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Spotlight Interview With Viracor’s Steven Kleiboeker
Viracor Eurofins Laboratories (Lee’s Summit, MO) is a specialty laboratory focused on infectious disease, immunology and allergy testing for immunocompromised and critical patients. Viracor is a 100% subsidiary of Eurofins Scientific (Luxembourg). Under the FDA’s...
More Testing Needed So Policy Makers Can Make Rational Decisions
Right now, sample collection kit shortages in the United States mean that Covid-19 testing has rightly been focused on the most severe symptomatic patients. But this is skewing our understanding of the virus and its true risks. And policy decisions that will have...
Harbert Wins Two Board Seats At Enzo Biochem
Two nominees from the Alabama investment management firm Harbert Discovery Fund (HDF) have won board seats at Enzo Biochem (New York City), following a vote at Enzo’s delayed shareholders meeting on February 25. Fabian Blank and Peter Clemens now represent 40% of the...
Why Were Hospital Labs Excluded From The Initial PAMA Survey?
A former CMS official involved in drafting the initial Medicare rules that determined which labs must report their private-payer pricing data to CMS for calculating Medicare CLFS rates says that PAMA was specifically designed to exclude hospital labs. This flies in...
UnitedHealthcare Requiring Hospital Outreach Labs To Contract As Independent Reference Labs
UnitedHealthcare (UHC) says that hospital labs cannot bill for non-patient outreach tests under their hospital’s facility participation agreement. UHC has had this policy in effect for more than one year. What’s new is that UHC now appears ready to actually enforce...
LabCorp Reports Full-Year 2019 Financial Results
LabCorp (Burlington, NC) reported net income of $823.8 million for the full-year 2019, down from $883.7 million in 2018. LabCorp’s overall revenue increased by 2.0% to $11.6 billion in 2019.Revenue from LabCorp’s lab testing business decreased by 0.4% to $7 billion in...
Quest Reports Full-Year 2019 Financial Results
Quest Diagnostics reported net income of $858 million for full-year 2019, up from $736 million in 2018. Quest’s overall revenue increased by 2.6% to $7.726 billion, with acquisitions contributing more than 2% to revenue growth. Quest’s average revenue per requisition...
Enzo Delays Shareholder Meeting; Harbert Files Lawsuit
Enzo Biochem (New York City) has delayed its annual shareholder meeting, originally scheduled for January 31, until February 25. The move comes as Enzo’s executives are engaged in a bitter battle with the Alabama investment firm Harbert Discovery Fund (HDF) over board...
Spotlight Interview with OmniPathology CEO Mohammad Kamal
OmniPathology (Pasadena, CA) was formed in 2009 with an initial focus on gastrointestinal pathology. The lab has 15 employees, five of whom are pathologists. Laboratory Economics recently spoke with Founder and CEO Mohammad Kamal, MD. What areas does Omni Pathology...
PAMA Reporting Period Delay Is Welcome News For Labs
On December 20, President Trump signed into law a spending package that included provisions of The LAB Act. The legislation delays the PAMAprivate-payer data reporting schedule by one year, in order to give more time for all labs, especially hospital outreach labs, to...
Shareholder Vote To Decide Enzo’s Fate
The activist hedge fund manager Harbert Management Corp. (Birmingham, AL) is seeking to replace two board members at Enzo Biochem (New York City) with its own nominees. A shareholder vote at Enzo’s annual meeting on January 31 will decide the matter. Harbert has...
DermTech’s Pigmented Lesion Assay Gets Medicare Coverage
DermTech (La Jolla, CA) received a Proprietary Laboratory Analyses CPT code (0089U) for its Pigmented Lesion Assay in late October, according to CEO John Dobak, MD. Medicare reimbursement has been set at $760 per test effective January 1. The Pigmented Lesion Assay...
Top Hospital-Based Outreach Labs by Medicare CLFS Payments
The vast majority of hospital laboratory outreach programs uses its hospital’s NPI and finance department for billing and is now required to report their private-payer data to CMS under PAMA. The table below lists the top 25 hospital-based labs based on their Medicare...
Enzo Hires Investment Bank Lazard
Enzo Biochem (New York City) has hired the investment bank Lazard to assist in “strategic relationships and new venture creation.” This news comes as Harbert Management Corp. (Birmingham, AL) has purchased a 12% equity stake in Enzo and nominated two new independent...
Exact Sciences Completes Genomic Health Acquisition
Exact Sciences (Madison, WI) finalized its purchase of Genomic Health (Redwood City, CA) on November 8. The deal was initially valued at $2.8 billion when first announced on July 29. However, a subsequent 30% drop in Exact’s shares lowered the deal value to $2.5...
More Executive Changes At Labcorp’s Diagnostic Division
After only a few days in the position, LabCorp Diagnostics’ CEO John Ratliff has resigned to take a top executive position at an unnamed company. Ratliff, age 59, had become head of LabCorp’s diagnostic testing business effective November 1. He had formerly been CEO...
The EKRA Law Banning Commission-Based Lab Sales Reps Remains In Effect
On October 24, 2018, The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) became law (see LE, December 2018). EKRA was part of broader legislation (The SUPPORT Act) intended to address the national opioid crisis. The EKRA law prohibits commission payments based on...
Top 25 Independent Nursing Home Labs
There are approximately 75 independent lab companies across the United States that are focused on the nursing home market. The table below lists the top 25 companies as measured by their volume of Part B services for G0471 in 2017 (the latest year of available data)....
Quest Diagnostics Buys Assets From Bankrupt True Health
True Health and its parent company THG Holdings have finalized a bankruptcy court-approved sale of their assets to Cleveland HeartLab, a subsidiary of Quest Diagnostics, for $8.5 million. The deal did not include True Health’s 100,000-square-foot lab in Richmond or...
Exagen Raises $58 Million From IPO
Exagen Inc. (Vista, CA) completed an IPO on September 23, raising gross proceeds of $58 million from the sale of 4.14 million shares at $14 per share. Net proceeds were approximately $54 million after deducting the underwriting discounts and commissions and other IPO...
Harbert Pushes For Change At Enzo
Funds managed by Harbert Management Corp. (HMC-Birmingham, AL) have purchased an 11.8% equity stake in Enzo Biochem Inc. (New York City) and nominated two new independent directors—Fabian Blank and Peter Clemens—to Enzo’s board. Enzo currently has a fivemember board...
uBiome Headed For Chapter 7 Liquidation
UBiome Inc. (San Francisco), which filed for Chapter 11 bankruptcy reorganization in early September, has moved to a liquidation under Chapter 7, after unsuccessful attempts to secure new loans or find a buyer. The company was founded in 2012 and had marketed its...
Laboratory Economics Issues Research Report on U.S. Anatomic Pathology Market
The report reveals that the anatomic pathology market (including Pap testing) now represents an estimated $18 billion of revenue with an annual growth rate of 3-4%. All data and trends are fully explained throughout the report, including 10-year historical data and a detailed three-year forecast.
A Closer Look At The Exact Sciences-Genomic Health Deal
Last month, Laboratory Economics took an abbreviated look at Exact Sciences’ blockbuster deal to acquire Genomic Health. Below we provide a more in-depth review of some of the interesting aspects of the agreement. The Bidding ProcessIn October 2017, Genomic Health...
PathGroup Buys Southeastern Pathology Associates
SEPA was started as an outpatient pathology laboratory in 1992 by its Medical Director Patrick Godbey, MD and Chief Medical Officer Mark Hanly, MD, who met while in training at the Medical College of Georgia. Over the next 20 years, their practice grew and they...
Study: Cologuard Less Effective And More Costly Than Alternatives
Exact Sciences’ Cologuard test is less effective at saving lives and more costly than other CMSreimbursed colorectal cancer screening tests, according to a study published September 4 in PLOS One, a peer-reviewed scientific journal published by the Public Library of...
Cancer Genetics Inc. Sells Businesses To Raise Cash & Lower Debt
Cancer Genetics Inc. (Rutherford, NJ) has sold its clinical lab business to siParadigm LLC (Pine Brook, NJ) for an initial payment of approximately $1 million, plus an earn-out based on test volume over the next 12 months. Cancer Genetics’ clinical lab business...
AMCA Data Breach Victim List Continues To Grow—What A Mess!
The list of laboratories affected by the data breach at American Medical Collection Agency (AMCA), which filed for bankruptcy on June 17, continues to grow. So far, at least 24 labs and more than 25 million patients are estimated to have been affected by the incident....
True Health Files For Chapter 11 Bankruptcy
True Health Diagnostics (Frisco, TX) filed for Chapter 11 bankruptcy protection on July 30, blaming CMS’s suspension of its Medicare payments since May 2017. In its bankruptcy filing, True Health said it had less than $50,000 of assets, and more than $100 million in...
Technical Rates for Many Pathology Services To Get Small Boost Under Proposed MPFS
The Proposed Medicare Physician Fee Schedule (MPFS) for 2020 includes a 5% hike to the technical component for CPT 88305, which, if finalized, would raise it to $32.12. Meanwhile, the rate for the professional interpretation is being lowered by a proposed 1% to...
ACLA Wins Appeals Court Decision; HHS Likely To Request Rehearing
On July 30, the U.S. Court of Appeals for the District of Columbia ruled in favor of the American Clinical Laboratory Assn. (ACLA) in its suit against the U.S. Department of Health and Human Services (HHS) regarding implementation of the Protecting Access to Medicare...
Top 20 Medi-Cal Laboratories
The largest Medi-Cal lab provider is The Genetic Disease Screening Program (GDSP) of the California Department of Health, which received $29.5 million of Medi-Cal FFS payments in calendar year 2018, according to the latest available data from DHCS. The Genetic Disease...
Debt Collection Company Hack May Affect 20+ Million Patients
Aweb payment page operated by American Medical Collection Agency(AMCA-Elmsford, NY) has been hacked and may have exposed personal data on 20+ million patients from at least three commercial lab companies: Quest Diagnostics, LabCorp and BioReference Labs. AMCA, which...
Public Lab CEOs Paid Average $4 Million
The chief executives at 17 publicly-traded lab companies were paid an average of $4 million each last year, according to an analysis of shareholder proxy statements by Laboratory Economics. Altogether, the 17 CEOs earned a total of $6 7.6 million, including $10.7...
Latest Medi-Cal Private-Payer Payment Survey Underway
California’s Medi-Cal lab fee schedule has been pegged to private-payer rates since 2015. California’s Department of Health Care Services (DHCS) is currently in the midst of its fourth private-payer rate survey, which will be used to set Medi-Cal reimbursement rates...
LabCorp CEO Dave King To Retire
LabCorp has announced that its CEO Dave King, age 62, will be retiring, effective October 31, 2019. Starting on November 1, King will become Executive Chairman of the Board through at least the end of 2020. He will also act as senior advisor to LabCorp’s new CEO, Adam...
When Will The EKRA Ban On Commission-Based Sales Reps Be Lifted?
As part of ongoing efforts to combat the nationwide opioid crisis, Congress enacted the SUPPORT for Patients and Communities Act (SUPPORT Act) effective October 24, 2018. As part of the SUPPORT Act, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018...
What Kind Of Company Is 23andMe?
A study led by researchers at the genetic testing lab company Invitae (SanFrancisco, CA) found that 23andMe’s direct-to-consumer BRCA test forhereditary breast cancer misses almost 90% of BRCA mutation carriers. 23andMe has been criticized for offering the test...
Largest Nursing Home Lab Company Seeks Bankruptcy Reorganization
Trident Holding Company (Sparks, MD), the nation’s largest nursing home lab operator, filed for Chapter 11 bankruptcy reorganization in the Southern District of New York on February 11. Trident, which employs 4,500 full-time workers and 660 people part time, provides...
Many Hospital Labs Still Don’t Know They Must Report PAMA Data
On January 22, the Centers for Medicare & Medicaid Services (CMS) hosted a teleconference that focused on a new rule that requires nearly all hospital outreach labs to collect their private-payer payment data from January 1 to June 30, 2019, and report it to CMS...
Special New Year’s Report: Lab Execs Share Outlook for 2019
For an inside look at what may be in store for the clinical lab and pathology business this year, Laboratory Economics interviewed the top executives at a diverse group of 10 lab companies. Not surprisingly, our interviews revealed that commercial insurers are using...
Does New Far-Reaching Anti-Kickback Law Apply To All Labs?
Hastily passed opioid legislation, signed into law by President Trump on October 24, outlaws the use of volume-based compensation for laboratory sales reps, regardless of the type of testing involved. The new law, Section 8122 of the “Eliminating Kickbacks in Recovery...
GAO Warns Of Increased Costs From Unbundling Panel Tests
A new report from the U.S. Government Accountability Office (GAO) has zeroed in on the unbundling of common panel tests as a practice that could cause Medicare to overpay billions under PAMA’s new market-based CLFS. The potential for overpayment stems from a loophole...
UltraClinics Aims to Spread Telepathology
UltraClinics Inc. (Tucson, AZ) has begun marketing a telepathology service that will allow diagnostic imaging centers and outpatient surgery centers to offer their patients same-day anatomic pathology reports from on-site tissue biopsies, Ronald Weinstein, M.D., 67,...
Redwood Toxicology Sold For 3.3x Revenue
The investment firm American Capital Strategies (Bethesda, MD) has paid $79.5 million for a 67% stake in Redwood Toxicology Laboratory (Santa Rosa, CA). Redwood’s management team, including chief executive and founder Bob Mount, owns the remaining 33%. The deal, which...