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CMS to Cover FDA-Approved, -Cleared NGS Germline Tests for Breast, Ovarian Cancer Patients

NEW YORK – The Centers for Medicare & Medicaid Services on Monday finalized the criteria under which it will grant national coverage to next-generation sequencing tests for assessing inherited cancer risk.

Under a final national coverage decision, the payor has agreed to grant national coverage only to NGS tests with the US Food and Drug Administration's approval or clearance for patients with breast or ovarian cancer, when test reports specify treatment options. Tests will be covered nationally specifically for breast and ovarian cancer patients who have a clinical indication for germline testing for hereditary breast or ovarian cancer syndrome and a risk factor for the inherited forms of these cancers. Patients cannot previously have been tested using the same germline test for the same genes.  

CMS is also allowing its Medicare Administrative Contractors to determine local coverage for NGS tests that aren't FDA approved or cleared, but are performed in a CLIA-certified lab, when tests are ordered by a doctor, and when results inform management decisions. Local coverage will be provided to tests when performed for patients with any cancer diagnosis when they have a clinical indication and risk factor for germline testing for inherited cancer. Patients cannot have previously received the same germline test for the same genes.

This NCD comes more than a year after stakeholders widely objected to CMS instructing its MACs to restrict coverage for germline NGS panels when performed in individuals with early-stage cancer. Stakeholders ultimately convinced CMS to address the confusion around its coverage policy for germline NGS testing by reopening its earlier issued NCD, entitled "Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer."

When it issued the draft coverage proposal in October last year, CMS lifted the restrictions around early-stage cancer, but put forth new requirements related to FDA approval and clearance. However, as industry observers have pointed out, no FDA-approved or -cleared NGS test on the market currently meets all the terms for national coverage for germline analysis. However, in the final NCD, CMS appears to have stuck with its criteria to require FDA premarket review for germline NGS tests for breast and ovarian cancer patients for national coverage, but now is also giving MACs the ability to determine local coverage for all hereditary cancer NGS tests.

In the draft version, CMS also said it would only cover germline NGS testing for patients who had not previously been tested with any NGS test. The government payor appears to have reined in that restriction in the final NCD and now covers germline NGS testing as long as the same germline NGS test hasn't been performed on a patient for detecting the same genes.