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
Compliance Perspectives: The Risks of Using ChatGPT & How to Manage Them
While ChatGPT has its place, allowing lab staff to use it exposes you to liabilities—here are some ways to manage the risks involved.
Compliance Tool: Model ChatGPT Acceptable Use Policy
As generative AI chatbot use increases, labs may want to implement a written acceptable use policy for staff.
Compliance Tool: Model Mandatory Excluded Provider Screening Policy
A written policy helps establish your right to do excluded persons checks and take appropriate actions if they come back positive.
Labs in Court
In recent key cases, the national drug retailer must stand trial for failing to protect customers from faulty Theranos products.
Billing & Coding: What to Know About New Category III CPT Codes for Digital Pathology
The new codes have garnered attention as a future mechanism for additional reimbursement and thus deserve further discussion.
Compliance Perspectives: How to Perform Excluded Provider Checks
Hiring, retaining, or simply doing business with the wrong people may expose your lab to significant financial penalties.
Kentucky $1.74 Million Settlement Illustrates the Danger of Billing Medicare for Nonmedical Urine Drug Tests
A recent False Claims Act settlement from Kentucky represents an unusual variation on a common theme.
4 Things to Know About the End of the COVID-19 PHE
The end of the COVID-19 public health emergency on May 11 also brings certain flexibilities for labs and other providers to an end.
Quiz: Is This Illegal Remuneration Under the AKS?
A recent court case sheds some light on if denying employment can count as illegal remuneration under the Anti-Kickback Statute.
Labs in Court: Lab Settles Kickback Allegations for $5.9M
Two companies settle kickback and FCA-related claims, a qui tam case is tossed, and a lab tech loses a workplace harassment case.
