evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
 Previous 4cancer of the cervix, uterus, or vagina that has been or is presently being treated;    Previous abnormal pap smear;    Any abnormal findings of the vagina, cervix, uterus, ovaries, or adnexa;    Any significant complaint by the patient referable to the female reproductive system; or    Any signs or symptoms that might in the physicians judgment reasonably be related to a gynecologic disorder.   Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer.  (See section 210.2.)   190.3 - Cytogenetic Studies (Rev. 1, 10- 03-03) CIM 50 -29  The term cytogenetic studies is used to describe the microscopic examination of the physical appearance of human chromosomes.  Medicare covers these tests when they are reasonable and necessary for the diagnosis or treatment of the following conditions:   Genetic disorders (e.g., mongolism) in a fetus (See the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 20.1   Failure of sexual development; or   Chronic myelogenous leukemia.   Acute leukemias lymphoid (FAB L1-L3), myeloid (FAB M0- M7), and unclassified; or   Myelodysplasia.  190.4 - Electron Microscope  (RETIRED) (Rev. 11892; Issued: 03-09- 23; Effective: 04 -10-23; Implementation:04 -10-23)    Effective December  18, 2014, NCD 190.4 is  retired.   190.5 - Sweat Test CIM 50 -35  The sweat test is an important diagnostic tool in cystic fibrosis and may be covered when used for that purpose.  Usage of the sweat test as a predictor of efficacy of sympathectomy in peripheral vascular disease is unproven and, therefore, is not covered.  190.6 - Hair Analysis (Rev. 1, 10-03-03) CIM 50 -24  Not Covered  Hair analysis to detect mineral traces as an aid in diagnosing human disease is not a covered service under Medicare.
(Medicare National Coverage Determinations Manual)
Not Covered  Hair analysis to detect mineral traces as an aid in diagnosing human disease is not a covered service under Medicare.   The correlation of hair analysis to the chemical state of the whole body is not possible at this time, and therefore this diagnostic procedure cannot be considered to be reasonable and necessary under 1862(a)(1) of the Act.   190.7 - Human Tumor Stem Cell Drug Sensitivity Assays  (Rev. 1, 10-03-03) CIM 50 -41  Human tumor stem cell drug sensitivity assays involve exposure of human tumor stem cell colonies grown in tissue culture to anticancer drugs and observing for cytotoxic effects.  Their purpose is to screen potential anticancer drugs and predict the effects of these drugs on tumors of individual patients, to a llow the selection of the most effective drug or drugs for that patient.  Human tumor drug sensitivity assays are considered experimental, and therefore, not covered under Medicare at this time.  The Fluorescent Cytoprint Assay, a miniaturized organ cultur e system for cancer chemosensitivity testing, allows for qualitative visual estimation of cell kill using low power microscopy and a noncytotoxic fluoresence probe for cell viability.  The clinical application of the assay, based on testing in tumor microorgans rather than in clones derived from single cells, is considered experimental, and therefore, not covered under Medicare at this time.   190.8 - Lymphocyte Mitogen Response Assays (Rev. 1, 10- 03-03) CIM 50 -45  For Services Performed On or After May 16, 1983  The lymphocyte mitogen response assay measures the immune response of patient peripheral blood lymphocytes.  It is a covered test under Medicare when it is medically necessary to assess lymphocytic function in diagnosed in munodeficiency diseases and to monitor immunotherapy.  It is not covered when it is used to monitor the treatment of cancer, because its use for that purpose is experimental.  190.9 - Serologic Testing for Acquired Immunodeficiency Syndrome (AIDS)  (Rev. 1, 10- 03-03) CIM 50 -52
(Medicare National Coverage Determinations Manual)
Serologic testing is employed to detect antibodies to the AIDS virus which is currently identified by the term human immunodeficiency virus (HIV).  The virus originally was named human T -cell lymphotropic virus, type III (HTLV -III), a term that remains  in common usage.   Antibodies may be detected by a variety of immunoassay techniques, the most common being an enzyme -linked immunosorbent assay (ELISA).  When an assay is reactive on initial testing, it should be repeated on the same specimen.  A more spe cific test, (Western blot, immunofluorescent assay) is usually performed following repeatedly reactive ELISA results.   These tests may be covered when performed to help determine a diagnosis for symptomatic patients.  They are not covered when furnished as  part of a screening program for asymptomatic persons.   NOTE:  Two enzyme -linked immunosorbent assay (ELISA) tests that were conducted on the same specimen must both be positive before Medicare will cover the Western blot test.  190.10 - Laboratory Tests - CRD Patients (Rev. 1, 10- 03-03) CIM 50 -17  Laboratory tests are essential to monitor the progress of CRD patients.  The following list and frequencies of tests constitute the level and types of routine laboratory tests that are covered.  Bills for other types of tests are considered nonroutine.  Routine tests at greater frequencies must include medical justification.  Nonroutine tests generally are justified by the diagnosis.  The routinely covered regimen includes the following tests:   Per Dialysis    All h ematocrit or hemoglobin and clotting time tests furnished incident to dialysis treatments.   Per Week    Prothrombin time for patients on anticoagulant therapy, and   Serum Creatinine   Per Week or Thirteen Per Quarter    BUN  Monthly   CBC,   Serum Calcium,   Serum Chloride,  Serum Potassium,   Serum Bicarbonate,   Serum Phosphorous,  Total Protein,   Serum Albumin,  Alkaline Phospatase,   AST,   SGOT, and   LDH.   Guidelines for tests other than those routinely performed include:    Serum Aluminum -  one every 3 months, and   Serum Ferritin -  one every 3 months
(Medicare National Coverage Determinations Manual)
Guidelines for tests other than those routinely performed include:    Serum Aluminum -  one every 3 months, and   Serum Ferritin -  one every 3 months   The following tests for hepatitis B are covered when patients first enter a dialysis facility: hepatitis B surface antigen (HBsAg) and Anti -HBs.  Coverage of future testing in these patients depends on their serologic stat us and on whether they have been successfully immunized against hepatitis B virus.  The following table summarizes the frequency of serologic surveillance for hepatitis B.  Tests furnished according to this table do not require additional documentation and are paid separately because payment for maintenance dialysis treatments does not take them into account.  FREQUENCY OF SCREENING    Vaccination and Serologic Status  HbsAg Patients  Anti -HBs Patients  Unvaccinated  Susceptible  Monthly  Semiannually  Unvaccinated  HBsAg Carrier  Annually  None  Unvaccinated  Anti-HBs-Positive (1)  None  Annually  Vaccinated  Anti-HBs-Positive (1)  None  Annually  Vaccinated  Low Level or No Anti -HBs Monthly  Semiannually   (1) At least 10 sample ration units by radioimmunoassay or positive by enzyme immunoassay.  Patients who are in the process of receiving hepatitis B vaccines, but have not received the complete series, should continue to be routinely screened as susceptible.  Between one and six months after the third dose, all vaccines should be tested for anti -HBs to confirm their response to the vaccine.   Patients who have a level of anti -HBs of at least 10 sample ratio units (SRUs) by radioimmunoassay (RIA) or who are positive by enzyme immunoassay (EIA) are  considered adequate responders to vaccine and need only be tested for anti -HBs annually to verify their immune status.  If anti -HBs drops below 10 SRUs by RIA or is negative by EIA, a booster dose of hepatitis B vaccine should be given.  Laboratory tests are subject to the normal coverage requirements.  If the laboratory services are performed by a free- standing facility, the facility must meet the conditions of coverage for independent laboratories.
(Medicare National Coverage Determinations Manual)
190.11 - Home Prothrombin Time/Interna tional Normalized Ratio (PT/INR) Monitoring for Anticoagulation Management  Effective March 19, 2008  (Rev. 90, Issued: 07-25- 08, Effective: 03 -19-08, Implementation: 08-25-08)   A. General   Use of the International Normalized Ratio (INR) or prothrombin time (PT) - standard measurement for reporting the bloods clotting time) - allows physicians to determine the level of anticoagulation in a patient independent of the laboratory reagents used.  The INR is the ratio of the patients PT (extrinsic or tissue -factor dependent coagulation pathway) compared to the mean PT for a group of normal individuals.  Maintaining patients within his/her prescribed therapeutic range minimizes adverse events associated with inadequate or excessive anticoagulation such as serious bleeding or thromboembolic events.  Patient self -testing and self-management through the use of a home INR monitor may be used to improve the time in therapeutic rate (TTR) for select groups of patients.  Increased TTR leads to improved clinical outcomes and reductions in thromboembolic and hemorrhagic events.   Warfarin (also prescribed under other trade names, e.g., Coumadin) is a self-administered, oral anticoagulant (blood thinner) medi cation that affects the vitamin K -dependent clotting factors II, VII, IX and X.  It is widely used for various medical conditions, and has a narrow therapeutic index, meaning it is a drug with less than a 2-fold difference between median lethal dose and median effective dose.  For this reason, since October 4, 2006, it falls under the category of a Food and Drug Administration (FDA) black -box drug whose dosage must be closely monitored to avoid serious complications.  A PT/INR monitoring system is a porta ble testing device that includes a finger-stick and an FDA- cleared meter that measures the time it takes for a persons blood plasma to clot.  B. Nationally Covered Indications
(Medicare National Coverage Determinations Manual)
For services furnished on or after March 19, 2008, Medicare will cover the use of home PT/INR monitoring for chronic, oral anticoagulation management for patients with mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism (inclusive of  deep venous thrombosis and pulmonary embolism) on warfarin.  The monito r and the home testing must be prescribed by a treating physician as provided at 42 CFR 410.32(a), and all of the following requirements must be met:   1. The patient must have been anticoagulated for at least 3 months prior to use of the home INR device; and ,  2. The patient must undergo a face- to-face educational program on anticoagulation management and must have demonstrated the correct use of the device prior to its use in the home; and,   3. The patient continues to correctly use the device in the context of t he management of the anticoagulation therapy following the initiation of home monitoring; and,  4. Self-testing with the device should not occur more frequently than once a week.   C. Nationally Non -Covered Indications   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
(Medicare National Coverage Determinations 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.
(Medicare National Coverage Determinations Manual)
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).
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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)
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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