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American Heart Association Announces CKM Syndrome to Describe ‘Strong Connection’ between Multiple Diseases

Newly-defined Cardiovascular-Kidney-Metabolic Syndrome (CKM) means physicians will be in close collaboration with clinical laboratories to make accurate diagnoses

Based on newly-identified “strong connections” between cardiovascular disease (CVD, or heart disease), kidney disease, Type 2 diabetes, and obesity, the American Heart Association (AHA) is calling for a “redefining” of the risk, prevention, and management of CVD, according to an AHA news release.

In a presidential advisory, the AHA defines a newly described systemic health disorder called Cardiovascular-Kidney-Metabolic Syndrome (CKM). The syndrome “is a systemic disorder characterized by pathophysiological interactions among metabolic risk factors, CKD (chronic kidney disease), and the cardiovascular system leading to multi-organ failure and a high rate of adverse cardiovascular outcomes.”

A CKM diagnosis, which is meant to identify patients who are at high risk of dying from heart disease, is based on a combination of risk factors, including:

  • weight problems,
  • issues with blood pressure, cholesterol, and/or blood sugar,
  • reduced kidney function. 

CKM is a new term and doctors will be ordering medical laboratory tests associated with diagnosing patients with multiple symptoms to see if they match this diagnosis. Thus, clinical laboratory managers and pathologists will want to follow the adoption/implementation of this new recommendation.

The AHA published its findings in its journal Circulation titled, “Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory from the American Heart Association.”

“The advisory addresses the connections among these conditions with a particular focus on identifying people at early stages of CKM syndrome,” said Chiadi Ndumele, MD, PhD (above), Associate Professor of Medicine at Johns Hopkins University and one of the authors of the AHA paper, in a news release. “Screening for kidney and metabolic disease will help us start protective therapies earlier to most effectively prevent heart disease and best manage existing heart disease.” Clinical laboratories will play a key role in those screenings and in diagnosis of the new syndrome. (Photo copyright: Johns Hopkins University.)

Stages of CKM Syndrome

In its presidential advisory, the AHA wrote, “Cardiovascular-Kidney-Metabolic (CKM) syndrome is defined as a health disorder attributable to connections among obesity, diabetes, chronic kidney disease (CKD), and cardiovascular disease (CVD), including heart failure, atrial fibrillation, coronary heart disease, stroke, and peripheral artery disease. CKM syndrome includes those at risk for CVD and those with existing CVD.”

The five stages of CKM syndrome, which the AHA provided to give a framework for patients to work towards regression of the syndrome, are:

  • Stage 0: No CKM risk factors. Individuals should be screened every three to five years for blood pressure, cholesterol, and blood sugar levels, and for maintaining a healthy body weight.
  • Stage 1: Excess body fat and/or an unhealthy distribution of body fat, such as abdominal obesity, and/or impaired glucose tolerance or prediabetes. Patients have risk factors such as weight problems or prediabetes and are encouraged to make healthy lifestyle changes and try to lose at least 5% of their body weight.
  • Stage 2: Metabolic risk factors and kidney disease. Includes people who already have Type 2 diabetes, high blood pressure, high triglyceride levels, and/or kidney disease. Medications that target kidney function, lower blood sugar, and which help with weight loss should be considered at this stage to prevent diseases of the heart and blood vessels or kidney failure.
  • Stage 3: Early cardiovascular disease without symptoms in people with metabolic risk factors or kidney disease or those at high predicted risk for cardiovascular disease. People show signs of disease in their arteries, or have heart function issues, or may have already had a stroke or heart attack or have kidney or heart failure. Medication may also be needed at this stage.
  • Stage 4: Symptomatic cardiovascular disease in people with excess body fat, metabolic risk factors or kidney disease. In this stage, people are categorized as with or without having kidney failure. May also have already had a heart attack, stroke or heart failure, or cardiovascular conditions such as peripheral artery disease or atrial fibrillation.  

“We now have several therapies that prevent both worsening kidney disease and heart disease,” said Chiadi Ndumele, MD, PhD, Associate Professor of Medicine at Johns Hopkins University and one of the authors of the Circulation paper, in a news release. “The advisory provides guidance for healthcare professionals about how and when to use those therapies, and for the medical community and general public about the best ways to prevent and manage CKM syndrome.”

According to an AHA 2023 Statistical Update, one in three adults in the US have three or more risk factors that contribute to cardiovascular disease, metabolic disorders, or kidney disease. While CKM affects nearly every major organ in the body, it has the biggest impact on the cardiovascular system where it can affect the blood vessels, heart muscle function, the rate of fatty buildup in the arteries, electrical impulses in the heart and more. 

“There is a need for fundamental changes in how we educate healthcare professionals and the public, how we organize care and how we reimburse care related to CKM syndrome,” Ndumele noted. “Key partnerships among stakeholders are needed to improve access to therapies, to support new care models, and to make it easier for people from diverse communities and circumstances to live healthier lifestyles and to achieve ideal cardiovascular health.”

New AHA Risk Calculator

In November, the AHA announced PREVENT (Predicting risk of cardiovascular disease EVENTs), a tool that doctors can use to assess a person’s risk for heart attack, stroke, and heart failure. The new risk calculator, which incorporates CKM, allows physicians to evaluate younger people as well, and examine their long-term risks for cardiovascular issues.

“A new cardiovascular disease risk calculator was needed, particularly one that includes measures of CKM syndrome,” said Sadiya Khan, MD, Professor of Cardiovascular Epidemiology at Northwestern University’s Feinberg School of Medicine, in an AHA news story.

Doctors can use PREVENT to assess people ages 30 to 79 and predict risk for heart attack, stroke, or heart failure over 10 to 30 years.

“Longer-term estimates are important because short-term or 10-year risk in most young adults is still going to be low. We wanted to think more broadly and apply a life-course perspective,” Khan said. “Providing information on 30-year risk may reveal earlier opportunities for intervention and prevention efforts in younger people.”

According to CDC data, about 695,000 people died of heart disease in the US in 2021. That equates to one in every five deaths. Clinical pathologists will need to understand the AHA recommendations and how doctors will be ordering clinical laboratory tests to determine if a patient has CKM. Then, labs will play a role in helping doctors monitor patients to optimize health and prevent acute episodes that put patients in the hospital.

—JP Schlingman

Related Information:

‘CKM Syndrome’ Gives New Name to Multi-system Heart Disease Risk

Cardiovascular-Kidney-Metabolic Health: A Presidential Advisory from the American Heart Association

New Tool Brings Big Changes to Cardiovascular Disease Predictions

AHA Advisory Focuses on Cardiovascular-Kidney-Metabolic Syndrome

What You Need to Know about CKM Syndrome

Heart Disease Risk, Prevention and Management Redefined

AHA: Heart and Stroke Statistics

CDC: Heart Disease Facts

Cancer Researchers Use Astronomy Analysis Algorithms to Develop Platform for Locating and Examining Predictive Biomarkers in Tumors

Yet another example that technologies from non-medical fields continue to find their way into anatomic pathology and clinical laboratory medicine

Anatomic pathologists and medical laboratory scientists may soon have new tools in the fight against cancer, thanks to researchers at the Mark Foundation Center for Advanced Genomics and Imaging at Johns Hopkins University and Bloomberg-Kimmel Institute for Cancer Immunotherapy.

Using algorithmic technology designed for mapping the stars, the scientists have created an imaging/spatial location platform called AstroPath which may help oncologists develop immunotherapies that work best on specific cancers. Such a capability is key to effective precision medicine techniques.

Dark Daily has regularly pointed out that technologies developed in other fields of science will eventually be brought into anatomic pathology and clinical laboratory medicine. Use of the star-mapping technology in oncology and the diagnosis of cancer is one such example.

In “Analysis of Multispectral Imaging with the AstroPath Platform Informs Efficacy of PD-1 Blockade,” published in the journal Science, the multi-institution research team wrote, “Here, we present the AstroPath platform, an end-to-end pathology workflow with rigorous quality control for creating quantitative, spatially resolved mIF [multiplex immunofluorescence] datasets. Although the current effort focused on a six-plex mIF assay, the principles described here provide a general framework for the development of any multiplex assay with single-cell image resolution. Such approaches will vastly improve the standardization and scalability of these technologies, enabling cross-site and cross-study comparisons. This will be essential for multiplex imaging technologies to realize their potential as biomarker discovery platforms and ultimately as standard diagnostic tests for clinical therapeutic decision-making.

“Drawing from the field of astronomy, in which petabytes of imaging data are routinely analyzed across a wide spectral range, [the researchers] developed a platform for multispectral imaging of whole-tumor sections with high-fidelity single-cell resolution. The resultant AstroPath platform was used to develop a multiplex immunofluorescent assay highly predictive of responses and outcomes for melanoma patients receiving immunotherapy,” the researchers added.

Using Star Mapping Software to Fight Cancer

“The application of advanced mapping techniques from astronomy has the potential to identify predictive biomarkers that will help physicians design precise immunotherapy treatments for individual cancer patients,” said Michele Cleary, PhD, CEO of the Mark Foundation for Cancer Research, in a Johns Hopkins news release.

Although the universe we live in and the universe of a cancerous tumor may not seem related, the fact is the same visualization technology can be used to map them both.

“What should be pointed out is that astronomy is mapping the sky in three dimensions, so keeping the spatial relationships while also identify each heavenly body is the goal of these algorithms,” said Robert Michel, Publisher and Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

“Both aspects of that information technology have value in surgical pathology, where the spatial relationship of different cells and cell structures is relevant and important while also having the ability to identify and characterize different types of cells and cell structures. This technology appears to also be capable of identifying multiple biomarkers,” he added.

AstroPath graphic

The image above, taken from the researchers’ Science paper, illustrates the “strong parallels between multispectral analyses in astronomy and emerging multiplexing platforms for pathology.” The researchers wrote, “the next generation of tissue-based biomarkers are likely to be identified by use of large, well-curated datasets. To that end, image analysis approaches originally developed for astronomy were applied to pathology specimens to produce trillions of pixels of robust tissue imaging data and facilitate assay and atlas development.” Anatomic pathologists may be direct recipients of new cancer diagnostic tools based on the AstroPath platform. (Photo copyrights: Johns Hopkins University/Mark Foundation Center for Advanced Genomics/Bloomberg-Kimmel Institute.)

AstroPath Provides 1,000 Times the Information Content from A Single Biopsy

According to the news release, “[The researchers] characterized the immune microenvironment in melanoma biopsies by examining the immune cells in and around the cancer cells within the tumor mass and then identified a composite biomarker that includes six markers and is highly predictive of response to a specific type of an immunotherapy called Anti-PD-1 therapy.”

This is where the use of AstroPath is truly innovative. Previously, researchers could only identify those biomarkers one at a time, through a painstaking process.

“For the last 40 years, pathology analysis of cancer has examined one marker at a time, which provides limited information,” said Drew Pardoll, MD, PhD, Director of the Bloomberg-Kimmel Institute for Cancer Immunotherapy and a Johns Hopkins professor of oncology, in the news release. “Leveraging new technology, including instrumentation to image up to 12 markers simultaneously, the AstroPath imaging algorithms provide 1,000 times the information content from a single biopsy than is currently available through routine pathology,” he added.

More information about a cancerous tumor means clinicians have more tools to combat it. Treatment becomes less about finding the right immunotherapy and more about treating it immediately.

“This facilitates precision cancer immunotherapy—identifying the unique features of each patient’s cancer to predict who will respond to a given immunotherapy, such as anti-PD-1, and who will not. In doing so, it also advances diagnostic pathology from uniparameter to multiparameter assays,” Pardoll said.

Big Data and Data Analysis Is the Future of Precision Medicine

The use of data in science is changing how researchers, clinicians, pathologists, and others provide healthcare in the modern world. When it is properly collected and analyzed, data holds the key to precision medicine’s personalized and targeted patient care.

“Big data is changing science. There are applications everywhere, from astronomy to genomics to oceanography,” said Alexander S. Szalay, PhD, Bloomberg Distinguished Professor and Professor in the Department of Computer Science at Johns Hopkins University, and Director of the Institute for Data Intensive Engineering and Science (IDIES), in the news release.

“Data-intensive scientific discovery is a new paradigm. The technical challenge we face is how to get consistent, reproducible results when you collect data at scale. AstroPath is a step towards establishing a universal standard,” he added.

Should AstroPath prove to be a clinically safe and accurate method for developing precision medicine cancer therapies, anatomic pathologists can look forward to exciting new ways to diagnose cancer and determine the best courses of treatment based on each patient’s unique medical needs.

—Dava Stewart

Related Information

Astronomy Meets Pathology to Identify Predictive Biomarkers for Cancer Immunotherapy

Analysis of Multispectral Imaging with the AstroPath Platform Informs Efficacy of PD-1 Blockade

Astronomy Meets Pathology: An Interdisciplinary Effort to Discover Predictive Biomarker Signatures for Immuno-Oncology

From Stars to Cells: Johns Hopkins Researchers Discover Predictive Spatial Phenotypic Signatures with AstroPath

Astronomy and Pathology Join Forces to Predict Immunotherapy Response: Q/A with Spatial Biology Experts

Amazon’s Prime Air Drone Fleet Receives FAA Approval to Make Deliveries to Customers, Could Clinical Laboratory Specimens and Supplies be Next?

Delivery of clinical laboratory specimens and medical supplies by drone is beginning to happen in different parts of the world

The idea that fleets of flying drones may someday legally transport clinical laboratory specimens may sound good—it may even be beneficial from a healthcare perspective—but it also could be hugely disruptive to medical labs that maintain large and expensive courier/logistics capabilities. 

So, the announcement that the FAA had granted approval to Amazon’s new drone delivery fleet—Amazon Prime Air—may come as something of a mixed blessing to clinical laboratory managers and large healthcare networks.

Nevertheless, it’s done. Amazon Prime Air has joined Alphabet Inc’s Wing and the United Parcel Services’ Flight Forward as “the only companies that have gotten FAA approval to operate under the federal regulations governing charter operators and small airlines,” Bloomberg reported.

But will this trend bode well for clinical laboratories?

Does Amazon Plan to Deliver Clinical Laboratory Specimens?

As yet, Amazon has not announced its intention to deliver clinical laboratory specimens. But given the company’s trajectory as a disrupter of traditional retail and shipping industries, it seems reasonable that competing with Wing and Flight Forward might be part of Amazon’s plan.

Wing and UPS are already operating fledgling clinical laboratory delivery networks in the US and other nations, such as Australia and Switzerland. Wing has been testing limited drone deliveries in Christiansburg, VA, since it received FAA approval to operate drone deliveries last year. UPS received similar approval last year to operate drones to deliver biological specimens and clinical laboratory supplies between physicians’ offices and the central clinical laboratory on WakeMed’s medical campus in Raleigh, NC.

Dark Daily covered both of these events in “UPS and WakeMed Now Use Aerial Drone for Daily Transport of Clinical Laboratory Specimens; In Australia, Google Wing Initiates Drone Delivery Service.”

Amazon’s MK27 drone
Amazon’s MK27 drone (above) is a hybrid aircraft that can take off and land vertically like a helicopter and sustain forward flight. The drone has several built-in safety features, including thermal cameras, depth cameras, onboard computers and sonar to detect hazards in its path and navigate around them. Click here to watch a video of the drone in flight. (Video copyright: Amazon.)

Amazon’s drones can fly up to 7.5 miles from a distribution site (a 15-mile round trip) and can deliver packages that weigh less than five pounds to customers. The goal is to deliver small items that can fit in the drone’s cargo box to consumers in under 30 minutes. 

Are Drones the Future of Medical Laboratory Specimen Delivery?

Routine deliveries via drones are still a long way off as more trial runs are needed and the FAA has to develop standards and regulations for drone delivery operations to maintain order in the skies. However, in a statement, the FAA said it is trying to support innovation in the expanding drone arena while ensuring that the devices operate safely. The FAA plans to finalize a set of regulations for drones by the end of this year, Bloomberg reported.

“This certification is an important step forward for Prime Air and indicates the FAA’s confidence in Amazon’s operating and safety procedures for an autonomous drone delivery service that will one day deliver packages to our customers around the world,” David Carbon, Vice President Prime Air at Amazon, said in a statement to Business Insider. “We will continue to develop and refine our technology to fully integrate delivery drones into the airspace and work closely with the FAA and other regulators around the world to realize our vision of 30-minute delivery.”

So, will Amazon one day announce plans to deliver medical supplies and clinical laboratory specimens in under 30 minutes too? It wouldn’t be unreasonable to believe in the possibility.

Dark Daily previously covered similar drone delivery services under development for healthcare situations around the world. In “Drones Used to Deliver Clinical Laboratory Specimens in Switzerland,” we reported how a multiple-facility hospital group in Switzerland was using drones to deliver lab samples between two of their locations.

In “WakeMed Uses Drone to Deliver Patient Specimens,” our sister publication, The Dark Report, covered how in April, 2019, clinical lab professionals at WakeMed Health and Hospitals completed the first successful revenue-generating commercial transport of lab supplies by drone in the United States. The satellite lab now sends urine, blood, and other patient specimens for routine testing to the main lab.

And in “California Company Creates ‘Uber for Blood’ to Speed the Transport of Life-Saving Medical Laboratory Supplies and Blood Products in Rwanda,” we reported how drones are being utilized to transport vital blood supplies to remote areas of Rwanda and Tanzania.

Dark Daily also reported in 2017 that researchers from Johns Hopkins University had successfully flown a drone carrying lab specimens more than 161 miles across the Arizona desert, setting a US record for the longest distance drone delivery of viable medical specimens.

Amazon would fit right in.

Though regular drone delivery of medical supplies and clinical laboratory specimens may take some time to develop, it is a trend that laboratory managers should watch closely. The potential for drones to safely and inexpensively transport clinical laboratory specimens could become a reality sooner than expected.

—JP Schlingman

Related Information:

Amazon’s Drone Delivery Fleet Hits Milestone with FAA Clearance

FAA Approves Amazon’s Drone Delivery Fleet

FAA Clears Amazon’s Fleet of Prime Air Drones for Liftoff

Here’s Amazon’s New Transforming Prime Air Delivery Drone

UPS and WakeMed Now Use Aerial Drone for Daily Transport of Clinical Laboratory Specimens; In Australia, Google Wing Initiates Drone Delivery Service

Drones Used to Deliver Clinical Laboratory Specimens in Switzerland

California Company Creates ‘Uber for Blood’ to Speed the Transport of Life-Saving Medical Laboratory Supplies and Blood Products in Rwanda

Johns Hopkins’ Test Drone Travels 161 Miles to Set Record for Delivery Distance of Clinical Laboratory Specimens

Chairman and CEO David Abney Explains UPS’ Drive Toward Drone Technology

Taiwan’s Containment of COVID-19 Outbreak Demonstrates Importance of Rapid Response, Including Fast Access to Clinical Laboratory Tests

By taking early measures to combat the spread, the country had a medical laboratory test for COVID-19 available as early as Jan. 24, and was able to focus medical laboratory testing on the most at-risk individuals

With the Coronavirus disease 2019 (COVID-19) outbreak dominating headlines and medical laboratories under growing pressure to increase testing capacity, Taiwan’s rapid response to the pandemic could provide a critical model for other countries to follow.

Given its proximity to mainland China—just 81 miles—and the large number of individuals who frequently travel back and forth between the countries, Taiwan was at risk of having the second-highest number of imported COVID-19 cases, according to a model developed by researchers at Johns Hopkins University and the University of New South Wales Sydney. News reports indicate that, each year, about 60,000 flights carry 10 million passengers between Taiwan and China.

But after the first reports emerged of the infection in Wuhan, China, “Taiwan quickly mobilized and instituted specific approaches for case identification, containment, and resource allocation to protect the public health,” wrote C. Jason Wang, MD, PhD; Chun Y. Ng, MBA, MPH; and Robert H. Brook, MD, ScD, in an article for the Journal of the American Medical Association (JAMA), titled, “Response to COVID-19 in Taiwan Big Data Analytics, New Technology, and Proactive Testing.”

Data from Taiwan’s Centers for Disease Control (CDC) and Central Epidemic Command Center (CECC) indicate that the country has managed to contain the outbreak thanks to these aggressive actions.

As of March 19, Taiwan’s CECC reported a total of 108 laboratory-confirmed COVID-19 infections. That compares with 81,155 in China, 41,035 in Italy, and 10,755 in the US, according to data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. When the World Health Organization (WHO) reports on the number of COVID-19 cases by country, it includes the number of COVID-19 cases from Taiwan under the totals for the People’s Republic of China. WHO made this decision several years ago, under pressure by China to not recognize Taiwan as an independent nation.

The World Population Review website says Taiwan’s population is about 23.8 million. But its infection rate is low even on a per capita basis: Approximately 45 infections per million population, compared with 6,784 in Italy, 564 in China, and 326 per million in the US.

The JAMA authors noted that Taiwan was prepared for an outbreak after its experience with the severe acute respiratory syndrome (SARS) pandemic in 2003, which also originated in China.

Timeline of COVID-19 Outbreak at the Earliest Stages

Taiwan apparently learned a lesson about preparedness from the SARS outbreak the rest of the world did not and that enabled the tiny nation to respond immediately to the novel Coronavirus threat.

The country’s efforts began on Dec. 31 with inspections of flight arrivals from Wuhan. “When there were only a very few cases [of COVID-19] reported in China, [Taiwanese health authorities] already went onto every airplane that came from Wuhan,” C. Jason Wang, MD, PhD, an Associate Professor of Pediatrics and Director of the Center for Policy, Outcomes, and Prevention at Stanford University and lead author of the JAMA report, told Vox. “Health officials came on the airplane and checked people for symptoms,” he added.

Travelers who had recently visited Wuhan and displayed symptoms of pneumonia were quarantined at home for 14 days. Taiwan’s CDC reported that quarantined individuals were being tested for the 2019-nCoV coronavirus (later renamed to SARS-CoV-2) soon after it was identified. The CECC, activated in January to coordinate the government’s response, reported the first confirmed imported case on Jan. 21.

On Jan. 24, their CDC announced that testing for the virus was being performed at the CDC and eight designated hospitals. Testing included samples from physicians around the country. As of Feb. 17, daily testing capacity was about 1,300 samples, the JAMA authors reported.

Wang told Vox that aggressive measures to identify and isolate at-risk individuals at the earliest stages reduced the volume of clinical laboratory tests that had to be performed. “Here in the US and elsewhere, we’re now seeing community spread,” he said. “It’s probably been here for a while. And so now we’re trying to see, ‘Oh, how many people should we test?’ Then, you really need to have a very large capacity in the beginning.”

“I think the US has enormous capacity that’s currently not being used,” C. Jason Wang, MD, PhD (above), Associate Professor of Pediatrics and Director of the Center for Policy, Outcomes, and Prevention at Stanford University and lead author of the JAMA report, told Vox. “We have big tech companies that really could do a lot, right? We ought to get the big companies together. Get the governors together, get the federal government agencies to work with each other, and try to find innovative ways to think about how to best do this. We’ve got the smartest people here in the US because they come from everywhere. But right now, those are untapped resources. They’re not working together. And the federal government, the agencies, they need to collaborate a little more closely.” (Photo copyright: Stanford University.)

More Actions by Authorities

The JAMA report supplementary materials notes a total of 124 actions taken by Taiwanese authorities between Jan. 20 and Feb. 24 to contain the outbreak. In addition to the border inspections, quarantines and testing, they included integration of data between the country’s National Health Insurance Administration and National Immigration Agency, so authorities, and later hospitals, could identify any patient who had recently traveled to China, Hong Kong, or Macau.

The steps also included:

  • An escalating series of travel restrictions, eventually including suspension of most passenger flights from Taiwan to China, as well as a suspension of tours to Hong Kong or Macau.
  • Use of government-issued cell phones to monitor quarantined individuals.
  • Fines for individuals breaking the 14-day home quarantine.
  • Fines for incoming travelers who failed to provide accurate health information.
  • Fines for disseminating false information or rumors about the epidemic.
  • Fines and jail sentences for profiteering on disease-prevention products.
  • Designation of military camps and other government facilities for quarantine.
  • Nationwide disinfection of universities, colleges, and public spaces around schools.

The government also took aggressive action to ensure adequate supplies of surgical masks, including stepped-up manufacturing, export bans, price limits, and a limit of one to three masks per purchase.

The JAMA authors noted that government officials issued daily press briefings to educate the public about the outbreak. Communication efforts also included public service announcements by Taiwan Vice President Chen Chien-jen, a trained epidemiologist.

A poll taken in Taiwan on Feb. 17 and 18 indicated high approval ratings for officials’ response to the crisis.

The JAMA authors also noted some “challenges” in the government’s response. For example, most real-time public communication was in Mandarin Chinese and sign language, leaving out non-Taiwanese citizens in the country. And the cruise ship Diamond Princess, later found to have infections on board, was allowed to dock near Taipei and disembark passengers. There are also questions about whether similar policies can be sustained through the end of a pandemic.

Still, “well-trained and experienced teams of officials were quick to recognize the crisis and activated emergency management structures to address the emerging outbreak,” the JAMA authors wrote. “Taiwan is an example of how a society can respond quickly to a crisis and protect the interests of its citizens.”

One noteworthy difference in the speedy response to recognition of a novel coronavirus in Taiwan, compared to recognition of the same novel coronavirus in the United States, was the fast availability of clinical laboratory tests for COVID-19 in Taiwan.

Pathologists and clinical laboratory professionals here in the US are frustrated that their skills and talents at developing and validating new assays on an accelerated timeline were not acknowledged and leveraged by government officials as they decided how to respond to the emergence of the novel coronavirus now called SARS-CoV-2. 

—Stephen Beale

Related Information:

Taiwan CDC Press Releases about COVID-19

Is Taiwan’s Impressive Response to COVID-19 Possible in Canada?

Taiwan Has Been Shut Out of Global Health Discussions. Its Participation Could Have Saved Lives

Taiwan Has Only 77 Coronavirus Cases. Its Response to the Crisis Shows That Swift Action and Widespread Healthcare Can Prevent an Outbreak

What the U.S. Can Learn from Taiwan’s Response to Coronavirus

What Taiwan Can Teach the World on Fighting the Coronavirus

As Coronavirus Hot Spots Grow, Taiwan Beating the Odds Against COVID-19

They’ve Contained the Coronavirus. Here’s How

How Many Tests for COVID-19 Are Being Performed Around the World?

Excessive $48,329 Charge for California Patient’s Outpatient Clinical Laboratory Testing Calls Attention to Chargemaster Rates and New CMS Price Transparency Rule

Studies show medical laboratories may be particularly hit by adjustments to hospital chargemasters as hospitals prepare to comply with Medicare’s New Transparency Rule

Recently, Kaiser Health News (KHN) published a story about a $48,329 bill for allergy testing that cast a spotlight on hospital chargemaster rates just as healthcare providers are preparing to publish their prices online to comply with a new Centers for Medicare and Medicaid Services (CMS) rule aimed at increasing pricing transparency in healthcare. The rule goes into effect January 1, 2019.

The patient—a Eureka, Calif., resident with a persistent rash—had received an invoice for more than $3000 from her in-network provider.

Though this type of allergy skin-patch testing is usually performed in an outpatient setting by a trained professional, such as an allergist or dermatologist, the patient elected to have the testing performed at Stanford Health Care (Stanford), a respected academic medical system with multiple hospitals, outpatient services, and physician practices.

The patient’s insurance plan, Anthem Blue Cross (Anthem), paid $11,376 of the $48,329 amount billed by Stanford Health Care, which was the rate negotiated between the insurer and Stanford, Becker’s Healthcare reported. The patient ultimately paid $1,561 out-of-pocket.

So, where did that $48,329 in total charges come from? Experts pointed to the provider’s chargemaster. A chargemaster (AKA, charge description master or CDM) lists a hospital’s prices for services, suppliers and procedures, and is used by providers to create a patient’s bill, according to California’s Office of Statewide Health Planning and Development (OSHPD).

Chargemasters note high prices beyond hospitals’ costs and may be considered jumping off points for hospitals to use in invoicing payers and patients, RevCycleIntelligence explained.

Hospital representatives will negotiate with insurance companies, asking them to pay a discounted rate off the chargemaster list. A patient with health insurance accesses care at that negotiated rate and perhaps has responsibility for a share of that amount as well.

However, an out-of-network patient, uninsured person, or cash customer who receives care will likely be billed the full chargemaster rate.

In a statement to KHN, Stanford explained that the California woman’s care was customized and, therefore, costly: “We conducted a comprehensive evaluation of the patient and her environmental exposures and meticulously selected appropriate allergens, which required obtaining and preparing putative allergens on an individual basis.”

Johns Hopkins researchers Ge Bai, PhD, CPA (left), and Gerard Anderson, PhD (right), authored a study published in Health Affairs that shows “Hospitals on average charged more than 20 times their own costs in 2013 in their CT scan and anesthesiology departments.” Hospitals with clinical laboratory outreach programs will want to consider how their patients may respond as new federal price transparency requirements make it easier for patients to see medical laboratory test prices in advance of service. (Photo copyright: Johns Hopkins University.)

Now is a Good Time for Clinical Laboratories to Make Chargemaster Changes

Some organizations, such as the Healthcare Financial Management Association (HFMA), are calling for chargemaster adjustments as part of a comprehensive plan to improve transparency and lower healthcare costs. This falls in line with the new CMS rule requiring hospitals to post prices online starting Jan.1, 2019.

In fact, hospital medical laboratories, which cannot distinguish their services from competitors, may be impacted by the new CMS rule perhaps more than other services, the HFMA analysis warned.

“The initial impact for healthcare organizations, if they have not already experienced it, will be on commoditized services such as [clinical] lab and imaging. Consumers do not differentiate between high and low quality on a commoditized service the same way a physician might, which means cost plays a larger role in consumers’ decision making.” That’s according to Nicholas Malenka, Senior Consultant, GE Healthcare Partners, and author of the HFMA report. He advises providers to do chargemaster adjustments that relate charges to costs of services, competitors’ charges, and national data.

Medical laboratory leaders also may want to take another look at the opportunities and risks for labs suggested in an earlier Dark Daily e-briefing on the Medicare requirement. (See, “Latest Push by CMS for Increased Price Transparency Highlights Opportunities and Risks for Clinical Laboratories, Pathology Groups,” August 8, 2018.)

Are Chargemaster Charges Truly Excessive? Johns Hopkins Researchers Say ‘Yes!’

Most hospitals with 50 beds or more have a charge-to-cost ratio of 4.32. In other words, $432 is charged when the actual cost of a service is $100, according a study conducted by Johns Hopkins University and published in Health Affairs.

The researchers also noted in a news release about their findings titled, “Hospitals Charge More than 20 Times Cost on Some Procedures to Maximize Revenue,” that:

  • Charge-to-cost ratios range from 1.8 for routine inpatient care to 28.5 for a CT scan; and,
  • Hospitals with $100 in CT costs may charge an uninsured patient or out-of-network patient $2,850 for the service.

“Hospitals apparently markup higher in the departments with more complex services because it is more difficult for patients to compare prices in these departments,” lead author Ge Bai, PhD, CPA, Associate Professor at Johns Hopkins Carey Business School, noted in the news release.

“(The bills for high charges) affect uninsured and out-of-network patients, auto insurers, and casualty and workers’ compensation insurers. The high charges have led to personal bankruptcy, avoidance of needed medical services, and much higher insurance premiums,” co-author Gerard Anderson, PhD, Professor of Health Policy and Management at Johns Hopkins Bloomberg School of Public Health, stated in the news release.

Legal Issues Possible for Hospitals, Medical Laboratories, Other Providers

Still another study published in the American Journal of Managed Care (AJMC) explored the legality of “surprising” uninsured and out-of-network patients with bills at the chargemaster rates. It found that contract law supports market-negotiated rates—not chargemaster rates that do not reflect actual costs or the market.

“Patients and payers should know that they are under no obligation to pay surprise bills containing chargemaster rates, and state attorneys generally can use the law to prevent providers from pursing chargemaster-related collection efforts against patients,” the researchers wrote.

Labs Need to Get Involved

Clinical laboratory leaders in hospitals and health systems are advised to reach out to hospital chargemaster coordinators to ensure the chargemaster, as it relates to the lab, is inclusive, accurate, and in sync with competitive market data. Independent medical laboratories may want to similarly check their chargemasters to see how their lab test prices compare to the prices charged by other labs serving the same community.

—Donna Marie Pocius

Related Information:

That’s a Lot of Scratch: The $48,329 Allergy Test

Allergy Tests

Six Things to Know About a Woman’s $48K Allergy Test

The Role of the Hospital Chargemaster in Revenue Cycle Management

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Hospitals Charge More than 20 Times Costs on Some Procedures to Maximize Revenue

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