$15.8 million award against LabCorp for Pap smear error cut to $4.4 million



A district judge in Florida has reduced the damages a jury ordered LabCorp to pay to the family of a woman who died of cervical cancer from $15.8 million to $4.4 million.

I first wrote about this case back in April, not long after the jury rendered its verdict.  Briefly, 33 year old Darian Wisekal began feeling “ill” in 2007.  A workup in 2008 included a Pap smear, which was reportedly read as negative by a LabCorp cytotechnologist.

Mrs. Wisekal was due to have another Pap smear in 2009, but reportedly on the advice of her physician, she postponed it until the following year.  The Pap smear performed in 2010 was also read as negative by a LabCorp cytotechnologist.

Within a week of the second negative Pap smear, she was hospitalized and diagnosed with cervical cancer, to which she succumbed the following November.

Her family sued LabCorp, claiming it was negligent when its cytotechnologist missed “high grade lesions” that were present on her 2008 pap smear.

LabCorp argued in court documents that it was not negligent, that Mrs. Wisekal’s tumor was “not subject to detection by a pap smear”, and that she was at fault for not “obtain[ing] a pap smear in 2009″.

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College of American Pathologists files formal complaint with CMS about Palmetto GBA

CAP logo

The College of American Pathologists (CAP) has filed a formal complaint with the Centers of Medicare and Medicaid Services (CMS) about the recent attempts by Medicare Administrative Contractor (MAC) Palmetto GBA to tamp down pathology fraud. The complaint focuses on an educational article about appropriate utilization of ancillary stains for gastric biopsies that Palmetto posted on its website on May 30, 2014. Briefly, Palmetto, citing recent literature articles, stated ancillary … [Continue reading]

California Clinical Laboratory Association fires back at HHS secretary


The California Clinical Laboratory Association (CCLA) has filed its opposition to the Department of Health and Human Services' (HHS) Motion to Dismiss (MTD) the CCLA's lawsuit that alleges local coverage determinations (LCDs) are unconstitutional. I first discussed this case in early May, a couple of weeks after the CCLA filed suit, and again just a few days ago after HHS filed its MTD.  Please see those posts for more information. What follows is a summary of the CCLA's response to … [Continue reading]

Laboratory referral kickbacks at heart of $24.5 million settlement and Indian TV sting op

Health Minister Dr. Harsh Vardhan

US lab kickback settlement Alabama-based Infirmary Health System (IHS), Infirmary Medical Clinics (IMC), Diagnostic Physicians Group P.C. (DPG) and two clinics run by IMC have agreed to pay $24.5 million to settle allegations they violated the Stark Law and Anti-Kickback Statute by engaging in a scheme to compensate physicians for laboratory and radiology referrals. Dr. Christian Heesch, a physician formerly employed by DPG, filed the whistleblower suit in 2011, and the federal government … [Continue reading]

HHS seeks to dismiss suit filed by California Clinical Laboratory Association

The Department of Health and Human Services (HHS) is seeking to dismiss the lawsuit brought against it by the California Clinical Laboratory Association (CCLA) back in April 2014 for lack of jurisdiction. I went into more detail about CCLA's allegations in an article back in early May.  Basically, the CCLA and a Jane Doe co-plaintiff allege: Congress has unlawfully delegated regulatory power to Medicare Administrative Contractors (MACs), and therefore the local coverage … [Continue reading]

Pathology Blawg News Roundup for July 18, 2014

ARUP Labs opposes release of draft FDA regulations for laboratory-developed tests Last week I talked about the letter five US senators wrote to the White House asking it to compel the Office of Management and Budget (OMB) to release draft guidance prepared by the Food and Drug Administration (FDA) on the regulation of laboratory-developed tests (LDTs). In that article I discussed how Dr. Edward Ashwood, president and CEO of ARUP Laboratories, indicated his opposition to FDA regulation of … [Continue reading]

OIG identifies questionable clinical laboratory billing in new study

The Office of the Inspector General for the Department of Health and Human Services (OIG) issued a report last week that found over 1,000 clinical laboratories in the United States "had unusually high billing for five or more measures of questionable billing for Medicare lab services."  As a result, OIG made three recommendations on how to deal with this issue, and the Centers for Medicare and Medicaid Services (CMS) accepted all three. Why OIG performed this study The OIG highlights the … [Continue reading]

CMS releases 2015 Proposed Physician Fee and Clinical Laboratory Fee Schedules

LCD summary table

The Centers for Medicare and Medicaid Services (CMS) recently released the Proposed Rules for the 2015 Physician Fee Schedule (PFS) and Clinical Laboratory Fee Schedule (CLFS) and the news is actually pretty good for pathology. I will not get into too much depth here.  Those interested in more detail can refer to the Proposed Rules themselves, or the very nice summary put together by the American Society for Clinical Pathology (ASCP). Prostate biopsy codes Just last year CMS introduced … [Continue reading]

Pathology Blawg News Roundup for July 11, 2014

Aurora Diagnostics completes two acquisitions On July 1st, Aurora Diagnostics announced it has completed two previously-announced acquisitions: Mid-Atlantic Pathology Services Inc. of Sterling, Virginia, and Hallmark Pathology of Medford, Massachusetts. House Oversight Committee has concerns about FTC action against LabMD The House Committee on Oversight and Government Reform has written a letter to the acting Inspector General of the Federal Trade Commission (FTC) stating it has concerns … [Continue reading]

Senators push White House to release FDA laboratory-developed test regulations

Five US Senators have written a letter to the acting director of the White House Office of Management and Budget, asking it to release draft guidance from the Food and Drug Administration (FDA) on the regulation of laboratory-developed tests (LDTs). The letter discusses how LDTs have historically escaped FDA regulation because they were simple, well understood tests for low risk or rare diseases that were performed only on patients who were being seen at the same facility at which the … [Continue reading]

Franey Medical Laboratories not guilty of Medicaid fraud and kickbacks

Franey Medical Laboratories (FML), a Massachusetts drug testing lab, and its vice president, Kathleen Franey-Lopes, have been found not guilty of providing kickbacks for Medicaid and private insurance patients, and of filing a false Medicaid claim. Charges were originally filed against FML, Ms. Franey-Lopes and the office manager of drug testing laboratory Caritas Medical Laboratory (CML), Renee Andrews, back in March 2013.  Ms. Andrews was charged with accepting Medicaid and private … [Continue reading]

LabCorp and UnitedHealthcare to introduce BeaconLBS in Florida


On October 1, 2014, UnitedHealthcare (UHC) will roll out its Laboratory Benefit Management Program in Florida, which will be administered by Beacon Laboratory Benefit Services, Inc. (BeaconLBS), a wholly-owned subsidiary of LabCorp. According to the "About" page of the BeaconLBS website: BeaconLBS® is a laboratory benefit solutions company that enables health plans, physicians and network labs to connect and deliver high-quality, cost-effective care to patients. BeaconLBS® is … [Continue reading]

OIG Issues Special Fraud Alert on Specimen Processing and Registry Arrangements

The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a Special Fraud Alert on June 25th that discusses how specimen collection and registry arrangements between laboratories and referring physicians may violate the Anti-Kickback Statute (AKS). Once again, Mr. Lee Dilworth, Chief Legal and Administrative Officer of American Pathology Partners, offered to explain just what this means for laboratories. Many, many thanks to Mr. Dilworth … [Continue reading]

LabCorp wrests upstate NY VA contract away from Quest Diagnostics

A federal judge has sided with LabCorp in its post-award bid protest of an upstate New York Veteran's Administration (VA) contract that had been awarded to Quest Diagnostics. I originally wrote about this case on June 11th, right after the judge had ruled on whether two declarations from LabCorp experts were admissible.  The judge filed this final decision under seal a few days later, but it only became available to the public on June 23rd. Briefly, the VA recently awarded a contract … [Continue reading]

Health Care Development Services report on projected pathologist shortage

Health Care Development Services, Inc. (HCDS), a hospital laboratory and pathology management consulting firm run by Mr. Barry Portugal, has released a Client Alert on the shortage of pathologists the US is projected to experience in the coming years and decades. The following is an introduction provided by Mr. Portugal about the Alert: The audience for the Alert was primarily executive leaders at our hospital, healthcare system, academic medical center, and pathology group clients. … [Continue reading]