TAG:
lab risk & compliance
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…
JAMA Authors Warn LDT Legal Defeat Brings Risk for Labs
CLINICAL LABORATORY AND ANATOMIC PATHOLOGY LEADERS WILL WANT TO NOTE will a recent JAMA Health Forum article that strikes a cautionary tone about the future of laboratory developed test (LDT) regulation. The piece argued that the recent federal court decision…
Using Sophisticated Schemes, Fraudsters Hit the Next Level
Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history. Cli…
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…
Labs Beware: ‘Vishing’ Rises as Major Cybersecurity Threat
CYBERSECURITY SHOULD ALWAYS BE TOP OF MIND FOR CLINICAL LABORATORIES AND PATHLOGY groups, especially since the notorious data breach at Change Healthcare in February 2024. Often, such security breaches begin with phishing campaigns in which employees are enticed to click on malicious li…
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…
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
Trump Signs Executive Order on Price Transparency
ON FEBRUARY 25, PRESIDENT DONALD TRUMP SIGNED AN EXECUTIVE ORDER targeted at driving price transparency requirements for hospitals and insurers. The order aims to strictly enforce a previous rule, signed during his first term, intended to provide patients with cl…
Some Health Plans Drop Deductibles as Response to New Consumerism
It may surprise many pathologists and clinical laboratory administrators to learn that one major health insurer’s best-selling plan has only copays and no deductible, no coinsurance, and no cost-shifting! That plan is Surest, a group plan offered by UnitedHealthcare in recent ye…
Proposed Clinical Laboratory Price Transparency Bill
IN DECEMBER, THE CLINICAL LABORATORY PRICE TRANSPARENCY ACT OF 2023 was referred to the U.S. House Ways and Means Subcommittee on Health for final approval. The bill requires labs to disclose information regarding pricing before administering services. The goal is to ensure patients better understand…
CURRENT ISSUE
Volume XXXIII, No. 4 – March 23, 2026
A federal court ruling has established a safe harbor for clinical labs when they run tests ordered by physicians. Lab leaders should examine this briefing for pitfalls. Also, it turns out that providers may be ordering inappropriate vitamin D tests, according to one expert.
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