Treatment Funnel & Reimbursement

Patients with Overactive Bladder (OAB) and Neurogenic Bladder (NB) generally experience the following treatment algorithm with their urologist / urogynecologist:

Pharmacological. Drugs are non-invasive, help millions, but come with side effects, especially in higher dosages as the body accommodates to use over time. Medications for overactive bladder (OAB) primarily fall into two categories: anticholinergics and beta-3 adrenergic agonists. Anticholinergics like oxybutynin, tolterodine, solifenacin, and darifenacin block signals to reduce bladder muscle contractions, though they can cause side effects like dry mouth. Beta-3 agonists, such as mirabegron and vibegron, work by relaxing the bladder muscle to increase bladder capacity and may have fewer side effects for some patients. Side effects include dry mouth, blurred vision, constipation, urinary retention, tachycardia (increased heart rate), confusion, memory impairment, drowsiness, and others.
Non-invasive neurostimulation, e.g. TENS applied to the tibial nerve location near the ankle. Helps some patients, but reliable activation of the tibial nerve is often hindered by sufficient current (“electrical signal”) reaching the nerve from the outside of the body. Especially true when leg edema (=swelling of the leg) causes an increase of the distance between the outside of the skin and the tibial nerve inside the leg. Examples are the ZIDA Wearable Neuromodulation System (K192731) and the Avation Medical Vivally system (K220454).
Temporary invasive neurostimulation via needle, placed into or very close to the tibial nerve. Example are the Medtronic NURO system (K132561), the Urgent® PC Neuromodulation System (K101847). Typical use requires patients to visit the clinician for 30 minutes sessions once a week for the duration of two months (initial 8 sessions) followed by monthly to quarterly maintenance visits (4-12 sessions yearly thereafter).
Permanent invasive neurostimulation via surgical open cut of 1-1.5 inch (about 2-4 cm) in length to place a neurostimulator either on the tibial nerve near the ankle or on the lower back connected to a lead wire into the sacral foramen. Examples at the sacral location include the Medtronic InterStim™ and InterStim II® Sacral Nerve Stimulation (SNS) Systems, InterStim™ Micro Rechargeable Sacral Neuromodulation system (PMA P970004 and others) as well as the Axonics Rechargeable Sacral Neuromodulation (r-SNM)® System (PMA P190006 and others) by Boston Scientific. Examples at the tibial location are the Medtronic Altaviva system (PMA P240011), the Bluewind medical Revi system (K240037), and the Valencia Technologies eCoin (P200036). One key difference between the tibial nerve (TN) and the sacral nerve permanent implants is that the tibial nerve systems to not require conducting a trial procedure. The sacral nerve permanent implant procedure generally requires the temporary trial period of 7-10 days prior to placement of the permanent implant, where a patient will have a thin flexible wire placed into one or two sacral foramen connected to a stimulator that is attached to the outside of the lower back of the patient with sticky tape for the 7-10 day duration of trial.

ICD-10 Codes

Treatment Diagnosis codes / ICD-10 codes used in the clinic and by reimbursement / insurance:

  
      ICD-10-CM Diagnosis Code
      Description
    
      N32.81
      Overactive bladder
    
      N39.41
      Urge incontinence
    
      N39.42
      Incontinence without sensory awareness
    
      N39.43
      Post-void dribbling
    
      N39.44
      Nocturnal enuresis
    
      N39.45
      Continuous leakage
    
      N39.46
      Mixed incontinence
    
      N39.490
      Overflow incontinence
    
      N39.491
      Coital incontinence
    
      N39.492
      Postural (urinary) incontinence
    
      N39.498
      Other specified urinary incontinence
    
      R32
      Unspecified urinary incontinence
    
      R33.0
      Drug induced retention of urine
    
      R33.8
      Other retention of urine
    
      R33.9
      Retention of urine, unspecified
    
      R35.0
      Frequency of micturition
    
      R35.81
      Nocturnal polyuria
    
      R35.89
      Other polyuria
    
      R39.14
      Feeling of incomplete bladder emptying
    
      R39.15
      Urgency of urination

Reimbursement*:

Reimbursement codes utilized by clinic, clinician and by payer / insurance:

Sacral Nerve Stimulation

Codes:
- CMS 64561, 64561-50, 64590
- Outpatient - Trial unilateral / bilateral: $6,563
- Outpatient - Permanent implant, system: $21,444
- ASC - Trial unilateral CMS 64561: $5,218
- ASC - Trial bilateral CMS 64561-50: $10,436
- ASC - Permanent Implant CMS 64590: $19,672
Surgery: Requires ~3 to 5 cm (~1-2 inch) incision, then blunt dissection to form pocket for the stimulator intended to be implanted
Placement Location: S2-S4, typically S3
Trial: Peripheral Nerve Evaluation (PNE) lead placed for up 7 to 14 days

Tibial Nerve Stimulation

Codes:
- 0816T - Outpatient $21,063 and ASC $19,464
Surgery: Requires ~3cm (1-1.5 inch) incision, then open dissection to the tibial
nerve to be able to suture implant to the surrounding tissue using the
anchoring openings provided in the silicone suture wings.

*The reimbursement information, including CPT®, HCPCS, and CMS codes, coverage levels, and related policies, is provided for general informational purposes only. While we have made efforts to compile accurate information from publicly available sources (including CMS, FDA, and medical device manufacturer websites), coding, coverage, and payment policies are subject to change without notice. This information does not constitute legal, financial, billing, or reimbursement advice. Users are responsible for verifying coding, coverage, and payment information with the appropriate payers and should consult with their own reimbursement, compliance, or legal advisors regarding any specific questions. We make no representation, warranty, or guarantee that use of the information provided will result in coverage or payment.