CMS Releases Interim Final Rule for COVID-19 Reporting and Outlines Enforcement Mechanisms
Interim final rule (CMS-3401-IFC) from CMS mandates daily reporting for broader surveillance of COVID-19 and influenza statistics, and outlines strict enforcement mechanisms.
Airports Offer COVID-19 Testing, Opening More Partnership Possibilities for Clinical Laboratories
Cost points and challenges emerging from new airport COVID-19 testing models.
CMS Sends Cease and Desist Letters to 171 Clinical Laboratories Without Correct CLIA Certification
Rollout and availability of rapid SARS-CoV-2 antigen tests opens wave of CLIA certification issues triggering CMS cease and desist letters.
New Reporting Requirements May See Some Clinical Labs Having to Return Provider Relief Fund Payments
Proactive steps for healthcare providers, such as clinical laboratories, to prevent a new HHS penalty related to the CARES Act funding they received.
Potential New Demand and Partnership Opportunities for Clinical Laboratories as Airlines Begin Offering COVID-19 Testing to Travelers
Key points from three major US airlines offering COVID-19 testing as a way to spur air travel in US.
FDA Issues Letter to Healthcare Providers as Patient COVID-19 Self-Collection Affects Specimen Quality
Three teaching points for self-collecting SARS-CoV-2, COVID-19 specimens; FDA cautions healthcare providers about poor specimen quality.
SARS-CoV-2 Viral Load in Patients Seems to Be Decreasing Over Time New Research Shows
Highlights of a Wayne State University study that seeks to shed light on how viral load measurements are evolving with SARS-CoV-2 and the potential impact on mortality.
5 Critical Questions Posed in New CDC SARS-CoV-2 Airborne Transmission Guidance
Five critical questions that must be answered in order to refine SARS-CoV-2 airborne transmission guidance.
New CMS Guidelines Permit SARS-CoV-2 Antigen Tests for Asymptomatic Patients
Quick links to clarification of CMS policy for clinical laboratories and updated FDA recommendations to healthcare providers about antigen testing of certain asymptomatic individuals.
Thousands of Volunteer Scientists Mobilize to Provide Potentially Valuable Resource for Clinical Laboratories
Interview with Michael F. Wells, PhD, on growth of a national network of volunteer scientists to assist with COVID-19 clinical laboratory testing and more.