TAG:

genetic testing labs

Labs May Be Excluded from Revised Stark, AKS Rules

CEO SUMMARY: When CMS and the OIG issued proposed rules last fall to make it easier for providers to participate in value-based and coordinated care arrangements, they considered excluding clinical labs, pharma companies, and DME firms because of concerns that the proposed rules could pro…

Read More



Labs May Be Excluded from Revised Stark Law, AKS Rules

This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…

Read More



Medicare Affiliation Rule Targets Criminal Behavior

CEO SUMMARY: Under a new federal rule in effect this month, all healthcare providers—including clinical laboratories and pathology groups—will need to scour the records of all officers, directors, and affiliates to identify any that have had negative dealings with CMS or other federal…

Read More



PGx Testing Labs Concerned by FDA’s Statements, Actions

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…

Read More



PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…

Read More



Theranos News Gets Worse for the Former Silicon Valley Hero

CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ ci…

Read More



Holmes, Balwani Indicted by Department of Justice

CEO SUMMARY: Federal criminal indictments were unsealed last Friday in San Francisco against Elizabeth Holmes and Ramesh “Sunny” Balwani for their actions as executives at Theranos, Inc., the once high-flying lab test company. Officials at the Department of Justice said the counts aga…

Read More



Myriad to Buy Counsyl, to Gain Presence in NIPS Test Sector

LATE LAST MONTH, Myriad Genetics Inc. announced a definitive agreement to acquire Counsyl, Inc., an innovative genetic testing company in South San Francisco, Calif., for $375 million. In a deal that is expected to close by early next year, Myriad will use a combinat…

Read More



March 5, 2018 Intelligence: Late Breaking Lab News

“More people took genetic ancestry tests last year than in all previous years combined,” declared Senior Editor Antonio Regalado in a story published on Feb. 18 by MIT Technology Review. He wrote that, just in 2017, the number of people who had their DNA analyzed with direct-to-consumer genetic g…

Read More



Big Payers Want to Bring Order to Genetic Testing

IMPORTANT CHANGES ARE POISED TO TRANSFORM genetic testing. As this happens, there will be a new crop of winners and losers among genetic testing labs. Recent events can be interpreted as favoring two trends that most genetic testing companies consider as unfavorable to their interests. One trend is …

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Need A Group Membership? Company Discounts are Available!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

Powered by Americaneagle.com

Hosted by Americaneagle.com, Inc.