(Medicare National Coverage Determinations Manual)

230.10 - Incontinence Control Devices  (Rev. 1, 10- 03-03) CIM 65 -9  A.  Mechanical/Hydraulic Incontinence Control Devices   Mechanical/hydraulic incontinence control devices are accepted as safe and effective in the management of urinary incontinence in patients with permanent anatomic and neurologic dysfunctions of the bladder.  This class of devices achieves control of urinat ion by compression of the urethra.  The materials used and the success rate may vary somewhat from device to device.  Such a device is covered when its use is reasonable and necessary for the individual patient.   B.  Collagen Implant   A collagen implant which is injected into the submucosal tissues of the urethra and/or the bladder neck and into tissues adjacent to the urethra, is a prosthetic device used in the treatment of stress urinary incontinence resulting from intrinsic sphincter  deficiency (ISD). ISD is a cause of stress urinary incontinence in which the urethral sphincter is unable to contract and generate sufficient resistance in the bladder, especially during stress maneuvers.   Prior to collagen implant therapy, a skin test for collagen sensitivity must be administered and evaluated over a 4 -week period.  In male patients, the evaluation must include a complete history and physical examination and a simple cystometrogram to determine that the bladder fills and stores properly.  The patient then is asked to stand upright with a full bladder and to cough or otherwise exert abdominal pressure on his bladder.  If the patient leaks, the diagnosis of ISD is established.   In female patients, the evaluation must include a complete history and physical examination (including a pelvic exam) and a simple cystometrogram to rule out abnormalities of bladder compliance and abnormalities of urethral support.  Following that determi nation, an abdominal leak point pressure (ALLP) test is performed.  Leak point pressure, stated in cm H2O, is defined as the intra -abdominal pressure at which leakage occurs from the bladder (around a catheter) when the bladder has been filled with a minimum of 150 cc fluid.  If the patient has an ALLP of less than 100 cm H2O, the diagnosis of ISD is established.  To use a collagen implant, physicians must have urology training in the use of a cystoscope and must complete a collagen implant training program.   Coverage of a collagen implant, and the procedure to inject it, is limited to the following types of patients with stress urinary incontinence due to ISD:    Male or female patients with congenital sphincter weakness secondary to conditions such as myelomeningocele or epispadias;    Male or female patients with acquired sphincter weakness secondary to spinal cord lesions;    Male patients following trauma, including prostatectomy and/or radiation; and   Female patients without urethral hypermobility and with abdominal leak point pressures of 100 cm H2O or less.   Patients whose incontinence does not improve with five injection procedures (five separate treatment sessions) are considered treatment failures, and no further treatment of urinary incontinence by collagen implant is covered.  Patients who have a reoccurr ence of incontinence following successful treatment with collagen implants in the past (e.g., 6- 12 months previously) may benefit from additional treatment sessions.  Coverage of additional sessions may be allowed but must be supported by medical justifica tion.  See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 120.  (See 230.8.)   230.11-  Diagnostic Pap Smears (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)         The guide in 190.2 applies.   230.12 - Dimethyl Sulfoxide (DMSO)  (Rev. 1, 10- 03-03) CIM 45- 23  The DMSO is an industrial solvent produced as a chemical byproduct of paper production from wood pulp.  The Food and Drug Administration has determined that the only purpose for which DMSO is safe and effective for humans is in the treatment of the bladder  condition, interstitial cystitis.  Therefore, the use of DMSO for all other indications is not considered to be reasonable and necessary.  Payment may be made for its use only when reasonable and necessary for a patient in the treatment of interstitial cy stitis.   230.13 - Peridex CAPD Filter Set  (Rev. 1, 10- 03-03) CIM 55 -2  The Peridex Filter Set is used by home continuous ambulatory peritoneal dialysis (CAPD) patients.  The Peridex Filter Set is designed to provide sterile filtration during infusion of the dialysis solution in a beneficiarys peritoneal cavity; included in the filter set is a bacterial filter designed to block peritonitis -causing organisms and thus reduce  the incidence of peritonitis.   Based upon advice of our medical consultants, CMS has determined that the Peridex CAPD Filter Set cannot be covered at this time by Medicare because it has not yet been shown to be safe and effective in preventing peritonitis.  230.14 - Ultrafiltration Monitor  (Rev. 1, 10- 03-03) CIM 55 -3  The Ultrafiltration Monitor is designed to reduce the clinical risks of overfiltration and underfiltration during hemodialysis.  Overfiltration is the removal of too much fluid from body tissues and underfiltration is removal of too little fluid.   Covered   Ultrafiltration and ultrafiltration monitoring as a component of hemodialysis has an established and critical role in maintaining the well- being of ESRD patients and is a covered service.  The Ultrafiltration Monitor is covered under the Medicare program when it is used to calculate fluid rates for those recipients who present difficult fluid management problems.  Determine the medical necessity of this device on a case -by-case basis.   Not Covered   Ultrafiltration, independent of conventional dialysis, is considered experimental, and technology exclusively designed for this purpose is not covered under Medicare.   230.15 - Electrical Continence Aid  (Rev. 1, 10- 03-03) CIM 65 -2  Not Covered   An electrical continence aid is a device consisting of a plastic plug, molded into the shape of the patients anal canal which contains two implanted electrodes that are connected by a wire to a small portable generator.  An electrical current is produced which stimulates the anal musculature to cause a contraction sufficient to hold the plug in while allowing the patient to ambulate without incontinence.   Electrical continence aids are in the experimental stage of development and there is no valid scientific documentation of their effectiveness and safety.  Therefore, they are not covered under Medicare since they cannot be considered to be reasonable and n ecessary for the treatment of an illness or injury or to improve the functioning of a malformed body member as required by 1862(a)(1)  of the Act.   230.16 - Bladder Stimulators (Pacemakers)  (Rev. 1, 10- 03-03) CIM 65 -11  Not Covered   There are a number of  devices available to induce emptying of the urinary bladder by using electrical current which forces the muscles of the bladder to contract.  These devices (commonly known as bladder stimulators or pacemakers) are characterized by the implantation of elec trodes in the wall of the bladder, the rectal cones, or the spinal cord.  While these treatments may effectively empty the bladder, the issue of safety involving the initiation of infection, erosion, placement, and material selection has not been resolved.   Further, some facilities previously using electronic emptying have stopped using this method due to the pain experienced by the patient.   The use of spinal cord electrical stimulators, rectal electrical stimulators, and bladder wall stimulators is not considered reasonable and necessary.  Therefore, no program payment may be made for these devices or for their implant.  230.17 - Urinary Drainage Bags  (Rev. 1, 10- 03-03) CIM 65 -17  Urinary collection and retention systems are covered as prosthetic devices that replace bladder function in the case of permanent urinary incontinence.  Urinary drainage bags that can be used either as bedside or leg drainage bags may be either multi -use or single use systems.  Both the multi- use and the single use bags have a system that prevents urine backflow.  However, the single use system is non- drainable.  There is insufficient evidence to support the medical necessity of a single use system bag rather than the multi -use bag.  Therefore, a single use drainage system  is subject to the same coverage parameters as the multi -use drainage bags.   230.18 - Sacral Nerve Stimulation for Urinary Incontinence  (Rev. 1, 10- 03-03) CIM 65 -18  Effective January 1, 2002, sacral nerve stimulation is covered for the treatment of urinary urge incontinence, urgency- frequency syndrome, and urinary retention.  Sacral nerve stimulation involves both a temporary test stimulation to determine if an implantable stimulator would be effective and a permanent implantation in appropriate candidates. Both the test and the permanent implantation are covered.   The following limitations for coverage apply to all three indications:    Patient must be refractory to conventional therapy (documented behavioral, pharmacologic and/or surgical corrective therapy) and be an appropriate surgical candidate such that implantation with anesthesia can occur.    Patients with stress incontinence, urinary obstruction, and specific neurologic diseases (e.g., diabetes with peripheral nerve involvement) which are associated with secondary manifestations of the above three indications are excluded.    Patient must have had a successful test stimulation in order to support subsequent implantation.  Before a patient is eligible for permanent implantation, he/she must demonstrate a 50 percent or greater improvement through test stimulation.  Improvement is measured through voiding diaries.   Patient must be able to demonstrate adequate ability to record voiding diary data such that clinical results of the implant procedure can be properly evaluated.   230.19 - Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients  (Rev. 48, Issued:  03- 17-06; Effective/Implementation Dates:  06 -19-06) CIM 45 -32  Carnitine is a naturally occurring substance that functions in the transport of the long- chain fatty acids for energy production by the body.  Deficiency can occur due to a congenital defect in synthesis or utilization, or from dialysis.  The causes of car nitine deficiency in hemodialysis patients include dialytic loss, reduced renal synthesis and reduced dietary intake.   Intravenous levocarnitine, for one of the following indications, will only be covered for those ESRD patients who have been on dialysis for a minimum of three months.  Patients must have documented carnitine deficiency, defined as a plasma free carnitine level < 40 micromol/L (determined by a professionally accepted method as recognized in current literature), along with signs and symptoms of:    Erythropoietin- resistant anemia (persistent hematocrit  < 30 percent with treatment) that has not responded to standard erthropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or    Hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g., fluid management).  Such episodes of hypotension must have occurred during at least 2 dialysis treatments in a 30- day pe riod.  Continued use of levocarnitine will not be covered if improvement has not been demonstrated within 6 months of initiation of treatment.  All other indications for levocarnitine are noncovered in the ESRD population.   For a patient currently receiving intravenous levocarnitine, Medicare will cover continued treatment if:   Levocarnitine has been administered to treat erythropoietin- resistant anemia (persistent hematocrit <  30 percent with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g ., fluid management) and such episodes of hypotension occur during at least 2 dialysis treatments in a 30- day period; and   The patients medical record documents a pre -dialysis plasma free carnitine level < 40 micromol/L prior to the initiation of treatment; or