evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
Payment for DSA should not exceed, and may be less than, that being paid for conventional angiographic techniques.   220.10 - Portable Hand -Held X -Ray Instrument  (Rev. 1, 10- 03-03) CIM 50 -48  This low intensity x -ray imaging device is a light weight  portable hand -held instrument using a low level isotope as its penetrating energy source.  It can picture any part of the human anatomy that can be inserted in the space between the energy source and the viewing mechanism.  The device can be useful in making an immediate diagnosis in the following settings: isolated areas, accident scenes, sports events and emergency rooms.  It is also useful in the following instances where fluoroscopy would ordinarily be used:  localization of foreign bodies, selected surgical procedures and the evaluation of premature or low birth weight infants.  The use of the portable hand- held x- ray instrument as an imaging device is covered under Medicare.  It should be reimbursed as part of the physicians professional service, and no additional charge should be allowed.   220.11 - Thermography (Rev. 1, 10- 03-03) CIM 50 -5  Thermography is the measurement of self -emanating infrared radiation that reveals temperature variations at the surface of the body.  The thermographic device senses body temperature and demonstrates areas of differing heat emission by producing brightly c olored patterns.  Each color represents a specific temperature level.  Interpretation of these color patterns according to designated anatomic distribution is thought to aid in diagnosing a vast array of diseases.   Thermography for any indication (including breast lesions which were excluded from Medicare coverage on July 20, 1984) is excluded from Medicare coverage because the available evidence does not support this test as a useful aid in the diagnosis or treatment of illness or injury.  Therefore, it is not considered effective.  This exclusion was published as a CMS Final Notice in the Federal Register on November 20, 1992.   220.12 - Single Photon Emission Computed Tomograph (SPECT)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  The single photon emission computed tomograph (SPECT) acquires information on the concentration of radionuclides introduced into the patients body.  It is useful in the diagnosis of several clinical conditions including:
(Medicare National Coverage Determinations Manual)
The single photon emission computed tomograph (SPECT) acquires information on the concentration of radionuclides introduced into the patients body.  It is useful in the diagnosis of several clinical conditions including:    Stress fracture   Spondylosis   Infection (e.g., discitis)   Tumor (e.g., osteoid osteoma)   Analyze blood flow to an organ, as in the case of myocardial viability  Differentiate ischemic heart disease from dilated cardiomyopathy.   Frequency limitations:  A/B MAC (A)s or (B)s discretion.   In the case of myocardial viability, FDG positron emission tomography (PET) may be used following a SPECT that was found to be inconclusive.  However, SPECT may not be used following an inconclusive FDG PET performed to evaluate myocardial viability.   220.13 - Percutaneous Image -Guided Breast Biopsy  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  Percutaneous image- guided breast biopsy is a method of obtaining a breast biopsy through a percutaneous incision by employing image guidance systems.  Image guidance systems may be either ultrasound or stereotactic.   The Breast Imaging Reporting and Data System (or BIRADS system) employed by the American College of Radiology provides a standardized lexicon with which radiologists may report their interpretation of a mammogram.  The BIRADS grading of mammograms is as follows: Grade I -Negative, Grade II -Benign finding, Grade III -Probably benign, Grade IV -Suspicious abnormality, and Grade V -Highly suggestive of malignant neoplasm.  A. Non -Palpable Breast Lesions   Effective January 1, 2003, Medicare covers percutaneous image -guided breast biopsy using stereotactic or ultrasound imaging for a radiographic abnormality that is non- palpable and is graded as a BIRADS III, IV, or V.   B. Palpable Breast Lesions
(Medicare National Coverage Determinations Manual)
B. Palpable Breast Lesions   Effective January 1, 2003, Medicare covers percutaneous image guided breast biopsy using stereotactic or ultrasound imaging for palpable lesions that are difficult to biopsy using palpation alone.  A/B MACs (A) and (B) have the discretion to decide what types of palpable lesions are difficult to biopsy using palpation.  230 - Renal and Genitourinary System - ESRD Services   230.1 - Treatment of Kidney Stones  (Rev. 1, 10- 03-03) CIM 35 -81  Traditional approaches for the treatment of kidney stones are the surgical technique nephrectomy (or nephrotomy) and endoscopic treatments via the urethra.  In the last few years, several new approaches in the surgical management of upper urinary tract kidney stones have been developed, among them invasive and noninvasive lithotripsy techniques.  In addition to the traditional surgical/endoscopic techniques for the treatment of kidney stones, the following lithotripsy techniques are also covered for services rendered on or after March 15, 1985.  A.  Extracorporeal Shock Wave Lithotripsy  Extracorporeal Shock Wave Lithotripsy (ESWL) is a noninvasive method of treating kidney stones using a device called a lithotriptor.  The lithotriptor uses shock waves generated outside of the body to break up upper urinary tract stones.  It focuses the shock waves specifically on stones under x- ray visualization, pulverizing them by repeated shocks.  ESWL is covered under Medicare for use in the treatment of upper urinary tract kidney stones.   B.  Percutaneous Lithotrips y  Percutaneous lithotripsy (or nephrolithotomy) is an invasive method of treating kidney stones by using ultrasound, electrohydraulic or mechanical lithotripsy.  A probe is inserted through an incision in the skin directly over the kidney and applied to the stone. A form of lithotripsy is then used to fragment the stone.  Mechanical or electrohydraulic lithotripsy may be used as an alternative or adjunct to ultrasonic lithotripsy.  Percutaneous lithotripsy of kidney stones by ultrasound or by the related techniques of electrohydraulic or mechanical lithotripsy is covered under Medicare.
(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;
(Medicare National Coverage Determinations Manual)
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.)
(Medicare National Coverage Determinations Manual)
(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.
(Medicare National Coverage Determinations Manual)
 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
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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
(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.
(Medicare National Coverage Determinations Manual)
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.