostimulator pulse generator.
L8682	Implantable neurostimulator radiofrequency receiver.
L8684	Radiofrequency transmitter (external) for use with implantable sacral root neurostimulator receiver for bowel and bladder management, replacement.
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension.
L8686	Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension.
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension.
L8688	Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension.

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Form-fitting conductive garment HCPCS (covered when criteria met)HCPCSCovered

E0731

Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient's skin by layers of fabric).

Billing and authorization constraints: providers must document that ALL applicable selection criteria are met to obtain prior authorization for FES/NMES implantable systems (examples include codes E0764, E0770, 63655, 64555 for Parastep I and similar systems). Replacement of implanted FES or diaphragmatic/phrenic systems requires documentation that the original device met medical necessity and is no longer under warranty (codes such as E0764, E0745, L8685/L8686). NMES for disuse atrophy requires documentation of intact nerve supply and non-neurological cause plus prior failure of physical therapy when required (billable codes include 64550, E0745, A4595). Billing rule: do not bill for more than 2 hours of NMES within any 24-hour period (codes commonly involved include A4595, E0745). Many device and supply HCPCS/CPT groups (implantable leads/generators, functional stimulator systems, and supply codes) are listed in the policy as commonly subject to prior authorization/documentation requirements.

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Medical necessity documentation for FES

Providers must document that ALL FES selection criteria are met to support coverage for Parastep I System. Required documentation should confirm intact lower motor units (L1 and below), successful completion of a training program of at least 32 physical therapy sessions over a 3-month period, the member’s ability to transfer independently and stand for at least 3 minutes, and absence of any listed contraindications (cardiac pacemaker, severe scoliosis or severe osteoporosis, skin disease or cancer at stimulation site, irreversible contracture, autonomic dysreflexia). Affected codes: E0764, E0770, 63655, 64555.

Affected codes: E0764, E0770, 63655, 64555
Document intact lower motor units (L1 and below)
Document completion of ≥32 PT training sessions with device over a 3-month period
Document ability to transfer independently and stand ≥3 minutes
Document absence of contraindications listed (pacemaker; severe scoliosis or osteoporosis; skin disease/cancer at stimulation site; irreversible contracture; autonomic dysreflexia)

Prior Authorization

Clinical Background & Evidence Overview

Background (brief): Spinal cord injury (SCI) severity is classified by the ASIA Impairment Scale (A–E) based on motor and sensory function including sacral segments; SCI may involve upper motor neuron (UMN) and/or lower motor neuron (LMN) damage, with implications for responsiveness to electrical stimulation. FES (a form of NMES) delivers patterned electrical impulses to motor nerves to generate functional movements; the Parastep I System is a transcutaneous, micro-computerized FES system controlled from a walker hand-bar that triggers peripheral nerves to enable standing and short-distance ambulation. Evidence and experience show variable ambulatory benefit: training programs (at least 32 sessions) can enable standing and short ambulation with high inter-individual variability and reports of many users achieving at least 30 feet of ambulation. Distinctions: members must have intact lower motor units and peripheral nerve–muscle connectivity (L1 and below) for FES ambulation candidacy, unlike UMN-predominant impairments where some FES applications may be less effective. Other FES applications described include diaphragmatic/phrenic pacing (implantation of electrodes on phrenic nerves and implanted stimulator to condition and stimulate the diaphragm) for ventilator-dependent SCI, central alveolar hypoventilation, and selected ALS patients — requiring viable phrenic nerves, adequate diaphragm/lung function, and ability to achieve at least 4 continuous hours/day of ventilator-independent breathing — and sacral anterior root stimulation (Vocare/Brindley) with posterior rhizotomy for selected complete supra-sacral SCI patients meeting timing and cystometry/reflex thresholds for restoration of voiding on demand.

Study / Source	Key finding / metric
Klose et al (1997) — Parastep I training study	32 training sessions enabled standing and short-distance ambulation in thoracic motor-complete SCI; high inter-individual variability
Graupe & Kohn (1998) — Parastep I usage series	Reported ~400 users; essentially all achieved standing and ≥30 ft ambulation (some up to 1 mile)
Onders et al — DPS multi-center experience (2000–2007)	88 implanted (50 SCI, 38 ALS); 96% SCI patients replaced mechanical ventilation; no perioperative mortality reported
Remede System pivotal RCT (Costanzo et al., Lancet 2016)	RCT n=151: 51% treatment vs 11% control achieved ≥50% AHI reduction at 6 months; 91% had no related serious AEs at 12 months
Meta-analyses of FES for foot drop in MS (Miller et al. 2017; Springer 2017)	Meta-analysis (19 studies, 490 pts): short-walk orthotic effect +0.05–0.08 m/s; no therapeutic effect on long-walk tests
FES vs AFO RCTs (Sheffler 2006; Kluding 2013; Everaert 2013; Bethoux 2014)	Multiple RCTs show FES often equivalent to AFO for gait speed and function; sometimes higher user satisfaction with FES
NMES in COPD (Maddocks et al. 2017; Chen et al. 2016)	RCT (n=52): 6-week 6MWT +29.9 m vs placebo −5.7 m (MD 35.7 m, p=0.005); meta-analysis (9 trials, n=276) showed improved quadriceps strength (SMD 1.12) and exercise distance (WMD ~51.5 m)
Knee rehabilitation (Kneehab vs Polystim) — Feil et al. 2011	Kneehab group: extensor strength +27.8–30.2% at 6 months; single-leg hop +50% between 6wk–6mo; significant Lysholm improvement vs control/Polystim
Stroke NMES/FES evidence syntheses (Pereira 2012; Eraifej 2017)	Pooled RCTs (chronic stroke) small but significant effect on 6MWT (SMD 0.379; p=0.013); upper-limb FES evidence low-quality/heterogeneous
NMES for post-stroke dysphagia (Wang 2023 meta-analysis)	46 RCTs (3,346 pts): NMES + standard therapy improved multiple swallowing measures (e.g., PAS MD −0.63; FOIS MD +1.32); safety/long-term data limited

Definitions

Term	Definition
ASIA Impairment Scale	Classification system describing extent of spinal cord injury from A (complete) to E (normal) based on motor and sensory function including sacral segments S4-S5.
Diaphragmatic/phrenic pacing (DPS)	Surgically implanted electrodes on phrenic nerves connected to an implanted stimulator to condition and stimulate the diaphragm for ventilatory support.
Transurethral electrical bladder stimulation (TEBS)	A procedure involving bladder filling and transurethral electrode stimulation intended to restore detrusor contractility via repeated sessions.
NESS H200 / Handmaster	Upper extremity neuroprosthesis that applies surface electrical stimulation via a custom orthosis to produce functional hand movements.
TEBS	Transurethral electrical bladder stimulation
NMES	Neuromuscular electrical stimulation — electrical stimulation to elicit muscle contraction for training/rehabilitation.
FES	Functional electrical stimulation — device-based application of electrical stimulation to restore or produce functional movements.
AFO	Ankle-foot orthosis — an orthotic device for ankle/foot support.
Threshold Electrical Stimulation (TES)	Low-intensity electrical stimulation, usually at night, intended to strengthen muscles weakened by non-use and increase joint mobility.
FES (functional) — duplicate term	Application of electrical stimulation to motor nerves to generate muscle contractions to produce functional movements (e.g., for foot drop).
NMES (neuromuscular) — duplicate term	Surface or implanted electrical stimulation applied to muscles to produce contraction for strengthening or re-education.
SNS/SNM	Sacral nerve stimulation / sacral neuromodulation — implantable stimulation of sacral nerve roots for fecal incontinence/constipation and related pelvic disorders.
PNS	Phrenic nerve stimulation — stimulation of phrenic nerve/diaphragm for central sleep apnea or ventilator weaning.
DP	Diaphragm pacing — implantation of intramuscular electrodes in hemi-diaphragm for stimulation to restore diaphragmatic function.
TAPS	Transcutaneous afferent patterned stimulation — patterned peripheral nerve stimulation therapy used by Cala Trio for essential tremor.
geko	Wearable NMES devices (T-3, W-3) that stimulate common peroneal nerve to activate calf muscle pump for enhanced blood flow.
Functional Electrical Stimulation (general) — definition	Application of electrical current to produce functional movement, e.g., to correct foot drop.
Neuromuscular Electrical Stimulation (general) — definition	Application of electrical stimulation to elicit muscle contraction, often for strengthening, pain, or rehabilitation.
Transcutaneous afferent patterned stimulation (full)	Noninvasive, wrist-worn neuromodulation targeting median and radial sensory afferents at tremor frequency to reduce essential tremor.
Phrenic nerve stimulation (alternative label)	Synonymous with diaphragmatic/phrenic pacing; stimulation of phrenic nerve/diaphragm for central sleep apnea or ventilator weaning.
Neuromuscular electrical stimulation — alternate phrasing	Surface or implanted stimulation to elicit muscle contraction for strengthening, re-education, or functional assistance.
Functional neuromuscular stimulator (device class)	Devices for transcutaneous stimulation of muscles of ambulation with computer control (e.g., Parastep/other FES ambulation systems).

Medicare Determinations

No results

Revision History

2004-02-06effective

Policy effective date (Functional Electrical Stimulation and Neuromuscular Electrical Stimulation).

2024-02-27last_reviewLatest

Policy last review date.

S14.0XXA	Injury of nerves and spinal cord at neck level, initial encounter
S14.159A	Other and unspecified injuries of nerves and spinal cord at neck level, initial encounter
S24.0XXA	Injury of nerves and spinal cord at thorax level, initial encounter
S24.159A	Other and unspecified injuries of nerves and spinal cord at thorax level, initial encounter
S34.01X	Injury of nerve root at lumbosacral plexus level
S34.129A	Other specified injuries of spinal cord at lumbosacral level, initial encounter
S12.000A	Fracture of cervical vertebra, unspecified, initial encounter
S12.391A	Other fracture of C3-C7 vertebra, initial encounter
S14.101A	Injury of nerve root of neck, initial encounter
S14.154A	Injury of other specified nerve of neck, initial encounter

A4595	Electrode, non-fixed, any type, per pair
E0745	Neuromuscular stimulator, electronic shock unit
E0766	Transcutaneous electrical nerve stimulator (TENS) device for use with chronic pain