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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
GAO: $77.3 Billion in Improper Medicare/Medicaid 2017 Payments, Including $1.82 Billion to Labs
From - National Intelligence Report
Medicare made $36.2 billion and Medicaid $41.2 billion in improper payments in fiscal year 2017. That's the finding of a report from…
Progress Seen With EGFR Testing, But Adoption Still Lagging
From - Diagnostic Testing & Emerging Technologies
Incomplete implementation of EGFR testing guidelines remains a problem in the realm of non-small cell lung cancer (NSCLC), according to a study published in…
Inside the Lab: Communication, Leadership & Managing Amid Change
From - Laboratory Industry Report
Greek philosopher Heraclitus said the only thing constant is change. Although he never managed a diagnostic lab…
FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
Health Reform: The Latest Twist in the Legal War on Obamacare
From - National Intelligence Report
The Affordable Care Act, aka Obamacare, remains alive but certainly not well. When last we left the melodrama, a federal district court in…
Can a Blood Test Quantify Pain?
From - Diagnostic Testing & Emerging Technologies
A new test could help clinicians objectively measure pain. According to a study published…
OIG Monthly Work Plan Review: March 2019
From - Lab Compliance Advisor
This month, there were 16 new Work Plan items. Three of these may have implications for some labs as…