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190.2 - Diagnostic Pap Smears  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 50-20, CIM 50-20.1  A diagnostic pap smear and related medica lly necessary services are covered under Medicare Part B when ordered by a physician under one of the following conditions:   Previous cancer of the cervix, uterus, or va gina 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 patien t 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.)  190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis) (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) PM AB-02-100  Diagnosis of HIV infection is primarily made  through the use of serologic assays. These assays take one of two forms: antibody dete ction assays and specific HIV antigen (p24) procedures.  The antibody assays are usually  enzyme immunoassays (EIA), which are 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 use method is the Western Blot.  The HIV-1 core antigen (p24) test detects ci rculating viral antigen which may be found prior to the development of antibodies and may al so be present in later stages of illness in the form of recurrent or persistent antigenem ia.  Its prognostic utility  in HIV infection has been diminished as a result of development of sensitive viral RNA assays, and its primary use today is as a routine screeni ng tool in potential blood donors.  In several unique situations, serologic tes ting alone may not reliably establish an HIV infection. This may occur because the anti body response (particularly the IgG response detected by Western Blot) has not yet develope d (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 of 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 es tablish 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 mo re of the following clinical findings:  1. The patient has a documented, otherwis e unexplained, AIDS-defining or AIDS-associated opportunistic infection.  2. The patient has another documented sexually transmitted disease, which identifies significant risk of exposure to HIV and the poten tial for an early or subclinical infection.  3. The patient has documented acute or chr onic 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-def ining 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, recurr ent, or persistent conditions  which suggest an underlying immune deficiency (for example, cutaneous or mucosal disorders).  7. The patient has otherwise unexplaine d generalized signs and symptoms suggestive of a chronic process with an unde rlying immune deficiency (for example, fever, weight loss, malaise, fatigue, chroni c diarrhea, failure to thrive, chronic cough, hemoptysis, shortness of breath, or lymphadenopathy).  8. The patient has otherwise unexplained la boratory evidence of a chronic disease process with an underlying immune defici ency (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, needlesticks and other significant blood exposures) and antiviral ther apy is initiated or antici pated 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.  HI V-2 testing is indicated if c linical circumstances suggest HIV-2 is likely (that is, compatible clinical finding and HIV-1 te st 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 perfo rmed only after documentation that the initial EIA tests are repeatedly posi tive or equivocal on a single sample.  3. The HIV antigen tests currently ha ve no defined diagnostic usage.  4. Direct viral RNA detection may be perfor med in those situations where serologic testing does not establish a dia gnosis but strong clinical susp icion persists (for example, acute retroviral syndrome, nonspecific serolo gic evidence of HIV, or perinatal HIV infection).  5. If initial serologic tests confirm an HIV in fection, repeat testing is not indicated.  6. If initial serologic tests are HIV EIA negative and there is no 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 us ing serologic methods may be medically appropriate in situations where th ere is a risk of exposure to HIV .  However, in the absence of a documented AIDS defining or HIV -associated disease, an HIV-associated sign or symptom, or documented exposure to a known HIV-infected source, the testing is considered by Medicare to be screening and thus is not covered by Medicare (for example, history of multiple blood component transfusions, exposure to blood or body fluids not resulting in considera tion of therapy, history of tran splant, history of illicit drug use, multiple sexual partners, same-sex encounters, prostitution, or contact with prostitutes).  8. The CPT Editorial Panel has issued a nu mber 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 inve stigational basis.  La boratory providers are advised to remain current on FDA- approved status for these tests.  Medicare National Coverage Determinations Manual Chapter 1, Part 4 (Sections 200  310.1) Coverage Determinations  Table of Contents  (Rev. 48, Issued:  03-17-06; Effec tive/Implementation Dates:  06-19-06)   230.8 - Non-Im plantabale Pelvic  Floor Elecr ical Stim ulator  210.1 - Prostate Cancer Screening Tests  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 50-55  Covered  A.   General  Section 4103 of the Balanced Budget Act of 1997 provides for coverage of certain prostate cancer screening tests subject to  certain coverage, frequency, and payment limitations.  Medicare will cover prostate cance r screening tests/procedures for the early detection of prostate cancer.  Coverage of prostate cance r screening tests includes the following procedures furnished to an individual for the early detection of prostate cancer:   Screening digital rectal examination; and  Screening prostate specific antigen blood test.  B.   Screening Digital Rectal Examinations   Screening digital rectal examinations are c overed at a frequency of once every 12 months for men who have attained age 50 (at least 11 months have passed following the month in which the last Medicare-covered screening di gital rectal examination was performed).  Screening digital rectal examination means a clinical examination of an individuals prostate for nodules or other abnormalities of  the prostate.  This screening must be performed by a doctor of medicine  or osteopathy (as defined in 1861(r)(1)  of the Act), or by a physician assistant, nurse practitioner, clinical nurse specialist, or certified nurse midwife (as defined in 1861(aa) and 1861(gg)  of the Act) who is authorized under State law to perform the examination, fu lly knowledgeable about the beneficiarys medical condition, and would be responsible for using the results of any examination performed in the overall management of th e beneficiarys specific medical problem.   C.   Screening Prostate Specific Antigen Tests    Screening prostate specific antigen tests are covered at a frequency of once every 12 months for men who have attained age 50 (a t least 11 months have passed following the month in which the last Medicare-covered sc reening prostate specific antigen test was performed).  Screening prostate specific antigen tests (PSA) means a test to detect the marker for adenocarcinoma of prostate.  PSA  is a reliable immunocytochemical marker for primary and metastatic adenocarcinoma of prostate.  This screening must be ordered by the beneficiarys physician or by the beneficiarys physician assistant, nurse practitioner, clinical nurse specialist, or  certified nurse midwif e (the term attending physician is defined in 1861(r)(1)  of the Act to mean a doctor of medicine or osteopathy and the terms physicia n assistant, nurse practitioner,  clinical nurse specialist, or certified nurse midwife are defined in 1861(aa) and 1861(gg)  of the Act) who is fully knowledgeable about the beneficiarys medical condition, and who would be responsible for using the results of any examination (test) performed in the overall management of the beneficiar ys specific medical problem.  210.2 - Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or Vaginal Cancer (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 50-20.1  Screening Pap Smear  A screening pap smear and related medically necessary services provided to a woman for the early detection of cervical  cancer (including collection of  the sample of cells and a physicians interpretation of the test results) and pelvic examinati on (including clinical breast examination) are covered under Medica re Part B when ordered by a physician (or authorized practitioner) under one  of the following conditions:   She has not had such a test during the preceding two years or is a woman of childbearing age ( 1861(nn)  of the Act).   There is evidence (on the basis of her medical history or other findings) that she is at high risk of developing cervical cancer and her physician (or authorized practitioner) recommends that she have the test performed more frequently than every two years.  High risk factors for cervi cal and vaginal cancer are:   Early onset of sexual activity  (under 16 years of age)  Multiple sexual partners (five or more in a lifetime)  History of sexually transmitted disease (including HIV infection)   Fewer than three negative or any pap smears within the previous seven years; and  DES (diethylstilbestrol) - exposed daughters of women who took DES during pregnancy.  NOTE: Claims for pap smears must indicate the be neficiarys low or high risk status by including the appropriate ICD-9-CM on the line item (Item 24E of the Form CMS-1500).  Definitions   A woman as described in 1861(nn)  of the Act is a woman who is of childbearing age and has had a pap smear test during any of the preceding three years that indicated the presence of cervical or vagi nal cancer or other abnormality, or is at high risk of developing cervical or vaginal cancer.