COVID Laboratory Testing Investigations
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
On this episode of the HealthLaw HotSpot, host Ericka Adler, Roetzel shareholder and Health Law Practice Group Leader, is joined by fellow Roetzel attorney Christina Kuta to discuss laboratory testing investigations related...more
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
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
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
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
Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these...more
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
On Saturday, 29 February 2020, the U.S. Food and Drug Administration (FDA) issued an “immediately in effect guidance” to swiftly expand testing for the novel coronavirus (2019-nCoV, formally named SARS-CoV-2), the causative...more
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
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