Press Releases

MEDICARE ANNOUNCES INTENTION TO COVER SCREENING IMMUNOASSAY FECAL-OCCULT BLOOD TESTS

The Centers for Medicare & Medicaid Services (CMS) today announced its intention to make screening immunoassay fecal-occult blood tests (iFOBTs) available to Medicare beneficiaries age 50 and older.   The new patient-friendly test is expected to encourage more beneficiaries to obtain screening for the early detection of colorectal cancer. 

“Once again, we are moving to improve the quality of care provided to Medicare beneficiaries by making available emerging technologies that are demonstrated to be clinically useful, including this less intrusive procedure for colorectal cancer detection,” CMS Administrator Tom Scully said. 

Based on a technology assessment that CMS requested from the Agency for Healthcare Research and Quality (AHRQ), and after consultation with appropriate organizations as required by the Medicare law, CMS has decided to provide for annual coverage of the screening iFOBT as an alternative to (or substitute for) the screening guaiac fecal-occult blood test (gFOBT), for all beneficiaries age 50 and older.

The immunoassay test requires the collection of fewer specimens than the guiaic test and does not require any dietary restrictions.

“The immunoassay fecal-occult blood test appears to be both accurate and easy to use, but is not yet covered by most payers.  Medicare reimbursement for this test should lead to reduced morbidity and mortality for colorectal cancer,”  Sean Tunis, MD, CMS’ Chief Medical officer said.

Colorectal cancer (CRC) is the fourth most common cancer in men and women in the United States, and the second leading cause of cancer mortality.  Scientific studies have shown that early detection and treatment can have a major impact on mortality from CRC.  One type of screening for CRC detects occult blood in the stool.

Since 1998, Medicare has covered a gFOBT, which detects peroxidase activity in hemoglobin.   Recently, several screening iFOBTs have been developed, which use an antibody to detect hemoglobin in the stool, and which are aimed at precluding the need for certain dietary restrictions that some researchers believe need to be applied prior to and during the collection of the screening gFOBT samples to ensure the best results. 

Details of the decision memorandum announced today can be found at http://www.cms.gov/ncdr/trackingsheet.asp?id=87.