Saturday, May 31, 2014

Judges Reject Decades-Old Medicare Ban on Transgender Surgery

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On May 30 and 31st, the media buzzed with reports that judges at Medicare had suddenly thrown out the longstanding federal ban on payment f...
Tuesday, May 20, 2014

Using the Giant Medicare Physician Data Database

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In April 2014, after years of legal efforts by multiple parties, including the Wall Street Journal, CMS released nearly 2 GB and some 10 mil...
Tuesday, May 6, 2014

An Online Video Course on Clarifying Discussions of Clinical Utility

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This course summarizes PowerPoint seminars I've given in the first half of 2014 at several conferences and workshops.   Our peer-reviewe...

Wednesday May 14: Washington Panel on Lab Markets after PAMA

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PAMA is the acronym for the bundle of changes to Medicare policy that become law on April 1, 2014.  Most prominently, it deferred the physic...
Saturday, May 3, 2014

Lung Cancer Screening: CMS Advisory Panels Splits 180 degrees from USPSTF

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Update: Proposed CMS Decision released, November 10, 2014:  See here . ___________________ Last winter, the United States Public Services...
Friday, April 25, 2014

Book review and comment: The Remedy (Robert Koch, Arthur Conan Doyle, and Pasteur)

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The Remedy , by Thomas Goetz.   An offbeat view of history that brings together Robert Koch, Conan Doyle, Pasteur, and the quest to understa...

California Clinical Lab Association Protests CMS Authority for LCDs

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The California Clinical Laboratory Association (CCLA) has filed a lawsuit in federal court in Washington, DC, challenging authority of CMS t...
Tuesday, April 22, 2014

FDA Announces Another Workshop on Next-Gen Sequencing - September 24-25, 2014

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The FDA has just announced another workshop on policy for next-generation sequencing.  (See the meeting announcement here .)  According to t...
Monday, April 21, 2014

April Medicare Reform and the Tangent that Impacts Pathology Tests

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April's Medicare bill, most simply described as "The 2014 SGR Bill," is formally named the Protecting Access to Medicare Act o...
Thursday, April 17, 2014

Structured Risk Benefit and the Elucidation of Uncertainty

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The Long Struggle to Clarity on Risk/Benefit Decisions The FDA and international regulators have long struggled with how to assess risk/be...

23andMe is Alive and Well in the Media This Spring

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In a well known story, the Yahoo-backed direct-to-consumer genetics company 23andMe was on a roll last fall - capped with the appearance of...
Wednesday, April 16, 2014

FDASIA Report on Healthcare Software Regulation Released - April 2014

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"FDASIA" was the 2013 round of new funding for the FDA.   One of its mandates was the the FDA collaborate in a multi-stakeholder e...

An Important New Blog has Appeared!

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There are a lot of good blogs available...I track a couple dozen, and least lightly, via the web app FEEDLY , have a few real favorites, and...

Are Health Technology Assessments Good or Evil or is this the Wrong Question?

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Often the perspective from industry on health technology assessments is that they are more-or-less evil (on a scale of good to evil).   I wa...

The Go-To Article on Everything that's been Written on Clinical Utility

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In the past decade, much has been written about how to define, assess, or benchmark the clinical utility of clinical laboratory tests, like ...