Tuesday, March 10, 2015

What Mississippi, Telemedicine, and CVS have in common.

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In 2013, Mississippi passed a major telemedicine bill (see  here , here ).   A February 2015 article at Politico describes Missisippi as a l...
Monday, March 9, 2015

Flurry of Media on Competition versus Scale in US Healthcare

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I was asked to give a talk later this month on "how payers think," and one key concern of payers is consolidation of the providers...
Friday, March 6, 2015

FDA Announces Workshop on Companion Diagnostics Policy: March 24, 2015

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FDA has scheduled a public workshop entitled “Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Tar...

Two Online Articles on Payer Utilization Controls for Diagnostics

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The trade journals DARK DAILY and MANAGED CARE published two separate articles on rising utilization controls on diagnostic tests. The lin...
Thursday, March 5, 2015

Two Interesting Reports from Milken Institute: Innovation in Healthcare

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The Santa Monica-based Milken Institute released two interesting reports on healthcare innovation in the past year, one in March 2015 and on...
Wednesday, March 4, 2015

IOM hosted Precision Medicine Conference on April 1, 2015

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The Institute of Medicine will hold a public conference on precision medicine on April 1, 2015, under the title, "Policy Issues in the ...
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...