Of Theranos, ADLTs, and Surgical Pathology Errors

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THESE DAYS, IT SURE FEELS LIKE CLINICAL LABS AND PATHOLOGY GROUPS are under constant siege. Every month seems to bring one or more new developments that rock the clinical lab industry.

Theranos, Inc. is a prime example of this phenomenon. Almost every month there are new disclosures about problems plaguing this high-profile lab company. As you will read in this issue, CMS has imposed the most serious sanctions available under CLIA. In response, Theranos is taking actions that indicate it may be preparing to drop its clinical lab and direct-to-consumer strategies. Instead, it seems to be repositioning to focus on developing its diagnostic instruments and technologies for other purposes, while also pursuing FDA clearance for its devices and methodologies.

Meanwhile, CMS has issued the final rule to implement the lab test market reporting and ADLT sections of the PAMA statute. In this issue, we provide useful insights about the rule that addresses ADLTs. In this article, you’ll learn how experts in this field recommend that labs offering ADLTs assess their options. They point out that pricing decisions about a lab’s ADLT are about to become more complex. When Medicare sets a price for an ADLT in one year, that price will be published and known to private health plans. Thus, a lab’s proportion of public and private payers must be known to establish a pricing strategy for each ADLT that will produce optimal revenue.

Next in our line-up of intelligence briefings is coverage of a surgical pathology scandal unfolding in Kansas City. THE DARK REPORT is first in the lab industry to cover this story. According to a lawsuit filed by a whistleblower-pathologist at a major university medical center, the chair of pathology at that institution misdiagnosed a patient’s cancer, causing a healthy and essential organ to be surgically removed. Post-surgery, the lawsuit alleges the chair of pathology changed hospital records to cover up the error.

Court documents indicate that the hospital is pressuring the whistleblower-pathologist, while not acknowledging the medical error affecting this patient. Do The Joint Commission and the College of American Pathologists (accreditors of the hospital and the lab, respectively), know about the whistleblower’s complaint? Are they investigating? You’ll need to read the article to learn the answers to those questions and more.


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