Last November, the FDA approved the largest one of these genetic sequencing tests to date R12; a product called F1CDx that can detect genetic mutations in 324 genes. With information about the specific mutations in a patient’s tumor cell DNA, physicians can then select treatment plans that better fit that individual patient. Or if a relevant treatment option isn’t available, physicians can use the information to determine if patients may be suited for certain clinical trials.
CMS will cover any such tests approved by the FDA and newly approved tests will be automatically covered. There are other similar tests used by doctors that haven’t yet been approved by the FDA and in those cases, local Medicare Administrative Contractors will determine whether Medicare will cover the cost on a case-by-case basis.