LCD L35486

Coverage Guidance

Title XVIII of the Social Security Act Section 1833 (e). This section states that no payment shall be made to any provider for any claims that lack necessary information to process the claim.

Title XVIII of the Social Security Act Section 1862 (a)(1)(A). This section allows coverage and payment of those services that are considered to be medically reasonable and necessary.

Title XVIII of the Social Security Act Section 1862 (a)(7). This section excludes routine physical examinations and services.

CMS Pub. 100-03 Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 1, Section 30.1.1 Biofeedback Therapy for Treatment of Urinary Incontinence.

CMS Pub. 100-03 Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 230.8 Non-Implantable Pelvic Floor Electrical Stimulator.

CMS Pub. 100-03 Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 230.18 Sacral Nerve Stimulation for Urinary Incontinence.

42 Code of Federal Regulations, 410.32

Italicized font -represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.

Indications and Limitations of Coverage

The pelvic floor is a dome-shaped muscle complex with contraction occurring in 3 planes. Its complex actions include tightening, lifting, squeezing, and relaxing. Pelvic floor muscles support organs within the pelvis and lower abdomen, maintain continence, allow for bladder and bowel emptying, and contribute to sexual arousal. Pelvic floor dysfunction is recognized to be related to lower urinary tract dysfunction and to lower gastrointestinal symptoms and is an influential factor in dysfunction and subsequent behavior of the genital system in both men and women.

Electromyography (EMG) studies of the anal or urethral sphincters will be considered medically reasonable and necessary when it is necessary to evaluate a diagnosis of fecal or urinary incontinence, dysfunctional bladder elimination and interstitial cystitis respectively, and to identify possible underlying neurological disease and the results are to be used in the management of the patient’s condition.

An EMG of the anal or urethral sphincter is a diagnostic test that measures muscle activity and is used to assist in evaluating fecal or urinary incontinence, dysfunctional elimination of bowel and bladder and neurogenic bladder dysfunction leading to functional abnormalities of the muscular sphincter.

Anorectal manometry is a diagnostic test that measures the anal sphincter pressures and provides an assessment of rectal sensation, rectoanal reflexes, and rectal compliance.

Anorectal manometry will be considered medically reasonable and necessary when it is necessary to evaluate a diagnosis of fecal incontinence and dysfunctional anorectal elimination and the results are to be used in the management of the patient’s condition.

These diagnostic tests are considered medically necessary when there has been an appropriate evaluation and justification prior to the tests being performed and when the results of the diagnostic test are used in the management of the specific medical problem. There must be a complete history and physical exam documented before the decision to perform one of the diagnostic tests is made.

All diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary, (42CRF, 410.32)

Indications

Fecal incontinence is the involuntary loss of stool (gas, liquid or solid). Fecal incontinence is caused by a disruption of the normal function of both the lower digestive tract and the nervous system. Fecal incontinence can be caused by several factors:

• Constipation;

• Damage to the anal sphincter muscle (e.g., childbirth or hemorrhoid surgery);

• Damage to the nerves of the anal sphincter muscles of the rectum (e.g., childbirth, straining to pass stool, stroke, physical disability due to injury, diabetes or multiple sclerosis);

• Loss of the storage capacity in the rectum;

• Diarrhea;

• Pelvic floor dysfunction.

Urinary incontinence is the involuntary leakage of urine. Male and females have different risk factors in developing urinary incontinence. The risk of urinary incontinence increases with age in both men and women, but women are more likely to develop urinary incontinence due to anatomical differences in the pelvic region and due to changes caused by pregnancy and childbirth. There are several types of urinary incontinence;

• Stress Incontinence

• Urge Incontinence

• Overflow Incontinence

• Mixed Incontinence

Some causes of these different types of urinary incontinence are medications, vaginal atrophy, decreased lubrication, weakness of the pelvic floor and supporting structures, pelvic fracture, pelvic surgeries, neurological deficits and radical prostatectomy.

Typically, the causes of urinary or fecal incontinence can be diagnosed upon completion of a thorough history and physical exam performed by the physician or non-physician practitioner. When a thorough history and physical does not point to one or more causes of urinary or fecal incontinence, diagnostic testing may be indicated.

In addition, other pelvic floor disorders present symptoms such as dysfunctional voiding, incomplete bladder and/or rectal elimination and sexual dysfunction. Many of these disorders are characterized by spasticity of the pelvic floor and floor hypertonicity, which are abnormal contractions of the muscles of the pelvic floor. These conditions may also be detected on a physical examination, but in cases that are indeterminate, diagnostic testing may aid the diagnosis.

Limitations

Anorectal Manometry and Pelvic Floor EMG studies are diagnostic tests. Therefore Medicare would only expect to see Anorectal Manometry and Pelvic Floor EMG’s billed once during the initial diagnostic evaluation. These tests are considered to be medically necessary only when the cause of the fecal incontinence or urinary incontinence cannot be determined from the physician’s evaluation and the physician has determined that diagnostic testing is needed to make a diagnosis. There may be rare occasions when the physician feels one of these diagnostic tests are needed after a course of treatment has been completed. In this instance, Medicare would expect the medical record to reflect that the results of the additional test are needed to determine additional therapy or treatment.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Utilization Guidelines

Anorectal Manometry and Pelvic Floor EMG are diagnostic tests and should not be performed on a routine basis. Medicare would not expect to see an Anorectal Manometry billed when the physician is trying to evaluate urinary incontinence. Medicare would not expect these tests to be billed more than twice in a lifetime.

The CPT Codes for Anorectal Manometry and Pelvic Floor EMG are diagnostic. They are not a medically necessary part of physical therapy, rehabilitation, biofeedback, or exercise program treatment plans.

Bibliography

Cheng D. Relationship between anorectal pressure and pelvic floor muscle tension in patients with pelvic floor organ prolapse accompanied by outlet obstruction. Gynecologic and Obstetric Investigation. 2011;72(3):174-178. doi:10.1159/000326678.

Faubion SS, Shuster LT, Bharucha AE. Recognition and management of nonrelaxing pelvic floor dysfunction. Mayo Clinic Proceedings. 2012;87(2):187-93.

Gundling F, Seidl H, Scalercio N, Schmidt T, Schepp W, Pehl C. Influence of gender and age on anorectal function: normal values from anorectal manometry in a large caucasian population. Digestion. 2010;81(4):207-213. doi:10.1159/000258662.

Khandelwal C, Kistler C. Diagnosis of urinary incontinence. American Family Physician. 2013:87(8):543-550.

Rosier P, de Ridder D, Meijlink J, Webb R, Whitmore K, Drake M. Developing evidence-based standards for diagnosis and management of lower urinary tract or pelvic floor dysfunction. Neurology and Urodynamics. 2012;31(5):621-624. doi:10.1002/nau.21253.

Vodusek D, Janko M, Lokar J. EMG, single fiber EMG and sacral reflexes in assessment of sacral nervous system lesions. Journal of Neurology, Neurosurgery, and Psychiatry. 1982;45(11):1064-1066.

Voorham-van der Zalm P, Lycklama A Nijeholt G, Elzevier H, Putter H, Pelger R. "Diagnostic investigation of the pelvic floor": a helpful tool in the approach in patients with complaints of micturition, defecation, and/or sexual dysfunction. The Journal of Sexual Medicine. 2008;5(4):864-871. doi:10.1111/j.1743-6109.2007.00725.x.