TAG:
Congress
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…
Lab Stakeholders Discuss PAMA Reform
CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …
How Medicaid Cuts May Affect Clinical Labs
CEO Summary: As lawmakers debate the merits of President Donald Trump’s budget bill, it appears that Medicaid changes are on the horizon. For medical laboratories, three immediate areas to monitor include potentially decreased Medicaid recipients, federal cuts to Medicai…
Don’t Pass Up Chance to Steer LDTs, PAMA Reform
CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CH…
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
Enjoy the LDT Court Victory, Yet Remain Vigilant
VICTORY IN COURT! FOR AN INDU…
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
OIG Issues New Report on Medicare 2023 Lab Spend
CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
Once Again, Congress Acts to Defer Medicare Lab Fee Cuts
LAST MONTH, CONGRESS ONCE AGAIN DEFERRED MEDICARE REIMBURSEMENT CUTS OF UP TO 15% f…
CURRENT ISSUE
Volume XXXII, Number 16 – November 17, 2025
The Dark Report offers insights into innovative ways to engage employees, streamline workflows, and build talent pipelines. Standard Health Care’s Jennifer Fralick outlines strategies to retain talent and improve efficiency. Also, The Dark Report provides a review of NYU Langone Health’s Digital Pathology Implementation, and the Pathology director explains why smaller labs should consider DP.
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