The recent OIG report on the implementation of PAMA doesn’t address that CMS has ignored congressional intent in implementing the law, ACLA said.
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.
CMS will reimburse FoundationOne CDx at a rate of $3,500 per test for a nine-month period starting July 1.
The company said it has produced documents in response to the government's civil investigative demand notice.
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 company has developed a suite of tests designed to measure immunoglobulin E and immunoglobulin G levels for allergy and dietary wellness testing.
LabCorp also plans to introduce an in-home testing device sometime this quarter, company officials said.
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.
Both sides have filed competing arguments requesting the judge rule on the case without a trial.