Wednesday, June 18, 2025

Medicare Has an NCD about Gender Dysphoria Surgery (Local MACs)

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Medicare allows gender-changing surgery specifically at MAC discretion, based on a 2014-2016 legal case.    ## We hear a lot in 2025 about g...
Tuesday, June 17, 2025

RNA DNA - Transcriptome and Genome in Tumors - Yudina et al. (BostonGene)

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We've just had news that Natera can transition Medicare patients to a  genome-based MRD test .  And we've got Caris doing an IPO as ...
Sunday, June 15, 2025

WSJ: How Scientific Journals Became Latest Target

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 On June 13, 2025, WSJ reviews adminstrative actions regarding medical journals and whether they show "political bias, corporate influe...

MedPAC to Congress: June 2025 Report on Medicare

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 On June 12, 2025, MEDPAC released its 2025 Report to Congress on the Medicare program. Find the webpage here and the 419-page PDF report h...

White House Releases Details: CMS Budget Cuts

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HHS states that MACs will still be able to perform all their duties despite decreased funding because the budget “reflects efficiencies gain...
Thursday, June 12, 2025

MolDx Releases Two Cardiac Genetic LCDs - Final LCDs

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MolDx releases two cardiac genetic LCDs , requested by Invitae in about February 2023 (about 2.5 years ago).   Both were issued as draft LC...
Wednesday, June 11, 2025

Joe Grogan in WSJ: Time to Pull the Plug on "CED" in NCDs

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Health policy expert Joe Grogan , of USC's Schaeffer Institute, pens an Op Ed in the WSJ today, arguing that it is time to pull the plug...
Tuesday, June 10, 2025

Caris Files for IPO at $5B: Documentation Links; Key Quotations and Metrics

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Caris Life Sciences has filed for an IPO, with a planned value of $424M, at a valuation per share of $16-18.  According to one summary, this...

New June 10: Makary and Prasad on "Priorities for a New FDA"

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 A few days ago I highlighted a new paper by Vinay Prasad on "surrogate endpoints" - here . Today, June 10, Markary and Prasad pub...

Novitas MAC Updates LCD for "Gender/Sex"

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The Novitas MAC has updated its oncology LCD to account for administration requirements regarding use of gender and sex. Here's the Apri...
Monday, June 9, 2025

Some New Papers: Fojo, Bates on Interpreting Clinical Trials. FDA's Prasad on Surrogate Endpoints.

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 A flurry of interesting articles in the last few days. Fojo and Bates on Interpretation At JAMA Oncology, Fojo and Bates write a 3-page sho...
Monday, June 2, 2025

Hogan Lovells Posts Summary: AI and Reimbursement Today and Tomorrow

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 Recently, Hogan Lovells held a workshop on cutting edge issues in reimbursement, including AI.   Luckily, they've posted a detailed sum...
Sunday, June 1, 2025

ACLA POSTS: LDT RULE is DEAD

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 According to ACLA, the HHS has let pass its 60-day deadline to lodge notice-of-appeal regarding the FDA LDT Rule.  The Notice of Appeal wou...
Saturday, May 31, 2025

The MAHA Report --> AI Used Dumbly

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By now, you've probably heard that the May 22 version of the Make America Healthy Again report had many errors due to AI-created false c...