Volume XXII
January 2021 - Top Stories:

1. Full Focus: What New FDA LDT Rules Mean for COVID Testing

The clinical laboratory industry received a shock late last year when the U.S. Department of HHS announced it would again direct the FDA to enforce premarket review requirements for COVID-19 Laboratory Developed Tests (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
LATEST NEWS
1. Is Your Lab Looking to Add COVID Testing Amid the Omicron Surge?

As Omicron continues to spread across the U.S., it’s important to consider either extending the offer of COVID-19 testing in-house or adding COVID testing to your lab’s menu if you haven’t already. This service is vital as the nation continues to hit record numbers of cases.

The Lighthouse mission is making quality lab testing more accessible, and we'd love to serve your laboratory by providing the testing lines you need to serve your community.
SalivaNow and CovidNow assays are now available from LLS
2. How Part-Time Lab Director Services Can Benefit Your Laboratory

Our Part-Time Lab Director Services are a great way to keep your lab running smoothly and compliantly without the administrative headache. But how do our services work, and why should you choose them over other, similar services in the industry?

In our latest video, Tara Luellen, Vice President of Lab Director Services, explains why this service is useful for medical labs, what differentiates us from our competitors, and how it can help your lab achieve its goals.

3. The Most Important Positions in Any Medical Testing Lab

Every medical testing lab requires professional and experienced staff to function properly. Each staff member specializes in certain procedures and processes that are essential for diagnosing, treating, and preventing diseases.

How Labs Can Utilize COVID Vaccine Coverage Assistance
Did you know there are steps your lab can take to become eligible to administer COVID-19 Vaccines? However, labs approved to administer the vaccine will eventually learn not all payers and plans reimburse the full Medicare rate per dose. Fortunately, the COVID-19 Coverage Assistance Fund is available to reimburse providers whose vaccine administration claims are either denied or partially paid.
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“Unfortunately, our client has experienced that not all payers fully reimburse the $40 for administering the vaccine. They recently asked for help to see if they could balance bill the remainder to the Health Resources and Services Administration (HRSA), and I found there is indeed funding available through the COVID-19 Coverage Assistance Fund.”

-- Tami Shaw, Client Manager, Lighthouse Lab Services/Vachette
The following article examines:

  • Steps required to become a registered Mass Immunizer with CMS.
  • Payment rates for administering COVID-19 Vaccines.
  • How to access the Coverage Assistance Fund when claims are partially paid or denied.
UPCOMING CONFERENCES WE'RE ATTENDING
1. Florida Society of Pathologists 48th Annual Pathology Conference

Feb. 18-20, 2022 in Orlando, Fla.
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The Lab Insighter is a monthly publication for Lab Owners and Decision Makers.