News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

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

CDC reports more than 93-million US adults are obese, and health issues related to obesity include heart disease, stroke, type 2 diabetes, and cancers

In recent years, the role of the human microbiome in weight loss or weight gain has been studied by different research groups. There is keen interest in this subject because of the high rates of obesity, and diagnostic companies know that development of a clinical laboratory test that could assess how an individual’s microbiome affects his/her weight would be a high-demand test.

This is true of a study published this year in Mayo Clinic Proceedings. Researchers at Mayo Clinic looked at obese patients who were in an active lifestyle intervention program designed to help them lose weight. It was determined that gut microbiota can have a role in both hindering weight loss and supporting weight loss.

Gut Microbiota More Complicated than Previously Thought

The Mayo researchers determined “an increased abundance of Phascolarctobacterium was associated with [successful weight loss]. In contrast, an increased abundance of Dialister and of genes encoding gut microbial carbohydrate-active enzymes was associated with failure to [lose] body weight. A gut microbiota with increased capability for carbohydrate metabolism appears to be associated with decreased weight loss in overweight and obese patients undergoing a lifestyle intervention program.”

How do bacteria impede weight loss? Vandana Nehra, MD, Mayo Clinic Gastroenterologist and co-senior author of the study, explained in a news  release.

“Gut bacteria have the capacity to break down complex food particles, which provides us with additional energy. And this is normally is good for us,” she says. “However, for some individuals trying to lose weight, this process may become a hindrance.”

Put another away: people who more effectively metabolized carbohydrates were the ones who struggled to drop the pounds, New Atlas pointed out.

Vandana Nehra, MD (left), and Purna Kashyap, MBBS (right), are Mayo Clinic Gastroenterologists and co-senior authors of the Mayo study. “While we need to replicate these findings in a bigger study, we now have an important direction to pursue in terms of potentially providing more individualized strategies for people who struggle with obesity,” Nehra noted in the news release. Thus, precision medicine therapy for obese individuals could be based on Mayo Clinic’s research. (Photo copyright: Mayo Clinic.)

Mayo Study Provides Clues to Microbiota Potential in Weight Loss

The Mayo researchers wanted to know how gut bacteria behave in people who are trying to lose weight.

They recruited 26 people, ranging in age from 18 to 65, from the Mayo Clinic Obesity Treatment Research Program. Fecal stool samples, for researchers’ analysis, were collected from participants at the start of the three-month study period and at the end.  The definition of successful weight loss was at least 5% of body weight.

Researchers found the following, according Live Science:

  • 2 lbs. lost, on average, among all participants;
  • Nine people were successful, losing an average of 17.4 lbs.;
  • 17 people did not meet the goal, losing on average just 3.3 lbs.; and,
  • More gut bacterial genes that break down carbohydrates were found in stool samples of the unsuccessful weight loss group, as compared to the successful dieters.

The researchers concluded that “An increased abundance of microbial genes encoding carbohydrate-active enzyme pathways and a decreased abundance of Phascolarctobacterium in the gut microbiota of obese and overweight individuals are associated with failure to lose at least 5% weight following a 3-month comprehensive lifestyle intervention program.”

Purna Kashyap, MBBS, Mayo Clinic Gastroenterologist and co-senior author of the study, told Live Science, “The study suggests there is a need to take the microbiome into account in clinical studies (on weight loss), and it also provides an important direction to pursue in terms of providing individualized care in obesity.” The very basis of precision medicine.

Future Weight-Loss Plans Based on Patient’s Microbiota

The Mayo Clinic researchers acknowledged the small sample size and need for more studies with larger samples over a longer time period. They also noted in their paper that Dialister has been associated with oral infections, such as gingivitis, and its role in energy expenditure and metabolism is unclear.

Still, the study suggests that it may soon be possible to give people individualized weight loss plans based on their gut bacteria. Clinical laboratory professionals and pathologists will want to stay abreast of follow-up studies and replication of findings by other research teams. A future medical laboratory test to analyze patients’ microbiomes could help obese people worldwide as well as lab business volume.

—Donna Marie Pocius

Related Information:

Gut Microbial Carbohydrate Metabolism Hinders Weight Loss in Overweight Adults Undergoing Lifestyle Intervention with a Volumetric Diet

Gut Microbiota from Twins Discordant for Obesity Modulate Metabolism in Mice

CDC: Adult Obesity Facts

Makeup of an Individual’s Gut Bacteria May Play Role in Weight Loss, Mayo Study Suggests

Struggle to Lose Weight? Your gut Bacteria May Be to Blame

Your Gut Bacteria May Make It Harder to Lose Weight

Diet Hit a Snag? Your Gut Bacteria May be Partly to Blame

Can’t Lose Weight? Your Gut Bacteria Could be to Blame, According to Study

Richness of Human Gut Microbiome Correlates with Metabolic Markers

Annual Medical Spending Attributable to Obesity: Payer- and Service-Specific Estimates

5 Ways Gut Bacteria Affect Your Health

Cornell Researchers Identify Gut Microbes That May Help Some People Remain Thin; Findings Could Result in Clinical Laboratory Tests to Analyze Microbiomes of Individuals

Clinical Laboratories Might Soon be Diagnosing Obesity and Guiding Therapies that Utilize Engineered Microbes

Some Hospitals Launch Concierge Care Clinics to Raise Revenue, Generating both Controversy and Opportunity for Medical Laboratories

Critics are quick to note that this creates a disparity in how patients access healthcare services

Independent concierge care (AKA concierge medicine) is available to anyone willing to pay the additional costs, which are over and above any health insurance. In a concierge care medical practice, patients pay an annual retainer fee to gain increased access to doctors, specialists, and services, such as faster TATs on clinical laboratory testing.

Depending on the program, concierge care also can offer patients a range of “improved” healthcare benefits, including same-day appointments, extended appointment times, around-the-clock telehealth services, and the experience of receiving care from a physician with a smaller patient roster and in a more personalized manner.

Clinical laboratories and anatomic pathology groups might also find benefit from the concierge care model. Though some concierge providers bill insurance, most work on a cash basis with payment due upfront for services. This ensures prompt payment for any medical laboratory testing provided, reduces administrative overhead, and eliminates the need to deal with payers.

Concierge Medicine Is Not Just for the Wealthy Anymore

Since its inception, concierge care has been considered a luxury available to only financially well-off patients. However, that may soon change. Several major health systems and hospitals are piloting scaled-back versions of concierge care aimed at both middle- and upper-class consumers. However, the programs are not without critics and have elicited both positive and negative responses from healthcare providers.

According to Modern Healthcare, hospitals and health systems currently testing concierge care programs include:

Patients with busy schedules or chronic conditions may see the biggest gains from investing in concierge care. The added flexibility and increased access might allow them to take advantage of care options more frequently. Physicians being able to take their time during consultations and more closely focus on specific concerns is also seen as a benefit to patients.

However, Modern Healthcare points out that patients are not the only ones to see benefits from this arrangement.

“Doctors who have switched to concierge-style medicine sing its praises, claiming the smaller patient panel allows the doctor to build relationships with patients and spend more time on preventive medicine,” Modern Healthcare noted.

In 2016, Dark Daily reported on similar findings from the American Academy of Private Physicians (AAPP). They noted that the average primary care physician in the US maintained between 2,000 and 4,000 patients using the traditional care model. In contrast, the AAPP found concierge physicians maintained on average only 600 patients. (See, “Concierge Medicine Increases in Popularity as More Consumers Opt for This Care Model; Will Clinical Laboratories Exploit This Business Opportunity?” May 6, 2016.)

Paul-Huang-MD-PhD-Mass General-500w@96ppi

Paul Huang, MD, PhD (above right), a concierge doctor at Massachusetts General Hospital, told Modern Healthcare, “We are not doing this just to make more money—we are doing this to make money to put back into the mission of the hospital and to support programs that otherwise would be difficult to support.” (Photo copyright: Modern Healthcare.)

Concierge Care: Controversial Approach or Major Boon to Hospitals?

Since its debut in the 1990s, concierge care has faced scrutiny and opposition from those who feel it discriminates against those who cannot afford retainer premiums and out-of-pocket expenses.

One health system that has drawn such criticism is Michigan Medicine (MM), which is owned by the University of Michigan. As reported by the Detroit Free Press, in a letter to hospital administration, 200 of MM’s own doctors and staff expressed their feelings about the concierge care program, stating, “Victors Care purports to offer ‘better’ healthcare to those with enough money to pay a large access fee. The University of Michigan is a public institution and our commitment is to serve the public, not a private few. We do not feel this is the role of a state university and are unable to justify this to the patients and families we serve.”

Tom Cassels, a consulting partner with the Advisory Board Company, told Modern Healthcare, “It’s a cultural learning curve, because most not-for-profit health systems are geared toward providing the same level of service to everyone in their community. The fundamental model of concierge medicine is to price-discriminate.”

However, media coverage also highlights how the hospitals creating concierge care services are using the financial benefits to help offset the cost of low-margin services or provide care to low-income patients who wouldn’t otherwise have access to care.

Misty Hathaway, Senior Director of the Center for Specialized Services at Mass General, explained to Modern Healthcare that since their physicians are salaried, margins from concierge services can help support “things like our substance abuse program, or other parts of primary care where the margin is a little bit harder to achieve.”

Despite the ethical debates, use of concierge care services continues to gain momentum as middle and upper-class patients find the increased quality of care a worthy value proposition. As more options emerge at major healthcare centers, medical laboratories and other service providers might find that this trend also offers an opportunity to increase revenue with a minimal impact on administrative and billing costs.

—Jon Stone

Related Information:

Concierge Care Taking Hold at Some Large, Urban Hospitals

No Appointment? No Problem … For a Price

Exclusive U-M Medical Plan Buys You ‘Better’ Care, Special Access

The Future of Healthcare Could Be in Concierge Medicine

The Doctor Won’t See You Now

Concierge Medicine Increases in Popularity as More Consumers Opt for This Care Model; Will Clinical Laboratories Exploit This Business Opportunity?

More Doctors Consider Concierge Medicine as Healthcare Reform Looms

Concierge Medicine Trend Continues and Creates New Clients for Clinical Pathology Laboratories

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

Onboard cooling system ensures samples remain viable for medical laboratory analysis after three-hour flight across Arizona desert

Clinical laboratories and anatomic pathology groups could soon be receiving blood samples and tissue specimens through the air by medical drone. The technology has been tested successfully in Europe, which Dark Daily reported in July. Now, Johns Hopkins University Medicine (JHUM) has set a record in America for the longest distance drone delivery of viable medical specimens.

In a project to demonstrate the viability of using drones to transport medical laboratory specimens, the Johns Hopkins University team flew a drone with specimens more than 161 miles across the Arizona desert. The goal is to bring autonomous medical delivery drones a step closer to transforming how specimens get transported across long distances, according to a Johns Hopkins press release.

A previous Johns Hopkins study in 2015 proved common and routine blood tests were not affected when medical laboratory specimens were transported in up to 40-minute flights on hobby-sized drones. This latest research provides evidence that unmanned aircraft may be able to successfully and quickly shuttle medical specimens even longer distances between remote hospitals and medical laboratories.

Transporting Clinical Laboratory Samples by Air Can Save Lives

In conducting its most recent study, Johns Hopkins researchers obtained paired chemistry and hematology samples from 21 adults (84 samples in total). One sample from each pair was held at a drone test range in a car with active cooling. Remaining samples were flown for three hours in a drone with a Johns Hopkins-designed onboard payload-cooling system to maintain temperature control in the hot desert environment.

A temperature-controlled specimen transport container (above) designed by the Johns Hopkins University research team ensured the blood samples remained cooled and were viable for testing after the three-hour drone flight in the Arizona heat. The project demonstrated the viability of using drones to transport medical laboratory specimens. (Photo copyright: Johns Hopkins Medicine.)

After the 161-mile flight, all samples were transported 62 miles by car to the Mayo Clinic in Scottsdale, Ariz., for testing. Flown and not-flown paired samples showed similar results for red blood cell, white blood cell and platelet counts, and sodium levels, among other results. Only glucose and potassium levels revealed minor but statistically significant differences in results.

Pathologist Timothy Amukele, MD, PhD (above), led a team of researchers at Johns Hopkins University School of Medicine that set a new distance delivery record for medical drones after successfully transporting human blood samples 161 miles across the Arizona desert. The test flight adds to the growing evidence that unmanned aircraft may be the most effective way to quickly transport blood and other medical samples to clinical laboratories. (Photo copyright: Johns Hopkins Medicine.)

In a report of the findings published in the American Journal of Clinical Pathology (AJCP), the research team concludes that long drone flights at high temperature “do not appear to affect the accuracy of 17 of the 19 test types in this study.” However, they note, “Time- and temperature-sensitive analytes such as glucose and potassium will require good pre-planning and stringent environmental controls to ensure reliable results.”

The John Hopkins team believes their achievement adds to mounting evidence that drone transportation can transform the delivery of clinical laboratory specimens.

“We expect that in many cases, drone transport will be the quickest, safest, and most efficient option to deliver some biological samples to a laboratory from rural or urban settings,” stated Timothy Kien Amukele, MD, PhD, Assistant Professor of Pathology at Johns Hopkins University School of Medicine and the paper’s senior author, in a Johns Hopkins Magazine article.

“Getting diagnostic results far more quickly under difficult conditions will almost certainly improve care and save more lives,” Amukele added.

Full Drone Delivery Network Operating Over Switzerland

Medical drones are rapidly moving from demonstration projects to active use. As Dark Daily previously reported, Switzerland is establishing a delivery network of medical drones in the city of Lugano. In March 2017, drone logistics system developer Matternet, based in Menlo Park, Calif., received authorization from the Swiss Federal Office for Civil Aviation (FOCO) for full operation of drone logistics networks over densely populated areas in Switzerland. Working in partnership with Swiss Post (Switzerland’s postal service) and the Ticino EOC hospital group, Matternet successfully completed roughly 100 drone transport test flights between two of Ticino EOC’s hospitals in Lugano.

Another major player in medical drone delivery is Zipline, a Silicon Valley-based drone delivery company that since October 2016 has flown more than 14,000 flights in Rwanda, delivering 2,600 units of blood. The company’s foothold in Africa expanded in August when Tanzania announced it was partnering with Zipline to launch the “world’s largest drone delivery service to provide emergency on-demand access to critical and life-saving medicines.” Tanzania will establish four distribution centers that will use more than 100 drones to make up to 2,000 flights a day.

The emergence of medical drones not only could speed up diagnoses for patients in remote regions of the world and rural communities, but also could revolutionize anatomic pathology specimen deliveries to clinical laboratories in urban areas by providing a faster, more reliable and lower-cost delivery option than third-party couriers using ground transportation.

—Andrea Downing Peck

Related Information:

Study Sets New Distance Record for Medical Drone Transport

Drone Transport of Chemistry and Hematology Samples Over Long Distances

Using Drones to Transport Blood Samples Could Speed Diagnosis, Treatment

Drone Carrying Blood Samples Travels 160 Miles in Arizona Desert to Set New Record

Matternet Unveils the Matternet Station

Tanzania Announces World’s Largest National Drone Delivery Network Partnering with Zipline

Drones Used to Deliver Clinical Laboratory Specimens in Switzerland

Biggest Opportunity for Clinical Laboratory Industry is Utilization Management of Lab Tests, But Only If It Is Done Well

Effective medical lab/physician collaborations to improve how lab tests are ordered and used can deliver big improvements in patient outcomes while reducing healthcare costs

Utilization management of clinical laboratory tests may be the single hottest trend in laboratory medicine today. Across the nation, medical laboratory scientists and pathologists are getting out of the lab to collaborate with physicians to meet the common goal of ordering the right test for the right patient at the right time.

“There are two urgent reasons why clinical laboratories and anatomic pathology groups are engaging with clinicians in projects to improve the utilization of lab tests and both involve money,” stated Robert L. Michel, Editor-In-Chief of The Dark Report. “First, an effective project to improve how physicians use lab tests can return immediate savings to both the lab and the parent hospital. Utilization management projects of this type have the goal of reducing or eliminating orders for duplicate tests, unnecessary tests, and outmoded lab assays. For hospital labs with shrinking budgets, the speedy savings that result from these lab test utilization efforts provide welcome relief.

Progressive Medical Laboratories Want to Deliver More Value

“Second, progressive medical laboratories that want to increase the value of their lab testing services to protect budgets and claim a fair share of value-based payments are going one step further,” explained Michel. “These labs are organizing collaborative projects with physicians and hospital administrators to leverage specific lab tests in ways that measurably improve patient outcomes while, at the same time, contributing to sizeable reductions in the overall cost per patient encounter.”

Today, almost every clinical laboratory and pathology group is under significant and sustained financial pressure. Payers continue to reduce the prices they pay for lab tests. Similarly, hospitals and health systems—facing flat or declining volume of inpatients—are pushing budget cuts across all their clinical service lines, including their labs. These trends force lab directors to pursue the twin strategy of cutting costs while increasing revenue.

Better utilization of lab tests is a business and clinical strategy that enables labs to meet both goals. When physicians do a better job of ordering the right test, and following up the lab test results with the right therapies, healthcare costs go down while patient outcomes improve.

Further, with Medicare and private health insurers continuing to move toward value-based reimbursement arrangements, any clinical lab that can step up and help its client physicians achieve documented improvements in patient outcomes has a legitimate claim to fair reimbursement under bundled and budgeted payment arrangements.

Keen Industry Interest in Utilization Management of Clinical Lab Tests

Proof of the keen interest that lab managers have in utilization management of clinical laboratory tests is the fact that a session on this topic was one of the best-attended at this spring’s Executive War College on Lab and Pathology Management.

Speaking first during this session was Tammy Fletcher, Administrator of Value-Based Services for Mayo Medical Laboratories (MML) in Rochester, Minnesota. As physicians and clinical pathologists at the Mayo Clinic develop and demonstrate clinical guidelines and protocols that utilize medical laboratory tests in the most effective way, Fletcher helps provide that information to client labs throughout the United States. This gives her a unique perspective on the best ways that lab managers can support successful lab test utilization management projects.

 

Tammy Fletcher (above), Administrator of Value-Based Services at the Mayo Medical Laboratories (MML), located in Rochester, Minn., is shown speaking at the Executive War College on Laboratory and Pathology Management last May. She is involved in helping the clinical laboratory clients of MML develop and implement effective utilization management programs to improve how physicians use medical laboratory tests. She will be speaking as part of a utilization management webinar that takes place on June 29. (Photo copyright: The Dark Report. Photo by Linda Reineke.)

Fletcher emphasized that, for utilization management initiatives to deliver optimal benefits, labs should follow a road map with five primary elements. They are:

  • Assess and assemble;
  • Message;
  • Education and guidance;
  • Analytics and evidence; and
  • Payer collaboration.

She emphasized that labs should understand how improving utilization of clinical lab tests helps the parent hospital and health system in two important ways. One way is to score higher in assessments by accrediting bodies. The second way is to deliver measurable improvements that meet and exceed the criteria of the health insurers that are key to the institution’s success, including Medicare and Medicaid.

Utilization Management Successes at Minneapolis Health System

Next to speak was Bobbi Jo Kochevar, MBA, MT (ASCP), Director of Diagnostic Services at North Memorial Health Care in Robbinsdale, Minnesota. Her clinical laboratory serves multiple hospitals and an integrated health system. Thus, the lab team has the opportunity to develop utilization management projects that can involve providers in inpatient, outpatient, and outreach settings in ways that contribute to improved patient care.

Bobbi Jo Kochevar (above), MBA, MLS(ASCP), is Director of Care Coordination for Diagnostic and Therapy Services at North Memorial Health Care in Robbinsdale, Minn. In recent years, she and her clinical laboratory team have conducted several utilization management projects involving how physicians order and use medical laboratory tests. These projects have improved patient care while significantly reducing billing denials. Kochevar will be sharing the lessons learned and successes of her lab team’s utilization management projects during Dark Daily’s upcoming webinar on June 29. (Photo copyright: The Dark Report. Photo by Linda Reineke.)

What caught the audience’s attention during this session was Kochevar’s demonstration of how the clinical laboratory was able to engage clinicians in utilization management projects targeting use of such assays as homocysteine and Enterobacteria phage T4 in ways that improved patient care while also meeting payer criteria. The result was improved patient outcomes and a substantial reduction in billing denials because more claims were properly documented at first submission, thanks to improved physician adherence to both the clinical protocols and to documenting compliance to payers’ requirements.

Many Labs Working to Improve Utilization of Medical Laboratory Tests

Because utilization management of lab tests is now a high priority at most clinical labs and pathology groups, Dark Daily is hosting a special webinar that features Tammy Fletcher and Bobbi Kochevar as the speakers titled, “Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value.” The webinar takes place on Thursday, June 29, 2017, at 1PM EDT.

This is a must-attend for clinical pathologists, lab managers, and lab scientists who wants to:

  1. Develop their skills and knowledge in how to design an effective utilization management (UM) project; and
  2. Learn the best method for encouraging physicians and administrators to launch a winning collaboration and implement a UM project.

Fletcher will identify best practices in utilization management projects that she has learned from her work within the Mayo Clinic and with hospitals and health systems throughout the nation. She will discuss the five elements of the utilization management roadmap.

Nine Foundational Competencies in Utilization Management

Most importantly, Fletcher will describe the nine foundational utilization management competencies in detail. These range from leadership support and operations bandwidth to clinical content and knowledge diffusion. You’ll learn the essentials, as well as receive practical advice on specific pitfalls to avoid.

Kochevar will provide you and your lab team with the practical lessons learned from doing multiple, effective utilization management projects within her integrated health system. This is useful, handy knowledge that you can apply immediately.

An important topic that Kochevar will cover involves the five categories of lab test utilization. She will explain what needs to happen differently if a utilization management project is targeting repetitive or duplicate testing versus contraindicated screening and testing. Kochevar will help you understand how to customize a utilization management project to best address the different concerns and patient care improvement opportunities associated with each of the five different categories of lab test utilization.

The webinar on utilization management is ideal for clinical pathologists, lab managers, and anyone working on utilization management teams. It will help beginners understand the basics of working with clinicians on projects to improve lab test utilization while providing actual case studies and advanced techniques for intermediate and advanced practitioners.

To see the agenda and to register, use this link https://ddaily.wpengine.com/webinar/simple-swift-approaches-to-lab-test-utilization-management-proven-ways-for-your-clinical-laboratory-to-use-data-and-collaborations-to-add-value. (Or copy and paste this URL in your browser: https://ddaily.wpengine.com/webinar/simple-swift-approaches-to-lab-test-utilization-management-proven-ways-for-your-clinical-laboratory-to-use-data-and-collaborations-to-add-value.)

 

—Michael McBride 

 

Related Information: 

Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value

Increasing Costs for Genetic Tests are Busting Lab Budgets

Lab Test Utilization Delivers Big Gains at Cleveland Clinic

As Medical Laboratory Test Utilization Grows, Health Insurers Develop Programs to Manage Rising Costs

Naval Medical Center Study Reveals More than One-third of Genetic Tests are Misordered; Clinical Laboratories Critical to Improving Lab Test Utilization

Innovator Hospitals Bring ICUs into the Info Age, Using New Design Approaches that involve Medical Laboratory Tests

By consolidating information, automating data collection, and harnessing new cloud computing technologies, doctors hope to silence the endless array of alarms and inject efficiency and personalization into the critical care experience

Some healthcare experts believe it is time that intensive care units undergo a workflow redesign to improve the quality of care they deliver, while reducing or eliminating design elements that contribute to errors. Clinical laboratories have a stake in this redesign effort, as they provide medical laboratory tests for patients in ICUs.

“What I want to do for the ICU is what Steve Jobs did for the iPhone,” said Peter Pronovost, PhD, MD, in an article published in STAT. Pronovost is working to improve both the flow of information and delivery of care in the ICU of Johns Hopkins Hospital in Baltimore, Maryland. (more…)

;