TAG:
lab risk & compliance
Clinical Labs Must Prep for Heightened Audits
CEO SUMMARY: A new report from the Office of Inspector General sheds interesting light on just how much genetic testing has increased among Medicare Part B beneficiaries. With billions of dollars in reimbursement at stake for clinical laboratories, expect federal officials…
PAMA Cuts Averted Until ‘27; Labs Plan Next Move
CEO SUMMARY: Clinical laboratories have again avoided a potential financial disaster, at least for now, after Congress shifted PAMA cuts to test reimbursement rates until January 2027. However, the victory is temporary absent permanent PAMA reform. To that end, laboratory …
Translating Genomic Testing to the Clinic
CEO SUMMARY: An entrepreneur in the liquid biopsy sector outlines a series of questions to answer if a diagnostic innovation is to ever succeed in the commercial marketplace. Scientists and businesspeople will want to ask about a potential product’s significance, uniquen…
One Lab’s Solution to Its Histotechnologist Shortage
Histology workforce shortages remain one of the major challenges within the clinical laboratory industry, and, unfortunately, as the demand for histotechnologists increases, the number of qualified personnel has been decreasing. A report releas…
Labs Enter a Critical PAMA Reform Window
CEO SUMMARY: A reprieve of upcoming PAMA cuts to lab test reimbursement rates is official with an extension through Jan. 30, 2026. This, however, is not a lot of time and pressure is on the clinical laboratory industry to get the RESULTS Act passed to permanently reform PA…
Congress is Listening. Labs Must Step Up on PAMA
Just as The Dark Report went to press for this issue, the US federal government reopened after the longest shutdown in the country’s history. And while political pundits on both sides of the spectrum argued about who won and lost during the shutdown, it was clear that the cli…
Accreditors Explain Changes to CLIA Supervisor Qualifications
In December 2023, the Centers for Medicare and Medicaid Services (CMS) announced major updates to the Clinical Laboratory Improvement Amendments (CLIA) personnel regulations, which went into effect on December 28, 2024. During a panel discussio…
Could AI Oversight in Labs Fall Under a CLIA Model?
CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…
Court: Percentage-Based Comp Is Not Illegal in Itself
OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in…
How Federal Court’s Decision Will Affect Lab Marketing
MOST MEDICAL PROVIDERS are buyers of healthcare services. But for clinical laboratories, that equation is turned on its head. Labs are medical providers, but since they rarely provide those services directly to patients, they must properly market them to providers to ensure steady sales…
CURRENT ISSUE
Volume XXXIII, No. 3 – March 2, 2026
The Dark Report highlights the six themes that will carry the 2026 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management,, including finance issues and AI. Also, we show how RCM automation helped one lab conquer billing headaches and increase revenue.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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