Retired Local Coverage Determination (LCD)

Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control

L33443

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
Retired

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33443
Original ICD-9 LCD ID
Not Applicable
LCD Title
Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/24/2019
Revision Ending Date
07/11/2023
Retirement Date
07/11/2023
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for items and services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 CFR §411.15(k)(1) excluded services that are not reasonable and necessary

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §230.16 Bladder Stimulators (Pacemakers)

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Posterior Tibial Nerve Stimulation (PTNS), a minimally invasive procedure, consists of insertion of an acupuncture needle above the medial malleolus into a superficial branch of the posterior tibial nerve. An adjustable low voltage electrical impulse (10mA, 1-10 Hz frequency) travels via the posterior tibial nerve to the sacral nerve plexus to alter pelvic floor function by neuromodulation.

Treatment regimens consist of 30-minute weekly sessions for 12 weeks. Studies demonstrate that PTNS is safe with statistically significant improvements in patient assessment of overactive bladder (OAB) symptoms (frequency, nocturia, urgency and urge incontinence) and may be considered a clinically significant alternative to pharmacotherapy.

Patients with the improved OAB symptoms of frequency, nocturia, urgency, voided volume and urge incontinence episodes, after the initial 12 sessions, will be allowed at a frequency of 1 treatment every 1-2 months when medical necessity is supported by documentation in the medical record for a maximum of 3 years.  The maximum lifetime number of sessions will be 45 total. Subsequent treatments will not be covered.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

The medical record must indicate the patient has the cognitive ability to navigate to appropriate facilities for voiding.

Utilization Guidelines

The medical record must document at least 1 of the following criteria:

  • Patient failed treatment with 2 anticholinergic drugs, each taken for at least 4 weeks duration, prior to the PTNS therapy initiation.

  • Patient intolerance to anticholinergic drug therapy. To validate intolerance, the medical record must document the specific medical management used to address dry mouth and constipation, the most common side effects of this therapy.

There is no evidence to support continued PTNS therapy after 2 years of treatment at this time.

Sources of Information
N/A
Bibliography

Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. Journal of Urology. 2012;188(6 Suppl):2455-2466.

MacDiarmid SA, Peters KM, Shobeiri SA, et al. Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. Journal of Urology. 2010;183(1):234-240.

Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: Results from the SUmiT trial. Journal of Urology. 2010;183(4):1438-1443.

Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: Results from the overactive bladder innovative therapy trial. Journal of Urology. 2009;182(3):1055-1061.

Peters KM, Carrico DJ, MacDiarmid SA, et al. Sustained therapeutic effects of percutaneous tibial nerve stimulation: 24-month results of the STEP study. Neurourology and Urodynamics. 2013;32(1):24-29.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
07/11/2023 R13

This LCD is being retired due to accepted standards of practice which have rendered this policy ineffective.

  • LCD Being Retired
10/24/2019 R12

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control A56719 article. Punctuation and typographical errors were corrected throughout the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
07/25/2019 R11

All coding located in the Coding Information section has been moved into the related Billing and Coding: Posterior Tibial Nerve Stimulation (PTNS) for Urinary Control A56719 article and removed from the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
05/02/2019 R10

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. CPT® was inserted throughout the LCD where applicable.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
06/01/2018 R9

Under ICD-10 Codes that Support Medical Necessity added ICD-10 code N32.81.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
05/03/2018 R8

Under Bibliography revisions were made to the sources to reflect AMA citation guidelines.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Provider Education/Guidance
02/26/2018 R7 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
11/30/2017 R6

Under Coverage Indications, Limitations and/or Medical Necessity revised the verbiage in the third paragraph to read “Patients with the improved OAB symptoms of frequency, nocturia, urgency, voided volume and urge incontinence episodes, after the initial 12 sessions, will be allowed at a frequency of 1 treatment every 1-2 months when medical necessity is supported by documentation in the medical record for a maximum of 3 years.  The maximum lifetime number of sessions will be 45 total. Subsequent treatments will not be covered.” This revision is due to a reconsideration request.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Reconsideration Request
05/04/2017 R5 Under Associated Information – Documentation Requirements- Grammatical correction made to ‘anticholinergic’ in paragraph under Utilization Guidelines. Under Sources of Information and Basis for Decision- Grammatical correction made to ‘Overactive’ from first reference article title.
  • Provider Education/Guidance
  • Typographical Error
10/01/2016 R4 Under ICD-10 Codes That Support Medical Necessity added ICD-10 code N39.492. This revision is due to the Annual ICD-10 Code Update and becomes effective 10/1/16.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
05/19/2016 R3 Under CMS National Coverage Policy deleted “an” for Title XVIII of the Social Security Act, §1862(a)(1)(A), deleted the abbreviation “IOM”, deleted “s” from Manuals, added “s” to Determination in the fourth cited manual reference, and added “s” to Requirement in the last cited manual reference. Under ICD-10 Codes That Support Medical Necessity-Group 1: Paragraph revised "diagnoses” to read "diagnosis”. Under Sources of Information and Basis for Decision supplement numbers and author initials were added and several author names were deleted to comply with the citation format. Under Sources of Information and Basis for Decision-Updated Sources #4 corrected the year of publication, and added the volume number, supplement number and page numbers. Under Sources of Information and Basis for Decision-Updated Sources #5 corrected the spelling of the author name Burgio, added the cited journal name, year of publication, volume number, supplement number and page numbers.
  • Provider Education/Guidance
  • Typographical Error
  • Other
10/01/2015 R2 Under CMS National Coverage Policy added one statutory reference and one CMS manual reference which were the following: Title XVIII of the Social Security Act, §1833(e), states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim and CMS Internet-Only Manuals (IOM), Publication 100-08, Medicare Program Integrity Manual, Ch. 3, §3.4.1.3, Diagnosis Code Requirement.
  • Provider Education/Guidance
  • Other (Added reference citations.)
10/01/2015 R1 Under CMS National Coverage Policyadded the description to Pub. 100-03, Ch. 1, §230.16, to read “Bladder Stimulators (Pacemakers)”. Also added regulatory citation 42 Code of Federal Register §411.15(k)(1), excluded services that are reasonable and necessary.)”. Under Sources of Information and Basis for Decision removed the verbiage "The development and coverage guidelines in this policy were based on a review of pertinent medical literature, policies from other Medicare contractors, and discussions with appropriate specialists," as this section is only for the bibliographies. The bibliographies were formatted by adding numbers to the references.
  • Provider Education/Guidance
  • Public Education/Guidance
N/A

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
07/11/2023 10/24/2019 - 07/11/2023 Retired You are here
10/14/2019 10/24/2019 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • PTNS

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