Coding and Billing Guidelines

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:

• Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law
• 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 available literature and/or the literature supplied by the developer, and are not a part of a clinical trial
• Tests typically performed on patients younger than 65 years of age and outside of the Medicare population
  • Tests performed on patients receiving Medicare benefits younger than 65 years will be reviewed on a case-by-case basis

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.