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A proposed rule from the Center for Medicare and Medicaid Services (CMS) could restrict coverage of genetic tests for patients with cancer, particularly those with late-stage disease. If the rule is finalized, CMS would cover only U.S. Food and Drug Administration (FDA)-approved next-generation sequencing tests. Many other widely used genetic tests would no longer be available to Medicare beneficiaries. The new rule would particularly affect patients with lung cancer, for which no FDA-approved blood-based sequencing tools exist.

“This proposed coverage policy is overly restrictive, and we are concerned that it could dramatically reduce patient access virtually overnight,” the American Medical Association (AMA) told CMS in a comment submitted on the draft rule. “…If not phased in with adequate lead time, [the provisions of the proposed national coverage determination] will disrupt current patient care plans and likely delay treatment – where treatment is time sensitive.”

Patient advocacy groups worry that access to tests already in use will be delayed as manufacturers pursue premarket FDA approval for their devices.