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April 2024
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CMS Transmittals

National Coverage Determination
Procedure Code: 8XXXX
Fecal Occult Blood Test
CMS Policy Number: 190.34
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Description: The Fecal Occult Blood Test (FOBT) detects the presence of trace amounts of blood in stool. The procedure is performed by testing one or several small samples of one, two or three different stool specimens.

This test may be performed with or without evidence of iron deficiency anemia, which may be related to gastrointestinal blood loss. The range of causes for blood loss include inflammatory causes, including acid-peptic disease, non-steroidal anti-inflammatory drug use, hiatal hernia, Crohn’s disease, ulcerative colitis, gastroenteritis, and colon ulcers. It is also seen with infectious causes, including hookworm, strongyloides, ascariasis, tuberculosis, and enteroamebiasis. Vascular causes include angiodysplasia, hemangiomas, varices, blue rubber bleb nevus syndrome, and watermelon stomach. Tumors and neoplastic causes include lymphoma, leiomyosarcoma, lipomas, adenocarcinoma and primary and secondary metastases to the GI tract. Drugs such as nonsteroidal anti-inflammatory drugs also cause bleeding. There are extra gastrointestinal causes such as hemoptysis, epistaxis, and oropharyngeal bleeding. Artifactual causes include hematuria, and menstrual bleeding. In addition, there may be other causes such as coagulopathies, gastrostomy tubes or other appliances, factitial causes, and long distance running.

Three basic types of fecal hemoglobin assays exist, each directed at a different component of the hemoglobin molecule.
1. Immunoassays recognize antigenic sites on the globin portion and are least affected by diet or proximal gut bleeding, but the antigen may be destroyed by fecal flora.
2. The heme-porphyrin assay measures heme-derived porphyrin and is least influenced by enterocolic metabolism or fecal storage. This assay does not discriminate dietary from endogenous heme. The capacity to detect proximal gut bleeding reduces its specificity for colorectal cancer screening but makes it more useful for evaluating overall GI bleeding in case finding for iron deficiency anemia.
3. The guaiac-based test is the most widely used. It requires the peroxidase activity of an intact heme moiety to be reactive. Positivity rates fall with storage. Fecal hydration such as adding a drop of water increases the test reactivity but also increases false positivity.

Of these three tests, the guaiac-based test is the most sensitive for detecting lower bowel bleeding. Because of this sensitivity, it is advisable, when it is used for screening, to defer the guaiac-based test if other studies of the colon are performed prior to the test. Similarly, this test’s sensitivity may result in a false positive if the patient has recently ingested meat. Both of these cautions are appropriate when the test is used for screening, but when appropriate indications are present, the test should be done despite its limitations.

1. To evaluate known or suspected alimentary tract conditions that might cause bleeding into the intestinal tract.
2. To evaluate unexpected anemia.
3. To evaluate abnormal signs, symptoms, or complaints that might be associated with loss of blood.
4. To evaluate patient complaints of black or red-tinged stools.

1. The FOBT is reported once for the testing of up to three separate specimens (comprising either one or two tests per specimen).
2. In patients who are taking non-steroidal anti-inflammatory drugs and have a history of gastrointestinal bleeding but no other signs, symptoms, or complaints associated with gastrointestinal blood loss, testing for occult blood may generally be appropriate no more than once every three months.

When testing is done for the purpose of screening for colorectal cancer in the absence of signs, symptoms, conditions, or complaints associated with gastrointestinal blood loss, report the HCPCS code for colorectal cancer screening; fecal-occult blood test, 1-3 simultaneous determinations should be used.

Frequency Limitations: Patients who are taking non-steroidal anti-inflammatory drugs and have a history of GI bleeding but no other signs, symptoms, or complaints associated with GI blood loss: once every 3 months

To review all requirements of this policy, please see: CMS NCD listing by Chapter

Covered ICD-10 Codes.

A02.0Salmonella enteritis
A02.1Salmonella sepsis
A03.0Shigellosis due to Shigella dysenteriae
A03.1Shigellosis due to Shigella flexneri
A03.2Shigellosis due to Shigella boydii
A03.3Shigellosis due to Shigella sonnei
A03.8Other shigellosis
A03.9Shigellosis, unspecified
A04.5Campylobacter enteritis
A04.6Enteritis due to Yersinia enterocolitica
.... and many more.

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