Feb 28, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations, News From Dark Daily
As healthcare reform continues to impact revenues for medical labs and anatomic pathology groups in an effort to reduce healthcare spending, researchers reinforce claims that prices are to blame, not quantity or quality of care
All facets of the US healthcare system—be it massive health systems, medical clinics, independent anatomic pathology groups, or medical laboratories—are experiencing pressure as healthcare reform attempts to manage ever-growing healthcare spending.
Current healthcare trends in the United States focus on determining medical necessity, adopting personalized medicine, and on determining the value various aspects of care. What these trends have in common is a goal of lowering the cost of care while contributing to improved patient care. However, research dating back as far as 2003 suggests overall prices play a significant role in US healthcare spending, particularly when the cost of care in the US is compared to the cost of care in other developed countries.
US Spends More on Healthcare than Any Other Country
A study published last year was the subject of a recent story in the New York Times about why healthcare costs in the United States are so much higher than in other developed nations. The NYT story referenced multiple studies on the subject that all made a similar conclusion: utilization of healthcare in the US is at or below the median compared with other developed nations, and it is higher prices for these services that causes healthcare in the US to be so expensive.
Health Affairs published one such study in 2003, titled, “It’s the Prices, Stupid: Why the United States is So Different from Other Countries.” Written by Gerard F. Anderson, PhD; Uwe E. Reinhardt, PhD; Peter S. Hussey, PhD; and Varduhi Petrosyan, PhD, the paper compared data from the Organization for Economic Cooperation and Development (OECD) for 30 member countries in 2000.
“The data show that the United States spends more on healthcare than any other country. However, on most measures of health services use, the United States is below the OECD median,” researchers state. “These facts suggest that the difference in spending is caused mostly by higher prices for healthcare goods and services in the United States.”
In a New York Times article, Austin Frakt, PhD (above left), Health Economist with the federal Department of Veterans Affairs, and Aaron E. Carroll, MD (above right), pediatrician and Professor of Pediatrics at Indiana University School of Medicine, collated the various research into healthcare spending conducted in the past decade and a half. (Photo copyrights: JAMA/The Accidental Economist.)
“What was true in 2003 remains so today,” Ashish Jha, MPH, a physician with the Harvard T.H. Chan School of Public Health and the director of the Harvard Global Health Institute, told The New York Times (NYT). “The US just isn’t that different from other developed countries in how much healthcare we use. It is very different in how much we pay for it.”
New Data Shines the Spotlight on Old Concerns
Using data spanning from 1996 to 2013, researchers published similar findings in a 2017 JAMA original investigation. “Healthcare spending increased by $933.5 billion from 1996 to 2013,” stated study authors Joseph L. Dieleman, PhD, Assistant Professor at Institute for Health Metrics and Evaluation; Ellen Squires, MPH, Policy Analyst at Kaiser Family Foundation; and Anthony L. Bui, MPH, MD Candidate at David Geffen School of Medicine, UCLA Health. “Service price and intensity alone accounted for more than 50% of the spending increase, although the association of the five factors with spending varied by type of care and health condition.”
The JAMA study authors noted they could not separate price and care intensity in their data. However, as pointed out by NYT, four other studies published by The National Bureau of Economic Research, the OECD, JAMA, and the Annals of Internal Medicine between 2010 and 2017 also link the cost of care directly with healthcare spending in the US.
“The JAMA study found that, together, [care intensity and pricing] accounted for 63% of the increase in spending from 1996 to 2013,” noted The New York Times, “In other words, most of the explanation for American health spending growth—and why it
has pulled away from health spending in other countries—is that more is done for patients during hospital stays and doctor visits, they’re charged more per service, or both.”
For example, the OECD pilot study from 2010 states, “One of the key findings of the pilot study is that the price level of hospital services in the United States is more than 60% above that of the average price level of 12 countries included in the study.”
The More Things Change the More They Stay the Same
As a cornerstone of economics, transparency in both pricing and quality serves to empower buyers—or in this case patients—to choose products and services based on their overall value. This, in turn, encourages competition and helps to keep prices in check.
However, the US healthcare system offers little transparency—either for patient outcomes or for the prices to be charged—with many patients not having any clue what a service will cost until the bill for their recent hospital stay, lab tests, wellness visit, or ER visit arrives. This has led to increased pressure from employers and patient advocates for hospitals, clinical laboratories, and other service providers to make this information available to the public.
Yet, the opposite scenario is the current reality. Lobbyists and groups representing hospitals, insurers, pharmaceuticals, and other facets of the healthcare system continue to promote legislation at the federal and state levels to keep this information private and away from both the public and their competitors.
The NYT highlights the balance surrounding the issue citing claims of increased innovation with higher prices. However, this only works if the market can support said prices. “Though it’s reasonable to push back on high healthcare prices,” NYT’s noted, “there may be a limit to how far we should.”
—Jon Stone
Related Information:
Why the US Spends So Much More than Other Nations on Health Care
Decomposing Medical Care Expenditure Growth
Comparing Price Levels of Hospital Services Across Countries
The Anatomy of Healthcare in the United States
Price and Utilization: Why We Must Target Both to Curb Health Care Costs
Factors Associated with Increases in US Health Care Spending, 1996–2013
It’s the Prices, Stupid: Why the United States is So Different from Other Countries
US Health Care from a Global Perspective
Feb 23, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Researchers successfully isolated both plant and human RNA and DNA in the field, demonstrating the potential for their new dipstick technology to identify deadly bacteria, pathogens, and diseases in water, food, and even humans
Australian researchers at the University of Queensland (UQ) have developed an intriguing “dipstick” technology that might make it possible to use simple equipment to sequence DNA and RNA in the field. Among the potential applications that will interest clinical laboratory professionals is the ability for this technology to identify pathogens, both in humans and the environment.
Medical laboratories and anatomic pathologists are aware that gene sequencing (AKA, Nucleic Acid Sequencing) is the coming revolution in diagnostics. But the process is still costly and anchored to immovable technology that requires controlled environments and reliable resources. This promising new technology could make it simpler, cheaper, and faster to extract human DNA and RNA in settings outside a sophisticated core medical laboratory.
The UQ researchers developed technology that could affect how and where diagnostic tests for a whole range of pathogens are performed. For example, tests for bacteria such as E. coli in water supplies, pathogens in food, and diseases in humans currently are conducted in environmental and clinical laboratories. This new technology may allow such diagnostics to be done in extremely remote environments.
Isolating DNA/RNA in the Field
Jimmy Botella, PhD, Professor of Plant Biotechnology, and Michael Mason, PhD, Senior Post-doctoral researcher, both at the University of Queensland, led a team of researchers who published their findings in the journal PLOS Biology. The team developed a process they called “dipstick technology,” which allows DNA and RNA to be isolated quickly and without the use of specialized equipment.
They began by using the technology on particular plants, but soon found it could be used in many other situations.
“We found it had much broader implications as it could be used to purify DNA or RNA from human blood, viruses, fungi, and bacterial pathogens from infected plants or animals,” Botella noted in a press release.
The researchers’ objective was to investigate whether or not several different materials could be used to extract nucleic acids. “The first step in any application aiming to amplify DNA or RNA is the extraction of nucleic acids from a complex biological sample; a task traditionally requiring specialized equipment, trained technicians, and multiple liquid handling steps,” they wrote in the published study.
Holding the dipstick technology (from left) Dr. Michael Mason, Professor Jimmy Botella, and Yiping Zhou, all researchers at the University of Queensland in Brisbane, Australia. (Caption and photo copyright: University of Queensland.)
Their aim was to find a simpler process that required far less personnel and equipment. They found that cellulose-based filter paper could be used to bind nucleic acids. The filter paper, which was the control early in their investigation, even retained the nucleic acids through a purification process that removed contaminants. “We then adapted the cellulose filter to create a dipstick that can be used to purify nucleic acids from a wide range of plant, animal, and microbe samples in less than 30 seconds without the need for specialized equipment,” the researchers reported.
The team conducted its first tests on the plant species A. thaliana, a flowering plant found in Africa and Eurasia. However, wanting their dipstick technology to be useful in the field, they expanded their experiments to include various species of wheat, rice, soybean, tomato, and other plants. Citrus plants, known to be challenging, also were successfully tested.
The researchers then tested if their new technology would be useful for applications in humans, which is more complicated. HIV and hepatitis can be diagnosed using commercial kits, but those kits are not useful in many settings because the samples often require sophisticated manipulation. The researchers’ method—using cellulose paper and a one-minute wash—succeeded in amplification of the nucleic acid.
Performing Diagnostics in Hospitals, on Farms, and Even in the Jungle!
The University of Queensland’s commercialization company, UniQuest, has filed a patent application for the new technology. They are currently seeking partners to commercialize and sell the dipstick technology worldwide.
“Our dipsticks, combined with other technologies developed by our group, mean the entire diagnostic process from sample collection to final result could be easily performed in a hospital, farm, hotel room, or even a remote area such as a tropical jungle,” Botella noted in the press release.
The team conducted much of their field research on remote plantations in Papua New Guinea. They conducted tests on trees, livestock, human diseases, and to detect pathogens in food and water. “The dipstick technology makes diagnostics accessible to everyone,” Botella told Technology Networks.
Dipstick Diagnostics Not New to Point-of-Care Testing
As Modern Healthcare Executive noted, dipstick technology for various diagnostic purposes is not new, even though this particular application is, potentially, revolutionary. There are dipstick tests for everything from pregnancy to cholera. Also referred to as point-of-care testing (POCT), research and development of this technology has steadily grown, and as the UQ study shows, will likely continue.
In a paper published in Clinical Biochemistry Reviews, authors Andrew St. John, PhD, of ARC Consulting, and Christopher Price, MD, of the University of Oxford, noted, “Healthcare is changing, partly as a result of economic pressures, and also because of the general recognition that care needs to be less fragmented and more patient-centered.”
While there are certainly advantages to quick diagnostic tests that can be conducted in the field, there are some challenges, as well. Julie L. V. Shaw, PhD, Assistant Professor, Department of Pathology and Laboratory Medicine at The University of Ottawa, argues that “there are many challenges associated with POCT, mainly related to quality assurance,” in a paper she published in the journal Practical Laboratory Testing.
Technology will continue to develop and drive innovation and change in how diagnostics are performed and thus in how clinical laboratories operate. Various initiatives driving the industry toward personalized medicine and value-based care are sure to play a role, alongside new technology and other advancements.
With all of those changes, one thing remains critically important and that is the value of human understanding and innovation.
—Jillia Schlingman
Related Information:
Nucleic Acid Purification from Plants, Animals and Microbes in Under 30 Seconds
UQ Dipstick Technology Could Revolutionize Disease Diagnosis
Dipstick Technology Enables Rapid Diagnosis Anywhere
Existing and Emerging Technologies for Point-of-Care Testing
Practical Challenges Related to Point of Care Testing
The March of Technology Through the Clinical Laboratory and Beyond
Feb 21, 2018 | Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
It has been regularly demonstrated in recent decades that human breath contains elements that could be incorporated into clinical laboratory tests, so the decision to use this “breath biopsy” test in a therapeutic drug trial will be closely watched
When a major pharma company pays attention to a breath test, implications for clinical laboratories are often forthcoming. Such may be the case with GlaxoSmithKline (GSK). The global healthcare company has selected Owlstone Medical’s Breath Biopsy technology for use in its Phase II clinical trial of danirixin (DNX), a respiratory drug under development by GSK for treatment of chronic obstructive pulmonary disease (COPD), an Owlstone Medical news release announced.
Anatomic pathologists and medical laboratory leaders will be intrigued by GSK’s integration of breath-based specimens in a clinical trial of a respiratory drug. The partners in the trial aim to analyze breath samples to better understand the drug’s treatment effects and to discover personalized medicine (AKA, precision medicine) opportunities.
GSK (NYSE:GSK), headquartered in the UK but with a large presence in the US, researches and develops pharmaceutical medicines, vaccines, and other consumer health products.
Owlstone Medical, a diagnostic company, is developing a breathalyzer for disease and says it is on a mission to save 100,000 lives and $1.5 billion in healthcare costs. Dark Daily previously reported on Owlstone Medical’s Breath Biopsy platform. The Cambridge, England-based company has raised significant funding ($23.5 million) and already garnered credible cancer trial collaborators including the UK’s National Health Service (NHS).
Now, Owlstone Medical has brought its breath analysis technology to bear on chronic disease outside of cancer diagnostics development. A pharmaporum article called Owlstone’s Medical’s work with GSK an “additional boost of confidence” in the company’s technology, as well as a means for revenue.
Billy Boyle, co-founder and Chief Executive Officer, Owlstone Medical (above), shown with the company’s ReCIVA Breath Sampler device. This will be used by GSK in its Phase II respiratory disease clinical trial of danirixin to “capture VOC biomarkers in breath samples.” (Photo copyright: Business Weekly UK.)
GSK Studying Future Treatments for Respiratory Diseases
COPD affects about 700 million people worldwide, an increase of about 65% since 1990, GSK pointed out. In September 2017, GSK presented respiratory disease data and its pipeline medications at the European Respiratory Society in Milan, Italy. Included was information on danirixin (an oral CXCR2 antagonist), which is part of the company’s focus on COPD disease modification, according to a GSK news release.
“Each of our studies sets the bar for our future research and innovation,” noted Neil Barnes, MA Cantab, FRCP, FCCP(Hon), Vice President, Global Franchise Medical Head, GSK Respiratory, in the GSK press release.
Clinical Trial Aimed at Identifying the ‘Right’ Patients
With Owlstone Medical’s breathalyzer, GSK plans to explore how volatile organic compounds (VOCs) can help identify patients who will benefit most from the company’s medications, as well as evaluate Danirixin’s effects. A critical element of personalized medicine.
“It’s part of our efforts to identify the right patient for the right treatment,” said Ruth Tal-Singer, PhD, GSK’s Vice President of Medicine Development Leader and Senior Fellow, Respiratory Research and Development, in the Owlstone Medical news release.
VOCs in breath will be captured in a non-invasive way from patients who wear Owlstone Medical’s ReCIVA Breath Sampler, which, according to Owlstone Medical, has CE-mark clearance, a certification noting conformity with European health and safety standards. The VOCs breath samples will then be sent to Owlstone Medical’s lab for high-sensitivity analysis.
“Non-invasive Breath Biopsy can establish a role in precision medicine applications such as patient stratification and monitoring treatment response,” said Billy Boyle, Owlstone Medical’s co-Founder and Chief Executive Officer.
VOC Biomarkers in Respiratory Disease
VOC profiles can be characteristic of COPD as well as other respiratory diseases including asthma, tuberculosis, and cystic fibrosis, reported Science/Business.
According to Owlstone Medical’s Website, VOCs are gaseous molecules produced by the human body’s metabolism that are suitable for Breath Biopsy. Their research suggests that exhaled breath reflects molecular processes responsible for chronic inflammation. Thus, VOCs captured through Breath Biopsy offer insight into respiratory disease biomarkers.
Breath also includes VOCs that originate from circulation, which can provide information on a patient’s response to medications.
How the Breath Biopsy Platform Works
Owlstone Medical’s platform relies on its patented Field Asymmetric Ion Mobility Spectrometry (FAIMS) technology, which “has the ability to rapidly monitor a broad range of VOC biomarkers from breath, urine and other bodily fluids with high sensitivity and selectivity,” according to the company’s website. During the process:
- Gases are exchanged between circulating blood and inhaled fresh air in the lungs;
- VOC biomarkers pass from the circulation system into the lungs along with oxygen, carbon dioxide, and other gases;
- Exhaled breath contains exiting biomarkers.
It takes about a minute for blood to flow around the body. So, a breath sample during that time makes possible collection and analysis of VOC biomarkers from any part of the body touched by the circulatory system.
The medical analysis is enabled by software in the Owlstone Medical lab, Boyle told the Cambridge Independent.
“There’s an analogy with blood prints—you get the blood and can look for different diseases, and we’ve developed core hardware and technology to analyze the breath sample,” he said.
Another Breath Sample Device
The ReCIVA Breath Sampler is not the only breathalyzer focused on multiple diseases. Dark Daily reported on research conducted by Technion, Israel’s Institute of Technology, into a breath analyzer that can detect up to 17 cancers, and inflammatory and neurological diseases.
But Owlstone Medical stands out due, in part, to its noteworthy partners: the UK’s National Health Service, as well as the:
And now the company can add collaboration with GSK to its progress. Though some question the reliability of breath tests as biomarkers in the areas of sensitivity and specificity required for cancer diagnosis, Owlstone Medical appears to have the wherewithal to handle those hurdles. It is a diagnostics company that many pathologists and medical laboratory professionals may find worth watching.
—Donna Marie Pocius
Related Information:
Owlstone Medical’s Breath Biopsy Platform Integrated into GSK’s Phase II Respiratory Disease Clinical Trial
GSK Utilizes Owlstone Disease Breathalyser for Key Clinical Trials
GSK Presents Respiratory Data from Pipeline to Clinical Practice at ERS
GSK Boosts Medtech First Owlstone with Use of Breath Biopsy in Respiratory Trial
Glaxo to Stratify COPD Trial Using Breath Biopsy Device
Billy Boyle of Owlstone Medical on the Inspiration Behind His Mission to Save 100,000 From Dying of Cancer
Owlstone Medical and UK’s NHS Study Whether Breath Contains Useful Biomarkers
Breath Based Biomarker Detection: Informing Drug Development and Future Treatment Regimes
Clinical Laboratories Could Soon Diagnose 17 Diseases with a Single Breath Analyzer Test from Israel’s Institute of Technology
Feb 16, 2018 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Precision medicine programs can benefit from wearable usage data; however, little information has been collected on personalities and behaviors of the device users
Wearables medical devices have the potential to monitor some of the same biomarkers used in medical laboratory tests today. In addition, these mobile technologies can make it possible for clinical laboratories to monitor patients in real time, as well as allow labs to incorporate such into a patient’s historical record of lab test results.
The trend toward personalized medicine (aka, Precision Medicine) is increasing, with many payment programs based on it. Thus, monitoring and correcting activities that cause chronic disease, or work against treatments, is becoming standard procedure for forward-thinking, technically proficient doctors and hospitals. But are patients onboard with all of it?
Activity Trackers for Monitoring Patient Behavior
With the popularity of activity trackers on the rise, researchers are examining their usage patterns to determine how the devices are being utilized, their target market, and ways to encourage sustained use of the gadgets.
A recent article published in Annals of Internal Medicine provided insight regarding who is using this type of wearable device, how activity trackers are being employed, and the length of time consumers will maintain their usage.
The research was spearheaded by Mitesh Patel, MD, Assistant Professor of Medicine and Health Care Management, Perelman School of Medicine and the Wharton School, University of Pennsylvania. He believes this is the largest study of its kind to evaluate the usage of wearable fitness trackers.
“Many people are excited by the potential of using activity trackers to monitor healthy behaviors, but there is very little evidence on who is using them and whether or not use is sustained over time,” Patel stated in a Penn Medicine news release. “We found that, though use grew over time, it really varied depending on individual characteristics like age and income. We also found that once someone started using an activity tracker, sustained use at six months was high at 80%.”
Patel is also Director of the Penn Medicine Nudge Unit, a behavioral design team that is studying the impact that nudges or small interventions may have on healthcare. The team is examining ways in which nudges can influence choices, and also direct medical professionals and patients toward optimal decisions to improve healthcare delivery and results. (Photo copyright: University of Pennsylvania.)
Gaming the Study Improves Usage of Test Devices
To perform the study, 4.4 million members of a national wellness program were invited to take part in data collection. Approximately 55,000 of those individuals actually participated in the study, which involved downloading an app to record pertinent information. Researchers tracked and interpreted the data during a two-year period in 2014 and 2015.
The information analyzed included:
- When participants initially activated their tracker;
- How often the device was utilized;
- The average number of steps taken per day; and,
- Sociodemographic characteristics.
The results of the study were not entirely unexpected, but there were surprises:
- 80% of the people who initially activated the devices were still using them after six months;
- Only 0.2% of the invited individuals used the devices in the first year;
- However, that number increased to 1.2% during the second year.
The usage of wearable activity trackers was nearly double among younger people than it was for older individuals. In addition, people from households with an annual income of less than $50,000 used the gadgets at lower rates than those at higher income levels.
A mere 0.1% of the potential participants were over 65-years old. However, 90% of individuals in this age group were still using the devices six months after initial activation.
The authors of the study stated that adding game elements, such as points, levels, badges and financial incentives may have played a role in the sustained use of the activity trackers.
“Gamification and financial incentives are commonly used within wellness programs, but their impact has not been well studied,” Patel stated in the news release. “Our findings provide initial evidence suggesting that these types of engagement strategies may show promise for keeping sustained use high. However, more studies are needed to determine the best way to combine these types of engagement strategies with activity trackers to improve health outcomes.”
Most Commonly Used Mobile Activity Tracking Devices
There were 60 different types of wearable activity trackers that could be used by participants for the study. Seventy-six percent of those participants elected to use the FitBit activity tracker. This mobile healthcare device is worn on the wrist like a watch. It monitors activity, exercise, food, weight, and sleep to provide consumers with real-time data about their activities.
The data collected by the device is sent automatically and wirelessly to the user’s phone or computer. Individuals then can use the FitBit dashboard to view their progress through online charts and graphs. The dashboard also offers progress notifications to the consumer and gives achievement badges when established goals have been reached.
The second most common activity trackers used were Apple devices, such as Apple Watches, which were chosen by 9% of the participants.
Biometric data on patients’ behavior and activities that is collected and transmitted from mobile devices has swiftly become critical data doctors use in precision medicine diagnoses and treatments. Clinical laboratories will likely be including biomarker data taken by these devices in their testing and procedures in the future. The only question is how quickly the data generated by such devices becomes acceptable to add to a patient’s permanent health record.
—JP Schlingman
Related Information:
New Wellness Study Shows Just How Sticky Wearables Can Be, Even Among Seniors
Penn Study Shows 80% of Activity Tracker Users Stick with the Devices for at Least Six Months
Game Time: To Increase Exercise, Study Shows Gaming Strategies and a Buddy Are Key
When Push Comes to Nudge
Improvements to Fitness Wearables Help Stream Data from Consumers’ Homes to EHRs and Clinical Pathology Laboratories
Apple May Be Developing Mobile Device Technology to Monitor User’s Health and Transmit Data in Real Time
Feb 14, 2018 | Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Tight provider networks have some seniors dropping private plans after losing access to ‘preferred doctors and hospitals’ and experiencing issues with ‘access to care’
Medicare Advantage Plans continue to rise in popularity. That trend has implications for clinical laboratories and anatomic pathology groups because private insurers running Medicare Advantage plans tend to have narrow or exclusive lab networks.
Thus, as Medicare patients shift from Medicare Part B (which pays any provider a fee-for-service reimbursement) to a Medicare Advantage plan (with a narrow network), labs in that community lose access to that patient.
Now a recent government study of the Medicare Advantage program has interesting findings. For seniors in poor health, the private healthcare plans can prove costly if they lose access to specialized healthcare and the freedom to go to any doctor or hospital.
High Turnover Could Mean Poor Quality Plans
A 2017 report by the Government Accountability Office (GAO) found that beneficiaries in poor health are more likely to disenroll from Medicare Advantage Plans—a sign that the quality of plans with higher than normal turnover may be poor. The agency reviewed 126 Medicare Advantage plans and found that 35 of them had disproportionately high numbers of sicker people dropping out. Many seniors cited problems with “coverage of preferred doctors and hospitals” and “access to care.” The GAO is urging the Centers for Medicare and Medicaid Services (CMS) to review disenrollment data by health status and disenrollment reasons as part of the agency’s routine monitoring efforts.
“People who are sicker are much more likely to leave [Medicare Advantage plans] than people who are healthier,” James Cosgrove, Director of Healthcare at the GAO, told Kaiser Health News.
David Lipschutz, JD, Managing Attorney at the Center for Medicare Advocacy, called for tighter government oversight of Medicare Advantage plans.
“A Medicare Advantage plan sponsor does not have an evergreen right to participate in and profit from the Medicare program, particularly if it is providing poor care,” Lipschutz told Kaiser Health News.
David Lipschutz, JD (above), Managing Attorney for the Center for Medicare Advocacy, is calling for tighter oversight of Medicare Advantage Plans following a report by the Government Accountability Office (GAO) showing an exodus of sicker patients from some Medicare Advantage plans. (Photo copyright: Center for Medicare Advocacy.)
Threat to Regional Medical Laboratories by Narrow Networks
Dark Daily previously reported on how enrollment shifts from traditional Medicare to Medicare Advantage threaten the financial health of regional clinical labs, which typically lose access to Medicare Advantage beneficiaries. In 2017, one in three (33%) Medicare beneficiaries was enrolled in a private Medicare Advantage plan, reflecting 8% growth (1.4 million beneficiaries) between 2016 and 2017, according to a Kaiser Family Foundation (KFF) report.
Medicare Advantage’s private health plans are attractive to many seniors because of lower cost sharing and expanded benefits, such as hearing aid and eyeglass coverage and fitness club memberships. The tradeoff, however, requires forfeiting access to Medicare Part A (hospital insurance) and Part B (medical insurance) and accepting a narrower network of providers and hospitals.
An analysis by the Kaiser Family Foundation shows that more than three in 10 (35%) of Medicare Advantage enrollees in 2015 were in narrow-network plans. On average, Medicare Advantage networks included less than half (46%) of physicians in a county. The size and composition of Medicare Advantage Provider networks greatly impacts smaller clinical laboratories and anatomic pathology groups, which often are excluded from narrow-network plans. (Image copyright: KFF.)
Ron Brandwein, Health Insurance Information, Counseling and Assistance Program Coordinator at Lifespan of Greater Rochester, N.Y., believes consumers need to understand the limitations of Medicare Advantage plans.
“It’s very competitive, very dog eat dog,” he told the Democrat and Chronicle, adding that, once a person signs up with a Medicare Advantage plan, all their dollars for care are sent to that plan. “If they wind up going to a doctor or hospital that doesn’t accept it, they can’t fall back on Medicare because Medicare won’t pay their bills anymore because they’ve given their dollars to their chosen Advantage plan,” he said.
The 2017 KFF report “Medicare Advantage: How Robust Are Plans’ Physician Networks,” found:
- One in three Medicare Advantage enrollees in 2015 were in a plan with a narrow physician network (less than 30% of physicians in the county);
- 43% were in medium-sized networks (30% to 69% of physicians in the county); and,
- Just 22% were in broad plans that included 70% or more of physicians in the county.
“Insurers may create narrow networks for a variety of reasons, such as to have greater control over the costs and quality of care provided to enrollees in the plan,” KFF reported. “The size and composition of Medicare Advantage provider networks is likely to be particularly important to enrollees when they have an unforeseen medical event or serious illness. However, accessing the information may not be easy for users, and comparing networks could be especially challenging. Beneficiaries could unwittingly face significant costs if they accidentally go out-of-network.”
But Kristine Grow, Senior Vice President, Communications, at America’s Health Insurance Plans (AHIP), contends most consumers are satisfied with their Medicare Advantage plans, as evidenced by the growth in Medicare Advantage enrollment. She told Kaiser Health News that patients in the GAO study mostly switched from one health plan to another to take advantage of a better deal or more inclusive coverage.
“We have to remember these are plans working hard to deliver the best care they can,” Grow said. Insurers compete vigorously for business and “want to keep members for the longer term,” she added.
Smaller Clinical Laboratories at Greatest Risk
The implications for anatomic pathology groups and medical laboratories is clear. As Dark Daily has reported, increasing reliance by insurers on narrow networks to stem raising costs limits the number of physicians ordering medical testing, reducing lab revenues and threatening the entire pathology industry—especially smaller clinical laboratories. And, since Medicare patients now represent more than 50% of all patients in the healthcare system, the impact of that aging population’s behavior increases each year.
—Andrea Downing Peck
Related Information:
As Seniors Get Sicker, they’re More Likely to Drop Medicare Advantage Plans
Medicare Advantage 2018 Data: First Look
Medicare Choices More Complicated for Seniors Who Use Rochester Regional Health
Medicare Advantage: How Robust Are Plans’ Physician Networks?
Medicare Advantage Plans in 2017: Short-term Outlook is Stable
Medicare Advantage: CMS should Use Data on Disenrollment and Beneficiary Health Status to Strengthen Oversight
Sustained Growth in Medicare Advantage Plans Threatens Financial Health of Smaller Pathology Groups and Local Medical Laboratories
Kaiser Family Foundation Study Predicts Big Increases in Obamacare Premiums for 2017; However, Narrow Networks Often Exclude Clinical Laboratories and Other Providers
McKinsey Study Confirms Trend Toward Narrow Healthcare Networks on Health Insurance Exchanges; Smaller Clinical Laboratories and Pathology Groups Often Excluded
Narrow Networks Mean Shrinking Opportunity for Pathology and Clinical Medical Laboratories
Feb 12, 2018 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing
Doctors’ advocacy organization praises potential of ‘My Health Record’ but voices concerns about functionality, interoperability, and added burden placed on providers
Australia’s goal of implementing a nationwide electronic health record (EHR) system received a major boost when the country’s largest pathology laboratories signed agreements with the Australian Digital Health Agency (ADHA) to join the project. But the My Health Record system has yet to fully win over providers as the Australian Medical Association (AMA) raises concerns over functionality, interoperability, and the added burden placed on healthcare providers.
ADHA Chief Executive Tim Kelsey praised the addition of pathology and diagnostic organizations to the My Health Record platform. In Australia, pathology laboratory is the term to describe what are called clinical laboratories in the United States.
“The largest diagnostic organizations in Australia have now agreed to share their test reports with Australian consumers,” Kelsey said in an ADHA news release. “We are working to deliver a My Health Record for all Australians next year, unless they choose not to have one. Health consumers will benefit from this significant commitment by the pathology industry and their software partners.”
Australian Digital Health Agency CEO Tim Kelsey says his agency in 2018 will be creating a universal electronic health record for all the country’s 24.8 million citizens, though patients will have the option to opt out of the My Health Record project. He called the “significant commitment” of pathology labs to the project a major step forward. (Photo copyright: ADHA.)
In May 2017, Sonic Healthcare, Australia’s largest pathology provider, became the first private pathology company to join the My Health Record initiative. That news was followed by agreements between the ADHA and pathology companies Primary Health Care, Australian Clinical Labs, and seven other software vendors and pathology laboratories, including:
The ADHA also finalized service agreements with additional software companies that will enable diagnostic imaging providers to link up to My Health Record by the end of 2018.
AMA Says My Health Record Lacks Functionality and Critical Features
In 2012, Australia announced the roll out of the Personally Controlled Electronic Health Record, the original initiative to create a citizen-controlled secure online summary of health information, which later was renamed My Health Record. According to The Australian, more than 5.3 million Australians are now using My Health Record, a 500% increase in the number of shared health summaries uploaded in 2016-2017 and a 200% rise in interoperability with private hospitals.
Royal College of Pathologists of Australasia President Bruce Latham, MBBS, welcomed the announcement of the increased functionality for My Health Record.
“The Australian pathology sector has been working in support of the national eHealth agenda for a number of years,” Latham stated in the ADHA news release. “Work is now progressing to connect both public and private labs to the My Health Record, and patients nationally will start to see their pathology reports in their My Health Record.”
Developers and program administrators of My Health Record predict it will generate savings of AU$123 million from:
- Reduction in adverse drug events;
- Fewer duplicated diagnostics tests; and,
- Cost savings by 2020-2021.
However, the AMA, Australia’s doctors’ advocacy group, outlined its concerns about My Health Record in a Pre-Budget Submission to the Australian federal government. While praising the project’s potential to “not only save money, but save lives,” the AMA argued the national repository of healthcare information needs improved features and functionality to meet its potential.
“… more work is required,” the AMA wrote. “The return on investment will hinge in the short term on ease of use for medical practitioners who upload the clinical data. Interoperability with the multiple software packages used across the medical profession and broader health sector must be seamless.
“Problems uploading specialists’ letters, poor search functionality, time-consuming adaptations to existing medical practitioner work practices, or inappropriate workarounds will erode clinical utility and deter doctor use—and, more importantly, take time away from focusing on the patient,” the AMA concluded.
Automatic Enrollment Concerns AMA
My Health Record began as a self-register model, but as the program goes nationwide in 2018, it will do so using an “opt-out” model. This means citizens will be enrolled automatically unless they ask to be removed from the program. According to the ADHA, the automatic creation of My Health Record for all Australians will begin in mid-2018. The government’s goal is to provide access to My Health Record to all 24.6 million Australians by June 30, 2018.
The federal government’s switch to an opt-out system for My Health Record drew concerns from the AMA.
“Doctors do not have time to talk their patients through the My Health Record arrangements for opt-out, privacy, [or] setting access controls in standing consent for health providers to upload health information. This is the work of the government. Doctors must be allowed to focus on what they do best—caring for patients,” the AMA stressed.
Clinical Laboratories Have Stake in Outcome
According to Healthcare IT News Australia, the Australian government has spent AU$2 billion ($1.53 billion USD) so far developing what could become a white elephant if general practitioners and hospital groups don’t see a clinical benefit in its use.
If Australia is successful in creating a fully-functioning and widely-used national repository for health information, it will be among the first countries to do so. In 2002, the United Kingdom (UK) kicked off a nearly decade-long effort to create a national EHR system for the UK’s single-payer tax-supported health system. Ultimately, the government pulled the plug on the initiative after spending 12.7 billion pounds ($17 billion USD) trying to complete the project.
That result, and lessons learned from Australia’s experience, should inform American healthcare policy makers. It remains a daunting effort to implement a single electronic patient health records system. Of course, pathologists and clinical laboratory administrators have an interest in this issue, since medical laboratory test data represents the largest proportion of an individual patient’s permanent health record.
—Andrea Downing Peck
Related Information:
Australia’s Largest Pathology Labs Sign Up to My Health Record
Private Pathology Reports to Go Live in My Health Record
E-health Revolution Gather Pace as more Services Pledge their Backing
Australian Medical Association Pre-Budget Submission 2018-19
National Expansion of My Health Record in 2018 Confirmed in Budget Announcement
GPS and Hospitals Claim My Health Record Not Fit for Purpose as Alarming Low Usage Figures Are Released
