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
How to Ensure Proper Documentation for Billing Laboratory Services
What do lab professionals need to do to ensure sufficient documentation for billing clinical laboratory and pathology services?
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
September 2023 Labs in Court
In last month’s key cases, Illumina and Guardant seek to dismiss lawsuit related to trade secrets and breach of contract.
Brief Your CEO: New SCOTUS Case May Help Your Lab Defend Meritless Whistleblower Cases
A recent SCOTUS ruling on a healthcare fraud case could help defend labs against baseless whistleblower cases.
Billing & Coding: The Expanding Role of Z-Codes
Labs will have to submit Z-Codes with every molecular pathology testing code billed to UnitedHealthcare, starting Aug. 1.
August 2023 Labs in Court
Last month’s key cases involved the outcome of a UHC lawsuit and fines for misleading claims about a COVID-19 test.
Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
Billing & Coding of Infectious Disease Testing
Recent developments pose reimbursement and compliance challenges for billing and coding infectious disease testing—here’s how to manage them.
July 2023 Enforcement Roundup
Though UDT-related enforcement actions predominate, an uncommon vendor-related case was in the mix this month.
July 2023 Labs in Court
Recent cases involve COVID-19 fraud, UDTs, and the latest HIPAA Right of Access settlement.
