Posterior Tibial Nerve Stimulation PTNS (L28457)
Contractor Information
|
Contractor Name Wisconsin Physicians Service Insurance Corporation |
Contractor Number 00951, 00952, 00953, 00954, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402 |
Contractor Type Carrier - MAC |
LCD Information
Document Information
|
L28457 LCD Title Posterior Tibial Nerve Stimulation PTNS Contractor's Determination Number GSURG-043 AMA CPT/ADA CDT Copyright Statement CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply. |
Primary Geographic Jurisdiction
Oversight Region Original Determination Effective Date For services performed on or after 02/16/2009 Original Determination Ending Date Revision Effective Date For services performed on or after 01/01/2011 Revision Ending Date |
CMS National Coverage Policy
CMS Publication 100-04 Medicare Claims Processing Manual
Indications and Limitations of Coverage and/or Medical Necessity
Posterior tibial nerve stimulation for urinary dysfunction, including but not limited to urinary frequency, urgency, incontinence and retention, is considered investigational and is not covered under Medicare. Services billed to Medicare will be denied as not medically necessary.
Posterior tibial nerve stimulation (PTNS) 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 nonobstructive 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, 110 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 1012 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.
PTNS is related to acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In PTNS, the location of stimulation is directly in the posterior tibial nerve rather than using the theories of energy flow that guide placement of stimulation for acupuncture. However, the methodology of placement and stimulation of the needles is not based on accurate and definitive location of the posterior tibial nerve, and is based on acupuncture principles.
In July 2005, the Urgent® 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.
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:
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 68 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.
Note: There is no separate policy statement for patients with interstitial cystitis, as they would be considered candidates for PTNS therapy based on the presence of urgency and frequency alone.
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/week for 4 weeks) for urge urinary incontinence (4) 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 doubleblind 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. (5) 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.
Please note that Medicare national regulation currently does not cover acupuncture in any format. Since this procedure is performed with acupuncture needle, even when it is considered to be an effective treatment for PTNS may still may be denied based on the acupuncture regulations.
Posterior tibial nerve stimulation (PTNS) 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 nonobstructive 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, 110 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 1012 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.
PTNS is related to acupuncture with electrical stimulation. In electrical acupuncture, needles are also inserted just below the skin, but the placement of needles is based on specific theories regarding energy flow throughout the human body. In PTNS, the location of stimulation is directly in the posterior tibial nerve rather than using the theories of energy flow that guide placement of stimulation for acupuncture. However, the methodology of placement and stimulation of the needles is not based on accurate and definitive location of the posterior tibial nerve, and is based on acupuncture principles.
In July 2005, the Urgent® 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.
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:
- the study contained original empirical data;
- the study design included a treatment group and a control group;
- the study reported on a health outcome relevant to the condition treated; and
- 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 68 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.
Note: There is no separate policy statement for patients with interstitial cystitis, as they would be considered candidates for PTNS therapy based on the presence of urgency and frequency alone.
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/week for 4 weeks) for urge urinary incontinence (4) 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 doubleblind 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. (5) 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.
Please note that Medicare national regulation currently does not cover acupuncture in any format. Since this procedure is performed with acupuncture needle, even when it is considered to be an effective treatment for PTNS may still may be denied based on the acupuncture regulations.
Coding Information
Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
Revenue Codes:
CPT/HCPCS Codes
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
| 64566 | POSTERIOR TIBIAL NEUROSTIMULATION, PERCUTANEOUS NEEDLE ELECTRODE, SINGLE TREATMENT, INCLUDES PROGRAMMING |
| 97014 | APPLICATION OF A MODALITY TO 1 OR MORE AREAS; ELECTRICAL STIMULATION (UNATTENDED) |
| 97032 | APPLICATION OF A MODALITY TO 1 OR MORE AREAS; ELECTRICAL STIMULATION (MANUAL), EACH 15 MINUTES |
ICD-9 Codes that Support Medical Necessity
| XX000 | Not Applicable |
Diagnoses that Support Medical Necessity
See ICD-9 listed above
ICD-9 Codes that DO NOT Support Medical Necessity
ICD-9 codes not listed in this policy
ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation
Diagnoses that DO NOT Support Medical Necessity
Diagnoses not listed in this policy
General Information
*The correct CPT code to use for PTNS is the unlisted CPT code 64566. 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.
Services provided as components to non-covered services are also not covered.
Appendices
Services provided as components to non-covered services are also not covered.
N/A
Sources of Information and Basis for Decision
Notes
* - An asterisk indicates a revision to that section of the policy.
Nuhoglu B, Fidan V, Ayyildiz A et al.Stoller afferent nerve stimulation in woman with therapy resistant over active bladder; a 1-year follow up. Int Urogynecol J Pelvic Floor Dysfunct 2006; 17(3):204-7.
van der Pal F, van Balken MR, Heesakkers JP et al. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int 2006; 97(3):547-50.
Finazzi Agro E, Campagna A, Sciobica F et al.Posterior tibial nerve stimulation: is the once-aweek protocol the best option? Minerva Urol Nefrol 2005; 57(2):119-23.
van der Pal F, van Balken MR, Heesakkers JP et al. Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int 2006; 97(1):113-6.
Kim SW, Paick JS, Ku JH. Percutaneous posterior tibial nerve stimulation in patients with chronic pelvic pain: a preliminary study. Urol Int 2007; 78(1):58-62.
Advisory Committee Meeting Notes
* - An asterisk indicates a revision to that section of the policy.
Nuhoglu B, Fidan V, Ayyildiz A et al.Stoller afferent nerve stimulation in woman with therapy resistant over active bladder; a 1-year follow up. Int Urogynecol J Pelvic Floor Dysfunct 2006; 17(3):204-7.
van der Pal F, van Balken MR, Heesakkers JP et al. Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary? BJU Int 2006; 97(3):547-50.
Finazzi Agro E, Campagna A, Sciobica F et al.Posterior tibial nerve stimulation: is the once-aweek protocol the best option? Minerva Urol Nefrol 2005; 57(2):119-23.
van der Pal F, van Balken MR, Heesakkers JP et al. Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation. BJU Int 2006; 97(1):113-6.
Kim SW, Paick JS, Ku JH. Percutaneous posterior tibial nerve stimulation in patients with chronic pelvic pain: a preliminary study. Urol Int 2007; 78(1):58-62.
Meeting Date:
Wisconsin: 9/26/2008
Illinois: 9/17/2008
Michigan: 9/24/2008
Minnesota: 9/11/2008
MAC J-5 10/16/2008 and 10/17/2008
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the Illinois, Michigan, Wisconsin and Minnesota Psychiatric Society.
Start Date of Comment Period
Wisconsin: 9/26/2008
Illinois: 9/17/2008
Michigan: 9/24/2008
Minnesota: 9/11/2008
MAC J-5 10/16/2008 and 10/17/2008
This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from the Illinois, Michigan, Wisconsin and Minnesota Psychiatric Society.
10/17/2008
End Date of Comment Period
12/03/2008
Start Date of Notice Period
04/01/2011
Revision History Number
X
Revision History Explanation
Correctly removed contract number 05392 effective 8/1/2009, as it is being combined with contractor number 05302 (WPS Part B MAC Missouri - Entire State.) JS 07/30/09
11/15/2009 - The description for CPT/HCPCS code 97032 was changed in group 1
01/24/2011, reviewed LCD, no updates needed;
04/01/2011, added CPT code 64566 with effective date of 01/01/2011, removed NOC code
Reason for Change
11/15/2009 - The description for CPT/HCPCS code 97032 was changed in group 1
01/24/2011, reviewed LCD, no updates needed;
04/01/2011, added CPT code 64566 with effective date of 01/01/2011, removed NOC code
03/01/2011
Related Documents
This LCD has no Related Documents.
LCD Attachments
NOTE: Should you have landed here as a result of a search engine (or other) link, be advised that these files contain material that is copyrighted by the American Medical Association. You are forbidden to download the files unless you read, agree to, and abide by the provisions of the copyright statement. Read the copyright statement now.
Page Last Updated: Wednesday, 05-Oct-2011 11:26:57 CDT
Home |
Web Help |
Feedback |
About WPS
© Wisconsin Physicians Service Insurance Corporation | All Rights Reserved
Privacy Statement | Legal Disclaimer
