June 2025
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Medicare clinical laboratory fee schedule (CLFS) rates for almost 800 tests are set to be cut by up to 15% on January 1, 2026.
A partial list of some of the largest cuts would be:
-15% for detect agent for NOS by PCR, lipid panels, Candida by PCR
-14% for comprehensive metabolic panel, DNA/RNA amplified probe
-11% for thyroid stim hormone, complete CBC w/auto diff wbc
In any case, you’ll want to ensure your claims are submitted for maximized reimbursement, and as cleanly as possible on first submissions while you proactively avoid denials.
ADSRCM for outsourced services and staffing helps our laboratory clients do that. If an in-laboratory platform is preferred, MedicsPremier from ADS can do the same on claims and denial prevention.
Click here for the CMS details on CLFS and here for the American Clinical Laboratory Association’s “take action” website, if you’re so inclined.
We hope you enjoy the rest of the read.
The June report to Congress is in. Some of its bullet points include:
Several of these involve laboratories; click here for the full details.
The Food and Drug Administration (FDA) published a request for comments in the Federal Register regarding their “Rare disease Innovation, Science, and Exploration (RISE) Workshop.”
To participate, you’ll need to submit a description of your proposed topic (of course), any suggested speakers/experts on the topic (of course), and other input such as any FDA guidelines that may already exist relative to your topic (if you know of any), developmental impacts, etc.
Click here for Federal Register details. Comments can be submitted electronically or by mail and are due by December 31, 2025. Hopefully you won’t be doing this on New Year’s Eve.
The U.S. Food and Drug Administration (FDA) has introduced Elsa, a new generative AI tool to aid FDA employees enabling them to access internal documents while ensuring all information remains within the agency.
Elsa doesn’t train itself on regulated data in order to safeguard sensitive research and data handled by FDA staff.
According to their announcement, the FDA “is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets,” and that that it (Elsa) can “summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications."
The owner of a Chicago-based laboratory was sentenced to seven years in a COVID-19 testing scheme. The scope of it was $14 million in claims for tests that were either never performed or not performed correctly, meaning the laboratory informed patients they tested negatively for COVID-19 even though tests were diluted by the laboratory owner to help reduce costs.
All of the details can be seen on the US Justice Department’s press release.
It may not have been in the headlines lately, but not only is bird flu still “a thing,” the first national proficiency testing program to help laboratories detect and accurately identify the H5N1 strain of bird flu will be delivered this fall according to CAP which developed the program.
Officially known as the H5N1 Influenza A Detection and Subtyping Program, it will be available to laboratories in November. In short, the program will allow laboratories test their ability to accurately detect and distinguish between H5N1 and seasonal flu strains.
How exactly will the program work? It will include two laboratory-created samples that simulate real patient specimens, allowing labs to verify their detection and subtyping processes under realistic conditions. How about that?
Two caveats, one of which is very time-sensitive:
There are two separate resources: click here to join the program, and here for CAP and more information on the program.
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July, with new articles and items of interest for laboratories!
With outsourced services from ADSRCM, you can maximize your laboratory's revenue and productivity. If you prefer in-laboratory automation, the MedicsPremier platform from ADS can be deployed! Contact us at 844-599-6881 or email rcminfo@adsc.com for more information, and about the ADSRCM guarantee to increase your revenue in 90 days.
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Marc E. Klar, Vice President, Marketing, ADSRCM.
Disclaimer: Articles and content about governmental information, such as CMS, Medicare, and Medicaid, are presented according to our best understanding. Please visit www.cms.gov if clarifications are needed. We are not responsible for typographical errors or changes that may have occurred after this newsletter was produced. Visit www.adsc.com to view our most up-to-date information. We don’t endorse any companies or organizations mentioned in our newsletters; you are encouraged to do research and due diligence on any that might interest you.
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Disclaimer: Articles and content about governmental information, such as CMS, Medicare, and Medicaid, are presented according to our best understanding. Please visit www.cms.gov if clarifications are needed. We are not responsible for typographical errors or changes that may have occurred after this newsletter was produced. We don’t endorse any companies or organizations mentioned in our newsletters; you are encouraged to do research and due diligence on any that might interest you.