New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
New Short-read Transpore Rapid Karyotyping test can identify fetal chromosomal abnormalities in a variety of samples.
Technology can make it possible for labs and other healthcare providers to boost revenue while still providing a positive patient experience.
Federal enforcers and whistleblowers home in on billing of medically unnecessary sleep tests.
A recent study shows that the proportion of undiagnosed diabetes has dropped over the past three decades, but certain groups are more affected.
A new rule proposed by the agency would also mean new fees for follow-up and complaint surveys.
In key enforcement actions announced over the last week, a Texas-based owner faces 60 months behind bars for defrauding Medicare.
The agency is recommending repeat testing with at home COVID-19 antigen tests, regardless of actual symptoms.
The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
OIG says the agency is leaving millions of dollars on the table, but CMS doesn’t want to hear it.
Individuals were supposedly paid kickbacks to obtain genetic samples for unnecessary genetic testing, which was then falsely billed to federal healthcare programs.