Indications and Limitations of Coverage and/or Medical Necessity
FOR CLAIMS PRIOR TO 9/1/2010, the following indications and limitations apply:
Posterior tibial nerve stimulation (PTNS) services billed to Medicare will be denied as not medically necessary. PTNS for urinary dysfunction, including but not limited to urinary frequency, urgency, incontinence and retention, is considered investigational and is not covered under Medicare.
Posterior tibial nerve stimulation is a technique of electrical neuromodulation for the treatment of voiding dysfunction in patients who have failed behavioral and/or pharmacologic therapies. Voiding dysfunction includes urinary frequency, urgency, incontinence, and non-obstructive retention. Common causes of voiding dysfunction are pelvic floor dysfunction (from pregnancy, childbirth, surgery, etc.), inflammation, medication (e.g., diuretics and anticholinergics), obesity, psychogenic factors, and disease (e.g., multiple sclerosis, spinal cord injury, detrusor hyperreflexia, diabetes with peripheral nerve involvement, etc.). Altering the function of the posterior tibial nerve with PTNS is believed to improve voiding function and control. While the posterior tibial nerve is located near the ankle, it is derived from the lumbarsacral nerves (L4-S3), which control the bladder detrusor and perineal floor.
The procedure for PTNS consists of the insertion of a needle above the medial malleolus into the posterior tibial nerve followed by the application of low voltage (10mA, 1-10 Hz frequency) electrical stimulation that produces sensory and motor responses (i.e., a tickling sensation and plantar flexion or fanning of all toes). Noninvasive PTNS has also been delivered with surface electrodes. PTNS studies have reported on 30-minute sessions given weekly for 10-12 weeks. Recently, consideration has been given to increasing the frequency of treatments to 3 times per week to speed achievement of desired outcomes. However, an optimal treatment approach has not been identified and the durability of PTNS is uncertain.
In July 2005, the UrgentŪ PC Neuromodulation System (Uroplasty, Inc.) received 510(k) marketing clearance for percutaneous tibial nerve stimulation to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence. This device was cleared as a class II ''nonimplanted, peripheral nerve stimulator for pelvic floor dysfunction" because it was considered to be substantially equivalent to the previously cleared percutaneous Stoller afferent nerve system (PerQ SANS System) in 2001 (K992069, UroSurge, Inc.).
PTNS was developed as a less-invasive treatment alternative to traditional sacral root neuromodulation which has been successfully used in the treatment of urinary dysfunction, but requires implantation of a permanent device. In sacral root neuromodulation, an implantable pulse generator that delivers controlled electrical impulses is attached to wire leads that connect to the sacral nerves, most commonly the S3 nerve root that modulates the neural pathways controlling bladder function.
Note: Stimulation of the sacral nerve as a treatment of incontinence is discussed separately in a National Coverage Decision, Pub 100-3, Chapter 1, Part 4, section 230.18.
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.
Study selection criteria used in the 1996 TEC Assessment on percutaneous electrical nerve stimulation (PENS) can be applied for the evaluation of evidence on PTNS:
22 The study contained original empirical data;
22 The study design included a treatment group and a control group;
22 The study reported on a health outcome relevant to the condition treated; and
22 The study used a random assignment, control group design.
The literature search revealed no randomized trials meeting the above criteria. Evidence from clinical series tends to overestimate treatment effect. These studies do not account for placebo effects or for dropouts by using intent-to-treat analysis. Randomized controlled clinical trials are needed to control for the effects of bias and to demonstrate the efficacy of PTNS.
Several clinical studies have reported on the use of PTNS with some favorable outcomes, including reductions in urinary frequency and urgency. However, no randomized, controlled trials have been published comparing PTNS to placebo or other voiding dysfunction treatments. In a prospective observational study, Nuhoglu et al. treated 35 patients with overactive bladder with 10 weekly 30-minute sessions using the UroSurge device.
1) Nineteen patients (54%) experienced significant reductions in urinary urgency and increases in urine volume after therapy. However, these effects were maintained in only 8 patients (23%) after 1 year. In a small study of 11 patients, van der Pal and colleagues also found limited durability of PTNS treatment effects as increases in incontinence and/or voiding frequency occurred in 50% or more patients 6 weeks after treatment.
2) When treatment was resumed, the incontinence and/or voiding frequency decreased 50% or more. While these studies are small, the effects of PTNS appear to be short term. And, as the van der Pal authors indicate, continuous PTNS may be necessary. Finally, Finazzi and colleagues found no differences in outcomes in 35 patients randomized to PTNS weekly versus 3 times per week.
3) The authors noted patients in both treatment groups had subjective improvements after 6-8 sessions of PTNS suggesting more frequent treatment initially may result in earlier achievement of desired effects even though the frequency of PTNS did not influence the final outcomes in this study.
In conclusion, randomized trials with appropriate control groups are needed to determine the durability and short- and long-term effects of PTNS on voiding dysfunction. Additionally, further randomized trials to determine appropriate treatment periodicity are needed.
A search of the MEDLINE database for the period of July 2006 through July 2007 did not identify any studies that would alter the conclusions reached above. Van der Pal and colleagues published an analysis of quality of life questionnaires from 29 patients who were treated with PTNS (3 times a week for 4 weeks) for urge urinary incontinence. Information from Figure 1 of the article indicates that at least 12 of the subjects had either no change or an increase in the number of pads used. The authors report that they are currently conducting a randomized double-blind placebo-controlled trial. Another study assessed the efficacy of 12 weeks (1 time/week) of PTNS in 15 patients with chronic pelvic pain in an open prospective clinical trial. The study found subjective improvements in VAS pain scores (8.1 to 4.1) and VAS urgency (4.5 to 2.7), with no change in the number of voids or bladder volume. Since these subjective improvements may be due to placebo, double-blinded controlled trials are needed. In addition, since questions remain about the long-term efficacy of PTNS, longer follow-up will be needed to evaluate this procedure.
FOR CLAIMS OF 9/1/2010 AND THEREAFTER, the following indication and limitation applies:
On 8/5/2010, a formal reconsideration of the LCD was made. Additional literature was submitted (see sources). A study reported in the Journal of Urology, April 2010, conducted PTNS vs sham procedure. Although there was a 20% improvement in symptoms in the sham arm of the study, an additional 35% improvement occurred with PTNS treatment with a 12 week treatment regimen. A study submitted compared a 12 week treatment of PTNS vs oral medication. This was considered at least as safe and effective. Additional literature was submitted for q 3 week treatment for up to one year. This treatment followed a 12 week regimen. This is viewed as a maintenance program and would not be covered. At this time Pinnacle Medicare Services is changing the LCD to allow a 12 week (13 treatment) regimen for PTNS as a once in a lifetime treatment regimen.
CMS National Coverage Policy:
Title XVIII of the Social Security Act, section 1862(a)(1)(A). This section allows coverage and payment for only those services that are considered to be medically reasonable and necessary.
Title XVIII of the Social Security Act, section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
Title XVIII of the Social Security Act, section 1862(a)(7) excludes routine physical evaluations and screening tests performed in the absence of signs or symptoms from coverage.
1. The correct CPT code to use for PTNS is the unlisted CPT code 64999. CPT codes for percutaneous implantation of neurostimulator electrodes (i.e., 64553-64565) are not appropriate since PTNS uses percutaneously inserted needles and wires rather than percutaneously implanted electrodes. The stimulation devices used in PTNS and PNT are not implanted, so CPT code 64590 is also not appropriate.
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