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The Centers for Medicare and Medicaid Services (CMS) recently finalized a new National Coverage Determination (NCD) to provide Medicare beneficiaries with coverage of FDA-approved or -cleared tests that help identify cancer treatment options. These tests, also known as companion diagnostics, examine a person’s tumor or blood to see which targeted medications may be most effective for treating their cancer.
Most Medicare beneficiaries are 65 years of age and older, but people under age 65 who are receiving certain disability benefits are also eligible. Note that this NCD only applies to Medicare; it does not pertain to Medicaid recipients. State Medicaid programs independently determine access to diagnostic tests.
The new policy provides patients with advanced cancer (defined as “recurrent, relapsed, refractory, metastatic, and advanced stage III or IV cancer”) with coverage for FDA-approved or -cleared Next Generation Sequencing (NGS) diagnostic panels.[i]
CMS initiated this new rule late last year after the Food and Drug Administration (FDA) approved the FoundationOne companion diagnostic test for solid cancer tumors. This test helps physicians identify:
Currently, four FDA-approved companion diagnostic tumor tests for advanced cancer patients fall under this NCD:
These, and any future diagnostic tests meeting the criteria outlined by CMS, are covered under the NCD. The policy is not limited to coverage of tissue-based cancer panels. Liquid biopsy tests that have FDA-approved or -cleared companion diagnostic indications will also be eligible for coverage.
Another companion diagnostic blood test—Myriad’s BRACAnalysis CDx, which is used to determine if women with advanced, recurrent ovarian cancer would benefit from Lynparza—is covered under a prior NCD.[ii] While NGS tests such as Oncotpye DX, Mammaprint, and Polaris can help guide treatment options, they currently do not have companion diagnostic indications and fall under different Medicare NCDs.
NCDs such as this aim to provide uniform coverage of treatments and/or health care services for Medicare beneficiaries. Experts agree that the new policy will not significantly affect access to NGS cancer panels because labs with tests that do not have FDA approval can still seek coverage with a Local Coverage Determination (LCD) via regional Medicare Area Contractors (MACs).
For more information on whether you may benefit from one of these or other companion diagnostic tests we encourage you to speak with your oncologist or check with your health insurer. The Patient Advocate Foundation is also an excellent resource for information on coverage of services and assistance programs.
[i] Next Generation Sequencing (NGS) tests covered in this policy are not the same as genetic testing for inherited cancer mutations such as BRCA1/2, ATM, or PALB2. FoundationOne and similar NGS test panels look for acquired mutations in cancer tumors to help guide treatment.
[ii] BRACAnalysis CDx uses different technology that doesn’t fall under the category of Next Generation Sequencing (NGS). As such, it is covered under a separate NCD which guide its use and coverage under Medicare.