In a separate study, HHS finds a 40% increase in sepsis cases, as more patients succumb to infections without effective antibiotics and antimicrobial drugs
Given the drastic steps being taken to slow the spread of the Coronavirus in America, it’s easy to forget that significant numbers of patients die each year due to antibiotic-resistant bacteria (ARB), other forms of antimicrobial resistance (AMR), and in thousands of cases the sepsis that follows the infections.
The CDC’s website states that “more than 2.8 million antibiotic-resistant infections occur in the US each year, and more than 35,000 people die as a result.” And a CDC news release states, “on average, someone in the United States gets an antibiotic-resistant infection every 11 seconds and every 15 minutes someone dies.”
Those are huge numbers.
Clinical laboratory leaders and microbiologists have learned to be vigilant as it relates to dangerously infectious antimicrobial-resistant agents that can result in severe patient harm and death. Therefore, new threats identified in the CDC’s Antibiotic Resistance Threats in the United States report will be of interest.
Drug-resistant Microbes That Pose Severe Risk
The CDC has added the fungus Candida auris (C. auris) and carbapenem-resistant Acinetobacter (a bacteria that can survive for a long time on surfaces) to its list of “urgent threats” to public health, CDC said in the news release. These drug-resistant microbes are among 18 bacteria and fungi posing a greater threat to patients’ health than CDC previously estimated, Live Science reported.
In 2013, the CDC estimated that about two million people each year acquired an antibiotic-resistant (AR) infection that killed as many as 23,000. However, in 2019, the CDC reported that those numbers were low and that the number of deaths due to AR infections in 2013 was about twice that amount. During a news conference following the CDC announcement, Michael Craig (above), a Senior Adviser for the CDC’s Antibiotic Resistance Coordination and Strategy Unit said, “We knew and said [in 2013] that our estimate was conservative … and we were right,” Live Science reported. In 2019, CDC reported 2.8 million antibiotic-resistant infections annually with more than 35,000 related deaths in the US alone. (Photo copyright: Centers for Disease Control and Prevention.)
The CDC considers five threats to be urgent. Including the
latest additions, they are:
Dark Daily has regularly covered the healthcare industry’s ongoing struggle with deadly fungus and bacteria that are responsible for hospital-acquired infections (HAI) and sepsis. This latest CDC report suggests healthcare providers continue to struggle with antimicrobial-resistant agents.
Acinetobacter Threat Increases and C. auris
a New Threat since 2013
Carbapenem-resistant Acinetobacter, a bacterium that
causes pneumonia and bloodstream and urinary tract infections, escalated from
serious to urgent in 2013. About 8,500 infections and 700 deaths were noted by the
CDC in 2017.
C. auris, however, was not addressed in the 2013
report at all. “It’s a pathogen that we didn’t even know about when we wrote
our last report in 2013, and since then it’s circumvented the globe,” said Michael
Craig, Senior Adviser for the CDC’s Antibiotic Resistance Coordination and
Strategy Unit, during a news conference following the CDC announcement, Live
Science reported.
Today, C. auris is better understood. The fungus
resists emerging drugs, can result in severe infections, and can be transmitted
between patients, CDC noted.
By year-end, CDC tracking showed 988 cases in the US.
More Patients Getting Sepsis as Antibiotics Fail: HHS
Study
In a separate study published in Critical Care Medicine, a journal of the Society of Critical Care Medicine (SCCM), the US Department of Health and Human Services (HHS) found that antibiotic-resistant bacteria and fungi are resulting in more people acquiring sepsis, a life-threatening condition, according to an HHS news release.
Sepsis increased by 40% among hospitalized Medicare patients
from 2012 through 2018, HHS reported.
“These (untreatable infections) are happening here and now in the United States in large numbers. This is isn’t some developing world thing. This isn’t a threat for 2050. It’s a threat for here and now,” Cornelius “Neil” Clancy, MD, Associate Chief of Veterans Affairs Pittsburg Health System (VAPHS) and Opportunistic Pathogens, told STAT.
It is troubling to see data about so many patient deaths
related to antibiotic-resistant infections and sepsis cases when the world is
transfixed by the Coronavirus. Nevertheless, it’s important that medical laboratory
leaders and microbiologists keep track of how the US healthcare system is or is
not responding to these new infectious agents. And, to contact infection
control and environmental services colleagues to enhance surveillance, ensure
safe healthcare environments and equipment, and adopt appropriate strategies to
prevent antibiotic-resistant infections.
Scientist described the speed at which SARS-CoV-2’s full sequence of genetic material was made public as ‘unprecedented’ and medical labs are rushing to validate tests for this new disease
In the United States, headlines scream about the lack of
testing for the novel Coronavirus
disease 2019 (COVID-19). News reporters ask daily why it is taking so long
for the US healthcare system to begin testing large numbers of patients for
SARS-CoV-2, the virus that causes COVID-19. Yet, pathologists
and clinical
laboratory scientists know that new technologies for gene sequencing
and diagnostic testing are helping public health laboratories bring up tests
for a previously unknown new disease faster than at any time in the past.
At the center of the effort to develop accurate new assays
to detect SARS-CoV-2 and help diagnose cases of the COVID-19 disease are medical laboratory
scientists working in public health
laboratories, in academic medical centers, and in research labs across the
United States. Their collective efforts are producing results on a faster
timeline than in any previous discovery of a new infectious disease.
For example, during the severe
acute respiratory syndrome (SARS) outbreak in 2003, five months passed
between the first recognized case of the disease in China and when a team of
Canadian scientists cracked the genetic code of the virus, which was needed to
definitively diagnose SARS patients, ABC
News reported.
In contrast, Chinese scientists sequenced this year’s
coronavirus (originally named 2019-nCoV) and made it available on Jan. 10,
2020, just weeks after public health officials in Wuhan, China, reported the
first case of pneumonia from the unknown virus to the World Health Organization
(WHO), STAT
reported.
Increases in sequencing speed enabled biotechnology
companies to quickly create synthetic copies of the virus needed for research. Roughly
two weeks later, scientists completed sequencing nearly two dozen more samples
from different patients diagnosed with COVID-19.
Molecular biologist Kristian Andersen, PhD (above right, with graduate students who helped sequence the Zika virus), an Associate Professor in the Department of Immunology and Microbiology at Scripps Research in California and Director of Infectious Disease Genomics at Scripps’ Translational Research Institute, worked on the team that sequenced the Ebola genome during the 2014 outbreak. He told STAT that the pace of sequencing of the SARS-CoV-2 coronavirus is “unprecedented.” (Photo copyright: Scripps Research.)
Lower Sequencing Costs Speed COVID-19 Diagnostics Research
Additionally, a significant decline in the cost of genetic synthesis is playing an equally important role in helping scientists slow the spread of COVID-19.In its coverage of the SARS-CoV-2 outbreak, The Verge noted that two decades ago “it cost $10 to create a synthetic copy of one single nucleotide, the building block of genetic material. Now, it’s under 10 cents.” Since the coronavirus gene is about 30,000 nucleotides long, that price reduction is significant.
Faster sequencing and cheaper access to synthetic copies is
contributing to the development of diagnostic tests for COVID-19, an important
step in slowing the disease.
“This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified medical laboratories is a critical step forward in protecting the public health,” FDA Commissioner Stephen M. Hahn, MD, said in an FDA statement.
However, the Washington Post soon reported that the government-created coronavirus test kits contained a “faulty component,” which as of February 25 had limited testing in the US to only 426 people, not including passengers who returned to the US on evacuation flights. The Post noted that the nation’s public health laboratories took “the unusual step of appealing to the FDA for permission to develop and use their own [laboratory-developed] tests” for the coronavirus.
“This is an extraordinary request, but this is an extraordinary time,” Scott Becker,
Parallel efforts to develop and validate tests for COVID-19
are happening at the clinical laboratories of academic medical centers and in a
number of commercial laboratory companies. As these labs show their tests meet
FDA criteria, they become available for use by physicians and other healthcare
providers.
Dark Daily’s sister publication, The Dark Report just published an intelligence briefing about the urgent effort at the clinical laboratory of Northwell Health to develop both a manual COVID-19 assay and a test that can be run on the automated analyzers already in use in the labs at Northwell Health’s 23 hospitals. (See TDR, “Northwell Lab Team Validates COVID-19 Test on Fast Timeline,” March 9, 2020.)
Following the FDA’s March 13 EUA for the Thermo Fisher test,
Hahn said, “We have been engaging with test developers and encouraging them to
come to the FDA and work with us. Since the beginning of this outbreak, more
than 80 test developers have sought our assistance with development and
validation of tests they plan to bring through the Emergency Use Authorization
process. Additionally,” he continued, “more than 30 laboratories have notified
us they are testing or intend to begin testing soon under our new policy for
laboratory-developed tests for this emergency. The number of products in the
pipeline reflects the significant role diagnostics play in this outbreak and
the large number of organizations we are working with to bring tests to
market.”
Pharma Company Uses Sequencing Data to Develop Vaccine in
Record Time
Even as clinical laboratories work to develop and validate diagnostic tests for COVID-19, drug manufacturers are moving rapidly to develop a COVID-19 vaccine. In February, Massachusetts-based biotechnology company Moderna Therapeutics (NASDAQ:MRNA) announced it had shipped the first vials of its potential coronavirus vaccine (mRNA-1273) to the National Institute of Allergy and Infectious Disease (NIAID) for use in a Phase One clinical trial.
“The collaboration across Moderna, with NIAID, and with CEPI [Coalition for Epidemic Preparedness Innovations] has allowed us to deliver a clinical batch in 42 days from sequence identification,” Juan Andres, Chief Technical Operations and Quality Officer at Moderna, stated in a news release.
The Wall Street Journal (WSJ) reported that NIAID expects to start a clinical trial of about 20 to 25 healthy volunteers by the end of April, with results available as early as July or August.
“Going into a Phase One trial within three months of getting the sequence is unquestionably the world indoor record,” NIAID Director Anthony Fauci, MD, told the WSJ. “Nothing has ever gone that fast.”
There are no guarantees that Moderna’s coronavirus vaccine
will work. Furthermore, it will require further studies and regulatory
clearances that could delay widespread distribution until next year.
Nonetheless, Fauci told the WSJ, “The only way you
can completely suppress an emerging infectious disease is with a vaccine. If
you want to really get it quickly, you’re using technologies that are not as
time-honored as the standard, what I call antiquated, way of doing it.”
In many ways, the news media has overlooked all the important
differences in how fast useful diagnostic and therapeutic solutions for
COVID-19 are moving from research settings into clinical use, when compared to
early episodes of the emergence of a new infectious disease, such as SARS in
2003.
The story the American public has yet to learn is how new
genetic sequencing technologies, improved diagnostic methods, and enhanced
informatics capabilities are being used by researchers, pathologists, and
clinical laboratory professionals to understand this new disease and give
healthcare professionals the tools they need to diagnose, treat, and monitor
patients with COVID-19.
As CMS price transparency rules go into effect, and demand grows for publishing provider charges, consumers are becoming aware of how widely healthcare prices can vary
With the COVID-19 Coronavirus pandemic saturating the news, it is easy to forget that clinical laboratories regularly conduct medical tests for influenza, the common cold, and other illnesses, most of which are affordable and covered by health insurance. So, how did a common throat culture and blood draw result in a $25,865 bill?
That was the question a New York City woman asked after a
doctor’s visit for a sore throat that resulted in a five-figure charge. This
should not simply be dismissed as another example of hidden prices in clinical
laboratory testing or the true cost of medical procedures shocking a healthcare
consumer. The issue is far from new.
For example:
An Indiana girl’s snake bite at summer camp in 2019 resulted in a $142,938 bill, which included $67,957 for four vials of antivenin and $55,578 for air ambulance transport, reported Kaiser Health News (KHN);
In 2019, Dark Daily highlighted a New York Times article showing the insurer-negotiated price of a common blood test could range from $11 to $952 in different major cities;
In 2018, Dark Daily spotlighted a Kaiser Health News story about a $48,329 bill for outpatient allergy testing; and
In 2013, Dark Daily reported on a patient’s $4,317 bill for blood work done at a Napa Valley medical center, which a national lab would have performed for just $464.
Prices Vary Widely Even Within Local Healthcare Markets
As the push for price transparency in healthcare increases, exorbitant patient bills—often tied to providers’ chargemaster pricing—add to that momentum. Consumers now recognize that prices can vary widely for identical healthcare procedures, including clinical laboratory and anatomic pathology group tests and procedures.
However, on January 1, 2021, price transparency will get a major boost when the Centers for Medicare and Medicaid Services (CMS) final rule requiring hospitals to post payer-negotiated rates for 300 shoppable services goes into effect. Clinical laboratory managers and pathologists should be developing strategies to address this changing healthcare landscape.
Until price transparency is the norm, examples of outrageous pricing are likely to continue to make headlines. For example, National Public Radio’s (NPR) December 2019 “Bill of the Month,” titled, “For Her Head Cold, Insurer Coughed Up $25,865,” highlighted a recent example of healthcare sticker shock.
New York city resident Alexa Kasdan’s sore throat resulted in a $28,395.50 clinical laboratory bill (of which her insurer paid $25,865.24) for a “smorgasbord” of DNA tests aimed at explaining her weeklong cold symptoms. NPR identified the likely causes for the sky-high charges. In addition to ordering DNA testing to look for viruses and bacteria, Kasdan’s doctor sent her throat swab to an out-of-network lab, with prices averaging 20 times more than other medical laboratories in the same zip code. Furthermore, the lab doing the analysis, Manhattan Gastroenterology, has the same phone number and locations as her doctor’s office, NPR reported.
In contrast, NPR learned that LabCorp, Kasdan’s in-network laboratory provider, would have billed her Blue Cross and Blue Shield of Minnesota insurance plan about $653 for “all the ordered tests, or an equivalent.”
Ranit Mishori, MD, MHS, FAAFP (above), Professor of Family Medicine at the Georgetown University School of Medicine and Senior Medical Advisor for Physicians for Human Rights, maintains patients should not hesitate to question doctors about the medical tests they order for them. “It is okay to ask your doctor, ‘Why are you ordering these tests, and how are they going to help you come up with a treatment plan for me?’” Mishori told NPR. “I think it’s important for patients to be empowered and ask these questions, rather than be faced with unnecessary testing, unnecessary treatment and also, in this case, outrageous billing.” (Photo copyright: Primary Care Collaborative.)
Hospitals Can ‘Jack-up’ Prices
The Indiana girl’s snake bite at summer camp last year became another example of surprisingly high medical bills. Nine-year-old Oakley Yoder of Bloomington, Ind., was bitten on her toe at an Illinois summer camp. The total bill for treating the suspected copperhead bite was $142,938, which included $67,957 for four vials of antivenin and $55,578 for air ambulance transport, KHN reported.
The summary of charges her parents received from Ascension St. Vincent Evansville hospital included $16,989.25 for each vile of anti-venom drug CroFab, five times as high as the average list price for the drug. Until recently, KHN reported, CroFab was the only antivenom available to treat pit viper bites, which created a monopoly for the drug maker’s expensive-to-manufacture product. Though the average list price for CroFab is $3,198, KHN noted hospitals can “jack-up the price.”
While Yoder’s family had no out-of-pocket expenses thanks to a supplemental insurance policy through the summer camp, Yoder’s father, Joshua Perry, JD, MTS, Professor of Business Law and Ethics at Indiana University Kelley School of Business, knows his family’s outcome is unusual.
“I know that in this country, in this system, that is a
miracle,” he told KHN.
The push for healthcare price transparency is unlikely to
wane. Clinical laboratory leaders in hospitals and health networks, as well as
pathologists in independent clinical laboratories and anatomic pathology groups,
should plan for a future in which consumers demand the ability to see pricing
information before obtaining services, and regulations require it.
Physicians and clinical laboratories that do business with other healthcare providers who have been denied enrollment in Medicare or had their enrollment revoked are under increased scrutiny
Efforts by the Centers for Medicare and Medicaid Services
(CMS) to crack down on fraud could soon be bolstered by artificial
intelligence (AI) tools, placing new pressure on medical
laboratories and anatomic pathology groups to ensure that their billing
practices are fully compliant with current federal “affiliations” regulations.
This is why, last October, CMS issued a Request
for Information (RFI) seeking feedback from vendors, providers, and
suppliers about the potential use of AI tools to identify cases of fraud,
waste, and abuse in billing for healthcare services. Statements from CMS
indicate that the agency plans to deepen its investigation into the affiliations
physicians and clinical laboratories have with healthcare providers that been
involved in fraudulent behavior within the Medicare program.
At present, CMS uses a variety of approaches to spot
improper claims, the RFI notes, including the use of human medical reviewers.
However, this is a costly process that allows review of less than 1% of claims.
AI tools would increase the speed and accuracy of those investigations
exponentially.
The RFI notes that AI technology could “help CMS identify
potentially problematic affiliations upon initial screening and through continuous
monitoring. One example would be a new tool or technology that would allow
easy, seamless access to state and local business ownership and registration
information that could improve CMS’ line-of-sight to potentially problematic
business relationships.”
In a blog post on the federal agency’s website, CMS Administrator Seema Verma (above) wrote that “Advanced analytics and artificial intelligence can perform rapid analysis and comparison of large-scale claims data and medical records that could allow for more expeditious, seamless and accurate medical review, and ultimately, improved payment accuracy.” [Photo copyright: Centers for Medicare and Medicaid Services.)
CMS’ New Affiliations Rule Affects Clinical Laboratories
Our sister publication, The Dark Report (TDR),
provided in-depth coverage of this rule, which allows CMS “to revoke or deny
enrollment if it finds that a provider’s or supplier’s current or previous
affiliations pose an undue risk of fraud.” (See TDR, “Labs
Must Respond to New CMS Anti-Fraud Rule,” October 14, 2019.)
“For too many years, we have played an expensive and
inefficient game of ‘whack-a-mole’ with criminals—going after them one at a
time—as they steal from our programs,” CMS Administrator Seema Verma
said in a
statement about the new rule. “These fraudsters temporarily disappear into
complex, hard-to-track webs of criminal entities, and then re-emerge under
different corporate names. These criminals engage in the same behaviors again
and again.”
As TDR reported, the rule defines four “disclosable
events” that trigger the disclosure requirements:
Uncollected debt to Medicare, Medicaid, or CHIP;
Payment suspension under a federal healthcare program;
Exclusion by the Office of Inspector General from participation in Medicare, Medicaid, or CHIP; and
Termination, revocation, or denial of Medicare, Medicaid, or CHIP enrollment.
If disclosure is required, CMS described five definitions of
an affiliation, using a five-year look-back:
Direct or indirect ownership of 5% or more in another organization;
A general or limited partnership interest, regardless of the percentage;
An interest in which an individual or entity “exercises operational or managerial control over, or directly conducts” the daily operations of another organization, “either under direct contract or through some other arrangement;”
When an individual is acting as an officer or director of a corporation; and
Any reassignment relationship.
One interesting consequence of these definitions is that
individuals or companies that invest and own an interest in a provider
organization that has one or more “disclosable events” would be flagged by the
provider at time of enrollment or re-enrollment in the Medicare program. Over
the years, some very prominent private equity companies have been investors and
owners of medical laboratory companies that owed money to Medicare or entered
into civil settlements with the federal government where the full amount of the
alleged overpayments was not recovered and the provider neither admitted nor
denied guilt. These affiliations would need to be disclosed and could be used
by CMS to deny enrollment in the Medicare program.
“Lab companies that engage in fraud and abuse—often paying illegal inducements to physicians to encourage them to order medically-unnecessary tests—distort the lab testing marketplace and capture lab test referrals that would otherwise go to compliant clinical labs and pathology groups,” stated Robert Michel, Editor-In-Chief of The Dark Report. “So, honest labs will recognize how the new rule can help suppress various types of fraud that constantly plague the clinical lab industry.” (See TDR, “Is New Medicare Affiliation Rule Good, Bad, or Ugly?” November 4, 2019.)
Other AI Applications in Healthcare
The CMS RFI also suggests other areas in which artificial
intelligence could help identify fraudulent activity, including real-time monitoring
of electronic
health records (EHR), risk
adjustment data validation (RADV) audits, and value-based payment systems.
“These tools hold the promise of more expeditious, seamless
and accurate review of chart documentation during medical review to ensure that
we are paying for what we get and getting what we pay for,” the RFI states.
“However, concerns about potential improper payments and bad actors remain. We
need to determine whether innovative new strategies, tools, and technologies
presently exist that can increase data accuracy and integrity and consequently
reduce improper payments.”
Clinical laboratories should not be surprised by any of this.
Artificial intelligence and machine learning are increasingly becoming vital
tools in today’s modern healthcare system. Nevertheless, lab leaders should
closely monitor CMS’ use of these technologies to root out fraud, as labs are
often caught up in their investigations.
The menu of diagnostics, medications, and treatments available to us as healthcare providers is continually expanding. This creates more choices and decisions for the entire staff—from practitioners, to laboratory technicians, to IT personnel. Electronic health records (EHRs), originally intended to organize options and lighten information overload for both patient and provider, have evolved into sophisticated multi-featured tools, supported by entire departments and strongly impacting (if not actually driving) clinician workflows.
At the intersection of the EHR and provider choice lies clinical decision support (CDS). The benefits of clinical decision support are particularly important for clinical laboratories, given the lab’s central role in most diagnoses and treatments. By harnessing evidence-based guidelines to optimize test utilization, laboratories can reduce costs and strengthen care. Labs using evidence-based CDS are also better positioned to manage financial risk in a value-based environment.
To assist clinical laboratories in understanding the requirements and risks involved when implementing a CDS system, DARK Daily is pleased to offer this FREE White Paper—“Critical Factors for Launching a Clinical Decision Support System in the Hospital Laboratory”—the second publication of a three-part White Paper series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare.
Providing valuable industry perspective, commentary, and insights on the role of decision support in building an effective laboratory stewardship program, this White Paper series also highlights case-study proof points developed in collaboration with Mayo Clinic from early-adopter hospital laboratories—points that have successfully implemented third-party decision support to their value advantage.
Find these, and many more indispensable perspectives in this White Paper:
Gain insights into why the adoption of evidence-based clinical decision support has become increasingly essential to your laboratory’s success in today’s value-based environment
Understand the advantages of pursuing decision support solutions developed specifically for the clinical laboratory environment, and the challenges of developing your own CDS system from scratch
Looking for the right fit, and evaluating your lab’s requirements when researching a laboratory decision support system that’s the right fit for your organization
Choosing the laboratory decision support solution for your lab that demonstrates an infrastructure that will be effective and sustainable into the future
Learn why unless powerful analytics are developed to work in conjunction with your decision support system’s performance data, your platform’s value will be limited
White Paper Table of Contents
INTRODUCTION
Chapter 1: Understanding Clinical Laboratory Stewardship and Clinical Decision Support in the New Value-Based Environment
Chapter 2: Critical Factors for Determining Whether to Buy or Build Decision Support for the Hospital Laboratory
Chapter 3: Monitoring and Measuring Laboratory Test Utilization: The Ongoing Tasks Required of an Effective Clinical Decision Support Platform
CONCLUSION
This white paper—part 2 of a three-part series— provides practical pearls on how a proven decision support solution and one that is a good fit for your lab can be the foundation of an effective laboratory stewardship program, and can greatly assist in controlling utilization and meeting the challenges of value-based care. As well, the paper also clearly explains the points for “buy versus build” laboratory decision support.
Choosing the right decision support solution will empower your lab and hospital leaders, clinicians, and staff with more time to focus their core competencies on the provision of healthcare. Learn what you need to know by downloading your FREE copy of “Critical Factors for Launching a Clinical Decision Support System in the Hospital Laboratory” below.
Also available: the first publication in this three-part White Paper series, “Clinical Laboratories Under Pressure: Exploring Options to Re-establish Critical Relevancy and Maintain Independence.” Download it here.
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