(Medicare National Coverage Determinations Manual)

The following is covered for services rendered on or after January 16, 1988.  C.  Transurethral Ureteroscopic Lithotripsy   Transurethral ureteroscopic lithotripsy is a method of fragmenting and removing ureteral and renal stones through a cystoscope.  The cystoscope is inserted through the urethra into the bladder.  Catheters are passed through the scope into the opening where  the ureters enter the bladder.  Instruments passed through this opening into the ureters are used to manipulate and ultimately disintegrate stones, using either mechanical crushing, transcystoscopic electrohydraulic shock waves, ultrasound, or laser.  Tra nsurethral ureteroscopic lithotripsy for the treatment of urinary tract stones of the kidney or ureter is covered under Medicare.   230.2 - Uroflowmetric Evaluations  (Rev. 1, 10- 03-03) CIM 50 -33  Uroflowmetric evaluations (also referred to as urodynamic voiding or urodynamic flow studies) are covered under Medicare for diagnosing various urological dysfunctions, including bladder outlet obstructions.  230.3 - Sterilization  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A.   Nationally Covered Conditions    Payment may be made only where sterilization is a necessary part of the treatment of an illness or injury, e.g., removal of a uterus because of a tumor or removal of diseased ovaries.    Sterilization of a mentally challenged beneficiary is covered if it is a necessary part of the treatment of an illness or injury (bilateral oophorectomy or bilateral orchidectomy in a case of cancer of the prostate).  The A/B MAC (A) or (B) denies claims w hen the pathological evidence of the necessity to perform any such procedures to treat an illness or injury is absent; and    Monitor such surgeries closely and obtain the information needed to determine whether in fact the surgery was performed as a means of treating an illness or injury or only to achieve sterilization.   B.   Nationally Non -Covered Conditions    Elective hysterectomy, tubal ligation, and vasectomy, if the primary indication for these procedures is sterilization;   A sterilization that is performed because a physician believes another pregnancy would endanger the overall general health of the woman is not considered to be reasonable and necessary for the diagnosis or treatment of illness or injury within the meaning of 1862(a)(1)  of the Social Security Act.  The same conclusion would apply where the sterilization is performed only as a measure to prevent the possible development of, or effect on, a mental condition should the individual become pregnant; and sterilization of a ment ally retarded person where the purpose is to prevent conception, rather than the treatment of an illness or injury.   230.4 - Diagnosis and Treatment of Impotence  (Rev. 1, 10- 03-03) CIM 35 -24  Program payment may be made for diagnosis and treatment of sexual impotence. Impotence is a failure of a body part for which the diagnosis, and frequently the treatment, require medical expertise.  Depending on the cause of the condition, treatment may be surgical; e.g., implantation of a penile prosthesis, or nonsurgical; e.g., medical or psychotherapeutic treatment.  Since causes and, therefore, appropriate treatment vary, if abuse is suspected it may be necessary to request documentation of appropriatene ss in individual cases.  If treatment is furnished to patients (other than hospital inpatients) in connection with a mental condition, apply the psychiatric service limitation described in the Medicare General Information, Eligibility, and Entitlement Manu al, Chapter 3.   230.5 - Gravlee Jet Washer  (Rev. 1, 10- 03-03) CIM 50 -4  The Gravlee Jet Washer is a sterile, disposable, diagnostic device for detecting endometrial cancer.  The use of this device is indicated where the patient exhibits clinical symptoms or signs suggestive of endometrial disease, such as irregular or heavy vaginal bleeding.  Program payment cannot be made for the washer or the related diagnostic services when furnished in connection with the examination of an asymptomatic patient.  Payment for routine physical checkups is precluded under the statute. (See 1862(a)(7)  of the Act.)   (See the Medicare Benefit Policy Manual, Chapter 16, General Exclusions From Coverage, 90).  230.6 - Vabra Aspirator  (Rev. 1, 10- 03-03) CIM 50 -10  The VABRA aspirator is a sterile, disposable, vacuum aspirator which is used to collect uterine tissue for study to detect endometrial carcinoma.  The use of this device is indicated where the patient exhibits clinical symptoms or signs suggestive of endometrial disease, such as i rregular or heavy vaginal bleeding.   Program payment cannot be made for the aspirator or the related diagnostic services when furnished in connection with the examination of an asymptomatic patient.  Payment for routine physical checkups is precluded under the statute (1862(a)(7) of the Act).   Cross -reference:   See the Medicare Benefit Policy Manual, Chapter 16, General Exclusions From Coverage, 90, and 230.5 of this manual.  230.7 - Water Purification and Softening Systems Used in Conjunction With Home Dialysis  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A.  Water Purification Systems   Water used for home dialysis should be chemically free of heavy trace metals and/or organic contaminants that could be hazardous to the patient.  It should also be as free of bacteria as possible but need not be biologically sterile.  Since the characteris tics of natural water supplies in most areas of the country are such that some type of water purification system is needed, such a system used in conjunction with a home dialysis (either peritoneal or hemodialysis) unit is covered under Medicare.   There are two types of water purification systems that will satisfy these requirements:   Deionization -  The removal of organic substances, mineral salts of magnesium and calcium (causing hardness), compounds of fluoride and chloride from tap water using the process of filtration and ion exchange; or    Reverse Osmosis (RO) -  The process used to remove impurities from tap water utilizing pressure to force water through a porous membrane.  Use of both a deionization unit and RO unit in series, theoretically to provide the advantages of both systems, has been determined medically unnecessary since either system can provide water which is both chemically and bacteriologically pure enough for a cceptable use in home dialysis.  In addition, spare deionization tanks are not covered since they are essentially a precautionary supply rather than a current requirement for treatment of the patient.   Activated carbon filters used as a component of water purification systems to remove unsafe concentrations of chlorine and chloramines are covered when prescribed by a physician.   B.  Water Softening System   Except as indicated below, a water softening system used in conjunction with home dialysis is excluded from coverage under Medicare as not being reasonable and necessary within the meaning of 1862(a)(1)  of the Social Security Act.  Such a system, in conjunction with a home dialysis unit, does not adequately remove the hazardous heavy metal contaminants (such as arsenic) which may be present in trace amounts.   A water softening system may be covered when used to pretreat water to be purified by a RO unit for home dialysis where:   The manufacturer of the RO unit has set standards for the quality of water entering the RO (e.g., the water to be purified by the RO must be of a certain quality if the unit is to perform as intended);   The patients water is demonstrated to be of a lesser quality than required; and,  The softener is used only to soften water entering the RO unit, and thus, used only for dialysis.  (The softener need not actually be built into the RO unit, but must be an integral part of the dialysis system.)   C.  Developing Need When a Water Softening System is Replaced with a Water Purification Unit in an Existing Home Dialysis System   The medical necessity of water purification units must be carefully developed when they replace water softening systems in existing home dialysis systems.  A purification system may be ordered under these circumstances for a number of reasons. For example,  changes in the medical communitys opinions regarding the quality of water necessary for safe dialysis may lead the physician to decide the quality of water previously used should be improved, or the water quality itself may have deteriorated.  Patients m ay have dialyzed using only an existing water softener previous to Medicare end -stage renal disease coverage because of inability to pay for a purification system.  On the other hand, in some cases, the installation of a purification system is not medically necessary.  Thus, when such a case comes to the A/B M AC (A)s attention, the MAC asks the physician to furnish the reason for the changes.  Supporting documentation, such as the suppliers recommendations or water analysis, may be required.  All such cases should be reviewed by the MACs medical consultants.   Cross reference: -  The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 110.  230.8 - Non-Implantable Pelvic Floor Electrical Stimulator  (Rev. 48, Issued:  03- 17-06; Effective/Implementation Dates:  06 -19-06) CIM 60 -24  Non-implantable pelvic floor electrical stimulators provide neuromuscular electrical stimulation through the pelvic floor with the intent of strengthening and exercising pelvic floor musculature. Stimulation is generally delivered by vaginal or anal probes connected to an external pulse generator.   The methods of pelvic floor electrical stimulation vary in location, stimulus frequency (Hz), stimulus intensity or amplitude (mA), pulse duration (duty cycle), treatments per day, number of treatment days per week, length of time for each treatment sessio n, overall time period for device use and between clinic and home settings.  In general, the stimulus frequency and other parameters are chosen based on the patients clinical diagnosis.  Pelvic floor electrical stimulation with a non -implantable stimulator is covered for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training.   A failed trial of PME training is defined as no clinically significant improvement in urinary continence after completing 4 weeks of an ordered plan of pelvic muscle exercises designed to increase periurethral muscle strength.   230.9 - Cryosurgery of Prostate  (Rev. 1, 10- 03-03) CIM 35 -96  Cryosurgery of the prostate gland, also known as cryosurgical ablation of the prostate (CSAP), destroys prostate tissue by applying extremely cold temperatures in order to reduce the size of the prostate gland.  It is safe and effective, as well as medical ly necessary and appropriate, as primary treatment for patients with clinically localized prostate cancer, Stages T1 -T3.  Cryosurgery of the prostate as a salvage therapy is not covered for any services performed prior to June 30, 2001.  Salvage Cryosurgery Of Prostate After Radiation Failure.  Salvage cryosurgery of the prostate for recurrent cancer is medically necessary and appropriate only for those patients with localized disease who:   1.   Have failed a trial of radiation therapy as their primary treatment; and   2.   Meet one of the following conditions:  Stage T2B or below, Gleason score <  9, PSA <  8 ng/mL.  Cryosurgery as salvage therapy is therefore not covered under Medicare after failure of other therapies as the primary treatment.  Cryosurgery as salvage is only covered after the failure of a trial of radiation therapy, under the conditions noted above.   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.