evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
When monitoring long- term anti- lipid dietary or pharmacologic therapy and when following patients with borderline high total or LDL cholesterol levels, it may be reasonable to perform the lipid panel  annually.  A lipid panel at a yearly interval will usually be adequate while measurement of the serum total cholesterol or a measured LDL should suffice for interim visits if the patient does not have hypertriglyceridemia.  Any one component of the panel or a measured LDL may be reasonable and necessary up to six times the first year for monitoring dietary or pharmacologic therapy.  More frequent total cholesterol, HDL cholesterol, LDL cholesterol and triglyceride testing may be indicated for marked elevat ions or for changes to anti -lipid therapy due to inadequate initial patient response to dietary or pharmacologic therapy.  The LDL cholesterol or total cholesterol may be measured three times yearly after treatment goals have been achieved.   Electrophoreti c or other quantitation of lipoproteins may be indicated if the patient has a primary disorder of lipoid metabolism.   Effective January 1, 2005, the Medicare law expanded coverage to cardiovascular screening services.  Several of the procedures included in this NCD may be covered for screening purposes subject to specified frequencies.  See 42 CFR 410.17 and section 100, chapter 18, of the Claims Processing Manual, for a full description of this benefit.   Limitations   Lipid panel and hepatic panel testing m ay be used for patients with severe psoriasis which has not responded to conventional therapy and for which the retinoid etretinate has been prescribed and who have developed hyperlipidemia or hepatic toxicity.  Specific examples include erythrodermia and generalized pustular type and psoriasis associated with arthritis.   Routine screening and prophylactic testing for lipid disorder are not covered by Medicare.  While lipid screening may be medically appropriate, Medicare by statute does not pay for it.  Li pid testing in asymptomatic individuals is considered to be screening regardless of the presence of other risk factors such as family history, tobacco use, etc.   Once a diagnosis is established, one or several specific tests are usually adequate for monitoring the course of the disease.  Less specific diagnoses (for example, other chest pain) alone do not support medical necessity of these tests.
(Medicare National Coverage Determinations Manual)
Once a diagnosis is established, one or several specific tests are usually adequate for monitoring the course of the disease.  Less specific diagnoses (for example, other chest pain) alone do not support medical necessity of these tests.  When monitoring long- term anti- lipid dietary of pharmacologic therapy and when following patients with borderline high total or LDL cholesterol levels, it is reasonable to perform the lipid panel annually.  A lipid panel at a yearly interval will usually be adequate while measurement of the serum total cholesterol or a measured LDL should suffice for interim visits if the patient does not have hypertriglyceridemia.   Any one component of the panel or a measured LDL may be medically necessary up to six times the first year for monitoring dietary or pharmacologic therapy.  More frequent total cholesterol, HDL cho lesterol, LDL cholesterol and triglyceride testing may be indicated for marked elevations or for changes to anti -lipid therapy due to inadequate initial patient response to dietary or pharmacologic therapy.  The LDL cholesterol or total cholesterol may be measured three times yearly after treatment goals have been achieved.   If no dietary or pharmacologic therapy is advised, monitoring is not necessary.  When evaluating non- specific chronic abnormalities of the liver (for example, elevations of transaminase, alkaline phosphatase, abnormal imaging studies, etc.), a lipid panel would generally not be indicated more than twice per year.   190.24 - Digoxin Therapeutic Drug Assay  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  A digoxin therapeutic drug assay is useful for diagnosis and prevention of digoxin toxicity and/or prevention for under dosage of digoxin.  Indications   Digoxin levels may be performed to monitor drugs levels of individuals receiving digoxin therapy because the margin of safety between side effects and toxicity is narrow or because the blood level may not be high enough to achieve the desired clinical effect.   Clinical indications may include individuals on digoxin:    With symptoms, signs or electrocardiogram (ECG) suggestive of digoxin toxicity   Taking medications that influence absorption, bioavailability, distribution, and/or elimination of digoxin
(Medicare National Coverage Determinations Manual)
 With symptoms, signs or electrocardiogram (ECG) suggestive of digoxin toxicity   Taking medications that influence absorption, bioavailability, distribution, and/or elimination of digoxin    With impaired renal, hepatic, gastrointestinal, or thyroid function   With pH and/or electrolyte abnormalities    With unstable cardiovascular status, including myocarditis    Requiring monitoring of patient compliance   Clinical indication may include individuals:   Suspected of accidental or intended overdose    Who have an accep table cardiac diagnosis and for whom an accurate history of use of digoxin is unobtainable   The value of obtaining regular serum digoxin levels is uncertain, but it may be reasonable to check levels once yearly after a steady state is achieved.  In additio n, it may be reasonable to check the level if:    Heart failure status worsens    Renal function deteriorates    Additional medications are added that could affect the digoxin level    Signs or symptoms of toxicity develop  Steady state will be reached in approximately 1 week in patients with normal renal function, although 2- 3 weeks may be needed in patients with renal impairment.  After changes in dosages or the addition of a medication that could affect the digoxin level, it is reasonable to check the di goxin level one week after the change or addition.  Based on the clinical situation, in cases of digoxin toxicity, testing may need to be done more than once a week.   Digoxin is indicated for the treatment of patients with heart failure due to systolic dysfunction and for reduction of the ventricular response in patients with atrial fibrillation of flutter.  Digoxin may also be indicated for the treatment of other supraventricular arrhythmias, particularly in the presence of heart failure.   Limitations   This test is not appropriate for patients on digitoxin or treated with digoxin FAB (fragment antigen binding) antibody.  190.25 - Alpha-fetoprotein  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Alpha -fetoprotein (AFP) is  a polysaccharide found in some carcinomas.  It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy.   Indications
(Medicare National Coverage Determinations Manual)
Alpha -fetoprotein (AFP) is  a polysaccharide found in some carcinomas.  It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy.   Indications   The AFP is useful for the diagnosis of hepatocellular carcinoma in high- risk patients (such a s alcoholic cirrhosis, cirrhosis of viral etiology, hemochromatosis, and alpha 1-antitrypsin deficiency) and in separating patients with benign hepatocellular neoplasms or metastases from those with hepatocellular carcinoma and, as a non -specific tumor associated antigen, serves in marking germ cell neoplasms of the testis, ovary, retroperitoneum, and mediastinum.   190.26 - Carcinoembryonic Antigen  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Carcinoembryonic antigen (CEA) is a protein polysaccharide found in some carcinomas.  It is effective as a biochemical marker for monitoring the response of certain malignancies to therapy.   Indications   The CEA may be medically necessary for follow -up of patients with colorectal carcinoma.  It would however only be medically necessary at treatment decision- making points.  In some clinical situations (e.g., adenocarcinoma of the lung, small cell carcinoma of the lung, and some gastrointestinal carcinomas) w hen a more specific marker is not expressed by the tumor, CEA may be a medically necessary alternative marker for monitoring.  Preoperative CEA may also be helpful in determining the post -operative adequacy of surgical resection and subsequent medical management.  In general, a single tumor marker will suffice in following patients with colorectal carcinoma or other malignancies that express such tumor markers.   In following patients who have had treatment for colorectal carcinoma, ASCO guideline suggests t hat if resection of liver metastasis would be indicated, it is recommended that post-operative CEA testing be performed every two to three months in patients with initial stage II or stage III disease for at least two years after diagnosis.
(Medicare National Coverage Determinations Manual)
For patients w ith metastatic solid tumors, which express CEA, CEA may be measured at the start of the treatment and with subsequent treatment cycles to assess the tumors response to therapy.   Limitations   Serum CEA determinations are generally not indicated more freque ntly than once per chemotherapy treatment cycle for patients with metastatic solid tumors which express CEA or every two months post -surgical treatment for patients who have had colorectal carcinoma.  However, it may be proper to order the test more freque ntly in certain situation, for example, when there has been a significant change from prior CEA level or a significant change in patient status which could reflect disease progression or recurrence.   Testing with a diagnosis of an in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.   190.27 - Human Chorionic Gonadotropin  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Human Chorionic Gonadotropin (hCG) is useful for monitoring and diagnosis of germ cell neoplasms of the ovary, testis, mediastinum, retroperitoneum, and central nervous system.  In addition, hCG is useful for monitoring pregnant patients with vaginal bleeding, hypertension and/or suspected fetal loss.  It is not reasonable and necessary to perform hCG testing more than once per month for diagnostic purposes.  It may be performed as needed for monitoring of patient progress and treatment.  Qualitative hCG assays are not appropriate for medically managing patients with known or suspected germ cell neoplasms.  190.28 - Tumor Antigen by Immunoassay - CA 125 (Rev. 47, Issued: 02- 24-06, Effective: 01 -01-06, Implementation: 01- 03-06)  Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers.  When elevated, serum concentration of these markers may reflect tumor size and grade.   This policy specifically addresses tumor antigen CA 125.  Indications
(Medicare National Coverage Determinations Manual)
Immunoassay determinations of the serum levels of certain proteins or carbohydrates serve as tumor markers.  When elevated, serum concentration of these markers may reflect tumor size and grade.   This policy specifically addresses tumor antigen CA 125.  Indications   The CA 125 is a high molecular weight serum tumor marker elevated in 80 percent of patients who present with epithelial ovarian carcinoma.  It is also elevated in carcinomas of the fallopian tube, endometrium, and endocervix.  An elevated level may also be associated with the pr esence of a malignant mesothelioma or  primary peritoneal carcinoma.   A CA 125 level may be obtained as part of the initial pre -operative work- up for women presenting with a suspicious pelvic mass to be used as a baseline for purposes of post -operative monitoring.  Initial declines in CA 125 after initial surgery and/or chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels during the first month post treatment to determine the patients CA 125 half -life, whic h has significant prognostic implications.  The CA 125 levels are again obtained at the completion of chemotherapy as an index of residual disease.  Surveillance CA 125 measurements are generally obtained every 3 months for 2 years, every 6 months for the next 3 years, and yearly thereafter.  CA 125 levels are also an important indicator of a patients response to therapy in the presence of advanced or recurrent disease.  In this setting, CA 125 levels may be obtained prior to each treatment cycle.   Limitat ions  These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy.  The service may be ordered at times necessary to assess either the presence of recurrent disease or the patients response to treatment wi th subsequent treatment cycles.   The CA 125 is specifically not covered for aiding in the differential diagnosis of patients with a pelvic mass as the sensitivity and specificity of the test is not sufficient.  In general, a single tumor marker will suff ice in following a patient with one of these malignancies.   (This NCD last reviewed November 2005)   190.29 - Tumor Antigen by Immunoassay CA 15 -3/CA 27.29  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110
(Medicare National Coverage Determinations Manual)
190.29 - Tumor Antigen by Immunoassay CA 15 -3/CA 27.29  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Immunoassay dete rminations of the serum levels of certain proteins or carbohydrates serve as tumor markers.  When elevated, serum concentration of these markers may reflect tumor size and grade.  This policy specifically addresses the following tumor antigens:  CA 15/3 and CA 27.29  Indications   Multiple tumor markers are available for monitoring the response of certain malignancies to therapy and assessing whether residual tumor exists post -surgical therapy.   CA 15 -3 is often medically necessary to aid in the management of patients with breast cancer.  Serial testing must be used in conjunction with other clinical methods for monitoring breast cancer.  For monitoring, if necessary, use consistently either CA 15- 3 or CA 27.29, not both.  CA 27.29 is equivalent t o CA 15- 3 in its usage in management of patients with breast cancer.   Limitations   These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy.  The service may be ordered at time necessary to assess either  the presence of recurrent disease or the patients response to treatment with subsequent treatment cycles.   190.30 - Tumor Antigen by Immunoassay CA 19 -9 (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Immunoassay dete rminations of the serum levels of certain proteins or carbohydrates serve as tumor markers.  When elevated, serum concentration of these markers may reflect tumor size and grade.  This policy specifically addresses the following tumor antigen:  CA 19- 9.  Indications   Multiple tumor markers are available for monitoring the response of certain malignancies to therapy and assessing whether residual tumor exists post -surgical therapy.   Levels are useful in following the course of patients with established diagnosis of pancreatic and biliary ductal carcinoma.  The test is not indicated for diagnosing these two diseases.   Limitations   These services are not covered for the evaluation of patients with signs or symptoms suggestive of malignancy.  The service may be ordered at times necessary to assess either the presence of recurrent disease or the patients response to treatment with subsequent treatment cycles.
(Medicare National Coverage Determinations Manual)
190.31 - Prostate Specific Antigen  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Prostate Specific Antigen (PSA), a tumor marker for adenocarcinoma of the prostate, can predict residual tumor in the post -operative phase of prostate cancer.  Three to six months after radical prostatectomy, PSA is reported to provide a sensitive indicator of persistent disease.  Six months following introduction of antiandrogen therapy, PSA is reported as capable of distinguishing patients with favorable response form those in whom limited response is anticipated.   The PSA when used in conjunction with ot her prostate cancer tests, such as digital rectal examination, may assist in the decision making process for diagnosing prostate cancer, PSA also, serves as a marker in following the progress of most prostate tumors once a diagnosis has been established.  This test is also an aid in the management of prostate cancer patients and in detecting metastatic or persistent disease in patients following treatment.   Indications   The PSA is of proven value in differentiating benign from malignant disease in men with lower urinary tract signs and symptoms (e.g., hematuria, slow urine stream, hesitancy, urgency, frequency, nocturia and incontinence) as well as with patients with palpably abnormal prostate glands on physician exam, and in patients with other laboratory or imaging studies that suggest the possibility of a malignant prostate disorder.  PSA is also a marker used to follow the progress of prostate cancer once a diagnosis has been established, such as in detecting metastatic or persistent disease in patients w ho may require additional treatment.  PSA testing may also be useful in the differential diagnosis of men presenting with as yet undiagnosed disseminated metastatic disease.   Limitations   Generally, for patients with lower urinary tract signs or symptoms, the test is performed only once per year unless there is a change in the patients medical condition.   Testing with a diagnosis of in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.
(Medicare National Coverage Determinations Manual)
Testing with a diagnosis of in situ carcinoma is not reasonably done more frequently than once, unless the result is abnormal, in which case the test may be repeated once.   190.32 - Gamma Glutamyl Transferase  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  Gamma glutamyltransferase (GGT) is an intracellular enzyme that appears in blood following leakage from cells.  Renal tubules, liver, and pancreas contain high amounts, although the measurement of GGT serum is almost always used for assessment of hepatobiliary function.  Unlike other enzymes, which are found in heart, skeletal muscle, and intestinal mucosa as well as l iver, the appearance of an elevated level of GGT is serum is almost always the result of liver disease or injury.  It is specifically useful to differentiate elevated alkaline phosphatase level when the source of the alkaline phosphatase increase (bone, li ver, or placenta) is unclear.  The combination of high alkaline phosphatase and a normal GGT does not, however, rule out liver disease completely.   As well as being a very specific marker of hepatobiliary function, GGT is also a very sensitive marker for h epatocellular damage.  Abnormal concentrations typically appear before elevations of other liver enzymes or bilirubin are evident.  Obstruction of the biliary tract, viral infection (e.g., hepatitis, mononucleosis), metastatic cancer, exposure to hepatotoxins (e.g., organic cimetidine, barbiturates, phenytoin, and carbamazepine) all can cause a moderate to marked increase in GGT serum concentration.  In addition, some drugs can cause or exacerbate liver dysfunction (e.g., atorvastatin, troglitazone, and others as noted in FDA Contraindications and Warning.)   The GGT is useful for diagnosis of liver disease or injury, exclusion of hepatobiliary involvement related to other disease, and patient management during the resolution of existing disease or following injury.  Indications   1. To provide information about known or suspected hepatobiliary disease, for example:   a. Following chronic alcohol or drug ingestion
(Medicare National Coverage Determinations Manual)
1. To provide information about known or suspected hepatobiliary disease, for example:   a. Following chronic alcohol or drug ingestion  b. Following exposure to hepatotoxins   c. When using medication known to have a potential for causing liver toxicity (e.g., following the drug manufacturers recommendations)   d. Following infection (e.g., viral hepatitis and other specific infections such as amebiasis, tuberculosis, psittacosis, and similar infections)   2. To assess liver injury/function following diagnosis of primary or secondary malignant neoplasms   3. To assess liver injury/function in a wide variety of disorders and diseases known to cause liver involvement (e.g., diabetes mellitus, malnutrition, disorders of iron and mine ral metabolism, sarcoidosis, amyloidosis, lupus and hypertension)   4. To assess liver function related to gastrointestinal disease   5. To assess liver function related to pancreatic disease  6. To assess liver function in patients subsequent to liver transplantation   7. To differentiate between the different sources of elevated alkaline phosphatase activity   Limitations   When used to assess liver dysfunction secondary to existing non- hepatobiliary disease with no change in signs, symptoms, or treatment, it is generally not necessary to repeat a GGT determination after a normal result has been obtained unless new indications are present.   If the GGT is the only liver enzyme abnormally high, it is generally not necessary to pursue further evaluation for liver disease for this specific indication.   When used to determine if other abnormal enzyme tests reflect liver abnormality rather than other tissue, it generally is not necessary to repeat a GGT more than one time per week.   Because of the extreme sensitivity of GGT as a marker for cytochrome oxidase induction or cell membrane permeability, it is generally not useful in monitoring patients with known liver disease.   190.33 - Hepatitis Panel/Acute Hepatitis Panel  (Rev. 17, Issued: 07- 02-04) (Effective/Implementation: Not Applicable) PM AB -02-110  This panel consists of the following tests:    Hepatitis A antibody (HAAb), IgM antibody;    Hepatitis B core antibody (HBcAb), IgM antibody;    Hepatitis B surface antigen (HBsAg) and;    Hepatitis C antibo dy;
(Medicare National Coverage Determinations Manual)
 Hepatitis A antibody (HAAb), IgM antibody;    Hepatitis B core antibody (HBcAb), IgM antibody;    Hepatitis B surface antigen (HBsAg) and;    Hepatitis C antibo dy;  Hepatitis is an inflammation of the liver resulting from viruses, drugs, toxins, and other etiologies.  Viral hepatitis can be due to one of at least five different viruses, designated hepatitis A, B, C, and E.  Most cases are caused by hepatitis A vi rus (HAV), hepatitis B virus (HBV), or hepatitis C virus, (HCV).   The HAV is the most common cause of hepatitis in children and adolescents in the United States.  Prior exposure is indicated by a positive IgG anti -HAV.  Acute HAV is diagnosed by IgM anti -HAV, which typically appears within four weeks of exposure, and which disappears within three months of its appearance.  IgG anti -HAV is similar in the timing of its appearance, but it persists indefinitely.  Its detection indicates prior effective immuniza tion or recovery form infection.  Although HAV is spread most commonly by fecal -oral exposure, standard immune globulin may be effective as a prophylaxis.