Trending Laboratory News and Insights

Volume XXI

December 2021 - Happy Holidays from LLS!

As we head into the new year, we want to take a moment to say "thank you" for being a dedicated reader of Lab Insighter. This has been an exciting year of growth for our company, and we're looking forward to what 2022 brings as we continue to help keep the clinical laboratory community informed of the latest industry news and trends! Below are our scheduled business hours should you need to contact us during the upcoming holidays.

The Lighthouse Lab Services offices will be closed:

Thursday, Dec. 23, 2021
Friday, Dec. 24, 2021
Friday, Dec. 31, 2021

Full Focus: Examining the FDA's Recent Shift on COVID LDTs

In late November, the U.S. Department of Health and Human Services (HHS) withdrew a policy regarding laboratory developed tests (LDTs) established during the Trump Administration that directed the FDA not to enforce premarket review requirements for LDTs.

However, this sudden shift has left laboratories developing new COVID tests with more questions than answers regarding the steps that now must be taken to receive Emergency Use Authorization (EUA) for their LDTs prior to clinical use.

During this Jan. 26 webinar, we will welcome Gail H. Javitt, Director, Hyman Phelps & McNamara, P.C., to discuss the short-term implications of this change, and what it means for labs developing new tests moving forward.

The Impact of the FDA's Recent Shift on COVID LDTs

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LATEST NEWS

1. Lighthouse's SARS-CoV-2 Assays Detect Omicron Variant

Lighthouse Lab Services has conducted an analysis of all publicly available genetic sequences of the Omicron (B.1.1.529) variant obtained through GISAID–Global Initiative on Sharing All Influenza Data and confirmed that none of the new mutations present in the Omicron variant occur within regions of the genome targeted by Lighthouse’s CovidNow SARS-CoV-2 Assay and SalivaNow SARS-CoV-2 Assay.

This means that Lighthouse’s assays will continue to deliver accurate test results for SARS-CoV-2 infections, as all Lighthouse SARS-CoV-2 assays will detect all known variants, including the Omicron variant.

CLICK HERE to learn more.

2. Trending Issue: Improving Denial Management

Did you know more than 65% of medical claim denials are never worked by billers? Everyone knows denials are a frustrating aspect of running a medical laboratory. Despite their prevalence, however, many can be avoided if you are using the right tools to track them.

To aid in this effort, Lighthouse recently launched RCM Spotlight, a new cloud-based AI software to analyze healthcare payer performance and identify revenue enhancement opportunities. If you're interested in receiving a free custom RCM analysis, please contact us at the link below!

3. Join the Lighthouse YouTube Channel for More Laboratory News!

The Lighthouse Lab Services YouTube channel now has more than 150 subscribers! We are grateful for how our channel has grown this year and are proud of how we help our subscribers stay on top of medical laboratory industry news and updates.

If you're not currently a subscriber, please consider signing up! We have exceptional content that can help you make informed decisions about how to grow your lab and career.

Check out our channel and subscribe!

Pathologists and clinical laboratories received an early Christmas present this month when Congress moved to suspend scheduled Medicare cuts in order to provide financial relief to providers amid the ongoing COVID-19 Public Health Emergency.

Additionally, the legislation calls for next round of Protecting Access to Medicare Act (PAMA) data reporting and associated Clinical Lab Fee Schedule (CLFS) cuts to be delayed one year until 2023. Without the delay, many tests were set to see cuts of up to 15% of 2021 rates.