L32304-LCD

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Local Coverage Determination (LCD) for Posterior Tibial Nerve Stimulation (PTNS) (L32304)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L32304

LCD Title

Posterior Tibial Nerve Stimulation (PTNS)

Contractor's Determination Number 64566

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 01/31/2012 Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/31/2012 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS On line Manual, Medicare Program Integrity Manual, Pub. 100-08, Chapter 13, Section 13.5.1

Indications and Limitations of Coverage and/or Medical Necessity

Percutaneous tibial nerve stimulation (PTNS) also referred to as 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. This is the least invasive form of neuromodulation used to treat overactive bladder (OAB) and the associated symptoms of urinary urgency, urinary frequency and urge incontinence. Common causes of voiding dysfunction are pelvic floor dysfunction (e.g., from pregnancy, childbirth, surgery), inflammation, medication (e.g., diuretics and anticholinergics), obesity, psychogenic factors, and disease (e.g., multiple sclerosis, spinal cord injury, detrusor hyper-reflexia).

PTNS treatment consists of a series of short-term insertions of a percutaneous needle electrode for approximately 30 minutes, with intermittent neuromodulation while the needle electrode remains in place. The neurostimulator includes a lead set with surface electrodes and a needle electrode, which produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. The sacral nerve plexus then regulates the bladder and the pelvic floor functionality.

Indications:

PTNS should not be performed as first line therapy for patients with OAB. It may be considered medically necessary and covered to treat patients with overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence when ALL of the following criteria have been met:

• The patient has experienced OAB with associated symptoms of urinary urgency, urinary frequency, and urge incontinence for at least 12 months and the condition has resulted in significant disability [the symptoms are limiting the patient’s ability to participate in activities of daily living (ADLs);] and

• The patient has tried at least two different anti-cholinergic drugs, or a combination of an anti-cholinergic and a tricyclic drug for a period of four to six weeks without improvement, or the documentation shows the patient is unable to tolerate these type drugs; and

• The patient has tried behavioral treatments (e.g., pelvic floor exercise, biofeedback, timed voids, or fluid management (not an all inclusive list) without improvement in the symptoms.

Limitations:

PTNS standard treatment regimen (30-minute sessions given weekly for 12 weeks) will be covered for treatment of OAB symptoms for patients either refractory or intolerant to standard anticholinergic drug therapy (i.e., failed treatment with two anticholinergic drugs, each taken for at least 4 weeks duration , prior to the PTNS therapy initiation). If the beneficiary fails to improve after 6 PTNS treatments, continued treatment is not considered medically necessary.

Another trial of the PTNS standard treatment regimen (30-minute sessions given weekly for 12 weeks) will be allowed for patients who have had successful treatment with PTNS and have returning symptoms of OAB after 24 months from the completion of the initial standard treatment regimen of PTNS.

PTNS treatment is contraindicated for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or patients who are pregnant or planning to become pregnant during the duration of the treatment.

Caution should be exercised for patients with heart problems related to pacing.

The CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf)outlines that “reasonable and necessary” services are “ordered and/or furnished by qualified personnel.” Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

A qualified physician for this service is defined as follows: Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty or must reflect extensive continued medical education activities. If these skills have been acquired by way of continued medical education, the courses must be comprehensive, offered, or sponsored, or endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States, and designated by the American Medical Association (AMA) as Category 1 Credit.

Types of providers who would be expected to perform this procedure are urologists, gynecologists, and urogynecologists. PTNS treatment is intended for in-office use.

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:

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.

CPT/HCPCS Codes

64566 POSTERIOR TIBIAL NEUROSTIMULATION, PERCUTANEOUS NEEDLE ELECTRODE, SINGLE TREATMENT, INCLUDES PROGRAMMING

ICD-9 Codes that Support Medical Necessity

596.51 HYPERTONICITY OF BLADDER

596.52 LOW BLADDER COMPLIANCE

596.55 DETRUSOR SPHINCTER DYSSYNERGIA

596.59 OTHER FUNCTIONAL DISORDER OF BLADDER

788.30 - 788.39 opens in new window URINARY INCONTINENCE UNSPECIFIED - OTHER URINARY

INCONTINENCE

788.41 URINARY FREQUENCY

788.63 URGENCY OF URINATION

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentations Requirements

The medical record must substantiate the medical need for PTNS with documentation of duration of symptoms and unsuccessful treatments for OAB as outlined under the “Indications” section of the LCD.

Medical record documentation must be made available to Medicare upon request. When the documentation does not meet the criteria for the service(s) rendered, or the documentation does not establish the medical necessity for the services(s), such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the

Social Security Act.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Standard PTNS treatment regimens consist of 30-minute sessions given weekly for 12 weeks, only if the patient shows improvement after 6 treatments. Another trial of the standard PTNS treatment regimen will be allowed for patients who have had successful treatment with PTNS and have returning symptoms of OAB after 24 months

from the completion of the initial standard treatment regimen of PTNS.

Sources of Information and Basis for Decision

Current Procedural Terminology, 2011. CPT Changes, An Insider’s View. American Medical Association.

Food and Drug Administration, 2010. Urgent® PC neuromodulation System, 510(k) premarket notification.

Leong, F., McLennan, M., Barr, S., & Steele, A., (2011). Posterior tibial nerve stimulation in patients who have failed anti-cholinergic therapy: Efficacy and time to response. Female Pelvic Medicine & Reconstructive Surgery, 17(2), 74-75.

MacDiarmid, S., Peters, K., Shobeiri, A., Wooldridge, L., Rovner, E., Leong, F., et al. (2010). Long-term durability of percutaneous tibial nerve stimulation for the treatment of overactive bladder. The Journal of Urology 183, 234- 240.

Martinson, M., (2008). Meta-Analysis of PTNS for Urinary Disorders. Technomics Research, LLC.

Peters, K., Carrico, D., Perez-Marrero, R., Khan, A., Wooldridge, L., Davis, G., & et al. (2010). Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: Results from the SUmiT Trial. The Journal of Urology 183, 1438-1443.

Peters, K., MacDiarmid, S., Wooldridge, L., Leong, F., Shobeiri, S., Rovner, E., et al. (2009). Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: Results from the overactive bladder innovative therapy trial. The Journal of Urology 182(3), 1055-1061.

Policies from other Medicare contractors and Private Insurers

Wrenn, J., & Michael, K. (2011). Incorporating percutaneous tibial nerve stimulation (PTNS) into a community based urology practice. Uro Today. Retrieved September 8, 2011 from http://www.urotoday.com/female-urology- 948/incorporating-percutaneous-tibial -nerve-stim.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies including urology and gynecology.

Florida Contractor Advisory Committee Meeting held on October 15, 2011.

Puerto Rico/U.S. Virgin Islands Contractor Advisory Committee Meeting held on October 20, 2011.

Start Date of Comment Period 10/07/2011

End Date of Comment Period 11/21/2011

Start Date of Notice Period 12/16/2011

Revision History Number original

Revision History Explanation Revision Number: original Start Date of Comment Period:10/07/2011

Start Date of Notice Period:12/16/2011 Original Effective Date:01/31/2012

LCR B2011-116

December 2011 Connection

Reason for Change