Monday, November 24, 2014

FDA announces two-day public LDT Regulation meeting, January 8-9, 2015.

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On November 24, 2014, the Federal Register published the FDA's announcement of a two-day public workshop on January 8-9, 2015, on its pr...

Medicare Finalizes an Updated "Coverage with Evidence Development" Guidance

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In 2006, Medicare released its first guidance document for Coverage with Evidence Development.  In 2012, CMS released a draft update of its ...
Saturday, November 15, 2014

Medicare MolDX Program Issues "Molecular Test Panel Alert"

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On Friday, November 14 , Medicare's program for molecular test coding, pricing, and coverage - MolDX - issued an "Alert" for m...
Wednesday, November 12, 2014

FDA Law Blog: Summary of November 6 CDC-FDA meeting on LDT regulation

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At the FDA Law Blog, Jamie K. Wolszon & Jeffrey N. Gibbs of Hyman Phelps provided an extended summary of the November 6 FDA-CDC public w...

CMS Releases Proposed NCD for Lung Cancer Screening

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On November 10, 2014, CMS released a proposed NCD that covers annual low-dose CT lung cancer screening for beneficiaries with a long smoking...
Monday, November 3, 2014

CMS Rulemaking for CY2015 Released: Outpatient and Physician Settings

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On Friday evening, October 31, CMS released its final policies and spreadsheets for CY2015 for both the physician fee schedule ( here ) and ...
Thursday, October 16, 2014

My Talk at Harvard

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On Friday, October 17, I had the opportunity to give a talk on genomic medicine policy in the U.S. at Harvard (Brigham & Women's Gen...
Thursday, October 9, 2014

CMS Releases Prices for New CPT CLFS Codes - Gene Panels Get Gapfill

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On October 9, 2014, CMS released its pricing decisions for all new CPT laboratory codes that will be active in 2015. It finalized its prop...
Thursday, October 2, 2014

FDA and LDT’s: Should it be "Guidance" or "Regulation"?

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Since a public meeting in 2010, the FDA has been discussing its plans to bring laboratory tests at local hospitals and laboratories under i...
Wednesday, October 1, 2014

A Critical Look at "Choosing Wisely" - But it's not Today's NEJM.

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Update 10/2017:   Health Affairs "festival" on Choosing Wisely held in DC, here .   Example of later quantitative health service...
Tuesday, September 30, 2014

FDA Releases Official Draft Guidance for LDTs; 120 Day Comment Period

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On September 30, 2014, the FDA officially released its two major guidance documents on LDT regulation: The first guidance covers a framework...
Friday, September 26, 2014

IOM Publishes Ebook: Characterizing the Uncertainty of Risks and Benefits.

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A fundamental problem shared by both regulatory agencies like the FDA and payers like CMS is assessing the level of net benefit for a new p...
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...