As regulatory changes and technical advances reshape the clinical lab, directors are seeing a shift in responsibilities and the expertise required for the job.
The ruling overturned a lower court decision that blocked ACLA's suit challenging the data collection process used by CMS to set test prices under PAMA.
The company decided to settle the complaint in order to avoid "lengthy and distracting litigation," but denies any wrongdoing.
The collaboration between 15 federal and state groups used a workshop format originally developed by CDC to help other countries with their One Health issues.
The American Academy of Family Physicians said that the changes being considered by CMS would increase the financial burden on laboratories.
Industry organizations like ACLA are seeking changes to the bill, which appears to outlaw standard business practices such as paying sales staff on commission.
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.