ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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Articles and Reports
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
DX Deals: Large Healthcare Bankruptcies Rebound from Pandemic Lull
A recent report offers new insight into bankruptcy trends within the sector starting before the COVID-19 pandemic.
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.
OIG Roundup
In this OIG roundup, we cover the agency’s plans to modernize and improve the useability of its Compliance Program Guidance, which was first published in 1998.
Proposed FTC Ban on Noncompete Agreements Could Be Highly Disruptive to Lab Staffing
A proposed move to make noncompete agreements illegal could impact retention of some laboratory employees.
Brief Your Billing & Coding Staff on New Medicare HCPCS & CLIA Code Changes
To avoid claims denials and improper billings, ensure billing and coding staff is aware of, and has adjusted to, all recent coding changes.
