NILA News

9/20/2021
PAMA Recommendations Delivered to Capital Hill

8/23/2021
NILA Comments on the VALID Act of 2021 (H.R.4128/S.2209)

7/16/2021
NILA Comments on Lab Provisions in Draft of CURES Act 2.0

6/24/2021
NILA Statement on the VALID Act

6/11/2021
NILA Writes Letter to Secretary Becerra Regarding Federal Oversight of LDTs

6/4/2021
NILA and AHA Urge NAIC to Take Action on UnitedHealthcare Designated Diagnostic Provider (DDP) Program

5/14/2021
NILA Letter to MedPAC Regarding PAMA Fee Schedule Calculations

4/29/2021
NILA, AAB and Partners Request $60M for Advanced Molecular Detection (AMD) Program

1/15/2021
NILA Supports President-Elect Biden’s Plans to Expand and Improve COVID-19 Testing Supplies

12/21/2020
NILA Comments on CMS Rules for Posting COVID-19 Pricing Data

12/2/2020
Lab Group Letter to Biden Transition Team regarding COVID-19 Supply Shortage

11/21/2020
FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

11/20/2020
FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

11/19/2020
FDA Authorizes Drug Combination for Treatment of COVID-19

11/18/2020
Waste Management Guidance for SARS-CoV-2 Point-of-Care Testing

11/17/2020
NILA’s Letter to CMS Regarding Changes to Reimbursement for COVID-19 Diagnostic Tests

CDC Releases 6th Edition of Biosafety in Microbiology and Biomedical Laboratories

11/16/2020
FDA Update on FAQs on Testing for SARS-CoV-2

11/13/2020
CDC Updates FAQs to Include Information on Cycle Threshold Value

11/12/2020
CMS IQCP Clarification for EUA Tests

11/11/2020
CMS Takes Steps to Ensure Medicare Beneficiaries Have Wide Access to COVID-19 Antibody Treatment

11/3/2020
CDC Updates Specimen Collection Guidelines for COVID-19

11/2/2020
NILA’s Comment Letter Regarding the Interim Final Rule on COVID-19 Test Result Reporting

10/26/2020
Upcoming CLIAC Meeting on October 28-29, 2020

10/19/2020
NILA Questions FDA Decision to Suspend EUAs for COVID-19 LDTs

Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

10/15/2020
CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

CDC Publishes New Web Page on Point-of-Care Testing for COVID-19

10/7/2020
NILA/AAB and Four Other Lab Groups Ask Pandemic Task Force to Address COVID-19 Supply/Reagent Shortages

10/5/2020
NILA Members Report Continued Supply Shortages, Potential Increased COVID-19 Testing Capacity

Guidance for LOINC In-Vitro Diagnostic (LIVD) Code Selection for Laboratories Using Laboratory-Developed Tests

10/2/2020
FDA Updates the SARS-CoV-2 Reference Panel Comparative Data

10/1/2020
CSTE Posts New Electronic Laboratory Reporting Points of Contact for COVID-19

CMS Releases New Laboratory Quick Start Guide for CMS CLIA Certification

9/24/2020
NILA's September 18 Letter to MedPAC Regarding MedPAC's Review of PAMA (PDF)

9/23/2020
Lab Advisory: LOINC In-Vitro Diagnostic (LIVD) Codes for SARS-CoV-2 Antigen Tests

9/22/2020
CDC, APHL and CSTE Standardized ELR Flat File

9/18/2020
CDC Updates Guidance on Testing for SARS-CoV-2

9/9/2020
U.S. FDA Update - FAQs on Testing for SARS-CoV-2

9/3/2020
CMS Issues New Surveyor Guidance for SARS-CoV-2 Laboratory Test Result Reporting

8/31/2020
Join the Next Clinical Laboratory COVID-19 Response Call Today, August 31 at 3:00 PM EDT

8/29/2020
CMS Publishes New CLIA FAQs

8/26/2020
CMS Issues New Rule for SARS-CoV-2 Laboratory Test Result Reporting

8/24/2020
FDA FAQ Update: New Information on Testing for SARS-CoV-2

8/18/2020
NILA Applauds CRL for Launching Saliva-Based COVID-19 Test

8/16/2020
CDC LOCS Lab Advisory: New COVID-19 Antigen Testing Guidance

CDC LOCS Lab Update: FDA Updates FAQs about Testing for SARS-CoV-2

CDC LOCS Lab Alert: Report False Negatives and False Positives from COVID-19 Testing & Review New Frequently Asked Questions

8/13/2020
Joint Commission Revising Several Laboratory Accreditation Requirements

8/10/2020
CDC Responds to NILA Request that Record Reporting Requirements for COVID-19 Tests be Reconsidered

8/5/2020
CDC Updates Reporting FAQs for COVID-19 Testing

7/31/2020
Update on COVID-19 Laboratory Reporting Requirements

HEALS Act Introduced - Read NILA's Summary

7/28/2020
FDA Issues COVID-19 Testing and Policy Updates

CMS Updates Data on COVID-19 Impacts on Medicare Beneficiaries

7/24/2020
CDC Releases New Test Pooling Guidance for SARS-CoV-2

7/23/2020
CDC Publishes Primers and Probes for Research Use Only SARS-CoV-2 Multiplex Assay

CDC Releases New Test Pooling Guidance for SARS-CoV-2

7/22/2020
Update on Laboratory Reporting Guidance for SARS-CoV-2

7/18/2020
FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

7/16/2020
NILA Letter to HHS Secretary Azar Requests Delay in Implementation of Lab Data Reporting Guidance

FDA Releases New Information on Testing for SARS-CoV-2

7/11/2020
CDC Publishes New General Laboratory Safety Guidance

7/10/2020
Laboratory Stakeholders Ask Administration to Improve Access to Testing Supplies

7/9/2020
CDC Multiplex Assay Receives Authorization from FDA

7/8/2020
Letter to VP Pence from NILA and other organizations addressing demand for COVID-19 testing supplies

7/7/2020
FDA Letter Warns of False Positive Results with BD SARS-CoV-2 Reagents for the BD Max System

7/6/2020
NILA’s Comments on Palmettos LCD for Toxicology

7/1/2020
DOT Issues Safety Notice for Transportation of COVID-19 Diagnostic Samples

Burkholderia pseudomallei in Southwestern United States

6/29/2020
FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2

6/26/2020
NILA Letter to Senator Alexander Regarding Future Pandemics

6/20/2020
FDA Updates Website, Issues Warning Letters, and Revokes Chembio EUA

6/19/2020
Detection of Ciprofloxacin-resistant, β-lactamase-producing Neisseria meningitidis Serogroup Y Isolates

6/12/2020
CDC Updates Laboratory Biosafety Guidelines and Questions & Answers

6/10/2020
FDA Posts Information from Independent Evaluations of COVID-19 Serological Tests

6/6/2020
HHS Issues New CARES Act Guidance

6/1/2020
Lab Alert: Molecular Transport Media (MTM) and Cyanide Gas

5/27/2020
CDC Releases Interim Guidance for Coronavirus Disease (COVID-19) Antibody Testing

5/22/2020
FDA Removes Several COVID-19 Antibody Tests and Provides Additional Information

5/11/2020
CDC Weekly Call with Clinical Labs Audio and Transcript

5/9/2020
New COVID-19 Data Tracker Website for Laboratories

5/7/2020
Updated LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Test Results

5/6/2020
Lab Advisory: CDC Posts New Information about Serology Testing for COVID-19

CMS Issues Updated COVID-19 Frequently Asked Questions about Medicare Fee-for-Service Billing

5/5/2020
FDA Updates Policy about Serology Tests for COVID-19

5/4/2020
CDC Weekly Call with Clinical Labs Audio and Transcript

FDA Releases Revised Policy for COVID-19 Serology Testing

5/2/2020
CDC Releases Test Code Mapping Guide

5/1/2020
CMS Issues Additional Guidance on SARS-CoV-2 Laboratory Testing

4/28/2020
Trump Administration Releases COVID-19 “Testing Overview” and “Testing Blueprint”

4/27/2020
CDC Weekly Call with Clinical Labs Audio and Transcript

4/24/2020
NILA’s letter to CMS about reimbursement rates for antibody tests

4/22/2020
NILA Releases White Paper on Importance of Proficiency Testing for COVID-19

4/20/2020
CDC Weekly Call with Clinical Labs Audio and Transcript

AAB/NILA letter to FDA and CMS regarding COVID-19 testing

4/15/2020
CMS Increases Medicare Payments for COVID-19

4/13/2020
Lab Advisory: Updated Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

CDC Weekly Call with Clinical Labs Audio and Transcript

4/10/2020
AAB/NILA Response Letter to Senators Duckworth, Durbin, and Markey, Regarding COVID-19

4/9/2020
Laboratory Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations

4/6/2020
CDC Weekly Call with Clinical Labs Audio and Transcript

4/1/2020
Laboratory Advisory: Updated Clinical Guidance on Testing Persons for Coronavirus Disease (COVID-19)

3/30/2020
CDC Weekly Call with Clinical Labs Audio and Transcript

Trump Administration Engages America’s Hospitals in Unprecedented Data Sharing

Trump Administration Provides Financial Relief for Medicare Providers

3/27/2020
The CARES Act Provides Temporary, but Not Immediate Relief to Clinical Laboratories

3/26/20
Senate Passes Stimulus Package with Relief for Clinical Laboratories

CMS Issues CLIA Guidance and FAQs for Laboratories During the COVID-19 Pandemic

3/24/2020
URGENT: NILA Members Call Your Senators Today

3/23/2020
CDC Weekly Call with Clinical Labs Audio and Transcript

3/21/2020
CDC Posts New Standard Operating Procedure for Creating Viral Transport Media

Discontinue Use of the A549/MV1LU Mix for Respiratory Viral Culture Panels and Review Updated Biosafety FAQs

3/20/2020
NILA's COVID-19 Stimulus Request Letter to Capitol Hill

Supplies Needed for COVID-19 Testing

3/19/2020
CDC to Convene Clinical Laboratory COVID-19 Response Weekly Calls Beginning on Monday, March 23, 2020 at 3:00 PM ET

3/17/2020
Change to Result Interpretation for CDC EUA Assay

3/15/2020
Lab Advisory: Updated Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19)

3/12/2020
COVID-19 Lab Letter to Vice President (PDF)

3/10/2020
CDC Updated Guidance on Testing Persons for Coronavirus Disease 2019 (COVID-19)

FDA releases FAQs on Diagnostic Testing for SARS-CoV-2 (COVID-19)

U.S. Department of Labor Offers Guidance For Preparing Workplaces for Coronavirus

3/9/2020
Coronavirus testing rollout marred by confusion and false starts (Yahoo! News)

3/5/2020
Lawmakers introduce legislation to expand nation’s diagnostic testing capabilities

Proper Handwashing Technique

3/4/2020
COVID-19 Public Health Reporting for Laboratories that Develop or Use Laboratory Developed Tests with Intent to Obtain EUA

3/2/2020
FDA Guidance to Develop Novel Molecular Diagnostic Tests for SARS-CoV-2

Laboratory Biosafety COVID-19 Frequently Asked Questions

2/27/2020
Criteria to Guide Evaluation of Person Under Investigation (PUI) for COVID-19

2/25/2020
Update: Public Health Response to the Coronavirus Disease 2019 Outbreak

2/24/2020
Public Health Response to the Coronavirus Disease 2019 Outbreak

2/21/2020
Frequently Asked Questions about Biosafety & COVID-19

2/18/2020 (from CRB)
Important FDA Notification Regarding Coronavirus

Archived News

Click here to see NILA's archived news.