TAG:
laboratories
“New” Legal Landmines For Clinical Laboratories
CEO SUMMARY: HIPAA is a big “new” source of legal expo- sure for laboratories and other healthcare providers. Also, recent court decisions and changes in clinical practices are adding to the legal risk for labs. Attorney Richard S. Cooper offers insights on how laboratories can better…
Abbott Acquires I-Stat, Resolves FDA Problems
CEO SUMMARY: On December 15, Abbott revealed that it would pay $392 million to acquire I-Stat. Days later, on December 18, Abbott disclosed that the FDA had deemed its Lake County, Illinois diagnostic manufacturing plant to be “in substantial conformity” with the Quality System Regula…
Who’s Buying Labs? Activity Shifts Down
CEO SUMMARY: As the number of independent clinical laboratories dwindles, most remaining owners seem content to continue building their business—at least until a buyer makes them an offer “they can’t refuse.” Acquisitions of pathology group practices were also few in number during…
ABNs, Client Billing, “Free Testing? & Medicare Rules
BY ANY MEASURE, ENFORCEMENT ACTIONS by the Office of the Investigator General (OIG) for Medicare fraud and abuse within the laboratory testing industry was a big story during the 1990s. I wonder if we might not be at a crossroads that could take our profession down a similar path in …
“Free Testing” Strategy Stirs the Pot in Tenn.
CEO SUMMARY: In Tennessee, the state’s Medicaid HMO plan has been at odds with Quest Diagnostics Incorporated, which is using the “free testing” strategy to expand its share of the market. In recent months, TennCare Select has taken active steps to insure its physicians understand tha…
“Waiver of Charges”: What Makes It Work
CEO SUMMARY: Little-used in the 1990s, when laboratory test ordering and billing practices were under intense scrutiny by federal regulators, the strategy of “free testing” is popping up in more regions around the country. To comply with compliance guidelines, labs using this strategy g…
Lab Marketing Strategy Triggers Legal Concerns
CEO SUMMARY: That famous phrase “everyone wants something for nothing” does not describe TennCare Select’s reaction to the “free testing” that Quest Diagnostics is performing for its beneficiaries. TennCare provides a real-world example of how this strategy can put a laboratory at o…
Where Will “Free Tests” Take the Lab Industry?
CEO SUMMARY: In the absence of public discussion, continued use of the “free testing” strategy by the nation’s more aggressive laboratory companies could trigger some unpleasant consequences that would affect all laboratories and pathology group practices. Five questions, presented he…
Supply and Demand for Lab Services and Pathologists
IT SEEMS THE LABORATORY INDUSTRY HAS MANAGED to beat back the proposed 20% patient co-payment for Medicare Part B laboratory testing services. Kudos to the hard-working laboratorians and their lobbyists who devoted money and time to oppose this proposal. But the news remains glum. Word is that lawma…
HPV Test Volume Grows With Payer Acceptance
CEO SUMMARY: Because cervical cancer screening involves more than 55 million Pap tests per year in the United States, it is a high-profile segment of the lab testing industry. HPV testing is making steady inroads into the cervical cancer screening process. Digene Corporation is the direct…
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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