Compliance

HHS OIG: Labs with Questionably High Billing for Add-On Tests Warrant Further Scrutiny

Certain labs billed Medicare Part B for questionably high levels of add-on tests alongside COVID-19 tests in 2020.

Compliance

Fast Facts: Your Guide to the VALID Act

The bipartisan VALID Act would implement a risk-based review system for all diagnostic tests, including LDTs, under the FDA.

Compliance

COLA Launches Toolkit for Waived Laboratories

COLA’s Waived Testing Toolkit provides guidance and tools to help staff achieve and maintain waived testing excellence, including guidance on covid-19 reporting.

FDA Updates FAQs on Testing for Covid-19

Nov 16, 2020 | Compliance, Covid 19

The changes make it easier to navigate to questions by topic.

FDA Issues New Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests

Oct 13, 2020 | Compliance, Covid 19, Flu & Respiratory Infections

The FDA has issued and immediately implemented a new guidance: Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.

FDA Virtual Town Halls for Labs, Manufacturers of Covid-19 Diagnostics

Oct 5, 2020 | Compliance, Covid 19

Today, the FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-CoV-2.

New CMS Resource Helps Labs Apply for CLIA Certification

Oct 1, 2020 | Compliance

The “Laboratory Quick Start Guide for CLIA Certification” outlines all of the necessary steps laboratories must follow.

CMS Releases New Tools to Streamline Certification for Labs Testing for COVID-19

Sep 28, 2020 | Compliance, Covid 19

CMS’s quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process.

CMS Posts New Covid-19 Testing Requirements for Labs, Nursing Homes

Aug 28, 2020 | Compliance, Covid 19

A memo recommends that facilities conducting patient lab tests use authorized detection antigens to prevent the spread of covid-19 in nursing homes.

FDA Posts New Web Page for Covid-19 Testing

Aug 25, 2020 | Compliance, Covid 19

The page offers resources such as emergency use authorization templates and FAQs regarding surveillance testing and the testing of asymptomatic individuals.

CMS Approves COLA for Virtual Laboratory Surveys

Aug 14, 2020 | Accreditation, Compliance

The virtual laboratory survey process consists of three parts: documentation, review, and a video conference.

FDA Posts New Template for Covid-19 Diagnostics for Non-Lab Settings

Jul 30, 2020 | Compliance, Covid 19

The template will help developers submit EUA requests for covid-19 diagnostics that can be performed entirely in settings such as homes, offices, or schools.

FDA Virtual Town Hall for Clinical Labs, Manufacturers

Jul 28, 2020 | Compliance, Covid 19

On July 29, the FDA will host a virtual Town Hall for clinical labs and commercial manufacturers involved in developing diagnostic tests for SARS-CoV-2.

FDA Updates Templates for Serology Test EUA Requests

Jun 26, 2020 | Compliance, Covid 19

The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.

Managing Prior Authorizations with Artificial Intelligence

Apr 13, 2020 | Compliance, Computing Systems, Information Technology, Lab Management, Middleware & Software

AI-driven software can help labs expertly navigate the prior authorization landscape.

FDA Proposes to Reclassify Two Types of Hepatitis C Virus Diagnostic Tests

Apr 8, 2020 | Compliance, Infectious Diseases, Lab Management, Molecular Diagnostics

If the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.