LCD/NCD Portal

L32304

 

POSTERIOR TIBIAL NERVE STIMULATION (PTNS)

 

01/31/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

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

o urinary urgency,

o urinary frequency, and

o urge incontinence

o for at least 12 months and

o 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

o at least two different anti-cholinergic drugs, or

o a combination of an anti-cholinergic and a tricyclic drug

o for a period of four to six weeks without improvement, or

o the documentation shows the patient is unable to tolerate these type drugs;

And

• The patient has tried behavioral treatments (e.g.,

o pelvic floor exercise,

o biofeedback,

o timed voids, or

o fluid management (not an all-inclusive list)

o 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.

o 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.”

o 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:

o 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.

o 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

o urologists,

o gynecologists, and

o Urogynecologists.

• PTNS treatment is intended for in-office use.

 

 

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 URINARY INCONTINENCE UNSPECIFIED

788.31 URGE INCONTINENCE

788.32 STRESS INCONTINENCE MALE

788.33 MIXED INCONTINENCE (MALE) (FEMALE)

788.34 INCONTINENCE WITHOUT SENSORY AWARENESS

788.35 POST-VOID DRIBBLING

788.36 NOCTURNAL ENURESIS

788.37 CONTINUOUS LEAKAGE

788.38 OVERFLOW INCONTINENCE

788.39 OTHER URINARY INCONTINENCE

788.41 URINARY FREQUENCY

788.63 URGENCY OF URINATION

 

 

Documentation 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.

o 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.

• Standard PTNS treatment regimens consist of 30-minute sessions given weekly for 12 weeks, only if the patient shows improvement after 6 treatments.

o 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.

 

Treatment Logic

• 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.

 

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.

 

01/31/2012

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 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.

 

CMS LCD L32304 Posterior Tibial Nerve Stimulation (PTNS)