In This Issue:



• Previewing our June 24 webinar on the relationship between FDA regulation and payer reimbursement for lab testing.
• Why AI is poised to make clinical labs the most important healthcare sector.
• Exploring growing demand for direct-to-consumer testing and the opportunity for labs.
• Our latest most placeable candidate spotlight.
• A new RCM white paper discussing the value of protecting earned revenue through a proactive auditing approach.
• New strategic partnership with Lab Symplified.
• And more.

Upcoming Webinar: From FDA Review to Payment - Understanding the Connection Between Reimbursement and Regulation

For many laboratories, regulatory and reimbursement decisions are no longer separate conversations. FDA pathways, intended use claims, clinical utility evidence, and payer expectations are becoming increasingly interconnected, creating new opportunities and challenges for test developers and laboratory leaders.

Join Christine Bump of Penn Avenue Law and Ann Lambrix of Lighthouse Lab Services at noon EDT, Wednesday, June 24, for a discussion on how regulatory strategy can influence coverage and reimbursement outcomes. Topics will include FDA review considerations, the distinction between intended use and clinical utility, Medicare coverage developments, and emerging reimbursement trends affecting molecular diagnostics.

The webinar will also explore recent changes within the MolDx program and what they may signal for the future of coverage and reimbursement for advanced diagnostic testing.

Who should attend: Laboratory owners, executives, reimbursement professionals, compliance leaders, and anyone involved in bringing new clinical tests to market.

VIEW HERE

New Proposal Would Modernize CLIA and LDT Oversight

A potentially significant development that would modernize CLIA is worth monitoring for clinical labs.

Congressman Neal Dunn recently introduced the Enhancing Clinical Laboratory Innovation and Access Act, legislation intended to modernize the regulatory framework surrounding clinical laboratories and emerging diagnostic technologies. The proposal aims to update oversight structures originally established decades ago to better align with today's diagnostic environment. 

For lab stakeholders navigating ongoing conversations around LDT oversight, digital pathology, genomic analysis, and advanced diagnostics, this legislation could influence how innovation and regulation intersect moving forward.

Some notable provisions under the proposed bill include:

🔹Reaffirming CMS oversight of laboratory developed tests (LDTs) under CLIA

🔹Creating a publicly accessible database with LDT performance and validation information

🔹Expanding recognition of newer diagnostic approaches, including digital and genomic analyses

🔹Establishing voluntary third-party validation pathways

🔹Strengthening centralized reporting and oversight mechanisms when concerns arise 

Since the defeat of the VALID Act, the broader discussion around LDT regulation has remained active across the laboratory industry. This legislation appears to be the next development for laboratory leaders, pathologists, and diagnostic organizations to continue to watch closely as it progresses.

Why AI Makes Clinical Labs the Most Important Sector in Healthcare

For years, the clinical diagnostic laboratory industry has quietly operated as the foundation of modern medicine, providing the data physicians use to diagnose disease, monitor treatment, and guide care decisions. But a major shift is beginning to emerge.

As artificial intelligence becomes increasingly integrated into healthcare, diagnostic laboratory testing may become one of the most valuable and strategically important components of the entire healthcare system.

Read insights from LLS Founder Jon Harol HERE>

As Consumers Take Testing into Their Own Hands, Labs Look to Capitalize (360Dx article)

As wellness and telehealth firms announce new direct-to-consumer testing options to support their patients' demands and provide broader access to clinical lab data, clinical laboratories are seeing new opportunities in the DTC space outside of more traditional medical channels. The segment is still relatively small, but it is growing as labs develop their own consumer businesses and payer relationships with firms in the telehealth and wearables space.

"Patients really want to be in control of their own destiny," said Ellen Beausang, President and CRO of Lighthouse Lab Services. "The COVID-era normalized direct-to-consumer and patient-initiated testing. We are absolutely seeing clear trends where patients want direct access to testing."

Read the full article HERE> (subscription required)

Lighthouse Instrument Service Team Celebrates Strong Customer Reviews

For laboratory owners and healthcare decision-makers, instrument service shouldn't be viewed as simply a cost center. Instead, it's a risk management strategy.

Recent feedback from our Instrument Service customers resulted in an average satisfaction score of 4.7 out of 5, including high marks for responsiveness, professionalism, resolution times, and post-service instrument performance.

Thank you to our customers for the feedback and continued partnership. If you're currently evaluating instrument service providers or have a contract coming up for renewal, we'd love to share more about what makes our Field Service Engineers best-in-class.

The Lighthouse "Candidate Corner" is a recurring monthly spotlight featuring some of the great lab professionals our recruiters work with each day. Check out a quick preview of one individual below, then click over to our blog to see all five candidates for June.

If you'd like to learn more about anyone listed in this section or inquire about their ability to relocate, email us directly here!

Candidate: Lab Supervisor / Manager

• Education: 
• M.S. in Medical Laboratory Science

• Certification:
• MLS(ASCP)

• Preferred Location:
• Dallas, TX
• Raleigh, NC
• Charlotte, NC
• Atlanta, GA

View all candidates HERE>

New White Paper: How Labs Can Proactively Protect Earned Revenue

Growth initiatives frequently focus on new service lines, new clients, or expanded testing capabilities. RCM audits focus on something different: protecting and strengthening existing revenue opportunities. A targeted billing audit is an opportunity to uncover inefficiencies, strengthen workflows, and protect revenue that may already be slipping through the cracks.

In this new white paper, our RCM Consulting experts dive into four key areas of the revenue cycle process where revenue routinely slips through the cracks.

Download the PDF HERE> 

On-Demand Webinar: Reducing Denials in Molecular Testing

While multiplex molecular testing offers reference laboratories and hospitals powerful capabilities for pathogen detection, navigating the payer landscape can be just as complex as the science behind the panels. For labs running multiplex molecular panels, reimbursement denials remain a persistent challenge—but there are strategies to overcome the most common denial drivers: coverage, documentation, and coding practices that are not aligned with payer requirements.

During this session, Ann Lambrix, Executive Director of RCM Consulting at Lighthouse Lab Services, delivers a practical, real-world perspective on overcoming reimbursement challenges in molecular multiplex testing.

Watch now HERE>

Lighthouse Lab Services is excited to announce a strategic partnership with Lab Symplified, a laboratory operations software platform designed to help laboratories improve inventory management, strengthen compliance efforts, and streamline day-to-day operations.

As laboratories face increasing pressure to manage costs, maintain compliance, and operate efficiently with limited resources, many organizations continue to rely on manual processes for inventory tracking and quality-related workflows.

"Laboratories are constantly looking for ways to improve efficiency without compromising quality or compliance," said Elliot Labovitz, Chief Sales Officer for Lighthouse Lab Services. "Lab Symplified offers a practical solution for inventory and quality management challenges that many laboratories face, and we're excited to bring this resource to our clients and industry partners."

Read the full announcement HERE>

Association for Diagnostics and Laboratory Medicine 2026

• July 26-30, 2026
• Anaheim, CA
• Learn more here

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