It has been some time since I have talked about self-referral of prostate biopsies, so I thought I would revisit the issue with a little help from Dr. Jonathan Epstein.
Dr. Patrick Walsh speaks out
Late last year, Dr. Patrick Walsh, an internationally-recognized urologist who specializes in the study and treatment of prostate cancer at Johns Hopkins, made provocative comments in two high-profile publications regarding urologist self-referral of ancillary services.
The first was a Bloomberg article on how the medical needs of patients with prostate cancer and the financial “wants” of self-referring urologists may conflict. In that story, Dr. Walsh is quoted as saying:
After hormones became less lucrative, the pattern shifted, said Patrick Walsh, former director of the Brady Urological Institute at Johns Hopkins University.
“All of a sudden there was a blanket menu of things that were done that aren’t necessary,” Walsh said. “Every patient gets a urine culture, an abdominal ultrasound. There’s general overuse of equipment that the large urology groups own, such as CT scans and IMRT — anything to maximize income.”
To be fair to all parties involved, the clinicians featured in the Bloomberg story vehemently object to the article and a website has been created to explain their side of the story.
Enter Dr. Jonathan Epstein
The second was an editorial written by Dr. Walsh in the Journal of Urology regarding Dr. Jean Mitchell’s study in Health Affairs that looked at urologist self-referral of prostate biopsies. In that editorial, Dr. Walsh made a couple of interesting statements.
First, he stated Dr. Jonathan Epstein (who probably every practicing pathologist has heard of) does not believe putting each prostate core in its own container is necessary. Second, he stated Dr. Epstein has observed many urologists with in-office pathology labs hire the “cheapest pathologist possible”, implying quality takes a back seat to profit. Additionally, Dr. Walsh also claimed in one recent two-week period, Dr. Epstein personally examined three cases from in-office labs in which all carried a diagnosis of extensive prostate cancer. Two of the patients reportedly had no cancer at all on their biopsies and the third had only focal cancer after Dr. Epstein’s review.
Naturally, Dr. Walsh’s statements caught my eye, and I sent an email to him asking if he would be willing to talk more with me about what Dr. Epstein told him. He very politely recommended I contact Dr. Epstein.
Obviously Dr. Walsh then reached out to Dr. Epstein even before I had a chance to, because the next morning I received an email from Dr. Epstein. He told me he had written a soon-to-be-published letter to the editor of the Journal of Urology that would help to clarify things.
That letter was published in the January 2013 edition. In it, Dr. Epstein confirms Dr. Walsh indeed quoted him accurately with respect to in-office labs. Dr. Epstein then went on to clarify that overall, the pathologists who staff in-office labs are excellent, but the quality of pathology in in-office labs could be “less than optimal” if the clinician owners do not commit fully to putting out quality pathology results.
What Dr. Epstein did not address in his letter, however, was whether Dr. Walsh correctly quoted him regarding the medical necessity of placing each core of a 12 biopsy procedure in its own container (what I refer to as “12 in 12″). I have long argued putting each core in its own container is not medically necessary and only serves to run up the bill.
A brief “12 in 12″ review
Proponents of “12 in 12″ have claimed the NCCN guidelines recommend putting each core in its own container. Back in July 2012 Mr. Joe Plandowski of In-Office Pathology wrote the following in a rebuttal on his website to some of the things I had written about self-referral of prostate biopsies:
It appears that the Blawg’s anonymous author has not read the National Comprehensive Cancer Network’s (NCCN’s) protocol on Early Detection of Prostate Cancer. If he had, he would not be mocking the taking of 12 cores from the prostate and putting each core in a separate vial.
I have never said performing twelve biopsies is unnecessary. In fact, the NCCN clearly recommends doing so. But despite reading the NCCN guidelines on prostate cancer multiple times, I was never able to find the recommendation for placing each core in its own container.
Because I knew “12 in 12″ proponents would never believe me, I went straight to the source and contacted the NCCN directly.
The NCCN asked Dr. James Mohler, a urologist and chair of the NCCN Guidelines Panel for Prostate Cancer, to help me out, and he did. He responded:
The prostate biopsies need be distinguished, at a minimum, as left or right and apex or other because poorly differentiated cancer in the apical biopsies should cause one to consider whether nerve preservation is appropriate.
So clearly the NCCN does not feel placing each core in its own container is medically necessary, yet proponents of “12 in 12″ still advocate its use.
We are meant to believe it is mere coincidence the reimbursement for “12 in 12″ is double that of “12 in 6″.
Now back to Dr. Epstein
After his letter was published, I emailed Dr. Epstein again and asked him whether he feels placing each core in its own container is necessary. I also asked him how the urologists at Johns Hopkins submit their prostate biopsies. He responded:
I feel that in general it is better to put 2 cores per cassette as opposed to 1 core as it with uncommon exception does not impact patient care.
He further elaborated:
…you typically do not lose information by submitting in 6 jars with 2 cores each as opposed to 12 jars with 1 core each.
Dr. Epstein also stated the urologists at Hopkins submit two prostate cores in each container for six total containers.
So there you have it
Dr. Jonathan Epstein, who understands prostate cancer better than perhaps any other human being on earth, believes placing each core in its own container is typically not medically necessary.
He is in good company. The NCCN, the Departments of Urology at Johns Hopkins and the University of Michigan, and a myriad of others with the ability to look at the issue sans profit motive feel the same way.
I just don’t understand how “12 in 12″ is allowed to continue when so many medical experts say it is not necessary.
I would like to sincerely thank Drs. Walsh and Epstein for working with me on this issue.