Sunday, October 31, 2021

Very Brief Blog: AMA CPT Publishes Decisions from Sept 2021 Editorial Meeting

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The AMA CPT Editorial Panel meets three times a year, and a few weeks later publishes the results of the panel votes on new code proposals. ...
Thursday, October 28, 2021

Nothing Says Clickbait Like...

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Nothing says clickbait like a mummy in a cute hat -  Article .

Brief Blog; Novitas Finalizes PGx LCD; Tracks Close to MolDx

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MolDx and PGx Over a year ago, the MolDx MAC adopted a broad pharmacogenetics policy that keyed Medicare coverage to current FDA PGx recomm...
Wednesday, October 27, 2021

Very Brief Blog: Joe Grogan's Blog on the Need for MCIT

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Joe Grogan, one of the leaders in health policy for the Trump White House, is now a policy expert associated with USC and recently publishe...

PAIGE AI Webinar Shares More Data on Performance in Prostate Cancer Analysis

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PAIGE, developing AI software for pathology, received $100M in funding in early 2021 and FDA de novo clearance for prostate cancer AI in Sep...
Tuesday, October 26, 2021

Pew Charitable Trust Says More Regulation of LDTs Is Needed, "Growing Risk to Patients"

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In a fact sheet and a research report dated October 22, 2021, the Pew Charitable Trust argues that more federal oversight of LDTs is needed....
Monday, October 25, 2021

Tidbits: Webinar on Breakthrough Device Reimbursement; Roche Launches "Foundation Medicine in a Box" (RUO)

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Two items noticed in the Monday announcements. Webinar - There's a webinar on device reimbursement and FDA breakthrough status , Wednesd...
Thursday, October 21, 2021

Novitas Article Attacks Genetics Overspending; Action after "Operation Double Helix"?

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Novitas made some updates October 29, 2021, including "Clarifying 81479 text" - see most recent version here .  The minimal update...

Very Brief Blog: CMS Releases New Report on Innovation Center Plans

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There's a running joke that any given pharma is constantly restructuring one more time, and let's add, the CMS Innovation Center (CM...

MCIT Rule: 115 New October 2021 Comments! Zip File.

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  click to enlarge Most CMS rules go through one cycle of comments; the MCIT rule has gone through three , garnering  115 comments in the t...
Wednesday, October 20, 2021

Two Resources on Healthcare's Costly Administrative Burdens in the U.S.

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We constantly hear that U.S. healthcare has vastly higher administrative costs than anywhere else. ( Here , here .) Two new resources this w...
Tuesday, October 19, 2021

Very Brief Blog: Scott Gottlieb on Regulatory Policy for Devices; with Joe Grogan; at USC Schaeffer Center for Health Policy Oct 27

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On October 27, 2021, see a webinar with Scott Gottlieb discussing regulatory policy at FDA and lessons learned from the COVID epidemic.  He...
Friday, October 15, 2021

AMA Announces Review of 4th Quarter PLA Codes

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 AMA takes applications for new PLA codes quarterly, and the committee votes on them after a brief period for public comment.   The codes pr...

Medicare Coverage for Nephrosant "QSant" - First Urine-based Kidney Transplant Rejection Test

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The MolDx program has granted coverage to the NephroSant "QSant" urine-based test, a multi biomarker test including urine donor or...

Two Papers Highlight Amazing Speed of COVID Variant Replacement

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From October 4 to October 14, two remarkable papers on COVID sequence epidemiology and the remarkable speed with which one strain replaces a...