Document FES eligibility criteria for SCI patients

For spinal cord injury (SCI) patients being considered for functional electrical stimulation (FES), document that all eligibility criteria are met. Provide clear objective findings, functional abilities, and timelines to support medical necessity for FES as part of a comprehensive ambulation rehabilitation program.

• Intact lower motor units at L1 and below (both muscle and peripheral nerves) with documentation of testing used to confirm (e.g., EMG, clinical exam).
• Muscle and joint stability sufficient for weight bearing in upper and lower extremities with objective notes on balance and postural control.
• Demonstration of brisk muscle contraction of target muscles (documented by clinician observation or testing).
• Sufficient sensory perception to permit muscle contraction (documented sensory exam results).
• Evidence of high motivation, commitment, and cognitive ability to use the device (e.g., rehab progress notes, patient-reported goals).
• Ability to transfer independently (documented transfers observed in therapy notes).
• Tolerance of independent standing for at least 3 minutes (documented observation).
• Hand and finger function adequate to manipulate device controls (documented dexterity assessment).
• At least 6 months post-recovery from SCI and any restorative surgery (date of injury/surgery and current date documented).
• Absence of hip and knee degenerative disease (clinical/imaging documentation).
• Absence of history of long-bone fracture secondary to osteoporosis (relevant history or imaging).

Document NMES indications and nerve integrity

When using neuromuscular electrical stimulation (NMES), document the specific indication and objective evidence regarding nerve integrity and the nature of muscle atrophy. Show that NMES is being used within a comprehensive rehabilitation program when applicable.

• Indication for NMES (e.g., disuse muscle atrophy, post–total knee arthroplasty rehabilitation, upper extremity function after stroke) with supporting clinical rationale.
• Documentation that the nerve supply to the affected muscle is intact (clinical exam or diagnostic testing such as EMG).
• Documentation that disuse muscle atrophy is non-neurologic in origin (e.g., due to casting, immobilization, contracture) when applicable.
• Evidence that NMES is part of a comprehensive rehabilitation program (therapy plan, frequency/duration of sessions, multidisciplinary notes).

Use special arrangements for NMES for dysphagia per NICE

For NMES use to treat dysphagia, follow NICE-style special arrangements: document governance, consent, and either audit participation or research oversight to support use when evidence is limited.

• Clinical governance arrangements in place for the use of NMES for dysphagia (local protocol or oversight committee).
• Informed consent documenting explanation of limited evidence and possible risks/benefits.
• Participation in audit or formal research evaluating outcomes of NMES for dysphagia, or documentation of planned data collection for local audit.

Use FDA product code and device-specific indications for coverage assessment

Verify device regulatory status and use the FDA product code and device-specific indications when assessing coverage. Note whether a device has PMA or De Novo authorization and reference examples when applicable.

• Confirm FDA regulatory pathway and product code for the device being requested (PMA, De Novo, 510(k), or not FDA-cleared).
• Document device-specific intended use and indications in support of medical necessity assessment.
• Examples to reference when assessing regulatory status: ReActiv8 (restorative neurostimulation) and PoNS (translingual neurostimulation) as PMA/De Novo–type examples.

Evidence-based medical necessity documentation; Limitations, benefit plan reference, and Medicare Advantage guidance

Provide evidence-based documentation supporting medical necessity and clearly cite limitations of the evidence when relevant. Reference the member's specific benefit plan and follow any Medicare Advantage local guidance for prior authorization when applicable.

• Summarize key supporting clinical evidence in the chart when used to justify coverage, including study design limitations and applicability to the member (e.g., population differences, small sample size, short follow-up).
• If evidence is limited or mixed, document consideration of trial limitations in clinical decision-making and rationale for treatment despite limitations.
• Reference the member-specific benefit plan to confirm coverage terms, exclusions, or required benefit criteria; include plan name/ID and relevant benefit language or authorization requirements.
• For Medicare Advantage members, follow local plan-specific prior authorization procedures and document prior authorization number or evidence of submission when required.
• When prior authorization is required by the payer or plan, include all requested documentation (clinical notes, therapy plans, prior conservative treatments, diagnostic testing) to support the request.

Medicare Advantage local guidance (prior_auth)

Medicare Advantage members may be subject to local plan rules and prior authorization processes; follow those requirements and document compliance.

• Check and follow Medicare Advantage local medical review policies and prior authorization requirements specific to the plan and service.
• Include prior authorization identifiers and correspondence in the medical record when authorization was obtained.
• If denied by local Medicare Advantage guidance, document the rationale and any appeals or alternative treatment plans discussed with the member.