Vivally System (E0737) Supporting Medical Records
Documentation commonly needed to support medical necessity for Vivally (E0737).
1. Diagnosis & Symptoms (Symptoms should be quantified when possible)
- Overactive Bladder (OAB)
- Urgency Urinary Incontinence (UUI)
- Urinary urgency/frequency
- Nocturia
- Functional impairment and quality of life impact
Example: “Patient reports urinary urgency and frequency occurring throughout the day with nocturia and urge incontinence. Symptoms disrupt sleep and daily activities.”
2. Conservative Therapy History
Prior conservative measures (include timing, duration and clinical response)
- Timed voiding
- Fluid management
- Bladder irritant reduction
- Pelvic floor exercises
- Urge suppression techniques
Example: “Patient completed behavioral therapy over several weeks without meaningful symptom improvement.”
3. Medication Trials
Include:
- Medication name
- Dose and duration
- Treatment response
- Side effects or reason discontinued
Example: “Patient trialed pharmacologic therapy at therapeutic dose and duration without clinically meaningful improvement.”
4. Medical Necessity Rationale
The record should explain why escalation of therapy is clinically appropriate.
Example: “Given persistent symptoms despite conservative and pharmacologic therapy, non-invasive neuromodulation represents a medically reasonable next-step treatment option.”
5. Optional Supporting Documentation
When available, consider including:
- Voiding diary
- Pad counts
- Symptom questionnaires
Voiding Diary – Including a completed 3-day voiding diary may provide additional objective support for symptom severity and functional impact. Please refer to a sample diary from AUA.