How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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Articles and Reports
FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Billing and Coding: The Secrets of Effective Queries
Formulating queries that are compliant, informative, and effective—even in tricky situations.
AI Pilot Program Proposed to Detect Medicare Fraud
Program outlined in a recently introduced bill would test AI’s effectiveness in detecting suspect payments for diagnostic tests and DME.
Championing Change
How clinical laboratory professionals can advocate for legislative and regulatory improvements
Expert Q&A: What’s New with PAMA and SALSA?
Joyce Gresko, partner at Alston & Bird, discusses the latest on PAMA and what will likely need to happen for SALSA to pass in 2024.
Staying on Top of Medical Necessity and Marketer Compliance
Recent enforcement actions show that clinical laboratories must remain vigilant about compliance relating to these areas
FDA Watch: New Test for Esophageal Conditions is Coming to the US
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
Dx Deals: Quest and Labcorp Move beyond Laboratory Testing
Both companies have made recent moves to diversify further.
Boosting Retention and Hiring in Medical Laboratories
Key reasons for continued staffing shortages and tips for addressing these issues to support current staff and attract new talent.
We’ve Lost Our Lab Director, Now What?
Key steps to successfully navigate a CLIA laboratory director transition and select the best possible replacement for your organization.
Tool: Guide for Assessing Lab Director Candidates
Key areas to address when reviewing CLIA lab director applicants and developing interview questions.
