Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
Laboratory Initiation of Cascade Genetic Testing Spurs Uptake
From - Diagnostic Testing & Emerging Technologies
A laboratory-initiated, online effort to reach cancer patients' relatives coupled with discounted genetic tests can increase rates of cascade testing, according to…
Case of the Month: Facing 3 against 1, Texas Lab Settles EHR Consulting Kickback Charges
From - Lab Compliance Advisor
Question: What happens when multiple whistleblowers bring separate qui tam lawsuits against a lab for the same offense…
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
From - Laboratory Industry Report
The past few weeks have brought snow to parts of the country that don't usually see the white stuff, and a flurry of…
How to Determine Date of Service for Part B Billing of Outpatient Lab Tests
From - Lab Compliance Advisor
Date of service rules affect whether outpatient lab tests are part of the Hospital Outpatient Prospective Payment System (HOPPS) bundled payment or…
Exome Sequencing Improves Diagnosis of Fetal Structural Anomalies
From - Diagnostic Testing & Emerging Technologies
Prenatal diagnostics have evolved from conventional cytogenetic analysis to increasingly chromosomal microarray analysis, within the last…
HHS Proposes Eliminating Drug Rebates to Cut Medicare Prescription Costs
From - National Intelligence Report
On Jan. 31, Department of Health and Human Services Secretary Alex Azar floated a proposed rule to…
Communication: Managing Amid Change
From - Laboratory Industry Report
Greek philosopher Heraclitus said the only thing constant is change. Although he never managed a diagnostic laboratory, his words…
FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From - National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…