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Clinical Laboratories and Pathology Groups

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Singapore University Researchers Unveil Portable $1 Point-of-Care Testing That Speedily Tests for Multiple Diseases

Hand-held tests developed from the work of the NUS BIGHEART team could help caregivers in remote areas diagnose disease quickly, accurately, and inexpensively

There is great demand in Asia for diagnostic tests that are cheap, accurate, and have a fast time to answer. Especially in Asia’s remote and mobile clinics where caregivers need immediate access to clinical laboratory test results at the time of patients’ visits.

Researchers at the National University of Singapore (NUS) have unveiled just such a test that could eventually be performed at the point-of-care using smartphones for disease detection and analysis.

Dark Daily has reported many times on new clinical laboratory tests that use smartphones in past e-briefings. They are among the most significant developments to impact the pathology industry in our times.

According to the NUS researchers, their test can screen, detect, and analyze multiple diseases through a nucleic acid test platform. Best of all, the test costs less than $1, operates at room temperature, and takes about 30 minutes to an hour to uncover diseases.

NUS published the study in Nature Communications.

Researchers Aim to Simplify Complex Lab Testing

“Rapid, visual detection of pathogen nucleic acids has broad applications in infection management,” the researchers wrote in their study. They found that a screening device using molecular agents to detect disease-specific molecules has implications for a range of diseases: from Zika and Ebola to hepatitis, dengue, malaria, and cancers, according to a news release.

The NUS researchers dubbed their creation enVision (enzyme-assisted nanocomplexes for visual identification of nucleic acids).

2018-0918-enVision-graphic

The enVision microfluidic system (above) consists of a series of enzyme–DNA nanostructures to enable target recognition, target-independent signaling, and visual detection. The common cartridge houses the universal signaling nanostructures, which are immobilized on embedded membranes, for target-independent signaling and visual detection. The platform is designed to complement the modular enVision workflow. (Image and caption copyright: National University of Singapore.)

“Conventional technologies—such as tests that rely on polymerase chain reaction to amplify and detect specific DNA molecules—require bulky and expensive equipment, as well as trained personnel to operate these machines. With enVision, we are essentially bringing the clinical laboratory to the patient,” said Nicholas Ho, PhD, an NUS Biomedical Institute for Global Health Research and Technology (BIGHEART) Research Fellow and study co-first author, in the news release.

Shao-Lab-NUS-BIGHEART-enVision

NUS BIGHEART researchers include Assistant Professor Huilin Shao, PhD, at center holding the enVision cartridge, with Nicholas Ho, PhD, to the left and Lim Geok Soon, PhD, to the right. They tested the performance of enVision on human papillomavirus (HPV), a sexually transmitted infection and primary cause of cervical cancer. HPV has more than 100 subtypes of which 15 are malignant. The researchers studied samples from 35 NUS patients. (Photo copyright: National University of Singapore.)

“HPV is a global epidemic. While mostly benign, some of these infections can progress to cause deadly cervical cancer,” they wrote in Nature Communications. “Point-of-care testing that can distinguish the infection subtypes, and be performed at the patient level, could bring tremendous opportunities for patient stratification and accessible monitoring and is associated with better health outcomes.”

NUS researchers found that the enVision platform had a 95% accuracy rate in screening for HPV, as compared to conventional lab testing, according to Singapore’s Straits Times.

“While laboratory tests can detect one to two HPV strains, the kit is able to detect over 10 strains and has better coverage for each strain,” said Assistant Professor Huilin Shao, PhD, NUS BIGHEART, in the Straits Time article.

How Does it Work? 

The test’s steps, according to an NUS News article, include:

  • The tiny plastic chip holds the sample (blood, urine, or saliva) for analysis, along with a DNA “molecular machine” to recognize genetic sequences;
  • This sample is channeled to a common signal cartridge containing another DNA molecular machine;
  • Visual signals are evidence of disease-specific molecules and an assay turns from colorless to brown if disease is present;
  • Further analysis, potentially using a smartphone app, could delve into the extent of an infection.

“The first machine is a recognition nanostructure which detects specific genetic sequences that relate to different kinds of diseases—the pathogens, bacteria, or viruses for example—and produces a signal,” Ho told NUS News. “It pairs up with what we call an amplifier nanostructure which takes that signal, amplifies it and turns it into a color read-out.”

The researchers note that more studies on other diseases are needed before marketing of the test kit, which they developed over 18 months. The NUS team also sees opportunities to enable better image capabilities and analysis algorithms through smartphone applications (apps).

“Large cohort studies on the detection of pathogen nucleic acids across a spectrum of diseases (e.g., other infections, cancers, inflammatory disorders) using various biological specimens (e.g., tissue, blood, urine) could be performed to validate the clinical utility of the enVision technology for diverse visual detection,” they concluded in Nature Communications.

As healthcare resources become limited and populations continue to grow, studies into portable, low-cost testing become more critical. Clinical laboratories performing tests in rural, outlying areas of the world will especially benefit from the work of researchers like the NUS BIGHEART team at University of Singapore.

—Donna Marie Pocius

Related Information:

New Test Kit Invented by NUS Researchers Enables Quick, Accurate, and Inexpensive Screening of Diseases

Cheap Portable Screening Kit for Multiple Diseases in the Works

Visual and Modular Detection of Pathogen Nucleic Acids with Enzyme-DNA Molecular Complexes

72 Cents Test Screens for Diseases in Less Than an Hour

enVisioning Future Disease Diagnostics

New Fast Inexpensive Mobile Device Accurately Identifies Healthcare-acquired Infections and Communicates Findings to Doctors’ Smartphones and Portable Computers

Multi-channel Smartphone Spectrometer Enables Clinical Laboratory Testing Quickly and Accurately in Remote Regions

Researchers at New York Genome Center and Columbia University Discover Why Certain Genetic Mutations Cause Disease in Some Individuals and Not in Others

Determining the reason why people with similar genetic makeups can have different risk levels for disease could help scientists develop more accurate tools that clinical laboratories and pathology groups can use for diagnosis and prognosis

It’s been a big question for genetic scientists that now may have part of an answer. Why do individuals who carry identical gene mutations for a particular disease often experience different disease symptoms and severity? The question relates to variable penetrance and a new study suggests some reasons why this is often true.

Researchers at the New York Genome Center (NYGC) and the Columbia University Department of Systems Biology performed the study by examining the important implications of a genetic irregularity known as variable penetrance in human disease.

The researchers published their findings in the scientific journal Nature Genetics.

Disease Risk Determined by Combination of Coding and Regulatory Gene Variants

The phenomenon of variable penetrance refers to the severity of the effects of disease-causing variants and how they may differ among individuals who carry those genetic variants. Variable penetrance has proven to be a challenge when predicting the severity of a disease even when a strong genetic association is present.

The researchers developed a hypothesis for modified penetrance, where genetic variants that regulate gene activity can alter the disease risk caused by protein-coding gene variants. The study links modified penetrance to specific diseases at the genome level, which could help predict the severity of some diseases.

“Our findings suggest that a person’s disease risk is potentially determined by a combination of their regulatory and coding variants, and not just one or the other,” stated Tuuli Lappalainen, PhD, Group Leader at the New York Genome Center and Assistant Professor at Columbia University, in a news release. “Most previous studies have focused on either looking for coding variants or regulatory variants that affect disease in these individuals or potentially looking at common variants that could affect disease. We have merged these two fields into one clear hypothesis that uses data from both of them, which was fairly unheard of before.”

NYGC-Columbia-University-Tuuli-Lappalainen-PhD-Stephane-Castel-PhD

Tuuli Lappalainen, PhD (top photo left), and Stephane Castel, PhD (bottom photo left), of the New York Genome Center (NYGC) and Columbia University, co-led the new study. The hypothesis of the study is illustrated here with an example in which an individual is heterozygous for both a regulatory variant and a pathogenic coding variant. The two possible haplotype configurations would result in either decreased penetrance of the coding variant, if it was on the lower-expressed haplotype, or increased penetrance of the coding variant, if it was on the higher-expressed haplotype. (Image and caption copyrights: NYGC.)

The researchers first tested their modified penetrance hypothesis by analyzing data from the Genotype-Tissue Expression (GTEx) Project, a database created by the National Institutes of Health (NIH) to increase our understanding of how genes contribute to diseases. By evaluating the interactions of regulatory and coding variants in people without severe genetic disorders, they found an enrichment of haplotypes, a group of alleles of different genes on a single chromosome that are closely enough linked to be inherited.

Haplotypes protect against disease by decreasing the penetrance of coding variants associated with disease development. Because the researchers were looking at individuals without severe genetic diseases, the presence of enhanced haplotypes was expected.

The scientists then tested their hypothesis of modified penetrance in a disease-specific population of patients. They analyzed data from The Cancer Genome Atlas (TCGA), a database complied by the NIH, along with information from the Simons Simplex Collection (SSC).

The SSC is a project of the Simons Foundation Autism Research Initiative (SFARI) that has a permanent repository of genetic samples from 2,600 families, each of which has one child affected with autism spectrum disorder (ASD), and unaffected parents and siblings.

In both the cancer patients and individuals with ASD, the researchers discovered an enrichment of haplotypes forecasted to increase the penetrance of coding variants associated with the two disorders.

The team then designed an experiment using CRISPR/Cas9 genome editing technology to test their modified penetrance hypothesis. For this portion of the experiment, they chose a coding variant associated with Birt-Hogg-Dube´ Syndrome, a rare genetic disorder that can cause susceptibility to certain types of tumors.

By editing the single-nucleotide polymorphism (SNP) into a cell line on different haplotypes with a regulatory variant, they were able to prove that the regulatory variant did modify the effect of the coding disease-causing variant.

“Now that we have demonstrated a mechanism for modified penetrance, the long-term goal of the research is better prediction of whether an individual is going to have a disease using their genetic data by integrating the regulatory and coding variants,” said Lappalainen in the news release.

New Tools for More Precise Diagnosis/Prognosis

This discovery should help provide a framework for scientists to test disease SNPs to assess if they could be affected by modified penetrance, which could help medical professionals better predict an individual’s potential risk of disease development and severity.

“In the future, studies of the genetic causes of severe diseases should take into account this idea that regulatory variants need to be considered alongside coding variants,” said Stephane Castel, PhD, Senior Research Fellow at NYGC, in the news release. “This should eventually lead to a more fine-grained understanding of the risk of coding variants associated with disease.”

Of course, such test are years away from clinical use. However, the NYGC/Columbia University study highlights how much more precise diagnosis/prognosis could become with these types of tools.

Should further research validate these early insights, clinical laboratories could soon have new genetic tests that better predict and identify which health outcomes patients should expect based on their unique genetic makeup.

—JP Schlingman

Related Information:

Research: Molecular Mechanism Explains Why Genetic Mutations Affect Some People

Modified Penetrance of Coding Variants by Cis-regulatory Variation Contributes to Disease Risk

New Study Explains Why Genetic Mutations Cause Disease in Some People but Not in Others

Dr. Tuuli Lappalainen Awarded Major NIH Grant to Study Genomic Phenomenon Variable Penetrance

Rutgers University Researchers Develop Desktop Venipuncture Robot Capable of Drawing Blood Samples and Rendering Analyses Outside of Medical Laboratories

Robotics combined with microfluidic systems continue to push traditional clinical laboratory testing and procedures toward physician’s offices and other point-of-care settings

Researchers at Rutgers University have developed a new venipuncture robot that can not only draw blood and perform medical laboratory tests, but also provide immediate analyses of blood samples at point-of-care locations, such as clinics, private doctor’s offices, and rural environments.

It’s a development that could give clinical laboratories new opportunities to support physicians. But, should blood labs, phlebotomists, and medical technologists feel threatened by this development?

“This device represents the holy grail in blood testing technology,” said Martin L. Yarmush, MD, PhD, Bioengineer and Translational Scientist, Professor in the Department of Biomedical Engineering at Rutgers University, and senior author of the study, in a news release. “Integrating miniaturized robotic and microfluidic (lab-on-a-chip) systems, this technology combines the breadth and accuracy of traditional blood drawing and laboratory testing with the speed and convenience of point-of-care testing.”

Dark Daily has reported on several “lab-on-a-chip” systems (or other types of “lab-on-a-” test devices) in past e-briefings. However, those devices for the most part are administered as part of procedures performed at clinical laboratories. Now comes a device that could make it feasible for doctors to perform some traditional clinical laboratory procedures in-office, while patients are still present. Such an innovation, if embraced, could impact clinical lab workflows and revenues.

The Rutgers researchers published their findings in Technology, an online scientific journal.

Rutgers Researchers Goal: ‘Nobody Touches a Needle’

Diagnostic blood testing is the most commonly performed medical test in the world, and the results influence most healthcare treatment decision-making. Traditionally, the success rate of manually drawing blood samples depends upon the skill of the clinician and the physiology of the patient. By locating the blood vessels before the venipuncture, the researchers expect their device to prevent stressful multiple blood-draw attempts, bruising, and injuries to arm nerves.

Martin-Yarmush-MD-PhD

“There are about two billion blood draws done in the U.S. alone each year,” Martin L. Yarmush, MD, PhD (above), Bioengineer and Translational Scientist at Rutgers University and senior author of the study, told Smithsonian Magazine. “It is the number one patient injury procedure. It’s also the number one clinical injury procedure. The device is meant to take over such that nobody touches a needle.” (Photo copyright: Rutgers University.)

The end-to-end tabletop device includes an image-guided robot for extracting blood samples from veins, a sample-handling module, and a centrifuge-based blood analyzer. The venipuncture robot works by first utilizing a combination of near-infrared and ultrasound imaging to locate blood vessels in a patient. The device then creates a 3D image of the vessels before sticking the patient with a needle to collect a blood sample.

The robot potentially could make it easier and faster to obtain blood samples from patients, particularly for patients where traditional blood draws can be difficult, such as children and the elderly.

“We wanted to create a device that would perform venipuncture procedure with little to no human involvement, thus minimizing human error,” Yarmush told Smithsonian Magazine. “As such, our automated device requires little to no training, allowing it to be easily adapted to any clinical environment.”
Rutgers-University-blood-test-robot

The Rutgers venipuncture robot (above) contains a centrifuge-based analyzer capable of performing instant blood analyses, such as white blood cell counts and hemoglobin measurements. Immediate readings could mean that medical practices won’t need to send blood samples to a clinical laboratory for analysis. (Image copyright: Rutgers University/Smithsonian Magazine.)

Protecting Phlebotomists as well as Patients

The researchers also hope their robot could help prevent accidental needle sticks to phlebotomists. According to a study published in Mayo Clinic Proceedings titled, “Phlebotomists at Risk,” a hard-working phlebotomist may perform as many as 10,000 venipunctures annually. The median needlestick injury rate is about 1 per 10,000 venipunctures, so a dedicated phlebotomist could experience one accidental percutaneous blood exposure per year.

The researchers tested their prototype on “tissue-like” artificial arms containing tubes filled with blood-like substances. They hope to begin performing clinical trials on the venipuncture robot within the next year and aspire to establish other uses for the device.

“When designing the system, our focus was on creating a modular and expandable device,” Max Balter, PhD, stated in the news release. Balter led the study while a graduate research fellow at Rutgers. He is currently a senior research and development engineer at Medtronic. “With our relatively simple chip design and analysis techniques, the device can be extended to incorporate a broader panel of tests in the future.”

Such a device could provide valuable and rapid test results in emergency settings such as ambulances, emergency departments, and army medical facilities. The robot also would be a boon to rural/remote settings located far from a clinical lab, as well as regions that suffer from a shortage of trained medical personnel and critical resources.

A cost-effective, reliable phlebotomy robot could be a valuable asset for clinical laboratories in the future as well. However, were such a device to find a place in clinical care, it could reduce the demand for phlebotomists. It could also accelerate the trend of moving traditional clinical laboratory testing to doctor’s offices, clinics, and remote point-of-care settings.

—JP Schlingman

Related Information:

Automated Robotic Device for Faster Blood Testing

A Robot May One Day Draw Your Blood

Automated End-to-end Blood Testing at the Point-of-care: Integration of Robotic Phlebotomy with Downstream Sample Processing

Phlebotomists at Risk

Rutgers Researchers Develop Automated Robotic Device for Faster Blood Testing

Duke University Study Suggests the Human Body Starves Gut Bacteria to Produce Beneficial Results

Human microbiota is linked to many diseases but could hold the key for advanced clinical laboratory tests and targeted precision medicine therapies

Study of the human microbiome continues to provide understanding and knowledge regarding gut bacteria and its many benefits, and incites development into new clinical laboratory tests. However, a new study reveals that our bodies might also put gut bacteria under stress leading to better health.

Traditionally, scientists believe the human gut is a hospitable environment that allows bacteria to thrive. However, microbiologists may be interested in a study by Duke University School of Medicine (Duke) that suggests the relationship between humans and their microbiomes may be adversarial as well.

In fact, the study found that human hosts are starving their microbes of nutrients and forcing them to compete for food for the benefit of the host.

“There appears to be a natural pecking order to the bacteria and us,” noted Lawrence A. David, PhD, Assistant Professor, Department of Molecular Genetics and Microbiology at Duke University School of Medicine, in an article Duke posted on Phys.org. “In a way it’s not surprising that we, the host, should hold more of the cards.”

Duke researchers published the results of their study in Nature Microbiology, an online peer-reviewed scientific journal.

Could Nitrogen Impact Gut Bacteria?

The human microbiome consists of hundreds of different types of bacteria and other various tiny organisms, such as viruses and fungi. When combined, the microbes in the human gut weigh approximately three pounds or about the same as the brain.

The theory behind Duke’s study was that the human microbiome is an ecosystem comprised of various entities that compete for resources, and which are often constricted by nutrients, such as nitrogen or phosphorus.

To perform the study, Aspen Reese, PhD, a PhD candidate at Duke during the study and now a Junior Fellow researcher at Harvard University, procured stool samples from more than 30 types of mammals. She then ground the individual samples and tabulated the number of nitrogen and carbon atoms contained within those samples.

 

The animals used for the study included wild zebras, giraffes and elephants from Kenya, domestic sheep, cattle and horses from New Jersey, and humans from North Carolina. The graphic above shows how “carbon-to-nitrogen ratios in poop vary between animals as a result of diet and physiology. These ratios also govern the abundance of microbes in their guts.” (Image copyright: Aspen Reese/Harvard University.)

Reese discovered that the bacteria in the human gut had access to only one nitrogen atom for every 10 carbon atoms. The bacteria in other mammals’ guts had access to one nitrogen atom for every four carbon atoms. The question arose: Could nitrogen levels in the human gut impact the microbiome?

Reese performed tests on mice to determine if nitrogen levels could help regulate the microbiome. She fed the mice a diet packed with protein, which naturally contains a large amount of nitrogen. When she increased the amount of protein fed to the mice, the amount of their gut bacteria also increased. Reese then injected nitrogen directly into the bloodstream of the mice and found that some of that nitrogen ended up in their gut bacteria.

This discovery suggests the host can help save microbes in the gut by secreting nitrogen through the cells.

“Our findings support the idea that we’ve evolved a way to keep our bacteria on a leash by leaving them starving for nitrogen,” David noted on Phys.org. “It also explains why the Western diet might be bad for us. When people eat too much protein, it swamps the host’s ability to take up that nitrogen in the small intestine, and more of it ends up making its way to the large intestine, eliminating our ability to control our microbial communities.” (Photo copyright: Duke University School of Medicine.)

Antibiotics and Gut Bacteria

The team also performed a previous study regarding the effects of antibiotics on gut bacteria, which they published in June on eLife, an online open-access journal.

In that study, the researchers gave mice a five-day treatment of antibiotics. By analyzing their stool samples daily, the scientists discovered that many of the energy sources needed by microbes in the gut accumulated as bacteria was depleted. Some species of valuable gut bacteria are eliminated by antibiotics and may never return.

The researchers found that the mice had to eat each other’s stools in order for those essential microbes to return.

“People probably won’t want to do that,” David told Phys.org.

The trillions of microbes that reside in the human gut help manage almost every function of the human body. Poor gut health can contribute to a wide variety of health problems, including allergies, arthritis, dementia, diabetes, cardiovascular disease, leaky gut syndrome, and some cancers and autoimmune diseases.

Factors such as diet, sleep habits, stress levels, and the number of bacteria an individual is exposed to on a regular basis can negatively affect the microbiome.

Continuing research into the mysteries contained in the human microbiome provide valuable data about our gut bacteria. This type of information could eventually help microbiologists and clinical laboratory professionals more accurately identify diseases and health conditions and guide physicians to appropriate, and possibly targeted, precision medicine therapies for patients.

—JP Schlingman

 

Related Information:

Our Microbes Are Starving, and That’s a Good Thing

Scientists Reveal How Gut Microbes ‘Recover’ after Antibiotic Treatment

How and Why Our Bodies Starve Gut Bacteria

Loss of Microbial Gut Diversity a Threat to Health?

Microbial Nitrogen Limitation in the Mammalian Large Intestine

How Many Cells Are in the Human Body—And How Many Microbes?

Mayo Clinic Researchers Find Some Bacteria Derail Weight Loss, Suggest Analysis of Individuals’ Microbiomes; a Clinical Lab Test Could Help Millions Fight Obesity

University of Illinois Study Concludes Regular Physical Exercise Improves Human Microbiome; Might Be Useful Component of New Treatment Regimens for Cancer and Other Chronic Diseases

Researchers in Two Separate Studies Discover Gut Microbiome Can Affect Efficacy of Certain Cancer Drugs; Will Findings Lead to a New Clinical Laboratory Test?

More Big Companies Engage Health Networks Directly to Cover Their Employees’ Healthcare: Should Medical Laboratories Be Talking to Self-Insuring Employers?

By negotiating directly with healthcare systems employers garner cost savings, while creating opportunities for clinical laboratories willing to be flexible about claims and reimbursement

It’s a healthcare trend called “direct contracting” and it is the latest method that self-insuring employers are using to better manage the cost of their health benefits plan, while maintaining access and quality for their employees. The interesting thing about direct contracting is that it might be a strategy that could work for innovative regional clinical laboratories to negotiate a place for themselves in that employer’s provider network.

Healthcare costs continue to skyrocket in the United States, and in response, many large companies are providing healthcare services to their employees by working directly with health networks and other organizations, instead of using third-party administrators (TPAs) of insurance plans to create healthcare benefits packages for their employees.

This can provide clinical laboratories and anatomic pathology groups with opportunities to create revenue and further outreach into their communities. Astute lab leaders may want to consider meeting with the decision-makers at large companies in their areas and develop strategies for working together directly. Human resources managers may be interested in the benefits of working directly with medical laboratories.

Employers Already Engaged with Health Networks for Provider Services

Self-insuring is not a new concept. In a direct contracting relationship, the employer skips the TPA in hopes of achieving cost savings. Sometimes the direct contract is for specific services that employees need most often, or they can be designed to cover the entire spectrum of services available to employees.

Many companies have already engaged in direct contracting for healthcare services. Among them are: Cisco Systems, Boeing, Intel, Walmart, and Whole Foods. Amazon, JP Morgan Chase, and Berkshire Hathaway also have announced a joint agreement to self-insure their employees, which Dark Daily reported in June. (See, “Six New Jersey Hospitals and Several Major Corporations to Self-Insure Their Million+ Employees; Trend Could Impact How Local Clinical Laboratories Get Paid,” June 11, 2018.)

Cisco has negotiated a direct healthcare agreement with Stanford Health System. Stanford operates a clinic at the Cisco campus, so that the primary care doctor is a member of the community within the company.

“I’m in their space. I’m actually where they work. I’m a bit of a village doc,” Larry Kwan, MD (above), a doctor of internal medicine with Stanford Health Care, told Reuters about his role in the Stanford clinic at the Cisco campus. About 1,000 Cisco employees are enrolled in the Stanford plan. Katelyn Johnson, Integrated Health Manager at Cisco Systems, says it’s a program that requires a more active approach from companies than traditional health benefits plans. (Photo copyrights: Stanford Health Care.)

Boeing, too, has explored direct contracting in a program where the company negotiated directly with hospitals in four different states. The direct contracts have resulted in cost savings and cover some 15,000 employees plus their families. Some of those cost savings have come from things like getting doctors to prescribe generic drugs.

Intel also has a similar program, covering around 38,000 employees and their families. They have found success in managing chronic conditions like diabetes. Technology, such as video-conferencing, also has helped lower costs and improve retention.

Even health networks are getting into the game. One recent example is the Healthcare Transformation Consortium (HTC), a six-hospital healthcare systems in New Jersey that formed to self-insure and provide direct healthcare coverage for their employees.

Companies may gain some cost savings from directly negotiating, but there are gains for the health systems as well. In a deal with Whole Foods in 2016, Adventist Health System gained a new set of skills that they plan to use in negotiating similar deals with other employers.

“We have a little bit more flexibility as a health system to design around what Whole Foods defines as quality, or what Whole Foods defines as patient satisfaction, which is sometimes different than the traditional definitions,” Arby Nahapetian, MD, regional chief medical officer and SVP at Adventist-Southern California told Modern Healthcare.

Signs Point to Trend Continuing

The Healthcare Transformation Consortium in New Jersey, along with the joint agreement between Amazon, JP Morgan Chase, and Berkshire Hathaway, are examples of what the future is likely to hold. The more these kinds of collaborations and direct contracts result in both cost savings and patient satisfaction, the more companies will likely consider direct healthcare contracts.

Hospital-based and independent laboratories may want to consider meeting with the larger employers in their service regions and explain to the HR benefits managers how better utilization of selected lab tests could improve patient outcomes and contribute to better managing costs.

After all, employers tell health insurance companies what they want to cover with their health benefits plans. So, educating the employers’ HR teams about the true value of clinical laboratory tests could be a winning strategy for labs willing to take the time to do this.

Dava Stewart

Related Information:

Fed Up with Rising Costs, Big US Firms Dig into Healthcare

Left Out of the Game: Health Systems Offer Direct-To-Employer Contracting to Eliminate Insurers

Six New Jersey Hospitals and Several Major Corporations to Self-Insure Their Million-plus Employees; Trend Could Impact How Local Clinical Laboratories Get Paid

 

Independent Clinical Laboratories in Maryland May Need to Step-up Outreach with Hospitals as New CMS Program Launches Jan. 1

Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them.

The Centers for Medicare and Medicaid Services (CMS) and the state of Maryland expect to save $1 billion by 2023 in expanding Maryland’s existing All-Payer Model—which focused only on inpatient services since 2014—to also include primary care physicians, skilled nursing facilities, independent clinical laboratories, and more non-hospital settings, according to a CMS statement.

Healthcare Finance notes that it represents “the first time, CMS is holding a state fully at risk for the total cost of care for Medicare beneficiaries.”

Value of Precision Medicine and Coordination of Care to Clinical Labs

“If a patient receives care at a [medical] laboratory outside of a hospital, Maryland hospitals would be looking at ways to coordinate the sharing of that freestanding laboratory information, so that the hospital can coordinate the care of that patient both within and outside the hospital setting,” Erin Cunningham, Communications Manager at MHA, told Dark Daily. Such a coordinating of efforts and sharing of clinical laboratory patient data should help promote precision medicine goals for patients engaged with physicians throughout Maryland’s healthcare networks.

The test of the new program—called the Total Cost of Care (TCOC) Model—also could be an indication that Medicare officials are intent on moving both inpatient and outpatient healthcare providers away from reimbursements based on fees-for-services.

CMS and the state of Maryland said TCOC gives diverse providers incentives to coordinate, center on patients, and save Medicare per capita costs of care each year.

“What they are really doing is tracking how effective we are at managing the quality and the costs of those particular patients that are managed by the physicians and the hospitals together,” Kevin Kelbly, VP and Chief Financial Officer at Carroll Hospital in Westminster, told the Carroll County Times. “They will have set up certain parameters. If we hit those parameters, there could be a shared savings opportunity between the hospitals and the providers,” he added. (Photo copyright: LifeBridge Health.)

The TCOC runs from 2019 through 2023, when it may be extended by officials for an additional five years.

How Does it Work?

The TCOC Model, like the earlier All-Payer Model, will limit Medicare’s costs in Maryland through a per capita, population-based payment, Healthcare Finance explained.

It includes three programs, including the:

  • Maryland Primary Care Program (MDPCP), designed to incentivize physician practices by giving additional per beneficiary, per month CMS payments, and incentives for physicians to reduce the number of patients hospitalize;
  • Care Redesign Program (CRP), which is a way for hospitals to make incentive payments to their partners in care. In essence, rewards may be given to providers that work efficiently with the hospital to improve quality of services; and,
  • Hospital Payment Program, a population-based payment model that reimburses Maryland hospitals annually for hospital services. CMS provides financial incentives to hospitals that succeed in value-based care and reducing unnecessary hospitalizations and readmissions.

CMS and Maryland officials also identified these six high-priority areas for population health improvement:

  • Substance-use disorder;
  • Diabetes;
  • Hypertension;
  • Obesity;
  • Smoking; and
  • Asthma.

“We are going to save about a billion dollars over the next five years, but we are also providing better quality healthcare. So it’s going to affect real people in Maryland, and it helps us keep the whole healthcare system from collapsing, quite frankly,” Maryland Gov. Larry Hogan, told the Carroll County Times.

OneCare in Vermont, Different Approach to One Payer

Maryland is not the only state to try an all-payer model. Vermont’s OneCare is a statewide accountable care organization (ACO) model involving the state’s largest payers: Medicare, Medicaid, and Blue Cross and Blue Shield of Vermont, Healthcare Dive pointed out. The program aims to increase the number of patients under risk-based contracting and, simultaneously, encourage providers to meet population health goals, a Commonwealth Fund report noted.

Both Maryland’s and Vermont’s efforts indicate that payment plans which include value-based incentives are no longer just theory. In some markets, fees-for-service payment models may be gone for good.

Clinical laboratory leaders may want to touch base with their colleagues in Maryland and Vermont to learn how labs in those states are engaging providers and performing under payment programs that, if successful, could replace existing Medicare payment models in other states.

—Donna Marie Pocius

 

Related Information:

Maryland’s Total Cost of Care Model

Maryland All-Payer Model Expands to Include Outpatient Services

Gov. Hogan Sees Maryland Model as Example for U.S. Healthcare

The Maryland Model

Gov. Larry Hogan, Federal Government Sign Maryland Model All-Payer Contract

CMS Expands Maryland’s All-Payer Program to Outpatient Services

Vermont’s Bold Experiment in Community Driven Healthcare Reform

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