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)

Replacement authorization

Replacement of implanted FES or diaphragmatic/phrenic stimulation systems requires documentation that the original device met medical necessity criteria and that the original device is no longer under warranty and cannot be repaired. Affected codes include E0764, E0745, L8685, L8686.

• Affected codes: E0764, E0745, L8685, L8686
• Document original device met applicable medical necessity criteria
• Document device is no longer under warranty and is not repairable

NMES for disuse atrophy

For NMES to treat disuse atrophy, document that the nerve supply to the target muscle is intact and that a specific non‑neurological reason for disuse atrophy is present (e.g., contracture from burn scarring, major knee surgery with PT failure, prior casting/splinting with PT failure, or recent hip replacement prior to PT). Where required, document prior failure to respond to physical therapy.

• Affected codes: 64550, E0745, A4595
• Document intact nerve supply to the muscle
• Document the non-neurological cause of disuse atrophy
• Document prior failure to respond to physical therapy when applicable

NMES daily usage limit

Billing for NMES supplies/devices should reflect that more than 2 hours of NMES within a 24‑hour period is considered not medically necessary. Providers should not bill for NMES use exceeding this threshold.

• Affected codes: A4595, E0745
• Usage threshold: ≤ 2 hours per 24‑hour period; >2 hours/24 hr is not medically necessary

Vocare Bladder System selection documentation

Document patient selection criteria for the Vocare Bladder System (sacral anterior root stimulation with posterior rhizotomy): ASIA classification indicating clinically complete supra‑sacral lesion with intact parasympathetic innervation of the bladder; timing since injury (≥3 months for females, ≥9 months for males after complete supra‑sacral SCI); cystometry demonstrating a phasic detrusor pressure rise meeting thresholds (≥35 mm H2O female, ≥50 cm H2O male); and presence of at least 3 of 4 non‑vesical sacral segment reflexes (ankle jerks, bulbo‑cavernous reflex, anal skin reflex, reflex erection).

• Affected codes: 63185, 63190, 64561
• Document ASIA classification and clinically complete supra‑sacral lesion with intact parasympathetic innervation
• Document timing since injury: ≥3 months (female) or ≥9 months (male)
• Document cystometry detrusor pressure thresholds: ≥35 mm H2O (female) or ≥50 cm H2O (male)
• Document presence of ≥3 of 4 non‑vesical sacral reflexes (ankle jerks, bulbo‑cavernous, anal skin reflex, reflex erection)

Remede System prior therapy failure

Prior to coverage for the Remede System (phrenic nerve stimulation for central sleep apnea), document that the patient has failed supplemental oxygen therapy, pharmacotherapy (e.g., acetazolamide or theophylline), and mask‑based therapies such as CPAP or BiPAP.

• Affected codes: 0424T-0427T, C1823
• Document failure of supplemental oxygen therapy
• Document failure of pharmacotherapy (e.g., acetazolamide, theophylline)
• Document failure of mask-based therapies (CPAP, BiPAP)

Diaphragmatic pacing candidate evaluation

Document evaluation of candidacy for diaphragmatic (phrenic) pacing: evidence of viable phrenic nerves, adequate diaphragm and lung function, and that the patient is stable and out of the acute phase. Mapping (motor point mapping) and intraoperative testing/mapping are recommended as part of the evaluation and implantation process.

• Viability requirements: viable phrenic nerves and diaphragm movement with stimulation
• Adequate diaphragm and lung function to permit at least 4 continuous hours off mechanical ventilation when indicated
• Patient stability: out of the acute phase of injury
• Recommendation: laparoscopic motor point mapping and intraoperative mapping/testing prior to implantation

Vocare/Brindley patient selection and testing

Before implantation of Vocare/Brindley systems, perform pre‑implant cystometry and reflex testing to assess bladder emptying potential. Success criteria post‑implant are defined as the ability to void more than 200 ml on demand with post‑void residual (PVR) <50 ml.

• Affected codes: 63185, 63190, 64561
• Perform pre-implant cystometry to assess detrusor contractility
• Assess non‑vesical sacral reflexes (require presence of 3 of 4)
• Success thresholds: ability to void >200 ml on demand and PVR <50 ml post‑implant