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
Make sure your lab billing staff is aware of the changes to ensure full reimbursement.
Based on validation study data, the test offers 90 percent accuracy and is unaffected by the emergence of new COVID-19 variants.
Second quarter diagnostics earnings were down, but not as much as predicted.
The new guidelines offer patients advice on when they should start their screening, and how often they should have it done.
While the rule is not yet final, it’s likely that labs will have to pay more in direct CLIA compliance expenses, starting in October.
Users should realize that the FDA can extend the shelf life of a test when and if it receives additional data supporting such an extension.
For labs, the big takeaway is how prominently molecular testing and profiling figures in so many aspects of the NCCN’s recommendations.
Most healthcare-related enforcement actions from July and August involved urine drug tests and genetic testing.
The process is now slightly less rigged in insurers’ favor.
Ventura County’s organized health system and three medical care providers were accused of falsely billing Medi-Cal.