Friday, February 27, 2015

AMA to Hill: Do Regulate MAAA Tests at FDA

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This article provides links to the AMA's February 2015 comments to the Hill, favoring tighter FDA regulation of "black box" al...
Monday, February 23, 2015

Why FDA's Go-Ahead for 23andMe is Significant

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On February 19, the FDA ( here ) and 23andMe ( here and here ) announced that the FDA has cleared a Bloom syndrome carrier screening geneti...
Monday, February 16, 2015

Your Quick Guide to Understanding the Weird 14 Day Rule (CMS Billing for Lab Tests)

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Note: There have been several updates after this 2015 blog, most notably, a 2018 rule, implemented in 1/2020, that outpatient genomic tests ...

Keeping up with AMP: Numerous Recent Policy Statements

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The Association for Molecular Pathology is elevating its position as a stakeholder group for molecular medicine even further with a rapid se...
Friday, February 13, 2015

If They Don't Like Your Service, CMS Can Suspend Your Enrollment!

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On December 5, 2014, CMS finalized a rule with the obscure title, "Medicare Program, Requirements for the Medicare Incentive Reward Pro...
Thursday, February 12, 2015

CMS Goes Live with New Oncology Payment Pilot Program

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What happened? New Oncology Payment System at CMS? On February 12, 2015, CMS released a request for applications for providers who can act...
Wednesday, February 11, 2015

NIH February 2015 Workshop on Precision Medicine, 1M Genomes

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On February 11-12, 2015, the NIH hosted a workshop on the "opportunities and challenges" of precision medicine, featuring a multid...
Monday, February 2, 2015

The Forgotten "Coverage with Evidence Development": HCFA and Heart Transplants

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"Coverage with Evidence Development" (CED) has received increasing attention since 2006, when CMS authorized the National Oncologi...

Commissioner Hamburg Says NGS Requires New Rules

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In a blog posted January 30, 2015, FDA Commissioner Hamburg states that next generation sequencing (NGS) testing may require new concepts an...
Sunday, February 1, 2015

Is the Learning Healthcare System Almost Suddenly Here? From ASCO and MolDX?

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2007:  We starting hearing the phrase "learning healthcare system," used as the title of an Institute of Medicine report ( here ) ...

Hear a Liz Mansfield FDA interview about regulating LDTs

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The website and podcast site MENDELSPOD (here) has released a 25 minute interview with Liz Mansfield, director of personalized medicine at t...
Saturday, January 31, 2015

New York Times Coverage of the Obama Precision Medicine Initiative

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In the State of the Union Speech on January 20, 2015, the President mentioned he would soon unveil an initiative in precision medicine.  The...
Friday, January 30, 2015

White House Details $215M Initiative in Precision Medicine

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In the President's State of the Union Speech , January 20, 2015, one sentence referred to a precision medicine initiative: 21st centur...
Wednesday, January 28, 2015

Metrics about MOLDX Code Coverage - A Snapshot for January 28, 2015

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Recently, I was asked to do an analysis of MolDX coverage by CPT code, and I pulled some of its current data into Excel spreadsheets, availa...
Tuesday, January 27, 2015

21st Century Cures: A Health Policy Legislation Smorgasbord

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Throughout 2014, the House Energy & Commerce special task force, "21st Century Cures," has held hearings on topics as diverse ...