Recently enacted EKRA law prohibits payment activities that were legal under the previous Anti-Kickback Statute, confusing clinical laboratories and legal experts alike
There is a relatively new law on the books that impacts clinical
laboratories, and lab leaders tasked with ensuring compliance with federal
statutes need to fully understand it because getting it wrong could have dire
consequences.
“It prohibits any kickback or payment or solicitation of a
kickback in exchange for referring patients to clinical laboratories,” Danielle
Holley, a health law attorney and shareholder at O’Connell and Aronowitz in Albany, N.Y., told
the Dark
Daily.
Thus, it is critical that clinical laboratories understand
their requirements under EKRA. Misunderstandings could bring “criminal
penalties” which would seriously threaten lab managers and stakeholders.
What Must Labs Do to
Comply with EKRA?
Under EKRA, legal experts advise clinical laboratories to no
longer pay sales staff on a commission basis.
“Labs are no longer safe by following past advice. They have
to rethink payment to sales and marketing personnel,” Holley noted. She
explained that labs can no longer pay commissions that vary by:
Number of people referred to the lab;
Number of lab tests performed; or,
Percentage of payment sent to the lab.
EKRA also applies to commercial payers, whereas the federal Anti-Kickback
Statute did not, she added.
“Many labs are not coming to grips with what this means to
them,” Jeffrey
Sherrin, President of O’Connell and Aronowitz, told Dark Daily.
Clinical Laboratories
Not Clear on EKRA and Its Implications
EKRA is an all-payer statue that prohibits medical laboratories,
clinical treatment facilities, and recovery homes from soliciting payments for
referrals, the National Law Review pointed out.
That seems clear enough, but it’s anything but to many legal
experts and medical lab industry leaders who are unsure whether EKRA actually
applies to clinical labs. It’s possible, some experts claim, that it applies only
to toxicology labs, which would make sense given the SUPPORT Act’s original context.
“There is an open issue about whether the description of paying
employees applies to toxicology labs or all labs. Even though the focus of this
law is toxicology and relationship of labs, sober homes, and
treatment centers, the language of the statute seems to cover all clinical
laboratories—not just toxicology,” Sherrin said.
“If you want to be safe, you pay on straight salary. The
problem is, that does not give an incentive to the salesperson to go out and
beat the bushes and hustle to bring in new business (to the lab),” he added.
The SUPPORT Act and EKRA could negatively affect clinical
laboratory business should sales and marketing employees choose to work for
durable medical equipment companies or other industries that pay them on
commission, Sherrin pointed out.
“Some [sales professionals] may find the lab is not
lucrative enough. The lab could offer higher salaries, but then the risk is on
the lab without assurance business is coming in. These are difficult business
decisions,” Sherrin said.
ACLA Seeks Clarity on
EKRA and Clinical Labs
The American Clinical
Laboratory Association (ACLA) wants clarity on the issue as well. Sharon West, ACLA’s
Vice President, Legal and Regulatory Affairs, told The Dark Report, Dark Daily’s sister publication, “We are
seeking clarity as best we can from the administration and from Congress. But
it’s just not here yet.”
In a
letter to the US Department of Health and Human Services Office of Inspector
General (OIG), West wrote, “The legislation adds a new section … that would
authorize the imposition of criminal penalties for some conduct that currently
is permissible under Anti-Kickback Statute safe harbors. As written, section
8122 (EKRA) of the legislation applies to all laboratories, not merely
laboratories that perform testing for recovery homes and clinical treatment
facilities, and to all services covered by all payers, rather than only items
and services covered by the federal healthcare programs.”
Increased Scrutiny of
Clinical Laboratories
Barring an act of Congress, it could take a prosecution to
ultimately define the issue of whether authorities intended all labs to be
covered by EKRA or not, Sherrin said.
“Clinical laboratories need to understand that the
environment in which testing is occurring—in particular toxicology testing—is
rapidly changing and increasingly sensitive. And, it’s going to be under
increasing scrutiny. So, practices that may have passed muster in the past are
probably history. Now, this is front-page importance,” Sherrin declared.
Key takeaways Sherrin and Holley will provide to EWC
attendees include:
Understanding what EKRA is and its impact on
clinical labs;
Acknowledging the importance of reviewing
payment arrangements to bring labs into compliance;
Addressing EKRA as an all-payer statute that applies
to commercial payers as well as federal healthcare programs.
Conducting a risk-assessment of your medical
lab’s sales compensation program for compliance with EKRA and the federal
Anti-Kickback Statute.
Their presentation at the Executive War College (EWC) takes place from 1:45 pm to 2:35 pm, April
30, at the Sheraton Hotel in New Orleans.
To learn more about this and other critical topics affecting
clinical laboratories, register to attend EWC presentations by clicking here, or by placing
this URL into your Internet browser (https://www.executivewarcollege.com/register/).
Reserve your space today by visiting online or by calling 707/829-8495.
Prior (2018) price reporting cycle offers lessons that can help clinical laboratory benefit administrators and personnel take an informed approach to meeting the requirements of the Protecting Access to Medicare Act of 2014 (PAMA)
With the PAMA Private Payor Price Reporting period under way, some clinical laboratories may be grappling with questions about the new requirements.
Under PAMA, applicable labs must report private payer data on
selected Clinical Diagnostic Laboratory Tests (CDLTs) to CMS every three years. For the current
cycle, data must be collected from Jan. 1 through June 30.
A six-month review period follows so that laboratories can
assess whether the applicable lab thresholds are met. Data must be reported to
the Centers for Medicare & Medicaid Services (CMS) during a three-month
window starting Jan. 1, 2020, with data due by March 31, 2020.
To help clinical laboratories
meet PAMA’s new requirements, CMS defines an applicable laboratory as one that answers
yes to the following questions:
1) Does the lab
have CLIA certification?
2) Does the lab
meet the majority of Medicare threshold, which is either greater than 50
percent of Medicare payments received on CLFS and PFS (Physician Fee Schedule)
by National Provider Identifier (NPI) or a hospital lab with a shared NPI bills
any Type of Bill (TOB) 14x to Medicare during the six-month reporting timeframe.
3) Does the lab
have a minimum of $12,500 payments received from Medicare during the six-month
reporting period.
Failure to file, or filing late, incomplete, or
inaccurate data can result in federal fines for laboratories—up to
$10,000 a day.
Sarah Simonson, Director of Laboratory Client Management for Change Healthcare, outlines ways labs can avoid those fines and best prepare for this cycle of private payer reporting.
“Begin with the end in mind,” Simonson said. “Understand what is required and prepare for data extraction.” Simonson is one of several pros who will offer insights during a special post-Executive War College workshop geared to private payer price data reporting under PAMA.
Labs should allow
ample time to review extracted data, Simonson said, as well as evaluate the
data for quality assurance. It’s also important to understand login
requirements and the format required to deliver the data. That
means getting your IT team involved.
Trish Hankila, Chief Financial Officer of South Bend Medical Foundation, will return to the Executive War College on Lab and Pathology Management, for a special post-conference workshop on the PAMA price reporting requirement. (Photo copyright: Dark Daily)
Having learned many lessons from the previous reporting cycle, Trish Hankila, Chief Financial Officer of the South Bend Medical Foundation, recommends talking with your internal IT or vendor to ensure that accounts receivable (A/R) reports capture the required data. Review available data to ensure accuracy and completeness of data, and review the A/R report that will be used to transmit that data, she says.
Hankila, who will also speak at the 24th Annual Executive War College post-conference workshop encourages a visit to the CMS website to obtain documents regarding the data, registration, and submission requirements.
“The Center for
Medicare Management, CLFS User Manual explains in detail how to log in to the
CMS portal, register the data submitter and data certifier, and the process for
submitting and certifying the data,” Hankila said.
CMS will use the
data collected to calculate 2021 fees for each individual laboratory Current
Procedural Terminology (CPT) code.
“CMS is trying to establish fees
that reflect the market value of the tests being performed, using a weighted
average of the various amounts paid per CPT code by third-party payers,”
Hankila said.
How to structure your
data when working with your internal IT team or third-party billing will be one
focus of the PAMA workshop, in addition to how to avoid the pitfalls when
gathering, analyzing, and reporting lab test price data. The post-conference workshop will
benefit administrators and personnel responsible for reporting PAMA data.
“What Hospital and
Health Network Labs Must Know to Comply with PAMA Private Payer Price
Reporting,” will take place from 8 a.m. to 5 p.m., May 2, in New Orleans.
“The takeaways include
understanding PAMA, lessons learned from the prior (2018) cycle, and how to
structure your request to your IT/billing department,” Simonson said.
To help attendees prepare to
participate in the PAMA workshop, Hankila previewed what South Bend Medical
Foundation has learned:
Get
started early with data gathering and the reconciliation process;
Reconcile
the data by using other reports from your A/R system;
Ensure
you have enough time to modify programs; and
Do
not wait until the last minute to transmit the data.
“There may be issues with
registration of the submitter and certifier in the CMS portal, the CMS website,
or with your data file that you have prepared for submission,” Hankila said.
More Upcoming PAMA Workshop
Highlights
Elizabeth Sullivan, JD, will cover “Compliance and Regulatory Issues Associated with the PAMA Statute and the CMS Final Rule for Reporting Private Payer Lab Test Prices: Risks, Consequences, and Often-Overlooked Requirements.”
Diana Voorhees, MA, CLS, MT, SH, CLCP, CPCO, will cover “Understanding the Requirements for Reporting PAMA Private Payer Lab Test Price Data: Who Reports, What Is Reported, How to Report, When Penalties Apply, and More.”
Kyle C. Fetter, MBA, BA, will present “Key Recommendations for Reporting Your Lab’s Private Payer Price Data: Identifying Data Sources, Using Informatics Tools, Understanding Where Data is Missing or Inaccurate, and Transmitting Your Data.”
Massive government takeover of healthcare would create single-payer healthcare system, doing away with Medicare Advantage and individual choice
All clinical laboratories and anatomic pathology groups have a strong interest in how any reform of US healthcare at the federal level might be accomplished. In that spirit, Dark Daily is providing a quick overview of the Medicare for All Act of 2019 (HR 1384). The name is misleading. The bill would actually end Medicare and all private health insurance in America.
This element of the proposed bill has not gotten much attention in national media coverage. If Congress did pass the bill as proposed by newly elected US Rep. Pramila Jayapal (D-Wash.), it would eliminate all existing private health plans, as well as the existing Medicare program! That includes Medicare Advantage, which serves 20 million seniors. HR 1384 would replace all of these health programs with a national service-on-demand government-funded system.
Though it’s unlikely to advance through Congress, the fact
that this massive federal program is even being considered reflects the
thinking certain Congressional representatives have about single-payer health
systems.
According to the Seattle Times, the proposed “Medicare for All” program would pay for:
Primary care;
Prescription drugs;
Dental and eye care;
Long-term care;
Reproductive health; and,
Mental-health and substance-abuse treatments.
Though patients would not be charged premiums, copays, or
deductibles, no healthcare funding mechanism was actually included in the
legislation.
Not All Democrats Are
Onboard with Medicare for All
Though more than 100 democratic lawmakers in the House of Representatives are co-sponsoring HR 1384, the legislation has failed to win over key Democrats, including House Budget Committee Chairman John Yarmuth (D-Ky.), who criticized the bill for going beyond an expansion of the Medicare program.
“I don’t consider that to be Medicare for all. It’s universal healthcare, on demand, unlimited,” Yarmuth told The Hill. “It’s all single-payer, no private insurance. It’s a very different thing than Medicare.”
It’s no wonder some oppose HR 1384. The bill proposes to abolish the private health insurance industry, which employs upwards of a half a million people and covers 250 million Americans, noted TheNew York Times (NYT).
“[Health insurance] companies’ stocks are a staple of the
mutual funds that make up millions of Americans’ retirement savings. Such a
change would shake the entire healthcare system, which makes up a fifth of the
United States economy, as hospitals, doctors, nursing homes, and pharmaceutical
companies would have to adapt to a new set of rules,” the NYT added.
Shifting Attitudes
Concerning National Healthcare Impact All Healthcare Providers
The legislation is unlikely to become law—especially since
single-payer healthcare is not likely to gain traction in the
Republican-controlled Senate. Nevertheless, HR 1384 has vaulted “Medicare for All”
from a fringe policy proposal to a front-and-center national debate among 2020
Democratic presidential hopefuls.
Democracy for America (DFA)—a one-million-member political action committee—labeled the proposed legislation “the new gold standard” for healthcare transformation.
“Congresswoman Jayapal’s bill establishes a new gold standard in the fight for a practical, cost-efficient way to provide a single standard of quality healthcare to everyone,” DFA CEO Yvette Simpson stated in a press release.
Many health providers disagree. The concept of single-payer
healthcare system faces strong opposition from hospitals and health insurers,
which are likely to remain a formidable roadblock to universal healthcare.
A single-payer healthcare system also would result in a massive spending shift, according to a study conducted by the Mercatus Center at George Mason University. The study’s author, Charles Blahous, PhD, states that Medicare for All (M4A) “would place unprecedented strain on the federal budget.”
“M4A would add approximately $32.6 trillion to
federal budget commitments during the first 10 years of its implementation
(2022–2031).
“This projected increase in federal healthcare
commitments would equal approximately 10.7% of GDP in 2022. This amount would
rise to nearly 12.7% of GDP in 2031 and continue to rise thereafter.
“These estimates are conservative because they assume the
legislation achieves its sponsors’ goals of dramatically reducing payments to
health providers, in addition to substantially reducing drug prices and
administrative costs,” he continues.
“A doubling of all currently projected federal individual
and corporate income tax collections would be insufficient to finance the added
federal costs of the plan,” Blahous concluded.
Medicare for All does not appear primed for passage in
Congress. However, clinical laboratory administrators and pathologists should
note that single-payer healthcare is no longer a fringe idea within the
Democratic party. The concept seems to be steadily moving into the mainstream
of political debate. It is a debate with the potential to dramatically change
how clinical laboratories and anatomic pathology groups get paid for their
diagnostic testing services.
Lab100 is designed to be easily upgraded with the latest medical laboratory technologies for tracking patients’ health metrics and risk for chronic diseases
Mount Sinai Hospital
and Cactus, a New York City-based
design studio, are creating a hybrid clinical laboratory/research lab that uses
the latest diagnostic technologies to assess peoples’ health, provide them with
an overview of their current condition, and suggest lifestyle changes to
prevent future diseases.
Though still under development, Lab100 is an innovative approach to
modernizing annual physical/medical check-ups. It was created to empower
patients to track and understand their own health metrics and optimize their overall
health.
Lab100 looks at an individual’s medical history and measures
vital signs, blood analysis, anthropometrics, body
composition, cognition, dexterity, strength, and balance. It’s designed to be
more extensive than the traditional, annual physical, as well as to support the
implementation of preventative measures to avoid disease.
8-Station Clinical
Laboratory Built for Future Expansion
Lab100 consists of eight stations that are built on a
reconfigurable grid system that ensures the system can easily be upgraded with new
technology as it becomes available.
“By definition, no one knows what the future of healthcare
is, and neither do we. We made our best initial guess, recognizing that we’re
going to change based on the data we collect,” David Stark, MD, the
Director and founder of Lab100, told Business Insider. “It may turn out
that we jettison some of these stations and put in additional stations.”
“We’re trying to give patients more visibility, not only into their health, but into how healthcare happens with the hope that that visibility engages them as patients,” David Stark, MD, MS (above), Director and founder of Lab100, told Business Insider. Should Lab100 prove successful, it could become a model for future similar medical laboratories nationwide. [Photo copyright: Business Insider.]
Before visiting Lab100 patients complete a pre-visit
assessment consisting of standardized medical surveys including medical
history, nutritional habits, physical activity, mental health, and sleep
habits. With patients’ consent, individual data are shared with a select group
of researchers to potentially power new discoveries.
Lab100’s eight stations and their purposes are:
Station
One: A patient’s photograph is taken to put a face with the medical record.
The picture also allows researchers to perform more speculative work by
extracting facial features and correlating them with health metrics.
Station
Two: The patient’s vital signs (temperature, height, weight, blood
pressure, pulse, and oxygen levels) are taken.
Station
Three: A venous blood sample is extracted to measure electrolytes, nutrient,
and cholesterol levels. Patients do not need to fast for the blood draw. The
blood test is analyzed onsite and the results are available within 30
minutes.
Station
Four: The patient steps on a 3D full-body scanner where a depth-sensing
camera scans the body and creates a high-resolution 3D avatar of the
individual.
Station
Five: A body composition test is performed using bioelectrical
impedance analysis. A small electrical current is run through the body to
determine the distribution of water, fat, protein, and minerals in the body and
to measure how muscle and fat are distributed throughout the body.
Station
Six: Cognition is
analyzed using a traditional pegboard dexterity test. To perform this test, a
patient dons headphones and interacts with an Apple iPad to test vocabulary,
processing speed, flexibility, episodic memory, and attention.
Station
Seven: The patient’s overall strength is measured by utilizing virtual
reality to determine grip strength and push the patient to give their maximum
performance.
Station
Eight: The patient steps onto a balance pod to test their balance. An iPod
with an accelerometer
placed around the patient’s waist measures sway as the individual tries to stay
as still as possible.
The entire Lab100 process takes about 90 minutes and is one-on-one between patient and physician. Test results at each of the eight stations are held until the end of the visit where they are cumulatively displayed on a screen for the patient and physician to review. Blood analyses are included in patients’ work-ups. (Photos copyright: Lab100.)
Engaging Patients in
Their Own Healthcare
When patients complete their Lab100 experience, they should
have a better understanding of their current health and any changes they can make
in their lives to improve their health and possibly avoid future disease. The
results allow a patient to learn their risks for some diseases and whether
interventions—such as changes in diet and exercise—could alter those risks.
“The idea here is not to obsess over every number, but to
holistically look at what’s going well, what isn’t going well, and come away
with one to three domains that you as the patient want to focus on,” Stark
noted.
The initial Lab100 visit serves as a baseline for comparing
with future visits to measure improvements as a result of lifestyle changes. It
also allows patients to compare their health metrics to others in the same age
range.
Lab 100 is still in the testing stages and could be
available to the public later this year. It is not intended to be a replacement
for primary care and does not diagnose disease. It is intended to serve as a
complement to a traditional office visit and focuses on preventative measures
to avoid illness. The researchers involved in the Lab100 project hope the
environment can ultimately be used to produce new diagnostics, therapeutics, and
tools for measuring health.
Researchers stress the importance of preparing hospital and clinical laboratory information systems before a ‘major failure’ occurs
Medical laboratory information systems (LIS) and similar devices are vulnerable to hacking, according to physicians and computer scientists from the University of California San Diego (UCSD) and the University of California Davis (UCD). They recently completed a study that exposed the vulnerabilities of these systems and revealed how clinical laboratory test results can be manipulated and exploited to put patient lives at risk.
Clinical laboratories hold large volumes of patient protected health information (PHI) in their electronic health record (EHR) systems. And it’s widely understood that medical laboratory test data comprises as much as 80% of patients’ permanent medical records. Therefore, medical laboratory stakeholders and managers could be held accountable should those medical records and databases be violated by computer hackers.
Researchers at the University of California San Diego (UCSD) used a man-in-the-middle attack (illustrated above) to intercept and modify data transmitted from a laboratory information system to an electronic medical record system. Clinical laboratories could be held responsible for such intrusion into patients’ protected health information (PHI) should it be determined that adequate safeguards were not implemented. (Caption and image copyrights: UCSD.)
To demonstrate their findings, the researchers hacked a test system made up of medical laboratory computers, servers, and testing devices. They then performed blood and urinalysis testing, intercepted and altered the normal blood test results to make it appear that the patient suffered from diabetic ketoacidosis (DKA), and then forwarded the modified results to the patient’s electronic medical records.
Such
misdiagnoses could lead physicians to prescribe incorrect medicines and
procedures that could injure or even kill patients.
“As a physician, I aim to educate my colleagues that the implicit trust we place in the technologies and infrastructure we use to care for our patients may be misplaced, and that an awareness of and vigilance for these threat models is critical for the practice of medicine in the 21st century,” Jeffrey Tully, MD (left), stated in the UCSD news release. Christian Dameff, MD (right), agreed, saying, “We are talking about this because we are trying to secure healthcare devices and infrastructure before medical systems experience a major failure. We need to fix this now.” (Photo copyright: University of Arizona News.)
In their paper, the researchers proposed “three viable strategies to ensure increased security and integrity of data in clinical environments, which we hope will be taken into consideration by the healthcare community:
“Secure network deployment: network segmentation, VLANs, and firewall controls: This is the most viable option for legacy systems and healthcare providers with budgetary and operational constraints. By restricting the attack surface of vulnerable devices to Ethernet networks inaccessible to outside influence, the potential for attack is largely mitigated. This, however, requires the intervention and trust of an experienced IT professional. When legacy devices that lack security controls exist in the network environment, isolation of these devices into network segments to minimize exposure is key.
“Proper configuration: In situations where the hospital network cannot be made completely secure through use of network segmentation, the alternative is proper configuration of servers and devices that support encryption. This would mean, for example, ensuring that the interface client, such as Mirth connect, is updated to its most recent version and the communication channels are set up to use encryption.
“Security conscious protocols and ecosystems: Moving forward, device manufacturers, care providers, standards organizations, and policy makers must push to incorporate newer protocols and ecosystems where strong security guarantees are built in, and actively look for these guarantees. One such example is the Fast Healthcare Interoperability Resources (FHIR), a replacement for HL7 which has greater potential for encryption. Without the development of a security conscious culture, healthcare infrastructure will remain vulnerable to malefaction.”
Cyberhacking of patient medical records is a critical issue. According to American Nurse Today, more than 16 million patient records were stolen from US healthcare organizations in 2016. In addition, more than 150 million individuals have had their medical records stolen since 2010. The majority of these thefts were the result of attacks against electronic health records (EHRs).
As
security breaches become more prevalent, it’s imperative that medical
laboratories and anatomic pathology groups take steps to secure their
information systems, testing devices, and patients’ records from cyberhacking. All
healthcare providers should familiarize themselves with cybersecurity methods
and protocols to defend their systems from remote attacks.
A digital camera or smartphone visualizes bioluminescent characteristics of test sample to display levels of Phe in blood, potentially giving medical laboratories a way to support home-based or point of care metabolite tests
Clinical laboratories may soon have a new paper-based finger prick assay that can quickly measure metabolites in blood samples and enable patients who need to monitor certain conditions, such as congenital phenylketonuria, to do so at home.
The test also could be used at the point of care and in remote regions where larger, medical laboratory technology for monitoring metabolites in blood is limited.
Molecular Biosensor
Measures Multiple Metabolites in Blood
“We introduce a fundamentally new mechanism to measure metabolites for blood analysis. Instead of miniaturizing available technology for point-of-care applications, we developed a new molecular tool,” said Qiuliyang Yu, PhD, first author of the paper and scientist at the Department of Chemical Biology at the Max Planck Institute in Heidelberg, in the news release.
In their study, the scientists primarily measured concentration of phenylalanine (Phe) in blood. However, their technology also could be used to monitor glucose and glutamate quantities as well, Medgadetreported.
“The sensor system successfully generated point-of-care
measurements of phenylalanine, glucose, and glutamate. The approach makes any
metabolite that can be oxidized by the cofactor a candidate for quantitative
point of care assays,” the authors wrote in Science.
As shown above, a mixture of the patient’s blood and the reaction buffer is applied onto a paper covered with the immobilized biosensor. The following reaction is detected with a digital camera and analyzed. (Photo and caption copyrights: Max Planck Institute for Medical Research.)
Red is a sign of high Phe concentration and blue low Phe;
The assay takes 15 minutes to perform.
“We have developed light-emitting sensor proteins to report
the concentration of the cofactor NADPH through which many medical metabolites
can be quantified. Because of the bioluminescent nature of the paper, we can
capture the signal—even in blood,” Yu states in the video.
This video demonstrates how the new biosensor works. The process the researchers developed for detecting and measure quantities of Phe in blood involves light-emitting engineered protein and the use of a digital camera or smartphone. During the process a color shift takes place that can be measured to determine the amount of Phe in the blood, Engineering 360 explained. Click here to watch the video. (Video copyright: Max Planck Society/YouTube.)
People Need Faster Test
Answers
More studies are needed before patients use can use the
assay do their own metabolite measurement blood tests. And the scientists say
they plan to simplify and automatize the test.
However, the researchers feel such fast measurements are
needed since many diseases cause changes in blood metabolites. Conventional clinical
laboratory blood tests do help patients to stay on top of their conditions. But
the sooner they can get results, the quicker patients can make necessary
changes in diet and more, the authors note.
“Monitoring metabolites at the point of care could improve
the diagnosis and management of numerous diseases. Yet for most metabolites,
such assays are not available. We introduce semisynthetic, light-emitting
sensor proteins for use in paper-based metabolic assays,” the researchers wrote
in Science.
Medical laboratory leaders may find it interesting to see a POC test with performance similar to tests using sophisticated medical laboratory technology. In fact, Yu makes that point as he stands in front of liquid chromatography-mass spectrometry (LC-MS) equipment in the aforementioned video.
Could the paper-based biosensor one day be preferred by doctors
and patients who need to monitor metabolites? People residing in remote or
rural areas where patient care centers are not so plentiful may appreciate and
need such a tool. And patients may prefer the convenience of doing it themselves
and getting fast answers, rather than visiting a clinical laboratory and
waiting days for results. Either way, these developments are worth following.
