COVID Laboratory Testing Investigations
On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more
New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
On Dec. 28, 2023, the Centers for Medicare and Medicaid Services (CMS) released a final rule that updates Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies CLIA regulations. CLIA regulates...more
On March 22, 2023, the Centers for Medicare & Medicaid Services (CMS) announced that it will begin sending electronic Clinical Laboratory Improvement Amendments (CLIA) certificates to those laboratories that opt on their CLIA...more
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
Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...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
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
Anyone conducting COVID-19 testing – whether using point of care or high complexity tests – should take note. On August 25, the Centers for Medicare & Medicaid Services (CMS) released an Interim Final Rule with comment period...more
Laboratory Developed Tests and Their Regulation - Laboratory developed tests (LDTs) are in vitro diagnostic tests (IVDs) that are designed, developed, manufactured, and performed within a single laboratory. Although the...more
In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they...more
In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...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 March 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an order suspending standard healthcare facility surveys for a period of three weeks (“the prioritization period”). The only surveys that will be...more
The Centers for Medicare and Medicaid Services has temporarily modified certain operational and regulatory requirements that may help Clinical Laboratory Improvement Amendments (CLIA) certified laboratories adapt their...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more
CMS recently announced a 20 percent increase to the fees that laboratories must pay when certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. This is the first such increase in the last 20 years and...more
Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the...more
On January 22, 2018, the Drug Enforcement Administration (DEA) issued a final rule entitled, Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs...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
Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more
Clinical laboratories will see significant changes to their Medicare payments for clinical diagnostic laboratory tests (CDLTs) starting January 1, 2017, but the basis for new payment rates will come from “applicable data”...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more