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Civil Monetary Penalty Clinical Laboratories

King & Spalding

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

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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

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

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

Bricker Graydon LLP

Clinical trials and Medicare billing: Avoiding false claims liability

Bricker Graydon LLP on

Participating in clinical trials can leave health care providers vulnerable to false claims liability if Medicare rules are not closely followed. This publication reviews settlements involving clinical trials, provides an...more

Foley & Lardner LLP

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

Foley & Lardner LLP on

As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more

Polsinelli

CMS Proposes Overhaul of Clinical Lab Payment Methodology: What You Need To Know

Polsinelli on

On Friday, the Centers for Medicare & Medicaid Services (“CMS”) issued a long-awaited proposed rule that would drastically change the payment rates for clinical laboratory services beginning January 1, 2017 (the “Proposed...more

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