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New Research Suggests Clinical Laboratory Blood Tests Could Fill A Void in Alzheimer’s Disease Diagnoses

Studies presented at the Alzheimer’s Association International Conference point to the p-tau217 protein as an especially useful biomarker

Researchers disclosed a potentially useful biomarker for Alzheimer’s Disease at a major conference this summer. The good news for clinical laboratories is that the biomarker is found in blood. If further research confirms these early findings, medical laboratories could one day have a diagnostic test for this condition.

That possibility emerged from the Alzheimer’s Association International Conference (AAIC), which was held online July 27-31. Researchers presented findings from multiple studies that suggested blood/plasma levels of a protein known as phospho-tau217 (p-tau217) can indicate brain anomalies associated with Alzheimer’s.“Changes in brain proteins amyloid and tau, and their formation into clumps known as plaques and tangles, respectively, are defining physical features of Alzheimer’s disease in the brain,” states an AAIC press release. “Buildup of tau tangles is thought to correlate closely with cognitive decline. In these newly reported results, blood/plasma levels of p-tau217, one of the forms of tau found in tangles, also seem to correlate closely with buildup of amyloid.”

At present, “there is no single diagnostic test that can determine if a person has Alzheimer’s disease,” the association states on its website. Clinicians will typically review a patient’s medical history and conduct tests to evaluate memory and other everyday thinking skills. That may help determine that an individual has dementia, but not necessarily that Alzheimer’s is the cause.

“Currently, the brain changes that occur before Alzheimer’s dementia symptoms appear can only be reliably assessed by positron-emission tomography (PET) scans, and from measuring amyloid and tau proteins in [cerebrospinal] fluid (CSF),” the association states. “These methods are expensive and invasive. And, too often, they are unavailable because they are not covered by insurance or difficult to access, or both.”

In the AAIC press release, Alzheimer’s Association Chief Science Officer Maria C. Carrillo, PhD, said that a clinical laboratory blood test “would fill an urgent need for simple, inexpensive, non-invasive and easily available diagnostic tools for Alzheimer’s.

“New testing technologies could also support drug development in many ways,” she added. “For example, by helping identify the right people for clinical trials, and by tracking the impact of therapies being tested. The possibility of early detection and being able to intervene with a treatment before significant damage to the brain from Alzheimer’s disease would be game changing for individuals, families, and our healthcare system.”

However, she cautioned, “these are early results, and we do not yet know how long it will be until these tests are available for clinical use. They need to be tested in long-term, large-scale studies, such as Alzheimer’s clinical trials.”

Eli Lilly Clinical Laboratory Alzheimer’s Test

In one study presented at the conference, titled, “Discriminative Accuracy of Plasma Phospho-tau217 for Alzheimer Disease vs Other Neurodegenerative Disorders,” researchers evaluated an experimental p-tau217 medical laboratory test developed by Eli Lilly. They published their research in JAMA Network.

The study, led by Oskar Hansson, MD, of Lund University in Sweden, included 1,402 participants. About half of these were enrolled in BioFINDER-2, an ongoing dementia study in Sweden. In this group, researchers were most interested in the test’s ability to distinguish Alzheimer’s from other neurodegenerative disorders that cause dementia.

Diagnostic accuracy was between 89% and 98%, the researchers reported, which was similar to the performance of PET imaging and CSF tests. P-tau217 was more accurate than magnetic resonance imaging (MRI) as well as other biomarkers, such as p-tau181.

Oskar-Hansson-PhD-Lund-University-400w@72ppi
“Today the majority of individuals with Alzheimer’s disease around the world do not get a timely diagnosis, which results in suboptimal symptomatic treatment and care,” Oskar Hansson, MD, said in an Eli Lilly news release. “With rising prevalence of Alzheimer’s disease, more patients will be evaluated in primary care and other clinics where CSF and PET biomarkers are not available. Blood-based biomarkers, like plasma p-tau217, together with digital tools for checking memory performance, such as smartphone-based apps, can considerably improve the diagnostic work-up of Alzheimer’s disease patients in such clinics.” (Photo copyright: Alzheimer’s Fund.)

Another cohort consisted of 81 participants in the Brain and Body Donation Program at Banner Sun Health Research Institute in Sun City, Ariz. In this program, elderly volunteers submit to periodic clinical assessments and agree to donate their organs and tissue for study after they die.

Here, the researchers’ primary goal was to determine the test’s ability to distinguish between individuals with and without Alzheimer’s. Researchers ran the p-tau217 test on plasma samples collected within 2.9 years of death and compared the results to postmortem examinations of the brain tissue. Accuracy was 89% in individuals with amyloid plaques and tangles, and 98% in individuals with plaques and more extensive tangles.

The third cohort consisted of 622 members of a large extended family in Colombia whose members share a genetic mutation that makes them susceptible to early-onset Alzheimer’s, The New York Times reported. Among the members, 365 were carriers of the mutation. In this group, levels of plasma p-tau217 increased by age, and “a significant difference from noncarriers was seen at age 24.9 years,” the researchers wrote in Jama Network. That’s about 20 years before the median age when mild cognitive impairment typically begins to appear in carriers.

Other Alzheimer Biomarker Studies Presented at AAIC

Suzanne Schindler, MD, PhD, a neurologist and instructor in the Department of Neurology at the Washington University School of Medicine (WUSM) in St. Louis, presented results of an Alzheimer’s Disease (AD) study that used mass spectrometry to analyze amyloid and p-tau variants in blood samples collected from participants. The researchers compared these with CSF and PET results and found that some of the of p-tau isoforms, especially p-tau217, had a strong concordance.

“These findings indicate that blood plasma Aβ and p-tau measures are highly precise biomarkers of brain amyloidosis, tauopathy, and can identify stages of clinical and preclinical AD,” stated an AAIC press release on the studies.

The WUSM researches launched the effort to develop and validate Alzheimer’s blood biomarkers called the Study to Evaluate Amyloid in Blood and Imaging Related to Dementia (SEABIRD) in April 2019. It runs through August 2023 and will seek to enroll more than 1,100 participants in the St. Louis area.

Another study presented at the conference compared the performance of p-tau217 and p-tau181 in distinguishing between Alzheimer’s and Frontotemporal Lobar Degeneration (FTLD), another condition that causes dementia. Study author Elisabeth Thijssen, MSc, of the UC San Francisco Memory and Aging Center reported that both biomarkers could be useful in differential diagnosis, but that p-tau217 was “potentially superior” for predicting a tau positive PET scan result.

For decades, physicians have wanted a diagnostic test for Alzheimer’s Disease that could identify this condition early in its development. This would allow the patient and the family to make important decisions before the onset of severe symptoms. Such a clinical laboratory test would be ordered frequently and thus would be a new source of revenue for medical laboratories.

—Stephen Beale

Related Information:

How is Alzheimer’s Disease Diagnosed?

Alzheimer’s Diagnosis and Treatment

Diagnosing Alzheimer’s: How Alzheimer’s is Diagnosed

New Alzheimer’s Disease Blood Test Could Enable Early Diagnosis and Advance Understanding of How Disease Impacts Those Living with It

Lilly’s p-tau217 Blood Test Shows High Accuracy in Diagnosis of Alzheimer’s Disease in Data Published in JAMA

P-Tau217 May Detect Alzheimer Disease, Brain Amyloidosis, Tauopathy

New Blood Test Shows Great Promise in The Diagnosis of Alzheimer’s Disease

‘Amazing, Isn’t It?’ Long-Sought Blood Test for Alzheimer’s in Reach

Scientists Get Closer to Blood Test for Alzheimer’s Disease

Discriminative Accuracy of Plasma Phospho-tau217 for Alzheimer Disease vs Other Neurodegenerative Disorders

Clinical Laboratory Test for Alzheimer’s Disease Gets Ever Closer to Reality

Scientists worldwide engaged in research to develop a biomarker for dementia are predicting success, though some say additional research will be needed

Could a blood test for Alzheimer’s disease soon be on clinical laboratory test menus nationwide? Perhaps so. A recent Associated Press (AP) article that was picked up by NBC News and other healthcare publications reported that experimental test results presented during the Alzheimer’s Association International Conference (AAIC) in July suggest the Holy Grail of dementia tests—one where the specimen can be collected in a doctor’s office during a routine screening exam—may be close at hand.

The AP story noted that “half a dozen research groups gave new results on various experimental tests, including one that seems 88% accurate at indicating Alzheimer’s risk.” And Richard Hodes, MD, Director of the National Institute on Aging, told AP, “In the past year, we’ve seen a dramatic acceleration in progress [on Alzheimer’s tests]. This has happened at a pace that is far faster than any of us would have expected.”

This could be a boon for medical laboratories seeking way to contribute more value to patient care. Especially among Alzheimer’s patients, who account for as many as 70% of all dementia cases.

Plasma Biomarker for Predicting Alzheimer’s

One of the experimental blood tests presented at the AAIC involved a 2018 study into “the potential clinical utility of plasma biomarkers in predicting brain amyloid-β burden at an individual level. These plasma biomarkers also have cost-benefit and scalability advantages over current techniques, potentially enabling broader clinical access and efficient population screening,” the researchers stated an article they published in Nature.

Dark Daily reported on this study in “Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear; Could Eventually Give Clinical Laboratories a Diagnostic Tool,” June 4, 2018. The test “measures abnormal versions of the protein [amyloid beta] that forms the plaques in the brain that are the hallmark of Alzheimer’s,” the AP story reported.

AP also reported that Japanese scientists at the AAIC presented results of a validation test conducted on 201 people who had either Alzheimer’s, other types of dementia, or little or no symptoms. They found that the test “correctly identified 92% of people who had Alzheimer’s and correctly ruled out 85% who did not have it, for an overall accuracy of 88%.”

Akinori Nakamura, MD, PhD, of the National Center for Geriatrics and Gerontology in Obu, Japan, was a member of the research team and first author of the research paper. He told the AP that the test results “closely matched those from the top tests used now—three types of brain scans and a mental assessment exam.”

Eric McDade, DO (above), Associate Professor of Neurology at Washington University in St. Louis, told Neurology Today, “The results reported here provide a relatively high level of confidence given that this is a relatively well characterized population with an amyloid PET scan to provide confirmation of a significant level of amyloid plaque burden in the brain.” Could this level of physician confidence lead to a clinical laboratory test based on the plasma biomarker? (Photo copyright: Washington University.)

Koichi Tanaka is a Japanese engineer who won the Nobel prize winner for chemistry. He heads the Koichi Tanaka Research Lab at Shimadzu Corp. (OTCMKTS:SHMZF) in Kyoto, Japan, and was on the team that developed the Amyloid beta biomarker test that was presented at AAIC. He told Bloomberg, “Our finding overturned the common belief that it wouldn’t be possible to estimate amyloid accumulation in the brain from blood. We’re now being chased by others, and the competition is intensifying.”

But Tanaka cautions that the test needs further study before it is ready for clinical use, and that for now “it belongs in the hands of drug developers and research laboratories,” Bloomberg reported.

Other Studies into Developing an Alzheimer’s Biomarker

Alzheimer’s is usually diagnosed after symptoms appear, such as memory loss. To arrive at their diagnoses, doctors often rely on medical history, brain imaging (MRI, CT), PET, and measurement of amyloid in spinal fluid.  

An article published on Alzforum, a website and news service dedicated to the research and treatment for Alzheimer’s and other related disorders, noted a study by King’s College London researchers who, using mass spectrometry, “found a panel of biomarkers that predicted with almost 90% accuracy whether cognitively normal people had a positive amyloid scan.”

Nicholas Ashton, PhD, neuroscientist and Wallenberg Postdoctoral Fellow at University of Gothenburg in Sweden, and first author of the King’s College study, explained that “Amyloid-burden and neurofilament light polypeptide (NFL) peptides were important in predicting Alzheimer’s, but alone they weren’t as predictable as when we combined them with novel proteins related to amyloid PET.”

The researchers published their study earlier this year in Science Advances. “Using an unbiased mass spectrometry approach, we have found and replicated with high accuracy, specificity, and sensitivity a plasma protein classifier reflecting amyloid-beta burden in a cognitively unimpaired cohort,” the researchers wrote.

Meanwhile, researchers at Washington University School of Medicine St. Louis, along with the German Center for Neurodegenerative Diseases, a member of the Helmholtz Association, stated in a news release that a blood test they developed works by detecting leaks of NFL before the onset of symptoms. When the protein is found in cerebrospinal fluid, it could be a sign that Alzheimer’s may develop, as well as point to other neurodegenerative conditions such as multiple sclerosis, brain injury, or stroke, the researchers stated.  

“This is something that would be easy to incorporate into a screening test in a neurology clinic,” Brian Gordon, PhD, Assistant Professor of Radiology at Washington University’s Mallinckrodt Institute of Radiology, and an author of the study, stated in the news release.

These parallel studies into screening for Alzheimer’s by researchers worldwide are intriguing. The favorable results suggest that someday there may be a screen for Alzheimer’s using a clinical laboratory blood test.

With Alzheimer’s affecting nearly six million Americans of all ages, such an assay would enable clinical laboratories to help many people.

—Donna Marie Pocius

Related Information:

Scientists Close in On Blood Test for Alzheimer’s

Advances in the Global Search for Blood Markers for Alzheimer’s Disease and Other Dementias

A Blood Test Can Predict Dementia. Trouble Is, There’s No Cure

Plasma Biomarker for Amyloid Correlates with Alzheimer’s Progression, Study Finds

High Performance Plasma Amyloid-β Biomarkers for Alzheimer’s Disease

Panel Blood Markers Signals Amyloid in Brain

A Plasma Protein Classifier for Predicting Amyloid Burden for Preclinical Alzheimer’s Disease

Blood Test Detects Alzheimer’s Damage Before Symptoms; Test Also May Identify Neurodegeneration in Other Brain Diseases

Blood-Brain Barrier Breakdown is an Early Biomarker of Human Cognitive Dysfunction

Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear Could Eventually Give Clinical Laboratories A Diagnostic Tool

UK Study Finds Late Diagnosis of Prostate Cancer a Worrisome Trend for UK’s National Health Service

Pathologists around the world will be interested to learn that, for the first time in the UK, prostate cancer has surpassed breast cancer in numbers of deaths annually and nearly 40% of prostate cancer diagnoses occur in stages three and four

Early detection of prostate cancer, and the ability to identify its more aggressive forms, are important goals for every nation’s health system. However, a new study in the United Kingdom (UK) will be of interest to all anatomic pathologists handling prostate biopsies. Researchers determined that late diagnosis of prostate cancer is an issue that should be addressed by healthcare policymakers in the UK.

In 2015, deaths due to prostate cancer surpassed those of breast cancer in the UK. According to data from Cancer Research UK, this trend continued into 2016 with 11,631 deaths from prostate cancer and 11,538 deaths from breast cancer. The trend continued even though breast cancer saw roughly 8,000 more new cases in 2015, according to the same data.

Now, a report from Orchid—a UK male cancer charity—highlights a trend that should interest medical laboratories and histopathology (anatomic pathology in the US) groups that analyze prostate cancer samples. They found that 37% of UK prostate cancer cases involved diagnoses in stages three or four.

Late-Stage Diagnosis of Prostate Cancer: The US and UK Compared

“With prostate cancer due to be the most prevalent cancer in the UK within the next 12 years, we are facing a potential crisis in terms of diagnostics, treatment, and patient care,” stated Rebecca Porta, Chief Executive of Orchid, in a press release. “Urgent action needs to be taken now if we are to be in a position to deliver world class outcomes for prostate cancer patients and their families in the future.”

Orchid Chief Executive Rebecca Porta (far right) and her team are shown above receiving a check from the Industrial Agents Society (AIS) to help fund the charity’s research into male specific cancers, such as prostate cancer. (Photo copyright: AIS.)

The latest data from the Centers for Disease Control and Prevention (CDC) on prostate cancer and mortality rates in the US shows an interesting picture. In 2014, 172,258 men received a prostate cancer diagnosis. However, deaths from prostate cancer were at 28,343.

According to Statista, an international statistics portal, the UK is home to more than 32.3-million males. And, Statista’s data shows the US is home to 159.1-million males. This implies that despite the US having nearly five times the number of males, the number of prostate cancer deaths/year in the UK is significantly higher in relation to population size.

Cancer Research UK notes that despite decreasing by 13% in the last decade, prostate cancer mortality rates are still 21% higher than in the 1970s.

Awareness and Early Detection Key Components in the Fight Against Cancer

A study published in BMC Public Health offers one possible explanation for this disparity.

“When compared to analogous countries in Europe, Canada, and Australia, older adults in the UK have markedly different survival outcomes,” noted lead author of the study Sara Macdonald, PhD, Lecturer in Primary Care at the Institute of Health and Wellbeing at the University of Glasgow, Scotland.

“Poorer outcomes in the UK are at least in part attributable to later stage diagnoses,” she explained. “Older adults should be vigilant about cancer. Yet, this is not reflected in the news media coverage of cancer risk. Taken together, invisibility, inaccuracy, and information overload build a skewed picture that cancer is a disease which affects younger people.”

While treatment options have improved in the past decade, early detection is a key part of successful treatment—especially as prostate cancer has both aggressive and slow variants. Effective timely health screening also is of critical concern.

In the US, however, prolific prostatic-specific antigen (PSA) testing and other screenings for chronic disease—particularly within the elderly population—is under increased scrutiny and criticism, which Dark Daily reported on in April. (See, “Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US,” April 11, 2018.)

New Tools to Detect Prostate Cancer

Faster diagnosis and the ability to detect whether a prostate cancer is slow or aggressive could help to shift these numbers around the world.

According to BBC News, the NHS hopes to reduce diagnosis times and make the screening process less invasive by using magnetic resonance imaging (MRI). Hashim Ahmed, PhD, Chairman of Urology, Imperial College London, told BBC News, “Fast access to high-quality prostate MRI allows many men to avoid invasive biopsies as well as allowing precision biopsy in those men requiring it to find high-risk tumors much earlier.”

A team from the University of Dundee is trialing a shear wave elastography imaging (SWEI) process to detect prostate tumors as well. Speaking with The Guardian, team leader and Chair of the School of Medicine at The University of Dundee, Dr. Ghulam Nabi, noted, “We have been able to show a stark difference in results between our technology and existing techniques such as MRI. The technique has picked up cancers which MRI did not reveal. We can now see with much greater accuracy what tissue is cancerous, where it is, and what level of treatment it needs. This is a significant step forward.”

Should these tools prove successful, they might help to reverse current trends in the UK and offer greater insight and options for the histopathology groups there, as well as the medical laboratories, oncologists, and other medical specialists helping to treat cancer.

Until then, raising awareness and streamlining both detection and treatment protocols will remain a critical concern, not just in the UK, but around the world as the human population continues to age.

—Jon Stone

Related Information:

Prostate Cancer: Four in 10 Cases Diagnosed Late, Charity Says

New Report Reveals 4 in 10 Prostate Cancer Cases Are Diagnosed Late and an Impending Crisis in Prostate Cancer Provision

Prostate Cancer Deaths Overtake Those from Breast Cancer

Cutting Prostate Cancer Diagnosis Times

Prostate Cancer on the Rise; Time to Revisit Guidelines?

More High-Risk Prostate Cancer Now in the US than Before

Prostate Cancer Breakthrough as UK Team Develops More Accurate Test

Mass Media and Risk Factors for Cancer: The Under-Representation of Age

Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US

Genetic Fingerprint Helps Researchers Identify Aggressive Prostate Cancer from Non-aggressive Types and Determine If Treatment Will Be Effective

Health Systems Putting Imaging Services, Such As MRIs, In Strip Malls and Shopping Centers To Help Patients with Cost and Convenience

Recognizing the need to serve patients with high-deductible health plans, hospital systems are opening healthcare centers in outpatient settings where patients can receive care and undergo procedures—including clinical laboratory tests—more conveniently and for less cost

Health systems are putting medical imaging services, such as MRIs, in strip malls and shopping centers as a way to make it easier for patients. Such locations can also offer lower-cost procedures because of lower overhead compared to imaging centers located in hospitals. This trend to offer patients more convenient service at a lower cost is something that clinical laboratory managers and pathologists should watch and understand.

One driver behind this trend is the growing number of Americans enrolled in High Deductible Health Plans (HDHPs), where deductibles can exceed $6,000 for individuals and $12,000 for families. With such high deductibles, patients are now keenly focused on the cost of their healthcare. Medical laboratories and anatomic pathology groups have been impacted by this trend, as more patients shell out cash to pay for walk-in procedures and providers must collect full payments for services rendered.

Hospitals and health systems recognize the increased demand for outpatient, lower-priced medical services, along with price transparency. Patients with HDHPs are one reason why hospital bad debt is growing.

Healthcare Shopping Drives Lower Costs and Convenience

Price shopping on the Internet for medical services also is becoming more popular due to the availability of online doctor and facility ratings and easily-accessible price comparisons.

There are more than 7,000 stand-alone imaging centers in the US that operate independently of hospitals. About 70% of diagnostic imaging services occur in hospital settings with the other 30% performed in outpatient facilities.

According to Amino, a healthcare transparency company based in San Francisco, the cost for an MRI can vary significantly depending on where a patient lives and what type of facility is utilized for the test. Their research found that the cost of a limb MRI can range from hundreds of dollars at a freestanding facility to as much as $4,000 at a hospital. In some states, the price difference between getting an MRI at a hospital versus a stand-alone facility was almost $2,000. The average cost of having an MRI performed in a hospital setting is $2600.

Based on data from Amino, the graphic above illustrates the wide range of prices for MRIs throughout the country, and the cost disparity between hospital and free-standing medical imaging centers. In the future, pathologists and clinical laboratory managers can expect to see the publication of similar graphs that show the variation in the cost of clinical laboratory tests and anatomic pathology procedures, not just by state, but by individual laboratories. (Graphic copyright: MBO.)

Smart Choice MRI, based in Mequon, Wis., charges a maximum price of $600 for an MRI. The company now has 17 locations in Illinois, Minnesota, and Wisconsin, but plans to have 90 facilities within the next three years.

“The rise of high deductible health plans has fueled consumers who understand their options and demand a higher level of service from their providers,” Rick Anderson, Chief Executive Officer of Smart Choice MRI told the StarTribune. “Quality, service-focused care at a fair, transparent price has never been more important.”

Anderson added that his company can handle 94% of MRI procedures in their convenient, freestanding imaging facilities.

“I think the quality is very good, but we’ve combined the cost and quality, and most importantly the convenience of being in the neighborhood where people are shopping,” Anderson said. “If you look at our Richfield (Minnesota) location, we’re literally next to SuperTarget, Caribou Coffee, Noodles and Company, and Qdoba.”

Public and Private Health Insurers Shift Payments to Free-standing Facilities

Anthem recently announced they will no longer pay for outpatient MRIs and CT scans performed at hospitals in almost all of the states where the health insurer does business. They are requiring patients to have the tests performed in free-standing imaging facilities in an effort to cut costs and lower premiums. This change could affect 4.5 million people in 13 of the 14 states Anthem serves, with New Hampshire being the exception.

Diagnostic imaging is not the only medical service transitioning to outpatient facilities.

In July, the Centers for Medicare and Medicaid Services (CMS) announced that it is considering payment approval for total hip and knee replacements performed in outpatient settings. This change could go into effect as early as next year.

According to Steve Miller, Chief Operating Officer at Ambulatory Surgery Center Association, an estimated 25-50% of joint replacements could be performed on an outpatient basis.

“There’s more and more comfort among surgeons who are coming out of residencies where they trained to do surgeries on an outpatient basis,” Miller told Modern Healthcare. “The volumes are doubling year over year.”

Surgeons Approve of Free-standing Surgery Centers

There are currently more than 5,500 ambulatory surgery centers in the country and upwards of 200 of those facilities are performing outpatient joint replacement procedures. Three years ago, there were only around 25 facilities providing these services.

In 2015, there were more than 658,000 total hip and knee replacements performed on Medicare beneficiaries, according to CMS data. In 2014, the government paid more than $7 billion for the hospitalization costs of these two procedures. The CMS estimates that the cost for uncomplicated knee replacement surgeries in 2018 will be $12,381 for an inpatient procedure and $9,913 for the outpatient rate.

Physicians feel that performing joint replacements in outpatient facilities could reduce costs by up to 50%.

“I could do maybe 20% of my Medicare patients on an outpatient basis, as long as they have the support and structure at home to help them recover,” said Matthew Weresh, MD, a physician at Des Moines Orthopedic Surgeons (DMOS) in the Modern Healthcare article. “It’s a great move by Medicare.” DMOS plans to begin performing joint replacements at an ambulatory surgery center later this year.

Pathologists would be wise to monitor this trend and anticipate how anatomic pathology services might shift towards lower-cost settings. For clinical laboratories, this trend further illustrates the need to prepare for more consumers paying cash for their medical services and seeking cost-effective, high-quality options.

—JP Schlingman

Related Information:

Coming Soon to a Strip Mall Near You: An MRI Provider

MRI Competition Heats up in Twin Cities

Anthem’s New Outpatient Imaging Policy Likely to Hit Hospitals’ Bottom Line

Free Standing Imaging Center and Hospitals

Need an MRI? It Pays to Shop Around. Big Time.

Hospitals Leery of CMS Proposal to Pay for Joint Replacements in ASCs

Decline in Imaging Utilization Could Be Linked to Changes in Policies and Funding for Diagnostics; Could Something Similar Happen with Anatomic Pathology?

New study analyzes the dramatic decline in the utilization of imaging diagnostics between 2008 and 2014 and suggests that reductions in imaging use could be the result of changes in federal policy, increased deductibles, and cost-cutting focuses

Anatomic pathologists have experienced sustained cuts to reimbursements for both technical component and professional component services during the past eight to 10 years. But what has not happened to pathology is a 33% decline in the volume of biopsies referred to diagnosis. Yet that is what some studies say has happened to imaging reimbursement since 2006.

Using Medicare data for Part B imaging procedures covering the years 2001 to 2014, researchers at a major university identified that, beginning in 2006, the total reimbursement for imaging procedures declined at a steady rate throughout the following eight years covered by the study. It is unclear what implications the finding of this study of imaging utilization might predict for the utilization of advance anatomic pathology services.

Routine Use of Imaging in Diagnostics is Slowing Down

The research into imaging utilization was conducted at Thomas Jefferson University and published in the journal Health Affairs. Led by David C. Levin, MD, Emeritus Professor and former Chair of the Department of Radiology at Thomas Jefferson University Hospital, the researchers examined imaging data from Medicare Part B (2001-2014) to determine the reason and rate of “slowdown” in routine use of imaging in diagnostics.

The researchers calculated utilization rates for “advanced” imaging modalities and component relative value unit (RVU) rates for all imaging modalities. They determined that trends in imaging rates and RVU rates rose between 2000 and 2008, but then sharply declined from 2008 to 2014. The researchers theorized that the reduction might have been due to changes in federal policy, increasing deductibles, and focus on cost-cutting by hospitals and healthcare providers.

Levin, along with Thomas Jefferson University associates Vijay M. Rao, MD, FACR, current Chair of Radiology, and Laurence Parker, PhD, Associate Professor of Radiology; and University of Wisconsin-Madison statistics Professor Charles D. Palit, PhD, argue that the decrease in imaging orders might reduce diagnostic costs, but also could negatively impact surgical pathologists, radiologists, medical researchers, and patients themselves.

In a Modern Healthcare article, Levin states that the reduction in utilization of imaging and radiology could be a slippery slope leading to decreased access to life-saving diagnostic tools that could leave patients “not getting the scans they probably need.”

What’s Fueling the Multi-Year Decline in Utilization of Imaging and Radiology?

In the Journal of American College Radiology, Levin, Rao, and Parker, attempt to “assess the recent trends in Medicare reimbursements to radiologists, cardiologists, and other physicians for non-invasive diagnostic imaging (NDI).”

Using data acquired from Medicare part B databases, the authors reported that total reimbursements for NDI peaked at $11.9 billion in 2006, but saw a steep decline of 33% to just over $8 billion in 2015. They attribute some of this decline as a result of the Deficit Reduction Act of 2005, which went into effect in 2007, as well as other cuts to NDI reimbursement funding. Reimbursement to radiologists, according to Levin et al, dropped by more than 19.5%, and reimbursement to cardiologists dropped nearly 45% between 2006 and 2015.

Surgical pathologists may see parallels in the total reimbursement for imaging during the years 2002-2015 compared to pathology technical component and professional component reimbursement during those same years. Taken from the Thomas Jefferson University study, the graphic above shows “total Part B payments for non-invasive diagnostic imaging to all physicians under the Medicare Physician Fee Schedule, 2002 to 2015. Vertical axis shows billions of dollars. The abrupt decline in 2007 was due to the Deficit Reduction Act. The declines in 2009, 2010, and 2011 were due largely to code bundling in, respectively, transthoracic echocardiography, radionuclide myocardial perfusion imaging, and CT of the abdomen and pelvis.” (Caption and image copyright: Thomas Jefferson University.)

In different Journal of American College Radiology article, Levin and Rao outline their concerns over another suspected cause for the decline in imaging utilization—the American Board of Internal Medicine Foundation (ABIMF) Choosing Wisely initiative.

According to Levin and Rao, the Choosing Wisely initiative was intended “to reduce the use of tests and treatments that were felt to be overused or often unnecessary.” Imaging examinations were included in the list of tests that were deemed to be “of limited value” in many situations. Levin and Rao suggested that there might have been a need to curtail testing pushed by payers, policymakers, and physicians at the time, but that the Choosing Wisely initiative could have added to a decline in imaging testing spurred on by the confusion physicians felt when attempting to access unclear scenarios and recommendations for the 124 imaging tests listed.

Imaging Decline Could Have Unintended Consequences for Providers and Patients 

In a Radiology Business article, Levin outlined some of the unintended consequences facing healthcare due to the reduction in imaging utilization. He states that “private imaging facilities are starting to close down” and “MRI and other advanced imaging exams are beginning to shift into hospital outpatient facilities.” He predicts that the shift from private facilities to hospital facilities could cause imaging costs to increase for customers and healthcare providers.

Levin suggests that Medicare could “raise the fees a little and make the private offices a little more viable.” The profit margins, Levin argues, “are so low right now that you basically can’t run a business.” Medicare as a program might be seeing huge savings, Levin notes in several articles, but physicians, laboratories, and patients are feeling the pinch as a result.

In an interview with Physicians Practice, Rao echoed Levin’s concerns. “Policy makers lack understanding of the value of imaging and spectrum of the services provided by radiologists,” he declared. “On an institutional level, under the new payment models, radiology is transitioning to a cost center and radiologists often don’t have a seat at the table.”

Rao points out that this devaluing of radiologists’ work affects not only healthcare facilities, but patients themselves. Radiologists provide “major contributions to patient care by making accurate diagnoses, and doing minimally invasive treatments given many technological advances leading to appropriate management and improved outcomes,” he argues. How long before Pathology follows a similar track?

Balancing Cost and Quality in Testing Without Sacrificing Patient Needs

The fear seems to be that the push to lower costs by eliminating unnecessary imaging is inhibiting radiologists and diagnosticians from providing necessary imaging for patients. And that delaying diagnoses affects the ability of healthcare providers to provide adequate and timely patient care. Rao suggests, however, that physicians’ use of medical imaging could simply be evolving.

“There were other factors that also helped limit the rapid growth, such as greater attention by physicians to practice guidelines, concerns about radiation exposure to patients, and the Great Recession of 2007 to 2009,” Rao noted in a Thomas Jefferson University news release. “However, we expect that additional changes, such as the advent of lung cancer and other screening programs, and the use of computerized clinical decision support, will continue to promote and support appropriate use of imaging technology.”

The drive to reduce healthcare expenditures should not be dismissed. We may soon see parallels in the rise and fall of imaging utilization for genetic testing, surgical pathology, and other new and expensive clinical laboratory technologies as policymakers attempt to balance increased spending against the clinical value of these diagnostic tools.

Amanda Warren

Related Information:

The Overuse of Imaging Procedures on the Decline Since 2008

After Nearly a Decade of Rapid Growth, Use and Complexity of Imaging Declined, 2008–2014

Reducing Inappropriate Use of Diagnostic Imaging Through the Choosing Wisely Initiative

The Recent Losses in Medicare Imaging Revenues Experienced by Radiologists, Cardiologists, and Other Physicians

Five Minutes with David C. Levin, MD: Outpatient Imaging Cuts and Unintended Consequences

Ten Questions with Vijay M. Rao, MD, FACR

Diagnostic Imaging Transitions from Volume to Value

Imaging Use Plunges as Coding, Reimbursement Tightens Up

Has the Time Come for Integration of Radiology and Pathology?

Reference Pricing and Price Shopping Hold Potential Peril for Both Clinical Laboratories and Consumers

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