evekhm/cms_iom_500 huggingface dataset:
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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.
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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).
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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).
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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
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 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.
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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.
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 A woman of childbearing age is one who is premenopausal and has been determined by a physician or other qualified pr actitioner to be of ch ildbearing age, based upon the medical history or other findings.   Other qualified practitioner, as defined in 42 CFR 410.56(a)  includes a certified nurse midwife (as defined in 1861(gg ) of the Act), or a physician assistant, nurse practitioner, or clinical nu rse specialist (as defined in 1861(aa) of the Act) who is authorized under State law to perform the examination.  Screening Pelvic Examination  Section 4102 of the Balanced Budget Act of  1997 provides for coverage of screening pelvic examinations (including a clinical breast examination) for all female beneficiaries, subject to certain frequency and other lim itations.  A screening pelvic examination (including a clinical breast ex amination) should include at least seven of the following eleven elements:   Inspection and palpation of breasts for masses or lumps, tenderness, symmetry, or nipple discharge.   Digital rectal examination including sphincter tone, presence of hemorrhoids, and rectal masses.  Pelvic examination (with or  without specimen collection for smears and cultures) including:   External genitalia (for exam ple, general appearance, hair  distribution, or lesions).   Urethral meatus (for example, size,  location, lesions, or prolapse).   Urethra (for example, masses, tenderness, or scarring).   Bladder (for example, fullness, masses, or tenderness).   Vagina (for example, general appearan ce, estrogen effect, discharge lesions, pelvic support, cystoc ele, or rectocele).   Cervix (for example, general a ppearance, lesions, or discharge).   Uterus (for example, size, contour, position, mobility, tenderness, consistency, descent, or support).   Adnexa/parametria (for example, ma sses, tenderness, organomegaly, or nodularity).   Anus and perineum.  This description is from Documentation Guidelines for Evaluation and Management Services, published in May 1997 and was de veloped by the Centers for Medicare & Medicaid Services and the Am erican Medical Association.
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 Anus and perineum.  This description is from Documentation Guidelines for Evaluation and Management Services, published in May 1997 and was de veloped by the Centers for Medicare & Medicaid Services and the Am erican Medical Association.  230.8 - Non-Implantable Pelvic Floor  Electri cal Stimulator  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 60-24  Non-im plantable pelvic f loor electrical stim ulators provide neurom uscular electrical stimulation through the pelvic floor with the intent of strengthening and exercising pelvic floor m usculature. S timulation is generally delivered by vaginal or anal probes connected to an extern al puls e generator.  The m ethods of  pelvic f loor ele ctrical stim ulation vary in location, stim ulus frequency (Hz), stim ulus intens ity or am plitude  (mA) , pulse duration (duty cycle), treatm ents per day, num ber of treatm ent days per week, length of  time for each treatm ent session, overall tim e period for device use and between clinic and hom e settings.  In general, the stimulus frequency and other parameters ar e cho sen based on  the patients clin ical diagnosis.  Pelvic floor electrical stimul ation with a non-im plantable stimulator is covered for the treatment of  stres s and/o r urge urin ary incontinen ce in cogn itively in tact p atients who have failed a docum ented trial of pelv ic muscle exercis e (PME) training.  A failed trial of PME training is defined as  no clin ically sign ificant im provem ent in urinary continence after com pleting 4 weeks of an ordered plan of pelvic muscle exercises designed to increase p eriurethral m uscle streng th.  230.19 - Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 45-32
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Carnitine is a naturally occurring substance that f unctions in the transport of the long-chain fatty acids for energy production by th e body. Deficiency can occur due to a congenital defect in synthesis or utilizati on, or fro m dialysis. Th e causes of carnitine deficiency in hem odialysis patients include  dialy tic loss, r educed renal synthesis and reduced d ietary in take.   Intrav enous levocarnitin e, for one of the fo llowin g indication s, will only be covered f or those ESRD patients who have been on di alysis for a m inimum of three months. Patien ts must have docu mented carnitin e def iciency, def ined as a plasm a free carn itine level < 40 microm ol/L (d eterm ined by a professio nally accepted m ethod as recognized  in curren t literature), along  with signs a nd sym ptoms of :   Erythropoietin -resis tant anem ia (persisten t hematocrit  < 30 p ercent with treatm ent) that has not responded to standa rd erthropoietin dosage (that which is considered clinically appropriate  to treat the particular patient) with iron replacement, and for which other causes have been inves tigated and adequately treated, or   Hypotension  on hemodialysis that interferes with  delivery of the intended dialysis despite application of usual measures deemed  appropriate (e.g., fluid management). Such episodes of hypotension must have  occurred during at least 2 dialysis treatments in a 30-day period.  Continued use of levocarnitine will not be covered if improvement has not been demonstrated within 6 months of initiati on of treatment. All other indications for levocarnitine are noncovered in the ESRD population.  For a patient currently receiving intrave nous levocarnitine, Medicare will cover continued treatment if:
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For a patient currently receiving intrave nous levocarnitine, Medicare will cover continued treatment if:   Levocarnitine has been administered to treat erythropoietin-resistent anemia (persistent hematocrit < 30 per cent with treatment) that has not responded to standard erythropoietin dosage (that which is consider ed clinically appropriate to treat the particular patient) with iron replacement,  and for which other causes have been investigated and adequately treated, or hypotension on hemodialysis th at interferes with delivery of the intended dialysis despite  application of usual measures deemed appropriate (e.g., fluid management) and su ch episodes of hypotension occur during at least 2 dialysis treatments  in a 30-day period; and   The patients medical record documents a pre-dialysis plasma free carnitine level < 40 micromol/L prior to the initiation of treatment; or   The treating physician certifies (documents in the medical record) that in his/her judgment, if treatment with th e levocarnitine is discontinued,  the patients pre-dialysis carnitine level would fall below 40 micromo l/L and the patient would have recurrent erythropoietin-resistant-anemia or intradialytic hypotension.  260.1 - Adult Liver Transplantation  (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 35-53  A.   General   Effective July 15, 1996, adult liver transplant ation when performed on beneficiaries with end stage liver disease other than hepatitis B or malignancies is covered under Medicare when performed in a facility which is approved by CMS as meeting institutional coverage criteria.  Effective December 10, 1999, adult liver transp lantation when performed on beneficiaries with end stage liver disease other than malignancies is covered under Medicare when perform ed in a facility which is approved by CMS as m eeting institutional coverage criteria.   Effective Septem ber 1, 2001, Medicare c overs adult liver tr ansplantation f or hepatoce llular ca rcinom a when the f ollowing co nditions are m et:
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Effective Septem ber 1, 2001, Medicare c overs adult liver tr ansplantation f or hepatoce llular ca rcinom a when the f ollowing co nditions are m et:   The patien t is not a cand idate for subtotal live r resection ;  The patien ts tumor(s) is  less th an or equal to 5 c m in diam eter;  There is no m acrovascular invo lvement;  There is no identifiable extrahepatic spr ead of tumor to surrounding lym ph nodes, lungs, abdom inal organs or bone; and  The transp lant is f urnish ed in a f acility tha t is ap proved by CMS as m eeting institutional coverage criteria for liver transplants (see 65 FR 15006).    Adult liv er transplan tation for other m alignancies rem ains excluded from  coverage. Coverage of adult liver transplantation is e ffective as of the date  of the facility s approval, but for applications received before  July 13, 1991, can be effective as early as March 8, 1990.  (See F ederal Regist er 56 FR 15006 dated April 12, 1991.)  B.   Follow -Up Care  Follow-up care or retransplantation required as a result of a covered liver transp lant is covered, p rovided such s ervices are o therw ise reasonable and necessary.  Follow-up care is also covered for patients who have been disch arged from a hospita l after rece iving noncovered liver transplant.  Coverage for fo llow-up care is for item s and services that are reasonable and necessary as determ ined by M edicare guidelines.    C.   Immunosuppressive Drugs  See the Med icare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 50.5. 1 and the Medicare  Claim s Processing Manual, Chapter 17, Drugs and Biologicals,  80.3.  300.1 - Obsolete or Unreliable Diagnostic Tests (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 50-34  A.   Diagno stic Tests
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300.1 - Obsolete or Unreliable Diagnostic Tests (Rev. 48, Issued:  03-17-06; Effectiv e/Implementation Dates:  06-19-06) CIM 50-34  A.   Diagno stic Tests   Do not routinely pay for the followin g diagnosti c tests b ecause they are o bsolete and have been replaced by m ore advanced procedures.  The listed tests m ay be paid for only if the medical need for the procedure is satisfactorily jus tified by the physician who perform s it.  When the se rvices are su bject to the Qua lity Im provem ent Organiza tion ( QIO) Review, the QIO is responsible for determ ining that satisfactory m edical jus tification exists.    When the services are no t subject to QIO Review, the in termediary or carrier is responsible for determ ining that satisfactory m edical justification exis ts.  This includes: