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...
Friday, May 30, 2025

CMS Publishes Updated Code List for Summer Lab Pricing Meetings

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For the summer Annual Lab Meeting, CMS has published an expanded code list, with 91 action items.    Go to this site and scroll down for Mee...

(From Endpoints): Illumina's Diaspora, Customers and Competitors

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The interesting news site Endpoints News has an article on Illumina and the sequencing ecosystem, by editor Jared Whitlock.   Find it here: ...
Thursday, May 29, 2025

AdvaMed Says: CMS, FDA Leadership Care About Breakthrough Device Coverage

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AdvaMed has a new posting on Linked In, highlighting a recent panel in which HHS leadership voiced a commitment to Breakthrough Device cov...

NEJM Covers the FDA LDT Legal Decision

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It's about 60 days since a Texas federal court tossed out the FDA LDT regulation.   Recall the government had 60 days to file an appeal....
Tuesday, May 27, 2025

CMS 2023 Lab Data Part B - HIghest Dollar Volume Codes

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  In a previous blog , I noted that CMS had released CY2023 Part B claims (by doctor or by lab) for CY2023.   I showed the top ten billing l...