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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.
Members of the FDA, CDC, and CMS, comprising the Tri-Agency Task Force for Emergency Diagnostics, will work together to quickly respond to public health needs.
Lab director Glenn George discusses trends within clinical microbiology that could set it apart from other portions of the clinical laboratory.
DOJ alleges that Arriva offered free upgrades of medically unnecessary glucometers to Medicare beneficiaries, and then billed Medicare for the equipment.
The agency said its aim is to analyze the way CMS has chosen to implement PAMA and to estimate the potential financial impact to Medicare as a result of those choices.
Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.
The non-coverage decision came despite appeals by the company following a draft non-coverage determination issued last year.