Posterior Tibial Nerve Stimulation Coverage - JF Part B

Effective July 1, 2016

Posterior Tibial Nerve Stimulation (PTNS) is a minimally invasive neuromodulation system designed to deliver retrograde electrical stimulation to the sacral nerve plexus through percutaneous electrical stimulation of the posterior tibial nerve. Noridian has determined that PTNS will be covered for treatment of urinary urgency, urinary frequency, and urge incontinence. This article does not address the following NCD: CMS Internet Only Manual (IOM), Publication 100-03, Medicare National Coverage Determination (NCD) Manual, Section 230.16 - Bladder Stimulators (Pacemakers). Noridian covers Sacral Nerve Stimulation with restrictions in a separate coverage article.

PTNS Procedure Description

The posterior tibial nerve contains mixed sensory motor nerve fibers that originate from L4 through S3, which modulate the innervation to the bladder, urinary sphincter and pelvic floor. The specific mechanism of action of neuromodulation is unclear, although theories include improved blood flow and change in neurochemical balance along the neurons. Neuromodulation may have a direct effect on the detrusor or a central effect on the micturition centers of the brain.

Using a battery-powered, handheld stimulator and a 34-gauge needle electrode, one can access and stimulate the tibial nerve. Patients receive one 30-minute weekly treatment in the office for 12 weeks. Patients treated with PTNS may begin to see changes in their voiding patterns after four to six treatments, with nocturia and urge incontinence decreases usually reported first. Patients who respond to the treatment require additional therapy at individually-defined treatment intervals for sustained relief of symptoms.

Coverage Guidelines

Consistent with Noridian, manufacturer instructions, and existing literature descriptions of appropriate clinical usage, Noridian expects this treatment to be (generally) delivered in an office setting (Place of Service 11) and that the standard treatment regimen will consist of one 30-minute sessions given once weekly for 12 weeks.

Coverage for initial therapy must document failed standard anticholinergic drug therapy or that the patient demonstrates intolerance to the anticholinergic drug therapy despite best attempts at management of the most common side effects of such therapy, such as dry mouth and constipation.

Coverage for maintenance therapy on an every-three-weeks basis for up to two years can be extended for a longer time to patients who demonstrate significant improvement in overactive bladder (OAB) symptoms at the end of the standard 12-week course of therapy. Documentation must support the initial improvement and the need for the additional treatments.

Bill no more than three Evaluation and Management (E&M) services during any initial course of PTNS treatment:

1. On the initial visit;
2. At the 5th or 6th visit to assess progress; and
3. At the end of the initial 12-week course of therapy.

The patient's medical record must contain adequate documentation identifying the CPT® and ICD-10-CM coding, and the need for and level of these visits. Noridian reminds the provider community that this coverage decision may be modified or terminated depending upon future literature or clinical experience and usage.

Revision History