UK Researchers Create Conductive Thread That Can Be Woven into Clothing to Monitor Key Health Biomarkers

Meet ‘PECOTEX,’ a newly-invented cotton thread with up to 10 sensors that is washable. Its developers hope it can help doctors diagnosis disease and enable patients to monitor their health conditions

Wearable biosensors continue to be an exciting area of research and product development. The latest development in wearable biosensors comes from a team of scientists led by Imperial College London. This team created a conductive cotton thread that can be woven onto T-shirts, textiles, and face masks and used to monitor key biosignatures like heart rate, respiratory rate, and ammonia levels.

Clinical laboratory managers and pathologists should also take note that this wearable technology also can be used to diagnose and track diseases and improve the monitoring of sleep, exercise, and stress, according to an Imperial College London news release.

Should this technology make it into daily use, it might be an opportunity for clinical laboratories to collect diagnostic and health-monitoring data to add to the patient’s full record of lab test results. In turn, clinical pathologists could use that data to add value when consulting with referring physicians and their patients.

The researchers published their findings in the journal Materials Today titled, “PEDOT:PSS-modified Cotton Conductive Thread for Mass Manufacturing of Textile-Based Electrical Wearable Sensors by Computerized Embroidery.”

“Our research opens up exciting possibilities for wearable sensors in everyday clothing,” said Firat Güder, PhD, Principal Investigator and Chief Engineer at Güder Research Group at Imperial College London, in a news release. “By monitoring breathing, heart rate, and gases, they can already be seamlessly integrated, and might even be able to help diagnose and monitor treatments of disease in the future.” (Photo copyright: Wikipedia.)

Ushering in New Generation of Wearable Health Sensors

The researchers dubbed their new sensor thread PECOTEX. It’s a polystyrene sulfonate-modified cotton conductive thread that can incorporate more than 10 sensors into cloth surfaces, costs a mere 15 cents/meter (slightly over 39 inches), and is machine washable.

“PECOTEX is high-performing, strong, and adaptable to different needs,” stated Firat Güder, PhD, Principal Investigator and Chief Engineer at Güder Research Group, Imperial College London, in the press release.

“It’s readily scalable, meaning we can produce large volumes inexpensively using both domestic and industrial computerized embroidery machines,” he added.

The material is less breakable and more conductive than conventional conductive threads, which allows for more layers to be embroidered on top of each other to develop more complex sensors. The embroidered sensors retain the intrinsic values of the cloth items, such as wearability, breathability, and the feel on the skin. PECOTEX is also compatible with computerized embroidery machines used in the textile industry.

The researchers embroidered the sensors into T-shirts to track heart activity, into a face mask to monitor breathing, and into other textiles to monitor gases in the body like ammonia which could help detect issues with liver and kidney function, according to the news release.

“The flexible medium of clothing means our sensors have a wide range of applications,” said Fahad Alshabouna, a PhD candidate at Imperial College’s Department of Bioengineering and lead author of the study in the news release. “They’re also relatively easy to produce which means we could scale up manufacturing and usher in a new generation of wearables in clothing.”

Uses for PECOTEX Outside of Healthcare

The team plans on exploring new applications for PECOTEX, such as energy storage, energy harvesting, and biochemical testing for personalized medicine. They are also seeking partners for commercialization of the product.

“We demonstrated applications in monitoring cardiac activity and breathing, and sensing gases,” Fahad added. “Future potential applications include diagnosing and monitoring disease and treatment, monitoring the body during exercise, sleep, and stress, and use in batteries, heaters, and anti-static clothing.”

In addition to Imperial College London, the research was funded by the Saudi Ministry of Education, the Engineering and Physical Sciences Research Council (EPSRC), Cytiva Life Sciences, the Bill and Melinda Gates Foundation, and the US Army.

Other Wearable Biometric Sensors

Dark Daily has covered the development of many wearable health sensors in past ebriefings.

In “UC San Diego Engineers Develop Microneedle Wearable Patch That Measures Glucose, Alcohol, Muscle Fatigue in Real Time,” we covered how “lab-on-the-skin” multi-tasking microneedle sensors like the one developed at the University of California San Diego’s (UCSD) Center for Wearable Sensors to track multiple biomarkers in interstitial fluid were finding their way into chronic disease monitoring and sample collecting for clinical laboratory testing.

In “Fitbit Receives FDA Approval for a Wearable Device App That Detects Atrial Fibrillation,” we reported how personal fitness technology company Fitbit had received 510(k) clearance from the US Food and Drug Administration (FDA), as well as Conformité Européenne (CE marking) in the European Union, for its Sense smartwatch electrocardiogram app that monitors wearers’ heart rhythms for atrial fibrillation (AFib).

And in “Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults,” we reported how researchers at Tokyo University of Science (TUS) had created a self-powered, glucose-testing diaper that utilizes a biofuel cell to detect the presence of urine and measure its glucose concentration.

Wearable Sensors in Personalized Healthcare

Wearable healthcare devices have enormous potential to perform monitoring for diagnostic, therapeutic, and rehabilitation purposes and support precision medicine.

Further studies and clinical trials need to occur before PECOTEX will be ready for mass consumer use. Nevertheless, it could lead to new categories of inexpensive, wearable sensors that can be integrated into everyday clothes to provide data about an individual’s health and wellbeing.

If this technology makes it to clinical use, it could provide an opportunity for clinical laboratories to collect diagnostic data for patient records and help healthcare professionals track their patients’ medical conditions. 

—JP Schlingman

Related Information:

Sensors Embedded into T-Shirts and Face Masks Could Monitor Biosignatures

PEDOT:PSS-modified Cotton Conductive Thread for Mass Manufacturing of Textile-based Electrical Wearable Sensors by Computerized Embroidery

Wearable Sensors Styled into T-shirts and Face Masks

Low-Cost Sensor Tracks Vital Signs and Breath to Monitor Diseases

Sensor Thread

Wearable Sensor

UC San Diego Engineers Develop Microneedle Wearable Patch That Measures Glucose, Alcohol, Muscle Fatigue in Real Time

Fitbit Receives FDA Approval for a Wearable Device App That Detects Atrial Fibrillation

Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults

Northwestern University Study Shares News Insights into Aging Guided by Transcriptome, Gene Length Imbalance

Findings could lead to deeper understanding of why we age, and to medical laboratory tests and treatments to slow or even reverse aging

Can humans control aging by keeping their genes long and balanced? Researchers at Northwestern University in Evanston, Illinois, believe it may be possible. They have unveiled a “previously unknown mechanism” behind aging that could lead to medical interventions to slow or even reverse aging, according to a Northwestern news release.

Should additional studies validate these early findings, this line of testing may become a new service clinical laboratories could offer to referring physicians and patients. It would expand the test menu with assays that deliver value in diagnosing the aging state of a patient, and which identify the parts of the transcriptome that are undergoing the most alterations that reduce lifespan.

It may also provide insights into how treatments and therapies could be implemented by physicians to address aging.

The Northwestern University scientists published their findings in the journal Nature Aging title, “Aging Is Associated with a Systemic Length-Associated Transcriptome Imbalance.”

“I find it very elegant that a single, relatively concise principle seems to account for nearly all of the changes in activity of genes that happen in animals as they change,” Thomas Stoeger, PhD, postdoctoral scholar in the Amaral Lab who led the study, told GEN. Clinical laboratories involved in omics research may soon have new anti-aging diagnostic tests to perform. (Photo copyright: Amaral Lab.)

Possible ‘New Instrument’ for Biological Testing

Researchers found clues to aging in the length of genes. A gene transcript length reveals “molecular-level changes” during aging: longer genes relate to longer lifespans and shorter genes suggest shorter lives, GEN summarized.

The phenomenon the researchers uncovered—which they dubbed transcriptome imbalance—was “near universal” in the tissues they analyzed (blood, muscle, bone, and organs) from both humans and animals, Northwestern said. 

According to the National Human Genome Research Institute fact sheet, a transcriptome is “a collection of all the gene readouts (aka, transcript) present in a cell” shedding light on gene activity or expression.

The Northwestern study suggests “systems-level” changes are responsible for aging—a different view than traditional biology’s approach to analyzing the effects of single genes.

“We have been primarily focusing on a small number of genes, thinking that a few genes would explain disease,” said Luis Amaral, PhD, Senior Author of the Study and Professor of Chemical and Biological Engineering at Northwestern, in the news release.

“So, maybe we were not focused on the right thing before. Now that we have this new understanding, it’s like having a new instrument. It’s like Galileo with a telescope, looking at space. Looking at gene activity through this new lens will enable us to see biological phenomena differently,” Amaral added.

In their Nature Aging paper, Amaral and his colleagues wrote, “We hypothesize that aging is associated with a phenomenon that affects the transcriptome in a subtle but global manner that goes unnoticed when focusing on the changes in expression of individual genes.

“We show that transcript length alone explains most transcriptional changes observed with aging in mice and humans,” they continued.

Researchers Turn to AI, RNA Sequencing

According to their published study, the Northwestern University scientists used large datasets, artificial intelligence (AI), and RNA (ribonucleic acid) sequencing in their analysis of tissue derived from:

  • Humans (men and women), age 30 to 49, 50 to 69, and 70 years and older. 
  • Mice, age four months to 24 months.
  • Rats, age six to 24 months.
  • Killifish, age five weeks to 39 weeks.

Scientific American reported the following study findings:

  • In tissues studied, older animals’ long transcripts were not as “abundant” as short transcripts, creating “imbalance.”
  • “Imbalance” likely prohibited the researchers’ discovery of a “specific set of genes” changing.
  • As animals aged, shorter genes “appeared to become more active” than longer genes.
  • In humans, the top 5% of genes with the shortest transcripts “included many linked to shorter life spans such as those involved in maintaining the length of telomeres.”
  • Conversely, the researchers’ review of the leading 5% of genes in humans with the longest transcripts found an association with long lives.
  • Antiaging drugs—rapamycin (aka, sirolimus) and resveratrol—were linked to an increase in long-gene transcripts.

“The changes in the activity of genes are very, very small, and these small changes involve thousands of genes. We found this change was consistent across different tissues and in different animals. We found it almost everywhere,” Thomas Stoeger, PhD, postdoctoral scholar in the Amaral Lab who led the study, told GEN.

In their paper, the Northwestern scientists noted implications for creation of healthcare interventions.

“We believe that understanding the direction of causality between other age-dependent cellular and transcriptomic changes and length-associated transcriptome imbalance could open novel research directions for antiaging interventions,” they wrote.

Other ‘Omics’ Studies

Dark Daily has previously reported on transcriptomics studies, along with research into the other “omics,” including metabolomics, proteomics, and genomics.

In “Spatial Transcriptomics Provide a New and Innovative Way to Analyze Tissue Biology, May Have Value in Surgical Pathology,” we explored how newly combined digital pathology, artificial intelligence (AI), and omics technologies are providing anatomic pathologists and medical laboratory scientists with powerful diagnostic tools.

In “Swiss Researchers Develop a Multi-omic Tumor Profiler to Inform Clinical Decision Support and Guide Precision Medicine Therapy for Cancer Patients,” we looked at how new biomarkers for cancer therapies derived from the research could usher in superior clinical laboratory diagnostics that identify a patient’s suitability for personalized drug therapies and treatments.

And in “Human Salivary Proteome Wiki Developed at University of Buffalo May Provide Biomarkers for New Diagnostic Tools and Medical Laboratory Tests,” we covered how proteins in human saliva make up its proteome and may be the key to new, precision medicine diagnostics that would give clinical pathologists new capabilities to identify disease.

Fountain of Youth

While more research is needed to validate its findings, the Northwestern study is compelling as it addresses a new area of transcriptome knowledge. This is another example of researchers cracking open human and animal genomes and gaining new insights into the processes supporting life.

For clinical laboratories and pathologists, diagnostic testing to reverse aging and guide the effectiveness of therapies may one day be possible—kind of like science’s take on the mythical Fountain of Youth.  

—Donna Marie Pocius

Related Information:

Aging Is Driven by Unbalanced Genes

Aging Linked to Gene Length Imbalance and Shift Towards Shorter Genes

NIH: Transcriptome Fact Sheet

Aging Is Associated with a Systemic Length-Associated Transcriptome Imbalance

Aging Is Linked to More Activity in Short Genes than in Long Genes

Spatial Transcriptomics Provide a New and Innovative Way to Analyze Tissue Biology, May Have Value in Surgical Pathology

Swiss Researchers Develop a Multi-omic Tumor Profiler to Inform Clinical Decision Support and Guide Precision Medicine Therapy for Cancer Patients

Human Salivary Proteome Wiki Developed at University of Buffalo May Provide Biomarkers for New Diagnostic Tools and Medical Laboratory Tests

Major Breakthrough in Human Genome Sequencing, as Full Y Chromosome Sequencing Completed after a More than 20 Year Journey

Clinical laboratories and pathology groups may soon have new assays for diagnosis, treatment identification, patient monitoring

It’s here at last! The human Y chromosome now has a full and complete sequence. This achievement by an international team of genetic researchers is expected to open the door to significant insights in how variants and mutations in the Y chromosome are involved in various diseases and health conditions. In turn, these insights could lead to new diagnostic assays for use by clinical laboratories and pathology groups.

After decades of attempts, genetic scientists led by the Telomere-to-Telomere Consortium—a team of researchers funded by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH)—have finally “generated the first truly complete sequence of a human Y chromosome,” which is “the final human chromosome to be fully sequenced,” of the 24 human chromosomes, SciTechDaily reported.

Pathologists and clinical laboratories involved in genetic research will understand the significance of this accomplishment. The full Y chromosome sequence “fills in gaps across more than 50% of the Y chromosome’s length, [and] uncovers important genomic features with implications for fertility, such as factors in sperm production,” SciTechDaily noted.

This breakthrough will make it possible for other research teams to gain further understanding of the functions of the Y chromosome and how specific gene variants and mutations contribute to specific health conditions and diseases. In turn, knowledge of those genetic sequences and mutations would give clinical laboratories the assays that help diagnosis, identify relevant therapies, and monitor a patient’s progress.

The researchers published their findings in the journal Nature titled, “The Complete Sequence of a Human Y Chromosome.”

“When you find variation that you haven’t seen before, the hope is always that those genomic variants will be important for understanding human health,” said Adam Phillippy, PhD, a senior investigator and head of the Genome Informatics Section at the National Human Genome Research Institute, in a press release. Clinical laboratories and anatomic pathology groups may soon have new assays based on the T2T study findings. (Photo copyright: National Human Genome Research Institute.)

Study Background and Recognition

Revolutionary thinking by the Telomere-to-Telomere (T2T) scientists led to the team’s breakthrough. The researchers “applied new DNA sequencing technologies and sequence assembly methods, as well as knowledge gained from generating the first gapless sequences for the other 23 human chromosomes,” SciTechDaily reported.

In 1977, the first complete genome of an organism was sequenced. Thus began the commencement of sequencing technology research. Twenty years ago the first human genome sequence was completed. The result was thanks to years of work through the preferred “chain termination” (aka, Sanger Sequencing) method developed by Fred Sanger and a $2.7 billion contribution from the Human Genome Project, according to a study published in the African Journal of Laboratory Medicine (AJLM).

By 2005, a new era in genomic sequencing emerged. Scientists now employed a technique called pyrosequencing and the change had great benefits. “Massively parallel or next-generation sequencing (NGS) technologies eliminated the need for multiple personnel working on a genome by automating DNA cleavage, amplification, and parallel short-read sequencing on a single instrument, thereby lowering costs and increasing throughput,” the AJLM paper noted.

The new technique brought great results. “Next-generation sequencing technologies have made sequencing much easier, faster and cheaper than Sanger sequencing,” the AJLM study authors noted.

The changes allowed more sequencing to be completed. Nevertheless, more than half of the Y chromosome sequence was still unknown until the new findings from the T2T study, SciTechDaily reported.

Why the TDT Breakthrough Is So Important

“The biggest surprise was how organized the repeats are,” said Adam Phillippy, PhD, a senior investigator and head of the NHGRI. “We didn’t know what exactly made up the missing sequence. It could have been very chaotic, but instead, nearly half of the chromosome is made of alternating blocks of two specific repeating sequences known as satellite DNA. It makes a beautiful, quilt-like pattern.”

Phillippy’s research was groundbreaking enough to earn him and his team finalist positions in the 2023 Science, Technology, and Environment segment of the Samuel J. Heyman Service to America Medals.

Much can be gained in knowing more about the Y chromosome. Along with the X chromosome, it is significant in sexual development. Additionally, current research is showing that genes on the Y chromosome are linked to the risk and severity of cancer.

Might What Comes Next Give Clinical Labs New Diagnostic Tools?

The variety of new regions of the Y chromosome that the T2T team discovered bring into focus several areas of new genetic research. For instance, the “azoospermia factor region, a stretch of DNA containing several genes known to be involved in sperm production” was uncovered, and “with the newly completed sequence, the researchers studied the structure of a set of inverted repeats or palindromes in the azoospermia factor region,” SciTechDaily reported.

“This structure is very important because occasionally these palindromes can create loops of DNA. Sometimes, these loops accidentally get cut off and create deletions in the genome,” said Arang Rhie, PhD, a staff scientist at NHGRI and first author of the Nature study.

Missing regions would challenge the production of sperm, impacting fertility, so being able to finally see a complete sequence will help research in this area.

Scientists are only just beginning to recognize the value of this breakthrough to future genetic research and development. As genetic sequencing costs continue to drop, the T2T research findings could mean new treatment options for pathologists and diagnostic assays for clinical laboratories are just around the corner.

—Kristin Althea O’Connor

Related Information:

Complete Human Y Chromosome Sequence Assembled for the First Time

The Complete Sequence of a Human Y Chromosome

Scientists Release the First Complete Sequence of a Human Y Chromosome

Will Long-Read Sequencing Technologies Replace Short-Read Sequencing Technologies in the Next 10 Years?

Researchers Assemble the First Complete Sequence of a Human Y Chromosome

Adam Phillippy Finalist in Samuel J. Heyman Service to America Medals for Science, Technology, and Environment

Retail Pharmacies Are Working with Pharmaceutical Companies to Recruit and Enroll Patients in Decentralized Clinical Trials

This trend, which began during the COVID-19 pandemic, may bypass those clinical laboratories and pathology groups that recruit patients for clinical trials, but increase the diversity of the pool of study participants

National retail pharmacy chains are seeking new lines of business in the healthcare market and their efforts could cost clinical laboratories and pathology groups revenue. Their strategy is to identify patients who are candidates for specific clinical trials and connect them with clinical trial managers for enrollment, according to CNET.

This comes on the back of the US Food and Drug Administration’s (FDA) move to decentralize clinical trials, which got started during the COVID-19 pandemic, and support clinical trials that covered a wider swath of the American population.

Dark Daily first covered this trend in “Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research.” We reported how Walgreens was launching a business to connect customers with clinical drug trials, a venture that adds another offering to the retail pharmacy giant’s growing menu of healthcare services.  

Traditionally, there are clinical laboratories and anatomic pathology groups that actively work to connect their patients with appropriate clinical trials (and earn revenue for both the enrollment and doing necessary testing of the patient in support of the trial). Now, following the FDA’s lead, pharmacy companies seem to be working to capture some of that revenue.

“COVID-19 was definitely the impetus for reevaluating how we did clinical trials,” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, told CNET. The interest of retail pharmacies in the business of identifying their patients as candidates for clinical trials is a development that clinical lab managers and pathologists may want to monitor. (Photo copyright: Walgreens.)

Customer Demand for Convenience a Factor

Clinical trials are imperative to the drug approval process required by the FDA’s Center for Drug Evaluation and Research (CDER). The COVID-19 pandemic fueled the FDA’s move to decentralize clinical trials to help pharmaceutical companies recruit subjects for drug testing.

Retail pharmacy chains apparently saw that as the latest opportunity to position retail pharmacies as intermediaries between drug manufacturers and patients.

In response to growing demand for convenient healthcare locations, Walgreens, CVS, Rite Aid, and Walmart have all installed primary care clinics into their retail pharmacies and added vaccinations. Further, after COVID-19 caused retail pharmacy chains to sell over-the-counter SARS-CoV-2 home test kits, pharmacies sought to offer more diagnostic test options to their customers, which would further direct such tests away from clinical laboratories.

Over the last two years, Walgreens, Walmart, CVS, and Kroger have also added clinical trials divisions to their corporate holdings. Among the companies’ stated goals is to make clinical trials more accessible and convenient for their customers, as well as to recruit more trial participants from underrepresented populations. 

According to an article published in the Journal of Medical Internet Research (JMIR), “around 80% of trials fail to meet the initial enrollment target and timeline, and these delays can result in lost revenue of as much as US $8 million per day for drug developing companies.” This shortfall may delay the creation of useful drugs, medical devices, and other essential treatments. 

“If you see the trial is at an academic institution that’s 30, 40 miles away, you’re going to say, ‘Forget it. It’s too far,’” Ramita Tandon, Chief Clinical Trials Officer at Walgreens, told CNET. “But if you can go to a Walgreens that’s maybe five miles away, you’re more likely to participate and complete the trial.”

Creating a More Diverse Group of Clinical Trial Participants

CNET reported that “Pfizer, Gilead, and other biopharmaceutical companies are eager to diversify their patient pool.”

According to the FDA’s 2022 Drug Trials Snapshot, “Whites comprised the majority of patients enrolled in most of the pivotal trials supporting approval of all 37 novel therapies, followed by Asians and Blacks.”

Walgreens, which operates 8,698 pharmacies in 53 states and territories, has installed special clinical trial centers at 15 pharmacies and has approximately one dozen clinical trials in various stages. Tandon said more than two million Walgreens customers have already been contacted about participating in clinical trials.

In January, grocery giant Kroger announced its first clinical trial partnership with Persephone Biosciences to locate subjects for a study on gut health and its influence on colorectal cancer. Data collected from this trial will help develop personalized medicines and discover cancer-specific indicators that may be beneficial in guiding treatments and preventative measures. 

Kroger Health operates nearly 2,200 pharmacies across the US, including 11 specialty pharmacies and 225 clinics.

In October of last year, Walmart announced the creation of the Walmart Healthcare Research Institute (WHRI), which will focus on innovative interventions and medications to help communities that are unrepresented in clinical trials, such as older adults, rural residents, women and minority populations.

Walmart operates over 3,000 pharmacies in 49 states. Ninety percent of Americans live within ten miles of a Walmart, which translates to the retailer being able to reach a large number of candidates for clinical trials.

Study findings published by marketing research company Precedence Research illustrate how the business of clinical trials generated more than $48 billion last year and is projected to reach over $83 billion by 2032. (Graphic copyright: Precedence Research.)

CVS Discontinues Decentralized Clinical Trial Business

CVS Health was the first pharmacy to launch a clinical trials program back in May 2021. However, in May of this year, the company announced it was shuttering that portion of its business.

CVS Health expects to fully phase out its clinical trials unit by the end of 2024, citing “the need to align existing businesses with its larger corporate strategy,” according to BioSpace.

“Fully decentralized models preclude a huge swath of possible research because of safety and regulatory concerns,” Steve Wimmer, Vice President of Partnerships at decentralized clinical trial recruiter 1nHealth, told BioSpace. “It’s difficult to conduct such trials in a standardized manner. I think [CVS] may have imagined that a clinical study visit wouldn’t be that different from the primary care visits they already do. But for interventional, go-to-study trials, it’s not the same as a primary care visit.”

According to the US National Library of Medicine, more than 38,000 registered clinical studies occurred in 2022. As of August 24 of this year, 26,237 clinical studies have been registered on clinicaltrials.gov

There are clinical laboratories and anatomic pathology groups that actively work to connect their patients with those clinical trials. Though pharmacy companies’ clinical trial recruitment programs may reduce revenue for those labs and pathologists, the increased participation in such trials by greater numbers and more diverse populations of people could advance the development of new lifesaving treatments and therapies, which is good for everyone.  

—JP Schlingman

Related Information:

Clinical Trials Are Now at Your Local Drugstore. What That Means for You

Walgreens Launches Clinical Trial Business with Goal of Leveraging Consumer Data, Technology, and Nationwide Reach to Increase Racial and Ethnic Diversity in Drug Research

FDA: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

FDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

US National Library of Medicine: Trends, Charts, and Maps

Healthcare Clinical Trials Market

Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis

FDA: Drug Trials Snapshots Summary Report 2022

Kroger Health Establishes Clinical Trial Site Network to Increase Reach and Access to Research Studies

Walmart’s Healthcare Research Institute Launches with Mission to Improve Care for Underserved Communities Through Research

CVS Health Winding Down Clinical Trial Business  

CMS Proposes New Amendments to Federal Hospital Price Transparency Rule That May Affect Clinical Laboratories and Pathology Groups

Proposal comes as patient advocacy group reports poor compliance by hospitals with the federal price transparency regulation; AHA pushes back

Recent data compiled by Patient Rights Advocate, a non-profit group dedicated to nationwide healthcare transparency, appears to indicate that as many as two thirds of US hospitals continue to ignore hospital transparency rules established by Congress in 2021, according to an op-ed published in the Washington Examiner.

This may be why the Biden Administration has now proposed new amendments aimed at strengthening those requirements. According to KFF Health News (formerly Kaiser Health News), this new proposal “aims to further standardize the required data, increase its usefulness for consumers, and boost enforcement.”

However, “the goal of exact price tags in every situation is likely to remain elusive,” KFF Health News noted.

“Noncompliant hospitals are preventing patients and payers from shopping around for high-value care—and inflating healthcare costs in the process,” wrote Sally C. Pipes, President and CEO of Pacific Research Institute, in her Washington Examiner column.

Pathologists who were near the top of a Health Care Cost Institute (HCCI) list of medical specialties that most often billed out of network may be affected by CMS’ proposed new amendments to the transparency rule.

“The nonprofit group Patient Rights Advocate just published its fifth report exploring how hospitals are complying with federal price transparency requirements. About two-thirds are still flouting the rules. That’s unacceptable,” wrote Sally Pipes (above), President and CEO of Pacific Research Institute, in an op-ed she penned for the Washington Examiner. Federal law also requires clinical laboratories to post their prices for testing. (Photo copyright: The Heartland Institute.)

Hospitals, Clinical Laboratories Required to Post Chargemaster Prices

The proposed amendments were part of a larger proposed rule published in the July 31, 2023, Federal Register by the Centers for Medicare and Medicaid Services (CMS).

Dark Daily has long been reporting on the federal government’s efforts to mandate Hospital Price Transparency (HPT). Beginning Jan. 1, 2019, hospitals have been required to post pricing information on their websites, as Dark Daily reported in “New CMS Final Rule Makes Clinical Laboratory Test/Procedure Pricing Listed on Hospital Chargemasters Available to Public.”

That rule required hospitals to disclose chargemaster prices, essentially the “list prices” for hospital procedures.

But a year later, as we reported in “Hospital Associations and Healthcare Groups Battle HHS Efforts to Expand Pricing Transparency Rules to Include Negotiated Rates with Payers,” the CMS passed a final rule that required disclosure of prices negotiated with payers.

That rule also required hospitals to provide a list of charges for at least 300 “shoppable services,” including at least 14 laboratory and pathology tests.

“We’re closer to that, but we’re not there,” Gerard Anderson, PhD, a professor at the Johns Hopkins Bloomberg School of Public Health, told KFF. The goal may be the kind of pricing transparency that consumers are accustomed to when purchasing goods and services, but healthcare, he said, poses unique challenges.

“Each patient is unique and uses a slightly different bundle of services,” Anderson added. “You might be in the operating room for 30 minutes, or it might be 45. You might need this lab test and not that one.”

The KFF Health News story noted that health insurers have been subject to even stricter regulations, “with more prescriptive details and tougher penalties for noncompliance,” since 2022. CMS’ latest proposed amendments would bring requirements for hospitals that are more in line with those that apply to payers, KFF reported.

As described in the Federal Register, the proposed rule aims to:

  • Improve standardization of machine-readable file (MRF) formats and data elements.
  • Require hospitals to include a new data element known as the “consumer-friendly expected allowed charges,” KFF Health News noted.
  • Require hospitals to “affirm the accuracy and completeness of their standard charge information displayed in the MRF.”
  • Require hospitals to place a link to pricing information in the footers of their web pages.

The rule also includes provisions for enhanced enforcement of pricing transparency requirements. Under one proposal, CMS would publicly identify hospitals that are not in compliance.

Jeffrey Leibach, MBA, a healthcare finance strategist and Partner with the consulting firm Guidehouse, told KFF Health News that the new rules will make it easier for third-party data firms to create online price comparison tools. “And, ultimately, consumers who want to shop will then find this data more easily,” he said.

The proposal comes on the heels of a July report from Patient Rights Advocate (PRA) indicating that only 36% of US hospitals were in full compliance with the current transparency requirements. The report was based on an analysis of 2,000 hospital websites. However, that was an improvement over earlier reports. In February, the group reported that 24.5% were fully compliant, compared with 16% in August 2022.

Most hospitals in the report posted negotiated prices, but in many cases, “their pricing data was missing or significantly incomplete,” PRA contended. A total of 69 hospitals “did not post a usable standard charges file,” the report stated.

PRA Uses Humor to Highlight Discrepancies, AHA Pushes Back

According to KFF Health News, PRA is running a satirical ad campaign in which retailers adopt the “hospital pricing method,” listing estimates on store shelves instead of actual prices.

“When they ask for a price, we give them an estimate,” says one retail manager in the video ad. “Then we bill them whatever we want.”

This new video pokes fun at the lack of price transparency in healthcare. The American Hospital Association took issue with the clip’s tone.

“People need price certainty,” PRA founder and Chairman Cynthia Fisher, MBA, told KFF Health News. “Estimates are a way of gaming the people who pay for healthcare.”

However, executives from the American Hospital Association (AHA) pushed back on the video ad and PRA’s claims about HPT compliance. AHA contends that hospitals were flagged as being noncompliant if they left spaces blank or used formulas, both of which are permitted under the current rules.

“Very few health services are so straightforward where you can expect no variation in the course of care, which could then result in a different cost than the original assessment,” AHA Group Vice President for public policy Molly Smith, MS, told KFF. “Organizations are doing the best they can to provide the closest estimate. If something changes in the course of your care, that estimate might adjust.”

As for the July PRA report, in a July 25 AHA press release, Smith stated, “Patient Rights Advocate has put out a report that blatantly misconstrues, ignores, and mischaracterizes hospitals’ compliance with federal price transparency regulations.”

CMS, she said, “has found that as of last year 70% of hospitals had complied with both federal requirements and over 80% had complied with at least one. Due to the ongoing efforts of the hospital field, these numbers are surely higher today. Third party analyses have agreed that hospitals have made tremendous progress.”

But then what is motivating the government’s new amendments to the price transparency rule? Regardless, clinical laboratories and pathology groups should continue to monitor progress of these new amendments to the federal hospital transparency rule.

—Stephen Beale

Related Information:

Hospitals Are Still Neglecting Transparency Rules

Proposed Rule Would Make Hospital Prices Even More Transparent

CMS Proposes Updates to the Hospital Price Transparency Rule

A Progress Check on Hospital Price Transparency

Price Transparency: A Boon For Patients, a Bust for Hospitals?

Just More than a Third of Hospitals Are Complying with Price Transparency Rules

Calgary’s Long Clinical Laboratory Waits at Patient Service Centers Prompt Alberta Health Services to Add Extra Appointments, Temporary Locations

As patients and staff suffer with lengthening wait times, critics claim proposed solutions won’t remedy the ailing system of collecting medical laboratory specimens

With a backlog of lab appointments and a plethora of long wait times for phlebotomy services in the Canadian Province of Alberta, Alberta Health Services (AHS) is feeling the heat. As a result, Alberta Precision Laboratories is making efforts to improve services by adding 400 appointments in Calgary, CBC News reported.

The government-owned clinical laboratory lab company added these appointments at Peter Lougheed Centre and South Health Campus, both in Calgary, with 175 additional appointments coming down the line at the Foothills Medical Centre, also in Calgary, the CBC reported.

AHS is targeting “areas of high demand” and the efforts to bolster services include adding weekend appointments and “temporary new locations” the Calgary Herald reported.

The ripple effect from such delays in Canada’s public healthcare system are widespread and ruffling the feathers of patients, staff, and critics alike. Clinical laboratories in the United States may learn from watching how the Canadian health system resolves these issues.

“As of today, there were waits of upwards of 90 minutes for an appointment that’s already scheduled. That’s unacceptable,” Adriana LaGrange, Alberta’s Minister of Health, told CBC News. (Photo copyright: CBC News.)

Short- and Long-Term Efforts

Densely-populated Calgary and its surround areas have been experiencing increasingly long waits in the last few months. The Calgary Herald reported that their efforts to schedule a new lab appointment brought about only a handful of appointment times a few weeks out, with the majority of open times being five weeks out.

“I’ve heard some really distressing stories on how long it’s taken to get necessary lab work back,” Adriana LaGrange, Alberta’s Minister of Health, told CBC News. “This impedes the ability for physicians to make diagnoses, and we just can’t have that,” she added.

The 400 new appointments are “part of an arrangement worked out between Alberta Precision Labs and DynaLIFE, the private clinical laboratory provider that handles the bulk of community lab appointments in Alberta,” CBC News reported.

DynaLIFE, formerly Dynacare Kasper Medical Laboratories (DKML), is partly owned by Labcorp.

Alberta Precision Laboratories is “working on extending hours, hiring other third-party providers, and opening or expanding satellite centers [patient service centers] in and around Calgary to add 7,500 appointments per week, which would represent a 25% increase in the area,” LaGrange told CBC News.

“In the short term, we will provide the necessary appointments that are needed by Albertans, particularly in Calgary and the south area. In the long-term, we’ll work towards something where there’s more stability in the system,” she added.

Lengthy Waits to Receive Medical Laboratory Test Results

Patients and doctors in Calgary “say wait times for blood work and quality of services remain a concern under DynaLIFE Medical Labs who took operation over community labs last year,” the Calgary Herald reported.

“One Calgary doctor who asked to stay anonymous for fear of professional reprimand said she’s hearing from patients who have travelled out of the city to labs as far as Canmore or Didsbury to get testing done. She added her colleagues have complained about lengthy waits to receive lab results and said sometimes results aren’t sent at all or are directed to the wrong clinic,” the Calgary Herald reported.

At one DynaLIFE location, one patient waited two hours and 20 minutes for her previously-scheduled lab work even though online the wait time showed just 11 minutes, the Calgary Herald reported. “I don’t understand how anyone can get lab work done and work or look after their kids,” she said.

It is not clear why DynaLIFE is missing its published benchmarks.

AHS No Stranger to Controversy

Government health programs in many countries lack the necessary capital to train and employ adequate numbers of doctors, nurses, and other medical professionals, or to expand clinics/hospitals, clinical laboratories, or radiology services. Thus, demand generally exceeds supply and so government health systems ration care using wait times.

This is one factor in the Alberta story.

In Alberta, since the 1990s, various attempts by the AHS to expand clinical laboratory testing volumes/capabilities in advance of need have seesawed as liberal/conservative governments came and went—each with their own agenda on how healthcare should be organized.

Dark Daily’s sister publication The Dark Report covered that trend in “Alberta Health to Build New Lab to Serve Edmonton, Province.” We reported how following years of controversy associated with different plans to build a large new laboratory facility to serve Edmonton and the surrounding region, Alberta Health Services ended up financing and building the new lab with its own resources.

This was preceded by an announcement that the Alberta government would develop a new central laboratory to process 80% of the clinical laboratory tests in the Edmonton region and become the central lab for a new system from Alberta Health Services to process lab tests in the province.

At that time, Alberta had six different organizations providing clinical laboratory services. Having so many organizations involved in clinical laboratory testing services, according to then Alberta Health Minister Sarah Hoffman, resulted in a “needlessly complex and fragmented system.”

All of this explains why Calgary is experiencing wait times for phlebotomy that are frustrating patients. It’s a cautionary tale that clinical laboratory managers in this country may want to study.

—Kristin Althea O’Connor

Related Information:

Alberta Expands Medical Lab Test to Reduce Long Waits, Particularly in Calgary

Long Community Lab Wait Times Continue Under DynaLIFE for Calgary Patients

Alberta Health to Build New Lab to Serve Edmonton, Province

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