Thursday, November 21, 2024

A Medicare Nerd Note: When Are NCD's Effective?

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Here's a small Medicare policy mystery.   I've always said that NCD's are effective on the date published , and I recalled that...
Wednesday, November 20, 2024

CAP to Trump Transition: Dump FDA LDT Regulation

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College of American Pathologists has sent two letters, one to Congress and one to the Trump Transition team, asking that the FDA regulation ...

Politico Names Contenders for HHS Jobs; Vinay Prasad of UCSF

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In an open-access article, Politico discusses potential contenders for a range of HHS positions, like surgeon general and head of NIH.    Pr...
Tuesday, November 19, 2024

FDA Discusses Gen-AI in Dig Health Advisory Committee (November 20-21, 2024)

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FDA will convene its Digital Health Advisory Committee to discuss Gen-AI in a two-day workshop, Wednesday-Thursday, November 20-21, 2024. Th...
Monday, November 18, 2024

Medicare Fraud; Trump Office of Government Efficiency; Expert at Boston University

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There's much press about the proposed Department of Government Efficiency - DOGE - to be headed by Elon Musk and Vivek Ramaswamy (The H...
Sunday, November 17, 2024

Two New Articles, FDA Authors, Nuanced Cancer Policy Challenges (Fallah 2024, Mehta 2024)

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Thanks to Nicholas Sarlis MD PhD at Linked In for highlighting two new oncology policy articles by FDA authors, in J Clin Oncol. Mehta &...
Thursday, November 14, 2024

RFK Announced for New HHS Secretary

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On November 14, 2024, the incoming Trump administration announced that Robert F. Kennedy Jr would be nominated for Secretary of Health and H...

AI Regulation From HHS Not FDA: Section 1557 of Affordable Care Act

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 When we hear about AI regulation, it's usually a discussion of the FDA.   However, Section 1557 of the Affordable Care Act effectively ...

Robert Califf's Discussion of FDA at Friends of Cancer Research

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This week, Friends of Cancer Research held its annual meeting , with a keynote address by outgoing Dr Robert Califf, commissioner of the FDA...
Wednesday, November 13, 2024

Major Article on Tumor Genomics and Pathologist-Directed Workflow (Dowdell 2024)

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Back in May 2024, I wrote a blog about a remarkable new article from MolDx discussing, "When Pathologists Can Order Molecular Tests.&qu...

A Plethora of Meetings: (1) PMC, (2) FOCR, (3) Milken Institute, (4) AMP, (5) G2

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A plethora of annual meetings right now. PERSONALIZED MEDICINE COALITION November 13-14, 2024, in Boston.  Primarily in person. Here's t...
Sunday, November 10, 2024

Now Streaming: CAP Webinar on How FDA Defines Risk (w/ Tim Stenzl MD)

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CAP is running a series of major webinars on how FDA regulates laboratory-developed tests.   They remark the series is intended to follow, m...