CMS

The company's cofounders will pay $500,000 each to settle allegations by the US Department of Justice that they submitted false claims to Medicare.

The agency wants to waive the "substantial clinical improvement" criteria for medical devices for two years and increase the add-on payment.

The American Academy of Family Physicians said that the changes being considered by CMS would increase the financial burden on laboratories.

CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.

At issue are updates to CMS' guidance instructing labs to report single HCPCS/CPT codes even in cases where a procedure produces multiple reportable results.

The agency said it is sensitive to stakeholder concerns and is working with MACs to adjust claims processing systems.

The ctDNA test will be covered for all US fee-for-service Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.

The organization has been approved to accredit labs in the areas of microbiology, diagnostic immunology, chemistry, hematology and immunohematology.

The company's revenues in the quarter rose to $221.9 million from $161.0 million in Q4 2017, but it missed the consensus Wall Street estimate of $245.3 million.