Working Stiff by Dr. Judy Melinek hits bestseller list; death penalty off table for alleged Sonnier murder mastermind

Dr. Judy Melinek (PathologyExpert, Inc)

Dr. Judy Melinek (PathologyExpert, Inc)

Working Stiff

Dr. Judy Melinek, a forensic pathologist based in San Francisco, has written a book entitled Working Stiff which details her two years of training as a forensic pathology and forensic neuropathology fellow at the Office of the Chief Medical Examiner in New York City from July 2001 to June 2003.

Working Stiff has received some very positive reviews from USA Today, New York Times, Washington Post, and has earned 4 1/2 stars so far from readers on Amazon.

In addition, Working Stiff this week hit #21 on the New York Times bestseller list for E-book nonfiction.

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Shawn Parcells makes national news with Michael Brown autopsy

Shawn Parcells and Dr. Michael Baden (NYT)

Shawn Parcells and Dr. Michael Baden (NYT)

Mr. Shawn Parcells made national news this week when he participated in the second autopsy of Michael Brown, whose shooting death by local police on August 9, 2014 sparked significant ongoing unrest in Ferguson, Missouri.

Background

I first wrote about Mr. Parcells in May 2013 after an article in the St. Louis Post-Dispatch discussed concerns some Missouri prosecuting attorneys and county coroners had that Mr. Parcells, who only has a Bachelor’s degree, was performing unsupervised forensic autopsies without the appropriate qualifications.  Readers can refer to my earlier article or the Post-Dispatch piece for details.

Mr. Parcells contacted me via email a few weeks after my article went out and stated he wanted to “clear the air and present the truth”.  I called him back and we spoke for about 10 or 15 minutes, and then he provided me with a written rebuttal to the Post-Dispatch story.

Fast forward to August 2014.  After 18 year old Michael Brown was killed by Officer Darren Wilson, St. Louis County Chief Medical Examiner Dr. Mary Case performed an autopsy.  The family (or its attorney) then requested a second, private autopsy.

I was not the least bit surprised to see the family had asked Dr. Baden to perform the second autopsy, as there are very few forensic pathologists in this day and age who have the visibility and name recognition Dr. Baden has.

But I was very surprised to see Shawn Parcells standing on Dr. Baden’s right during the press conference in which the results of the second autopsy were revealed.

Media gets it very wrong

My surprise quickly turned to disappointment when I saw several large and experienced media organizations wildly misrepresent Mr. Parcells’ qualifications.

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ASCP seeks members’ opinions on Palmetto action; James Brady death ruled homicide

ascp_logoThe American Society for Clinical Pathology (ASCP) is asking for its members’ input on how the ASCP should proceed regarding recent actions by Medicare Administrative Contractor (MAC) Palmetto GBA regarding ancillary stain overutilization/fraud. In other news, former Reagan press secretary James Brady’s recent death has been ruled a homicide, which has generated some interest in the media about manner of death determinations.

ASCP/Palmetto

In its August 4th ePolicy news, the ASCP opened a dialogue with its members regarding the recent move by Palmetto GBA to limit the number of ancillary stains ordered on gastric and breast biopsies. Specifically, the ASCP wants to know what members think of both the purpose of Palmetto’s move (reducing fraud) as well as the process (skirting the local coverage determination (LCD) process).

The ASCP states it is appreciative of the fact Palmetto is seeking to curb Medicare fraud without affecting all pathologists equally (as reimbursement cuts do), but is concerned the 20% hard utilization ceiling is not flexible enough for all patient populations.

The ASCP acknowledges Palmetto is within its rights to set jurisdictional payment policy for Medicare, but states payment policies are normally set through the LCD process.  It is through the LCD process, the ASCP states, that stakeholders are able to provide MACs with clinical expertise regarding practice standards.

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LabCorp suffers setback in Pap test negligence suit

LabCorp

The Court of Appeals for the 11th Circuit has reversed a district court’s ruling in a Pap test negligence suit filed by a woman who claims she developed metastatic cervical cancer due to multiple misreadings of her Pap tests by LabCorp employees.

In its decision, the appellate court noted its disagreement with the district court’s reliance upon the Pap test litigation guidelines put together by the College of American Pathologists (CAP) and the American Society of Cytopathology (ASC).

Case details

I first wrote about this case way back in February 2012, when it was being heard by the district court.

Very briefly, Christina Adams had five Pap tests between January 2006 and September 2008, all of which were sent to LabCorp for interpretation.  Four of those were reported as normal (January 2006, January 2007, March 2008, September 2008), and one (October 2007) was reported as ASC-US.

Ms. Adams was diagnosed with cervical cancer in August 2009.  It is unclear to me based on what I have read whether it was metastatic when she was diagnosed or metastasized later.

She and her husband filed suit against LabCorp in September 2010, alleging it is liable for the negligence of its employees who “misinterpreted and reported inaccurate test results” that “permitted her cancer to metastasize.”

The plaintiffs hired Dr. Dorothy Rosenthal, a pathologist at Johns Hopkins University, as their expert witness.  Dr. Rosenthal performed a non-blinded review of only the Pap tests in question and nothing else and concluded:

…LabCorp’s cytotechnologists’ review of Ms. Adams’s slides fell short of the applicable standard of care by failing to identify abnormal cells that should have been identified.

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Jury finds oncologist negligent for withholding crucial information from pathologist

gavel

A Massachusetts jury found an oncologist was negligent when he failed to provide pertinent clinical information to a hematopathologist that may have prevented an erroneous diagnosis of non-Hodgkin lymphoma in a patient who subsequently died from treatment complications.

The jury rendered its decision back in March but I only first heard about the case last week when a reader sent me the July 25th newsletter from the ECRI Institute.

That newsletter referred to an article on page 14 of the June 2014 edition of Medical Malpractice Verdicts, Settlements, and Experts that discussed the malpractice suit.  The website requires a paid subscription, but I contacted the site, and a representative was kind enough to provide me with the full article as well as permission to reproduce it in its entirety here.  Many, many thanks to the good people at Medical Malpractice Verdicts, Settlements, and Experts for doing so.

Case details

Mr. Martin Harrity, who carried a pre-existing diagnosis of an unspecified immunodeficiency disorder that could reportedly mimic lung cancer, was under the care of Dr. James Rooney, a hematologist/oncologist.  In July 2003, Mr. Harrity, who was 39 years old at the time, had a biopsy of a lung mass, which was sent to an unnamed hematopathologist.  The pathologist rendered a diagnosis of non-Hodgkin lymphoma.

Per the article, Dr. Rooney did not tell the hematopathologist about the patient’s immunodeficiency.

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

(examiner.com)

(examiner.com)

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

DOJ

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 elected to intervene in July 2013.

The government alleged IHS, through its subsidiaries and clinics, paid physician-owned DPG “a percentage of collections on items and services performed or referred by DPG physicians” to IHS-affiliated clinics that performed clinical laboratory and diagnostic imaging tests from 2005 to 2011.  DPG then compensated individual physicians for their referrals.

The government stated IHS did this so as to:

…keep DPG and its physicians affiliated with [IHS], to prevent them from affiliating with competitors, and to induce DPG physicians to refer federal health care business to IHS subsidiaries…in violation of the Anti-Kickback Statute and the FCA.

According to a 2013 article from AL.com, it was also alleged federal health programs paid at least $521.6 million in false claims between 2004 and 2010, and physicians at DPG received more than $18.6 million in bonuses during the same time frame.

DPG deliberated its compliance with the Stark Law beginning as early as 2002, and again in 2007 and 2008, according to court records.  In June 2010, a meeting took place in which DPG’s attorney told both DPG executives and IMC employees their arrangement likely violated the Stark Law, but despite this, no changes were made.

Dr. Heesch will receive $4.41 million of the settlement.

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HHS seeks to dismiss suit filed by California Clinical Laboratory Association

HHS

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 determinations (LCDs) adopted by MACs are unconstitutional and “deprive Medicare beneficiaries throughout the country of critical clinical laboratory tests”
  • MACs are promulgating LCDs outside of the normal rule-making process as codified in the Administrative Procedure Act
  • MACs are using criteria to formulate LCDs that are not supposed to be considered
  • The Secretary of HHS is not ensuring nationwide consistency in the treatment of Medicare beneficiaries, as is required by Congress
  • HHS has made it so that laboratories are not allowed to appeal these LCDs by suspending the necessary portion of the administrative appeal process

HHS filed its memorandum in support of its motion to dismiss (MTD) on July 2, 2014 which states the suit should be dismissed because the court lacks proper jurisdiction over Jane Doe’s claims, the CCLA lacks standing to bring suit and the court lacks jurisdiction under the mandamus statute.

Jane Doe’s claims

According to the complaint, Jane Doe’s physician ordered pharmacogenomic testing for her that was sent to a laboratory in Virginia, but Medicare would not pay for such testing because of an LCD issued by Palmetto GBA.  Jane Doe claims “this non-coverage policy jeopardizes her and similarly situated Part B enrollees’ access to medically necessary laboratory services” which led her to become a plaintiff in this suit filed in federal court.

HHS argues Medicare beneficiaries may ordinarily only seek judicial review of MAC claim payment refusals in federal court after they have exhausted the administrative appeals process.  This consists of an appeal to the MAC that denied the claim, an appeal to another MAC, an appeal to an administrative law judge, and lastly, an appeal to the Medicare Appeals Council of the Departmental Appeals Board.

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Franey Medical Laboratories not guilty of Medicaid fraud and kickbacks

Franey Medical Laboratories (Capewide Enterprises)

Franey Medical Laboratories (Capewide Enterprises)

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 insurance kickbacks and filing false Medicaid claims.

As best I can tell from available sources, internist Dr. Richard Ng, who was charged with multiple counts of illegal prescribing, Medicaid false claims and Medicaid excess charges at the same time as the others, owned a drug abuse clinic as well as CML.

According to the Cape Cod Times:

In March 2007, Franey Medical Lab began doing urine drug screen tests for the Caritas Medical Lab in Brighton, where Andrews was the manager, according to court records filed by the state. At that time, Franey Medical Lab hired and began to pay three full-time employees who worked at Caritas and processed drug-screen tests for Franey, according to court records.

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OIG Issues Special Fraud Alert on Specimen Processing and Registry Arrangements

OIG HHSThe 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 for taking the time to do this.


It’s a rare day when the OIG issues a “Special Fraud Alert” specific to the lab industry, but it did so on June 25th.  The OIG is the Office of Inspector General at the Department of Health and Human Services.  It investigates healthcare fraud, most frequently under the Federal anti-kickback statute (AKS).   It’s a crime under the AKS to knowingly and willfully offer, pay, solicit or receive any remuneration to induce, or in return for, referrals of items or services paid for by any Federal health care program.  Violators commit a felony punishable by fines, imprisonment, and exclusion from Medicare.

The OIG has now highlighted two types of arrangements between labs and physicians that it considers “suspect” under the AKS:

  • Specimen Processing Arrangements — payments by a lab to referring physicians for collecting, processing and packaging specimens sent to the lab; and
  • Registry Arrangements — payments by a lab to referring physicians for submitting patient data to a registry or database, for instance, as part of the lab’s R&D program.

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