Tuesday, January 8, 2019

Very Brief Blog: The Startup Health Festival in SF, Adjacent to JP Morgan

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This morning I was having breakfast at 7 am adjacent to my SF office and I noticed banners for a "Startup Health Festival" - one ...
Monday, January 7, 2019

Very Brief Blog: FDA Releases Self-Certification "Working Model" For Digital Health

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On January 7, 2019, FDA released a position statement from Commissioner Dr Scott Gottlieb, as well as a raft of links to new webpages and do...
Sunday, January 6, 2019

Could CMS Open NCD on Genesight? Coding Implications.

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In a major advance, last week Myriad Genetics announced the publication of its GUIDED clinical trial of the impact of psychiatric pharmacoge...
Friday, January 4, 2019

Very Brief Blog: AMP Asks CMS Reconsider BRCA Pricing in 2019

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Genomeweb reports today that AMP has asked CMS to reconsider the pricing of new BRCA codes established through the 2018 summer comment and ...

Very Brief Blog: Two Big Digital Genomics, Digital Pathology Investments

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Two news items on digital laboratory medicine - $68M for Digital Pathology in UK The December 24, 2018 Dark Report (subscription, but yo...

Brief Blog: CMS Extends Lab Date of Service Rule, Again, to July 2019

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On December 26, 2018, CMS released an announcement that it was again delaying required implementation of new Date of Service rules that had ...
Thursday, January 3, 2019

Pittsburgh Authors Publish Review of National CMS SEP-1 Data

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I have previously published two articles on CMS SEP-1 performance data, one in August when 3-quarter 2017 data was first released ( here ) a...
Wednesday, January 2, 2019

Has Medicare Canceled Much of Germline BRCA Testing, Including for Ashkenazi Populations? New 2019 MolDx LCD

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Today I was scanning 2019 LCDs for updates and found an unusual one in the MolDx program. Search the Medicare Coverage Database for the BR...
Thursday, December 27, 2018

Medicare Toughens Rule on Panel Coding; Effective January 1, 2019

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This post correct an erroneous, deleted post from yesterday December 26. November:  Weirdly Complex Rules for Genetic Test Coding for Janu...
Wednesday, December 26, 2018

(Weblink for post in error)

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On Dec 26-27, this link held an erroneous post that CMS had deleted some unusual coding rules for genetic testing, rules that were released ...
Sunday, December 23, 2018

Very Very Brief Blog: Medicare Approves a Second ADLT Lab Test (Biodesix "Veristrat" test)

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Takeaway:  CMS has endorsed the Biodesix Veristrat test, 81358, as an ADLT, so it will get annual pricing.  The only prior ADLT was FMI F1 C...
Tuesday, December 18, 2018

Very Brief Blog: Nerd's Update on AMA PLA Codes at CMS

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PLA-ology As We Enter 2019 Section 216 of the Protecting Access to Medicare Act of 2013 revamped the Clinical Lab Fee Schedule, setting i...
Monday, December 17, 2018

Very Brief Blog: FDA Hires Roche's Amy Abernethy For Deputy Commissioner

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FDA has hired former Duke academic and medical industry executive Amy Abernethy MD as Deputy Commissioner. Abernethy, once known for her ...

Very Brief Blog: CMS Releases CY2019 Full Lab Fee Schedule

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On Friday, December 14, CMS releasd the full CLFS fee schedule for CY2019.  There aren't surprises; CMS is implemented PAMA cuts relea...
Saturday, December 15, 2018

Obamacare "Struck Down;" Read Ruling Here; Judge Nixes CMMI and Biosimilars, Too

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Update.     January 2, 2019, article in SLATE reviews interim events and opinions, here .  Link to 30 page ruling by Judge O'Connor ...