There is a new development in one of the whistleblower lawsuits filed against several lab companies that offered specialty cardiology tests. Earlier this month, the Department of Justice announced a settlement with Quest Diagnostics involving its acquisition of Berkeley HeartLab, which was acquired by Quest in 2011. The DOJ said that Quest agreed to pay
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for
CEO SUMMARY: Among the major themes to emerge from the more than 60 sessions and 100 speakers at this year’s Executive War College on Lab and Pathology Management were the accelerating pace of integrated care, the growth of precision medicine, and use of big data to guide physicians. Other issues centered on labs’ need to
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 said, pursuant to terms of the settlement, CMS withdrew revocation of the company’s CLIA operating
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 year, sales of several major hospital lab
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: Every laboratory in the United States is watching how the federal
CEO SUMMARY: It’s becoming a familiar story. In Houston, a pharmacogenomics lab company started strong in 2011, then payments dropped sharply when Medicare issued restrictive new guidelines for PGx testing. Next, the Medicare administrative contractor handling the claims of CompanionDx Reference Lab canceled the lab’s registry and stopped paying most Medicare claims. In the wake
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 of labs that reported and the volume
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 office laboratories is that the federal Centers for Medicare
SINCE MEDICARE OFFICIALS PUBLISHED the final rule for lab test market price reporting of private payer prices last year, clinical lab industry consultants and lawyers have raised serious criticisms of the rule.
The critics recognized that CMS officials wrote a final rule for the Protecting Access to Medicare Act (PAMA) that excluded from reporting large numbers