(Medicare National Coverage Determinations Manual)

A diagnostic pap smear and related medically necessary services are covered under Medicare Part B when ordered by a physician under one of the following conditions:    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.   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  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   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.   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  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  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