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In-house or send-out? Lab approaches to gene panels

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Also in the strategy realm is biobanking. It becomes a whole new frontier, coupled with how to deal with the molecular strategy. There’s a lot of interest in leveraging the value of the EHR and looking for patients who are failing front-line therapies. Pharma has a lot of interest in knowing those individuals, as well as the underserved population that goes with this. It’s part of a larger strategy that we see as significant and relevant to our future as pathologists.

If we look two or three years out on this strategic vision, will you have more molecular pathologists and in-house capability?
Dr. Dysert (Baylor Scott & White): I hope it goes the way of IHC, which started off being almost a subspecialty but with knowledge transfer to subspecialty surgical pathologists. My hope is that the molecular group, because it’s a small number of people, can stay on the bleeding edge of technology and transfer knowledge and technology back to our surgical pathologists as they gain the experience and insight of working with these tumor boards and site conferences.

This will be essential to having the kind of faculty in oncology that an outfit like Baylor Scott & White aspires to and needs in order to achieve its mission.
Dr. Dysert (Baylor Scott & White): One of the first questions candidates ask is, “What’s your capability in-house?” or “What are your partnerships?” And the point about data that others made is important to answering their requests as well.

Ian McHardy, you have a hotbed of academic and community pathology and systems in California. What’s your take on this area now?
Ian McHardy, PhD, D(ABMM), director, microbiology, molecular, and immunology laboratory, Scripps Health, San Diego: It’s an area we continue to explore. We’re monitoring the situation in much the same way others are. We know it’s expensive and will evolve in the future. Since we don’t have the molecular oncology expertise in-house and we’ve only had a histology lab for just over a year, we don’t have immediate plans to insource. We agree that identifying strategic partnerships to minimize costs while improving care is a possibility, but this is complicated by rapid evolution in the competitive landscape. We have been looking at ways to integrate the results into discrete elements in Epic, but that also is complex and therefore continues to be an investigation.

Frank Beylo, what is your system doing regarding NGS?
Frank Beylo, BS, MT(ASCP), director, operations and technology, Inova Health Systems, Falls Church, Va.: We’re in the middle of a Beaker implementation, and we’re including Epic’s genomic module as part of the implementation and interfacing with Foundation and Tempus as part of that project. We’re slated to go live in January 2024 with Beaker, so we’re in the throes of validation and testing, but we’re also trying to standardize, using Foundation or Tempus, sending to one or two places to streamline that.

Rick Vander Heide, what are your views around this question of NGS?
Richard S. Vander Heide, MD, PhD, MBA, medical director, pathology and laboratory medicine service line, Marshfield Clinic Health System, Marshfield, Wis.: We’re struggling with this now. We have a small oncology group but one that is aggressive in terms of ordering molecular tests. What is necessary for patient care and what is academic interest is tricky. We do not have in-house capabilities; we send everything out mostly to Foundation. It’s expensive. Similar to what Clark said—let’s not jump into it, let’s figure out what we need to do and what value we can add to the system without compromising other efforts.

Robert Carlson, fill us in on what’s going on at NorDx.
Robert Carlson, MD, medical director, NorDx, MaineHealth: We have formed a precision medicine council and an oncology subgroup to drive consensus around what panels and markers are the most appropriate. We’re upgrading our NGS platform and focusing on the myeloid panel to start. We use Tempus.

We’re struggling with preauthorization and its timeliness and the burden of getting those markers reimbursed. That drives a lot of what we’re considering to bring in-house in terms of timeliness of care. It’s a volatile area now that we’re paying attention to.

Elizabeth Grasmuck, what’s going on in Little Rock?
Elizabeth Grasmuck, MD, associate professor of pathology, laboratory/pathology service line medical director, and vice chair of clinical operations, Department of Pathology, University of Arkansas for Medical Sciences: We’re looking to bring some NGS in-house. Like others, we are sending to different providers such as Foundation. Standardization is the direction we want to move in and then ideally do as much as we can internally. We have a strong group of molecular pathologists who have been helping us find our way.

Michele Erickson-Johnson, how is Sanford exploring NGS?

Dr. Erickson-Johnson

Michele Erickson-Johnson, PhD, HCLD/TS (ABB), MB(ASCP)CM, senior director of laboratory operations medical genetics and biorepository and enterprise laboratory quality, Sanford Laboratories, and assistant professor of internal medicine, University of South Dakota Sanford School of Medicine: We hired a molecular pathologist last year and are looking into bringing our own cancer panel in-house by working with our oncologists to identify the right panel. Sanford currently monitors the quality indicators from the companies that currently do panel or NGS testing as a send-out. The San­ford medical genetics laboratory molecular pathologist is taking the information from what the companies are offering in panel testing and the quality considerations into how the medical genetics lab will develop a gene panel for Sanford.

Greg Sossaman, can you comment on what you’ve heard in this discussion?
Gregory Sossaman, MD, system chairman and service line leader, pathology and laboratory medicine, Ochsner Health, New Orleans: We use some of the same labs others do for NGS. We have a molecular tumor board and a lab stewardship committee, and we established a subcommittee of that devoted to precision medicine molecular genetics. It has allowed us to dive deeper into the preauthorization and reimbursement issues. We’re trying to be careful around our investments. If you’ve seen one example of how someone is using NGS, you’ve seen one example because there are so many variations.

Preauthorizations are a big part of esoteric pathology these days, whether NGS or not. What has been your recent experience at Ochsner?
Dr. Sossaman (Ochsner): Some of these companies that advertise are pretty aggressive. They’ll claim that patients are only liable for a certain amount on the front end, but then we hear from the physician group about complaints from patients on the back end about what they are really billed. It’s on us to be careful about who we’re choosing as partners for these laboratories. We have looked into building into Epic a pre-work process, which is surprisingly complicated to automate. Those will be more common in the future because we will have to be more cognizant of the expense as many molecular tests become embedded in our subspecialties, like for neuropathology, hematopathology, et cetera. I think we’ll see more commercial and other insurers focused on the preauthorization process. It’s worth looking at how your institution does it and how it can become more automated and robust.

Epic has an orders and results interface but it doesn’t say it’s a billing interface. It’s worth our time and effort to focus on those more manual processes.

If you’ve seen one module, you’ve seen one module, and the connections are not always turnkey.
Dr. Sossaman (Ochsner): That’s right. The orders and results interface that they’re standing up and the agreements with Foundation and Caris and other laboratories to be a hub instead of point-to-point interfaces seem to be the direction they’re going. I’m not sure it will help with standardization because most of us build our Beaker or Epic systems and they’re all a bit different. It will be interesting to see how that works out.

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