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News

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Labs Sue CMS Over Planned Cut

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December 12, 2017 Modern Healthcare – Virgil Dickson Clinical labs are suing the CMS over a planned multibillion-dollar cut to their reimbursement. They expect to lose $670 million next year as part of a CMS effort to pay the same … Continue reading

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FDA Issues Safety Alert: Potential Vitamin B7 Lab Test Interference

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U.S. Food and Drug Administration (FDA) Posted November 28, 2017 AUDIENCE: Laboratory, Health Professional, Patient ISSUE: The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests … Continue reading

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NMG Speaks at G2 Lab Institute 2017: Conference Ends With Optimistic Outlook for Laboratories

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October 30, 2017 G2 Compliance Advisor – Staff Writer Despite the PAMA cloud overhanging the laboratory industry, G2’s 35th annual Lab Institute conference (Washington D.C.; Oct. 25-27) ended on an optimistic note with David Nichols and Drea Langston, both from … Continue reading

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Cleveland HeartLab to be acquired by Quest Diagnostics

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October 18, 2017 Crain’s Cleveland Business – Chuck Soder Cleveland HeartLab has agreed to be acquired by Quest Diagnostics, a Fortune 500 medical testing company based in New Jersey. The deal should help the Cleveland Clinic spinout company accelerate its growth, … Continue reading

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Quest Diagnostics, Walmart to Provide Co-Branded Lab Testing Services

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June 27, 2017 360Dx – Staff Writers Quest Diagnostics and Wal-Mart Stores said today that they will provide laboratory testing services in about 15 Walmart locations in Florida and Texas by the end of this year. The collaboration is part … Continue reading

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FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

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April 12, 2017 FDA News Release The U.S. Food and Drug Administration today permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), the first whole slide imaging (WSI) system that allows for review and interpretation of digital surgical pathology slides … Continue reading

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CMS Will Give Labs More Time to Report PAMA-Required Payor Data

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March 30, 2017 GenomeWeb – staff reporter he Centers for Medicare & Medicaid Services has agreed to “exercise enforcement discretion” for 60 days, giving laboratories some more time to report private payor pricing data required under the Protecting Access to … Continue reading

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Vermillion’s Aspira Labs Secures Expanded Medi-Cal Coverage for OVA1

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March 7, 2017 GenomeWeb – Staff Reporter Vermillion said yesterday that its Aspira Labs subsidiary has won out-of-state provider status with Medi-Cal, California’s Medicaid program, for its OVA1 ovarian cancer test. The status gives the company access to more than … Continue reading

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LabCorp to Acquire Lab Diagnostics Player PAML

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February 23, 2017 FierceBiotech – Amirah Al Idrus LabCorp agreed to acquire Pathology Associates Medical Laboratories from Providence Health & Services and Catholic Health Initiatives for an undisclosed amount. “This signature transaction strengthens LabCorp’s relationships with anchor health systems and expands … Continue reading

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Acquisitive LabCorp in $8B PPD play: Reuters

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February 6, 2017 FierceBiotech – Ben Adams Medical testing company LabCorp is prepared to spend $8 billion on one of the largest CROs in the world, coming hot on the heels of it buying up New Jersey-headquartered Covance in an … Continue reading

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Quest Partners with Montefiore Health System

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January 26, 2017 MADISON, N.J. and NEW YORK, PRNewswire — Quest Diagnostics (NYSE:  DGX), the world’s leading provider of diagnostic information services, is working with  Montefiore Health System (MHS) to provide diagnostic laboratory services. This partnership will enhance the quality and efficiency of … Continue reading

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Health Organizations Urge Senate to Update LDT Oversight Rules

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January 26, 2017 GenomeWeb – staff reporter NEW YORK (GenomeWeb) – The American Cancer Society said today that its Cancer Action Network and 32 other healthcare organizations have sent a letter to congressional leaders urging them to update oversight rules … Continue reading

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David Nichols of NMG in CAP Today: Tough times demand superior business savvy

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January 2017 CAP Today – Ron Shinkman A selected section of this article provided below, but please read full article at CAP Today. Reimbursement policies, competitive forces, and pathologist workforce numbers will reshape pathology groups in the coming years, say … Continue reading

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LabCorp to Acquire Assets of Mount Sinai Health System Clinical Outreach Laboratories

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January 10, 2017 Yahoo Finance – BusinessWire Laboratory Corporation of America® Holdings (LabCorp®) (LH), a world leading life sciences company, and the Mount Sinai Health System (Mount Sinai), one of the largest health systems in metropolitan New York City, have … Continue reading

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Invitae Acquires Data Company AltaVoice

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January 6, 2017 GenomeWeb – Staff Reporter NEW YORK – Invitae announced today that it has acquired privately owned data company AltaVoice. Under the terms of the deal, Invitae purchased all of AltaVoice’s stock in exchange for $5 million in … Continue reading

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Grail is raising at least $1 billion to fund its early cancer screening test

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January 6, 2017 TechCrunch – Sarah Buhr The early cancer screening startup Grail plans to raise more than $1 billion in Series B financing, possibly up to $1.8 billion. While the company doesn’t want to name investor names, only mentioning … Continue reading

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David Nichols quoted in NYT re: Theranos

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June 8, 2016 Elizabeth Holmes of Theranos Is Barred From Running Lab for 2 Years The New York Times – Andrew Pollack Federal regulators have banned Elizabeth Holmes, the chief executive of Theranos, from owning or operating a medical laboratory … Continue reading

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NMG Advocacy Efforts

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June 27, 2016 We are pleased to be a part of advocacy efforts in both the education and environmental sectors. The Nichols Management Group donates 10% of net profits of environmental and educational non-profit organizations.             … Continue reading

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Quest Diagnostics Zika Virus Test Gets U.S. Approval

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April 29, 2016 Reuters – Ismail Shakil Quest Diagnostics Inc said it has received emergency authorization from the U.S. Food and Drug Administration to sell the first commercially developed diagnostic test for Zika in the United States, a step that may … Continue reading

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CMS Releases MACRA Rule Proposal

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April 27, 2016 FiercePracticeManagement – Matt Kuhrt The U.S. Department of Health and Human Services unveiled a proposed rule tackling the initial implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). According to an HHS announcement accompanying the … Continue reading

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FDA Clears First Blood-Based Colorectal Cancer Screening Test

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April 19, 2016 Lab Soft News – Bruce Friedman In the upcoming months, there surely will be an increasing number of blood-based genomic cancer tests approved by the FDA. This specific test market is just too attractive. In a recent … Continue reading

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Quest, LabCorp Forge Divergent Paths Through M&A

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April 13, 2016 Modern Healthcare – Adam Rubenfire Quest Diagnostics and Laboratory Corporation of America battle vigorously for market share in the diagnostic lab industry. And in recent years, both companies have made significant strides in expanding their businesses by … Continue reading

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Although Still in Infancy, DNA Sequencing Rapidly Evolving

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April 9, 2016 Milwaukee-Wisconsin Journal Sentinel – Kathleen Gallagher and Mark Johnson Late last year, DNA sequencing revealed that Teddy Blondheim, who turns 3 in July, has a rare genetic disorder. Teddy’s parents also learned there is no treatment, and … Continue reading

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Future Of LDT Oversight Still Uncertain

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April 2016 AACC – Kim Scott After years of back-and-forth on the issue, the debate over which federal agency will regulate laboratory-developed tests (LDT) going forward is far from settled. The Food and Drug Administration (FDA) says it has the … Continue reading

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Should Consumers Be Allowed to Order Their Own Lab Tests?

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April 10, 2016 Wall Street Journal – Michelle De Mooy & Roy Benaroch A growing number of Americans are taking control of their medical information, obtaining electronic records from their health-care providers so they can more easily keep track of their care … Continue reading

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83% of patients willing to donate leftover blood samples to research

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December 17, 2015 MedCity News – Meghana Keshavan Patients are getting more engaged in their care processes, which has led to an interesting new trend: We’re now seeing a more philanthropic patient. But not just in terms of donating dollars: Patients … Continue reading

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Precision Medicine May Leave Public Health Efforts in the Dust

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August 6, 2015 FierceHealthcare – Kyle Budryk The federal government and healthcare industry’s focus on personalized medicinecomes at the expense of public health efforts, argues an opinion piece published in the New England Journal of Medicine. Groups such as the … Continue reading

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Biomarker Proposed to Detect Traumatic Brain Injury

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August 10, 2015 Lab Soft News It has been long recognized that a biomarker to detect traumatic brain injury (TBI) would be very useful (see: NFL Physician Says Diagnosis of “Chronic Traumatic Encephalopathy” Lacks Validity; Pro Football Team Experiments with Cone … Continue reading

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FDA Focuses on Informatics Platform as Part of Precision Medicine Work

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August 6, 2015 FierceHealth IT – Katie Dvorak A new project by the the U.S. Food and Drug Administration will create a collaborative informatics community to help advance precision medicine. The project, precisionFDA, will be a crowd-sourced, cloud-based platform and … Continue reading

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Natera Raises IPO Goal to $175M

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July 2015 Diagnostics World News – Editor Natera’s IPO is looming, with the offering coming as early as tonight. Xconomyreports that in documents filed today with the SEC, the company raised its fundraising goal to $175 million. The company hopes … Continue reading

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Medicare now covers joint Pap smear and HPV tests for women 30 to 65

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July 9, 2015 Modern Healthcare – Virgil Dickson Medicare will now would pay for women to get a joint Pap smear and human papillomavirus test every five years to screen for cervical cancer, according to a final national coverage decision … Continue reading

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Quest Diagnostics to Acquire MemorialCare Health System’s Laboratory Outreach Service Business

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June 30, 2015 PR Newswire Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, and MemorialCare Health System, a nationally recognized nonprofit health system in Los Angeles and Orange counties, today announced they have entered into a definitive agreement … Continue reading

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Clinical integration saves Yale New Haven Health System $125 million

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June 29, 2015 Healthcare Finance – Susan Morse The Yale New Haven Health System said it saved $125 million, and all they needed to do was engage physicians in cost control. Yale created a process that linked financial and clinical … Continue reading

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Natera Sets Targets to Raise Up to $122M in IPO

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June 22, 2015 Silicon Valley Business Journal – Gina Hall Prenatal testing startup Natera set a target range for an IPO on Monday in which it hopes to raise up to $100 million. The San Carlos company led by CEO … Continue reading

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Price transparency full of challenges for health systems, consultants say

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June 23, 2015 Healthcare Finance – Henry Powderly Though Steven Brill’s essay “The Bitter Pill” has spurred demand for healthcare price transparency, competition and the complexities of value-based payment has made that a much harder goal than thought. “In a … Continue reading

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Opko Health agrees to buy Bio-Reference Labs in $1.5 billion deal

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June 4, 2015 MarketWatch – Ciara Linnane Opko Health Inc. OPK, +0.45% said Thursday it has agreed to buy Bio-Reference Laboratories Inc. BRLI, +0.23% in a deal valued at about $1.5 billion. Opko said it will pay 2.75 shares for … Continue reading

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MALDI in microbiology: Set to stun?

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May 2015 CAP Today – Anne Paxton In the business world, the term “disruptive innovation” is hot. In product launches, business plans, and job resumes, it’s become a standard part of the pitch. Like the flux capacitor in the fictional … Continue reading

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How to Hire the Best Healthcare Consultant for Your Hospital

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May 26, 2015 Healthcare Finance – Tammy Worth Kenneth Hertz took his first healthcare consulting engagement 10 years ago. On his very first day on the job, he identified some serious issues in the client’s organization and panicked. He was … Continue reading

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FDA Gives Greenlight to Roche C.difficile Test

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May 26, 2015 MedCity News – Stephanie Baum The U.S. Food and Drug Administration has granted 510(k) clearance for Roche’s test for C.difficile. Its Cobas Test targets the toxin B gene found in toxigenic C. difficile strains in stool samples from … Continue reading

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UMASS Memorial seeks stake in Quest Diagnostics subsidiary

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May 22, 2015 Boston Business Journal – Jessica Bartlett UMass Memorial Medical Center is looking to acquire a minority stake in Quest Diagnostics’ Massachusetts subsidiary, bringing the health system’s diagnostic testing business partially back under the wing of the medical … Continue reading

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College of American Pathologists’ Laboratory Standards for Next-Generation Sequencing Clinical Tests

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April 2015 PubMed.gov – Various Authors The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also … Continue reading

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HIV Home Test Kit Goes on Sale in UK

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April 27, 2015 BBC News – Smitha Mundasad The first legally approved HIV self-test kit that allows people to get a result in 15 minutes at home has gone on sale in England, Scotland and Wales. Unlike other kits, these … Continue reading

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OIG: Not charging a patient for laboratory testing could violate Anti-Kickback Statute

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April 1, 2015 The Pathology Blawg – Editor & Lee Dilworth The Office of the Inspector General (OIG) for the Department of Health and Human Services recently released Advisory Opinion 15-04, which discusses whether a laboratory that provides free services to out-of-network patients is violating the … Continue reading

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Aligning with Value Based Reimbursement

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March 23, 2015 Healthcare Finance – Carolyn Wukitch The stakes have been raised for payers and providers already besieged by a rapidly changing market. Last month HHS Secretary Sylvia M. Burwell announced an initiative to make alternative payment the standard for 50 … Continue reading

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2015: The Year of the Technologically Engaged Patient?

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March 3, 2015 Med City News – Amy Bucher The year 2014 brought several trends in health technology. Wearables and the quantified self continued to grab headlines, from the de-emphasis of the Nike Fuel Band to the launch of Runkeeper’s Breeze activity sensor app … Continue reading

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McDonald Hopkins: Collection and Handling Payments Under Scrutiny

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February 27, 2015 The Pathology Blawg – Jane Pine Wood of McDonald Hopkins Jane Pine Wood, a specialist in health law and member of McDonald Hopkins, recently sent me (The Pathology Blawg) the following Healthcare Alert that serves as a reminder the federal government … Continue reading

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White House Proposes $215 Million, New Regs for Precision Medicine

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January 30, 2015 Modern Healthcare – Darius Tahir The White House is proposing $215 million in new funds and new regulations in a sweeping effort involving the National Institutes of Health, the Food and Drug Administration, and the Office of … Continue reading

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The Future of Population Health Management

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January 25, 2015 Fierce Healthcare – Zack Budryk Healthcare leaders are under significant pressure to improve population health while containing costs. In fact, it’s one of their top priorities in 2015, according to a recent survey from B.E. Smith. To better … Continue reading

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JAMA Editorial Calls on Congress to Curtail Physician Self-Referral

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January 21, 2015 The Pathology Blawg Dr. Eli Adashi of Brown University and Dr. Robert Kocher of the Schaeffer Center for Health Policy and Economics at the University of Southern California, Los Angeles, have published an editorial in the Journal of the American Medical Association … Continue reading

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Should the Government Regulate Laboratory Developed Tests?

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January 8, 2015 Modern Healthcare – Jaimy Lee A federal proposal to begin regulating some types of laboratory tests will be addressed during a public workshop Thursday and Friday. Questions about the accuracy and marketing of some tests have raised … Continue reading

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