Jan 26, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
Lack of Medicare or third-party payer coverage for most genetic screening tests in healthy adults is not discouraging development of new gene testing products
With the global anatomic pathology genetic testing market poised to reach $9.8 billion by 2025, clinical laboratories continue to develop new genetic screening tests (rather than diagnostic tests) intended to help physicians identify patients who carry inherited genetic mutations that could put them or their future children at higher risk for chronic disease, such as cancer.
This is a bit of a gamble since (with some exceptions) Medicare and many health insurers typically will not pay for predictive and presymptomatic genetic tests and services used to detect an undiagnosed disease or disease predisposition.
Nevertheless, Inkwood Research of Gurugram, India, predicts in its “Global Genetic Testing Market Forecast 2017-2024” report that aging populations throughout the world will be the driving force producing “enormous opportunities for the global genetic testing market.” The research firm anticipates this will result in a 9.93% increase in annual sales revenue during each of the next seven years.
Screening versus Diagnostic Testing Gains Popularity Among Patients, Physicians
Genetic diagnostic testing promises to accelerate the growth of precision medicine by guiding the diagnosis and treatment of cancer and other chronic diseases. However, genetic tests that “screen” healthy patients for predispositions to certain diseases also are gaining traction in the marketplace.
The US Food and Drug Administration (FDA) gave direct-to-consumer genetic screening testing a boost in April 2017 when it allowed marketing of 23andMe Personal Genome Service Genetic Health Risk tests for 10 inherited diseases or conditions, including:
· Parkinson’s Disease;
· Late-onset Alzheimer’s Disease;
· Celiac Disease; and
· other conditions.
“Consumers can now have direct access to certain genetic risk information,” Jeffrey Shuren, MD, Director of the FDA’s Center for Devices and Radiological Health, said in a press release. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
Robert Green, MD, MPH, a Professor of Medicine at Harvard Medical School, told NPR that consumers should have access to genetic information. However, they also need to understand its limitations.
“Some people really want this [genetic] information on their own, and others want it through their physician,” Green said. “Both those channels are legitimate. People should just be aware that this information is complicated.”
According to the Inkwood Research report, “The global genetic testing market is anticipated to grow from $4,614 million in 2016 to $9,806 million by 2025, at a CAGR [Compound Annual Growth Rate] of 9.93% between 2017 and 2025. The important driver increasing growth in the global genetic testing market is an aging population on the rise. The rising geriatric population is driving the global genetic testing market to a significant level.” (Caption and graphic copyright: Inkwood Research.)
· Cystic Fibrosis;
· Sickle Cell Disease; and
· Spinal Muscular Atrophy.
The genetic screening panel tests for the 22 heritable diseases cited by the American College of Obstetricians and Gynecologists (ACOG) in a Committee Opinion on genetic carrier screenings published by the ACOG in March 2017.
“The United States is truly a melting pot, and it no longer makes sense for physicians to assume genetic screening is appropriate for an individual based on presumed race or ethnicity,” Felicitas Lacbawan, MD, Executive Medical Director, Advanced Diagnostics, Quest Diagnostics, stated in a press release. “QHerit is designed for any woman and her partner, not just those in a specific, so-called high-risk ethnic or racial group.”
Genetic Screening in Primary Care Helps Assess Risk for Chronic Disease
Genetic diagnostic test developer Invitae (NYSE:NVTA) also points to growing evidence of the genetic screening test’s value to healthy individuals. In September 2017, Invitae presented initial findings at the National Society of Genetic Counselors 36th Annual Conference. The study showed a retrospective analysis of 120 patients tested with a proactive genetic screening panel for healthy adults had revealed medically significant findings for nearly one in five patients.
“Interest among otherwise healthy adults in using genetic information to understand their risk of disease conditions continues to grow each year, ” Robert Nussbaum, MD, Chief Medical Officer of Invitae, said in a press release. “These and other data show that interest is well-placed, with a substantial group of patients showing genetic variants associated with elevated risk of diseases like cancer where monitoring and early intervention can be helpful. Use of genetic screening in the primary care setting can assess risk to help shape individual screening plans. We are continually adding tools and resources that help reduce barriers to the widespread use of genetic information in mainstream medical practice.”
Routine Genetic Screening Could Become Norm, CDC Says
The Centers for Disease Control and Prevention (CDC) notes that newborn screening is “currently the largest public health genetics program in the world,” with more than four million babies screened at birth each year for 30 or more genetic conditions. In the CDC’s “Genomics and Health Impact Blog,” the agency continues to maintain a “cautionary attitude about personal genomic tests” beyond the newborn period, directing those considering direct-to-consumer laboratory testing, such as 23andMe and MyMedLab, to “think before you spit.”
Nonetheless, the CDC acknowledges routine genetic screening of healthy people could become the norm. However, others advise caution.
“To be sure, while the use of genome sequencing is promising in certain clinical scenarios, such as rare diseases and cancer, we do not think that whole genome sequencing in the general population is appropriate at this time,” Muin J. Khoury, PhD, MD, Director, Office of Public Health Genomics, CDC, wrote in a January 30, 2017, blog post. “We would not recommend its use outside research studies … But it is also becoming clearer that as science progresses, we are discovering more opportunities for using genetic screening of healthy individuals for preventing common diseases across the lifespan, outside of the newborn screening context.”
The impact on clinical laboratories and anatomic pathology groups should genetic screening become normalized should be clear: Labs will be tasked with performing these tests, and pathologists will be needed to interpret them and educate both physicians and patients on the findings.
Before that, however, genetic screening tests will need to be fully supported by government, and insurers, including Medicare, will have to agree to pay for them.
—Andrea Downing Peck
Related Information:
Global Genetic Testing Market Forecast 2017-2024
Carrier Screening for Genetic Conditions
Quest Diagnostics Launches QHerit, a Pan-Ethnic Genetic Screening Panel Aligned with New Medical Guidelines
Invitae Expands Test Menu for Proactive Genetic Testing in Healthy Adults
Invitae Highlighting New Research, Expanded Suite of Services at National Society of Genetic Counselors (NSGC) 36th Annual Conference
Consumer Genetic Testing: Think Before You Spit, 2017 Edition
Genetic Screening of Healthy Populations to Save Lives and Prevent Disease
FDA Allows Marketing of First Direct-to-Consumer Test that Provide Genetic Risk Information for Certain Conditions
FDA Approves Marketing of Consumer Genetic Tests for Some Conditions
Jan 24, 2018 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Because many Americans are ‘concerned’ about how they would pay an unexpected medical bill, they now are seeking upfront information about treatment costs and financing options
Clinical laboratories and anatomic pathology groups that depend on reliable sources of patient and test referrals are being impacted by a reduction in patients seeking care due to rising costs. Evidence continues to mount that high deductible health plans (HDHPs) and the overall rising cost of healthcare are straining Americans’ finances. This is causing them to delay payments, question treatment costs, and investigate payment options.
These trends underscore the need for clinical laboratories and pathology groups to have point-of-service collection strategies in place or risk declining revenues.
Study Highlights Increasing Consumer Healthcare Costs
JPMorgan Chase Institute’s Healthcare Out-of-pocket Spending Panel (JPMCI HOSP) recently studied the healthcare cost burden on 2.3-million de-identified Chase checking account holders aged 18 to 64. In a report titled, “Paying Out-of-Pocket: The Healthcare Spending of 2 Million US Families,” Chase noted the following key indicators that predict continued decline in healthcare revenues as patients’ costs increase:
· “A clear correlation exists between timing of healthcare payments and an account-holder’s ability to pay, with the largest payments taking place in the years and months with increased liquid assets. This finding emphasizes the clear link between a family’s financial health and their access to healthcare services. The report found a clear spike in payments during the months of March and April, when nearly 80% of tax filers receive tax refunds.
· “There is significant variation of out-of-pocket expenses among and within states, emphasizing the important role of states in shaping healthcare policy. Colorado families spent the most out of pocket, while families in Louisiana spent the most as a percent of income. California was among the lowest in terms of both raw dollar amounts and payments as a share of income. As part of this report, the JPMorgan Chase Institute has created online data visualization assets to illustrate these disparities and is providing downloadable payment data with information broken down to metro and county levels.
· “Out-of-pocket payments grew each year since 2013, but have remained a stable share of income, also known as “burden.” However, women, low-income families and pre-seniors are bearing the highest cost burden. The finding merits further study to establish whether these higher payments represent broader healthcare utilization or a clear expense burden for populations that can afford it the least.
· “Families that are in the top 10% of healthcare spend in a given year tend to remain the highest spenders on a year-over-year basis, emphasizing the substantial cost of chronic conditions and long-term healthcare needs.
· “Doctor, dental, and hospital payments accounted for more than half of out-of-pocket payments. While doctor payments accounted for the greatest volume of expenditures, dental and hospital payments were much more significant in terms of expense.”
In a news release, Diana Farrell, President and CEO, JPMorgan Chase Institute points out that, “The reality is that many American families don’t have the cash buffer to withstand the volatility created by out-of-pocket healthcare payments, and we need to better understand the correlation between financial health and physical health.”
The JPMorgan Chase Institute report, released September 19, 2017, came on the heels of the Kaiser Family Foundation (KFF)/Health Research and Education Trust (HRET) 2017 Employer Health Benefits Survey. This annual benchmark survey indicates workers on average now contribute $5,714 annually toward their family premiums, which average $18,764, and that employees at firms with fewer than 200 workers contribute as much as $6,814 on average.
The findings of this survey will be useful for those clinical laboratories and anatomic pathology groups developing business and clinical strategies to serve the growing numbers of patients who are covered by high-deductible health plans. The KFF/HRET survey highlighted the impact growth of HDHPs is having on workers:
· 81% of covered workers were in plans with an annual deductible, up from 59% in 2007 and 72% in 2012;
· The average deductible amounts for workers with employer-based coverage also is increasing steadily, rising from $616 in 2007 to $1,505 in 2017.
A JPMorgan Chase Institute study of family healthcare spending (not including premium payments) shows out-of-pocket costs varied widely in the US in 2016, both across and within states. Average spending ranged from a low of $596/year (California) to a high of $916/year (Colorado) in the 23 states where there are Chase retail banking branches. (Photo copyright: JPMorgan Chase Institute/Business Insider.)
Jay Bhatt, DO, President of KFF/HRET, and Senior Vice President and Chief Medical Officer at the American Hospital Association, notes that while some cost increases appear to be slowing, policymakers should continue seeking ways to reduce the burden on healthcare consumers.
“This year’s findings continue a positive run of a slowing in premium increases and in the growth of healthcare costs overall,” Bhatt states in a KFF news release. “As policymakers and providers continue to work to improve healthcare, ensuring it remains affordable and accessible is critically important.”
Importance of Providing Pricing and Payment Options
These results help explain why 42% of respondents to HealthFirst Financial’s Patient Survey stated they are “very concerned” or “concerned” about whether they could pay out-of-pocket medical expenses during the next two years. For example:
· More than half (53%) of those surveyed were concerned about how to pay a medical bill of less than $1,000;
· 35% indicated they would find paying a bill less than $500 difficult; and,
· 16% were worried about paying a bill less than $250.
Such financial worries will likely impact revenues at clinical laboratories as well as medical doctor’s offices. They also explain why 77% of healthcare consumers who participated in the HealthFirst Financial survey responded that it’s “important” or “very important” to know their costs before treatment.
Additionally, 53% of those surveyed want to discuss financing options before receiving care. However, according to the survey, just 18% of providers discussed payment options.
The study also found 40% of millennials would likely switch to a different provider offering low- or zero-interest financing for medical bills.
“These findings highlight a huge gap in what patients want and what hospitals, medical groups, and other healthcare providers are delivering,” KaLynn Gates, JD, President and Corporate Counsel of HealthFirst Financial, said in a news release. “Providers that care for the financial as well as clinical needs of their communities are much more likely to thrive in this era of rising out-of-pocket costs and growing competition for patients among traditional and non-traditional providers.”
Clinical Laboratories and Anatomic Pathology Groups Are Particularly Challenged
In “Hospitals, Pathology Groups, Clinical Labs Struggling to Collect Payments from Patients with High-Deductible Health Plans,” Dark Daily reported that clinical laboratories and pathology groups face particular challenges because, as patients become responsible for more of their healthcare bills, many labs are not prepared for collecting full payments from patients on HDHPs. Nor are they prepared for reduction in test ordering, as patients opt to not follow through with prescribed tests and treatments to save money.
These recent reports are another strong indicator of how critical it is for medical laboratories and pathology groups to develop tools and workflow processes for collecting payments upfront from patients with HDHPs.
—Andrea Downing Peck
Related Information:
Out-of-Pocket Healthcare Costs Straining Americans’ Finances
Paying Out-of-Pocket: The Healthcare Spending of 2 Million US Families
Here’s How Much People Spend on Healthcare by State
2017 Employer Health Benefits Survey
Premiums for Employer-Sponsored Family Health Coverage Rise Slowly for Sixth Straight Year, up 3%, but Averaging $18,764 in 2017
HealthFirst Financial Patient Survey: It’s Never Too Soon to Communicate Pricing and Payment Options
From Millennials to Boomers, Patients Want to Discuss Healthcare Pricing and Payment Options before Treatment
Hospitals, Pathology Groups, Clinical Labs Struggle to Collect Payments from Patients with High-Deductible Health Plans
Jan 22, 2018 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Meanwhile, some insurance payers are dropping coverage for certain medical treatments they consider “unnecessary,” leaving hospitals and their medical laboratories to wonder if they will be reimbursed for the tests they perform
Hospital-based medical laboratories and anatomic pathologists are well aware that the emergency department (ED) in their hospital is their single largest customer and that reporting test results within required turn-around times (TATs) is a non-stop battle. Thus, it will not be a surprise to learn that EDs provide nearly half of all hospital-related medical care in the US. That’s what a study by the University of Maryland School of Medicine (UMSOM) reports.
The UMSOM researchers claim their study, which was published in the International Journal for Health Services (IJHS), is the first ever to quantify the contribution EDs make to US healthcare. According to an UMSOM news release, they determined that 47.7% of all hospital-associated medical care between 1996 and 2010 was delivered by EDs.
Results Show EDs Critical to Healthcare Delivery
This a remarkable revelation. “I was stunned by the results,” David Marcozzi, MD, Associate Professor and Assistant Chief Medical Officer for Acute Care, UMSOM Department of Emergency Medicine, told Becker’s Hospital Review. Marcozzi led the study, which involved researchers from Thomas Jefferson University and other academic institutions.
“This research underscores the fact that emergency departments are critical to our nation’s healthcare delivery system,” he continued. “Patients seek care in emergency departments for many reasons. The data might suggest that emergency care provides the type of care that individuals actually want or need.”
As Becker’s Hospital Review explained, there were about 130-million visits to hospital EDs as compared to 101-million outpatient visits, and 39-million inpatient visits during 2010, the most recent year analyzed by UMSOM.
Quantifying the EDs Contribution to Healthcare
The researchers studied the role EDs play in caring for Americans, as compared to hospital outpatient and inpatient sectors. They were motivated, in part, by the apparent extra attention healthcare decision-makers pay to inpatient services and costs. As an emergency medicine and population health specialist, Marcozzi (who also works in the UM Medical Center Emergency Department) challenged that focal point.
In the first study to quantify the contribution of emergency department care to overall US healthcare, researchers at the University of Maryland School of Medicine (UMSOM) have found that nearly half of all US hospital-associated medical care is delivered by emergency departments. In this video, David Marcozzi, MD, MHS-CL, FACEP, talks about why this is happening and what the ramifications are for healthcare delivery in the US. Click on image above to view video. (Video and caption copyright: University of Maryland School of Medicine.)
The researchers cited National Center for Health Statistics data suggesting just 12% of ED encounters led to hospitalizations. This seems to counter claims of up to 50% of all healthcare being delivered in EDs. However, the researchers note that EDs also serve the uninsured and poor, many of whom are not admitted to the hospital.
“Traditional approaches to assessing the health of populations focus on the use of primary care and the delivery of care through patient-centered [medical] homes, managed care resources, and accountable care organizations. The use of EDs has not been given much consideration in these models,” the authors wrote in their paper.
ED Visits Jump Nearly 44% over 14 Years
Researchers analyzed ED patient, outpatient, and inpatient data from these sources:
- National Hospital Ambulatory Medical Care Survey
- National Hospital Discharge Survey
- Electronic data files (sources of patient demographics and medical information) from commercial organizations, state data systems, hospitals, and hospital associations
They discovered that 3.5-billion healthcare encounters occurred over the 14-year period studied (1996 to 2010), representing a 43.7% increase in ED visits during that time.
During that period, ED utilization resulted in:
- 1.6-billion ED visits or 47.7%
- 1.3-billion outpatient visits or 37.6%
- 5.2-million hospital admissions or 14.8%
The UMSOM study also found EDs were increasingly being used by African Americans in the south and west and by Medicaid beneficiaries, Fierce Healthcare reported.
“When considering the isolated ED case mix, Medicaid as a course of payment showed a major increase in its contribution, shifting from 19.4% to 27.5% of all emergency care,” the researchers noted.
What’s needed, according to the study authors, are solutions to address non-urgent conditions often seen in EDs. However, they acknowledge, that the topic has drawn controversy.
Insurers Respond to Trend by Dropping Coverage of ‘Unnecessary’ ED Treatments
Some insurance companies on the hook for increasing ED costs have devised a novel approach to the increased cost—stop paying for it.
A Dark Daily e-briefing recently covered one such “solution” involving letters sent to Anthem Blue Cross and Blue Shield (BCBS) of Georgia members informing them that ED services deemed “unnecessary” by BCBS would no longer be paid. (See Dark Daily, “Anthem Blue Cross Blue Shield of Georgia Drops Coverage for Non-Emergency ER Visits; Medical Laboratories Could See Drop in ER Clinical Lab Test Orders,” July 14, 2017.)
These new guidelines, which created quite a stir in Georgia before they went into effect July 1, 2017, are mirrored at BCBS affiliates in New York, Missouri, and Kentucky, noted sources in the Dark Daily report.
Non-avoidable Healthcare Events and ‘Connecting the Care’
In apparent response to this trend, a study published in the International Journal for Quality in Health Care, found that just 3.3% of ED visits are actually “avoidable.”
“Despite a relentless campaign by the insurance industry to mislead policymakers and the public into believing that many ER visits are avoidable, the facts say otherwise,” stated Becky Parker, MD, President of the American College of Emergency Physicians (ACEP), in a news release.
UMSOM’s Marcozzi says the aim should be to “connect the care” delivered in EDs with other care offered by the healthcare system.
“Restricting EDs to patients classified as having critical illness does not seem a feasible or humanitarian option, as many individuals would not be able to find care elsewhere. In addition, many people do not have the knowledge to determine which symptoms indicate an emergency,” the researchers note.
Clinical Laboratories Can Download the UMSOM Full Study for Future Reference
At this point, it’s not clear how increasing ED costs and decreasing insurance payments will impact medical laboratories and anatomic pathology groups. Nevertheless, the UMSOM study is a good resource. ED volume and test orders will likely increase as more people go to EDs for treatment.
As a special to Dark Daily readers, Sage Publications is granting full access to UMSOM’s study through March 31, 2018. After that date, only the abstract will be available to non-IJHS subscribers. Click here to reach the full study article or place this URL into your browser: http://journals.sagepub.com/stoken/default+domain/JG8RNXfhAf7fuhFRIUIV/full.
—Donna Marie Pocius
Related Information:
Trends in the Contribution of Emergency Departments to the Provision of Hospital-Associated Health Care in the USA
University of Maryland School of Medicine Study Finds That Nearly Half of U.S. Hospital-Associated Medical Care Comes from Emergency Rooms
Nearly 50% of US Medical Care Occurs in EDs
ERs Provide Nearly Half Medical Care in U.S., Study Finds
Avoid Emergency Department Visits: A Starting Point
Only 3.3% of ER Visits Are Avoidable
Anthem Blue Cross Blue Shield of Georgia Drops Coverage for Non-Emergency ER Visits; Medical Laboratories Could See Drop in ER Clinical Lab Test Orders
Jan 19, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
This may especially benefit cancer research and treatment thanks to MALDI’s ability to provide pathologists with a view of the whole-tissue micro-environment
Though it may be years before Matrix-Assisted Laser Desorption Ionization (MALDI) mass spectrometry finds use in clinical applications, recent developments show medical laboratories and anatomic pathologists how one type of technology is being rapidly adapted for use in diagnosing cancers.
Richard Drake, PhD, Director of the Medical University of South Carolina (MUSC) Proteomics Center, notes the importance of MALDI to cancer research. “In the clinic, there has to be something that will facilitate looking at all this data—tools that will let the pathologists look at it as well as the mass spec person,” Drake told GenomeWeb.
“It has been known for decades that glycosylation changes on the cell surface promotes cancer progression and the way the immune system sees a tumor or doesn’t see a tumor,” he explained. “That’s the advantage of MALDI imaging. You’re looking at the whole tissue micro-environment, and particularly for cancer it turns out to be important.”
Imaging Mass Spectrometry Applications for Anatomic Pathology
MALDI uses mass spectrometry imaging technology to enable high-molecular identification and an overall view of tissue. It differs from liquid chromatography-mass spectrometry (LC-MS), which is a chemical analysis technique.
An article by News-Medical describes in detail how MALDI technology works:
“MALDI imaging works through the utilization of a matrix, an acidic aromatic molecule that absorbs energy of the same wavelength produced by the irradiating laser. The matrix transfers the substance being examined to the gas state, thereby producing ionization in a three-step process:
1. “Thin sample sections on a metal slide are first covered with the matrix and the procedure for extracting molecules of interest from the tissue into the matrix begins. The matrix can be applied both manually and automatically.
2. “The laser irradiates the sample only in the matrix layer, meaning the underlying tissue remains intact.
3. “The released molecules are transferred to the gas state as the matrix absorbs the laser energy. Ions are formed due to the addition or removal of protons when in the gas state.
“The irons are required for further analysis via the mass spectrometer. The metal slide is placed into a MALDI mass spectrometer where the spatial distribution of the biological molecules is mapped. Within the mass spectrometer, the tissue specimen is raster scanned forming a mass spectrum for each spot measured. Image processing software is then required to import the data from the mass spectrometer to allow visualization of the image produced.”
The above schematic illustrates “the identification of bacteria and yeast by MALDI-TOF MS using the intact-cell method. Bacterial or fungal growth is isolated from plated culture media (or can be concentrated from broth culture by centrifugation in specific cases) and applied directly onto the MALDI test plate. Samples are then overlaid with matrix and dried. The plate is subsequently loaded into the MALDI-TOF MS instrument and analyzed by software associated with the respective system, allowing rapid identification of the organism.” (Caption and image copyright: Clinical Microbiology Reviews/American Society for Microbiology.)
MALDI in Clinical Laboratories
MALDI experts at MUSC worked with researchers at Bruker Corporation, a developer of scientific instruments and analytical diagnostic solutions for cell biology, preclinical imaging, clinical phenomics and proteomics research, clinical microbiology, and for molecular pathology research. Bruker is reportedly working with labs in Europe on MALDI-based assays for clinical use.
Developing MALDI applications for use in clinical laboratories and anatomic pathology groups could result in major improvements. Imaging mass spectrometry could:
- make more molecular information available;
- reduce pathology’s subjectivity and intra-observer nature;
- enable more accuracy and ability to duplicate current pathology assays; and,
- pave the way for new assays to be made.
“MALDI-IMS [imaging mass spectrometry] identifies the distributions of proteins, peptides, small molecules, lipids, and drugs and their metabolites in tissues, with high spatial resolution. This unique capacity to directly analyze tissue samples without the need for lengthy sample preparation reduces technical variability and renders MALDI-IMS ideal for the identification of potential diagnostic and prognostic biomarkers and disease gradation,” noted authors of a MALDI study published in the July 2017 edition of Biochimica et Biophysica Acta Proteins and Proteomics.
“You can take a slide of tissue and essentially do metabolomics on it so that you can look at the intricate nature of what metabolism is happening within a tissue,” James MacRae, PhD, Head of Metabolomics at the Francis Crick Institute in London, told Technology Networks, which described development of new mass spectrometry imaging technologies as “potentially game-changing.”
Mass Spectrometry in Clinical Laboratories
This is just the latest in a string of scientific developments involving mass spectrometry over the past decade that are potential boons to clinical laboratories. In “Is Mass Spectrometry Ready to Challenge ELISA for Medical Laboratory Testing Applications?” Dark Daily reported on the development of a new technique from the Department of Energy’s Pacific Northwest National Laboratory that uses mass spectrometry to identify protein biomarkers associated with cancer and other diseases. Researchers dubbed the technique PRISM, which stands for Proteomics Research Information System and Management.
And in “Swiss Researchers Use New Mass Spectrometry Technique to Obtain Protein Data, Create Strategy That Could Lead to Clinical Laboratory Advances in Personalized Medicine,” Dark Daily reported on researchers at the Swiss Federal Institute of Technology in Lausanne and ETH Zurich who developed a new way to use mass spectrometry to explain why patients respond differently to specific therapies. The method potentially could become a useful tool for clinical laboratories that want to support the practice of precision medicine.
As mass spectrometry’s role in clinical laboratories continues to expand, MALDI technology development and research could eventually lead to tools and applications that enhance how anatomic pathologist view tissue specimens in the medical laboratory. Though the research is ongoing, the technology seems particularly suited to cancer research and treatment.
—Donna Marie Pocius
Related Information:
Technical Advances Position MALDI Imaging as Plausible Tool for Clinical Pathology
Bruker Introduces Novel Mass Spectrometry Solutions for MALDI Imaging, Metabolomics, Proteoform Profiling, and Toxicology at ASMS 2017
The Proteomics of Prostate Cancer Exosomes
MALDI Imaging
Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry: A Fundamental Shift in the Routine Practice of Clinical Microbiology
Metabolomics and Health – On the Cusp of a Revolution
Is Mass Spectrometry Ready to Challenge ELISA for Medical Laboratory Testing Applications?
Swiss Researchers Use New Mass Spectrometry Technique to Obtain Protein Data, Create Strategy That Could Lead to Clinical Laboratory Advances in Personalized Medicine
Precision Medicine Summit Feb. 21, 2018
Jan 17, 2018 | Coding, Billing, and Collections, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Management & Operations
Moving to market are the newest generation of LIMS products designed to serve clinical laboratories while supporting quality reporting initiatives and new sources of revenue
It was Bob Dylan who made a big hit out of the song, “The Times, They Are A-Changin’.” The same could be said for the next generation of software products designed for use by medical laboratories.
To be fully successful, these next-generation laboratory information management systems (LIMS) must be radically different than the generations that came before. For example, medical laboratories are frustrated with the many limitations of older LIS products that still incorporate software technologies that date back to the 1980s and 1990s, such as MUMPS, which stands for Massachusetts General Hospital Utility Multi-Programming System.
But the newest LIMS products must do more than simply incorporate the latest technologies in software and cloud-based services. They must support all the ways that clinical laboratories and anatomic pathology groups generate increased revenue. More specifically, all medical laboratories will be generating vast quantities of molecular and genetic data. Therefore, an effective LIMS must be capable of capturing that data while also enabling the lab to perform certain healthcare big data analyses in support of the referring physicians and parent hospitals.
There also will be the need for medical laboratories to use their LIMS capabilities to support the data reporting requirements of Medicare and private health insurers. Payers increasingly want providers to report their quality monitoring, patient outcomes, and certain cost-of-care parameters. All these are functions that older LIS (laboratory information systems) products were not developed to provide.
Anatomic pathology group stakeholders and clinical laboratory managers understand the vital importance of their LIMS. Laboratory and healthcare workflows depend on the system’s:
- efficiency;
- scalability that supports the growth of the lab and medical practice; and,
- flexibility to interface with modern, point-of-care telehealth technologies in ways that enable labs and practices to engage in today’s precision medicine healthcare initiatives.
The more immediate need is for a LIMS to be capable of supporting Medicare’s Quality Payment Programs (QPPs), primarily the MACRA Merit-based Incentive Payments System (MIPS). Most physicians, including pathologists, will participate in MIPS. The first Medicare incentives or penalties will be paid next year, based on 2018 metrics and performance.
Given all these changing demands of advanced software technologies and the need for medical laboratories to participate in various value-based revenue programs, how might a LIMS empower labs to ensure success and increased revenue?
Quality Payment Programs and Merit-based Incentives
As part of the shift toward value-based care, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) works to drive down costs and increase quality within both care and laboratory environments. MACRA establishes a data-driven payment system to reimburse service providers based on the outcome of services and care episodes, instead of the volume of services delivered or billed.
Combined with reduced payments, MACRA’s incentives and penalties, and Medicare’s QPP/MIPS payment programs, pressure has been increased on healthcare providers and medical laboratories alike. Thus, technology that gives labs a competitive edge is essential for thriving in an ever-evolving and increasingly competitive marketplace.
Meeting MACRA Goals with a Laboratory Information Management System
While electronic health record (EHR) systems have helped to consolidate patient protected health information (PHI), they do little to address the real-time creation of laboratory data and the accessibility of the massive volume of lab-related data stored in the average patient’s medical files.
A LIMS, however, helps to consolidate all this data in an easily accessible and powerful system. Some LIMS even combine with telehealth technologies to make data actionable and available at the point-of-care.
In this type of LIMS, laboratories, physicians, and other care providers all access the same dataset to ensure information is relayed quickly and efficiently. Interaction takes place using cloud-based interfaces, such as mobile apps or web portals. This ensures access to patient data and laboratory test results in a variety of locations without dependence on proprietary communications systems or hardware.
From bustling ERs and surgical wards to phlebotomists visiting long-term care facilities and mobile clinics, collecting and retrieving data becomes streamlined and accessible virtually anywhere.
The chart above illustrates how a LIMS offers increased potential to automate processes and scale operations while keeping physicians, patients, and other critical parties up to date. This increase in efficiency and access to data empowers providers to reach improved patient outcomes and reduce hospital readmission rates, increasing revenue for both clinicians and clinical laboratories. (Graphic copyright: NetLIMS.)
When implemented properly, a LIMS also helps laboratories and healthcare facilities meet the terms of MIPS. This reduces Medicare penalties and ensures payment adjustments, which improve revenue streams even further.
Understanding LIMS and Cloud-Based Lab Systems
To help outline and explain the benefits of a LIMS for laboratories and healthcare facilities, The Dark Report, in conjunction with NetLIMS, a global provider of laboratory information management systems to hundreds of hospitals and commercial laboratories worldwide, has produced a free white paper titled, “The Path to More Revenue: Cloud-Based LIMS, Mobile Apps, and Point-of-Care Telehealth.”
- This white paper addresses critical concerns, including:
- Overviews of new technologies;
- The impact of value-based programs on the lab market;
- The importance of MACRA and MIPS adherence;
- How technology, such as a LIMS, can help labs achieve improved efficiency; and,
- Tips on choosing a LIMS vendor to maximize ROI.
To download your free copy of the whitepaper click on this link: Or, copy this URL into your browser: https://www.darkdaily.com/whitepaper/the-path-to-more-revenue-cloud-based-lims-mobile-apps-and-point-of-care-telehealth .
Thanks to advances in LIMS design and development, remote patient digital therapeutics, and cloud-based technology, healthcare providers now have unprecedented opportunities to better manage the health of patients with chronic conditions. In addition, it can help you achieve better efficiency, economics, and compliance with MACRA.
This free white paper is your first step toward significantly reducing hospital readmission rates, bridging the gap between labs, physicians, and other healthcare providers they serve, and positively affecting patient outcomes, improving quality measures, and maximizing reimbursements for all services you provide.
—Jon Stone
Related Information:
The Path to More Revenue: Cloud-Based LIMS, Mobile Apps, and Point-of-Care Telehealth
How Close Is the End of Private Practice Pathology as We’ve Known It?
Attention Anatomic Pathologists: Do You Know Medicare Is Prepared to Change How You Are Paid, Beginning on January 1, 2017?
Innovator Hospitals Bring ICUs into the Info Age, Using New Design Approaches that involve Medical Laboratory Tests
Jan 15, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Lab-on-skin is the latest concept to join the lab-on-a-chip, lab-in-a-needle, and lab-on-paper field, as researchers continue to seek ways to miniaturize medical laboratory tests
Move over, lab-on-a-chip and lab-on-paper. There’s a new diagnostic technology in research labs that is gaining credibility. It is called lab-on-skin technology and some scientists are quite excited about how it might be used for a variety of clinical purposes.
A recent story published in ACS Nano titled, “Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring,” reviews the latest advancements in lab-on-skin technology. It provides an overview of different research initiatives incorporating lab-on-skin technologies.
From telehealth to precision medicine to point-of-care mobile devices, anatomic pathologist and clinical laboratories are about to be challenged with new diagnostic technologies. These technologies are intended to streamline the workflow between physicians and medical laboratories while improving access to patient data and medical laboratory test results.
Of all the mobile devices designed to support medical care, no technology may have more potential to change the pathology profession than nanotechnology-based diagnostic devices. Whether lab-on-a-chip, lab-in-a-needle, or lab-on-paper, these miniature laboratories are so small dozens can be carried in a pocket.
Most importantly, for certain diagnostic tests, some of these devices being developed hope to deliver full-size-lab quality results accurately and inexpensively, even in rural regions and areas with little or no resources, such as electricity or water. (See Dark Daily, “Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?” September 9, 2016.)
Now, researchers have demonstrated that even biomarkers within human skin can be tested by medical wearable devices. “Lab-on-skin” has entered the pathology vernacular.
Lab-on-Skin Constantly Measures Physiological Data
According to ACS Nano, lab-on-skin devices are small electronic patches worn directly on the skin that noninvasively measure a variety of physiological data. These flexible gadgets can interpret information including:
- body temperature;
- blood oxygenation;
- hydration;
- blood pressure;
- glucose;
- potassium;
- sodium; and,
- lactate and pH levels in individuals.
The devices may also be used for wound care, prosthetics and rehabilitation, as well as for optogenetics and human-machine interfaces (HMI).
The image above from the ACS Nano article demonstrates various lab-on-skin devices, including: an NFC tattoo with a bare die chip mounted on an acrylic adhesive film; a soft radio sensor with commercial chips encapsulated in a fluid/ecoflex package; and, a sweat sensor on silicone foam. Each of these devices could be capable of delivering actionable diagnostic data to anatomic pathologists and clinical laboratories. (Image copyright: ACS Nano.)
Lab-on-skin technology can be utilized to read electrophysiological signals typically measured by electrodes placed on various parts of the body, such as:
The direct connection between the patches and the skin allows for continuous and precise data collection without the threat of drying out that comes with traditional electrodes.
Nanotechnology Driving Clinical Laboratory Diagnostic Applications
Because it is the largest organ in the body, skin provides a perfect pathway to convey biological information originating from various parts of the body, such as inner organs, muscles, blood vessels, and the dermis and epidermis.
The ACS Nano article discusses advancements in the designs and materials used for lab-on-skin patches. In addition to the term “lab-on-skin,” these devices may also be referred to as electronic skin, epidermal electronics, and electronic tattoos. They have untapped potential in a variety of clinical applications, including:
For example, researchers at the University of Illinois at Urbana-Champaign have created an epidermal nanotechnology device that utilizes sensors and wireless interfaces to measure ultraviolet (UV) exposure, a risk factor for skin cancers.
“Our goal with this research is to establish a set of foundational materials and device designs for systems that can improve health outcomes by providing information on UV exposure,” John A. Rogers, PhD, and Professor of Materials Science and Engineering and Professor of Chemistry told Nanowerk Spotlight.
Nanotechnology employs extremely small particles performed at the nanoscale (about 1 to 100 nanometers). This field is emerging as a vital element behind cutting-edge innovations in medicine and healthcare.
“We developed new chemistries that yield color changes that quantitatively relate to total exposure dose, separately in both the UV-A and UV-B regions of the solar spectrum,” explained Rogers. “Our formulations have the additional advantage that they provide soft, low modulus mechanics to enhance comfort and biocompatibility with the skin surface.”
Mini-Laboratory Devices Could Push Pathology Data to Clinical Laboratories
The combination of using lab-on-skin devices with nanotechnology can provide researchers and medical professionals a multifunctional and valuable tool for health monitoring and the diagnosis of diseases. However, more research and clinical studies are needed to establish the validity of using lab-on-skin devices in healthcare applications.
Nevertheless, clinical laboratories and pathology groups will be handling more data in the future, generated by these miniature laboratory devices. Their usefulness, especially in challenging healthcare environments, is only beginning to be fully discovered.
—JP Schlingman
Related Information:
A Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring (downloadable PDF)
Lab-on-Skin: A Review of Flexible and Stretchable Electronics for Wearable Health Monitoring (original ACS Nano article)
Lab-on-Skin: Nanotechnology Electronics for Wearable Health Monitoring
Stick-on Epidermal Electronics Tattoo to Measure UV Exposure
Nanotechnology in Healthcare (Part 1: Fitness Monitoring, Diagnostics and Prevention)
Nanotechnology in Healthcare (Part 2: Nanomedicine Therapy)
Breathable, Wearable Electronics on Skin for Long-term Health Monitoring
Nano-chip Promises to Heal Organs at a Touch
IBM and Mount Sinai Researchers Develop Innovative Medical Lab-on-a-Chip Solution
Lab-on-a-Chip Diagnostics: When Will Clinical Laboratories See the Revolution?
Researchers at University of Rhode Island Unveil Lab-on-Paper Test Capable of Multireagent Diagnostics: Could Enable ‘Diagnostics Without the Lab’ Say Developers
Sleek ‘Lab in a Needle’ Is an All-in-One Device That Detects Liver Toxicity in Minutes during a Study, Showing Potential to Supplant Some Medical Laboratory Tests
