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 ...

Can OMHA do math? Do they want to?

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OMHA stands for the Office of Medicare Hearings and Appeals .   Generally, if you appeal a denied Medicare claim, seek reversal of an audit,...

The Vague Advisory Panel for New Clinical Lab Tests

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 Much attention has been aroused by the major reform of clinical lab test pricing in the Medicare system which occurred on April 1, 2014 (no...
Friday, March 7, 2014

Does the OIG's "Extend The DRG" report make no sense, or did I miss something?

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In February 2014, the OIG published a report whose whose title seems to clearly predict its content:  " Medicare and Beneficiaries Coul...

Is the FDA too slack or too tight?

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Is the FDA too lenient or too strict?  Controlling safety or stifling innovation? This question never goes away.   A few years ago ther...

Prior Authorization - Medicare - And the President's FY2015 Budget

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The 2015 Budget for HHS The President's FY2015 budget for the Department of Health & Human Services - including the FDA and Medica...