Volume XXVI
June 2022

Full Focus: Exploring Concerns Surrounding the VALID ACT

The Verifying Accurate Leading-edge IVCT Development (VALID) Act would establish a new category of clinical lab tests comprised of test kits and laboratory developed tests (LDTs), while also granting the FDA authority to review and approve them pre-market. If enacted, this legislation could have a significant impact on the ability of clinical laboratories to provide innovative tests to patients in a timely manner through longstanding CLIA regulations for LDTs.

Please join us on Tuesday, June 28 at noon EDT for this webinar as we welcome Erin Morton, Senior Vice President, and Meghan Riley, Vice President, of Washington, D.C.-based CRD Associates to provide an overview of the VALID Act and where the legislation currently stands. We will also provide an update on action steps labs can take to oppose this legislation to help ensure they're able to continue providing cutting edge medical care to the patients they serve.
1. Three Key Benefits of Building an In-House Lab

While there are certainly cost and quality improvements to be realized from building an in-house lab, the primary benefit for any physician office is that the decision improves patient care by granting physicians more control of their testing process while ensuring quality results and good turnaround times.

Curious if moving your testing in house may be the right move for your lab? The following article outlines three major benefits of building and operating your own in-house lab.

2. Medicare Advantage Payors to Require DEX Z-Codes

Currently, there is not a list of Medicare Advantage Payors requiring the use of DEX Z-Codes. If you have been notified by your Medicare Advantage Payor that this applies to your billed services, you are subject to the notice and urged to apply for a Z-Code. This can apply to labs that do not reside in a MolDX MAC, such as Novitas.

If you have received notification from your Medicare Advantage Payor, it is important to register for a DEX Z-Codes to avoid potential loss of coverage.

3. Could the VALID Act Cause More Harm Than Good?

Lighthouse Lab Services President Jon Harol recently conducted an informal LinkedIn poll to gauge his audience's response on whether the VALID Act and the additional oversight it would require for LDTs would be beneficial for lab testing and patient access overall.

Out of 185 respondents, 56% responded that the act would be an overall negative and would stifle innovation, while 27% said LDTs do need additional oversight and 17% were unsure.

"While the VALID Act is well intended, no research evidence exists to prove FDA approval of LDTs will make them safer for patients," wrote one commentor.
VALID Act poll results
Deep Dive: Can Payors Recoup COVID Testing Claims During the PHE?
Ask Ann is a new revenue cycle management mailbag headed by Ann Lambrix, Vice President of RCM Consulting for Lighthouse Lab Services. Each month, Ann will be tackling the burning billing and reimbursement questions from our clinical laboratory and pathology clients.

In her first edition, Ann examines whether payors can recoup COVID testing payments during the COVID Public Health Emergency and offers some tips for how to proceed if you are selected for an audit.
Ann Lambrix
You can reply back to the payor reflecting any due diligence that you have done to vet patients up front. This may include any intake forms the patient is completing prior to testing, indicating any signs, symptoms, or recent exposure, and/or documentation from the ordering physician.

-- Ann Lambrix, Vice President, RCM Consulting, Lighthouse Lab Services

Interested in submitting a question for future mailbag consideration? Email Alex Mitchell, Communications Manager, at amitchell@vachettepathology.com.
1. The American Society for Clinical Laboratory Science Annual Meeting

June 26-30, 2022, in Grand Rapids, MI.

2. Florida Society of Pathologists Summer Conference

July 15-17, 2022, Breakers Palm Beach, FL.
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The Lab Insighter is a monthly publication for Lab Owners and Decision Makers.