Clinical relevance, financial feasibility, and workflow efficiency guide account managers as they help physician offices integrate established and cutting-edge cancer assays into patient care.
By Jim Poggi
The role of an experienced distribution account manager is multifaceted, encompassing both product offerings and pricing for customers. It is essential to ensure that everyday medical and surgical items are delivered on time, at the right price, and with consistent quality.
Our trusted manufacturers have done an exceptional job helping us, despite recent supply chain disruptions. Our ability to provide private label products has also helped account managers keep our customers’ costs in line in the face of the challenges they experience.
Declining reimbursements and scarcity of qualified personnel, coupled with increases in wages and costs of healthcare and property insurance, are all factors that keep even our most loyal customers coming to us with requests for better prices and, in worst cases, shopping our prices against our competition. The medical and surgical business is our core connection to our customers and needs to be front and center from an economic and product availability viewpoint. Consultants would tell us that the key customer facing success factors in the medical and surgical business are price and availability. No one who has been in this business for any length of time could argue that these factors are significant.
From time to time, regulatory issues such as removal of substances believed to be harmful to patients and caregivers (latex allergies are a good example) as well as providing a safe and accessible environment for all patients, even those with disabilities, have also become part of the medical and surgical landscape.
But, overall, it is a largely consistent business marked by exceptional product quality and range, with occasional innovations. We deliver excellent products on time, every time, and at market price. If we were grading our performance in school, I would give us an A- and expect every experienced distribution account manager to challenge me that we should get an A.
The lab business, on the other hand, has an entirely different level of challenges. We provide products for patient health screening, follow up and assessment of treatment effectiveness. Our job is to assure that we provide clinicians with products that answer the question they think about daily: “Will this product help me initiate or modify a patient treatment program?”
I assess whether we are providing relevance and value to our customers by considering our offerings compared to the list of the 10 leading causes of death. As I review the leading causes of death our customers encounter every day, the landscape for lab products is a dynamic one, especially for the diseases they experience most frequently: heart disease, cancer, diabetes and stroke. I have eliminated some of the 10 leading causes of death from this listing, since we either have established products with little change over time (kidney disease) or sadly, there is no current lab test available to help diagnose or guide treatment (unintentional injuries). An up-to-date listing of the leading causes of death (morbidity and mortality) can be found at the Center for Disease Control and Prevention’s National Center for Health Statistics web site: www.cdc.gov/nchs/fastats/leading-causes-of-death.htm.
This column will focus on cancer diagnosis and ask the question: If we believe the three elements of value are clinical, economic and workflow, how well do established tests available in the market stand up against the new alphabet soup of new molecular tests?
Every day we hear about ctDNA (circulating tumor DNA), mDNA (methylated DNA), miRNA (microRNA), NGS (Next-generation sequencing), qPCR (quantitative PCR) and other words new to us being brought to market in academic research centers and large reference labs. Our customers have questions about the future of lab testing. They expect us and our trusted lab manufacturers to come to them with answers.
Which tests should they perform now, and which tests are likely to be available soon, at reasonable prices to improve their ability to properly diagnose and treat their patients?
Are the new molecular assays the future? Are they complementary to established assays we currently offer? Or will they shift the balance of testing back to core labs and large private reference labs?
Before we discuss the three elements of value and how our customer value proposition aligns with current cancer screening technology compared to these newer technologies, let’s look at the world of reimbursement. For many years we were accustomed to providing financial value as a part of our customer value proposition in the physician office market. As PAMA and private insurance have reduced reimbursement, this element of value has become more difficult to present easily and credibly.
The story of the Clinical Lab Fee Schedule (CLFS) Reimbursement Schedule
Even though PAMA continues to be on pause, maybe never to return, the CLFS had one revision each quarter of 2024. That number of revisions is significant.
What happened? From the first quarter of 2025 to the fourth quarter of 2025, 62 new CLFS codes were introduced. The biggest change related to the CLFS in 2025 has been the number of new tests added to it.
Which ones are beneficial to the physician office lab?
Two molecular assays for hepatitis C (G0567 and G0567QW) and four for respiratory panels 0563U (11 viral, 4 bacterial targets) and 0564U, (10 viral and 4 bacterial targets) were introduced, each having a QW modifier. All these CPT codes are associated with products we can sell in the physician office. As a result, they help us round out the lab product portfolio we offer to our customers.
What is the balance of the new CPT codes all about?
The balance of the new CPT codes is for new molecular assays which are CLIA complex and run on new testing platforms, either qPCR or NGS. Most of these tests are sophisticated methods for providing information for cancer predisposition or to understand the best treatment plans for patients with cancer knowing how well their current program is working and the extent to which their cancer may be mutating to evade the treatment program.
Remarkably, there are a few other nuggets to share about the new assays available on the CLFS. First, there are now 186 tests that reimburse at least $1,000. Nearly all of them involve ctDNA, NGS or qPCR assay methods.
An increasing number of them also compare the patient result to a large database of test results (on the patient’s DNA or the DNA or RNA of their tumor itself). With databases expanding daily based on the increased use of these assays and the availability of AI, I expect the trend of comparing specific patient results with large databases to predict outcomes to continue to grow and to become more accurately predictive and answer the question: Is the screening result for the patient truly positive, or how does the tumor DNA compare to others and what level of risk can be assigned to this specific patient’s tumor? The term “personalized medicine” has been with us for a while, but these large databases along with sophisticated data mining and analytical tools are making it a reality for cancer diagnosis and especially for cancer treatment follow up.
The first multianalyte assays with algorithmic analysis (MAAA) are already available for prostate cancer, so we can see a path to the future in which multiple immunoassays are combined with a level of predictive analysis to improve sensitivity and specificity of cancer test results. I expect this trend to continue using currently available immunoassay technology well before newer technologies migrate into our market.
It is highly unlikely these complicated, cutting-edge assays will migrate down to the physician office lab – at least any time soon. The analytical systems they use and the databases they query and analyze are not yet ready for wide-scale product availability and adoption. But don’t sell our trusted lab manufacturers short. I am confident they are actively working on innovations in physician office tests. Our customers are closest to the patient and there is reason to believe we will see many of these tests in our market at some point. Availability of MAAA tests points to potential innovations in our market. Stay in close touch with your trusted lab manufacturers to understand their future plans.
Remembering what we sell now
This may seem like a yawner for most highly experienced distribution account managers but should serve as a guide to the tests our physician office customers use most frequently for cancer diagnosis for the less experienced distribution account manager. And, from time to time, we all need a reminder of our testing portfolio.
These tests include:
| Tumor Marker Tests Overview | ||||
| Test Name | CPT Code | 2025 Clinical Lab Fee Schedule reimbursement | Typical Diagnostic Use | Comment |
| Prostate Specific antigen (PSA) | 84153 | $18.39 | Prostate cancer | Often used with Free PSA |
| Free Prostate Specific Antigen (Free PSA) | 84154 | $18.39 | Prostate cancer | Often used with PSA |
| Carcinoembryonic antigen (CEA) | 82378 | $18.96 | Colorectal, others | |
| Alphafetoprotein (AFP) | 82105 | $16.77 | Liver, ovarian, others | |
| CA 19-9 | 86301 | $20.81 | Pancreatic, gastric | |
| CA 27-29 | 86300 | $20.81 | Breast | |
| CA 125 | 86304 | $20.81 | Ovarian cancer | |
| CA 15-3 | 86300 | $20.81 | Breast cancer | Often used to detect recurrence |
In addition to these instrument-based tests listed above, we need to remember FIT or fecal immunoassay tests. These waived tests are used as screening assays for colorectal cancer. Their CPT code is 82274 QW (as a waived test) and they reimburse $16 under the CLFS.
So, knowing that our current position in tumor marker assays is likely to remain stable for a while, how do these assays stack up against the cutting-edge assays beginning to enter the market using the three elements of value? I have made an assessment of our currently available technology in comparison to newer testing methods for each of the three elements of value. These assessments are mine and may not match those of others, but I believe they capture the mainstream views of this comparison.
| Clinical Value Element | ||
| Needed Product Attribute | Currently Available POCT Tests | New Technology (qPCR, NGS, others) |
| Broad range of well-established tumor markers | Yes | Mostly treatment guiding |
| Assays available on widely available testing platforms | Yes | No |
| Cost per test is reasonable | Yes | No |
| Kit sizes usually designed for the physician office | Yes | No |
| Reimbursement is established | Yes | Yes, some |
| Multiple manufacturers support these tests | Yes | To some extent |
| Many of these tests are screening tests | Yes | Some |
| Their specificity meets screening needs | Some | Yes, some |
| Financial Value Element | ||
| Needed Product Attribute | Currently Available POCT Tests | New Technology (qPCR, NGS, others) |
| Reimbursement | Mid-teens to low $20s per test; paid to who performs the test; likely due to high installed base | Unlikely due to tests being CLIA high complexity, personnel requirements and complex technology but high for those who do in the $1,000 range |
| Staff costs | Moderate: staff capable of performing moderate complexity tests satisfactorily; no specific support staff | High: high level staff requirements include lab director, technical supervisor, clinical consultant, general supervisor, testing personnel |
| Equipment costs | Moderate: several suppliers who serve the POL | High: continuing to evolve as new technologies are introduced; few suppliers who serve the POL beyond respiratory |
| Workflow Value Element | ||
| Needed Product Attribute | Currently Available POCT Tests | New Technology (qPCR, NGS, others) |
| Test menu breadth | Tests performed on large menu instruments used for thyroid and other tests; no special learning curve | Tests performed on highly sophisticated systems; likely new and unfamiliar. Long learning curve |
| Test time | No tests require multiple hours | Some tests require multiple hours |
| Test interpretation | Typically no complicated interpretation | Some require comparison to large data bases and complex interpretation |
| Send out test considerations | Send out tests have equivalent workflow but more tests are likely to be sent out | Send out tests have equivalent workflow but fewer tests are likely to be sent out |
| Personnel qualifications | Unlikely to require new more highly trained personnel | Likely to require new more highly trained personnel |
As we consider our customers’ needs for cancer screening and follow up, it is clear to me that the portfolio of needed tests is clearly split between tests suitable to be performed in the POL given the right personnel qualifications and test volume and those that should be sent out.
How should we consider the balance? It starts with knowing our customer well: do they have the right instrument in-house to perform these tests now? Does their test volume make adding some or all these immunoassay tests a viable patient care and economic solution? Is their staff ready, willing and able to take on these new tests?
What I like about considering the option of presenting immunoassay tests for cancer screening and diagnosis is that it takes the same skills we use to have a customer consider any new lab testing. As an added bonus as we consider which customers may be candidates for this testing, it should also help us deepen our relationships with our key lab manufacturers.
As you consider presenting this range of tests to your customers, keep the three elements of value in mind. Knowing your customer well and having a clear understanding of how they consider the three elements of value should help you quickly develop a list of “best few” customers for cancer tests.
Selling what we have now to create a higher level of value for our key customers will pave the way for them to consider us first as new technologies migrate down to our market.