Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.
Pricing for FoundationOne CDx, which received FDA approval and a proposed CMS national coverage determination yesterday, will be determined under PAMA.
The FDA approved FoundationOne CDx and the Centers for Medicare and Medicaid Services concurrently issued a proposed national coverage decision for the test.
After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.
The new agreement brings Interpace's total insurance coverage for its thyroid assays to approximately 200 million patients.
While undergoing parallel review for its FoundationOne test by the FDA and CMS, the firm will continue to work with its local MACs on reimbursement.
The company hopes to simultaneously achieve premarket FDA approval and a national coverage determination from CMS for its NGS cancer panel.
The firm has billed commercial insurers for more than 17,000 tests and reported test results for more than 15,000 Medicare patients without receiving payment.
OKP will pay for testing if standard first trimester screening indicates a risk higher than 1:1000 for trisomies 21, 18, or 13.
New results from the NASA Twins Study indicate that the immune system may rev up when in space, the Washington Post reports.
Kelvin Droegemeier, the new science advisor, spoke at the American Association for the Advancement of Science meeting, Geekwire reports.
In PNAS this week: whole-genome assembly for the white shark, paper-based microfluidic method for detecting the malaria parasite, and more.
The World Health Organization has announced the members of its gene-editing committee, according to NPR.