In a wide-ranging Q&A, Proscia Co-founder and Chief Product Officer Nathan Buchbinder outlines why digital pathology adoption will be aided by a new set of CPT codes, and how it is already proving beneficial to clinical laboratories just a few years after its first FDA approval

By Chris Wolski

New diagnostic technologies can bring the promise of better results for patients, more overall efficiency, and an improved bottom line. But there’s a catch. Often reimbursement for these tests lag behind proof of its clinical efficacy.

This is the case for digital pathology. Since being first approved by the U.S. Food and Drug Administration (FDA) in 2017, digital pathology has proven itself in labs across the country, but reimbursement for it has often been difficult or non-existent.

In a wide-ranging interview with CLP, Proscia Co-founder and Chief Product Officer Nathan Buchbinder discusses how a new set of CPT codes may aid ongoing adoption of digital pathology, why he sees digital pathology adoption as a set of successive waves, and the three benefits it brings to every lab.

Answers have been edited for length and clarity.

CLP: What’s the biggest issue facing labs in adopting digital pathology? Is it reimbursement or is it something else?

Nathan Buchbinder: The reality is that shifting from microscope to whole slide image is a transformative change for any laboratory. Just as we’ve seen with digital transformations across other healthcare domains and industries more generally, pathology’s move to digital isn’t simply a matter of implementing new technology. It’s about leveraging that technology to optimize processes, empower people, and unlock new value. Doing so successfully means aligning a diverse group of stakeholders, defining clear goals and use cases, and reimagining existing ways of working—all in addition to deploying technology.

This effort is proving to be worthwhile no matter where you look for evidence. Studies have demonstrated that digital pathology delivers meaningful productivity and efficiency gains. We’re seeing more and more press releases announcing that laboratories are going digital as a result.

Getting back to your question, I don’t think it’s fair to suggest that reimbursement is the biggest challenge plaguing laboratories when it comes to adoption. Added reimbursement tied to the use of digital pathology, however, would provide another avenue for laboratories to realize its value and create even more incentive to make the transition. 

CLP: What are the new CPT codes? Will they add transparency to billing and reimbursement itself? If so, how?

Buchbinder: In January, the American Medical Association introduced 13 new CPT Category III codes for digital pathology. This is a big development because until these codes went into effect, laboratories had no way to report when they used digital pathology vs. the microscope.

Category III codes are temporary and specifically for emerging technologies, services, and procedures. The digital pathology codes are also add-on codes, meaning that they must be used along with the appropriate Category I code. Services are still reimbursed based on the Category I code, no matter if the read was digital.

Regardless, the new CPT codes pave the way for added reimbursement. They finally provide payors with the data they need to understand the use and impact of digital pathology, and this is a critical step.

CLP: Let’s turn directly to reimbursement—what are some of the challenges facing labs today related to reimbursement?

Buchbinder: As anyone reading could attest, the big challenge is that reimbursement rates have almost universally been in steady decline. This is not a new trend by any means, but its impact continues to intensify and add to the pressures that laboratories are facing from staffing shortages, growing demand for their services, and rising expectations for precision medicine.

To compensate, laboratories are now looking to drive efficiency so that they can process more volume. This is where digital pathology, powered by a digital pathology platform like Proscia’s Concentriq Dx*, comes in. Among its capabilities, Concentriq Dx streamlines collaboration and centralizes diagnostic data to help drive meaningful productivity gains. It is also designed to help laboratories realize the promise of pathology’s AI-powered future.

In addition, digital pathology is enabling laboratories to tap into new revenue opportunities to make up for declining reimbursements. Because it allows pathologists to read cases from anywhere, laboratories can grow their subspecialist expertise and serve patients across a much wider geography.

CLP: One of the big issues facing labs today are personnel shortages. How is digital pathology helping to fill these gaps, and what does that mean overall for clinical labs and reimbursement?

Buchbinder: Let me start by noting that the workforce shortage is—and has been—one of the key drivers of digital pathology adoption. It’s commonly cited that between 2007 and 2017, the U.S. pathologist population declined by 17.5%.[1] More recently, an analysis of the 2021 College of American Pathologists Practice Leader Survey indicates that only 65% of practices looking to hire pathologists could fill all open positions, marking a decline from 2017.[2]

Digital pathology is helping to fill this gap in three main ways—two of which I just touched on. It’s driving productivity and efficiency so that laboratories can keep pace, and it’s also enabling them to pull in experts no matter where these subspecialists are located.

What’s more, digital pathology is helping laboratories to attract and retain talent. Efficiency gains can improve pathologists’ work-life balance. Pathologists are also extremely committed to patient care. By streamlining collaboration, for example, digital pathology can improve diagnostic confidence, and AI can act as a second set of eyes to further ensure quality. 

Consider that technology is a major draw for the digital-first generation of younger pathologists as well. They recognize that pathology and digital pathology are increasingly becoming one and the same and want to leverage the latest innovations as they establish their careers.

CLP: When and how will digital pathology reach an adoption tipping point? Are these CPT codes part of that equation?

Buchbinder: I’d argue that we’ve already seen digital pathology adoption reach a few tipping points. This is why I like to think about it in waves instead.

Here in the U.S., the first wave was led by early innovators before there were any regulatory approvals. Another wave was sparked in 2017 after the first FDA clearance. We saw yet another wave brought on by COVID when digital pathology proved to be the only viable solution for laboratories that suddenly needed to operate remotely.

I’d suggest that we’re in the midst of another wave right now. This wave has resulted from the growing base of evidence on digital pathology—and AI—adoption. The experiences of all the laboratories that went digital during COVID, as well as the growing number of studies, have generated meaningful momentum. The waves are crashing together and amplifying as adoption continues to accelerate.

To that end, it’s probably not surprising that we’re speaking with some laboratories that see the CPT codes as an added reason to go digital. I am confident that once they are associated with additional reimbursement value, they will initiate yet another wave that further drives adoption. In fact, in some European countries where reimbursement pathways or payment structures for digital pathology have been in place for years, adoption is nearing 100%.

Chris Wolski is chief editor of CLP.

REFERENCES

[1] Metter DM, Colgan TJ, Leung ST, Timmons CF, Park JY. Trends in the US and Canadian Pathologist Workforces From 2007 to 2017. JAMA Netw Open. 2019;2(5):e194337. Published 2019 May 3. doi:10.1001/jamanetworkopen.2019.4337

[2] Gross, D. et al (2022). Strong Job Market for Pathologists: Results From the 2021 College of American Pathologists Practice Leader Survey. Arch Pathol Lab Med 2022; doi: https://doi.org/10.5858/arpa.2022-0023-CP

*Concentriq Dx is CE-marked under IVDR and is available for primary diagnosis in the U.S. during the COVID-19 public health emergency.