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CLIA Civil Monetary Penalty

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

Bass, Berry & Sims PLC

Eleventh Circuit Becomes First Appeals Court to Hold that Excessive Fines Clause Applies in Declined FCA Cases

Bass, Berry & Sims PLC on

The Eleventh Circuit has become the first federal court of appeals to directly address whether the Eighth Amendment’s Excessive Fines Clause applies to the monetary award in a declined False Claims Act (FCA) case. And in an...more

K&L Gates LLP

K&L Gates Triage: CMS Cease and Desist Letters to COVID Labs and Reimbursement Dispute

K&L Gates LLP on

In this episode, Stephen Bittinger discusses the recent announcement that cease and desist letters from the Centers for Medicare & Medicaid Services (CMS) have been sent to 171 facilities testing for COVID-19 without proper...more

ArentFox Schiff

CMS Revises Survey Prioritization and Resumes Enforcement Activities

ArentFox Schiff on

On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Guidance Memorandum (Guidance) setting forth revised state survey agency priorities as well as providing information regarding the resumption...more

Mintz

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Mintz on

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

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