The UE study sheds light on the types of bacteria in
wastewater that goes down hospital pipes to sewage treatment plants. The study
also revealed that not all infectious agents are killed after passing through
waste treatment plants. Some bacteria with antimicrobial (or antibiotic)
resistance survive to enter local food sources.
The scientists concluded that the amount of AMR genes found
in hospital wastewater was linked to patients’ length-of-stays and consumption
of antimicrobial resistant bacteria while in the hospital.
In a paper the University of Edinburgh published on medRxiv, the researchers wrote: “There was a higher abundance of antimicrobial-resistance genes in the hospital wastewater samples when compared to Seafield community sewage works … Sewage treatment does not completely eradicate antimicrobial-resistance genes and thus antimicrobial-resistance genes can enter the food chain through water and the use of [processed] sewage sludge in agriculture. As hospital wastewater contains inpatient bodily waste, we hypothesized that it could be used as a representation of inpatient community carriage of antimicrobial resistance and as such may be a useful surveillance tool.”
Additionally, they wrote, “Using metagenomics to identify
the full range of AMR genes in hospital wastewater could represent a useful
surveillance tool to monitor hospital AMR gene outflow and guide environmental
policy on AMR.”
Antimicrobial stewardship programs are becoming increasingly critical to preventing the spread of AMR bacteria. “By having those programs, [there are] documented cases of decreased antibiotic resistance within organisms causing these infections,” Paul Fey, PhD, of the University of Nebraska Medical Center, told MedPage Today. “This is another indicator of how all hospitals need to implement stewardship programs to have a good handle on decreasing antibiotic use.” [Photo copyright: University of Nebraska.]
Don’t Waste the Wastewater
Antibiotic resistance occurs when bacteria change in response to medications to prevent and treat bacterial infections, according to a World Health Organization (WHO) fact sheet. The CDC estimates that more than 23,000 people die annually from two million antibiotic-resistance infections.
Wastewater, the UE scientists suggest, should not go to
waste. It could be leveraged to improve hospitals’ detection of patients with antimicrobial
resistance, as well as to boost environment antimicrobial-resistance polices.
They used metagenomics (the study of genetic material
relative to environmental samples) to compare the antimicrobial-resistance
genes in hospital wastewater against wastewater from community sewage
points.
The UE researchers:
First collected samples over a 24-hour period from various areas in a tertiary hospital;
They then obtained community sewage samples from various locations around Seafield, Scotland;
Antimicrobial-resistance genes increased with longer length of patient stays, which “likely reflects transmission amongst hospital inpatients,” researchers noted.
Fey suggests that further research into using sequencing
technology to monitor patients is warranted.
“I think that monitoring each patient and sequencing their
bowel flora is more likely where we’ll be able to see if there’s a significant
carriage of antibiotic-resistant organisms,” Fey told MedPage Today. “In
five years or so, sequencing could become so cheap that we could monitor every
patient like that.”
Fey was not involved in the University of Edinburgh
research.
Given the rate at which AMR bacteria spreads, finding antibiotic-resistance
genes in hospital wastewater may not be all that surprising. Still, the University
of Edinburgh study could lead to cost-effective ways to test the genes of
bacteria, which then could enable researchers to explore different sources of
infection and determine how bacteria move through the environment.
And, perhaps most important, the study suggests clinical
laboratories have many opportunities to help eliminate infections and slow
antibiotic resistance. Microbiologists can help move their organizations forward
too, along with infection control colleagues.
Metabolic panels of 14 blood-based biomarkers that can predict when a patient is likely to die may be coming to a medical laboratory near you
Clinical pathologists soon may be able to predict when patients will die, thanks to a recent study that reveals new insights into how the human body works. Researchers at the Max Planck Institute for Biology of Ageing in Germany and the Leiden University Medical Center (LUMC) in the Netherlands revealed a metabolic panel of biomarkers that can more accurately predict death within five to 10 years than standard measures.
The researchers’ original goal was to find blood-based
biomarkers that could show whether a person was vulnerable to death,
particularly if that vulnerability was related to modifiable lifestyle factors.
The researchers published their study, titled, “A Metabolic Profile of All-Cause Mortality Risk Identified in an Observational Study of 44,168 Individuals,” in the journal Nature Communications last August.
Metabolic Biomarkers More Accurate than Current Health
Measures
During their investigation, the researchers looked at 12
cohorts from previous studies and examined the results of 44,168 individuals
between the ages of 18 and 109. In the follow-up to the study, 5,512 of the
participants died.
In the introduction to their published study the researchers
wrote, “We first determine which metabolic biomarkers independently associate
with prospective mortality in all individuals. Subsequently, we test the
association of the biomarkers with mortality in different age strata.”
The researchers then used the 14 biomarkers they identified to
create a score that predicts mortality within five to 10 years.
The measures that most providers currently use to determine an elderly person’s overall health generally include blood pressure, heart rate, and functionality measures such as grip strength and gait. However, P. Eline Slagboom, PhD, LUMC Professor of Molecular Epidemiology and the study’s director, told The Scientist that those metrics are not always accurate methods for measuring health.
“For example, a somewhat higher weight, blood pressure, or
cholesterol level is not as bad for individuals over 80 years of age as
compared to younger individuals,” she said.
As it turned out, the traditional measures were
significantly less accurate than the score Slagboom and her team developed.
Traditional measures were accurate about 78% of the time, while the metabolic
panel was accurate about 83% of the time, reported The Scientist.
Additionally, the score based on metabolic biomarkers was accurate for people
of all ages, rather than only among the young.
“As researchers on aging, we are keen to determine the biological age. The calendar age just doesn’t say very much about the general state of health of elderly people: one 70-year old is healthy, while another may already be suffering from three diseases. We now have a set of biomarkers which may help to identify vulnerable elderly people,” said P. Eline Slagboom, PhD (above), LUMC Professor of Molecular Epidemiology and the study’s director, in a statement. (Photo copyright: Max Planck Institute for Biology of Ageing.)
Study Yields Strong but Surprising Results
Researchers have studied biomarkers as predictive tools for quite some time, with only narrow success. The positive results of the Max Planck Institute/LUMC study even surprised those who worked on it. “We were surprised that the association of our biomarker score with mortality was so strong, given that it is only based on 14 metabolic markers in the blood measured at a single point in the life of individuals,” the study’s lead author Joris Deelen, PhD, a postdoctoral researcher at the Max Planck Institute for Biology of Ageing, said in The Scientist.
But though the results of the study are intriguing, some
experts remain skeptical that a new biomarker for death has been found.
In reactions published by the Science Media Centre, an independent organization in the UK that promotes “the reporting of evidence-based science,” Kevin McConway, PhD, Emeritus Professor of Applied Statistics at The Open University wrote, “This is a solid and interesting piece of research. But it doesn’t go beyond investigating the plausibility of setting up a system for predicting risk of death, based on this type of data. It doesn’t claim to do more than that, and makes clear that there’s some way to go, in terms of research and analysis, until a risk prediction tool that’s useable in clinical work with patients might emerge.”
And in the same article, Amanda Heslegrave, PhD, a post-doctoral research associate and researcher at the UK Dementia Research Institute at the University College London wrote, “Whilst this study shows that this type of profiling can be useful, [the researchers] do point out importantly that it would need further work to develop a score at the individual level that would be useful in real life situations. We’d need to see: validation to ensure repeatability in different labs, production of reference samples to test this on an ongoing basis, work to make the individual score possible, validation in other cohorts and validation of all components of the panel. So, it’s an exciting step, but it’s not ready yet.”
Past Mortality Biomarker Studies
Other investigations into the use of biomarkers as a predictive tool have focused more narrowly on specific causes of death. For example, in 2008, the New England Journal of Medicine (NEJM) published a study titled, “Use of Multiple Biomarkers to Improve the Prediction of Death from Cardiovascular Causes.” The study concluded that using biomarkers and risk factors together “substantially improves the risk stratification for death from cardiovascular causes.”
Another study, from 2017, examined stress biomarkers, hospital readmission, and death. Published in the Journal of Hospital Medicine titled, “Association of Stress Biomarkers with 30-Day Unplanned Readmission and Death,” the researchers found that “stress biomarkers improved the performance of prediction models and therefore could help better identify high-risk patients.”
Other studies have examined the predictive possibilities of
biomarkers in:
Even with all of the research into biomarkers, scientists are still a long way from having a clinical tool to predict death. However, according to Leo Cheng, PhD, Associate Biophysicist, Pathology and Radiology at Massachusetts General Hospital, and Associate Professor of Radiology at Harvard Medical School, the Max Planck study is on the right path.
The Scientist states that though Cheng believes the
study doesn’t “prove anything,” he also notes that “using a score that combines
the information from all 14 biomarkers is ‘the correct thing [to do]’ to
provide a holistic look at metabolic pathways that may represent a person’s
health.”
So, it might be awhile before clinical laboratories will be
processing metabolic panels that return test results predicting a patient’s
mortality within 10-15 years. Nevertheless, how medical labs would be involved
in such testing is certainly something to think about.
Clinical laboratory leaders interested in positioning their labs to be paid for added-value services will get knowledge, insights, and more at upcoming third annual Clinical Lab 2.0 Workshop in November
It’s a critical time for medical laboratories. Healthcare is transitioning from a fee-for-service payment system to new value-based payment models, creating disruption and instability in the clinical lab test market. In addition, payers are cutting reimbursement for many lab tests.
These are among the market factors leading some pathologists
and clinical lab leaders to seek new or alternative sources of revenue to keep
the lights on and the machines running in their laboratories. Some might say,
it’s a dark time for the lab industry.
“This is not the time to be shy or timid,” he declared. “The
quantitative value of medical laboratory domain is significant and will be lost
if not exploited or leveraged.”
Shotorbani has reason to be positive. In recent years the Project Santa Fe Foundation (PSFF) has emerged to advocate for, and teach, the Clinical Lab 2.0 model. Clinical Lab 2.0 is an approach which focuses on longitudinal clinical laboratory data to augment population health in new payment arrangements.
Earlier this year, PSFF filed for 501(c) status, according to a news release. It is now positioned as a nonprofit organization, guided by a board of directors whose mission is “to create a disruptive value paradigm and alternative payment model that defines placement of diagnostic services in healthcare.”
Progressing Toward Clinical Lab 2.0
At the 24th Annual Executive War College on Lab and Pathology Management held in New Orleans last May, the nation’s first ever Clinical Lab 2.0 “Shark Tank” competition was won by Aspenti Health, a full-service diagnostic laboratory specializing in toxicology screening.
“This project, as well as all of the other cases that were presented, were quite strong and all were aligned with the mission of the Clinical Lab 2.0 movement,” said Shotorbani, in a news release. “This movement transforms the analytic results from a laboratory into actionable intelligence at the patient visit in partnership with front-liners and clinicians—allowing for identification of patient risks—and arming providers with insights to guide therapeutic interventions.
“Further, it reduces the administrative burden on providers by collecting SDH [social determinants of health] predictors in advance and tying them to outcomes of interest,” he continued. “By bringing SDH predictors to the office visit, it enables providers to engage in SDH without relying on their own data collection—a current care gap in many practices. The lab becomes a catalyst helping to manage the population we serve.”
Aspenti Health’s Shark Tank entry, “Integration of the Clinical Laboratory and Social Determinants of Health in the Management of Substance Use,” focused on the social factors tied to the co-use of opioids and benzodiazepines, a combination that puts patients at higher risk of drug-related overdose or death.
The project revealed that the top-two predictors of co-use
were the prescribing provider practice and the patient’s age.
“They did an interesting thing—what clinical laboratories
alone cannot do—the predictive value of lab test data mapped by zip code for
patients admitted in partnership with social determinants of health. This helps
to create delivery models to potentially help prevent opioid overdose,” said
Shotorbani, who sees economic implications for chronic conditions.
“If clinical laboratories have that ability to do that in
acute conditions such as opioid overdose, what is our opportunity to use lab test
data in chronic conditions, such as diabetes? The cost of healthcare is in
chronic conditions, and that is where clinical lab data has an essential role—to
support early detection and early prevention,” he added.
“This is often described as the transition from volume to value because this trend will fundamentally change how all clinical laboratories and anatomic pathology groups are paid,” said Khosrow Shotorbani (above), MBA, MT(ASCP), Executive Director of the Project Santa Fe Foundation (PSFF), during his presentation at the 22nd annual Executive War College in New Orleans. “This shift from volume to value also will create new winners and losers in the clinical lab industry,” he declared. “Not every lab organization will take the timely action required to introduce the value-based laboratory testing services that hospitals, physicians, and payers will need. (Photo copyright: Albuquerque Business First.)
Clinical Laboratory Data is Health Business Data
One clinical laboratory working toward that opportunity is TriCore Reference Laboratories in Albuquerque, N.M. It recently launched Diagnostic Optimization with the goal of improving the health of their communities.
“TriCore turned to this business model,” Shotorbani
explained. “It is actively pursuing the strategy of intervention, prevention,
and cost avoidance. TriCore is in conversation with health plans on how its lab
test data and other data sets can be combined and analyzed to risk-stratify a
population and to identify care gaps and assist in closing gaps.
“Further, TriCore is identifying high-risk patients early
before they are admitted to hospitals and ERs—the whole notion of facilitating
intervention between the healthcare provider and the potential person who may
get sick,” he added. “These are no longer theoretical goals. They are
realizations. Now the challenge is for Project Santa Fe to help other lab
organizations develop similar value-added collaborations in their communities.”
Renee Ennis, TriCore’s Chief Financial Officer, told American Healthcare Leader, “Women go in (to an ER) for some condition, and the lab finds out they are pregnant before anyone else,” she said, adding that TriCore reaches out to insurers who can offer care coordinators for prenatal services.
“There is definitely a movement within the industry in this
direction [of Clinical Lab 2.0],” she added. “But others might not be moving as
quickly as we are. As a leader in this transition, I think a lot of eyes are on
what we are doing and how we are doing it.”
Why Don’t More Lab Leaders Move Their Labs to Clinical
Lab 2.0?
So, what holds labs back from pursing Clinical Lab 2.0?
Shotorbani pointed to a couple of possibilities:
A lab’s traditional focus on volume while not
developing partnerships (such as with pharmacy colleagues) inside the
organization; and
Limited longitudinal data due to a provider’s
sale of lab outreach services or outsourcing the lab.
“The whole notion of Clinical Lab 2.0 is basically connecting the longitudinal data—the Holy Grail of lab medicine. That is the business model. Without the longitudinal view, the ability to become a Clinical Lab 2.0 is extremely limited,” added Shotorbani.
New Clinical Lab 2.0 Workshop Focuses on Critical ‘Pillars’
Project Santa Fe Foundation will host the Third Annual Clinical Lab. 2.0 Workshop in Chicago on November 3-5. New this year are sessions aligned with Clinical Lab 2.0 “pillars” of leadership, standards, and evidence. The conference will feature panels addressing:
C-suite Drivers: moderated by Mark Dixon, President of The Mark Dixon Group;
Drug companies claim HHS rule violates their first amendment rights, but added web links to drug prices in their TV ads anyway
Will American consumers ever see the prices of their
prescription drugs? That almost happened this summer, when a Trump
administration healthcare transparency initiative would have required
pharmaceutical companies to include prices in drug advertisements. But that
requirement was halted by a federal judge one day before it was scheduled to take
effect.
The measure, which passed in May, was intended to provide
healthcare consumers with price transparency for some prescription medications
and help lower prescription costs. However, a federal judge placed the new law
on hold citing government over-reach.
This is a significant development for clinical
laboratory managers, pathologists,
and others watching efforts that will enable patients to see the cost of their
medical care in advance of service. Also, few were surprised to learn that this
court case was filed by pharmaceutical companies with the goal of preventing
prescription drug prices from being disclosed in these advertisements.
HHS Tells Big Pharma to ‘Level with People’ About Drug
Costs
Reducing prescription drug prices is a critical issue for
healthcare consumers. Therefore, any policy that helps lower costs should
provide benefits for both patients as well as the healthcare industry overall.
That’s why President Trump signed the initiative that required pharmaceutical
companies to include drug prices in television advertisements.
“We are telling drug companies today: You’ve got to level with people [about] what your drugs cost,” Health and Human Services (HHS) Secretary Alex Azar (above) stated after Congress passed the President’s proposal, STATreported. “Put it in the TV ads. Patients have a right to know, and if you’re ashamed of your drug prices, change your drug prices. It’s that simple.” [Photo copyright: Washington Times.]
The controversial proposal, which would have applied to all prescription
drugs that cost more than $35 for a one-month supply, was scheduled to go into
effect over the summer until it was blocked by Federal Judge Amit Mehta of
the US District Court for the District of Columbia.
Judge Mehta ruled that HHS does not have the regulatory
power to force pharmaceutical companies to include the prices of prescription
drugs in their TV ads and that the agency had violated laws passed by Congress.
“That policy very well could be an effective tool in halting
the rising cost of prescription drugs. But no matter how vexing the problem of
spiraling drug costs may be, HHS cannot do more than what Congress has
authorized,” Mehta wrote in his decision, NPR
reported.
Drug companies Amgen
(NASDAQ:AMGN), Eli Lilly (NYSE:LLY) and Merck (NYSE:MRK) along with the Association of National Advertisers (ANA) filed
lawsuits over the regulation stating it was a violation of their free speech
rights. They won the reprieve on July 8, just one day before the regulation would
have gone into effect.
Mehta stated in his opinion
that the Social
Security Act, which HHS used as its basis for the regulation, does not
“empower HHS to issue a rule that compels drug manufacturers to disclose list
prices,” Fierce
Pharma reported.
In August, the Trump administration filed an appeal after the
federal judge struck down the regulation. The exact basis for that appeal has
not been disclosed.
Drug Companies Decry New Law as Unconstitutional
Many drug makers are not happy with the rule. Drug industry
trade group Pharmaceutical Research and
Manufacturers of America (PhRMA) believes that mandating drug companies to
disclose pricing in TV commercials is a violation of their First Amendment
rights, STAT reported.
Nevertheless, PhRMA proposed that pharmaceutical companies
provide a web link in their TV advertisements that directs consumers to pricing
information online. And some companies also are experimenting with going a step
further and voluntarily complying with the original regulation.
In a news
release, PhRMA states, “To help patients make more informed healthcare
decisions, [PhRMA] member companies today announced their commitment to
providing more transparency about medicine costs. PhRMA member companies’
direct-to-consumer (DTC) television advertisements will soon direct patients to
information about medicine costs, including the list price of the medicine,
out-of-pocket costs, or other context about the potential cost of the medicine
and available financial assistance. The biopharmaceutical industry will also
launch a new platform that will provide patients, caregivers, and providers
with cost and financial assistance information for brand-name medicines, as
well as other patient support resources.”
However, Azar said that action is not in compliance with the
rule. “They put $4 billion a year into television advertising because the
television ad is where people are getting their information, and to point them
to the internet would be the equivalent of saying that they should simply be
putting their ads on the internet and not running them on TV,” he told the
press, STAT reported.
Opponents of the rule noted that actual drug costs for
consumers can vary widely depending on coverage and that patients might forgo
their medications if they are concerned about the costs, reported Politico
following passage of the measure in May.
Critics also claimed that that there were no enforcement
mechanisms outlined for companies that did not comply with the ruling, and that
it relied on the pharmaceutical industry to police itself. If a particular
company failed to include the required information in its TV ads, competitors
could file suit against it under the deceptive and unfair trade practice
provisions of the Lanham Act,
Politico noted.
Solutions to the public’s demand for price transparency in
healthcare may be forthcoming. However, at press time, no further information
concerning the status of this HHS regulation was available. Dark Daily
will continue to monitor the situation and inform readers of any developments.
Meanwhile executives and pathologists at the nation’s
clinical laboratories should continue to develop strategies to serve patients
who want to know the prices of their medical laboratory tests before they arrive
to have their specimens collected.
This summer, several pharma companies may have succeeded in
getting a federal court to stop this particular rule to disclose prescription
drug prices. But the trend toward price transparency has deep roots and will
continue forward.
Another push for price transparency steps up pressure on medical laboratories and anatomic pathology groups to develop compliance strategies
Clinical
laboratories and anatomic
pathology groups are under increasing pressure to develop strategies for
making their test prices more accessible to patients. Those pressures are
likely to grow due to newly proposed federal regulations that aim to allow
patients to compare prices for healthcare services on their smartphones.
This new proposed rule comes less than a year after a rule
involving hospital prices was implemented. As of January 1, 2019, the federal
Centers for Medicare and Medicaid Services (CMS) required
US hospitals to post their prices online. Dark
Daily reported last year about the risks and opportunities posed by
that move.
“In our current health system, there is an asymmetry of information for patients. They have few ways if any to anticipate or plan for costs, lower or compare costs, and, importantly, measure their quality of care or coverage relative to the price they pay. Transparency in the price and cost of healthcare could help address some of those concerns by empowering patients with information they need to make informed decisions,” said Donald Rucker, MD (above), National Coordinator for Health Information Technology (ONC), in remarks delivered to the US Senate. (Photo copyright: ONC.)
Giving Patients Access to Their Health Information
In May, officials with those agencies discussed the
regulations in prepared remarks for a hearing of the HELP committee.
“A central purpose of the proposed [ONC] rule is to
facilitate patient access to their EHI on their smartphone, growing a nascent
patient- and provider-facing app economy,” he said, noting that this access is
impeded by a lack of interoperability between health information systems, as
well as restrictions on information exchange imposed by health IT developers.
The proposed rule will mandate use of common software
standards so that app developers can access health information systems from
different vendors. As a result, patients could choose their own apps to view
their data regardless of which electronic
health records (EHR) system their provider uses. The rule also includes
provisions for dealing with so-called “information blocking”
by vendors, Rucker noted.
If the proposed rule is implemented as currently written,
there would be a need for clinical laboratories and pathology groups to ensure
that their laboratory
information systems (LIS) meet the specifications of the new rule. This may
mean that, along with enabling two-way digital interfaces with physicians’
EHRs, labs also would need to be able to pass data to the apps and mobile
devices used by patients that are covered by the proposed new rule.
“ONC’s proposed rule primarily focuses on clinical data,” he
said. “However, advances in computer science and the maturity of data standards
are accelerating the convergence of medical data with billing and price data.
As such, the rule proposes to include such information as part of a patient’s
EHI that should be available for access, exchange, and use.”
Enabling cost comparisons will allow patients to make
more-informed decisions about their healthcare, Rucker added. But he
acknowledged that implementing this vision won’t be easy.
“Unfortunately, the complex and decentralized nature of how
payment information for healthcare services is currently created, structured,
and stored presents many challenges to achieving price transparency,” he said.
“This entire information chain is geared to retrospective payments rather than
prices.”
Rucker told the HELP committee that the [ONC] will be
seeking public input about how to capture price information and enable price
transparency. Once the rule is finalized and published, providers will have two
years to comply.
Medical Laboratories Need a Strategy for Providing Access
to Patient Records
The proposed CMS rule imposes requirements on payers to
provide electronic access to health claims and other information for their
enrollees.
In her prepared remarks
for the Senate HELP hearing, Kate Goodrich,
MD, Director of the Center for Clinical Standards and Quality (CCSQ) and
CMS Chief Medical Officer, said, “A core policy principle underlying our
proposals is that every American should be able, without special effort or
advanced technical skills, to see, obtain, and use all electronically available
information that is relevant to their health, care, and choices—of plans,
providers, and specific treatment options.”
That’s all well and good, however, as Fred Schulte, a senior
correspondent for Kaiser
Health News, wrote in his coverage of the two proposed rules, “Meeting
these goals could prove to be a tall order.”
He continued, “For well over a decade, federal officials
have struggled to set up a digital records network capable of widespread
sharing of medical data and patient records.” Not to mention the billions of
dollars already spent by the CMS and ONC incentivizing providers to implement
truly interoperable health
information exchange (HIE) systems nationwide.
Nevertheless, pressure for greater consumer data access and
price transparency will likely continue to build across the healthcare
industry, including on medical laboratories. Price transparency as a trend is
making steady forward progress, despite resistance by hospitals, physicians,
medical associations, and others.
All clinical laboratories should have a strategy to make lab
test prices readily available to patients. It is something that will become
common at some future point.
