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
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.
Comprehensive Coding
Understanding the 2024 CLFS update—and the changes that are still to come.
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.
Expert Q&A: Lab and Pathology Industry 2023 Year in Review
ASCP chief medical officer Ali Brown, MD, FASCP, discusses the highlights of 2023 and ASCP’s plans for supporting its members in 2024.
Dx Deal Roundup: Top 10 Clinical Lab M&A Deals of 2023
An overview of the key 2023 mergers and acquisitions in the diagnostics industry and the trends they reveal.
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.
A Modern Healthcare Collaboration
Labs, patients, and technology must all work together to deliver forward-thinking patient-centered care.
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.
Expert Q&A: 2023 Lab Industry Highs and Lows, and 2024 Outlook
Robin Divine, MBA, president and CEO of TriCore Reference Laboratories, discusses key recent developments in the lab industry and predictions for 2024.
