A long-term study shows increasing rates of therapy-related AML as cancer survival improves, pushing clinical laboratories to expand genomic testing, enhance surveillance, and prepare for more complex secondary malignancies.
A new population-based study published in CANCER, a journal of the American Cancer Society, signals a growing diagnostic and surveillance challenge that clinical laboratories should take note of. Rates of therapy-related acute myeloid leukemia (tAML), a secondary blood cancer linked to prior chemotherapy and radiation exposure, are rising.
Researchers analyzing data from the Osaka Cancer Registry found that tAML incidence increased steadily between 1990 and 2020. Among nearly 10,000 AML cases, 6.5% were therapy-related, with incidence rising from 0.13 to 0.36 per 100,000 people. The proportion of tAML within total AML cases nearly doubled over the study period, reflecting a shifting disease burden tied to improved cancer survival.
âThe study provides an important step towards better understanding how the nature of tAML is changing with the increasing number of cancer survivors,â said lead author Kenji Kishimoto, MD, PhD, of the Osaka International Cancer Institute.
For clinical laboratories, the findings underscore the downstream impact of modern oncology treatments. As more patients survive primary cancers, labs are increasingly likely to encounter complex secondary malignancies requiring advanced hematologic testing, molecular profiling, and longitudinal monitoring. tAML, in particular, is associated with prior DNA damage from cytotoxic therapies, often presenting with aggressive clinical features and distinct genetic signatures.
The study also highlights changing patterns in primary cancers preceding tAML. While prior blood cancers remained the most common precursor, cases following breast cancer treatment rose notably over time, suggesting evolving risks tied to treatment regimens and survivorship trends. Colorectal and gastric cancers were also represented, though gastric cancerâassociated cases declined.
For lab professionals, this trend reinforces the need to adapt testing strategies, expand genomic capabilities, and collaborate closely with oncology teams as therapy-related malignancies become a more visible component of routine diagnostic workflows.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
Genetic tests make up just 5% of volume but now drive 43% of Medicare Part B lab spending, according to OIGâs latest report.
Medicare Part B spending on clinical laboratory testing rose to $8.4 billion in 2024, a 5% increase over the previous year, according to the Department of Health and Human Servicesâ Office of Inspector General (OIG). For laboratory professionals, the headline is not just rising spendingâitâs where the money is flowing.
Although genetic tests accounted for only 5% of all Part B tests performed in 2024, they represented 43% of total lab spendingâ$3.6 billion. In contrast, the far larger volume of routine chemistry, hematology, and other non-genetic tests generated $4.8 billion. Spending on non-genetic testing has generally declined since 2021, while genetic testing expenditures climbed 20% between 2023 and 2024 alone.
Utilization trends help explain the shift. The number of genetic tests paid under Part B increased 160% between 2018 and 2024, reaching 18 million tests last year. Meanwhile, non-genetic testing volume declined 12% over the same period. More enrollees are receiving at least one genetic test per year, and per-enrollee payments for those services are rising sharply.
Genetic Testing Drives Revenue Growth
In 2024, Medicare paid an average of $794 per enrollee for genetic testingâa 26% jump from 2023. By comparison, per-enrollee spending for non-genetic testing remained relatively stable at just over $200 annually. Even as overall Part B enrollment receiving clinical lab services declined 15% since 2018, spending per genetic-testing patient increased, amplifying the financial impact of molecular diagnostics on lab revenue.
OIG suggests the decline in Part B enrollees receiving lab tests may reflect migration to Medicare Advantage plans. For independent labs heavily dependent on traditional fee-for-service Part B volume, this shift adds another layer of financial pressure and underscores the need to monitor payer mix closely.
Attorney Alissa D. Fleming, a shareholder at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, told The Dark Report that federal audit risks have increased because of the OIG’s genetic test findings. The Dark Report is a sibling brand to Dark Daily.
High-Dollar Molecular Codes Dominate the Top 25
The concentration of revenue in high-priced molecular assays is intensifying. In 2024, 346 laboratories received more than $1 million in Medicare payments for genetic tests; 55 labs exceeded $10 million. The top 25 laboratory procedure codes accounted for nearly half of all Part B lab spendingâmore than $4.1 billion.
Genetic tests dominated the fastest-growing segments. CPT code 87798âused for infectious agent detection by nucleic acid when no organism-specific code existsâgenerated $443 million in 2024, a 51% increase over 2023, making it the highest-paid lab test under Part B. An epilepsy genomic panel (CPT 81419) posted a fivefold spending increase year over year. Several oncology liquid biopsy assays remain among the highest-reimbursed tests, with median payments reaching into the thousands of dollars.
Routine Testing Holds Volumeâbut Not Spending Power
In contrast, routine tests familiar to every clinical laboratoryâcomprehensive metabolic panels (80053), CBCs (85025), lipid panels (80061), thyroid testing (84443), and A1C (83036)âeither declined or remained flat in spending. Comprehensive metabolic panel spending has dropped 25% since 2018 and fell from the top spending position in 2023 to second place in 2024. These high-volume, low-margin tests continue to anchor daily lab operations but represent a shrinking share of total Medicare dollars.
Importantly, OIG notes that these shifts are not driven by changes in the Clinical Laboratory Fee Schedule, which has remained largely frozen since 2020 under provisions from the Protecting Access to Medicare Act. Instead, spending growth reflects changes in utilization, test mix, and per-enrollee costs.
For clinical laboratory leaders, the message is clear: Medicareâs lab dollars are increasingly concentrated in molecular diagnostics. That shift brings opportunityâbut also heightened regulatory scrutiny. OIGâs history of fraud alerts and audits in genetic testing suggests that compliance, documentation, and medical necessity controls will remain critical as high-complexity testing continues to expand within the Medicare population.
This article was created with the assistance of generative AI and has undergone editorial review before publishing.
A new partnership between Intermountain Health and Testmate Health aims to bring rapid, lab-quality STI testing out of the central lab and into underserved communities, addressing persistent gaps in diagnosis and follow-up care.
Testmate Health and Intermountain Health have entered a strategic partnership and investment aimed at accelerating access to rapid, low-cost molecular testing for sexually transmitted infections (STIs) across the US.
For clinical laboratory leaders, the collaboration signals a growing push to move high-quality molecular diagnostics closer to patients, particularly those belonging to underserved and high-risk populations.
STIs continue to represent a major public health challenge, with an estimated 80% of chlamydia and gonorrhea infections going undiagnosed each year. Delays in testing and treatment are especially common among college students, LGBTQ+ populations, and patients served by rural or resource-limited clinics. The two organizations say their partnership is designed to close those gaps by making accurate, lab-quality testing available outside of traditional laboratory environments.
Bringing Molecular Diagnostics Beyond the Central Lab
Under the agreement, Intermountain Health will support the deployment of Testmateâs single-use, reader-free molecular tests for Chlamydia trachomatis and Neisseria gonorrhoeae. The tests are designed to deliver results in under 30 minutes and do not require central lab infrastructure. They can be used with urine or swab samples, offering flexibility for a range of care settings.
Karen Brownell, vice president of Lab Services at Intermountain Health said, âWhen these STI tests become FDA-approved in the US, Testmateâs innovative approach to molecular diagnostics will allow us to deliver lab-quality results outside traditional lab settings, directly impacting communities that have historically lacked access to timely testing.â (Photo credit: ContactOut)
Addressing Access, Turnaround Time, and Follow-Up
Testmateâs leadership emphasized that reducing barriers to testing is central to improving outcomes. Rapid turnaround times may help clinicians initiate treatment during the same visit, reducing loss to follow-upâa persistent issue in STI management.
The organizations say combining Testmateâs physician-developed diagnostics with Intermountainâs clinical infrastructure could also lower overall healthcare costs by enabling earlier detection and treatment.
For laboratory leaders, the collaboration highlights a broader trend toward decentralized molecular testing and point-of-care strategies that complement, rather than replace, core laboratory services. As health systems look to improve access and equity while managing costs, partnerships like this one may foreshadow how labs extend their impact beyond traditional walls.
Dettwyler is set to retire at age 92 after a long career helping clinical laboratories with their coding and billing systems
When William Dettwyler, MT, began working in a clinical laboratory, Harry Truman was president of the United States and scientists had not yet discovered the structure of DNA. Now, as he approaches his 92nd birthday in March, he is finally ready to retire from a career that has spanned more than seven decades, from bench work as a medical laboratory technician (MLT) to assisting labs with their medical coding and medical billing challenges.
Along the way, one of his coding innovations helped the State of Oregon save substantial sums in its Medicaid program. He also helped many medical laboratories increase reimbursement by correcting their coding mistakes. This from someone who left school after eighth grade to help on his familyâs farm in rural Oregon.
In an exclusive interview with Dark Daily, Dettwyler discusses his long career and offered pointers for labs on improving their coding and reimbursement procedures.
Back in the 1980s, when he began his consulting work for labs, âthey were very poor at billing,â he recalled. âHospital billing staff didnât understand lab coding. Reference laboratories didnât do a good job of picking the right codes or even billing all the codes. Up until around the 1970s, hospitals didnât even have to bill individual lab procedures with CPT codes. They billed with a revenue center code for all their lab services.â
These days âpeople are much more sophisticated,â he notes. âThere are fewer coding problems compared to what it was in the 1980s and 1990s up to the 2010s.â However, he says he still has a handful of clients who call on his expertise.
âIt was not unusual to go to a large university medical center and in three days tell the CFO on my exit review that the following year their lab would bring in about a half million more in revenue, just from my coding review. But I did not reveal to them that I had only gone to the eighth grade in a little one room school and was the lone graduate in my eighth-grade class,â wrote William Dettwyler, MT (above), owner of Codus Medicus in Salem, Ore., in an article he penned for Medical Laboratory Observer. For 75 years Dettwyler worked in the clinical laboratory industry. For much of that time he helped labs all over America improve their coding and reimbursement systems. (Photo copyright: LinkedIn.)
How It All Began
Dettwyler got his first taste of lab work in the early 1950s as a teenager washing glassware for a medical laboratory technician at a local medical practice. A few years later he completed an MLT program at Oregon Institute of Technology in Klamath Falls and landed his first lab tech job at a clinic in Portland.
His entry to consulting came in the early 1970s while he was working for a medical group in Salem. âI was helping the accounting personnel with their billing and noticed that Medicaid was not paying for a common test for syphilis that I was performing,â he recalled. âI contacted Medicaid, and they told me they didnât understand laboratory procedures.â
After that, âthey started to call me frequently with laboratory questions,â he said. âIt wasnât long before they asked me to help them on a part-time basis.â He also assisted with questions related to radiology.
By 1976, Dettwyler was devoting 35 hours a week to assisting the state Medicaid agency while still working as a lab tech.
Simple Hack Ends Overpayments
One of his career highlights came around 1981, when he discovered that the agency was overpaying for some pathology and radiology procedures by as much as 200%.
âPathologists and radiologists are paid based on whether they are performing the complete procedureâthe technical component and the professional componentâor just the professional component, where they interpret the results,â he explained.
When billing for just the professional component, the physicians would add two digits to the standard code, so it might come in as 88305-26. However, the stateâs computer system could only accommodate a five-digit code, so the state was paying as if the providers had done everything.
âThe computer techs said the software couldnât handle a seven-digit number in a five-digit box, so I devised a way for the computer to read the equivalent of seven digits,â he recalled.
His solution was to modify the codes so that the last digit was an alphabetic character. Instead of billing for code 88305-26, the physicians would bill for 8830F, and the state would pay them correctly.
Around that time, Dettwyler also began assisting a Medicare office in Portland. This forced him to cut back on his work as a lab tech. But he still worked around 60 hours a week.
âFor most of my life, Iâve worked three jobs,â he said. âWork is my hobby.â He also had a large family to supportâby 1976, he and his wife had 10 kids.
Transition to Lab Consulting
In 1986, the state was facing a budget shortfall and cut its Medicaid consultants, so Dettwyler decided to seek consulting work with labs while continuing to work at the bench.
âI really liked the coding because I had very little competition,â he said. âBut I wanted to keep working in the laboratory mainly to understand the problems.â
While working for the state, Dettwyler attended coding seminars and workshops. He noticed that labs were losing revenue due to poor billing practices. âThey didnât understand all the coding complexities, so they really hungered for this kind of assistance.â
But first, he had to find clients. So he partnered with another lab tech who was offering similar consulting services.
Business picked up after Dettwyler contributed an article to the trade publication Medical Laboratory Observer about his process, which he calls âprocedure code verification and post payment analysis.â
âThat went like gangbusters,â he said. âWe started getting calls from all over the country.â
Dettwyler later split from his partner and went to work on his own.
âI would sit down with the person who was responsible for coding, usually the lab or radiology manager,â he explained. âWe would go over the chargemaster and cover every procedure to make sure the code and units were correct. When I was done, I would give them a report of what codes we changed and why we changed them.â
Beginning in 1989, he signed on as a contractor for another consultancy, Health Systems Concepts on the East Coast, where he remained until 2019.
Advice to the Current Generation
What is Dettwylerâs advice for someone who wants to follow in his footsteps and assist labs with their coding? âI wouldnât recommend it now,â he said. âThereâs less need for that kind of assistance than in the past.â
However, he does find that labs still run into problems. The greatest need, he says, is in molecular diagnostics, due to the complexity of the procedures.
In addition, labs are sometimes confused by coding for therapeutic drug monitoring, in which a doctor is gauging a patientâs reaction to a therapy versus screening for substance abuse. âThose issues are often misunderstood,â he said.
Microbiology also poses coding challenges, he noted, because of the steps required to identify the pathogen and determine antibiotic susceptibility. âIt requires quite a bit of additional coding,â he said. âSome labs donât understand that they canât just bill a code for culture and sensitivity. They have to bill for the individual portions.â
Labs that work with reference labs also have to be careful to verify codes for specific procedures. âIâll review the codes used by reference labs and, surprisingly, theyâre not always correct. Reference labs sometimes get it wrong.â
If someone does want to become a coding expert, Dettwyler suggests that âthey should first have experience as a lab tech, especially in microbiology, because of the additional coding. And they should try to work with somebody who is already doing it. Then, they should work with the billing department to learn how it operates.â
He also advises clinical laboratory managers to follow the latest developments in the field by reading lab publications such as The Dark Report. âYou have to do that to keep current,â he said.
Despite never completing high school, Dettwyler eventually received his GED and an associate degree. âBut the degrees didnât really help me,â he said. âMuch of it was on-the-job training and keeping my eyes open and listening.â
The CDC suggests that hospitals treating patients for flu symptoms perform clinical laboratory tests for avian influenza A within 24 hours. This additional testing will pinpoint the specific type of flu infecting an individual patient and help prevent further spread of the bird flu virus.
âItâs the subtyping that takes us from knowing that a virus is in the general bucket of âinfluenza Aâ to knowing more specifically whether itâs a garden-variety seasonal version of influenza A or, more rarely, a novel version of influenza A like H5N1,â CDC Principal Deputy Director Nirav Shah, MD, JD, told CNN.
According to the CDC, a panzootic of pathogenic avian H5N1 flu virus is currently affecting wild birds, poultry, dairy cows, and other animals throughout the country. There have been 67 total cases of bird flu identified in humans in the US since 2022, with 66 of those cases occurring in 2024.
The risk of humans contracting bird flu are low but is elevated among those who work closely with wild birds, poultry, and dairy cattle. The incidences of the flu virus in animals continues to increase, so CDC says it is important to identify potential bird flu cases in humans in a timely manner.
This demonstrates recognition by the CDC and the clinical laboratory profession that advances in molecular diagnostics and genetic testing now make it feasible for many hospital labs to perform these tests in-house on relevant patients. Such molecular testing is less expensive and produces a faster answer today, compared to just a few years ago.
This call for more lab tests in hospitals is also recognition of the value near-patient testing has from a public health perspective. Historically, it was regional and local public health labs that were sent specimens for testing from patients identified as having an infection that were a public health concern.
The good news is that this expands the role of hospital laboratories for all the right reasons. The downside is that hospital labs will probably see many test claims for these assays not be paid promptly by payersâor paid after unnecessary delays.
âThe system right now tells us what has already happened. What we need is to shift to a system that tells us whatâs happening in the moment. That is what we are doing today,â Nirav Shah, MD, JD (above), CDC principal deputy told CNN. Hospital and clinical laboratories will likely see an increase in orders for molecular and genetic testing for influenza A. (Photo copyright: Centers for Disease Control and Prevention.)
CDC Recommendations to Clinical Laboratories
The CDC alert also acknowledges that most individuals infected with avian flu were exposed to the virus via the handling of infected dairy cows or poultry in unprotected workplaces. There are no known cases of human-to-human transmission of the disease.
Most cases of avian flu in humans have been clinically mild and the patients quickly recover. However, on January 6, the CDC announced that an elderly patient with underlying health conditions in Louisiana who was previously hospitalized with severe avian influenza A illness had passed away. This case was the first confirmed death in the US attributed to the illness.
The CDCâs Health Advisory makes the following recommendations to clinical laboratories:
Subtype respiratory specimens that are positive for influenza A, but negative for seasonal influenza A virus subtypes, and forward those specimens to a public health laboratory within 24 hours.
Refrain from batching specimens for consolidated or bulk shipment to public health laboratories if that process could result in shipping delays.
Notify public health officials if a hospital or clinical lab does not have access to influenza A virus subtyping and arrange for a public health or commercial lab with this testing capability to perform the analysis.
Clearly link specimens to clinical information from the patient to ensure the prioritization of severely ill and ICU patients.
Immediately contact local public health authority if a positive result for influenza A (H5) virus is obtained using a laboratory developed test (LDT) or another A (H5) subtyping test to initiate time-critical actions.
The CDCâs Health Advisory also states public health laboratories should complete influenza A subtyping assays within 24 hours of receipt and report those results to the CDC, as required.
âOne of the motivators of accelerating testing [is] so that we are, again, able to faster see difference between signal and noise, given that the volume of hospitalizations is going up as expected in a rather routine flu season,â Demetre Daskalakis, MD, MPH, director of the CDCâs National Center for Immunization and Respiratory Diseases (NCIRD), told CNN.Â
Preparing for more Bird Flu in Humans
According to the CDC, approximately 100,000 Americans have been hospitalized with type-A flu this season. The agency expects another 100,000 hospitalizations due to the virus before the end of this year. CDC is tracking flu infections on a weekly basis. Data can be reviewed on its website.
Other government organizations also are developing methods intended to curb the spread of the influenza virus. The federal Department of Agriculture recently launched a national program to test for bird flu in untreated milk. And the US Department of Health and Human Services (HHS) allocated $211 million in new funding to address emerging infectious diseases.
On January 17, the HHS announced it would give $590 million to Moderna to âaccelerate the development of mRNA-based pandemic influenza vaccines and enhance mRNA platform capabilities so that the US is better prepared to respond to other emerging infectious diseases.â
âThe funding will allow us to bring the benefits of mRNA vaccine technology to bear against a wider array of emerging threats,â said HHS Assistant Secretary for Preparedness and Response Dawn OâConnell, JD, in the announcement. âmRNA technology can be faster to develop and easier to update than other vaccines making it a helpful tool to have against viruses that move fast and mutate quickly.
Hospital laboratories and public health labs should prepare for a spike in test orders for avian influenza A as this yearâs flu season progresses. As bird flu increases in animals, it increases the possibility that the disease might infect humans. Â
