Sunday, September 13, 2026

Genomeweb: Alarm Over CMS Rule on Lab Algorithms

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  See a subscription article at Genomeweb about "algorithm only testts." By Adam Bonislawski, 9/11/26, here: https://www.genomeweb...

Do Current Fraud Press Releases Flag the Pending CRUSH Regulation?

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 Last winter, CMS introduced the CRUSH anti-fraud program, with an RFI in the Federal Register.  Since August 2026, that has matured to a pr...

The Evergreen HHS Press Release: Recyling Rural Health Investment News

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Header: In July 2025, Congress passed a huge tax bill that included $billions in spending for rural health, especially rural health technolo...
Thursday, September 10, 2026

AMA CPT Asks Weird Social Equity Questions; RFK Jr Goes on Attack

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It's no secret that AMA CPT applications are full of now-sounds-dated language about whether an applicant's CPT code " perpetua...
Wednesday, September 9, 2026

You Better Learn the Biggest Myth About Payor Coverage of Diagnostics

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  "The Coverage Myth in Diagnostics" In an interview, I was asked, "What's the biggest myth you hear repeated?'   Tha...

AI Corner: The strange path to remote monitoring coding, and the latest twist

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 Somone asked me about the "complexified" coding of remote monitoring, a current hot topic at CMS. I'm not a native expert, so...
Monday, September 7, 2026

AI Guest Author: A New Report on Better External Control Arms via N-Power Medicine Series B

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  I saw a headline that N-Power Medicine , which promises new ways to do oncology trials, had raised $32M by large investors, including La...
Sunday, September 6, 2026

Humor: From Cocktail Napkin Scribble to Sophisticated Diagram

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Last week, I published a white paper arguing that the "transformation event" in digital pathology will be when  AI can read slides...

AMA Lab Code Application Revisions are Large and Important

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Header: Tab 94 for the next AMA CPT Editorial Meeting proposes massive revisions to the code change application (CCA) for laboratory/pathol...

AMA's Appendix S: Don't Incorporate Into Code Decisions Until it is Fixed

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Header:   As we prepare for the September AMA CPT meeting in Minneapolis, one proposal brings new "Appendix S" strongly into the C...
Thursday, September 3, 2026

Humor: Sorry We Have No Design Suggestions

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Sorry, We have No Design Suggestions For This Slide. (click to enlarge)

FDA is Really Doing It: Downclassify CDx based on ISH-FISH (August 2026)

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  FDA Quietly Moves Oncology ISH/FISH Companion Diagnostics From PMA to 510(k) A Biden-era deregulatory promise survives the LDT court loss ...

MolDx Issues Bonanza of New LCDs in Late August 2026

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 MolDx issues a bonanza - a triplet - of new proposed LCDs. Two provide defined coverage.  One general NGS LCD for heme malignancies,  one f...
Wednesday, September 2, 2026

MolDX MACs Delay Finalization of Prelude DCISion-RT LCD

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MolDx released a draft non coverage LCD for the DCISion-RT test last year, and it's not finalized yet. It may be a while: they've an...