News & Analysis as of

Clinical Laboratory Testing Centers for Medicare & Medicaid Services (CMS) CLIA

Bass, Berry & Sims PLC

Recent Updates to CLIA Proficiency Testing and Proposed Changes to Fees, Sanctions, and Other Requirements

Bass, Berry & Sims PLC on

This client alert highlights recent regulatory developments from the Centers for Medicare & Medicaid Services (CMS) relevant to clinical laboratories. CMS is implementing or considering implementing several updates to the...more

Arnall Golden Gregory LLP

Is There a Constitutional Limit to Excessive Fines in False Claims Act Cases? Eleventh Circuit Says a Million Dollar Fine for a...

In late December, the U.S. Circuit Court of Appeals for the Eleventh Circuit issued its decision in Yates v. Pinellas Hematology & Oncology, P.A. The appellate court affirmed the district court’s imposition of damages and...more

Nelson Mullins Riley & Scarborough LLP

CMS Delays Clinical Laboratory Proficiency Testing Rulemaking by a Year

The Centers for Medicare & Medicaid Services (CMS or the Agency) announced on January 19, 2022 that it was delaying the publication of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rulemaking by one year. ...more

Mintz - Health Care Viewpoints

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

Foley & Lardner LLP

COVID-19: Ten Things to Know about Laboratory Testing

Foley & Lardner LLP on

Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more

Jackson Walker

CMS Eases Laboratory Requirements

Jackson Walker on

In light of the shortage of COVID-19 laboratory testing services, and the overall pressures on the healthcare industry created by responding to the crisis, the Centers for Medicare & Medicaid Services (CMS) have issued...more

King & Spalding

CMS Proposes Sweeping Changes to Medicare Reimbursement for Clinical Diagnostic Laboratory Tests

King & Spalding on

First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...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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