FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Pre-submission and Q-Submission meetings apparently have been halted, for now
According to a recent OIG report, CMS is not doing a good job collecting the Medicare overpayments OIG auditors are uncovering. However, CMS recently rejected almost all of the recommendations in that report, suggesting all is not well between the two federal agencies.
In addition to increasing and imposing new user fees, the proposed rule would allow nurses to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here's what lab managers need to know about the proposed rule.
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
In July, ICATT took a major step toward equitable access to testing by enlisting two of the country’s leading COVID-19 PCR test providers.
It’s beginning to look like Illumina’s roll of the dice is going to come up snake eyes regarding the potential acquisition.
The way the No Surprises Act is implemented would essentially allow private health plans to set out-of-network rates in billing disputes.
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
In this month’s Labs in Court roundup, BioReference pays big to settle kickback allegations, among several other kickback-related cases.
With the final rule on PT published July 11, here are the five things lab managers need to know to keep their labs compliant.
D.C. Circuit Court of Appeals agrees with lab industry that CMS got Medicare lab pricing all wrong, but says it’s unable to intervene.