TAG:
Department of Health and Human Services
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…
Federal Court Reverses Conviction in AKS Case
CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…
UnitedHealth Group Heads into Difficult Waters Mid-Year
WITH THE NEWS THAT THE FORMER HEAD OF UNITEDHEALTH GROUP (UHG) has returned after the sudden resignation of the company’s CEO, it is apparent that pressure on the healthcare company continues to mount. This latest twist comes on top of a bad…
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…
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…
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…
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…
HHS Revises HIPAA Privacy, Security Rule
CEO SUMMARY: Officials at the Department of Health and Human Services (HHS) are proposing significant changes in what observers are calling a major revision to HIPAA’s requirements for protected health information (PHI) and cybersecurity. HHS issued a statement that the objective of the…
January 27, 2025, Intelligence: Late-Breaking Lab News
On Jan. 16, 2025, Paul Mango died at the age of 65. With his passing, the profession of laboratory medicine lost an ally and a friend. In the mid-1990s, while at the Institute for Transfusion Medicine in Pittsburgh, Mango convinced the CEOs of 40 hospitals to collaborate and create t…
Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome
On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final …
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Volume XXXII, No. 12 – August 25, 2025
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