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

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

Hosted by Robert Michel
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Expected Increase in Demand for Remote Health Monitoring of America’s Elderly Presents Opportunities for Clinical Laboratories to Provide Services

As our population continues to age, the demand increases for more clinical services and medical laboratory tests that cater to the growing needs of senior citizens

Elderly patients represent the fastest growing healthcare demographic in America. Thus, it is no surprise that healthcare professional in the field of Elderly Care are interested in technologies that enable them to remotely monitor the senior citizens under their care.

Telehealth devices, for example, that monitor a patient’s condition and transmits reports/alerts to primary care doctors and clinical laboratories when biomarkers deviate from set parameters, are becoming frontline tools for ambulatory and home-health practices.

Even emergency departments (EDs) are adopting remote-healthcare, as Dark Daily reported in “Community Paramedicine Brings Emergency Care into Patients’ Homes, Could Increase Clinical Laboratory Specimens Collected in These Settings.”

Healthcare and the Aging Consumer

According to the American Association of Retired Persons (AARP), there are more than 108 million people in the United States over the age of 50. This figure includes over 76 million baby boomers, those born between 1946 and 1964. The number of people over the age of 50 is expected to grow by 19 million over the next decade.

At the latest Aging 2.0 OPTIMIZE conference in San Francisco, Jaana Remes, PhD, economist and partner at the McKinsey Global Institute stated, “In healthcare, there is a clear shift in consumption, and its mainly from a consumer we don’t hear a lot about: the aging consumer. There are a lot of attitudes of stereotypes, and they are still less well known,” noted a MobiHealthNews article. “There is more equality, more diversity, they are more likely to be working later, more likely to be single, they are the most educated older generation yet, and they are much more likely to be tech savvy.”  

Remes added it is important that new technology—such as apps, remote-monitoring systems, and platforms for care teams—are designed with the understanding that seniors will use them. “We need to make things that are suitable, particularly for the 75 and older crowd, to customize their needs,” she stated. “Fewer younger people are taking care of their parents.”

Elderly Care is Four-Five Times More Costly

A report by the National Center for Biotechnology Information (NCBI) states that healthcare costs rise exponentially after a person reaches age 50. According to the report, annual healthcare costs for the elderly are four to five times higher than individuals in their teens.

“Life expectancy has changed dramatically in the US, but while people are living longer, they aren’t necessarily living healthier,” stated Bruce Chernof, MD, President and CEO, The SCAN Foundation, in the MobiHealthNews article. “Maybe they are living with higher function and longer, but they are living with more chronic diseases. Where could tech play a role?” The SCAN Foundation is an independent public charity dedicated to improving care for older adults.

Critical Need for Home Health Monitoring Tools

As America’s population ages, the demand for home healthcare services is escalating at significant rates. According to a report from Zion Market Research, the global market for home healthcare services was valued at $229 billion in 2015. The report also states that that number should reach $391 billion by 2021.

Because families are becoming smaller, and a higher percentage of older adults are single than in the past, there is a greater need for caregivers who provide in-home care. Approximately two thirds of persons receiving home healthcare obtain that care from unpaid relatives and friends.

“The need for technology-enabled caregivers and care support goes up,” noted Chernof in the MobiHealthNews article. “So, we have to look mainly at ‘what is the problem I am trying to solve?’”

Fujitsu Laboratories Limited and Fujitsu Ireland Ltd. ran the KIDUKU Project from 2013-2016. The research initiative was designed to “provide monitoring services and assisted independent living for senior citizens and patients who live in smart houses.” (Graphic copyright: Fujitsu Laboratories Limited.)

Since the largest group of healthcare consumers are seniors, it is crucial to create tools that improve their quality of life and the effectiveness of the healthcare they receive. These tools include monitoring services for both healthcare and home care providers.

“On the pure technology side, it’s simple things like a dashboard report that family members can access that indicate what sensors at home they can interact with, enabling them to track patterns at home, so we can have the family get together and talk, rather than having to bring someone in every few weeks or months and try to figure out the problem moving backwards,” stated Lily Sarafan in the MobiHealthNews article. Sarafan is President and CEO of Home Care Assistance in San Francisco.

According to Sarafan, a significant part of senior care and monitoring is creating technology that tracks patient health and includes a personalized approach to care.

“Collecting better data that we can share with our 10,000 referral partners around the country on what’s happening in that white space, what happens in between when someone sees their healthcare provider two or three times per year because of an emergency or a check-up, and now we’re potentially interacting with a patient 24/7 for months or even years,” she stated. “That’s what puts us in the best possible situation to share data across players in the ecosystem and prevent preventable hospital admissions.”

Clinical Laboratories Could Provide Services; Earn Revenue

It might seem like science fiction now, but there may come a day soon when chronic disease sufferers can opt to have sensors implanted that monitor their conditions 24/7 and collect data that gets transmitted automatically to primary care doctors and other healthcare professionals.

When that happens, some innovative medical laboratories will likely develop business models for monitoring remote devices and collecting revenue for providing the service. By combining the collected data from those devices with a patient’s lab test data, they could identify for medical professionals when interventions are needed for certain conditions.

—JP Schlingman

Related Information:

What the Senior and Aging Care Industry Wants from Digital Health Innovators

A Snapshot of Global Innovation in Aging and Senior Care

How to Help Your Elderly Patients Adapt to Healthcare Technology

Community Paramedicine Brings Emergency Care into Patients’ Homes, Could Increase Clinical Laboratory Specimens Collected in These Settings

From Micro-hospitals to Mobile ERs: New Models of Healthcare Create Challenges and Opportunities for Pathologists and Medical Laboratories

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

Pathologists and clinical lab managers can help physicians more effectively select appropriate genetic tests and better interpret results to identify the most appropriate therapies for their patients

Clinical laboratories and pathology groups aren’t the only healthcare providers being scrutinized for cost cutting and workflow efficiencies. Physicians ordering genetic tests are now in the spotlight thanks to a study of genetic test misordering by one healthcare institution.

In her award-winning presentation, “Genetic Testing Costs and Compliance with Clinical Best Practices,” given at the 2016 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG), Kathleen Ruzzo, MD, revealed some startling facts to the attendees. Ruzzo is an obstetrics and gynecology (OB-GYN) resident at the Naval Medical Center (NMC) in San Diego. She and a team of NMC researchers had reviewed all genetic tests ordered during a 3-month period. They found that more than one-third of the genetic tests examined were unnecessary and had led to more than $20,000 in additional healthcare expenditures. This got the attention of the ACOG, which awarded her 1st prize.

Critical Importance of Staying Informed on Genetic Tests

The researchers examined 114 charts that contained billing codes for genetic tests. They evaluated the charts for compliance with practice guidelines and completed a cost analysis of the tests. The tests were classified per GeneReviews guidelines and were labeled as:

  • Appropriate;
  • Misordered/Not Indicated;
  • Misordered/False Reassurance; or
  • Misordered/Inadequate.

GeneReviews is an online database focusing on information, diagnosis, management, and counseling of single-gene disorders. It is published by the National Center for Biotechnology Information.

The researchers found that:

  • 44 of the 114 charts examined (39%) were misordered based on the guidelines;
  • 24 of the tests were labeled as misordered/not indicated;
  • Eight tests were classified as misordered/false reassurance; and
  • 12 tests were determined to be misordered/inadequate.

“We know there is an ever-expanding number of genetic tests available for clinicians to order, and there is more direct marketing to the patient,” stated Ruzzo in an Ob. Gyn. News article. “It can be difficult to stay on top of that as we have so many different clinical responsibilities.”

Dr. Monica A. Lutgendorf (left) and Dr. Kathleen Ruzzo

Kathleen Ruzzo, MD (above right) and Monica Lutgendorf, MD (above left) of the Naval Medical Center in San Diego, reviewed 114 genetic tests ordered during a three-month period. They discovered that 39% of the tests were misordered according to guidelines, costing a total of $75,000. (Photo copyright: Naval Medical Center.)

The actual testing was performed by Laboratory Corporation of America and occurred over a three-month period. The seven common genetic tests that were reviewed were tests for:

The cost analysis of the tests revealed that $20,000 could have been saved by following the GeneReviews guidelines. The total costs affiliated with the 114 tests reached $75,000. Potential savings were thus 26.6% of the total cost of the genetic tests involved in this study. In many clinical settings, if pathologists and medical laboratory managers could help physicians better utilize genetic tests while reducing the cost of such testing by almost 27%, that would be a major contribution. Plus, patients would be getting better care.

Ordering the Right Genetic Test Saves Money and Protects Patients

According to the National Institutes of Health (NIH), costs affiliated with genetic tests can range from less than $100 to more than $2,000 depending on the type and intricacy of the test. The NIH notes that many insurance companies will pay for genetic testing if ordered by a physician.

Ruzzo also shared that many of her cohorts were surprised at the results of the research.

“I think it opened a lot of people’s eyes … to be more meticulous about [genetic] testing and to ask for help when you need help,” she stated in the Ob. Gyn. News article. “Having trained individuals, reviewing genetic tests could save money in the healthcare system more broadly. We could also approve the appropriate testing for the patient.”

Ruzzo did admit there were limitations to the study; the researchers only looked at small amounts of tests for a short period and they did not concentrate on the consequences of the misordering to the patients.

Monica Lutgendorf, MD, Maternal Fetal Medicine Physician at the Naval Medical Center, was one of the coauthors of the paper. In the Ob. Gyn. News article, she described the findings as “a call to action in general for ob-gyns to get additional training and resources to handle the ever-expanding number of [genetic] tests.”

“I don’t think that this is unique to any specific institution. I think this is part of the new environment of practice that we’re in,” Lutgendorf concluded.

Due to the costs of genetic testing and the fact that so many physicians have not been able to keep up with all the latest advances in genetic medicine and testing, misordering will, most likely, continue to be a problem. Nevertheless, pathologists and clinical laboratory managers can serve a crucial role in helping physicians be more effective at selecting the correct genetic tests and assisting them in interpreting results to choose the most appropriate therapies for their patients.

Meanwhile, for those pathologists and medical laboratory professionals interested in developing effective utilization management programs for lab tests, Dark Daily is presenting a special webinar, titled, “Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value.” It will take place on Thursday, June 29, 2017 at 1PM EDT.

For information about this high-value webinar and to register, use this link (or copy this URL and paste into your browser:

—JP Schlingman

Related Information:

More Than One-Third of Genetic Tests Misordered, Study Finds

Genetic Tests Often Overused and Misinterpreted, Sometimes with Tragic Consequences

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

Research Awards Announced for ACOG 2017 Annual Meeting

Unnecessary Genetic Tests Wastes $500 Million Annually

Dental Plaque Could Lead to Clinical Laboratory Testing for Biomarkers to Identify Health Risks

Researchers have found that isolating a particular gene within the oral microbiome can reveal a huge amount of useful diagnostic information about a person’s health

Most people don’t think of dental plaque when they think about clinical laboratories. For the vast majority of people, the only diseases that dental plaque bring to mind are those of the mouth:

periodontitis; and,
dental caries.

Samples that are sent to medical labs and pathology laboratories are more often blood or tissue. However, that could be changing, thanks in part to the work being done at the Oral Microbiome and Metagenomics Research Lab (OMMR) at the University of Toronto. (more…)

California’s Massive Microarray SNP Genotyping Project Processed Genetic Data from More Than 100,000 Volunteers and Characterized 70 Billion Genetic Variants in 14 months

Faster sequencing speed and accuracy could fuel growth of biomarkers and lead to development of new medical laboratory tests and therapeutic drugs

Trailblazing methods used to create a treasure trove of genetic data from 100,000 Californians could pay dividends for clinical laboratories and pathology groups if similar projects identify novel biomarkers and fuel the development of new clinical laboratory tests and therapeutic drugs.

In fact, California is once again in the forefront, this time with a major program to create a big database of genetic data. The program is called the Genetic Epidemiology Research on Adult Health and Aging (GERA). It is a collaboration between the Kaiser Permanente Northern California Research Program on Genes, Environment, and Health (RPGEH) and the Institute for Human Genetics at the University of California, San Francisco (UCSF) that began in 2009. (more…)

To Help Physicians and Patients, Medical Laboratories with BRCA Breast Cancer Tests Are Posting Mutation Data into ClinVar’s BRCA Database

Innovative use of crowdsourcing allows pathologists and genetic scientists to create a sizeable database of BRCA mutations that is accessible to clinicians and patients

There’s a new development in the longstanding battle over proprietary healthcare data versus public sharing of such information. Pathologists and clinical laboratory managers will be interested to learn that, when it comes to genetic testing of the BRCA mutation involved in breast cancer, a public data base of mutations is growing so rapidly that it may become the world’s largest repository of such information.

It was last year when the Supreme Court ruled in the gene patent case of Association of Molecular Pathology versus Myriad Genetics that human genes were not patentable. Following that decision, some financial analysts stated that Myriad Genetics, Inc. (NASDAQ:MYGN) retained a competitive advantage over other medical laboratories due to its huge database of mutations in the BRCA genes. (See Dark Daily, “Supreme Court Strikes down Myriad Gene Patents in Unanimous Vote; Decision Is Expected to Benefit Clinical Pathology Laboratories,”  July 1, 2013.) (more…)