News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Theranos Loses Its Biggest Revenue Source as Walgreens Ends Partnership and Shuts Down Blood-Collections for Clinical Laboratory Tests

The decision means Walgreens will no longer offer Theranos blood-collection services at any of its stores, a move that is expected to cut Theranos’ income sharply because the lab testing company would no longer have a significant source of medical laboratory test volume

Walgreens Boots Alliance (NASDAQ:WBA) is ending its relationship with Theranos Inc. and closing all 40 Theranos Wellness Centers at its stores in Arizona, effective immediately, the national pharmacy chain store company announced on Sunday, June 12. It means that Theranos will no longer be able to collect medical laboratory specimens at pharmacies owned by Walgreens.

This move follows a decision by Walgreens in January that Theranos could no longer send clinical laboratory tests collected at Walgreen’s Wellness Centers to the Theranos lab in Newark, Calif. In the fall, the federal Centers for Medicare and Medicaid Services (CMS) cited the Newark lab as the source of serious deficiencies that risked patient harm, CMS said. (See Dark Daily, “CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan,” April 14, 2016.) (more…)

CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan

Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal

Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.

In a letter to Theranos executives, CMS said it is prepared to:

• revoke the company’s CLIA certificate;

• impose a fine of $10,000 per day;

• suspend and cancel the lab’s approval to receive Medicare payments; and

• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.

Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)

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