Pathology Blawg News Roundup for April 17, 2015


Sustainable Growth Rate finally, amazingly, repealed

After 17 years of kicking the can down the road, both chambers of Congress finally passed, and President Obama signed, a bill to repeal the flawed sustainable growth rate formula (SGR) that is used to calculate physician reimbursement through Medicare.

In addition to preventing a 21% reimbursement cut to physicians, the bill extends funding for the Children’s Health Insurance Program and community health centers by two years, funds the National Health Service Corps, and will increase physician reimbursement by 0.5% in the second half of 2015 and by 0.5% each year from 2016 to 2019.

The repeal will cost around $214 billion over the next ten years (as compared to “only” $117-$138 billion a year ago), with $73 million of that offset by requiring high income beneficiaries to pay more for their care and by cutting reimbursement to hospitals and nursing homes.

The American Clinical Laboratory Association, through a press release it sent me, commended Congress for the repeal.

More thoughts on JAMA breast pathology study

On March 23rd, I wrote an article about the poorly-conceived study that was published in the Journal of the American Medical Association (JAMA) that found the study pathologists were only able to “correctly” diagnose breast biopsies about 75% of the time.  Dr. Keith Kaplan over at The Digital Pathology Blog, and Dr. Michael Misialek also wrote very nice articles about the study.

The JAMA study was featured at the New York Times, National Public Radio (both over the radio and in print), PBS News Hour, the Seattle Times, a JAMA press release to the media, the Chicago Tribune CBS Boston, the Breast Cancer Consortium, Medscape, and others.  A reader sent me an email a week after the study was published that said, among other things, patients were already requesting a second opinion of their breast biopsies based on what they had seen/read about the study.

I was curious how the College of American Pathologists (CAP) responded, and found a statement critical of the study from CAP president Dr. Gene Herbek on the CAP website, a “CAPcast” featuring Dr. Jean Simpson, and a CAP-sponsored Twitter chat.

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Could pathology client billing arrangements now run afoul of OIG guidance?

Mr. Andy Lemons

Mr. Andy Lemons, an attorney with Smith Moore Leatherwood who works with laboratories on regulatory and transactional matters, sent me a recent article he wrote in which he questions whether the most recent Advisory Opinion (AO15-04) from the Office of the Inspector General (OIG) for the Department of Health and Human Services "could indicate an emerging view at the OIG that would jeopardize most [pathology] client billing arrangements." For those just joining us, the OIG released … [Continue reading]

United States intervening in lawsuits against BlueWave Healthcare Consultants, Berkeley HeartLab

I received an email the other day from whistleblower law firm Phillips and Cohen which contained a press release about the $47 million settlement agreement Health Diagnostic Laboratory (HDL) entered into with the Department of Justice to settle allegations it paid kickbacks to physicians. The settlement covers allegations made against HDL in three whistleblower lawsuits, one of which had been filed by Phillips and Cohen. The PR also notes clinical laboratory Singulex will pay $1.5 million … [Continue reading]

Pathology Blawg News Roundup for April 10, 2015

Health Diagnostic Laboratory lays off more employees Health Diagnostic Laboratory (HDL), one of the laboratories that is being investigated by the Office of the Inspector General for the Department of Health and Human Services for potentially providing illegal kickbacks to physicians, laid off 42 of its employees last week, which amounted to about 6% of its workforce.  HDL laid off 132 of its employees in late 2014, which at that time was approximately 16% of its personnel. Legal actions … [Continue reading]

More thoughts on recent exclusive laboratory arrangement ruling from OIG

AP2 logo

Last week I published a summary of Advisory Opinion 15-04 from the Office of the Inspector General (OIG) for the Department of Health and Human Services put together by Mr. Lee Dilworth, Chief Legal and Administrative Officer of American Pathology Partners.  In that Opinion, the OIG ruled a lab which chooses to not bill for laboratory services provided to out-of-network patients with a commercial insurance plan that requires the insured to exclusively use a different lab could … [Continue reading]

Quest Diagnostics subsidiary Celera to pay $23 million to settle securities laws violation allegations

Celera logo

Clinical laboratory Celera, a Quest Diagnostics subsidiary, will pay $23 million to settle allegations brought by the Washtenaw County (Michigan) Employees’ Retirement System in a class action lawsuit.  The county alleged Celera violated federal securities laws by making "materially false and misleading statements to investors regarding Celera’s business and financial results" between March 31, 2008 and March 28, 2009 (the class period) that caused its stock price to be artificially … [Continue reading]

American Association of Bioanalysts: Laboratory-developed tests are not the practice of medicine

AAB logo

Attorneys for the American Association of Bioanalysts (AAB) disagree with the argument put forth by Paul Clement and Laurence Tribe, counsel to the American Clinical Laboratory Association (ACLA), that laboratory-developed tests (LDTs) represent the practice of medicine and therefore cannot be regulated by the Food and Drug Administration (FDA) as medical devices. It is important to note that although the AAB disagrees that LDTs are the practice of medicine, the AAB still believes the FDA's … [Continue reading]

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

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 federal Anti-Kickback Statute (AKS).  According to Mr. Lee Dilworth, Chief Legal and Administrative Officer of American Pathology Partners, "the factual situation is nothing new, but the OIG’s conclusion and its rationale may surprise many." Once … [Continue reading]

Reader has strong opinion about JAMA breast pathology study

Last week I wrote about the new study in JAMA that found pathologists were only able to “correctly” diagnose breast biopsies about 75% of the time.  I felt the study design forced the pathologist participants to diagnose the breast biopsies in a manner that was not consistent with how most pathologists practice, and the study was therefore not as useful as it could have been. One pathologist reader, whose practice has already received patient requests for second opinions of their breast … [Continue reading]

Health Diagnostic Laboratory to pay $47 million to settle kickback allegations

Mr. John Carreyrou at the Wall Street Journal is reporting Health Diagnostic Laboratory (HDL) has reached a tentative deal with the government to pay $47 million to settle allegations it paid kickbacks to physicians in exchange for test referrals. Background In September 2014, the WSJ published an article that stated the Office of the Inspector General for the Department of Health and Human Services was investigating the $20 per specimen payment HDL remitted to referring physicians as a … [Continue reading]

American Clinical Solutions accuses Pinnacle Laboratory Services of paying kickbacks to docs

ACS logo

American Clinical Solutions (ACS), a urine drug testing laboratory in Florida, has filed a lawsuit against one of its competitors, Pinnacle Laboratory Services, that alleges Pinnacle engages in an illegal kickback scheme that "promises to provide physicians with hundreds of thousands of dollars annually." I only recently learned of the existence of the suit, which was filed in July 2014 and is still in the discovery phase, but it is interesting nonetheless because the alleged scheme is very … [Continue reading]

JAMA study casts doubt on pathologists’ ability to diagnose breast biopsies

  The results of a study that found participating pathologists were only able to "correctly" diagnose breast biopsies about 75% of the time was published last week in the Journal of the American Medical Association (JAMA).  While I am in no way dismissing the entirety of the study, I believe it required pathologists to practice in an artificial manner and its results are therefore not a true reflection of most pathologists' ability. Study Design The study authors randomly selected … [Continue reading]

Judge quashes pathology researcher’s subpoena to unmask anonymous PubPeer commenters

A Wayne County Michigan Circuit judge has determined, with one possible exception to potentially be decided today, the website will not be compelled to turn over the identities of anonymous commenters that pathology researcher Fazlul Sarkar, PhD alleges defamed him and led to the loss of a job offer at the University of Mississippi and loss of tenure at Wayne State University. I wrote about this case back in November 2014, and I will rely heavily on that post to provide … [Continue reading]

Contributor to Palmetto GBA ancillary stain local coverage determination speaks out

I received this comment from a (frustrated) member of the College of American Pathologists (CAP) House of Delegates who helped write the ancillary stain local coverage determination (LCD) policy for Medicare Administrative Contractor Palmetto GBA. With the member's permission, I am posting the comment in its entirety. Hopefully there will be a good discussion on this topic at the House of Delegates meeting that begins March 21st, because it is a very important issue. When I was in … [Continue reading]

Leading urologist still denying urology was caught with its hand in the self-referral cookie jar

Patrick McKenna, MD (

Urologist Dr. Philip Hanno, an editorial consultant for Urology Times, recently interviewed Dr. Patrick McKenna, former chairman of the Judicial and Ethics Committee for the American Urological Association (AUA).  One of the major subjects of the interview was urologist self-referral, and Dr. McKenna did a masterful job of attempting to show urologists who engage in self-referral of anatomic pathology and intensity-modulated radiation therapy (IMRT) for prostate cancer are in no way abusing … [Continue reading]