HHS

Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.

The RT-qPCR-based assay, which has 510(k) clearance, is designed to rapidly differentiate sepsis from systemic inflammatory response syndrome.

The amicus briefs challenge the method in which HHS collected data to establish market-based Medicare prices and found flaws in a district court decision dismissing the case.

HHS Secretary Azar's implementation of PAMA resulted in market-based Medicare prices that don't accurately represent the market, ACLA argues.

ACLA was critical of the report, saying it "fails to reflect market reality" and calling on Congress to intervene to prevent further cuts.

The award comes after DNAe completed the first phase of a contract valued at up to $51.9 million, which BARDA initiated in September 2016.

The association is concerned that waived testing sites are operating with insufficient oversight and compromising patient safety, and is asking Congress to investigate.

The contract supports the development of a benchtop, fully automated platform and rapid tests to detect urinary tract infections and anthrax poisoning.

The company will receive an upfront $9.3 million to fund a clinical trial for its NGP phenotyping platform and is eligible for an additional $36 million.