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CEO Offers Lab Strategies for a Post-PAMA World
CEO SUMMARY: With so many market forces working against the economic interests of clinical laboratories, it is essential that all labs develop appropriate strategies designed to sustain the quality of laboratory testing services and the financial integrity of the laboratory organization. …
Court Dismisses ACLA Claims in PAMA Case
CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims f…
Anthem Alleges $16M in Calif. Hospital Lab Fraud
CEO SUMMARY: In a lawsuit filed in the U.S. District Court for the Central District of California, Anthem and affiliated Blue Cross Blue Shield plans alleged that 37-bed Sonoma West Medical Center, a Florida lab testing company, a medical billing company, and others used a pass-through la…
ProMedica, Sonic Form Lab Outreach Joint Venture
CEO SUMMARY: Fast-growing ProMedica Health System of Toledo, Ohio, agreed to a laboratory joint venture with Sonic Healthcare USA. As lab budgets and prices for lab tests are squeezed downward, ProMedica sees opportunity to add volume to this new core lab facility to improve efficiency an…
Do Hospitals Want to Sell or Outsource Their Labs?
This is an excerpt from a 883-word article in the August 20, 2018 issue of THE DARK REPORT. The complete article and two related articles are available to all readers, with a three-article cap. CEO SUMMARY: Common wisdom on Wall Street is that many hospi…
Pap Test Errors in Ireland Attributed to Quest, CPL
CEO SUMMARY: In Ireland, the big story in healthcare at the moment is the discovery that the nation’s cervical cancer screening program has failed hundreds of women who had pre-cancerous conditions or cervical cancer, but, as alleged in numerous court cases, their tests were inaccurate …
Dartmouth-Hitchcock Builds Strong Lab Outreach Business
CEO SUMMARY: As health networks and hospitals consider outsourcing their lab outreach programs, the lab team at Dartmouth-Hitchcock Medical Center (D-H) offers lessons about the value of retaining outreach. D-H is now in the eighth year of a sustained expansion of its laboratory outreach …
Legal Briefs Explain Problems with PAMA Implementation
CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own reque…
Response to FDA’s Gottlieb on Reducing Regulatory Burden
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He …
NC Hospital Reviewing Path Lab Deficiencies
CEO SUMMARY: Discovery of multiple diagnostic errors occurring in an anatomic pathology department triggered a complaint investigation and a 54-page report from the federal Centers for Medicare and Medicaid Services. The report shows that Wake Forest Baptist Medical Center is reviewing mo…
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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