Monday, September 22, 2014

CDC Atlanta Forum on FDA LDT Regulation Announced: For November 4-5, 2014.

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The CDC has announced a three-agency forum on FDA LDT regulation, to be held in Atlanta November 4-5.  (FDA LDT regulation is only part of t...
Monday, September 8, 2014

House Energy & Commerce Holds Hearings on FDA LDT Proposal [September 9, 2014]

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On September 9, 2014, the House Energy & Commerce committee held a hearing through which a range of stakeholders could discuss the FDA...
Thursday, August 21, 2014

Two Publications: A New PMC Policy White Paper, and a New Paper on Clinical Utility

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This summer, I've been fortunate to have a hand in two publications.   I had a major writing role in the Personalized Medicine Coalition...
Monday, August 4, 2014

FDA RELEASES ITS PLAN TO ENTER THE DOMAIN OF LDT REGULATION

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On July 31, 2014, the FDA released an armful of documents announcing its extensive plans to regulate laboratory developed tests (LDTs)....
Monday, July 14, 2014

Government Responds to CCLA Lawsuit about LCDs; CCLA Responds to Gov't; Govt files its reply

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[Updated for all three July, 2014 documents] [Updated 8/27/2014:  Judges schedule oral argument for December.] [Updated 2/3/2015:  Oral...
Tuesday, June 24, 2014

Medicare MOLDX Program Posts Guidance Documents, New Coverage-With-Evidence LCD

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Since 2012, Medicare has supported a distinctive local contractor-based coverage and coding program called MOLDX.   The program was original...
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...