Oddly, as upcoding severity levels have risen, reported higher-severity inpatient hospital stays have dropped, OIG reported
Medicare upcoding fraud is a growing problem for the federal Centers for Medicare and Medicaid Services (CMS). Now, a report from the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) suggests that the practice is increasingly occurring for high-severity inpatient hospital stays that account for the most expensive part of US healthcare.
“The [COVID-19] pandemic has placed unprecedented stress on the country’s healthcare system, making it more important than ever to ensure that Medicare dollars are spent appropriately,” the OIG report states.
The OIG website notes, “Medicare pays for many physician services using Evaluation and Management (commonly referred to as “E/M”) codes. New patient visits generally require more time than follow-up visits for established patients, and therefore E/M codes for new patients command higher reimbursement rates than E/M codes for established patients.”
The OIG describes one type of upcoding as “… an instance when [providers] provide a follow-up office visit or follow-up inpatient consultation, but bill using a higher-level E/M code as if [they] had provided a comprehensive new patient office visit or an initial inpatient consultation.
“Another example of upcoding related to E/M codes is misuse of Modifier 25,” the OIG continued. “Modifier 25 allows additional payment for a separate E/M service rendered on the same day as a procedure. Upcoding occurs if a provider uses Modifier 25 to claim payment for an E/M service when the patient care rendered was not significant, was not separately identifiable, and was not above and beyond the care usually associated with the procedure.”
How OIG Conducted the Study of Hospital Coding Practices
To perform its research, the OIG analyzed Medicare Part A claims for hospital stays for the six-year period from fiscal year (FY) 2014 through FY 2019. The OIG identified trends in billing and payments for inpatient hospital stays at the highest severity levels, as determined by the Medicare Severity Diagnosis Related Group (MS-DRG).
The OIG investigation revealed that the number of hospital stays billed at the highest severity level increased almost 20% between 2014 and 2019, while the number of stays billed at other severity levels decreased. These expenditures accounted for nearly half of all Medicare spending on inpatient hospital stays, the OIG reported.
According to the OIG report, “Medicare pays hospitals more for beneficiaries in MS-DRGs with higher severity levels because they are typically more costly to treat.” The graphic above taken from the OIG report illustrates “how the presence of complications can affect Medicare payment for three beneficiaries with the same principal diagnosis.” (Graphic copyright: Federal Office of Inspector General Department of Health and Human Services.)
As Severity Levels Went Up, Inpatient Length of Stays Went Down
Interestingly, the average length of inpatient stays at the highest severity level decreased, and the average length of hospital stays overall remained largely the same, decreasing by just 0.1 days. In addition, the total number of inpatient hospital stays decreased by 5%.
The OIG report noted that “the increase in the number of stays billed at the highest severity level implies that beneficiaries were sicker overall. However, the decrease in the average length of stays at the highest severity level potentially undermines that idea because it is not consistent with sicker beneficiaries. Length of stay generally has a positive relationship to severity of stay; sicker beneficiaries stay in the hospital longer.”
The OIG confirmed that in FY 2019, Medicare spent $109.8 billion for 8.7 million hospital stays. Approximately 3.5 million (or 40%) of those stays were billed at the highest severity level, as determined by the MS-DRG. In addition, nearly half of the $109.8 billion spent, or $54.6 billion, was for stays billed at the highest severity level and Medicare paid an average of $15,500 per stay at that level.
The OIG report states that “stays at the highest severity level are vulnerable to inappropriate billing practices, such as upcoding—the practice of billing at a level that is higher than warranted. Specifically, nearly a third of these stays lasted a particularly short amount of time and over half of the stays billed at the highest severity level had only one diagnosis qualifying them for payment at that level. Further, hospitals varied significantly in their billing of these stays, with some billing much differently than most.”
The OIG study also found that over half of the inpatient stays billed at the highest severity level achieved that level due to only one diagnosis. According to the OIG, the severity of an inpatient stay depends on a patient’s secondary diagnosis and it only takes one secondary diagnosis to propel a patient into the highest severity level. The OIG determined that if the diagnosis was inaccurate or inappropriate, higher payments would not be warranted.
OIG Recommends CMS Conduct Targeted Reviews
The report found that the most frequently billed MS-DRG in FY 2019 was septicemia or severe sepsis and that hospitals billed for 581,000 of these stays, for which Medicare paid $7.4 billion. In addition, kidney and urinary tract infections, pneumonia, and renal failure were among the most common conditions to have a complication that led to a high severity classification.
In its report, the OIG recommended more oversight from CMS to ensure that Medicare dollars are spent appropriately. The OIG also suggests that CMS conduct targeted reviews of MS-DRGs and hospital stays that are vulnerable to upcoding, as well as the hospitals that frequently bill them.
Clinical Laboratories Are Forewarned
Medicare audits continue to be more detailed and rigorous and all healthcare providers—including clinical laboratories and anatomic pathology groups—should be prepared to present all necessary documentation to support claims if and when they are audited.
Improvements in software, machine learning, and artificial intelligence (AI) give Medicare officials and the OIG powerful tools to spot questionable provider billing. This includes medical laboratories whose billing patterns could arouse suspicions and trigger audits.
Upcoding is a long-standing problem for the Medicare program. What is changing is that federal officials now have better tools and resources to use in identifying patterns of upcoding that fall outside accepted parameters.
By mining results of unrelated blood tests, the CIRRUS algorithm can inform doctors and patients earlier than usual of liver disease
For years Dark Daily and its sister publication The Dark Report have predicted that the same type of analytical software used on Wall Street to analyze bundles of debt, such as car loans, mortgages, and installment loans, would eventually find application in healthcare and clinical laboratory medicine. Now, researchers at the University of Southampton in England have developed just such an analytical tool.
The UK researchers call their algorithm CIRRUS, which stands for CIRRhosis Using Standard tests. It can, they say, accurately predict if a patient has cirrhosis of the liver at a much earlier stage than usual and produce information that is clinically actionable, using results from several common, routinely-ordered medical laboratory tests.
The University of Southampton scientists published their findings in BMJ Open.
Currently, the leading edge for this in clinical laboratory medicine is analysis of digital pathology images using image analysis tools and artificial intelligence (AI). However, CIRRUS is an example that analytical software is advancing in its ability to mine data from a number of clinically-unrelated lab tests on a patient and identify a health condition that might otherwise remain unknown.
The UK researchers designed the CIRRUS algorithm using routine clinical laboratory blood tests often requested in general practice to identify individuals at risk of advanced liver disease. These tests include:
“More than 80% of liver cirrhosis deaths are linked to alcohol or obesity and are potentially preventable,” noted Nick Sheron, MD, FRCP, Head of Population Hepatology at University of Southampton, and lead author of the study, in a press release. “However, the process of developing liver cirrhosis is silent and often completely unsuspected by GPs [general practitioners]. In 90% of these patients, the liver blood test that is performed is normal, and so liver disease is often excluded.
“This new CIRRUS algorithm can find a fingerprint for cirrhosis in the common blood tests done routinely by GPs,” he continued. “In most cases the data needed to find these patients already exists and we could give patients the information they need to change their lifestyle. Even at this late stage, if people address the cause by stopping drinking alcohol or reducing their weight, the liver can still recover.”
Mining Clinical Laboratory Blood Test Results
To perform the study, the research team analyzed data on blood test results for nearly 600,000 patients. Unlike most diagnostic liver algorithms, the CIRRUS model was created using a dataset comprised of patients from both primary and secondary care without the main intent of preselecting for liver disease. This renders it better suited for detecting liver disease outside a secondary care hepatology environment.
“Whilst we are all preoccupied with the coronavirus pandemic we must not lose sight of other potentially preventable causes of death and serious illness,” said Michael Moore, BM, BS, MRCP, FRCGP, Professor of Primary Health Care Research and Head of Academic Unit Primary Care and Population Sciences at University of Southampton, in the press release. Professor Moore co-authored the CIRRUS study.
“This test using routine blood test data available, gives us the opportunity to pick up serious liver disease earlier, which might prevent future emergency admission to hospital and serious ill health,” he said.
Cirrhosis (shown above in a trichrome stained micrograph) is a condition in which the liver is scarred and permanently damaged. As the condition progresses, more scar tissue replaces healthy liver tissue. This accumulated scar tissue prevents the liver from doing its primary job of regulating chemical levels in the blood and excreting bile, a substance which helps eliminate toxins from the body and breaks down fats during digestion. As cirrhosis worsens, the liver begins to fail. (Photo copyright: Wikipedia.)
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), cirrhosis is most common in adults ages 45 to 54 and about 1 in 400 adults in the US live with the disease. However, the actual number may be much higher as many people are not aware they have cirrhosis, because they do not experience symptoms until the liver is badly damaged.
The NIDDK reports complications from cirrhosis include:
Portal Hypertension, a condition where scar tissue partially blocks the normal flow of blood through the liver,
“Liver cirrhosis is a silent killer. The tests used most by GPs are not picking up the right people and too many people are dying preventable deaths. We looked at half a million anonymous records and the data we needed to run CIRRUS was already there in 96% of the people who went on to have a first liver admission,” stated Sheron in the press release. “With just a small change in the way we handle this data it should be possible to intervene in time to prevent many of these unnecessary deaths.”
“Alcohol-related liver diseases are far and away the most significant cause of alcohol-specific deaths, yet currently the vast majority of people find out that their liver is diseased way too late,” said Richard Piper, PhD, Chief Executive of Alcohol Change UK, a British charity and campaign group dedicated to reducing harm caused by alcohol abuse. “What is needed is a reliable means of alerting doctors and their patients to potential liver disease as early as possible. The CIRRUS process shows real promise, and we want to see it further developed, tested and implemented, to help save hundreds of thousands, if not millions, of lives.”
CIRRUS is a true milestone in the development of computer-assisted healthcare diagnostics. It will need more research, but the University of Southampton study shows that analytical software tools can mine clinical laboratory test results that were ordered for unrelated diagnostics and identify existing health conditions that might otherwise remain hidden to the patient’s physicians.
Might this be a sign that AI platforms like Watson still cannot diagnose the wide range of patients’ conditions as accurately as a board-certified clinical pathologist?
Computer technology evolves so quickly, products often become obsolete before fulfilling their expected potential. Such, apparently, is the case with Watson, the genius artificial intelligence (AI) brainchild of International Business Machines Corp. (IBM) which was going to revolutionize how healthcare providers diagnose disease. In some areas of healthcare, such as analyzing MRIs and X-rays, AI has been a boon. But from a business perspective, Watson has failed to turn a profit for IBM, so it has to go.
In February, The Wall Street Journal (WSJ) reported that IBM is looking to sell its Watson Health unit because it is not profitable, despite bringing in $1 billion annually in revenue. The sale of Watson Health, the article states, would be aligned with IBM’s goal of streamlining the company and focusing its energies on cloud computing and other AI functions. Because one goal of the Watson project was to give physicians a tool to help them diagnose patients more accurately and faster, the problems that prevented Watson from achieving that goal should be of interest to pathologists and clinical laboratory managers, who daily are on the front lines of helping doctors diagnose the most challenging cases.
In a follow-up article, titled, “Potential IBM Watson Health Sale Puts Focus on Data Challenges,” the WSJ wrote, “… some experts found that it can be difficult to apply AI to treating complex medical conditions. Having access to data that represents patient populations broadly has been a challenge, experts told the Journal, and gaps in knowledge about complex diseases may not be fully captured in clinical databases.”
“I believe that we’re many years away from AI products that really positively impact clinical care for many patients,” Bob Kocher, Partner at Venrock, a venture-capital firm that invests in healthcare IT and related services, told the WSJ.
IBM Watson was promoted as a major resource to help improve medical care and support doctors in making more accurate diagnoses. However, in “IBM’s Retreat from Watson Highlights Broader AI Struggles in Health,” the WSJ reported that “IBM spent several billion dollars on acquisitions to build up Watson [Health] … a unit whose marquee product was supposed to help doctors diagnose and cure cancer … A decade later, reality has fallen short of that promise.”
IBM initially created Watson (above center) to be an AI tool capable of a wide variety of applications, starting with answering questions. In January 2011, Watson made headlines when it defeated previous Jeopardy champions Ken Jennings (left) and Brad Rutter (right) on the popular television game show.After its triumph, IBM announced it would transition Watson for use in medical applications and promoted it as a major resource to help improve medical care and support healthcare professionals in making more precise diagnoses. The company called its new division IBM Watson Health and stated that massive data sets would be the key to accomplish its healthcare mission. That same year, The Dark Report had an IBM executive do a presentation about Watson Health at the Executive War College on Laboratory and Pathology Management. (Photo copyright: CBS News.)
Watson’s Successes and Failures in Healthcare
During the years following Watson’s Jeopardy win, Watson Health made some positive advances in the fields of healthcare data analytics, performance measurements, clinical trial recruitment, and healthcare information technology (HIT).
However, Watson Health also experienced some high-profile failures as well. One such failure involved a collaboration with MD Anderson Cancer Center, established in 2013, to help the health systems’ oncologists develop new tools to benefit cancer patients. MD Anderson ended the relationship in 2018 after spending more than $60 million on the project, citing “multiple examples of unsafe and incorrect treatment recommendations,” made by the Watson supercomputer, Healthcare IT News reported.
Watson Health later readjusted the development and sales of its AI drug discovery tools and altered its marketing strategy amid reports of disappointing sales and skepticism surrounding machine learning for medical applications.
Underestimating the Challenge of AI in Healthcare
Since its inception, Watson Health has achieved substantial growth, mainly through a series of acquisitions. Those targeted acquisitions include:
Merge Healthcare, a healthcare imaging software company that was purchased for $1 billion in 2015,
Phytel, a health management software company that was purchased for an undisclosed amount in 2015,
Explorys, a healthcare analytics company that was purchased for an undisclosed amount in 2015, and
Truven Health Analytics, a provider of cloud-based healthcare data, analytics, and insights that was purchased for $2.6 billion in 2016.
“IBM’s Watson Health business came together as a result of several acquisitions,” said Paddy Padmanabhan, founder and CEO of Damo Consulting, a firm that provides digital transformation strategy and advisory services for healthcare organizations. “The decision to sell the business may also have to do with the performance of those units on top of the core Watson platform’s struggles,” he told Healthcare IT News.
It should be noted that these acquisitions involved companies that already had a product in the market which was generating revenue. So, the proposed sale of Watson Health includes not just the original Watson AI product, but the other businesses that IBM put into its Watson Health business division.
Padmanabhan noted that there are many challenges for AI in healthcare and that “historical data is at best a limited guide to the future when diagnosing and treating complex conditions.” He pointed to the failure with MD Anderson (in the use of Watson Health as a resource or tool for diagnosing cancer) was a setback for both IBM and the use of AI in healthcare. However, Padmanabhan is optimistic regarding the future use of AI in healthcare.
“To use an oft-quoted analogy, AI’s performance in healthcare right now is more akin to that of the hedgehog than the fox. The hedgehog can solve for one problem at a time, especially when the problem follows familiar patterns discerned in narrow datasets,” he told Healthcare IT News. “The success stories in healthcare have been in specific areas such as sepsis and readmissions. Watson’s efforts to apply AI in areas such as cancer care may have underestimated the nuances of the challenge.”
Other experts agree that IBM was overly ambitious and overreached with Watson Health and ended up over-promising and under-delivering.
“IBM’s initial approach misfired due to how the solution AI was trained and developed,” Dan Olds, Principal Analyst with Gabriel Consulting Group, told EnterpriseAI. “It didn’t conform well to how doctors work in the real world and didn’t learn from its experiences with real doctors. It was primarily learning from synthetic cases, not real-life cases.”
Was Watson Already Obsolete?
Another issue with Watson was that IBM’s marketing campaign may have exceeded the product’s design capabilities. When Watson was developed, it was built with AI and information technologies (IT) that were already outdated and behind the newest generation of those technologies, noted Tech Republic.
“There were genuine AI innovation triggers at Watson Health in natural language processing and generation, knowledge extraction and management, and similarity analytics,” Jeff Cribbs, Research Vice President at Gartner Research, told Tech Republic. “The hype got ahead of the engineering, as the hype cycle says it almost always will, and some of those struggles became apparent.”
Can Artificial Intelligence Fulfill its Potential in Healthcare?
The fact that IBM is contemplating the sale of Watson Health is another illustration of how difficult it can be to navigate the healthcare industry in the US. It is probable that someday AI could make healthcare diagnostics more accurate and reduce overall costs, however, data challenges still exist and more research and exploration will be needed for AI to fulfill its potential.
“Today’s AI systems are great in beating you at chess or Jeopardy,” Kumar Srinivas, Chief Technology Officer, Health Plans, at NTT DATA Services told Forbes. “But there are major challenges when addressing practical clinical issues that need a bit of explanation as to ‘why.’ Doctors aren’t going to defer to AI-decisions or respond clinically to a list of potential cancer cases if it’s generated from a black box.”
And perhaps that is the biggest challenge of all. For doctors to entrust their patients’ lives to a supercomputer, it better be as good as the hype. But can AI in healthcare ever accomplish that feat?
“AI can work incredibly well when it’s applied to specific use cases,” gastroenterologist Nirav R. Shah, MD, Chief Medical Officer at Sharecare, told Forbes. “With regards to cancer, we’re talking about a constellation of thousands of diseases, even if the focus is on one type of cancer. What we call ‘breast cancer,’ for example, can be caused by many different underlying genetic mutations and shouldn’t really be lumped together under one heading. AI can work well when there is uniformity and large data sets around a simple correlation or association. By having many data points around a single question, neural networks can ‘learn.’ With cancer, we’re breaking several of these principles.”
So, in deciding to divest itself of Watson Health, IBM may simply be as prescient now as it was when it first embraced the concept of AI in healthcare. The tech giant may foresee that AI will likely never replace the human mind of a trained healthcare diagnostician.
If this proves true—at least for several more years—then board-certified clinical pathologists can continue to justifiably refer to themselves as “the doctor’s doctor” because of their skills in diagnosing difficult-to-diagnose patients, and because of their knowledge of which clinical laboratory tests to order and how to interpret those test results.
Since the early 1980s, UBC’s CMPT program, led by medical microbiologist Michael Noble, MD, has provided external quality assessment (EQA) for clinical microbiology and water testing laboratories. This includes providing biological samples related to:
“Typical of every jurisdiction in North America and probably around the world, BCCDC got swamped beyond swamped,” said Noble, the Clinical Microbiology Proficiency Testing (CMPT) program’s first and current Chair, in an exclusive interview with Dark Daily. “The increase was 10-fold, and they were unable to provide all the services they wanted to do. And since I was already running a proficiency testing program across the province, they asked if I would provide that service for COVID-19 for laboratories that were doing the testing.”
Michael Noble, MD (above), is Professor Emeritus (active) in UBC’s Department of Pathology and Laboratory Medicine and Chair of the Program Office for Laboratory Quality Management (POLQM). He began his career as a medical microbiologist but soon focused on laboratory quality management. Within the Department of Pathology and Laboratory Medicine, Noble co-developed the Clinical Microbiology Proficiency Testing (CMPT) program in 1983, a program he still chairs but will soon pass on to a new leader. (Photo copyright: University of British Columbia.)
CMPT’s Proficiency Testing Serves Labs Worldwide
UBC’s CMPT external quality assessment (EQA) program serves all medical laboratories in British Columbia, as well as other labs in Canada, Europe, South America, and the Caribbean. Just over 200 laboratories currently participate in the program. More labs participated in past years, before lab consolidation affected CMPT and other programs as well, Noble said.
CMPT’s proficiency testing ensures that participant laboratories that have been provided with simulated samples can perform tests at the “level of quality and competence required,” notes UBC’s CMPT website.
“Samples are complex, highly realistic, and clinically relevant. CMPT samples contain host elements as well as targeted pathogens,” Noble explained on his blog, “Making Medical Laboratory Quality Relevant.”
COVID-19 Brings Non-Traditional ‘Laboratories’ to CMPT’s Proficiency Testing Program
UBC’s proficiency testing for SARS-CoV-2, the coronavirus that causes the COVID-19 infection, differs from other CMPT programs. That’s due to new participants that entered the laboratory testing program during the COVID-19 pandemic that are performing COVID-19 testing in non-traditional locations, Noble stated.
“In our proficiency programs, we had mainly been dealing with traditional clinical laboratories,” Noble explained. “But now, we find people doing COVID-19 testing—even though defined as medical laboratories—who are working in airports, or in tourism, or the movie industry, or forestry. They may never have worked in an actual clinical laboratory. So, it’s a very different style of proficiency testing. There has been a lot of handholding, teleconferences, discussions, and one-on-ones with that group,” Noble said.
Participant laboratories receive viral material that “simulates typical samples.” They need to demonstrate proficiency by performing the test and reporting it as positive, negative, or inconclusive.
“Our product is derived from a pure culture of a single strain of SARS-CoV-2, and it appears to be effective for all targets,” Noble stated.
Detecting COVID-19 by Gargling and Rinsing
UBC’s program typically offers simulated sampling for detection of SARS-CoV-2 in nasopharyngeal swabs. However, the BC Center for Disease Control’s (BCCDC) mouth rinse and gargle sample collection for diagnosis of COVID-19 also is available and widely used in Canada, Noble said.
In his career, Noble transitioned from medical microbiology to qualitology, which he describes as “the study of quality in the medical laboratory.”
In stressing the importance of laboratory quality testing, Noble describes the possibility of laboratory testing going awry and leading to a microbiological public health emergency.
“What happens if there’s a stool sample, and someone misses the presence of Campylobacteriosis in the stool? What happens if that’s part of a foodborne disease and there’s an outbreak in the city and samples are being missed? How many people will be impacted as a result of that error?” he asked.
University of British Columbia Endows a Chair for Laboratory Quality Management
Noble says UBC’s Program Office for Laboratory Quality Management (POLQM) has involved organizations worldwide and certified more than 500 people.
“The impact they have over their laboratories has been huge. Maybe that would have happened without us. But we were a part of that. And our impact is not one laboratory or one city or one province but widespread, and that’s a real and enriching experience to have,” he said.
But now it is time for him to move on. Noble secured (through UBC), a benefactor to establish the endowed Chair for Laboratory Quality Management. The family of the late Donald B. Rix, MD, a Canadian pathologist and philanthropist, gave $1.5 million (matched by the university) to create the Associate Professor (Grant Tenure) Donald B. Rix Professorship in Laboratory Quality at UBC, Department of Pathology and Laboratory Medicine.
Long-serving pathologists and medical laboratory professionals may remember that Rix was the founder and chair of MDS Metro Laboratory Services (now known as LifeLabs Medical Laboratory Services). It grew into the largest private medical laboratory in Western Canada.
Referring to this endowed new Chair for Laboratory Quality Management, Noble said, “I think this is the first named position of laboratory quality in North America.” UBC has commenced reviewing applications for the position, which is expected to be effective in January 2022. Pathologists and clinical laboratory scientists with appropriate qualifications and interest in this position should contact Dr. Noble’s office at the University of British Columbia Faculty of Medicine.
VCU scientists used the technique to measure mutations associated with acute myeloid leukemia, potentially offering an attractive alternative to DNA sequencing
More accurate but less-costly cancer diagnostics are the Holy Grail of cancer research. Now, research scientists at Virginia Commonwealth University (VCU) say they have developed a clinical laboratory diagnostic technique that could be far cheaper and more capable than standard DNA sequencing in diagnosing some diseases. Their method combines digital polymerase chain reaction (dPCR) technology with high-speed atomic force microscopy (HS-AFM) to generate nanoscale-resolution images of DNA.
The technique allows the researchers to measure polymorphisms—variations in gene lengths—that are associated with many cancers and neurological diseases. The VCU scientists say the new technique costs less than $1 to scan each dPCR reaction.
“We chose to focus on FLT3 mutations because they are difficult to [diagnose], and the standard assay is limited in capability,” said physicist Jason Reed, PhD, Assistant Professor in the Virginia Commonwealth University Department of Physics, in a VCU press release.
Reed is an expert in nanotechnology as it relates to biology and medicine. He led a team that included other researchers in VCU’s physics department as well as physicians from VCU Massey Cancer Center and the Department of Internal Medicine at VCU School of Medicine.
“The technology needed to detect DNA sequence rearrangements is expensive and limited in availability, yet medicine increasingly relies on the information it provides to accurately diagnose and treat cancers and many other diseases,” said Jason Reed, PhD (above center, with Andrey Mikheikin, PhD, on left and Sean Koebley, PhD, on right), in a press release from Virginia Commonwealth University (VCU). “We’ve developed a system that combines a routine laboratory process with an inexpensive yet powerful atomic microscope that provides many benefits over standard DNA sequencing for this application, at a fraction of the cost.” (Photo copyright: Virginia Commonwealth University.)
Validating the Clinical Laboratory Test
The physicists worked with two VCU physicians—hematologist/oncologist Amir Toor, MD, and hematopathologist Alden Chesney, MD—to compare the imaging technique to the LeukoStrat CDx FLT3 Mutation Assay, which they described as the “current gold standard test” for diagnosing FLT3 gene mutations.
The researchers said their technique matched the results of the LeukoStrat test in diagnosing the mutations. But unlike that test, the new technique also can measure variant allele frequency (VAL). This “can show whether the mutation is inherited and allows the detection of mutations that could potentially be missed by the current test,” states the VCU press release.
“We plan to continue developing and testing this technology in other diseases involving DNA structural mutations,” Reed said. “We hope it can be a powerful and cost-effective tool for doctors around the world treating cancer and other devastating diseases driven by DNA mutations.”
“In our approach we first used digital PCR, in which a mixed sample is diluted to less than one target molecule per aliquot and the aliquots are amplified to yield homogeneous populations of amplicons,” he said. “Then, we deposited each population onto an atomically-flat partitioned surface.”
The VCU researchers “scanned each partition with high-speed atomic force microscopy, in which an extremely sharp tip is rastered across the surface, returning a 3D map of the surface with nanoscale resolution,” he said. “We wrote code that traced the length of each imaged DNA molecule, and the distribution of lengths was used to determine whether the aliquot was a wild type [unmutated] or variant.”
In Diagnostics World, Reed said the method “doesn’t really have any more complexity than a PCR assay itself. It can easily be done by most lab technicians.”
Earlier Research
A VCU press release from 2017 noted that Reed’s research team had developed technology that uses optical lasers (similar to those in a DVD player) to accelerate the scanning. The researchers previously published a study about the technique in Nature Communications, and a patent is currently pending.
“DNA sequencing is a powerful tool, but it is still quite expensive and has several technological and functional limitations that make it difficult to map large areas of the genome efficiently and accurately,” Reed said in the 2017 VCU press release. “Our approach bridges the gap between DNA sequencing and other physical mapping techniques that lack resolution. It can be used as a stand-alone method or it can complement DNA sequencing by reducing complexity and error when piecing together the small bits of genome analyzed during the sequencing process.”
Using CRISPR technology, the team also developed what they described as a “chemical barcoding solution,” placing markers on DNA molecules to identify genetic mutations.
New DNA Clinical Laboratory Testing?
Cancer diagnostics are constantly evolving and improving. It is not clear how long it will be before VCU’s new technique will reach clinical laboratories that perform DNA testing, if at all. But VCU’s new technique is intriguing, and should it prove viable for clinical diagnostic use it could revolutionize cancer diagnosis. It is a development worth watching.
Physician use of genetic tests continues to grow at robust rates, even during the pandemic, but uncertainty about managed care reimbursement hangs over the market
It may surprise many pathologists and clinical laboratory managers to learn that the market for genetic testing is robust and growing swiftly, even in the midst of the COVID-19 pandemic. At the same time, the explosion in both the number of unique genetic tests available to physicians, and the willingness of doctors to order genetic tests for their patients, are creating major challenges for both government and private payers.
Moreover, how payers are attempting to gain control over this boom in genetic testing is creating serious problems for genetic testing companies seeking reimbursement for their test claims. This is because health insurers are taking aggressive steps to control their spending on genetic tests. Some of those steps include:
Prior-authorization requirements for an ever-larger number of genetic tests.
Reducing the prices paid for high-cost genetic tests.
Tough audits that use sampling and extrapolation and produce sizeable recoupment demands.
Unexpected Developments in Genetic Test Marketplace
These are reasons why clinical laboratories need to fully understand the state of the genetic testing market. Physicians are receptive to ordering genetic tests that will improve the care they provide their patients. But health insurers want better control over the unplanned and substantial increases in the total amount of money they pay out for the surging number of genetic test claims.
Collectively, these developments confront genetic testing companies with a mix of good news and bad news. The good news is that more physicians are using genetic tests in their daily medical practice. The bad news is that many payers are erecting ever-more restrictive hurdles that labs must overcome when submitting genetic test claims and seeking adequate payment.
Strategic Insights into What’s Changing with Genetic Testing
This webinar will be one of the most important strategic assessments of genetic testing presented to the clinical laboratory and diagnostics industries since the COVID-19 pandemic began last March. Your presenters are recognized thought-leaders in the genetic testing and laboratory medicine industries. Speaking in order are:
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC, Los Angeles: An expert in how Medicare and private payers establish coverage guidelines and prices for new genetic tests, Dr. Quinn will explain the key differences in how private payers are managing genetic test utilization and payment, compare to the federal Medicare program.
Heather Agostinelli, Asst. Vice President, Strategic Revenue Operations, XIFIN Inc., San Diego: Heather will provide a detailed perspective on the daily actions by payers as they process claims and issue payment for genetic tests. She will also present recommendations for how labs can optimize the number of clean genetic test claims, thus helping shorten payment times in ways that improve cash flow.
Rob Metcalf, CEO, Concert Genetics, Nashville, Tenn.: He will discuss the scope and scale of the explosion in the number of genetic test claims by sharing data, charts, and analyses usually only available to clients.
Your Chair and Moderator will be Robert L. Michel, Editor-in-Chief of The Dark Report.
The purpose of the upcoming webinar includes helping attendees with the following and more:
Learn why payers must now deal with more than 1,000 new genetic testing products launching every month and how that complicates claims processing.
Understand how the variation in CPT coding by different genetic testing labs complicates claims processing by payers.
Learn why “benefit investigation” is already a huge factor as consumers seek the lab with the cheapest genetic test price before they agree to be tested.
Master the art of working with prior authorization programs and know why having documents prior to authorization still does not necessarily mean the payer will reimburse for a genetic test claim.
Understand Medicare’s policy changes at the national level for genetic tests.
Know the core elements of the Medicare MolDx program that gov-erns genetic test claims across 28 states.
Valuable Information for Financial Analysis, Managed Care Executives
In addition to bringing clinical pathologists and directors/managers of clinical laboratories up to date on the genetic testing marketplace, this webinar will provide valuable insights into financial analysts’ tracking of genetic testing companies, managed care executives’ handling of genetic testing claims, genetic counselors, and others involved in managing clinical service lines that utilize genetic tests in patient care.
