As prostate biopsy is one of the most commonly performed office procedures in urology, it is not surprising that it also one of the most controversial. Disagreement exists not only around the optimal prostate-specific antigen (PSA) level at which to perform biopsy and increasing infection rates associated with the procedure, but also around even more basic issues, such as the proper sampling pattern, the number of cores routinely collected, and the optimal approach to collecting and processing the pathology specimens. This last issue is particularly complicated because there are significant financial incentives associated with the way prostate biopsy specimens are submitted and processed. Effectively, Medicare and other payers reimburse pathology laboratories based upon on the number of specimen vials submitted for analysis. In other words, a 12-core biopsy submitted in 12 vials is reimbursed at a higher rate than if the same 12-core biopsy were submitted in 6 or fewer cores. Of course, if this is supported by scientific evidence, it should be considered medically appropriate and cost issues should be secondary. Unfortunately, there are those in Washington, DC, who have published reports wrongly accusing our specialty of performing unnecessary biopsies and submitting pathology specimens in a manner that maximizes profit as opposed to practicing evidence-based medicine and providing high-quality patient care.^1,2 

In this issue of Reviews in Urology, Kapoor and colleagues³ present data that respond directly to these prior flawed reports and demonstrate that urologists, regardless of whether they have a financial interest in an in-house pathology laboratory, currently use 10 to 12 unique specimen vials when performing prostate biopsies. Although it may be an overstatement to say that the use of 10 to 12 unique specimen vials is the standard of care, this study documents that it is now routine clinical practice to use 10 to 12 unique vials. The question that remains unanswered is whether it is medically necessary to use 10 to 12 specimen vials. An American Urological Association white paper panel recently reviewed the literature on the subject and concluded that urologists should place no more than two prostate biopsy cores in any single vial to maximize diagnostic accuracy.⁴ This is not to say that the panel recommended against placing each core in its own vial for routine diagnostic biopsies. Rather, the panel was unable to find conclusive evidence showing a diagnostic benefit to this approach when compared with using two cores per vial. It is important to note that the current study finds a strong correlation between positive biopsy rate and number of specimen vials submitted per vial. Although this information does not conclusively prove that using a single vial for each core is the optimal approach, it certainly provides some preliminary support for this practice.

Sadly, it is unlikely that this or any other study will definitely determine the optimal way to label and process routine diagnostic prostate biopsy specimens. This means that the debate in Washington over whether it is science or reimbursement driving clinical practice in this setting will continue. Given that it may prove impossible to generate the necessary clinical evidence to inform practice, perhaps the best way to end the debate is to change the reimbursement model around prostate biopsies. Those who accuse urology of increasing the number of vials submitted at the time of biopsy suggest that the solution is to simply prohibit urologist ownership of in-house pathology laboratories. This likely will result in inefficiencies of care and/or our colleagues in pathology requesting that we send off prostate biopsies in as many vials as possible, so that they can maximize their reimbursement. Neither of these results is desirable. I would submit the following modest proposal: it is time is to abandon the fee-for-service approach to the pathologic processing of prostate biopsy specimens and replace it with a single, reasonable fee for the service, regardless of the number of vials submitted. After all, as surgeons, we do not get paid more for removing 10 versus 20 lymph nodes at the time of prostatectomy or cystectomy, even though it often requires greater surgical effort and extended templates to increase lymph-node counts. Acknowledging this, why should pathologists get paid by the lymph node? Simply pay a single fee based upon a 10- to 12-core biopsy regardless of the number of vials submitted. In fact, one could even take it a step further and develop a bundling package that covered all costs around prostate biopsy (including initial consultation, surgeon’s fee, etc). This would allow greater control of costs and would address policymaker’s concerns of financial incentives around ownership and the way biopsies are processed. This is the future of how reimbursement will work in American health care and it would speak volumes about our specialty if we took the lead in making this happen.  

References

1. Mitchell JM. Urologists’ self-referral for pathology of biopsy specimens linked to increased use and lower prostate cancer detection. Health Aff (Millwood). 2012;31:741-749.
2. US Government Accountability Office (GAO). Medicare: Action Needed to Address Higher Use of Anatomic Pathology Services by Providers Who Self-Refer. GAO-13-445.Washington, DC: GAO: 2013.
3. Kapoor DA, Bostwick, DG, Mendrinos SE, et al. ­Utilization trends and positive biopsy rates for prostate biopsies in the United States: 2005 to 2011. Rev Urol. 2013;15:137-144.
4. Bjurlin MA, Carter HB, Schellhammer P, et al. Optimization of initial prostate biopsy in clinical practice: sampling, labeling, and specimen processing. J Urol. 2013;189:2039-2046.