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
Expert Q&A: Trends and Challenges in Lab Billing and Coding
Ann Lambrix, vice president of RCM Solutions at Lighthouse Lab Services, discusses key developments in lab billing and coding.
February 2024 Labs in Court
Recent cases show labs should be wary of issues such as improper relationships, medical necessity, kickbacks, and potential telehealth fraud.
Billing and Coding: The Value of Clinical Validation
What clinical validation really means—and why every member of the laboratory should understand it.
Can Conducting a Billing Audit Increase My Lab’s Revenue Stream?
Audits can be helpful not just for compliance purposes, but for maximizing reimbursement and maintaining a healthy business.
FDA Watch: Key Lab Test Clearances of 2023
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
January 2024 Labs in Court
Recent cases involve Medicare’s 14-Day Rule, improper PHI disclosure to a media outlet, kickbacks, and COVID-19 fraud.
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
AI in Healthcare: What Do Recent Developments Mean for Labs?
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.
Patient-Centric Strategies for Labs: A Roadmap for 2024
Five strategies for lab leaders to focus on to tackle the challenges of today and ensure future success.
OSHA Citations for Hazardous Chemicals in Labs May Stem from Subpar Training
Standard 1910.1450 requires labs to have a chemical hygiene plan.
