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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Routine Mass Spectrometry in Clinical Labs: A Competitive Advantage?
How a new automated system bringing MS to routine lab testing could help set laboratories apart from their competitors
Medicare Expands Coverage of Molecular Cancer Screening Tests
In terms of Medicare coverage, 2023 is shaping up to be a fruitful year—here are five of the most significant approvals so far.
Growth of Medical & Consumer Debt Poses New Challenges for Collections
Increasing medical and consumer debt is likely to get worse, meaning billing and collections may get even tougher for labs.
Hostile Regulatory Environment Further Chills Diagnostics Market
The biggest story in M&A dealmaking continues to be the deal that’s being undone—Illumina’s acquisition of GRAIL.
A Timeline of 2023 Lab Company Layoffs So Far
The wave of layoffs, which began last year with the declines in COVID-19 testing sales, has gathered momentum in 2023.
Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
Lab Companies Team with Nonprofits on Test Development, Access, & Awareness
April was among the busiest months, in recent memory, in terms of both deal volume and significance in the diagnostics industry.
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.
Urine Drug & Genetic Testing Remain Top Enforcement Targets
In an analysis of enforcement actions from the end of 2022 to early spring 2023, cases involving urine drug testing were the most prevalent.
How to Perform a Billing, Coding, & Reimbursement Process Compliance Audit
Auditing in medical laboratories is critical for reviewing processes to identify erroneous outcomes, as well as areas for improvement.
