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Printed Date: 9/22/2015
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 IOM 100-2, Ch. 15, Sec 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.
Does the test fall within a Medicare benefit category?
Based on the Medicare Benefit requirements, the following test types are examples of services that may not be considered a benefit (statutory excluded) and therefore would be denied as Medicare Excluded tests:
MolDX reviews test registration applications and technical assessments (TA) to confirm that each test meets Medicare reasonable and necessary criteria. Covered tests reviewed through the TA process are identified in the Molecular Diagnostic Test policy found in the LCD section. Coding and Billing guidelines are available to facilitate reimbursement.
MolDX Coding and Billing Guidelines for excluded and covered tests can be viewed by accessing the Medicare Coverage Database.
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Last Updated: 3/01/2021
Applies to: MolDx
Article Topics: Appeals, Redeterminations, and PTANs