TAG:
clinical lab
Federal Regulation of LDTs Subject of Proposed Bill
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…
More Hospitals Consider Options for Their Labs
CEO SUMMARY: Is it a new sign of the times? After decades of reluctance to sell their lab outreach businesses or enter into inpatient lab management agreements with commercial lab companies, a surprising number of hospitals and health systems are taking that step. Since the first of the y…
April 24, 2017 Intelligence: Late Breaking Lab News
Theranos, Inc., is again in the news. On April 17, the company disclosed a global settlement with the federal Centers for Medicare & Medicaid Services (CMS) to resolve “all outstanding legal and regulatory proceedings between CMS and Theranos.” The company sa…
Is CMS Manipulating Data to Increase Medicare Fee Schedule Cuts?
This is an excerpt from a 2,150-word article in the April 3, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: E…
Will Medicare Lab Test Fee Cuts Happen in 2018?
CLINICAL LABORATORIES THROUGHOUT THE UNITED STATES ARE BRACING for what Medicare officials say will be fee cuts of $400 million in 2018 alone, followed by additional cuts that will total $5.4 billion over 10 years. Of great concern to community laboratories, small and rural hospitals, and physician …
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
ARUP Laboratories Earns CAP’s ISO 15189 Accreditation
CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitmen…
Texas Lawmakers Asked to Stop UHC and BeaconLBS
CEO SUMMARY: In a letter to the Texas Legislature, 20 Texas medical societies say UnitedHealthcare’s BeaconLBS program would be detrimental to patient care. The Texas Medical Association and the Texas Society of Pathologists said they were concerned that the program increases the admini…
Lab Acquisitions: LabCorp, Quest, Sonic Do Hospital Lab Deals
This is an excerpt from a 1,021-word article in the March 13, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: …
Are Clinical Labs Prepared for What Is to Come?
IT IS TIMELY TO ASK THE QUESTION, “Are the nation’s clinical laboratories prepared to deal with the multiple challenges already visible in the healthcare marketplace today?” What leads me to ask this question is the unexpected number of deals involving the hospital lab outreach programs announ…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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