October 20, 2015 - Revised: 09.27.18
Excluded Tests (CM00105, V3)
Medicare is a defined benefit program. In order to be considered for Medicare coverage, an item or service must fall within a statutory benefit category. Although the Centers for Medicare & Medicaid Services (CMS) Internet-Only Manual (IOM) Medicare Benefit Policy Manual 100-02, Chapter 15, Section 10
identifies "Diagnostic X-Ray tests, laboratory tests, and other diagnostic tests;" as a benefit category; Sec. 1862 (1)(A) Statutory Exclusion, "except for items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member," must also be applied. In order to be paid under this benefit category, a diagnostic test must be ordered by a physician who is treating the beneficiary and the results used in the management of a beneficiary's specific medical problem. Although many molecular diagnostic tests may provide valid and useful information, they do not meet this definition.
Based on the Medicare Benefit requirements, the following test types are not considered a benefit (statutory excluded) and, therefore, will be denied as Medicare Excluded tests:
- Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law
- Tests that do not provide the clinician with actionable data (information that will improve patient outcomes and/or change physician care and treatment of the patient)
- Tests that confirm a diagnosis or known information
- Tests to determine risk for developing a disease or condition
- Tests performed to measure the quality of a process
- Tests without diagnosis specific indications
- Tests identified as investigational by all available literature and/or the literature supplied by the developer and is not a part of a clinical trial
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