Archived News

2020

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

2/12/2020
CMS Update on Coronavirus Assay

2019

December 18, 2019
PAMA Lawsuit - ACLA's Reply in Support of Plaintiff’s Motion for Summary Judgment

December 17, 2019
LAB Act Passes the House

December 13, 2019
Senate Version (S. 3049) of the LAB Act Introduced

December 4, 2019
Over 30 Lab Organizations Sign Letter to Congress Supporting Passage of the LAB Act (H.R. 3584)

November 6, 2019
ALERT: FDA Issues Warning that Biotin may Interfere with Lab Tests, Especially Troponin

September 24, 2019
U.S. Dept. of Labor Issues Final Overtime Rule

September 16, 2019
Announcing NILA's 2020 Lab Leaders Forum and Mid-Winter Meeting

August 2, 2019
Update on ACLA's Successful Appeal in PAMA Lawsuit

July 30, 2019
ACLA's Appeal Upheld

July 19, 2019
LAB Act (HR 3584) Gains Traction: Act Now to Help

June 28, 2019
The Laboratory Access for Beneficiaries (LAB) Act

May 2, 2019
Clinical Diagnostic Laboratories: Resources about the Private Payor Rate-Based CLFS

April 18, 2019
MACs to Remind Labs to Collect and Report Private Payor Data

April 8, 2019
CLIA Proposes Updates to PT Regs

April 1, 2019
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Scheduled to Meeting July 22-23

April 1, 2019
CMS Schedules June 24 Public Meeting Regarding New and Reconsidered Clinical Diagnostic Lab Test Codes

March 26, 2019
Former NILA Member Remembered at Memorial Service

March 1, 2019
NILA Comments on CMS's Proposal to Increase CLIA Fees

January 7, 2019
Government Shutdown Delays Decision on Appeal of PAMA Lawsuit

January 2, 2019
HHS Releases Voluntary Cybersecurity Practices for the Healthcare Industry

2018

December 31, 2018
CMS Proposes 20% Increase to CLIA Fees

December 18, 2018
NILA Amends Statement Regarding GAO Report

December 17, 2018
GAO Report on Implementation of PAMA Fails to Base Recommendations on Facts

December 11, 2018
AAB Files Amicus Brief Supporting ACLA's PAMA Lawsuit Appeal

November 5, 2018
Changes to PAMA in the CY 2019 PFS Are Insufficient Says NILA

October 22, 2018
ACLA Files Notice of Appeal Regarding Denial of its Motion for Summary Judgement

September 24, 2018
Court Denies Motion for Summary Judgement In ACLA's PAMA Lawsuit

September 20, 2018
Office of Inspector General Posts Study of CLFS Payments in 2017

September 11, 2018
Curbing Drug Addiction and the Opioid Crisis, NILA White Paper, Press Release

September 10, 2018
AAB/NILA Comments to CMS Regarding Revisions to the Physician Fee Schedule for CY 2019

September 7, 2018
PAMA Laboratory Fee Schedule Cuts were Determined Using an Illegal Methodology Says NILA

August 7, 2018
36 Societies Forward Letter Asking Congress To Fix PAMA

August 7, 2018
NILA’s Key Informant Report About Impact of PAMA Cited in Forbes Op-Ed

July 13, 2018
CMS Releases Proposed Changes to the Physician Fee Schedule and Quality Payment Program

July 5, 2018
Laboratory Date of Service Exception

June 28, 2018
NILA Announces 2019 Lab Leaders Forum and Mid-Winter Meeting

May 2, 2018
NILA Report Reveals PAMA’s Adverse Impact on Community, Regional Labs, and Patient Access

April 4, 2018
CMS's Annual Laboratory Public Meeting to be held June 25, 2018, in Baltimore, Maryland

March 23, 2018
CMS Files Cross-Motion for Summary Judgment in PAMA Lawsuit

March 15, 2018
AAB and NILA Respond to RFI Issued by the House Ways and Means Committee Regarding the Opioid Crisis

March 9, 2018
NILA submits comments in response to CMS’ RFI regarding CLIA revisions

March 9, 2018
NILA and 12 Other Lab Groups Forward Letter to CMS Opposing Medicaid Fee Schedule Cuts

March 5, 2018
NILA Signs Addiction Policy Forum Letter

February 21, 2018
AAB/NILA Files Amicus Brief in PAMA Lawsuit

January 4, 2018
2018 Travel Allowance Rate Announced by CMS

January 2, 2018
Congressman Krishnamoorthi (D-IL) Asks CMS to Delay and Fix PAMA Regulations

2017

December 27, 2017
Seven Senate Finance Committee Members Express Concerns About PAMA’s CLFS Cuts for 2018

December 11, 2017
ACLA Files Lawsuit Challenging PAMA Rate Setting Method

November 18, 2017
Final 2018 CLFS Payment Rates Flawed

November 6, 2017
Eight Senators Sign Letter to CMS Secretary Verma Regarding PAMA

October 23, 2017
NILA/AAB Submit Comments on the 2018 Medicare Part B CLFS Proposed Rates

October 6, 2017
22 Organizations Sign Letter to CMS Administrator Seema Verma Urging Suspension of Proposed PAMA Cuts

September 22, 2017
NILA Issues Press Release on Proposed 2018 Medicare CLFS Rates

September 12, 2017
NILA Submits Comments Calling for Changes to PAMA Regulations

August 11, 2017
NILA Comments – Advisory Panel Meeting on Clinical Diagnostic Laboratory Tests

July 21, 2017
CMS Issues Agenda, Code List for July 31 CLFS Public Meeting

July 17, 2017
CMS Requests Feedback from Labs as Part of Physician Fee Schedule Rule

March 30, 2017
Deadline for Reporting PAMA Private Payor Data Extended to May 30, 2017

March 24, 2017
NILA Leads Lab Groups in Calling for Delay and Fix of PAMA

February 27, 2017
New Professional and General Liability Insurance

January 13, 2017
FDA Releases Discussion Paper on Oversight of LDTs

January 10, 2017
CMS Releases Guidance for Submitting Private Payor Data as Required by PAMA

2016

December 15, 2016
NILA Press Release: NILA Applauds House Freedom Caucus Recommendation on Immediate Repeal of Medicare Lab Payment Reform Rule

November 23, 2016
Final Determinations for Repricing Definitive Drug Tests

November 23, 2016
FDA Drops Guidances for LDTS  

November 9, 2016
NILA Press Release: Eighty-Eight Members of Congress Sign Bipartisan Letter to HHS Requesting Delay of PAMA

November 7, 2016
Final Bipartisan Sign-On Letter Regarding PAMA Implementation

October 5, 2016
OIG Releases Reports on Medicare Payments for Lab Tests in 2015; Update on CMS’s Progress on Changing How Medicare Pays for Lab Tests

September 12, 2016
NILA Comments on Hospital Outpatient Prospective Payment System (HOPPS)

August 24, 2016
CMS Releases HCPCS Codes to be Reported Under PAMA

August 18, 2016
PAMA Advisory Panel to Meet September 12, 2016

August 17, 2016
FDA Releases Guidance: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus

August 9, 2016
NILA Comments to Support Reconsideration for Final Payment Determinations for Toxicology Codes G0840, G0481, G0482, G0483

August 4, 2016
Medicare Advisory Panel Votes in Favor of NILA's Reconsideration Requests for Toxicology Codes G0480, G0481, G0482, G0483

July 7, 2016
FDA Releases Draft Guidances for Next Generation Sequencing-based Tests

July 6, 2016
HHS announces new actions to combat opioid epidemic

June 30, 2016
NILA Requests CMS to Allow Reconsideration of Tier 1 Codes (G0480)

June 23, 2016
Final PAMA Regulations Published in Federal Register

June 18, 2016
NILA Comments on PAMA Regulations

June 17, 2016

 

Final PAMA Regulations Released

 June 3, 2016
Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting on July 18, 2016

April 14, 2016
NILA Requests Meeting With CMS to Discuss PAMA Regulations

March 29, 2016
Bipartisan Group of 26 House Ways & Means Committee Members, Including More Than Half of the Ways & Means Health Subcommittee, Urge CMS Not To Rush PAMA Regulations   

March 28, 2016
Authorization of Emergency Use: In Vitro Diagnostic Device for Diagnosis of Zika Virus Infection 

March 17, 2016
May 2, 2016, Workshop on LC/MS-Based Devices 

March 3, 2016
Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus

February 1, 2016
AAB's Resource Center for Zika Virus

January 18, 2016
NILA Files Reconsideration Request for CMS’s Drug Coding/Payment Policy   

January 11, 2016
FDA Releases Draft Guidance: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

January 7, 2016
Senators Hatch (R-UT) and Wyden (D-OR) Urge CMS to Delay PAMA Reporting System

2015

December 17, 2015
44 U.S. Representatives Sign Letter Regarding CMS’s Proposed PAMA Regulations

December 15, 2015
19 Senators Sign Letter Regarding CMS’s Proposed PAMA Regulations

December 7, 2015
NILA Comments on LCD “MolDX: Biomarkers in Cardiovascular Risk Assessment”   

November 24, 2015
NILA Comments on CLFS Proposed Payment System (PAMA Regs)   

November 24, 2015
New York Bill Vetoed Requiring NY Personnel Laws to be Applied Nationwide   

November 24, 2015
11/10/15 MLN Connects National Provider Call on Clinical Diagnostic Lab Test Payment System Proposed Rule (Transcript)

November 23, 2015
NILA Comments on New CMS Payments for Drug Tests   

November 18, 2015
CMS Issues Final Coding / Pricing For Drug Test Codes in CY 2016   

November 17, 2015
The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies

October 26, 2015
NILA Comments On 2016 Clinical Laboratory Fee Schedule (CLFS) Coding and Pricing Determination For Toxicology Testing.   

October 26, 2015
NILA and 7 Other Health Care Organizations Forward Letter To Senate and House Regarding CLIA Modernization and Oversight of LDTs   

October 26, 2015
Hearing of House Energy and Commerce Subcommittee on Health will be held on Thursday, October 29, 2015, at 10:00 a.m. in 2123 Rayburn House Office Building. The hearing is entitled “Examining the Regulation of Diagnostic Tests and Laboratory Operations" is Postponed Until November 17.   

October 8, 2015
CMS Announces PAMA Advisory Panel Meeting on October 19, 2015  

September 29, 2015
NILA Press Release on Proposed PAMA Regulations   

September 28, 2015
California Assembly Bill No. 940   

​September 25, 2015
​CY 2016 Clinical Laboratory Fee Schedule Determinations 

September 25, 2015
Proposed PAMA Regulations Released

September 10, 2015
New Medicare Policy for CV Risk Assessment Panels 

August 28, 2015
Laboratory-developed tests are not the practices of medicine (article via MLO)

August 7, 2015
CMS Announces PAMA Advisory Panel on Clinical Lab Tests

June 19, 2015
New York State Legislature Passes Bills Governing Credentials of Out-of-State Laboratories Testing Specimens from New York Residents

June 17, 2015
CMS Public Meeting on CY 2015 Updates to the Part B Clinical Laboratory Fee Schedule (CFLS)

June 1, 2015
CCLA Lawsuit Regarding Local Coverage Determinations Dismissed (via Pathology Blawg)

May 22, 2015
Palmetto GBA Policy on Next Generation Sequencing (via Palmetto GBA)

February 23, 2015
AAB and NILA Release Comments on HELP Committee Report 

February 4, 2015
AAB and NILA Release Comments on FDA's Draft Guidances on LDTs

January 5, 2015

NILA Comments on 21st Century Cures Diagnostic Tests Initiative

   

 

2014

November 3, 2014
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems

November 3, 2014
CMS Publishes Physician Fee Schedule Final Rule

September 8, 2014
NILA Comments on 2015 Medicare Physician Fee Schedule Proposed Rule   

July 11, 2014
Summary of Calendar Year 2015 Physician Fee Schedule (PFS) Proposed Rule 

July 11, 2014
OIG Report on Laboratory Billing Provides More Questions Than Answers   

June 25, 2014
Special Fraud Alert: Laboratory Payments to Referring Physicians

June 6, 2014