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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
New Guidelines Released for Pancreatic Cancer Screening
The American Society for Gastrointestinal Endoscopy releases new recommendations for screening those with genetic susceptibility.
Caris Life Sciences Settles Medicare 14-Day Rule Claims for $2.88 Million
The company was facing allegations that it had intentionally delayed submitting lab tests in order to circumvent the rule and receive payment.
Alleged Violation of Medicare’s 14-Day Rule Costs Company $2.8 Million
Caris Life Sciences agrees to pay $2.8 million to settle claims that it purposely delayed submitting lab tests to get around Medicare’s 14-day rule.
CMS Reschedules PAMA Reporting & Adds New PLA Codes
Here are the two key CLFS changes, set to take effect on July 1, 2022, that your billing staff needs to know about.
What the Federal COVID-19 Fraud Crackdown Means for Labs
If your lab received federal relief funds from the US government during the COVID-19 pandemic, you could be at risk of FCA lawsuits.
Revised VALID Act Proposes Risk-Based FDA Regulation of LDTs
The most recent congressional effort to pass LDT legislation may prove to be the one that finally comes to fruition.
Beckman Coulter Tabs IDT to Distribute Its Biomek NGeniuS NGS System
IDT will distribute the automated Biomek NGeniuS instrument in the US, Canada, UK, Sweden, Germany, France, Austria, and the Netherlands.
New Partnership Aims to Improve Genomic Variant Interpretation
Agilent and Genomenon team up to bring users more effective software and search tools for making a genetic diagnosis.
BioMérieux Closes $416.8 Million Acquisition of Specific Diagnostics
Bringing the Specific Reveal Rapid AST system into the fold enhances French firm’s global position in clinical microbiology.
Delay in Submitting Genetic Tests Costs Life Sci Company $2.8 Million
In this Labs in Court Weekly Roundup, all the main health care-related cases involved False Claims Act allegations or charges.