The coverage decision limits the test mainly to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue testing.
The list of regulated analytes needs to be reviewed and updated so that external quality controls are in place to protect patients, proficiency testing providers said.
Opko has until July 5 to comment on the proposed non-coverage local coverage determination, the most recent development in the test's twisted Medicare narrative.
The lawsuits were filed after the HHS OIG subpoenaed the firm as part of an investigation into how it billed Medicare and Medicaid for the myRisk test.
