Wednesday, December 17, 2025

A Little More About WISeR: Medicare's Rapidly-Arriving Pre-Authorization by AI

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  WISeR   is the recently-announced, rapidly-arriving demo program for AI-Prior Auth in Medicare Part B. None of the target services are lab...

Rakha et al. 2026: New International Consensus Criteria for HER2 Low & Ultralow

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For several years, there's been steady news about using drugs or combinations in ultra-low Her2 categories.   See a new concensus articl...
Tuesday, December 16, 2025

MolDx on the Podcast Circuit: Gabriel Bien-Willner @ DIASORIN

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The DIASORIN Podcast, "Beyond the Result," brings us an interview with Dr Gabriel Bien-Willner.  It's titled, "The Payer ...

MedPAC 2024: How Medicare Thinks About AI Reimbursement

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We have more and more emphasis in genomics on AI and bioinformatics, so the way CMS thinks about software is relevant. A current article by...

From ESMO: Requirements for AI-based Biomarkers in Oncology

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 At Linked In, Josie Hayes flagged an important consensus new article from European Society of Medical Oncology.   Her note is here .   Hay...

Pierre Arsene: LBX Stocks Raise $50B in Market Cap This Year

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I haven't tried to replicate the math, but at Linked In, Pierre Arsene repors that liquid biopsy stocks generated $50B in market cap thi...
Sunday, December 14, 2025

Unprecedented; SENATE Wants to Hear Your Coding - Innovation Problems

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Update.  Senator Cassidy has exchanged letters (and press releases) with the AMA on a number of coding topics, RUC, CPT membership, etc.  I ...
Saturday, December 13, 2025

Scott Gottlieb in JAMA: AI Can Solve Productivity Challenges

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 I enjoyed this article alot, and it's very germane to current hot topics at CMS (and AMA).   Here's an AI picture, an AI summary, a...

What the Hell is MAHA ELEVATE?

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You've tried to at least recognize what the new programs ACCESS and TEMPO mean (at CMS and FDA, respectively, but they interact...) Her...

Will FDA and Other Digital Pathology Advances Outrun AMA CPT Rules in 2026?

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Header:  AMA CPT may soon face a crossroads for modernizing coding of digital pathology. ## Update:  The U.S. Senate wants to hear your con...
Friday, December 12, 2025

CMS, FDA: Keeping Up with TEMPO and ACCESS

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"Last week, CMS and the FDA announced coordinated efforts to widen access to technology-enabled care for Medicare beneficiaries with ce...

Republican Health leader Joe Grogan Interviews Deputy Secretary of HHS on AI

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There's been a flurry of AI-related news this week, including in healthcare.  See a December 12, 2025, article at Fierce Healthcare whe...
Sunday, December 7, 2025

Humor: Medicare Non-Coverage of Stethoscopes, Microscopes, and X-Rays

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I was somewhat annoyed by a new LCD announcing broad Medicare non-coveage of AI in imaging. ( Here ).  I asked Chat GPT to review Medicare c...

CMS Expert Becomes Deputy Director of CBER at FDA

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Many of us who've worked for some time in genomics will remember Katherine Szarama PhD , who was one of the CMS coverage group staff ass...

MAC Issues LCD on Automated Detection of Brain MRI's: NO COVERAGE

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 The CGS MAC has issued a final LCD on "Automated Detection and Quantification of Brain MRI's", L40224.   The proposal appeare...