(Medicare National Coverage Determinations Manual)

N/A  D. Other  1. All other indications for home PT/INR monitoring not indicated as nationally covered above remain at local A/B MACs  discretion.  2. This national coverage determination (NCD) is distinct from, and makes no changes to, the PT clinical laboratory NCD at section 190.17 of Publica tion 100- 03 of the NCD Manual.   (This NCD last reviewed March 2008.)   190.12 - Urine Culture, Bacterial  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  A bacterial urine culture is a laboratory procedure performed on a urine specimen to establish the probable etiology of a presumed urinary tract infection.  It is common practice to do a urinalysis prior to a urine culture.  A urine culture may also be use d as part of the evaluation and management of another related condition.  The procedure includes aerobic agar -based isolation of bacteria or other cultivable organisms present, and quantitation of types present based on morphologic criteria.  Isolates deem ed significant may be subjected to additional identification and susceptibility procedures as requested by the ordering physician.  The physicians request may be through clearly documented and communicated laboratory protocols.  Indications   1. A patients u rinalysis is abnormal suggesting urinary tract infection, for example abnormal microscopic (hematuria, pyuria, bacteriuria); abnormal biochemical urinalysis (positive leukocyte esterase, nitrite, protein, blood); a Grams stain positive for microorganisms;  positive bacteriuria screen by a non -culture technique; or other significant abnormality of a urinalysis.  While it is not essential to evaluate a urine specimen by one of these methods before a urine culture is performed, certain clinical presentations w ith highly suggestive signs and symptoms may lend themselves to an antecedent urinalysis procedure where follow -up culture depends upon an initial positive or abnormal test result.   2. A patient has clinical signs and symptoms indicative of a possible urinary tract infection (UTI).  Acute lower UTI may present with urgency, frequency, nocturia, dysuria, discharge or incontinence.  These findings may also be noted in upper UTI with additional systemic symptoms (for example, fever, chills, lethargy); or pain in the costovertebral, abdominal, or pelvic areas.  Signs and symptoms may overlap considerably with other inflammatory conditions of the genitourinary tract (for example, prostatitis, urethritis, vaginitis, or cervicitis).  Elderly or immunocompromised patie nts, or patients with neurologic disorders may present atypically (for example, general debility, acute mental status changes, declining functional status).  3. The patient is being evaluated for suspected urosepsis, fever of unknown origin, or other systemic  manifestations of infection but without a know n source.  Signs and symptoms used to define sepsis have been well established.  4. A test -of-cure is generally not indicated in an uncomplicated infection.  However, it may be indicated if the patient is being e valuated for response to therapy and there is a complicating co -existing urinary abnormality including structural or functional abnormalities, calculi, foreign bodies, or ureteral/renal stents or there is clinical or laboratory evidence of failure to respond as described in Indications 1 and 2.  5. In surgical procedures involving major manipulations of the genitourinary tract, preoperative examination to detect occult infection may be indicated in selected cases (for example, prior to renal transplantation, m anipulation or removal of kidney stones, or transurethral surgery of the bladder of prostate).   6. Urine culture may be indicated to detect occult infection in renal transplantation recipients on immunosuppressive therapy.   Limitations   1. CPT 87086 may be used one time per encounter.   2. Colony count restrictions on coverage of CPT 87088 do not apply as they may be highly variable according to syndrome or other clinical circumstances (for example, antecedent therapy, collection time, degree of hydration).   3. CPT 87088, 87184, and 87186 may be used multiple times in association with or independent of 87086, as urinary tract infections may be polymicrobial.   4. Testing for asymptomatic bacteriuria as part of a prenatal evaluation may be medically appropriate but is co nsidered screening and therefore not covered by Medicare.  The U.S. Preventive Services Task Force has concluded that screening for asymptomatic bacteriuria outside of the narrow indication for pregnant women is generally not indicated.  There are insufficient data to recommend screening in ambulatory elderly patients including those with diabetes.  Testing may be clinically indicated on other grounds including likelihood of recurrence or potential adverse effects of antibiotics, but is considered screening in the absence of clinical or laboratory evidence of infection.  190.13 - Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring)  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  HIV quantification i s achieved through the use of a number of different assays, which measure the amount of circulating viral RNA.  Assays vary both in methods used to detect viral RNA as well as in ability to detect viral levels at lower limits.  However, all employ some type of nucleic acid amplification technique to enhance sensitivity, and results are expressed as the HIV copy number.   Quantification assays of HIV plasma RNA are used prognostically to assess relative risk for disease progression and predict time to death, as well as to assess efficacy of antiretroviral therapies over time.   The HIV quantification is often performed together with CD4+ T cell counts, which provide information on extent of HIV induced immune system damage already incurred.   Indications   1. A plasma HIV RNA baseline level may be medically necessary in any patient with confirmed HIV infection.  2. Regular periodic measurement of plasma HIV RNA levels may be medically necessary to determine risk for disease progression in an HIV -infected individual and to determine when to initiate antiretroviral treatment regimens.   3. In clinical situations where the risk of HIV infection is significant and initiation of therapy is anticipated, a baseline HIV quantification may be performed.  These situation include:   a. Persistence of borderline or equivocal serologic reactivity in an at -risk individual.  b. Signs and symptoms of acute retroviral syndrome characterized by fever, malaise, lymphadenopathy and rash in an at -risk individual   Limitations   1. Viral quantification may be appropriate for prognostic use including baseline determination, periodic monitoring and monitoring of response to therapy.  Use as a diagnostic test method is not indicated.  2. Measurement of plasma HIV RNA levels should be performed at the time of establishment of an HIV infection diagnosis.  For an accurate baseline, 2 specimens in a 2-week period are appropriate.   3. For prognosis including anti -retroviral therapy monitoring, regular, periodic measurements are appropriate.  The frequency of viral load testing should be consistent with the most current Centers for Disease Control and Prevention guidelines for use of antiretroviral agents in adults and adolescents or pediatrics.   4. Because differences in absolute HIV copy number are known to occur using different assays, plasma HIV RNA levels should be measured by the same analytical method.  A change in assay method may necessitate re- establishment of a baseline.   5. Nucleic acid quantification techniques are representative of rapidly emerging and evolving new technologies.  As such, users are advised to remain current of FDA -approved status.   190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis)  (Rev. 131, Issued: 02- 23-11, Effective: 12 -08-09, Implementation: 07- 06-10)  Diagnosis of HIV infection is primarily made through the use of serologic assays.  These assays take one of two forms: antibody detection assays and specific HIV antigen (p24) procedures.  The antibody assays are usually enzyme immunoassays (EIA), which ar e used to confirm exposure of an individuals immune system to specific viral antigens.  These assays may be formatted to detect HIV -1, HIV -2, or HIV -1 and 2 simultaneously, and to detect both IgM and IgG.  When the initial EIA test is repeatedly positive or indeterminant, an alternative test is used to confirm the specificity of the antibodies to individual viral components.  The most commonly used method is the Western Blot.   The HIV -1 core antigen (p24) test detects circulating viral antigen which may be  found prior to the development of antibodies and may also be present in later stages of illness in the form of recurrent or persistent antigenemia. Its prognostic utility in HIV infection has been diminished as a result of development of sensitive viral R NA assays, and its primary use today is as a routine screening tool in potential blood donors.  In several unique situations, serologic testing alone may not reliably establish an HIV infection.  This may occur because the antibody response (particularly t he IgG response detected by Western Blot) has not yet developed (that is, acute retroviral syndrome) or is persistently equivocal because of inherent viral antigen variability.  It is also an issue in perinatal HIV infection due to transplacental passage o f maternal HIV antibody.  In these situations, laboratory evidence of HIV in blood by culture, antigen assays, or proviral DNA or viral RNA assays, is required to establish a definitive determination of HIV infection.  Indications   Diagnostic testing to establish HIV infection may be indicated when there is a strong clinical suspicion supported by one or more of the following clinical findings:   1. The patient has a documented, otherwise unexplained, AIDS -defining or AIDS -associated opportunist ic infection.   2. The patient has another documented sexually transmitted disease, which identifies significant risk of exposure to HIV and the potential for an early or subclinical infection.   3. The patient has documented acute or chronic hepatitis B or C infection that identifies a significant risk of exposure to HIV and the potential for an early or subclinical infection.   4. The patient has a documented AIDS -defining or AIDS -associated neoplasm.   5. The patient has a documented AIDS -associated neurologic disorder or otherwise unexplained dementia.   6. The patient has another documented AIDS -defining clinical condition, or a history of other severe, recurrent, or persistent conditions which suggest an underlying immune deficiency (for example, cutaneous or mucosal disorders).   7. The patient has otherwise unexplained generalized signs and symptoms suggestive of a chronic process with an underlying immune deficiency (for example, fever, weight loss, malaise, fatigue, chronic diarrhea, failure to thrive, chronic cough, hemoptysis, shortness of breath, or lymphadenopathy).   8. The patient has otherwise unexplained laboratory evidence of a chronic disease process with an underlying immune deficiency (for example, anemia, leukopenia, pancytopenia, lymphopenia, or low CD4+ lymphocyte count).   9. The patient has signs and symptoms of acute retroviral syndrome with fever, malaise, lymphadenopathy, and skin rash.   10. The patient has documented exposure to blood or body fluids known to be capable of transmitting HIV  (for example, needle sticks and other significant blood exposures) and antiviral therapy is initiated or anticipated to be initiated.   11. The patient is undergoing treatment for rape. (HIV testing is part of the rape treatment protocol.)   Limitations   1. HIV antibody testing in the United States is usually performed using HIV -1 or HIV -1/2 combination tests.  HIV -2 testing is indicated if clinical circumstances suggest HIV -2 is likely (that is, compatible clinical finding and HIV -1 test negative). HIV -2 testing may also be indicated in areas of the country where there is greater prevalence of HIV -2 infections.  2. The Western Blot test should be performed only after documentation that the initial EIA tests are repeatedly positive or equivocal on a single sample.   3. The HIV antigen tests currently have no defined diagnostic usage.   4. Direct viral RNA detection may be performed in those situations where serologic testing does not establish a diagnosis but strong clinical suspicion persists (for exam ple, acute retroviral syndrome, nonspecific serologic evidence of HIV, or perinatal HIV infection).   5. If initial serologic tests confirm an HIV infection, repeat testing is not indicated.   6. If initial serologic tests are HIV EIA negative and there is n o indication for confirmation of infection by viral RNA detection, the interval prior to retesting is 3- 6 months.  7. Testing for evidence of HIV infection using serologic methods may be medically appropriate in situations where there is a risk of exposure  to HIV.   8. The CPT Editorial Panel has issued a number of codes for infectious agent detection by direct antigen or nucleic acid probe techniques that have not yet been developed or are only being used on an investigational basis.  Laboratory providers a re advised to remain current on FDA -approved status for these tests.