Wednesday, April 13, 2016

CMS Proposes Major Sanctions Against Theranos

On April 13, 2016, news broke that CMS had proposed major sanctions against Theranos, including a two year suspension.   The CMS letter to Theranos is 44 pages long and was written on March 18.

Some of the penalties are stated to take place "8 days" from the "date of notice of imposition" while others take place at 60 days.   CMS had given Theranos until March 28, 2016 to respond.  Major news article links are provided after the break.

April 13, 2016

"Theranos Founder Elizabeth Holmes is Facing a Ban by Regulators."
Fortune.  By Laura Lorenzetti.  Here.

"Theranos Under Fire as U.S. Threatens Crippling Sanctions."
New York Times.  By Reed Abelson & Andrew Pollack. Here.

"U.S. Government Wants to Ban THeranos' Elizabeth Holmes from Operating a Lab for Two Years."
The Verge.  By Arielle Duhaine-Ross.  Here.
Quote: "We are hopeful that CMS won’t impose sanctions," Theranos spokesperson Brooke Buchanan told The Verge in an emailed statement.

"Regulators Propose Banning  Theranos Founder Elizabeth Holmes For At Least Two Years."
Wall Street Journal. By John Carreyou and Christopher Weaver.  Here.
Several pages from CMS letter excerpted by WSJ, here.  Full 44p letter not released due to company's request for redactions. 
Quote: "The appeals process could take months, and such appeals have rarely succeeded in the past. A list of appeals decisions on the agency’s website shows that the agency didn’t lose a single such case from 2001 to the end of 2010. [here]"
(Note: Within 5 hours, WSJ had posted 255 comments.)

April 14, 2016

"CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan"
Dark Daily.  By Joseph Burns.  Here. 

For a deck about Theranos from my former mentor, Dr. Robert Boorstein, almost a year ago, May 2015, see here.

For additional links about Theranos: