Wednesday, November 15, 2023

House Passes Delay of PAMA

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In its brand new budget proprosal, to keep the government open til early 2024, the House passes a full one-year delay of PAMA. The math is a...
Monday, November 13, 2023

Using AI in Real Life: GPT4 Assesses FDA's "BENEFITS" of LDT Proposal

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Can you use AI in real life?   Here's an example where AI can act as a "second reader" and help you cross-check your opinions,...

A Quote for Your FDA LDT Comments: Shuren Says "We have to change federal law" to fit today's innovations

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Right now, countless groups are working on comments to submit by December 4, 2023, on the FDA's haywire proposal to regulate LDTs.  I sa...
Sunday, November 12, 2023

Podcast Watch: History and Issues for Genomics Coding (Jim Almas, Perry Dimas, "Promise of Personalized Medicine"

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In the podcast realm, one new episode of particular interest is, "Deciphering the Code: The Complex World of Genetic Test Coding."...
Friday, November 10, 2023

Decibio: Excellent Hour Webinar on Oncology Reimbursement in Europe

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This blogs connects you to an excellent multi-expert one hour webinar on reimbursement in Europe, offered last month by Mansfield Advisors a...

A Lawyer's View: Potential Weakness of FDA Regulation of LDTs (Stacy Amin, Morrison Foerster)

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See an excellent new five page analysis of potential weaknesses in FDA's arguments for its LDT regulating authority.  By Stacy Amin, for...
Thursday, November 9, 2023

AI Corner: Wow, Now, Direct Upload of Science PDFs into ChatGPT 4

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All year, I've been using Chat GPT4 to summarize things.   Problem was, it was limited to about 2000 words at a go.  (There are " s...

CMS Gives NCD-level coverage to Tempus FDA test; Uses 81479 not 81455

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CMS closely describes MAC claims handling for tests under NCD 90.2, NGS tests for cancer patients.  They have newly added coverage of the TE...

Trade Journal Watch: 360DX Covers CMS Underpricing of New Cancer GSP Codes

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 On October 30, I wrote a blog that AMA CPT had added a long series of new comprehensive genomic profiling (CGP) codes for 2024,and that CMS...
Sunday, November 5, 2023

Brief Blog: NEJM Op Ed Supports FDA Control of LDTs

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A new Op Ed by Singhal et al - from Ann Arbor, Mayo, and Harvard - strongly supports FDA regulation of LDTs.   NEJM pieces like this carry a...
Thursday, November 2, 2023

Very Brief Blog: CMS Posts OPPS, PFS Annual Rules for CY2024

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 CMS posted annual final rules for PFS and OPPS on the evening of November 2, 2023.  As usually, CMS posts "typescript" versions a...

Brief Blog: MEDPAC discusses Software & CMS Payment Policy

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On November 2, 2023, MEDPAC , the official body advising on Medicare policy, held a one-hour discussion of CMS policy and payment for softwa...
Wednesday, November 1, 2023

Brief Blog: DECIBIO Survey on FDA LDT Regulations

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An excellent, 12-page survey from DECIBIO on how the lab industry is viewing the proposals for FDA LDT regulation. Find it here: https://www...

It's Crazy But It's True: Novitas Oncology Public Meeting Vanishes from Website

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This past summer, the Novitas MAC had a stormy battle with lab stakeholders over a newly restrictive LCD for oncology biomarkers.  One featu...

Journal Club: The Economist: Have Healthcare Costs Stopped Rising (as Share of GDP)

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Normally, I would only cite an open access article as "journal club" (and in fact you might get a couple free articles a month fro...