CMS has posted a five hour video of its Annual Lab Meeting [for pricing new lab codes], held June 27, 2025.
Let me walk you quickly through the maze.
Go to the CMS annual lab meeting page:
Scroll down to Meeting Notice & Agenda & Other Important Materials
Click on that.
Look for "CLFS Annual Public Meeting Recording, June 27 2025".
That's a link. It will take you to a Zoom archive page where you will enter the password CMS provided next to its link above.
This brings you to a 3-hour video. When it finishes, it automatically rolls into a second, 2-hour video, giving you the whole day with 50 presentations for 100 codes.
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AI CORNER
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For me, in CMS video 2, I could harvest 14,000 words of autotranscript (40pp). However, I failed to successfully harvest the autotranscript CMS Video 1.
Therefore, for the morning, I used an autotranscript of an audio capture that I made in real time. However, my own morning audio had some gaps due to laptop freezing.
Taking what I had for morning, and CMS's posting for afternoon, gave me a 67-page autotranscript, the morning from my audio with gaps, the afternoon, direct from the CMS archive website.
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By [Author Name]
July 7, 2025
Baltimore, MD — At the annual CMS Clinical Laboratory Fee Schedule (CLFS) public meeting on June 27, the stage was set for one of the most consequential ritual gatherings in the clinical lab calendar. This year’s edition featured over 50 presentations and more than 100 new and revised lab codes, as diagnostic companies and lab industry representatives delivered their appeals to CMS pricing staff in the hopes of shaping the reimbursement landscape for 2026 and beyond.
The Format: Fast-Paced but Deeply Technical
The day was divided into two main sections: presentations by lab industry representatives proposing crosswalk or gapfill pricing strategies for individual codes, and intermittently, CMS staff commentary, often succinct and procedural. While each speaker was given just minutes to make their case, many presentations included deeply technical rationales, ranging from bioinformatics workflows to analyte counts, and from proprietary algorithms to labor-intense pre-analytic processes. As one attendee noted, “This is not a meeting for the faint of heart—or for those unfamiliar with the difference between cfDNA and mRNA workflows.”
Themes and Trends: NGS, MRD, and AI
Three major trends defined the presentations this year:
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The Rise of Minimal Residual Disease (MRD) Testing: Several companies pitched MRD assays—both tumor-informed and tumor-naïve—highlighting their ability to detect ctDNA with increasing sensitivity. While most recommended crosswalks to existing MRD CPT codes (like 0306U or 0493U), others requested gapfill, citing novel features like methylation-based signatures or tumor-naïve algorithms.
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Expansion of AI and Multi-Analyte Panels: From blood-based Alzheimer's detection to early rheumatoid arthritis identification, a notable share of presentations described algorithm-driven diagnostic tests incorporating anywhere from 3 to 30 biomarkers. Speakers frequently emphasized the complexity and clinical value of proprietary scoring systems, with crosswalks requested to codes that similarly blend laboratory data with machine learning outputs.
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Multiplex Testing and Resistance Genes: A significant number of presenters described multiplexed infectious disease panels, including expanded UTI, STI, and respiratory panels—many boasting over 20 analytes or the inclusion of resistance genes. There was clear pushback against one-size-fits-all pricing, with multiple speakers calling for recognition of the increased reagent costs, instrumentation needs, and technologist labor.
Crosswalk vs. Gapfill: The Central Debate
At the heart of most presentations was the fundamental binary of crosswalk vs. gapfill. While many sponsors proposed crosswalks to existing codes (with or without modifiers like 1.15x), others argued that their tests were truly novel and required gapfill pricing—where CMS defers pricing decisions to MAC contractors, often creating unpredictability but a chance for fairer valuation.
Some presenters gamely offered multiple fallback options. Others bristled at CMS’s past precedent of assigning low-paying crosswalks to high-complexity tests. Several emphasized that even seemingly similar tests differ in sample types (e.g., plasma vs. whole blood), analyte counts, or the burden of algorithm validation and report generation.
Stakeholder Frustrations Surface
While the day proceeded in orderly fashion, hints of stakeholder fatigue emerged. A few presenters questioned the logic of prior CMS pricing decisions, and some highlighted that tests cleared by FDA De Novo pathways or covered by Medicare already were still being subjected to low crosswalk assignments.
In one exchange, a presenter for a new Alzheimer’s biomarker test asked rhetorically, “If CMS believes in early detection, and we can do it with a single tube of blood, shouldn’t that be recognized with a modern reimbursement level—not one borrowed from a two-biomarker ELISA?”
CMS Panel: Observing, Not Responding
CMS staff maintained their long-standing policy of non-engagement during public comments. While they introduced each speaker, thanked them politely, and noted time limits, there was no dialog or real-time feedback. However, panelists did occasionally request clarification, particularly on proposed crosswalks or sample processing requirements.
The Bottom Line: A High-Stakes Ritual
For lab industry insiders, the CMS Annual Lab Meeting is a ritual of equal parts hope, persuasion, and precedent. While reimbursement decisions won’t be announced until late fall, companies know that what happens in this one-day hearing can define the fate of a new diagnostic for years.
As a senior market access executive quipped during a hallway break, “It’s our Super Bowl—just with more ELISA slides.”
Sidebar: What is Crosswalk vs. Gapfill?
Crosswalk: CMS assigns a payment rate based on an existing, similar code.
Gapfill: CMS asks MACs (Medicare contractors) to determine payment based on cost, resources, and other factors. Often slower and more variable.
Any moments of humor?
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Yes — even in a high-stakes, detail-heavy meeting like the CMS Annual Lab Meeting, moments of dry or unintended humor did emerge. Here are a few you might consider referencing or quoting if you want to inject levity into your article:
🧪 Moments of Humor and Humanity from the CMS Lab Pricing Marathon
1. "Applause" after presenting a melanoma test.
After a particularly dense presentation about sentinel node prediction using PCR algorithms, the transcript simply notes:
Unknown Speaker 16:37 — “Thank you. Applause.”
It’s unclear whether there was real clapping, or whether the transcriber was being a bit hopeful — but after three dozen slides on FFPE blocks and gene expression normalization, one can sympathize with the impulse.
2. [refers to my AM transcript gap due to freezing.].
3. A Sudden Reference to ‘Breast Milk Thickness’
In a melanoma test presentation, the speaker described the Merlin test’s algorithm as incorporating clinical factors like patient age and the auto transcript comes out as, “breast milk thickness of the tumor.”
Clearly a blooper for “Breslow thickness,” but in the context of cutaneous melanoma, the slip was both jarring and weirdly endearing. One imagines CMS analysts perking up mid-scroll with, “Wait—what did he just say?”
4. [Skip]
5. “Stop me if you’ve heard this before…”
Mike Ryan of McDermott Will & Emery, representing the Point of Care Testing Association, opened one of his final code rationales with:
“Stop me if you’ve heard this before…”
He was on his ninth test recommendation of the morning. Many had heard it before. No one stopped him.
6. Not Quite 'AI Will Replace Pathologists' — But Close
Several presenters detailed AI-driven diagnostic algorithms in tones of hushed reverence. One could almost imagine the subtext:
“No, we don’t need your pathologist’s eyes anymore — we have a logistic regression model trained on 7,000 validated samples with a 93.8% area under the curve.”
7. A Dry Punchline in the Midst of Biomarker Chaos
During a very earnest description of a test for inflammatory bowel syndrome, the speaker concluded:
“We think 18 antibody measurements is more work than 2. So, if you like the 2-antibody test, maybe double it for us.”
It was a rare moment of pricing logic presented with a wink.
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Highlight 5 surprises.
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Here are five surprising moments from the 2025 CMS Annual Lab Meeting transcript — standouts that even seasoned attendees might not have seen coming:
🔍 Five Surprises from the 2025 CMS Lab Meeting
1. The Rise of Alzheimer’s Blood Tests — Now a PLA Code Contender
Lucent Diagnostics presented a multi-analyte blood test for Alzheimer’s disease (0568U) using five biomarkers, including phosphorylated tau and amyloid-beta.
Why it's surprising: Blood-based Alzheimer’s tests were speculative only a few years ago. Now, a vendor is seeking a formal crosswalk with clear clinical utility and eligibility implications for monoclonal antibody therapies. It signals just how fast neurodegenerative diagnostics are transitioning into real-world practice.
2. IBS Gets the Immunoassay Treatment — With a GI Journal Backing
Ethos BioAmerica pitched a food-sensitivity test for IBS (X186U), based on IgG response to 18 foods, describing it as a guide for dietary elimination therapy.
Why it's surprising: Food-based antibody panels are often dismissed as unscientific or “alternative” by mainstream GI clinicians. Yet this test was studied with Mayo Clinic and published in Gastroenterology — a credential that might shift how CMS and payors view the category.
3. A Three-Platform Cyst Fluid Test — With Raman Spectroscopy
Amplified Sciences introduced a test for classifying pancreatic cysts (0573U) using three different instruments across three analytes, including glucose and CA markers — and notably, Raman spectroscopy for gastricsin.
Why it's surprising: Raman spectroscopy is rarely seen outside of research labs or pharma QC, let alone priced by CMS. The test also runs sequentially on three different platforms — not a model of automation, but a case study in niche precision medicine.
4. A Transplant Test That Doesn’t Use the Tumor
Guardant’s MRD test (0569U) seeks residual cancer without tumor-informed design, instead relying on methylation signatures across 13,000 genes.
Why it's surprising: Tumor-naïve MRD was once seen as aspirational. Now a major player like Guardant is presenting it to CMS as a ready-for-prime-time option, with clinical validation in colorectal and breast cancer already in print.
5. A Point-of-Care TBI Test for CT Avoidance
Abbott presented the i-STAT TBI test (0470U), which measures GFAP and UCH-L1 proteins from whole blood or plasma and helps determine whether patients with suspected traumatic brain injury need a CT scan.
Why it's surprising: It’s a point-of-care, semi-quantitative neuro test that could potentially alter ED triage and imaging decisions — a rare example of CMS being asked to price a POC diagnostic that could replace imaging rather than supplement it.
Chat GPT reported that 12 presentations of 50 had substantial comments or Q&A it could identify. I can't verify that.
